Brush, Stephen

Carrizosa, Santiago :

McGuire Dr, Patrick E

Wright, Brian

IUCN Environmental Law Programme Accessing Accessing Biodiversity and Sharing the Beneï¬쳌ts:Biodiversity IUCN â?? The World Conservation Union Lessons from Implementing the Founded in 1948 , The World Conservation Union brings together States , government agencies and a diverse range of non - governmental organizations in a unique world Convention on Biological Diversity and partnership : over 1000 members in all , spread across some 140 countries . As a Union , IUCN seeks to inï¬?uence , encourage and assist societies throughout the Sharing world to conserve the integrity and diversity of nature and to ensure that any use of natural Edited by Santiago Carrizosa , Stephen B . Brush , resources is equitable and ecologically sustainable . A central Secretariat coordinates the Brian D . Wright , and Patrick E . McGuire IUCN Programme and serves the Union membership , representing their views on the the world stage and providing them with the strategies , services , scientiï¬쳌c knowledge and technical support they need to achieve their goals . Through its six Commissions , IUCN Beneï¬쳌ts : draws together over 10,000 expert volunteers in project teams and action groups , focusing in particular on species and biodiversity conservation and the management of habitats and natural resources . The Union has helped many countries to prepare National Conservation Strategies , and demonstrates the application of its knowledge through the ï¬쳌eld projects Lessons it supervises . Operations are increasingly decentralized and are carried forward by an expanding network of regional and country ofï¬쳌ces , located principally in developing countries . The World Conservation Union builds on the strengths of its members , networks and from partners to enhance their capacity and to support global alliances to safeguard natural resources at local , regional and global levels . Implementing IUCN Environmental Law Programme the Environmental Law Centre Convention Godesberger Allee 108 - 112 53175 Bonn , Germany Tel : + 49 228 2692231 Fax : + 49 228 2692250 E - mail : elcsecretariat @ iucn.org www.iucn.org / themes / law on Biological IUCN Publications Services Unit 219c Huntingdon Road Cambridge CB3 0DL United Kingdom Tel : + 44 1223 277894 Diversity Fax : + 44 1223 277175 E - mail : info @ books.iucn.org www.iucn.org / bookstore IUCN Environmental Policy and Law Paper No . 54 Accessing Biodiversity and Sharing the Benefits : Lessons from Implementing the Convention on Biological Diversity With the support of : G Genetic Resources Conservation Program R University of California C USA P Accessing Biodiversity and Sharing the Benefits : Lessons from Implementing the Convention on Biological Diversity Edited by Santiago Carrizosa , Stephen B . Brush , Brian D . Wright , and Patrick E . McGuire IUCN Environmental Policy and Law Paper No . 54 IUCN Environmental Law Programme IUCN â?? The World Conservation Union 2004 The designation of geographical entities in this book , and the presentation of the material , do not imply the expression of any opinion whatsoever on the part of î?? î?° î?? î?? , the University of California Genetic Resources Conservation Program ( GRCP ) , or the German Federal Ministry for Economic Cooperation and Development ( BMZ ) concerning the legal status of any country , territory , or area , or of its authorities , or concerning the delimitation of its frontiers or boundaries . The views expressed in this publication do not necessarily reflect those of IUCN , GRCP , or BMZ . This publication has been made possible by funding from IUCN , BMZ , GRCP , and the University of California Pacific Rim Research Program , California USA . Published by : IUCN , Gland , Switzerland and Cambridge , UK , in collaboration with BMZ , Germany and GRCP , University of California , Davis CA USA G R C P Copyright : © ï?? ï?? ï?? ï?? International Union for Conservation of Nature and Natural Resources Reproduction of this publication for educational or other noncommercial purposes is authorized without prior written permission from the copyright holder provided the source is fully acknowledged . Reproduction of this publication for resale or other commercial purposes is pro - hibited without prior written permission of the copyright holders . Citation : Carrizosa , Santiago , Stephen B . Brush , Brian D . Wright , and Patrick E . McGuire ( eds . ) 2004 . Accessing Biodiversity and Sharing the Benefits : Lessons from Implementation of the Convention on Biological Diversity . IUCN , Gland , Switzerland and Cambridge , UK . xiv + 316 pp . ISBN : 2 - 8317 - 0816 - 8 Cover design by : IUCN Environmental Law Centre Cover photo : Strawberry anemone ( Corynactis californica ) in Pacific coastal waters at Monterey Bay , California / Photo by Santiago Carrizosa Layout by : Patrick E . McGuire , GRCP Produced by : IUCN Environmental Law Centre Printed by : medienHaus Plump GmbH , ï?? ï?? ï?? ï?? ï?? Rheinbreitbach , Germany Available from : IUCN Publications Services Unit 219c Huntingdon Road , Cambridge CB3 0DL , United Kingdom Tel : + 44 1223 277894 Fax : + 44 1223 277175 E - mail : books @ iucn.org www.iucn.org / bookstore A catalogue of IUCN publications is also available . The text of this book is printed on paper made from low chlorine pulp . v Table of Contents Foreword . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ix Acknowledgements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xi List of Abbreviations and Acronyms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xii Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Santiago Carrizosa Regional Significance and î?? î?? î?¬ Frameworks â?¢ p ï?? ; Problem Statement â?¢ p ï?? ; Study Design and Organization of this Report â?¢ p ï?? Overview of the International Treaty on Plant Genetic Resources for Food and Agriculture ( ITPGRFA ) â?¢ Box 1 : p ï?? â?? ï?? Manuel Ruiz Chapter 1 . Diversity of Policies in Place and in Progress . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Santiago Carrizosa Overview of Regional and National ABS Policies and Laws â?¢ p ï?? ; Analyzing ABS Policies and Laws of Selected Countries â?¢ p ï?? ï?? ; Final Comments â?¢ p ï?? ï?? Chapter 2 . Scenarios of Policymaking Process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51 Santiago Carrizosa Policymaking Process and Main Concerns : Case Studies â?¢ p ï?? ï?? ; Policymaking Process : Analysis â?¢ p ï?? ï?? ; Final Comment â?¢ p ï?? ï?? Chapter 3 . Implementation Pathways . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67 Stephen B . Brush and Santiago Carrizosa The Road Towards Implementation of ABS Law and Policies â?¢ p ï?? ï?? ; Case Studies â?¢ p ï?? ï?? ; Lessons â?¢ p ï?? ï?? Chapter 4 . Colombia : Access and Exchange of Genetic Resources . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79 Paola Ferreira - Miani National Biodiversity Policy and National Biodiversity Strategy andAction Plan â?¢ p ï?? ï?? ; Identification and Definition of Access Laws and Policies â?¢ p ï?? ï?? ; Description of Legislation Relevant to ABS â?¢ p ï?? ï?? ; Process that Led to the Development of Decision ï?? ï?? ï?? â?¢ p ï?? ï?? ; Difficulties During the Design of Decision ï?? ï?? ï?? â?¢ p ï?? ï?? ; Implementation of Decision ï?? ï?? ï?? in Colombia â?¢ p ï?? ï?? ; Intellectual Property Rights and Bioprospecting â?¢ p ï?? ï?? ; Recommendations to Facilitate Access to Genetic Resources in other Countries â?¢ p ï?? ï?? v Chapter 5 . Costa Rica : Legal Framework and Public Policy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101 Jorge Cabrera - Medaglia Identification of Relevant Access Laws and Policies â?¢ p ï?? ï?? ï?? ; Main Characteristics of the Law of Biodiversity â?¢ p ï?? ï?? ï?? ; Analysis of the Process that Led to the Development of the LB â?¢ p ï?? ï?? ï?? ; Main Difficulties and Successes Experienced in the Design of the LB â?¢ p ï?? ï?? ï?? ; Identification and Analysis of the Difficulties and Successes in the Implementation of the LB â?¢ p ï?? ï?? ï?? ; The Role of the LB in Hampering or Facilitating Access to the Countryâ??s Genetic Resources â?¢ p ï?? ï?? ï?? ; Intellectual Property Rights â?¢ p ï?? ï?? ï?? ; Lessons Learned and Recommendations â?¢ p ï?? ï?? ï?? Chapter 6 . Mexico : Between Legality and Legitimacy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123 Jorge Larson - Guerra , Christian López - Silva , Francisco Chapela , José Carlos Fernández - Ugalde and Jorge Soberón Legal Basis for Access and Benefit Sharing in Mexican Law â?¢ p ï?? ï?? ï?? ; Social and Cultural Context for ABS â?¢ p ï?? ï?? ï?? ; Three Bioprospecting Projects in Mexico â?¢ p ï?? ï?? ï?? ; Future Access and Benefit - Sharing Regulatory Framework â?¢ p ï?? ï?? ï?? ; Conclusions and Recommendations â?¢ p ï?? ï?? ï?? Chapter 7 . Philippines : Evolving Access and Benefit - Sharing Regulations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 153 Paz J . Benavidez II Pre - EO ï?? ï?? ï?? Access Regulation â?¢ p ï?? ï?? ï?? ; Executive Order ï?? ï?? ï?? â?¢ p ï?? ï?? ï?? ; The Wildlife Act â?¢ p ï?? ï?? ï?? ; Intellectual Property Rights : Protection for Biological and Genetic Resources and Traditional Knowledge â?¢ p ï?? ï?? ï?? ; Access to Indigenous Peoples â?? Biological Resourcs and Traditional Knowledge â?¢ p ï?? ï?? ï?? ; Equitable Sharing of Benefits â?¢ p ï?? ï?? ï?? ; ASEAN Protocol on Access to Genetic Resources â?¢ p ï?? ï?? ï?? ; Conclusions and Recommendations â?¢ p ï?? ï?? ï?? Chapter 8 . The United States of America : The National Park Experience . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 177 Preston T . Scott National Parks as Living Laboratories â?¢ p ï?? ï?? ï?? ; The Value of Biological Research and the Law â?¢ p ï?? ï?? ï?? ; NPS Genetic Resource Access Management â?¢ p ï?? ï?? ï?? ; Conclusion â?¢ p ï?? ï?? ï?? Chapter 9 . Australia : Draft Regulations on Access and Benefit Sharing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 201 Sally Petherbridge Draft Access and Benefit - Sharing Regulations â?¢ p ï?? ï?? ï?? ; The Main Characteristics of the Draft Regulations on Access and Benefit Sharing â?¢ p ï?? ï?? ï?? ; The Process Leading to the Development of the Access Legislation â?¢ p ï?? ï?? ï?? ; Difficulties and Successes Experienced During the Design of the Draft Regulations â?¢ p ï?? ï?? ï?? ; Bioprospecting Initiatives â?¢ p ï?? ï?? ï?? ; Biodiversity Conservation , Sustainable Use , and Benefit - Sharing Strategies â?¢ p ï?? ï?? ï?? ; The CBD , TRIPS , and the ITPGRFA â?¢ p ï?? ï?? ï?? ; Conclusions â?¢ p ï?? ï?? ï?? vi vii Chapter 10 . Chile : Early Attempts to Develop Access and Benefit - Sharing Regulations . . . . . . . . . . . . . . . . . . . . . 227 Luis Flores - Mimiça and Dominique Hervé - Espejo Analysis of the Legal , Institutional , and Political Situation of Genetic Resources in Chile â?¢ p ï?? ï?? ï?? ; Bioprospecting Projects in Chile â?¢ p ï?? ï?? ï?? ; Conclusions â?¢ p ï?? ï?? ï?? Chapter 11 . Malaysia : Recent Initiatives to Develop Access and Benefit - Sharing Regulations . . . . . . . . . . . 243 Mohamad Osman Ownership of Genetic Resources and the Federal - State Jurisdictional Dichotomy â?¢ p ï?? ï?? ï?? ; Implementation of the CBD in Malaysia â?¢ p ï?? ï?? ï?? ; Current Measures that Regulate Access â?¢ p ï?? ï?? ï?? ; Analysis of the Process that led to the Development of the Access to Genetic Resources Bill â?¢ p ï?? ï?? ï?? ; Access to Genetic Resources Bill ( The Future Access Law ) â?¢ p ï?? ï?? ï?? ; Bioprospecting Projects â?¢ p ï?? ï?? ï?? ; Intellectual Property Rights and theAgreement on Trade - RelatedAspects of Intellectual Property Rights â?¢ p ï?? ï?? ï?? ; The FAO International Undertaking and the International Treaty on Genetic Resources for Food andAgriculture â?¢ p ï?? ï?? ï?? ; Early Lessons and Recommendations that can be Identified from the Process Leading to the Development of the Access Law or Policy â?¢ p ï?? ï?? ï?? ; Conclusions â?¢ p ï?? ï?? ï?? Chapter 12 . Legal Issues Regarding the International Regime : Objectives , Options , and Outlook . . . . . 271 Tomme Rosanne Young Opening Comments : The International Regime â?¢ p ï?? ï?? ï?? ; The Current Situation : î?? î?? î?¬ and the Bonn Guidelines â?¢ p ï?? ï?? ï?? ; Why Revise / Reconsider the International Regime ? â?¢ p ï?? ï?? ï?? ; Concepts Insufficiently Clarified â?¢ p ï?? ï?? ï?? ; AssumptionsInsufficientlyConsidered â?¢ p ï?? ï?? ï?? ; ExpectationsInsufficientlyRealized â?¢ p ï?? ï?? ï?? ; Conclusions and Recommendations â?¢ p ï?? ï?? ï?? Chapter 13 . Conclusions , Lessons , and Recommendations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 295 Santiago Carrizosa Complex Issues â?¢ p ï?? ï?? ï?? ; Complex Stakeholders â?¢ p ï?? ï?? ï?? ; Complex Policymaking and Implementation Scenarios â?¢ p ï?? ï?? ï?? ; Future Scenarios â?¢ p ï?? ï?? ï?? Appendix 1 . Conclusions from an International Workshop . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 303 Appendix 2 . Biographical Sketches of Authors and Editors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 307 Appendix 3 . Contact Information of Primary Contributors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 311 vi vii ix Foreword Modern developments in biotechnology and the continu - of the status of national ï쳌¡ ï쳌¢ ï쳌³ policy and legislation con - ing expansion of global trade have allowed society to gain ducted to date . Clearly the aim of this fruitful partnership greater access to , and to derive benefits from , the worldâ??s and process is not to present a consensus document . It is , biological and genetic diversity . Eleven years ago the however , an important publication with valuable insights Convention on Biological Diversity ( ï쳌£ ï쳌¢ ï쳌¤ ) entered into that will contribute not only to the development and refine - force , with a goal of ensuring that in the process of obtain - ment of national ï쳌¡ ï쳌¢ ï쳌³ policies , but also to the consideration ing and sharing such benefits , society would promote the of any future international regime on ï쳌¡ ï쳌¢ ï쳌³ . conservation and sustainable use of the worldâ??s biological This publication would not have been possible with - diversity . Since then countries have been attempting to in - out the generous support of the University of California corporate the ï쳌£ ï쳌¢ ï쳌¤ objectives into national legislation , with Pacific Rim Research Program , the ï쳌¡ ï쳌¢ ï쳌³ Project ( ï쳌© ï쳌µ ï쳌£ ï쳌® - varying success from country to country . Several Pacific ï쳌¥ ï쳌¬ ï쳌£ ) , the German Ministry for Economic Cooperation and Rim nations were pioneers in the development of access Development ( ï쳌¢ ï쳌­ ï쳌º ) , and ï쳌µ ï쳌£ ï쳌§ ï쳌² ï쳌£ ï쳌° . It is being published and benefit - sharing ( ï쳌¡ ï쳌¢ ï쳌³ ) laws and policies and faced a by ï쳌© ï쳌µ ï쳌£ ï쳌® due to the recognition by Tomme Young ( Senior wide variety of technical and legal difficulties in designing Legal Officer with ï쳌© ï쳌µ ï쳌£ ï쳌® - ï쳌¥ ï쳌¬ ï쳌£ , ï쳌¡ ï쳌¢ ï쳌³ Project ) of the value of and implementing novel access rules and regulations . having this knowledge reach as broad an international audi - As countries struggle with creating ï쳌¡ ï쳌¢ ï쳌³ regimes and ence as possible . The initiative and the product itself can be implementing them , they find a dearth of information about attributed to Santiago Carrizosa ( ï쳌µ ï쳌£ ï쳌§ ï쳌² ï쳌£ ï쳌° ) who conceived the process and the experience of others . The purpose of it , obtained funding for it , identified and solicited quality this book is to start to address this vacuum , by providing a responses and text from the more than ï?? ï?? participating comparative analysis of national ï쳌¡ ï쳌¢ ï쳌³ legislation and poli - experts , and then carried out a masterful comparative cies in the ï?? ï?? Pacific Rim countries that signed the ï쳌£ ï쳌¢ ï쳌¤ . analysis of the results . The ï쳌¡ ï쳌¢ ï쳌³ Project of the Environmental Law Center at the We are grateful to all of the experts who contributed World Conservation Union ( ï쳌© ï쳌µ ï쳌£ ï쳌® - ï쳌¥ ï쳌¬ ï쳌£ ) and the University to the publication , which reflects their own professional of California Genetic Resources Conservation Program views and not necessarily those of the supporting orga - ( ï쳌µ ï쳌£ ï쳌§ ï쳌² ï쳌£ ï쳌° ) are pleased to present the results of a three - year nizations . process of cooperation , consultation , and analysis that in - Patrick McGuire , Director , UC GRCP volved more than ï?? ï?? ï쳌¡ ï쳌¢ ï쳌³ experts from all the Pacific Rim countries that signed the ï쳌£ ï쳌¢ ï쳌¤ . This is the broadest survey John Scanlon , Director , IUCN - ELC ix xi Acknowledgements This volume is a testimony to the dynamic and changing comments are Paz J . Benavidez , Susan Bragdon , Will nature of ï쳌¡ ï쳌¢ ï쳌³ laws and policies in the ï?? ï?? Pacific Rim coun - Burns , Geoff Burton , Jorge Cabrera - Medaglia , Fernando tries that signed the Convention on Biological Diversity . Casas , Kimberlee Chambers , Leif Christoffersen , Matthew The multiple findings , insights , and perspectives presented Cohen , Adi Damania , Morgane Danielou , Jade Donavanik , in this report are a snapshot in time that was initiated in David Duthie , Oâ??Kean Ehmes , José Carlos Fernández - late ï?? ï?? ï?? ï?? and culminated in mid - ï?? ï?? ï?? ï?? . This process of col - Ugalde , Luis Flores , Marco Gonzales , Anne Haira , Jil laboration and consultation would not have been possible Harkin , Dominique Hervé , Leonard P . Hirsch , Timothy J . without the support of two grants from the University of Hodges , Vainuupo Jungblut , Stephen King , Laura Lewis , California Pacific Rim Research Program and financial Mohamed bin Osman , María Isabel Manzur , Tetiro Mate , support from the Environmental Law Center ( ï쳌¥ ï쳌¬ ï쳌£ ) of the James Miller , Vera Monshetseva , Karina Nabors , Doug World Conservation Union ( ï쳌© ï쳌µ ï쳌£ ï쳌® ) . We owe a particular Neumann , Valerie Normand , Coral Pasisi , Amanda Penn , debt of gratitude to TommeYoung ( ï쳌¡ ï쳌¢ ï쳌³ Project and ï쳌© ï쳌µ ï쳌£ ï쳌® - Jeanine Pfeiffer , Sally Petherbridge , Anne Perrault , Silvia ï쳌¥ ï쳌¬ ï쳌£ ) and Florence Mou ( University of California Pacific Rodríguez , Joshua Rosenthal , Manuel Ruiz , Preston Scott , Rim Research Program ) whose support to our research Breana Smith , Sourioudong Sundara , Brendan Tobin , Eric made possible the publication of our findings . The compi - Van Dusen , Joe Vogel , B . Satyawan Wardhana , Dayuan lation and understanding of the intricacies of ï쳌¡ ï쳌¢ ï쳌³ laws and Xue , and Tomme Young . policies was possible thanks to the insights and expertise Our efforts to understand the complexities of access of over ï?? ï?? academics , scientists , and policy makers from and benefit - sharing policies were greatly aided by many the Pacific Rim region who are listed in Appendices ï?? colleagues and friends who contributed ideas , experience , and ï?? of this publication . A special thanks goes to Jorge and encouragement to this project . In particular we are Cabrera , Carolina Lasén , and Manuel Ruiz who read draft grateful to Kelly Banister , Doug Calhoun , Tagaloa Cooper , chapters patiently and thoroughly and provided helpful and Kate Davis , Holly Doremus , Maria Elisa Febres , Elisabeth insightful comments that improved their quality . Gaibor , Lyle Glowka , Douveri Henao , Chaweewan Huta - During ï?? ï?? ï?? ï?? and ï?? ï?? ï?? ï?? preliminary results of our charern , Javier Guillermo Hernandez , Sarah Laird , Jorge research were discussed at five international workshops Larson - Guerra , Antonio LaViña , Christian Lopéz - Silva , and seminars that addressed î?? î?? î?¬ issues and we benefited Clark Peteru , Calvin Qualset , Mary Riley , Kerry ten Kate , from the comments of many participants . Three of these Claudia Sobrevila , and Cedric Schuster . events were held in the United States of America , one Santiago Carrizosa in Chile and the other one in Indonesia . Inevitably , we Stephen B . Brush are unable to acknowledge the names of all the persons Brian D . Wright that provided input at these events and for this we are Patrick E . McGuire regretful . Some of the participants that provided useful xi List of Abbreviations and Acronyms ABS . . . . . . . . . . . . . . . . . . . Access and benefit sharing COP . . . . . . . . . . . . . . . . . . . Conference of the Parties AG . . . . . . . . . . . . . . . . . . . . Attorney - Generalâ??s Chambers ( Malaysia ) CRA . . . . . . . . . . . . . . . . . Commercial Research Agreement ( Philippines ) AHWG . . . . . . . . . . . . . Ad Hoc Open - Ended Working Group CRADA . . . . . . . . . . . . Cooperative Research and Development AIMS . . . . . . . . . . . . . . . . Australian Institute of Marine Science Agreement ( USA ) ANAM . . . . . . . . . . . . . National Authority for the Environment CSIRO . . . . . . . . . . . . . . Commonwealth Scientific and Industrial ( Panama ) Research Organization ( Australia ) ANZECC . . . . . . . . . . Australian and New Zealand Environment and CSWG . . . . . . . . . . . . . . Commonwealth - State Working Group Conservation Council ( Australia ) APPTMI . . . . . . . . . . Act on Protection and Promotion of DA . . . . . . . . . . . . . . . . . . . . Department of Agriculture ( Philippines ) Traditional Medicinal Intelligence ( Thailand ) DAFF . . . . . . . . . . . . . . . Department of Agriculture , Fisheries and ARA . . . . . . . . . . . . . . . . . Academic Research Agreement ( Philippines ) Forestry ( Australia ) ASEAN . . . . . . . . . . . . Association of Southeast Asian Nations DAO . . . . . . . . . . . . . . . . . DENR Administrative Order ( Philippines ) ASOEN . . . . . . . . . . . . Senior Officials on Environment ( Philippines ) DENR . . . . . . . . . . . . . . . Department of Environment and Natural ASOMPS . . . . . . . . . Asian Symposium on Medicinal Plants , Resources ( Philippines ) Species and Other Natural Products DLSE . . . . . . . . . . . . . . . . Department of Lands , Surveys and ( Philippines ) Environment ( Samoa ) ATCC . . . . . . . . . . . . . . . American Type Culture Collection ( USA ) DNP . . . . . . . . . . . . . . . . . . Departamento Nacional de Planeacion BFAR . . . . . . . . . . . . . . . Bureau of Fisheries and Aquatic Resources ( Colombia ) ( Philippines ) DNWP . . . . . . . . . . . . . . Department of National Parks , Wildlife , and BTG . . . . . . . . . . . . . . . . . . British Technology Group ( Costa Rica ) Plant Conservation ( Thailand ) CABSSBR . . . . . . . Conditions for Access to and Benefit Sharing DOA . . . . . . . . . . . . . . . . . Department of Agriculture ( Malaysia ) of Samoaâ??s Biodiversity Resources DOF . . . . . . . . . . . . . . . . . . Department of Fisheries ( Malaysia ) CALM . . . . . . . . . . . . . . Department of Conservation and Land DOST . . . . . . . . . . . . . . . Department of Science and Technology Management ( Australia ) ( Philippines ) CBD . . . . . . . . . . . . . . . . . . . Convention on Biological Diversity ECOSUR . . . . . . . . . . El Colegio de la Frontera Sur ( Mexico ) CITES . . . . . . . . . . . . . . Convention on International Trade in EEEPGA . . . . . . . . . . Ecological Equilibrium and Environmental Endangered Species of Wild Fauna and Flora Protection General Act ( Mexico ) COABIO . . . . . . . . . . Advisory Commission on Biodiversity EIA . . . . . . . . . . . . . . . . . . . . . Environmental Impact Assessment ( Costa Rica ) EO 247 . . . . . . . . . . . . . . . Executive Order 247 ( The Philippines ) COMPITCH . . . . . Council of Indigenous and Traditional Medicine Men and Parteros ( Mexico ) EPA . . . . . . . . . . . . . . . . . . Queensland Environment Protection Agency ( Australia ) CONABIO . . . . . . . National Commission for the Knowledge and Use of Biodiversity ( Mexico ) EPBCA . . . . . . . . . . . . . Environment Protection and Biodiversity Conservation Act ( Australia ) CONAGEBIO National Commission for the Management of EPBCAR . . . . . . . . . . Environment Protection and Biodiversity Biodiversity ( Costa Rica ) Conservation Amendment Regulations CONADI . . . . . . . . . . National Corporation on Indigenous ( Australia ) Development ( Chile ) EPU . . . . . . . . . . . . . . . . . . Economic Planning Unit ( Malaysia ) CONAF . . . . . . . . . . . . National Forestry Corporation ( Chile ) ETC . . . . . . . . . . . . . . . . . . . . Action Group on Erosion , Technology and CONAMA . . . . . . . . . National Commission of the Environment Concentration ( Chile ) FAO . . . . . . . . . . . . . . . . . . . . United Nations Food and Agriculture CONICYT . . . . . . . . National Commission on Scientific and Organization Technological Research ( Chile ) xii xiii FCCC . . . . . . . . . . . . . . . United Nations Framework Convention on MOSTE . . . . . . . . . . . . Ministry of Science , Technology , and the Climate Change Environment ( Malaysia ) FECON . . . . . . . . . . . . Federation for the Conservation of the MOU . . . . . . . . . . . . . . . . Memorandum of Understanding Environment ( Costa Rica ) MTA . . . . . . . . . . . . . . . . . Material Transfer Agreement FIELD . . . . . . . . . . . . . . Foundation for International Environmental NASYCA . . . . . . . . . National System of Conservation Areas Law and Development ( Costa Rica ) FPIC . . . . . . . . . . . . . . . . . . . Free prior informed consent ( Philippines ) NBAP . . . . . . . . . . . . . . . National Biodiversity Action Plan FRIM . . . . . . . . . . . . . . . . . Forest Research Institute Malaysia NBP . . . . . . . . . . . . . . . . . . National Biodiversity Policy ( Colombia ) FTTA . . . . . . . . . . . . . . . . . . Federal Technology Transfer Act ( USA ) NBS . . . . . . . . . . . . . . . . . . National Biodiversity Strategy GAP . . . . . . . . . . . . . . . . . . General Access Procedure ( Costa Rica ) NBSAP . . . . . . . . . . . . . National Biodiversity Strategy and Action Plan GATT . . . . . . . . . . . . . . . . . General Agreement on Tariffs and Trade NCA . . . . . . . . . . . . . . . . . National Competent Authority ( Colombia ) GEF . . . . . . . . . . . . . . . . . . . . Global Environment Facility NCBD . . . . . . . . . . . . . . National Committee on Biological Diversity GLE . . . . . . . . . . . . . . . . . . General Law of the Environment No 41 ( Malaysia ) ( Panama ) NCI . . . . . . . . . . . . . . . . . . . . National Cancer Institute ( USA ) GLENR . . . . . . . . . . . . General Law of the Environment and Natural NEPA . . . . . . . . . . . . . . . . . National Environmental Policy Act ( USA ) Resources No . 217 ( Nicaragua ) NGO . . . . . . . . . . . . . . . . . . Nongovernmental organization GMAC . . . . . . . . . . . . . . Genetic Modification Advisory Committee NIH . . . . . . . . . . . . . . . . . . National Institutes of Health ( USA ) ( Malaysia ) NIPAS . . . . . . . . . . . . . . National Integrated Protected Areas System GMO . . . . . . . . . . . . . . . . Genetically modified organism ( Philippines ) GR . . . . . . . . . . . . . . . . . . . . Genetic resources NPS . . . . . . . . . . . . . . . . . . National Park Service ( USA ) IACBGR . . . . . . . . . . . Inter - Agency Committee on Biological and NRCT . . . . . . . . . . . . . . . National Research Council ( Thailand ) Genetic Resources ( Philippines ) NUMHP . . . . . . . . . . . . Nigerian Union of Medical Herbal Practitioners ICBG . . . . . . . . . . . . . . . . International Cooperative Biodiversity Group ODEPA . . . . . . . . . . . . . Agricultural Studies and Policies Office ICC . . . . . . . . . . . . . . . . . . . . . Indigenous Cultural Community ( Philippines ) ( Chile ) IDB . . . . . . . . . . . . . . . . . . . . Inter - American Development Bank OMIECH . . . . . . . . . . Organization of Indigenous Healers of the IFA . . . . . . . . . . . . . . . . . . . Institute of Fishing and Aquaculture State of Chiapas ( Mexico ) ( Costa Rica ) PACSD . . . . . . . . . . . . . Palawan Council for Sustainable IIE . . . . . . . . . . . . . . . . . . . . Queensland Information and Innovation Development ( Philippines ) Economy ( Australia ) PAMB . . . . . . . . . . . . . . . Protected Area Management Board INBio . . . . . . . . . . . . . . . . National Biodiversity Institute ( Costa Rica ) ( Philippines ) INDECOPI . . . . . . . National Institute for the Defense and PAWB . . . . . . . . . . . . . . . The Protected Areas and Wildlife Bureau Protection of Traditional Knowledge ( Peru ) ( Philippines ) INIA . . . . . . . . . . . . . . . . . National Institute for Agriculture Research PCSD . . . . . . . . . . . . . . . Philippine Council for Sustainable ( Chile ) Development IP . . . . . . . . . . . . . . . . . . . . . . Indigenous peoples PFE . . . . . . . . . . . . . . . . . . . Permanent Forest Estate ( Malaysia ) IPA . . . . . . . . . . . . . . . . . . . Intellectual Property Australia PIC . . . . . . . . . . . . . . . . . . . . . Prior informed consent IPA . . . . . . . . . . . . . . . . . . . Industrial Property Act ( Mexico ) PLM . . . . . . . . . . . . . . . . Pamantasan ng Lungsod ng Maynila IPAF . . . . . . . . . . . . . . . . . Integrated Protected Areas Fund ( Philippines ) ( Philippines ) IPC . . . . . . . . . . . . . . . . . . . Intellectual Property Code of the Philippines PROFEPA . . . . . . . . Federal Attorney for the Protection of the Environment ( Mexico ) IPRs . . . . . . . . . . . . . . . . . . Intellectual property rights PVPA . . . . . . . . . . . . . . . . Plant Variety Protection Act IPRA . . . . . . . . . . . . . . . . Indigenous Peoples â?? Rights Act ( Philippines ) QLD . . . . . . . . . . . . . . . . . State of Queensland ( Australia ) IRRDB . . . . . . . . . . . . . International Rubber Research and Development Board ( Malaysia ) RFD . . . . . . . . . . . . . . . . . . . Royal Forest Department ( Thailand ) ISIS . . . . . . . . . . . . . . . . . . Institute of Strategic and International Studies RFSRCFA . . . . . . . Regulation on Forestry Studying and ( Malaysia ) Research Conducting within Forested Areas ( Thailand ) ITPGRFA . . . . . . . . . International Treaty on Plant Genetic Resources for Food and Agriculture ( FAO ) RITM . . . . . . . . . . . . . . . . Research Institute for Tropical Medicine ( Philippines ) IUCN . . . . . . . . . . . . . . . . . The World Conservation Union RPRS . . . . . . . . . . . . . . . Research Proposal Reviewing Subcommittee JICA . . . . . . . . . . . . . . . . . Japan International Cooperation Agency ( Thailand ) LAUBGR . . . . . . . . . . . Law for Access and Use of Biological and RSDA . . . . . . . . . . . . . . . Rural Sustainable Development Act ( Mexico ) Genetic Resources ( Mexico ) SAG . . . . . . . . . . . . . . . . . . Agriculture and Livestock Service ( Chile ) LB . . . . . . . . . . . . . . . . . . . . Law of Biodiversity ( Costa Rica ) SEMARNAT . . . . Secretariat of Environment and Natural LC . . . . . . . . . . . . . . . . . . . . Letter of Collection Resources ( Mexico ) LI . . . . . . . . . . . . . . . . . . . . . . Letter of Intent SERNAPESCA Fishing Undersecretariat , the National Fishing LWC . . . . . . . . . . . . . . . . . Law of Wildlife Conservation ( Costa Rica ) Board ( Chile ) MARDI . . . . . . . . . . . . Malaysian Agricultural Research and SEPA . . . . . . . . . . . . . . . . Environmental Protection Administration Development Institute ( China ) MARENA . . . . . . . . Ministry for the Environment and Natural SFDGA . . . . . . . . . . . . Sustainable Forestry Development General Resources ( Nicaragua ) Act ( Mexico ) MINAE . . . . . . . . . . . . . Ministry of the Environment and Energy SPC . . . . . . . . . . . . . . . . . . South Pacific Commission ( Costa Rica ) SPDA . . . . . . . . . . . . . . . Peruvian Society for Environmental Law MIRENEM . . . . . . . Ministry of Natural Resources , Energy , and SPREP . . . . . . . . . . . . . . South Pacific Regional Environment Program Mines ( Costa Rica ) TAMA . . . . . . . . . . . . . . Traditional Alternative Medicine Act MNS . . . . . . . . . . . . . . . . . Malaysian Nature Society ( Philippines ) MOA . . . . . . . . . . . . . . . . Memorandum of Agreement ( Philippines ) TGRC . . . . . . . . . . . . . . . C.M . Rick Tomato Genetics Resource Center MOE . . . . . . . . . . . . . . . . . Ministry of Environment ( Colombia ) ( USA ) xii xiii TK . . . . . . . . . . . . . . . . . . . . Traditional knowledge TO . . . . . . . . . . . . . . . . . . . . Technical office ( Costa Rica ) TPVPA . . . . . . . . . . . . . Thai Plant Variety Protection Act TRIPS . . . . . . . . . . . . . . . . Agreement on Trade - Related Aspects of Intellectual Property Rights TS . . . . . . . . . . . . . . . . . . . . . Technical secretariat ( Philippines ) UKM . . . . . . . . . . . . . . . . Universiti Kebangsaan Malaysia UNAM . . . . . . . . . . . . . . . National Autonomous University of Mexico UNEP . . . . . . . . . . . . . . . . . United Nations Environment Programme UNU / IAS . . . . . . . . . United Nations University / Institute of Advanced Studies UP . . . . . . . . . . . . . . . . . . . . . . University of the Philippines UPM . . . . . . . . . . . . . . . . . Universiti Putra Malaysia UPOV . . . . . . . . . . . . . . . International Union for the Protection of New Varieties of Plants USA . . . . . . . . . . . . . . . . . . . United States of America USPTO . . . . . . . . . . . . . United States Patent and Trademark Office UZACHI . . . . . . . . . . . Zapotec and Chinantec Communities Union ( Mexico ) VSD . . . . . . . . . . . . . . . . . . Veterinary Services Department ( Malaysia ) WGA . . . . . . . . . . . . . . . . Wildlife General Act ( Mexico ) WIPO . . . . . . . . . . . . . . . World Intellectual Property Organization WRI . . . . . . . . . . . . . . . . . . World Resources Institute ( USA ) WSSD . . . . . . . . . . . . . . World Summit on Sustainable Development WTO . . . . . . . . . . . . . . . . . . World Trade Organization WWF . . . . . . . . . . . . . . . . World Wildlife Fund WWF - SPP . . . . . . . . World Wildlife Fund - South Pacific Program xiv Introduction Santiago Carrizosa Today , genetic resources are no longer the common achieved through a multilateral system of exchange of heritage of humankind and they cannot be treated as genetic resources . This access system is limited to plant freely accessible commodities . The ï?? ï?? ï?? ï?? United Nations genetic resources for food and agriculture ; access to ge - 1 Convention on Biological Diversity ( ï쳌£ ï쳌¢ ï쳌¤ ) and the ï?? ï?? ï?? ï?? netic resources for chemical , pharmaceutical , nonfood , and ï쳌¦ ï쳌¡ ï쳌¯ International Treaty on Plant Genetic Resources for nonagricultural uses would still be negotiated bilaterally in Food and Agriculture ( ï쳌© ï쳌´ ï쳌° ï쳌§ ï쳌² ï쳌¦ ï쳌¡ ) ( see Box ï?? ) recognized accordance with national ï쳌¡ ï쳌¢ ï쳌³ policies and the ï쳌£ ï쳌¢ ï쳌¤ . Initially , the sovereign rights of countries to control the use of their the exchange of germplasm of the food and forage crops genetic resources . These two agreements also stressed that listed in the ï쳌© ï쳌´ ï쳌° ï쳌§ ï쳌² ï쳌¦ ï쳌¡ Annex , and subject to modification , the authority to determine access to genetic resources will be regulated by this multilateral system ( ï쳌¦ ï쳌¡ ï쳌¯ ï?? ï?? ï?? ï?? ) . rests with national governments and is subject to national In April ï?? ï?? ï?? ï?? , the sixth Conference of the Parties to policies . The objectives of the ï쳌£ ï쳌¢ ï쳌¤ are the conservation of the ï쳌£ ï쳌¢ ï쳌¤ adopted the ï?? ï?? ï?? ï?? Bonn Guidelines on Access to biological diversity , its sustainable use , and the fair and eq - Genetic Resources and Fair and Equitable Sharing of the uitable sharing of benefits derived from the use of genetic Benefits Arising out of their Utilization ( hereafter , Bonn resources . Similarly , the objectives of the ï쳌© ï쳌´ ï쳌° ï쳌§ ï쳌² ï쳌¦ ï쳌¡ are the Guidelines on ï쳌¡ ï쳌¢ ï쳌³ ) . These guidelines apply to all genetic conservation , sustainable use , and equitable sharing of the resources covered by the ï쳌£ ï쳌¢ ï쳌¤ , with the exception of those benefits derived from plant genetic resources for food and covered by the ï쳌© ï쳌´ ï쳌° ï쳌§ ï쳌² ï쳌¦ ï쳌¡ . The guidelines are voluntary , flex - agriculture . This Treaty also stressed that these objectives ible , and were designed mainly to facilitate the develop - shall be accomplished by â?? linking this Treaty to the Food ment process of national ï쳌¡ ï쳌¢ ï쳌³ policies and contracts . The and Agriculture Organization of the United Nations and to guidelines outline the roles and responsibilities of users the Convention on Biological Diversity â?쳌 ( ï쳌¦ ï쳌¡ ï쳌¯ ï?? ï?? ï?? ï?? ) . and providers or genetic resources and encourage stake - The ï쳌£ ï쳌¢ ï쳌¤ , sometimes also called the â?? biotrade conven - holders to use a bilateral approach to facilitate ï쳌¡ ï쳌¢ ï쳌³ goals . tion â?쳌 , encouraged member countries to facilitate access The guidelines describe key issues that include : a ) involve - to genetic resources and take measures to ensure the fair ment of relevant stakeholders and capacity building ; b ) and equitable sharing of benefits derived from the use of steps in the ï쳌¡ ï쳌¢ ï쳌³ process ; c ) elements of a prior - informed - these resources . The ï쳌£ ï쳌¢ ï쳌¤ emphasized that access to genetic consent system ; d ) monetary and nonmonetary benefits ; resources should be on mutually agreed terms and subject e ) incentives ; f ) national monitoring and reporting ; and g ) to prior informed consent of the resource provider . Since accountability . In late ï?? ï?? ï?? ï?? , the Plan of Implementation the ï쳌£ ï쳌¢ ï쳌¤ came into force , bilateral agreements have been that came out of the Johannesburg World Summit on the main vehicle to facilitate access under the few national Sustainable Development ( ï쳌· ï쳌³ ï쳌³ ï쳌¤ ) recommended a ) the access and benefit - sharing ( ï쳌¡ ï쳌¢ ï쳌³ ) policies that were devel - promotion of the wide implementation of and continued oped to include the objectives and principles of the ï쳌£ ï쳌¢ ï쳌¤ . work on the ï?? ï?? ï?? ï?? Bonn Guidelines on ï쳌¡ ï쳌¢ ï쳌³ as an input for On the other hand , under the ï쳌© ï쳌´ ï쳌° ï쳌§ ï쳌² ï쳌¦ ï쳌¡ , ï쳌¡ ï쳌¢ ï쳌³ goals will be countries developing ï쳌¡ ï쳌¢ ï쳌³ policies and b ) the negotiation of ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ the development of an international regime to promote the failed to reach consensus and the debate continued at the fair and equitable sharing of benefits derived from the use seventh meeting of the Conference of the Parties ( ï쳌£ ï쳌¯ ï쳌° of genetic resources . In March ï?? ï?? ï?? ï?? , at the Open - Ended ï?? ) to the ï쳌£ ï쳌¢ ï쳌¤ in February ï?? ï?? ï?? ï?? . At ï쳌£ ï쳌¯ ï쳌° ï?? , delegates did Inter - Sessional Meeting on the Multi - Year Program of not resolve major issues such as the binding nature of Work for the Conference of the Parties to the ï쳌£ ï쳌¢ ï쳌¤ , delegates the international regime on ï쳌¡ ï쳌¢ ï쳌³ . However , they reached decided to broaden the mandate of the plan of implementa - consensus on the terms of reference for the international tion and included into the international regime the â?? access â?쳌 regime and mandated the ï쳌¡ ï쳌· ï쳌¨ ï쳌§ on ï쳌¡ ï쳌¢ ï쳌³ to develop and component in addition to benefit sharing . However , there negotiate the international regime on ï쳌¡ ï쳌¢ ï쳌³ based on the was disagreement about the legal nature of this regime . terms of reference . Members of the working group will Many developing countries called for a legally binding elaborate and negotiate the nature , scope , and elements of regime , but the United States of America ( ï쳌µ ï쳌³ ï쳌¡ ) stressed the international regime . Before ï쳌£ ï쳌¯ ï쳌° ï?? , the ï쳌¡ ï쳌· ï쳌¨ ï쳌§ on ï쳌¡ ï쳌¢ ï쳌³ that in Johannesburg the ï쳌· ï쳌³ ï쳌³ ï쳌¤ deliberately left out the will hold two sessions , one in Thailand and one in Spain . term â?? legally binding â?쳌 from the plan of implementation . The ï쳌¡ ï쳌¢ ï쳌³ regime will address strategies for the protection No agreement was reached at the meeting . In December of traditional knowledge . Therefore , the ï쳌¡ ï쳌· ï쳌¨ ï쳌§ on ï쳌¡ ï쳌¢ ï쳌³ ï?? ï?? ï?? ï?? , this and other issues about the international regime together with the Ad Hoc Open - Ended Inter - Sessional were debated further at the second meeting of the Ad Hoc Working Group on Article ï?? ( j ) of the ï쳌£ ï쳌¢ ï쳌¤ will examine sui Open - Ended Working Group ( ï쳌¡ ï쳌¨ ï쳌· ï쳌§ ) on ï쳌¡ ï쳌¢ ï쳌³ . Delegates generis systems , databases , registers , intellectual property Box 1 . Overview of the International Treaty on Plant Genetic Resources for Food and Agriculture ( ITPGRFA ) for Food and Agriculture adopted a revised Undertaking in Manuel Ruiz July ï?? ï?? ï?? ï?? ( http : / / www.fao.org / ag / cgrfa / IU.htm ) . This then The ï쳌© ï쳌´ ï쳌° ï쳌§ ï쳌² ï쳌¦ ï쳌¡ is a binding legal agreement adopted by the became the ï쳌© ï쳌´ ï쳌° ï쳌§ ï쳌² ï쳌¦ ï쳌¡ when adopted by consensus at the ï쳌¦ ï쳌¡ ï쳌¯ United Nations Food and Agriculture Organization ( ï쳌¦ ï쳌¡ ï쳌¯ ) headquarters in Rome in November ï?? ï?? ï?? ï?? . Conference on ï?? November ï?? ï?? ï?? ï?? . Despite the fact that the Objective and scope USA and Japan abstained from approving the treaty , there The ï쳌© ï쳌´ ï쳌° ï쳌§ ï쳌² ï쳌¦ ï쳌¡ objectives are â?? the conservation and sustainable were no votes against it . The USA , however , signed the treaty use of plant genetic resources for food and agriculture and the in November ï?? ï?? ï?? ï?? . Forty countries ( the minimum required for fair and equitable sharing of the benefits arising out of their its entry into force ) ratified , approved , accepted , or acceded to use , in harmony with the Convention on Biological Diversity , the ï쳌© ï쳌´ ï쳌° ï쳌§ ï쳌² ï쳌¦ ï쳌¡ and it entered into force on ï?? ï?? June ï?? ï?? ï?? ï?? . for sustainable development and food security â?쳌 ( Article ï?? . ï?? ) . Background Although its initial general provisions ( on conservation and The ï쳌© ï쳌´ ï쳌° ï쳌§ ï쳌² ï쳌¦ ï쳌¡ is the result of a long and complex process initi - sustainable use in general ) apply to all plant genetic resources ated in ï?? ï?? ï?? ï?? when the International Undertaking on Plant for food and agriculture , it is its access and benefit sharing Genetic Resources , a nonbinding legal instrument , was ap - ( ï쳌¡ ï쳌¢ ï쳌³ ) norms which are of particular relevance and interest in proved by ï쳌¦ ï쳌¡ ï쳌¯ Resolution ï?? / ï?? ï?? . The Undertaking reflected the context of the current international debate . the concerns of countries regarding access to and use of plant The ï쳌© ï쳌´ ï쳌° ï쳌§ ï쳌² ï쳌¦ ï쳌¡ entered into force in a context where multiple , genetic resources , the role of intellectual property , especially sometimes overlapping and even conflicting policies and leg - patents and plant breeders â?? rights as applied to biological islation on ï쳌¡ ï쳌¢ ï쳌³ are in place . It seems that existing ï쳌¡ ï쳌¢ ï쳌³ laws materials , the relation between sovereignty and the principle and policies such as the ï?? ï?? ï?? ï?? Decision ï?? ï?? ï?? of the Andean of â?? common heritage of mankind â?쳌 and small farmers â?? con - Community on a Common Regime on Access to Genetic tribution to the conservation of plant genetic resources ( later Resources and the ï?? ï?? ï?? ï?? Law of Biodiversity of Costa Rica reflected in the adoption by the Undertaking of the â?? Farmers â?? may have to be adjusted and amended in order to prevent Rights â?쳌 concept ) . Tensions and frictions were evident among conflicts with overall ï쳌© ï쳌´ ï쳌° ï쳌§ ï쳌² ï쳌¦ ï쳌¡ obligations and mandates . biodiversity - rich countries in the South and industrialized and Exchanging genetic resources and sharing the benefits technologically advanced but biodiversity - poor countries in The ï쳌© ï쳌´ ï쳌° ï쳌§ ï쳌² ï쳌¦ ï쳌¡ access provisions will operate through a Multi - the North . lateral System of Access and Benefit Sharing . Under this In ï?? ï?? ï?? ï?? , at the United Nations Conference on Environment System , standardized Material Transfer Agreements ( ï쳌­ ï쳌´ ï쳌¡ s ) , and Development ( ï쳌µ ï쳌® ï쳌£ ï쳌¥ ï쳌¤ ) , the Convention on Biological approved by the Treatyâ??s Governing Body , will determine Diversity ( ï쳌£ ï쳌¢ ï쳌¤ ) established a set of new binding principles conditions and requirements to facilitate access to an initial and rules applicable to access to genetic resources in general . number of ï?? ï?? food and forage crops . The System is based Agenda ï?? ï?? ( another outcome of ï쳌µ ï쳌® ï쳌£ ï쳌¥ ï쳌¤ ) specifically called on the fact that , in terms of plant genetic resources for food for the ï쳌¦ ï쳌¡ ï쳌¯ to both strengthen the Undertaking and harmonize and agriculture in particular , interdependence among coun - it with the ï쳌£ ï쳌¢ ï쳌¤ . In November ï?? ï?? ï?? ï?? , ï쳌¦ ï쳌¡ ï쳌¯ â?? s Resolution ï?? / ï?? ï?? tries and regions prevails and no country is self sufficient recognized the need to review the Undertaking as applied to individually to provide its agriculture system with plant plant genetic resources for food and agriculture in particular genetic resources for breeding , conservation , and food se - and develop a binding treaty in conformity with the ï쳌£ ï쳌¢ ï쳌¤ rules . curity purposes . In ï?? ï?? ï?? ï?? the process of revising the Undertaking was begun within the ï쳌¦ ï쳌¡ ï쳌¯ and the Commission on Genetic Resources Benefits from facilitated access under the ï쳌© ï쳌´ ï쳌° ï쳌§ ï쳌² ï쳌¦ ï쳌¡ will ï?? ï?? I ï쳌® ï쳌´ ï쳌² ï쳌¯ ï쳌¤ ï쳌µ ï쳌£ ï쳌´ ï쳌© ï쳌¯ ï쳌® rights ( ï쳌© ï쳌° ï쳌² s ) , and other measures that can contribute to the based on a natural template . Worldwide sales of these ï?? ï?? implementation of Article ï?? ( j ) . products reached about ï?? ï?? ï?? , ï?? ï?? ï?? million ï쳌µ ï쳌³ ï쳌¤ ( ï쳌´ ï쳌¥ ï쳌® K ï쳌¡ ï쳌´ ï쳌¥ While these working groups , member countries , and and L ï쳌¡ ï쳌© ï쳌² ï쳌¤ ï?? ï?? ï?? ï?? ) . Most of the sales were made by mul - signatories of the ï쳌£ ï쳌¢ ï쳌¤ and ï쳌© ï쳌´ ï쳌° ï쳌§ ï쳌² ï쳌¦ ï쳌¡ debate how to incorpo - tinationals such as Pfizer ( ï쳌µ ï쳌³ ï쳌¡ ) , GlaxoSmithKline ( ï쳌µ ï쳌« ) , rate into national policies this relatively new and complex Merck and Co . ( ï쳌µ ï쳌³ ï쳌¡ ) , Novartis ( Switzerland ) , and Bristol array of ï쳌¡ ï쳌¢ ï쳌³ concepts , some genetic resources are becom - Myers Squibb ( ï쳌µ ï쳌³ ï쳌¡ ) . In ï?? ï?? ï?? ï?? and ï?? ï?? ï?? ï?? , however , some ing more valuable as the agriculture , pharmaceutical , and pharmaceutical companies such as Merck have reduced or biotechnology industries continue to provide improved closed some of their natural products discovery programs means to assay and use them . The economic value of ( J . R ï쳌¯ ï쳌³ ï쳌¥ ï쳌® ï쳌´ ï쳌¨ ï쳌¡ ï쳌¬ , pers . comm . February ï?? ï?? ï?? ï?? , J . Cabrera , the information contained in the genes and biochemical pers . comm . February ï?? ï?? ï?? ï?? ) . compounds of genetic resources has increased with the de - These multinationals have an important market share velopment of novel technologies such as high - throughput in developing countries such as Chile and the Philippines . analysis , combinatorial chemistry , bioinformatics , and ge - However , countries such as China , Egypt , and India fa - nomics . In ï?? ï?? ï?? ï?? , ï?? ï?? of the top ï?? ï?? best - selling pharmaceuti - vor mainly their domestic pharmaceutical industries that cal products were either biologicals , natural products or manufacture almost exclusively generic drugs ( ï쳌´ ï쳌¥ ï쳌® K ï쳌¡ ï쳌´ ï쳌¥ entities derived from natural products , or synthetic versions and L ï쳌¡ ï쳌© ï쳌² ï쳌¤ ï?? ï?? ï?? ï?? ) . Counterfeiting of pharmaceutical and Box 1 . Continued be shared fairly and equitably among parties through : a ) Farmers â?? Rights exchange of information ; b ) access to and transfer of tech - As part of the Undertaking , Farmers â?? Rights were to be nology ; c ) capacity building ; and d ) sharing of monetary or implemented through an international fund to compensate commercial benefits from the use of resources . Under cur - small farmers for their conservation and development of plant rent national ï쳌¡ ï쳌¢ ï쳌³ laws and policies , monetary benefits are genetic resources efforts . Under the ï쳌© ï쳌´ ï쳌° ï쳌§ ï쳌² ï쳌¦ ï쳌¡ , Farmers â?? Rights negotiated bilaterally and they include royalty rates , up - front will be implemented at the national level through individual payments , and milestone payments . In the case of the ï쳌© ï쳌´ ï쳌° - government action ( Article ï?? ) . This may be undertaken either ï쳌§ ï쳌² ï쳌¦ ï쳌¡ , the sharing of monetary benefits is an issue which still through development of laws for the protection of traditional needs to be addressed and decided by the Governing Body . knowledge , the participation of indigenous peoples in the Being part of the System is already an important benefit for benefits derived from the use of plant genetic resources for countries ( Article ï?? ï?? ) . food and agriculture , or through participation of indigenous Ex situ conservation centers peoples in decision - making processes pertaining to these . Ex situ conservation centers ( especially the International In the last few years many countries may have actually been Agriculture Research Centers ) , hold an important portion implementing their ï쳌© ï쳌´ ï쳌° ï쳌§ ï쳌² ï쳌¦ ï쳌¡ obligation in regards to Farmers â?? of the worldâ??s collections of plant genetic resources for food Rights . The ï쳌£ ï쳌¢ ï쳌¤ , the ï쳌· ï쳌© ï쳌° ï쳌¯ Intergovernmental Committee on and agriculture . These are held â?? in trust â?쳌 for the benefit of Genetic Resources and Intellectual Property , Traditional humankind and were obtained mostly prior to the CBD en - Knowledge and Folklore , and other initiatives have triggered tering into force . These centers will sign agreements with a series of national and regional policy and legal processes the ï쳌© ï쳌´ ï쳌° ï쳌§ ï쳌² ï쳌¦ ï쳌¡ Governing Body ( to replace current agreements oriented at the protection of traditional knowledge in general . with ï쳌¦ ï쳌¡ ï쳌¯ ) which will determine the new policies and rules In the case of Peru for example , the ï?? ï?? ï?? ï?? Law ï?? ï?? ï?? ï?? ï?? for regarding access to and use of these materials . A specific ï쳌­ ï쳌´ ï쳌¡ the protection of indigenous peoples â?? traditional knowledge is under negotiation for this purpose . related to biodiversity will certainly be giving substantive Intellectual property ( IP ) content to the Farmers â?? Rights provisions of the ï쳌© ï쳌´ ï쳌° ï쳌§ ï쳌² ï쳌¦ ï쳌¡ . The ï쳌© ï쳌´ ï쳌° ï쳌§ ï쳌² ï쳌¦ ï쳌¡ recognizes that â?? access and transfer [ of plant Similarly , general provisions on the protection of traditional genetic resources ] shall be provided on terms which recognize knowledge in ï쳌¡ ï쳌¢ ï쳌³ laws in Costa Rica , Philippines , and a few and are consistent with the adequate and effective protection others , could also be indirectly addressing Farmers â?? Rights of intellectual property rights â?쳌 ( Article ï?? ï?? . ï?? . b.iii ) . Clearly there is an express recognition of the need to respect ï쳌© ï쳌° . On ( see Chapter ï?? ) . the other hand , ï쳌© ï쳌° ( whether patents or plant breeders â?? rights ) Final Word shall not be applied to plant genetic resources in the form Many countries are still analyzing the implications of the received from the Multilateral System ( Article ï?? ï?? . ï?? . d ) . It has Treaty on their national access regulations and intellectual not been decided whether this restriction of ï쳌© ï쳌° also applies property rights . One simple but sometimes politically dif - to components or derivatives of these resources . If patents ficult way to overcome potential problems is for countries were allowed over isolated components and depending on expressly to recognize ( as they develop their ï쳌¡ ï쳌¢ ï쳌³ policies how countries were to apply and interpret national and inter - and laws ) that the ï쳌© ï쳌´ ï쳌° ï쳌§ ï쳌² ï쳌¦ ï쳌¡ Multilateral System as it applies national ï쳌© ï쳌° rules , there could be certain restrictions regarding to the list of crops is an exceptional regime , with its own set access to and use of plant genetic resources for food and of rules and principles , which should not be affected by other agriculture containing these components or derivatives even if they are part of the Multilateral System . laws and regulations . ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ many other products is a common practice in these and portunities to biodiversity stakeholders from developing many other developing ( and developed ) countries that countries . They have also transferred technology required translates into significant economic losses for multina - to carry out specific tests and have provided incentives tionals . Therefore , these multinationals have lobbied to for the development of in situ and ex situ conservation prevent these activities and strengthen intellectual property activities ( R ï쳌¯ ï쳌³ ï쳌¥ ï쳌® ï쳌´ ï쳌¨ ï쳌¡ ï쳌¬ et al . ï?? ï?? ï?? ï?? , see Chapters ï?? , ï?? , and protection for their products all over the world in order ï?? ï?? ) . However , it is unrealistic to pretend that current and to recover their significant investments ( S ï쳌© ï쳌¥ ï쳌¢ ï쳌¥ ï쳌£ ï쳌« et al . future bioprospecting projects can be a significant source ï?? ï?? ï?? ï?? , R ï쳌¹ ï쳌¡ ï쳌® ï?? ï?? ï?? ï?? ) . These multinationals were particularly of funding for the conservation of biological diversity or effective during the ï?? ï?? ï?? ï?? â?? ï?? ï?? ï?? ï?? Uruguay Round of mul - a guaranteed means of generating , particularly in the short tilateral trade negotiations when the Agreement on Trade term , major levels of revenue ( S ï쳌© ï쳌­ ï쳌° ï쳌³ ï쳌¯ ï쳌® et al . ï?? ï?? ï?? ï?? ) . Costa 2 Related Aspects of Intellectual Property Rights ( ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ ) Rica , the only country in the world that has over a decade was adopted . Unlike the Convention of the International of documented experience implementing bioprospecting Union for the Protection of New Varieties of Plants ( ï쳌µ ï쳌° ï쳌¯ ï쳌¶ ) projects , has accumulated valuable data about the impact 3 or any other intellectual property rights treaty , ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ es - of these projects on conservation . Between ï?? ï?? ï?? ï?? and tablishes legal enforcement of minimum standards for all ï?? ï?? ï?? ï?? , these projects channeled about ï?? ï?? . ï?? million ï쳌µ ï쳌³ ï쳌¤ to ï쳌© ï쳌° ï쳌² s.According to ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ , member countries have to provide conservation purposes . This is equivalent to an average of patent protection for microorganisms ( as products ) and ï?? ï?? ï?? ï?? , ï?? ï?? ï?? ï쳌µ ï쳌³ ï쳌¤ per year , an amount which is quite insig - for nonbiological and microbiological processes used for nificant compared to the ï?? ï?? ï?? ï?? million ï쳌µ ï쳌³ ï쳌¤ per year that the production of plants and animals . Plants and animals Costa Rica gets from ecological tourism ( see Chapter ï?? ) . themselves may be excluded from patentability . However , Research and development for the production of pharma - plant varieties must be protected by plant breeders â?? rights ceuticals and other biotechnology products derived from or another sui generis system . ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ has a timetable for biodiversity can be a risky , costly , and time - consuming compliance . For example , the least developed countries activity ( D ï쳌© M ï쳌¡ ï쳌³ ï쳌© et al . ï?? ï?? ï?? ï?? , R ï쳌¥ ï쳌© ï쳌¤ et al . ï?? ï?? ï?? ï?? ) . have until ï?? ï?? ï?? ï?? to provide patent protection for pharma - Bioprospecting projects have been the target of heavy ceuticals ( ï쳌· ï쳌´ ï쳌¯ News ï?? ï?? ï?? ï?? ) . Failure to comply with this criticism in the last few years . Claims of biopiracy , unfair timetable might bring trade sanctions ( D ï쳌µ ï쳌´ ï쳌¦ ï쳌© ï쳌¥ ï쳌¬ ï쳌¤ ï?? ï?? ï?? ï?? ) . distribution of benefits , illegal appropriation of traditional In November ï?? ï?? ï?? ï?? , trade ministers from all over the knowledge , and the problem of the patenting of life have world adopted the Doha Ministerial Declaration in order contributed to revive the old south - north debate that fo - to facilitate the implementation of current agreements of cuses on access to genetic resources on the one hand and the World Trade Organization ( ï쳌· ï쳌´ ï쳌¯ ) , among other issues . the economic returns of using them on the other ( S ï쳌¨ ï쳌© ï쳌¶ ï쳌¡ The Declaration encourages the ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ Council to review ï?? ï?? ï?? ï?? , ï?? ï?? ï?? ï?? , see Chapter ï?? ) . The essence of the debate the relationship between ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ and the ï쳌£ ï쳌¢ ï쳌¤ and the protec - is that industrialized countries are the primary users and 4 tion of traditional knowledge and folklore . The outcome economic beneficiaries of genetic resources and traditional of this review is still unclear . However , several analysts knowledge that are â?? produced â?쳌 in developing countries . suggest that the impact of ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ on the ï쳌£ ï쳌¢ ï쳌¤ is strong , and The apparent solution to this disparity is to provide some they have challenged the patent scenario promoted by ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ legal and social mechanism for balancing inequities be - ( S ï쳌¨ ï쳌© ï쳌¶ ï쳌¡ ï?? ï?? ï?? ï?? ) . Indigenous communities and other sectors tween the north and south in access to genetic resources of society reject the idea of patenting life , and this position and financial benefits from using them . This mechanism has had direct and indirect consequences that include the has to be the result of a participatory process that involves 5 cancellation of bioprospecting projects ( S ï쳌¨ ï쳌© ï쳌¶ ï쳌¡ ï?? ï?? ï?? ï?? , see all sectors of society . Otherwise , as history has shown , Chapter ï?? ) . Others argue that patents should not be used to ï쳌¡ ï쳌¢ ï쳌³ initiatives are likely to fail ( see Chapter ï?? ) . This is the protect genes that have just been isolated in vitro because challenge faced by the policy makers and bioprospectors according to traditional patent law this is a discovery and who are designing ï쳌¡ ï쳌¢ ï쳌³ policies ( see Chapters ï?? , ï?? , and ï?? ) . 6 not an invention ( C ï쳌¯ ï쳌² ï쳌² ï쳌¥ ï쳌¡ ï?? ï?? ï?? ï?? , D ï쳌µ ï쳌´ ï쳌¦ ï쳌© ï쳌¥ ï쳌¬ ï쳌¤ ï?? ï?? ï?? ï?? , see These policies should promote the conservation , sustain - Chapter ï?? ) . On the other hand , many argue that when able use , and equitable distribution of the benefits derived patents are linked to bioprospecting agreements , they can from terrestrial and marine biodiversity . But they also need support local capacity building and conservation ( R ï쳌¥ ï쳌© ï쳌¤ et to facilitate the access and exchange of genetic resources al . ï?? ï?? ï?? ï?? , ï쳌´ ï쳌¥ ï쳌® K ï쳌¡ ï쳌´ ï쳌¥ and L ï쳌¡ ï쳌© ï쳌² ï쳌¤ ï?? ï?? ï?? ï?? ) . found in megadiversity countries that form the basis for Bioprospecting projects are long - term efforts whose the improvement of agricultural crops , for the develop - fruits could materialize perhaps ï?? ï?? or ï?? ï?? years into the ment of key medicines and pharmaceutical products , and future provided that products are developed and marketed . for crop - protection products that are fundamental to the In the short run , however , these projects can provide and survival of the worldâ??s population . have provided research , training , and educational op - ï?? ï?? I ï쳌® ï쳌´ ï쳌² ï쳌¯ ï쳌¤ ï쳌µ ï쳌£ ï쳌´ ï쳌© ï쳌¯ ï쳌® Regional Significance and ABS Frameworks The Pacific Rim countries include ï?? ï?? of the ï?? ï?? so - called species of flowering plants have been intensively exam - ined for possible medicinal value ( G ï쳌² ï쳌© ï쳌® ï쳌¤ ï쳌¬ ï쳌¥ ï쳌¹ ï?? ï?? ï?? ï?? ) . The megadiversity countries or the biologically wealthiest na - biotechnology industry has also used living organisms to tions of the world ( M ï쳌© ï쳌´ ï쳌´ ï쳌¥ ï쳌² ï쳌­ ï쳌¥ ï쳌© ï쳌¥ ï쳌² et al . ï?? ï?? ï?? ï?? ) . These ï?? ï?? 7 clean up polluted sites , to provide energy , and to separate countries cover only ï?? % of the worldâ??s continental surface valuable minerals from ore , among other uses ( ï쳌´ ï쳌¥ ï쳌® K ï쳌¡ ï쳌´ ï쳌¥ but harbor about ï?? ï?? % of the worldâ??s biodiversity . Many of and L ï쳌¡ ï쳌© ï쳌² ï쳌¤ ï?? ï?? ï?? ï?? ) . these nations are within centers of origin and diversity of Two years after the ï쳌£ ï쳌¢ ï쳌¤ came into force , a handful crops such as maize ( Mexico ) , potato ( Peru and Bolivia ) , of biodiversity - rich Pacific Rim countries pioneered the rice ( Philippines ) , and soybean ( China ) . The agricultural first comprehensive ï쳌¡ ï쳌¢ ï쳌³ frameworks in the world . In productivity of countries such as Australia and the ï쳌µ ï쳌³ ï쳌¡ is the Asian region of the Pacific Rim , the Philippines , a heavily dependent on a supply of genetic resources from megadiversity country , developed in ï?? ï?? ï?? ï?? the first ï쳌¡ ï쳌¢ ï쳌³ the Pacific Rim region ( ï쳌¦ ï쳌¡ ï쳌¯ ï?? ï?? ï?? ï?? ) . regime ( Chapter ï?? ) . Similarly , in mid - ï?? ï?? ï?? ï?? , the Andean Furthermore , Pacific Rim countries are also valuable 8 Community of Nations adopted Decision ï?? ï?? ï?? ( Chapter sources of genes and biochemicals that are currently ï?? ) , the first instance in which a group of biodiversity - rich used by the pharmaceutical and biotechnology industries countries realized that they had to act as a unit to enact in healthcare and agriculture . In the ï쳌µ ï쳌³ ï쳌¡ , ï?? ï?? % of the top legislation to protect common traditional knowledge and ï?? ï?? ï?? prescription drugs used in ï?? ï?? ï?? ï?? were nature - inspired ecological regions , in this case the Pacific Rim , the Andes , compounds , semisynthetics and their analogs , and natural and the Amazon region . Two years later , on ï?? ï?? April ï?? ï?? ï?? ï?? , products or chemicals found in nature . Only ï?? ï?? % were the Costa Rican government adopted the â?? Biodiversity completely human - made drugs.Almost ï?? ï?? % of these drugs Law â?쳌 which established ï쳌¡ ï쳌¢ ï쳌³ rules and procedures for come from plants , ï?? ï?? % from fungi , ï?? % from bacteria , and bioprospectors with commercial and academic purposes ï?? % from snake venom ( F ï쳌¡ ï쳌® ï쳌® ï쳌© ï쳌® ï쳌§ ï?? ï?? ï?? ï?? ) . Most of the con - ( Chapter ï?? ) . tributions of nature to the pharmaceutical industry come from plants , but only ï?? . ï?? to ï?? . ï?? % of the ï?? ï?? ï?? , ï?? ï?? ï?? known Problem Statement Since the ï쳌£ ï쳌¢ ï쳌¤ came into force in ï?? ï?? ï?? ï?? , designing legal national level . Some of these issues have been addressed . frameworks to regulate access to genetic resources has For example , in ï?? ï?? ï?? ï?? , a workshop at Columbia University been a central task in the realm of international environ - resulted in an interesting report that reviewed seven ex - mental policy . Political scientists , sociologists , economists , amples of bioprospecting agreements implemented in molecular biologists , ecologists , and scientists from many seven countries . Issues analyzed by the report included : other disciplines have contributed to the debate on the ï쳌£ ï쳌¢ ï쳌¤ , a ) stakeholders ; b ) property rights ; c ) prior informed con - ï쳌© ï쳌° ï쳌² s , bioprospecting initiatives , and contractual arrange - sent ; d ) benefit sharing ; e ) compliance ; and f ) biodiversity ments , and this information has contributed to the devel - conservation and sustainable use ( ï쳌¥ ï쳌° ï쳌³ ï쳌· ï?? ï?? ï?? ï?? ) . Similarly , opment of the first ï쳌¡ ï쳌¢ ï쳌³ frameworks . For example , R ï쳌¥ ï쳌© ï쳌¤ B ï쳌¡ ï쳌³ ï쳌³ and R ï쳌µ ï쳌© ï쳌º ( ï?? ï?? ï?? ï?? ) analyzed access policies within et al . ( ï?? ï?? ï?? ï?? ) and the C ï쳌² ï쳌µ ï쳌£ ï쳌© ï쳌¢ ï쳌¬ ï쳌¥ G ï쳌² ï쳌¯ ï쳌µ ï쳌° ( ï?? ï?? ï?? ï?? ) presented the context of conservation and sustainable use in seven valuable insights on the relationships among the ï쳌£ ï쳌¢ ï쳌¤ , the countries . G ï쳌¬ ï쳌¯ ï쳌· ï쳌« ï쳌¡ et al . ( ï?? ï?? ï?? ï?? ) published case studies International Undertaking of the ï쳌¦ ï쳌¡ ï쳌¯ , ï쳌© ï쳌° ï쳌² s , benefit - sharing of ï쳌¡ ï쳌¢ ï쳌³ policy progress in ï?? ï?? Southeast Asian countries strategies , and bioprospecting initiatives for pharmaceuti - and N ï쳌® ï쳌¡ ï쳌¤ ï쳌¯ ï쳌º ï쳌© ï쳌¥ et al . ( ï?? ï?? ï?? ï?? ) published a handbook that cal and agricultural purposes . The debate on the impact addresses laws , policies , and institutions that govern ï쳌¡ ï쳌¢ ï쳌³ of ï쳌© ï쳌° ï쳌² s on biodiversity conservation and traditional issues in ï?? ï?? African countries . But no comprehensive study knowledge promoted by V ï쳌¯ ï쳌§ ï쳌¥ ï쳌¬ ( ï?? ï?? ï?? ï?? ) , G ï쳌² ï쳌¥ ï쳌¡ ï쳌¶ ï쳌¥ ï쳌³ ( ï?? ï?? ï?? ï?? ) , has been conducted about the difficulties and successes S ï쳌· ï쳌¡ ï쳌® ï쳌³ ï쳌¯ ï쳌® ( ï?? ï?? ï?? ï?? ) , and B ï쳌² ï쳌µ ï쳌³ ï쳌¨ and S ï쳌´ ï쳌¡ ï쳌¢ ï쳌© ï쳌® ï쳌³ ï쳌« ï쳌¹ ( ï?? ï?? ï?? ï?? ) also that these and other nations experienced while developing influenced the development of recommendations for ï쳌¡ ï쳌¢ ï쳌³ their ï쳌¡ ï쳌¢ ï쳌³ frameworks . Moreover , no comparative analyses frameworks ( M ï쳌µ ï쳌§ ï쳌¡ ï쳌¢ ï쳌¥ et al . ï?? ï?? ï?? ï?? , ï쳌´ ï쳌¥ ï쳌® K ï쳌¡ ï쳌´ ï쳌¥ and L ï쳌¡ ï쳌© ï쳌² ï쳌¤ have been conducted on the experience this far of nations ï?? ï?? ï?? ï?? ) that still need to be tested . Others such as G ï쳌¬ ï쳌¯ ï쳌· ï쳌« ï쳌¡ that have engaged in the development and implementation ( ï?? ï?? ï?? ï?? ) and L ï쳌¡ ï쳌© ï쳌² ï쳌¤ ( ï?? ï?? ï?? ï?? ) have attempted to provide a menu of ï쳌¡ ï쳌¢ ï쳌³ policies . for the development of ï쳌¡ ï쳌¢ ï쳌³ frameworks . In ï?? ï?? ï?? ï?? , ï쳌£ ï쳌¯ ï쳌° ï?? of The Pacific Rim countries that pioneered the develop - the ï쳌£ ï쳌¢ ï쳌¤ adopted the ï?? ï?? ï?? ï?? Bonn Guidelines on ï쳌¡ ï쳌¢ ï쳌³ designed ment of ï쳌¡ ï쳌¢ ï쳌³ frameworks have faced a wide variety of tech - to help countries develop their access regulations . nical , political , social , and legal difficulties in designing However , over eight years have passed since the first and implementing novel ï쳌¡ ï쳌¢ ï쳌³ policies at a national level . access framework was adopted by the Philippines , and The Andean Pact countries , the Philippines , and Costa there are still many questions regarding the impact of this Rica , for example , have had problems ensuring that these and other policies regarding the exchange of genetic re - policies embody the principles of the ï쳌£ ï쳌¢ ï쳌¤ and at the same 9 sources and on the implementation of these policies at a time take into account the beliefs and opinions of key sec - ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ tors of society about how genetic resources and traditional access policies on ï쳌© ï쳌° ï쳌² issues , benefit - sharing strategies , and knowledge should be used and administered . Today , most bioprospecting initiatives for pharmaceutical , agricultural , of the economic value of genetic resources comes from and industrial purposes . The experience of these pioneer the information that they provide to the biotechnology countries will certainly facilitate the development of bal - industry , and regulating access to this information cre - anced and sound ï쳌¡ ï쳌¢ ï쳌³ policies . These policies might in turn ates challenges that many countries have never faced facilitate the exchange of genetic resources and benefits for before . These nations have also had conceptual , finan - many Pacific Rim countries whose unrestricted or misman - cial , and administrative difficulties in implementing their aged access to genetic resources has already led to unsound ï쳌¡ ï쳌¢ ï쳌³ policies at a national level ( P ï쳌¯ ï쳌® ï쳌£ ï쳌¥ ï쳌¤ ï쳌¥ L ï쳌¥ ï?³ ï쳌® ï?? ï?? ï?? ï?? , practices that have depleted a significant concentration of C ï쳌¡ ï쳌³ ï쳌¡ ï쳌³ ï?? ï?? ï?? ï?? , C ï쳌¡ ï쳌² ï쳌² ï쳌© ï쳌º ï쳌¯ ï쳌³ ï쳌¡ ï?? ï?? ï?? ï?? ) . Moreover , in countries species and ecosystems crucial for the survival of many such as Colombia , Ecuador , and Peru a lack of clarity local cultures and industries . We have undertaken this study about the implementation of key ï쳌¡ ï쳌¢ ï쳌³ laws has specifically to determine and address the problems of development prevented scientists from collecting plants and animals and implementation of ï쳌¡ ï쳌¢ ï쳌³ frameworks , the unexpected for noncommercial research purposes ( G ï쳌² ï쳌¡ ï쳌ª ï쳌¡ ï쳌¬ ï?? ï?? ï?? ï?? , consequences of ï쳌¡ ï쳌¢ ï쳌³ frameworks on bioprospecting proj - R ï쳌¥ ï쳌¶ ï쳌« ï쳌© ï쳌® ï?? ï?? ï?? ï?? ) . ects , and the lack of access to information among countries There is also a lack of information about the role of about ï쳌¡ ï쳌¢ ï쳌³ issues . Study Design and Organization of this Report In October ï?? ï?? ï?? ï?? , a preliminary overview of the results Many Pacific Rim countries share ecological similarities in large terrestrial and marine regions , and they also share of the study was presented at a workshop at the University 10 the need to regulate access to their rich genetic resources . of California , Davis . Forty - five experts on ï쳌¡ ï쳌¢ ï쳌³ issues There is already much experience in the region that can be from seventeen Pacific Rim countries , multilateral organi - shared not only among the Pacific Rim countries , but also zations involved in ï쳌£ ï쳌¢ ï쳌¤ implementation , nongovernmental between these countries and other non - Pacific Rim coun - organizations ( ï쳌® ï쳌§ ï쳌¯ s ) with ï쳌£ ï쳌¢ ï쳌¤ expertise , collections - based tries that may also be facing access concerns . Therefore , organizations , industry , and academia participated . The in early ï?? ï?? ï?? ï?? , with financial support from the University workshop provided an opportunity to identify the main of Californiaâ??s Pacific Rim Research Program , an effort elements and gaps of the existing international system was initiated to identify existing access frameworks , of ï쳌¡ ï쳌¢ ï쳌³ governance , the main elements of what a future benefit - sharing strategies , ï쳌© ï쳌° ï쳌² issues , and bioprospecting international regime on ï쳌¡ ï쳌¢ ï쳌³ should have , and measures initiatives in the Pacific Rim region and develop a com - that might be taken by the international community to parative analysis . Between ï?? ï?? ï?? ï?? and ï?? ï?? ï?? ï?? , over ï?? ï?? experts enhance effective international governance.A summary of from ï?? ï?? Pacific Rim countries that signed the ï쳌£ ï쳌¢ ï쳌¤ were the workshop conclusions is presented in Appendix ï?? . identified and contacted . Thirteen of them were asked to One of the participants was Tomme Young , Legal develop in - depth reports about the ï쳌¡ ï쳌¢ ï쳌³ legislation status , Officer at the Environmental Law Center of the World ï쳌© ï쳌° ï쳌² s , and bioprospecting projects of five countries that Conservation Union in Bonn , Germany . At the workshop have these type of policies in place and three countries she presented an analysis of elements for the future in - that are currently working on legal ï쳌¡ ï쳌¢ ï쳌³ frameworks . The ternational regime and she contributed an amplification forty - nine experts from the other ï?? ï?? countries were asked of that address here as Chapter ï?? ï?? . The chapter presents to respond to a survey . Specific issues that all of the experts an overview of the existing system of international ï쳌¡ ï쳌¢ ï쳌³ were asked to discuss included : a ) the process that led to governance , discusses the opportunities and challenges or will lead to the development of national ï쳌¡ ï쳌¢ ï쳌³ laws and facing the international community in negotiation of an policies ; b ) successes and concerns that countries experi - international regime , and suggests a potential blueprint , enced during the design of these regulations ; c ) successes in the form of proposed areas of action to clarify ï쳌¡ ï쳌¢ ï쳌³ and concerns experienced during the implementation of concepts and assumptions , upon which the international these regulations ; d ) influence of these frameworks and ï쳌© ï쳌° ï쳌² community may wish to focus in the development of an issues on bioprospecting initiatives ; and e ) novel benefit - effective international system of ï쳌¡ ï쳌¢ ï쳌³ governance . sharing strategies that have been implemented locally . This Finally , Chapter ï?? ï?? summarizes the main lessons report presents comparative analyses of the above issues learned from the study and their implications for the de - ( Chapters ï?? through ï?? ) and a selection of eight case stud - velopment of ï쳌¡ ï쳌¢ ï쳌³ frameworks . Appendix ï?? provides back - ies that show in detail the status and experiences of five ground information on authors and Appendix ï?? provides countries that have ï쳌¡ ï쳌¢ ï쳌³ frameworks and three countries contact information for authors and survey respondents . that are struggling to develop such frameworks ( Chapters ï?? through ï?? ï?? ) . ï?? ï?? I ï쳌® ï쳌´ ï쳌² ï쳌¯ ï쳌¤ ï쳌µ ï쳌£ ï쳌´ ï쳌© ï쳌¯ ï쳌® References B ï쳌¡ ï쳌² ï쳌´ ï쳌¯ ï쳌® J . ï?? ï?? ï?? ï?? . Introduction : Intellectual property rights G ï쳌² ï쳌¡ ï쳌ª ï쳌¡ ï쳌¬ A . ï?? ï?? ï?? ï?? . Biodiversity and the nation state : Regulating workshop . p . ï?? ï?? â?? ï?? ï?? in P.S . B ï쳌¡ ï쳌¥ ï쳌® ï쳌º ï쳌© ï쳌§ ï쳌¥ ï쳌² , R.A . K ï쳌¬ ï쳌¥ ï쳌¥ ï쳌³ ï쳌¥ , access to genetic resources limits biodiversity research in and R.F . B ï쳌¡ ï쳌² ï쳌® ï쳌¥ ï쳌³ ( eds . ) Intellectual property rights : developing countries . Conservation Biology ï?? ï?? : ï?? â?? ï?? . Protection of plant materials . CSSA Special Publication G ï쳌² ï쳌¥ ï쳌¡ ï쳌¶ ï쳌¥ ï쳌³ T . ( ed . ) ï?? ï?? ï?? ï?? . Intellectual property rights for No . ï?? ï?? , Crop Science Society of America , American indigenous peoples : A source book . Society for Applied Society of Agronomy . Soil Science Society of America , Anthropology , ï쳌¯ ï쳌« , ï쳌µ ï쳌³ ï쳌¡ . Madison , ï쳌· ï쳌© , ï쳌µ ï쳌³ ï쳌¡ . G ï쳌² ï쳌© ï쳌® ï쳌¤ ï쳌¬ ï쳌¥ ï쳌¹ J . ï?? ï?? ï?? ï?? . The natural approach to pharmaceuticals . B ï쳌¡ ï쳌³ ï쳌³ S . and M . R ï쳌µ ï쳌© ï쳌º . ï?? ï?? ï?? ï?? . Protecting biodiversity : National Scrip Magazine , December : ï?? ï?? - ï?? ï?? . laws regulating access to genetic resources in the L ï쳌¡ ï쳌© ï쳌² ï쳌¤ S . ( ed . ) ï?? ï?? ï?? ï?? . Biodiversity and traditional knowledge : Americas . International Development Research Center , Equitable partnerships in practice . Earthscan , London , ï쳌µ ï쳌« . Ottawa , Canada . M ï쳌© ï쳌´ ï쳌´ ï쳌¥ ï쳌² ï쳌­ ï쳌¥ ï쳌© ï쳌¥ ï쳌² R.A . , N . M ï쳌¹ ï쳌¥ ï쳌² ï쳌³ , P . R ï쳌¯ ï쳌¢ ï쳌¬ ï쳌¥ ï쳌³ - G ï쳌© ï쳌¬ , and C . B ï쳌¥ ï쳌® ï쳌´ S . , R . S ï쳌£ ï쳌¨ ï쳌· ï쳌¡ ï쳌¡ ï쳌¢ , D . C ï쳌¯ ï쳌® ï쳌¬ ï쳌© ï쳌® , and D . J ï쳌¥ ï쳌¦ ï쳌¦ ï쳌² ï쳌¥ ï쳌¹ . ï?? ï?? ï?? ï?? . M ï쳌© ï쳌´ ï쳌´ ï쳌¥ ï쳌² ï쳌­ ï쳌¥ ï쳌© ï쳌¥ ï쳌² - G ï쳌¯ ï쳌¥ ï쳌´ ï쳌´ ï쳌³ ï쳌£ ï쳌¨ ( eds . ) ï?? ï?? ï?? ï?? . The hotspots . Intellectual property rights in biotechnology worldwide . ï쳌£ ï쳌¥ ï쳌­ ï쳌¥ ï쳌¸ . ï쳌µ ï쳌³ ï쳌¡ . Stockton Press , ï쳌® ï쳌¹ , ï쳌µ ï쳌³ ï쳌¡ . M ï쳌µ ï쳌§ ï쳌¡ ï쳌¢ ï쳌¥ J . , C.V . B ï쳌¡ ï쳌² ï쳌¢ ï쳌¥ ï쳌² , G . H ï쳌¥ ï쳌® ï쳌® ï쳌¥ , L . G ï쳌¬ ï쳌¯ ï쳌· ï쳌« ï쳌¡ , and A . L ï쳌¡ B ï쳌² ï쳌µ ï쳌³ ï쳌¨ S.B . and D . S ï쳌´ ï쳌¡ ï쳌¢ ï쳌© ï쳌® ï쳌³ ï쳌« ï쳌¹ ( eds . ) ï?? ï?? ï?? ï?? . Valuing local V ï쳌© ï?± ï쳌¡ ( eds . ) ï?? ï?? ï?? ï?? . Access to genetic resources : Strategies knowledge : Indigenous people and intellectual property for sharing benefits . Environmental Law Center , ï쳌© ï쳌µ ï쳌£ ï쳌® , rights . Island Press , ï쳌£ ï쳌¡ , ï쳌µ ï쳌³ ï쳌¡ . Nairobi , Kenya . C ï쳌¡ ï쳌² ï쳌² ï쳌© ï쳌º ï쳌¯ ï쳌³ ï쳌¡ S . ï?? ï?? ï?? ï?? . La bioprospección y el acceso a los N ï쳌® ï쳌¡ ï쳌¤ ï쳌¯ ï쳌º ï쳌© ï쳌¥ K . , R . L ï쳌¥ ï쳌´ ï쳌´ ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¯ ï쳌® , C . B ï쳌² ï쳌µ ï쳌£ ï쳌¨ , S . B ï쳌¡ ï쳌³ ï쳌³ , and recursos genéticos . ( Bioprospecting and access to genetic S . K ï쳌© ï쳌® ï쳌§ ï쳌¢ ï쳌¹ ( eds . ) ï?? ï?? ï?? ï?? . African perspectives on ge - resources ) . Con la colaboración de Adriana Casas . La netic resources : A handbook on laws , policies , and Corporación Autónoma Regional de Cundinamarca ( ï쳌£ ï쳌¡ ï쳌² ) , institutions . African Union Scientific , Technical and Bogotá , Colombia . Research Commission , the Southern Environmental C ï쳌¡ ï쳌³ ï쳌¡ ï쳌³ A . ï?? ï?? ï?? ï?? . Recursos genéticos : Biodiversidad y dere - and Agricultural Policy Research Institute , and the cho . ( Genetic resources : Biodiversity and law ) . Instituto Environmental Law Institute , Washington ï쳌¤ ï쳌£ , ï쳌µ ï쳌³ ï쳌¡ . Colombiano de Derecho Ambiental , Ediciones Jurídicas P ï쳌¯ ï쳌® ï쳌£ ï쳌¥ ï쳌¤ ï쳌¥ L ï쳌¥ ï?³ ï쳌® E . ï?? ï?? ï?? ï?? . Concepto sobre propiedad de Gustavo Ibañez , Bogotá , Colombia . recursos genéticos en la legislación colombiana ( Opinion C ï쳌¯ ï쳌² ï쳌² ï쳌¥ ï쳌¡ C.M . ï?? ï?? ï?? ï?? . Access to plant genetic resources and on the concept of property over genetic resources in intellectual property rights . Background Study Paper Colombian law ) . p . ï?? ï?? ï?? â?? ï?? ï?? ï?? in Grupo ad hoc sobre diver - No . ï?? . Commission on Genetic Resources for Food and sidad biológica , ï쳌© ï쳌¬ ï쳌³ ï쳌¡ , ï쳌© ï쳌§ ï쳌¥ ï쳌¡ , and ï쳌· ï쳌· ï쳌¦ ( eds . ) Diversidad Agriculture , ï쳌¦ ï쳌¡ ï쳌¯ , Rome , Italy . biologica y cultural : Retos y propuestas desde America C ï쳌² ï쳌µ ï쳌£ ï쳌© ï쳌¢ ï쳌¬ ï쳌¥ G ï쳌² ï쳌¯ ï쳌µ ï쳌° . ï?? ï?? ï?? ï?? . People , plants and patents : The Latina . ( Cultural and biological diversity : Challenges and impact of intellectual property on biodiversity conserva - proposals from Latin America ) . ï쳌© ï쳌¬ ï쳌³ ï쳌¡ . Bogotá , Colombia . tion , trade and rural society . International Development Reid W.V . , S.A . L ï쳌¡ ï쳌© ï쳌² ï쳌¤ , R . G ï?¡ ï쳌­ ï쳌¥ ï쳌º , A . S ï쳌© ï쳌´ ï쳌´ ï쳌¥ ï쳌® ï쳌¦ ï쳌¥ ï쳌¬ ï쳌¤ , D.H . Research Center , Ottawa , Canada . J ï쳌¡ ï쳌® ï쳌º ï쳌¥ ï쳌® , M.G . G ï쳌¯ ï쳌¬ ï쳌¬ ï쳌© ï쳌® , and C . J ï쳌µ ï쳌­ ï쳌¡ . ï?? ï?? ï?? ï?? . A new lease D ï쳌µ ï쳌´ ï쳌¦ ï쳌© ï쳌¥ ï쳌¬ ï쳌¤ G . ï?? ï?? ï?? ï?? . Intellectual property rights , trade and on life . p . ï?? â?? ï?? ï?? in W.V . R ï쳌¥ ï쳌© ï쳌¤ , S.A . L ï쳌¡ ï쳌© ï쳌² ï쳌¤ , C.A . M ï쳌¥ ï쳌¹ ï쳌¥ ï쳌² , biodiversity . Earthscan , London , ï쳌µ ï쳌« . R . G ï?¡ ï쳌­ ï쳌¥ ï쳌º , A . S ï쳌© ï쳌´ ï쳌´ ï쳌¥ ï쳌® ï쳌¦ ï쳌¥ ï쳌¬ ï쳌¤ , D.H . J ï쳌¡ ï쳌® ï쳌º ï쳌¥ ï쳌® , M.G . G ï쳌¯ ï쳌¬ ï쳌¬ ï쳌© ï쳌® , and C . J ï쳌µ ï쳌­ ï쳌¡ ( eds . ) . Biodiversity prospecting : Using F ï쳌¡ ï쳌® ï쳌® ï쳌© ï쳌® ï쳌§ O . ï?? ï?? ï?? ï?? . New survey shows majority of drugs origi - genetic resources for sustainable development . World nate in nature as well as in laboratory . Internal Medicine . Resources Institute , Washington ï쳌¤ ï쳌£ ï쳌µ ï쳌³ ï쳌¡ . World Report , May ï?? ï?? â?? ï?? ï?? . R ï쳌¥ ï쳌¶ ï쳌« ï쳌© ï쳌® A.C . ï?? ï?? ï?? ï?? . Biologists sought a treaty : Now they fault D ï쳌© M ï쳌¡ ï쳌³ ï쳌© J.A . , R.W . H ï쳌¡ ï쳌® ï쳌³ ï쳌¥ ï쳌® , H.G . G ï쳌² ï쳌¡ ï쳌¢ ï쳌¯ ï쳌· ï쳌³ ï쳌« ï쳌© , and L . it . The New York Times , May ï?? . L ï쳌¡ ï쳌³ ï쳌¡ ï쳌§ ï쳌® ï쳌¡ . ï?? ï?? ï?? ï?? . Cost of innovations in the pharmaceuti - cal industry . Journal of Health Economics ï?? ï?? : ï?? ï?? ï?? â?? ï?? ï?? ï?? . R ï쳌¯ ï쳌³ ï쳌¥ ï쳌® ï쳌´ ï쳌¨ ï쳌¡ ï쳌¬ J.P . , D . B ï쳌¥ ï쳌£ ï쳌« , A . B ï쳌¨ ï쳌¡ ï쳌´ , J . B ï쳌© ï쳌³ ï쳌· ï쳌¡ ï쳌³ , L . B ï쳌² ï쳌¡ ï쳌¤ ï쳌¹ , K . B ï쳌² ï쳌© ï쳌¤ ï쳌¢ ï쳌¯ ï쳌¡ ï쳌² ï쳌¤ , S . C ï쳌¯ ï쳌¬ ï쳌¬ ï쳌© ï쳌® ï쳌³ , G . C ï쳌² ï쳌¡ ï쳌§ ï쳌§ , J . E ï쳌¤ ï쳌· ï쳌¡ ï쳌² ï쳌¤ ï쳌³ , A . ï쳌¥ ï쳌° ï쳌³ ï쳌· . ï?? ï?? ï?? ï?? . Access to genetic resources : An evaluation of the F ï쳌¡ ï쳌© ï쳌² ï쳌¦ ï쳌© ï쳌¥ ï쳌¬ ï쳌¤ , M . G ï쳌¯ ï쳌´ ï쳌´ ï쳌¬ ï쳌© ï쳌¥ ï쳌¢ , L.A . G ï쳌³ ï쳌£ ï쳌¨ ï쳌· ï쳌© ï쳌® ï쳌¤ , Y . H ï쳌¡ ï쳌¬ ï쳌¬ ï쳌¯ ï쳌£ ï쳌« , development and implementation of recent regulation R . H ï쳌¡ ï쳌· ï쳌« ï쳌³ , R . H ï쳌¥ ï쳌§ ï쳌¹ ï쳌¥ ï쳌¬ ï쳌© , G . J ï쳌¯ ï쳌¨ ï쳌® ï쳌³ ï쳌¯ ï쳌® , G.T . K ï쳌¥ ï쳌µ ï쳌³ ï쳌£ ï쳌¨ , E.E . and access agreements . Environmental Policy Studies L ï쳌¹ ï쳌¯ ï쳌® ï쳌³ , R . M ï쳌© ï쳌¬ ï쳌¬ ï쳌¥ ï쳌² , J . R ï쳌¯ ï쳌¤ ï쳌­ ï쳌¡ ï쳌® , J . R ï쳌¯ ï쳌³ ï쳌« ï쳌¯ ï쳌³ ï쳌« ï쳌© , and D . Workshop , Working Paper # ï?? , School of International and S ï쳌© ï쳌¥ ï쳌§ ï쳌¥ ï쳌¬ - C ï쳌¡ ï쳌µ ï쳌³ ï쳌¥ ï쳌¹ . ï?? ï?? ï?? ï?? . Combining high risk science with Public Affairs , Columbia University , ï쳌® ï쳌¹ , ï쳌µ ï쳌³ ï쳌¡ . ambitious social and economic goals . Pharmaceutical ï쳌¦ ï쳌¡ ï쳌¯ . ï?? ï?? ï?? ï?? . The state of the worldâ??s plant genetic resources for Biology ï?? ï?? : ï?? â?? ï?? ï?? . food and agriculture . ï쳌¦ ï쳌¡ ï쳌¯ , Rome , Italy . R ï쳌¹ ï쳌¡ ï쳌® M.P . ï?? ï?? ï?? ï?? . Knowledge diplomacy : Global competi - ï쳌¦ ï쳌¡ ï쳌¯ . ï?? ï?? ï?? ï?? . International treaty on plant genetic resources for tion and the policies of intellectual property . Brookings food and agriculture . ï쳌¦ ï쳌¡ ï쳌¯ , Rome , Italy . Institution Press , Washington ï쳌¤ ï쳌£ , ï쳌µ ï쳌³ ï쳌¡ . G ï쳌¬ ï쳌¯ ï쳌· ï쳌« ï쳌¡ L . ï?? ï?? ï?? ï?? . A guide to designing legal frameworks to de - S ï쳌¨ ï쳌© ï쳌¶ ï쳌¡ V . ï?? ï?? ï?? ï?? . Captive minds , captive lives : Ethics , ecology termine access to genetic resources . Environmental Policy and patents on life . Research Foundation for Science , and Law Paper No . ï?? ï?? . Environmental Law Center , ï쳌© ï쳌µ ï쳌£ ï쳌® , Technology and Natural Resource Policy , India . Gland , Switzerland , Cambridge , ï쳌µ ï쳌« , and Bonn , Germany . S ï쳌¨ ï쳌© ï쳌¶ ï쳌¡ V . ï?? ï?? ï?? ï?? . Biopiracy : The plunder of nature and knowl - G ï쳌¬ ï쳌¯ ï쳌· ï쳌« ï쳌¡ L . , B . P ï쳌© ï쳌³ ï쳌µ ï쳌° ï쳌¡ ï쳌´ ï쳌© , and S . ï쳌¤ ï쳌¥ S ï쳌© ï쳌¬ ï쳌¶ ï쳌¡ . ï?? ï?? ï?? ï?? . Access to ge - edge . South End Press , ï쳌­ ï쳌¡ , ï쳌µ ï쳌³ ï쳌¡ . netic resources and traditional knowledge : Lessons from South and Southeast Asia . ï쳌© ï쳌µ ï쳌£ ï쳌® , Homagama , Sri Lanka . S ï쳌© ï쳌¥ ï쳌¢ ï쳌¥ ï쳌£ ï쳌« W.E . , R.E . E ï쳌¶ ï쳌¥ ï쳌® ï쳌³ ï쳌¯ ï쳌® , W . L ï쳌¥ ï쳌³ ï쳌³ ï쳌¥ ï쳌² , and C.A . P ï쳌² ï쳌© ï쳌­ ï쳌¯ ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ B ï쳌² ï쳌¡ ï쳌§ ï쳌¡ . ï?? ï?? ï?? ï?? . Strengthening protection of intellectual ï쳌´ ï쳌¥ ï쳌® K ï쳌¡ ï쳌´ ï쳌¥ T.K . and S.A . L ï쳌¡ ï쳌© ï쳌² ï쳌¤ . ï?? ï?? ï?? ï?? . The commercial use of biodiversity : Access to genetic resources and benefit - property in developing countries : A Survey of the litera - sharing . Earthscan . London , ï쳌µ ï쳌« . ture . World Bank Discussion Papers No ï?? ï?? ï?? , The World Bank , Washington ï쳌¤ ï쳌£ , ï쳌µ ï쳌³ ï쳌¡ . V ï쳌¯ ï쳌§ ï쳌¥ ï쳌¬ J.H . ï?? ï?? ï?? ï?? . Genes for sale : Privatization as a conserva - tion policy . Oxford University Press , ï쳌® ï쳌¹ , ï쳌µ ï쳌³ ï쳌¡ . S ï쳌© ï쳌­ ï쳌° ï쳌³ ï쳌¯ ï쳌® R.D . , R.A . S ï쳌¥ ï쳌¤ ï쳌ª ï쳌¯ , and J.W R ï쳌¥ ï쳌© ï쳌¤ . ï?? ï?? ï?? ï?? . Valuing bio - diversity for use in pharmaceutical research . Resources ï쳌· ï쳌´ ï쳌¯ News . ï?? ï?? ï?? ï?? . ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ council approves decision on delay - for the Future , Washington , ï쳌¤ ï쳌£ , ï쳌µ ï쳌³ ï쳌¡ . ing pharmaceutical patents for ï쳌¬ ï쳌¤ ï쳌£ s . February ï?? ï?? . http : / / www.wto.org / wto / english / news_e / news ï?? ï?? _e / news ï?? ï?? _ S ï쳌· ï쳌¡ ï쳌® ï쳌³ ï쳌¯ ï쳌® T . ( ed . ) ï?? ï?? ï?? ï?? . Intellectual property rights and biodi - e.htm . versity conservation : An interdisciplinary analysis of the values of medicinal plants . Cambridge University Press , Cambridge , ï쳌µ ï쳌« . Endnotes 1 8 The ï쳌£ ï쳌¢ ï쳌¤ was signed by ï?? ï?? ï?? nations at the United Nations The Andean Community of Nations ( formerly known as the Conference on Environment and Development ( ï쳌µ ï쳌® ï쳌£ ï쳌¥ ï쳌¤ ) in Rio de Andean Pact or Cartagena Accord ) is based on an economic Janeiro , Brazil , ï?? ï?? ï?? ï?? . and social - integration treaty among Colombia , Peru , Ecuador , 2 Venezuela , and Bolivia . ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ is administered by the World Trade Organization ( ï쳌· ï쳌´ ï쳌¯ ) . 9 3 Very restrictive access requirements may have also affected These include the Patent Cooperation Treaty , the Paris Convention communities and industries from other Pacific Rim countries by for the Protection of Industrial Property , and the Bern Convention for the Protection of Literary and Artistic Works . These multilat - excluding them from the benefits derived from biodiversity . In eral treaties are administered by the World Intellectual Property ï?? ï?? ï?? ï?? , the American firm Andes Pharmaceutical applied for access Organization ( ï쳌· ï쳌© ï쳌° ï쳌¯ ) . to Colombiaâ??s genetic resources under Decision ï?? ï?? ï?? , and in ï?? ï?? ï?? ï?? , 4 after two years of negotiations , the application was rejected for See http : / / www.wto.org / wto / english / tratop_e / dda_e / various reasons . One of them was that the benefit - sharing compen - dohaexplained_e.htm for additional details . sation package presented by Andes Pharmaceuticals did not meet 5 In this chapter bioprospecting is defined as the search for plants , the requirements of their counterparts . It should also be noted that animals , and microbial species for academic , pharmaceutical , political motives and the lack of clear negotiation guidelines may biotechnological , agricultural , and other industrial purposes . have also contributed to this decision ( C ï쳌¡ ï쳌² ï쳌² ï쳌© ï쳌º ï쳌¯ ï쳌³ ï쳌¡ ï?? ï?? ï?? ï?? ) . 6 According to C ï쳌¯ ï쳌² ï쳌² ï쳌¥ ï쳌¡ ( ï?? ï?? ï?? ï?? ) genetic engineering has â?? blurred â?쳌 the 10 The workshop was organized by the University of California distinction between â?? inventions â?쳌 that can be patented and â?? discov - Genetic Resources Conservation Program with financial and eries â?쳌 that cannot . An isolated and purified form of a natural prod - technical support provided by the University of California uct can be patented in countries such as the ï쳌µ ï쳌³ ï쳌¡ and Japan . So , â?? the unknown but natural existence of a product cannot preclude the Pacific Rim Research Program , Ford Foundation , The Institute of product from the category of statutory subject matter â?쳌 ( B ï쳌¥ ï쳌® ï쳌´ et al . International Education , Environmental Law Program â?? The World ï?? ï?? ï?? ï?? ) . Also , when patents are granted on genes , they usually cover Conservation Union , Andean Finance Corporation , United Nations the vector or plasmid that incorporates the sequence of the gene University â?? Institute of Advanced Studies . See Appendix ï?? , this and the organism ( i.e . , plant or animal ) that has been transformed volume , for a summary of the workshopâ??s conclusions and see http : by means of the vector ( B ï쳌¡ ï쳌² ï쳌´ ï쳌¯ ï쳌® ï?? ï?? ï?? ï?? ) . / / www.grcp.ucdavis.edu / projects / ï쳌¡ ï쳌¢ ï쳌³ dex.htm for Workshop agenda 8 The Pacific Rim megadiversity countries are China , ï쳌µ ï쳌³ ï쳌¡ , Australia , and roster of participants . Mexico , Indonesia , Peru , Colombia , Papua New Guinea , Malaysia , Philippines , and Ecuador ( M ï쳌© ï쳌´ ï쳌´ ï쳌¥ ï쳌² ï쳌­ ï쳌¥ ï쳌© ï쳌¥ ï쳌² et al . ï?? ï?? ï?? ï?? ) . ï?? 1 Diversity of Policies in Place and in Progress Santiago Carrizosa On ï?? ï?? December ï?? ï?? ï?? ï?? , one and a half years after its sign - Niue , Peopleâ??s Republic of China ( hereafter China ) , Palau , ing , the Convention on Biological Diversity ( ï쳌£ ï쳌¢ ï쳌¤ ) became Panama , Papua New Guinea , Peru , Philippines , Republic international law and a binding legal document for the ï?? ï?? of Korea , Russian Federation , Samoa , Singapore , Solomon countries that ratified it by that date . By October ï?? ï?? ï?? ï?? , Islands , Thailand , Tonga , Tuvalu , the United States of one month before the first meeting of the ï쳌£ ï쳌¢ ï쳌¤ Conference America ( hereafter , ï쳌µ ï쳌³ ï쳌¡ ) , Vanuatu , and Vietnam.As of July of the Parties , ï?? ï?? countries and the European Community ï?? ï?? ï?? ï?? , ï?? ï?? of these countries were Parties to the ï쳌£ ï쳌¢ ï쳌¤ , the ï쳌µ ï쳌³ ï쳌¡ 2 had ratified the convention . Today , there are ï?? ï?? ï?? Parties is a signatory , not a Party . Our findings indicate that only ( countries who have ratified , acceded , accepted , or ap - nine of these ï?? ï?? Pacific Rim countries ( ï?? ï?? % ) had developed 3 proved the ï쳌£ ï쳌¢ ï쳌¤ ) , but only about ï?? ï?? % of these Parties some sort of ï쳌¡ ï쳌¢ ï쳌³ law or policy , ï?? ï?? of them ( ï?? ï?? % ) were have concluded or are developing laws and policies working towards the development of ï쳌¡ ï쳌¢ ï쳌³ frameworks , and six 1 regulating access and benefit sharing ( ï쳌¡ ï쳌¢ ï쳌³ ) . The ï?? ï?? ( ï?? ï?? % ) were not involved in any systematic process leading Pacific Rim countries examined in this report harbor about to the development ï쳌¡ ï쳌¢ ï쳌³ frameworks ( see Table ï?? ) . Before ï?? ï?? % of the worldâ??s biodiversity ( Mittermeier et al . ï?? ï?? ï?? ï?? ) . the ï쳌£ ï쳌¢ ï쳌¤ was signed , most , if not all , of these countries had These countries are : Australia , Cambodia , Canada , Chile , a permit system to regulate the extraction and manage - Colombia , Cook Islands , Costa Rica , Ecuador , El Salvador , ment of biological resources and the transition from these Fiji , Guatemala , Honduras , Japan , Indonesia , Kiribati , Lao permit systems to more comprehensive ï쳌¡ ï쳌¢ ï쳌³ frameworks Peopleâ??s Democratic Republic ( hereafter Laos ) , Malaysia , has proven to be difficult . Chapter ï?? provides a detailed Marshall Islands , Mexico , Federated States of Micronesia account of the problems faced by selected countries during ( hereafter , Micronesia ) , Nauru , New Zealand , Nicaragua , the development process of their ï쳌¡ ï쳌¢ ï쳌³ laws and policies . Overview of Regional and National ABS Policies and Laws Several national and regional initiatives have been under - drafted the â?? ï쳌¡ ï쳌³ ï쳌¥ ï쳌¡ ï쳌® Framework Agreement on Access 6 to Biological and Genetic Resources â?쳌 . However , these taken by Pacific Rim countries to develop ï쳌¡ ï쳌¢ ï쳌³ frameworks . drafts are not as comprehensive , detailed , and prescrip - The presence of common ecoregions ( i.e . , the Andes and tive as Decision ï?? ï?? ï?? . They were developed by each body Amazon ) and ethnic and cultural beliefs were factors knowing that their member countries already had or were that promoted the development of a Common Regime about to develop national ï쳌¡ ï쳌¢ ï쳌³ laws and policies . In contrast , on Access to Genetic Resources ( Decision ï?? ï?? ï?? ) of the 4 the Andean countries had no national ï쳌¡ ï쳌¢ ï쳌³ policies before Andean Community . Following the lead of the Andean Decision ï?? ï?? ï?? was developed . Furthermore , when Decision Community , countries of the Central American region ï?? ï?? ï?? was approved under the Cartagena Agreement of the developed a draft protocol on â?? Access to genetic and Andean Pact Countries it became binding and was auto - biochemical resources , and their associated knowledge â?쳌 5 matically integrated into national legislation . Initially , the and the Association of Southeast Asian Nations ( ï쳌¡ ï쳌³ ï쳌¥ ï쳌¡ ï쳌® ) ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ application by a country of Decision ï?? ï?? ï?? did not require ï쳌¡ ï쳌¢ ï쳌³ provisions and from there they will derive a more the development of any new national law , but only some specific ï쳌¡ ï쳌¢ ï쳌³ framework.As a first step , however , Honduras additional dispositions and regulations might be needed . is developing a proposal to assess national capacity and Venezuela applied this regime directly to several access priorities regarding access to genetic resources . Some 7 applications and Colombia attempted unsuccessfully objectives of this proposal include : a ) identification of to negotiate an access application under Decision ï?? ï?? ï?? . advances in the area of genetic resources ; b ) identification However , technical ambiguities , social protest , political of the importance of genetic resources at a national level ; concerns , and institutional limitations , among other fac - c ) definition of priorities ; and d ) identification of local tors , forced Bolivia , Ecuador , Peru , and recently Colombia organizations that use genetic resources . Honduras has to develop national policies to facilitate the implementa - endorsed the Central American draft protocol on ï쳌¡ ï쳌¢ ï쳌³ and tion of Decision ï?? ï?? ï?? into their national context . Peru , for will likely ratify it once this countryâ??s priorities regarding example , should be approving the regulation of Decision this issue have been identified . Panama will ratify the draft ï?? ï?? ï?? sometime in ï?? ï?? ï?? ï?? ( M . Ruiz , pers . comm . January protocol in ï?? ï?? ï?? ï?? or ï?? ï?? ï?? ï?? and it is currently working on an ï?? ï?? ï?? ï?? ) and Colombia is currently working on a proposal ï쳌¡ ï쳌¢ ï쳌³ policy that will complement existing natural resource for a national ï쳌¡ ï쳌¢ ï쳌³ policy ( see Chapter ï?? ) . Furthermore , use legislation that includes : a ) Forestry Law No . ï?? of ï?? traditional knowledge is part of the scope of protection February ï?? ï?? ï?? ï?? ; b ) Law No . ï?? ï?? of ï?? ï?? December ï?? ï?? ï?? ï?? ; c ) provided by Decision ï?? ï?? ï?? , but the Andean Community Wildlife Law No . ï?? ï?? of ï?? June ï?? ï?? ï?? ï?? ; and d ) Resolution has still to develop a regional policy to address this issue . ï?? ï?? ï?? - ï?? ï?? - ï?? ï?? of January ï?? ï?? ï?? ï?? . The legal mandate to develop On ï?? ï?? August ï?? ï?? ï?? ï?? Peru became the first country in the an ï쳌¡ ï쳌¢ ï쳌³ policy in Panama is included in the ï?? ï?? ï?? ï?? General Andean region that adopted a national comprehensive legal Law of the Environment No . ï?? ï?? ( ï쳌§ ï쳌¬ ï쳌¥ ) that designates the 9 system ( Law No . ï?? ï?? ï?? ï?? ï?? ) for the protection of indigenous National Authority for the Environment ( ï쳌¡ ï쳌® ï쳌¡ ï쳌­ ) as the communities â?? collective knowledge associated with bio - competent authority for the regulation , management , and diversity ( P ï쳌¥ ï쳌² ï쳌µ ï쳌¶ ï쳌© ï쳌¡ ï쳌® C ï쳌¯ ï쳌® ï쳌§ ï쳌² ï쳌¥ ï쳌³ ï쳌³ ï?? ï?? ï?? ï?? ) . On ï?? July ï?? ï?? ï?? ï?? , control of the access to and use of biogenetic resources . the Andean Community adopted a Regional Biodiversity According to ï쳌§ ï쳌¬ ï쳌¥ , ï쳌¡ ï쳌® ï쳌¡ ï쳌­ must elaborate legal instru - Strategy ( Decision ï?? ï?? ï?? ) . This strategy includes an ï쳌¡ ï쳌¢ ï쳌³ ments and economic mechanisms to facilitate ï쳌¡ ï쳌¢ ï쳌³ goals component that describes some of the problems experi - in Panama ( Article ï?? ï?? ) . ï쳌§ ï쳌¬ ï쳌¥ also states that indigenous enced by the Andean countries in implementing Decision communities must have a share of the benefits derived ï?? ï?? ï?? and proposes a course of action to facilitate its imple - from the use of natural resources found in their lands mentation ( A ï쳌® ï쳌¤ ï쳌¥ ï쳌¡ ï쳌® C ï쳌¯ ï쳌­ ï쳌­ ï쳌µ ï쳌® ï쳌© ï쳌´ ï쳌¹ ï?? ï?? ï?? ï?? ) . ( Article ï?? ï?? ï?? ) and clarifies that holders of rights granted The only Pacific Rim country in South America that for the use of natural resources do not hold rights for the does not have any ï쳌¡ ï쳌¢ ï쳌³ policy is Chile . This country has use of genetic resources contained in them ( Article ï?? ï?? ) 8 been the research site of several bioprospecting groups but ( L ï쳌¡ A ï쳌³ ï쳌¡ ï쳌­ ï쳌¢ ï쳌¬ ï쳌¥ ï쳌¡ L ï쳌¥ ï쳌§ ï쳌© ï쳌³ ï쳌¬ ï쳌¡ ï쳌´ ï쳌© ï쳌¶ ï쳌¡ ï?? ï?? ï?? ï?? ) . National initiatives so far this has not been a significant incentive for policy to develop more specific ï쳌¡ ï쳌¢ ï쳌³ regulations include draft makers to develop a comprehensive ï쳌¡ ï쳌¢ ï쳌³ framework . In Law No . ï?? ï?? that might create an Institute on Traditional late ï?? ï?? ï?? ï?? the Ministry of Agriculture developed an ï쳌¡ ï쳌¢ ï쳌³ Indigenous Medicine . This draft law includes some access , proposal that applies only to agricultural genetic resources . benefit - sharing , ï쳌© ï쳌° ï쳌² s , and marketing provisions for prod - The proposal however , was discarded after much criticism , ucts used in traditional indigenous medicine ( see Chapter but efforts to develop a new proposal continue . Also , in ï?? ) . El Salvador just completed ï쳌¡ ï쳌¢ ï쳌³ guidelines that are ï?? ï?? ï?? ï?? the National Commission of the Environment pub - likely to provide a course of action about how to imple - lished the countryâ??s National Biodiversity Strategy that ment existing and future policy . Finally , Guatemalaâ??s ï?? ï?? ï?? ï?? called for the development of an ï쳌¡ ï쳌¢ ï쳌³ policy . The strategy Action Plan of the National Strategy for the Conservation is the guiding chart of the National Biodiversity Action and Sustainable Use of Biodiversity addressed the need Plan that was initiated in mid - ï?? ï?? ï?? ï?? . to develop an ï쳌¡ ï쳌¢ ï쳌³ policy . But policy - makers from this country do not seem to be engaged in a systematic and Costa Rica , one of the main promoters of the Central participatory process to do so . Guatemala is also a signa - American draft protocol on ï쳌¡ ï쳌¢ ï쳌³ , is the only country in tory of the Central American draft protocol on â?? Access to that region that has a national law ( the ï?? ï?? ï?? ï?? Law of genetic and biochemical resources , and their associated Biodiversity No . ï?? ï?? ï?? ï?? ) which includes ï쳌¡ ï쳌¢ ï쳌³ provisions . In knowledge â?쳌 and it will become national law once it is December ï?? ï?? ï?? ï?? , the Costa Rican government published a ratified by this nation . general access procedure that functions as a bylaw of the Law of Biodiversity . Nicaragua has followed the example In North America , Mexico has used Article ï?? ï?? of the ï?? ï?? ï?? ï?? of Costa Rica and developed a proposal for a law of biodi - Ecological Equilibrium and Environmental Protection versity that will be consistent with the protocol and should General Act ( ï쳌¥ ï쳌¥ ï쳌¥ ï쳌° ï쳌§ ï쳌¡ ) to facilitate access for two bio - be sent to Congress in ï?? ï?? ï?? ï?? or ï?? ï?? ï?? ï?? . Nicaraguaâ??s draft prospecting projects ( see Chapters ï?? and ï?? ) . This article law of biodiversity responds to the mandate ( Article ï?? ï?? ) and Article ï?? ï?? ï쳌¢ ï쳌© ï쳌³ were introduced in the ï?? ï?? ï?? ï?? reform of the ï?? ï?? ï?? ï?? General Law of the Environment and Natural of the act and they set forth principles regarding prior Resources No . ï?? ï?? ï?? ( ï쳌§ ï쳌¬ ï쳌¥ ï쳌® ï쳌² ) . Similarly , Honduras is plan - informed consent ( ï쳌° ï쳌© ï쳌£ ) and benefit - sharing issues for col - ning to develop a law of biodiversity that will include lections of biological species for scientific , economic , and ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : D ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¯ ï쳌¦ P ï쳌¯ ï쳌¬ ï쳌© ï쳌£ ï쳌© ï쳌¥ ï쳌³ ï쳌© ï쳌® P ï쳌¬ ï쳌¡ ï쳌£ ï쳌¥ ï쳌¡ ï쳌® ï쳌¤ ï쳌© ï쳌® P ï쳌² ï쳌¯ ï쳌§ ï쳌² ï쳌¥ ï쳌³ ï쳌³ biotechnology purposes . The ï?? ï?? ï?? ï?? Wildlife General Act are consistent with , the WildlifeAct . Even though Thailand did not become a ï쳌£ ï쳌¢ ï쳌¤ Party until January ï?? ï?? ï?? ï?? , in ï?? ï?? ï?? ï?? , ( ï쳌· ï쳌§ ï쳌¡ ) and the ï?? ï?? ï?? ï?? Sustainable Forestry Development this country adopted the following laws and regulations General Act ( ï쳌³ ï쳌¦ ï쳌¤ ï쳌§ ï쳌¡ ) regulate the collection of wildlife that cover ï쳌¡ ï쳌¢ ï쳌³ issues and apply to bioprospectors : a ) the resources and forest biological resources respectively and Royal Forest Department ( ï쳌² ï쳌¦ ï쳌¤ ) Regulation on Forestry address ï쳌° ï쳌© ï쳌£ and benefit - sharing issues as well . However , Studying and Research Conducting within Forested Areas ï쳌¥ ï쳌¥ ï쳌¥ ï쳌° ï쳌§ ï쳌¡ , ï쳌· ï쳌§ ï쳌¡ , and ï쳌³ ï쳌¦ ï쳌¤ ï쳌§ ï쳌¡ lack details about how to achieve ( ï쳌² ï쳌¦ ï쳌³ ï쳌² ï쳌£ ï쳌¦ ï쳌¡ ) ; b ) the Plant Variety Protection Act ( ï쳌° ï쳌¶ ï쳌° ï쳌¡ ) ; the implementation of ï쳌° ï쳌© ï쳌£ requirements and other ï쳌¡ ï쳌¢ ï쳌³ and c ) Act on Protection and Promotion of Traditional principles . Currently , there are two pieces of legislation Medicinal Intelligence ( ï쳌¡ ï쳌° ï쳌° ï쳌´ ï쳌­ ï쳌© ) . In addition , foreign in Congress that purport to fill this gap . One submitted bioprospectors have to comply with the regulation on the by the Federal Representative Alejandro Cruz Gutierrez permission for foreign researchers to conduct research ( Institutional Revolutionary Party ) and the other by Federal in Thailand that was enacted by the National Research Senator Jorge Nordhausen ( National Action Party ) . The Council of Thailand ( ï쳌® ï쳌² ï쳌£ ï쳌´ ) in ï?? ï?? ï?? ï?? . These policies , how - proposal of Senator Nordhausen , entitled â?? Law forAccess ever , present overlapping problems . Therefore , in ï?? ï?? ï?? ï?? and Use of Biological and Genetic Resources â?쳌 ( ï쳌¬ ï쳌¡ ï쳌µ ï쳌¢ ï쳌§ ï쳌² ) , the Prime Minister enacted a regulation on Conservation is more comprehensive and may be approved sometime in and Utilization of Biological Resources that is basically a ï?? ï?? ï?? ï?? or ï?? ï?? ï?? ï?? ( Jorge Larson , pers . comm . February ï?? ï?? ï?? ï?? ) . mandate for all government bodies to coordinate the devel - Therefore , it will be discussed in this report . Canada has opment and implementation of ï쳌¡ ï쳌¢ ï쳌³ rules and procedures , undertaken some background research on ï쳌¡ ï쳌¢ ï쳌³ issues and among other issues . held some preliminary discussions with provincial govern - In Malaysia , the federal government is currently fi - ments and some aboriginal groups . The ï쳌µ ï쳌³ ï쳌¡ is not a ï쳌£ ï쳌¢ ï쳌¤ nalizing a bill on ï쳌¡ ï쳌¢ ï쳌³ that could be enacted in ï?? ï?? ï?? ï?? or Party and it does not have a national ï쳌¡ ï쳌¢ ï쳌³ policy . Access is ï?? ï?? ï?? ï?? . This bill will complement ï쳌¡ ï쳌¢ ï쳌³ policies already usually regulated by the landowner . Multiple federal and state enacted at a state level by Sarawak and Sabah . Singapore laws regulate genetic resources found on land owned by the is also developing a national ï쳌¡ ï쳌¢ ï쳌³ policy and guidelines . federal or state governments . In contrast , genetic resources Indonesia is currently working on an Act on Genetic found on private lands are controlled by the owner unless Resource Management that includes a government regu - these resources are protected by the Endangered SpeciesAct lation on ï쳌¡ ï쳌¢ ï쳌³ issues . In Cambodia , ï쳌¡ ï쳌¢ ï쳌³ issues are partially or other relevant federal or state laws . The owner of genetic regulated by the ï?? ï?? ï?? ï?? Forestry Law . Laos , however , is resources is relatively free to negotiate ï쳌¡ ï쳌¢ ï쳌³ conditions with not currently engaged in the development of national ï쳌¡ ï쳌¢ ï쳌³ the bioprospector . frameworks . On the other hand Vietnamâ??s ï?? ï?? ï?? ï?? National The only European country that borders the Pacific Rim Action Plan on Biological Diversity addressed the need is the Russian Federation and , despite its high biological to develop an ï쳌¡ ï쳌¢ ï쳌³ policy . Therefore , in the last few years diversity , this country has not developed a comprehensive the government has been collecting and analyzing ï쳌¡ ï쳌¢ ï쳌³ ï쳌¡ ï쳌¢ ï쳌³ framework . The Ministry of Industry , Science , and literature and it is planning to start working actively on Technology is analyzing ï쳌¡ ï쳌¢ ï쳌³ issues such as ownership of a national ï쳌¡ ï쳌¢ ï쳌³ policy in ï?? ï?? ï?? ï?? or ï?? ï?? ï?? ï?? . The two Asian genetic resources in the context of existing legislation . economic powers , China and Japan , also lack ï쳌¡ ï쳌¢ ï쳌³ policies These issues have been addressed thanks to the momen - but both countries are collecting information , conducting tum created by a ï?? ï?? ï?? ï?? national report on access to genetic studies , and analyzing trends regarding ï쳌¡ ï쳌¢ ï쳌³ policies . The resources . Environmental Protection Administration of China is also In the Asian region of the Pacific Rim , the Philippines putting together a team to develop a comprehensive ï쳌¡ ï쳌¢ ï쳌³ and Thailand are the only two countries that have com - law or policy . The Republic of Korea is currently amend - pleted national ï쳌¡ ï쳌¢ ï쳌³ frameworks . In ï?? ï?? ï?? ï?? , the Philippines ing its ï?? ï?? ï?? ï?? Natural Environment Conservation Act . The enacted Republic Act No . ï?? ï?? ï?? ï?? , known as the Wildlife amended act will include specific ï쳌¡ ï쳌¢ ï쳌³ provisions and it is Resources and Conservation Act ( hereafter Wildlife Act ) likely to be completed in ï?? ï?? ï?? ï?? or ï?? ï?? ï?? ï?? . It should be noted that addressed many of the criticisms of an earlier policy , that this act has been repeatedly amended since ï?? ï?? ï?? ï?? . For the ï?? ï?? ï?? ï?? Executive Order No . ï?? ï?? ï?? ( ï쳌¥ ï쳌¯ ï?? ï?? ï?? ) . The Wildlife example , the ï?? ï?? ï?? ï?? amendment included Article ï?? ï?? . ï?? that Act is a codification of existing laws on the protection allowed foreigners to collect and use domestic biological and conservation of wildlife resources . It includes only resources for commercial , medical , or scientific uses . This two provisions that deal with bioprospecting issues but it article , however , was removed from the act by Law No . modifies ï쳌¥ ï쳌¯ ï?? ï?? ï?? considerably and facilitates access to the ï?? ï?? ï?? ï?? of ï?? February ï?? ï?? ï?? ï?? . countryâ??s genetic resources . In July ï?? ï?? ï?? ï?? , draft â?? Guidelines In addition to these national ï쳌¡ ï쳌¢ ï쳌³ policies , severalAsian 10 for Bioprospecting Activities in the Philippines â?쳌 was re - nations have been active in the development of a regional leased for review and comment . These guidelines outline policy known as the ï쳌¡ ï쳌³ ï쳌¥ ï쳌¡ ï쳌® Framework Agreement on detailed ï쳌¡ ï쳌¢ ï쳌³ requirements for commercial bioprospectors Access to Biological and Genetic Resources , scheduled and facilitate the implementation of the Wildlife Act . The to be adopted in ï?? ï?? ï?? ï?? or ï?? ï?? ï?? ï?? by the ï쳌¡ ï쳌³ ï쳌¥ ï쳌¡ ï쳌® countries . guidelines would also facilitate the implementation of The ï쳌¡ ï쳌³ ï쳌¥ ï쳌¡ ï쳌® framework will cover the following Pacific those provisions of ï쳌¥ ï쳌¯ ï?? ï?? ï?? that were not repealed by , or Rim countries whose ï쳌¡ ï쳌¢ ï쳌³ frameworks are analyzed in this ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ report : Thailand , Malaysia , Singapore , Indonesia , Laos , was presented to the tribunals in ï?? ï?? ï?? ï?? and is not likely to be settled in the near future . Nevertheless , government and Cambodia . officials continue to debate bioprospecting issues together In Oceania , Australia has carried out an interesting process with this community and other stakeholders . In Samoa , in that resulted in the development of the ï?? ï?? ï?? ï?? Environment ï?? ï?? ï?? ï?? , the Department of Lands , Surveys , and Environment Protection and Biodiversity Conservation Amendment adopted a preliminary regulation titled â?? Conditions for Regulations ( ï쳌¥ ï쳌° ï쳌¢ ï쳌£ ï쳌¡ ï쳌² ) that will apply to ï쳌¡ ï쳌¢ ï쳌³ issues in Access to and Benefit Sharing of Samoaâ??s Biodiversity the commonwealth areas of Australia . These regulations , Resources â?쳌 ( ï쳌£ ï쳌¡ ï쳌¢ ï쳌³ ï쳌³ ï쳌¢ ï쳌² ) . In addition , this department is which will reform the ï?? ï?? ï?? ï?? Environment Protection and working on a more comprehensive ï쳌¡ ï쳌¢ ï쳌³ regulation that will Biodiversity Conservation Act , are likely to be introduced be appended to the ï?? ï?? ï?? ï?? Lands and Environment Act that in Parliament in ï?? ï?? ï?? ï?? . At a state level , Queensland and is currently under revision . In March ï?? ï?? ï?? ï?? , Micronesia fin - WesternAustralia are also undertaking activities to develop ished its National Biodiversity Strategy and it is expected ï쳌¡ ï쳌¢ ï쳌³ laws . In mid - ï?? ï?? ï?? ï?? , Queensland adopted a Biodiscovery that the development of ï쳌¡ ï쳌¢ ï쳌³ policy will follow from the Bill and Western Australia is currently discussing a licens - needs identified by the strategy . ing regime for terrestrial bioprospecting activities that will Cook Islands , Fiji , Marshall Islands , Niue , Solomon be included in a draft Biodiversity ConservationAct . These Islands , and Vanuatu lack ï쳌¡ ï쳌¢ ï쳌³ policies but have working states are consulting with EnvironmentAustralia to ensure groups and committees in place analyzing existing leg - that where jurisdictions overlap with commonwealth ter - islation and proposing courses of action for the develop - ritories , these regulations are not duplicated . In addition to ment of local policies . Vanuatu , for example , is analyzing this , in ï?? ï?? ï?? ï?? the Natural Resource Management Ministerial ï쳌¡ ï쳌¢ ï쳌³ provisions that might be included in the draft of its Council adopted a federal agreement on a â?? Nationally Environment Act . Palau is planning to start working on Consistent Approach for Access to and the Utilization of ï쳌¡ ï쳌¢ ï쳌³ policies sometime between ï?? ï?? ï?? ï?? and ï?? ï?? ï?? ï?? , depending Australiaâ??s Native Genetic and Biochemical Resources â?쳌 . on the availability of funding and technical capacity . In This agreement includes ï?? ï?? principles to facilitate the Papua New Guinea , the Department of Environment and development or review of legislative , administrative , or Conservation is working closely with lawyers from the policy ï쳌¡ ï쳌¢ ï쳌³ initiatives for a nationally consistent approach Department of Justice and Attorney General to develop in each jurisdiction . a framework on intellectual property rights and ï쳌¡ ï쳌¢ ï쳌³ . Australiaâ??s neighbor , New Zealand , has undertaken Kiribati , Nauru , Tonga , and Tuvalu have received techni - some key activities towards the development of a national cal advice from the South Pacific Regional Environment ï쳌¡ ï쳌¢ ï쳌³ policy . In November ï?? ï?? ï?? ï?? , the Ministry of Economic Program , ï쳌· ï쳌· ï쳌¦ - South Pacific Program , the Foundation for Development published a discussion paper on bioprospect - International Environmental Law and Development , and ing . The paper invited the public to submit comments by other local organizations , but these countries are not cur - the end of February ï?? ï?? ï?? ï?? . In May ï?? ï?? ï?? ï?? the Ministry posted rently engaged in a systematic development process of ï쳌¡ ï쳌¢ ï쳌³ 11 a summary of the submissions on its website . However , policies . The ï쳌¡ ï쳌¢ ï쳌³ laws and policies of these countries are future efforts to develop ï쳌¡ ï쳌¢ ï쳌³ legislation can be compli - in different stages of development and implementation and all of them provide valuable lessons . Table ï?? summarizes cated by a claim by a number of tribes ( Iwi ) of the Maori the information provided in the preceding paragraphs and people to a tribunal in which they assert exclusive rights provides additional details . over both traditional knowledge and indigenous genetic resources under the Waitangi Treaty of ï?? ï?? ï?? ï?? . This claim Analyzing ABS Policies and Laws of Selected Countries The remainder of this chapter focuses on national ï쳌¡ ï쳌¢ ï쳌³ regulations that bioprospectors have to follow in order policies and laws that are already in place and drafts of to access genetic resources . This section examines the ï쳌¡ ï쳌¢ ï쳌³ policies and laws that are still going through an ex - application of National Park Service ( ï쳌® ï쳌° ï쳌³ ) regulations to ecutive or legislative process and may still be modified . ï쳌¡ ï쳌¢ ï쳌³ activity ( i.e . , the Diversa / Yellowstone National Park These drafts include interesting provisions that merit bioprospecting project ) and it suggests that these regula - careful analysis and are useful for the purposes of this tions are analogous to ï쳌¡ ï쳌¢ ï쳌³ laws and policies developed by report . Colombia , Costa Rica , Ecuador , Mexico , Peru , other countries under the umbrella of the ï쳌£ ï쳌¢ ï쳌¤ . Philippines , Samoa , and Thailand comprise the group Australia , Malaysia , and Nicaragua comprise the group that has already adopted national ï쳌¡ ï쳌¢ ï쳌³ laws and policies . that is in the process of developing or adopting ï쳌¡ ï쳌¢ ï쳌³ poli - Despite the fact that they may still be modified at a politi - cies or laws . Australiaâ??s amendment regulations on access cal and legislative level , these laws and policies can be to genetic resources are likely to be passed by Parliament used by bioprospectors . As noted above , the ï쳌µ ï쳌³ ï쳌¡ does not in ï?? ï?? ï?? ï?? or ï?? ï?? ï?? ï?? and Malaysiaâ??s federal bill on access to have a national ï쳌¡ ï쳌¢ ï쳌³ policy and it is not likely to develop genetic resources is likely to be approved by Parliament one in the future . However , depending on the region where in ï?? ï?? ï?? ï?? . Nicaraguaâ??s Ministry for the Environment and biological or genetic resources are found , there are certain Natural Resources recently concluded a final draft of the ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : D ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¯ ï쳌¦ P ï쳌¯ ï쳌¬ ï쳌© ï쳌£ ï쳌© ï쳌¥ ï쳌³ ï쳌© ï쳌® P ï쳌¬ ï쳌¡ ï쳌£ ï쳌¥ ï쳌¡ ï쳌® ï쳌¤ ï쳌© ï쳌® P ï쳌² ï쳌¯ ï쳌§ ï쳌² ï쳌¥ ï쳌³ ï쳌³ Law of Biodiversity and it should be sent to Congress in Therefore , these resources belong to the State and it can ï?? ï?? ï?? ï?? or ï?? ï?? ï?? ï?? . regulate access to them ( see Chapter ï?? ) . This section discusses the main provisions of ï쳌¡ ï쳌¢ ï쳌³ Malaysia : laws and policies of these nations that have been inspired Draft federal bill on access to genetic resources by the ï쳌£ ï쳌¢ ï쳌¤ and influenced by international and national In Malaysia , ownership of biological , genetic , and bio - social , economic , and political factors . These provisions chemical resources is still a gray area . The Constitution are : a ) ownership ; b ) scope ; c ) access procedure ; d ) prior allocates ownership of land and minerals to the thirteen informed consent ; e ) benefit sharing and compensation states . Therefore , biological , biochemical , and genetic mechanisms ; f ) intellectual property rights and the pro - resources found in public lands belong to the individual tection of traditional knowledge ; g ) in situ biodiversity state . However , in some states the ownership situation of conservation and sustainable use ; and h ) enforcement resources found in indigenous and private land is under and monitoring . Each of these issues will be presented as controversy and it is unclear whether these resources be - national laws and policies describe them . Then , a subse - long to the state or the owner of the land ( see Chapter ï?? ï?? ) . quent analysis will compare and contrast the main issues The draft of the federal bill on access to genetic resources and implications for the main actors that play a part in will apply to public , indigenous , and private lands , there - bioprospecting initiatives , namely government authorities , fore ownership of resources found in these areas will have bioprospectors , and the providers of genetic resources and to be clarified before the law is adopted . traditional knowledge . Mexico : EEEPGA , WGA , SFDGA , and draft LAUBGR Ownership In Mexico , ï쳌¥ ï쳌¥ ï쳌¥ ï쳌° ï쳌§ ï쳌¡ has been implemented to regulate ï쳌¡ ï쳌¢ ï쳌³ under the understanding that genetic resources are public Ownership of genetic resources determines access condi - property . The Constitution defines public property over tions , procedures , rules , and rights over these resources . certain natural resources , such as land , oil , and water . It Traditionally , the constitutions of countries define the does not mention genetic resources , but again as in other concept of ownership of natural resources . The concept constitutions it can be implied that natural resources con - of ownership of genetic resources is novel and in some tain the biological , biochemical , and genetic components . cases ï쳌¡ ï쳌¢ ï쳌³ laws have made the connection between natural In addition to this , ï쳌· ï쳌§ ï쳌¡ recognizes the rights of landowners and genetic resources . This section compares and contrasts to make a sustainable use of the wildlife resources found ownership systems of natural and genetic resources pro - in their lands ( ï쳌³ ï쳌¥ ï쳌­ ï쳌¡ ï쳌² ï쳌® ï쳌¡ ï쳌´ ï?? ï?? ï?? ï?? ) and ï쳌³ ï쳌¦ ï쳌¤ ï쳌§ ï쳌¡ establishes that posed by the selected countries . the owners of forest resources are the owners of the land where these resources are found ( ï쳌³ ï쳌¥ ï쳌­ ï쳌¡ ï쳌² ï쳌® ï쳌¡ ï쳌´ ï?? ï?? ï?? ï?? ) . Critics , Australia : Draft EPBCAR however , argue that new legislation has to be developed to In the commonwealth areas of Australia , the Common - clarify public , indigenous , and private property status of wealth owns the biological resources in the land in accor - genetic and biochemical resources ( see Chapter ï?? ) . The dance with common law principles discussed byV ï쳌¯ ï쳌µ ï쳌­ ï쳌¡ ï쳌² ï쳌¤ draft ï쳌¬ ï쳌¡ ï쳌µ ï쳌¢ ï쳌§ ï쳌² may help clarify the ownership status of ( ï?? ï?? ï?? ï?? ) . The Australian Constitution , however , does not genetic resources ( G ï쳌¡ ï쳌£ ï쳌¥ ï쳌´ ï쳌¡ P ï쳌¡ ï쳌² ï쳌¬ ï쳌¡ ï쳌­ ï쳌¥ ï쳌® ï쳌´ ï쳌¡ ï쳌² ï쳌© ï쳌¡ ï?? ï?? ï?? ï?? ) . explicitly provide for this . Rather , ownership flows from the common law . This provides that ownership of land Nicaragua : Draft Law of Biodiversity includes the substrata . That being the case , natural things In ï?? ï?? ï?? ï?? , ï쳌§ ï쳌¬ ï쳌¥ ï쳌® ï쳌² established that natural resources are growing on it or in it are owned by the Commonwealth . patrimony of the state ( ï쳌­ ï쳌¡ ï쳌² ï쳌¥ ï쳌® ï쳌¡ ï?? ï?? ï?? ï?? ) . The draft Law of Insofar as genetic and biochemical resources are physical Biodiversity takes a step forward by specifying that that elements found within biological resources then , where wildlife , genetic , and biochemical resources are considered the Commonwealth owns the biological resources , then public domain . Therefore , these resources belong to the 12 it must also own those constituent elements ( G . Burton , State which can regulate access to them . Nevertheless , it pers . comm . January ï?? ï?? ï?? ï?? ) . is important to note that the draft law acknowledges that indigenous peoples own the wildlife , biochemical , and Colombia , Ecuador , and Peru : Decision 391 genetic resources found in their territories . This , however , Decision ï?? ï?? ï?? establishes that genetic resources and their does not mean that they can access these resources for derivatives found in theAndean Community are considered biotechnological purposes without State intervention . the goods or patrimony of the State , depending on the The State is still a party in any agreement established countryâ??s national legislation . This applies to resources between an indigenous community and a third party found in private , public , and indigenous lands and in in situ ( ï쳌­ ï쳌¡ ï쳌² ï쳌¥ ï쳌® ï쳌¡ ï?? ï?? ï?? ï?? ) . and ex situ conditions ( A ï쳌® ï쳌¤ ï쳌¥ ï쳌¡ ï쳌® C ï쳌¯ ï쳌­ ï쳌­ ï쳌µ ï쳌® ï쳌© ï쳌´ ï쳌¹ ï?? ï?? ï?? ï?? ) . Philippines : EO 247 and Wildlife Act Costa Rica : The Law of Biodiversity The Constitution states that all lands of the public domain , This law states that genetic and biochemical resources waters , minerals , coal , petroleum , and other mineral oils , are considered to be in the public domain , independent of any private ownership of the land where they are located . all forces of potential energy , fisheries , forests or timber , ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ wildlife , flora and fauna , and other natural resources are legal status of their genetic ( and biochemical ) resources . For example , wild fauna found in in situ conditions has owned by the State . The exploration , development , and been considered res nullius , or no oneâ??s property . This utilization of natural resources shall be under the full concept has been replaced by that of Stateâ??s ownership control and supervision of the State . This provision of which means that the State would have to authorize the the Constitution is the basis for ï쳌¥ ï쳌¯ ï?? ï?? ï?? as stated in its use by others of this resource ( ï쳌¤ ï쳌¥ K ï쳌¬ ï쳌¥ ï쳌­ ï쳌­ ï?? ï?? ï?? ï?? ) . Plants Preamble . Although it is not categorically stated in ï쳌¥ ï쳌¯ ï?? ï?? ï?? can be considered as State , private , or communal prop - that ownership of biological and genetic resources belongs erty . In theory , the private owner and the co - owners have to the State , it is implied in some of its provisions such as the discretion to use their resources the way they see fit . the collection of royalties for the use of these resources . However , private and communal property of plants and Furthermore , the claim of State ownership over these re - other biological resources can be subject to government sources is expressly stated in commercial and academic restrictions ( G ï쳌¬ ï쳌¯ ï쳌· ï쳌« ï쳌¡ ï?? ï?? ï?? ï?? ) . research agreements that have been subsequently devel - Two ownership systems can be identified from the oped . Therefore , it is reasonable to assume that when the case studies . In one system , priority is given to private or Constitution says â?? natural resources â?쳌 , the term includes communal ownership of natural resources and the private all that is part or portion of the resource ( tissues , genes , or communal owner of the land does not need the Stateâ??s molecules , etc ) , plant or animal , living or preserved . Thus , approval to market his or her biological , biochemical , or exploration and use of these resources is under the full genetic resources . Nevertheless , there may be restrictions control and supervision of the State ( P . Benavidez , pers . to this system if the target species is protected by special comm . January ï?? ï?? ï?? ï?? ) . legislation such as the Endangered Species Act in the Samoa : CABSSBR ï쳌µ ï쳌³ ï쳌¡ . A second system considers natural resources ( and Samoaâ??s Constitution is not specific about ownership of the biological , biochemical , and genetic components ) natural , biological , or genetic resources.Also , the ï쳌£ ï쳌¡ ï쳌¢ ï쳌³ ï쳌³ ï쳌¢ ï쳌² as property of the State . The main implication of such a does not include information about ownership of these re - regime is that access to these resources is regulated for public , communal , and private lands . Therefore , biopros - sources ( ï쳌¤ ï쳌¬ ï쳌³ ï쳌¥ ï?? ï?? ï?? ï?? ) . Land is classified as private , freehold , 13 pectors are required to have a permit from the State and and customary land ( the latter amounting to about ï?? ï?? % the individual or collective owner or holder of the land of the countryâ??s total land area ) ( C . Peteru , pers . comm . or collection where the biological or genetic resource is December ï?? ï?? ï?? ï?? ) . found . Under either of these two systems , the State and the Thailand : PVPA , RFSRCFA , and APPTMI owner of the land have veto powers and may deny access The Constitution states that natural resources are owned to their resources . by the State but it gives the authority to manage such resources to the people . Therefore , if natural , biological , Scope and genetic resources are found in National Forests or any A precise definition of the scope of ï쳌¡ ï쳌¢ ï쳌³ policies and laws other public land , the owner is the State . If these resources facilitates their implementation . The concept of scope are found in a private garden , the landowner will need the should address several questions about the types of ge - Stateâ??s authorization to commercialize them . In any case , netic and biological resources covered by a given policy ownership issues is still a gray area in Thailand and the or law : Are they found in in situ or ex situ conditions or government is trying to develop laws such as the ï쳌° ï쳌¶ ï쳌° ï쳌¡ both ? Does the policy apply to derivatives ? Does it cover to clarify ownership issues regarding biological , genetic , the traditional or scientific knowledge associated with the and biochemical resources ( J . Donavanik , pers . comm . biological resources ? Does it address the use of human January ï?? ï?? ï?? ï?? ) . genetic resources and the use and exchange of biological USA : NPS research specimen collection permit resources by indigenous communities ? The scope should Title ï?? ï?? of the ï쳌µ ï쳌³ Code of Federal Regulation states that all also include information about the geographic boundar - specimens collected in a national park under research ( or ies , context , and coverage of access activities and it may access ) permits belong to that park . This is the case of the also identify access restrictions such as geographic sites , collection of samples carried out by Diversa inYellowstone genetic and biological material , and actors that can use National Park ( see Chapter ï?? ) . and mobilize biological material without having to apply for access . Analysis : Ownership The legal status of genetic resources depends on the rights Australia : Draft EPBCAR upon an organism or its parts , and the information em - These regulations will apply to Commonwealth areas which bodied in them . Evidently , the information component of are lands owned or leased by the Commonwealth govern - genetic resources is the most valuable for bioprospectors . ment and marine areas over which the Commonwealth has However , no State has created a property right system sovereignty . The regulations will not apply to the states for this component . Therefore , countries still rely on the and territories , which have their own legislation and poli - physical entity ( i.e . , organism or its parts ) to define the cies governing access to biological resources . However , ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : D ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¯ ï쳌¦ P ï쳌¯ ï쳌¬ ï쳌© ï쳌£ ï쳌© ï쳌¥ ï쳌³ ï쳌© ï쳌® P ï쳌¬ ï쳌¡ ï쳌£ ï쳌¥ ï쳌¡ ï쳌® ï쳌¤ ï쳌© ï쳌® P ï쳌² ï쳌¯ ï쳌§ ï쳌² ï쳌¥ ï쳌³ ï쳌³ in October ï?? ï?? ï?? ï?? , the Natural Resource Management defined as accumulated and transgenerational knowledge developed by indigenous communities about properties , Ministerial Council proposed fourteen principles to pro - uses , and characteristics of biological diversity ( P ï쳌¥ ï쳌² ï쳌µ ï쳌¶ ï쳌© ï쳌¡ ï쳌® mote the development or review of legislative , adminis - C ï쳌¯ ï쳌® ï쳌§ ï쳌² ï쳌¥ ï쳌³ ï쳌³ ï?? ï?? ï?? ï?? ) . The scope does not apply to agricultural trative , or policy frameworks for a nationally consistent or marine practices or innovations . It is also limited to col - approach for the Commonwealth , states , and territories lective knowledge of the community and does not extend ( see Chapter ï?? ) . to the knowledge of individuals inside the community . The The regulations also apply to the collection and use scope also poses practical difficulties that include defining of native biological resources , genetic resources , and guidelines to identify collective knowledge that applies to biochemical compounds for commercial , scientific , and biological diversity and the boundaries of the community conservation purposes . The scope also covers traditional or communities that hold such knowledge . knowledge associated with the use of these resources but it excludes human genetic resources and the use and ex - Costa Rica : The Law of Biodiversity change of biological resources by indigenous communities . This law regulates the use , management , associated The regulations will apply only to native species and not knowledge , and the equitable distribution of benefits and to exotic plants and animals . The regulations are not clear costs derived from the utilization of all in situ and ex situ regarding application to genetic resources found in ex situ biological and genetic resources ( native and domestic ) . conditions . Under the regulations , permit provisions may The scope also extends to biochemical resources which are not apply to biological resources in the following cases : defined as any material derived from plants , animals , fungi , a ) if they are found in a collection of a Commonwealth or microorganisms that contains specific characteristics department or agency and if there are reasonable grounds or special molecules or leads to the design of them . The to believe that access to the biological resources is ad - law excludes access to human genetic and biochemical ministered consistently with the purpose of the regula - resources and the exchange of genetic and biochemical tions ; b ) if access to these resources is controlled by resources that are part of traditional practices of indigenous another Commonwealth , self - governing territory , or state peoples and local communities ( see Chapter ï?? ) . law , consistent with the purpose of the regulations ( the purpose of this provision is to avoid duplication of any Malaysia : access arrangements applying in a Commonwealth area ) ; Draft federal bill on access to genetic resources and c ) if an international agreement , to which Australia The draft law will regulate access to in situ and ex situ is a Party , applies ( e.g . , ï쳌¦ ï쳌¡ ï쳌¯ International Treaty on Plant biological and genetic resources and their derivatives and Genetic Resources for Food and Agriculture ( ï쳌© ï쳌´ ï쳌° ï쳌§ ï쳌² ï쳌¦ ï쳌¡ ) ) associated knowledge . These include native and domestic ( see Chapter ï?? ) . resources used by all industries and academia for com - mercial and noncommercial purposes . With respect to ex Colombia , Ecuador , and Peru : Decision 391 situ resources , the draft would apply only to those acquired Decision ï?? ï?? ï?? applies to all in situ and ex situ genetic after the ï쳌£ ï쳌¢ ï쳌¤ entered into force . resources ( native and domestic ) and their derivatives in - Access to genetic resources will be limited to the digenous to each member country and to genetic resources biological and geographical boundaries as defined by of migratory species that are collected in any of these coun - the federal government . These include genetic resources tries for bioprospecting , basic research , conservation , in - found on public lands , communal or customary lands , dustrial , and commercial purposes . Derivatives are defined and private lands . The draft legislation also preserves the as molecules , a combination or mix of natural molecules , rights of indigenous and local communities to continue including crude extracts of living or dead organisms of with their traditional customary practices of use , exchange , biological origin , coming from the metabolism of living and marketing of biological resources . As an exemption , beings.Access may also be limited in cases of : a ) presence access to human genetic resources is prohibited by the of endangered , rare , or endemic species , subspecies , or draft legislation . It is not clear what will be the relationship races and b ) fragile or vulnerable ecosystems . The scope between the scope of this law and that of access policies of Decision ï?? ï?? ï?? excludes all human genetic resources and enacted by the Malaysian states of Sabah and Sarawak their derivatives and the consumption and exchange of ( see Chapter ï?? ï?? ) . all genetic resources , their derivatives , associated knowl - edge , and biological resources among black , indigenous , Mexico : EEEPGA , WGA , SFDGA , and draft LAUBGR and local communities ( A ï쳌® ï쳌¤ ï쳌¥ ï쳌¡ ï쳌® C ï쳌¯ ï쳌­ ï쳌­ ï쳌µ ï쳌® ï쳌© ï쳌´ ï쳌¹ ï?? ï?? ï?? ï?? ) . ï쳌¥ ï쳌¥ ï쳌¥ ï쳌° ï쳌§ ï쳌¡ regulates access to native plant and animal spe - The scope also applies to the collective and individual cies and other biological resources for scientific ( noncom - knowledge , innovation , or practice involving a species or mercial ) , economic ( for reproduction and commercial its derivatives . objectives ) , and biotechnological ( commercial ) purposes . The scope of Peruâ??s new Law No . ï?? ï?? ï?? ï?? ï?? on the protec - Biotechnology is defined as any application that uses bio - tion of knowledge of indigenous peoples applies only to logical resources , living organisms , or their derivatives for the collective knowledge of indigenous communities about the creation or modification of products for specific uses uses and properties of biodiversity . Collective knowledge is ( see Chapter ï?? ) . The ï쳌¥ ï쳌¥ ï쳌¥ ï쳌° ï쳌§ ï쳌¡ does not cover traditional ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ knowledge associated with the species nor access to ex Philippines : EO 247 and Wildlife Act ï쳌¥ ï쳌¯ ï?? ï?? ï?? regulates access to wild biological and genetic situ genetic resources . resources and their by - products and derivatives used for The scope of ï쳌· ï쳌§ ï쳌¡ includes the scientific , academic , commercial and noncommercial purposes . By - products are or noncommercial collection of wild flora and fauna , their defined as any part taken from wild biological resources parts and derivatives , excluding aquatic and domestic spe - such as hides , antlers , feathers , fur , internal organs , roots , cies and traditional knowledge . ï쳌· ï쳌§ ï쳌¡ does not regulate trunks , branches , leaves , stems , flowers , and the like , in - ex situ collections directly . However , any scientific and cluding compounds indirectly produced in a biochemical museum collection of wildlife species , whether private process or cycle . Derivatives refer to something extracted or public , must be registered and permanently updated from wild biological resources such as blood , oils , resins , in an official record . Once registered , this collection can genes , seeds , spores , pollen , and the like , taken from or be exempted , under specific circumstances , from certain modified from a product . Genetic resources are defined as obligations regulating proof of legal provenance of wildlife genetic material of actual or potential value and genetic species as long as they do not have any biotechnological or material means any material of plant , animal , microbial commercial purposes ( ï쳌³ ï쳌¥ ï쳌­ ï쳌¡ ï쳌² ï쳌® ï쳌¡ ï쳌´ ï?? ï?? ï?? ï?? ) . ï쳌³ ï쳌¦ ï쳌¤ ï쳌§ ï쳌¡ regulates or other origin containing functional units of heredity . the collection and use of forest biological resources for Access is regulated in the public domain and in the cases scientific , economic , and biotechnological purposes . Forest of natural occurrence in private or communal lands . ï쳌¥ ï쳌¯ biological resources are defined as species and varieties of ï?? ï?? ï?? also recognizes the rights of indigenous communities plants , animals , and microorganisms and their biodiversity to their knowledge when it is used for commercial pur - found in forest ecosystems . ï쳌³ ï쳌¦ ï쳌¤ ï쳌§ ï쳌¡ states that commercial poses , but this policy does not apply to traditional uses of or noncommercial collectors of forest biological resources biological and genetic resources by indigenous and local must acknowledge the rights of indigenous peoples on the communities in accordance with their traditional practices ownership , knowledge , and use of local varieties ( ï쳌³ ï쳌¥ ï쳌­ ï쳌¡ ï쳌² - ( see Chapter ï?? ) . ï쳌® ï쳌¡ ï쳌´ ï?? ï?? ï?? ï?? ) . The law , however , does not define the concept Under ï쳌¥ ï쳌¯ ï?? ï?? ï?? bioprospecting was defined as the of local varieties nor does it differentiate between in situ research , collection , and use of biological and genetic re - and ex situ forest biological resources . sources for commercial and noncommercial purposes . In If approved , the draft ï쳌¬ ï쳌¡ ï쳌µ ï쳌¢ ï쳌§ ï쳌² will regulate access to ï?? ï?? ï?? ï?? , however , the Wildlife Act stated that bioprospecting biological , biochemical , and genetic resources and asso - would be defined as those activities implemented only for ciated knowledge found in in situ and ex situ conditions . commercial purposes . The act â?? covers all wildlife species Access is regulated for bioprospecting , industrial , and any including exotic species , which are subject to trade , cul - other economic use . The scope of the draft excludes ac - tured , maintained , bred in captivity , or propagated in the cess to human genetic resources and their derivatives and country â?쳌 . This act modified ï쳌¥ ï쳌¯ ï?? ï?? ï?? extensively . It excluded the exchange of genetic resources made by indigenous academic and scientific collection and research activities peoples and obtained from noncommercial uses , practices , from ï쳌¥ ï쳌¯ ï?? ï?? ï?? coverage . Today , the Wildlife Act covers and customs ( G ï쳌¡ ï쳌£ ï쳌¥ ï쳌´ ï쳌¡ P ï쳌¡ ï쳌² ï쳌¬ ï쳌¡ ï쳌­ ï쳌¥ ï쳌® ï쳌´ ï쳌¡ ï쳌² ï쳌© ï쳌¡ ï?? ï?? ï?? ï?? ) . these activities . The scope of the ï?? ï?? ï?? ï?? draft Guidelines Nicaragua : Draft Law of Biodiversity for Bioprospecting Activities in the Philippines ( see The scope of access activities will cover all in situ genetic endnote ï?? ï?? ) will cover any commercial bioprospecting of and biological resources and their associated knowledge , biological species carried out in the Philippines ( except innovations , and practices . The draft does not specifically for those accessed under international agreements where refer to biochemical resources and it does not apply to ex the Philippines is a party ) . The scope covers wildlife , mi - situ genetic resources . However , the scope of the Central croorganisms , domesticated or propagated species , exotic American Protocol on â?? Access to genetic and biochemi - species and all ex situ collections of biological resources cal resources , and their associated knowledge â?쳌 applies to sourced from the Philippines . The guidelines , however , these two issues . The protocol has already been signed by would not apply to collections related to traditional uses of the Central American nations and it will become national biological and genetic resources , subsistence consumption , law once it is ratified by them . Therefore , Nicaragua may and conventional commercial consumption . The scope invoke the protocol to facilitate access to biochemical and would also exclude logging or fishing , agrobiodiversity , ex situ genetic resources . and scientific activities such as taxonomic collections . The draft law excludes the following from its scope : a ) Perhaps agrobiodiversity is being excluded to facilitate human genetic resources and their derivatives ; b ) the uti - future implementation of the ï쳌¦ ï쳌¡ ï쳌¯ ï쳌© ï쳌´ ï쳌° ï쳌§ ï쳌² ï쳌¦ ï쳌¡ whose scope lization of genetic resources with purposes different from is restricted ( for now ) to the list of crops found in Annex their use as source of genetic resources ; c ) the exchange of 14 ï?? of the Treaty . Access to human genetic resources genetic resources and their associated knowledge made by and their derivatives is forbidden under the ï쳌¥ ï쳌¯ ï?? ï?? ï?? ( see indigenous and local communities according to traditional Chapter ï?? ) . practices ; d ) biosafety for pharmaceutical products ; and e ) the use of domestic species , but not their protection and Samoa : CABSSBR conservation ( ï쳌­ ï쳌¡ ï쳌² ï쳌¥ ï쳌® ï쳌¡ ï?? ï?? ï?? ï?? ) . The Samoan conditions cover access to biodiversity ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : D ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¯ ï쳌¦ P ï쳌¯ ï쳌¬ ï쳌© ï쳌£ ï쳌© ï쳌¥ ï쳌³ ï쳌© ï쳌® P ï쳌¬ ï쳌¡ ï쳌£ ï쳌¥ ï쳌¡ ï쳌® ï쳌¤ ï쳌© ï쳌® P ï쳌² ï쳌¯ ï쳌§ ï쳌² ï쳌¥ ï쳌³ ï쳌³ resources and traditional knowledge for commercial or Chapter ï?? ) : a ) adverse effects on the experiences of park visitors ; b ) a potential for negative impacts on the parkâ??s academic purposes . These include genetic resources , natural , cultural , or scenic resources , and particularly to organisms or parts of them , populations , and any other nonrenewable resources such as archeological and fossil component of ecosystems with potential use or value for sites or special - status species ; c ) a potential for creating humanity ( ï쳌¤ ï쳌¬ ï쳌³ ï쳌¥ ï?? ï?? ï?? ï?? ) . The scope does not mention or high risk of hazard to the researchers , other park visitors , or define the biochemical component . However , taking into environments adjacent to the park ; d ) extensive collecting account that the conditions have been used to regulate of natural materials or unnecessary replication of exist - benefits derived from the use of â?? prostratin â?쳌 ( a chemical ing voucher collections ; e ) need for substantial logistical , compound derived from the plant Homalanthus nutans ) administrative , curatorial , or project monitoring support ( C ï쳌¯ ï쳌¸ ï?? ï?? ï?? ï?? ) , it is reasonable to assume that the biochemical by park staff , or insufficient lead time to allow necessary component is included in the biological component of the review and consultation ; f ) conducting investigator lacks scope . The scope of the conditions does not address the scientific institutional affiliation and / or recognized expe - issue of access to ex situ genetic resources , and it does not rience in conducting scientific research ; and g ) lacking include exclusions to the type of genetic resources sought sufficient scientific detail for justification . by bioprospectors . Analysis : Scope Thailand : PVPA , RFSRCFA , and APPTMI Despite the fact that the scope of the ï쳌£ ï쳌¢ ï쳌¤ is limited to Access to Thailandâ??s in situ and ex situ biological and materials of biological origin that include functional units genetic resources and traditional knowledge is partially of heredity such as ï쳌¤ ï쳌® ï쳌¡ and ï쳌² ï쳌® ï쳌¡ , in practice , the scope of covered by these three laws . The ï쳌° ï쳌¶ ï쳌° ï쳌¡ regulates access to most ï쳌¡ ï쳌¢ ï쳌³ laws examined in this section is broader , includ - domestic and wild plant species ( including mushrooms and ing biological ( specimens and parts of specimens ) , genetic seaweed ) all over the country for commercial and noncom - ( ï쳌¤ ï쳌® ï쳌¡ and ï쳌² ï쳌® ï쳌¡ ) , and biochemical ( molecules , combination mercial purposes ( T ï쳌¨ ï쳌¡ ï쳌© ï쳌¬ ï쳌¡ ï쳌® ï쳌¤ C ï쳌¯ ï쳌® ï쳌§ ï쳌² ï쳌¥ ï쳌³ ï쳌³ ï?? ï?? ï?? ï?? ) . The ï쳌² ï쳌¦ ï쳌³ - of molecules , and extracts ) resources . The scope of most 15 ï쳌² ï쳌£ ï쳌¦ ï쳌¡ applies to natural , biological , and genetic resources of these ï쳌¡ ï쳌¢ ï쳌³ policies also applies to traditional knowledge found in forest conservation areas administered by ï쳌² ï쳌¦ ï쳌¤ and and is adamant about restricting access to human genetic protected areas managed by the Department of National resources and their derivatives . This broad scope has Parks , Wildlife , and Plant Conservation . ( C . Hutacharern , caused difficulties in countries such as Colombia and the pers . comm . June ï?? ï?? ï?? ï?? ) . It is not clear whether the scope Philippines ( see Chapters ï?? and ï?? ) . Also most policies in - of the regulation applies to ex situ collections . ï쳌¡ ï쳌° ï쳌° ï쳌´ ï쳌­ ï쳌© clude provisions excluding the use and exchange of genetic protects traditional knowledge about medicinal formulae resources made by indigenous communities . derived from plants , animals , bacteria , minerals , and ex - The main implication ofArticle ï?? ï?? ( ï?? ) of the ï쳌£ ï쳌¢ ï쳌¤ is that tracts of plants or animals used for diagnosing , treating , ex situ genetic resources collected before the ï쳌£ ï쳌¢ ï쳌¤ entered and preventing diseases , or promoting the health of humans into force are not covered by it . Therefore , some experts or animals . This knowledge includes both that which has argue that pre - ï쳌£ ï쳌¢ ï쳌¤ ex situ collections of genetic resources been passed on from generation to generation and that should not be covered by the scope of ï쳌¡ ï쳌¢ ï쳌³ laws or policies which is in the public domain and has been recorded in ( ï쳌´ ï쳌¥ ï쳌® K ï쳌¡ ï쳌´ ï쳌¥ and L ï쳌¡ ï쳌© ï쳌² ï쳌¤ ï?? ï?? ï?? ï?? , see Chapter ï?? ï?? ) . However , Thai books , palm leaf , stone inscription , or other materials in practice , most ï쳌¡ ï쳌¢ ï쳌³ policies cover these collections . In ( ï쳌® ï쳌© ï쳌´ ï쳌´ ï쳌­ ï?? ï?? ï?? ï?? ) . In case of conflict between ï쳌² ï쳌¦ ï쳌³ ï쳌² ï쳌£ ï쳌¦ ï쳌¡ and any case , procedures to access to pre or post - ï쳌£ ï쳌¢ ï쳌¤ ex situ the ï쳌° ï쳌¶ ï쳌° ï쳌¡ , the ï쳌° ï쳌¶ ï쳌° ï쳌¡ overrules ï쳌² ï쳌¦ ï쳌³ ï쳌² ï쳌£ ï쳌¦ ï쳌¡ . Additional conflict collections have not been clearly defined by the ï쳌¡ ï쳌¢ ï쳌³ polices issues between ï쳌¡ ï쳌¢ ï쳌³ policies are likely to be solved by a presented in this section . Ownership of these collections National Committee on Conservation and Utilization of is still controversial . Biological Diversity that was created by a Prime Minister Except for the Philippines ( draft Guidelines for Bio - Regulation on Conservation and Utilization of Biological prospecting Activities ) , access to agricultural genetic Diversity . Thailand is also planning to develop a law spe - resources is covered by the scope of ï쳌¡ ï쳌¢ ï쳌³ polices of all of cifically on medical research , which will be addressing these countries . So far Australia , Colombia , Costa Rica , human genetic resources and another law on endangered Ecuador , Malaysia , Nicaragua , Peru , and Thailand have species ( J . Donavanik , pers . comm . November ï?? ï?? ï?? ï?? ) . signed or acceded to the ï쳌¦ ï쳌¡ ï쳌¯ ï쳌© ï쳌´ ï쳌° ï쳌§ ï쳌² ï쳌¦ ï쳌¡ . The ï쳌µ ï쳌³ ï쳌¡ also signed it , but there is little probability that the ï쳌µ ï쳌³ ï쳌¡ Congress will USA : NPS research specimen collection permit ratify it . In any case , the ï쳌¦ ï쳌¡ ï쳌¯ ï쳌© ï쳌´ ï쳌° ï쳌§ ï쳌² ï쳌¦ ï쳌¡ entered into force Access to the biological diversity of ï쳌µ ï쳌³ ï쳌¡ national parks on ï?? ï?? June ï?? ï?? ï?? ï?? and present evidence indicates that these for research purposes ( commercial and noncommercial ) is countries ( except for the ï쳌µ ï쳌³ ï쳌¡ ) will exclude the food and governed by ï쳌® ï쳌° ï쳌³ specimen collection permit regulations . forage crops listed in Annex ï?? of the ï쳌© ï쳌´ ï쳌° ï쳌§ ï쳌² ï쳌¦ ï쳌¡ from the These regulations have been implemented since ï?? ï?? ï?? ï?? and scope of their national ï쳌¡ ï쳌¢ ï쳌³ laws and policies . permits for the collection of biological samples throughout the ï쳌® ï쳌° ï쳌³ are issued routinely . Permits regulate access to the Access Procedure biological resource and the genetic material it contains . Access , however , can be denied if the proposed research Obtaining access can be a long , confusing , and cumber - activity has any of the following characteristics ( see some process . Access permits may have to be obtained ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ from several regional and local agencies that administer reasonable grounds to believe that access to this collec - the same resource . In addition , bioprospectors may have tion is administered consistently with the purpose of the to negotiate with several providers of genetic resources regulations and b ) there are reasonable grounds to be - and traditional knowledge . This bureaucracy and overlap - lieve that access to the resources is controlled by another ping of functions can lead to high transaction costs and Commonwealth department or agency , self - governing long processing times for required permits . This section territory , or state law , consistent with the purpose of the discusses the main similarities and differences regarding regulations . Due to ownership issues access procedures to access procedures of the selected countries and presents ex situ collections have not been defined yet . Holders of the access definitions proposed by some countries in their such collections and the Department will discuss potential ï쳌¡ ï쳌¢ ï쳌³ laws and policies . solutions to this problem ( see Chapter ï?? ) . Australia : Draft EPBCAR Colombia , Ecuador , and Peru : Decision 391 Access to biological resources is defined as the collection Access is defined as obtaining and using ex situ and in process and use of organisms , their parts , genetic material , situ genetic resources , their derivatives , and associated and biochemical make - up for conservation , commercial , knowledge with research , bioprospecting , conservation , industrial , or taxonomic research purposes . According to industrial application , and commercial use , among others . the draft regulations bioprospectors ( with commercial Decision ï?? ï?? ï?? proposes an access contract to be negotiated 16 and noncommercial purposes ) have to obtain a permit between the bioprospector and the Competent National to access biological resources in Commonwealth areas Authority ( ï쳌£ ï쳌® ï쳌¡ ) in the member country where resources and establish benefit - sharing agreements with the provid - are sought . Prior to the negotiation of the contract the bio - 17 ers of these resources . Permits are valid for a maximum prospector has to present an application for access to the of three years and the cost of a permit is the same for all relevant ï쳌£ ï쳌® ï쳌¡ . The application must include : a ) information applicants ( national or international , commercial or non - about the applicant , including its legal capacity to enter commercial ) : ï?? ï?? ï?? ï쳌¡ ï쳌µ ï쳌¤ for access and no payment for a into a contract ; b ) the identity of the supplier of genetic transfer of the permit or variation or revocation of a permit or biological resources and their derivatives and / or of the condition . Benefits are to be negotiated on a case - by - case associated intangible component ( or knowledge ) ; c ) the basis and the benefit - sharing agreement takes effect only if identity of the national support institution or individual ; d ) a permit is issued . The regulations establish that biopros - the identity and curriculum vitae of the project leader and pectors have to submit applications for access permits to team ; e ) the nature of the access activity being requested ; the Secretary of the Department of the Environment and and f ) the area in which the access will be made including Heritage . the geographic coordinates . The application must include Once the Secretary has received the benefit - shar - a project proposal based on a model provided by the ï쳌£ ï쳌® ï쳌¡ . ing agreement ( including the ï쳌° ï쳌© ï쳌£ requirement ) and the Then , the ï쳌£ ï쳌® ï쳌¡ has ï?? ï?? working days ( extendable to ï?? ï?? ) to permit application , he or she must give a report to the evaluate the application . If the ï쳌£ ï쳌® ï쳌¡ is satisfied with the Minister for the Environment and Heritage within ï?? ï?? application , it is placed on the official record and noncon - days of their receipt . This time can be extended if the fidential information is available for public scrutiny in the authorities require the following information : a ) whether national official gazette . Otherwise , the application may be the environmental impact assessment ( ï쳌¥ ï쳌© ï쳌¡ ) ( if required ) returned to the applicant for more information or denied . was undertaken and completed ; b ) relevant information A successful application will lead to the negotiation from the Commonwealth department or agency ; c ) ad - of the â?? access contract â?쳌 . The parties to the contract are ditional information about the proposed benefit - sharing the applicant and the ï쳌£ ï쳌® ï쳌¡ . The ï쳌£ ï쳌® ï쳌¡ also needs to take agreement ; d ) whether bioprospectors complied with the into account the interests of other Andean countries and regulations requiring consultation with the providers of of the suppliers of the biological resources and intangible genetic resources ; e ) the views of any representative of component ( traditional knowledge ) in the negotiation of the Aboriginal and Torres Strait Islander body within the the access contract . Therefore , the applicant must negotiate meaning of the Native Title Act of ï?? ï?? ï?? ï?? ; and f ) whether an annex contract with the supplier of the knowledge and the access provider has received independent legal advice an accessory contract with the supplier of the biological about the regulation . If the Minister decides not to grant resource that contains the biochemical or genetic compo - the permit , the bioprospector can appeal through the courts nent . The provider of the biological resource can be the under the ï?? ï?? ï?? ï?? Administrative Decisions ( Judicial Review ) holder of the land or the ex situ conservation center where Act . Detailed administrative arrangements for the handling the biological resource is found . Accessory contracts can of access applications can be expected to be developed also be signed with national support institutions that are once the regulations are enacted not included in the access contract . Annex and accessory Under this regulation , the Minister may declare contracts cannot authorize access to the resource by them - that the permit provisions do not apply to biological selves . Access is only granted through the access contract resources if : a ) these resources are held in a collection negotiated with the ï쳌£ ï쳌® ï쳌¡ ( see Chapter ï?? ) . Peruâ??s Law No . by a Commonwealth department or agency and there are ï?? ï?? ï?? ï?? ï?? endorses the use of an annex contract or license . ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : D ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¯ ï쳌¦ P ï쳌¯ ï쳌¬ ï쳌© ï쳌£ ï쳌© ï쳌¥ ï쳌³ ï쳌© ï쳌® P ï쳌¬ ï쳌¡ ï쳌£ ï쳌¥ ï쳌¡ ï쳌® ï쳌¤ ï쳌© ï쳌® P ï쳌² ï쳌¯ ï쳌§ ï쳌² ï쳌¥ ï쳌³ ï쳌³ Under this law , commercial bioprospectors have to identify ties associated with the holders of genetic resources and the community or communities that hold the collective also because there are other national laws not necessarily knowledge and sign a license with them . Such a license related to access that regulate ex situ collections . The ï쳌§ ï쳌¡ ï쳌° has to be registered before the Peruvian National Institute provides ï?? months for the drafting of an access procedure for the Defense and Protection of Traditional Knowledge for ex situ genetic resources and establishes a moratorium ( ï쳌© ï쳌® ï쳌¤ ï쳌¥ ï쳌£ ï쳌¯ ï쳌° ï쳌© ) ( P ï쳌¥ ï쳌² ï쳌µ ï쳌¶ ï쳌© ï쳌¡ ï쳌® C ï쳌¯ ï쳌® ï쳌§ ï쳌² ï쳌¥ ï쳌³ ï쳌³ ï?? ï?? ï?? ï?? ) . on the access of ex situ genetic resources until such pro - cedure is adopted . Costa Rica : The Law of Biodiversity The Law of Biodiversity requires a determination of Access to biochemical and genetic elements is defined the administrative fee . The ï쳌§ ï쳌¡ ï쳌° states that this fee is a fifth as the action of obtaining samples from in situ or ex situ of the minimum wage . After the ï쳌´ ï쳌¯ issues a certificate elements of indigenous or domestic biodiversity and their of origin , it publishes the requests and final resolutions associated knowledge , for the purposes of basic research , on its website within eight calendar days . An ï쳌¥ ï쳌© ï쳌¡ can be economic benefit , or bioprospecting . Bioprospecting is de - requested by the ï쳌´ ï쳌¯ . Its evaluation is the responsibility of fined as the systematic search , classification , and research the National Technical Secretariat ( see Chapter ï?? ) . ( with commercial purposes ) of new sources of chemical compounds , genes , proteins , microorganisms , and other Malaysia : products that have present or potential economic value Draft federal bill on access to genetic resources with commercial purposes . The draft bill defines access as all activities relating to bio - Under this law local and foreign bioprospectors are prospecting , collection , commercial utilization , research , required to obtain access permits to obtain genetic or and development of biological resources or the associated biochemical resources and their associated knowledge . relevant community knowledge and innovations . If the These are valid for three years and can be renewed , but draft bill is adopted , both foreign and local bioprospectors are not transferable . First , in conformity with the â?? General will have to follow the same basic access procedure in 18 Access Procedure â?쳌 ( ï쳌§ ï쳌¡ ï쳌° ) interested parties must register order to obtain access to genetic resources for commercial with the Technical Office ( ï쳌´ ï쳌¯ ) of the National Commission purposes . But international bioprospectors will have ad - for the Management of Biodiversity ( ï쳌£ ï쳌¯ ï쳌® ï쳌¡ ï쳌§ ï쳌¥ ï쳌¢ ï쳌© ï쳌¯ ) . The ditional conditions for approval of the access application . application includes : a ) identification of the interested For example , the application will require foreign biopros - party ; b ) identification of the responsible researcher ; c ) pectors to have a local collaborating organization to both exact location of place where samples will be collected ; sponsor the collection and be responsible for actions of d ) the elements of biodiversity that will be the subject of the collector . The local organization will also participate the investigation ; e ) the owner and manager or holder of in the collection , research , and development of samples the premises ; f ) a list of activities , aims , and purposes ; collected . and g ) an address for legal notifications . Later , the ï쳌° ï쳌© ï쳌£ Both national and international bioprospectors will be must be negotiated between the applicant and the owner required to sign an access agreement with the competent of the conservation area or indigenous land , resources , or authority and the relevant resource provider . However , the ex situ collections . relevant authority may decide that the restrictions relat - The permits will contain a certificate of origin , permis - ing to access to resources shall not apply to Malaysian sion or prohibition to extract samples , periodic reporting researchers conducting noncommercial bioprospecting obligation , monitoring and control , conditions relative to activities . The procedure for foreign scientists who want resulting property , and any another applicable condition to obtain access for noncommercial purposes is still not stated by the ï쳌´ ï쳌¯ . Different requirements are established for clear at this point . The financial costs of applying for ac - those who request permits for noncommercial bioprospect - cess have not been determined yet , but it is not likely to 19 ing and for those who need access permits for occasional deter bioprospectors from applying . 20 or continuing economic utilization . At this stage there is There shall be no access to biological resources or no information about the duration of these procedures . In community knowledge and innovation without an access any case , the current scheme empowers the owners of the license granted by the competent authority . Information lands where biological resources are found to negotiate required in the application for the license includes : a ) iden - contracts ( by means of the ï쳌° ï쳌© ï쳌£ ) with bioprospectors . tification of the collector ; b ) identification of material to In case of ex situ collections , different rules will be be collected or knowledge to be accessed ; c ) identification proposed for framework agreements that authorize the of collection sites ; d ) quantity and intended use of the transfer of multiple materials . In such cases material resource ; e ) time when the access activity is to be carried transfer agreements ( ï쳌­ ï쳌´ ï쳌¡ s ) will have to be standardized out ; e ) ï쳌¥ ï쳌© ï쳌¡ ; f ) ï쳌° ï쳌© ï쳌£ certificate ; g ) benefit - sharing arrange - and approved by the ï쳌´ ï쳌¯ . The Law of Biodiversity also ments ; and h ) identification of the local collaborator or requires all holders of ex situ genetic resources to register sponsor ( a Malaysian institution ) . This information can with the ï쳌´ ï쳌¯ . Bioprospectors will have to obtain a permit be made available to the public . Once the application has in order to access ex situ genetic resources . However , no been reviewed it can be approved , returned to the applicant procedure has been defined yet because of the complexi - if more information is required , or rejected.A decision can ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ be appealed at any time within three months of the date of to indigenous and local communities for obtaining permits receipt of the decision.Access procedures to ex situ collec - and authorizations under either ï쳌¥ ï쳌¥ ï쳌¥ ï쳌° ï쳌§ ï쳌¡ or ï쳌· ï쳌§ ï쳌¡ . Under tions have not been defined yet ( see Chapter ï?? ï?? ) . ï쳌³ ï쳌¦ ï쳌¤ ï쳌§ ï쳌¡ , collections of forest biological resources carried out by public entities of the federal , state , or municipal Mexico : EEEPGA , WGA , SFDGA , and draft LAUBGR governments or the owner of the land , need only to sub - ï쳌¥ ï쳌¥ ï쳌¥ ï쳌° ï쳌§ ï쳌¡ , ï쳌· ï쳌§ ï쳌¡ , and ï쳌³ ï쳌¦ ï쳌¤ ï쳌§ ï쳌¡ do not include an access defi - mit a notification in accordance with the pertinent official nition . But collection of biological resources under any Mexican norm and the consent of the owner of the land of these laws requires a permit from the Secretariat of ( ï쳌³ ï쳌¥ ï쳌­ ï쳌¡ ï쳌² ï쳌® ï쳌¡ ï쳌´ ï?? ï?? ï?? ï?? ) . Environment and Natural Resources ( ï쳌³ ï쳌¥ ï쳌­ ï쳌¡ ï쳌² ï쳌® ï쳌¡ ï쳌´ ) . Under On the other hand , the draft ï쳌¬ ï쳌¡ ï쳌µ ï쳌¢ ï쳌§ ï쳌² defines access Article ï?? ï?? and ï?? ï?? ï쳌¢ ï쳌© ï쳌³ of ï쳌¥ ï쳌¥ ï쳌¥ ï쳌° ï쳌§ ï쳌¡ , local and foreign bio - as the action of obtaining samples from in situ or ex situ prospectors have to apply to ï쳌³ ï쳌¥ ï쳌­ ï쳌¡ ï쳌² ï쳌® ï쳌¡ ï쳌´ in order to obtain elements of indigenous or domestic biodiversity and their access to genetic resources for scientific ( noncommercial ) , associated knowledge with economic or bioprospecting economic ( for reproduction and commercial activities ) and purposes . The draft law would regulate only commercial biotechnology purposes . Under Article ï?? ï?? of ï쳌¥ ï쳌¥ ï쳌¥ ï쳌° ï쳌§ ï쳌¡ and activities , leaving noncommercial applications to the cur - Article ï?? ï?? of ï쳌· ï쳌§ ï쳌¡ access for scientific or noncommercial rent regulatory framework . The access procedure includes purposes requires a permit or a license for a researcher the following steps : a ) the applicant must obtain an autho - with a specific line of work . Both laws require the ï쳌° ï쳌© ï쳌£ rization from a Federal Executive Authority ( ï쳌³ ï쳌¥ ï쳌­ ï쳌¡ ï쳌² ï쳌® ï쳌¡ ï쳌´ ) ; of the landowner , report submissions , and deposit of at b ) an access contract must be signed with ï쳌³ ï쳌¥ ï쳌­ ï쳌¡ ï쳌² ï쳌® ï쳌¡ ï쳌´ , the least one duplicate of the material collected in a local provider of the biological and genetic resource , and the institution or scientific collection . Authorization under provider of the traditional knowledge ; c ) if relevant , an these laws cannot be extended to commercial purposes , authorization must be obtained either for collection done and nonconfidential research results must be available to by an ex situ conservation body , transport to any area not the public . However , Mexican legislation recognizes that specified in the access agreement , export of the material scientific or academic collections can later be used for collected , or transfer of the rights and obligations given by industrial or commercial applications . If this is the case the access authorization . The draft bill , however , does not norm ï쳌® ï쳌¯ ï쳌­ - ï?? ï?? ï?? - ï쳌¥ ï쳌£ ï쳌¯ ï쳌¬ - ï?? ï?? ï?? ï?? mandates a new declaration define the procedure and requirements for authorization for stating a change of purpose , thus setting the stage for ex situ collections . Requirements for an ï쳌¥ ï쳌© ï쳌¡ are not clearly new ï쳌° ï쳌© ï쳌£ and ï쳌¡ ï쳌¢ ï쳌³ contracts . Chapter ï?? suggests that this regulated and the participation of Mexicans in research measure has a low transaction cost because the change in and development is required ( G ï쳌¡ ï쳌£ ï쳌¥ ï쳌´ ï쳌¡ P ï쳌¡ ï쳌² ï쳌¬ ï쳌¡ ï쳌­ ï쳌¥ ï쳌® ï쳌´ ï쳌¡ ï쳌² ï쳌© ï쳌¡ the ï쳌° ï쳌© ï쳌£ and the negotiation of the ï쳌¡ ï쳌¢ ï쳌³ contract would hap - ï?? ï?? ï?? ï?? ) . pen only after a finding that the biological resource has a commercial application . However , an argument could be Nicaragua : Draft Law of Biodiversity made that under controversial social and political circum - Access is defined as the action of obtaining samples from stances ( see Chapter ï?? ) the costs of the delay that would biological and genetic resources and their associated be generated after a discovered commercial application knowledge , practices , and innovations . Details about ac - could be very high . cess procedures for genetic resources found in ex situ and Under Article ï?? ï?? ï?? of ï쳌³ ï쳌¦ ï쳌¤ ï쳌§ ï쳌¡ collectors and users of in situ conditions have not been defined yet . However , forest biological resources for scientific , economic , or the draft Law of Biodiversity states that all domestic and biotechnological purposes have to apply for authoriza - foreign bioprospectors will have to obtain an authoriza - tion to ï쳌³ ï쳌¥ ï쳌­ ï쳌¡ ï쳌² ï쳌® ï쳌¡ ï쳌´ . This application must include the ï쳌° ï쳌© ï쳌£ tion from the National Biodiversity Institute in order to of the owner of the land that provided the resources . It obtain access to biological and genetic resources . Such should be noted that under ï쳌³ ï쳌¦ ï쳌¤ ï쳌§ ï쳌¡ and article ï?? ï?? ï쳌¢ ï쳌© ï쳌³ of authorization must include : a ) the ï쳌° ï쳌© ï쳌£ of the provider of the ï쳌¥ ï쳌¥ ï쳌¥ ï쳌° ï쳌§ ï쳌¡ collectors must present the ï쳌° ï쳌© ï쳌£ in order to obtain biological and genetic resource as well as the traditional government authorization . In contrast , under article ï?? ï?? knowledge and b ) a description about the intent to sign of ï쳌¥ ï쳌¥ ï쳌¥ ï쳌° ï쳌§ ï쳌¡ and ï쳌· ï쳌§ ï쳌¡ , the ï쳌° ï쳌© ï쳌£ is not required to obtain this accessory contracts with local or foreign organizations or a authorization but it is required before collecting activities description of accessory contracts signed with these parties are initiated ( see Chapter ï?? ) . before the law came into force . The authorization will also According to Article ï?? ï?? ï?? of ï쳌³ ï쳌¦ ï쳌¤ ï쳌§ ï쳌¡ , commercial require a permit showing that an ï쳌¥ ï쳌© ï쳌¡ was carried out ( if and noncommercial bioprospectors that use traditional required ) . Access to genetic resources may be denied if : knowledge must submit an agreement to ï쳌³ ï쳌¥ ï쳌­ ï쳌¡ ï쳌² ï쳌® ï쳌¡ ï쳌´ that a ) the access application is determined to include false in - includes the ï쳌° ï쳌© ï쳌£ of the indigenous community that provided formation ; b ) the applicant has attempted to access genetic the knowledge . This agreement must also acknowledge resources illegally in the country or overseas ; c ) access the property rights of indigenous communities to their activities cause the endangerment or extinction of species ; knowledge . ï쳌³ ï쳌¥ ï쳌­ ï쳌¡ ï쳌² ï쳌® ï쳌¡ ï쳌´ evaluates the application and or d ) access activities cause ecological , social , cultural , or ensures that a benefit - sharing agreement is negotiated economic impacts that cannot be mitigated . Bioprospectors with the providers of genetic resources . The ï?? ï?? ï?? ï?? Rural will also have to deposit duplicates of specimens collected Sustainable Development Act ( ï쳌² ï쳌³ ï쳌¤ ï쳌¡ ) gives priority rights in local ex situ conservation centers . The draft law also ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : D ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¯ ï쳌¦ P ï쳌¯ ï쳌¬ ï쳌© ï쳌£ ï쳌© ï쳌¥ ï쳌³ ï쳌© ï쳌® P ï쳌¬ ï쳌¡ ï쳌£ ï쳌¥ ï쳌¡ ï쳌® ï쳌¤ ï쳌© ï쳌® P ï쳌² ï쳌¯ ï쳌§ ï쳌² ï쳌¥ ï쳌³ ï쳌³ states that â?? framework agreements â?쳌 will be established knowledge must state this purpose in the research pro - posal . The draft Guidelines provide a detailed procedure between the government and universities or other users of for the negotiation and execution of the Bioprospecting genetic resources for noncommercial purposes ( ï쳌­ ï쳌¡ ï쳌² ï쳌¥ ï쳌® ï쳌¡ Undertaking with an emphasis on standardizing and ï?? ï?? ï?? ï?? ) . The draft law of biodiversity implements Article streamlining the procedure for access . The application ï?? ï?? of ï쳌§ ï쳌¬ ï쳌¥ ï쳌® ï쳌² which requires an authorization for studies must include the proposal and documentation that all on biotechnology ( ï쳌­ ï쳌¡ ï쳌² ï쳌¥ ï쳌® ï쳌¡ ï?? ï?? ï?? ï?? ) . This authorization has required items ( such as ï쳌° ï쳌© ï쳌£ and any benefit - sharing terms to be given by the national competent authority which in negotiated and approved by the resource providers ) have this case is the National Biodiversity Institute . been obtained . The agency receiving the application ( the Philippines : EO 247 and Wildlife Act Protected Areas Wildlife Bureau ( ï쳌° ï쳌¡ ï쳌· ï쳌¢ ) of ï쳌¤ ï쳌¥ ï쳌® ï쳌² , the ï쳌¥ ï쳌¯ ï?? ï?? ï?? does not define the concept of access . However , it Bureau of Fisheries and Aquatic Resources , or ï쳌° ï쳌£ ï쳌³ ï쳌¤ ) can be argued that this policy uses the concept â?? prospecting will draft the Bioprospecting Undertaking incorporating or bioprospecting â?쳌 as a proxy for â?? access â?쳌 . Bioprospecting the terms agreed upon by the applicant and the resource is defined as the research , collection , and utilization of providers and forward it to their respective or joint tech - biological and genetic resources for purposes of applying nical committees for review . Their final evaluation must the knowledge derived from these resources to scientific be completed within ï?? ï?? days of receipt of application and commercial purposes . Under ï쳌¥ ï쳌¯ ï?? ï?? ï?? , local and foreign and it is forwarded to the appropriate agency signatories . bioprospectors must apply for access to genetic resources The goal is for the agency decision to be made within for commercial and noncommercial purposes.Applications one month from the submission of the application . If the for Academic Research Agreements ( ï쳌¡ ï쳌² ï쳌¡ ) or Commercial Bioprospecting Undertaking is approved , the applicant will ResearchAgreements ( ï쳌£ ï쳌² ï쳌¡ ) are submitted to the Technical sign it along with the appropriate signatories , respecting Secretariat for an initial evaluation . Then , they are passed the terms negotiated with resource providers , and including to the Inter - Agency Committee on Biological and Genetic the standard terms and conditions under the guidelines . Resources ( ï쳌© ï쳌¡ ï쳌£ ï쳌¢ ï쳌§ ï쳌² ) and the ï쳌© ï쳌¡ ï쳌£ ï쳌¢ ï쳌§ ï쳌² makes a recommen - Bioprospecting may then proceed once the required per - formance and rehabilitation bond is posted . dation to the pertinent agency . Foreign applicants must involve a local institution in the research process . ï쳌¥ ï쳌¯ ï?? ï?? ï?? Samoa : CABSSBR does not provide for a specific timeframe within which This policy does not define the concept of access . to process applications . However , it usually takes about Bioprospectors must submit an application form to five months or longer because the ï쳌© ï쳌¡ ï쳌£ ï쳌¢ ï쳌§ ï쳌² is required to the Director of the Department of Lands , Surveys and meet once every four months , although the chairman can Environment ( ï쳌¤ ï쳌¬ ï쳌³ ï쳌¥ ) . There is an application fee of ï?? ï?? ï?? ï?? call for special meetings . Also , the application process is ï쳌µ ï쳌³ ï쳌¤ and ï?? ï?? % of it is returned if the application is unsuc - often slow due to delays in obtaining the ï쳌° ï쳌© ï쳌£ . Depending cessful ( the remaining ï?? ï?? % is used for processing costs ) . on whether it is an ï쳌¡ ï쳌² ï쳌¡ or a ï쳌£ ï쳌² ï쳌¡ that is sought , certain Upon receipt of the application , ï쳌¤ ï쳌¬ ï쳌³ ï쳌¥ is required to consult distinctions are incorporated in the application process with pertinent government bodies and publicize the appli - ( see Table ï?? of Chapter ï?? ) . cation . The evaluation process can take up to ï?? ï?? working The Wildlife Act , however , modified ï쳌¥ ï쳌¯ ï?? ï?? ï?? substan - days . The access permit is valid for a year and it can be tially and excluded the collection and use of biological renewed for an additional year . The applicant must also resources for academic or scientific purposes . Therefore , obtain an export permit in order to export any specimen out an ï쳌¡ ï쳌² ï쳌¡ is no longer required . The Wildlife Act states that of Samoa ( ï쳌¤ ï쳌¬ ï쳌³ ï쳌¥ ï?? ï?? ï?? ï?? ) . ï쳌£ ï쳌¡ ï쳌¢ ï쳌³ ï쳌³ ï쳌¢ ï쳌² does not provide details the collection and use of biological resources for academic about access procedures for ex situ genetic resources and or scientific purposes can be undertaken through a free it does not differentiate between commercial and noncom - permit . The Department of Environment and Natural mercial collectors of biological resources . Resources ( ï쳌¤ ï쳌¥ ï쳌® ï쳌² ) , the Department of Agriculture ( ï쳌¤ ï쳌¡ ) , and the Palawan Council for Sustainable Development Thailand : PVPA , RFSRCFA , and APPTMI ( ï쳌° ï쳌£ ï쳌³ ï쳌¤ ) are in charge of implementing the Wildlife Act ( P . These laws and policies do not define the concept of ac - Benavidez , pers . comm . February ï?? ï?? ï?? ï?? ) . cess . However , access procedures are quite detailed . Before Under the ï?? ï?? ï?? ï?? draft Guidelines for Bioprospecting entering the country foreign bioprospectors have to apply 21 Activities ( see endnote ï?? ï?? ) commercial bioprospectors to ï쳌® ï쳌² ï쳌£ ï쳌´ for permission to conduct research in Thailand . must pay a fee of ï?? ï?? , ï?? ï?? ï?? ï쳌µ ï쳌³ ï쳌¤ for each Bioprospecting According to regulation ï쳌¢ . ï쳌¥ . ï?? ï?? ï?? ï?? of ï쳌® ï쳌² ï쳌£ ï쳌´ , bioprospectors Undertaking ( which replaces the ï쳌£ ï쳌² ï쳌¡ of ï쳌¥ ï쳌¯ ï?? ï?? ï?? ) and such have to fill out form ï쳌® ï쳌² ï쳌£ ï쳌´ - ï?? ï?? and submit it to ï쳌® ï쳌² ï쳌£ ï쳌´ no less fee may be modified depending on whether the applicant than ï?? ï?? days prior to entering the country . Together with is a national and other criteria . In addition , bioprospectors this application ï쳌® ï쳌² ï쳌£ ï쳌´ requires two letters of endorsement must pay ï?? ï?? , ï?? ï?? ï?? ï쳌µ ï쳌³ ï쳌¤ per collection site annually during from local researchers . A letter of permission from ï쳌® ï쳌² ï쳌£ ï쳌´ the collection period . According to the guidelines access is required to obtain the visa at the Royal Thai Embassy to biological resources does not imply automatic access or Consulate . Within ï?? days of arriving in Thailand , the to traditional knowledge associated with these resources . applicant has to report to ï쳌® ï쳌² ï쳌£ ï쳌´ , pay a processing fee of A bioprospector wishing to access associated traditional ï?? ï?? ï?? ï?? Baht per researcher , and obtain an identification ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ card . Then , the applicant can apply for access to genetic ( J . Donavanik , pers . comm . January ï?? ï?? ï?? ï?? ) . Under ï쳌¡ ï쳌° ï쳌° ï쳌´ ï쳌­ ï쳌© , whoever wishes to use traditional resources under the ï쳌° ï쳌¶ ï쳌° ï쳌¡ or ï쳌² ï쳌¦ ï쳌³ ï쳌² ï쳌£ ï쳌¦ ï쳌¡ . knowledge protected in the registrar must apply to the Under the ï쳌° ï쳌¶ ï쳌° ï쳌¡ , local and foreign commercial bio - Permanent Secretary of the Ministry of Public Health . prospectors have to file a petition with the Department ï쳌¡ ï쳌° ï쳌° ï쳌´ ï쳌­ ï쳌© also protects plants , animals , bacteria , and min - of Agriculture and then obtain a ï쳌° ï쳌© ï쳌£ from the holders of erals that are of study and research value , have important local genetic resources . When wild plant varieties are economic value or may become extinct . The commercial used , they have to establish a benefit - sharing agreement use or export of these species requires a license from the with the government and sometimes with the provider of Permanent Secretary of the Ministry of Public Health the resource ( J . Donavanik , pers . comm . January ï?? ï?? ï?? ï?? ) . ( ï쳌® ï쳌© ï쳌´ ï쳌´ ï쳌­ ï?? ï?? ï?? ï?? ) . The act states that collectors of wild plant varieties that have commercial purposes have to present the following USA : NPS research specimen collection permit information to pertinent authorities : a ) the purpose of the Under ï쳌® ï쳌° ï쳌³ regulations , bioprospectors can access national collection ; b ) the amount or quantity of samples of the park genetic resources through a collection permit process intended plant variety ; c ) the obligations of the person to that has been in place since ï?? ï?? ï?? ï?? . The regulations apply whom permission is granted ; d ) intellectual property rights to commercial and noncommercial bioprospectors as long which may result from the development , study , experiment , as they engage in scientific research activities . Researches or research activities ; e ) the amount or rate of , or the term must apply for a permit on the National Park Serviceâ??s for , the profit sharing under the profit - sharing agreement 22 Research Permit and Reporting System website . The with respect to products derived from the use of the plant following information is asked for to successfully com - variety thereunder ; f ) the term of the agreement ; g ) the plete the application process for such a permit : a ) contact revocation of the agreement ; h ) dispute settlement proce - information about the applicant ( required ) ; b ) project title dure ; and i ) other items or particulars as prescribed in the ( required ) ; c ) purpose of study ( required ) ; d ) study start Ministerial Regulation . Collectors of plant material with and end dates ( required ) ; e ) identification of any federal noncommercial purposes will have to follow a regulation funding agencies ; f ) location of activity in the park ; g ) that has yet to be developed by the Plant Variety Protection method of access ; h ) names of co - applicants ; i ) if you are Commission ( T ï쳌¨ ï쳌¡ ï쳌© ï쳌¬ ï쳌¡ ï쳌® ï쳌¤ C ï쳌¯ ï쳌® ï쳌§ ï쳌² ï쳌¥ ï쳌³ ï쳌³ ï?? ï?? ï?? ï?? ) . collecting specimens , contact information of repositories ; Under ï쳌² ï쳌¦ ï쳌³ ï쳌² ï쳌£ ï쳌¦ ï쳌¡ , national and foreign bioprospectors j ) a copy of the study proposal ; and k ) a copy of all peer have to submit an application and a â?? full project pro - reviews . posal â?쳌 ( translated into Thai ) to the ï쳌² ï쳌¦ ï쳌¤ . ï쳌² ï쳌¦ ï쳌³ ï쳌² ï쳌£ ï쳌¦ ï쳌¡ provides Once the application has been filed ( this is equivalent ï?? ï?? days for the review of the application and proposal . A to the ï쳌° ï쳌© ï쳌£ ) , ï쳌® ï쳌° ï쳌³ officials and outside experts review its Research Proposal Reviewing Subcommittee ( ï쳌² ï쳌° ï쳌² ï쳌³ ) and content for issues that include : a ) scientific validity ; b ) the director of the area where samples will be collected researcher and institutional qualifications ; c ) benefit to the examine these materials and give a recommendation to ï쳌® ï쳌° ï쳌³ and the public ; d ) actual or potential impacts to park the Director General of ï쳌² ï쳌¦ ï쳌¤ . A positive recommendation resources ; and e ) impacts on visitor experiences , wilder - will result in an access permit that is submitted to ï쳌® ï쳌² ï쳌£ ï쳌´ ness , and safety . Reviewers may recommend denial or ac - and then delivered to the applicant . It should be noted that ceptance of the permit application at this stage . If accepted , if the proposal has a negative review from the director the benefits and risks of the proposal are analyzed under of the collection area , then the permit could be denied . the National Environmental Policy Act ( ï쳌® ï쳌¥ ï쳌° ï쳌¡ ) . Then the The final access permit must include the signatures of the reviewers make a recommendation to the Superintendent Director General of ï쳌² ï쳌¦ ï쳌¤ , the secretary of the ï쳌² ï쳌° ï쳌² ï쳌³ , and the or designee to approve or reject the permit request . If the Director of the Department of National Parks , Wildlife application is approved , the permit and attached condi - and Plant Conservation . The ï쳌² ï쳌¦ ï쳌¤ will also inform the staff tions ( including requirement for annual accomplishment that must accompany bioprospectors during the site visits . report ) are sent to applicant for signature . If the applica - Upon reception of the access permit and ï?? ï?? days before tion is rejected , there is an opportunity for revising and entering the collection site , the applicant must notify resubmitting the application . This process usually takes the Director General of ï쳌² ï쳌¦ ï쳌¤ and local forestry officials less than three months ( see Chapter ï?? ) . ( C . Hutacharern , pers . comm . June ï?? ï?? ï?? ï?? ) . The terms of the agreements can vary between one and five years or Analysis : Access Procedure more , but each agreement has to be reviewed annually to Most of the above laws and policies define access as the ensure compliance . An application fee must also be paid action of collecting and using biological , biochemical , ( C ï쳌¨ ï쳌¡ ï쳌¬ ï쳌¥ ï쳌² ï쳌­ ï쳌° ï쳌¯ ï쳌® ï쳌§ ï쳌³ ï쳌¥ ï?? ï?? ï?? ï?? ) . and genetic resources and their associated knowledge for Bioprospectors may have to use an ï쳌­ ï쳌´ ï쳌¡ in order to ob - commercial and noncommercial purposes . All of the laws tain access to genetic resources found in ex situ collections and policies reviewed in this section have in common at or in geographical areas not covered by ï쳌° ï쳌¶ ï쳌° ï쳌¡ and ï쳌² ï쳌¦ ï쳌³ ï쳌² ï쳌£ ï쳌¦ ï쳌¡ . least the following main steps for access : a ) submission of However , procedures about how to apply for access to ge - an access application to a designated national competent netic resources under ï쳌­ ï쳌´ ï쳌¡ s have not been officially stated authority ; b ) review of the application ; c ) approval or de - and they may vary according to the holder of the resource nial of the application ( if denied there is a legal recourse ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : D ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¯ ï쳌¦ P ï쳌¯ ï쳌¬ ï쳌© ï쳌£ ï쳌© ï쳌¥ ï쳌³ ï쳌© ï쳌® P ï쳌¬ ï쳌¡ ï쳌£ ï쳌¥ ï쳌¡ ï쳌® ï쳌¤ ï쳌© ï쳌® P ï쳌² ï쳌¯ ï쳌§ ï쳌² ï쳌¥ ï쳌³ ï쳌³ to appeal ) ; and d ) negotiation of ï쳌° ï쳌© ï쳌£ and benefit - sharing implication of such a comprehensive scope is that these ï쳌¡ ï쳌¢ ï쳌³ laws and policies apply to national and international requirements . However , the length of the access process representatives of the pharmaceutical , seed , crop protec - varies across countries and depends largely on the length of tion , botanical medicine , food , and all other industries negotiation of ï쳌° ï쳌© ï쳌£ and benefit - sharing agreements with the that use biological , genetic , and biochemical elements providers of genetic resources and traditional knowledge to develop processes and products . Therefore , to deal ef - and in some cases with national authorities . ficiently with a large number of applicants , these countries But should States be directly involved in the benefit - may have to design more practical access criteria . These sharing negotiation of each bioprospecting project ? Should criteria would translate into practical access procedures they be parties to each benefit - sharing contract ? Or should that differentiate between an industry that uses modern this negotiation be carried out only by the direct providers biotechnology techniques such as genetic engineering and of genetic resources and traditional knowledge ? This is combinatorial chemistry and one that uses standard proce - a controversial issue . Social protest in countries such as dures to extract aromatic oils . Otherwise , the policies may Mexico demands the need for a strong State intervention be unenforceable as they try to regulate access to millions not only in the negotiation of these benefits but also in all of local small firms that use , for example , plant material stages of implementation of bioprospecting projects ( see for the development of oils , infusions , and other common Chapter ï?? ) . Involving the Stateâ??s bureaucracy in the nego - remedies that can be developed rapidly with relatively tiation of benefit - sharing provisions may lead to inefficien - unsophisticated technology . cies and high transaction costs as suggested by Chapter ï?? . Access procedures for ex situ genetic resources remain Perhaps , State intervention in the negotiation of benefits a gray area in all countries due to ownership issues . For should be focused on an advisory and training role . For now , it seems that applications for ex situ collections in the example , countries such as Australia have proposed inde - countries examined in this section will be considered on pendent legal advice and training programs to improve the their own merits with respect to a range of factors . These negotiation capacity of local providers of genetic resources include the ownership of the material from which the ex and traditional knowledge . In addition to this , States could situ accessions were obtained and the circumstances under be more efficient by setting a minimum amount of royal - which the material passed into the possession of the ex situ ties and other benefit - sharing criteria ( see the section on holder , including possible terms and conditions proposed Benefit Sharing and Compensation Mechanisms ) for those by the holder ( i.e . , gene bank or botanical garden ) of the bioprospectors that are likely to obtain significant benefits ex situ genetic resources . For example , ex situ conservation from local genetic resources . centers such as the ones administered by ï쳌¦ ï쳌¡ ï쳌¯ have adopted While most countries require the ï쳌° ï쳌© ï쳌£ ( see next sec - ï쳌­ ï쳌´ ï쳌¡ s as a standard practice to exchange genetic resources tion ) from local communities , one country ( Thailand ) ( C . Qualset , pers . comm . January ï?? ï?? ï?? ï?? ) . does not require bioprospectors to obtain ï쳌° ï쳌© ï쳌£ from local communities , only from government officials . Evidently , Prior Informed Consent ( PIC ) obtaining the ï쳌° ï쳌© ï쳌£ from local communities increases not only the length of the access process but also transactions The ï쳌£ ï쳌¢ ï쳌¤ states that access to genetic resources should be costs . This has been the case in the Philippines ( see Chapter granted on mutually agreed terms and subject to ï쳌° ï쳌© ï쳌£ proce - ï?? ) . Additional access requirements of countries such as dures and this principle is endorsed by the laws and policies Thailand and Malaysia are also likely to increase the reviewed in this section . Under most regional and national length of application and transaction costs . However , since ï쳌¡ ï쳌¢ ï쳌³ laws and policies , in contrast to the ï쳌£ ï쳌¢ ï쳌¤ mandate , ï쳌° ï쳌© ï쳌£ national ï쳌¡ ï쳌¢ ï쳌³ policies of these and many other countries must be obtained not only from the designated govern - require a local collaborator to be involved in the different ment authorities but also from indigenous peoples and the steps of the research process , having a local counterpart landowners concerned . For this summary and analysis , ï쳌° ï쳌© ï쳌£ that is familiar with local costumes and bureaucracy may is defined as the consent obtained by the applicant from not only help expedite the access process , but also bring the designated government authorities , local community , legitimacy and transparency to the project . indigenous people , the protected area or ex situ collection Recently several scientists have argued that ï쳌¡ ï쳌¢ ï쳌³ poli - manager , or private land owner after disclosing fully the cies restrict noncommercial scientific research activities intent and scope of the bioprospecting activity , in a lan - such as taxonomic collections ( G ï쳌² ï쳌¡ ï쳌ª ï쳌¡ ï쳌¬ ï?? ï?? ï?? ï?? ) . Some guage and process understandable to all , and before any countries such as Costa Rica , Mexico , Nicaragua , and collecting of samples or knowledge is undertaken . the Philippines have been trying to differentiate between access for commercial and noncommercial purposes . The Australia : Draft EPBCAR line between commercial and noncommercial bioprospect - In Australia , aboriginal groups own significant areas ( ï?? ï?? % ing is still blurred ; however , these countries are taking steps of the Northern Territory and ï?? ï?? % of South Australia ) . in the right direction . Therefore , the regulations mandate the use of ï쳌° ï쳌© ï쳌£ in order Most national and regional ï쳌¡ ï쳌¢ ï쳌³ laws and policies regu - to get access to genetic resources and knowledge provided late access to biological , genetic , and biochemical com - by communities found in these areas . If the access provider ponents found in in situ conditions nationwide . The main is the owner of indigenous peoples â?? land or a native title ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ holder for the area , the access provider must have given interest of society and the second protects the interest of the owner of the land . ï쳌¥ ï쳌¥ ï쳌¥ ï쳌° ï쳌§ ï쳌¡ does not regulate access to informed consent to the agreement . Chapter ï?? lists key traditional knowledge , therefore it does not require any ï쳌° ï쳌© ï쳌£ issues that the Minister of the Environment and Heritage from the provider of traditional knowledge ( see Chapter must take into account to ensure that bioprospectors will ï?? ) . While Article ï?? ï?? of ï쳌· ï쳌§ ï쳌¡ requires only the ï쳌° ï쳌© ï쳌£ of the comply with ï쳌° ï쳌© ï쳌£ requirements . These include making sure owner of the land ( ï쳌³ ï쳌¥ ï쳌­ ï쳌¡ ï쳌² ï쳌® ï쳌¡ ï쳌´ ï?? ï?? ï?? ï?? ) , Articles ï?? ï?? ï?? and ï?? ï?? ï?? that the access provider had sufficient time to review the of ï쳌³ ï쳌¦ ï쳌¤ ï쳌§ ï쳌¡ require the ï쳌° ï쳌© ï쳌£ s from the owner of the property application and to consult with relevant people about the and from the indigenous community that provided tradi - pros and cons of the application . tional knowledge used for commercial and noncommercial Colombia , Ecuador , and Peru : Decision 391 purposes ( ï쳌³ ï쳌¥ ï쳌­ ï쳌¡ ï쳌² ï쳌® ï쳌¡ ï쳌´ ï?? ï?? ï?? ï?? ) . The draft ï쳌¬ ï쳌¡ ï쳌µ ï쳌¢ ï쳌§ ï쳌² includes Decision ï?? ï?? ï?? requires ï쳌° ï쳌© ï쳌£ from the pertinent government a ï쳌° ï쳌© ï쳌£ requirement from the government and providers of authority and the provider of genetic resources , their de - both genetic resources and traditional knowledge ( G ï쳌¡ ï쳌£ ï쳌¥ ï쳌´ ï쳌¡ rivatives , traditional knowledge , innovation , or practices . P ï쳌¡ ï쳌² ï쳌¬ ï쳌¡ ï쳌­ ï쳌¥ ï쳌® ï쳌´ ï쳌¡ ï쳌² ï쳌© ï쳌¡ ï?? ï?? ï?? ï?? ) . ï쳌° ï쳌© ï쳌£ from the providers of genetic resources or traditional Nicaragua : Draft Law of Biodiversity knowledge is provided to the government authority in the Bioprospectors are required to obtain the ï쳌° ï쳌© ï쳌£ of the pro - access application ( see previous section ) . When access to viders of traditional knowledge and the holders of the genetic resources includes access to traditional knowledge land where these resources are found . The consent has an annex contract signed by the provider of the knowledge to be clearly stated in a ï쳌° ï쳌© ï쳌£ contract established between will be integrated into the access contract . In certain cases , the bioprospector and provider of the genetic resource or however , ( subject to national legislation ) the national au - knowledge . The contract does not give exclusive use over thority may also sign the annex . In Peru , for example , Law the resource or knowledge . The provider is the rightful No . ï?? ï?? ï?? ï?? ï?? requires academic and commercial bioprospec - owner of the knowledge and has the right to establish tors to obtain the ï쳌° ï쳌© ï쳌£ from organizations that represent the contracts over the same component with other parties . interest of the community or communities that hold the The bioprospector cannot transfer the knowledge to other collective knowledge ( P ï쳌¥ ï쳌² ï쳌µ ï쳌¶ ï쳌© ï쳌¡ ï쳌® C ï쳌¯ ï쳌® ï쳌§ ï쳌² ï쳌¥ ï쳌³ ï쳌³ ï?? ï?? ï?? ï?? ) . parties without the prior consent of the community . This Costa Rica : The Law of Biodiversity contract will be effective once the access contract estab - The legislation is not clear , but it is assumed that the ï쳌° ï쳌© ï쳌£ lished between the government and the bioprospector is will be formalized in a private contract as described by signed ( ï쳌­ ï쳌¡ ï쳌² ï쳌¥ ï쳌® ï쳌¡ ï?? ï?? ï?? ï?? ) . The ï쳌° ï쳌© ï쳌£ requirement of the draft Law of Biodiversity is consistent withArticles ï?? ï?? and ï?? ï?? of the ï쳌§ ï쳌¡ ï쳌° . The role of the ï쳌´ ï쳌¯ is to endorse the contract . A ï쳌§ ï쳌¬ ï쳌¥ ï쳌® ï쳌² that protect the interests of the providers of genetic separate ï쳌° ï쳌© ï쳌£ will be obtained from individuals , government , resources and traditional knowledge ( ï쳌­ ï쳌¡ ï쳌² ï쳌¥ ï쳌® ï쳌¡ ï?? ï?? ï?? ï?? ) . or nongovernmental organizations that own lands or ma - rine resources and provide traditional knowledge . Access Philippines : EO 247 and Wildlife Act to flora and fauna found on private lands may also need According to ï쳌¥ ï쳌¯ ï?? ï?? ï?? and the Wildlife Act , bioprospecting authorizations from state entities , particularly in cases of activities , under a ï쳌£ ï쳌² ï쳌¡ , can be allowed only upon obtaining endangered species . In cases where collections are made the ï쳌° ï쳌© ï쳌£ of the community or individual that provides the in conservation areas , the ï쳌° ï쳌© ï쳌£ and the respective agreement genetic resource or the knowledge . Before conducting any are enough to obtain the access permit ( see Chapter ï?? ) . actual bioprospecting activity at the site , the researcher must obtain a ï쳌° ï쳌© ï쳌£ certificate . Bioprospecting is permit - Malaysia : ted in protected areas with the ï쳌° ï쳌© ï쳌£ of the Protected Area Draft federal bill on access to genetic resources Management Board ( ï쳌° ï쳌¡ ï쳌­ ï쳌¢ ) , in the lands of indigenous The pertinent authority shall establish an appropriate and local communities with their ï쳌° ï쳌© ï쳌£ , and on privately process for securing ï쳌° ï쳌© ï쳌£ of the resource provider that owned land with the ï쳌° ï쳌© ï쳌£ of the landowner . Under ï쳌¥ ï쳌¯ ï?? ï?? ï?? may be affected by the access application . The authority the provider of the ï쳌° ï쳌© ï쳌£ had to issue the certificate within shall prescribe the process after consultation with relevant ï?? ï?? days from the submission of the proposal . The Wildlife parties in order to ensure and verify that ï쳌° ï쳌© ï쳌£ is properly Act , however , removed this requirement . obtained . The consultation procedure must include at least Under ï쳌¥ ï쳌¯ ï?? ï?? ï?? , applicants for a ï쳌£ ï쳌² ï쳌¡ must complete the following requirements : a ) participation of represen - the following steps in order to secure a ï쳌° ï쳌© ï쳌£ certificate : a ) tatives of the indigenous and local communities and b ) submit copies of the research proposal to the head of the wide and effective dissemination of relevant information local community , city , or municipal mayor of the local to the providers of samples or traditional knowledge and government unit , ï쳌° ï쳌¡ ï쳌­ ï쳌¢ , or private landowner concerned other interested parties on the proposed access activity in a language or dialect understandable to them ; b ) inform ( see Chapter ï?? ï?? ) . the local community , ï쳌° ï쳌¡ ï쳌­ ï쳌¢ , or the private landowner con - Mexico : EEEPGA , WGA , SFDGA , and draft LAUBGR cerned of the intention to conduct bioprospecting within ï쳌¥ ï쳌¥ ï쳌¥ ï쳌° ï쳌§ ï쳌¡ requires two ï쳌° ï쳌© ï쳌£ s , one given by the Mexican the area through various media advertisements or direct Government in the form of a collecting permit and another communication ; c ) post a notice in a conspicuous place given by the owners of the land . The first ï쳌° ï쳌© ï쳌£ protects the one week prior to the holding of a community assembly ; ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : D ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¯ ï쳌¦ P ï쳌¯ ï쳌¬ ï쳌© ï쳌£ ï쳌© ï쳌¥ ï쳌³ ï쳌© ï쳌® P ï쳌¬ ï쳌¡ ï쳌£ ï쳌¥ ï쳌¡ ï쳌® ï쳌¤ ï쳌© ï쳌® P ï쳌² ï쳌¯ ï쳌§ ï쳌² ï쳌¥ ï쳌³ ï쳌³ d ) hold community consultation ; e ) obtain certificates of ï쳌° ï쳌¶ ï쳌° ï쳌¡ anyone who collects domestic plant varieties , wild plant varieties , or any part of such plant varieties for the compliance from the head of the local community , mu - purposes of variety development , education , experiment , nicipal or city mayor , ï쳌° ï쳌¡ ï쳌­ ï쳌¢ , or private landowner upon or research for commercial interest shall obtain permission determination that applicant has undergone the process from the competent official in the Ministry of Agriculture required by law ; and f ) submit ï쳌° ï쳌© ï쳌£ certificate to the ï쳌© ï쳌¡ ï쳌£ ï쳌¢ ï쳌§ ï쳌² ( T ï쳌¨ ï쳌¡ ï쳌© ï쳌¬ ï쳌¡ ï쳌® ï쳌¤ C ï쳌¯ ï쳌® ï쳌§ ï쳌² ï쳌¥ ï쳌³ ï쳌³ ï?? ï?? ï?? ï?? ) . Under ï쳌² ï쳌¦ ï쳌³ ï쳌² ï쳌£ ï쳌¦ ï쳌¡ and ï쳌¡ ï쳌° ï쳌° ï쳌´ ï쳌­ ï쳌© , together with proofs of compliance with the ï쳌° ï쳌© ï쳌£ process . bioprospectors obtain ï쳌° ï쳌© ï쳌£ from government officials by The research proposal presented to the provider of the applying to the ï쳌² ï쳌¦ ï쳌¤ and Ministry of Public Health respec - genetic resource or traditional knowledge must include the tively ( C . Hutacharern , pers . comm . June ï?? ï?? ï?? ï?? ) . It should purpose , methodology , duration of the activity ; designate be emphasized that the ï쳌° ï쳌¶ ï쳌° ï쳌¡ , ï쳌² ï쳌¦ ï쳌³ ï쳌² ï쳌£ ï쳌¦ ï쳌¡ , and ï쳌¡ ï쳌° ï쳌° ï쳌´ ï쳌­ ï쳌© do not the species and quantity to be used or taken ; describe the require bioprospectors to obtain ï쳌° ï쳌© ï쳌£ from communities proposal for equitable sharing of benefits , if any , to all par - living in collection areas ties concerned ; and state that the proposed activity will not affect traditional uses of the resource ( see Chapter ï?? ) . USA : NPS research specimen collection permit This procedure was slightly altered by the ï?? ï?? ï?? ï?? draft The ï쳌° ï쳌© ï쳌£ is implemented through the detailed permit ap - Guidelines for Bioprospecting Activities that will imple - plication and approval process now instituted throughout ment the Wildlife Act if approved . The necessary steps the ï쳌® ï쳌° ï쳌³ ( see previous section and Chapter ï?? ) . include notification through a letter of intent ( including research proposal ) to the resource providers and the holding Analysis : PIC of a community assembly at which the proposal is presented As interpreted from the ï쳌£ ï쳌¢ ï쳌¤ , bioprospectors must obtain giving a very detailed description of the activity and assur - ï쳌° ï쳌© ï쳌£ and this is incorporated in the policies and laws for ances that traditional uses or consumption of the resource all the countries reviewed in this section . Procedures will not be affected . The next steps depend on the issuer of for obtaining ï쳌° ï쳌© ï쳌£ in these countries are usually initiated the ï쳌° ï쳌© ï쳌£ : for the ï쳌° ï쳌¡ ï쳌­ ï쳌¢ , the chair will sign the ï쳌° ï쳌© ï쳌£ certificate when the access application is submitted to the designated upon authority granted through an appropriate Resolution government authorities ( see previous section ) . ï쳌¡ ï쳌¢ ï쳌³ poli - passed within ï?? ï?? days after the consultation favorably grant - cies of these countries , except for Thailand and the ï쳌µ ï쳌³ ï쳌¡ , ing such consent ; the private landowner , or other concerned also require ï쳌° ï쳌© ï쳌£ from the providers of genetic resources agencies , must issue the ï쳌° ï쳌© ï쳌£ certificate within ï?? ï?? days after and traditional knowledge . However , information about the consultation ; and in the case of indigenous peoples , how to obtain ï쳌° ï쳌© ï쳌£ from traditional communities remains the issuance of the ï쳌° ï쳌© ï쳌£ certificate is governed by pertinent unclear in all countries except for the Philippines ( ï쳌¥ ï쳌¯ ï?? ï?? ï?? rules and regulations under the RepublicAct No . ï?? ï?? ï?? ï?? also and Wildlife Act ) and Peru ( Law No . ï?? ï?? ï?? ï?? ï?? ) . Thailand is known as the Indigenous Peoples â?? Rights Act . Access to the only country that requires foreign bioprospectors to traditional knowledge must be explicitly reflected in the cer - obtain ï쳌° ï쳌© ï쳌£ twice from government authorities . The first tificate . The guidelines provide a standard ï쳌° ï쳌© ï쳌£ form . Under one is obtained prior to entering the country through the the WildlifeAct , collectors and users of biological resources letter of permission required for the visa . The second for noncommercial purposes will also have to obtain ï쳌° ï쳌© ï쳌£ one is obtained through the application process made to from the providers of these resources . No ï쳌° ï쳌© ï쳌£ procedure has the agency that administers the resource that will be ac - been officially adopted yet for this kind of collections , but cessed . Unlike the other countries , the ï쳌µ ï쳌³ ï쳌¡ does not have it is likely to involve fewer steps and requirements than the a designated government authority regulating access to one proposed for collectors that have commercial purposes genetic resources that provides the ï쳌° ï쳌© ï쳌£ of the State . In ( P . Benavidez , pers . comm . February ï?? ï?? ï?? ï?? ) . the specific case of the ï쳌® ï쳌° ï쳌³ lands , bioprospectors have to obtain the consent from the ï쳌® ï쳌° ï쳌³ and such consent , which Samoa : CABSSBR is analogous to the ï쳌° ï쳌© ï쳌£ , is obtained through the permit ï쳌° ï쳌© ï쳌£ is obtained from the government when the access application of the ï쳌® ï쳌° ï쳌³ . application is submitted to the Division of Environment Despite the fact that ï쳌° ï쳌© ï쳌£ requirements are likely to be and Conservation of the Department of Lands , Surveys , expensive and cumbersome to obtain for many bioprospec - and Environment ( ï쳌¤ ï쳌¬ ï쳌³ ï쳌¥ ï?? ï?? ï?? ï?? ) . A final decision on the ap - tors , the motive for the requirement is twofold : a ) ï쳌° ï쳌© ï쳌£ is a plication is made by the Minister of Lands , Surveys , and direct consequence of countries being sovereign to deter - Environment who can require the applicant to provide mine whether or not to grant access to their genetic resour - evidence of the prior informed consent of the resource ces and b ) ï쳌° ï쳌© ï쳌£ will help to ensure that benefits are shared owner ( or person in effective control of the resources ) . equitably , give transparency to bioprospecting projects , Bioprospecting activities carried out in private or custom - and contribute to their success . However , bioprospectors ary land ( ï?? ï?? % of the land area of the country ) will require are likely to run into difficulties and challenges while try - ï쳌° ï쳌© ï쳌£ from the landowners . ing to obtain ï쳌° ï쳌© ï쳌£ from local communities and government Thailand : PVPA , RFSRCFA , and APPTMI agencies . These include : a ) identifying the representatives Foreign bioprospectors must obtain initial ï쳌° ï쳌© ï쳌£ from a of the communities and assessing their representation designated government authority ( i.e . , ï쳌® ï쳌² ï쳌£ ï쳌´ ) through the power and capacity ; b ) identifying all the parties affected permission letter that is required to obtain a visa . Under by the project ; c ) presenting the bioprospecting project , ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ legal concepts ( ï쳌© ï쳌° ï쳌² s , property , etc . ) , and benefits for the cess ; b ) promotion of the participation of local scientists community in a form and manner understandable to the in order to enhance local scientific , technical , and techno - target group ; d ) identifying and presenting the implications logical capacities ; and c ) strengthening of mechanisms to of the project for the community ; e ) identifying communi - transfer knowledge and technologies including environ - ties who share the same knowledge ; and f ) obtaining the mentally sound biotechnologies . Bioprospectors are also ï쳌° ï쳌© ï쳌£ from several local and national government agencies obliged to deposit duplicates of samples collected in sites that administer the same biological resource . In any case , designated by the pertinent national authority ( A ï쳌® ï쳌¤ ï쳌¥ ï쳌¡ ï쳌® bioprospectors have to keep in mind that traditional com - C ï쳌¯ ï쳌­ ï쳌­ ï쳌µ ï쳌® ï쳌© ï쳌´ ï쳌¹ ï?? ï?? ï?? ï?? ) . munities and governments may choose to deny access ( see Under Decision ï?? ï?? ï?? , the national authority may also Chapters ï?? , ï?? , and ï?? ) and this is a legitimate decision based establish framework access contracts for projects carried on the national sovereignty recognized by the ï쳌£ ï쳌¢ ï쳌¤ and the out by universities , research centers , or researchers for ï쳌¡ ï쳌¢ ï쳌³ laws and policies described above . noncommercial purposes . Details about requirements for this type of contracts are defined according to local legis - lation . For example , the draft of the Peruvian regulation Benefit Sharing and on genetic resources states that universities and academic Compensation Mechanisms research centers ( based in Peru ) may use a framework ac - 24 Biodiversity conservation and sustainable use , research cess contract to access genetic resources as long as they and training opportunities , public education and aware - comply with the following requirements : a ) participation ness , transfer of technology , exchange of information , of national professionals in collecting and research activi - and technical and scientific cooperation are some of the ties ; b ) indication by the research program of proposed key goals of the ï쳌£ ï쳌¢ ï쳌¤ that may become operational in the methodologies for the collection of samples ; c ) commit - context of bioprospecting projects . These are also some ment to inform local authorities about research advances , of the benefits that are usually negotiated in access and results , and publications generated from access activities ; 23 benefit - sharing contracts . Contracts formalize this rela - d ) plan to restrict the transfer of samples to third parties ; tionship and attempt to ensure that pharmaceutical , seed , e ) provisions about potential ï쳌© ï쳌° ï쳌² s on products or processes agricultural , biotechnology and other companies compen - derived from the use of genetic resources and their de - sate researchers , collectors , and collaborators from coun - rivatives ; f ) background information about the situation tries with great biological , genetic , and cultural diversity . of the genetic resources , their derivatives , and associated Trust funds have also been proposed as a mechanism to knowledge that are being accessed ; g ) information about facilitate the equitable distribution of benefits . access risks , including uses and value of the resource ; h ) provisions about collection and sample payments ; and i ) Australia : Draft EPBCAR deposition of duplicates of collected samples in organiza - Benefit - sharing agreements must be negotiated at the tions identified by the national authority ( these organiza - beginning of a project , rather than after a lead has been tions may loan these duplicates to foreign partners only identified . In ï?? ï?? ï?? ï?? or ï?? ï?? ï?? ï?? , the Minister is likely to pres - for taxonomy studies ) ( ï쳌© ï쳌® ï쳌² ï쳌¥ ï쳌® ï쳌¡ ï?? ï?? ï?? ï?? ) . ent a model benefit - sharing agreement , but its use by Decision ï?? ï?? ï?? recognizes the rights and decision - mak - bioprospectors will not be mandatory . These agreements ing capacity of indigenous , black , and local communities must provide for reasonable monetary and nonmonetary with regards to their traditional knowledge , practices , and benefit - sharing arrangements covering matters such as up - innovations connected with genetic resources and their front payments for samples , royalties , milestone payments , derivatives ( A ï쳌® ï쳌¤ ï쳌¥ ï쳌¡ ï쳌® C ï쳌¯ ï쳌­ ï쳌­ ï쳌µ ï쳌® ï쳌© ï쳌´ ï쳌¹ ï?? ï?? ï?? ï?? ) . Under Peruâ??s and participation ofAustralians in research activities . They Law No . ï?? ï?? ï?? ï?? ï?? commercial bioprospectors have to sign must also recognize and value any indigenous knowledge an annex contract or license that provides at least the given by the access provider . A trust fund has also been following benefit - sharing obligations : a ) an up - front pay - proposed to facilitate the compensation of indigenous ment or its equivalent that contributes to the sustainable knowledge , but no decisions have been made so far to development of indigenous communities ; b ) royalties no facilitate its development . The regulations also state that less than ï?? % of the gross sale of products ( before taxes ) an agreement may be both a benefit - sharing agreement derived from the use of collective knowledge accessed and an indigenous land - use agreement under the Native by the bioprospector ; and c ) the strengthening of local Title Act ( see Chapter ï?? ) . capacities of indigenous communities in relation to their collective knowledge associated with biological diversity Colombia , Ecuador , and Peru : Decision 391 ( P ï쳌¥ ï쳌² ï쳌µ ï쳌¶ ï쳌© ï쳌¡ ï쳌® C ï쳌¯ ï쳌® ï쳌§ ï쳌² ï쳌¥ ï쳌³ ï쳌³ ï?? ï?? ï?? ï?? ) . Commercial and noncommercial bioprospectors have to Decision ï?? ï?? ï?? states that the member countries shall negotiate an access agreement with the government and set up trust funds or other financial mechanisms to distrib - an accessory or annex agreement with the providers of the ute the benefits derived from bioprospecting initiatives . genetic resource or the traditional knowledge respectively . Neither Colombia , Ecuador , nor Peru has so far received These agreements have to address at least the following economic benefits that can be channeled to a trust fund . benefit - sharing issues : a ) establishment of conditions for a just and equitable sharing of benefits generated from ac - Peruâ??s Law No . ï?? ï?? ï?? ï?? ï?? , however , creates a trust fund for the ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : D ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¯ ï쳌¦ P ï쳌¯ ï쳌¬ ï쳌© ï쳌£ ï쳌© ï쳌¥ ï쳌³ ï쳌© ï쳌® P ï쳌¬ ï쳌¡ ï쳌£ ï쳌¥ ï쳌¡ ï쳌® ï쳌¤ ï쳌© ï쳌® P ï쳌² ï쳌¯ ï쳌§ ï쳌² ï쳌¥ ï쳌³ ï쳌³ development of indigenous peoples . No less than ï?? ï?? % of of rural communities . Furthermore , these activities must encourage the equitable distribution of benefits derived the gross sales ( before taxes ) of products derived from the from the use of such knowledge . Under Article ï?? ï?? ï?? of collective knowledge will go to the trust fund ( P ï쳌¥ ï쳌² ï쳌µ ï쳌¶ ï쳌© ï쳌¡ ï쳌® ï쳌³ ï쳌¦ ï쳌¤ ï쳌§ ï쳌¡ bioprospectors that use traditional knowledge must C ï쳌¯ ï쳌® ï쳌§ ï쳌² ï쳌¥ ï쳌³ ï쳌³ ï?? ï?? ï?? ï?? ) . sign a ï쳌° ï쳌© ï쳌£ agreement with the indigenous community that Costa Rica : The Law of Biodiversity provided the knowledge . It is not clear whether this is also This law regulates the equitable distribution of benefits a benefit - sharing agreement , however , according to ï쳌³ ï쳌¦ ï쳌¤ ï쳌§ ï쳌¡ and the protection of traditional knowledge . In addition this agreement must acknowledge the property rights of the to monetary and nonmonetary benefits negotiated among community over its knowledge ( ï쳌³ ï쳌¥ ï쳌­ ï쳌¡ ï쳌² ï쳌® ï쳌¡ ï쳌´ ï?? ï?? ï?? ï?? ) . the parties to a bioprospecting initiative , the Law of Under the draft ï쳌¬ ï쳌¡ ï쳌µ ï쳌¢ ï쳌§ ï쳌² bioprospectors have to negoti - Biodiversity mandates bioprospectors to pay ï?? ï?? % of the ate an access and benefit - sharing contract with ï쳌³ ï쳌¥ ï쳌­ ï쳌¡ ï쳌² ï쳌® ï쳌¡ ï쳌´ research budget and ï?? ï?? % of the royalties to the National and the provider of the genetic resource and traditional System of Protected Areas , the indigenous representative , knowledge . ï쳌³ ï쳌¥ ï쳌­ ï쳌¡ ï쳌² ï쳌® ï쳌¡ ï쳌´ can also negotiate access contracts or the landholder that provided the genetic , biological , or with national universities and research centers . In any case , biochemical resources ( see Chapter ï?? ) . the access contract should include the conditions for the fair and equitable distribution of benefits derived from the Malaysia : commercialization of products derived from local genetic Draft federal bill on access to genetic resources resources and traditional knowledge . It should also include The draft bill regulates the sharing of benefits derived from the type of protection given to traditional knowledge . The the use of genetic resources and traditional knowledge . protection of technologies derived from access activities In determining the nature and combination of benefits will be shared by the parties and adjusted for ï쳌© ï쳌° ï쳌² protection from access to either biological resources or traditional ( G ï쳌¡ ï쳌£ ï쳌¥ ï쳌´ ï쳌¡ P ï쳌¡ ï쳌² ï쳌¬ ï쳌¡ ï쳌­ ï쳌¥ ï쳌® ï쳌´ ï쳌¡ ï쳌² ï쳌© ï쳌¡ ï?? ï?? ï?? ï?? ) . knowledge , the pertinent authority shall take into account relevant factors that include : a ) the conservation status of Nicaragua : Draft Law of Biodiversity the biological resource ; b ) endemism or rarity of the bio - The main access contract that bioprospectors have to ne - logical resource ; c ) the existing , potential , intrinsic , and gotiate with the government has to include an accessory commercial value of the resource ; d ) the proposed use of contract that provides details about benefits negotiated the resource ; and e ) whether traditional knowledge is in - with the providers of the genetic resources and indigenous volved . In any case , since local organizations must be part knowledge . The ï쳌° ï쳌© ï쳌£ contract described in the previous sec - of any bioprospecting venture , monetary or nonmonetary tion is also used to protect and compensate indigenous benefits are likely to be received by these entities . knowledge and it includes the following requirements : a ) Furthermore , a provision of the bill proposes the es - identification of the parties ; b ) description of the collective tablishment of a common trust fund to channel benefits knowledge that will be transferred ; c ) plans for up - front derived from the use of traditional knowledge . Therefore , payment and a payment of a percentage of the net sales of bioprospectors will have to pay to the fund a percentage products marketed as a result of the knowledge provided ; of the gross sales of any product or process utilizing or d ) the obligation to inform the provider about the objec - incorporating the traditional knowledge . The competent tives , risks , or implications derived from the use of the authority and the indigenous or local community will be collective knowledge ; and e ) the obligation to inform the jointly responsible for the equitable distribution of the parties about progress in the research , industrialization , monies solely for the benefit of the concerned indigenous and marketing of products derived from the knowledge or local community . The payment made to the fund will provided ( ï쳌­ ï쳌¡ ï쳌² ï쳌¥ ï쳌® ï쳌¡ ï?? ï?? ï?? ï?? ) . be administered by the national competent authority to Philippines : EO 247 and Wildlife Act promote the wellbeing of the indigenous and local com - ï쳌¥ ï쳌¯ ï?? ï?? ï?? provides an ï쳌¡ ï쳌² ï쳌¡ or ï쳌£ ï쳌² ï쳌¡ to facilitate the sharing munities and for the conservation and sustainable use of of monetary and nonmonetary benefits . The Wildlife Act , the biological resources ( see Chapter ï?? ï?? ) . however , does not require an ï쳌¡ ï쳌² ï쳌¡ any longer . The ï쳌¡ ï쳌² ï쳌¡ Mexico : EEEPGA , WGA , SFDGA , and draft LAUBGR was intended primarily for academic purposes , so benefits Article ï?? ï?? ï쳌¢ ï쳌© ï쳌³ of the ï쳌¥ ï쳌¥ ï쳌¥ ï쳌° ï쳌§ ï쳌¡ states that owners of genetic shared included opportunities to publish research , access to or biological resources are entitled to receive a share of information , and academic training . An ï쳌¡ ï쳌² ï쳌¡ was valid for benefits derived from the use of these resources . Mexicoâ??s a period of five years , renewable upon recommendation of ï쳌¥ ï쳌¥ ï쳌¥ ï쳌° ï쳌§ ï쳌¡ does not regulate access to traditional knowledge the ï쳌© ï쳌¡ ï쳌£ ï쳌¢ ï쳌§ ï쳌² . Research intended for commercial use require associated with genetic resources , but it recognizes the a ï쳌£ ï쳌² ï쳌¡ that is valid for a period of three years and renewable need to protect and disseminate the knowledge of indige - for a period as may be determined by the ï쳌© ï쳌¡ ï쳌£ ï쳌¢ ï쳌§ ï쳌² . nous communities in order to promote the conservation and Although the introductory clause of ï쳌¥ ï쳌¯ ï?? ï?? ï?? mentions sustainable use of biodiversity ( see Chapter ï?? ) . Similarly , traditional knowledge , nowhere in the text of the law has Article ï?? ï?? of ï쳌· ï쳌§ ï쳌¡ states that conservation and sustain - it been discussed . However , traditional knowledge of local able use activities of wildlife resources must ensure the and indigenous communities is linked with the ï쳌° ï쳌© ï쳌£ of the protection of traditional knowledge and the participation communities where the resources are taken . ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ Under ï쳌¥ ï쳌¯ ï?? ï?? ï?? benefit sharing is required at two stages : the bioprospector . at the time of collection and at the time of commercializa - The second benefit - sharing model applies to collectors tion . At the time of collection , the minimum benefits that of general domestic plant varieties , wild plant varieties , must be obtained are explicitly provided for in ï쳌¥ ï쳌¯ ï?? ï?? ï?? , or any part of such plant varieties for the purposes of va - while benefit sharing at the time of commercialization is riety development , education , experiment , or research for not expressly required . The parties , however , are free to commercial interest . In this case the profits derived from negotiate any kind of monetary and nonmonetary benefits any benefit - sharing agreement must be paid to the Plant ( see Chapter ï?? ) . Varieties Protection Fund . The main objective of this fund However , the ï?? ï?? ï?? ï?? draft Guidelines for Bioprospecting will be to promote the conservation , research , and devel - Activities would repeal the benefits - sharing provisions opment activities of plant varieties of local communities of ï쳌¥ ï쳌¯ ï?? ï?? ï?? and require bioprospectors to apply for a ( T ï쳌¨ ï쳌¡ ï쳌© ï쳌¬ ï쳌¡ ï쳌® ï쳌¤ C ï쳌¯ ï쳌® ï쳌§ ï쳌² ï쳌¥ ï쳌³ ï쳌³ ï?? ï?? ï?? ï?? ) . Bioprospecting Undertaking instead of a ï쳌£ ï쳌² ï쳌¡ . Under the Under ï쳌² ï쳌¦ ï쳌³ ï쳌² ï쳌£ ï쳌¦ ï쳌¡ , commercial bioprospecting projects guidelines , in addition to the fees discussed above in the have to establish a benefit - sharing agreement with the ï쳌² ï쳌¦ ï쳌¤ Access Procedure section , applicants would have to be that includes a payment of royalties on all inventions de - prepared to pay a minimum amount of ï?? % of the gross rived from genetic resources . This agreement may include sales of products made or derived from collected samples . other forms of monetary and nonmonetary compensation In addition , the applicant would have to provide minimum strategies . The agreement must also state that Thai scien - nonmonetary benefits such as equipment for biodiversity tists will be involved in all collection and research activi - inventory and monitoring , supplies and equipment for ties.All Thai citizens and governmental organizations must resource conservation acitivities ; arrangements for tech - have access to collected specimens and relevant data for nology transfer ; formal training and educational facilities , research and studies . A duplicate of specimens collected infrastructure directly related to management of the collec - must also be deposited at the Royal Forest Department tion area ; health care costs for persons involved ; and other ( C ï쳌¨ ï쳌¡ ï쳌¬ ï쳌¥ ï쳌² ï쳌­ ï쳌° ï쳌¯ ï쳌® ï쳌§ ï쳌³ ï쳌¥ ï?? ï?? ï?? ï?? ) . ï쳌¡ ï쳌° ï쳌° ï쳌´ ï쳌­ ï쳌© states that users of capacity building and support for in situ conservation and traditional knowledge about medicines must submit an development activities . The guidelines include a model application to the licensing authority at Ministry of Public checklist of indicators ( Annex î?µ ) for monitoring whether Health in order to initiate the negotiation process of poten - the benefit - sharing agreement is fair and equitable ( see tial benefits derived from such a use ( ï쳌® ï쳌© ï쳌´ ï쳌´ ï쳌­ ï?? ï?? ï?? ï?? ) . endnote ï?? ï?? for access to the guidelines ) . USA : NPS research specimen collection permit Samoa : CABSSBR The ï?? ï?? ï?? ï?? Federal Technology Transfer Act was invoked The conditions state that a benefit - sharing agreement has to to develop a Cooperative Research and Development 28 be signed between the bioprospector and the government Agreement ( ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ ) that facilitated the distribution of of Samoa . This agreement has to acknowledge all relevant benefits derived from the use of biological samples col - traditional knowledge and practice that will be used by the lected inYellowstone National Park . The term of the ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ bioprospectors . The conditions also state that the minimum was for an initial five - year period , but it provided that the royalty is ï?? % . However , it is not clear whether this is ï?? % benefit - sharing obligations survived termination which is of the net or gross sale of final products derived directly very important since development of valuable discoveries from collected samples or inspired by the chemistry of can take more than ten years to achieve ( see Chapter ï?? ) . these samples . Bioprospectors also have to negotiate a Analysis : legally binding agreement with the providers of biological Benefit Sharing and Compensation Mechanisms resources . This agreement must include royalties , fees , Contracts are the heart of bioprospecting initiatives . They and other payments for access to genetic resources and are the main mechanism used by countries to ensure that traditional knowledge ( ï쳌¤ ï쳌¬ ï쳌³ ï쳌¥ ï?? ï?? ï?? ï?? ) . monetary and nonmonetary benefits are negotiated under Thailand : PVPA , RFSRCFA , and APPTMI mutually agreed terms . Monetary and nonmonetary ben - ï쳌° ï쳌¶ ï쳌° ï쳌¡ provides for two benefit - sharing models for com - efits have been thoroughly identified by the literature and 25 26 mercial users of local domestic , general domestic , include royalties , up - front payments , milestone payments , 27 and wild plant varieties . The first model applies to any research funding , license fees , salaries and infrastructure , bioprospector who collects or procures a local domestic sharing of research results , biodiversity conservation , plant variety or any part thereof for the purposes of vari - training , participation of nationals on research activities , ety development , education , experiment , or research for technology transfer , and recovery of traditional knowledge . commercial purposes . If this is the case , the distribution These and many other benefits should be negotiated on a of benefits derived from this activity is as follows : Twenty case - by - case basis among parties directly involved in the percent of the profits shall be allocated to the persons projects . In some cases these parties must follow minimum who conserved or developed the plant variety , ï?? ï?? % to benefit - sharing criteria . For example , Costa Rica , Peru , the community as its common revenue , and ï?? ï?? % to the the Philippines , and Samoa have chosen to set a baseline local government organization , the farmerâ??s group , or the or criteria for the benefits that they expect to receive . cooperative that signs the benefit - sharing agreement with Samoa , for example , demands a minimum ï?? % royalty ( no ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : D ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¯ ï쳌¦ P ï쳌¯ ï쳌¬ ï쳌© ï쳌£ ï쳌© ï쳌¥ ï쳌³ ï쳌© ï쳌® P ï쳌¬ ï쳌¡ ï쳌£ ï쳌¥ ï쳌¡ ï쳌® ï쳌¤ ï쳌© ï쳌® P ï쳌² ï쳌¯ ï쳌§ ï쳌² ï쳌¥ ï쳌³ ï쳌³ information is provided about whether this is taken from Under the ï쳌£ ï쳌¢ ï쳌¤ , Parties are not obliged to have a patent net or gross sales of products ) . Furthermore , Malaysiaâ??s system for the protection of inventions derived from bio - draft bill proposes to use a set of criteria to identify the logical diversity and traditional knowledge . However , un - nature and combination of benefits . Unfortunately , most der theAgreement on Trade - RelatedAspects of Intellectual countries seem to be focused on the negotiation of royal - Property Rights ( ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ ) , member countries have to provide ties that might never materialize and they tend to give less patent protection for microorganisms ( as products ) and importance to nonmonetary benefits that might contribute for nonbiological and microbiological processes used for to build local capacity . the production of plants and animals . The scope of patent These benefit - sharing criteria , however , are merely a protection does not have to include plants and animals . starting point . Whether agreements are fair and equitable But , plant breeders â?? rights or another sui generis system is a subjective issue that lies in the eye of the beholder must protect plant varieties . Furthermore under ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ , the ( or the negotiator ) . The fairness of contracts depends in World Trade Organization ( ï쳌· ï쳌´ ï쳌¯ ) can enforce minimum large part on the skills of the parties to negotiate adequate standards for all ï쳌© ï쳌° ï쳌² s . benefit - sharing and compensation provisions . In the past , Sixty percent of the ï?? ï?? Pacific Rim countries examined negotiators from developing countries may not have been in this report are ï쳌· ï쳌´ ï쳌¯ members and have complied or are as qualified as their counterparts from industrialized in the process of complying with ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ requirements , ï?? ï?? % countries , but this is changing . The actors involved in the are ï쳌· ï쳌´ ï쳌¯ observers , and the remaining ï?? ï?? % of countries do business of bioprospecting have increased in diversity and not fall in any of the above categories . Countries within number . Information about the rights and obligations of this last ï?? ï?? % include Kiribati , Niue , and Solomon Islands bioprospecting parties and their collaborators has prolif - which are planning to develop ï쳌© ï쳌° ï쳌² laws and may apply for erated and it is reaching scientists and indigenous groups ï쳌· ï쳌´ ï쳌¯ membership in the future . In addition , they rely on from developing countries . In any case , bioprospectors ï쳌© ï쳌° ï쳌² legislation of developed countries such as the United should keep in mind that a fair and equitable sharing of Kingdom and New Zealand with which they have post - benefits derived from access activities is one of the three colonial and economic ties ( see Table ï?? ) . objectives of the ï쳌£ ï쳌¢ ï쳌¤ and a requirement of ï쳌¡ ï쳌¢ ï쳌³ . Article Australia : Draft EPBCAR ï?? ï?? ( ï?? ) of the ï쳌£ ï쳌¢ ï쳌¤ specifically refers to the aim of sharing Australiaâ??s patent law allows for the patenting of plants , the results of research and development â?쳌 as well as the microorganisms , genes , and related biological materi - â?? benefits arising from the commercialization and other als , provided that these meet the countryâ??s standards of 29 utilization of genetic resources â?쳌 . 31 proof for patentability . Plant variety protection is also Contracts in combination with ï쳌° ï쳌© ï쳌£ requirements have provided by plant breeders â?? rights . Therefore , Australia also been proposed to protect and recognize indigenous complies with the relevant ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ provisions . However , the knowledge in monetary and nonmonetary terms . ï쳌¡ ï쳌¢ ï쳌³ laws countryâ??s intellectual property regime does not currently and policies of most countries propose access , annex , and protect indigenous knowledge . On the other hand , it should accessory contracts to this purpose . In addition to this , most be noted that the Nationally Consistent Approach states countries have endorsed trust funds as a useful mechanism that legislative , administrative , or policy frameworks in to distribute benefits among several communities that share Australian jurisdictions shall â?? recognize the need to ensure the knowledge used by bioprospectors . However , there is the use of traditional knowledge is undertaken with the little experience and information on the practical operation cooperation and approval of the holders of that knowledge of these trust funds and therefore on their usefulness . and on mutually agreed terms â?쳌 ( see Chapter ï?? ) . This may be a narrower principle than that which indigenous people IPRs and the Protection appear to be asserting in Australia ( see Chapter ï?? ) . The of Traditional Knowledge fact that the debate continues , however , suggests that there Article ï?? ï?? ( ï?? ) of the ï쳌£ ï쳌¢ ï쳌¤ recognizes the potential influence may be a need for a more rigorous attempt to identify the of patents and other ï쳌© ï쳌° ï쳌² s on the implementation of the issues and to develop acceptable solutions . Convention and called on Contracting Parties to ensure The draft regulations do not refer specifically to ï쳌© ï쳌° ï쳌² that â?? such rights are supportive of and do not run counter protection of inventions derived from genetic resources 30 to its objectives â?쳌 . This statement reflects uncertainty and or indigenous knowledge . They do , however , include disagreement about the impact of patents and ï쳌© ï쳌° ï쳌² s on the provisions requiring prior informed consent and adequate ï쳌£ ï쳌¢ ï쳌¤ objectives . This was probably due to the different valuing of indigenous knowledge in the benefit - sharing political positions on this controversial issue during the contract . V ï쳌¯ ï쳌µ ï쳌­ ï쳌¡ ï쳌² ï쳌¤ ( ï?? ï?? ï?? ï?? ) also recommended that pat - negotiations of the ï쳌£ ï쳌¢ ï쳌¤ and the lack of agreement on the ent law should be amended in order to include proof of impacts of patents and other ï쳌© ï쳌° ï쳌² s on biodiversity which source and , where appropriate , prior informed consent , as led to such a broadly and ambiguous text . Even today a prerequisite for granting a patent . there is great disagreement about the impacts of ï쳌© ï쳌° ï쳌² s on Colombia , Ecuador , and Peru : Decision 391 biodiversity and traditional knowledge ( C ï쳌¯ ï쳌² ï쳌² ï쳌¥ ï쳌¡ ï?? ï?? ï?? ï?? , Decision ï?? ï?? ï?? includes key provisions about ï쳌© ï쳌° ï쳌² s that D ï쳌µ ï쳌´ ï쳌¦ ï쳌© ï쳌¥ ï쳌¬ ï쳌¤ ï?? ï?? ï?? ï?? , S ï쳌¨ ï쳌© ï쳌¶ ï쳌¡ ï?? ï?? ï?? ï?? , see Chapters ï?? and ï?? ) and the issue will not be settled in the near future . are strengthened by Decision ï?? ï?? ï?? , the Common Regime ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ on Industrial Property that was approved by the Andean C ï쳌¯ ï쳌® ï쳌§ ï쳌² ï쳌¥ ï쳌³ ï쳌³ ï?? ï?? ï?? ï?? ) . Community in ï?? ï?? ï?? ï?? . Decision ï?? ï?? ï?? states that member On the other hand it should be noted that Decision ï?? ï?? ï?? countries will not recognize intellectual property rights will provide intellectual property protection as long as over genetic resources , derivatives , synthesized products , applicants prove that they complied with regulations that or related intangible components that have been obtained protect the genetic resources and knowledge of indigenous through access activities which do not comply with the peoples and other local communities . Decision ï?? ï?? ï?? also provisions of the Decision . According to Decision ï?? ï?? ï?? na - complies with ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ . It protects microorganisms but it tional intellectual property offices shall require applicants does not provide protection to plants , animals , sequences to submit the registration number of the access contract of genes ( that have been isolated ) , and essentially bio - and a copy of it as a prerequisite for the granting of the logical procedures for the production of plants or animals . ï쳌© ï쳌° ï쳌² when there is reasonable evidence to suggest that the Decision ï?? ï?? ï?? also includes a compulsory licensing provi - products or processes for which an ï쳌© ï쳌° ï쳌² is being sought sion that allows member states the free use of any invention have been obtained from genetic resources of an Andean derived from biological resources in a situation of national Member Country ( A ï쳌® ï쳌¤ ï쳌¥ ï쳌¡ ï쳌® C ï쳌¯ ï쳌­ ï쳌­ ï쳌µ ï쳌® ï쳌© ï쳌´ ï쳌¹ ï?? ï?? ï?? ï?? ) . Decision emergency ( A ï쳌® ï쳌¤ ï쳌¥ ï쳌¡ ï쳌® C ï쳌¯ ï쳌­ ï쳌­ ï쳌µ ï쳌® ï쳌© ï쳌´ ï쳌¹ ï?? ï?? ï?? ï?? ) . ï?? ï?? ï?? supports Decision ï?? ï?? ï?? by requiring patent applicants Plant variety protection is provided by Decision ï?? ï?? ï?? , to include a copy of the access contract , when products the Common Regime for the Protection of the Rights of or procedures have been obtained or developed based on Breeders of Plant Varieties , that establishes a sui generis genetic resources from any of the members of the Andean property rights regime regulating plant breeders â?? rights , Community ( A ï쳌® ï쳌¤ ï쳌¥ ï쳌¡ ï쳌® C ï쳌¯ ï쳌­ ï쳌­ ï쳌µ ï쳌® ï쳌© ï쳌´ ï쳌¹ ï?? ï?? ï?? ï?? ) . thus protecting farmers and regulating ownership of newly Decisions ï?? ï?? ï?? and ï?? ï?? ï?? also address the need to pro - developed plant varieties . The regime complies with the tect traditional knowledge.According to Decision ï?? ï?? ï?? , the provisions of the International Union for the Protection of Andean Community will prepare a proposal for a special New Varieties of Plants ( ï쳌µ ï쳌° ï쳌¯ ï쳌¶ ) ( see Chapter ï?? ) . regime to strengthen the protection of traditional knowl - Costa Rica : The Law of Biodiversity edge , innovations , and practices of indigenous , black , and The Law of Biodiversity established that the State will local communities that could take the form of a community use patents , trademarks , plant breeders â?? rights , copyrights , intellectual right system ( A ï쳌® ï쳌¤ ï쳌¥ ï쳌¡ ï쳌® C ï쳌¯ ï쳌­ ï쳌­ ï쳌µ ï쳌® ï쳌© ï쳌´ ï쳌¹ ï?? ï?? ï?? ï?? ) . So and sui generis systems to protect individual or collective far , no regional initiatives to protect traditional knowledge traditional knowledge , innovations , practices , and inven - have been proposed . In contrast , the ï?? ï?? ï?? ï?? Peruvian Law tions . This protection is extended to genetically modified No . ï?? ï?? ï?? ï?? ï?? provides a sui generis system for the protec - microorganisms , but excludes biological processes for tion of indigenous peoples â?? collective knowledge about the production of plants and animals , plants , animals , properties , uses , and characteristics of biological diversity sequences of genes , and any other organism as it exists and it has the following objectives : a ) promotion , respect , in nature ( this protection , however , was derogated by the protection , preservation , and development of collective Patents , Industrial Designs , and Utility Models Law as knowledge of indigenous peoples ; b ) promotion of the just amended by Law No . ï?? ï?? ï?? ï?? of ï?? ï?? January ï?? ï?? ï?? ï?? ) . Protection and equitable distribution of benefits derived from the use is also excluded for any inventions derived from tradi - of collective knowledge ; c ) promotion of the use of collec - tional knowledge or biological practices that are part of tive knowledge for the benefit of indigenous peoples and the public domain . The Law of Biodiversity also includes humanity ; d ) assurance that collective knowledge is used a compulsory licensing system that allows the State to with the prior informed consent of indigenous peoples ; use any invention derived from biological resources in a e ) development of capacities of indigenous peoples and situation of national emergency . mechanisms traditionally used by them to share and Intellectual property right authorities must consult the distribute benefits derived and shared collectively ; and ï쳌´ ï쳌¯ before granting protection of intellectual or industrial f ) prevention of the patenting of inventions derived from property related innovations that involve biodiversity ele - the collective knowledge of indigenous peoples without ments . The submission of the certificate of origin and prior taking into account the novelty and inventive level of such informed consent will be required . The Law of Biodiversity knowledge . The law creates three registers for the protec - also establishes that under sui generis community intel - tion of collective knowledge as follows : a ) national register lectual rights , the State protects traditional knowledge , for collective knowledge that is in the public domain ; b ) practices , and innovations of indigenous communities . A national register for confidential collective knowledge ; and participatory process mandated in the Law of Biodiversity c ) local registers for either kind of collective knowledge . is working on the sui generis community intellectual rights . ï쳌© ï쳌® ï쳌¤ ï쳌¥ ï쳌£ ï쳌¯ ï쳌° ï쳌© will be in charge of the first two registers and Consultations with indigenous and peasant communities will provide support for local registers if requested by are expected to be completed in ï?? ï?? ï?? ï?? . local communities . This organization will also submit to The Law of Biodiversity also focuses on the protec - patent offices worldwide the public information registered tion of knowledge by means of a register . During the by indigenous communities in order to block unauthorized consultation process with local communities ( and later ) , patent applications of products and processes that may have been developed with such knowledge ( P ï쳌¥ ï쳌² ï쳌µ ï쳌¶ ï쳌© ï쳌¡ ï쳌® they may register their knowledge , traditional practices , or ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : D ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¯ ï쳌¦ P ï쳌¯ ï쳌¬ ï쳌© ï쳌£ ï쳌© ï쳌¥ ï쳌³ ï쳌© ï쳌® P ï쳌¬ ï쳌¡ ï쳌£ ï쳌¥ ï쳌¡ ï쳌® ï쳌¤ ï쳌© ï쳌® P ï쳌² ï쳌¯ ï쳌§ ï쳌² ï쳌¥ ï쳌³ ï쳌³ innovations . The service is voluntary and free of charge . ( ï쳌³ ï쳌¥ ï쳌­ ï쳌¡ ï쳌² ï쳌® ï쳌¡ ï쳌´ ï?? ï?? ï?? ï?? ) . This register will allow the ï쳌´ ï쳌¯ to reject any claim of in - The ï?? ï?? ï?? ï?? Industrial Property Act protects inventions tellectual property derived from knowledge protected by derived from genetic resources , but there is no protection this system . for traditional knowledge . Furthermore , the act does not Costa Rica has comprehensive legislation related to include requirements for disclosing the origin of samples ï쳌© ï쳌° ï쳌² s that include : a ) the Patent , Drawings and Utility or knowledge used for the invention of products or pro - Models Law No . ï?? ï?? ï?? ï?? , emended by Law No . ï?? ï?? ï?? ï?? of cesses that are to be patented . Under the act patents must ï?? ï?? January ï?? ï?? ï?? ï?? to make it compatible with ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ and b ) comply with the requirements of novelty , inventive step , Plant Breeders â?? Rights draft published in The Gazette on and industrial application , and there is an exception to ï?? ï?? August ï?? ï?? ï?? ï?? and yet to be approved . This draft was patenting biological and genetic material . However , the developed in accordance with the model law of ï쳌µ ï쳌° ï쳌¯ ï쳌¶ and Mexican patent office considers that once biological or its ï?? ï?? ï?? ï?? Act ( see Chapter ï?? ) . genetic materials have been isolated and characterized , it is no longer â?? as it is found in nature â?쳌 . Therefore , sequences Malaysia : of genes can be patented under Mexican law . Mexicoâ??s Draft federal bill on access to genetic resources ï쳌° ï쳌¶ ï쳌° ï쳌¡ also gives property rights to plant breeders for plant The draft does not recognize protection for : a ) plants , ani - varieties ( see Chapter ï?? ) . mals , and naturally occurring microorganisms , including Under Article ï?? ï?? ï?? of ï쳌² ï쳌³ ï쳌¤ ï쳌¡ , the inter - secretarial com - parts thereof and b ) biological and naturally occurring mission together with the Mexican council must develop microbiological processes . Approval of the competent measures to defend ï쳌© ï쳌° ï쳌² s of peasant and indigenous com - authority is required in order to obtain a patent that in - munities . However , no such measures have been adopted volves the use of biological resources . The draft has to so far by the Mexican government . Mexicoâ??s current be consistent with the provisions of the Malaysian Patent legislation does not provide a comprehensive protection Act of ï?? ï?? ï?? ï?? . It is not clear , however , whether genes are to traditional knowledge . The draft ï쳌¬ ï쳌¡ ï쳌µ ï쳌¢ ï쳌§ ï쳌² , however , patentable under the Act . It is necessary to harmonize includes a provision that promotes the evaluation of the the provisions of this Act with Malaysiaâ??s international proportion of â?? relevant knowledge â?