Common Pools of Genetic Resources: Equity and Innovation in International Biodiversity Law [1 ed.] 9781135069704, 9780415537674

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Common Pools of Genetic Resources

The Convention on Biological Diversity (CBD) strives for the sustainable and equitable utilization of genetic resources, with the ultimate goal of conserving biodiversity. The CBD and the Nagoya Protocol, which has since been elaborated, suggest a bilateral model for access to genetic resources and the sharing of benefits from their utilization. There is concern that the bilateral exchange, ‘genetic resource for benefit sharing’, could have disappointing results because providers are left out of the process of research and development, it is difficult to trace benefits to sources, and providers owning the same resource may complain of being excluded from benefit sharing. Thus, the CBD objective of full utilization and equitability may become flawed. Common Pools of Genetic Resources: Equity and Innovation in International Biodiversity Law suggests common pools as a complementary approach to bilateralism. This is one of the first books to reply to a number of complex legal questions related to the interpretation and implementation of the Nagoya Protocol. Taking an inductive approach, it describes existing pools and analyses how they are organized and how they perform in terms of joint R&D and benefit sharing. It presents case studies of the most characteristic types of common pools, provides suggestions for further developing existing pools to cope with the requirements of the CBD and NP and, at the same time, uses the clauses these conventions contain to open up for common approaches. Written by a team of expert academics and practitioners in the field, this innovative book makes a timely and valuable contribution to academic and policy debates in international environmental law, international biodiversity law, intellectual property law, climate law and the law of indigenous populations. Dr Evanson Chege Kamau is senior research fellow in law at the Research Centre for European Environmental Law (FEU) at the University of Bremen. Professor Gerd Winter is Co-Director of the Research Centre for European Environmental Law (FEU) at the University of Bremen.

Routledge Research in International Environmental Law

Available titles in this series: International Environmental Law and the Conservation of Coral Reefs Edward J. Goodwin Environmental Governance in Europe and Asia A Comparative Study of Institutional and Legislative Frameworks Jona Razzaque Climate Change, Forests and REDD Lessons for Institutional Design Joyeeta Gupta, Nicolien van der Grijp, Onno Kuik Common Pools of Genetic Resources Equity and Innovation in International Biodiversity Law Evanson Chege Kamau & Gerd Winter

Ironically, the Nagoya Protocol seems to have reignited the discussion on options to provide access to genetic resources and to share the resulting benefits without, however, following the bilateral provider/ user approach envisaged by the Protocol. ‘Common Pools of Genetic Resources’ provides a plethora of local, national, transnational and international alternatives to the Protocol’s bilateral approach and ought to become compulsory reading for stakeholders and policymakers tasked with devising ABS policies. Common pools, if well designed, may strike a balance between the interests of users and providers of genetic resources, between access and benefit-sharing and between equity and innovation. Dan Leskien Secretariat of the Commission on Genetic Resources for Food and Agriculture, Food and Agriculture Organization of the United Nations

This publication brings together a remarkable array of expertise and knowledge as well as a useful range of cases and approaches, which highlight the fundamental issues regarding common pools of genetic resources. These efforts have certainly opened up fruitful lines of inquiry on the issue and insights that policy makers, scholars and other practitioners alike will find very helpful, especially as the relevant intergovernmental processes tackle both the immanent and emerging legal, policy and political challenges. Kent Nnadozie Secretariat of the International Treaty on Plant Genetic Resources for Food and Agriculture, Food and Agriculture Organization of the United Nations

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Common Pools of Genetic Resources Equity and Innovation in International Biodiversity Law Evanson Chege Kamau and Gerd Winter

First edition published 2013 by Taylor & Francis Ltd First published 2013 by Routledge 2 Park Square, Milton Park, Abingdon, Oxon OX14 4RN Simultaneously published in the USA and Canada by Routledge 711 Third Avenue, New York, NY 10017 Routledge is an imprint of the Taylor & Francis Group, an informa business © 2013 Evanson Chege Kamau and Gerd Winter selection and editorial material, Evanson Chege Kamau and Gerd Winter; individual chapters, the contributors. The right of Evanson Chege Kamau and Gerd Winter to be identified as author of the editorial material, and of the individual authors as authors of their contributions, has been asserted in accordance with sections 77 and 78 of the Copyright, Designs and Patents Act 1988. All rights reserved. The purchase of this copyright material confers the right on the purchasing institution to photocopy pages which bear the photocopy icon and copyright line at the bottom of the page. No part of this book may be reprinted or reproduced or utilised in any form or by any electronic, mechanical, or other means, now known or hereafter invented, including photocopying and recording, or in any information storage or retrieval system, without permission in writing from the publishers. Trademark notice: Product or corporate names may be trademarks or registered trademarks, and are used only for identification and explanation without intent to infringe. British Library Cataloguing in Publication Data A catalogue record for this book is available from the British Library Library of Congress Cataloging-in-Publication Data Common pools of genetic resources : equity and innovation in international biodiversity law / Evanson Chege Kamau and Gerd Winter. -- First edition. pages cm ISBN 978-0-415-53767-4 -- ISBN 978-0-203-59088-1 1. Germplasm resources conservation--Law and legislation. 2. Biodiversity conservation--Law and legislation. 3. Traditional ecological knowledge--Law and legislation. I. Kamau, Evanson C., editor of compilation. II. Winter, Gerd., editor of compilation. K3488.5.C66 2013 346.04'69534--dc23 2012047434 ISBN13: 978-0-415- 53767-4 (hbk) ISBN13: 978-0-203- 59088-1 (ebk) Typeset in ITC New Baskerville Std by Saxon Graphics Ltd, Derby

Contents

List of figures List of tables Notes on contributors Foreword Preface Abbreviations Introduction 1

Common pools of genetic resources and related traditional and modern knowledge: an overview

xi xiii xv xxi xxiii xxv 1 3

GER D W INTER

PART I

Local approaches 2

Common pools of traditional knowledge: the story of the Kukula traditional health practitioners of Bushbuckridge, Kruger to Canyons (K2C) Biosphere Reserve, South Africa

27

29

G I N O C O C C H I A RO A N D B R I T TA RU T E R T

3

Common pools of traditional knowledge and related genetic resources: a case study of San-Hoodia

40

E VA N S O N C H E G E K A M AU

4

Reinventing traditional medicine: Pacari and its struggle towards health, environmental protection and benefit sharing JOH N BER N H A R D K L EBA

55

viii

5

Contents

Guardians of the seed: the role of Andean farmers in the caring and sharing of agrobiodiveristy

79

M A R I O T A P I A A N D B R E N DA N T O B I N

PART II

National approaches

101

6

103

Genetic resources common pools in Brazil JULIANA SANTILLI

7

Developing a common pools strategy for genetic resources for food and agriculture: a case study of Malaysia

127

GU R DI A L SI NGH N I JA R

8

Common pools of traditional Chinese medical knowledge in China

150

T I A N B AO Q I N

9

Common pools in aquaculture: exploring patent law, ABS and sui generis options

168

M O R T E N WA L L Ø E T V E D T

PART III

Transnational approaches

191

10 Practices of exchanging and utilizing genetic resources for food and agriculture and the access and benefit-sharing regime 193 S É L I M L OUA F I A N D M A R I E S C H L O E N

11 Global scientific research commons under the Nagoya Protocol: governing pools of microbial genetic resources

224

T O M D E D E U RWA E R D E R E , A R I A N N A B RO G G I AT O A N D DI M I T R A M A NOU

12 Networks of ex situ collections of genetic resources

246

CHR IST I N E G ODT

13 Biological databases for marine organisms: what they contain and how they can be used in ABS contexts

268

G O RC H D E T L E F B E V I S F E D D E R

14 Knowledge commons, intellectual property and the ABS regime GER D W INTER

285

Contents ix PART IV

International approaches

303

15 ABS, justice, pools and the Nagoya Protocol

305

P E T E R -T O B I A S S T O L L

16 The World Health Organization’s Pandemic Influenza Preparedness Framework as a public health resources pool

315

MARIE WILKE

17 The multilateral system of the International Treaty on Plant Genetic Resources for Food and Agriculture: lessons and room for further development

343

E VA N S O N C H E G E K A M AU

18 Exploring bases for building common pools in Eastern Africa

373

E VA N S O N C H E G E K A M AU

19 Common pools for marine genetic resources: a possible instrument for a future multilateral agreement addressing marine biodiversity in areas beyond national jurisdiction

399

T HOM A S GR EIBER

Index

415

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Figures

3.1 The distribution of Hoodia and occurrence of the San in southern Africa 4.1 Map of the remaining vegetation in the Cerrado 4.2 Dona Eterna explains techniques of sustainable extractivism 4.3 Collective production of traditional medicines in the Farmacinha do Cerrado 4.4 Cedro’s community leaders and labelled sugar cane juice candy 4.5 Cedro’s community pharmacy 5.1 Arariwa ‘community conservationists’ maintain the Potato Park gene bank in the community of Paru Paru 5.2 Arariwa ‘community conservationists’ of the Potato Park prepare samples of local potato varieties 11.1 Theoretical models of global scientific research collaboration with basic research assets 13.1 Partial screenshot of the GenBank entry on the genetic construct ‘opAFP-GHc2’ 13.2 Distribution maps of species from which the genetic sequences for ‘opAFP-GHc2’ were obtained 16.1 The functioning of the GISRS and the two SMTAs 17.1 Flow of material and benefits within the multilateral system 18.1 Distribution of Vernonia galamensis 18.2 Regions of Africa

41 57 63 64 67 68 88 89 230 273 274 322 350 377 377

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Tables

3.1 Some applications filed in the USA after the isolation of P57 by CSIR 3.2 Chronology of events shaping the San-Hoodia pool 7.1 Annex crops held by public universities 11.1 Analysis of MTA conditions in 48 collections in March 2012 13.1 List of source states for AquAdvantage® salmon 13.2 Non-exhaustive list of research papers, patents and firms relevant to the research and development of the genetic construct ‘opAFP-GHc2’ 17.1 Sample of a single search result 18.1 Some Annex I crops of great importance to the region 18.2 Status of signature/ratification/accession of the ITPGRFA in the eastern Africa region 18.3 Provisions providing a basis for construction of an EA common pool

44 46 135 234 275

276 348 380 382 393

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Notes on contributors

Arianna Broggiato is a post-doctoral researcher in law at the Biodiversity Governance Unit of the Centre for the Philosophy of Law at the Université Catholique de Louvain (http://biogov.cpdr.ucl.ac.be). She holds an LLM in Environmental Law (UK – Nottingham University) and PhD in International Law (Milano – Universita’ degli Studi di Milano). Her research focuses on environmental law and the law of the sea, with a special focus on the legal regimes of genetic resources. [email protected] Brendan Tobin (PhD, barrister, Ashoka fellow) has worked for over 20 years as an activist, researcher and consultant on issues of environmental justice and minority rights. An active participant in international ABS and TK debates, he co-chaired negotiations leading to adoption of the Bonn ABS Guidelines. A research fellow at Griffith University Law School, his work focuses on customary law, intellectual property and protection of the human rights of indigenous peoples, farmers and livestock keepers. [email protected] Britta Rutert is currently writing her PhD thesis on ‘Traditional Knowledge and Intellectual Property Rights’ at the Free University of Berlin, Institute of Social and Cultural Anthropology. She conducted her PhD fieldwork on the traditional knowledge commons of the Bushbuckridge Traditional Healers Association in South Africa. Rutert is collaborating with Natural Justice, an NGO working on the sustainable use of biodiversity through the governance of indigenous peoples. She has also worked for various development organizations in Africa and Germany. [email protected] Christine Godt has been a professor at the University of Oldenburg since 2010, Director of the Hanse Law School, Jean Monnet Chair of European and International Economic Law, including Intellectual Property, Comparative Property Law and Private Environmental Law. Her research focuses on genetic resources, technology transfer and property regimes. She completed her habilitation in 2005 (‘Eigentum an

xvi

Notes on contributors

Information’, Mohr Siebeck 2007) after having been awarded a doctorate in law in 1995 (‘Haftung für ökologische Schäden’ (Duncker & Humblot 1997), both from the University of Bremen. She did her Bar exams in 1997 and 1991 in Berlin. [email protected]. Dimitra Manou is a post-doctoral researcher at the Biodiversity Governance Unit of the Centre for the Philosophy of Law at the Université Catholique de Louvain (http://biogov.cpdr.ucl.ac.be). She is a graduate in law with an MSc in International Studies and a PhD in Legal Studies. [email protected] Evanson Chege Kamau is senior research fellow in law at the Research Centre for European Environmental Law (FEU), University of Bremen, Germany. He holds a doctorate in law and a Master’s degree in European and international law. His research focuses on genetic resources, environment, development and intellectual property issues. He has done several legal consultancies in ABS. Kamau is a co-editor of the book Genetic Resources, Traditional Knowledge and the Law. Solutions for Access and Benefit Sharing (Earthscan 2009) and a co-author of the IUCN Explanatory Guide to the Nagoya Protocol on Access and Benefit Sharing (Gland, Switzerland 2012). [email protected] Gerd Winter is a professor of public law and sociology of law at the University of Bremen. He is Co-director of the Research Centre for European Environmental Law (FEU) (www.feu.uni-bremen.de). His focus of teaching, research and publications is on administrative and environmental law in comparative and international perspectives. He has also worked as a legal consultant in various countries. Winter is a co-editor of the book Genetic Resources, Traditional Knowledge and the Law. Solutions for Access and Benefit Sharing (Earthscan 2009). For further information see his personal website www-user.uni-bremen. de/~gwinter. [email protected] Gino Cocchiaro is a lawyer working for Natural Justice: Lawyers for Communities and the Environment, an NGO that strives for the conservation and sustainable use of biodiversity through the selfdetermination of indigenous peoples and local communities. Cocchiaro is based in Cape Town, South Africa, where his work focuses on the African Biocultural Community Protocols (BCP) and Biocultural Rights Initiatives. [email protected] Gorch Detlef Bevis Fedder is a marine tropical ecologist by training. His MSc thesis focused on options for a more equitable allocation of funds under the Global Environment Facility. His PhD thesis in law dealt with marine access and benefit sharing and how biological databases may contribute to the global multilateral benefit sharing mechanism. He now works as a post-doctoral associate at the international graduate

