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File Information 2004. Santiago Carrizosa, Stephen B. Brush, Brian D. Wright, and Patrick E. McGuire. IUCN Environmental Policy and Law Paper No. 54, World Conservation Union (IUCN), Gland, Switzerland and Cambridge, UK. xiv+316 p. ISBN: 2-8317-0816-8
Authors
Brush, Stephen
Professor   Anthropologist-AES
Cultural change and development, social anthropology; cultural ecology, environmental issues in agricultural development, Latin American studies, peasant society
Carrizosa, Santiago :
McGuire Dr, Patrick E

Genetics, genetic resources conservation, conservation biology, conservation genetics
Wright, Brian
AES Agricultural Economist Professor GFAE
Commodity market stabilization, agricultural price policy, economic development, public finance, research and development, natural resource economics and industrial organization
Date Added Sep 23, 2008
OCR Text
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 . 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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 . 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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 . 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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?? . 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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?? . 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Bioprospecting : Myths , realities and poten - October ï?? ï?? ï?? ï?? . tial impacts on sustainable