쳌 given by each party in obligations under ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ . To satisfy the requirements of order to distribute the resulting ï쳌© ï쳌° ï쳌² s . There are no details ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ , Malaysia developed the draft Protection of New about how to implement this measure . The draft law also Plant Varieties bill . This is essentially a sui generis system proposes a register system to protect traditional knowledge for the protection of plant genetic resources . Congress has ( G ï쳌¡ ï쳌£ ï쳌¥ ï쳌´ ï쳌¡ P ï쳌¡ ï쳌² ï쳌¬ ï쳌¡ ï쳌­ ï쳌¥ ï쳌® ï쳌´ ï쳌¡ ï쳌² ï쳌© ï쳌¡ ï?? ï?? ï?? ï?? ) . not passed the bill yet . Moreover , there is no specific provision in the act to Nicaragua : Draft Law of Biodiversity protect indigenous knowledge related to genetic resources . The draft law states that access contracts must refer to the Malaysia has been discussing a proposal for a sui generis type of ï쳌© ï쳌° ï쳌² protection that will be sought for inventions system of community intellectual rights . The systemâ??s derived under the agreement . This draft also proposes sui objectives are to : a ) recognize the ownership rights of generis community intellectual rights to protect the knowl - communities over their knowledge , innovations , and prac - edge , practices , and innovations of local communities . In tices ; b ) protect communities â?? knowledge , innovations , and addition , the draft promotes the development of a regis - practices ; and c ) ensure the equitable sharing of benefits ter to protect the knowledge of these communities . This derived from their genetic resources and knowledge . The register will be voluntary and confidential . The draft law proposal , however , was very controversial and it was not also requires ï쳌© ï쳌° ï쳌² authorities to ask for access authorization included in the draft Access to Genetic Resources bill ( see ( including proof that ï쳌° ï쳌© ï쳌£ was sought ) before ï쳌© ï쳌° ï쳌² protection Chapter ï?? ï?? ) . is granted on inventions derived from biodiversity or indig - enous knowledge . In late ï?? ï?? ï?? ï?? , the government developed Mexico : EEEPGA , WGA , SFDGA , and draft LAUBGR a proposal for sui generis community intellectual rights Neither ï쳌¥ ï쳌¥ ï쳌¥ ï쳌° ï쳌§ ï쳌¡ nor ï쳌· ï쳌§ ï쳌¡ includes provisions that pro - to protect the knowledge , practices , and innovations of tect intellectual property derived from genetic resources local communities or traditional knowledge . However , ï쳌³ ï쳌¦ ï쳌¤ ï쳌§ ï쳌¡ protects the Nicaraguaâ??s ï쳌© ï쳌° ï쳌² laws include the Patent Law ï?? ï?? ï?? and knowledge of traditional communities about local forest plant breeders â?? rights to protect new plant varieties . Plants , biological resources found in their land . Article ï?? ï?? ï?? states animals , and biological processes to produce any organ - that collectors of forest biological resources for commer - ism are excluded from patent protection . But protection cial and noncommercial purposes must acknowledge the is given to sequences of genes that have been isolated rights of indigenous communities over the knowledge , and characterized and it can be extended to any product ownership , and use of local varieties . Furthermore , any that includes such a sequence ( J . Hernández , pers . comm . patenting of forest genetic resources and by - products November ï?? ï?? ï?? ï?? ) . will be legally void unless the collector acknowledges the aforementioned rights of indigenous communities . Philippines : EO 247 and Wildlife Act However , some exceptions may apply in the context ï쳌¥ ï쳌¯ ï?? ï?? ï?? recognizes the rights of indigenous communities of agreed relevant international agreements or treaties to their knowledge and practices when this information is ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ used for commercial purposes . The Philippines , however , production of plants and animals . Applications for gene has yet to pass a sui generis ï쳌© ï쳌° ï쳌² system that will cover tra - sequences are accepted by the patent office , but there are ditional knowledge associated with biological and genetic still problems with interpretation of the law and they may resources of local and indigenous communities . The ï?? ï?? ï?? ï?? be denied . Thailandâ??s ï쳌° ï쳌¶ ï쳌° ï쳌¡ also protects new plant vari - Traditional Alternative Medicine Act protects knowledge eties , traditional varieties , community varieties , and wild of traditional medicine in a very limited way . The law varieties ( J . Donavanik , pers . comm . January ï?? ï?? ï?? ï?? ) . Under provides for a policy for indigenous groups seeking to ï쳌² ï쳌¦ ï쳌³ ï쳌² ï쳌£ ï쳌¦ ï쳌¡ bioprospectors must obtain the approval of ï쳌² ï쳌¦ ï쳌¤ protect their knowledge . This policy , however , is still under before they apply for intellectual property right protec - development ( P . Benavidez , pers . comm . July ï?? ï?? ï?? ï?? ) . tion ( i.e . , copyright , patent , trademark , etc . ) . Depending Both the ï?? ï?? ï?? ï?? Intellectual Property Code and the ï?? ï?? ï?? ï?? on particulars of the situation ï쳌² ï쳌¦ ï쳌¤ may ask bioprospectors Plant Variety Protection Law comply with ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ . The to share ownership of intellectual property protection ( C . code excludes plant varieties , animal breeds , or essen - Hutacharern , pers . comm . June ï?? ï?? ï?? ï?? ) . tially biological processes for the production of plants or The ï쳌¡ ï쳌° ï쳌° ï쳌´ ï쳌­ ï쳌© provides a sui generis system to protect animals from patent protection . However , microorganisms traditional knowledge associated with formulae of medi - and nonbiological and microbiological processes can be cines derived from plants , animals , bacteria , and minerals . protected by patents . The Plant Variety Protection Law al - According to the act , such protection takes effect when lows compulsory licensing at any time after two years from such knowledge ( oral or written ) about formulae of the granting of the protection . This situation may occur if medicines is registered at the National Institute of Thai the variety is required for the production of any medicine Traditional Medicine . The act creates the following three or food preparation , among other reasons ( see Chapter categories of sui generis â?? medicinal intellectual property ï?? ) . Protection under the Law is patterned after the ï쳌µ ï쳌° ï쳌¯ ï쳌¶ rights â?쳌 : plant breeders â?? rights . ï쳌¥ ï쳌¯ ï?? ï?? ï?? also includes a compulsory â?¢ The national formula of traditional Thai drugs or licensing provision that applies to products or technologies the national text on traditional Thai medicine ; developed from the use of endemic species . In this case â?¢ general formula of traditional Thai drugs or gen - the invention must be available for use in the Philippines eral traditional Thai medicine document ; and without paying royalty to the inventor . â?¢ personal formula of traditional Thai drugs or The Indigenous Peoples â?? Rights Act of ï?? ï?? ï?? ï?? empha - personal text on traditional Thai medicine ( ï쳌® ï쳌© ï쳌´ ï쳌´ ï쳌­ sizes that indigenous communities â?? are entitled to the ï?? ï?? ï?? ï?? ) . recognition of the full ownership and control and protec - tion of their cultural and intellectual rights â?쳌 ( B ï쳌¡ ï쳌² ï쳌¢ ï쳌¥ ï쳌² et National formula is defined as the one that has a special al . ï?? ï?? ï?? ï?? ) . Under the act , bioprospectors have to obtain the medical or public health value ; general formula is the one ï쳌° ï쳌© ï쳌£ from indigenous communities . Unfortunately , there that has been widely used , and personal formula is the is no provision in the intellectual property code of the one that is not national or general and has been developed country that denies intellectual property right protection by a person or group of persons . The inventor , improver , to bioprospectors who fail to present the ï쳌° ï쳌© ï쳌£ of the local or inheritor of the personal formula may register such community that provided the genetic resource or knowl - knowledge . The act protects registered knowledge for the edge ( P . Benavidez , pers . comm . March ï?? ï?? ï?? ï?? ) . lifetime of the bearer and ï?? ï?? additional years from the time the owner or last owner ( in case of joint ownership ) of the Samoa : CABSSBR registration has passed away ( ï쳌® ï쳌© ï쳌´ ï쳌´ ï쳌­ ï?? ï?? ï?? ï?? ) . The conditions provide that traditional knowledge has to be acknowledged in any benefit - sharing agreement ( ï쳌¤ ï쳌¬ ï쳌³ ï쳌¥ USA : NPS research specimen collection permit ï?? ï?? ï?? ï?? ) . This includes the negotiation of access to ï쳌© ï쳌° ï쳌² s or The PatentAct of ï?? ï?? ï?? ï?? defined patentable statutory subject traditional knowledge owned by or vested in any indi - matter as â?? any new and useful art , machine , manufacture , vidual , group of individuals , or representatives thereof , or composition of matter , or any new or useful improve - and the payment of fees , royalties , or license payments ment [ thereof ] â?쳌 . The Plant Patent Act of ï?? ï?? ï?? ï?? gave pro - for such rights or access . The ï?? ï?? ï?? ï?? Intellectual Property tection to clonally propagated varieties of plants such as Rights Law and the ï?? ï?? ï?? ï?? Village Fono Act also provide fruit trees and tubers . In ï?? ï?? ï?? ï?? , the ï쳌° ï쳌¶ ï쳌° ï쳌¡ granted protection a general framework for the recognition of ownership of to new , uniform , and distinct plant varieties . In ï?? ï?? ï?? ï?? , the traditional knowledge . These regulations , however , are ï쳌µ ï쳌³ ï쳌¡ Supreme Court opened the door for patents to be ap - likely to be strengthened with future legislation ( D ï쳌© ï쳌¶ ï쳌© ï쳌³ ï쳌© ï쳌¯ ï쳌® plied to plants , animals , microorganisms , genes , and ï쳌¤ ï쳌® ï쳌¡ ï쳌¯ ï쳌¦ E ï쳌® ï쳌¶ ï쳌© ï쳌² ï쳌¯ ï쳌® ï쳌­ ï쳌¥ ï쳌® ï쳌´ ï쳌¡ ï쳌® ï쳌¤ C ï쳌¯ ï쳌® ï쳌³ ï쳌¥ ï쳌² ï쳌¶ ï쳌¡ ï쳌´ ï쳌© ï쳌¯ ï쳌® ï?? ï?? ï?? ï?? ) . sequences . In late ï?? ï?? ï?? ï?? , the Supreme Court confirmed that plant varieties are eligible for protection by utility Thailand : PVPA , RFSRCFA , and APPTMI patents , as well as under the Plant Patent Act of ï?? ï?? ï?? ï?? and Existing ï쳌© ï쳌° ï쳌² laws have been revised to be in line with the ï쳌° ï쳌¶ ï쳌° ï쳌¡ of ï?? ï?? ï?? ï?? . The distinction between what the law the requirements of the ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ Agreement . Thailandâ??s rewards ( new , useful , and nonobvious discoveries based ï?? ï?? ï?? ï?? Patent Act ( amended in ï?? ï?? ï?? ï?? and ï?? ï?? ï?? ï?? ) protects on research results ) and what the law protects ( naturally inventions derived from biological resources except for plants , animals , or essentially biological processes for the occurring life forms that remain free for all to use ) is at ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : D ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¯ ï쳌¦ P ï쳌¯ ï쳌¬ ï쳌© ï쳌£ ï쳌© ï쳌¥ ï쳌³ ï쳌© ï쳌® P ï쳌¬ ï쳌¡ ï쳌£ ï쳌¥ ï쳌¡ ï쳌® ï쳌¤ ï쳌© ï쳌® P ï쳌² ï쳌¯ ï쳌§ ï쳌² ï쳌¥ ï쳌³ ï쳌³ the core of the biodiversity prospecting access and benefit - ( ï쳌· ï쳌© ï쳌° ï쳌¯ ) which is examining proposals to protect traditional knowledge . Specifically , the Global Intellectual Property sharing issues first pioneered in the ï쳌µ ï쳌³ ï쳌¡ at Yellowstone Division and the Intergovernmental Committee on Genetic ( see Chapter ï?? ) . Resources , Traditional Knowledge and Folklore of ï쳌· ï쳌© ï쳌° ï쳌¯ Analysis : have been looking at the ï쳌© ï쳌° ï쳌² needs of holders of traditional IPRs and the Protection of Traditional Knowledge knowledge and the feasibility of establishing databases or Traditional and sui generis ï쳌© ï쳌° ï쳌² systems , registers , ï쳌° ï쳌© ï쳌£ registers to protect traditional or indigenous knowledge , requirements , certificates of origin , and benefit - sharing among other issues . agreements are the main instruments used by most coun - ï쳌· ï쳌© ï쳌° ï쳌¯ can provide a space for the discussion of these tries to protect scientific and the traditional knowledge at issues but it does not have the power to oblige countries different levels.All of the countries reviewed above , except to develop legislation that protects traditional knowledge . for Samoa and Malaysia , have ï쳌© ï쳌° ï쳌² legislation that complies ï쳌· ï쳌´ ï쳌¯ can utilize economic sanctions to advance these is - fully with ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ . They provide intellectual protection to sues worldwide . However , there is still great disagreement inventions derived from biological resources that exclude among countries about fundamental issues such as the plants , animals , and biological processes to develop these patenting of life and whether the ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ agreement should organisms . These countries , except for Costa Rica , also be amended in order to make it consistent with ï쳌£ ï쳌¢ ï쳌¤ ob - have legislation to protect new plant varieties and Thailand ligations such as the protection of traditional knowledge extends this protection to wild plant varieties . However , ï쳌© ï쳌° ï쳌² and ï쳌¡ ï쳌¢ ï쳌³ requirements . For example , in early June ï?? ï?? ï?? ï?? , at protection depends on the application of the patentability a meeting of the ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ council , the Africa Group empha - test . In other words , inventions have to be novel , useful , sized that ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ should include some sort of international and nonobvious . Unlike Australia , Costa Rica , Mexico , mechanism to ensure the effective protection of traditional Nicaragua , and the ï쳌µ ï쳌³ ï쳌¡ , the Andean Community does not knowledge . In contrast , the ï쳌µ ï쳌³ ï쳌¡ called for traditional protect gene sequences that have been isolated and charac - knowledge to be removed from the agenda of the ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ terized . According to these countries , genes exist in nature Council . Furthermore , the Africa Group called for a ban and their mere isolation does not comply with the novelty on the patenting of life , a request that was opposed by the and inventive steps of the patentability test . Thailand ac - ï쳌µ ï쳌³ ï쳌¡ and the European Union . On the other hand , the Indian cepts applications for the protection of gene sequences , Group proposed that ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ should be amended in order to but patent clerks still have trouble interpreting the norm ( J . require patent applicants to disclose the source of origin of Donavanik , pers . comm . February ï?? ï?? ï?? ï?? ) . Bioprospectors the biological resource and traditional knowledge and to may also object to the fact that the Andean Community provide evidence of ï쳌° ï쳌© ï쳌£ and benefit sharing . This issue was ( Decision ï?? ï?? ï?? ) and Costa Rica ( Law of Biodiversity ) in - supported by the European Union , but it was not clarified clude a compulsory licensing provision that allows these whether it should be addressed by ï쳌· ï쳌© ï쳌° ï쳌¯ or ï쳌· ï쳌´ ï쳌¯ . Japan , nations to use any invention without having to pay royalties Canada , and the ï쳌µ ï쳌³ ï쳌¡ argued that ï쳌· ï쳌© ï쳌° ï쳌¯ was already working in case of national emergency or security . on these issues and proposed to wait for the results before Can traditional ï쳌© ï쳌° ï쳌² systems be applied to protect in - further action was taken ( A ï쳌® ï쳌¯ ï쳌® ï쳌¹ ï쳌­ ï쳌¯ ï쳌µ ï쳌³ ï?? ï?? ï?? ï?? ) . ventions derived from the use of traditional knowledge ? More than ï?? ï?? % of the countries examined in this re - Patents , for example , protect only those inventions that port are already addressing these issues in their national can only be attributed to individuals or small groups policies . These countries have either included in their ï쳌¡ ï쳌¢ ï쳌³ of people . Some argue that in traditional societies the policies provisions that call for a sui generis community sources of knowledge can be traced to individuals , kin - rights system to protect indigenous knowledge , or are ex - ship , or gender - based groups . On the other hand , most amining options for the development of a similar system . traditional knowledge is in the public domain and cannot Furthermore , these countries are already taking additional be attributable to a single community or geographical loca - measures to protect traditional knowledge and to ensure tion making it ineligible for patent protection . In addition , that bioprospectors comply with ï쳌¡ ï쳌¢ ï쳌³ regulations . These many communities resent the fact that their traditional include requirements for national ï쳌© ï쳌° ï쳌² authorities to ask knowledge has been stolen to patent plants or inventions for access contracts , ï쳌° ï쳌© ï쳌£ evidence , or some certificate of derived from plants . Examples include the ayahuasca origin when they receive applications for ï쳌© ï쳌° ï쳌² protection ( ï쳌£ ï쳌¯ ï쳌© ï쳌£ ï쳌¡ ï?? ï?? ï?? ï?? ) , the neem tree ( D ï쳌µ ï쳌´ ï쳌¦ ï쳌© ï쳌¥ ï쳌¬ ï쳌¤ ï?? ï?? ï?? ï?? ) , and the of products and processes that have been derived from enola bean ( see Box ï?? of Chapter ï?? ) . Others have ethical local biological resources or traditional knowledge . The concerns about the idea of monopolizing and commercial - Andean Community and Costa Rica already have this izing their knowledge . These concerns and issues have kind of provision in their ï쳌¡ ï쳌¢ ï쳌³ laws and Australia and discouraged most traditional communities from facilitating Nicaragua are proposing similar measures in their draft the use of knowledge for patenting purposes . regulations . Mexicoâ??s General Law of Sustainable Forestry In the last few years there has been intensive debate at a Development also requires bioprospectors to provide ï쳌° ï쳌© ï쳌£ national and international level to protect indigenous or tra - evidence when inventions derived from forest biological ditional knowledge . This debate has reached international resources are patented . However , this requirement applies bodies like the World Intellectual Property Organization only to local varieties found in forests owned by indigenous ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ communities . Requirements for registers of traditional model benefit - sharing agreement will include a require - ment that at least some of the benefits under the contract knowledge have been included in the ï쳌¡ ï쳌¢ ï쳌³ law of Costa should promote biodiversity conservation in the area where Rica and proposed by the draft ï쳌¡ ï쳌¢ ï쳌³ law of Nicaragua . samples are collected . According to D ï쳌µ ï쳌´ ï쳌¦ ï쳌© ï쳌¥ ï쳌¬ ï쳌¤ ( ï?? ï?? ï?? ï?? ) , â?? failure to register does The regulations will also require an ï쳌¥ ï쳌© ï쳌¡ when bio - not surrender the innovation rights , but doing so may prospecting activities are likely to have a significant im - block a patent application â?쳌 . Blocking potential patent pact on the environment . If this is the case , within ï?? ï?? days applications by advertising prior art is precisely the main after receiving the access application the applicant must objective of the register of the American Association for provide the Minister of the Environment and Heritage with the Advancement of Science ( Science and Human Rights information about the potential environmental impacts of Program ) known as Traditional Ecological Knowledge - 32 the proposed access . Within ï?? ï?? days of receiving such Prior Art Data Base . The register has over ï?? ï?? , ï?? ï?? ï?? entries information , the Minister must publish a notice inviting that include traditional knowledge about medicinal plants anyone to comment on the likely impacts , and within five that has been collected mainly online from other websites . days after the end of the period given in the invitation for The system also gives the option to holders of traditional comments , the Minister must give the applicant a copy of knowledge to submit information to the register . However , the comments received . Finally , the applicant must give traditional knowledge under this register is available and the Minister a response to these comments . There is no of easy access to anyone , not only to patent examiners , timeframe for such a response , but presumably , it is in and traditional communities may not want to share their the applicantâ??s interests to respond expeditiously . Then , at knowledge with pharmaceutical companies and other us - intervals of less than ï?? ï?? months , the Minister must invite ers . Holders of traditional knowledge may want to maintain applications from anyone who wants to be informed of control over their knowledge and keep their options open applications for access permits where an ï쳌¥ ï쳌© ï쳌¡ by public for negotiation with potential bioprospectors . To this pur - notice is required . The Minister is also required to keep a pose Nicaragua proposes a confidential register and Peru , register of information about permits . The register must be under Peruvian Law No . ï?? ï?? ï?? ï?? ï?? , protects access to collec - available for public scrutiny . However , information is not tive knowledge by a confidential register ( one of the three be included in it if the Minister believes the information is registers provided by the law ) requiring written consent of confidential or culturally sensitive ( see Chapter ï?? ) . the holders of such knowledge . Under Thailandâ??s ï쳌¡ ï쳌° ï쳌° ï쳌´ ï쳌­ ï쳌© , a register protects traditional knowledge about medicinal Colombia , Ecuador , and Peru : Decision 391 formulae that are in the public domain and that is regis - Decision ï?? ï?? ï?? regulates access to the regionâ??s genetic re - tered by individual or collective owners . However , the act sources in order to promote the conservation and sustain - is not clear about whether the register protects sensitive able use of biodiversity , among other reasons . This law information in a confidential manner . The Philippineâ??s also encourages the development of projects and technolo - ï?? ï?? ï?? ï?? Traditional Alternative Medicine Act that protects gies that promote the conservation and sustainable use of knowledge of traditional medicine is not operational yet , biodiversity and its derivative products that contribute to and it is uncertain whether it will use the register system to the well being of local communities . Therefore , access protect traditional knowledge ( P . Benavidez , pers . comm . applications , access contract , and accessory contracts July ï?? ï?? ï?? ï?? ) . must include conditions that support research activities that promote the conservation and sustainable use of In situ Biodiversity biodiversity . Bioprospectors should be guided by the Conservation and Sustainable Use precautionary principle . Under Decision ï?? ï?? ï?? , the Andean committee on ge - Some of the in situ biodiversity conservation and sustain - netic resources will also design and implement programs able use activities listed by Article ï?? of the ï쳌£ ï쳌¢ ï쳌¤ include : a ) to ensure the conservation of genetic resources and will establishing a system of protected areas ; b ) promoting the analyze the viability and convenience of an Andean fund protection of ecosystems , habitats , and populations ; and for the conservation of these resources . This approach is c ) adopting measures to avoid or minimize impacts on the already being followed at a national level . The Peruvian use of biological diversity . Even before the ï쳌£ ï쳌¢ ï쳌¤ came into draft regulation on access to genetic resources proposes force , bioprospecting was identified as a potential source of the creation of a national trust fund for the conservation , funding and technical expertise to promote the conserva - research and development of genetic resources . tion of biodiversity and its sustainable use ( S ï쳌£ ï쳌¨ ï쳌· ï쳌¥ ï쳌© ï쳌´ ï쳌º ï쳌¥ ï쳌² Each country may also require an ï쳌¥ ï쳌© ï쳌¡ from access et al . ï?? ï?? ï?? ï?? ) . applicants and this information will be included in a Australia : Draft EPBCAR file that will be available for public scrutiny . In addition , The purpose of the regulations is to provide for the control member countries may also impose partial or full access of access to biological resources in Commonwealth areas restrictions if they identify that access activities may : a ) while promoting the conservation and sustainable use endanger or threaten rare , endemic , or any other species , of biological diversity . Therefore , the regulations and a subspecies , variety , or race ; b ) endanger the structure or ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : D ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¯ ï쳌¦ P ï쳌¯ ï쳌¬ ï쳌© ï쳌£ ï쳌© ï쳌¥ ï쳌³ ï쳌© ï쳌® P ï쳌¬ ï쳌¡ ï쳌£ ï쳌¥ ï쳌¡ ï쳌® ï쳌¤ ï쳌© ï쳌® P ï쳌² ï쳌¯ ï쳌§ ï쳌² ï쳌¥ ï쳌³ ï쳌³ function of ecosystems ; c ) cause undesirable or uncon - if bioprospecting activities are likely to compromise the viability of species , habitats , and ecosystems . Article ï?? ï?? trollable environmental and socioeconomic impacts ; d ) ï쳌¢ ï쳌© ï쳌³ states that any income received from permits , authoriza - cause biosafety impacts ; and e ) affect genetic resources or tions , and licenses ( derived from bioprospecting projects ) strategic regions . In Peru , under Law No . ï?? ï?? ï?? ï?? ï?? , ï쳌© ï쳌® ï쳌¤ ï쳌¥ ï쳌£ ï쳌¯ ï쳌° ï쳌© will be used to promote the conservation and restoration of may reject the registration of the license signed between biodiversity in the areas where specimens were collected . bioprospectors and representatives of indigenous com - Also , the ï쳌¥ ï쳌¥ ï쳌¥ ï쳌° ï쳌§ ï쳌¡ provides for the implementation of ï쳌¥ ï쳌© ï쳌¡ munities if national environment authorities prove that studies when any activity is likely to cause damage to lo - access activities will cause damage to the environment cal ecosystems or public health . Furthermore , Article ï?? ï?? ï?? and parties to the agreement refuse to mitigate such dam - of ï쳌³ ï쳌¦ ï쳌¤ ï쳌§ ï쳌¡ states that any utilization of forest resources , age ( P ï쳌¥ ï쳌² ï쳌µ ï쳌¶ ï쳌© ï쳌¡ ï쳌® C ï쳌¯ ï쳌® ï쳌§ ï쳌² ï쳌¥ ï쳌³ ï쳌³ ï?? ï?? ï?? ï?? ) . either for commercial or noncommercial purposes , in areas Costa Rica : The Law of Biodiversity which are habitats for endemic , threatened , or endangered The general goal of this law is to promote the conser - species of native flora and fauna , must be done without vation and sustainable use of biodiversity and to ensure altering the environmental conditions which allow their the fair and equitable sharing of benefits derived from subsistence , development and evolution ( ï쳌³ ï쳌¥ ï쳌­ ï쳌¡ ï쳌² ï쳌® ï쳌¡ ï쳌´ ï?? ï?? ï?? ï?? ) . it . Therefore , the law establishes that up to ï?? ï?? % of the Similarly , Article ï?? ï?? of ï쳌· ï쳌§ ï쳌¡ emphasizes that permits will research budget and ï?? ï?? % of royalties of access projects not be granted if collecting activities affect the viability of will go to the national system of conservation areas , the populations , species , habitats , and ecosystems ( ï쳌³ ï쳌¥ ï쳌­ ï쳌¡ ï쳌² ï쳌® ï쳌¡ ï쳌´ private owner , or indigenous community . Conservation of ï?? ï?? ï?? ï?? ) . ecosystems is also one of the criteria stated by the ï쳌§ ï쳌¡ ï쳌° for Two of the main objectives of the draft ï쳌¬ ï쳌¡ ï쳌µ ï쳌¢ ï쳌§ ï쳌² are the evaluation or approval of the access applications . to regulate the access to genetic resources and to ensure The ï쳌§ ï쳌¡ ï쳌° also allows the imposition of restrictions on the conservation of biological and genetic resources . The access to genetic resources to ensure their conservation and draft law also proposes the establishment of a trust fund sustainable use . â?? To establish complete or partial restric - for the conservation and use of genetic resources and re - tions some of the elements that will be considered are : a ) quires an ï쳌¥ ï쳌© ï쳌¡ of proposed activities including measures the danger of extinction of the species , subspecies , race , or that will be taken to mitigate negative impacts ( G ï쳌¡ ï쳌£ ï쳌¥ ï쳌´ ï쳌¡ variety ; b ) reasons of scarcity and endemic conditions ; c ) P ï쳌¡ ï쳌² ï쳌¬ ï쳌¡ ï쳌­ ï쳌¥ ï쳌® ï쳌´ ï쳌¡ ï쳌² ï쳌© ï쳌¡ ï?? ï?? ï?? ï?? ) . vulnerable or fragile conditions in the structure or function Nicaragua : Draft Law of Biodiversity of the ecosystems ; d ) adverse effects on human health , the The draft law regulates access to genetic resources while species , and the ecosystems or on essential elements of the conserving biological diversity.Access to genetic resources autonomy or cultural identity of peoples and communities ; will require an environmental permit that must be issued and e ) strategic genetic resources or geographical areas based on a previous analysis of environmental impacts and qualified as such . â?쳌 ( see Chapter ï?? ) . Access for military risks of access activities . The evaluation of access applica - purposes is to be prohibited in all cases . An ï쳌¥ ï쳌© ï쳌¡ can also tions will take into account whether proposed activities be requested by the ï쳌´ ï쳌¯ . contribute to : a ) the conservation and sustainable use of Malaysia : biological and genetic resources and b ) the preservation of Draft federal bill on access to genetic resources endemic , threatened , or endangered species . Access will Under this draft law , when an access application is made be denied when access activities : a ) endanger or threaten the official carrying out the evaluation of the application one or more species and b ) cause uncontrolled ecological , will take into consideration : a ) the conservation status of social , economic , and cultural environmental impacts . In the resource that will be collected or used ; b ) the contribu - any case , the National Biodiversity Institute will take into tion of the project to the conservation and sustainable use account the precautionary principle to ensure that access of the biological resources ; and c ) adverse impacts , risks , activities do not deplete biological diversity . and dangers of the project to any component of biologi - Philippines : EO 247 and Wildlife Act cal diversity and its sustainable use . Bioprospectors are Under ï쳌¥ ï쳌¯ ï?? ï?? ï?? , access applicants , the government , and local required to submit an environmental and socioeconomic communities may define actions to ensure conservation of impact assessment . biological diversity as part of benefit - sharing agreements . When traditional knowledge cannot be attributed to a However , this is up to the parties . There is no financing particular community another provision of the bill propos - mechanism or trust fund in place to support biodiversity es the establishment of a common trust fund . The purpose conservation objectives . The Wildlife Act provides such of the trust fund will be not only to promote the welfare of a mechanism . Under the act a wildlife management fund indigenous communities , but also for the conservation and is created to finance restoration of habitats affected by sustainable use of biodiversity ( see Chapter ï?? ï?? ) . activities committed in violation of the law . The fund also Mexico : EEEPGA , WGA , SFDGA , and draft LAUBGR supports scientific research , enforcement and monitoring , One of the goals of the ï쳌¥ ï쳌¥ ï쳌¥ ï쳌° ï쳌§ ï쳌¡ is to promote the conser - and local capacity - building activities . vation of biological diversity . Access will not be granted The actâ??s objectives include : a ) conserve and protect ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ wildlife species and their habitats to promote ecological determine the environmental impact of proposed activities ( see Chapter ï?? ) . balance and enhance biological diversity ; b ) regulate the collection and trade of wildlife ; and c ) initiate or support Analysis : scientific studies on the conservation of biological diver - In situ Biodiversity Conservation and Sustainable Use sity.Access applicants may be asked to prepare an ï쳌¥ ï쳌© ï쳌¡ . This All of the ï쳌¡ ï쳌¢ ï쳌³ laws and policies mentioned above , except is usually required for projects that will carry out activities for Samoaâ??s conditions , promote the conservation of in environmentally critical areas . However , no ï쳌¥ ï쳌© ï쳌¡ has ever biological diversity and trust funds are the main strategy been required from any applicant ( see Chapter ï?? ) . to collect and distribute monies for conservation and sus - The ï?? ï?? ï?? ï?? draft Guidelines for BioprospectingActivities tainable use goals . But , in most of these countries , these ( see endnote ï?? ï?? ) state that local communities shall ensure are stated as general goals , and it is up to government that the funds received are used solely for biodiversity authorities and access applicants to negotiate biodiversity conservation or environmental protection , including alter - conservation activities as part of benefit - sharing agree - native or supplemental livelihood opportunities for com - ments . Costa Ricaâ??s Law of Biodiversity is the only policy munity members . Furthermore , any bioprospecting activity that specifically states that bioprospectors must invest a involving species listed under ï쳌£ ï쳌© ï쳌´ ï쳌¥ ï쳌³ and the ï쳌© ï쳌µ ï쳌£ ï쳌® Red List percentage of the research budget and royalties in the areas shall be governed by these guidelines in addition to specific where genetic resources are collected . If the collection site regulations on the conservation of these species . is part of the national system of conservation areas , benefits are likely to go into conservation initiatives . However , if Samoa : CABSSBR collections take place in other public land , or in private or Samoaâ??s conditions make no reference to the use of indigenous land there is no guarantee that benefits will go benefits from bioprospecting for conservation purposes . into conservation activities ( see Chapter ï?? ) . However , once the access application has been submitted Article ï?? ï?? ( ï?? ) of the ï쳌£ ï쳌¢ ï쳌¤ states that Contracting Parties the Minister of Lands , Surveys , and Environment may must â?? create conditions to facilitate access to genetic re - require an ï쳌¥ ï쳌© ï쳌¡ to be conducted . 33 sources for environmentally sound uses â?쳌 . All of the countries examined above may require bioprospectors to Thailand : PVPA , RFSRCFA , and APPTMI present some sort of proof ( i.e . , ï쳌¥ ï쳌© ï쳌¡ ) that access activities ï쳌° ï쳌¶ ï쳌° ï쳌¡ and ï쳌¡ ï쳌° ï쳌° ï쳌´ ï쳌­ ï쳌© provide for the establishment of trust will not have a negative impact on biological diversity funds called the â?? Plant Varieties Protection Fund â?쳌 and and ecological processes . In some cases the scope of the the â?? Fund on Traditional Thai Medicine Intelligence â?쳌 ï쳌¥ ï쳌© ï쳌¡ is broadly defined to include social and economic respectively , to promote activities related to the conserva - impacts . This is a justifiable concern given available evi - tion , research , and development of plant varieties and the dence of negative impacts in the past . D ï쳌¡ ï쳌¶ ï쳌© ï쳌³ ( ï?? ï?? ï?? ï?? ) and conservation and promotion of intelligence on traditional P ï쳌© ï쳌® ï쳌¨ ï쳌¥ ï쳌© ï쳌² ï쳌¯ ( ï?? ï?? ï?? ï?? ) , for example , report that the collection Thai medicine , respectively . ï쳌° ï쳌¶ ï쳌° ï쳌¡ requires ï쳌¥ ï쳌© ï쳌¡ studies for of leaves from wild jaborandi ( Pilocarpus jaborandi ) by access activities likely to have a negative environmental an American - Brazilian bioprospecting project had a nega - impact and ï쳌¡ ï쳌° ï쳌° ï쳌´ ï쳌­ ï쳌© proposes the development of a â?? Plan tive effect on the shrub as well as on the local economy for the conservation of herbs â?쳌 to promote the conservation and community that had become totally dependent on of areas where animals , plants , bacteria , and minerals used the commercial exploitation of the species . Similarly , in for the development of medicines are found . Kenya the ï쳌µ ï쳌³ ï쳌¡ National Cancer Institute was responsible ï쳌² ï쳌¦ ï쳌³ ï쳌² ï쳌£ ï쳌¦ ï쳌¡ does not specifically promote the use of bio - for harvesting the whole adult population ( ï?? ï?? , ï?? ï?? ï?? kg ) of prospecting benefits for biodiversity conservation activi - the shrub Maytenus buchanii that is the source of the can - ties . However , conservation is one of the mandates of the cer compound maytansine ( O ï쳌¬ ï쳌¤ ï쳌¦ ï쳌© ï쳌¥ ï쳌¬ ï쳌¤ ï?? ï?? ï?? ï?? ) . Furthermore , Royal Forest Department and it is safe to assume that a species such as Trilepidea adamsii , an endemic mistletoe of share of potential profits will go to this purpose . ï쳌² ï쳌¦ ï쳌³ ï쳌² ï쳌£ ï쳌¦ ï쳌¡ New Zealand , and Tecophilaea cyanocrocus , an endemic lily states that access permits may be cancelled if bioprospect - of central Chile , are extinct because they were overcollected ing activities cause negative impacts to the environment ( ï쳌¤ ï쳌¥ K ï쳌¬ ï쳌¥ ï쳌­ ï쳌­ ï?? ï?? ï?? ï?? ) . It is uncertain whether these species were and to natural , biological , and genetic resources . If samples critical to the survival of other species and to the structure are collected , one duplicate must remain in the facilities or function of the local ecosystem . But if this were the case , indicated by ï쳌² ï쳌¦ ï쳌¤ . If there is only one specimen available , both the ecosystem and the species dependent on the target it must remain in Thailand ( C . Hutacharern , pers . comm . species may have been affected by these bioprospecting June ï?? ï?? ï?? ï?? ) . activities . USA : NPS research specimen collection permit Enforcement and Monitoring The ï쳌® ï쳌° ï쳌³ operates consistently with the main conservation principles provided in the ï쳌£ ï쳌¢ ï쳌¤ . Bioprospectors that profit Enforcement and monitoring requirements are essential from research involving national park resources are ex - components of meaningful ï쳌¡ ï쳌¢ ï쳌³ laws and policies . The pected to invest the benefits resulting from their research motivation for these requirements is important not only in the conservation of the parkâ??s biological diversity . Under to ensure that benefits are distributed in a timely manner ï쳌® ï쳌¥ ï쳌° ï쳌¡ , ï쳌® ï쳌° ï쳌³ authorities may also require bioprospectors to but also to monitor the ability of species and ecosystems ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : D ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¯ ï쳌¦ P ï쳌¯ ï쳌¬ ï쳌© ï쳌£ ï쳌© ï쳌¥ ï쳌³ ï쳌© ï쳌® P ï쳌¬ ï쳌¡ ï쳌£ ï쳌¥ ï쳌¡ ï쳌® ï쳌¤ ï쳌© ï쳌® P ï쳌² ï쳌¯ ï쳌§ ï쳌² ï쳌¥ ï쳌³ ï쳌³ to recover from negative impacts and their capacity to Malaysia : continue delivering ecological services to society . Draft federal bill on access to genetic resources Existing monitoring and enforcement authorities would be Australia : Draft EPBCAR responsible for monitoring and enforcement of the provi - Enforcement of access regulations is likely to be carried sions of this draft bill , within their respective sectors or out by Environment Australia which manages compliance jurisdictions . These authorities will also have â?? powers of 34 with the ï쳌¥ ï쳌° ï쳌¢ ï쳌£ ï쳌¡ ï쳌² . Fifty penalty units are set for contra - arrests , entry , search , and seizure with respect to offenses vening the regulation which requires a permit for access under the law â?쳌 . Under this draft bill , when an access ap - to biological resources . The draft does not include any plication is made the applicant is required to submit an monitoring activities but the outline of the model contract ï쳌¥ ï쳌© ï쳌¡ ( see Chapter ï?? ï?? ) . proposes a section titled â?? Monitoring and review of the contract â?쳌 ( V ï쳌¯ ï쳌µ ï쳌­ ï쳌¡ ï쳌² ï쳌¤ ï?? ï?? ï?? ï?? ) . The regulations also require Mexico : EEEPGA , WGA , SFDGA , and draft LAUBGR an ï쳌¥ ï쳌© ï쳌¡ when collections are likely to harm the environment ï쳌³ ï쳌¥ ï쳌­ ï쳌¡ ï쳌² ï쳌® ï쳌¡ ï쳌´ enforces ï쳌¥ ï쳌¥ ï쳌¥ ï쳌° ï쳌§ ï쳌¡ , ï쳌· ï쳌§ ï쳌¡ , and ï쳌³ ï쳌¦ ï쳌¤ ï쳌§ ï쳌¡ and would and this may contribute to the development of baseline enforce the draft ï쳌¬ ï쳌¡ ï쳌µ ï쳌¢ ï쳌§ ï쳌² as well . The recently amended information about the status of biodiversity . But no de - Criminal Code regulates infringements to ï쳌¥ ï쳌¥ ï쳌¥ ï쳌° ï쳌§ ï쳌¡ , ï쳌· ï쳌§ ï쳌¡ , tails are provided about how to use this information in ï쳌³ ï쳌¦ ï쳌¤ ï쳌§ ï쳌¡ , and the draft ï쳌¬ ï쳌¡ ï쳌µ ï쳌¢ ï쳌§ ï쳌² ( if adopted ) . Article ï?? ï?? ï?? of the context of a monitoring program of impacts caused the code punishes with prison sentences of between one by collections over time . and ten years and fines of between ï?? ï?? ï?? and ï?? , ï?? ï?? ï?? minimum daily wages to those who â?? illegally execute any activity Colombia , Ecuador , and Peru : Decision 391 with traffic purposes , or capture , possess , transport , gather , Under Decision ï?? ï?? ï?? , the national authority in coordination introduce to the country , or extract from it , any specimen , with other organizations will set up appropriate monitor - its products , its subproducts , and other genetic resources , ing mechanisms to enforce contracts negotiated with of any wild flora and fauna species , terrestrial species , bioprospectors . The national support organization will or aquatic species on temporary prohibition , considered also be obliged to cooperate with the national authority endemic , threatened , endangered , subject to special pro - in monitoring and reporting about activities that involve tection , or regulated by any international treaty of which the use of genetic resources , derivative products , and Mexico has become a Party â?쳌 . Furthermore , â?? an additional traditional knowledge ( A ï쳌® ï쳌¤ ï쳌¥ ï쳌¡ ï쳌® C ï쳌¯ ï쳌­ ï쳌­ ï쳌µ ï쳌® ï쳌© ï쳌´ ï쳌¹ ï?? ï?? ï?? ï?? ) . The punishment will be applied when the described activities national authority is also authorized to enforce Decision are executed in or affect a natural protected area , or when ï?? ï?? ï?? according to national standards and mechanisms . For they are executed with a commercial purpose â?쳌 . This pun - example , if approved , the Peruvian draft regulation on ishment , for example , would include those using biological access to genetic resources would require bioprospectors material for biotechnological applications without proper to pay ï?? ï?? % of the total budget of the project as a bond permits issued under ï?? ï?? ï쳌¢ ï쳌© ï쳌³ . In addition to this , Article ï?? ï?? ï?? or guarantee that there will be total compliance with the of ï쳌· ï쳌§ ï쳌¡ punishes as an administrative infringement the provisions agreed on the contract ( M . Ruiz , pers . comm . use of biological material for biotechnological purposes January ï?? ï?? ï?? ï?? ) . Under Decision ï?? ï?? ï?? , the national author - without the acquisition of due permits . The ï쳌¥ ï쳌¥ ï쳌¥ ï쳌° ï쳌§ ï쳌¡ also ity of each country will also have to monitor the state of requires an ï쳌¥ ï쳌© ï쳌¡ when bioprospecting or any other activi - conservation of biological resources . However , explicit ties are likely to have a significant environmental impact provisions on monitoring biological and genetic resources ( see Chapter ï?? ) . for conservation purposes are not provided . Nicaragua : Draft Law of Biodiversity Costa Rica : The Law of Biodiversity Access contracts will include obligations for the establish - Once access is authorized , monitoring and control proce - ment of an evaluation and monitoring system that will dures begin at the expense of the ï쳌´ ï쳌¯ and in coordination be financed by the access applicant . These contracts will with the authorized representatives of the sites where also include penalties and sanctions for potential viola - access to the resources is taking place . The ï쳌´ ï쳌¯ has not tions . The law also includes penalties that range between been established due to lack of budget , personnel , con - ï?? ï?? , ï?? ï?? ï?? and ï?? ï?? ï?? , ï?? ï?? ï?? ï쳌µ ï쳌³ ï쳌¤ to be paid to the national envi - stitutional action , and political will , therefore monitoring ronmental trust fund . The draft law also requires and ï쳌¥ ï쳌© ï쳌¡ procedures have not been carried out . Infringements of the of the ecological , social , economic , and cultural impacts Law of Biodiversity will be penalized according to Costa ( ï쳌­ ï쳌¡ ï쳌² ï쳌¥ ï쳌® ï쳌¡ ï?? ï?? ï?? ï?? ) . Ricaâ??s Penal Code and pertinent national laws . Penalties for violations of access activities will be used to finance Philippines : EO 247 and Wildlife Act activities of ï쳌£ ï쳌¯ ï쳌® ï쳌¡ ï쳌§ ï쳌¥ ï쳌¢ ï쳌© ï쳌¯ and the ï쳌´ ï쳌¯ . An ï쳌¥ ï쳌© ï쳌¡ can also be Under ï쳌¥ ï쳌¯ ï?? ï?? ï?? the ï쳌© ï쳌¡ ï쳌£ ï쳌¢ ï쳌§ ï쳌² is set up to monitor and enforce requested by the ï쳌´ ï쳌¯ based on some general provisions of compliance with research agreements , as well as to coor - the LB related to ï쳌¥ ï쳌© ï쳌¡ . The evaluation is the responsibility dinate further institutional , policy , and technology devel - of the National Technical Secretariat . To date no ï쳌¥ ï쳌© ï쳌¡ has opment . The respective member agencies of the ï쳌© ï쳌¡ ï쳌£ ï쳌¢ ï쳌§ ï쳌² been requested of the National Biodiversity Institute or shall conduct monitoring of research agreements based on any other bioprospector ( see Chapter ï?? ) . a standard monitoring plan to be proposed by this commit - ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ tee . The plan will include a monitoring team responsible international and regional monitoring bodies . Collection , for establishing a mechanism to ensure the integration and hunting or possession of wildlife , their by - products and dissemination of the information generated from research , derivatives without the necessary permit is penalized collection , and utilization activities . The ï쳌° ï쳌¡ ï쳌· ï쳌¢ shall be with imprisonment of up to four years and a fine of up to the lead agency in monitoring the implementation of the ï?? ï?? ï?? ï?? , ï?? ï?? ï?? P ( see Chapter ï?? ) . research agreement . The ï쳌¤ ï쳌¥ ï쳌® ï쳌² regional offices shall also Samoa : CABSSBR participate in the monitoring . Bioprospectors have to submit a report on the status of the A second monitoring team headed by representatives analysis of samples every six months . However , the condi - of the Department of Science and Technology and the tions do not set up a monitoring structure or mechanism Department of Foreign Affairs monitors the progress of of proposed enforcement strategies , sanctions , or penal - the research , utilization , and commercialization outside ties ( ï쳌¤ ï쳌¬ ï쳌³ ï쳌¥ ï?? ï?? ï?? ï?? ) . The Minister of Lands , Surveys , and the country . The only commercial bioprospecting project Environment may ask bioprospectors to conduct an ï쳌¥ ï쳌© ï쳌¡ . that has been granted access is required to submit a report Thailand : PVPA , RFSRCFA , and APPTMI every four months and a government representative joins The Department of Agriculture and ï쳌² ï쳌¦ ï쳌¤ oversee the ï쳌° ï쳌¶ ï쳌° ï쳌¡ project scientists during every field visit . This project was and ï쳌² ï쳌¦ ï쳌³ ï쳌² ï쳌£ ï쳌¦ ï쳌¡ , respectively , but no monitoring structure has not required to submit an ï쳌¥ ï쳌© ï쳌¡ . been defined under these policies . However , the Prime Under the Wildlife Act , applicants have to pay an eco - Minister Regulation on the Conservation and Utilization logical or performance bond . The ï?? ï?? ï?? ï?? draft Guidelines for of Biological Diversity created a National Committee on Bioprospecting Activities ( see endnote ï?? ï?? ) state that the Conservation and Utilization of Biological Diversity that applicant must post a rehabilitation / performance bond , in is likely to address this issue . On the other hand , ï쳌² ï쳌¦ ï쳌³ ï쳌² ï쳌£ ï쳌¦ ï쳌¡ the form of a surety bond , in an amount equivalent to ï?? ï?? % states that every six months , bioprospectors must submit percent of the project cost as reflected in the research bud - three copies of a progress report to the ï쳌² ï쳌¦ ï쳌¤ . In addition , get . The bond would have to be posted within a reasonable bioprospectors that cause negative environmental impacts time after the signing of the Bioprospecting Undertaking . are liable and may be punished by Thai laws ( J . Donavanik , No collection of samples may be conducted until after the pers . comm . January ï?? ï?? ï?? ï?? ) . ï쳌¡ ï쳌° ï쳌° ï쳌´ ï쳌­ ï쳌© provides for the cre - bond has been posted and failure to post the bond can be a ation of an enforcement force of officials from the Ministry basis for rescission of the Bioprospecting Undertaking . of Public Health to enforce the provisions of the act . The Under the guidelines , reporting requirements are as follows : the resource user must submit an annual progress act also includes penalties such as prison sentences and report to the implementing agencies covering the follow - fines for breaches of the act ( ï쳌® ï쳌© ï쳌´ ï쳌´ ï쳌­ ï?? ï?? ï?? ï?? ) . ing items : a ) status of the procurement of ï쳌° ï쳌© ï쳌£ ; b ) progress USA : NPS research specimen collection permit of collection of samples ; c ) benefit - sharing negotiations ; There are at least three main routes by which ï쳌® ï쳌° ï쳌³ can use its d ) progress on payment of benefits or other provisions of enforcement authority : a ) regulations and related statutes ; the Bioprospecting Undertaking . The annual report must b ) permit provisions that include regulations and contracts ; be submitted not later than January ï?? ï?? of the following and c ) contracts . Collecting without a permit or poaching is year . For purposes of compliance monitoring , biopros - theft of Federal property and in this case criminal sanctions pectors must issue the following certifications as proof can apply . Failure to comply with regulations and permit of compliance , particularly on the proper procurement of provisions ( assuming a permit is issued ) can be less seri - ï쳌° ï쳌© ï쳌£ , delivery of benefit - sharing agreement , and collection ous ; administrative penalties ( possibly judicial ) can apply quota : proper procurement of ï쳌° ï쳌© ï쳌£ ; acceptance by resource ( including a punitive ï?? ï?? % mandatory â?? royalty â?쳌 payment providers of the monetary and nonmonetary benefits re - in the context of the Diversa / Yellowstone National Park quired by the undertaking ; and compliance to the collection agreement ) . If there is an agreement violation or breach of quota as set out in the undertaking . contract ; damages and injunctive relief can also apply . The Noncompliance with the provisions in the Bio - Diversa / Yellowstone National Park ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ also included prospecting Undertaking would result in the automatic audit clauses designed to promote compliance ( P . Scott , cancellation the agreement and confiscation of collected pers . comm . February ï?? ï?? ï?? ï?? ) . In addition , as part of the materials in favor of the government , forfeiture of bond research permit terms , scientists are required to submit a and imposition of a perpetual ban on access to biologi - yearly summary of their park research activities , known as cal resources in the Philippines by the violator . Such a an Investigatorâ??s Annual Report . In addition , the park may breach would be considered a violation of the Wildlife require copies of field notes and scientific publications ( see Act and would be subject to the imposition of adminis - Chapter ï?? ) . Besides , it may be that the potential negative trative and criminal sanctions under existing laws . Any publicity of being caught by the ï쳌® ï쳌° ï쳌³ is a significant deter - person who conducts bioprospecting without an approved rent itself ( P . Scott , pers . comm . December ï?? ï?? ï?? ï?? ) . Bioprospecting Undertaking would be subject to sanctions Analysis : Enforcement and Monitoring for collecting without a permit . Furthermore , the violation All countries analyzed above , except for Samoa , have would be published in national and international media and it would be reported by the agencies to the relevant proposed measures to ensure that bioprospecting projects ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : D ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¯ ï쳌¦ P ï쳌¯ ï쳌¬ ï쳌© ï쳌£ ï쳌© ï쳌¥ ï쳌³ ï쳌© ï쳌® P ï쳌¬ ï쳌¡ ï쳌£ ï쳌¥ ï쳌¡ ï쳌® ï쳌¤ ï쳌© ï쳌® P ï쳌² ï쳌¯ ï쳌§ ï쳌² ï쳌¥ ï쳌³ ï쳌³ comply with ï쳌¡ ï쳌¢ ï쳌³ regulations . However , none of these and blacklisted with the subsequent loss of reputation and monitoring mechanisms are operational yet . Not even the business opportunities in other countries . Philippines , which has granted access to a couple of bio - Most ï쳌¡ ï쳌¢ ï쳌³ policies may also require bioprospectors to prospecting projects under ï쳌¥ ï쳌¯ ï?? ï?? ï?? ( see Chapter ï?? ) , has a submit an ï쳌¥ ï쳌© ï쳌¡ to ensure that project activities will not have monitoring system up and running . This may be related to significant ecological , social , or economic impacts . Such the fact that setting up this kind of system is an expensive an assessment may provide baseline information that can endeavor . One strategy to finance monitoring activities is be used to monitor the evolution of ecological , social , or proposed by Nicaraguaâ??s draft Law of Biodiversity which economic conditions in sites where collections take place . requires access applicants to pay for an evaluation and However , so far no country has proposed standards , at monitoring system . This can be a practical and cost - effec - least about biodiversity indicators and other procedures tive measure as long as a third independent party runs the to monitor and evaluate the state of biological diversity system to ensure its objectivity . Others looking to ensure and its sustainable use . compliance may want to ask bioprospectors for a bond In the last decade , several indicator methodologies have as Peru and the Philippines propose in their national ï쳌¡ ï쳌¢ ï쳌³ been proposed to monitor the status of environmental is - policies . sues and biodiversity conservation efforts at the level of the In any case , the complexity of bioprospecting projects management of community and species ( N ï쳌¯ ï쳌³ ï쳌³ ï?? ï?? ï?? ï?? ) and at may make compliance and monitoring systems difficult to the provincial , national , regional , or global policy - making implement . Bioprospecting projects involve multiple activi - level ( ï쳌³ ï쳌¢ ï쳌³ ï쳌´ ï쳌´ ï쳌¡ ï?? ï?? ï?? ï?? ) . Perhaps the most popular methodol - ties that include : a ) collecting samples ; b ) processing and ogy for an environmental indicator system , among policy - shipping samples to research laboratories usually located makers and scientists , has been the so - called pressure , in foreign countries ; c ) analyzing samples ; d ) transferring state , response framework ( ï쳌³ ï쳌¢ ï쳌³ ï쳌´ ï쳌´ ï쳌¡ ï?? ï?? ï?? ï?? ) . According to samples between research organizations ; and e ) developing this framework , pressure indicators measure the forces that and commercializing products . This is an oversimplified development trends such as bioprospecting activities ( i.e . , description of a complex chain of events where multiple collection of biological samples and traditional knowledge ) actors interact with the samples and products derived from exert on the environment ; state indicators are those that them . Therefore , final products or processes may not have inform about the present quality and quantity of an envi - a physical connection with the genetic resource collected . ronmental variable ( i.e . , population size of species in the Products may have been manufactured from scratch based region where specimens are being collected or number of on the molecular structure of genetic resources collected . conflicts among local indigenous groups ) ; and response The samples may be stored in ex situ conservation centers indicators inform about the activities implemented to miti - for years before the appropriate technology is designed to gate a situation ( i.e . , reforestation or restoration projects take advantage of them . On the other hand , controlling or or conflict resolution meetings ) . Additional elements that prohibiting illegal access activities can be impossible . A a bioprospecting system of indicators should consider tourist can take samples back to his or her country with include : ï?? ) the type of information that should be col - almost no difficulty . The likelihood of catching such a lected by scientists for the indicators proposed , such as perpetrator is very slim . Furthermore , enforcement under number of species and hectares of habitat affected and ï?? ) statute is very complicated once the collector has left the the frequency of collection of this information that should area of jurisdiction . If a citizen of a country patents a prod - coincide with the workplan of a given bioprospecting proj - uct derived from a sample illegally collected in another ect . Information fed to the indicator system could also be country , the source country cannot compel anything to be manipulated to assess whether bioprospecting initiatives done to the citizen of the country that patented the sample . are complying with the Convention on Biological Diversity The collector , however , may be deterred by bad publicity and relevant access laws and policies . Final Comments The ï쳌£ ï쳌¢ ï쳌¤ â?? s provisions on access to genetic resources , tradi - are complemented by existing or future environmental , tional knowledge , technology transfer , and benefit sharing sustainable development , or biodiversity related laws ( Articles ï?? ( j ) , ï?? ï?? , ï?? ï?? , and ï?? ï?? ) are closely linked to ï쳌£ ï쳌¢ ï쳌¤ or policies . In any case , ï쳌¡ ï쳌¢ ï쳌³ laws and policies of these articles that address biodiversity conservation , sustainable countries aim at implementing the ï쳌£ ï쳌¢ ï쳌¤ and they share key use , monitoring , and capacity building objectives ( Articles similarities that include : a ) the establishment of bilateral ï?? , ï?? , ï?? , ï?? ï?? , ï?? ï?? , ï?? ï?? , ï?? ï?? , ï?? ï?? , ï?? ï?? , and ï?? ï?? ) . While countries agreements between bioprospecting groups and the na - such as Costa Rica and Nicaragua have established this tional government that must be negotiated on mutually connection directly through the design of comprehen - agreed terms ; b ) the recognition of national sovereignty sive single laws and policies that implement all of the over biological and genetic resources within national provisions of the ï쳌£ ï쳌¢ ï쳌¤ , other countries such as Australia , borders ; c ) the establishment of procedures for obtain - Colombia , Ecuador , Mexico , Peru , Philippines , Samoa , ing ï쳌° ï쳌© ï쳌£ from government authorities and the providers of and Thailand have developed single ï쳌¡ ï쳌¢ ï쳌³ regulations that samples and traditional knowledge ( except for Thailand ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ which requires ï쳌° ï쳌© ï쳌£ only from government authorities ) ; and indigenous peoples , and the conditions to facilitate access d ) the equitable sharing of benefits derived from the use to noncommercial bioprospecting activities . In contrast , of biological diversity . However , as expected , these laws Samoaâ??s ï쳌¡ ï쳌¢ ï쳌³ conditions consist of one page with an over - and policies also present several differences that are simply simplified proposal to facilitate access that will still need the result of different policy or regulatory options taken further clarification , but which is practical and refreshing . by countries and the expression of different legal systems , New proposals for ï쳌¡ ï쳌¢ ï쳌³ laws and polices are also dealing cultural beliefs , and social and economic conditions . For with similar issues and trying to resolve new ones ( e.g . , the example , countries with large percentages of indigenous ownership issue in Malaysia ) . In the ï쳌µ ï쳌³ ï쳌¡ , ï쳌® ï쳌° ï쳌³ regulations population are still trying to figure out strategies to protect are analogous to some of the provisions of ï쳌¡ ï쳌¢ ï쳌³ laws and indigenous knowledge . Furthermore , most of the countries policies that other countries have proposed and these ï쳌® ï쳌° ï쳌³ examined in this chapter are working on policies that show regulations facilitate ï쳌¡ ï쳌¢ ï쳌³ goals in ï쳌® ï쳌° ï쳌³ land . concern about the potential negative impact of on access In synthesis , ï쳌¡ ï쳌¢ ï쳌³ laws and policies developed under activities on the environment . the umbrella of the ï쳌£ ï쳌¢ ï쳌¤ have created a complex and com - This review also shows that most ï쳌¡ ï쳌¢ ï쳌³ laws and prehensive scenario for access and exchange of genetic polices are comprehensive , but sometimes confusing , resources . This is the result of a process marked with costly , and difficult to implement . They share provisions conceptual and operational concerns and difficulties that and principles that need further clarification . For example , still continue even for countries that pioneered ï쳌¡ ï쳌¢ ï쳌³ regula - countries such as Colombia , Peru , Ecuador , Costa Rica , tions in the mid - ï?? ï?? ï?? ï?? s . The next chapter examines these and the Philippines that have had ï쳌¡ ï쳌¢ ï쳌³ laws in place since issues and their influence on the development process of the mid - ï?? ï?? ï?? ï?? s are still trying to define the scope of their selected ï쳌¡ ï쳌¢ ï쳌³ laws and policies . access laws , the strategies to protect the knowledge of References A ï쳌® ï쳌¤ ï쳌¥ ï쳌¡ ï쳌® C ï쳌¯ ï쳌­ ï쳌­ ï쳌µ ï쳌® ï쳌© ï쳌´ ï쳌¹ . ï?? ï?? ï?? ï?? . Decision ï?? ï?? ï?? : Common Covenant and the isolation of anti - viral drug prostratin from a Samoan Medicinal Plant . Pharmaceutical Biology regime on access to genetic resources . http : / / ï?? ï?? ( Supplement ) : ï?? ï?? â?? ï?? ï?? . www.comunidadandina.org / ingles / treaties / dec / d ï?? ï?? ï?? e.htm . D ï쳌¡ ï쳌¶ ï쳌© ï쳌³ S . ï?? ï?? ï?? ï?? . Pathways to economic development through A ï쳌® ï쳌¤ ï쳌¥ ï쳌¡ ï쳌® C ï쳌¯ ï쳌­ ï쳌­ ï쳌µ ï쳌® ï쳌© ï쳌´ ï쳌¹ . ï?? ï?? ï?? ï?? . Decision ï?? ï?? ï?? : Common intellec - intellectual property rights . Environment Department , tual property regime . http : / / www.comunidadandina.org / World Bank , Washington ï쳌¤ ï쳌£ ï쳌µ ï쳌³ ï쳌¡ . ingles / treaties / dec / D ï?? ï?? ï?? e.htm . ï쳌¤ ï쳌¥ K ï쳌¬ ï쳌¥ ï쳌­ ï쳌­ C . ï?? ï?? ï?? ï?? . Conservation legislation . p . ï?? ï?? ï?? â?? ï?? ï?? ï?? in A ï쳌® ï쳌¤ ï쳌¥ ï쳌¡ ï쳌® C ï쳌¯ ï쳌­ ï쳌­ ï쳌µ ï쳌® ï쳌© ï쳌´ ï쳌¹ . ï?? ï?? ï?? ï?? . Decision ï?? ï?? ï?? : Regional D.R . G ï쳌© ï쳌¶ ï쳌¥ ï쳌® ( ed . ) Principles and practice of plant conser - biodiversity strategy for the tropical Andean countries . vation . Timber Press , ï쳌¯ ï쳌² ï쳌µ ï쳌³ ï쳌¡ . http : / / www.comunidadandina.org / ingles / treaties / dec / D ï?? ï?? ï?? e.htm . D ï쳌© ï쳌¶ ï쳌© ï쳌³ ï쳌© ï쳌¯ ï쳌® ï쳌¯ ï쳌¦ E ï쳌® ï쳌¶ ï쳌© ï쳌² ï쳌¯ ï쳌® ï쳌­ ï쳌¥ ï쳌® ï쳌´ ï쳌¡ ï쳌® ï쳌¤ C ï쳌¯ ï쳌® ï쳌³ ï쳌¥ ï쳌² ï쳌¶ ï쳌¡ ï쳌´ ï쳌© ï쳌¯ ï쳌® . ï?? ï?? ï?? ï?? . Government of Samoa : National report to the Convention A ï쳌® ï쳌¯ ï쳌® ï쳌¹ ï쳌­ ï쳌¯ ï쳌µ ï쳌³ . ï?? ï?? ï?? ï?? . ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ , biodiversity and traditional knowl - on Biological Diversity . Department of Lands , Survey , edge . Bridges ï?? ( ï?? ) : ï?? ï?? â?? ï?? ï?? . http : / / www.ictsd.org / . and Environment , Apia , Samoa . B ï쳌¡ ï쳌² ï쳌¢ ï쳌¥ ï쳌² C.V , L . G ï쳌¬ ï쳌¯ ï쳌· ï쳌« ï쳌¡ , and A.G.M . L ï쳌¡ V ï쳌© ï?± ï쳌¡ . ï?? ï?? ï?? ï?? . ï쳌¤ ï쳌¬ ï쳌³ ï쳌¥ . ï?? ï?? ï?? ï?? . Conditions for access to and benefit sharing of Developing and implementing national measures for Samoaâ??s biodiversity resources . Department of Lands , genetic resources access regulation and benefit - sharing . Surveys and Environment ( ï쳌¤ ï쳌¬ ï쳌³ ï쳌¥ ) , Government of Samoa . p ï?? ï?? ï?? â?? ï?? ï?? ï?? in S . L ï쳌¡ ï쳌© ï쳌² ï쳌¤ ( ed . ) Biodiversity and traditional knowledge : Equitable partnerships in practice . Earthscan , D ï쳌µ ï쳌´ ï쳌¦ ï쳌© ï쳌¥ ï쳌¬ ï쳌¤ G . ï?? ï?? ï?? ï?? . Intellectual property rights , trade and London , ï쳌µ ï쳌« . biodiversity . Earthscan . London , UK . G ï쳌¡ ï쳌£ ï쳌¥ ï쳌´ ï쳌¡ P ï쳌¡ ï쳌² ï쳌¬ ï쳌¡ ï쳌­ ï쳌¥ ï쳌® ï쳌´ ï쳌¡ ï쳌² ï쳌© ï쳌¡ . ï?? ï?? ï?? ï?? . Del Sen . Jorge Rubén C ï쳌¨ ï쳌¡ ï쳌¬ ï쳌¥ ï쳌² ï쳌­ ï쳌° ï쳌¯ ï쳌® ï쳌§ ï쳌³ ï쳌¥ A . ï?? ï?? ï?? ï?? . Access and benefit sharing relating Nordhausen González , del Grupo Parlamentario del to forest genetic resources and traditional knowledge Partido Acción Nacional , la que contiene iniciativa de Ley in Thailand . p . ï?? ï?? ï?? â?? ï?? ï?? ï?? in L . G ï쳌¬ ï쳌¯ ï쳌· ï쳌« ï쳌¡ , B . P ï쳌© ï쳌³ ï쳌µ ï쳌° ï쳌¡ ï쳌´ ï쳌© , para el acceso y aprovechamiento de los recursos biológi - and S . ï쳌¤ ï쳌¥ S ï쳌© ï쳌¬ ï쳌¶ ï쳌¡ ( eds . ) . Access to genetic resources and cos y genético . N . ï?? ï?? . Senado de la República , México . traditional knowledge : Lessons from South and Southeast http : / / camaradediputados.gob.mx / gaceta / . Asia . Proceedings of the South and Southeast Asia region - al workshop on access to genetic resources and traditional G ï쳌© ï쳌¦ ï쳌© ï쳌³ S.H . ï?? ï?? ï?? ï?? . Law Dictionary . Third edition . Barronâ??s knowledge , February ï?? ï?? ï?? ï?? . ï쳌© ï쳌µ ï쳌£ ï쳌® . Educational Series , New York , ï쳌® ï쳌¹ ï쳌µ ï쳌³ ï쳌¡ . ï쳌£ ï쳌¯ ï쳌© ï쳌£ ï쳌¡ . ï?? ï?? ï?? ï?? . Pueblos indígenas amazónicos rechazan el robo G ï쳌¬ ï쳌¯ ï쳌· ï쳌« ï쳌¡ L . ï?? ï?? ï?? ï?? . A guide to designing legal frameworks to y la privatización de sus conocimientos . Press Release , ï?? ï?? determine access to genetic resources . Environmental June . Coordinadora de las Organizaciones Indígenas de la Policy and Law paper No . ï?? ï?? . Environmental Law Center , Cuenca Amazónica , Quito , Ecuador . ï쳌© ï쳌µ ï쳌£ ï쳌® , Gland , Switzerland , Cambridge , and Bonn . C ï쳌¯ ï쳌² ï쳌² ï쳌¥ ï쳌¡ C.M . ï?? ï?? ï?? ï?? . Access to plant genetic resources and G ï쳌² ï쳌¡ ï쳌ª ï쳌¡ ï쳌¬ A . ï?? ï?? ï?? ï?? . Biodiversity and the nation state : Regulating intellectual property rights . Background study paper access to genetic resources limits biodiversity research in No . ï?? . Commission on Genetic Resources for Food and developing countries . Conservation Biology ï?? ï?? ( ï?? ) : ï?? â?? ï?? . Agriculture , ï쳌¦ ï쳌¡ ï쳌¯ , Rome , Italy . ï쳌© ï쳌® ï쳌² ï쳌¥ ï쳌® ï쳌¡ . ï?? ï?? ï?? ï?? . Proyecto de reglamento sobre acceso a los re - C ï쳌¯ ï쳌¸ P.A . ï?? ï?? ï?? ï?? . Ensuring equitable benefits : The Falealupo cursos genéticos . Instituto Nacional de Recursos Naturales ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : D ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¯ ï쳌¦ P ï쳌¯ ï쳌¬ ï쳌© ï쳌£ ï쳌© ï쳌¥ ï쳌³ ï쳌© ï쳌® P ï쳌¬ ï쳌¡ ï쳌£ ï쳌¥ ï쳌¡ ï쳌® ï쳌¤ ï쳌© ï쳌® P ï쳌² ï쳌¯ ï쳌§ ï쳌² ï쳌¥ ï쳌³ ï쳌³ ( ï쳌© ï쳌® ï쳌² ï쳌¥ ï쳌® ï쳌¡ ) , Ministerio de Agricultura , Lima , Perú . ï쳌³ ï쳌¢ ï쳌³ ï쳌´ ï쳌´ ï쳌¡ . ï?? ï?? ï?? ï?? . Recommendations for a core set of indica - tors . Subsidiary Body on Scientific , Technical and L ï쳌¡ A ï쳌³ ï쳌¡ ï쳌­ ï쳌¢ ï쳌¬ ï쳌¥ ï쳌¡ L ï쳌¥ ï쳌§ ï쳌© ï쳌³ ï쳌¬ ï쳌¡ ï쳌´ ï쳌© ï쳌¶ ï쳌¡ . ï?? ï?? ï?? ï?? . Ley No . ï?? ï?? ( de I de julio de ï?? ï?? ï?? ï?? ) : Ley general de ambiente de la Republica de Technological Advice ( ï쳌³ ï쳌¢ ï쳌³ ï쳌´ ï쳌´ ï쳌¡ ) , Convention on Biological Panamá . Diario Oficial No . ï?? ï?? , ï?? ï?? ï?? , Panamá . Diversity . ï쳌µ ï쳌² ï쳌¬ : http : / / www.biodiv.org / doc / meetings / ï쳌­ ï쳌¡ ï쳌² ï쳌¥ ï쳌® ï쳌¡ . ï?? ï?? ï?? ï?? . Ley General del Medio Ambiente y los sbstta / sbstta - ï?? ï?? / information / sbstta - ï?? ï?? - inf - ï?? ï?? - en.htm . Recursos Naturales - Ley No . ï?? ï?? ï?? . Ministerio del ï쳌³ ï쳌¥ ï쳌­ ï쳌¡ ï쳌² ï쳌® ï쳌¡ ï쳌´ . ï?? ï?? ï?? ï?? . Ley General de Vida Silvestre . Secretaría Ambiente y los Recursos Naturales ( ï쳌­ ï쳌¡ ï쳌² ï쳌¥ ï쳌® ï쳌¡ ) , Managua , de Medio Ambiente y Recursos Naturales ( ï쳌³ ï쳌¥ ï쳌­ ï쳌¡ ï쳌² ï쳌® ï쳌¡ ï쳌´ ) , Nicaragua , http : / / www.marena.gob.ni / normas_ Diario Oficial , Ciudad de México , México . procedimientos ï?? ï?? . htm . ï쳌³ ï쳌¥ ï쳌­ ï쳌¡ ï쳌² ï쳌® ï쳌¡ ï쳌´ . ï?? ï?? ï?? ï?? . Ley General de Desarrollo Forestal . ï쳌­ ï쳌¡ ï쳌² ï쳌¥ ï쳌® ï쳌¡ . ï?? ï?? ï?? ï?? . Proyecto de Ley de Biodiversidad . Ministerio Secretaría de Medio Ambiente y Recursos Naturales del Ambiente y los Recursos Naturales ( ï쳌­ ï쳌¡ ï쳌² ï쳌¥ ï쳌® ï쳌¡ ) , ( ï쳌³ ï쳌¥ ï쳌­ ï쳌¡ ï쳌² ï쳌® ï쳌¡ ï쳌´ ) , Diario Oficial , Ciudad de México , México . Managua , Nicaragua . S ï쳌£ ï쳌¨ ï쳌· ï쳌¥ ï쳌© ï쳌´ ï쳌º ï쳌¥ ï쳌² J . , F.G . H ï쳌¡ ï쳌® ï쳌¤ ï쳌¬ ï쳌¥ ï쳌¹ , J . E ï쳌¤ ï쳌· ï쳌¡ ï쳌² ï쳌¤ ï쳌³ , W.F . H ï쳌¡ ï쳌² ï쳌² ï쳌© ï쳌³ , ï쳌® ï쳌© ï쳌´ ï쳌´ ï쳌­ . ï?? ï?? ï?? ï?? . Act on the Protection and Promotion of M.R . G ï쳌² ï쳌¥ ï쳌¶ ï쳌¥ ï쳌² , S.A . S ï쳌£ ï쳌¨ ï쳌¥ ï쳌° ï쳌¡ ï쳌² ï쳌´ ï쳌º , G . C ï쳌² ï쳌¡ ï쳌§ ï쳌§ , K . Traditional Thai Medicinal Intelligence , B.E . ï?? ï?? ï?? ï?? . S ï쳌® ï쳌¡ ï쳌¤ ï쳌¥ ï쳌² , A . B ï쳌¨ ï쳌¡ ï쳌´ . ï?? ï?? ï?? ï?? . Commentary : Summary of the National Institute of Thai Traditional Medicine , Office of the Permanent Secretariat , Ministry of Public Health , Workshop on Drug Development , Biological Diversity , Book Development Project , The Thai Traditional and Economic Growth . Journal of the National Cancer Medicine Foundation . Bangkok , Thailand . Institute ï?? ï?? ( ï?? ï?? ) : ï?? ï?? ï?? ï?? â?? ï?? ï?? ï?? ï?? . N ï쳌¯ ï쳌³ ï쳌³ R.F . ï?? ï?? ï?? ï?? . Indicators for monitoring biodiversity : A hier - S ï쳌¨ ï쳌© ï쳌¶ ï쳌¡ V . ï?? ï?? ï?? ï?? . Patents : Myth or reality . Penguin Group . ï쳌µ ï쳌³ ï쳌¡ . archical approach . Conservation Biology ï?? ( ï?? ) : ï?? ï?? ï?? â?? ï?? ï?? ï?? . ï쳌´ ï쳌¥ ï쳌® K ï쳌¡ ï쳌´ ï쳌¥ T.K . and S.A . L ï쳌¡ ï쳌© ï쳌² ï쳌¤ . ï?? ï?? ï?? ï?? . The commercial use O ï쳌¬ ï쳌¤ ï쳌¦ ï쳌© ï쳌¥ ï쳌¬ ï쳌¤ M . L . ï?? ï?? ï?? ï?? . The value of conserving genetic re - of biodiversity : Access to genetic resources and benefit - sources . Sinauer Associates , Inc . , Sunderland , ï쳌­ ï쳌¡ ï쳌µ ï쳌³ ï쳌¡ . sharing . Earthscan . London , ï쳌µ ï쳌« . P ï쳌¥ ï쳌² ï쳌µ ï쳌¶ ï쳌© ï쳌¡ ï쳌® C ï쳌¯ ï쳌® ï쳌§ ï쳌² ï쳌¥ ï쳌³ ï쳌³ . ï?? ï?? ï?? ï?? . Ley que establece el régimen T ï쳌¨ ï쳌¡ ï쳌© ï쳌¬ ï쳌¡ ï쳌® ï쳌¤ C ï쳌¯ ï쳌® ï쳌§ ï쳌² ï쳌¥ ï쳌³ ï쳌³ . ï?? ï?? ï?? ï?? . Plant Variety Protection Act . de protección de los conocimientos colectivos de los Government Gazette , Vol . ï?? ï?? ï?? , Part ï?? ï?? ï?? a , ï?? ï?? November . pueblos indígenas vinculados a los resguardos biológicos . Thailand . Poder Legislativo Congreso de la Republica , Ley ï?? ï?? ï?? ï?? ï?? , V ï쳌¯ ï쳌µ ï쳌­ ï쳌¡ ï쳌² ï쳌¤ J . ï?? ï?? ï?? ï?? . Access to biological resources in Lima , Perú . ï쳌µ ï쳌² ï쳌¬ : http : / / www.concytec.gob.pe / infocyt / ley ï?? ï?? ï?? ï?? ï?? . html . Commonwealth areas . Commonwealth of Australia . P ï쳌© ï쳌® ï쳌¨ ï쳌¥ ï쳌© ï쳌² ï쳌¯ C.U.B . ï?? ï?? ï?? ï?? . Jaborandi ( Pilocarpus sp . , Rutaceae ) : Canberra , Australia . A wild species and its rapid transformation into a crop . Economic Botany ï?? ï?? ( ï?? ) : ï?? ï?? â?? ï?? ï?? . Endnotes 1 ï쳌´ ï쳌¥ ï쳌® K ï쳌¡ ï쳌´ ï쳌¥ and L ï쳌¡ ï쳌© ï쳌² ï쳌¤ ( ï?? ï?? ï?? ï?? ) report that the following ï?? ï?? countries , communities , and farmers and breeders , and for the regulation of access to biological resources â?쳌 is another example of this type of which are Parties to the CBD , and the United States of America , regional initiatives . which is a signatory , but not a Party , have developed or are developing access and benefit - sharing frameworks : Argentina , 7 Between April ï?? ï?? ï?? ï?? and May ï?? ï?? ï?? ï?? Venezuela has invoked Australia ( at the Commonwealth level and in the states of Western Decision ï?? ï?? ï?? to facilitate access to ï?? ï?? projects and has subscribed Australia and Queensland ) , Belize , Bolivia , Brazil , Cameroon , five framework agreements with national universities and research Colombia , Costa Rica , Ecuador , Eritrea , Ethiopia , Fiji , The centers to carry out bioprospecting activities for noncommercial Gambia , Ghana , Guatemala , India , Indonesia , Kenya , Lao Peopleâ??s purposes ( M.E . Febres , Pers . Comm . May ï?? ï?? ï?? ï?? ) . Under Decision Democratic Republic , Lesotho , Malawi , Malaysia ( including the ï?? ï?? ï?? , a university , research center , or scientist that subscribes a State of Sarawak ) , Mexico , Mozambique , Namibia , Nigeria , Papua framework agreement with the government is allowed to carry out New Guinea , Peru , Philippines , the Republic of Korea , Samoa , several projects under such agreement . Seychelles , Solomon Islands , South Africa , Tanzania , Thailand , 8 In this chapter bioprospecting is defined as the search for plants , Turkey , Venezuela , Vietnam , Yemen , and Zimbabwe . animals , and microbial species for academic , pharmaceutical , 2 See the ï쳌£ ï쳌¢ ï쳌¤ website for a roster of country status with re - biotechnological , agricultural , and other industrial purposes . spect to signing and becoming a Party to the ï쳌£ ï쳌¢ ï쳌¤ , ï쳌µ ï쳌² ï쳌¬ : http : 9 ï쳌¡ ï쳌® ï쳌¡ ï쳌­ regulates access to wildlife genetic resources and the / / www.biodiv.org / world / parties.asp . National Institute for Agricultural Research ( ï쳌© ï쳌¤ ï쳌© ï쳌¡ ï쳌° ) controls access 3 All of the countries that developed these access and benefit - sharing to agricultural genetic resources ( M . Dimas , pers . comm . August frameworks are still working to improve their laws or to turn their ï?? ï?? ï?? ï?? ) . policies or administrative measures into laws ( see Chapter ï?? ) . 10 Draft Guidelines for Bioprospecting Activities in the Philippines 4 The Andean Community ( formerly known as the Andean Pact or ( Joint ï쳌¤ ï쳌¥ ï쳌® ï쳌² - ï쳌¤ ï쳌¡ - ï쳌° ï쳌£ ï쳌³ ï쳌¤ - ï쳌® ï쳌£ ï쳌© ï쳌° Administrative Order No . ï?? ) . Available Cartagena Accord ) is an economic and social - integration treaty at ï쳌µ ï쳌² ï쳌¬ : http : / / www.denr.gov.ph / article / view / ï?? ï?? ï?? ï?? / . among Colombia , Peru , Ecuador , Venezuela , and Bolivia . 11 ï쳌µ ï쳌² ï쳌¬ : http : / / www.med.govt.nz / ers / nat - res / bioprospecting / 5 The Association of Southeast Asian Nations or ï쳌¡ ï쳌³ ï쳌¥ ï쳌¡ ï쳌® is a regional index.html . organization that promotes economic growth , social progress , 12 The situation in Australian States and Territories is not consistent and cultural development in the region . Its member countries are or clear . Resolving ownership issues in some states may well be Indonesia , Malaysia , Philippines , Singapore , Thailand , Brunei controversial . Complicating the issue is that some people confuse Darussalam , Laos , Myanmar , and Cambodia . ownership of biochemical and genetic material from individual 6 The â?? African model law for the protection of the rights of local examples of species with ownership of the species as a whole . ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ 21 Furthermore , there is the misconception held by some people that ï쳌µ ï쳌² ï쳌¬ : http : / / www.nrct.net / modules.php ? op = modload & name = Sectio the patent system somehow allows a patentee to assert control ns & file = index & req = viewarticle & artid = ï?? ï?? ï?? . over the possession and use of biological resources from which 22 ï쳌µ ï쳌² ï쳌¬ : http : / / science.nature.nps.gov / research . the patented invention has been derived ( G . Burton , pers . comm . 23 G ï쳌© ï쳌¦ ï쳌© ï쳌³ ( ï?? ï?? ï?? ï?? ) defines a contract as â?? a promise or a set of promises , January ï?? ï?? ï?? ï?? ) . for breach of which the law gives a remedy , or the performance of 13 Customary land is held and used according to custom and it is which the law in some cases recognizes as a duty â?쳌 . owned by a family , clan , or tribe ( C . Schuster , pers . comm . August 24 ï?? ï?? ï?? ï?? ) . Several academic or scientific projects ( noncommercial ) can be 14 included in one framework access contract ( P ï쳌¥ ï쳌² ï쳌µ ï쳌¶ ï쳌© ï쳌¡ ï쳌® C ï쳌¯ ï쳌® ï쳌§ ï쳌² ï쳌¥ ï쳌³ ï쳌³ Full text of the ï쳌© ï쳌´ ï쳌° ï쳌§ ï쳌² ï쳌¦ ï쳌¡ and its Annex are available at ï쳌µ ï쳌² ï쳌¬ : ftp : / / ext - ftp.fao.org / waicent / pub / cgrfa ï?? / iu / ITPGRe.pdf . ï?? ï?? ï?? ï?? ) . 15 25 Natural resources are defined as living and nonliving resources A local domestic plant variety is one that exists only in a particular that include â?? soil , rock , sand , nutrients , water , air , forest , plants , locality within the country and has never been registered as a new animals , insects , microorganisms , and living residues â?쳌 ; biological plant variety and which is registered as a local domestic plant resources are defined as â?? any living resources within the forested variety under this Act . area â?쳌 and genetic resources include â?? genetic units â?쳌 and â?? different 26 A general domestic plant variety refers to any plant variety origi - forms of genes â?쳌 . nating or existing in the country and commonly exploited and shall 16 The ï쳌¥ ï쳌° ï쳌¢ ï쳌£ ï쳌¡ ï쳌² currently provides for reserve and wildlife permits : include a plant variety which is not a new plant variety , a local a ) reserve permits are for activities in Commonwealth areas that domestic plant variety , or a wild plant variety . include reserves , parks , conservation zones , and external territories ; 27 and b ) wildlife permits are for taking , keeping , and moving listed A wild plant variety refers to one that currently exists or used to threatened migratory , marine , and cetacean species and communi - exist in the natural habitat and has not been commonly cultivated . ties in Commonwealth areas ( V ï쳌¯ ï쳌µ ï쳌­ ï쳌¡ ï쳌² ï쳌¤ ï?? ï?? ï?? ï?? ) . 28 A ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ is defined by the Federal Technology Transfer Act 17 Bioprospectors may find that there can be several access providers ; ( ï쳌¦ ï쳌´ ï쳌´ ï쳌¡ ) of ï?? ï?? ï?? ï?? as â?? any agreement between one or more Federal for example , if a Commonwealth area is subject to native title , the laboratories and one or more non - Federal parties under which the Commonwealth and the native titleholders are both access provid - Government , through its laboratories , provides personnel , services , ers . If the access provider is the Commonwealth , the Secretary to facilities , equipment , or other resources with or without reimburse - the Commonwealth department that has administrative authority ment ( but not funds to non - Federal parties ) and the non - Federal for the Commonwealth area may , on behalf of the Commonwealth , parties provide funds , personnel , services , facilities , equipment , enter into the benefit - sharing agreement ( see Chapter ï?? ) . or other resources toward the conduct of specified research or 18 This is a draft bylaw of the Law of Biodiversity that was approved development efforts which are consistent with the mission of the on ï?? ï?? December ï?? ï?? ï?? ï?? . laboratory â?쳌 ( see Chapter ï?? ) . 19 According to the Law of Biodiversity public universities were 29 The complete text and annexes of the ï쳌£ ï쳌¢ ï쳌¤ are available at http : exempted from control for a term of one year ( until ï?? May ï?? ï?? ï?? ï?? ) / / www.biodiv.org / convention / articles.asp . in order for them to establish their own controls and regulations for noncommercial projects that require access . So far only the 30 The complete text and annexes of the ï쳌£ ï쳌¢ ï쳌¤ are available at http : University of Costa Rica has developed access controls and regula - / / www.biodiv.org / convention / articles.asp . tions . This is due to the fact that the law is not currently under 31 For further information about the law relating to the patenting of implementation ( J . Cabrera , pers . comm . January ï?? ï?? ï?? ï?? ) . However , plants , microorganisms , and related biological materials , see ï쳌© ï쳌° once the constitutional challenge is resolved , universities will have to develop these access controls and regulations in a predetermined Australiaâ??s website at http : / / www.ipaustralia.gov.au / . period of time . Otherwise they will have to comply with the Law of 32 ï쳌µ ï쳌² ï쳌¬ : http : / / ip.aaas.org / tekindex.nsf . Biodiversity just like commercial bioprospectors . 33 The complete text and annexes of the ï쳌£ ï쳌¢ ï쳌¤ are available at http : 20 If the ï쳌´ ï쳌¯ authorizes the continuing use of genetic material or of / / www.biodiv.org / convention / articles.asp . biochemical extracts for commercial purposes , applicants are 34 Regulation ï?? A . ï?? ï?? . of the Crimes Act ; a penalty unit is currently set required to obtain a separate concession from the provider of the resource . The Law of Biodiversity does not provide information at ï?? ï?? ï?? ï?? ï쳌¡ ï쳌µ ï쳌¤ . about the process , requirements , and length of time needed to obtain this concession . ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : D ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¯ ï쳌¦ P ï쳌¯ ï쳌¬ ï쳌© ï쳌£ ï쳌© ï쳌¥ ï쳌³ ï쳌© ï쳌® P ï쳌¬ ï쳌¡ ï쳌£ ï쳌¥ ï쳌¡ ï쳌® ï쳌¤ ï쳌© ï쳌® P ï쳌² ï쳌¯ ï쳌§ ï쳌² ï쳌¥ ï쳌³ ï쳌³ Table ï?? . Access and benefit sharing ( ï쳌¡ ï쳌¢ ï쳌³ ) policy status of Pacific Rim countries signing the ï쳌£ ï쳌¢ ï쳌¤ Biological and Genetic Resources in the Philippines , their A . Countries with ABS laws and policies By - Products and Derivatives for Scientific and Commercial ï?? . Colombia Purposes and for other Purposes â?쳌 . In ï?? ï?? ï?? ï?? , the Philippines As a member of the Andean Community , Colombia is subject enacted Republic Act No . ï?? ï?? ï?? ï?? , also known as the Wildlife to the ï?? ï?? ï?? ï?? Decision ï?? ï?? ï?? on ï쳌¡ ï쳌¢ ï쳌³ , a regional law , and is cur - Resources and Conservation Act that addressed many of the rently working on a policy to facilitate implementation of criticisms made to the Executive Order ï?? ï?? ï?? . This Act includes Decision ï?? ï?? ï?? at a national level . only two clauses about bioprospecting issues but it modi - ï?? . Costa Rica fies Executive Order ï?? ï?? ï?? considerably . In July ï?? ï?? ï?? ï?? , draft In ï?? ï?? ï?? ï?? , Costa Rica enacted the Law of Biodiversity No . ï?? ï?? ï?? ï?? . â?? Guidelines for Bioprospecting Activities in the Philippines â?쳌 In late ï?? ï?? ï?? ï?? , the Attorney General of the Republic challenged was released for review and comment by the Department of the law , which prevented its implementation . In December Environment and Natural Resources . If adopted , the guidelines ï?? ï?? ï?? ï?? , a â?? General Access Procedure â?쳌 that will operate as the would facilitate the implementation of the Wildlife Act and bylaw of the Law of Biodiversity was published . Before the those provisions of ï쳌¥ ï쳌¯ ï?? ï?? ï?? not repealed by the Wildlife Act . development of this law , there were some provisions in the The Philippines has also been actively leading the development ï?? ï?? ï?? ï?? Law of Wildlife Conservation ( and its ï?? ï?? ï?? ï?? regulation ) of the ï쳌¡ ï쳌³ ï쳌¥ ï쳌¡ ï쳌® Framework on Access to Biological and Genetic regarding flora and fauna collection permits . There were also Resources that is scheduled to be adopted in ï?? ï?? ï?? ï?? or ï?? ï?? ï?? ï?? . some bylaws dealing with research , specifically referring to ï?? . Peru national parks . As a member of the Andean Community , Peru is subject to ï?? . Ecuador the ï?? ï?? ï?? ï?? Decision ï?? ï?? ï?? on ï쳌¡ ï쳌¢ ï쳌³ , a regional law . Peru has a As a member of the Andean Community , Ecuador is subject draft regulation for Decision ï?? ï?? ï?? that is being reviewed by to the ï?? ï?? ï?? ï?? Decision ï?? ï?? ï?? on ï쳌¡ ï쳌¢ ï쳌³ , a regional law . In ï?? ï?? ï?? ï?? , a the National Environmental Council . The government is also law for the protection of biodiversity was passed by Congress . developing a second regulation targeted to facilitate access to The law includes only one article that determines the Stateâ??s genetic resources found in indigenous land . In August ï?? ï?? ï?? ï?? , ownership of biological species as national and public goods . Peru adopted Law No . ï?? ï?? ï?? ï?? ï?? for the protection of indigenous This article also states that the commercial exploitation of communities â?? collective knowledge associated with biodiver - these species will be subject to special regulations issued by sity . the President that will guarantee the rights of indigenous com - munities over their knowledge and genetic resources . Ecuador ï?? . Samoa is also working on a draft regulation of Decision ï?? ï?? ï?? that has In ï?? ï?? ï?? ï?? , Samoa adopted the â?? Conditions for access to and been in the making since the ratification of Decision ï?? ï?? ï?? . A benefit sharing of Samoaâ??s Biodiversity Resources â?쳌 . This is final draft was submitted in April ï?? ï?? ï?? ï?? to the Minister of the a regulation that is being implemented to facilitate access , Environment . That draft received much criticism and was not while the country completes a draft bioprospecting regulation . approved by the Minister . There are also general provisions in However , further progress on this regulation is on hold until the pending new draft National Law for the Conservation and the Department of Lands , Surveys and Environment completes Sustainable Use of Biodiversity debated by Congress in April a review of the ï?? ï?? ï?? ï?? Lands , Surveys , and Environment Act . ï?? ï?? ï?? ï?? and February ï?? ï?? ï?? ï?? . The draft law is still under discussion The draft bioprospecting regulation is expected to be appended among government officials ( July ï?? ï?? ï?? ï?? ) . to the Act . ï?? . Thailand ï?? . Mexico ï쳌¡ ï쳌¢ ï쳌³ is regulated by the following two laws and two regu - Articles ï?? ï?? and ï?? ï?? ï쳌¢ ï쳌© ï쳌³ of the Ecological Equilibrium and lations : The ï?? ï?? ï?? ï?? Plant Variety Protection Act , the ï?? ï?? ï?? ï?? Environmental Protection General Act ( ï쳌¥ ï쳌¥ ï쳌¥ ï쳌° ï쳌§ ï쳌¡ ) regulate Act on Protection and Promotion of Traditional Medicinal ï쳌¡ ï쳌¢ ï쳌³ issues in Mexico . This law incorporates the three main Intelligence Act , the ï?? ï?? ï?? ï?? Royal Forest Department principles stated in the Convention on Biological Diversity Regulation on Forestry Studying and Research Conducting ( ï쳌£ ï쳌¢ ï쳌¤ ) : prior informed consent , mutually agreed terms , and within Forested Areas , and the ï?? ï?? ï?? ï?? Regulation on the benefit sharing . The ï쳌¥ ï쳌¥ ï쳌¥ ï쳌° ï쳌§ ï쳌¡ is complemented by a norm Permission of Foreign Researchers of the National Research ( ï쳌® ï쳌¯ ï쳌­ - ï?? ï?? ï?? - ï쳌¥ ï쳌£ ï쳌¯ ï쳌¬ - ï?? ï?? ï?? ï?? ) that facilitates a change of purpose Council of Thailand . from scientific ( or noncommercial ) to biotechnological ( or commercial ) uses . The ï?? ï?? ï?? ï?? Wildlife General Act ( ï쳌· ï쳌§ ï쳌¡ ) and ï?? . United States of America ( USA ) the ï?? ï?? ï?? ï?? Sustainable Forestry Development Act ( ï쳌³ ï쳌¦ ï쳌¤ ï쳌§ ï쳌¡ ) regu - The USA signed the ï쳌£ ï쳌¢ ï쳌¤ but it has not ratified it yet . Access late the collection of wildlife and forest biological resources to natural resources in the United States is ordinarily managed respectively . ï쳌¥ ï쳌¥ ï쳌¥ ï쳌° ï쳌§ ï쳌¡ , ï쳌· ï쳌§ ï쳌¡ , and ï쳌³ ï쳌¦ ï쳌¤ ï쳌§ ï쳌¡ set the principles but by the private or public owner of the resource . For example , not the details that should regulate ï쳌¡ ï쳌¢ ï쳌³ initiatives . There are access to genetic resources found in national parks is gov - two ï쳌¡ ï쳌¢ ï쳌³ law proposals in the Federal Congress that pur - erned by the National Park Service ( ï쳌® ï쳌° ï쳌³ ) regulations . Since port to fill this gap : one submitted by Federal Senator Jorge ï?? ï?? ï?? ï?? , the ï쳌® ï쳌° ï쳌³ has issued permits to facilitate the collection Nordhausen ( National Action Party ) , and another submitted by of specimens , and Cooperative Research and Development Federal Representative Alejandro Cruz Gutierrez ( Institutional Agreements ( ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ s ) can be used to address benefit - sharing Revolutionary Party ) . So far Congress has not discussed these issues . A ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ is defined by the Federal Technology Transfer laws in the plenary . Act of ï?? ï?? ï?? ï?? as â?? any agreement between one or more Federal ï?? . Philippines laboratories and one or more non - Federal parties under which In ï?? ï?? ï?? ï?? , the Philippines adopted the first ï쳌¡ ï쳌¢ ï쳌³ policy in the the Government , through its laboratories , provides person - world , Executive Order ï?? ï?? ï?? â?? Prescribing Guidelines and nel , services , facilities , equipment , or other resources with or Establishing a Regulatory Framework for the Prospecting of without reimbursement ( but not funds to non - Federal parties ) ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ Table ï?? . Continued and the non - Federal parties provide funds , personnel , services , legal instruments to regulate access to genetic resources and to ensure the fair participation in and equitable distribution of facilities , equipment , or other resources toward the conduct of benefits derived from their use . specified research or development efforts which are consistent with the mission of the laboratory â?쳌 . ï?? . China China , like many other countries , has policies that regulate B . Countries working towards the development of ABS access to genetic resources , but these policies lack benefit - laws and policies sharing provisions . However , Chinaâ??s ï?? ï?? ï?? ï?? National Report on Implementation of the Convention on Biological Diversity ï?? . Australia states that a priority action for the country is to draft a genetic The draft Environment Protection and Biodiversity resources policy or law that regulates prior informed consent Conservation Amendment Regulations are expected to be principles , benefit - sharing issues , and intellectual prop - enacted in ï?? ï?? ï?? ï?? and they will go under section ï?? ï?? ï?? ( Control erty rights , among other issues . So , in late ï?? ï?? ï?? ï?? , the State of access to biological resources ) of the ï?? ï?? ï?? ï?? Environment Council of China authorized the Environmental Protection Protection and Biodiversity Conservation Act . These regula - Administration ( ï쳌³ ï쳌¥ ï쳌° ï쳌¡ ) to coordinate all ï쳌¡ ï쳌¢ ï쳌³ - related issues tions will apply only to the â?? commonwealth area â?쳌 of the to ensure the implementation of the ï쳌£ ï쳌¢ ï쳌¤ . Therefore , ï쳌³ ï쳌¥ ï쳌° ï쳌¡ is country . The states and territories are also working on their currently leading a national project to inventory all genetic own ï쳌¡ ï쳌¢ ï쳌³ regulations . For example , in mid - ï?? ï?? ï?? ï?? , Queensland resources in China . This includes the participation of experts passed a Biodiscovery Bill and Western Australia is currently from many organizations and universities from the agriculture , discussing a licensing regime for terrestrial bioprospect - forestry , fishery , and medical sectors . Also , ï쳌³ ï쳌¥ ï쳌° ï쳌¡ is assembling ing activities that will be included in a draft Biodiversity a team to develop a comprehensive ï쳌¡ ï쳌¢ ï쳌³ policy or law . Conservation Act . In addition to this , in ï?? ï?? ï?? ï?? the Natural Resource Management Ministerial Council adopted a federal ï?? . Cook Islands agreement on a â?? Nationally Consistent Approach For Access The country is currently working on a national ï쳌¡ ï쳌¢ ï쳌³ policy that to and the Utilization of Australiaâ??s Native Genetic and will go under a proposed National Environmental Act . Central Biochemical Resources â?쳌 to facilitate the development ï쳌¡ ï쳌¢ ï쳌³ government ministries regulate national laws such as this act . regulations nationwide . The island councils of the different inhabited islands and the municipal councils for the capital island may adopt by - laws . ï?? . Cambodia These by - laws are managed under the Island Council . In ï?? ï?? ï?? ï?? Cambodia adopted a new Forestry Law . While this law is not specific about regulating ï쳌¡ ï쳌¢ ï쳌³ issues in relation ï?? . El Salvador to forest genetic resources , it regulates the commercial and In El Salvador there is no integral biodiversity law or strategy noncommercial use of timber that is extracted from all forests that regulates the use of and access to genetic , biological , and ( natural and planted ) , including wild vegetation , wildlife prod - biochemical resources . The current legal framework for the ucts , and services provided by the forest . Also , in ï?? ï?? ï?? ï?? , the regulation of access to genetic resources is partially covered Ministry of Environment made public the countryâ??s National by some laws . For example , Article ï?? ï?? of the Environmental Biodiversity Strategy and Action Plan . This document does not Law states that any access , research , manipulation , and use address the need to develop a comprehensive ï쳌¡ ï쳌¢ ï쳌³ policy , but it of biological diversity can only be carried out with a permit , states as one of its goals to ensure the equitable sharing of ben - license , or concession granted by the authority in charge of efits from the protection and sustainable use of biological re - managing the resource in question . Every time this permit is sources . Furthermore , the strategy and action plan emphasizes granted relevant communities have to be consulted . In ï?? ï?? ï?? ï?? , that existing legislation concerning biodiversity conservation however the Environment Ministry developed policy guide - and sustainable use is currently under revision in Cambodia . lines , administrative procedures , and a capacity - building strategy on access to genetic and biochemical resources . This ï?? . Canada information is currently being reviewed by the Presidency and No official decision has been made as to whether Canada constitutes the foundation for a national policy on access to should have an ï쳌¡ ï쳌¢ ï쳌³ policy . However , this country has un - genetic and biochemical resources that must be adopted by the dertaken some background research on ï쳌¡ ï쳌¢ ï쳌³ issues and held government in ï?? ï?? ï?? ï?? or ï?? ï?? ï?? ï?? . preliminary discussions with the provinces , some aboriginal groups and stakeholders on ï쳌¡ ï쳌¢ ï쳌³ issues , especially with respect ï?? . Fiji to the negotiation of the ï쳌£ ï쳌¢ ï쳌¤ Bonn Guidelines on ï쳌¡ ï쳌¢ ï쳌³ . The There is no legal or administrative framework in place on ï쳌¡ ï쳌¢ ï쳌³ . National Biodiversity Convention Office has been consulting There is a draft administrative paper that forms the basis of an aboriginal people on the Bonn Guidelines . unwritten understanding between all stakeholders on the issue of ï쳌¡ ï쳌¢ ï쳌³ . A national committee is also working on the develop - ï?? . Chile ment of an ï쳌¡ ï쳌¢ ï쳌³ policy . Committee members include scientists In late ï?? ï?? ï?? ï?? , Chile concluded a proposal for a law to regulate at the local University of the South Pacific and legal officers access to agricultural genetic resources . This proposal was from the state law office . developed by the Ministry of Agriculture without the partici - pation of all sectors of society and the government and it was ï?? . Guatemala discarded after much criticism . However , efforts to develop a The ï?? ï?? ï?? ï?? Action Plan of the National Strategy for the new proposal continue within the Ministry . In December ï?? ï?? ï?? ï?? , Conservation and Sustainable Use of Biodiversity states the the National Commission of the Environment ( ï쳌£ ï쳌¯ ï쳌® ï쳌¡ ï쳌­ ï쳌¡ ) pub - need to develop a national ï쳌¡ ï쳌¢ ï쳌³ policy . However , no participa - lished the National Biodiversity Strategy that was approved tory process has been initiated yet . Guatemala is a signatory of by ï쳌£ ï쳌¯ ï쳌® ï쳌¡ ï쳌­ ï쳌¡ â?? s Ministerial Council . Subsequently , in mid - ï?? ï?? ï?? ï?? the Central American draft protocol on â?? Access to genetic and the National Biodiversity Action Plan was initiated . It should biochemical resources , and their associated knowledge â?쳌 but it be noted that the strategy emphasizes the need to develop has not been ratified yet by this nation . ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : D ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¯ ï쳌¦ P ï쳌¯ ï쳌¬ ï쳌© ï쳌£ ï쳌© ï쳌¥ ï쳌³ ï쳌© ï쳌® P ï쳌¬ ï쳌¡ ï쳌£ ï쳌¥ ï쳌¡ ï쳌® ï쳌¤ ï쳌© ï쳌® P ï쳌² ï쳌¯ ï쳌§ ï쳌² ï쳌¥ ï쳌³ ï쳌³ Table ï?? . Continued ï?? ï?? . Honduras in this effort . However , under the Micronesiaâ??s Immigration The country is currently working on a national law to regulate law , Title ï?? ï?? of the Micronesian Code , researchers entering access and benefit - sharing issues . In ï?? ï?? ï?? ï?? , the National the country are required to declare the purpose of their visit . Strategy on Biodiversity was adopted and one of its strategic The Department of Immigration then refers the request to the themes was the ï쳌¡ ï쳌¢ ï쳌³ issue . Division of Archives and Preservation . If acceptable to that Division , the Department of Immigration issues an entry per - ï?? ï?? . Indonesia mit under the category â?? researcherâ??s permit â?쳌 to the entrant . Indonesia is currently working on a law that is likely to be called Act on Genetic Resource Management . This act will ï?? ï?? . New Zealand include a government regulation on ï쳌¡ ï쳌¢ ï쳌³ issues . The govern - The ï?? ï?? ï?? ï?? New Zealand Biodiversity Strategy addresses ï쳌¡ ï쳌¢ ï쳌³ ment is also conducting an assessment of existing legal instru - goals and includes the following desired outcome for ï?? ï?? ï?? ï?? : ments that regulate ï쳌¡ ï쳌¢ ï쳌³ issues . Local officials estimate that ï쳌¡ ï쳌¢ ï쳌³ â?? There is an integrated policy for the management of all legislation will be concluded in ï?? ï?? ï?? ï?? or ï?? ï?? ï?? ï?? . genetic material in New Zealand and for bioprospecting activi - ï?? ï?? . Japan ties , in accord with international commitments . There is appro - The Japanese government initiated a survey to collect policies priate domestic and international access to indigenous genetic on ï쳌¡ ï쳌¢ ï쳌³ . Also , several ministries are involved in the discussion material , taking into account New Zealandâ??s sovereignty and about ï쳌¡ ï쳌¢ ï쳌³ issues ; currently , discussion is at individual ministry rights to the benefits from its genetic material , as well as rights levels . The government has also been conducting studies on and obligations under the Treaty of Waitangi . â?쳌 In November global issues and trends on ï쳌¡ ï쳌¢ ï쳌³ policies through research ï?? ï?? ï?? ï?? , the Ministry of Economic Development published a contracts or financial assistance with think tanks . For example , discussion paper on bioprospecting . The paper invited the pub - the Japan Bioindustry Association ( ï쳌ª ï쳌¢ ï쳌© ) has been actively lic to submit comments by the end of February ï?? ï?? ï?? ï?? . In May participating in the meetings of the Conference of the Parties ï?? ï?? ï?? ï?? the Ministry posted a summary of the submissions on its to the ï쳌£ ï쳌¢ ï쳌¤ . ï쳌ª ï쳌¢ ï쳌© has also conducted studies and seminars to help website ( http : / / www.med.govt.nz / ers / nat - res / bioprospecting / implement the ï쳌£ ï쳌¢ ï쳌¤ in Japan , and in ï?? ï?? ï?? ï?? this organization index.html ) . Further consultation will follow with stakeholders published a policy statement that provided general and volun - such as the Maori people to examine key bioprospecting issues tary prior informed consent and benefit sharing guidelines for and a future national policy on ï쳌¡ ï쳌¢ ï쳌³ or bioprospecting will be its members . drafted taking into account this consultation process . However , future efforts to develop such a policy can be complicated by a ï?? ï?? . Malaysia claim by a number of tribes ( Iwi ) of the Maori people to a tri - The federal government is working on a national ï쳌¡ ï쳌¢ ï쳌³ bill bunal . According to this claim the Maori have exclusive own - that is likely to be adopted in ï?? ï?? ï?? ï?? . However , states such as ership rights over both traditional knowledge and indigenous Sabah and Sarawak already have the ï?? ï?? ï?? ï?? Sabah Biodiversity genetic resources under the Waitangi Treaty of ï?? ï?? ï?? ï?? between Enactment , the ï?? ï?? ï?? ï?? Sarawak Biodiversity Center Ordinance the chiefs of most New Zealand Iwi at the time and the British and the ï?? ï?? ï?? ï?? Sarawak Biodiversity Regulations . The relation - Government ( the Crown ) . This claim was lodged in ï?? ï?? ï?? ï?? , and ship between these policies that regulate ï쳌¡ ï쳌¢ ï쳌³ issues and the it does not appear that it will be concluded in the near future . new federal bill is uncertain . ï?? ï?? . Nicaragua ï?? ï?? . Marshall Islands The government developed a proposal for a law of biodiver - In ï?? ï?? ï?? ï?? , the National Biodiversity Strategy and Action Plan sity that addresses ï쳌¡ ï쳌¢ ï쳌³ issues . The proposal should be sent acknowledged the importance of regulating access to the to Congress in ï?? ï?? ï?? ï?? . Nicaraguaâ??s draft law of biodiversity countryâ??s genetic resources and ensuring that the benefits responds to the mandate ( Article ï?? ï?? ) of the ï?? ï?? ï?? ï?? General Law derived from the use of these resources are shared equitably . of the Environment and Natural Resources No . ï?? ï?? ï?? . Furthermore , the strategy calls for the development of ï쳌© ï쳌° ï쳌² legislation that protects the rights of indigenous owners of ï?? ï?? . Niue genetic resources and traditional knowledge and facilitates The protection of traditional knowledge and ï쳌¡ ï쳌¢ ï쳌³ have been access to and benefit sharing of these resources and knowledge identified as priority issues in the National Biodiversity under prior informed consent obligations . Plans to develop this Strategy and Action Plan . Therefore , funds were used to con - legislation are in progress . duct a consultancy to assess capacity needs in Niue related to this kind of work . Niue has experienced some access situations ï?? ï?? . Micronesia in the past year that suggest the urgent need for ï쳌¡ ï쳌¢ ï쳌³ legisla - Micronesia finished its National Biodiversity Strategy and tion . In the absence of this legislation , access applications have Action Plan in March ï?? ï?? ï?? ï?? . It is expected that the develop - been handled on a contractual basis . Village stakeholders are ment of ï쳌¡ ï쳌¢ ï쳌³ legislation will follow from the needs identi - particularly interested about strategies to protect traditional fied through this collaborative process between the National knowledge . An Environment Bill was approved in ï?? ï?? ï?? ï?? and Government and the four states . The two national govern - this will facilitate the insertion of ï쳌¡ ï쳌¢ ï쳌³ regulations and other ment departments that would be most involved in the pro - regulations that protect traditional knowledge . ï쳌¡ ï쳌¢ ï쳌³ regulations cess of developing access legislation are the Department of may be modeled after the South Pacific Regional Environment Justice and the Department of Economic Affairs , Sustainable Program ( ï쳌³ ï쳌° ï쳌² ï쳌¥ ï쳌° ) framework legislation on access and benefit Development Unit , National Biodiversity Strategy and Action sharing . Plan . Regional ï쳌¡ ï쳌¢ ï쳌³ model guidelines and legislation have been ï?? ï?? . Panama developed with the assistance of a number of multilateral bod - Panama is currently developing and modifying existing laws ies ( Secretariat of the Pacific Community , ï쳌· ï쳌· ï쳌¦ - South Pacific and policies to facilitate ï쳌¡ ï쳌¢ ï쳌³ goals . For example , draft Law Program , and the Foundation for International Environmental Law and Development ( ï쳌¦ ï쳌© ï쳌¥ ï쳌¬ ï쳌¤ ) among them ) that will assist No . ï?? ï?? , includes ï쳌¡ ï쳌¢ ï쳌³ , intellectual property , and marketing pro - ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ Table ï?? . Continued visions for products used in traditional indigenous medicine . Development Board , and National Science and Technology Also , Panama is working on an ï쳌¡ ï쳌¢ ï쳌³ and indigenous knowledge Board . The country does not have indigenous peoples engaged policy that is likely to provide a course of action about how to in traditional practices , therefore issues such as the protection implement existing and future ï쳌¡ ï쳌¢ ï쳌³ policies . The ï?? ï?? ï?? ï?? General of traditional knowledge are not being discussed by poli - Law of the Environment No . ï?? ï?? ( ï쳌§ ï쳌¬ ï쳌¥ ) designates the National cymakers . Singapore has also been actively involved in the Authority for the Environment ( ï쳌¡ ï쳌® ï쳌¡ ï쳌­ ) as the competent development of the ï쳌¡ ï쳌³ ï쳌¥ ï쳌¡ ï쳌® framework agreement on access to authority for the regulation , management , and control of the biological and genetic resources . access to and use of biogenetic resources . ï쳌¡ ï쳌® ï쳌¡ ï쳌­ shall also ï?? ï?? . Solomon Islands develop the legal instruments and economic mechanisms to In the last few years , this country has experienced a period of this purpose . ï쳌§ ï쳌¬ ï쳌¥ clarifies that the holders of rights granted for social and economic crisis on the island of Guadalcanal . The the use of natural resources do not hold rights for the use of shortage of economic resources caused by this situation and a genetic resources contained in them . weak governmental structure has delayed efforts to develop ac - ï?? ï?? . Papua New Guinea cess and benefit - sharing policies . However , they are beginning The Department of Environment and Conservation is working to examine ï쳌¡ ï쳌¢ ï쳌³ issues with the assistance of ï쳌³ ï쳌° ï쳌² ï쳌¥ ï쳌° and other closely with lawyers from the Department of Justice and the organizations such as ï쳌· ï쳌· ï쳌¦ South Pacific Program that orga - Attorney General to develop a framework on ï쳌¡ ï쳌¢ ï쳌³ . nized a workshop in May ï?? ï?? ï?? ï?? . In the meantime , bioprospec - ï?? ï?? . Republic of Korea tors may apply for a research permit under the Research Act to Comprehensive ï쳌¡ ï쳌¢ ï쳌³ provisions are proposed for addition to the Ministry of Education and Training . The Ministry liaises the ï?? ï?? ï?? ï?? National Environment Conservation Act No . ï?? ï?? ï?? ï?? with provinces and communities where research activity is to by amendment . The ï?? ï?? ï?? ï?? amendment ( Law No . ï?? ï?? ï?? ï?? ) of the occur and a research committee decides whether to approve act included one provision that facilitated access but it did not or reject the application . This decision takes into account the regulate benefit - sharing issues . Article ï?? ï?? . ï?? of the act applied views of provincial authorities and communities . only to foreigners and it regulated the use of domestic biologi - ï?? ï?? . Vanuatu cal resources ( excluding selected wild animals and plans ) After a national consultation process , the country is ana - for commercial , medical or scientific use . This provision , lyzing ï쳌¡ ï쳌¢ ï쳌³ policies that might be included in a draft of its however , was removed from the act by Law No . ï?? ï?? ï?? ï?? of ï?? Environment Act . Vanuatu , however , has a Cultural Research February ï?? ï?? ï?? ï?? . Policy that regulates consultation with local communities , ï?? ï?? . Russian Federation chiefâ??s councils , and womenâ??s groups . An important problem for the country is the absence of ï?? ï?? . Vietnam coordinated measures towards conservation and sustainable In ï?? ï?? ï?? ï?? Vietnam developed a National Action Plan on utilization of biodiversity . In ï?? ï?? ï?? ï?? , Russia started imple - Biological Diversity that addresses ï쳌¡ ï쳌¢ ï쳌³ issues . In the last few menting the project of the Global Ecological Foundation years the government has been actively collecting examples Biodiversity Conservation . This project included three compo - of ï쳌¡ ï쳌¢ ï쳌³ laws and policies and it is planning to start working on nents : Strategy of Biodiversity Conservation ( ï?? ï?? ï?? ï?? ) , Protected national ï쳌¡ ï쳌¢ ï쳌³ legislation in ï?? ï?? ï?? ï?? or ï?? ï?? ï?? ï?? . Natural Regions ( ï?? ï?? ï?? ï?? ) , and Baikal Region ( ï?? ï?? ï?? ï?? ) . The Supervisory Committee and Management Group , nominated C . Countries not involved in any process leading to the for the project , have already begun preparing The National development of ABS laws and policies and Regional Strategy , and establishing ecological networks of ï?? . Kiribati protected areas ( ï?? ï?? reserves and national parks ) . In mid - ï?? ï?? ï?? ï?? , It is a high priority but the country lacks the funding needed to the National Report of the Russian Federation on ï쳌¡ ï쳌¢ ï쳌³ was develop ï쳌¡ ï쳌¢ ï쳌³ policies . The National Biodiversity Strategy and prepared for the Conference of the Parties of the ï쳌£ ï쳌¢ ï쳌¤ . The Action Plan , however , may create momentum to begin the ï쳌¡ ï쳌¢ ï쳌³ report states that prior to the development of an ï쳌¡ ï쳌¢ ï쳌³ policy it development process . The plan was completed in February is necessary to establish a national coordination center for the ï?? ï?? ï?? ï?? but it has not been tabled yet by the Cabinet for approval problems related with access to genetic resources . Since ï?? ï?? ï?? ï?? , and endorsement . the Department of Life and Earth Sciences of the Ministry of Industry , Science , and Technologies of the Russian Federation ï?? . Laos has been analyzing gaps , contradictions , and needs of existing Lack of financial support and technical expertise has prevented national laws and policies that apply to ï쳌¡ ï쳌¢ ï쳌³ goals . Some of the this country from developing an ï쳌¡ ï쳌¢ ï쳌³ policy . challenges faced by policymakers include identifying land and ï?? . Nauru genetic resources ownership rights and increasing awareness ï쳌¡ ï쳌¢ ï쳌³ is not a top priority , and there are budgetary constraints . about ï쳌¡ ï쳌¢ ï쳌³ issues among local administrators , members of ï?? . Palau Parliament , policymakers , and the public in general . Palau should start working on an ï쳌¡ ï쳌¢ ï쳌³ policy in ï?? ï?? ï?? ï?? â?? ï?? ï?? ï?? ï?? , ï?? ï?? . Singapore depending on funding and capacity availability . However , this The country is currently formulating policy and guidelines that country is currently working on a national biodiversity strategy will regulate ï쳌¡ ï쳌¢ ï쳌³ issues . An ad hoc inter - agency committee is and action plan . working on a strategy document on access to genetic resourc - ï?? . Tonga es . Member agencies of the committee include : the Intellectual This subject has not been raised with the government by the Property Office of Singapore ( Ministry of Law ) , Attorney - relevant government body , the Ministry of Labor , Commerce , Generalâ??s Chambers , Ministry of National Development , and Industries . Tonga , however , is working on a national biodi - Agri - Food and Veterinary Authority of Singapore , Ministry of Trade and Industry , Economic Development Board , Trade versity strategy and action plan . ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : D ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¯ ï쳌¦ P ï쳌¯ ï쳌¬ ï쳌© ï쳌£ ï쳌© ï쳌¥ ï쳌³ ï쳌© ï쳌® P ï쳌¬ ï쳌¡ ï쳌£ ï쳌¥ ï쳌¡ ï쳌® ï쳌¤ ï쳌© ï쳌® P ï쳌² ï쳌¯ ï쳌§ ï쳌² ï쳌¥ ï쳌³ ï쳌³ Table ï?? . Continued ï?? . Tuvalu Tuvalu ratified the ï쳌£ ï쳌¢ ï쳌¤ in December ï?? ï?? ï?? ï?? and developing ï쳌¡ ï쳌¢ ï쳌³ regulations is not a top priority . ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ Table ï?? . Status of intellectual property rights in Pacific Rim countries signing the ï쳌£ ï쳌¢ ï쳌¤ health purposes ( Article ï?? ï?? ) . There is a criterion that is based A . Countries with ABS laws and policies on the thesis that reforms to the Patent Law of ï?? ï?? ï?? ï?? tacitly ï?? . Colombia derogated the exclusions of the Law of Biodiversity since they Colombia is a member of the World Intellectual Property were promulgated later on ; it excludes some , but not all , of the Organization ( ï쳌· ï쳌© ï쳌° ï쳌¯ ) and World Trade Organization ( ï쳌· ï쳌´ ï쳌¯ ) . It aspects provided in Article ï?? ï?? from the patent process . is also a signatory to the Agreement on Trade - Related Aspects ï?? . Ecuador of Intellectual Property Rights ( ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ ) . All ï쳌· ï쳌´ ï쳌¯ members Ecuador is a ï쳌· ï쳌© ï쳌° ï쳌¯ and ï쳌· ï쳌´ ï쳌¯ member , a signatory to ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ , and are de facto Parties to all ï쳌· ï쳌´ ï쳌¯ agreements . Colombia is also a member of the Andean Community and as a member of a member of Andean Community . See Colombia for informa - this organization , it is protected by the Common Regime on tion about ï쳌© ï쳌° ï쳌² legislation that covers all Andean Community Industrial Property , Decision ï?? ï?? ï?? of ï?? ï?? ï?? ï?? . With this Decision , countries . the Andean Community countries complied with ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ . ï?? . Mexico Decision ï?? ï?? ï?? and Decision ï?? ï?? ï?? ( i.e . , the Andean ï쳌¡ ï쳌¢ ï쳌³ law ) have Mexico is a ï쳌· ï쳌© ï쳌° ï쳌¯ and ï쳌· ï쳌´ ï쳌¯ member and therefore a signa - a strong connection . Decision ï?? ï?? ï?? requires patent applicants tory to ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ . The ï?? ï?? ï?? ï?? Industrial Property Act ( amended in to present a copy of the access contract when the products ï?? ï?? ï?? ï?? and ï?? ï?? ï?? ï?? ) provides patent protection for products and or procedures of the patent requested have been obtained or processes that comply with the patentability test of novelty , developed from genetic resources or their derivatives of which inventiveness , and industrial application . It excludes protec - any of the member countries are countries of origin . If ap - tion for biological and genetic material as found in nature . The plicable , a copy of the authorization for the use of traditional ï?? ï?? ï?? ï?? Federal Plan Variety Act protects varieties that are new , knowledge from indigenous , Afro - American , and local com - stable , distinct , and homogeneous . munities , when the products for which the patent is requested ï?? . Philippines have been obtained or developed from such knowledge of The Philippines is a ï쳌· ï쳌© ï쳌° ï쳌¯ and ï쳌· ï쳌´ ï쳌¯ member and therefore which any of the member countries is a country of origin . a signatory to ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ . This country is also member of the Colombia does not have in place a comprehensive system to ï?? ï?? ï?? ï?? ï쳌¡ ï쳌³ ï쳌¥ ï쳌¡ ï쳌® Framework Agreement on Intellectual Property protect traditional knowledge . Decision ï?? ï?? ï?? establishes that a Cooperation . The ï?? ï?? ï?? ï?? Intellectual Property Code was enacted norm to protect these rights has to be proposed at the Andean in compliance with the minimum standards set under ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ . Community level , but this has not occurred . Colombia is also As of ï?? ï?? ï?? ï?? , more than ï?? ï?? ï?? microorganisms have been granted covered by the ï?? ï?? ï?? ï?? Decision ï?? ï?? ï?? of Andean Community that patent protection in the Philippines . The law excludes from protects plant breeders â?? rights . patent protection plant varieties and animal breeds . It also does ï?? . Costa Rica not give protection to traditional knowledge , but allows for Costa Rica is a ï쳌· ï쳌© ï쳌° ï쳌¯ and ï쳌· ï쳌´ ï쳌¯ member and therefore a Party the creation of a sui generis protection system for community to ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ . Intellectual property right requirements and condi - intellectual property rights . In ï?? ï?? ï?? ï?? , Congress passed a plant tions are clearly stated in the Law of Biodiversity . The Law variety protection bill ( Republic Act No . ï?? ï?? ï?? ï?? ) that provides established diverse exclusions but the compatibility of some sui generis protection over plant varieties and Farmerâ??s Rights . of these exclusions with ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ is debatable . Costa Rica has Patent protection over life forms including microorganisms comprehensive legislation related to ï쳌© ï쳌° ï쳌² s . The ï?? ï?? ï?? ï?? Patent , remains a controversial issue in the Philippines . It is argued Drawings and Utility Models Law No . ï?? ï?? ï?? ï?? was reformed that life forms are not eligible for patents because nothing new by Law No . ï?? ï?? ï?? ï?? of ï?? ï?? ï?? ï?? to make it compatible with ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ . is created and the process merely involves reorganizing some - The new law has no exclusions for microorganisms , biologi - thing that already exists . In ï?? ï?? ï?? ï?? , Republic Act No . ï?? ï?? ï?? ï?? , also cal processes , genes , and genetic sequences as long as the known as the Traditional Alternative Medicine Act was passed patentability requirements are met . A plant breeders â?? rights in order to protect traditional knowledge related to tradi - draft law is yet to be approved . A proposal for a sui generis tional medicine . This law is not operational yet . However , the system of intellectual community rights is being developed Philippines has yet to pass a sui generis intellectual property through a consultation process that begun recently . The rights system that will cover traditional knowledge associated National Commission for the Management of Biodiversity with biological and genetic resources . must propose policies on access to genetic and biochemical ï?? . Peru resources of ex situ and in situ biodiversity . It will also act as Peru is a ï쳌· ï쳌© ï쳌° ï쳌¯ and ï쳌· ï쳌´ ï쳌¯ member , a signatory to ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ , and as an obligatory consultant in procedures related to the protec - member of the Andean Community , it is covered by regional tion of intellectual property rights on biodiversity . The General ï쳌© ï쳌° ï쳌² legislation . See Colombia for details about these laws . In Access Procedure ( bylaw of the Law of Biodiversity ) states addition , the ï?? ï?? ï?? ï?? Peruvian Law ï?? ï?? ï?? ï?? ï?? provides a sui generis as one of the criteria : Intellectual property rights not affecting system for the protection indigenous peoples â?? collective key agricultural products and processes for the nourishment knowledge about properties , uses , and characteristics of bio - and health of the countryâ??s inhabitants . This criterion also logical diversity . The law creates three registers for the protec - includes protection for the resources of local communities and tion of collective knowledge as follows : a ) national register for indigenous populations . The Law of Biodiversity excludes collective knowledge that is in the public domain ; b ) national ï쳌¤ ï쳌® ï쳌¡ sequences from patent processes ; plants and animals ; register for confidential collective knowledge ; and c ) local unmodified microorganisms ; essential biological processes for registers for either kind of collective knowledge . plant and animal production ; the processes or natural cycles ; ï?? . Samoa inventions essentially derived from the knowledge involved or Samoa is a ï쳌· ï쳌© ï쳌° ï쳌¯ member and a ï쳌· ï쳌´ ï쳌¯ observer . Samoa has a biological traditional practices or in public domain ; the inven - ï?? ï?? ï?? ï?? Patents Act that will be strengthened in order to comply tions that are produced monopolistically that may affect the processes or agricultural basic products used for feeding and with the requirements of ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ . ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : D ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¯ ï쳌¦ P ï쳌¯ ï쳌¬ ï쳌© ï쳌£ ï쳌© ï쳌¥ ï쳌³ ï쳌© ï쳌® P ï쳌¬ ï쳌¡ ï쳌£ ï쳌¥ ï쳌¡ ï쳌® ï쳌¤ ï쳌© ï쳌® P ï쳌² ï쳌¯ ï쳌§ ï쳌² ï쳌¥ ï쳌³ ï쳌³ Table ï?? . Continued ï?? . Thailand to ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ . The ï?? ï?? ï?? ï?? Patent Act ( amended in ï?? ï?? ï?? ï?? and ï?? ï?? ï?? ï?? ) is ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ compatible . China also has the ï?? ï?? ï?? ï?? Regulation for Thailand is a ï쳌· ï쳌´ ï쳌¯ and ï쳌· ï쳌© ï쳌° ï쳌¯ member . The countryâ??s ï?? ï?? ï?? ï?? Protection of New Plant Varieties . The patent system does not patent law ( amended in ï?? ï?? ï?? ï?? ) complies with ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ . The ï?? ï?? ï?? ï?? protect genes yet . However , Chinaâ??s patent authority is consid - plant variety protection law protects is considered a sui generis ering incorporating genes under patent protection in the future . protection system . It protects new , traditional , community and wild varieties . Thailand is also member of the ï?? ï?? ï?? ï?? ï쳌¡ ï쳌³ ï쳌¥ ï쳌¡ ï쳌® ï?? . Cook Islands Framework Agreement on Intellectual Property Cooperation . This country is neither a ï쳌· ï쳌© ï쳌° ï쳌¯ nor a ï쳌· ï쳌´ ï쳌¯ member . It does not have any intellectual property right system . ï?? . United States of America ( ï쳌µ ï쳌³ ï쳌¡ ) The ï쳌µ ï쳌³ ï쳌¡ is a ï쳌· ï쳌© ï쳌° ï쳌¯ and ï쳌· ï쳌´ ï쳌¯ member and therefore a signatory ï?? . El Salvador to ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ . Unlike the other countries examined in this report El Salvador is a ï쳌· ï쳌© ï쳌° ï쳌¯ and ï쳌· ï쳌´ ï쳌¯ member and therefore a the ï쳌µ ï쳌³ ï쳌¡ is not a ï쳌£ ï쳌¢ ï쳌¤ Party . The Plan Patent Act of ï?? ï?? ï?? ï?? gave signatory to ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ . The ï?? ï?? ï?? ï?? Law on the Promotion and protection to clonally propagated varieties of plants such as Protection of Intellectual Property and its ï?? ï?? ï?? ï?? regulation is fruit trees and tubers . In ï?? ï?? ï?? ï?? , the Plan Variety Protection Act ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ compatible . The country is currently working on a plant granted protection to new , uniform and distinct plant varieties . variety protection law , but it has not addressed the issue of a In ï?? ï?? ï?? ï?? , the Supreme Court opened the door for patents to be sui generis system to protect traditional knowledge . applied to plants , animals , microorganisms , genes , and ï쳌¤ ï쳌® ï쳌¡ ï?? . Fiji sequences . In late ï?? ï?? ï?? ï?? , the US Supreme Court also ruled that Fiji is a ï쳌· ï쳌© ï쳌° ï쳌¯ and ï쳌· ï쳌´ ï쳌¯ member and therefore a signatory to plant varieties are eligible for protection by utility patents , ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ . It is currently reviewing the Fiji Patent Act of ï?? ï?? ï?? ï?? . as well as under the Plant Patent Act of ï?? ï?? ï?? ï?? and the Plant There is no plant variety protection legislation . Variety Protection Act of ï?? ï?? ï?? ï?? . ï?? . Guatemala Guatemala is a ï쳌· ï쳌© ï쳌° ï쳌¯ and ï쳌· ï쳌´ ï쳌¯ member and therefore a signa - B . Countries working towards the development of ABS tory to ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ member . The ï?? ï?? ï?? ï?? Industrial Property Law laws and policies provides patent protection . ï?? . Australia ï?? ï?? . Honduras Australia is a ï쳌· ï쳌© ï쳌° ï쳌¯ and ï쳌· ï쳌´ ï쳌¯ member and therefore a signatory Honduras is a ï쳌· ï쳌© ï쳌° ï쳌¯ and ï쳌· ï쳌´ ï쳌¯ member and therefore a signa - to ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ . The ï?? ï?? ï?? ï?? Patent Act ( amended in ï?? ï?? ï?? ï?? and ï?? ï?? ï?? ï?? ) tory to ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ . The ï?? ï?? ï?? ï?? Law on Industrial Property provides allows for the patenting of plants , microorganisms , and related patent protection . The country is also about to approve a draft biological materials , provided that these meet the standards of law for the protection of new varieties of plants . proof for patentability . The ï?? ï?? ï?? ï?? Plant Breeders â?? Rights Act ï?? ï?? . Indonesia ( amended in ï?? ï?? ï?? ï?? ) provides plant variety protection . Indonesia is a ï쳌· ï쳌© ï쳌° ï쳌¯ and ï쳌· ï쳌´ ï쳌¯ member and therefore a signa - ï?? . Cambodia tory to ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ . Amendments to the ï?? ï?? ï?? ï?? Patent and Trademark Cambodia is a ï쳌· ï쳌© ï쳌° ï쳌¯ member and it is in the process of Acts as well as membership to several international treaties becoming a ï쳌· ï쳌´ ï쳌¯ member . The ï?? ï?? ï?? ï?? Patents , Utility Model were conducted between ï?? ï?? ï?? ï?? and ï?? ï?? ï?? ï?? . The Patent Law is Certificates and Industrial Designs Act provides patent protec - ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ compatible . Nonbiological genetic engineering technolo - tion . In addition , Cambodia is completing a Plant Variety gies are also patentable . It excludes all living organisms and Protection Act . biological processes used for the production of plants and ani - ï?? . Canada mals , except microorganisms and plant varieties . Indonesiaâ??s Canada is ï쳌· ï쳌© ï쳌° ï쳌¯ and ï쳌· ï쳌´ ï쳌¯ member and therefore a signatory ï?? ï?? ï?? ï?? Law on Plant Variety Protection protects new varieties as to ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ . The ï?? ï?? ï?? ï?? Patent Act ( amended in ï?? ï?? ï?? ï?? , ï?? ï?? ï?? ï?? , ï?? ï?? ï?? ï?? , well as local or indigenous varieties . This country is a member ï?? ï?? ï?? ï?? , ï?? ï?? ï?? ï?? , ï?? ï?? ï?? ï?? , and ï?? ï?? ï?? ï?? ) is compatible with ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ . No of the ï?? ï?? ï?? ï?? ï쳌¡ ï쳌³ ï쳌¥ ï쳌¡ ï쳌® Framework Agreement on Intellectual patents are granted on higher life forms . In December ï?? ï?? ï?? ï?? Property Cooperation . the Supreme Court of Canada ruled that the Harvard Mouse ï?? ï?? . Japan cannot be patented . The ï?? ï?? ï?? ï?? Plant Breeders â?? Rights Act Japan has the longest tradition of industrial property rights in ( amended in ï?? ï?? ï?? ï?? and ï?? ï?? ï?? ï?? ) protects plant varieties . Asia . This country is a ï쳌· ï쳌© ï쳌° ï쳌¯ and ï쳌· ï쳌´ ï쳌¯ member and therefore a ï?? . Chile signatory to ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ . The Patent Law was amended in ï?? ï?? ï?? ï?? and Chile is a ï쳌· ï쳌© ï쳌° ï쳌¯ and ï쳌· ï쳌´ ï쳌¯ member . The ï?? ï?? ï?? ï?? Industrial ï?? ï?? ï?? ï?? . The ï?? ï?? ï?? ï?? Seeds and Seedlings Law ( amended in ï?? ï?? ï?? ï?? ) Property Act provides patent protection . The ï?? ï?? ï?? ï?? Law provides protection for new plant varieties . Nº ï?? ï?? . ï?? ï?? ï?? protects new plant varieties . The current legislation ï?? ï?? . Malaysia only excludes expressly the patenting of plant and animal vari - Malaysia is both a ï쳌· ï쳌© ï쳌° ï쳌¯ and ï쳌· ï쳌´ ï쳌¯ member and therefore a sig - eties . Currently , the Chilean intellectual property legislation is natory to ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ . Intellectual property rights ( nonpatentability , being modified in order to make it compatible with require - limitations , certificate of origin and î?© î?? î?? , compulsory licenses ) . ments of ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ . Regarding the modifications proposed for the The ï?? ï?? ï?? ï?? Patent Act ( amended in ï?? ï?? ï?? ï?? , ï?? ï?? ï?? ï?? , and ï?? ï?? ï?? ï?? ) is patents system , the main changes are related to the period of ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ compatible . The draft Access to Genetic Resources Bill protection of the rights conferred by the patent ( it increases includes a nonpatentability provision which means that no from ï?? ï?? to ï?? ï?? years ) and procedural aspects for the concession patents shall be recognized with respect to : ï?? ) plants , animals , of this right . Specifically in relation to the patentability of dif - and naturally occurring microorganisms , including the parts ferent forms of life the Bill excludes plants and animals from thereof and ï?? ) essentially biological processes and naturally patent protection ( with the exception of microorganisms ) . occurring microbiological processes . To satisfy additional ï?? . China ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ requirements there is a draft Protection of New Plant China is a ï쳌· ï쳌© ï쳌° ï쳌¯ and ï쳌· ï쳌´ ï쳌¯ member and therefore a signatory Varieties Bill that is essentially a sui generis system for the ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ Table ï?? . Continued protection of plant genetic resources . Malaysia is also a mem - to comply with ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ . The ï?? ï?? ï?? ï?? Law on the Protection of ber of the ï?? ï?? ï?? ï?? ï쳌¡ ï쳌³ ï쳌¥ ï쳌¡ ï쳌® Framework Agreement on Intellectual Selection Achievements provide plant variety protection . Property Cooperation . ï?? ï?? . Singapore ï?? ï?? . Marshall Islands Singapore is a ï쳌· ï쳌© ï쳌° ï쳌¯ and ï쳌· ï쳌´ ï쳌¯ member and therefore a signa - At present there is no ï쳌© ï쳌° ï쳌² legislation in the Marshall Islands . tory to ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ . The Patent Act ( amended in ï?? ï?? ï?? ï?? , ï?? ï?? ï?? ï?? , and This country is neither a ï쳌· ï쳌© ï쳌° ï쳌¯ nor a ï쳌· ï쳌´ ï쳌¯ member . There are ï?? ï?? ï?? ï?? ) fully complies with ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ . The country also has a plant plans to develop legislation that protects the rights of indig - variety protection law and it is a member of the ï?? ï?? ï?? ï?? ï쳌¡ ï쳌³ ï쳌¥ ï쳌¡ ï쳌® enous owners of genetic resources and traditional knowledge , Framework Agreement on Intellectual Property Cooperation . and to provide access to that knowledge and resources with the ï?? ï?? . Solomon Islands prior informed consent of the owners , provided that these own - This country does not have intellectual property right legisla - ers have an equitable share of the benefits from the use of that tion . It is neither a ï쳌· ï쳌© ï쳌° ï쳌¯ nor a ï쳌· ï쳌´ ï쳌¯ member . knowledge and genetic materials . ï?? ï?? . Vanuatu ï?? ï?? . Micronesia This country is neither a ï쳌· ï쳌© ï쳌° ï쳌¯ nor a ï쳌· ï쳌´ ï쳌¯ member . Vanuatu is This country is neither a ï쳌· ï쳌© ï쳌° ï쳌¯ nor a ï쳌· ï쳌´ ï쳌¯ member and does not promoting a Traditional Property Rights Policy to protect tradi - have either patent legislation or sui generis systems in place tional knowledge . The policy would protect information about that would protect inventions derived from genetic resources names , designs or forms , oral tradition , practices and skills . and traditional knowledge . ï?? ï?? . Vietnam ï?? ï?? . New Zealand Vietnam is a ï쳌· ï쳌© ï쳌° ï쳌¯ member and a ï쳌· ï쳌´ ï쳌¯ observer . The ï?? ï?? ï?? ï?? New Zealand is a ï쳌· ï쳌© ï쳌° ï쳌¯ and ï쳌· ï쳌´ ï쳌¯ member and therefore a signa - Civil Code includes a chapter on industrial property . The Civil tory to ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ . The ï?? ï?? ï?? ï?? Patent Act ( amended in ï?? ï?? ï?? ï?? ) provides Code covers the basics of intellectual property , and has been patent protection for genetic resources . The ï?? ï?? ï?? ï?? Plant Variety supplemented by decrees on patents , trademarks , designs , util - Rights Act ( amended in ï?? ï?? ï?? ï?? ) protects new plant varieties . ity models , and appellations of origin ( ï?? ï?? ï?? ï?? ) , and copyright ï?? ï?? . Nicaragua ( ï?? ï?? ï?? ï?? ) . The Patent Act includes broad compulsory licensing Nicaragua is a ï쳌· ï쳌© ï쳌° ï쳌¯ and ï쳌· ï쳌´ ï쳌¯ member and therefore a signa - provisions under public health or national security condi - tory to ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ . The ï?? ï?? ï?? ï?? Plant Variety Protection Law and its tions . It is uncertain whether genetically modified organisms ï?? ï?? ï?? ï?? regulation provide protection for new varieties of plants . and particularly microorganisms can be protected . Vietnam is The ï?? ï?? ï?? ï?? law on Patents , Utility Models , and Industrial also a member of the ï?? ï?? ï?? ï?? ï쳌¡ ï쳌³ ï쳌¥ ï쳌¡ ï쳌® Framework Agreement on Designs is compatible with ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ . The country is also develop - Intellectual Property Cooperation . ing a draft law for the protection of traditional knowledge . C . Countries not involved in any process leading to the ï?? ï?? . Niue development of ABS laws and policies Niue does not have legislation that protects intellectual property derived from biological resources . This country is ï?? . Kiribati neither a ï쳌· ï쳌© ï쳌° ï쳌¯ nor a ï쳌· ï쳌´ ï쳌¯ member . Kiribati does not have an intellectual property right system . This country is neither a ï쳌· ï쳌© ï쳌° ï쳌¯ nor a ï쳌· ï쳌´ ï쳌¯ member . ï?? ï?? . Panama Panama is a ï쳌· ï쳌© ï쳌° ï쳌¯ and ï쳌· ï쳌´ ï쳌¯ member and therefore a signatory ï?? . Laos to ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ . The ï?? ï?? ï?? ï?? Law on Industrial Property and its ï?? ï?? ï?? ï?? Laos is a ï쳌· ï쳌© ï쳌° ï쳌¯ member and a ï쳌· ï쳌´ ï쳌¯ observer . The ï?? ï?? ï?? ï?? Prime regulation provide patent protection . Decree No . ï?? ï?? of ï?? ï?? ï?? ï?? Minister Decree on Patents , Industrial Designs and Utility and Law No . ï?? ï?? of ï?? ï?? ï?? ï?? provide protection for new plant Models and its ï?? ï?? ï?? ï?? regulation provides for patent protec - varieties . The ï?? ï?? ï?? ï?? Special Regime on Intellectual Property tion . Laos is also a member of the ï?? ï?? ï?? ï?? ï쳌¡ ï쳌³ ï쳌¥ ï쳌¡ ï쳌® Framework over Collective Rights protects collective rights of indigenous Agreement on Intellectual Property Cooperation . peoples over models , drawings , designs , symbols , petrogliphs , ï?? . Nauru and other innovations . Nauru does not have an intellectual property right system . This country is neither a ï쳌· ï쳌© ï쳌° ï쳌¯ nor a ï쳌· ï쳌´ ï쳌¯ member . ï?? ï?? . Papua New Guinea Papua New Guinea is a ï쳌· ï쳌© ï쳌° ï쳌¯ and ï쳌· ï쳌´ ï쳌¯ member and therefore a ï?? . Palau signatory to ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ . The ï?? ï?? ï?? ï?? Patent and Industrial Act protects There are no statutory or regulatory intellectual property rights inventions derived from genetic resources . at this time . This country is neither a ï쳌· ï쳌© ï쳌° ï쳌¯ nor a ï쳌· ï쳌´ ï쳌¯ member . ï?? ï?? . Republic of Korea ï?? . Tonga The Republic of Korea is a ï쳌· ï쳌© ï쳌° ï쳌¯ and ï쳌· ï쳌´ ï쳌¯ member and there - Tonga is a ï쳌· ï쳌© ï쳌° ï쳌¯ member and a ï쳌· ï쳌´ ï쳌¯ observer . The ï?? ï?? ï?? ï?? fore a signatory to ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ . The ï?? ï?? ï?? ï?? Patent Law and the ï?? ï?? ï?? ï?? Industrial Property Act provides patent protection , but it needs Law on the Promotion of Inventions comply with ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ . The to be reformed in order to comply with ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ . The Bill on ï?? ï?? ï?? ï?? Seed Industry Law protects plant breeders â?? rights . Seeds and Seedlings protects new varieties of plants . ï?? . Tuvalu ï?? ï?? . Russian Federation Tuvalu does not have intellectual property rights legislation . The Russian Federation is a ï쳌· ï쳌© ï쳌° ï쳌¯ member and a ï쳌· ï쳌´ ï쳌¯ ob - server . The ï?? ï?? ï?? ï?? Patent Law needs to be reformed in order This country is neither a ï쳌· ï쳌© ï쳌° ï쳌¯ nor a ï쳌· ï쳌´ ï쳌¯ member . ï?? ï?? 2 Scenarios of Policymaking Process Santiago Carrizosa The ï?? ï?? ï?? ï?? Bonn Guidelines onAccess to Genetic Resources they encounter obstacles that prevent their effective and efficient implementation , affect the interests of local com - and Fair and Equitable Sharing of the Benefits arising out munities , and prevent the flow of genetic resources among of their Utilization ( hereafter Bonn Guidelines on access nations . This chapter is divided into two main parts : the and benefit sharing ( ï쳌¡ ï쳌¢ ï쳌³ ) ) adopted by the Sixth Conference first part describes the policymaking process and main of the Parties of the ï쳌£ ï쳌¢ ï쳌¤ , have provided guidance for the concerns experienced during the development of national countries embarked on the development of ï쳌¡ ï쳌¢ ï쳌³ frame - 1 ï쳌¡ ï쳌¢ ï쳌³ laws and polices inAustralia , Chile , China , Colombia , works . Several international bioprospecting projects have Cook Islands , Costa Rica , Ecuador , El Salvador , Honduras , directly and indirectly encouraged policymakers to develop Indonesia , Malaysia , Mexico , Nicaragua , Panama , Philip - national ï쳌¡ ï쳌¢ ï쳌³ policies . However , this has been a long and pines , Peru , Samoa , Thailand , andVanuatu ; and the second difficult process for many nations . Developing balanced part analyzes the policymaking process and identifies key ï쳌¡ ï쳌¢ ï쳌³ laws is a slow process in which multiple sectors of lessons and patterns derived from the case studies pre - society with different interests , views , and backgrounds sented in the first part of this chapter . must play a role . Even countries that enacted ï쳌¡ ï쳌¢ ï쳌³ laws and policies in the mid - ï?? ï?? s are still reforming such policies as Policymaking Process and Main Concerns : Case Studies count their existing policy frameworks . Australia The ï쳌¡ ï쳌¢ ï쳌³ development process continued in mid - ï?? ï?? ï?? ï?? Process with the announcement of an inquiry into access to bio - Development of ï쳌¡ ï쳌¢ ï쳌³ policies in the Commonwealth areas logical resources in Commonwealth areas . The inquiry , beganin ï?? ï?? ï?? ï?? whenaconsultativegroupofCommonwealth , initiated by the Minister for the Environment and Heritage , State , and Territory environment ministers produced a was the most significant event in the development process report on the implementation and implications of ratifica - of ï쳌¡ ï쳌¢ ï쳌³ regulations . Its main objective was to advise on a tion of the ï쳌£ ï쳌¢ ï쳌¤ . In ï?? ï?? ï?? ï?? , First Ministers established the scheme that could be implemented through regulations Commonwealth State Working Group ( ï쳌£ ï쳌³ ï쳌· ï쳌§ ) . The ï쳌£ ï쳌³ ï쳌· ï쳌§ under section ï?? ï?? ï?? of the Environment Protection and addressed the issue of establishing a nationally consistent Biodiversity Conservation Act of ï?? ï?? ï?? ï?? ( ï쳌¥ ï쳌° ï쳌¢ ï쳌£ ï쳌¡ ) to pro - system of access arrangements for the Commonwealth , vide for the control of access to biological resources in States , and Territories and concluded that a nationally Commonwealth areas . In January ï?? ï?? ï?? ï?? the inquiry was consistent system should focus on broad principles while advertised in national , state , and territory newspapers . allowing jurisdictions the freedom to apply those principles The inquiry received ï?? ï?? submissions and held two public in ways which meet their needs and which take into ac - hearings and consultations with the traditional owners ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ of the three national parks and their representatives ( see found in in situ conditions belong to the inventor . However , the inquiry stated that it is up to a Commonwealth agency Chapter ï?? ) . to allow access only if ownership of products derived from In September ï?? ï?? ï?? ï?? the Minister released the inquiry genetic resources is shared jointly with the inventor , the report for public comment and promoted another one - year Commonwealth agency , and a representative of indigenous period of consultations with Biotechnology Australia de - communities that may own the resource . Many ï쳌® ï쳌§ ï쳌¯ s and partments and other agencies . In September ï?? ï?? ï?? ï?? , the indigenous groups also rejected the idea of patenting life , Minister for the Environment and Heritage released the namely sequences of genes and the organisms that embody draft of the regulations for a period of public consulta - these genes . Australian patent law , however , allows this tion ending in October ï?? ï?? ï?? ï?? . The regulations reflect the practice . Indigenous groups also argued that their cultural scheme proposed by the inquiry and they are likely to be knowledge related to plants , animals , and the environment enacted in ï?? ï?? ï?? ï?? . was being used by scientists , medical researchers , nutri - Another significant result of the inquiry was the reacti - tionists , and pharmaceutical companies for commercial vation of the idea of a nationally consistent system as it was gain , often without their prior informed consent ( ï쳌° ï쳌© ï쳌£ ) and proposed by the ï쳌£ ï쳌³ ï쳌· ï쳌§ in ï?? ï?? ï?? ï?? . This system would prevent without any economic benefits flowing back to them . In the the risk of a â?? price war â?쳌 among Australian jurisdictions knowledge that these are significant and sensitive issues that could be caused by bioprospectors while shopping for indigenous people , the inquiry recommended further for the easiest and most accessible genetic resources . In research and consultations with stakeholders . October ï?? ï?? ï?? ï?? , Australiaâ??s Natural Resource Management Scientists were also concerned that the access scheme Ministerial Council released fourteen principles to promote and the model contract might not be sufficiently flexible the development or review of legislative , administrative , or and effective to allow the negotiation of benefits in com - policy frameworks for a nationally consistent approach in mercial and noncommercial access situations . In addition , each jurisdiction ( see Chapter ï?? ) . Therefore , in December the access process could inhibit noncommercial research ï?? ï?? ï?? ï?? the Government of Western Australia released a con - activities . In this regard the inquiry recommended that pro - sultation paper to promote the idea of a new act ( i.e . , A visions in the proposed model contract should anticipate Biodiversity Conservation Act for Western Australia ) . The that most contractual arrangements will be for commercial new act would include a licensing regime for terrestrial purposes but that in some cases , provisions should be flex - bioprospecting activities to ensure that benefits arising ible enough to address situations where access conditions from the exploitation of Western Australiaâ??s biological for noncommercial initiatives are negotiated . resources are shared with the Western Australian com - Exclusivity issues were also addressed during the con - munity , among other objectives.Australiaâ??s ï쳌¡ ï쳌¢ ï쳌³ policy will sultation process . In theory parties to a contract should be be compatible with the ï쳌¦ ï쳌¡ ï쳌¯ â?? s International Treaty on Plant able to negotiate exclusivity provisions freely . However , Genetic Resources for Food and Agriculture ( ï쳌© ï쳌´ ï쳌° ï쳌§ ï쳌² ï쳌¦ ï쳌¡ ) the Minister can also assess the fairness of exclusivity ( see Chapter ï?? ) . provisions in the contract against evidence of proper ï쳌° ï쳌© ï쳌£ , Concerns mutually agreed terms , and adequate benefit sharing . In The main concerns identified by the ï?? ï?? ï?? ï?? inquiry were : addition , contractual provisions of an exclusive nature a ) ownership of genetic resources ; b ) intellectual property which benefit the bioprospector should be reflected in the rights ( ï쳌© ï쳌° ï쳌² s ) and indigenous knowledge ; c ) benefit sharing ; amount of benefits payable to the provider of the genetic and d ) exclusivity issues . Ownership to genetic resources resource or traditional knowledge ( see Chapter ï?? ) . found in ex situ conditions was a significant issue for scientists , nongovernmental organizations ( ï쳌® ï쳌§ ï쳌¯ s ) , and Chile indigenous groups . Under common law , however , neither a holder nor a buyer can claim ownership to a plant or Process to the species or genus to which it belongs . The lack of Chile does not have an ï쳌¡ ï쳌¢ ï쳌³ policy yet . In early ï?? ï?? ï?? ï?? the clarity about ownership also applied to in situ resources Ministry of Agriculture developed a proposal for a law to under state and territory jurisdiction . In this case , leg - regulate access to agricultural genetic resources that could 2 islative details vary from state to state . Therefore the have facilitated the implementation of the ï쳌¦ ï쳌¡ ï쳌¯ â?? s ï쳌© ï쳌´ ï쳌° ï쳌§ ï쳌² ï쳌¦ ï쳌¡ , inquiry recommended that Biotechnology Australia and among other purposes . This proposal was developed with - the Attorney - Generalâ??s Department , in conjunction with out public consultation and it was discarded after much the state and territory governments , ensure that information criticism . However , efforts to develop a new proposal con - on the ownership of biological resources is compiled and tinue within the Ministry with support from the National made publicly available . Commission of the Environment ( ï쳌£ ï쳌¯ ï쳌® ï쳌¡ ï쳌­ ï쳌¡ ) . In ï?? ï?? ï?? ï?? , Indigenous groups were also concerned about the im - ï쳌£ ï쳌¯ ï쳌® ï쳌¡ ï쳌­ ï쳌¡ published the countryâ??s National Biodiversity pact of ownership or exclusive rights over ï쳌© ï쳌° ï쳌² s of these Strategy . It should be noted that the strategy emphasizes groups and on access for traditional uses . The inquiry stat - the need to develop legal instruments to regulate access ed that according to Australian law , ï쳌© ï쳌° ï쳌² s on any products to genetic resources to ensure fair participation in and eq - or processes derived from ex situ collections or resources uitable distribution of the benefits derived from their use . ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : S ï쳌£ ï쳌¥ ï쳌® ï쳌¡ ï쳌² ï쳌© ï쳌¯ ï쳌³ ï쳌¯ ï쳌¦ P ï쳌¯ ï쳌¬ ï쳌© ï쳌£ ï쳌¹ ï쳌­ ï쳌¡ ï쳌« ï쳌© ï쳌® ï쳌§ P ï쳌² ï쳌¯ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ The strategy was approved by the ï쳌£ ï쳌¯ ï쳌® ï쳌¡ ï쳌­ ï쳌¡ â?? s ministerial Convention on Biological Diversity states that a priority council ( which is the highest environmental policy body action for the country is to draft a genetic resources policy in the country ) and the National Biodiversity Action Plan or law that regulates ï쳌° ï쳌© ï쳌£ principles , benefit - sharing issues , was initiated in mid - ï?? ï?? ï?? ï?? . and ï쳌© ï쳌° ï쳌² s , among other issues . However , Chileâ??s recent experience in the access and In late ï?? ï?? ï?? ï?? , the State Council of China authorized the benefit - sharing debate goes back to the early ï?? ï?? ï?? ï?? s when State Environmental Protection Administration ( ï쳌³ ï쳌¥ ï쳌° ï쳌¡ ) to the countryâ??s genetic resources were accessed by several coordinate all issues regarding ï쳌¡ ï쳌¢ ï쳌³ issues to ensure the bioprospecting projects ( see Table ï?? of Chapter ï?? ) . These implementation of the ï쳌£ ï쳌¢ ï쳌¤ . Consequently , ï쳌³ ï쳌¥ ï쳌° ï쳌¡ is currently projects were briefly scrutinized by the press and local leading a national project to inventory all genetic resources ï쳌® ï쳌§ ï쳌¯ s and brought momentum for the analysis of ï쳌¡ ï쳌¢ ï쳌³ issues in China . This includes the participation of experts from at workshops . Government authorities also established a many organizations and universities from the agriculture , working group to discuss the issue and several meetings forestry , fishery , and medical sectors . Also , ï쳌³ ï쳌¥ ï쳌° ï쳌¡ is as - were held . In the long run , there were no significant results sembling a team to develop a comprehensive ï쳌¡ ï쳌¢ ï쳌³ policy from this initiative at a legislative or political level . This or law . Access and benefit - sharing issues are a new topic failure was due , in considerable part , to the complexity for Chinese authorities and they are looking for experi - of the subject . The process was stalled by the inability ence and case studies in foreign countries . Governmental to identify solutions to the issue of ownership of genetic officials from different ministries and experts designated resources and the absence of a national biodiversity policy . by the relevant ministries will participate in the ï쳌¡ ï쳌¢ ï쳌³ pro - But the main problem was a lack of political support among cess development . However , indigenous representatives legislative and executive decision makers to consider this a and foreign consultants are not likely to be invited to this matter of importance for the country ( see Chapter ï?? ï?? ) . process ( D . Xue , pers . comm . December ï?? ï?? ï?? ï?? ) . In mid - ï?? ï?? ï?? ï?? , the Foundation for International Environ - Concerns mental Law and Development ( ï쳌¦ ï쳌© ï쳌¥ ï쳌¬ ï쳌¤ ) and the Chilean ï쳌® ï쳌§ ï쳌¯ So far the main difficulties faced by the process have Fundación Sociedades Sustentables released the findings been the overlapping of functions and lack of coordina - of a project for an ï쳌¡ ï쳌¢ ï쳌³ policy in Chile . Some of the projectâ??s tion between the relevant ministries . ï쳌³ ï쳌¥ ï쳌° ï쳌¡ is responsible conclusions revealed the lack of technical capacity and for the implementation of the ï쳌£ ï쳌¢ ï쳌¤ , but ministries such as information about key ï쳌¡ ï쳌¢ ï쳌³ issues such as the protection the Ministry of Agriculture want to be in charge of access of traditional knowledge . Furthermore , the project found and benefit - sharing issues pertaining to crops , livestock , great contradictions among those that see the need to regu - and fishery production . In addition , there have been dif - late access to genetic resources and those that perceive such ficulties in defining beneficiaries from access activities . regulation as a strategy to legalize the misappropriation Should the state , ministry , organization , or individual of genetic resources and traditional knowledge . One of receive benefits derived from the countryâ??s genetic re - the most important recommendations of this project is sources ? How should these benefits be allocated ? ï쳌© ï쳌° ï쳌² s the need to develop a participatory process involving all are also likely to be a major concern and obstacle for the government and nongovernment stakeholders to facilitate development and implementation of legislation develop - 3 the development of an ï쳌¡ ï쳌¢ ï쳌³ policy for Chile . ment and implementation in the future . Chinese genetic Concerns resources have been used to develop inventions that have Between ï?? ï?? ï?? ï?? and ï?? ï?? ï?? ï?? , consultants were hired by ï쳌£ ï쳌¯ ï쳌® ï쳌¡ - been patented in other countries . Channeling benefits ï쳌­ ï쳌¡ to assess legal and political circumstances and propose derived from these inventions back to China is a problem a strategy for developing a national regulation for genetic that will be addressed by future legislation ( D . Xue , pers . resources . After internal debate , it was concluded that the comm . December ï?? ï?? ï?? ï?? ) . only way to initiate the development of ï쳌¡ ï쳌¢ ï쳌³ legislation was by addressing the issue of ownership of genetic re - Colombia , Ecuador , and Peru sources through legislative changes in the property regime Process of Chile . This conclusion prevented the implementation Colombia , Ecuador , and Peru , along with the other of further efforts because the Chilean Constitution gives members of the Andean Community , participated in the strong protection to private property and any modifica - development process of Decision ï?? ï?? ï?? . Initial discussions tions of this regime would require a legislative reform in for a regional ï쳌¡ ï쳌¢ ï쳌³ law included the participation of ï쳌® ï쳌§ ï쳌¯ s , Congress ( see Chapter ï?? ï?? ) . government organizations , and indigenous groups . The Secretariat of the Andean Community commissioned the China World Conservation Union , which subsequently involved Process the Peruvian Society for Environmental Law , to develop China , like most countries examined in this report , has a first draft of the issues that should be addressed by a 4 policies that regulate access to genetic resources , but regional access regulation . In mid - ï?? ï?? ï?? ï?? , a draft was com - these policies lack benefit - sharing provisions . Therefore , pleted . It received strong criticism and some governments Chinaâ??s ï?? ï?? ï?? ï?? National Report on implementation of the were opposed to having such a document as the basis for ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ discussion . Besides , other proposals had already emerged ï쳌¡ ï쳌¢ ï쳌³ discussions and consolidate regional efforts to reform Decision ï?? ï?? ï?? and facilitate its implementation . from various groups . In August ï?? ï?? ï?? ï?? , a Colombian non - governmental initiative developed a different proposal for a Concerns regional access and benefit - sharing law . These documents Should a regional ï쳌¡ ï쳌¢ ï쳌³ policy emphasize the biodiversity were discussed in a regional workshop in Colombia and conservation and sustainable development goals ? Or included wide participation ( ï쳌® ï쳌§ ï쳌¯ s , academic institu - should this policy focus on ï쳌¡ ï쳌¢ ï쳌³ issues in order to take ad - tions , private sector , intergovernmental institutions , and vantage of millions of dollars that could be obtained from indigenous organizations ) from the Andean countries . genetic resources ? This was one of the dilemmas faced by Nevertheless , there was increased tension in the debate stakeholders and policymakers at the beginning of the poli - about whether the proposal should implement the ï쳌£ ï쳌¢ ï쳌¤ as cymaking process and it was one of the sources of conflict a whole or just its specific ï쳌¡ ï쳌¢ ï쳌³ goals . Failure to come to an that stopped the participatory process . The potential loss agreement about this and other issues encouraged govern - of benefits was a major incentive for government officials ment representatives in charge of the initiative to pull away to develop an ï쳌¡ ï쳌¢ ï쳌³ proposal as soon as possible . from this participatory process . In addition , most govern - Protecting both traditional and scientific knowledge ments disliked the idea of discussing the development of was also a major concern addressed by some ï쳌® ï쳌§ ï쳌¯ s which an access norm based on an ï쳌® ï쳌§ ï쳌¯ proposal . advocated for a special access process and treatment for the Consequently , in November ï?? ï?? ï?? ï?? , the Colombian and cases that involved traditional knowledge . In the end , the Venezuelan governments jointly presented a new proposal governments proposed a solution that considers traditional for discussion . The following year , the governments of and scientific knowledge as an intangible component as - Bolivia and Ecuador proposed two different texts of draft sociated with genetic resources and a weak definition of the decisions and the discussions between government offi - protection of traditional knowledge . Decision ï?? ï?? ï?? provides cials evolved around these three governmental drafts . A a contractual approach to protect traditional knowledge but total of six meetings resulted in a final proposal that was delegates the development of a law to protecting traditional presented to the Commission of the Cartagena Agreement knowledge to future negotiations . The issue , however , is for its approval in July ï?? ï?? ï?? ï?? . very controversial and no regional proposal dealing spe - In synthesis , Decision ï?? ï?? ï?? lacked the input of a par - cifically with traditional knowledge has been officially ticipatory process where local ï쳌® ï쳌§ ï쳌¯ s , indigenous groups , discussed yet among the Andean countries . In the last and other stakeholders could have contributed to key stages of the development process of Decision ï?? ï?? ï?? there issues such as the protection of traditional knowledge . was intense discussion among government representatives The conflicting attitude between local ï쳌® ï쳌§ ï쳌¯ s and other about the scope of access activities . The agreed - upon defi - stakeholders led Andean governments to pull away from nition was based on a Colombian proposal , which is very the broad debate that characterized the early stages of the close to the current definition found in Decision ï?? ï?? ï?? ( see development of the ï쳌¡ ï쳌¢ ï쳌³ law . In addition , not all participat - Chapter ï?? ) . ing experts had adequate legal , technical , scientific , and economic experience to develop an access regime ( see Cook Islands Chapter ï?? ) . While Venezuela has been applying Decision ï?? ï?? ï?? , Process Colombia , Ecuador , and Peru have been working on na - Although this country has most of its traditional knowl - tional policies to facilitate the implementation of Decision edge associated with agricultural resources , these genetic ï?? ï?? ï?? with varying results . Colombia is working on a pro - materials are rarely endemic to the region . The main po - posal for an ï쳌¡ ï쳌¢ ï쳌³ policy that will be concluded in ï?? ï?? ï?? ï?? ( see tential that can be used by the pharmaceutical industry is Chapter ï?? ) . Peru developed a policy that was presented to associated with marine resources . Therefore any new ï쳌¡ ï쳌¢ ï쳌³ its National Environmental Council for approval in ï?? ï?? ï?? ï?? law will be targeted to this sector . and it could be adopted in ï?? ï?? ï?? ï?? ( M . Ruiz , pers . comm . Currently there are no national ï쳌¡ ï쳌¢ ï쳌³ policies that regulate January ï?? ï?? ï?? ï?? ) . Ecuador developed a policy in ï?? ï?? ï?? ï?? , but agricultural and marine resources . There is , however , a it was not approved and there are no initiatives to reac - code - of - conduct in effect under the taro germplasm proj - tivate the process ( J . Vogel , pers . comm . April ï?? ï?? ï?? ï?? ) . In ect , a regional genebank of taro ( Colocasia esculenta ) col - addition to these efforts , Peru and other Andean countries lected throughout the Pacific Islands under the auspices of 5 have proposed a general review of the text of Decision the Secretariat of the Pacific Community ( ï쳌³ ï쳌° ï쳌£ ) . This code ï?? ï?? ï?? to facilitate its implementation ( M . Ruiz , pers . comm . stipulates that the samples may not be used for commercial April ï?? ï?? ï?? ï?? ) . In ï?? ï?? ï?? ï?? , the Andean Community adopted a purposes without ï쳌° ï쳌© ï쳌£ . Regional Strategy on Biodiversity that includes an ï쳌¡ ï쳌¢ ï쳌³ At present the only national attempt to regulate ac - component . The strategy identifies some of the problems cess to bioprospectors is through a National Research of Decision ï?? ï?? ï?? and proposes measures to facilitate the Committee . The secretariat for this committee is the identification of solutions ( A ï쳌® ï쳌¤ ï쳌¥ ï쳌¡ ï쳌® C ï쳌¯ ï쳌­ ï쳌­ ï쳌µ ï쳌® ï쳌© ï쳌´ ï쳌¹ ï?? ï?? ï?? ï?? ) . Prime Ministers Office and its key governmental authori - TheAndean Community is currently working on an action ties in charge of agricultural , marine , cultural , and other plan for the strategy that might bring new momentum to issues . However , it rarely meets . The National Research ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : S ï쳌£ ï쳌¥ ï쳌® ï쳌¡ ï쳌² ï쳌© ï쳌¯ ï쳌³ ï쳌¯ ï쳌¦ P ï쳌¯ ï쳌¬ ï쳌© ï쳌£ ï쳌¹ ï쳌­ ï쳌¡ ï쳌« ï쳌© ï쳌® ï쳌§ P ï쳌² ï쳌¯ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ Committee issues a pre - research permit that is presented by Service only operates on the main island ( Rarotonga ) . The remaining islands , managed by Island Councils , the bioprospector to immigration authorities ( normally at are reluctant to have the central government apply an the international airport ) who issue a final research permit Environment Act to them . There has been a process of allowing access . However , few researchers go through this decentralizing government in order to give Island Councils process . Some exceptions include university students who as much autonomy as possible . Perhaps the alternative wish to reside in the country for periods that exceed three to the Environment Act would be a separate Access and months . Most researchers simply enter on a visitorâ??s visa Benefit - Sharing Act . But this has not been decided yet ( B . ( which actually restricts activities of research under the Ponia , pers . comm . February ï?? ï?? ï?? ï?? ) . Immigration Act ) issued at the port of entry . In the last few years , organizations such as the South Costa Rica Pacific Regional Environment Programme ( ï쳌³ ï쳌° ï쳌² ï쳌¥ ï쳌° ) , the World Wildlife Fund â?? South Pacific Program ( ï쳌· ï쳌· ï쳌¦ - ï쳌³ ï쳌° ï쳌° ) , Process and ï쳌¦ ï쳌© ï쳌¥ ï쳌¬ ï쳌¤ have created awareness about the ï쳌£ ï쳌¢ ï쳌¤ and The development process of the Law of Biodiversity No . the need to develop a national ï쳌¡ ï쳌¢ ï쳌³ law . In March ï?? ï?? ï?? ï?? , ï?? ï?? ï?? ï?? took about two years and revealed two opposing these organizations promoted a regional workshop on the positions . Some regarded legislating access as a way of implementation of the ï쳌£ ï쳌¢ ï쳌¤ in the Pacific Islands region promoting bioprospecting and legitimizing biopiracy while that produced a draft list of guidelines on ï쳌¡ ï쳌¢ ï쳌³ issues ad - others defended the law as a way to promote the sustainable opted by participants from ï?? ï?? Pacific Island countries that use of genetic resources . In ï?? ï?? ï?? ï?? , the first draft of the law included government organizations , ï쳌® ï쳌§ ï쳌¯ s , and academic was developed by Luis Martínez , a former president of institutions . the Environment Commission of the LegislativeAssembly A year later , ï쳌³ ï쳌° ï쳌² ï쳌¥ ï쳌° , ï쳌· ï쳌· ï쳌¦ - ï쳌³ ï쳌° ï쳌° , and ï쳌¦ ï쳌© ï쳌¥ ï쳌¬ ï쳌¤ organized a with technical support provided by the regional office for national workshop on ï쳌¡ ï쳌¢ ï쳌³ in the Cook Islands that devel - Mesoamerica of the World Conservation Union . The draft oped a list of recommendations for a national ï쳌¡ ï쳌¢ ï쳌³ law . The law was widely distributed to the public by mail and it meeting had widespread representation and publicity and was also made available on the internet ( J . Cabrera , pers . became an important turning point . Consequently , Cook comm.April ï?? ï?? ï?? ï?? ) . Many stakeholders considered this first Islands , under the leadership of the Ministry of Marine version to be particularly restrictive and opposed both to Resources , is currently working on a national ï쳌¡ ï쳌¢ ï쳌³ policy the public good and scientific research . that will go under a proposed National Environmental The Environment Commission made the second draft Act . The law is likely to be enforced by an Environment available in January ï?? ï?? ï?? ï?? . Even though this draft addressed Ministry , established under the Act or alternatively by some of the objections made to the first draft , it also re - the Office of the Prime Minister . Central government peated several of the contentious concepts stated in the ini - ministries regulate this type of national law . The Island tial version of the document . Therefore , it received similar Councils of the different inhabited islands and the mu - opposition . This situation led to the creation of a Special nicipal councils for the capital island may adopt by - laws Commission in the Legislative Assembly . Its mandate was that are managed under the Island Councils . to create a new draft , taking into consideration the previous This process will probably take about three years . ones . The Assembly promised to respect the outcome . It has benefited from the input of the Prime Ministers The Commission , led by Jorge Mora , Rector of the Office , Environment Service , Agriculture , Marine , National University , was established in April ï?? ï?? ï?? ï?? . It Culture , Education , and Justice sectors , Attorney General included the main political parties ( National Liberation Office , Representatives of Island Councils and Municipal and Social Christian Unity ) , the Advisory Commission Councils , indigenous bodies ( traditional healers and carv - on Biodiversity , the National Small Farmers Forum , the ers ) , and private sector lawyers . ï쳌³ ï쳌° ï쳌² ï쳌¥ ï쳌° also provided a tech - National Indigenous Forum , the Union of Chambers of nical staff familiar with ï쳌£ ï쳌¢ ï쳌¤ issues and a legal consultant Private Business , the University of Costa Rica , the National ( B . Ponia , pers . comm . February ï?? ï?? ï?? ï?? ) . University , the Costa Rican Federation for Environmental Conservation , and the National Biodiversity Institute . The Concerns Commission met until December ï?? ï?? ï?? ï?? when the new draft Major concerns include how to regulate access to ex situ was sent to Congress . It received the favorable opinion of collections and the perception that creating an access regu - the Environment Commission , and after a few modifica - lation actually encourages bioprospecting and the loss of tions , the Legislative Assembly approved the draft law in traditional knowledge . There are also mixed views on own - April ï?? ï?? ï?? ï?? during the last days of the administration of ership of genetic resources and the protection of traditional President Figueres Olsen . The Law of Biodiversity entered knowledge associated with medicinal plants . into force as Law of the Republic No . ï?? ï?? ï?? ï?? on ï?? May A major problem that also complicates the develop - ï?? ï?? ï?? ï?? ( see Chapter ï?? ) . ment of this participatory process is the lack of technical capacity . There is a great need to educate people about key Concerns ï쳌¡ ï쳌¢ ï쳌³ issues . But the main obstacle to this process is getting Time constraints for completing the draft law prevented the Environment Act passed . At present the Environment in - depth discussions of some of the most controversial ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ aspects such as ownership of genetic resources and ï쳌© ï쳌° ï쳌² s . In El Salvador addition , there were internal difficulties among the mem - Process bers of participating stakeholder groups . For example , ï쳌¡ ï쳌¢ ï쳌³ issues were placed on El Salvadorâ??s institutional representatives of the industry sector stated that since agenda by the ï?? ï?? ï?? ï?? National Biodiversity Strategy . The they were incapable of negotiating on behalf of all their strategy provided a participatory arena for the debate of associates , they would not vote for any of the proposals ï쳌¡ ï쳌¢ ï쳌³ issues among various sectors of society . In ï?? ï?? ï?? ï?? , with but would limit themselves to taking part in the debates financial support from the Global Environment Facility of the Commission . Since the law covered multiple policy ( ï쳌§ ï쳌¥ ï쳌¦ ) , the Environment Minister developed the follow - objectives , the possibility of dedicating sufficient time to ing four reports : a ) national assessment of genetic and ï쳌¡ ï쳌¢ ï쳌³ issues was diminished due to the pressing need to biochemical resources ; b ) capacity - building strategy for finalize a comprehensive draft . access to genetic and biochemical resources associated One of the most controversial issues was ownership of with wildlife ; c ) administrative procedures for access to genetic resources . Stakeholders such as representatives of genetic and biochemical resources ; and d ) policy guide - the farming sector criticized the fact that under the Law of lines on access to genetic and biochemical resources . These Biodiversity these resources were considered to be in the reports were developed by a variety of actors from gov - public domain , independent of private ownership of the ernment , peasant , and academic institutions . Then , these land . There were also concerns about integration between reports were submitted to the Presidency for review , ap - intellectual property and the procedures of the Law of proval , and adoption under a national policy on access to Biodiversity , since diverse exclusions have been estab - genetic and biochemical resources . The Presidency should lished . Compatibility of some of these exclusions with be adopting the policy sometime in ï?? ï?? ï?? ï?? . Subsequently , the Agreement on Trade - Related Aspects of Intellectual government sectors in charge of administering biological Property Rights ( ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ ) is an issue that needs careful con - resources ( e.g . , Agriculture Ministry ) will develop rules sideration . In the end , some of the patentability exclusions and procedures that must be followed by bioprospectors in were eliminated and others remained , in spite of warnings order to get access to these resources . The policy will also about their possible unconstitutionality ( see Chapter ï?? ) . be consistent with and supported by the Central American The development process for the Law of Biodiversity Protocol onAccess to Genetic and Biochemical Resources revealed a lack of technical expertise from certain sectors and their Associated Knowledge . The scope of the policy such as academic , indigenous , rural , political , and entre - will exclude genetic resources covered by the ï쳌¦ ï쳌¡ ï쳌¯ â?? s ï쳌© ï쳌´ ï쳌° - preneurial groups . Many of them used the process to make ï쳌§ ï쳌² ï쳌¦ ï쳌¡ that was already signed and ratified by El Salvador political rather than technical statements . Therefore , some ( J.E . Quezada - Díaz , pers . comm . January ï?? ï?? ï?? ï?? ) . The ï?? ï?? ï?? ï?? of the issues that may have needed a larger discussion fo - Environment Law provides the legal framework for the rum were addressed and defined by a few technocrats . For new ï쳌¡ ï쳌¢ ï쳌³ policy . Article ï?? ï?? of the law states that access , example , ï쳌© ï쳌° ï쳌² issues were debated by representatives from research , manipulation and use of genetic resources are business and academic groups in a Special Subcommittee allowed under permit , license , or concession granted by in charge of drafting the law . Concerns of indigenous the government agency in charge of administering and peoples that opposed the use of ï쳌© ï쳌° ï쳌² s were disregarded . managing the resource . In addition , discussions evolved around conceptual Concerns issues and ignored procedural , operative , or administra - Opportunities for stakeholders to participate in the de - tive issues that have impaired the full implementation of velopment process are limited by their lack of expertise . the law ( see Chapter ï?? ) . Several stakeholders argued that Many sectors of society do not realize the implications of since the National System of Conservation Areas had a a policy that regulates access and benefit - sharing issues . close relationship with the National Biodiversity Institute There is lack of information and misinterpretation about it should not be in charge of granting access permits and concepts such as equitable sharing of benefits , protection authorizations . Instead , this duty should have been given of traditional knowledge , and ï쳌© ï쳌° ï쳌² issues . The country has to a new commission able to represent the wider interest of yet to begin a process to address these issues properly and society . Other provisions such as the creation of a National carefully . Biological resources are owned by the State . Commission for the Management of Biodiversity ( ï쳌£ ï쳌¯ ï쳌® ï쳌¡ ï쳌§ ï쳌¥ - However , there is on - going debate about ownership is - ï쳌¢ ï쳌© ï쳌¯ ) were accepted under different proposals . According sues related to genetic resources . Financial support for the to the Law of Biodiversity , ï쳌£ ï쳌¯ ï쳌® ï쳌¡ ï쳌§ ï쳌¥ ï쳌¢ ï쳌© ï쳌¯ â?? s duties include development of the policy was provided by the ï쳌§ ï쳌¥ ï쳌¦ and the formulation of biodiversity and ï쳌¡ ï쳌¢ ï쳌³ policies and the additional funding will be required to build local capacity management of public funds . However , the Minister of to facilitate its implementation ( J.E . Quezada - Díaz , pers . the Environment and Energy considered these functions comm . January ï?? ï?? ï?? ï?? ) . unconstitutional and asked the Attorney Generalâ??s Office to submit a constitutional challenge that is currently under Honduras review . The suit does not suspend the execution of the Law of Biodiversity . However , politically , it has definitely Process delayed ï쳌£ ï쳌¯ ï쳌® ï쳌¡ ï쳌§ ï쳌¥ ï쳌¢ ï쳌© ï쳌¯ â?? s implementation of the law . In ï?? ï?? ï?? ï?? , under the leadership of the Natural Resources ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : S ï쳌£ ï쳌¥ ï쳌® ï쳌¡ ï쳌² ï쳌© ï쳌¯ ï쳌³ ï쳌¯ ï쳌¦ P ï쳌¯ ï쳌¬ ï쳌© ï쳌£ ï쳌¹ ï쳌­ ï쳌¡ ï쳌« ï쳌© ï쳌® ï쳌§ P ï쳌² ï쳌¯ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ and Environment Secretariat , the National Strategy on including the analysis of ï쳌¡ ï쳌¢ ï쳌³ laws enacted by other coun - Biodiversity was officially presented and one of its stra - tries . The working group has also organized workshops to tegic components was the ï쳌¡ ï쳌¢ ï쳌³ issue . The strategy was facilitate the debate and contribute to the identification of the product of nine regional workshops that included the key issues . Participants include representatives from the participation of indigenous communities , industry , peas - Ministry of Agriculture , Ministry of Forestry , Ministry ants , and government organizations . The strategy created of Justice and Human Rights , Ministry of Environment , momentum for additional discussions on ï쳌¡ ï쳌¢ ï쳌³ issues . But it Ministry of Research and Technology , Indonesian Institute is not clear how ï쳌¡ ï쳌¢ ï쳌³ goals will be incorporated into national of Science , local universities , ï쳌® ï쳌§ ï쳌¯ s , and national experts . law . Some advocate for a comprehensive law similar to There are no foreign consultants involved in the process , the Costa Rican Law of Biodiversity . However , there is but the ï?? ï?? ï?? ï?? Bonn Guidelines on ï쳌¡ ï쳌¢ ï쳌³ are being used to also a possibility to develop a single ï쳌¡ ï쳌¢ ï쳌³ law . This is one guide the process . Before the draft law is sent to Congress of the issues to be discussed in future meetings . An initial it should be available for public comment ( B.S . Wardhana , discussion of ï쳌¡ ï쳌¢ ï쳌³ issues already begun at a government pers . comm . March ï?? ï?? ï?? ï?? ) . level and a preliminary draft has been developed . Next Concerns steps will include developing a final draft together with The main challenge is likely to be the resolution of relevant stakeholders consulted at a national level ( J.A . controversial issues that include ownership of genetic Fuentes , pers . comm . June ï?? ï?? ï?? ï?? ) . resources , indigenous knowledge , and the relationship be - Concerns tween traditional ï쳌© ï쳌° ï쳌² systems and traditional knowledge . The lack of technical capacity is one of the main obstacles For example , the national constitution states that natural that the ï쳌¡ ï쳌¢ ï쳌³ development process will face in the future . resources ( including genetic resources ) are owned by the The relationship between traditional property rights and State . However , since local communities have used these indigenous knowledge was one of the main concerns ad - resources traditionally without major restrictions they be - dressed during initial discussions of the draft ï쳌¡ ï쳌¢ ï쳌³ policy . lieve that they hold ownership over them ( B.S . Wardhana , A great deal of debate went also into details about how to pers . comm . March ï?? ï?? ï?? ï?? ) . protect indigenous knowledge . Issues debated included : a ) the number of years of protection provided by the system ; Malaysia b ) the individual or collective nature of indigenous knowl - edge ; c ) strategies to protect indigenous knowledge ; and Process d ) the relationship between trade secrets and traditional The development of the draft law on Access to Genetic knowledge . This discussion included also procedural is - Resources has promoted an interesting cooperation among sues such as identifying the characteristics of the govern - federal and state authorities . This process began in ï?? ï?? ï?? ï?? ment agency in charge of administering this system ( J.A . with the establishment of the National Committee on Fuentes , pers . comm . June ï?? ï?? ï?? ï?? ) . Biological Diversity , which supported by the Attorney - General , played a significant role in the development of the Indonesia draft law ( see Table ï?? of Chapter ï?? ï?? ) . The process received ample input during a National Workshop on Access and Process Benefit Sharing of Genetic Resources held in ï?? ï?? ï?? ï?? ( see Indonesia is currently working on a draft law , the Act on Box ï?? of Chapter ï?? ï?? ) . Two years later a task force , estab - Genetic Resource Management that includes a regulation lished by a National Technical Committee on Biological on ï쳌¡ ï쳌¢ ï쳌³ issues . This law will be comprehensive and the Diversity , completed the final text of the draft law . provisions will be consistent with existing laws on agri - Presently , the Ministry of Science , Technology , and culture , forestry , and biodiversity . The government is also the Environment ( ï쳌­ ï쳌¯ ï쳌³ ï쳌´ ï쳌¥ ) , in close collaboration with the conducting an assessment of existing legal instruments Attorney - Generalâ??s Chambers , is handling the whole pro - that regulate ï쳌¡ ï쳌¢ ï쳌³ issues . Local officials estimate that ï쳌¡ ï쳌¢ ï쳌³ cess from the final draft bill to the passing of the draft bill legislation will be concluded in ï?? ï?? ï?? ï?? . into law . This draft bill was scheduled to go through the The act will have a national scope , but provincial national consultation process in ï?? ï?? ï?? ï?? and ï?? ï?? ï?? ï?? , then to the or district level governments should develop their own Cabinet for approval , and finally to the Parliament for the regulations that must be formulated in line with the bill to be passed into law . However , the process has pro - national law . The law will apply to the pharmaceutical , gressed at a relatively slower pace particularly with regard agricultural , botanical medicine , biotechnology , and other to national consultation . Furthermore ï쳌­ ï쳌¯ ï쳌³ ï쳌´ ï쳌¥ gave priority pertinent sectors . The Act will also be compatible with to enacting the Biosafety Bill into law . Consequently , the the ï쳌¦ ï쳌¡ ï쳌¯ â?? s ï쳌© ï쳌´ ï쳌° ï쳌§ ï쳌² ï쳌¦ ï쳌¡ that Indonesia should be signing and draft is not expected to be adopted by the government ratifying soon . until ï?? ï?? ï?? ï?? or even later . Favorable comments from the As the focal point for the ï쳌£ ï쳌¢ ï쳌¤ , the Ministry for the 6 states of Sabah and Sarawak among others , is crucial Environment established an inter - ministerial working to facilitate the completion and adoption of the draft law group to formulate this law . This working group was or - ganized into smaller groups in charge of technical tasks ( see Chapter ï?? ï?? ) . ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ Concerns Nicaragua A major issue debated during the development process Process that needs to be clarified further is ownership of genetic The process of developing the draft Law of Biodiversity resources . In Malaysia , there are biological resources was initiated in ï?? ï?? ï?? ï?? by the national strategy for the con - found on public lands that belong to federal and state gov - servation of biodiversity and briefly supported in ï?? ï?? ï?? ï?? ernments . In some states , ownership rights of biological by a proposal from the Ministry for the Environment and resources found in indigenous or community - held land , Natural Resources ( ï쳌­ ï쳌¡ ï쳌² ï쳌¥ ï쳌® ï쳌¡ ) . In ï?? ï?? ï?? ï?? , ï쳌­ ï쳌¡ ï쳌² ï쳌¥ ï쳌® ï쳌¡ reactivated belong to the community and ownership rights over tradi - the ï?? ï?? ï?? ï?? proposal with financial support from the World tional knowledge and innovations still need to be clarified . Conservation Union , the United Nations Development ï쳌© ï쳌° ï쳌² systems for the protection of biological organisms and Programme , the Mesoamerican Biological Conservation traditional knowledge were also major points of discussion . Corridor , and the government of Nicaragua . Subsequently , A sui generis system of community intellectual rights was an interdisciplinary team of national and international proposed but it was not included in the draft bill because it experts from Peru , Mexico , Argentina , Costa Rica , and turned out to be very controversial . In addition , stakehold - Nicaragua developed the draft Law of Biodiversity . ers opposed the use of patents to protect genes , plants , and Representatives of more than ï?? ï?? % of Nicaraguan in - other organisms . digenous communities participated in this process . They In addition , several procedural and conceptual issues played a pivotal role in the development of one of the most discussed during the design of the draft law remain un - controversial and novel provisions of the draft Law of resolved . Tasks that remain to be tackled before the draft Biodiversity that calls for the development of a sui generis bill is passed into law include : a ) determining the federal system for the protection of the knowledge , practices and authority in charge of matters relevant to biological diver - innovations of local communities . In ï?? ï?? ï?? ï?? , the draft was sity ; b ) ensuring uniformity in relevant state laws ; c ) deter - available for comment to a group of ï?? ï?? specialists from mining the institutional structure for the implementation of ï쳌® ï쳌§ ï쳌¯ s and government organizations that suggested the inclusion of biosafety , wildlife , and environmental issues the draft bill ; d ) determining the competent authorities and into the proposal . Most recently , indigenous communities , negotiating partners to identify and address the interests ï쳌® ï쳌§ ï쳌¯ s , and industry representatives had the opportunity to of the holders of indigenous knowledge ; and e ) ensuring provide additional input and contribute to the final draft . adequate participation of indigenous representatives in In late ï?? ï?? ï?? ï?? , Government officials completed a final draft the development of ï쳌° ï쳌© ï쳌£ procedures and benefit - sharing that should be sent to Congress in ï?? ï?? ï?? ï?? ( J . Hernandez , requirements ( see Chapter ï?? ï?? ) . pers . comm . February ï?? ï?? ï?? ï?? ) . Mexico Concerns Traditional knowledge , ï쳌© ï쳌° ï쳌² s , ownership of genetic re - Process sources , biosafety , and procedural issues have been the The ï?? ï?? ï?? ï?? reform of the ï?? ï?? ï?? ï?? Ecological Equilibrium and main topics of heated discussion during the development Environment Protection General Act ( ï쳌¥ ï쳌¥ ï쳌¥ ï쳌° ï쳌§ ï쳌¡ ) introduced process of the law . The protection of traditional knowl - article ï?? ï?? ï쳌¢ ï쳌© ï쳌³ that regulates access and benefit sharing edge was so controversial that some government officials for biotechnology purposes . This reform was carried from the Ministry of Industry and Commerce opposed its out in ï?? ï?? months by the Commissions of Ecology and inclusion into the draft law . In June ï?? ï?? ï?? ï?? , however , resolu - Environment of the Senate and House of Representatives tions of the ï쳌£ ï쳌¢ ï쳌¤ and guidelines of the World Intellectual and the Secretariat of Environment and Natural Resources Property Organization endorsing strategies to protect tra - ( ï쳌³ ï쳌¥ ï쳌­ ï쳌¡ ï쳌² ï쳌® ï쳌¡ ï쳌´ ) . The reform promoted by these organizations ditional knowledge provided convincing arguments and was the result of a small process of consultation that in - this provision remained in the draft law . cluded few stakeholders . This process , nonetheless , facili - While the draft law states that genetic resources are tated the approval of one ï쳌¡ ï쳌¢ ï쳌³ provision and other measures in the public domain , it provides indigenous communi - that reformed the ï쳌¥ ï쳌¥ ï쳌¥ ï쳌° ï쳌§ ï쳌¡ ( J . Larson and C . López - Silva , ties with ownership rights to genetic resources found in pers . comm . January ï?? ï?? ï?? ï?? ) . their lands . This property right distinction is likely to be controversial when the draft law reaches Congress . Concerns Policymakers are also uncertain about how to address the Issues such as ownership of genetic resources and the new commitments of the ï쳌¦ ï쳌¡ ï쳌¯ â?? s ï쳌© ï쳌´ ï쳌° ï쳌§ ï쳌² ï쳌¦ ï쳌¡ that was acceded protection of traditional knowledge were not properly to by Nicaragua in November ï?? ï?? ï?? ï?? . discussed and addressed by the reform of the ï쳌¥ ï쳌¥ ï쳌¥ ï쳌° ï쳌§ ï쳌¡ . But perhaps the main problem is a current disagreement These legal gaps and the lack of a nation - wide participatory between the Environment Ministry and theAgriculture and process of discussion of the reform may have provided im - Forestry Ministry about jurisdictional powers over access petus for the public opposition that led to the cancellation to genetic resources for agricultural purposes and biosafety of access granted under the law to several bioprospecting issues . The Agriculture and Forestry Ministry argues that projects ( see Chapter ï?? ) . they handle biosafety issues and that a stand - alone law of ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : S ï쳌£ ï쳌¥ ï쳌® ï쳌¡ ï쳌² ï쳌© ï쳌¯ ï쳌³ ï쳌¯ ï쳌¦ P ï쳌¯ ï쳌¬ ï쳌© ï쳌£ ï쳌¹ ï쳌­ ï쳌¡ ï쳌« ï쳌© ï쳌® ï쳌§ P ï쳌² ï쳌¯ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌¥ ï쳌² biosafety just like the Peruvian proposal should address includes the establishment of a system to regulate access to genetic resources in indigenous lands and a mechanism them . The Environment Ministry responds that biosafety is to ensure the equitable sharing of benefits derived from the one of the main provisions of the ï쳌£ ï쳌¢ ï쳌¤ and as such it should use of these resources . The draft law also includes penal - be included in the Law of Biodiversity . In addition , there ties , ï쳌° ï쳌© ï쳌£ requirements , the right of indigenous groups to is overlapping between the draft Law of Biodiversity and deny access to their genetic resources , and the intellectual existing laws . The draft law includes provisions about inva - protection of indigenous knowledge.According to the draft sive and domestic species , issues that are already regulated law , indigenous knowledge or genetic resources used by by the Law of Production and Commerce of Seeds and the traditional communities will not be entitled to ï쳌© ï쳌° ï쳌² protec - Law of Animal and Plant Sanitation ( J . Hernandez , pers . tion . ï쳌© ï쳌° ï쳌² protection such as patents for any product derived comm . February ï?? ï?? ï?? ï?? ) . from access activities in indigenous lands will require the authorization of indigenous leaders and the proposed in - Panama stitute . The process to pass draft Law No . ï?? ï?? is currently Process on hold due to several factors that include budgetary Currently , Panama does not have a clear and comprehen - constrains . However , in late ï?? ï?? ï?? ï?? the Ministry of Health created a unit on traditional indigenous medicine that will sive ï쳌¡ ï쳌¢ ï쳌³ law . However , in the last few years the National address some of the issues proposed by the draft law . Authority for the Environment ( ï쳌¡ ï쳌® ï쳌¡ ï쳌­ ) has been using a In ï?? ï?? ï?? ï?? , Panama adopted a sui generis system for the contractual approach to facilitate access to bioprospecting protection of community intellectual rights that is among projects . The ï?? ï?? ï?? ï?? Bonn Guidelines on ï쳌¡ ï쳌¢ ï쳌³ have been the first in the region . Law ï?? ï?? of ï?? ï?? June ï?? ï?? ï?? ï?? established employed in the negotiation of these projects and will a special regime for the intellectual protection of commu - be followed in the development of future national ï쳌¡ ï쳌¢ ï쳌³ nity rights , cultural identity , and traditional knowledge . regulations . The law provides protection to traditional knowledge The development process of ï쳌¡ ï쳌¢ ï쳌³ laws and policies of indigenous groups that include customs , models , started with the ï?? ï?? ï?? ï?? General Law of the Environment drawings , music , art , and other inventions , through a No . ï?? ï?? ( ï쳌§ ï쳌¬ ï쳌¥ ) that designated ï쳌¡ ï쳌® ï쳌¡ ï쳌­ as the competent registry system . The Division of Industrial Property of authority for the regulation , management , and control of the Ministry of Commerce and Industry administers the the access to and use of biogenetic resources . According system . Registration is voluntary , free of charge , and there to ï쳌§ ï쳌¬ ï쳌¥ , ï쳌¡ ï쳌® ï쳌¡ ï쳌­ had to develop the legal instruments and are no time limits for the protection provided by the reg - economic mechanisms to facilitate ï쳌¡ ï쳌¢ ï쳌³ goals in Panama istry . The registry will not prevent the continuous use of ( L ï쳌¡ A ï쳌³ ï쳌¡ ï쳌­ ï쳌¢ ï쳌¬ ï쳌¥ ï쳌¡ L ï쳌¥ ï쳌§ ï쳌© ï쳌³ ï쳌¬ ï쳌¡ ï쳌´ ï쳌© ï쳌¶ ï쳌¡ ï?? ï?? ï?? ï?? ) . In ï?? ï?? ï?? ï?? , ï쳌¡ ï쳌¢ ï쳌³ discus - traditional knowledge but it will protect it from being used sions reached new momentum with the adoption of the by others without previous authorization or compensation . National Strategy for the Environment that proposed a Policymakers are currently working on a regulation for the long - term vision for biodiversity issues . This vision was law that will include monitoring requirements and compen - reinforced by the ï?? ï?? ï?? ï?? National Biodiversity Strategy sation provisions such as royalties and up - front payments that proposed the implementation of ï쳌¡ ï쳌¢ ï쳌³ principles . In if indigenous knowledge is used by third parties.Additional addition to this effort , the National Biodiversity Action work is also taking place on a draft law for the protection Plan proposed , as one of the ï?? ï?? goals for year ï?? ï?? ï?? ï?? , the of the collective rights of local communities to protect the equitable distribution of benefits derived from the use of biological , medical , and ecological knowledge of indigenous biological diversity among all sectors of society . Actions peoples ( M . Dimas , pers . comm February ï?? ï?? ï?? ï?? ) . to implement this goal have been focused on three main fronts : a ) the ratification of the Central American Protocol Concerns onAccess to Genetic and Biochemical Resources and their Lack of technical capacity , pertinent information , and mis - associated knowledge that should take place in ï?? ï?? ï?? ï?? ; b ) trust from indigenous groups are some of the concerns and the development of a national wildlife trust fund that will obstacles facing the development process of ï쳌¡ ï쳌¢ ï쳌³ laws in facilitate the distribution of benefits derived from the use Panama . These issues have contributed to controversial of genetic resources ; and c ) the development of new ï쳌¡ ï쳌¢ ï쳌³ and heated debates about ownership of genetic resources , procedures that will be adopted by the executive branch . traditional knowledge , and ï쳌© ï쳌° ï쳌² s . There are still many over - Since late ï?? ï?? ï?? ï?? Panama has been working on a policy to lapping issues and judicial obstacles that policymakers fill the gaps present in existing legislation regarding ï쳌¡ ï쳌¢ ï쳌³ will have to overcome in order to develop a comprehensive and cohesive ï쳌¡ ï쳌¢ ï쳌³ system . Panama has not signed the ï쳌¦ ï쳌¡ ï쳌¯ â?? s and indigenous knowledge issues . Representatives from the ï쳌© ï쳌´ ï쳌° ï쳌§ ï쳌² ï쳌¦ ï쳌¡ and it is uncertain how national laws and policies agriculture , biotechnology , industry , and indigenous groups will assimilate the treaty requirements ( M . Dimas , pers . have been participating in workshops . Foreign consultants comm . February ï?? ï?? ï?? ï?? ) . from the Central American Commission on Environment and Development have also supported this process . Philippines In parallel with the above process , there has been an initiative promoted by the Commission of Indigenous Process Affairs since ï?? ï?? ï?? ï?? , to complete draft Law No . ï?? ï?? . This The history of ï쳌¡ ï쳌¢ ï쳌³ policies in the Philippines has been ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ marked by two significant events : the adoption of the ï?? ï?? ï?? ï?? Department of Trade and Industry , National Committee on Executive Order ï?? ï?? ï?? ( ï쳌¥ ï쳌¯ ï?? ï?? ï?? ) and the enactment of the Biosafety in the Philippines , and the ï쳌¡ ï쳌³ ï쳌¥ ï쳌¡ ï쳌® Regional Center ï?? ï?? ï?? ï?? Wildlife Resources and Conservation Act ( hereafter , for Biodiversity Conservation ) ; academia ( University of Wildlife Act ) . The act included only two articles about ac - the Philippines ( ï쳌µ ï쳌° ) Marine Science Institute and the cess and benefit - sharing issues , but it addressed many of Institute of Plant Breeding - ï쳌µ ï쳌° Los Baños ) ; business the criticisms made of ï쳌¥ ï쳌¯ ï?? ï?? ï?? and modified it substantially . ( Floratrade / Philippine Horticultural Society and Southeast However , ï쳌¥ ï쳌¯ ï?? ï?? ï?? is still quite relevant for the regulation of Asian Fisheries Development Corp ) ; and ï쳌® ï쳌§ ï쳌¯ s ( Kalikasan bioprospecting activities ( see Chapters ï?? and ï?? ) . Mindoro Foundation and Conservation International ) . The development process of ï쳌¥ ï쳌¯ ï?? ï?? ï?? can be traced Participants were in full support of the WildlifeAct and back to the ï?? ï?? ï?? ï?? Seventh Asian Symposium on Medicinal acknowledged its potential to facilitate and streamline ï쳌¡ ï쳌¢ ï쳌³ Plants , Species , and Other Natural Products held in the procedures . Most of the concerns or criticisms against ï쳌¥ ï쳌¯ Philippines . Two of the main outcomes of the Symposium ï?? ï?? ï?? were considered and accommodated . There were also were the Manila Declaration entitled â?? The Ethical no controversial provisions or issues . ï쳌¤ ï쳌¥ ï쳌® ï쳌² redrafted the Utilization ofAsian Biological Resources â?쳌 , and the â?? Code Wildlife Actâ??s provisions on bioprospecting . This is the of Ethics for Foreign Collectors of Biological Samples and same agency primarily in charge of implementing ï쳌¥ ï쳌¯ ï?? ï?? ï?? Contract Guidelines â?쳌 . These two documents and the ï쳌£ ï쳌¢ ï쳌¤ ( See Chapters ï?? and ï?? ) . In July ï?? ï?? ï?? ï?? , the draft â?? Guidelines created great awareness about the issue of bioprospecting for Bioprospecting Activities in the Philippines â?쳌 were re - inAsian countries and encouraged the Philippine Network leased by ï쳌¤ ï쳌¥ ï쳌® ï쳌² for public review and comment . These for the Chemistry of Natural Products in Southeast Asia guidelines were based on national consultations and ( with financial support from ï쳌µ ï쳌® ï쳌¥ ï쳌³ ï쳌£ ï쳌¯ ) to develop the first interagency meetings . If adopted , the guidelines would draft of ï쳌¥ ï쳌¯ ï?? ï?? ï?? . Subsequently , in October ï?? ï?? ï?? ï?? , Antonio facilitate the implementation of the Wildlife Act and those G.M . La Viña , a legal consultant , was invited to revise the provisions of ï쳌¥ ï쳌¯ ï?? ï?? ï?? not repealed by the Wildlife Act . draft with input from members of the Philippine Network Concerns and representatives of key government departments . The The main difficulty experienced during the design of ï쳌¥ ï쳌¯ ï쳌¥ ï쳌¯ ï?? ï?? ï?? was adopted by the Philippines in ï?? ï?? ï?? ï?? . In ï?? ï?? ï?? ï?? , ï?? ï?? ï?? was the lack of experience of policymakers , both implementing rules and regulations for ï쳌¥ ï쳌¯ ï?? ï?? ï?? were de - domestically and internationally . Another concern was veloped under the aegis of La Viña who was appointed its impact on domestic research . Getting all the agencies under - secretary of the Department of Environment and and stakeholders that should be engaged and involved in Natural Resources ( ï쳌¤ ï쳌¥ ï쳌® ï쳌² ) . Drafts were circulated for com - drafting ï쳌¥ ï쳌¯ ï?? ï?? ï?? to commit the time and resources for the ments to stakeholders that included government agencies , process was difficult . As noted above , the first draft of ï쳌¥ ï쳌¯ universities , private organizations , and ï쳌® ï쳌§ ï쳌¯ s . The secretary ï?? ï?? ï?? came from a group of scientists ( a network of Natural of ï쳌¤ ï쳌¥ ï쳌® ï쳌² signed a final version in mid - ï?? ï?? ï?? ï?? . The high level Chemistry professors and researchers ) , and promoting sub - of participation in the development of ï쳌¥ ï쳌¯ ï?? ï?? ï?? was quite sequent support of the initiative by government agencies unusual for an executive order in the Philippines , which was difficult . usually requires only limited consultation . In this case , rep - The process had to overcome several procedural and resentatives of government , scientists , nongovernmental technical issues and perhaps the most difficult one was organizations , community organizations , and the business determining the scope of the regulation . Other challenges community were actively involved in the drafting through included funding and sanctions . In addition , it was dif - a number of consultative meetings ( A.G.M . La Viña , pers . ficult to determine a strategy to encourage self - regulation comm . March ï?? ï?? ï?? ï?? ) . within the domestic academic community so that ï쳌¥ ï쳌¯ ï?? ï?? ï?? In ï?? ï?? ï?? ï?? , the ï?? ï?? th Congress passed the Wildlife Act . would not become a bureaucratic nightmare for legitimate The process began in ï?? ï?? ï?? ï?? , when five House bills were researchers . The Academic Research Agreement was con - filed and consolidated into one bill . A similar bill was ceptualized as the way to deal with this concern . Under filed in the Senate . The lower house version was used as this concept , researchers within an institution need apply a working draft during the bicameral committee sessions . for access only with that institution and not separately Since the Wildlife Act is actually a codification of exist - with the government . Putting together the administrative ing laws on the protection and conservation of wildlife machinery for implementation was also a difficult problem resources , experience with the implementation of exist - as there are many agencies with some aspect of jurisdic - ing laws helped greatly in the design of the Wildlife Act . tion over bioprospecting activities ( A.G.M . La Viña , pers . Concerns and issues raised against old laws such as ï쳌¥ ï쳌¯ comm . March ï?? ï?? ï?? ï?? ) . ï?? ï?? ï?? were addressed in the act . Some of the concerns voiced during discussion of the The following sectors participated during the dis - Wildlife Act included : a ) the need to simplify the permit - cussion process : government ( Bureau of Customs , ting system for noncommercial research and development ; Philippine National Museum , Department of Science b ) the need to provide a list of species that are banned and and Technology , Bureau of Aquatic Resources , National restricted for prosecution purposes ; c ) government agen - Bureau of Investigation , Protected Areas and Wildlife Bureau , Ecosystems Research and Development Bureau , cies mandated to do research had to be exempted from ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : S ï쳌£ ï쳌¥ ï쳌® ï쳌¡ ï쳌² ï쳌© ï쳌¯ ï쳌³ ï쳌¯ ï쳌¦ P ï쳌¯ ï쳌¬ ï쳌© ï쳌£ ï쳌¹ ï쳌­ ï쳌¡ ï쳌« ï쳌© ï쳌® ï쳌§ P ï쳌² ï쳌¯ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ securing permits for collection ; e ) species listed under the associated with access to and benefit sharing of genetic Convention on International Trade in Endangered Species resources . Early discussions on the Act on the Protection of Wild Fauna and Flora should be prohibited from ex - and Promotion of Traditional Medicinal Intelligence ( ï쳌¡ ï쳌° - ploitation except for scientific , education , experimental ï쳌° ï쳌´ ï쳌­ ï쳌© ) also took place in ï?? ï?? ï?? ï?? when ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ was concluded breeding , and propagation purposes ; and f ) the need to and Thailand learned about its commitments regarding the ensure that bioprospectors comply with the Cartagena need for a protection mechanism of plant varieties . Protocol on Biosafety when samples are imported ( see The development process of the ï쳌° ï쳌¶ ï쳌° ï쳌¡ took two years . Chapter ï?? ) . The drafting process was initiated by the Ministry of Agriculture and Cooperatives in ï?? ï?? ï?? ï?? during the govern - ment of Prime Minister Chavalit Yongchaiyudh and it Samoa was passed into law in ï?? ï?? ï?? ï?? while Prime Minister Chuan Process Leekpai was in office . The process was initiated with brain - Since the mid - ï?? ï?? ï?? ï?? s , Samoa has been carrying out initia - storming sessions among government officials resulting tives to implement the ï쳌£ ï쳌¢ ï쳌¤ . In ï?? ï?? ï?? ï?? , policymakers initi - in a working group that brought together policymakers , ated development of a draft National Biodiversity Strategy ï쳌® ï쳌§ ï쳌¯ s , researchers , private sector representatives , lawyers , 7 that was not completed due to lack of funding . In ï?? ï?? ï?? ï?? , and academics to work on the drafting of the act . The however , thanks to financial support provided by the ï쳌§ ï쳌¥ ï쳌¦ , first draft was discussed at a public hearing , amendments the draft was revised , improved , and completed becom - were made , and it was sent off to the Parliament . A major ing part of the National Biodiversity Strategy and Action obstacle to the process was that Parliament was dissolved Plan ( ï쳌® ï쳌¢ ï쳌³ ï쳌¡ ï쳌° ) . The ï쳌® ï쳌¢ ï쳌³ ï쳌¡ ï쳌° was adopted by Samoa in April while the draft law was being discussed . The draft law was ï?? ï?? ï?? ï?? and provided the conceptual and strategic founda - sent back to government and officials used this opportunity tion for the parallel and future efforts on ï쳌¡ ï쳌¢ ï쳌³ issues that to modify some of the provisions unilaterally . However , have been supported since ï?? ï?? ï?? ï?? by ï쳌· ï쳌· ï쳌¦ - ï쳌³ ï쳌° ï쳌° and ï쳌³ ï쳌° ï쳌² ï쳌¥ ï쳌° . in the end , compromises were made between government In March ï?? ï?? ï?? ï?? , these organizations and ï쳌¦ ï쳌© ï쳌¥ ï쳌¬ ï쳌¤ held in Fiji officials and stakeholders , the draft was resubmitted to the a regional workshop on the implementation of the ï쳌£ ï쳌¢ ï쳌¤ in next Parliament and passed into law ( J . Donavanik , pers . the Pacific Islands region . Participants at the workshop comm . January ï?? ï?? ï?? ï?? ) . included government organizations , ï쳌® ï쳌§ ï쳌¯ s , and academic Between ï?? ï?? ï?? ï?? and ï?? ï?? ï?? ï?? , ï쳌² ï쳌¦ ï쳌¤ officials that included institutions . forestry experts and lawyers developed the ï쳌² ï쳌¦ ï쳌³ ï쳌² ï쳌£ ï쳌¦ ï쳌¡ . The workshop produced a draft list of guidelines Prompted by complaints from researchers about extremely on ï쳌¡ ï쳌¢ ï쳌³ issues that was adopted by participants from ï?? ï?? long application times for access permits , among other Pacific Island countries . As a result of this workshop and reasons , ï쳌² ï쳌¦ ï쳌¤ set up a Technical Committee in October ï?? ï?? ï?? ï?? the regional guidelines the Department of Lands , Surveys , to advise the Director General . The Technical Committee and Environment of Samoa adopted the ï?? ï?? ï?? ï?? â?? Conditions met several times in ï?? ï?? ï?? ï?? and early ï?? ï?? ï?? ï?? and discussions for Access to and Benefit Sharing of Samoaâ??s Biodiversity focused on developing a regulation to facilitate access for Resources â?쳌 . The conditions , however , are likely to be researchers to state - owned forested areas . In April ï?? ï?? ï?? ï?? , a replaced by a draft bioprospecting regulation that will Research Proposal Reviewing Subcommittee ( RPRS ) was become part of the ï?? ï?? ï?? ï?? Lands and Environment Act ( C . set up under the Technical Committee to examine issues Schuster and D.M . Clarke pers . comm . November ï?? ï?? ï?? ï?? ) . related with the upcoming access regulation . In September ï?? ï?? ï?? ï?? , the ï쳌² ï쳌¦ ï쳌¤ released and adopted the ï쳌² ï쳌¦ ï쳌³ ï쳌² ï쳌£ ï쳌¦ ï쳌¡ . In ï?? ï?? ï?? ï?? , a Concerns second unit was split out from the ï쳌² ï쳌¦ ï쳌¤ , the Department of Lack of funding and local capacity , ownership of ge - National Parks , Wildlife , and Plant Conservation ( ï쳌¤ ï쳌® ï쳌· ï쳌° ) . netic resources and traditional knowledge , and the impact In late ï?? ï?? ï?? ï?? , both departments were put under the aegis of ï쳌© ï쳌° ï쳌² s are some of the concerns and difficulties faced by of the Ministry of Natural Resources and Environment . stakeholders and policymakers of Samoa . Many stakehold - Under the new scheme the general directors of ï쳌² ï쳌¦ ï쳌¤ and ers oppose the patenting of knowledge and have concerns ï쳌¤ ï쳌® ï쳌· ï쳌° regulate access to natural , biological , and genetic about the impact of ï쳌© ï쳌° ï쳌² s on the conservation of biodiversity resources found in forest and protected areas of Thailand ( C . Schuster , pers . comm . November ï?? ï?? ï?? ï?? ) . ( C . Hutacharern , pers . comm . December ï?? ï?? ï?? ï?? ) . In ï?? ï?? ï?? ï?? , the Institute of Traditional Thai Medical Thailand Practice ( Ministry of Public Health ) initiated the devel - opment process of the ï쳌¡ ï쳌° ï쳌° ï쳌´ ï쳌­ ï쳌© . The process included the Process participation of traditional healers , specialists in herbal Origins of the development process of the ï?? ï?? ï?? ï?? Plant medicines , and experts in the development process of tra - Variety Protection Act ( ï쳌° ï쳌¶ ï쳌° ï쳌¡ ) and the Royal Forest ditional medicines . Other participants included lawyers , Department ( ï쳌² ï쳌¦ ï쳌¤ ) Regulation on Forestry Studying and scholars in the field of traditional medicine , doctors , chem - Research Conducting within Forested Areas ( ï쳌² ï쳌¦ ï쳌³ ï쳌² ï쳌£ ï쳌¦ ï쳌¡ ) ists , and government officials . Stakeholders discussed go back to ï?? ï?? ï?? ï?? when the working group on genetic re - different ideas and strategies to ensure the protection of sources ( established under the National Committee on the Convention on Biological Diversity ) examined legal issues medicinal knowledge about plants and animals . The debate ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ also addressed Article ï?? ( j ) of the ï쳌£ ï쳌¢ ï쳌¤ on the protection and rights , and capacity building . Priority has also been given to the discussion of the protection of traditional of traditional knowledge , innovations , and practices . The knowledge and innovation and the fair and equitable draft went through several public hearings , it was sent to sharing of benefits derived from biodiversity . Parliament , and became law in ï?? ï?? ï?? ï?? ( J . Donavanik , pers . Regional and international organizations such as ï쳌³ ï쳌° ï쳌² ï쳌¥ ï쳌° , comm . January ï?? ï?? ï?? ï?? ) . ï쳌· ï쳌· ï쳌¦ - ï쳌³ ï쳌° ï쳌° , and ï쳌¦ ï쳌© ï쳌¥ ï쳌¬ ï쳌¤ have supported these initiatives with Concerns regional and national workshops held in Fiji andVanuatu in The development process of the ï쳌° ï쳌¶ ï쳌° ï쳌¡ was marked by March ï?? ï?? ï?? ï?? and April ï?? ï?? ï?? ï?? , respectively . The workshops rivalry between domestic ï쳌® ï쳌§ ï쳌¯ s and government officials . have provided a valuable arena for stakeholders to discuss Ownership of genetic resources , indigenous knowledge , a great variety of issues ranging from ownership of biologi - and ï쳌© ï쳌° ï쳌² s were controversial issues . For example , ï쳌® ï쳌§ ï쳌¯ s cal and genetic resources to definitions of access to genetic did not want modern ï쳌© ï쳌° ï쳌² protection such as patents on life resources . Discussions among stakeholders still continue forms or traditional knowledge . The private sector stressed but access and benefit - sharing regulations are expected to the potential of genetic resources as a source of monetary be incorporated into a draft Environment Act that should and nonmonetary benefits to society . Compromise re - be introduced into Parliament in ï?? ï?? ï?? ï?? ( C . Schuster , pers . garding this point was reached by providing a minimum comm . August ï?? ï?? ï?? ï?? ) . standard of protection to allow the protection of inventions Concerns ( J . Donavanik , pers . comm . January ï?? ï?? ï?? ï?? ) . In the absence of national regulations , government agen - The development process of the ï쳌² ï쳌¦ ï쳌³ ï쳌² ï쳌£ ï쳌¦ ï쳌¡ had to over - cies have negotiated ad hoc arrangements with bioprospec - come conflicts about details involving monitoring strate - tors that include a standard application form , not legally gies , application proposals , and progress reports among the binding , that has been used since ï?? ï?? ï?? ï?? to regulate foreign members of the technical committee . ï쳌² ï쳌¦ ï쳌¤ officials where bioprospectors . Kava ( Piper methysticum ) and other bio - also concerned about potential biopiracy and they proposed logical resources have been heavily exploited in Vanuatu prevention strategies such as assigning a co - researcher to and there is a perception that local communities have not every bioprospecting project . Some officials who were been adequately compensated for their resources and tradi - concerned about biopiracy issues also attempted to put tional knowledge . Local researchers and institutions have additional restrictions in the access process . not been invited to collaborate in bioprospecting initiatives In the early stages of the development process of the and the government does not monitor the use of samples ï쳌¡ ï쳌° ï쳌° ï쳌´ ï쳌­ ï쳌© , the government was not open to the idea of this act once they leave the country . In addition , there are concerns because its scope had not been clearly defined ( see Chapter that samples initially collected for one purpose are stored ï?? ) . Furthermore , there were concerns about compatibility and then used for another purpose . For example , blood issues between the act and ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ . These concerns were samples originally collected for malaria experiments were echoed by the American Embassy in Thailand . However , later used for the human genome project . The unauthorized the scope was refined , compatibility issues were addressed , use of blood samples resulted in protests from indigenous the government accepted the draft bill , and it was passed groups ( C . Schuster , pers . comm . October ï?? ï?? ï?? ï?? ) . into law ( J . Donavanik , pers . comm . January ï?? ï?? ï?? ï?? ) . Ownership of land and genetic resources is a complex issue . According to the constitution , traditional communi - Vanuatu ties own all the land in Vanuatu . Therefore , ï쳌° ï쳌© ï쳌£ procedures Process are particularly important , but researchers have shown re - In ï?? ï?? ï?? ï?? , the Ministry of Lands , Natural Resources , Energy , sistance to follow them . Land cannot be alienated but the and Environment established a National Biodiversity government may own land acquired by it in the public Advisory Committee that promoted a process of discussion interest . Parliament , after consultation with the national of biodiversity issues to facilitate the implementation of Council of Chiefs , may allocate land according to different the ï쳌£ ï쳌¢ ï쳌¤ . This committee had ample participation by repre - use categories . Lack of financial aid , technical informa - sentatives of government , academic institutions , and ï쳌® ï쳌§ ï쳌¯ s tion , and expertise are also major concerns in Vanuatu . that , together with the Ministry , facilitated the completion Efforts to complete the National Biodiversity Strategy and of the National Biodiversity Action Plan in ï?? ï?? ï?? ï?? . In ï?? ï?? ï?? ï?? , Action Plan would have not been possible without funds the momentum created by this plan was channeled by the from the ï쳌§ ï쳌¥ ï쳌¦ and technical assistance from organizations Ministry to establish four working groups to have discus - such as ï쳌³ ï쳌° ï쳌² ï쳌¥ ï쳌° and ï쳌· ï쳌· ï쳌¦ - ï쳌³ ï쳌° ï쳌° ( C . Schuster , pers . comm . sions on access and benefit sharing , traditional knowledge October ï?? ï?? ï?? ï?? ) . ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : S ï쳌£ ï쳌¥ ï쳌® ï쳌¡ ï쳌² ï쳌© ï쳌¯ ï쳌³ ï쳌¯ ï쳌¦ P ï쳌¯ ï쳌¬ ï쳌© ï쳌£ ï쳌¹ ï쳌­ ï쳌¡ ï쳌« ï쳌© ï쳌® ï쳌§ P ï쳌² ï쳌¯ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ Policymaking Process : Analysis For the countries reviewed in this chapter , ï쳌¡ ï쳌¢ ï쳌³ policymak - and sustainable use of biological diversity and the equi - table distribution of benefits derived from this diversity , ing has been an incremental process , a sequence of events among other issues . Many countries , however , have been influenced by many actors with different interests , values , unable to address several ï쳌£ ï쳌¢ ï쳌¤ issues comprehensively and information roles , perspectives , and agendas . Since the ï쳌£ ï쳌¢ ï쳌¤ effectively . ï쳌¡ ï쳌¢ ï쳌³ , for example , has not been a priority for came into force , each nation has followed different policy ï?? ï?? % of the Pacific Rim countries examined in this report . timelines driven by its unique social , economic , and politi - Lack of technical expertise , budgetary constraints , weak cal circumstances . While a few countries have concluded government structures and political support , local social the policymaking process , most are still conducting it , and conflict , and conflict over ownership of biological resourc - some have not yet found the conditions to initiate it . es are some of the reasons cited by ï쳌¡ ï쳌¢ ï쳌³ experts that have The policymaking process can be visualized in many prevented Kiribati , Lao Peopleâ??s Democratic Republic , ways . B ï쳌² ï쳌¥ ï쳌· ï쳌¥ ï쳌² and ï쳌¤ ï쳌¥ L ï쳌¥ ï쳌¯ ï쳌® ( ï?? ï?? ï?? ï?? ) propose that a frame - Nauru , Palau , Tonga , and Tuvalu from working actively work composed of three stages : a ) initiation , b ) estimation , towards the development of ï쳌¡ ï쳌¢ ï쳌³ policies . The remaining and c ) selection can be used to characterize policymak - ï?? ï?? % of Pacific Rim countries have managed at least to ing efforts . Initiation consists of problem identification initiate policy processes to incorporate ï쳌¡ ï쳌¢ ï쳌³ provisions and agenda setting , estimation involves expert analysis into national laws and policies ( see Table ï?? of Chapter and technical consideration , and selection refers to the ï?? ) . They have allocated scarce financial and technical re - fact that someone , based on technical and political input , sources needed to begin the collection of key information has to make a decision about the best course of action or and the identification of the range of possible responses , policy . This framework facilitates the identification and policy choices , and stakeholders . understanding of key patterns and lessons from our case The controversial nature of ï쳌¡ ï쳌¢ ï쳌³ issues demand the in - studies . volvement of potential providers , users , and intermediaries of genetic resources in the initiation process of ï쳌¡ ï쳌¢ ï쳌³ policies . Policy Initiation If these stakeholders appropriate the policy development ï쳌¡ ï쳌¢ ï쳌³ issues have been poorly defined by the ï쳌£ ï쳌¢ ï쳌¤ . Most of process as their own , this will increase the legitimacy of the the work has been passed to the member countries that have policy outcome and facilitate its implementation process . received key input from the ï쳌£ ï쳌¢ ï쳌¤ secretariat , Conference Government agencies , legislative commissions , industry of the Parties , and other bodies . As ï쳌£ ï쳌¢ ï쳌¤ members , coun - and academic groups , ï쳌® ï쳌§ ï쳌¯ s , and regional economic and tries have responsibilities that include identifying relevant social integration organizations have been some of the loci ï쳌¡ ï쳌¢ ï쳌³ issues , putting them on the agenda , identifying the for initiation of processes for countries that have completed stakeholders , ensuring equal opportunities to participate , or are currently working on ï쳌¡ ï쳌¢ ï쳌³ policies . Industry groups , initiating the debate , and addressing policy and value ï쳌® ï쳌§ ï쳌¯ s , and academia played varying roles in the initiation conflicts . process of pioneer ï쳌¡ ï쳌¢ ï쳌³ laws such as the Andean Decision The agenda of the policymaking process can be divided ï?? ï?? ï?? , the Philippinesâ??s ï쳌¥ ï쳌¯ ï?? ï?? ï?? , and Costa Ricaâ??s Law of into systemic and institutional ( B ï쳌µ ï쳌£ ï쳌« ï?? ï?? ï?? ï?? ) . The systemic Biodiversity . The process that resulted in the adoption of agenda includes all issues that the â?? attentive public â?쳌 agrees Decision ï?? ï?? ï?? by the Andean Community was initiated by need to be resolved . The â?? attentive public â?쳌 is the informed , the Secretariat of the Andean Community with technical political , intellectual , and more educated layer of society . support from domestic ï쳌® ï쳌§ ï쳌¯ s , international agriculture This public is usually composed of representatives of research centers , and government agencies . At the initial academic , research , advocate , or grassroots organizations . stage of the policy debate these actors attempted to de - They are vocal about recurring issues that are problematic mocratize the process by holding a workshop but conflict and cannot be ignored . When this public can convince its and controversy arose among participants and thwarted government about the importance of these issues , then the continuation of the participatory process . Some ï쳌® ï쳌§ ï쳌¯ s , policymakers place these issues on the institutional agenda . for example , advocated a policy instrument focused on Sometimes , however , issues bypass the systemic agenda biodiversity conservation and sustainable use goals , while and simply originate at the institutional level . The institu - government actors insisted on the importance of keep - tional agenda includes issues that the government plans ing the commercial perspective of ï쳌¡ ï쳌¢ ï쳌³ issues . No middle to consider seriously and actively . The problem is clearly ground was found and government officials assimilated identified , solutions are proposed , and financial resources the policymaking process that resulted in the commercial are allocated . Issues placed on the institutional agenda are orientation of Decision ï?? ï?? ï?? . This outcome suggested that also subject to time constraints the concern of government agencies had the tendency to When the ï쳌£ ï쳌¢ ï쳌¤ came into force , ï쳌¡ ï쳌¢ ï쳌³ issues were placed dominate the process conceptually and administratively on the institutional agenda of the international community to the exclusion of concerns of some environmental ï쳌® ï쳌§ ï쳌¯ s of countries . More than ï?? ï?? ï?? countries agreed on the need and other participants that should have shared the focus to implement the ï쳌£ ï쳌¢ ï쳌¤ in order to ensure the conservation of attention . Years after the adoption of Decision ï?? ï?? ï?? ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ and criticism about its restrictive nature ( G ï쳌² ï쳌¡ ï쳌ª ï쳌¡ ï쳌¬ ï?? ï?? ï?? ï?? ) , a multi - departmental government agency , responsible for Andean countries such as Colombia are still working on coordinating nonregulatory biotechnology issues for the national policies to facilitate its implementation . Commonwealth Government ( see Chapter ï?? ) . A differ - In the Philippines , an academic / industry group initi - ent but equally effective process to develop a federal ï쳌¡ ï쳌¢ ï쳌³ ated the policy process that resulted in the adoption of policy was initiated by a task force integrating federal ï쳌¥ ï쳌¯ ï?? ï?? ï?? . In spite of the participatory process launched and state representatives from government and ï쳌® ï쳌§ ï쳌¯ s of by this group , involving and making government and Malaysia . The sufficiently diverse composition of the task other sectors support the process was a difficult and long force provided technical expertise and legitimacy to the undertaking . Similarly , the first draft of Costa Ricaâ??s process . Government and nongovernment agencies with Law of Biodiversity was developed by a Costa Rican ex - strong technical capacities on biotechnology and biodi - politician with technical support provided by the World versity research together with environment ministries Conservation Unionâ??s Regional Office for Mesoamerica . have proven to be an effective combination to advance The process included the participation of a wide variety of the incorporation of ï쳌¡ ï쳌¢ ï쳌³ goals into national policies . This sectors , but interestingly enough the Costa Rican Ministry pattern is clear not only inAustralia and Malaysia , but also of the Environment and Energy was not deeply involved in Costa Rica and the Philippines . into the process and no one within the Ministry appropri - ï쳌³ ï쳌° ï쳌² ï쳌¥ ï쳌° , ï쳌· ï쳌· ï쳌¦ - ï쳌³ ï쳌° ï쳌° , and ï쳌¦ ï쳌© ï쳌¥ ï쳌¬ ï쳌¤ have held a series of work - ated the new law as a government initiative ( J . Cabrera , shops among Pacific Island countries that initiated ï쳌¡ ï쳌¢ ï쳌³ pro - pers . comm . February ï?? ï?? ï?? ï?? ) . Therefore , when the new cesses in countries such as Cook Islands , Marshall Islands , Minister came into power , she submitted a constitutional Niue , Samoa , and Vanuatu . A direct impact of a workshop challenge that has prevented the full implementation of held in Fiji was Samoaâ??s adoption of ï쳌¡ ï쳌¢ ï쳌³ conditions as the law . Costa Ricaâ??s Law of Biodiversity has influenced an executive provisional measure to regulate ï쳌¡ ï쳌¢ ï쳌³ goals . other Central American nations such as Nicaragua . In this These conditions have been turned into a bioprospecting case , however , Nicaraguaâ??s Ministry for the Environment regulation that will complement an upcoming Land and and Natural Resources provided leadership to initiate and Environment Act ( see Chapter ï?? ) . Other countries such advance a participatory development process of a draft as Cambodia , China , El Salvador , Honduras , Indonesia , Law of Biodiversity that addresses ï쳌¡ ï쳌¢ ï쳌³ issues and other Japan , New Zealand , Papua New Guinea , the Republic of biodiversity related goals . Presently , however , the draft Korea , the Russian Federation , Singapore , and Thailand law is stalled because the Agriculture Ministry argues have different processes under way that have been initi - that biosafety issues fall under the jurisdiction of this ated by central government bodies in charge of judicial body , hence an independent law enforced by the Ministry and environmental duties ( see Table ï?? of Chapter ï?? ) . should address them . This brings up the point that ï쳌¡ ï쳌¢ ï쳌³ All of them are still at initial or intermediate stages of policy goals are typically under the jurisdiction of multiple discussing ï쳌¡ ï쳌¢ ï쳌³ . government organizations that must be actively involved into the policymaking process . Policy Estimation Processes to include ï쳌¡ ï쳌¢ ï쳌³ principles into existing laws Policy initiation and estimation are usually parallel pro - have also been initiated by governmental bodies with vary - cesses ( B ï쳌² ï쳌¥ ï쳌· ï쳌¥ ï쳌² and ï쳌¤ ï쳌¥ L ï쳌¥ ï쳌¯ ï쳌® ï?? ï?? ï?? ï?? ) . Estimation is essen - ing degrees of success . For example , Mexicoâ??s ï쳌³ ï쳌¥ ï쳌­ ï쳌¡ ï쳌² - tial not only to analyze risks , costs , and benefits of ï쳌¡ ï쳌¢ ï쳌³ ï쳌® ï쳌¡ ï쳌´ and the commissions on ecology and environment goals but also to facilitate the selection of the ï쳌¡ ï쳌¢ ï쳌³ policy promoted the reform of ï쳌¥ ï쳌¥ ï쳌¥ ï쳌° ï쳌§ ï쳌¡ . The reform , however , ( Law of Biodiversity , stand - alone national ï쳌¡ ï쳌¢ ï쳌³ policy , was not significant and only two articles ( ï?? ï?? and ï?? ï?? ï쳌¢ ï쳌© ï쳌³ ) etc . ) that fits legal , social , administrative , economic , and were included into the Act to facilitate access and ben - political conditions of the country . Estimation also involves efit - sharing goals . Legal gaps and a lack of a nationwide the analysis of empirical and theoretical characteristics participatory process during the development of the law of ï쳌¡ ï쳌¢ ï쳌³ issues that apply to ï쳌° ï쳌© ï쳌£ , biodiversity conservation , questioned its legitimacy ( see Chapter ï?? ) . Thailandâ??s ownership of genetic resources , and the protection of ï쳌² ï쳌¦ ï쳌³ ï쳌² ï쳌£ ï쳌¦ ï쳌¡ , was developed by ï쳌² ï쳌¦ ï쳌¤ officials without input traditional knowledge ( see Chapter ï?? ) . Sometimes these from other stakeholders . So far the regulation has not been policy goals are in conflict with each other and with ex - tested by commercial bioprospectors . Similarly , Chileâ??s isting policies and forms of government . An example of Ministry of Agriculture completed in isolation a draft for this is the incompatibility between Chileâ??s current strict a law to regulate access to agricultural genetic resources private property right system and the issue of ownership that was discarded after severe criticism ( see Chapter ï?? ï?? ) . of genetic resources which prevented initial efforts to de - In contrast , the process initiated by Environment Australia velop an ï쳌¡ ï쳌¢ ï쳌³ policy in that country . Malaysiaâ??s initiatives to include ï쳌¡ ï쳌¢ ï쳌³ provisions into the ï쳌¥ ï쳌° ï쳌¢ ï쳌£ ï쳌¡ involved the par - to adopt a national ï쳌¡ ï쳌¢ ï쳌³ policy have also been delayed by ticipation of biotechnology , indigenous , environmental , a property rights conflict . The federal government claims government , and academic groups through a national ownership over genetic resources found in federal land inquiry and several public hearings . A key factor that that are also claimed by state governments and indigenous contributed to the strength and momentum of the process was the establishment in ï?? ï?? ï?? ï?? of BiotechnologyAustralia , communities . Similarly , New Zealandâ??s Maori people have ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : S ï쳌£ ï쳌¥ ï쳌® ï쳌¡ ï쳌² ï쳌© ï쳌¯ ï쳌³ ï쳌¯ ï쳌¦ P ï쳌¯ ï쳌¬ ï쳌© ï쳌£ ï쳌¹ ï쳌­ ï쳌¡ ï쳌« ï쳌© ï쳌® ï쳌§ P ï쳌² ï쳌¯ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ claimed exclusive rights over genetic resources , thereby The Mexican experience also shows that the simplistic delaying efforts to initiate an ï쳌¡ ï쳌¢ ï쳌³ policy ( see Table ï?? of focus of ï쳌¡ ï쳌¢ ï쳌³ policy incorporated into the ï쳌¥ ï쳌¥ ï쳌¥ ï쳌° ï쳌§ ï쳌¡ diverted Chapter ï?? ) . Ownership of genetic resources found in ex attention from the short - and medium - term problems that situ conditions has also been a concern forAustralia , Cook arise with implementation of the policy ( see Chapter ï?? ) . Islands , and Nicaragua . A more comprehensive perspective of ï쳌¡ ï쳌¢ ï쳌³ issues can be Policy estimation also has to take into account politi - addressed within the context of ï쳌® ï쳌¢ ï쳌³ ï쳌¡ ï쳌° , which is the first cal agendas , misperceptions , value conflicts , and different step followed by most countries that want to implement the levels of information and expertise . For example , organi - ï쳌£ ï쳌¢ ï쳌¤ as a whole ( M ï쳌© ï쳌¬ ï쳌¬ ï쳌¥ ï쳌² and L ï쳌¡ ï쳌® ï쳌¡ ï쳌µ ï?? ï?? ï?? ï?? ) . There is not zations such as ï쳌¥ ï쳌´ ï쳌£ ( formerly known as ï쳌² ï쳌¡ ï쳌¦ ï쳌© ) label any sufficient evidence that ï쳌® ï쳌¢ ï쳌³ ï쳌¡ ï쳌° can lead to successful ï쳌¡ ï쳌¢ ï쳌³ kind of bioprospecting ( even if it involves benefit - sharing policies . But Chileâ??s recent National Biodiversity Strategy 8 agreements ) as biopiracy and this message has reached and future ï쳌® ï쳌¢ ï쳌³ ï쳌¡ ï쳌° may provide the needed framework , re - many indigenous and grassroots organizations worldwide . sources , political support , and momentum to overcome Some level of opposition to bioprospecting and concerns old difficulties in developing an ï쳌¡ ï쳌¢ ï쳌³ policy . Countries about the inequitable distribution of benefits was identified such as Australia , Cook Islands , El Salvador , Honduras , in all the countries addressed in this chapter . The protec - Marshall Islands , Micronesia , New Zealand , Niue , Palau , tion of traditional knowledge and patenting of life are also the Russian Federation , and Tonga have also followed this major concerns , particularly in countries such asAustralia , approach . On the other hand , China , Colombia , Ecuador , Ecuador , Honduras , Malaysia , Mexico , Panama , Peru , and Peru , Philippines , and Thailand , among other countries , Thailand that have significant indigenous populations . have developed or are developing ï쳌¡ ï쳌¢ ï쳌³ policies indepen - The essential role of policy experts and facilitators of dently of any process triggered by an ï쳌® ï쳌¢ ï쳌³ ï쳌¡ ï쳌° . explaining the multiple dimensions and implications of Policy options identified in this report that address ï쳌¡ ï쳌¢ ï쳌³ ï쳌¡ ï쳌¢ ï쳌³ policies is certainly needed in all the countries that goals include : are attempting to implement the ï쳌£ ï쳌¢ ï쳌¤ . ï쳌¡ ï쳌¢ ï쳌³ issues have â?¢ Regional and national stand - alone ï쳌¡ ï쳌¢ ï쳌³ laws and presented new conceptual , political , and operational chal - policies ( Andean Community , China , Malaysia , lenges to stakeholders . Technical guidance and support and the Philippines ) ; by the Conference of the Parties of the ï쳌£ ï쳌¢ ï쳌¤ , the ad hoc â?¢ Laws of biodiversity , sustainable development , group of experts on ï쳌¡ ï쳌¢ ï쳌³ , and regional organizations such or environment acts that include biodiversity con - as ï쳌³ ï쳌° ï쳌² ï쳌¥ ï쳌° have been instrumental to further key national servation and sustainable use provisions and ï쳌¡ ï쳌¢ ï쳌³ efforts . Countries such as Panama and Indonesia have guidelines . These laws are usually designed to welcomed and are using the Bonn Guidelines on ï쳌¡ ï쳌¢ ï쳌³ . implement the ï쳌£ ï쳌¢ ï쳌¤ as a whole ( Costa Rica , Cook ï쳌³ ï쳌° ï쳌² ï쳌¥ ï쳌° workshops and technical assistance together with Islands , Honduras , Indonesia , and Nicaragua ) ; technical expertise provided by ï쳌¦ ï쳌© ï쳌¥ ï쳌¬ ï쳌¤ , ï쳌· ï쳌· ï쳌¦ - South Pacific â?¢ Existing environmental , sustainable development Programme , and the United Nations University have sup - or ecological laws that have been amended ( by ported ï쳌¡ ï쳌¢ ï쳌³ initiatives of Pacific Island countries . Efforts national legislative bodies ) or modified ( through advanced by these organizations , however , do not have an executive regulations ) to include ï쳌¡ ï쳌¢ ï쳌³ provisions impact unless they are assimilated and appropriated by ( Australia and Mexico ) ; strong and proactive national agencies and ï쳌® ï쳌§ ï쳌¯ s . Building local capacity to improve policy initiation and estimation â?¢ ï쳌¡ ï쳌¢ ï쳌³ policies that may be developed further into is a priority for all the countries reviewed in this chapter more comprehensive ï쳌¡ ï쳌¢ ï쳌³ laws ( El Salvador , Samoa , but particularly so for the Pacific Island countries . and Panama ) . It is not realistic to suggest that any one of the above Policy Selection policy approaches is a magic wand that can facilitate the incorporation of ï쳌¡ ï쳌¢ ï쳌³ principles into national policies . Each Selection involves the most political step in the policymak - of them has advantages and disadvantages . For example , ing process . A decision maker or decision makers select a the Costa Rican experience shows that the debate of a course of action based on available technical , social , and multi - objective regulation such as the Law of Biodiversity political information gathered and analyzed during the may not provide the time or resources to debate adequately initiation and estimation stages ( B ï쳌² ï쳌¥ ï쳌· ï쳌¥ ï쳌² and ï쳌¤ ï쳌¥ L ï쳌¥ ï쳌¯ ï쳌® the intricacies of ï쳌¡ ï쳌¢ ï쳌³ issues . Also , Nicaraguaâ??s draft Law ï?? ï?? ï?? ï?? ) . If previous analyses present technical contradic - of Biodiversity overlaps with existing laws and presents tions or political conflicts , policymakers may decide not to a jurisdictional conflict to government agencies . Policy select any policy . For example , in the early ï?? ï?? ï?? ï?? s , Chileâ??s approaches should be carefully analyzed and selected National Commission of the Environment examined the according to national social , political , and institutional possibility of developing a national ï쳌¡ ï쳌¢ ï쳌³ law , but this effort characteristics , priorities , and local expertise . was thwarted by an inability to resolve technical issues , In some countries that share common ecosystems and lack of political support , and the unwillingness of govern - cultural backgrounds , national ï쳌¡ ï쳌¢ ï쳌³ policies have been sup - ment officials to promote a participatory process to discuss the issue ( see Chapter ï?? ï?? ) . ported by regional initiatives such as the CentralAmerican ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ Protocol onAccess to Genetic and Biochemical Resources bioprospectors from shopping for the best deal in coun - and theirAssociated Knowledge and the ï쳌¡ ï쳌³ ï쳌¥ ï쳌¡ ï쳌® framework tries that share similar ecosystems . All Central American agreement on access to biological and genetic resources . countries already signed the Protocol and when approved One of the goals of these regional frameworks is to ensure it will become national law in each of them . The ï쳌¡ ï쳌³ ï쳌¥ ï쳌¡ ï쳌® that national ï쳌¡ ï쳌¢ ï쳌³ requirements are consistent to prevent framework is expected to be adopted in ï?? ï?? ï?? ï?? or ï?? ï?? ï?? ï?? . Final Comment Ideally , the policy process has to be initiated and ap - problems and concerns ( this chapter ) , and in the opportu - propriated by the highest number possible of providers , nity to involve key stakeholders that bring legitimacy to users , and intermediaries of genetic resources to ensure the policy process , its final outcome , and implementation its legitimacy during its development and implementation . process . This is certainly a long , difficult , and expensive This is the main lesson identified from ï쳌¡ ï쳌¢ ï쳌³ policy processes process and there are no guarantees about the efficacy and carried out in countries that include Colombia , Costa Rica , efficiency of the policy outcome . However , our case studies Mexico , the Philippines , Australia , and Malaysia ( see suggest that ï쳌¡ ï쳌¢ ï쳌³ polices that reflect and involve the needs Chapters ï?? , ï?? , ï?? , ï?? , ï?? , and ï?? ï?? ) . The advantages of carry - and desires of all stakeholders have a higher probability ing out a wide participatory process lie in the collection of being successful than those that are developed by a of key practical and theoretical information about ï쳌¡ ï쳌¢ ï쳌³ minority of technocrats . issues ( see Chapter ï?? ) , in the identification of potential References A ï쳌® ï쳌¤ ï쳌¥ ï쳌¡ ï쳌® C ï쳌¯ ï쳌­ ï쳌­ ï쳌µ ï쳌® ï쳌© ï쳌´ ï쳌¹ . ï?? ï?? ï?? ï?? . Decision ï?? ï?? ï?? : Regional biodi - G ï쳌² ï쳌¡ ï쳌ª ï쳌¡ ï쳌¬ A . ï?? ï?? ï?? ï?? . Biodiversity and the nation state : Regulating versity strategy for the tropical Andean countries . ï쳌µ ï쳌² ï쳌¬ : access to genetic resources limits biodiversity research in http : / / www.comunidadandina.org / ingles / treaties / dec / developing countries . Conservation Biology ï?? ï?? ( ï?? ) : ï?? â?? ï?? . D ï?? ï?? ï?? e.htm . L ï쳌¡ A ï쳌³ ï쳌¡ ï쳌­ ï쳌¢ ï쳌¬ ï쳌¥ ï쳌¡ L ï쳌¥ ï쳌§ ï쳌© ï쳌³ ï쳌¬ ï쳌¡ ï쳌´ ï쳌© ï쳌¶ ï쳌¡ . ï?? ï?? ï?? ï?? . Ley No . ï?? ï?? ( de ï?? de julio B ï쳌² ï쳌¥ ï쳌· ï쳌¥ ï쳌² G.D . and P . ï쳌¤ ï쳌¥ L ï쳌¥ ï쳌¯ ï쳌® . ï?? ï?? ï?? ï?? . The foundations of policy de ï?? ï?? ï?? ï?? ) : Ley general de ambiente de la Republica de analysis . The Dorsey Press , ï쳌© ï쳌¬ ï쳌µ ï쳌³ ï쳌¡ . Panamá . Diario Oficial No . ï?? ï?? , ï?? ï?? ï?? , Panamá . B ï쳌µ ï쳌£ ï쳌« S.J . ï?? ï?? ï?? ï?? . Understanding environmental administration M ï쳌© ï쳌¬ ï쳌¬ ï쳌¥ ï쳌² K.R . and S.M . L ï쳌¡ ï쳌® ï쳌¯ ï쳌µ . ï?? ï?? ï?? ï?? . National biodiversity and law . Island Press , ï쳌£ ï쳌¡ ï쳌µ ï쳌³ ï쳌¡ . planning : Guidelines based on early experiences around ï쳌¦ ï쳌¡ ï쳌¯ . ï?? ï?? ï?? ï?? . The state of the worldâ??s plant genetic resources for the world . World Resources Institute , Washington , ï쳌¤ ï쳌£ ï쳌µ ï쳌³ ï쳌¡ . food and agriculture . Rome , Italy . Endnotes 1 Consistent with my use in Chapter ï?? , I define bioprospecting as j ) the 1998 Provisional Regulation for Human Genetic Resources ; and k ) the 2001 Regulation for Safety of Agricultural Genetically - the search for plants , animals , and microbial species for academic , Modified Organisms ( D . Xue , pers . comm . December 2003 ) . pharmaceutical , biotechnological , agricultural , and other industrial purposes . ï?? â?? One of the oldest regional organizations in the world , ï쳌³ ï쳌° ï쳌£ cel - 2 In March ï?? ï?? ï?? ï?? the Ministry of Agriculture started a process of ebrated its ï?? ï?? th anniversary on ï?? February ï?? ï?? ï?? ï?? . It is a non - politi - consultation and analysis within government agencies to determine cal , technical assistance and research body , and fills a consultative the consequences and benefits that signature and ratification of the and advisory role . â?