Notes on contributors

xvii

school INTERCOAST in Bremen and continues researching on legal issues in the marine realm. [email protected] Gurdial Singh Nijar has an LLB. (Hons) from King’s College London, an LLM from the Universiti Malaya, and is a barrister of law in Middle Temple, London, an advocate and solicitor at the High Court of Malaya, and a barrister at the Supreme Court of New South Wales and Victoria (Australia). Presently, he is a Professor of Law at the Universiti Malaya in Kuala Lumpur, Malaysia. He is Director of the Centre of Excellence for Biodiversity Law (CEBLAW), Malaysia. His areas of research are biodiversity law, biosafety law, traditional knowledge and IPRs and food security related issues, ABS and the multilateral system of the ITPGRFA. [email protected]; [email protected] John Bernhard Kleba has a doctoral degree in Social Sciences from the University of Bielefeld, Germany (2000). Since 2005, he has been Senior University Lecturer of Political Science and Sociology at the Aeronautics Technological Institute (ITA), Brazil. In 2010–2011 he did post-doctoral research at the University of Warwick in the United Kingdom. His research focuses on socio-legal studies, science and technology studies, political justice and environmental sociology. [email protected] Juliana Santilli is a lawyer and a public prosecutor for the Federal District of Brazil, specializing in environmental and cultural heritage law and public policies. She has a PhD in Environmental Law and is an associate researcher in environmental law at the University of Brasília, Center for Sustainable Development. [email protected] Marie Schloen is a research fellow on global governance of genetic resources for food and agriculture at CIRAD in Montpellier, France, and at the Research Centre for European Environmental Law of the University of Bremen, Germany. She is an agronomist and plant breeder by profession. She has previously served as a professional officer at the secretariat of the ITPGRFA and at the Seed and Plant Genetic Resources Service of the FAO in Rome, Italy. [email protected] Marie Wilke heads the international trade law programme at the International Centre for Trade and Sustainable Development (ICTSD). In that capacity, she also participated in the PIP Framework and the Nagoya Protocol negotiation processes. Furthermore, she is a legal research fellow at the Centre for International Sustainable Development Law (CISDL) where her research focuses mainly on natural resource management and international economic law. She holds an LLM in public international law (summa cum laude) from Helsinki University. [email protected] Mario Tapia (PhD, Ashoka fellow, Adviser to ANPE), an agronomist, is a renowned expert on Andean agriculture with more than 40 years’ experience in rural development and genetic resource conservation. Professor at the Universidad Agraria La Molina in Lima, he has worked

xviii

Notes on contributors

as a consultant for many national and international agencies including FAO, IICA, COSUDE, IDRC, GTZ and GEF. His many publications include books on the management of mountainous ecosystems, Andean agrobioversity, and eco-development in the Andes. mariotapia@amauta. rcp.net.pe Morten Walløe Tvedt is a senior research fellow in law at the Fridtjof Nansen Institute (FNI) in Norway. His research covers intellectual property rights and their relation to the conservation of nature, poverty alleviation and sustainable use of natural resources. He is a co-author of the monograph Beyond Access (together with Tomme Young) (2007), which changed the international focus towards looking at user countries’ laws and policies to make ABS function. He has conducted studies in ABS in a variety of sectors (e.g. aquaculture, farm animals, forests and micro-organisms) and how these areas relate to ABS and IPR. One of his current interests is the establishment of a supranational global patent system outside national sovereign control. [email protected] Peter-Tobias Stoll is a professor of public law and public international law at the Georg-August-University of Goettingen. He is Director of the Institute for International Law and European Law. He earned his PhD in Kiel in 1993 and habilitation in Heidelberg, 2001. He is a junior researcher at the Walther Schücking Institute in Kiel and a senior research fellow at the Max-Planck-Institute for Foreign, Public and International Law in Heidelberg. He provided legal consultancy to German delegations in CBD and FAO negotiations. He has released publications in the area of international environmental and economic law. [email protected] Sélim Louafi is a senior research fellow at the Centre International de Recherche Agronomique pour le Développement (CIRAD, Montpellier) working on the governance of genetic resources for food and agriculture. He is an agronomist by training and has a PhD in agricultural economics. He has previously served as a senior officer at the secretariat of the ITPGRFA in charge of the implementation of the multilateral system of access and benefit sharing. [email protected] Thomas Greiber is a senior legal officer at the IUCN Environmental Law Centre (CEL) in Bonn, Germany. He holds a law degree from the University of Cologne Law School and an LLM in international environmental law from George Washington University in Washington D.C. Thomas has published in different fields of international environmental law and policy. He is the lead editor and a co-author of the IUCN Explanatory Guide to the Nagoya Protocol on Access and Benefit Sharing (Gland, Switzerland 2012). [email protected]

Notes on contributors

xix

Tianbao Qin is Professor of Law, and Associate Dean for Research and International Affiliations for both the School of Law and the Research Institute of Environmental Law, Wuhan University. He is an advisor for the Ministry of Environmental Protection, the Ministry of Agriculture of China and Chinese Delegation to negotiations on biodiversity and climate change issues. Dr. Qin is also the Secretary-General of the Chinese Society of Environmental and Resources Law. tianbaoq@ hotmail.com Tom Dedeurwaerdere is Director of the Biodiversity Governance Unit of the Centre for the Philosophy of Law (http://biogov.cpdr.ucl.ac.be) and professor at the Faculty of Philosophy, Université Catholique de Louvain. He is a graduate in engineering and philosophy, with a PhD in the philosophy of science. [email protected]

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Foreword

The experience gained in twenty years of implementing the Convention on Biological Diversity has laid the basis for an important evolution in perspectives now taking place. The apparent simplicity of the access and benefit-sharing concept – premised on a case-by-case transaction between a provider and a user of genetic resources – in many cases overlooked the complexity of implementation, while outstanding issues related to legal certainty, misappropriation and misuse necessitated the recent adoption of the Nagoya Protocol. First-generation access laws are being re-examined. Countries providing genetic resources are balancing their expectations for monetary benefits with the aim of capturing non-monetary or in-kind benefits in the short and medium-term. Countries hosting the primary users of genetic resources have recognised the need to prevent misappropriation and/or misuse, and to assist in ensuring the sharing of benefits. What’s more, the Nagoya Protocol while re-affirming the accepted principle of sovereign rights over genetic resources innovatively recognizes that in some circumstances taking a common approach to access and benefit-sharing issues may be useful to achieve its ultimate objective of fair and equitable benefit-sharing. This is why ‘Common pools of genetic resources’ is particularly timely and most welcome. It surveys and presents a wide-range of theory and practice on the concept of common pools of genetic resources and traditional knowledge. It spotlights examples of where common-pool approaches are already being successfully implemented at community-level and where they are being considered at national and regional levels. It further suggests areas where common-pool approaches might be applied in global contexts as well. ‘Common pools’ will provide new perspectives to assist policy-makers and stakeholders tasked with implementing the Convention, the Nagoya Protocol and other international agreements such as the Law of the Sea Convention and will facilitate innovative “outside-of the-box” thinking

xxii

Foreword

necessary to achieve the international community’s goal of fair and equitable benefit-sharing. Lyle Glowka Secretariat of the Convention on Biological Diversity, United Nations Environment Programme

Preface

The Convention on Biological Diversity (CBD) strives for the sustainable and equitable utilization of genetic resources, with the ultimate goal of conserving biodiversity. The editors’ book of 2009 entitled Genetic Resources, Traditional Knowledge and the Law. Solutions for Access and Benefit Sharing explored the bilateral model suggested by the CBD, which has since been elaborated by the Nagoya Protocol (NP) – will come into force on the ninetieth day after the date of deposit of the fiftieth instrument of ratification, acceptance, approval or accession. It was found that the exchange, ‘genetic resource for benefit sharing’, could have disappointing results because providers are left out of the process of research and development, it is difficult to trace benefits to sources, and providers owning the same resource may complain of being excluded from benefit sharing. Thus, the CBD objective of full utilization and equitability may become flawed. The present book suggests common pools as a complementary approach to bilateralism. Taking an inductive approach, it describes existing pools and analyzes how they are organized and how they perform in terms of joint research and development (R&D) and benefit sharing. It presents case studies of the most characteristic types of common pools, including pools with a local, national, transnational and international scope and informal and formal institutionalization, covering wild and domesticated varieties. The overall objective of the book is to provide suggestions for further developing existing pools to cope with the requirements of the CBD and NP and, at the same time, to use the clauses these conventions contain to open up for commons approaches. The book comprises one of the outputs of a research project on common pools of genetic resources, carried out at the Forschungsstelle für Europäisches Umweltrecht (FEU) at the University of Bremen, Germany. We hereby acknowledge the German Research Foundation (DFG, Deutsche Forschungsgemeinschaft) for funding the research project. We would like to thank all authors for showing a strong commitment to ensure the success of this project. It cannot be forgotten that the intensive discussions on the subject of the book which took place during a workshop

xxiv Preface in Bremen on 15/16 September 2011 enormously challenged our thinking in a positive way and made a useful contribution in shaping and consolidating the focus of the research. We therefore take this opportunity to thank all participants of the workshop for their contribution, enthusiasm and encouragement. The workshop was made possible by the generous financial support of the DFG; hence we once again express our gratitude. We would also like to thank our FEU Secretary, Ms. Antje Spalink, for extraordinary assistance in numerous tasks involving the project, including workshop logistics and assisting with the style formatting of the manuscript. Likewise, our assistants, Ekaterina Nikolova, Nhi Nguyen, Vladimir Bogoeski and Max Schwartz, deserve appreciation for their hard work in varying capacities during the different stages of the project. Bremen, 30 October 2012 Evanson Chege Kamau and Gerd Winter

Abbreviations and acronyms

ABNJ ABS ACM ACRN ACTA AFSA ANDES AnGR ANSWER ANVISA APEC APROTAC AqGR ASARECA ASEAN ATCC AUD AVRDC BABS Regulations BAPNET BBNJ

BC BCP

areas beyond national jurisdiction access (to genetic resources) and benefit sharing Asian Consortium of Microbiological Resources Asian Cassava Research Network Anti-Counterfeiting Trade Agreement Association Française des Semences de céréales à paille et autres espèces Autogames Asociacion para la Naturaleza y el Desarrollo Sostenible animal genetic resources Asian Network for Sweet-Potato Genetic Resources Brazilian National Health Surveillance Agency Asia Pacific Economic Cooperation Asociación de Productores de Tubérculos Andinos de Candelaria aquatic genetic resources Association for Strengthening Agricultural Research in Eastern and Central Africa Association of South-East Asian Nations American Type Culture Collection Australian dollars Asian Vegetable R&D Center Regulations on Bio-Prospecting, Access and Benefit Sharing The Banana Asia Pacific Network Ad Hoc Open-ended Informal Working Group to study issues relating to the conservation and sustainable use of marine biological diversity beyond areas of national jurisdiction biological control Biocultural Community Protocol

xxvi Abbreviations and acronyms BIOTEC BS BSA BSF BT CACMS CAM CAMBIA CAMERA CASSOA CAVCA CBD CCs CCAC CC0 cDNA CDS CEBLAW CGEN CGIAR CGRD CGRFA CI CIAL CIAT CIMMYT CIP CITES CNA CNBB COGENT COP CPs CSIR CU DArT DDBJ

National Center for Genetic Engineering and Biotechnology (Thailand) benefit sharing benefit-sharing agreement benefit-sharing fund Budapest Treaty China Academy of Chinese Medical Science complementary and alternative medicine Centre for Applications of Molecular Biology in International Agriculture Community Cyberinfrastructure for Advanced Microbial Ecology Research and Analysis Civil Aviation Safety and Security Oversight Agency China Audio–Video Copyright Association Convention on Biological Diversity WHO Collaborating Centres Culture Collection of Algae at the University of Cologne Creative Commons Zero License complementary deoxyribonucleic acid coding sequences Centre of Excellence for Biodiversity Law Genetic Heritage Management Council Consultative Group on International Agricultural Research Coconut Genetic Resources Database Commission on Genetic Resources for Food and Agriculture Conservation International comité de investigación agricola local International Center for Tropical Agriculture The International Maize and Wheat Improvement Center International Potato Center Convention on International Trade in Endangered Species of Wild Fauna and Flora competent national authority Conference of the Bishops of Brazil International Coconut Genetic Resources Network Conference of the Parties contracting parties Council for Scientific and Industrial Research coordinating unit Diversity Arrays Technology DNA Databank of Japan

Abbreviations and acronyms DG DNA DNFS DOA DSMZ EA EAC EADB EAPGREN EBRCN ECCO EIA EMBL EMBRAPA EP EPC EPO ERL EU FAO FDA FEMS FGR G.A. res. GA GAP GB GBIF GEF GIAHS GIS GISN GISRS GM GmbH GPA GR GRFA GTLE H1N1 H5N1

xxvii

director general deoxyribonucleic acid Consortium of German Natural History Research Collections Department of Agriculture National German Collection of Microorganisms and Cell Cultures East Africa East African Community East African Development Bank Eastern Africa Plant Genetic Resources Network European Biological Resource Centres Network European Culture Collections’ Organisation Environmental Impact Assessments European Molecular Biology Laboratory Brazilian Corporation for Agricultural Research European patent European Patent Convention European Patent Organisation Essential Regulatory Laboratories European Union Food and Agriculture Organization of the United Nations Food and Drug Administration Federation of European Microbiological Societies forest genetic resources General Assembly resolution General Assembly [except Chapter 3] Global Pandemic Influenza Action Plan to Increase Vaccines Supply (Global Action Plan) governing body Global Biodiversity Information Facility Global Environment Facility Globally Important Agricultural Heritage Systems Geoinformation Systems Global Influenza Surveillance Network Global Influenza Surveillance and Response System genetically modified limited company Global Plan of Action for Animal Genetic Resources genetic resources genetic resources for food and agriculture Group of Technical and Legal Experts influenza A virus subtype H1N1 influenza A virus subtype H5N1

xxviii

Abbreviations and acronyms

Healers HOGRAN HPAI-A IARCs IBC ICG ICMBio IDA IHR IITCM IK ILCs IMF INBIO INGENIC INGER INIBAP INRA INSDC IP IPEN IPGRI IPHAN IPK IPRs IRRI ISPN IT ITPGRFA IUCEA IUCN IUPAC IVTM

Kukula traditional health practitioners Hoodia Growers Association of Namibia Highly Pathogenic Avian Influenza A International Agricultural Research Centres Ethiopian Institute of Biodiversity Conservation and Research International Coconut Genebank Instituto Chico Mendes de Conservação da Biodiversidade International Depositary Authority International Health Regulations Institute of Information on Traditional Chinese Medicine indigenous knowledge indigenous and local communities International Monetary Fund National Biodiversity Institute International Group for Genetic Improvement of Cocoa International Network for Genetic Evaluation of Rice International Network for the Improvement of Banana and Plantain National Institute for Agricultural Research International Nucleotide Sequence Database Collaboration intellectual property International Plant Exchange Network International Plant Genetic Resources Institute [now called Bioversity International] Brazilian Federal Agency for Cultural Heritage Protection Leibniz Institute of Plant Genetics and Crop Plant Research Intellectual Property Rights International Rice Research Institute Population and Nature Institute International Treaty on Plant Genetic Resources for Food and Agriculture International Treaty on Plant Genetic Resources for Food and Agriculture Inter-University Council for East Africa International Union for Conservation of Nature International Union of Pure and Applied Chemistry Influenza Virus Traceability Mechanism

Abbreviations and acronyms K2C LIFE LVBC LVFO MARA MARDI MAT MCC MCSC MDA MiGR MK MLS MMA MOSAICC MOSAICS MoU MTA NARO NARS NCBI NEMBA NGO NICs NIH NLM NP

NRMDC OECD OPEC OZCAM PD PGR PGRFA

xxix

Kruger to Canyons Biosphere Reserve Local Livestock for Empowerment of Rural People Network Lake Victoria Basin Commission Lake Victoria Fisheries Organization Majlis Amanah Rakyat Malaysian Agricultural Research and Development Institute mutually agreed terms microbial culture collection Music Copyright Society of China Ministry of Agrarian Development [Brazil] microbial genetic resources scientific or ‘modern’ knowledge multilateral system Ministry of Environment [Brazil] Micro-Organisms Sustainable Use and Access Regulation International Code of Conduct Micro-Organisms Sustainable Use and Access Management Integrated Conveyance System memorandum of understanding material transfer agreement National Agricultural Research Organization National Agricultural Research Systems National Center for Biotechnology Information National Environmental Management: Biodiversity Act non-governmental organization National Influenza Centres National Institutes of Health National Library of Medicine Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the Convention on Biological Diversity national repository, multiplication and dissemination centres Organisation for Economic Co-operation and Development Organization of the Petroleum Exporting Countries Online Zoological Collections of Australian Museums Pancreas Disease plant genetic resources plant genetic resources for food and agriculture

xxx

Abbreviations and acronyms

PIC PIP Framework

PNPIC PNPMF PROINPA PRO-MAÏS PS PSF R&D RDC RGBIS RMB RNA SA SADC SAGE SAHGA SATCM SAV SBC SC SCP SFD SFDA SGP SGSV SMTA SNP SNUC SUS TANSAO TCDBASE TCM TCMK TCMLARS The Association TK

prior informed consent The Pandemic Influenza Preparedness Framework for the Sharing of Influenza Viruses and Access to Vaccines and other Benefits National Policy of Integrative and Complementary Practices National Policy on Medicinal Plants and Herbal Medicines Promoción e Investigación de Productos Andinos Association pour l’Etude et l’Amélioration du Maïs permanent secretaries Program of Family Health research and development The Brazilian Legislation for the Registration of Phytomedicines Rice Genebank Information System Renminbi [Chinese currency] ribonucleic acid South Africa Southern African Development Community Strategic Advisory Group of Experts on Immunization Southern African Hoodia Growers Association State Administration of Traditional Chinese Medicine salmonid alphavirus Sarawak Biodiversity Centre steering committee The Standing Committee on the Law of Patents Sabah/Sarawak Forest Department State Food and Drug Administration Small Grants Programme Svalbard Global Seed Vault standard material transfer agreement single nucleotide polymorphism National System of Conservation Units Unified/National Health System Taro Network for Southeast Asia and Oceania Traditional Chinese Drug Database Traditional Chinese Medicine Traditional Chinese medicinal knowledge Traditional Chinese Medical Literature Analysis and Retrieval System Kukula Traditional Health Practitioners Association traditional knowledge

Abbreviations and acronyms TM TMK TMPs ToR TrEMBL TRIPS TWN UKM UM UN UNAERP UNCLOS UNDP UNESCO UNGA UniProtKB UPM UPOV UPWARD USD USDA-ARS USM UWOMJ WDCM WFCC WG WHA WHO WIMSA WIPO WSSD WTO

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traditional medicine traditional medicinal knowledge traditional medicinal practices terms of reference Translated EMBL Nucleotide Sequence Data Library Agreement on Trade-Related Intellectual Property Rights Third World Network Universiti Kebangsaan Malaysia University of Malaya United Nations University of Ribeirão Preto United Nations Convention on the Law of the Sea United Nations Development Programme United Nations Educational, Scientific and Cultural Organization United Nations General Assembly The Universal Protein Knowledge Base Universiti Pertanian Malaysia International Union for the Protection of New Plant Varieties Users’ Perspectives with Agricultural Research and Development United States Dollar United States Department of AgricultureAgricultural Research Service Universiti Sains Malaysia University of Western Ontario Medical Journal World Data Center for Microorganisms World Federation of Culture Collections working groups World Health Assembly World Health Organization Working Group of Indigenous Minorities in Southern Africa World Intellectual Property Organization World Summit on Sustainable Development World Trade Organization

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Introduction

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1

Common pools of genetic resources and related traditional and modern knowledge An overview Gerd Winter

Setting the theoretical stage This book is about the use of genetic resources (GR) and traditional knowledge (TK) associated with GR. Besides TK, it also addresses scientific or ‘modern’ knowledge (MK) related to GR. The use of GR and TK/MK for research and development (R&D) is socio-legally organized in many forms. The most common are ‘free appropriation and use’, ‘property and market’ and ‘common pools’. ‘Free appropriation and use’ allows for access without prior consent of the resource holder and for unlimited use.1 The concept has been used widely for many resources and in many regions. This was possible, because regulation by states and communities hosting the resources was either lacking or not adhered to. The Convention on Biological Diversity (CBD) and the Nagoya Protocol (NP) elaborated and encouraged the concept of ‘property and market’, which was a clear acknowledgement of states’ sovereign rights over their GR and of local and indigenous communities’ ownership over their TK, as specified by their domestic legal frameworks. This gives states and communities the right to regulate access to GR/TK and receive benefits drawn from them (‘access regulation and benefit sharing’ – ABS). This implies that ‘free appropriation and use’ is confined to national territories in which no state or customary law establishing ABS exists, as well as to the ocean areas beyond national jurisdiction. It is assumed that ‘property and market’ will foster research and development of GR and TK and stimulate states and communities providing them to conserve biodiversity. The major tool for achieving ABS is envisaged in the exchange between providers allowing access to GR or TK and users having to share benefits that arise from their use. However, this bilateral exchange, ‘genetic resource for benefit sharing’, may have disappointing results that miss the initial vision of equity and have adverse effects on the other two goals, that is, to enable research and

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development of GR/TK and conserve biodiversity. Equity may be prejudiced in two regards, which can be called ‘horizontal’ and ‘vertical’. In the ‘horizontal’ dimension of equity, that is, among states hosting the same resource and indigenous and local communities holding the same TK, the provider of the resource or TK is entitled to take all benefit shares, thus excluding the others which may be prompted to lower their access conditions in a competitive race to the bottom. In the ‘vertical’ dimension, that is, between providers and users, providers may forego benefit shares because of difficulties in monitoring the process of research, development and commercialization, if the process is – as is often the case – intertwined and lengthy.2 This may lead them to constrict the allowable uses, thus hindering the emergence of the very benefits that they wish to attract, and jeopardizing both sustainable uses of GR/TK and biodiversity protection (Winter 2009; Chapter 15). These deficiencies might be alleviated in the third socio-legal form of GR and TK/MK use: common pools.3 A common pool may very generally be defined as resources that are provided by resource holders for common use by a group of people. The common use of resources in our context means that resource holders cooperate in the preservation of their resources, and that providers and users of GR and TK/MK enter into cooperative R&D, allowing enhancement of their own capacity and sharing in the resulting non-monetary and monetary benefits. This means that providers of resources become users when participating in the R&D process, and users become providers by feeding their R&D results into the pool. In this way equity can be achieved in both the horizontal and vertical dimensions, research and development of GR and TK is enabled, and resources and incentives to preserve biodiversity are provided. Common pools of this kind are not new inventions but have existed for a long time. Examples include seed exchange systems, networks of botanical and zoological gardens, networks of microbial collections and biological databanks. However, commons – ideal as they appear to attain equity and free R&D for sustainable use and protection of biodiversity – are exposed to problems of construction. These problems are caused by the dilemma that commons must persist in individualist societies. The nature of this dilemma, however, differs under the so-called old and new commons. The major dilemma of old commons (such as in livestock grazing and marine fisheries) is the tragedy of overuse, that is, that free use may lead to overexploitation of the resource by free-riders. This effect is less important in new commons, that is, the exchange of GR and TK/MK, because, as for GR, natural resources are impaired hardly at all if small samples are taken for research and development, and, as for TK/MK, information cannot be exhausted (Hess and Ostrom 2007). New commons suffer from a different dilemma: that free use may prevent participants from supplying their own GR, knowledge and gain to the commons, thus impoverishing its stock

Common pools of GR/TK/MK: an overview

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(Halewood et al. 2012: 14ff.). This dilemma can be called a tragedy of under-supply for the commons. It is reinforced by the ABS system because resource holders are affirmed as proprietors and encouraged to make individual use of their rights,4 which means that they would opt for the ‘property and market’ concept. The dilemma could be solved by placing a duty on users to feed their own material, knowledge and gain into the pool, and by enhancing the participatory rights and opportunities of providers within the pool. In that way it may be possible to avoid the problem of under-supply for the new commons. As with the old commons, there is no tragedy (in the old sense of inescapable fate) for the new commons but the choice to establish appropriate rules. In conclusion, two perspectives of study appear to have emerged, one looking from ABS to pools and one from pools to ABS: The ABS epistemic community, grounded on the paradigm of ‘property and market’, is interested in pools as a means to solve some of the equity deficiencies. On the other hand, the commons epistemic community starts with the de facto communality of GR and TK/MK and its beneficial function for R&D. In that view, pools should rather be defended against ABS claims of individual providers in order to preserve their useful performance. But the community, of course, accepts the need to pay tribute to ABS requirements. While the contributions in this book can be grouped into those which tend to take the first perspective, and those which favour the second, 5 the book as a whole brings both views together considering that the CBD and NP, while opening themselves up to common pools, also insist that this should be consistent with the CBD/NP objectives, including the sovereign right of provider states to regulate access and ask for benefit sharing. Taking an inductive approach, the book strives to portray a variety of pools in order to understand under which conditions they develop and how they contribute to the equitable sharing of benefits, innovative sustainable uses of GR and, finally, to the conservation of biodiversity.

Structure and content of the book There are different ways of structuring a book on common pools of GR, TK and MK. One important dimension is the kind of resource included in the pool: •

• •

The GR may be ‘wild’, as, for instance, the forest produce of an indigenous and local community or state, or ‘cultivated’, for example, by farmers’ collectives or transnational breeders’ exchange networks. The pool may comprise collections of biological material or databases of GR-related information. The knowledge recorded in databases or other media may be ‘traditional’ or ‘modern’.

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•

The pooled GR or related TK/MK may be concerned with plants, animals, microorganisms or biological agents.

All these differences of content will influence the choice of the basic organizational concept and, if that is a pool, they will shape the structure and rules of the pools. Just to give a few examples: certain highly developed crops have been pooled in the formalized multilateral system of the ITPGRFA and many less developed landraces in informal seed exchange systems (Chapters 5 and 17). In contrast, fish for aquaculture is still very much organized in settings of ‘free appropriation and use’ or ‘property and market’ (Chapters 9 and 10). TK is largely pooled by oral tradition while MK is rather saved in databases and print media (Chapter 13). According to another dimension, pools can be structured by the level and nature of law regulating the pool: •

• •

•

Many pools are local and subject to customary law, such as traditional holders of medicinal knowledge in Africa and Brazil (Chapters 2, 3 and 4) and local farmers’ collectives in Peru (Chapter 5). Others have been – or it is proposed that they be – organized by states as in Brazil, Malaysia, China and Norway (Chapters 6, 7, 8 and 9). Many common pools of GR are transnationally organized, with transnational meaning that management is self-regulated by participants rather than governments and spans national borders.6 Two subcategories of transnational pools can be distinguished here: collections of GR and related knowledge which invite material and open use by anyone on the globe, such as botanical gardens, microbial collections and biological and genomics databases (see examples in Chapters 10 and 11) and networks or metastructures of collaborating collections (Chapters 12, 13, 14 and 16). Only very few pools of GR have been given an international law framework like the multilateral system of the ITPGRFA mentioned above (Chapters 15 and 17), or may emerge, such as a regional system for East Africa and a global system for GR in the marine areas beyond national jurisdiction (Chapters 18 and 19).

As the organizational dimension is somewhat less complex than the content-related dimension, we have chosen it for the structure of the book. This will be reiterated when the individual contributions are summarized. Looking at the overall results of the contributions, one of the first impressions is the great variety of pool design, which in a way justifies the bottom-up approach of the book. The variety concerns many issues, such as: • •

the kind of resource that is the object of the pool; the overall goal of the participants;

Common pools of GR/TK/MK: an overview 7 • • • • • • •

who is allowed, invited or even required to submit material and knowledge to the pool; the quality criteria the material and knowledge must fulfil; how the material and knowledge are maintained; whether the traceability of the material and the knowledge of their source material is ensured; who has access to the pool and under which conditions; the obligations that are imposed concerning the utilization of material and knowledge, and the sharing of benefits; how benefits flowing into the pool are allocated.