쳌 ï쳌µ ï쳌² ï쳌¬ : http : / / www.spc.org.nc / history.htm . ï쳌© ï쳌´ ï쳌° ï쳌§ ï쳌² ï쳌¦ ï쳌¡ may have for Chile . After a few months of discussions ï?? While the above process was taking place at the federal level , the Chile signed it on ï?? November ï?? ï?? ï?? ï?? ( see Chapter ï?? ï?? ) . states of Sarawak and Sabah were working on their own access and 3 See the ï쳌¦ ï쳌© ï쳌¥ ï쳌¬ ï쳌¤ website at ï쳌µ ï쳌² ï쳌¬ : http : / / www.field.org.uk / biodiversity_ benefit - sharing regulations that culminated in the enactment of the pg ï?? . php . Sarawak Biodiversity Center Ordinance of ï?? ï?? ï?? ï?? and the Sabah 4 These policies and laws are : a ) the 1989 Wild Animal Protection Biodiversity Enactment of ï?? ï?? ï?? ï?? ( see Chapter ï?? ï?? ) . Law ; b ) the 1997 Wild Plant Protection Regulation ; c ) the 1998 7 Regulation for Protection of New Plant Varieties ; d ) the 1989 This preliminary draft was developed with technical support Regulation for Seeds Administration ; e ) the 2000 Seeds Law ; f ) the provided by the New Zealand Official Development Assistance 1993 Regulation for Protection of Chinese Herb Medicine Varieties ; ( known today as the New Zealand Agency for International g ) the 1994 Administrative Regulation for Breeding Livestock , Development ) . Animals , and Poultry ; h ) the 1994 Regulation for Nature Reserves ; 8 i ) the Provisional Regulation for Seeds Importing and Exporting ; See http : / / www.etcgroup.org / article.asp ? newsid = ï?? ï?? ï?? . ï?? ï?? 3 Implementation Pathways Stephen B . Brush and Santiago Carrizosa The drafting and implementation of national policies and genetic resources and traditional knowledge , and c ) initia - laws to facilitate access to genetic resources and ensure the tion of approved projects for the collection of biological equitable sharing of the benefits of access is still very much materials and the return of benefits related to collecting . It a work in progress . Only ï?? ï?? % of Pacific Rim countries is impossible at this time to determine whether the imple - have established access and benefit - sharing ( ï쳌¡ ï쳌¢ ï쳌³ ) laws and mentation of ï쳌¡ ï쳌¢ ï쳌³ policies has been successful in meeting policies ( see Chapter ï?? ) and their experience in implement - the overarching goals of the ï쳌£ ï쳌¢ ï쳌¤ beyond providing access ing them is uneven . Costa Rica , the Philippines , Mexico , to biological resources ( i.e . , providing benefit sharing and 1 Samoa , and the ï쳌µ ï쳌³ ï쳌¡ ( National Park Service ( ï쳌® ï쳌° ï쳌³ ) policy ) achieving conservation of biological diversity ) . Our evalu - are the only Pacific Rim countries that have approved ac - ation of the extent to which these goals have been met is cess applications under ï쳌¡ ï쳌¢ ï쳌³ laws and policies developed limited by the following considerations : a ) many projects or reformed after the Convention on Biological Diversity which have been initiated under ï쳌¡ ï쳌¢ ï쳌³ regimes are still in ( ï쳌£ ï쳌¢ ï쳌¤ ) came into force in ï?? ï?? ï?? ï?? ( see Table ï?? of Chapter ï?? ) . progress , b ) a delay is expected in identifying , using , and The novel and sometimes experimental nature of some perhaps commercializing useful genetic resources , and c ) of the policy tools employed affects our ability to distill a long time is needed to determine whether biodiversity definitive lessons or guidelines that can be used to im - conservation and adequate benefit sharing have indeed prove existing or pending ï쳌¡ ï쳌¢ ï쳌³ frameworks . Nevertheless , been achieved . the range of experiences among Pacific Rim countries in 2 processing bioprospecting project proposals is useful in The Road Towards Implementation of ABS anticipating obstacles and suggesting pathways to policy Laws and Policies implementation . Under the ï쳌¡ ï쳌¢ ï쳌³ laws and policies of these 3 The ï쳌£ ï쳌¢ ï쳌¤ and biopiracy claims prompted governments countries a total of ï?? ï?? bioprospecting projects have been around the world to draft national ï쳌¡ ï쳌¢ ï쳌³ policies . Because the approved between ï?? ï?? ï?? ï?? and July ï?? ï?? ï?? ï?? ( see Table ï?? ) . The ï쳌£ ï쳌¢ ï쳌¤ recognized that countries have sovereign rights over purpose of this chapter is to use the information gathered their genetic resources , it did not specify or suggest model in the Pacific Rim case studies ( Chapters ï?? through ï?? ) to 4 policies for nations to emulate , but a few noteworthy ex - illustrate some critical lessons about the implementation periments in fashioning ï쳌¡ ï쳌¢ ï쳌³ agreements have provided of ï쳌¡ ï쳌¢ ï쳌³ regimes . ideas for national policy frameworks . Parties from several We will analyze the implementation of ï쳌¡ ï쳌¢ ï쳌³ policy countries that lack ï쳌¡ ï쳌¢ ï쳌³ frameworks have used Letters of by focusing on three steps in the process of initiating a Intent ( ï쳌¬ ï쳌© ) , Letters of Collection ( ï쳌¬ ï쳌£ ) , Memoranda of bioprospecting project : a ) application to a competent au - Understanding ( ï쳌­ ï쳌¯ ï쳌µ ) , and benefit - sharing or material thority , b ) review and negotiation of acceptable terms such transfer agreements to facilitate access and define benefit - as prior informed consent ( ï쳌° ï쳌© ï쳌£ ) procedures and benefit - sharing obligations with the government and providers of sharing obligations ( see Table ï?? ) . Since the late ï?? ï?? ï?? ï?? s , in ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ response to the reluctance of biodiversity - rich countries fully into the implementation stage of their national ï쳌¡ ï쳌¢ ï쳌³ laws and policies , in terms of processing applications for to allow bioprospectors to conduct collections freely , the biological collections , reviewing and negotiating the terms National Cancer Institute ( ï쳌® ï쳌£ ï쳌© ) in the United States of of access and benefit sharing , and carrying out bioprospect - America ( ï쳌µ ï쳌³ ï쳌¡ ) developed three standard agreements to ing activities . Second , the experience of countries that have facilitate the sharing of monetary and nonmonetary ben - implemented bioprospecting projects is very uneven and efits . The first agreement , a ï?? ï?? ï?? ï?? ï쳌¬ ï쳌© , was later improved information on countries â?? experience is difficult to find . by a ï?? ï?? ï?? ï?? ï쳌¬ ï쳌£ and a ï?? ï?? ï?? ï?? ï쳌­ ï쳌¯ ï쳌µ . Under these instruments At one extreme , some countries have succeeded in launch - ï쳌® ï쳌£ ï쳌© collectors ( e.g . , the New York Botanical Garden , the ing bioprospecting projects after negotiating with parties Missouri Botanical Garden , the University of Illinois at wishing to collect and use biological resources , while at Chicago , and the Coral Reef Research Foundation ) were the other extreme , some countries have failed , with the able to get access to biological samples found in many result that neither access nor benefit sharing has occurred . Pacific Rim countries ( see Table ï?? , C ï쳌² ï쳌¡ ï쳌§ ï쳌§ et al . ï?? ï?? ï?? ï?? , In this chapter , we will illustrate three types of experience ten Kate and Laird ï?? ï?? ï?? ï?? ) . Many of these samples were in implementing ï쳌¡ ï쳌¢ ï쳌³ laws and policies as characterized obtained in collaboration with scientists from local re - by experiences in launching bioprospecting projects un - search and academic organizations . Perhaps the primary der them : successful implementation , mixed success and example of a comprehensive and influential benefit - sharing breakdown , and thwarted implementation . agreement was the Merck â?? National Biodiversity Institute ( ï쳌© ï쳌® ï쳌¢ io ) contract negotiated in Costa Rica in ï?? ï?? ï?? ï?? ( R ï쳌¥ ï쳌© ï쳌¤ Successful Implementation et al . ï?? ï?? ï?? ï?? ) . This agreement not only inspired subsequent Two rather different countries , Costa Rica and the ï쳌µ ï쳌³ ï쳌¡ contracts signed by ï쳌© ï쳌® ï쳌¢ io with many organizations world - have succeeded in signing and entering into bioprospect - wide ( see Chapter ï?? ) , but also the agreements established ing agreements . It is interesting and important to note the under the International Cooperative Biodiversity Group initiation of projects in these countries is not an instance 5 ( ï쳌© ï쳌£ ï쳌¢ ï쳌§ ) program . From ï?? ï?? ï?? ï?? to ï?? ï?? ï?? ï?? , the ï쳌© ï쳌£ ï쳌¢ ï쳌§ s used of implementing ï쳌¡ ï쳌¢ ï쳌³ policies that were formally developed benefit - sharing agreements that facilitated access to the as a government response to the ï쳌£ ï쳌¢ ï쳌¤ . Rather , these projects genetic resources of the following Pacific Rim countries : grew out of personal networks and collaboration between Chile ( ï?? ï?? ï?? ï?? ) , Costa Rica ( ï?? ï?? ï?? ï?? ) , Mexico ( ï?? ï?? ï?? ï?? and ï?? ï?? ï?? ï?? ) , researchers , government officials , and private firms and Panama ( ï?? ï?? ï?? ï?? ) , Peru ( ï?? ï?? ï?? ï?? ) , Laos ( ï?? ï?? ï?? ï?? ) , and Vietnam preceded the ï쳌£ ï쳌¢ ï쳌¤ or emerged outside of its framework . ( ï?? ï?? ï?? ï?? ) ( see Table ï?? ) . Costa Rica . Success in initiating bioprospecting projects The timing and publicity of the ï?? ï?? ï?? ï?? Merck â?? ï쳌© ï쳌® ï쳌¢ io and preceded the creation of a legal framework governing ï쳌© ï쳌£ ï쳌¢ ï쳌§ agreements helped make them models for creating biodiversity ( the ï?? ï?? ï?? ï?? Law of Biodiversity No . ï?? ï?? ï?? ï?? ) in national policies and laws to reach the general goals of response to the ï쳌£ ï쳌¢ ï쳌¤ mandate . The Law of Biodiversity the ï쳌£ ï쳌¢ ï쳌¤ ( R ï쳌¯ ï쳌³ ï쳌¥ ï쳌® ï쳌´ ï쳌¨ ï쳌¡ ï쳌¬ et al . ï?? ï?? ï?? ï?? ) . Among the elements created a national framework that includes the National of these agreements that are replicated in ï쳌¡ ï쳌¢ ï쳌³ policies are Commission of the Management of Biodiversity ( ï쳌£ ï쳌¯ ï쳌® ï쳌¡ ï쳌§ ï쳌¥ - a bilateral and contractual approach , well - defined parties ï쳌¢ ï쳌© ï쳌¯ ) . ï쳌£ ï쳌¯ ï쳌® ï쳌¡ ï쳌§ ï쳌¥ ï쳌¢ ï쳌© ï쳌¯ â?? s role includes the formulation of ï쳌¡ ï쳌¢ ï쳌³ to the contract , exchange of tangible short - and long - term policies . For example , ï쳌£ ï쳌¯ ï쳌® ï쳌¡ ï쳌§ ï쳌¥ ï쳌¢ ï쳌© ï쳌¯ developed a General benefits for the right to access , biodiversity conservation Access Procedure that was approved through an executive and sustainable use , and an intellectual property framework decree in December ï?? ï?? ï?? ï?? ( see Chapter ï?? ) . for deriving benefits ( R ï쳌¥ ï쳌© ï쳌¤ et al . ï?? ï?? ï?? ï?? , R ï쳌¯ ï쳌³ ï쳌¥ ï쳌® ï쳌´ ï쳌¨ ï쳌¡ ï쳌¬ et al . The initial agreement that triggered subsequent ones ï?? ï?? ï?? ï?? ) . These elements are found in many ï쳌¡ ï쳌¢ ï쳌³ policies ( see is the Merck â?? ï쳌© ï쳌® ï쳌¢ io agreement reached in ï?? ï?? ï?? ï?? ( R ï쳌¥ ï쳌© ï쳌¤ et Chapter ï?? ) , but in some contexts , they are associated with al . ï?? ï?? ï?? ï?? ) . ï쳌© ï쳌® ï쳌¢ io grew out of Costa Ricaâ??s unique environ - difficulties in the implementation phase . mental , social , scientific , and political context . Scientific While much of the period following the ï?? ï?? ï?? ï?? United leadership in Costa Rica and the networks between this Nations Conference on the Environment and Development leadership and scientists outside of Costa Rica also were that gave rise to the ï쳌£ ï쳌¢ ï쳌¤ has been devoted to creating poli - instrumental in developing a model ï쳌¡ ï쳌¢ ï쳌³ framework . ï쳌© ï쳌® ï쳌¢ io cies and administrative frameworks for access and benefit was established in ï?? ï?? ï?? ï?? with the support of the Ministry sharing , there is still only a limited number of cases where 6 of Natural Resources , Energy , and Mines ( ï쳌­ ï쳌© ï쳌² ï쳌¥ ï쳌® ï쳌¥ ï쳌­ ) as a national ï쳌¡ ï쳌¢ ï쳌³ law or policy has been tested in terms of part of Costa Ricaâ??s efforts to improve environmental applications , negotiations to establish acceptable terms , protection for its notable biological diversity ( G ï?¡ ï쳌­ ï쳌¥ ï쳌º et and the initiation of activities under agreements for access al . ï?? ï?? ï?? ï?? ) . and benefit sharing . ï쳌© ï쳌® ï쳌¢ ioâ??s novel approach financed conservation through debt - for - nature swaps . ï쳌© ï쳌® ï쳌¢ io grew out of the Biodiversity Case Studies Office , which was a dependency of ï쳌­ ï쳌© ï쳌² ï쳌¥ ï쳌® ï쳌¥ ï쳌­ , but it was Our survey of national laws and policies for access and created as a private , not - for - profit , public - interest associa - benefit sharing relating to biological resources and the tion dedicated to carrying out research and conservation case studies done in the Pacific Rim region illustrate two activities for the protection of biological diversity in Costa general facts . First , relatively few countries have entered Rica . While ï쳌© ï쳌® ï쳌¢ io was created prior to the ï?? ï?? ï?? ï?? Law of ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : I ï쳌­ ï쳌° ï쳌¬ ï쳌¥ ï쳌­ ï쳌¥ ï쳌® ï쳌´ ï쳌¡ ï쳌´ ï쳌© ï쳌¯ ï쳌® P ï쳌¡ ï쳌´ ï쳌¨ ï쳌· ï쳌¡ ï쳌¹ ï쳌³ Wildlife Conservation ( ï쳌¬ ï쳌· ï쳌£ ) No . ï?? ï?? ï?? ï?? , the ï쳌¬ ï쳌· ï쳌£ opened its focus on national parks and designated conservation areas directly connects benefits to accepted conservation a window of opportunity for ï쳌© ï쳌® ï쳌¢ io because an element in activities . Costa Ricaâ??s regulatory framework under the ï쳌¬ ï쳌· ï쳌£ permit - However , and despite the apparent success of this ted ï쳌­ ï쳌© ï쳌² ï쳌¥ ï쳌® ï쳌¥ ï쳌­ to allocate biodiversity prospecting conces - model , Costa Rica went beyond the framework provided sions in national conservation areas ( S ï쳌© ï쳌´ ï쳌´ ï쳌¥ ï쳌® ï쳌¦ ï쳌¥ ï쳌¬ ï쳌¤ and in the ï쳌¬ ï쳌· ï쳌£ by enacting the Law of Biodiversity in ï?? ï?? ï?? ï?? G ï?¡ ï쳌­ ï쳌¥ ï쳌º ï?? ï?? ï?? ï?? ) . ï쳌© ï쳌® ï쳌¢ io became the agent for that allocation ( see Chapter ï?? ) . The new law is a response to the mandate by means of a ï?? ï?? ï?? ï?? formal agreement between ï쳌­ ï쳌© ï쳌² ï쳌¥ ï쳌® ï쳌¥ ï쳌­ of the ï쳌£ ï쳌¢ ï쳌¤ to draft national ï쳌¡ ï쳌¢ ï쳌³ policies , and it replaces and ï쳌© ï쳌® ï쳌¢ io that authorized ï쳌© ï쳌® ï쳌¢ io to negotiate subsequent the nongovernmental approach utilized by ï쳌© ï쳌® ï쳌¢ io with a agreements that provided access to genetic resources in centralized process of issuing access permits through the national parks in return for financial support for ï쳌© ï쳌® ï쳌¢ ioâ??s Technical Office of ï쳌£ ï쳌¯ ï쳌® ï쳌¡ ï쳌§ ï쳌¥ ï쳌¢ ï쳌© ï쳌¯ . ï쳌© ï쳌® ï쳌¢ io is not a member of national biodiversity inventory and the National Parks ï쳌£ ï쳌¯ ï쳌® ï쳌¡ ï쳌§ ï쳌¥ ï쳌¢ ï쳌© ï쳌¯ . Fund of ï쳌­ ï쳌© ï쳌² ï쳌¥ ï쳌® ï쳌¥ ï쳌­ ( S ï쳌© ï쳌´ ï쳌´ ï쳌¥ ï쳌® ï쳌¦ ï쳌¥ ï쳌¬ ï쳌¤ and G ï?¡ ï쳌­ ï쳌¥ ï쳌º ï?? ï?? ï?? ï?? ) . Although the implementation of the Law of Biodiversity The Merck â?? ï쳌© ï쳌® ï쳌¢ io agreement prompted other inter - is not yet fully tested , as Chapter ï?? suggests , it faces some national companies and research institutions to seek severe obstacles . These include lack of clarity about the similar arrangements for access to genetic resources in role and power of key elements in the proposed ï쳌¡ ï쳌¢ ï쳌³ provi - Costa Rica by collaborating with ï쳌© ï쳌® ï쳌¢ io and other national sions , ambiguity about the relation to the ï쳌¡ ï쳌¢ ï쳌³ framework institutions such as the University of Costa Rica . A total established previously under the ï쳌¬ ï쳌· ï쳌£ , and obscurity of ï?? ï?? bioprospecting projects have been granted access and complexity in the application procedures . The gen - to Costa Ricaâ??s biological and genetic resources under eral atmosphere of the new ï쳌¡ ï쳌¢ ï쳌³ regime under the Law of the ï?? ï?? ï?? ï?? î?? î?¶ î?? and its ï?? ï?? ï?? ï?? regulations . The Merck â?? ï쳌© ï쳌® ï쳌¢ io Biodiversity is to be more restrictive and controlling of the agreement was renewed three times before expiring in process of negotiating access and benefits . Furthermore , ï?? ï?? ï?? ï?? . ï쳌© ï쳌® ï쳌¢ io has negotiated ï?? ï?? other agreements with in - the constitutional challenge requested by the Ministry of ternational and national research institutions and private Environment and Energy ( ï쳌­ ï쳌© ï쳌® ï쳌¡ ï쳌¥ , the former ï쳌­ ï쳌© ï쳌² ï쳌¥ ï쳌® ï쳌¥ ï쳌­ , firms for prospecting activities that include chemicals from see endnote ï?? ) in ï?? ï?? ï?? ï?? and made by the Attorney General insects , fragrances and aromas , nematicides , and extremo - against the lawâ??s article that created ï쳌£ ï쳌¯ ï쳌® ï쳌¡ ï쳌§ ï쳌¥ ï쳌¢ ï쳌© ï쳌¯ ( among philic organisms , in addition to bioassays of plants . Nine other articles ) has brought political uncertainty to the role of these agreements are with private firms , one is with a of this commission . The brief record of receiving applica - multilateral organization , three are with universities in the tions under the new law appears to validate these concerns . United Kingdom , ï쳌µ ï쳌³ ï쳌¡ , and Canada , and one is with a local Furthermore , none of the three applications submitted to university and hospital . date have been finalized ( see Chapter ï?? ) . The level of activity reached under the ï쳌¬ ï쳌· ï쳌£ has helped The case of Costa Rica suggests that success in imple - make Costa Rica a model for ï쳌¡ ï쳌¢ ï쳌³ strategies based on bio - mentation of ï쳌¡ ï쳌¢ ï쳌³ policy is best achieved in a decentralized prospecting . The success in carrying out bioprospecting system with flexible norms of negotiating benefits , a simple projects in this framework is due to the special position of and direct system whereby the entity empowered to grant ï쳌© ï쳌® ï쳌¢ io as a nongovernmental institution with high scientific access negotiates directly with the organization seeking and administrative capacity and the ï?? ï?? ï?? ï?? agreement with access , and where the number of parties in the negotiation ï쳌­ ï쳌© ï쳌² ï쳌¥ ï쳌® ï쳌¥ ï쳌­ which allows ï쳌© ï쳌® ï쳌¢ io to broker contracts for access and permitting process is minimized . The process envi - to resources on certain public lands as long as ï쳌© ï쳌® ï쳌¢ io obtains sioned in the Law of Biodiversity appears to move Costa the permits mandated by the ï쳌¬ ï쳌· ï쳌£ . Furthermore , the ï?? ï?? ï?? ï?? Rica away from these norms . ï쳌­ ï쳌© ï쳌² ï쳌¥ ï쳌® ï쳌¥ ï쳌­ / ï쳌© ï쳌® ï쳌¢ io agreement sets a target for bioprospecting projects that ï?? ï?? % of a projectâ??s annual research budget ï쳌µ ï쳌³ ï쳌¡ . Similarly to other countries , the ï쳌µ ï쳌³ ï쳌¡ has a brief histo - and ï?? ï?? % of future royalties from the project that accrue ry regulating ï쳌¡ ï쳌¢ ï쳌³ with regard to its own genetic resources . to ï쳌© ï쳌® ï쳌¢ io must be donated to the National Parks Fund to The countryâ??s experiment with ï쳌¡ ï쳌¢ ï쳌³ of national biological be reinvested in conservation ( S ï쳌© ï쳌´ ï쳌´ ï쳌¥ ï쳌® ï쳌¦ ï쳌¥ ï쳌¬ ï쳌¤ and G ï?¡ ï쳌­ ï쳌¥ ï쳌º resources is represented in this report by a single case , ï?? ï?? ï?? ï?? ) . Between ï?? ï?? ï?? ï?? and ï?? ï?? ï?? ï?? , ï?? ï?? . ï?? million USD have the contract between the Yellowstone National Park and been invested in conservation ( see Chapter ï?? ) . By working Diversa Corporation for access to thermophilic bacteria in designated conservation areas , such as the Guanacaste found in the hot springs of Yellowstone National Park . National Park , ï쳌© ï쳌® ï쳌¢ io is alleviated from the need to negoti - The Yellowstone â?? Diversa contract ( i.e . , a Cooperative ate with landholders and local communities . Likewise , the Research and Development Agreement ( ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ ) ) is simi - sharing of benefits is facilitated by ï쳌© ï쳌® ï쳌¢ ioâ??s scientific and lar to the Merck â?? ï쳌© ï쳌® ï쳌¢ io agreement in several ways . Both educational role and by its special relation to the National were negotiated outside of the specific ï쳌£ ï쳌¢ ï쳌¤ context . In Park system and ï쳌­ ï쳌© ï쳌² ï쳌¥ ï쳌® ï쳌¥ ï쳌­ . These factors help ï쳌© ï쳌® ï쳌¢ io and Costa Ricaâ??s case , the deal was agreed to before the ï쳌£ ï쳌¢ ï쳌¤ , its international partners to minimize transaction costs in and the ï쳌µ ï쳌³ ï쳌¡ case involves a country that is not party to the negotiating for access and distribution of benefits . By act - ï쳌£ ï쳌¢ ï쳌¤ . Like ï쳌© ï쳌® ï쳌¢ io , Yellowstone National Park was created ing as a singular and nongovernmental authority in nego - before any ï쳌¡ ï쳌¢ ï쳌³ policy was conceived , and both the park tiating access and benefits , ï쳌© ï쳌® ï쳌¢ io reduces the complexity and the institute had well - defined conservation missions of negotiating with private firms and universities . Finally , before entering into bioprospecting contracts . ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ The Merck â?? ï쳌© ï쳌® ï쳌¢ io and Yellowstone â?? Diversa cases anticipated the possibility of a benefit stream back to the federal partner ( See Chapter ï?? ) . The vehicle that the ï쳌¦ ï쳌´ ï쳌´ ï쳌¡ differ in their genesis . In Costa Rica , negotiations over promoted for increasing ï쳌¡ ï쳌¢ ï쳌³ goals between federally fund - access and benefits preceded bioprospecting activities , 7 ed programs and private businesses was the ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ . The while in Yellowstone , bioprospecting preceded negotia - ï?? ï?? ï?? ï?? Yellowstone National Park â?? Diversa ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ provided tions over access and benefits . The Yellowstone â?? Diversa access to thermophilic and other biological resources of ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ , negotiated in ï?? ï?? ï?? ï?? , followed the commercial Yellowstone National Park to Diversa in return for short - success of using biological specimens from Yellowstone and long - term financial returns ( see Chapter ï?? ) . While to create an essential tool for the biotechnology industry . the Yellowstone â?? Diversa agreement was challenged as a The Cetus Corporation obtained samples of the Thermus violation of the public trust and the conservation mission aquaticus bacteria that had been collected in ï?? ï?? ï?? ï?? and ofYellowstone National Park , the challenge was dismissed deposited with the American Type Culture Collection by a federal court in ï?? ï?? ï?? ï?? . TheYellowstone â?? Diversa agree - ( ï쳌¡ ï쳌´ ï쳌£ ï쳌£ ) , a nonprofit organization established in ï?? ï?? ï?? ï?? as ment has led both to new products for the company and a resource center for biological products . ï쳌¡ ï쳌´ ï쳌£ ï쳌£ acquires , to financial support from the company to the park for its authenticates , preserves , and distributes biological materi - conservation work ( see Chapter ï?? ) . als . Biological specimens , such as Thermus aquaticus , are The success of this project is noteworthy because it oc - held as public goods by ï쳌¡ ï쳌´ ï쳌£ ï쳌£ , and ï쳌¡ ï쳌´ ï쳌£ ï쳌£ does not claim curred outside of the ï쳌£ ï쳌¢ ï쳌¤ framework . Success in this case intellectual property over them . owes to the legislative context of technology transfer in the Cetus had acquired the original sample of Thermus ï쳌µ ï쳌³ ï쳌¡ that was created to enhance private access to publicly aquaticus from ï쳌¡ ï쳌´ ï쳌£ ï쳌£ in ï?? ï?? ï?? ï?? as a public good . The owned knowledge and resources . Benefit sharing was not specimens of Thermus aquaticus were deposited with unimportant , and it clearly was one intended outcome of ï쳌¡ ï쳌´ ï쳌£ ï쳌£ before it had established a special collection and access , but it was secondary . As in the Merck â?? ï쳌© ï쳌® ï쳌¢ io case , material procedure with the ï쳌µ ï쳌³ ï쳌¡ National Park Service the negotiations were confined to immediate parties â?? the ( ï쳌® ï쳌° ï쳌³ ) . ï쳌¡ ï쳌´ ï쳌£ ï쳌£ now maintains a special collection of biologi - company andYellowstone National Park . Success was also cal materials from the ï쳌® ï쳌° ï쳌³ , including Thermus aquaticus due to the decentralized nature of the federal governmentâ??s from Yellowstone and has a material transfer agreement approach . Rather than a centralized system for negotiat - for the ï쳌® ï쳌° ï쳌³ collections which requires that the person re - ing agreements , by default the ï쳌µ ï쳌³ ï쳌¡ has a de facto loose questing material acknowledge ownership by the federal framework that allowed and encouraged these agreements . government , agree to use the material , its replicates , and Chapter ï?? notes the â?? dizzying array of laws , regulations , derivatives for research only and not commercial purposes and policies â?쳌 that exists in the ï쳌µ ï쳌³ ï쳌¡ at different political lev - without authorization , and agree to inform the ï쳌® ï쳌° ï쳌³ of find - els and jurisdictions and prevents a centralized approach . ings from the material , its replicates , or derivatives . Moreover , Chapter ï?? reminds us that the ï쳌® ï쳌° ï쳌³ followed a Thermus aquaticus proved to be highly valuable pragmatic approach that emphasized efficiency in refer - because it included a heat - stable enzyme named Taq ence to ï쳌¡ ï쳌¢ ï쳌³ goals and resulted in conservation benefits polymerase that facilitated efficient , controlled replica - for the national park rather than a philosophical approach tion of DNA . The commercial success of patenting , sale , based on disputing private benefit from access to public and licensing of Taq led to recommendations from several goods . As in the case of Costa Ricaâ??s early bioprospect - groups and political leaders in the ï쳌µ ï쳌³ ï쳌¡ that the ï쳌® ï쳌° ï쳌³ begin ing experience , decentralization favored the success of the to regulate access and to seek benefits from its biological Yellowstone â?? Diversa project . resources ( see Chapter ï?? ) . The ï쳌¡ ï쳌¢ ï쳌³ approach followed by the ï쳌® ï쳌° ï쳌³ was to adopt Mixed Success and Breakdown the framework of the ï?? ï?? ï?? ï?? Federal Technology Transfer The case studies of Mexico and the Philippines offer ex - Act ( ï쳌¦ ï쳌´ ï쳌´ ï쳌¡ ) whose purpose was to facilitate access by the amples of ï쳌¡ ï쳌¢ ï쳌³ regimes that had initial implementation suc - private sector to knowledge and technology developed by cess but also saw the implementation process breakdown government agencies or with public funding . The emphasis with the closing of nascent bioprospecting projects . These of this act is on access rather than benefit sharing ( A ï쳌° ï쳌¥ ï쳌® et cases show the difficulties inherent in involving different al . ï?? ï?? ï?? ï?? ) . Increased access was meant to increase the rate institutions and communities in a national program to meet of return on public investment and thus provide increased the general goals of the ï쳌£ ï쳌¢ ï쳌¤ . social benefit . The underlying logic of ï쳌¦ ï쳌´ ï쳌´ ï쳌¡ is that access to knowledge , for instance through exclusive licensing of Mexico . Unlike the Costa Rica and ï쳌µ ï쳌³ ï쳌¡ cases , Mexico patents held by government laboratories , will facilitate created a post - ï쳌£ ï쳌¢ ï쳌¤ national legislative ï쳌¡ ï쳌¢ ï쳌³ framework as the development and diffusion of new technology and part of environmental protection before the negotiation of thereby provide for benefit sharing by enhancing social specific agreements . This framework is primarily outlined welfare . ï쳌¦ ï쳌´ ï쳌´ ï쳌¡ was one of several laws passed to enhance in articles ï?? ï?? and ï?? ï?? ï쳌¢ ï쳌© ï쳌³ of the ï?? ï?? ï?? ï?? Ecological Equilibrium commercial development of publicly owned knowledge or and Environmental Protection General Act ( ï쳌¥ ï쳌¥ ï쳌¥ ï쳌° ï쳌§ ï쳌¡ ) that resources and to increase private investment in research regulate access to all species for commercial and noncom - that had been initiated by public agencies ( A ï쳌° ï쳌¥ ï쳌® et al . mercial purposes . In addition , the ï?? ï?? ï?? ï?? Wildlife General ï?? ï?? ï?? ï?? ) . Although the ï쳌¦ ï쳌´ ï쳌´ ï쳌¡ emphasized access , it also Act ( ï쳌· ï쳌§ ï쳌¡ ) and the ï?? ï?? ï?? ï?? Sustainable Forestry Development ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : I ï쳌­ ï쳌° ï쳌¬ ï쳌¥ ï쳌­ ï쳌¥ ï쳌® ï쳌´ ï쳌¡ ï쳌´ ï쳌© ï쳌¯ ï쳌® P ï쳌¡ ï쳌´ ï쳌¨ ï쳌· ï쳌¡ ï쳌¹ ï쳌³ General Act include relevant ï쳌¡ ï쳌¢ ï쳌³ provisions that apply American Home Products Corporationâ??s Wyeth - Ayerst specifically to wildlife and forest resources , respectively . Research Laboratories , andAmerican Cyanamid Company While Articles ï?? ï?? and ï?? ï?? ï쳌¢ ï쳌© ï쳌³ provide general ï쳌¡ ï쳌¢ ï쳌³ prin - ( T ï쳌© ï쳌­ ï쳌­ ï쳌¥ ï쳌² ï쳌­ ï쳌¡ ï쳌® ï쳌® et al . ï?? ï?? ï?? ï?? ) . This project also sought the ciples , national legislation does not specifically address de - participation of local communities and associations such tails about how to implement these principles ( see Chapter as the Association of Traditional Healers of Oaxaca ï?? ) . Article ï?? ï?? outlines authorization for the collection of ( T ï쳌© ï쳌­ ï쳌­ ï쳌¥ ï쳌² ï쳌­ ï쳌¡ ï쳌® et al . ï?? ï?? ï?? ï?? ) , although they were not parties 8 wildlife species for scientific and economic purposes and to the main agreement . Nevertheless , these communities Article ï?? ï?? ï쳌¢ ï쳌© ï쳌³ provides authorization for the collection of received nonmonetary benefits that included urban and wildlife species and other biological resources for com - rural health centers and training for the cultivation of mercial utilization . A key aspect of Article ï?? ï?? ï쳌¢ ï쳌© ï쳌³ is the medicinal plants ( T ï쳌© ï쳌­ ï쳌­ ï쳌¥ ï쳌² ï쳌­ ï쳌¡ ï쳌® ï쳌® et al . ï?? ï?? ï?? ï?? ) . obligation for bioprospecting projects to obtain ï쳌° ï쳌© ï쳌£ from The fourth project involved a civil society organiza - the Mexican government as well as from the landowner tion representing indigenous communities ( the Zapotec where collection is anticipated . Moreover , this article also and Chinantec Communities Union â?? ï쳌µ ï쳌º ï쳌¡ ï쳌£ ï쳌¨ ï쳌© ) in the state requires applicants to share benefits with the owners of the of Oaxaca and the Sandoz Corporation to access micro - land where collections are made . scopic fungi . The member communities of ï쳌µ ï쳌º ï쳌¡ ï쳌£ ï쳌¨ ï쳌© were Like the Merck â?? ï쳌© ï쳌® ï쳌¢ io and Yellowstone â?? Diversa the Mexican beneficiaries . agreements , the four Mexican projects we discuss were The ï쳌µ ï쳌® ï쳌¡ ï쳌­ â?? Diversa and the Latin American ï쳌© ï쳌£ ï쳌¢ ï쳌§ negotiated outside of a national legal ï쳌¡ ï쳌¢ ï쳌³ framework or agreements are the most similar to the Merck â?? ï쳌© ï쳌® ï쳌¢ io and centralized approach . However , after negotiation , the Yellowstone â?? Diversa agreements . Like these , the ï쳌µ ï쳌® ï쳌¡ ï쳌­ â?? first three of these four projects , summarized below , were Diversa and Latin American ï쳌© ï쳌£ ï쳌¢ ï쳌§ agreements involved granted access permits under environmental legislation an independent institution that was given permission to that did include ï쳌¡ ï쳌¢ ï쳌³ principles ( i.e . , Article ï?? ï?? and ï?? ï?? ï쳌¢ ï쳌© ï쳌³ facilitate access to public resources by a private company of the ï쳌¥ ï쳌¥ ï쳌¥ ï쳌° ï쳌§ ï쳌¡ ) . The fourth project was authorized before and that would benefit from commercialization of dis - ï쳌¡ ï쳌¢ ï쳌³ principles were incorporated into the ï쳌¥ ï쳌¥ ï쳌¥ ï쳌° ï쳌§ ï쳌¡ . coveries resulting from this access . In all four cases , the The first project was between the NationalAutonomous negotiation of the contract took place with a minimum of University of Mexico ( ï쳌µ ï쳌® ï쳌¡ ï쳌­ ) and the Diversa Corporation different parties and a lack of major constraints by a cen - to access biological materials from public lands and natural tralized framework for reviewing the contract . In addition , protected areas in Mexico . ï쳌µ ï쳌® ï쳌¡ ï쳌­ â?? s rights to collect under the ï쳌µ ï쳌º ï쳌¡ ï쳌£ ï쳌¨ ï쳌© â?? Sandoz and Maya ï쳌© ï쳌£ ï쳌¢ ï쳌§ agreements involved this agreement were accepted and facilitated by three fed - civil society organizations and rural communities of indig - eral agencies with responsibility for federal public land enous people . Of all the agreements discussed so far , the and protected areas . In this case , ï쳌µ ï쳌® ï쳌¡ ï쳌­ was the Mexican Maya ï쳌© ï쳌£ ï쳌¢ ï쳌§ is the most complex in terms of the number and beneficiary . diversity of actors and source of financial backing . The second project , known as the Maya ï쳌© ï쳌£ ï쳌¢ ï쳌§ , was Three of the Mexican agreements faced political chal - negotiated and launched in the southern Mexican state lenge , legal uncertainties , and termination before accom - of Chiapas . The direct partners were a group of partici - plishment . The challenge to each was made in a different pating Mayan communities in the Chiapas highlands , a way . The ï쳌µ ï쳌® ï쳌¡ ï쳌­ â?? Diversa agreement was challenged as a national educational and research institution ( ï쳌¥ ï쳌£ ï쳌¯ ï쳌³ ï쳌µ ï쳌² ) , the vehicle for the inappropriate expropriation of publicly University of Georgia in the ï쳌µ ï쳌³ ï쳌¡ , and Molecular Nature owned resources ( see Chapter ï?? ) . Even though the project Limited , a biotechnology company from the United had been granted access under Article ï?? ï?? ï쳌¢ ï쳌© ï쳌³ of ï쳌¥ ï쳌¥ ï쳌¥ ï쳌° ï쳌§ ï쳌¡ Kingdom . The aim of the project was to access biota in ( which regulates collection of samples for biotechnological highland Chiapas that the Maya knew to have medicinal purposes ) , it had a specifically noncommercial scientific properties and to ensure the equitable distribution of ben - goal not a biotechnological one . Collection activities un - efits derived from that utilization . The Mexican beneficia - der the ï쳌µ ï쳌® ï쳌¡ ï쳌­ â?? Diversa agreement were suspended after a ries of the project were to be ï쳌¥ ï쳌£ ï쳌¯ ï쳌³ ï쳌µ ï쳌² and the participating legal challenge to the Federal Attorney for the Protection Mayan communities . of the Environment ( ï쳌° ï쳌² ï쳌¯ ï쳌¦ ï쳌¥ ï쳌° ï쳌¡ ) resulted in additional ï쳌° ï쳌© ï쳌£ The third project , known as the Latin American ï쳌© ï쳌£ ï쳌¢ ï쳌§ , requirements under Article ï?? ï?? ï쳌¢ ï쳌© ï쳌³ from the providers of focused on collecting plant material from arid ecosys - genetic resources . The project expired in ï?? ï?? ï?? ï?? . tems in the states of Chihuahua , Oaxaca , and San Luis The Maya ï쳌© ï쳌£ ï쳌¢ ï쳌§ project initiated collection activities Potosi , but it also sampled xerophytic plants available for scientific purposes but it was vigorously challenged by for sale in local markets . Colleting in local markets also civil society organizations in Chiapas and by international permitted the analysis of each regionâ??s medicinal plant organizations that claimed the project was relying on its trade network and the evaluation of the collection pres - ties to a limited number of communities to expropriate sure upon wild populations of plants . The University of resources that were widely shared among many other Arizona in the ï쳌µ ï쳌³ ï쳌¡ coordinated this project , ï쳌µ ï쳌® ï쳌¡ ï쳌­ was communities ( N ï쳌© ï쳌§ ï쳌¨ ï?? ï?? ï?? ï?? ) . These organizations further again the main Mexican beneficiary , and plant material objected to the possibility of patents being obtained on was screened by ï쳌µ ï쳌® ï쳌¡ ï쳌­ in Mexico and by three organi - products derived from biological collections from Chiapas . zations in the ï쳌µ ï쳌³ ï쳌¡ : G.W.L . Hansenâ??s Disease Center , National and international political pressure resulted in the ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ withdrawal of ï쳌¥ ï쳌£ ï쳌¯ ï쳌³ ï쳌µ ï쳌² and funding from the consortium the Philippines established an ï쳌­ ï쳌¯ ï쳌µ for collecting biological of ï쳌µ ï쳌³ ï쳌¡ agencies , before the ï쳌© ï쳌£ ï쳌¢ ï쳌§ could obtain the full ï쳌° ï쳌© ï쳌£ specimens , although this framework was not specifically from local communities that was required for authoriza - designed to facilitate ï쳌¡ ï쳌¢ ï쳌³ goals , it allowed the signing of tion under Article ï?? ï?? ï쳌¢ ï쳌© ï쳌³ of ï쳌¥ ï쳌¥ ï쳌¥ ï쳌° ï쳌§ ï쳌¡ . However , B ï쳌¥ ï쳌² ï쳌¬ ï쳌© ï쳌® and an agreement ( i.e . , ï쳌¬ ï쳌© ) between the Philippine National B ï쳌¥ ï쳌² ï쳌¬ ï쳌© ï쳌® ( ï?? ï?? ï?? ï?? ) document the extensive effort made by the Museum and the ï쳌µ ï쳌³ ï쳌¡ National Cancer Institute that ac - project participants to obtain ï쳌° ï쳌© ï쳌£ and the belief by them that complished both access and benefit sharing to a degree it had been obtained . They conclude that ï쳌° ï쳌© ï쳌£ may always be ( see Chapter ï?? ) . In contrast , the framework established ambiguous and open to challenge . The samples collected under ï쳌¥ ï쳌¯ ï?? ï?? ï?? employs a contractual approach and entails by this ï쳌© ï쳌£ ï쳌¢ ï쳌§ under Article ï?? ï?? never left the country ( J.C . two types of collecting agreements depending on whether Fernandez , pers . comm . April ï?? ï?? ï?? ï?? ) . they are Commercial Research Agreements ( ï쳌£ ï쳌² ï쳌¡ ) or The Latin American ï쳌© ï쳌£ ï쳌¢ ï쳌§ was granted access under Academic Research Agreements ( ï쳌¡ ï쳌² ï쳌¡ ) , a centralized Article ï?? ï?? of ï쳌¥ ï쳌¥ ï쳌¥ ï쳌° ï쳌§ ï쳌¡ . However , because of the commercial review process , ï쳌° ï쳌© ï쳌£ stipulations , and environmental pro - and biotechnological nature of the project , access should tection requirements . The Wildlife Act modified this by have been granted under Article ï?? ï?? ï쳌¢ ï쳌© ï쳌³ that regulates the freeing academic and scientific research from commercial collection of samples for biotechnological purposes ( see bioprospecting requirements . The ï?? ï?? ï?? ï?? draft Guidelines Chapter ï?? ) . This legal inconsistency , the controversy raised for Bioprospecting Activities in the Philippines , that will by the fact that samples were being collected at local mar - implement the Wildlife Act , require commercial biopros - kets , and fears that this project might be as controversial as pectors to apply for a Biopropsecting Undertaking instead the Maya ï쳌© ï쳌£ ï쳌¢ ï쳌§ prompted the decision to deny access under of a ï쳌£ ï쳌² ï쳌¡ . According to the draft guidelines , commercial article ï?? ï?? ï쳌¢ ï쳌© ï쳌³ ( J.C . Fernandez , pers . comm . April ï?? ï?? ï?? ï?? ) . bioprospectors may have to pay a bioprospecting fee of The most successful Mexican project was the ï쳌µ ï쳌º ï쳌¡ ï쳌£ ï쳌¨ ï쳌© â?? ï?? ï?? , ï?? ï?? ï?? ï쳌µ ï쳌³ ï쳌¤ for each Bioprospecting Undertaking and Sandoz project . Although that project was also challenged ï?? ï?? , ï?? ï?? ï?? per collection site annually during the collection politically locally and internationally , the challenges did period . Furthermore , commercial bioprospectors must be not result in suspension or closure because of the sup - prepared to pay a minimum amount of ï?? % of the gross port by indigenous communities and the recognition that sales of products made or derived from collected samples , ï쳌µ ï쳌º ï쳌¡ ï쳌£ ï쳌¨ ï쳌© was acting within its legal rights to enter into and in addition to some minimum nonmonetary benefits ( see execute the agreement . The ï쳌µ ï쳌º ï쳌¡ ï쳌£ ï쳌¨ ï쳌© â?? Sandoz agreement Chapters ï?? and ï?? ) . A major issue in the Philippines â?? ï쳌¡ ï쳌¢ ï쳌³ was not renewed due to the unclear regulatory power of policies is to protect the interests of indigenous people and the national ï쳌¡ ï쳌¢ ï쳌³ framework ( see Chapter ï?? ) . their traditional knowledge ; the draft guidelines outline Issues that played in the uneven experience of Mexico detailed ï쳌° ï쳌© ï쳌£ procedures to this effect . include an incomplete legal ï쳌¡ ï쳌¢ ï쳌³ framework , uncertainty Two out of ï?? ï?? projects presented between ï?? ï?? ï?? ï?? and over local authority to grant access , social controversy , and ï?? ï?? ï?? ï?? have been approved under ï쳌¥ ï쳌¯ ï?? ï?? ï?? ( Chapter ï?? ) . The institutional complexity within the bioprospecting projects . fact that no projects have been presented since October The legal framework that confronted the ï쳌µ ï쳌® ï쳌¡ ï쳌­ â?? Diversa ï?? ï?? ï?? ï?? implies that the frameworks developed under ï쳌¥ ï쳌¯ agreement involved a â?? popular denunciation â?쳌 to the ï쳌° ï쳌² ï쳌¯ - ï?? ï?? ï?? have discouraged collectors from initiating new ac - ï쳌¦ ï쳌¥ ï쳌° ï쳌¡ office , but that office averred that it did not have the tivities . Of the ï?? ï?? projects presented between ï?? ï?? ï?? ï?? and authority to void the agreement . Nevertheless , the ï쳌° ï쳌² ï쳌¯ ï쳌¦ ï쳌¥ ï쳌° ï쳌¡ ï?? ï?? ï?? ï?? , eight were from foreign universities or companies , office asked that the parties of the agreement revisit the one was from an international agricultural center located issue of ï쳌° ï쳌© ï쳌£ under Article ï?? ï?? ï쳌¢ ï쳌© ï쳌³ of ï쳌¥ ï쳌¥ ï쳌¥ ï쳌° ï쳌§ ï쳌¡ even though in the Philippines , and ï?? ï?? were submitted by Philippine this appeared to have been adequately negotiated in the institutions . The large majority of both foreign and national original agreement with the intervention of the Secretariat projects involved academic and research institutions rather of Environment and Natural Resources and other federal than commercial interests . The only approved foreign ap - authorities . The ï쳌° ï쳌² ï쳌¯ ï쳌¦ ï쳌¥ ï쳌° ï쳌¡ decision left the agreement in plication came about with a ï쳌£ ï쳌² ï쳌¡ under ï쳌¥ ï쳌¯ ï?? ï?? ï?? and appears an indeterminate state that ultimately led to its expiration to be nearing accomplishment . This is a collaboration be - without fulfillment . The problems caused by legal ambi - tween the University of Utah in the ï쳌µ ï쳌³ ï쳌¡ and the University guity are exacerbated in situations where bioprospecting of the Philippines Marine Science Institute . None of the agreements are associated with social controversy . This foreign projects that have moved successfully through the situation is typified by the two ï쳌© ï쳌£ ï쳌¢ ï쳌§ projects , which were review process involve collection of biological specimens also encumbered by institutional complexity because of the on land or involve indigenous people or traditional knowl - involvement of different types of national and international edge . Six of the eight foreign projects and the project of organizations and the reliance on extramural financing . the international agricultural research center have either been withdrawn , required to submit further material , or Philippines . This nationâ??s response to the ï쳌¡ ï쳌¢ ï쳌³ provisions are pending , sometimes several years after the original ap - of the ï쳌£ ï쳌¢ ï쳌¤ is embedded in the ï?? ï?? ï?? ï?? Executive Order No . plication date . The same low rate of approval characterizes ï?? ï?? ï?? ( ï쳌¥ ï쳌¯ ï?? ï?? ï?? ) , its ï?? ï?? ï?? ï?? implementing rules and regulations , projects submitted by Philippine institutions . Only one ï쳌¡ ï쳌² ï쳌¡ and the ï?? ï?? ï?? ï?? Republic Act No . ï?? ï?? ï?? ï?? , also known as the has been approved for the University of the Philippines . It Wildlife Resources Conservation and ProtectionAct ( here - after , Wildlife Act ) . Prior to this legal framework , in ï?? ï?? ï?? ï?? should be noted that while the ï쳌£ ï쳌² ï쳌¡ was approved in a bit ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : I ï쳌­ ï쳌° ï쳌¬ ï쳌¥ ï쳌­ ï쳌¥ ï쳌® ï쳌´ ï쳌¡ ï쳌´ ï쳌© ï쳌¯ ï쳌® P ï쳌¡ ï쳌´ ï쳌¨ ï쳌· ï쳌¡ ï쳌¹ ï쳌³ more than a year , the ï쳌¡ ï쳌² ï쳌¡ took two and a half years until purposes , predominantly by Colombian scientists . Only the Technical Secretariat gave its approval . two of these projects involved the participation of inter - It is difficult to know exactly why there is such a low national organizations . approval rate and lengthy application procedure for bio - Several factors thwarted Colombiaâ??s ability to move prospecting projects in the Philippines . It may be related these projects forward , and among these , three stand out . to the fact that ï쳌° ï쳌© ï쳌£ requirements under ï쳌¥ ï쳌¯ ï?? ï?? ï?? involve a First is the evident lack of knowledge and confusion on lengthy application process and the national framework both the access and benefit side . Second was the transaction presents a complex system of different types of applica - costs of obtaining information and negotiating agreements tion procedures and levels of approval that feed into a under Decision ï?? ï?? ï?? . Third was unreasonably high expecta - centralized system . Although ï쳌¥ ï쳌¯ ï?? ï?? ï?? and the Wildlife Act tions about economic benefits , especially when most of seek a contractual approach , the role of the centralized the projects were academic rather than commercial . These review and permitting process mean that the two parties problems were exacerbated by Colombiaâ??s lack of techni - interested in a contract are not acting alone . If adopted , cal capacity and expertise to handle access applications the Guidelines for Bioprospecting Activities are likely to and interpret key provisions of Decision ï?? ï?? ï?? . Furthermore , reduce transaction costs by streamlining application and there is confusion and uncertainty about policy and institu - negotiation requirements for commercial bioprospectors tional needs required to implement Decision ï?? ï?? ï?? . Perhaps ( see Chapter ï?? for detailed access procedures ) . the sharpest contrast between Colombiaâ??s approach and the approach taken in the more successful efforts discussed Thwarted Implementation above is centralization through Decision ï?? ï?? ï?? . The applica - Colombia . This nation has experienced great difficulty tion of this ï쳌¡ ï쳌¢ ï쳌³ law occurred before individual negotiations in launching bioprospecting projects since negotiation between potential partners could occur , and this deeply af - in ï?? ï?? ï?? ï?? of the Common Regime on Access to Genetic fected negotiations . In contrast , the successful instances of Resources ( Decision ï?? ï?? ï?? ) of the Andean Community . negotiating and initiating bioprospecting projects discussed None of the projects that were submitted since Decision above occurred in contexts characterized by the presence ï?? ï?? ï?? came into force have been approved or implemented . of organizations with mutual interests and objectives that Chapter ï?? provides information on ï?? ï?? bioprospecting proj - were able to operate under decentralized and flexible ects submitted between February ï?? ï?? ï?? ï?? and February ï?? ï?? ï?? ï?? . national policy frameworks . Examples of these are Costa One was declined , three withdrawn , and ï?? ï?? are still pend - Ricaâ??s ï쳌© ï쳌® ï쳌¢ io agreements , the ï쳌µ ï쳌³ ï쳌¡ Yellowstone â?? Diversa ing . Only one of the ï?? ï?? projects submitted was commercial in nature and the rest were for academic and conservation agreement , and Mexicoâ??s ï쳌µ ï쳌º ï쳌¡ ï쳌£ ï쳌¨ ï쳌© â?? Sandoz agreement . Lessons A decade after the promulgation of the ï쳌£ ï쳌¢ ï쳌¤ , the prospects of this are the numerous agreements signed in Costa Rica for creating successful national ï쳌¡ ï쳌¢ ï쳌³ policies are guarded . under the ï?? ï?? ï?? ï?? ï쳌¬ ï쳌· ï쳌£ and its ï?? ï?? ï?? ï?? regulation but before the Although there are several cases of successful bioprospect - ï?? ï?? ï?? ï?? Law of Biodiversity was enacted . In December ï?? ï?? ï?? ï?? ing projects , closer examination of these suggests that the the ï쳌© ï쳌£ ï쳌¢ ï쳌§ program approved a planning grant for a project actors and interests who join in them still face serious ob - that will be carried out by Harvard University and ï쳌© ï쳌® ï쳌¢ io in stacles to forming effective partnerships . Five lessons can Costa Rica . This project will test the efficiency and effec - be drawn from this review of Pacific Rim case studies . tiveness of the ï쳌¡ ï쳌¢ ï쳌³ provisions of the Law of Biodiversity . First , agreements are most likely to succeed when the Colombiaâ??s difficulties stem to some degree from the fact number of parties is minimized . Two immediate parties that this country not only had to address national inter - in projects are the collector and the agency or social en - ests and policies in reviewing access proposals , but it also tity that is recognized as being the competent authority had to harmonize its national policies with Decision ï?? ï?? ï?? . to grant access . For example , in Costa Rica , ï쳌© ï쳌® ï쳌¢ io was Furthermore , difficulties in regionwide implementation of authorized to negotiate access to biological resources in Decision ï?? ï?? ï?? have led Colombia and the other members of certain areas , and in the ï쳌µ ï쳌³ ï쳌¡ , the National Park Service theAndean Community of Nations to a revision of this law granted Yellowstone National Park authority to negotiate ( M . Ruiz , pers . comm.April ï?? ï?? ï?? ï?? ) . In summary , simplicity access to resources within the park . Likewise in Mexico , and directness in negotiating and approving agreements the ï쳌µ ï쳌º ï쳌¡ ï쳌£ ï쳌¨ ï쳌© â?? Sandoz agreement involved only local inter - under ï쳌¡ ï쳌¢ ï쳌³ laws and policies is a strong virtue . ests . Moving the locus of negotiation and agreement away Second , the determination of a competent authority from the immediate parties , for instance by setting up a or local focal point in granting access is critical , and complex national ï쳌¡ ï쳌¢ ï쳌³ framework with multiple participants ambiguity in this is problematic . The ï쳌© ï쳌® ï쳌¢ io , Yellowstone , and interests , tends to encumber negotiation , agreement , and ï쳌µ ï쳌º ï쳌¡ ï쳌£ ï쳌¨ ï쳌© agreements mentioned above illustrate this and accomplishment . The most successful bioprospect - conclusion . ing projects were established outside of focused national Third , the determination of clear access procedures and frameworks corresponding to the ï쳌£ ï쳌¢ ï쳌¤ . A prime example particularly ï쳌° ï쳌© ï쳌£ requirements are essential to expedite the ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ approval of applications and the negotiation of benefits . ity needs to be transferred to local organizations that may be involved in the negotiation of benefits . The tendency for successful projects in Costa Rica , the Fifth , creating a forum for balanced discussion of con - Philippines , and elsewhere to focus on biological resources troversial ï쳌¡ ï쳌¢ ï쳌³ concepts and implications may facilitate the that are not controlled or used by local people suggests application process and accomplishment of bioprospecting that decisiveness in defining effective ï쳌° ï쳌© ï쳌£ requirements is projects . As demonstrated by the Mexican experience the crucial . The efforts of the Maya ï쳌© ï쳌£ ï쳌¢ ï쳌§ project in Mexico novel , complex , controversial , and experimental nature of to acquire ï쳌° ï쳌© ï쳌£ proved insufficient to ward off a challenge . ï쳌¡ ï쳌¢ ï쳌³ concepts make bioprospecting projects particularly B ï쳌¥ ï쳌² ï쳌¬ ï쳌© ï쳌® and B ï쳌¥ ï쳌² ï쳌¬ ï쳌© ï쳌® ( ï?? ï?? ï?? ï?? ) , who were leading participants open to challenge . While some organizations may be in the Maya ï쳌© ï쳌£ ï쳌¢ ï쳌§ project , observed that ï쳌° ï쳌© ï쳌£ is inevitably against bioprospecting initiatives , other groups like the ambiguous and open to challenge . ï쳌µ ï쳌º ï쳌¡ ï쳌£ ï쳌¨ ï쳌© may have a different perspective . Positive experi - Fourth , governments need to build local capacity to ences where the primary users and stewards of biological facilitate the effective and efficient implementation of ï쳌¡ ï쳌¢ ï쳌³ diversity are clear beneficiaries of bioprospecting projects laws and policies . Lack of trained evaluators and negotia - are likely to create a favorable political and social environ - tors result in delayed responses for project applications and ment for accomplishing them . missed opportunities for benefit sharing as demonstrated by the Philippines and Colombian experiences . This capac - References A ï쳌° ï쳌¥ ï쳌® P.G . , B.C . B ï쳌¥ ï쳌® ï쳌© ï쳌£ ï쳌¥ ï쳌· ï쳌© ï쳌£ ï쳌º , and J.R . L ï쳌¡ ï쳌© ï쳌¡ . ï?? ï?? ï?? ï?? . A new R ï쳌¥ ï쳌© ï쳌¤ W.V . , S.A . L ï쳌¡ ï쳌© ï쳌² ï쳌¤ , R . G ï?¡ ï쳌­ ï쳌¥ ï쳌º , A . S ï쳌© ï쳌´ ï쳌´ ï쳌¥ ï쳌® ï쳌¦ ï쳌¥ ï쳌¬ ï쳌¤ , D.H . model for public - private partnerships . Technology in J ï쳌¡ ï쳌® ï쳌º ï쳌¥ ï쳌® , M.G . G ï쳌¯ ï쳌¬ ï쳌¬ ï쳌© ï쳌® , and C . J ï쳌µ ï쳌­ ï쳌¡ . ï?? ï?? ï?? ï?? . A new lease Society ï?? ï?? : ï?? ï?? ï?? â?? ï?? ï?? ï?? . on life . p . ï?? â?? ï?? ï?? in W.V . R ï쳌¥ ï쳌© ï쳌¤ , S.A . L ï쳌¡ ï쳌© ï쳌² ï쳌¤ , C.A . M ï쳌¥ ï쳌¹ ï쳌¥ ï쳌² , R . G ï?¡ ï쳌­ ï쳌¥ ï쳌º , A . S ï쳌© ï쳌´ ï쳌´ ï쳌¥ ï쳌® ï쳌¦ ï쳌¥ ï쳌¬ ï쳌¤ , D.H . J ï쳌¡ ï쳌® ï쳌º ï쳌¥ ï쳌® , M.G . G ï쳌¯ ï쳌¬ ï쳌¬ ï쳌© ï쳌® , B ï쳌¥ ï쳌² ï쳌¬ ï쳌© ï쳌® B . and E.A . B ï쳌¥ ï쳌² ï쳌¬ ï쳌© ï쳌® . ï?? ï?? ï?? ï?? . ï쳌® ï쳌§ ï쳌¯ s and the process of and C . J ï쳌µ ï쳌­ ï쳌¡ ( eds . ) Biodiversity prospecting : Using prior informed consent in bioprospecting research : The genetic resources for sustainable development . World Maya ï쳌© ï쳌£ ï쳌¢ ï쳌§ project in Chiapas , Mexico . International Resources Institute , ï쳌µ ï쳌³ ï쳌¡ . Social Science Journal ï?? ï?? : ï?? ï?? ï?? â?? ï?? ï?? ï?? . R ï쳌¯ ï쳌³ ï쳌¥ ï쳌® ï쳌´ ï쳌¨ ï쳌¡ ï쳌¬ J.P . , D . B ï쳌¥ ï쳌£ ï쳌« , A . B ï쳌¨ ï쳌¡ ï쳌´ , J . B ï쳌© ï쳌³ ï쳌· ï쳌¡ ï쳌³ , L . B ï쳌² ï쳌¡ ï쳌¤ ï쳌¹ , C ï쳌¡ ï쳌² ï쳌² ï쳌© ï쳌º ï쳌¯ ï쳌³ ï쳌¡ S . ï?? ï?? ï?? ï?? . Prospecting for biodiversity : The search K . B ï쳌² ï쳌© ï쳌¤ ï쳌¢ ï쳌¯ ï쳌¡ ï쳌² ï쳌¤ , S . C ï쳌¯ ï쳌¬ ï쳌¬ ï쳌© ï쳌® ï쳌³ , G . C ï쳌² ï쳌¡ ï쳌§ ï쳌§ , J . E ï쳌¤ ï쳌· ï쳌¡ ï쳌² ï쳌¤ ï쳌³ , A . for legal and institutional frameworks . Ph.D . Dissertation , F ï쳌¡ ï쳌© ï쳌² ï쳌¦ ï쳌© ï쳌¥ ï쳌¬ ï쳌¤ , M . G ï쳌¯ ï쳌´ ï쳌´ ï쳌¬ ï쳌© ï쳌¥ ï쳌¢ , L.A . G ï쳌³ ï쳌£ ï쳌¨ ï쳌· ï쳌© ï쳌® ï쳌¤ , Y . H ï쳌¡ ï쳌¬ ï쳌¬ ï쳌¯ ï쳌£ ï쳌« , The University of Arizona , UMI Dissertation Services , A R . H ï쳌¡ ï쳌· ï쳌« ï쳌³ , R . H ï쳌¥ ï쳌§ ï쳌¹ ï쳌¥ ï쳌¬ ï쳌© , G . J ï쳌¯ ï쳌¨ ï쳌® ï쳌³ ï쳌¯ ï쳌® , G.T . K ï쳌¥ ï쳌µ ï쳌³ ï쳌£ ï쳌¨ , E.E . Bell & Howell Company . ï쳌µ ï쳌² ï쳌¬ : http : / / wwwlib.umi.com / L ï쳌¹ ï쳌¯ ï쳌® ï쳌³ , R . M ï쳌© ï쳌¬ ï쳌¬ ï쳌¥ ï쳌² , J . R ï쳌¯ ï쳌¤ ï쳌­ ï쳌¡ ï쳌® , J . R ï쳌¯ ï쳌³ ï쳌« ï쳌¯ ï쳌³ ï쳌« ï쳌© , and D . dissertations / fullcit / ï?? ï?? ï?? ï?? ï?? ï?? ï?? . S ï쳌© ï쳌¥ ï쳌§ ï쳌¥ ï쳌¬ - C ï쳌¡ ï쳌µ ï쳌³ ï쳌¥ ï쳌¹ . ï?? ï?? ï?? ï?? . Combining high risk science with C ï쳌² ï쳌¡ ï쳌§ ï쳌§ G.M . , M.R . B ï쳌¯ ï쳌¹ ï쳌¤ , M.R . G ï쳌² ï쳌¥ ï쳌¶ ï쳌¥ ï쳌² , and S.A . ambitious social and economic goals . Pharmaceutical S ï쳌£ ï쳌¨ ï쳌¥ ï쳌° ï쳌¡ ï쳌² ï쳌´ ï쳌º . ï?? ï?? ï?? ï?? . Policies for international collabora - Biology ï?? ï?? : ï?? â?? ï?? ï?? . tion and compensation in drug discovery and develop - S ï쳌© ï쳌´ ï쳌´ ï쳌¥ ï쳌® ï쳌¦ ï쳌¥ ï쳌¬ ï쳌¤ A . and R . G ï?¡ ï쳌­ ï쳌¥ ï쳌º ï?? ï?? ï?? ï?? . Biodiversity prospect - ment at the United States National Cancer Institute , The ing by ï쳌© ï쳌® ï쳌¢ io . p . ï?? ï?? â?? ï?? ï?? in W.V . R ï쳌¥ ï쳌© ï쳌¤ , S.A . L ï쳌¡ ï쳌© ï쳌² ï쳌¤ , C.A . ï쳌® ï쳌£ ï쳌© Letter of Collection . p . ï?? ï?? â?? ï?? ï?? in T . G ï쳌² ï쳌¥ ï쳌¡ ï쳌¶ ï쳌¥ ï쳌³ ( ed . ) M ï쳌¥ ï쳌¹ ï쳌¥ ï쳌² , R . G ï?¡ ï쳌­ ï쳌¥ ï쳌º , A . S ï쳌© ï쳌´ ï쳌´ ï쳌¥ ï쳌® ï쳌¦ ï쳌¥ ï쳌¬ ï쳌¤ , D.H . J ï쳌¡ ï쳌® ï쳌º ï쳌¥ ï쳌® , M.G . Intellectual property rights for indigenous peoples : G ï쳌¯ ï쳌¬ ï쳌¬ ï쳌© ï쳌® , and C . J ï쳌µ ï쳌­ ï쳌¡ ( eds . ) Biodiversity prospecting : A source book . Society for Applied Anthropology , Using genetic resources for sustainable development . Oklahoma City , ï쳌µ ï쳌³ ï쳌¡ . World Resources Institute , ï쳌µ ï쳌³ ï쳌¡ . G ï?¡ ï쳌­ ï쳌¥ ï쳌º R . , A . P ï쳌© ï쳌¶ ï쳌¡ , A . S ï쳌© ï쳌´ ï쳌´ ï쳌¥ ï쳌® ï쳌¦ ï쳌¥ ï쳌¬ ï쳌¤ , E . L ï쳌¥ ï?³ ï쳌® , J . J ï쳌© ï쳌­ ï?© ï쳌® ï쳌¥ ï쳌º , and G . M ï쳌© ï쳌² ï쳌¡ ï쳌¢ ï쳌¥ ï쳌¬ ï쳌¬ ï쳌© . ï?? ï?? ï?? ï?? . Costa Ricaâ??s Conservation Program T ï쳌© ï쳌­ ï쳌­ ï쳌¥ ï쳌² ï쳌­ ï쳌¡ ï쳌® ï쳌® B.N . , G . W ï?¤ ï쳌£ ï쳌¨ ï쳌´ ï쳌¥ ï쳌² , S . V ï쳌¡ ï쳌¬ ï쳌£ ï쳌© ï쳌£ , B . H ï쳌µ ï쳌´ ï쳌£ ï쳌¨ ï쳌© ï쳌® ï쳌³ ï쳌¯ ï쳌® , and National Biodiversity Institute ( ï쳌© ï쳌® ï쳌¢ io ) . p . ï?? ï?? â?? ï?? ï?? in C . C ï쳌¡ ï쳌³ ï쳌¬ ï쳌¥ ï쳌² , J . H ï쳌¥ ï쳌® ï쳌º ï쳌¥ ï쳌¬ , S . R ï쳌¡ ï쳌­ , F . C ï쳌µ ï쳌² ï쳌² ï쳌© ï쳌­ , R . M ï쳌¡ ï쳌® ï쳌¡ ï쳌« , W.V . R ï쳌¥ ï쳌© ï쳌¤ , S.A . L ï쳌¡ ï쳌© ï쳌² ï쳌¤ , C.A . M ï쳌¥ ï쳌¹ ï쳌¥ ï쳌² , R . G ï?¡ ï쳌­ ï쳌¥ ï쳌º , A . S . F ï쳌² ï쳌¡ ï쳌® ï쳌º ï쳌¢ ï쳌¬ ï쳌¡ ï쳌µ , W . M ï쳌¡ ï쳌© ï쳌¥ ï쳌³ ï쳌¥ , D . G ï쳌¡ ï쳌¬ ï쳌© ï쳌® ï쳌© ï쳌³ , E . S ï쳌µ ï쳌¡ ï쳌² ï쳌¥ ï쳌º , R . S ï쳌© ï쳌´ ï쳌´ ï쳌¥ ï쳌® ï쳌¦ ï쳌¥ ï쳌¬ ï쳌¤ , D.H . J ï쳌¡ ï쳌® ï쳌º ï쳌¥ ï쳌® , M.G . G ï쳌¯ ï쳌¬ ï쳌¬ ï쳌© ï쳌® , and C . J ï쳌µ ï쳌­ ï쳌¡ F ï쳌¯ ï쳌² ï쳌´ ï쳌µ ï쳌® ï쳌¡ ï쳌´ ï쳌¯ , E . S ï쳌¡ ï쳌¡ ï쳌¶ ï쳌¥ ï쳌¤ ï쳌² ï쳌¡ , R . B ï쳌¹ ï쳌¥ , R . M ï쳌¡ ï쳌´ ï쳌¡ , and G . ( eds . ) Biodiversity prospecting : Using genetic resources for M ï쳌¯ ï쳌® ï쳌´ ï쳌¥ ï쳌® ï쳌¥ ï쳌§ ï쳌² ï쳌¯ . ï?? ï?? ï?? ï?? . The Latin American ï쳌© ï쳌£ ï쳌¢ ï쳌§ : The first sustainable development . World Resources Institute , ï쳌µ ï쳌³ ï쳌¡ . five years . Pharmaceutical Biology ï?? ï?? : ï?? ï?? - ï?? ï?? . N ï쳌© ï쳌§ ï쳌¨ R . ï?? ï?? ï?? ï?? . Maya medicine in the biological gaze : Bioprospecting research as herbal fetishism . Current Anthropology ï?? ï?? : ï?? ï?? ï?? â?? ï?? ï?? ï?? . ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : I ï쳌­ ï쳌° ï쳌¬ ï쳌¥ ï쳌­ ï쳌¥ ï쳌® ï쳌´ ï쳌¡ ï쳌´ ï쳌© ï쳌¯ ï쳌® P ï쳌¡ ï쳌´ ï쳌¨ ï쳌· ï쳌¡ ï쳌¹ ï쳌³ Endnotes 1 In the ï쳌µ ï쳌³ ï쳌¡ , ï쳌® ï쳌° ï쳌³ regulations are analogous to some of the provisions are international partnerships composed of universities , NGOs , of ï쳌¡ ï쳌¢ ï쳌³ laws and policies that other countries have proposed and these pharmaceutical companies , and other organizations from the ï쳌µ ï쳌³ ï쳌¡ ï쳌® ï쳌° ï쳌³ regulations facilitate ï쳌¡ ï쳌¢ ï쳌³ goals in ï쳌® ï쳌° ï쳌³ lands ( see Chapter ï?? ) . and the countries that provide the genetic resources , and in some 2 cases , traditional knowledge . The first five - year phase of the pro - Consistent with our use in Chapters ï?? and ï?? , we define bioprospect - gram started in ï?? ï?? ï?? ï?? and ï?? ï?? ï?? ï?? with five groups . In ï?? ï?? ï?? ï?? , three new ing as the search for plants , animals , and microbial species for groups won awards and three of the previous groups were renewed academic , pharmaceutical , biotechnological , agricultural , and for a second five - year period until ï?? ï?? ï?? ï?? . One of the new proj - industrial purposes . ects , the Maya ï쳌© ï쳌£ ï쳌¢ ï쳌§ was terminated in ï?? ï?? ï?? ï?? ( see this chapter and 3 National ï쳌¡ ï쳌¢ ï쳌³ laws and policies have approved ï?? ï?? projects in Costa Chapter ï?? ) . In December ï?? ï?? ï?? ï?? , the new round of awards supported Rica , three in Mexico , two in the Philippines , one in Samoa , and five - year - long projects for five groups ( three of these were renew - one in the ï쳌µ ï쳌³ ï쳌¡ . It must be noted that this account does not include als ) and two - year planning grants for seven groups ( R ï쳌¯ ï쳌³ ï쳌¥ ï쳌® ï쳌´ ï쳌¨ ï쳌¡ ï쳌¬ et projects that have been negotiated following a contractual approach al . ï?? ï?? ï?? ï?? , http : / / www.nih.gov / news / pr / dec ï?? ï?? ï?? ï?? / fic - ï?? ï?? . htm ) . in countries that lack national ï쳌¡ ï쳌¢ ï쳌³ laws or policies such as Chile , 6 Laos , and Vietnam . In November ï?? ï?? ï?? ï?? , the Environment Organic Law defined a more 4 specific range of activities for ï쳌­ ï쳌© ï쳌² ï쳌¥ ï쳌® ï쳌¥ ï쳌­ regarding the field of natu - Recently , however , several countries , such as Panama and ral resources and ï쳌­ ï쳌© ï쳌² ï쳌¥ ï쳌® ï쳌¥ ï쳌­ became the Ministry of Environment Indonesia , have found guidance in the Bonn Guidelines on Access and Energy ( ï쳌­ ï쳌© ï쳌® ï쳌¡ ï쳌¥ ) . to Genetic Resources and Fair and Equitable Sharing of the Benefits Arising out of their Utilization ( see Chapter ï?? ) . These 7 The ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ has been used as a vehicle to promote ï쳌¡ ï쳌¢ ï쳌³ goals in guidelines were adopted by the Sixth Conference of the Parties to other bioprospecting projects . For example , in ï?? ï?? ï?? ï?? a ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ was the ï쳌£ ï쳌¢ ï쳌¤ in April ï?? ï?? ï?? ï?? . used by one of the ï쳌© ï쳌£ ï쳌¢ ï쳌§ s to facilitate the negotiation of benefit - 5 The ï쳌© ï쳌£ ï쳌¢ ï쳌§ s are an international bioprospecting approach initiated sharing provisions between the Walter Reed Army Institute of in ï?? ï?? ï?? ï?? and financed by the ï쳌µ ï쳌³ ï쳌¡ National Institutes of Health , Research and other public and private organizations ( C ï쳌¡ ï쳌² ï쳌² ï쳌© ï쳌º ï쳌¯ ï쳌³ ï쳌¡ National Science Foundation , and Department of Agriculture that is ï?? ï?? ï?? ï?? ) . guided by the following objectives : ï?? ) to uncover new knowledge 8 This purpose applies to use of wild flora and fauna specimens in that will lead to improved therapies ; ï?? ) to enhance scientific capac - economic activities that involve their controlled reproduction or ity building in developing countries ; and ï?? ) to ensure sustained captivity and semi - captivity management . economic growth and the conservation of genetic resources in the countries where collections of organisms are made . These groups ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ Table ï?? . Bioprospecting in Pacific Rim countries . This table provides information about all bioprospecting projects approved under national access and benefit - sharing ( ï쳌¡ ï쳌¢ ï쳌³ ) laws and policies until January ï?? ï?? ï?? ï?? . However , not all bioprospecting projects implemented outside the scope of these laws and policies or in countries without ï쳌¡ ï쳌¢ ï쳌³ laws and policies are listed here . ( Morinda citrifolia ) , a tree with medicinal properties , to the A . Countries with ABS laws and policies ï쳌µ ï쳌³ ï쳌¡ . In ï?? ï?? ï?? ï?? the administrative directive entitled â?? Conditions ï?? . Colombia for access to and benefit sharing of Samoaâ??s biodiversity re - Decision ï?? ï?? ï?? has been in place since ï?? ï?? ï?? ï?? and until February sources â?쳌 was invoked to negotiate a benefit - sharing agreement ï?? ï?? ï?? ï?? not a single access contract has been approved under it . between the government of Samoa and the ï쳌¡ ï쳌© ï쳌¤ ï쳌³ Research Also , the number of access applications has been extremely Alliance for the use of a compound called prostratin derived low . Between ï?? ï?? ï?? ï?? and ï?? ï?? ï?? ï?? the Ministry for the Environment from the mamala plant ( Homalanthus nutans ) . This compound received ï?? ï?? access applications . One of them was denied and may be used together with other drugs for the treatment of the rest are on hold ( see Chapter ï?? ) . The New York Botanical ï쳌¡ ï쳌© ï쳌¤ ï쳌³ . In late ï?? ï?? ï?? ï?? , the ï쳌µ ï쳌³ ï쳌¡ ï쳌© ï쳌£ ï쳌¢ ï쳌§ program approved a planning Garden , the University of Antioquia , University of Medellin , grant for a project coordinated by the ï쳌µ ï쳌³ ï쳌¡ National Tropical and the Botanical Garden Juan Marin Cespedos of Tulua col - Botanical Garden in Hawaii in collaboration with the Samoan lected biological samples for the ï쳌µ ï쳌³ ï쳌¡ National Cancer Institute Ministry of Trade and Tourism and other organizations . It is ( ï쳌® ï쳌£ ï쳌© ) before Decision ï?? ï?? ï?? became national law . uncertain what legal ï쳌¡ ï쳌¢ ï쳌³ framework will apply to this project ï?? . Costa Rica as Samoa is currently developing an ï쳌¡ ï쳌¢ ï쳌³ framework . The ï?? ï?? ï?? ï?? Law of Biodiversity is not operational yet . Access ï?? . Thailand applications involving bioprospecting have been approved So far no projects have been approved under the new access under the ï?? ï?? ï?? ï?? Law of Wildlife Conservation No . ï?? ï?? ï?? ï?? ( and framework because the government is still developing lower its ï?? ï?? ï?? ï?? regulation ) and in accordance with a cooperation level regulations to facilitate the implementation of ï쳌¡ ï쳌¢ ï쳌³ laws . agreement between the National Biodiversity Institute ( ï쳌© ï쳌® ï쳌¢ io ) However , the University of Illinois at Chicago in collabora - and the Ministry of the Environment and Energy . Since ï?? ï?? ï?? ï?? , tion with the Thailand Forest Herbarium has collected plant ï?? ï?? bioprospecting projects have been granted access ( see samples for the ï쳌µ ï쳌³ ï쳌¡ ï쳌® ï쳌£ ï쳌© . In the ï?? ï?? ï?? ï?? s , Chris Deren of the Chapter ï?? ) . In December ï?? ï?? ï?? ï?? , the ï쳌µ ï쳌³ ï쳌¡ - based International University of Florida announced plans to develop a ï쳌µ ï쳌³ ï쳌¡ ver - Cooperative Biodiversity Group ( ï쳌© ï쳌£ ï쳌¢ ï쳌§ ) program approved a sion of Thailandâ??s Jasmine rice . Germplasm for this experi - planning grant for a new project that will be implemented by ment was obtained from the Philippines - based International Harvard University and ï쳌© ï쳌® ï쳌¢ io . This project will be negotiated Rice Research Institute through the ï쳌µ ï쳌³ ï쳌¡ Department of under the ï?? ï?? ï?? ï?? Law of Biodiversity framework . Agriculture . In ï?? ï?? ï?? ï?? Sankyo of Japan extracted the active ï?? . Ecuador ingredient ( plaonotol ) of the tree plaonoi ( Croton sublyratus ) No bioprospecting projects have been negotiated under to produce Kelnac , a tablet to treat ulcers . Decision ï?? ï?? ï?? . ï?? . United States of America ( ï쳌µ ï쳌³ ï쳌¡ ) ï?? . Mexico The owner of the land ( public or private ) where the genetic Three bioprospecting projects were granted access under the resource is found defines access and benefit - sharing issues . So , Ecological Equilibrium and Environmental Protection General far the most public and documented bioprospecting initiative Act . These are : ï?? ) The ï쳌µ ï쳌³ ï쳌¡ Maya ï쳌© ï쳌£ ï쳌¢ ï쳌§ , ï?? ) The Latin American negotiated under federal regulations that are analogous to ï쳌¡ ï쳌¢ ï쳌³ ï쳌© ï쳌£ ï쳌¢ ï쳌§ , and ï?? ) the Diversa / National Autonomous University policies is the agreement signed between Yellowstone National project . However , these projects were terminated due to social Park and the pharmaceutical company Diversa Corporation protest and legal inconsistencies ( see Chapter ï?? ) . ( see Chapter ï?? ) . In ï?? ï?? ï?? ï?? , Diversa also signed an agreement ï?? . Philippines with the ï쳌µ ï쳌³ ï쳌¡ - based Arctos Pharmaceuticals , Inc . giving Two out of ï?? ï?? proposed bioprospecting projects have been Diversa rights to bioprospect in Alaska and neighboring ter - granted access under Executive Order ï?? ï?? ï?? . The University of ritories . Through this agreement , Diversa obtains access to ge - Utah / University of the Philippines project , and the University netic resources found in habitats covered by agreements Arctos of the Philippines system project . In late ï?? ï?? ï?? ï?? , the ï쳌µ ï쳌³ ï쳌¡ ï쳌© ï쳌£ ï쳌¢ ï쳌§ has signed with Alaskan landholding native corporations , program approved a planning grant for a project coordinated individuals and other entities . In ï?? ï?? ï?? ï?? , Diversa announced the by the ï쳌µ ï쳌³ ï쳌¡ Michigan State University in collaboration with signing of an access and benefit - sharing agreement with the the University of the Philippines and local indigenous com - Marine Bioproducts Engineering Center at the University of munities . This project will be granted access under the ï?? ï?? ï?? ï?? Hawaii in Honolulu . This agreement gives Diversa the right to Wildlife Resources and Conservation Act ( see Chapter ï?? ) . study genes from existing collections and from environmental samples collected by the Hawaiian center . Pfizer has screened ï?? . Peru medicinal plants provided by the New York Botanical Garden No bioprospecting project has been negotiated under Decision and Phytera has carried out bioprospecting activities in Hawaii ï?? ï?? ï?? . Between ï?? ï?? ï?? ï?? and ï?? ï?? ï?? ï?? the ï쳌µ ï쳌³ ï쳌¡ ï쳌© ï쳌£ ï쳌¢ ï쳌§ program provided and the Virgin Islands . funding for bioprospecting activities in Peru . This project was coordinated by Washington University in collaboration B . Countries working towards the development of ABS with the Museum of Natural History and other organizations . laws and policies The New York Botanical Garden , in collaboration with the Research Institute of the Peruvian Amazon Region , collected ï?? . Australia samples for the ï쳌µ ï쳌³ ï쳌¡ ï쳌® ï쳌£ ï쳌© before Decision ï?? ï?? ï?? came into force . There is a long history of benefit - sharing agreements negotiated by bioprospectors in Australia . These include ï?? . Samoa In ï?? ï?? ï?? ï?? , Nonu Samoa Enterprises began export of nonu AstraZeneca R & D and Griffith University ; the ï쳌µ ï쳌³ ï쳌¡ ï쳌® ï쳌£ ï쳌© and the ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : I ï쳌­ ï쳌° ï쳌¬ ï쳌¥ ï쳌­ ï쳌¥ ï쳌® ï쳌´ ï쳌¡ ï쳌´ ï쳌© ï쳌¯ ï쳌® P ï쳌¡ ï쳌´ ï쳌¨ ï쳌· ï쳌¡ ï쳌¹ ï쳌³ Table ï?? . Continued Australian Institute of Marine Science ; Cerylid Biosciences have enjoyed the benefits of this plant for generations and its consumption remains strong casting doubts over the Ltd . and Royal Botanic Gardens ; and BioProspect Ltd . and alleged detrimental health effects . American Home Products the Department of Conservation and Land Management of also holds a patent on a Fijian sponge that has anti - tumor Western Australia ( see Chapter ï?? ) . properties . In late ï?? ï?? ï?? ï?? , the ï쳌µ ï쳌³ ï쳌¡ ï쳌© ï쳌£ ï쳌¢ ï쳌§ program approved a ï?? . Cambodia planning grant for a project coordinated by the ï쳌µ ï쳌³ ï쳌¡ Georgia ï쳌® / ï쳌¡ Institute of Technology in collaboration with the University of ï?? . Canada South Pacific and other organizations . Several bioprospecting projects have been implemented in the ï?? . Guatemala last few years in Canada . Researchers from universities such Local universities and research centers carry out several as the University of British Columbia and private companies bioprospecting projects . But there is no information available such as Accutec Technologies ( Vancouver , British Columbia ) , about them . Semgen ( St . Nicolas , Québec ) , and Ecopia Biosciences ï?? ï?? . Honduras ( Montréal , Québec ) have carried out bioprospecting activities There are no more than three projects involving local in marine and terrestrial environments . Cubist Pharmaceuticals universities . But there is no information available about them . is also bioprospecting in Western Canada . ï?? ï?? . Indonesia ï?? . Chile The ï쳌µ ï쳌³ ï쳌¡ - based pharmaceutical company Diversa Some of the bioprospecting projects implemented in this Corporation and Bogor University have been implementing a country include a ï쳌µ ï쳌³ ï쳌¡ ï쳌© ï쳌£ ï쳌¢ ï쳌§ project ( ï?? ï?? ï?? ï?? â?? ï?? ï?? ï?? ï?? ) coordinated bioprospecting project since ï?? ï?? ï?? ï?? . The project was renewed by the ï쳌µ ï쳌³ ï쳌¡ University of Arizona in collaboration with in ï?? ï?? ï?? ï?? . Also , the ï쳌µ ï쳌³ ï쳌¡ ï쳌® ï쳌£ ï쳌© has screened samples of marine Catholic University of Chile and other organizations ; the and terrestrial organisms that have been collected by the Coral Institute for Agriculture Investigation ( ï쳌© ï쳌® ï쳌© ï쳌¡ ) and the Royal Reef Research Foundation , the University of Illinois , the Botanical Gardens , Kew bioprospecting project ; and the Indonesia Herbarium Bogoriense , and the Indonesian Institute ï쳌© ï쳌® ï쳌© ï쳌¡ and C.M . Rick Tomato Genetics Resource Center of the of Science . University of California , Davis ( see Chapter ï?? ï?? ) . ï?? ï?? . Japan ï?? . China Multiple Japanese biotechnology companies are engaged in Chinaâ??s extensive information about medicinal plants has many bioprospecting projects in Japan . However , there is no been examined by many bioprospectors . These include information available about these initiatives . American Biosciences , the ï쳌µ ï쳌³ ï쳌¡ National Institutes of Health and New York University that have patents on several ï?? ï?? . Malaysia Chinese medicinal species . Also , the ï쳌µ ï쳌³ ï쳌¡ ï쳌® ï쳌£ ï쳌© has screened In the late ï?? ï?? ï?? ï?? s and early ï?? ï?? ï?? ï?? s , the ï쳌µ ï쳌³ ï쳌¡ ï쳌® ï쳌£ ï쳌© discovered that plants collected in collaboration with the Kunming Institute two naturally occurring compounds ( Calanolide A and B ) of Botany . Pfizer is also relying exclusively on traditional were effective against ï쳌¨ ï쳌© ï쳌¶ . In ï?? ï?? ï?? ï?? , this discovery led to the medical practices to identify potential pharmaceuticals . establishment of a joint venture between the State Government of Sarawak and MediChem Research to develop and market ï?? . Cook Islands Calanolide A as an anti - ï쳌¨ ï쳌© ï쳌¶ medicine . In ï?? ï?? ï?? ï?? , MediChemâ??s Current bioprospecting initiatives include projects related share in the company was transferred to Advanced Life to pharmaceutical research for marine products , marine Sciences , Inc . Other bioprospecting initiatives include : ï?? ) toxins , whale research , and marine / terrestrial flora and fauna the Universiti Kebangsaan Malaysia that tested ï?? ï?? samples taxonomy ( national heritage project ) . of marine sponges on human tumor cell lines in cytotoxic ï?? . El Salvador tests , and found ï?? ï?? samples to be toxic to the tumors and ï?? ) Some local universities and research centers extract chemical the Universiti Sains Malaysia that tested sea cucumbers for compounds from plants for pharmaceutical purposes . No bioactive compounds ( see Chapter ï?? ï?? ) . major findings have been reported . ï?? ï?? . Marshall Islands ï?? . Fiji No bioprospecting projects are currently being implemented in The most documented bioprospecting agreement in Fiji is the Marshall Islands . However , in the past , the Palauan - based the one established between the University of South Pacific Coral Reef Research Foundation has collected samples of and the Strathclyde Institute of Drug Research in Scotland . marine organisms for the ï쳌µ ï쳌³ ï쳌¡ ï쳌® ï쳌£ ï쳌© . Biological samples were collected in collaboration with the ï?? ï?? . Micronesia Verata community . The community was not a partner to the The Coral Reef Research Foundation has collected samples of main agreement , but ï쳌¡ ï쳌¢ ï쳌³ was provided in a separate agreement marine organisms for the ï쳌µ ï쳌³ ï쳌¡ ï쳌® ï쳌£ ï쳌© . signed between the university and the community . Kava ( Piper methysticum ) , a medicinal plant native to the South ï?? ï?? . New Zealand Pacific region was traded and used widely before the ï쳌£ ï쳌¢ ï쳌¤ was The Coral Reef Research Foundation has collected samples adopted . The cultivation of the plant has brought economic of marine organisms for the ï쳌µ ï쳌³ ï쳌¡ ï쳌® ï쳌£ ï쳌© . The University of benefits to Fiji and many other South Pacific countries . Canterbury ( Christchurch ) has also collaborated in the Kava extracts and active compounds have been patented by collection of biological samples for ï쳌® ï쳌£ ï쳌© . The University also companies in Europe and the ï쳌µ ï쳌³ ï쳌¡ . However , no royalties has collaborative links with the Danish Technical University have flowed to Pacific Island countries . In any case , the Kava and the School of Pharmacy , University of London , among market has declined in recent years in Europe and the ï쳌µ ï쳌³ ï쳌¡ due others . Other local companies such as Global Technologies , to allegations that the plant causes liver damage . However , and Biodiscovery New Zealand look for bioactive compounds it should be noted that Fiji and other Pacific Island countries from deer / sheep and bacteria respectively . Tairawhiti ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ Table ï?? . Continued Pharmaceuticals extracts manuka and kanuka oils . Phytomed ï쳌µ ï쳌³ ï쳌¡ Department of Energyâ??s Idaho National Engineering and Environmental Laboratory to obtain samples from Russian Medicinal Herbs manufactures and supplies plant extracts habitats . and dried herbs to health practitioners and other herbal manufacturers . ï?? ï?? . Singapore ï쳌® / ï쳌¡ ï?? ï?? . Nicaragua ï쳌® / ï쳌¡ ï?? ï?? . Solomon Islands In the ï?? ï?? ï?? ï?? s , marine collections were made for cancer ï?? ï?? . Niue research ( pharmaceuticals ) . In the early ï?? ï?? ï?? ï?? s , the University In ï?? ï?? ï?? ï?? , the Ministry of Tourism signed an agreement with the of California made plant collections for pharmaceutical Zoological Parks Board of New South Wales based in Sydney , purposes . Collections of taro are being carried out by ï쳌³ ï쳌° ï쳌£ . Australia . Under the agreement , three sea snakes ( Laticauda In the early ï?? ï?? ï?? ï?? s , a human sample resulted in a patent schistorynchus ) were given to the Taronga Zoo for display application in the ï쳌µ ï쳌³ ï쳌¡ . The Research Committee denied purposes only . The agreements states that the sea snakeâ??s two access applications of the Coral Reef Foundation that venom , skin , or any other genetic component will be protected was planning to collect samples for the ï쳌µ ï쳌³ ï쳌¡ ï쳌® ï쳌£ ï쳌© . The Lauru during display and that no genetic material will be extracted Land Conference and communities opposed plant collection from the sea snakes for scientific research or any other made by the University of Hawaii in Choiseul province for purpose . In ï?? ï?? ï?? ï?? , a project of the South Pacific Commission pharmaceuticals and other industrial purposes . Applications ( ï쳌³ ï쳌° ï쳌£ ) collected samples of ï?? ï?? varieties of taro ( a root crop and for native orchid exports by nationals have been turned down . staple of the Pacific diet ) . Kava has been collected in the ï?? ï?? ï?? ï?? s and ï?? ï?? ï?? ï?? s and exported ï?? ï?? . Panama worldwide . In recent years this country has used a contractual approach to ï?? ï?? . Vanuatu facilitate bioprospecting activities and this strategy has been The Coral Reef Research Foundation has collected samples of supported by legislation that regulates the collection of natural marine organisms for the ï쳌µ ï쳌³ ï쳌¡ ï쳌® ï쳌£ ï쳌© . Kava has been collected in resources . Since ï?? ï?? ï?? ï?? a ï쳌µ ï쳌³ ï쳌¡ ï쳌© ï쳌£ ï쳌¢ ï쳌§ project has been carrying the ï?? ï?? ï?? ï?? s and ï?? ï?? ï?? ï?? s and exported worldwide . out bioprospecting activities in Panama and funding for this ï?? ï?? . Vietnam project was renewed in late ï?? ï?? ï?? ï?? for five additional years . This The ï쳌µ ï쳌³ ï쳌¡ ï쳌© ï쳌£ ï쳌¢ ï쳌§ project of Vietnam has been carrying out project is coordinated by the Smithsonian Tropical Research bioprospecting activities since ï?? ï?? ï?? ï?? and its funding was Institute in collaboration with the National Secretariat for renewed in late ï?? ï?? ï?? ï?? . This project is coordinated by the ï쳌µ ï쳌³ ï쳌¡ Science , Technology , and Innovation and other organizations . University of Illinois at Chicago in collaboration with the Local academic and research centers also have carried out Vietnam National Center for Natural Sciences and Technology bioprospecting projects . and other organizations . ï?? ï?? . Papua New Guinea In late ï?? ï?? ï?? ï?? , the ï쳌µ ï쳌³ ï쳌¡ ï쳌© ï쳌£ ï쳌¢ ï쳌§ program approved funding for a C . Countries not involved in any process leading to the five - year project coordinated by the ï쳌µ ï쳌³ ï쳌¡ University of Utah development of ABS laws and policies in collaboration with the University of Papua New Guinea ï?? . Kiribati and other organizations . The Australian National University Taro varieties have been collected by a project of ï쳌³ ï쳌° ï쳌£ . and the Tillegerry Habitat Association , New South Wales , Australia have implemented projects in coordination with ï?? . Laos the Australian - based Cerylid Biosciences Ltd and the Kelam The ï쳌µ ï쳌³ ï쳌¡ ï쳌© ï쳌£ ï쳌¢ ï쳌§ of Laos has been bioprospecting since ï?? ï?? ï?? ï?? and its funding was renewed in late ï?? ï?? ï?? ï?? . This project is People of the Kaironk Valley in Papua New Guinea . Also , coordinated by the ï쳌µ ï쳌³ ï쳌¡ University of Illinois at Chicago and the Palauan - base Coral Reef Research Foundation and the includes the participation of several local organizations . University of Illinois have collected samples of marine and terrestrial organisms for the ï쳌µ ï쳌³ ï쳌¡ ï쳌® ï쳌£ ï쳌© in collaboration with ï?? . Nauru the Papua New Guinea Forest Research Institute , the Lae ï쳌® / ï쳌¡ Herbarium , and the Papua New Guinea Department of the ï?? . Palau Environment and Conservation , Boroko . Sponges growing on The Coral Reef Research Foundation has collected samples of a coral reef off the coast of Papua New Guinea are the source marine organisms for the ï쳌µ ï쳌³ ï쳌¡ ï쳌® ï쳌£ ï쳌© . of a powerful antifungal compound papuamine . The sponges ï?? . Tonga yield only minute quantities of the compound . Therefore , The Coral Reef Research Foundation has collected samples of Myco Pharmaceuticals ( ï쳌µ ï쳌³ ï쳌¡ ) is now attempting to synthesize marine organisms for the ï쳌µ ï쳌³ ï쳌¡ ï쳌® ï쳌£ ï쳌© . In late ï?? ï?? ï?? ï?? , the ï쳌µ ï쳌³ ï쳌¡ ï쳌© ï쳌£ ï쳌¢ ï쳌§ papuamine in the laboratory . program approved a planning grant for a project coordinated ï?? ï?? . Republic of Korea by the ï쳌µ ï쳌³ ï쳌¡ National Tropical Botanical Garden in Hawaii ï쳌® / ï쳌¡ in collaboration with the Tonga Ministry of Agriculture and Forestry and other organizations . ï?? ï?? . Russian Federation In ï?? ï?? ï?? ï?? the ï쳌µ ï쳌³ ï쳌¡ - based Diversa Corporation signed a ï?? . Tuvalu biodiversity access agreement giving the company rights to The Coral Reef Research Foundation has collected samples obtain , identify , and commercialize genes collected in unique of marine organisms for the ï쳌µ ï쳌³ ï쳌¡ ï쳌® ï쳌£ ï쳌© . Taro varieties are been Russian habitats . Diverse will work with Russia through the collected by a project of ï쳌³ ï쳌° ï쳌£ . ï?? ï?? 4 Colombia : Access and Exchange of Genetic Resources Paola Ferreira - Miani Colombia is characterized by high levels of biodiversity species of orchids that represent approximately ï?? ï?? % of and endemism ( C ï쳌¨ ï쳌¡ ï쳌¶ ï쳌¥ ï쳌³ and A ï쳌² ï쳌¡ ï쳌® ï쳌§ ï쳌¯ ï?? ï?? ï?? ï?? , ï쳌¤ ï쳌® ï쳌° ï?? ï?? ï?? ï?? ) . the worldâ??s total . Other extremely diverse plant families Colombia has a land surface of ï?? ï?? ï?? , ï?? ï?? ï?? , ï?? ï?? ï?? ha , which are Araceae , with one sixth of the worldâ??s known spe - constitutes approximately ï?? . ï?? % of the earthâ??s continental cies ; Heliconiaceae with approximately ï?? ï?? species ; and area . This area contains ï?? ï?? % of the worldâ??s biodiversity . Ericaceae with ï?? ï?? ï?? species . Studies in the Caribbean This is why Colombia is considered among the megadi - region regarding seaweeds have shown it is one of the verse countries of the world . richest areas of the Atlantic Coast with approximately ï?? ï?? ï?? Of the land surface of Colombia , ï?? ï?? . ï?? million ha species . The Pacific coast has a lower diversity with ï?? ï?? ï?? are covered by natural forests : ï?? ï?? . ï?? million ha by other identified species of seaweeds . types of vegetation which include savanna , arid areas , Regarding vertebrates ( excepting fish ) , Colombia holds and wetlands ; ï?? . ï?? million ha by continental water , snow third place with ï?? , ï?? ï?? ï?? species ( Table ï?? ) . Richness in mam - peaks , and human settlements ; and at least ï?? ï?? . ï?? million mals , and in particular bats ( ï?? ï?? ï?? species ) and rodents ( ï?? ï?? ha are under agricultural use and colonization processes . species ) is noteworthy . There are ï?? ï?? primate species , which These general categories of land cover and use host the represent one third of those found in tropical America , ecosystem diversity typical of Colombia . The richness in surpassed only by Brazil , which has ï?? ï?? primate species . ecosystem types has been attributed to a variety of factors Colombia is commonly classified as the country with the including the following : the countryâ??s localization between largest number of birds . It contains ï?? ï?? % of all identified the two tropics , the variety of soil and climatic conditions South American birds and approximately ï?? ï?? of these spe - that results in a wide array of geographic spaces , and the cies are endemic to Colombia . Information on fish diversity existence of areas that have been geographically isolated . is extremely scarce and large areas of the country have not The countryâ??s ecosystem diversity is of such importance that only a few of the worldâ??s ecosystems are not repre - Table ï?? . Number of vertebrate species ( excluding fish ) in sented in Colombia . Colombia compared to the number described worldwide Ecosystem diversity is related to species diversity , Proportion in which is the most common way to refer to biodiversity . Group Colombia World Colombia ( % ) It represents the number of species in any given area . Mammals ï?? ï?? ï?? ï?? , ï?? ï?? ï?? ï?? . ï?? Approximately ï?? ï?? , ï?? ï?? ï?? vascular plants are known to be Birds ï?? , ï?? ï?? ï?? ï?? , ï?? ï?? ï?? ï?? ï?? . ï?? present in Colombia , a large number for the size of the Reptiles ï?? ï?? ï?? ï?? , ï?? ï?? ï?? ï?? . ï?? country , especially considering that all Africa south of the Amphibian ï?? ï?? ï?? ï?? , ï?? ï?? ï?? ï?? ï?? . ï?? Sahara contains in total ï?? ï?? , ï?? ï?? ï?? species , and that Brazil , Total ï?? , ï?? ï?? ï?? ï?? ï?? , ï?? ï?? ï?? ï?? ï?? . ï?? which has a surface ï?? . ï?? times larger , has ï?? ï?? , ï?? ï?? ï?? species Source : ï쳌© ï쳌¡ v ï쳌¨ ï쳌° ï쳌® ï쳌µ ï쳌­ ï쳌¡ inédito , cited in F ï쳌¡ ï쳌® ï쳌¤ ï쳌© ï?± ï쳌¯ and F ï쳌¥ ï쳌² ï쳌² ï쳌¥ ï쳌© ï쳌² ï쳌¡ ( ï?? ï?? ï?? ï?? ) . of vascular plants . Colombia has between ï?? , ï?? ï?? ï?? and ï?? , ï?? ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ been surveyed . Along the Caribbean coast , species rich - and to create opportunities for access activities , negotiated ness in coral reefs is particularly noticeable , with ï?? ï?? ï?? and approved legislation on access to genetic resources species identified out of an estimated total of ï?? ï?? ï?? marine covering the five nations . As a result of this process , species . Surveys have been less complete on the Pacific Colombia is now a participant in an Andean regional pol - coast . Insects are also particularly relevant because of their icy governing access to genetic resources and derivatives : endemism and rarity . â?? Decision ï?? ï?? ï?? of the Cartagena Agreement â?쳌 or â?? Common Biodiversity , and in particular genetic diversity , has Regime on Access to Genetic Resources â?쳌 . This legislation been considered a potential source of wealth for the coun - constitutes the main legal framework regarding access to try . As a party to the Convention on Biological Diversity genetic resources in Colombia . ( ï쳌£ ï쳌¢ ï쳌¤ ) , Colombia has the responsibility of setting the con - It is important to understand this legislation in the con - ditions for giving access to its genetic resources to other text of Colombiaâ??s biological diversity and the larger pic - parties , upon mutually agreed terms , while respecting the ture of the countryâ??s biodiversity policy . The threats to the sovereign rights of the state over these resources . countryâ??s biodiversity are also very real ( Box ï?? ) . Following Colombia and the other countries of the Andean is a section regarding the countryâ??s policy principles and 1 Community , motivated by factors such as the need to goals that are relevant for understanding the access and comply with the ï쳌£ ï쳌¢ ï쳌¤ , to support by regional integration , benefit - sharing ( ï쳌¡ ï쳌¢ ï쳌³ ) policy framework . National Biodiversity Policy candtion National Biodiversity Strategy and A Plan Colombia , as a party to the ï쳌£ ï쳌¢ ï쳌¤ , has been committed to upon fashion with the community . conservation and sustainable use of its biological resources . ï?? . The importance of the protection of individual and Therefore , in ï?? ï?? ï?? ï?? the Colombian Government approved a collective property rights is recognized . National Biodiversity Policy ( ï쳌® ï쳌¢ ï쳌° ) which determined the ï?? . The conservation and sustainable use of biodiver - countryâ??s policy priorities for the future ( ï쳌¤ ï쳌® ï쳌° ï?? ï?? ï?? ï?? ) . The sity must be addressed globally . It thus requires policy has three major goals : international commitment between nations . â?¢ Conservation of the components of biodiversity ; ï?? . The conservation and sustainable use of biodiversity requires a cross - sectoral approach and must be ad - â?¢ Greater knowledge of biodiversity ; and dressed in a decentralized manner , including the par - â?¢ The promotion of sustainable use of biodiversity ticipation of all levels of government and society . and the equal distribution of benefits of that use . ï?? . The precautionary principle must employed , These three goals were further developed in ten strat - especially with respect to genetic erosion and egies . The guidelines for the development of the policy biosafety . were approved by the National Environmental Council , The ï쳌® ï쳌¢ ï쳌° proposes the following ten strategies , aligned which is the highest advisory authority to the Ministry of with the three basic goals described earlier ( F ï쳌¡ ï쳌® ï쳌¤ ï쳌© ï?± ï쳌¯ and Environment ( ï쳌­ ï쳌¯ ï쳌¥ ) . These initial guidelines were further F ï쳌¥ ï쳌² ï쳌² ï쳌¥ ï쳌© ï쳌² ï쳌¡ ï?? ï?? ï?? ï?? ) : developed by the Instituto de Investigación en Recursos 2 â?¢ Distribute the benefits derived from biodiversity Biológicos â?? Alexander von Humboldt â?쳌 , ( Research equitably . Institute on Biological Resources ) , the National Planning 3 Department ( ï쳌¤ ï쳌® ï쳌° ) , and the ï쳌­ ï쳌¯ ï쳌¥ . Knowledge The ï쳌® ï쳌¢ ï쳌° set forth eight principles that are relevant for â?¢ Characterize the components of biological diversity . its interpretation and orientation ( ï쳌¤ ï쳌® ï쳌° ï?? ï?? ï?? ï?? ) : â?¢ Recover , protect , and publicize traditional knowl - ï?? . Biodiversity is a national patrimony and has a edge . strategic value for the nationâ??s current and future Conservation development . ï?? . Biological diversity has tangible components at the â?¢ Develop and consolidate the National System of level of molecules , genes and populations , species Natural Protected Areas . and communities , and ecosystems and landscapes . â?¢ Reduce the processes that deteriorate biodiversity . There are also intangible components that include â?¢ Restore ecosystems and species . knowledge , innovation , and associated cultural â?¢ Promote ex situ conservation . practices . Use ï?? . Biodiversity has a dynamic character both in space â?¢ Promote sustainable management systems of re - and time , and its components and evolutionary pro - newable natural resources . cesses must be preserved . â?¢ Promote sustainable development of the economic ï?? . The benefits derived from its use must be distributed in a fair and equitable manner and in an agreed - potential of biodiversity . ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : C ï쳌¯ ï쳌¬ ï쳌¯ ï쳌­ ï쳌¢ ï쳌© ï쳌¡ tion . Therefore , in ï?? ï?? ï?? ï?? the ï쳌­ ï쳌¯ ï쳌¥ of Colombia formulated â?¢ Develop economic valuation systems of biodiver - sity components . a project to finance such an endeavor and received a grant from the United Nations Environmental Program ( ï쳌µ ï쳌® ï쳌¥ ï쳌° ) Since the ï쳌® ï쳌¢ ï쳌° proposes a set of strategies meant to to develop the National Biodiversity Strategy and Action provide a long term view of Colombiaâ??s policy objec - Plan ( ï쳌® ï쳌¢ ï쳌³ ï쳌¡ ï쳌° ) . This project was initially comprised of two tives regarding biodiversity , it was necessary to develop stages . In the first stage , a technical proposal of the ï쳌® ï쳌¢ ï쳌³ ï쳌¡ ï쳌° a strategy to implement them . This strategy should de - was developed . This task was assigned to the Humboldt termine specific goals and objectives to be reached and identify those who should be involved in its implementa - Institute and the ï쳌¤ ï쳌® ï쳌° , with the collaboration of the ï쳌­ ï쳌¯ ï쳌¥ . Box 1 . Causes of Biodiversity Loss ( DNP 1997 ) Direct Causes forests had been negatively affected because of wood extrac - The country has been under an accelerated rate of destruction tion . Nevertheless , in the past years , wood industries have in - of its habitats and natural ecosystems due to such causes as creased their wood planting activities as well as their imports , inadequate land use policies that lead to colonization and decreasing their direct pressure over natural forests . land clearing for agricultural use . Other causes of habitat Another cause of biodiversity loss is domestic and in - destruction are the establishment of illicit crops , construction dustrial contamination . Contamination has affected natural of infrastructure and service works , mining activities , land environments when their carrying capacity has been sur - works to transform wetlands for pasture , firewood consump - passed . The damages due to contamination have not been tion , occurrence of fires in natural ecosystems , and in some quantified , but their impact can be foreseen by the following cases wood production . This transformation results in habitat data . In ï?? ï?? ï?? ï?? , only ï?? ï?? % and ï?? ï?? % respectively of urban and reduction or fragmentation . rural areas had disposal systems.Also , solid waste production Between ï?? ï?? ï?? ï?? and ï?? ï?? ï?? ï?? the main causes of land use was estimated to be ï?? ï?? , ï?? ï?? ï?? tons per day , of which only ï?? ï?? % changes can be summarized as follows : there was a decrease was disposed of in adequate waste facilities , ï?? % was buried , in land for agricultural use from ï?? million ha to ï?? . ï?? million ; ï?? ï?? % was left without any treatment in open air spaces , and land under pasture increased from ï?? ï?? . ï?? million ha to ï?? ï?? . ï?? ï?? ï?? % went to water bodies . Contamination is also produced million ha ; and there was a decrease in forest cover and other by insecticides and plague control substances . uses from ï?? ï?? . ï?? to ï?? ï?? . ï?? million ha . There is no consensus on what the countryâ??s yearly deforestation rate is . Nevertheless , Indirect Causes there are estimates that ï?? ï?? % of the cover of natural ecosys - Underlying the direct causes of biodiversity loss described tems has disappeared , with some specific areas under more above are a set of political , social , demographic , technologi - critical conditions . For example , theAndean Cordilleras have cal , institutional , and economic factors that are indirect causes lost ï?? ï?? % of their forest cover , and dry tropical forests have of biodiversity loss . The importance of biodiversity and its only ï?? . ï?? % of their original surface . relevance in achieving development goals has traditionally Another main cause of biodiversity loss is due to intro - being ignored by decision - makers and the mainstream de - duction of invasive species that have competed with and velopment policies of governments . Even though there is eventually displaced native species . This displacement has a growing consciousness of its importance , it is far from often imperiled the viability of populations or caused them being seriously considered by leaders in government or the to become extinct . Often the introduction of species is pro - private sector . moted by government policies , particularly in the case of Another major indirect cause is land distribution that has fisheries . For example , in the watersheds of the Amazon , often led to inappropriate land use patterns . Likewise , the lack Cauca , Orinoco , and Catatumbo rivers at least ï?? ï?? species of real land reform has led to the use of forest reserves by have been introduced , substantially reducing naturally oc - peasants in need of additional land . Further , policies regarding curring populations . illicit crop eradication have induced their shift from one place On the other hand , the over - exploitation and unsustainable to another , increasing land clearing to establish these crops , management of wild species of fauna and flora for domestic and having an enormous impact on the countryâ??s biodiversity . consumption or commercialization is also having important The areas where these crops have been established coincide effects on biodiversity . In Colombia , fauna is under severe largely with the location of the more vulnerable ecosystems pressure due to hunting , mainly to provide specimens , skins , in the Andes and Amazonia . and products for the illegal international market . The fisher - Also , a major cause of biodiversity loss is the very low ies are also affected by over - exploitation and by the use of institutional capacity to reduce impacts . Even though there inadequate fishing practices . For example , the watershed of is a complex environmental system in place , with a Ministry the Magdalena River has lost ï?? ï?? . ï?? % of its yearly production . of Environment , ï?? ï?? regional corporations that act as environ - Similar numbers have been reported for other watersheds . mental authorities , and four research institutes , their respon - Wood production by industry has also led to unsustainable sibilities surpass their capacity . Additionally , the government forest use , affecting substantial forested areas . Additionally , presence in remote areas of the country has traditionally been wood provision comes from the most biodiverse areas in the very low and the local empowerment weak , which has not country : the Amazonian and the Pacific Coast . Estimates for ï?? ï?? ï?? ï?? accounted that between ï?? ï?? , ï?? ï?? ï?? and ï?? ï?? , ï?? ï?? ï?? ha of natural contributed to biodiversity conservation . ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ The second stage required wide consultation at the national â?¢ There was a lack of understanding of the scope and state level , in order to discuss , modify and develop an of the ï쳌¥ ï쳌® ï쳌¢ ï쳌° ï쳌¡ . At the time , the government did not perceive the need to develop and implement a strat - strategy able to be implemented . egy and action plan focusing only in biodiversity . The first phase of the ï쳌® ï쳌¢ ï쳌³ ï쳌¡ ï쳌° developed the ten strategies It preferred to put all of its environmental goals of the ï쳌® ï쳌¢ ï쳌° , building upon the same principles of the policy . under a sole policy document , which is much more Nine working groups were established , which included general than an action plan . more than ï?? ï?? persons from different backgrounds , repre - senting various interests and stakeholders . These groups â?¢ There was lack of clarity of the role of different worked for a period of eight months , and the final edited institutions . Unlike other countries ( Peru , for result was published in ï?? ï?? ï?? ï?? ( F ï쳌¡ ï쳌® ï쳌¤ ï쳌© ï?± ï쳌¯ and F ï쳌¥ ï쳌² ï쳌² ï쳌¥ ï쳌© ï쳌² ï쳌¡ example , which has an institution devoted to the ï?? ï?? ï?? ï?? ) . implementation and development of a national bio - The second phase ( the consultation phase ) of the diversity strategy and action plan ) , in Colombia project never occurred due to institutional and political there is confusion about institutional responsibili - circumstances . Since the technical proposal was developed ties regarding biodiversity . Even though the law is during the final year of a government administration , it was clear that the ï쳌­ ï쳌¯ ï쳌¥ is in charge of approving envi - finished just as a new government with a new Minister of ronmental policies and the Humboldt Institute is a the Environment and a new senior staff took office . Even research institution that cannot assume political re - though assigning the responsibility of further development sponsibilities , the prominent role that Humboldt has of the proposal was decided by the same Ministry , it fi - played has created some confusion . Therefore , the nally opted not to adopt it formally and not to undertake Ministry does not perceive biodiversity as one of its the required political consultations . The following are the main responsibilities , even though a large amount main factors that may have led to this outcome : of its work pertains to biological resources . â?¢ There was a new political establishment that in - As a result Colombia does not have to date an officially herited a process already under development , and approved National Biodiversity Strategy and Action Plan . the ï쳌­ ï쳌¯ ï쳌¥ was reluctant to undertake a consultation Neither does it have a governing body directing and fol - on a proposal that was developed â?? outside â?쳌 the lowing its implementation . Nevertheless the published Ministry . document of the proposal has been de facto used by the â?¢ Biodiversity was not a political priority . In fact , the government as a policy framework for several of its ac - environmental priority at the time was water , and tions regarding biodiversity . Therefore , it is worthwhile to all environmental policy was supposed to revolve consider it in any policy analysis related to biodiversity around this topic , including biodiversity actions . in Colombia . Identification and Definition of Access Laws and Policies working on an action plan to facilitate the implementation Policies Related to Access to Genetic 5 of the Regional Biodiversity Strategy . 4 Resources From ï?? ï?? ï?? ï?? to ï?? ï?? ï?? ï?? the main governmental environmen - tal policy in Colombia was called the â?? Proyecto Colectivo On ï?? July ï?? ï?? ï?? ï?? , the Andean Community adopted a Ambiental â?쳌 ( â?? Environmental Collective Project â?쳌 ) . This Regional Biodiversity Strategy ( Decision ï?? ï?? ï?? ) under the policyâ??s Biodiversity Program did not consider the issue of auspices of the Inter - American Development Bank . This ï쳌¡ ï쳌¢ ï쳌³ as a central aspect . This trend continues in the present strategy includes an ï쳌¡ ï쳌¢ ï쳌³ component that provides a brief ( ï?? ï?? ï?? ï?? â?? ï?? ï?? ï?? ï?? ) governmental environmental policy . In ï?? ï?? ï?? ï?? , assessment of the problems experienced by the Andean the executive branch was partially reorganized and ï쳌­ ï쳌¯ ï쳌¥ Community in implementing Decision ï?? ï?? ï?? and proposes a was assigned housing responsibilities ( among other duties ) course of action to facilitate its implementation.According that became a high priority for the Ministry . Furthermore , to the strategy , Decision ï?? ï?? ï?? presents ambiguities that have ï쳌­ ï쳌¯ ï쳌¥ â?? s name was changed to Ministry of Environment , prevented not only its implementation at a national and Housing , and Land Development . ï쳌¡ ï쳌¢ ï쳌³ issues continue regional level , but has also prevented the advancement of to have a low priority within ï쳌­ ï쳌¯ ï쳌¥ . The ï쳌® ï쳌¢ ï쳌° and ï쳌¥ ï쳌® ï쳌¢ ï쳌° ï쳌¡ , science and the involvement of traditional communities however , provide more specific policy elements on the in access and benefit - sharing projects . Thus , the Regional topic . The ï쳌® ï쳌¢ ï쳌° and ï쳌® ï쳌¢ ï쳌³ ï쳌¡ ï쳌° contain five strategies related Biodiversity Strategy encourages the Andean Community directly or indirectly to the issue of ï쳌¡ ï쳌¢ ï쳌³ . These strategies , to develop a common strategy on access to genetic re - including a description of the policy objectives and goals sources that includes a better definition of the scope of pertaining to ï쳌¡ ï쳌¢ ï쳌³ , and a brief qualitative assessment of Decision ï?? ï?? ï?? and benefit - sharing issues , an increase in 6 their implementation , are as follows : local scientific capacity , and the development of a regional communication system on national access and benefit - â?¢ Promote sustainable development of the economic sharing initiatives . The Andean Community is currently potential of biodiversity . This strategy directly ad - ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : C ï쳌¯ ï쳌¬ ï쳌¯ ï쳌­ ï쳌¢ ï쳌© ï쳌¡ dresses the issue of ï쳌¡ ï쳌¢ ï쳌³ as one of the nine possible a Program with the main task of undertaking the countryâ??s biological inventory , which has substantially areas of economic potential of biological resources . advanced implementation the strategyâ??s goals . The strategyâ??s objective is to promote bioprospect - ing for the development and sustainable use of ge - â?¢ Recover , protect , and publicize traditional knowl - netic resources . It sets the following goals : edge . This is a key policy strategy related to ï쳌¡ ï쳌¢ ï쳌³ , â?? Increase the knowledge of wild flora , fauna , even though the strategyâ??s scope goes beyond and microorganisms with current and potential genetic resources . On the specific topic of access , uses as active principles in the development of the goal is to establish and implement norms and drugs , plague and illness control agents , etc . mechanisms for the protection of knowledge , wis - â?? Develop technologies , promote uses , and de - dom , innovations , and traditional practices . velop national and international markets that Main accomplishments : The debate over the way to allow for the maximization of added value to protect and recover traditional knowledge is highly these resources locally and nationally . controversial , and substantial discussions are still re - â?? Promote a national industry for the development quired to reach a consensus at the national level . This of products that require more sophisticated pro - is particularly true for knowledge related to genetic cesses . resources . The Humboldt Institute carried out a study â?? Improve the negotiation capacity of the ï쳌­ ï쳌¯ ï쳌¥ specifically related to the protection of traditional and relevant agencies in issues related to ï쳌¡ ï쳌¢ ï쳌³ knowledge in the context of ï쳌¡ ï쳌¢ ï쳌³ , and outlined a pro - and their derivatives . posal on the topic : â?? Protección al conocimiento tradi - â?? Consolidate a national industry of pharmaceuti - cional . Elementos conceptuales para una propuesta de cal products that originate from biodiversity to reglamentación â?? El caso de Colombia â?쳌 ( Protection of compete in national and international markets . traditional knowledge . Conceptual elements for a norm proposal â?? Colombiaâ??s case ) . This proposal provides â?? Develop and apply various techniques of eco - a relevant first step in continuing the national debate , nomic valuation of biodiversity to incorporate 7 before entering negotiations at the Andean level . the results in frameworks for decision making . Main accomplishments : The development of the â?¢ Promote ex situ conservation . This strategy is Colombian Biotrade Initiative ( Biocomercio ) has closely related to the topic of ï쳌¡ ï쳌¢ ï쳌³ . Its goals in - helped in developing markets and strengthening the clude completing the inventory of existing taxa entrepreneurial capacity to develop new biodiversity in ex situ collections ; selectively incorporating products ( not limited to genetic resources ) . into ex situ collections strategic components of biodiversity depending on their vulnerability or â?¢ Distribute benefits from biodiversity equitably . This their cultural , economic , ecological or evolution - strategy includes the equitable distribution of ben - ary importance ; strengthening of ex situ conserva - efits derived from biodiversity in general , including , tion banks ; strengthening human resources for ex but not limited to , genetic resources . Its approach situ conservation and related research ; creating a aims at strengthening the negotiation capacity for national information system of ex situ collections a more equitable distribution of benefits . There are and ; obtaining verifiable economic , social and eco - no specific indications of how fair and equitable logical benefits from ex situ conservation banks . distribution of benefits should be included in ï쳌¡ ï쳌¢ ï쳌³ The development of this strategy will significantly agreements . affect the way access to genetic resources occurs Main accomplishments : There are few advances in in Colombia . this area . Main accomplishments : There are substantial results in the implementation of this strategy nationwide , â?¢ Characterize the components of biological diver - mainly in terms of information management . There sity . There is an important relationship between this are still insufficient efforts to incorporate species of strategy and ï쳌¡ ï쳌¢ ï쳌³ since it is oriented at improving particular strategic importance in ex situ collections . the knowledge of Colombian biodiversity , includ - ing genetic resources . Its goals include increasing Legislation on Access to Genetic biological inventories , organizing available and Resources new information , and improving national research capacity for the characterization of biological Identification of Relevant Access Laws resources . Its development will allow for a better Although the most comprehensive piece of legislation understanding of what the country has to offer in for Colombia regarding ï쳌¡ ï쳌¢ ï쳌³ is Decision ï?? ï?? ï?? , there are terms of genetic resources . several other key laws and statutes related to genetic re - Main accomplishments : This strategy has achieved sources . Table ï?? includes the names of the pertinent ones in more tangible results . The Humboldt Institute has chronological order . The more relevant aspects of laws and ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ statutes and their relationship to ï쳌¡ ï쳌¢ ï쳌³ will be highlighted benefits arising out of the utilization of genetic resources . in this section . Additional information on how these laws The ï쳌£ ï쳌¢ ï쳌¤ also encourages the transfer of relevant technolo - and decrees relate to genetic resources may be obtained gies , through appropriate funding , taking into account all from Instituto Humboldt ( P ï쳌¡ ï쳌² ï쳌¤ ï쳌¯ ï?? ï?? ï?? ï?? a ) . rights over those resources and technologies ( ï쳌µ ï쳌® ï쳌¥ ï쳌° / ï쳌£ ï쳌¢ ï쳌¤ The ï쳌£ ï쳌¢ ï쳌¤ is considered the central piece of legislation ï?? ï?? ï?? ï?? ) . Additionally , the ï쳌£ ï쳌¢ ï쳌¤ recognizes the sovereign regarding biodiversity in Colombia . One of the objectives rights of nations over their natural resources and their of the ï쳌£ ï쳌¢ ï쳌¤ is to promote the fair and equitable sharing of authority to determine access to genetic resources . It also establishes that each contracting party should endeavor to create conditions to facilitate such access by other con - Table ï?? . Laws and norms related to genetic resources tracting parties and should not impose restrictions that Norm Title run counter to the intentions of the Convention . It further Decree Law ï?? ï?? ï?? ï?? of ï?? ï?? ï?? ï?? Natural Resources Code states that when access is granted it should be given under Decree ï?? ï?? ï?? of ï?? ï?? ï?? ï?? Regulates the Natural Resources mutually agreed upon terms . Additionally , it indicates that Code ( Decree ï?? ï?? ï?? ï?? / ï?? ï?? ) each contracting party shall endeavor to carry out scientific Decree ï?? ï?? ï?? ï?? of ï?? ï?? ï?? ï?? Regulates the Natural Resources research based on genetic resources provided by another Code ( Decree ï?? ï?? ï?? ï?? / ï?? ï?? ) regarding party with the providing partyâ??s full participation , and , if wild fauna . possible , to conduct that research in the country of origin . Law ï?? ï?? of ï?? ï?? ï?? ï?? ï쳌© ï쳌´ ï쳌´ ï쳌¯ Agreement Finally , it establishes that each party should take legisla - Decree ï?? ï?? ï?? ï?? of ï?? ï?? ï?? ï?? Regulates the Natural Resources Code ( Decree ï?? ï?? ï?? ï?? / ï?? ï?? ) regarding tive , administrative , or policy measures , as appropriate , issues of natural protected areas with the aim of sharing in a fair and equitable way the ( Integrated management districts ) . results of research and development . The agreement Political Constitution also requires that benefits arising from the commercial of ï?? ï?? ï?? ï?? or other utilization of genetic resources shall be shared Law ï?? ï?? of ï?? ï?? ï?? ï?? Convention No . ï?? ï?? ï?? on Indigenous with the contracting party providing such resources and people and tribes in independent such sharing should be upon mutually agreed terms . The countries ï쳌£ ï쳌¢ ï쳌¤ thus sets a comprehensive policy framework for ï쳌¡ ï쳌¢ ï쳌³ Law ï?? ï?? of ï?? ï?? ï?? ï?? Develops the ï?? ï?? transitory and requires countries to take the appropriate measures article of the Constitution ( black to facilitate it . communities ) Of the national legislation summarized in Table ï?? , Law ï?? ï?? of ï?? ï?? ï?? ï?? Creates the ï쳌­ ï쳌¯ ï쳌¥ and organizes the it is worth highlighting the contents of the Colombian National Environmental System Political Constitution and of Law ï?? ï?? of ï?? ï?? ï?? ï?? . The Political Decision ï?? ï?? ï?? of ï?? ï?? ï?? ï?? Common Regime for the Protection of Plant Variety Constitution establishes in Article ï?? ï?? , second paragraph , Breeders â?? Rights . that the State will regulate the entry and exit of genetic re - Law ï?? ï?? ï?? of ï?? ï?? ï?? ï?? Convention on Biological Diversity sources and their use according to national interests . Since Decree ï?? ï?? ï?? ï?? of ï?? ï?? ï?? ï?? Regulates the law of Afro - the Colombian State is sovereign over its genetic resources , Colombian communities it is entitled to legislate their conservation , use , import , Decree ï?? ï?? ï?? ï?? of ï?? ï?? ï?? ï?? Creates the National Commission export , and any other activity related to this resource . of Indigenous Territories and the Law ï?? ï?? of ï?? ï?? ï?? ï?? also creates the ï쳌­ ï쳌¯ ï쳌¥ and organizes the permanent harmonization table National Environmental System . Two relevant provisions with Indigenous Organizations . regarding ï쳌¡ ï쳌¢ ï쳌³ that develop the mandate of the Constitution Decision ï?? ï?? ï?? of ï?? ï?? ï?? ï?? Common Regime on Access to are given to the ï쳌­ ï쳌¯ ï쳌¥ . Article ï?? , numeral ï?? ï?? , gives the ï쳌­ ï쳌¯ ï쳌¥ Genetic Resources the function of regulating the securing , use , management , Law ï?? ï?? ï?? of ï?? ï?? ï?? ï?? For the protection of Colombian research , import , export , distribution , and commerce of flora , and regulates botanical gardens . species and genetic lineages of fauna and flora ; regulat - Decree ï?? ï?? ï?? of ï?? ï?? ï?? ï?? Determines the National ing import / export and commerce of such genetic material ; Competent Authority in the matter establishing the mechanisms and procedures of command of access to genetic resources . and control ; and arranging for the necessary claim of pay - Resolution ï?? ï?? ï?? of ï?? ï?? ï?? ï?? By which some functions of ments or acknowledgements of the rights or privileges be - Decision ï?? ï?? ï?? are delegated and stowed on the Nation due to the use of genetic material . In the internal procedures for access numeral ï?? ï?? of the same article , law ï?? ï?? / ï?? ï?? indicates that the to genetic resources and their ï쳌­ ï쳌¯ ï쳌¥ must ensure that the study , exploitation , and research , derivatives requests are set . both national and foreign , relating to Colombiaâ??s natural Decree ï?? ï?? ï?? of ï?? ï?? ï?? ï?? Regulates scientific research about resources respects national sovereignty and the rights of biological diversity . the Colombian Nation over its genetic resources . This law Decision ï?? ï?? ï?? of ï?? ï?? ï?? ï?? Common Regime on Industrial gave the ï쳌­ ï쳌¯ ï쳌¥ major responsibilities regarding ï쳌¡ ï쳌¢ ï쳌³ before Property Adopted from P ï쳌¡ ï쳌² ï쳌¤ ï쳌¯ ( ï?? ï?? ï?? ï?? ) and updated . the adoption of Decision ï?? ï?? ï?? . ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : C ï쳌¯ ï쳌¬ ï쳌¯ ï쳌­ ï쳌¢ ï쳌© ï쳌¡ Common Regime on Access to Genetic Resources â?? their intangible associated components , especially when referring to indigenous , Afro - Colombian , and Decision 391 local communities . Decision ï?? ï?? ï?? is a regional regime that was negotiated and adopted in ï?? ï?? ï?? ï?? under the Cartagena Agreement of â?¢ Promote the conservation of biological diversity the Andean Community . Decisions adopted under the and the sustainable use of biological resources that Cartagena Agreement are binding , and once approved , contain genetic resources . they are automatically integrated into national legislation â?¢ Promote the consolidation and development of for their execution , without requiring any approval by the scientific , technological , and technical capacities legislative apparatus of the member states ( ï쳌§ ï쳌´ ï쳌º / ï쳌¦ ï쳌µ ï쳌® ï쳌¤ ï쳌¥ ï쳌£ ï쳌¯ / at the local , national , and subregional levels . ï쳌© ï쳌¥ ï?? ï?? ï?? ï?? ) . Therefore , their application does not necessarily â?¢ Strengthen the negotiating capacity of member require the establishment of a new law , and can be imple - countries . mented with only a few additional dispositions ( C ï쳌¡ ï쳌© ï쳌¬ ï쳌¬ ï쳌¡ ï쳌µ ï쳌¸ et al . ï?? ï?? ï?? ï?? ) . Additionally , it is commonly understood as The Decision indicates the minimal requirements a general norm that establishes minimal rules applicable that must be taken into account when making an access to all member states , which countries can individually de - application . It also stipulates the need to establish a con - cide to develop further on their own or apply immediately tract agreement between those interested in the access ( ï쳌§ ï쳌´ ï쳌º / ï쳌¦ ï쳌µ ï쳌® ï쳌¤ ï쳌¥ ï쳌£ ï쳌¯ / ï쳌© ï쳌¥ ï?? ï?? ï?? ï?? ) . Therefore , this agreement is bind - activities and the National Competent Authority ( ï쳌® ï쳌£ ï쳌¡ ) ing for all countries of the Andean Community : Bolivia , in order to guarantee the objectives of the decision . This Colombia , Ecuador , Peru , and Venezuela . contract should take into account the rights and interests By the end of ï?? ï?? ï?? ï?? , the Andean Community ap - of the providers of the genetic resources and its derivative proved Decision ï?? ï?? ï?? regarding a Common Regime for the products , the providers of the biological resources that Protection of Plant Variety Breeders â?? Rights . This decision contain them , and the providers of intangible components , establishes that the member countries would adopt â?? a com - if applicable ( P ï쳌¡ ï쳌² ï쳌¤ ï쳌¯ ï?? ï?? ï?? ï?? a ) . The principal contract should mon regime on biogenetic resources , biosafety measures be supplemented with an appendix when access to genetic for the Sub region , in concordance with the Convention on resources or derivative products with an intangible com - Biological Diversity â?쳌 . After the approval of Decision ï?? ï?? ï?? , ponent are requested . This appendix should be signed by the first steps for the development of an access decision the provider of the intangible component and the applicant were initiated . Decision ï?? ï?? ï?? was adopted on ï?? July ï?? ï?? ï?? ï?? , to access , even though it may also be signed by the ï쳌­ ï쳌¯ ï쳌¥ and became officially binding on ï?? ï?? July ï?? ï?? ï?? ï?? , when it ( P ï쳌¡ ï쳌² ï쳌¤ ï쳌¯ ï?? ï?? ï?? ï?? a ) . Additionally , the Decision includes the was published in the Official Gazette of the Cartagena need for an accessory contract to protect the rights of the Agreement . It is considered a major development of the owners of the biological resources and of the landowners ï쳌£ ï쳌¢ ï쳌¤ on ï쳌¡ ï쳌¢ ï쳌³ . The following three major characteristics of where the resources are located . These aspects will be this Decision make it noteworthy : expanded upon later . 8 â?¢ Decision ï?? ï?? ï?? regulates the access to genetic re - Legal Developments of Decision 391 and Norms that 9 10 sources as well as to their derivative products . Contribute to its Implementation Therefore it is not limited to genetic resources per In Colombia two main additional legal dispositions se , but also includes other molecules of biological were adopted in order to facilitate the implementation of origin produced by living beings , with a broader Decision ï?? ï?? ï?? ( Table ï?? ) : scope than the specific provisions of the ï쳌£ ï쳌¢ ï쳌¤ . â?¢ Decision ï?? ï?? ï?? establishes that every country must â?¢ The agreement explicitly recognizes the importance determine an ï쳌® ï쳌£ ï쳌¡ for ï쳌¡ ï쳌¢ ï쳌³ purposes . This author - of knowledge associated with the genetic resources ity is a public entity authorized to provide genetic by considering it a central part of access under the resources or their derivative products , to subscribe 11 name â?? intangible component â?쳌 . Here again it goes to and oversee the contracts on ï쳌¡ ï쳌¢ ï쳌³ , and to comply beyond the original scope of the ï쳌£ ï쳌¢ ï쳌¤ . with the provisions of the decision . Decree ï?? ï?? ï?? â?¢ The Decision makes a reiterative separation be - of ï?? ï?? ï?? ï?? determined that the ï쳌® ï쳌£ ï쳌¡ is the ï쳌­ ï쳌¯ ï쳌¥ , thus tween biological resources on one hand and the empowering the Ministry as the unique authority genetic resources and their derivative products on 12 in all access issues in Colombia . the other , by indicating that the former contains â?¢ Resolution ï?? ï?? ï?? of ï?? ï?? ï?? ï?? clarifies the internal pro - the latter . cedures to be undertaken by the ï쳌­ ï쳌¯ ï쳌¥ to process ac - cess applications . These procedures will be detailed The following are the objectives and goals of Decision later . ï?? ï?? ï?? : â?¢ Provide conditions for a fair and equitable partici - Another legal development , adopted by Decree ï?? ï?? ï?? pation in the benefits derived from access . of ï?? ï?? ï?? ï?? that regulates scientific research relating to bio - â?¢ Establish the basis for the recognition and valuation diversity , contributes to the implementation of Decision 13 of genetic resources , their derivative products , and ï?? ï?? ï?? and was partially developed with this intent . This ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ Decree basically simplifies the permits , authorizations and tion or commercial use , among other activities . Finally , the Decision explicitly indicates that ex situ conservation cen - safe conducts that were required to undertake scientific ters or other entities that undertake activities relating ï쳌¡ ï쳌¢ ï쳌³ or research regarding biological diversity in Colombia by their derivative products or , if applicable , their intangible establishing a unique â?? study permit with the purpose of 14 components associated must sign access contracts . scientific research â?쳌 . This permit is required for activi - Therefore , the Decision explicitly includes all genetic ties of collection , recollection , capture , hunting , fishing , resources and derivative products under ex situ conditions , manipulation of the biological resources , and their mobili - thus including botanical collections , seed banks , zoos , zation through the national territory . It is worth noting that breeding centers , botanical gardens , aquariums , tissue the decree explicitly excludes issues pertaining to health banks , collections in natural history museums , herbaria , and agriculture except when these involve specimens or in vitro collections , and any other instance , center , or col - samples of wild fauna or flora ( Article ï?? ) . It also indicates lection that may possess genetic resources or derivative that foreigners willing to undertake scientific research in products that will be used for ï쳌¡ ï쳌¢ ï쳌³ purposes . This implies Colombia must present a Colombian co - researcher ( s ) to that Decision ï?? ï?? ï?? is also applicable to The International participate in the research activities . The decree has spe - Center for Tropical Agriculture , a research institution un - cific provisions related to access to genetic resources , and der the Consultative Group on International Agricultural the following should be highlighted : Research located in Colombia . â?¢ Any scientific research which requires obtaining and utilizing genetic resources , their derivative Industries and activities regulated by Decision 391 products , or their intangible components is subject The access definition of Decision ï?? ï?? ï?? is very broad . It to the decree and to all other norms pertaining to refers to access as related to the intent of those who wish access to genetic resources ( Article ï?? ï?? ) . to use the genetic resources , derivative product , or intan - â?¢ The granting of a study permit by an environmental gible component , in specifying that the purpose must be authority does not require the ï쳌­ ï쳌¯ ï쳌¥ to authorize ac - for â?? research , bioprospecting , conservation , industrial ap - cess to genetic resources . plication , or commercial profit , among others â?쳌 ( Article ï?? , Decision ï?? ï?? ï?? ) . Therefore , a wide range of activities may lie TheAutonomous Regional Corporations ( i.e . , regional within this definition , but exactly which activities should environmental agencies ) thus may have an indirect role be regulated under the Decision is still unclear . in the application of Decision ï?? ï?? ï?? when they grant a The Decision also makes a clear distinction between study permit that may involve ï쳌¡ ï쳌¢ ï쳌³ with respect to the genetic resources and derivative products , and biological activities regulated by Decree ï?? ï?? ï?? of ï?? ï?? ï?? ï?? or any other resources , thus limiting the scope of the Decision by ex - activity that the access project may require that may lie cluding biological resources that are not used or acquired within the Corporationâ??s functions . However , the Regional with the intent of access to genetic resources or their de - Corporations do not have any major authority , nor do they rivative products . This exclusion is nonetheless difficult take part in the evaluation of ï쳌¡ ï쳌¢ ï쳌³ or the granting of access to understand as all biological material contains genetic contracts . Nevertheless , the ï쳌­ ï쳌¯ ï쳌¥ may consult the Regional material or derivative products . Corporations if it considers this useful and may even in - However difficult the interpretation of the Decision volve them in follow up and oversight activities of a given may be regarding what activities are covered , it is neces - ï쳌¡ ï쳌¢ ï쳌³ contract , through specific agreements . sary to keep in mind both the intention of the Regime No future legal reforms to implement the Decision have and the practical aspects of its application . It would be been proposed to date . Still required is the development a mistake to require access contracts for a wide range of of policies ( as will be analyzed below ) and of additional activities that require the use of biological material , un - legislation for the protection of traditional knowledge . In der the premise that biological materials contain genetic fact , Decision ï?? ï?? ï?? establishes that a special regime or material . harmonization norm should be established for the protec - An example to illustrate this point , even though con - tion of knowledge , innovations , and traditional practices of troversial , is the exchange of botanical collections for indigenous , Afro - Colombian , and local communities . taxonomic identification . Botanical samples not intended Ex Situ Conservation Entities , Industries , and for ï쳌¡ ï쳌¢ ï쳌³ purposes are frequently sent to experts for the Activities Regulated by Decision 391 purpose of taxonomic identification . Nevertheless , an Ex situ conservation organizations ï쳌® ï쳌£ ï쳌¡ may believe that since a biological resource contain - The Common Regime on ï쳌¡ ï쳌¢ ï쳌³ clearly indicates that it is ing genetic resources is exchanged , an access contract is applicable to those countries that are countries of origin required . This is even more of an issue if the sample is of genetic resources , their derivative products , and their exported to a foreign collection . The ï쳌® ï쳌£ ï쳌¡ is correct that intangible components . Additionally , access is defined as access can occur , but it is mistaken in requiring an access the obtainment and utilization of genetic resources in ex contract , because the intent is taxonomic identification situ or in situ conditions , their derivatives , and , if it is the and not access to genetic resources . Nevertheless , the case , their intangible components , with the purpose of access definition of Decision ï?? ï?? ï?? allows for this ample research , bioprospecting , conservation , industrial applica - interpretation of the norm . ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : C ï쳌¯ ï쳌¬ ï쳌¯ ï쳌­ ï쳌¢ ï쳌© ï쳌¡ Even more difficulties arise when other types of activi - Regulation of Access Activities in a Given Place ties are analyzed . For example should biological resources For the purpose of covering access activities in a given from which botanical extracts are obtained , purified , or place , Decision ï?? ï?? ï?? established the form of accessory con - processed for commercial purposes be included ? Under a tracts . It indicates that accessory contracts are those that , strict interpretation of Decision ï?? ï?? ï?? they can be included , for the completion of activities related to access to genetic but it is unclear whether this is the right policy choice . resources or their derivative products , must be established The activities and industries that should definitely between the applicant to such access and : be covered by Decision ï?? ï?? ï?? are thus difficult to identify . â?¢ The owner , possessor , or administrator of the es - Therefore it is the duty of each of the countries of the tate where the biological resource containing the Andean Community to reflect upon this complex subject genetic resource is located ; in order to determine the appropriate interpretation of the â?¢ The ex situ conservation center ; Decision . Ideally , this interpretation should be agreed upon â?¢ The owner , possessor , or administrator of the biologi - by all countries , and the appropriate forum to discuss this cal resource containing the genetic resource ; or topic would be theAndean Committee onAccess to Genetic 15 Resources , which was created by Decision ï?? ï?? ï?? . In fact , â?¢ The national support institution for activities that within the Andean Regional Biodiversity Strategy , such may be undertaken that are not part of the access discussions have already begun at a very general level . contract . In Colombia , the Humboldt Institute has begun to Other characteristics of such accessory contracts are analyze the subject . One of its publications regarding that their establishment does not grant the access to genetic Colombian legislation states : resources or its derivative products , and their content is It is important to acknowledge that there are practical dif - subject to whatever is established in the access contract . ferences between using biological resources and access - Also they do not enter into force unless the access contract ing genetic resources , because the access to a biological is valid . Similarly , if the ï쳌® ï쳌£ ï쳌¡ judges that the accessory con - resource implies the physical action of collecting , taking , tract is vital to obtaining access , it may terminate the access hunting or cultivating . Biological resources can be used and profited as a whole . On the contrary , to access a contract when the accessory contract is declared null . genetic resource , the biological resource must undergo These are the main provisions covering access activi - a transformation process that allows separating and ties in a given place or land . The purpose of the accessory isolating the genetic resources or derivative products , contract is to protect the legally acquired rights and inter - through technologies developed for that purpose . Thus , ests of the owners of the estates and biological resources in order to access genetic resources it is necessary first that contain the desired genetic resources . Therefore , the to access the biological resource . Nevertheless , the ac - Colombian state cannot disregard the rights of third par - cess to a biological resource does not necessarily imply ties or interfere in the free exercise of the property rights the access to a genetic resource . In this sense , the object of individuals ( P ï쳌¡ ï쳌² ï쳌¤ ï쳌¯ ï?? ï?? ï?? ï?? a ) . Rarely , if national interest of the access is completely different and must be taken into account to determine the applicable legislation surpasses private interest , the government may decide to ( P ï쳌¡ ï쳌² ï쳌¤ ï쳌¯ ï?? ï?? ï?? ï?? a ) . expropriate a given property and make it public in order to grant an access contract . Nevertheless , this would be an Even though there is a relevant advancement in the extreme situation and is very unlikely to occur . analysis of the topic , this interpretation has not been The provisions of the accessory contract apply to ac - officially adopted by the ï쳌­ ï쳌¯ ï쳌¥ , nor has it been debated . cess activities on all types of properties , and identifying This issue thus requires further analysis and development the appropriate parties to the contract depends on who is in Colombia , as well as in the other Andean nations . In the owner , possessor , or administrator of the estate where Colombia the project â?? Design of a Policy on Access to the biological resource containing the genetic resource Genetic Resources and their Derivatives for Colombia â?쳌 is located . In the case of public lands or marine areas , or which the Humboldt Institute will complete in ï?? ï?? ï?? ï?? , will national protected areas , for example , the owner is the likely address this central issue . The implications of the State . The owners of private or community owned lands interpretation of the norm over scientific research should be are the private individuals or the community ; therefore , the carefully analyzed , in order to avoid creating unjustifiable applicant to access must enter into contracts with them . obstacles to research efforts in the region . In Colombia , the use of biological resources has a Therefore , bioprospectors from the pharmaceutical , distinctive applicable legislation , and there are diverse agricultural , botanical medicine , and biotechnology fields laws over the use of wild resources . Additionally , it is may be included in the scope of Decision ï?? ï?? ï?? , because now clear that genetic resources are State property by it covers all access activities without particular consider - inalienable right and cannot be seized , or proscribed ations or exclusions of any given sector . Nonetheless , until as stated by the Colombian State Court ( Sentence ï?? ï?? ï?? more specific guidelines are developed , these activities of August ï?? ï?? ï?? ï?? ) . Therefore , the access applicant must must be analyzed on a case - by - case basis based on the agree on a contract with the state as owner of the genetic activity they will undertake in order to determine whether they are covered or not by Decision ï?? ï?? ï?? . resource . Additionally , it must enter into an agreement ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ with the owner of the biological resource if the resource indicates that compliance with environmental legislation is privately owned , and with the owner , administrator , or must be considered when evaluating the request ( Article possessor of the land where the biological resource con - ï?? ï?? , Decision ï?? ï?? ï?? ) . taining the desired genetic resource is located . Nevertheless , ï쳌® ï쳌¢ ï쳌³ ï쳌¡ ï쳌° may provide some guidance in the type of access applications that the country may favor , Enforcement of Decision ï?? ï?? ï?? even though this is by no means an evaluation standard . Decision ï?? ï?? ï?? gives the ï쳌® ï쳌£ ï쳌¡ a major role in its evaluation , Similarly , Decision ï?? ï?? ï?? in article ï?? ï?? indicates that the monitoring and enforcement ( Article ï?? ï?? , Decision ï?? ï?? ï?? ) . It access applications and contracts , and , if applicable , the is the entity responsible for formulating the dispositions re - appendices , should include parameters such as those speci - quired to comply with the Decision at the national level . It fied in the Article . These are not evaluation standards , but must receive , evaluate , admit , or reject access applications ; they indicate the type of access applications that may be negotiate , subscribe to , and authorize access contracts and favored . Such parameters are : 16 issue the corresponding access resolutions ; watch over â?¢ The participation of citizens from the region in re - the rights of the providers of biological resources that search activities of access to genetic resources , their contain genetic resources and the intangible components ; derivative products , and intangible components ; keep records of access applications and accompanying â?¢ The support of research within a member country technical material ; modify , suspend , resolve , or rescind that is the country of origin of the genetic resource access contracts and nullify them if necessary ; decide on or any other country from the region that contrib - national support institutions and their suitability ; supervise utes to the conservation and sustainable use of and control compliance with the conditions of the contracts biodiversity ; and of the dispositions of the Decision , establishing the â?¢ The strengthening of mechanisms of transfer of mechanisms of supervision and evaluation it considers knowledge and technologies , including biotech - necessary ; review previously granted access contracts and nologies , that are culturally , socially , and environ - adjust them as necessary ; delegate supervision activities to mentally safe and healthy . other entities while maintaining control and responsibility â?¢ The supply of background information and state over such supervision according to internal legislation ; of the art or science that may contribute to a bet - supervise the state of biological resources containing the ter knowledge of the situation of a given genetic genetic resource ; carry out the national inventory on ge - resource , its derivative or synthesized product , and netic resources and its derivative products ; and maintain the associated intangible component that originates appropriate communication and information exchange from a given member state ; with intellectual property right ( ï쳌© ï쳌° ï쳌² ) authorities at the â?¢ The strengthening and development of the institu - national level . tional national or sub regional capacity associated Decree ï?? ï?? ï?? of ï?? ï?? ï?? ï?? determines that the ï쳌­ ï쳌¯ ï쳌¥ of with genetic resources and its derivative products ; Colombia is the ï쳌® ï쳌£ ï쳌¡ , thus giving this Ministry all of these responsibilities . Additionally , Law ï?? ï?? of ï?? ï?? ï?? ï?? had â?¢ The strengthening and development of the capacity already given the ï쳌­ ï쳌¯ ï쳌¥ several major functions in related of indigenous , Afro - Colombian , and local commu - 17 genetic resources topics . nities in relation to intangible knowledge associ - Decision ï?? ï?? ï?? also defines a set of parameters for ated with the genetic resources and their derivative infringement and sanctions . It states that anyone under - products ; taking access activities without due authorization will â?¢ The deposit of duplicates of all collected material be sanctioned . This also applies to persons undertaking in institutions determined by the ï쳌® ï쳌£ ï쳌¡ ; 18 transactions related to derivative or synthesized products â?¢ The obligation of providing the ï쳌® ï쳌£ ï쳌¡ with the results from genetic resources or to their intangible associated of the research undertaken ; and components . The ï쳌® ï쳌£ ï쳌¡ must apply the sanctions accord - â?¢ The terms of the transfer of the accessed material ing to the countryâ??s national laws and such sanctions will to third parties . apply without affecting other sanctions such as access or Even though the above parameters may help the access payment of damages for harm caused . applicant develop its access proposal , they are insufficient Standards for Evaluation of Access Applications from a policy point of view . The ï쳌® ï쳌£ ï쳌¡ needs to adopt policy Decision ï?? ï?? ï?? does not establish any specific standards for guidelines with this in mind in order to facilitate the access 19 the evaluation of access applications . It only establishes a process and to make it more clear and efficient . set of prerequisites for an application to be accepted . It also ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : C ï쳌¯ ï쳌¬ ï쳌¯ ï쳌­ ï쳌¢ ï쳌© ï쳌¡ Description of Legislation Relevant to ABS Because there was no specific policy on ï쳌¡ ï쳌¢ ï쳌³ in Colombia may be used by the applicant are the parameters described as of July ï?? ï?? ï?? ï?? , this section will be completely devoted to in Article ï?? ï?? of the Decision . Guidelines for the content a description of the relevant existing legislation . and scope of this project proposal need to be defined by the ï쳌® ï쳌£ ï쳌¡ in an official policy document that can be used as a reference by applicants . The definition of such parameters Steps to Obtain Access to Genetic would substantially facilitate the access process both for Resources the applicant and for the ï쳌® ï쳌£ ï쳌¡ . The steps required for an applicant interested in obtaining Evaluation of the Access Application and Project Proposal access to genetic resources , their derivative products , and Within ï?? ï?? working days of its official acceptance , the ï쳌® ï쳌£ ï쳌¡ the associate intangible components ( i.e . , knowledge ) are will evaluate the proposal and will undertake the inspec - clearly described in Decision ï?? ï?? ï?? . In this section these tions it regards as necessary . The ï쳌® ï쳌£ ï쳌¡ will issue a legal steps will be described , along with an analysis of the and technical statement indicating whether the request is difficulties that may arise in their implementation and or is not approved . This time frame may be expanded up suggestions of how they could be improved . None of the to ï?? ï?? working days at the ï쳌® ï쳌£ ï쳌¡ â?? s discretion . suggestions require any legal reform of Decision ï?? ï?? ï?? ; most Taking into account the legal and technical statement , of them call for the development of policies defining key the compliance with the Decision , and other analysis , the aspects of the access process . ï쳌® ï쳌£ ï쳌¡ will accept or deny the request . Applicants will be It is worth noting that the procedures of Decision ï?? ï?? ï?? notified of the acceptance of the application and project are exactly the same for Colombians and for foreigners . proposal within five working days of the ï쳌® ï쳌£ ï쳌¡ â?? s decision . Also , there are no differences between applications for If the request and project proposals are accepted , the ï쳌® ï쳌£ ï쳌¡ scientific research and for commercial purposes . will proceed to negotiate and elaborate the terms of the access contract . If the request and project proposals are Presentation of an Access Application not accepted , the ï쳌® ï쳌£ ï쳌¡ will communicate its decision to The process to access genetic resources or their derivatives the applicant by resolution stating the reasons of such begins with the presentation by the applicant of a request denial and will terminate the procedure . The applicant to the ï쳌® ï쳌£ ï쳌¡ , ( i.e . , the ï쳌­ ï쳌¯ ï쳌¥ ) . The request must include the may appeal this decision through a process determined prerequisites that are indicated in Decision ï?? ï?? ï?? , Article by national legislation . ï?? ï?? . There is no government fee for the presentation of the Even though this step is straightforward , the difficulty 20 application . Of these prerequisites it is worth highlight - lies in the fact that the evaluation criteria are not defined ing the following : the identification of the provider of the or even outlined in an officially adopted policy document . genetic and biological resources , their derivative products , This makes it more difficult for the applicant to submit a and intangible components ; the identification of the person successful proposal and for the ï쳌­ ï쳌¯ ï쳌¥ to evaluate it . Even or national support institution ; the identification and cur - though there is a learning curve in evaluating the access riculum vitae of the responsible leader of the project and proposals on a case - by - case basis , the ï쳌® ï쳌£ ï쳌¡ must use this of its working group ; the access activity that is requested ; learning process in order to outline the basis for evalua - and the locality or area where the access will take place , tion criteria . indicating its geographic coordinates . In addition , the re - Elaboration of the Access Contract quest must be accompanied by a project proposal . Decision ï?? ï?? ï?? indicates that after the request has been If the proposal and all additional materials are com - officially accepted a period of negotiation between the plete , the ï쳌® ï쳌£ ï쳌¡ will accept it , and the process will be ï쳌® ï쳌£ ï쳌¡ and the applicant will occur , after which an access officially initiated . If the application is incomplete , the contract is signed . The terms or other characteristics of the applicant will be notified without delay and apprised negotiation and the time frame in which it is to take place of the missing items , in order for the application to be are not specified by the Decision . The negotiation stage completed . If accepted , an abstract of the application will is one of the major hurdles of the access process , again be published within five days in a media source of wide because of the lack of a government policy . Additionally , national circulation , as well as in a media source in the the scope of the negotiation is not completely clear , given locality where the access is requested . that the request and project proposal have already been One major aspect of this access application may be accepted . This aspect should be clarified and developed . unclear : the requirement to present a â?? project proposal â?쳌 . It is implicit that the negotiation should address issues This project proposal , along with the credentials of re - such as the distribution of benefits and take into account search group , should be a key element in evaluating the the compliance with the Decision and its intent , etc . access application . However there are no guidelines , either Nevertheless , the parameters provided by the Decision in in the Decision or any other policy document , as to what its content and scope should be . The only references that this respect are insufficient because they do not specify the ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ interests of the government of Colombia when entering Biodiversity Strategy is also a clear indication of the com - mitment of Andean countries to strengthen their capacity into an access contract . These interests should be defined to implement the ï쳌£ ï쳌¢ ï쳌¤ . in a policy on ï쳌¡ ï쳌¢ ï쳌³ . Additionally , Decision ï?? ï?? ï?? has supported the Colom - The legislation indicates that a contract agreement must bian governmentâ??s position in several international negotia - be entered into between the ï쳌® ï쳌£ ï쳌¡ and the applicant , and tions and forums related to genetic resources . It provided it also indicates the requirements for the appendix to the the government with a solid political basis to construct the contract and the accessory contract already described in 22 countryâ??s position for the î?? î?? î?¡ International Undertaking , this paper . It is not clear whether these documents must the ï쳌£ ï쳌¢ ï쳌¤ , World Trade Organization forums , as well as for precede or follow the signing of the access contract . the negotiation of Decision ï?? ï?? ï?? or Common Regime on Enactment of the Contract Industrial Property . Table ï?? shows the laws that relate to Once the access contract has been adopted and signed , the ï쳌¡ ï쳌¢ ï쳌³ . In this section , a brief reference to their relationship ï쳌® ï쳌£ ï쳌¡ will issue and publish an access resolution , accompa - to Decision ï?? ï?? ï?? will be provided . nied by an abstract of the contract , in the official gazette or The relationship between Decision ï?? ï?? ï?? and Law ï?? ï?? ï?? of newspaper of wide national circulation . The contract will ï?? ï?? ï?? ï?? of ï쳌£ ï쳌¢ ï쳌¤ has already been established . Nevertheless , it be considered as perfected once this step is taken . is worth highlighting again that Decision ï?? ï?? ï?? was basically The length of the whole procedure depends on the dura - adopted to comply with the provisions of the ï쳌£ ï쳌¢ ï쳌¤ , and it tion of the negotiation between the applicant and the ï쳌® ï쳌£ ï쳌¡ . follows the spirit of the Convention . All other legal steps described above require a maximum The ï쳌© ï쳌´ ï쳌´ ï쳌¯ agreement shares a common purpose with of ï?? ï?? working days . the Decision because it has the objective of promoting the conservation and sustainable use of the tropical forests Government Capacity to Negotiate ABS and of its genetic resources ( Law ï?? ï?? of ï?? ï?? ï?? ï?? , cited by P ï쳌¡ ï쳌² ï쳌¤ ï쳌¯ ( ï?? ï?? ï?? ï?? ) ) . The same is true of Convention No . ï?? ï?? ï?? Agreements on Indigenous People and Tribes in Independent Countries , The current capacity for evaluating , negotiating , and which states that the rights of the people over the natural monitoring ï쳌¡ ï쳌¢ ï쳌³ proposals is very low , mainly because the resources existing in their lands must be specially pro - ï쳌­ ï쳌¯ ï쳌¥ and other institutions have diverse responsibilities tected . These rights include the right to participate in the in many areas . In addition , there are no experts in the use , management , and conservation of these resources . It specific topics of ï쳌¡ ï쳌¢ ï쳌³ involved in the evaluation process . also indicates that when the state has ownership or rights Resolution ï?? ï?? ï?? of ï?? ï?? ï?? ï?? establishes that the evaluation and over the resources existing in these lands , the govern - negotiation stages must be coordinated with the Ministry of ment must establish procedures for consulting with the Interior , the Ministry of Foreign Commerce , the Ministry interested communities before allowing any exploration of Agriculture , and other entities related to the ï쳌­ ï쳌¯ ï쳌¥ , as on their lands . The people must always participate in the well as private and public universities , in particular the benefits that these activities produce and receive equitable National University of Colombia ( Universidad Nacional indemnification for any harm they may suffer as the result de Colombia ) and the Amazonian University . of these activities ( Law ï?? ï?? of ï?? ï?? ï?? ï?? , cited by P ï쳌¡ ï쳌² ï쳌¤ ï쳌¯ ï?? ï?? ï?? ï?? a ) . Decision ï?? ï?? ï?? embraces the intent of Law ï?? ï?? by creating provisions protecting the rights of the people over their Relationship between Decision 391 and lands and protecting their knowledge through accessory International Laws and Policies contracts and the appendix to the contract . The issue of ï쳌¡ ï쳌¢ ï쳌³ is central to Colombian foreign policy Decision ï?? ï?? ï?? or Common Regime for the Protection of regarding biodiversity . This policy is centered on three PlantVariety Breeders â?? rights is closely related to access to aspects : ï?? ) the application of the ï쳌£ ï쳌¢ ï쳌¤ , ï?? ) restrictions on plant genetic resources , because it establishes a sui generis the application of ï쳌© ï쳌° ï쳌² s , and ï?? ) promotion of the sustain - property rights regime regulating plant breeders â?? rights , able use of genetic resources and equitable distribution of thus protecting the farmers and regulating ownership of 21 monetary and nonmonetary benefits . newly developed plant varieties . The regime complies with There were two main motives for the development of the provisions of the International Union for the Protection an agreement on ï쳌¡ ï쳌¢ ï쳌³ at the Andean level : implementing of New Varieties of Plants . the ï쳌£ ï쳌¢ ï쳌¤ and regional integration between Andean coun - Decision ï?? ï?? ï?? or Common Regime on Industrial tries . Both are international policies of the Colombian Property has the strongest relation to the topic of ï쳌¡ ï쳌¢ ï쳌³ and government . Also , within the Andean Community , there thus with Decision ï?? ï?? ï?? . There is a direct assertion that has been a strong interest in environmental issues as a the elements of industrial property must safeguard and key element of the integration process . Environmental respect the genetic patrimony of the states , as well as the issues have been addressed in eight presidential Councils knowledge of indigenous , black , and local communities . of the Cartagena Agreement , and the commission has de - Any patent granted using genetic material or knowledge veloped at least six Decisions related to agricultural and from a country of the region requires the material to have biological resources . The agreement to develop anAndean been acquired according to international , regional , and ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : C ï쳌¯ ï쳌¬ ï쳌¯ ï쳌­ ï쳌¢ ï쳌© ï쳌¡ national norms ( in the case of Colombia , according to comply with the applicable environmental legislation . Decision ï?? ï?? ï?? and related regulations ) . Therefore , the ap - Additionally , it indicates that member states can estab - plicant must present the access contract , appendix , and lish limitations to access and their derivative products by accessory contracts , if applicable ; otherwise , the patent a special legal norm , in the following cases : will be null . Additionally , the Decision explicitly excludes â?¢ Endemism , rarity , or danger of extinction of spe - the granting of patents on parts of live resources as they cies , subspecies , varieties , or lineages ; exist in nature , including the genome or germplasm of any â?¢ Conditions of vulnerability or fragility in the natural living organism . Therefore , it prohibits patents over structure or function of ecosystems that may be accessed genetic material if it exists as such in a living aggravated because of access activities ; organism . The relationship between access and Decision â?¢ Adverse effects over human health or over essential ï?? ï?? ï?? will be analyzed later . elements of the cultural identity of the people ; â?¢ Undesirable or uncontrollable environmental im - Provisions that Promote the Conservation pacts caused by access activities on ecosystems ; of Biodiversity , its Sustainable Use and the â?¢ Danger of genetic erosion due to access activities ; Fair and Equitable Distribution of Benefits â?¢ Biosafety regulations ; and â?¢ Genetic resources or geographic areas determined The central spirit of Decision ï?? ï?? ï?? is the conservation and as strategic . sustainable use of biological and genetic resources , and Finally , in addition to these specific references , the the fair and equitable distribution of benefits . Two of its access , appendix , and accessory contracts are the main five goals are related to these concepts : â?? to provide the instruments to promote the conservation and sustainable conditions for a fair and just participation in the benefits use of biodiversity and to seek the equitable and fair dis - derived from access to genetic resources â?쳌 and â?? to promote tribution of benefits . There are no specific indications on the conservation of biological diversity and the sustain - how these objectives should be reached , and they should able use of the biological resources containing genetic be further developed by theAndean Committee on Genetic resources â?쳌 ( Decision ï?? ï?? ï?? ï?? ï?? ï?? ï?? ) . Decision ï?? ï?? ï?? states that the applicant for access must Resources and by national policies . Process that Led to the Development of Decision 391 National discussions over ï쳌¡ ï쳌¢ ï쳌³ increased in Colombia soon of the Andean Community asked the World Conservation after the Biodiversity Convention was ratified by the coun - Union ( ï쳌© ï쳌µ ï쳌£ ï쳌® ) , which lately involved Peruvian Society for 23 try . In particular there was a nongovernmental organiza - Environmental Law ( ï쳌³ ï쳌° ï쳌¤ ï쳌¡ ) , to develop a first draft of the tion ( ï쳌® ï쳌§ ï쳌¯ ) initiative named the â?? National Biodiversity elements that should be considered in an access regime . Strategy â?쳌 ( ï쳌® ï쳌¢ ï쳌³ ) which was important in these discussions . This draft was presented to the countries in ï?? ctober ï?? ï?? ï?? ï?? From a legal standpoint , by the end of ï?? ï?? ï?? ï?? the Andean under the title â?? Possible Elements for a Decision of the Community approved Decision ï?? ï?? ï?? ( Common Regime Andean pact about Access to Genetic Resources â?쳌 ( J ï쳌µ ï쳌® ï쳌´ ï쳌¡ for the Protection of Plant Variety Breeders â?? Rights ) . In A ï쳌£ ï쳌µ ï쳌¥ ï쳌² ï쳌¤ ï쳌¯ ï쳌¤ ï쳌¥ C ï쳌¡ ï쳌² ï쳌´ ï쳌¡ ï쳌§ ï쳌¥ ï쳌® ï쳌¡ ï?? ï?? ï?? ï?? ) . In September ï?? ï?? ï?? ï?? , there this regime , the countries already indicated their interest were already deep differences with the ï쳌© ï쳌µ ï쳌£ ï쳌® / ï쳌³ ï쳌° ï쳌¤ ï쳌¡ pro - in developing an Andean norm related to ï쳌¡ ï쳌¢ ï쳌³ and agreed posal , as well as resistance from some governments even to adopt a common regime on biogenetic resources and to have such a document as a basis for discussion . Also , a biosafety for the region . Soon after that , the formal discus - number of other draft norms emerged from various groups . sions of such a norm were initiated . In Colombia , inAugust ï?? ï?? ï?? ï?? , the ï쳌® ï쳌¢ ï쳌³ produced an alterna - An analysis of the process that led to the decision has tive draft , â?? Proyecto de Decisión Andina sobre Acceso a 24 identified two main motivations that resulted in the negotia - Recursos Genéticos â?? Propuesta de Colombia â?쳌 . These tion of Decision ï?? ï?? ï?? ( C ï쳌¡ ï쳌© ï쳌¬ ï쳌¬ ï쳌¡ ï쳌µ ï쳌¸ et al . ï?? ï?? ï?? ï?? ) : ï?? ) The need to various documents were discussed in a regional workshop develop legislation to protect genetic resources in order to in Villa de Leyva , Colombia . This workshop had wide gain control over the inventions derived from them , given participation ( ï쳌® ï쳌§ ï쳌¯ â?? s , academic institutions , private sector , the increased strength of ï쳌© ï쳌° ï쳌² regimes after Decision ï?? ï?? ï?? intergovernmental institutions , and indigenous organiza - had been approved , and ï?? ) the fact that Andean countries tions ) from the Andean countries . Nevertheless , there was share , in general terms , a great amount of their biodiversity . increased tension in the debate between â?? conservation â?쳌 The countries thus wanted to avoid competition between and â?? commercialization â?쳌 , which led government repre - themselves and opted for the adoption of a common set sentatives to decide to isolate themselves from the ï쳌® ï쳌§ ï쳌¯ of rules and the promotion of cooperative mechanisms process ( C ï쳌¡ ï쳌© ï쳌¬ ï쳌¬ ï쳌¡ ï쳌µ ï쳌¸ et al . ï?? ï?? ï?? ï?? ) . As a result , the ï쳌® ï쳌§ ï쳌¯ s and between countries . At the Andean level , the initial dis - others contributing to the debate lost their opportunity to cussions on the ï쳌¡ ï쳌¢ ï쳌³ norm had the ample participation of participate in the development of the Decision ( C ï쳌¡ ï쳌© ï쳌¬ ï쳌¬ ï쳌¡ ï쳌µ ï쳌¸ various sectors of civil society . Moreover , the Secretariat et al . ï?? ï?? ï?? ï?? ) . ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ Most governments felt uncomfortable discussing the some feel that topics such as traditional knowledge and development of an access norm based on an ï쳌® ï쳌§ ï쳌¯ draft the equitable distribution of benefits were not developed proposal . In fact , after this phase of active civil society enough . An additional perception is that not all participat - participation , a number of government proposals were ing experts had adequate legal , technical , scientific , and put forth , and the formal instances of debate and negotia - economic experience to develop an access regime , which tion began to be called â?? government expert meetings â?쳌 . In is partially explained by the fact that there is no strong November ï?? ï?? ï?? ï?? , the Colombian and Venezuelan govern - experience within Colombia in the biotechnology , phar - ments jointly presented a new draft Decision for discus - maceutical , or agricultural industries either in research or sion . The next year , the governments of both Bolivia and business development ( C ï쳌¡ ï쳌© ï쳌¬ ï쳌¬ ï쳌¡ ï쳌µ ï쳌¸ et al . ï?? ï?? ï?? ï?? ) . Ecuador proposed two different texts of draft decisions . From the reading of the official reports of these meet - Finally , the discussions between government officials ings , it is possible to observe that there was a sense of developed around these three governmental drafts . There urgency to approve a decision . There were also extensive were six expert meetings which led to the elaboration of a proposals regarding the definition of access and what it final proposal that was presented to the Commission of the should cover . The group finally adopted a wide - ranging Cartagena Agreement for its approval in July ï?? ï?? ï?? ï?? . definition based on a Colombian proposal , which is very Analyses of the process indicate that the opportunity close to the current access definition of Decision ï?? ï?? ï?? . It for wider participation in the debate and groundwork on is worthwhile noting that the negotiators possessed much a topic of such relevance as ï쳌¡ ï쳌¢ ï쳌³ was lost . Indeed , some less information than we do now regarding the activities argue that the conflicting attitude between ï쳌® ï쳌§ ï쳌¯ s led the and opportunities that ï쳌¡ ï쳌¢ ï쳌³ offers . Therefore , they tried to governments , and particularly the Colombian government , do their best using a very wide definition that can cover all to shy away from the broad debate that characterized the types of activities . Unfortunately , the result of the applica - early stages of the development of the decision.As a result , tion of this norm has been the opposite of its intent . Difficulties During the Design of Decision 391 A number of issues were controversial during the develop - resources and a weak definition of the protection of traditional knowledge . In fact the Decision creates ment of Decision ï?? ï?? ï?? . The main ones will be highlighted : the basic instruments to protect traditional knowl - â?¢ Conservation vs . Commercialization . The main edge but delegates the solution to future negotia - controversial issue was the tension between a tions . It indicates that the Cartagena Board must conservationist decision and a norm targeted at elaborate a proposal of a special regime or harmoni - controlling the flow of genetic resources with a zation norm oriented to the protection of traditional more â?? commercial â?쳌 perspective ( C ï쳌¡ ï쳌© ï쳌¬ ï쳌¬ ï쳌¡ ï쳌µ ï쳌¸ et al . knowledge , innovations , and practices within three ï?? ï?? ï?? ï?? ) . Some ï쳌® ï쳌§ ï쳌¯ s , in particular , wanted a broader months of July ï?? ï?? ï?? ï?? . The issue is so controversial norm aimed at the conservation and sustainable use that such a proposal has not emerged , nor have the of biodiversity from a larger perspective . The other countries pursued all the steps indicated by the group thought that there were other instruments to norm ( i.e . , to undertake national studies on the topic do this , including the ï쳌£ ï쳌¢ ï쳌¤ . Finally , governments and carry out training workshops in communities ) opted for a focused regime solely oriented at ï쳌¡ ï쳌¢ ï쳌³ in order to develop such a proposal . issues . â?¢ The â?? green gold â?쳌 perception . The other issue that â?¢ Scientific and Traditional Knowledge . The was a cause of debate was the perception by some treatment of knowledge involves both scientific government officials that genetic resources were the and traditional knowledge . There was the intent to â?? green gold â?쳌 of theAndean countries . Some people protect traditional knowledge and to respect scien - gave genetic resources an extremely high economic tific knowledge simultaneously . Some ï쳌® ï쳌§ ï쳌¯ s wanted value and expected an immediate high economic a special access process for the cases that involved return from their use ( C ï쳌¡ ï쳌© ï쳌¬ ï쳌¬ ï쳌¡ ï쳌µ ï쳌¸ et al . ï?? ï?? ï?? ï?? ) . This traditional knowledge . Additionally , there was in - perception was not accepted by all participants and terest in protecting traditional knowledge from a was a cause of tension in the debates . Finally , the larger perspective , and there were not any other governments opted for a norm aimed at strictly forums to do so . The governments opted for a mid - controlling the flow of genetic resources and their point solution that treats both types of knowledge export to third countries , under the premise that 25 as intangible components associated with genetic important sums of money were at stake . ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : C ï쳌¯ ï쳌¬ ï쳌¯ ï쳌­ ï쳌¢ ï쳌© ï쳌¡ Implementation of Decision 391 in Colombia Even though Decision ï?? ï?? ï?? has been in place since ï?? ï?? ï?? ï?? , â?¢ Uncertainty regarding issues related to the protec - by February ï?? ï?? ï?? ï?? , not a single access contract had been tion of traditional knowledge and whether they will signed in Colombia . Also , the number of access appli - be defined or not ; cations has been low : in total the ï쳌­ ï쳌¯ ï쳌¥ has received ï?? ï?? â?¢ Expectations of high economic benefits on the part access applications , which are summarized in Table ï?? . of governments and indigenous communities ; Overall , a similar situation is occurring in the otherAndean â?¢ Difficulties in the negotiations of accessory contracts countries . Between July ï?? ï?? ï?? ï?? and July ï?? ï?? ï?? ï?? , Venezuela , with the providers of the biological resources ( ex - Ecuador , Bolivia , and Peru received only ï?? ï?? applications . cessive expectations of economic remuneration ) ; Of these , one was approved , four were denied , two did â?¢ Lack of an appropriate information system ; not require access contracts , and the others are under evaluation ( ï쳌§ ï쳌´ ï쳌º / ï쳌¦ ï쳌µ ï쳌® ï쳌¤ ï쳌¥ ï쳌£ ï쳌¯ / ï쳌© ï쳌¥ ï?? ï?? ï?? ï?? ) . Simply put , there â?¢ Lack of compliance with the terms and timetable has been very little implementation of Decision ï?? ï?? ï?? . The established by Decision ï?? ï?? ï?? ; and Decision has been useful to the subregion in setting up â?¢ Lack of sufficient economic resources for imple - strong positions in international forums such as the ï쳌¦ ï쳌¡ ï쳌¯ mentation . International Undertaking negotiations , but it has not been particularly useful at the national level . It has served mainly On the other hand , the Decision has not yet reached as a framework to analyze the access proposals that have the main purposes for which it was developed . First of all , been presented . One must suspect that most access activi - the countries do not have a unified access policy , one of ties in Colombia , and in other Andean countries , both for the initial motivations of the norm ( F ï쳌¥ ï쳌² ï쳌² ï쳌¥ ï쳌© ï쳌² ï쳌¡ and P ï쳌¡ ï쳌² ï쳌¤ ï쳌¯ research and commercial purposes , are currently conducted ï?? ï?? ï?? ï?? ) , because they have given the Decision such a wide illegally . Potential applicants for access do not understand range of interpretations . Another main purpose was to be the decision , or they ignore it , perceiving it as an obstacle able to control the flow of genetic resources . This has not to research and development . occurred due to the lack of implementation of the Decision . Table ï?? summarizes the access proposals that have been Finally , the norm could have provided favorable condi - submitted to the ï쳌­ ï쳌¯ ï쳌¥ , and provides information about the tions for promoting interesting access agreements . This applicant , the objective of the project , and its status . Most has not happened because applicants do not feel sufficient of the applications are solely for scientific research and do legal certainty or clear negotiation conditions ( F ï쳌¥ ï쳌² ï쳌² ï쳌¥ ï쳌© ï쳌² ï쳌¡ not have commercial purposes . It is worth noting that in and P ï쳌¡ ï쳌² ï쳌¤ ï쳌¯ ï?? ï?? ï?? ï?? ) . As was pointed out before , the Andean several cases the applicant withdrew from the access pro - Committee on ï쳌¡ ï쳌¢ ï쳌³ provides a valuable forum to discuss cess . Box ï?? summarizes the case of BioAndes , which has and develop implementing solutions . been the only application with commercial purposes . In the case of Colombia , there is the perception from Several of the implementing obstacles for Colombia the ï쳌­ ï쳌¯ ï쳌¥ , the Ministry of Commerce , and research institu - have been identified already in this document . At the tions such as the Humboldt Institute that the norm can Andean level the main difficulty is the interpretation be successfully applied without legal reform . There is of the Decision ï?? ï?? ï?? ( ï쳌§ ï쳌´ ï쳌º / ï쳌¦ ï쳌µ ï쳌® ï쳌¤ ï쳌¥ ï쳌£ ï쳌¯ / ï쳌© ï쳌¥ ï?? ï?? ï?? ï?? ) both by an agreement that the current legal framework can work , governments and access applicants . A summary of other even to actively promote ï쳌¡ ï쳌¢ ï쳌³ activities in Colombia , if implementing difficulties is the following ( ï쳌§ ï쳌´ ï쳌º / ï쳌¦ ï쳌µ ï쳌® ï쳌¤ ï쳌¥ ï쳌£ ï쳌¯ / the appropriate procedures and policy developments are ï쳌© ï쳌¥ ï?? ï?? ï?? ï?? ) : set in place . In fact , the lack of a clear and publicized â?¢ Confusion over which activities require access government policy has had three grave results : the lack 26 contracts ; of application of the norm , leading to illegal access , the insufficient active promotion of access activities , and a â?¢ Lack of knowledge of the norm by potential users ; weak and unclear response to the few access applications â?¢ Lack of experienced and qualified personnel to that have been submitted . The result : a net loss of oppor - inform the public ; tunities for the sustainable use of genetic resources . There â?¢ Insufficient information regarding access proce - are currently two major efforts to address these needed dures ; developments . First , the ï쳌­ ï쳌¯ ï쳌¥ hired a research institute of â?¢ Confusion over the most important terms of the the National University of Colombia to develop key access norm and the role of different parties ; concepts and procedures . Secondly , the Humboldt Institute is undertaking a research project that will lead to a policy â?¢ Lack of interest by potential applicants to get in - volved in a complicated , expensive , and uncertain proposal on ï쳌¡ ï쳌¢ ï쳌³ . procedure ; ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ Intellectual Property Rights and Bioprospecting TheAndean countries in general , and Colombia in particu - â?¢ Encourage research activities in the Andean region . lar , have comprehensive ï쳌© ï쳌° ï쳌² legislation , some of which is â?¢ Promote technology transfer activities within and specifically related to biodiversity . Table ï?? summarizes the outside the subregion . legal norms related to ï쳌© ï쳌° ï쳌² s and biodiversity in Colombia Decision ï?? ï?? ï?? of ï?? ï?? ï?? ï?? is the newly approved Common ( P ï쳌¡ ï쳌² ï쳌¤ ï쳌¯ ï?? ï?? ï?? ï?? b ) . Regime on Industrial Property . With this Decision , the Of this group of norms , two are particularly relevant in Andean Community complied with the Agreement on the context of ï쳌¡ ï쳌¢ ï쳌³ and bioprospecting . These are Decision Trade - Related Aspects of Intellectual Property Rights ï?? ï?? ï?? and Decision ï?? ï?? ï?? . Decision ï?? ï?? ï?? , Common Regime ( ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ ) requirements . In fact , this is why Decision ï?? ï?? ï?? for the Protection of Plant Variety Breeders â?? Rights , es - was replaced . Furthermore , the process leading to the com - tablishes the intent of Andean Community to develop a mon regime on industrial property was largely promoted common regime on ï쳌¡ ï쳌¢ ï쳌³ . This Decision has the following by the Colombian Government ( M ï쳌© ï쳌® ï쳌© ï쳌³ ï쳌´ ï쳌¥ ï쳌² ï쳌© ï쳌¯ ï쳌¤ ï쳌¥ C ï쳌¯ ï쳌­ ï쳌¥ ï쳌² ï쳌£ ï쳌© ï쳌¯ objectives ( ï쳌§ ï쳌´ ï쳌º / ï쳌¦ ï쳌µ ï쳌® ï쳌¤ ï쳌¥ ï쳌£ ï쳌¯ / ï쳌© ï쳌¥ ï?? ï?? ï?? ï?? ) : E ï쳌¸ ï쳌´ ï쳌¥ ï쳌² ï쳌© ï쳌¯ ï쳌² ï?? ï?? ï?? ï?? ) . Decision ï?? ï?? ï?? has critical provisions related to ï쳌¡ ï쳌¢ ï쳌³ : â?¢ Recognize and guarantee the protection of the rights of breeders of new plant varieties through a â?¢ Article ï?? establishes that member countries will certificate . guarantee that elements of industrial property be Table ï?? . Access proposals presented to the ï쳌­ ï쳌¯ ï쳌¥ of Colombia between ï?? ï?? ï?? ï?? and early ï?? ï?? ï?? ï?? Project name Applicant Project objective Status ï?? . Access application to BioAndes de Colombia Research of in vitro bioactive After several resolutions and ( Joint venture between compounds for the treatment new proposal by BioAndes all of Colombian genetic Andes Pharmaceuticals Inc . of cancer and other diseases . the request was denied in resources in all Colombian â?? ï쳌µ ï쳌³ ï쳌¡ and ï쳌¥ ï쳌² ï쳌³ Associates December ï?? ï?? ï?? ï?? . territory ( February ï?? ï?? ï?? ï?? ) . â?? Colombia ) . Revised proposal : Access to all of genetic resources in natural protected areas ( May ï?? ï?? ï?? ï?? ) . Second pro - posal : access to all genetic resources excluding park areas contested by civil law or inhabited by indigenous or Afro - Colombian com - munities . ï?? . Identification of the Alejandro Calixto Research to identify hiber - The application was submit - nating sites of migrating ted in July ï?? ï?? ï?? ï?? and filed importance of hibernating species . after the applicant withdrew . sites of four North America migrating bird species ( Catharus ustulatus , Seiurus noveboracensis , Setophaga ruticilla , and Dendroica striata ) , by using genetic markers and census in the National Natural Park of Tinigua . ï?? . Genetic analysis of Fungi Adriana Mercedes , Determine phylogenetic In February ï?? ï?? ï?? ï?? the Gil Correa applicant withdrew and the Ustilaginales from the col - relationships among the application was filed . lection of the Colombian fungi analyzed . Research for National Herbaria . academic purposes . ï?? . Analysis of the genetic Eulalia Banguera Hinestroza Contribute to the taxonomic The access request was ac - variation and degree of cepted in ï?? ï?? ï?? ï?? . The process knowledge of this river genetic isolation in the popu - has not concluded and the dolphin species by using lations of Inia geoffrencis negotiation phase and sign - genetic markers . Provide in the Amazon and Orinoco ing of the access contract are information to contribute to basins . pending . the development of policies and conservation strategies for the dolphin populations . ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : C ï쳌¯ ï쳌¬ ï쳌¯ ï쳌­ ï쳌¢ ï쳌© ï쳌¡ granted protection while respecting their biological â?¢ Article ï?? ï?? establishes restrictions to patents . In and genetic patrimony , as well as the traditional particular , it indicates that plants , animals , and knowledge of their indigenous , black , and local essentially biological procedures for the produc - communities . It further states that patents for inven - tion of plants or animals that are not nonbiological tions developed from material obtained from this procedures will not be subject to patents . patrimony or such knowledge will only be granted â?¢ Article ï?? ï?? regarding the requirements for obtaining if this material has been acquired in conformity a patent establishes that the applicant must present : with the international , subregional , and national a ) a copy of the access contract when the products legal systems . It states that member countries or procedures of the patent requested have been recognize the rights and authority of indigenous , obtained or developed from genetic resources or black , and local communities over their collective their derivatives of which any of the member coun - knowledge . It also indicates that Decision ï?? ï?? ï?? will be applied and interpreted in such a manner that it tries are countries of origin and b ) if applicable , a should not contravene Decision ï?? ï?? ï?? . copy of the authorization for the use of traditional Table ï?? . Continued Project name Applicant Project objective Status ï?? . Analysis of the genus María Alejandra Jaramillo Request for taxonomic Additional information Trianopiper . Expedient No . was requested by ï쳌­ ï쳌¯ ï쳌¥ in scientific research . The ï?? ï?? ï?? ï?? . December ï?? ï?? ï?? ï?? . objective was to pursue a taxonomic revision of the species of the Trianopiper genus using genetic tools . ï?? . Study of genetic diversity María Eloisa Aldana Study of the genetic structure The applicant withdrew its of the genus Cattleya of the request in June ï?? ï?? ï?? ï?? . of the orchid genus Cattleya Andean Region of Colombia of the Colombian Andes , using ï쳌¡ ï쳌¦ ï쳌¬ ï쳌° . Expedient No . including the extraction of ï?? ï?? ï?? ï?? . ï쳌¤ ï쳌® ï쳌¡ . The study would allow for a better understanding of the genus classification and provide strategies for its ex situ and in situ conservation . ï?? . Export permit of samples Diego Amorocho Genetic study for the con - Additional information and of tissue and blood from permits have been requested servation of the turtle in the the marine turtles , genus by ï쳌­ ï쳌¯ ï쳌¥ in ï?? ï?? ï?? ï?? . Department of Magdalena . Caretta . Expedient No . The objective is to determine ï?? ï?? ï?? ï?? . the size and structure of the populations of the marine turtles . ï?? . Expedient ï?? ï?? ï?? ï?? . Not publicly available Not publicly available Under evaluation ï?? . Access to genetic resourc - Disneyâ??s Animal Kingdom The access requested is Under evaluation . es and their derivatives of aimed at determining the the â?? Mono Titi â?쳌 ( Sanguinus hormonal levels of several oedipus ) . Expedient No . females , through sampling ï?? ï?? ï?? ï?? . of feces . Additionally the genetic variability within a population will be deter - mined , including paternity and relationships between the individuals of each con - servation group through skin and hair samples . The main purpose of the research is the ecology and behavioral traits of the populations of the cot - ton - top tamarin , Sanguinus oedipus , in their natural environment . ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ knowledge from indigenous , black , and local com - As was explained above , Colombia does not have in place a comprehensive system to protect traditional munities , when the products for which the patent knowledge . In fact , this has been a major hurdle to access is requested have been obtained or developed from because most communities feel they do not have suffi - such knowledge of which any of the member coun - cient protection of their rights . Decision ï?? ï?? ï?? establishes tries is a country of origin , according to Decision that a norm to protect these rights has to be proposed at ï?? ï?? ï?? and its developments . the Andean level , but this has not occurred . The issue is There is a very strong connection between the two so controversial at the national , subregional , and interna - regimes , as Decision ï?? ï?? ï?? strengthens the relevance of tional levels that there is not a clear foreseeable outcome . ï쳌¡ ï쳌¢ ï쳌³ procedures . Therefore , it is extremely important for In Colombia there has been some conceptual progress Andean countries to promptly implement Decision ï?? ï?? ï?? in with the development of elements for the elaboration of a order not to block the ï쳌© ï쳌° ï쳌² regulation . protection regime for traditional knowledge , innovations , As for other proposals made in terms of ï쳌© ï쳌° ï쳌² , the Latin and practices ( S ï?¡ ï쳌® ï쳌£ ï쳌¨ ï쳌¥ ï쳌º et al . ï?? ï?? ï?? ï?? ) . Nevertheless , this American and Caribbean Group have proposed to include is an academic proposal that may serve as an initial basis the issue of traditional knowledge in the negotiations of for discussion but that still requires wide opportunities 27 the Free Trade Area for the Americas and ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ . These for debate , discussion , and modification from Colombian propositions are still under development and debate . traditional communities . Recommendations to Facilitate Access to Genetic Resources in other Countries The most relevant recommendations to facilitate access are outstanding : in Colombia were outlined in previous sections of this â?¢ The country lacks the capacity to put the norm in paper . Some lessons can be derived from the Andean place due to institutional limitations , insufficient experience , and in fact developers of several of the new budget , and lack of appropriate expertise . laws and policies worldwide regarding access have already â?¢ The scope of the norm is not clearly defined . After benefited from these lessons . The recommendations that almost six years there is no consensus on what ac - emerge from the Andean and Colombian process can be cess to genetic resources means and includes , what summarized as follows . type of activities it covers , and what relationship it The main problem with Decision ï?? ï?? ï?? is its lack of implementation . This problem has many origins , but two has to the use of biological resources . The defini - Table ï?? . Continued Project name Applicant Project objective Status ï?? ï?? . Isolation and identifica - Director , Institute of Study of a microorganism The application was filed in Biotechnology ( National with â?? levansacarasa â?쳌 activ - January ï?? ï?? ï?? ï?? . tion of a microorganism with University of Colombia ) ity . â?? levansacarasa â?쳌 activity . Expedient No . ï?? ï?? ï?? ï?? ï?? ï?? . Bird malaria in Colombia . Medicine Department , Study of malaria present Additional information was Expedient No . ï?? ï?? ï?? ï?? . University of Antioquia in the bird population of requested by the ï쳌­ ï쳌¯ ï쳌¥ on ï?? ï?? Colombia February ï?? ï?? ï?? ï?? . ï?? ï?? . Genetic diversity Eliana Gonzales Valencia Analysis of genetic diver - Additional information was requested by the ï쳌­ ï쳌¯ ï쳌¥ on ï?? ï?? of three populations of sity of the endangered tree November ï?? ï?? ï?? ï?? . Colombobalanus excelsa . species , Colombobalanus Expedient No . ï?? ï?? ï?? ï?? excelsa ( Fagaceae ) ï?? ï?? . Study of amphibians and Taran Grant , American Analysis of the diversity of Additional information was reptiles in eastern Colombia Museum of Natural History amphibians and reptiles in requested by ï쳌­ ï쳌¯ ï쳌¥ on ï?? ï?? eastern Colombia March ï?? ï?? ï?? ï?? . ï?? ï?? . Request for three research Director Humboldt Institute Unknown , additional infor - mation was requested by projects . Expedient No . has ï쳌­ ï쳌¯ ï쳌¥ on ï?? ï?? August ï?? ï?? ï?? ï?? . not been assigned yet . ï?? ï?? . Genetic characterization Susana Caballero Analysis of the genetic ï쳌­ ï쳌¯ ï쳌¥ should be making a of the South American dol - decision in ï?? ï?? ï?? ï?? . diversity of the South phin . Expedient No . ï?? ï?? ï?? ï?? American dolphin for scientific ( noncommercial ) purposes . ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : C ï쳌¯ ï쳌¬ ï쳌¯ ï쳌­ ï쳌¢ ï쳌© ï쳌¡ tion of access in the Decision is too wide , impeding its scientific and technical capacity through access activi - ties ? Does it want to promote foreign investment or does its implementation and creating confusion both in it want more stringent norms on foreigners to discourage the ï쳌® ï쳌£ ï쳌¡ and among persons interested in access their ï쳌¡ ï쳌¢ ï쳌³ activities ? What is the role of the government ? activities . Should the government determine what technology transfer The lessons derived are straightforward : takes place ? These policy choices have to be evaluated and properly debated . Once defined , they will provide â?¢ Put in place legislation that can effectively be im - a useful framework for the implementation of the norm plemented , even if it is less ambitious in its scope and / or the promotion of access activities . As in the case than may be ideal : at least some of the access activi - of the Andean countries , it is clear that the existence of ties will be undertaken under legal terms , and the the decision alone is not enough . country can gradually learn from the process and Another lesson that can be derived from the Andean advance to more complicated schemes if necessary . process is that these governments rushed to have a decision It is necessary to guarantee that the appropriate in place , in their urgency to protect their genetic patri - resources ( institutional , human capacity , budget , mony . The net result so far has been the opposite of what etc . ) are available to put the norm in place . they intended . Even though the negotiations surrounding â?¢ Clearly define a reasonable scope of what the leg - Decision ï?? ï?? ï?? began with open debate , they ended with a islation covers , thus minimizing confusion from 28 very limited group of so called â?? government experts â?쳌 . government and the users . Also , it is necessary to Apparently not all â?? government experts â?쳌 had sufficient define the relationship with other natural resource expertise in access issues , and none of the countries had uses that very likely have their own legislation in practical experience in pharmaceutical or other relevant place and should be dealt with separately . areas . As a result , they developed a norm with their best knowledge and certainly with good intentions , but with The Colombian experience also demonstrates that the considerable implementation difficulties . The negotiation lack of policy on ï쳌¡ ï쳌¢ ï쳌³ issues has exacerbated the low rate process could have benefited from the following : of implementation of Decision ï?? ï?? ï?? . If the Colombian â?¢ A wider consultation with experts from different government had a policy framework to implement the fields , including international experts with practical decision , most of its difficulties could be overcome . experience on access activities ; Within the definition of the policy the most important task is to identify the countryâ??s policy objectives : Does â?¢ A more sustained discussion , not limited to ï쳌® ï쳌§ ï쳌¯ s , the country want to control all flows of genetic resources ? with the different stakeholders , including academic Does it want to promote technology transfer and increase interests and the private sector ; and Box 2 . The case of BioAndes ( Information from COLUMBIA UNIVERSITY ( 1999 ) and from the MOE Public Expedients and Resolutions ) The BioAndes case has been the only access application with â?¢ Absence of cash - sharing benefit schemes , although Bio - commercial purposes that has taken place in Colombia . In Andes had asked for a principle of equitable treatment . February ï?? ï?? ï?? ï?? BioAndes formally submitted an ï쳌¡ ï쳌¢ ï쳌³ request Later BioAndes appealed the ï쳌­ ï쳌¯ ï쳌¥ decision , arguing that for drug discovery in all Colombian Territory . This initial the ample application scope was necessary to warrant the vi - request was later modified to focus on the National Natural ability of the enterprise , and that the taxonomic breadth was Park System , excluding contested areas or areas inhabited by justified by the bioassay method to be used . It also argued that indigenous or black communities . The application was for the strategic alliances were not required because the elaboration collection of random biological materials for the elaboration of the extracts was common practice . It also claimed that of extracts for the research of in vitro bioactive compounds Decision ï?? ï?? ï?? did not require monetary compensation as part for the treatment of cancer and other diseases . This first ap - of the application process . plication was denied by the ï쳌­ ï쳌¯ ï쳌¥ in November ï?? ï?? ï?? ï?? arguing Afterwards the ï쳌­ ï쳌¯ ï쳌¥ reiterated its decision , but it did the following : emphasize some positive aspects of the initial application . â?¢ Geographic inaccuracy : it was proposed to sample sites BioAndes appealed , and in May ï?? ï?? ï?? ï?? presented a second in all protected areas of the system . access application , this time limiting research to ï?? ï?? - ï?? ï?? pro - â?¢ Taxonomic inaccuracy : the application included a request tected areas , excluding all parks inhabited by traditional com - to sample all taxonomic groups in Colombia , both marine munities . The taxonomic scope was still wide ; and the group and terrestrial . planned to â?? examine plants with known medicinal activity â?¦ â?¢ Absence of strategic alliances with local partners for tech - purchased at market places â?쳌 and to use â?? popular literature â?쳌 to nology transfer and lack of a National Support Institution gather information about useful plants . This second request ( BioAndes did not meet the requirements since it was the was again denied in November ï?? ï?? ï?? ï?? , and the ï쳌­ ï쳌¯ ï쳌¥ gave its applicant to access ) . final negative response in December ï?? ï?? ï?? ï?? . ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ and molecular biology . â?¢ Lengthier discussions on the purpose and philo - sophical intent of the Decision . Even though the â?¢ In the access application , ask for detailed informa - negotiation process took two and a half years , op - tion about the research project that is proposed . 29 portunities for debate were not sufficient . That will provide useful information for the evalu - ation process and orient the applicant in developing A related lesson is that the issue of traditional knowl - a more appropriate access proposal . edge was not properly addressed.As was stated before , this issue is so controversial and sensitive that the countries â?¢ Do not overestimate the economic benefits to the opted to postpone the discussions . This has , in practical government that will arise from access activities . terms , left the topic undeveloped , creating a major difficul - Rather , promote other non - economic benefits ty for the implementation of the norm , not to mention the such as technology transfer and scientific devel - discomfort and discontent of traditional communities . opment . Other more specific rescommendations to governments â?¢ Minimize the role of the government and promote that arise from this analysis are the following : more active participation from the private sector , â?¢ Provide legal certainty to all stakeholders . ï쳌® ï쳌§ ï쳌¯ s , and local communities . After a few initial basic steps , the role of the government should be â?¢ Do not put in place a law with an access model that is too rigid . Set a more flexible scheme that to oversee the access activities , not to control every allows learning from the process and benefiting flow of genetic resources . from technological innovations in biotechnology Table ï?? . Legal norms that address ï쳌© ï쳌° ï쳌² issues related to biodiversity in Colombia Norm Title Norm Title Political Constitution Law ï?? ï?? ï?? of ï?? ï?? ï?? ï?? Approves the Paris Convention for 30 of ï?? ï?? ï?? ï?? the Protection of Industrial Property . Law ï?? ï?? of ï?? ï?? ï?? ï?? Convention No . ï?? ï?? ï?? on Indigenous Decree ï?? ï?? ï?? ï?? of ï?? ï?? ï?? ï?? Develops chapter ï?? of Law ï?? ï?? of People and Tribes in Independent ï?? ï?? ï?? ï?? , adopts the recognition of the 31 Countries ( Articles ï?? ï?? and ï?? ï?? ) collective property of the land of Decision ï?? ï?? ï?? of ï?? ï?? ï?? ï?? Common Regime on Industrial Afro - Colombian communities and Property ( substituted for by Decision other dispositions . ï?? ï?? ï?? ) . 33 Law ï?? ï?? ï?? of ï?? ï?? ï?? ï?? Frontiers Law ( Articles ï?? and ï?? ) . Decision ï?? ï?? ï?? of ï?? ï?? ï?? ï?? Common Regime for the Protection Law ï?? ï?? ï?? of ï?? ï?? ï?? ï?? International Convention for the of Plant Variety Breeders â?? Rights Protection of Plant Varieties . Law ï?? ï?? of ï?? ï?? ï?? ï?? Develops the ï?? ï?? th Transitory Decision ï?? ï?? ï?? of ï?? ï?? ï?? ï?? Common Regime on Access to Article of the Constitution ( black Genetic Resources . communities ) Decree ï?? ï?? ï?? ï?? of ï?? ï?? ï?? ï?? Creates the dNational Commission Law ï?? ï?? of ï?? ï?? ï?? ï?? Creates the ï쳌­ ï쳌¯ ï쳌¥ and Organizes the on Indigenous Territories and the National Environmental System 33 Permanent Agreement table with the ( Article ï?? # ï?? ï?? ) . People and Indigenous Organizations Decree ï?? ï?? ï?? of ï?? ï?? ï?? ï?? Develops Decision ï?? ï?? ï?? . 34 ( Article ï?? ï?? ) Decree ï?? ï?? ï?? of ï?? ï?? ï?? ï?? Develops the Common Regime on the Protection of Plant Varieties . Law ï?? ï?? ï?? of ï?? ï?? ï?? ï?? Approves the Cooperation Treaty in Patents . Law ï?? ï?? ï?? of ï?? ï?? ï?? ï?? Convention on Biological Diversity . Decision ï?? ï?? ï?? of ï?? ï?? ï?? ï?? Common Regime on Industrial Law ï?? ï?? ï?? of ï?? ï?? ï?? ï?? Adopts an Agreement related to ï쳌© ï쳌° ï쳌² issues related to Commerce . Property . ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : C ï쳌¯ ï쳌¬ ï쳌¯ ï쳌­ ï쳌¢ ï쳌© ï쳌¡ References C ï쳌¡ ï쳌© ï쳌¬ ï쳌¬ ï쳌¡ ï쳌µ ï쳌¸ , J . , M . R ï쳌µ ï쳌© ï쳌º , and B . T ï쳌¯ ï쳌¢ ï쳌© ï쳌® . ï?? ï?? ï?? ï?? . El Régimen Andino países . Manuscript . Comunidad Andina de Naciones , de Acceso a los Recursos Genéticos : Lecciones y experien - Estrategia Regional de Biodiversidad . Bolivia . cias . ï쳌³ ï쳌° ï쳌¤ ï쳌¡ , Lima , Perú and ï쳌· ï쳌² ï쳌© , Washington ï쳌¤ ï쳌£ ï쳌µ ï쳌³ ï쳌¡ . M ï쳌© ï쳌® ï쳌© ï쳌³ ï쳌´ ï쳌¥ ï쳌² ï쳌© ï쳌¯ ï쳌¤ ï쳌¥ C ï쳌¯ ï쳌­ ï쳌¥ ï쳌² ï쳌£ ï쳌© ï쳌¯ E ï쳌¸ ï쳌´ ï쳌¥ ï쳌² ï쳌© ï쳌¯ ï쳌² . ï?? ï?? ï?? ï?? . Informe de avance C ï쳌¨ ï쳌¡ ï쳌¶ ï쳌¥ ï쳌³ S . , M.E . and N . A ï쳌² ï쳌¡ ï쳌® ï쳌§ ï쳌¯ V . ( eds . ) . ï?? ï?? ï?? ï?? . Informe del Plan Nacional de Desarrollo de Julio ï?? ï?? ï?? ï?? a Junio Nacional Sobre el Estado de la Biodiversidad Colombia , ï?? ï?? ï?? ï?? . ï쳌µ ï쳌² ï쳌¬ : http : / / www.mincomex.gov.co . ï?? ï?? ï?? ï?? . Tomo I . Diversidad biológica . Instituto Humboldt . J ï쳌µ ï쳌® ï쳌´ ï쳌¡ A ï쳌£ ï쳌µ ï쳌¥ ï쳌² ï쳌¤ ï쳌¯ ï쳌¤ ï쳌¥ C ï쳌¡ ï쳌² ï쳌´ ï쳌¡ ï쳌§ ï쳌¥ ï쳌® ï쳌¡ . ï?? ï?? ï?? ï?? . Hacia un marco Colombia . legal para regular el acceso a los recursos genéticos en C ï쳌¯ ï쳌¬ ï쳌µ ï쳌­ ï쳌¢ ï쳌© ï쳌¡ U ï쳌® ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ . ï?? ï?? ï?? ï?? . Access to genetic resources : el Pacto Andino . Posibles elementos para una Decisión An evaluation of the development and implementation del Pacto Andino sobre acceso a los recursos genéticos . of recent regulations and access agreements . School of Unpublished manuscript . Peru . International and Public Affairs , Unpublished manuscript . Working paper # ï?? , prepared for the Biodiversity Action P ï쳌¡ ï쳌² ï쳌¤ ï쳌¯ M.P . ï?? ï?? ï?? ï?? a . Biodiversidad : Análisis normativo y de Network . competencias para Colombia . Instituto Humboldt . Legis ï쳌¤ ï쳌® ï쳌° . ï?? ï?? ï?? ï?? . Política Nacional de Biodiversidad , Colombia . Editores , Colombia . Departamento Nacional Planeación , Colombia . P ï쳌¡ ï쳌² ï쳌¤ ï쳌¯ M.P . ï?? ï?? ï?? ï?? b . Compilación y análisis normativo sobre F ï쳌¥ ï쳌² ï쳌² ï쳌¥ ï쳌© ï쳌² ï쳌¡ P . and M.P . P ï쳌¡ ï쳌² ï쳌¤ ï쳌¯ . ï?? ï?? ï?? ï?? . Estrategia de Colombia propiedad intelectual . Unpublished manuscript . Instituto frente a la negociación de la Estrategia Andina en Humboldt . Colombia . Biodiversidad . Documento de Soporte Técnico , Informe S ï?¡ ï쳌® ï쳌£ ï쳌¨ ï쳌¥ ï쳌º E . , M.P . P ï쳌¡ ï쳌² ï쳌¤ ï쳌¯ , M . F ï쳌¬ ï쳌¯ ï쳌² ï쳌¥ ï쳌³ , and P . F ï쳌¥ ï쳌² ï쳌² ï쳌¥ ï쳌© ï쳌² ï쳌¡ . ï?? ï?? ï?? ï?? . Final . Unpublished manuscript . Comunidad Andina de Protección del conocimiento tradicional . Elementos Naciones , Ministerio de Medio Ambiente de Colombia . conceptuales para una propuesta de reglamentación â?? El F ï쳌¡ ï쳌® ï쳌¤ ï쳌© ï?± ï쳌¯ , M.C . and P . F ï쳌¥ ï쳌² ï쳌² ï쳌¥ ï쳌© ï쳌² ï쳌¡ M ï쳌© ï쳌¡ ï쳌® ï쳌© ( eds . ) . ï?? ï?? ï?? ï?? . Colombia caso de Colombia . Unpublished manuscript . Instituto Biodiversidad Siglo XXI . Propuesta técnica para la for - Humboldt . Colombia . mulación d un Plan de Acción Nacional en Biodiversidad . Instituto Humboldt , Ministerio del Medio Ambiente , and ï쳌µ ï쳌® ï쳌¥ ï쳌° / ï쳌£ ï쳌¢ ï쳌¤ . ï?? ï?? ï?? ï?? . Convention on Biological Diversity . Departamento Nacional Planeación , Colombia . ï쳌µ ï쳌® ï쳌¥ ï쳌° / ï쳌£ ï쳌¢ ï쳌¤ / ï?? ï?? / ï?? . ï쳌µ ï쳌² ï쳌¬ : http : / / www.biodiv.org / convention / ï쳌§ ï쳌´ ï쳌º / ï쳌¦ ï쳌µ ï쳌® ï쳌¤ ï쳌¥ ï쳌£ ï쳌¯ / ï쳌© ï쳌¥ . ï?? ï?? ï?? ï?? . Acceso a recursos genéticos â?? articles.asp . Documento preliminar para revisión por parte de los Endnotes 1 The Andean Community , a subregional organization endowed to develop a special regime or norm to strengthen the protection with an international legal status , is made up of Bolivia , Ecuador , of traditional knowledge , innovations , and practices , as a stated in Venezuela , Peru and Colombia . Decision ï?? ï?? ï?? on ï쳌¡ ï쳌¢ ï쳌³ . 2 8 The institute is linked to the ï쳌­ ï쳌¯ ï쳌¥ and is in charge of promoting , Access is defined in Decision ï?? ï?? ï?? as the obtainment and utilization coordinating and undertaking research leading to the conservation of genetic resources conserved in ex situ or in situ conditions , of and sustainable use of Colombiaâ??s biodiversity . their derivatives , or , if it is the case , of its intangible components , with the purpose of research , bioprospecting , conservation , indus - 3 The National Planning Department is the central government office trial application , or commercial use , among others . responsible for designing and setting economic , social and environ - 9 mental policies in coordination with other ministries and territorial Genetic resources are defined in Decision ï?? ï?? ï?? as all material of entities . biological nature that contains genetic information of real or poten - tial value or usefulness . 4 Separate sections will be used to describe and analyze policies 10 and laws related to ï쳌¡ ï쳌¢ ï쳌³ due to the different nature and intent of Derivative product is defined by Decision ï?? ï?? ï?? as molecules or these two instruments . Biodiversity related policies in Colombia a combination of natural molecules , including crude extracts of are aimed at providing an orientation and defining actions from living or dead organisms of biological origin , coming from the government and also from civil society regarding the conservation metabolism of living beings . and sustainable use of biological resources . One of their main pur - 11 Intangible component is defined by Decision ï?? ï?? ï?? as every knowl - poses is to group efforts from diverse societal interests regarding edge , innovation , or practice , whether individual or collective , with biodiversity . On the other hand , legislation defines rules that have real or potential value associated with the genetic resource , their the force of authority by virtue of their promulgation by an official derivative products , or the biological resource that contains them , branch of the state or other organizations . Even though laws and whether protected or not by intellectual property regimes . norms are set in a policy environment , they do not replace policies ; 12 The ï쳌­ ï쳌¯ ï쳌¥ can not delegate any functions to the Regional they are mere policy instruments . Corporations , either on this or any other topic . Nevertheless , it can 5 Further information is available in the Andean Community web make agreements with the Corporations to undertake supervision page at : http : / / www.comunidadandina.org . responsibilities under Decision ï?? ï?? ï?? Article ï?? ï?? or to participate in 6 Since there is no official follow up on the implementation of the the process as National Support Institutions . ï쳌® ï쳌¢ ï쳌° or the ï쳌® ï쳌¢ ï쳌³ ï쳌¡ ï쳌° a precise report on their accomplishments can - 13 No other laws or regulations have been formulated to facilitate the not be provided . The information offered is largely based on the implementation of Decision ï?? ï?? ï?? . Decree ï?? ï?? ï?? of ï?? ï?? ï?? ï?? modifies consultantâ??s assessment and knowledge of the latest developments . and renders null several previous regulations affecting scientific 7 As will be explained below , the Andean Community has agreed biodiversity research . ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ 14 23 Before promulgation of the Decree , separate permits were required Sociedad Peruana de Derecho Ambiental , a Peruvian think tank . for the activities that the decree regulates , often provided by 24 This proposal was elaborated with the representation of indigenous diverse environmental authorities . The unification under a unique organizations , Afro - Colombian communities , ï쳌® ï쳌§ ï쳌¯ s , Academic permit considerably simplifies the legal requirements for scientific Centers , and central and regional government institutions . research on biological resources . 25 In fact , Law ï?? ï?? of ï?? ï?? ï?? ï?? states that Colombia has the right of eco - 15 National support institution is defined by Decision ï?? ï?? ï?? as a person nomic compensation for the use of its genetic resources . or national legal entity dedicated to technical or scientific biologi - 26 Decision ï?? ï?? ï?? has not been necessarily an obstacle to access activi - cal research that accompanies the access applicant and participates ties and research initiatives . They continue to take place without in the access activities . All access contracts requests must include the required access contracts . the identification of the person or national support institution . Also , 27 A.M . Hernández , ï쳌­ ï쳌¯ ï쳌¥ , pers . comm . ï?? February ï?? ï?? ï?? ï?? . national support institutions must be approved by the ï쳌® ï쳌£ ï쳌¡ . 28 16 This problem is augmented in the Andean case due to the nature of Access resolution is defined by Decision ï?? ï?? ï?? as the administrative Andean Decisions , which do not require going through congress act issued by the ï쳌® ï쳌£ ï쳌¡ that perfects the access to genetic resources before their adoption . This minimizes the debate , even though it and their derivative products , after having complied with all the may prevent a prolonged interest - oriented political debate . prerequisites and conditions established in the access procedure . 29 17 This difficulty may have appeared due to the nature of Andean Nevertheless , the ï쳌­ ï쳌¯ ï쳌¥ has not developed monitoring procedures . negotiations that require the travel of numerous negotiators around 18 Synthesized products are defined by Decision ï?? ï?? ï?? as substances the five Andean countries , increasing costs of meetings , etc . obtained by means of an artificial procedure from genetic informa - 30 Articles ï?? ï?? , ï?? ï?? ï?? # ï?? ï?? , ï?? ï?? ï?? # ï?? ï?? . These articles are about ï쳌© ï쳌° ï쳌² in tion or from other biological molecules . It includes semi - processed general ; they are not specific to biodiversity . extracts and substances obtained from a derivative product by an 31 artificial process . These articles relate to traditional arts , rural industries , and health 19 issues related indirectly to ï쳌© ï쳌° ï쳌² s . It only indicates that the ï쳌® ï쳌£ ï쳌¡ will evaluate the request and will 32 undertake the necessary inspections . This article is about the functions of the ï쳌­ ï쳌¯ ï쳌¥ regarding access to 20 genetic resources , including the function given to the Ministry with Even though there is no government charge for the presentation of respect to the rights of the nation over its genetic resources . the access application , there are transaction costs involved due to 33 the legal requirements and the length of the process . These transac - These articles are about technology transfer to local , indigenous and tion costs have not been calculated . Afro - Colombian communities ( Article ï?? ) , and about the protection 21 of traditional knowledge associated with genetic resources and the A.M . Hernández , ï쳌­ ï쳌¯ ï쳌¥ , pers . comm . , ï?? February ï?? ï?? ï?? ï?? . need to have prior informed consent before its use ( Article ï?? ) . 22 Colombian negotiators supported the ï쳌¦ ï쳌¡ ï쳌¯ International Treaty on 34 This article indicates the functions of the â?? permanent agreement Plant Genetic Resources for Food and Agriculture and used the ï쳌£ ï쳌¢ ï쳌¤ table â?쳌 , including the adoption of principles , criteria , and proce - and Decision ï?? ï?? ï?? to back up their negotiation position . Colombia dures concerning protection of indigenous collective knowledge has not signed the treaty yet , and it has not been debated yet what related to biodiversity and genetic resources ; it also discusses and the relationship with Decision ï?? ï?? ï?? will be . In fact the ï쳌­ ï쳌¯ ï쳌¥ and the develops Humboldt Institute are currently researching this issue , which is unclear due to the supra national nature of Decision ï?? ï?? ï?? . ï?? ï?? ï?? 5 Costa Rica : Legal Framework and Public Policy Jorge Cabrera - Medaglia Access to genetic resources and the distribution of benefits based on the existing legal norms , access to Costa Ricaâ??s resources and knowledge should comply with the follow - were two of the most controversial topics debated in the ing requirements : development of the Convention on Biological Diversity ( ï쳌£ ï쳌¢ ï쳌¤ ) . The sustainable use of genetic resources by means â?¢ Obtain prior informed consent ( î?© î?? î?? ) from the of bioprospecting or other forms of economic utilization State and other stakeholders , including owners of ( R ï쳌¥ ï쳌© ï쳌¤ et al . ï?? ï?? ï?? ï?? ) represents for many an important prom - traditional knowledge or biological , genetic , and ise to obtain economic benefits while insuring biodiversity biochemical resources . conservation and the well being of local communities and â?¢ Include sharing of benefits generated from access indigenous peoples . Articles ï?? and ï?? ï?? of the ï쳌£ ï쳌¢ ï쳌¤ have to biodiversity and traditional knowledge by means reaffirmed countries â?? sovereignty over their own genetic of agreements or contracts that broadly embrace resources and the right to regulate and facilitate access to â?? mutually agreed terms â?쳌 . those resources for environmentally sound uses . This has â?¢ Promote biodiversity conservation and capacity imposed upon countries , especially suppliers , an enormous building aimed at adding value to each countryâ??s responsibility . natural resources . This chapter provides basic information on the Costa Rican experience in the matter of access to genetic re - These requirements do not deal only with control - sources , distribution of benefits , and establishment of sui ling the access to biological , genetic , and biochemical generis systems . In it I will examine and share the les - resources . They deal with the fact that ( in compliance sons and merits of the Costa Rican process of adoption with the prevailing regulatory standards ) the traditional and implementation of the Costa Rican national Law of knowledge , innovations , and practices of local communi - Biodiversity . ties and indigenous peoples must also be protected in the The biological wealth in the tropical countries of our countries of our region . Modern societies acknowledge region and the alternatives for using genetic and bio - that for centuries most indigenous peoples have developed chemical resources and traditional knowledge constitute their own agricultural systems , practices and knowledge , a day - by - day reality . The advances achieved in relation plague - fighting methods , handling of natural resources , to organism exploration techniques and the feasibility of and traditional medicine and that this knowledge is un - â?? new biotechnologies â?? have opened the doors to a new doubtedly valuable and useful for those in other sectors of vision of the â?? hidden â?? values of our resources and tradi - society who are not the intellectual creators and developers tional knowledge . Frequently , we hear about the interest of those practices . of agrochemical , seed , and pharmaceutical companies For many years , biological diversity , traditional works in carrying out research using our natural wealth and aimed at improving animal life and cultivation , and in - traditional knowledge in their investigations . However , digenous knowledge involved in these activities were ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ considered a public good and a â?? Common Heritage of wealth without granting any compensation . This concept Mankind â?쳌 . Nevertheless , based on the genetic resources stated that biological diversity was considered the common freely obtained , a great variety of natural products were heritage of mankind ; that is , it was declared a public good developed such as new vegetable varieties , pharmaceutical and no payment should be made for its use . Naturally , products , and pesticides , which were classified as private pesticides , medicines , and improved seeds belong to the property and subject to intellectual property rights ( î?? î?© î?« s ) private sector and were not affected by this concept . ( basically , plant breeders â?? rights , patents , and trade se - Simultaneous with the rising international conscious - crets ) . In this way , natural products based on free genetic ness rejecting the concept of the common heritage of man - resources were available at a high cost for developing kind , the advance of modern biotechnology ( such as the countries . The asymmetry of this relationship between recombining of î?? î?? î?? and cellular fusion ) are advances in genetic resources that were freely provided by the South the field of microelectronic technical screening of biologi - and the final products using those resources that could only cal materials that have strengthened the interest of many be acquired at a certain price from the companies of the pharmaceutical , chemical , and biotechnology companies North should have been justified in some manner . and seed producers in the wild or domesticated genetic This asymmetry resulted from the application of a con - resources and traditional knowledge of indigenous peoples cept that allows for the extraction of our countries â?? genetic and local communities . Identification of Relevant Access Laws and Policies scope , the procedure for prior informed consent ( î?© î?? î?? ) , Key Features of Laws and Policies and mutually agreed terms , competent authority , distribution Current Status of Implementation . of benefits , and sanctions . Some relevant topics such as the need to distinguish between access with agricultural or The national legislation that regulates access to genetic pharmaceutical purposes or between research with com - material , biochemical resources , and traditional knowledge mercial or academic purposes and the need of prompt and for the whole country is the Law of Biodiversity ( î?? î?? ) , special mechanisms for ex situ collections were scarcely No . ï?? ï?? ï?? ï?? of ï?? ï?? April ï?? ï?? ï?? ï?? . Before the enactment of this considered . These areas constitute some of the deficiencies law , there were some provisions in the Law of Wildlife of the legislation that must be corrected with appropriate Conservation ( î?? î?¶ î?? ) No . ï?? ï?? ï?? ï?? of ï?? ï?? October ï?? ï?? ï?? ï?? regard - regulations . ing flora and fauna collection permits . There were also The î?? î?? , whose application and interpretation still re - some bylaws dealing with research , specifically referring mains uncertain in several areas , sets up the basis for access to national parks . No modern regulations on agricultural permits and contracts . The law contains clear definitions on materials existed at the time . Currently , there is a General crucial topics ( î?? î?? Article ï?? ) such as access to biochemical Access Procedure ( î?? î?? î?© ) in place that will function as a and genetic elements , bioprospecting , î?© î?? î?? , innovation , and bylaw of the î?? î?? . The î?? î?? î?© was approved on ï?? ï?? December access permits . Likewise , it has clarified the genetic and ï?? ï?? ï?? ï?? by the Minister of Environment and Energy and the biochemical resources property regime by stating that these President through an executive decree . The î?? î?? î?© was pro - resources belong in the public domain to be managed by posed by the National Commission for the Management of the State ( î?? î?? Article ï?? ) . Also , two types of properties were Biodiversity ( î?? î?¡ î?? î?? î?? î?? î?? î?? î?¡ ) in conformity with î?? î?? Article ï?? ï?? distinguished : that of the biological or organic resource with the participation of personnel of the National System 1 and that of the genetic and biochemical resource . of Conservation Areas ( î?¬ î?? î?? î?? î?? ) , universities , nongovern - According to î?? î?? Article ï?? ï?? ï?? , the law has been fully mental organizations ( î?? î?? î?¡ s ) , and industry . in force since its publication in April ï?? ï?? ï?? ï?? . However , an In relation to access policies , there is a National action to declare this law unconstitutional was brought by Biodiversity Strategy that contemplates a set of actions 2 theAttorney Generalâ??s Office . This claim was admitted for to be taken in the area of access to genetic resources . study by the Constitutional Chamber ( Unconstitutionality Additionally , there is a National Environmental Policy Action Number ï?? ï?? - ï?? ï?? ï?? ï?? ï?? ï?? - ï?? ï?? ï?? - î?? î?¡ - î?? , admitted by draft ( Conservation and Sustainable Development October ï?? ï?? ï?? ï?? Resolution ) . According to Articles ï?? ï?? and Strategy ) that includes biodiversity as one of its compo - ï?? ï?? of the Law of the Constitutional Jurisdiction No . ï?? ï?? ï?? ï?? , nents , in particular the topic of access to genetic resources the suit does not suspend the execution of the î?? î?? . However , and distribution of benefits . Finally , î?¬ î?? î?? î?? î?? concluded a from the political point of view it has definitely delayed National Research Strategy that would be applicable to implementation of î?? î?¡ î?? î?? î?? î?? î?? î?? î?¡ . its officials and to joint ventures between î?¬ î?? î?? î?? î?? officials This action was brought specifically against î?? î?? Articles and officials from other entities wishing to access genetic ï?? ï?? and ï?? ï?? . In relation to access , Article ï?? ï?? is of supreme resources for research purposes . importance . It creates the î?? î?¡ î?? î?? î?? î?? î?? î?? î?¡ , one purpose of During the development of the î?? î?? , a series of topics which is to define the national policies for biodiversity , were considered for the formulation of the dispositions including access to genetic resources . The chapters dealing relative to access , distribution of benefits , and protection of traditional knowledge . These included basic definitions , with access to genetic resources ( procedural and substan - ï?? ï?? ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : C ï쳌¯ ï쳌³ ï쳌´ ï쳌¡ R ï쳌© ï쳌£ ï쳌¡ tive aspects ) have not been questioned . As a consequence , These exceptions ( î?? î?? Article ï?? ) refer fundamentally to access to human genetic resources and the exchange of ge - if the action succeeds it would only affect the legal com - netic and biochemical resources that are part of traditional petencies of î?? î?¡ î?? î?? î?? î?? î?? î?? î?¡ in this matter , not the remainder practices of indigenous peoples and local communities and of the applicable dispositions . that have a commercial purpose . In addition , public univer - The Ministry of Environment and Energy ( î?? î?? î?? î?? î?? ) con - sities were exempted from control for a term of one year sidered these legal competencies unconstitutional ; thus ( until ï?? May ï?? ï?? ï?? ï?? ) in order for them to establish their own the Ministry requested the Attorney General to submit a controls and regulations for noncommercial projects that constitutional challenge . Fundamentally , the following require access . Apart from this , all the remaining sectors powers have been questioned : ( pharmaceutical , agriculture , biotechnology , ornamental , â?¢ î?? î?¡ î?? î?? î?? î?? î?? î?? î?¡ â?? s legal authority to formulate national and medicinal herbs ) are subject to the î?? î?? and must follow policies and to coordinate them ( clauses ï?? , ï?? , ï?? , ï?? , its access procedures . There is only one access procedure and ï?? of î?? î?? Article ï?? ï?? ) and its authority to exhaust to be followed by all users . The î?? î?? î?© regulates access for the administrative route in case of challenges commercial and noncommercial bioprospecting ( including presented against the resolutions of the Technical teaching ) , occasional economic utilization , constant use of Office ( î?® î?¡ ) of the Commission ( clause ï?? of î?? î?? genetic and biochemical resources , and traditional knowl - Article ï?? ï?? ) . In both cases this would run counter edge . The law indicates that a concession will be required to the exclusive power of the Executive Branch in in case of access to genetic resources for commercial use , these areas . without defining steps or requirements . â?¢ Independent management of public funds ( as pro - The î?? î?? is applied equally to genetic agricultural re - vided by î?? î?? Articles ï?? ï?? and ï?? ï?? ) , running counter sources . It establishes the possibility of fixing , by means to Articles ï?? ï?? ï?? , ï?? ï?? ï?? , and ï?? ï?? ï?? of the Constitution . of a separate regulation , the procedures for access permits to the ex situ collections duly registered before the î?® î?¡ of As indicated , the constitutional challenge , although not î?? î?¡ î?? î?? î?? î?? î?? î?? î?¡ ( î?? î?? Article ï?? ï?? ) . To a great extent , access to ge - preventing the implementation of the regulations , has had netic agricultural resources is realized by means of ex situ the effect of slowing down many of the necessary decisions collections , though in Costa Rica there are some requests to make the law operational . For example , the î?? î?¡ î?? î?? î?? î?? î?? î?? î?¡ to make use of agricultural resources found in situ . was not put into effect until January ï?? ï?? ï?? ï?? , almost two years The î?? î?? foresees specifically that in the case of duly later than initially foreseen by the law . Equally , there is a registered ex situ collections , the regulation of the law legitimate concern that if the action succeeds , î?? î?¡ î?? î?? î?? î?? î?? î?? î?¡ â?? s will set the authorization procedure for access permits role could turn out to be that of a simple adviser and not ( î?? î?? Article ï?? ï?? ) . It would include any type of collection . a public policy maker . To date , the action has not been 3 The above - mentioned procedure was supposed to be de - resolved by the Constitutional Chamber . termined by means of the î?? î?? î?© . However , the draft still does not have rules on this point . On the contrary , the Scope of the LB , Exceptions and Specific î?? î?? î?© establishes a moratorium on the access to genetic Treatment for Some Sectors resources found in ex situ conditions , unless the specific The legislation is applied â?? â?¦ on the elements of the bio - regulations are approved . The î?? î?? î?© provided six months diversity under the Stateâ??s sovereignty , as well as on the for the drafting of these regulations . These regulations are processes and the activities carried out under its jurisdic - especially complex due to the institutional structures that tion or control , independently of whether the effects of keep genetic resources in ex situ conditions . Furthermore , the actions are manifested inside or outside the national other applicable dispositions to ex situ collections can be jurisdiction â?쳌 . The î?? î?? will regulate specifically the use , found in different regulations , without direct relation to ac - management , associated knowledge , and distribution cess , but in relation to conservation and maintenance ( e.g . , of benefits and costs derived from the utilization of the see the decree of creation of the National Commission of elements of the biodiversity ( î?? î?? Article ï?? ) . î?? î?? Article ï?? Plant Genetic Resources , No . ï?? ï?? ï?? ï?? ï?? - î?? î?? î?? of ï?? September establishes that â?? The biochemical and genetic properties ï?? ï?? ï?? ï?? and the Law of Seeds No . ï?? ï?? ï?? ï?? of ï?? December ï?? ï?? ï?? ï?? of the components of biodiversity , wild or domesticated , and its bylaw ) . There is no official record of the ex situ belong to the public domain . The State will authorize collections in the country . the exploration , research , bioprospecting , and use of the As mentioned , the î?? î?? applies to all the elements of components of biodiversity which constitute part of the biodiversity found under the sovereignty of the State ( î?? î?? public domain , as well as the utilization of all the genetic Article ï?? ) and to all basic research and commercial bio - and biochemical resources , by means of the rules of access prospecting projects conducted in Costa Rican territory ( î?? î?? established in chapter î?µ of this law . â?쳌 Also , in conformity Article ï?? ï?? ) . In this respect , access regulations are applied with î?? î?? Articles ï?? ï?? and ï?? ï?? , every research program or bio - to genetic resources in public or private land , terrestrial prospecting effort on genetic material carried out in Costa or marine environments , ex situ or in situ collections , and 4 Rican territory requires an access permit , unless covered indigenous territories . Nevertheless , there are some omis - by one of the exceptions foreseen by the î?? î?? . sions relative to resources in marine areas . Hence , other ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ legal rules can be applicable to obtain access to these bio - î?? î?? . The î?® î?¡ will grant or deny access requests ( î?? î?? Article logical resources . Specifically , the Costa Rican Institute of ï?? ï?? , clause a ) ; coordinate access issues with conservation Fishing and Aquaculture ( î?? î?? î?? ) is the entity entrusted with areas , the private sector , indigenous peoples , and rural granting fishing licenses , including research permits , but communities ( î?? î?? Article ï?? ï?? , paragraph b ) ; organize and excluding permits for resources found in marine regions of keep an updated record of access requests and ex situ wild protected areas ( Law of Creation of î?? î?? î?? No . ï?? ï?? ï?? ï?? of collections , as well as a record of the individuals and ï?? ï?? March ï?? ï?? ï?? ï?? , Article ï?? and Attorney Generalâ??s Opinion legal entities that devote themselves to genetic manipula - î?? - ï?? ï?? ï?? - ï?? ï?? of ï?? ï?? September ï?? ï?? ï?? ï?? ) . In this case , access tion ( paragraph c ) ; and compile and update regulations permits by the î?® î?¡ are also required . Regarding access to relative to the fulfillment of its agreements and directives indigenous land there are other applicable laws , besides ( paragraph d ) . the î?? î?? , such as the Convention on Indigenous Peoples of The î?® î?¡ has not been established due to lack of bud - the International Labor Organization and the rules of the get , personnel , constitutional action , and political will . sui generis system of intellectual community rights that Nevertheless , î?? î?¡ î?? î?? î?? î?? î?? î?? î?¡ â?? s budget in ï?? ï?? ï?? ï?? was ï?? ï?? ï?? ï?? , ï?? ï?? ï?? are being developed through a consultation process that î?° î?¬ î?? , which allowed for the establishment of an Executive began recently . Director and some support personnel such as a secretary , a technician , an attorney , and a bookkeeper . î?? î?¡ î?? î?? î?? î?? î?? î?? î?¡ â?? s activities are regulated by means of Monitoring Mechanisms î?? î?? î?? î?? î?? decree No . ï?? ï?? ï?? ï?? ï?? , published in The Gazette of The î?? î?? creates a self - governed î?? î?¡ î?? î?? î?? î?? î?? î?? î?¡ ( î?? î?? Article ï?? August ï?? ï?? ï?? ï?? , and its modifications . Its members are ï?? ï?? ) as a separate legal entity , but belonging to the î?? î?? î?? î?? î?? . designated for a two - year period . The Commissionâ??s î?? î?¡ î?? î?? î?? î?? î?? î?? î?¡ â?? s duties include : To formulate the policies and responsibilities include granting of access permits and responsibilities established in î?? î?? chapters î?? î?µ , î?µ , and î?µ î?? . implementation of monitoring and evaluation procedures . Furthermore , it has to coordinate these policies with the To date , evaluation and monitoring procedures have not relevant institutions . Additionally , it has to formulate and been carried out because of the lack of implementation coordinate the policy for access to elements of biodiversity of î?? î?? . Due to absence of human and technical resources , and associated knowledge , ensuring a suitable transference it is improbable that these monitoring procedures will be of science and technology , as well as the distribution of implemented in the short run . Probably , those who under - benefits , which are general procedures under Title î?µ of take the access procedure will be subject to monitoring for the î?? î?? . the obligations assumed under the î?© î?? î?? agreement and the î?? î?¡ î?? î?? î?? î?? î?? î?? î?¡ will execute its agreements and resolutions î?® î?¡ â?? s resolution approving their access permit . and will design its internal procedures by means of its î?® î?¡ â?? s Executive Director ( î?? î?? Article ï?? ï?? ) . The composition Evaluation of Commercial and of î?? î?¡ î?? î?? î?? î?? î?? î?? î?¡ is set forth in î?? î?? Article ï?? ï?? : î?? î?? î?? î?? î?? , which Noncommercial Bioprospecting Initiatives presides over it , the Ministries of Agriculture , of Health , According to î?? î?? Article ï?? ï?? ( characteristics and condi - and of Foreign Trade , î?¬ î?? î?? î?? î?? , î?? î?? î?? , the National Small tions of access permits ) , the access requirements will be Farmers Board , the National Indigenous Peoples Board , determined differently depending on whether the research National Council of Rectors , the Costa Rican Federation has or does not have a commercial purpose . In the latter for the Conservation of the Environment ( î?? î?? î?? î?¡ î?? ) , and the case , the noncommercial purpose will have to be verified . Costa Rican Union of Chambers of Commerce . î?? î?? î?¡ s are Nevertheless , the î?? î?? î?© does not contemplate different re - represented by î?? î?? î?? î?¡ î?? . The National Biodiversity Institute quirements for bioprospecting projects with commercial ( î?? î?? î?? io ) is not a member of the î?? î?¡ î?? î?? î?? î?? î?? î?? î?¡ . and noncommercial purposes in spite of the fact that î?? î?? î?© In addition , î?? î?¡ î?? î?? î?? î?? î?? î?? î?¡ must formulate policies on Article ï?? ( permits for basic research ) establishes that if access and distribution of benefits . It can also revoke the a project has commercial purposes , the interested party î?® î?¡ â?? s resolutions regarding access matters ( î?? î?? Article ï?? ï?? ) . will have to fulfill additional requirements . In general , In conformity with î?? î?? Article ï?? ï?? , î?? î?¡ î?? î?? î?? î?? î?? î?? î?¡ must propose there is no clarity on the form this distinction would take . policies on access to genetic and biochemical resources of This issue has been a constant in the critiques of diverse ex situ and in situ biodiversity . It will also act as an obliga - regulations and reports , as in the case of The Philippines â?? tory consultant in procedures related to the protection of Executive Order on Bioprospecting , as well as in the con - î?? î?© î?« s on biodiversity . clusions of the î?? î?? î?? â?? s Experts Panel on Access to Genetic The Executive Director will appoint î?? î?¡ î?? î?? î?? î?? î?? î?? î?¡ â?? s î?® î?¡ , as well as other personnel indicated in the regulation of the Resources . ï?? ï?? ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : C ï쳌¯ ï쳌³ ï쳌´ ï쳌¡ R ï쳌© ï쳌£ ï쳌¡ Main Characteristics of the Law of Biodiversity about the process , requirements , and length of time needed Main Steps Outlined by the LB to obtain this concession ( Figure ï?? ) . The î?? î?? regulates the basic requirements for access , includ - First , in conformity with access procedure norms , in - ing the î?© î?? î?? , transfer of technology , equitable distribution terested parties must register with the î?® î?¡ using a specific of benefits , the protection of associated knowledge , and form ( î?? î?? Article ï?? ï?? ) . Later , the î?© î?? î?? must be negotiated the definition of the ways in which the above - mentioned in conformity with a guide which stipulates the minimal activities will contribute to the conservation of species points for discussion ( î?? î?? Article ï?? ï?? ) between the appli - and ecosystems . It also mandates the designation of a cant and owner of the conservation area or indigenous legal representative in the country , when the person or land , resources , or ex situ collections . This would include organization requesting access is domiciled abroad ( î?? î?? not only individuals , but other government entities such Article ï?? ï?? ) . The procedure to follow is clearly outlined in as municipal governments , the Agrarian Development î?? î?? Article ï?? ï?? . It includes proof of the î?© î?? î?? of the owner of Institute , and the î?? î?? î?? . the property where the activity will be developed , whether The î?© î?? î?? is supposed to contain mutually agreed - upon it is an indigenous community , a private owner , or public terms that represent the fair and equitable distribution of entity . Other interesting provisions incorporate the right of benefits . Once obtained , this agreement must be endorsed cultural objection ( î?? î?? Article ï?? ï?? ) , the registry of access ap - by the î?® î?¡ . Even though the legislation is not clear , it is plications , and the protection of confidential information , assumed that the î?© î?? î?? will be formalized in a private con - except in the case of biosafety concerns ( î?? î?? Article ï?? ï?? ) . tract . The î?® î?¡ limits itself to endorsing the contract rather The î?? î?? also regulates in detail commercial and non - than negotiating it . The î?® î?¡ â?? s approval authorizes three commercial bioprospecting permits ( Article ï?? ï?? ) . These fundamental aspects : the î?© î?? î?? â?? s fulfillment of the require - are valid for three years and can be renewed . They are ments established in the Technical Guide , the number of given to specific persons or entities and are therefore not samples to be taken , and the time frame for the reports to transferable . The permits are limited to the genetic and be presented ( î?? î?? Article ï?? ï?? ) . biochemical elements expressly authorized for specific A request form and completed Technical Guide ( î?? î?? areas or territories ( î?? î?? Article ï?? ï?? ) . The permits will con - Article ï?? ) must be submitted to the î?® î?¡ . In both cases there tain a certificate of origin , permission or prohibition to are requirements and documents that must be presented extract samples , periodic reporting obligation , monitoring jointly . Additionally , the documents established in î?? î?? î?© and control , conditions relative to resulting property , and Article ï?? ï?? must be attached . Additional requirements any another applicable condition deemed relevant by the are established for those who request permits for basic î?® î?¡ ( î?? î?? Article ï?? ï?? ) . research or bioprospecting ( î?? î?? î?© Article ï?? . ï?? ) and for those The access request requirements are name and iden - who need access permits for occasional or continuing eco - tification of the interested party , name and identification nomic utilization ( î?? î?? î?© Article ï?? . ï?? ) . of the responsible researcher , exact location of the place , î?? î?? Article ï?? ï?? requires a determination of the admin - and the elements of biodiversity that will be the subject istrative fee . The î?? î?? î?© also refers to this payment ( î?? î?? î?© of the investigation , indicating the owner and manager Article ï?? ï?? on administrative rates ) . After the î?® î?¡ extends a or holder of the premises . The applicant will also have to certificate of origin ( î?? î?? î?© Article ï?? ï?? ) , it proceeds to publish submit a descriptive chronology of activities , aims , and the requests and final resolutions on its website within eight purposes as well as place for legal notifications . The ap - calendar days ( î?? î?? î?© Article ï?? ï?? ) . plication must be accompanied by the î?© î?? î?? ( î?? î?? Article ï?? ï?? ) Once access is authorized , the monitoring and control and a record of individuals or legal entities who are to phase begins ( î?? î?? î?© Article ï?? ï?? ) at the expense of the î?® î?¡ conduct the bioprospecting ( î?? î?? Article ï?? ï?? ) . The î?® î?¡ must and in coordination with the authorized representatives also authorize those agreements contemplating access to of the place where access to the resources is taking place . genetic and biochemical elements ( î?? î?? Article ï?? ï?? ) signed Applicants will have to follow applicable sanitary and 5 between individuals , natives , or foreigners , or between phytosanitary rules for the exportation of the materials . them and the institutions registered for such purposes . In case of ex situ collections , special rules may be es - There is also a possibility to establish framework agree - tablished allowing framework agreements that authorize ments with universities and other duly authorized centers the transfer of multiple materials . In such cases Material ( î?? î?? Article ï?? ï?? ) . It is established that up to ï?? ï?? % of the Transfer Agreements would have to be duly standardized research budget and ï?? ï?? % of royalties will have to go to the and approved by the î?® î?¡ . The î?® î?¡ â?? s resolutions can be re - conservation area , the private owner , or indigenous com - voked or appealed by the î?? î?¡ î?? î?? î?? î?? î?? î?? î?¡ ( î?? î?? î?© Article ï?? ï?? ) . munity ( î?? î?? Article ï?? ï?? ) . In cases in which the î?® î?¡ authorizes Finally an environmental impact assessment ( î?? î?? î?? ) can the continuing use of genetic material or of biochemical be requested by the î?® î?¡ based on some general provisions extracts for commercial purposes , applicants are required of the î?? î?? related to î?? î?? î?? , but not specific to bioprospecting to obtain a separate concession from the interested party activities ( î?? î?? Article ï?? ï?? ) . The evaluation is the responsibil - ( î?? î?? Article ï?? ï?? ) . There are no further guidelines in the î?? î?? ity of the National Technical Secretariat ( a body of î?? î?? î?? î?? î?? ) . ï?? ï?? ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ sional , without any further specifications and î?? î?? Article To date no î?? î?? î?? has been requested of î?? î?? î?? io or any other bioprospector . ï?? ï?? allows î?? î?¡ î?? î?? î?? î?? î?? î?? î?¡ to name ad hoc expert committees At this early stage the approximate duration of the in complex cases . above procedures is unknown . The current system is In any case , the current scheme would leave the ne - based on the î?? î?¶ î?? No . ï?? ï?? ï?? ï?? of ï?? ï?? October ï?? ï?? ï?? ï?? and its gotiation of contracts ( by means of the î?© î?? î?? ) , in the hands regulation No . ï?? ï?? ï?? ï?? ï?? - î?? î?? î?? î?? î?? of ï?? December ï?? ï?? ï?? ï?? , as well of the managers of conservation areas and eventually of as permits for flora and wildlife collection ( î?? î?¶ î?? Article other public authorities , insofar as they are the owners of ï?? ï?? and subsequent articles ) . These collection permits are the lands or of the biological resources . granted by î?¬ î?? î?? î?? î?? after the submission of an administrative form and a consultation in the conservation area where the Characteristics of the Access research and collection will take place . This procedure is Requirements relatively simple and takes approximately one month for The procedures for access are not completely clear , espe - processing . cially under the î?? î?? î?© . On the other hand , the requirements Up to now , î?¬ î?? î?? î?? î?? has had only five full - time employ - are clearly established in Articles ï?? ï?? and ï?? ï?? of the î?? î?? , ees , untrained in the topic of the bioprospecting agree - as well as in the î?? î?? î?© â?? s Articles ï?? to ï?? ï?? . Only the î?® î?¡ and ment negotiations . Research permits are being granted eventually the î?? î?¡ î?? î?? î?? î?? î?? î?? î?¡ shall grant access permits . A by the î?¬ î?? î?? î?? î?? Director . î?? î?? Article ï?? ï?? establishes that the separate î?© î?? î?? should be obtained from other entities such Executive Director of the î?® î?¡ must be a suitable profes - ï?? . A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ P ï쳌¥ ï쳌² ï쳌­ ï쳌© ï쳌´ ï쳌³ ( Articles ï?? , ï?? . ï?? , ï?? . ï?? ï?? , and ï?? ï?? ) ï?? . Framework â?¢ Basic research ( Article ï?? ï?? Agreements â?¢ Bioprospecting ( Article ï?? ï?? ) ( Article ï?? ï?? ) â?¢ Economic use : constant and occasional ( concessions ) ( Article ï?? ï?? ) ï?? . Contracts with Third Parties Prior authorization STATE required for the FIRST STAGE Technical Office ( Articles ï?? ï?? , ï?? ï?? , ï?? ï?? , REGISTRY OF APPLICANTS CONAGEBIO ï?? ï?? , and ï?? ï?? ) ( Articles ï?? ï?? . ï?? and ï?? ï?? . ï?? ) Technical Office A ï쳌° ï쳌° ï쳌¬ ï쳌© ï쳌£ ï쳌¡ ï쳌® ï쳌´ ï쳌³ ( Articles ï?? ï?? . ï?? and ï?? ï?? . ï?? ) â?¢ Individuals and legal entities ( Article ï?? . ï?? ï?? ) â?¢ Research centers ( Article ï?? ï?? ) ( Art . ï?? ï?? . ï?? ) APPROVAL SECOND STAGE APPLICATION ( Art . ï?? ï?? ) AND TECHNICAL GUIDE WHICH INCLUDES : THIRD PRIOR INFORMED CONSENT ( Articles ï?? and ï?? ) STAGE AND MUTUALLY AGREED TERMS ( Articles ï?? ï?? and ï?? ï?? ) REGIONAL COUNCIL OF LOCAL COMMUNITY EX SITU COLLECTIONS CONSERVATION AREAS AUTHORITY ( Articles ï?? ï?? and ï?? ï?? ) INDIGENOUS LAND AUTHORITY OWNER FOURTH STAGE : MONITORING Figure ï?? . Access procedure . ï?? ï?? ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : C ï쳌¯ ï쳌³ ï쳌´ ï쳌¡ R ï쳌© ï쳌£ ï쳌¡ as conservation areas , indigenous territories or public au - the autonomy or cultural identity of peoples and communities . thorities who are owners of lands , or , in the case of marine resources , other authorities such as î?? î?? î?? . â?¢ Strategic genetic resources or geographical areas In this respect , access to flora and fauna found on qualified as such . private lands would eventually need other authorizations â?¢ The prohibition of access for military purposes or from state entities like the î?? î?? î?? î?? î?? , particularly in cases of for denaturalization of the resources . species in danger of extinction or with reduced popula - tions . Access would be granted in conformity with the Relationship to Other Laws technical and scientific arrangements stated by î?¬ î?? î?? î?? î?? . In theory it is possible to foresee some reforms to other Thus , even if the flora were in private lands ( e.g . , orchids ) , national laws as a result of new access regulations . Reforms the î?¬ î?? î?? î?? î?? would give the permits for the manipulation of to the Patent Law may be made to include the presenta - the resource ( î?? î?¶ î?? No . ï?? ï?? ï?? ï?? , Articles ï?? ï?? , ï?? ï?? , and ï?? ï?? and tion of the certificate of origin in cases where an invention its regulation No . ï?? ï?? ï?? ï?? ï?? , Article ï?? ï?? . ) . In such a case it is using genetic resources or traditional knowledge is being not clear whether there should be a double authorization : patented . Some similar regulations may be necessary in from the î?® î?¡ for the genetic resource and from the î?¬ î?? î?? î?? î?? the Plant Breeders â?? Rights draft that is currently being for the biological one , as well as the landlordâ??s consent discussed in the LegislativeAssembly . Eventually , the î?? î?? â?? s regarding private property . dispositions on patentability exclusions ( Article ï?? ï?? ) might In cases where collections are made in conservation be integrated with the Law of Patents ( see below ) . areas , the î?© î?? î?? and the respective agreement are enough to Some laws that govern asssccess to biological resourc - obtain the access permit . The main difficulties arise when es , such as î?? î?¶ î?? or Law of the î?? î?? î?? , might be reformed to there is a question of privately owned wild , threatened establish the necessary coordination between the access flora . permit to genetic resources and the access permit to bio - All interested parties can access genetic and biochemi - logical resources ( wild flora and fauna are in some cases cal resources . Nevertheless , î?? î?? î?© â?? s Article ï?? ï?? establishes marine resources ) , with the intention of simplifying the the following â?? Criteria for the evaluation or approval of steps and respective procedures to obtain access . the request â?쳌 based on the public environmental interest The laws relative to customs control ( General Customs criteria embodied in the î?? î?? ( Article ï?? ï?? . ï?? ) : Law No . ï?? ï?? ï?? ï?? of ï?? November ï?? ï?? ï?? ï?? ) and the export of sani - â?¢ Development options for future generations ; tary or phytosanitary material ( Phytosanitary Protection â?¢ Food safety and sovereignty ; Law ) , could be reformed to include a clause like the one stated by Decision ï?? ï?? ï?? ( Common Regime on Access to â?¢ Conservation of ecosystems ; Genetic Resources of the Andean Community ) , which â?¢ Protection of human health ; expressly mentions that the authorization to export bio - â?¢ Improvement of citizens â?? quality of life ; logical material does not imply the authorization for the â?¢ Gender issues ; and use of the genetic component ( Fourth Complementary Disposition ) . There could be a need to reform the â?¢ î?? î?© î?« s not affecting key agricultural products and Phytosanitary Protection Law as it deals with other top - processes for the nourishment and health of the ics such as biosafety . countryâ??s inhabitants . This criterion also includes protection for the resources of local communities and indigenous populations . Provisions that Promote the Conservation of Biodiversity , its Sustainable Use , and Also , î?? î?? î?© â?? s Article ï?? ï?? allows the imposition of total or partial restrictions on access to the resources to ensure the Fair Sharing of Benefits Derived from their conservation and sustainable use . These restrictions Biodiversity are issued by the î?® î?¡ in the resolution approving access . In this way , it can prohibit access , set limits , and regulate The î?? î?? was designed to implement the î?? î?? î?? in Costa Rica . the methods of collection , in application of the precaution - î?? î?? Articles ï?? ï?? , ï?? ï?? , and ï?? ï?? are of paramount importance ary principle mentioned in î?? î?? â?? s Article ï?? ï?? . ï?? . To establish in access to genetic resources . The î?? î?? established that , complete or partial restrictions some of the elements that without prejudice to the fulfillment of regulations rela - tive to the trade of endangered species of flora and fauna , will be considered are : the application of sanitary and phytosanitary measures â?¢ The danger of extinction of the species , subspecies , and technical procedures and biosafety , the disposition races , and varieties . on access to genetic resources will constitute neither a â?¢ Reasons of scarcity and endemic conditions . concealed restriction nor an obstacle to trade ( î?? î?? Article â?¢ Vulnerability or fragility conditions in the structure ï?? ï?? , general rule of interpretation ) . There are also similari - or function of the ecosystems . ties between î?? î?? and other laws such as the î?? î?¶ î?? , the Law â?¢ Adverse effects on human health , the species , of the î?? î?? î?? , the Law of Phytosanitary Protection No . ï?? ï?? ï?? ï?? and the ecosystems or on essential elements of and its regulation No . ï?? ï?? ï?? ï?? ï?? - î?? î?? î?? , and the Convention on ï?? ï?? ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ International Trade of Endangered Species , Law No . ï?? ï?? ï?? ï?? tions the transfer of technology and equitable distribution of ï?? ï?? October ï?? ï?? ï?? ï?? . of benefits , the protection of associated knowledge , and the The general goal of the î?? î?? is to promote the conser - definition of the ways in which the projectâ??s activities will vation and sustainable use of biodiversity and to ensure contribute to the conservation of species and ecosystems . the fair and equitable sharing of benefits derived from it Other regulations mentioned in î?? î?? Article ï?? ï?? also contain ( Article ï?? ) . The entire î?? î?? responds to this goal as put forth parameters for distribution of benefits . All monetary and by the î?? î?? î?? . For example , it establishes the environmental nonmonetary benefits to be distributed are not listed but function of the land ( Article ï?? ) , general principles of the a generic rule is set forth with some specific indications law ( Article ï?? ) , objectives ( Article ï?? ï?? ) , criteria for apply - regarding royalties , operation budget ( Article ï?? ï?? ) , and ing the law ( Article ï?? ï?? ) , î?¬ î?? î?? î?? î?? â?? s administrative structure technology transfer ( Articles ï?? ï?? and ï?? ï?? ) . ( including the administration of the national wild protected There are no binding requirements that benefits must areas , Articles ï?? ï?? to ï?? ï?? ) , the guarantee of environmental go towards the conservation of the resources . It is per - safety ( biosafety and exotic organisms , Articles ï?? ï?? to ï?? ï?? ) , fectly possible that a private owner , public institution , or the conservation and the sustainable use of the ecosystems indigenous territory could grant the î?© î?? î?? without allocating and species ( Articles ï?? ï?? to ï?? ï?? ) , the regulations on access benefits towards conservation since the legal authority of to genetic resources ( Articles ï?? ï?? to ï?? ï?? ) , î?? î?© î?« s ( Articles ï?? ï?? the î?® î?¡ is limited to endorsement . In these circumstances , it to ï?? ï?? ) , education and public awareness and research and is valid to ask whether the î?® î?¡ would have the legal authority transfer of technology ( Articles ï?? ï?? to ï?? ï?? ) , environmental to revoke a previous consent because of a lack of benefits impact assessment ( Articles ï?? ï?? to ï?? ï?? ) , incentives ( Articles towards conservation derived from the access ( Article ï?? ï?? ) . ï?? ï?? to ï?? ï?? ï?? ) , and procedures and sanctions ( Articles ï?? ï?? ï?? As one might expect , in those cases in which a conservation to ï?? ï?? ï?? ) . All of these elements are in accordance with the area grants the permits , it is assumed that the benefit will three objectives of the î?? î?? î?? . Specifically relating to access , î?? î?? Article ï?? ï?? also men - go in its entirety towards biodiversity conservation . Analysis of the Process that Led to the Development of the LB The formulation process of the î?? î?? and the discussion of parties ( National Liberation and Social Christian Unity ) , matters related to access , the protection of associated the Advisory Commission on Biodiversity ( î?? î?¡ î?? î?? î?? î?¡ ) , the knowledge , and î?? î?© î?« s are particularly relevant . The first National Small Farmers Forum , the National Indigenous draft of the î?? î?? was developed in ï?? ï?? ï?? ï?? . It generated a nega - Forum , the Union of Chambers for Private Business , the tive reaction from different stakeholders that considered it University of Costa Rica ( with two representatives ) , the to be especially restrictive and opposed to both the public National University ( with two representatives ) , î?? î?? î?? î?¡ î?? , good and scientific research . Multiple suggestions were and î?? î?? î?? io . The group was composed of twelve represen - made to the Legislative Assembly , including a complete tatives and their alternates , named by sectors including new draft prepared by the Advisory Commission on the nongovernmental sector , representatives of indigenous Biodiversity which was never formally incorporated by peoples and farmers , the private sector , the academic the legislative course ( C ï쳌¡ ï쳌¢ ï쳌² ï쳌¥ ï쳌² ï쳌¡ M ï쳌¥ ï쳌¤ ï쳌¡ ï쳌§ ï쳌¬ ï쳌© ï쳌¡ ï?? ï?? ï?? ï?? ) . sector , and the government ( by means of the Advisory The second draft of the law appeared in January ï?? ï?? ï?? ï?? . Commission on Biodiversity ) . The Special Commission Even though this draft considered several of the objec - met until December ï?? ï?? ï?? ï?? when the new draft was sent to tions made to the first draft , it also repeated several of the the Parliament . It received the favorable opinion of the concepts and dispositions stated by the first version of the Parliamentâ??s Commission on Environment , and after minor document . Therefore , it met with the same opposition . This modifications , the text was finally adopted as law . It was situation led to the creation of a Special Commission in published in The Gazette , the Official Diary , in May ï?? ï?? ï?? ï?? the Legislative Assembly . Its mandate was to create a new and entered into force as law of the republic the same year . draft , taking into consideration the old one . The Assembly As mentioned before this was comprehensive legislation promised to respect the outcome . and access was only one of the topics covered . No foreign The Commission , led by the National University , consultants participated in this process . was installed in April ï?? ï?? ï?? ï?? . It included the main political ï?? ï?? ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : C ï쳌¯ ï쳌³ ï쳌´ ï쳌¡ R ï쳌© ï쳌£ ï쳌¡ Main Difficulties and Successes Experienced During the Design of the LB The most controversial aspects of the process can be sum - vented an understanding of real difficulties found elsewhere . marized in the following points : â?¢ There was a need for both open discussion on topics â?¢ There was disagreement about the access process of national interest that affect many different inter - and the entity entrusted with granting the permits ested parties and eliminating the habit of deciding and authorizations . Diverse sectors thought that the these issues by a small group . current system , with authorizations granted by the î?¬ î?? î?? î?? î?? , was inappropriate and should have had a â?¢ Due to the fact that the main policy aspects of wider representation . It was alleged that the î?¬ î?? î?? î?? î?? â?? s the negotiation were included in the law , while close relationship to î?? î?? î?? io might put the permits the operative aspects were deferred to the by - into question . These groups argued that the creation laws ( due to the representative character of the of a wider Commission to deal with access and Legislative Assembly versus the regulatory duty related topics ( e.g . , National Biodiversity Strategy of the Executive Power ) , the drafting process dealt and î?? î?? î?? negotiations ) , integrated with diverse sec - with the main topics and their complexities without tors , would propitiate a more suitable space and reference to a discussion of the regulations . greater credibility concerning the control of the The most troubling points were solved through a state over genetic resources . process of negotiation , but due to time constraints to â?¢ The public character of the genetic resources made achieve an agreement , many of the points were sent to them subject to a public property regime , indepen - the Parliamentâ??s Plenary without a final resolution . On dent of private ownership of the land where they the other hand , some of the most controversial aspects , were located , and created legal consequences to such as î?? î?© î?« s , were strongly debated by the business and the rights of applicants of access . academic representatives in a Special Subcommittee in â?¢ î?® î?¡ â?? s approval of contracts and agreements that charge of drafting the law . Other aspects , such as the î?? î?? î?? io had previously signed with national and public character of genetic resources and the existence of foreign companies created problems which will a î?? î?¡ î?? î?? î?? î?? î?? î?? î?¡ , were accepted , under different proposals . be described later in this report . For example , the î?? î?¡ î?? î?? î?? î?? î?? î?? î?¡ would work through a î?® î?¡ composed of government employees who would make the â?¢ The integration of procedures regarding intellec - legal decisions , with power of review at the expense of the tual property with the procedures of the î?? î?? , since Commission . In order to ensure the TOâ??s independence , a diverse exclusions have been established ( Article maximum self - government statute was granted to it . ï?? ï?? ) , needs to be accomplished . The compatibility Some of the patentability exclusions were eliminated of some of these exclusions with the Agreement and others remained , in spite of warnings on their pos - on Trade Related Aspects of Intellectual Property sible unconstitutionality . Finally , the public character Rights ( î?® î?« î?? î?© î?¬ ) is debatable . of the resources was accepted . This point still provoked â?¢ There was opposition between those who consid - protest and review by representatives of the farmers â?? sec - ered access as a way of legitimizing biopiracy and tor , who even considered the possibility of asking for a those who , on the contrary , were defending the hearing by the Department of Technical Services of the mechanism as a way to promote the sustainable Parliament . Eventually , this Department decided to reject use of the genetic and biochemical resources . this submission . â?¢ The î?? î?? involved wide public participation in its Although the access process was simplified in relation design process , a necessity in a matter affecting to the first proposal , some of the most controversial dis - the activities and interests of many sectors . The positions were kept , such as the î?® î?¡ â?? s power of reviewing law functioned as a comprehensive initiative to deal contracts with third parties ( î?? î?? Article ï?? ï?? ) . Some of the with different challenges imposed by the î?? î?? î?? , such difficulties and incongruities that became apparent after as access , technology transfer , ex situ and in situ approval , were problems that had been pointed out by the conservation , biosafety , environmental impact as - members of the î?? î?¡ î?? î?? î?? î?? î?? î?? î?¡ during the drafting process sessment , education , and public awareness . of the î?? î?? î?© . â?¢ There was a lack of information and participation by some groups such as indigenous communities , Main Obstacles to the Completion of the LB peasants , and private sectors , who were only able to express their points of view in relation to cer - There was a lack of information on access . In spite of the tain specific issues . It became clear that capacity fact that some members of the Commission had experience building in the design of these legal frameworks in the matter , several of the interested sectors were only is critical . The lack of sufficient information on able to formulate very general positions that did not include comparable international experiences also pre - the range of topics that access entails . Some academic , ï?? ï?? ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ indigenous , rural , and entrepreneurial sectors , as well as Probably one of the most relevant elements of the elabo - political party representatives , made general statements , ration process was the opportunity granted to different but when the moment for deeper technical debates arose , interested groups , such as the indigenous populations and these stakeholders were not prepared to make concrete farmers , to take part in the negotiating process . It was propositions . an exercise on how processes work in reality , especially There were time limitations for completing the draft in those cases in which opposite points of view exist . of law and sending it to the Legislative Assembly . Due to Additionally , this procedure allowed a real exercise of time constraints imposed by Parliamentary procedures for environmental democracy in a strategic area of national approval of laws and the need to submit a final text , topics development . were sent to the Parliamentâ??s Plenary . This prevented a There were internal difficulties within participating real discussion of the some of the most controversial and stakeholder groups . During the negotiation several propos - relevant aspects . als and issues arose on which representatives had to consult The legislation needed to be comprehensive . Since the their constituencies . For example , the representatives of the î?? î?? covered the multiple mandates expressed by the î?? î?? î?? , the industry sector stated that they would not vote for any of possibility of dedicating sufficient time and effort to access the proposals but would limit themselves to taking part in to genetic resources was diminished due to the need to the debates of the Commission , since they were incapable finalize a comprehensive draft ( more than ï?? ï?? ï?? articles ) . Stakeholder involvement was of primary importance . of negotiating on behalf of all their associates . Identification and Analysis of the Difficulties and Successes in the Implementation of the LB In spite of the fact that the î?? î?? was adopted in ï?? ï?? ï?? ï?? , it has In ï?? ï?? ï?? ï?? , î?? î?? î?? io developed the concept and practice of not been implemented due to the action of unconstitutional - â?? bioprospecting â?쳌 as one of the answers to the need for ity filed against it . Neither have the positions within the î?® î?¡ the sustainable use of Costa Rican biodiversity to benefit nor access procedures that would function as regulations society . This concept , which refers to the systematic search of the law been created . For this reason there have been for new biological sources of chemical compounds , genes , no requests . Informally , several access requests have been proteins , microorganisms , and other products that pos - submitted , but none have been processed or resolved . sess a current economic value or potential , continues to The informal requests made to date are : gain acceptance in government , scientific , academic , and managerial circles . The use of the biodiversity presents â?¢ University of Wisconsin , Madison requested the opportunities and challenges to promote and to organize right to gather wild potato material in some areas the infrastructure investments and human resources that of the Bi - National Park â?? La Amistad â?쳌 . This group add value and contribute to its conservation . withdrew their request since they could not get any î?? î?? î?? io has a formal agreement with î?? î?? î?? î?? î?? , which allows response from Panama where they also wanted to carrying out specific activities related to the identification collect . and use of biodiversity in the governmentâ??s protected areas . â?¢ The Firenze Institute , Italy requested access to î?? î?? î?? io actively develops biodiversity prospecting in the pro - â?? Cyanobacterias â?쳌 . Only a preliminary document tected wild areas of the country under that agreement , with was submitted and no follow - up communications the participation of the national and international academic were obtained . and private sector . Research is carried out in collabora - â?¢ The National University requested access to wild tion with research centers , universities , and national and material of the Sechium genus in some protected international private companies , by means of research areas and in an ex situ collection . The response is agreements that include key elements , such as : pending . â?¢ Access that is limited in time and quantity . To date , the requests involving bioprospecting , namely â?¢ Equity and compensation . those of î?? î?? î?? io , are dealt with in accordance with the coop - â?¢ Research budget . eration agreement between î?? î?? î?? io and the î?? î?? î?? î?? î?? , and with â?¢ Benefit sharing . regard to conservation areas , by means of the î?? î?¶ î?? . â?¢ Technology transfer . â?¢ Nondestructive activities . Bioprospecting Projects The agreements also called for up - front payment 6 for conservation . They specify that ï?? ï?? % of the research INBioâ??s Biodiversity Prospecting Program budgets and ï?? ï?? % of the future royalties shall be donated î?? î?? î?? io was created in ï?? ï?? ï?? ï?? as a nongovernmental and to î?? î?? î?? î?? î?? to be reinvested in conservation ( Table ï?? ) . The nonprofit association . Its mission is to promote a new research budget supports the scientific infrastructure in awareness of the value of biodiversity in order to achieve its conservation and use it to improve the quality of life . the country , as well as activities of added value aimed at ï?? ï?? ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : C ï쳌¯ ï쳌³ ï쳌´ ï쳌¡ R ï쳌© ï쳌£ ï쳌¡ conservation and sustainable use of biodiversity . Until now lished . This project concluded its activities in Costa Rica by the middle of ï?? ï?? ï?? ï?? . no royalties have been paid nor has any product reached the market , but there are some products under development , INBio - British Technology Group ( BTG ) - Ecos La Pacífica particularly in the ornamental and herbal areas . Agreement . In the agricultural area , î?? î?? î?? io seeks to integrate the result of bioprospecting activity with the economic INBio Agreements with Industry development of the country . This process began with the A brief summary of the most outstanding research agree - signing of the î?? î?? î?? io - î?? î?® î?? agreement in ï?? ï?? ï?? ï?? that allowed ments to date including the benefits accrued to î?? î?? î?? io is î?? î?? î?? io to begin the research into characterization of and as follows : production of a chemical compound with nematicidal INBio - Merck Agreement : Search for Sustainable Uses of activity known as î?? î?? î?? î?© that was derived from a tree of the Costa Rican Biodiversity . Signed in October ï?? ï?? ï?? ï?? , this the Costa Rican dry tropical forest ( Lonchocarpus felipei ) . was the first agreement with a commercial company to Parallel investigations have been developed jointly with search for sustainable uses of Costa Rican biodiversity with the corporation Ecos La Pacífica , aimed at determining the potential for the pharmaceutical industry and veterinary growing conditions of the species and the production of science . It was renewed in ï?? ï?? ï?? ï?? , ï?? ï?? ï?? ï?? , and ï?? ï?? ï?? ï?? upon the î?? î?? î?? î?© , as well as the effectiveness of this nematicide similar terms and expired in ï?? ï?? ï?? ï?? . The agreement covered in tropical crops . The greenhouse and field trials began in the study of a limited number of extracts of plants , insects , ï?? ï?? ï?? ï?? and continue being carried out to date with satisfac - and environmental samples to determine their potential tory results . î?? î?® î?? has paid a small amount of money to both use . The agreement has given î?? î?? î?? io access to technology , î?? î?? î?? io and Ecos La Pacifica due to the licensing of a patent technical expertise , and training . related to the î?? î?? î?? î?© use . Chemical Prospecting in a Costa Rican Conservation INBio - Diversa Agreement : Search for Enzymes from Area . This project began in ï?? ï?? ï?? ï?? and ended in September Extremophilic Organisms with Applications to the ï?? ï?? ï?? ï?? . It is one of the five International Cooperative Chemical Industry . For the exploration of new enzymes Biodiversity Groups ( î?? î?? î?? î?? s ) financed by three units in the in aquatic or terrestrial microorganisms of Costa Rican î?° î?¬ î?? : the National Institutes of Health ( î?? î?? î?? ) , the National biodiversity under extreme conditions , î?? î?? î?? io signed a Science Foundation , and the Department of Agriculture . research agreement with Diversa Corporation in ï?? ï?? ï?? ï?? . It was located in the Guanacaste Conservation Area and This agreement was renewed in ï?? ï?? ï?? ï?? and ï?? ï?? ï?? ï?? , and it was carried out in collaboration with the University of will expire in ï?? ï?? ï?? ï?? . It involves the gathering of bacteria Costa Rica , Cornell University , and Bristol Myers Squibb . in different conservation areas of Costa Rica that will be Its objectives were to incorporate tropical insects in the studied for the identification and isolation of new enzymes search for new pharmaceutical products and to increase useful in industry . The agreement also guarantees the the capacity of human resources in the fields of ecology , training of Costa Rican scientists in collection methods , taxonomy , and ecochemistry . isolation , and molecular biology , specifically in cloning and characterization of genes associated with enzymes . A INBio - Givaudan Roure Agreement : Fragrances and third negotiation is currently being carried out . Aromas . In ï?? ï?? ï?? ï?? , as a result of the constant search for new options , î?? î?? î?? io began an association with the com - INBio - Indena S.p.A . Agreement : Search for Compounds pany Givaudan Roure to explore potential fragrances and with Antimicrobial and Antiviral Activity . With the objec - aromas from Costa Rican biodiversity . These fragrances tive of obtaining compounds with antimicrobial potential and aromas were taken directly from the air surround - to be used as active ingredients in cosmetics , î?? î?? î?? io and ing fragrant objects in the forest . The objective was to the phytopharmaceutical company Indena S.p.A . , with determine the feasibility of new products from volatile headquarters in Milan , Italy signed a collaboration agree - compounds in Costa Rican biodiversity and to promote ment in ï?? ï?? ï?? ï?? , with a second phase that started in ï?? ï?? ï?? ï?? technology transfer in this area . A royalty rate was estab - and concluded in ï?? ï?? ï?? ï?? . Extracts of selected plants were Table ï?? . Contributions made to biodiversity conservation in Costa Rica as a result of bioprospecting agreements signed by î?? î?? î?? io with various organizations from ï?? ï?? ï?? ï?? until ï?? ï?? ï?? ï?? . All values in $ î?° î?¬ î?? . Organization ï?? ï?? ï?? ï?? * ï?? ï?? ï?? ï?? ï?? ï?? ï?? ï?? ï?? ï?? ï?? ï?? ï?? ï?? ï?? ï?? ï?? ï?? ï?? ï?? ï?? ï?? ï?? ï?? ï?? ï?? ï?? ï?? Total î?? î?? î?? î?? î?? by ï?? ï?? % ï?? ï?? ï?? , ï?? ï?? ï?? ï?? ï?? , ï?? ï?? ï?? ï?? ï?? , ï?? ï?? ï?? ï?? ï?? , ï?? ï?? ï?? ï?? ï?? , ï?? ï?? ï?? ï?? ï?? , ï?? ï?? ï?? ï?? ï?? , ï?? ï?? ï?? ï?? ï?? , ï?? ï?? ï?? ï?? ï?? ï?? , ï?? ï?? ï?? Conservation areas ï?? ï?? , ï?? ï?? ï?? ï?? ï?? ï?? , ï?? ï?? ï?? ï?? ï?? ï?? , ï?? ï?? ï?? ï?? ï?? ï?? , ï?? ï?? ï?? ï?? ï?? ï?? , ï?? ï?? ï?? ï?? ï?? , ï?? ï?? ï?? ï?? ï?? ï?? ï?? ï?? , ï?? ï?? ï?? Costa Rican ï?? ï?? ï?? , ï?? ï?? ï?? ï?? ï?? ï?? , ï?? ï?? ï?? ï?? ï?? , ï?? ï?? ï?? ï?? ï?? , ï?? ï?? ï?? ï?? ï?? , ï?? ï?? ï?? ï?? ï?? , ï?? ï?? ï?? ï?? , ï?? ï?? ï?? ï?? , ï?? ï?? ï?? ï?? ï?? ï?? , ï?? ï?? ï?? public universities Other groups in î?? î?? î?? io ï?? ï?? ï?? , ï?? ï?? ï?? ï?? ï?? , ï?? ï?? ï?? ï?? ï?? ï?? , ï?? ï?? ï?? ï?? ï?? ï?? , ï?? ï?? ï?? ï?? ï?? ï?? , ï?? ï?? ï?? ï?? ï?? ï?? ï?? ï?? ï?? , ï?? ï?? ï?? Total ï?? ï?? ï?? , ï?? ï?? ï?? ï?? ï?? ï?? , ï?? ï?? ï?? ï?? ï?? ï?? , ï?? ï?? ï?? ï?? ï?? ï?? , ï?? ï?? ï?? ï?? ï?? ï?? , ï?? ï?? ï?? ï?? ï?? , ï?? ï?? ï?? ï?? ï?? , ï?? ï?? ï?? ï?? ï?? , ï?? ï?? ï?? ï?? , ï?? ï?? ï?? , ï?? ï?? ï?? * Estimated amounts since ï?? ï?? ï?? ï?? . ï?? ï?? ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ evaluated in bioassays to determine their antimicrobial University of Costa Rica Research Center of Parasitology , activity . The final process is carried out by Indena . two plants were studied to isolate active components against malaria . This project built upon the encouraging INBio - Phytera Inc . Agreement . Traditionally , drugs have results of the î?? î?? î?? î?? project . been developed from extracts of leaves , roots , bark , and Also , in collaboration with the Unit of Electronic other parts of plants . Today , with the advances in biotech - Microscopy , the Laboratory of Biological Assays , and the nology , medicines can be derived from cell cultures , and National Childrenâ??s Hospital , these plants were validated new techniques can create a variety of chemical substances for gastritis treatment by their anti - Helicobacter pylori from these cultures . In ï?? ï?? ï?? ï?? , î?? î?? î?? io signed an agreement activity . Finally , some species were validated by their al - with this company , which continued in effect until the kaloid content to explore their economic feasibility . This year ï?? ï?? ï?? ï?? . project was implemented between ï?? ï?? ï?? ï?? and ï?? ï?? ï?? ï?? . INBio - Eli Lilly Agreement : Search for New Compounds . The Chagas Project . î?? î?? î?? io , together with î?? î?? î?« î?® î?? , the This project started in ï?? ï?? ï?? ï?? and concluded in ï?? ï?? ï?? ï?? . It was National University of Costa Rica , other Latin American carried out in collaboration with the pharmaceutical com - institutions of Brazil , Mexico , Chile , Argentina , Uruguay , pany Eli Lilly and Co . with an objective of searching for and î?? î?? î?¬ î?? in the United States , are part of â?? The Chagas botanical compounds with pharmaceutical application . Space Project â?쳌 , a research project that is looking for a so - INBio - Akkadix Corporation Agreement : Search for lution to one of the most serious health problems of Latin Compounds with Nematicidal Activity . This project was America : the Chagas disease orAmerican Tripanosomiasis . carried out with the company Akkadix Corporation from î?? î?? î?? io carried out some research activities on plants with ï?? ï?? ï?? ï?? to ï?? ï?? ï?? ï?? . Its main objective was the search for alterna - inhibitory activity towards the disease in ï?? ï?? ï?? ï?? . In ï?? ï?? ï?? ï?? , tives for the control of nematodes . the î?° î?¬ î?? Congress approved a fund dedicated to refinance this project which has allowed resumption of the bioassays . INBio Agreements with Academia The project was renewed in ï?? ï?? ï?? ï?? . These research agreements of an academic nature with INBio - Inter - American Development Bank ( IDB ) national and international universities vary considerably Agreement : Program for Support of the Development of in their focus , but they are all guided toward the solution the Use of Biodiversity by Small Enterprises . In February of problems and the search for knowledge and products . ï?? ï?? ï?? ï?? , î?? î?? î?? io signed an agreement with the î?? î?? î?? with the INBio - University of Strathclyde Agreement . This agree - purpose of formalizing the terms of a technical cooperation ment allows access to new technologies and methodolo - grant to support the development of the use of biodiversity gies . The University of Strathclyde , UK also facilitates by small companies . The project is likely to expire in ï?? ï?? ï?? ï?? ; interaction between î?? î?? î?? io and the Japanese private sector . however , in the first phase of the project , six projects were î?? î?? î?? io provided a limited number of extracts of plants that approved : were evaluated during a limited time by several industries â?¢ Agrobiot S.A : Propagation of Costa Rican tropi - of that country . This agreement was implemented between cal plants to be commercialized as eco - educational ï?? ï?? ï?? ï?? and ï?? ï?? ï?? ï?? . souvenirs ( started in ï?? ï?? ï?? ï?? ) ; INBio - University of Massachusetts Agreement : Search for â?¢ Laboratorios Lisan S.A : Pharmaceutical products Potential Insecticides . Through a collaboration with the based on medicinal plants ( started in ï?? ï?? ï?? ï?? ) ; University of Massachusetts , USA , with the support of î?? î?? î?? , â?¢ La Gavilana : Development of a model of eco - this joint venture carried out research to find compounds friendly practices for vanilla production ( started with insecticidal activity . This project began in October of in ï?? ï?? ï?? ï?? ) ; ï?? ï?? ï?? ï?? and concluded in ï?? ï?? ï?? ï?? . Its objective was the devel - â?¢ Industrias Caraito S.A : Generation of added value opment of enzymatic bioassays of extracts derived from on the carao agro - industry ; plants , insects , bryophytes , and mollusks . â?¢ Bougainvillea S.A : Research for development and INBio - University of Guelph Agreement : Development production of a biocide from Quassia amara wood ; of New Technologies for Medicines Based on Plants , an and International Interdisciplinary Initiative . This agreement â?¢ Follajes Ticos S.A : Native ornamental plants with is being carried out with the University of Guelph , Canada . market potential . It was signed in ï?? ï?? ï?? ï?? and will conclude in ï?? ï?? ï?? ï?? . Its main objective is the search for new pharmaceutical products Negotiation of Selected Access Requests . through techniques such as plant tissue culture . In access negotiations with companies , î?? î?? î?? io has taken the Other Agreements most active role , so it has learned a great deal from the Validation of Promising Plants . This project was financed process . The State has limited its participation to granting by the Costa Rican î?° î?¬ î?? Foundation . It contemplated three collection permits through the î?¬ î?? î?? î?? î?? in accordance with subprojects that allowed obtaining information to improve the quality of life of Costa Ricans . In collaboration with the the î?? î?¶ î?? and the Cooperation Agreements with î?? î?? î?? io . ï?? ï?? ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : C ï쳌¯ ï쳌³ ï쳌´ ï쳌¡ R ï쳌© ï쳌£ ï쳌¡ In this section I would like to establish the lessons â?¢ The existence or the development of institutional learned from the process of negotiating agreements and capacity for the negotiations in legal , scientific , contracts , based on the experiences of î?? î?? î?? io . Several and business areas ) is a necessity . The terms of the publications have been written ( G ï?¡ ï쳌­ ï쳌¥ ï쳌º and S ï쳌© ï쳌´ ï쳌´ ï쳌¥ ï쳌® ï쳌¦ ï쳌¥ ï쳌¬ ï쳌¤ agreements are often challenging and complex . ï?? ï?? ï?? ï?? ) concerning the structure , policies , and programs of â?¢ Innovation and creativity add considerable weight î?? î?? î?? io . In general , significant experiences in benefit shar - to compensation and benefit - sharing negotia - ing have been obtained since the signing of the agreement tions . with Merck and Co . in ï?? ï?? ï?? ï?? . These , and other contractual â?¢ Mastering of key issues is crucial : î?? î?© î?« s , warranties , relationships , have resulted in the following benefits : determination of royalty rates , transfer of materials â?¢ Monetary benefits by means of direct payments ; to third parties , definitions ( products and extracts ) , â?¢ Payment for specific samples ; ownership of î?? î?© î?« s , joint research , confidentiality , â?¢ Coverage of research budgets ; dispute resolution , and the survival of obligations . These are some of the key issues that are negotiated â?¢ Transfer of important technology that has allowed with bioprospectors . the development of infrastructure in î?? î?? î?? io is the laboratory of biotechnology , which has been used â?¢ Proactive approaches to business development for research and development of local products ; according to the needs of the country and a de - fined institutional policy ( biodiversity prospecting â?¢ Capacity - training for scientists and technicians , in strategy ) enhance the opportunities for new and relation to state - of - the - art technologies ; innovative agreements . The existence of a Business â?¢ Experience in market negotiations , knowledge , Development Office at î?? î?? î?? io with a highly qualified and research for finding more intelligent uses of expert staff ; attending seminars and activities with biodiversity resources ; the industry the distribution or sharing of informa - â?¢ Support of conservation efforts by means of pay - tion and material , and direct contacts all enable an ments to î?? î?? î?? î?? î?? to strengthen the National System answer to be given , to a larger or smaller extent , of Conservation Areas ; to institutional challenges . The current policy is â?¢ Transfer of equipment to other institutions , such as based on the idea that it is not enough to wait to the University of Costa Rica ; be contacted , or to be available at the behest of â?¢ Future royalties and milestone payments , which the company , but one must assertively have and will be shared on a ï?? ï?? - ï?? ï?? basis with î?? î?? î?? î?? î?? ; and maintain oneâ??s own approach . Even if no formal â?¢ Creation of national skills in order to add value to market survey has been made , the identification of biodiversity resources . potential partners in the field of biotechnology has been developed . According to my experience as î?? î?? î?? ioâ??s legal adviser , the â?¢ Coordination with other national and international lessons learned by î?? î?? î?? io in access negotiations are as institutions devoted to biodiversity R & D and under - follows : standing of technology transfer needs and capacity â?¢ It is essential to have a defined institutional policy building at the country level are important require - on the requirements and criteria to be included in ments in the process . the biodiversity prospecting agreements . â?¢ Good political support , an appropriate legal frame - â?¢ The national scientific capacity facilitates adding work , and legal certainty ( e.g . , who is entitled to value to biodiversity resources and enhances the grant permits ) create a positive environment for countryâ??s position in the negotiation of benefits to success . be incorporated in the contract ( e.g . , higher royalty rates ) . â?¢ The development of macro - policies such as national biodiversity inventories , information management â?¢ It is necessary to develop a good understanding of systems , investment in science and technology , and the operation and evolution of biodiversity mar - well - defined protected areas provide a smoother kets and to be aware of the technical and scientific changes that support them . scenario for biodiversity prospecting . ï?? ï?? ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ The Role of the LB in Hampering or Facilitating Access to the Countryâ??s Genetic Resources Although this role cannot be precisely defined due to the budget or controversies may arise in relation to the scope lack of application of the î?? î?? , several difficulties , includ - of the language . For example , does the budget include 8 ing the lack of clarity of certain clauses , the obscure and sampling and export costs ? complex system proposed by the î?? î?? î?© , the lack of qualified The approval of third - party contracts also raises personnel versed in the functioning of the genetic resources several doubts . In this case we would be in the presence market , the terms of the contracts and agreements , the of intermediaries or joint research agreements involving absence of practical experience in the applicability of the foreign counterparts . In this example , the contracts have law and the time it will take to enforce it , and certain sec - been previously signed . Should the î?® î?¡ limit itself to en - tors â?? resistance to new rules for the academy and research , dorsement , given its inability to examine the negotiation suggest a difficult future for bioprospectors . For instance , process ? In this state of affairs , under which criteria can some provisions of the î?? î?? may actually prevent access . the î?® î?¡ disapprove the contract , perhaps an insufficient 9 The legislation is not clear in relation to the î?® î?¡ â?? s pow - technology transfer ? ers . The î?® î?¡ has to endorse the î?© î?? î?? and , according to the î?? î?? î?© , Should the authorization process be initiated before the some other functions are bestowed upon it ( î?? î?? Article ï?? ï?? , procedure for getting the prior informed consent is started ? authorization of the number of samples to obtain or export Or , which seems more logical , should both procedures be and the periodicity of the activity reports ; î?? î?? Article ï?? ï?? , initiated at the same time ? It is obvious that the applicant control and follow - up activities , etc . ) . Notwithstanding this negotiates its relationship with the owner based on the fact , the î?® î?¡ does not have the power to negotiate access fact that the î?® î?¡ â?? s approval is pending . This can create terms with the applicant , since it can only endorse them uncertainties for the negotiators since the î?® î?¡ can eventu - without the possibility of modifying them . This literal read - ally request further requirements that would have to be ing of the î?? î?? î?© creates some difficulties . For example , what distributed between the applicant and the company . happens if there is no third party from whom to obtain Confidentiality is a little obscure . Article ï?? ï?? states physical access ? If a university possesses its own ex situ that the procedure should follow Articles ï?? ï?? , ï?? ï?? , and ï?? ï?? . resources and wants to make use of those resources in ( This is another argument in favor of the simultaneity in 7 bioprospecting the î?© î?? î?? prescribed in articles ï?? ï?? , ï?? ï?? , and the third - party contract approval and the presentation of ï?? ï?? of the law and in the î?? î?? î?© would not be necessary . In the î?© î?? î?? . ) On the contrary , it would be senseless to apply this case , should the î?® î?¡ grant the î?© î?? î?? ? Apart from this , ac - these articles to third - party contract authorizations . Yet , cess to genetic resources does not overrule existing norms the only reference to confidentiality is found in article ï?? ï?? . on access to biological resources . In this case , even if an This article mandates confidentiality for all the information access permit is granted by the î?® î?¡ , would an additional submitted to the î?® î?¡ , unless biosafety concerns override permit under the î?? î?¶ î?? be required ? this norm . Confidentiality is one of the main protections Article ï?? ï?? governs the cases in which once the former companies seek . ( See paragraph ï?? ï?? of the î?? î?? î?? Expert conditions are met , ï?? ï?? % of the research budget and up to Panelâ??s First Report . ) Furthermore , the recently approved ï?? ï?? % of the royalties are given to the conservation area or Non - Disclosed Information Law establishes criminal private or indigenous owner . This terminology excludes sanctions for those who reveal confidential information . other relevant actors since the phrase â?? private owner â?쳌 is In spite of this , î?? î?¡ î?? î?? î?? î?? î?? î?? î?¡ â?? s multi - sector character can even more restrictive than , for example , â?? landlord â?쳌 or create confidentiality for companies . â?? tenants â?쳌 . Nevertheless , arenâ??t the latter supposed to be The rights granted to those who perform bioprospect - included in the î?© î?? î?? ? In this case , the phrase can be disre - ing are crucial . There is a tendency to grant to the term garded . Or , we can also interpret that when these monetary â?? public domain â?쳌 a scope difficult to sustain . Some think benefits have not been considered in the prior informed that when the State grants an access permit this only consent , the î?® î?¡ can demand their inclusion . This implies implies custody of the material for research purposes . that the î?® î?¡ could interfere in the negotiation process . But Which are the recipient - userâ??s rights ? In particular , are the parties could have excluded a monetary provision on there any transforming or protection rights such as the ones purpose , since , for example they could have stipulated embodied in the intellectual property rules ? Can the user different benefits to be shared . In this connection , it is not patent an improved material or an invention derived from clear whether these two stipulations have to be included a given genetic material ? Can a gene be isolated , char - in both the contracts ( î?© î?? î?? ) and the î?® î?¡ resolutions . This is acterized , and patented ? This is linked to the discussion aggravated by the fact that according to î?? î?? Article ï?? ï?? , and under the aegis of the î?? î?? î?¡ in relation to the Multilateral in conformity with rules issued by î?? î?¡ î?? î?? î?? î?? î?? î?? î?¡ , the î?® î?¡ has Access System for Plant Genetic Resources for Food and to dictate the deposit of up to ï?? ï?? % of the research budget Agriculture . According to it , delivered genetic resources , and ï?? ï?? % of the royalties . This detail seems to make this parts , and components cannot be protected under intellec - requirement mandatory in all cases . This generates some tual property . From a commercial point of view , this kind complications since there will not always be a research of restriction can be very important in the determination of ï?? ï?? ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : C ï쳌¯ ï쳌³ ï쳌´ ï쳌¡ R ï쳌© ï쳌£ ï쳌¡ whether a company will conduct bioprospecting or not . a tree ) . Large amounts of the bark were needed for small A reasonable solution would be to give free access yields of taxol and , initially , the demonstrated efficacy to the genetic material but without the possibility of pro - of the drug in the absence of being able to synthesize it tecting it , if there is no modification . In such a case , we or domesticate the tree , meant that the only source was would be in the presence of an invention and protection extraction from the native genetic resource . Fortunately , would be requested over a whole organism ( obviously synthesis of the chemical became possible , removing the including the genetic component associated with the rest need for extractive harvest . In the Costa Rican case , due of the organism ) . to the necessity of extracting more î?? î?? î?? î?© , attempts at do - In the same way , can microorganisms , genes , enzymes , mesticating Lonchocarpus felipei were made on a private and diagnostic agents obtained from genetic material by farm . If this experiment is successful , the interpretation of means of incorporating new genes obtained elsewhere the norms prompts at least three questions : be patented ? It must be remembered that some material ï?? . When does commercial usage begin ? In the î?? î?? î?? î?© transfer agreements from the Centers of the Consultative case , the decision to domesticate the tree on a farm Group onAgriculture Research include a clause preventing was made to avoid one of the common allegations patentability of transferred material and related informa - against bioprospecting : over - exploitation due to tion . This is also the case in the transfer agreements of the market pressures . Nevertheless , this action does î?? î?¡ î?¬ î?¬ î?? î?? î?? project ( Micro - Organism Sustainable Use and not imply the presence of a commercial phase . Access Regulation International Code of Conduct ) and The planting serves an initial research purpose other equivalent agreements . This point deserves a detailed with no certain economic benefits.According to the analysis linked to the next topic to be discussed . proposed regulation , would this imply a constant What are the implications of considering genetic economic use , thus requiring a public concession ? resources in the public domain if this means î?? î?© î?« s cannot It is my belief that this is not the case . Even in the be acquired , since applicants will be considered as hold - case in which genetic material is required for clini - ers ? Would a company agree to be granted custody only ? cal tests ( a provision that is often included in bio - The use restriction over the material should be clarified . prospecting contracts ) , it is only in the exploratory Normally the materials ( dry samples , etc . ) are not sent phase . Commercial use takes place only when it is as such . Instead bioprospectors send extracts , stock with in the presence of a final commercialized product . genetic resources , isolated genetic sequences , etc . The This would require a grant or concession following degree of restrictions over these materials is another the dispositions of the Law . important point . ï?? . Some regulators believe that the bioprospecting The framework agreements constitute an adequate permit and the permit for economic use should be mechanism to regulate access . Nevertheless , their real separate . This is derived from the oral explanation dimension is still to be assessed , since they are limited to from the members of î?? î?¡ î?? î?? î?? î?? î?? î?? î?¡ about the î?° î?¬ î?? basic research , excluding bioprospecting . Maybe in the National Cancer Instituteâ??s experience in Africa . In present state of affairs this makes sense , since universities this view , whenever a product is achieved , a new can conduct their teaching activities ( molecular taxonomy , negotiation process leading to an â?? economic use etc . ) without requiring individual permits for each project . approval â?쳌 should be started . This implies that the Would a similar approach be valid for the î?? î?? î?? io ? Apart research phase requires one permit and the com - from this , since according to the access procedure each mercialization another one . This interpretation sampling has to be approved by the respective conserva - artificially divides bioprospecting , since from the tion area , perhaps the best option would be to negotiate beginning it looks for economic gains . Obviously a framework agreement . This possibility is not contem - this point of view is incorrect , and the placement plated in the present draft . Also , a framework agreement in the market of derived products should be con - could be a possible way out for third - party access to ex sidered in the initial agreement where the sharing situ collections . 10 of benefits rules was agreed upon . The proposed î?? î?? î?© distinguishes four related situa - ï?? . Which is the concession procedure and how it is tions : basic research access ( including teaching , since differentiated from the access permit ? For example , the molecular taxonomy courses require access permits ) , in the case of î?? î?? î?? î?© , once its commercial potential is bioprospecting ( commercial exploration ) , and occasional identified , does the supplier have to obtain a conces - and constant economic use . The last two are differentiated sion to send the material ? It must be acknowledged from bioprospecting ( related to the idea of exploration ) . that inappropriate rules could lead interested parties For the occasional or constant economic use situations , to look for the materials elsewhere . In this case , the the user tries to access a genetic resource because of its communities and local entrepreneurs could lose the demonstrated commercial utility . For instance , taxol and possibility of profiting from their genetic materi - î?? î?? î?? î?© provide good examples . als , and scientists could lose the chance to conduct Taxol is the active ingredient with anticancer properties isolated from the bark of the Pacific yew ( Taxus brevifolia , certain scientific procedures in the country . Finally , ï?? ï?? ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ there is a thin line between constant and occasional is not regarded as an ally but as a suspect . As with any partner , bioprospectors should be governed by economic use . The initial phase of resource extrac - legal and contractual mechanisms , without omit - tion should guarantee the rational exploitation of ting good faith in the negotiations . The tendency the biological diversity . in some of the existing access regulations is to Finally , as in every process of change , new regulations control rather than to promote , an aspect that will bring uncertainties about the interpretation and application be dealt with properly later on . I should also point of the law , as well as for the duration of the process . This out the emotional aspect embodied in terms such as could produce delays due to the absence of experience and â?? National Patrimony â?쳌 and â?? Sovereignty â?쳌 , an aspect current capacities in the field . that transcends any juridical consideration . Based on my own experience , bioprospectors and other ac - â?¢ In general , there is uncertainty over the application cess applicants ( for basic research , teaching , etc . ) can have of new rules , the control character of the î?® î?¡ , the will the following concerns in relation to the legislation : to promote access or not , authorities â?? expertise on genetic research topics , the excessive bureaucratic â?¢ It is a subject matter where regulation is new . procedure , the high transaction costs , etc . Besides , the main focus of this regulation is to con - trol the flow of information , something complex Due to the difficulties explained above it is probable and full of difficulties . The first national regula - that basic research and teaching will be affected as , for tions were put forward in the Philippines in ï?? ï?? ï?? ï?? . example , in the molecular taxonomy technique , which is After this , several norms have been designed at the useful for national inventories . national or regional level achieving different levels The economic cost of applying for access is imprecise . of success in their implementation . However , with Article ï?? ï?? indicates that the î?® î?¡ will determine the amount only nine years since the first legislation , there are to be paid on a case - by - case basis . However , it is unlikely few examples related to achievements and failures that it will be an important amount ( probably less than that could be used as a guide . ï?? ï?? ï?? ï?? î?° î?¬ î?? ) . Other costs would depend on the hiring of a â?¢ Because of historical inequalities in access and lawyer ( not mandatory ) . benefit sharing , the regulatory authorities tend Finally , there are no specific conditions and costs for to be suspicious and try to impose strong control national and international bioprospectors . In practice , the mechanisms in order to avoid past injustices . existence of national bioprospectors as individuals or part - Suspicion and mistrust appear to be the main mo - ners with foreign entities would enable access , since there tivators behind this tendency . The bioprospector would be a responsible party in the country . Intellectual Property Rights The list below documents Costa Ricaâ??s comprehensive International Union for the Protection of New legislation related to î?? î?© î?« s . In addition , new laws have been Varieties of Plants ( î?° î?© î?¡ î?µ ) and its ï?? ï?? ï?? ï?? Act reform . enacted on integrated circuits , trademarks , and industrial In that area an important group composed of î?? î?? î?¡ s drawings , and there is an amended Copyrights Law . supported by local politicians has expressed their disagreement with the legislative draft on the impli - â?¢ The Patent , Drawings and Utility Models Law No . cations for farmers â?? seed reutilization . In the same ï?? ï?? ï?? ï?? was reformed by Law No . ï?? ï?? ï?? ï?? of ï?? ï?? January way , the scheme for community rights protection ï?? ï?? ï?? ï?? to make it compatible with î?® î?« î?? î?© î?¬ . Supposedly , should make some references to plant breeders â?? there are not exclusions for microorganisms , bio - rights in order to guarantee compatibility between logical processes , genes , and genetic sequences as the texts . However , the specificities of the proposal long as the patentability requirements are met.Yet , are still unknown since the participatory process there is no administrative or judicial practice in the that will determine those community rights has only field . recently begun . No concrete proposals have been â?¢ The Non - Disclosed Information Law No . ï?? ï?? ï?? ï?? was made to the î?® î?« î?? î?© î?¬ Council . passed on ï?? ï?? January ï?? ï?? ï?? ï?? . â?¢ The Plant Breeders â?? Rights Draft was published Articles ï?? ï?? and subsequent articles of î?? î?? are related to in The Gazette on ï?? ï?? August ï?? ï?? ï?? ï?? , but is yet to be the sui generis community intellectual rights . A participa - approved . tory process mandated in the law is working on the sui generis community î?? î?© î?« s . The consultations are expected â?¢ TheIntellectualPropertyRightsComplianceProcedure to be completed by ï?? ï?? ï?? ï?? . No . ï?? ï?? ï?? ï?? was passed on ï?? ï?? October ï?? ï?? ï?? ï?? . â?¢ A draft has been completed on plant breeders â?? In general , the Costa Rican System for the Protection of rights in accordance with the model law of the Traditional Knowledge is based on the following items : ï?? ï?? ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : C ï쳌¯ ï쳌³ ï쳌´ ï쳌¡ R ï쳌© ï쳌£ ï쳌¡ â?¢ A legal structure on access that guarantees prior Impact of IPRs on Biodiversity and informed consent and benefit sharing in relation Traditional Knowledge to traditional knowledge . The î?® î?¡ and , eventually , the î?? î?¡ î?? î?? î?? î?? î?? î?? î?¡ are granted with powers of control , During the process of drafting the î?? î?? and , as part of the authorization , and supervision ( î?? î?? Articles ï?? ï?? , ï?? ï?? , definition of regulations on access and benefit sharing , ï?? ï?? , and ï?? ï?? , among others ) . the topic of î?? î?© î?« s and their relationship with biodiversity â?¢ A combination of specific mechanisms for access - inevitably arose.Article ï?? ï?? of the î?? î?? states that these rights ing , contracting , and licensing processes and sui should support , and should not be opposed to , the objec - generis structures based on registries . tives of the agreement . Thus , the î?? î?? establishes that î?? î?© î?« s shall be congruent â?¢ Different forms of knowledge and innovation such with its objectives by virtue of the principle of integration as patents , commercial secrets , copyrights , plant ( Article ï?? ï?? ) . The î?? î?? excludes the following : î?? î?? î?? sequences breeders â?? rights , sui generis community intellectual from patent processes , plants and animals , unmodified rights , etc . ( Article ï?? ï?? ) protected through the use microorganisms , essential biological processes for plant of appropriate mechanisms ( î?? î?? Article ï?? ï?? ) . and animal production , the processes of nature or natural â?¢ Legislation focused on the protection of knowledge cycles , inventions essentially derived from the knowledge using a system of registration . This aspect is sup - of biological traditional practices or in the public domain , ported by the doctrine itself , which , in practical inventions that are produced monopolistically that may af - terms , has been implemented in India ( K ï쳌¡ ï쳌µ ï쳌³ ï쳌¨ ï쳌© ï쳌« fect the processes , and basic agricultural products used for ï?? ï?? ï?? ï?? , D ï쳌µ ï쳌´ ï쳌¦ ï쳌© ï쳌¥ ï쳌¬ ï쳌¤ ï?? ï?? ï?? ï?? ) , and in Venezuela . It was 11 food and health purposes ( Article ï?? ï?? ) . Authorities should also included in the draft of the Peruvian Regime consult the î?® î?¡ before granting protection of intellectual Proposal for the Protection of the Collective or industrial property - related innovations that involve Knowledge of the Indigenous Peoples and Access biodiversity elements . The submission of the certificate to Genetic Resources , among others . Therefore , it of origin and prior informed consent shall be required . A promotes the protection of the sui generis commu - well - grounded opposition by the î?® î?¡ shall prevent protec - nity intellectual property and inventions of the com - tion from being granted ( Article ï?? ï?? ) . It has been stated that munities that request such protection ( î?? î?? Article particular beneficiaries granted protection of intellectual ï?? ï?? ) . Nevertheless , these guidelines for registration or industrial property rights regarding biodiversity must have been criticized due to some adverse effects cede to the State a legal obligatory license . In the event of a they may produce ( D ï쳌¯ ï쳌· ï쳌® ï쳌¥ ï쳌³ and L ï쳌¡ ï쳌© ï쳌² ï쳌¤ ï?? ï?? ï?? ï?? , R ï쳌µ ï쳌© ï쳌º justified emergency , this license will allow the use of such ï?? ï?? ï?? ï?? ) . Some of the adverse judgments expressed rights for the benefit of the community . This provision is are : the need to define access to information , the aimed at solving an emergency , without involving com - control required thereto , the possibility that com - pensation or royalty payment ( Article ï?? ï?? ) . Some have af - munities not involved in the access will grant prior firmed that there are contradictions in certain clauses with informed consent , registering knowledge in the respect to î?® î?« î?? î?© î?¬ ( C ï쳌¡ ï쳌² ï쳌¶ ï쳌¡ ï쳌¬ ï쳌¨ ï쳌¯ ï?? ï?? ï?? ï?? ) and therefore , based name of third parties , etc . on the Costa Rican structures , with the Constitution itself ; To define the scope , nature and requirements of these pursuant to our judicial system , Treaties have a superior rights , a participatory process should begin to consult in - value over ordinary law and shall not be disregarded by digenous communities and peasants ( î?? î?? Article ï?? ï?? ) on the the law . Furthermore , it is important to emphasize certain subject . Likewise , the process will determine the form in questions that are fundamental because , to some extent , which the intellectual community right will be used , who they were the express or implicit cause of these regula - will be vested with powers of representation , and who the tions ( C ï쳌¡ ï쳌¢ ï쳌² ï쳌¥ ï쳌² ï쳌¡ M ï쳌¥ ï쳌¤ ï쳌¡ ï쳌§ ï쳌¬ ï쳌© ï쳌¡ ï?? ï?? ï?? ï?? , C ï쳌¡ ï쳌¢ ï쳌² ï쳌¥ ï쳌² ï쳌¡ M ï쳌¥ ï쳌¤ ï쳌¡ ï쳌§ ï쳌¬ ï쳌© ï쳌¡ corresponding beneficiaries are ( î?? î?? Article ï?? ï?? ) . Based on and A ï쳌¬ ï쳌¡ ï쳌² ï쳌£ ï?³ ï쳌® ï?? ï?? ï?? ï?? ) : the aforementioned , and concerning the assignment of â?¢ Are traditional î?? î?© î?« systems insufficient in relation rights and responsibilities , either collective or private , the to the protection of knowledge , innovations , and following items must be explained : practices , such as it is affirmed by the doctrine ? â?¢ The object of protection ; Or , on the contrary , could they be used in order to â?¢ The protection process ; protect important sectors involved , for example , in â?¢ The rights granted and the party responsible for using trademarks and denominations of origin ? compliance thereof ; and â?¢ What possibilities exist for î?? î?© î?« to add value to â?¢ Monitoring systems . biodiversity and the associated knowledge , in an indirect manner , by protecting a market of protected Definitely , the success of the proposed scheme will products ? If there are possibilities , how could such depend to a great extent on the existence of the bylaw mechanisms be useful to claim such value ( L ï쳌¥ ï쳌³ ï쳌³ ï쳌¥ ï쳌² and the outcome of the participatory process called to examine it . ï?? ï?? ï?? ï?? ) ? ï?? ï?? ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ acteristics ( as has been the argument with respect â?¢ Is it possible and viable to establish the so - called to the neem , turmeric , and ayahuasca plants ) . Can Certificate of Origin ( T ï쳌¯ ï쳌¢ ï쳌© ï쳌® ï?? ï?? ï?? ï?? ) so that it is a î?? î?© î?« s restrict the exportation of traditional products requirement to present a record or document on ( beans in Mexico , for example ) , claiming the ex - the legality of the access and benefit sharing ? This istence of plant breeders â?? rights or patents granted requirement is contemplated in the Peruvian regu - in the importation market to third parties on the lation on Plant Breeders â?? Rights , in Decision ï?? ï?? ï?? characteristics of these products ? of the Andean Community Common Regime on Access to Genetic Resources , in Decision ï?? ï?? ï?? of â?¢ Up to what point do î?? î?© î?« s have a direct impact on the same regional entity on a Regime of Industrial the environment and on the conservation and sus - Property , and in the î?? î?? of Costa Rica ( Article tainable use of genetic resources and traditional ï?? ï?? ) , among others . This topic has been discussed knowledge ? For example , up to what point do they in the World Trade Organization , mainly in the facilitate or hinder the transfer of safe environmen - Council of î?® î?« î?? î?© î?¬ and the Committee for Trade tal technologies or create undesirable effects such and Environment , where different countries and as genetic erosion ? To what extent do they increase the use of synthesis chemicals ( especially given the groups have presented proposals to include this sale of seeds that are transgenic and resistant to requirement in the revised text of these proposals . herbicides ) or orient research and development to Furthermore , other forums like the Patent Treaty areas that are not desired and create a homogenous of î?¶ î?? î?© î?¡ and its Working Group on Biotechnology , agriculture that is not adapted to local needs ? have touched upon the topic . Different objections have been presented from incompatibility with the â?¢ The sui generis system for plant variety can be fixed patent requirements of the î?¶ î?® î?¡ ( Article ï?? ï?? used , which was foreseen in î?® î?« î?? î?© î?¬ Article ï?? ï?? . ï?? b of î?® î?« î?? î?© î?¬ ) to practical criticisms ( difficulties with that protects traditional knowledge and stipulates respect to plant varieties originating in different benefit sharing , despite the fact that , in the î?® î?« î?? î?© î?¬ countries , or from crosses and retro - crosses ; the fact framework , this statement takes on a singular mean - that a product or patent process does not necessar - ing ( L ï쳌¥ ï쳌³ ï쳌« ï쳌© ï쳌¥ ï쳌® and F ï쳌¬ ï쳌© ï쳌´ ï쳌® ï쳌¥ ï쳌² ï?? ï?? ï?? ï?? ) . ily reach the market ; the additional workload for â?¢ Does the stipulation of î?? î?© î?« s in access contracts guar - the Intellectual Property Offices ; and the lack of anteeing larger returns to the countries of origin or patents of multiple products derived from tropical local contractors , including communities , actually biota , etc . ) . entail greater returns for the companies involved , given the lack of competition and copies ? Are they â?¢ In what way do î?? î?© î?« s impact biodiversity , for a marketing mechanism that allows greater royalty example , through restrictions on the exchange payments for the company and therefore contrib - of seeds through patents , plant breeders â?? rights , utes even more to benefit sharing ? contracts or technology to control the expression of genes ? Up to what point can impediments be â?¢ Finally , has the International Undertaking had any produced in traditional practices given patents and influence on national access laws ? The î?? î?? does not other awarded rights on inventions that claim the mention the possibility of including a clause on use of genetic resources even when , from a legal genetic and biochemical resources used for food point of view , these rights , many of which have and agriculture , subject to easy access as prescribed been revoked in the United States or Europe , never by the recently approved International Treaty on should have been granted because the processes Plant Genetic Resources for Food and Agriculture werenâ??t new or because they lacked invention char - ( that substitutes for the Undertaking ) . Lessons Learned and Recommendations The Costa Rican experience has provided some of the offering such protection , plays an important role in ben - most relevant examples in terms of obstacles as well as efit sharing and compensation for the commercial use of achievements with respect to the regulation on access to the knowledge and resources . In the first view , registries genetic resources , intellectual property , and traditional would be enough to conserve and safeguard the informa - knowledge . We must indicate that there are two views , to tion , publications , and other mechanisms and to avoid its some extent opposed , with respect to the underlying idea inappropriate use ( destruction of the novelty requirement behind regulation of access ( C ï쳌¡ ï쳌© ï쳌¬ ï쳌¬ ï쳌¡ ï쳌µ ï쳌¸ et al . ï?? ï?? ï?? ï?? ) . On the of the patents , nondisclosed information laws , etc . ) . The one hand , protection of traditional knowledge and access other view , although recognizing this reality , seeks to cre - to genetic resources is seen as a conservation strategy and ate or provide mechanisms for the distribution of benefits . as a way to avoid the theft and inappropriate use of these The following sections summarize the main lessons and resources , especially through the system of ï쳌© ï쳌° ï쳌² s . On the recommendations that are provided by the Costa Rican other hand , access is seen as a mechanism that , besides experience . ï?? ï?? ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : C ï쳌¯ ï쳌³ ï쳌´ ï쳌¡ R ï쳌© ï쳌£ ï쳌¡ The Myth of Biodiversity Prospecting Linking Access with National Biodiversity Strategies for Conservation and Programs and the Expected Values in Sustainable Use Return Unfortunately , the evolution of legal regulations on access For years , prospecting was associated with the exploration to genetic resources has been separate from the definition for ore and hydrocarbons . In the early nineties , Thomas of national policies on conservation and sustainable use of Eisner is credited with using the term , or at least popular - biological diversity . As a result , the contribution of mon - izing it , for the exploration for biodiversity . Both types etary as well as nonmonetary benefits barely touches upon of exploration present different levels of risk ; therefore , the conservation process . When nations , through mecha - distribution of benefits will depend on the understanding nisms that are highly participatory , establish public poli - of how these activities operate . The bioprospector , despite cies on this matter , concrete negotiations to allow access different studies that show the existing potential benefits , could reach wider objectives . Ultimately , these National is unaware of what exactly he will find in the rich tropi - Strategies must serve the development and strengthening cal jungles . The wealth in terms of biodiversity does not of the national and institutional capacities that give the necessarily translate into marketable products such as new resources added value . medicines and seeds . In this sense , those who believed that bioprospecting Definition of Property Rights would become a â?? green mine of gold â?쳌 have had to modify or moderate their observations . In Costa Rica the income It is urgent that property rights on genetic and biochemi - contributed by the biodiversity prospecting program cal resources be defined . The î?? î?? î?? only mentions the sov - reaches several million î?° î?¬ î?? overall and makes important ereignty of the State over them without considering the existing property rights . With this in mind , the clear dif - contributions to technology , capacity training , equipment , ferentiation among the concepts of property , sovereignty , the National System of Conservation Areas , and , most and national patrimony is necessary for legal certainty . importantly , to the creation of national capacities and ne - The uncertainty over who owns the genetic resources gotiation capacities . Although this last aspect stands out leads to difficulties in the process of obtaining the î?© î?? î?? as the most important in relation to acquired benefits , it is and in determining who should participate in the access important to point out that ecological tourism contributed negotiations . In turn , this creates difficulties in reaching ï?? ï?? ï?? ï?? million î?° î?¬ î?? in just one year , making bioprospectingâ??s agreements on access that are appropriate given the exist - return seem relatively small with respect to the amount ing doubts and companies â?? requirements to have adequate of money obtained . From this perspective , biodiversity guarantees on the legality of the procedures and to avoid prospecting is a component of a much larger strategy of public and judicial problems . conservation and sustainable use of biodiversity rather than a solution for the immediate needs of conservation . Access and Technological Change Without Access There is no Benefit According to R ï쳌¥ ï쳌© ï쳌¤ ( ï?? ï?? ï?? ï?? ) we can affirm that technology plays a relevant and contradictory role in the process of Sharing access . On one hand , new screening techniques and re - Our historical background on this matter has shown that combinant biotechnology have opened doors to the use of there was a perceived need for stricter controls on access biodiversity elements never known before and have greatly to avoid so - called biopiracy . Some regulations to date have increased the value of these resources and knowledge . But concentrated more on controlling than on promoting ac - on the other hand , the reduction of operational costs and the cess . Such a regulatory focus can inadvertently result in ability facilities to work with fewer samples have reduced the ignoring of the objectives of the î?? î?? î?? and individual the concrete value of each resource and have facilitated national laws , despite the good intentions of those who pro - the illegal trade of resources . posed the regulations . Such regulations are creating high It is essential to follow the changes in technology . transaction costs and complicated bureaucratic procedures Eventually , technological advances such as combinatory leading to an absence of access applications without which chemistry could result in a reduction of interest in biodi - it is not possible to speak about benefit sharing . If the idea versity , access , and the use of traditional knowledge . It is persists that access represents a form of colonialism , in - important to be aware of these transformations . stead of a mechanism to generate joint initiatives adequate for all participants , the possibility of generating reasonable Impact of Access on National Basic experiences will be limited . Besides the necessary legal Research guarantees , it is important to foresee regimes that are suf - ficiently flexible and transparent . Furthermore , there must The regulations on access are based on the idea of conserv - be a balance between confidentiality and transparency and ing biological diversity , its sustainable use , and the fair the access of third parties to the results of negotiations . distribution of its benefits . An indispensable component ï?? ï?? ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ to reach these objectives lies in basic research , especially Participatory Processes when there is no essential information on ecosystems and species . Research conducted by universities and research Participatory processes are important in an area of centers represents in itself an element that contributes great national importance such as biological diversity . to this process . The rules on access could interfere with Notwithstanding this fact , participation requires enough this research , for example , by controlling nonscientific information to avoid an â?? observer only â?쳌 role for certain activities in order to regulate the resulting commercial stakeholders . This need is increased by the complex na - benefits and thereby affecting the attainment of the î?? î?? î?? â?? s ture of the topics . At the same time , greater participation objectives . This negative impact must be avoided through involves transactions , internal negotiations , and compro - adequate procedures that favor basic research . mises that could result in weaker legislation . Conclusion The Costa Rican experience has shown interesting details ence on access and benefit sharing presented at the level that are worthy of mention , although it does not necessarily of contracts and collaboration agreements with the public , constitute an example to follow in other countries . Peculiar private , national , and international sectors , the formula - circumstances of the national reality ( read about these par - tion of a Law on Biodiversity that seeks answers to the ticular situations in M ï쳌¡ ï쳌´ ï쳌¥ ï쳌¯ ï?? ï?? ï?? ï?? ) , the size of the country , challenges proposed by the î?? î?? î?? , and the regulation of the a central government , and its political , educational , and main principles of the sui generis model are elements that social situation have led it to establish its own terms . It provide valuable information for future debate on access is the example of a nation that decided to choose a path laws and policies . This is , possibly , the most valuable instead of arguing about existing problems that impeded aspect of the Costa Rican experience . advancement . From this point of view , the practical experi - References C ï쳌¡ ï쳌¢ ï쳌² ï쳌¥ ï쳌² ï쳌¡ M ï쳌¥ ï쳌¤ ï쳌¡ ï쳌§ ï쳌¬ ï쳌© ï쳌¡ , J . ï?? ï?? ï?? ï?? . Premisas , principios y con - knowledge : The Indian experience . Unpublished manuscript . tenidos de una ley marco sobre la diversidad biológica . L ï쳌¥ ï쳌³ ï쳌« ï쳌© ï쳌¥ ï쳌® , D . and M . F ï쳌¬ ï쳌© ï쳌´ ï쳌® ï쳌¥ ï쳌² . ï?? ï?? ï?? ï?? . Intellectual property Revista Ivstitia , San José , Costa Rica . rights for plants : Options for a sui generis system . Issues C ï쳌¡ ï쳌¢ ï쳌² ï쳌¥ ï쳌² ï쳌¡ M ï쳌¥ ï쳌¤ ï쳌¡ ï쳌§ ï쳌¬ ï쳌© ï쳌¡ , J . ï?? ï?? ï?? ï?? . Soberanía , derechos de in Plant Genetic Resources , No ï?? . propiedad intelectual y biodiversidad , Revista Mensual L ï쳌¥ ï쳌³ ï쳌³ ï쳌¥ ï쳌² , W . ï?? ï?? ï?? ï?? . Propiedad intelectual y biodiversidad . p . de Gestión Ambiental . Universidad Carlos III , Madrid , ï?? ï?? â?? ï?? ï?? in A.G . R ï쳌¯ ï쳌¤ ï쳌² ï?­ ï쳌§ ï쳌µ ï쳌¥ ï쳌º ( ed . ) La conservación y Spain . el uso sostenible de la biodiversidad para el desarrollo C ï쳌¡ ï쳌¢ ï쳌² ï쳌¥ ï쳌² ï쳌¡ M ï쳌¥ ï쳌¤ ï쳌¡ ï쳌§ ï쳌¬ ï쳌© ï쳌¡ , J . and E . A ï쳌¬ ï쳌¡ ï쳌² ï쳌£ ï?³ ï쳌® . ï?? ï?? ï?? ï?? . Acceso a los sostenible . î?¬ î?? î?? î?? î?? î?? î?¬ , San José , Costa Rica . recursos genéticos y el papel de los derechos de pro - M ï쳌¡ ï쳌´ ï쳌¥ ï쳌¯ , N . ï?? ï?? ï?? ï?? . Wild biodiversity : The last frontier ? The piedad intelectual . Investigación Agrícola y Propiedad case of Costa Rica . p . ï?? ï?? â?? ï?? ï?? in C . B ï쳌¯ ï쳌® ï쳌´ ï쳌¥ - F ï쳌² ï쳌© ï쳌¥ ï쳌¤ ï쳌¨ ï쳌¥ ï쳌© ï쳌­ ï쳌¡ ï쳌® ï쳌¤ Intelectual , î?© î?« î?¡ î?? î?? î?® î?« î?¡ î?© î?? î?? î?¡ î?¬ , Brasilia , Brazil . and K . S ï쳌¨ ï쳌¥ ï쳌² ï쳌© ï쳌¤ ï쳌¡ ï쳌® ( eds . ) The place of agricultural re - C ï쳌¡ ï쳌© ï쳌¬ ï쳌¬ ï쳌¡ ï쳌µ ï쳌¸ , J . , M . R ï쳌µ ï쳌© ï쳌º , and B . T ï쳌¯ ï쳌¢ ï쳌© ï쳌® . ï?? ï?? ï?? ï?? . El Régimen search . î?? î?¬ î?? î?? î?« , The Hague , Netherlands . Andino de Acceso a los Recursos Genéticos : Lecciones y R ï쳌¥ ï쳌© ï쳌¤ , W . ï?? ï?? ï?? ï?? . Technological change and regulation of ac - experiencias . ï쳌³ ï쳌° ï쳌¤ ï쳌¡ , Lima , Perú and ï쳌· ï쳌² ï쳌© , Washington ï쳌¤ ï쳌£ cess to genetic resources . p . ï?? ï?? â?? ï?? ï?? in J . M ï쳌µ ï쳌§ ï쳌¡ ï쳌¢ ï쳌¥ , C.V . ï쳌µ ï쳌³ ï쳌¡ . B ï쳌¡ ï쳌² ï쳌¢ ï쳌¥ ï쳌² , H . G ï쳌µ ï쳌¤ ï쳌² ï쳌µ ï쳌® , L . G ï쳌¬ ï쳌¯ ï쳌· ï쳌« ï쳌¡ , and A . L ï쳌¡ V ï쳌© ï?± ï쳌¡ ( eds . ) C ï쳌¡ ï쳌² ï쳌¶ ï쳌¡ ï쳌¬ ï쳌¨ ï쳌¯ , N . ï?? ï?? ï?? ï?? . Ley de Biodiversidad de Costa Rica : Access to genetic resources : Strategies for sharing ben - Compatibilidad entre el Convenio de Diversidad efits . ACTS Press , î?¶ î?« î?? , î?? î?? î?? - î?? î?° î?? î?? , Nairobi , Kenya . Biológica ( î?? î?? î?? ) y el î?® î?« î?? î?© î?¬ . Document prepared for the R ï쳌¥ ï쳌© ï쳌¤ , W.V . , S.A . L ï쳌¡ ï쳌© ï쳌² ï쳌¤ , C.A . M ï쳌¥ ï쳌¹ ï쳌¥ ï쳌² , R . G ï?¡ ï쳌­ ï쳌¥ ï쳌º , A . î?° î?© î?¡ î?µ - î?¡ î?? î?© î?? National Seminar on Vegetal Obtentions and S ï쳌© ï쳌´ ï쳌´ ï쳌¥ ï쳌® ï쳌¦ ï쳌¥ ï쳌¬ ï쳌¤ , D.H . J ï쳌¡ ï쳌® ï쳌º ï쳌¥ ï쳌® , M.A . G ï쳌¯ ï쳌¬ ï쳌¬ ï쳌© ï쳌® , and C . J ï쳌µ ï쳌­ ï쳌¡ Bioqdiversity Protection , San José , Costa Rica . ( eds . ) ï?? ï?? ï?? ï?? . Biodiversity prospecting . World Resources D ï쳌¯ ï쳌· ï쳌® ï쳌¥ ï쳌³ , D . and S . L ï쳌¡ ï쳌© ï쳌² ï쳌¤ . ï?? ï?? ï?? ï?? . Registries of local and indig - Institute , Washington DC USA . enous knowledge relating to biodiversity . Prepared for the R ï쳌µ ï쳌© ï쳌º , M . ï?? ï?? ï?? ï?? . Protecting indigenous peoples knowledge : A î?° î?? î?? î?® î?? î?? Biotrade Initiative . policy and legislative perspective from Perú , Sociedad D ï쳌µ ï쳌´ ï쳌¦ ï쳌© ï쳌¥ ï쳌¬ ï쳌¤ , G . ï?? ï?? ï?? ï?? . Intellectual property rights , trade and Peruana de Derecho Ambiental , Policy and Environmetal biodiversity . Earthscan , London , UK . Law Series , No ï?? , Lima , Perú . G ï?¡ ï쳌­ ï쳌¥ ï쳌º , R . and A . S ï쳌© ï쳌´ ï쳌´ ï쳌¥ ï쳌® ï쳌¦ ï쳌¥ ï쳌¬ ï쳌¤ . ï?? ï?? ï?? ï?? . Biodiversity prospect - T ï쳌¯ ï쳌¢ ï쳌© ï쳌® , B . ï?? ï?? ï?? ï?? . Certificates of origin : A role of IPR regimes ing by î?? î?? î?? io . p . ï?? ï?? â?? ï?? ï?? in W.V . R ï쳌¥ ï쳌© ï쳌¤ , S.A . L ï쳌¡ ï쳌© ï쳌² ï쳌¤ , C.A . in securing prior informed consent . p . ï?? ï?? ï?? â?? ï?? ï?? ï?? in J . M ï쳌¥ ï쳌¹ ï쳌¥ ï쳌² , R . G ï?¡ ï쳌­ ï쳌¥ ï쳌º , A . S ï쳌© ï쳌´ ï쳌´ ï쳌¥ ï쳌® ï쳌¦ ï쳌¥ ï쳌¬ ï쳌¤ , D.H . J ï쳌¡ ï쳌® ï쳌º ï쳌¥ ï쳌® , M.A . M ï쳌µ ï쳌§ ï쳌¡ ï쳌¢ ï쳌¥ , C.V . B ï쳌¡ ï쳌² ï쳌¢ ï쳌¥ ï쳌² , H . G ï쳌µ ï쳌¤ ï쳌² ï쳌µ ï쳌® , L . G ï쳌¬ ï쳌¯ ï쳌· ï쳌« ï쳌¡ , and G ï쳌¯ ï쳌¬ ï쳌¬ ï쳌© ï쳌® , and C . J ï쳌µ ï쳌­ ï쳌¡ ( eds . ) Biodiversity prospecting . A . L ï쳌¡ V ï쳌© ï?± ï쳌¡ ( eds . ) Access to genetic resources : Strategies World Resources Institute , Washington DC USA . for benefit sharing . î?? î?? î?® î?¬ Press , î?¶ î?« î?? , î?? î?? î?? - î?? î?° î?? î?? , Nairobi , K ï쳌¡ ï쳌µ ï쳌³ ï쳌¨ ï쳌© ï쳌« , A . ï?? ï?? ï?? ï?? . Protection of biodiversity and traditional Kenya . ï?? ï?? ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : C ï쳌¯ ï쳌³ ï쳌´ ï쳌¡ R ï쳌© ï쳌£ ï쳌¡ Endnotes 1 The î?¬ î?? î?? î?? î?? is a department of the Ministry of Energy and has submitted its internal rules , but according to the î?? î?¡ î?? î?? î?? î?? î?? î?? î?¡ Environment . these are too general . Consequently , the Commissionâ??s rules will 2 still be applicable for specific matters not contemplated in the The Strategy proposes thirteen strategic elements . The last one is general norms . Without wanting to go in deep in the discussion , I called â?? Establishment of the mechanisms needed to facilitate ac - have to say that the meaning of â?? not - for - profit â?쳌 is not always clear . cess to genetic resources of biodiversity and the fair and equitable The î?? î?¡ î?? î?? î?? î?? î?? î?? î?¡ has not provided any guideline to the universities distribution of the benefits derived from them . â?쳌 It establishes the on the content and conditions of these internal procedures . technical , normative , and organizational frame to guarantee the just 8 and equitable access to the elements of biodiversity , along with a These articles have as background the cooperation agreement set of strategies and concrete actions . between î?? î?? î?? î?? î?? and î?? î?? î?? io , which established this percentage of 3 the budget and royalties to the transferred to the î?? î?? î?? î?? î?? . However , The Unconstitutionality Action was presented against other dispo - the agreement mentions that when the budget cannot be used as a sitions of the Law related to the managing and specific destiny of basis for calculations , other formula for the distribution of benefits public funds , as well as to the juridical status of the î?¬ î?? î?? î?? î?? . These should be designed . issues will not be commented upon since they deal with matters foreign to this report . Nevertheless , it must be indicated that the 9 The Access Norms contemplate a series of restrictions ( Article action presented against the National System has contributed to the ï?? ï?? ) , some of which are found in comparative law ( e.g . , danger of lack of implementation of the Legislation in its entirety . extinction , endemism , fragility or ecosystem vulnerability , access 4 Article ï?? ( Area of Application ) of the î?? î?? î?© establishes that it will for military ends , etc ) . Other restrictions are not so clear like apply to in situ and ex situ genetic and biochemical elements of â?? denaturalization of the resources â?쳌 . It is not clear which additional wild or domesticated biodiversity that are under the sovereignty of limitations can be used by the î?® î?¡ for nonendorsement of a contract . the State , whether in public or private property . 10 The fact that this is the thesis of the î?? î?? î?© proponents is even more 5 See the Law of Phytosanitary Protection and diverse decrees ap - evident in Article ï?? . ï?? , â?? Additional requirements for requesting an plicable to the exportation of materials . occasional or constant economic use permit â?쳌 . It establishes the ob - 6 ligation to pay to the conservation area , landowner , or indigenous Information provided by the Bioprospecting Program of î?? î?? î?? io . community where access took place up to ï?? ï?? % of the royalties 7 An article of the î?? î?? establishes that the public universities have one obtained by the interested party . year to design internal procedures and internal controls only ap - 11 One thesis holds that reforms to the Patent Law of ï?? ï?? ï?? ï?? tacitly plicable to academic and research activities , when this implies not - derogated the exclusions of the Law of Biodiversity since they for - profit access to biodiversity . The universities that fail to do this were promulgated later on ; it excludes some , but not all , of the in the elapsed time will have to abide by the ordinary procedure embodied in the law . Up to now only the University of Costa Rica aspects provided in î?? î?? Article ï?? ï?? from the patent process . ï?? ï?? ï?? ï?? ï?? ï?? 6 Mexico : Between Legality and Legitimacy Jorge Larson - Guerra , Christian López - Silva , Francisco Chapela , José Carlos Fernández - Ugalde and Jorge Soberón 1 Should access to genetic resources be regulated differently ies and plant health . Relevant regulation designating 2 from other biological resources ? Yes , because the objective certain species as strategic was passed in the ï?? ï?? ï?? ï?? Rural of appropriation is different . The essence of the difference Sustainable Development Act ( ï쳌² ï쳌³ ï쳌¤ ï쳌¡ ) . However , genetic is that once the information in the genetic resource has been resources lack a specific and comprehensive regulatory accessed , once the key value is outside the hands of the framework . Currently , there are two formal legal initiatives owner of the land or the genetic resource ( be it a farmer , in Congress that purport to fill this gap . Their content will an ethnic group , or a country ) , there is no need for further be addressed later , but it is fair to say that that they have access . The biological material or individual accessed has not been widely discussed and they are not a priority in been used or transformed , and the value is beyond the the legislative agenda . control of the provider . On the other hand , to hunt deer , The process of extracting genetic resources from spe - cut trees , or fish tuna implies the harvesting of individuals cies with the aim of developing an industrial application , again and again . In contrast , the main source of value from either within or outside the jurisdiction in which access genetic materials is the â?? information â?쳌 contained in the took place , must be regulated through specific provisions genetic resource ; once it has been accessed there is rarely for legal use within access and benefit - sharing agree - a need for additional extractions , and the information can ments and in compliance with Convention on Biological be shared with others without necessarily requiring more Diversity ( ï쳌£ ï쳌¢ ï쳌¤ ) obligations . Access and benefit sharing genetic material . In addition , the degree of redundancy ( ï쳌¡ ï쳌¢ ï쳌³ ) requires regulating a complex set of actions and inter - found in genetic information across taxa implies that us - ests whose legal , institutional , and commercial framework ers may need to prospect only a small subset of Earthâ??s has been well described by ï쳌´ ï쳌¥ ï쳌® K ï쳌¡ ï쳌´ ï쳌¥ and L ï쳌¡ ï쳌© ï쳌² ï쳌¤ ( ï?? ï?? ï?? ï?? ) . species before finding most of the information they need . Once access to a genetic resource has occurred the steps This does not imply that genetic resources are valuable between appropriation and industrial innovation may be only because of the information they contain ; in fact , we complicated and difficult to follow . This is the basic reason think they are much more than that . But we cannot hide why there should be legally binding agreements that should the fact that much of the debates related to bioprospect - clearly state the rules of the game and explicitly include ing and biopiracy implicitly view genetic resources as present and future benefits for all those involved . ï?? valuable information . In Mexico , the conventional use of Adding to this complexity is the use of traditional biological resources is now regulated more precisely and knowledge ( ï쳌´ ï쳌« ) in the development of products that may with sustainability criteria by the Ecological Equilibrium be patented . If the contribution of the genetic resource and Environmental Protection General Act ( ï쳌¥ ï쳌¥ ï쳌¥ ï쳌° ï쳌§ ï쳌¡ ) , the itself to a biotechnological invention is not yet fully rec - Wildlife General Act ( ï쳌· ï쳌§ ï쳌¡ , M ï쳌¥ ï쳌¸ ï쳌© ï쳌£ ï쳌¡ ï쳌® C ï쳌¯ ï쳌® ï쳌§ ï쳌² ï쳌¥ ï쳌³ ï쳌³ ï?? ï?? ï?? ï?? ) ognized , then a respectful development of new products and the Sustainable Forestry Development General Act involving ï쳌´ ï쳌« seems even more difficult to implement . The ( ï쳌³ ï쳌¦ ï쳌¤ ï쳌§ ï쳌¡ ) and within the complex institutions of fisher - so - called nontangible component of the genetic resource ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ may be even more important culturally and ethically to of different sectors . Surprisingly , while our country played local communities than the genetic resource itself . Thus , an important role since the negotiations started ten years ï쳌¡ ï쳌¢ ï쳌³ in cases where ï쳌´ ï쳌« is a component of the agreement ago it has not signed the treaty yet . tends to be much more complicated . Inequity between the Most genetic resources have not been collected yet , recognition given to collective and diffuse knowledge and as is the case for most ï쳌¦ ï쳌¡ ï쳌¯ - related crops , and this is a that given to individual invention property rights ( H ï쳌¥ ï쳌² ï쳌³ ï쳌£ ï쳌¨ relevant difference in terms of the negotiating position of and L ï쳌¡ ï쳌² ï쳌³ ï쳌¯ ï쳌® ï?? ï?? ï?? ï?? ) is often an additional complication . megadiverse countries with respect to ï쳌¡ ï쳌¢ ï쳌³ . If we harvest Therefore , this added complexity stresses the importance a biological resource , the territory or land ownership can to analyze ï쳌¡ ï쳌¢ ï쳌³ and ï쳌´ ï쳌« issues in a separate way but always be a logical criterion for property rights , but when genetic keeping in mind its close interdependence ( F ï쳌¥ ï쳌² ï쳌® ï?¡ ï쳌® ï쳌¤ ï쳌¥ ï쳌º resources are separated from their territory , land property et al . ï?? ï?? ï?? ï?? ) . as a criterion is clearly limited . If someone sells a permit These are some of the fundamental reasons why ac - for deer hunting , he does not necessarily invade the rights cess to genetic resources should be differentiated from of others . But if he offers access to the genes of a plant the simple use of biological resources . This difference is living on his land and on his neighbors â?? land , he faces the clearly recognized in the ï쳌£ ï쳌¢ ï쳌¤ objectives : â?? the conservation possibility of incurring moral or patrimonial damage to of biological diversity , the sustainable use of its compo - third parties . This fact clearly justifies the need of State 4 6 nents , and the fair and equitable sharing of the benefits involvement in these processes . By analogy , Mexicoâ??s arising out of the utilization of genetic resources , including Constitution , like many other legal frameworks around the by appropriate access to genetic resources and by appropri - world , takes an approach that justifies State intervention ate transfer of relevant technologies , taking into account when dealing with the issue of water sources emanating all rights over those resources and to technologies , and by from a property the use of which impacts the availability appropriate funding â?쳌 . of water downstream . It is very important to have a clear Despite the apparent clarity and simplicity of the stated solution to this issue of wider interest in the case of genetic objective , institutions have been slow in responding to this resources and to have in mind that it involves complex in - new reality . The potential economic value of a genetic stitutional designs and the need to face difficult and diverse resource depends substantially on further investments in social and cultural realities . Developing countries tend to research and development . Of course the genetic resource have weak law enforcement in general , particularly within itself must be paid for , but this accounts only for part of natural resource use and conservation . Thus , it is naïve to the value that a product or production process can gen - think that the solution is only legal . The development of erate . Translating the conceptual notion of evolutionary policies regarding genetic resources has to include careful value into a concrete rule to estimate a fair share of the consideration of diffuse property rights , common goods , benefits for the genetic resource is not easy ( S ï쳌· ï쳌¡ ï쳌® ï쳌³ ï쳌¯ ï쳌® and collective rights and innovations . ï?? ï?? ï?? ï?? ) . Developing a drug and obtaining a legitimate patent Prior to the ï쳌£ ï쳌¢ ï쳌¤ , genetic resources flowed freely among requires time and resources . As a result , ensuring that a countries , but also biotechnology inventions such as genes share of the benefits is received by the provider of genetic were rarely protected by patents . After the ï쳌£ ï쳌¢ ï쳌¤ came into resources and / or associated traditional knowledge requires force , there has been a slow adjustment to the new regime . complex institutional designs . Thus , legitimate and legal Since the appropriation processes for different natural re - bioprospecting projects usually have high transaction sources are different , the rights and obligations related to costs . The cases described in this chapter will reveal some them are also different ( Figure ï?? ) . of the many forms that these costs can take . Since legal change is not usually retroactive , we have to Seeds , vegetative parts , and other reproductive ma - face the situation of materials collected pre - ï쳌£ ï쳌¢ ï쳌¤ and depos - terials including larvae or sperm , have been collected ited in ex situ collections . Whether public or private , their systematically and exchanged under the aegis of the legal status has not been fully clarified . This is also an area Food and Agriculture Organization ( ï쳌¦ ï쳌¡ ï쳌¯ ) as common where the ï쳌© ï쳌´ ï쳌° ï쳌§ ï쳌² ï쳌¦ ï쳌¡ will have important consequences . On heritage resources or , in other words , as biodiversity in the other hand , there has been further collecting post - ï쳌£ ï쳌¢ ï쳌¤ trust ( F ï쳌µ ï쳌£ ï쳌£ ï쳌© ï쳌¬ ï쳌¬ ï쳌¯ et al . ï?? ï?? ï?? ï?? ) . Until a decade ago these without prior informed consent ( ï쳌° ï쳌© ï쳌£ ) and benefit - sharing resources were rarely subject to patent claims , but with agreements . When , in addition to that , those possessing the advent of modern biotechnology there is a need to the materials claim intellectual property rights on dubious update and clarify the legal situation of these resources . inventive and industrial application grounds , the result is 5 The recently adopted International Treaty on Plant what we call biopiracy . Biopiracy , is probably one of the Genetic Resources for Food and Agriculture ( ï쳌© ï쳌´ ï쳌° ï쳌§ ï쳌² ï쳌¦ ï쳌¡ ) major threats to the viability of legitimate bioprospecting is a step forward in this direction . This is one of the most agreements . Thus , although this report deals mainly with important multilateral events taking place after Rio and ï쳌¡ ï쳌¢ ï쳌³ , we firmly believe that illegitimate and / or illegal pat - before Johannesburg and it endorses the ï쳌£ ï쳌¢ ï쳌¤ principles . enting practices , particularly in the United States , remain The implications of ï쳌© ï쳌´ ï쳌° ï쳌§ ï쳌² ï쳌¦ ï쳌¡ for bioprospecting in the food a fundamental obstacle to the legitimacy of bioprospect - and agriculture sector are hard to evaluate yet , but there is ing . Such patenting practices have to stop . Otherwise , an opportunity for greater coordination among ministries those who see biopiracy and bioprospecting as the same ï?? ï?? ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : M ï쳌¥ ï쳌¸ ï쳌© ï쳌£ ï쳌¯ There are many other patents in the United States and Resources Europe that involve Mexican genetic resources and / or traditional knowledge or make use of them in their devel - opment . Some of them are clearly illegal and illegitimate , Natural but the picture is far from being black and white . Box ï?? presents examples of patents to illustrate some of these is - sues . S ï쳌¡ ï쳌² ï쳌µ ï쳌« ï쳌¨ ï?¡ ï쳌® et al . ( ï?? ï?? ï?? ï?? ) recognized that the issue of Biological genetic resources is the « subject of debate since it involves intellectual property rights , strong economic interests , the ethics of human legacy and the limits to the commercial - ization of life » . These debates are far from being settled Genetic and current activities within the ï쳌£ ï쳌¢ ï쳌¤ , ï쳌¦ ï쳌¡ ï쳌¯ , the World Trade Organization ( ï쳌· ï쳌´ ï쳌¯ ) , and the World Intellectual Property Organization ( ï쳌· ï쳌© ï쳌° ï쳌¯ ) will have to deal with the full extent of Change in these issues in a comprehensive manner in order to achieve jurisdiction coherence at the multilateral level . Interesting work is be - Appropriation processes are different , ing developed by ï쳌· ï쳌© ï쳌° ï쳌¯ in relation to traditional knowledge as are rights and obligations . and genetic resources ( ï쳌· ï쳌© ï쳌° ï쳌¯ ï?? ï?? ï?? ï?? ) . For the authors of this report , biopiracy means the Figure ï?? . Natural , biological and genetic resources . appropriation of genetic resources through noninventive Although genetic resources are a part of biological patents , without the prior informed consent of the owners resources and these are a central component of natural of the resource or knowledge involved , and without effec - resources , the fact remains that the processes of appro - tive distribution of contractually agreed benefit sharing . priation are different and so are the rights and obligations Bioprospecting , on the other hand , may be composed of a related to them . superficially similar set of actions , but it declares its inten - tion , it registers patents with clear inventive steps , claims , and industrial applications , and it seeks and obtains previ - thing will have a relevant point . As an example , consider ous informed consent and proposes specific schemes for the case of the ï쳌µ ï쳌³ ï쳌¡ patent granted on the Enola bean in benefit sharing . There are those who assume that biopiracy which initial access was from a public market in Mexico . and bioprospecting are the same thing ( see C ï쳌µ ï쳌¡ ï쳌¤ ï쳌¥ ï쳌² ï쳌® ï쳌¯ ï쳌³ The biological materials were taken into the United States A ï쳌§ ï쳌² ï쳌¡ ï쳌² ï쳌© ï쳌¯ ï쳌³ ï?? ï?? ï?? ï?? , a volume fully dedicated to the issue that without permission . In addition , the patent lacks innova - reflects part of the social perception on bioprospecting tion worthy of qualifying as invention . A definitive legal in Mexico ) . This sets a complex political scene for ï쳌¡ ï쳌¢ ï쳌³ decision will not be reached until after the request to re - projects , not only in our country but in other regions of examine posed by the Center for International Tropical the world as well . Agriculture is settled . The ayahuasca case is another ex - To begin with , we will briefly describe the national ample of this issue , because a clearly illegitimate patent legal landscape and comment on the social and cultural was re - examined and finally reinstated by the ï쳌µ ï쳌³ ï쳌¡ Patent context of ï쳌¡ ï쳌¢ ï쳌³ projects in Mexico . We will then review 7 and Trademark Office ( ï쳌µ ï쳌³ ï쳌° ï쳌´ ï쳌¯ ) , after a costly process . three projects implemented in Mexico . Finally , we describe This is worrying precedent that should alert academics current legal initiatives on access to genetic resources , and civil society within the ï쳌µ ï쳌³ ï쳌¡ . followed by conclusions and recommendations . Legal Basis for Access and Benefit Sharing in Mexican Law 8 to impose upon private property the conditions dictated by The Constitution public interest , and to regulate , for social benefit , the use The basic Constitutional framework related to ï쳌¡ ï쳌¢ ï쳌³ is of the natural elements susceptible of appropriation , with found in four articles , because the issue crosses sector the aim of distributing fairly public assets , [ and ] care for its boundaries . It is important to note that in Mexico , ï쳌£ ï쳌¢ ï쳌¤ conservation â?¦ . Therefore , the necessary measures will be obligations are above sector - specific federal laws but dictated to â?¦ preserve and restore ecological equilibrium â?¦ 9 below the Constitution ( Supreme Court ï?? ï?? ï?? ï?? ) . The most and to avoid the destruction of the natural elements . â?쳌 relevant Constitutional article in this context is ï?? ï?? , which Despite the fact that this article indeed explains the establishes the basis of land tenure and natural resource sovereignty of the State over certain natural resources , use ( M ï쳌¥ ï쳌¸ ï쳌© ï쳌£ ï쳌¡ ï쳌® C ï쳌¯ ï쳌® ï쳌§ ï쳌² ï쳌¥ ï쳌³ ï쳌³ ï?? ï?? ï?? ï?? ) . This article regulates land such as oil or water , for example , it is far from clear that property rights , be they private or collective , and it defines this includes all natural resources . The concept of eminent public interest over specific elements . In its third paragraph domain over property on behalf of the State ( the concept it states that â?? the nation shall have at anytime the authority of original public property ) is not sufficient to determine ï?? ï?? ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ 10 a priori public property over any natural resource . When is a constitutional interpretation relating to the concept of not explicitly stated , Article ï?? ï?? delegates such decisions to original public property . ordinary legislation ( see Figure ï?? ) . If , in turn , subsidiary Article ï?? ï?? regulates antitrust rules , one of the exemp - instruments do not make an explicit decision , then there tions being intellectual property rights : â?? The privileges is an â?? apparent gap â?쳌 that is solved by going back to the that , for a certain period of time , are granted to . . . inven - concept of original property of the State . Thus , there are tors and innovators of any addition shall not constitute two complementary arguments to affirm that genetic re - a monopoly â?쳌 ( M ï쳌¥ ï쳌¸ ï쳌© ï쳌£ ï쳌¡ ï쳌® C ï쳌¯ ï쳌® ï쳌§ ï쳌² ï쳌¥ ï쳌³ ï쳌³ ï?? ï?? ï?? ï?? ) . This article , sources are public property but private individuals have the along with article ï?? ï?? ( M ï쳌¥ ï쳌¸ ï쳌© ï쳌£ ï쳌¡ ï쳌® C ï쳌¯ ï쳌® ï쳌§ ï쳌² ï쳌¥ ï쳌³ ï쳌³ ï?? ï?? ï?? ï?? ) indi - right to use them . One is the applicability of the ï쳌· ï쳌§ ï쳌¡ that cates three ways in which an activity can be affected by recognizes the right to make a sustainable use . The other a special public regimen . These are the strategic areas , Box 1 . Examples of USA patents related to Mexican genetic resources or traditional knowledge In most biotechnological development with an industrial market and belong to a local landrace named Mayocoba of purpose , the usual final step in the appropriation process is common bean ( Phaseolus vulgaris ) . Two generations of self the granting of a patent . Problems in this important link of the pollination fixed the yellow color but inbreeding produced chain weaken the whole structure of bioprospecting practices problems of pod shattering or adherence to the plants . proposed by the ï쳌£ ï쳌¢ ï쳌¤ framework . The issuing of patents on Selection was directed to eliminate this problem rather than living organisms , ï쳌¤ ï쳌® ï쳌¡ sequences , enzymes , etc . , with doubt - to produce a bean of different color . However , the claims of ful invention involved and broad industrial application claims the patent are only related to the germplasm deposited and is one of the facets that polarize and confuse discussions on to the color of the bean . This patent is being re - examined in bioprospecting . response to an official request by the International Center for Both recent and older patents involving Mexican genetic Tropical Agriculture , a member of the Consultative Group resources or traditional knowledge show some of the gray on International Agricultural Research . More information is areas in which we have to deepen our understanding and available at http : / / www.ciat / cgiar / org . enhance and tighten the criteria of novelty and invention in USPTO ï?? ï?? ï?? ï?? ï?? ï?? ï?? , ï?? ï?? May ï?? ï?? ï?? ï?? . Method and materials patent evaluation related to life systems . Following are three for conferring Tripsacum genes in maize . Mary Wilkes examples that illustrate important issues . Regretfully , they Eubanks . are only a part of the picture of a much wider , more complex This patent shows inventive steps that seem original and process of granting temporal privileges to so - called inventions non - obvious but which are impossible to achieve without the that only redistribute capital investment or simulate creativity germplasm of an endemic species from Manantlán , Mexico through ideological discourse and technical jargon.Although that is at the core of the germplasm of maize . Setting aside the living resource - related patents are particularly problematic validity of the invention , access to the genetic resource ocurred in this regard , S ï쳌¨ ï쳌µ ï쳌¬ ï쳌­ ï쳌¡ ï쳌® ( ï?? ï?? ï?? ï?? ) has nicely described other prior to ï쳌£ ï쳌¢ ï쳌¤ and relatively independent of the use of traditional â?? absurdities â?쳌 that should also worry ï쳌µ ï쳌³ ï쳌¡ society ( civil , in - knowledge and practices . This patent raises the issue of the dustrial , and academic ) . legal situation of biological materials collected before the entry The comments on the patents reflect our opinion , and the into force of the ï쳌£ ï쳌¢ ï쳌¤ and the possibilities of negotiating benefit examples are intended to illustrate some of the issues and sharing even after a patent has been granted . represent a spectrum of patenting practices . At least one of the patents , the so - called Enola bean , is currently in review in USPTO Plant Patent ï?? ï?? ï?? ï?? , ï?? ï?? August ï?? ï?? ï?? ï?? . Camote plant . response to an objection . Regretfully , examples such as this Steven Pollock . abound , but this is not the place to suggest a thorough revi - The abstract speaks by itself : â?? A new and distinct camote sion . It is , in fact , one of our recommendations to establish plant has been discovered . The novel psychotropic plant is a an interdisciplinary and intersectorial group to evaluate the variety of the subtropical terricolous Basidiomycete fungus extent of this situation regarding Mexican genetic resources Psylocibe tampanensis â?쳌 , and it shows the subtleties of the use and traditional knowledge in the patent offices of several of traditional knowledge as a guide . The description recog - countries . Collaboration among countries on this issue would nizes existing Mazatec knowledge and practices relating to the certainly reduce the costs of monitoring . â?? derrumbe â?쳌 fungus and builds upon Pollockâ??s own knowledge These examples show that we need to ask if it makes sense as a mycologist . He also refers to collaboration with Mexican to recognize patents at all . Invention is hard to distinguish mycologist Guzman . It is important to note that germplasm from discovery , and many patents have unclear industrial involved with the patent was not collected in Mexico , but in applications , use genetic resources without recognizing third - Tampa , Florida . Thus this patent did not involve access to party rights over them , or fail to recognize the contribution Mexican genetic resources but involved Mazatec traditional of genetic resources and traditional knowledge . knowledge . The question is whether it really constitutes an invention or a discovery ( as the abstracts indicates ) and if USPTO ï?? ï?? ï?? ï?? ï?? ï?? ï?? , ï?? April ï?? ï?? ï?? ï?? . Field bean cultivar named the description and isolation of a plant ( fungus ) constitute Enola . Larry Proctor . inventive steps . This patent has expired already , and we are This patent â?? relates to a new field bean variety that produces not aware of further inventive developments deriving from it , distinctly colored yellow seed which remain relatively unchanged by season â?쳌 . Seeds were bought in a Mexican nor do we know if it gained its owner economic benefits . ï?? ï?? ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : M ï쳌¥ ï쳌¸ ï쳌© ï쳌£ ï쳌¯ the priority areas and the public services . The areas con - munity , municipality , people , and multiethnic region ( S ï쳌´ ï쳌¡ ï쳌¶ ï쳌¥ ï쳌® ï쳌¨ ï쳌¡ ï쳌§ ï쳌¥ ï쳌® ï?? ï?? ï?? ï?? ) . These rights should also recog - sidered strategic and of exclusive State participation are nize the specific characteristics of traditional medicine and oil extraction , postal services , and extraction and use of traditional ecological knowledge , among others . Ongoing radioactive minerals . On the other hand , some priority work is taking place on issues derived fromArticle ï?? j of the areas are satellite communications and train transport . ï쳌£ ï쳌¢ ï쳌¤ and the International Labor Organization Agreement These priority areas are given special public scrutiny , but ï?? ï?? ï?? related to tribal and indigenous peoples in indepen - private individuals can join in their commercial exploita - dent countries . In Mexico , the indigenous uprising of ï?? ï?? ï?? ï?? tion . The use of genetic resources is not affected by any confronted the nationâ??s conscience , and subsequent nego - of these public regimes . Although many people think that tiations and mobilization led to the recent amendments of genetic resources should be considered a priority area by Article ï?? of the Constitution in the year ï?? ï?? ï?? ï?? . According to Mexico , this is not yet reflected in the legal framework . C ï쳌¯ ï쳌³ ï쳌³ ï쳌© ï쳌¯ - D ï쳌© ï쳌¡ ï쳌º ( ï?? ï?? ï?? ï?? ) the amendment recognized two new We agree that genetic resources should be regarded at least categories of subjects of the law : indigenous â?? peoples â?쳌 as a priority . Furthermore , these resources , after careful and â?? communities â?쳌 ( M ï쳌¥ ï쳌¸ ï쳌© ï쳌£ ï쳌¡ ï쳌® C ï쳌¯ ï쳌® ï쳌§ ï쳌² ï쳌¥ ï쳌³ ï쳌³ ï?? ï?? ï?? ï?? ) . This thought and debate , could be regarded as strategic , be - type of community is different from that established in cause our megadiversity indicates that there is important Article ï?? ï?? as an agrarian community , which refers to a â?? wealth â?쳌 involved , because of the fundamental role that collective land - ownership regime , in which decisions genetic resources has played in our survival as cultures , have to be taken by the Assembly . Under the amendment , peoples , and a nation , and because of their enormous value section A of this article establishes that â?? this Constitution for biotechnology development . However , Article ï?? ï?? of the recognizes and warrants the right of indigenous peoples Constitution recognizes that such consideration may be and communities to self determination and therefore included in ordinary legislation . The rights of indigenous the autonomy to . . . preserve and enrich their languages , peoples over their knowledge and natural resources add knowledge , and all the elements that constitute their culture complexity to this issue . Rights relating to them should and identity â?쳌 . Section B of this same article adds that the recognize at least four nested levels of autonomy : com - a ) Allocation of Property Right Public property Property by accession Right of use e.g . , Fisheries Act e.g . , Forestry Act e.g . , Wildlife General Act Right of disposition b ) Right to enjoy Right to use c ) No No Explicit Federal Explicit Original Constitution decision legislation decision public property Yes Yes Prevails Prevails Figure ï?? . Allocation of property rights and natural resources . a ) Sectorial legislation uses three basic techniques to allocate property rights , each of them set forth by different Acts . b ) Property rights are comprised of three basic components , which can be separated , therefore , it is possible to allocate to private individuals the rights of the lower category . c ) Decision schemes to determine the rights that exist over a natural resource : If the Constitution yields no explicit decision , then Federal legislation is applied ; if that still does not resolve the issue , then we face an apparent gap , but legal hermeneutics resolves it by relying on the concept of original public property . ï?? ï?? ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ 11 Federation , the States and the Municipalities â?? in order Thus , the Constitution establishes a set of general to reduce the needs that affect the indigenous peoples and rules regarding land property , natural resource manage - communities , shall have the obligation to â?¦ support the ment , indigenous peoples , and intellectual property rights productive activities and sustainable development of the that must be elaborated further since new realities need to indigenous communities through actions that will enable be faced . Although in many cases practical decisions can them to reach the sufficiency of their economic incomes ; be made in ordinary legislation , there are some issues that the application of incentives for private and public invest - are too important to be dealt with in secondary legislation , ment that would foster job source creation ; the introduction such as the clarification of property rights over genetic of technologies for raising their own productive capacity ; resources and the recognition of the collective rights of as well as to ensure the equitable access to distribution indigenous peoples . and commercialization systems â?쳌 . Despite the fact that the amendment is a step forward , the reform will be merely a Federal Legislation programmatic list if it is not properly defined in secondary In Mexican legislation , ï쳌¡ ï쳌¢ ï쳌³ only began to be explicitly legislation . Although the reforms superficially indicate a regulated in ï?? ï?? ï?? ï?? . Article ï?? ï?? ï쳌¢ ï쳌© ï쳌³ of the ï쳌¥ ï쳌¥ ï쳌¥ ï쳌° ï쳌§ ï쳌¡ was the move towards recognition of collective rights to indigenous first step in this direction ( M ï쳌¥ ï쳌¸ ï쳌© ï쳌£ ï쳌¡ ï쳌® C ï쳌¯ ï쳌® ï쳌§ ï쳌² ï쳌¥ ï쳌³ ï쳌³ ï?? ï?? ï?? ï?? b ) , peoples in Mexico , the fact remains that part of the benefi - setting the principles but still lacking specific guidelines , ciaries oppose to this reform and are currently demanding regulations , or standards . cancellation of the amendments and respect for the original 12 Currently there are three federal environmental laws reform proposed after the peace talks with the Zapatistas . that regulate access to genetic resources ( Table ï?? ) : the The outcome of these legal and political objections might ï쳌¥ ï쳌¥ ï쳌¥ ï쳌° ï쳌§ ï쳌¡ , the ï쳌· ï쳌§ ï쳌¡ , and ï쳌³ ï쳌¦ ï쳌¤ ï쳌§ ï쳌¡ ( M ï쳌¥ ï쳌¸ ï쳌© ï쳌£ ï쳌¡ ï쳌® C ï쳌¯ ï쳌® ï쳌§ ï쳌² ï쳌¥ ï쳌³ ï쳌³ ï?? ï?? ï?? ï?? ) . have important implications for ï쳌¡ ï쳌¢ ï쳌³ in Mexico , particularly In addition , there are three relevant federal laws that relate when it involves genetic resources related to traditional knowledge or indigenous lands and territories . directly to this issue : the Industrial Property Act , the Plant Table ï?? . Overview of existing laws and regulations with relevance to ï쳌¡ ï쳌¢ ï쳌³ issues Constitution for scientific , commercial and biotechnological purposes . Article ï?? . Recognizes legal standing for two new categories : Requires an authorization or a notification , both subject to the indigenous â?? peoples â?쳌 and â?? communities â?쳌 . ï쳌° ï쳌© ï쳌£ of the owner of the land . It declares void any registration Article ï?? ï?? . Defines scope of strategic and priority areas and including patents that do not acknowledge the rights of public services , in which genetic resources are not included . indigenous people on the ownership , knowledge or use of local Article ï?? ï?? . Grants and regulates the right to private property varieties . If traditional knowledge is to be used there must be and defines public property over certain natural resources . recognition of the ownership on behalf of the communities , an Does not explicitly define proprietary rights over genetic access agreement and proof of ï쳌° ï쳌© ï쳌£ . It calls for the promotion resources . and respect of biological traditional knowledge and gives Article ï?? ï?? . States the antitrust rule and intellectual property special protection to endemic and threatened species . rights as an exemption . Industrial Property Act ( ï쳌© ï쳌° ï쳌¡ ) Article ï?? ï?? ( ï쳌¸ ï쳌© ï쳌¸ - ï쳌§ ) . Empowers the State to regulate the use Article ï?? ï?? ( ï쳌© ï쳌© ) . Establishes the positive requirements for of natural elements and empowers the Federal Congress patenting ( novelty , inventive step , and industrial application ) , regarding Environmental Legislation . and states an exclusion of patenting over biological and Ecological Equilibrium and Environmental Protection genetic material â?? as found in nature â?쳌 . General Act ( ï쳌¥ ï쳌¥ ï쳌¥ ï쳌° ï쳌§ ï쳌¡ ) Article ï?? ï?? . Excludes from patenting any discovery . Article ï?? ( ï쳌© ï쳌© ï쳌© ) . Use of genetic resources is recognized as â?? of Plant Varieties Federal Act public interest â?쳌 . Scope includes all species , but regarding Grants rights to plant breeders for varieties that are new , aquatic species , coordination with other sectors is ordered . stable , distinct , and homogeneous . Does not address ï쳌¡ ï쳌¢ ï쳌³ . Article ï?? ï?? . Scientific collection requires authorization , not ï쳌® ï쳌¯ ï쳌­ - ï?? ï?? ï?? - ï쳌¥ ï쳌£ ï쳌¯ ï쳌¬ - ï?? ï?? ï?? ï?? extended to biotechnological purposes . Economic use of Regulates scientific collecting . Follows ï쳌· ï쳌§ ï쳌¡ and ï쳌¥ ï쳌¥ ï쳌¥ ï쳌° ï쳌§ ï쳌¡ biological resources requires authorization and the explicit consent of the owner of the land has to be obtained . with technical detail , explicitly excludes forestry related Article ï?? ï?? - ï쳌¢ ï쳌© ï쳌³ . Biotechnological use requires authorization , germplasm , and contemplates possible change of purpose from subject to the explicit prior informed consent of the owner of scientific to biotechnological applications . the land , who has the right to an equal share of benefits . Criminal Code Wildlife General Act ( ï쳌· ï쳌§ ï쳌¡ ) Article ï?? ï?? ï?? of the code punishes with prison and a fine This law regulates collecting activities for scientific purposes . any individual who illegally â?? executes any activity with Its scope limited to wild flora and fauna , excluding aquatic traffic purposes , or captures , possesses , transports , gathers , and domesticated species . It also excludes access to genetic introduces to the country or extracts from it , any specimen resources for biotechnological development and refers this â?¦ and other genetic resources â?¦ regulated by any international kind of use to other national or international legal instruments . treaty of which Mexico ( is ) Party â?쳌 . Furthermore , â?? additional punishment will be applied â?¦ when the â?¦ described activities Sustainable Forestry Development General Act ( ï쳌³ ï쳌¦ ï쳌¤ ï쳌§ ï쳌¡ ) Scope related to forest resources . Regulates collecting â?¦ are executed with commercial purpose â?쳌 . ï?? ï?? ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : M ï쳌¥ ï쳌¸ ï쳌© ï쳌£ ï쳌¯ Variety Federal Act , and the Criminal Code ( M ï쳌¥ ï쳌¸ ï쳌© ï쳌£ ï쳌¡ ï쳌® Collecting for Scientific Purposes C ï쳌¯ ï쳌® ï쳌§ ï쳌² ï쳌¥ ï쳌³ ï쳌³ ï?? ï?? ï?? ï?? ) . Furthermore , there are dispositions in the Scientific collection is also regulated in Article ï?? ï?? of ï쳌² ï쳌³ ï쳌¤ ï쳌¡ that are relevant to traditional knowledge . Likewise , ï쳌¥ ï쳌¥ ï쳌¥ ï쳌° ï쳌§ ï쳌¡ , which states that collection of wild flora and most of the novel provisions of the ï쳌³ ï쳌¦ ï쳌¤ ï쳌§ ï쳌¡ are related to fauna specimens , as well as other biological resources traditional knowledge rather than to ï쳌¡ ï쳌¢ ï쳌³ in general ( see ( which by definition include genetic resources ) , requires Table ï?? ) . an authorization . This authorization cannot be extended In the ï쳌¥ ï쳌¥ ï쳌¥ ï쳌° ï쳌§ ï쳌¡ , the use of genetic resources is consid - 13 to biotechnological purposes , and it shall be ensured that ered of public interest , which means that the State can research results will be available to the public , a provi - exercise an authority that supersedes any individual interest sion that needs to be evaluated with regard to intellectual on behalf of the higher interest of society . This public inter - property . est must be protected and exercise of individuals â?? rights As for the ï쳌· ï쳌§ ï쳌¡ article ï?? ï?? states that before any col - prejudicial to it must be avoided . This translates into an lecting can be carried out the explicit ï쳌° ï쳌© ï쳌£ of the owner of area of State discretion in which the authority can affect a the land ( where the resources is located ) must be obtained . specific activity , as the State does when declaring a Natural Scientific collection authorizations shall not include bio - Protected Area over private or collectively owned land . technology applications , nor commercial purposes and will Thus , the regulation of access to genetic resources is be granted only when the viability of the populations , spe - within the jurisdiction of Federal authorities . However , cies , habitats , and ecosystems is not compromised . These some transfer of faculties to regulate these resources could authorizations are granted in two modalities : a permit by be agreed upon between federal and state governments specific project or a license for a researcher with a specific through coordination agreements , which would have to line of research . Both require report submissions and de - meet certain requirements . There are no current examples posit of at least one duplicate of the collected material in of such agreements regarding ï쳌¡ ï쳌¢ ï쳌³ . a Mexican institution or scientific collection . The scope of the ï쳌¥ ï쳌¥ ï쳌¥ ï쳌° ï쳌§ ï쳌¡ includes the use of all spe - ComplementingArticle ï?? ï?? there is an Official Mexican cies , but aquatic species are also regulated by the Fisheries Standard that regulates scientific collection ( ï쳌® ï쳌¯ ï쳌­ - ï?? ï?? ï?? - Act , the National Water Act , and relevant international ï쳌¥ ï쳌£ ï쳌¯ ï쳌¬ - ï?? ï?? ï?? ï?? ) . It basically follows the regulations of the ï쳌· ï쳌§ ï쳌¡ treaties . The few provisions of the ï쳌³ ï쳌¦ ï쳌¤ ï쳌§ ï쳌¡ related to ï쳌¡ ï쳌¢ ï쳌³ in ( with technical detail that it is not relevant here ) , with the general ( and not to traditional knowledge ) do not change exception that it contemplates a change of purpose from the basic scheme of access stated by the ï쳌¥ ï쳌¥ ï쳌¥ ï쳌° ï쳌§ ï쳌¡ and the scientific to biotechnological applications , recognizing ï쳌· ï쳌§ ï쳌¡ . Likewise , an authorization is required as well as the that scientific collections can later be used for industrial 14 ï쳌° ï쳌© ï쳌£ of the owner of the land . It only adds a simplified applications . In this case it mandates a new declaration procedure in case of collections done by the owner of stating a change of purpose , thus setting the stage for the land or by public agencies where only a notification new ï쳌° ï쳌© ï쳌£ and ï쳌¡ ï쳌¢ ï쳌³ agreements . It is interesting to note that and the ï쳌° ï쳌© ï쳌£ are required . There is however , an interesting this simple measure may prove to have a low transaction feature of the ï쳌³ ï쳌¦ ï쳌¤ ï쳌§ ï쳌¡ . By means of definitions it includes cost because the change in the ï쳌° ï쳌© ï쳌£ and the negotiation in its scope the ï쳌¡ ï쳌¢ ï쳌³ for biotechnological purposes of wild of the ï쳌¡ ï쳌¢ ï쳌³ agreement would happen only after a finding animals and microorganisms found in forest ecosystems that merited further development of the genetic resource . which include a significant proportion of Mexicoâ??s ter - Thus , scientific collection is regulated and differentiated restrial biodiversity . from collecting with biotechnological or economic pur - 15 poses , but the distinction is not always easy to follow . General Regulation of Collecting Activities The possibility of a future change of purpose is realistic , but it could create a sort of loophole in which ï쳌¡ ï쳌¢ ï쳌³ and ï쳌° ï쳌© ï쳌£ Collection activity can have three main application pur - 16 are not faced at the onset but are postponed . This Official poses : scientific , economic , and biotechnological . In Mexican Standard also confirms that for collecting aquatic particular , the ï쳌· ï쳌§ ï쳌¡ ( M ï쳌¥ ï쳌¸ ï쳌© ï쳌£ ï쳌¡ ï쳌® C ï쳌¯ ï쳌® ï쳌§ ï쳌² ï쳌¥ ï쳌³ ï쳌³ ï?? ï?? ï?? ï?? ) contem - species a special fishery permit is required , pursuant to plates a wider and more explicit classification of objec - 17 other applicable legislation . tives or purposes that exclude biotechnology . Collection with economic purposes is regulated in Article ï?? ï?? of the ï쳌¥ ï쳌¥ ï쳌¥ ï쳌° ï쳌§ ï쳌¡ , which states that the use of wild flora and fauna Collecting for Biotechnological specimens in economic activities will be authorized when Development Purposes the individuals guarantee their controlled reproduction or captivity and semi - captivity management , or , in the case Biotechnological purposes are regulated in Article ï?? ï?? ï쳌¢ ï쳌© ï쳌³ of wild populations , the extraction rate should be less than of the ï쳌¥ ï쳌¥ ï쳌¥ ï쳌° ï쳌§ ï쳌¡ , which states that â?? the use of flora and fauna the natural increase ( a simple definition of sustainable use ) . specimens , as well as other biological resources , requires Such use requires the explicit consent of the proprietor or an authorization , which can only be issued if the explicit legitimate possessor of the land where the individuals of ï쳌° ï쳌© ï쳌£ is granted by the owner or legitimate possessor of the a species or population are located . Thus , this regulation land where the resources are located who shall have the clearly intends biological resource use . right to the equal sharing of the benefits arising from the ï?? ï?? ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ use of the resources â?쳌 . It is important to note that until re - posals to extend the disclosure requirements in intellectual property right applications , such as the one proposed by cently this was the only article within the entire Mexican the Swiss , which calls for a requirement to disclose the legal framework that directly regulated bioprospecting . origin , if known , of the genetic materials and traditional Despite the fact that it comprises two elements stated by knowledge used in the inventions . These amendments are the ï쳌£ ï쳌¢ ï쳌¤ ( the ï쳌° ï쳌© ï쳌£ and the benefit - sharing provisions ) , there fully compatible with existing intellectual property rights are many aspects of ï쳌¡ ï쳌¢ ï쳌³ that at the national level are left to principles since they constitute part of the description of the authorities for interpretation and effective implementa - the invention . However , these proposals stop short of re - tion . This article does not make any reference to the third quiring evidence of prior informed consent , which tends fundamental element of access outlined in the ï쳌£ ï쳌¢ ï쳌¤ , the to be considered too complex and costly to be feasible . â?? mutually agreed terms â?쳌 which is commonly understood to The development of a certificate of legal provenance have a contractual nature . Due to this lack of reference the would aid in this regard , facilitating the implementation law reserves this element for private development which of stricter and more comprehensive disclosure require - constitutes an important signal to the market . This feature ments in a more cost effective way . The decisions adopted of the current legal framework has been criticized and can by the Seventh Conference of the Parties ( ï쳌£ ï쳌¯ ï쳌° ) to the ï쳌£ ï쳌¢ ï쳌¤ be read in contrast with the proposed initiatives of law . in Kuala Lumpur in ï?? ï?? ï?? ï?? indicate the political willing - It is worth noting that while the ï쳌£ ï쳌¢ ï쳌¤ establishes rights ness to start development of some sort of international and obligations among parties , Article ï?? ï?? ï쳌¢ ï쳌© ï쳌³ also gives the certificate for genetic resources which could facilitate the right to grant ï쳌° ï쳌© ï쳌£ ( and therefore to receive the benefits ) to proof of legal acquisition of genetic materials at various the owners of land . This transfer of benefits has intrinsic stages of their use . problems , because it amplifies the consequences of own - ership of the resource , which is resolved in Mexico by granting rights of use . However , the problem of the trans - Ex Situ Collections boundary nature of genetic resources is not acknowledged . Under such conditions , when the owners of the land grant a The ï쳌¥ ï쳌¥ ï쳌¥ ï쳌° ï쳌§ ï쳌¡ does not regulate ex situ collections . Regarding ï쳌° ï쳌© ï쳌£ , they may be affecting rights over genetic resources also the ï쳌· ï쳌§ ï쳌¡ , a few articles regulate access to ex situ collections found in neighboring fields . Furthermore , with regard to indirectly : any scientific and museum collection , whether the distribution of benefits , attaching them to the granting private or public , must be registered and permanently of ï쳌° ï쳌© ï쳌£ has exclusion implications , since benefit - sharing ar - updated in an official record . Once registered , they can rangements compensate only the person ( s ) granting the ï쳌° ï쳌© ï쳌£ be exempted , under specific circumstances , from certain and not other custodians of genetic resources . It could be obligations regulating proof of legal provenance as long argued that this means that in Mexican Law there are two as they do not have any biotechnological or commercial PICs , one given by the Mexican Government in the form purposes . In addition to severe punishments outlined by of a collecting permit and another given by the owners of the Criminal Code in the next section , article ï?? ï?? ï?? of ï쳌· ï쳌§ ï쳌¡ the land . In the first case the interest of society is protected punishes as an administrative infringement the lack of due and in the second , the interest of the owner ( s ) of the land . permits for the use of biological material for biotechno - Thus , it is fundamental to address this situation in depth logical applications . for any future comprehensive legislative effort . As already indicated , the other environmental law regu - The Criminal Code lating access to genetic resources is the ï쳌· ï쳌§ ï쳌¡ . It establishes that the right to make a sustainable use of the wildlife The Criminal Code ( M ï쳌¥ ï쳌¸ ï쳌© ï쳌£ ï쳌¡ ï쳌® C ï쳌¯ ï쳌® ï쳌§ ï쳌² ï쳌¥ ï쳌³ ï쳌³ ï?? ï?? ï?? ï?? ) punishes specimens found within the boundaries of a property is with prison from one to ten years and a fine of ï?? ï?? ï?? to ï?? , ï?? ï?? ï?? 18 granted to the owner of the land . This is important re - minimum daily wages to those who â?? illegally execute any garding the property status of genetic resources because activity with traffic purposes , or capture , possess , transport , the Constitution does not define them as private or public gather , introduce to the country , or extract from it , any and ordinary legislation does not take a classic or strict specimen , its products , its subproducts , and other genetic property decision but assigns a right to sustainable use on resources , of any wild flora and fauna species , terrestrial behalf of landowners . species , or aquatic species on temporary prohibition , con - The ï쳌· ï쳌§ ï쳌¡ requires proof of legal provenance for regis - sidered endemic , threatened , endangered , subject to spe - tration and authorizations related to biological materials cial protection , or regulated by any international treaty of 19 20 of wild species outside their habitat . This disposition which Mexico has become a Party â?쳌 . Furthermore , â?? an exemplifies the use of legal provenance as an instrument to additional punishment will be applied when the described regulate possession of biological materials such as wildlife activities are executed in or affect a natural protected area , cargo or hunting trophies . By analogy , a similar approach or when they are executed with commercial purpose â?쳌 . could be taken in the process to obtain intellectual property Considering the models of criminal behavior proposed rights such as patents : including proof of having complied by Economic Analysis of Law ( P ï쳌¯ ï쳌³ ï쳌® ï쳌¥ ï쳌² ï?? ï?? ï?? ï?? ) a person is with the ï쳌¡ ï쳌¢ ï쳌³ conditions of the provider country or region . assumed to act rationally on the basis of costs and ben - It is interesting to note in this regard the emergence of pro - efits of legal and illegal opportunities . Particularly , most ï?? ï?? ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : M ï쳌¥ ï쳌¸ ï쳌© ï쳌£ ï쳌¯ studies corroborate the hypothesis that the probability of ï?? ï?? ï?? ï?? ) in Mexico is relevant because it includes the pos - punishment is more important than its severity as a deter - sibility of obtaining patents over genetic resources . In rent effect on crime . Therefore , in theory , this regulation any case , patents should comply with the requirements should promote compliance with current legal obligations . of novelty , inventive step , and industrial application , and However , collecting seeds or microorganisms is almost there is an exception to patenting of biological and genetic impossible to control ( a tourist can take samples back to material â?? as it is found in nature â?쳌 . The criterion with which his country with almost no difficulty ) . If caught in Mexico , this exception is applied is highly relevant : the current he would face the aforementioned punishment , but the practice by the patent office in Mexico is to consider that likelihood of such an event happening is so slim that his once biological or genetic material has been isolated and 21 chances are good of taking the material without complying characterized , it is no longer â?? as it is found in nature â?쳌 . with our regulation . Such interpretation is not shared by the authors of this work On the other hand , and as will be seen below , if those nor do we think that it should be a common practice ( this who try to comply with the law face social objections , position is also found in C ï쳌¯ ï쳌² ï쳌² ï쳌¥ ï쳌¡ ( ï?? ï?? ï?? ï?? ) and ï쳌· ï쳌´ ï쳌¯ ( ï?? ï?? ï?? ï?? ) ) , legal confusions , and high transaction costs , then the mes - because isolating and characterizing biological materials sage that Mexico is sending to the world is that to ask for is not an activity directly relevant to the creativity of the permission can be much more costly than simply taking invention and such protections really recognize capital the material . The punishment in the Criminal Code should investment rather than invention . Therefore if a patent is help prevent such actions , but the reality of the distribu - granted on isolated and characterized materials then pro - tion of living species and the ease with which they can tection is being granted to discoveries , which are expressly be collected makes it unlikely that it will be an effective excluded by Article ï?? ï?? of the ï쳌© ï쳌° ï쳌¡ . This is an issue of the measure by itself . in - depth patent review process that has to be resolved . What needs to be clearly defined is that a product Plant Breeders â?? Rights and Patents derived from isolating and describing the functions of biological materials does not comply with the inventive The Plant Variety Protection Act ( M ï쳌¥ ï쳌¸ ï쳌© ï쳌£ ï쳌¡ ï쳌® C ï쳌¯ ï쳌® ï쳌§ ï쳌² ï쳌¥ ï쳌³ ï쳌³ step requirement , and that inventions worthy of patents ï?? ï?? ï?? ï?? a ) gives property rights to plant breeders for a plant should involve modifications to the original material that variety that is new , stable , distinct , and homogeneous . This are novel , nonobvious , and contribute decisively to the is relevant in the ï쳌¡ ï쳌¢ ï쳌³ context because it is possible to obtain 22 claimed industrial application . This is a complex mat - plant breeders rights without requiring an â?? inventive step â?쳌 ter in itself . In Box ï?? , three examples are given of patents and under a more relative standard of â?? novelty â?쳌 . Thus , related to â?? Mexican â?쳌 genetic resources or traditional obtaining these rights may be easier and more flexible knowledge . than obtaining a patent and the issue of access regula - The legal principles and regulations described are those tion becomes much more important . In most cases there in force at the time this paper was written . However , it are traditional and time consuming collective practices should be kept in mind that the different ï쳌¡ ï쳌¢ ï쳌³ experiences involved in the domestication or initial selection of wild described occurred when some of these regulations did germplasm . In Mexico this Intellectual Property Rights not even exist . This has to be taken into account when ( ï쳌© ï쳌° ï쳌² ) approach is particularly undeveloped , but it will be reading the cases because not all legal aspects described important to monitor the granting of plant breeders â?? rights above were already in place when the bioprospecting in other countries that use Mexican germplasm . The Industrial PropertyAct ( ï쳌© ï쳌° ï쳌¡ ) ( M ï쳌¥ ï쳌¸ ï쳌© ï쳌£ ï쳌¡ ï쳌® C ï쳌¯ ï쳌® ï쳌§ ï쳌² ï쳌¥ ï쳌³ ï쳌³ projects developed . Social and Cultural Context for ABS Compliance with laws and regulations is only a part of ï?? ï?? ï?? ï?? and ï?? ï?? ï?? ï?? , there were close to ï?? ï?? , ï?? ï?? ï?? documented what is needed to achieve the general objectives of ï쳌¡ ï쳌¢ ï쳌³ : human rights violations of different degrees in rural and contributing to sustainable development and in situ conser - indigenous Mexico ; ï?? ï?? % of them were related to agrarian vation of biodiversity . Institutionality in a wide sense is the conflict ( R ï쳌¡ ï쳌­ ï?­ ï쳌² ï쳌¥ ï쳌º - C ï쳌¡ ï쳌³ ï쳌© ï쳌¬ ï쳌¬ ï쳌¡ ï쳌³ ï?? ï?? ï?? ï?? ) . This shows the degree framework in which ï쳌¡ ï쳌¢ ï쳌³ can contribute to these objectives . of polarization present in rural and indigenous land in When the genetic components of biodiversity are seen as Mexico in regard to land tenure and natural resource use . resources , the question of value creation and recognition Furthermore , half of the agrarian - related human rights becomes fundamental , and the social and cultural realities violations mentioned above happened in Chiapas in the in which this happens are of high importance . years before the Zapatista uprising . Although Mexico is in Mexico faces severe social and political contradictions a process of democratic change , this does not mean that we and tensions in rural areas . This is part of the institu - have solved the agenda of poverty and land and resource tional context that has to be considered when evaluat - use or created mechanisms to solve conflict in rural areas . ing the potential contribution of ï쳌¡ ï쳌¢ ï쳌³ to development This is a reality that has to be taken into account when and conservation in our country . For instance , between thinking of bioprospecting in rural Mexico . ï?? ï?? ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ An additional issue to consider is that a contract that issues . Indigenous and peasant communities own most involves transferring biological materials to another coun - of the land where biodiversity is distributed in Mexico . try is seen by many sectors as a violation of the countryâ??s Contributions by rural population have been historically sovereign rights over its resources . This is a fundamental neglected . Bioprospecting seeks to recognize these con - point in terms of political legitimacy for bioprospecting . tributions and to generate mechanisms to reward them . Although we think that the experiences described below are To do so with legitimacy requires a social and cultural proposals that precisely indicate a sovereign way in which context in which peasants and indigenous communities to implement ï쳌¡ ï쳌¢ ï쳌³ , others see them as another form of piracy have already begun the full appropriation of the values of or as the ongoing sale of the countryâ??s resources . In fact , the their own resources . National Indigenous Congress , one of the two main indig - The objective of ï쳌¡ ï쳌¢ ï쳌³ is to design institutional collabora - enous peoples coalitions in Mexico , has called for a total tion schemes that can address the recognition of the values moratorium on all prospecting ( including minerals , water , that each part contributes in the development of a com - and biodiversity ) in their territories ( H ï쳌¡ ï쳌² ï쳌¶ ï쳌¥ ï쳌¹ ï?? ï?? ï?? ï?? ) . mercially viable product and to distribute the benefits that In many of these discussions and conflicts the main may be obtained according to their relative contributions . issue is one of value : neglected , appropriated , built , or Thus , most ï쳌¡ ï쳌¢ ï쳌³ proposals include components of both the recognized . Value creation and recognition is a complex â?? formal â?쳌 and the â?? informal â?쳌 component of value creation process that involves many different activities . With the and recognition . A strict definition of bioprospecting fo - risk of oversimplifying , Figure ï?? shows some of the cuses on the value of â?? formal â?쳌 components and speaks of important components . On top of the value creation and retribution and benefit sharing from the value created by recognition arrow are the â?? informal â?쳌 contributions made industrial development and commercialization . However , collectively and through generations by peasants and a wider definition of bioprospecting , such as the one used indigenous peoples that we are only beginning to fully below in describing the activities of an indigenous organi - recognize . Below the arrow are the contributions made zation in Oaxaca , is useful in leveling the ground because it by â?? formal â?쳌 institutions , which are commonly recognized recognizes the contribution of less intense biotechnological through State support or even by granting intellectual activities to value creation . property rights to guarantee a return of the investment in In general , the principal parties in ï쳌¡ ï쳌¢ ï쳌³ are the owners innovation . This inequality between forms of innovation of the biological resource ( the State and the landowners , that have been valued since the industrial revolution and be they private or collective ) , those intending to access the contributions , both past and present , that we are just be - the resource for technological development ( researchers , ginning to recognize is one of reason that ï쳌¡ ï쳌¢ ï쳌³ institutional research centers , and private companies ) , and a number designs tend to be so complex . Leveling the playing field of third parties involved in the ï쳌¡ ï쳌¢ ï쳌³ activities ( in country among all stakeholders can be very difficult ; consequently , collaborators ) . These third parties may probe to have a short - term , nonmonetary benefits are very important when primary role in terms of technology transfer due to the future benefits are , in a sense , meaningless to rural soci - need to have a suitable recipient in order for the transfer to eties that are dealing with basic survival and subsistence occur ( G ï쳌¯ ï쳌¬ ï쳌¬ ï쳌© ï쳌® ï?? ï?? ï?? ï?? ) . Hence , the roles each of the parties Existence in public , private or Traditional Management collective lands knowledge Domestication Transformation Extraction Consumption ï?? Commercialization Systematic Packing Cultivation description Genetic Breeding engineering Figure ï?? . Recognizing and adding value . In the end , the value of a product in the market is a reflection of multiple processes that involve traditional or â?? informal â?쳌 innovation and labor ( above the arrow ) and â?? formal â?쳌 contributions to the value of the product ( below ) . ï?? ï?? ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : M ï쳌¥ ï쳌¸ ï쳌© ï쳌£ ï쳌¯ play changes significantly from case to case , but the basic and the transaction costs can be very high . The follow - issue to be addressed is that each transaction among them ing examples will show that Mexico is far from reaching must be known and fully understood by all parties and such a level of understanding and trust between sectors . must involve a full recognition of the contribution of each . Thus , as they were ten years ago , awareness raising and The knowledge , understanding , and trust that is needed capacity building are still at the top of the agenda in order to reach this level of communication between parties is to enhance the social and cultural environment for ï쳌¡ ï쳌¢ ï쳌³ not easy to achieve in a polarized political environment , projects in rural Mexico . Three Bioprospecting Projects in Mexico The following sections deal with three projects imple - of nucleic acids from biological samples obtained from lands owned by the Federation and located within Natural mented in Mexico during the nineties . They are not the Protected Areas â?쳌 . The major benefits shared were â?? tech - only ones that occurred , but they are by far the ones bet - nologies and know - how transfer related to the extraction ter documented and in which the authors had first - hand and cloning of ï쳌¤ ï쳌® ï쳌¡ â?쳌 , plus â?? equipment transfer , payment experience and information . Other experiences involve of fees , and payment of royalties on products patented and early attempts by Shaman Pharmaceuticals ( C ï쳌¡ ï쳌­ ï쳌¢ ï쳌¥ ï쳌² ï쳌² ï쳌¯ ï쳌³ sold by Diversa â?쳌 . While the royalties attracted most of ï?? ï?? ï?? ï?? ) , a company that evolved into Shaman Botanicals , the attention , the main dispositions of the bioprospecting and also an International Cooperative Biodiversity Group 23 agreement are shown in Table ï?? , which reveals the sym - ( ï쳌© ï쳌£ ï쳌¢ ï쳌§ ) related to arid zones and implemented through metry of the institutions involved regarding activities and coordinated activities in several Latin American countries 24 benefits shown in Table ï?? . The aim was to obtain micro - ( T ï쳌© ï쳌­ ï쳌­ ï쳌¥ ï쳌² ï쳌­ ï쳌¡ ï쳌® ï쳌® et al . ï?? ï?? ï?? ï?? ) . organisms and nucleic acids from samples from extreme Of the three cases selected , the first one , based on environments and to seek subcomponents of industrial ecological and evolutionary knowledge , excluded bio - interest ( P ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌¤ ï쳌© ï쳌³ ï?? ï?? ï?? ï?? ) . prospecting in socially owned land . It precipitated a It is worth noting that the relationship between ï쳌µ ï쳌® ï쳌¡ ï쳌­ â?? popular denunciation â?쳌 that was presented before the and Diversa in no way included the potential asymmetries Federal Attorney for the Protection of the Environment involved in agreements between indigenous communities ( ï쳌° ï쳌² ï쳌¯ ï쳌¦ ï쳌¥ ï쳌° ï쳌¡ ) and triggered a set of recommendations that and international organizations . Thus , the mutually agreed effectively suspended the bioprospecting activities . The terms were fully understood by both parties . Particularly , second one included indigenous territories in Northern the ï쳌© ï쳌¢ ï쳌´ was a suitable recipient of the negotiated technol - Oaxaca , but excluded traditional resources and knowledge . ogy transfer . An example of ï쳌© ï쳌¢ ï쳌´ â?? s existing capacities to This project was completed successfully . The third case involved plants and traditional knowledge in the complex region of the Chiapas Mayan Highlands . This project was Table ï?? . General aspects of the mutually agreed terms cancelled , proving that the basic issues surrounding bio - between the ï쳌© ï쳌¢ ï쳌´ of ï쳌µ ï쳌® ï쳌¡ ï쳌­ and Diversa prospecting have not been resolved in Mexico . ï쳌© ï쳌¢ ï쳌´ of ï쳌µ ï쳌® ï쳌¡ ï쳌­ Diversa UNAM - Diversa : Bioprospecting in Extreme Obligations Obtain the ï쳌° ï쳌© ï쳌£ from the Provide technical Environments owner of the land . assistance to establish a Brief Overview Mexican collection of wild Collect and provide samples . microorganisms and ï쳌¤ ï쳌® ï쳌¡ This was the first ï쳌¡ ï쳌¢ ï쳌³ project in Mexico that went through Ensure that monetary sequences . a legal administrative process ; it is rich in legal documen - benefits are deposited in the Provide equipment and Biodiversity Trust Fund , on tation and also underwent academic and press scrutiny . training to collect and behalf of the owner of the Therefore , it reflects the legal issues as well as the multiple process samples . land , and channeled to the conflicting views of different sectors on these matters . The National Protected Areas . Provide technology and project is also less complex than others in that it excludes â?? know - how . â?쳌 traditional knowledge and collecting was designed to be Pay fee for samples . made only on Federal Public Land , a fact that brought into Provide corresponding one legal entity , the roles of the landowner subject of ï쳌° ï쳌© ï쳌£ benefits depending on the 25 and of the authority granting the permits . activities developed by ï쳌µ ï쳌® ï쳌¡ ï쳌­ . Institutional Context Rights On October ï?? ï?? , ï?? ï?? ï?? ï?? , the Biotechnology Institute ( ï쳌© ï쳌¢ ï쳌´ ) of Receive technology and Intellectual property rights the National Autonomous University of Mexico ( ï쳌µ ï쳌® ï쳌¡ ï쳌­ ) â?? know - how â?쳌 , technical and property rights over and the United States - based Diversa Corporation Inc . assistance , fee for samples , the components depending ( Diversa ) signed a bioprospecting agreement whose monetary benefits , and ï쳌© ï쳌° ï쳌² s . on the innovation activities purpose was the â?? collection , isolation , and extraction developed . ï?? ï?? ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ produce useful drugs is the development of a product for On ï?? ï?? November ï?? ï?? ï?? ï?? , the Secretariat of Environment noncoagulation of blood derived from the saliva of the and Natural Resources ( ï쳌³ ï쳌¥ ï쳌­ ï쳌¡ ï쳌² ï쳌® ï쳌¡ ï쳌´ ) , through the National common bat ( Desmodus rotundus ) in a biotechnological Institute of Ecology ( ï쳌© ï쳌® ï쳌¥ ) , the National Commission for project with plenty of innovation and with clear industrial the Knowledge and Use of Biodiversity ( ï쳌£ ï쳌¯ ï쳌® ï쳌¡ ï쳌¢ ï쳌© ï쳌¯ ) , and applications ( A ï쳌¬ ï쳌¡ ï쳌§ ï?³ ï쳌® - C ï쳌¡ ï쳌® ï쳌¯ ï?? ï?? ï?? ï?? ) . ï쳌© ï쳌¢ ï쳌´ was basically ï쳌µ ï쳌® ï쳌¡ ï쳌­ , through ï쳌© ï쳌¢ ï쳌´ , signed a Collaboration Agreement to playing on a level field . Furthermore , a search in the facilitate the execution of ï쳌µ ï쳌® ï쳌¡ ï쳌­ â?? s obligations under the ï쳌µ ï쳌³ ï쳌° ï쳌´ ï쳌¯ internet database on patents shows that Diversa is bioprospecting agreement . The main dispositions of this the assignee of ï?? ï?? patents as of ï?? ï?? May ï?? ï?? ï?? ï?? , and a brief agreement were that : review of these patents shows that Diversaâ??s intellectual â?¢ ï쳌© ï쳌® ï쳌¥ would select the collection sites located within property policy involves inventions with clear industrial Federal Public Land and within the boundaries of applications . Both of these factors are important in evaluat - Federal Natural Protected Areas . ing this agreement between two strong biotechnological â?¢ ï쳌µ ï쳌® ï쳌¡ ï쳌­ would be responsible for ensuring that institutions , one private and one public . monetary benefits arising from the bioprospecting One of the objectives of collecting on public lands agreement would be deposited in ï쳌£ ï쳌¯ ï쳌® ï쳌¡ ï쳌¢ ï쳌© ï쳌¯ â?? s Trust inside natural protected areas was that this contract would 26 Fund for Biodiversity , according to the guidelines be carried out in a setting of clear property rights for the jointly issued by the ï쳌© ï쳌® ï쳌¥ and ï쳌£ ï쳌¯ ï쳌® ï쳌¡ ï쳌¢ ï쳌© ï쳌¯ . State . This contributed to the Mexican experience in nego - â?¢ To implement the above , ï쳌µ ï쳌® ï쳌¡ ï쳌­ would keep a re - tiating access agreements without the complexity inherent cord of collection sites , collected samples , materials in diffuse settings of property and traditional knowledge of indigenous peoples . transferred to Diversa , and the derived products . Table ï?? . ï쳌µ ï쳌® ï쳌¡ ï쳌­ - Diversa agreement : joint and separate activities , intellectual property , and benefit sharing . Diversa does not collect material in any of the four different scenarios recognized by the agreement . Scenario 1 2 3 4 Collection Collection Collection Identification ï쳌µ ï쳌® ï쳌¡ ï쳌­ Isolation Isolation Separate Extraction Extraction Identification Activities Isolation Identification Diversa Extraction Identification Identification Applying for patent Joint over the same component Technology transfer to Royalties over Owns any rights over : pursue its activities products â?? net sales - Sample materials ( ï?? . ï?? % and ï?? . ï?? % ) - Derived Sharingproducts ï쳌µ ï쳌® ï쳌¡ ï쳌­ - Sales revenues - Intellectual Separate Benefit property rights Owns any rights over : Diversa - Sample materials and - Intellectual Property property rights First to identify prevails Obligation to Jointnegotiate if patents derive from a proportional Intellectualshare the same component . over : Other party will have - Sample materials right to : - Derived products - a nonexclusive - Sales revenues free license ( Intellectual - grant scientific property rights ) research sublicenses ï?? ï?? ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : M ï쳌¥ ï쳌¸ ï쳌© ï쳌£ ï쳌¯ 28 submitted a â?? popular denunciation â?쳌 against ï쳌µ ï쳌® ï쳌¡ ï쳌­ , ï쳌© ï쳌® ï쳌¥ , â?¢ ï쳌© ï쳌® ï쳌¥ and ï쳌£ ï쳌¯ ï쳌® ï쳌¡ ï쳌¢ ï쳌© ï쳌¯ would take adequate measures and ï쳌£ ï쳌¯ ï쳌® ï쳌¡ ï쳌¢ ï쳌© ï쳌¯ , for activities derived from the agreement to ensure that income from this source would be ( ï쳌° ï쳌² ï쳌¯ ï쳌¦ ï쳌¥ ï쳌° ï쳌¡ ï?? ï?? ï?? ï?? ) . Figure ï?? describes the parties to the used in the same Natural Protected Areas where controversy and gives an overview of the project . the materials had been collected . The â?? popular denunciation â?쳌 sought that the compe - Social Controversy tent authority , ï쳌° ï쳌² ï쳌¯ ï쳌¦ ï쳌¥ ï쳌° ï쳌¡ , should declare the nullity of the This bioprospecting project was seeing as a capacity - agreement and should also declare a general moratorium building experience to establish minimums for this type of on any bioprospecting activities in the country , based on contract . Press coverage showed that some saw this con - the following arguments : tract as a genetic resources â?? sale â?쳌 and failed to recognize â?¢ Genetic resources rest within the sovereignty of the value of the agreement as an important â?? know - how â?쳌 the Mexican State ; therefore ï쳌µ ï쳌® ï쳌¡ ï쳌­ cannot carry transfer between parties with similar scientific and techni - out acts of disposition of such resources . cal capabilities . On ï?? ï?? September ï?? ï?? ï?? ï?? , in La Jornada , a â?¢ Collecting would take place in Federal Land , and Mexico City newspaper , Alberto Székely and Alejandro the bioprospecting agreement did not take into ac - Nadal each wrote articles about the ï쳌µ ï쳌® ï쳌¡ ï쳌­ / Diversa project . count the Federationâ??s interests since it was not a While Székelyâ??s article ( â?? First effective effort to stop the party to the agreement . plundering of the genetic resources â?쳌 ) supported the project , â?¢ The collection was done in Natural ProtectedAreas Nadalâ??s article ( â?? The plundering of genetic resources â?쳌 ) subject to several property regimens , social or argued that the project had several legal and conceptual private , and the ï쳌° ï쳌© ï쳌£ of all right holders had not problems . If both of these authors are reasonable analysts , been obtained . why do they have totally opposite positions in this mat - â?¢ Benefit sharing was not equal due to the insignifi - ter ? The answer probably lies in the fact that multiple as - cant monetary fees . sumptions are being made by each of them . For example , Székely values the â?? know - how â?쳌 transfer , while Nadal â?¢ Some authorizations were issued for scientific pur - disregards it and even calls it â?? a mask â?쳌 . poses ; therefore , some activities could have been The main arguments in the press against the agreement done without authorization for biotechnological ran as follows : legal gaps must be attended to before any purposes . agreement is signed ; the agreement infringed national leg - â?¢ On the date of signature there was no proof of the islation , as well as the ï쳌£ ï쳌¢ ï쳌¤ ; ï쳌µ ï쳌® ï쳌¡ ï쳌­ had no rights over the ï쳌° ï쳌© ï쳌£ by the owner of the land . genetic material to be transferred to Diversa ; the benefits After a thorough review of the documents and facts , shared were ludicrous , and the contractual obligation to on ï?? ï?? November ï?? ï?? ï?? ï?? , ï쳌° ï쳌² ï쳌¯ ï쳌¦ ï쳌¥ ï쳌° ï쳌¡ issued recommendation share benefits was ambiguous and difficult to enforce . ï?? ï?? / ï?? ï?? ï?? ï?? on Access to Genetic Resources , in which it Another of the main opposing arguments stated that reasoned that it did not have the authority to declare the industrial property legislation excluded discoveries of agreement void . Further reasoning for the ï쳌° ï쳌² ï쳌¯ ï쳌¦ ï쳌¥ ï쳌° ï쳌¡ deci - natural phenomena , such as the discovery of the informa - sion is described in Table ï?? . tion merely hidden in genetic material , from patent pro - tection . Thus , all of the agreementâ??s clauses regarding the Current Situation possibility of obtaining patents were void . This argument As a consequence of this line of reasoning , ï쳌° ï쳌² ï쳌¯ ï쳌¦ ï쳌¥ ï쳌° ï쳌¡ recom - is important because it shows the perception that patents mended to the issuing authority ( ï쳌© ï쳌® ï쳌¥ ) that it should take on discoveries are being granted , and although they are the necessary measures to ensure that Diversa requested not the general rule , they undermine the very grounds of the adequate authorizations , that if so determined , the bioprospecting agreements in which genetic resource value president of ï쳌© ï쳌® ï쳌¥ issue the ï쳌° ï쳌© ï쳌£ separately from the autho - is recognized and innovation is protected . rization . Finally , it recommended that a wide public con - As a result of the ï쳌µ ï쳌® ï쳌¡ ï쳌­ - Diversa controversy in sultation should be undertaken regarding access to genetic Mexico , some provisions of international agreements , resources . As a result of the above recommendations and such as Article ï?? ï?? . ï?? . b of the Agreement on Trade Related of the uncertainties surrounding access conditions , all Intellectual Property Rights ( ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ ) which recognizes pat - bioprospecting activities were stopped , but collaboration ents on microorganisms , were brought into the public arena between the two institutions continued in capacity build - as a vehicle for protesting the international expropriation of ing , training and technology transfer . Since the contract genetic resources . Thus , a long - postponed debate started . was not declared void , the ï쳌¡ ï쳌¢ ï쳌³ agreement finally expired Despite the legal and technical inaccuracies and inconsis - on ï?? ï?? October ï?? ï?? ï?? ï?? . tencies found in its coverage , the press did reflect social Mexico had no prior experience in negotiating a con - concerns that must be fully considered to create legislation tract with so many advantages in â?? know - how â?쳌 transfer . that has legitimacy . If even these forms of benefit distribution are regarded as Press scrutiny raised doubts regarding the legality lacking value by those objecting to bioprospecting , the of the ï쳌µ ï쳌® ï쳌¡ ï쳌­ - Diversa agreement , and on ï?? June ï?? ï?? ï?? ï?? a road to legitimate bioprospecting in Mexico will still be 27 group of individuals and nongovernmental organizations a long one . ï?? ï?? ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ indigenous president that Mexico has had in its national UZACHI - Sandoz : A Bioprospecting history , was born in this region . Progressive Chinantec Experience in Indigenous Territories and Zapotec minds have led these communities in sev - without Providing Traditional Knowledge eral social movements throughout their history . In recent times they have claimed legal rights to manage their own For the purpose of this section we will use â?? bioprospecting â?쳌 forests . During the ï?? ï?? ï?? ï?? s they filed a lawsuit against the in a broad sense as in â?? the process of developing new uses Minister of Agriculture and the President and recovered for living organisms or their derivatives â?쳌 and not only for forest management and use rights that were previously using genetic resources ( C ï쳌¨ ï쳌¡ ï쳌° ï쳌¥ ï쳌¬ ï쳌¡ ï?? ï?? ï?? ï?? ) . Bioprospecting under concession to a decentralized government paper also includes the learning of new processing techniques or 29 company . Since then sawn wood has become their main uses , or more sophisticated biotechnologies , including source of income . fermentations and plant tissue culture or genetic manipula - ï쳌µ ï쳌º ï쳌¡ ï쳌£ ï쳌¨ ï쳌© has developed several initiatives to protect tion techniques . â?? their natural endowment â?쳌 and to develop their customary ï쳌µ ï쳌º ï쳌¡ ï쳌£ ï쳌¨ ï쳌© is the Spanish acronym for â?? Zapotec and stewardship institutions , using updated technologies when Chinantec Communities Union â?쳌 . It includes a Chinantec possible . They developed the first computerized forest pro - community of three settlements with ï?? , ï?? ï?? ï?? inhabitants duction control systems in the area , started a microbiology ( Comaltepec , La Esperanza , and Soyolapan ) and three laboratory , and were the first indigenous organization in Zapotec communities ( Xiacuí , Capulalpam , and Trinidad ) Oaxaca connected to the Internet . Recently , they set up with a population of ï?? , ï?? ï?? ï?? . The area is recognized for its their own plant tissue culture and ï쳌¤ ï쳌® ï쳌¡ analysis facilities . world - level biological importance , an example being the These processes were fostered by their traditional govern - presence of Papilio esperanza , a microendemic swallow - ing bodies . Their view is that the natural endowment within tail butterfly species named after the community mentioned their territories is to be responsibly used and developed to above ( T ï쳌¹ ï쳌¬ ï쳌¥ ï쳌² et al . ï?? ï?? ï?? ï?? ) . These and other Zapotec com - improve their living standards and to assure the well being munities were the cradle of nineteenth century progressive and liberal thinking . Benito Juarez , the only self - conscious of their children and grandchildren . Commercialization Natural Protected Areas Innovation and % $ product development Trust fund Authorizations Details in Table 2 and text Diversa ï쳌µ ï쳌® ï쳌¡ ï쳌­ ï쳌© ï쳌¢ ï쳌´ ï쳌£ ï쳌¯ ï쳌® ï쳌¡ ï쳌¢ ï쳌© ï쳌¯ î?? î?? î?? Agreement Collaboration agreement Demands Objects to the nullification collaboration agreement Recommendations of agreement as adequate ï쳌° ï쳌© ï쳌£ â?? Popular denunciation â?쳌 filed with ï쳌° ï쳌² ï쳌¯ ï쳌¦ ï쳌¥ ï쳌° ï쳌¡ ï쳌° ï쳌² ï쳌¯ ï쳌¦ ï쳌¥ ï쳌° ï쳌¡ Figure ï?? . Overview of the ï쳌µ ï쳌® ï쳌¡ ï쳌­ - Diversa controversy . The bioprospecting agreement signed between Diversa and the ï쳌© ï쳌¢ ï쳌´ of ï쳌µ ï쳌® ï쳌¡ ï쳌­ was followed by a Collaboration Agreement between ï쳌© ï쳌® ï쳌¥ , ï쳌£ ï쳌¯ ï쳌® ï쳌¡ ï쳌¢ ï쳌© ï쳌¯ , and ï쳌µ ï쳌® ï쳌¡ ï쳌­ . After months of press scrutiny , a â?? Popular Denunciation â?쳌 was submitted to ï쳌° ï쳌² ï쳌¯ ï쳌¦ ï쳌¥ ï쳌° ï쳌¡ with the demands indicated . The process concluded with a set of recommendations to ï쳌© ï쳌® ï쳌¥ . ï?? ï?? ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : M ï쳌¥ ï쳌¸ ï쳌© ï쳌£ ï쳌¯ The prevalence of traditional governance structures took place at the same time as the ï쳌£ ï쳌¢ ï쳌¤ was discussed , this contract was one of the first in the world to test and set and a strong sense of the territory do not mean physical in practice the main principles of this new international or cultural isolation in this case . Apparently , the use of framework . modern technologies is not seen as a threat to their cus - It is very important to underline that the signatories tomary management systems , but rather as tools to control from the biological resources supply side were the indig - their resources under traditional governance and steward - enous communities . A Sandoz - Pharma high - level officer ship structures . ï쳌µ ï쳌º ï쳌¡ ï쳌£ ï쳌¨ ï쳌© had fully appropriated its territory and the president of the indigenous organization signed the before bioprospecting was even considered . This approach contract ( see Figure ï?? for an overview of the agreement ) . was , in a sense , wise management of its resources , as long In recent times , this component of ï쳌µ ï쳌º ï쳌¡ ï쳌£ ï쳌¨ ï쳌© â?? s activities has as ï쳌µ ï쳌º ï쳌¡ ï쳌£ ï쳌¨ ï쳌© had the cultural capacity to control them and to received public attention , so we will address the issue , but it get tangible benefits from them . For instance , in ï?? ï?? ï?? ï?? they must be kept in mind that the ï쳌µ ï쳌º ï쳌¡ ï쳌£ ï쳌¨ ï쳌© - Sandoz contract was contacted matzutake mushroom brokers to benefit from a only part of a more comprehensive strategy of indigenous valuable market . Matzutake , meaning â?? pine mushroom â?쳌 communities to control their resources , develop new uses in Japanese , is an interesting delicatessen item . One fresh for them , and expand their own knowledge and resource kilogram is worth about ï?? ï?? ï?? to ï?? ï?? ï쳌µ ï쳌³ ï쳌¤ . Brokers were transformation capacities . given the following conditions : buyers would have no ac - cess to ï쳌µ ï쳌º ï쳌¡ ï쳌£ ï쳌¨ ï쳌© â?? s forests ; they would go to a community Institutional Context delivery point and purchase from community - authorized An interesting feature of the property system in collectors ; and they would pay them a previously publicly Mexico is the right of rural and indigenous communities agreed price and pay an extra ï?? ï?? % fee to the community recognized by the Constitution to own land collectively . for control and protection activities . As matzutake had However , communities have struggled to exercise this no previous use for these communities , these contracts property right . For their bioprospecting activities , they enabled them to benefit from a â?? new â?쳌 biological resource . claimed in a sense , this full or broad property right . This is a simple but effective way to bioprospect , develop - In fact , environmental law was the only legislation ing a component of biodiversity into a biological resource available to regulate rights over biological resources . It and its derived products . After this experience , ï쳌µ ï쳌º ï쳌¡ ï쳌£ ï쳌¨ ï쳌© â?? s used basically the same framework : the landowner has bioprospecting activities expanded . In ï?? ï?? ï?? ï?? , they started the right to develop the biological resources , as long as their own studies on local edible mushrooms and on their he / she does not threaten biodiversity , vegetation or the soil . traditional knowledge , which was vanishing . One year This legal framework made it possible for an indigenous later , they started to train their own personnel in ecology organization to sign a legally binding contract with an and plant tissue culture . international firm . With its â?? ethno - oriented sustainable development â?쳌 Building on experience , ï쳌µ ï쳌º ï쳌¡ ï쳌£ ï쳌¨ ï쳌© negotiated with approach , ï쳌µ ï쳌º ï쳌¡ ï쳌£ ï쳌¨ ï쳌© tried to contact pharmaceutical indus - Sandoz carefully considering the following hierarchi - tries to develop other biological resources . Their previous cally structured items : matzutake success gave them confidence to explore a new â?¢ Minimize potential risks to their common natural area . After considering several options , and after a three - endowment . Under no circumstance would access year negotiating process ( ï?? ï?? ï?? ï?? â?? ï?? ï?? ï?? ï?? ) , they finally signed to communal lands be granted to Sandoz collec - a three - year ( ï?? ï?? ï?? ï?? â?? ï?? ï?? ï?? ï?? ) contract with the Switzerland - tors , and no herbal traditional knowledge would be 30 based Sandoz - Pharma . A local nongovernmental orga - provided under any agreement . nization , Estudios Rurales y Asesoría Campesina ( ï쳌¥ ï쳌² ï쳌¡ ) , assisted them in the negotiation process , mainly as transla - â?¢ Maximize their own ability to manage biodiversity - tors and as technical advisors . As the negotiating process related transactions and to capture as much as pos - Table ï?? . ï쳌° ï쳌² ï쳌¯ ï쳌¦ ï쳌¥ ï쳌° ï쳌¡ â?? s analysis of the ï쳌µ ï쳌® ï쳌¡ ï쳌­ - Diversa agreement regarding the authorization , the collecting role , the ï쳌° ï쳌© ï쳌£ , and the benefit - sharing issue Authorization Collecting role ï쳌° ï쳌© ï쳌£ Benefit sharing Diversa must obtain the The intermediary role of the The ï쳌° ï쳌© ï쳌£ must be explicit and This could only be evalu - collector must be exercised ated once the joint guide - authorization because it has cannot be confused with the through a previous and lines for making deposits the biotechnology purpose authorization , nor with the 31 explicit mandate of the were clearly defined . ( not the ï쳌© ï쳌¢ ï쳌´ ) . collaboration agreement . Federation . It must be included in the Although they were based bioprospecting agreement . on Article ï?? ï?? ï쳌¢ ï쳌© ï쳌³ , they Thus , the bioprospecting were specifically issued agreement was not the final â?? for scientific purposes â?쳌 . agreement , but merely part Thus , no authorizations for bioprospecting existed . of the negotiations . ï?? ï?? ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ sible the benefits from their biological resources . to their resources and products . This goal is consistent with the priorities outlined above , and it made the issues â?¢ Maximize collective benefits in the medium of infrastructure and social capital building more important term . to the negotiations than the royalties issue . This contrasts â?¢ Maximize short - term benefits . with most ï쳌¡ ï쳌¢ ï쳌³ initiatives , where royalties play a central role in the contractual design . The institutional framework to negotiate the agreement within ï쳌µ ï쳌º ï쳌¡ ï쳌£ ï쳌¨ ï쳌© was a nested scheme where each com - Another negotiating goal was to retain any right of ac - munity discussed the issues related to their biological cess to the community lands . Thus , access for Sandoz was resources in a general assembly . Then , the communities only indirect , and ï쳌µ ï쳌º ï쳌¡ ï쳌£ ï쳌¨ ï쳌© offered value - added products . gathered and let the organization know their concerns and This approach gave them room to receive benefits other interests through three delegates . The delegates assembly than royalties and enable them to demand infrastructure set their priorities as explained above , and a negotiating investments , training , collection fees , laboratory work , team was then formed to contact Sandoz . This multi - lay - and collaboration fees . Of course , a share of the benefits ered process included technical and information support in case a new product would be developed and marketed provided by ï쳌¥ ï쳌² ï쳌¡ , which in turn had a formal agreement was also negotiated . to collaborate with ï쳌µ ï쳌º ï쳌¡ ï쳌£ ï쳌¨ ï쳌© . From the Sandoz perspective , the main interest was not ï쳌¥ ï쳌² ï쳌¡ also served as a communication path between the pharmacological but a more strategic one . They wanted ï쳌µ ï쳌º ï쳌¡ ï쳌£ ï쳌¨ ï쳌© negotiating team and Sandoz , translating messages to understand how they could engage in long - term bio - to Switzerland and back to the communities . This transla - prospecting activities . They were also exploring the tion function was not merely changing words from one potential risks and benefits of the ï쳌£ ï쳌¢ ï쳌¤ â?? s new legal frame - language to other , but making the messages understandable work . In contrast with other bioprospecting firms , Sandoz to both Sandoz officers and the Zapotec and Chinantec is not a natural products business and is not interested communities . To do this work , ï쳌¥ ï쳌² ï쳌¡ had financial support in traditional knowledge . Their approach is not to find from private foundations and was not a contracting party . It â?? active principles â?쳌 in medicinal herbs and convert them had no benefit from the contract besides previously agreed into drugs . Most of their products come from chemical upon honoraria . synthesis and their expertise relies in combinatory chem - istry . However they had observed competitors , such as Access Merck or Schering , investing in bioprospecting , and their One of ï쳌µ ï쳌º ï쳌¡ ï쳌£ ï쳌¨ ï쳌© â?? s goals for the negotiation was to develop as far as possible the communities â?? capacities to add value administration wanted to have first - hand understanding $ ï쳌µ ï쳌º ï쳌¡ ï쳌£ ï쳌¨ ï쳌© Communities revolving funds $ ï쳌µ ï쳌º ï쳌¡ ï쳌£ ï쳌¨ ï쳌© â?? s laboratories fund $ Operational plan Endowment to trust fund in case and coordination successful molecules found Community - owned , Payments protected lands and forests $ Litter samples ï쳌µ ï쳌º ï쳌¡ ï쳌£ ï쳌¨ ï쳌© â?? s microbiology lab Isolation and characterization Sandoz Administrative Unit Sandoz Research Unit Figure ï?? . Overview of ï쳌µ ï쳌º ï쳌¡ ï쳌£ ï쳌¨ ï쳌© - Sandoz Agreement . The private party in the agreement received isolated and character - ized samples and did not have access to the territory . On the other hand , the organization and its communities received upfront short - term benefits in the form of capacity building and direct financing of prospecting activities . ï?? ï?? ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : M ï쳌¥ ï쳌¸ ï쳌© ï쳌£ ï쳌¯ of the opportunities and risks involved in this emerging system to use these funds to finance small projects . In this area . The main interest for Sandoz in bioprospecting was way each communityâ??s financial assets increased a little , that if the chemists in Switzerland had hints from ecolo - and ï쳌µ ï쳌º ï쳌¡ ï쳌£ ï쳌¨ ï쳌© increased its capacities . gists collaborating with in - field organizations in tropical Although the contract was basically a research endeav - areas these chemists might find strategic paths for their or , in which Sandoz tried to understand how bioprospect - combinatory chemistry capacities . ing could help its own pharmaceutical research , there is a On the other hand , for a high - tech industry like Sandoz , chance that some compounds , within the thousands that the most interesting taxonomic groups are not plants or ani - the project yielded , may be interesting and lead to the mals , where knowledge has accumulated for centuries and development of novel pharmaceutical products . In that the most interesting compounds are already in the market , case , ï쳌µ ï쳌º ï쳌¡ ï쳌£ ï쳌¨ ï쳌© would receive a previously agreed - upon but instead : the microscopic world , which only began to be fixed royalty . The amount negotiated was an endowment explored at the end of nineteenth century and which is one big enough to finance their technical staff in perpetuity . It of the most promising field for future discoveries . will take years to see if any compound or molecule will Under the agreement , ï쳌µ ï쳌º ï쳌¡ ï쳌£ ï쳌¨ ï쳌© took care of all field yield such a result , but at present , ï쳌µ ï쳌º ï쳌¡ ï쳌£ ï쳌¨ ï쳌© feels that the operations , under mutually agreed standards and under benefits it received were fair . precise and stringent field and laboratory protocols . This Social Controversies ensured useful results for Sandoz at their chemistry labs Social objections to this project have to be placed into in Switzerland . ï쳌µ ï쳌º ï쳌¡ ï쳌£ ï쳌¨ ï쳌© sent their people to Basel to context at the local , regional , and national / international be trained on the protocols , and then started collecting levels . Locally , the project had wide support from ï쳌µ ï쳌º ï쳌¡ ï쳌£ ï쳌¨ ï쳌© â?? s forest debris samples which they processed in their lab , communities because they proposed it . Their basic concerns isolating and characterizing microscopic mushrooms and were met : control over access to their lands and resources actinomycetes , selecting those that seemed to be involved and benefits from their biological resources . However , con - in ecological relationships such as commensalism , sym - troversies did arise . There was a tendency to give more jobs biosis , or parasitism , filing strains into their collection , and to youth from the south ( Zapotec ) area , and the Chinantec mailing duplicates to Basel for chemical analysis without people asked for a more equitable job policy . Unfortunately , disclosing the biological identity of the samples . the project did not expand enough to provide more employ - Benefit Sharing ment . Two communities had problems agreeing on how to From the start it was evident that the asymmetry between manage the community fund and set the priorities for using Sandoz and ï쳌µ ï쳌º ï쳌¡ ï쳌£ ï쳌¨ ï쳌© was huge . Hence , the scheme of a it , which delayed the transfer of funds to one community partnership based on a percentage of net earnings as for a couple of months , and to the second one for a couple royalties seemed very unlikely to benefit ï쳌µ ï쳌º ï쳌¡ ï쳌£ ï쳌¨ ï쳌© , whose of years . This situation provoked tensions , but finally all strategy was not to include sensitive information , such as community funds were transferred . traditional knowledge , in the agreement and to take , as At the regional level , the project had little or no at - soon as possible , their benefits : increased human , social , tention despite efforts made . Two regional information and physical capital . meetings had a very weak response from neighboring Hence they ensured that most benefits would material - communities , and ï쳌µ ï쳌º ï쳌¡ ï쳌£ ï쳌¨ ï쳌© also asked the local radio ize in the short term . This proved wise , because near the station to broadcast information about the project . The end of the contract Sandoz merged with Ciba , the lead people in charge said the issue had insufficient interest research laboratory in Basel was restructured , and the to expend airtime on it . Much later , two years after the new administration did not give high priority to long - contract expired and Sandoz disappeared as such , some term chemical innovation processes . This decision has people at the radio station realized the importance of the unpredictable consequences to the competitiveness of ï쳌µ ï쳌º ï쳌¡ ï쳌£ ï쳌¨ ï쳌© - Sandoz project . Indigenous communities directly Novartis - Pharma , but in any case ï쳌µ ï쳌º ï쳌¡ ï쳌£ ï쳌¨ ï쳌© accomplished prospecting on their own lands and receiving Swiss Francs its main short - term objectives . to their bank account now seemed unusual and interesting . This case is also peculiar in terms of ï쳌¡ ï쳌¢ ï쳌³ because Unfortunately , the door for more bioprospecting activities they did not need a long chain of intermediaries . The in - was already closed , at least for the moment , because ne - frastructure was owned by Sandoz during the three - year gotiations with Switzerland were suspended until a clear contract and then passed to ï쳌µ ï쳌º ï쳌¡ ï쳌£ ï쳌¨ ï쳌© ownership . ï쳌µ ï쳌º ï쳌¡ ï쳌£ ï쳌¨ ï쳌© legal access framework was available in Mexico . has since used the lab for its own activities . Payments for This situation upset the people at the radio station , who sampling and laboratory jobs were deposited directly into then used their airtime to discuss ï쳌µ ï쳌º ï쳌¡ ï쳌£ ï쳌¨ ï쳌© â?? s selfish attitude . ï쳌µ ï쳌º ï쳌¡ ï쳌£ ï쳌¨ ï쳌© â?? s account , and were first used to cover operational They also charged ï쳌µ ï쳌º ï쳌¡ ï쳌£ ï쳌¨ ï쳌© with â?? biopiracy â?쳌 , because , as expenses . Three years after the contract expired , the earn - they understood the contract , ï쳌µ ï쳌º ï쳌¡ ï쳌£ ï쳌¨ ï쳌© gave Sandoz seeds , ings that remained were used to finance further prospecting herbs , and traditional knowledge that was not their prop - activities . Payments to communities were transferred from erty , but a natural and cultural endowment that belonged ï쳌µ ï쳌º ï쳌¡ ï쳌£ ï쳌¨ ï쳌© â?? s bank account to each communityâ??s account on to the Zapotec and Chinantec peoples . However , these a revolving basis after they had their own administrative components had been explicitly excluded from the very ï?? ï?? ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ beginning and for the same reasons . edible mushrooms found in its communities and can de - velop the technological package to cultivate them . Again , At the national and international level , the claims the main approach is not to profit from supplying biomass , from the local radio were magnified through the newspa - but from technical services . per â?? La Jornada â?쳌 with aid from the Rural Advancement Another bioprospecting area being developed by ï쳌µ ï쳌º ï쳌¡ - International Foundation ( ï쳌² ï쳌¡ ï쳌¦ ï쳌© ) ( known today as the ï쳌£ ï쳌¨ ï쳌© is tissue culture for the reproduction of ornamental action group on Erosion Technology and Concentration plants with two purposes : The first is to commercialize ( ï쳌¥ ï쳌´ ï쳌£ ) ) . ï쳌² ï쳌¡ ï쳌¦ ï쳌© posted the â?? biopiracy â?쳌 accusation on the orchids , cycads , ferns , and bromeliads , internalizing in Internet and circulated it via many international email the price the tissue culture costs and a fee to support the networks . These claims were stopped by ï쳌µ ï쳌º ï쳌¡ ï쳌£ ï쳌¨ ï쳌© leaders , conservation areas . Hence , plants obtained through â?? soft â?쳌 who asked representatives of neighboring communities biotechnologies may help pay the costs of stewardship to clarify things . ï쳌µ ï쳌º ï쳌¡ ï쳌£ ï쳌¨ ï쳌© publicly showed that they were of mother plants and their natural habitat . Technical as - using their legitimate rights over their territories , and that sistance contracts with other communities could be the they did not commit to the project any plant , animal , or second purpose . In the long run , this activity may support any traditional knowledge . Regarding other communities â?? the development of a market for sustainably produced interest in benefiting from bioprospecting , ï쳌µ ï쳌º ï쳌¡ ï쳌£ ï쳌¨ ï쳌© let them ornamental plants and a network of indigenous com - know that they hoped more communities would benefit munities producing and marketing these â?? exotic â?쳌 plants from their biological resources , and that they would be internationally . Regarding plant variety protection the willing to develop a new bioprospecting contract along visualized strategy could be to publish the characteristics with other communities whenever that might be possible . of the varieties so the materials may be regarded as â?? previ - In response , two dozen community representatives from ous art â?쳌 and not subject to patent or plant variety claims . the region signed a letter of support of ï쳌µ ï쳌º ï쳌¡ ï쳌£ ï쳌¨ ï쳌© and pub - This could help prevent biopiracy . The benefits from these lished it in the state newspapers . They did not have the activities will come directly from marketing plants and not money ( ï?? ï?? , ï?? ï?? ï?? ï쳌µ ï쳌³ ï쳌¤ ) to publish it in a national journal so it from proprietary claims over germplasm or the royalties was never known at the national or international levels . produced by such rights . An interesting fact is that indigenous communities in Among many other lessons , this experience shows Oaxacaâ??s Sierra Norte are deeply interested in gaining that bioprospecting agreements can reach legitimacy if control over their biological resources and in obtaining tan - they are a part of a much wider process of social and cul - gible benefits from them on their tables and their pockets . tural appropriation of territories and resources . Thus , full Bioprospecting projects in their broadest sense , including implementation of ï쳌£ ï쳌¢ ï쳌¤ objectives at the local and national â?? soft â?쳌 biotechnology , are only one of several ways in which level is a precondition for the development of locally and to achieve these aims . regionally legitimate ï쳌¡ ï쳌¢ ï쳌³ projects in Mexico . Current Situation The Maya International Cooperative ï쳌µ ï쳌º ï쳌¡ ï쳌£ ï쳌¨ ï쳌© â?? s international activities are on stand - by because there is legal confusion regarding the current ï쳌¡ ï쳌¢ ï쳌³ legal Biodiversity Group ( ECOSUR - University framework in Mexico . Under current circumstances , both of Georgia - Molecular Nature Limited ) : the industry and the communities â?? organization cannot Bioprospecting Resources and their commit to long - term ï쳌¡ ï쳌¢ ï쳌³ contracts . However , the interest Associated Traditional Knowledge of local communities in bioprospecting is high , and they would be willing to negotiate a new contract under the ba - Brief Overview sic principles outlined above and within a comprehensive The Maya International Cooperative Biodiversity Group regulatory framework . was one of the ï쳌© ï쳌£ ï쳌¢ ï쳌§ s approved in ï?? ï?? ï?? ï?? . The Maya ï쳌© ï쳌£ ï쳌¢ ï쳌§ On the â?? internal front â?쳌 ï쳌µ ï쳌º ï쳌¡ ï쳌£ ï쳌¨ ï쳌© is still developing its was created on the premise that biological resources and biological resources potential . It has become the main traditional knowledge can be effective motivators for com - supplier of mushroom â?? seeds â?쳌 to other communities in munity development and resource conservation through the the region , concentrating on the saprophytes Pleurotus development of natural products such as phytomedicines ostreatus and Lentinus edodes . ï쳌µ ï쳌º ï쳌¡ ï쳌£ ï쳌¨ ï쳌© does not seek to and agroecological programs , as well as through the de - profit from the mushrooms themselves , but from the tech - velopment of patentable pharmaceuticals ( R ï쳌¯ ï쳌³ ï쳌¥ ï쳌® ï쳌´ ï쳌¨ ï쳌¡ ï쳌¬ et nical advice they can give to other communities to set up al . ï?? ï?? ï?? ï?? ) . The participating institutions in this ï쳌© ï쳌£ ï쳌¢ ï쳌§ were their own rustic mushroom production units . This initiative El Colegio de la Frontera Sur ( î?? î?? î?¡ î?¬ î?° î?« ) in Mexico , the has helped recover mushroom traditional knowledge that University of Georgia ( ï쳌µ ï쳌§ ï쳌¡ ) in the ï쳌µ ï쳌³ ï쳌¡ , and a small United was very fragmented and had nearly vanished ; this reap - Kingdom based biotechnology company named Molecular propriation process is helping mushrooms to reappear on Nature Limited ( ï쳌­ ï쳌® ï쳌¬ ) that was funded in ï?? ï?? ï?? ï?? . The study Oaxacan tables . area for the project was the Chiapas highlands , in southeast In the near future , ï쳌µ ï쳌º ï쳌¡ ï쳌£ ï쳌¨ ï쳌© may expand its local bio - Mexico , a region with political conflict , extreme poverty , prospecting activities aimed at regional consumption and and cultural erosion . For an overview of the agreement , self - sufficiency . The organization has collected the main see Figure ï?? . ï?? ï?? ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : M ï쳌¥ ï쳌¸ ï쳌© ï쳌£ ï쳌¯ In terms of access to genetic resources , the Maya ï쳌© ï쳌£ ï쳌¢ ï쳌§ the project in October ï?? ï?? ï?? ï?? . Thus , this section outlines the undertook an important effort to obtain ï쳌° ï쳌© ï쳌£ from the com - proposal and the process , but does not describe a finished munities , both in terms of time and resources dedicated to and implemented bioprospecting project . the task . The benefit - sharing provisions in the Maya ï쳌© ï쳌£ ï쳌¢ ï쳌§ Institutional Context contained some of the most comprehensive packages , in - The traditional medicine of the Chiapas â?? highlands is un - cluding co - ownership of patents , technology transfer , and usual in that the communities do not systematically culti - dissemination of â?? science - validated â?쳌 traditional knowl - vate medicinal plants . The Tzotzil and Tzeltal typically use edge ( B ï쳌¥ ï쳌² ï쳌¬ ï쳌© ï쳌® et al . ï?? ï?? ï?? ï?? ) . Unfortunately , these were fresh plants to produce remedies and do not use cultivated not enough to give the project viability in the Chiapas â?? species dried or bought in local markets . Communities highlands . Early in its development , opposing regional obtain the most common plants at the sides of roads and organizations of traditional healers coupled with radical paths or in secondary forests , and , although some species organizations at the international level rendered the project politically infeasible , forcing the definitive shut down of are found in restricted habitats , the system appears to have Biological materials Bioassay results and validation of ï쳌´ ï쳌« Individual ï쳌µ ï쳌§ ï쳌¡ î?? î?? ï쳌¯ î?¬ î?° î?« Bar - coded samples Communities Medicinal plant gardens , documentation and dissemination of ï쳌´ ï쳌« , product Bioassay results , quality control , agroecological validation of ï쳌´ ï쳌« and pest control , and promotion of molecular structures validated remedies Representation Bar - coded samples Technical Economic assistance , benefits possible partnership ï쳌­ ï쳌® ï쳌¬ Community - owned enterprises â?? natural products â?쳌 Participation Promaya Filing for intellectual property protection Negotiation of license agreements All intellectual property is co - owned . Net revenue is shared equally ( î?? î?? î?¡ î?¬ î?° î?« , ï쳌µ ï쳌§ ï쳌¡ , ï쳌­ ï쳌® ï쳌¬ , Chiapas Fund ) . Funding for conservation ï?? ï?? % net revenue of biodiversity and License Payment from license promotion of ï쳌´ ï쳌« Chiapas â?? Highlands Fund Licensee Figure ï?? . Overview of Maya ï쳌© ï쳌£ ï쳌¢ ï쳌§ . The complexity of the institutional design is self evident from the figure . Although î?? î?? î?¡ î?¬ î?° î?« , ï쳌µ ï쳌§ ï쳌¡ , and ï쳌­ ï쳌® ï쳌¬ agreed on the terms of the collaboration , and on the side of the Mayan collaborators there was agreement with individual communities , second and third level social organizations ( such as ï쳌¯ ï쳌­ ï쳌© ï쳌¥ ï쳌£ ï쳌¨ and ï쳌£ ï쳌¯ ï쳌­ ï쳌° ï쳌© ï쳌´ ï쳌£ ï쳌¨ ) objected to the agreement . ï?? ï?? ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ worked well until recently , when population growth and its Short term â?¢ Assistance in developing medicinal plant gardens ecological impact affected the availability and distribution and information leaflets about medicinal plants in of some species . In addition , the poverty in which most of local languages ; the population of the region lives has created great pressure on their cultures and traditions , leading to cultural erosion â?¢ Production of documents and databases on tradi - and loss of knowledge . Preventing the irreversible loss of tional knowledge that , if desired by local communi - traditional knowledge is one of the greatest challenges for ties , could be used to defend traditional knowledge the region . The Maya ï쳌© ï쳌£ ï쳌¢ ï쳌§ was an attempt to advance in against misappropriations ; this area in the field of ethnomedicine and ethnobotanical â?¢ Generation of a sound biological and ethnobotani - knowledge . The Maya ï쳌© ï쳌£ ï쳌¢ ï쳌§ â?? s choice of Chiapas for the cal information base , including a dissemination project could be considered risky , but given the social strategy at the local level and among academic needs , it was definitely worthwhile . centers in Mexico , thus directing research efforts Poverty , culture , and indigenous rights are issues to the region and making them more efficient ; of great social and political relevance in contemporary â?¢ Work on agroecological experiments directed at Chiapas and Mexico . The Zapatista movement uprising exploring the potential of medicinal plants for the began in ï?? ï?? ï?? ï?? and after a decade no profound and peaceful control of disease in local crops , which if success - solution has been found . ful , could reduce the damage caused by disease and In terms of the academic context , this project had an by mitigation practices , since these technologies ideal platform , with more than three decades of work on would be freely available ; ethnobotanical knowledge by Drs . Brent and Eloise Berlin â?¢ Dissemination of traditional knowledge among the and with î?? î?? î?¡ î?¬ î?° î?« , a regional research center well equipped communities in the highlands through workshops and committed to make science one of the driving forces and other means ; towards sustainable development in the region . Many of Mid - term the communities where the project was promoted had done â?¢ Studies on the biological activity of traditional previous work with î?? î?? î?¡ î?¬ î?° î?« . remedies aimed at identifying the most active and Access effective and creating a constructive bridge between The Maya ï쳌© ï쳌£ ï쳌¢ ï쳌§ sought to respect the rights of the com - formal and traditional health systems , increasing munities over their plants and knowledge . To that end , the the interest of the former in the latter ; ï쳌° ï쳌© ï쳌£ of the communities was essential before collecting with â?¢ Evaluation of the technical and economic potential biotechnological development purposes could take place . of species as phytomedicines in national and in - All channels available were used to transmit the projectâ??s ternational markets , as well as assistance for small aims : leaflets in Mayan languages , meetings in community local cooperatives interested in the sustainable pro - assemblies , radio broadcasts , and plays . By â?? community â?쳌 , duction of these species and remedies ; the project meant the paraje , a sub - unit of agrarian com - Long term munities that traditionally maintained a high degree of in - â?¢ Assessment of chemical compounds found in plants dependence in their decisions . The high number of parajes with the potential to become commercial products , within agrarian communities has rendered them unable to with communities benefiting from a share in the net handle a number of issues relevant for communal life , but revenue obtained . In case a biotechnological prod - the paraje seemed like the right choice as the basic unit of uct was developed as part of the Maya ï쳌© ï쳌£ ï쳌¢ ï쳌§ ; and social involvement with the project . Eventually , to comply â?¢ Explicit agreements to split the net revenue with national legislation that does not recognize this legal equally among the partners ( î?? î?? î?¡ î?¬ î?° î?« , ï쳌µ ï쳌§ ï쳌¡ , ï쳌­ ï쳌® ï쳌¬ , unit , the permits would have to be revalidated before the and a Chiapas Highlands Development Fund ) . to general communal assembly , which in most cases respects guarantee that ï?? ï?? % of direct net revenue would be the decisions of the individual parajes . However , the politi - invested in the region , and both ï쳌µ ï쳌§ ï쳌¡ and î?? î?? î?¡ î?¬ î?° î?« cal turmoil generated by the project prevented its efforts commiting their share , an additional ï?? ï?? % , to eth - and the validation of the individual community decisions nobotanical research in the region . before the general assemblies did not take place . Benefit Sharing Moreover , with a view to safeguarding the rights of Equitable benefit sharing is one of the objectives of the communities , the Maya ï쳌© ï쳌£ ï쳌¢ ï쳌§ considered the creation of a ï쳌£ ï쳌¢ ï쳌¤ , and the Maya ï쳌© ï쳌£ ï쳌¢ ï쳌§ attempted to implement it fully . participation mechanism for the communities as partners Of particular importance was to provide short - term as in the project . Promaya was conceived as a social organi - well as long - term benefits , recognizing that communi - zation with representatives from the communities in the ties could not adjust to the timeframes typically found in Chiapas highlands to help them coordinate their participa - pharmaceutical research . Proposed benefits in different tion in the Maya ï쳌© ï쳌£ ï쳌¢ ï쳌§ . This organization would not only time frames included : participate in the Maya ï쳌© ï쳌£ ï쳌¢ ï쳌§ â?? s decisions , but would also ï?? ï?? ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : M ï쳌¥ ï쳌¸ ï쳌© ï쳌£ ï쳌¯ be co - owner of any intellectual property arising from the herbarium as well as the associated taxonomic work as part project , with the right to propose and veto proposed uses of the biodiversity survey . By May ï?? ï?? ï?? ï?? , the decision was and to negotiate licenses on the products of the project . taken to initiate plant collecting for scientific purposes and This aspect represents one of the most significant in - the trainees started work that summer . Since no bioassays novations of the Maya ï쳌© ï쳌£ ï쳌¢ ï쳌§ in comparison with other were involved and no extracts were to be derived from the bioprospecting projects . collected plants , this part of the work fell within what is commonly referred to as scientific research , which was Social Controversy already authorized by the government under the respon - 32 Representatives from the ï쳌© ï쳌£ ï쳌¢ ï쳌§ approached ï쳌¯ ï쳌­ ï쳌© ï쳌¥ ï쳌£ ï쳌¨ in sibility of the herbariumâ??s principal researcher . Also in January ï?? ï?? ï?? ï?? , before the response to the request for ap - May ï?? ï?? ï?? ï?? , an agreement on minimal principles regarding plications was submitted to the ï쳌µ ï쳌³ ï쳌¡ National Institutes Intellectual Property Rights was signed between î?? î?? î?¡ î?¬ î?° î?« , of Health , to assess their interest in participating . At that ï쳌µ ï쳌§ ï쳌¡ , and ï쳌­ ï쳌® ï쳌¬ . meeting , they showed little interest and expressed some Work on the legal framework of the project also con - opposition to the involvement of a private commercial tinued , including the design of Promaya as a fund and partner and to Dr . Berlin , as a leader of the group , with as an organization . ï쳌¯ ï쳌­ ï쳌© ï쳌¥ ï쳌£ ï쳌¨ was also invited to provide whom there was some pre - existing antagonism . This first comments and to be involved in Promaya , and a meeting encounter was intended to invite them to participate as one was set for mid - September with them . Unfortunately , the of many organizations in Chiapas . The ï쳌© ï쳌£ ï쳌¢ ï쳌§ believed that meeting never took place , since ï쳌¯ ï쳌­ ï쳌© ï쳌¥ ï쳌£ ï쳌¨ â?? s first press re - 33 ï쳌¯ ï쳌­ ï쳌© ï쳌¥ ï쳌£ ï쳌¨ , ï쳌£ ï쳌¯ ï쳌­ ï쳌° ï쳌© ï쳌´ ï쳌£ ï쳌¨ and other organizations could benefit lease opposing the project was published on ï?? ï?? September from the natural products laboratory to improve quality ï?? ï?? ï?? ï?? . This first attack on the project was followed by a 34 control , production processes and marketing . In addition , series of letters between î?? î?? î?¡ î?¬ î?° î?« and ï쳌¯ ï쳌­ ï쳌© ï쳌¥ ï쳌£ ï쳌¨ ; however , these organizations could assist in disseminating the results no formal meeting could be arranged . To avoid any mis - of the Maya ï쳌© ï쳌£ ï쳌¢ ï쳌§ in the region . Assurances were given understandings regarding the activities of the Maya ï쳌© ï쳌£ ï쳌¢ ï쳌§ , that the project would not start without the proper legal the project halted all plant collecting activities in early framework in place , either contractual or legislative . November ï?? ï?? ï?? ï?? . No further contact was made until after the grant was From that moment on , the conflict escalated on several awarded and the Maya ï쳌© ï쳌£ ï쳌¢ ï쳌§ organized a workshop and fronts : ï쳌¯ ï쳌­ ï쳌© ï쳌¥ ï쳌£ ï쳌¨ started to distribute communiqués to the forum on Mexican experiences on ï쳌¡ ï쳌¢ ï쳌³ in March ï?? ï?? ï?? ï?? as municipalities and communities as well as to transmit one of their initial activities . Representatives of nongovern - radio broadcasts , seeking to halt the project . ï쳌² ï쳌¡ ï쳌¦ ï쳌© also ment organizations , government , the Senate and academic got involved , and a campaign opposing the project was institutions attended the forum where discussions centered launched at the national and international level . While around Mexican experiences that could help both the legis - the local campaign did not change the minds of the com - lative and regulatory process in Mexico and also contribute munities who had granted consent , it did start to cause in the design of the Maya ï쳌© ï쳌£ ï쳌¢ ï쳌§ . ï쳌¯ ï쳌­ ï쳌© ï쳌¥ ï쳌£ ï쳌¨ participated at that problems for other projects at î?? î?? î?¡ î?¬ î?° î?« . At the same time , forum as an observer , sending two representatives from ï쳌² ï쳌¡ ï쳌¦ ï쳌© â?? s campaign put pressure on ï쳌³ ï쳌¥ ï쳌­ ï쳌¡ ï쳌² ï쳌® ï쳌¡ ï쳌´ . Meetings at their board of directors . The presence of representatives of î?? î?? î?¡ î?¬ î?° î?« and in the communities were organized by the different sectors was intended to enhance understanding Maya ï쳌© ï쳌£ ï쳌¢ ï쳌§ as a strategy to clarify the projectâ??s intent and and communication regarding ï쳌¡ ï쳌¢ ï쳌³ . However , these efforts activities . did not achieve specific commitments by legislative or The situation did not improve during the following year , government representatives . On the legislative front , ad - despite efforts by ï쳌³ ï쳌¥ ï쳌­ ï쳌¡ ï쳌² ï쳌® ï쳌¡ ï쳌´ to serve as mediator in the vances were slow . However , the initiatives mentioned in conflict and two meetings of a negotiating committee that the following section are , in a general sense , a response to were held in mid - ï?? ï?? ï?? ï?? . The institutional efforts naturally this and other efforts , including the ï?? ï?? ï?? ï?? Senate Seminar slowed down towards the end of the federal administration and social and legal objections to other bioprospecting in December ï?? ï?? ï?? ï?? , without resolving the conflict . projects that have altogether raised the level of this discus - sion in Mexico . Current Situation Other project activities did not start immediately for During its efforts to obtain ï쳌° ï쳌© ï쳌£ from the communities , the various reasons . Of fundamental importance was that Maya ï쳌© ï쳌£ ï쳌¢ ï쳌§ obtained written consent from ï?? ï?? parajes in ï?? ï?? bioprospecting activities could not start before ï쳌° ï쳌© ï쳌£ was of the ï?? ï?? municipalities in the study area . Eight medicinal obtained from the communities and the permit for col - plant gardens were established upon community request lecting under Article ï?? ï?? ï쳌¢ ï쳌© ï쳌³ of the ï쳌¥ ï쳌¥ ï쳌¥ ï쳌° ï쳌§ ï쳌¡ was issued . and some ï?? ï?? ï?? , ï?? ï?? ï?? ï쳌µ ï쳌³ ï쳌¤ had been secured in funds towards However , activities that could start without delay included the Chiapas â?? Highland Maya Fund . The ethnobotanical training of research assistants , information and negotiation collection database contains almost ï?? , ï?? ï?? ï?? records rep - meetings with the communities from which consent was resenting ï?? , ï?? ï?? ï?? species . Numerous academic exchanges sought , setting up of the natural products laboratory at and workshops were held . Scientific work was carried î?? î?? î?¡ î?¬ î?° î?« , establishment of medicinal plant gardens at the out on a number of related issues , including propagation community level , and scientific collecting for î?? î?? î?¡ î?¬ î?° î?« â?? s of native species , pest damage to medicinal plants , po - ï?? ï?? ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ tential of medicinal plants as a means to control cabbage is discussed . As mentioned above , the granted consent of pests , cultural transmission of ethnobotanical knowledge , the local communities would in time have to be reflected in Maya soil classification , and veterinary ethnomedicine . Of the mechanisms of formal agrarian law which is currently course , no results from bioassays exist since those activi - the only means to canalize ï쳌° ï쳌© ï쳌£ issues , despite the fact that ties never took place . the decisions of the parajes are generally recognized by An example taken from a leaflet shows the kind of the legally defined agrarian community . However , due to information being disseminated in Chiapas during the dis - political pressures the process towards obtaining the formal cussions . Under the heading â?? What is a patent ? â?쳌 is this document of ï쳌° ï쳌© ï쳌£ was interrupted and the formal applica - explanation : â?? A patent is when a person , industry , business , tion was prematurely submitted to the authority . In the university , research center , or government becomes owner absence of such formal document the authority had clear of cultural heritage , biodiversity , ecosystems , and genetic technical grounds to deny the authorization and thereby resources , saying it discovered something in them and it finally burry the controversy . While it may seem that the is the only one that can use them . A patent is taking away project was therefore halted due to a technical deficiency , the sacred and the spiritual in our lands , plants , animals , it seems clear that the lack of enforceability of a federal and lives . â?쳌 The level that discussions in the press and in - decision to upheld the validity of the consent of some ternet reached is beyond description and shows the risks of the communities or parajes meant that the granting of unaccountability in â?? communications â?쳌 . of the collection permits for biotechnological purposes During ï?? ï?? ï?? ï?? , the ï쳌µ ï쳌³ ï쳌¡ government suspended fund - could lead to a deepening of the social conflict . Behind ing for a year , giving time for the conflict to be resolved the technical deficiency there was rather an attempt to halt and the permits obtained . However , the application for a confrontation and alleviate the political tensions generated plant - collecting permit for biotechnological purposes was by the project . finally denied in the midst of political pressures . î?? î?? î?¡ î?¬ î?° î?« Beyond the particularities of the social conditions decided to withdraw from the Maya ï쳌© ï쳌£ ï쳌¢ ï쳌§ indefinitely in in Chiapas that led to the heated controversy around the October ï?? ï?? ï?? ï?? . project and that could not have happened in other parts of Lack of clarity and inadequate adaptation of the prin - the country , the project also highlighted the fact that the ciples set out by the ï쳌£ ï쳌¢ ï쳌¤ into Mexican national legislation existing regulatory framework did not consider the tradi - are part of the reason for the suspension of the project . An tional knowledge associated to genetic resources nor the alternative solution would have been the recognition of the rights of their holders , an issue that needs to be addressed customary rules of these traditional communities which is a at the national level . constant call in all the forums where traditional knowledge Future Access and Benefit - Sharing Regulatory Framework Regarding future legislation there are at least two ini - biosafety . ï쳌¡ ï쳌¢ ï쳌³ regulation is comprised of eleven articles related to access conditions and intellectual property , tiatives in Federal Congress : one submitted by Federal which are summarized in the following paragraphs . The Representative Alejandro Cruz Gutierrez ( Institutional law initiative is of federal jurisdiction and proposes the cre - Revolutionary Party ( ï쳌° ï쳌² ï쳌© ) ) and the other by Federal Senator ation of two competent authorities : a Biosafety Technical Jorge Nordhausen ( NationalAction Party ) . Both initiatives Counsel comprised of scientists and technicians and a are undergoing evaluation by the corresponding Congress 35 Biosafety Mixed Committee including representatives of Committees and have not yet been discussed in the ple - the Ministries of Agriculture , Environment and Health , nary , but they have been published in the Parliamentary 36 as well as representatives of consumers , industry , and Gazette . The Nordhausen initiative has been partially dis - professional associations . Thus , it emphasizes biosafety cussed both by the legislative and some executive branches and not ï쳌¡ ï쳌¢ ï쳌³ . of government . Since a Committee already discussed a The initiative defines the property issue by declaring draft of the law , Congress is likely to consider this initia - genetic resources as a Patrimony of the Nation , and it reaf - tive during the ï?? ï?? ï?? ï?? parliamentary sessions . firms that biodiversity conservation and the sustainable use Although these initiatives may never become laws , of genetic resources are of public interest . These principles briefly describing and commenting on them is useful to could help clarify and simplify State participation in ï쳌¡ ï쳌¢ ï쳌³ show some of the issues that must be dealt with in order agreements . The scope of the law explicitly includes both to achieve a comprehensive framework and a legitimate wild and domesticated species , but no reference to aquatic environment in which to comply with ï쳌£ ï쳌¢ ï쳌¤ rights and ob - species is made . Under this law , access to genetic resources ligations at the national level . would require an authorization from the Biosafety Mixed Committee . A minor contradictory disposition states that The PRI Initiative bioprospecting requires authorization from the Biosafety This text is an attempt to gather into one comprehensive Technical Counsel . Access pursued in collectively owned regulatory framework both access to genetic resources and land ( communities and ejidos ) would require the previ - ï?? ï?? ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : M ï쳌¥ ï쳌¸ ï쳌© ï쳌£ ï쳌¯ ous consent of the General Assembly , notwithstanding the The proposed law is meant to be federal to achieve co - herence and certainty , but implementation can be executed fact that this approach still does not solve the resource locally . Once a law has allocated jurisdiction , transfer of distribution problem . The applicants must sign an Access some power can be coordinated between federal and state Agreement , which must contain : a ) the identification of governments . The industries the law is to regulate are not the resource , its use , and any risks derived from its use ; listed but it is likely to regulate commercial activity as a b ) the material transfer agreement ; c ) the participation of whole . Certain provisions could affect specific industries ; national researchers ; d ) the obligation to share the results for instance , the biotechnology industry is affected both of the research ; and e ) a fee to guarantee compliance . by ï쳌© ï쳌° ï쳌² provisions and access provisions of the initiative . The Committee shall publish in the Official Federation The proposed law is not likely to modify the current Gazette any resolution regarding access applications and segregated agricultural framework , but since it includes will manage a record of related activities . This principle domesticated species , it will fill many gaps and standardize of information and public registry is important and should regulation over different species . Simultaneously , however , remain in any future legislation on ï쳌¡ ï쳌¢ ï쳌³ . it ignores its relationship with the International Treaty on The authorizations could be denied whenever : a ) there Plant Genetic Resources for Food and Agriculture , signed may be adverse effects on human health or on the essential in November ï?? ï?? ï?? ï?? . elements of peoples â?? and communities â?? cultural identity ; With regard to ex situ collections , the proposed law b ) the species or geographic areas involved are considered states the types of authorizations required . Germplasm strategic for national security ; c ) an uncontrollable impact banks seeking to pursue collection in Mexican territory on the environment may occur ; d ) the species involved are must obtain a specific authorization . On the other hand , endemic , rare , or endangered ; e ) ecosystem vulnerability â?? Ex Situ Conservation Centers â?쳌 are recognized by the conditions might increase ; and f ) there is a risk of genetic law and must notify ï쳌³ ï쳌¥ ï쳌­ ï쳌¡ ï쳌² ï쳌® ï쳌¡ ï쳌´ of all Material Transfer erosion . The proposed regulation of intellectual property Agreements related to Mexican resources . However , many is confusing because it excludes from protection any liv - aspects are not regulated and therefore ï쳌· ï쳌§ ï쳌¡ provisions and ing form and any genetic material ( while allowing for the ï쳌® ï쳌¯ ï쳌­ - ï?? ï?? ï?? - ï쳌¥ ï쳌£ ï쳌¯ ï쳌¬ - ï?? ï?? ï?? ï?? regarding scientific collections process patents ) but later gives protection to discoveries . would be applicable . It also confuses patents with plant breeders â?? rights when The enforcement authorities are meant to be ï쳌³ ï쳌¥ ï쳌­ ï쳌¡ ï쳌² ï쳌® ï쳌¡ ï쳌´ referring to patenting requirements ( new , homogeneous , and its dependent and related agencies ( ï쳌© ï쳌® ï쳌¥ and ï쳌° ï쳌² ï쳌¯ ï쳌¦ ï쳌¥ ï쳌° ï쳌¡ ) , stable , distinct , and generic designation ) . Thus , the regu - ï쳌£ ï쳌¯ ï쳌® ï쳌¡ ï쳌¢ ï쳌© ï쳌¯ , the Secretariat of Agriculture , Livestock , Rural lation will need technical clarification . It excludes from Development , Fisheries , and Food ( regarding plant breeders â?? protection the genetic sequence information of a gene in rights ) , and the Mexican Industrial Property Institute . order to eliminate barriers to biotechnological research . If The differences between commercial and noncom - not well defined and delimited , this proposal may , in turn , mercial purposes are defined by exclusion . Furthermore , be in violation of trade - related obligations that Mexico has differences are only evident regarding ex situ regulation ; acquired . It mandates that no rights will be recognized the proposed law does not regulate scientific collection whenever the collected samples were illegally acquired or since its scope is determined by the definition of â?? access â?쳌 whenever collective knowledge of indigenous communi - which only comprises commercial and economic activities . ties or peoples was used . This last principle may seem a If properly developed , this initiative would regulate only reasonable protection but on closer inspection it raises the commercial activities , leaving scientific applications to the question of whether prohibition is valid or if indigenous current regulatory framework . The main characteristics of communities and peoples should be granted the right to the access procedure would run as follows : say yes or no to such forms of protection . â?¢ The applicant must obtain an authorization from a The regulation mandates the Biosafety Mixed Federal Executive Authority ( ï쳌³ ï쳌¥ ï쳌­ ï쳌¡ ï쳌² ï쳌® ï쳌¡ ï쳌´ ) . Committee to review patents or any other intellectual â?¢ An â?? access agreement â?쳌 must be signed with the property right granted outside the country but based upon Federal Government ( ï쳌³ ï쳌¥ ï쳌­ ï쳌¡ ï쳌² ï쳌® ï쳌¡ ï쳌´ , which has juris - national genetic resources in order to allow claims for diction ) , the resource provider , and the intangible royalties or nullity . The exercise of patent review will be component ( traditional knowledge ) provider , if useful , and it is needed input for future legislation ; how - any . ever , it is not easy to see how this is a matter of biosafety ( at least in the way the concept is implemented in the â?¢ If relevant , an authorization must be obtained either context of the ï쳌£ ï쳌¢ ï쳌¤ ) . for collection done by a germplasm bank , transport to any area not specified in the access agreement , The Nordhausen Initiative export of the material collected , or transfer of the rights and obligations given by the access autho - This initiative has a better structure , reflecting a more rization . careful discussion developed by an interdisciplinary group before submitting it to the Senate , although information The issue of State participation in ï쳌¡ ï쳌¢ ï쳌³ activities is a on the extent of consultations is not available . grey area . Particularly , having the State as a party to the ï?? ï?? ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ access agreement is an example where the justification is these institutional problems can be properly addressed by somewhat blurry and might prove to be counterproductive . the proposed law , there is still the issue of legitimacy . This Despite the fact that the initiative is carefully designed , can only be achieved if the process of building a regula - there are some issues that should be addressed in order to tion involves wide public consultation and addresses some obtain greater clarity and coherence . These elements also basic concerns : the privatization of common and / or sacred show the complexities involved in reaching a harmonious resources and knowledge and the patenting of discoveries , transectorial regulation : the procedure and requirements among the most obvious and deeply felt social demands . for authorization are not defined for germplasm banks ; for If limits and criteria can be clearly set , both in access and general - access authorization , the environmental impacts intellectual property regulation , then the framework for requirement is not clearly regulated ; and the participa - bioprospecting activities can be built on a more rational , tion of Mexicans in research and development is required simple , and legitimate fashion . If patents continue to be but not defined . Regarding ï쳌© ï쳌° ï쳌² s , a provision involves the granted around the world on sequences and organisms with evaluation of the proportion of â?? relevant knowledge â?쳌 no clear inventive steps , then the whole of bioprospecting given by each party in order to distribute the resulting is put on the stand and accused of biopiracy . The differ - ï쳌© ï쳌° ï쳌² s . This obligation will be difficult to estimate and may ence between discovery and invention has to be clear cut overemphasize the role of patents over short - term ben - if social legitimacy is to be gained for bioprospecting in efits . It also undermines the intrinsic value of the genetic the medium term . resource in the overall ï쳌¡ ï쳌¢ ï쳌³ scheme because it attends only It is difficult to assess at this point what will emerge to the added value . from the current analysis and discussion of the initiative The proposed law does not resolve the issue of own - within the Senate and the executive branch , but it is most ership of the genetic resource because its provisions likely that substantive changes will be made before it is concerning consent are sometimes based upon the owner passed to the lower chamber . Needless to say , the process of the land and sometimes upon the federal government of public consultation involved in a law of this nature may ( probably assuming that it is the owner of the resource ) . also be time consuming . Both of these factors may imply The initiative should outline the issue more carefully . that it will yet take some time for Mexico to have specific One provision states that any protection of derived access legislation technologies must be shared between the parties . This could represent a form of compulsory license that might Multilateral Level be contrary to international agreements ( such as ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ ) . At this level , there are relevant initiatives related to ï쳌¡ ï쳌¢ ï쳌³ . Another provision requires that intellectual property In particular , a group of countries met in Mexico in ï?? ï?? ï?? ï?? authorities verify the presentation of documentation prov - and jointly issued The Cancun Declaration of Like - Minded ing legal access , prior to the granting of any right . This Megadiversity Countries , hereby they created the â?? Group does constitute an incentive for sustainable use , but unfor - of Like - Minded Megadiverse Countries â?쳌 with the follow - tunately , as phrased this measure allocates the burden of ing objective : â?? to jointly explore ways to . . . harmonize our proof to the intellectual property authority and not to the respective national laws and regulations on the protec - applicant , as it should in order to be effective . tion of biological diversity , including related knowledge Also , giving burden of proof to the victims of an al - as well as access to biological and genetic resources , and leged infringement through â?? conducting acts contrary to 37 the sharing of benefits arising from their sustainable use â?쳌 . the usage and customs of indigenous people , ejidos , and Furthermore , these countries targeted ï?? ï?? specific objectives communities that affect their cultural rights â?쳌 eliminates that broaden the agenda beyond access to genetic resources any advantage the measure could have in promoting access and benefit sharing to include coordination in international to justice . This kind of inequity will have to be dealt with . forums , promotion of in situ and ex situ conservation and Furthermore , regarding traditional knowledge ( referred to investment in endogenous technologies , food safety , cul - as â?? intangible component â?쳌 ) , the stated public record does tural integrity , regulatory harmonization , traditional knowl - not grant any specific positive right to its holders and the edge and innovation , and trade and intellectual property stated certification system is not regulated . Thus , the rights ( including patents , a sui generis system , trademarks overview of this initiative shows that it has a chance of and geographical indications ) . In direct relation to ï쳌¡ ï쳌¢ ï쳌³ and being reviewed and transformed into a workable law if it â?? modern â?쳌 biotechnological development , the Declaration is enhanced technically and if its proponents manage to moves forward in relation to patents when it states the overcome the current impasse into which it has fallen . intent to â?? Seek the creation of an international regime to The three cases of bioprospecting projects and agree - effectively promote and safeguard the fair and equitable ments described above showed that it is urgent to develop a sharing of benefits arising from the use of biodiversity and comprehensive regulatory framework.As this latest section its components . This regime should contemplate , inter alia , shows , the task is far from complete , and it is not only a the following elements : certification of legal provenance matter of legislation . The law has to be built in a coherent of biological materials , prior informed consent and mutu - manner relating to the institutional framework that will enforce it , and this is not an easy task in Mexico . Even if ally agreed terms for the transfer of genetic material , as ï?? ï?? ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : M ï쳌¥ ï쳌¸ ï쳌© ï쳌£ ï쳌¯ requirements for the application and granting of patents , framework of the Convention on Biological Diversity , strictly in accordance with the conditions of access agreed bearing in mind the Bonn Guidelines , an international by the countries of origin . â?쳌 regime to promote and safeguard the fair and equitable Such a regime might be declared incompatible with sharing of benefits arising out of the utilization of genetic some international trade agreements , such as ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ , but resources â?쳌 within the Plan of Implementation adopted it is precisely in these forums , where the presence and by the World Summit on Sustainable Development in common understanding between these countries must be Johannesburg . These efforts culminated recently in the consolidated . The group of â?? Like - minded Megadiverse decision of the Conference of the Parties of the ï쳌£ ï쳌¢ ï쳌¤ to Countries â?쳌 was formally presented at the Sixth ï쳌£ ï쳌¯ ï쳌° of the start negotiation of an international regime on ï쳌¡ ï쳌¢ ï쳌³ of ge - ï쳌£ ï쳌¢ ï쳌¤ , on April ï?? ï?? ï?? ï?? . The effect among other countries and netic resources , at the heart of which are the development regional groups was significant , because it modified the of user measures and coordination mechanisms among ongoing block negotiation scheme and was perceived as legal systems , primarily through the development of the strong and innovative . Certificate of origin / source / legal provenance of genetic The most significant contribution of the group was the introduction of a call for action to â?? negotiate within the resources . Conclusions and Recommendations Resources and Benefit Sharing that contributes clarifica - The transboundary nature of the distribution of genetic tion , principles , and operative mechanisms , including de - resources and its implications for ï쳌¡ ï쳌¢ ï쳌³ can be summarized rived standards for specific sectors and material transfer in the following question : in what role does the owner agreement models . of the land grant any ï쳌° ï쳌© ï쳌£ if the genetic resources are also The use of genetic resources is considered of public found in other regions ? Furthermore , attaching the benefit utility in Mexico , and this simple statement is of great distribution to the granting of ï쳌° ï쳌© ï쳌£ has exclusion implica - importance because it empowers the State to defend a tions , since it would only compensate the person granting public interest . It also has the advantage that the concept ï쳌° ï쳌© ï쳌£ and not other custodians of the resource . Thus , the ap - of public interest has been properly defined in courts and proach of the landowner as the only relevant right holder literature ; thus , it is not a new concept to regulate and may create more problems than benefits . control . Whereas there is a common understanding that A good solution may be the concept of mutually agreed genetic resources belong to the State , the â?? fragmentation of terms , once it has been clearly distinguished from the ï쳌° ï쳌© ï쳌£ the property right â?쳌 into a right of disposition ( on behalf of in the national legislation and provided that the owner of the State ) and right of use ( on behalf on private individuals ) the resource ( the State ) is given the right to grant it . This is helpful in considering different levels of legal interest is one of the justifications for the ï쳌£ ï쳌¢ ï쳌¤ â?? s demand for ï쳌° ï쳌© ï쳌£ in the resource . Such an approach , taken by the ï쳌· ï쳌§ ï쳌¡ is of from the providing country , and it should remain the same great importance ( D ï?­ ï쳌¡ ï쳌º y D ï?­ ï쳌¡ ï쳌º ï?? ï?? ï?? ï?? ) because it allows when translated to national legislation . In turn , the right to for an evaluation based on both the requirements of the negotiate the mutually agreed terms of the specific access owner ( the State ) and those of the holder of the right to a agreement could be the right granted to the owner of the sustainable use of the resource . Furthermore , it provides land which could be justified as a right to make a sustain - the basis for having the owner of the land as negotiator of able use of the genetic resources found in his property . the mutually agreed terms . Obviously , this proposal implies a deep change in the We must consider if a sector - specific approach is more perception of the role of the landowner and will require convenient than a comprehensive approach . Due to the some other adjustments . importance of the issue , an initial comprehensive regula - The only articles directly regulating biotechnological tion , comprising all species , is necessary in order to achieve bioprospecting in Mexico are Article ï?? ï?? ï쳌¢ ï쳌© ï쳌³ of ï쳌¥ ï쳌¥ ï쳌¥ ï쳌° ï쳌§ ï쳌¡ coherence , and then continuing with a sector - by - sector and articles ï?? ï?? ï?? and ï?? ï?? ï?? of ï쳌³ ï쳌¦ ï쳌¤ ï쳌§ ï쳌¡ . Despite the fact that specific regulation through official standards . the ï쳌³ ï쳌¦ ï쳌¤ ï쳌§ ï쳌¡ does make the ï쳌£ ï쳌¢ ï쳌¤ â?? s comprehensive recogni - The development of policies regarding genetic re - tion of the undeniable relationship between environmental sources has to consider scenarios of diffuse property , of regulation , rural development , traditional knowledge and common goods , and of collective innovation . To address practices , industrial applications , trade , and intellectual these issues , profound changes in legal principles have to property , it has a limited scope . Therefore , even though be considered , since most property rights are recognized both instruments incorporate the two main principles stated for individuals and not for collective entities . Many legal in the ï쳌£ ï쳌¢ ï쳌¤ : ( prior informed consent and benefit sharing ) , concepts whose validity is taken for granted may be in the ï쳌¡ ï쳌¢ ï쳌³ legal framework as a whole lacks that important serious contradiction with collective rights . Traditional recognition . Since access to genetic resources is differ - knowledge and genetic resources are some of the areas in ent from other processes of appropriation of biological which collective rights have a clear and positive contribu - resources , it seems reasonable to continue the efforts to develop a comprehensive Law on Access to Genetic tion to make in the development of the rights of farmers ï?? ï?? ï?? ï?? ï?? ï?? ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌¡ ï쳌® ï쳌¤ S ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¥ ï쳌³ ï쳌³ ï쳌© A ï쳌£ ï쳌£ and indigenous peoples . proach reaches a consensus , it will probably prove useful The discussions of biopiracy and bioprospecting have to consolidate a public policy on these issues , setting the taken place and found their way into regulation in many stage for a deeper discussion on the path Mexico will take countries for more than a decade now ( e.g . , India ) . In the in terms of biotechnological development and the prospect - Pacific region , countries like the Philippines and Malaysia ing and appropriation of our own biological and genetic ( see Chapters ï?? and ï?? ï?? ) have made strong steps forward resources . Such an approach need not affect private invest - in regulating access , as has the Andes region ( see Chapter ment or property . The ï쳌£ ï쳌¢ ï쳌¤ is an international agreement , ï?? ) with its debates and common regulation . Mexico is lag - but countries adhering to it need to adjust to local condi - ging behind in the participation in these debates . Mexicoâ??s tions . The contradictions implicit in this process touch the megadiversity is principally distributed in indigenous and fibers of nationalism and radicalize reactions against the peasant lands , and the political perception these sectors commodification of life ( G ï?¶ ï쳌² ï쳌§ and B ï쳌² ï쳌¡ ï쳌® ï쳌¤ ï?? ï?? ï?? ï?? ) . have of bioprospecting is fundamental for its future It is interesting to note that many of the social de - legitimacy . Appropriate access and transfer of relevant mands against bioprospecting can be read as demands for technologies are tied together and by definition need an a stronger State involvement . In Mexico , in the last three actor to give or receive the technology . decades , we have seen the systematic withdrawal of the Further discussions on the use of genetic resources State from the rural sector and the costs are visible . The in Mexico may well lead to the consideration of these lack of presence in terms of support and technical advice resources as a priority area for the nation . If such an ap - for development in these areas is a central component of Social conflict , weak structures , and wider problems are poorly understood . Social participation is perceived as difficult and costly . Collective Public National Research oples Pe Institutes Legally recognized agrarian communities Individual Other Research Private Commercial ealer onal h raditi T Institutes Partner asant Pe demic Aca ercial Comm ncrete Co iffuse D ntent I ctors A Issues of market , intellectual property , and third party transfers are poorly understood , uncertain , and costly to monitor . They are perceived as piracy . The barriers : Geographical : Access , research , and development occur in different locations Temporal : Ten or more years to get benefits Legal : Different jurisdictions Ethical : Divergent views on property and ethical uses Capacity : Different relative costs of access to legal advice and to justice herâ??s ch ot nd ea dersta to un at fail ms th aradig ring p diffe s . Two oper devel and iders prov tween ers be barri ï?? . The ure Fig ent . elopm al dev merci nd com on , a ovati s , inn ource ic res genet ws on wn vie eir o by th ivided are d cerns nd con ies a realit ostly ned m wide being rently is cur that he gap ach t to bre eded are ne ness aware and ilding ity bu capac ts in effor trong S ings . rstand sunde by mi ï?? ï?? ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : M ï쳌¥ ï쳌¸ ï쳌© ï쳌£ ï쳌¯ the perception of social sectors towards bioprospecting , in intellectual property regulation . If so , the framework for bioprospecting activities can be built in a more rational , a sense , saying to the State , â?? you have not been here for simple , and legitimate fashion . ï?? ï?? years and now you are here to sell our resources â?쳌 . In A future law on access has to face the situation of a general sense they are right , and Mexico needs to face ex situ collections and develop a creative solution to the its own contradictions . However , the implementation of problem ; the legal situation of these collections bears di - the ï쳌£ ï쳌¢ ï쳌¤ in all its components , particularly Articles ï?? , ï?? , rectly on the issue of ï쳌¡ ï쳌¢ ï쳌³ and cannot be overlooked during and ï?? may help alleviate some of them . Thus , the extent the consultation process . This includes the legal status of of the State involvement is a difficult issue . Having the material collected prior to the ï쳌£ ï쳌¢ ï쳌¤ â?? s entry into force , of State involved in all ï쳌¡ ï쳌¢ ï쳌³ activities might create excessive intellectual property rights , and of biosafety , since refer - inefficiency in the ï쳌¡ ï쳌¢ ï쳌³ management and might be read as ence collections can be used to monitor and develop policy a system that does not facilitates access but hinders it . related to these issues . Ex situ collections are costly , and The implications of property rights and commercial it is important to develop them as institutions that serve privileges implicit in patent rights must be fully compre - at the same time the purposes of conservation , access to hended in order to achieve a wider understanding that the genetic resources , and reference material for monitoring part of knowledge being â?? taken â?쳌 from the public domain genetically modified organisms and ï쳌© ï쳌° ï쳌² s . ( the part related to innovation ) is only a small fraction of The development of a comprehensive legal framework the whole , is only for a limited period of time , and is sub - is urgently needed . The single most important issue to ject to several exceptions or limitations . This emphasis on consider is that these frameworks have to be achieved the temporal limitation of the privileges of patents is much through wide consultation and discussions if they are to be too often overlooked . Besides this temporal limitation to legitimate ; in particular , there must be consultation with in - the appropriation process , it is also important to consider digenous peoples , peasant organizations , and civil society . carefully the patenting criteria in specific innovation and The temptation of legal reform without social legitimacy industrial sectors , particularly in discussions of the revision has dominated many processes in Mexico . Such a process of Article ï?? ï?? . ï?? . b of the ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ Agreement within the ï쳌· ï쳌´ ï쳌¯ . may be complex but it has to be undertaken seriously by This review , and the adoption of more stringent criteria the different political parties in Congress and by execu - for inventions , is a key factor in resolving adverse public tive authorities working on these issues . A former official perception to patent practices and in developing respon - of ï쳌³ ï쳌¥ ï쳌­ ï쳌¡ ï쳌² ï쳌® ï쳌¡ ï쳌´ ( ï?? ï?? ï?? ï?? â?? ï?? ï?? ï?? ï?? ) declared to Nature magazine sible practices in biotech - related ï쳌© ï쳌° ï쳌² . that â?? Mexico lacks a legal framework for bioprospect - The approach of demanding proof of legal provenance ing . I would not advise undertaking one of these projects of the biological material in applications for patents has now â?쳌 ( D ï쳌¡ ï쳌¬ ï쳌´ ï쳌¯ ï쳌® ï?? ï?? ï?? ï?? ) . Is such a recommendation still been discussed for many years now ( D ï쳌µ ï쳌´ ï쳌¦ ï쳌© ï쳌¥ ï쳌¬ ï쳌¤ ï?? ï?? ï?? ï?? ) and valid ? Probably yes , particularly if the project involves has been examined in working groups of the ï쳌£ ï쳌¢ ï쳌¤ . In fact , indigenous territories or traditional knowledge . The main decision ï쳌¶ ï쳌© / ï?? ï?? of the ï?? th ï쳌£ ï쳌¯ ï쳌° to the ï쳌£ ï쳌¢ ï쳌¤ mandates further issues to be addressed are not technical or regulatory , study of the â?? feasibility of an internationally recognized and we cannot afford to be politically naïve about these certificate of origin system as evidence of prior informed processes . Figure ï?? delineates the barriers that polarize consent and mutually agreed terms â?쳌 . The same decision positions on ï쳌¡ ï쳌¢ ï쳌³ projects . Breaching these barriers is a states that â?? Parties are invited to encourage the disclosure priority . As simple as they may seem , capacity building of the origin of genetic resources and traditional knowledge and awareness raising on the issue of genetic resource in application for intellectual property rights â?쳌 . conservation , access , and prospecting has to be taken seri - This articulation between intellectual property rights ously so that a policy that deals with these problems with and ï쳌¡ ï쳌¢ ï쳌³ can only be resolved with legitimacy if the process legitimacy can be built . of building a regulation involves wide consultation and limits and criteria can be clearly set , both in access and Acknowledgements This text is dedicated to Brent and Eloise Ann Berlin , his forefathers , he will inevitably find himself among their written work . with the certainty that when we are all gone and a young Maya of the highlands is in search for the knowledge of References A ï쳌¬ ï쳌¡ ï쳌§ ï?³ ï쳌® - C ï쳌¡ ï쳌® ï쳌¯ A . ï?? ï?? ï?? ï?? . El r ï쳌¤ ï쳌³ ï쳌° ï쳌¡ ï?? : Un ejemplo de utilización B ï쳌¥ ï쳌² ï쳌¬ ï쳌© ï쳌® B . , E.A B ï쳌¥ ï쳌² ï쳌¬ ï쳌© ï쳌® , J.C . F ï쳌¥ ï쳌² ï쳌® ï?¡ ï쳌® ï쳌¤ ï쳌¥ ï쳌º - U ï쳌§ ï쳌¡ ï쳌¬ ï쳌¤ ï쳌¥ , de un recurso genético . p . ï?? ï?? ï?? â?? ï?? ï?? ï?? in A . A ï쳌² ï쳌² ï쳌¯ ï쳌£ ï쳌¨ ï쳌¡ y L . G ï쳌¡ ï쳌² ï쳌£ ï?­ ï쳌¡ - B ï쳌¡ ï쳌² ï쳌² ï쳌© ï쳌¯ ï쳌³ , D . P ï쳌µ ï쳌¥ ï쳌´ ï쳌´ , R . N ï쳌¡ ï쳌³ ï쳌¨ , and M . J . L ï쳌¡ ï쳌² ï쳌³ ï쳌¯ ï쳌® ( ed . ) Senado de la República , Seminario G ï쳌¯ ï쳌® ï쳌º ï?¡ ï쳌¬ ï쳌¥ ï쳌º - E ï쳌³ ï쳌° ï쳌© ï쳌® ï쳌¯ ï쳌³ ï쳌¡ . ï?? ï?? ï?? ï?? . The Maya ï쳌© ï쳌£ ï쳌¢ ï쳌§ : drug sobre Legislación de Acceso a los Recursos Genéticos . discovery , medical ethnobiology , and alternative forms of Memoria , México . economic development in the highland Maya region of ï?? ï?? ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ Chiapas , Mexico . Pharmaceutical Biology ï?? ï?? : ï?? ï?? ï?? â?? ï?? ï?? ï?? . amendment published in the Federation Official Gazette on ï?? August ï?? ï?? ï?? ï?? . C ï쳌¡ ï쳌­ ï쳌¢ ï쳌¥ ï쳌² ï쳌² ï쳌¯ ï쳌³ S . ï?? ï?? ï?? ï?? . El pasado como un prólogo , haciendo M ï쳌¥ ï쳌¸ ï쳌© ï쳌£ ï쳌¡ ï쳌® C ï쳌¯ ï쳌® ï쳌§ ï쳌² ï쳌¥ ï쳌³ ï쳌³ . ï?? ï?? ï?? ï?? . Constitution of the United States puentes entre el mundo moderno y el mundo tradicional . of Mexico . Last amendment to Article ï?? ï?? published in the p . ï?? ï?? â?? ï?? ï?? in A . A ï쳌² ï쳌² ï쳌¯ ï쳌£ ï쳌¨ ï쳌¡ y J . L ï쳌¡ ï쳌² ï쳌³ ï쳌¯ ï쳌® ( ed . ) Senado de la Federation Official Gazette on ï?? March ï?? ï?? ï?? ï?? . República , Seminario sobre Legislación de Acceso a los Recursos Genéticos . Memoria , México . M ï쳌¥ ï쳌¸ ï쳌© ï쳌£ ï쳌¡ ï쳌® C ï쳌¯ ï쳌® ï쳌§ ï쳌² ï쳌¥ ï쳌³ ï쳌³ . ï?? ï?? ï?? ï?? a . Plant Varieties Federal Act . Published in the Federation Official Gazette on ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌¥ ï쳌¬ ï쳌¡ I . ï?? ï?? ï?? ï?? . Bioprospecting : Myths , realities and poten - October ï?? ï?? ï?? ï?? . tial impacts on sustainable development . p . ï?? ï?? â?? ï?? ï?? in M.E . P ï쳌¡ ï쳌¬ ï쳌­ and I . C ï쳌¨ ï쳌¡ ï쳌° ï쳌¥ ï쳌¬ ï쳌¡ ( eds . ) Mycology in sustainable M ï쳌¥ ï쳌¸ ï쳌© ï쳌£ ï쳌¡ ï쳌® C ï쳌¯ ï쳌® ï쳌§ ï쳌² ï쳌¥ ï쳌³ ï쳌³ . ï?? ï?? ï?? ï?? b . Ecological Equilibrium and development : Expanding concepts , vanishing borders . Environment Protection General Act . Published in the Parkway Publishers Inc . , North Carolina , î?° î?¬ î?? . Federation Official Gazette on ï?? ï?? January ï?? ï?? ï?? ï?? and amendment published on ï?? ï?? December ï?? ï?? ï?? ï?? . C ï쳌¯ ï쳌² ï쳌² ï쳌¥ ï쳌¡ C . ï?? ï?? ï?? ï?? . Access to plant genetic resources and intel - lectual property rights . ï쳌¦ ï쳌¡ ï쳌¯ â?? ï쳌£ ï쳌§ ï쳌² ï쳌¦ ï쳌¡ , Rome , Italy . ï쳌µ ï쳌² ï쳌¬ : M ï쳌¥ ï쳌¸ ï쳌© ï쳌£ ï쳌¡ ï쳌® C ï쳌¯ ï쳌® ï쳌§ ï쳌² ï쳌¥ ï쳌³ ï쳌³ . ï?? ï?? ï?? ï?? . Constitution of the United States http : / / www.fao.org / ag / cgrfa . of Mexico . Last amendment to Article ï?? ï?? published in the Federation Official Gazette on ï?? ï?? June ï?? ï?? ï?? ï?? . C ï쳌¯ ï쳌³ ï쳌³ ï쳌© ï쳌¯ - D ï쳌© ï쳌¡ ï쳌º J . ï?? ï?? ï?? ï?? . La Reforma Constitucional en materia indígena . Cuadernos de Trabajo del Departamento de M ï쳌¥ ï쳌¸ ï쳌© ï쳌£ ï쳌¡ ï쳌® C ï쳌¯ ï쳌® ï쳌§ ï쳌² ï쳌¥ ï쳌³ ï쳌³ . ï?? ï?? ï?? ï?? . Wildlife General Act . Published in Derecho , Vol . ï?? ï?? , ï쳌© ï쳌´ ï쳌¡ ï쳌­ , México . the Federation Official Gazette on ï?? July ï?? ï?? ï?? ï?? . C ï쳌µ ï쳌¡ ï쳌¤ ï쳌¥ ï쳌² ï쳌® ï쳌¯ ï쳌³ A ï쳌§ ï쳌² ï쳌¡ ï쳌² ï쳌© ï쳌¯ ï쳌³ . ï?? ï?? ï?? ï?? . Biopiratería y bioprospección . M ï쳌¥ ï쳌¸ ï쳌© ï쳌£ ï쳌¡ ï쳌® C ï쳌¯ ï쳌® ï쳌§ ï쳌² ï쳌¥ ï쳌³ ï쳌³ . ï?? ï?? ï?? ï?? . Constitution of the United States Número especial de Cuadernos Agrarios Nueva Ã?poca of Mexico . Last amendment to Article ï?? published in the Número ï?? ï?? , México . Federation Official Gazette on ï?? August ï?? ï?? ï?? ï?? . D ï쳌¡ ï쳌¬ ï쳌´ ï쳌¯ ï쳌® R . ï?? ï?? ï?? ï?? . Political uncertainty halts bioprospecting in M ï쳌¥ ï쳌¸ ï쳌© ï쳌£ ï쳌¡ ï쳌® C ï쳌¯ ï쳌® ï쳌§ ï쳌² ï쳌¥ ï쳌³ ï쳌³ . ï?? ï?? ï?? ï?? . Criminal Code . Amendment pub - Mexico . Nature ï?? ï?? ï?? : ï?? ï?? ï?? . lished on the Federation Official Gazette on ï?? February ï?? ï?? ï?? ï?? . D ï?