Individual contributions to the book As indicated, the book is structured according to the levels of law that provide a framework for common pools. These can be local customary law, national legislation, transnational rules and international law. Local approaches The section on local approaches encompasses studies on the pooling or other organization of traditional medicinal knowledge and local seed breeding. The local communities holding and fostering the GR and TK understand their resources to be socially embedded. They all face problems of competition with the modern commodified sector and with the possibility that the product of their experience and work will be used by the modern sector without benefit sharing. They strive to strengthen their organizational framework in order to cope with those challenges. In their chapter on ‘Common pools of traditional knowledge: the story of the Kukula traditional health practitioners of Bushbuckridge, Kruger to Canyons (K2C) Biosphere Reserve, South Africa’, Gino Cocchiaro and Britta Rutert present a case study that shows how the scattered and endangered knowledge of traditional healers has won new strength through the formation of a knowledge pool. The authors first describe the many challenges that the healers living in the K2C Biosphere Reserve have experienced, including the exploitation of their knowledge by researchers without being informed about its use and sharing of benefits, as well as difficulties of access to wild plants due to restrictive rules in nature reserves and competing unsustainable harvesting. With the assistance of UNESCO, the healers gradually formed an association that provided the framework for developing rules and practices on the mutual sharing of healing knowledge, training programmes, the compilation of a community protocol and the allocation of funds from monetary contributions. The customary law they practise concerning third party access to their knowledge is of particular interest. In principle, the healers share their knowledge on a reciprocal basis, expecting that those who receive it will

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also provide their knowledge or, if they are students, will commit themselves to become healers. Academic researchers are nevertheless allowed access, provided they disclose the nature of the research, ask for consent if the intent changes, and engage in sharing benefits in case of commercialization. These customary rules are supported by the South African legislation, which is, however, still waiting for more specific regulation, the Bushbuckridge case being regarded as a learning example. The authors illustrate the access practices by summarizing the negotiations between the association and a local cosmetics company concerning knowledge about medicinal plants for hair and skin nourishment. One agreement, among other clauses, prevents the transfer of any knowledge to third persons. A benefit-sharing agreement was postponed until such time that bioprospecting had led to a viable product. The authors conclude their chapter by highlighting the two major goals of the TK pool, that is, to maintain the sanctity of culture inherent in the knowledge, and to organize the transfer of the knowledge for benefits that secure the livelihood of their communities. In his chapter on ‘Common pools of traditional knowledge and related genetic resources: a case study of San-Hoodia’, Evanson Chege Kamau sheds new light on the often-told story of the southern African people of the San and their knowledge about the Hoodia plant and its use, highlighting the common pool aspects of the case. The author starts by explaining that ethnic San now live scattered over several states but that knowledge about the properties of the Hoodia plant, and notably its capacity to suppress appetite, is traditional and common to all of them. He describes the various steps taken by the San to claim a share in the monetary benefit from the use of Hoodia. This claim was furthered by the fact that the San gradually organized themselves transnationally, thus forming a kind of pool of stakes in the use of their TK. A major achievement was the conclusion of two agreements providing the payment of royalties, one with the South African Council for Scientific and Industrial Research (CSIR) which holds a patent on a biochemical compound of the plant, and the other with the Southern African Hoodia Growers Association (SAHGA). As of now, no other agreement has been reached with holders of patents on Hoodia except the one with CSIR. Based on this, Kamau evaluates the pool and its activities. Looking at ‘horizontal’ equity, he points to the successful endeavour of the San to include all scattered groups across state boundaries and to distribute funds for projects helping all of them. In regard to ‘vertical’ equity, Kamau acknowledges the organizational basis the San created in order to defend their interests, but also sees flaws, such as its failure to include more holders of intellectual property rights in Hoodia genes or derivatives. Finally, in terms of the conservation of biodiversity, he points to the commitment within the agreements to ensure sustainable use of the plant. This may trigger measures of conservation of the Hoodia plant, which has become endangered due to overexploitation.

Common pools of GR/TK/MK: an overview 9 In his chapter, ‘Reinventing traditional medicine: Pacari and its struggle towards health, environmental protection and benefit sharing’, John Bernhard Kleba starts by emphasizing the high relevance of traditional medicinal practices (TMPs) for complementary healthcare, especially for the poor and for the development of drugs. Kleba asks about the patterns of self-reproduction of TMPs, focusing empirically on Pacari, an association of indigenous and local communities in the Brazilian Cerrado struggling for the right to exercise and protect their customary practices. One of the findings is that TMPs are introducing modern concepts in a very selective way, maintaining their heritage of social institutions and a traditional health ethos. However, TMPs are threatened in three major policy areas: the health surveillance regulation has drifted them into illegality; the erosion of the biodiversity hotspot Cerrado and the enclosure of lands are subtracting the pool of medicinal plants; and the regulatory adjudication of ABS rights is failing to protect new uses of traditional knowledge. These pressures are counteracted by Pacari, with good bottom-up medicinal practices developed by the association (Pacari), sustainable extractivism and the publication of its common property knowledge. Outstanding achievements are the establishment of pharmacia vivas (living pharmacies) which serve local and poor communities, the conclusion of agreements with landowners to allow sustainable harvesting of medicinal plants, and the publication of medicinal knowledge, which was not only meant as an improvement of common knowledge but also as a defensive strategy of prepublication against claims for intellectual property. According to Kleba, the association can also serve to actively ask for benefit sharing concerning new uses of knowledge and plants that were obtained before the CBD came into force. In conclusion, Kleba highlights the fact that the Pacari association treats traditional knowledge not as something static but as permanently developing. He warns, however, that in spite of its relative success, all efforts remain fragile and thus depend upon strong partnerships and favourable changes in policy and law. In their chapter ‘Guardians of the seed: the role of Andean farmers in the caring and sharing of agrobiodiversity’, Mario Tapia and Brendan Tobin emphasize that, like wild biodiversity, agrodiversity is a fundamental source of human life, and that breeding by local farmers is crucial as a basis for ex situ collections and industrial seed production. Vital for the preservation and development of agrodiversity is the exchange of seeds among local farmers. The authors present three case studies of such exchange systems. One case is local markets and seed fairs in the Peruvian Andes. The transactions are characterized by a complex mixture of sales, barter, social reciprocity and redistribution. The local markets and seed fairs maintain the diversity of the products, though the authors warn that given the competition of high-yield seeds, the seed fairs would not survive without external assistance from NGOs and the state. The second case is what the authors call participatory plant breeding. Its location is Bolivia

10 Gerd Winter and the crop at stake is potatoes. The Bolivian National Institute for Agricultural Technology started a programme of collecting, selecting and improving local varieties in order to combat plant diseases and increase yield. This was implemented through cooperation between scientists and local farmers. Evaluating the case, the authors see positive effects because commercial interest in diverse varieties exists, thus contributing to their preservation. On the other hand, the breeding effect has not yet been as successful as needed in order to compete with high-yield varieties on the global market. The third case is an association of six communities in the high Peruvian Andes called ANDES, which concentrates on potatoes, having the dual aim of conserving their agrodiversity and ensuring local food security. The Potato Park, as the initiative is called, operates on the basis of customary law principles such as reciprocity and equilibrium. It has collected and partly repatriated more than 1500 varieties. It collaborates with the International Potato Center and is one of the first examples of a private organization including its PGRFA in the multilateral system of the ITPGRFA. From presenting the cases, the authors proceed to a more systematic analysis of how the local initiatives could be supported by national and international law, which commonly puts stress on them. One supportive way has been that Peru and Bolivia have relaxed the standards for certification of seeds, thus allowing local varieties to be admitted to the market. In addition, the services of local farmers will be rewarded by requiring that access is subject to their prior informed consent. Farmers’ rights could be a third mechanism, but the authors feel they would be too narrowly constructed if only securing monetary benefit sharing. Rather, they should be understood as empowering farmers to regulate their own ecosystem and use seeds in accordance with traditional practice. Such empowerment could be supported by establishing agrobiodiversity zones, a category of protection not yet provided in the IUCN list of protected areas. Peru is presently preparing a law to that effect. As Juliana Santilli explains in Chapter 6, similar measures are being discussed in Brazil. National approaches The pools or pool ideas assembled in this part are all framed or are under discussion to be framed by national law. The thrust of the issues raised in these chapters is how such frameworks could be used to improve the utilization of the GR and TK and ensure that benefits, including commercial benefits, are shared with the pool and with the provider of the resource. In her chapter on ‘Genetic resources common pools in Brazil’, Juliana Santilli first introduces a network of ex situ collections of plants including a Base Collection, the National Genetic Platform. Concerning in situ and on-farm cultivated resources, she observes that there are artisanal as well

Common pools of GR/TK/MK: an overview

11

as scientific networks exchanging seeds and animals, but that neither the legal status of wild nor cultivated GR is clear. This means that in most cases private landowners end up receiving the benefits of the genetic potential. Santilli considers how existing networks and market systems for seeds and farm animals could be transformed into common pools of ex situ and in situ/on-farm resources at national or regional levels. Looking at existing legal frameworks, she points to the multilateral system of the ITPGRFA, which, however, covers only a limited number of GR in the public domain. For pools of other GR, she recommends the creation of appropriate legislation on participation, cooperative governance and the sharing of benefits via the introduction of a tax on seed sales. Highlighting the need to protect centres of agrodiversity, the author looks further for an appropriate international legal basis. She proposes that these centres should be understood not only as hosts of GR but as cultural and social complexes. She suggests the use of the UNESCO Convention on World Cultural and Natural Heritage as a basis, mentioning that traditional foodways have already been accepted as a new category of protection. In addition, she recommends, like Mario Tapia and Brendan Tobin in Chapter 5, that a new category of agrodiversity landscape should be added to the IUCN list of nature protection areas. Brazil has already started to designate such areas by providing a specific seal, the so-called chancela. In his chapter on ‘Developing a common pools strategy for genetic resources for food and agriculture: a case study of Malaysia’, Gurdial Singh Nijar starts with the observation that the unimpeded use and exchange of GRFA is crucial for food security. Such practices deserve also to be respected in the context of the access and benefit-sharing concept of the CBD and NP. Nijar outlines the recent Malaysian draft law that will transform the NP into national law and highlights those clauses, which, by waiving the PIC requirement, open the bilateral model up for common pools of traditional farmers, research communities, and regional and global exchange systems. Focusing on the latter, he describes how the multilateral system of the ITPGRFA is implemented in national practice. Currently, there is a lack of specific national rules. Based on the assumption that the ITPGRFA is directly applicable in Malaysian law, Nijar discusses in detail the scope of the ITPGRFA provision which states that GR that are under the management and control of contracting states are included in the multilateral system. He recommends looking at the supervisory competences of the central state, which implies that the government-based Malaysian Agricultural Research and Development Institute (MARDI) is covered, but not, however, the highly autonomous universities or the plant collections of the federal states. He proposes that the national legislator should further specify what exchange systems should be included. Nijar goes on to show that, in addition to the ITPGRFA, Malaysian collections and R&D centres participate in a large number of regional networks, each focusing on specific GRFA. He

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discusses the International Coconut Genetic Resources Network (COGENT) in some detail and its problems in keeping the collection of germplasm and related knowledge up to date. He concludes by pointing to the fact that ASEAN is developing a common framework for ABS, which also includes common pool concepts. ASEAN may join forces by establishing its own regional clearing-house mechanism as well as a common fund for biodiversity conservation. Tianbao Qin starts his chapter on ‘Common pools of traditional Chinese medical knowledge in China’ with the observation that China, like other developing countries, is rich in traditional medicinal knowledge (TMK) but has so far not benefited from access by industrial users. He explains the ways in which traditional and modern medicinal knowledge are different. Regarding the pool character of TMK, the author relates that TMK in China has various holders spanning from families through local communities to the public at large. Some of the TMK is collected in books and databases; some lives as an oral tradition. The law does not give TMK a specific legal status but provides a general framework. Thus, state and local governments are constitutionally empowered to manage and develop TMK. While the ABS system has not yet been fully introduced, some elements of it are already to be found, such as in the requirement that access to research results of TMK by foreigners is subject to administrative approval. The author presents two cases where foreign companies have utilized Chinese TMK to develop, patent and sell medicine. This leads him to suggest that legislation should be introduced to clarify ownership in TMK, ensure benefit sharing and provide legal certainty. This is not to suggest that the author argues in favour of strengthening individual ownership. Rather, he proposes the formation of common pools of TMK which then set the conditions for access and benefit sharing. Such pools already exist but could be further developed. Qin distinguishes two kinds of such pools and presents examples of each. The first category is state owned pools, of which the Traditional Chinese Medicine Database System is an example. The system can be accessed on payment of an upfront sum that is used mainly to finance the system. Further benefit sharing is not required. The providers of the knowledge are not remunerated. They are not even registered by the system. The second category is pools run by non-state actors. One major example is the Encyclopedia of Classics of Traditional Chinese Medicine, which consists of a database on ancient medicinal books and documents. The documents can be bought in the form of e-books. No further benefit sharing is foreseen, nor any tracing and remuneration of knowledge providers. Qin concludes his chapter by developing ideas for improvements that clarify the ownership in TMK, bring the providers of knowledge into play and require users to share benefits. He suggests the introduction of ownership by local communities rather than individuals and families. For the management of their rights he considers the state as not acting as a trustee,

Common pools of GR/TK/MK: an overview 13 but rather recommends the formation of a collective organization following the example of the Music Copyright Society of China. In his chapter on ‘Common pools in aquaculture: exploring patent law, ABS and sui generis options’, Morten Walløe Tvedt discusses the legal frameworks for marine GR that should be developed for aquaculture. Using Norway as a case study, he shows that the present situation is such that free access for others to Norwegian raw genetic resources is allowed. Breeders, however, seek to control the further utilization of their breed by contractual agreement. But this is hampered because there is no sui generis intellectual property protection for marine animals; only the patenting of gene sequences is available. The author considers where to go in this situation, to more or less free access. He considers that the GR and knowledge about them, including inventions, could be pooled. For Norway to do this as a provider of wild GR, or breeders as providers of breed or inventions, a strong incentive would have to be built into the system unless the providers are considered to be altruistic players who are satisfied with fostering global innovation. The incentive could be the right to make use of the material and information contained in the pool alongside an obligation on all participants to feed their material and knowledge into it. A problem is, of course, how to deal with those who wish to commercialize the results of their research and development. The author discusses whether the example of the ITPGRFA could be used where, in the case of commercialization, benefits must be shared in certain ways with the pool. However, this would presuppose that an institutional framework is erected and a critical mass of GR and information is already available within the pool. Realistically, therefore, the author expects and even recommends that Norway should rather introduce a legal framework ensuring bilateral ABS. Transnational approaches ‘Transnational approaches’ imply pools and other structures whose activities involve actors across national borders, which are not organized within a formal legal framework but by the actors themselves, be they private companies, public research institutions or governmental bodies. These can be collections of material and databases as well as networks or metastructures of such collections and databases. The thrust of most chapters in this part of the book is to start with existing pools of, in most cases, cultivated GR and advanced MK, and ask how they can be made compatible with ABS requirements, especially with the need to make users share benefits with the pool and the providers of pool resources. The chapter on ‘Practices of exchanging and utilizing genetic resources for food and agriculture and the access and benefit-sharing regime’ by Sélim Louafi and Marie Schloen is based on empirical information from a multi-stakeholder expert dialogue. Most of the GRFA exchanged and

14 Gerd Winter utilized have already been domesticated while some still need input from wild relatives. A market and a pool approach of practices can be distinguished. The market approach implies that GR are exchanged on the basis of individual contracts between actors who traditionally just transfer ownership in the material for some payment that reflects the market value of the material but not the value of its genetic potential. Sometimes, the kind of allowed utilization is restricted. This approach is most common in relation to animal, aquatic and forest genetic resources. The pool approach implies that the genetic resource is exchanged without restriction between actors and utilized by them. This approach is most often taken concerning plant GR, microbes and biological control agents. The authors proceed to explore how these practices will be influenced if the ABS requirements are implemented. The stakeholders expect that the whole process of research and development, in which the provider and user side often change places, will become very complicated and subject to high transaction costs. This may cause users to utilize ex situ rather than in situ GR. There is also a risk that those GR whose survival depends on their permanent use (such as landraces) may wither away. Small users will be more affected than large companies. On the other hand, stakeholders concede that a clear legal framework of ABS will help in many provider states whose ABS policy is not yet conclusive. In a third part, the authors discuss the possibilities for overcoming the general stalemate. One is to improve the ABS framework by streamlining procedures, another is the creation of research and development pools, and a third is the establishment of multilateral systems decoupling benefit sharing from the individual provider states. In their chapter on ‘Global scientific research commons under the Nagoya Protocol: governing pools of microbial genetic resources’, Tom Dedeurwaerdere, Arianna Broggiato and Dimitra Manou discuss how current practices of sharing material and knowledge on microbes can be adjusted to the requirements of the ABS regime. The authors start with the observation that open sharing systems are in the interest of scientific progress, as well as biodiversity protection, but that they are dependent on conditions such as avoiding free-riding, quality assurance, etc. They distinguish between three models of how such conditions can be established: regulation by a central authority, market-like interactions and self-governance of the networks. Looking at the example of the World Federation of Microbial Collections, they show that self-governance can work, in particular by using MTAs with viral licences and come-back clauses for commercial utilization. They recommend that these clauses should be introduced by all other exchange systems in order to cope with the requirements of the NP. They also point to the fact that the NP is not exclusively committed to bilateral concepts but does encourage commons approaches. Notably, this is done by asking for non-commercial research to be facilitated. The authors suggest that this clause should be read

Common pools of GR/TK/MK: an overview 15 broadly to include research aiming beyond the protection of biodiversity and to encourage various kinds of sharing of non-monetary benefits, such as by joint ventures, training in bioinformatics, and preferential access to research results. The chapter closes by considering how the opening clauses on multilateral agreements can be used for the purposes of research commons. In her chapter on ‘Networks of ex situ collections in genetic resources’ Christine Godt studies collections of GR and networks of such collections, asking whether they respect or even support the objectives of the CBD and the NP. Taking three examples of such GR pools, the multilateral system of the ITPGRFA, the International Plant Exchange Network (IPEN) and the German Collection of Microorganisms (DSZM) as part of the World Federation of Culture Collections (WFCC), she looks into and compares the constituencies and participants of the pools, their accession and access conditions, and their rules concerning commercialization of GR and related knowledge. The author finds a wide range of divergent rules and practices. What they have in common, however, is their self-perception and actual performance as intermediaries between providers and users of GR, that is, neither providers nor users. As intermediaries they serve the public interest of both sides by preserving GR and collecting taxonomic information. Confronting this role with the CBD and NP, Godt suggests that they should be seen as specialized instruments, which according to Article 4, NP, are allowed to follow their own logic but must be consistent and even support the objectives of the CBD and NP. She observes that while the service function of the pools is already a (non-monetary) benefit shared with all stakeholders, there are also loopholes allowing benefits to accrue without their sharing being ensured. For instance, although IPEN excludes commercial research, it does not do so if the user is a university. DSZM does not take responsibility for benefit sharing in cases of access with commercial intent, and the multilateral system of the ITPGRFA, although it requires benefit sharing in case of commercialization, does so too leniently. Godt therefore suggests that the host states of collections should introduce legislation extending the responsibility of intermediaries to ensure fairness between providers and users. Gorch Detlef Bevis Fedder, in his chapter on ‘Biological databases for marine organisms: what they contain and how they can be used in ABS contexts’, highlights a crucial problem of the ABS concept, that is, traceability of the source of the GR in the often complex valorization chain down to final products. The tool he suggests exploring in this regard is the database. First of all, he gives an overview of GR-related databases, underlining that they, of course, primarily have the goal of managing the huge and ever increasing amount of data and making it accessible for R&D. Taking the example of a transgenic salmon with improved growth performance that can be used in aquaculture, he tests databases for the possibility of tracing the product to its sources. Two kinds of databases are

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consulted: one that makes it possible to trace the genetic construct introduced into the salmon to the source species, which in this case is ocean pout and a variety of salmon, and the other that provides information about where the source species occur, which shows that it is many widely dispersed states. The author then draws conclusions from his case study about the traceability issue. In terms of ‘horizontal’ equity, he regards databases as a suitable tool for identifying occurrences of GR and points to the fact that species often spread widely, beyond the borders of geographical regions, so that regional agreements on the basis of Article 11, NP may have difficulties in identifying ‘their’ GR. In terms of effective monitoring, or ‘vertical’ equity, the author is positive about the contribution that databases can make in this respect but adds some proposals for improvement, in particular concerning the harmonization and use of unique identifiers of GR. A major flaw of the databases as they are is, however, that while identifying potential source states they do not enable the tracing of products to individual samples and states where the samples were taken. Although this might be improved through enormous organizational effort, the author suggests that provider states should seek their benefits by participating in the globalized R&D process rather than in shares from the benefits specifically drawn from ‘their’ sample. In his chapter on ‘Knowledge commons, intellectual property and the ABS regime’, Gerd Winter starts with the observation that scientific knowledge on genetic resources, like most other scientific knowledge, widely enters the public domain. He finds this commendable in the interest of understanding and sustainably using biodiversity. The knowledge commons are, however, constricted by privatization claims. Winter discusses three of them that are most relevant in the GR field: copyrights, patent and breeders’ rights, and – as a more recent addition – ABS rights introduced by states providing GR. While copyrights concern the form of a set of information, patent/breeders’ rights as well as provider state rights are related to the content of the information, the former being tied to a developed state and the latter to a ‘raw’ state of the GR. Winter goes on to consider how the knowledge commons could be protected against privatization of the knowledge. Copyright claims could be mitigated by waivers and general licences as proposed by the Creative Commons movement. Patent/breeders’ rights claims could be relieved by restrictions of access by commercial users to GR, and also by restricting the preconditions for, and the extent of, these rights. In contrast, in relation to provider states’ ABS rights, the author suggests that provider states have an interest in vital common knowledge pools if they are enabled as participants to co-develop their own R&D capacity and thus share nonmonetary benefits. However, such interests are impaired if knowledge is taken from the common pool and privatized through patent/breeders’ rights and other forms of commercialization. Winter suggests three solutions that would secure the provider states (or more generally the

Common pools of GR/TK/MK: an overview 17 states hosting relevant GR) their share in commercial benefits. One is to establish a close monitoring of R&D processes, allowing any product to be traced back to its origin in a provider state. The second would entrust the database organizations with ensuring the sharing of commercial benefits. As this would involve substantial transaction costs and a fundamental reorganization of databases, the simpler but also more radical third solution would be a biodiversity tax. This tax would be due for the sale of products or services developed from genetic resources that were accessed under the CBD/NP regime. It would flow into global or regional GRspecific funds and be redistributed according to criteria that reflect the need to protect biodiversity in general but also the interest of resource states in generating income from their own resources. International approaches This part encompasses examples of pools that are set up (or it is proposed that they be set up) by international law and guided by international organizations. Following a discussion of the general international law framework for such pool systems, the first two case studies – on the PIP Framework and the multilateral system of the ITPGRFA – demonstrate how a strong global interest (in disease response and in food production), which has led to the formation of the pools, can be made compatible with ABS requirements. The third case study – pools on the basis of eastern African integration – illustrates the reasons for, and the possibility of, regional solutions for impasses resulting from ‘horizontal’ and ‘vertical’ inequity. Regarding the last example – a possible pooling of resources in marine areas beyond national jurisdiction – the topic is rather whether one should move from a situation of free appropriation to an ABScompatible pool. The international law stage for this part is set by Peter-Tobias Stoll in his chapter on ‘ABS, justice, pools and the Nagoya Protocol’. Stoll lays out the international law background to the major concepts of the utilization of GR. His standard is justice with a view to bringing benefits to developing countries. He observes that both the bilateral exchange based on sovereign rights and multilateral exchange based on the pool idea have been introduced in order to achieve fair distribution. However, the bilateral model is at risk of failure because of limited jurisdictional reach, lack of control capacity and weakness in provider countries’ bargaining power. Cooperative approaches may therefore ensure just solutions more effectively. Stoll distinguishes three types of approach: provider pools which strengthen the bargaining and control power of provider states, either by forming cartels or joining forces, especially in cases of transboundary GR; provider–user cooperation with a view to collaboration in research and development activities and sharing the resulting benefits; and pools which fully transcend the bilateral logic, such as the multilateral

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system of the ITPGRFA. The author concludes his chapter by looking at legal bases for such cooperation in the Nagoya Protocol, especially Articles 10 and 11. In her chapter on ‘The World Health Organization’s Pandemic Influenza Preparedness Framework as a public health resources pool’, Marie Wilke discusses a global network of national influenza centres and WHO collaborating centres which exchange influenza viruses and antivirus medicine. She describes how the network was challenged when, during the global avian flu crisis in 2007, Indonesia noticed that a foreign company had applied to patent a vaccine it had developed on the basis of Indonesian material and refused to provide more material to the network, claiming violation of the network rules. Indonesia then bilaterally shared its GR with another firm in exchange for participation in the development of medicine. In reaction to this case the Pandemic Influenza Preparedness (PIP) Framework was adopted by the World Health Assembly and provided by an organizational infrastructure. Although non-binding under international law, it is made binding by contract on the basis of standard material transfer agreements (SMTAs), one concerning the members of the network, the other involving non-members, in particular pharmaceutical companies. The Framework lays down the rights and duties of participants, especially concerning the exchange of raw material as well as vaccines and medicine developed on the basis of the Framework. It also asks for royalty-free licences, the provision of a percentage of the vaccines produced at no charge, and a fee contributing to the running costs of the system. Wilke then assesses the system in terms of its effectiveness regarding the sharing of resources and information and its equitability regarding benefit sharing – using access to needed vaccines as a benchmark. While in principle she commends the PIP Framework as a major step forward, she also identifies flaws – most notably, that the duty of commercial non-members to share vaccines and medicinal products as well as patent rights and system costs is not standardized but open to individual negotiation. The system also lacks sanctions in case of breaches of rules, such as if a participant transfers material to third parties without prior consent. The author concludes her chapter by exposing the PIP Framework to the ABS regime. She believes that the case of pandemics is special because it necessitates a joint and timely global effort, and because the result of this effort must be made available to the entire world, and especially the poorer countries. In a setting of ‘needs justice’ (as Wilke calls it) the ‘entitlement justice’ of the ABS system is misplaced. The provider state will benefit from its participation in the general exchange system, while its interest in a special individual benefit is set aside. This is also compatible with the ABS legal framework which contains an opening clause in Article 8b) of the Nagoya Protocol. In his chapter on ‘The multilateral system of the International Treaty on Plant Genetic Resources for Food and Agriculture: lessons and room

Common pools of GR/TK/MK: an overview 19 for further development’, Evanson Chege Kamau first explains the main features of this pool of GR for cultivation. He points to the problem of defining what GR are under the management and control of a contracting state, and the importance of proper notification of the GR by contracting parties. He explains who may or may not have access to the GR of the multilateral system, and what conditions for access and utilization are laid down in the standard material transfer agreement (SMTA), including a viral clause and rules on sharing non-monetary and monetary benefits. Evaluating the system, Kamau regards it as effectively serving the interests of provider states because the use of their material can be traced through the system. He also finds it to be equitable because it prevents one provider state taking all the benefits while other states may have contributed to the generation of the provided brand of seed. He also commends the system for allowing unlimited research and development. However, the author also has some critical comments. He deplores the small number of states that have notified their GR to be covered by the system. One of the reasons, he observes, is an imbalance concerning natural and legal persons located in jurisdictions of contracting parties: they are entitled to use the system, but they are not obliged (only encouraged) to include their GR in the system. Concerning the contracting parties, the author suggests that better mechanisms should be found to persuade them to more generously and expeditiously notify the realm of covered GR. One mechanism might be that the provider states and persons should be given a somewhat more privileged position when funds collected from the commercialization of the GR are distributed. On the other hand, the fact that monetary benefits must be shared at a considerable percentage of gross sales may discourage users from accessing the system altogether, particularly as the US exchange systems provide a less costly alternative by allowing free access without any benefit-sharing obligation. As a last point, Kamau identifies a weakness in that the line is unclear between intellectual property rights (IPRs) based on GR in the form received on the one hand and IPRs based on further developments of the GR. He ends with commending the system as a highly valuable example of a common pool, which should, however, be improved in certain respects. In his chapter on ‘Exploring bases for building common pools in Eastern Africa’, Evanson Chege Kamau underlines the rich biodiversity in the eastern African countries, and the fact that many of the GR are shared by several of them. He first discusses what effects the bilateral approach propagated by the CBD and further elaborated by the NP will have on the use of these GR and the sharing of benefits drawn from them. He illustrates this with the example of vernonia galamensis, an oil plant highly valuable for industrial uses (e.g. as a plasticizer) and medicinal treatment (e.g. for skin diseases). Although occurring in many other countries in East and also West Africa, Ethiopia, which is a centre of origin of the plant, entered into an MTA with a British company that foresees the sharing of

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non-monetary and monetary benefits. This leads Kamau to ask whether it is equitable that Ethiopia takes all shares. As a corollary, he doubts that the country is really capable of controlling the possibly complex downstream process of valorization of the plant, thus also losing on equity in the vertical dimension. The author goes on to confront the bilateral model with a multilateral concept which would make use of the opening clause in Article 11 NP for regional approaches. Such a concept could be designed to share benefits among resource states as well as provide a better logistical basis for tracing benefits drawn from the common GR. It could be developed in either of two organizational frameworks: the Eastern Africa Plant Genetic Resources Network (EAPGREN), which aims at improving GR exchange and uses, and the East African Community (EAC). Kamau describes the structures and activities of the two. He pleads in favour of EAC because of its firmer organizational infrastructure and the fact that with the already existing Protocol on Environmental and Natural Resources Management as well as the upcoming decision on East African Community Transboundary Ecosystems Management, it has or will have secondary legal acts that already address pool issues and provide grounds for further elaboration. The book closes with a chapter on ‘Common pools for marine genetic resources: a possible instrument for a future multilateral agreement addressing marine biodiversity in areas beyond national jurisdiction’ by Thomas Greiber. The author first points to the multitude of potential uses of marine GR living in the marine areas beyond national jurisdiction (ABNJ), that is, the high seas, the deep seabed and ocean floor, including its subsoil. The potential value is reflected in the recent increase in research and bioprospection as well as related patents. This has raised international awareness about the sustainability of uses and benefit sharing. One of the outcomes of the debate is a resolution in 2011 of the UN General Assembly that initiates a process towards a legal framework ensuring sustainable use of marine biodiversity including genetic resources and benefit sharing. Greiber predicts that, as in the Aichi negotiations that led to the Nagoya Protocol, a deal may be struck implying that conservation measures will find consensus on the condition that the sharing of benefits from uses is conceded. This means that GR in the ABNJ are, in a way, pooled with a view to allowing unlimited research and development on the one hand, and asking for benefit sharing on the other. Greiber then considers existing legal frameworks as a basis for such pooling. One could be the CBD plus NP but he interprets these conventions as not reaching beyond the national jurisdiction. Closer to the point would be a protocol under the UN Convention on the Law of the Seas (UNCLOS). While, as Greiber shows, access to GR would not fall under the regime of the Area because it is confined to access to mineral resources, it does qualify as one kind of freedom of use of the high seas and a general freedom to research for both non-commercial and

Common pools of GR/TK/MK: an overview 21 commercial purposes. These freedoms are at the same time limited by obligations to preserve resources and share non-monetary benefits, including research cooperation, publication of research results and knowledge transfer. Within this loose legal framework, various options for a new convention are imaginable. Greiber outlines some core issues which may bridge the gap between some industrialized countries that are satisfied with the status quo and the developing world that strives for benefit sharing: the conception of marine GR as a common concern of mankind, the scope of the regime to cover both non-commercial and commercial research, procedures for access to be laid down by flag states and setting environmental protection conditions, rules for equitable benefit sharing by the setting up of transnational material collections, data pools and collaboration requirements, as well as a flag state system of monitoring and compliance control.