­ ï쳌¡ ï쳌º y D ï?­ ï쳌¡ ï쳌º M . ï?? ï?? ï?? ï?? . El aprovechamiento de los recursos M ï쳌¥ ï쳌¸ ï쳌© ï쳌£ ï쳌¡ ï쳌® C ï쳌¯ ï쳌® ï쳌§ ï쳌² ï쳌¥ ï쳌³ ï쳌³ . ï?? ï?? ï?? ï?? . Sustainable Forestry Development naturales . Hacia un nuevo discurso patrimonial . Revista General Act . Published in the Federation Official Gazette de Investigaciones Jurídicas : Vol . ï?? ï?? , Escuela Libre de on ï?? ï?? February ï?? ï?? ï?? ï?? . Derecho , México . P ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌¤ ï쳌© ï쳌³ A . ï?? ï?? ï?? ï?? . Extremophiles . Nature Biotechnology ï?? ï?? . D ï쳌µ ï쳌´ ï쳌¦ ï쳌© ï쳌¥ ï쳌¬ ï쳌¤ G . ï?? ï?? ï?? ï?? . Intellectual property rights , trade and P ï쳌¯ ï쳌³ ï쳌® ï쳌¥ ï쳌² R . ï?? ï?? ï?? ï?? . Economic analysis of law . Aspen Publishers , biodiversity : Seeds and plant varieties . ï쳌© ï쳌µ ï쳌£ ï쳌® , Earthscan ï쳌µ ï쳌³ ï쳌¡ . Publications , London , ï쳌µ ï쳌« . ï쳌° ï쳌² ï쳌¯ ï쳌¦ ï쳌¥ ï쳌° ï쳌¡ ï?? ï?? ï?? ï?? . Popular denunciation regarding ï쳌µ ï쳌® ï쳌¡ ï쳌­ - Diversa F ï쳌¥ ï쳌² ï쳌® ï?¡ ï쳌® ï쳌¤ ï쳌¥ ï쳌º J . , A . A ï쳌¬ ï쳌¤ ï쳌¡ ï쳌­ ï쳌¡ , and C . L ï쳌¯ ï쳌° ï쳌¥ ï쳌º - S ï쳌© ï쳌¬ ï쳌¶ ï쳌¡ . ï?? ï?? ï?? ï?? . Agreement . File No . ï?? ï?? ï?? / ï?? ï?? ï?? / ï?? ï?? . Federal Attorney for the Conocimiento tradicional de la biodiversidad : conser - Protection of the Environment . vación , uso sustentable y reparto de beneficios . Gaceta R ï쳌¡ ï쳌­ ï?­ ï쳌² ï쳌¥ ï쳌º - C ï쳌¡ ï쳌³ ï쳌© ï쳌¬ ï쳌¬ ï쳌¡ ï쳌³ V.M . ï?? ï?? ï?? ï?? . Tierra , diferencia y poder . Ecológica : Número ï?? ï?? , Instituto Nacional de Ecología , Violaciones a los derechos humanos indígenas en México : México . ï?? ï?? ï?? ï?? - ï?? ï?? ï?? ï?? . Universidad Iberoamericana A.C . México . F ï쳌µ ï쳌£ ï쳌£ ï쳌© ï쳌¬ ï쳌¬ ï쳌¯ D . , L . S ï쳌¥ ï쳌¡ ï쳌² ï쳌³ , and P . S ï쳌´ ï쳌¡ ï쳌° ï쳌¬ ï쳌¥ ï쳌´ ï쳌¯ ï쳌® . ( eds . ) ï?? ï?? ï?? ï?? . R ï쳌¯ ï쳌³ ï쳌¥ ï쳌® ï쳌´ ï쳌¨ ï쳌¡ ï쳌¬ J.P . , D . B ï쳌¥ ï쳌£ ï쳌« , A . B ï쳌¨ ï쳌¡ ï쳌´ , J . B ï쳌© ï쳌³ ï쳌· ï쳌¡ ï쳌³ , L . B ï쳌² ï쳌¡ ï쳌¤ ï쳌¹ , Biodiversity in trust . ï쳌£ ï쳌§ ï쳌© ï쳌¡ ï쳌² and The Cambridge K . B ï쳌² ï쳌© ï쳌¤ ï쳌¢ ï쳌¯ ï쳌¡ ï쳌² ï쳌¤ , S . C ï쳌¯ ï쳌¬ ï쳌¬ ï쳌© ï쳌® ï쳌³ , G . C ï쳌² ï쳌¡ ï쳌§ ï쳌§ , J . E ï쳌¤ ï쳌· ï쳌¡ ï쳌² ï쳌¤ ï쳌³ , A . University Press , Cambridge , ï쳌µ ï쳌« . F ï쳌¡ ï쳌© ï쳌² ï쳌¦ ï쳌© ï쳌¥ ï쳌¬ ï쳌¤ , M . G ï쳌¯ ï쳌´ ï쳌´ ï쳌¬ ï쳌© ï쳌¥ ï쳌¢ , L.A . G ï쳌³ ï쳌£ ï쳌¨ ï쳌· ï쳌© ï쳌® ï쳌¤ , Y . H ï쳌¡ ï쳌¬ ï쳌¬ ï쳌¯ ï쳌£ ï쳌« , G ï쳌¯ ï쳌¬ ï쳌¬ ï쳌© ï쳌® M . ï?? ï?? ï?? ï?? . An intellectual property rights framework R . H ï쳌¡ ï쳌· ï쳌« ï쳌³ , R . H ï쳌¥ ï쳌§ ï쳌¹ ï쳌¥ ï쳌¬ ï쳌© , G . J ï쳌¯ ï쳌¨ ï쳌® ï쳌³ ï쳌¯ ï쳌® , G.T . K ï쳌¥ ï쳌µ ï쳌³ ï쳌£ ï쳌¨ , E.E . for biodiversity prospecting . p . ï?? ï?? ï?? â?? ï?? ï?? ï?? in W.V . R ï쳌¥ ï쳌© ï쳌¤ , L ï쳌¹ ï쳌¯ ï쳌® ï쳌³ , R . M ï쳌© ï쳌¬ ï쳌¬ ï쳌¥ ï쳌² , J . R ï쳌¯ ï쳌¤ ï쳌­ ï쳌¡ ï쳌® , J . R ï쳌¯ ï쳌³ ï쳌« ï쳌¯ ï쳌³ ï쳌« ï쳌© , and D . S.A . L ï쳌¡ ï쳌© ï쳌² ï쳌¤ , C.A . M ï쳌¥ ï쳌¹ ï쳌¥ ï쳌² , R . G ï?¡ ï쳌­ ï쳌¥ ï쳌º , A . S ï쳌© ï쳌´ ï쳌´ ï쳌¥ ï쳌® ï쳌¦ ï쳌¥ ï쳌¬ ï쳌¤ , S ï쳌© ï쳌¥ ï쳌§ ï쳌¥ ï쳌¬ - C ï쳌¡ ï쳌µ ï쳌³ ï쳌¥ ï쳌¹ . ï?? ï?? ï?? ï?? . Combining high risk science with D.H . J ï쳌¡ ï쳌® ï쳌º ï쳌¥ ï쳌® , M.G . G ï쳌¯ ï쳌¬ ï쳌¬ ï쳌© ï쳌® , and C . J ï쳌µ ï쳌­ ï쳌¡ ( eds . ) . ambitious social and economic goals . Pharmaceutical Biodiversity prospecting : Using genetic resources for Biology ï?? ï?? : ï?? â?? ï?? ï?? . sustainable development . World Resources Institute , S ï쳌¡ ï쳌² ï쳌µ ï쳌« ï쳌¨ ï?¡ ï쳌® J . , J . S ï쳌¯ ï쳌¢ ï쳌¥ ï쳌² ï?³ ï쳌® , and J . L ï쳌¡ ï쳌² ï쳌³ ï쳌¯ ï쳌® - G ï쳌µ ï쳌¥ ï쳌² ï쳌² ï쳌¡ . ï?? ï?? ï?? ï?? . Washington ï쳌¤ ï쳌£ ï쳌µ ï쳌³ ï쳌¡ . Biological conservation in a high beta diversity coun - G ï?¶ ï쳌² ï쳌§ C . and U . B ï쳌² ï쳌¡ ï쳌® ï쳌¤ . ï?? ï?? ï?? ï?? . Global environmental politics try . p . ï?? ï?? ï?? â?? ï?? ï?? ï?? in F . ï쳌¤ ï쳌© C ï쳌¡ ï쳌³ ï쳌´ ï쳌² ï쳌© and T . Y ï쳌¯ ï쳌µ ï쳌® ï쳌¥ ï쳌³ ( eds . ) and competition between nation - states : On the regulation Biodiversity , science and development : Towards a new of biological diversity . Review of International Political partnership . î?? î?? î?? International , Oxford , ï쳌µ ï쳌« . Economy ï?? : ï?? ï?? ï?? â?? ï?? ï?? ï?? . S ï쳌¨ ï쳌µ ï쳌¬ ï쳌­ ï쳌¡ ï쳌® , S . ï?? ï?? ï?? ï?? . Patent absurdities . The Sciences Jan / Feb : H ï쳌¡ ï쳌² ï쳌¶ ï쳌¥ ï쳌¹ N . ï?? ï?? ï?? ï?? . Globalization and resistance in post - cold ï?? ï?? â?? ï?? ï?? . war Mexico : Difference , citizenship and biodiversity con - S ï쳌´ ï쳌¡ ï쳌¶ ï쳌¥ ï쳌® ï쳌¨ ï쳌¡ ï쳌§ ï쳌¥ ï쳌® R . ï?? ï?? ï?? ï?? . Hacia el derecho de autonomía flicts in Chiapas . Third World Quarterly ï?? ï?? : ï?? ï?? ï?? ï?? â?? ï?? ï?? ï?? ï?? . en México . p . ï?? â?? ï?? ï?? in C . B ï쳌µ ï쳌² ï쳌§ ï쳌µ ï쳌¥ ï쳌´ ï쳌¥ and A . M ï쳌¡ ï쳌¹ ï쳌¯ ï쳌² H ï쳌¥ ï쳌² ï쳌³ ï쳌£ ï쳌¨ P . and J . L ï쳌¡ ï쳌² ï쳌³ ï쳌¯ ï쳌® . ï?? ï?? ï?? ï?? . Traditional medicine , biologi - ( Coord . ) México : Experiencias de autonomía indígena . cal resources and intellectual property rights : A view Documento ï쳌© ï쳌§ ï쳌· ï쳌© ï쳌¡ ï?? ï?? . Dinamarca . from Mexico . Paper presented at the ï쳌¡ ï쳌° ï쳌¥ ï쳌£ Symposium on S ï쳌µ ï쳌° ï쳌² ï쳌¥ ï쳌­ ï쳌¥ C ï쳌¯ ï쳌µ ï쳌² ï쳌´ . ï?? ï?? ï?? ï?? . Hierarchy of international treaties in Traditional Medicine , Hong Kong , China . Unpublished relation to other laws , Ninth Epoch , Federation Judicial manuscript . Weekly Publication , Vol . ï쳌¸ , November . Thesis ï쳌° . ï쳌¬ ï쳌¸ ï쳌¸ ï쳌¶ ï쳌© ï쳌© / ï?? ï?? . M ï쳌¥ ï쳌¸ ï쳌© ï쳌£ ï쳌¡ ï쳌® C ï쳌¯ ï쳌® ï쳌§ ï쳌² ï쳌¥ ï쳌³ ï쳌³ . ï?? ï?? ï?? ï?? . Constitution of the United States S ï쳌· ï쳌¡ ï쳌® ï쳌³ ï쳌¯ ï쳌® T . ï?? ï?? ï?? ï?? . The appropriation of evolutionâ??s values : of Mexico . Last amendment to Article ï?? ï?? published in the An institutional analysis of intellectual property regimes Federation Official Gazette on ï?? ï?? January ï?? ï?? ï?? ï?? . and biodiversity conservation . p ï?? ï?? ï?? â?? ï?? ï?? ï?? in T . S ï쳌· ï쳌¡ ï쳌® ï쳌³ ï쳌¯ ï쳌® . M ï쳌¥ ï쳌¸ ï쳌© ï쳌£ ï쳌¡ ï쳌® C ï쳌¯ ï쳌® ï쳌§ ï쳌² ï쳌¥ ï쳌³ ï쳌³ . ï?? ï?? ï?? ï?? . Industrial Property Act . Major Intellectual property rights and biodiversity conservation : ï?? ï?? ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : M ï쳌¥ ï쳌¸ ï쳌© ï쳌£ ï쳌¯ An interdisciplinary analysis of the values of medicinal T ï쳌¹ ï쳌¬ ï쳌¥ ï쳌² H . , K.S . B ï쳌² ï쳌¯ ï쳌· ï쳌® J ï쳌² . and K . W ï쳌© ï쳌¬ ï쳌³ ï쳌¯ ï쳌® . ï?? ï?? ï?? ï?? . Swallowtail plants . Cambridge University Press , ï쳌µ ï쳌« . butterflies of the Americas : A study in biological dynam - ics , ecological diversity , biosystemaitcs and conservation . ï쳌´ ï쳌¥ ï쳌® K ï쳌¡ ï쳌´ ï쳌¥ K . and S.A . L ï쳌¡ ï쳌© ï쳌² ï쳌¤ . ï?? ï?? ï?? ï?? . The commercial use of Scientific Publishers , Gainesville , ï쳌¦ ï쳌¬ ï쳌µ ï쳌³ ï쳌¡ . biodiversity : Access to genetic resources and benefit shar - ing . Earthscan Publications Ltd . , London , ï쳌µ ï쳌« . ï쳌· ï쳌© ï쳌° ï쳌¯ ï?? ï?? ï?? ï?? . Intellectual property needs and expectations of traditional knowledge holders . Report on Fact - find - T ï쳌¥ ï쳌® ï쳌¡ - R ï쳌¡ ï쳌­ ï쳌© ï쳌² ï쳌¥ ï쳌º , F . ï?? ï?? ï?? ï?? . Derecho constitucional mexicano . ing Missions on Intellectual Property and Traditional Editorial Porrúa , México . Knowledge . Geneva , Switzerland . T ï쳌© ï쳌­ ï쳌­ ï쳌¥ ï쳌² ï쳌­ ï쳌¡ ï쳌® ï쳌® B.N . , G . W ï?¤ ï쳌£ ï쳌¨ ï쳌´ ï쳌¥ ï쳌² , S . V ï쳌¡ ï쳌¬ ï쳌£ ï쳌© ï쳌£ , B . H ï쳌µ ï쳌´ ï쳌£ ï쳌¨ ï쳌© ï쳌® ï쳌³ ï쳌¯ ï쳌® , ï쳌· ï쳌´ ï쳌¯ ï?? ï?? ï?? ï?? . The Convention on Biological Diversity and the C . C ï쳌¡ ï쳌³ ï쳌¬ ï쳌¥ ï쳌² , J . H ï쳌¥ ï쳌® ï쳌º ï쳌¥ ï쳌¬ , S . R ï쳌¡ ï쳌­ , F . C ï쳌µ ï쳌² ï쳌² ï쳌© ï쳌­ , R . M ï쳌¡ ï쳌® ï쳌¡ ï쳌« , Agreement on Trade Related Aspects of Intellectual S . Fr ï쳌¡ ï쳌® ï쳌º ï쳌¢ ï쳌¬ ï쳌¡ ï쳌µ , W . M ï쳌¡ ï쳌© ï쳌¥ ï쳌³ ï쳌¥ , D . G ï쳌¡ ï쳌¬ ï쳌© ï쳌® ï쳌© ï쳌³ , E . S ï쳌µ ï쳌¡ ï쳌² ï쳌¥ ï쳌º , R . Property , Committee on Trade and Environment , F ï쳌¯ ï쳌² ï쳌´ ï쳌µ ï쳌® ï쳌¡ ï쳌´ ï쳌¯ , E . S ï쳌¡ ï쳌¡ ï쳌¶ ï쳌¥ ï쳌¤ ï쳌² ï쳌¡ , R . B ï쳌¹ ï쳌¥ , R . M ï쳌¡ ï쳌´ ï쳌¡ , and G . Secretary Note , ï쳌· ï쳌´ / ï쳌£ ï쳌´ ï쳌¥ / ï쳌· / ï?? ï?? . M ï쳌¯ ï쳌® ï쳌´ ï쳌¥ ï쳌® ï쳌¥ ï쳌§ ï쳌² ï쳌¯ . ï?? ï?? ï?? ï?? . The Latin American ï쳌© ï쳌£ ï쳌¢ ï쳌§ : The First Five Years . Pharmaceutical Biology ï?? ï?? : ï?? ï?? â?? ï?? ï?? . Endnotes 1 Although this sector has provisions vaguely related to genetic scientific ones . resources and biotechnology , they were not developed in response 15 The definition of bioprospecting is problematic : two activities are to a changing legal framework in access and benefit sharing . confused . Biotechnological use assumes economic objectives , 2 and the presence of intellectual property considerations usually is Nonetheless , the regulatory meaning of characterizing species as perceived in association with biotechnological purposes . Regarding â?? strategic â?쳌 is still unknown . scientific collection regulation , ï쳌· ï쳌§ ï쳌¡ and the ï쳌® ï쳌¯ ï쳌­ - ï?? ï?? ï?? - ï쳌¥ ï쳌£ ï쳌¯ ï쳌¬ - ï?? ï?? ï?? ï?? 3 This is evident from the recently agreed upon text of the explicitly exclude economic and biotechnological purposes . Bonn Guidelines on Access and Benefit Sharing . The Bonn 16 Biotechnology is defined in article ï?? of the ï쳌¥ ï쳌¥ ï쳌¥ ï쳌° ï쳌§ ï쳌¡ , incorporating Guidelines , document ï쳌µ ï쳌® ï쳌¥ ï쳌° / ï쳌£ ï쳌¢ ï쳌¤ / ï쳌£ ï쳌¯ ï쳌° / ï?? / ï?? ï?? , is available at http : the text of the ï쳌£ ï쳌¢ ï쳌¤ . / / www.biodiv.org , as are other ï쳌£ ï쳌¢ ï쳌¤ documents referred to in the 17 text . Article ï?? ï?? includes three activities : collection , capture , and hunt - 4 ing ; it classifies purposes in economic , reproduction , restoration , The components of biological diversity that we use are , in a simple repopulation , reintroduction , translocation , and environmental interpretation , biological resources . For the complete definition education ( although the economic purposes are not defined ) . see ï쳌£ ï쳌¢ ï쳌¤ , Article ï?? . Within the objectives , biological resources are 18 differentiated from genetic resources . According to articles ï?? , ï?? and ï?? ï?? . 5 19 Adopted by Resolution ï?? / ï?? ï?? ï?? ï?? of the ï쳌¦ ï쳌¡ ï쳌¯ Conference on ï?? According to articles ï?? ï?? to ï?? ï?? . November ï?? ï?? ï?? ï?? . 20 Article ï?? ï?? ï?? of the Criminal Code . 6 The extent of such involvement is a contentious issue . It could be 21 The interpretation of the Mexican Institute of Industrial Property is argued that the degree of participation currently covered in the stated in the document responding to a consultation made by ï쳌£ ï쳌¯ ï쳌® ï쳌¡ - legislation is sufficient . However , some would like to see a stronger ï쳌¢ ï쳌© ï쳌¯ ( ï쳌¤ ï쳌¤ ï쳌¡ ï쳌ª . ï?? ï?? ï?? ï?? . ï?? ï?? ï?? , ï?? September ï?? ï?? ï?? ï?? ) . presence of the State in the ï쳌¡ ï쳌¢ ï쳌³ process . An example of this has 22 Isolation and description of gene sequences complicates the issue been found in the recent discussion regarding the Nordhausen further since some see them as an inventive step and some would initiative . still view them as insufficient steps . 7 See the web site of the group on Erosion Technology and 23 In ï?? ï?? ï?? ï?? , the Latin American ï쳌© ï쳌£ ï쳌¢ ï쳌§ suspended collecting activities in Concentration ( ï쳌¥ ï쳌´ ï쳌£ ) for further information . Mexico . Access to this project was granted under article ï?? ï?? of the ï?? The text of the Constitution and other legal references are ï쳌¥ ï쳌¥ ï쳌¥ ï쳌° ï쳌§ ï쳌¡ that authorizes the collection of organisms for scientific available at http : / / www.juridicas.unam.mx / infjur / and http : purposes . However , because of the commercial and biotechnologi - / / www.cddhcu.gob.mx . cal nature of the project , access should have been granted under 9 article ï?? ï?? ï쳌¢ ï쳌© ï쳌³ that regulates the collection of samples for biotechno - Latest amendment published in the Official Federal Gazette . logical purposes . When this contradiction became clear the project 10 In fact it is something different . This concept of eminent domain suspended activities and no collections have occurred in recent derives from the notion of sovereignty of a State over its territory years . and has traditionally rendered thus some confusion between the 24 The director of the Latin American ï쳌© ï쳌£ ï쳌¢ ï쳌§ in Mexico , Robert Bye , concepts of sovereignty and property ( T ï쳌¥ ï쳌® ï쳌¡ - R ï쳌¡ ï쳌­ ï쳌© ï쳌² ï쳌¥ ï쳌º ï?? ï?? ï?? ï?? ) . This presented , in the ï쳌¶ ï쳌© ï쳌© Latin American Botanical Congress in ï?? ï?? ï?? ï?? , also justifies the understanding that the ï쳌£ ï쳌¢ ï쳌¤ does not take any deci - a round table called â?? The Convention on Biological Diversity : sion on property rights . Opportunity or Limitation for the Use of Germplasm â?쳌 , reflecting 11 Municipios are the lower or primary category of state organiza - the sentiment of the complications that the new framework imposes tional authority in Mexico that reproduces the three branches of upon scientists . government , with some restrictions . 25 The applicable legislation states that the National Institute of 12 The San Andrés Agreements and the legal reform proposed by the Ecology ( ï쳌© ï쳌® ï쳌¥ ) has the authority to act , upon delegation of ï쳌³ ï쳌¥ ï쳌­ ï쳌¡ ï쳌² - Comisión de Concordia y Pacificación . ï쳌® ï쳌¡ ï쳌´ â?? s faculties , as representative of the Federation where Federal 13 According to article ï?? , subsection III . Land is involved . On the other hand , the applicable legislation 14 also stated ( bearing in mind that administrative regulations have There is a key difference regarding the relationship between the changed since then ) that the responsibility to issue authorizations ï쳌° ï쳌© ï쳌£ and the authorization . The ï쳌³ ï쳌¦ ï쳌¤ ï쳌§ ï쳌¡ requires having the ï쳌° ï쳌© ï쳌£ as a to use wild flora and fauna fell within ï쳌© ï쳌® ï쳌¥ faculties . prior condition to grant the authorization for both biotechnological 26 and scientific purposes . The ï쳌· ï쳌§ ï쳌¡ regulation on scientific collection For which ï쳌£ ï쳌¯ ï쳌® ï쳌¡ ï쳌¢ ï쳌© ï쳌¯ acts as trustee . This was envisioned as a means does not have that precedence requirement and the ï쳌¥ ï쳌¥ ï쳌¥ ï쳌° ï쳌§ ï쳌¡ only to exercise the right to benefit sharing by the owner of the land has the requirement for biotechnological purposes , but not for where the genetic resource is located . ï?? ï?? ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ 27 Signed by the National Association of Trading Enterprises of Rural sential part of the bioprospecting agreement which has an impact Producers , the National Union of Regional Autonomous Peasant upon the existence of a suitable recipient of possible technology Organizations , the National Association of Democratic Lawyers , transfers . the Group of Environmental Studies , Greenpeace Mexico , the 32 ï쳌¯ ï쳌­ ï쳌© ï쳌¥ ï쳌£ ï쳌¨ is the Organization of Indigenous Healers of the State of Studies Center for Change in Rural Mexico , the Permaculture Chiapas . Network ( Red de Permacultura ) , the Citizen Committee for the 33 ï쳌£ ï쳌¯ ï쳌­ ï쳌° ï쳌© ï쳌´ ï쳌£ ï쳌¨ is the Council of Indigenous and Traditional Medicine Defense of Mexicoâ??s Cultural and Natural Heritage , and four indi - Men and Parteros ( Birth supervisors ) of Chiapas . viduals belonging to research institutions . 34 ï쳌£ ï쳌¯ ï쳌­ ï쳌° ï쳌© ï쳌´ ï쳌£ ï쳌¨ currently markets a limited number of herbal remedies 28 This legal procedure , analogous to a suit , recognizes that protecting and nutritional supplements . the environment with societyâ??s participation requires the widening 35 of the concept of legal interest and extends it to any individual . For the Senate there are two relevant committees : the Committee 29 of Health , Social Security , Environment , Natural Resources , and As stated in the ï쳌£ ï쳌¢ ï쳌¤ , â?? biotechnology â?쳌 is any technological ap - Fishery and Committee of Legislative Studies . For the House of plication that uses biological systems and living organisms or their Representatives , it is the Committee of Rural Development . derivatives to create or modify production processes or for specific 36 uses . This includes a wide set of technologies , such as tissue cul - In the Senate on ï?? ï?? April ï?? ï?? ï?? ï?? . Available at ï쳌µ ï쳌² ï쳌¬ : http : / / ture , genetic engineering , and fermentations , among others . www.senado.gob.mx / gaceta / ï?? ï?? / index.html . In the House on ï?? ï?? 30 April ï?? ï?? ï?? ï?? . Available at ï쳌µ ï쳌² ï쳌¬ : http : / / camaradediputados.gob.mx / Sandoz - Pharma does not exist anymore as such ; in ï?? ï?? ï?? ï?? , it merged gaceta / . with Ciba to form Novartis . A couple of years later , the agriculture 37 branch of Novartis was sold to other firms in order to concentrate According to Decision ï?? , subsection d ) of the Cancun Declaration , their business in the pharmaceutical area . The ï쳌µ ï쳌º ï쳌¡ ï쳌£ ï쳌¨ ï쳌© - Sandoz con - issued by Ministers in charge of the Environment and Delegates tract ended in ï?? ï?? ï?? ï?? , almost at the same time that Sandoz merged from Brazil , China , Colombia , Costa Rica , Ecuador , India , with Ciba . Indonesia , Kenya , Mexico , Peru , South Africa , and Venezuela , who 31 The authority neglected proper consideration of the ï쳌© ï쳌¢ ï쳌´ as an es - convened in Cancun , Mexico , on ï?? ï?? February ï?? ï?? ï?? ï?? . ï?? ï?? ï?? 7 Philippines : Evolving Access and Benefit - Sharing Regulations Paz J . Benavidez II Biological and genetic resources are precious commodi - used in fisheries . There are ï?? , ï?? ï?? ï?? species of invertebrates ties which have long been accessed and exchanged by and ï?? , ï?? ï?? ï?? species of insects , of which ï?? , ï?? ï?? ï?? are endemic individuals and States , sometimes under government ( ï쳌° ï쳌¡ ï쳌· ï쳌¢ - ï쳌¤ ï쳌¥ ï쳌® ï쳌² ï?? ï?? ï?? ï?? ) . restrictions or regulations , and often â?? freely shared and In the Philippine coastal and marine ecosystems , there given â?쳌 . However , the continuous , unbridled utilization and are at least ï?? , ï?? ï?? ï?? species of marine plants and animals . exploitation of these resources , the rapid advances in sci - In terms of distribution among the ecosystems along the ence and technology , the economic value of potential cures Philippine coasts , coral reefs are the most diverse with and applications from these resources , and the inequitable ï?? , ï?? ï?? ï?? species . Next to these are seagrass beds with ï?? ï?? ï?? sharing of benefits derived from them have put increasing species . Its ï?? ï?? taxa of seagrasses make the Philippines pressure on resource - rich countries to rethink their policies the second highest in seagrass species in the world . The on access to and exchange of these resources . diversity of mangroves is also high , with ï?? ï?? ï?? species The Philippines is one of the richest countries in the ( ï쳌° ï쳌¡ ï쳌· ï쳌¢ - ï쳌¤ ï쳌¥ ï쳌® ï쳌² ï?? ï?? ï?? ï?? ) . world in terms of wildlife species . It is home to a very Studies show that there are ï?? , ï?? ï?? ï?? plant species im - impressive biological and genetic diversity and endemicity . portant to agriculture populations of domesticated exotic The plants in Philippine forests consist of at least ï?? ï?? , ï?? ï?? ï?? animal species . In ï?? ï?? ï?? ï?? these totaled ï?? , ï?? ï?? ï?? , ï?? ï?? ï?? cara - species which represent ï?? % of the worldâ??s flora . There are baos , ï?? , ï?? ï?? ï?? , ï?? ï?? ï?? cattle , ï?? ï?? ï?? , ï?? ï?? ï?? horses , ï?? , ï?? ï?? ï?? , ï?? ï?? ï?? hogs , ï?? ï?? ï?? species of Philippine terrestrial mammals ( ï?? ï?? ï?? or ï?? ï?? % ï?? , ï?? ï?? ï?? , ï?? ï?? ï?? goats , and ï?? ï?? , ï?? ï?? ï?? other domesticated exotic of which are endemic ) . About ï?? ï?? ï?? species of birds have animal species . The aggregate poultry population reached been found of which ï?? ï?? ï?? ( ï?? ï?? % ) are endemic . There are ï?? ï?? ï?? , ï?? ï?? ï?? , ï?? ï?? ï?? head ( ï쳌° ï쳌¡ ï쳌· ï쳌¢ - ï쳌¤ ï쳌¥ ï쳌® ï쳌² ï?? ï?? ï?? ï?? ) . ï?? ï?? amphibian species , ï?? ï?? % of which are endemic . Over The rate of biodiversity loss in the Philippines has been ï?? , ï?? ï?? ï?? species of mollusks , ï?? ï?? species of millipedes , ï?? ï?? rapid due to the high rate of population growth ; economic species of centipedes , and more than ï?? ï?? , ï?? ï?? ï?? insect species systems and policies that fail to put value on the environ - are found in the Philippines ( ï쳌° ï쳌¡ ï쳌· ï쳌¢ - ï쳌¤ ï쳌¥ ï쳌® ï쳌² ï?? ï?? ï?? ï?? ) . ment and its resources ; inequity in the ownership , manage - There are ï?? , ï?? ï?? ï?? species of flora and ï?? , ï?? ï?? ï?? species of ment , and flow of benefits from the use and conservation fauna in Philippine freshwaters , a record considered im - of biological resources ; deficiencies in knowledge and its pressive . Inventories are yet to be made on the ï?? ï?? lakes , applications ; and legal and institutional deficiencies and ï?? ï?? ï?? major rivers , four major swamps / marshes , and the constraints ( B ï쳌¡ ï쳌² ï쳌¢ ï쳌¥ ï쳌² and L ï쳌¡ V ï쳌© ï?± ï쳌¡ ï?? ï?? ï?? ï?? ) . Philippine for - many bays , estuaries , and mudflats of the country . From est cover has been reduced from more than ï?? ï?? % to less the FishBase ( ï?? ï?? ï?? ï?? ) data of the International Center for than ï?? ï?? % over a period of ï?? ï?? years ; only about ï?? % of the Living Aquatic Resources Management , the Philippines countryâ??s coral reefs remains in excellent condition ; ï?? ï?? to has a total of ï?? ï?? ï?? freshwater fish species . Of these ï?? ï?? ï?? are ï?? ï?? % of its seagrass beds have been lost in the last ï?? ï?? years ; reportedly threatened species , ï?? ï?? are endemic , while ï?? ï?? are and about ï?? ï?? % of its mangrove areas have been lost in the ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ 1 last ï?? ï?? years . About ï?? ï?? % of national parks is estimated the perpetual existence of all native plants and animals . to be no longer biologically important ( B ï쳌¡ ï쳌² ï쳌¢ ï쳌¥ ï쳌² and L ï쳌¡ The law recognizes that effective administration of these V ï쳌© ï?± ï쳌¡ ï?? ï?? ï?? ï?? ) . As of ï?? ï?? ï?? ï?? , ï?? ï?? species of birds and ï?? ï?? spe - areas is possible only through cooperation among national cies of terrestrial mammals are either extinct in the wild , government , local government , and concerned private or - critical , or endangered , and three species of reptiles and ganizations . The use and enjoyment of the same must be two species of amphibians are internationally recognized consistent with the principles of biological diversity and 2 as threatened ( D ï쳌¥ L ï쳌¥ ï쳌¯ ï쳌® ï?? ï?? ï?? ï?? ) . sustainable development . This increasing threat to biodiversity has led both the In ï?? ï?? ï?? ï?? , the Philippines ratified the Convention government and nongovernmental organizations ( ï쳌® ï쳌§ ï쳌¯ s ) to on Biological Diversity ( ï쳌£ ï쳌¢ ï쳌¤ ) . In response to the ï쳌£ ï쳌¢ ï쳌¤ , 3 seriously take up the challenge of conserving and protect - Executive Order No . ï?? ï?? ï?? ( ï쳌¥ ï쳌¯ ï?? ï?? ï?? ) was signed into law 4 ing biodiversity , developing these resources , and utilizing on ï?? ï?? May ï?? ï?? ï?? ï?? . Its implementing rules and regulations , them in a sustainable manner for the benefit of present and ï쳌¤ ï쳌¥ ï쳌® ï쳌² Administrative Order No . ï?? ï?? ( ï쳌¤ ï쳌¡ ï쳌¯ ï?? ï?? ) was issued on 5 future Filipinos . ï?? ï?? June ï?? ï?? ï?? ï?? . On ï?? ï?? July ï?? ï?? ï?? ï?? , the Philippine Legislature Pursuant to Executive Order No . ï?? ï?? ï?? , the Department enacted Republic Act No . ï?? ï?? ï?? ï?? , otherwise known as the of Environment and Natural Resources ( ï쳌¤ ï쳌¥ ï쳌® ï쳌² ) formulated â?? Wildlife Resources Conservation and Protection Act â?쳌 the Philippine Strategy for Sustainable Development ( hereafter Wildlife Act ) which provides for new measures which aims to balance economic growth and biodiver - relative to bioprospecting in the Philippines . sity conservation . In ï?? ï?? ï?? ï?? , the Philippine Council for This paper will discuss the legal regime for access to Sustainable Development ( ï쳌° ï쳌£ ï쳌³ ï쳌¤ ) was established with a and exchange of biological and genetic resources in the Sub - Committee on Biodiversity ( ï쳌° ï쳌¡ ï쳌· ï쳌¢ - ï쳌¤ ï쳌¥ ï쳌® ï쳌² ï?? ï?? ï?? ï?? ) . Philippines . It will analyze Philippine access regulations On ï?? June ï?? ï?? ï?? ï?? , Republic Act No . ï?? ï?? ï?? ï?? , otherwise in the context of the goals of the ï쳌£ ï쳌¢ ï쳌¤ , the standards set by known as the National Integrated Protected Areas System the Agreement on Trade - Related Aspects of Intellectual ( ï쳌® ï쳌© ï쳌° ï쳌¡ ï쳌³ ) Law , was enacted . It provides for the establish - Property Rights ( ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ ) and other relevant international ment and management of a comprehensive protected agreements , and the promises of the Wildlife Act as a area system encompassing areas that are habitats of rare relatively new access regulation and conclude with recom - and endangered species of plants and animals , biogeo - mendations for the enhancement of regulations for access graphic zones , and related ecosystems in order to secure to and exchange of biological and genetic resources . Pre - EO 247 Access Regulation Prior to ï?? ï?? ï?? ï?? , the National Museum of the Philippines a collaborating local research institution or university ; a was the primary government agency regulating collection complete set of voucher specimens was deposited at the of biological samples pursuant to Republic Act No . ï?? ï?? ï?? ï?? , Museum and collaborating local institution ; and a local as amended by Presidential Decree ï?? ï?? ï?? ( B ï쳌¡ ï쳌² ï쳌¢ ï쳌¥ ï쳌² and L ï쳌¡ counterpart had to accompany every field visit / collection . V ï쳌© ï?± ï쳌¡ ï?? ï?? ï?? ï?? ) . In ï?? ï?? ï?? ï?? , the Protected Areas and Wildlife It also contained a code of ethics for collectors of biologi - Bureau ( ï쳌° ï쳌¡ ï쳌· ï쳌¢ ) under the ï쳌¤ ï쳌¥ ï쳌® ï쳌² was given a bigger role cal specimens in the country . Other relevant provisions of in regulating collection activities . Requests for collection the ï쳌­ ï쳌¯ ï쳌¡ included : protection from wanton exploitation of involving endangered species of fauna became the respon - biological resources by limiting collections to the mini - sibility of ï쳌° ï쳌¡ ï쳌· ï쳌¢ . Collection of marine species was handled mum possible number ( ï쳌­ ï쳌¯ ï쳌¡ Subsection ï?? . ï?? a ) ; recognition by the Bureau of Fisheries and Aquatic Resources , while and respect for indigenous communities , including their requests for collection involving animals needed the ap - customs , traditions , and folk knowledge ( Subsection ï?? . ï?? b ) ; proval of the Bureau of Animal Industry . Plant collection participation of local counterparts in the collection and is within the mandate of the Bureau of Plant Industry . The sharing of authorship in publications arising from these National Museum , however , continued to be the â?? official activities ( M ï쳌¡ ï쳌¤ ï쳌µ ï쳌¬ ï쳌© ï쳌¤ ï?? ï?? ï?? ï?? ) . clearinghouse for all requests to collect biological speci - The ï쳌­ ï쳌¯ ï쳌¡ , however , proved to be inadequate in terms of mens â?쳌 ( B ï쳌¡ ï쳌² ï쳌¢ ï쳌¥ ï쳌² and L ï쳌¡ V ï쳌© ï?± ï쳌¡ ï?? ï?? ï?? ï?? ) . compliance with the provisions of the ï쳌£ ï쳌¢ ï쳌¤ , because it was In ï?? ï?? ï?? ï?? , a memorandum of agreement ( ï쳌­ ï쳌¯ ï쳌¡ ) was primarily an administrative coordination and permitting executed by various government agencies , which con - system and not a regulatory framework for bioprospect - tained the â?? Guidelines for the Collection of Biological ing . It is â?? not explicit in aspects such as equitable return of Specimens in the Philippines â?쳌 for both local and foreign benefits to the country and to the local community in case collectors of biological specimens , including materials a drug is developed from a local plant or animal , transfer of for bioprospecting . It aimed to provide restriction and technology , and protection of Intellectual Property Rights control mechanisms for the entry and exit of biological of the indigenous communities â?쳌 ( M ï쳌¡ ï쳌¤ ï쳌µ ï쳌¬ ï쳌© ï쳌¤ ï?? ï?? ï?? ï?? ) . Thus , specimens to prevent technical smuggling under the guise the bioprospecting agreement between the ï쳌µ ï쳌³ ï쳌¡ National 6 7 of educational , scientific , or research purposes . Among its Cancer Institute ( ï쳌® ï쳌£ ï쳌© ) and the National Museum only salient features were : approval of collection was obtained vaguely touched the issue of indigenous rights . Binding from the Director of the National Museum or the head of provisions for concrete compensation to communities and ï?? ï?? ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : P ï쳌¨ ï쳌© ï쳌¬ ï쳌© ï쳌° ï쳌° ï쳌© ï쳌® ï쳌¥ ï쳌³ for their active participation in the collecting activities ments . Academic groups were also consulted on the draft are lacking . The agreement was also inadequate regarding before it was submitted to the Department of Science provisions on compensation to the government ( B ï쳌¡ ï쳌² ï쳌¢ ï쳌¥ ï쳌² and Technology ( ï쳌¤ ï쳌¯ ï쳌³ ï쳌´ ) for further consultation meetings and L ï쳌¡ V ï쳌© ï?± ï쳌¡ ï?? ï?? ï?? ï?? ) . Nevertheless , immediate benefits with other sectoral groups including the Sub - Committee such as technology transfer , research collaboration , and on Biodiversity of the Committee on the Conservation and complete sample collections have been obtained by the Management of Resources for Development of the ï쳌° ï쳌£ ï쳌³ ï쳌¤ 8 country through this agreement . ( L ï쳌¡ V ï쳌© ï?± ï쳌¡ et al . ï?? ï?? ï?? ï?? ) . The level of participation in the In February ï?? ï?? ï?? ï?? , the Seventh Asian Symposium on development of ï쳌¥ ï쳌¯ ï?? ï?? ï?? was said to be unprecedented for an Medicinal Plants , Species and Other Natural Products executive order in the Philippines , which usually requires ( ï쳌¡ ï쳌³ ï쳌¯ ï쳌­ ï쳌° ï쳌³ ) , which was held in the Philippines , issued The only limited consultation . In this case , representatives of Manila Declaration concerning â?? The Ethical Utilization government , scientists , ï쳌® ï쳌§ ï쳌¯ s , community organizations , of Asian Biological Resources â?쳌 , together with the Code of and the business community were actively involved in Ethics for Foreign Collectors of Biological Samples and the drafting of ï쳌¥ ï쳌¯ ï?? ï?? ï?? through a number of consultative Contract Guidelines . ï쳌¡ ï쳌³ ï쳌¯ ï쳌­ ï쳌° ï쳌³ â?? was largely instrumental in meetings . â?? The process ensured that the capacity building heightening awareness amongAsian scientists on the issue priorities of scientists were addressed in the provisions on of bioprospecting â?쳌 ( L ï쳌¡ V ï쳌© ï?± ï쳌¡ et al . ï?? ï?? ï?? ï?? ) . benefit sharing , and that the interests of local communities After the Manila Declaration and the ï쳌£ ï쳌¢ ï쳌¤ , the Philippine were taken into account in the provisions on local prior Network for the Chemistry of Natural Products , with fund - informed consent ( ï쳌° ï쳌© ï쳌£ ) â?쳌 ( S ï쳌· ï쳌© ï쳌¤ ï쳌¥ ï쳌² ï쳌³ ï쳌« ï쳌¡ ï?? ï?? ï?? ï?? ) . ing support from the ï쳌µ ï쳌® ï쳌¥ ï쳌³ ï쳌£ ï쳌¯ Regional Network for the In ï?? ï?? ï?? ï?? , the implementing rules and regulations of ï쳌¥ ï쳌¯ Chemistry of Natural Products in Southeast Asia , took the ï?? ï?? ï?? were drafted by a small group composed of the legal initiative to draft the executive order . In October ï?? ï?? ï?? ï?? , staff of ï쳌¤ ï쳌¥ ï쳌® ï쳌² , ï쳌° ï쳌¡ ï쳌· ï쳌¢ , ï쳌¤ ï쳌¯ ï쳌³ ï쳌´ , and scientists . This draft was Atty.Antonio G.M . La Viña was commissioned to draft ï쳌¥ ï쳌¯ circulated for comment to the ï쳌° ï쳌£ ï쳌³ ï쳌¤ , scientific organizations , ï?? ï?? ï?? with input from members of the Philippine Network industry groups , and national pharmaceutical companies nationwide and representatives of key government depart - before its approval in June ï?? ï?? ï?? ï?? ( S ï쳌· ï쳌© ï쳌¤ ï쳌¥ ï쳌² ï쳌³ ï쳌« ï쳌¡ ï?? ï?? ï?? ï?? ) . Executive Order 247 ï쳌¥ ï쳌¯ ï?? ï?? ï?? was issued on the basis of the ï?? ï?? ï?? ï?? Philippine The basic State policy set out in ï쳌¥ ï쳌¯ ï?? ï?? ï?? is â?? to regulate the prospecting of biological and genetic resources to the Constitution and the ï쳌£ ï쳌¢ ï쳌¤ . Specifically , section ï?? ï?? , Article end that these resources are protected and conserved , are II of the ï?? ï?? ï?? ï?? Philippine Constitution vests in the State the developed and put to the sustainable use and benefit of the ultimate responsibility to preserve and protect the environ - national interest . Further , it shall promote the development ment . Section ï?? , Article XII of the Constitution provides of local capability in science and technology to achieve that plants and animals are owned by the State , and the 9 technological self - reliance in selected areas â?쳌 . disposition , development , and utilization thereof are under ï쳌¥ ï쳌¯ ï?? ï?? ï?? has four basic elements ( B ï쳌¡ ï쳌² ï쳌¢ ï쳌¥ ï쳌² and L ï쳌¡ V ï쳌© ï?± ï쳌¡ its full control and supervision . The ï쳌£ ï쳌¢ ï쳌¤ , on the other hand , ï?? ï?? ï?? ï?? ) : calls for member countries to take appropriate measures â?¢ A system of mandatory research agreements be - with the aim that countries providing genetic resources are tween the collectors and the government containing given access to and transfer of technology that uses those minimum terms concerning provision of informa - resources , on mutually agreed terms . tion and samples , technology cooperation , and It was the perceived urgency for a comprehensive benefit sharing ; regulatory framework for access to biological and genetic resources , along with the slow pace of congressional legis - â?¢ An interagency committee to consider , grant , moni - lation , which led policy makers to come up with an execu - tor and enforce compliance with research agree - tive order ( B ï쳌¡ ï쳌² ï쳌¢ ï쳌¥ ï쳌² and L ï쳌¡ V ï쳌© ï?± ï쳌¡ ï?? ï?? ï?? ï?? ) . Executive Orders ments , as well as to coordinate further institutional , are â?? acts of the President providing for rules of a general policy , and technology development ; or permanent character in implementation or execution â?¢ A requirement and minimum process standards for of constitutional or statutory powers â?쳌 ( A ï쳌§ ï쳌° ï쳌¡ ï쳌¬ ï쳌¯ ï?? ï?? ï?? ï?? ) . obtaining ï쳌° ï쳌© ï쳌£ from local and indigenous commu - Although a law passed by Congress is more permanent , nities where collection of materials is carried out ; may be broader in scope , and may appropriate funds and and impose penalties , it may take longer to enact , amend , or â?¢ Minimum requirements to conform with environ - repeal . On the other hand , an executive action is limited in mental protection laws and regulations . scope because it covers only matters delegated by Congress to the President under a particular law , the Constitution , Scope of Application or international conventions , but it is faster and easier to promulgate . It can also be modified immediately in case ï쳌¥ ï쳌¯ ï?? ï?? ï?? covers prospecting of all biological and genetic of serious flaws . resources , their by - products and derivatives , in the public ï?? ï?? ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ 10 domain , including natural growths in private lands , which d ) two representatives of the local scientific community is intended to be utilized by both foreign and local prospec - from the academy who must be experts in biodiversity , 11 tors . â?? Bioprospecting â?쳌 is defined as â?? the research , collec - biotechnology , genetics , natural products chemistry , tion , and utilization of biological and genetic resources , for or similar disciplines ; e ) a permanent representative of the purpose of applying the knowledge derived therefrom the Department of Health who is knowledgeable about â?쳌 12 for scientific and / or commercial purposes . Traditional pharmaceutical research and development with empha - 13 uses are excluded . This definition was severely criticized sis on medicinal plant / herbal pharmaceudynamics ; f ) a by the academic and scientific sectors for being too broad permanent representative of the Department of Foreign and vague . As defined in ï쳌¥ ï쳌¯ ï?? ï?? ï?? , bioprospecting refers Affairs who has to facilitate international linkage relative to all kinds of collection and sampling of biological and to bioprospecting ; g ) a permanent representative of the genetic resources which , for some sectors , was not really National Museum who has expertise on natural history the intention . This prompted policy makers to attempt and / or biodiversity ; h ) a representative from the ï쳌® ï쳌§ ï쳌¯ s ac - to clarify in ï쳌¤ ï쳌¡ ï쳌¯ ï?? ï?? the scope of ï쳌¥ ï쳌¯ ï?? ï?? ï?? by stating that tive in biodiversity protection ; and i ) a representative from the term refers only to â?? activities aimed at discovering , a Peopleâ??s Organization with membership consisting of 18 exploring , or using these resources for pharmaceutical de - indigenous cultural communities , indigenous peoples , 14 19 velopment , agricultural , and commercial applications â?쳌 . and / or their organizations . The members serve for three 20 The Inter - Agency Committee on Biological and Genetic years and a term may be renewed for another three years . Resources ( ï쳌© ï쳌¡ ï쳌£ ï쳌¢ ï쳌§ ï쳌² ) members agreed that research and col - Among the functions of the committee are : to process lection activities associated with pure conservation work , applications for research agreements and recommend biodiversity inventory , taxonomic studies , and the like shall their approval / denial ; to ensure strict compliance with not be processed under ï쳌¥ ï쳌¯ ï?? ï?? ï?? but should follow an exist - the agreements ; to determine the quantity of collection ; 15 ing permitting system . However , no further guidelines to ensure protection of the rights of indigenous peoples were issued and the ï쳌© ï쳌¡ ï쳌£ ï쳌¢ ï쳌§ ï쳌² will decide the matter on a ( ï쳌© ï쳌° s ) / indigenous cultural communities ( ï쳌© ï쳌£ ï쳌£ s ) where bio - 21 case - to - case basis . For example , collections of resources prospecting is undertaken . The ï쳌© ï쳌¡ ï쳌£ ï쳌¢ ï쳌§ ï쳌² meets at least made for taxonomic studies are generally excluded , but once every quarter , but the chairperson / co - chairperson if the study goes beyond studying the morphology of may call special meetings as she / he deems necessary . All 22 specimens , ï쳌¥ ï쳌¯ ï?? ï?? ï?? would apply depending on the meth - decisions must be by a majority of its members . The final ods being used by the researcher . Also , internal guidelines approval , however , rests with the head of the government were formulated to guide the Technical Secretariat ( ï쳌´ ï쳌³ ) in department that has jurisdiction over the resources and / or 23 processing applications . activity . It is not clear if ï쳌¥ ï쳌¯ ï?? ï?? ï?? covers ex situ collections and other domesticated resources because of the qualification Mandatory Research Agreements placed in the implementing rules and regulations that One conducts bioprospecting by applying for a research 16 it covers â?? only natural growths in private lands â?쳌 . The agreement with the ï쳌© ï쳌¡ ï쳌£ ï쳌¢ ï쳌§ ï쳌² . The research agreement implication of this provision is that such collections and may be an Academic Research Agreement ( ï쳌¡ ï쳌² ï쳌¡ ) or a resources are not covered by ï쳌¥ ï쳌¯ ï?? ï?? ï?? . It is interesting to Commercial Research Agreement ( ï쳌£ ï쳌² ï쳌¡ ) . note , however , that among the applications for research An ï쳌¡ ï쳌² ï쳌¡ covers research undertaken by duly recognized agreements pending before the ï쳌© ï쳌¡ ï쳌£ ï쳌¢ ï쳌§ ï쳌² , one involves col - Philippine universities and academic institutions , domes - lection of resources in the commercial plantations of the tic governmental entities , and intergovernmental entities 17 proponent . It appears , thus , that , though not stated in ï쳌¥ ï쳌¯ 24 and their affiliates intended primarily for academic and ï?? ï?? ï?? , the ï쳌© ï쳌¡ ï쳌£ ï쳌¢ ï쳌§ ï쳌² regulates all biological resources in the 25 scientific purposes . It may be comprehensive in scope country whether or not outside their natural environment , and cover as many areas as the applicant proposes to work domesticated or wild . 26 in . Local academic institutions and intergovernmental Although the introductory clause of ï쳌¥ ï쳌¯ ï?? ï?? ï?? mentions research agencies with an ï쳌¡ ï쳌² ï쳌¡ are given flexibility and traditional knowledge , nowhere in the text of the order has allowed to exercise self - regulation . Any local scientist / it been discussed . However , traditional knowledge of local 27 researcher who is an affiliate of any of these institutions and indigenous communities is very much linked with the with a valid ï쳌¡ ï쳌² ï쳌¡ is allowed to conduct research under the ï쳌° ï쳌© ï쳌£ of the communities where the resources are taken . aegis of the said ï쳌¡ ï쳌² ï쳌¡ . However , before conducting any actual bioprospecting activity in the site , the researcher Administrative Mechanism must secure the required ï쳌° ï쳌© ï쳌£ certificate . Compliance with The administrative body charged with implementing ï쳌¥ ï쳌¯ the requirements of the ï쳌¡ ï쳌² ï쳌¡ , including the ï쳌° ï쳌© ï쳌£ , is the re - 28 ï?? ï?? ï?? is the ï쳌© ï쳌¡ ï쳌£ ï쳌¢ ï쳌§ ï쳌² . Its membership consists of the follow - sponsibility of the institution . These institutions are also ing : a ) an Undersecretary of ï쳌¤ ï쳌¥ ï쳌® ï쳌² as chairperson ; b ) an mandated to enforce a Code of Conduct for researchers . Undersecretary of ï쳌¤ ï쳌¯ ï쳌³ ï쳌´ as co - chairperson ; c ) a permanent Failure by the principal to monitor compliance with the representative of the Department ofAgriculture , who must ï쳌¡ ï쳌² ï쳌¡ by their affiliates may result in the cancellation of the 29 be knowledgeable about biodiversity or biotechnology ; ï쳌¡ ï쳌² ï쳌¡ . An ï쳌¡ ï쳌² ï쳌¡ is valid for a period of five years , renewable ï?? ï?? ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : P ï쳌¨ ï쳌© ï쳌¬ ï쳌© ï쳌° ï쳌° ï쳌© ï쳌® ï쳌¥ ï쳌³ 30 upon recommendation of the ï쳌© ï쳌¡ ï쳌£ ï쳌¢ ï쳌§ ï쳌² . are given the opportunity to negotiate for benefits with the applicants.Although representatives of ï쳌© ï쳌¡ ï쳌£ ï쳌¢ ï쳌§ ï쳌² are present Research and / or collection intended , directly or indi - during negotiations for a ï쳌° ï쳌© ï쳌£ , the decision is left entirely rectly , for commercial use requires a ï쳌£ ï쳌² ï쳌¡ that is valid for to the community and its leaders . a period of three years , renewable for a period as may be 31 Where the prospecting of biological and genetic re - determined by the ï쳌© ï쳌¡ ï쳌£ ï쳌¢ ï쳌§ ï쳌² . Under ï쳌¥ ï쳌¯ ï?? ï?? ï?? , all research sources and the indigenous knowledge related to their use , agreements with private persons , including foreign inter - 40 preservation , and promotion is done in ancestral domain national entities , shall conform to the minimum require - 41 or ancestral land , the applicant must obtain the free and ments of a ï쳌£ ï쳌² ï쳌¡ even if the bioprospecting activity is purely 32 prior informed consent ( ï쳌¦ ï쳌° ï쳌© ï쳌£ ) of the ï쳌© ï쳌° s in accordance scientific . In addition to the bioprospecting fees , the col - 42 with their customary laws . In this case , ï쳌¦ ï쳌° ï쳌© ï쳌£ means the lector under a ï쳌£ ï쳌² ï쳌¡ is also required to pay a performance , consensus of all members of the ï쳌© ï쳌£ ï쳌£ s / ï쳌© ï쳌° s , arrived at through compensation , or ecological bond to be determined by 33 customary law , free from external manipulation or interfer - the ï쳌© ï쳌¡ ï쳌£ ï쳌¢ ï쳌§ ï쳌² . 34 ence . The process should involve disclosure of intention Since ï?? ï?? ï?? ï?? , the ï쳌© ï쳌¡ ï쳌£ ï쳌¢ ï쳌§ ï쳌² has processed eight applica - 35 36 and extent of the activity in a transparent manner and in tions for ï쳌£ ï쳌² ï쳌¡ and ï?? ï?? for ï쳌¡ ï쳌² ï쳌¡ . Only one ï쳌£ ï쳌² ï쳌¡ and one 43 37 understandable language . ï쳌¡ ï쳌² ï쳌¡ have been approved so far ( Boxes ï?? and ï?? ) . Under ï쳌¥ ï쳌¯ ï?? ï?? ï?? , the process for securing a ï쳌° ï쳌© ï쳌£ certificate shall be as follows : Application Process â?¢ Submit copies of the research proposal to the recog - ï쳌¥ ï쳌¯ ï?? ï?? ï?? requires the applicant to satisfy certain require - nized head of the ï쳌© ï쳌° , City or Municipal Mayor of the ments and to undergo an application process . ï쳌¥ ï쳌¯ ï?? ï?? ï?? does local government unit , ï쳌° ï쳌¡ ï쳌­ ï쳌¢ , or private landowner not provide for a specific time within which to process 44 concerned . applications . It is estimated to be at least five months . â?¢ Inform the local community , ï쳌© ï쳌° , ï쳌° ï쳌¡ ï쳌­ ï쳌¢ , or the private However , the process takes longer because the ï쳌© ï쳌¡ ï쳌£ ï쳌¢ ï쳌§ ï쳌² is landowner concerned of the intention to conduct required to meet only quarterly , although the chair can bioprospecting activity within the area through call for special meetings . It is also difficult to secure a various media advertisements or direct commu - common schedule for ï쳌© ï쳌¡ ï쳌£ ï쳌¢ ï쳌§ ï쳌² meetings . Also , the process nication . is often stalled because the applicant cannot immediately 45 â?¢ Post a notice in a conspicuous place one week submit the ï쳌° ï쳌© ï쳌£ . Under ï쳌¥ ï쳌¯ ï?? ï?? ï?? , action on the ï쳌° ï쳌© ï쳌£ can only prior to the holding of a community assembly . be taken after the lapse of ï?? ï?? days from the submission 46 of a research proposal to the community ( Box ï?? ) . This â?¢ Hold community consultation . ï?? ï?? - day requirement has been removed in the Wildlife Act , â?¢ Recognized head of the ï쳌© ï쳌° , Municipal or City and the law provides that action on the proposal shall be Mayor , ï쳌° ï쳌¡ ï쳌­ ï쳌¢ , or private landowner issues cer - made within a reasonable period from submission of all tificate upon determination that applicant has requirements . undergone the process required by law , but only Considering the varying nature of the ï쳌¡ ï쳌² ï쳌¡ and ï쳌£ ï쳌² ï쳌¡ , after the lapse of ï?? ï?? days from submission of the certain distinctions are incorporated in the application proposal . process corresponding to the characteristics of the ï쳌¡ ï쳌² ï쳌¡ or â?¢ Submit ï쳌° ï쳌© ï쳌£ certificate to the ï쳌© ï쳌¡ ï쳌£ ï쳌¢ ï쳌§ ï쳌² together with ï쳌£ ï쳌² ï쳌¡ ( Table ï?? ) . A new application procedure , however , is proofs of compliance with the ï쳌° ï쳌© ï쳌£ process . being drafted and will be enforced upon the approval of the implementing rules and regulations of the Wildlife Act . Subsequent recanting by the community of the ï쳌° ï쳌© ï쳌£ shall not cause rescission of the agreement . However , if Prior Informed Consent it was obtained through fraud , stealth , false promises , or intimidation , or if the continuance of the agreement shall Pursuant to Article ï?? ï?? of the ï쳌£ ï쳌¢ ï쳌¤ , ï쳌¥ ï쳌¯ ï?? ï?? ï?? mandates that impair the rights of the ï쳌© ï쳌° s to the traditional uses of the prospecting , under either an ï쳌¡ ï쳌² ï쳌¡ or a ï쳌£ ï쳌² ï쳌¡ , can be allowed resources , the research agreement may be rescinded . only upon the prior informed consent of the community 38 from which the resources are taken . Unlike the ï쳌£ ï쳌¢ ï쳌¤ , the Minimum Terms and Conditions of concept of ï쳌° ï쳌© ï쳌£ under ï쳌¥ ï쳌¯ ï?? ï?? ï?? refers not only to the consent Research Agreements of the State but extends to the ï쳌© ï쳌° s , the local community , the Protected Area Management Board ( ï쳌° ï쳌¡ ï쳌­ ï쳌¢ ) , and the land - The following terms and conditions are incorporated in owner concerned . ï쳌° ï쳌© ï쳌£ is defined as â?? the consent obtained by the ï쳌£ ï쳌² ï쳌¡ and ï쳌¡ ï쳌² ï쳌¡ : the applicant from the local community , indigenous people , the ï쳌° ï쳌¡ ï쳌­ ï쳌¢ , or private land owner concerned , after disclosing Ownership , Transfer , and Use of Materials . fully the intent and scope of the bioprospecting activity , in The research agreement states that ownership of materials 48 a language and process understandable to the community , used and / or taken remains with the State and complete 39 and before any bioprospecting activity is undertaken â?쳌 . It access to specimens deposited abroad shall be allowed 49 is through the ï쳌° ï쳌© ï쳌£ process that ï쳌© ï쳌° s and local communities to all Filipino citizens and the government . A report of ï?? ï?? ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ collections made , listing all depositories that have used or a ï쳌£ ï쳌² ï쳌¡ , a donation must be made by the principal of some are currently using Philippine species and their database of the equipment used in the conduct of the research to the and information , shall be submitted to the ï쳌© ï쳌¡ ï쳌£ ï쳌¢ ï쳌§ ï쳌² by the Philippine government agency , institutions , or universities 50 55 principal . Transport of materials shall be subject to exist - concerned . ing laws , rules and regulations , treaties , and international 51 Subsequent Transfers conventions . For ï쳌£ ï쳌² ï쳌¡ , the researcher shall collect only the Where the collector is merely an agent , the agreement kind and quantity of resources originally listed in the agree - 52 between the collector and the principal must be reviewed ment and only within the designated collection sites . 56 by the ï쳌© ï쳌¡ ï쳌£ ï쳌¢ ï쳌§ ï쳌² . A Material Transfer Agreement ( ï쳌­ ï쳌´ ï쳌¡ ) Terms of Collaboration shall accompany every transfer for the purpose of retaining Transfer of technology is encouraged by requiring com - 57 control over materials . pliance with certain conditions , namely : a complete set of voucher specimens for the collected material must be Prior Informed Consent of Communities deposited at the National Museum or duly designated de - No bioprospecting activity shall be conducted without the pository ; holotypes must be labeled properly and retained prior informed consent of the local community , ï쳌° ï쳌¡ ï쳌­ ï쳌¢ , and at the National Museum ; a complete set of all living speci - the landowner concerned and the free and prior informed mens collected must be deposited in mutually agreed and consent of ï쳌© ï쳌° s . 53 duly designated depositories ; there must be collaboration Environmental Protection with a Philippine scientist in all bioprospecting research by ï쳌¥ ï쳌¯ ï?? ï?? ï?? provides that bioprospecting activities and their foreign persons , including technological development of 54 a product derived from the collected resources ; and , for results must not directly or indirectly harm the biologi - Box 1 . Commercial Research Agreement applications ( Information provided by the Technical Secretariat ) Applicant Research title / Activity Date Status Remarks Dr . Gerard L . Penecilla â?? Collaborative Exploitation of Phyto - ï?? ï?? / ï?? ï?? / ï?? ï?? Application was Biological Sciences withdrawn . chemical Resources â?쳌 : This will involve Dept . , West Visayas collection of ï?? ï?? ï?? species of flowering State University , Iloilo plants and bryophytes for purposes of : City a ) bioassay of medicinal plants with Collaborator : Univ . of anti - cancer potential and other pharma - Ghent , Belgium ceutical properties , and b ) bioprospect - ing of different plant species for pharmaceutical , pesticidal and other industrial purposes . Philippine National â?? Investigations of Marine Species ï?? ï?? / ï?? ï?? / ï?? ï?? Gratuitous Permit Documents for ï쳌£ ï쳌² ï쳌¡ Museum , Department No . ï?? ï?? - ï?? ï?? issued application referred to Diversity of the Philippines and the of Agriculture ( ï쳌¤ ï쳌¡ ) , by ï쳌¢ ï쳌¦ ï쳌¡ ï쳌² expired ï쳌¢ ï쳌¦ ï쳌¡ ï쳌² to draft the ï쳌£ ï쳌² ï쳌¡ . Search for New Anti - cancer Drugs Bureau of Fisheries on ï?? ï?? / ï?? ï?? / ï?? ï?? . from the Sea â?쳌 : This will involve and Aquatic Resources collection of marine invertebrates and ( ï쳌¢ ï쳌¦ ï쳌¡ ï쳌² ) , National marine plant samples with potential Cancer Institute , cancer and anti - ï쳌¡ ï쳌© ï쳌¤ ï쳌³ activity for and the Coral Reef extraction and isolation by the ï쳌µ ï쳌³ ï쳌¡ Research Foundation National Cancer Institute of Marine Natural Products . University of â?? Research on Marine Organisms as ï?? ï?? / ï?? ï?? / ï?? ï?? Documents were referred to ï쳌¢ ï쳌¦ ï쳌¡ ï쳌² . California - Silliman Possible Sources of Novel Natural University Products Including New Drugs c / o William Fenical Projects â?쳌 ï쳌µ ï쳌° Marine Science â?? Anti - Cancer Agents from Unique ï?? ï?? / ï?? ï?? / ï?? ï?? Approved / signed Collection report Institute - Utah on ï?? ï?? / ï?? ï?? / ï?? ï?? by submitted to ï쳌° ï쳌¡ ï쳌· ï쳌¢ on Natural Products Sources â?쳌 : This University , ï쳌µ ï쳌³ ï쳌¡ ï쳌¤ ï쳌¡ Secretary ï?? ï?? / ï?? ï?? / ï?? ï?? . Project will involve collection Salvador of funicates , sponges and other Escudero III . invertebrate samples for biological assays to screen for potential bioactive compounds . ï?? ï?? ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : P ï쳌¨ ï쳌© ï쳌¬ ï쳌© ï쳌° ï쳌° ï쳌© ï쳌® ï쳌¥ ï쳌³ cal diversity , ecological balance , or the inhabitants of the be equitably shared with either of the following parties : area where collection is undertaken . Also , collection un - a ) the Philippine government , b ) the Integrated Protected der a research agreement must comply with all applicable Areas Fund ( ï쳌© ï쳌° ï쳌¡ ï쳌¦ ) , c ) the concerned ï쳌© ï쳌° s or local communi - environmental laws , regulations , and procedures such as ties , or d ) the individual who modified such resource that 62 the Environmental Impact Assessment Law and the ï쳌® ï쳌© ï쳌° ï쳌¡ ï쳌³ came from private property . A separate agreement shall 58 Act . be made for the transfer of royalty , benefits , technology , 63 and agreements . Benefit Sharing ï쳌¥ ï쳌¯ ï?? ï?? ï?? provides for minimum benefit - sharing arrange - Penalties and Sanctions ments that must be met by the bioprospector . It mandates that all discoveries of commercial products derived from As an executive issuance , ï쳌¥ ï쳌¯ ï?? ï?? ï?? does not provide for penal the resources shall be made available to the Philippine sanctions against violators of the law . However , activities 59 government and the local community concerned . undertaken without the required research agreement and Likewise , all benefits resulting directly or indirectly from ï쳌° ï쳌© ï쳌£ certificate shall be subject to criminal prosecution un - 64 the bioprospecting activities conducted shall be shared der relevant statutes such as the ï쳌® ï쳌© ï쳌° ï쳌¡ ï쳌³ Act . Also , adminis - equitably and upon mutual consent among the government , trative sanctions are imposed , such as immediate termina - 60 the communities concerned , and the principal . The use of tion of the agreement and a perpetual ban on undertaking technologies , commercially or locally , developed from re - prospecting in the Philippines in cases of noncompliance 65 search on Philippine endemic species must be made avail - with the provisions of the research agreement . able to the Philippine government without paying royalty to the principal unless other agreements may be negotiated Implementation and Monitoring 61 by the parties , where appropriate and applicable . Under The respective member agencies of the ï쳌© ï쳌¡ ï쳌£ ï쳌¢ ï쳌§ ï쳌² shall a ï쳌£ ï쳌² ï쳌¡ , regarding technology or a commercial product conduct monitoring of research agreements based on a developed and marketed any equity or remittance , in the amount to be mutually agreed upon by the parties , shall standard monitoring scheme to be devised by the ï쳌© ï쳌¡ ï쳌£ ï쳌¢ ï쳌§ ï쳌² Box 1 . Continued Applicant Research title / Activity Date Status Remarks Mr . Tim M.A . â?? Systematics of the Genus Maesa ï?? ï?? / ï?? ï?? / ï?? ï?? Pending . Awaiting submission of ( Myrsinaceae ) in the Philippines â?쳌 necessary documents , Utteridge , Department e.g . , ï쳌° ï쳌© ï쳌£ . of Ecology and Biodiversity , The University of Hong Kong , Pokfulam Road , Hong Kong Dr . Lourdes J . Cruz , â?? Neuroactive Peptides from Venomous ï?? ï?? / ï?? ï?? / ï?? ï?? Submitted on ï?? ï?? March Pending . Marine Science Gastropods â?쳌 : This project aims to ï?? ï?? ï?? ï?? original and Institute University make use of animals that would notarized copies of the of the Philippines , otherwise be discarded by the shell ï쳌° ï쳌© ï쳌£ certificates issued by Diliman , Quezon City craft industry . Selected gastropods Mun . Mayor of Mabini , ( Conus and related groups of turrids Batangas and other and terribrids ) will be studied . documents required under ï쳌¤ ï쳌¡ ï쳌¯ ï?? ï?? - ï?? ï?? and by the ï쳌© ï쳌¡ ï쳌£ ï쳌¢ ï쳌§ ï쳌² not yet received . Kagoshima University â?? Man and the Environment in Palawan , ï?? ï?? / ï?? ï?? Application was Research Center for withdrawn . Philippines â?쳌 : Aims to conduct research the South Pacific expedition and collection of biological Kagoshima , Japan specimens in Palawan . Rizal Technological â?? Development / Establishment of Center ï?? ï?? / ï?? ï?? / ï?? ï?? Forwarded letter dated Colleges c / o José ï?? ï?? / ï?? ï?? / ï?? ï?? requesting for the Conservation of Philippine Macabbalug documents for the ï쳌£ ï쳌² ï쳌¡ Native Orchids â?쳌 : Establishment of application . No response in - vitro culture bank for research , yet . production , and commercialization of Philippine orchids . ï?? ï?? ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ 66 for that purpose . There shall be an ï쳌© ï쳌¡ ï쳌£ ï쳌¢ ï쳌§ ï쳌² monitoring Issues and Concerns team responsible for establishing a mechanism to ensure Since the issuance of ï쳌¥ ï쳌¯ ï?? ï?? ï?? in ï?? ï?? ï?? ï?? , several issues have the integration and dissemination of the information gener - been brought up which , in a way , affected the full imple - 67 ated from research , collection , and utilization activities . mentation of the law . The issues and concerns that have Another monitoring team headed by ï쳌¤ ï쳌¯ ï쳌³ ï쳌´ and Department confronted ï쳌¥ ï쳌¯ ï?? ï?? ï?? are as follows : of ForeignAffairs representatives monitors the progress of ï?? ï?? Scope and Coverage the research , utilization , and commercialization outside the 70 68 Two relevant points were raised at the workshops held country . A draft guideline on monitoring is now under review by the ï쳌© ï쳌¡ ï쳌£ ï쳌¢ ï쳌§ ï쳌² . in ï?? ï?? ï?? ï?? : Box 2 . Academic Research Agreement applications ( Information provided by the Technical Secretariat ) Applicant Research title / Activity Date Description Status ï쳌µ ï쳌° System ï?? ï?? / ï?? ï?? / ï?? ï?? Conservation - related re - Approved search , including studies as part of thesis requirements . International Rice ï?? ï?? / ï?? ï?? / ï?? ï?? Conduct scientific research For further Research Institute evaluation / review on rice varieties and wild c / o Ronald Cantrell by the TS and species , rice - associated vege - and Dr . Mew ï쳌© ï쳌¡ ï쳌£ ï쳌¢ ï쳌§ ï쳌² . tation , fauna , and microor - ganisms . Research Institute Development of an immunodot ï?? ï?? / ï?? ï?? / ï?? ï?? Collection of snails â?? urine Recommended for Tropical dipstick for the detection of circulating samples for S . japonicum an - for ï쳌¡ ï쳌² ï쳌¡ between Medicine ( ï쳌² ï쳌© ï쳌´ ï쳌­ ) Schistosoma japonicum antigens tigen production . Evaluation ï쳌¤ ï쳌¥ ï쳌® ï쳌² and ï쳌² ï쳌© ï쳌´ ï쳌­ . c / o Dr . R.M . in the urine using locally produced of test assay . Additional Olveda monocional antibodies . requirements / information sub - mitted to ï쳌° ï쳌¡ ï쳌· ï쳌¢ ï?? August ï?? ï?? ï?? ï?? . â?? " â?? S . japonicum reinfection after â?? " â?? Collection of snails and â?? " â?? treatment in domestic animals and stools , blood , and urine of impact of animal chemotherapy on animals and human to moni - transmission . tor S . japonicum infection in animals and man before and after treatment . â?? " â?? Biased short - term surveillance for Bat â?? " â?? Collection of blood and brain â?? " â?? Lyssavirus . samples from species of bats to determine the presence of virus variants in bat popula - tions . â?? " â?? Molecular epidemiology of canine â?? " â?? Collection of dog brain â?? " â?? rabies in the Philippines . samples to describe the epidemiology of canine rabies virus variants . â?? " â?? Expanded surveillance of Ebola Reston â?? " â?? Collection of blood , liver â?? " â?? Virus in the Philippines : Investigation and other tissue samples of possible natural hosts . from monkeys to describe the epidemiology of Ebola Reston Virus in indigenous macaque populations . â?? " â?? Epidemiologic survey of Hantavirus â?? " â?? Collection of urban & rice â?? " â?? infection among rodent populations in field rats ( Rattus spp . ) to the Philippines . determine the presence of extent of transmission of Hantivirus infection . ï?? ï?? ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : P ï쳌¨ ï쳌© ï쳌¬ ï쳌© ï쳌° ï쳌° ï쳌© ï쳌® ï쳌¥ ï쳌³ discourages all kinds of research in the country . â?¢ The scope of ï쳌¥ ï쳌¯ ï?? ï?? ï?? is too broad due mainly to a vague definition of the term â?? bioprospecting â?쳌 . The â?¢ ï쳌¥ ï쳌¯ ï?? ï?? ï?? is ambiguous as far as ex situ collections are term â?? prospecting â?쳌 means to explore or to look for , concerned , but the ï쳌© ï쳌¡ ï쳌£ ï쳌¢ ï쳌§ ï쳌² regulates them . ï쳌¤ ï쳌¡ ï쳌¯ ï?? ï?? but ï쳌¥ ï쳌¯ ï?? ï?? ï?? covers not only just â?? looking for â?쳌 . The further muddles the issue by explicitly stating that law regulates the act of collecting and sampling . only natural growths in private lands are covered by As such , the definition appears to cover almost all the law , thus implying that domesticated resources kinds of collection , research , and utilization of are not regulated . This ambiguity may be used to biological and genetic resources , including con - circumvent the law . Similarly , some people are not servation research that many scientists , academic comfortable with the exclusion of traditional uses institutions , and ï쳌® ï쳌§ ï쳌¯ s undertake and which have from the lawâ??s coverage . There is apprehension that nothing to do with prospecting . This stifles and bioprospectors can simply obtain resources from Box 2 . Continued Applicant Research title / Activity Date Description Status ï쳌² ï쳌© ï쳌´ ï쳌­ continued Specimen banking for future reference ï?? ï?? / ï?? ï?? / ï?? ï?? Collection of monkey and rat Recommended of other unknown or emerging specimens for identification for ï쳌¡ ï쳌² ï쳌¡ between zoonotic pathogens . of other possible emerg - ï쳌¤ ï쳌¥ ï쳌® ï쳌² and ï쳌² ï쳌© ï쳌´ ï쳌­ . ing zoonotic diseases from Additional primates and rodents . requirements / information sub - mitted to ï쳌° ï쳌¡ ï쳌· ï쳌¢ ï?? August ï?? ï?? ï?? ï?? . â?? " â?? Agusan del Sur Malaria Control â?? " â?? Collection of mosquito adults â?? " â?? Program . and larvae to identify the vec - tor breeding sites , to deter - mine peak biting time , to test susceptibility to insecticides . â?? " â?? Application of radio nuclide technique â?? " â?? Collection of mosquitoes to â?? " â?? in the detection of Wuchereria detect W . bancrofti infection bancrofti infected mosquitoes for in mosquitoes . assessing filarial transmission . Aurora State Aurora Biodiversity Assessment ï?? ï?? / ï?? ï?? Collection of certain species Recommended College of Conservation Program . for ï쳌¡ ï쳌² ï쳌¡ by ï쳌´ ï쳌³ of birds , mammals and Technology during the plants to assess biodiversity ï?? ï?? / ï?? ï?? / ï?? ï?? meeting . resources of Aurora , and establish a database and knowledge - base for its conservation . Emilio Aguinaldo Destructiveness and Potential to ï?? ï?? / ï?? ï?? / ï?? ï?? Collection of both male and College c / o Dr . Transmit Microbial Diseases by female insects to determine Cecilia P . Reyes Scirtothrips dorsalin . the degree of destructiveness of adults on larval instars of S . dorsalis , and to determine the role of adults and larval instars of S . dorsalis in transmitting microbial diseases . â?? " â?? Identification of insect scavengers â?? " â?? Collection of 0.5 kg of and their potential as biological agent garbage for arthropod of reclamation and management of extraction to identify organic household garbage . different species on insect scavengers associated with household garbage , and to determine the preference & rate of consumption of garbage by insect scavengers . ï?? ï?? ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ 71 public markets or gather them under the guise of For a ï쳌£ ï쳌² ï쳌¡ , the collector also posts a bond . However , it is the cost of securing the ï쳌° ï쳌© ï쳌£ certificate that is the source of traditional use . most complaints . For example , if the research would re - Application Process quire utilization or collection of resources from ï?? ï?? regions The period from filing of the application to final approval of of the Philippines , the collector will have to go to ï?? ï?? sites the agreement is estimated to require at least five months . to secure ï?? ï?? ï쳌° ï쳌© ï쳌£ / ï쳌¦ ï쳌° ï쳌© ï쳌£ certificates . Each community will For most local scientists and researchers , the process is have different demands , terms , and conditions that must cumbersome , costly , and considered a deterrent to research be complied with . Also , because negotiations for ï쳌° ï쳌© ï쳌£ are growth and development ( ï쳌¥ ï쳌¯ ï?? ï?? ï?? W ï쳌¯ ï쳌² ï쳌« ï쳌³ ï쳌¨ ï쳌¯ ï쳌° ï?? ï?? ï?? ï?? ) . left entirely to the community and the applicant , collectors At the initial stage of the application process , the re - are worried that communities , ï쳌© ï쳌° s , politicians , and others searcher is required to pay a minimal amount of ï?? ï?? , ï?? ï?? ï?? P who must give consent will hold the bioprospector and for Filipinos or ï?? ï?? , ï?? ï?? ï?? P for foreign nationals as an applica - the activity hostage by asking outrageous and excessive tion fee . As soon as the research agreement is approved , a demands ( ï쳌¥ ï쳌¯ ï?? ï?? ï?? W ï쳌¯ ï쳌² ï쳌« ï쳌³ ï쳌¨ ï쳌¯ ï쳌° ï?? ï?? ï?? ï?? ) . Because of the dire bioprospecting fee is remitted to the national government . Box 2 . Continued Applicant Research title / Activity Date Description Status Pamantasan ï?? ï?? / ï?? ï?? / ï?? ï?? Conduct of conservation - The ï쳌° ï쳌¬ ï쳌­ had been ng Lungsod ng related studies as part of requested to sub - Maynila ( ï쳌° ï쳌¬ ï쳌­ ) thesis requirements , etc . mit the require - ments for î?? î?« î?? ; The Gratuitous Permit for the studies to be con - ducted by the ï쳌° ï쳌¬ ï쳌­ students for thesis requirements will be prepared by ï쳌° ï쳌¡ ï쳌· ï쳌¢ . Central Mindanao Diversity of Vascular Plants in Mt . Recommended University c / o Prof . Kinasalapi , Kitanglad Range Natural for ï쳌¡ ï쳌² ï쳌¡ by the ï쳌´ ï쳌³ Joel Almeror Park . during the ï?? ï?? / ï?? ï?? / ï?? ï?? meeting . Central Mindanao Institute for Terrestrial Biodiversity ï?? ï?? / ï?? ï?? / ï?? ï?? Collection of endemic / Submitted in University c / o Mr . and Conservation Studies in Mindanao . endangered flora and fauna ï?? ï?? / ï?? ï?? copies of Jaime Gellor in Mindanao for research and the research pro - instruction purposes . posals on the on - going , as well as future studies to ï쳌° ï쳌¡ ï쳌· ï쳌¢ for ï쳌´ ï쳌³ and ï쳌© ï쳌¡ ï쳌£ ï쳌¢ ï쳌§ ï쳌² review . New Samar Scientific Study for the Protection and Experimental gathering Referred to ï쳌¢ ï쳌¦ ï쳌¡ ï쳌² . Aquatic Resources Preservation of Corals . of precious corals in the Development Corp . Philippines waters through the use of î?? î?? î?? î?° î?¸ î?¡ manned vehicle . After one year , the development of processing plant . Miami University An investigation of plant utilization Collection of plants in pursuit Requested to c / o Alycia ( medicinal and home gardens ) on the of masterâ??s thesis . submit the Baybayan island of Igbayat , Batanes . requirements for ï쳌£ ï쳌² ï쳌¡ between ï쳌¤ ï쳌¥ ï쳌® ï쳌² and Miami University . Central Luzon Institutional research . Requested to sub - State Univ . c / o mit the require - Annie Paz - Alberto ments for ï쳌¡ ï쳌² ï쳌¡ . ï?? ï?? ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : P ï쳌¨ ï쳌© ï쳌¬ ï쳌© ï쳌° ï쳌° ï쳌© ï쳌® ï쳌¥ ï쳌³ economic situation , ï쳌¥ ï쳌¯ ï?? ï?? ï?? is seen as the solution to the tion ( ï쳌¥ ï쳌¯ ï?? ï?? ï?? W ï쳌¯ ï쳌² ï쳌« ï쳌³ ï쳌¨ ï쳌¯ ï쳌° ï?? ï?? ï?? ï?? ) . communities â?? socio - economic difficulties , leading them Nevertheless , many still believe that the ï쳌° ï쳌© ï쳌£ require - to focus on short - term and immediate benefits ( P ï쳌¥ ï쳌² ï쳌© ï쳌¡ ment should not be discarded because it is the only means ï?? ï?? ï?? ï?? ) . Local scientists and researchers who normally for the inclusion of the communities â?? concerns in the re - rely only on financial grants consider this unreasonable , search agreement . Also , it is the only opportunity for the and the economic costs involved stifle their research . This community to negotiate equitable sharing of benefits with is especially true for scientists who are not affiliated with the proponent . The process for securing the ï쳌° ï쳌© ï쳌£ , however , any Philippine scientific , academic , governmental , or should be properly studied ( P ï쳌¥ ï쳌² ï쳌© ï쳌¡ ï?? ï?? ï?? ï?? ) . intergovermental institution which would only have to comply with the minimum terms and conditions of a ï쳌£ ï쳌² ï쳌¡ Institutional Mechanism under ï쳌¥ ï쳌¯ ï?? ï?? ï?? . An interagency body consisting of representatives of various agencies of the government and other sectors is Prior Informed Consent advantageous because of the multidisciplinary nature of the The ï쳌° ï쳌© ï쳌£ requirement under ï쳌¥ ï쳌¯ ï?? ï?? ï?? is seen as adminis - issues relating to bioprospecting . Expertise and logistics tratively tedious and burdensome , especially the ï?? ï?? - day are shared . However , an interagency approach has many period requirement before ï쳌° ï쳌© ï쳌£ is issued . As earlier stated , inherent problems as well . It is difficult to get a quorum most collectors also dread the ï쳌° ï쳌© ï쳌£ requirement due to of the members ; resolution or decision - making takes a economic costs . Identifying which community should long time because of irregular attendance of members ; and give consent is often problematic , especially in the case coordination between member agencies is difficult . Also , of pelagic or migratory species . responsibilities of the member agencies are not clearly Another issue raised concerning ï쳌° ï쳌© ï쳌£ deals with full delineated in ï쳌¥ ï쳌¯ ï?? ï?? ï?? ( ï쳌¥ ï쳌¯ ï?? ï?? ï?? W ï쳌¯ ï쳌² ï쳌« ï쳌³ ï쳌¨ ï쳌¯ ï쳌° ï?? ï?? ï?? ï?? ) . Funding disclosure of the intended activity and its impact on intel - requirements have always haunted the implementers of ï쳌¥ ï쳌¯ lectual property rights ( T ï쳌¡ ï쳌® ï쳌´ ï쳌© ï쳌¡ ï?? ï?? ï?? ï?? ) . There are some ï?? ï?? ï?? because there is no specific source of funds provided , who propose that disclosure should be limited to collection except from the savings of the concerned government agen - activity only rather than the entire process , so as not to prejudice patent rights and the confidentiality of informa - cies and the fees collected by the ï쳌© ï쳌¡ ï쳌£ ï쳌¢ ï쳌§ ï쳌² . Box 2 . Continued Applicant Research title / Activity Date Description Status Municipal Govern - Proposed Community - based ï?? ï?? / ï?? ï?? / ï?? ï?? A collaborative pilot research Required to sub - ment of Lopez Biodiversity Conservation and and development program . mit requirements Jaena , Misamis Management Program for Lopez Jaena for ï쳌¡ ï쳌² ï쳌¡ . Occ . c / o Mayor Mis . Occ . Melquirades Azcuna Jr . Ms . Julie Tan ï?? ï?? / ï?? ï?? / ï?? ï?? Referred to Dept . c / o ï쳌¶ ï쳌© ï쳌³ ï쳌£ ï쳌¡ , Leyte of Health on ï?? ï?? / ï?? ï?? / ï?? ï?? . ï쳌µ ï쳌° Marine Science Marine Biodiversity Enhancement and ï?? ï?? / ï?? ï?? / ï?? ï?? Conservation oriented Referred to ï쳌¢ ï쳌¦ ï쳌¡ ï쳌² Institute c / o Dr . Sustainable Livelihood Program for activities . on 01 / 02 / 98 . Suzanne Licuanan the Hundred Islands Natural Park in the Lingayen Gulf . Zambasul Utilization of Bufo marinus for leather ï?? ï?? / ï?? ï?? / ï?? ï?? Collection of Cane Toad for Referred to ï쳌¢ ï쳌¦ ï쳌¡ ï쳌² Mercantile Exotic products . on 10 / 09 / 97 . utilization - leather products Skins Tannery c / o for direct trade and biological Mr . Reynaldo Chua control to cull toad popula - tion . Conservation Marine Rapid Assessment in Western ï?? ï?? / ï?? ï?? / ï?? ï?? Collection of marine speci - Referred to ï쳌¢ ï쳌¦ ï쳌¡ ï쳌² . Busuanga , Palawan . International mens for taxonomic / proper Philippines identification purposes and c / o Mr . Antonio de inventory of marine biologi - Castro cal resources in the area . St . Paul University Studies as part of thesis requirements . c / o Mr . Maximo Roger Pua ï?? ï?? ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ Box 3 . Research proposal format ___Academic ___ Commercial ï?? . Project title _____________________________________________________________________________________ ï?? . Project / Research objectives ï?? . ï?? _________________________________________________________________________________ ï?? . ï?? _________________________________________________________________________________ ï?? . ï?? _________________________________________________________________________________ ï?? . Places of collection _____________________________________________________________________________________ _____________________________________________________________________________________ Projected date of implementation and reason _____________________________________________________________________________________ _____________________________________________________________________________________ ï?? . Bioresources and quantity ( if possible ) ( indicate live or dead specimen , specify if by - products or deriva - tives ) _____________________________________________________________________________________ _____________________________________________________________________________________ ï?? . Methodology ( use separate sheet if necessary ) _____________________________________________________________________________________ _____________________________________________________________________________________ ï?? . Manner data to be gathered ( recorded , photographed , video , collected , observed , etc . ) and format ( notes , specimens , photographs , etc . ) _____________________________________________________________________________________ _____________________________________________________________________________________ ï?? . Anticipated intermediate and final destination of bioresources , etc . _____________________________________________________________________________________ _____________________________________________________________________________________ ï?? . How bioresources obtained are to be used initially ( i.e . , national collection ) subsequently ( e.g . , drug exploration , field guide preparation , etc . ) _____________________________________________________________________________________ _____________________________________________________________________________________ ï?? . Description of funding support with budget ( use separate sheet if necessary ) _____________________________________________________________________________________ _____________________________________________________________________________________ ï?? ï?? . Analysis of the research of foreseen impact on biological diversity _____________________________________________________________________________________ _____________________________________________________________________________________ ï?? ï?? . Detailed description of immediate compensation anticipated _____________________________________________________________________________________ _____________________________________________________________________________________ ï?? ï?? . Detailed description of long - term compensation anticipated _____________________________________________________________________________________ ï?? ï?? . List of in - country entities likely to receive compensation enumerated in # ï?? ï?? and reasons ( logical and legal ) _____________________________________________________________________________________ ï?? ï?? ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : P ï쳌¨ ï쳌© ï쳌¬ ï쳌© ï쳌° ï쳌° ï쳌© ï쳌® ï쳌¥ ï쳌³ Benefit sharing ary as a form of benefit sharing . There is no financing Local scientists view the benefit - sharing requirements mechanism or trust fund in place to support biodiversity under ï쳌¥ ï쳌¯ ï?? ï?? ï?? as too demanding . They also worry about conservation objectives ( O ï쳌£ ï쳌¨ ï쳌¡ ï쳌¶ ï쳌¥ ï?? ï?? ï?? ï?? ) . Although ï쳌¥ ï쳌¯ ï?? ï?? ï?? the involvement of local scientists in research which allows the proponent and the government and / or local may invade the confidentiality of information and may community to agree on possible arrangements that would jeopardize the chances for intellectual property rights ensure protection and conservation of biological diversity protection on commercially viable products ( T ï쳌¥ ï쳌£ ï쳌¨ ï쳌® ï쳌© ï쳌£ ï쳌¡ ï쳌¬ as part of the benefit - sharing agreement or tied with the S ï쳌¥ ï쳌£ ï쳌² ï쳌¥ ï쳌´ ï쳌¡ ï쳌² ï쳌© ï쳌¡ ï쳌´ ï?? ï?? ï?? ï?? ) . ï쳌° ï쳌© ï쳌£ , this is not always guaranteed because there are no There are others , however , who believe that the ben - concrete programs or mechanisms in place . efit - sharing provisions of ï쳌¥ ï쳌¯ ï?? ï?? ï?? are not enough . Other In response to the clamor for modification or revision of questions posed which they feel should be answered in - ï쳌¥ ï쳌¯ ï?? ï?? ï?? , new measures relative to bioprospecting were clude : How do we ensure equitable sharing , who should incorporated into the Wildlife Act . get what , how much , and for how long , what are the forms of benefit sharing , and will the community benefit ? ( ï쳌¥ ï쳌¯ The Wildlife Act ï?? ï?? ï?? W ï쳌¯ ï쳌² ï쳌« ï쳌³ ï쳌¨ ï쳌¯ ï쳌° ï?? ï?? ï?? ï?? ) . Some believe that the community On ï?? ï?? July ï?? ï?? ï?? ï?? , the Philippine Legislature enacted the should be given a bigger role in negotiating benefit sharing Wildlife Resources Conservation and Protection Act . As ( P ï쳌¥ ï쳌² ï쳌© ï쳌¡ ï?? ï?? ï?? ï?? ) . ï쳌¥ ï쳌¯ ï?? ï?? ï?? merely provides for the minimum a legislative act of the Philippine Congress , it passed terms and conditions so as to give the parties enough lee - through the regular process of enacting a statute in the way to negotiate . The problem is that effective bargaining Philippines . The act was initiated in the ï?? ï?? th Congress and negotiation have not yet been given much attention ( ï?? ï?? ï?? ï?? â?? ï?? ï?? ï?? ï?? ) but it was not passed into law at that time . by the implementers . In ï?? ï?? ï?? ï?? , five House bills were filed and consolidated into Biodiversity Conservation one House bill . A similar bill was filed in the Senate of Some also raise the issue that ï쳌¥ ï쳌¯ ï?? ï?? ï?? does not provide for the Philippines . The bills passed through several com - a mechanism to ensure that its goal to protect and conserve mittee meetings before they were discussed and voted biological and genetic resources is achieved . The functions on in the plenary sessions of both houses of Congress . of the ï쳌© ï쳌¡ ï쳌£ ï쳌¢ ï쳌§ ï쳌² do not even include resource protection , and Subsequently , the Lower House version was used as a conservation and technology transfer are merely second - working draft during the bicameral committee sessions . During the various committee meetings the following sec - tors were represented : government ( Bureau of Customs , Table ï?? . Application process for research agreements . Philippine National Museum , Department of Science Requirements for ï쳌¡ ï쳌² ï쳌¡ s and ï쳌£ ï쳌² ï쳌¡ s differ in steps ï?? and ï?? . and Technology , Bureau of Aquatic Resources , National Bureau of Investigation , Protected Areas and Wildlife Steps Bureau , Ecosystems Research and Development Bureau , ï?? . Submission of Letter of Intent and three copies of research proposal to the Technical Secretariat Department of Trade and Industry , National Committee ï?? . Initial screening by ï쳌´ ï쳌³ whether or not activity is covered by on Biosafety in the Philippines , ï쳌¡ ï쳌³ ï쳌¥ ï쳌¡ ï쳌® Regional Center 72 ï쳌¥ ï쳌¯ ï?? ï?? ï?? for Biodiversity Conservation ) ; the academy ( University ï?? . Submission of additional requirements of the Philippines ( ï쳌µ ï쳌° ) Marine Science Institute , Institute ï쳌¡ ï쳌² ï쳌¡ : Application form ; Institution profile ; Code of of Plant Breeding - ï쳌µ ï쳌° Los Baños ) ; business ( Floratrade / 73 conduct ; Environmental Impact Assessment , if Philippine Horticultural Society , SoutheastAsian Fisheries 74 necessary ; Processing fee Development Corp ) ; and ï쳌® ï쳌§ ï쳌¯ s ( Kalikasan Mindoro ï쳌£ ï쳌² ï쳌¡ : Application form ; Company / institution / organization Foundation and Conservation International ) . profile ; Environmental Impact Assessment , if necessary ; Based on the congressional records , there was a con - 75 Processing fee ; ï쳌° ï쳌© ï쳌£ certificate sensus that the passage of the Wildlife Act had been long ï?? . Initial evaluation by ï쳌´ ï쳌³ of application overdue . All participants ( both congressmen and resource ï?? . Submission of evaluation result to ï쳌© ï쳌¡ ï쳌£ ï쳌¢ ï쳌§ ï쳌² within ï?? ï?? days persons ) were in full support of the legislation , because 76 from receipt of all requirements existing laws on wildlife protection and conservation are ï?? . Final evaluation by ï쳌© ï쳌¡ ï쳌£ ï쳌¢ ï쳌§ ï쳌² outmoded and the penalties contained therein are very ï?? . Submission of ï쳌© ï쳌¡ ï쳌£ ï쳌¢ ï쳌§ ï쳌² â?? s recommendation to the Agency minimal . The new law will also enable the Philippines to 77 concerned meet its commitments to the Convention on International ï?? . Approval / Disapproval by the head of the Agency Trade in Endangered Species of Wild Fauna and Flora ï?? . Payment of fee and / or posting of bonds , if approved ( ï쳌£ ï쳌© ï쳌´ ï쳌¥ ï쳌³ ) ( Spot Report on the Meeting of the Committee ï쳌¡ ï쳌² ï쳌¡ : Bioprospecting fee on Ecology , ï?? December ï?? ï?? ï?? ï?? ) . The Wildlife Act is actu - ï쳌£ ï쳌² ï쳌¡ : Bioprospecting fee and Performance , compensation , ally a codification of existing laws on the protection and 78 ecological rehabilitation bond conservation of wildlife resources . As such , experiences ï?? ï?? . Transmittal of copies of agreement to applicant , ï쳌© ï쳌° , local in the implementation of existing laws helped a great deal community , Protected Areas Management Board ( ï쳌° ï쳌¡ ï쳌­ ï쳌¢ ) , or private landowner concerned in the design of the Wildlife Act . Concerns and issues ï?? ï?? ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ that have been plaguing lawmakers and that were raised forms and varieties of flora and fauna , in all devel - against the old laws were responded to in the law , such as opmental stages , including those which are in cap - 86 minimal penalties and unclear provisions relative to ï쳌£ ï쳌© ï쳌´ ï쳌¥ ï쳌³ . tivity or are being bred or propagated â?쳌 . Under the As far as bioprospecting is concerned , the act addressed proposed â?? Guidelines for BioprospectingActivities most of the concerns or criticisms made against ï쳌¥ ï쳌¯ ï?? ï?? ï?? . in the Philippines â?쳌 , wildlife , microorganisms , do - Thus , the discussions of the draft act in the committee mesticated or propagated species , and exotic spe - 87 level were not too heated . There were also no controversial cies are covered ( Section ï?? , ï?? . ï?? ) . provisions or issues . It would appear that the participants â?¢ An undertaking signed by the applicant binds him / who were the implementers of existing laws shared their her to comply with certain terms and conditions experiences and offered solutions to the problems that they 88 as may be imposed . The proposed Guidelines re - 79 encountered in the enforcement of these laws . The provi - quire the applicant to apply for a Bioprospecting sions on bioprospecting were drafted by the Department Undertaking ( ï쳌¢ ï쳌µ ) before access to biological of Environment and Natural Resources â?? Protected Areas resources for bioprospecting purposes is allowed and Wildlife Bureau which is the same agency primarily ( Section ï?? , ï?? . ï?? , see endnote ï?? ï?? ) . in charge of implementing ï쳌¥ ï쳌¯ ï?? ï?? ï?? . â?¢ The Secretary or its representative , in consultation The basic policy of the State in the Wildlife Act is â?? to with the concerned agencies , grants a permit to conserve the countryâ??s wildlife resources and their habitats conduct prospecting . This responds to the problems for sustainability â?쳌 . In the pursuit of said policy , the law inherent in the interagency approach established 80 has the following objectives : under ï쳌¥ ï쳌¯ ï?? ï?? ï?? . However , consultations with con - â?¢ Conserve and protect wildlife species and their cerned agencies are still necessary before any grant habitats to promote ecological balance and enhance for bioprospecting is allowed . biological diversity . â?¢ Prior informed consent from concerned ï쳌© ï쳌° s , local â?¢ Regulate the collection and trade of wildlife . communities , ï쳌° ï쳌¡ ï쳌­ ï쳌¢ , or a private individual entity â?¢ Pursue , with due regard to national interest , the is still required in accordance with existing laws , Philippine commitment to international conventions but the ï?? ï?? - day requirement , which had been widely on the protection of wildlife and their habitats . 89 criticized , has been removed . â?¢ Initiate or support scientific studies on the conserva - â?¢ In case the applicant is a foreign entity or indi - tion of biological diversity . vidual , a local institution shall actively participate in the research , collection , and , if applicable and The law covers all wildlife species found in all areas appropriate , the technological development of the of the country , including protected areas and critical habi - 90 products derived from the resources . tats . It also governs â?? exotic species which are subject to â?¢ A wildlife management fund is created which shall trade , are cultured , maintained , and / or bred in captivity or 81 finance rehabilitation or restoration of habitats af - propagated in the country â?쳌 . fected by acts committed in violation of the law Although there are only two provisions in the Wildlife 82 and support scientific research , enforcement and Act dealing with bioprospecting , these provisions modi - monitoring activities , and enhancement of capabili - fied ï쳌¥ ï쳌¯ ï?? ï?? ï?? considerably . Most of the changes that were 91 ties of relevant agencies . This answers the need introduced try to address the issues and concerns that were for a funding mechanism specifically intended raised against ï쳌¥ ï쳌¯ ï?? ï?? ï?? . These are as follows : for the conservation and protection of biological â?¢ Bioprospecting for purposes of scientific or aca - resources . demic research is no longer subject to the require - â?¢ Unauthorized collection , hunting , and possession of ments of the law for commercial bioprospecting . wildlife is punishable with imprisonment of up to Under the Wildlife Act , â?? bioprospecting â?쳌 is now four ( ï?? ) years and a fine of up to ï?? ï?? ï?? ï?? , ï?? ï?? ï?? P depend - defined as â?? the research , collection and utilization ing on the species illegally collected , hunted , or pos - of biological and genetic resources for purposes of 92 sessed . The law , however , is silent on the liability applying the knowledge derived therefrom solely 83 of a person illegally conducting bioprospecting . for commercial purposes â?쳌 . Collection and utiliza - tion of biological resources for scientific research With the passage of the Wildlife Act , ï쳌¥ ï쳌¯ ï?? ï?? ï?? has been 84 93 is covered by a gratuitous permit issued upon repealed by implication or amended accordingly and a 85 securing prior clearance from concerned bodies . new set of implementing rules and regulations on bio - 94 This is a welcome development for local scientists prospecting is currently being formulated by the ï쳌¤ ï쳌¥ ï쳌® ï쳌² . and researchers who have longed for the exclusion Thus , provisions in ï쳌¥ ï쳌¯ ï?? ï?? ï?? which are clearly contradictory of academic / scientific research from ï쳌¥ ï쳌¯ ï?? ï?? ï?? â?? s cov - to and irreconcilable with the WildlifeAct are now deemed erage . 95 repealed . However , the question as to what provisions of ï쳌¥ ï쳌¯ ï?? ï?? ï?? will remain in force and effect will be answered â?¢ The law governs all wildlife species found in all areas in the country . â?? Wildlife â?쳌 is defined as â?? wild only after the implementing rules and regulations have ï?? ï?? ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : P ï쳌¨ ï쳌© ï쳌¬ ï쳌© ï쳌° ï쳌° ï쳌© ï쳌® ï쳌¥ ï쳌³ been issued , inasmuch as the administrative interpretation is given the option to impose reasonable terms and con - of the law will have to be considered . New guidelines in ditions which are necessary to protect biodiversity . This accordance with the Wildlife Act and , perhaps , some of gives the Secretary of said agencies great flexibility in the still - effective provisions of ï쳌¥ ï쳌¯ ï?? ï?? ï?? will be formulated the conditions to be imposed . This clearly responds to to replace ï쳌¤ ï쳌¡ ï쳌¯ ï?? ï?? . Until such time , applications for a ï쳌£ ï쳌² ï쳌¡ the claim of local scientists that the minimum terms and will continue to be processed under ï쳌¥ ï쳌¯ ï?? ï?? ï?? . conditions of ï쳌¥ ï쳌¯ ï?? ï?? ï?? are unreasonable . Undoubtedly , the intention of the Wildlife Act is to Equitable sharing of benefits derived from the utiliza - simplify and facilitate access to biological and genetic tion of biological and genetic resources is not mentioned in resources . This is apparent in the very definition it has the law . It is unclear if the government , as a pre - condition provided for â?? bioprospecting â?쳌 . Since one of the complaints for the approval of the application , shall still require the against ï쳌¥ ï쳌¯ ï?? ï?? ï?? is that it stifles scientific research , the adoption of benefit - sharing arrangements . It is possible , scope of bioprospecting has been limited to commercial though , that any benefit - sharing option will now be tied purposes only . Also , the minimum terms and conditions up with the ï쳌° ï쳌© ï쳌£ certificate . found in ï쳌¥ ï쳌¯ ï?? ï?? ï?? were not legislated ; instead , the Secretary Intellectual Property Rights ( IPRs ) : Protection for Biological and Genetic Resources and Traditional Knowledge The present intellectual property law in the Philippines science culture ; b ) patent law applied to genetic resources is Republic Act No . ï?? ï?? ï?? ï?? , also known as the Intellectual represents a fusion of two fields , law and science , which Property Code of the Philippines ( ï쳌© ï쳌° ï쳌£ ) . It took effect on people , generally , do not understand ; c ) patent law is an - ï?? January ï?? ï?? ï?? ï?? and was enacted in compliance with the other imposition of the developed countries on the develop - 96 minimum standards set under ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ . ing countries , a view held by a number of ï쳌® ï쳌§ ï쳌¯ s which has Among the â?? intellectual property rights â?쳌 under the ï쳌© ï쳌° ï쳌£ , some basis in history ; and , d ) the wide chasm separating the patent is more relevant to the protection of biological the scientific and legal communities in the Philippines has and genetic resources and traditional knowledge associated caused even some scientists and technologists to have some with these resources . Section ï?? ï?? of the ï쳌© ï쳌° ï쳌£ provides that aversion toward patent law ( O ï쳌£ ï쳌¨ ï쳌¡ ï쳌¶ ï쳌¥ ï?? ï?? ï?? ï?? ) . â?? patentable invention â?쳌 refers to â?? any technical solution There is also a growing concern that ï쳌© ï쳌° ï쳌² systems under of a problem in any field of human activity which is new , ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ as applied to life forms run counter to the goals of the involves an inventive step , and is industrially applicable . ï쳌£ ï쳌¢ ï쳌¤ in the following aspects : a ) ï쳌© ï쳌° ï쳌² s hinder full realization It may be , or may relate to , a product , or process , or an ofArt . ï?? on national sovereignty andArticle ï?? j on Farmers â?? 99 improvement of any of the foregoing . â?쳌 Plant varieties or Rights ; b ) conservation of biodiversity is not compatible animal breeds or essentially biological processes for the with a global regime of private monopoly rights ; and c ) 97 production of plants or animals , except microorganisms ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ undermines the implementation of access and ben - and nonbiological and microbiological processes cannot be efit - sharing provisions because the resource will be under the subject of a patent . However , the Philippine legislature the control of the ï쳌© ï쳌° ï쳌² - holder ( M ï쳌µ ï쳌³ ï쳌¨ ï쳌© ï쳌´ ï쳌¡ ï?? ï?? ï?? ï?? ) . In particular , may consider the enactment of a law providing sui generis Article ï?? ï?? . ï?? ( b ) is said to be in conflict with goals of the protection for plant varieties or animal breeds and a system ï쳌£ ï쳌¢ ï쳌¤ and the International Undertaking on Plant Genetic 98 of community ï쳌© ï쳌° ï쳌² s protection . In short , the ï쳌© ï쳌° ï쳌£ chooses Resources insofar as conservation of biological diversity , to categorically exclude from patent protection plant va - specifically plant varieties , and equitable sharing of ben - rieties and animal breeds . It also does not give protection efits are concerned . Granting exclusive ï쳌© ï쳌° ï쳌² s to breeders to traditional knowledge but allows the creation of a sui will prevent certain established practices among farmers generis protection for community ï쳌© ï쳌° ï쳌² s . and indigenous communities , including common access Patent protection over life forms , including microor - to seeds and varieties , and most probably will be subject ganisms , remains a controversial issue in the Philippines . It to infringement sanctions ( C ï쳌¡ ï쳌¬ ï쳌© ï쳌­ ï쳌¯ ï쳌® ï?? ï?? ï?? ï?? ) . is argued that life forms are not eligible for patents because Nonetheless , others believe that the conflict is not nothing new is created , and the process merely involves between the ï쳌£ ï쳌¢ ï쳌¤ and ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ but arises only from the legis - reorganizing something that already exists ( B ï쳌¡ ï쳌µ ï쳌´ ï쳌© ï쳌³ ï쳌´ ï쳌¡ lation of individual member States , as in the case of plant ï?? ï?? ï?? ï?? ) . Some civil society groups clamor for total exclusion varieties â?? protection . It is said that under ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ , ï쳌© ï쳌° ï쳌² s need of any life form from patenting or even from sui generis not involve exclusive rights . Both international agree - protection due to moral and ethical issues . They consider ments require member States â?? to provide protection to it intrinsically wrong to patent any living organism . For plant varieties consistent with their obligation to conserve them , it violates the belief that only the divine creator can biological diversity , the sustainable use of its components , bring forth life ( B ï쳌¡ ï쳌µ ï쳌´ ï쳌© ï쳌³ ï쳌´ ï쳌¡ ï?? ï?? ï?? ï?? ) . and the fair and equitable sharing of the benefits arising out Other reasons given for distrust , if not rejection , of the of the utilization of genetic resources â?쳌 . ( C ï쳌¡ ï쳌¬ ï쳌© ï쳌­ ï쳌¯ ï쳌® ï?? ï?? ï?? ï?? ) . patent system as applied to life forms are the following : What is relevant for any plant protection law is the need a ) the Philippines suffers from a serious lack of visible to balance the protection of the ï쳌© ï쳌° ï쳌² s of breeders and the ï?? ï?? ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ interests and ï쳌© ï쳌° ï쳌² s of farmers and local indigenous com - and sale of seeds among and between small farmers , but munities . To interpret ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ â?? sArticle ï?? ï?? . ï?? b as not requiring only for purposes of reproduction and replanting in their 106 balancing of rights will run counter to the objectives of the own land . ï쳌£ ï쳌¢ ï쳌¤ ( C ï쳌¡ ï쳌¬ ï쳌© ï쳌­ ï쳌¯ ï쳌® ï?? ï?? ï?? ï?? ) . The law also allows compulsory licensing at any time And yet , this so - called â?? balancing of rights â?쳌 may be after two years from the grant of the ï쳌° ï쳌¶ ï쳌° when it is for easier said than done . It would be very difficult to bal - public interest and the reasonable requirements of the ance rights that are not equal to begin with . ï쳌© ï쳌° ï쳌² - holders public , overseas market for sale of any part of the variety are usually moneyed and backed by powerful and rich are not met or when the variety relates to or is required in governments while most farmers and ï쳌© ï쳌° s are not . In fact , the production of medicine and / or any food preparation . even in their own countries , ï쳌© ï쳌° s and farmers â?? rights are , The duration of the compulsory license ends when the more often than not , not recognized or protected . Even if ground for its issuance no longer exists as determined by 107 some balancing of rights is established through national the government . legislation , the problem of asserting their rights will still Any of the following acts constitutes infringement of persist because ï쳌© ï쳌° s and farmers have fewer resources or the plant breeders â?? plant variety protection : a ) sell , offer , none at all . expose for sale , deliver , ship , consign , exchange , solicit an The aversion to patenting life forms or even provid - offer to buy , or any other transfer of title or possession of ing sui generis protection that grants proprietary rights the novel variety ; b ) import into or export from the country over these resources to a single individual or corporation of the novel variety ; c ) sexually multiply the variety as a has been evident in how civil society and other interest step in marketing ( for growing purposes ) ; d ) use the novel groups view the ï?? ï?? ï?? ï?? Philippine Plant Variety Protection variety in producing ( as distinguished from developing ) ( ï쳌° ï쳌¶ ï쳌° ) law . In compliance with the countryâ??s obligations a hybrid or different variety therefrom ; e ) use seed which under ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ , the Philippine legislature passed a law which had been marked â?? unauthorized propagation prohibited â?쳌 or 100 gives protection to new plant varieties . Republic Act â?? unauthorized seed multiplication prohibited â?쳌 or progeny No . ï?? ï?? ï?? ï?? , entitled â?? An Act to Provide Protection to New thereof to propagate the novel variety ; f ) dispense the novel Plant Varieties , Establishing a National Plant Protection variety to another , in a form which can be propagated , 101 Board and for other purposes â?쳌 , recognizes that â?? an without notice as to being a protected variety under which effective intellectual property system in general and the it was received ; g ) fails to use a variety denomination , the development of new plant variety in particular is vital in use of which is obligatory under the act ; h ) perform any attaining food security for the country â?쳌 . As such , the law of the foregoing acts even in instances in which the novel aims to protect and secure the exclusive rights of breeders variety is multiplied other than sexually ; and i ) instigate or 102 108 with respect to their new plant variety . actively induce performance of any foregoing acts . Protection under Republic Act No . ï?? ï?? ï?? ï?? is patterned The passage of Republic Act No . ï?? ï?? ï?? ï?? has been criti - after the International Union for the Protection of New cized by civil societies and farmer groups . They believe Varieties of Plants ( ï쳌µ ï쳌° ï쳌¯ ï쳌¶ ) plant breeders â?? rights . The law that the law highlights multinational corporations â?? control provides that any breeder may be granted a Certificate of over the course of the Philippines â?? agriculture . Concern Plant Variety Protection for a particular plant variety upon about the survival of small farmers has been rising because showing that said variety is new , distinct , uniform , and sta - the law â?? prohibits them to continue with their traditional ble . A variety covered by a ï쳌° ï쳌¶ ï쳌° certificate is protected for practices of seed utilization â?쳌 . Farmers have always been ï?? ï?? years , or ï?? ï?? years in case of vines and trees , from date engaged in the art and science of plant breeding and selec - 103 of issuance of the certificate . The holder of the certifi - tion long before scientists and agribusiness corporations cate has the right to authorize production or reproduction ; came into being . They also freely store and exchange seeds conditioning for the purpose of propagation ; offering for among themselves , a process which played a major role in sale ; selling or other marketing ; exporting ; importing ; and development of new varieties ( M ï쳌¯ ï쳌² ï쳌¤ ï쳌¥ ï쳌® ï쳌¯ ï?? ï?? ï?? ï?? ) . All these stocking for any purpose mentioned above . Also , he may practices are now being endangered by the act . make his authorization subject to conditions and limita - Also , although ï쳌° ï쳌¶ ï쳌° is not strictly patent protection , 104 tions . Protection under the act extends to varieties which many consider the ï쳌µ ï쳌° ï쳌¯ ï쳌¶ - kind of protection as a â?? soft â?쳌 are essentially derived from the protected variety , where kind of patent regime which should likewise be rejected the protected variety is not itself an essentially derived vari - because it is just as â?? threatening as industrial patents on ety ; those which are not clearly distinct from the protected biodiversity and also represent an attack on the rights of variety ; and those whose production requires the repeated farming and other communities at the local level â?쳌 . Anti - 105 use of the protected variety . It does not , however , extend ï쳌µ ï쳌° ï쳌¯ ï쳌¶ groups have listed the following reasons why ï쳌µ ï쳌° ï쳌¯ ï쳌¶ to acts done for noncommercial , or experimental purposes ; should be opposed : a ) ï쳌µ ï쳌° ï쳌¯ ï쳌¶ denies farmers â?? rights ; b ) rich the purpose of breeding other varieties ; and to traditional Northern countries will take over national breeding sys - right of small farmers to save , use , exchange , share , or sell tems in poor Southern countries and get ownership of the their farm produce of a protected variety , except when a latterâ??s biodiversity with no obligation to share benefits ; sale is for the purpose of reproduction under a commercial c ) ï쳌µ ï쳌° ï쳌¯ ï쳌¶ criteria for protection will exacerbate erosion of marketing agreement . The act also exempts the exchange biodiversity ; d ) privatization of genetic resources affects ï?? ï?? ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : P ï쳌¨ ï쳌© ï쳌¬ ï쳌© ï쳌° ï쳌° ï쳌© ï쳌® ï쳌¥ ï쳌³ research negatively ; e ) moves to keep biodiversity under scientists / academics ) even if the end product or process was arrived at through informal innovation negotiated access systems will be undermined as ï쳌° ï쳌¶ ï쳌° of the community . laws grant private ownership of resources that fall under national and community sovereignty ; and f ) joining ï쳌µ ï쳌° ï쳌¯ ï쳌¶ â?¢ ï쳌© ï쳌° ï쳌² systems do not compensate the custodians of means accepting a questionable system that supports the biological resources even when these resources rights of industrial breeders and disregards farmers and are used for commercially profitable and legally communities ( D ï쳌¯ ï쳌¹ ï쳌¯ ï?? ï?? ï?? ï?? ) . protected inventions and end products . Furthermore , ï쳌© ï쳌° ï쳌² systems under ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ , specifically pat - â?¢ ï쳌© ï쳌° ï쳌² protection is said to favor those with ready ent laws and even ï쳌° ï쳌¶ ï쳌° , are inadequate to protect traditional access to economic and legal resources that local and community knowledge as well as inappropriate for de - communities often find hard to obtain . fending the rights and resources of local communities and ï쳌¥ ï쳌¯ ï?? ï?? ï?? and the WildlifeAct , and even the RepublicAct indigenous peoples . Traditional knowledge associated with No . ï?? ï?? ï?? ï?? also known as the Indigenous Peoples â?? Rights biological resources may not meet all the requirements Act ( ï쳌© ï쳌° ï쳌² ï쳌¡ ) , however , are not dependent on ï쳌© ï쳌° ï쳌² protection under traditional ï쳌© ï쳌° ï쳌² regimes such as novelty , inventive of biological resources , traditional knowledge , and benefit step , and industrial applicability ( î?? ï쳌¤ î?? ï쳌¯ ï쳌£ î?¶ ï쳌¯ ï쳌² ï쳌« ï쳌© ï쳌® ï쳌§ î?? ï쳌² ï쳌¯ ï쳌µ ï쳌° sharing . Access to traditional knowledge associated with ï쳌¯ ï쳌® î?? ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌¡ ï쳌® ï쳌¤ î?? ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ î?¬ ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï?? ï?? ï?? ï?? ) . The innovations , biological and genetic resources is not conditioned upon practices , and knowledge systems of ï쳌© ï쳌° s â?? were developed recognition of ï쳌© ï쳌° ï쳌² rights of the source community ( C ï쳌¨ ï쳌¡ ï쳌¯ collectively , accretionally over time , and inter - genera - ï?? ï?? ï?? ï?? ) . While the benefit - sharing provisions of ï쳌¥ ï쳌¯ ï?? ï?? ï?? for tionally â?쳌 ( D ï쳌¡ ï쳌¯ ï쳌¡ ï쳌³ ï?? ï?? ï?? ï?? ) . Thus , the conditions of novelty the utilization of biological and genetic resources mandate and innovative steps for the granting of patent may be payment of royalties , ï쳌¥ ï쳌¯ ï?? ï?? ï?? does not require that ï쳌© ï쳌° ï쳌² s be questionable . Also , knowledge is often held by different shared . In this sense , the regulation merely requires shar - independent communities ( î?? ï쳌¤ î?? ï쳌¯ ï쳌£ î?¶ ï쳌¯ ï쳌² ï쳌« ï쳌© ï쳌® ï쳌§ î?? ï쳌² ï쳌¯ ï쳌µ ï쳌° ï쳌¯ ï쳌® ing a portion of the proceeds ( e.g . , licensing fees ) . The î?? ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌¡ ï쳌® ï쳌¤ î?? ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ î?¬ ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï?? ï?? ï?? ï?? ) . It does not belong emerging view is that local counterparts should share in exclusively to one individual which is what a patent is all ï쳌© ï쳌° ï쳌² s only if they have actual participation in the innovations about ( D ï쳌¡ ï쳌¯ ï쳌¡ ï쳌³ ï?? ï?? ï?? ï?? ) . ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ is an embodiment of western developed ( ï쳌° ï쳌¡ ï쳌· ï쳌¢ - ï쳌¤ ï쳌¥ ï쳌® ï쳌² ï?? ï?? ï?? ï?? ) . legal philosophy : norms , values , and mindset that are con - Moreover , many believe that patent ownership is not trary to many ï쳌© ï쳌° s â?? cosmologies and values ( T ï쳌¡ ï쳌µ ï쳌¬ ï쳌© - C ï쳌¯ ï쳌² ï쳌° ï쳌µ ï쳌º the only form of benefit sharing and that contract law , not ï?? ï?? ï?? ï?? ) . Moreover , the existing ï쳌© ï쳌° ï쳌² system â?? promotes the patent law , is the key to ensuring that source countries or misappropriation of indigenous knowledge , with the result communities share in whatever benefits are derived from that the benefits derived from the commercialization of this the use of genetic resources . Thus , as correctly pointed knowledge do not flow back to the source communities out by José Maria A . Ochave , â?? if source countries or com - who freely shared the knowledge with outsiders â?쳌 ( T ï쳌¡ ï쳌µ ï쳌¬ ï쳌© - munities are to capture some of the benefits resulting from C ï쳌¯ ï쳌² ï쳌° ï쳌µ ï쳌º ï?? ï?? ï?? ï?? ) . the utilization of their genetic resources , they should focus Other reasons cited for the inadequacy and inappro - their attention not on the patent system , but on the nature priateness of ï쳌© ï쳌° ï쳌² systems under ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ for the protection of and content of their contractual relations with prospective traditional knowledge associated with biological resources bioprospectors â?쳌 ( î?¡ ï쳌£ ï쳌¨ ï쳌¡ ï쳌¶ ï쳌¥ ï?? ï?? ï?? ï?? ) . are the following ( C ï쳌¨ ï쳌¡ ï쳌¯ ï?? ï?? ï?? ï?? , î?? ï쳌¤ î?? ï쳌¯ ï쳌£ î?¶ ï쳌¯ ï쳌² ï쳌« ï쳌© ï쳌® ï쳌§ î?? ï쳌² ï쳌¯ ï쳌µ ï쳌° What is important for us is that any access to our ï쳌¯ ï쳌® î?? ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌¡ ï쳌® ï쳌¤ î?? ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ î?¬ ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï?? ï?? ï?? ï?? ) : resources and traditional knowledge must have the ap - â?¢ Patents do not provide incentives for innovations proval of the government through research agreements or generated at the community level . The recognition undertakings , and the prior informed consent of the local of value added through the ï쳌© ï쳌° ï쳌² regime appears lim - and indigenous communities obtained under existing laws , ited to the input of formal innovation ( made by rules , and regulations . Access to Indigenous Peoples â?? Biological Resources and Traditional Knowledge Access to biological resources within ancestral lands and property rights . Included under this is the â?? right to special measures to control , develop , and protect their sciences , ancestral domain is allowed under ï쳌¥ ï쳌¯ ï?? ï?? ï?? . Under ï쳌© ï쳌° ï쳌² ï쳌¡ , technologies , and cultural manifestations , including human the free and prior informed consent of the ï쳌© ï쳌° s is required and other genetic resources , seeds , including derivatives of prior to any access to these resources and their traditional these resources , traditional medicines and health practices , knowledge . Moreover , under ï쳌© ï쳌° ï쳌² ï쳌¡ , the rights of the ï쳌© ï쳌° s vital medicinal plants , animals and minerals , indigenous to their ancestral domains and lands , to self - governance knowledge systems and practices , knowledge of the prop - and empowerment , to self - justice and human rights , and erties of fauna and flora , oral traditions , literature , designs , 109 to cultural integrity have been recognized . The law 110 and visual and performing arts â?쳌 . Further , Sec . ï?? ï?? of also acknowledges the rights of the ï쳌© ï쳌° s to full ownership , said law provides that â?? access to biological and genetic control , and protection of their cultural and intellectual ï?? ï?? ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ resources and to indigenous knowledge related to the con - as sources in all such papers ; d ) copies of outputs of all such research shall be freely provided to the ï쳌© ï쳌£ ï쳌£ / ï쳌© ï쳌° s com - servation , utilization , and enhancement of these resources , munity ; and e ) ï쳌© ï쳌£ ï쳌£ / ï쳌© ï쳌° s shall be entitled to royalty from shall be allowed within ancestral lands and domains of the income derived from any research conducted and resulting ï쳌© ï쳌£ ï쳌£ s / ï쳌© ï쳌° s only with a free and prior informed consent of such publications ( D ï쳌¡ ï쳌¯ ï쳌¡ ï쳌³ ï?? ï?? ï?? ï?? ) . communities , obtained in accordance with customary laws Also in ï?? ï?? ï?? ï?? , Republic Act No . ï?? ï?? ï?? ï?? , also known of the concerned community â?쳌 . Under these provisions , a as the Traditional Alternative Medicine Act was passed form of community ï쳌© ï쳌° ï쳌² s of the ï쳌© ï쳌° s has been recognized . which , in a very limited way , protects traditional knowl - ï쳌© ï쳌° s have the right of restitution if these property rights are edge of traditional medicine . The law sets out the policy taken without their free and prior informed consent and of , among others , seeking a â?? legally workable basis by in violation of their customary laws . which indigenous societies would own their knowledge To safeguard the indigenous knowledge systems and of traditional medicine . When knowledge of traditional practices , the following guidelines have also been adopted medicine is used by outsiders , the indigenous societies pursuant to the law : a ) researchers and research institu - can require the permitted users to acknowledge its source tions , etc . shall secure the free and prior informed consent and can demand a share of any financial return that may of the ï쳌© ï쳌£ ï쳌£ / ï쳌© ï쳌° s before access to indigenous peoples and 111 come from its authorized commercial use . â?쳌 To date , resources can be allowed ; b ) a written agreement shall be however , the Philippines has yet to pass a sui generis ï쳌© ï쳌° ï쳌² entered into with the ï쳌© ï쳌£ ï쳌£ / ï쳌© ï쳌° s concerned regarding the re - system that will cover traditional knowledge associated search , including its purpose , design and expected output ; with biological and genetic resources of local and indig - c ) all data provided by the ï쳌© ï쳌£ ï쳌£ / ï쳌© ï쳌° s shall be acknowledged enous communities . in whatever writings , publications , or journals produced as a result of such research and the ï쳌© ï쳌£ ï쳌£ / ï쳌© ï쳌° s will be named Equitable Sharing of Benefits The Wildlife Act is silent on benefit sharing . Therefore , â?¢ Supplies and equipment for resource conservation activities ; the provisions of ï쳌¥ ï쳌¯ ï?? ï?? ï?? on sharing of benefits are still relevant and effective . ï쳌¥ ï쳌¯ ï?? ï?? ï?? employs a contractual ap - â?¢ Technology transfer ; proach in ensuring equitable sharing of benefits . This gives â?¢ Formal training including educational facilities ; it flexibility . Benefit sharing is required at two stages : at â?¢ Infrastructure directly related to the management the time of collection and at the time of commercialization . of the area ; At the time of collection , the minimum benefits that must â?¢ Health care ; and be obtained are explicitly provided for in ï쳌¥ ï쳌¯ ï?? ï?? ï?? , while benefit sharing at the time of commercialization is not â?¢ Other capacity building and support for in - situ expressly stated . However , the parties are free to negoti - conservation and development activities . ate on the kind of benefit - sharing arrangement / option that 112 Under the ï쳌¤ ï쳌¡ - Utah - ï쳌µ ï쳌° ï쳌£ ï쳌² ï쳌¡ , the parties agreed to the will be established . â?? equitable sharing of benefits , direct or indirect , short or long The proposed Guidelines for BioprospectingActivities term , including , but not limited to direct assistance , technol - also employ negotiation for benefits where the resource ogy transfer , profit sharing , co - ownership of intellectual prop - user negotiates with the resource providers for the benefit - 113 erty â?쳌 . Aside from the minimum terms and conditions on sharing arrangements that will govern them . However , the benefit sharing stipulated in ï쳌¥ ï쳌¯ ï?? ï?? ï?? and ï쳌¤ ï쳌¡ ï쳌¯ ï?? ï?? , the following Guidelines impose minimum benefits that must be obtained 114 arrangements have been agreed upon by the parties : from the resource user . These are as follows ( Secs . ï?? ï?? and â?¢ Utah - ï쳌µ ï쳌° shall share ï?? % of the net revenue received ï?? ï?? , see endnote ï?? ï?? ) : and derived from any invention such as licensing â?¢ Bioprospecting fee of ï?? ï?? , ï?? ï?? ï?? ï쳌µ ï쳌³ ï쳌¤ for each ï쳌¢ ï쳌µ , fee , milestone payments , or royalty from the com - which may be increased or tempered based on mercialization of any material to the ï쳌¤ ï쳌¡ ( or the ï쳌© ï쳌° ï쳌¡ ï쳌¦ , certain criteria ; if material was taken from the protected area ) and â?¢ Minimum amount of ï?? % of total global gross sales the concerned community who gave the ï쳌° ï쳌© ï쳌£ . of the products made or derived from collected â?¢ All materials and products derived therefrom , all samples to be paid annually ; and data , documents , and publications shall contain a â?¢ ï?? ï?? , ï?? ï?? ï?? ï쳌µ ï쳌³ ï쳌¤ per collection site annually for the compulsory attribution recognizing the country and duration of the collection period . community of the origin of the materials used . Nonmonetary benefits , which may be agreed upon in â?¢ ï쳌µ ï쳌° shall develop an information / education module addition to the minimum benefits , may include ( Sec . ï?? ï?? , on resource conservation and environmental protec - see endnote ï?? ï?? ) : tion especially geared for the community where the collections are to be made . â?¢ Equipment for biodiversity inventory and monitor - ing ; â?¢ ï쳌µ ï쳌° shall provide technical expertise to enable the ï?? ï?? ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : P ï쳌¨ ï쳌© ï쳌¬ ï쳌© ï쳌° ï쳌° ï쳌© ï쳌® ï쳌¥ ï쳌³ ï쳌© ï쳌¡ ï쳌£ ï쳌¢ ï쳌§ ï쳌² to develop / implement a monitoring scheme who will benefit will rely heavily on the negotiating teams for marine bioprospecting . for the community and the government , on one hand , and the bioprospector , on the other . The following proposals â?¢ ï쳌µ ï쳌° shall help train at least one government repre - ( O ï쳌£ ï쳌¨ ï쳌¡ ï쳌¶ ï쳌¥ ï?? ï?? ï?? ï?? ) may be considered in strengthening the sentative in sponge / ascidian taxonomy or natural bargaining position of the source country : products chemistry through short - term internship / observation programs . â?¢ Alternative ways for protecting community re - sources should be explored . â?¢ ï쳌µ ï쳌° shall conduct an information campaign on the protection / conservation of coastal resources and â?¢ The scientific and legal communities should work the value of coastal resources . together to increase understanding of each otherâ??s â?¢ In case inventions are derived from the use of ma - field . Contract negotiations should not be left to terials , Utah - ï쳌µ ï쳌° shall provide training in a marine - lawyers who know nothing about genes , or to sci - related discipline if there is a qualified candidate entists who may not appreciate the ramifications from the community . of seemingly innocuous contract terms . â?¢ Regional cooperation , in various forms , will en - There are a lot of possible benefit - sharing options , but able the entire region to present a common front under a contractual scheme , everything will depend on ef - fective bargaining . How much , how long , how many , and in negotiations . ASEAN Protocol on Access to Genetic Resources Regional cooperation has long been the call of ï쳌® ï쳌§ ï쳌¯ s , standards in regulating access to genetic resources and government agencies , and scientists . Such cooperation is strengthening national initiatives towards this objective â?쳌 , necessary because , it is not only the Philippines that has promotion of technology transfer and capacity building , endemic species ; there are species endemic to the entire and establishment of â?? effective and participatory measures 116 southeast Asian region as well . for the grant of ï쳌° ï쳌© ï쳌£ â?쳌 . 114 During the eighth meeting of the ï쳌¡ ï쳌³ ï쳌¥ ï쳌¡ ï쳌® Senior The Framework covers all genetic and biological re - Officials on Environment ( ï쳌¡ ï쳌³ ï쳌¯ ï쳌¥ ï쳌® ) in September ï?? ï?? ï?? ï?? , sources , including associated traditional knowledge . Ex the Philippine delegation proposed the formulation of situ materials collected prior to the ï쳌£ ï쳌¢ ï쳌¤ are considered held 117 a common protocol among ï쳌¡ ï쳌³ ï쳌¥ ï쳌¡ ï쳌® member countries on in trust and ï쳌© ï쳌° ï쳌² shall not be allowed . Patenting of life access to genetic resources and ï쳌© ï쳌° ï쳌² s . Thereafter , ï쳌¡ ï쳌³ ï쳌¯ ï쳌¥ ï쳌® forms and traditional knowledge as well as ï쳌© ï쳌° ï쳌² on genetic 118 asked the ï쳌¡ ï쳌³ ï쳌¥ ï쳌¡ ï쳌® Working Group on Nature Conservation materials of human origin shall not be allowed . Prior and Biodiversity to spearhead the drafting of said protocol . informed consent of member countries is necessary before The Philippines was given the lead role in formulating a access to these resources shall be allowed . Countries shall legal framework to regulate access to genetic resources establish a legal process to ensure that fair and equitable for ï쳌¡ ï쳌³ ï쳌¥ ï쳌¡ ï쳌® . The first Technical Expertâ??s Meeting was held sharing of benefits shall accrue to ï쳌© ï쳌° s and local communi - in December ï?? ï?? ï?? ï?? to discuss and draft the framework . ties who are considered as the legitimate users and custodi - 119 It was composed of technical experts from the member ans of biological and genetic resources . The negotiation countries , ï쳌® ï쳌§ ï쳌¯ s from the region and representative of the of benefit - sharing arrangements is left to the discretion of ï쳌¡ ï쳌³ ï쳌¥ ï쳌¡ ï쳌® Secretariat . The second Technical Expertâ??s Meeting member States and may come in the form of technology was held in February ï?? ï?? ï?? ï?? ( M ï쳌¯ ï쳌¬ ï쳌© ï쳌® ï쳌¹ ï쳌¡ ï쳌· ï쳌¥ ï?? ï?? ï?? ï?? ) . transfer , capacity building , and monetary or nonmonetary 120 Although the ï쳌¡ ï쳌³ ï쳌¥ ï쳌¡ ï쳌® Framework on Access to benefits subject to certain requirements . Biological and Genetic Resources is still being developed , The Framework also establishes a Common Fund it may already have created the regional cooperation that for Biodiversity Conservation consisting of a share in has long been desired in the region . In the ï?? ï?? February the revenues derived from any commercialization of the 115 ï?? ï?? ï?? ï?? draft of the Framework , the objectives include , use of common and shared resources among the member among others , ensuring the conservation and sustainable States as well as from a portion of the fees and charges use of these resources and equitable sharing of benefits imposed by the member States.Additional support shall be consistent with the principle of ï쳌° ï쳌© ï쳌£ , giving recognition derived from other benefit - sharing arrangements that may 121 and protection to traditional knowledge , promotion of be negotiated . According to the ï쳌¡ ï쳌³ ï쳌¥ ï쳌¡ ï쳌® Ha Noi Action regional cooperation in the utilization of and access to Plan ( ï?? ï?? ï?? ï?? â?? ï?? ï?? ï?? ï?? ) the ï쳌¡ ï쳌³ ï쳌¥ ï쳌¡ ï쳌® Protocol was scheduled to these resources , ensuring uniform and consistent access be adopted in ï?? ï?? ï?? ï?? . regulations within the region , the setting of â?? minimum ï?? ï?? ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ Conclusions and Recommendations Ultimately , the legislative and institutional framework ï쳌° ï쳌© ï쳌£ , is a must in any access regulation , because it is the only for access to genetic resources that any country devel - way for States to help and support the ï쳌© ï쳌° s â?? capacities and ops will only be as good as the process through which efforts to protect their indigenous / traditional knowledge it is developed . To actually work once established , the and resources . â?? Effective , on - the - ground mechanisms to legislative framework must have the broad support of all ensure the ï쳌° ï쳌© ï쳌£ and protection of the rights of affected relevant sectors of government and society ; fit within the communities â?쳌 are necessary ( B ï쳌¡ ï쳌² ï쳌¢ ï쳌¥ ï쳌² and L ï쳌¡ V ï쳌© ï?± ï쳌¡ ï?? ï?? ï?? ï?? ) . countryâ??s larger strategy for conserving and sustainably Nevertheless , the ï쳌° ï쳌© ï쳌£ process should be simple and fast . using biodiversity ; and must be supported by institu - There is a need for an effective and efficient implement - tional processes and capabilities sufficient to implement ing mechanism and monitoring scheme . A single but effec - it ( M ï쳌µ ï쳌§ ï쳌¡ ï쳌¢ ï쳌¥ et al . ï?? ï?? ï?? ï?? ) . tive , efficient , and well - funded implementing agency must Executive Order ï?? ï?? ï?? has been faithful to the provisions of be established . Lack of funds and personnel to implement the Convention on Biological Diversity on access regula - the access regulation will surely mean failure of whatever tion . It is the worldâ??s first comprehensive policy framework system that is implemented . that provides for access to biological resources on mutu - The procedure must be simple and fast . A straightfor - ally agreed terms , subject to prior informed consent , and ward application procedure will lessen the transaction cost the equitable sharing of benefits . Since its issuance , the for the collector . Documentary requirements should be Philippines has approved only one commercial research minimal and only that information necessary for evaluation agreement and one academic research agreement . The purposes should be required . â?? If requests for access are fees and bonds are still undetermined and a monitoring poorly administered â?? too bureaucratic , confusing , involv - scheme is not yet in place . However , for the only ï쳌£ ï쳌² ï쳌¡ ing too many steps , too slow or too onerous â?? or based on that has been approved so far , bioprospectors are asked benefit - sharing policies that seem unreasonable to the user , to submit a quarterly report and a government representa - partnership will seem unattractive , and providers will price tive joins them during every field visit . At present , a draft themselves out of the market â?쳌 ( ï쳌´ ï쳌¥ ï쳌® K ï쳌¡ ï쳌´ ï쳌¥ ï?? ï?? ï?? ï?? ) . administrative regulation on collection and monitoring of Biodiversity conservation and access must go hand - in - bioprospecting activities is being reviewed by ï쳌© ï쳌¡ ï쳌£ ï쳌¢ ï쳌§ ï쳌² . hand . The access regulation should provide for measures Benefit - sharing arrangements are yet to be tried . The to guarantee that bioprospecting activities will not be other terms and conditions are still to be threshed out . All detrimental to biodiversity conservation . Benefit - sharing these have been compounded by a new law ( the Wildlife arrangements should also include benefits accruing to en - Act ) radically modifying ï쳌¥ ï쳌¯ ï?? ï?? ï?? . vironmental protection and conservation programs . This does not mean , however , that ï쳌¥ ï쳌¯ ï?? ï?? ï?? has failed There must be regional cooperation among countries in its purpose . It only shows that the road towards the sharing the same resource . This will help create a united establishment of an ideal framework for access to and and strong position during negotiations for optimum ben - exchange of biological and genetic resources is long and efits . â?? A consortium of suppliers could pool their expertise tedious . However , the Philippines is learning a lot along and equipment , offer a greater quantity and diversity of the way . In fact , the passage of the Wildlife Act confirms resources and services and agree to share among them - that the process is dynamic , and the country intends to selves , in proportion to the samples supplied , the royalties succeed in finding a better legislative and institutional derived from any single marketed product . Others suggest framework on the subject . that regional cooperatives could provide a mechanism for Derived from the years of Philippine experience on sharing the benefits from access to species common to the access regulation under ï쳌¥ ï쳌¯ ï?? ï?? ï?? , the following recommen - region â?쳌 ( ï쳌´ ï쳌¥ ï쳌® K ï쳌¡ ï쳌´ ï쳌¥ ï?? ï?? ï?? ï?? ) . dations may help other countries in their quest for the Effective guidelines or mechanisms to attain equitable best and most suitable mode of regulating access to and benefit sharing and technology transfer must be developed . exchange of biological and genetic resources : Identification and implementation of benefit sharing and There is a need to be clear as to the scope of the access technology transfer options must be incorporated . If the regulation . States should know what they want to regulate State decides to adopt contractual relations , it has to cre - in order to avoid over - regulation . They should conduct ate an effective bargaining program in order to ensure assessments of their genetic resources and their capacities optimum benefits for its people . Also , in the long run , to regulate access to their resources and make a realistic the market for raw genetic material will be increasingly decision on the coverage of their regulation . competitive ( made more so by a growing black market ) The prior informed consent ( ï쳌° ï쳌© ï쳌£ ) of communities should as a result of technological changes in the field of bio - be nonnegotiable and measures that would guarantee com - technology . It is imperative , therefore , to develop stable , pliance with the ï쳌° ï쳌© ï쳌£ process must be established . The ï쳌° ï쳌© ï쳌£ long - term partnerships with product development firms and institutions ( ï쳌´ ï쳌¥ ï쳌® K ï쳌¡ ï쳌´ ï쳌¥ ï?? ï?? ï?? ï?? ) . of communities and ï쳌© ï쳌° s , and the process of obtaining the ï?? ï?? ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : P ï쳌¨ ï쳌© ï쳌¬ ï쳌© ï쳌° ï쳌° ï쳌© ï쳌® ï쳌¥ ï쳌³ References î?? ï쳌¤ î?? ï쳌¯ ï쳌£ î?¶ ï쳌¯ ï쳌² ï쳌« ï쳌© ï쳌® ï쳌§ î?? ï쳌² ï쳌¯ ï쳌µ ï쳌° ï쳌¯ ï쳌® î?? ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌¡ ï쳌® ï쳌¤ î?? ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ î?¬ ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ . M ï쳌¯ ï쳌² ï쳌¤ ï쳌¥ ï쳌® ï쳌¯ H.M . ï?? ï?? ï?? ï?? . Seeds of discontent : Republic Act ï?? ï?? ï?? ï?? . Report on the role of intellectual property rights ï?? ï?? ï?? ï?? in perspective . MindaNews I : ï?? ï?? . ï쳌µ ï쳌² ï쳌¬ : http : / / in the implementation of access and benefit - sharing ar - www.mindanews.com / ï?? ï?? ï?? ï?? / ï?? ï?? / ï?? rd / vws ï?? ï?? mordeno.html . rangements . First Ad Hoc Open - ended Working Group M ï쳌µ ï쳌§ ï쳌¡ ï쳌¢ ï쳌¥ J . , C.V . B ï쳌¡ ï쳌² ï쳌¢ ï쳌¥ ï쳌² , H . G ï쳌µ ï쳌¤ ï쳌² ï쳌µ ï쳌® , L . G ï쳌¬ ï쳌¯ ï쳌· ï쳌« ï쳌¡ , and A . on Access and Benefit Sharing , ï?? ï?? - ï?? ï?? October ï?? ï?? ï?? ï?? , L ï쳌¡ V ï쳌© ï?± ï쳌¡ . ï?? ï?? ï?? ï?? . Access to genetic resources : Strategies ï쳌µ ï쳌® ï쳌¥ ï쳌° / ï쳌£ ï쳌¢ ï쳌¤ / ï쳌· ï쳌§ - ï쳌¡ ï쳌¢ ï쳌³ / ï?? / ï?? . Bonn , Germany . ï쳌µ ï쳌² ï쳌¬ : http : for sharing benefits . ï쳌· ï쳌² ï쳌© , ï쳌¥ ï쳌¬ ï쳌£ - ï쳌© ï쳌µ ï쳌£ ï쳌® , ï쳌¡ ï쳌£ ï쳌´ ï쳌³ Press , Nairobi , / / www.biodiv.org / doc / meetings / abs / abswg - ï?? ï?? / official / Kenya . abswg - ï?? ï?? - ï?? ï?? - en.pdf . M ï쳌µ ï쳌³ ï쳌¨ ï쳌© ï쳌´ ï쳌¡ T.A . ï?? ï?? ï?? ï?? . Access , benefit sharing and trade in A ï쳌§ ï쳌° ï쳌¡ ï쳌¬ ï쳌¯ R . ï?? ï?? ï?? ï?? . Statutory construction . Rex Bookstore , Inc . , genetic resources . Paper presented at ï쳌© ï쳌£ ï쳌´ ï쳌³ ï쳌¤ / ï쳌¡ ï쳌² ï쳌´ Regional Manila , Philippines . Seminar on Trade and Environment , ï?? ï?? â?? ï?? ï?? February B ï쳌¡ ï쳌² ï쳌¢ ï쳌¥ ï쳌² , C.V . and A.G.M . L ï쳌¡ V ï쳌© ï?± ï쳌¡ . ï?? ï?? ï?? ï?? . Regulating access ï?? ï?? ï?? ï?? . Harare , Zimbabwe . ï쳌µ ï쳌² ï쳌¬ : http : / / www.ictsd.org / to genetic resources : The Philippine experience . p . ï?? ï?? ï?? â?? dlogue / ï?? ï?? ï?? ï?? - ï?? ï?? - ï?? ï?? / mushita.pdf . ï?? ï?? ï?? in î?? . M ï쳌µ ï쳌§ ï쳌¡ ï쳌¢ ï쳌¥ , C.V . B ï쳌¡ ï쳌² ï쳌¢ ï쳌¥ ï쳌² , G . H ï쳌¥ ï쳌® ï쳌® ï쳌¥ , L . G ï쳌¬ ï쳌¯ ï쳌· ï쳌« ï쳌¡ O ï쳌£ ï쳌¨ ï쳌¡ ï쳌¶ ï쳌¥ J.M.A . ï?? ï?? ï?? ï?? . Barking at the wrong tree : Intellectual and A . L ï쳌¡ V ï쳌© ï?± ï쳌¡ ( eds . ) . Access to genetic resources . ï쳌· ï쳌² ï쳌© , property law and genetic resources . Paper presented at the ï쳌¥ ï쳌¬ ï쳌£ - ï쳌© ï쳌µ ï쳌£ ï쳌® , ï쳌¡ ï쳌£ ï쳌´ ï쳌³ Press , Nairobi , Kenya . Regional Workshop on Sustainable Utilization of Genetic B ï쳌¡ ï쳌µ ï쳌´ ï쳌© ï쳌³ ï쳌´ ï쳌¡ L.R . ï?? ï?? ï?? ï?? . ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ agreement revisited : Focus on Resources in Southeast Asia and the Pacific , ï?? â?? ï?? ï?? July article ï?? ï?? . ï?? ( b ) . World Bulletin ï?? ï?? : ï?? ï?? ï?? â?? ï?? ï?? ï?? . ï?? ï?? ï?? ï?? , Grand Men Seng Hotel , Davao City , Philippines . C ï쳌¡ ï쳌¬ ï쳌© ï쳌­ ï쳌¯ ï쳌® D.J.L . ï?? ï?? ï?? ï?? . Plant variety protection and rights O ï쳌£ ï쳌¨ ï쳌¡ ï쳌¶ ï쳌¥ J.M.A . ï?? ï?? ï?? ï?? . The anticommons in bioprospecting : of breeders , farmers and indigenous peoples under Regulation of access to genetic and biological materials in Philippine law . World Bulletin ï?? ï?? : ï?? ï?? ï?? â?? ï?? ï?? ï?? . the Philippines . World Bulletin ï?? ï?? : ï?? ï?? ï?? - ï?? ï?? ï?? . C ï쳌¨ ï쳌¡ ï쳌¯ I.M.C . ï?? ï?? ï?? ï?? . Foraging for a fair share : Strategies ï쳌° ï쳌¡ ï쳌· ï쳌¢ - ï쳌¤ ï쳌¥ ï쳌® ï쳌² . ï?? ï?? ï?? ï?? . The First Philippine National Report for minimizing inequity between bioprospectors and to the Convention on Biological Diversity . Protected Philippine local communities . World Bulletin ï?? ï?? : ï?? ï?? ï?? â?? ï?? ï?? ï?? . Areas and Wildlife Bureau - Department of Environment D ï쳌¡ ï쳌§ ï쳌¤ ï쳌¡ ï쳌§ ï쳌¡ ï쳌® V.L . ï?? ï?? ï?? ï?? . To catch the â?? biopirates . â?쳌 ï쳌° ï쳌£ ï쳌¨ ï쳌² ï쳌¤ and Natural Resources . Manila , Philippines . ï쳌µ ï쳌² ï쳌¬ : http : Bulletin ï?? ï?? : ï?? â?? ï?? . / / www.biodiv.org / doc / world / ph / ph - nr - ï?? ï?? - en.pdf . D ï쳌¡ ï쳌¯ ï쳌¡ ï쳌³ D . ï?? ï?? ï?? ï?? . Efforts at protecting traditional knowl - P ï쳌¥ ï쳌² ï쳌© ï쳌¡ E.V . ï?? ï?? ï?? ï?? . Canâ??t we stop and talk awhile ? A Philippine edge : The experience of the Philippines . Roundtable ï쳌® ï쳌§ ï쳌¯ perspective on Executive Order No . ï?? ï?? ï?? . Paper on Intellectual Property and Traditional Knowledge , presented at the ï?? ï?? th Global Biodiversity Forum in World Intellectual Property Organization . ï쳌µ ï쳌² ï쳌¬ : http : Bratislava , Slovakia , ï?? â?? ï?? May ï?? ï?? ï?? ï?? . Southeast Asia / / www.wipo.int / documents / en / meetings / ï?? ï?? ï?? ï?? / folklore / Regional Institute for Community Education ( ï쳌³ ï쳌¥ ï쳌¡ ï쳌² ï쳌© ï쳌£ ï쳌¥ ) , pdf / tkrt ï?? ï?? _ ï?? . pdf . Philippines . D ï쳌¥ L ï쳌¥ ï쳌¯ ï쳌® J.L . ï?? ï?? ï?? ï?? . Wildlife resources in the Philippines and S ï쳌· ï쳌© ï쳌¤ ï쳌¥ ï쳌² ï쳌³ ï쳌« ï쳌¡ K . ï?? ï?? ï?? ï?? . Stakeholder participation in policy government efforts to conserve them . Manila , Philippines . on access to genetic resources , traditional knowledge and benefit - sharing case studies and recommendations . D ï쳌¯ ï쳌¹ ï쳌¯ M.C . ï?? ï?? ï?? ï?? . Set free the seeds ( ï?? ) : A sovereignty issue . Biodiversity and Livelihood Issues ï?? : ï?? ï?? . Human Face . Philippine Daily Inquirer . ï?? ï?? February ï?? ï?? ï?? ï?? . T ï쳌¡ ï쳌® ï쳌´ ï쳌© ï쳌¡ E.M . ï?? ï?? ï?? ï?? . Position paper of the Pharmaceutical and ï쳌¥ ï쳌¯ ï?? ï?? ï?? W ï쳌¯ ï쳌² ï쳌« ï쳌³ ï쳌¨ ï쳌¯ ï쳌° ï?? ï?? ï?? ï?? . Compilation of issues , comments , Healthcare Association of the Philippines ( ï쳌° ï쳌¨ ï쳌¡ ï쳌° ) on access and suggestions reached during the ï쳌¥ ï쳌¯ ï?? ï?? ï?? seminars / to genetic resources and benefit - sharing policies . Paper workshops sponsored by Southeast Asia Regional presented at the East Asia Forum on Genetic Resources Institute for Community Education . Access and Benefit Sharing Policies . Cavite , Philippines . L ï쳌¡ V ï쳌© ï?± ï쳌¡ A.G.M . , M.J.A . C ï쳌¡ ï쳌¬ ï쳌¥ ï쳌¤ ï쳌¡ , and M.L.L . B ï쳌¡ ï쳌¹ ï쳌¬ ï쳌¯ ï쳌® . ï?? ï?? ï?? ï?? . T ï쳌¡ ï쳌µ ï쳌¬ ï쳌© - C ï쳌¯ ï쳌² ï쳌° ï쳌µ ï쳌º V . ï?? ï?? ï?? ï?? . ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ and its potential impacts on Regulating access to biological and genetic resources indigenous peoples . Indigenous Peoples â?? International in the Philippines : A manual on the implementation of Centre for Policy Research and Education , Philippines . Executive Order No . ï?? ï?? ï?? . Foundation for Philippine ï쳌µ ï쳌² ï쳌¬ : http : / / www.wcc - coe.org / wcc / what / jpc / trips ï?? . html . Environment and World Resources Institute , Quezon City , Philippines . T ï쳌¥ ï쳌£ ï쳌¨ ï쳌® ï쳌© ï쳌£ ï쳌¡ ï쳌¬ S ï쳌¥ ï쳌£ ï쳌² ï쳌¥ ï쳌´ ï쳌¡ ï쳌² ï쳌© ï쳌¡ ï쳌´ . ï?? ï?? ï?? ï?? . Status of Executive Order M ï쳌¡ ï쳌¤ ï쳌µ ï쳌¬ ï쳌© ï쳌¤ D.A . ï?? ï?? ï?? ï?? . On bioprospecting and collection of ï?? ï?? ï?? implementation . Inter - Agency Committee on biological specimens in the Philippines . Philippine Biological and Genetic Resources , Philippines . Biodiversity Information Center Plant Unit Newsletter ï?? : ï?? . ï쳌´ ï쳌¥ ï쳌® K ï쳌¡ ï쳌´ ï쳌¥ K . ï?? ï?? ï?? ï?? . Biopiracy or green petroleum ? : M ï쳌¯ ï쳌¬ ï쳌© ï쳌® ï쳌¹ ï쳌¡ ï쳌· ï쳌¥ N . ï?? ï?? ï?? ï?? . Chronology of events / status of draft Expectations and best practice in bioprospecting . ï쳌¡ ï쳌³ ï쳌¥ ï쳌¡ ï쳌® framework on access to biological and genetic Overseas Development Administration , Environment resources . Department of Environment and Natural Policy Department London , ï쳌µ ï쳌« . Resources , Protected Areas and Wildlife Bureau . Manila , Philippines . ï?? ï?? ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ Endnotes 1 22 ï쳌² ï쳌¡ ï?? ï?? ï?? ï?? , Sec . ï?? . ï쳌¤ ï쳌¥ ï쳌® ï쳌² Special Order No . ï?? ï?? - ï?? ï?? ï?? dated ï?? ï?? March ï?? ï?? ï?? ï?? ï?? . 23 2 ï쳌¤ ï쳌¥ ï쳌® ï쳌² Special Order No . ï?? ï?? - ï?? ï?? ï?? , Sec . ï?? . ï?? . ï?? . Ibid . 24 3 Affiliate refers to a registered student or scientist / researcher who is ï쳌¥ ï쳌¯ ï?? ï?? ï?? is entitled â?? Prescribing Guidelines and Establishing a formally appointed to a staff or faculty position in a university or Regulatory Framework for the Prospecting of Biological and other academic institution acting as principal , or a representative of Genetic Resources , Their By - products and Derivatives , for a domestic academic or governmental institution or a representative Scientific and Commercial Purposes and For Other Purposes â?쳌 . The of an inter - governmental institution assisting in the bioprospecting full text is available at ï쳌µ ï쳌² ï쳌¬ : http : / / www.chmbio.org.ph / eo ï?? ï?? ï?? . html . research by virtue of a formal agreement duly signed by both the 4 Implementing rules and regulations â?? issued by administrative or principal and the affiliate or a certified true copy of his enrollment executive officers in accordance with , and as authorized by , law form in the case of a registered student ( ï쳌¤ ï쳌¡ ï쳌¯ ï?? ï?? - ï?? ï?? , Sec . ï?? . ï?? , b ) . have the force and effect of law or partake of the nature of a stat - 25 ï쳌¥ ï쳌¯ ï?? ï?? ï?? , Definition of Terms . ute . All that is required for their validity is that the rules should be 26 germane to the objects and purposes of the law ; that the regulations ï쳌¥ ï쳌¯ ï?? ï?? ï?? , Sec . ï?? ( m ) . be not in contradiction with , but conform to , the standards that the 27 The institution with an ï쳌¡ ï쳌² ï쳌¡ with the government is referred to as law prescribes ; and that they be the sole purpose of carrying into the principal . effect the general provisions of the law â?쳌 ( A ï쳌§ ï쳌° ï쳌¡ ï쳌¬ ï쳌¯ ï?? ï?? ï?? ï?? ) . 28 ï쳌¤ ï쳌¡ ï쳌¯ ï?? ï?? - ï?? ï?? , Sec . ï?? ( ï?? . ï?? ) ( ï?? ) . 5 Full text of Administrative Order No . ï?? ï?? is available at : ï쳌µ ï쳌² ï쳌¬ : http : 29 Id . , Sec . ï?? ( ï?? . ï?? ) ( ï?? & ï?? ) . / / www.chmbio.org.ph / dao ï?? ï?? - ï?? ï?? . html . 30 Id . , Sec . ï?? ( ï?? . ï?? ) ( ï?? ) . 6 Guidelines for the collection of biological specimens in the 31 ï쳌¥ ï쳌¯ ï?? ï?? ï?? , Definition of ï쳌£ ï쳌² ï쳌¡ and ï쳌¤ ï쳌¡ ï쳌¯ ï?? ï?? - ï?? ï?? , Sec . ï?? ( ï?? . ï?? ) ( ï?? ) . Philippines ( hereinafter Guidelines ) , Part II , Section ï?? . 32 7 Ibid . The letter of agreement between the ï쳌® ï쳌£ ï쳌© and the National Museum is an open - ended contract that is still enforceable but no activity 33 Id . , Sec . ï?? ( ï?? . ï?? ) ( ï?? ) . has been undertaken by them in the last five years ( D.A . Madulid , 34 ï쳌© ï쳌¡ ï쳌£ ï쳌¢ ï쳌§ ï쳌² has received ï?? ï?? applications for ï쳌£ ï쳌² ï쳌¡ but ï?? of those ap - pers . comm . , 28 February 2002 ) . Also , according to the ï쳌´ ï쳌³ of plications are exempt from ï쳌¥ ï쳌¯ ï?? ï?? ï?? coverage . The pending ï쳌£ ï쳌² ï쳌¡ ï쳌© ï쳌¡ ï쳌£ ï쳌¢ ï쳌§ ï쳌² , there is no information that ï쳌® ï쳌£ ï쳌© is doing bioprospecting applications are still being processed under ï쳌¥ ï쳌¯ ï?? ï?? ï?? until new activity with other institutions in the Philippines . implementing rules and regulations pursuant to the new Wildlife 8 Interview with Dr . Madulid , Head , Philippine National Herbarium , Act are issued . ï?? ï?? February ï?? ï?? ï?? ï?? at the National Museum , Manila , Philippines . 35 ï쳌© ï쳌¡ ï쳌£ ï쳌¢ ï쳌§ ï쳌² has received ï?? ï?? applications for ï쳌¡ ï쳌² ï쳌¡ but ï?? of those ap - 9 ï쳌¥ ï쳌¯ ï?? ï?? ï?? , Sec . ï?? . plications are exempt from ï쳌¥ ï쳌¯ ï?? ï?? ï?? coverage . With the passage 10 of the Wildlife Act , all pending applications for ï쳌¡ ï쳌² ï쳌¡ shall not be Public domain refers to water and lands owned by the State that processed anymore but shall undergo the ï쳌­ ï쳌¯ ï쳌¡ gratuitous permit have not been declared alienable and disposable ( ï쳌¤ ï쳌¡ ï쳌¯ No . ï?? ï?? - ï?? ï?? , system . Sec . ï?? ( z ) ) . 36 11 The ï쳌£ ï쳌² ï쳌¡ between the Department of Agriculture ( ï쳌¤ ï쳌¡ ) and the ï쳌¤ ï쳌¡ ï쳌¯ ï?? ï?? - ï?? ï?? , Sec . ï?? ( ï?? . ï?? ) ( a ) . University of Utah ( principal collector ) and the University of the 12 ï쳌¥ ï쳌¯ ï?? ï?? ï?? , Definition of Terms . Philippines ( ï쳌µ ï쳌° ) was approved on ï?? ï?? June ï?? ï?? ï?? ï?? ( seven months after 13 Traditional use refers to customary utilization of biological and the project applied for access ) ( ï쳌¤ ï쳌¡ - Utah - ï쳌µ ï쳌° ï쳌£ ï쳌² ï쳌¡ ) . The ï쳌£ ï쳌² ï쳌¡ expired genetic resources by the local community and indigenous people on ï?? July ï?? ï?? ï?? ï?? and was renewed until ï?? ï?? ï?? ï?? . The project involves in accordance with written or unwritten rules , usages , customs , and the collection of tunicates , sponges , and other invertebrate samples practices traditionally observed , accepted , and recognized by them for biological assays to screen for potential bioactive compounds . ( ï쳌¤ ï쳌¡ ï쳌¯ ï?? ï?? - ï?? ï?? , Sec . ï?? ( bb ) ) . So far , no products have been developed , but some organisms have 14 Id . , Sec . ï?? ( ï?? . ï?? ) ( b ) . yielded interesting results . Also , the project has been academically productive because of the publications derived from it . 15 The applicant for these kinds of research and collection is given a 37 ï쳌¡ ï쳌² ï쳌¡ of the University of the Philippines System was approved in gratuitous permit under a ï쳌­ ï쳌¯ ï쳌¡ . Some of the minimum terms and ï?? ï?? ï?? ï?? . conditions under ï쳌¥ ï쳌¯ ï?? ï?? ï?? are , however , incorporated in the ï쳌­ ï쳌¯ ï쳌¡ so as to avoid circumvention of the law . 38 ï쳌¥ ï쳌¯ ï?? ï?? ï?? , Sec . ï?? . 16 39 ï쳌¤ ï쳌¡ ï쳌¯ ï?? ï?? - ï?? ï?? , sec . ï?? . ï?? ( a ) . ï쳌¤ ï쳌¡ ï쳌¯ ï?? ï?? - ï?? ï?? , Sec . ï?? ( w ) . 17 40 Application of Pascual Laboratories , Inc . ( ï쳌° ï쳌¬ ï쳌© ) for a Commercial Ancestral domain , subject to existing property rights , refers â?? to all Research Agreement in connection with its desire to work with areas generally belonging to ï쳌© ï쳌° s comprising lands , inland waters , Oxford Natural Products in standardizing Lagundi and Sambong coastal areas , and natural resources therein , held under a claim of Tablets using the latterâ??s technology called â?? Total Quality ownership , occupied or possessed by ï쳌© ï쳌° s , by themselves or through Profiling â?쳌 . The application is now undergoing ï쳌© ï쳌¡ ï쳌£ ï쳌¢ ï쳌§ ï쳌² â?? s final evalu - their ancestors , communally or individually , since time immemo - ation . rial , continuously to the present except when interrupted by war , 18 force majeure , or displacement by force , deceit , stealth or as a con - Indigenous people refers â?? to a group of people sharing common sequence of government projects or any other voluntary dealings bonds of language , customs , traditions , and other distinct cultural entered into by government and private individuals / corporations , traits , and who have since time immemorial , occupied , possessed , and which are necessary to ensure their economic , social and and utilized a territory except when such possession is either cultural welfare . It shall include ancestral lands , forests , pasture , prevented or interrupted by war , force majeure , displacement by residential , agricultural , and other lands individually owned force , deceit , or stealth , or other usurpation â?쳌 ( ï쳌¥ ï쳌¯ ï?? ï?? ï?? , Definition of whether alienable and disposable or otherwise , hunting grounds , Terms ) . burial grounds , worship areas , bodies of water , mineral and other 19 ï쳌¤ ï쳌¡ ï쳌¯ ï?? ï?? - ï?? ï?? , Sec . ï?? ï?? . ï?? . natural resources , and lands which may no longer be exclusively 20 ï쳌¤ ï쳌¡ ï쳌¯ ï?? ï?? - ï?? ï?? , Sec . ï?? . occupied by ï쳌© ï쳌° s but which they traditionally had access to for their 21 ï쳌¤ ï쳌¡ ï쳌¯ ï?? ï?? - ï?? ï?? , Sec . ï?? . subsistence and traditional activities , particularly the home rangers ï?? ï?? ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : P ï쳌¨ ï쳌© ï쳌¬ ï쳌© ï쳌° ï쳌° ï쳌© ï쳌® ï쳌¥ ï쳌³ of ï쳌© ï쳌° s who are still nomadic and / or shifting cultivators â?쳌 ( ï쳌¤ ï쳌¡ ï쳌¯ ï?? ï?? - assess ï쳌¥ ï쳌¯ ï?? ï?? ï?? . Various stakeholders participated in these work - shops where issues and concerns affecting the implementation ï?? ï?? , Sec . ï?? . ï?? , c ) . of ï쳌¥ ï쳌¯ ï?? ï?? ï?? were identified and solutions / recommendations were 41 Ancestral land , subject to existing property rights , refers â?? to land formulated . The results were later transmitted to the ï쳌© ï쳌¡ ï쳌£ ï쳌¢ ï쳌§ ï쳌² . occupied , possessed and utilized by individuals , families , and clans 71 Under the ï쳌¤ ï쳌¡ - Utah - ï쳌µ ï쳌° ï쳌£ ï쳌² ï쳌¡ , Utah / ï쳌µ ï쳌° paid ï?? ï?? ï?? , ï?? ï?? ï?? P bioprospecting who are members of the ï쳌© ï쳌£ ï쳌£ s / ï쳌© ï쳌° s since time immemorial , continu - fee and posted ï?? ï?? ï?? , ï?? ï?? ï?? P bond ( ï?? ï?? USD = ï?? ï?? ï?? P ) . ously to the present except when interrupted by war , force majeure , 72 or displacement by force , deceit , stealth or as a consequence of If the research is not covered by ï쳌¥ ï쳌¯ ï?? ï?? ï?? , the ï쳌´ ï쳌³ shall issue a government projects or any other voluntary dealings entered into Certificate of Exemption and refer the proposal to the government by government and private individuals / corporations , and which are agency that has jurisdiction over the project . necessary to ensure their economic , social , and cultural welfare â?쳌 73 Under the Philippine Environmental Impact Statement System , an ( Id . , Sec . ï?? . ï?? , d ) . Environmental Impact Assessment ( ï쳌¥ ï쳌© ï쳌¡ ) is required for any activity 42 ï쳌² ï쳌¡ ï?? ï?? ï?? ï?? , Sec . ï?? ï?? . that affects the quality of the environment . An ï쳌¥ ï쳌© ï쳌¡ is a systematic 43 study of the relationship between a proposed project and its sur - ï쳌² ï쳌¡ ï?? ï?? ï?? ï?? , Sec . ï?? ( g ) . rounding environment . In particular , environmentally critical proj - 44 The research proposal must be presented in a language or dialect ects or those located in environmentally critical areas are required understandable to them stating therein the purpose , methodology , to undergo the process established under the system . ( Presidential duration , species / specimen , and number / quantity to be used and / or Decree No . ï?? ï?? ï?? ï?? and its implementing rules and regulations ) . Here taken , equitable sharing of benefits , if any , to parties concerned , it is important to note that no ï쳌¥ ï쳌© ï쳌¡ was required for the ï쳌¤ ï쳌¡ - Utah - ï쳌µ ï쳌° and a categorical statement that said activity will not affect their ï쳌£ ï쳌² ï쳌¡ . traditional use of the resource ( ï쳌¤ ï쳌¡ ï쳌¯ ï?? ï?? - ï?? ï?? , Sec . ï?? ( ï?? . ï?? . ï?? ) ) . 74 Processing fee for Philippine nationals is ï?? ï?? , ï?? ï?? ï?? P while for foreign 45 The notice includes a statement that copies of a summary of the national it is ï?? ï?? , ï?? ï?? ï?? P per application for both ï쳌¡ ï쳌² ï쳌¡ and ï쳌£ ï쳌² ï쳌¡ . research proposal and other information regarding the proposed 75 For ï쳌¡ ï쳌² ï쳌¡ , the applicant submits the ï쳌° ï쳌© ï쳌£ Certificate after the signing activity have been filed with the recognized head of the ï쳌© ï쳌° , the local of the agreement . ( See discussion on ï쳌° ï쳌© ï쳌£ ) . government unit , ï쳌° ï쳌¡ ï쳌­ ï쳌¢ , or the private landowner concerned and 76 that an application is pending with the ï쳌© ï쳌¡ ï쳌£ ï쳌¢ ï쳌§ ï쳌² , or that the research A draft ï쳌¡ ï쳌² ï쳌¡ / ï쳌£ ï쳌² ï쳌¡ shall be included if the evaluation is favorable . is covered by an existing ï쳌¡ ï쳌² ï쳌¡ ( Id . , Sec . ï?? ( ï?? . ï?? . ï?? ) ) . 77 The Agency head / s who will sign the agreement will depend on the 46 Undergraduate , masters , and doctoral students carrying out type of research ( pharmaceutical , agricultural , etc . ) and the nature research strictly for the purpose of complying with academic of the resources ( terrestrial , marine , etc ) . requirements and who do not receive any funding from a com - 78 Fees and bonds required under ï쳌¥ ï쳌¯ ï?? ï?? ï?? are still undetermined . mercial entity are exempt from holding community consultation A draft â?? Guidelines on the Collection and Monitoring of the unless requested . The consultation shall be held in the presence of Prospecting of Biological and Genetic Materials and Prescribing representatives of the ï쳌© ï쳌¡ ï쳌£ ï쳌¢ ï쳌§ ï쳌² / ï쳌® ï쳌§ ï쳌¯ s / ï쳌° ï쳌¯ s . ( Id . , Sec . ï?? ( ï?? . ï?? . ï?? ) ) . the Fees , Bonds , Royalties and Benefit - Sharing Scheme thereto â?쳌 is 47 Id . , Sec . ï?? ( ï?? . ï?? ) ( ï?? & ï?? ) . still under review . 48 79 Id . , Sec . ï?? ( ï?? . ï?? ) ( ï?? ï?? ) . The following are some of the issues that were raised during the 49 discussions on the Wildlife Act : ï쳌¥ ï쳌¯ ï?? ï?? ï?? , Sec . ï?? ( b ) . â?¢ Simplification of a permitting system for science and technol - 50 ï쳌¤ ï쳌¡ ï쳌¯ ï?? ï?? - ï?? ï?? , Sec . ï?? ( ï?? . ï?? ) ( ï?? ï?? ) . ogy research and development . 51 Id . , Sec . ï?? ( ï?? . ï?? ) ( ï?? ) . â?¢ The need to provide a list of species that are banned / restricted 52 for prosecution purposes . Id . , Sec . ï?? ( ï?? . ï?? ) ( ï?? ) . â?¢ Add and define the term â?? cultured species â?쳌 to distinguish from 53 ï쳌¥ ï쳌¯ ï?? ï?? ï?? , Sec . ï?? ( b ) . captive - bred or propagated species . 54 Id . , Sec . ï?? ( h ) . â?¢ Government agencies mandated to do research must be exempt 55 ï쳌¤ ï쳌¡ ï쳌¯ ï?? ï?? - ï?? ï?? , Sec . ï?? ( ï?? . ï?? ) ( ï?? ) . from securing permits for collection . 56 â?¢ A sound scientific study should be conducted before any re - Id . , Sec . ï?? ( ï?? . ï?? ) ( ï?? ï?? ) . stocking activity is performed as well as before any importation 57 ï쳌­ ï쳌´ ï쳌¡ is not provided for in ï쳌¥ ï쳌¯ ï?? ï?? ï?? or ï쳌¤ ï쳌¡ ï쳌¯ ï?? ï?? - ï?? ï?? but it has been and introduction of exotic species . made part of the research agreement . â?¢ Those listed under the ï쳌£ ï쳌© ï쳌´ ï쳌¥ ï쳌³ should be exempted from exploi - 58 ï쳌¥ ï쳌¯ ï?? ï?? ï?? , Sec . ï?? ( a ) ; ï쳌¤ ï쳌¡ ï쳌¯ ï?? ï?? - ï?? ï?? , Secs . ï?? ( ï?? . ï?? . ï?? ) , ï?? ( ï?? . ï?? ) ( ï?? ) , ï?? ( ï?? . ï?? ) tation except for scientific , education , and / or experimental ( ï?? ) , ï?? ( ï?? . ï?? ) ( ï?? ) , ï?? ( ï?? . ï?? ) ( ï?? ï?? ) . breeding / propagation purposes . 59 â?¢ Include compliance with biosafety protocol as one requirements ï쳌¤ ï쳌¡ ï쳌¯ ï?? ï?? - ï?? ï?? , Sec . ï?? ( ï?? . ï?? ) ( ï?? ) . for importation . 60 Id . , Sec . ï?? ( ï?? . ï?? ) ( ï?? ï?? ) . â?¢ There is a need to enhance institutional capability to execute 61 ï쳌¥ ï쳌¯ ï?? ï?? ï?? , Sec . ï?? ( l ) . This remains to be threshed out and is subject to and handle biosafety procedures , hence the need to provide for further study . ( î?? ï쳌¡ ï쳌´ ï쳌© ï쳌¯ ï쳌® ï쳌¡ ï쳌¬ î?« ï쳌¥ ï쳌° ï쳌¯ ï쳌² ï쳌´ ï?? ï?? ï?? ï?? ) . institutional development . 62 ï쳌¤ ï쳌¡ ï쳌¯ ï?? ï?? - ï?? ï?? , Sec . ï?? ( ï?? . ï?? ) ( ï?? ) . 80 ï쳌² ï쳌¡ ï?? ï?? ï?? ï?? , Sec . ï?? . 63 Id . , Sec . ï?? ( ï?? . ï?? ) ( ï?? ï?? ) . 81 Id . , Sec . ï?? . 64 Id . , Sec . ï?? ï?? ( ï?? ï?? . ï?? ) . 82 Id . , Secs . ï?? ï?? and ï?? ï?? . 65 Id . , Sec . ï?? ï?? ( ï?? ï?? . ï?? ) . 83 Id . , Sec . ï?? ( a ) . 66 Id . , Sec . ï?? ï?? ( ï?? ï?? . ï?? ) . 84 Gratuitous permit means â?? a permit issued to any individual or en - 67 Id . , Sec . ï?? ï?? ( ï?? ï?? . ï?? ) . tity engaged in noncommercial scientific or educational undertak - ing to collect wildlife â?쳌 ( Sec . ï?? ( l ) , ï쳌² ï쳌¡ ï?? ï?? ï?? ï?? ) . 68 Id . , Sec . ï?? ï?? ( ï?? ï?? . ï?? ) . 85 The law does not define â?? prior clearance â?쳌 . It will be clarified in the 69 â?? Determining the coverage of ï쳌¥ ï쳌¯ ï?? ï?? ï?? was from the start the most implementing rules and regulations . difficult issue â?쳌 ( Antonio La Viña , pers com . ï?? January ï?? ï?? ï?? ï?? ) . 86 Sec . ï?? ( x ) , ï쳌² ï쳌¡ ï?? ï?? ï?? ï?? . 70 In ï?? ï?? ï?? ï?? , the Southeast Asia Regional Institute for Community 87 Education sponsored a series of seminars / workshops to review / Draft Guidelines for Bioprospecting Activities in the Philippines ï?? ï?? ï?? ï?? ï?? ï?? 101 ( Joint ï쳌¤ ï쳌¥ ï쳌® ï쳌² - ï쳌¤ ï쳌¡ - ï쳌° ï쳌£ ï쳌³ ï쳌¤ - ï쳌® ï쳌£ ï쳌© ï쳌° Administrative Order No . 1 ) . Available It took effect on ï?? June ï?? ï?? ï?? ï?? . at ï쳌µ ï쳌² ï쳌¬ : http : / / www.denr.gov.ph / article / view / 2332 / . 102 ï쳌² ï쳌¡ ï?? ï?? ï?? ï?? , Sec . ï?? ( a ) . 88 Sec . ï?? ï?? , ï쳌² ï쳌¡ ï?? ï?? ï?? ï?? . 103 Id . , Sec . ï?? ï?? . 89 Ibid . 104 Id . , Sec . ï?? ï?? , ï?? ï?? and ï?? ï?? . 90 Ibid . 105 Id . , Sec . ï?? ï?? . 91 Sec . ï?? ï?? , ï쳌² ï쳌¡ ï?? ï?? ï?? ï?? . 106 Id . , Sec . ï?? ï?? . 92 Sec . ï?? ï?? ( f ) and Sec . ï?? ï?? , ï쳌² ï쳌¡ ï?? ï?? ï?? ï?? . 107 Id . , Secs . ï?? ï?? and ï?? ï?? . 93 The repealing clause provides â?? Act Nos . ï?? ï?? ï?? ï?? and ï?? ï?? ï?? ï?? , 108 Id . , Sec . ï?? ï?? . The violator may be charged before a court of justice Commonwealth Act No . ï?? ï?? , as amended , Presidential Decree and penalized with imprisonment of not less than ï?? years but not No . ï?? ï?? ï?? ï?? , as amended , Republic Act No . ï?? ï?? ï?? ï?? , and other laws , more than ï?? years and / or a fine of up to ï?? times the profit derived orders and regulations inconsistent herewith are hereby repealed or by virtue of the infringement but in no case should be less than one amended accordingly . â?쳌 hundred thousand pesos ( ï?? ï?? ï?? ï?? , ï?? ï?? ï?? P ) ( ï쳌² ï쳌¡ ï?? ï?? ï?? ï?? , Sec . ï?? ï?? ) . 94 Within ï?? ï?? months following the effective date of the law , rules and 109 Id . , Secs . ï?? ( b ) and ( c ) & ï?? . regulations shall be promulgated ( Sec . ï?? ï?? , ï쳌² ï쳌¡ ï?? ï?? ï?? ï?? ) . 110 Id . , Secs . ï?? ï?? and ï?? ï?? . 95 There are two categories of repeals by implication . The first is 111 î?« î?? ï?? ï?? ï?? ï?? , Sec . ï?? . where provisions in the two acts on the same subject matter are in 112 The ï쳌£ ï쳌² ï쳌¡ is now up for renewal under the same terms and condi - irreconcilable conflict , the later act , to the extent of the conflict , tions as the original ï쳌£ ï쳌² ï쳌¡ . constitutes an implied repeal of the earlier one . The second is if the 113 later act covers the whole subject of the earlier one and is clearly ï쳌¤ ï쳌¡ - Utah - ï쳌µ ï쳌° , ï쳌£ ï쳌² ï쳌¡ Item IX . intended as a substitute , it will operate similarly to a repeal of the 114 The Association of South East Asian Nations ( ï쳌¡ ï쳌³ ï쳌¥ ï쳌¡ ï쳌® ) includes earlier act ( A ï쳌§ ï쳌° ï쳌¡ ï쳌¬ ï쳌¯ ï?? ï?? ï?? ï?? ) . the Philippines , Thailand , Indonesia , Malaysia , Singapore , Brunei 96 The ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ Agreement has not been difficult to accept . Philippine Darussalam , Cambodia , Vietnam , Myanmar , and Laos . patent and trademark laws needed only some adjustments and the 115 The text of the draft is available at ï쳌µ ï쳌² ï쳌¬ http : / / www.iprsonline.org / country is also a signatory to the relevant conventions identified in legalinstruments / docs / asean_framework_agreement.pdf the Agreement ( B ï쳌¡ ï쳌µ ï쳌´ ï쳌© ï쳌³ ï쳌´ ï쳌¡ ï?? ï?? ï?? ï?? ) . 116 Draft ï쳌¡ ï쳌³ ï쳌¥ ï쳌¡ ï쳌® Framework Agreement on Access to Biological and 97 As of ï?? ï?? ï?? ï?? , more than ï?? ï?? ï?? microorganisms have been granted pat - Genetic Resources . , Art . ï?? . ent protection in the Philippines ( B ï쳌¡ ï쳌µ ï쳌´ ï쳌© ï쳌³ ï쳌´ ï쳌¡ ï?? ï?? ï?? ï?? ) . 117 The Philippines also shares this position . 98 ï쳌² ï쳌¡ ï?? ï?? ï?? ï?? , Sec . ï?? ï?? . 118 Draft ï쳌¡ ï쳌³ ï쳌¥ ï쳌¡ ï쳌® Framework Agreement on Access to Biological and 99 In the Philippines , some groups are urging the government to Genetic Resources . , Art . ï?? . protect its national interest â?? by strongly lobbying against patenting 119 Id . , Art . ï?? ï?? . of plant varieties which will give power to the ï?? ï?? giant world seed 120 Id . , Art . ï?? ï?? . producers to violate farmers â?? and indigenous peoples â?? rights and 121 culture â?쳌 ( D ï쳌¡ ï쳌§ ï쳌¤ ï쳌¡ ï쳌§ ï쳌¡ ï쳌® ï?? ï?? ï?? ï?? ) . Id . , Art . ï?? ï?? . 100 At present , no Philippine law has yet been enacted providing sui generis protection for animal breeders and community intellectual rights . ï?? ï?? ï?? 8 The United States of America : The National Park Service Experience Preston T . Scott The biological diversity and related genetic resources in Rio de Janeiro in ï?? ï?? ï?? ï?? , efforts to deal with some of the existing in the United States of America ( ï쳌µ ï쳌³ ï쳌¡ ) is vast . same issues have been part of the legal landscape in the ï쳌µ ï쳌³ ï쳌¡ The ï쳌µ ï쳌³ ï쳌¡ spans a continent bordered by two oceans , and for decades ( albeit in a less systematic way ) . For example , includes territory stretching from the Arctic Circle to the formalized regulations relating to access to biological re - tropics . While much of the country has been industrialized sources found in ï쳌µ ï쳌³ ï쳌¡ national parks for scientific research and developed , the wide range of ecosystems found in the purposes date back to the ï?? ï?? ï?? ï?? s . Since the ï?? ï?? ï?? ï?? s , the ï쳌µ ï쳌³ ï쳌¡ ï쳌µ ï쳌³ ï쳌¡ contributes to an equally wide range of representative Public Health Service ( led by the National Institutes of samples of diverse life forms . Health and other major research agencies ) has developed In light of the great diversity of life found in the various and implemented standardized approaches concerning the ecosystems that exist throughout the ï쳌µ ï쳌³ ï쳌¡ , scientists have management of biological material for research purposes . begun to study the nationâ??s biodiversity in more systematic These particular examples arose from perceived needs for ways . Such studies have begun to result in new appreciation new management tools to be applied in specific contexts for the value of biodiversity to environmental and social and to respond to specific sets of circumstances . well being , as well as to the potential economic value that Accordingly , much of the experience in the ï쳌µ ï쳌³ ï쳌¡ can result from important discoveries rooted in biological concerning the regulation of access to genetic resources material . The value of biological material ( particularly at actually pre - dates much of the international discussion as a molecular and genetic level ) is increasingly recognized , it has evolved in connection with the ï쳌£ ï쳌¢ ï쳌¤ . However , the and the value of related discoveries and product inventions ï쳌µ ï쳌³ ï쳌¡ experience has not been characterized by the â?? top - is growing rapidly ( primarily as a result of the application down â?쳌 central - government approach often reflected in of intellectual property rights and other research - related ï쳌£ ï쳌¢ ï쳌¤ - related texts . It also has evolved independently from laws ) . While there are no reliable nationwide statistics on the non - self - implementing framework agreement ap - the number of so - called â?? bioprospecting â?쳌 projects cur - proach reflected most notably in the ï쳌£ ï쳌¢ ï쳌¤ . Instead , it has rently underway in the ï쳌µ ï쳌³ ï쳌¡ , reports suggest that the number developed in response to various specialized sets of needs is growing but affected by many different factors . and circumstances often existing at very local or specific Access to genetic resources in the ï쳌µ ï쳌³ ï쳌¡ is governed by institutional levels . a dizzying array of laws , regulations , and policies that ap - The fundamental issues relating to access to natural ply at various different local , state , regional , and national resources in the ï쳌µ ï쳌³ ï쳌¡ are ordinarily managed by the owner levels.Although the recognition and refinement of the prin - of the resource ( whether private or public ) . In the ï쳌µ ï쳌³ ï쳌¡ , such ciples related to access , sustainable use , and the equitable fundamental issues relating to ownership of property and sharing of benefits arising from the utilization of biologi - resources are typically managed at very local and individu - cal resources has become increasingly sophisticated since alized levels . For example , in cases of wild biodiversity adoption of the Convention on Biological Diversity ( ï쳌£ ï쳌¢ ï쳌¤ ) living on private lands , access is subject to the approval ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ of the individual landowner . Where areas are managed representative samples â?? and in many cases the best ex - by governmental authorities , access is usually subject to amples â?? of virtually every type of ecosystem found in the regulation ( whether local , state , or federal ) . Marine areas ï쳌µ ï쳌³ ï쳌¡ . The chapter continues with a look back at the history may be subject to special regulations and laws enforced of scientific research at Yellowstone , including a descrip - by both federal and state authorities . In addition , access tion of the natural resources that have attracted scientists to tribal lands in the ï쳌µ ï쳌³ ï쳌¡ are subject to tribal authorities to the park for more than a century . This is followed by an and associated federal and state laws relating specifically overview of the development and status of the laws and to Native Americans . regulations that relate to the value of biological research All of this complexity is amplified by the fact that ju - in the ï쳌µ ï쳌³ ï쳌¡ , and that now govern access to the ï쳌® ï쳌° ï쳌³ genetic risdictional authority is divided not only within the federal resources for scientific purposes . The chapter includes a ( national ) government , but also among the ï?? ï?? individual discussion of the development of the first bioprospecting states . Within the federal government alone , lands and benefit - sharing agreement in the ï쳌µ ï쳌³ ï쳌¡ , which involved associated biological resources may be managed by any Yellowstone and the Diversa Corporation of San Diego , one of a wide range of departments ( such as Interior , California , and concludes with information about possible Agriculture , and Energy ) and separate agencies within future developments relating to genetic resource manage - departments ( such as the Bureau of Land Management , ment issues at Yellowstone and other ï쳌® ï쳌° ï쳌³ units . the Fish and Wildlife Service , the ï쳌µ ï쳌³ ï쳌¡ Geological Survey , While the ï쳌µ ï쳌³ ï쳌¡ still has not ratified the ï쳌£ ï쳌¢ ï쳌¤ , much of and the National Park Service â?? all within the Department the biological resource management experience reflected of the Interior ) . In addition , access to genetic resources that in the ï쳌® ï쳌° ï쳌³ is very consistent with the main conservation have been isolated by a laboratory or other institutional principles provided in the ï쳌£ ï쳌¢ ï쳌¤ . In April ï?? ï?? ï?? ï?? , the Sixth research entity may be subject to certain contractual ar - Conference of the Parties to the ï쳌£ ï쳌¢ ï쳌¤ meeting in The rangements such as biological material transfer agreements Hague adopted a set of voluntary guidelines specifically 3 or commercial use licenses , which may or may not be concerning access and benefit - sharing issues . Much of standardized . There also are several ex situ culture col - the voluntary guidelines concern pragmatic approaches lections located in the ï쳌µ ï쳌³ ï쳌¡ ( including the American Type to issues relating to prior informed consent ( ï쳌° ï쳌© ï쳌£ ) and mu - Culture Collection ( ï쳌¡ ï쳌´ ï쳌£ ï쳌£ ) , which is often described as tually agreed terms as they pertain to access and benefit 1 the worldâ??s largest ) . In all cases , however , the first step sharing . is to determine who is in charge of the resources and to While a section - by - section analysis is beyond the 4 ascertain precisely what is expected or required to obtain scope and purpose of this chapter , it should be noted 2 legitimate access . that the research specimen collection permit require - In light of this complexity â?? and in order to present an ments developed and implemented by the ï쳌® ï쳌° ï쳌³ provide illustrative example of genetic resource management in the an excellent example of how many of the concerns as - ï쳌µ ï쳌³ ï쳌¡ that takes a more national approach â?? this chapter will sociated with ï쳌° ï쳌© ï쳌£ can be very pragmatically addressed . focus on perhaps the most instructive case study arising in Likewise , although ï쳌® ï쳌° ï쳌³ is currently conducting a study the ï쳌µ ï쳌³ ï쳌¡ concerning both access and benefit - sharing issues . of the potential environmental impacts of implementing Specifically , the case study provides a detailed overview various benefit - sharing approaches throughout the ï쳌® ï쳌° ï쳌³ , of the background , experience , and status of genetic the issues under study also reflect many of the concerns resource management in ï쳌µ ï쳌³ ï쳌¡ national parks , with focus associated with â?? mutually agreed terms â?쳌 that are included on the particularly illustrative experience at Yellowstone in the voluntary guidelines . While no single national expe - National Park ( ï쳌¹ ï쳌® ï쳌° ) . rience can respond to or satisfy the interests and needs of a The chapter begins with an overview of the diversity very diverse world , the ï쳌® ï쳌° ï쳌³ experience may provide some of ecosystems protected by the ï쳌µ ï쳌³ ï쳌¡ National Park Service instructive examples about ways to implement many of the ( ï쳌® ï쳌° ï쳌³ ) and the fundamental natural resource management biodiversity conservation management principles that the principles they use . The ï쳌® ï쳌° ï쳌³ experience has important na - international community is continuing to refine â?? a very tionwide relevance inasmuch as ï쳌® ï쳌° ï쳌³ protects and manages long - term work - in - progress . National Parks as Living Laboratories than two percent of the total land area of the ï쳌µ ï쳌³ ï쳌¡ . Because Background of the importance attached to their relatively intact repre - The ï쳌µ ï쳌³ ï쳌¡ National Park Service comprises more than ï?? ï?? ï?? sentative diversity , the ecosystems protected and managed separate protected areas in every state of the ï쳌µ ï쳌³ ï쳌¡ ( except by the ï쳌® ï쳌° ï쳌³ are of increasing interest to researchers and are 5 Delaware ) plus the District of Columbia , American Samoa , often described as living laboratories . Guam , Puerto Rico , and theVirgin Islands , and encompass - Access to genetic resources found in ï쳌µ ï쳌³ ï쳌¡ national es approximately ï?? ï?? . ï?? million ha . Taken together , these parks is managed by ï쳌® ï쳌° ï쳌³ , a federal agency within the ï쳌µ ï쳌³ ï쳌¡ areas protect examples of virtually every type of ecosystem Department of the Interior . ï쳌® ï쳌° ï쳌³ was created by the ï쳌µ ï쳌³ ï쳌¡ found in NorthAmerica , even though these areas cover less Congress in ï?? ï?? ï?? ï?? specifically to ï?? ï?? ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : USA promote and regulate the use of the federal areas known tected areas of volcanism , hot water phenomena , mountain as national parks , monuments , and reservations â?¦ by systems , and mesas . such means and measures as conform to the fundamental The largest national park in the ï쳌µ ï쳌³ ï쳌¡ is Wrangell - St . purpose of the said parks , monuments , and reservations , Elias National Park and Preserve in Alaska . At ï?? . ï?? million which purpose is to conserve the scenery and the natu - ha , it makes up ï?? ï?? . ï?? % of the entire system . The largest ral and historic objects and the wild life therein and to unit in the ï?? ï?? contiguous states is Yellowstone National provide for the enjoyment of the same in such manner Park , comprising ï?? . ï?? million ha . The smallest unit in the and by such means as will leave them unimpaired for the 6 system is Thaddeus Kosciuszko National Memorial in enjoyment of future generations . Pennsylvania , comprising only ï?? . ï?? ï?? ï?? ha In order to understand how ï쳌® ï쳌° ï쳌³ approaches the issues of access to and use of ï쳌µ ï쳌³ ï쳌¡ national parks , it is important Genetic Resource Diversity and to understand ï쳌® ï쳌° ï쳌³ â?? overall natural resource management Management at Yellowstone standard . While the ï쳌µ ï쳌³ ï쳌¡ Congress has given ï쳌® ï쳌° ï쳌³ broad management discretion to allow certain impacts within Generally recognized as Americaâ??s ( and the worldâ??s ) parks , that discretion is limited by the statutory require - first national park , ï쳌¹ ï쳌® ï쳌° was created by an act of the ï쳌µ ï쳌³ ï쳌¡ ment that ï쳌® ï쳌° ï쳌³ must leave park resources and values unim - 9 Congress that was signed into law by President Ulysses paired to ensure they will continue to exist in a condition S . Grant on ï?? March ï?? ï?? ï?? ï?? . It is located in the northern that will allow present and future generations opportunities Rocky Mountain region of the ï쳌µ ï쳌³ ï쳌¡ in the northwest corner to enjoy them . of Wyoming with territory overlapping into Montana to The enjoyment of national park resources contemplated the north and Idaho to the west . by ï쳌® ï쳌° ï쳌³ is broad and includes deriving benefit ( including Yellowstone remains the largest national park in the scientific knowledge ) . However , ï쳌® ï쳌° ï쳌³ has explained that by continental ï쳌µ ï쳌³ ï쳌¡ outside Alaska . It covers ï?? , ï?? ï?? ï?? km ² ap - recognizing that the enjoyment of national parks by future proximately ï?? . ï?? million ha ) , which is larger than the generations can be ensured only if the superb quality of states of Rhode Island and Delaware combined . Its ter - park resources and values is left â?? unimpaired â?쳌 , conserva - rain includes ï?? , ï?? ï?? ï?? - meter peaks and high plateaus ; deep tion of park resources is to be predominant when there is canyons and broad sweeping valleys ; lakes , rivers , and a conflict between conserving resources and values and waterfalls ; and a variety of archeological and cultural 7 providing for enjoyment of them . sites . Yellowstone also is surrounded by wilderness areas ï쳌® ï쳌° ï쳌³ works to maintain as parts of the natural ecosys - protected by six national forests , Grand Teton National 8 tems found in national parks all native plants and animals Park , and two national wildlife refuges . and the full range of genetic types of native plant and ani - ï쳌¹ ï쳌® ï쳌° forms the core of the Greater Yellowstone mal populations . In carrying out this over - arching natural Ecosystem , considered the largest remaining intact eco - resource management approach , ï쳌® ï쳌° ï쳌³ aims to maintain all system in Earthâ??s temperate zone . In view of its ecologi - the components and processes of naturally evolving park cal significance , Yellowstone was declared a Biosphere ecosystems , including the natural abundance , diversity , and Reserve under the ï쳌µ ï쳌® ï쳌¥ ï쳌³ ï쳌£ ï쳌¯ Man and the Biosphere Program genetic and ecological integrity of the plant and animal in ï?? ï?? ï?? ï?? and was designated as a World Heritage Site by species native to those ecosystems . the United Nations in ï?? ï?? ï?? ï?? . Accordingly , the way that ï쳌® ï쳌° ï쳌³ manages access to Yellowstone protects vital habitats for a variety of national park resources ( including genetic resources ) is wildlife , including bison , grizzly and black bears , moose , based on the agencyâ??s fundamental duty to conserve na - elk , bighorn sheep , eagles , cutthroat trout , and several en - tional parks in an unimpaired condition for the enjoyment dangered or threatened species , including the gray wolf . ( broadly interpreted ) of present and future generations . Yellowstone is the only area of its size in the ï?? ï?? contiguous states that has never been farmed or fenced , and it remains Diversity of National Park Resources the only place in the ï쳌µ ï쳌³ ï쳌¡ where continuously free - ranging wild bison have survived since prehistoric times . With the The diversity of land ecosystems protected and managed restoration of the gray wolf to the park in the mid - ï?? ï?? ï?? ï?? s , by ï쳌® ï쳌° ï쳌³ includes tundra , boreal forest , Pacific forest , dry co - Yellowstoneâ??s ecosystem now includes all members of the niferous forest , eastern deciduous forest , grassland , chap - mammalian biotic community that were present in the area arral , and deserts . Tropical ecosystems are found in ï쳌µ ï쳌³ ï쳌¡ at the time when Europeans first arrived in America . national parks in Hawaii and the southern tip of Florida , Yellowstone also is a volcanic â?? hot spot â?쳌 located in Puerto Rico and the ï쳌µ ï쳌³ ï쳌¡ Virgin Islands , and American part of the most seismicly active region of the Rocky Samoa and Guam . ï쳌® ï쳌° ï쳌³ - protected tropical ecosystems Mountains . Underground magma which formed an im - include lowland rain forest , summer - deciduous forest , mense caldera approximately ï?? ï?? kilometers wide and ï?? ï?? swamp and mangrove formations , as well as montane kilometers long still provides the heat for the parkâ??s famous rainforest . Aquatic ecosystems protected in ï쳌µ ï쳌³ ï쳌¡ national thermal features that are an important part ofYellowstoneâ??s parks are as diverse as the land ecosystems , and include ecosystem . marine environments , estuaries , underground systems , lakes and ponds , and streams . ï쳌® ï쳌° ï쳌³ units also include pro - There are approximately ï?? ï?? , ï?? ï?? ï?? thermal features ï?? ï?? ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ at ï쳌¹ ï쳌® ï쳌° â?? the single greatest concentration on Earth . elsewhere , by the early ï?? ï?? ï?? ï?? s it was believed that the optimum temperature limit for thermophilic bacteria was Yellowstoneâ??s most charismatic thermal features are well ï?? ï?? ° C , while the upper temperature limit for life was ï?? ï?? ° C known by names such as Old Faithful , Excelsior , Morning ( K ï쳌¥ ï쳌­ ï쳌° ï쳌® ï쳌¥ ï쳌² ï?? ï?? ï?? ï?? ) . Glory , and Grand Prismatic , but the overwhelming major - In the mid - ï?? ï?? ï?? ï?? s , Professor Thomas Brock , who was ity of the parkâ??s thermal features are still unnamed and then working at Indiana University , undertook a series of unexplored . Taken together , Yellowstoneâ??s hot springs , studies on the distribution of photosynthetic microorgan - geysers , fumaroles , and mud pots comprise one of the isms in the thermal gradients that flowed gently out of worldâ??s most intriguing but still largely unexplored bio - several hot springs at Yellowstone . During his studies , logical habitats . Brock observed that while the upper temperature limit of Yellowstone and other ï쳌µ ï쳌³ ï쳌¡ national parks have cooper - photosynthetic life clearly appeared to be around ï?? ï?? ° C , ated and worked to support scientific activities involving there was evidence of life in the flow of some springs park resources since the ï?? ï?? th century . In August ï?? ï?? ï?? ï?? , the where the water was much hotter . At Octopus Spring , first research permit was issued at Yellowstone to W.A . for example , Brock observed pink filaments alive with Setchell from the University of California at Berkeley . The bacteria in waters with temperatures ranging as high as permit â?? written on a sheet of stationary from Mammoth ï?? ï?? ° C ( dramatically suggesting the existence of life above Hot Springs Hotel and authorized by Captain James B . the commonly accepted upper temperature limit ) ( B ï쳌² ï쳌¯ ï쳌£ ï쳌« Erwin of the ï쳌µ ï쳌³ ï쳌¡ Cavalry , which then was administering ï?? ï?? ï?? ï?? ) . This simple observation opened the door to the pos - Yellowstone â?? authorized Setchell â?? to collect and carry sibility that other types of nonphotosynthetic organisms away such specimens of algous [ sic ] growth as he may might be discovered alive at Yellowstone at temperatures deem necessary to carry out the investigation for which he 10 and in conditions previously unknown to support life . is now visiting the Yellowstone National Park â?쳌 . On ï?? September ï?? ï?? ï?? ï?? , Brock collected a sample of A century later , the parkâ??s thermal features are increas - bacteria from Yellowstoneâ??s Mushroom Spring which ingly recognized as providing rare habitat for many new he subsequently isolated , cultured , and named Thermus forms of microscopic life only recently discovered â?? life aquaticus . Brock identified the culture of T . aquaticus as too small to see outside of their sometimes richly colored ï쳌¹ ï쳌´ â?? ï?? . While Brockâ??s cultures of T . aquaticus grew best at colonies ( or â?? mats â?쳌 ) , but reflecting biological diversity that around ï?? ï?? ° C , cultures also grew at temperatures as high rivals the tropical rainforests and thrives in habitats once as ï?? ï?? ° C ( clearly surpassing the previously assumed upper - thought far too extreme to allow life to exist . temperature - limit of ï?? ï?? ° C ) ( B ï쳌² ï쳌¯ ï쳌£ ï쳌« ï?? ï?? ï?? ï?? ) . Like the early explorers , many of the contemporary Significantly , Brockâ??s observations of T . aquaticus scientific researchers at Yellowstone remain interested in were not limited just to temperature or other environmental the discovery of new forms of life and in the valuable in - factors . Laboratory analyses also led to new observations formation associated with such research . While Lewis and about the organismâ??s characteristics . For example , Brock Clark identified ï?? ï?? ï?? new plants and ï?? ï?? ï?? new animals never knew that most of the heat - loving bacteria that had been before seen by inhabitants of European origin from east of described by earlier researchers belonged to a group of the Mississippi during their historic ï?? ï?? ï?? ï?? â?? ï?? ï?? ï?? ï?? expedition , spore - forming bacteria that produced heat - resistant spores . the discovery of new life continues in unexpected places Brockâ??s studies of T . aquaticus revealed that the organism like Yellowstoneâ??s hot springs that were first described did not produce spores . This suggested that T . aquaticus by the early ï?? ï?? th century explorers as places where â?? Hell was some form of life that had not been discovered previ - bubbled up â?쳌 . With tools of science not available to ï?? ï?? th and ously . Based on taxonomic methods , Brock concluded that earlier ï?? ï?? th century explorers of the area , contemporary it was a member of a genus of organisms not previously scientific researchers are beginning to open windows on known to science ( B ï쳌² ï쳌¯ ï쳌£ ï쳌« and F ï쳌² ï쳌¥ ï쳌¥ ï쳌º ï쳌¥ ï?? ï?? ï?? ï?? ) . the heretofore unexplored microbiological worlds found The discovery , isolation , and culturing of T . aquaticus among the ï?? ï?? , ï?? ï?? ï?? thermal features at Yellowstone . at Yellowstone effectively lifted the lid on human under - standing ( and curiosity ) about the upper temperature Discovery of Thermus aquaticus limits of life . Thereafter , Brock identified the existence Much of the first ï?? ï?? ï?? years of research on thermophilic of an abundance of previously unknown microscopic life ( heat - loving ) life atYellowstone tended to focus on trying in boiling waters at Yellowstone ( water boils at ï?? ï?? . ï?? ° C at to identify the upper temperature limits of different forms Yellowstone because of the altitude ) . With a microscope , of life , and much of that research was based on what could he was able to see bacteria alive on glass slides that had be seen by the naked eye . The early â?? color - temperature â?쳌 been immersed in hot springs located in various places correlation observations of some ï?? ï?? th century scientists throughout the park . working at Yellowstone were being refined throughout While observations dating back to the ï?? ï?? th century the ï?? ï?? th century by observations made by many other suggested that the colorful formations surrounding many scientists working with the benefit of accumulated data thermal features at Yellowstone indicated the presence of and increasingly sophisticated equipment . For example , life , Brockâ??s discovery of life too small to see in waters too as a result of these ongoing studies at Yellowstone and hot to touch confirmed that the diversity of life protected by ï?? ï?? ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : USA predict when , where , and to whom the returns will eventu - the park ( but still unexplored ) was far greater than anyone ally accrue . Yet even work that can seem highly abstract had imagined . Since the discovery of T . aquaticus in ï?? ï?? ï?? ï?? , can have surprisingly immediate impacts . To take just one many other previously unknown organisms have been dis - example , in ï?? ï?? ï?? ï?? Thomas Brock , a microbiologist at the covered thriving in Yellowstoneâ??s thermal environments . University of Wisconsin , discovered a form of bacteria Some scientists now estimate that perhaps less than one in the thermal vents of Yellowstone that can survive at percent of all the organisms living inYellowstoneâ??s thermal very high temperature . From these bacteria an enzyme features have been discovered and identified to date . was extracted that is stable at near - boiling temperatures . Nearly two decades later this enzyme proved to be vital Taq and PCR in the process known as the polymerase chain reaction , which is used to duplicate specific pieces of DNA . Today , In the ï?? ï?? ï?? ï?? s , scientists from the Cetus Corporation were PCR is the basis of a multimillion dollar business with conducting research on ways to replicate ï쳌¤ ï쳌® ï쳌¡ . Their work applications ranging from the rapid diagnosis of disease 13 to forensic medicine . ultimately resulted in development of the polymerase chain reaction ( ï쳌° ï쳌£ ï쳌² ) . A polymerase is an enzyme that replicates The success associated with Taq was coupled with ad - ï쳌¤ ï쳌® ï쳌¡ . By incorporating the ï쳌¤ ï쳌® ï쳌¡ - copying activity of the ditional reports of other important biological discoveries polymerase , ï쳌° ï쳌£ ï쳌² permits the duplication of batches of ï쳌¤ ï쳌® ï쳌¡ at Yellowstone . The more scientists learned , the more it from only tiny samples , a development so important to appeared that the extreme environments characterized by science that its discoverers were awarded a Nobel Prize . Yellowstoneâ??s thermal features comprised a hothouse full Now , ï쳌° ï쳌£ ï쳌² is used in a host of important applications rang - of undiscovered microorganisms with many new poten - ing from diagnosing diseases to identifying criminals from tially valuable uses precisely because of their ability to their ï쳌¤ ï쳌® ï쳌¡ fingerprints . withstand such extreme conditions ( M ï쳌¡ ï쳌² ï쳌² ï쳌³ and M ï쳌¡ ï쳌¤ ï쳌© ï쳌§ ï쳌¡ ï쳌® The early ï쳌° ï쳌£ ï쳌² experiments were not satisfactory , ï?? ï?? ï?? ï?? ) . Although there was no definitive comprehensive however , because the polymerase that was being used report of all of the valuable discoveries associated with by the Cetus scientists was unable to withstand the heat research involving Yellowstoneâ??s microbial resources , required by the ï쳌° ï쳌£ ï쳌² process . The researchers theorized that some journalists reported multiple applications that in - perhaps a thermophilic microorganism could produce a cluded development of new bioremediation technologies , thermostable enzyme that could tolerate the heat used in â?? clean â?쳌 fuels research , and uses involving paper , textiles , the ï쳌° ï쳌£ ï쳌² process and thereby fix the problem . Accordingly , 14 and plastics . Other potentially valuable applications also they ordered samples of T . aquaticus ( ï쳌¹ ï쳌´ â?? ï?? ) from the ï쳌¡ ï쳌´ ï쳌£ ï쳌£ were sometimes identified in scientific papers relating to that had been collected at Yellowstone and deposited by the initial discovery , identification , and isolation of new Brock approximately ï?? ï?? years earlier . microorganisms at Yellowstone . Taken together , these From a sample of the ï쳌¹ ï쳌´ â?? ï?? culture of T . aquaticus , developments suggested that Yellowstone ranked as high the Cetus scientists identified and isolated a heat - stable as some other celebrated environments as a source of still enzyme that they named Taq polymerase . Subsequently , undiscovered valuable biological information . they discovered that incorporating the Taq polymerase into As a result of the research interest in the biological the ï쳌° ï쳌£ ï쳌² process satisfactorily fixed the â?? overheating â?쳌 prob - materials being discovered inYellowstoneâ??s extreme ther - lem , which meant that the ï쳌° ï쳌£ ï쳌² process could efficiently mal environments , the park was asked by the Director of replicate ï쳌¤ ï쳌® ï쳌¡ as desired . ï쳌µ ï쳌³ ï쳌¡ patents were awarded to the the National Park Service to explore development of a scientists in ï?? ï?? ï?? ï?? on Taq polymerase and in ï?? ï?? ï?? ï?? on the pilot â?? benefit - sharing â?쳌 program . Such a program would 11 ï쳌° ï쳌£ ï쳌² process . supplement permitted research use of research specimens The value of the ï쳌° ï쳌£ ï쳌² process was quickly recognized , collected at the park ( with special focus on developing and in ï?? ï?? ï?? ï?? the patent rights were acquired by the phar - and implementing a cooperative research mechanism maceutical firm Hoffmann - LaRoche for a sum widely re - that would allow the park to benefit from any valuable 12 ported to be in excess of ï?? ï?? ï?? ï?? million ï쳌µ ï쳌³ ï쳌¤ . Subsequent discoveries resulting from research activities involving revenues earned by Hoffmann - LaRoche from licensing specimens already lawfully collected at ï쳌¹ ï쳌® ï쳌° ) . The ï쳌® ï쳌° ï쳌³ rights to the use of ï쳌° ï쳌£ ï쳌² technology are estimated in excess Director asked Yellowstone to take this action because of of ï?? ï?? billion ï쳌µ ï쳌³ ï쳌¤ and growing . public perceptions ( fueled in large measure by media re - The importance of the research involving T . aquati - ports ) that private sector entities were enjoying substantial cus and the Taq polymerase was summarized in ï?? ï?? ï?? ï?? in economic and scientific benefits from research involving Congressional testimony offered by D . Allan Bromley Yellowstone resources without sharing those benefits for ( then Director of the White House Office of Science the conservation of the park . and Technology Policy and Science Advisor to President Not unlike the early ï?? ï?? th century explorers who were George H.W . Bush ) : amazed by the rich diversity of megafauna such as bear , elk , and bison found in theYellowstone area , the recent and Different kinds of research and development tend to have ongoing discovery of previously unknown microscopic life different kinds of returns . With basic research â?? the ma - forms in Yellowstoneâ??s hot springs has sparked a renais - jority of which is done by individual scientists and small groups of scientists at universities â?? it is very difficult to sance of scientific interest in the park . The rich diversity ï?? ï?? ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ of previously unknown life at Yellowstone is presenting for conserving the parkâ??s valuable biological diversity , important new opportunities to manage scientific research Yellowstone is exploring ways that it can strengthen re - activities that require access to genetic resources found at search so that it also will rebound benefits to the park for the park . By linking scientific and economic incentives sustainable resource conservation . associated with research activities with other incentives The Value of Biological Research and the Law As knowledge and the tools of science have advanced , so the Courtâ??s interpretation of the language of the patent too has the range of scientific inquiry atYellowstone . When statute . Commencing with a review of the legislative his - Professor Brock visited Yellowstone in the early - ï?? ï?? ï?? ï?? s , tory of the Patent Act of ï?? ï?? ï?? ï?? that was drafted by Thomas the definitive upper temperature limit of life was widely Jefferson , the Court noted that the patent law defined pat - believed to be ï?? ï?? ° C . Brock and his team of researchers entable statutory subject matter as â?? any new and useful at Yellowstone , however , were making observations that art , machine , manufacture , or composition of matter , or 17 suggested that some forms of life appeared to thrive at any new or useful improvement [ thereof ] â?쳌 and reflected higher temperatures â?? observations that ultimately led to Jeffersonâ??s view that â?? ingenuity should receive a liberal 18 the discovery of T . aquaticus . encouragement â?쳌 . It is simple to see that the more detail that Brock and From the Courtâ??s rationale , the focus of relevant his team learned about the newly discovered organism , inquiry for purposes of determining whether something the greater would be the value associated with their dis - â?? biological â?쳌 qualifies as patentable â?? subject matter â?쳌 under coveries and ongoing research program . The term â?? value â?쳌 Section ï?? ï?? ï?? of the ï쳌µ ï쳌³ ï쳌¡ patent statute is shifted away from does not necessarily imply monetary or economic value . the simple question , â?? Is it living ? â?쳌 Instead , the Courtâ??s Discoveries as significant as T . aquaticus generally help a rationale in Chakrabarty placed controlling emphasis on researcherâ??s appeals for funding and other support , often whether the living matter is the result of the intervention simply as part of the natural fall - out of a successful project . of human ingenuity and creativity . Nonetheless , it was the connection between the discoveries The Court noted that Mr . Chakrabarty had â?? produced associated with the isolation of the Taq polymerase and its a new bacterium with markedly different characteristics utility in the ï쳌° ï쳌£ ï쳌² process that generated the multimillion from any found in nature and one having the potential dollar revenues that in turn generated the headline - making for significant utility â?¦ not natureâ??s handiwork , but his 15 19 news . Typically , economic value attaches to discoveries own â?쳌 . Therefore , the Court ruled , â?? it is patentable sub - 20 that have some â?? useful â?쳌 application in human society ; the ject matter â?쳌 under Section ï?? ï?? ï?? of the ï쳌µ ï쳌³ ï쳌¡ patent statute . use of Taq in the development of ï쳌° ï쳌£ ï쳌² technology is but one Elsewhere , still focusing on legislative intent , the Court of countless examples . Likewise , value rarely attaches to reemphasized : â?? Congress thus recognized that the relevant discoveries or other forms of creativity that simply are not distinction was not between living and inanimate things , useful in human society . but between products of nature , whether living or not , and 21 The value of such discoveries in biological research human - made inventions â?쳌 . was recognized ( and effectively amplified ) by a landmark The ï쳌µ ï쳌³ ï쳌¡ Supreme Courtâ??s ruling in Chakrabarty ruling of the ï쳌µ ï쳌³ ï쳌¡ Supreme Court in ï?? ï?? ï?? ï?? . The case con - paved the way under the existing ï쳌µ ï쳌³ ï쳌¡ patent statute for cerned the question of whether inventions that relate to new patent claims on biological â?? inventions , â?쳌 which in certain â?? living things â?쳌 are eligible for protection under the turn accelerated development of the economic benefits 22 ï쳌µ ï쳌³ ï쳌¡ patent law . While the scientific value of advancing de - that attach to useful patented discoveries . The Courtâ??s velopments in biological research was clearly recognized rationale also emphasized that the â?? value â?쳌 in biological and not in dispute , the issue of whether the economic value discoveries recognized and protected by the patent statute that attaches to inventions as a result of patent protection resides in beneficial research results , not in naturally occur - turned on the Courtâ??s decision . In retrospect , the case is ring phenomena â?? free to all men and reserved exclusively 23 seen as having provided the legal foundation for the phe - to none â?쳌 . nomenal growth and development of the biotech industry Applying the rule announced by the Court in Chakra - in the ï쳌µ ï쳌³ ï쳌¡ since the early ï?? ï?? ï?? ï?? s . barty , the ï쳌µ ï쳌³ ï쳌¡ Patent and Trademark Office ( ï쳌µ ï쳌³ ï쳌° ï쳌´ ï쳌¯ ) has The case ( Diamond v . Chakrabarty ) concerned a patent explained that â?? it is clear from the Supreme Court decision application filed in ï?? ï?? ï?? ï?? by a microbiologist who asserted and opinion that the question of whether or not an invention ï?? ï?? claims related to a genetically engineered â?? bacterium embraces living matter is irrelevant to the issue of patent - from the genus Pseudomonas containing therein at least ability â?쳌 , emphasizing that â?? the test set down by the Court two stable energy - generating plasmids , each of said for patentable subject matter in this area is whether the 24 plasmids providing a separate hydrocarbon degradative living matter is the result of human intervention â?쳌 . 16 pathway â?쳌 . The Courtâ??s ruling in Chakrabarty , which ï쳌µ ï쳌³ ï쳌° ï쳌´ ï쳌¯ also has explained that it â?? will decide the ques - held that a human - made living microorganism is patent - tions as to patentable subject matter under ï?? ï?? ï쳌µ ï쳌³ ï쳌£ ï?? ï?? ï?? on able subject matter under ï쳌µ ï쳌³ ï쳌¡ patent law , was based on a case - by - case basis following the tests set forth in Chak - ï?? ï?? ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : USA 28 rabarty , e.g . , that â?? a nonnaturally occurring manufacture then leapt to ï?? ï?? ï?? in ï?? ï?? ï?? ï?? . Similar trends occurred in Class ï?? ï?? ï?? ( â?? Chemistry : Molecular Biology and Microbiology â?쳌 ) or composition of matter â?? is patentable , etc . â?쳌 , emphasiz - even though substantially more Class ï?? ï?? ï?? patents already ing that â?? it is inappropriate to try to attempt to set forth were being approved before Chakrabarty . In ï?? ï?? ï?? ï?? , the ï쳌µ ï쳌³ ï쳌¡ here [ ï쳌µ ï쳌³ ï쳌° ï쳌´ ï쳌¯ policy guidance on patentability of living Supreme Court also ruled that plant varieties are eligible subject matter ] in advance of the exact parameters to be 25 for protection by utility patents issued pursuant to ï?? ï?? ï쳌µ ï쳌³ ï쳌£ followed â?쳌 . ï?? ï?? ï?? , as well as under the Plant Patent Act of ï?? ï?? ï?? ï?? ( ï?? ï?? ï쳌µ ï쳌³ ï쳌£ Not surprisingly , the number of patents pertaining ï?? ï?? ï?? et seq . ) and the Plant Variety Protection Act of ï?? ï?? ï?? ï?? to â?? living subject matter â?쳌 approved by the ï쳌µ ï쳌³ ï쳌° ï쳌´ ï쳌¯ in - 29 ( ï?? ï쳌µ ï쳌³ ï쳌£ ï?? ï?? ï?? ï?? et seq . ) . creased dramatically after the Supreme Courtâ??s ruling The distinction between what the law rewards ( new , in Chakrabarty . For example , only one patent was ap - useful , and nonobvious discoveries based on research re - proved by ï쳌µ ï쳌³ ï쳌° ï쳌´ ï쳌¯ in ï?? ï?? ï?? ï?? ( the year before the ruling in sults ) and what the law protects ( naturally occurring life Chakrabarty ) for a Class ï?? ï?? ï?? invention ( â?? Multicellular forms that remain free for all to use ) is at the core of the Living Organisms and Unmodified Parts Thereof and 26 biodiversity prospecting access and benefit - sharing issues Related Processes â?쳌 ) . A decade later , ï?? ï?? Class ï?? ï?? ï?? pat - 30 27 first pioneered in the ï쳌µ ï쳌³ ï쳌¡ at Yellowstone . ents were approved . By ï?? ï?? ï?? ï?? , the number had increased dramatically to ï?? ï?? ï?? , after which it rose to ï?? ï?? ï?? in ï?? ï?? ï?? ï?? and NPS Genetic Resource Access Management The search for potentially useful biological compounds in however , requires clear focus on the two sets of core is - Nature ( sometimes popularly referred to as â?? biodiversity sues that relate to biodiversity prospecting : access and prospecting â?쳌 or â?? bioprospecting â?쳌 ) involves two distinct benefit sharing . sets of issues : access to biological resources and benefit sharing . Issues relating to access concern the terms and Access conditions associated with collection and sampling of bio - Access to the biological resources of ï쳌µ ï쳌³ ï쳌¡ national parks logical research specimens . These issues also may relate for research purposes is governed by ï쳌® ï쳌° ï쳌³ regulations . to the purpose underlying collection and sampling , or to The ï쳌® ï쳌° ï쳌³ research specimen collection permit regulations how the research specimens are to be used . Issues relating have been implemented since ï?? ï?? ï?? ï?? , and permits for the to benefit sharing concern the terms and conditions under collection of research specimens throughout the ï쳌® ï쳌° ï쳌³ are which the provider of biological research specimens may be 32 issued routinely . Issuance of an ï쳌® ï쳌° ï쳌³ research specimen positioned to share in the beneficial results of research in - collection permit is based on a determination by a park su - volving biological specimens provided to a research user . perintendent that â?? public health and safety , environmental While research specimen collection and related sci - or scenic values , natural or cultural resources , scientific entific research activities in ï쳌µ ï쳌³ ï쳌¡ national parks certainly research , implementation of management responsibilities , is not new , the ï쳌µ ï쳌³ ï쳌¡ Congress enacted a law in ï?? ï?? ï?? ï?? that proper allocation and use of facilities , or the avoidance of mandated increased scientific research in the national conflict among visitor use activities will not be adversely parks and use of the results of scientific study in park 33 impacted â?쳌 by issuance of a permit . Based on public com - 31 management decisions . The new law encourages the ments filed at the time the regulations were promulgated , development of cooperative research initiatives between ï쳌® ï쳌° ï쳌³ concluded that these determinations are â?? adequate to individual national parks and scientific researchers ( public 34 ensure protection of park resources â?쳌 . as well as private ) , and mandates the integration of research A park superintendentâ??s express regulatory authority results into park management decisions . It also mandates to issue permits for the collection of research specimens development of long - term inventory and monitoring ac - ( with terms and conditions deemed necessary to protect tivities that provide baseline information and document park resources ) provides the mechanism for each ï쳌® ï쳌° ï쳌³ trends relating to the condition of resources protected by unit to govern access to its own biological resources for the national parks . Implementation of these new statutory research purposes . â?? Permit â?쳌 is defined under the regula - directives clearly can accelerate cooperative development tions to mean â?? a written authorization to engage in uses and management of the wealth of biological resource in - or activities that are otherwise prohibited , restricted , or formation flowing from Yellowstoneâ??s hot springs as well 35 regulated â?쳌 . The regulations also provide that a superin - as from other national parks . tendent â?? shall include in a permit the terms and conditions By linking scientific and economic incentives asso - that the superintendent deems necessary to protect park ciated with research activities with other incentives for 36 resources â?쳌 . Collection of any biological material in an conserving valuable biological diversity , research initia - ï쳌® ï쳌° ï쳌³ unit without a permit is strictly prohibited . tives can encourage sustainable resource conservation and ï쳌® ï쳌° ï쳌³ regulations provide that specimen collection management in accordance with the new mandates enacted permits by Congress in the National Parks Omnibus Management Act of ï?? ï?? ï?? ï?? . Effective implementation of these provisions , may be issued only to an official representative of a ï?? ï?? ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ reputable scientific or educational institution or a State â?¢ Is supported academically and financially , making or Federal agency for the purpose of research , baseline it highly likely that all fieldwork , analyses , and re - inventories , monitoring , impact analysis , group study , porting will be completed within a reasonable time or museum display when the superintendent determines 39 frame . that the collection is necessary to the stated scientific or resource management goals of the institution or agency ï쳌® ï쳌° ï쳌³ considers it â?? unfavorable â?쳌 for a permit review , if and that all applicable Federal and State permits have the proposed research been acquired , and that the intended use of the specimens â?¢ Involves activities that adversely affect the experi - and their final disposal is in accordance with applicable ences of park visitors ; 37 law and Federal administrative policies . â?¢ Shows potential for adverse impact on the parkâ??s The regulations do not discriminate against for - profit natural , cultural , or scenic resources , and particular - or other corporate research firms provided they engage in ly to nonrenewable resources such as archeological reputable scientific research activities . This reflects the and fossil sites or special - status species ( the entire reality that some of the very best science is practiced by range of adverse impacts that will be considered private corporations while some of the most entrepreneur - also includes construction and support activities , ial research activities are carried out by universities and trash disposal , trail conditions , and mechanized other academic institutions . equipment use in sensitive areas ) ; Permits are issued after a researcher has submitted a â?¢ Shows potential for creating high risk of hazard to permit application that provides the information required the researchers , other park visitors , or environments by the park and is deemed by the park superintendent to adjacent to the park ; be consistent with the parkâ??s mission , applicable regula - â?¢ Involves extensive collecting of natural materials tions ( particularly ï?? ï?? ï쳌£ ï쳌¦ ï쳌² ï?? . ï?? ) , and ï쳌® ï쳌° ï쳌³ policy . The permit or unnecessary replication of existing voucher application process helps ensure that the permit applicant collections ; discloses the information required to enable the park to â?¢ Requires substantial logistical , administrative , determine that the proposed research activities are consis - 38 curatorial , or project monitoring support by park tent with ï쳌® ï쳌° ï쳌³ regulations and policy ( Figure ï?? ) . staff , or provides insufficient lead time to allow In the review of applications for research projects , ï쳌® ï쳌° ï쳌³ necessary review and consultation ; considers it a â?? favorable â?쳌 characteristic if the proposed research â?¢ Is to be conducted by a principal investigator lacking scientific institutional affiliation and / or recognized â?¢ Contributes information useful to an increased un - experience conducting scientific research ; or derstanding of park resources , and thereby contrib - utes to effective management and / or interpretation â?¢ Lacks adequate scientific detail and justification to 40 of park resources ; support the study objectives and methods . â?¢ Provides for scheduled sharing of information with Currently , as part of the research permit terms , sci - park staff , including any manuscripts , publications , entists are required to submit a yearly summary of their maps , databases , etc . , which the researcher is will - park research activities , known as an Investigatorâ??sAnnual ing to share ; Report . In addition , copies of field notes and scientific â?¢ Addresses problems or questions of importance to publications may be required by the park . science or society and shows promise of making an Microbial research projects atYellowstone require ac - important contribution to humankindâ??s knowledge cess to the government - owned biological resources that are of the subject matter ; controlled by these research specimen permit regulations . â?¢ Involves a principal investigator and support team There have been approximately ï?? ï?? ï?? research projects per - with a record of accomplishments in the proposed mitted annually at Yellowstone since the mid - ï?? ï?? ï?? ï?? s that field of investigation and a demonstrated ability to cover a wide range of natural resource subjects . Not all work cooperatively and safely and to accomplish of these projects involve the collection of biological or the desired tasks within a reasonable time frame ; other natural resource samples from the park for research purposes . In ï?? ï?? ï?? ï?? , there were more than ï?? ï?? research â?¢ Provides for the investigator ( s ) to prepare occa - projects relating to thermophilic microbial resources at sional summaries of findings for public use , such Yellowstone that involved the issuance of research speci - as seminars and brochures ; men collection permits . â?¢ Minimizes disruption to the parkâ??s natural and Projects also benefit from cooperative guidance and cultural resources , park operations , and visitors ; data provided by the Yellowstone Center for Resources â?¢ Discusses plans for the cataloging and care of col - in connection with resource - relevant information for the lected specimens ; researcher . Researchers are frequently accompanied in the â?¢ Clearly anticipates logistical needs and provides field by Yellowstone staff , who monitor specimen collec - detail about provisions for meeting those needs ; or tion procedures and provide assistance on information ï?? ï?? ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : USA relevant to the specific research project . This assistance terms and conditions also specify that collected specimens 42 from the park often makes the best use of research time remain ï쳌® ï쳌° ï쳌³ property . and resources . Likewise , Yellowstone benefits from the There are several additional important standardized researchers â?? own research - relevant information ( some of research specimen collection permit terms and conditions which may be proprietary and protected by Federal intel - that relate specifically to access issues . First , the permits lectual property laws ) . provide that permittees shall comply with all applicable There is an important distinction between â?? sale or com - ï쳌® ï쳌° ï쳌³ and other federal and state laws and regulations , and mercial use â?쳌 of natural products collected from national that â?? [ n ] o specimens ( including materials ) may be col - parks ( which is prohibited under ï?? ï?? ï쳌£ ï쳌¦ ï쳌² ï?? . ï?? ( c ) ( ï?? ) ( v ) ) and lected unless authorized on the Scientific Research and 43 the discovery of valuable useful applications from â?? re - Collecting permit â?쳌 . Second , the permits prohibit unau - search results â?쳌 that could bring the park potential benefits thorized third - party transfers of any specimens collected , ( whether commercialized or not ) . The facts and circum - which effectively limits legitimate access to ï쳌® ï쳌° ï쳌³ resources stances surrounding permitted research atYellowstone and that have been collected to specifically authorized persons throughout the ï쳌® ï쳌° ï쳌³ system reflect this important distinc - only . Third , the permits require that â?? [ c ] ollection methods tion . This distinction also has been upheld as valid by the shall not attract undue attention or cause unapproved dam - 41 federal judiciary . Significantly , the standardized permit age , depletion , or disturbance to the environment and other 1 . ï쳌® ï쳌° ï쳌³ encourages researchers interested in natural 6 . The permit could be denied at this stage ( or resource or social science research in a unit of the recommendations for denial or acceptance could National Park System to submit an application be prepared for review ) . for a permit . 2 . The requestor obtains the application packet 7 . Assess proposal for potential impact under and related information that could affect the ï쳌® ï쳌¥ ï쳌° ï쳌¡ guidelines . Categorically exclude proposal researcher on the Internet at the web site listed or recommend that further analysis is required . below or by corresponding with the park in which the applicant wishes to work . Once a park has received a completed 8 . Consider total potential benefits against poten - application through the Internet or by tial impacts and risks . other means , park staff will : 3 . Establish a file of the application . 9 . Make recommendation to Superintendent or designee to approve or reject the permit request . 4 . Estimate the turn - around time for application review . Notify the applicant if the review is ex - pected to take longer than 90 days . 10 . If application approved , send permit and attached conditions ( including requirement for annual accomplishment report ) to applicant for 5 . Review application and proposal for : scientific signature . validity ; researcher and institutional qualifica - tions ; benefit to the park service and the public ; actual or potential impacts to park resources , visitor experiences , wilderness , safety , and other issues ; and possible need for other federal or state 11 . If application rejected , notify applicant of permits or approvals . Depending on the park and denial decision and identify reasons for denial . the content of the proposal , there may be various ( In most cases , an opportunity for revising and levels of review in the park and possible outside resubmitting the application is possible . ) peer review . Figure ï?? . ï쳌® ï쳌° ï쳌³ Standardized Review Procedures for Scientific Research and Collecting Permit Applications . The chart illustrates the general order of decision making and the major criteria used to accept or reject a permit application . The Internet - accessible ï쳌µ ï쳌³ ï쳌¡ National Park Service Research Permit and Reporting System webpage describes the review procedures in full detail ( http : / / science.nature.nps.gov / permits / index.html ) . The procedures were made standardized and Internet accessible in January ï?? ï?? ï?? ï?? . ï?? ï?? ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ 44 park resources , such as historic sites â?쳌 . Fourth , the per - cases can help minimize the demands for in situ sampling mits stipulate that research results derived from collected at the parks . specimens must be used for scientific and educational Historically , culture collections have distributed purposes only and may not be used commercially unless biological materials collected from Yellowstone without the permittee has entered into a Cooperative Research coordination with the park or the ï쳌® ï쳌° ï쳌³ . This situation has and Development Agreement ( ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ ) or other approved effectively allowed researchers from industry as well as 45 benefit - sharing agreement with the ï쳌® ï쳌° ï쳌³ . academia to circumvent ï쳌® ï쳌° ï쳌³ research specimen collection In addition to the regulations and specified permit terms regulations . It has also effectively removed the parks from and conditions , ï쳌® ï쳌° ï쳌³ policy concerning access to national any benefit - sharing opportunities . For example , the Cetus park resources is further articulated by the ï쳌® ï쳌° ï쳌³ Director . Corporation ( developer of the Nobel Prize â?? winning multi - The ï쳌® ï쳌° ï쳌³ Management Policies is the basic Service - wide million - dollar ï쳌° ï쳌£ ï쳌² technology ) acquired the now legendary policy document of the National Park Service , and is the sample of Yellowstoneâ??s T . aquaticus from ï쳌¡ ï쳌´ ï쳌£ ï쳌£ and not highest of three levels of guidance documents in the ï쳌® ï쳌° ï쳌³ directly from the park . Directives System . Interim updates or amendments may In the past , Yellowstone and other national parks have be accomplished through Directorâ??s Orders ( the second not been positioned to monitor or benefit from third - party level of the ï쳌® ï쳌° ï쳌³ Directives System ) , which also serve as a use of their natural resources acquired indirectly . ï쳌® ï쳌° ï쳌³ is vehicle to clarify or supplement ï쳌® ï쳌° ï쳌³ Management Policies evaluating steps to require culture collections to regulate to meet the needs of ï쳌® ï쳌° ï쳌³ managers . The most detailed and distribution of any biological materials collected from comprehensive guidance on implementing Service - wide national parks to ensure that all potential recipients un - policy is usually in the form of handbooks or reference derstand that their use of such samples must be in accord manuals issued by associate directors ( the third level of with the policies that govern use of samples collected di - the ï쳌® ï쳌° ï쳌³ Directives System ) . rectly from a national park . There also are opportunities for Instructions , guidance , and directives for regional or national parks to develop more substantive joint research otherwise limited application supplementary to and in activities with culture collections concerning discovery , conformance with Service - wide policies may be issued identification , and ex situ conservation of biological re - by regional directors or associate directors with formal sources that could be of benefit . delegations of authority . Superintendents may issue , within formal delegations of authority , park - specific instructions , Yellowstone - Diversa Agreement and procedures , directives , and other supplementary guidance Benefit Sharing ( such as permit terms and conditions ) , provided the guid - Despite the phenomenal success resulting from the ance does not conflict with Service - wide policy . chain of useful scientific discoveries that flowed directly Chapter ï?? of the ï?? ï?? ï?? ï?? ï쳌® ï쳌° ï쳌³ Management Policies back to the initial discovery by Brock of T . aquaticus in ( â?? Natural Resource Management â?쳌 ) provides that ï쳌® ï쳌° ï쳌³ Yellowstoneâ??s Mushroom Spring , Yellowstone never was â?? will preserve the natural resources , processes , systems , positioned to share any of the benefits that resulted from and values of units of the national park system in an un - the isolation of the Taq polymerase and its successful use impaired condition â?쳌 pursuant to the ï쳌® ï쳌° ï쳌³ Organic Act , the and development in ï쳌° ï쳌£ ï쳌² technology . Nonetheless , the dis - National Parks Omnibus Management Act of ï?? ï?? ï?? ï?? , the covery of T . aquaticus at Yellowstone , the identification National Environmental Policy Act ( ï쳌® ï쳌¥ ï쳌° ï쳌¡ ) , and other and isolation of the Taq polymerase , and the successful laws , and summarizes ï쳌® ï쳌° ï쳌³ policies relating to studies and 46 47 use of Taq in the development of ï쳌° ï쳌£ ï쳌² technology is one collections , independent studies , and collections as - 48 of the classic examples of the contemporary utility of bio - sociated with development of commercial products . In prospecting â?? the search for potentially useful biological addition , Chapter ï?? ( â?? Use of the Parks â?쳌 ) of the ï?? ï?? ï?? ï?? ï쳌® ï쳌° ï쳌³ compounds in nature . Management Policies provides that â?? [ s ] tudies , research , Several observers noted the parallels between and collection activities by non - ï쳌® ï쳌° ï쳌³ personnel involving Yellowstoneâ??s situation and the use of biological samples natural and cultural resources will be encouraged and fa - acquired from rainforests and other tropical habitats around cilitated when they otherwise comport with ï쳌® ï쳌° ï쳌³ policies â?쳌 , the world by many research firms . Not surprisingly , how - and that â?? [ s ] cientific activities that involve field work or ever , the large economic gains resulting from the success - specimen collection â?¦ require a permit issued by the ful research activities involving samples of T . aquaticus superintendent that prescribes appropriate conditions for 49 first acquired from Yellowstone prompted some alarming protecting park resources , visitors , and operations â?쳌 . 51 headlines such as â?? Industries Exploit First Park â?쳌 . The While it is illegal to collect any biological material most astute observers also noted that some of these places directly from a ï쳌µ ï쳌³ ï쳌¡ National Park without a proper per - 50 ( such as Costa Rica ) already were beginning to take steps mit , acquisition of samples from culture collections has to capture and reinvest some research benefits in ways that sometimes been attractive to researchers because they are would yield future conservation dividends . assured of obtaining â?? pure cultures â?쳌 ( albeit not directly As public awareness and interest in the issue grew , from a national park ) . Culture collections also can pro - vide an ex situ source for biological material that in some Yellowstone began to evaluate different ways by which ï?? ï?? ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : USA it might respond . Yellowstone staff convened a series of outlined in May ï?? ï?? ï?? ï?? in the handbook entitled Technology public meetings attended by National Park Service staff , Transfer : Marketing Our Products and Technologies ( A academic and industry researchers , conservation interests , Training Handbook for the ï쳌µ ï쳌³ Department of the Interior ) . and journalists . As a result of this ongoing evaluation of While the research specimen permits that are issued under the issue by Yellowstone staff , some opportunities for ï?? ï?? ï쳌£ ï쳌¦ ï쳌² ï?? . ï?? govern access to Yellowstoneâ??s biological re - initiating a pilot bioprospecting benefit - sharing project sources for research purposes , ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ s provide one type of began to emerge . In addition , the Director of the National framework that can be used to structure a benefit - sharing 55 Park Service also askedYellowstone in July ï?? ï?? ï?? ï?? to begin arrangement . Significantly , the ï?? ï?? ï?? ï?? Senate Report sug - to take some concrete steps that would position the park gests that the ï쳌µ ï쳌³ ï쳌¡ Congress believed when it enacted the to share in the benefits of research activities in a way ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ statute that prospective and unknown future benefits that would not chill research and that might serve as an associated with research activities ( which are particularly example for other parks facing the same issue . As with characteristic of bioprospecting activities ) are matters to so many other resource - related issues since its founding , be negotiated by the parties themselves : Yellowstone was presented with an historic conservation Often , collaboration between a laboratory and some opportunity . other organization can be expected to lead to future In response to the ï쳌® ï쳌° ï쳌³ Directorâ??s request , Yellowstone inventions . All parties should be clear on who will have evaluated use of the Department of the Interiorâ??s estab - what rights to future inventions when the work begins . lished guidelines for negotiation of ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ s to address the This amendment [ codified at ï?? ï?? USC § ï?? ï?? ï?? ï?? a ( b ) ( ï?? ) ] al - benefit - sharing issue . A ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ is defined by the Federal lows Federal laboratories to assign rights in future inven - tions to the cooperating , outside parties . It is anticipated Technology Transfer Act ( ï쳌¦ ï쳌´ ï쳌´ ï쳌¡ ) of ï?? ï?? ï?? ï?? as â?? any agree - that agencies will normally retain for the Government a ment between one or more Federal laboratories and one paid license to use or have future inventions used in the or more non - Federal parties under which the Government , 56 Governmentâ??s behalf . through its laboratories , provides personnel , services , On ï?? ï?? August ï?? ï?? ï?? ï?? , Yellowstone announced that it had facilities , equipment or other resources with or without reached agreement on a bioprospecting benefit - sharing ar - reimbursement ( but not funds to non - Federal parties ) and rangement with Diversa Corporation , an enzyme discovery the non - Federal parties provide funds , personnel , services , firm headquartered in San Diego , California . The agree - facilities , equipment , or other resources toward the conduct ment was reviewed by the ï쳌® ï쳌° ï쳌³ Director and finalized in of specified research or development efforts which are 52 May ï?? ï?? ï?? ï?? ( Box ï?? ) . This first ever bioprospecting benefit - consistent with the mission of the laboratory â?쳌 . By enter - sharing agreement involving a national park in the ï쳌µ ï쳌³ ï쳌¡ ing into a ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ , Federal and non - Federal partners can positioned Yellowstone to share in future economic and optimize their mix of resources to undertake cooperative scientific benefits that might result from Diversaâ??s research research activities equitably and efficiently . involving microorganisms collected at Yellowstoneâ??s hot For ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ purposes , the statute defines the term springs and other thermal features . The agreement grand - Federal â?? laboratory â?쳌 to mean â?? a facility or group of fathered in all of the biological material that Diversa sci - facilities owned , leased , or otherwise used by a Federal entists had collected at Yellowstone pursuant to permits agency , a substantial purpose of which is the performance before the benefit - sharing agreement was negotiated , as of research , development , or engineering by employees of well as derivatives and other results that might flow from the Federal Government â?쳌 . The statute also gives Federal Diversa research involving the material . agencies broad discretion relating to laboratory determina - In addition , the ï쳌¹ ï쳌® ï쳌° - Diversa ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ provided a package tions . The Senate Report that accompanied Congressional of revenue - sharing mechanisms that included a combined approval of the Federal Technology Transfer Act of ï?? ï?? ï?? ï?? up - front payment ( â?? creditable minimum annual royalty â?쳌 ) also explains that â?? this is a broad definition which is in - to the park of ï?? ï?? ï?? ï?? , ï?? ï?? ï?? ï쳌µ ï쳌³ ï쳌¤ over five years , additional tended to include the widest possible range of research 53 annual earned royalties based on a percentage of revenues institutions operated by the Federal Government â?쳌 . It generated by Diversa from Yellowstone - related research also states : results , and supplemental in - kind contributions of labo - To improve technology transfer , the Federal laboratories ratory equipment , scientific training , and other research need clear authority to do cooperative research , and they and conservation related activities . While the term of the need to be able to exercise that authority at the labora - ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ was for an initial five - year period , the agreement tory level . Agencies need to delegate to their labora - also provided that the benefit - sharing obligations survived tory directors the authority to manage and promote the results of their research . A requirement to go to agency termination ( very important since development of valuable headquarters for approval of industry collaborative discoveries can sometimes take many years to achieve ) . arrangements and patent licensing agreements can ef - The royalty rates and related payment information con - fectively prevent them . Lengthy headquarters approval tained in the ï쳌¹ ï쳌® ï쳌° - Diversa agreement relate specifically delays can cause businesses to lose interest in developing to Diversaâ??s commercial and pricing interests in products 54 new technologies . that may be derived from research results involving bio - The Department of the Interiorâ??s ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ policy was logical samples acquired from the park . The rates were ï?? ï?? ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ the result of negotiations involving confidential business acquired from the park . proprietary information obtained from Diversa , which The agreement did not expand the scope of authorized advised Yellowstone that disclosure of this information research specimen sampling activities atYellowstone . The 59 would harm the companyâ??s commercial interests inasmuch fundamental rules of access were not changed ; but the as it relates to cost issues that are relevant to Diversaâ??s agreement did provide for the sharing of benefits result - pricing policies . Diversa also advised Yellowstone that it ing from Diversaâ??s Yellowstone - related research activi - 60 does not release this information to the public because ties â?? and that was something new . of its pricing sensitivity . In light of this , the specific roy - The ï쳌¹ ï쳌® ï쳌° - Diversa ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ was challenged in federal alty rates were treated as confidential information under court in early ï?? ï?? ï?? ï?? . After review , the federal judiciary 57 Exemption ï?? of the Federal Freedom of InformationAct . upheld the ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ as consistent with the National Park Yellowstone did disclose , however , that the rates ranged Service Organic Act , the Yellowstone National Park 58 from between ï?? . ï?? and ï?? ï?? % of net revenues earned by OrganicAct , the Federal Technology TransferAct of ï?? ï?? ï?? ï?? , 61 Diversa on research results involving biological samples ï쳌® ï쳌° ï쳌³ regulations , and the â?? public trust doctrine â?쳌 . The court Box 1 . Cooperative Research and Development Agreement for a Project between Yellowstone National Park and Diversa Corporation ( Text presented as it was actually executed by the parties , the referenced appendices are not provided here . ) GENERAL PROVISIONS activities , and to pursue the discovery and development of This Cooperative Research and Development Agreement new bioactive materials that advance humanitarian goals and ( â?? ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ â?쳌 ) is entered into by and between Diversa Corporation the public welfare ; and ( â?? Collaborator â?쳌 ) , a corporation organized under the laws of ï쳌· ï쳌¨ ï쳌¥ ï쳌² ï쳌¥ ï쳌¡ ï쳌³ , Collaborator agrees that efforts by the ï쳌® ï쳌° ï쳌³ to Delaware and maintaining its principal corporate office protect the physical , hydrological , and ecological integrity of headquarters at ï?? ï?? ï?? ï?? ï?? Sorrento Valley Road , San Diego , ï쳌¹ ï쳌® ï쳌° â?? s thermal features , hot springs , and geysers , all of which California , ï?? ï?? ï?? ï?? ï?? , andYellowstone National Park ( ï쳌¹ ï쳌® ï쳌° ) of the contain globally unique microbial ecosystems , contributes National Park Service ( ï쳌® ï쳌° ï쳌³ ) , ï쳌µ ï쳌³ Department of the Interior . significantly to the research and development of useful ï쳌· ï쳌¨ ï쳌¥ ï쳌² ï쳌¥ ï쳌¡ ï쳌³ , ï쳌® ï쳌° ï쳌³ and Collaborator wish to engage in co - discoveries ; and operative activities to promote the conservation , protection , ï쳌· ï쳌¨ ï쳌¥ ï쳌² ï쳌¥ ï쳌¡ ï쳌³ , Collaborator further agrees that the aforesaid perpetuation , and management of biological diversity while protection of ï쳌¹ ï쳌® ï쳌° â?? s microbial resources requires sophisticated undertaking scientific research and investigating potentially interdisciplinary scientific work by ï쳌¹ ï쳌® ï쳌° staff and dedicated useful applications and processes that might be derived effort by ï쳌® ï쳌° ï쳌³ management , including working with neighbor - from research on certain biological materials existing in ing jurisdictions to ensure protection of the thermal features , ï쳌¹ ï쳌® ï쳌° ; and hot springs , and geysers ; and ï쳌· ï쳌¨ ï쳌¥ ï쳌² ï쳌¥ ï쳌¡ ï쳌³ , it is the intention of ï쳌® ï쳌° ï쳌³ to improve the con - ï쳌· ï쳌¨ ï쳌¥ ï쳌² ï쳌¥ ï쳌¡ ï쳌³ , ï쳌® ï쳌° ï쳌³ agrees that Collaborator has incurred and servation , management , protection , and perpetuation of park will continue to incur significant time , effort and expense in resources to the fullest extent possible consistent with their research and development and management of technology mandate to conserve the scenery , natural and historic ob - which will facilitate the research and development of use - jects , and wildlife , so as to leave them unimpaired for future ful discoveries from samples received from ï쳌¹ ï쳌® ï쳌° under this generations ; and ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ ; and ï쳌· ï쳌¨ ï쳌¥ ï쳌² ï쳌¥ ï쳌¡ ï쳌³ , it is the intention of ï쳌® ï쳌° ï쳌³ to cooperate in activi - ï쳌· ï쳌¨ ï쳌¥ ï쳌² ï쳌¥ ï쳌¡ ï쳌³ , ï쳌® ï쳌° ï쳌³ further agrees that the aforementioned ties that benefit scientific research within the areas adminis - research , development and management of technology has tered by them ; and required highly sophisticated , interdisciplinary work by ï쳌· ï쳌¨ ï쳌¥ ï쳌² ï쳌¥ ï쳌¡ ï쳌³ , ï쳌® ï쳌° ï쳌³ coordinates research activities , facilitates Collaboratorâ??s staff and management ; and the exchange of research - related information pertaining to the ï쳌· ï쳌¨ ï쳌¥ ï쳌² ï쳌¥ ï쳌¡ ï쳌³ , ï쳌® ï쳌° ï쳌³ further agrees and recognizes that natural resources found at ï쳌¹ ï쳌® ï쳌° , and promotes the opportunity Collaborator has a capability to discover useful products to conduct symposiums and develop publications about such from samples obtained from ï쳌¹ ï쳌® ï쳌° under this ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ utilizing research , which will be supported by the cooperative research Collaboratorâ??s proprietary technologies ; and activities authorized by this ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ ; and ï쳌· ï쳌¨ ï쳌¥ ï쳌² ï쳌¥ ï쳌¡ ï쳌³ , it is recognized that ï쳌¹ ï쳌® ï쳌° derives national dignity ï쳌· ï쳌¨ ï쳌¥ ï쳌² ï쳌¥ ï쳌¡ ï쳌³ , Collaborator is dedicated to the discovery and and recognition of superb environmental quality through its development of new bioactive materials for chemical syn - inclusion in the National Park System preserved and man - thesis , diagnostics , industrial and pharmaceutical uses , and aged for the benefit and inspiration of all the people of the agrees to cooperate with ï쳌® ï쳌° ï쳌³ to undertake beneficial scientific United States , and the superlative natural microbial resources research relating to certain biological materials existing in found in ï쳌¹ ï쳌® ï쳌° may be considered invaluable and priceless in ï쳌¹ ï쳌® ï쳌° , to share information and data relating to such research , nature ; and and to protect and monitor those materials and other resources ï쳌· ï쳌¨ ï쳌¥ ï쳌² ï쳌¥ ï쳌¡ ï쳌³ , the aforesaid protection occurs at considerable in ï쳌¹ ï쳌® ï쳌° ; and annual expense to the taxpayers of the United States . ï쳌· ï쳌¨ ï쳌¥ ï쳌² ï쳌¥ ï쳌¡ ï쳌³ , Collaborator agrees to apply the highest profes - Now , therefore , in consideration of the promises contained sional and scientific standards in its research and development in this agreement , the parties agree as follows : ï?? ï?? ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : USA also noted that Section ï?? ï?? ï?? of the National Parks Omnibus pending a showing of ï쳌® ï쳌¥ ï쳌° ï쳌¡ compliance . Thereafter , the Management Act of ï?? ï?? ï?? ï?? , which was enacted after initial court dismissed the plaintiffs â?? case challenging the ï쳌¹ ï쳌® ï쳌° - 63 negotiation of the ï쳌¹ ï쳌® ï쳌° - Diversa ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ , specifically au - Diversa ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ with prejudice . thorizes â?? negotiations with the research community and Plaintiffs appealed the courtâ??s decision upholding private industry for equitable , efficient benefits - sharing the ï쳌¹ ï쳌® ï쳌° - Diversa ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ under the National Park Service arrangements â?쳌 involving ï쳌® ï쳌° ï쳌³ units . Organic Act , the Yellowstone National Park Organic Act , Specifically , the courtâ??s analysis concluded that ï쳌® ï쳌° ï쳌³ the Federal Technology Transfer Act of ï?? ï?? ï?? ï?? , and ï쳌® ï쳌° ï쳌³ units ( such as Yellowstone ) that satisfy the definition of a regulations in the ï쳌µ ï쳌³ ï쳌¡ Court of Appeals for the District Federal â?? laboratory â?쳌 as provided in the ï쳌¦ ï쳌´ ï쳌´ ï쳌¡ are eligible of Columbia Circuit . Following preparation and filing of to negotiate ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ s with qualified researchers . However , ï쳌® ï쳌° ï쳌³ â?? brief in support of the district courtâ??s ruling upholding the court also ruled that ï쳌® ï쳌° ï쳌³ is required to complete an the ï쳌¹ ï쳌® ï쳌° - Diversa ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ , the plaintiffs asked the Federal analysis under ï쳌® ï쳌¥ ï쳌° ï쳌¡ before the ï쳌¹ ï쳌® ï쳌° - Diversa ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ can appeals court to dismiss their appeal . The appeal was 62 be implemented . Therefore , the ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ was suspended dismissed on ï?? ï?? December ï?? ï?? ï?? ï?? . Box 1 . Continued ARTICLE 1 . LEGAL AUTHORITY the conception or first actual reduction to practice of such ï?? . ï?? . This agreement is authorized under the National Park Invention . Service OrganicAct , as amended , ï?? ï?? ï쳌µ ï쳌³ ï쳌£ § § ï?? - ï?? ; and the Federal ï?? . ï?? ï?? . The term â?? Native Enzymes â?쳌 means any catalytic pro - Technology Transfer Act , as amended , ï?? ï?? ï쳌µ ï쳌³ ï쳌£ § § ï?? ï?? ï?? ï?? - ï?? ï?? ï?? ï?? . teins , not in a recombinant form , produced by living cells ï?? . ï?? . Payments accepted and retained by ï쳌¹ ï쳌® ï쳌° from Collaborator that mediate or promote chemical processes in living cells are authorized under ï?? ï?? ï쳌µ ï쳌³ ï쳌£ § ï?? ï?? ï?? ï?? a ( b ) ( ï?? ) . that originated from ï쳌¹ ï쳌® ï쳌° . ï?? . ï?? ï?? . The term â?? Natural Products â?쳌 means any naturally oc - ARTICLE 2 . DEFINITIONS curring Research Specimen located in or taken from ï쳌¹ ï쳌® ï쳌° . ï?? . ï?? . The term â?? Background Intellectual Property â?쳌 ( ï쳌¢ ï쳌© ï쳌° ) ï?? . ï?? ï?? . The term â?? Net Sales â?쳌 means the total gross receipts refers to a patent or patent application covering an Invention for sales by Collaborator , its licensees or sublicensees of or discovery of either party , or a copyrighted work , a mask Product ( s ) and copyrighted works created using the results work , trade secret , or trademark developed with separate of research under this ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ , and from otherwise making funds outside of the ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ by one of the parties or with oth - Product ( s ) available to others without sale , whether invoiced ers . ï쳌¢ ï쳌© ï쳌° is not considered as a Subject Invention . or not , less returns and allowances actually granted , packing ï?? . ï?? . The term â?? Collaboratorâ??sAssigned Employees â?쳌 means costs , insurance costs , freight out , taxes and excise duties those employees of the Collaborator who are present at ï쳌¹ ï쳌® ï쳌° imposed on the transaction ( if separately invoiced ) , and the for a continuous period of more than two weeks . wholesaler and cash discounts in amounts customary in the ï?? . ï?? . The term â?? Cooperative Research and Development trade . No deductions shall be made for commissions paid to Agreement â?쳌 ( ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ ) means this document and all attach - individuals , whether they be with independent sales agen - ments describing research activities jointly undertaken by cies or regularly employed by Collaborator , its licensee or ï쳌® ï쳌° ï쳌³ and the Collaborator . sublicensees , or for the cost of collections . ï?? . ï?? . The term â?? created â?쳌 in relation to any copyrightable ï?? . ï?? ï?? . The term â?? Pharmaceutical Products â?쳌 means â?? drug â?쳌 software work means when the work is fixed in any tangible as defined by the Federal Food , Drug and Cosmetic Act at medium of expression for the first time , as provided for at ï?? ï?? ï쳌µ ï쳌³ ï쳌£ § ï?? ï?? ï?? ( g ) . ï?? ï?? ï쳌µ ï쳌³ ï쳌£ § ï?? ï?? ï?? . ï?? . ï?? ï?? . The term â?? Product â?쳌 means any Subject Invention and ï?? . ï?? . The term â?? Generated Information â?쳌 means information any commercially valuable or otherwise useful material , produced in the performance of the ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ . compound or useful combination of compounds , protein , ï?? . ï?? . The term â?? Industrial Products â?쳌 means any product or metabolite [ which is encoded by a nucleotide sequence designed , developed or used in any process associated with recovered , obtained , derived , resulting , or otherwise isolated manufacturing , agriculture , chemical products , commerce from scientific research conducted ] on a Research Specimen or industry . acquired from ï쳌¹ ï쳌® ï쳌° , or any derivative or analog of such mate - ï?? . ï?? . The term â?? Intellectual Property â?쳌 means patents , rial , compound , protein , metabolite or other isolate , or any trademarks , copyrights , trade secrets , mask works , and discovery which is or may be patentable or otherwise pro - other forms of comparable property protectable by federal , tected under Title ï?? ï?? of the United States Code , or any novel state , or foreign laws . variety of plant which is or may be protectable under the Plant Variety Protection Act ( ï?? ï쳌µ ï쳌³ ï쳌£ § ï?? ï?? ï?? ï?? et seq . ) and developed ï?? . ï?? . The term â?? Invention â?쳌 means any invention or discovery from Research Specimens acquired from ï쳌¹ ï쳌® ï쳌° . that is or may be patentable or otherwise protected under Title ï?? ï?? of the United States Code , or any novel variety of ï?? . ï?? ï?? . The term â?? Proprietary Information â?쳌 means trade plant which is or may be protectable under the Plant Variety secrets or commercial or financial information that is Protection Act ( ï?? ï쳌µ ï쳌³ ï쳌£ § ï?? ï?? ï?? ï?? et seq . ) . privileged or confidential within the meaning of ï?? ï쳌µ ï쳌³ ï쳌£ § ï?? . ï?? . The term â?? made â?쳌 in relation to any Invention means ï?? ï?? ï?? ( b ) ( ï?? ) , obtained in the conduct of research or as a result ï?? ï?? ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ In early ï?? ï?? ï?? ï?? while the ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ was suspended , completion of the environmental impact study conducted Diversa publicly announced that it had developed a new in compliance with the courtâ??s decision . product from research specimens originally acquired from As a result of the cooperative research activities initi - Yellowstone . The product development is significant be - ated under the ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ , Diversa also contributed important cause it represents one of the worldâ??s only examples where genetic identification services toYellowstone in connection a company has brought a new product to market after it with the parkâ??s management of its recently reintroduced negotiated a benefit - sharing agreement with the provider wolf population . This research work was considered by of the original biological resources . Diversa has pledged Yellowstone to be one of the most valuable â?? in - kind â?쳌 ben - payment of all royalties due provided that the agree - efits derived by the park from the ï쳌¹ ï쳌® ï쳌° - Diversa benefit - ment suspension is cleared . Also , it should be noted that sharing ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ , even though it was not directly related to Yellowstone has not spent any of the initial ï?? ï?? ï?? ï?? , ï?? ï?? ï?? ï쳌µ ï쳌³ ï쳌¤ . Diversaâ??s research on Yellowstone hot spring organisms . The funds are being held in escrow and will be kept until The genetic pedigree information developed and donated Box 1 . Continued of activities under the terms of this ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ from a non - Federal information for public disclosure . party participating in this ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ , as provided at ï?? ï?? ï쳌µ ï쳌³ ï쳌£ § ï?? . ï?? . Payment Reports . Concurrently with each payment , or ï?? ï?? ï?? ï?? a ( b ) ( A ) . at such other time as payments are due , Collaborator shall submit a written report to ï쳌® ï쳌° ï쳌³ setting forth ( a ) the period ï?? . ï?? ï?? . The term â?? Protected ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ Information â?