Conclusions Surveying the variety of common pools it appears that the pool approach does provide opportunities to enhance R&D in the interest of biodiversity protection and generation of useful products. If the pools are to be further developed, two aspects should be kept in mind: that the diversity of forms warns against a ‘one size fits all’ solution, and that care must be taken to overcome the difficulties of construction and maintenance of pools. Concerning the diversity of forms, further work on a general categorization of pools is needed. Taking their primary objectives as major characteristic, the following types may be distinguished: 1 Grassroots pools (such as the Potato Park in Peru), which comprise ‘wild’ GR and scientifically untested TK. They aim at local services and are socially embedded. They are reinforced in order to defend themselves against competition from and exploitation by the modern sector. They are ruled by customary law but deserve a supportive framework of national legislation. 2 Stipulating pools (such as the Hoodia network of the San in Southern Africa and the Pacari association in Brazil), which bring together holders of GR or TK who wish to pursue their rights of benefit sharing. They can build up organizational capacity to trace products to provider states and ensure the equitable distribution of benefit shares among participants of the pool. They may also aim to publish their knowledge in order to prevent patenting by third persons, or strive to obtain intellectual property rights themselves. 3 Basic research pools (such as the network of botanical gardens IPEN, but also the worldwide public domain of taxonomic research and knowledge), which encompass collections, databases and print media on ‘wild’ and cultivated GR and related MK. They aim to enhance

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biological knowledge, primarily by understanding biodiversity and thus providing a basis for its protection and further use. They defend the public domain character of biological material and knowledge. However, considering that even basic research results (especially in genomics and microbial research) are suitable for patenting, they are under increasing pressure to become commercial. This entails problems similar to those of applied research pools. 4 Applied research pools (such as the multilateral system of the ITPGRFA), which contain collections of cultivated GR and related MK. They aim at cooperative R&D and serve as an infrastructure for commercialization including attaining intellectual property rights and developing marketable products. As they enable commercial benefits, they are under pressure from the ABS regime to ensure benefit sharing with providers of pool resources. This can, for instance, be done by giving the provider privileged status concerning the sharing of benefits. 5 Commercial development networks (such as the intercompany exchange networks concerning high yield animal, forest and plant GR), which are platforms of cooperation or market transactions between owners of GR and MK. They tend to avoid forming a pool in order not to lose commercial opportunities. With the upcoming ABS regime, they must, however, adapt to benefit-sharing obligations and will have to decide whether to form pools that collect and distribute monetary benefits, either as a separate organization or as part of a research and development pool. The legal basis for improved forms of pools could be Articles 4 (2) and (4), 10 or 11 of the Nagoya Protocol. But they can also be started as local, national or transnational initiatives which ripen over time to be embedded in an international treaty and organization only at a later stage of development. Furthermore, it may be advisable to abandon the clear distinction between the three basic concepts and instead suggest that common pools can be combined with elements of the models’ ‘free appropriation and use’ and ‘property and market’. This is particularly apparent if one considers the relationships between a pool and external actors. While socializing resources internally, pools often act as owners of their resources externally, excluding non-participants or entering into market-like transactions with them. Concerning the difficulties of construction and maintenance of pools, it is remarkable that in many of the analysed cases the problem of possible under-supply of the pool arise, both at the use and the provision end. At the use end of pools, users at times strive to take material or knowledge from the pool without providing R&D results and commercial benefits in exchange, thus acting as free-riders. At the provider end of pools, providers may prefer not to submit their GR or TK but rather enter into

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bilateral relations with individual users, because they do not anticipate benefits flowing to them from the pool. These problems of under-supply can arguably be solved by appropriate rules and their implementation. At the use end the obligation of users to share non-monetary and monetary benefits with the pool must be strengthened and enforced. In addition, the availability of intellectual property on GR, TK and MK should be confined to the final stages of the valorization chain, thus freeing R&D from restrictions at a premature stage.7 At the provider end, appropriate incentives for providers to participate must be elaborated and enforced. A crucial question in that regard is whether the actual provider should be granted privileges over other resource holders. If the answer is in the affirmative, it is crucial that mechanisms are available to track products down to an original sample and the location where it was taken from. Alternatively, and as a means of avoiding the potentially enormous technical and financial costs of such tracking, the right to benefit shares would be decoupled from the specific GR or TK and their provider. Resource holders would receive benefits according to appropriate allocation rules which can still reward those who are particularly supportive of the pool. Those pools which aim at R&D as such (types 1, 3 and 4) rather than the stipulation of benefit sharing or commercial development (types 2 and 5) could even be released from managing the flow of benefits, and especially from claiming and allocating shares in monetary gains. These shares could be managed by separate regional or global funds, covering a single resource or cross-cutting several or even all resources. The concept causing the least transaction costs would be a charge laid on commercial monetary benefits from products or royalties based on GR and TK. As suggested in some of the chapters, it seems that such a charge, if appropriately designed, could disburden the R&D common pools, bring about both ‘horizontal’ and ‘vertical’ equity, enable research and development of GR and TK, and provide knowledge and means for biodiversity conservation.8

Notes 1 One might be tempted to conceive GR and TK for ‘free allocation and use’ as a common heritage of mankind, but this would be misleading because the idea of commonness assumes the existence of rules on joint use and benefit sharing. 2 These difficulties will be alleviated by obligations on user states to ensure that access to GR/TK complies with provider state requirements, see NP, Articles 15–18. However, according to dominant interpretation, these obligations only concern the access to GR/TK, not however their utilization. Therefore, the user state does not have to check whether the research and development within its jurisdiction complies with the conditions set by the permit and/or the access agreement (Buck and Hamilton 2011: 52). This low level of obligation is also reflected in the 2012 proposal of the EU Commission for an ABS Regulation, which only requires checking whether a permit was obtained

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3

4 5 6 7

8

Gerd Winter and/or an access agreement was concluded (see European Commission 2012, Article 4). As an alternative, cartels of provider states have been proposed (Vogel 2007). However, while these may ensure better sharing of benefits they appear not to provide an appropriate framework for cooperation in R&D by providers and users. See as examples the agreements between Ethiopia and a British company on the plant vernonia galamensis (Chapter 18) and between Indonesia and a US company on an avian flu virus (Chapter 16). An example of the first group is the collection of traditional medicinal knowledge in China (Chapter 8); an example of the second is the multilateral system of the ITPGRFA (Chapter 17). On the concept of transnational rule making, see Dilling, Herberg and Winter 2010. This could be done by reconsidering the protection of discoveries, raising the thresholds for the patent preconditions of novelty, inventive step and utility, and shrinking the protective scope of a patent right. See Chapter 14; Rimmer 2008: 9. One might fear complications because of the large number of transactions that would be taxed. This is, however, not necessarily so because only a very small percentage of bioprospected ‘wild’ GR and TK lead to commercial gain (Cragg et al. 2012).

References Buck, M and Hamilton, C (2011) ‘The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the Convention on Biological Diversity’, RECIEL 20 (1), pp. 47– 61. Cragg, GM, Katz, F, Newman, DJ and Rosenthal, J (2012) ‘The impact of the United Nations Convention on Biological Diversity on natural products research’, Natural Product Reports, 29 (12), 1407–1423, DOI: 10.1039/ c2np20091k. Dilling, O, Herberg, M and Winter, G (2011) ‘Introduction: Exploring transnational administrative rule-making’, in Dilling, O, Herberg, M and Winter, G (eds), Transnational administrative rule-making. Performance, legal effects and legitimacy, Hart Publishing, Oxford, pp. 1–20. European Commission (2012) ‘Proposal for a Regulation of the European Parliament and of the Council on access to genetic resources and the fair and equitable sharing of benefits arising from their utilization in the Union’ 4 October 2012, COM(2012) 576 final. Halewood, M, Lopez Noriega, L and Louafi, S (2012) ‘The global crop commons and access and benefit-sharing laws: examining the limits of policy support for the collective pooling and management of plant genetic resources’, in Halewood, M, Lopez Noriega, L and Louafi, S (eds) Crop genetic resources as global commons: challenges in international law and governance, Routledge, London, 1–34. Hess, C and Ostrom, E (2007) ‘Introduction: An overview of the knowledge commons’, in Hess, C and Ostrom, E (eds) Understanding knowledge as a commons, The MIT Press, Cambridge, MA and London, pp. 3–26.

Common pools of GR/TK/MK: an overview 25 Rimmer, M (2008) Intellctual property and biotechnology. Biological inventions, Edward Elgar, Cheltenham, UK and Northampton, MA. Vogel, JH (2007) ‘From the “tragedy of the commons” to the “tragedy of the commonplace”: analysis and synthesis through the lens of economic theory’, in McManis, CR (ed.), Biodiversity and the law: intellectual property, biotechnology and traditional knowledge, Earthscan, London, pp. 115–136. Winter, G (2009) ‘Towards regional common pools for GRs – improving the effectiveness and justice of ABS’, in Kamau, EC and Winter, G (eds), Genetic resources, traditional knowledge and the law. Solutions for access and benefit sharing, Earthscan, London, pp. 19–35.

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Part I

Local approaches

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2

Common pools of traditional knowledge The story of the Kukula traditional health practitioners of Bushbuckridge, Kruger to Canyons (K2C) Biosphere Reserve, South Africa Gino Cocchiaro and Britta Rutert

Introduction The Kukula traditional health practitioners (healers) of the Kruger to Canyons Biosphere Reserve (K2C), also known as the traditional health practitioners of Bushbuckridge, South Africa, have cared for their communities’ physical, cultural and spiritual well-being through involvement in traditional medicine and cultural ceremonies for centuries. The healers hold various forms of traditional knowledge (TK) in relation to the uses of their local medicinal plants. The sharing and use of their TK is integrated in their customary law and regulated very closely within the community. However, the healers have been increasingly concerned about the use of their TK by others, who fail to acknowledge the customary laws that govern the knowledge. This chapter will detail the process in which a collective of traditional healers agreed to pool and then share their knowledge with a local cosmetics company on specific terms, ensuring that ownership of the knowledge rests with the healers and that the customary laws guiding its use and responsibilities to the communities and ecosystems within those laws remain intact. Kruger to Canyons Biosphere Reserve The K2C forms part of UNESCO’s World Network of Biosphere Reserves. Established within the framework of the United Nations Educational, Scientific, and Cultural Organisation’s (UNESCO’s) interdisciplinary Man and Biosphere Programme, biosphere reserves are regions where important ecosystems and protected areas lie next to human settlements and are created to conserve biodiversity and promote its sustainable use.

30 Gino Cocchiaro and Britta Rutert Biosphere reserves seek the development and participation of communities in the region through education, training and involvement in research and monitoring programmes. They bring together governments, private enterprise, non-governmental and community-based organizations to provide processes that incentivize the sustainable use of resources whilst strengthening possibilities for economic empowerment and growth.1 The K2C Biosphere Reserve bridges the Limpopo and Mpumalanga provinces in the northeast of the country and has an area of approximately 4,800,000 hectares. It is comprised of savanna woodlands, afromontane forests and grasslands. It is recognized as one of the largest biosphere reserves in the world and includes some of the richest biodiversity areas, including the Kruger National Park and Blyde River Canyon Nature Reserve.2 The K2C Biosphere Reserve is demarcated into three areas, which include a core area assigned to strict environmental protection, a buffer zone in which only activities associated with conservation objectives can take place and a transition zone where sustainable resource management is practised by local communities. The biosphere reserve is not only extremely biodiverse but also culturally diverse. Its buffer and transition zones are home to about 1.6 million people from different ethnic backgrounds and language groups. Population densities are high and growing. The density is one of the highest in South Africa and the southern African region, at approximately 150 people per km2 in the east and 300 people per km2 in the wetter west. The annual population growth rate is about 2.4 per cent. The average household size is 6.2 people. There are an estimated 112,125 households in the area distributed over 65 settlements (Municipal Demarcation Board 2004). The healers in the K2C area are the custodians of a unique set of physical, socio-cultural, medicinal and biological knowledge. However, they are currently faced with a number of challenges that have a negative impact on their ability to continue their way of life. Ability to access land on which medicinal plants are located is one of the greatest challenges facing the healers (Du Plessis 2012: 2). Though there have been a number of claims of restitution of lands by communities, permitted under Section 25(7) of the Constitution of the Republic of South Africa, much of the area’s land remains in the hands of those who were unjustly allocated land during apartheid according to race. Nature and game reserves, whether private or publicly owned, provide little or no access to healers though housing some of the richest areas of biodiversity. In contrast, communal land is generally controlled by local chiefs and though access to these areas is permissible, biodiversity is often negatively impacted by over-harvesting, grazing cattle and muthi (traditional medicine) hunters who collect large

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quantities of medicinal plants for sale in the markets of Johannesburg and Durban. Their inability to utilize medicinal plants is contributing to the already tenuous position of traditional healers of communities, which is brought about through wider availability of Western medicine coupled with a negative propaganda campaign against them, largely led by churches in the area, associating traditional healing with witchcraft. A further challenge facing the healers involved the scores of researchers visiting their region to take their TK but providing little detail on how the knowledge would be used. This continued utilization of the healers’ traditional knowledge without their prior informed consent or recognition of their contribution to its development, combined with a lack of regard for the values of reciprocity and the norms that have guided the use of the knowledge for generations, further undermines the role the healers play in healing their communities, maintaining their culture and conserving their ecosystems. However, there has recently been an emphasis placed upon community participation in decision-making processes to address the social and economic needs in the region, and the establishment of the K2C and its K2C Biosphere Programme has been heralded as an extremely positive opportunity for the region’s development. Communities in the region began to collaborate with local authorities to promote ecotourism and also began educational programmes to highlight the rich biological and cultural diversity in the area.

Formation of the Kukula Traditional Health Practitioners Association of Bushbuckridge Through the support of UNESCO, the K2C Biosphere Reserve Management Committee and Natural Justice – an NGO working with Indigenous peoples and local communities3 – together with the healers, developed a process to address the previously mentioned concerns and challenges facing the healers. The process began with a meeting in early 2009, in which a small group of about 26 healers from the region met to discuss their concerns regarding the illegal harvesting of medicinal plants from the K2C and to learn about legislation in international and national law to protect their resources and knowledge. Following this initial gathering, regular meetings were held with increasing numbers of healers to share their concerns, discuss their wider objectives, gain a better understanding of their rights as holders of TK and meet with government officials from conservation agencies. By the latter stages of July 2009 a little over 80 healers who had been part of the discussions over the preceding months agreed to form the Traditional Health Practitioners of Bushbuckridge Association, now known as the Kukula Traditional Health Practitioners Association (the

32 Gino Cocchiaro and Britta Rutert Association). This group has now swelled to over 300 healers. The Association was designed to address the concerns of the healers and call for support from the government to address these concerns. The Association has now achieved registration under South African law as a ‘non-profit organisation’. The Association consists of a management committee of 26 people, six of whom are part of the executive committee, elected on an annual basis by all members of the Association. The executive committee is able to make decisions on behalf of the healers when mandated by members and has functioned to assist the Association in engaging with other stakeholders in K2C, including business and government, and to coordinate the development and utilization of the biocultural community protocol (BCP).

The Biocultural Community Protocol (BCP) of the healers One of the strategies of the process adopted by the healers was the development of a BCP. A BCP is a community-led instrument that promotes participatory advocacy for the recognition and support for ways of life based on the customary and sustainable use of biodiversity, according to standards and procedures set out in customary, national and international laws and policies (Jonas et al. 2010: 102–112). In this sense, BCPs are community-specific declarations of the right to diversity and claims to social pluralism. Their value and integrity lie in the process that communities undertake to develop them, in what the protocols represent to the community and in their future uses and impacts (Bavikatte et al. 2010: 62). BCPs provide an opportunity for communities to interact with other stakeholders according to their identified values and priorities. Through a combination of advancing their endogenous development goals and referencing relevant international and national laws, communities are better placed to engage with the various stakeholders, such as government bodies and NGOs. Such a process also provides clarity to the users of communities’ customary laws regarding the use of their natural resources and TK. The BCP of the Kukula Traditional Health Practitioners of Bushbuckridge sets out their biocultural values and how they connect their communities, through their culture, to biodiversity; provides some detail of their traditional knowledge; lists the threats to their livelihood posed by biodiversity loss and the taking of their TK without the sharing of benefits; records how the community plans to improve conservation and sustainable use of medicinal plants; provides information for people wanting to access their TK and medicinal plants; and references the relevant national and international laws.

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Rules governing the TK common pool Background The Kukula healers have always used a system of ‘commons’ to share their TK. ‘Commons’ may be defined as ‘a particular institutional form of structuring the right to access, use and control resources’ (Benkler 2006: 60). In the case of the healers, their commons were controlled by the community using systematic rules that governed the use of particular resources. The common pool of the Kukula healers attempts to adopt many of these rules to foster the sharing of their biocultural knowledge and their customary laws. In creating the common pool, the healers have acknowledged that engaging with parties outside the community would require a different system of protection and governance, in which they seek to balance the various interests that arise through the use and sharing of knowledge. The healers regard their TK as belonging to their ancestors. Transfer of knowledge is passed down through family members or is learnt in training schools via healer (sangoma) to apprentice (thwasa). The healers will communicate with their ancestors through techniques, such as breathing, drumming or dancing or through dreams and prayer. This communication functions as a conduit to connect the healers and ancestors, thus promoting knowledge to a system of continuous connections and relations or an inalienable ‘object’ that ‘acts as a vehicle of bringing past time into the present, so that the histories of ancestors (…) become an intimate part of a person’s present identity. To lose this claim to the past is to lose part of who one is in the present’ (Weiner 1985: 210–227). Inclusion of knowledge in the pool For healers in the region, transfer and collection of traditional medicinal knowledge can be categorized into three systems: knowledge gained through participation in a training school (Imphande); knowledge gained through ‘private’ ancestors of the family ancestral lineage; and individually held knowledge gained through experience and the sharing of knowledge with other healers. Each of the systems includes relationships between healers, their ancestors and the environment. Irrespective of which system the knowledge is derived from, the healers are able to share knowledge, should they choose, within the informal network or commons of healers, leading to the further generation or innovation of knowledge. Therefore, the protection of this network was a key factor in the healers considering the development of their common pool. The development of the common pool of knowledge shared between the healers was developed through a process of extensive internal

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discussion, which included all members of the Association. The common pool does not consist of any written record of knowledge but an agreement between the healers that they will collectively share their knowledge with business or research if agreed upon by the members of the Association. Whilst this process took time and much debate, the outcome was demonstrative of a sense of trust in the Association and ultimately in the executive committee. The common pool is open only to members of the Association who are able to place TK in the pool, use and innovate on the knowledge themselves and receive benefits if it is utilized by external agencies. The healers as a group decide which types of knowledge they are willing to pool. These decisions are guided by their customary laws given that there are some types of knowledge which can not be shared with others outside the community. Access to knowledge in the pool Within the common pool, healers are able to utilize and innovate on the knowledge, drawing parallels to the system of sharing and transferring knowledge that already exists within training schools and communication with ancestors. Just as the utilization of TK was previously regulated by customary law, so too is the use of knowledge taken by healers from the common pool. Customary law is an intrinsic part of TK and at the same time an extrinsic system that regulates the communities’ moral and ethical behaviour, and access to and use of resources in their environment. In their BCP, the healers describe how their customary laws dictate that the provision of their knowledge to others should always take into consideration their ancestors and fellow healers or risk violating the ‘sanctity of their common knowledge’ (BCP of the traditional health practitioners of Bushbuckridge). Though the healers comment that they are able to share their TK, they assert that it can occur only after adequate consultations, on the basis of reciprocity, a fundamental principle of their customary laws, and on the terms set out in their BCP. To ensure that their TK is protected, the healers require persons who want to access their TK to abide by relevant customary and domestic laws and they indicate the methods by which they will provide free, prior and informed consent for the use of their TK. The healers agreed that the conditions for sharing their TK in any particular case depend on the proposed use of the knowledge. For example, the BCP of the healers states that if students wish to access the knowledge in order to become healers themselves, they need to set up a mentorship arrangement and pay a fee. In the case of an academic researcher, an application must be made to the Executive Committee with details of the exact nature of the research. If consent is granted it is on condition that if the intended use of the research were to change, further consent would be required. Any further use of the knowledge requires that

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the healers are acknowledged as its original holders and that they benefit from any commercialization. International and domestic legislation also regulate how TK may be accessed by outsiders to the group. The Convention on Biological Diversity (CBD)4 and Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization and benefit sharing5 have created a legal obligation for the prior informed consent of holders of TK to be sought prior to its access. Implementing the CBD, the National Environmental Management: Biodiversity Act6 (NEMBA) states that an outsider wishing to engage in bioprospecting must disclose all relevant information to the community and, on the basis of that disclosure, obtain the prior consent of the community for access to the resource or TK in question.7 This position is strengthened by the NEMBA Regulations on Bio-Prospecting, Access and Benefit Sharing8 (BABS Regulations) which also state that prior consent must be obtained from any indigenous community affected by the proposed bioprospecting. Benefit sharing Once the knowledge is pooled, any benefits from the use of their knowledge would flow back to the group as a whole, even if an individual healer previously held the knowledge. Domestic legislation reinforces the customary laws of the healers by providing for ‘the fair and equitable sharing of benefits arising from bioprospecting involving indigenous biological resources’ (NEMBA) and stating that the parties must have entered a benefit-sharing agreement9 (BABS Regulations).

Case study In 2011, the executive committee of the healers, with the support of the K2C Management Committee, approached a local cosmetics company, Godding and Godding (G&G). The company expressed an interest in bioprospecting some of the traditional knowledge of the healers and possibly developing a new line of cosmetics. After internal deliberation amongst the healers they agreed to hold a first round of negotiations with G&G based on the terms contained in their BCP. G&G was seeking access to the TK of the healers in relation to skin and hair treatment and an agreement to be able to perform tests on this knowledge. Based on these tests G&G wanted to identify the most efficacious TK, which they hoped would lead to product development. The Association indicated their willingness to provide G&G with their TK for initial testing but expressed concerns as to how their knowledge would be protected. The negotiations proved to be successful and the parties agreed that they would form two sets of agreements. The first

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would be a confidentiality and use-restriction agreement, and the second a benefit-sharing agreement should G&G wish to develop a product. In April 2011, a series of meetings with the executive committee and all members of the Association were held. During these meetings, which were facilitated by Natural Justice and the K2C Management Committee, the draft confidentiality and use restriction agreement was presented, discussed at length and agreed upon. Confidentiality and use-restriction agreement The healers first agreed to pool their knowledge in relation to medicinal plants that might contribute to hair and skin repair or nourishment. This knowledge was then provided to G&G during a number of group meetings, on the basis that individual healers would not have any claim over the knowledge provided. G&G also agreed not to transfer any of the knowledge, and that they would provide regular updates of the results of research (i.e. what tests were completed, which, if any, were successful and what knowledge was used) and acknowledge that ownership of all knowledge obtained vests in the Association. To ensure that the parties to the agreement abided by its terms, the relevant South African law of contract was to be applied. Benefit-sharing agreement If G&G identified TK with market potential through its research then a benefit-sharing agreement would be entered into with the Association. The terms of such an agreement were not discussed; however, the executive committee of the Association did raise their interest in seeking nonmonetary benefits, such as a building that would serve as a place where they could hold graduation ceremonies for new traditional healers and which would also function as a clinic and a cultural centre.

Challenges and suggestions for improvement Given that the negotiations between the Association and G&G only began in April 2011, it is difficult to quantify the benefits and challenges of the process. It has clearly been advantageous for the Association to deal with a local company in G&G, which has allowed negotiations on fair terms and with adequate time. Many of the healers’ concerns could be alleviated due to the trust engendered between the parties throughout their joint discussions. After being brought to the attention of the Access and Benefit Sharing (ABS) Capacity Development Initiative for Africa, a multi-donor programme that aims to support relevant African stakeholders in developing and implementing national ABS regulations, has offered to

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assist with business and marketing support should G&G be able to develop a successful product based on the TK of the healers. The Department of Water and Environment Affairs of South Africa was also invited to attend meetings with the healers as they discussed the confidentiality and userestriction agreement. The Department viewed the negotiations between the Association and G&G as a test case for the national legislation and policy on ABS, as well as providing valuable information for their ABS Guidelines, which were being developed at the time. Though yet to arise, key challenges to the TK common pool are the protection of TK within the pool and the distribution of funds once received from benefit-sharing arrangements. Given that the TK common pool is an innovation for the healers, some reservations exist about sharing all knowledge in the pool. Currently, the TK common pool does not utilize national law to protect the knowledge amongst the healers but relies on customary law and a system of trust between the healers. Legal models, such as trusts, are being considered by the healers as mechanisms to maintain the integrity of the knowledge whilst engendering sharing within and outside the pool. Further, once benefits flow in the common pool, the healers would be required to set up transparent systems that provide a fair distribution of funds between members. In the current confidentiality and use-restriction agreement, G&G has agreed to regularly provide the results of the TK research to the Association. Though too early to assess, it is hoped that such an arrangement may provide the healers with additional possibilities in regard to innovation of their existing TK that they have not previously considered. This would potentially expand the TK commons to include G&G also. The agreement between the Association and G&G is the first of its kind in the region. It provides an excellent example for other communities that wish to engage with businesses in relation to the use of their traditional knowledge. The venture offers G&G, a local business, the opportunity to obtain national and possibly international acclaim as one of the first best practice agreements between a company and a local community for access and utilization of its pooled resources and knowledge.

Conclusion The TK common pool is a recent innovation that was developed to allow the healers to engage in benefit sharing with researchers and companies interested in utilizing traditional knowledge. Struggling to sustain their livelihood, preserve their identity and culture, and faced with increasing biopiracy of their traditional knowledge, the healers decided to form the Kukula Traditional Health Practitioners Association through the process of developing their BCP. The Association has supported its membership to address their concerns

38 Gino Cocchiaro and Britta Rutert and challenges through, among other things, the development of a traditional knowledge common pool. Creating the TK common pool required the community of healers to agree to share their knowledge. Though a commons has always existed amongst healers in the region, in which there were customary rules and norms that dictated how knowledge could be used and shared, provision of knowledge to those outside the community raised concerns about protection, use in an inappropriate way and recognition of the contribution of the healers to its innovation. The TK common pool continues to support the horizontal sharing of knowledge but provides restrictions on use outside the community. Importantly, access to the common pool may only be provided with the free, prior informed consent of the healers and they must also agree as to how the knowledge is used. This may be through the use of licences or contracts. The healers have been able to use this common pool system to engage with a local cosmetics company that is currently undertaking research and development in respect of the knowledge within the common pool. Should the company determine any market potential through their research, then it would be required to enter into an access and benefit-sharing arrangement with the healers, as obligated by international and South African law. The TK common pool of the healers has the dual aims of fostering the collective nature of TK ownership, therefore maintaining the sanctity of the customs, culture and values inherent in that knowledge, and allowing those owners to engage in benefit-sharing agreements that aim at securing sustainable livelihoods for the community.

Notes 1 2 3 4 5 6 7 8 9

http://www.kruger2canyons.com/learningcentre/kruger_to_canyons_biosphere. php, last viewed on 10 March 2012. http://www.kruger2canyons.com/learningcentre/kruger_geography.php, last viewed on 10 March 2012. http://www.naturaljustice.org Articles 8(j) and 15 of the CBD, 1993. Articles 7 and 12 of the Nagoya Protocol. Though adopted in 2010, the Nagoya Protocol will only become law once ratified by 50 parties to the CBD. Act 10 of 2004. Article 82. GNR 138 Government Gazette No. 30739 dated 8 February 2008. Sec. 8(1)(d).

References Bavikatte, K, Jonas H and Shrumm H (2010) ‘Community protocols and access and benefit sharing’, Asian Biotechnology and Development Review, 12 (3), 49–76.

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Benkler, Y (2006) The wealth of networks: how social production transforms markets and freedom, Yale University Press, New Haven. Biocultural Community Protocol of the traditional health practitioners of Bushbuckridge (2010) http://community-protocols.org/wp-content/uploads/ documents/South_Africa-Bushbuckridge_Biocultural_Protocol.pdf, last viewed on 8 January 2013. Du Plessis, E 2012, ‘Protection of traditional knowledge in South Africa: does the “commons” provide a solution?’, PhD thesis (draft version), Faculty of Law, University of Johannesburg. Jonas, H, Bavikatte, K and Shrumm, H (2010) ‘Biocultural community protocols and conservation pluralism’, Policy Matters 17, IUCN-CEESP, Malaysia, 102–112. Municiapl Demarcation Board (2004) http://www.demarcation.org.za/#, last viewed on 10 March 2012. Weiner, A (1985) ‘Inalienable wealth’, American Ethnologist, 12 (2) 210–227.