쳌 means for which the payment is made , ( b ) the amount , description , Generated Information that is marked as being Protected and aggregate Net Sales of the Product ( s ) sold or otherwise ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ Information by a party to this agreement and that disposed of , upon which a payment is payable for such com - would have been Proprietary Information had it been obtained pleted calendar year as provided under this ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ , ( c ) the from a non - Federal entity . total gross income realized by Collaborator from the sale , ï?? . ï?? ï?? . The term â?? Research Reagent Products or Diagnostics â?쳌 licensing , or otherwise making Product ( s ) available to itself means any product manufactured specifically and primarily and others without sale , during such completed calendar year , for use in research tests , or applications in research labora - and ( d ) the resulting calculation pursuant to this section ï?? of tories or development centers . This term does not include the amount of all payments due thereon . If no payments are items used for evaluation by a customer to make a prospec - due ï쳌® ï쳌° ï쳌³ for any report period , the report shall so state . tive use decision . ï?? . ï?? . Copyright Reports . Concurrently with each payment of ï?? . ï?? ï?? . The term â?? Research Specimens â?쳌 means those items royalties on copyrighted materials as required by Appendix Collaborator has authority to collect under the collection B , or at such other time as payments are due , the Collaborator permit or permits issued by ï쳌¹ ï쳌® ï쳌° to the Collaborator . shall submit a written report setting forth the period for which ï?? . ï?? ï?? . The term â?? Subject Data â?쳌 means all recorded informa - the payment is made , the amount and a description of the tion first produced in the performance of this ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ . copyrighted works upon which a royalty is payable , the net ï?? . ï?? ï?? . The term â?? Subject Invention â?쳌 means any Invention of sales or other income received therefrom by the Collaborator , the Collaborator or ï쳌® ï쳌° ï쳌³ conceived or first actually reduced to and the amount of royalties due thereon . If no royalties are practice in the performance of work under this ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ . due ï쳌® ï쳌° ï쳌³ for any report period , the report shall so state . ARTICLE 3 . STATEMENT OF WORK ï?? . ï?? . Records . Collaborator agrees to keep records showing the ï?? . ï?? . Cooperative research performed under this ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ shall sales or other dispositions of all works upon which payments be performed in accordance with the attached Statement of are due under the provisions of this ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ in sufficient detail Work , which is incorporated by reference into this agreement . to enable ï쳌® ï쳌° ï쳌³ to determine the payments payable hereunder The parties may modify the initial Statement of Work by by Collaborator . Collaborator agrees to retain the records for a mutual agreement and incorporate it herein by amendment minimum period of five ( ï?? ) years from the date a subject pay - as set out in paragraph ï?? ï?? . ï?? . ment is due . Collaborator further agrees to permit an auditor selected by ï쳌® ï쳌° ï쳌³ to examine its books and records from time - ARTICLE 4 . REPORTS to - time during its ordinary business hours and not more often ï?? . ï?? . Research Reports . As required by the collection permits than once a year to the extent necessary to verify the reports that ï쳌¹ ï쳌® ï쳌° issued to Collaborator , Collaborator will prepare and provided for in this Article . ï쳌® ï쳌° ï쳌³ will bear the initial expense provide to ï쳌® ï쳌° ï쳌³ a written report concerning the research activi - of the audit . If the audit indicates that ï쳌® ï쳌° ï쳌³ was underpaid ties authorized by the collection permits , which shall include , royalties by at least ten percent ( ï?? ï?? % ) for any calendar year , but not be limited to , such information as the Superintendent or five - thousand dollars ( ï쳌µ ï쳌³ ï?? ï?? , ï?? ï?? ï?? . ï?? ï?? ) , whichever is greater , of ï쳌¹ ï쳌® ï쳌° may require , including , but not limited to , all informa - collaborator will reimburse ï쳌® ï쳌° ï쳌³ for the expense of the audit , tion required under this ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ . ï쳌® ï쳌° ï쳌³ shall have the right to together with an amount equal to the additional royalties to use such reports for any Governmental purpose including but which ï쳌® ï쳌° ï쳌³ is entitled . not limited to the conservation of natural resources at ï쳌¹ ï쳌® ï쳌° . In the event Collaborator asserts that particular information ARTICLE 5 . FINANCIAL OBLIGATION delivered to ï쳌® ï쳌° ï쳌³ is proprietary , Collaborator agrees to provide ï?? . ï?? . Collaborator hereby agrees to make the payments to ï쳌® ï쳌° ï쳌³ a nonconfidential nonproprietary summary of such and other contributions set forth in Appendix B . Unless ï?? ï?? ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : USA to the park by Diversa enables park biologists to monitor negotiated arrangements with the research community ) , and assess the genetic health of Yellowstoneâ??s growing Yellowstone can strengthen its protection of these re - wolf population , as well as to precisely identify any wolves sources by directing scientists to less studied pools known that are found killed . The information also will enable park to hold desired organisms . Many firms also have told the biologists to detect when wolves from other areas , such as park that their willingness to negotiate benefit - sharing ar - Idaho or northwest Montana , migrate into Yellowstone . rangements that are favorable toYellowstone is contingent The park has observed that corporations , universities , on the contributions being used for resource conservation and others increasingly recognize the need to satisfy public purposes , a very important underlying incentive . benefit - sharing expectations . For example , with improved Yellowstone also has observed that the likelihood of data relating to microbial distributions throughout various generating economic value from research results cannot thermal systems at the park ( which will be an ongoing be determined from a look at institutional affiliations only . scientific â?? benefit â?쳌 that Yellowstone may obtain through This is because many academic researchers have close Box 1 . Continued otherwise specified , Collaborator agrees to make all pay - ARTICLE 7 . PATENT RIGHTS ments to ï쳌® ï쳌° ï쳌³ in ï쳌µ ï쳌³ Dollars , net of all non - ï쳌µ ï쳌³ taxes ( if any ) , ï?? . ï?? . Reporting . The parties agree to disclose to each other by check or bank draft drawn on a United States bank and every Subject Invention , which may be patentable or oth - made payable to â?? Yellowstone National Park . â?쳌 The parties erwise protectable , within sixty ( ï?? ï?? ) days of the time that estimate Collaboratorâ??s total contribution at a minimum of an inventing party reports such Invention to the person ( s ) ï쳌µ ï쳌³ ï?? ï?? ï?? ï?? , ï?? ï?? ï?? , in funds ( parties acknowledge that the payment responsible for patent matters in the inventing organization . for ï?? ï?? ï?? ï?? has been made ) plus royalties , and in - kind services These disclosures should be in sufficient enough detail to en - and resources valued at ï쳌µ ï쳌³ ï?? ï?? ï?? ï?? , ï?? ï?? ï?? . The method and schedul - able a reviewer to make and use the invention under ï?? ï?? ï쳌µ ï쳌³ ï쳌£ ing of payment for current and subsequent years is included § ï?? ï?? ï?? . The disclosure shall also identify any statutory bars , in Appendix B . i.e . , printed publications describing the Subject Invention ï?? . ï?? . The contribution of ï쳌¹ ï쳌® ï쳌° shall be in the form of resource or public use or sale of the Subject Invention in the United protection , labor , expertise , equipment , facilities , information , States . The parties further agree to disclose to each other any computer software , and other forms of laboratory support , subsequent statutory bar that occurs for a Subject Invention subject to available funding . disclosed but for which a patent application has not been filed . All such disclosures shall be marked as â?? CONFIDENTIAL â?쳌 ï?? . ï?? . The Collaborator will make all payments to ï쳌¹ ï쳌® ï쳌° in ac - under ï?? ï?? ï쳌µ ï쳌³ ï쳌£ § ï?? ï?? ï?? . cordance with provisions ofAppendix B.All payments by the Collaborator shall be mailed to the following address : ï?? . ï?? . Collaborator Employee Inventions . The Collaborator may Yellowstone National Park retain title to any Subject Invention made solely by its employ - Office of the Superintendent ees . The Collaborator agrees to file patent applications on such Attention : Yellowstone Center for Resources Subject Invention at its own expense and in a timely fashion . ï쳌° ï쳌¯ Box ï?? ï?? ï?? The Collaborator agrees to grant to the ï쳌µ ï쳌³ Government a Yellowstone National Park , Wyoming ï?? ï?? ï?? ï?? ï?? nonexclusive , nontransferable , irrevocable , paid - up license ï?? . ï?? . Overpayments by the Collaborator shall be offset against in the patents covering Subject Inventions developed by payments due the following year . Collaboratorâ??s employees to practice the invention or have the invention practiced , throughout the world by or on behalf ï?? . ï?? . If the audit described in paragraph ï?? . ï?? , above , indicates of the ï쳌µ ï쳌³ Government . Such nonexclusive license shall be that payments are overdue to ï쳌® ï쳌° ï쳌³ , an interest charge will be assessed on the overdue amounts for each ï?? ï?? - day period , or evidenced by a confirmatory license agreement prepared by portion thereof , that payment is delayed beyond the periods the Collaborator in a form satisfactory to ï쳌® ï쳌° ï쳌³ . described in Appendix B . The percent of interest charged ï?? . ï?? . NPS Employee Inventions . ï쳌® ï쳌° ï쳌³ , on behalf of the ï쳌µ ï쳌³ will be based on the current value of funds to the United Government , shall have the initial option to retain title to States Treasury as published quarterly in the Treasury Fiscal each Subject Invention made by its employees under this Requirements Manual . ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ . If a Subject Invention is made jointly by personnel of both parties under this ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ , it and all patent applica - ARTICLE 6 . RECOGNITION OF CONTRIBUTION tions and patents issued thereon shall be jointly owned by the FROM YELLOWSTONE NATIONAL PARK parties , subject to the obligations contained in Articles ï?? . ï?? ï?? . ï?? . Collaborator recognizes that the priceless nature of the and ï?? . ï?? herein . ï쳌® ï쳌° ï쳌³ may release the rights provided for by research specimens at ï쳌¹ ï쳌® ï쳌° , and the efforts and expertise that this paragraph to employee inventors or to the Collaborator ï쳌® ï쳌° ï쳌³ has invested in the preservation , conservation , and protec - subject to a license in ï쳌® ï쳌° ï쳌³ . tion of the research specimens will contribute significantly ï?? . ï?? . Filing of Patent Applications . The party having the right to the discovery of Subject Inventions and development of to retain title and file patent applications on a specific Subject products from the ï쳌¹ ï쳌® ï쳌° research specimens , and , as a result , Invention may elect not to file patent applications thereon agrees that the ï쳌µ ï쳌³ Government has a compensable interest provided that it so advises the other party within ninety ( ï?? ï?? ) in any Subject Inventions and products developed from ï쳌¹ ï쳌® ï쳌° research specimens . days from the date it reports the Subject Invention to the ï?? ï?? ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ research ties with biotech and other industrial firms , to who is conducting the research . Here , too , a negotiated while corporate researchers are not necessarily engaged benefit - sharing agreement can satisfy a parkâ??s needs , the in product - specific research . What seems increasingly publicâ??s expectations , and the incentives required to en - clear , however , is that â?? value â?쳌 can attach to research re - hance scientific research in national parks consistent with sults at any stage in the research process without regard the National Parks Omnibus Management Act of ï?? ï?? ï?? ï?? . Conclusion Although the ï쳌µ ï쳌³ ï쳌¡ has not ratified the ï쳌£ ï쳌¢ ï쳌¤ , the access and tions â?쳌 , and the law continues to be refined as circumstances benefit - sharing initiative pioneered by ï쳌® ï쳌° ï쳌³ is consistent require . with the ï쳌£ ï쳌¢ ï쳌¤ â?? s main aims . The ï쳌µ ï쳌³ ï쳌¡ Congress enacted The ï쳌® ï쳌° ï쳌³ permit system , which is the pragmatic mecha - national legislation governing access to national parks a nism used to regulate individual access to national park century ago with the aim of conserving and managing the resources for research purposes , implements the concept resources to leave them unimpaired for â?? future genera - of ï쳌° ï쳌© ï쳌£ through the detailed permit application and approval Box 1 . Continued other party . Thereafter , the other party may elect to file patent Collaborator from ï쳌® ï쳌° ï쳌³ under the terms and conditions of this ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ . Collaborator may exercise such right applications on the Subject Invention and the party initially without obtaining additional authorization from ï쳌® ï쳌° ï쳌³ , but reporting such Subject Invention agrees to assign its right , Collaborator expressly agrees that in so licensing or sub - title , and interest in such Subject Invention to the other party licensing , it will specifically reserve to ï쳌® ï쳌° ï쳌³ all rights and and cooperate with such party in the preparation and filing privileges provided in this agreement for ï쳌® ï쳌° ï쳌³ , including of patent applications thereon . The assignment of the entire the provisions of Appendix B . In the event of a license or right , title , and interest to the party pursuant to this paragraph sublicense , Collaborator will notify ï쳌® ï쳌° ï쳌³ of each license and shall be subject to the retention by the party assigning title sublicense to enable ï쳌® ï쳌° ï쳌³ to call for the reports provided for of a nonexclusive , irrevocable , paid - up license to practice , or in this agreement . have practiced , the Subject Invention throughout the world . ï?? . ï?? . Enforcement of jointly owned Patents . Collaborator must In the event that none of the parties to this ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ elect to advise ï쳌® ï쳌° ï쳌³ of any events that cause Collaborator to suspect file a patent application on a Subject Invention , either or that a third party is or may be infringing on jointly owned both ( if a joint invention ) may , at their sole discretion and patents resulting from research conducted under this ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ subject to reasonable conditions , release the right to file to ( hereafter ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ patents ) . Collaborator must institute and dil - the inventor ( s ) with a license in each party of the same scope igently prosecute proper legal proceedings at Collaboratorâ??s as set forth in the immediate preceding sentence . own expense in the event of infringement of ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ patents . ï?? . ï?? . Patent Expenses . All of the expenses attendant to the fil - Should Collaborator fail to institute such proceedings within ing of patent applications as specified in paragraph ï?? . ï?? above , ï?? ï?? days from receipt of written request from ï쳌® ï쳌° ï쳌³ to institute shall be borne by the party filing the patent application . Any such proceedings , ï쳌® ï쳌° ï쳌³ may take the following actions : post - filing and post - patent fees also shall be borne by the same â?¢ Institute a suit in its own name as subrogee of Collaboratorâ??s party . Each party shall provide the other party with copies rights to enforce the patent ; or of the patent applications it files on any Subject Invention at â?¢ Institute a suit against Collaborator for damages result - the time the application is filed at the ï쳌µ ï쳌³ Patent & Trademark ing from Collaboratorâ??s failure to terminate or abate the Office or patent office of another country . Each party also infringement . will provide the other party with the power to inspect and In the event of institution of a suit for infringement by ï쳌® ï쳌° ï쳌³ make copies of all documents retained in the official patent pursuant hereto , it is understood that Collaborator may application files by the applicable patent office . participate and be represented by its own counsel ; however , ï?? . ï?? . License Provisions . any recovery damages shall be equitably apportioned , less ï?? . ï?? . ï?? . If requested , ï쳌® ï쳌° ï쳌³ agrees to provide an exclusive the ï쳌µ ï쳌³ government litigation costs . Either party may make license for a pre - negotiated field of use in any Subject reasonable settlements with respect to any infringements . Invention made in whole or in part by a ï쳌® ï쳌° ï쳌³ employee Collaborator agrees to join in any legal proceedings brought for reasonable compensation . The Collaboratorâ??s right by ï쳌® ï쳌° ï쳌³ if joinder is required by law . to negotiate a license ( s ) begins at the time that a Subject ï?? . ï?? . Commercialization . The Collaborator agrees to inform Invention disclosure is filed and ceases six months after ï쳌® ï쳌° ï쳌³ when any Subject Invention is commercialized by provid - the termination of this ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ for all Subject Inventions . ing written notice to ï쳌® ï쳌° ï쳌³ . The grant of an exclusive license to Collaborator shall be subject to a nonexclusive , nontransferable , irrevocable , ARTICLE 8 . COPYRIGHTS paid - up license from Collaborator to ï쳌® ï쳌° ï쳌³ to practice the ï?? . ï?? . The Collaborator shall have the option to own the copy - invention or have the invention practiced throughout the right in all software ( including modifications and enhance - world by or on behalf of the ï쳌µ ï쳌³ Government . ment thereto ) , documentation , or other works created in whole ï?? . ï?? . ï?? . Collaborator , at any time , may license or sublicense or in part by the Collaborator under this ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ , which is in whole or in part , any rights and interests granted to subject to being copyrighted under Title ï?? ï?? , United States ï?? ï?? ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : USA process now instituted throughout the ï쳌® ï쳌° ï쳌³ . The emphasis for conserving biological diversity , Yellowstone aimed on â?? cooperation â?쳌 and â?? mutually agreed [ that is , negotiated ] to strengthen research in ways that also might contribute terms â?쳌 found throughout Article ï?? ï?? of the ï쳌£ ï쳌¢ ï쳌¤ is further significantly to the parkâ??s sustainable resource conserva - manifested in the ï쳌® ï쳌° ï쳌³ approach towards benefit sharing . tion efforts . However , whereas the ï쳌£ ï쳌¢ ï쳌¤ refers to â?? sharing in a fair and Through the development of its pilot bioprospecting equitable way the results of research , â?쳌 the National Parks project , Yellowstone has helped to create for national parks Omnibus Management Act of ï?? ï?? ï?? ï?? adds the qualifier â?? ef - the opportunity to evaluate how negotiated benefit - sharing ficient â?쳌 in reference to benefit - sharing negotiations . arrangements might strengthen their resource conserva - It is clear that the public and Congress expect firms tion mission while also stimulating research incentives in that profit from research involving national park resources ways that could return scientific and economic dividends to share the benefits resulting from their research with to the parks . Without discouraging research opportunities the park units like Yellowstone for resource conservation for the broad - based scientific community , theYellowstone purposes . By linking the scientific and economic incen - experience suggests that parks can be positioned to share tives associated with research activities and new incentives in the full range of benefits of research results for resource Box 1 . Continued Code . The Collaborator shall mark any such works with a is required pursuant to a request under the Freedom of Information Act , as amended ( ï?? ï쳌µ ï쳌³ ï쳌£ § ï?? ï?? ï?? et seq . ) ; pro - copyright notice showing the Collaborator as the author or vided , however , that such data shall not be released to the co - author and shall in its reasonable discretion determine public if a patent application is to be filed ( ï?? ï?? ï쳌µ ï쳌³ ï쳌£ § ï?? ï?? ï?? ) whether to file applications for registration of copyright . until the party having the right to file the patent application ï?? . ï?? . The Collaborator agrees to grant to the ï쳌µ ï쳌³ Government , has had a reasonable time to file . solely for its purposes , a nonexclusive , irrevocable , paid - up , ï?? ï?? . ï?? . ï?? . Proprietary Information . The Collaborator shall worldwide license ( hereinafter referred to as Government place a proprietary notice on all information it delivers Purpose License ) in all copyrighted software or other copy - to ï쳌® ï쳌° ï쳌³ under this ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ that the Collaborator asserts is righted works developed under this ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ . The Government proprietary . ï쳌® ï쳌° ï쳌³ agrees that it will use any information Purpose License ( â?? ï쳌§ ï쳌° ï쳌¬ â?쳌 ) conveys to the ï쳌µ ï쳌³ Government the designated as proprietary that the Collaborator furnishes right to use , duplicate , or disclose the copyrighted software to ï쳌® ï쳌° ï쳌³ under this ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ , only for the purpose of carrying or other works in whole or in part , and in any manner , for out this ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ . ï쳌® ï쳌° ï쳌³ agrees not to disclose , copy , reproduce , Government purposes only , and to have or permit others to or otherwise make available in any form whatsoever in - do so for Government purposes only . Government purposes formation designated as proprietary to any other person , include competitive procurement , but do not include the right firm , corporation , partnership , association , or other entity to have or permit others to use the copyrighted software or without the consent of the Collaborator , except as such in - other works for commercial purposes . formation may be subject to disclosure under the Freedom ï?? . ï?? . The Collaborator will clearly mark all copyrighted soft - of Information Act , as amended ( ï?? ï쳌µ ï쳌³ ï쳌£ § ï?? ï?? ï?? , et seq . ) . ï쳌® ï쳌° ï쳌³ ware or other works subject to the ï쳌§ ï쳌° ï쳌¬ with its name and the agrees to use its best efforts to protect information des - words â?? GOVERNMENT PURPOSE LICENSE . â?쳌 ignated as proprietary from unauthorized disclosure . The ï?? . ï?? . The Collaborator shall furnish to ï쳌® ï쳌° ï쳌³ , at no cost to ï쳌® ï쳌° ï쳌³ , Collaborator agrees that ï쳌® ï쳌° ï쳌³ is not liable for the disclosure at least one copy of each software , documentation or other of information designated as proprietary that , after notice work developed in whole or in part by the Collaborator under to and consultation with the Collaborator , ï쳌® ï쳌° ï쳌³ determines this ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ , subject to the terms and conditions of the ï쳌§ ï쳌° ï쳌¬ may not lawfully be withheld or that a court of competent granted to ï쳌® ï쳌° ï쳌³ under paragraph ï?? . ï?? . jurisdiction requires disclosure . ï?? ï?? . ï?? . ï?? . Background Intellectual Property . Both parties ARTICLE 9 . COPYRIGHT ROYALTIES agree to identify in advance and during the course of the ï?? . ï?? . Appendix B covers the obligations of the Collaborator ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ Background Intellectual Property ( ï쳌¢ ï쳌© ï쳌° ) that has to compensate ï쳌® ï쳌° ï쳌³ from royalties produced from the sale or value for the joint research but which was developed with use of copyrighted materials . As provided in Appendix B , separate funds outside the ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ . ï쳌¢ ï쳌© ï쳌° does not qualify as the Collaborator shall pay to ï쳌® ï쳌° ï쳌³ royalties over the life of a Subject Invention and is not subject to a government the copyright from the licensing , assignment , sale , lease , and use license . rental ( hereinafter â?? disposition â?쳌 ) of any copyrighted work ï?? ï?? . ï?? . Protected ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ Information . created under this ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ . ï?? ï?? . ï?? . ï?? . Each party may designate as Protected ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ ARTICLE 10 . DATA AND PUBLICATION Information , as defined in Article ï?? , any Generated ï?? ï?? . ï?? . Release Restrictions . ï쳌® ï쳌° ï쳌³ shall have the right to use all Information produced by its employees , and with the agree - Subject Data for any Governmental purpose , but shall not ment of the other party , mark any Generated Information release such Subject Data publicly except : produced by the other partyâ??s employees . All such desig - ( i ) ï쳌® ï쳌° ï쳌³ , when reporting on the results of sponsored research , nated Protected ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ Information shall be appropriately may publish Subject Data , subject to the provisions of para - marked . graph ï?? ï?? . ï?? below ; and ï?? ï?? . ï?? . ï?? . For a period of five ( ï?? ) years from the date the ( ii ) ï쳌® ï쳌° ï쳌³ may release such Subject Data where such release Protected ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ Information is produced , the parties agree ï?? ï?? ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ conservation purposes consistent with their mission , while of â?? negotiations with the research community and pri - also contributing to the ongoing advancement of science vate industry for equitable , efficient benefits - sharing ar - and related beneficial research as mandated by the National rangements â?쳌 as provided by the National Parks Omnibus 64 Parks Omnibus Management Act of ï?? ï?? ï?? ï?? . Management Act of ï?? ï?? ï?? ï?? . The study , which is expected In accordance with the Federal courtâ??s order of ï?? ï?? to be completed sometime in ï?? ï?? ï?? ï?? , is believed to be the 65 March ï?? ï?? ï?? ï?? , ï쳌® ï쳌° ï쳌³ is undertaking an environmental analy - first comprehensive analysis ever undertaken by any na - sis under ï쳌® ï쳌¥ ï쳌° ï쳌¡ of the potential environmental impacts of tion concerning the potential environmental impacts of various methods of implementing the provisions of law bioprospecting benefit - sharing agreements in protected that authorize benefit - sharing agreements while ensuring areas , and should provide a rich source of information for the integrity of ï쳌µ ï쳌³ ï쳌¡ national park resources . Specifically , others interested in the pragmatic implications of genetic the analysis concerns the potential environmental impacts resource management in the ï?? ï?? st century . Box 1 . Continued not to further disclose such Protected ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ Information on results to date of termination will be prepared by ï쳌¹ ï쳌® ï쳌° and except : the cost of the report will be deducted from any amounts due ( i ) as necessary to perform this ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ ; and to Collaborators from ï쳌¹ ï쳌® ï쳌° . ( ii ) as mutually agreed by the parties in writing in ad - ï?? ï?? . ï?? . In - kind payments received by ï쳌® ï쳌° ï쳌³ under paragraph ï?? of vance . Appendix B may be retained in support of the project . ï?? ï?? . ï?? . ï?? . The obligation of ï?? ï?? . ï?? . ï?? above shall end sooner ï?? ï?? . ï?? . A report on results to date of termination will be for any Protected ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ Information which shall become prepared by Collaborator and the cost of the report will be publicly known without fault of either party , shall come deducted from any amounts due to ï쳌® ï쳌° ï쳌³ . into a partyâ??s possession without breach by that party of ï?? ï?? . ï?? . Termination of this ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ by either party for any reason the obligations of ï?? ï?? . ï?? . ï?? above , or shall be independently shall not affect the rights and obligations of the parties accrued developed by a partyâ??s employees who did not have ac - prior to the effective date of termination of this ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ . No cess to the Protected ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ Information , or as required termination or expiration of this ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ , however effectuated , by the Freedom of Information Act , as amended ( ï?? ï쳌µ ï쳌³ ï쳌£ shall release the parties hereto from their rights , duties , and § ï?? ï?? ï?? , et seq . ) . obligations under Articles ï?? , ï?? , ï?? , ï?? ï?? , ï?? ï?? , and ï?? ï?? , and pay - ï?? ï?? . ï?? . Publication . ments due under Appendix B . ï?? ï?? . ï?? . ï?? . ï쳌® ï쳌° ï쳌³ may submit for publication the results of the ARTICLE 13 . DISPUTES research work associated with this project . Depending ï?? ï?? . ï?? . Settlement . Any dispute arising under this ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ which on the extent of contribution made , employees of the is not disposed of by agreement of the parties shall be submit - Collaborator may be cited as co - authors . In no event , ted jointly to the signatories of this ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ . A joint decision however , shall ï쳌® ï쳌° ï쳌³ use the name of Collaborator or any of of the signatories or their designees shall be the disposition its trademarks and tradenames in any publications without of such dispute . its prior written consent . ï?? ï?? . ï?? . ï?? . ï쳌® ï쳌° ï쳌³ and the Collaborator agree to confer and consult ï?? ï?? . ï?? . If the signatories are unable to jointly resolve a dispute at least thirty ( ï?? ï?? ) days prior to either partyâ??s submission within a reasonable period of time after submission of the for publication of Subject Data to assure that no Proprietary dispute for resolution , the matter shall be submitted to the Information or Protected ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ Information is released and Director of the ï쳌® ï쳌° ï쳌³ , or his designee , for resolution . that patent rights are not jeopardized . The party receiving ï?? ï?? . ï?? . Continuation of Work . Pending the resolution of any the document for review has thirty ( ï?? ï?? ) days from receipt dispute or claim pursuant to this Article , the parties agree that to object in writing detailing the objections to the proposed they will diligently pursue performance of all obligations in submissions . accordance with the direction of the ï쳌® ï쳌° ï쳌³ signatory . ARTICLE 11 . RIGHTS IN GENERATED ARTICLE 14 . LIABILITY INFORMATION ï?? ï?? . ï?? . Property . The ï쳌µ ï쳌³ Government shall not be responsible ï?? ï?? . ï?? . The parties understand that the Government shall have for damages to any property of the Collaborator provided to unlimited rights in all Generated Information or information ï쳌¹ ï쳌® ï쳌° pursuant to this ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ . provided to the parties under this ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ which is not marked ï?? ï?? . ï?? . Collaboratorâ??s Employees . as being copyrighted ( subject to Article ï?? ) or as Proprietary ï?? ï?? . ï?? . ï?? . During any temporary assignment at ï쳌¹ ï쳌® ï쳌° facili - Information ( subject to paragraph ï?? ï?? . ï?? . ï?? ) or as Protected ties that may result from this ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ , the Collaboratorâ??s ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ Information ( subject to paragraph ï?? ï?? . ï?? ) . Assigned Employees ( as defined in paragraph ï?? . ï?? of this ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ ) shall pursue their activities on the work schedule ARTICLE 12 . TERMINATION mutually agreed upon between them , the Collaborator , and ï?? ï?? . ï?? . The Collaborator and ï쳌® ï쳌° ï쳌³ each have the right to termi - ï쳌® ï쳌° ï쳌³ . The Collaboratorâ??sAssigned Employees must agree to nate this ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ upon thirty ( ï?? ï?? ) days notice in writing to the comply with Federal Government security and conduct reg - other party . In the event of termination by ï쳌¹ ï쳌® ï쳌° , ï쳌¹ ï쳌® ï쳌° shall repay ulations that apply to ï쳌¹ ï쳌® ï쳌° employees . The Collaboratorâ??s the collaborator any prorated portion of payments previously Assigned Employees shall conform to the requirements made to ï쳌¹ ï쳌® ï쳌° pursuant to Article ï?? . ï?? of the ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ in excess of actual costs incurred by ï쳌¹ ï쳌® ï쳌° in pursuing this project . A report of the Office of Government Ethics â?? Standards of Ethical ï?? ï?? ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : USA Acknowledgements The author wishes to express his appreciation to Mansir John Varley atYellowstone National Park for his time and Petrie and Thom Minner at the World Foundation for willingness to share important insights on the challenges Environment and Development for their research and facing national park and other conservation area manage - editorial support and contributions for this chapter and to ment in the ï?? ï?? st century . References B ï쳌² ï쳌¯ ï쳌£ ï쳌« T.D . ï?? ï?? ï?? ï?? . The value of basic research : Discovery n . and sp . n . , a non - sporulating extreme thermophile . of Thermus aquaticus and other extreme thermophiles . Journal of Bacteriology ï?? ï?? : ï?? ï?? ï?? â?? ï?? ï?? . Genetics ï?? ï?? ï?? : ï?? ï?? ï?? ï?? â?? ï?? ï?? ï?? ï?? . K ï쳌¥ ï쳌­ ï쳌° ï쳌® ï쳌¥ ï쳌² E . ï?? ï?? ï?? ï?? . Upper temperature limit of life . Science B ï쳌² ï쳌¯ ï쳌£ ï쳌« T.D . ï?? ï?? ï?? ï?? . Early days in Yellowstone microbiology . ï?? ï?? ï?? : ï?? ï?? ï?? ï?? â?? ï?? ï?? ï?? ï?? . ASM News ï?? ï?? ( ï?? ) : ï?? ï?? ï?? . M ï쳌¡ ï쳌² ï쳌² ï쳌³ B . and M . M ï쳌¡ ï쳌¤ ï쳌© ï쳌§ ï쳌¡ ï쳌® . ï?? ï?? ï?? ï?? . Extremophiles . Scientific B ï쳌² ï쳌¯ ï쳌£ ï쳌« T.D . and H . F ï쳌² ï쳌¥ ï쳌¥ ï쳌º ï쳌¥ . ï?? ï?? ï?? ï?? . Thermus aquaticus gen . American April : ï?? ï?? â?? ï?? ï?? . Box 1 . Continued Conduct for Employees of the Executive Branch â?쳌 ( ï?? for any loss , claim , damage , or liability of any kind involv - ing an employee of the Collaborator arising in connection C.F.R . Parts ï?? ï?? ï?? ï?? and ï?? ï?? ï?? ï?? ) and Security Regulations , with this ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ , except to the extent that such loss , claim , hereby made part of this ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ , to the extent that these damage or liability arises from the negligence of ï쳌® ï쳌° ï쳌³ or its regulations prohibit private business activity or interest employees acting within the scope of their employment . incompatible with the best interests of the ï쳌µ ï쳌³ Department ï쳌® ï쳌° ï쳌³ shall be solely responsible for the payment of all of the Interior . claims for the loss of property , personal injury or death , ï?? ï?? . ï?? . ï?? . The Collaboratorâ??s Assigned Employees shall or otherwise arising out of any negligent act or omission comply with regulations that apply to ï쳌¹ ï쳌® ï쳌° employees of its employees in connection with the performance of with regard to disclosure of proprietary or procurement - work under this ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ as provided under the Federal sensitive information , refusal from any activities which Tort Claims Act . ï?? ï?? ï쳌µ ï쳌³ ï쳌£ § ï?? ï?? ï?? ï?? . may present a conflict of interest , including procurement ï?? ï?? . ï?? . ï?? . Technical Developments and Products . The or other actions in which the Collaborator may have an Collaborator holds the ï쳌µ ï쳌³ Government harmless and interest . The Collaboratorâ??sAssigned Employees may not indemnifies the Government for all liabilities , demands , represent the Collaborator or work for the Collaborator damages , expenses , and losses arising out of the use by in competing for award from any other Federal agency the Collaborator , or any party acting on its behalf or under during the term of the ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ ( see Article ï?? ï?? ) or exten - its authorization , of ï쳌® ï쳌° ï쳌³ â?? s research and technical develop - sion thereto . ments or out of any use , sale , or other disposition by the ï?? ï?? . ï?? . ï?? . The Collaboratorâ??s Assigned Employees are per - Collaborator , or others acting on its behalf or with its manently prohibited from representing or performing authorization , of products made by Collaborator using the activities for the Collaborator on any matters before ï쳌® ï쳌° ï쳌³ ï쳌® ï쳌° ï쳌³ â?? s technical developments . In respect to this Article , on which the Collaboratorâ??s employees worked at ï쳌¹ ï쳌® ï쳌° the Government shall not be considered an assignee or while assigned to this project . licensee of the Collaborator . This provision shall survive ï?? ï?? . ï?? . ï?? . The Collaboratorâ??s employees are prohibited from termination of this ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ . acting as Government employees , including making deci - ï?? ï?? . ï?? . ï?? . Collaborator agrees to maintain insurance in sions on behalf of the Government or performing inher - amounts reasonably customary in the industry and to pro - ently Governmental functions while working at ï쳌¹ ï쳌® ï쳌° . vide proof of liability insurance to ï쳌® ï쳌° ï쳌³ upon request . ï?? ï?? . ï?? . No Warranty . Except as provided in Title ï?? ï?? , United ï?? ï?? . ï?? . Force Majeur . Neither party shall be liable for any un - States Code , Section ï?? ï?? ï?? ï?? , the United States shall not be foreseeable event beyond its reasonable control not caused liable for the use or manufacture of any Invention made by the fault or negligence of such party , which causes such under this ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ nor for the infringement of any patent or party to be unable to perform its obligations under this copyright during the performance of this ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ . ï쳌® ï쳌° ï쳌³ makes ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ ( and which it has been unable to overcome by the no express or implied warranty as to any matter whatsoever , exercise of due diligence ) , including but not limited to flood , including the conditions of the research or any Invention or drought , earthquake , storm , fire , pestilence , lightening , and product , whether tangible or intangible , made or developed other natural catastrophes , epidemic , war , riot , civil dis - under this ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ , or the ownership , merchantability , or fit - turbance or disobedience , strikes , labor dispute , or failure , ness for a particular purpose of the research or any Invention threat of failure or sabotage of ï쳌¹ ï쳌® ï쳌° facilities , or any order or product . These provisions shall survive termination of or injunction made by a court or public agency . In the event the ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ . of the occurrence of such a force majeur event , the party ï?? ï?? . ï?? . Indemnification . unable to perform shall promptly notify the other party . It ï?? ï?? . ï?? . ï?? . Collaboratorâ??s Employees . The Collaborator shall further use its best efforts to resume performance as agrees to indemnify and hold harmless the ï쳌µ ï쳌³ Government quickly as possible and shall suspend performance only ï?? ï?? ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ Endnotes 1 4 Information about culture collections around the world as well as A section - by - section analysis is under preparation separately . For more information , contact the World Foundation for Environment specialized discussions about access and benefit sharing as it per - and Development in Washington DC . tains to genetic resources acquired by and from culture collections 5 may be obtained from the World Federation for Culture Collections See , e.g . , ï쳌µ ï쳌³ ï쳌¡ Department of the Interior ( National Park Service ) , ( http : / / wdcm.nig.ac.jp / wfcc ) . Natural Resource Year in Review ( ï?? ï?? ï?? ï?? ) , at page ï?? ï?? . 2 6 There are no comprehensive directories of such information for ï?? ï?? ï쳌µ ï쳌³ ï쳌£ ï?? ( ï?? ï?? ï?? ï?? ) . the ï쳌µ ï쳌³ ï쳌¡ . The nationâ??s size and complexity alone would require 7 See ï?? ï?? ï?? ï?? ï쳌® ï쳌° ï쳌³ Management Policies , Section ï?? . ï?? . ï?? . constant updating of obsolete information ( such as office addresses , 8 The term â?? plants and animals â?쳌 as used by ï쳌® ï쳌° ï쳌³ refers to the com - telephone numbers , and persons - in - charge ) . Nonetheless , relevant monly recognized kingdoms of living things and includes such information is widely available throughout the ï쳌µ ï쳌³ ï쳌¡ ( although legal groups as flowering plants , ferns , mosses , lichens , algae , fungi , and technical issues almost certainly require the assistance of a bacteria , mammals , birds , reptiles , amphibians , fishes , insects , lawyer or other specialist in the field ) . worms , crustaceans , as well as all microorganisms . 3 Information about the voluntary guidelines ( including the 9 Yellowstone National Park Organic Act , ï?? ï?? ï쳌µ ï쳌³ ï쳌£ ï?? ï?? ( ï?? ï?? ï?? ï?? ) . text ) may be obtained directly from the ï쳌£ ï쳌¢ ï쳌¤ Secretariat ( http : 10 / / www.biodiv.org ) . Permit ( dated ï?? ï?? August ï?? ï?? ï?? ï?? ) , signed by James B . Erwin , Capt . , Box 1 . Continued for such period of time as is necessary as result of the force by applicable Federal laws . majeur event . ï?? ï?? . ï?? . Entire Agreement . This ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ , consisting of the Statement of Work , AppendixA ( collection permits issued by ARTICLE 15 . MISCELLANEOUS TERMS AND ï쳌® ï쳌° ï쳌³ to Collaborator ) , and Appendix B , constitutes the entire CONDITIONS agreement between the parties concerning the subject matter ï?? ï?? . ï?? . Successors . Subject to the limitations stated in the hereto and supersedes any prior understanding or written or General Provisions , this ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ shall be a binding obliga - oral agreement relative to said matter . tion to the successors and permitted assignees of all the right , ï?? ï?? . ï?? . Headings . Titles and headings of the Sections and title and interest of each party hereto . Any such successor or Subsections of this ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ are for the convenience of refer - assignee of a partyâ??s interest shall expressly assume in writ - ences only and do not form a part of this ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ and shall in ing the performance of all the terms and conditions of this no way affect the interpretation thereof . ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ to be performed by said party . Any such assignment ï?? ï?? . ï?? . Amendments . If either party desires a modification in this shall not relieve the assignor of any of its obligations under ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ , the parties shall , upon reasonable notice of the pro - this ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ . posed modification by the party desiring the change , confer in ï?? ï?? . ï?? . Severability . The provisions of this ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ are severable good faith to determine the desirability of such modification . and in the event any of provisions of this ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ are deter - Such modification shall not be effective until a written amend - mined to be invalid or unenforceable by a court of competent ment is signed by all parties hereto by their representatives jurisdiction , such invalidity or unenforceability shall not in duly authorized to execute such amendment . any way affect the validity or enforceability of the remaining ï?? ï?? . ï?? ï?? . Assignment . Neither this ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ nor any rights or obli - provisions hereof , except that for so long as the Collaborator gations of any party hereunder shall be assigned or otherwise is receiving financial benefit from the use of a product , the transferred by either party without the prior written consent Collaborator agrees to provide royalty payments as provided of the other party , except that the Collaborator may assign , in Exhibit B . subject to the provisions of ï?? ï?? . ï?? , this ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ to the successors ï?? ï?? . ï?? . Waiver . Neither party may waive or release any of its or assigns a substantial portion of the Collaboratorâ??s business rights or interests in this ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ except in writing . Failure by interests to which this ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ directly pertains . either party to assert any rights or interests arising from any ï?? ï?? . ï?? ï?? . Notices . All notices pertaining to or required by breach or default of this ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ shall not be regarded as a this ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ shall be in writing and shall be directed to the waiver of any existing or future rights , interests , or claims . signatory ( s ) . ï?? ï?? . ï?? . Enforcement . Collaborator and ï쳌® ï쳌° ï쳌³ specifically ï?? ï?? . ï?? ï?? . Independent Contractors . The relationship of the par - acknowledge the right to pursue all legal and equitable ties to this ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ is that of independent contractors and not remedies necessary to cure any breach of their obligations as agents of each other or as joint venturers or partners . ï쳌® ï쳌° ï쳌³ under this ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ that are not satisfactorily resolved under shall maintain sole and exclusive control over its personnel this ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ . and operations . ï?? ï?? . ï?? . No Benefits . No member of , or delegate to the United ï?? ï?? . ï?? ï?? . Use of Name or Endorsements . States Congress , or resident commissioner , shall be admit - ï?? ï?? . ï?? ï?? . ï?? . The Collaborator shall not use the name of ï쳌¹ ï쳌® ï쳌° , ted to any share or part of this ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ , nor to any benefit that ï쳌® ï쳌° ï쳌³ or the Department of the Interior on any product or may arise therefrom ; but this provision shall not be construed service which is directly or indirectly related to either this to extend to this ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ if made with a corporation for its ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ or any patent license or assignment agreement general benefit . which implements this ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ without the prior approval of ï?? ï?? . ï?? . Governing Law . The construction validity , performance ï쳌® ï쳌° ï쳌³ . The Collaborator shall not publicize , or otherwise cir - and effect of this ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ for all purposes shall be governed culate , promotional material ( such as advertisements , sales ï?? ï?? ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : USA ï?? th Cavalry , Acting Superintendent , Yellowstone National Park It should be noted that Dr . Brock was affiliated with Indiana University ( not Wisconsin ) when T . aquaticus was first discovered ( copy on file at Yellowstone National Park ) . in ï?? ï?? ï?? ï?? ( not ï?? ï?? ï?? ï?? ) . 11 In ï?? ï?? ï?? ï?? , the ï쳌µ ï쳌³ ï쳌¡ Supreme Court ruled that a live , human - made 14 See , e.g . , â?? Yellowstoneâ??s Geysers Spout Valuable Micro - microorganism is patentable subject matter under the patent laws of Organisms â?쳌 , The Wall Street Journal , ï?? ï?? Aug . ï?? ï?? ï?? ï?? , at B ï?? . the ï쳌µ ï쳌³ ï쳌¡ . See Diamond v . Chakrabarty , ï?? ï?? ï?? ï쳌µ ï쳌³ ï?? ï?? ï?? ( ï?? ï?? ï?? ï?? ) . 15 12 See , e.g . , â?? Industries Exploit First Park â?쳌 , The Billings Gazette , ï?? It should be noted that the patent rights awarded in connection with Dec . ï?? ï?? ï?? ï?? ( â?? Gazette Opinion â?쳌 ) . Taq and the ï쳌° ï쳌£ ï쳌² process have been the subject of much dispute in 16 the ï쳌µ ï쳌³ ï쳌¡ and abroad . The issues associated with who owns what ï?? ï?? ï?? ï쳌µ ï쳌³ ï?? ï?? ï?? ( ï?? ï?? ï?? ï?? ) , at ï?? ï?? ï?? . rights to which inventions under what laws are very significant 17 Act of ï?? ï?? Feb . ï?? ï?? ï?? ï?? , Section ï?? , ï?? Stat . ï?? ï?? ï?? . to the issues of principal concern to this chapter ( the facts and 18 ï?? ï?? ï?? ï쳌µ ï쳌³ ï?? ï?? ï?? ( ï?? ï?? ï?? ï?? ) , at ï?? ï?? ï?? , quoting ï?? Writings of Thomas Jefferson circumstances surrounding access and use of genetic resources ) . ï?? ï?? â?? ï?? ï?? ( Washington ed . ï?? ï?? ï?? ï?? ) . 13 Testimony of D . Allan Bromley , Director , Office of Science and 19 Id . , at ï?? ï?? ï?? . Technology Policy , before the Committee on Science , Space , and 20 Technology , ï쳌µ ï쳌³ ï쳌¡ House of Representatives , ï?? ï?? February ï?? ï?? ï?? ï?? . Id . Box 1 . Continued brochures , press releases , speeches , still or motion pictures date specified herein , unless it is revised in accordance with or video , articles , manuscripts or other publications ) which paragraph ï?? ï?? . ï?? of this ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ . states or implies Governmental , Departmental , Bureau , ï?? ï?? . ï?? . Review Period . Notwithstanding paragraph ï?? ï?? . ï?? above , or ï쳌µ ï쳌³ Government employee endorsement of a product , the ï쳌® ï쳌° ï쳌³ Director shall have the opportunity to disapprove or service or position which the Collaborator represents . No require the modification of this ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ for a ï?? ï?? - day period be - release of information relating to this ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ may state or ginning on the date the agreement is presented to the Director imply that the Government approves of the Collaboratorâ??s by the Superintendent of ï쳌¹ ï쳌® ï쳌° , unless the agreement is signed work product , or considers the Collaboratorâ??s work product by the Director . to be superior to other products or services . SIGNATURE PAGE ï?? ï?? . ï?? ï?? . ï?? . The Collaborator must obtain prior ï쳌µ ï쳌³ Government SIGNATURES approval from ï쳌® ï쳌° ï쳌³ for any public information releases that In Witness Whereof , the parties have executed this ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ refer to the Department of the Interior , any bureau or em - on the dates set forth below . This ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ may be signed in ployee ( by name or title ) , or this ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ . The specific text , counterparts , each of which will be deemed to be an origi - layout , photographs , etc . of the proposed release must be nal . All such counterparts shall together constitute a single , submitted with the request for approval . executed instrument when all parties have so signed . Any ï?? ï?? . ï?? ï?? . ï?? By entering into this ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ , ï쳌® ï쳌° ï쳌³ does not directly communication or notice to be given shall be forwarded to or indirectly endorse any product or service provided or to the respective addresses listed below . be provided by the Collaborator , its successors , assignees , or licensees . For ï쳌® ï쳌° ï쳌³ : ï?? ï?? . ï?? ï?? . Compliance with Law . The operations of the _____________________________ ____________ Collaborator will be conducted in all material respects in Robert Stanton Date accordance with all applicable laws , ratified treaties , inter - Director national agreements and conventions , regulations , guidelines National Park Service and other requirements of all governmental bodies having For ï쳌¹ ï쳌® ï쳌° : jurisdiction over the Collaborator . The Collaborator shall _____________________________ _____________ have all material licenses ( including a radioactivity license ) , Michael Finley Date permits , orders or approvals from governmental bodies Superintendent required for the conduct of its business . All such licenses , Yellowstone National Park permits , approvals or other requirements shall be in full force and there shall exist no violations or breaches of any such Mailing Address for Notices : domestic licenses , permits , approvals or other requirements . Office of the Superintendent Collaborator shall be in compliance in all material respects Yellowstone National Park with all limitations , restrictions , conditions , standards , prohi - P.O . Box ï?? ï?? ï?? bitions , requirements , obligations , schedules and timetables Yellowstone National Park , Wyoming ï?? ï?? ï?? ï?? ï?? contained in any applicable law or in any plan , order , decree , For ï쳌£ ï쳌¯ ï쳌¬ ï쳌¬ ï쳌¡ ï쳌¢ ï쳌¯ ï쳌² ï쳌¡ ï쳌´ ï쳌¯ ï쳌² : judgment , notice or demand letter issued , entered , promul - _____________________________ ____________ gated or approved thereunder . Terrance J . Bruggeman Date ARTICLE ï?? ï?? . DURATION OF AGREEMENT AND Chairman , President & Chief Executive Officer EFFECTIVE DATE . Diversa Corporation ï?? ï?? . ï?? . Effective Date . This ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ shall enter into force as of Mailing Address for Notices : the date of the last signature of the parties as shown on the Diversa Corporation signature page , and will terminate five years from the effective ï?? ï?? ï?? ï?? ï?? Sorrento Valley Road date . In no case will this ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ extend beyond the ending San Diego , California ï?? ï?? ï?? ï?? ï?? ï?? ï?? ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ 21 Id . , at ï?? ï?? ï?? . impacts of implementing this provision is being conducted by ï쳌® ï쳌° ï쳌³ pursuant to ï쳌® ï쳌¥ ï쳌° ï쳌¡ . 22 The patent laws create enforceable monopoly rights in patented 46 ï?? ï?? ï?? ï?? ï쳌® ï쳌° ï쳌³ Management Policies , Chapter ï?? : Natural Resource inventions . If there is demand for the patented invention in the Management , at Section ï?? . ï?? ( â?? Studies and Collections â?쳌 ) . market , the monopoly rights created and guaranteed by the patent law can generate significant economic power for the patent holder 47 Id . , at Section ï?? . ï?? . ï?? ( â?? Independent Studies â?쳌 ) . that typically translates into significant revenue or other earnings . 48 Id . , at Section ï?? . ï?? . ï?? ( â?? Collection Associated with the Development 23 ï?? ï?? ï?? ï쳌µ ï쳌³ ï?? ï?? ï?? ( ï?? ï?? ï?? ï?? ) , at ï?? ï?? ï?? , quoting Funk Brothers Seed Co . v . Kalo of Commercial Products â?쳌 ) . Inoculant Co . , ï?? ï?? ï?? ï쳌µ ï쳌³ ï?? ï?? ï?? ( ï?? ï?? ï?? ï?? ) , at ï?? ï?? ï?? . 49 ï?? ï?? ï?? ï?? ï쳌® ï쳌° ï쳌³ Management Policies , Chapter ï?? : Use of the Parks , 24 ï쳌µ ï쳌³ ï쳌¡ Patent and Trademark Office ( ï쳌µ ï쳌³ ï쳌° ï쳌´ ï쳌¯ ) , Chapter ï?? ï?? ï?? ï?? at Section ï?? . ï?? ï?? ( â?? Natural and Cultural Studies Research and Patentability â?? Section ï?? ï?? ï?? ï?? Patentable Subject Matter â?? Living Collection Activities â?쳌 ) . Subject Matter ( available at http : / / www.uspto.gov / web / offices / pac / 50 â?? Culture collections â?쳌 are institutions that acquire , preserve , and mpep / documents / ï?? ï?? ï?? ï?? . htm # sect ï?? ï?? ï?? ï?? ) . distribute biological samples and related information , technology , 25 Id . and intellectual property to research scientists in academia as well 26 as industry . There are an estimated ï?? ï?? ï?? culture collections located ï쳌µ ï쳌³ ï쳌° ï쳌´ ï쳌¯ , Patents Granted by Class by Year ( dated ï?? ï?? Dec . ï?? ï?? ï?? ï?? ) . in approximately ï?? ï?? countries around the world . The largest is con - 27 Id . sidered to be the American Type Culture Collection ( ï쳌¡ ï쳌´ ï쳌£ ï쳌£ ) , which 28 Id . is headquartered in facilities on the campus of George Mason 29 JEM Ag Supply dba Farm Advantage v . Pioneer Hi - Bred Intâ??l , ï?? ï?? ï?? University near Manassas , Virginia , not far from Washington , DC . ï쳌µ ï쳌³ ï?? ï?? ï?? ( ï?? ï?? ï?? ï?? ) . ï쳌¡ ï쳌´ ï쳌£ ï쳌£ currently holds approximately ï?? ï?? different microbial samples 30 originally collected from Yellowstone , plus several other biological This distinction also has been recognized and upheld by the federal samples acquired from other national parks in the ï쳌µ ï쳌³ ï쳌¡ and abroad . judiciary specifically in the national park context . See Edmonds 51 Institute , et al . v . Babbitt , et al . , ï?? ï?? F . Supp . ï?? d ï?? ï?? ( ï쳌¤ ï쳌¤ ï쳌£ ï?? ï?? ï?? ï?? ) â?? Gazette Opinion â?쳌 , The Billings Gazette , ï?? Dec . ï?? ï?? ï?? ï?? . ( Memorandum Opinion and Order dismissing plaintiffs â?? claims 52 ï?? ï?? ï쳌µ ï쳌³ ï쳌£ ï?? ï?? ï?? ï?? a ( d ) ( ï?? ï?? ï?? ï?? ) . with prejudice ) ( â?? This interpretation accords with the fact that 53 S . Rep . No . ï?? ï?? ï?? , ï?? ï?? th Cong . , ï?? d Sess . ( ï?? ï?? ï?? ï?? ) , at page ï?? ï?? . The fed - patent rights derive from human ingenuity brought to bear on eral judiciary has upheld the designation of Yellowstone National scientific specimens , not the specimens themselves . â?쳌 ) . Park as a â?? federal laboratory â?쳌 under the ï쳌¦ ï쳌´ ï쳌´ ï쳌¡ . See Edmonds 31 National Parks Omnibus Management Act of ï?? ï?? ï?? ï?? , ï?? ï?? ï쳌µ ï쳌³ ï쳌£ ï?? ï?? ï?? ï?? Institute , et al . v . Babbitt , et al . , ï?? ï?? F . Supp . ï?? d ï?? ï?? ( ï쳌¤ ï쳌¤ ï쳌£ ï?? ï?? ï?? ï?? ) ( ï?? ï?? ï?? ï?? ) . ( Memorandum Opinion and Order dismissing plaintiffs â?? claims 32 See ï?? ï?? Fed . Reg . ï?? ï?? ï?? ï?? ï?? ( ï?? ï?? June ï?? ï?? ï?? ï?? ) . In August ï?? ï?? ï?? ï?? , the with prejudice ) ( â?? [ T ] he court finds that defendants [ Department National Park Service published new proposals relating to admin - of the Interior / National Park Service ] have provided a reasoned istering the scientific research and collecting permits authorized basis for concluding that the broad , statutorily - assigned definition under ï?? ï?? ï쳌£ ï쳌¦ ï쳌² ï?? . ï?? ( ï?? ï?? ï?? ï?? ) . See ï?? ï?? Fed . Reg . ï?? ï?? ï?? ï?? ï?? ( ï?? ï?? Aug . ï?? ï?? ï?? ï?? ) . encompasses Yellowstoneâ??s extensive research facilities . â?쳌 ) . The revised standardized guidelines became effective in ï?? ï?? ï?? ï?? ( http : 54 S . Rep . No . ï?? ï?? ï?? , ï?? ï?? th Cong . , ï?? d Sess . ( ï?? ï?? ï?? ï?? ) , at page ï?? . / / science.nature.nps.gov / permits / index.html ) . 55 See Edmonds Institute , et al . v . Babbitt , et al . , ï?? ï?? F . Supp . ï?? d ï?? ï?? 33 ï?? ï?? ï쳌£ ï쳌¦ ï쳌² ï?? . ï?? ( a ) ( ï?? ï?? ï?? ï?? ) . ( ï쳌¤ ï쳌¤ ï쳌£ ï?? ï?? ï?? ï?? ) ( Memorandum Opinion and Order dismissing plain - 34 ï?? ï?? Fed . Reg . ï?? ï?? ï?? ï?? ï?? , ï?? ï?? ï?? ï?? ï?? ( ï?? ï?? June ï?? ï?? ï?? ï?? ) . tiffs â?? claims with prejudice ) ( â?? [ T ] he court finds that defendants 35 [ Department of the Interior / National Park Service ] reasonably ï?? ï?? ï쳌£ ï쳌¦ ï쳌² ï?? . ï?? ( ï?? ï?? ï?? ï?? ) . construed Park regulations and concluded that the ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ was 36 ï?? ï?? ï쳌£ ï쳌¦ ï쳌² ï?? . ï?? ( e ) ( ï?? ï?? ï?? ï?? ) . consistent with their requirements . â?쳌 ) . 37 ï?? ï?? ï쳌£ ï쳌¦ ï쳌² ï?? . ï?? ( b ) ( ï?? ï?? ï?? ï?? ) . 56 S . Rep . No . ï?? ï?? ï?? , ï?? ï?? th Cong . , ï?? d Sess . ( ï?? ï?? ï?? ï?? ) , at page ï?? ï?? . 38 The revised standardized â?? Application Procedures and 57 In March ï?? ï?? ï?? ï?? , a federal court in Washington ruled that royalty Requirements for Scientific Research and Collecting Permits â?쳌 rates negotiated in ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ s and research - related licensing agree - guidelines became effective in ï?? ï?? ï?? ï?? and are published and made ments by the National Institutes of Health with private sector firms available through the internet . See http : / / science.nature.nps.gov / are subject to confidential treatment under Exemption ï?? of the permits / index.html . Research permit applications can be prepared Freedom of Information Act . See Public Citizen Health Research and filed electronically throughout the entire ï쳌µ ï쳌³ ï쳌¡ ï쳌® ï쳌° ï쳌³ system . Group v . National Institutes of Health ( opinion by Judge Colleen 39 Id . Kollar - Kotelly dated ï?? ï?? March ï?? ï?? ï?? ï?? ) . 40 58 Id . The term â?? net â?쳌 was defined in the ï쳌¹ ï쳌® ï쳌° - Diversa ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ to mean â?? to - 41 tal gross receipts for sales by Collaborator [ Diversa ] , its licensees See Edmonds Institute , et al . v . Babbitt , et al . , ï?? ï?? F . Supp . ï?? d ï?? ï?? or sublicensees of Product ( s ) and copyrighted works created using ( ï쳌¤ ï쳌¤ ï쳌£ ï?? ï?? ï?? ï?? ) ( Memorandum Opinion and Order dismissing plain - the results of research under this ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ , and from otherwise mak - tiffs â?? claims with prejudice ) ( â?? The record discloses that defendants ing Product ( s ) available to others without sale , whether invoiced [ Department of the Interior / National Park Service ] have provided or not , less returns and allowances actually granted , packing costs , a thoughtful and rational approach to research conducted on Park insurance costs , freight out , taxes and excise duties imposed on the resources â?¦ . Thus , in accord with these fundamental principles , the transaction ( if separately invoiced ) , and the wholesaler and cash Park Service has interpreted its regulations only to allow research - discounts in amounts customary in the trade . No deductions shall ers to study , not sell , Park resources â?¦ . [ T ] he court finds that be made for commissions paid to individuals , whether they be with defendants reasonably construed Park regulations â?¦ . â?쳌 ) . independent sales agencies or regularly employed by Collaborator , 42 See â?? General Permit Conditions â?쳌 at http : / / science.nature.nps.gov / its licensee or sublicensees , or for the costs of collections . â?쳌 permits / index / html . 59 See Edmonds Institute , et al . v . Babbitt , et al . , ï?? ï?? F . Supp . ï?? d ï?? ï?? 43 See â?? General Permit Conditions â?쳌 at Section ï?? ( â?? Collection ( ï쳌¤ ï쳌¤ ï쳌£ ï?? ï?? ï?? ï?? ) ( Memorandum Opinion and Order dismissing plain - of specimens ( including materials ) â?쳌 ) , available at http : / / tiffs â?? claims with prejudice ( â?? [ C ] ontrary to plaintiffs â?? assertion , science.nature.nps.gov / permits / index.html . neither the ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ nor its Scope of Work authorizes Diversa to take 44 Id . any natural materials from Yellowstone . Rather , the ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ outlines 45 See id . It should be noted that an analysis of the environmental the rights and responsibilities of Yellowstone and Diversa with re - ï?? ï?? ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : USA spect to information and inventions developed after the conclusion Congressional intent expressed in the National Parks Omnibus of research specimen collection and analysis . â?쳌 ( Emphasis supplied Management Act of ï?? ï?? ï?? ï?? . See Edmonds Institute , et al . v . Babbitt , by the court . ) ) . et al . , ï?? ï?? F . Supp . ï?? d ï?? ï?? ( ï쳌¤ ï쳌¤ ï쳌£ ï?? ï?? ï?? ï?? ) ( Memorandum Opinion and 60 Order dismissing plaintiffs â?? claims with prejudice ( â?? [ T ] he court Id . , ( â?? If the court were to find that the ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ was improper under the relevant statutes , Diversa could still collect specimens under a finds that defendants [ Department of the Interior / National Park research permit , as it has since ï?? ï?? ï?? ï?? . The only â?? albeit critical â?? Service ] properly determined that the ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ was consistent with difference would be that Yellowstone could not share in any of the the governing statutes because it would produce direct , concrete potential benefits from Diversaâ??s research . Instead , the positive benefits to the Parkâ??s conservation efforts by affording greater gains from the research would go exclusively to Diversa . â?쳌 ) . scientific understanding of Yellowstoneâ??s wildlife , as well as 61 See Edmonds Institute , et al . v . Babbitt , et al . , ï?? ï?? F . Supp . ï?? d ï?? ï?? monetary support for Park programs and ï?? ï?? â?¦ [ T ] he far - reaching ( ï쳌¤ ï쳌¤ ï쳌£ ï?? ï?? ï?? ï?? ) . terms of the Parks Management Act reinforce the conclusion that 62 the Yellowstone - Diversa ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ is proper . â?쳌 ) . See Edmonds Institute , et al . v . Babbitt , et al . , ï?? ï?? F . Supp . ï?? d ï?? ( ï쳌¤ ï쳌¤ ï쳌£ ï?? ï?? ï?? ï?? ) . 65 See Edmonds Institute , et al . v . Babbitt , et al . , ï?? ï?? F . Supp . ï?? d ï?? 63 See Edmonds Institute , et al . v . Babbitt , et al . , ï?? ï?? F . Supp . ï?? d ï?? ï?? , at ( ï쳌¤ ï쳌¤ ï쳌£ ï?? ï?? ï?? ï?? ) ( Memorandum Opinion and Order suspending the ï?? ï?? ( ï쳌¤ ï쳌¤ ï쳌£ ï?? ï?? ï?? ï?? ) . ï쳌¹ ï쳌® ï쳌° - Diversa ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ pending a showing of ï쳌® ï쳌¥ ï쳌° ï쳌¡ compliance ( dated 64 March ï?? ï?? , ï?? ï?? ï?? ï?? ) ) . Since entry of the ï?? ï?? March ï?? ï?? ï?? ï?? Order , the The federal judiciary has ruled that the ï쳌¹ ï쳌® ï쳌° - Diversa ï쳌£ ï쳌² ï쳌¡ ï쳌¤ ï쳌¡ was consistent with the parkâ??s conservation mission , as well as with Court dismissed plaintiffs â?? case with prejudice . ï?? ï?? ï?? ï?? ï?? ï?? 9 Australia : Draft Regulations on Access and Benefit Sharing Sally Petherbridge Australiaâ??s status as a megadiverse nation ( one of sev - on Biological Diversity concluded : enteen in the world ) is well known . Australia has the â?¦ whilst the potential of Australiaâ??s biodiversity as a planetâ??s second highest number of reptile species , is fifth source of food and useful pharmaceutical , medicinal and in flowering plant species , and tenth in amphibian species . industrial products has scarcely been realized , attention The Australian continent and its islands have an estimated is now being given to development of novel Australian ï?? ï?? % of the worldâ??s marsupials . More significant , how - bio - resources and bio - techniques ( E ï쳌® ï쳌¶ ï쳌© ï쳌² ï쳌¯ ï쳌® ï쳌­ ï쳌¥ ï쳌® ï쳌´ ever , is the high percentage of organisms that occur only A ï쳌µ ï쳌³ ï쳌´ ï쳌² ï쳌¡ ï쳌¬ ï쳌© ï쳌¡ ï?? ï?? ï?? ï?? ) . in Australia . Seven families of mammals and twelve of Growing awareness of the potential value ofAustraliaâ??s flowering plants are endemic , giving Australia far more biodiversity for such uses ( as well as the importance of endemic families than any other country . At the species ensuring that Australia benefits in economic terms from level , the mean percentage of endemism for terrestrial ver - such uses , while ensuring that they are ecologically tebrates and flowering plants is ï?? ï?? % . Australiaâ??s marine sustainable ) has resulted in the development of a draft biological diversity , like that of the land , is notable for its regulatory scheme for access to , and benefit sharing high proportion of endemic species . In the south of the from , such resources . The proposed scheme , has been continent , about ï?? ï?? to ï?? ï?? % of the species in most marine the subject of extensive consultations with stakeholders groups are considered to be endemic . On the basis of such and interested parties . The regulations are expected to be statistics about biodiversity , Australiaâ??s National Report to the Fourth Conference of the Parties to the Convention enacted in ï?? ï?? ï?? ï?? . Draft Access and Benefit - Sharing Regulations On ï?? September ï?? ï?? ï?? ï?? , Senator Robert Hill , Australiaâ??s provide for the control of access to biological resources then - Minister for the Environment and Heritage , re - in Commonwealth areas â?쳌 and , further , that the regulations leased the draft Environment Protection and Biodiversity may contain provisions about the equitable sharing of the Conservation Amendment Regulations of ï?? ï?? ï?? ï?? for a benefits arising from the use of these resources ; the facili - 1 period of public comment ending on ï?? October ï?? ï?? ï?? ï?? . tation of access ; the right to deny access ; the granting of 2 These regulations will be made under section ï?? ï?? ï?? of the access ; and the terms and conditions of such access . Environment Protection and Biodiversity Conservation The objects of the ï쳌¥ ï쳌° ï쳌¢ ï쳌£ ï쳌¡ are , among other things : Act of ï?? ï?? ï?? ï?? ( ï쳌¥ ï쳌° ï쳌¢ ï쳌£ ï쳌¡ ) which came into effect on ï?? ï?? July â?¢ To provide for the protection of the environment , ï?? ï?? ï?? ï?? . Section ï?? ï?? ï?? , which is headed â?? Control of access to biological resources , â?쳌 states that â?? the regulations may especially those aspects of the environment that are ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ matters of national environmental significance ; marine areas over which the Australian government has 4 sovereignty . Therefore , the regulations will not apply to â?¢ To promote ecologically sustainable development the States and Territories which have , in varying degrees , through the conservation and ecologically sustain - their own legislation and / or policies governing access to able use of natural resources ; and biological resources . Proposals for a â?? nationally consis - 3 â?¢ To promote the conservation of biodiversity . tent â?쳌 system of access to biological resources are discussed further below . The inclusion of section ï?? ï?? ï?? in the ï쳌¥ ï쳌° ï쳌¢ ï쳌£ ï쳌¡ reflects , The Inquiry was unable to obtain a comprehensive list therefore , not only the importance of facilitating access of â?? Commonwealth areas â?쳌 but was assisted in identifying to biological resources , but also the importance of ensuring major areas which either have been or are likely to be that access is ecologically sustainable . of interest to bioprospectors through submissions from The access and benefit - sharing scheme in the draft Australian government agencies with responsibility for regulations essentially reflects the scheme recommended land and / or marine management . â?? Areas â?쳌 thereby identi - by the report of the Inquiry into Access to Biological fied included three terrestrial national parks , Australiaâ??s Resources in Commonwealth Areas ( Inquiry ) ( V ï쳌¯ ï쳌µ ï쳌­ ï쳌¡ ï쳌² ï쳌¤ Antarctic Territory , the Great Barrier Reef Marine Park , ï?? ï?? ï?? ï?? ) . The Inquiry recommended regulations which would Commonwealth land in Norfolk Island , lands managed by require a party seeking access to biological resources in government agencies such as the Department of Defense , Commonwealth areas to apply for an access permit from 5 and the Commonwealthâ??s marine area . the Minister for the Environment and Heritage . As the regulatory agency under the scheme , the Department of Structure and Purpose of the Regulations the Environment and Heritage would assess the applica - tion , in consultation with any other relevant Australian The draft regulations provide for a new Part ( Part ï?? A ) to government agency , and make a recommendation to the be inserted into the existing regulations under the ï쳌¥ ï쳌° ï쳌¢ ï쳌£ ï쳌¡ Minister to grant or refuse the permit . and for amendments to Part ï?? ï?? of these regulations ( Part While the assessment process for the permit was un - ï?? ï?? covers all permits that may be issued under the ï쳌¥ ï쳌° ï쳌¢ ï쳌£ ï쳌¡ ) . derway , the applicant would be required to negotiate with While this structure has the advantage of avoiding repeti - the holder ( or owner ) of the resources a benefit - sharing tion of elements that are common to all permits under the contract which covered the commercial and other aspects Act , it may also have the undesirable effect of making the of the agreement ( in particular , matters such as up front access scheme more difficult to comprehend , as it is not set payments for samples , royalties , and protection of indig - out in a self - contained Part under the regulations . enous knowledge ) . The Inquiry proposed that the contract The purpose of the regulations is â?? to provide for the be based on a model contract which the Inquiry report control of access to biological resources in Commonwealth outlined and recommended be developed and agreed upon areas â?쳌 by : promoting the conservation of resources in by governments , industry , indigenous organizations , and those areas , including their ecologically sustainable use ; other stakeholders . ensuring the equitable sharing of benefits arising from The Inquiry recommended that the regulations provide their use by providing for benefit - sharing agreements that the Minister may issue the access permit on being sat - between persons seeking access and access providers ; isfied , among other things , that environmental assessment recognizing the special knowledge held by indigenous ( if required ) has been undertaken and the process com - people about biological resources ; establishing an access pleted ; submissions from interested persons and bodies regime designed to provide certainty , and minimize cost , have been taken into account ; and there is a benefit - sharing for people seeking access ; and seeking to ensure that the contract between the parties which addresses the follow - social and economic benefits arising from their use accrue ing major issues : prior informed consent ; mutually agreed 6 to Australia . terms ; adequate benefit - sharing arrangements , including The regulations define â?? access to biological resources â?쳌 protection for and valuing of indigenous knowledge ; and as â?? the taking of biological resources of native species the use of benefits for biodiversity conservation in the area for : conservation , commercial application or industrial from which the resource was obtained . The benefit - sharing application of , or research on , any genetic resources , or contract would only have effect if the Minister issued an biochemical compounds , comprising or contained in the access permit ( V ï쳌¯ ï쳌µ ï쳌­ ï쳌¡ ï쳌² ï쳌¤ ï?? ï?? ï?? ï?? ) . The Inquiry and its report biological resources . â?쳌 Examples of what this might involve , are discussed in more detail below . quoted from the Explanatory Memorandum of the ï쳌¥ ï쳌° ï쳌¢ ï쳌£ ï쳌¡ , are included : â?? Collecting living material , analyzing and Proposed Coverage of the Regulations sampling stored material , exporting material for purposes including taxonomic research , conservation , research and Australia has a federal system of government , compris - 7 potential commercial product development . â?쳌 In addition , ing the national government , six State governments , and the regulations provide that â?? a person is taken to have ac - two self - governing Territories . The regulations will apply cess to biological resources if there is a reasonable prospect to â?? Commonwealth areas â?쳌 which , expressed simply , are lands owned or leased by the Australian government and that [ the resources ] will be subject to conservation , com - ï?? ï?? ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : A ï쳌µ ï쳌³ ï쳌´ ï쳌² ï쳌¡ ï쳌¬ ï쳌© ï쳌¡ 8 mercial application , industrial application or research . â?쳌 on Plant Genetic Resources ( ï?? ï?? ï?? ï?? ) , applies . This provision allows a declaration to be sought with The meaning of access to biological resources is further respect to biological resources covered by the clarified by reference to activities which it does not cover . International Treaty on Plant Genetic Resources These include : for Food and Agriculture ( ï쳌© ï쳌´ ï쳌° ï쳌§ ï쳌² ï쳌¦ ï쳌¡ ) , if Australia â?¢ The taking of biological resources by indigenous 10 decided to become a party to this agreement . people other than for a purpose mentioned in sub - regulation ( ï?? ) or in the exercise of their native title Ex Situ Collections rights and interests ( addresses concerns that access might limit indigenous peopleâ??s existing uses of With respect to ex situ resources , the Inquiry identified col - these resources ) ; lections held byAustralian government agencies such as the â?¢ Access to human remains ( responds to concerns Australian National Botanic Gardens , the Commonwealth expressed by indigenous people that indigenous Scientific and Industrial Research Organization ( ï쳌£ ï쳌³ ï쳌© ï쳌² ï쳌¯ ) , remains not be accessible and implements a recom - and the Australian Institute of Marine Science ( ï쳌¡ ï쳌© ï쳌­ ï쳌³ ) . mendation to this effect in V ï쳌¯ ï쳌µ ï쳌­ ï쳌¡ ï쳌² ï쳌¤ ( ï?? ï?? ï?? ï?? ) ) ; Although these collections are under Australian govern - â?¢ Taking public resources , other than for a purpose ment jurisdiction by virtue of the legislation governing mentioned in subregulation ( ï?? ) ( makes clear that these bodies , as well as by the definition of Commonwealth normal commercial and other uses of biological areas in the ï쳌¥ ï쳌° ï쳌¢ ï쳌£ ï쳌¡ , the ownership status of particular col - resources such as fishing or plant production are lections ( or parts of them ) is less clear . This was an issue not regulated under these regulations . â?? Taking of particular concern to ï쳌£ ï쳌³ ï쳌© ï쳌² ï쳌¯ which expressed concern public resources â?쳌 includes : fishing for commerce that , without clear legal title , its rights to deal with its or recreation , game or charter fishing , or collecting collections might be challenged ( V ï쳌¯ ï쳌µ ï쳌­ ï쳌¡ ï쳌² ï쳌¤ ï?? ï?? ï?? ï?? ) . ï쳌£ ï쳌³ ï쳌© ï쳌² ï쳌¯ broodstock for aquaculture ; harvesting wildflowers ; houses several major national collections which include taking wild animals for plants or food ; collecting the Australian National Herbarium , the Tree Seed Center , peat or firewood ; taking essential oils from wild and insect , wildlife and marine collections . 9 plants ; and collecting seeds for propagation ) ; With respect to this issue , the Inquiry received legal and advice that : â?¢ Access specified in a declaration under regulation It is not possible to make any definitive , general ï?? A . ï?? ï?? . statement as to the ownership of all ex situ collections of biological resources . Each collection would have Regulation ï?? A . ï?? ï?? provides exemptions for specified to be considered on its own merits having regard to biological resources . Under this regulation , the Minister a range of factors , including the ownership , if any , of may declare that the permit provisions do not apply to the material when it was in situ and the circumstances biological resources : under which the material passed into the possession of â?¢ If they are held in a collection by a Australian the ex situ holder , including the terms and conditions government department or agency , and if there are of any relevant agreement , or any relevant legislation reasonable grounds to believe that access to the ( V ï쳌¯ ï쳌µ ï쳌­ ï쳌¡ ï쳌² ï쳌¤ ï?? ï?? ï?? ï?? ) . biological resources is administered consistently In recognition of these difficulties , the Voumard report with the purpose of the regulations ; recommended that the Minister for the Environment and â?¢ If there are reasonable grounds to believe that Heritage ask his department to discuss with holders of access to the resources is controlled by another such collections , the value of a combined request for legal national , self - governing Territory , or State law , con - advice on ownership issues and that , subject to the advice sistent with the purpose of the regulations ( avoids obtained , the Minister consider any recommendation for duplication of any access arrangements applying legislative amendment to resolve outstanding issues by in a Commonwealth area ) ; the holders of the collections ( V ï쳌¯ ï쳌µ ï쳌­ ï쳌¡ ï쳌² ï쳌¤ ï?? ï?? ï?? ï?? ) . To date , â?¢ If an international agreement to which Australia is however , the holders of these collections have not pursued a party , such as the ï쳌¦ ï쳌¡ ï쳌¯ International Undertaking the issue . The Main Characteristics of the Draft Regulations on Access and Benefit Sharing The draft regulations set out provisions with respect to the cross - referencing between different provisions , but this information required for access permits and the content of was unavoidable from a drafting point of view . However , benefit - sharing agreements , as well as detailed provisions by indicating the administrative procedures which will be covering the way in which permit applications and benefit - followed , including timeframes to promote expeditious de - sharing agreements are to be assessed and environmental cision - making , and the information and factors which must assessment , if required , is to be carried out . Unfortunately , be taken account of in decision - making , the draft regula - parts of the latter are somewhat difficult to read , requiring tions do have the merit of promoting the transparency and ï?? ï?? ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ accountability of the decision - making process . Fortunately , able benefit - sharing arrangements , including protection for , recognition of and valuing of any indigenous knowl - the regulations are written in Plain English with little or no 18 edge given by the access provider . If the access provider legal jargon , although they do encompass some complex 11 is the owner of indigenous peopleâ??s land or a native title areas of the law such as ownership / sovereignty and native holder for the area , the access provider must have given title law . It should be noted that , although the regulations 19 informed consent to the agreement . refer to the Minister of the Environment and Heritage as Detailed requirements for ensuring informed consent the decision - maker , the ï쳌¥ ï쳌° ï쳌¢ ï쳌£ ï쳌¡ enables the Minister to by the access provider follow . In assessing whether in - delegate his or her â?? powers or functions â?쳌 to an officer or formed consent was given , the Minister must consider the employee of the department.An identical provision applies following matters : to the Secretary of the Department of the Environment 12 and Heritage . Detailed administrative arrangements for â?¢ Whether the applicant gave the provider adequate the handling of access applications can be expected to be information about the application and the require - developed once the regulations are enacted . ments of the regulations and engaged in reasonable negotiations with the provider about the agree - ment ; Access Permits â?¢ Whether the provider was given adequate time to A person may have access to biological resources only consider the application , including time to consult in accordance with a permit in force under Part ï?? ï?? of the with relevant people , and , if the provider is the 13 regulations under the ï쳌¥ ï쳌° ï쳌¢ ï쳌£ ï쳌¡ This provision includes an owner of indigenous peopleâ??s land , to consult with explanatory note that the Minister may issue a permit only the traditional owners and to negotiate the agree - if the applicant has given the Minister a copy of each ben - ment ; efit - sharing agreement . Proposed amendments to Part ï?? ï?? â?¢ Whether the provider is the owner of indigenous set out the information which will be required of persons peopleâ??s land and represented by a land council seeking access to biological resources in Commonwealth and , if so , the views of the land council about the areas . This includes : the name of the Australian govern - matters in paragraphs a ) and b ) ; ment department or agency which administers the area â?¢ If access is sought to the resources of an area for in which access is proposed ; if the provider is not the which native title exists , the views of any represen - Australian government , the name of the provider ; the re - tative Aboriginal and Torres Strait Islander body sources to which access is sought ; where the resources are ; within the meaning of the Native Title Act of ï?? ï?? ï?? ï?? the amount of the resources that will be collected ; the use for the area about the matters in paragraphs a ) and the applicant intends to make of them ; details of any other b ) ; and person for whose benefit access is sought or who proposes â?¢ Whether the access provider has received indepen - to use the samples ; how the access is to be undertaken , 20 dent legal advice about the regulation . including details of the vehicles and equipment to be used ; the nature and extent of the likely environmental impacts Assessment of Benefit - Sharing of the access ; whether the applicant thinks that further access to the resources will be sought ; details of any other Agreements application by the applicant for a permit under this Part ; The regulations then set out the procedures which must be and information about the progress of any negotiations followed once the Secretary has received the benefit - shar - with the access provider about sharing the benefits arising ing agreement ( s ) and the permit application . The Secretary 14 from their use . must give a report to the Minister within ï?? ï?? days of their receipt . The Minister may extend this time if needed for Benefit - Sharing Agreements consulting any persons who may have information rel - 21 evant to the application or the agreement . In assessing the An applicant for a permit must enter into a benefit - sharing agreement , the Minister may consult with any Australian agreement with each access provider for the resources . government department or agency that may have relevant An explanatory note states that there may be more than information ; must take into account the provisions of the one access provider for biological resources ; for example , model benefit - sharing agreement , if any , and any variations if a Commonwealth area is subject to native title , the from it ; and must consider whether , under the regulations Australian government and the native title holders are both requiring consultation with the owners of land leased by the 15 access providers . If the access provider is the Australian Commonwealth , reasonable benefit - sharing arrangements government , the Secretary to the Australian government 22 and informed consent have been complied with . department that has administrative authority for the Commonwealth area may , on behalf of the Australian 16 Environmental Assessment government , enter into the benefit - sharing agreement . 17 The agreement takes effect only if a permit is issued . Detailed requirements for environmental assessment are The benefit - sharing agreement must provide for reason - also included . There are three ways in which this may ï?? ï?? ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : A ï쳌µ ï쳌³ ï쳌´ ï쳌² ï쳌¡ ï쳌¬ ï쳌© ï쳌¡ occur : on the basis of the permit application ; through Assessment of Permits â?? Environmental assessment by public notice â?쳌 , the require - Proposed amendments to Part ï?? ï?? of the regulations set ments for which are set out in the regulations ; or through out the requirements for the assessment of permits . If the the environmental assessment provisions set out in the proposed access is a â?? controlled action â?쳌 , the Minister ï쳌¥ ï쳌° ï쳌¢ ï쳌£ ï쳌¡ itself . The regulations provide that environmental must decide whether to issue a permit within ï?? ï?? days assessment by public notice may apply to an application after approval of the action . If the access proposed is not for a permit under the regulations if the proposed access is 23 a â?? controlled action â?쳌 , the Minister must decide whether to not a controlled action . Assessment of an application by issue a permit within ï?? ï?? days of receiving the Secretaryâ??s public notice is required if there are reasonable grounds for report and any comments and responses from the environ - the Minister to believe that the proposed access is likely to mental assessment by public notice process . In making have environmental impacts that are likely to be more than 24 this decision , the Minister must take into account these negligible . This is not defined nor are there any guidelines documents , the views of any owner of land leased to the to assist the Ministerâ??s decision . However , it would appear Australian government , the views of any Australian gov - to encompass activities which pose a lesser threat to the ernment department or agency consulted by the Minister , environment than activities requiring environmental as - the assessment of the benefit - sharing agreement , and any sessment under the ï쳌¥ ï쳌° ï쳌¢ ï쳌£ ï쳌¡ . In the latter case ( a â?? controlled 28 other matters that the Minister thinks are relevant . The action â?쳌 ) , an action will require approval from the Minister Minister may seek more information from any person who if it has , will have , or is likely to have â?? a significant impact may have information relevant to the application if he or on a matter of national environmental significance â?쳌 . The she believes there is not sufficient information to make a matters of national environmental significance are : World 29 decision . Heritage properties ; Ramsar wetlands of international im - Several circumstances are then set out which must be portance ; listed threatened species and communities ; mi - present for the Minister to issue a permit . These are that gratory species protected under international agreements ; the applicant has entered into a benefit - sharing agree - nuclear actions ; the Commonwealth marine environment ; ment with each access provider ; the applicant has given and national heritage . The Administrative guidelines on the Minister a copy of each benefit - sharing agreement ; the significance assist in determining whether an action should Minister believes , on reasonable grounds , that some of the be referred to the Minister for a decision on whether an benefits will , if practicable , be used for biodiversity con - approval is required ( E ï쳌® ï쳌¶ ï쳌© ï쳌² ï쳌¯ ï쳌® ï쳌­ ï쳌¥ ï쳌® ï쳌´ A ï쳌µ ï쳌³ ï쳌´ ï쳌² ï쳌¡ ï쳌¬ ï쳌© ï쳌¡ ï?? ï?? ï?? ï?? ) . servation in the area from where the resources were taken ; If the Minister decides , however , that environmental the proposed access is consistent with any relevant plan assessment by public notice is required , the draft regula - 30 for a Commonwealth reserve , and the proposed access tions set out in detail the consultation procedures and will , taking into account the precautionary principle , be timeframes which apply . Within ï?? ï?? days after receiving ecologically sustainable and consistent with the conser - the application , the Minister must inform the applicant and vation of Australiaâ??s biological diversity . In addition for the applicant must then give the Minister a summary of access in Kakadu , Uluru - Kata Tjuta , or Booderee National the likely environmental impacts of the proposed access Parks , the proposed access must be consistent with any ( there is no timeframe for this activity ) . Within ï?? ï?? days of 31 relevant lease . receiving the summary , the Minister must invite anyone ( by public notice ) and each person registered under Regulation ï?? A . ï?? ï?? to comment on the likely impacts , and within ï?? Requirements Arising days after the end of the period given in the invitation for from Native Title Rights comments , the Minister must give the applicant a copy of Following consultations with , and legal advice from , the comments received . Finally , the applicant must give the Native Title Division of the Australian governmentâ??s the Minister a response to these comments ( again , there is Attorney Generalâ??s Department , several provisions were no timeframe for this activity but , presumably , it is in the 25 included in the draft regulations to protect the rights of na - applicantâ??s interests to respond expeditiously ) . tive title holders under the Native Title Act of ï?? ï?? ï?? ï?? . These Requirements for the consultation register are then set include clarification that access to biological resources out . At intervals of not more than ï?? ï?? months , the Minister does not include the taking of resources by indigenous must publish a notice inviting applications from persons people in the exercise of their native title rights and inter - who want to be registered , to be told of applications for 32 ests . The definition of â?? access provider â?쳌 recognizes that access permits where environmental assessment by public 33 26 native title holders for the area may be access providers notice is required . The Minister is also required to keep and that there may be more than one access provider for a register of information about permits . The register must an area . For example , if a Commonwealth area is subject be available for public inspection ; however , information is to native title , the Australian government and native title not be included in it if the Minister believes the informa - 34 holders are both access providers . The regulations also tion is culturally sensitive or , if disclosed , could damage state that an agreement may be both a benefit - sharing a personâ??s commercial interests , result in a risk to the 27 environment , or harm the national interest . agreement and an indigenous land - use agreement under ï?? ï?? ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ 35 the Native Title Act . Further amendments require the procedures required by law in connection with the making Secretary / head of the Australian government department of the decision were not observed ; the making of the deci - or agency that has entered into a benefit - sharing agreement sion was an improper exercise of the power conferred by with the applicant to advise the Minister whether he or she the enactment under which it was made ; the decision was thinks that issuing the permit would be an invalid future induced or affected by fraud ; and there was no evidence 36 act under the Native Title Act . The Minister may issue or other material to justify the making of the decision . An a permit only if satisfied that it would not be an invalid â?? improper exercise of power â?쳌 includes taking an irrelevant 37 future act . One basis for being satisfied is that there is an consideration into account ; failing to take a relevant con - indigenous land use agreement under the Native Title Act sideration into account ; exercising a discretionary power for the area in which native titleholders have consented to in accordance with a rule or policy without regard to the 38 the issue of the permit . merits of a particular case ; an exercise of power that is so unreasonable that no reasonable person would have so Review / Appeals Processes exercised the power ; and exercising power in such a way The Inquiry report recommended that the parties to the 39 that the result is uncertain . contract be able to seek merits review of the Ministerâ??s decision not to grant an access permit ( V ï쳌¯ ï쳌µ ï쳌­ ï쳌¡ ï쳌² ï쳌¤ ï?? ï?? ï?? ï?? ) . It Enforcement of the Regulations was decided during the drafting phase , however , that merits Enforcement of the access regulations will be the responsi - review would not be available . Nevertheless , procedural bility of the Department of the Environment and Heritage review is available through the courts under the ï?? ï?? ï?? ï?? which manages compliance with the ï쳌¥ ï쳌° ï쳌¢ ï쳌£ ï쳌¡ . Fifty penalty Administrative Decisions ( Judicial Review ) Act . Possible units are set for contravening the regulation ( ï?? A . ï?? ï?? ) which grounds include the following : a breach of natural justice 40 occurred in connection with the making of the decision ; requires a permit for access to biological resources . The Process Leading to the Development of the Access Legislation vation status of any species or population ; The Inquiry â?? Ensuring that the social and economic benefits Senator the Hon . Robert Hill , then - Minister for the of the use of biological resources derived Environment and Heritage , announced an inquiry into from Australiaâ??s biological diversity accrue to access to biological resources in Commonwealth areas Australia . on ï?? ï?? June ï?? ï?? ï?? ï?? . This reflected the governmentâ??s ï?? ï?? ï?? ï?? The terms of reference stated further that the scheme election commitment to introduce regulations to regulate â?? should operate in a manner that promotes certainty for access to genetic resources in Commonwealth areas industry â?쳌 . Finally , consistent with the objective of the 41 ( V ï쳌¯ ï쳌µ ï쳌­ ï쳌¡ ï쳌² ï쳌¤ ï?? ï?? ï?? ï?? ) . Following the receipt of advice from ï쳌¥ ï쳌° ï쳌¢ ï쳌£ ï쳌¡ , the scheme should : his department as to how the process might be conducted , â?¢ Promote a cooperative approach to the protection the Minister formally initiated the Inquiry on ï?? ï?? December and management of the environment involving ï?? ï?? ï?? ï?? . governments , the community , land - holders , and The Inquiryâ??s terms of reference stated that the Inquiry indigenous peoples . was to advise on a scheme that could be implemented through regulations under section ï?? ï?? ï?? of the ï쳌¥ ï쳌° ï쳌¢ ï쳌£ ï쳌¡ to â?¢ Recognize the role of indigenous people in the â?? provide for the control of access to biological resources in conservation and ecologically sustainable use of Commonwealth areas â?쳌 . The terms of reference stated that Australiaâ??s biodiversity . the scheme should take into account the following : â?¢ Promote the use of indigenous peoples â?? knowledge of biodiversity with the involvement of , and in â?¢ Australiaâ??s obligations under the Convention on cooperation with , the owners of that knowledge . Biological Diversity ( ï쳌£ ï쳌¢ ï쳌¤ ) , including the obligation to encourage the equitable sharing of benefits aris - The Inquiry was conducted by a solicitor from South ing from the utilization of biological resources . The Australia , John Voumard . The reference group established scheme should particularly focus on the equitable to assist him comprised an environmental law specialist , sharing of benefits arising from the utilization of an industry representative , an indigenous representative , an traditional knowledge , innovations , and practices intellectual property specialist , and a representative from ( article ï?? ( j ) ) . 42 the scientific community . The reference group met on â?¢ The objectives of the National Strategy for the four occasions , in January , April , June , and July ï?? ï?? ï?? ï?? . Conservation of Australiaâ??s Biodiversity , such as : In announcing the Inquiry , Senator Hill invited submis - â?? Ensuring that the collection of biological re - sions by ï?? March ï?? ï?? ï?? ï?? . The Inquiry was advertised in the sources for research and development purposes national press and the major newspaper of each State , the does not adversely affect the viability or conser - Australian Capital Territory , and the Northern Territory ï?? ï?? ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : A ï쳌µ ï쳌³ ï쳌´ ï쳌² ï쳌¡ ï쳌¬ ï쳌© ï쳌¡ during January ï?? ï?? ï?? ï?? . The Inquiry secretariat also sent out Access toAustraliaâ??s Biological Resources â?? A Discussion Paper ( ï쳌¤ ï쳌° ï쳌­ ï쳌£ ï?? ï?? ï?? ï?? ) . In May ï?? ï?? ï?? ï?? , following advice from approximately ï?? ï?? ï?? notices inviting submissions , mainly ï쳌¡ ï쳌® ï쳌º ï쳌¥ ï쳌£ ï쳌£ , First Ministers established the Commonwealth to biotechnology organizations ( based on a mailing list State Working Group ( ï쳌£ ï쳌³ ï쳌· ï쳌§ ) . provided by Biotechnology Australia ) , as well as to in - The ï쳌£ ï쳌³ ï쳌· ï쳌§ completed its discussion paper in October digenous land councils in the Northern Territory , Western ï?? ï?? ï?? ï?? . The paper was subsequently released and eight Australia , and Queensland , environment groups , and over - submissions received by April ï?? ï?? ï?? ï?? . An important part seas biotechnology companies . The Inquiry received ï?? ï?? of this public consultation process was the Roundtable submissions ( V ï쳌¯ ï쳌µ ï쳌­ ï쳌¡ ï쳌² ï쳌¤ ï?? ï?? ï?? ï?? ) , although , as a result of the Discussion on Access to Australiaâ??s Genetic Resources tight deadline for submissions ( seven weeks from public held in Canberra on ï?? ï?? March ï?? ï?? ï?? ï?? . Although the ï쳌£ ï쳌³ ï쳌· ï쳌§ advertising ) , several submissions were not received until paper was the most detailed discussion of issues and May . In addition to receiving submissions , the Inquiry principles to date , subsequent work on access issues was held two public hearings , one in Canberra on ï?? ï?? May ï?? ï?? ï?? ï?? hampered by the lack of specific direction in its recommen - and the other in Brisbane on ï?? June ï?? ï?? ï?? ï?? . In some cases dations , both in relation to the form access systems might evidence was presented by telephone ( from Melbourne take and the bureaucratic / political processes required to and from north Queensland ) . Extensive consultations were take the work forward . also held , most significantly with the traditional owners 43 Australian government agencies with an interest of the three national parks and their representatives . The in access issues and a working group , comprising the Inquiry was required to report to the Minister by ï?? ï?? June Departments of Environment and Heritage andAgriculture , ï?? ï?? ï?? ï?? . The Chair sought a short extension , submitting the Fisheries , and Forestry , and representatives of State and Inquiry Report on ï?? August ï?? ï?? ï?? ï?? . Territory Governments , continued to meet , but without a clear focus or political and bureaucratic support , little prog - Studies Prior to the Inquiry ress was made . This situation changed , however , in mid - Although the Inquiry was undoubtedly the most signifi - cant step in the development of access and benefit - shar - ing regulations , it was preceded by several studies which , Table ï?? . Key steps in the development of the draft regu - while inconclusive in policy / legislative terms , were useful lations on access and benefit sharing in identifying many of the major issues involved in access Date Steps issues and developing general principles to guide further September ï?? ï?? ï?? ï?? Australia signs the Convention on work ( Table ï?? ) . The Inquiry report drew on and acknowl - Biological Diversity . 44 edged the work of its predecessors . December ï?? ï?? ï?? ï?? Australia ratifies the Convention on Australia signed the ï쳌£ ï쳌¢ ï쳌¤ on ï?? June ï?? ï?? ï?? ï?? . In February Biological Diversity . ï?? ï?? ï?? ï?? , the Australian and New Zealand Environment and October ï?? ï?? ï?? ï?? The Commonwealth State Working Group Conservation Council ( ï쳌¡ ï쳌® ï쳌º ï쳌¥ ï쳌£ ï쳌£ ) , a consultative group of Paper is released . Australian government , State , and Territory environment May ï?? ï?? ï?? ï?? Biotechnology Australia is established . 45 ministers , produced a report to First Ministers on the June ï?? ï?? ï?? ï?? The Minister for the Environment and Implementation of and Implications of Ratification of the Heritage announces an inquiry into access Convention on Biological Diversity ( ï쳌¡ ï쳌® ï쳌º ï쳌¥ ï쳌£ ï쳌£ ï?? ï?? ï?? ï?? ) . to biological resources in Commonwealth In discussing Article ï?? ï?? of the ï쳌£ ï쳌¢ ï쳌¤ , Access to Genetic areas . Resources , ï쳌¡ ï쳌® ï쳌º ï쳌¥ ï쳌£ ï쳌£ ( ï?? ï?? ï?? ï?? ) noted : December ï?? ï?? ï?? ï?? The Minister formally initiates the Inquiry ( V ï쳌¯ ï쳌µ ï쳌­ ï쳌¡ ï쳌² ï쳌¤ ï?? ï?? ï?? ï?? ) . â?¦ the control of access to genetic resources is an issue August ï?? ï?? ï?? ï?? The Inquiry Chair submits the Inquiry of national importance requiring urgent attention . . . report to the Minister . the introduction of procedures governing access . . . September ï?? ï?? ï?? ï?? The Minister publicly releases the Inquiry would enable Australia to take full advantage of the report . opportunities provided by this article and also to protect August ï?? ï?? ï?? ï?? The Bailey report ( Bioprospecting : our interests . Discoveries changing the future ) is Two further reports followed in quick succession . released . In March ï?? ï?? ï?? ï?? ï쳌¡ ï쳌® ï쳌º ï쳌¥ ï쳌£ ï쳌£ released a paper on Access to September ï?? ï?? ï?? ï?? The Minister releases the draft regulations Australiaâ??s Genetic Resources in which it noted : on access and benefit sharing for public comment . Currently , under existing legislation and guidelines December ï?? ï?? ï?? ï?? Responsibility for the development of it is possible to export a large range and volume of a nationally consistent approach to the genetic resources for use in overseas research and utilization of genetic and biochemical development without appropriate returns to Australia resources is given to the Natural Resource ( ï쳌¡ ï쳌® ï쳌º ï쳌¥ ï쳌£ ï쳌£ ï?? ï?? ï?? ï?? ) . Management Ministerial Council . Also in March , the Office of the Chief Scientist in the Octoer ï?? ï?? ï?? ï?? Final comments on the draft regulations Department of the Prime Minister and Cabinet released are received . ï?? ï?? ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ ï?? ï?? ï?? ï?? , with the establishment of Biotechnology Australia were also received in response to presentations by Access and the announcement of the Inquiry . Biotechnology Taskforce members at the International Marine Biology Australia was established in the Department of Industry , Conference ( Townsville , September ï?? ï?? ï?? ï?? ) and the an - Science , and Resources in May ï?? ï?? ï?? ï?? , but comprised nual symposium of the Natural Products Group of the five departments : Industry , Science , and Resources ; Royal Australian Chemical Institute at the University of Environment and Heritage ; Agriculture , Fisheries , and New South Wales ( Sydney , October ï?? ï?? ï?? ï?? ) . Copies of the Forestry ; Health and Aged Care ; and Education , Training , report were sent to everyone who had made a submission and Youth Affairs . It was overseen by a Council compris - to the Inquiry , as well as to others who had expressed an ing the Ministers responsible for these departments and a interest in its work ( this included a Chinese government Committee of the Secretaries ( executive heads ) of these delegation comprising representatives of national and departments . The Inquiry was one of the major activities provincial environment agencies which had met with the under Biotechnology Australiaâ??s Access Work Program Department of the Environment and Heritage and several and was funded through this Program . other organizations involved in access issues during a visit Australiaâ??s National Biotechnology Strategy , released to Australia in August ï?? ï?? ï?? ï?? ) . in July ï?? ï?? ï?? ï?? , included as an objective , the â?? development of Key Australian government agencies were invited to measures to enhance access to biological resources â?쳌 and , comment , not only on the report , but also on the drafting among strategies to meet that objective , the need to address instructions for the proposed regulations . On ï?? ï?? July ï?? ï?? ï?? ï?? issues of access to biological resources in Commonwealth the Minister sent drafting instructions to his counterparts areas through regulations under the ï쳌¥ ï쳌° ï쳌¢ ï쳌£ ï쳌¡ ; matters involv - for comment by early August ï?? ï?? ï?? ï?? . Comments on the ing indigenous people and their ownership of biological re - drafting instructions were reflected in the draft regulations sources ; and work with the States and Territories to achieve which were released for public comment on ï?? September nationally consistent regimes on access ( C ï쳌¯ ï쳌­ ï쳌­ ï쳌¯ ï쳌® ï쳌· ï쳌¥ ï쳌¡ ï쳌¬ ï쳌´ ï쳌¨ ï?? ï?? ï?? ï?? . TheAccess Taskforce then held further consultations ï쳌¯ ï쳌¦ A ï쳌µ ï쳌³ ï쳌´ ï쳌² ï쳌¡ ï쳌¬ ï쳌© ï쳌¡ ï?? ï?? ï?? ï?? ) . with government , industry , indigenous , and environment The Inquiry ( and its subsequent implementation ) also stakeholders . There were thirty - eight submissions on the drew extensively on international developments . The draft regulations , the final one being received in May Inquiry examined existing and proposed access schemes ï?? ï?? ï?? ï?? . in other countries , a summary of developments in Costa Rica , the Philippines , the United States , and Brazil be - Towards a Nationally Consistent System ing included in the report ( V ï쳌¯ ï쳌µ ï쳌­ ï쳌¡ ï쳌² ï쳌¤ ï?? ï?? ï?? ï?? ) . A member For several years before the Inquiry was established , there of its reference group , Elizabeth Evans - Illidge , attended had been attempts to address the issue of establishing a the first meeting of the Panel of Experts on Access and nationally consistent system of access arrangements for Benefit - Sharing in Costa Rica in October ï?? ï?? ï?? ï?? . TheAccess theAustralian , State , and Territory governments . The terms Taskforce ( the Inquiry secretariat ) also participated in sev - of reference for the ï쳌£ ï쳌³ ï쳌· ï쳌§ ( ï?? ï?? ï?? ï?? ) paper had required it to eral other international meetings on access and related issues , by contributing to theAustralian Government briefs â?? investigate and report on action required to develop a 46 for them and , in some cases , through its attendance . national approach to access to Australiaâ??s biological re - sources â?쳌 . The ï쳌£ ï쳌³ ï쳌· ï쳌§ observed that a â?? national approach â?쳌 , understood as a common system of regulations and per - Consultations Following the Release of mits across Australia controlling access to all biological the Inquiry Report and of the Draft Access resources wherever they may occur and whoever owns Regulations them , was a position which would be â?? extremely difficult to achieve , both administratively and politically â?쳌 . It con - When Senator Hill publicly released the Inquiry report ( ï?? cluded , therefore , that it would be more appropriate to September ï?? ï?? ï?? ï?? ) , he wrote to the BiotechnologyAustralia focus on a â?? nationally consistent approach â?쳌 ( my emphasis ) Ministers inviting their comments on it . From this date which â?? seeks agreement to broad principles while allow - until the draft regulations were released a year later , the ing jurisdictions the freedom to apply those principles in Department of the Environment and Heritage held exten - ways which meet their needs and which take into account sive consultations with Biotechnology Australia depart - their existing legislative / regulatory frameworks â?쳌 ( ï쳌£ ï쳌³ ï쳌· ï쳌§ ments , other agencies within their Ministers â?? portfolios ï?? ï?? ï?? ï?? ) . The ï쳌£ ï쳌³ ï쳌· ï쳌§ paper then addressed the benefits of a ( for example , ï쳌£ ï쳌³ ï쳌© ï쳌² ï쳌¯ and Intellectual Property Australia 47 nationally consistent approach and set out â?? principles for â?쳌 ( ï쳌© ï쳌° ï쳌¡ ) in the Industry , Science and Resources portfolio ) , and â?? desirable features â?쳌 of a nationally consistent access other interested Australian government departments such management scheme ( ï쳌£ ï쳌³ ï쳌· ï쳌§ ï?? ï?? ï?? ï?? ) . as the Department of Foreign Affairs and Trade , and of - Although the terms of reference of the Inquiry did not ficials of some State and Territory Government depart - include consideration of a nationally consistent approach , ments . Consultations were conducted through a series of State and Territory Governments were invited to make meetings between the Access Taskforce and interested submissions and the Inquiry Chair and / or secretariat held agencies , followed by analysis of written comments on the scheme proposed in the Inquiry report . Comments meetings with State Government agencies . The Inquiry re - ï?? ï?? ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : A ï쳌µ ï쳌³ ï쳌´ ï쳌² ï쳌¡ ï쳌¬ ï쳌© ï쳌¡ port reflected the views of the governments of Queensland , between various jurisdictions to suit their own needs â?쳌 , and SouthAustralia , Victoria , WesternAustralia , theAustralian it noted the SouthAustralian governmentâ??s reference to the Capital Territory , and Norfolk Island , concluding that â?? frustratingly long time taken to establish policy and the â?? most States and Territories support a nationally consis - jurisdictional and legislative framework â?쳌 ( B ï쳌¡ ï쳌© ï쳌¬ ï쳌¥ ï쳌¹ ï?? ï?? ï?? ï?? ) . tent approach â?쳌 and noting that â?? some support â?쳌 had been The Bailey Report also noted the Inquiryâ??s work on this expressed for the Commonwealth State Working Group , issue and commented that the â?? wide - ranging consultative â?? although this is tempered by concern about a continuing process â?쳌 planned for the draft regulations was a â?? useful lack of progress â?쳌 ( V ï쳌¯ ï쳌µ ï쳌­ ï쳌¡ ï쳌² ï쳌¤ ï?? ï?? ï?? ï?? ) . The report made three approach to facilitating the development of nationally significant recommendations : first , that the Environment consistent arrangements â?쳌 ( B ï쳌¡ ï쳌© ï쳌¬ ï쳌¥ ï쳌¹ ï?? ï?? ï?? ï?? ) . Finally , quot - Minister endorse the ï쳌£ ï쳌³ ï쳌· ï쳌§ principles ; second , that further ing Cerylid Biosciences that â?? what would be helpful consultations be held with State and Territory Governments would be to make it easier to know who are the bodies to address the broader issue of a nationally consistent ap - that you need to talk to â?쳌 , the Committee concluded that proach across jurisdictions ; and , third , that the Minister it was â?? important to have a single point of information review the function of the ï쳌£ ï쳌³ ï쳌· ï쳌§ and consider steps neces - about the arrangements for applying for access permits sary to increase the involvement of key stakeholders and anywhere inAustralia â?쳌 . It added that it was also â?? important ensure that any future work done by that body was under - that the permit system be streamlined , for example , with taken with defined outcomes and within agreed timeframes a single permit application acceptable to all jurisdictions ( V ï쳌¯ ï쳌µ ï쳌­ ï쳌¡ ï쳌² ï쳌¤ ï?? ï?? ï?? ï?? ) . In the meantime , as noted above , the and agencies â?쳌 ( B ï쳌¡ ï쳌© ï쳌¬ ï쳌¥ ï쳌¹ ï?? ï?? ï?? ï?? ) . National Biotechnology Strategy , released in July ï?? ï?? ï?? ï?? , Two recommendations followed : first , that the supported the Inquiry reportâ??s recommendations by adopt - Department of the Environment and Heritage , â?? in con - ing as one of its objectives â?? the development of measures sultation with state and territory agencies : develop an to enhance access to Australian biological resources â?쳌 and electronic gateway to information about access arrange - included as a strategy to achieve this objective : â?? Work with ments in all jurisdictions and take a lead in coordinating the States and Territories to achieve nationally consistent the development of a simplified , streamlined system of regimes on access â?쳌 ( C ï쳌¯ ï쳌­ ï쳌­ ï쳌¯ ï쳌® ï쳌· ï쳌¥ ï쳌¡ ï쳌¬ ï쳌´ ï쳌¨ ï쳌¯ ï쳌¦ A ï쳌µ ï쳌³ ï쳌´ ï쳌² ï쳌¡ ï쳌¬ ï쳌© ï쳌¡ applying for permits â?쳌 and second , that the departments of the Environment and Heritage and Agriculture , Fisheries , ï?? ï?? ï?? ï?? ) . and Forestry â?? give a high priority to finishing the regula - The next significant support for a nationally consis - tions on access to biological resources and the sharing of tent system ( as well as the draft access regulations ) came benefits from them and working with state and territory from the report of the House of Representatives Standing governments to establish nationally consistent arrange - Committee on Primary Industries and Regional Services ments â?쳌 ( B ï쳌¡ ï쳌© ï쳌¬ ï쳌¥ ï쳌¹ ï?? ï?? ï?? ï?? ) . ( B ï쳌¡ ï쳌© ï쳌¬ ï쳌¥ ï쳌¹ ï?? ï?? ï?? ï?? ) . The terms of reference of the Bailey AttheinitiativeoftheSouthAustralian , Queensland , and Report , referred to the Committee by the Minister for Australian governments , a conference of Commonwealth , Agriculture , Fisheries and Forestry on ï?? October ï?? ï?? ï?? ï?? , State , and Territory government representatives , was held were to to discuss work towards a nationally consistent system . The â?¦ inquire into and report on the following areas , with Bio - Access Forum met in Adelaide , South Australia , on particular emphasis on the opportunities in rural ï?? November ï?? ï?? ï?? ï?? . On ï?? ï?? December ï?? ï?? ï?? ï?? , responsibility and regional Australia : the contribution towards the for the establishment of a nationally consistent approach development of high technology knowledge industries to the utilization of genetic and biochemical resources based on bioprospecting , bioprocessing and related was given to the Land , Water , and Biodiversity Committee biotechnologies ; impediments to growth of these new industries ; the capacity to maximize benefit through established under the aegis ofAustraliaâ??s Natural Resource intellectual property rights and other mechanisms to Management Ministerial Council ( ï쳌® ï쳌² ï쳌­ ï쳌­ ï쳌£ ) . The ï쳌® ï쳌² ï쳌­ ï쳌­ ï쳌£ , support development of these industries in Australia ; which comprises Australian , State , and Territory gov - and the impacts on and benefits to the environment ernment Environment and Agriculture Ministers , was ( B ï쳌¡ ï쳌© ï쳌¬ ï쳌¥ ï쳌¹ ï?? ï?? ï?? ï?? ) . established in June ï?? ï?? ï?? ï?? to promote the sustainable use of Australiaâ??s natural resources , replacing ï쳌¡ ï쳌® ï쳌º ï쳌¥ ï쳌£ ï쳌£ , which The Committee received ï?? ï?? submissions from orga - had been responsible for the ï쳌£ ï쳌³ ï쳌· ï쳌§ ( ï?? ï?? ï?? ï?? ) paper discussed nizations such as the Department of the Environment and above . Thus the Land , Water , and Biodiversity Committee Heritage and several others , both public and private , which effectively took over responsibility for work commenced , had also made submissions to the Voumard Inquiry . but not completed , by ï쳌¡ ï쳌® ï쳌º ï쳌¥ ï쳌£ ï쳌£ on the development of a In discussing a nationally consistent access regime , the nationally consistent system of access . Responsibility for Bailey Report observed that the Committee â?? was told re - this task rested with a joint Australian government / State peatedly of the need to establish a nationally consistent ac - task group chaired by a senior official of the Australian cess regime for Australiaâ??s biological resources â?쳌 ( B ï쳌¡ ï쳌© ï쳌¬ ï쳌¥ ï쳌¹ government Department of the Environment and Heritage . ï?? ï?? ï?? ï?? ) . It quoted from ï쳌£ ï쳌³ ï쳌© ï쳌² ï쳌¯ â?? s submission that , as a result The task group aimed to conclude development of a nation - of â?? significant variations in both policy objectives and ally consistent approach for adoption by the ï쳌® ï쳌² ï쳌­ ï쳌­ ï쳌£ at its administrative systems between all jurisdictions â?쳌 , there is a â?? real risk of intentional bioprospectors â?? shopping â?? next meeting in October ï?? ï?? ï?? ï?? . ï?? ï?? ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ The benefit of this approach was that it placed the benefit - sharing agreement with a biodiscovery entity under management of Australiaâ??s extensive genetic resources which the State gives the entity the right to use native bio - into the mainstream of significant attempts by Australian logical material or intellectual property derived from that governments , particularly since the establishment of the material for biodiscovery if the material was taken from Natural Heritage Trust in ï?? ï?? ï?? ï?? , to address the management State land or waters under a collection authority or was of the countryâ??s natural resources in an integrated manner sourced from that material , and the entity agrees to pay which acknowledges the seriousness of the threats facing amounts , including royalties , and provide other benefits Australiaâ??s land , water resources , and biodiversity . of biodiscovery . On ï?? ï?? October ï?? ï?? ï?? ï?? the ï쳌® ï쳌² ï쳌­ ï쳌­ ï쳌£ agreed to a set of The ï쳌¥ ï쳌° ï쳌¡ chief executive may establish a compliance fourteen principles to underpin the development or review code for taking native biological material under a collec - of legislative , administrative , or policy frameworks for a tion authority . The code may provide for : minimum stan - nationally consistent approach in each jurisdiction ( ï쳌® ï쳌² ï쳌­ ï쳌­ ï쳌£ dards for taking the material to ensure the sustainability ï?? ï?? ï?? ï?? ) . In the announcement released by the ï쳌® ï쳌² ï쳌­ ï쳌­ ï쳌£ sev - of the Stateâ??s native biological resources ; measures for eral days later , the Council Chair and Federal Minister minimizing the impact of taking the material ; and regu - for Agriculture , Fisheries , and Forestry , the Hon . Warren lating activities ( for example , the use of vehicles ) in land Truss , MP , said , â?? It is our responsibility to ensure that or waters from where the material is taken . The ï쳌¥ ï쳌° ï쳌¡ chief [ access to and use of resources ] are undertaken in an eco - executive may also establish collection protocols for taking logically sustainable way and that the community shares particular native biological material under a collection au - in the benefits that come from making resources available . thority ; taking native biological material from a particular Importantly , this approach provides greater certainty to area ; or using a particular collection technique for taking industry and encourages continued investment in biodis - native biological material . covery research and development . This is a worldâ??s first Other issues covered by the Bill include the require - for Australia and it marks us as a desirable location for ment to keep a register of collection authorities ; provision biodiscovery investment over coming years . â?쳌 for the ï쳌© ï쳌© ï쳌¥ Minister to publish a model benefit - sharing The Government of Queensland was the first state gov - agreement ; penalties for offenses such as taking mate - ernment to release draft legislation for public comment . rial without a collection authority ; provision for review The release of the exposure draft of the Biodiscovery Bill of decisions ; and definitions of terms such as â?? minimal 48 ï?? ï?? ï?? ï?? in mid - ï?? ï?? ï?? ï?? for comment by ï?? August ï?? ï?? ï?? ï?? fol - quantity â?쳌 . A criticism that has been made of the Bill is that lowed the release of the Queensland Biodiscovery Policy it only requires a benefit - sharing agreement when collec - Discussion Paper in ï?? ï?? ï?? ï?? ( Q ï쳌µ ï쳌¥ ï쳌¥ ï쳌® ï쳌³ ï쳌¬ ï쳌¡ ï쳌® ï쳌¤ G ï쳌¯ ï쳌¶ ï쳌¥ ï쳌² ï쳌® ï쳌­ ï쳌¥ ï쳌® ï쳌´ tions are made in State land or waters . Benefit sharing is ï?? ï?? ï?? ï?? ) . The Bill is expected to be enacted in ï?? ï?? ï?? ï?? . The main not compulsory where collections are made from native purposes of the Bill are to facilitate access by biodiscov - title ( exclusive possession ) or private land . ery entities to minimal quantities of Queenslandâ??s native In December ï?? ï?? ï?? ï?? the Government of Western biological resources for biodiscovery ; encourage the devel - Australia released a consultation paper , A Biodiversity opment in Queensland of value - added biodiscovery ; and Conservation Act for Western Australia . The paper stated ensure that Queensland , for the benefit of all persons in the that the new Act would include a licensing regime for State , obtains a fair and equitable share in the benefits of terrestrial bioprospecting activities that will ensure that : the biodiscovery . These purposes are achieved by provid - biological resources are used in an ecologically sustainable ing for a regulatory framework for taking and using native manner and biodiversity is protected ; benefits arising from biological resources in a sustainable way for biodiscovery ; the exploitation of WesternAustraliaâ??s biological resources a contractual framework for benefit - sharing agreements ; a are shared with the Western Australian community ; and compliance code and collection protocols ; and monitoring Aboriginal peopleâ??s native title and intellectual property and enforcement of compliance with the Bill . rights are recognized and protected ( G ï쳌¯ ï쳌¶ ï쳌¥ ï쳌² ï쳌® ï쳌­ ï쳌¥ ï쳌® ï쳌´ ï쳌¯ ï쳌¦ The Bill requires that applications for a collection au - W ï쳌¥ ï쳌³ ï쳌´ ï쳌¥ ï쳌² ï쳌® A ï쳌µ ï쳌³ ï쳌´ ï쳌² ï쳌¡ ï쳌¬ ï쳌© ï쳌¡ ï?? ï?? ï?? ï?? ) . The paper sought comments thority be made to the chief executive of the Queensland by ï?? March ï?? ï?? ï?? ï?? . Environment Protection Agency ( ï쳌¥ ï쳌° ï쳌¡ ) . The collection au - In November ï?? ï?? ï?? ï?? , the Department of Conservation thority allows the holder to enter and take minimal quanti - and Land Management released a table summarizing com - 49 ties of stated native biological material for biodiscovery ments received on the discussion paper The Department in State land or waters ; on private land ( with the written summarized submissions on the issue of bioprospecting consent of the owner ) ; on native title land where there is as follows : exclusive possession , if a registered indigenous land use Many submissions expressed the view that further agreement allows the authority to be issued ; and from col - community consultation is required on the issue of lections held by the Queensland Department of Primary Bioprospecting â?¦ the Act should provide the power Industries , the Queensland Museum , and the Queensland for the Minister to make regulations about this matter , Herbarium with the organizationâ??s written consent . and the Government engage the community on how The Bill also provides that the Queensland Information Bioprospecting should be dealt with . A number of and Innovation Economy ( ï쳌© ï쳌© ï쳌¥ ) Minister may enter into a submissions commented that provisions and funds for ï?? ï?? ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : A ï쳌µ ï쳌³ ï쳌´ ï쳌² ï쳌¡ ï쳌¬ ï쳌© ï쳌¡ Bioprospecting under the Act should only be granted general support for the recognition and preservation for the development and research of Western Australiaâ??s of indigenous peoples â?? native title and intellectual native biota . Furthermore , it should be clearly property rights . It was suggested that a framework and identified on licence agreements that a percentage mechanisms for negotiating benefit - sharing agreements of wealth generated from Bioprospecting should be between the State , corporations , academic institutions used for the protection , management and restoration and indigenous people should be undertaken as part of of WAâ??s biodiversity . Several submissions expressed the development of the Act . Difficulties and Successes Experienced During the Design of the Draft Regulations Compared to the lack of concrete progress during the pe - ownership in relation to ex situ collections posed some dif - riod from ï?? ï?? ï?? ï?? until ï?? ï?? ï?? ï?? , progress from the establishment ficulties for the holders of such collections and the Inquiry of Biotechnology Australia and the Inquiry in mid - ï?? ï?? ï?? ï?? sought legal advice on this issue . The following advice until the release of the draft regulations in September ï?? ï?? ï?? ï?? was part of a longer legal advice , which became Chapter was creditable . The Inquiry generated many responses , ï?? of V ï쳌¯ ï쳌µ ï쳌­ ï쳌¡ ï쳌² ï쳌¤ ( ï?? ï?? ï?? ï?? ) : which , in light of the relatively short public consultation The advice explains the legal status of the elements of the period , were reasonably comprehensive , generally relevant terrestrial and marine biota affected by differing forms to its terms of reference and compared well in terms of of land tenures and sovereignty in Commonwealth areas . quantity and quality to the submissions received by the The effect of the advice is that in all Commonwealth later House of Representatives committee on Primary in - areas , it is possible to determine either a legal owner dustries and Regional Services . The Inquiry also benefited of biological resources or a holder of the sovereign considerably from the varied knowledge and experience of authority to control access and derive benefits from the biological resources . its Chair and reference group members . The Inquiry report ( V ï쳌¯ ï쳌µ ï쳌­ ï쳌¡ ï쳌² ï쳌¤ ï?? ï?? ï?? ï?? ) was well received by key stakeholders It should be noted , since the question occasion - and other interested parties , but in some quarters there ally arose , that ownership under the common law is of was a lack of understanding , reflecting , perhaps , that the particular biological resources , that is , of the physical report was long and the issues it attempted to cover in a specimens themselves , not of the particular plants which fairly short period were many and complex . they represent or the species or genus to which they be - Indeed , the Inquiry and subsequent consultations iden - long . As a result , the Australian government â?? s ability , for tified many issues which had only been referred to briefly example , to sell samples of plants to a bioprospector for in previous work , for example , environmental issues as - biodiscovery purposes would not prevent it ( or any other sociated with bioprospecting ; indigenous knowledge and owner of the same plants ) from selling other samples of intellectual property issues ; and the need to harmonize a the same plants to another person ( unless it had agreed new access regime with existing schemes ( which were 52 with the first bioprospector not to do this ) . However , either based on other legislation or informal administra - the essential point is that neither a holder nor a buyer can tive arrangements ) at the Australian government level . claim ownership under the common law in the sense of Other issues had not been not raised at all , for example , exclusive rights to a particular plant or to the species or native title rights to biological resources . Where the short genus to which it belongs . The Inquiry report commented inquiry period prevented adequate consultations about on the need for stakeholders to understand the law regard - issues , the Inquiry report recommended , in general , that ing ownership of biological resources and stated explic - further research / consultations be undertaken ( V ï쳌¯ ï쳌µ ï쳌­ ï쳌¡ ï쳌² ï쳌¤ itly that it did not propose to make any recommendations ï?? ï?? ï?? ï?? ) . This was particularly the case in relation to the â?? that would affect the existing ownership arrangements â?쳌 harmonization of existing Australian government access 53 ( V ï쳌¯ ï쳌µ ï쳌­ ï쳌¡ ï쳌² ï쳌¤ ï?? ï?? ï?? ï?? ) . 50 arrangements . The proposal for accreditation ( although The Bailey report also considered the ownership is - the regulations do not use this term ) of access schemes , sue , commenting that the advice provided in the Inquiry reflected in the regulation which permits exemptions for report should be widely available : â?? It is important that the specified biological resources , also evolved during con - perception of uncertainty and complexity is dispelled as sultations following the release of the Voumard report be - far as possible as both are deterrents to making agreements tween the Department of the Environment and Heritage about bioprospecting , and investing in it and the indus - 51 and various Australian and State government agencies . tries derived from it â?쳌 ( B ï쳌¡ ï쳌© ï쳌¬ ï쳌¥ ï쳌¹ ï?? ï?? ï?? ï?? ) . The Bailey report observed further that â?? the lack of clarity about ownership Ownership of Biological Resources applies to areas under state and territory jurisdiction â?쳌 and that â?? legislative details vary from state to state â?쳌 , recom - V ï쳌¯ ï쳌µ ï쳌­ ï쳌¡ ï쳌² ï쳌¤ ( ï?? ï?? ï?? ï?? ) observed that â?? â?¦ debate about methods mending accordingly , that â?? Biotechnology Australia and of regulating access to biological resources has been com - the Attorney - Generalâ??s Department , in conjunction with plicated by a lack of understanding about who owns the resources in question . â?쳌 As we saw above , the question of the state and territory governments , ensure that information ï?? ï?? ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ about the ownership of biological resources is compiled , Benefit Sharing and made publicly available as a single , easily accessible The ï쳌¡ ï쳌© ï쳌­ ï쳌³ submission to the inquiry explained that the source â?쳌 ( B ï쳌¡ ï쳌© ï쳌¬ ï쳌¥ ï쳌¹ ï?? ï?? ï?? ï?? ) . lack of benefit - sharing arrangements had resulted in lost One issue that could , perhaps , benefit from clarifi - opportunities through stalled projects , sometimes after cation is that raised by the submission from the Center biodiscovery leads had been identified . The reluctance of of Indigenous History and the Arts to the inquiry into some marine resources - controlling agencies to grant per - Indigenous Cultural and Indigenous Property Rights and mits was â?? over concerns that adequate benefit sharing will 54 quoted in J ï쳌¡ ï쳌® ï쳌« ï쳌¥ ( ï?? ï?? ï?? ï?? ) to the effect that amendments not take place , should commercialization of a discovery to Western Australian legislation could effectively deprive occur . . . some agencies have attempted to . . . require some indigenous people of their potential intellectual property downstream benefit negotiations in the event of a com - rights and existing use rights ( see further , below , under mercial discovery . In other cases , access has been delayed , â?? Indigenous Issues â?쳌 ) . Similar comments were made by restricted , or denied . â?쳌 The Inquiry supported ï쳌¡ ï쳌© ï쳌­ ï쳌³ â?? recom - David Epworth , manager of the Caring for Country Unit mendation that benefit sharing be negotiated at the outset of of the Balkanu Aboriginal Development Corporation on a project , rather than after a lead had been identified , and Cape York with respect to the collecting arrangements reflected this in the proposed scheme ( V ï쳌¯ ï쳌µ ï쳌­ ï쳌¡ ï쳌² ï쳌¤ ï?? ï?? ï?? ï?? ) . between the Queensland Herbarium and AstraZeneca : Anecdotal evidence presented to the Access Taskforce â?? [ The Herbarium is ] actively accelerating their collection in consultations following the completion of the Inquiry program in order to exclude Aboriginal people . In that suggested that some agencies welcomed the establishment process theyâ??re advantaging pharmaceutical companies at of benefit - sharing mechanisms , particularly where public the expense of Aboriginal people . â?쳌 In response , however , moneys were being used to support research which could the manager of the Herbarium , Gordon Guymer , said that result ( and in one case , was known to have resulted ) in the Herbarium had done extensive vegetation mapping discoveries with commercial potential . on Cape York , but as far as he knew they had not been The Bailey report also addressed this issue : â?? One of collecting on any Aboriginal land . He said that if they the factors that has complicated and slowed the granting were going to do that they would certainly get in contact of access to biological resources has been uncertainty on 55 with the relevant people . In any case , the impact of leg - the part of those granting access permits about the benefits islation , policies and agreements on indigenous interests that should be required from bioprospectors , should com - may also be an issue for a nationally consistent scheme mercial discoveries result â?쳌 ( B ï쳌¡ ï쳌© ï쳌¬ ï쳌¥ ï쳌¹ ï?? ï?? ï?? ï?? ) . to address . Overblown expectations of benefits has also caused The legal advice also commented briefly on the owner - some agencies to delay the issue of permits . ï쳌¡ ï쳌© ï쳌­ ï쳌³ reported ship of intellectual property rights . Since this has been an to the Committee that in some cases delays had amounted important issue in debates over access and benefit sharing , to many years ( B ï쳌¡ ï쳌© ï쳌¬ ï쳌¥ ï쳌¹ ï?? ï?? ï?? ï?? ) . The Committee noted that particularly for indigenous people , the advice is quoted experience was now being gained in development of here in full : benefit - sharing contracts and that the Department of the Prime facie , the intellectual property rights in any Environment and Heritage was developing a model benefit - processes or products ( i.e . , patent rights ) derived sharing contract . Citing the Inquiry report , the Committee from ex situ collections of biological resources held explained the purposes of the model contract : to promote by Commonwealth agencies will belong to the person parties â?? understanding of the issues ; to facilitate negotia - responsible for developing [ them ] ( the inventor ) . tions and agreement between them ; and to provide cer - [ Patents Act ï?? ï?? ï?? ï?? ( Cth ) , s ï?? ï?? ( ï?? ) ( a ) ] . This is regardless tainty for industry by ensuring that agreements are based of the ownership of any resources from which [ they ] are on prior informed consent , mutually agreed terms , and derived , or where those resources may be held . However , adequate benefit - sharing arrangements , which will in turn it would be open to a Commonwealth agency to permit access only on the condition that intellectual property provide an agreed set of standards against which industryâ??s rights in any products derived from these resources are performance can be judged ( B ï쳌¡ ï쳌© ï쳌¬ ï쳌¥ ï쳌¹ ï?? ï?? ï?? ï?? ) . vested in a certain way , e.g . , jointly with the inventor , the Another issue which arose in the context of benefit Commonwealth , and a representative of the traditional sharing was the need to ensure that both the access scheme owners ( V ï쳌¯ ï쳌µ ï쳌­ ï쳌¡ ï쳌² ï쳌¤ ï?? ï?? ï?? ï?? ) . and the model contract are sufficiently flexible to allow Finally , it should be noted , since this is a controversial benefits to be negotiated appropriate to both commercial and complex issue at the international level , that several and noncommercial situations . The Inquiry report related submissions raised the issue that Australiaâ??s patent laws that many submissions , particularly those from research should not allow patenting of living organisms , whether organizations , commented on the importance of access 56 modified or not . As this issue was outside the Inquiryâ??s to biological research and of ensuring that an access sys - terms of reference , however , the Inquiry declined to ad - tem does not inhibit research . The Inquiry decided that , dress it ( V ï쳌¯ ï쳌µ ï쳌­ ï쳌¡ ï쳌² ï쳌¤ ï?? ï?? ï?? ï?? ) . in view of the fact that in many cases research will have unforeseen commercial implications or possibilities , this should be considered , as far as possible , at the outset of ï?? ï?? ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : A ï쳌µ ï쳌³ ï쳌´ ï쳌² ï쳌¡ ï쳌¬ ï쳌© ï쳌¡ negotiations and reflected in the contract . It recommended Government will recoup royalties of ï?? ï?? ï?? ï?? million ï쳌¡ ï쳌µ ï쳌¤ that â?? â?¦ terms in the proposed model contract anticipate per year by ï?? ï?? ï?? ï?? ( see section â?? Examples of Access and that most contracts will be for commercial purposes but Benefit - Sharing Agreements in Existing Bioprospecting that in some cases , terms which reflect noncommercially Projects â?쳌 for additional details about the smokebush agree - motivated research purposes may need to be drafted , and ment currently implemented by Cerylid ) . benefit sharing negotiated accordingly â?쳌 ( V ï쳌¯ ï쳌µ ï쳌­ ï쳌¡ ï쳌² ï쳌¤ ï?? ï?? ï?? ï?? ) . Intellectual property rights issues for indigenous peo - The Bailey report reflected these concerns in its recom - ples were put forward by a submission from the Center mendation that â?? when finalizing benefit - sharing arrange - of Indigenous History and the Arts ( University of Western ments , the Australian government ensure that commercial Australia ) that was quoted by Janke as follows : activity is not discouraged by the benefits bioprospectors â?? The current legislation disregards the potential are required to provide â?쳌 ( B ï쳌¡ ï쳌© ï쳌¬ ï쳌¥ ï쳌¹ ï?? ï?? ï?? ï?? ) . intellectual property rights that indigenous peoples in Western Australia have in flora on their lands . Indigenous Issues Furthermore , multinational drug companies could be sold exclusive rights to entire species of flora , preventing The terms of reference of ï쳌£ ï쳌³ ï쳌· ï쳌§ ( ï?? ï?? ï?? ï?? ) discussed above anyone from using those species for any other purpose included the obligation to take into account â?? the interests without the consent of the companies . Indigenous peoples of Aboriginal and Torres Strait Islander peoples in the use in WA now face the possibility of being prevented from using any of the flora which is the subject of an exclusive and ownership of traditional knowledge , innovations , and agreement . It is therefore vital that any reform of the practices and biological resources on Aboriginal lands â?쳌 . intellectual and cultural property laws include provisions However , ï쳌£ ï쳌³ ï쳌· ï쳌§ ( ï?? ï?? ï?? ï?? ) discussed the issue only briefly , for the recognition of Indigenous peoples as the native concluding that it was not within its terms of reference title owners of all the biological resources of the flora to resolve this complex matter , and suggesting that â?? it and fauna that are on their lands â?쳌 ( JANKE ï?? ï?? ï?? ï?? ) . was more appropriately dealt with in other fora , because Among the rights which indigenous people want in wider policy issues concerning the treatment of indigenous relation to their cultural and intellectual property , Janke peoples are involved , particularly in the context of recon - listed : â?? Control [ of ] disclosure , dissemination , reproduc - ciliation and social justice â?쳌 . tion , and recording of Indigenous knowledge , ideas , and The issue of the appropriation of indigenous biodiver - innovations concerning medicinal plants , biodiversity , and sity knowledge was raised in the report of the inquiry into environmental management â?쳌 ( J ï쳌¡ ï쳌® ï쳌« ï쳌¥ ï?? ï?? ï?? ï?? ) . Australian Indigenous Cultural and Intellectual Property The launch of Jankeâ??s report , Our Culture , Our Future Rights . which found that a major concern of indigenous ( J ï쳌¡ ï쳌® ï쳌« ï쳌¥ ï?? ï?? ï?? ï?? ) , in September ï?? ï?? ï?? ï?? coincided nicely with people was that â?? â?¦ their cultural knowledge of plants , the announcement of the Inquiry ( V ï쳌¯ ï쳌µ ï쳌­ ï쳌¡ ï쳌² ï쳌¤ ï?? ï?? ï?? ï?? ) three animals and the environment is being used by scientists , months earlier . The terms of reference of the Inquiry medical researchers , nutritionists and pharmaceutical com - stated that â?? The scheme should particularly focus on the panies for commercial gain , often without their informed equitable sharing of benefits arising from the utilization consent and without any benefits flowing back to them â?쳌 of traditional knowledge , innovations and practices â?쳌 ( J ï쳌¡ ï쳌® ï쳌« ï쳌¥ ï?? ï?? ï?? ï?? ) . Janke related the story of the smokebush , ( V ï쳌¯ ï쳌µ ï쳌­ ï쳌¡ ï쳌² ï쳌¤ ï?? ï?? ï?? ï?? ) . a plant which grows in certain coastal areas of Western The issue was very critical for the Inquiry because Australia and which has traditionally been used by indig - three of the Commonwealth areas under s ï?? ï?? ï?? of the ï쳌¥ ï쳌° ï쳌¢ ï쳌£ ï쳌¡ enous people of the region for healing . In the ï?? ï?? ï?? ï?? s , the are owned by indigenous people : Kakadu and Uluru - Kata Western Australian government granted the ï쳌µ ï쳌³ ï쳌¡ National Tjuta in the Northern Territory and Booderee on the south Cancer Institute ( ï쳌® ï쳌£ ï쳌© ) a license to collect plants for screen - coast of New South Wales . As national parks , they are sig - ing purposes . In the late ï?? ï?? ï?? ï?? s scientists at the ï쳌® ï쳌£ ï쳌© found nificant tourist destinations and could be expected to be of that the smokebush contained the active compound cono - interest to bioprospectors . They are leased to the Director curvone , which tests showed could destroy the ï쳌¡ ï쳌© ï쳌¤ ï쳌³ virus of National Parks and administered by the Department in low concentrations . This â?? discovery â?쳌 was subsequently of the Environment and Heritage . The ï쳌¥ ï쳌° ï쳌¢ ï쳌£ ï쳌¡ provides patented . The ï쳌® ï쳌£ ï쳌© awarded ï쳌¡ ï쳌­ ï쳌² ï쳌¡ ï쳌¤ Discovery Technologies 57 for joint management , by the Director and a Board of ( known today as Cerylid Biosciences ) an exclusive Management , of Commonwealth reserves that consist worldwide license to develop the patent . Under amend - of , or include , indigenous peopleâ??s land . A majority of ments to Western Australian environmental legislation , Board members must be indigenous people nominated by the Western Australian Minister of the Environment has the traditional Aboriginal owners if the reserve is wholly the power to grant exclusive rights to Western Australian 58 or mostly on indigenous peopleâ??s land . The Boards , in flora and fauna species for research purposes . In the early conjunction with the Director , are required to prepare ï?? ï?? ï?? ï?? s , the Western Australia Government also awarded 59 management plans for each of the parks . ï쳌¡ ï쳌­ ï쳌² ï쳌¡ ï쳌¤ the rights to the smokebush species , to develop The Inquiry report quoted sections from the manage - an anti - ï쳌¡ ï쳌© ï쳌¤ ï쳌³ drug . ï쳌¡ ï쳌­ ï쳌² ï쳌¡ ï쳌¤ paid ï?? ï?? . ï?? million ï쳌¡ ï쳌µ ï쳌¤ to secure ment plans for Kakadu and Uluru - Kata Tjuta on the rights access to smokebush and related species . If conocurvone is successfully commercialized , the Western Australia and roles of the traditional owners in managing biological ï?? ï?? ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ resources . The Kakadu plan includes sections indicating â?¢ The issue of protecting indigenous knowledge the importance of continuing traditional use and manage - should be considered further in ( but not necessar - ment of native plants and animals ; the need for the Boardâ??s ily limited to ) discussions towards developing a approval of applications for commercial activities in the nationally consistent system . park ; plans to develop a strategy for research in the park ; â?¢ ï쳌© ï쳌° A ï쳌µ ï쳌³ ï쳌´ ï쳌² ï쳌¡ ï쳌¬ ï쳌© ï쳌¡ should consider amending patent law and provisions regarding the collection of specimens in to require proof of source and , where appropriate , the park . The Uluru - Kata Tjuta plan specifically refers to prior informed consent , as a prerequisite for grant - bioprospecting and states that the owners have important 60 ing a patent . cultural and intellectual property rights that must be re - spected ( V ï쳌¯ ï쳌µ ï쳌­ ï쳌¡ ï쳌² ï쳌¤ ï?? ï?? ï?? ï?? ) . The Department of the Environment and Heritage In light of these issues , the Inquiry consulted with has continued its involvement in these issues , through its the park owners and their representatives ( in the case of participation in the Australian delegation to the second Kakadu , the Northern Land Council , and in the case of meeting of the ï쳌· ï쳌© ï쳌° ï쳌¯ Intergovernmental Committee on Uluru - Kata Tjuta , the Central Land Council ) , making two Intellectual Property and Genetic Resources , Traditional visits to each of the Northern Territory parks and one to Knowledge and Folklore , held in Geneva in December Booderee . The Inquiry carefully considered submissions ï?? ï?? ï?? ï?? and its contributions to briefs for meetings of the from the owners of Kakadu ( prepared in conjunction with Committee . The Department has also funded several the Northern Land Council ) and the Central Land Council , projects on indigenous knowledge including one by the reflecting both in some detail in the report , as well as sug - Nepabunna Community in SouthAustralia , and one by the gestions for a scheme under s ï?? ï?? ï?? of the ï쳌¥ ï쳌° ï쳌¢ ï쳌£ ï쳌¡ from other Kuku Yalanji People Community and the Balkanu Cape interested individuals and organizations . In addition , the York Development Corporation in Far North Queensland , Inquiry reflected its awareness of the importance of con - and organized a workshop on indigenous knowledge in tinuing consultations , recommending , among other things , Canberra in February ï?? ï?? ï?? ï?? , to consider the further imple - 61 that the Department of the Environment and Heritage â?? en - mentation of Article ï?? ( j ) of the ï쳌£ ï쳌¢ ï쳌¤ . sure that traditional owners and their representatives are The Bailey Committee also addressed the issue of further consulted on , and given adequate opportunities to indigenous rights , commenting that â?? There are two ele - contribute to , development of regulations under s ï?? ï?? ï?? of ments to Indigenous involvement in bioprospecting : one the ï쳌¥ ï쳌° ï쳌¢ ï쳌£ ï쳌¡ â?쳌 ( V ï쳌¯ ï쳌µ ï쳌­ ï쳌¡ ï쳌² ï쳌¤ ï?? ï?? ï?? ï?? ) . is the result of indigenous ownership of the land and the Many submissions expressed concern about the use other comes from knowledge of the uses to which na - of indigenous knowledge without consultation , prior tive plants and animals can be put â?쳌 ( B ï쳌¡ ï쳌© ï쳌¬ ï쳌¥ ï쳌¹ ï?? ï?? ï?? ï?? ) . With informed consent , or benefit sharing . These views went respect to ownership , the Committee noted that in some beyond the issue of protecting the rights of the traditional parts ofAustralia significant areas are owned byAboriginal owners of the parks in the context of the s ï?? ï?? ï?? regulations groups ( ï?? ï?? % of the Northern Territory and ï?? ï?? % of South ( which could be achieved through the access and ben - Australia ) and referred to the recommendations of the efit - sharing arrangements recommended by the Inquiry ) Inquiry report regarding prior informed consent , mutually and were , in that respect , beyond the Inquiryâ??s terms of agreed terms , and adequate benefit sharing that protects reference . Nevertheless , in the knowledge that these are and values traditional knowledge , as well as to recom - significant and sensitive issues for indigenous people , the mendations that decisions by indigenous communities to Inquiry report summarized them , concluding that â?? in view deny access to bioprospectors should not be reviewable ; of the complexity of these issues , their extension beyond and that advice be provided to indigenous communities Commonwealth â?? areas â?쳌 under the ï쳌¥ ï쳌° ï쳌¢ ï쳌£ ï쳌¡ , and the fact that on how to get the best deals possible with bioprospectors discussion about them is relatively recent in the Australian ( B ï쳌¡ ï쳌© ï쳌¬ ï쳌¥ ï쳌¹ ï?? ï?? ï?? ï?? ) . context , the Inquiry believes that further research , consulta - With respect to traditional knowledge , the Committee tions with stakeholders , and community education are de - stated that â?? There has been some criticism and dispute sirable â?쳌 . V ï쳌¯ ï쳌µ ï쳌­ ï쳌¡ ï쳌² ï쳌¤ ( ï?? ï?? ï?? ï?? ) made four recommendations : in the past about the unacknowledged use of traditional â?¢ The Department of the Environment and Heritage knowledge in Australia , â?쳌 and included the example of should monitor international research and debate the Western Australian smokebush ( B ï쳌¡ ï쳌© ï쳌¬ ï쳌¥ ï쳌¹ ï?? ï?? ï?? ï?? ) . The by the World Intellectual Property Organization Committee then cited , as an example of continuing ( ï쳌· ï쳌© ï쳌° ï쳌¯ ) , the World Trade Organization ( ï쳌· ï쳌´ ï쳌¯ ) , and criticism , the submission of the Royal Society of Western other fora on protection of indigenous knowledge , Australia relating to the contract between the Western as well as debate and research on the issue in Australia government and a company , BioProspect , Australia . which the Society claimed appeared not to allow for the recognition of indigenous knowledge . The Committee â?¢ In the event that stronger measures to protect in - commented , however , that a national trust fund , such as digenous knowledge are introduced internationally that BioProspect proposed in its submission , would ad - or in Australia , the Department should consider dress this problem , adding that BioProspect does not rely the adequacy of the regulations in protecting indig - enous intellectual property rights . on traditional knowledge to guide its bioprospecting , but ï?? ï?? ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : A ï쳌µ ï쳌³ ï쳌´ ï쳌² ï쳌¡ ï쳌¬ ï쳌© ï쳌¡ prefers to use high throughput screening which is more well considered . They fail to recognize that the â?¦ Act rep - effective in discovering bioactive materials than using resents worldâ??s best practice through its basic principles , traditional knowledge ( B ï쳌¡ ï쳌© ï쳌¬ ï쳌¥ ï쳌¹ ï?? ï?? ï?? ï?? ) . that the scope of the Act is limited , that it coexists with The Inquiry report also commented that the Inquiryâ??s other legislation and that the exercise of [ plant breeders â?? ] 63 informal discussions with industry suggest that indigenous rights is regulated by such legislation . â?쳌 The issue does knowledge is not widely used as a source of information remain a live one , however , particularly in Queensland , about the potential uses of plants . V ï쳌¯ ï쳌µ ï쳌­ ï쳌¡ ï쳌² ï쳌¤ ( ï?? ï?? ï?? ï?? ) stated as evidenced by a radio program in which various people , that : including the Executive Director of the Balkanu CapeYork Development Corporation , Gerhardt Pearson , continued to One explanation offered for this was that , in the absence express concern about the lack of opportunities for indig - of clear and fair rules , companies were generally enous people to gain from benefit - sharing agreements and reluctant to pursue the application of indigenous the lack of recognition by the government of the rights of knowledge to biodiscovery . Companies were concerned indigenous people to biological resources and traditional that irrespective of the good faith agreements they might 64 make with indigenous groups , they might be vulnerable knowledge . Their concerns have not , it appears , been to criticism about the adequacy of the agreement unless allayed by the Q ï쳌µ ï쳌¥ ï쳌¥ ï쳌® ï쳌³ ï쳌¬ ï쳌¡ ï쳌® ï쳌¤ G ï쳌¯ ï쳌¶ ï쳌¥ ï쳌² ï쳌® ï쳌­ ï쳌¥ ï쳌® ï쳌´ ( ï?? ï?? ï?? ï?? ) , which there were independent standards against which they stated that the Government would ensure that the develop - could be judged . The Inquiry also heard comments ment of biodiscovery policy in Queensland â?? engages local that , increasingly , the focus of biodiscovery is on indigenous communities , relevant community organiza - microorganisms which industry believes did not play a tions , and Native Title Representative Bodies to identify role in indigenous culture . â?쳌 methods to address and respect traditional knowledge of Indeed , it is not clear from accounts of the smokebush Queensland biological resources where such knowledge issue whether indigenous knowledge was actually used is used for biodiscovery â?쳌 . It should be noted that Principle to identify the potential healing properties of the plant or ï?? of the Nationally Consistent Approach is that legisla - whether this was only revealed through screening . tive , administrative , or policy frameworks in Australian With respect to intellectual property issues , the Bailey jurisdictions shall â?? Recognize the need to ensure the use Committee acknowledged that Australiaâ??s intellectual of traditional knowledge is undertaken with the coopera - property regime does not currently protect traditional tion and approval of the holders of that knowledge and on knowledge , noted some of the difficulties in doing this , mutually agreed terms â?쳌 ( ï쳌® ï쳌² ï쳌­ ï쳌­ ï쳌£ ï?? ï?? ï?? ï?? ) . and commented that : â?? What may therefore be needed is a This may be a narrower principle than that which in - new category of rights that protects traditional knowledge digenous people appear to be asserting . The fact that the from unauthorized use , recognizes its origin , and provides debate continues , however , suggests that there may be a just compensation . Sui generis methods of intellectual need for a more rigorous attempt to identify and clarify property protection , such as those used for plant varieties , the issues and to develop acceptable solutions . have been recommended in this context â?쳌 ( B ï쳌¡ ï쳌© ï쳌¬ ï쳌¥ ï쳌¹ ï?? ï?? ï?? ï?? ) . The Committee noted recent developments ( particularly Exclusivity the work of ï쳌· ï쳌© ï쳌° ï쳌¯ â?? s Intergovernmental Committee on Another issue which the Committee noted as being of par - Intellectual Property ) and concluded ( without making a ticular concern in submissions to its inquiry was the ques - specific recommendation ) that it â?? â?¦ supports ï쳌© ï쳌° ï쳌¡ â?? s work tion of exclusivity . We have seen , above , concerns quoted in promoting the use of existing intellectual property pro - in J ï쳌¡ ï쳌® ï쳌« ï쳌¥ ( ï?? ï?? ï?? ï?? ) about the impact of exclusive rights on tection among Australiaâ??s indigenous people and assisting the intellectual property rights of indigenous people and ï쳌· ï쳌© ï쳌° ï쳌¯ â?? s efforts to provide a more comprehensive system for on access for other purposes , including traditional uses . protecting traditional knowledge â?쳌 ( B ï쳌¡ ï쳌© ï쳌¬ ï쳌¥ ï쳌¹ ï?? ï?? ï?? ï?? ) . The Inquiry report did not address this issue in detail , but In October ï?? ï?? ï?? ï?? , the Australian Senate considered did note similar concerns expressed by the Queensland amendments to the Plant Breederâ??s Rights Act ï?? ï?? ï?? ï?? , in - Government and by indigenous people ( V ï쳌¯ ï쳌µ ï쳌­ ï쳌¡ ï쳌² ï쳌¤ ï?? ï?? ï?? ï?? ) . cluding proposed amendments by Senator John Cherry , It noted that the parties to the contract are free to negotiate a member of the Australian Democrats , a minority â?? exclusivity â?쳌 terms in whatever manner they wish and that Opposition party in the Senate . Addressing the Senate on a range of terms is possible . The Inquiry decided that it ï?? ï?? October ï?? ï?? ï?? ï?? , Senator Cherry explained the purpose was not necessary to make any recommendations on this of the amendments as being to â?? â?¦ reduce the chances of matter , as the proposed scheme would require the Minister , biopiracy from Indigenous land and increase the capacity in deciding whether to grant or refuse a permit , to con - of the Indigenous community to object when biopiracy is 62 sider the fairness of â?? exclusivity â?쳌 clauses in the contract , occurring â?쳌 . among other issues , against the indicia of proper informed However , the amendments did not have Government consent , mutually agreed terms , and adequate benefit shar - support . The Parliamentary Secretary to the Minister for ing . The report did suggest , however , that terms of a more Agriculture , Fisheries , and Forestry , Senator Judith Troeth , â?? exclusive â?쳌 nature which benefit the bioprospector should explained that â?? The amendments â?¦ are not the subject matter of the bill . In addition , they are not particularly be reflected in the nature and / or amount of benefits payable ï?? ï?? ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ to the resource provider ( V ï쳌¯ ï쳌µ ï쳌­ ï쳌¡ ï쳌² ï쳌¤ ï?? ï?? ï?? ï?? ) . registered under s ï?? ï?? ï?? A of the ï쳌¥ ï쳌° ï쳌¢ ï쳌£ ï쳌¡ must be invited to make written submissions about whether a permit should Concerns which the Bailey report discussed included be issued ( on environmental grounds ) and that these ensuring that arrangements made with commercial op - should be taken into account by the Minister in making erators do not restrict noncommercial activities and do his decision ; the â?? precautionary principle â?쳌 must be applied , allow reasonable access to other commercial operators . â?? where appropriate â?쳌 ; any variations to the model contract The Committee noted the concerns of some operators , must be â?? acceptable â?쳌 ; a maximum of three years would both commercial and noncommercial , that this type of be set for the validity of an access permit ; and the permit restriction might ( or indeed does ) occur , and commented may be transferred only with the approval of the Minister that â?? â?¦ care must be taken when setting the permit con - ( B ï쳌¡ ï쳌© ï쳌¬ ï쳌¥ ï쳌¹ ï?? ï?? ï?? ï?? ) . ditions and making benefit arrangements to ensure that The key elements of the scheme which ï쳌¤ ï쳌¡ ï쳌¦ ï쳌¦ preferred reasonable opportunities are available to all wishing to were : a model material transfer agreement ( ï쳌­ ï쳌´ ï쳌¡ ) for access access a particular area â?쳌 ( B ï쳌¡ ï쳌© ï쳌¬ ï쳌¥ ï쳌¹ ï?? ï?? ï?? ï?? ) . to in situ material ( and ex situ material in some cases ) under The Committee recommended that when granting ac - Australian government ownership and control ; inclusion cess , the Australian Government ensure access for non - in the ï쳌­ ï쳌´ ï쳌¡ of a flexible benefit - sharing agreement contin - commercial activities and , with commercial activities , gent on the material being commercialized ( for example , ensure a balance between open competitive access and a percentage of the gross profits over the last five years of restricting access by granting exclusive use . Exclusivity commercialization ) ; exemptions for benefit sharing consid - should be restricted by permit conditions such as dura - ered if the recipient company or institution is prepared to tion , area or species collected , and uses to be explored make the developed material publicly available for further ( B ï쳌¡ ï쳌© ï쳌¬ ï쳌¥ ï쳌¹ ï?? ï?? ï?? ï?? ) . research ; access to , and benefit sharing of , biological re - sources on freehold property subject to private negotiation Criticism of the Proposed Scheme ( although the model ï쳌­ ï쳌´ ï쳌¡ for Commonwealth areas may The Bailey report is a useful source of evidence of criti - serve as a model for the private sector ) ; and encouragement cisms which were made of the proposed access scheme , extended to States and Territories to adopt the Australian some of which were variously made in response to the government approach as a basis to achieve a nationally Inquiry report , the drafting instructions for the regulations , consistent framework ( B ï쳌¡ ï쳌© ï쳌¬ ï쳌¥ ï쳌¹ ï?? ï?? ï?? ï?? ) . ï쳌¤ ï쳌¡ ï쳌¦ ï쳌¦ also stressed and the draft regulations themselves . In particular , the the need for a detailed regulatory impact statement examin - Committee discussed criticisms of the proposed scheme ing the practical impact of any regulations on government , by the Department of Agriculture , Fisheries and Forestry business , and other users ( B ï쳌¡ ï쳌© ï쳌¬ ï쳌¥ ï쳌¹ ï?? ï?? ï?? ï?? ) . The Bailey report ( ï쳌¤ ï쳌¡ ï쳌¦ ï쳌¦ ) . ï쳌¤ ï쳌¡ ï쳌¦ ï쳌¦ expressed the following concerns : first , that noted some of the responses of the Department of the the proposed regime might alter existing property rights Environment and Heritage to ï쳌¤ ï쳌¡ ï쳌¦ ï쳌¦ â?? s points . In hearings and interfere with intellectual property rights ( or at least before the Committee , the Department disputed that the give that appearance ) ; second , that it might jeopardize scheme of the Inquiry report would replace the common Australiaâ??s ability to access genetic material from overseas law with new property rights or interfere with intellectual for crop improvement ; and , third , that it was too onerous property protection . The Department also stressed that ( B ï쳌¡ ï쳌© ï쳌¬ ï쳌¥ ï쳌¹ ï?? ï?? ï?? ï?? ) . the proposed benefit - sharing arrangements would allow With respect to the second point , ï쳌¤ ï쳌¡ ï쳌¦ ï쳌¦ claimed that for considerable flexibility in what should be included in â?? â?¦ while such international developments [ the revision contracts ( B ï쳌¡ ï쳌© ï쳌¬ ï쳌¥ ï쳌¹ ï?? ï?? ï?? ï?? ) . of the ï쳌¦ ï쳌¡ ï쳌¯ International Undertaking on Plant Genetic The Committee also noted that , with respect to the Resources ] do not preclude the application of an access and need to accommodate existing international obligations benefit - sharing system in Australia , the need to reconcile such as the International Undertaking on Plant Genetic any domestic system with such international developments Resources , the Inquiry report had recommended that mate - is highly important to avoid having two systems of access rial which is the subject of such agreements be excluded and benefit - sharing operating inAustralia â?쳌 ( B ï쳌¡ ï쳌© ï쳌¬ ï쳌¥ ï쳌¹ ï?? ï?? ï?? ï?? ) . from the regulations . ï쳌¤ ï쳌¡ ï쳌¦ ï쳌¦ , however , took the view that this Furthermore , ï쳌¤ ï쳌¡ ï쳌¦ ï쳌¦ related that Australia is a â?? significant approach would introduce complexity because it would net beneficiary â?쳌 from the current and likely future multi - establish â?? multiple systems covering different biological lateral system for the exchange of plant genetic resources , material â?쳌 ( B ï쳌¡ ï쳌© ï쳌¬ ï쳌¥ ï쳌¹ ï?? ï?? ï?? ï?? ) . and further stated that : â?? If Australia were to charge for The Committee did not discuss these issues further access to public biological material we would not be but , in relation to them , recommended that in finalizing surprised if other countries were to do the same to us â?쳌 the regulations , the Australian government should ensure ( B ï쳌¡ ï쳌© ï쳌¬ ï쳌¥ ï쳌¹ ï?? ï?? ï?? ï?? ) . that the regulations did not create new property rights ; 65 With respect to its third point , ï쳌¤ ï쳌¡ ï쳌¦ ï쳌¦ listed the fol - should obtain a detailed regulatory impact statement ; and lowing as â?? elements of the Voumard recommendations should examine fully the implications of the regulations that if adopted could prove onerous and a disincentive for Australiaâ??s access to overseas plant genetic material to commercial bioprospecting â?쳌 : every interested person ( B ï쳌¡ ï쳌© ï쳌¬ ï쳌¥ ï쳌¹ ï?? ï?? ï?? ï?? ) . ï?? ï?? ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : A ï쳌µ ï쳌³ ï쳌´ ï쳌² ï쳌¡ ï쳌¬ ï쳌© ï쳌¡ Bioprospecting Initiatives There is already a history of bioprospecting companies ne - emerges and ï쳌¡ ï쳌© ï쳌­ ï쳌³ derives net royalty income , ï쳌¡ ï쳌© ï쳌­ ï쳌³ shall gotiating with government agencies and other institutions pay ï?? . ï?? % of the net royalty income to the state ) , but other for access to biological resources and agreeing to provide benefits focus on research and biotechnology development 68 benefits . Some major examples of these agreements are opportunities , particularly in Queensland . 66 outlined below . It would seem unlikely that major bio - Cerylid prospectors would have any difficulties in operating within Cerylid has entered into plant collecting contracts with the terms of theAustralian government regulations , in light a wide range of collectors : the Royal Botanic Gardens of their experience in dealing with legislative and / or con - in Melbourne , Victoria , and the Victorian Department of tractual requirements in other jurisdictions . Conservation and Natural Resources ; the Parks andWildlife Under the draft regulations , the cost of a permit is Commission of the Northern Territory ; the Arnhem Land notional and the same for all applicants ( national or in - Aboriginal Land Trust and the Northern Land Council ; ternational , research or commercial ) : ï?? ï?? ï?? ï쳌¡ ï쳌µ ï쳌¤ for access the TiwiAboriginal Land Trust ; the Tasmanian Herbarium and no payment for a transfer of the permit or variation through the Trustees of the Tasmanian Museum ; the 67 or revocation of a permit condition . This fee would not Government of the State of Sarawak ( Malaysia ) ; the even cover administration costs . Benefits , of course , are Kelam People of the Kaironk Valley in Papua New to be negotiated on a case - by - case basis . Guinea , through the Australian National University ; and the Tillegerry Habitat Association , New South Wales . Examples of Access and Benefit - Sharing Agreements relating to microorganisms have been made Agreements in Existing Bioprospecting with the Antarctic Cooperative Research Center ; the Projects Department of Ecology and Biodiversity at the University of Hong Kong ; theAustralian Tropical Mycology Research AstraZeneca R & D Griffith University Center ; Flinders University , South Australia ; and Biotech AstraZeneca R & D Griffith University has contracts with International Limited.Agreements relating to microorgan - the Queensland Museum and the Queensland Herbarium isms and macroorganisms were made with the Australian under which the Museum and the Herbarium collect Institute of Marine Science ( V ï쳌¯ ï쳌µ ï쳌­ ï쳌¡ ï쳌² ï쳌¤ ï?? ï?? ï?? ï?? ) . specimens for AstraZenecaâ??s R & D facility located at Cerylid observes the following principles in its plant Griffith University in Brisbane , Queensland . Key terms collecting arrangements : agreements are enacted with of these contracts include : payments to the collectors for relevant government and indigenous authorities ; agree - the samples and a percentage of proceeds from commercial ments provide for sample / species collection ; samples are exploitation of compounds obtained from them ; agreement collected by local botanical authorities ; voucher specimens by the collectors to keep confidential certain matters relat - are maintained by local herbaria ; agreements are long term ing to samples and supply , while ensuring that essential and exclusive to the company ; intellectual property rights taxonomic information is placed in a public collection ; and are owned by or assigned to the company ; and benefits , the Universityâ??s exclusive right to the collectors â?? services either commercial ( payments for samples , royalties ) or ( V ï쳌¯ ï쳌µ ï쳌­ ï쳌¡ ï쳌² ï쳌¤ ï?? ï?? ï?? ï?? ) . noncommercial ( such as training ) , are provided to the custodians ( V ï쳌¯ ï쳌µ ï쳌­ ï쳌¡ ï쳌² ï쳌¤ ï?? ï?? ï?? ï?? ) . Issues relating to the smoke - Australian Institute of Marine Science bush project and agreement were presented earlier in the The Australian government established ï쳌¡ ï쳌© ï쳌­ ï쳌³ in ï?? ï?? ï?? ï?? to section â?? Indigenous Issues . â?쳌 Additional details about the generate the knowledge needed for the sustainable use and agreement are presented by ï쳌´ ï쳌¥ ï쳌® K ï쳌¡ ï쳌´ ï쳌¥ and L ï쳌¡ ï쳌© ï쳌² ï쳌¤ ( ï?? ï?? ï?? ï?? ) protection of the marine environment through scientific as follows : In ï?? ï?? ï?? ï?? a ï쳌µ ï쳌³ ï쳌¡ botanist collected around ï?? , ï?? ï?? ï?? and technological research . For over a decade ï쳌¡ ï쳌© ï쳌­ ï쳌³ â?? ac - plant specimens in WesternAustralia which were then sent tivities have included bioprospecting research . The center - to the ï쳌µ ï쳌³ ï쳌¡ National Institutes of Health for screening . In piece of this research is the marine biodiversity collection the late ï?? ï?? ï?? ï?? s , a species of smokebush showed promising which includes material from more than ï?? ï?? , ï?? ï?? ï?? marine activity in anti - cancer screens . The Institute obtained a macro - organisms and ï?? , ï?? ï?? ï?? marine microorganisms col - patent on the active compound of the smokebush . At the lected from over ï?? , ï?? ï?? ï?? sites around Australia ( V ï쳌¯ ï쳌µ ï쳌­ ï쳌¡ ï쳌² ï쳌¤ same time , research by scientists in Western Australia also ï?? ï?? ï?? ï?? ) . ï쳌¡ ï쳌© ï쳌­ ï쳌³ has had contracts with organizations such as revealed the potential anti - ï쳌¨ ï쳌© ï쳌¶ activity of the smokebush . the ï쳌® ï쳌£ ï쳌© and Cerylid . To ensure that the development and production of any po - ï쳌¡ ï쳌© ï쳌­ ï쳌³ â?? contract with the Queensland government tential drug be based and coordinated in WesternAustralia , ( signed in July ï?? ï?? ï?? ï?? ) is the only Australian benefit - shar - the Department of Conservation and Land Management ing arrangement whose text has been made public ( see ( ï쳌£ ï쳌¡ ï쳌¬ ï쳌­ ) entered into an agreement with the company under Box ï?? ) . The context in which it was negotiated was the which it was granted access to the smokebush and permis - Queensland governmentâ??s interest in promoting the bio - sion to develop it commercially . The company agreed to technology industry in that state . The contract includes agreement regarding the payment of royalties ( if a lead provide to ï쳌£ ï쳌¡ ï쳌¬ ï쳌­ ï?? ï?? ï?? ï?? , ï?? ï?? ï?? ï쳌µ ï쳌³ ï쳌¤ , a share in royalties , and the ï?? ï?? ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ right of first refusal to conduct any research on the active BioProspect compound . The company also provided ï?? ï?? ï?? ï?? , ï?? ï?? ï?? ï쳌µ ï쳌³ ï쳌¤ for BioProspect , a listed Australian company , was established further research by a consortium of Western Australian in ï?? ï?? ï?? ï?? in Western Australia . The company negotiates ac - scientists , in collaboration with the ï쳌® ï쳌£ ï쳌© , on some eight cess to biological resources for the purpose of drug dis - smokebush patents lodged by ï쳌£ ï쳌¡ ï쳌¬ ï쳌­ . Benefit sharing took covery , screens plant extracts for a range of therapeutic two forms : research funding ( covering joint research and activities in their laboratory in Perth , Western Australia , technology acquisition ) and a share in royalties . The sci - and supplies drug discovery companies with samples entists received ï?? ï?? ï?? ï?? , ï?? ï?? ï?? ï쳌µ ï쳌³ ï쳌¤ to cover research conducted for further testing . In late ï?? ï?? ï?? ï?? , Western Australiaâ??s then prior to the agreement that had led to several Western Environment Minister announced the â?? commencement of Australia patents on conocurvone . Over the year following the largest scientific research for new medicines derived the agreement , they received an additional ï?? ï?? ï?? ï?? , ï?? ï?? ï?? ï쳌µ ï쳌³ ï쳌¤ from WesternAustralian flora yet undertaken inAustralia â?쳌 . for further research . Government and university laborato - Under this agreement , ï쳌£ ï쳌¡ ï쳌¬ ï쳌­ would collect plant samples ries of consortium members were equipped with various from Crown ( government - owned ) land for BioProspect technologies . ï쳌£ ï쳌¡ ï쳌¬ ï쳌­ used the remaining funds to establish under a license agreement . The company would pay a fee the Western Australia Biotic Extract Library , a library of for each sample provided , as well as a percentage of all biotic extracts for drug discovery . revenue earned from other companies seeking access to the Box 1 . Summary of the Biotechnology Benefit - Sharing Agreement between AIMS and the State of Queensland ( QLD ) Recitals Access Arrangements â?¢ ï쳌¡ ï쳌© ï쳌­ ï쳌³ â?? marine research activities include biodiscovery ( or â?¢ ï쳌¡ ï쳌© ï쳌­ ï쳌³ has exclusive right to access ï쳌± ï쳌¬ ï쳌¤ samples for its bioprospecting ) research whose goals include to discover research ( this does not extend to the species that are rep - biologically active molecules that can be developed as resented by the ï쳌± ï쳌¬ ï쳌¤ samples ) . useful products by and with industry collaborators . â?¢ ï쳌¡ ï쳌© ï쳌­ ï쳌³ may collect new ï쳌± ï쳌¬ ï쳌¤ samples for the purpose of bio - â?¢ ï쳌¡ ï쳌© ï쳌­ ï쳌³ â?? research has the potential to deliver benefits ( both discovery research , subject to any requirements to obtain monetary and non - monetary ) to ï쳌± ï쳌¬ ï쳌¤ . permission from the appropriate ï쳌± ï쳌¬ ï쳌¤ government agency . â?¢ When ï쳌¡ ï쳌© ï쳌­ ï쳌³ receives benefits , it seeks to equitably share â?¢ ï쳌¡ ï쳌© ï쳌­ ï쳌³ has the exclusive right to supply biodiscovery re - those benefits with the resource owners . search samples that are ï쳌± ï쳌¬ ï쳌¤ samples to third parties for biodiscovery research in which ï쳌¡ ï쳌© ï쳌­ ï쳌³ is a collaborator â?¢ ï쳌± ï쳌¬ ï쳌¤ is interested in facilitating ecologically sustainable ( third parties may include industrial and / or commercial access to and use of its biological resources for biodiscov - collaborators in Australia or overseas ) . ery purposes ; utilizing its biodiversity to facilitate incre - mental capacity building and value adding in the Stateâ??s â?¢ If ï쳌¡ ï쳌© ï쳌­ ï쳌³ provides ï쳌± ï쳌¬ ï쳌¤ samples to third parties , ï쳌¡ ï쳌© ï쳌­ ï쳌³ must biotechnology industries ; and capturing an equitable share ensure that under the third party agreement it is acknowl - of the benefits derived from the use of ï쳌± ï쳌¬ ï쳌¤ â?? s resources for edged that the State is the owner of the resource from biodiscovery purposes . which the ï쳌± ï쳌¬ ï쳌¤ samples were derived . â?¢ Under a biotechnology benefit - sharing arrangement with Purpose and scope of the agreement ï쳌± ï쳌¬ ï쳌¤ , ï쳌¡ ï쳌© ï쳌­ ï쳌³ has the right to access and conduct scientific â?¢ The purpose of the agreement is to set the framework research on the samples . within which ï쳌¡ ï쳌© ï쳌­ ï쳌³ and ï쳌± ï쳌¬ ï쳌¤ fairly share in the benefits of â?¢ Before attempting to negotiate collaborative agreements biodiscovery research using ï쳌± ï쳌¬ ï쳌¤ samples . with third parties outside Australia , ï쳌¡ ï쳌© ï쳌­ ï쳌³ must use all â?¢ ï쳌± ï쳌¬ ï쳌¤ samples are samples obtained from coastal areas de - reasonable endeavors to satisfy the following criteria : termined by the Seas and Submerged Lands Act of ï?? ï?? ï?? ï?? â?? Similar collaborative opportunities are not available on and the Coastal Water ( State Titles ) Act of ï?? ï?? ï?? ï?? . reasonable terms , first , in ï쳌± ï쳌¬ ï쳌¤ and second , elsewhere Duration in Australia . â?¢ The agreement commences on the date of the agreement â?? The option of transferring the technology from over - and continues until terminated by one or both parties seas , first , to ï쳌± ï쳌¬ ï쳌¤ and second elsewhere in Australia , pursuant to the terms of the agreement . to eliminate the need to send ï쳌± ï쳌¬ ï쳌¤ samples overseas is not possible on reasonable terms . Review â?? The quantity of material sent overseas is restricted to â?¢ The agreement is subject to review by both parties after the minimum required for pre - agreed work and the it has been in operation for one year and every two years overseas collaborator is required to return any unused hereafter , at which time amendments can be negotiated material . by the parties . â?? Data accompanying the material sent overseas will be â?¢ After ï?? years , the operations of ï쳌¡ ï쳌© ï쳌­ ï쳌³ biodiscovery research limited to data reasonably required by the overseas will be independently reviewed ( ï쳌± ï쳌¬ ï쳌¤ to choose reviewer , collaborator to achieve the agreed objectives of the cover costs , and keep information commercial in confi - dence ; ï쳌¡ ï쳌© ï쳌­ ï쳌³ will have access to all information ) . collaboration . ï?? ï?? ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : A ï쳌µ ï쳌³ ï쳌´ ï쳌² ï쳌¡ ï쳌¬ ï쳌© ï쳌¡ samples , and a royalty on the sale of the products derived BioProspect has identified the following as key ele - from the samples . Funds received would be used to boost ments of its contracts : access is on the basis of sustain - able access ; primary ownership of all intellectual property flora conservation and research . The agreement would not derived from a biological resource remains in the hands of prevent others from applying for permits to collect plants , the state ( Western Australia ) ; the state receives royalties including those wanting to pick wildflowers commercially , from any commercial activity resulting or derived from academics wanting to further their research , andAboriginal its biological resources ; and whenever possible , the in - people wanting to use plants for medicinal purposes . The frastructure and human resources of the state are used to company planned to invest about ï?? ï?? ï?? million ï쳌¡ ï쳌µ ï쳌¤ over collect , process , and add value to the primary biological the next five years to equip its screening facilities and to 69 resource ( V ï쳌¯ ï쳌µ ï쳌­ ï쳌¡ ï쳌² ï쳌¤ ï?? ï?? ï?? ï?? ) . employ scientific and administrative staff . Biodiversity Conservation , Sustainable Use , and Benefit - Sharing Strategies As required by its terms of reference , the Inquiry report need for a â?? precautionary â?쳌 approach ( V ï쳌¯ ï쳌µ ï쳌­ ï쳌¡ ï쳌² ï쳌¤ ï?? ï?? ï?? ï?? ) . addressed environmental issues at some length . Many sub - Possible environmental impacts of bioprospecting missions to the Inquiry emphasized the need for environ - were considered by both the Queensland government mental assessment to be undertaken before bioprospecting and ï쳌¡ ï쳌© ï쳌­ ï쳌³ which , as related above , have entered into a activities could be approved , although only a few presented major bioprospecting contract ( Box ï?? ) . The Queensland specific evidence about the possible adverse environmen - governmentâ??s submission said that : tal impacts of bioprospecting ( V ï쳌¯ ï쳌µ ï쳌­ ï쳌¡ ï쳌² ï쳌¤ ï?? ï?? ï?? ï?? ) . However , â?¦ most primary biodiscovery collections involve reflecting the current lack of knowledge about much of relatively small samples sizes of less than ï?? ï?? ï?? grams Australiaâ??s biodiversity ( marine invertebrate fauna were per species and , provided the target species are readily cited as a specific example ) , submissions advocated the available with a sustainable population in the target area , Box 1 . Continued with the ï쳌± ï쳌¬ ï쳌¤ Museum with collection data and any other â?¢ ï쳌¡ ï쳌© ï쳌­ ï쳌³ agrees to use reasonable endeavors to ensure any information that may contribute to furthering the Stateâ??s commercial arrangement with a third party complies with scientific knowledge . the following criteria : â?¢ ï쳌¡ ï쳌© ï쳌­ ï쳌³ shall use its best endeavors to collaborate with the â?? Opportunities for intellectual property development ï쳌± ï쳌¬ ï쳌¤ Museum regarding the coordination and lodgment of are maximized , first , in ï쳌± ï쳌¬ ï쳌¤ and second , elsewhere in preserved voucher specimens . Australia . â?¢ ï쳌¡ ï쳌© ï쳌­ ï쳌³ shall use its best endeavors to collaborate with â?? Opportunities are captured , first , for ï쳌± ï쳌¬ ï쳌¤ and second , appropriate ï쳌± ï쳌¬ ï쳌¤ government agencies to maximize the for elsewhere inAustralia , for re - supply of material for taxonomic and biosystematic research benefits derived a nominated sample ; for full taxonomic consignment from these collections . for the nominated sample ; and for assessment of op - â?¢ ï쳌¡ ï쳌© ï쳌­ ï쳌³ shall use its best endeavors to collaborate with tions for large scale long term supply of material for non - AIMS scientists based in ï쳌± ï쳌¬ ï쳌¤ in all aspects of its the nominated sample . biodiscovery research relating to ï쳌± ï쳌¬ ï쳌¤ samples . â?? An appropriate ï쳌± ï쳌¬ ï쳌¤ collaborator , first , or Australian â?¢ ï쳌¡ ï쳌© ï쳌­ ï쳌³ shall use reasonable endeavors to inform the appro - collaborator , second , will share in any patent rights / priate ï쳌± ï쳌¬ ï쳌¤ government agencies of any opportunities for terms to leads whose discovery and / or development biotechnology industry capacity building , value adding , has involved an overseas party . or joint venture investments to allow those opportunities â?? The share of monetary benefits to be paid to AIMS to be captured for the benefit of the State . or another Australian collaborator will be stipulated â?¢ If a lead emerges and ï쳌¡ ï쳌© ï쳌­ ï쳌³ derives net royalty income , and fair and commensurate with their input to the ï쳌¡ ï쳌© ï쳌­ ï쳌³ shall pay ï?? . ï?? % of the net royalty income to the state process . ( if non - ï쳌¡ ï쳌© ï쳌­ ï쳌³ ï쳌± ï쳌¬ ï쳌¤ - based scientists also make intellectual â?? Development of any leads will recognize ï쳌± ï쳌¬ ï쳌¤ â?? s or other inputs to the discovery of such a lead , ï쳌¡ ï쳌© ï쳌­ ï쳌³ may negotiate parts of Australiaâ??s rights as the place of origin . a distribution of part of the remaining net royalty income to those scientists and / or their organizations ) . Benefits â?? This clause continues to apply despite the possible â?¢ ï쳌¡ ï쳌© ï쳌­ ï쳌³ will provide an annual report , summarizing its bio - termination of the agreement . discovery research using ï쳌± ï쳌¬ ï쳌¤ samples . â?¢ ï쳌¡ ï쳌© ï쳌­ ï쳌³ will provide appropriate ï쳌± ï쳌¬ ï쳌¤ resource manage - Intellectual property â?? confidential information ment agencies with detailed collection data for new ï쳌± ï쳌¬ ï쳌¤ â?¢ Information provided by ï쳌¡ ï쳌© ï쳌­ ï쳌³ to ï쳌± ï쳌¬ ï쳌¤ regarding its research samples . will be ï쳌¡ ï쳌© ï쳌­ ï쳌³ â?? intellectual property and in some cases ï쳌¡ ï쳌© ï쳌­ ï쳌³ â?¢ Where practical , or where stipulated in a permit or per - will require the State to hold such information â?? commer - mission , a preserved voucher specimen shall be lodged cial in confidence . â?쳌 ï?? ï?? ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ are not considered threatened or endangered and proper ing whether or not to issue an access permit , the Minister collection methods are used , the environmental impact consider the precautionary principle and noted that this may be minimal . Secondary collections of a specific would require an amendment to section ï?? ï?? ï?? of the ï쳌¥ ï쳌° ï쳌¢ ï쳌£ ï쳌¡ species , conducted after a lead has been identified , ( V ï쳌¯ ï쳌µ ï쳌­ ï쳌¡ ï쳌² ï쳌¤ ï?? ï?? ï?? ï?? ) . Section ï?? ï?? ï?? of the Act requires the may first require an environmental impact and species Minister to take account of the precautionary principle distribution analysis to determine the viability and in relation to making specified decisions set out in a table ecological sustainability of the proposed second or any under the Act . The Act explains the principle as follows : subsequent collection ( V ï쳌¯ ï쳌µ ï쳌­ ï쳌¡ ï쳌² ï쳌¤ ï?? ï?? ï?? ï?? ) . â?? lack of full scientific certainty should not be used as a ï쳌¡ ï쳌© ï쳌­ ï쳌³ went further , proposing increasingly stringent reason for postponing a measure to prevent degradation requirements depending on the nature of collection of the environment where there are threats of serious or ( V ï쳌¯ ï쳌µ ï쳌­ ï쳌¡ ï쳌² ï쳌¤ ï?? ï?? ï?? ï?? ) . For primary collections , allowable irreversible environmental damage â?쳌 . This recommendation collection methods and procedures were desirable , which was reflected in the draft regulation which requires the would ensure minimal environmental impact and avoid - Minister to take account of various matters before mak - ance of rare species . For medium - scale secondary collec - ing a decision to grant a permit , one of which is that â?? the tion , there should be a requirement for a separate permit as proposed access will , taking into account the precautionary the re - collection would be targeted on a particular organ - principle , be ecologically sustainable and consistent with 71 ism , noting the option of species - specific environmental the conservation of Australiaâ??s biological diversity â?쳌 . assessment . For large - scale collections , there should be In considering whether this paragraph is satisfied , the full - scale environmental assessment and mandatory con - Minister â?? must consider whether the proposed access current investigation of alternatives such as synthesis or may adversely affect : a ) the conservation status of any culture for long - term and large - scale supply . species or population , or b ) any ecosystem or ecological 72 In general , industry submissions did not make detailed community â?쳌 . comments about environmental issues , but support for The Inquiry also considered and made recommenda - conservation and sustainable use was implicit in many tions relating to proposals that would promote further comments regarding the need to ensure continuing access conservation - oriented research . This was in response , for to biological resources . To take one example , BioProspect example , to comments by the Queensland government that stated that its corporate mission statement was based on the bioprospecting had significantly enhanced the discovery ï쳌£ ï쳌¢ ï쳌¤ . Key elements which the company insists be included and documentation ofAustraliaâ??s biodiversity , yet this out - in its contracts are as follows ( V ï쳌¯ ï쳌µ ï쳌­ ï쳌¡ ï쳌² ï쳌¤ ï?? ï?? ï?? ï?? ) : access is come had not always been a mandatory permitting require - strictly on the basis of sustainable access and contingent ment.A frequently cited example is the results of the agree - on agreement to collect only the minimal quantity required ments between AstraZeneca R & D Griffith University and to satisfy screening for biological activity ; all collections the Queensland Museum and the Queensland Herbarium . are â?? vouchered â?쳌 and identified by qualified taxonomists , The submission from Professor Quinn , the Director of with voucher specimen libraries maintained by the state , AstraZeneca R & D Griffith University and the industry for example , in herbaria or museums ; no extract collec - representative on the Inquiryâ??s reference group , revealed tions of endangered or protected species are ever collected that collaboration with the Herbarium to date had resulted from the wild ( collections of protected species only oc - in the discovery of ï?? ï?? new plant species ; new populations cur if material is sustainably available from cultivated of threatened species in remote areas , providing the ge - or farmed collections ) ; and any requirement for further netic material which can be used to propagate the species ; material is from cultivated or farmed collections or , in records of weed encroachment in native forests which are rare circumstances , from proven sustainable collections useful for forest management ; and the creation of new from natural resources . distribution records in the Herbarium . Collaboration with The Inquiry reportâ??s recommendations for environmen - the Museum had resulted in the discovery of approxi - tal assessment were generally reflected in the resulting mately ï?? , ï?? ï?? ï?? new species and provision of infrastructure draft regulations . However , the major difference between to define accurately the distribution of marine sponges in the approach of the report and that of the regulations was Queensland and adjacent waters ; this provided data which the addition in the regulations of the scheme for environ - will eventually produce taxonomic expertise in these areas ment assessment by public notice . In effect , this allows a and is of great value in further understanding of marine shorter , less complex approach to environmental assess - biota ( V ï쳌¯ ï쳌µ ï쳌­ ï쳌¡ ï쳌² ï쳌¤ ï?? ï?? ï?? ï?? ) . ment in situations where environmental impacts are likely To maximize potential scientific outcomes , the to be more than negligible . This criterion , while not defined Queensland governmentâ??s submission recommended that in the regulations , would appear to require environmental there be a strict requirement that representative samples assessment of a proposed bioprospecting activity which of all taxa obtained from biodiscovery be lodged with a does not reach the ï쳌¥ ï쳌° ï쳌¢ ï쳌£ ï쳌¡ â?? s threshold for assessment of an State or Australian government museum accredited by the action â?? that has , will have , or is likely to have a significant Convention on International Trade in Endangered Species 70 impact on certain aspects of the environment â?쳌 . of Wild Fauna and Flora ( ï쳌£ ï쳌© ï쳌´ ï쳌¥ ï쳌³ ) together with collection The Inquiry report also recommended that in decid - data and any other information that may contribute to the ï?? ï?? ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : A ï쳌µ ï쳌³ ï쳌´ ï쳌² ï쳌¡ ï쳌¬ ï쳌© ï쳌¡ scientific knowledge ofAustralian biodiversity ( V ï쳌¯ ï쳌µ ï쳌­ ï쳌¡ ï쳌² ï쳌¤ ing can harm the environment , for example , through over ï?? ï?? ï?? ï?? ) . The Inquiry recommended that the regulations re - collecting ( a particular danger in relation to rare and en - quire the parties to the contract ( in practice , this would dangered species ) ; the introduction of exotic species and usually be the collecting body ) to lodge voucher specimens pathogens to habitats visited by collectors ; and / or the use and information about the collection with a ï쳌£ ï쳌© ï쳌´ ï쳌¥ ï쳌³ - approved of inappropriate collection methods that result in collat - authority in Australia which has facilities for preservation eral damage to habitats or biota other than those being ( and further dissemination , when appropriate ) of this mate - targeted ( B ï쳌¡ ï쳌© ï쳌¬ ï쳌¥ ï쳌¹ ï?? ï?? ï?? ï?? ) . The Committee also commented rial ( V ï쳌¯ ï쳌µ ï쳌­ ï쳌¡ ï쳌² ï쳌¤ ï?? ï?? ï?? ï?? ) . This recommendation has not been that much bioprospecting involves the collection of only reflected in the draft regulations . small quantities of material and noted the potential for Finally , the Inquiry report recommended that the regu - synthesizing active chemicals found in material , making lations and the model contract include a requirement that further collections unnecessary ( B ï쳌¡ ï쳌© ï쳌¬ ï쳌¥ ï쳌¹ ï?? ï?? ï?? ï?? ) . at least some of the benefits under the contract ( whether The Committee commented that existing legislation in of a monetary or nonmonetary nature ) should promote many parts of Australia already addresses negative envi - biodiversity conservation in the area covered by the agree - ronmental impacts and is being used or could be used to ment ( V ï쳌¯ ï쳌µ ï쳌­ ï쳌¡ ï쳌² ï쳌¤ ï?? ï?? ï?? ï?? ) . This recommendation evolved control bioprospecting , referring to the Victorian approach from suggestions in some submissions , such as that by and to the ï쳌¥ ï쳌° ï쳌¢ ï쳌£ ï쳌¡ ( B ï쳌¡ ï쳌© ï쳌¬ ï쳌¥ ï쳌¹ ï?? ï?? ï?? ï?? ) . The Committee also re - the Australian Conservation Foundation , that â?? â?¦ perhaps ferred to â?? positive impacts â?쳌 of bioprospecting , citing , for an identified percentage of the monetary benefits gained example , the outcomes of the research referred to above from the access [ could be ] placed into an environmental ( B ï쳌¡ ï쳌© ï쳌¬ ï쳌¥ ï쳌¹ ï?? ï?? ï?? ï?? ) . The Committee mentioned suggestions fund , managed by independent trustees , for conservation that voucher specimens and associated information be purposes â?쳌 ( V ï쳌¯ ï쳌µ ï쳌­ ï쳌¡ ï쳌² ï쳌¤ ï?? ï?? ï?? ï?? ) . BioProspect also supported a lodged with museums and herbaria and comments about model where royalty income derived from bioprospecting the potential value of royalties and other payments as a would reside in a fund and be distributed to protect biodi - source of revenue for conservation purposes . However , versity and reward the use of indigenous knowledge for the it also acknowledged the view of the Department of the sustainable development of the biota ( V ï쳌¯ ï쳌µ ï쳌­ ï쳌¡ ï쳌² ï쳌¤ ï?? ï?? ï?? ï?? ) . Environment and Heritage that information collected in the The Inquiry decided that , given the difficulty of predict - course of bioprospecting may make a greater contribution to ing the nature and size of benefits under future contracts conservation than any monetary returns ( B ï쳌¡ ï쳌© ï쳌¬ ï쳌¥ ï쳌¹ ï?? ï?? ï?? ï?? ) . and the fact that potential providers of resources had not The Committee concluded its discussion of the en - been consulted on such a proposal ( which could affect their vironmental issues involved in bioprospecting with the share of benefits ) , a preferable approach was to attempt to observation that the conservation of biodiversity is funda - ensure that at least some benefits under the contract were mental to biodiscovery and to building industries based on used to promote biodiversity in the area covered by the these discoveries . Although its terms of reference did not contract ( V ï쳌¯ ï쳌µ ï쳌­ ï쳌¡ ï쳌² ï쳌¤ ï?? ï?? ï?? ï?? ) . Such terms are not unknown : include a requirement to assess the adequacy with which for example , ï쳌£ ï쳌¡ ï쳌¬ ï쳌­ used ï?? ï?? ï?? ï?? , ï?? ï?? ï?? ï쳌µ ï쳌³ ï쳌¤ from its agreement biological resources are being conserved , the report noted with ï쳌¡ ï쳌­ ï쳌² ï쳌¡ ï쳌¤ for the conservation of rare and endangered evidence regarding the lack of resources for conservation flora and fauna and ï?? ï?? ï?? ï?? , ï?? ï?? ï?? ï쳌µ ï쳌³ ï쳌¤ for other conservation and the lack of protection for some biodiversity and activities ( ï쳌´ ï쳌¥ ï쳌® K ï쳌¡ ï쳌´ ï쳌¥ and L ï쳌¡ ï쳌© ï쳌² ï쳌¤ ï?? ï?? ï?? ï?? ) . stated its belief that it is essential that state , territory , and The draft regulations reflect this recommendation by Australian government conservation programs compre - including , among the circumstances the Minister has to hensively coverAustraliaâ??s biodiversity and are adequately consider in deciding whether to grant a permit , that â?? the funded to maintain it . The Committee recommended that Minister believes , on reasonable grounds , that some of the Department of the Environment and Heritage give a the benefits of access will , if practicable , be used for â?? high priority to continuing its work with state and territory biodiversity conservation in the area from where the governments to develop a nationally consistent approach 73 relevant biological resources were taken â?쳌 . A regula - to establishing conservation areas that comprehensively tion along these lines could also be drafted to address cover all species and ecosystems â?쳌 ( B ï쳌¡ ï쳌© ï쳌¬ ï쳌¥ ï쳌¹ ï?? ï?? ï?? ï?? ) . the Inquiryâ??s recommendation regarding the lodging of The Department ofAgriculture , Fisheries , and Forestry voucher specimens . has , in consultation with other interested government agen - The terms of reference of the Bailey report also re - cies ( particularly the Department of the Environment and quired it to inquire into and report on â?? the impacts on and Heritage ) , prepared a response to the recommendations of benefits to the environment â?쳌 of bioprospecting ( B ï쳌¡ ï쳌© ï쳌¬ ï쳌¥ ï쳌¹ the Bailey Committee . The response was submitted to the ï?? ï?? ï?? ï?? ) . The Committee acknowledged that bioprospect - Committee in September ï?? ï?? ï?? ï?? . ï?? ï?? ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ The Convention on Biological Diversity ( CBD ) , ectualnRFA ) the Agreement on Trade - Related Aspects of Intelleaty Property Rights ( TRIPS ) , and the International Tr Go Plant Genetic Resources for Food and Agriculture ( ITP There have been few , if any , sustained and rigorous cri - substantially addresses these concerns . Australiaâ??s com - tiques ofAustraliaâ??s international positions on the relation - munication notes that ï쳌· ï쳌´ ï쳌¯ members had proposed the ship among the ï쳌£ ï쳌¢ ï쳌¤ , ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ , and the negotiations which led following amendments to Article ï?? ï?? . ï?? ( b ) to provide ad - to the ï쳌© ï쳌´ ï쳌° ï쳌§ ï쳌² ï쳌¦ ï쳌¡ . This probably reflects the complexity of the ditional conditions for patentability : a ) the identification of issues , as well as the lack of opportunities and resources the source of the genetic material ; b ) the identification of available to interested parties to develop and express their related traditional knowledge used to obtain that material ; concerns . Several issues relating to these agreements , par - c ) evidence of fair and equitable benefit sharing ; and d ) ticularly with respect to intellectual property and tradi - evidence of prior informed consent from the government tional knowledge , remain controversial at the intentional of the traditional community for the exploitation of the level . The following is a summary of Australiaâ??s positions subject - matter of the patent . on these agreements . The communication expresses two reservations about these proposals . The first is that Australia feels that more The CBD and TRIPS analysis needs to be undertaken into the most effective way of ensuring that access to material that is subsequently the One of the principles of ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ is that national laws should subject of a patent application was sourced in compliance provide patent protection to inventions , without discrimi - with the provisions of the ï쳌£ ï쳌¢ ï쳌¤ . Rather than an amendment nation as to the field of technology concerned ( Article to the ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ Agreement , more efforts should be made to ex - 74 ï?? ï?? . ï?? ) . In response to concerns about the patenting of amine the potential for compatible implementation of both plants and animals , members of the ï쳌· ï쳌´ ï쳌¯ agreed to an conventions at the level of national legislation and policy - optional exception to this principle which provides that making . It should be noted that the draft access regulations members may exclude from patentability â?? plants and do not impose on the patent system requirements of this animals and other microorganisms , and essentially bio - nature , which , even if they were to occur , would be more logical processes for the production of plants and animals appropriately placed in patent legislation than in environ - other than non - biological and micro - biological processes â?쳌 ment legislation . They do , however , include provisions ( Article ï?? ï?? . ï?? ( b ) ) . Australia , in common with many of its requiring prior informed consent fair and equitable benefit key trading partners , including the United States , Japan , sharing , and adequate valuing of indigenous knowledge in the European Union , and New Zealand , allows for the the benefit - sharing contract . As noted above , the Inquiry patenting of plants , microorganisms , and related biological report recommended that ï쳌© ï쳌° ï쳌¡ consider amending patent materials , provided that these meet the usual standards of 75 law to require proof of source and , where appropriate , proof for patentability . prior informed consent , as a prerequisite for granting a Since ï?? ï?? ï?? ï?? a review of this Article has been underway patent ( V ï쳌¯ ï쳌µ ï쳌­ ï쳌¡ ï쳌² ï쳌¤ ï?? ï?? ï?? ï?? ) . Australiaâ??s second reservation in the ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ Council . The Australian government submit - relates to the most appropriate location in the Agreement ted its views in a communication to the ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ Council in 76 for any amendments : it is suggested that Article ï?? ï?? , which September ï?? ï?? ï?? ï?? . Australiaâ??s view is that the review is stipulates conditions to be fulfilled by patent applications , relatively narrow ; that is , it is concerned with the effective - may be more suitable than Article ï?? ï?? . ness of the optional exclusion to patentability . Australia In summary , Australiaâ??s position is that a specific acknowledges , nevertheless , the importance of broader amendment to ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ should only be considered when a issues related to the provision , such as access to genetic complete survey of the situation has been made ( within that resources and protection of traditional knowledge , and sup - context ) Australia would support the examination of op - ports the work of ï쳌· ï쳌© ï쳌° ï쳌¯ â?? s Intergovernmental Committee on tions for disclosing information about the source of biologi - Intellectual Property and Genetic Resources , Traditional cal material into the patent application process . Following Knowledge and Folklore on these issues . this process , consideration could be given to whether this Australia considers that these broader issues would necessitates an amendment to ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ . With respect to pos - be more appropriately approached under the Article ï?? ï?? . ï?? sible initiatives at the national and local level to address review of the implementation of the ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ Agreement . One the problems of protection of biodiversity and indigenous of these issues is the relationship between the Agreement knowledge , Australiaâ??s communication outlines the draft and the ï쳌£ ï쳌¢ ï쳌¤ ( particularly Article ï?? ( j ) on the role of indig - access and benefit - sharing regulations , the Bailey report , enous communities in preserving biodiversity , and Article the report by J ï쳌¡ ï쳌® ï쳌« ï쳌¥ ( ï?? ï?? ï?? ï?? ) and , with respect to artistic / ï?? ï?? on access to genetic resources ) . It is Australiaâ??s view cultural expression ( as distinct from ecological knowledge ) , that these agreements are not in conflict ; indeed , if properly eight case studies where the existing intellectual property managed , the national implementation of the obligations 77 under the two agreements could result in a regime that system has been used to protect traditional knowledge . ï?? ï?? ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : A ï쳌µ ï쳌³ ï쳌´ ï쳌² ï쳌¡ ï쳌¬ ï쳌© ï쳌¡ â?¢ Article ï?? ï?? . ï?? ( d ) and Article ï?? are ambiguous with The International Treaty on Plant Genetic regard to the scope and application of intellectual Resources for Food and Agriculture property rights by participating countries.Australia Australia voted for adoption of the ï쳌© ï쳌´ ï쳌° ï쳌§ ï쳌² ï쳌¦ ï쳌¡ at the ï?? ï?? st considers that ï?? ï?? . ï?? ( d ) and associated Articles do session of the Conference of the UN Food and Agriculture not impinge on national intellectual property rights Organization in Rome on ï?? November ï?? ï?? ï?? ï?? , signed the laws and polices . Australia will insist on respect in ï쳌© ï쳌´ ï쳌° ï쳌§ ï쳌² ï쳌¦ ï쳌¡ on ï?? ï?? June ï?? ï?? ï?? ï?? , and is expected to ratify it . In this ï쳌© ï쳌´ ï쳌° ï쳌§ ï쳌² ï쳌¦ ï쳌¡ for the intellectual property laws of the course of the long and somewhat tortuous negotia - member countries . To do otherwise would under - tions on the ï쳌© ï쳌´ ï쳌° ï쳌§ ï쳌² ï쳌¦ ï쳌¡ , Australia was subjected to criticism mine this agreement . from some civil organizations , particularly the Rural â?¢ The ï쳌© ï쳌´ ï쳌° ï쳌§ ï쳌² ï쳌¦ ï쳌¡ cannot and does not change the exist - Advancement Foundation International ( ï쳌² ï쳌¡ ï쳌¦ ï쳌© ) ( now the ing rights and obligations of the contracting parties Action Group on Erosion Technology and Concentration under other international agreements . ( ï쳌¥ ï쳌´ ï쳌£ Group ) ) , for its approach to certain issues in the nego - â?¢ It will be essential that the material transfer agree - tiations , particularly intellectual property issues . In voting ments which underpin this ï쳌© ï쳌´ ï쳌° ï쳌§ ï쳌² ï쳌¦ ï쳌¡ are commer - 78 for the ï쳌© ï쳌´ ï쳌° ï쳌§ ï쳌² ï쳌¦ ï쳌¡ , Australia issued a statement to â?? em - cially realistic in order to facilitate and encourage phasize certain aspects of [ its ] position and to avoid any exchange and development of plant genetic re - misunderstanding on the possible future implementation sources for food and agriculture for the benefit of of [ the ] treaty . â?쳌 Australia expressed its belief â?? in the global all parties . need for an effective and workable system of exchange â?¢ It is desirable that the list of crops under the multi - for plant genetic resource for food and agriculture â?쳌 and its lateral system be assessed and extended . Exclusion commitment to ensuring â?? that a workable system , based of some important crops has the potential to distort on the provisions of [ the ] text , is achieved in practice . â?쳌 the system of exchange with negative implications Australia emphasized four issues â?? considered necessary â?쳌 79 for the implementation of the ï쳌© ï쳌´ ï쳌° ï쳌§ ï쳌² ï쳌¦ ï쳌¡ : for the objectives of the ï쳌© ï쳌´ ï쳌° ï쳌§ ï쳌² ï쳌¦ ï쳌¡ . Conclusions The development of Australiaâ??s draft regulations on ac - With respect to possible lessons for parties and other cess and benefit sharing has been a long , complex , and stakeholders involved in the development and implementa - in some respects , controversial process , but it is now tion of access and benefit - sharing schemes in the future , close to completion . Initially , progress was assisted by it is suggested that providers of biological resources have the existence of adequate funds for staff and administra - realistic expectations about potential benefits from agree - tive costs through Biotechnology Australia and support at ments and consider focusing on negotiating up - front and the political level . However , resource constraints subse - in - kind benefits , rather than focusing on potential monetary quently slowed progress during Australian financial years benefits ( this should not , however , exclude agreement over ï?? ï?? ï?? ï?? â?? ï?? ï?? and ï?? ï?? ï?? ï?? â?? ï?? ï?? . This was remedied in mid - ï?? ï?? ï?? ï?? fair and reasonable royalties ) . Providers should also ex - with renewed funding from Biotechnology Australia for ercise some caution about the users with which they deal , the next four years . Some amendments to the draft regu - preferring those which have a good track record as bio - lations can be expected , based on submissions on them prospectors . It is , of course , too early to assess the impact ( the relationship between native title legislation and the of the regulations , as well that of a nationally consistent draft regulations has proved to be particularly complex ) ; system , on access to , and benefit sharing from , biologi - the draft model benefit - sharing agreements remain to be cal resources , but there would probably be some value in completed ; and administrative arrangements for handling conducting a review of the system , from the perspective permit applications and their associated benefit - sharing of all parties and stakeholders , two to three years after its agreements are being finalized . establishment . Acknowledgements I would like to thank Jacqueline Gellatly , my predecessor for his comments on this chapter . Unless otherwise in - dicated , the views expressed are mine , not those of the on access and benefit - sharing issues , for her dedication to Australian government . promoting this difficult issue , and Geoff Burton , Director , Access Taskforce ( now Genetic Resources Management ) , ï?? ï?? ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ References ï쳌¡ ï쳌® ï쳌º ï쳌¥ ï쳌£ ï쳌£ . ï?? ï?? ï?? ï?? . Implementation of and implications of ratifica - and Heritage , Australia . ï쳌µ ï쳌² ï쳌¬ : http : / / www.deh.gov.au / biodiversity / publications / national - report / index.html tion of the Convention on Biological Diversity . Report to First Ministers from the Australian and New Zealand E ï쳌® ï쳌¶ ï쳌© ï쳌² ï쳌¯ ï쳌® ï쳌­ ï쳌¥ ï쳌® ï쳌´ A ï쳌µ ï쳌³ ï쳌´ ï쳌² ï쳌¡ ï쳌¬ ï쳌© ï쳌¡ . ï?? ï?? ï?? ï?? . EPBC ACT â?? Administrative Environment and Conservation Council ( ï쳌¡ ï쳌® ï쳌º ï쳌¥ ï쳌£ ï쳌£ ) in guidelines on significance . Department of the consultation with relevant Ministerial Councils . Canberra , Environment and Heritage , Australia . ï쳌µ ï쳌² ï쳌¬ : http : / / Australia . www.deh.gov.au / epbc / assessmentsapprovals / guidelines / administrative / index.html . ï쳌¡ ï쳌® ï쳌º ï쳌¥ ï쳌£ ï쳌£ . ï?? ï?? ï?? ï?? . Access to Australiaâ??s genetic resources . Round table discussion of the Australian and New Zealand E ï쳌® ï쳌¶ ï쳌© ï쳌² ï쳌¯ ï쳌® ï쳌­ ï쳌¥ ï쳌® ï쳌´ A ï쳌µ ï쳌³ ï쳌´ ï쳌² ï쳌¡ ï쳌¬ ï쳌© ï쳌¡ . ï?? ï?? ï?? ï?? . National objectives and Environment and Conservation Council ( ï쳌¡ ï쳌® ï쳌º ï쳌¥ ï쳌£ ï쳌£ ) , ï?? ï?? targets for biodiversity conservation , ï?? ï?? ï?? ï?? â?? ï?? ï?? ï?? ï?? . March ï?? ï?? ï?? ï?? . Canberra , Australia . Department of the Environment and Heritage , Australia . ï쳌µ ï쳌² ï쳌¬ : http : / / www.deh.gov.au / biodiversity / publications / B ï쳌¡ ï쳌© ï쳌¬ ï쳌¥ ï쳌¹ F . ï?? ï?? ï?? ï?? . Bioprospecting : Discoveries changing the objectives / . future . House of Representatives Standing Committee on Primary Industries and Regional Services . Canberra , G ï쳌¯ ï쳌¶ ï쳌¥ ï쳌² ï쳌® ï쳌­ ï쳌¥ ï쳌® ï쳌´ ï쳌¯ ï쳌¦ W ï쳌¥ ï쳌³ ï쳌´ ï쳌¥ ï쳌² ï쳌® A ï쳌µ ï쳌³ ï쳌´ ï쳌² ï쳌¡ ï쳌¬ ï쳌© ï쳌¡ . ï?? ï?? ï?? ï?? . A Australia . Biodiversity Conservation Act for Western Australia , Consultation Paper . Department of Conservation and C ï쳌¯ ï쳌­ ï쳌­ ï쳌¯ ï쳌® ï쳌· ï쳌¥ ï쳌¡ ï쳌¬ ï쳌´ ï쳌¨ ï쳌¯ ï쳌¦ A ï쳌µ ï쳌³ ï쳌´ ï쳌² ï쳌¡ ï쳌¬ ï쳌© ï쳌¡ . ï?? ï?? ï?? ï?? . Australian bio - Land Management , Western Australia . ï쳌µ ï쳌² ï쳌¬ : http : technology : A national strategy . Commonwealth / / www.calm.wa.gov.au / biocon_act_consult.pdf . Biotechnology Ministerial Council , Australia . ï쳌µ ï쳌² ï쳌¬ : http : / / www.biotechnology.gov.au / library / content_library / BA_ J ï쳌¡ ï쳌® ï쳌« ï쳌¥ T . ï?? ï?? ï?? ï?? . Our culture : Our future â?? Report on Australian Biotech_strategy.pdf . indigenous cultural and intellectual property rights . Australian Institute of Aboriginal and Torres Strait ï쳌£ ï쳌³ ï쳌· ï쳌§ . ï?? ï?? ï?? ï?? . Managing access to Australiaâ??s biological Islander Studies and the Aboriginal and Torres Strait resources : Developing a nationally consistent approach . Islander Commission . Canberra , Australia . A discussion paper prepared by the Commonwealth - State Working Group ( ï쳌£ ï쳌³ ï쳌· ï쳌§ ) on Access to Australiaâ??s ï쳌® ï쳌² ï쳌­ ï쳌­ ï쳌£ . ï?? ï?? ï?? ï?? . Australiaâ??s genetic and biochemical resourc - Biological Resources . Canberra , Australia . ï쳌µ ï쳌² ï쳌¬ : http : es â?? A nationally consistent approach . Resolution ï?? . ï?? ï?? . / / www.deh.gov.au / biodiversity / science / access / cswg / Annex A . p ï?? ï?? ï?? â?? ï?? ï?? ï?? in National Resource Management index.html . Ministerial Council , Record and Resolutions , Third Meeting , Sydney , ï?? ï?? October ï?? ï?? ï?? ï?? . Australian ï쳌¤ ï쳌¥ ï쳌³ ï쳌´ . ï?? ï?? ï?? ï?? . The national strategy for the conservation of Government . ï쳌µ ï쳌² ï쳌¬ : http : / / www.mincos.gov.au / pdf / nrmmc_ Australiaâ??s biological diversity . Department of the res_ ï?? ï?? . pdf . Environment , Sport and Territories ( ï쳌¤ ï쳌¥ ï쳌³ ï쳌´ ) , Australia . ï쳌µ ï쳌² ï쳌¬ : http : / / www.deh.gov.au / biodiversity / publications / strategy / Q ï쳌µ ï쳌¥ ï쳌¥ ï쳌® ï쳌³ ï쳌¬ ï쳌¡ ï쳌® ï쳌¤ G ï쳌¯ ï쳌¶ ï쳌¥ ï쳌² ï쳌® ï쳌­ ï쳌¥ ï쳌® ï쳌´ . ï?? ï?? ï?? ï?? . Queensland Biodiscovery index.html . Policy Discussion Paper . Department of State Development and Innovation , Queensland , Australia . ï쳌¤ ï쳌° ï쳌­ ï쳌£ ï?? ï?? ï?? ï?? . Access to Australiaâ??s biological resources : A discussion paper . A paper prepared for the Coordination ï쳌´ ï쳌¥ ï쳌® K ï쳌¡ ï쳌´ ï쳌¥ K . and S . L ï쳌¡ ï쳌© ï쳌² ï쳌¤ . ï?? ï?? ï?? ï?? . The commercial use of bio - Committee on Science and Technology . Department diversity : Access to genetic resources and benefit - sharing . of the Prime Minister and Cabinet ( ï쳌¤ ï쳌° ï쳌­ ï쳌£ ) , Office of Earthscan , London , UK . the Chief Scientist . Australian Government Publishing V ï쳌¯ ï쳌µ ï쳌­ ï쳌¡ ï쳌² ï쳌¤ J . ï?? ï?? ï?? ï?? . Access to biological resources in Service , Canberra , Australia . Commonwealth areas . Commonwealth of Australia . E ï쳌® ï쳌¶ ï쳌© ï쳌² ï쳌¯ ï쳌® ï쳌­ ï쳌¥ ï쳌® ï쳌´ A ï쳌µ ï쳌³ ï쳌´ ï쳌² ï쳌¡ ï쳌¬ ï쳌© ï쳌¡ . ï?? ï?? ï?? ï?? . Australiaâ??s national report Canberra , Australia . ï쳌µ ï쳌² ï쳌¬ : http : / / www.deh.gov.au / to the Fourth Conference of the Parties to the Convention biodiversity / science / access / inquiry / pubs / abrca.pdf on Biological Diversity . Department of the Environment Endnotes 1 8 Senator the Hon . Robert Hill , â?? Bioprospecting Regulations Regulation ï?? A . ï?? ï?? ( ï?? ) . Released for Public Comment , â?쳌 ï?? September ï?? ï?? ï?? ï?? . The 9 Regulation ï?? A . ï?? ï?? ( ï?? ) ( d ) and ( ï?? ) . Department of Environment and Heritageâ??s homepage on 10 Regulation ï?? A . ï?? ï?? ( ï?? ) ( a } - ( c ) . Access to Genetic Resources is at the following address : http : 11 Regulation ï?? A . ï?? ï?? â?? â?? Meaning of access provider . â?쳌 / / www.ea.gov.au / biodiversity / science / access / index.html . 2 12 s ï?? ï?? ï?? ( ï?? ) and ( ï?? ) ( a ) - ( d ) . s ï?? ï?? ï?? ( ï?? ) and ( ï?? ) . The Secretary is the head of the Department of 3 the Environment and Heritage which administers the ï쳌¥ ï쳌° ï쳌¢ ï쳌£ ï쳌¡ . s ï?? ( ï?? ) ( a ) , ( b ) and ( c ) . 13 4 Regulation ï?? A . ï?? ï?? . â?? Commonwealth areas â?? are defined at s ï?? ï?? ï?? of the ï쳌¥ ï쳌° ï쳌¢ ï쳌£ ï쳌¡ . 14 5 Regulation ï?? ï?? . ï?? ï?? ( ï?? ) ( g ) ( i ) - ( xii ) . â?? Commonwealth marine area is defined at s ï?? ï?? of the ï쳌¥ ï쳌° ï쳌¢ ï쳌£ ï쳌¡ . 15 For an explanation of the legal and constitutional framework of Regulation ï?? A . ï?? ï?? ( ï?? ) . Australiaâ??s marine areas ( which , as a result of agreements arising 16 Regulation ï?? A . ï?? ï?? ( ï?? ) . from Australiaâ??s federal structure , are somewhat complex ) , see 17 Regulation ï?? A . ï?? ï?? . V ï쳌¯ ï쳌µ ï쳌­ ï쳌¡ ï쳌² ï쳌¤ , ï?? ï?? ï?? ï?? : ï?? ï?? ï?? - ï?? ï?? ï?? ( Appendix ï?? ï?? ) . 18 6 Regulation ï?? A . ï?? ï?? . Regulation ï?? A . ï?? l . 7 19 Regulation ï?? A . ï?? ï?? ( ï?? ) . Regulation ï?? A . ï?? ï?? ( ï?? ) . ï?? ï?? ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? : A ï쳌µ ï쳌³ ï쳌´ ï쳌² ï쳌¡ ï쳌¬ ï쳌© ï쳌¡ 20 Regulation ï?? A . ï?? ï?? ( ï?? ) ( a ) - ( e ) . and Elizabeth Evans - Illidge , research scientist , the Australian Institute of Marine Science ( Townsville , Queensland ) . 21 Regulation ï?? A . ï?? l ( l ) and ( ï?? ) . Each reference to â?? days â?쳌 is to â?? busi - 43 The three parks ( and their representatives ) are as follows : Kakadu ness days â?쳌 which are defined under s ï?? ï?? ï?? of the ï쳌¥ ï쳌° ï쳌¢ ï쳌£ ï쳌¡ . ( Northern Land Council ) and Uluru - Kata Tjuta ( Central Land 22 Regulation ï?? A . ï?? ï?? . Regulation ï?? A . ï?? ï?? ( ï?? ) provides that the Minister Council ) in the Northern Territory and Booderee on the south coast may publish in the Gazette a model benefit - sharing agreement as a of New South Wales . guide for applicants . At the time of writing several model benefit - 44 This work was summarized in Chapter ï?? ( V ï쳌¯ ï쳌µ ï쳌­ ï쳌¡ ï쳌² ï쳌¤ ï?? ï?? ï?? ï?? ) . sharing agreements were being drafted . 45 23 The expression â?? First Ministers â?쳌 refers to the Australian Prime s ï?? ï?? of the ï쳌¥ ï쳌° ï쳌¢ ï쳌£ ï쳌¡ explains a controlled action as follows : â?? An action Minister and to the heads of State and Territory Governments . that a person proposes to take is a controlled action if the taking of 46 the action by the person without approval under Part ï?? [ Approval These meetings included the Ad hoc Open - ended Working of actions ] for the purposes of a provision of Part ï?? [ Requirements Group on the Implementation of Article ï?? ( j ) , the Fifth and Sixth for environmental approvals - Requirements relating to matters of Conferences of the Parties ( î?? î?¡ î?© ï?? and î?? î?¡ î?© ï?? ) to the ï쳌£ ï쳌¢ ï쳌¤ ( Nairobi , national environmental significance ] would be prohibited by the May ï?? ï?? ï?? ï?? and The Hague , April , ï?? ï?? ï?? ï?? ) , the second meeting of provision . The provision is a controlling provision for the action . â?쳌 the Panel of Experts ( Montreal , March ï?? ï?? ï?? ï?? ) , the Working Group In other words , controlled actions are subject to assessment and on Access and Benefit - Sharing ( Bonn , October ï?? ï?? ï?? ï?? ï?? ) , the ï쳌· ï쳌© ï쳌° ï쳌¯ approval in accordance with the Act . Intergovernmental Committee on Intellectual Property and Genetic 24 Resources , Traditional Knowledge and Folklore , a ï쳌· ï쳌© ï쳌° ï쳌¯ regional Regulation ï?? A . ï?? ï?? ( ï?? ) . workshop ( Brisbane , June ï?? ï?? ï?? ï?? ) , and meetings associated with 25 Regulation ï?? A . ï?? ï?? ( ï?? ) ( a ) â?? ( d ) . the revision of the ï쳌¦ ï쳌¡ ï쳌¯ International Undertaking on Plant Genetic 26 Regulation ï?? A . ï?? ï?? . Resources and ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ . 27 47 Regulation ï?? A . ï?? ï?? . ï쳌© ï쳌° ï쳌¡ is the agency responsible for patents , designs and trademarks . 28 48 Regulation ï?? ï?? . ï?? ï?? A ( l ) ( a ) , ( b ) , ( c ) and ( d ) . See http : / / www.sd.qld.gov.au / innovation / biotechnology / 29 downloads / biodiscovery_fs.pdf . Regulation ï?? ï?? . ï?? ï?? A ( ï?? ) ( a ) . 49 30 See http : / / www.naturebase.net / biocon_act_pubsubs_summary.pdf s ï?? ï?? ï?? of the ï쳌¥ ï쳌° ï쳌¢ ï쳌£ ï쳌¡ explains that the Governor - General ( Australiaâ??s and http : / / www.naturebase.net / biocon_act_pubsubs.pdf . head of state ) can proclaim Commonwealth reserves over areas of land or sea that the Commonwealth owns ; or that the 50 See Chapter ï?? of V ï쳌¯ ï쳌µ ï쳌­ ï쳌¡ ï쳌² ï쳌¤ ( ï?? ï?? ï?? ï?? ) . Commonwealth or the Director of National Parks leases ; or 51 Regulation ï?? A . ï?? ï?? ( ï?? ) ( a ) and ( b ) . that are in a Commonwealth marine area ; or outside Australia that the Commonwealth has international obligations to protect . 52 This raises issues of â?? exclusivity â?쳌 which are discussed further Examples of reserves ( to give some idea of their diversity ) are below . Christmas Island National Park and Conservancy ; Norfolk Island 53 The legal advice commented that : â?? The Commonwealth has not National Park and Botanic Garden ; the Australian National Botanic legislated to vest property in itself in the biological resources in Gardens ; Royal Australian Navy Weapons Range ( Beecroft [ Commonwealth - owned land ] . â?쳌 Peninsula ) ; Great Australian Bight Marine Park ( Commonwealth 54 The report was researched and written by Terry Janke , at the time a Waters ) ; and Macquarie Island Marine Park . solicitor and principal consultant of Michael Frankel & Company , 31 Regulation ï?? ï?? . ï?? ï?? A ( ï?? ) . under contract with the Australian Institute of Aboriginal and 32 Regulation ï?? A . ï?? ï?? ( ï?? ) ( a ) ( ii ) . Torres Strait Islander Studies , and funded by the Aboriginal and 33 Torres Strait Islander Commission . Regulation ï?? A . ï?? ï?? ( ï?? ) ( j ) . 55 34 The full text of these interviews which were a part of a ra - Regulation ï?? A . ï?? ï?? ( ï?? ) . dio documentary about bioprospecting can be found at http : 35 Regulation ï?? A . ï?? ï?? ( ï?? ) . / / www.abc.net.au / rn / talks / bbing / stories / s ï?? ï?? ï?? ï?? ï?? ï?? . htm ( Background 36 Regulation ï?? ï?? . ï?? ï?? B ( ï?? ) . Briefing : Bioprospecting in Queensland : Oceans of Opportunity , 37 Forests of Concern , ï?? ï?? May ï?? ï?? ï?? ï?? ) . Regulation ï?? ï?? . ï?? ï?? B ( ï?? ) . 56 38 See , for example , the submission from the GeneEthics Network Regulation ï?? ï?? . ï?? ï?? B ( ï?? ) . in association with the Gunggalidda Association , Doomadgee 39 s ï?? ( ï?? ) and ( ï?? ) . Aboriginal Community , Queensland , and evidence presented ( by 40 Regulation ï?? A . ï?? ï?? . Under the Crimes Act ï?? ï?? ï?? ï?? , Section ï?? AA ( ï?? ) telephone ) to the Inquiry hearing on ï?? ï?? May ï?? ï?? ï?? ï?? . ( http : / / scaletext.law.gov.au / html / pasteact / ï?? / ï?? ï?? / ï?? / PA ï?? ï?? ï?? ï?? ï?? ï?? . htm ) , a 57 Cerylid Biosciences , an Australian biotechnology company , penalty unit is currently set at ï?? ï?? ï?? ï?? ï쳌¡ ï쳌µ ï쳌¤ . At the rate of exchange at located in Melbourne , Victoria was formerly known as ExGenix the time of writing , this would be approximately ï?? ï?? ï?? ï쳌µ ï쳌³ ï쳌¤ . and before that as ï쳌¡ ï쳌­ ï쳌² ï쳌¡ ï쳌¤ Discovery Technologies . See http : 41 The governmentâ??s ï?? ï?? ï?? ï?? election policy re - stated this commit - / / www.cerylid.com.au / . ment as follows : â?? The Coalition government has published draft 58 s ï?? ï?? ï?? ï쳌¥ ï쳌° ï쳌¢ ï쳌£ ï쳌¡ . regulations under the ï쳌¥ ï쳌° ï쳌¢ ï쳌£ ï쳌¡ dealing with the management of 59 s ï?? ï?? ï?? ï쳌¥ ï쳌° ï쳌¢ ï쳌£ ï쳌¡ . bio - prospecting in Commonwealth areas . The Commonwealth will 60 take into account public comments and introduce final regulations ï쳌© ï쳌° Australia has not specifically taken up this invitation ; however , governing bio - prospecting activities in Commonwealth areas . â?쳌 interested agencies , including ï쳌© ï쳌° Australia , are currently closely 42 monitoring the work of the ï쳌· ï쳌© ï쳌° ï쳌¯ Intergovernmental Committee The reference group members were , respectively , Katherine on Intellectual Property and Genetic Resources , Traditional Wells ( formerly of the Environmental Defenders Office , Sydney ) , Knowledge and Folklore , which is examining a range of options Professor Ron Quinn ( Director , AstraZeneca R & D , Griffith for the protection of traditional knowledge through intellectual University , Brisbane , Queensland ) , Henrietta Marrie , formerly property systems . Fourmile ( Associate Professor , Centre for Indigenous History and 61 the Arts , University of Western Australia ; during the course of The review of The national strategy for the conservation of the Inquiry , Marrie took up a position with the Secretariat of the Australiaâ??s biological diversity ( ï쳌¤ ï쳌¥ ï쳌³ ï쳌´ ï?? ï?? ï?? ï?? ) identified as â?? not Convention on Biological Diversity , Montreal ) , Sandy McDonald achieved â?쳌 Objective ï?? . ï?? : â?? Recognize and ensure the continuity of ( Partner , McDonald and Associates , Adelaide , South Australia ) , the contribution of the ethnobiological knowledge of Australiaâ??s ï?? ï?? ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ permit would be about ï?? ï?? ï?? . ï?? ï?? ï쳌µ ï쳌³ ï쳌¤ . indigenous peoples to the conservation of Australiaâ??s biological diversity . â?쳌 The National objectives and targets for biodiversity con - 68 ï쳌¡ ï쳌© ï쳌­ ï쳌³ provided the Voumard Inquiry with a copy of the contract servation ï?? ï?? ï?? ï?? â?? ï?? ï?? ï?? ï?? ( E ï쳌® ï쳌¶ ï쳌© ï쳌² ï쳌¯ ï쳌® ï쳌­ ï쳌¥ ï쳌® ï쳌´ A ï쳌µ ï쳌³ ï쳌´ ï쳌² ï쳌¡ ï쳌¬ ï쳌© ï쳌¡ ï?? ï?? ï?? ï?? ) identified ( See http : / / www.aims.gov.au / pages / about / corporate / bsa - aims - the maintenance and recording of ethnobiological knowledge as a qldgov.html ) . A summary of the contract is presented in Box ï?? . key action to mitigate threats [ to biodiversity ] with the objective : 69 This information is based on information on BioProspectâ??s website â?? Ensure indigenous communities have access to resources to en - able them to preserve their ethnobiological knowledge about biodi - which has been removed since the website was redesigned . See versity conservation . â?쳌 The governmentâ??s ï?? ï?? ï?? ï?? election policy states also http : / / www.bioprospect.com . that it will : â?? Work with traditional Aboriginal owners to record 70 s ï?? ï?? ï쳌¥ ï쳌° ï쳌¢ ï쳌£ ï쳌¡ . indigenous knowledge and use it to inform better land management 71 Regulation ï?? ï?? . ï?? ï?? A ( ï?? ) ( f ) . procedures â?쳌 and â?? in co - operation with indigenous people , work with state and territory governments to establish mechanisms to 72 Regulation ï?? ï?? . ï?? ï?? A ( ï?? ) ( a ) and ( b ) . facilitate the inter - generational transfer of indigenous knowledge 73 Regulation ï?? ï?? . ï?? ï?? A ( ï?? ) ( c ) . and identify high priority regions for research . â?쳌 74 62 See http : / / www.wto.org / english / tratop_e / trips_e / intel ï?? _e.htm for http : / / parlinfoweb.aph.gov.au / piweb / repository / chamber / hansards / additional information about î?® î?« î?? î?© ï쳌³ . linked / ï?? ï?? ï?? ï?? - ï?? . pdf . 75 63 For further information about the law relating to the patenting of Id . 64 plants , microorganisms , and related biological materials , see ï쳌© ï쳌° http : / / www.abc.net.au / rn / talks / bbing / stories / s ï?? ï?? ï?? ï?? ï?? ï?? . htm . Australiaâ??s website at http : / / www.ipaustralia.gov.au / . ( Background Briefing : Plundering the Plants , ï?? ï?? October ï?? ï?? ï?? ï?? ) . 65 76 Government regulators in all Australian government departments , See the website of the Department of Foreign Affairs and Trade at agencies , statutory authorities , and boards are required to prepare http : / / www.dfat.gov.au / ip / biotech.html . Regulation Impact Statements ( ï쳌² ï쳌© ï쳌³ s ) . For further information about 77 The case studies are at http : / / www.wipo.int / tk / en / studies / cultural / these requirements , see http : / / www.opc.gov.au / . minding - culture / studies / finalstudy.pdf . 66 It should be noted that there does not exist a great deal of publicly 78 Australian Statement on the ï쳌© ï쳌´ ï쳌° ï쳌§ ï쳌² ï쳌¦ ï쳌¡ , Explanation of Vote , Rome , ï?? available information about these contracts . What is provided here November ï?? ï?? ï?? ï?? . is based on companies â?? submissions to the Voumard and / or Bailey 79 Inquiries and on their websites . Australian Statement on the ï쳌© ï쳌´ ï쳌° ï쳌§ ï쳌² ï쳌¦ ï쳌¡ , Explanation of Vote , Rome , ï?? 67 Paragraph ï?? ï?? . ï?? ï?? ( aa ) . At the current rate of exchange , the cost of a November ï?? ï?? ï?? ï?? . ï?? ï?? ï?? 10 Chile : Early Attempts to Develop Access and Benefit - Sharing Regulations Luis Flores - Mimiça and Dominique Hervé - Espejo Since the entry into force of the Convention on Biological failure was due , in considerable part , to the complexity of the subject and the many difficulties that the development Diversity ( ï쳌£ ï쳌¢ ï쳌¤ ) , many countries have begun to develop and implementation of such an initiative has , but overall it national biodiversity strategies and access regulations was the result of a lack of political will among legislative pursuant to the requirements in its Articles ï?? and ï?? ï?? , spe - and higher - ranked administrative authorities to consider cifically to regulate the access to genetic resources within this a matter of importance for the country . their national jurisdiction . Their experience is very valuable Given the total lack of policies and legislation on the for those countries that are just about to initiate the process . matter , in order to make an adequate analysis of the current As a part of a comparative study of the policies and laws in situation in Chile in relation to the actual exchange , han - charge of regulating the access and the exchange of genetic dling , and utilization of genetic resources and its eventual resources among Pacific Rim Countries , the main objective regulation by State authorities , throughout this paper the of this document is to review and analyze the situation of main related principles , rules , and concepts of the ï쳌£ ï쳌¢ ï쳌¤ Chile on this matter . will be used as a reference and as a means of confronting As will be explained in this document , Chile does Chilean reality . With that perspective , the paper will pres - not have any kind of specific framework for regulating ent an overview of the actual institutional management access and benefit - sharing issues , nor is it engaged in a of genetic resources in Chile , analyzing the questions serious process for developing such laws or policies . In of property , access , intellectual property rights , and bio - ï?? ï?? ï?? ï?? , shortly after Chileâ??s ratification of the ï쳌£ ï쳌¢ ï쳌¤ , there was prospecting agreements , concluding with some remarks a brief initiative to regulate this matter , prompted by the about the process of developing a regulatory framework political impact that some bioprospecting projects had on on access and benefit sharing . the environmental authorities of the time . In the long run , there were no significant results from this initiative . This Analysis of the Legal , Institutional , and Political Situation of Genetic Resources in Chile The international legal framework of access and benefit tablishing some type of legislation to regulate the access sharing established by the ï쳌£ ï쳌¢ ï쳌¤ can give countries the op - and benefit sharing of their own genetic resources and , portunity to make substantial profits from the sustainable equally important , developing political awareness , institu - utilization of their own genetic resources , through a fair tional strategies , procedures , and capacities to implement and equitable sharing of the benefits arising out of the these provisions . use of such resources . Nevertheless , national governments The regulatory system created by the ï쳌£ ï쳌¢ ï쳌¤ should also must know how to take advantage of this opportunity , es - be seen as a very useful mechanism of negotiation for ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ those countries that are providers of genetic resources , disadvantages that will , of course , be determined by the although it has to be adapted to local circumstances and particular circumstances of each country . They differ from to national interests and priorities in order to achieve its each other in a series of formal aspects that are applicable goals . The manner in which countries approach this matter to many different situations . However , all these formal and finally enact a legal regime of access to their genetic approaches can coexist without problems within the same resources will necessarily reflect the status of their eco - internal legal framework . For example , a law that regulates nomic , environmental , and technological development , as access to genetic resources ( the legal approach ) can clearly well as their legal , institutional , economic , and cultural establish that certain matters should be directly negotiated situation . There is no ideal model to be followed , because between the stakeholders , according to the rules of the each country has its own reality and is placed in a very private law ( the contractual approach ) but considering singular position . the guidelines designed by the competent authority ( the Thus , there are many alternatives by which the mecha - voluntary approach ) . nism of access and benefit sharing formulated by the ï쳌£ ï쳌¢ ï쳌¤ So far , in all those countries in which the system of can be set into practice in the particular scope of national access and benefit sharing established by ï쳌£ ï쳌¢ ï쳌¤ has not yet legislation . However , according to the regulatory experi - been implemented , private agreements have been the main ence that already exists , from a formal point of view it mechanism to regulate access to genetic resources and the would be possible to identify three basic ways to deal with way benefits are shared ( the contractual approach ) . Such the subject ( î?? î?¡ î?? î?? î?? î?? ï?? ï?? ï?? ï?? ) : is the current situation in Chile , where political authorities have not yet been able to begin a serious legislative process â?¢ The LegalApproach , through measures that involve for the implementation and enforcement of the rules and the development , implementation , and enforcement principles of the ï쳌£ ï쳌¢ ï쳌¤ , and the administrative authorities of legal , administrative , and policy provisions and do not have a legal framework nor any specific provision frameworks . National governments are able to ex - to enable them to regulate the exchange and utilization of ert their authority through a variety of alternatives : genetic resources . taking advantage of general laws on environment ; using framework laws ; developing specific laws to regulate access and distribution of benefits or The Political and Legislative Management regulating genetic resources as a singular compo - of Genetic Resources nent of legislation of broader range ; and adapting First of all , it is very important to point out that in Chile or modifying existing laws and regulations , etc . there are many endemic species ( as many in flora and â?¢ The Contractual Approach , by means of private ar - fauna as in microorganisms ) that are broadly distributed rangements or agreements directly made between in the national territory . A considerable number of these the suppliers of genetic resources and those inter - species have not yet been properly studied and remains ested in using them . These private arrangements or almost unknown ( U ï쳌® ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌¤ ï쳌¡ ï쳌¤ ï쳌¤ ï쳌¥ C ï쳌¨ ï쳌© ï쳌¬ ï쳌¥ ï?? ï?? ï?? ï?? ) . In ad - contracts are essentially legally enforceable agree - dition , in Chile there exists a considerable scientific and ments between two or more parties , consisting of technological capacity to carry out projects of research exchanges of negotiated promises or actions , set and development in the area of biotechnology , which adds under the rules of national or international private important value to Chilean genetic resources . This scien - law , generally made between stakeholders consid - tific and technological capacity is mainly placed within ering mutual benefits on access and distribution . the scope of universities and the public sector ( G ï쳌© ï쳌¬ and There are multiple contractual alternatives for 1 I ï쳌² ï쳌¡ ï쳌² ï쳌² ï?¡ ï쳌º ï쳌¡ ï쳌¢ ï쳌¡ ï쳌¬ ï?? ï?? ï?? ï?? ) . All of these factors have made Chile the exchange of genetic resources , from simple a very attractive place for bioprospecting projects . contracts to letters of understanding , licensing In spite of the above - mentioned , in Chile there has not agreements , and many others . In the case of the been a parallel institutional and legislative development , exchange of biological samples , such agreements with specific policies and laws established to regulate are usually known as Material TransferAgreements access to national genetic resources . Unfortunately , the ( ï쳌­ ï쳌´ ï쳌¡ s ) . These ï쳌­ ï쳌´ ï쳌¡ s were the first formula through complexity of the subject and the lack of political will have which the question of access to genetic resources determined the complete absence of any kind of regula - and benefit sharing was ever approached . tion . Chile does not have an official policy or a national â?¢ TheVoluntaryApproach , by means of codes of con - strategy to confront any of the multiple subject areas of the duct or voluntary guidelines , generally elaborated utilization of genetic resources . Even though the ï쳌£ ï쳌¢ ï쳌¤ is a as the result of a consensus among stakeholders or national law , the government and the political authorities developed by someone with such authority . These have not yet given much significance either to this matter regulatory instruments are not legally enforceable or to other important aspects of biological diversity . The and their fulfillment and utility depend on the good situation is such that after more than nine years Chile has will of those who are parties to the matter . just completed its National Biodiversity Strategy and has These different approaches can have advantages and initiated ( mid - ï?? ï?? ï?? ï?? ) its National Biodiverity Action Plan ï?? ï?? ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? ï?? : C ï쳌¨ ï쳌© ï쳌¬ ï쳌¥ for the conservation and sustainable use of its biological â?¢ Prevent possible conflicts between the regulations diversity , nor has it fulfilled many of the obligations ac - in force and the provisions of the international quired when it ratified the ï쳌£ ï쳌¢ ï쳌¤ . treaty and , if necessary , create a mechanism to Since the date in which the ï쳌£ ï쳌¢ ï쳌¤ finally entered solve such legal conflicts . 2 into force in Chile , the National Commission of the â?¢ Establish an institutional structure to fulfill the pre - Environment ( ï쳌£ ï쳌¯ ï쳌® ï쳌¡ ï쳌­ ï쳌¡ ) and the Ministry of Agriculture viously determined objectives and goals , unless an ( through its different departments and offices ) have been existing structure is already sufficient . the two governmental institutions mainly responsible for the implementation of the different provisions of the ï쳌£ ï쳌¢ ï쳌¤ . Finally , for a national legislative regime to be really Even though ï쳌£ ï쳌¯ ï쳌® ï쳌¡ ï쳌­ ï쳌¡ has the general institutional task suitable for implementation , besides the fulfillment of the of coordinating the action of all the public entities with minimum conditions previously indicated , a serious and environmental responsibilities , in Chile the administrative detailed assessment of the national legislation already authority that specifically manages the several components in force should be made , and a national plan , capable of national biological diversity is dispersed among a variety of covering general and specific aspects of the matter , of institutions ; in addition , these components are more should be elaborated ( with the purpose of fulfilling the often handled under the ideological conception of â?? natural particular principles and objectives of the international 3 resources â?쳌 rather than of biodiversity . Furthermore , among treaty at issue ) . the regulations related to the subject there are many cases So far , in relation to the ï쳌£ ï쳌¢ ï쳌¤ , and specifically in the of overlapping principles and provisions , which cause con - area of genetic resources , none of the above has been done siderable confusion and , in the particular circumstance in a systematic and considered way by competent Chilean of genetic resources , an almost total lack of institutional authorities . definitions . What then has been the local evolution on the subject In fact , though it could be said that the corresponding of genetic resources ? As mentioned before , shortly after articles of the ï쳌£ ï쳌¢ ï쳌¤ constitute the only legislation for access Chileâ??s ratification of the ï쳌£ ï쳌¢ ï쳌¤ , there was a significant ef - and benefit sharing that there is in Chile , it is a useless regu - fort to start a process for developing a national legislation lation , because it has not yet been properly implemented on access and benefit sharing . This initiative was mainly in the internal legal framework . This means that even conducted by the Department of Natural Resources of though the basic rules exist , they are neither applicable ï쳌£ ï쳌¯ ï쳌® ï쳌¡ ï쳌­ ï쳌¡ , which tried to coordinate the different national nor enforceable . This situation has occurred because there authorities that could eventually have some relation to are no authorities with specific responsibilities on this par - the subject . After some internal debate , a working group ticular matter nor there is a mechanism to allow the rules was created with the participation of officials of ï쳌£ ï쳌¯ ï쳌® ï쳌¡ ï쳌­ ï쳌¡ , and principles of the ï쳌£ ï쳌¢ ï쳌¤ to operate at the national level . the different departments and offices of the Ministry of So far , the only effective rules that regulate the exchange Agriculture ( Agricultural Studies and Policies Office and the utilization of genetic resources in Chile are private ( ï쳌¯ ï쳌¤ ï쳌¥ ï쳌° ï쳌¡ ) , the Agriculture and Livestock Service ( ï쳌³ ï쳌¡ ï쳌§ ) , the arrangements , made under civil law , between stakeholders , National Institute for Agriculture Research ( ï쳌© ï쳌® ï쳌© ï쳌¡ ) , and the upon whom the principles and provisions of the ï쳌£ ï쳌¢ ï쳌¤ can National Forestry Corporation ( ï쳌£ ï쳌¯ ï쳌® ï쳌¡ ï쳌¦ ) ) , and the Ministries not be legally imposed , because of the lack of competent of National Goods and Foreign Affairs . authorities and of an adequate national regulation . Besides taking the first steps to initiate the national Indeed , the implementation of an international legal debate on access and benefit sharing , one of the main instrument within a national legal regime cannot be made efforts of the governmental working group on genetic re - by the direct incorporation of its rules to the national sources was to try to identify the bioprospecting projects legislation through a simple administrative or legislative that were currently going on in Chile and interviewing act . Implementation should be a much more complex pro - those in charge of such projects . In fact , the presence of cess . In fact , the success of such a process is essentially international institutions that , directly or through national determined by the feasibility of the international rules to universities , were carrying out such initiatives in Chile actually operate in an efficient and effective way at the was one of the factors that provoked the interest of envi - internal level . On the other hand , the way in which the ronmental authorities , making them aware of the need to national implementation of international treaties takes implement the provisions of the ï쳌£ ï쳌¢ ï쳌¤ on access and benefit place is widely determined by the degree of evolution of sharing of genetic resources in Chile . the internal legal and institutional framework . To carry out In ï?? ï?? ï?? ï?? , a couple of public seminars were conducted by an effective and efficient process of implementation the in - the environmental authorities in order to generate national ternal legislative regime would , at a minimum , have to : awareness on the subject . In the same year , an administra - â?¢ Define and determine certain principles , objectives , tive agreement between the Ministry of Agriculture and priorities , and goals in relation to the matter . ï쳌© ï쳌® ï쳌© ï쳌¡ was signed , with the purpose of creating a National Program for Plant Genetic Resources . In ï?? ï?? ï?? ï?? , after an â?¢ Impose certain obligations upon the authorities and internal institutional workshop organized by ï쳌£ ï쳌¯ ï쳌® ï쳌¡ ï쳌­ ï쳌¡ and the citizens of the country in relation to the provi - sions of the international treaty at issue . the Ministry of Agriculture , a National Commission on ï?? ï?? ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ Genetic Resources was informally created . The formation â?¢ Its scope of application is limited to agricultural of this commission never had a supporting legal provision genetic resources . and its constitution was based only on an agreement among â?¢ It is a stand - alone and brief piece of legislation public officials . The work of this commission never gave which only establishes the basic framework of the any significant results . In less than a year , after two or three access system and the obligation to inform the meetings , it vanished . Ministry of any bioprospecting project . Throughout ï?? ï?? ï?? ï?? and ï?? ï?? ï?? ï?? , a couple of consultants A future proposal will therefore need further elabora - were hired by ï쳌£ ï쳌¯ ï쳌® ï쳌¡ ï쳌­ ï쳌¡ in order to analyze the national tion and the enactment of administrative regulations to legislative situation and propose ways of developing a na - determine , for example : a ) the authority that would sign tional regulation for genetic resources.After some internal the agreements in the name of the Ministry ; b ) the kind and debate , it was concluded that the only way to initiate legis - contents of the access agreements ; c ) the information re - lation capable of enabling the governmental authorities to quired ; d ) the way in which benefits will be shared , and ; e ) manage the exchange and utilization of genetic resources in Chile was by confronting the question of ownership of the way in which traditional knowledge will be protected . genetic resources , through some legislative changes in the This proposal is currently being discussed inside the gov - property regime . ernment , but there is no public discussion nor information This conclusion turned out to be the main obstacle for about when it will be sent to the National Congress . continuing with the regulating efforts of the time . This It can be argued that the original initiative to start occurred because in the Chilean Constitution the property a process of developing a national regulation for access regime gives very strong protection to private property , and benefit sharing in Chile was aborted at a very early and in order to make any kind of change to such a regime , stage . It was never based on a real national policy for bio - it would be necessary to have a special quorum in the diversity , and its beginning was essentially determined by National Congress ( ï쳌£ ï쳌¯ ï쳌® ï쳌¡ ï쳌­ ï쳌¡ ï?? ï?? ï?? ï?? ) . Some efforts were circumstantial facts , such as governmental concern about made by the relevant administrative authorities to explain bioprospecting projects going on in Chile at the time and to congressmen the importance of this subject and of its the need to fulfill the obligations acquired by Chile when regulation , in order to take the first steps in the process of ratifying the ï쳌£ ï쳌¢ ï쳌¤ . The current initiative promoted by the developing a national access and benefit - sharing frame - Ministry of Agriculture lacks the support of a national work . Unfortunately , the issue was not really understood policy for biodiversity which would allow the discussion and the political authorities of the country never considered and adoption of a regulation on this matter based on a seri - it important . ous commitment of the government and a broad acceptance By the end of ï?? ï?? ï?? ï?? , most of the officials who were by the different stakeholders . originally actively involved in this process had left their Finally , concerning the ï쳌¦ ï쳌¡ ï쳌¯ International Treaty on positions in the public sector , and the current political Plant Genetic Resources , in March ï?? ï?? ï?? ï?? the Ministry of and administrative authorities were not worried about Agriculture started a process of consultation and analysis bioprospecting projects going on in Chile anymore . So , within the public sector , in order to determine the conse - the process started to lose the momentum it had previ - quences and benefits that signature and ratification may ously had . have for Chile . After a few months of discussions Chile Since ï?? ï?? ï?? ï?? , ï쳌£ ï쳌¯ ï쳌® ï쳌¡ ï쳌­ ï쳌¡ had not been directly involved signed the ï쳌¦ ï쳌¡ ï쳌¯ Treaty on ï?? November ï?? ï?? ï?? ï?? . in any significant activity related to this subject until the end of ï?? ï?? ï?? ï?? , when the issue was considered again by the The Ownership of Genetic Resources 4 Department of Natural Resources . At the Ministry of The ï쳌£ ï쳌¢ ï쳌¤ makes no reference to ownership of land or Agriculture , efforts on the subject continue , on a much genetic resources , dealing only with access to genetic smaller scale ; they are mainly carried out by ï쳌¯ ï쳌¤ ï쳌¥ ï쳌° ï쳌¡ , but resources and sovereign rights over natural resources . the political importance originally assigned to this matter Questions of ownership and tenure inevitably have an by the Ministry has been lost . Nevertheless , the Ministry important bearing on the practicalities of bioprospecting is the only authority that has been permanently working and are an important element of national legislation and on this issue by studying a way to solve the legislative policy that governments can use to â?? determine access â?쳌 to obstacles related to ownership of genetic resources and by resources , yet they are often overlooked by policy - makers . developing a ministerial policy regarding the protection Users of genetic resources must be sure that the supplier and economical valuation of national genetic resources has the authority to collect and provide such resources , or ( A ï쳌§ ï?¼ ï쳌¥ ï쳌² ï쳌¯ ï?? ï?? ï?? ï?? ) . In late ï?? ï?? ï?? ï?? , the Ministry completed the ï쳌£ ï쳌¢ ï쳌¤ requirements would not be fulfilled . Such author - a first draft of a legislative proposal regarding access to ity may rest not only with the government but also with and sharing of benefits derived from agricultural genetic those who have private rights or tenure over the land or resources , but it was discarded after being criticized by resources . Because of this , at a certain point , governmental some sectors . However , since efforts to develop a better authorities may have to clarify the relationship between proposal continues , it is important to discuss some of its main elements which are : the ownership , tenure , and access regimes . ï?? ï?? ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? ï?? : C ï쳌¨ ï쳌© ï쳌¬ ï쳌¥ ï쳌² The international recognition of sovereign rights over tion of genetic resources , it is necessary to identify the legal genetic resources within national territory constitutes the provisions that , directly or indirectly , regulate the subject . foundation and the theoretical framework over which each The only definition of genetic resources that exists in the State has the responsibility to specify its own legal regime , Chilean legal regime is in Article ï?? of the ï쳌£ ï쳌¢ ï쳌¤ , which , in in order to establish concrete and specific rights , over con - the absence of any other legal provision , determines the crete and specific resources . This international recognition conceptual framework of the regulated object . With regard only means that the State , by virtue of its sovereignty , has to attributing ownership or tenure to genetic resources , it the legitimate right to â?? define and determine â?쳌 the type and is necessary , in the first place , to identify and analyze the the modalities of property that are recognized , according general provisions of the property regime in the national to the principles and rules of its internal legal framework legal framework and then to check if they are applicable and in harmony with the international commitments that it to the objects that are legally conceptualized as genetic has acquired . As with the legal framework for access , the resources . If there is not such an express provision by ex - different possibilities through which the sovereign power tension the applicable provisions will be those that regulate of a State can determine the property regime for genetic the property of the biological resources which contain the 5 resources are multiple and diverse . genetic resources ( ï쳌£ ï쳌¯ ï쳌® ï쳌¡ ï쳌­ ï쳌¡ ï?? ï?? ï?? ï?? ) . In order to enact and implement a particular legisla - The Political Constitution of the Republic lacks all tion , one of the first tasks is to define the object that will explicit reference to biological diversity or some of its be regulated and the ownership of the rights attributable to elements ; neither does it refer to it through other con - this object , particularly property rights . The determination cepts , such as flora and fauna or plants and animals . It of a specific property regime requires a clear identifica - only alludes indirectly to these realities , when imposing tion of the goods to which it refers and of the rules and on the State the constitutional duty of â?? maintaining for principles according to which it will be structured . In the the preservation of nature â?쳌 , when determining that by case of genetic resources , this subject is new , extremely law it will be possible to establish specific restrictions complex , and , in most countries , has still not been seri - on the exercise of certain rights or liberties in order to ously confronted . â?? protect the environment â?쳌 ( Article ï?? ï?? , Number ï?? ) ; and Today , private property prevails in the majority of the when indicating that a fundamental concept of the social legal systems of the world . However , there are certain function of property is â?? the conservation of the environ - resources that are considered of such value for national mental patrimony â?쳌 ( Article ï?? ï?? , Number ï?? ï?? ) . In addition , interests that its ownership is left in the hands of the State . the Constitution establishes â?? the freedom to acquire the Other resources , however , are placed under the regime ownership of all types of goods â?쳌 , with the single excep - of private property and will belong to individuals or to tion of â?? those that nature has made common to all men or the State , according to the rules and principles of the ap - should belong to the Nation and that the legislation has plicable legislation . Thus , nations usually retain certain thus declared â?쳌 ( Article ï?? ï?? , Number ï?? ï?? ) . This provision , goods under their control as public property ( for example , besides being a constitutional guarantee , establishes the in some countries mining resources are State - owned ) and , freedom to acquire all types of goods as the general rule in addition , they may maintain ownership of some goods of the Chilean legal property regime . Under this provi - as private property . Public property can be declared with sion , the possibility of acquiring property of any type of respect to individualized and quantified goods , or with biological resource is totally granted ( in conformity with respect to an undetermined amount of resources belonging the provisions of the Civil Law on goods and acquisition to a certain category . Such is the case , for example , in the of ownership ) , unless a Law of Higher Quorum , when it public property established over waters or oil reserves . is demanded by the national interest , establishes special Considering all that has been already said , it must be requirements or limitations to the acquisition of the owner - held in mind that both the definition and the implementa - ship of such goods . tion of a property regime ( public or private ) or other types The Constitution sets forth general rules for struc - of rights , in relation to genetic resources , are limited by the turing the national property regime , but it is the lawâ??s intrinsic nature of such resources . For any property regime responsibility to specify the particular regime of property on such resources to be effective , the subject to which it applicable to specific goods and to establish the ways to refers and the type of rights that are going to be granted acquire ownership . Therefore , it is necessary to review the must be defined in a suitable way . In the first place , it is pertinent provisions of the Civil Law . necessary to establish a distinction between rights on the The few references in the Civil Code to biological physical entities ( the physical property or plant - animal ) resources are made according to obsolete conceptual cat - and the eventual rights on the genetic information con - egories that have nothing to do with biological diversity . In tained in such entities ( intangible property ) . The real value relation to those biological resources that can be included of genetic resources lies in the second element , and the in the concept of fauna , the Civil Code establishes that legal questions that arise in relation to it are particularly domestic animals are linked to the land they serve and that complex . wild fauna such as fish , birds , and others are considered 6 In order to know how Chile interprets the legal defini - freely acquirable goods , in the condition of res nullius . In ï?? ï?? ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ relation to those biological resources that can be included In addition , an analysis of the provisions charged in the concept of flora , the Civil Code considers that they with attributing competencies and establishing rules for follow the ownership of the land in which they are located . access will allow the identification of interests and objec - Given the fact that under the Chilean property regime there tives of an eventual national policy regarding the matter are no lands without an owner , the different biological in question . resources associated with flora will be the property of As noted before , under current legislation Chile does the individual owners of the respective land or , in their not have a regulation directly establishing the competent absence , of the State of Chile . In relation to microorgan - authority regarding access to genetic resources . Indeed , isms ( fundamental raw material of the biotechnological genetic resources are not treated as such by any law , apart industry ) , national legislation has not established any type from the mandates established by the ï쳌£ ï쳌¢ ï쳌¤ . Nevertheless , of provision for regulating their ownership regime . taking into account the legal framework applicable to This is the general legal framework that regulates the biological resources , there are several public institutions property of biological resources in Chile . There are other that could potentially serve as the competent authority laws and regulations that deal with questions relative to the regarding certain aspects related to access . These are : â?? handling â?쳌 of biological resources , but they do not alter the Ministry of Agriculture ( through ï쳌© ï쳌® ï쳌© ï쳌¡ , ï쳌£ ï쳌¯ ï쳌® ï쳌¡ ï쳌¦ , ï쳌³ ï쳌¡ ï쳌§ , or modify the general regime of property established by and ï쳌¯ ï쳌¤ ï쳌¥ ï쳌° ï쳌¡ ) ; the Ministry of Economy ( through the 7 the provisions described before . Fishing Undersecretariat , the National Fishing Board Evidently , in Chileâ??s legal framework on property there ( ï쳌³ ï쳌¥ ï쳌² ï쳌® ï쳌¡ ï쳌° ï쳌¥ ï쳌³ ï쳌£ ï쳌¡ ) ; and the Forestry Institute ) ; the Ministry of is no particular and differentiated regime to regulate the National Goods ; the National Commission on Scientific question of ownership of genetic resources . Genetic re - and Technological Research ; ï쳌£ ï쳌¯ ï쳌® ï쳌¡ ï쳌­ ï쳌¡ ; and the National sources constitute a new legal object , still not recognized Corporation on Indigenous Development ( ï쳌£ ï쳌¯ ï쳌® ï쳌¡ ï쳌¤ ï쳌© ) . by the legislature , and their ownership is not specifically Chile does not have any authorities with a specific and regulated by any particular regime . Therefore , we can as - exclusive competency in genetic resources ; nor does it sume that , considering the nature of genetic material and have any particular regulation concerning access to such the legal principle indicating that the accessory follows resources . In practice , as is the case of property , the only the principal or main thing , in Chile genetic resources are mechanism that might come near to fulfilling such a role placed under the property regime applicable to biological are the legal provisions charged with regulating access to resources , such as animals and plants . biological resources . Access to biological resources found in fauna The Regime of Access to Genetic and Chileâ??s legal structures generally define the components of Biological Resources fauna as res nullius , that is , as a good that does not belong to anyone . This legal situation allows the state to establish , The ratification of the ï쳌£ ï쳌¢ ï쳌¤ brings with it obligations that via the corresponding mechanisms , certain restrictions to can be difficult to implement and that require profound the access to these biological resources . In order to review changes in the internal legal framework . Article ï?? ï?? of the mechanisms we will distinguish between nonwild the ï쳌£ ï쳌¢ ï쳌¤ defines the obligations and rights of the Member fauna , wild fauna , and hydrobiological species . Parties with respect to access to genetic resources and their Access to faunal biological resources not included in subsequent use . These obligations and rights are based on the wild fauna category only requires the authorization of the following principles and fundamental rules : the owner of the land and specimen . In contrast access to â?¢ National sovereignty over genetic resources and , biological resources found in wild fauna species , where as a consequence , the full authority of national such access necessarily requires the species â?? capture or jurisdiction to regulate access to such resources ; hunt , will always need , in accordance with the Hunting â?¢ Access to resources subject to the prior informed 8 Law , a hunting permit or license . . This permit or license consent of the supplying nations ; and is also required for owners of estates where hunted animals â?¢ Access to resources subject to mutually agreed are found . Since the law states that ownership of biologi - terms and conditions that will define , in a concrete cal resources is not granted through the use of wild fauna and specific way , the manner in which the sharing species nor of its products , by - products , or parts if this is of the benefits will be carried out . carried out by transgressing the regulations of the law or its jurisdiction , the permit or license may be particularly Two issues are basic for the development and imple - 9 relevant . Hunting permission is granted by ï쳌³ ï쳌¡ ï쳌§ . A hunt - mentation of a system of access in Chile : ing permit allows the bearer to hunt big or small game as â?¢ Determining the competent authority or authorities indicated . Granting permission is subject to passing an in charge of access to domestic genetic resources exam and payment of a fee . ( competent national authority ) , and , secondly , However , there are certain cases in which hunting or capture is prohibited or restricted . This potentially contro - â?¢ Identifying the provisions regulating the way in which the access procedure should be carried out . versial situation also implies the prohibition or restriction ï?? ï?? ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? ï?? : C ï쳌¨ ï쳌© ï쳌¬ ï쳌¥ of access to the corresponding genetic resources . The fol - Regarding the regulation of access to biological resources found in hydrobiological species , we should lowing is a brief description of such cases : essentially consider the rules established by the General â?¢ Hunting or capturing is prohibited in areas which Fishing and Aquaculture Law which regulate the proce - 10 constitute protected zones or other special zones . dure of access to these resources in reference to fishing Regardless of the latter , ï쳌³ ï쳌¡ ï쳌§ may give authorization for extraction and research . for scientific aims , such as controlling the activities Extractive fishing activity may be industrial or tra - of animals that cause serious damage to the ecosys - ditional . Regarding the former , the law establishes a tem , establishing reproduction or breeding centers , general mechanism and a special mechanism of access or allowing the sustainable use of a resource . to resources that apply to Chilean Territorial Sea and â?¢ Hunting or capturing species in danger of extinc - Exclusive Economic Zone , with the exception of areas tion or vulnerable , rare and scarcely known species reserved exclusively for traditional fishing . The general is prohibited , as is hunting or capturing species mechanism of access to industrial extractive fishing means regarded as beneficial to forestry , fishing , and that persons interested in carrying out industrial fishing agricultural sciences , or to the maintenance of the must request a fishing permit for each vessel . This permit equilibrium of natural ecosystems , or species with is granted for an unlimited period of time according to reduced population densities . Regardless of the the species and zones outlined . On the other hand , there latter , ï쳌³ ï쳌¡ ï쳌§ may authorize such hunting or capture are special access mechanisms applicable in the case of when the authorized party proves that hunting or resources which are currently being fully exploited and in capturing of specimens is necessary for research , which fishing systems are in recovery or just starting . For for the creation of reproduction or breeding cen - every fishing unit declared to be in any one of those states , ters , for the sustainable use of a resource , or for a management plan must be developed which must outline , controlling the activities of animals that cause among other elements , the means of conservation and ac - serious damage to the ecosystem . In any case , the cess mechanisms which apply in the particular case . corresponding authorization should indicate the For traditional fishing the access mechanism is that of prevalence of the species , the maximum number freedom to fish . However , in order to carry out their activ - and type of specimens whose hunting or capture is ity , traditional fishermen and their vessels must previously being authorized , and any other conditions under register with the registry coordinated by ï쳌³ ï쳌¥ ï쳌² ï쳌® ï쳌¡ ï쳌° ï쳌¥ ï쳌³ ï쳌£ ï쳌¡ . In which the extraction will take place . any case , with the aim of protecting hydrobiological re - â?¢ For species not included in the above cases , the sources , granting permits may be temporarily suspended law establishes hunting and capturing seasons and ( by traditional fishermen category or by fishing company ) areas , as well as the number of specimens that may when one or more species becomes fully exploited . be hunted or captured per day , season , or age group . Regarding research fishing , the law determines The only exceptions to these restrictions are certain whether the species and areas are subject to a general species of wild fauna which are considered harm - or special access mechanism . In either case , the Fishing ful and which may thus be hunted or captured at Undersecretariat is responsible for authorizing the capture any time of year , throughout Chilean territory and of corresponding hydrobiological species according to the regardless of quantity or specimens . However , a approved research project . In the case of special mecha - hunting permission or license is still required for nisms , global quotas , if they exist , must be obeyed . these species . Certain mandates also exist that allow restrictions on â?¢ On the other hand , the international trade and access to hydrobiological species with the aim of protect - transportation of wild fauna species must be carried ing and preserving the species . These mandates refer to the out according to the provisions established by the establishment of prohibition periods ( biological , extractive , Convention on International Trade of Endangered or extraordinary ) ; to the temporary or permanent prohibi - Species ( ï쳌£ ï쳌© ï쳌´ ï쳌¥ ï쳌³ ) . This international treaty aims to tion of capture of hydrobiological resources protected by regulate the trade and transportation of wild ani - international treaties in force in Chile ; to the establishment mals and plants considered to be in danger or threat of marine parks and reserves ; and to the fixing of annual of extinction . This regulation not only encompasses quotas of capture by species in a defined area . live flora and fauna species but also includes all their Lastly , regarding the regulation of access to biological derivatives and by - products ( stuffed animals , furs , resources found in fauna in general , the restrictions on the bones , tissue samples , pharmaceutical products , capture of determined species set out by international trea - etc . ) . Although this Convention refers only to the ties signed by Chile must also be considered.Among these protection of species and not to genetic diversities , we highlight the following : the International Agreement its provisions constitute , in practice , an eventual for the Regulation of Whaling ( ï?? ï?? ï?? ï?? ) , the Convention for requirement to be met in the case of international the Conservation ofAntarctic Seals ( ï?? ï?? ï?? ï?? ) , the Convention trading of a genetic resource contained in any one on Wetlands which is of international importance specially of the species included in the treaty . regarding the habitat of waterfowl , the Convention on the ï?? ï?? ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ Conservation of Migratory Species of Wild Animals With such few mandates in mind , it can be concluded ( ï?? ï?? ï?? ï?? ) , and the Convention for the Conservation and that Chileâ??s legal framework does not expressly regulate Management of the Vicuña ( ï?? ï?? ï?? ï?? ) , all in force in Chile . access to plant material . Indeed , there is a huge imbalance By virtue of the above mentioned regulations we may in the regulation of access between floral and faunal bio - conclude that access to biological resources found in fauna logical resources ( I ï쳌² ï쳌© ï쳌¡ ï쳌² ï쳌´ ï쳌¥ ï?? ï?? ï?? ï?? ) . Regarding this , the cur - is quite exhaustively regulated in Chile . The only excep - rent legislation on the matter of protected areas is of great tions are land invertebrates which have not been included relevance , as are the requirements that define the access to in the mentioned provisions . these areas , because both are indirectly applicable to the plant material found in them . This legislation is composed Access to biological resources found in flora of the following legal texts : the Supreme Decree No . ï?? ï?? ï?? , Flora , in general , is considered by Chileâ??s legal structure ï?? ï?? ï?? ï?? , approved by the Convention for the Protection of the as a property that is defined by the fact that it is rooted Flora , the Fauna and the Natural Scenic Beauties of the to the ground ; it thus belongs to the owner of the land in Countries ofAmerica ( Washington ï?? ï?? ï?? ï?? Convention ) ; Law 11 which it is found . This legal situation prevents the state No . ï?? ï?? . ï?? ï?? ï?? , the National Monuments Law ; Decree Law from establishing , in general terms , restrictions upon these No . ï?? ï?? ï?? ï?? , on Purchase , Administration , and Disposition biological resources . Regardless of this , Chileâ??s legislation of State Goods ; Supreme Decree No . ï?? ï?? ï?? ï?? the Forestry has a variety of laws and policies that regulate , particularly Law ; Law No . ï?? ï?? . ï?? ï?? ï?? , that establishes Protected Areas for certain cases , access to the biological resources found for Tourism ; Law No . ï?? ï?? . ï?? ï?? ï?? , that creates a National in Chilean flora . 14 System of Wild Areas Protected by the State ; and the In the first place , it is relevant to refer to the mandates Environmental Framework Law No . ï?? ï?? . ï?? ï?? ï?? . According directly related to the collection of plant material . The to these laws , the following main categories of protected Forestry Law constitutes the first legal framework that wild areas exist : regulates this aspect . The following are prohibited by National Park : A generally extensive zone , where di - Article ï?? : verse environments that are unique or that are representa - â?¢ Cutting down of native trees and shrubs located less tive of the countryâ??s natural ecological diversity are found . than ï?? ï?? ï?? meters from fresh waters that spring from These are not significantly altered by human action , are the hills and less than ï?? ï?? ï?? meters from water banks capable of self - perpetuation , and their flora , fauna , and from the point at which the fresh water arises until geological formations are of special interest for scientific , it reaches level ground ; educational , or recreational reasons . The objectives of this category are the preservation of our natural environments â?¢ Cutting down or destruction of woods located within with the cultural and scenic characteristics that are associ - a ï?? ï?? ï?? meter radius of water supplies that originate ated with them ; the continuity of evolutionary processes , in plain terrains that are not watered ; and and , whenever compatible to the aforementioned , research , â?¢ Cutting down or exploitation of native trees and educational , and recreational activities . The national parks shrubs located on land that slopes over ï?? ï?? % . constitute fiscal property , although some parks are partially owned by private organizations . This category of protected Regardless of the latter , cutting down in such sectors areas is constituted by Supreme Mandate of the Ministries may be possible when duly justified and with previous of Agriculture and National Goods . ï쳌£ ï쳌¯ ï쳌® ï쳌¡ ï쳌¦ authorizes the approval of an operating plan in conformity with Decree operating plans of the activities that are carried out inside Law No . ï?? ï?? ï?? , ï?? ï?? ï?? ï?? . each protected zone . This mandate allows restriction of access to the biologi - Forest ( or National ) Reserve : An area whose natural cal resources contained in Chilean tree and shrub species , resources need particularly careful conservation and use especially in specific in cases which Chileâ??s legislature because of its susceptibility to degradation or its relevance considers the species in need of protection . Nevertheless , 12 to the communityâ??s well being . The aim of this category this is not an absolute prohibition since ï쳌£ ï쳌¯ ï쳌® ï쳌¡ ï쳌¦ can ex - is the conservation of soil and water of threatened species pressly authorize this collection on â?? justified grounds â?쳌 . of wild fauna and flora , the maintenance or improvement On the other hand , the Decree Law No . ï?? ï?? ï?? on Forestry of water production , and the development and applica - Promotion also indirectly regulates the cutting of forests tion of efficient technologies of advantage to flora and and plant material , by establishing incentives for the sub - fauna . A regulated intervention is allowed in these areas stitution of forest plantations . Another law , Decree Law and it is therefore possible to give concessions and ap - No . ï?? ï?? ï?? ï?? , ( The Agricultural Protection Law ) , establishes prove operating plans in them . Nevertheless , in practice certain mandates in relation to exportation of plant prod - 13 handling plans for forest exploitation are only granted to ucts , requiring a sanitary certificate issued by ï쳌³ ï쳌¡ ï쳌§ , thus fiscal entities . They are constituted by Supreme Mandate restricting the international transference of plant material . of the Ministry of Agriculture and their administration is Finally , regarding the commerce and international trans - also a responsibility of ï쳌£ ï쳌¯ ï쳌® ï쳌¡ ï쳌¦ . portation of wild flora species , the mandates that can be National Monument:A generally reduced area , charac - applied are those agreed upon by ï쳌£ ï쳌© ï쳌´ ï쳌¥ ï쳌³ , which has been discussed above with regard to wild fauna . terized by the presence of native species of flora and fauna ï?? ï?? ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? ï?? : C ï쳌¨ ï쳌© ï쳌¬ ï쳌¥ or by the existence of geological sites that are relevant ing biological resources have specific objectives that are different from those established by the ï쳌£ ï쳌¢ ï쳌¤ â?? s system of from a scenic , cultural , educational , or research point of access to genetic resources . view . The aim of this category is the preservation of natural environmental samples and associated scenic and cultural characteristics and , whenever compatible , research , educa - The National Program for the Protection of tional , or recreational activities . National Monuments have Plant Genetic Resources the same characteristics as national parks but are smaller In Chilean institutional practice , ï쳌© ï쳌® ï쳌© ï쳌¡ is the only public areas or defined objects ( e.g . , the Araucaria and Alerce sector institution that has actively dealt with the issue of trees ) . They are also constituted by Supreme Mandate of conservation and utilization of genetic resources ( specifi - the Ministry of Agriculture and ï쳌£ ï쳌¯ ï쳌® ï쳌¡ ï쳌¦ is responsible for cally plant genetic resources ) . This has been done through their administration . a Program on Plant Genetic Resources , with the general Natural Sanctuary : Land or sea areas whose natural objective of looking after the preservation and distribution resources are so relevant that they offer special possibilities of both Chilean and foreign germplasm , and of trying to for scientific research . These areas are created by Supreme increase its availability for future generations ( C ï쳌µ ï쳌¢ ï쳌© ï쳌¬ ï쳌¬ ï쳌¯ ï쳌³ Mandate of the Ministry of Education ( Council of National and L ï쳌¥ ï?³ ï쳌® ï?? ï?? ï?? ï?? ) . Monuments ) and in practice they are nearly all privately With the aim of obtaining official support for this owned lands . These areas allow forest exploitation under Program of Development and Protection of the Countryâ??s approval of an operating plan . In conformity with the Plant Genetic Resources , ï쳌© ï쳌® ï쳌© ï쳌¡ and the Ministry of National Monuments Law , all activities carried out in a Agriculture signed an agreement on ï?? August ï?? ï?? ï?? ï?? . Sanctuary need approval from the Council of National According to the agreement , the general objective of this Monuments . program is to safeguard the preservation and interchange Protected Areas for Tourism : Areas comprised of pri - of germplasm of wild plant species and those improved vate land of great scenic and tourist value in which ï쳌£ ï쳌¯ ï쳌® ï쳌¡ ï쳌¦ and obtained by the State . Its specific objectives are the regulates the cutting of trees and undertakes measures to following : protect natural resources . These areas are created by â?¢ Avoid loss and promote better use of Chileâ??s plant Supreme Mandate of the Ministry of Agriculture . genetic material . Furthermore , according to Law No . ï?? ï?? . ï?? ï?? ï?? , all works , â?¢ Support and coordinate work on genetic resources programs , or activities to be carried out must be submit - carried out in Chile and other countries promoting ted to the Environmental Impact Assessment System , national and international collaboration . coordinated by ï쳌£ ï쳌¯ ï쳌® ï쳌¡ ï쳌­ ï쳌¡ . This applies to national parks , national reserves , natural monuments , virgin area reserves , â?¢ Generate , with the use of Chileâ??s plant genetic re - natural sanctuaries , marine parks , marine reserves , or any sources , new crops or variants , to be incorporated other areas under official protection , when the respective into the national production . legislation so permits . Thus to be able to carry out any â?¢ Establish and operate germplasm banks . activity in a protected area , including access to the bio - â?¢ Propose to the Ministry policies for the handling logical resources found in it , an authorization from the and interchange of germplasm . appropriate authority and the corresponding environmental The actions carried out by the program are the fol - qualification is required . lowing : Finally , it is also important to mention the mandates 15 â?¢ Exploration and collection : The agreement es - established by Indigenous Law No . ï?? ï?? . ï?? ï?? ï?? , in which ar - tablishes that ï쳌© ï쳌® ï쳌© ï쳌¡ must verify that all explorations ticle No . ï?? ï?? refers to indigenous participation . It declares or collections of plant genetic resources that are that state administrative services and organizations that state property must be carried out according to the deal with territorial matters must take into account the following requirements : opinion of the indigenous organizations acknowledged by â?? A request for exploration or collection must be this law when considering topics related to indigenous is - made with tentative plans for the field mission , sues . Likewise , Article ï?? ï?? states that the administration of including the types of materials to be collected , protected wild areas that are in the indigenous development their species and quantities , and the subsequent zones must include the participation of its communities . evaluation , storage , and use . Also , required is a ï쳌£ ï쳌¯ ï쳌® ï쳌¡ ï쳌¦ or ï쳌³ ï쳌¡ ï쳌§ and ï쳌£ ï쳌¯ ï쳌® ï쳌¡ ï쳌¤ ï쳌© will decide the manner and description of the distribution of the germplasm depth of participation on the rights of use of the area that that will be carried out and the information that correspond to the indigenous communities . those in charge of collection must present once In conclusion , the current procedures in Chile regard - the mission has finished . ing access to biological resources do not meet the main objective of the ï쳌£ ï쳌¢ ï쳌¤ with respect to the regulation of ac - â?? The exploration or collection must be carried cess to genetic resources : that is , the fair and equitable out with the participation of national equiva - sharing of the benefits resulting from its use . Indeed , the lents designated by ï쳌© ï쳌® ï쳌© ï쳌¡ and paid for by the procedures that we have taken into consideration regard - collectors . ï?? ï?? ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ established regulations ; and certify compliance â?? The Ministry of Agriculture can forbid the with the regulations established by the Program collection of certain species and establish for export of genetic material . areas where collection cannot be carried out . Likewise , it can establish the types , origin , and 21 â?¢ Introduction of germplasm into Chile : All intern - quantities that must be deposited in Chile . ment of germplasm for ï쳌© ï쳌® ï쳌© ï쳌¡ must be backed by a â?? Priority is given to requests of exploration or sanitary plant certificate issued by the organization collection by the classification of species , as officially in charge of plant sanitation in the country follows : native - grown species ; native species of of origin , and the germplasm must be submitted to a potential interest ; naturalized foreign species ; quarantine post - entry measures required by ï쳌³ ï쳌¡ ï쳌§ . species long introduced but that have not been In compliance with this Program , in past years ï쳌© ï쳌® ï쳌© ï쳌¡ has collected or that have a low representation in subscribed to different bioprospecting agreements under the countryâ??s collections ; ancestral species of a contractual approach , trying to follow the rules of the cultivated species ; and wild species related to ï쳌£ ï쳌¢ ï쳌¤ . Nevertheless , being only a research entity , ï쳌© ï쳌® ï쳌© ï쳌¡ does cultivated species . not have any institutional authority over national plant â?¢ Documentation , characterization , and evaluation genetic resources nor has it any regulatory authority at 16 of the resource : Adequate information on the all . So it cannot be said that these agreements are part of collected resources must be obtained ( botanical public policy or regulation on the matter . descriptors and physiological , genetic , agronomic , industrial , and biochemical characteristics ) in co - Intellectual Property Rights and Genetic ordination with specialized personnel evaluating Resources and characterizing the germplasm . 17 â?¢ Conservation : ï쳌© ï쳌® ï쳌© ï쳌¡ must use germplasm banks The intellectual property protection system currently in as its genetic resource conservation system with a force in Chile has two different formulas that apply to basic collection and , when appropriate , an active inventions related to biological resources . These are pat - collection , of each stored species . ents , regulated by Law No . ï?? ï?? . ï?? ï?? ï?? , ï?? ï?? ï?? ï?? , and breeders â?? 18 â?¢ Information and distribution of genetic resources : rights , regulated by Law No . ï?? ï?? . ï?? ï?? ï?? , ï?? ï?? ï?? ï?? . Both formulas ï쳌© ï쳌® ï쳌© ï쳌¡ will publish periodically updated catalogues have different scopes and structures . The breeders â?? rights of the genetic material stored in their banks . This system only applies to plant varieties , which are expressly material will be grouped in three distribution cat - excluded from the patent system . egories : free , restricted , and prohibited distribution . Regarding the awarding of a patent and the consequent This classification is based on the desire to maintain protection given to biotechnological innovations ( products a policy of reciprocity between research organiza - or procedures ) , the current legislation expressly excludes 22 tions and as well as the need to keep material that only the patenting of plant varieties and animal species . clearly represents a competitive advantage in the Therefore , according to the tenor of Article ï?? ï?? of the context of international commerce . Until now , Regulation of Law No . ï?? ï?? . ï?? ï?? ï?? â?? inventions related to bio - ï쳌© ï쳌® ï쳌© ï쳌¡ has not classified any genetic resource in the technological procedures and products that either consist prohibited distribution category . of life material or contain it â?쳌 can be patented . This allows 19 the patenting of inventions carried out on genetic material , â?¢ National guardian of plant genetic resources : ï쳌© ï쳌® ï쳌© ï쳌¡ 20 but the patent must refer to an invention , not a discovery , acts as National Guardian of Chileâ??s plant genetic and the requirements stipulated by Law No . ï?? ï?? . ï?? ï?? ï?? and resources , with the responsibility to define and its regulation must be complied with . determine priorities regarding the existing species Given that inventions based on plant varieties and as - in Chile that are considered as genetic resources ; sociated biological material ( mainly seeds ) are not covered verify compliance with the general regulations es - by patent protection , they may be subject to protection tablished by the Ministry of Agriculture regarding via the breeders â?? rights mechanisms , as stipulated in the the conditions under which the explorations and International Union for the Protection of New Varieties collections of Chileâ??s genetic resources will be car - of Plants ( ï쳌µ ï쳌° ï쳌¯ ï쳌¶ ) treaty and Law No . ï?? ï?? . ï?? ï?? ï?? . Thus , plant ried out ; conserve in the germplasm Bank System varieties can be subject only to breeders â?? rights , but inven - samples of genetic resources entrusted by the state tions based on biological material of plant origin ( that are or left in custody by private entities ; define the con - not included in the concept of variety ) may be protected ditions that must be complied with when depositing either by the breeders â?? rights system ( indirectly , since the in the germplasm Bank System ; carry out follow - up protection includes the variety of which it forms a part ) or and monitoring of the deposited samples ; multiply by the patent system ( directly , on any innovation ) . and regenerate the deposited samples ; document Regarding animals , there is no special legislation in and report the existence of genetic resources con - Chile that contemplates a specific protection system , as served in the system ; distribute and use the genetic resources that are entrusted by the state under the with plant varieties . Nevertheless , material of animal origin ï?? ï?? ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? ï?? : C ï쳌¨ ï쳌© ï쳌¬ ï쳌¥ can be protected by means of the patent system , as long Privileges and Protection of the Rights of Industrial as the stipulations and requisites of Law No . ï?? ï?? . ï?? ï?? ï?? and Property , was submitted for consideration in the Chilean its regulation are complied with . Chamber of Deputies . The aim of the Bill is â?? the execu - In the case of microorganisms , cellular composites , and tion of obligations that , in matters of industrial property , other biological classifications , apart from those indicated were adopted by the Chilean State within the framework by Article ï?? ï?? of the regulation of Law No . ï?? ï?? . ï?? ï?? ï?? , there of the Marrakech Agreement , modifying Law No . ï?? ï?? . ï?? ï?? ï?? is no provision that , directly or indirectly , refers to their in conformity with the stipulations established in that in - inclusion or exclusion from the patent system . Given the ternational legislative body â?쳌 . Likewise , this Bill introduces fact that patentability is the general rule of the system and some modifications to current laws that are destined to considering the reference toArticle ï?? ï?? , it can be concluded complete and comply with the Paris Agreement ( in force that the aforementioned materials may be the object of in Chile since ï?? ï?? ï?? ï?? ) . patent protection , if and when the respective inventions Regarding the modifications proposed for the patents comply with the requisites stipulated by Law No . ï?? ï?? . ï?? ï?? ï?? system , the main changes are related to the period of pro - and its regulation . tection of the rights conferred by the patent ( it increases Since the legislation that regulates patents has a gen - from ï?? ï?? to ï?? ï?? years ) and the procedural aspects for the eral rule of broad patentability , alongside the mandates of granting of this right . Specifically , in relation to the pat - Article ï?? ï?? , the possibility to patent all kinds of inventions entability of different forms of life , the Bill reproduces , based on diverse biological resources exists . Nevertheless , nearly identically , Article ï?? ï?? . ï?? . b of the Agreement on it is important to note that this is only a possibility and does Trade - Related Aspects of Intellectual Property Rights . not imply a systematic patenting of forms of life.Although Thus Article ï?? ï?? of Law No . ï?? ï?? . ï?? ï?? ï?? would indicate the the possibility exists , the system enacted in the respective following : legislation was not elaborated with such cases in mind , The following will not be considered as an invention and , for now , does not have the necessary structure and and will remain excluded from the patent protection of institutionalization to handle the complexity surrounding this legislation : b ) Plants and animals , excluding micro - the attribution of intellectual property rights over different organisms , and essential biological procedures for the life forms . It is the responsibility of the qualified institu - production of plants or animals , that are not biological or microbiological procedures . The plant varieties will tion ( Department of Industrial Property of the Ministry of benefit from protection whenever they can stay within Economy ) to determine the extent of the protection granted the boundaries of the mandates of Law No . ï?? ï?? . ï?? ï?? ï?? on to the patent system of Law No . ï?? ï?? . ï?? ï?? ï?? . breeders â?? rights of new plant varieties . Beyond the possibility of patenting inventions carried out on live material , it is fundamental to define a national To illustrate some aspects of this incipient discussion policy on the subject of intellectual property and its scope . in Chile on this matter , we will refer to the most relevant A harmonious regulation can be established , with clear suggestions that have been formulated during the discus - and efficient rules , founded on objectives relevant to na - sion of this proposal in Congress ( C ï쳌¡ ï쳌­ ï쳌¡ ï쳌² ï쳌¡ ï쳌¤ ï쳌¥ D ï쳌© ï쳌° ï쳌µ ï쳌´ ï쳌¡ ï쳌¤ ï쳌¯ ï쳌³ tional interests . Given the tremendous complexity of its ï?? ï?? ï?? ï?? ) . For example , a request has been made to add a new implications , the possibility of attributing or not attributing letter f ) to Article ï?? ï?? that establishes that the following intellectual property rights to biotechnological inventions would also be excluded from patent protection : must comply with such a national policy and not only All or part of living beings as they are found in nature , manifest the interests of some sectors . In its current state , the natural biological processes , the biological material the legislation is unsystematic and vague in many of its found in nature or that which may be isolated , including mandates and concepts . This leaves the door open for a the genome or germplasm of any natural living being . variety of interpretations and applications . This suggestion was proposed with the aim of prevent - With this reality in mind , we will refer briefly to the ing the possibility of patenting any kind of genome ( plants current process of modification of the Chilean intellectual as well ) and not only human genomes . property legislation . It began in ï?? ï?? ï?? ï?? with the presenta - Regarding biotechnology , the relevant suggestions are tion of a Bill by the Executive Power in the National 23 those formulated in relation to the current Article ï?? ï?? of Congress . that seeks to adapt the Chilean legislation to Law No . ï?? ï?? . ï?? ï?? ï?? that states : the international obligations it undertook by subscription to the Marrakech Agreement . ( Indeed , by virtue of the An invention can be patented when it is new , has an inven - ratification of the Marrakech Agreement , Chile acquired tive level , and is susceptible to industrial application . the obligation to adapt its internal legislation in matters of The Bill in process does not incorporate modifications intellectual property . The deadline originally established to this article ; nevertheless , there have been proposals in was ï?? March ï?? ï?? ï?? ï?? . Today , Chile , like many other develop - the parliamentary discussion offering suggestions that ing countries , has not complied with this stipulation ) . would modify it . For example , one proposal would sub - Nevertheless , as we have already mentioned , dur - stitute the following for the text of this article : ing ï?? ï?? ï?? ï?? a Bill introducing modifications to Law No . ï?? ï?? . ï?? ï?? ï?? , Related to the RegulationsApplicable to Industrial Patents can be obtained for all inventions , be they prod - ï?? ï?? ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ ucts or procedures , in all fields of technology , with the As with Article ï?? ï?? , the original bill did not modify this condition that they be new , have an inventive level , and article . However , the Chamber of Deputies formulated the are susceptible to industrial application . Regardless of following paragraph , which aims to replace the text of Article ï?? ï?? of this Law , patents can be obtained and the Article ï?? ï?? with the following : rights of the patents can be used without discrimina - Patents cannot be awarded to inventions whose commer - tory aspects such as the place of invention , the field of cial exploitation needs to be prevented in order to protect technology , or the fact that the products are imported or public order , state security ; ethics and good customs ; produced in the country . the health or life of persons or animals , or to preserve plant material or the environment , whenever such an There has also been a proposal to add a second para - exclusion is not carried out due to the existence of a graph to Article ï?? ï?? , as follows : legal or administrative clause that prohibits or regulates The principle of non - discrimination in technical fields said exploitation . will be recognized by safeguarding and respecting our The Chamber of Deputies â?? Permanent Economic national biological and genetic patrimony , as well as Commission , which is in charge of studying the Bill in the traditional knowledge of indigenous or local com - question , has approved all the above - mentioned para - munities . As a consequence , the concession of patents for graphs . inventions developed on the basis of material obtained We must say , that in Chile , almost all biotechnologi - from that patrimony or knowledge would be subject to cal development is carried out by universities and a few the acquisition of the material in conformance with the government agencies ( mainly ï쳌© ï쳌® ï쳌© ï쳌¡ and ï쳌³ ï쳌¡ ï쳌§ ) , with the relevant international and national Regulations . fundamental aim of preserving resources and developing It is also important to mention the paragraph formu - scientific research . Chile does not have a significant bio - lated by Article ï?? ï?? of Law No . ï?? ï?? . ï?? ï?? ï?? which currently technological industry , nor does it have a particularly de - states that : veloped economic activity in this area . Therefore , most of the pressure for a better adaptation of national intellectual Patents are not awarded to inventions that infringe upon property legislation to the patenting of biotechnological the law ; public order ; state security ; ethics and good developments originates from abroad . To date , this pres - customs ; nor to any inventions presented by whomsoever is not the legitimate owner . sure has not been significant . Bioprospecting Projects in Chile There is currently neither a regulatory framework nor most important have been : the project carried out by the a clear policy regarding this issue . Thus , regarding the International Cooperative Biodiversity Groups ( ICBGs ) , activity of access to genetic resources ( bioprospecting under the guidance of the University of Arizona with the 24 projects ) the approach taken is predominantly contractual collaboration of the Chilean Catholic University ; the pro - and is defined by the particular interests of the contracting gram developed by the British Technology Group and the parties and controlled by the regulations of private law University of Chile , with the participation of the University ( national or international ) . It does not include the concrete of Southampton Agrochemical Unit , the Institute of participation of the countryâ??s environmental authorities . Arable Crops Research , and the Royal Botanical Garden , Practically all cases of bioprospecting have been carried and the program carried out by ï쳌© ï쳌® ï쳌© ï쳌¡ in conjunction with 25 out via Chilean universities and with the supposed aim the Japan International Cooperation Agency ( ï쳌ª ï쳌© ï쳌£ ï쳌¡ ) . To of developing research ( ï쳌¯ ï쳌¤ ï쳌¥ ï쳌° ï쳌¡ ï?? ï?? ï?? ï?? ) . Since Chile does a great degree , these three projects , at the time of their not possess a developed biotechnological industry and no development , motivated the authorities responsible for Chilean stakeholder have shown an interest in developing environmental matters to politically approach the issue the sector , most of the bioprospecting projects have their of genetic resources and their regulation . This led them to origins abroad , be it in the private or public sectors . promote the development of a kind of regulatory instru - Given the fact that no entry control system exists , nor ment and policy to deal with the situations generated by is there an obligation to register , no precise information these types of projects . is available regarding the exact number of bioprospecting As mentioned above , these projects have had a pre - expeditions that have been carried out or are currently dominantly contractual basis , with a minimum or total being carried out in Chile . Nevertheless , these expedi - lack of involvement of the environmental authorities , local tions can be categorized into two clear groups : specific communities , nongovernmental organizations ( ï쳌® ï쳌§ ï쳌¯ s ) , and expeditions , carried out on a small scale and in relation indigenous groups . The majority of these projects have to certain very special species ( these probably constitute adopted the ï쳌£ ï쳌¢ ï쳌¤ â?? s general principles and rules in order to the majority but are less often registered ) , and large scale define their frameworks . Nevertheless , in practice , their bioprospecting programs , which consist of the systematic development has generated a great deal of distrust , while analysis of samples in considerably large terrains carried the willingness of the parties involved to comply with out over significant periods of time . Among the latter the these principles and rules has been questioned by various ï?? ï?? ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? ï?? : C ï쳌¨ ï쳌© ï쳌¬ ï쳌¥ sectors . The main criticism , apart from the lack of real par - lected material to the Royal Botanical Garden , Kew ticipation , is related to the absence of clarity and certainty ( Transfer Notification in Appendix ï?? of the con - regarding the benefits owed to Chile or to its citizens in tract ) ; a pledge of noncommercialization of trans - exchange for access to genetic resources . ferred genetic resources , unless expressly agreed This lack of participation and transparency is not upon by the involved parties ; a just and equitable necessarily nor exclusively due to the unwillingness of distribution of the benefits ; regulation of transfer those involved in the projects . Rather , it is due to the fact of collected material to third parties ( stipulated in that the Chilean authorities responsible for environmental an Appendix ï?? ) ; a pledge to treat confidential in - matters have been incapable of offering clear guidelines formation in a confidential manner ; and duration regarding the procedures to follow , the organizations to of the contract and conflict resolution . be consulted , the principles and rules to be respected , etc . â?¢ Contract of Access to germplasm , signed by ï쳌© ï쳌® ï쳌© ï쳌¡ This is mainly due to the absence of a framework that regu - and the C.M . Rick Tomato Genetics Resource lates genetic resources in Chile . Because of the absence Center ( ï쳌´ ï쳌§ ï쳌² ï쳌£ ) , of the University of California , of public sector regulations , private law has been applied , Davis ( ï?? October ï?? ï?? ï?? ï?? ) . Via this contract , ï쳌© ï쳌® ï쳌© ï쳌¡ in all legitimacy , and the private interests of contracting expressly grants its previously informed consent parties have prevailed . to the ï쳌´ ï쳌§ ï쳌² ï쳌£ to collect germplasm ( seeds ) samples Regarding organizations linked to the public sector , it is from species and from places expressly indicated important to highlight the work of ï쳌© ï쳌® ï쳌© ï쳌¡ in the contracting in the contract . The fundamental contents of the and development of bioprospecting projects . In compliance contract are as follows : the restriction of collection with its programs , ï쳌© ï쳌® ï쳌© ï쳌¡ has subscribed to various contracts of material so as not to put the respective population of access to genetic resources in Chile . Below we describe in danger of extinction ; ï쳌´ ï쳌§ ï쳌² ï쳌£ pledge not to claim the fundamental aspects of two such contracts . It is impor - property rights over the germplasm collected ; equi - tant to emphasize that in both cases the parties recognize table distribution of collected material between the the sovereign rights of states over their own biological involved parties ; regulation of transfer of collected resources while making a commitment to comply with the material to third parties ; pledge to share information contents and the spirit of ï쳌£ ï쳌© ï쳌´ ï쳌¥ ï쳌³ , ï쳌£ ï쳌¢ ï쳌¤ , and the national laws generated among parties involved ; ï쳌´ ï쳌§ ï쳌² ï쳌£ pledges to and regulations related to biodiversity , including access to assist ï쳌© ï쳌® ï쳌© ï쳌¡ in increasing its technical capacities and plant genetic resources and their transfer . genetic resource research ; and conflict resolution . â?¢ Contract of Access to and Participation in the The differences between these contracts lie in the Benefits , signed by ï쳌© ï쳌® ï쳌© ï쳌¡ and the Trustee of the clauses that do not refer to the essence of the agreement Royal Botanical Garden , Kew , United Kingdom ( for example , duration of the contract , conflict resolution ( ï?? July ï?? ï?? ï?? ï?? ) . Via this contract , ï쳌© ï쳌® ï쳌© ï쳌¡ expressly mechanisms , and future technical cooperation pledge ) . The awards its previously informed consent to the essential elements are practically the same , consisting of : â?? Ex Situ Conservation of Endemic , Vulnerable , previously informed consent , declaration of equitable and Endangered Species from the Desert and distribution of benefits , and regulation of the transfer of Mediterranean Zones in Chile â?쳌 project which is material collected to third parties . As these contracts are to be carried out by both institutions , according to the project summary attached in Appendix ï?? of just starting to be implemented there is yet no information this contract . The main clauses of the contract refer about their results . to the following aspects : terms of transfer of col - Conclusions As has been explained throughout this paper , to date policies to the government and as a national focal point Chile has not yet developed a structural framework for for the ï쳌£ ï쳌¢ ï쳌¤ . Regarding a strategy for the formulation of the general implementation of the ï쳌£ ï쳌¢ ï쳌¤ , which would be a the access and benefit - sharing regime , ï쳌£ ï쳌¯ ï쳌® ï쳌¡ ï쳌­ ï쳌¡ and the necessary base for specific formulation of an access and other institutions with some competence on the subject benefit distribution regime on the basis of objectives , goals , will have to consider the different formal systems by which and priorities previously determined . However , the cur - the matter can be treated through a legal , contractual or rent National Biodiversity Strategy and the future National voluntary approach . In addition , it will be necessary to Biodiversity Action Plan are steps in the right direction . decide whether to structure regulation through an integral We have yet to see the results of the process leading to formula ( framework ) or a flexible one ( amendments to the a National Biodiversity Action Plan , but it is certainly existing legislation ) , of immediate or gradual development . an approach that considers the integral and systematic The characteristics and the effectiveness of the legislative implementaion of the ï쳌£ ï쳌¢ ï쳌¤ . and institutional framework that regulates access to the This process is being coordinated by ï쳌£ ï쳌¯ ï쳌® ï쳌¡ ï쳌­ ï쳌¡ in its genetic resources of each country will have a close relation role as the authority in charge of proposing environmental to the process through which this framework is developed ï?? ï?? ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ and implemented . resources and , in addition , to establish if the resources at Once established , in order to operate efficiently the issue are shared with other countries . Such a process also legislative framework must , at least , fit within the national allows the establishment of wider objectives and national strategy for the conservation and the sustainable use of policies , while facilitating the evaluation of the existing biological diversity and be endorsed by institutional pro - institutions , laws , and policies . Since the regulation of ac - cedures with sufficient capacities for implementation . cess to the genetic resources is a new area of legislation , The effective formulation of a legal regime of access to few countries have the necessary institutions and resources genetic resources requires the participation of a high num - for its implementation . To develop this capacity requires a ber of interest groups and experts . Governmental entities long - term process and , for that reason , it is vital to begin of different sectors must participate in the process as well it as soon as possible . However , considering the elements as representatives of the scientific community and the pri - mentioned before , it is clear that there are tensions between vate sector ( for example , pharmaceutical and agricultural the urgent need to take measures and the complexity of the companies ) , local and indigenous groups , and ï쳌® ï쳌§ ï쳌¯ s . The process . Evidently the ï쳌£ ï쳌¢ ï쳌¤ is a superstructure difficult to collective experience and the technical knowledge of all implement for developing countries , and Chile is a clear the sectors will not only benefit the legislative process , but example of this difficulty . Throughout recent years there also will help to identify any type of potential opposition has been only erratic consideration of the subject , and it to the legislation . has never been considered a question of importance for the When formulating the regulatory framework it is also national interests , which is demonstrated by a clear lack of important to have an integrated approach , so that the sub - serious actions on the part of the political authorities . ject is not treated in an isolated manner . The regulatory The subject is so difficult and complex that it is neces - framework at issue would have to be integrated within a sary to surpass the way in which these subjects are tra - broader set of policies and governmental activities . The ditionally approached . The issue can be seen and treated discussion on how to regulate genetic resources would from an ideal perspective or a practical perspective . The have to be carried out through a process of national plan - latter is able to diagnose and to recognize all the present ning , as required by Article ï?? of the ï쳌£ ï쳌¢ ï쳌¤ . A similar process difficulties and obstacles at stake to obtain the desired offers the opportunity to gain important knowledge on objectives and goals . We consider it advisable to follow a the state and distribution of the biological diversity of pragmatic approach to the subject in Chile , and to develop the country , which is important to determine the more a process in a reasonable time frame with predetermined attractive geographic zones for the exploration of genetic objectives , priorities , and goals . References A ï쳌§ ï?¼ ï쳌¥ ï쳌² ï쳌¯ T . ï?? ï?? ï?? ï?? . Recursos genéticos terrestres nativos de G ï쳌© ï쳌¬ . L . and C . I ï쳌² ï쳌¡ ï쳌² ï쳌² ï?¡ ï쳌º ï쳌¡ ï쳌¢ ï쳌¡ ï쳌¬ . ï?? ï?? ï?? ï?? . Estado actual de la bio - tecnología en Chile . p . ï?? â?? ï?? in Proceedings of workshop Chile : Una propuesta para su conservación y uso sustent - Biotecnología en Chile : Oportunidades de Innovación able . Temporada Agrícola ï?? ï?? : ï?? ï?? ï?? â?? ï?? ï?? ï?? . Tecnológica . î?? î?? î?? î?? î?? î?¡ î?® î?? î?? - Chile . C ï쳌¡ ï쳌­ ï쳌¡ ï쳌² ï쳌¡ ï쳌¤ ï쳌¥ D ï쳌© ï쳌° ï쳌µ ï쳌´ ï쳌¡ ï쳌¤ ï쳌¯ ï쳌³ . ï?? ï?? ï?? ï?? . Informe de la Comisión I ï쳌² ï쳌© ï쳌¡ ï쳌² ï쳌´ ï쳌¥ A . ï?? ï?? ï?? ï?? . Regulaciones al acceso a los recursos Permanente de Economía de la Cámara de Diputados , biológicos en Chile : Un desequilibrio entre flora y sobre el Proyecto de Ley de Propiedad Intelectual . Chile . fauna silvestre . p . ï?? ï?? â?? ï?? ï?? in B . T ï쳌© ï쳌­ ï쳌­ ï쳌¥ ï쳌² ï쳌­ ï쳌¡ ï쳌® and G . ï쳌£ ï쳌¯ ï쳌® ï쳌¡ ï쳌­ ï쳌¡ ï?? ï?? ï?? ï?? . Estudio de diagnóstico sobre la propiedad y el M ï쳌¯ ï쳌® ï쳌´ ï쳌¥ ï쳌® ï쳌¥ ï쳌§ ï쳌² ï쳌¯ ( eds . ) Noticiero de Biología . Organo acceso a los recursos genéticos . Comisión Nacional del Oficial de la Sociedad de Biología de Chile . Taller Medio Ambiente ( î?? î?¡ î?? î?? î?? î?? ) , Chile , unpublished manu - Internacional : Aspectos ambientales , eticos , ideológicos script . y políticos en el debate sobre bioprospección y uso de ï쳌£ ï쳌¯ ï쳌® ï쳌¡ ï쳌­ ï쳌¡ ï?? ï?? ï?? ï?? . Informe sobre recursos genéticos y el orde - recursos genéticos en Chile . namiento constitucional Chileno . Comisión Nacional del ï쳌¯ ï쳌¤ ï쳌¥ ï쳌° ï쳌¡ . ï?? ï?? ï?? ï?? . Investigación , uso y protección de los recur - Medio Ambiente ( î?? î?¡ î?? î?? î?? î?? ) , Chile . sos genéticos endémicos y nativos de Chile . Oficina de ï쳌£ ï쳌¯ ï쳌® ï쳌¡ ï쳌­ ï쳌¡ ï?? ï?? ï?? ï?? . Propuesta de registro nacional de contratos de Estudios y Políticas Agrarias ( ï쳌¯ ï쳌¤ ï쳌¥ ï쳌° ï쳌¡ ) , Ministerio de acceso a los recursos genéticos . Comisión Nacional del Agricultura , Chile . Medio Ambiente ( î?? î?¡ î?? î?? î?? î?? ) , Chile . U ï쳌® ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌¤ ï쳌¡ ï쳌¤ ï쳌¤ ï쳌¥ C ï쳌¨ ï쳌© ï쳌¬ ï쳌¥ . ï?? ï?? ï?? ï?? . Informe país : Estado del medio C ï쳌µ ï쳌¢ ï쳌© ï쳌¬ ï쳌¬ ï쳌¯ ï쳌³ A . and P . L ï쳌¥ ï?³ ï쳌® . ï?? ï?? ï?? ï?? . Informe de la República de ambiente en Chile â?? ï?? ï?? ï?? ï?? . Centro de Análisis de Políticas Chile para la ï쳌¦ ï쳌¡ ï쳌¯ . Chile . Públicas . Chile . ï?? ï?? ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? ï?? : C ï쳌¨ ï쳌© ï쳌¬ ï쳌¥ Endnotes 1 13 In the case of the private sector there is no important development Generally speaking , in compliance with its internal law , this Service must safeguard the conservation of agricultural flora . This in this field . means that it is not accountable for forest resources ( under ï쳌£ ï쳌¯ ï쳌® ï쳌¡ ï쳌¦ ) 2 After the publication of Supreme Decree No . ï?? ï?? ï?? ï?? , ï?? ï?? ï?? ï?? , from the and wild flora ( which is not currently under the express charge Ministry of Foreign Affairs , in the Official Journal , ï?? May ï?? ï?? ï?? ï?? . of any institution , apart from the regulations that correspond to 3 When set into practice , this national plan should be a significant protected wild areas ) . element of the environmental policy of the country . 14 This law is not yet in force since it is subordinate to the constitu - 4 Consultants were hired to make a comparative study of national tion of ï쳌£ ï쳌¯ ï쳌® ï쳌¡ ï쳌¦ as a public institution , according to Law No . ï?? ï?? . ï?? ï?? ï?? . access legislation . This study was merely for updating the infor - 15 Third clause of the agreement . mation available in ï쳌£ ï쳌¯ ï쳌® ï쳌¡ ï쳌­ ï쳌¡ and was finished in March ï?? ï?? ï?? ï?? . It 16 Fourth Clause of the Agreement . formulated some ideas for starting a new regulatory process in 17 Chile , but its consequences and possible continuation are uncertain Fifth Clause of the Agreement . ( ï쳌£ ï쳌¯ ï쳌® ï쳌¡ ï쳌­ ï쳌¡ ï?? ï?? ï?? ï?? ) . 18 Sixth Clause of the Agreement . 5 This statement is given on the basis of a legal rule established by 19 Seventh Clause of the Agreement . the Chilean Civil Code : â?? the accessory follows the principal or 20 In compliance with ï쳌© ï쳌® ï쳌© ï쳌¡ Resolution Nº ï?? ï?? ï?? , ï?? August ï?? ï?? ï?? ï?? , the main thing â?쳌 . This rule states that the owner of a good is entitled to following functions are granted to the General Guardian of Plant ownership of any of its products or other things which constitute Genetic Resources : the authority to plan , organize , co - ordinate , a unity with the original or main good ( articles ï?? ï?? ï?? to ï?? ï?? ï?? , Civil conduct studies of removal , collect plant genetic diversity , inter - Code ) . change germplasm , and assign a single serial and sequence number 6 Those things that , being susceptible of appropriation , do not belong for each access agreement that enters the system ; to participate in to anybody and which , therefore , any person can acquire the decision making related to quarantine , evaluation , characterization , ownership of . Indeed , according to Chileâ??s Civil Code , the owner - classification , documentation , information diffusion activities , and ship of things that do not belong to anybody is acquired via use . adoption of the appropriate measures for conservation and sustain - Hunting and fishing are a type of use through which ownership of able use of plant genetic resources ; and to act as consultant and wild animals is acquired ( Articles ï?? ï?? ï?? and ï?? ï?? ï?? ) . member of the National Commission of Plant Genetic Resources . 7 For example , Law No . ï?? ï?? . ï?? ï?? ï?? on General Bases of Environment ; 21 Eighth clause of the agreement . Law No . ï?? ï?? . ï?? ï?? ï?? that creates the National System of Protected Wild 22 Article ï?? ï?? , Law No . ï?? ï?? . ï?? ï?? ï?? : The following are not considered Areas of the State ; Law No . ï?? ï?? . ï?? ï?? ï?? for hunting ; Law No . ï?? ï?? . ï?? ï?? ï?? , inventions and are excluded from this lawâ??s patent protection : . . . b ) the General Law of Fishing and Aquaculture ; Law No . ï?? ï?? . ï?? ï?? ï?? on plant material varieties and animal species . National Monuments ; Decree No . ï?? . ï?? ï?? ï?? on Agricultural Protection ; 23 Bill currently in process ( Bulletin No . ï?? ï?? ï?? ï?? - ï?? ï?? Chamber of and the Decree No . ï?? . ï?? ï?? ï?? on Acquisition , Administration and Deputies ) . Disposition of Government properties . All these regulations will be 24 mentioned in the following part of this paper . This project lasting five years , started in ï?? ï?? ï?? ï?? , under an agreement 8 between the University of Arizona ( î?° î?? ) and the Catholic University Alongside this permission , access will depend on the express ( î?° î?? ) with the purpose of preparing and supplying samples of authorization of the landowner . biological material by the î?° î?? to î?° î?? . Regarding benefit - sharing 9 This Service is in charge of wild fauna , according to its organic law . the agreement establishes that any royalties on the sale of com - 10 The following are protected areas and other special zones : virgin pounds isolated from extracts of plants collected in Chile will be area reserves , national parks , national reserves , natural monuments , distributed in the following way : ï?? ï?? % of all royalties to a fund for nature sanctuaries , areas where hunting is prohibited , urban zones , conservation and for the benefit of local people in the country of railway tracks , airports , ( in and from ) public roads , places of scien - collection ; ï?? % of all royalties to the collector of the plant that is the tific interest , and settlements of fertilizing wildfowl ( Article ï?? first source of the commercialized compound ; and ï?? ï?? % of all royalties paragraph of the Hunting Law ) . to the institutions employing those named as inventors on patents 11 Article ï?? ï?? ï?? of the Civil Code : â?? Plants are property if they adhere to covering the commercialized compound . This project was renewed the ground by their roots , unless they are in pots or boxes that can in ï?? ï?? ï?? ï?? for another five years , and , according to the little informa - be moved from one place to another . â?쳌 tion we were able to obtain , the main objective of this second phase was conservation rather than bioprospecting . The project ended in 12 ï쳌£ ï쳌¯ ï쳌® ï쳌¡ ï쳌¦ is a private legal entity regulated by its own statutes , which ï?? ï?? ï?? ï?? . must , among other functions , participate in the state management 25 and development of forests made up of National Parks , Forest The Governments of Japan and Chile signed an agreement in ï?? ï?? ï?? ï?? Reserves , and State Woods . That is , ï쳌£ ï쳌¯ ï쳌® ï쳌¡ ï쳌¦ must safeguard the to develop , during the following five years , a program for the natural patrimony in situ , within the protected wild areas and all â?? Conservation of Genetic Resources â?쳌 that would be implemented forests . by ï쳌ª ï쳌© ï쳌£ ï쳌¡ and ï쳌© ï쳌® ï쳌© ï쳌¡ . ï?? ï?? ï?? ï?? ï?? ï?? 11 Malaysia : Recent Initiatives to Develop Access and Benefit - Sharing Regulations Mohamad Osman Malaysia consists of two large landmasses over ï?? ï?? ï?? mately ï?? , ï?? ï?? ï?? mm , with most precipitation occurring during km apart separated by the South China Sea . Peninsular the southwest monsoon ( September to December ) . East Malaysia is a continuum of the Asian continent , a nar - Malaysia receives most of its rainfall during the northeast row landmass sandwiched by Thailand in the north and monsoon ( October to February ) . Sabahâ??s average annual Singapore in the south , comprising eleven states , namely , rainfall is ï?? , ï?? ï?? ï?? mm , while Sarawakâ??s average is approxi - Perlis , Kedah , Pulau Pinang , Perak , Kelantan , Terengganu , mately ï?? , ï?? ï?? ï?? mm . There is , however , great variation in Pahang , Selangor , Negeri Sembilan , Melaka , and Johor , rainfall between locations . For example , northern Perlis on and two Federal Territories , namely , Kuala Lumpur and the average receives only half of Terengganuâ??s annual rain - newly established Putrajaya . East Malaysia , comprising fall , whereas parts of eastern Sarawak receive more than the states of Sabah , Sarawak , and the Federal Territory ï?? , ï?? ï?? ï?? mm of annual rainfall . Average annual temperature of Labuan , is situated on the island of Borneo and is is ï?? ï?? ° C with a diurnal range of ï?? ° C . Relative humidity is bordered by Brunei and Kalimantan , Indonesia ( Figure high ( ï?? ï?? to ï?? ï?? % ) , especially in the coastal areas . ï?? ) . The country occupies about ï?? ï?? ï?? , ï?? ï?? ï?? km ² of land area , Almost one - half of the total surface area of the Peninsula of which ï?? ï?? % is the Peninsula and ï?? ï?? % East Malaysia . is granite of the Triassic Age . The central core is domi - Malaysiaâ??s population was ï?? ï?? . ï?? million in ï?? ï?? ï?? ï?? ( date of nated by a series of parallel mountain ranges , which run the last Malaysian census ) . About ï?? ï?? % of the total popula - northwest to southeast along the length of the Peninsula . tion resides in Peninsular Malaysia , ï?? . ï?? % in Sabah , and Sabah is crisscrossed by a series of mountain ranges with ï?? . ï?? % in Sarawak . the Crocker Range dominating its topography . Sarawakâ??s Malaysiaâ??s territorial waters cover an area of ï?? ï?? ï?? , ï?? ï?? ï?? topography shows a flat coastal plain followed by a narrow km ² . Its maritime area borders Indonesia , Singapore , belt of many hills with a sharp rise of mountainous mass Thailand , Brunei , and the Philippines . The principal extending the full length of the state . Malaysia receives water bodies are the Straits of Malacca and the South approximately ï?? ï?? ï?? billion m ³ of rainfall annually , of which China Sea . The Straits of Malacca , one of the worldâ??s ï?? ï?? % appears as surface run - off and ï?? . ï?? % recharges the busiest shipping passages , is a narrow sea - lane between groundwater aquifers . Of this total , ï?? ï?? ï?? billion m ³ return Peninsular Malaysia , the Indonesian island of Sumatra , and to the atmosphere by evaporation and transpiration , leav - Singapore . The South China Sea is significant because of ing an estimated ï?? ï?? ï?? billion m ³ as theoretically available its continental shelf which is extremely rich in nutrients water resources . Only approximately ï?? ï?? % of the water and able to support a remarkable diversity of species . resources are found in the Peninsula . Malaysia has a hot and humid tropical climate marked Of a total of ï?? ï?? . ï?? million ha of land , ï?? . ï?? ï?? million , ï?? . ï?? ï?? by seasonal variations in rainfall . Generally , the climate is million , and ï?? . ï?? ï?? million ha are estimated to be suitable for influenced by the northeast and southwest monsoons . The agriculture in Peninsular Malaysia , Sabah , and Sarawak , annual average rainfall in Peninsular Malaysia is approxi - respectively . The sector is dominated by plantation crops , ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ Figure ï?? . Map of Malaysia of which rubber and oil palm occupied ï?? ï?? . ï?? % and ï?? ï?? . ï?? % potential . Forests constitute the bulk of nonagricultural respectively of the total land area in ï?? ï?? ï?? ï?? , followed by land in Sabah with ï?? ï?? . ï?? % or ï?? . ï?? million ha in ï?? ï?? ï?? ï?? , out cocoa . Of the food crops , rice is the most important , fol - of which ï?? . ï?? ï?? million ha were still undisturbed . This con - lowed fruits and vegetables . Almost all the forests cleared sists mainly of mangroves and swamps , lowland and hill for agricultural development were lowland forests with dipterocarp , and montane forests . Deforestation of over their large reservoir of genetic diversity of fauna and flora , ï?? ï?? % of the stateâ??s undisturbed lowland and highland dip - because their high soil productivity was deemed ideal for terocarp forests during the last two decades has resulted agricultural production . in an overwhelming gross domestic product growth by the Sarawak agricultural land use constitutes almost a third forestry sector in Sabah . Because of their differing histo - of the total land area . The major user of agricultural land in ries , geographic locations and physical features , Peninsular Sarawak is shifting cultivation , or slash and burn farming , Malaysia and East Malaysia are significantly different in that accounted for ï?? ï?? . ï?? % of the total land area in ï?? ï?? ï?? ï?? . their biological holdings . Both areas are inhabited by many Shifting cultivation is the traditional way of life for the endemic species , while even shared species have distinct ethnic and native peoples . It is estimated that ï?? % of virgin genetic differences . forests are cleared annually for shifting cultivation . By Malaysia is identified as one of the worldâ??s twelve contrast in Sabah , agricultural land use comprises only a megadiversity countries with extremely rich biological small percentage of total land area ( ï?? . ï?? % in ï?? ï?? ï?? ï?? ) . In ï?? ï?? ï?? ï?? , resources . Tropical forests , the most biologically diverse oil palm was the major land user at ï?? . ï?? % of total land area ecosystems on earth , cover much of the country . There are and cocoa was the second major crop with ï?? . ï?? % of the land over ï?? ï?? , ï?? ï?? ï?? known species of flowering plants , ï?? ï?? ï?? species area . Forest lands constituted approximately ï?? , ï?? ï?? ï?? , ï?? ï?? ï?? ha of mammals , over ï?? ï?? ï?? , ï?? ï?? ï?? species of invertebrates , over ( or ï?? ï?? % of Peninsular Malaysiaâ??s total land area ) in ï?? ï?? ï?? ï?? , ï?? , ï?? ï?? ï?? species of butterflies and ï?? ï?? , ï?? ï?? ï?? species of moth , and of which ï?? , ï?? ï?? ï?? , ï?? ï?? ï?? ha is designated as Permanent Forest over ï?? , ï?? ï?? ï?? species of marine fishes in Malaysiaâ??s varied Estates ( ï쳌° ï쳌¦ ï쳌¥ s ) . The demand for land use , however , has ecosystems , and the list goes on . led to the delisting of ï?? ï?? ï?? , ï?? ï?? ï?? ha of ï쳌° ï쳌¦ ï쳌¥ s in Peninsular Therefore , Malaysia offers many opportunities to Malaysia and ï?? ï?? ï?? , ï?? ï?? ï?? ha in East Malaysia from ï?? ï?? ï?? ï?? to bioprospectors , and policy - makers have been working ï?? ï?? ï?? ï?? , largely for agricultural use . to develop regulations that promote and facilitate bio - As of ï?? ï?? ï?? ï?? , Sarawak was still largely covered by forests prospecting in the country . This chapter analyses current ( over ï?? ï?? % of the total land area was under ï쳌° ï쳌¦ ï쳌¥ s and other and future laws and policies that regulate access to these forests ) . ï쳌° ï쳌¦ ï쳌¥ s also include areas that have been developed genetic resources , the process that is leading to the devel - for the production of forest products and logged - over opment of these laws , and bioprospecting initiatives that areas replanted with forest species that have good timber have been implemented in Malaysia . ï?? ï?? ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? ï?? : M ï쳌¡ ï쳌¬ ï쳌¡ ï쳌¹ ï쳌³ ï쳌© ï쳌³ ï쳌¡ Ownership of Genetic Resources and ythe Federal - State Jurisdictional Dichotom In Malaysia , the Constitution allocates to the thirteen states sovereignty over such resources brings up several issues ownership of land and any minerals on or within it . More in need of resolution ( O ï쳌¨ ï?? ï?? ï?? ï?? ) . The question of rights complex is the situation regarding inhabitants of the land . to access within the country presents a Federal - State ju - For example , Sabah and Sarawak have a different consti - risdictional dichotomy . tutional status vis - à - vis the Federal Government . Prior to joining the Federation , they signed a ï?? ï?? - point agreement The Federal - State Jurisdictional with the Federation of Malaysia that guaranteed them spe - Dichotomy cial rights . Sabah and Sarawak are excluded from national In Malaysia , the Federal - State jurisdictional dichotomy plans for land use , local government , and development.As 1 means that the jurisdiction over land and natural re - a result , the indigenous or local communities in Sabah sources lies with the State governments and not the have been accorded certain special legal rights over land . Federal Government . While it is the Federal Government In a way , we can think of such lands as lands that have that possesses the authority to enter into international been alienated to the indigenous communities . Legally , the agreements , such as the Convention on Biological indigenous communities do not â?? own â?쳌 the minerals found Diversity ( ï쳌£ ï쳌¢ ï쳌¤ ) , under the Ninth Schedule of the Federal in that land even though they are accorded certain special Constitution , State governments govern land and natural rights over the land . However , biological / genetic resources resources . This division of responsibilities causes difficul - are not explicitly addressed in the law . It is , therefore , still ties in implementing national policies and international uncertain whether the indigenous communities fully hold commitments . The management of the environment and the â?? proprietary rights â?쳌 or â?? access â?쳌 to biological / genetic biological diversity in Malaysia is the joint responsibil - resources . ity of Federal , State , and local governments . The Federal Sabahâ??s land law , enacted under the Land Ordinance Constitution divides legislative power between the Federal ï?? ï?? ï?? ï?? , permits native customary rights over certain lands and State Governments into three lists : Federal , State , and to indigenous peoples . The Sabah Land Law recognizes Concurrent lists . Neither the environment nor biological special classes of land rights , namely , native title to land diversity appears in the three constitutional lists as a mat - and native reserves , which are applicable only to the native ter for legislation , but are instead defined in their related peoples . The situation is different in Peninsular Malaysia , subjects under all three lists . where the indigenous communities are not accorded cus - The Federal Government has jurisdiction over com - tomary rights over land , even though the land may have merce , trade , and industry , and is responsible for envi - been occupied and cultivated by them for long periods ronmental protection and pollution prevention . The State of time . In Peninsular Malaysia , indigenous communities Governments have control over land , water , agriculture , occupy lands that have been reserved or designated for forestry , and local governments , and thus retain jurisdic - them by the States . As in Sabah and Sarawak , it is still tion to protect , manage , and utilize natural resources . At uncertain whether the native people fully hold the pro - the same time , both Federal and State Governments may prietary rights or access to biological / genetic resources exercise concurrent jurisdiction over issues such as the found on their lands . protection of wildlife and national parks , land rehabilita - It is also uncertain whether private landholders own tion , fishing and fisheries , and agriculture . The distinct the biological / genetic resources found on their land . This division of Constitutional responsibility to the Federal and question remains open , but on the premise that private State Governments respectively has far - reaching implica - properties are considered as alienated lands , the relevant tions for the management and use of natural resources State may no longer hold the proprietary rights or access to and biological diversity , and undermines all efforts for a biological / genetic resources found on such lands . However , comprehensive and effective management of the environ - it is clearly stated in law that the State holds the proprietary ment . rights or access to minerals found on lands . An example of the dilemma this situation presents is The constitutional situation in Malaysia prevents the in the management of Marine Parks . Legislative control legal implementation of a general and all - encompassing over land and forests and the sea up to a limit of three law governing all types of genetic resources and ben - km offshore is with the State governments . The Federal efits . Indeed , it would be very difficult for a nationally government has jurisdiction over the sea from three km to administered policy or law to cover all of Malaysiaâ??s the Exclusive Economic Zone limits , ï?? ï?? ï?? nautical miles biodiversity . The Federal Government does not have the offshore . It also has control over the fisheries and estuarine legal competency to do so . However , the Constitution does resources in Peninsular Malaysia , but shares concurrent allow the Federal Government to take a coordinating role . responsibilities for the resources in Sabah and Sarawak . For example , a federal law that ensures access to genetic While the State Governments have jurisdiction over the resources is consistent on a nationwide basis . However , within the national boundaries , the concept of national land - based resources of islands , the Federal Government ï?? ï?? ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ has jurisdiction over the marine resources of Marine Parks . Sarawak . The Federal Government has weaker jurisdiction This often results in the use of island resources that are in over the East Malaysian states relative to the Peninsular conflict with the objectives of marine park management Malaysian States . The States , Sabah and Sarawak in systems . A conflict of interests between the Federal and particular , will therefore have to develop clearly defined State governments can be detrimental to efforts to protect mechanisms at the state level and more refined Federal - and conserve marine biological diversity . State coordination for effective implementation of inter - The implementation of an international convention that national commitments . requires the management of a resource under state jurisdic - Another related issue is the right of indigenous and tion must be endorsed by the relevant State government.An local communities to control access to biological diversity example is the allocation of the ï?? ï?? , ï?? ï?? ï?? ha Tasek Bera site and to receive benefits generated therefrom . This question in the State of Pahang for designation as a site under the relates to the rights of indigenous and local communities Ramsar Convention . The area continues to remain under to control access to their land and to the resources on those Pahang State jurisdiction ; however , it may be delisted as lands.Again , in terms of the Federal - State dichotomy with a Ramsar site if the State so wishes . It should be noted regard to special biodiversity rights , the implementation of that the situation may be even more complex in Sabah and any changes in the policy will present problems . Implementation of the CBD in Malaysia Malaysia was one among the first countries to sign the unknown and yet to be discovered and studied since tropi - final text of the ï쳌£ ï쳌¢ ï쳌¤ at the Earth Summit in June ï?? ï?? ï?? ï?? , cal forests cover much of the country . and it ratified the treaty on ï?? ï?? June ï?? ï?? ï?? ï?? . Having ratified The national policy outlines the objectives and provides the ï쳌£ ï쳌¢ ï쳌¤ , Malaysia has incorporated it into its national the direction for the nation to implement strategies and ac - policies and is planning more commitments under the tion plans to conserve Malaysiaâ??s biological diversity and treaty ( Table ï?? ) . At the national level , Malaysiaâ??s efforts to ensure that its components are utilized in a sustainable to implement the ï쳌£ ï쳌¢ ï쳌¤ are led by the Ministry of Science , manner for the continued progress and socio - economic Technology , and the Environment ( ï쳌­ ï쳌¯ ï쳌³ ï쳌´ ï쳌¥ ) . To coordi - development of the country . Among the objectives are nate these efforts , a National Committee on Biological to optimize economic benefits from sustainable utiliza - Diversity ( ï쳌® ï쳌£ ï쳌¢ ï쳌¤ ) was established under ï쳌­ ï쳌¯ ï쳌³ ï쳌´ ï쳌¥ and chaired tion of the components of biological diversity , to ensure by the Secretary - General of ï쳌­ ï쳌¯ ï쳌³ ï쳌´ ï쳌¥ . Established under this long - term food security for the nation , to maintain and National Committee is the National Technical Committee improve environmental stability for proper function - on Biological Diversity and its three task forces working on ing of ecological systems , to ensure preservation of the specific issues : the country study on biological diversity , unique biological heritage of the nation for the benefit the national policy on biological diversity , and access to ge - of present and future generations , to enhance scientific netic resources.A national Genetic ModificationAdvisory and technological knowledge and the educational , social , Committee ( ï쳌§ ï쳌­ ï쳌¡ ï쳌£ ) was also established . cultural and aesthetic values of biological diversity , and As a party to the ï쳌£ ï쳌¢ ï쳌¤ , Malaysia has the responsibility to to emphasize biosafety considerations in the development conserve and utilize its biological diversity resources in a and application of biotechnology . It is the hope and the sustainable way . Based on a country study on biological di - aspiration of the Government to transform Malaysia into versity that resulted in the document entitled â?? Assessment a world center of excellence in conservation , research , of Biological Diversity in Malaysia â?쳌 ( ï쳌­ ï쳌¯ ï쳌³ ï쳌´ ï쳌¥ ï?? ï?? ï?? ï?? ) , the first and sustainable utilization of tropical biological diversity step taken by the country was to develop a national strategy by the year ï?? ï?? ï?? ï?? . 2 on biological diversity that would integrate conservation Both to safeguard and manage these rich biological and sustainable use of biological resources into plans , pro - resources in a sustainable manner as well as to support grams , and policies for sectors such as agriculture , fisher - the National Policy on Biological Diversity and the ï쳌£ ï쳌¢ ï쳌¤ , ies , and forestry , and for cross - sectoral matters such as Sarawak passed a State law in ï?? ï?? ï?? ï?? to establish the Sarawak land - use planning and decision making . This Assessment Biodiversity Council and the Sarawak Biodiversity Center was commissioned as part of Malaysiaâ??s international to manage the Stateâ??s rich biodiversity in a prudent man - commitment.As a consequence , the Government launched ner . Similar steps were taken by the State of Sabah which the National Policy on Biological Diversity on ï?? ï?? April enacted the Sabah Biodiversity Ordinance in ï?? ï?? ï?? ï?? and ï?? ï?? ï?? ï?? . This national policy provides important guidelines subsequently established the Sabah Biodiversity Center . to States and institutions in Malaysia to take affirmative To strengthen further the governance of biological diversity actions to safeguard the countryâ??s biodiversity heritage . in this country , the Government is now in the process of These guidelines are important to Malaysia , in particular to finalizing a number of major commitments , namely , the states like Sarawak and Sabah , because it contains within Access to Genetic Resources Bill , the Biosafety Bill , and its boundary immense biodiversity , much of which is still the Plant Variety Protection Bill . ï?? ï?? ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? ï?? : M ï쳌¡ ï쳌¬ ï쳌¡ ï쳌¹ ï쳌³ ï쳌© ï쳌³ ï쳌¡ Current Measures that Regulate Access Currently , there is no access regime in place at the national sures predate the ï쳌£ ï쳌¢ ï쳌¤ . For example , at the national level , level with regard to access control and benefit sharing . Few a minimum procedure has already been put in place to specific measures currently exist in Malaysia to regulate control access to genetic resources by foreign nationals . access to biological resources , with the exceptions of the The Economic Planning Unit ( ï쳌¥ ï쳌° ï쳌µ ) , located within the states of Sarawak and Sabah . Prime Ministerâ??s Department , administers the scheme . Some national - and state - level access controls are Foreign researchers intending to conduct research in the already in place for foreign researchers , but such mea - country need to obtain permission from the Government of Malaysia to do so . The permission granted by ï쳌¥ ï쳌° ï쳌µ is really not a permit , so a foreign researcher has to further Table ï?? . The ï쳌£ ï쳌¢ ï쳌¤ and Malaysiaâ??s actions and commit - obtain the relevant license / permit from Sabah or Sarawak . ments , in chronological order The permission is required even in areas where the fed - ï?? ï?? ï?? ï?? Malaysia signed the ï쳌£ ï쳌¢ ï쳌¤ during the Earth Summit in eral government has no jurisdiction ( i.e . , the States ) . ï쳌¥ ï쳌° ï쳌µ Rio on ï?? ï?? June . does this to ensure that all collection activities by foreign ï?? ï?? ï?? ï?? Malaysia ratified the treaty on ï?? ï?? June , the ï?? ï?? th coun - researchers are properly and centrally monitored . These try to do so . records , upon request , will assist the States in carrying Implementation of the ï쳌£ ï쳌¢ ï쳌¤ is coordinated by ï쳌­ ï쳌¯ ï쳌³ ï쳌´ ï쳌¥ . out their own monitoring on such collection activities . ï쳌® ï쳌£ ï쳌¢ ï쳌¤ was established to carry out biological biodiver - Malaysians do not need to apply for permission from ï쳌¥ ï쳌° ï쳌µ ; sity planning and its implementation and subse - however , they do have to apply for relevant permits at the quently created the following : state level . Foreign bioprospectors also need to obtain the National Technical Committee on Biological necessary visa for conducting any research . Diversity In Peninsular Malaysia , one is required to have a permit ï쳌§ ï쳌­ ï쳌¡ ï쳌£ or license to prospect in the forest . Under the Forestry Act National Technical Committee on Biological Diversity of ï?? ï?? ï?? ï?? , two types of licenses can be issued . One type is established three Task Forces : for major forest products like timber , poles , fuel wood , Country Study on Biological Diversity National Policy on Biological Diversity charcoal , and manau and sega rattans . A minor license Access to Genetic Resources can also be issued for forest products other than those ï쳌§ ï쳌­ ï쳌¡ ï쳌£ established the Task Force on Biosafety . mentioned above . Under section ï?? of the same Act , the ï?? ï?? ï?? ï?? Country study on biological diversity was undertaken , State Forestry director is empowered by the State authority from June ï?? ï?? ï?? ï?? to August ï?? ï?? ï?? ï?? , by the World to control the removal of plants or resources from the for - Wildlife Fund ( ï쳌· ï쳌· ï쳌¦ ) , Malaysian Nature Society est . In general , all licenses will correspond to a boundary ( ï쳌­ ï쳌® ï쳌³ ) , Universiti Putra Malaysia ( ï쳌µ ï쳌° ï쳌­ ) and Institute demarcated on the ground . Licenses are usually issued of Strategic and International Studies ( ï쳌© ï쳌³ ï쳌© ï쳌³ ) of for a term of three to ï?? ï?? months and can be renewed from Malaysia ( following the guidelines set forth in the time to time . However , a license cannot be transferred and United Nations Environment Program Guidelines will be terminated upon the death of the license holder or for a Country Study on Biological Diversity ) . dissolution of the body granted the license . Applicants ï?? ï?? ï?? ï?? Country study on biological diversity entitled will have to pay charges , which may consist of royalties , â?? Assessment of Biological Diversity in Malaysia â?쳌 was published ( ï쳌­ ï쳌¯ ï쳌³ ï쳌´ ï쳌¥ ï?? ï?? ï?? ï?? ) . premiums , development fees , or administrative fees and these vary from State to State . Sarawak passed a State law in December to establish the Sarawak Biodiversity Council and the Sarawak Malaysian researchers will have to apply for a Use Biodiversity Center . Permit under section ï?? ï?? of the Act to carry out research ï?? ï?? ï?? ï?? National Policy on Biological Diversity was approved activities in a permanent forest reserve . For this , they have by Government in October , and officially launched to first submit a research proposal which the Forestry 3 on ï?? ï?? April ï?? ï?? ï?? ï?? . Department will study . Once approval is granted , certain ï?? ï?? ï?? ï?? Sabah passed a State law in November to establish conditions , normally parallel with State interests , will be the Sabah Biodiversity Council and the Sabah attached . In certain cases , there can be a joint expedition Biodiversity Center . with department staff . ï?? ï?? ï?? ï?? National Biodiversity and Biotechnology Council held In the State of Sabah , the â?? Guidelines for Plant its inaugural meeting in December Specimen / Botanical Collecting â?쳌 apply specifically to National Biotechnology Directorate under ï쳌­ ï쳌¯ ï쳌³ ï쳌´ ï쳌¥ collecting from areas under the Forestry Departmentâ??s established the Task Force on National Policy on jurisdiction or where special requirements necessitate Biotechnology in December . Forestry Department approval . With the enactment of the ï?? ï?? ï?? ï?? ï쳌­ ï쳌¯ ï쳌³ ï쳌´ ï쳌¥ is handling two draft legislative initiatives , Sabah Biodiversity Enactment ï?? ï?? ï?? ï?? and the subsequent namely the Biosafety Bill and the Access to Genetic Resources Bill . establishment of the Sabah Biodiversity Council , any The Ministry of Agriculture handled the Plant Variety collector who intends to obtain biological resources from Protection Bill , passed by Parliament . the State will now need to apply in writing to the Sabah ï?? ï?? ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ Biodiversity Council for an access license . In such cases , has become all the more significant in light of the renewed interest in natural and pharmaceutical permission from the Sabah Director of Forestry is required products derived from plant samples . An exception prior to collecting . Collectors are required to lodge a good to this general legislative omission is the Sarawak duplicate of any collection with the Forestry Department State legislation called the Wildlife Protection within ï?? ï?? days . When the field work is finished , collec - Ordinance ï?? ï?? ï?? ï?? , Protected Plants Listing . tors must submit a field report listing plants collected and their numbers . â?¢ Legislation related to the management and use of InApril ï?? ï?? ï?? ï?? , the state of Sarawak amended its Forests natural resources and natural habitats . There are a Ordinance to incorporate new controls on access to genetic number of statutes that provide for the management resources . The new provisions require any persons wishing of natural habitats and other critical areas such as to remove or export trees ( or any of their derivatives ) to water catchment areas and rivers . Existing legisla - acquire prior authorization from the Director of Forests tion which relates to the establishment and man - on the approval of the Minister of Forestry of Sarawak if agement of protected areas includes the National they intend to conduct research into pharmaceutical or ParksAct of ï?? ï?? ï?? ï?? in the Peninsula , the Sabah Parks medicinal compounds . The legislationâ??s coverage is lim - Enactment of ï?? ï?? ï?? ï?? , and the Sarawak National Parks ited to â?? trees â?쳌 . Thus , its main limitation is that it does not and Reserves Ordinance of ï?? ï?? ï?? ï?? . Such legislation cover biological diversity other than trees found in forests also provides for the protection and conservation or other habitats . of biological diversity found within the boundaries Currently , little information exists on the remain - of the parks . ing eleven States â?? positions on the issue of access to â?¢ Legislation which has indirect impact on biological genetic resources . Against the backdrop of the current diversity . An example is the Land Acquisition Act political situation , it is remotely possible that some of ï?? ï?? ï?? ï?? or the Town and Country Planning Act of of the eleven States may enact their own access laws . ï?? ï?? ï?? ï?? , in the sense that the acquisition of land or However , with the setting up of the National Biodiversity development in a particular area may threaten the and Biotechnology Council , which includes all Mentri biological diversity and the natural habitats which 4 Besar and Chief Ministers , the States may adopt and house such biological diversity . implement the new â?? Access to Genetic Resources Bill â?쳌 . The inclusion of all Mentri Besar and Chief Ministers in The Sarawak Research Permit System the Council is significant , since natural resources , such as forests , are under State jurisdiction . In any case , so In ï?? ï?? ï?? ï?? , the State of Sarawak proposed the idea of set - far , none of the Peninsular Malaysia states have adopted ting up a specific - purpose biodiversity center to enable unilateral measures like Sarawak and Sabah , which now Sarawak to protect more of its own biodiversity . The idea have their state laws in place through the enactment of was thoroughly debated over the next few years . The the Sarawak Biodiversity Center Ordinance in December debate culminated in late ï?? ï?? ï?? ï?? with the enactment of ï?? ï?? ï?? ï?? , the Sarawak Biodiversity ( Access , Collection and the Sarawak Biodiversity Center Ordinance ï?? ï?? ï?? ï?? . This Research ) Regulations in December ï?? ï?? ï?? ï?? , and the Sabah ordinance provided for the establishment of the Sarawak Biodiversity Enactment in November ï?? ï?? ï?? ï?? , respectively . Biodiversity Council in February ï?? ï?? ï?? ï?? and the birth of The proactive positions of the States of Sarawak and Sabah the Sarawak Biodiversity Center ( ï쳌³ ï쳌¢ ï쳌£ ) in July of the same are underscored by the fact that some of Malaysiaâ??s richest year . Consequently , ï쳌³ ï쳌¢ ï쳌£ will become the focal point for biodiversity is found in these two states , upon which their biodiversity inventory , monitoring research , education , indigenous communities still depend for their livelihood utilization , management , and conservation . and survival . Apart from being a focal point for biodiversity informa - As for nonspecific measures , there is a fairly extensive tion and related activities in Sarawak , ï쳌³ ï쳌¢ ï쳌£ is also charged framework of legislation for biological diversity conser - with the responsibility of regulating the access to , collec - vation , which may relate indirectly to access to genetic tion of , and research on Sarawakâ??s biological resources . resources . This framework can be broadly categorized To this end , in ï?? ï?? ï?? ï?? ï쳌³ ï쳌¢ ï쳌£ put in place a Research Permit into three types : System ( ï쳌² ï쳌° ï쳌³ ) which also ensures the conservation of the â?¢ Legislation directly related to the protection and Stateâ??s biodiversity , its sustainable use , and fair and eq - conservation of biological diversity with emphasis uitable benefit sharing from its use , in line with the three on the flora and fauna of the country . However , basic objectives of the ï쳌£ ï쳌¢ ï쳌¤ . As the ï쳌² ï쳌° ï쳌³ does not differenti - protection of plants is currently not provided for ate between commercial and noncommercial purposes , all in national legislation . The National Forestry Act scientists seeking access to genetic resources in Sarawak , of ï?? ï?? ï?? ï?? and the forest enactments of Sabah and whether local or foreign , have to go through this system Sarawak are intended to regulate and control the to apply to the relevant permits . harvesting of timber and other forest products , but The î?« î?© î?¬ provides for four types of permits : Research these are inadequate to cover the many species of Permit , Export Permit , Sales Permit for Protected Species , wild plants found in the country . This omission and Ethnobiological Permit ( Figure ï?? ) . The term â?? biologi - ï?? ï?? ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? ï?? : M ï쳌¡ ï쳌¬ ï쳌¡ ï쳌¹ ï쳌³ ï쳌© ï쳌³ ï쳌¡ cal resources â?쳌 as defined by the Ordinance includes any including the classification , indigenous nomenclature , con - extracts , whether in liquid or solid form , tissues , by - prod - servation techniques , and general sociological importance uct or derivative , or synthesized form thereof . In relation of such biological resources to them . to biological resources , the term â?? derivative â?쳌 includes their Before any permit may be granted for research on genetic and genomic form or material . The term â?? ethno - biological resources or for ethnobiological research , a biology â?쳌 means the knowledge or information pertaining research agreement must be entered into between the to the uses by the native peoples of the State of biological Government and the person or institution intending to carry resources for medicinal , food , health , or other purposes , out such research . A research agreement shall include , but Application for Permit Based on research , species which ( Prior approval , could be used for pharmaceutical or biotechnological development will be with specified conditions , designated as protected species . required for protected species ) 1 . Malaysian of Sarawak origin or Permanent Resident 2 . Malaysian corporations / Ministry of Education educational institutions 3 . Foreign corporations , educational institution , Access individuals require sponsor approved Council SBC Propagation , Signing of breeding , or Research Agreement cultivation of protected species Deposit specimen Access approved Sales Permit for Ethnobiological Protected Species Research Research Permit Permit 1 . Payments to natives as rewards for knowledge or information provided by Collection of Collection to be them , regardless of whether accompanied by Biological the research results in representative of SBC commercial development Resources Research of any medicinal or other product 2 . IPR or patent to be 1 . Research could not be shared with natives who undertaken within Sarawak supplied the knowledge or 2 . Corporations / individuals with information specified expertise / qualifications & with collection made through local sponsors Export 1 . Research to be undertaken in 3 . Submit data / report from Permit Sarawak unless with Councilâ??s research outside Sarawak approval 4 . Disclaim rights to IPR or patents 2 . Research data , finding , papers , in the event of discovery reports , and other information availble to SBC 3 . Access to research premises by SBC 4 . Allow scientists nominated by SBC to participate in research 5 . No publication or dissemination of information without approval Figure ï?? . The research permit system as stipulated by the Sarawak Biodiversity Center ( ï쳌³ ï쳌¢ ï쳌£ ) . Four types of permits are provided ( shaded hexagons ) . The solid lines designate the steps from application to receipt of permit and the un - dertaking which it allows . The dashed lines indicate information feedback pathways . The dotted boxes provide specific requirements or information needed at several steps . The unbounded text provides commentary on specific steps and results of the processes . ï?? ï?? ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ including rivers , tributaries , waterways or areas covered is not limited to the following : by water , marine parks , or territorial waters of the State , â?¢ The place or institution in Sarawak or outside as well as any ex situ collections maintained by the State . Sarawak where research is to be carried out ; There will be no export for research purposes of any bio - â?¢ Access by the Council to any reports , data , studies , logical resources without a license issued by the Council . or results of the research undertaken ; With the establishment of the Sabah Biodiversity Center â?¢ Rights of the Government to patents and intellectual in ï?? ï?? ï?? ï?? , it began taking on procedures for granting access property or over any discovery resulting from the permits in the State ( Figure ï?? ) . research undertaken , and where appropriate , the sharing of such rights with other parties in accor - National Level : dance with the research agreement ; The Access to Genetic Resources Bill â?¢ The rights of the Government to license any pat - ent or intellectual property and the entitlement to At the national level , the National Task Force on Access benefits derived therefrom ; to Genetic Resources was established by the National Technical Committee on Biological Diversity with the spe - â?¢ Confidentiality over any reports , data , studies , or cific mandate of addressing the issue of access to genetic results from such research ; resources ( Box ï?? ) . In drafting the countryâ??s future access â?¢ The transfer of technology , skills , and knowledge law and policy through a broad consultative process , the derived from such research , including the training Task Force was represented by agencies with responsibil - of scientists from the State , and their participation ity for the management of biodiversity in the country . In in such research ; general , the Task Force opted for developing the Access to â?¢ Ownership of data and results accruing from re - Genetic Resources Bill with wide consultative public input search ; and and with access requirements that are simple and clear , by â?¢ Other terms and conditions as may be mutually taking into consideration the following : agreed upon . â?¢ Promotion of local scientific research and de - For ethnobiological research , the permit holder may be velopment , i.e . , to reduce unnecessary potential required to make payments to native peoples as rewards constraints on local research and development ; for the knowledge or information provided by them in â?¢ Promotion of bioprospecting , in particular by pri - connection with the research . The payment may be made vate sector and multinational firms ; regardless of whether the research results in the com - â?¢ Provision of ample opportunities for participation mercial development of any medicinal or other products . by all stakeholders ; Where such research leads to the development of any pharmaceutical or medicinal compound or any health â?¢ Securing and maximizing practical and enforce - or nutritional product , the patent or intellectual property able sharing of benefits from the uses of biologi - right to such compound or product shall be shared with cal resources and associated traditional knowledge the native people . and traditions , with emphasis on conservation of biological resources and associated knowledge , financial benefits , research collaboration , and The Sabah Access License technology transfer ; In ï?? ï?? ï?? ï?? , Sabah passed the Sabah Biodiversity Enactment â?¢ Ensuring the practicality of prior informed consent ï?? ï?? ï?? ï?? and established the Sabah Biodiversity Council . As ( ï쳌° ï쳌© ï쳌£ ) procedures and benefit - sharing arrangements stipulated by the Enactment , any collector who intends with local communities ; to obtain biological resources shall apply in writing to â?¢ Ensuring that the emerging access regime is not the Sabah Biodiversity Council for an access license . overly bureaucratic ; and The application shall be in respect of access to biological â?¢ Ensuring adequate government administrative and resources found on : a ) State lands ; b ) any reserves , indig - technical capacities to implement the laws and the enous peoples â?? customary lands , or any other sites over access procedures with the relevant degree of which indigenous and local communities exercise com - munity - based or customary rights ; or c ) any other areas , centralization / decentralization . Analysis of the Process that Led to the Development of the Access to Genetic Resources Bill The process leading to the development of the Access to planning on biological diversity in Malaysia . The National Genetic Resources Bill is summarized in Table ï?? . The Technical Committee on Biological Diversity then estab - process really took off in ï?? ï?? ï?? ï?? , two years after the Rio lished the Task Force onAccess to Genetic Resources ( Box Summit , when the ï쳌® ï쳌£ ï쳌¢ ï쳌¤ was formed and began strategic ï?? ) . To assist the Task Force , the ï쳌¡ ï쳌§ played a pivotal role in ï?? ï?? ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? ï?? : M ï쳌¡ ï쳌¬ ï쳌¡ ï쳌¹ ï쳌³ ï쳌© ï쳌³ ï쳌¡ the revision of the law on access to genetic resources . The authority for each piece of legislation amended . Neither process was intensified and culminated in the organization did the process provide for a monitoring mechanism . of the National Workshop on Access and Benefit Sharing Benefit sharing was addressed only in terms of technol - of Genetic Resources in ï?? ï?? ï?? ï?? ( Box ï?? ) . ogy transfer and the collection of fees and payment of The Task Force finally recommended , after a reversal royalties . The distribution of benefits for the purposes of an earlier stance and in - depth deliberations , enactment of conservation and local community development was of a national ( Federal ) framework legislation that would not adequately considered . The amendments addressed be known later as the â?? Access to Genetic Resources Bill â?쳌 the issue of access and benefit sharing ( ï쳌¡ ï쳌¢ ï쳌³ ) at one level , applicable to the whole of Malaysia . Earlier , based on the but no clear linkages were drawn from the amendments recommendation of the ï쳌¡ ï쳌§ that no new legislation was to the objectives of conserving biological diversity and required to address the issue of bioprospecting , access , and equitable benefit sharing . Furthermore , in light of the vital benefit sharing , the approach was to consider amending contributions made by local and indigenous communities , three statutes , namely the National Forestry Act of ï?? ï?? ï?? ï?? , the protection of indigenous knowledge and innovations the Protection of Wildlife Act of ï?? ï?? ï?? ï?? , and the Fisheries becomes particularly relevant and needs to be addressed . Act of ï?? ï?? ï?? ï?? , by inserting new provisions relating to the Therefore , it was imperative that national legislation be establishment of a licensing system within the existing enacted that would guarantee consistency in approach to legislative provisions . The license ( or access license as it key issues , for the purpose of fulfilling obligations under is referred to in the amendments ) was meant to be a form the ï쳌£ ï쳌¢ ï쳌¤ , despite the fact that the Federal - State dichotomy of access control . However , the approach of amending issues at hand would still need to be resolved . each piece of legislation was too fragmented to ensure At one point in the process leading to the development a consistent approach . In addition , the process did not of the access law , the Task Force worked on the provision identify a single agency with the responsibility of admin - to establish a National Biodiversity Council responsible istering the licensing system . Instead , it imposed respon - for matters relating to access to genetic resources and also sibility on many agencies , depending on the responsible to the biosafety of genetically modified organisms ( ï쳌§ ï쳌­ ï쳌¯ s ) . Application for License State Council Cabinet SBC 1 . Shall not apply to public officers with no collaboration with second and third party . 2 . Individual , academic , and research Further information , institutions in pure academic and when required nonprofit research are exempt . 3 . Malaysian institution of Sabah origin as local collaborator . 4 . Foreign institution as sponsor . Evaluationion Appeal and decis Revocation process process Access licence Yes No approved or rejected Access license Figure ï?? . Access license application as stipulated by Sabah Biodiversity Enactment of ï?? ï?? ï?? ï?? . ï?? ï?? ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ This meant that that there would be three separate bills pleted in not less than one year . In the meantime , the Bill to be considered together , namely , one bill for access to was scheduled to go through the national consultative genetic resources , one bill for biosafety , and the third bill process in the years ï?? ï?? ï?? ï?? and ï?? ï?? ï?? ï?? , then to the Cabinet for establishing the institutional structure that would be for approval , and finally to the Parliament for the Bill responsible for administering and implementing the other to be passed into law . Be that as it may , the process has two bills ( Table ï?? ) . This approach , which would have cre - progressed at a relatively slower pace particularly with ated a colossal legal predicament , was proposed by the regard to national consultation . ï쳌­ ï쳌¯ ï쳌³ ï쳌´ ï쳌¥ is currently giving Task Force to ï쳌­ ï쳌¯ ï쳌³ ï쳌´ ï쳌¥ . It has now been decided that this priority to passing the Biosafety Bill into law in ï?? ï?? ï?? ï?? . approach will no longer be pursued , and two of the bills Therefore , the process of completion and adoption by the ( i.e . , access and biosafety ) , each with its own institutional government of the Access to Genetic Resources Bill will infrastructure , will now be tabled separately . now extend beyond ï?? ï?? ï?? ï?? . The responses from the different Five years after its establishment , the Task Force of - States , in particular Sarawak and Sabah , are crucial for the ficially completed its task when it adopted the final text completion and adoption of the access law . of the Access to Genetic Resources Bill in October ï?? ï?? ï?? ï?? . It should be noted that while the above process was The whole process from the final draft to the passing of taking place at the Federal level , the states of Sarawak the Bill into law would be handled by ï쳌­ ï쳌¯ ï쳌³ ï쳌´ ï쳌¥ , in close and Sabah had their own processes underway , and these collaboration with the ï쳌¡ ï쳌§ and was expected to be com - culminated in the enactment of the Sarawak Biodiversity Box 1 . Task Force on Access to Genetic Resources Pursuant to the decision of the National Committee on industries , and ï쳌® ï쳌§ ï쳌¯ s , and to obtain feedback from them . A Biological Diversity , the Task Force was set up to review or national consultative process was also initiated in early ï?? ï?? ï?? ï?? revise the relevant Malaysian laws to meet Malaysiaâ??s ï쳌£ ï쳌¢ ï쳌¤ and all States and relevant stakeholders had been asked for obligations . One of the important areas identified by the Task their responses and for feedback on the final draft . Force for urgent revision relates to access to genetic resources The work of the Task Force can be summarized as occur - as addressed underArticle ï?? ï?? of ï쳌£ ï쳌¢ ï쳌¤ to ensure that Malaysiaâ??s ring in two phases : interest under the Article is fully protected . Phase One : Amendment of Existing Sectoral Legislation The Task Force membership included representatives from and Enactment of a Separate Legislation to Address the theAttorney Generalâ??s Chambers ; ï쳌­ ï쳌¯ ï쳌³ ï쳌´ ï쳌¥ ; Forest Department ; Gaps or Loopholes Applicable to Peninsular Malaysia . Department of Agriculture ; Wildlife Department ; Fisheries The Task Force started its review with a focus on legal mecha - Department ; Veterinary Department ; research institutions ; nisms already available within Malaysiaâ??s legal framework . universities ; representatives from the states of Pahang , It further restricted its review to laws applicable only to Perak , and Sarawak ; and representatives from ï쳌® ï쳌§ ï쳌¯ s such as Peninsular Malaysia , since the relevant laws in Sabah and the Third World Network . With regard to biotechnology , a Sarawak are separate from the relevant laws in Peninsular representative from the National Biotechnology Directorate Malaysia . Based on the framework of existing laws , the re - under ï쳌­ ï쳌¯ ï쳌³ ï쳌´ ï쳌¥ and a number of researchers from several re - view would address , on a component by component basis , the search institutions and universities also sat in as members of following : forests , fisheries , wild animals , domestic animals , the Task Force . agrobiodiversity , and microorganisms . Subsequently , it was There was no direct representation from the indigenous considered whether , based on the results of the review , the and local communities in the Task Force ; however , their inter - necessary legal requirements relating to access to genetic ests were represented by the relevant ministries and agencies . resources could be incorporated separately but uniformly into ï쳌³ ï쳌¢ ï쳌£ was especially very helpful , since it is directly involved relevant existing laws , e.g . , the National Forestry Act of ï?? ï?? ï?? ï?? with various indigenous and local communities in Sarawak , or the Protection of Wildlife Act of ï?? ï?? ï?? ï?? . These revised laws and since the end of ï?? ï?? ï?? ï?? , it has been administering and would then provide strict legal mechanisms for protection of implementing the Sarawak Biodiversity ( Access , Collection genetic resources found in Malaysia and should legally reflect and Research ) Regulations of ï?? ï?? ï?? ï?? . the various requirements under Article ï?? ï?? of the ï쳌£ ï쳌¢ ï쳌¤ : access In the course of undertaking its task , the Task Force had to genetic resources based on ï쳌° ï쳌© ï쳌£ , mutually agreed terms , par - consultations with all the states in Peninsular Malaysia and ticipation in research and development by parties providing Sabah and Sarawak , taking into consideration different and the genetic resources , and equitable sharing of benefits arising ad hoc concerns pertaining to various issues relating to the from commercial use and utilization of genetic resources and ï쳌£ ï쳌¢ ï쳌¤ in general , and issues on access to genetic resources in the results of research and development on them . particular . With ï쳌­ ï쳌¯ ï쳌³ ï쳌´ ï쳌¥ providing administration , the Task Having undertaken this initial review exercise , the Task Force held a series of meetings from ï?? ï?? ï?? ï?? through ï?? ï?? ï?? ï?? . Force came to several conclusions presented in the following In ï?? ï?? ï?? ï?? , the Task Force sent the draft Bill to all States and paragraphs along with the current implementation status of requested their comments in writing . In ï?? ï?? ï?? ï?? , ï쳌­ ï쳌¯ ï쳌³ ï쳌´ ï쳌¥ orga - each of them : nized a consultative workshop on access and benefit sharing â?¢ Based on the relevant existing laws , the Task Force found to explain the draft Bill to various ministries and agencies that the requirements under Article ï?? ï?? could be incor - with responsibilities for the management of biodiversity in the country , including representatives from private sector , porated into existing laws for only some components of ï?? ï?? ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? ï?? : M ï쳌¡ ï쳌¬ ï쳌¡ ï쳌¹ ï쳌³ ï쳌© ï쳌³ ï쳌¡ Center Ordinance of ï?? ï?? ï?? ï?? and the Sabah Biodiversity â?¢ Promoting uniformity of the laws of the States ; Enactment of ï?? ï?? ï?? ï?? . â?¢ Intersections with other areas of law ; â?¢ Ensuring that access legislation meets all objectives Identification and Analysis of the Main of the ï쳌£ ï쳌¢ ï쳌¤ and is consistent with national priorities ; Difficulties and Successes Experienced â?¢ Establishing the institutional structure for the during the Design of the Access to Genetic implementation of the law ( including the idea of Resources Bill an umbrella institution to be responsible for both access to genetic resources and biosafety , which Many issues and questions experienced during the design turned out to be unworkable . of the Access to Genetic Resources Bill still remain un - â?¢ Obtaining model laws to serve as templates or as resolved . Therefore , considerable efforts are still needed sources of useful rules and principles to guide the before the access Bill is adopted by all States and passed development of access regime ; into law . These were the main difficulties : â?¢ Establishing / designating appropriate competent â?¢ Determining the authority ( Federal - State dichoto - authorities with a clear mandate to determine mat - my ) to legislate on matters relevant to biological diversity ; ters related to access and benefit sharing , e.g . , inter - Box 1 . Continued biodiversity : the Animal Ordinance of ï?? ï?? ï?? ï?? for domestic to genetic resources found in Malaysia , the Task Force animals ; the Protection of Wildlife Act of ï?? ï?? ï?? ï?? for wild was of the view that this should be approached on two animals ; the National ForestryAct of ï?? ï?? ï?? ï?? for forests ; and levels : First , a mandatory statutory requirement should be the Fisheries Act of ï?? ï?? ï?? ï?? for fisheries . In other words , the imposed on persons gaining access to genetic resources in only components of Malaysiaâ??s biodiversity that could Malaysia to obtain a prescribed form of license under the be addressed under the present legal framework for the law , whether or not such access relates to collection , use , purposes of ï쳌£ ï쳌¢ ï쳌¤ Article ï?? ï?? were these four . While a na - export , or research of the genetic resources in question . tional ( Federal ) framework law applicable to the whole Second , a separate contractual mechanism ( as opposed of Malaysia was also being considered , the Task Force to the statutory offenses mechanism ) should be imposed took cognizance of the gaps or loopholes in these laws whereby any persons intending to gain access to genetic re - that would need to be addressed . sources in Malaysia must enter into an agreement with the Government of Malaysia regulating activities with respect â?¢ With respect to agrobiodiversity , the Task Force found to the collection , use , export , or research of the genetic that existing relevant laws were inappropriate for the resources . Both mechanisms were incorporated in the draft purposes of incorporating ï쳌£ ï쳌¢ ï쳌¤ Article ï?? ï?? requirements , Access to Genetic Resources Bill . Any collector seeking especially after taking into account , with respect to plant an access activity is required to apply for an access license varieties , the various on - going international developments and also to enter into a separate contractual agreement . In ( i.e . , ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ , the revision of the International Union for the this manner , apart from being able to impose sanctions as Protection of New Varieties of Plants agreement , and the provided for in the governing statute , sanctions in the form revision of the International Undertaking on Plant Genetic of breach of contract can also be imposed . Resources ) . Therefore , the Task Force felt that this matter would be best addressed in a new and separate law so as to â?¢ Further , the Task Force was of the view that although be consistent with these developments and to ensure that these mechanisms must be incorporated separately into the the new law would address the totality of issues relating various laws , sufficient uniformity in its format to ensure to plant varieties . So , the draft Plant Variety Protection basic principles and requirements ( such as ï쳌° ï쳌© ï쳌£ , equitable Bill was proposed . sharing of benefits arising from commercial use and utilization , and results of research and development of â?¢ With regard to microorganisms , the Task Force found that genetic resources , and participation of parties in research existing legislation relating to plants and animals could not and development ) should be embodied . With respect to be readily extended to implement the requirements under ensuring sufficient uniformity for the above mechanisms ï쳌£ ï쳌¢ ï쳌¤ Article ï?? ï?? . This is because of the different nature of when incorporating them into the various laws , this would microorganisms , as opposed to plants and animals per be addressed by the draft Access to Genetic Resources se , and the finding that microorganisms have never been Bill . legislated upon in any manner in Malaysia . The Task Force felt therefore that it would best to embody the Article ï?? ï?? â?¢ Consistent with the Task Forceâ??s approach to impose strict requirements regarding access to microorganisms in a legal requirements to protect genetic resources , the Task separate law . Therefore , the issue of microorganisms Force took note of ï쳌¥ ï쳌° ï쳌µ â?? s efforts to formulate a new set of would be addressed by the national Access to Genetic guidelines relative to research and was of the view that Resources Bill . the imposition of these guidelines would be insufficient â?¢ In order to formulate strict legal mechanisms for access for the purposes of ï쳌£ ï쳌¢ ï쳌¤ Article ï?? ï?? because they were not ï?? ï?? ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ agency composition , monitoring and enforcement benefit sharing to an access agreement ; of compliance ; â?¢ Determining the nature of traditional knowledge and innovations to be covered under the scope of â?¢ Establishing competent authorities / negotiating the application as mandated by Article ï?? ( j ) and partners to take account of the interests of the related provisions ; holders of indigenous / traditional knowledge ; â?¢ Ensuring access regulations that will not hinder â?¢ Determining the nature of biological resources to basic noncommercial research , e.g . , education and be covered under the scope of the application , e.g . , taxonomy ; and derivatives of biological resources and their asso - â?¢ Promoting fairness and equity to a wide range ciated intangible components ; culture collections ; of relevant stakeholders in developing the access migratory species ; and resources collected before measures . the ï쳌£ ï쳌¢ ï쳌¤ came into force and stored in ex situ col - lections ; The main successes included : â?¢ Adequate participation of the holders of indigenous / â?¢ A comprehensive Bill was designed to regulate traditional knowledge or their representative orga - access to genetic resources rather than simplify - nizations in the development of appropriate terms ing or amending existing sectoral laws ( i.e . , if the of access , such as determining the ï쳌° ï쳌© ï쳌£ process and ï쳌£ ï쳌¢ ï쳌¤ is to have any practical impact , it needs to be Box 1 . Continued legally binding . Currently , there is little information on revision of laws should not require any amendments to the proposal or on progress by ï쳌¥ ï쳌° ï쳌µ to formulate a new the Federal Constitution , and this was to be done in ac - set of guidelines relative to research . However , pending cordance with the respective legislative authorities of the the conclusion of revision and amendment of laws , ï쳌¥ ï쳌° ï쳌µ â?? s Federal and State Governments , as appropriate , as stipu - Guidelines on Research should be adopted immediately lated under Article ï?? ï?? of the Ninth Schedule . as a temporary measure for the protection of genetic Phase Two : Enactment of a National ( Federal ) Framework resources found in Malaysia . The ï쳌¥ ï쳌° ï쳌µ â?? s Guidelines on Legislation Applicable to the Whole of Malaysia Research are still in force as a continuing measure of The preliminary findings of the Task Force ( Phase One ) were protection of genetic resources found in Malaysia . presented to the National Committee on Biological Diversity â?¢ The Task Forceâ??s general conclusion was that both the before the launch of the National Policy on Biological revision and amendment of existing laws with respect to Diversity in ï?? ï?? ï?? ï?? . Important objectives of the policy are the wild animals , domestic animals , forests , and fisheries , and optimization of economic benefits through the sustainable the setting up of new laws with respect to agrobiodiver - sity and microorganisms in the manner suggested above , utilization of biological diversity and the identification of would fully address Malaysiaâ??s concerns regarding access biodiversity prospecting activities as a priority . to genetic resources in the context of Article ï?? ï?? . The set - The National Committee sought to appraise the adequacy ting up of new laws with respect to agrobiodiversity and of the measures which would be undertaken to implement the microorganisms to address the gaps or loopholes arising policy objectives on access and benefit sharing as stated in the from the existing sectoral laws became unnecessary since National Policy on Biological Diversity . First , the National the Access to Genetic Resources Bill was proposed . Committee was of the opinion that there was an absence â?¢ The Task Force further noted that Sabah and Sarawak have of an integrative approach across sectors due to the limited separate laws on forests and animals , and in the case of scope of various enactments in relation to the overall objec - Sarawak , its laws have already been updated to meet the tives of biological diversity conservation . Second , the areas ï쳌£ ï쳌¢ ï쳌¤ â?? s Article ï?? ï?? requirements . The Task Force welcomed of jurisdiction of Federal and State governments as defined this effort by the State of Sarawak , but noted that where in the Constitution would lead to nonuniform implementa - the relevant laws in these States had not been updated , it tion between States . Consequently , the National Committee would be useful for these States to continue participating in decided that Malaysiaâ??s interests under ï쳌£ ï쳌¢ ï쳌¤ Article ï?? ï?? would the Task Force so as to achieve consistency and uniformity , be fully realized and protected only if a national ( Federal ) where possible . However , it should be noted that with the framework legislation applicable to the whole of Malaysia enactment of the Sarawak Biodiversity Center Ordinance were to be legislated . of ï?? ï?? ï?? ï?? and the Sabah Biodiversity Enactment of ï?? ï?? ï?? ï?? , With the new guidance provided for by the policy change many relevant laws on forests and animals have already intervention , the Task Force continued to progress on the draft been updated to meet the ï쳌£ ï쳌¢ ï쳌¤ â?? s Article ï?? ï?? requirements . access law , and to incorporate the legislative provisions to pro - â?¢ The Task Force also noted that implementing the revi - mote and enforce these objectives on a nationwide basis . The sion of laws was to be done in accordance with the draftAccess to Genetic Resources Bill was finally adopted by respective legislative authorities of the Federal and State the Task Force in October ï?? ï?? ï?? ï?? and subsequently presented Governments , as appropriate , as specified in the Federal Constitution . The Task Force was of the opinion that the to ï쳌­ ï쳌¯ ï쳌³ ï쳌´ ï쳌¥ for further deliberations and actions . ï?? ï?? ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? ï?? : M ï쳌¡ ï쳌¬ ï쳌¡ ï쳌¹ ï쳌³ ï쳌© ï쳌³ ï쳌¡ translated into national law and then enforced ) . â?¢ A system of community intellectual rights was pro - posed for the purpose of : a ) recognition of owner - â?¢ A system of cooperation between the Competent ship rights of communities over their knowledge 6 Authorities of the Federal and State Governments and innovations , b ) protection of the communities â?? was proposed to ensure uniformity in the adminis - knowledge and innovations , and c ) ensuring that tration of the law . an equitable share of benefits arising from use of â?¢ Biotechnology and biodiversity prospecting , hav - such knowledge is channeled back to the com - ing considerable potential to add value to specific munities . ( This system was discussed but due to biological / genetic resources , have been given prior - its controversial nature it was not taken on board ity and will increasingly become strategic factors in the Access to Genetic Resources Bill . However , in the near future . the discussion of the system can be considered as â?¢ A distinction was made between academic research one of the successes of the process . ) and commercial bioprospectors . â?¢ The elements of a community intellectual rights â?¢ A system of mandatory licenses for access and ac - system were determined , such as : a ) identifica - cess agreements between parties , containing mini - tion of recognized community intellectual rights , mum terms concerning the provision of information including setting up a system of collection and and samples , technology cooperation , and benefit registration of traditional knowledge and innova - sharing , was developed . tions , b ) criteria , mechanisms , and procedures for Table ï?? . Process leading to the development of the Access to Genetic Resources Bill â?¢ ï쳌® ï쳌£ ï쳌¢ ï쳌¤ , established in ï?? ï?? ï?? ï?? , in turn established the ing process ) was expected to be ready in ï?? ï?? ï?? ï?? . National Technical Committee on Biological Diversity â?¢ South and Southeast Asia Regional Workshop on Access and ï쳌§ ï쳌­ ï쳌¡ ï쳌£ . to Genetic Resources and Traditional Knowledge was â?¢ The National Technical Committee on Biological held in Chennai , India , ï?? ï?? â?? ï?? ï?? February ï?? ï?? ï?? ï?? , with Diversity established in ï?? ï?? ï?? ï?? the Task Force on Country Malaysian participation . Study on Biological Diversity , the Task Force on â?¢ National Policy on Biological Diversity was launched on National Policy on Biological Diversity , and the Task ï?? ï?? April ï?? ï?? ï?? ï?? . Force on Access to Genetic Resources . â?¢ Sarawak Biodiversity Center was established , July ï?? ï?? ï?? ï?? . â?¢ A Country Study on Biological Diversity was undertaken â?¢ Sarawak Biodiversity ( Access , Collection and Research ) by ï쳌© ï쳌³ ï쳌© ï쳌³ , ï쳌­ ï쳌® ï쳌³ , ï쳌· ï쳌· ï쳌¦ Malaysia , and ï쳌µ ï쳌° ï쳌­ , June ï?? ï?? ï?? ï?? â?? July Regulations were enacted in December ï?? ï?? ï?? ï?? . ï?? ï?? ï?? ï?? . A Task Force , jointly coordinated by Universiti â?¢ A meeting on the ï쳌¡ ï쳌³ ï쳌¥ ï쳌¡ ï쳌® Framework Agreement on Kebangsaan Malaysia ( ï쳌µ ï쳌« ï쳌­ ) and Forest Research Access to Genetic Resources was organized by the Institute Malaysia ( ï쳌¦ ï쳌² ï쳌© ï쳌­ ) , which reported to the National Department of Environment and Natural Resources of the Technical Committee on Biological Diversity , was Philippines and the World Resources Institute ( ï쳌· ï쳌² ï쳌© ) , ï쳌µ ï쳌³ ï쳌¡ , responsible for overseeing the preparation of the docu - 5 ï?? â?? ï?? December ï?? ï?? ï?? ï?? ; Malaysia could not participate . ment entitled â?? Assessment of Biological Diversity in â?¢ Consultation took place with all States on ï쳌¡ ï쳌¢ ï쳌³ issues Malaysia â?쳌 ( ï쳌­ ï쳌¯ ï쳌³ ï쳌´ ï쳌¥ ï?? ï?? ï?? ï?? ) . throughout ï?? ï?? ï?? ï?? . â?¢ The Task Force on Access to Genetic Resources held meetings from ï?? ï?? ï?? ï?? through ï?? ï?? ï?? ï?? . â?¢ ï쳌® ï쳌£ ï쳌¢ ï쳌¤ rendered a decision in ï?? ï?? ï?? ï?? with a new direction : To enact a national ( Federal ) framework legislation ap - â?¢ The meeting â?? Guidelines to facilitate access to biologi - plicable to the whole of Malaysia . cal resources and the equitable sharing of benefits in the South East Asian Region â?? was organized by ï쳌µ ï쳌® ï쳌¥ ï쳌³ ï쳌£ ï쳌¯ and â?¢ Final text of Access to Genetic Resources Bill was adopt - the Malaysian Natural Products Society and held ï?? â?? ï?? ed in October ï?? ï?? ï?? ï?? . April ï?? ï?? ï?? ï?? . â?¢ First Meeting of Panel of Experts on ï쳌¡ ï쳌¢ ï쳌³ took place in â?¢ National Workshop on Access and Benefit Sharing of Costa Rica , October ï?? ï?? ï?? ï?? with Malaysian participation . Genetic Resources , ï?? â?? ï?? August ï?? ï?? ï?? ï?? , produced an as - â?¢ The International Conference â?? Biodiversity ï?? ï?? ï?? ï?? â?쳌 , took sessment of national needs and opportunities with regard place in Kuching , Malaysia , ï?? â?? ï?? November ï?? ï?? ï?? ï?? . to access and benefit sharing initiatives , adopted the â?¢ The Sabah Biodiversity Enactment occurred in direction of amending existing sectoral legislation , and November ï?? ï?? ï?? ï?? . discussed the model agreement for biodiversity prospect - â?¢ Consultation with ministries / agencies responsible for ing and reviewed the provisions of the draft Agreement the management of biodiversity , and industries on ï쳌¡ ï쳌¢ ï쳌³ , for Research , Collection and Utilization of Biological / Malaysian Center for Remote Sensing , Kuala Lumpur , Genetic Resources for Environmentally Sound Uses ï?? ï?? December ï?? ï?? ï?? ï?? ( drafted by ï쳌¡ ï쳌§ ) . â?¢ Second Meeting of Panel of Experts on ï쳌¡ ï쳌¢ ï쳌³ , Montreal , â?¢ â?? Assessment of Biological Diversity in Malaysia â?쳌 was March ï?? ï?? ï?? ï?? ( Malaysia participated ) published in ï?? ï?? ï?? ï?? . â?¢ The Sabah Biodiversity Center was established in ï?? ï?? ï?? ï?? . â?¢ The Sarawak Biodiversity Center Ordinance was adopted December ï?? ï?? ï?? ï?? . â?¢ Ad Hoc Open - Ended Working Group on ï쳌¡ ï쳌¢ ï쳌³ met in Bonn , â?¢ The National Wetland Policy ( currently still in the draft - Germany , October ï?? ï?? ï?? ï?? with Malaysian participation . ï?? ï?? ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ implementing the system , c ) identification of tech - and indigenous and local communities , and g ) fi - nancial benefits of various forms ( e.g . , collection nical institutions , and d ) registration of indigenous fees , payments of agreed sums at various stages , and local community organizations . and royalties ) . 7 â?¢ Types of benefits were specified to include : a ) voucher specimens , b ) support for conservation Issues that were Controversial during the and related activities , c ) participation / collaboration Discussions of nationals in research , d ) sharing of research and Ownership of Genetic Resources : development results , e ) effective access and transfer of technology , f ) capacity building of institutions â?¢ Access to biological resources found on public Box 2 . National Workshop on Access and Benefit Sharing of Genetic Resources : International Imperatives and National Needs ( MOHAMAD 1997 ) This workshop was organized in August ï?? ï?? ï?? ï?? by the Genetics authority over genetic resources . The workshop agreed that the Society of Malaysia and ï쳌µ ï쳌« ï쳌­ , on behalf of the National constitutional issues should be examined further to explore the Committee on Biological Diversity and the Task Force on possibility for new legislation . In this context , the workshop Access to Genetic Resources in collaboration with the ï쳌· ï쳌² ï쳌© . identified a number of options that could be considered : The objectives of the workshop were to : ï?? ) formulate national â?¢ Enacting a national ( Federal ) framework law applicable to responses to ï쳌£ ï쳌¢ ï쳌¤ articles ï?? ï?? , ï?? ï?? and ï?? ï?? ; ï?? ) review existing Peninsular Malaysia ; national legislation with respect to access and benefit - sharing ; â?¢ Enacting a national ( Federal ) framework law applicable to and ï?? ) review current initiatives in neighboring countries and the whole of Malaysia ; other regions of the world while assessing the existing inter - â?¢ Amending existing sectoral legislation and enacting a national situation on genetic resources utilization . separate law to address the gaps or loopholes ; and The workshop participants included representatives â?¢ Enacting model state legislation for the individual states from government agencies , universities , and NGOs . to adopt . Representatives from the ï쳌· ï쳌² ï쳌© , the World Conservation Union The workshop also discussed the elements which should ( ï쳌© ï쳌µ ï쳌£ ï쳌® ) Environmental Law Center , and the Royal Botanic be included in legislation for access and benefit sharing , such Gardens , Kew , also attended the workshop as resource per - as a definition of genetic / biological resources , the problem sons . The workshop was an awareness - raising consultative of administrative authority , enforcement issues , and consti - process involving the various stakeholders at the national level . tutional issues . Recommendations for developing the legal and institutional framework for access and benefit sharing in Malaysia were A model agreement for biodiversity prospecting discussed and three issues were identified as targets . The workshop agreed that a model agreement would be an im - Assessment of needs and opportunities portant element within the framework for regulating biodiver - The workshop agreed that there was a need for a comprehen - sity prospecting activities . It would ensure minimum standards sive assessment of the current situation in the country with and facilitate benefit - sharing arrangements . Legislation might regard to access and benefit - sharing initiatives . The objective be able to provide minimum standards , but a further set of of such a measure would be to assess the needs , opportuni - standards could be incorporated into biodiversity prospecting ties , resources , and capacities in the country . The assessment agreements.As for benefit sharing , while the general character could comprise surveys and consultations to ï?? ) identify needs of benefits can be specified in legislation , specific agreements and priorities ; ï?? ) assess industry demand ; ï?? ) identify market can spell out a detailed list of benefits and other operational opportunities ; and ï?? ) document biodiversity prospecting ac - aspects . It was also agreed that while a model agreement would tivities . An assessment would also create awareness on issues provide a useful basis for negotiations , it should not be looked relating to biodiversity prospecting , access , and benefit - shar - upon as a rigid prescription but rather as a checklist of items ing . The assessmentâ??s findings would then form the basis upon for consideration . With these points in mind , the workshop which a national strategy for biodiversity prospecting could reviewed the provisions of the draft Access Agreement for be formulated . Research , Collection and Utilization of Biological / Genetic Resources for Environmentally Sound Uses ( drafted by the Access and benefit - sharing legislation ï쳌¡ ï쳌§ ) . A list of provisions to be reconsidered was compiled to The primary concern about legislation relating to access and forward to the ï쳌¡ ï쳌§ for further action . The draft is apparently benefit sharing was the Federal - State system in Malaysia . The constitutional dichotomy raises the issue of legislative still under consideration by the ï쳌¡ ï쳌§ . ï?? ï?? ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? ï?? : M ï쳌¡ ï쳌¬ ï쳌¡ ï쳌¹ ï쳌³ ï쳌© ï쳌³ ï쳌¡ lands belonging to Federal / State governments ; â?? Cells , genes , or copies of genes ; â?¢ Access to biological resources found on lands where â?? Biological and microbiological processes for ownership rights are communal or customary ; production of plants and animals ; and â?¢ Access to traditional knowledge and innovations ; â?? Traditional knowledge and innovations . and The above are the three major issues that are being ad - â?¢ Pre - ï쳌£ ï쳌¢ ï쳌¤ ex situ collections . dressed by theAccess to Genetic Resources Bill . There are Indigenous Knowledge and Innovations : many questions surrounding them , especially the last two â?¢ Establishment of a system of community intellec - issues . These important questions still remain unresolved , tual rights and not only at the national ( inter - ministerial ) level , but also at â?¢ Elements of community intellectual rights . the international level . The need for quick action should Intellectual Property Rights : form part of the national implementation process of the ï쳌£ ï쳌¢ ï쳌¤ ; however , such action must be balanced by the need â?¢ Exclusive or monopoly ownership rights exercised for a well - thought - out policy which meets the objectives over biological / genetic resources and traditional knowledge / innovations . of conservation , development , and equity . Lately , because of these reasons , there was even a proposal to reduce the â?¢ Exclusion of intellectual property rights , such as patents over : scope of the present Access to Genetic Resources Bill . In other words , quick action might be achieved by concentrat - â?? Plants , animals , microorganisms , or parts thereof ; ing only on access licensing and benefit sharing . Access to Genetic Resources Bill ( The Future Access Law ) Based on federal law , if the Access to Genetic Resources ( public officers and researchers ) , Relation to other Acts , Bill is adopted and implemented at the federal level , then Regulations , and Transitional provisions . Thus far , the is - all the Sarawak access regulations , the Sabah guidelines , sue of funding for the implementation of the access Bill and other state laws will have to be modified accordingly . has not been discussed . However , the expeditious passage of such modifications Interpretation / Meaning of Terms will largely be determined by the political will at the State The term â?? access â?쳌 will include all activities relating to pros - level . The Access to Genetic Resources Bill will also have pecting , collection , commercial utilization , and research to consider the interests of Sarawak and Sabah regarding and development of biological resources or the associated access to their genetic resources ; however , at the same relevant community knowledge and innovations . Terms time it is important that the Bill is in line with the spirit such as biological resources , genetic resources , genetic and provisions of the ï쳌£ ï쳌¢ ï쳌¤ . material , in situ conditions will be as defined in Article ï?? of the ï쳌£ ï쳌¢ ï쳌¤ . The term â?? biological resources â?쳌 will include Main Parts of the Bill genetic resources , organisms or parts thereof , populations , or any other biotic component of ecosystems with actual or The components consist of Preamble , Preliminary ( title , potential use or value for humanity . Biological resources application , commencement , savings , and interpretation / in ex situ collections will include those resources and their meaning of terms ) , Objectives , Scope , License for access , components that are conserved outside their natural habi - Access application , Evaluation of application , Decision - tats such as in herbariums , research institutions , universi - making procedure , Conditions for approval ( terms of access ties , botanical gardens , and any other similar conservation license , endorsement of access agreement , assignment , and centers , while biological resources in in situ conditions terms of access agreement ) , Disclosure of information to will include those resources that exist within ecosystems the public , Review of decision , Monitoring and enforce - and natural habitats , and in the case of domesticated or ment ( authorities , powers of entry and investigation ) , cultivated species , in the surroundings where they have Costs , Appeals , Offenses , Institutional structure ( compe - developed their distinctive properties . The term â?? genetic tent authority ) , Traditional knowledge ( ownership , proof resources â?쳌 means genetic material of actual or potential of ownership , co - ownership , system of protection of tradi - value , and the term â?? genetic material â?쳌 means any mate - tional knowledge , system of records of traditional knowl - rial of plant , animal , microbial or other origin containing edge , technical institutions , registration of indigenous and functional units of heredity . local community organizations ) , Prior informed consent , The term â?? community knowledge and innovations â?쳌 Fair and equitable sharing of benefits / agreements ( types will include the knowledge , innovations , and practices of of benefits , mechanisms for sharing of benefits arising indigenous and local communities associated with any from traditional knowledge ) , Intellectual property rights biological resource or any part thereof with regard to its ( nonpatentability , limitations , certificate of origin , ï쳌° ï쳌© ï쳌£ , and compulsory licenses ) , Exemptions / Nonapplicability use , properties , values , and processes in various forms , ï?? ï?? ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ whether written , spoken , narrative or anecdotal . at the international level . For example , when developing the Bonn Guidelines on Access to Genetic Resources Scope and Fair and Equitable Sharing of the Benefits Arising The draft law stipulates that access to genetic resources out of their Utilization which was adopted in ï?? ï?? ï?? ï?? by must be limited to the clear biological and geographical the Ad Hoc Open - ended Working Group on Access and boundaries as defined by the Government . It is intended Benefit Sharing , one of the obstacles to progress , which to regulate the access of biological resources found on remains unresolved , is the question of the kind of genetic public lands , communal or customary lands , and alienated resources and their benefits to be covered in the scope of or private lands , as follows : the Guidelines . â?¢ Public lands , which either belong to the State or Federal governments or come under their juris - Ex Situ Collections . As previously discussed , the draft diction ( e.g . , forest , wildlife reserves , parks , and legislation to regulate access does not include in its scope marine parks ) ; ex situ botanical collections and seed banks that had al - â?¢ Communal or customary lands , where the indig - ready been available pre - ï쳌£ ï쳌¢ ï쳌¤ ( See Box ï?? for examples ) . enous and local communities have the ownership Ex situ collections that were procured from other parties rights which are collective or communal or based on after ï?? ï?? December ï?? ï?? ï?? ï?? are addressed by the proposed custom ( e.g . , native customary lands and aboriginal law and are included within its scope . However , it remains reserves ) ; and unclear how the various issues surrounding the pre - ï쳌£ ï쳌¢ ï쳌¤ ex situ collections could be expeditiously resolved , at both â?¢ Alienated or private lands , which are lands held un - national and international levels . der individual title or by another legal proprietor . In Malaysia , ex situ conservation activities of various The law will also regulate access to community knowl - plant genetic resources are carried out in aboreta , seed edge and innovations associated with the biological re - genebanks , field genebanks , and in vitro genebanks or sources . It also preserves the rights of indigenous and local under cryopreservation . Based on a survey in ï?? ï?? ï?? ï?? , it communities to continue with their traditional customary was estimated that ï?? ï?? , ï?? ï?? ï?? accessions of plant genetic practices of use , exchange , and marketing of biological material were in ex situ collections of various institutions resources . As an exemption , the draft law prohibits access in Malaysia , inclusive of both indigenous and introduced to human genetic resources . plant species . The most established and common form of It is therefore apparent that the scope , as described ex situ genetic resource collections in Malaysia is through above , is intended to cover biological resources and asso - the establishment of plants in arboreta . These can be found ciated community knowledge and innovations as defined , in arboreta of many research institutions . In Peninsular with the exclusion of human genetic resources . This will Malaysia , the major arboreta are found in ï쳌¦ ï쳌² ï쳌© ï쳌­ , Rimba impinge on many industries , i.e . , the draft law will regulate Ilmu in Universiti Malaya , Medicinal Plant Garden at access to genetic resources pertaining to agriculture , bo - ï쳌µ ï쳌° ï쳌­ , Orchid Collection in the Malaysian Agricultural tanical medicine , biotechnology , and pharmaceutical prod - Research and Development Institute ( ï쳌­ ï쳌¡ ï쳌² ï쳌¤ ï쳌© ) and in Penang ucts . As will be discussed later , the Sarawak Biodiversity Botanical Garden . In Sabah , ex situ collections include the ( Access , Collection and Research ) Regulations of ï?? ï?? ï?? ï?? , for Kinabalu Park , Sepilok Aboretum , Tenom Orchid Center , example , includes in its scope any compound , chemical or and several Agriculture Research Centers . In Sarawak , the curative agent , molecule or product which has pharmaceu - Botanic Garden in Semonggok is the main center . With the tical , medicinal , biotechnological , scientific , commercial , exception of the aboreta in ï쳌¦ ï쳌² ï쳌© ï쳌­ , most of the other forest or economic value , properties , or potential . genetic collections are small in size . Two contentious issues invariably appear when we deal with the scope of the application of the draft law on access Commercial VersusAcademicAccess . Malaysia is of the to genetic resources . The first is the issue of ex situ collec - opinion that if there were no discrimination or distinction tions obtained pre - ï쳌£ ï쳌¢ ï쳌¤ , i.e . , all exotic genetic materials ( for between academic research and commercial exploitation , example , rubber , oil palm , and cocoa ) obtained through research would be stifled , since researchers would be re - various collection missions and exchange programs before quired to undergo the same stringent process as commer - ï?? ï?? December ï?? ï?? ï?? ï?? . Malaysia is of the opinion that such 8 cial bioprospectors . From current experience faced by materials should not be covered in the scope and thus be researchers in two States , namely , Sabah and Sarawak , subjected to benefit sharing . Any reference to pre - ï쳌£ ï쳌¢ ï쳌¤ where the State law does not differentiate between the two years should be outside the scope and context of the ï쳌£ ï쳌¢ ï쳌¤ categories of applicants , nondiscrimination has proven to as well . The second is the issue of benefits arising from be a hindrance to research activities . We are in favor of the the use of biological resources including derivatives and 9 principle based on the â?? Free For All Malaysians â?쳌 feature products . Malaysia is of the opinion that such benefits ( i.e . , free access to our own biological resources ) . should be included in the scope of the draft law , since The restriction on access to genetic resources should be derivatives and products of the biological resources will discriminatory so as to facilitate enforcement . Therefore , offer value - added options for benefit sharing . However , 10 this issue continues to remain unclear and contentious it is proposed that reference to and approval of the ï?? ï?? ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? ï?? : M ï쳌¡ ï쳌¬ ï쳌¡ ï쳌¹ ï쳌³ ï쳌© ï쳌³ ï쳌¡ 11 competent authority is required in three circumstances , pector name a local collaborator ( a Malaysian institution ) namely : that will collaborate in collection , research , development , and other activities in relation to the biological / genetic re - â?¢ When there is commercial exploitation ; source concerned.A foreign bioprospector is also required â?¢ When R & D is done in collaboration with foreign - to name the foreign institution that will act as a sponsor ers ; and organization and will be responsible for the actions of the â?¢ When the biological resources are to leave the collector ( to whom the access license has been granted ) . country . Both national and international bioprospectors are required to sign an access agreement with the competent author - Access Procedure ity and the relevant resource provider . However , where All scientists , whether they are foreigners or Malaysians , appropriate , the competent authority may decide that the would have to follow this access procedure in order to ob - restrictions relating to access to resources shall not apply tain access to genetic resources for commercial purposes . to Malaysian researchers conducting noncommercial and But international bioprospectors will have additional basic research . conditions for approval of the application . For example , The procedure for foreign scientists who want to obtain the access application will require that a foreign biopros - access for noncommercial purposes is still not clear at this Box 3 . Important Malaysian ex situ genetic resource collections Cocoa seedlings of endangered species and reintroducing them into For cocoa , prior to the setting up of the Malaysian Cocoa wild habitats . For example , Paphiopedilum rothschildianum Board ( ï쳌­ ï쳌£ ï쳌¢ ) in ï?? ï?? ï?? ï?? , various government agencies and plan - was reintroduced in the Kinabalu Park in ï?? ï?? ï?? ï?? . tations were involved in maintaining cocoa genetic materials . Rice At present , there are over ï?? ï?? ï?? clones held in various organiza - At the national level , the total rice germplasm collection tions in Malaysia . Since ï?? ï?? ï?? ï?? , ï쳌­ ï쳌£ ï쳌¢ has undertaken efforts to stands at more than ï?? ï?? , ï?? ï?? ï?? accessions including several collect and to establish all available cocoa genetic materials , local wild rice species ( A ï쳌¢ ï쳌¤ ï쳌µ ï쳌¬ ï쳌¬ ï쳌¡ ï쳌¨ et al . ï?? ï?? ï?? ï?? ) . All these including imported and locally selected clones , in its regional rice accessions are conserved ex situ in ï쳌­ ï쳌¡ ï쳌² ï쳌¤ ï쳌© â?? s Genebank research stations . With regard to fruits , various research bod - at the Rice Research Center in Seberang Perai . About one ies in the country have collected and maintained indigenous half of this collection comprises indigenous varieties which living collections of fruit genetic resources . Overall , the ex had been collected from remote areas nationwide . Some rice situ collections total more than ï?? ï?? ï?? species with over ï?? , ï?? ï?? ï?? germplasm was also collected and conserved in Sarawak at accessions ( M ï쳌¯ ï쳌¨ ï쳌¡ ï쳌­ ï쳌¡ ï쳌¤ et al . ï?? ï?? ï?? ï?? ) . The various institutions the Agricultural Research Center in Semonggok , which that provide for in situ conservation of fruits include ï쳌¦ ï쳌² ï쳌© ï쳌­ maintains ï?? , ï?? ï?? ï?? rice accessions . The ï쳌³ ï쳌¤ ï쳌¯ ï쳌¡ maintains over in Kepong , Forest Research Center in Sepilok , Sabah and ï?? , ï?? ï?? ï?? collections of three rice species . Sabahâ??s Department of Agriculture ( ï쳌³ ï쳌¤ ï쳌¯ ï쳌¡ ) . Rubber Oil palm Rubber also has a narrow genetic base , as most of the present The genetic base upon which oil palm breeding populations plantings are derived from a small collection of ï?? ï?? seedlings had been established in Malaysia is extremely narrow , as it originated from the four seedlings planted in the Botanic brought from Brazil around ï?? ï?? ï?? ï?? . This situation is further Garden in Bogor in ï?? ï?? ï?? ï?? . Efforts to broaden the genetic exacerbated by the planting of a few selected , high yielding base received a boost in ï?? ï?? ï?? ï?? when ï쳌­ ï쳌¡ ï쳌² ï쳌¤ ï쳌© and the Nigerian clones . To prevent the possibility of a genetic calamity in the Institute for Agriculture Research collaborated in large - scale near future , the Rubber Research Institute of Malaysia ( now prospecting in Nigeria , followed by many subsequent col - known as the Malaysia Rubber Board ) embarked on an on - go - lecting and prospecting missions . The present field genebank ing enhancement program by introducing materials from the collection in the Malaysian Palm Oil Board Research Center centers of diversity . These comprised the ï?? ï?? ï?? ï?? â?? ï?? ï?? ï?? ï?? importa - in Kluang totals more than ï?? , ï?? ï?? ï?? accessions of the oil palm tion , the ï?? ï?? ï?? ï?? importation , and the ï?? ï?? ï?? ï?? prospecting mission . species Elaeis guineensis and E . oleifera from various parts The ï?? ï?? ï?? ï?? prospecting mission carried out by the International of Africa and tropical Central and South America . Rubber Research and Development Board ( ï쳌© ï쳌² ï쳌² ï쳌¤ ï쳌¢ ) resulted in a collection totaling ï?? ï?? , ï?? ï?? ï?? seeds and ï?? , ï?? ï?? ï?? m budwood Orchid 15 from ï?? ï?? ï?? presumably high yielding ortet trees . In compli - The ex situ orchid species collection is maintained in ï쳌­ ï쳌¡ ï쳌² ï쳌¤ ï쳌© , ance with the International Code of Plant Collection , ï?? ï?? % Serdang . The collection of indigenous species began in ï?? ï?? ï?? ï?? , were retained in Brazil while the balance was distributed to and there are still active collection trips , especially to unex - Malaysia ( ï?? ï?? % ) and Ivory Coast ( ï?? ï?? % ) for conservation , ploited areas such as the Belum Forest.A small orchid species evaluation , utilization , and redistribution to other ï쳌© ï쳌² ï쳌² ï쳌¤ ï쳌¢ collection is also maintained in ï쳌­ ï쳌¡ ï쳌² ï쳌¤ ï쳌© , Cameron Highlands . countries . In ï?? ï?? ï?? ï?? , Malaysia carried out another major pros - More than ï?? ï?? ï?? species of lowland wild orchids are also being pecting mission in Brazil and successfully collected ï?? ï?? , ï?? ï?? ï?? maintained by ï쳌³ ï쳌¤ ï쳌¯ ï쳌¡ in the Tenom Orchid Center . Apart from seeds from eight Hevea species , of which only ï?? ï?? , ï?? ï?? ï?? seeds collecting , the Center is also helping in conservation activities of orchid species through collection and culture of seeds or germinated and ï?? ï?? , ï?? ï?? ï?? plants were established . ï?? ï?? ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ point . The economic costs of applying for access are not with regard to access activity ) ; expected to be prohibitive to the bioprospectors . However , â?¢ Details of collectorâ??s proposed access activity , such costs have not yet been ascertained . The country is namely : fully aware of the fact that some neighboring countries in â?? Types of material to be collected or knowledge the region have similar biodiversity , and this fact is taken or innovation to be accessed ; into consideration on such matters . Again , comparative â?? Sites of access activity or where the resource is analysis on such costs has not been done . The proposed located ; access procedure is envisaged to comprise the following â?? Quantity and intended use of the resource , steps ( Figure ï?? ) . including intention to commercialize ; â?? Time when the access activity is to be carried Application 12 out ; and Applications for an access license shall be submitted 13 â?? Environmental and socioeconomic impact as - to the competent authority in writing , together with a sessment . prescribed application fee . There shall be no access to biological resources or community knowledge and innova - â?¢ ï쳌° ï쳌© ï쳌£ by the resource provider ; tion without an access license granted by the competent â?¢ Benefit - sharing arrangements ( what benefits shall 14 authority . Upon conviction , any collector found guilty of be derived : payments , royalties , beneficiaries , etc . ) ; an offense shall be liable for a prescribed fine . and 16 Information required in the application includes : â?¢ The identity of the local collaborator or sponsor ( a Malaysian institution ) . â?¢ The collectorâ??s identity ( including the identity of a foreign institution or organization that will act as a Upon receiving the application , the competent au - sponsor , responsible for the actions of the collector thority may make the information therein available to the Application for License Public consultation , Evaluation Further information , when required Decisiong makin Review Appeal process process Access agreement Yes No approved or rejected Endorsement by authority of Government of Collectorâ??s country , if necessary Access agreement Figure ï?? . Proposed access procedure ï?? ï?? ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? ï?? : M ï쳌¡ ï쳌¬ ï쳌¡ ï쳌¹ ï쳌³ ï쳌© ï쳌³ ï쳌¡ public , and if necessary , provide for public consultation . Monitoring and Enforcement Where the resource provider ( s ) is the indigenous and local Existing monitoring and enforcement authorities shall be community , the competent authority shall ensure that the responsible for monitoring and enforcement of this law , concerned indigenous and local community who may be within their respective sectors or jurisdictions , and include affected by the application are informed and consulted , the following : and their ï쳌° ï쳌© ï쳌£ is obtained . â?¢ Monitoring of collection or access activity , report - ing requirements , and procedures ; and Evaluation of Application Factors which the competent authority shall take into ac - â?¢ Powers of arrests , entry , search and seizure with count in evaluating an application include : respect to offenses under the law . â?¢ The activity should contribute to , and not under - Institutional Structure mine , the conservation and sustainable use of 17 Two options have been proposed with regard to the in - biological resources . stitutional structure under which the draft Bill might be â?¢ Impact assessments on biological resources , the implemented ( Table ï?? ) . Option ï?? . The federal government environment , and ecology are provided . is to designate a Federal authority as the competent author - â?¢ Impact assessments on communities and their ity . This means that the Federal authority shall receive , knowledge , innovations , and practices ( Article ï?? ( j ) process , and grant all applications for a ) access to biologi - of ï쳌£ ï쳌¢ ï쳌¤ ) are provided . cal resources and b ) access to community knowledge and â?¢ ï쳌° ï쳌© ï쳌£ has been obtained in writing from the resource innovations . There will be a national body ( the National owner in accordance with the prescribed procedure . Biodiversity Council , modeled on the Environmental Quality Council ) to be set up to formulate policy and â?¢ The benefit - sharing arrangement is fair and equi - make recommendations to the competent authority on table . implementation of the law . When determining what is fair and equitable benefit Option ï?? : State governments are to designate State sharing , the competent authority may take into account competent authority to receive , process , and grant access the factors such as : endemism or rarity of the biological applications for access to lands within the State territories . resource ; the conservation status of the biological re - The federal government is to designate Federal competent source ; its existing , potential , intrinsic , and commercial authority to receive , process , and grant access applications value ; its intended use ; and whether traditional knowledge for : a ) access to lands within Federal territories , and b ) ac - is involved . cess to community knowledge and innovations . There will Decision - Making Procedure be national body ( e.g . the National Biodiversity Council In making a decision on the application , the competent which is modeled on the National Land Council ) to be set authority may , if necessary , request further information up to advise the State and Federal competent authorities with regard to the application , and shall notify the collec - on implementation of the law . There will also be a Federal tor in writing of its decision . The decision made by the body ( new or designated ) which will be the national co - competent authority can be either approved with or without ordinating and clearinghouse mechanism , and which will conditions or rejected . A decision can be appealed and the receive and channel to appropriate competent authorities appeal process begun at any time within three months of all applications for access licenses . the date of receipt of the decision . The relevant sectoral authorities will administer and implement the proposed law or policy . These include Conditions for Approval the national and State Departments of Agriculture , the Approval of an application may be contingent on an agree - national Veterinary Services Department , the national ment in writing ( an access agreement ) , an indemnity or Fisheries Department , the national Department of Wildlife guarantee , on obligations during collection or access ac - and National Parks , the State forest departments , and the tivity ( quantities or species of material to be collected ) , various State ministries in Sarawak and Sabah . obligations after collection or access activity ( deposit of Therefore , responsibility to enforce the law or policy specimens , records , report of activities ) , and other condi - rests with both national and State administrations . A coor - tions . dinating body or national focal point is needed . No body Review of Decision exists presently to ensure consistency in decision making , Any approval given may be revoked or subject to further to monitor implementation , to assess progress , and to act as conditions upon review of such approval . Grounds for a national focal point while providing recommendations on such review include when new information or review of how the law or policy could be improved in the future . existing information establishes risks or adverse impacts Novel Provisions of the Future Law or Policy on the environment , biological resources , or communi - There is a provision which allows exemptions or nonap - ties or when serious impacts or unanticipated effects on plicability of the law if access to genetic resources is biological resources , environment , communities , and ecology occur . undertaken by any of the following : ï?? ï?? ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ propagating materials , that are grown on their â?¢ The general public for their own utilization ; own land . â?¢ Public officers in the course of carrying out their public duties ; Another provision proposes the establishment of a â?¢ Malaysian researchers affiliated with local in - common trust fund where knowledge and innovation can - stitutions conducting noncommercial bona fide not be attributed to a particular community.Any access ac - research ; tivity seeking to use traditional knowledge for commercial utilization shall pay to the fund a sum , to be determined , â?¢ Indigenous and local communities , to continue with representing a percentage of the gross sales of any prod - their traditional and customary practices relating uct or process utilizing or incorporating the traditional to the keeping , use , exchange , sharing , marketing , knowledge . The competent authority and the indigenous or sale of biological resources by and among such or local community shall then be jointly responsible for the communities ; and equitable distribution of the monies solely for the benefit â?¢ Farmers to replant on their own land , exchange , of the concerned indigenous or local community . The pay - or sell for further propagation , seeds and other ment made to the said fund will be administered by the competent authority for use in promoting the welfare of the Table ï?? . Examples of the relevant sectoral authori - indigenous and local communities and for the conservation ties that will administer and implement the Access to and sustainable use of the biological resources . Genetic Resources Bill Provisions not Included in the Bill Federal Ministry of Agriculture The following three items were discussed earlier , but are ï?? . Department of Agriculture still considered contentious , both at national and interna - Enforcement of Pesticides Act of ï?? ï?? ï?? ï?? and Plant tional levels and thus were not included in the Bill . Quarantine Act of ï?? ï?? ï?? ï?? . ï?? . Department of Fisheries ( ï쳌¤ ï쳌¯ ï쳌¦ ) â?¢ When a patent has been granted over a product or Administration and enforcement of Fisheries Act of ï?? ï?? ï?? ï?? process as a result of access activities in Malaysia , and Exclusive Economic Zone Act of ï?? ï?? ï?? ï?? for the proper the establishment of a provision to regulate the in - management and conservation of inshore and deep sea re - ventions , including granting compulsory licenses sources . The ï쳌¤ ï쳌¯ ï쳌¦ also develops , administers and manages on the grounds of public interest or necessity to the waters of the ï?? ï?? designated Marine Parks in Malaysia . compensate for the high costs or insufficient supply ï?? . Veterinary Services Department of the said product or process ; The Animal Quarantine Station manages the import and export of wildlife . â?¢ The establishment of a proposed system of inter - Federal Ministry of Primary Industries national cooperation with the relevant authorities ï?? . Federal Forest Department of other countries to incorporate a provision that Responsible for administration and management of all for - patents should not be granted without the prior con - est resources and is guided by the National Forest Policy . sent of the country of origin , to prevent biopiracy States are empowered to formulate independent forest or the misappropriation of traditional / traditional policies , and the Department provides advice and technical knowledge through patenting abroad of a product , assistance to them . process , or knowledge by persons or institutions of Federal Ministry of Science , Technology and the other countries ; and Environment ï?? . Department of Environment â?¢ The establishment of a system of community in - Administers and enforces the Environmental Quality Act tellectual rights for the purpose of the recognition of ï?? ï?? ï?? ï?? . It also assesses development projects subject to of ownership rights of communities over their the environmental impact assessment order with respect to knowledge and innovations , the protection of the their impact on the environment . communities â?? knowledge and innovations , and for ï?? . Department of Wildlife and National Parks ensuring that an equitable share of benefits arising Manages wildlife reserves and national parks , and ad - from use of such knowledge is channeled back to ministers and enforces the Convention on International the communities , including setting up a system of Trade in Endangered Species of Wild Fauna and Flora , and Wildlife Enactment of ï?? ï?? ï?? ï?? . collection and registration of traditional knowledge and innovations , establishing technical institutions , State Ministry of Sarawak ï?? . Sarawak Biodiversity Center and registering indigenous and local community Ensures conservation of Stateâ??s biodiversity , identifies new organizations . natural and biotechnological products ( bioprospecting ) that can bring socio - economic benefits , and facilitates and authorizes access to Sarawakâ??s biological resources . State Ministry of Sabah ï?? . Sabah Biodiversity Center Ensures conservation of the Stateâ??s biodiversity , and facili - tates and authorizes access to Sabahâ??s biological resources . ï?? ï?? ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? ï?? : M ï쳌¡ ï쳌¬ ï쳌¡ ï쳌¹ ï쳌³ ï쳌© ï쳌³ ï쳌¡ Bioprospecting Projects Bioprospecting is defined as the search for new bioac - During the past few years , several foreign and multina - tive compounds from biological resources as diversified tional companies were interested in applying for access to as plants , soil microbes , marine sponges , and insects . In biological resources , despite the fact that the Government general , bioprospecting involves the collection ( access ) was in the midst of working on the law or policy to be of a diverse range of biological resources or organisms , adopted . For example , a Japanese company wanted access the preparation of crude abstracts for multiple biologi - to soil samples for microbes and a multinational company cal screening , and the isolation of chemicals , enzymes , wanted access to forest species for pharmaceuticals . In secondary metabolites , genetic materials , and others that fact , a model agreement intended to ensure minimum may provide leads for the development of new commer - standards and to facilitate benefit - sharing arrangements cial products in the pharmaceutical , food , and agricultural in biodiversity prospecting activities was developed in industries . In bioprospecting , ethnobotanical information response to access interest from a foreign company . This can serve as an important lead in drug discovery and model agreement became the basis of the draft â?? Access other specific uses . Biotechnology is also increasingly Agreement for Research , Collection and Utilization of being used to capitalize on various biological and genetic Biological / Genetic Resources for Environmentally Sound resources . Uses â?쳌 . Many prospective bioprospectors have some idea Currently , there are only a mere handful of bioprospect - about what is in the offing for the proposed national leg - ing projects that are going on in the country , virtually all islation , and many are becoming fully aware of the State of which are of a noncommercial nature . An exception is laws of Sarawak and Sabah . Most bioprospectors hope that the involvement of the Government of Sarawak in a joint Malaysia does not enact very restrictive national access venture in bioprospecting collaboration , which will be legislation and regulations . described in more detail later . One of the most active as - In any case , it should be noted that , at present , no pects of these projects is the search for potentially valuable Malaysian personnel are specialists in the negotiation of medicinal products or for potentially useful compounds for bioprospecting agreements . Negotiation is very critical , modern drug development from tropical plants carried out since during negotiation with a technology partner , rights by research institutions and universities ( Table ï?? ) . Many and commercialization benefits are ascertained at the researchers , however , still consider such projects to be at beginning of the relationship . The amount of rights and the infancy stage , as well as expensive , technologically dif - benefits available to the biological resource owner is quite ficult , and better left to be carried out by affluent developed dependent on negotiating skills as well as on the investment countries or multinational companies ( A ï쳌º ï쳌© ï쳌º ï쳌¯ ï쳌¬ and L ï쳌¥ ï쳌¡ ï쳌® contributed . There is a need for capacity building for such ï?? ï?? ï?? ï?? ) . More recently , a few medicinal plants have been personnel in the near future to assist government agencies , accorded research priorities by the National Biotechnology research institutions , and others who are involved in bio - Directorate , for example , tongkat Ali ( Eurycoma longi - diversity prospecting arrangements . It is particularly im - folia , Simarubaceae ) , hempedu bumi ( Andrographis pa - portant to be aware of the required â?? minimum â?쳌 standards niculata , Acanthaceae ) , kacip fatimah ( Labisia pumila , or terms where there is no existing legislation or policy Myrsinaceae ) , and pegaga ( Centella asiatica , Apiaceae ) . on such matters . It should also be noted that bioprospect - The first three have even been aggressively promoted in ing arrangements are going to reflect commercial realities commercial products . and common best practices , and we need personnel with Pharmaceutical products are also being developed from the ability to negotiate mutually agreeable and satisfy - various marine organisms . Sponges , corals , tunicates , and ing terms . In order to prepare for increasing numbers of algae are among the organisms which produce compounds agreements to be negotiated by government agencies in the that have been shown to have antibiotic , antitumor , anti - future , more attention should be devoted to developing the viral , or anti - inflammatory activities . For example , ï쳌µ ï쳌« ï쳌­ business and negotiating skills of those involved in pros - tested ï?? ï?? samples of marine sponges on human tumor pecting agreements , since the quality of the agreements cell lines in cytotoxic tests and found ï?? ï?? samples to be is essential in ensuring a practical contribution to an ac - toxic to the tumors , while sea cucumbers were screened cess regime . As previously mentioned , several companies at Universiti Sains Malaysia for bioactive compounds were interested in bioprospecting attempts but these did ( O ï쳌´ ï쳌¨ ï쳌­ ï쳌¡ ï쳌® and L ï쳌¯ ï쳌¦ ï쳌´ ï쳌© ï?? ï?? ï?? ï?? ) . not materialize into agreements for many reasons . One More recently , preliminary screening for novel drugs such reason could be due to the lack of negotiating skills , has also been carried out on bacteria , myxobacteria , and both at the Federal and State levels . fungi collected from rich lowland dipterocarp rainforests and mangrove forests . Excellent targets for such screens An Example of Commercial Bioprospecting are components of the signal transduction pathway and and International Collaboration in Sarawak cell cycle in the pursuit of effective treatment and the un - In ï?? ï?? ï?? ï?? , the ï쳌µ ï쳌³ ï쳌¡ National Institutes of Health , through the derstanding of diseases such as cancer and Alzheimerâ??s disease ( H ï쳌¯ et al . ï?? ï?? ï?? ï?? ) . Natural Products Branch of the National Cancer Institute ï?? ï?? ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ Table ï?? . Examples of research on medicinal plants in Malaysia ( adapted from M ï쳌¯ ï쳌¨ ï쳌¡ ï쳌­ ï쳌¡ ï쳌¤ et al . ï?? ï?? ï?? ï?? ) Common name Species / Genus / Family Use / Potential use / Study Forest Research Institute Malaysia a â?? Leuconotis spp . Medicinal properties Mambu Azadirachta indica " Pokok minyak kayu putih Melaleuca cajuputi " Kandis Dipterocarpus spp . " Cempaka hutan Aromadendron spp . " Edible medicinal plants ( ulam ) : Antioxidant activity ( V ï쳌© ï쳌­ ï쳌¡ ï쳌¬ ï쳌¡ et al . ï?? ï?? ï?? ï?? ) Selom , Pegaga , Oenanthe javanica , Centella asiatica , Terung kecil , Kesom , Solanum ferox , Polygonum minus , Kadok , Ulam raja , Piper sarmentosum , Cosmos caudatus , Cemumar , Beluntas Micromelum pubescens , Pluchea indica Universiti Kebangsaan Malaysia Lada hitam Piper nigrum Phytochemical and pharmacological studies Pinang Areca catechu â?? Pokok minyak kayu putih Melaleuca cajuputi Survey of essential oils Putarwali Tinospora crispa Studies on tissue culture techniques â?? Alstonia angustifolia , Crotalaria spp . , Cytotoxic effects ( I ï쳌« ï쳌² ï쳌¡ ï쳌­ et al . ï?? ï?? ï?? ï?? ) Mitragyna speciosa â?? Goniothalamus spp . Antiproliferative effect ( Z ï쳌¡ ï쳌µ ï쳌¹ ï쳌¡ ï쳌¨ et al . ï?? ï?? ï?? ï?? ) Betik ( flower ) , Putat , Carica papaya , Barringtonia macrostachya , Antitumor promoting activity ( L ï쳌© ï쳌­ et al . ï?? ï?? ï?? ï?? ) Ubi keling / Kemili , Coleus tuberosus , Pelam epal ( skin ) , Mangifera indica , Serai kayu Eugenia polyantha Universiti Malaya Mempisang Annonaceae Widely used as medicines by local natives Gambir Uncaria spp . Antihypertensive properties Bintangor Calophyllum spp . Diverse bio - activities â?? Trema orientalis Analgesic and anesthetic effects ( H ï쳌¡ ï쳌³ ï쳌¨ ï쳌© ï쳌­ et al . ï?? ï?? ï?? ï?? ) Universiti Malaysia Sarawak Oran , Pelai , Ageratum conyzoides , Alstonia scholaris , Antibacterial properties Pedada , Rugin , Brucea javanica , Cassia alata , ( F ï쳌¡ ï쳌³ ï쳌© ï쳌¨ ï쳌µ ï쳌¤ ï쳌¤ ï쳌© ï쳌® and G ï쳌¨ ï쳌¡ ï쳌º ï쳌¡ ï쳌¬ ï쳌¬ ï쳌¹ ï?? ï?? ï?? ï?? ) Sengkayap , Engkara - bai , Eurycoma longifolia , Pasychotria viridiflora , Kelapahit , Akar kelait Quassia indica , Unicaria longiflora Universiti Putra Malaysia Zingiber Zingiberaceae Studies on medicinal properties Jarum emas Striga asiatica " Gelenggang Cassia alata " Kenarah Goniothalamus spp . " Bratawali / Putarwali Tinospora crispa " Universiti Sains Malaysia Pokok kapal terbang Eupatorium odoratum As an analgesic Gajah beranak Goniothalamus macrophyllus As an abortifacient and antifertility agent or Selayak hitam Tongkat Ali Eurycoma longifolia For antimalaria action Api - api Avicennia spp . Pharmacological studies â?? , Selayak hitam , Cerbera odollam , Goniothalamus Toxicity screening ( S ï쳌¡ ï쳌­ et al . ï?? ï?? ï?? ï?? ) Pokok German macrophyllus , Eupatorium odoratum â?? Malpighiaceae coccigera Antilithotrophic , antiasthmatic and as relief for yellow fever ( U ï쳌¢ ï쳌¡ ï쳌© ï쳌¤ ï쳌© ï쳌¬ ï쳌¬ ï쳌¡ ï쳌¨ et al . ï?? ï?? ï?? ï?? ) Universiti Teknologi Malaysia Kunyit Curcuma spp . Studies on medicinal roots Medang Alseodaphne perakensis Studies on chemical structures and activities Petai Parkia speciosa Study on hypoglycemic activity ªThe symbol â?? â?? â?? indicates that no common name was available for the species . ï?? ï?? ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? ï?? : M ï쳌¡ ï쳌¬ ï쳌¡ ï쳌¹ ï쳌³ ï쳌© ï쳌³ ï쳌¡ ( ï쳌® ï쳌£ ï쳌© ) , commenced a program to acquire plant extracts the Sarawak Government . derived from different parts of the world and to screen Negotiations began in ï?? ï?? ï?? ï?? between the State such extracts for anticancer and anti - ï쳌¨ ï쳌© ï쳌¶ activities . One Government of Sarawak and MediChem Research , cul - of the source countries selected by the ï쳌® ï쳌£ ï쳌© was Malaysia , minating in a Joint Venture Agreement between the two and subsequently a collection mission was conducted in parties in ï?? ï?? ï?? ï?? . This fulfilled the ï쳌® ï쳌£ ï쳌© â?? s obligations , as Sarawak in ï?? ï?? ï?? ï?? ( J ï쳌¥ ï쳌® ï쳌´ ï쳌¡ et al . ï?? ï?? ï?? ï?? ) . This led to the isola - specified in their â?? Letter of Collection â?쳌 with the Sarawak tion of calanolide A from cuttings of the plant bintangor Forestry Department in ï?? ï?? ï?? ï?? . In ï?? ï?? ï?? ï?? , the joint venture ( Calophyllum lanigerum , Guttifereae ) , and the discovery company , owned equally by the two partners and for - in ï?? ï?? ï?? ï?? that this naturally occurring compound was active mally known as Sarawak MediChem Pharmaceuticals , against ï쳌¨ ï쳌© ï쳌¶ . Shortly thereafter , in ï?? ï?? ï?? ï?? , calanolide B was Inc . , commenced operation with the primary function to discovered from samples of C . teysmannii through a re - col - advance the development of calanolide A as an anti - ï쳌¨ ï쳌© ï쳌¶ lection mission . The original purpose of the re - collection agent . Secondly , Sarawak MediChemâ??s function was to mission was to obtain more quantities of calanolide A , spearhead the development of other promising calanolide - since only small quantities of the compound were isolated based therapeutics . In ï?? ï?? ï?? ï?? , MediChemâ??s original share in the first collection mission . Calanolide B was also found in the company was wholly transferred to Advanced to be active against ï쳌¨ ï쳌© ï쳌¶ , but unlike calanolide A , it was Life Sciences , Inc . Through co - ownership , the Sarawak present in greater abundance from its natural source . Government and ï쳌® ï쳌£ ï쳌© will receive royalties on any future Following the ï쳌® ï쳌£ ï쳌© â?? s confirmation of the therapeutic sales of a calanolide drug , apart from the benefit from the properties of the calanolides , efforts were directed towards transfer of technology and training . There continues to obtaining sufficient quantities of the compounds for pre - be direct involvement of scientists from Sarawak in the clinical evaluation . In ï?? ï?? ï?? ï?? , ï쳌® ï쳌£ ï쳌© awarded MediChem management of the company and in the companyâ??s pre - Research an R & D grant to develop a synthetic route clinical and clinical drug development programs . Under to calanolide A . MediChem scientists were successful Sarawakâ??s ï?? ï?? ï?? ï?? Biodiversity Center Ordinance and ï?? ï?? ï?? ï?? and their efforts were duly recognized by ï쳌® ï쳌£ ï쳌© in ï?? ï?? ï?? ï?? . Access , Collection & Research Regulations , there is a Subsequently , ï쳌® ï쳌£ ï쳌© awarded MediChem an exclusive framework for discovery and partnering in future drug license to their patents , which included the preparation development initiatives based on materials derived from and use of the calanolides . Under the terms of the license , MediChem was obliged to negotiate an agreement with the rainforests of Sarawak . Intellectual Property Rights and the Agreement on Trade - Related Aspects of Intellectual Property Rights ( TRIPS ) By virtue of the ï쳌£ ï쳌¢ ï쳌¤ , we have sovereign rights over our be recognized with respect to a ) plants , animals , and natu - natural resources but not automatic rights over products or rally occurring microorganisms , including parts thereof derivatives developed from these resources . These rights and b ) essentially biological processes and naturally occur - belong to the party who owns the intellectual property ring microbiological processes . No application for patents rights ( ï쳌© ï쳌° ï쳌² s ) to the products or derivatives . And more often with respect to inventions involving biological resources than not , such a party is the one with the technology to shall be granted without the prior approval of the com - derive commercial value from the biological resources . In petent authority so as to ensure that the patent protection this regard , it is the owner of the biological resources who thereof shall be supportive of , and not run counter to , the is responsible for coming up with an intellectual property objectives of the Bill . framework ( laws and procedures ) under the ï쳌£ ï쳌¢ ï쳌¤ . The provisions on patentability have to be read in con - Intellectual property includes patents , copyrights , junction with the provisions of the Malaysian Patent Act 18 trademarks and designs . ï쳌© ï쳌° ï쳌² s , especially patents , are said of ï?? ï?? ï?? ï?? ( Act ï?? ï?? ï?? ) on the requirements of patentability . to help those in control of the resources to obtain economic It is noted that amendments to the Patents Law are being benefits from them , and this in turn would be an incentive considered , in order to comply with ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ , specifically to conserve rather than destroy the forest . According to with regard to the patenting of life requirements of Article section ï?? ï?? of the Patents Act of ï?? ï?? ï?? ï?? , patents are granted ï?? ï?? . ï?? ( b ) of ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ . To satisfy the requirements of ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ , a to a novel invention which is commercialized . An inven - draft Protection of New PlantVarieties Bill was developed . tive step must also be involved in developing the product . It is essentially a sui generis system for the protection of Plants , animals and biological processes to obtain new plant genetic resources . The Bill was supposed to be have varieties or strains are not patentable by virtue of section been tabled in the Parliament as early as ï?? ï?? ï?? ï?? , but only ï?? ï?? ( ï?? ) of the Act unless , they are human - made living mi - became law in ï?? ï?? ï?? ï?? ( Protection of New Plant Varieties croorganisms or microbiological processes . Act ï?? ï?? ï?? ï?? , Act ï?? ï?? ï?? , Laws of Malaysia ) . The Access to Genetic Resources Bill includes a â?? non - There are no other intellectual property right instru - patentability â?쳌 provision which means that no patents shall ments that protect inventions derived from genetic re - ï?? ï?? ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ sources and traditional knowledge . However , it has been the ï쳌£ ï쳌¢ ï쳌¤ â?? s objectives . This can be done by harmonizing the different approaches of the ï쳌£ ï쳌¢ ï쳌¤ and ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ , as the former determined that the provisions of the Patents Act of ï?? ï?? ï?? ï?? recognizes the sovereign rights of States over their genetic are â?? insufficient â?쳌 to protect Malaysiaâ??s interest under resources , and the latter treats intellectual property as a Article ï?? ï?? of the ï쳌£ ï쳌¢ ï쳌¤ . The scope of what can be patent - private right . able is not very clear as to whether genes are patentable . The objectives of the ï쳌£ ï쳌¢ ï쳌¤ , particularly for ensuring Moreover , there is no specific provision in this Act that the fair and equitable sharing of benefits arising out of could relate to the protection of traditional knowledge 19 the utilization of genetic resources , could be achieved if related to genetic resources . Given the development the application procedures for the ï쳌© ï쳌° ï쳌² s require that the in the international arena especially relating to genetic applicant submit evidence of ï쳌° ï쳌© ï쳌£ . However , obtaining the resources , it is necessary to review the Patent Act of ï?? ï?? ï?? ï?? ï쳌° ï쳌© ï쳌£ of competent national authorities and holders of tra - to harmonize the provisions of this Act with Malaysiaâ??s ditional knowledge may prove to be difficult , especially if international obligations under the ï쳌£ ï쳌¢ ï쳌¤ and ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ and the material is obtained from a research institution lacking with the Protection of New Plant Varieties Act of ï?? ï?? ï?? ï?? knowledge of the origin of the material , or if it is a plant ( Malaysiaâ??s response to Article ï?? ï?? . ï?? ( b ) of ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ ) genetic resource for food and agriculture covered by a pos - sible multilateral system for access and benefit sharing on The Impact of IPRs on Biodiversity and certain plant genetic resources for food and agriculture . Traditional Knowledge The traditional forms of ï쳌© ï쳌° ï쳌² s are inadequate to protect It has been argued that ï쳌© ï쳌° ï쳌² s could encourage access and indigenous knowledge , because they are based on pro - benefit sharing , if applications for such rights require tection of individual intellectual property rights , whereas identification of the source of genetic material used in traditional knowledge is collective . Such knowledge , the development of subject matter protected by ï쳌© ï쳌° ï쳌² s and developed over a period of time and codified in texts or proof of ï쳌° ï쳌© ï쳌£ of the competent authority of the provider retained in oral traditions over generations , may not be able country , if the genetic resource was acquired after the entry to satisfy all the conditions required , such as the novelty into force of the ï쳌£ ï쳌¢ ï쳌¤ and does not fall within the scope of and innovative steps required for the granting of patent a possible multilateral system for plant genetic resources protection to traditional knowledge . For the protection of for food and agriculture . traditional knowledge , innovations , and practices in rela - Article ï?? ï?? ( ï?? ) of the ï쳌£ ï쳌¢ ï쳌¤ recognizes that patents and tion to the use of genetic resources , the following forms other ï쳌© ï쳌° ï쳌² s may have influence on its implementation . In this of mechanisms could be considered : documentation of regard , subject to national legislation and international law , traditional knowledge , a registration and innovations patent the contracting parties to the ï쳌£ ï쳌¢ ï쳌¤ shall cooperate to ensure system for traditional knowledge , a sui generis system for that such rights are supportive and do not run counter to protecting traditional knowledge . The FAO International Undertaking and the International Treaty on Genetic Resources for Food and Agriculture The International Undertaking has had a strong influence genetic resources , for an agreed list of crops ( ï쳌© ï쳌´ ï쳌° ï쳌§ ï쳌² ï쳌¦ ï쳌¡ Annex I ) established on the basis of interdependence and on the national policy and the proposed access bill , in par - food security . Malaysia is not a signatory of the treaty and , ticular with regard to ex situ collections procured pre - ï쳌£ ï쳌¢ ï쳌¤ . at this point in time , it is still too early to assess the impact However , issues surrounding the ex situ collections still of the treaty on the Access to Genetic Resources Bill and remain largely unresolved . Malaysia is really in a unique the State laws . However , Malaysia now has a strong inter - position , because the country is considered to be important est in and a commitment to become a member country in both as a donor as well as a recipient country . the very near future . The provisions of the treaty should After a long negotiation process , the International be taken into account in the draft access Bill , particularly Undertaking became the International Treaty on Plant with respect to existing ex situ collections ; for example , Genetic Resources for Food and Agriculture ( ï쳌© ï쳌´ ï쳌° ï쳌§ ï쳌² ï쳌¦ ï쳌¡ , rice is included in the Annex I of the treaty . adopted ï?? November ï?? ï?? ï?? ï?? ) . The treaty establishes a mul - tilateral system of access and benefit sharing for plant ï?? ï?? ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? ï?? : M ï쳌¡ ï쳌¬ ï쳌¡ ï쳌¹ ï쳌³ ï쳌© ï쳌³ ï쳌¡ Early Lessons and Recommendations that can be Identified from the Process Leading to the Development of the Draft Access Bill Early lessons learned include : basis for negotiations and also serve as a checklist of items for consideration . â?¢ Setting up an ad hoc committee / task force for national planning for access to genetic resources is imperative â?¢ The national consultative process should be initi - for developing a comprehensive legislation . ated as early as possible and be given adequate time â?¢ The involvement of ï쳌¡ ï쳌§ , ministries , and agencies for the benefit of all relevant stakeholders . with responsibilities for the management of bio - â?¢ Amending existing laws and enacting a compre - diversity in the country , and ï쳌® ï쳌§ ï쳌¯ s in the ad hoc hensive new law is usually a very complex and committee / task force is crucial to the process . long - term process , since we need to deal with wide - â?¢ The involvement of the indigenous and local com - ranging issues from the appropriate administrative munities at the early stage of the process would authority to enforcement to constitutional issues . be desirable in outlining an enforceable access â?¢ The important objectives of the National Policy on determination process , in particular with regard to Biological Diversity to optimize economic benefits ï쳌° ï쳌© ï쳌£ and equitable sharing of benefits . through the integrated conservation / sustainable â?¢ The involvement of the Stateâ??s representatives and use of biological diversity and to give priority the private sector and industries as early as possible to biodiversity prospecting activities need to be would also make the process more efficacious . promoted . â?¢ A national workshop on access to genetic resources â?¢ Political intervention may be necessary to speed was an effective means to assess the needs , oppor - up the process . tunities , resources and capacities in the country . â?¢ Pending the passing of the draft access Bill , ï쳌¥ ï쳌° ï쳌µ â?? s â?¢ The contributions from resource persons in the Guidelines on Research should continue to be national workshop , ( e.g . , from the ï쳌· ï쳌² ï쳌© , the ï쳌© ï쳌µ ï쳌£ ï쳌® adopted as a temporary measure of protection of genetic resources found in Malaysia . Environmental Law Center , and the Royal Botanic Gardens , Kew ) , were particularly useful in formu - Some specific recommendations with respect to the na - lating a national strategy for biodiversity prospect - tional implementation process include ( O ï쳌¨ ï?? ï?? ï?? ï?? ) : ing . â?¢ Increase awareness of the issues related to biodi - â?¢ For certain biological resources , experience and versity prospecting and access and benefit sharing expertise was lacking ; for example , microorgan - at the Federal and State levels . isms had never been legislated upon in any manner â?¢ Initiate a strategic planning process to define the in Malaysia . national strategic goals in terms of biodiversity prospecting , including a national consultation â?¢ Sustained awareness - raising endeavors involving process with key players and stakeholders . various stakeholders with regard to assessment / â?¢ Assess the role of legislation in the context of inventory of biological diversity and biodiversity strategic goals and examine the feasibility of a prospecting in the country could contribute effec - framework legislation to ensure a nationally con - tively to the process . sistent approach to the legal aspects of biodiversity â?¢ The enactment of their own state laws in Sarawak prospecting . and Sabah reflected the gravity of the Federal - State â?¢ Evaluate the legal protection of local and indig - jurisdictional dichotomy . enous knowledge and livelihoods and consider â?¢ The enactment of their own State laws in Sarawak the use of existing legal provisions to afford such and Sabah also highlighted the paramount impor - protection . tance of both their biological diversity and their â?¢ Build and develop the required institutional ca - indigenous and local communities . pacity to address biodiversity prospecting issues , â?¢ In formulating strict legal mechanisms for access to including further defining the role of the national genetic resources in Malaysia , we should consider focal point for biodiversity prospecting issues . the imposition of a ) a mandatory statutory require - â?¢ Evaluate existing rural development and other com - ment to obtain a license and b ) a separate access munity programs for replication as benefit - sharing agreement . mechanisms . â?¢ In order to promote bona fide local research and â?¢ Develop model agreements in consultation with development , there is a need for discrimination or relevant experts and build capacity in business and distinction between academic research and com - negotiating skills . mercial bioprospectors . â?¢ Consider appropriate funds or funding sources to â?¢ A model access agreement would provide a useful carry out the above recommendations . ï?? ï?? ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ Conclusions At present , there is no legislation specific to access to ge - as a comprehensive national legislation that will form part netic resources in Malaysia at the national level , but two of the national implementation process of the ï쳌£ ï쳌¢ ï쳌¤ . In line States ( Sabah and Sarawak ) have regulations that facili - with Malaysiaâ??s commitments , the National Policy on tate access to their genetic resources . However , Malaysia Biological Diversity is based on many salient principles , supports an effective regulatory framework for access to one of which is the recognition of the role of local com - genetic resources and the commercial utilization of such munities in the conservation , management , and utilization resources , so as to ensure that the economic benefits ac - of biological diversity , as well as their rightful share of the cruing therefrom are channeled towards conservation of benefits accruing therefrom . In addition , the action plan biodiversity and to the indigenous and local communities lists the undertaking of activities in biodiversity prospect - from whom knowledge of genetic resources are derived . It ing as a priority . would appear that opportunities exist for reaping benefits The eventual relationship between the federal ï쳌¥ ï쳌° ï쳌µ per - from the commercialization of biodiversity use . Based on mission and the new law is not clear . When the appropriate this premise , Malaysia is currently undertaking relevant competent authority ( s ) is set up under the new law to grant policy review to ensure that the proper measures are ad - an access license , it may be able to carry out the ï쳌¥ ï쳌° ï쳌µ â?? s opted to prevent negative impacts on biodiversity and to function . Thus the permission from ï쳌¥ ï쳌° ï쳌µ may no longer be ensure fair and equitable sharing of benefits , among other necessary.Applications for access licenses / permits may be goals . This pragmatic approach has been followed through made directly to the competent authority ( s ) ; however , such by the drafting of the Access to Genetic Resources Bill , required information may be kept , managed , and made an effort that was initiated as early as ï?? ï?? ï?? ï?? . available by the designated competent authority . The Access to Genetic Resources Bill is being drafted References A ï쳌¢ ï쳌¤ ï쳌µ ï쳌¬ ï쳌¬ ï쳌¡ ï쳌¨ M.Z . , D.A . V ï쳌¡ ï쳌µ ï쳌§ ï쳌¨ ï쳌¡ ï쳌® , and M ï쳌¯ ï쳌¨ ï쳌¡ ï쳌­ ï쳌¡ ï쳌¤ O . ï?? ï?? ï?? ï?? . I ï쳌« ï쳌² ï쳌¡ ï쳌­ , Z . Z ï쳌µ ï쳌² ï쳌© ï쳌¡ ï쳌´ ï쳌© , and H . H ï쳌¡ ï쳌² ï쳌µ ï쳌® ( eds . ) Bioassay guided th isolation of natural products . Proc . ï?? ï?? Annual Seminar Wild relatives of rice in Malaysia : Their characteristics , and ï쳌µ ï쳌® ï쳌¥ ï쳌³ ï쳌£ ï쳌¯ Regional Workshop on Bioassay Guided distribution , ecology and potential in rice breeding . ï쳌­ ï쳌¡ ï쳌² ï쳌¤ ï쳌© Isolation of Natural Products , Bangi , Malaysia . Report No . ï?? ï?? ï?? . Available from Malaysian Agricultural Research and Development Institute ( ï쳌­ ï쳌¡ ï쳌² ï쳌¤ ï쳌© ) , Serdang , J ï쳌¥ ï쳌® ï쳌´ ï쳌¡ T.R . , Z.Q . X ï쳌µ , and M.T . F ï쳌¬ ï쳌¡ ï쳌¶ ï쳌© ï쳌® . ï?? ï?? ï?? ï?? . Bioprospecting Malaysia . and international collaborations â?? the case of the calanolides . p . ï?? ï?? â?? ï?? ï?? in T.K . C ï쳌¨ ï쳌µ ï쳌¡ and E.Y.E . L ï쳌¥ ï쳌¥ A ï쳌º ï쳌© ï쳌º ï쳌¯ ï쳌¬ A.K . and T.N . L ï쳌¥ ï쳌¡ ï쳌® . ï?? ï?? ï?? ï?? . Bioprospecting in ( eds . ) Biodiversity ï?? ï?? ï?? ï?? Kuching . Proc . International Malaysia : ï쳌¦ ï쳌² ï쳌© ï쳌­ â?? s perspectives . Paper presented at Conference on Prudent Biodiversity Management and National Workshop on Access and Benefit Sharing of Sustainable Development , Sarawak Biodiversity Center , Genetic Resources ( ï쳌¡ ï쳌¢ ï쳌³ ) , Awana , Malaysia . Kuching , Malaysia . F ï쳌¡ ï쳌³ ï쳌© ï쳌¨ ï쳌µ ï쳌¤ ï쳌¤ ï쳌© ï쳌® A . and I . G ï쳌¨ ï쳌¡ ï쳌º ï쳌¡ ï쳌¬ ï쳌¬ ï쳌¹ . ï?? ï?? ï?? ï?? . Medicinal plants L ï쳌© ï쳌­ Y.M . , A . A ï쳌¢ ï쳌¤ ï쳌µ ï쳌¬ M ï쳌¡ ï쳌® ï쳌¡ ï쳌¦ , A.W . N ï쳌¯ ï쳌² ï쳌¨ ï쳌¡ ï쳌­ ï쳌¯ ï쳌­ , M.S . used by Iban Community in Sarawak . p . ï?? ï?? ï?? â?? ï?? ï?? ï?? in Z . K ï쳌¡ ï쳌­ ï쳌¡ ï쳌² ï쳌µ ï쳌¤ ï쳌¤ ï쳌© ï쳌® , A . F ï쳌¡ ï쳌µ ï쳌ª ï쳌¡ ï쳌® , and L . N ï쳌¯ ï쳌² ï쳌¤ ï쳌© ï쳌® . ï?? ï?? ï?? ï?? . Anti - Z ï쳌µ ï쳌² ï쳌© ï쳌¡ ï쳌´ ï쳌© , Y . N ï쳌© ï쳌« I ï쳌¤ ï쳌² ï쳌© ï쳌³ , M . S . I ï쳌« ï쳌² ï쳌¡ ï쳌­ , and D . L ï쳌¡ ï쳌© ï쳌¬ ï쳌¹ ( eds . ) tumor promoting activities and antioxidant effect of Interdisciplinary approaches in natural product sci - th Malaysian traditional vegetables â?? ulam â?쳌 . p . ï?? ï?? ï?? â?? ï?? ï?? ï?? in Z . ences . Proc . ï?? ï?? Ann . Seminar Natural Products Research Z ï쳌µ ï쳌² ï쳌© ï쳌¡ ï쳌´ ï쳌© , Y . N ï쳌© ï쳌« I ï쳌¤ ï쳌² ï쳌© ï쳌³ , M . S . I ï쳌« ï쳌² ï쳌¡ ï쳌­ , and D . L ï쳌¡ ï쳌© ï쳌¬ ï쳌¹ ( eds . ) Malaysia , Bangi , Malaysia . Interdisciplinary approaches in natural product sciences . H ï쳌¡ ï쳌³ ï쳌¨ ï쳌© ï쳌­ Y . , M . Sri N ï쳌µ ï쳌² ï쳌¥ ï쳌³ ï쳌´ ï쳌² ï쳌© , and M . S ï쳌¨ ï쳌¡ ï쳌¨ ï쳌© ï쳌­ ï쳌© . ï?? ï?? ï?? ï?? . An th Proc . ï?? ï?? Annual Seminar on Natural Products Research investigation into the analgesic and anaesthetic effects of in Malaysia , ï?? ï?? â?? ï?? ï?? October ï?? ï?? ï?? ï?? , Bangi , Malaysia . the plant Trema orientalis . p . ï?? ï?? â?? ï?? ï?? in M . S . I ï쳌« ï쳌² ï쳌¡ ï쳌­ , Z . M ï쳌¯ ï쳌¨ ï쳌¡ ï쳌­ ï쳌¡ ï쳌¤ O . ï?? ï?? ï?? ï?? . Access and benefit sharing of genetic Z ï쳌µ ï쳌² ï쳌© ï쳌¡ ï쳌´ ï쳌© , and H . H ï쳌¡ ï쳌² ï쳌µ ï쳌® ( eds . ) Bioassay guided isola - th resources : International imperatives and national needs . tion of natural products . Proc . ï?? ï?? Annual Seminar and Bull . of the Genetics Society of Malaysia ï?? : ï?? â?? ï?? ï?? . ï쳌µ ï쳌® ï쳌¥ ï쳌³ ï쳌£ ï쳌¯ Reg . Workshop on Bioassay Guided Isolation of Natural Products , Bangi , Malaysia . M ï쳌¯ ï쳌¨ ï쳌¡ ï쳌­ ï쳌¡ ï쳌¤ O . , P . M ï쳌¡ ï쳌® ï쳌³ ï쳌¯ ï쳌² , and M . A ï쳌­ ï쳌© ï쳌® ï쳌µ ï쳌¤ ï쳌¤ ï쳌© ï쳌® . ï?? ï?? ï?? ï?? . Potential crops from the wild . p . ï?? ï?? ï?? â?? ï?? ï?? ï?? in A.H . Z ï쳌¡ ï쳌« ï쳌² ï쳌© H ï쳌¯ C.C . , N.S . L ï쳌¡ ï쳌© , L.Y.C . V ï쳌¯ ï쳌¯ ï쳌® , S . D ï쳌¡ ï쳌© ï쳌­ , H.Y . C ï쳌¨ ï쳌¥ ï쳌¡ ï쳌¨ , ( ed . ) Prospects in biodiversity prospecting . Genetics and C.W . L ï쳌¯ . ï?? ï?? ï?? ï?? . Microbial biodiversity in Malaysia Society of Malaysia / Universiti Kebangsaan Malaysia , and the screening for novel drugs . p . ï?? ï?? in T.K . C ï쳌¨ ï쳌µ ï쳌¡ Kuala Lumpur , Malaysia . and E.Y.E . L ï쳌¥ ï쳌¥ ( eds . ) Biodiversity ï?? ï?? ï?? ï?? Kuching . Proc . International Conference on Prudent Biodiversity M ï쳌¯ ï쳌¨ ï쳌¡ ï쳌­ ï쳌¡ ï쳌¤ O . , A . R ï쳌µ ï쳌« ï쳌¡ ï쳌¹ ï쳌¡ ï쳌¨ , I . S ï쳌¡ ï쳌¬ ï쳌­ ï쳌¡ , and O . K ï쳌¡ ï쳌­ ï쳌¡ ï쳌² ï쳌© ï쳌¡ ï쳌¨ . Management and Sustainable Development , Sarawak ï?? ï?? ï?? ï?? . Indigenous fruits of Malaysia and their potential . Biodiversity Center , Kuching , Malaysia . The Malayan Forester ï?? ï?? : ï?? ï?? â?? ï?? ï?? ï?? . I ï쳌« ï쳌² ï쳌¡ ï쳌­ M.S . , Y . N ï쳌© ï쳌« I ï쳌¤ ï쳌² ï쳌© ï쳌³ , S . M ï쳌¯ ï쳌¨ ï쳌¤ . W ï쳌¡ ï쳌¨ ï쳌© ï쳌¤ , Z . Z ï쳌µ ï쳌² ï쳌© ï쳌¡ ï쳌´ ï쳌© , M . ï쳌­ ï쳌¯ ï쳌³ ï쳌´ ï쳌¥ ï?? ï?? ï?? ï?? . Assessment of biological diversity in Malaysia . R ï쳌¡ ï쳌¨ ï쳌­ ï쳌¡ ï쳌¨ , and Z . S ï쳌© ï쳌´ ï쳌© H ï쳌¡ ï쳌ª ï쳌¡ ï쳌² . ï?? ï?? ï?? ï?? . Cytotoxic effect Ministry of Science , Technology and the Environment , of some Malaysian medicinal plants . p . ï?? ï?? â?? ï?? ï?? in M.S . Malaysia . ï?? ï?? ï?? p . ï?? ï?? ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? ï?? : M ï쳌¡ ï쳌¬ ï쳌¡ ï쳌¹ ï쳌³ ï쳌© ï쳌³ ï쳌¡ O ï쳌¨ C . ï?? ï?? ï?? ï?? . Access , benefit - sharing and intellectual prop - U ï쳌¢ ï쳌¡ ï쳌© ï쳌¤ ï쳌© ï쳌¬ ï쳌¬ ï쳌¡ ï쳌¨ M . , I . Z ï쳌¨ ï쳌¡ ï쳌² ï쳌© , and I . N ï쳌¯ ï쳌² ï쳌¨ ï쳌¡ ï쳌¹ ï쳌¡ ï쳌´ ï쳌© , and S . I ï쳌³ ï쳌­ ï쳌¡ ï쳌© ï쳌¬ . ï?? ï?? ï?? ï?? . Theophylline from Malphigia coccigera L . p . erty rights â?? Developing a Malaysian perspective . ï쳌· ï쳌· ï쳌¦ ï?? ï?? ï?? â?? ï?? ï?? ï?? in M.S . I ï쳌« ï쳌² ï쳌¡ ï쳌­ and D . L ï쳌¡ ï쳌© ï쳌¬ ï쳌¹ ( eds . ) Systematic Malaysia Briefing Paper , June ï?? ï?? ï?? ï?? . ï쳌· ï쳌· ï쳌¦ Malaysia , identification of natural products . Proc . ï쳌µ ï쳌® ï쳌¥ ï쳌³ ï쳌£ ï쳌¯ Sub - Kuala Lumpur , Malaysia . Regional Seminar / Workshop on Systematic Identification O ï쳌¨ C . ï?? ï?? ï?? ï?? . A preliminary assessment of access and benefit of Natural Products , Bangi , Malaysia . sharing measures in Malaysia . ï쳌· ï쳌· ï쳌¦ Malaysia Discussion V ï쳌© ï쳌­ ï쳌¡ ï쳌¬ ï쳌¡ S . , A . M ï쳌¯ ï쳌¨ ï쳌¤ , I ï쳌¬ ï쳌¬ ï쳌¨ ï쳌¡ ï쳌­ and A . A ï쳌¢ ï쳌¤ ï쳌µ ï쳌¬ ï쳌¬ R ï쳌¡ ï쳌³ ï쳌¨ ï쳌© ï쳌¨ . Paper , ï쳌· ï쳌· ï쳌¦ Malaysia , Kuala Lumpur , Malaysia . ï?? ï?? ï?? ï?? . Antioxidant activity in Malaysian ulam . p . ï?? ï?? â?? ï?? ï?? O ï쳌´ ï쳌¨ ï쳌­ ï쳌¡ ï쳌® R . and W.M . L ï쳌¯ ï쳌¦ ï쳌´ ï쳌© . ï?? ï?? ï?? ï?? . The status of marine in Z . Z ï쳌µ ï쳌² ï쳌© ï쳌¡ ï쳌´ ï쳌© , Y . N ï쳌© ï쳌« I ï쳌¤ ï쳌² ï쳌© ï쳌³ , M . S . I ï쳌« ï쳌² ï쳌¡ ï쳌­ , and D . L ï쳌¡ ï쳌© ï쳌¬ ï쳌¹ biodiversity in Malaysia . p . ï?? ï?? â?? ï?? ï?? in A.H . Z ï쳌¡ ï쳌« ï쳌² ï쳌© ( ed . ) ( eds . ) Interdisciplinary Approaches in Natural Product Prospects in biodiversity prospecting . Genetics Society th Sciences . Proc . ï?? ï?? Ann . Seminar Natural Products of Malaysia / Universiti Kebangsaan Malaysia , Kuala Research Malaysia , Bangi , Malaysia . Lumpur , Malaysia . Z ï쳌¡ ï쳌µ ï쳌¹ ï쳌¡ ï쳌¨ Y . , J . S ï쳌´ ï쳌¡ ï쳌® ï쳌³ ï쳌¬ ï쳌¡ ï쳌³ , and L.P . A ï쳌º ï쳌© ï쳌­ ï쳌¡ ï쳌¨ ï쳌´ ï쳌¯ ï쳌¬ H ï쳌¡ ï쳌· ï쳌¡ ï쳌² ï쳌© ï쳌¡ ï쳌¨ . S ï쳌¡ ï쳌­ T.W . , A.S . N ï쳌§ , P.B . C ï쳌¨ ï쳌¥ ï쳌¡ ï쳌¨ , and K.S . O ï쳌® ï쳌§ . ï?? ï?? ï?? ï?? . ï?? ï?? ï?? ï?? . Antiproliferative effect of Goniothalamin on three Toxicity screening with the brine shrimp ( Artemia salina ) different human breast cancer cell lines . p . ï?? ï?? â?? ï?? ï?? in M.S . of plant extracts . p . ï?? ï?? â?? ï?? ï?? in M.S . I ï쳌« ï쳌² ï쳌¡ ï쳌­ and D . L ï쳌¡ ï쳌© ï쳌¬ ï쳌¹ I ï쳌« ï쳌² ï쳌¡ ï쳌­ , Z . Z ï쳌µ ï쳌² ï쳌© ï쳌¡ ï쳌´ ï쳌© , and H . H ï쳌¡ ï쳌² ï쳌µ ï쳌® ( eds . ) Bioassay guided ( eds . ) Systematic identification of natural products . Proc . isolation of natural products . Proc . ï?? ï?? th Ann . Seminar ï쳌µ ï쳌® ï쳌¥ ï쳌³ ï쳌£ ï쳌¯ Sub - Regional Seminar / Workshop on Systematic and ï쳌µ ï쳌® ï쳌¥ ï쳌³ ï쳌£ ï쳌¯ Regional Workshop on Bioassay Guided Identification of Natural Products , Bangi , Malaysia . Isolation of Natural Products , Bangi , Malaysia . Endnotes 1 Indigenous or local community means any group of individuals ï쳌§ ï쳌­ ï쳌¯ â?? s regulation took precedence . The ï?? ï?? st Meeting of the ï쳌¡ ï쳌³ ï쳌¥ ï쳌¡ ï쳌® Ministers for Agriculture and Forestry held on ï?? ï?? â?? ï?? ï?? October ï?? ï?? ï?? ï?? who have one or more of the following characteristics or that falls in Bandar Seri Begawan , Brunei Darussalam , endorsed the ï쳌¡ ï쳌³ ï쳌¥ ï쳌¡ ï쳌® within any of the following definitions : a group of individuals who Guidelines on Risk Assessment of Agriculture - Related Genetically occupy or occupied a particular territory for many generations , and Modified Organisms . whose cultural and economic traditions are integrally connected 6 to their occupation and customary uses of those territories ; an In order to ensure uniformity in the administration of the law , it aborigine or aboriginal community as defined in the Aboriginal is important to have close cooperation between the competent Peoples Act ï?? ï?? ï?? ï?? ; and the natives of Sabah and Sarawak as defined authorities of the Federal and State Governments . by Article ï?? ï?? ï?? ( ï?? ) and ( ï?? ) of the Federal Constitution . 7 These benefits are listed by the â?? Access to Genetic Resources Bill . â?쳌 2 The National Policy on Biological Diversity aims to provide the 8 The Access to Genetic Resources Bill states that the competent direction for Malaysia to implement ï?? ï?? strategies through vari - authority may formulate guidelines for the exemption of research - ous action plans until the year ï?? ï?? ï?? ï?? . There are no specific time ers from local academic and research institutions involved in the periods indicated for the strategies ; neither are the implementing conduct of noncommercial research from the provisions of the Bill , institutions or agencies identified . However , the Governmentâ??s provided always that such exemption is without prejudice to the goals have been further enhanced by the setting up of the National right of the competent authority to withdraw the exemption where Biodiversity and Biotechnology Council chaired by Hon . Deputy appropriate . Prime Minister in December ï?? ï?? ï?? ï?? . 9 This is intended for Malaysians who want to apply for access for 3 http : / / www.arbec.com.my / NBP.pdf noncommercial purposes . 4 10 This is the Malay term for Chief Minister of a State . As handed This ( the Ministryâ??s ) position has emerged as a result of reviewing down in history , Malaysia , in brief , comprises two â?? types â?쳌 of several draft laws from other countries , such as India , and is likely States : a ) Federated Malay States and b ) Unfederated Malay States . to be the position supported by the Government . 11 The former States are those which had never been ruled directly by This ( the Ministryâ??s ) position came into focus after the final text the British ( e.g . , Kedah , Kelantan ) , while the latter have had direct of the draft Access to Genetic Resources Bill , and therefore , the British administration / intervention ( Penang , Malacca , Sabah , and position and the three circumstances are not stated in the Bill . No Sarawak ) . Thus , the former have Menteri Besars while the latter distinction is made in the access procedure to differentiate between have Chief Ministers . Both have equal powers . the three different circumstances . 5 12 In ï?? ï?? ï?? ï?? , there was an initiative to develop the ï쳌¡ ï쳌³ ï쳌¥ ï쳌¡ ï쳌® Framework The application for an access license shall include , among other things , ï쳌° ï쳌© ï쳌£ in writing and certified by the resource provider . The Agreement on Access to Genetic Resources but it has seen little competent authority shall establish an appropriate process for progress . Thus far , this initiative has provided little or no bearing securing ï쳌° ï쳌© ï쳌£ of the resource provider that may be affected by the on our efforts to develop a national law or policy on access to application . The process shall be prescribed by the competent genetic resources . The question of whether something similar to authority , after consultation with relevant parties , in order to ensure that of the Andean Community regional legislation was appropriate and verify that ï쳌° ï쳌© ï쳌£ is properly obtained . The consultation procedure for ï쳌¡ ï쳌³ ï쳌¥ ï쳌¡ ï쳌® had been raised in many discussions , perhaps leading shall include , but is not limited to , the following measures : a ) to what is now the proposal for the ï쳌¡ ï쳌³ ï쳌¥ ï쳌¡ ï쳌® Framework Agreement participation of representatives of the indigenous and local com - on Access to Genetic Resources . There was already a model that munities and b ) wide and effective dissemination of all the relevant ï쳌¡ ï쳌³ ï쳌¥ ï쳌¡ ï쳌® could have looked at for this purpose . However , what was information to the concerned communities and other interested really seen as more important was the harmonization of national parties on the proposed access activity . At this point in time , such laws and policies , since many countries share similar biological di - an appropriate procedure has yet to be established . versity . The priorities accorded to the matter ( i.e . , access to genetic 13 resources ) by countries were also a factor , since the matter of ï쳌§ ï쳌­ ï쳌¯ s The competent authority has not yet been determined . The draft was seen as more urgent . Therefore , a regional harmonization for Bill provides for the two options previously mentioned . ï?? ï?? ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ 14 The scope of the draft legislation covers biological resources , of the traditional knowledge ) . 15 found both in in situ conditions and ex situ collections , on public This is a term used by plant breeders to describe plants which are lands , communal or customary lands , and alienated or private selected from seedlings , usually not out of planned hybridization , lands . In the case of access to biological resources , where the and these plants are later cloned for further breeding use . land comes under the Federal jurisdiction , the competent federal 16 Foreign scientists who want to apply for access to genetic authority shall negotiate on the benefits . Where the land comes resources are required to have a local collaborator or sponsor . A under the State jurisdiction , the competent authority shall negotiate similar requirement has already been put in place by the Sarawak on the benefits . As for communal or customary lands , and alien - Biodiversity Center Ordinance of ï?? ï?? ï?? ï?? and Sabah Biodiversity ated or private lands , the competent State authority may take into Enactment of ï?? ï?? ï?? ï?? . account relevant factors as may be appropriate ( such as the status 17 of endemism or rarity of the biological resource , conservation The two options were proposed by the Task Force on Access to status , existing and potential value and use , and whether tradi - Genetic Resources after consultative discussions . tional knowledge is involved ) , including the resource provider , in 18 In drafting the Access to Genetic Resources Bill , there was always determining the nature and combination of benefits in accordance active participation and strong input by the representative of the with the merits of each case . In the case of access to traditional Ministry of Consumer Affairs with respect to the need to review the knowledge , the competent authority may take into account relevant Patent Act of ï?? ï?? ï?? ï?? vis - à - vis the access bill . factors ( such as whether the knowledge is in common use by large 19 Personal communication with Rozina Ayob of the Ministry of sections of the population , whether the knowledge can be attributed Science , Technology and the Environment , Malaysia on ï?? ï?? â?? ï?? ï?? to a particular indigenous or local community , the number of com - munities involved in the conservation and use , and the uniqueness October ï?? ï?? ï?? ï?? . ï?? ï?? ï?? 12 Legal Issues Regarding the International Regime : Objectives , Options , and Outlook Tomme Rosanne Young 5 The years ï?? ï?? ï?? ï?? â?? ï?? ï?? ï?? ï?? have seen some of the most dynamic Work ( ï쳌­ ï쳌¹ ï쳌° ï쳌¯ ï쳌· ) for the Convention ( March ï?? ï?? ï?? ï?? ) 1 action in the realm of access and benefit sharing ( ï쳌¡ ï쳌¢ ï쳌³ ) which integrated an adapted version of a provision under the Convention on Biological Diversity ( ï쳌£ ï쳌¢ ï쳌¤ ) since of the ï쳌· ï쳌³ ï쳌³ ï쳌¤ Plan of Implementation , calling for 2 the convention was adopted in ï?? ï?? ï?? ï?? . Key decisions within the parties to consider the process , nature , scope , this time frame include : elements , and modalities of an international regime and provide advice on how it may wish to address â?¢ ï쳌£ ï쳌¢ ï쳌¤ - Conference of the Parties ( ï쳌£ ï쳌¯ ï쳌° ) Decision ï쳌¶ ï쳌© - this issue ; and 3 ï?? ï?? ( March ï?? ï?? ï?? ï?? ) , at which the voluntary Bonn 6 Guidelines on Access to Genetic Resources and â?¢ ï쳌£ ï쳌¢ ï쳌¤ ï쳌£ ï쳌¯ ï쳌° Decision ï쳌¶ ï쳌© ï쳌© / ï?? ï?? , which sets the Terms Fair and Equitable Sharing of the Benefits Arising of Reference for the process of negotiating that out of their Utilization ( hereafter Bonn Guidelines ) regime . were adopted in a decision that clearly requires The ï쳌¡ ï쳌¢ ï쳌³ issue , however , has long suffered from critical the Parties to keep this document under review limitations inhibiting national implementation . Key issues and also to undertake additional work regarding of interpretation of the ï쳌£ ï쳌¢ ï쳌¤ and of the application of exist - key definitions and concepts relating to ï쳌¡ ï쳌¢ ï쳌³ more ing legal and institutional systems to new concepts have generally ; proven to be a significant stumbling block to the creation â?¢ Plan of Implementation of the World Summit on of a functional ï쳌¡ ï쳌¢ ï쳌³ system . 4 Sustainable Development ( ï쳌· ï쳌³ ï쳌³ ï쳌¤ ) ( September , Hence it is not enough simply to make the decision ï?? ï?? ï?? ï?? ) , which called on all countries to â?? negotiate to go forward with new negotiations . It is essential that within the framework of the ï쳌£ ï쳌¢ ï쳌¤ , bearing in mind underlying legal concepts be clarified , and practical imple - the Bonn Guidelines , an international regime to mentation measures identified , so that the negotiators and promote and safeguard the fair and equitable policy makers can base their work on a clear understand - sharing of benefits arising out of the utilization of ing of what is possible and what it will cost in money , genetic resources â?쳌 ; manpower , and other trade - offs to bring an effective ï쳌¡ ï쳌¢ ï쳌³ â?¢ The ï쳌£ ï쳌¢ ï쳌¤ meeting on the Multi - Year Programme of system to life . Opening Comment : The International Regime One of the first points that must be made in any discussion guidelines , and other instruments , as well as both regional and national implementation measures . Internationally , the of the negotiation of an international regime on access and 7 most commonly mentioned documents and institutions , in benefit sharing is that a regime already exists . Although addition to the ï쳌£ ï쳌¢ ï쳌¤ , that comprise the international regime its coverage is extremely â?? patchy â?쳌 in many ways , the are the International Treaty on Plant Genetic Resources for regime includes a variety of international laws , policies , ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ 8 Food and Agriculture ( ï쳌© ï쳌´ ï쳌° ï쳌§ ï쳌² ï쳌¦ ï쳌¡ ) , the World Intellectual question is â?? what kind of instrument will be added to this mix â?? interpretation , protocol , annex , guideline , or ï쳌£ ï쳌¯ ï쳌° Property Organization ( ï쳌· ï쳌© ï쳌° ï쳌¯ ) system , and the Bonn Decision ? â?쳌 From a legal perspective , however , the type Guidelines . However , the Seventh Conference of the of instrument that is developed is perhaps less important Parties to the ï쳌£ ï쳌¢ ï쳌¤ ( ï쳌£ ï쳌¯ ï쳌° - ï?? ) has identified at least ï?? ï?? other than its particular characteristics . In this connection , this international instruments that must be evaluated to deter - paper should start by considering the frequent discussions mine how they fit into the regime . about whether it should be binding or voluntary . This ques - At the regional level , the best publicized components tion blends two concepts â?? binding versus nonbinding and of the regime have been Decision ï?? ï?? ï?? of the Andean voluntary versus mandatory . Community of Nations on access and benefit - sharing processes and procedures ( A ï쳌® ï쳌¤ ï쳌¥ ï쳌¡ ï쳌® C ï쳌¯ ï쳌­ ï쳌­ ï쳌µ ï쳌® ï쳌© ï쳌´ ï쳌¹ ï?? ï?? ï?? ï?? ) , Binding and Nonbinding Provisions the European Unionâ??s Directive ï?? ï?? / ï?? ï?? on disclosure of origin of biological sources of natural material in In international law , binding refers to a commitment by 9 biotechnological inventions , and the Organization of a country to take a particular action . Often , binding com - African Unityâ??s adoption of the the African Model Law mitments are expressed in language that â?? softens â?? their for the Protection of the Rights of Local Communities , impact ( â?? endeavor to regulate â?쳌 , rather than â?? regulate â?쳌 ) or Farmers , and Breeders , and for the Regulation of Access that recognizes priority among commitments ( â?? subject to to Biological Resources . available resources â?쳌 ) . It should be noted that these soften - On the national level , eighteen countries have so far ers do not affect the binding nature of the commitment . adopted access and benefit - sharing legislation or other The countries continue to be obligated to make a â?? good instruments that directly address some or all of the ï쳌¡ ï쳌¢ ï쳌³ - faith â?? ( e.g . , nontoken ) effort to comply , and will be in related commitments under the ï쳌£ ï쳌¢ ï쳌¤ ( C ï쳌¡ ï쳌¢ ï쳌² ï쳌¥ ï쳌² ï쳌¡ ï?? ï?? ï?? ï?? ) . A violation otherwise . Nonbinding international instruments number of other countries have asserted that their exist - may be adopted as guidelines and declarations , but the ing national legislation adequately addresses ï쳌¡ ï쳌¢ ï쳌³ matters , governments involved specifically state that they are not although initial evaluation suggests that many of these committing to take these actions . 10 claims should be more clearly examined . At the national level , binding refers to whether a com - In addition , contractual agreements for access and mitment has legal effect . A promise to pay money , for benefit sharing must also be considered to be part of the example , may be binding ( if it is a part of a contract in regime . This is not only because these instruments are which another party has made commitments or taken ac - 11 adopted and interpreted under national ï쳌¡ ï쳌¢ ï쳌³ systems , tion ) , or nonbinding ( if it is simply an indication of intent but also because they are often directly negotiated by at or a statement made to convince a beggar or borrower to 12 least one government . As such , their interpretation ( in â?? go away and try again tomorrow â?쳌 ) . practice and through the courts ) is a critical input into the regime . Voluntary and Mandatory This leads to a basic question : What exactly is meant by the phrase â?? negotiate an international regime on [ ac - By contrast , the concepts of voluntary and mandatory refer cess and ] benefit sharing â?? ? Although the final decisions to a different kind of legal question â?? the contrast between about what and how will be negotiated will not be made what one may do and what one must do . Laws are typically for some time , a few observations ( based on facts and seen to fit into three categories â?? enabling laws ( telling the 13 research set forth in the rest of the paper ) are warranted . regulated public what they are permitted to do â?? these First , the international regime itself cannot be negotiated express voluntary options ) , mandatory laws ( telling the in its entirety . Even if the ï쳌£ ï쳌¢ ï쳌¤ â?? s entire existing provisions regulated public what they must do ) , and prohibitory laws regarding access were completely renegotiated , this action ( telling the regulated public what they cannot do ) . would still not impact the following : Within particular areas of law , there are also voluntary ( enabling ) , mandatory , and prohibitory components . In the â?¢ Other international instruments ; area of private contracts , for example , the law specifies â?¢ National implementing instruments ; that only certain kinds of contracts are legally enforce - â?¢ Existing contracts ; and able â?? those in which : â?¢ The legal interpretations developed from applying â?¢ Both parties are informed of all relevant informa - and interpreting existing contracts and other instru - tion ( i.e . , no party intentionally or inadvertently ments . lied or concealed facts relevant to the contract ) ; â?¢ Both parties are reasonably interpreting the contract Contrary to many statements , the current choice is not terms and agree on what those terms mean ; and between â?? negotiating an entirely new regime â?? and â?? nego - tiating a parts or interpretations of the regime â?? , because â?¢ Both parties have given or are committed to giving any negotiation will involve only part of the regime . The consideration ( payment of money , performance or regime is and will be a combination of established and abstention from some action , giving of tangible or new instruments , concepts , and principles . The only intangible items or rights , etc . ) . ï?? ï?? ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? ï?? : L ï쳌¥ ï쳌§ ï쳌¡ ï쳌¬ I ï쳌³ ï쳌³ ï쳌µ ï쳌¥ ï쳌³ ï쳌¡ ï쳌® ï쳌¤ ï쳌´ ï쳌¨ ï쳌¥ I ï쳌® ï쳌´ ï쳌¥ ï쳌² ï쳌® ï쳌¡ ï쳌´ ï쳌© ï쳌¯ ï쳌® ï쳌¡ ï쳌¬ R ï쳌¥ ï쳌§ ï쳌© ï쳌­ ï쳌¥ These three elements are mandatory in all contracts â?? that they do not affect the application of the ultimate laws . The same is true where a country decides to adopt a law that is , the law will not enforce a purported contract with - recommended in a nonbinding international instrument . out them . However , there are many voluntary elements of In either case , where a country meets its binding obliga - contract law . Initially , it must be an absolutely voluntary tion to adopt a law , that law applies to all members of the choice to enter a contract or not . The law will not enforce a regulated public according to the terms of the law ( if the contract if either party was forced to enter into the contract law says that it is mandatory , it is mandatory . ) The lawâ??s against his will . The terms of the contract are negotiated effect is not altered by the fact that the country was not by the parties â?? thus the selection of terms is voluntary . internally obligated to adopt it . In some cases , however , the law will identify â?? standard Similarly , where legislation creates a set of voluntary terms â?? â?? it may say , for example , that in payment - for - ser - contractual provisions , the parties have a choice about vices contracts , payment will be owing after the services whether to adopt those provisions or not . However , once are provided , unless otherwise provided in the contract . the parties have exercised that option and included some This is a voluntary provision . The parties may adopt an - of these provisions in a binding contract , then they are other payment option , however , if they donâ??t specify the enforceable obligations , no different from other terms of order of payment , the law will assume the order is services the contract . As further discussed below , nearly all of the first , money second . There are also many prohibitory ele - ï쳌¡ ï쳌¢ ï쳌³ - related provisions in the ï쳌£ ï쳌¢ ï쳌¤ are legally binding on ments of contract law . For example , in most countries , a the countries that are part of the ï쳌£ ï쳌¢ ï쳌¤ . Similarly , the state - contract provision that sets excessive interest ( usury ) or ment that the provisions of the Bonn Guidelines are vol - that forces a party to take action against his will ( extortion ) untary â?? only means that the parties have a choice between may not be enforced . these provisions and other approaches , in their efforts to Mandatory , Binding , Voluntary , and implement the binding provisions of the ï쳌£ ï쳌¢ ï쳌¤ . Nonbinding Components of the Regime The most important point relating to both of these con - cepts ( binding / nonbinding and voluntary / mandatory ) is The Current Situation : ABS and the Bonn Guidelines As a basis for substantive analysis , this section sum - â?¦ with the aim of sharing in a fair and equitable way marizes the ï쳌¡ ï쳌¢ ï쳌³ issue , its role in the ï쳌£ ï쳌¢ ï쳌¤ , and the issues , the benefits arising from the commercial and other concerns , and processes that led to the adoption of the utilization of genetic resources with the Contracting Bonn Guidelines . This summary is not designed to be a Party providing such resources â?쳌 ( Art . ï?? ï?? . ï?? ) . complete description , but instead to provide an idea of what â?¢ â?? take legislative , administrative , or policy mea - the international regime will seek to create and foster . sures , â?¦ with the aim of sharing in a fair and equi - table way â?¦ the results of research , development ABS in the CBD arising from the commercial and other utilization of genetic resources with the Contracting Party Most commentators begin by noting that ï쳌¡ ï쳌¢ ï쳌³ is the heart providing such resources â?쳌 ( Art . ï?? ï?? . ï?? ) . of the third primary objective of the ï쳌£ ï쳌¢ ï쳌¤ , which calls for â?¢ â?? take legislative , administrative , or policy mea - â?? fair and equitable sharing of the benefits arising out of 14 sures , â?¦ with the aim that â?¦ developing countries , the utilization of genetic resources â?쳌 . However , within which provide genetic resources , are provided ac - the ï쳌£ ï쳌¢ ï쳌¤ , ï쳌¡ ï쳌¢ ï쳌³ is more than just an aspiration . Although this cess to and transfer of technology which makes use fact is often overlooked in discussions , the ï쳌£ ï쳌¢ ï쳌¤ contains ï?? ï?? 15 of those resources , â?¦ including technology pro - separate , non - optional obligations relating to ï쳌¡ ï쳌¢ ï쳌³ . These ï?? ï?? obligations , in the order they appear in the ï쳌£ ï쳌¢ ï쳌¤ , are : tected by patents and other intellectual property rights â?¦ â?쳌 ( Art . ï?? ï?? . ï?? ) . â?¢ â?? create conditions to facilitate access to genetic resources for environmentally sound uses by â?¢ â?? facilitate the exchange of information , from all other Contracting Parties and not to impose re - publicly available sources , â?¦ taking into account strictions that run counter to the objectives of this the special needs of developing countries . â?¦ Such Convention â?쳌 ( Art . ï?? ï?? . ï?? ) . exchange of information shall â?¦ where feasible , include repatriation of information â?쳌 ( Arts . ï?? ï?? . ï?? and â?¢ â?? develop and carry out scientific research based on ï?? ) . genetic resources provided by other Contracting Parties with the full participation of , and where â?¢ â?? take legislative , administrative , or policy mea - possible in , such Contracting Parties â?쳌 ( Art . ï?? ï?? . ï?? ) . sures , â?¦ to provide for the effective participation â?¢ â?? take legislative , administrative , or policy measures , in biotechnological research activities by those ï?? ï?? ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ 19 Contracting Parties , especially developing coun - ronmentally sound uses by other Contracting Parties â?¦ â?쳌 . tries , which provide the genetic resources for such Parties are clearly allowed to adopt domestic ï쳌¡ ï쳌¢ ï쳌³ frame - research , and where feasible in such Contracting works , of course , ( and in fact , the adoption of compre - Parties â?쳌 ( Art . ï?? ï?? . ï?? ) . hensive frameworks for all genetic resource issues may be necessary to make the international system effective ) but â?¢ â?? take all practicable measures to promote and the Convention specifically does not cover them . advance priority access on a fair and equitable ba - Hence , it is essential ( and mandatory ) that all sis by Contracting Parties , especially developing Contracting Parties must adopt the various kinds of mea - countries , to the results and benefits arising from sures and take the other actions described above . In this biotechnologies based upon genetic resources pro - connection , it is also useful to note that ï쳌¡ ï쳌¢ ï쳌³ is only one of vided by those Contracting Parties â?쳌 ( Art . ï?? ï?? . ï?? ) . the genetic - resource - related issues addressed in the ï쳌£ ï쳌¢ ï쳌¤ . â?¢ â?? provide , in accordance with its capabilities , fi - As further discussed below , it is possible that the provisions nancial support and incentives in respect of those on ï쳌¡ ï쳌¢ ï쳌³ should be viewed in conjunction with the provisions national activities which are intended to achieve addressing agriculture , biosafety , and Genetically Modified the objectives of this Convention â?¦ â?쳌 ( Art . ï?? ï?? . ï?? ) . Organisms ( ï쳌§ ï쳌­ ï쳌¯ s ) , and with subsequent work on these â?¢ â?? developed country Parties â?¦ provide , and develop - issues , including the Cartagena Biosafety Protocol that ing country Parties avail themselves of , financial came into force on ï?? ï?? September ï?? ï?? ï?? ï?? and the national resources related to the implementation of this legislation and policy frameworks on biosafety and ï쳌§ ï쳌­ ï쳌¯ s Convention through bilateral , regional , and other that have been developed and are being developed around multilateral channels â?쳌 ( Art . ï?? ï?? . ï?? ) . the world . The existence of these commitments underscores three The Bonn Guidelines basic understandings that will be critical to the rest of this paper , and to the entire discussion of the international re - The Bonn Guidelines were adopted in ï?? ï?? ï?? ï?? , by the Sixth gime : First , the above commitments are not optional . Each Conference of Parties to the ï쳌£ ï쳌¢ ï쳌¤ ( ï쳌£ ï쳌¯ ï쳌° - ï?? ) . Although an party is required to endeavor to take these actions.As noted important first step toward enabling the creation of a net - above , the â?? endeavor â?? language may soften these require - work of national law systems addressing ï쳌¡ ï쳌¢ ï쳌³ issues , the ments for those who try but cannot achieve them , but it Guidelines cannot be seen as a positive development if they does not make the commitments less obligatory . Parties are are perceived to represent a final decision or guidance . In required to try to take the relevant actions , and will only fact , the Bonn Guidelines represent ideas expressed by the be considered to meet these commitments if either a ) the parties , but in many cases , those ideas either have never requirement is fulfilled or b ) the country made a serious been tried in practice or their use has not been made public and significant attempt , but was not able to fulfill it ( due and scrutinized from all perspectives . Hence , these ideas to external preventing factors ) . These requirements will are designed as starting points for national framework de - not be excused by a lack of political will , for example . velopment processes and national ï쳌¡ ï쳌¢ ï쳌³ negotiations , rather Countries having acceded to the ï쳌£ ï쳌¢ ï쳌¤ are required to take than as â?? tried - and - true â?쳌 recipes for implementation . action . A country will have violated the ï쳌£ ï쳌¢ ï쳌¤ unless it has The Guidelines recognize this fact specifically â?? call - made every reasonable effort to adopt measures , or to take ing themselves â?? evolutionary â?쳌 in nature.At their adoption , other required actions , irrespective of whether or not it has the Parties clearly agreed that â?? the Guidelines are intended been successful . to be reviewed and accordingly revised and improved as Second , these commitments are not directly binding experience is gained in access and benefit sharing â?쳌 . In this on individuals , corporations , NGOs , other entities , or first iteration , these Guidelines rely rather substantially on even sub - national ( state and provincial ) governmental information regarding the views of businesses working structures . They bind only the Contracting Parties to the 17 with genetic resources . As such , they appear to answer an CBD â?? that is , the ï?? ï?? ï?? national governments , which must unasked question â?? â?쳌 Why are there only a few ï쳌¡ ï쳌¢ ï쳌³ agree - adopt the relevant measures directly . The only way that any ments ? â?쳌 ( see Chapter ï?? ) . Most do not address developing person , business , NGO , or other entity can become sub - country concerns or conservation / sustainable use issues . ject to the requirements set out in the Convention will be 18 This approach has resulted in a rather strong focus on through national law adopted by each Contracting Party . streamlining national processes and providing forms and And then , the individuals or entities are subject to the lists that will streamline the negotiation and documentation relevant national law , and not directly to the Convention of ï쳌¡ ï쳌¢ ï쳌³ agreements and other relevant instruments . Since or any processes under the Convention . their adoption , the Bonn Guidelines have been relatively Third , these provisions do not address purely domestic controversial . Some parties and participants have been very ï쳌¡ ï쳌¢ ï쳌³ situations ( i.e . , those in which a countryâ??s genetic re - strong in promoting national legislative development , but sources are sampled , studied , and utilized by entities and saying that development should be â?? based on the Bonn activities within the national jurisdiction of that country . ) Guidelines â?쳌 . Other parties have noted that many critical The access requirement , for example , is specifically limited to the facilitation of â?? access to genetic resources for envi - components of necessary national legislation are not dis - ï?? ï?? ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? ï?? : L ï쳌¥ ï쳌§ ï쳌¡ ï쳌¬ I ï쳌³ ï쳌³ ï쳌µ ï쳌¥ ï쳌³ ï쳌¡ ï쳌® ï쳌¤ ï쳌´ ï쳌¨ ï쳌¥ I ï쳌® ï쳌´ ï쳌¥ ï쳌² ï쳌® ï쳌¡ ï쳌´ ï쳌© ï쳌¯ ï쳌® ï쳌¡ ï쳌¬ R ï쳌¥ ï쳌§ ï쳌© ï쳌­ ï쳌¥ cussed in the Bonn Guidelines â?? suggesting that â?? national developed under the framework system . Another type of international instrument is regulatory in style . It contains legislation based on the Bonn Guidelines â?쳌 would be fatally specific requirements , under which each country is obliged flawed . These arguments may be resolved by recalling that , to take clearly identified action . Examples of this kind of according to the terms of the Guidelines themselves , they instrument include the Cartagena Biosafety Protocol , the are voluntary and understanding that the term voluntary : Convention on International Trade in Endangered Species â?¢ Applies only to the Parties ( national governments or ( ï쳌£ ï쳌© ï쳌´ ï쳌¥ ï쳌³ ) , and the Montreal Protocol on Substances that countries ) adopting legislation â?? they have the op - 22 Deplete the Ozone Layer . Where the framework system tion to follow recommendations of the Guidelines is working well , these regulatory - style conventions may or not as they choose . be able to utilize the framework tools , and thus be relieved â?¢ Does not mean that compliance is optional , when of the necessity of separately developing tools and instru - these terms are included in an agreement or a law . ments that are relevant to all instruments within the frame - If national law states that they are mandatory , or if work . A third international element is the development of the contract by which the corporation / entity obtains guidelines and soft law . For example , as noted above the access rights so provides , then the corporation must Bonn Guidelines are not obligatory on any Party , but are comply or it will be in breach of contract . offered only on the chance that they may assist the Parties and others in implementing international objectives . Framework Approaches at International At the national level , a similar structure exists . National and National Levels policy provides overarching guidance and coordination The creation of an international regime involves both in - among national laws , with guidance on national objec - ternational instruments and also the implementation and tives and compliance with regard to and implementation adoption of national legislation based on these interna - of international conventions and obligations . This policy tional decisions and commitments . It is useful to examine provides an idea of the outcomes and objectives toward briefly the components of an international regime and how which legislation should be directed . National laws and they work together . regulations focus more specifically on the actions to be At the international level , â?? policy - style â?? instruments taken to achieve national policy mandates and outcomes , exist which focus on obtaining general agreement among in order to , inter alia , fulfill international commitments . sovereign governments to address key issues . Many of Yet another level of implementation is found in the form 20 these are also â?? framework â?? instruments . The ï쳌£ ï쳌¢ ï쳌¤ is of both hard and soft rules , as well as contracts and other such an instrument . It is different from other international action by the private sector , NGOs , and others . In opti - conventions , in that its object is promoting concerted na - mal situations , this national level pyramid begins to be tional implementation in a programmatic way ( providing developed early in the international process . Together the economies and strengths of collaborative action ) , these processes ( in all relevant forums ) constitute the 21 and with the assistance of so - called â?? framework tools â?쳌 international regime . Why Revise / Reconsider the International Regime ? At this point , it may perhaps not be obvious why the â?? ne - supplemented by the lack of a shared understanding and gotiation of an International Regime â?쳌 was proposed by the clarification of key concepts . The country whose overall ï쳌· ï쳌³ ï쳌³ ï쳌¤ . In simplest terms , the answer is that , even ï?? ï?? years ï쳌¡ ï쳌¢ ï쳌³ regime is generally considered the most successful 23 after the ï쳌£ ï쳌¢ ï쳌¤ was adopted , and despite significant interest ( Costa Rica ) , for example , is rather emphatically not 24 and commitment ( particularly by developing countries ) , replicable . the worldâ??s governments have not been able to create a A great many articles and opinions have been pub - functional ï쳌¡ ï쳌¢ ï쳌³ system . Based on initial detailed research lished and circulated about the reasons behind this lack into existing national and regional legislation on ï쳌¡ ï쳌¢ ï쳌³ and of progress in the development of a functional legislative / initial inquiries into a few available ï쳌¡ ï쳌¢ ï쳌³ agreements , it is administrative system through which ï쳌¡ ï쳌¢ ï쳌³ arrangements clear that there has been a notable lack of progress in ful - can become recognized contractual / property interests and filling the ï쳌¡ ï쳌¢ ï쳌³ - related obligations under the ï쳌£ ï쳌¢ ï쳌¤ ( C ï쳌¡ ï쳌¢ ï쳌² ï쳌¥ ï쳌² ï쳌¡ can develop their potential as components of the â?? biodi - ï?? ï?? ï?? ï?? ) ( see Chapters ï?? , ï?? , and ï?? ) . versity triad â?쳌 . Many of these were stated in the preamble Fewer than ï?? ï?? countries and regional organizations of the Bonn Guidelines and in documents submitted to have adopted specific national ï쳌¡ ï쳌¢ ï쳌³ legislation ( C ï쳌¡ ï쳌¢ ï쳌² ï쳌¥ ï쳌² ï쳌¡ the ï쳌£ ï쳌¯ ï쳌° - ï?? . In general , these sources focus on the fact that ï?? ï?? ï?? ï?? ) , and in most cases there are doubts about whether corporations â?? representatives in ï쳌¡ ï쳌¢ ï쳌³ and Bonn Guideline the legislation has been effective or even fully implemented negotiations strongly indicated a general corporate un - ( P ï쳌¥ ï쳌² ï쳌© ï쳌¡ ï?? ï?? ï?? ï?? ) . The basic theory of this paper is that the willingness to pay the transaction cost associated with failure to progress on the implementation of an effective negotiating ï쳌¡ ï쳌¢ ï쳌³ arrangements under existing national leg - ï쳌¡ ï쳌¢ ï쳌³ system is tied to incorrect concepts and assumptions , islation ( often described as overly complex and demand - ï?? ï?? ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ 25 ing ) . Hence , relying on this industry perspective , many ( who are not contractually related ) usually cannot commentators ( and the Bonn Guidelines ) suggest solutions be effectively protected through this system . proposed by these sources focus on simplifying national As further discussed below , genetic resources do not legislation , minimizing national legislative requirements , appear to fit in either category . They do not appear to be streamlining governmental processes , and harmonizing the tangible , given that they are based on ï쳌¤ ï쳌® ï쳌¡ and ï쳌² ï쳌® ï쳌¡ ( sub - countries â?? various approaches to domestic requirements , stances which , under generally promulgated theories of 26 such as public participation ( ï쳌´ ï쳌¥ ï쳌® K ï쳌¡ ï쳌´ ï쳌¥ and L ï쳌¡ ï쳌© ï쳌² ï쳌¤ ï?? ï?? ï?? ï?? , life , are thought to be the information from which any life S ï쳌· ï쳌© ï쳌¤ ï쳌¥ ï쳌² ï쳌³ ï쳌« ï쳌¡ ï?? ï?? ï?? ï?? ) . form can be synthesized ) . The use of genetic resources , 27 Research under the ï쳌© ï쳌µ ï쳌£ ï쳌® ï쳌¡ ï쳌¢ ï쳌³ Project suggests the ownership implications that arise from the fact that that this may not be the case . Based on examination of the same species exist in many countries , and the overall specific content of some national legislative and policy nature of the concept are not yet clearly understood and frameworks , and comparing them to general informa - agreed upon , even by experts . tion about ï쳌¡ ï쳌¢ ï쳌³ activities within the country , it appears that legislative choices have not had a particular impact Assumptions about Contract Law on the countryâ??s success in attracting ï쳌¡ ï쳌¢ ï쳌³ arrangements ( E ï쳌« ï쳌¨ ï쳌¡ ï쳌³ ï쳌³ ï쳌¡ ï?? ï?? ï?? ï?? , C ï쳌¨ ï쳌© ï쳌³ ï쳌¨ ï쳌¡ ï쳌« ï쳌· ï쳌¥ andY ï쳌¯ ï쳌µ ï쳌® ï쳌§ ï?? ï?? ï?? ï?? , W ï쳌¹ ï쳌® ï쳌¢ ï쳌¥ ï쳌² ï쳌§ The second overarching assumption is reflected in the fre - et al . ï?? ï?? ï?? ï?? ) . Those that have attempted to streamline , or quent statement that ï쳌¡ ï쳌¢ ï쳌³ would generally be addressed by adopt specific provisions about î?© î?? î?? , for example , have not contracts and governed under national contract law ( ï쳌´ ï쳌¥ ï쳌® seen a more positive industrial reaction than others . It may K ï쳌¡ ï쳌´ ï쳌¥ and L ï쳌¡ ï쳌© ï쳌² ï쳌¤ ï?? ï?? ï?? ï?? ) . This statement is based on the be that several deeper underlying reasons explain why expectation that existing contract law could govern the the system is not fully functional , even in those countries creation , execution , implementation , and oversight of ï쳌¡ ï쳌¢ ï쳌³ which have adopted the required legal measures . These agreements , as well as address compliance or noncompli - arise out of two key legal assumptions ( about ownership ance under those agreements . and about the ability of existing contract law to address As discussed in more detail below , this statement genetic resource issues ) which were made by the negotia - also appears to have been based on some slightly flawed tors of the ï쳌£ ï쳌¢ ï쳌¤ , but which were not actually legally cor - assumptions . Primarily , it assumed that contracts can be 28 rect â?? then or now . created and implemented even when there is no legal con - cept or understanding regarding the subject matter of the Assumptions about Ownership contract . In fact , however , contracts can exist only where law and shared understanding embody a unified perception The negotiators made a primary assumption about own - of the contract , including physical subject matter , the ac - ership â?? that â?? the ownership of genetic resources will be tivities that are permitted or required ( or forbidden ) under determined under national law â?쳌 ( G ï쳌¬ ï쳌¯ ï쳌· ï쳌« ï쳌¡ ï?? ï?? ï?? ï?? ) . While the contract , and the conditions and terms that govern the providing a relatively easy solution at the time for the obligations of the individuals or entities that are bound negotiators ( enabling them completely to avoid address - by the contract . ing ownership in the Convention ) , the legal basis for this statement had not been fully analyzed at the time . In fact , Expectations about National Law as further discussed below , then and now , no clear legal concept exists under any countryâ??s national law to delin - There was a general expectation that all parties would eate what a genetic resource is , what it means to own one , adopt legislation or take other action implementing the what it means to use one , or how any of these concepts ï?? ï?? ï쳌¡ ï쳌¢ ï쳌³ - related commitments listed above.As noted above , can be applied . to date this expectation remains unfulfilled in more than Existing law relating to ownership generally focus on ï?? ï?? % of the Parties . To some extent , this lack of progress two kinds of subject matter : creates a â?? chicken - egg â?쳌 situation , in which countries are 29 â?¢ Physical tangible property ( land , plants , animals , reluctant to attempt to develop new legislation without equipment , furniture , cars , etc . ) The right to own an the positive stimulus of a successful example , while at interest in physical property derives from the right the same time no national law is able to operate a system to dispose of it â?? originally seated in one person or focused on international trade in genetic resources , when entity ; and the other countries involved have not adopted coordinat - ing frameworks . â?¢ Intangible property ( intellectual property , financial The Parties to the ï쳌£ ï쳌¢ ï쳌¤ have always very strongly em - rights , licenses of the use of trademarks , processes , phasized that â?? implementation of the Convention will be etc . ) . The one quality that these various kinds of 30 through national law â?쳌 . In most instances , this focus has intellectual property share is that they are created not significantly impeded implementation , because the by a single individual or entity ( they are human - cre - concepts addressed ( in - situ and ex - situ conservation and ated ideas , processes , designs , etc . ) . Rights to own sustainable use of natural resources ) already existed , were such property derive from that original creation . clearly subject to national sovereignty , and were governed Intellectual property that has been independently or collaboratively created by a variety of people under national law . The ï쳌£ ï쳌¢ ï쳌¤ â?? s provisions were designed to ï?? ï?? ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? ï?? : L ï쳌¥ ï쳌§ ï쳌¡ ï쳌¬ I ï쳌³ ï쳌³ ï쳌µ ï쳌¥ ï쳌³ ï쳌¡ ï쳌® ï쳌¤ ï쳌´ ï쳌¨ ï쳌¥ I ï쳌® ï쳌´ ï쳌¥ ï쳌² ï쳌® ï쳌¡ ï쳌´ ï쳌© ï쳌¯ ï쳌® ï쳌¡ ï쳌¬ R ï쳌¥ ï쳌§ ï쳌© ï쳌­ ï쳌¥ enable this global net of national controls and programs must be rigorously overseen by both the law of the source to function efficiently together â?? to achieve economies of country and the law of the user country . To date , however , scale through international cooperation and collaborative fewer than ï?? ï?? % of the ï쳌£ ï쳌¢ ï쳌¤ Parties have adopted legislation development of programs of work . addressing their primary ï쳌¡ ï쳌¢ ï쳌³ obligations , and these are all In other contexts , however , the national implementation developing countries that generally perceive themselves to approach is less efficacious . Some of these issues include be source countries ( potential beneficiaries ) . During the the problems of invasive species ( frequently caused by negotiation of the Bonn Guidelines , for example , some of importation and other activities of global trade and transit ) , the most controversial discussion centered around the fact migratory species ( which frequently cross international that the draft guidelines attempted to govern / guide the ac - 31 boundaries ) , and particularly ï쳌¡ ï쳌¢ ï쳌³ . tions of â?? source countries â?쳌 and â?? users â?쳌 . It was noted that The ï쳌¡ ï쳌¢ ï쳌³ - related provisions of the ï쳌£ ï쳌¢ ï쳌¤ are rather spe - developed country negotiators intended the latter term to cifically directed at transboundary agreements â?? i.e . , situ - refer only to corporations or other entities directly acquir - ations in which a user from one country seeks access to ing the assets , rather than the countries that are Party to 33 genetic resources from another country . Domestic access the Convention . to and use of genetic resources is not regulated , nor are The current call to reconsider the international regime the domestic issues regarding how benefits are distrib - on ï쳌¡ ï쳌¢ ï쳌³ seems to arise out of the lack of progress to date , uted , once the user has complied with the requirement to as well as the lack of clarity on some terms and mutual 32 share them with the source country . Despite this purely understandings which would , if present , enable that prog - international scope , however , the ï쳌£ ï쳌¢ ï쳌¤ assumes that its ï쳌¡ ï쳌¢ ï쳌³ ress . These issues can generally be thought of in three requirements ( like all other parts of the ï쳌£ ï쳌¢ ï쳌¤ ) will be satis - categories : fied through the development of national laws , policies , â?¢ Concepts that require clarification ; and institutions . â?¢ Assumptions that need to be reconsidered ; and In combination , the transnational nature of ï쳌¡ ï쳌¢ ï쳌³ trans - â?¢ Critical issues and areas that have not yet been actions and the preference for national implementation strongly suggests that governance of these transactions addressed . Concepts Insufficiently Clarified The ï쳌£ ï쳌¢ ï쳌¤ â?? s provisions of ï쳌¡ ï쳌¢ ï쳌³ do not address a number of erned and enforced consistently across borders . At pres - issues that are needed to form the basis of an integrated ent , although ï쳌¡ ï쳌¢ ï쳌³ agreements are negotiated under the law or collaborative international regime . In general , a policy of the source country , there is often no basis for source instrument such as the ï쳌£ ï쳌¢ ï쳌¤ is seen as setting out the over - country enforcement in cases of later violation . Typically , arching objective . National and subnational governments by the time any violation of the source countryâ??s ï쳌¡ ï쳌¢ ï쳌³ law then develop legislation whose task is to find or create a is known , the user may be completely removed from the concrete method of achieving all or part of those objectives . source country . Unless the violator or some valuable as - This is the primary task of legislation â?? to look at both the sets of the violator remain in the source country , the only objectives that the policy makers seek to achieve , and the way to compel the userâ??s compliance will be to take action available tools , and , on the basis of this analysis , to deter - in another country â?? one in which user is present or has mine what action is possible and adopt a concrete system assets . This is true even if the contract specifies that it is for requiring , facilitating , or controlling that action . â?? governed under the law of the source country â?쳌 . In the years immediately following the ï쳌£ ï쳌¢ ï쳌¤ â?? s entry into It may be ( financially or otherwise ) difficult or impos - force , it was hoped that national implementing legislation sible for the source country to obtain access to the courts in would take on this task , clarifying these points . If many a developed country . Even if a legal action is undertaken , countries did this , there would eventually be one or more the contract will be interpreted by a judge or arbitrator in recognized approaches which could be unified into a gen - a country of the user , who cannot be a good judge of the erally international understanding , which in turn might intentions and practices of the source country . Without then be reflected in a document like the Bonn Guidelines . international consistency , based on clearly agreed inter - Unfortunately , however , national legislation to date has national concepts , another countryâ??s courts will probably almost uniformly adopted the policy - style language of the interpret the source countryâ??s contracts quite differently ï쳌£ ï쳌¢ ï쳌¤ , rather than adopting practical systems for applying from what the source country expects . that language ( C ï쳌¡ ï쳌¢ ï쳌² ï쳌¥ ï쳌² ï쳌¡ ï?? ï?? ï?? ï?? ) . This means that a number Concerns about clarity seem to be one of the primary of large gaps and inconsistencies still exist that the regime drivers motivating detailed processes and complex institu - discussions will have to address . tions in national and regional ï쳌¡ ï쳌¢ ï쳌³ legislation . Governments , when entering into transactions for the use of patrimonial Law and Consistency property or assets subject to sovereign control , are bound by high standards and duties to protect the interests of the A critical basis for the call for clarification is the fact that the international system must , necessarily , be legally gov - people . Individual officials who breach this responsibility ï?? ï?? ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ of care may be subject to large fines and other penalties , Distinguishing Between Countries of Origin and and may lose their careers due to a lack of trust . It is no Source Countries wonder , then , that they insist on a high level of procedural The ï쳌£ ï쳌¢ ï쳌¤ identifies two categories of countries providing protection , detailed contracts , and other complex require - access and receiving a share of benefits , based on their ments , when they are undertaking such transactions as to relationships to the genetic resources that they provide . kinds of property and use rights that are not clearly under - The â?? country of origin â?쳌 of a species is defined as the stood . The call from industry to simplify legislation and country which possesses in it conditions where genetic procedures may have the impact of diminishing protection resources exist within ecosystems and natural habitats , and , of national patrimony , increasing the risk of inappropriate in the case of domesticated or cultivated species , in the or even corrupt transactions , or , in the alternative , increas - surroundings where they have developed their distinctive 35 ing possible exposure of officials to claims that they have properties . Rather clearly , where a species , subspecies , 36 violated their fiduciary obligations . or variety is widely distributed , it may have more than one country - of - origin . This is also true for species which Explanatory Guidance on Terms and migrate across national boundaries and for traditional varieties that have been historically and prehistorically Concepts developed , traded , and carried over large areas . Although One of the most frequently recognized needs relating to the ï쳌£ ï쳌¢ ï쳌¤ notes that countries - of - origin â?? should â?쳌 receive ï쳌¡ ï쳌¢ ï쳌³ is the need for clear , shared understanding of key terms 37 certain types of voluntary capacity - building , none of the and concepts . This primarily definitional process , however , ï쳌£ ï쳌¢ ï쳌¤ â?? s mandatory commitments relating to benefit sharing is integrally connected to the conceptual development pro - are directed at countries - of - origin . cess.Agreement about the outcomes and mandates that will By contrast , the â?? country providing genetic resources â?쳌 be embodied in the international ï쳌¡ ï쳌¢ ï쳌³ regime must develop ( generally referred to as source country ) refers to the first , and definitions be concretized based on the substance country supplying the particular specimens of genetic re - of this agreement , as a means of rendering it clearly . In 38 sources in a particular transaction . With the development a number of instances , potentially useful concepts have and proliferation of botanical gardens , zoos , herbaria , and been sketched by the ï쳌£ ï쳌¢ ï쳌¤ , and seem to need only to be more generalized international trade and transportation more concretely clarified . The following discussion briefly of plants and animals over the past century - and - a - half , identifies several such concepts . many species ( even those of highly localized origin ) may have dozens of potential source countries . However , the Access and Benefit Sharing as Distinct Concepts ï쳌¡ ï쳌¢ ï쳌³ obligations in the ï쳌£ ï쳌¢ ï쳌¤ are specifically directed at one In general , the ï쳌£ ï쳌¢ ï쳌¤ seems to draw a distinction between source country ( the one in which samples are collected ) , access ( the processes of obtaining samples , generally in - rather than any country - of - origin . cluding screening ) and benefit sharing ( the later sharing of Hence , the source - country definition , and its relation to profits and other benefits that the user of those resources the equity concept that is the raison dâ??être of ï쳌¡ ï쳌¢ ï쳌³ imple - obtains through their commercialization ) . This issue was discussed in the mid - ï?? ï?? ï?? ï?? s , in the context of the revi - mentation , poses one of the most difficult challenges in the sion of the International Undertaking on Plant Genetic ï쳌£ ï쳌¢ ï쳌¤ . In ï?? ï?? ï?? years of international species movement , there Resources ( now superseded by the ï쳌© ï쳌´ ï쳌° ï쳌§ ï쳌² ï쳌¦ ï쳌¡ ) . Looking at has been little or no tracking . Even today , most botanical the question of access to and use of genetic resources for gardens do not keep records of transactions by which third food and agriculture , this concept was noted repeatedly : parties obtain samples from their collections , and down - 34 â?? â?? free access â?? does not mean â?? free of charge â?? â?쳌 . stream sharing by private users of specimens is almost This point was particularly relevant in this context , completely untracked . Scientifically , it is increasingly because the ï쳌© ï쳌´ ï쳌° ï쳌§ ï쳌² ï쳌¦ ï쳌¡ does not necessarily contemplate any possible ( provided funding and equipment are available ) direct payment of benefits . ï쳌© ï쳌´ ï쳌° ï쳌§ ï쳌² ï쳌¦ ï쳌¡ sets up a multilateral to identify the species of an extracted ï쳌¤ ï쳌® ï쳌¡ sample from system to facilitate exchanges of germplasm from a large genetic analysis of that sample ( without direct observa - list of important food and forage species . In essence , the tion of any part of the physical specimen . ) However , it parties agree that they receive a benefit from mutual shar - remains virtually impossible to credibly determine the ing of â?? plant genetic resources for food and agriculture â?쳌 , source location from which a particular specimen or its for purposes of plant variety development and improve - genetic material was collected . ment â?? an activity that virtually all developing countries The Concept of Potential Value are directly undertaking . This sharing of resources is As discussed below , the definition of genetic resources agreed to be â?? benefit sharing â?쳌 for ï쳌¡ ï쳌¢ ï쳌³ purposes , without in the ï쳌£ ï쳌¢ ï쳌¤ is tied to the whether the resource has â?? actual the need for specific ï쳌¡ ï쳌¢ ï쳌³ contracts . However , this is a col - or potential value â?쳌 . At present , it is not clear whether the lective benefit , but the burden of providing access ( letting quoted language would exclude any species â?? or specimenâ??s strangers collect samples on their land ) may fall on a single genetic resources from the coverage of the ï쳌£ ï쳌¢ ï쳌¤ . ( In the farmer or community . This person or community must world of genes , it is not yet clear whether there are some be compensated for access in addition to sharing in the collective benefit . species whose genes are more valuable and useful than ï?? ï?? ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? ï?? : L ï쳌¥ ï쳌§ ï쳌¡ ï쳌¬ I ï쳌³ ï쳌³ ï쳌µ ï쳌¥ ï쳌³ ï쳌¡ ï쳌® ï쳌¤ ï쳌´ ï쳌¨ ï쳌¥ I ï쳌® ï쳌´ ï쳌¥ ï쳌² ï쳌® ï쳌¡ ï쳌´ ï쳌© ï쳌¯ ï쳌® ï쳌¡ ï쳌¬ R ï쳌¥ ï쳌§ ï쳌© ï쳌­ ï쳌¥ others . ) Recently , significant work in the field has been The Relationship of ABS to Other focused on microbial biodiversity ( often found in brack - International Legal Frameworks ish waters ) , and various weed species that were formerly thought to be valueless . A third area in which further clarification may be needed is the manner in which the ï쳌¡ ï쳌¢ ï쳌³ system interacts with The Basis for the Term Equitable other legal systems and frameworks , both domestic and In general , ï쳌¡ ï쳌¢ ï쳌³ is perceived to be the â?? third pillar â?? of the international . Here also , although the ï쳌£ ï쳌¢ ï쳌¤ includes some ï쳌£ ï쳌¢ ï쳌¤ and the only direct statement of the commitment to important provisions on this issue , many open issues equity within the ï쳌£ ï쳌¢ ï쳌¤ . The legal meaning of the term remain . It is not possible to incorporate the discussion equity , however , has not been well explained . Equity is of this issue into this paper , in part due to limitations in a legal concept that embodies many kinds of fairness . time and length , but more particularly because the full For purposes of developing the international regime , it range of legal analysis into these issues is still ongoing . is important to understand many aspects of equity , but One example may be useful to illustrate this issue â?? ma - especially those that are expressly applied to ï쳌¡ ï쳌¢ ï쳌³ in the rine biodiversity . The ï쳌£ ï쳌¢ ï쳌¤ addresses the conservation of terms of the ï쳌£ ï쳌¢ ï쳌¤ . oceans beyond the coastal and exclusive economic zones At its most basic , the ï쳌£ ï쳌¢ ï쳌¤ requires Parties to ensure through four primary provisions . First , the Parties specifi - that conservation and sustainable use is also equitable . The cally take on â?? the responsibility to ensure that activities ï쳌£ ï쳌¢ ï쳌¤ , however , does not simply impose a general duty of within their jurisdiction or control do not cause damage equity â?? presumably because this duty that already exists to the environment of other States or of areas beyond in both national and international law . Rather , in the ï쳌¡ ï쳌¢ ï쳌³ 41 the limits of national jurisdiction â?쳌 . This undertaking provisions , it identifies a particular area of equity - related is enhanced by jurisdictional provisions noting that â?? the concern and obligation â?? the use of genetic resources . This provisions of this Convention apply â?¦ within the area of focus on genetic resources arose because there was a lack its national jurisdiction or beyond the limits of national of general legal principles addressing these resources . 42 jurisdiction â?쳌 . Most important , the parties are to engage Throughout distant and recent history , where there is a in appropriate cooperation â?? directly or , where appropriate , legal vacuum and limited capacity on an issue relating to through competent international organizations , in respect the exploitation of resources , many ( especially developing ) of areas beyond national jurisdiction â?¦ , for the conserva - countries have been legally and equitably disadvantaged 43 tion and sustainable use of biological diversity â?쳌 . Finally , when other countries obtained and used those resources . In the parties are specifically mandated to â?? implement the the ï?? ï?? ï?? ï?? s and ï?? ï?? ï?? ï?? s , as information became known about ï쳌£ ï쳌¢ ï쳌¤ with respect to the marine environment consistently many new and very profitable uses of genetic resources , with the rights and obligations of States under the law of there was a fear that a similar pattern of inequitable ex - the sea â?쳌 . ploitation was developing ( G ï쳌¬ ï쳌¯ ï쳌· ï쳌« ï쳌¡ ï?? ï?? ï?? ï?? ) . Unfortunately , the ï?? ï?? ï?? ï?? United Nations Convention As to this type of inequity , the ï쳌£ ï쳌¢ ï쳌¤ invokes a specific 44 on the Law of the Sea ( ï쳌µ ï쳌® ï쳌£ ï쳌¬ ï쳌¯ ï쳌³ ) , which is recognized to component of the larger concept of equity sometimes be a comprehensive unified framework for international called â?? unjust enrichment â?쳌 . Equity law provides that governance of oceans was negotiated for nearly ï?? ï?? years , unjust enrichment should lead to fair compensation . In beginning well before the commencement of the ï쳌£ ï쳌¢ ï쳌¤ nego - other words , it is not fair for one person or entity to ob - tiations , being formally adopted nine years before the ï쳌£ ï쳌¢ ï쳌¤ , tain benefits through the uncompensated exploitation of but entering into force two years after the ï쳌£ ï쳌¢ ï쳌¤ . All of this 39 the resources belonging to another . The ï쳌£ ï쳌¢ ï쳌¤ makes this occurred , at a time when a ) the legal concept of â?? genetic clear â?? stating the obligation of â?? equitable sharing of the resources â?? as some type of ownable property right did not benefits arising out of the utilization of genetic resources â?쳌 . yet exist ; b ) it was generally assumed that there was little The term â?? benefits â?¦ of utilization â?쳌 is a clear reference or no life in the oceans below ï?? ï?? ï?? m depth ; and c ) it was to the benefits received by the users . This seems to be believed that marine mammals were the primary targets separate from the ï쳌£ ï쳌¢ ï쳌¤ â?? s more general equity provisions , of high - seas conservation , because pelagic fish and other where it calls upon the parties to endeavor to work in the commercially harvested high - seas species were thought country of origin of the genetic resources , and undertake to be so plentiful that even drastically increased harvest 40 other actions that benefit local people , for example . Such levels would still be sustainable . benefits seem to be in addition to , and not a substitute Since that time , however , many kinds of marine species for , a â?? share of the benefits arising from utilization â?쳌 â?? i.e . of remarkable scientific value and other potential have been profits , intellectual property rights , and other value . Other found on the deep seabed , well below ï?? ï?? ï?? m , and in fish parts of the convention suggest that countries have broader and other marine organisms in the water column beyond equitable obligations , however the obligation of equitable national jurisdiction ( B ï?¹ ï쳌¡ ï쳌º ï쳌« ï쳌© ï쳌¥ ï쳌· ï쳌© ï쳌£ ï쳌º ï?? ï?? ï?? ï?? , P ï쳌¡ ï쳌´ ï쳌´ ï쳌¯ ï쳌® ï?? ï?? ï?? ï?? ) . benefit sharing is specifically the obligation of the user to The sustainability of commercially harvested pelagic fish share the benefits that it receives . species is being called into serious question . ï쳌µ ï쳌® ï쳌£ ï쳌¬ ï쳌¯ ï쳌³ is unclear about whether and how it governs ï쳌¡ ï쳌¢ ï쳌³ issues and the rights to marine genetic resources ( ï쳌£ ï쳌¢ ï쳌¤ Secretariat and ï?? ï?? ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ ï쳌µ ï쳌® ï쳌¤ ï쳌¯ ï쳌¡ ï쳌¬ ï쳌¯ ï쳌³ ï?? ï?? ï?? ï?? ) . Within the worldâ??s oceans there are A recurring theme that arose in nearly every aspect of the first year of the ï쳌© ï쳌µ ï쳌£ ï쳌® ï쳌¡ ï쳌¢ ï쳌³ Project has been the need to both areas within national jurisdiction and control ( territo - address these issues in a synergistic way , particularly at the rial seas , exclusive economic zones , continental shelves , national level . There is a well - recognized value in expand - etc . ) and so - called international waters that are outside ing the issue of consistency beyond the confines of ï쳌¡ ï쳌¢ ï쳌³ , to of any countryâ??s jurisdiction . However , it does contain a include all legal issues relating to genetic resources â?? in mechanism ( the International SeabedAuthority ) and other essence , to consider the need for an integrated framework mandates which may be useful for international sharing that encompasses not only ï쳌¡ ï쳌¢ ï쳌³ , but also biosafety , genetic of the benefits from genetic resources of the seabed . It is resources for food and agriculture , and genetics - based possible that this mechanism may not only be used for research . To a large extent , the separation among these sharing the benefits from seabed genetic resources , but may issues is artificial . The separation was originally designed also be a useful example of how benefits may be shared to simplify the ï쳌£ ï쳌¢ ï쳌¤ negotiations . However , there is no clear nationally and internationally . Similar issues may apply reason for maintaining these distinctions permanently , if in integrating ï쳌¡ ï쳌¢ ï쳌³ with frameworks relating to Antarctica , the merger of the issues will be of assistance . international trade , migratory species , intellectual property , Certainly the linkage between the issues should be and others . more clearly recognized legally . For example , the primary subject of the Cartagena Protocol is ï쳌§ ï쳌­ ï쳌¯ s . All ( or at least Relationship of ABS to Other Obligations a significant number ) of ï쳌§ ï쳌­ ï쳌¯ s are products of the use of of the Parties â?? genetic resources â?쳌 as defined in the ï쳌£ ï쳌¢ ï쳌¤ â?? i.e . , they have ï쳌¡ ï쳌¢ ï쳌³ issues , although firmly entrenched concepts in inter - been developed utilizing at least some of this genetic mate - national law , are only one part of a much broader set of rial . In essence , where the ï쳌¡ ï쳌¢ ï쳌³ discussion focuses on the issues â?? genetic resources . These issues are addressed by needs and desires of source - countries / countries - of - origin a number of international instruments , which create or ( to be compensated as providers of genetic resources ) , address specific obligations of their Parties , including espe - the Cartagena Protocol focuses on the needs and desires cially the Cartagena Protocol on Biosafety in conjunction of the users ( to be able to introduce and market ï쳌§ ï쳌­ ï쳌¯ s with the ï쳌£ ï쳌¢ ï쳌¤ â?? s other provisions on biosafety issues ( issues around the world ) . relating to genetically modified organisms ) , the ï쳌© ï쳌´ ï쳌° ï쳌§ ï쳌² ï쳌¦ ï쳌¡ As further discussed below , it may be appropriate ( issues related to the sharing of agricultural varieties of to consider reuniting these issues at the national level , important crops for food security ) , and the ï쳌· ï쳌© ï쳌° ï쳌¯ instru - through the development of a single National Framework ments and the Agreement on Trade - Related Aspects of on Genetic Resources and their Use . This approach would Intellectual Property Rights ( ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ ) ( issues related to the enable a unified compliance with this range of international creation of intellectual property rights in innovations using agreements , and avoid inconsistency , overlap , or unregu - genetic resources . ) All of these instruments and others are lated gaps in the system.A unified approach to implement - very similar to ï쳌¡ ï쳌¢ ï쳌³ in the sense that they address outcomes ing these issues might be of real assistance . Perhaps more in many of the same fields of endeavor , seek to promote important , as discussed below , this re - linkage might tie two a similar type of systematic development , and involve at market components together in a way that enables better least some aspects of genetic resources . development of incentives and other financial tools . Assumptions Insufficiently Considered The negotiators of the ï쳌£ ï쳌¢ ï쳌¤ made a number of assumptions appears that they can only be addressed collectively . about legal issues and how genetic resources issues will operate . These assumptions underlie a significant part of Genetic Resources As Property under the current conception of ï쳌¡ ï쳌¢ ï쳌³ at the international political National Contract Law level . They have not generally been borne out in practice . In the years of the negotiations ( the ï?? ï?? ï?? ï?? s ) , there was only As such , they are probably the most immediate ( and dif - a very rudimentary understanding of genetic research , even ficult ) hurdles that must be surmounted in the regime among biologists and specialists in scientific research and negotiations . development ( the primary technical advisors to the nego - This paper will briefly examine three of the primary 45 tiators of the ï쳌£ ï쳌¢ ï쳌¤ ) . As a consequence , there were strong assumptions that were promulgated during the negotiations concerns during the negotiations regarding coverage . It of the ï쳌£ ï쳌¢ ï쳌¤ and explain how they prevent , impact , or restrict was feared that definitions and primary provisions relating the implementation of ï쳌¡ ï쳌¢ ï쳌³ concepts â?? a ) the nature of ge - to genetic resources would be either : netic resources , b ) reliance on existing national contract law to provide the framework for ï쳌¡ ï쳌¢ ï쳌³ , and c ) valuation of â?¢ Too restrictive ( which might mean that some users genetic resources.Although these are discussed as separate would still be able to benefit inequitably from the issues , they are interconnected to such an extent that it use of omitted types of resources ) or ï?? ï?? ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? ï?? : L ï쳌¥ ï쳌§ ï쳌¡ ï쳌¬ I ï쳌³ ï쳌³ ï쳌µ ï쳌¥ ï쳌³ ï쳌¡ ï쳌® ï쳌¤ ï쳌´ ï쳌¨ ï쳌¥ I ï쳌® ï쳌´ ï쳌¥ ï쳌² ï쳌® ï쳌¡ ï쳌´ ï쳌© ï쳌¯ ï쳌® ï쳌¡ ï쳌¬ R ï쳌¥ ï쳌§ ï쳌© ï쳌­ ï쳌¥ However , the very fact that there are separate defini - â?¢ Too broad ( which might mean that the system tions of the two , and that the ï쳌£ ï쳌¢ ï쳌¤ uses them in very dif - would apply to uses that are already operating in a ferent contexts , suggests that the negotiators intended the fair and equitable manner ) . meaning of genetic resources to be different from that of In the end , the negotiation of the ï쳌£ ï쳌¢ ï쳌¤ appears to have biological resources . Lacking a clear definition , good legal sidestepped the primary coverage questions relating to practice suggests that the difference must be determined ï쳌¡ ï쳌¢ ï쳌³ â?? i.e . , decided not to answer the questions â?? What are by examining the usage of the terms within the ï쳌£ ï쳌¢ ï쳌¤ and â?? genetic resources â?? and how are they ( legally ) different 49 in subsequent decisions and practices . In general , the from â?? biological resources â?? ? â?쳌 Clearly , however , the reso - ï쳌£ ï쳌¢ ï쳌¤ â?? s provisions discussing genetic resources are entirely lution of these issues will color the nature and content of directed to the use of those resources . They seem especially the entire regime negotiations . focused on transactions that do not involve bulk purchase The failure to address this definitional problem left the of organic matter as for normal bulk uses . The assumption field open to the multitude of commentators who promoted seems to be that a genetic resource can be synthesized or the assumption that genetic resources were simply a new propagated based on a single sample , so that there is little type of property that is similar ( under the law ) to all other long - term need for additional samples . types of property â?? that national legal frameworks govern - Even the access requirement ( Article ï?? ï?? . ï?? ) focuses ing ownership of property and commercial transactions on use . It speaks directly to the need to â?? facilitate access would also directly govern ï쳌¡ ï쳌¢ ï쳌³ - related activities ( in the to genetic resources for environmentally sound uses â?¦ â?쳌 . same way that the first inventors and marketers of radios Nearly all of the other ï쳌¡ ï쳌¢ ï쳌³ provisions described above ad - were able to use the markets and rules applicable to fur - dress either the use of the genetic resources , information 46 niture , to market their inventions ) . The basic problem developed or discerned from accessing them , or various regarding the nature of genetic resources is exemplified 50 particular benefits from those uses . Taken together with by the relevant definitions within the ï쳌£ ï쳌¢ ï쳌¤ ( â?? biological the literature of the period in which these issues were resources â?쳌 , â?? genetic material â?쳌 , and â?? genetic resources â?쳌 ) being negotiated ( late ï?? ï?? ï?? ï?? s ) , it appears that the general as well as by two concepts that are completely omitted assumption was that the ï쳌¤ ï쳌® ï쳌¡ pattern of each species , ( or from the ï쳌£ ï쳌¢ ï쳌¤ â?? the use of genetic resources and their more particularly , each subspecies or variety ) was the 47 ownership . resource . It may also have been assumed that ï쳌¤ ï쳌® ï쳌¡ was a separate physical substance that could be separately con - Recognizing / Defining Genetic Resources trolled . But it was generally recognized as an informational The most important single concept relating to ï쳌¡ ï쳌¢ ï쳌³ is prob - resource â?? one that could be synthesized or used in the ably the definitional or conceptual understanding of what process of synthesizing so - called artificial ï쳌¤ ï쳌® ï쳌¡ or creating a genetic resource actually is , and how it is distinguished ï쳌§ ï쳌­ ï쳌¯ s . At a minimum , the clear expectation was that ï쳌¡ ï쳌¢ ï쳌³ from other resources . The ï쳌£ ï쳌¢ ï쳌¤ â?? s provisions , and many would focus on the special issues surrounding the use of statements of the Parties thereafter , have made it clear functional units of heredity . that ï쳌¡ ï쳌¢ ï쳌³ and requirements apply only to genetic resources , By contrast , the provisions addressing biological so that a clear understanding of their nature is essential 48 resources are focused very directly on activities and im - to application of these provisions . Unfortunately , the pacts on species and ecosystems , and on positive measures relevant definitions in the ï쳌£ ï쳌¢ ï쳌¤ itself ( Article ï?? ) do not within each country to preserve biodiversity both in situ provide a basis for this understanding : and ex situ . It appears , then , that the distinction between â?? Genetic resources â?쳌 means genetic material of actual genetic resources and the rest of biological resources is or potential value . the manner in which they are used . Genetic material and â?? Genetic material â?쳌 means any material of plant , animal , genetic resources , as used in the ï쳌£ ï쳌¢ ï쳌¤ , refer to either : microbial , or other origin containing functional units â?¢ The genetic code or unique genetically defined char - of heredity . acteristics of species ( a type of information ) or â?? Biological resources â?쳌 includes genetic resources , â?¢ The use of samples : i.e . , particular analysis and organisms , or parts thereof , populations , or any other utilization of their ï쳌¤ ï쳌® ï쳌¡ , genes , and other genetic biotic component of ecosystems with actual or potential components ( a right of use ) . use or value for humanity . A genetic resource would thus be , not a type of mate - On their face , it is difficult to see a distinction among rial , but an intangible property â?? a type of information or these definitions . It is generally assumed that the phrase use . The buyer of a blue flower buys the biological resource â?? functional units of heredity â?? refers to ï쳌¤ ï쳌® ï쳌¡ and ï쳌² ï쳌® ï쳌¡ . when he intends to use the flower as a decoration on his Currently , ï쳌¤ ï쳌® ï쳌¡ and ï쳌² ï쳌® ï쳌¡ are thought to be the biologi - table . He buys a genetic resource if he intends to use the cal components that determine the nature and heritable ï쳌¤ ï쳌® ï쳌¡ to create a new strain of blue carrot . For the latter properties of every life form â?? and to be present in every activity , he would need an ï쳌¡ ï쳌¢ ï쳌³ arrangement or license . cell of all organic ( and no nonorganic ) matter . Hence , all This kind of distinction between biological resources and biological resources ( including â?? parts thereof â?쳌 ) contain functional units of heredity . genetic resources seems clearly to be what the Convention ï?? ï?? ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ envisions , but it needs to be stated in legislation and other with it the right to ordinary methods of propagation or instruments , so that it can be applied in implementation breeding of that plant or animal , or at a minimum , some and enforcement of the ï쳌¡ ï쳌¢ ï쳌³ process . clear rules regarding any limitations on that right . One of At the same time , the above clarification is at the the main factors in determining the value of a horse or cow , heart of many difficulties encountered in attempting to for example , is by whether it is capable of reproduction . implement ï쳌¡ ï쳌¢ ï쳌³ obligations and objectives . The same ma - Similarly , the rights to bulk cultivation and / or collection terial , specimen or sample would be treated differently and sale of wild and domesticated plants ( and animals ) in the ï쳌¡ ï쳌¢ ï쳌³ system , depending on how it will be used . ï쳌¡ ï쳌¢ ï쳌³ is a well - accepted component of the ownership of seeds 52 measures and controls in provider - based contractual ï쳌¡ ï쳌¢ ï쳌³ and seed sources . An ï쳌¡ ï쳌¢ ï쳌³ regime that casts its nets too arrangements would be legally effective , then , only where widely may include these traditional uses â?? thus creating the governments and providers have the ability to know , either a disruption of existing markets or an inconsistency oversee , and control the uses that are made of the resources . in the ï쳌¡ ï쳌¢ ï쳌³ system . However , in the case of ï쳌¡ ï쳌¢ ï쳌³ , the provider governmentâ??s The international regime , as well as national legisla - involvement occurs at the â?? front end â?? â?? the ï쳌¡ ï쳌¢ ï쳌³ process tion , must clarify what activities constitute utilization of requires negotiation of contracts and other actions before genetic resources for which access and benefit - sharing ar - any use has been made . By the time the resource is used , rangements will be required . One of the critical challenges the samples are usually outside of the jurisdiction of the will be to define this concept in a way that is broad enough agencies that conducted the negotiation and signed the to enable oversight of new or special uses and ensure that contracts . Most source countries cannot know how the middlemen and agents cannot circumvent ï쳌¡ ï쳌¢ ï쳌³ require - resource is being used , and cannot enforce permits and con - ments , while ensuring that the legislation does not create tracts against a bioprospector who violates his restrictions difficulties of enforcement application . In this connection , or commitments after he has left the source country . it seems important to ensure that the ordinary sale of bulk goods is not included.A farmerâ??s sale of his crop of cotton , Use of Genetic Resources maize , bananas , etc . should not be subject to restrictions A second question that is rather clearly still not understood under benefit - sharing concepts.At the same time , it should is what it means to use genetic resources . During the ne - be clear that a purchase of beans from a farmerâ??s market gotiations of the ï쳌£ ï쳌¢ ï쳌¤ , overwhelming attention focused on does not confer on the purchaser a right to commercially genetic laboratory processes â?? the sampling of species and utilize the genetic material from those beans without com - direct commercial use of their ï쳌¤ ï쳌® ï쳌¡ for the laboratory - based plying with ï쳌¡ ï쳌¢ ï쳌³ requirements . creation of new biochemical compounds , ï쳌§ ï쳌­ ï쳌¯ s , and the artificial propagation or synthesis of substances having Practical Implementation : Owning and Tracking 51 biochemical properties . It was sometimes difficult for Genetic Resources agricultural organizations to ensure that the negotiators As a practical matter , ownership and resource tracking remembered other kinds of variety development that might issues are probably the greatest hindrances to progress also be a part of the ï쳌¡ ï쳌¢ ï쳌³ concept . This leads , however , to an on ï쳌¡ ï쳌¢ ï쳌³ . interesting question . Exactly what activities are considered Owning Genetic Resources . Virtually any definition of to be use of genetic resources ? If we think of this as utiliza - genetic resources and the use of genetic resources will still tion of a species â?? â?? functional units of heredity â?? , then : be incomplete without a unification of the issue of owner - â?¢ The most common use of any species â?? functional ship of those resources . The difficulties in this respect arise units of heredity is by ordinary reproduction of out of three sources : that species â?? including by planting seeds that have â?¢ Genetic resources are often not country specific . If been purchased or saved or breeding animals held the same species , subspecies , or variety is present in captivity . This is the basis for claims of inclusion in two countries , then under the ï쳌£ ï쳌¢ ï쳌¤ , both countries of conventional plant breeding ( hybridization and have sovereign rights to its genetic resources ( that selection ) as uses of genetic resources . is either genetic information or the right to make â?¢ The theory of genetics that is generally based on the use of that information ) . The genetic resource is ï쳌¤ ï쳌® ï쳌¡ discoveries made by Watson - Crick and others the same for both of them . holds that a species â?? biochemical properties are de - â?¢ Negotiation of ï쳌¡ ï쳌¢ ï쳌³ arrangements occurs between termined by its ï쳌¤ ï쳌® ï쳌¡ . On this basis , some commen - the user and the specific country in which the tators have suggested that bulk use of biological species samples are collected ( which will provide resources ( as ingredients in commercial products , the genetic material to be studied and utilized . ) It herbal medicines , components in other medicinal does not even involve notice to other countries of products , cosmetics , spices , tea , etc . ) constitutes a origin . When the benefit - sharing element of the ar - utilization of genetic resources . rangement comes into play , the benefits are shared only with the source country ( or in some cases , only In virtually all countries , however , the ownership of or other legal dominion over a plant or animal usually carries with the particular community or property owner ï?? ï?? ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? ï?? : L ï쳌¥ ï쳌§ ï쳌¡ ï쳌¬ I ï쳌³ ï쳌³ ï쳌µ ï쳌¥ ï쳌³ ï쳌¡ ï쳌® ï쳌¤ ï쳌´ ï쳌¨ ï쳌¥ I ï쳌® ï쳌´ ï쳌¥ ï쳌² ï쳌® ï쳌¡ ï쳌´ ï쳌© ï쳌¯ ï쳌® ï쳌¡ ï쳌¬ R ï쳌¥ ï쳌§ ï쳌© ï쳌­ ï쳌¥ from which the specimens were taken ) . Tracking Genetic Resources . Two other practical ele - ments that must be addressed in this connection are â?¢ However , if the user applies for the relevant intel - downstream transactions and the concept of a research lectual property right or other legal protection for exception . A number of institutions ( particularly botanical innovations based on or using this genetic material , gardens , universities , and other research organizations ) he will obtain a patent or other right that is valid have strongly asserted that exceptions should be gener - against all the world . ally created under which they can gain access to genetic Although obtaining the rights from and providing resources more easily , and not be bound by stringent con - benefits to only one person or community or country , the trols on subsequent sharing of the genetic resources and userâ??s ï쳌© ï쳌° ï쳌² application can essentially prevent other coun - information concerning it . These assertions are based on tries from engaging in a similar use of the same species , the public and scientific nature of these institutions â?? their despite equal sovereignty over the species within their research is undertaken to increase knowledge and is thus borders . The genetic resource is localized for payment different from commercial research and development . ( minimizing the cost to the user ) and globalized for pro - This position strongly supports the view that genetic tection ( maximizing the protection and potential value to resources are actually rights of use . It also illustrates the user . ) The benefits to source countries and their people are related point â?? that the use of genetic resources cannot essentially caught in a squeeze . be known at the time of the transaction and can change The inherent inconsistency can be illustrated by a over time . simple story : Suppose that five people cowrite a song . They The promotion of research is a vital activity . It remains all agree that any of the five may , if he chooses , sell the true , however , that even where resources are being taken song to anyone ( multiple ownership . ) Then one of the five solely for research , their use can change in the future . As sells the exclusive rights to the song for a large sum , and a result , any simply expressed research exception will does not share his profits with the others . The buyer then probably serve as a major loophole in the international copyrights the song , based on his exclusive rights . At this regime . Already , botanical gardens have indicated that point , the buyer can claim that he is the only owner with they do not track lateral transfers of genetic resources to a continuing right to sell the song . He is protected against other gardens and collectors and do not intend to do so . A any other claim , including from the other four original system has been proposed that will seek to ensure that this co - writers . None of the others can ever sell the song again . lack of tracking does not invalidate the ï쳌¡ ï쳌¢ ï쳌³ system , but it Realistically , if the international regime is to function as a is still not adopted by internationally active associations legally consistent and rational process , it must find a way 54 of botanical gardens . to rationalize these ownership issues . On the surface this Other research institutions have even less willingness would suggest that it must either : to support a genetic material tracking system . Noting that â?¢ Recognize single ownership through the entire noncommercial researchers are the primary current mecha - process ( in which case the buyer could not patent nism by which key developing country research needs are the resource against countries that do not share in 55 addressed , they point out that even transaction and time benefits ) ; or costs that would be acceptable to commercial entities may â?¢ Consider the genetic resource to be an international be impossible within the tight budgets of noncommercial resource from the beginning ( in which case ben - research . efits from genetic resources should compensate all Mechanisms for tracking traffic in genetic resources countries which possess that resource ) . and monitoring downstream transactions seem to be es - sential to the oversight of any direct use - based system of Both of these options , although satisfying the needs for benefit sharing . Discussions of some of these mechanisms equity and consistency , would be difficult or impossible to are already underway , even though the configuration of apply in practice . However , the need for consistency is not 56 the ï쳌¡ ï쳌¢ ï쳌³ system is still not clear ( R ï쳌µ ï쳌© ï쳌º ï?? ï?? ï?? ï?? ) . Many simply a matter of aesthetics . In order for a legal regime to commentators , however , suggest that due to the difficul - operate it must not only contain clear , enforceable state - ties involved , such tracking should not even be attempted ments , but also be organized into a rational , consistent ( P ï쳌© ï쳌² ï쳌¥ ï쳌³ ï쳌¤ ï쳌¥ C ï쳌¡ ï쳌² ï쳌¶ ï쳌¡ ï쳌¬ ï쳌¨ ï쳌¯ ï?? ï?? ï?? ï?? ) . Instead , they suggest rely - framework . Without rational consistency , every time an ing on new provisions of patent law that would require issue arises that is not directly discussed in the legislation , disclosure of origin when any patent is sought for an new legislation will be required . If the system is consistent , invention that utilizes genetic material . This mechanism judges and administrators ( and enforcement officers ) will may be partially effective . It cannot be thought of as the have a basis for determining how each new question fits entire solution , however . For example , it would omit many within the overall system , and need not continually return significant types of commercial utilization of genetic re - to Parliament for guidance . Accordingly , it is critical to 57 sources , and for enforcement it would require a kind of reconsider the questions of ownership . All of the various technological oversight that is currently unavailable and aspects of access , benefit sharing , patenting ( and / or us - unlikely to be generally accessible by developing countries ing ) innovations based on genetic resources must fit into 53 58 a single unified property framework . in the near future . ï?? ï?? ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ contract . The lack of shared understanding about what National Contract Law as a Basis for ABS the contract covers would make it almost impossible for Arrangements a court to mediate or adjudicate such a dispute . If it is not The assumption that ï쳌¡ ï쳌¢ ï쳌³ issues can be addressed through clear what a genetic resource is , then it is almost certainly 59 national contract law seems valid on the surface . also not clear whether an individual or entity has a right However , the complete novelty of the legal concept of to dispose of it or indeed whether the contract disposes genetic resources as a specific type of property or property of it . If the right of the party giving access to genetic re - right actually means that there is no existing legal basis sources was challenged ( by either party or by some other through which ï쳌¡ ï쳌¢ ï쳌³ arrangements can be regulated . individual ) , a court could not confidently decide the issue At its simplest , this can be explained in terms of the if it does not know what genetic resources are . This is also most basic contract principle â?? mutual agreement ( some - true of a claim that someone using genetic resources was times called the â?? meeting of the minds â?쳌 ) . If the persons en - exceeding his rights , for example . tering into a contract do not share identical understandings about what the contract covers and requires , then it is not Valuation of Genetic Resources : Markets a contract . Thus , if ï쳌¸ promises to pay for ï쳌¹ â?? s trip to Rome , One of the most insidious continuing assumptions relat - in exchange for certain performance by ï쳌¹ , it may seem that ing to ï쳌¡ ï쳌¢ ï쳌³ is the assumption that the value of the genetic they have a contract . However , if ï쳌¸ is referring to Rome , resources can be determined by negotiation of each ï쳌¡ ï쳌¢ ï쳌³ ar - Italy and ï쳌¹ is referring to Rome , NewYork , then there has rangement on a case - by - case basis . Within this assumption been no mutual agreement . Due to lack of specificity and lurks the most serious insufficiency of the ï쳌¡ ï쳌¢ ï쳌³ system â?? the mutual understanding , the contract is invalid ( see Box 1 lack of any kind of market oversight or regulation . One for an analysis of contract components ) . of the most important and unaddressed aspects of the ï쳌¡ ï쳌¢ ï쳌³ In many cases , national law clarifies common areas issue is the fact that it seeks to create a market in a com - of contractual misunderstanding . For example , there are pletely new kind of property . While the concept of a market numerous laws governing contracts for the sale of intel - is virtually universal and dates back to very ancient times , lectual property rights . Often these provide that , if the in todayâ??s world even the simplest retail markets are subject contract is silent about an issue , then the definition or to legal oversight and controls in most countries . explanation in the law will govern the contract ; but if the Many companies and users suggest that regulation will contract clearly addressed the issue in another way , the prevent or impede the formation of ï쳌¡ ï쳌¢ ï쳌³ arrangements . In contractual provision will control . practice , however , the opposite may well be true . If a clear , The underlying need for both legal and individual consistent market system were in place and subject to understanding is clearest when considering situations in which one party fails to perform or otherwise violates the appropriate oversight and control mechanisms , parties on Box 1 . Analysis of contract components The need for supporting legislation and a body of legally with the übermeisterin ? If so , how broad or restrictive is recognized facts and issues may be illustrated by the follow - that right ? 60 ing nonsense example : A simple contract is entered into as â?¢ May Young legally alienate that right to others ? follows : â?? YOUNG grants CARRIZOSA an EXCLUSIVE â?¢ Is Carrizosa a kind of person or entity that can legally RIGHT to DO - SI - DO with the Ã?BERMEISTERIN , IN receive that right ? RETURN FOR a TOT of RATATOUILLE â?쳌 . Before this â?¢ Are there any restrictions on transactions involving rights contract can be enforced , several questions must be answered . to do - si - do with government officials or transfers of rata - First are factual questions , including : touille ? ( That is , are such transactions legal ? And , if so , â?¢ Who or what are Young and Carrizosa ? Different rules must licenses be obtained or taxes paid ? ) and standards may apply if they are individuals rather than â?¢ Is this contract equitable ? ( That is , is a tot of ratatouille if they are corporations or other entities . an appropriate level of payment ? And , if not , were the â?¢ What are â?? do - si - do â?쳌 and â?? übermeisterin â?쳌 ? It may not negotiations fair ? Is public policy satisfied or should gov - be common knowledge that do - si - do is a series of steps ernment intervene in the contract or adjust its terms ? ) in ( American ) Square Dancing , and übermeisterin is a â?¢ Can the performance of the contract be verified , monitored , German official ( a female lord mayor , sometimes called the lady mayor . ) and enforced ? â?¢ What is a â?? tot â?쳌 and what is â?? ratatouille â?쳌 ? A tot is an The answers to all of these questions can be evaluated , and obsolete liquid measure and ratatouille is a French dish â?? a their impact on the contract and its enforceability assessed , very delicious vegetable stew . only if there are clear supporting laws and understandings Thereafter , the parties or the court must consider legal applicable and relevant to the type of property , the type of questions , including : use ( activity ) , and the type of entities that are involved in â?¢ DoesYoung have a legal right to determine who may dance the contract . ï?? ï?? ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? ï?? : L ï쳌¥ ï쳌§ ï쳌¡ ï쳌¬ I ï쳌³ ï쳌³ ï쳌µ ï쳌¥ ï쳌³ ï쳌¡ ï쳌® ï쳌¤ ï쳌´ ï쳌¨ ï쳌¥ I ï쳌® ï쳌´ ï쳌¥ ï쳌² ï쳌® ï쳌¡ ï쳌´ ï쳌© ï쳌¯ ï쳌® ï쳌¡ ï쳌¬ R ï쳌¥ ï쳌§ ï쳌© ï쳌­ ï쳌¥ both sides would have greater assurance that their interests important to note that these mechanisms are not voluntary enhancements of the ï쳌¡ ï쳌¢ ï쳌³ concept , but basic necessities of would not be injured by entering into an ï쳌¡ ï쳌¢ ï쳌³ arrangement . the system . Virtually all formal retail markets , even those In fact , the Andean Pact Decision ï?? ï?? ï?? , which is perhaps dealing in tangible commodities , must be bolstered by the most complex and difficult ï쳌¡ ï쳌¢ ï쳌³ law adopted to date , a range of legal mechanisms and institutions to protect may well have become so complex in an effort to ensure consumers from illegal practices and to ensure that mar - that the parties â?? interests would be protected in this new kets are protected from informal acquisition of products and unregulated market . without compensating the seller . ï쳌¡ ï쳌¢ ï쳌³ , like all of these Until the national and international ï쳌¡ ï쳌¢ ï쳌³ systems con - markets , presents opportunities for intentional deception tain generally accepted legal underpinnings , they cannot and unintentional misunderstanding on both sides that operate in a more streamlined , flexible manner while still must be controlled . adequately protecting the parties to ï쳌¡ ï쳌¢ ï쳌³ arrangements.As a consequence , national ï쳌¡ ï쳌¢ ï쳌³ laws and contracts will have to Market Transparency : Information , Registration , and contain highly protective provisions , despite their impact Fairness on the users â?? transaction costs . The primary tools needed The lack of market information and the connected need to create markets and market confidence are oversight for some protections of the participants in ï쳌¡ ï쳌¢ ï쳌³ arrange - and transparency . Given the international / transboundary ments have greatly restricted ï쳌¡ ï쳌¢ ï쳌³ development . Without nature of many ï쳌¡ ï쳌¢ ï쳌³ transactions , it appears that these tools this information , government officials in provider countries must operate or coordinate at the international level . This cannot be certain that they are properly protecting and basic point can be illustrated very simply by comparing representing national interests and the interests of persons the amount and nature of existing instruments and com - and entities under their jurisdiction . Nearly all government mitments on ï쳌¡ ï쳌¢ ï쳌³ at the international level with the similar officials are charged with a fiduciary duty when entering information regarding another new international market into contracts relating to national or patrimonial assets in development â?? the trade in carbon credits under the or otherwise acting on behalf of the state or its citizens . ï쳌µ ï쳌® Framework Convention on Climate Change ( ï쳌¦ ï쳌£ ï쳌£ ï쳌£ ) Governments typically adopt detailed procurement and ( O ï쳌² ï쳌¬ ï쳌¡ ï쳌® ï쳌¤ ï쳌¯ et al . ï?? ï?? ï?? ï?? ) . contracting policies and laws that call on officials to docu - The ï쳌¦ ï쳌£ ï쳌£ ï쳌£ , adopted at the same time as the ï쳌£ ï쳌¢ ï쳌¤ , has ment that they have received proper compensation in such regulated and negotiated at great length endeavoring to transactions . define these credits and to set up a consistent enforceable A government official who does not have credible leakproof system by which they can be created , marketed , market information telling him that the price and terms traded , and regulated . This has been a long and difficult being offered are fair and reasonable will be open to the process , even though there exists an example that is used claim that he has failed to meet that obligation . The lack of at the national level . ( For purposes of implementation there transparent market information may mean that he cannot is a strong similarity between carbon credits and various easily satisfy these requirements and would be unprotected against later claims . In markets dealing in intangible goods kinds of â?? transferable development rights â?쳌 that have been ( stocks , intellectual property , or futures ) , principles of in use in many developing countries for decades . ) When good governance require greater market oversight , at the contrasted with genetic resources , for which there is no national or international levels , to protect parties against parallel or template in national or international law , the 63 61 abuse . This is also true of markets that are controlled or ï쳌¦ ï쳌£ ï쳌£ ï쳌£ â?? s provisions and approach are very instructive . limited by one side of the transaction ( trade in gold and Oversight Tools : The Need for International other limited commodities controlled by a small number Cooperation of buyers or sellers ) . On examination , the primary gap in the international The entire realm of access and benefit sharing is basi - regime relates to collaborative action â?? a need that is cally a market in a new intangible commodity â?? genetic much more essential than any additional agreement on resources . However , most ï쳌¡ ï쳌¢ ï쳌³ contracts require that the 62 commitments or terms ( Y ï쳌¯ ï쳌µ ï쳌® ï쳌§ ï?? ï?? ï?? ï?? ) . Cooperation , and terms of the arrangement ( or at least the value given ) 64 a consistent legal framework for that cooperation , is es - must be kept confidential , as a condition of the contract . sential to enable mutual action to enforce ï쳌¡ ï쳌¢ ï쳌³ arrangements Information regarding these matters is essential to the par - involving private entities , academic institutions , etc . ties â?? ( especially the provider countries â?? ) ability to enter Other important services , such as mechanisms for over - confidently into these arrangements , however . This lack sight of the users and uses of genetic resources , interchange of knowledge creates a risk and a fear of entering into a of patenting and other relevant information , and monitor - bad deal and thereby failing in their obligation to protect 65 ing of post - removal compliance with ï쳌¡ ï쳌¢ ï쳌³ arrangements national interests and the public . This fear , in turn leads to might also create economies of scale if shared among more cautious and complex negotiation and approval pro - similarly situated countries . It would be financially very cesses , more detailed legislation , more internal ratification costly and , in some cases , practically much less effective , and verification processes , etc . , which lead commercial to address these needs at the national level , when a single entities to refuse to participate in ï쳌¡ ï쳌¢ ï쳌³ arrangements until solution would be both cheaper and more effective . It is the process can be streamlined . ï?? ï?? ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ The ï쳌£ ï쳌¢ ï쳌¤ Parties have clearly recognized the importance ( people and entities that are not included in theAgreement , of market data in achieving the equity requirements of the but may be injured by it ) against possible system - based convention and of general international commercial law . In abuses . In an international system , it may be that some of ï쳌£ ï쳌¯ ï쳌° - ï?? , for example , they called for , inter alia , â?? information these processes will have to be integrated or harmonized regarding â?¦ ( b ) The market for genetic resources ; ( c ) Non - across national boundaries . The possibility of an interna - 67 monetary benefits ; [ and ] â?¦ ( h ) â?? intermediaries , â?? â?쳌 among tional ombudsman has been suggested in this context . their short list of the information that is â?? a critical aspect In a few cases , specific mechanisms are already under of providing the necessary parity of bargaining power â?¦ discussion , even before the ï쳌£ ï쳌¢ ï쳌¤ â?? s international regime ne - 66 in access and benefit - sharing arrangements â?쳌 . gotiations begin . Many Parties , for example , are seeking A variety of market tools could be adapted to the ï쳌¡ ï쳌¢ ï쳌³ to promote international agreement on specific approaches context , as part of the development of an international and procedures , including the issues of genetic tracking regime , including a ) the registration of transactions ( in - ( using certificates of origin or legal provenance , disclosure cluding or excluding pricing information or the manner of of origin and source in patent applications , etc . ) ( P ï쳌© ï쳌² ï쳌¥ ï쳌³ ï쳌¤ ï쳌¥ calculating benefit - shares ) ; b ) certification ( including cer - C ï쳌¡ ï쳌² ï쳌¶ ï쳌¡ ï쳌¬ ï쳌¨ ï쳌¯ ï?? ï?? ï?? ï?? ) . To some extent , this agreement may be tificates of origin or legal provenance ) of genetic resources , premature â?? it is usually necessary first to come to critical as a prerequisite of use or further transfer ; c ) oversight decisions about the coverage of a system and the nature of institutions and mechanisms ( annual reporting and permit its requirements , before deciding how to implement those requirements ) ; and d ) the creation and empowerment of requirements and adopting specific tools . If such measures oversight bodies , institutions , or frameworks . Contractual are used , it will be necessary to integrate them firmly into protection mechanisms and institutions can also play a key legally mandated processes relating to international trans - role in ensuring that markets are fair where one party to port of genetic material , ï쳌© ï쳌° ï쳌² s , and controls on marketing a financial arrangement has fewer financial resources or and commercialization , so that the user will have a strong less technical or legal sophistication . These measures are incentive to comply with these mechanisms . also necessary to protect the environment and third parties Expectations Insufficiently Realized Finally and briefly , it is important to mention again that the national ï쳌¡ ï쳌¢ ï쳌³ strategy would consist of a single phrase : â?? make lots of money from our genetic resources â?쳌 . In a the ï쳌£ ï쳌¢ ï쳌¤ already obligates all Parties to adopt and imple - few situations , however , particularly countries with low ment measures that will create and support the ï쳌¡ ï쳌¢ ï쳌³ regime , endemism , large indigenous populations , and populations but that as of this writing , only ï?? ï?? have done so . The ï쳌¡ ï쳌¢ ï쳌³ living in traditionally mobile lifestyles , the primary genetic component of the ï쳌£ ï쳌¢ ï쳌¤ is an international framework that resource strategy was identified to be the preservation of was intended to be implemented through national law . genetic resources and the traditional practices associated With only ï?? . ï?? % of Party governments having met this with them ( E ï쳌« ï쳌¨ ï쳌¡ ï쳌³ ï쳌³ ï쳌¡ ï?? ï?? ï?? ï?? ) . Concerns that urbanization obligation , it should be unsurprising that the system is not and modernization will eliminate these important re - functional , despite the fact that ï?? ï?? years have elapsed since sources and knowledge still transferred by oral traditions it was adopted . General implementation is about more than have proven a much stronger motivation than the as - yet - just ï쳌¡ ï쳌¢ ï쳌³ . It is an important tool of the achievement of all unproven expectation of financial and other direct benefits . three ï쳌£ ï쳌¢ ï쳌¤ objectives . The ï쳌· ï쳌³ ï쳌³ ï쳌¤ has recognized that it is This is particularly true in arid and tundra countries , in also a component of broader international objectives such which the volume of species and varieties may be relatively as equalizing participation of developing and developed small , but the number of highly localized endemics quite countries ( with regard to both access and benefits ) , maxi - high . In these countries , it is not generally expected that mizing capacity and understanding , and empowering and income from ï쳌¡ ï쳌¢ ï쳌³ arrangements would ever be sufficient mandating sustainable development as a part of a larger to cover the cost of employment of an ï쳌¡ ï쳌¢ ï쳌³ focal point . contractual reality . However , there are strong interests in protecting genetic ï쳌¡ ï쳌¢ ï쳌³ - related expectations have another face , how - resources and associated traditional knowledge , both as a ever â?? national expectations of the reasons for develop - part of the countryâ??s natural heritage , and as key resources ing a national ï쳌¡ ï쳌¢ ï쳌³ system and of participating in work on ( W ï쳌¹ ï쳌® ï쳌¢ ï쳌¥ ï쳌² ï쳌§ et al . ï?? ï?? ï?? ï?? ) . In other countries ( including de - the international regime . Investigations and workshops veloped countries ) , it has been reported that the primary have demonstrated that most developing countries that motivation underlying their draft access legislation is track - attempt to develop ï쳌¡ ï쳌¢ ï쳌³ legislation have been preoccupied ing and the desire to be aware of ( and have control over ) by possible profits . However , not all countries share this the kinds of research being undertaken and the nature of approach . In the late ï?? ï?? ï?? ï?? s , a brief effort was undertaken to 69 the products that will result . These nonfinancial interests promote the creation of national ï쳌¡ ï쳌¢ ï쳌³ strategies ( ï쳌´ ï쳌¥ ï쳌® K ï쳌¡ ï쳌´ ï쳌¥ have nowhere been addressed in the international regime , and W ï쳌¥ ï쳌¬ ï쳌¬ ï쳌³ ï?? ï?? ï?? ï?? ) . Although this attempt was not ultimately 68 guidance , or model laws developed to date . successful , its results were somewhat surprising . During the discussion of the ï쳌¡ ï쳌¢ ï쳌³ Strategy idea , many quipped that ï?? ï?? ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? ï?? : L ï쳌¥ ï쳌§ ï쳌¡ ï쳌¬ I ï쳌³ ï쳌³ ï쳌µ ï쳌¥ ï쳌³ ï쳌¡ ï쳌® ï쳌¤ ï쳌´ ï쳌¨ ï쳌¥ I ï쳌® ï쳌´ ï쳌¥ ï쳌² ï쳌® ï쳌¡ ï쳌´ ï쳌© ï쳌¯ ï쳌® ï쳌¡ ï쳌¬ R ï쳌¥ ï쳌§ ï쳌© ï쳌­ ï쳌¥ Conclusions and Recommendations At present , the international ï쳌¡ ï쳌¢ ï쳌³ regime , although exist - compromise , so it is important to realize that the ultimate regime is unlikely to live up to the expectations of those ing , is not functional . Usually , where legislation is rather who are most assertive in pressing for the creation of a new sketchy in its direct provisions , it may be â?? fleshed out â?쳌 instrument . One needs only look at the ï쳌£ ï쳌¢ ï쳌¤ â?? s provisions by implementation ( laws , regulations , practices , and relating to biosafety , and compare them to the Cartagena interpretation . ) This often happens with international protocol as finally adopted , to see that there is a dramatic obligations , which become more concrete and imple - difference between pre - negotiation expectations and the mentable when countries adopt legislation to implement actual result . them . Unfortunately , that process has not happened in the Another factor , however , is the unique quality of en - decade since the ï쳌£ ï쳌¢ ï쳌¤ â?? s ï쳌¡ ï쳌¢ ï쳌³ obligations entered into force . vironmental negotiations , as compared with other inter - However , in order for a regime to be implemented through national negotiations . As a general matter , international commercial mechanisms ( contracts and property owner - instruments are negotiated as a way of harmonizing or ship systems ) , it must be complete and consistent â?? capable standardizing activities , conditions , or requirements across of being enforced by the courts and implemented through borders . Negotiations start from a base of national under - legal processes . Moreover , this system must be legally standing both of how the issues are handled at the national consistent internationally . It will be nearly impossible to level and of the nature of particular international problems operate an ï쳌¡ ï쳌¢ ï쳌³ system if the basic definition of genetic or needs . By contrast , international environmental negotia - resources is markedly different from country to country , tions in particular , have increasingly sought to address new for example . issues as potential problems before they can cause expected Serious attention must therefore be given to clarifying harm or to address concerns about harm in advance , so the concepts left vague in the international policy negotia - that those concerns will not cause commercial disruption tions that resulted in the ï쳌£ ï쳌¢ ï쳌¤ . Key definitions that define or have other negative social impacts . Thus , despite com - the nature and coverage of ï쳌¡ ï쳌¢ ï쳌³ , including the terminology plete disagreement at the highest expert levels regarding genetic resources and use of genetic resources , must be the nature of risks ( scientific / biological , economic , and developed and applied . Once the exact nature of genetic social ) inherent in the introduction and consumption of resources has been clarified , then basic inconsistencies in ï쳌§ ï쳌­ ï쳌¯ s , for example , the Cartagena protocol was negoti - their legal ownership must be addressed . Beyond these ated and adopted with impetus from two mandates â?? the most basic hurdles , the ï쳌¡ ï쳌¢ ï쳌³ systemâ??s most serious defi - desire to utilize and market these new innovations and the ciency is its failure to address key financial components of concern that uncontrolled introductions might have serious the creation of a new market in a new kind of commodity . consequences to biodiversity , health , and other factors of It will be essential to develop legal mechanisms to define human livelihoods . that market and provide mechanisms and institutions for Negotiation of the ï쳌£ ï쳌¢ ï쳌¤ identified the use and develop - oversight and transparency of the market and the use rights ment of genetic resources as an activity that might have obtained through it . major impact on conservation in the future . At that time , however , understanding of what it might mean in practice Hard Realities : Negotiation of an was quite limited . The result was an attempt to address International Regime the issue through provisions that were designed to be It is necessary at this point to return to the fact that the somewhat open - ended , but to clearly evince the primary ï쳌£ ï쳌¢ ï쳌¤ is beginning a process which it is calling â?? negotiation objectives and basic commitments of the parties . Fifteen of an international regime on access and benefit sharing â?쳌 . years later , the system has still not been operational , so that While the exact nature of the work that will be done even the new negotiations will not have the advantage of under this description is not yet agreed , it is clear that experience with functional market systems . Accordingly , international work is intended to make some clear prog - the current negotiation of the international regime on ge - ress in creating an effective system . In selecting among netic resources will have to go forward without the benefit options , at each stage of these negotiations , it might be of direct experience in any country . This lack of experi - useful to keep several facts in mind . First is the duration ence also suggests another potential complexity of these of negotiations . Negotiation of the Cartagena Protocol on negotiations â?? the final result will be relatively inflexible Biosafety took more than eight years ( those issues were and extremely difficult to change . International agreements intensively negotiated even before the ï쳌£ ï쳌¢ ï쳌¤ was adopted ) tend to be long lived , and the process of amending them ( K ï쳌¯ ï쳌¥ ï쳌³ ï쳌´ ï쳌¥ ï쳌² ï?? ï?? ï?? ï?? ) . Another key recent negotiation â?? the often takes additional decades following the adoption of Fish Stocks Agreement under ï쳌µ ï쳌® ï쳌£ ï쳌¬ ï쳌¯ ï쳌³ â?? took somewhere the amendment , while the existing parties decide whether 70 between four and ï?? ï?? years , and the Kyoto Protocol to the to ratify or not . During that interim period , both old and UN Framework Convention on Climate Change is taking new versions remain in force , with increasingly complex 71 even longer . Moreover , negotiation is a mechanism of legal rules for their application . ï?? ï?? ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ status of their ï쳌§ ï쳌­ ï쳌¯ products within developing countries Recommendations : Working â?? Outside the that are signatories of the ï쳌£ ï쳌¢ ï쳌¤ . This would also create Box â?? reciprocal business motivations for source countries in the development of their biosafety frameworks . In addition , it One of the most common problems encountered in inter - might give source countries confidence to streamline the national policy forums under the ï쳌£ ï쳌¢ ï쳌¤ is that of repetition . procedures for developing ï쳌¡ ï쳌¢ ï쳌³ arrangements . Where the Many very important issues seem to arise again and again contents of those agreements and procedures are not the in ï쳌£ ï쳌¯ ï쳌° meetings and other high level sessions , each time only bases on which countries may protect their rights and leading to a decision that varies little from past meetings where an international framework exists , governmental and decisions . ï쳌¡ ï쳌¢ ï쳌³ is one example of this phenomenon . negotiators will be able to develop simpler procedures Some part of this repetitive approach can be explained for documenting their decisions and confirming that the by lack of financial resources and capacity in developing interests of the country and its people are adequately countries â?? problems not easily solved . It is possible , how - protected . ever , that by now these oft - repeated statements are only easy solutions that fail to consider the efforts of the past Partners and Partnership ï?? ï?? years . In its initial year , the ï쳌¡ ï쳌¢ ï쳌³ Project has discerned , Another potential new entry into ï쳌¡ ï쳌¢ ï쳌³ is the creation of and partially investigated , a number of possible avenues new kinds of collaboration among the Parties . To date , for new approaches . Two in particular may form part of ï쳌¡ ï쳌¢ ï쳌³ issues have been negotiated in ï쳌£ ï쳌¢ ï쳌¤ Ad Hoc Working the pathway to an effective ï쳌¡ ï쳌¢ ï쳌³ regime . Groups and other committees - of - the - whole , in which countries which are primarily users and those which are Integration and Consistency : Re - linking ABS to Other primarily sources have been called upon to develop con - Genetic Resource Issues ( GMOs and Agriculture ) sensus together on many issues . This approach ignores the One recommendation to the negotiations is to consider re - basic premise of ï쳌¡ ï쳌¢ ï쳌³ work to date â?? that ï쳌¡ ï쳌¢ ï쳌³ is primarily linking the suite of genetic resource issues â?? considering governed by contract . 72 them collectively in the negotiation . There are several From a business perspective , it is essential that each reasons to think such a merger might be useful , but the most side of a contractual negotiation should separately develop important is the possibility of developing useful incentives . its positions based on the particular facts of the individual The complete lack of national ï쳌¡ ï쳌¢ ï쳌³ policies in developed contract , and thereafter negotiate for the best ultimate re - countries ( which would normally be very capable of cre - sult on the basis of this position . Hence , it would not be ating and adopting such measures ) suggests that there is appropriate to pre - negotiate the terms of any agreement little incentive for developed countries to comply with by consensus of both sides of such future negotiations . their ï쳌¡ ï쳌¢ ï쳌³ obligations to develop â?? legislative , administra - Countries that view themselves as primarily suppliers of tive , or policy measures â?쳌 , as described above . In essence , genetic materials ( either of specific types , e.g . , tropical by severing biosafety issues from ï쳌¡ ï쳌¢ ï쳌³ ( and other genetic plants , or more generally ) may find it more useful to de - resource issues ) , the negotiators separated two sides of velop collaborative and consensus positions among them - the market : selves , which could then be used in the international regime â?¢ ï쳌¡ ï쳌¢ ï쳌³ is primarily directed at the source countries â?? negotiations or in the negotiation of ï쳌¡ ï쳌¢ ï쳌³ arrangements issues and desires . themselves . The Group of Like - Minded Megadiverse â?¢ Biosafety and ï쳌§ ï쳌­ ï쳌¯ s , although not the only use made Countries may serve as the first example of this kind of 73 of genetic resources , are certainly of particular collaboration within the international negotiating forums . importance to user countries . Other such groupings , whether regional or based on shared species or situations , may also be possible . Eliminating this unnecessary distinction would em - With regard to negotiation of ï쳌¡ ï쳌¢ ï쳌³ arrangements them - phasize the tie between the primarily - source - country selves , the concept of collective action has thus far re - concerns over access and development and the primarily ceived little attention . Some commentators , however , have user - country concerns regarding the open acceptance of developed some valuable insights into the development products of ï쳌¡ ï쳌¢ ï쳌³ research , including new varieties and of conglomerates of developing countries for purposes especially ï쳌§ ï쳌­ ï쳌¯ s . Even the most difficult definition and of increasing their access to and influence in ï쳌¡ ï쳌¢ ï쳌³ markets coverage issues might be more easily resolved if the full ( V ï쳌¯ ï쳌§ ï쳌¥ ï쳌¬ ï?? ï?? ï?? ï?? ) . This issue may be very important to the range of genetic matters were included in a single frame - future of the international regime . work . At least , negotiators would know that a decision to delete something from ï쳌¡ ï쳌¢ ï쳌³ coverage would not remove it Seller - Oriented Valuation entirely from the ï쳌£ ï쳌¢ ï쳌¤ â?? s governance . One final fact has begun to become obvious in the first In particular , this re - linking would provide a framework year of the ï쳌© ï쳌µ ï쳌£ ï쳌® ï쳌¡ ï쳌¢ ï쳌³ Project â?? the value of genetic re - on which strong incentives could be credibly created and sources has , up to now , been primarily determined by the applied . Rather than the weaker incentive of doing equity , users . There is virtually no objective way of valuing these for example , user countries and institutions might have resources in the absence of clear definitions and market a stronger incentive of improving the market position or information ( and little basis for valuation even then ) . The ï?? ï?? ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? ï?? : L ï쳌¥ ï쳌§ ï쳌¡ ï쳌¬ I ï쳌³ ï쳌³ ï쳌µ ï쳌¥ ï쳌³ ï쳌¡ ï쳌® ï쳌¤ ï쳌´ ï쳌¨ ï쳌¥ I ï쳌® ï쳌´ ï쳌¥ ï쳌² ï쳌® ï쳌¡ ï쳌´ ï쳌© ï쳌¯ ï쳌® ï쳌¡ ï쳌¬ R ï쳌¥ ï쳌§ ï쳌© ï쳌­ ï쳌¥ primary suggested methods of valuation to date relate to it is noted that the cost to countries of their participation the value of the userâ??s end - product ( ï쳌´ ï쳌¥ ï쳌® K ï쳌¡ ï쳌´ ï쳌¥ and L ï쳌¡ ï쳌© ï쳌² ï쳌¤ in an ï쳌¡ ï쳌¢ ï쳌³ system ( institutional development , legislative ï?? ï?? ï?? ï?? ) . Typically , this value is determined based on prior development , personnel commitment , and especially the or similar products , to which some factor ( volumetric cal - costs of oversight and monitoring ) may be significant , even culation or extrapolation of the value of the component if some or all parties develop collaborative mechanisms . that genetic resource are replacing ) is applied . Often , the It is , therefore possible that the value of genetic resources amount is just a flat fee â?? a small percentage of product may be better determined by consideration of the source net profits ( which is determined by the price set for the countryâ??s perspective . product ) . In rare cases , the users have attempted to assign This can be illustrated by one final hypothetical a commercial value to particular species â?? or varieties â?? example â?? suppose Product ï쳌¸ is currently being manu - genetic material , but again the basis of that valuation is factured using chicken eggs as a primary ingredient . It is 74 difficult to justify . then discovered that Product ï쳌¸ is much improved if caviar There are some apparent flaws in this approach to valu - is substituted for chicken eggs , creating a new product 0 ation , however . First , the ï쳌¡ ï쳌¢ ï쳌³ provisions are not focused ( Product ï쳌¸ . ) In paying for the ingredients , it is not ap - on the value of the resource as used , but on an equitable propriate to value the caviar according to the former cost 0 share of the benefits . In this case , the objective of equity ap - of eggs . Instead , the cost of Product ï쳌¸ is greater than pears to be the compensation of countries for their historic that of Product ï쳌¸ , reflecting the increased ingredient cost , contribution â?? that is , for their actions ( conservation and including the costs of obtaining permits to acquire and 75 responsible land stewardship ) or omissions to act ( the fact import caviar , and any national conditions imposed on that they did not develop lands , but left them in a natural the harvesting of caviar , to ensure that such harvests are state ) . These contributions resulted in the protection and sustainable and use environmentally sound methods . continued existence of entire ecosystems , not only the The most valuable contribution anyone can make to individual species . these negotiations will be a willingness to think outside Even apart from the question of equity - based valua - the box . The negotiations must dig deeper into existing tion , the user orientation of current valuation fails to take assumptions about ï쳌¡ ï쳌¢ ï쳌³ , its operations , and potential , as account of some serious ï쳌¡ ï쳌¢ ï쳌³ - related issues . Especially , well as its limitations . Acknowledgements This chapter reflects the expert opinion of the author only reasons for its apparent failure to meet expectations , and and does not reflect the view and positions of î?? î?° î?? î?? . Much of solutions based on expert advice and analysis for critical the analysis of this chapter is supported by the initial work legal impediments to compliance . The Project gives par - of the ï쳌© ï쳌µ ï쳌£ ï쳌® ï쳌¡ ï쳌¢ ï쳌³ Project ( of which the author is project man - ticular attention to researching unproven assumptions and ager ) , a three - year project of the ï쳌© ï쳌µ ï쳌£ ï쳌® Environmental Law frequently restated conditions , â?? facts â?쳌 , and objectives that Center , financed by the German Ministry for Development have not been formally studied and confirmed . Interested Cooperation ( ï쳌¢ ï쳌­ ï쳌º ) . The objective of the ï쳌¡ ï쳌¢ ï쳌³ Project is readers are invited to find out more about the Project from to provide concrete research delving into the ï쳌¡ ï쳌¢ ï쳌³ issue , its website at http : / / www.iucn.org / themes / law / abs ï?? ï?? . html the manner in which it has been addressed up to now , the or from the project manager at tyoung @ iucn.org . References A ï쳌® ï쳌¤ ï쳌¥ ï쳌¡ ï쳌® C ï쳌¯ ï쳌­ ï쳌­ ï쳌µ ï쳌® ï쳌© ï쳌´ ï쳌¹ . ï?? ï?? ï?? ï?? . Decision ï?? ï?? ï?? : Common ing the biological richness of the area ( an initial inquiry ) . p . ï?? ï?? in As knowledge evolves : Applying the Marine regime on access to genetic resources . http : / / Governance Regime to recent genetic resource discover - www.comunidadandina.org / ingles / treaties / dec / d ï?? ï?? ï?? e.htm . ies . ï쳌© ï쳌µ ï쳌£ ï쳌® / ï쳌¢ ï쳌­ ï쳌º , Bonn , Germany . C ï쳌¡ ï쳌¢ ï쳌² ï쳌¥ ï쳌² ï쳌¡ J . ï?? ï?? ï?? ï?? . A comparative analysis on the legislation B ï쳌² ï쳌¯ ï쳌· ï쳌® ï쳌¬ ï쳌© ï쳌¥ L . ï?? ï?? ï?? ï?? . Principles of public international law . and practices on access to genetic resources and benefit Oxford Press , ï?? rd Edition , London , ï쳌µ ï쳌« and New York , sharing ( ABS ) : Critical aspects for implementation and ï쳌µ ï쳌³ ï쳌¡ . interpretation . ï쳌© ï쳌µ ï쳌£ ï쳌® / ï쳌¢ ï쳌­ ï쳌º , Bonn , Germany . C ï쳌¨ ï쳌© ï쳌³ ï쳌¨ ï쳌¡ ï쳌« ï쳌· ï쳌¥ N . and T . Y ï쳌¯ ï쳌µ ï쳌® ï쳌§ . ï?? ï?? ï?? ï?? . Access to genetic ï쳌£ ï쳌¢ ï쳌¤ Secretariat and ï쳌µ ï쳌® ï쳌¤ ï쳌¯ ï쳌¡ ï쳌¬ ï쳌¯ ï쳌³ ï?? ï?? ï?? ï?? . Conservation and resources , and sharing the benefits : International and sustainable use of deep seabed genetic resources beyond sub - regional Issues . ï쳌© ï쳌µ ï쳌£ ï쳌® / ï쳌¢ ï쳌­ ï쳌º , Bonn , Germany . national jurisdiction : Study of the relationship between the Convention on Biological Diversity and the United E ï쳌« ï쳌¨ ï쳌¡ ï쳌³ ï쳌³ ï쳌¡ B . ï?? ï?? ï?? ï?? . La plantation des acacias . Abstract of Nations Convention on the Law of the Sea . ï쳌µ ï쳌® ï쳌¥ ï쳌° / ï쳌£ ï쳌¢ ï쳌¤ / presentation at the ï?? st Inter - Regional Session of the ï쳌³ ï쳌¢ ï쳌³ ï쳌´ ï쳌´ ï쳌¡ / ï?? / ï?? / Add . ï?? / Rev . ï?? . ï쳌µ ï쳌² ï쳌¬ : http : / / www.biodiv.org / doc / Global Biodiversity Forum : Integrating Biodiversity meetings / sbstta / sbstta - ï?? ï?? / official / sbstta - ï?? ï?? - ï?? ï?? - add ï?? - rev ï?? - Conservation and Livelihood Security . Havana , Cuba . en.pdf . G ï쳌¬ ï쳌¯ ï쳌· ï쳌« ï쳌¡ L . ï?? ï?? ï?? ï?? . The next rosy periwinkle wonâ??t be free : B ï?¹ ï쳌¡ ï쳌º ï쳌« ï쳌© ï쳌¥ ï쳌· ï쳌© ï쳌£ ï쳌º B . ï?? ï?? ï?? ï?? . Raising the floor : Legal issues regard - Emerging legal frameworks to implement Article ï?? ï?? . ï?? ï?? ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ Environmental Policy and Law ï?? ï?? : ï?? ï?? ï?? â?? ï?? ï?? ï?? . S ï쳌£ ï쳌¨ ï쳌¬ ï쳌¯ ï쳌³ ï쳌³ ï쳌¥ ï쳌² E . ï?? ï?? ï?? ï?? . Fast food nation . Perennial , New York , ï쳌® ï쳌¹ ï쳌µ ï쳌³ ï쳌¡ . G ï쳌¬ ï쳌¯ ï쳌· ï쳌« ï쳌¡ L . ï?? ï?? ï?? ï?? . A guide to designing legal frameworks to determine access to genetic resources . Environmental S ï쳌· ï쳌© ï쳌¤ ï쳌¥ ï쳌² ï쳌³ ï쳌« ï쳌¡ K . ï?? ï?? ï?? ï?? . Stakeholder participation in policy on Policy and Law Paper No . ï?? ï?? . Environmental Law Center , access to genetic resources , traditional knowledge and ï쳌© ï쳌µ ï쳌£ ï쳌® , Gland , Switzerland , Cambridge , ï쳌µ ï쳌« and Bonn , benefit - sharing : Case studies and recommendations . Germany . Biodiversity and Livelihoods Issues , vol . ï?? . International K ï쳌¯ ï쳌¥ ï쳌³ ï쳌´ ï쳌¥ ï쳌² V . , ï?? ï?? ï?? ï?? . Excellence in the art of the possible . ï쳌© ï쳌µ ï쳌£ ï쳌® Institute for Environment and Development , London , ï쳌µ ï쳌« . Environmental Law Newsletter , vol . ï?? ï?? ï?? ï?? / ï?? , Bonn , ï쳌µ ï쳌² ï쳌¬ : http : / / www.iied.org / docs / blg / synthesis_final.pdf . Germany . ï쳌´ ï쳌¥ ï쳌® K ï쳌¡ ï쳌´ ï쳌¥ K . and S.A . L ï쳌¡ ï쳌© ï쳌² ï쳌¤ . ï?? ï?? ï?? ï?? . The commercial use of M ï쳌¡ ï쳌£ ï쳌« ï쳌¥ ï쳌® ï쳌³ ï쳌© ï쳌¥ R . , F . B ï쳌µ ï쳌² ï쳌¨ ï쳌¥ ï쳌® ï쳌® ï쳌¥ - G ï쳌µ ï쳌© ï쳌¬ ï쳌­ ï쳌© ï쳌® , A.G.M . L ï쳌¡ V ï쳌© ï?± ï쳌¡ , biodiversity : Access to genetic resources and benefit - and J.D . W ï쳌¥ ï쳌² ï쳌« ï쳌³ ï쳌­ ï쳌¡ ï쳌® . ï?? ï?? ï?? ï?? . An explanatory guide to the sharing . Earthscan . London , ï쳌µ ï쳌« . Cartagena Protocol on Biosafety . ï쳌© ï쳌µ ï쳌£ ï쳌® Environmental ï쳌´ ï쳌¥ ï쳌® K ï쳌¡ ï쳌´ ï쳌¥ K . and A . W ï쳌¥ ï쳌¬ ï쳌¬ ï쳌³ . ï?? ï?? ï?? ï?? . Preparing a national strat - Policy and Law Paper No . ï?? ï?? , ï쳌¦ ï쳌© ï쳌¥ ï쳌¬ ï쳌¤ . Bonn , Germany . egy on access to genetic resources and benefit sharing : A O ï쳌² ï쳌¬ ï쳌¡ ï쳌® ï쳌¤ ï쳌¯ B . , D . B ï쳌¡ ï쳌¬ ï쳌¤ ï쳌¯ ï쳌£ ï쳌« , S . C ï쳌¡ ï쳌® ï쳌ª ï쳌¥ ï쳌² , J . M ï쳌¡ ï쳌£ ï쳌« ï쳌¥ ï쳌® ï쳌³ ï쳌¥ ï쳌® , pilot study . Royal Botanic Gardens Kew , ï쳌µ ï쳌« . ï쳌µ ï쳌² ï쳌¬ : http : S . M ï쳌¡ ï쳌§ ï쳌© ï쳌® ï쳌® ï쳌© ï쳌³ , M.S . M ï쳌¡ ï쳌® ï쳌§ ï쳌µ ï쳌© ï쳌¡ ï쳌´ , S . R ï쳌© ï쳌¥ ï쳌´ ï쳌¢ ï쳌¥ ï쳌² ï쳌§ ï쳌¥ ï쳌® , C . / / www.undp.org / bpsp / thematic_links / docs / ABS_Manual_ R ï쳌¯ ï쳌¢ ï쳌¬ ï쳌¥ ï쳌¤ ï쳌¯ , N . S ï쳌£ ï쳌¨ ï쳌® ï쳌¥ ï쳌© ï쳌¤ ï쳌¥ ï쳌² . ï?? ï?? ï?? ï?? . Carbon , forests and RBGK.pdf . people : Towards the integrated management of carbon se - T ï쳌¯ ï쳌¢ ï쳌© ï쳌® , B . and K . S ï쳌· ï쳌© ï쳌¤ ï쳌¥ ï쳌² ï쳌³ ï쳌« ï쳌¡ . ï?? ï?? ï?? ï?? Speaking in tongues : questration , the environment and sustainable livelihoods . Indigenous participation in the development of a sui ï쳌© ï쳌µ ï쳌£ ï쳌® Occasional Paper , Gland , Switzerland . generis regime to protect traditional knowledge in Peru . P ï쳌¡ ï쳌´ ï쳌´ ï쳌¯ ï쳌® S . ï?? ï?? ï?? ï?? . The ecological significance of seamounts : Participation in Access and Benefit - Sharing Policy Threats and conservation . p . ï?? in As knowledge evolves : Case Study No ï?? . Biodiversity and Livelihoods Group , Applying the Marine Governance Regime to recent ge - International Institute for Environment and Development , netic resource discoveries . ï쳌© ï쳌µ ï쳌£ ï쳌® / ï쳌¢ ï쳌­ ï쳌º , Bonn , Germany London , ï쳌µ ï쳌« . ï쳌µ ï쳌² ï쳌¬ : http : / / www.iied.org / docs / blg / P ï쳌¥ ï쳌² ï쳌© ï쳌¡ E . ï?? ï?? ï?? ï?? . The ASEAN framework agreement on ac - perustudy.pdf . cess to genetic resources : An access instrument or impediment ? ï?? ï?? th Global Biodiversity Forum : Sharing V ï쳌¯ ï쳌§ ï쳌¥ ï쳌¬ J . ï?? ï?? ï?? ï?? . Conclusion : An economic justification for the Benefits from Biodiversity . Unpublished manuscript . the cartel and a special protocol for the Convention on Nairobi , Kenya . Biological Diversity . p . ï?? ï?? ï?? â?? ï?? ï?? ï?? in J . Vogel ( ed . ) The bio - P ï쳌© ï쳌² ï쳌¥ ï쳌³ ï쳌¤ ï쳌¥ C ï쳌¡ ï쳌² ï쳌¶ ï쳌¡ ï쳌¬ ï쳌¨ ï쳌¯ N . ï?? ï?? ï?? ï?? . Requiring disclosure of the diversity cartel : Transformation of traditional knowledge origin of genetic resources and prior informed con - into trade secrets . ï쳌£ ï쳌¡ ï쳌² ï쳌¥ , Proyecto ï쳌³ ï쳌µ ï쳌¢ ï쳌© ï쳌² . Quito , Ecuador . sent in patent applications without infringing the ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ W ï쳌¹ ï쳌® ï쳌¢ ï쳌¥ ï쳌² ï쳌§ R . , L . H ï쳌¡ ï쳌© ï쳌¤ ï쳌¡ ï쳌² , W . N ï쳌¡ ï쳌³ ï쳌³ ï쳌¥ ï쳌² , and A . G ï쳌¡ ï쳌² ï쳌¡ ï쳌® ï쳌¥ . ï?? ï?? ï?? ï?? . agreement : The problem and the solution . Washington Biodiversity access and benefit - sharing in arid countries University Journal of Law and Policy ï?? : ï?? ï?? ï?? â?? ï?? ï?? ï?? . and those with low diversity and high endemism . ï쳌© ï쳌µ ï쳌£ ï쳌® / R ï쳌µ ï쳌© ï쳌º M . ( ed . ) ï?? ï?? ï?? ï?? . Regional workshop on the synergies be - ï쳌¢ ï쳌­ ï쳌º , Bonn , Germany . tween the Convention on Biological Diversity and ï쳌£ ï쳌© ï쳌´ ï쳌¥ ï쳌³ Y ï쳌¯ ï쳌µ ï쳌® ï쳌§ T . ï?? ï?? ï?? ï?? . Instruments in the existing international regarding access to genetic resources and distribution of regime on ABS : A coverage analysis . ï쳌© ï쳌µ ï쳌£ ï쳌® / ï쳌¢ ï쳌­ ï쳌º , Bonn benefits : The role of the certificates of origin . ï쳌© ï쳌µ ï쳌£ ï쳌® / ï쳌¢ ï쳌­ ï쳌º , Germany ( forthcoming ) . Bonn , Germany . Endnotes 1 Primarily for purposes of length , this paper does not address the Decisions ï쳌© / ï?? , ï쳌© ï쳌© / ï?? ï?? , ï쳌© ï쳌© ï쳌© / ï?? ï?? , ï쳌© ï쳌¶ / ï?? , ï쳌¶ / ï?? ï?? , ï쳌¶ ï쳌© / ï?? ï?? and ï쳌¶ ï쳌© / ï?? ï?? ( decisions issues of â?? traditional knowledge â?쳌 as expressed in the Convention focused on ï쳌¡ ï쳌¢ ï쳌³ . The issue arises in other decisions as well . ) It is on Biological Diversity and elsewhere , except in the sense that integrally related to other controversial issues and negotiations , in - some kinds of â?? genetic - resource - related traditional knowledge â?쳌 cluding especially the Cartagena Protocol on Biosafety ( Montréal , will be subject to the same legal development and analysis that ï?? ï?? ï?? ï?? , entry into force , ï?? ï?? Sept . ï?? ï?? ï?? ï?? . ) Reports of ï쳌£ ï쳌¢ ï쳌¤ ï쳌£ ï쳌¯ ï쳌° and ï쳌© ï쳌® ï쳌£ is being slowly developed and molded into a body of law on meetings as well as the ï쳌© ï쳌® ï쳌£ and ï쳌£ ï쳌¯ ï쳌° - ï쳌­ ï쳌¯ ï쳌° meetings of the Cartagena genetic resources . It is the development of the latter body of law Protocol are all available on - line at the ï쳌£ ï쳌¢ ï쳌¤ Secretariat website at that this paper addresses . Traditional knowledge issues are very http : / / www.biodiv.org . differently expressed in the ï쳌£ ï쳌¢ ï쳌¤ ( see , e.g . , Articles ï?? ( j ) and ï?? ï?? ( c ) 3 ï쳌£ ï쳌¢ ï쳌¤ Resolution ï쳌¶ ï쳌© - ï?? ï?? . ï쳌µ ï쳌® Document ï쳌µ ï쳌® ï쳌¥ ï쳌° / ï쳌£ ï쳌¢ ï쳌¤ / ï쳌£ ï쳌¯ ï쳌° / ï?? / L - ï?? ï?? , avail - of the Convention ) which creates a mandate that is from a legal able on the ï쳌£ ï쳌¢ ï쳌¤ website ( see note ï?? ) . perspective both very different and very much broader than the ï쳌¡ ï쳌¢ ï쳌³ 4 systemic mandate that is discussed in this paper . It is hoped that the In this connection , it should be noted that the ï쳌· ï쳌³ ï쳌³ ï쳌¤ was an interna - creation of a functional and effective regime on ï쳌¡ ï쳌¢ ï쳌³ will provide a tional forum with no direct legal mandate . As such , its outputs are key component that will help in the development of the much more aspirational rather than mandatory or even â?? good faith â?쳌 commit - inclusive issues of traditional knowledge and the biodiversity - re - ments . They are less binding than either Conventions or ï쳌£ ï쳌¯ ï쳌° resolu - lated rights of indigenous , mobile and rural peoples . tions . 2 Convention on Biological Diversity ( entry into force December 5 ï쳌µ ï쳌® ï쳌¥ ï쳌° / ï쳌£ ï쳌¢ ï쳌¤ / ï쳌£ ï쳌¯ ï쳌° / ï?? / ï?? later generally adopted by the ï쳌£ ï쳌¢ ï쳌¤ Conference ï?? ï?? ï?? ï?? ) . The nature and implementation of ï쳌¡ ï쳌¢ ï쳌³ has been an impor - of Parties through decision ï쳌¶ ï쳌© ï쳌© / ï?? ï?? ( ï쳌µ ï쳌® Document ï쳌µ ï쳌® ï쳌¥ ï쳌° / ï쳌£ ï쳌¢ ï쳌¤ / ï쳌£ ï쳌¯ ï쳌° / ï?? / tant and somewhat controversial topic from the earliest negotia - ï쳌¬ . ï?? ï?? . ) , available on the ï쳌£ ï쳌¢ ï쳌¤ website ( see note ï?? ) . tions leading to the Convention . It has appeared in some form in 6 ï쳌µ ï쳌® Document ï쳌µ ï쳌® ï쳌¥ ï쳌° / ï쳌£ ï쳌¢ ï쳌¤ / ï쳌£ ï쳌¯ ï쳌° / ï?? / ï쳌¬ . ï?? ï?? , available on the ï쳌£ ï쳌¢ ï쳌¤ website every international negotiating committee ( ï쳌© ï쳌® ï쳌£ ) and Conference of the Parties ( ï쳌£ ï쳌¯ ï쳌° ) since the Convention was adopted . See , e.g . , ( see note ï?? ) . ï?? ï?? ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? ï?? : L ï쳌¥ ï쳌§ ï쳌¡ ï쳌¬ I ï쳌³ ï쳌³ ï쳌µ ï쳌¥ ï쳌³ ï쳌¡ ï쳌® ï쳌¤ ï쳌´ ï쳌¨ ï쳌¥ I ï쳌® ï쳌´ ï쳌¥ ï쳌² ï쳌® ï쳌¡ ï쳌´ ï쳌© ï쳌¯ ï쳌® ï쳌¡ ï쳌¬ R ï쳌¥ ï쳌§ ï쳌© ï쳌­ ï쳌¥ 7 In this paper , the word â?? regime â?쳌 is used to mean the â?? totality of Sustainable Use principles . Others , including ones on technology transfer , incentives , and liability , are being discussed . norms , rules , standards , and procedures as expressed in interna - tional and national law instruments and other formal documents 22 ï쳌£ ï쳌© ï쳌´ ï쳌¥ ï쳌³ entered into force in ï?? ï?? ï?? ï?? and the Montreal Protocol on relevant to the subject â?쳌 ( in this case ï쳌¡ ï쳌¢ ï쳌³ ) . Substances that Deplete the Ozone Layer came into force in ï?? ï?? ï?? ï?? . 8 The Protocol was also amended in ï?? ï?? ï?? ï?? and ï?? ï?? ï?? ï?? . An explanatory guide to the ï쳌© ï쳌´ ï쳌° ï쳌§ ï쳌² ï쳌¦ ï쳌¡ , written by Gerald Moore and Witold Tymowsky is currently in the final editing process , with 23 This general perception is a function of the prominence of the first English publication under the auspices of the ï쳌¡ ï쳌¢ ï쳌³ Project expected major ï쳌¡ ï쳌¢ ï쳌³ arrangement ( the InBio - Merck Contract detailed in Reid , by the close of ï?? ï?? ï?? ï?? . For more information , and electronic cop - W . , et al ( ï?? ï?? ï?? ï?? ) Biodiversity prospecting : Using biodiversity for ies when available , see the ï쳌© ï쳌µ ï쳌£ ï쳌® ï쳌¡ ï쳌¢ ï쳌³ Project website ( î?° î?« î?? : http : sustainable development . World Resource International ) , coupled / / www.iucn.org / themes / law / abs ï?? ï?? . htm ) . with its frequent description of its overall program ( national institu - 9 tional arrangements and InBio â?? a public - private entity ) as having Recital ï?? ï?? of this directive provides that the patent application more than ï?? ï?? existing contracts on which users are reporting , with should , where appropriate , include information on the geographi - the post - script that other private arrangements are not included . cal origin of biological material if known . Although this is entirely voluntary , as it is without prejudice to the processing of patent 24 The excellent Costa Rican system ( including a comprehensive applications or the validity of rights arising from granted patents , legislative and institutional structure ) , for example , has been it remains one of the few developed - country laws that address any developed with very substantial levels of donor assistance over ï쳌¡ ï쳌¢ ï쳌³ issues directly . more than a decade . Presentation of Rodrigo Gámez , Instituto 10 Nacional de Biodiversidad ( ï쳌© ï쳌® ï쳌¢ io ) , ï?? th Norway / ï쳌µ ï쳌® Conference on The ï쳌£ ï쳌¢ ï쳌¤ â?? s ï쳌¡ ï쳌¢ ï쳌³ commitments , as discussed below , are quite specific , Biodiversity ( Trondheim , ï?? ï?? ï?? ï?? ) . More than ï?? ï?? years after its incep - and relate to kinds of property that have not been recognized in tion , however , the amount of income received from this system is law prior to ï?? ï?? ï?? ï?? . Accordingly , the claims that national contract far overshadowed by this ongoing external assistance . Among the and commercial law , without additional amendment , is sufficient to primary payments received from user entities under access con - satisfy the Parties â?? ï쳌¡ ï쳌¢ ï쳌³ commitments suggests a need for further in - tracts to date have been in - kind donations of equipment for ï쳌© ï쳌® ï쳌¢ ioâ??s quiry . This work is in process under the auspices of the ï쳌¡ ï쳌¢ ï쳌³ Project operations . To date , post - access â?? benefit - sharing â?쳌 provisions have ( ï쳌© ï쳌µ ï쳌£ ï쳌® / ï쳌¢ ï쳌­ ï쳌º ) , with a final publication expected in ï?? ï?? ï?? ï?? . not been applicable , as none of the pharmaceutical companies has 11 Judicial interpretation of private instruments with relevant legal â?? hit â?쳌 on a compound triggering such payments . This strongly sug - effectiveness are also a key component of any legal regime . gests that the Costa Rican example is not replicable . It is probably 12 Most ï쳌¡ ï쳌¢ ï쳌³ contracts are between a government entity in the source not reasonable to expect this level of support to be generally pro - country and a private entity or academic institution . Even where vided to the more - than - ï?? ï?? developing countries , and to countries in such agreements may , by law , be directly negotiated with the owner economic transition . Moreover , it is not clear that there is sufficient of the property from which the samples are to be taken , govern - level of demand to ensure that ï?? ï?? or more comprehensive programs ment oversight or approval of the agreement may be required of this type would be as operationally successful as the govern - ( T ï쳌¯ ï쳌¢ ï쳌© ï쳌® and S ï쳌· ï쳌© ï쳌¤ ï쳌¥ ï쳌² ï쳌³ ï쳌« ï쳌¡ ï?? ï?? ï?? ï?? ) . ment - owned genetic - resource research and collection institution 13 In this paper , the term â?? regulated public â?쳌 simply refers to the group ( ï쳌© ï쳌® ï쳌¢ io ) has become . whose activities or status is covered by the law . 25 Although a very small number of corporate entities remain 14 ï쳌£ ï쳌¢ ï쳌¤ Article ï?? . The quoted material is enhanced by the next phrase involved in ï쳌¡ ï쳌¢ ï쳌³ negotiations , this number has diminished ( and con - in Article ï?? : â?? including by appropriate access to genetic resources tinues to do so ) over the past decade . In many instances , after an and by appropriate transfer of relevant technologies , taking into agreement is partly negotiated , additional legislative / institutional account all rights over those resources and to technologies , and by restrictions or requirements are discovered which add to previous appropriate funding â?쳌 . transaction costs throwing the total above a corporationâ??s declared 15 willingness to pay . In addition to the ï?? ï?? binding commitments in text , the parties are 26 subject to one nonmandatory provision that is particularly relevant As noted above , the ï쳌£ ï쳌¢ ï쳌¤ â?? s provisions focus solely on governmental to ï쳌¡ ï쳌¢ ï쳌³ â?? the commitment to â?? consider strengthening existing finan - processes . And the requirements of Prior Informed Consent ( ï쳌° ï쳌© ï쳌£ ) cial institutions to provide financial resources for the conservation and Mutually Agreed Terms ( ï쳌­ ï쳌¡ ï쳌´ ) as written in the Convention and sustainable use of biological diversity â?쳌 ( Art . ï?? ï?? . ï?? ) . refer only to getting informed consent from , and negotiating terms 16 with , the national government . Hence it is a matter of national All section references are to the ï쳌£ ï쳌¢ ï쳌¤ unless otherwise noted . domestic governance whether and how the source countryâ??s gov - 17 As of this writing , there are ï?? ï?? ï?? parties to the ï쳌£ ï쳌¢ ï쳌¤ , and one other ernmental system delegates its rights to information and responsi - country signed the Convention in ï?? ï?? ï?? ï?? , but has never ratified it . bilities regarding consent and terms . These matters are outside the ( Information from ï쳌¥ ï쳌£ ï쳌¯ ï쳌¬ ï쳌¥ ï쳌¸ , a continuously updated ï쳌© ï쳌µ ï쳌£ ï쳌® / ï쳌¦ ï쳌¡ ï쳌¯ / purview of the Convention . ï쳌µ ï쳌® ï쳌¥ ï쳌° environmental law database , now available online at http : 27 See Acknowledgements . / / www.ecolex.org . ) 28 18 This is not a failing of the negotiations , but a â?? growing pain â?쳌 of the Some countries have enacted legislation that says that any international law process . In the past , international law ( other than international agreement that the government ratifies or accedes peace treaties and trade agreements , both of which are essentially to becomes the law of the land . These provisions would be very contracts between sovereign governments ) was created where difficult to apply in practice , since international treaties do not many countries had adopted principles on a particular subject , and specify rights , duties , or potential liabilities of individuals and the it appeared valuable to develop a single mutually agreed consen - civil society . However , this â?? blanket legislation â?쳌 is still national sus - based statement about them . The ï쳌£ ï쳌¢ ï쳌¤ is part of an evolution legislation , and is the vehicle by which those requirements become away from this . Given that biodiversity will be irretrievably lost binding on persons and entities within such countries . if not protected immediately , the ï쳌£ ï쳌¢ ï쳌¤ seeks to address issues and 19 ï쳌£ ï쳌¢ ï쳌¤ Article ï?? ï?? . ï?? ( emphasis added . ) problems that are generally recognized to be coming , but not yet 20 There are some â?? framework â?쳌 instruments that are not â?? policy - present . The speed of ideas and development is such that , where style â?쳌 . In particular , the United Nations Convention on the Law of possible , such problems must be governed before they are actu - the Sea provides regulatory levels of detail on a great many issues , ally seen on the ground . Unfortunately , however , this means that but still provides a comprehensive framework under which other conventions like the ï쳌£ ï쳌¢ ï쳌¤ must take action before there is direct instruments can be developed . experience on the particular issue at the national level . Specialists 21 ï쳌£ ï쳌¢ ï쳌¤ framework tools include the Ecosystem Approach and the participating in such negotiations are rarely experts in all of the ï?? ï?? ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ subject areas that may be impacted . In the case of the ï쳌£ ï쳌¢ ï쳌¤ , it expected in ï?? ï?? ï?? ï?? . 41 appears that the experts involved were experts in law relating to ï쳌£ ï쳌¢ ï쳌¤ , Article ï?? . conservation , but that no experts in contract law or ( real and intel - 42 ï쳌£ ï쳌¢ ï쳌¤ , Article ï?? . ï?? . lectual ) property rights participated in or advised the negotiations . 43 ï쳌£ ï쳌¢ ï쳌¤ , Article ï?? . 29 As noted below , ownership of land ( and many other kinds of physi - 44 Entered into force in ï?? ï?? ï?? ï?? . cal property ) is really an intangible concept , but is undisputedly 45 linked to a particular physical area , and thus , essentially , tangible . A similar statement about our lack of complex understanding of the issue will undoubtedly be made by those who analyse the outcomes 30 See ï쳌£ ï쳌¢ ï쳌¤ Articles ï?? , ï?? , and ï?? . In furtherance of this approach all ï쳌£ ï쳌¢ ï쳌¤ of the coming negotiation of the international ï쳌¡ ï쳌¢ ï쳌³ regime . ï쳌£ ï쳌¯ ï쳌° decisions adopting workplans or specifying action focus on 46 either recommending action at the national level or providing tools Even in this example , of course , there was eventually a need for for such action . Even provisions relating to regional cooperation new laws to address minimum standards of safety and quality and meet with resistance in ï쳌£ ï쳌¯ ï쳌° discussions from parties who note that to ensure that frequency markings were uniform on all radios tuned the ï쳌£ ï쳌¢ ï쳌¤ is implemented by national action . to particular bands . 31 47 The Convention on Migratory Species ( Bonn , ï?? ï?? ï?? ï?? , entry into The ï쳌£ ï쳌¢ ï쳌¤ Parties have noted a number of other definitional issues on force in ï?? ï?? ï?? ï?? ) which predates the ï쳌£ ï쳌¢ ï쳌¤ , is now working under a which they believe clarification is needed , including those relating joint program of work to ensure the integration of international to â?? access to genetic resources â?쳌 , â?? benefit sharing â?쳌 , â?? commercial - protections of migratory species with national implementation of ization â?쳌 , â?? derivatives â?쳌 , â?? provider â?쳌 , â?? user â?쳌 , â?? stakeholder â?쳌 , â?? ex situ ï쳌£ ï쳌¢ ï쳌¤ objectives and programs of work . See Decision ï쳌¶ ï쳌© - ï?? ï?? ( http : collection â?쳌 , â?? voluntary nature â?쳌 , and possibly â?? arbitrary restric - / / www.biodiv.org ) . tions â?쳌 . See Decision ï쳌¶ ï쳌© ï쳌© / ï?? ï?? , ï쳌µ ï쳌® Document ï쳌µ ï쳌® ï쳌¥ ï쳌° / ï쳌£ ï쳌¢ ï쳌¤ / ï쳌£ ï쳌¯ ï쳌° / ï?? / ï쳌¬ . ï?? ï?? . 32 While a number of interesting issues exist with regard to this ter - This point is interesting in itself . Nearly all other aspects of the ï쳌£ ï쳌¢ ï쳌¤ minology , this paper will not examine any of these issues . Further specifically address both purely domestic activities ( within national work on them will be done through the ï쳌© ï쳌µ ï쳌£ ï쳌® ï쳌¡ ï쳌¢ ï쳌³ Project , however . boundaries , jurisdiction , and sovereignty ) and those that cross 48 national borders , whether physically or in other ways . See , e.g . , Article ï?? ï?? and relevant parts of Articles ï?? ï?? and ï?? ï?? of the ï쳌£ ï쳌¢ ï쳌¤ Article ï?? ( ex - situ conservation ) which includes specific discussions specify that they are applicable to genetic resources , where the of many matters of national jurisdiction , including land and water rest of the operative provisions of the convention are specifically matters ( which are typically among the most protected concepts in applicable to biological resources . ï쳌£ ï쳌¯ ï쳌° decisions on ï쳌¡ ï쳌¢ ï쳌³ have been national sovereign jurisdiction ) and indigenous peoples . Even as to carefully limited to genetic resources . the discussions of â?? alien species which threaten ecosystems â?쳌 ( arti - 49 It is notable that , in international law , â?? legislative history â?쳌 is cle ï?? ( h ) ) , it has been noted that unless speaking of human beings , usually not considered to be a reliable guide to interpretation the term â?? alien â?쳌 does not refer to nationality . Hence , this paragraph ( B ï쳌² ï쳌¯ ï쳌· ï쳌® ï쳌¬ ï쳌© ï쳌¥ ï?? ï?? ï?? ï?? ) . Relatively few international forums include ver - refers to â?? species not normally found in a particular ecosystem â?쳌 batim transcription of debates leading to new instruments or deci - ( whether domestic or foreign ) rather than â?? species brought in from sions . Even where some portion of the deliberations are memorial - other countries â?쳌 . The specific avoidance by ï쳌¡ ï쳌¢ ï쳌³ provisions of any ised in nonverbatim reports ( e.g . , â?? report of the meeting â?쳌 or â?? report mention of domestic ï쳌¡ ï쳌¢ ï쳌³ governance is very noticeable in this of the session â?쳌 ) , those reports usually only encompass the plenary context . discussions and / or discussions from within formal working groups . 33 In the final version , the Bonn Guidelines speak of the responsibility However , as to matters of controversy , it is common to create other of user countries , as well as users . informal groupings including â?? contact groups â?쳌 and â?? friends of the 34 chair â?쳌 . In some cases , these meetings are only available to specified ï쳌¦ ï쳌¡ ï쳌¯ Conference Resolutions ï?? / ï?? ï?? and ï?? / ï?? ï?? ( http : / / www.fao.org / ) . delegates . These deliberations although never reported frequently 35 ï쳌£ ï쳌¢ ï쳌¤ Article ï?? , definitions of â?? country of origin â?쳌 and â?? in - situ condi - return to the meeting with a new text that is simply presented and tions â?쳌 . reported as the agreement of the Contact Group . Finally , where 36 In many cases , genetic resources vary widely at taxonomic levels a wide - ranging discussion has taken place ( in working groups , below the basic â?? species â?쳌 level . Particular varieties ( subspecies that contact groups , ï쳌¦ ï쳌¯ ï쳌£ groupings , and elsewhere ) , the Chair may have been bred to consistently possess particular qualities , such as sometimes develop a new â?? chairâ??s text â?쳌 again , with no reporting of color , size , texture / flavor ( for foods ) , durability , time to maturity , the discussions , thought processes , and other inputs . and other characteristics ) are often more important for genetic 50 ï쳌£ ï쳌¢ ï쳌¤ Articles ï?? ï?? . ï?? , ï?? , and ï?? ; ï?? ï?? . ï?? ; ï?? ï?? . ï?? and ï?? ; ï?? ï?? . ï?? and ï?? ; ï?? ï?? . ï?? and research or utilization . ï?? ; and ï?? ï?? . ï?? . 37 These references are found only in the ï?? ï?? th clause of the preamble 51 The science of molecular genetics , and the practical issues of its and Arts . ï?? ( a ) and ( b ) ( ex situ conservation ) of the ï쳌£ ï쳌¢ ï쳌¤ ( http : use in commercial application , were incompletely understood in / / www.biodiv.org ) . the negotiations . It is recognized that genetic modification technol - 38 â?? [ G ] enetic resources collected from in - situ sources , including ogy is only one of the many ways in which biological material is populations of both wild and domesticated species , or taken from used as a template for the development of commercial products or ex - situ sources , which may or may not have originated in that other value . The questions of how â?? genetic resource â?쳌 concepts ap - country . â?쳌 ï쳌£ ï쳌¢ ï쳌¤ Art . ï?? ( http : / / www.biodiv.org ) . ply to these nongenetic uses are highly complex and not resolved . 39 Another relevant component of â?? unjust enrichment â?쳌 is the fact that The paragraph to which this footnote is appended describes what a country may have made a historical contribution to the asset that was considered in the negotiations , and not what is actually hap - is being exploited , which should in fairness be compensated . In pening in practice â?? then or now . The ï쳌¡ ï쳌¢ ï쳌³ Project is in the process the case of genetic resources , this contribution may have been the of developing further legal and advisory documents addressing improvement of traditional plant ( or animal ) varieties , or a long these issues . history of nonexploitative behavior , which resulted in the continued 52 The ownership of plants is often delimited by geographical bound - existence of an ecosystem or species that has died out in industrial - aries , this kind of right is known in various countries by various ized or overexploitive countries . names , including â?? easement â?쳌 , â?? profit a prendre â?쳌 , and other terms . 40 Requirements about undertaking activities in countries of origin Many of these terms are used in different countries to represent ( Article ï?? ) ; and protecting traditional and indigenous rights different kinds of rights . ( Articles ï?? ( j ) and ï?? ï?? ( c ) ) , for example . The ï쳌¡ ï쳌¢ ï쳌³ Project will be 53 Although difficult , this challenge does not appear impossible . Note undertaking additional research on the general equity requirements of the ï쳌£ ï쳌¢ ï쳌¤ , and how they relate to the ï쳌¡ ï쳌¢ ï쳌³ regime , with publication that the current system for protecting and marketing software also ï?? ï?? ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? ï?? : L ï쳌¥ ï쳌§ ï쳌¡ ï쳌¬ I ï쳌³ ï쳌³ ï쳌µ ï쳌¥ ï쳌³ ï쳌¡ ï쳌® ï쳌¤ ï쳌´ ï쳌¨ ï쳌¥ I ï쳌® ï쳌´ ï쳌¥ ï쳌² ï쳌® ï쳌¡ ï쳌´ ï쳌© ï쳌¯ ï쳌® ï쳌¡ ï쳌¬ R ï쳌¥ ï쳌§ ï쳌© ï쳌­ ï쳌¥ required the creation of a new and consistent approach . Other they put their shareholders â?? interests first â?? that is , that they do not current challenges of this type include the digital downloading of allow other nonprimary objectives to interfere with their primary recorded music and the posting and use of online - but - proprietary responsibility to make money for their shareholders . As a result , it information . is not reasonable or possible simply to expect corporate , com - mercial , or industrial entities to take actions voluntarily that would 54 â?? Principles on access to genetic resources and benefit - sharing either empower the parties with which they are negotiating or for participating institutions â?쳌 have been developed and indepen - otherwise diminish the entityâ??s profits from a particular transaction . dently adopted by ï?? ï?? botanical gardens worldwide . The principles This is the basic justification for official governance . are available online at http : / / www.rbgkew.org.uk / conservation / 64 principles.html . In many commercial situations , it is common to keep the contents 55 ( or at least key financial matters ) of particular contracts confiden - University researchers , for example , are among the primary sources tial . These confidentiality clauses often state that the contract will of progress toward new amoebacidal compounds and medicines â?? cease , if the confidentiality requirement is breached . work that is critical for developing countries where amoeba - related 65 illnesses may account for more deaths than ï쳌¡ ï쳌© ï쳌¤ ï쳌³ or cancer . ( M . These fears are not unfounded . For a useful case study of the Merchant , pers . comm . May , ï?? ï?? ï?? ï?? ) dangers to bulk commodity providers who are convinced to operate 56 through unregulated commerce , where the market is controlled by Following on the initial work of R ï쳌µ ï쳌© ï쳌º et al . ( ï?? ï?? ï?? ï?? ) , the ï쳌© ï쳌µ ï쳌£ ï쳌® ï쳌¡ ï쳌¢ ï쳌³ a small group of buyers , see S ï쳌£ ï쳌¨ ï쳌¬ ï쳌¯ ï쳌³ ï쳌³ ï쳌¥ ï쳌² ( ï?? ï?? ï?? ï?? ) . Project is commissioning a study of the mechanisms for track - 66 ing gene flows at national and international levels . Publication is ï쳌£ ï쳌¢ ï쳌¤ ï쳌£ ï쳌¯ ï쳌° - ï?? Resolution ï쳌¶ / ï?? ï?? . expected in ï?? ï?? ï?? ï?? . 67 See , e.g . , ï쳌© ï쳌µ ï쳌£ ï쳌® World Conservation Congress Resolution ï?? . ï?? ï?? 57 Many products are not patented , for example . And in a number of â?? International Ombudsman for the Environment â?쳌 ( Amman , ï?? ï?? ï?? ï?? ) . cases , a genetic material or biochemical compound are integral 68 By and large , opposition to this approach related to the goal of parts of the process of creation of a product , but do not appear in eliminating multiple planning and strategy development processes . the product itself . One of the primary advances of the ï쳌£ ï쳌¢ ï쳌¤ ( and the United Nations 58 Patent officials do not currently posses the ability , expertise , and Conference on Environment and Development where the ï쳌£ ï쳌¢ ï쳌¤ was equipment to evaluate the whether it will be necessary to enquire adopted ) was its recognition of the value of integrated planning , into the genetic / biochemical source of any component of a product both as a way of minimizing the costs of multiple internation - or invention being developed . Within industry , the technology ally mandated planning processes and as a way of improving the to determine the species / variety that is the source of a particular manner in which those processes function . A separate ï쳌¡ ï쳌¢ ï쳌³ strategy molecular structure is improving rapidly . It is highly unlikely , seemed to roll back both of these hard - won advances . however , that the equipment necessary for this work will become 68 While legislation is being negotiated , the source of these comments available to developing countries at a price that they can afford , or has asked that his name and national government affiliation should that they will have the capacity individually to watchdog the rel - not be disclosed . When the legislation is adopted ( expected in evant industries to test their products in cases of possible violation . ï?? ï?? ï?? ï?? or ï?? ï?? ï?? ï?? ) , its unique and important characteristics will be well Leif Christiansen , Diversa , presentation at International Workshop publicized , and their relationship to this footnote will be clear . â?? Accessing genetic resources and sharing the benefits : Lessons 70 Estimates of how long this process took depend on whether prior from implementing the Convention on Biological Diversity â?쳌 , unsuccessful rounds of negotiations are included . ï?? ï?? - ï?? ï?? October ï?? ï?? ï?? ï?? , University of California , Davis . See http : 71 / / www.grcp.ucdavis.edu / projects / ï쳌¡ ï쳌¢ ï쳌³ dex.htm . The Kyoto Protocol to the ï쳌¦ ï쳌£ ï쳌£ ï쳌£ was adopted ï?? ï?? March ï?? ï?? ï?? ï?? , but 59 has still not entered into force . Except perhaps to lawyers who practice in the area of commercial 72 transactions . In this connection , it is important to keep in mind that the 60 Cartagena Protocol addresses only a few particular issues relating The author hopes that this hypothetical example will be useful in to the transboundary movement and introduction of ï쳌§ ï쳌­ ï쳌¯ s . The helping the reader to focus on the particular conceptual issue ad - larger issues of biosafety and national policy responses are , as yet , dressed and not be confused by other facts not relevant to the point . not covered ( M ï쳌¡ ï쳌£ ï쳌« ï쳌¥ ï쳌® ï쳌³ ï쳌© ï쳌¥ et al . ï?? ï?? ï?? ï?? ) . 61 It may be that the primary lesson to be learned , however , is that 73 The ï쳌§ ï쳌¬ ï쳌­ ï쳌­ ï쳌£ was formed in February , ï?? ï?? ï?? ï?? , with the Cancun â?? these things take time â?쳌 . Although significantly more has been ac - Declaration . It consists of about a dozen countries that are home to complished in legal terms toward that regime , the ï쳌¦ ï쳌£ ï쳌£ ï쳌£ â?? s â?? mecha - more than ï?? ï?? % of the worldâ??s biodiversity . In addition to ï쳌£ ï쳌¢ ï쳌¤ meet - nisms â?쳌 for creating and operating the market in carbon credits are ings , it has now exerted its influence in ï쳌£ ï쳌© ï쳌´ ï쳌¥ ï쳌³ ï쳌£ ï쳌¯ ï쳌° s , the ï쳌· ï쳌³ ï쳌³ ï쳌¤ , ï쳌· ï쳌´ ï쳌¯ , still not in force or operational . ï쳌· ï쳌© ï쳌° ï쳌¯ , and other meetings . 62 As noted above , the commitments of the Parties are already bind - 74 Economic valuation of biological diversity is a debate that has been ing and mandatory . ongoing for many years and remains active . At present , no agreed 63 In this connection , it should be noted that such abuse is not the mechanism for valuing species within ecosystems has been found . fault of the commercial or industrial entities . Rather , it is an Once that is agreed , however , it will still be necessary to engage outgrowth of the basic nature of such entities . They are created in further economic discussion regarding how a species â?? â?? genetic to engage in commerce and to earn profits . They are not created resources â?쳌 can be valued . for charitable purposes or the conservation of the environment . In 75 many countries , they are specifically required to demonstrate that An Appendix II species under ï쳌£ ï쳌© ï쳌´ ï쳌¥ ï쳌³ ( http : / / cites.org / ) . ï?? ï?? ï?? ï?? ï?? ï?? 13 Conclusions , Lessons , and Recommendations Santiago Carrizosa Eleven years have passed since the Convention on scenarios where the providers and users of genetic re - sources range from holders of traditional knowledge such Biological Diversity ( ï쳌£ ï쳌¢ ï쳌¤ ) came into force and only ï?? ï?? % as indigenous communities to high - end users that include of the ï?? ï?? countries analyzed in this study have developed biotechnology companies . Today , the challenge is to figure some sort of access and benefit - sharing ( ï쳌¡ ï쳌¢ ï쳌³ ) policy or law out a participatory strategy to develop , implement , monitor , and all of these countries are still perfecting those regula - evaluate , and enforce ï쳌¡ ï쳌¢ ï쳌³ policies for genetic , biological , tions ( see Chapter ï?? ) . Furthermore , ï쳌¡ ï쳌¢ ï쳌³ laws and policies and biochemical resources and the information associated of these countries have approved only ï?? ï?? bioprospecting with these resources . The diverse social , economic , ethi - projects between ï?? ï?? ï?? ï?? and July ï?? ï?? ï?? ï?? ( see Chapter ï?? ) . cal , and political implications of these policies demand This record of policy development and implementation the participation of a wide variety of stakeholders that does not necessarily show that countries have been inef - include agriculture research centers , environmental ï쳌® ï쳌§ ï쳌¯ s , ficient , but rather cautious and inexperienced . Before the indigenous and farmer communities , government agencies , ï쳌£ ï쳌¢ ï쳌¤ was signed , most , if not all , of these countries had a biotechnology firms , and universities . permit system to regulate the extraction and management National ï쳌¡ ï쳌¢ ï쳌³ laws and policies presented in this report of biological resources . The transition from these permit are one of the main elements of the future international systems to more comprehensive ï쳌¡ ï쳌¢ ï쳌³ frameworks has run regime on ï쳌¡ ï쳌¢ ï쳌³ . The analysis of these frameworks ( see into obstacles that include finding the economic means Chapters ï?? and ï?? ) illustrates many of the gaps and limita - to develop such frameworks , consolidating the technical tions that will challenge policymakers during the negotia - expertise , and obtaining the much - needed consensus about tions process of the international regime . In addition , it will new and controversial issues raised by the ï쳌£ ï쳌¢ ï쳌¤ . be imperative for policymakers to revisit key ï쳌¡ ï쳌¢ ï쳌³ concepts In any case , implementing these ï쳌¡ ï쳌¢ ï쳌³ laws and bio - and assumptions ( see Chapter ï?? ï?? ) in order to bring clarity prospecting agreements have provided valuable lessons to the process . ( see Chapter ï?? ) about the limitations , ambiguities , and implications of these policies that operate in complex Complex Issues ï쳌¡ ï쳌¢ ï쳌³ and ï쳌© ï쳌° ï쳌² policies address the question of how to pursue ties , and uncertainties for various socioeconomic groups ( G ï쳌² ï쳌¥ ï쳌¡ ï쳌¶ ï쳌¥ ï쳌³ ï?? ï?? ï?? ï?? , B ï쳌² ï쳌µ ï쳌³ ï쳌¨ and S ï쳌´ ï쳌¡ ï쳌¢ ï쳌© ï쳌® ï쳌³ ï쳌« ï쳌¹ ï?? ï?? ï?? ï?? , S ï쳌¨ ï쳌© ï쳌¶ ï쳌¡ ï?? ï?? ï?? ï?? , the public good through cures for diseases , highly pro - M ï쳌¯ ï쳌¯ ï쳌® ï쳌¥ ï쳌¹ ï?? ï?? ï?? ï?? ) . More than any other natural resource ductive crops , scientific opportunities , and biodiversity policy , ï쳌¡ ï쳌¢ ï쳌³ policies have been the target of misconcep - conservation , among others ( R ï쳌¥ ï쳌© ï쳌¤ et al . ï?? ï?? ï?? ï?? , S ï쳌· ï쳌¡ ï쳌® ï쳌³ ï쳌¯ ï쳌® tions , politics , and negative publicity . Biopiracy claims , ï?? ï?? ï?? ï?? , R ï쳌¯ ï쳌³ ï쳌¥ ï쳌® ï쳌´ ï쳌¨ ï쳌¡ ï쳌¬ et al ï?? ï?? ï?? ï?? , ï쳌´ ï쳌¥ ï쳌® K ï쳌¡ ï쳌´ ï쳌¥ and L ï쳌¡ ï쳌© ï쳌² ï쳌¤ ï?? ï?? ï?? ï?? ) , poorly defined ownership rights over genetic resources , the but these policies also result in opportunity costs , ambigui - ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ patenting of life , the protection of traditional knowledge , is not a gold mine . Since royalty rates are usually and equity issues have thwarted access initiatives and below ï?? % , contracts have been criticized as being have also contributed to the cancellation of bioprospect - inequitable benefit - sharing mechanisms . However , ing projects in countries such as Mexico ( see Chapters ï?? depending on the industry , it can generate signifi - and ï?? ) . Bioprospecting projects also remain the focus of cant monetary and nonmonetary incentives for local fierce and intensive criticism by advocate groups that have capacity building and technological development great influence among indigenous organizations , govern - as demonstrated by the Costa Rican experience ment actors , and environmental groups worldwide ( see ( see Chapter ï?? ) . Chapters ï?? and ï?? ) . â?¢ Traditional and sui generis ï쳌© ï쳌° ï쳌² laws and policies , The fact that most of these policies and projects will registers of traditional knowledge , ï쳌° ï쳌© ï쳌£ require - indulge or deprive specific stakeholders tends to mobilize ments , certificates of origin or legal provenance , them to shape the policies in their interests . Taking into and benefit - sharing agreements are some of the account the importance of this debate , Chapter ï?? presented mechanisms used by most countries to protect a comparative analysis of eight key issues ( i.e . , owner - scientific and the traditional knowledge at differ - ship , scope , access procedure , prior informed consent ent levels . ( ï쳌° ï쳌© ï쳌£ ) , benefit sharing and compensation mechanisms , â?¢ Patenting of life is a very controversial issue debated intellectual property rights ( ï쳌© ï쳌° ï쳌² s ) and the protection of at national and international forums . It is interesting traditional knowledge , in situ biodiversity conservation to note that in some countries , such as Costa Rica , and sustainable use , and monitoring and enforcement ) . In î?? î?? î?¬ policies initially excluded genes , microorgan - spite of the novel and experimental nature of most of these isms , plants , and animals from patenting , however , issues , it is possible to distill the following set of conclu - the exclusions have been repealed years later by sions and recommendations for improving ï쳌¡ ï쳌¢ ï쳌³ regimes , to amendments to national patent laws . Furthermore , help countries to develop more effective approaches , and many countries argue that the Agreement on Trade to alert policymakers about the challenges they will face Related Aspects of Intellectual Property Rights while negotiating the international regime on ï쳌¡ ï쳌¢ ï쳌³ . ( ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ ) must be revised to prohibit the patenting of plants , animals , and microorganisms . This posi - Conclusions tion has support among several developing countries ( e.g . , the African Group ) and many grassroots , in - â?¢ The scope of most ï쳌¡ ï쳌¢ ï쳌³ policies is very broad and digenous , and some environmental groups . comprehensive . This has impaired the effective â?¢ Almost all ï쳌¡ ï쳌¢ ï쳌³ policies address the need to promote and efficient implementation of these policies . The the conservation of biological diversity and impose scope covers nonhuman genetic ( ï쳌¤ ï쳌® ï쳌¡ and ï쳌² ï쳌® ï쳌¡ ) , some ecological restrictions and impact mitigation biological ( specimens and parts of specimens ) , and requirements on bioprospecting . According to the biochemical ( molecules , combination of molecules , Costa Rican experience , which has the longest re - and extracts ) resources found in in situ and ex situ cord of implementation of bioprospecting projects conditions . in the world , bioprospecting has not been a signifi - â?¢ Since the main implication of Article ï?? ï?? ( ï?? ) of the cant source of funding for biodiversity conservation ï쳌£ ï쳌¢ ï쳌¤ is that ex situ genetic resources collected before when compared to other sources of funding ( see the ï쳌£ ï쳌¢ ï쳌¤ entered into force are not covered by it , pre - Chapter ï?? ) . ï쳌£ ï쳌¢ ï쳌¤ ex situ collections should not be covered by the â?¢ Monitoring bioprospecting activities and the right - scope of ï쳌¡ ï쳌¢ ï쳌³ policies . However , in practice , most ful use of samples collected for commercial and ï쳌¡ ï쳌¢ ï쳌³ policies cover these collections . In any case , noncommercial purposes is a difficult , expensive , access to pre - or post - ï쳌£ ï쳌¢ ï쳌¤ ex situ collections has not and resource consuming task . No Pacific Rim coun - been clearly defined by the ï쳌¡ ï쳌¢ ï쳌³ polices presented in try has in place either a national or an international this report . Ownership of these collections is still monitoring system . Once samples leave the country controversial . The scope of most ï쳌¡ ï쳌¢ ï쳌³ policies also it is very difficult to follow their use and the ex - applies to traditional knowledge associated with change of information about them . Some countries these resources , but it excludes traditional uses of such as Nicaragua might require bioprospectors to these resources by indigenous and local communi - pay for monitoring and evaluation procedures and ties in accordance with their traditional practices . other countries such as the Philippines and Peru â?¢ Under the ï쳌£ ï쳌¢ ï쳌¤ , bilateral agreements have formalized might require purchasing a compliance or ecological the negotiation of benefits derived from the use of bond . genetic , biological , or biochemical resources . Some â?¢ Some national ï쳌¡ ï쳌¢ ï쳌³ and ï쳌© ï쳌° ï쳌² policies propose us - national ï쳌¡ ï쳌¢ ï쳌³ laws and policies have defined criteria ing a certificate of origin or legal provenance to for the minimum benefits ( Costa Rica , Philippines , track the patenting of genetic resources acquired Peru , and Samoa ) that they expect to receive . Policymakers must be reminded that bioprospecting illegally . This measure , however , has limitations . ï?? ï?? ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? ï?? : C ï쳌¯ ï쳌® ï쳌£ ï쳌¬ ï쳌µ ï쳌³ ï쳌© ï쳌¯ ï쳌® ï쳌³ , L ï쳌¥ ï쳌³ ï쳌³ ï쳌¯ ï쳌® ï쳌³ , ï쳌¡ ï쳌® ï쳌¤ R ï쳌¥ ï쳌£ ï쳌¯ ï쳌­ ï쳌­ ï쳌¥ ï쳌® ï쳌¤ ï쳌¡ ï쳌´ ï쳌© ï쳌¯ ï쳌® ï쳌³ For example , patent clerks lack the expertise and access and thus minimize financial and human equipment required to identify genetic resources or resources for both users and providers of genetic biochemicals used for the creation of inventions , un - resources . The scope of the international regime on less the patent applicant discloses this information . ï쳌¡ ï쳌¢ ï쳌³ will also have to be clearly defined and must A certificate or origin or legal provenance has also acknowledge and be consistent with national ï쳌¡ ï쳌¢ ï쳌³ been proposed as a key element of the international policies . Furthermore , the scope of the international regime on ï쳌¡ ï쳌¢ ï쳌³ . regime must be clear about its limitations and the type of activities ( see Chapter ï?? ï?? ) that constitute â?¢ Should States be directly involved in the nego - utilization of genetic , biochemical , and biological tiation of benefit - sharing agreements ? Or should resources . this negotiation be left to the direct providers of genetic resources and traditional knowledge ? The â?¢ ï쳌¡ ï쳌¢ ï쳌³ policies of some countries such as the Philip - issue of State intervention is a complex and con - pines have defined specific access procedures for troversial question in most countries . While some bioprospectors that have noncommercial purposes . commentators demand that the State needs to be di - Some policies also facilitate access to national bio - rectly involved in the negotiation of benefit - sharing prospectors . However , all policies have the same agreements ( see Chapter ï?? ) , others claim that this access procedure for the biotechnology , pharma - practice results in bureaucratic hurdles ( see Chapter ceutical , seed , agrochemical , ornamental , botani - ï?? ) that lead to inefficiencies and high transaction cal medicine , and food industries that use genetic , costs ( see Chapter ï?? ) . biological , and biochemical resources . This cre - ates confusion and high transaction costs among â?¢ The complex nature of ï쳌¡ ï쳌¢ ï쳌³ policies and empirical access applicants . Unlike a modern pharmaceutical data suggest that these policies are likely to be re - company , a small domestic industry that extracts vised , refined , and altered over time . The complex - aromatic oils may not have the economic resources ity of ï쳌¡ ï쳌¢ ï쳌³ issues helps explain why policymakers and other stakeholders do not anticipate the prob - to go through a complex and expensive access pro - lems that almost inevitably arise once policies are cedure . Therefore , it may be appropriate to define enacted . criteria that facilitate access to low - tech and small commercial users of genetic , biological , and bio - chemical resources . Such a differentiated access Recommendations procedure would also mean that countries would â?¢ Defining clear ownership rights over genetic , bio - need less human and financial resources to facilitate logical , and biochemical resources is a condition access . In most ï쳌¡ ï쳌¢ ï쳌³ policies access procedures for to facilitate the development of legitimate ï쳌¡ ï쳌¢ ï쳌³ poli - resources found in ex situ conditions remain a gray cies . While ownership rights over in situ genetic , area due to ownership issues . In all cases , however , biological , and biochemical resources is relatively such access must be for environmentally sound uses clear in many countries reviewed in this report , as mandated by Article ï?? ï?? ( ï?? ) of the ï쳌£ ï쳌¢ ï쳌¤ . these rights still need to be clarified for resources found in ex situ conditions . Some countries such as â?¢ ï쳌° ï쳌© ï쳌£ should be obtained from both national authori - Malaysia also need to clarify ownership of genetic ties and the providers of genetic resources and resources found in indigenous land ( see Chapters traditional knowledge . According to ï쳌¡ ï쳌¢ ï쳌³ laws and ï?? and ï?? ï?? ) . policies reviewed in this report , ï쳌° ï쳌© ï쳌£ from the gov - ernment can be obtained through collecting permits â?¢ Obtaining access has been a long , confusing , or access agreements and ï쳌° ï쳌© ï쳌£ from the providers and frustrating process for many bioprospecting of genetic resources or traditional knowledge can actors that have commercial and noncommercial be obtained through agreements or certificates that goals . In some countries there is confusion about are usually the result of a consultation process . In who regulates access to in situ and ex situ genetic any case , ï쳌° ï쳌© ï쳌£ procedures must be clearly outlined resources . Source countries must define an office in a way that reduces time and transaction costs or focal point to process all access applications . for bioprospectors and these procedures must also â?¢ The broad and comprehensive scope of ï쳌¡ ï쳌¢ ï쳌³ policies be simplified for noncommercial bioprospectors . has caused confusion among users and providers Bioprospectors should be aware about the main of genetic resources about the type of activities cultural , economic , and social characteristics of the that must be regulated . Countries may follow two providers of genetic resources . They should be able courses of action . First , if they decide to adopt a to explain complex and controversial aspects of the comprehensive scope it is important to clarify the research and research implications such as ï쳌© ï쳌° ï쳌² s . range and type of activities that are covered by the â?¢ ï쳌¡ ï쳌¢ ï쳌³ policies of some countries , such as Costa scope of the policy . Second , countries may want Rica , Philippines , Peru , and Samoa , set minimum to define a less ambitious and more concrete scope ( see Chapters ï?? and ï?? ) that is likely to facilitate benefit - sharing standards that must be followed ï?? ï?? ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ by all bioprospectors . However , given the broad of complying with ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ requirements . diversity of domestic and international commercial â?¢ Some countries , such as Chile , have chosen to bioprospecting initiatives that seek access , even ap - develop national biodiversity strategies and action plying a minimum standard across the board to all plans ( designed to implement the ï쳌£ ï쳌¢ ï쳌¤ as a whole ) of these initiatives might not be realistic or fair . If before they complete ï쳌¡ ï쳌¢ ï쳌³ policies . These plans countries choose to develop such standards , they and strategies may provide not only a national should define a range of them to be applied in a legal and political context for the development differentiated manner and depending upon the com - and implementation of ï쳌¡ ï쳌¢ ï쳌³ policies , but may also mercial nature of the bioprospecting activity . raise awareness about key issues and build local capacity and community - based processes that will â?¢ Ensuring the effective protection of traditional facilitate future debates about ï쳌¡ ï쳌¢ ï쳌³ issues . knowledge and preventing the illegal appropria - tion of genetic resources must occur at two levels : â?¢ Developing a regional ï쳌¡ ï쳌¢ ï쳌³ policy or strategy a ) ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ must require patent applicants to disclose may clarify access rules for bioprospectors and the origin of samples , traditional knowledge , and also prevent them from negotiating the best deal ï쳌¡ ï쳌¢ ï쳌³ agreements used for the development of prod - among countries that share common ecosystems ucts that they wish to protect and b ) countries must and species . This was one of the original goals of include similar requirements in national ï쳌¡ ï쳌¢ ï쳌³ and Decision ï?? ï?? ï?? , but national differences in the adop - ï쳌© ï쳌° ï쳌² s policies . More than half of the ï?? ï?? countries tion and implementation processes of the law have examined in this report comply or are in the process interfered with this purpose . Complex Stakeholders Defining the scope of access policies , identifying strategies to society . A few express concern that a bioprospecting to protect traditional knowledge , and ensuring that benefits policy can encourage access to foreign multinationals provide for conservation of biological diversity are just a and the potential loss of benefits and opportunities for few of the most challenging tasks faced by policymakers local scientists . Many , however , support partnerships and ( see Chapter ï?? ) . The great variety of agendas , perspec - collaborative research with foreign organizations as long tives , and opinions regarding these issues pose quite a as this brings opportunities to local researchers . While challenge for anyone seeking endorsement of ï쳌¡ ï쳌¢ ï쳌³ policies some argue that ï쳌¡ ï쳌¢ ï쳌³ policies should differentiate between by all stakeholders . Our research identified a wide range commercial and noncommercial research , others believe of these perspectives from key national and international that making this distinction is difficult task ( see Chapters stakeholders . For example , a common perception among ï?? and ï?? ) . some indigenous and farmers groups and advocate ï쳌® ï쳌§ ï쳌¯ s Some environmental groups from countries such as from countries such as Colombia , Costa Rica , Mexico , the Colombia , Mexico , and Australia advocate for a bio - Philippines , and Australia is that bioprospecting is a new prospecting policy that addresses not only commercial form of colonialism . Many are against commercializing and market - related goals but also environmental protec - traditional knowledge and any form of bioprospecting . tion objectives . They are usually concerned about equity To them traditional knowledge should not be considered issues and a few use the term â?? biopiracy â?쳌 to describe unfair anyoneâ??s property , nor should it be used to divide neigh - and inequitable bioprospecting contracts . Biopiracy is also boring communities that bid for the best deal offered by associated with the stealing of genetic resources , the inad - bioprospectors . Instead , such knowledge should strengthen equate consultation of local communities , and the use of relationships and responsibilities among and within indig - intellectual property rights to obtain monopolies over ge - enous communities . Some also question the efficacy and netic resources and traditional knowledge . Some argue that appropriateness of a contractual approach to protect indig - it may be more valuable to preserve traditional knowledge enous interests and knowledge and to ensure the equitable rather than commercialize it . Others emphasize that society sharing of benefits . Other groups , however , support the at large should benefit from bioprospecting by promoting need to develop national ï쳌¡ ï쳌¢ ï쳌³ policies to fill current gaps biodiversity conservation , economic growth , and human of national laws and protect the interests of indigenous health . Some are concerned about environmental impacts communities ( see Chapters ï?? , ï?? , ï?? , ï?? , and ï?? ) . of bioprospecting activities ( see Chapters ï?? , ï?? , and ï?? ) . Some scientific and biotechnology groups from coun - On the other hand , some policymakers from countries tries such as Costa Rica andAustralia advocate ï쳌¡ ï쳌¢ ï쳌³ policies such as Colombia and Mexico are burdened by pressure that facilitate bioprospecting activities in their countries . from local stakeholders and international commitments They support flexible policies . Policies that do not restrict to implement the mandate of the ï쳌£ ï쳌¢ ï쳌¤ and the ï쳌¦ ï쳌¡ ï쳌¯ research , but that encourage ethical behavior , fair benefit International Treaty on Plant Genetic Resources for Food sharing , and the growth of the local biotechnology industry . and Agriculture ( ï쳌© ï쳌´ ï쳌° ï쳌§ ï쳌² ï쳌¦ ï쳌¡ ) . They usually support com - Many emphasize that the lack of such a policy results in mercially oriented ï쳌¡ ï쳌¢ ï쳌³ policies that attract technology , the loss of opportunities from bioprospecting and benefits foreign investment , and opportunities for local scientists ï?? ï?? ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? ï?? : C ï쳌¯ ï쳌® ï쳌£ ï쳌¬ ï쳌µ ï쳌³ ï쳌© ï쳌¯ ï쳌® ï쳌³ , L ï쳌¥ ï쳌³ ï쳌³ ï쳌¯ ï쳌® ï쳌³ , ï쳌¡ ï쳌® ï쳌¤ R ï쳌¥ ï쳌£ ï쳌¯ ï쳌­ ï쳌­ ï쳌¥ ï쳌® ï쳌¤ ï쳌¡ ï쳌´ ï쳌© ï쳌¯ ï쳌® ï쳌³ and industries . Others are concerned about a political this variety of perspectives , concerns , and agendas is the backlash from indigenous and environmental groups challenge faced by policymakers to ensure legitimate ï쳌¡ ï쳌¢ ï쳌³ caused by decisions to grant access to genetic resources policies as indicated by policy processes carried out in under illegitimate ï쳌¡ ï쳌¢ ï쳌³ policies or inequitable benefit - shar - countries that include Colombia , Costa Rica , Philippines , ing agreements ( see Chapters ï?? and ï?? ) . Bringing together Malaysia , and Australia ( see Chapter ï?? ) . Complex Policymaking and Implementation Scenarios How do policymakers deal with the complexity of ï쳌¡ ï쳌¢ ï쳌³ is - ï쳌£ ï쳌¢ ï쳌¤ are defined by a minority that not always represent sues ? Motivations are as complicated and multiple as are the diverse interests of each country ) . Centralization of the policy objectives . Some policymakers usually complain authority has been used in all societies as a way to im - about the complexity of the issues and users they face . The prove both information flows and the ability to design inability to face this complexity may be responsible for the and implement policies . Centralization can also refer to failure to uphold appropriate standards of equity , respect concentration of power in the hands of : a ) a central national for traditional knowledge , and biodiversity conservation . government rather than states , provinces , or municipalities ; The opposite danger is that the recognition of complexity b ) ministries or departments rather than semi - autonomous sometimes stimulates an overreaction that puts too much authorities or corporations ; c ) local authorities rather than authority in the hands of technicians mistakenly thought to local communities ; and d ) local community elites rather be the experts on complexity ( A ï쳌³ ï쳌£ ï쳌¨ ï쳌¥ ï쳌² and H ï쳌¥ ï쳌¡ ï쳌¬ ï쳌¹ ï?? ï?? ï?? ï?? ) . than the broad spectrum of community members ( A ï쳌³ ï쳌£ ï쳌¨ ï쳌¥ ï쳌² In any case , few things are more difficult for poli - and H ï쳌¥ ï쳌¡ ï쳌¬ ï쳌¹ ï?? ï?? ï?? ï?? ) . A major and well - known problem of cymakers to do than to pursue the development of ï쳌¡ ï쳌¢ ï쳌³ centralization is that technical expertise becomes increas - objectives in complex policymaking and implementation ingly scarce as one moves from the center to the periphery scenarios . The demands of interest groups , self - interest of of a society and this is certainly the case in most of the specialized government and nongovernmental organiza - countries examined in this report ( see Chapter ï?? ) . This tions , the complexity of the interactions within the system , issue is compounded by the fact that ï쳌¡ ï쳌¢ ï쳌³ concepts are and the possibility for unexpected and perverse side effects particularly complex and complexity implies the need are ingredients certainly present in any policymaking and for good information . The uneven quality of information implementation processes , as exemplified by the experi - among stakeholders influences the focus of attention . ences in countries such as Colombia , Australia , Malaysia Centralized expertise also fails to understand and respond and the Philippines ( see Chapter ï?? ) . Furthermore , these to specific local conditions . In other words , the least pow - factors are compounded in other countries examined in erful members of society may be exploited by local elites , this report . These countries have had to face social and they are literally invisible to centralized planners , and na - economic crisis ( Solomon Islands ) , severe shortages of tional elites always find ways of dominating policymaking trained personnel ( Samoa , Cook Islands , Nicaragua ) , ( see Chapter ï?? ) . These least powerful members of society , limited fiscal and technical capacity ( Vietnam ) , fragile particularly in developing countries , include unionized political relationships ( Cook Islands ) , and weak institu - workers , bureaucracies , and farmer and indigenous com - tions ( Laos ) ( see Chapter ï?? ) . In addition to these and other munities.Another circumstance is that centralized agencies economic , political , or social conflicts , these and many usually deal with local notables partly because the local other countries have had to address ï쳌¡ ï쳌¢ ï쳌³ policymaking and elite simply is more articulate and informed than the mass implementation processes in the context of different forms of the population . and levels of centralized and decentralized government Decentralization by itself , however , does not translate auto - structures that influence and determine opportunities for matically into local peopleâ??s participation in the policymak - success or failure . ing and implementation process of ï쳌¡ ï쳌¢ ï쳌³ . Decentralization also requires incentives such as strong local capacity and Centralization vs . Decentralization : effective participation channels . Village cooperatives , labor unions , peasant organizations , and ï쳌® ï쳌§ ï쳌¯ s have be - Finding the Conditions for Participatory come increasingly important channels for the activism Scenarios of indigenous , peasant , and university - educated people . These participatory scenarios facilitate the articulation of In most if not all of the countries examined in this report , a valid counterpoint to centralized governmental input that ï쳌¡ ï쳌¢ ï쳌³ policymaking and implementation was often regarded enriches the debate and contributes to more balanced ï쳌¡ ï쳌¢ ï쳌³ as synonymous with centralized top - down initiatives and policies ( see Chapter ï?? ) . Besides , common sense dictates decision - making was usually monopolized by national that locally originated proposals can be aggregated and governmental organizations ( see Chapters ï?? and ï?? ) . This is shaped to ensure that they are compatible with top - down the heritage of both government regimes ( where the source policymaking approaches such as the ï쳌£ ï쳌¢ ï쳌¤ requirements . of all power is usually found in the capital of the nation ) In addition , in every participatory process , it is impor - and the top - down nature of the ï쳌£ ï쳌¢ ï쳌¤ and its Conference of the Parties ( where the rules of implementation of the tant to be aware of the subtleties of different stakeholders ï?? ï?? ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ that are likely to determine the outcome of the develop - ects take place between a minimum number of parties that ment and implementation process of ï쳌¡ ï쳌¢ ï쳌³ laws and policies . share a common mission and with minimum intervention These include : of bureaucracy and centralized government agencies . In contrast , as demonstrated by the Colombian experience â?¢ Public authorities are not always responsive to public an extensive and centralized bureaucratic process results opinion , especially when government organizations in delays in the negotiation of projects that damage the assume they have sufficient technical capacity and morale and trust of implementers and recipients , thereby expertise as illustrated by the development process hampering successful implementation of ï쳌¡ ï쳌¢ ï쳌³ policy ( see of Decision ï?? ï?? ï?? ( see Chapters ï?? and ï?? ) . Chapters ï?? , ï?? , and ï?? ) . â?¢ Government and nongovernment organizations are not passive recipients of public opinion but Building Local Capacity consciously try to shape , modify , organize , and Policy estimation ( see Chapter ï?? ) and implementation even control it . This is common among all organi - ( see Chapter ï?? ) involve and demand technical expertise zations but mainly among well - funded and strong in ï쳌© ï쳌° ï쳌² issues , biodiversity conservation , business , com - organizations . merce , economics , negotiation , biotechnology , national â?¢ On most ï쳌¡ ï쳌¢ ï쳌³ issues most policymakers and other and international law , social , and cultural issues just to stakeholders do not have an opinion in the sense name a few . The interdisciplinary nature of these issues of having thought about the issue or having a con - was limited if not absent in most countries addressed by our sistent body of information about it . Instead most study ( see Chapter ï?? ) . These issues demand the involve - people are prepared to take a party line or posi - ment of a great variety of stakeholders in development tion rather than invest time and effort analyzing a processes of ï쳌¡ ï쳌¢ ï쳌³ polices . Building a solid national capacity specific issue as exemplified by the development to develop and implement these policies is a requirement process of the Law of Biodiversity of Costa Rica in all the countries analyzed in this report . It is important ( see Chapter ï?? ) . not only to understand the social and economic aspects of the process , but also to learn about the latest technological Nevertheless , as the Costa Rican and Australian experi - developments ( e.g . , combinatorial chemistry or bioinfor - ences indicate , chances of developing and implementing matics ) and the main markets ( e.g . , pharmaceuticals , seed , effective ï쳌¡ ï쳌¢ ï쳌³ policies are likely to increase in a decentral - agrochemicals , or medicinal botany ) that benefit from the ized context where the common denominator is strong use of biological diversity . Countries must be aware of the local capacity and participatory mechanisms coupled with latest scientific developments that fuel these markets ( see strong local government and nongovernment organizations Chapter ï?? ) . This knowledge will contribute to improve the ( see Chapters ï?? and ï?? ) . Evidently , the central government negotiation stance of less industrialized countries . Most has to be part of the development process of ï쳌¡ ï쳌¢ ï쳌³ policies countries also lack negotiators . It is clear that legal and or laws from beginning to end . However , the Costa Rican technical expertise of any multinational is quite superior record of implementation of bioprospecting projects shows compared to the understaffed and overworked negotiators that successful implementation of ï쳌¡ ï쳌¢ ï쳌³ laws and policies will be facilitated when agreement and negotiation of proj - of many of the countries analyzed in this report . Future Scenarios Successful ï쳌¡ ï쳌¢ ï쳌³ policies are usually a reflection of the A hopeful scenario for the next ten years might find that policy process followed for their development . Ideally , at the celebration of the ï?? ï?? thanniversary of the ï쳌£ ï쳌¢ ï쳌¤ , coun - such a process must include the participation of all sec - tries will have found the necessary conditions to facilitate tors of society . ï쳌¡ ï쳌¢ ï쳌³ issues have presented new conceptual , the access to genetic resources and the equitable sharing of political , and operational challenges to stakeholders . The benefits derived from them . Bioprospecting will be a sig - essential role of policy experts and facilitators in explain - nificant source of income for local communities that in turn ing the multiple dimensions and implications of ï쳌¡ ï쳌¢ ï쳌³ will be able to invest a percentage in the conservation of the policies is certainly needed in all the countries that are habitats from which samples were collected . ï쳌¡ ï쳌¢ ï쳌³ policies attempting to develop and implement the ï쳌£ ï쳌¢ ï쳌¤ . To actually will no longer be perceived as a barrier for academic and work once established , the ï쳌¡ ï쳌¢ ï쳌³ policy must have the broad scientific noncommercial research . The concept of biopi - support of all relevant sectors of government and society ; racy will no longer be associated with inequitable benefit - fit within the countryâ??s larger strategy for conserving and sharing agreements and large multinationals . Instead these sustainably using biological diversity ; and be supported by firms will be part of a voluntary international network of decentralized government and nongovernment processes â?? biomonitors â?쳌 . These biomonitors , assuming they have and capabilities sufficient to implement it ( M ï쳌µ ï쳌§ ï쳌¡ ï쳌¢ ï쳌¥ et al . the right incentives , will be the recipients and users of ï?? ï?? ï?? ï?? ) . Building local capacity to improve policy initia - genetic resources and biochemical compounds , they will tion and estimation is a priority for most of the countries ensure that these samples include basic information about reviewed in this study . their source country , fair benefit - sharing agreements , and ï?? ï?? ï?? ï?? ï?? ï?? C ï쳌¨ ï쳌¡ ï쳌° ï쳌´ ï쳌¥ ï쳌² ï?? ï?? : C ï쳌¯ ï쳌® ï쳌£ ï쳌¬ ï쳌µ ï쳌³ ï쳌© ï쳌¯ ï쳌® ï쳌³ , L ï쳌¥ ï쳌³ ï쳌³ ï쳌¯ ï쳌® ï쳌³ , ï쳌¡ ï쳌® ï쳌¤ R ï쳌¥ ï쳌£ ï쳌¯ ï쳌­ ï쳌­ ï쳌¥ ï쳌® ï쳌¤ ï쳌¡ ï쳌´ ï쳌© ï쳌¯ ï쳌® ï쳌³ whether traditional knowledge was used for the collec - chain of improvements and obligations will certainly be a logistical nightmare . tion of samples . This information will be reported to an The International Regime on ï쳌¡ ï쳌¢ ï쳌³ ( see Chapter ï?? ï?? and international clearinghouse mechanism that will report to Appendix ï?? ) will most likely include a mix of voluntary the source country of genetic resources and traditional and mandatory components that will continue to rely on knowledge . Unfortunately , this optimistic and naïve ac - contracts as a primary mechanism for ï쳌¡ ï쳌¢ ï쳌³ . Given biopiracy count of events is quite unlikely . concerns , a key discussion in the negotiation will probably Instead , in the next ten years countries and biopros - revolve around the need for an international monitoring pectors will probably continue to experience many of the mechanism or certification system for samples and bio - policy development and implementation obstacles , limita - prospecting projects . ï쳌´ ï쳌² ï쳌© ï쳌° ï쳌³ may have to be amended to tions , and problems described in this report ( see Chapters include requirements to disclose the source of samples , ï?? and ï?? ) . Many will have completed their ï쳌¡ ï쳌¢ ï쳌³ policies , traditional knowledge , and nonconfidential terms of ben - but most will still be fine - tuning key provisions . Some efit - sharing agreements when products and processes are countries will still be looking for financial assistance and patented . technical expertise to complete ï쳌¡ ï쳌¢ ï쳌³ policies . It is hoped The ï?? ï?? ï?? ï?? Bonn Guidelines on ï쳌¡ ï쳌¢ ï쳌³ adopted by the that most ownership rights of in situ and ex situ genetic Sixth Conference of the Parties of the ï쳌£ ï쳌¢ ï쳌¤ will continue resources will have been clarified . Under the ï쳌¦ ï쳌¡ ï쳌¯ ï쳌© ï쳌´ ï쳌° ï쳌§ ï쳌² ï쳌¦ ï쳌¡ , guiding countries embarked on the development of ï쳌¡ ï쳌¢ ï쳌³ germplasm exchanged by participants in the multilateral frameworks . However , governments and bioprospecting system will not be entitled to any ï쳌© ï쳌° ï쳌² protection , but some groups will continue facing controversial issues such as will argue that isolated genes should be given such pro - the patenting of life , access to traditional knowledge , and tection . Patented and marketed products derived from the the perception that all benefit - sharing agreements are not germplasm ( exchanged under the rules of the multilateral equitable . These issues will continue to control the devel - system ) will have to pay a sum of money to an interna - opment and implementation of national ï쳌¡ ï쳌¢ ï쳌³ frameworks . tional fund of the ï쳌¦ ï쳌¡ ï쳌¯ . The size , terms , and fairness of Developing and implementing national ï쳌¡ ï쳌¢ ï쳌³ laws and poli - such a payment will certainly be a key issue of debate . cies will continue to be a slow process in which multiple Patented products that are not commercialized will not sectors of society with different interests , agendas , views , have to share economic benefits but new products derived and backgrounds must and will continue playing a role . from them that are patented and commercialized will have to contribute financially . Monitoring and enforcing this References A ï쳌³ ï쳌£ ï쳌¨ ï쳌¥ ï쳌² W . and R . H ï쳌¥ ï쳌¡ ï쳌¬ ï쳌¹ . ï?? ï?? ï?? ï?? . Natural resource policymaking and C . J ï쳌µ ï쳌­ ï쳌¡ ( eds . ) Biodiversity prospecting : Using in developing countries . Duke University Press , ï쳌® ï쳌£ ï쳌µ ï쳌³ ï쳌¡ . genetic resources for sustainable development . World Resources Institute , ï쳌µ ï쳌³ ï쳌¡ . B ï쳌² ï쳌µ ï쳌³ ï쳌¨ S.B . and D . S ï쳌´ ï쳌¡ ï쳌¢ ï쳌© ï쳌® ï쳌³ ï쳌« ï쳌¹ ( eds . ) ï?? ï?? ï?? ï?? . Valuing local knowledge : Indigenous people and intellectual property R ï쳌¯ ï쳌³ ï쳌¥ ï쳌® ï쳌´ ï쳌¨ ï쳌¡ ï쳌¬ J.P . , D . B ï쳌¥ ï쳌£ ï쳌« , A . B ï쳌¨ ï쳌¡ ï쳌´ , J . B ï쳌© ï쳌³ ï쳌· ï쳌¡ ï쳌³ , L . B ï쳌² ï쳌¡ ï쳌¤ ï쳌¹ , rights . Island Press . ï쳌µ ï쳌³ ï쳌¡ . K . B ï쳌² ï쳌© ï쳌¤ ï쳌¢ ï쳌¯ ï쳌¡ ï쳌² ï쳌¤ , S . C ï쳌¯ ï쳌¬ ï쳌¬ ï쳌© ï쳌® ï쳌³ , G . C ï쳌² ï쳌¡ ï쳌§ ï쳌§ , J . E ï쳌¤ ï쳌· ï쳌¡ ï쳌² ï쳌¤ ï쳌³ , A . F ï쳌¡ ï쳌© ï쳌² ï쳌¦ ï쳌© ï쳌¥ ï쳌¬ ï쳌¤ , M . G ï쳌¯ ï쳌´ ï쳌´ ï쳌¬ ï쳌© ï쳌¥ ï쳌¢ , L.A . G ï쳌³ ï쳌£ ï쳌¨ ï쳌· ï쳌© ï쳌® ï쳌¤ , Y . H ï쳌¡ ï쳌¬ ï쳌¬ ï쳌¯ ï쳌£ ï쳌« , G ï쳌² ï쳌¥ ï쳌¡ ï쳌¶ ï쳌¥ ï쳌³ T . ( ed . ) ï?? ï?? ï?? ï?? . Intellectual property rights for R . H ï쳌¡ ï쳌· ï쳌« ï쳌³ , R . H ï쳌¥ ï쳌§ ï쳌¹ ï쳌¥ ï쳌¬ ï쳌© , G . J ï쳌¯ ï쳌¨ ï쳌® ï쳌³ ï쳌¯ ï쳌® , G.T . K ï쳌¥ ï쳌µ ï쳌³ ï쳌£ ï쳌¨ , E.E . indigenous peoples : A source book . Society for Applied L ï쳌¹ ï쳌¯ ï쳌® ï쳌³ , R . M ï쳌© ï쳌¬ ï쳌¬ ï쳌¥ ï쳌² , J . R ï쳌¯ ï쳌¤ ï쳌­ ï쳌¡ ï쳌® , J . R ï쳌¯ ï쳌³ ï쳌« ï쳌¯ ï쳌³ ï쳌« ï쳌© , and D . Anthropology , Oklahoma City , ï쳌¯ ï쳌« ï쳌µ ï쳌³ ï쳌¡ . S ï쳌© ï쳌¥ ï쳌§ ï쳌¥ ï쳌¬ - C ï쳌¡ ï쳌µ ï쳌³ ï쳌¥ ï쳌¹ . ï?? ï?? ï?? ï?? . Combining high risk science with M ï쳌¯ ï쳌¯ ï쳌® ï쳌¥ ï쳌¹ P.R . ï?? ï?? ï?? ï?? . Why we call it biopiracy . p . ï?? ï?? â?? ï?? ï?? . in H . ambitious social and economic goals . Pharmaceutical S ï쳌¶ ï쳌¡ ï쳌² ï쳌³ ï쳌´ ï쳌¡ ï쳌¤ and S.S . D ï쳌¨ ï쳌© ï쳌¬ ï쳌¬ ï쳌© ï쳌¯ ï쳌® ( eds . ) Responding to bio - Biology ï?? ï?? : ï?? â?? ï?? ï?? . prospecting : From biodiversity in the south to medicines S ï쳌¨ ï쳌© ï쳌¶ ï쳌¡ V . ï?? ï?? ï?? ï?? . Biopiracy : The plunder of nature and knowl - in the north . Spartacus Forlag . Oslo , Norway . edge . South End Press , Boston , ï쳌­ ï쳌¡ ï쳌µ ï쳌³ ï쳌¡ . M ï쳌µ ï쳌§ ï쳌¡ ï쳌¢ ï쳌¥ J . , C.V . B ï쳌¡ ï쳌² ï쳌¢ ï쳌¥ ï쳌² , H . G ï쳌µ ï쳌¤ ï쳌² ï쳌µ ï쳌® , L . G ï쳌¬ ï쳌¯ ï쳌· ï쳌« ï쳌¡ , and S ï쳌· ï쳌¡ ï쳌® ï쳌³ ï쳌¯ ï쳌® T . ( ed . ) ï?? ï?? ï?? ï?? . Intellectual property rights and biodi - A . L ï쳌¡ V ï쳌© ï?± ï쳌¡ ( eds . ) ï?? ï?? ï?? ï?? . Access to genetic resources : versity conservation : An interdisciplinary analysis of the Strategies for sharing benefits . ï쳌¡ ï쳌£ ï쳌´ ï쳌³ Press , ï쳌· ï쳌² ï쳌© , ï쳌¥ ï쳌¬ ï쳌£ - values of medicinal plants . Cambridge University Press , ï쳌© ï쳌µ ï쳌£ ï쳌® , Nairobi , Kenya . Cambridge ï쳌µ ï쳌« . R ï쳌¥ ï쳌© ï쳌¤ W.V . , S.A . L ï쳌¡ ï쳌© ï쳌² ï쳌¤ , R . G ï?¡ ï쳌­ ï쳌¥ ï쳌º , A . S ï쳌© ï쳌´ ï쳌´ ï쳌¥ ï쳌® ï쳌¦ ï쳌¥ ï쳌¬ ï쳌¤ , D.H . ï쳌´ ï쳌¥ ï쳌® K ï쳌¡ ï쳌´ ï쳌¥ T.K . and S.A . L ï쳌¡ ï쳌© ï쳌² ï쳌¤ . ï?? ï?? ï?? ï?? . The commercial use J ï쳌¡ ï쳌® ï쳌º ï쳌¥ ï쳌® , M.G . G ï쳌¯ ï쳌¬ ï쳌¬ ï쳌© ï쳌® , and C . J ï쳌µ ï쳌­ ï쳌¡ . ï?? ï?? ï?? ï?? . A new lease of biodiversity : Access to genetic resources and benefit - on life . p . ï?? â?? ï?? ï?? in W.V . R ï쳌¥ ï쳌© ï쳌¤ , S.A . L ï쳌¡ ï쳌© ï쳌² ï쳌¤ , C.A . M ï쳌¥ ï쳌¹ ï쳌¥ ï쳌² , R . G ï?¡ ï쳌­ ï쳌¥ ï쳌º , A . S ï쳌© ï쳌´ ï쳌´ ï쳌¥ ï쳌® ï쳌¦ ï쳌¥ ï쳌¬ ï쳌¤ , D.H . J ï쳌¡ ï쳌® ï쳌º ï쳌¥ ï쳌® , M.G . G ï쳌¯ ï쳌¬ ï쳌¬ ï쳌© ï쳌® , sharing . Earthscan . London , ï쳌µ ï쳌« . ï?? ï?? ï?? ï?? ï?? ï?? A1 Appendix 1 : Conclusions from an International Workshop â?? Accessing Genetic Resources and Sharing the Benefits : Lessons from Implementing the Convention on Biological Diversity â?쳌 Held at the University of California , Davis USA on ued work on the Bonn Guidelines on î?? î?? î?¬ as an input for ï?? ï?? â?? ï?? ï?? October ï?? ï?? ï?? ï?? . Workshop participants discussed countries developing î?? î?? î?¬ policies and ( b ) the negotiation of preliminary results of the findings presented in this the development of an international regime to promote the report . Information about the status of î?? î?? î?¬ laws and fair and equitable sharing of benefits derived from the use policies and bioprospecting projects in the Pacific Rim of genetic resources . Only a limited number of countries countries that signed the î?? î?? î?? was updated until July ï?? ï?? ï?? ï?? . have developed and implemented î?? î?? î?¬ policies and there The workshop also provided an opportunity to define the has been a slowing of the flow of genetic resources and main elements and gaps of the existing international sys - reciprocal benefits between countries . tem of î?? î?? î?¬ governance , the main elements of the future These are the main conclusions reached during the work - international regime on î?? î?? î?¬ , and measures that might be shop : taken by the international community to enhance effec - tive international governance . Forty - five experts on î?? î?? î?¬ Main elements of the existing international system of issues from seventeen Pacific Rim countries , multilateral ABS governance organizations involved in î?? î?? î?? implementation , î?? î?? î?¡ s with â?¢ Hard law elements ( î?? î?? î?? , î?® î?« î?? î?© î?¬ , International î?? î?? î?? expertise , collections - based organizations , industry , Treaty on Plant Genetic Resources for Food and 1 and academia participated . Agriculture , international phytosanitary laws , regional and national î?? î?? î?¬ , î?? î?© î?« , and traditional Background knowledge laws and policies ) . In ï?? ï?? ï?? ï?? , the Convention on Biological Diversity ( î?? î?? î?? ) â?¢ Soft law elements ( Bonn Guidelines , national bio - provided a mandate for countries to develop national ge - diversity strategies and action plans , and regional netic resources access and benefit - sharing ( î?? î?? î?¬ ) policies . policies , such as Organization ofAfrican Unity î?? î?? î?¬ In the last ten years , however , countries have encountered Model Law ) . multiple obstacles in developing such policies . Further â?¢ Codes of Conduct : Professional societies ( such motivation for developing national î?? î?? î?¬ policies was pro - as the International Society for Ethnobiology ) , vided by the ï?? ï?? ï?? ï?? Bonn Guidelines on Access to Genetic institutional groups ( such as botanical gardens ) , Resources and Fair and Equitable Sharing of the Benefits and private sector companies have adopted codes Arising out of their Utilization . In addition , the Plan of of conduct or ethics that provide guidelines about Implementation that came out of the ï?? ï?? ï?? ï?? Johannesburg the collection of samples and traditional knowledge World Summit on Sustainable Development recommended ( a ) promotion of the wide implementation of and contin - and benefit - sharing criteria . ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ Gaps in the existing international system of ABS provisions , however , it is widely accepted that the courts should be only a final recourse . governance â?¢ There is a shortage of information gathering , â?¢ Many countries are struggling to develop national exchange , and dissemination mechanisms , and a î?? î?? î?¬ laws and policies . Lack of technical expertise , need to enhance the capacity and scope of the CBD budgetary constraints , weak government structures clearinghouse role . and political support , local social conflict , and con - flict over ownership of genetic resources are some Main elements of the future international regime on of the factors that have prevented the development ABS of these laws and policies . In the Pacific Rim region â?¢ An international regime will continue to include ï?? ï?? countries have signed the î?? î?? î?? . Only ï?? ï?? % of elements of both soft and hard law , and may in - these countries have developed a national î?? î?? î?¬ law volve implementation of the î?? î?? î?? , strengthening of or policy , ï?? ï?? % of these countries are in the process the Bonn guidelines , and development of provider of developing these laws and policies , and ï?? ï?? % and user measures and international arbitration are not engaged in any systematic process leading systems . to the development of these î?? î?? î?¬ frameworks ( last update July ï?? ï?? ï?? ï?? ) . Measures that might be taken by the international com - â?¢ Implementation of î?? î?? î?¬ policies and laws has been munity to enhance effective international governance relatively poor all over the world . In the Pacific Rim â?¢ User measures such as disclosure of origin , vol - region , national î?? î?? î?¬ laws in Costa Rica , Mexico , untary certification schemes , and adoption of in - the Philippines , Samoa , and the United States ( not centives and other measures to secure technology a î?? î?? î?? member ) have been invoked to facilitate transfer and import / export and transport regulations access to a total of ï?? ï?? bioprospecting projects might promote compliance with î?? î?? î?¬ policies and between ï?? ï?? ï?? ï?? and July ï?? ï?? ï?? ï?? ( other projects have help to ensure the equitable sharing of benefits and been implemented under bilateral î?? î?? î?¬ agreements ) . an increase in transfer of technology . Issues identified with the slow implementation of â?¢ Components of national î?? î?? î?¬ policies designed to national laws include î?© î?? î?? conflicts , lengthy and attract researchers ( including both academic and overly complex application procedures , ambigui - corporate bioprospectors ) to study biodiversity ties in the scope of î?? î?? î?¬ frameworks , inadequate could be an effective means to counter the global biodiversity conservation incentives , and variation trend of declining bioprospecting efforts and in - in the expertise on these issues among the indi - crease opportunities for benefit - sharing , advance - viduals assigned the responsibility for carrying ment of science , and furthering our understanding out the development of î?? î?? î?¬ policies from nation of biodiversity . to nation . â?¢ Development of an internationally recognized â?¢ Thereisagapbetweenexpectationsofwhatbiopros - system to document the flow of genetic resources , pecting might deliver and the reality of what it can including where appropriate a means to provide deliver . For some persons , the issue is that as yet evidence of î?© î?? î?? , has an important part to play in there are no clear guidelines on what amounts to consolidation of an effective system of international equitable benefit sharing ; there is an excessive fo - î?? î?? î?¬ governance . The use of the terms certificates cus on monetary benefits ; and technology transfer of origin , source , and provenance have different is neither well defined and understood nor well political and practical implications . Studies to linked to genetic resources access and utilization ; clarify these concepts would be useful . For others , however , the issue is an excessive focus â?¢ The transfer of samples to third parties should not on nonmonetary benefits and technology transfer be carried out except to the extent authorized by thereby obfuscating the crux of the problem : unre - the countries of origin or the authorized ex situ alistically low royalty rates that are entertained in collection that provided the sample . negotiations only because of rent - seeking behavior â?¢ Transfer of technology is one of the principal forms by authorities in the source country . of nonmonetary benefit sharing provided for in the â?¢ There is a wide perception that the î?? î?? î?? has not led î?? î?? î?? and is a crucial component of î?? î?? î?¬ . It would to any significant increase in technology transfer , be useful if the î?? î?? î?? could initiate gathering of in - one of the pillars of the î?? î?? î?? â?? s î?? î?? î?¬ provisions . formation and analysis of these questions : Where â?¢ Knowledge of the processes of science and dis - do genetic resource - related technologies occur and covery in biotechnology , of intellectual property , where have they been transferred ? ; What is the ex - and of market - established agreement ( or contract ) tent of recipient capacity to use and further develop terms is fragmentary . such technologies ? ; Where has transfer been sus - â?¢ There is an absence of compliance and verification tainable and where not ? ; and What are the reasons mechanisms to monitor and enforce the î?? î?? î?? â?? s î?? î?? î?¬ for success or failure in transfer of technologies ? ï?? ï?? ï?? ï?? ï?? ï?? A ï쳌° ï쳌° ï쳌¥ ï쳌® ï쳌¤ ï쳌© ï쳌¸ ï?? with the î?? î?? î?? , as well as at regional and national â?¢ It is important to explore the possibility of develop - ing guidelines for technology transfer in the context levels , offers an interesting possibility for develop - of articles ï?? ï?? and ï?? ï?? of the î?? î?? î?? . One approach ment of alternative dispute resolution mechanisms . meriting consideration would be to have the î?? î?? î?? An ombudsman office at the level of î?? î?? î?? may be include within its program of work the development linked to a linked series of regional structures for of guidelines on technology transfer . monitoring compliance with the î?? î?? î?? and Bonn Guidelines in î?? î?? î?¬ agreements . â?¢ An ombudsman or complaints authority associated Endnotes 1 A roster of workshop particpants is available at î?° î?« î?? : http : / / www.grcp.ucdavis.edu / projects / ABSdex.htm . ï?? ï?? ï?? ï?? ï?? ï?? A2 Appendix 2 . Biographical Sketches of Authors and Editors and conservation of crop genetic resources in cradle ar - Paz J . Benavidez II eas of domestication as well as on farmers â?? rights . Brush Paz J . Benavidez II , a lawyer specializing in environment served as Program Director for Anthropology at the and natural resources issues , received her B.S . of Laws National Science Foundation and Senior Scientist at the from the University of the Philippines in ï?? ï?? ï?? ï?? . Atty . International Plant Genetic Resources Institute . His cur - Benavidez is a legal research consultant of the Committee rent research concerns the relationship between cultural on Ecology , House of Representatives , Republic of the diversity and maize diversity in the Maya highlands of Philippines . She was a legal counsel of the Department of Mexico and the sustainable development of minor tubers in Environment and Natural Resources ( ï쳌¤ ï쳌¥ ï쳌® ï쳌² ) for two years the Cusco area of the Peruvian Andes . His book , Farmers â?? focusing mainly on access to biological and genetic re - Bounty : Locating Crop Diversity in the Contemporary sources and protected area management . Atty . Benavidez World ( Yale ) appeared in ï?? ï?? ï?? ï?? . actively participated in the formulation of the implement - ing rules and regulations of Philippine Executive Order No . Jorge Cabrera - Medaglia ï?? ï?? ï?? and served as one of the legal counsels of the Technical Secretariat of the Inter - agency Committee on Biological Jorge Cabrera - Medaglia , a lawyer specialized in environ - and Genetic Resources ( ï쳌© ï쳌¡ ï쳌£ ï쳌¢ ï쳌§ ï쳌² ) . She was also involved mental , agrarian , and economic law , is currently a legal in the development of a manual on the implementation of adviser to the National Biodiversity Institute of Costa Rica . Philippine executive order on bioprospecting , the draft - His responsibilities at ï쳌© ï쳌® ï쳌¢ io include the negotiation of bio - ing of the model Academic / Commercial research agree - prospecting contracts and material transfer agreements ments and the Code of Conduct for Academic Collectors and ï쳌© ï쳌° ï쳌² policies of the Institution . Mr . Cabrera - Medaglia of Biological and Genetic Resources . She was part of the was member of the National Biodiversity Commission multi - sectoral group that reviewed the said Philippine from ï?? ï?? ï?? ï?? to ï?? ï?? ï?? ï?? and a member of the commission that executive order in ï?? ï?? ï?? ï?? . drafted the biodiversity law . He has also been a government delegate at many ï쳌£ ï쳌¢ ï쳌¤ - related meeting including several Stephen B . Brush Conferences of the Parties . He was also chairman of the ï쳌£ ï쳌¢ ï쳌¤ ad hoc group on access and benefit sharing . He has Stephen Brush is Professor of Human and Community Development at the University of California , Davis . His participated as a consultant in the preparation of draft research focuses on the human ecology of traditional agri - laws and regulations on ï쳌¡ ï쳌¢ ï쳌³ in El Salvador , Nicaragua , cultural systems . He has conducted long - term research in and Bhutan , and regionally in Central America . He has Peru , Mexico , and Turkey on farmer knowledge systems , authored several books and articles . selection , use , and on - farm conservation of crop genetic resources . He has published extensively on the ecology ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ Frontera Sur ( ï?? ï?? ï?? ï?? â?? ï?? ï?? ï?? ï?? ) where he started working on Santiago Carrizosa bioprospecting , traditional knowledge , and intellectual Santiago Carrizosa is a research ecologist with the Genetic property through a project for the Maya communities Resources Conservation Program ( ï쳌§ ï쳌² ï쳌£ ï쳌° ) at the University of the Chiapas highlands . In ï?? ï?? ï?? ï?? he was the National of California ( ï쳌µ ï쳌³ ï쳌¡ ) . Dr . Carrizosa holds a ï쳌¢ . ï쳌³ . in Biology Coordinator of Environmental Policy for ï쳌° ï쳌² ï쳌¯ ï쳌® ï쳌¡ ï쳌´ ï쳌µ ï쳌² ï쳌¡ , from the Universidad de los Andes ( Colombia ) and re - A.C . , his work included the design and analysis of incen - ceived an ï쳌­ . ï쳌³ . and ï쳌° ï쳌¨ . ï쳌¤ . in Renewable Natural Resources tive mechanisms for biodiversity conservation on private from the University of Arizona ( ï쳌µ ï쳌³ ï쳌¡ ) . Dr . Carrizosaâ??s lands . Mr . Fernández - Ugalde was the Mexican repre - research interests are on the relationships among the sentative to the Panel of Experts on Access to Genetic Convention on Biological Diversity , national laws and Resources and Benefit Sharing of the Convention on policies that regulate access to genetic resources , and the Biological Diversity . . exchange of genetic resources between countries . His inter - ests extend to the impact of these international and national Paola Ferreira - Miani laws on local biodiversity conservation and sustainable Paola Ferreira - Miani , a biodiversity researcher and con - use initiatives . Dr . Carrizosa has written extensively on a sultant for Latin America , received a B.S . in Biology at wide variety of issues that include biodiversity conserva - the Universidad de los Andes ( Colombia ) and an M.S . in tion and sustainable use strategies in Colombia , financial technology and Policy at the Massachusetts Institute of incentives for forest plantations , bioprospecting models Technology ( ï쳌µ ï쳌³ ï쳌¡ ) . Mrs . Ferreiraâ??s main interest is the de - in Chile and Argentina , and biodiversity monitoring and velopment of renewable natural resource policies , includ - evaluation indicators . In ï?? ï?? ï?? ï?? , he also published a book ing biodiversity in developing countries . She led the devel - titled â?? Bioprospecting and access to genetic resources â?쳌 opment of Colombiaâ??s National Biodiversity Strategy and that , among other issues , analyses the pros and cons of the Action Plan , as well as the countryâ??s Forest Policy in ï?? ï?? ï?? ï?? . Andean Pact Decision ï?? ï?? ï?? and examines bioprospecting Her recent work has been on access to genetic resources , models implemented in the region . focusing on identifying strategies of value addition in the country of collection of the resources . Her latest publica - Francisco Chapela tion â?? Protección al Conocimiento Tradicional . Elementos Francisco Chapela is the head of the project â?? Indigenous Conceptuales para una Propuesta de Reglamentación . El and Community Biodiversity Conservation in Mexico â?쳌 . Mr . Caso de Colombia â?쳌 ( Co - author ) , relates to the protection Chapela holds a degree in Agricultural Engineering from of traditional knowledge in Colombia . the Universidad Autónoma Metropolitana â?? Xochimilco ( Mexico ) and an M.S . in Forest Management from the Luis Flores - Mimiça Colegio de Postgraduados and Instituto Tecnológico Luis Flores - Mimiça is a legal advisor for the London - based Agropecuario de Oaxaca . Mr . Chapela specializes in ï쳌® ï쳌§ ï쳌¯ Consumers International . Mr . Flores - Mimiça holds forest management , land use planning , and analysis of a law degree from the Universidad Católica de Chile and natural resource use policies . He presided over the Estudios received his M.S . in environmental law and sustainable Rurales yAsesoría Campesina from ï?? ï?? ï?? ï?? to ï?? ï?? ï?? ï?? and is an development from the same university . Mr . Flores - Mimiça independent consultant on environment , indigenous , and has been a consultant for the National Commission for rural communities . In ï?? ï?? ï?? ï?? , Mr . Chapela was the Mexican the Environment of Chile on access and benefit sharing contact for the Forest Stewardship Council , A.C . He has issues , including the implementation of the Convention coordinated and written various publications on commu - on Biological Diversity . nity - based management of biodiversity . José Carlos Fernández - Ugalde Dominique Hervé - Espejo José Carlos Fernández - Ugalde is the head of the Dominique Hervé - Espejo , a lawyer and researcher at the Environmental Economics area of the National Institute Environmental Law Center from the University of Chile , of Ecology . Mr . Fernández - Ugalde holds B.S . and M.S . received her Master of Laws ( LL.M ) in Environmental Law degrees in Economics from the Instituto Tecnológico from University College London in ï?? ï?? ï?? ï?? . Her research Autónomo de México and Cambridge University re - interests are the relationship between international and na - spectively . His research interests include trade , structural tional environmental law , mainly in the area of biodiversity adjustment and environment , economic valuation of urban and biotechnology . Regarding access to genetic resources reforestation , and economic analysis of environmental in Chile , she has worked for the National Commission of policies . Mr . Fernández - Ugalde worked at the World the Environment analyzing and providing legal assistance Conservation Monitoring Centre analyzing the impact of in the development of a national regulatory framework . commercial uses and regulatory measures on biodiversity Ms . Hervé - Espejo has published several articles in Chile conservation . He headed the Department of Ecological Land Planning and Natural Areas at El Colegio de la on the issue of biodiversity and biosafety . ï?? ï?? ï?? ï?? ï?? ï?? A ï쳌° ï쳌° ï쳌¥ ï쳌® ï쳌¤ ï쳌© ï쳌¸ ï?? proceedings , reports from task forces , and descriptions of Jorge Larson - Guerra major collections . A biologist from Universidad Nacional Autónoma de México , since ï?? ï?? ï?? ï?? Mr . Larson - Guerra has collaborated Mohamad Osman with the National Commission for the Knowledge and Use of Biodiversity ( ï쳌£ ï쳌¯ ï쳌® ï쳌¡ ï쳌¢ ï쳌© ï쳌¯ ) in activities related to Mohamad Osman is an associate professor with the School biodiversity policy . He was technical coordinator of the of Environmental and Natural Resources Sciences in the Mexican Delegation to the negotiations of the Cartagena Faculty of Science and Technology at the Universiti Protocol on the Transboundary Movement of Living Kebangsaan Malaysia ( UKM ) , and holds a B.S . in Modified Organisms , ï?? ï?? ï?? ï?? â?? ï?? ï?? ï?? ï?? . He was also fellow Agricultural Genetics and M.S . in Genetics from the of the Leadership Fund of the MacArthur Foundation University of California , Davis in ï?? ï?? ï?? ï?? , and Ph.D . in Plant with the project â?? Intellectual property and biological re - Breeding and Genetics from the University of Wisconsin , sources in rural Mexico â?쳌 , ï?? ï?? ï?? ï?? â?? ï?? ï?? ï?? ï?? . In ï?? ï?? ï?? ï?? and ï?? ï?? ï?? ï?? Madison in ï?? ï?? ï?? ï?? . He was involved in agricultural research Mr . Larson - Guerra was also a Member of the Mexican for ï?? ï?? years with the Malaysian Agricultural Research Delegations to the Intersessional Meeting of the Ad - Development Institute ( ï쳌­ ï쳌¡ ï쳌² ï쳌¤ ï쳌© ) , and had served for a long Hoc Working Group on Article ï?? j and related topics in time as a rice breeder and in various other positions at the Convention on Biological Diversity . Currently , he is ï쳌­ ï쳌¡ ï쳌² ï쳌¤ ï쳌© before joining ï쳌µ ï쳌« ï쳌­ in ï?? ï?? ï?? ï?? . Dr . Mohamadâ??s re - the coordinator of the Collective Biological Resources search interests are on the applications of ï쳌¤ ï쳌® ï쳌¡ molecular Program at ï쳌£ ï쳌¯ ï쳌® ï쳌¡ ï쳌¢ ï쳌© ï쳌¯ . markers and the use of induced mutations in crop im - provement and breeding research . Currently , his research Christian Lopéz - Silva focus is on rice and roselle improvement . Over the years , he has developed a strong interest on genetic resources , Christian Lopéz - Silva is a lawyer specialized in bio - biodiversity and their intellectual property , biosafety , technological law . He holds an M.S . in biotechnological legal and other related issues , and was actively involved law and he is currently pursuing doctoral research in the in many national committees including Task Force on Sheffield Institute of Biotechnological Law and Ethics , National Policy on Biological Diversity , Task Force on in the United Kingdom . Mr . Lopéz - Silva has worked in Access to Genetic Resources , Task Force on Biosafety and the environmental sector as legal adviser for the Mexican Drafting Committee on National Policy on Biotechnology . government in the regulation of biotechnology . He Dr . Mohamad has published several articles on access to worked for the Ministry of Environment and the National genetic resources and has represented Malaysia in inter - Commission for the Knowledge and Use of Biodiversity , national meetings and forums . which involved collaborating with the Interministerial Commission on Biosafety and Genetically Modified Organisms . Mr . Lopéz - Silva has advised in the negotia - Sally Petherbridge tion of scientific and bioprospecting agreements and has Sally Petherbridge received her LL.M . in environmental been involved in the analysis of regulation on access and law from the Australian National University , Canberra , benefit sharing , traditional knowledge , intellectual prop - in ï?? ï?? ï?? ï?? . From ï?? ï?? ï?? ï?? to ï?? ï?? ï?? ï?? she worked in the Access erty rights and biosafety . Taskforce and Biodiversity Policy Section in Australiaâ??s Department of the Environment and Heritage . She was Patrick McGuire closely involved in policy issues relating to access to genetic resources , traditional knowledge and intellectual A geneticist , with Ph.D . from the University of California , property , in particular , the Voumard Inquiry into Access Davis ( ï?? ï?? ï?? ï?? ) , he serves as director of the University of to Biological Resources in Commonwealth Areas and the Californiaâ??s Genetic Resources Conservation Program subsequent development of draft regulations on access ( ï쳌§ ï쳌² ï쳌£ ï쳌° ) , a statewide program in the Division of Agriculture and benefit sharing . She presented papers on develop - and Natural Resources . His research focus has been plant ments in Australia at the second meeting of the Panel of cytogenetics , crop improvement , and genetic resource Experts onAccess to Genetic Resources ( Montreal , March conservation . The mission of ï쳌§ ï쳌² ï쳌£ ï쳌° is with Californiaâ??s ï?? ï?? ï?? ï?? ) and at a ï쳌· ï쳌© ï쳌° ï쳌¯ regional workshop ( Brisbane , June biological diversity and its conservation in the broadest ï?? ï?? ï?? ï?? ) . She also attended the second meeting of the ï쳌· ï쳌© ï쳌° ï쳌¯ sense : onsite and offsite conservation of the native flora and Intergovernmental Committee on Intellectual Property and fauna , collections of germplasm amassed for agricultural , Genetic Resources , Traditional Knowledge and Folklore medicinal , and industrial uses , and collections of genetic ( Geneva , December ï?? ï?? ï?? ï?? ) and the sixth Conference of the stocks , tissues , cells , and ï쳌¤ ï쳌® ï쳌¡ developed for teaching and Parties ( ï쳌£ ï쳌¯ ï쳌° ï?? ) to the Convention on Biological Diversity research purposes . With ï쳌§ ï쳌² ï쳌£ ï쳌° , he has organized and sup - ( The Hague , April ï?? ï?? ï?? ï?? ) . Access and benefit sharing and ported training in genetic and genomic resources conserva - traditional knowledge were two of the major items on the tion , organized symposia and conferences , and coordinated and edited several publications : symposia and conference ï쳌£ ï쳌¯ ï쳌° ï?? agenda . ï?? ï?? ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ College , London University . Dr . Soberón - Mainero was a Manuel Ruiz member of the Subsidiary Technical Advisory Panel of Manuel Ruiz , is Director of the International Affairs the Global Environment Facility ( ï?? ï?? ï?? ï?? â?? ï?? ï?? ï?? ï?? ) and partici - and Biodiversity Program of the Peruvian Society for pated in the ScientificAdvisory Council of the ï쳌µ ï쳌® ï쳌¥ ï쳌° - World Environmental Law , based in Lima , Peru . Mr . Ruiz holds Conservation Monitoring Centre . Dr . Soberón - Mainero has an M.S . degree in Intellectual Property and Competition been a researcher at Universidad Nacional Autónoma de Law . He has been working on biodiversity - related issues México and his interests include population and conserva - since ï?? ï?? ï?? ï?? and has been actively involved in developing tion biology and mathematical modelling , topics in which national and regional policies and laws related to genetic he has published more than forty papers and chapters in resources , biosafety , and protection of traditional knowl - books . He has been member or president of the Mexican edge . He has been advisor to the Peruvian Government Delegation to most Conferences of the Parties of the and consultant on these issues to ï쳌¦ ï쳌¡ ï쳌¯ , ï쳌© ï쳌£ ï쳌´ ï쳌³ ï쳌¤ , ï쳌© ï쳌µ ï쳌£ ï쳌® , ï쳌· ï쳌² ï쳌© , Convention on Biological Diversity . ï쳌© ï쳌° ï쳌§ ï쳌² ï쳌© , Andean Community , and other international organi - zations . Mr . Ruiz has written multiple books and articles Tomme R . Young on the implementation of Decision ï?? ï?? ï?? , the protection of Tomme Young is a graduate of Hastings College of the traditional knowledge , and practical aspects related to the Law ( ï?? ï?? ï?? ï?? ) , and the University of Southern California implementation of the ï쳌¦ ï쳌¡ ï쳌¯ International Treaty on Plant ( ï?? ï?? ï?? ï?? ) . Ms . Young is Senior Legal Officer at the ï쳌© ï쳌µ ï쳌£ ï쳌® Genetic Resources for Food and Agriculture . Environmental Law Center in Bonn , Germany . Throughout her ï?? ï?? years as a lawyer , she has developed a specialized Preston T . Scott expertise in many areas of environmental law and policy . Preston T . Scott is a founder and currently serves Internationally , Ms.Young has served as a special advisor as Executive Director of the World Foundation for on environmental and sustainable development issues to Environment and Development ( ï쳌· ï쳌¦ ï쳌¥ ï쳌¤ ) , which is an in - foreign governments , under the auspices of several ï쳌µ ï쳌® dependent nonprofit organization based in Washington , agencies . She has advised the governments of ï?? ï?? coun - ï쳌¤ ï쳌£ . ï쳌· ï쳌¦ ï쳌¥ ï쳌¤ was established in ï?? ï?? ï?? ï?? to promote international tries in Europe , Africa , Asia , Oceania , and the Americas , cooperation and conflict resolution initiatives in the field on legislative drafting and negotiations and regulatory of environment and development . Mr . Scott is a graduate development . In the field of international agreements of the college and law school of the University of Virginia and ï쳌¡ ï쳌¢ ï쳌³ , Ms . Young has focused particularly on the ( having received degrees in law , and with honors in history , legal and legislative issues of practical implementation , government , and political theory ) and is a member of the most recently through designing and managing The ABS bars of the District of Columbia and Virginia . While at the Project , a three - year project aiming at providing tools University of Virginia School of Law , Mr . Scott served as and support to direct implementation of the ï쳌¡ ï쳌¢ ï쳌³ objec - Executive Editor of the Virginia Journal of International tives at international , regional , and local levels . Prior to Law . After entering law practice in ï?? ï?? ï?? ï?? , he developed this project , she has written extensively on a number of environmental audit and compliance programs under key legal and institutional issues relating to the creation , various air , water , hazardous waste , and toxic substances operations , and activities under the ï쳌£ ï쳌¢ ï쳌¤ , ï쳌µ ï쳌® ï쳌£ ï쳌¬ ï쳌¯ ï쳌³ , ï쳌£ ï쳌© ï쳌´ ï쳌¥ ï쳌³ , laws . His work subsequently focused on international Ramsar , the World Heritage Convention , and ï쳌µ ï쳌® ï쳌¦ ï쳌£ ï쳌£ , as technology transfers , embracing issues relating to envi - well as regional instruments and institutions . Her work ronmental law , intellectual property rights , finance , and focuses on increasing effectiveness , analyzing obstacles , trade as a partner with the Palo Alto , California law firm and implementing sustainable use through legal , legisla - of Fenwick & West , where he served as counsel to many tive , administrative and policy measures . Ms . Youngâ??s different national parties in various international disputes other international publications include legislative reports involving matters of substantive policy formulation as well and analyses addressing national and regional legislative as procedural issues relating to institutional arrangements status and particular environmental issues in the fields of and public participation . Mr . Scottâ??s recent work has fo - forest , conservation , environmental protection , pollution cused on specialized institutional arrangements relevant prevention , coastal and marine management , ï쳌© ï쳌° ï쳌² issues , to biodiversity conservation initiatives , with emphasis on liability , and compliance . access and benefit - sharing issues involving national parks and other protected areas . Jorge Soberón - Mainero Jorge Soberón - Mainero has served as Executive Secretary of the Mexican National Commission for the Knowledge and Use of Biodiversity since ï?? ï?? ï?? ï?? . He holds B.S . and M.S . degrees in biology from the Universidad Nacional Autónoma de México and a Ph.D . in Biology from Imperial ï?? ï?? ï?? A3 Appendix 3 . Contact Information of Primary Contributors Part 1 . Persons consulted for specific country information ( case study authors and survey respondents ) grouped first by status of country with respect to ABS policies and then by country 4 . Mexico A . Countries with ABS policies Francisco Chapela 1 . Colombia Estudios Rurales y Asesoría Campesina Paola Ferreira Priv . Elvira 120 , Fracc . Villa San Luis 68020 Consultant Oaxaca , México 85 G Prospect St . era @ mesoamerica.org.mx Ridgefield , CT 06877 USA http : / / www.mesoamerica.org.mx / era / ferreirap @ aol.com José Carlos Fernández - Ugalde 2 . Costa Rica Dirección de Economía Ambiental Instituto Nacional de Ecología Jorge Cabrera - Medaglia 5to nivel , Av . Revolución 1425 , Tlacopac San Angel 01040 Consultant México , D.F . México Apdo . 1487 - 1002 cfernan @ ine.gob.mx , jc_fernan @ hotmail.com San José , Costa Rica http : / / www.ine . . gob.mx / jorgecmedaglia @ hotmail.com Jorge Larson - Guerra 3 . Ecuador Cordinador del Proyecto Recursos Biologicos Colectivos Luis Suarez Comisión nacional para el conocimiento y uso de la Director Ecociencia biodiversidad ( CONABIO ) Fundación Ecuatoriana de Estudios Ecológicos Avenida Liga Periférico - Insurgentes Sur No . 4903 , San Cristóbal N44 - 495 y Seymour Col . Parques del Pedregal , Delegación Tlalpan Quito , Ecuador 14010 México , D.F . México Biodiversidad @ ecociencia.org jlarson @ xolo.conabio.gob.mx http : / / www.conabio.gob.mx / Joseph Henry Vogel Associate Profesor Christian López - Silva ( formerly Professor of Economics at FLACSO , Ecuador ) Consultant Department of Economics , University of Puerto Rico Avenida Liga Periférico - Insurgentes Sur No . 4903 , Rios Piedras Col . Parques del Pedregal , Delegación Tlalpan PR 00931 , San Juan , Puerto Rico 14010 México , D.F . México josephvogel @ usa.net , josephvogel @ hotmail.com christian_adicional @ yahoo.com ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ 4 . Mexico continued 9 . United States of America ( USA ) Jorge Soberón Preston Scott Secretario Ejecutivo Executive Director Comisión nacional para el conocimiento y uso de la World Foundation for Environment and Development ( WFED ) biodiversidad ( CONABIO ) 1816 Jefferson Place , NW Avenida Liga Periférico - Insurgentes Sur No . 4903 , Washington , DC 20036 - 2505 USA Col . Parques del Pedregal , Delegación Tlalpan PTScott @ aol.com 14010 México , D.F . México http : / / wfed.org / jsoberon @ xolo.conabio.gob.mx http : / / www.conabio.gob.mx / B . Countries working towards the development of ABS policies 5 . Philippines Paz J . Benavides II 1 . Australia Consultant Sally Petherbridge 408 Sterten Place Condominium , 116 Maginhawa Street , Environment Australia Teachers â?? Village 3 Myall St Quezon City 1100 Philippines Oâ??Connor ACT 2602 Australia pjbcaps @ broline.com Sally.Petherbridge @ ea.gov.au http : / / environment.gov.au / 6 . Peru Manuel Ruiz 2 . Cambodia Sociedad Peruana de Derecho Ambiental Men Sarom Prolongación Arenales 437 Director Plant Breeding Lima 27 , Peru Cambodian Agricultural Research and Development Institute mruiz @ spda.org.pe ( CARDI ) http : / / www.spda.org.pe / P.O . Box 01 Phnom Penh , Cambodia 7 . Samoa msarom @ bigpond.com.kh Vainuupo Jungblut Principal Environment Officer 3 . Canada Department of Lands and Environment , Private Bag Kelly Banister Apia , Samoa Assistant Professor Vainuupo.Jungblut @ mnre.gov.ws School of Environmental Studies , University of Victoria Clark Peteru University House 4 , Box 3060 Environmental Legal Advisor Victoria , BC , V8W 3R4 Canada South Pacific Regional Environment Programme kel @ uvic.ca PO Box 240 http : / / web.uvic.ca / ~ scishops Apia , Samoa clarkp @ sprep.org.ws , peteru @ samoa.ws 4 . Chile Cedric Schuster Luis Florez - Mimiça Director Consultant Pacific Environment Consultants Ltd El Vergel 2647 , Departamento 302 , Providencia PO Box 3702 Santiago , Chile Apia , Samoa lucasarbol @ yahoo.com.ar cmlschuster @ yahoo.co.nz , cschuster @ conservation.ws Dominique Hervé - Espejo Professor 8 . Thailand Facultad de Derecho Jade Donavanik Universidad Diego Portales Consultant República 105 Thailand Biodiversity Center Santiago , Chile 15th Floor Gypsum Metropolitan Tower , Dominique.herve @ prof.udp.cl 539 / 2 Sri - Ayudhya Rd . Bangkok , 10400 Thailand 5 . China jade @ biotec.or.th Dayuan Xue Chaweewan Hutacharern Director of Nature Conservation and Biodiversity Division , Head of Entomology and Microbiology Group Nanjing Institute of Environmental Science , State Dept . of National Parks , Wildlife , and Plant Conservation Environmental Protection Administration ( SEPA ) 61 Paholyothin Road , Chatuchak 8 jiang - wang - miao St . , P.O.Box 4202 Bangkok 10900 Thailand Nanjing 210042 P.R . China chahut @ forest.go.th duedayuan @ hotmail.com http : / / www.nies.org ï?? ï?? ï?? ï?? ï?? ï?? A ï쳌° ï쳌° ï쳌¥ ï쳌® ï쳌¤ ï쳌© ï쳌¸ ï?? 6 . Cook Islands 11 . Indonesia Ben Ponia B . Satyawan Wardhana Aquaculture adviser Head of Division for Biodiversity Conservation SPC - Secretariat of the Pacific Community Ministry of Environment B.P . D5 - 98848 Noumea Cedex 4th Floor , Building B , Ministry of Environment ; D.I . Panjaitan New Caledonia , Cook Islands Kav 24 Benp @ spc.int Jakarta 13410 Indonesia http : / / www.spc.int / iwan_wardhana @ hotmail.com ; chmcbdri @ rad.net.id http : / / www.menlh.go.id / 7 . El Salvador 12 . Japan Jorge Ernesto Quezada Díaz Gerente de Recursos Biológicos Junko Shimura Ministerio de Medio Ambiente y Recursos Naturales Principal Research Scientist Alameda Roosevelt y 55 avenida norte Torre El Salvador National Institute for Environmental Studies ( IPSFA ) , 4 nivel 16 - 2 Onogawa Tsukuba San Salvador , El Salvador Ibaraki 305 - 8506 Japan quezada @ marn.gob.sv junko @ nies.go.jp http : / / www.marn.gob.sv http : / / www.sp2000ao.nies.go.jp / Seizo Sumida 8 . Fiji Managing Director Luke V . Qiritabu Japan Bioindustry Association Department of Environment Grande Bldg 8F , 26 - 9 Hatchobori 2 - Chome , Chuo - ku P . O . Box 2131 , Government Buildings Tokyo 104 - 0032 Japan Suva , Fiji sumida @ jba.or.jp lqiritabu @ govnet.gov.fj http : / / www.jba.or.jp / Manasa Sovaki 13 . Malaysia Principal Environment Officer Mohamad bin Osman Department of Environment School of Environmental and Natural Resource Sciences PO Box 2131 , Government Buildings Universiti Kebangsaan Malaysia Suva , Fiji 43600 UKM Bangi biodiversity @ suva.is.com.fj , msovaki @ yahoo.com Selangor , Malaysia 9 . Guatemala mbopar @ pkrisc.cc.ukm.my Yuri Giovanni Melini 14 . Marshall Islands Centro de Acción Legal - Ambiental and Social de Guatemala Raynard Gideon ( CALAS ) Ministry of Foreign Affairs 13 calle 8 - 61 . zona 11 , P.O . Box 1349 Nivel 2 Apartamento « D » Colonia Mariscal Majuro , Marshall Islands 96960 C.P . 01011 Ciudad de Guatemala , Guatemala mofaadm @ ntamar.net direccion @ calasgt.org and yuri @ melini.com http : / / www.calas.org.gt / 15 . Micronesia M . J . Mace 10 . Honduras Former Assistant Attorney General José Antonio Fuentes FSM Department of Justice Director General de Biodiversidad 400 Magazine Street , Suite 401 Secretaría de Recursos Naturales y Ambiente ( SERNA ) New Orleans , LA 70130 100 Mts . al Sur del Estadio Nacional mjmace02 @ yahoo.com Tegucigalpa , M.D.C . Honduras dibio @ sdnhon.org.hn , ddibio @ sdnhon.org.hn 16 . New Zealand http : / / www.serna.gob.hn / Doug Calhoun Carlos Roberto Midence Partner Law at A J Park Analista Ambiental Huddart Parker Building , 1 Post Office Square , Secretaria de Recursos Naturales y Ambiente ( SERNA ) PO Box 949 100 Mts . al Sur del Estadio Nacional Wellington , New Zealand Tegucigalpa , M.D.C . Honduras doug.calhoun @ ajpark.com , becky.white @ ajpark.com carlosmidence @ hotmail.com http : / / www.ajpark.com http : / / www.serna.gob.hn / ï?? ï?? ï?? ï?? ï?? ï?? A ï쳌£ ï쳌£ ï쳌¥ ï쳌³ ï쳌³ ï쳌© ï쳌® ï쳌§ B ï쳌© ï쳌¯ ï쳌¤ ï쳌© ï쳌¶ ï쳌¥ ï쳌² ï쳌³ ï쳌© ï쳌´ ï쳌¹ ï쳌¡ ï쳌® ï쳌¤ S ï쳌¨ ï쳌¡ ï쳌² ï쳌© ï쳌® ï쳌§ ï쳌´ ï쳌¨ ï쳌¥ B ï쳌¥ ï쳌® ï쳌¥ ï쳌¦ ï쳌© ï쳌´ ï쳌³ 17 . Nicaragua Javier Guillermo Hernández Munguía 23 . Singapore Asesor legal Lena Chan Ministerio del Ambiente y los Recursos Naturales Assistant Director ( Nature Conservation ) Km . 12 1â쳌?2 Carretera Norte National Parks Board , Singapore Botanic Gardens Managua , Nicaragua 1 Cluny Road , Singapore 259569 javihermun @ hotmail.com Lena_CHAN @ nparks.gov.sg http : / / www.marena.gob.ni / http : / / www.nparks.gov.sg / parks / sbg / par - sbg.shtml 18 . Niue 24 . Solomon Islands Tagaloa Cooper Moses Biliki Head Environment Officer Director Environment Unit , Department of Community Affairs Environment and Nature Conservation Division , PO Box 77 Ministry of Forests , Environment and Nature Conservation Niue P.O Box G24 environment.ca @ mail.gov.nu Honiara , Solomon Islands http : / / www.gov.nu / appeal.htm mbiliki @ hotmail.com , komaridi @ welkam.solomon.com.sb , mosesb @ solomon.com.sb 19 . Panama Carolina Lasen Diaz Marisol Dimas and Adela Olivardia Staff Lawyer Departamento de Conservación de la Biodiversidad , Foundation for International Environmental Law and Autoridad Nacional Ambiental Development ( FIELD ) Albrook , edificio 804 52 - 53 Russell Square , Panama City , Panama London WC1B 4HP UK biodiversidad @ anam.gob.pa carolina.lasen @ field.org.uk http : / / www.anam.gob.pa / http : / / www.field.org.uk Cedric Schuster 20 . Papua New Guinea Director Rosa N . Kambuou Pacific Environment Consultants Ltd Principal Scientist PO Box 3702 National Agricultural Research Institute Apia , Samoa PO Box 1828 cmlschuster @ yahoo.co.nz , cschuster @ conservation.ws Port Moresby , National Capitol District , Papua New Guinea dlplaloki @ datec.com.pg 25 . Vanuatu http : / / www.nari.org.pg / Donna Kalfatak NBSAP Project Coordinator 21 . Republic of Korea Environment Unit Sang - Weon Bang Ministry of Agriculture , Livestock , Forestry , Fisheries and Research Fellow Environment Korea Environment Institute ( KEI ) Private Mail Bag 063 Bulkwang - Dong 613 - 2 , Eunpyong - Gu ( Zip : 122 - 706 ) Port Vila , Vanuatu Seoul , Republic of Korea environ @ vanuatu.com.vu swbang @ kei.re.kr http : / / www.kei.re.kr 26 . Vietnam Hoang Duong Tung 22 . Russian Federation Deputy Chief , Networking and Database Management Sergey M . Alexanian Division , National Environment Agency ( NEA ) of Vietnam N.I . Vavilov All - Russian Research Institute of Plant Industry 67 Nguyen Du 42 - 44 Bolshaya Morskaya St . Hanoi , Vietnam 190000 St . Petersburg , Russian Federation htung @ nea.gov.vn s.alexanian @ vir.nw.ru http : / / www.nea.gov.vn / http : / / www.vir.nw.ru / Vera Moshentseva Senior Analyst Department of Life and Earth Sciences Ministry of Industry , Science and Technologies of the Russian Federation 125009 Moscow , Tverskaya 11 Russian Federation moshentseva @ minstp.ru ï?? ï?? ï?? ï?? ï?? ï?? A ï쳌° ï쳌° ï쳌¥ ï쳌® ï쳌¤ ï쳌© ï쳌¸ ï?? C . Countries not involved in any process leading to the 4 . Palau development of ABS policies Steven A . Daugherty Assistant Attorney General 1 . Kiribati PO . Box 1365 Palau Tererei Abete - Reema StevenAD @ palaunet.com Environment and Conservation Division - ECD , MESD , Ministry of Environment 5 . Tonga P.O . Box 234 , Bikenibeu Tarawa , Kiribati Aminiasi Kefu tererei.mesd2 @ tskl.net.ki Senior Crown Counsel The Solicitor General , Crown Law Department , 2 . Laos P.O . Box 85 Nukuâ??alofa , Tonga Sourioudong Sundara aminiasi.kefu @ tcc.to Director General , Research Institute of Science , Science Technology and Environment Agency , Prime Ministerâ??s Office 6 . Tuvalu P.O . Box 2279 Vientiane , Laos Cedric Schuster sourioudong @ yahoo.uk , science @ laotel.com Director Pacific Environment Consultants Ltd 3 . Nauru PO Box 3702 Apia , Samoa Cedric Schuster cmlschuster @ yahoo.co.nz , cschuster @ conservation.ws Director Pacific Environment Consultants Ltd PO Box 3702 Apia , Samoa cmlschuster @ yahoo.co.nz , cschuster @ conservation.ws Part 2 . Editors and authors of analysis chapters , alphabetically by surname . Stephen B . Brush Brian D . Wright Professor Professor Department of Human and Community Development Department of Agricultural and Resource Economics , University of California University of California One Shields Avenue 207 Giannini Hall # 3310 Davis CA 95616 - 8602 USA Berkeley , CA 94720 - 3310 USA sbbrush @ ucdavis.edu wright @ are.berkeley.edu Santiago Carrizosa Tomme Rosanne Young Research Ecologist Senior Legal Officer Genetic Resources Conservation Program IUCN Environmental Law Center University of California Godesberger Allee 108 - 112 One Shields Avenue 53175 Bonn , Germany Davis CA 95616 - 8602 USA tyoung @ elc.iucn.org scarrizosa @ ucdavis.edu.edu , scarrizosa @ yahoo.com http : / / www.iucn.org / themes / law / http : / / www.grcp.ucdavis.edu / index.htm Patrick E . McGuire Director Genetic Resources Conservation Program , University of California One Shields Avenue Davis CA 95616 - 8602 USA pemcguire @ ucdavis.edu ï?? ï?? ï?? ï?? ï?? ï?? IUCN Environmental Law Programme Accessing Accessing Biodiversity and Sharing the Beneï¬쳌ts:Biodiversity IUCN â?? The World Conservation Union Lessons from Implementing the Founded in 1948 , The World Conservation Union brings together States , government agencies and a diverse range of non - governmental organizations in a unique world Convention on Biological Diversity and partnership : over 1000 members in all , spread across some 140 countries . As a Union , IUCN seeks to inï¬?uence , encourage and assist societies throughout the Sharing world to conserve the integrity and diversity of nature and to ensure that any use of natural Edited by Santiago Carrizosa , Stephen B . Brush , resources is equitable and ecologically sustainable . A central Secretariat coordinates the Brian D . Wright , and Patrick E . McGuire IUCN Programme and serves the Union membership , representing their views on the the world stage and providing them with the strategies , services , scientiï¬쳌c knowledge and technical support they need to achieve their goals . Through its six Commissions , IUCN Beneï¬쳌ts : draws together over 10,000 expert volunteers in project teams and action groups , focusing in particular on species and biodiversity conservation and the management of habitats and natural resources . The Union has helped many countries to prepare National Conservation Strategies , and demonstrates the application of its knowledge through the ï¬쳌eld projects Lessons it supervises . Operations are increasingly decentralized and are carried forward by an expanding network of regional and country ofï¬쳌ces , located principally in developing countries . The World Conservation Union builds on the strengths of its members , networks and from partners to enhance their capacity and to support global alliances to safeguard natural resources at local , regional and global levels . Implementing IUCN Environmental Law Programme the Environmental Law Centre Convention Godesberger Allee 108 - 112 53175 Bonn , Germany Tel : + 49 228 2692231 Fax : + 49 228 2692250 E - mail : elcsecretariat @ iucn.org www.iucn.org / themes / law on Biological IUCN Publications Services Unit 219c Huntingdon Road Cambridge CB3 0DL United Kingdom Tel : + 44 1223 277894 Diversity Fax : + 44 1223 277175 E - mail : info @ books.iucn.org www.iucn.org / bookstore IUCN Environmental Policy and Law Paper No . 54