3

Common pools of traditional knowledge and related genetic resources A case study of San-Hoodia1 Evanson Chege Kamau

Historical background Much has been written about the San of southern Africa, originally called Bushmen2 (McGown 2006: 8; Wynberg and Chennells 2009: 91), and the Hoodia plant. Whereas the fascination of the narrative seems to override the critique of the excessive repetition involved each time the narrative is retold, we wish to focus on points which lay the foundation for a new analytical perspective of this narrative – the common pools perspective. The San are considered to be the oldest human inhabitants of southern Africa who lived in small nomadic groups of hunters and gatherers for thousands of years as the sole occupants of the region (Wynberg and Chennells 2009: 91; Mannetti 2011). They consisted of about 300,000 people when the settlers came to the region and occupied an area stretching from the Congo–Zambezi watershed in Central Africa to the Cape in South Africa (Chennells 2007; Wynberg and Chennells 2009: 91). Currently there are about 100,000 San (McGown 2006: 8; Mannetti 2011), living in Botswana (46,000), Namibia (38,000), Angola (7,000) and South Africa (6,000), with scattered populations living in Zimbabwe and Zambia (each 500) (WIMSA Brochure 2009). Of great significance for the San is Hoodia. Hoodia is a succulent, cactus-resembling plant that grows in the Kalahari desert in parts of South Africa (SA), Botswana and Namibia, where it is endemic. The San have traditionally used Hoodia and related species for different purposes. Most literature frequently refers to its use as an appetite suppressant. The San have used it in this manner for many centuries, especially during lengthy hunting expeditions where little food and water were available. In addition, they have used it to treat different ailments, to improve virility, to overcome hangovers, to increase crop yields, to protect seedlings against sunburn (Wynberg and Chennells 2009: 94), etc. Hence Hoodia’s significance is based not only on its importance as a source of livelihood for the San, but also because their traditional knowledge associated with Hoodia is tightly intertwined with it.

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Due to interaction with other indigenous peoples over the centuries as well as the wide distribution of Hoodia species in the region, the San’s knowledge on the uses of Hoodia is widespread. It has also evolved over time as other communities innovate on it. Today, this knowledge spans the borders of a number of southern African countries (Geingos and Ngakaeaja 2002), as the Hoodia species themselves do, and is used not only by the San but also other indigenous communities in those countries, including minority non-San groups (Munzer and Simon 2009: 835; Wynberg 2004: 861) such as Nama, Damara and Topnaar in Namibia (Wynberg and Chennells 2009: 94). The Namibian Damara, for instance, possess knowledge on the use of the Hoodia currorii species to cure diabetes, on the basis of which an international patent for the prevention and treatment of the same was filed (Wynberg and Chennells 2009: 95). All these peoples have a stake in both the plant and the knowledge, which cannot be considered as individualistic but rather communal (Munzer and Simon 2009: 835). There is therefore a de facto pool of Hoodia and knowledge about its use in southern Africa, which we generally refer to in this chapter as the San-Hoodia pool.

Figure 3.1 The distribution of Hoodia and occurrence of the San in southern Africa (source: Wynberg 2006)

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Stages in and structure of the formation of the San-Hoodia pool In 1963, the South African Council for Scientific and Industrial Research (CSIR) became aware of the traditional uses of Hoodia gordonii by the San from earlier publications (Wynberg 2004: 854f.; Gy. Duda 2005; Chennells 2007). On this basis, the CSIR started research and trials on the plant aimed at isolating its active ingredients, which it did not conclude due to limitations in technology (Wynberg 2004: 856; Gy. Duda 2005; Chennells 2007). In the 1980s, the CSIR revived its interest in the plant following the acquisition of new technology by its national chemical laboratories (Wynberg 2004: 856; Gy. Duda 2005) and isolated an active ingredient, a compound called P57. In 1995 it filed an application for a patent for the use of the compound’s properties responsible for appetite suppression (Wynberg 2004: 856; Joffe 2008: 19). The patent No. 198/3170 granted by the South African Patent Office has 132 claims, the scope of which covers both the process and the product (Bavikatte, undated). In 1998 the CSIR licensed P57 to a small British biotech company called Phytopharm (McGown 2006: 8; Gy. Duda 2005) that specialises in the development of phytomedicines (Kidd and Mayet 2003: 232). Phytopharm conducted double-blind clinical trials of the chemical and confirmed its appetite-suppressing qualities (Gy. Duda 2005; Wynberg and Chennells 2009: 95, 98).3 It then sub-licensed the product to the American-based pharmaceutical company Pfizer (McGown 2006: 8) for USD 21 million for development and commercialization (Wynberg and Chennells 2009: 95). All these deals were made, and continued and developed to an advanced stage, without any consultation with the San peoples (McGown 2006: 8), acknowledgement of their contribution or their prior informed consent (Chennells 2007; Wynberg and Chennells 2009: 100f.). As a result of lobbying by some organizations and the newspaper reports that followed concerning the commercialization of Hoodia, in 2001 the San became aware of the issue and of the registration of the Hoodia-based patent (Wynberg and Chennells 2009: 99). A vital development had taken place in 1996 which became a resource for the Hoodia case. In that year, San leaders had formed an organization known as the Working Group of Indigenous Minorities in southern Africa (WIMSA)4, to be an umbrella organisation of the San communities living in Botswana, Namibia and SA (Chennells 2007). The organization was charged with uniting and representing the interests of those communities (Chennells 2007). After regular cross-border meetings aimed at achieving a sense of solidarity among the different San groups, WIMSA secured a unanimous decision at its General Assembly (GA) in 1998, declaring San culture and heritage (i.e. all tangible and intangible aspects of culture, traditional knowledge, rock art, myths and music) as a collective asset, owned and to be shared by all San across boundaries (Chennells 2007). Therefore, when the developments with Hoodia became known to them

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they already had representation and had also made an important policy decision in regard to traditional knowledge on the uses of Hoodia. Thus, they engaged a lawyer who was representing them in land claim issues with the South African government under the same umbrella organization, WIMSA, to initiate negotiations for compensation to the San community. Mandated by WIMSA, the South African San Council entered into negotiations with the representatives of CSIR, resulting in the conclusion of a memorandum of understanding (MoU), which would lead to an ex post facto benefit-sharing agreement (BSA) of monetary and non-monetary benefits. An additional understanding was also reached that the San and the CSIR were the primary parties of the benefit-sharing agreement (Wynberg 2004: 861). Whereas the latter understanding was satisfying to the CSIR, which was concerned about the need to identify the genuine holders of traditional knowledge on the uses of Hoodia, it raised other questions on how fair and equitable such a benefit-sharing agreement would be if other communities that have traditionally used Hoodia, and countries where the plant is endemic, were excluded (Wynberg 2004: 861f.). It was almost certain that not all San groups had historically used Hoodia, only those living where it grows (Wynberg 2004: 862). However, precisely identifying those that did would have been a difficult task and one that had the potential of igniting quarrels in future (Wynberg 2004: 862). To avoid any divisions, and based on the decision taken earlier at the GA of WIMSA in 1998 (see above), it was agreed to include all groups. In 2003, a benefit-sharing agreement was signed between the San and the CSIR. According to the agreement, CSIR was obliged to pay 6 per cent royalties and 8 per cent milestone payments received from Phytopharm to the San (Wynberg 2004: 863; Gy. Duda 2005).5 Subsequently, the San reached an agreement on allocations of the benefits between San councils in each country and WIMSA. Overall, it was unanimously agreed by San representatives from Botswana, Namibia and South Africa during the WIMSA annual GA in October 2003 that 70 per cent of the benefits should go to development projects and 30 per cent should cover the administration costs of the San Councils (WIMSA 2004). Jointly with the CSIR, the San also established as well as registered the San-Hoodia benefit-sharing trust (fund) in 2005 (Wynberg and Chennells 2009: 99, 109). By the end of 2005, two milestone payments totalling about R 560 000 (~USD 100 000) were made into the fund.6 The publicity generated by the San-Hoodia case, the opportunities presented by the traditional San use of the Hoodia plant and the patent granted to CSIR greatly influenced the ensuing developments. As a consequence of the publicity, trade in Hoodia by plant traders – for herbal and dietary supplements – grew drastically and in most cases illegally and outside the San–CSIR BSA.7 This led to overharvesting,8 the exclusion of the San and country of origin, South Africa, from sharing benefits arising from such trade and, to a certain extent, free-riding on

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CSIR/Phytopharm’s research (Wynberg and Chennells 2009: 110; McGown 2006: 9). Today, many applications have been filed for patents based on Hoodia (see Table 3.1). Rapid growth in the Hoodia trade has also seen many herbal and dietary quarks (or imitations) enter the market, especially the North American market, which, in addition, raises an alarm concerning the safety and efficacy of such products (Wynberg and Chennells 2009: 110ff.). Increasing concerns raised by the high demand for the Hoodia species led to its inclusion in 2004 in Appendix II of the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) endangered species (Wynberg 2004; McGown 2006: 9), regulation of the Hoodia industry based on cultivation, and negotiations for benefit sharing (BS) between the South African San Council, mandated by WIMSA, and the southern African Hoodia Growers Association (SAHGA), which culminated in the signing of a BSA in 2007 (Chennells 2007; Wynberg and Chennells 2009: 112f.). The agreement acknowledged the San as the primary holders of traditional knowledge about Hoodia and, therefore, having a legal

Table 3.1 Some applications filed in the USA after the isolation of P57 by CSIR Number/Date

Owner/Inventor

Title

What is claimed

20050276869 15 Dec. 2005

Century Systems (Atlanta, GA, US)

Appetitesuppressing, lipase-inhibiting herbal composition

Hoodia gordonii with Cassia nomame, a Japanese plant

20050276839 15 Dec. 2005

Bronner, James S. (Atlanta, GA, US)

Appetite satiation and hydration beverage

Hoodia gordonii and other plant extracts in a beverage

20050079233 14 Apr. 2005

Phytopharm, plc (Godmanchester, UK)

Gastric acid secretion

Reducing gastric acid secretions with Hoodia

20040265398 30 Dec. 2004

Fleischner, Albert M. Herbal composition (Westwood, NJ, US), for weight control head of Goen Tech. Inc.

Hoodia, with or without other plant extracts, before meals to reduce appetite

20040234634 25 Nov. 2004

Council for Scientific and Industrial Research (Pretoria, South Africa)

Pharmaceutical formulations of Hoodia extracts and their use

Source: Based on McGown (2006)

Pharmaceutical compositions having appetite suppressant activity

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right to share benefits from the growing, harvesting and marketing of Hoodia (Wynberg and Chennells 2009: 113). It also acknowledged other groups holding TK about Hoodia (e.g. Nama and Damara) and foresaw their inclusion in BS through other agreements (Wynberg and Chennells 2009: 113). Recent developments depict a clear tendency towards a regional common pool. In 2009, a multi-stakeholder meeting was held with the aim of reaching a consensus on how relevant communal groups and countries could corporately deal with issues surrounding Hoodia. It was agreed, among other things, that all countries should be included in the process (Botswana had been excluded until then), all legitimate groups in the three countries should be identified and included in BS, and a common regional approach, which includes harmonization of relevant laws, should be forged.9 More consultations resulted in the signing of an agreement on 15 July 2009 between the San Council of Namibia (representing WIMSA) and the Association of Nama Traditional Leaders of Namibia which acknowledged that not only the San, but also the Nama have TK relating to Hoodia and other plants.10 In addition, the communities undertook to share future benefits other than the royalty negotiated with the CSIR11 and to work together in order to protect, preserve and utilize their TK for the benefit of their communities.12 Further, a benefit-sharing agreement was signed on 8 December 2010 between the San and Nama communities of Namibia and the Hoodia Growers Association of Namibia (HOGRAN) that recognized the rights of these communities to ‘fairly and equitably benefit from the harvesting, growing and sale of hoodia grown in Namibia’.13 One of the very interesting elements of the latter agreement is probably the formation of a constitutionally bound joint venture between the San and the Nama (SanNama) to ‘inter alia secure acknowledgement from the Government of Namibia with regard to their TK and indigenous knowledge (IK), negotiate with HOGRAN … and collaborate with all role players in order to advance their interests’,14 and also the mutual undertaking between the SanNama and HOGRAN to fully collaborate with each other and with the government of Namibia ‘with regard to any activities designed to market, brand, research, secure geographical indication, or to otherwise advance the hoodia industry in any manner’.15 If the agreement under these provisions materialize, ‘horizontal equity’ between the San and the Nama as well as ‘vertical equity’ between the SanNama and HOGRAN should receive a boost.16

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Table 3.2 Chronology of events shaping the San-Hoodia pool17 Date

Event

1936

First recorded use of Hoodia species for suppressing appetite, based on San knowledge

1963

CSIR includes Hoodia species in a project on edible wild plants, based on ethnobotany of the San

1983–1986

Acquisition of high-field nuclear magnetic resonance spectroscopy, allowing the relevant molecular structures of Hoodia to be elucidated

1995

A patent application is filed in South Africa by the CSIR for use of active components of Hoodia species responsible for suppressing appetite

1998

International patents are granted to the CSIR in some territories. Phytopharm sub-licenses Pfizer to complete clinical development, obtain regulatory approval, and commercialize. CSIR publishes its Bioprospecting Policy, declaring its commitment to sharing benefits with holders of traditional knowledge. However, in practice, this commitment is not implemented in the P57 project until 2003

1999

CSIR signs a Memorandum of Understanding with a group of South African traditional healers and begins implementing a system to document the use of traditional knowledge based on biodiversity

2001

Phase IIa / third stage “proof of principle” clinical trials18 for P57 reported to be successfully completed

2001

The Observer reports commercial development of Hoodia without involvement of the San. The San establish that a patent has been registered for CSIR based on Hoodia use, and that the CSIR has granted Phytopharm a license to exploit the patent. Negotiations between the CSIR and the San commence in the same month

2002

Memorandum of Understanding signed between the CSIR and the South African San Council, recognizing the San as originators of knowledge about Hoodia and including a commitment to benefit sharing

2002–2003

Negotiations continue between the CSIR and the South African San Council

2003

• CSIR and the South African San Council sign a benefit-sharing agreement • Pfizer withdraws from commercial development of P57

2001–2004

In parallel to the CSIR/Phytopharm initiative, a growing herbal market develops for Hoodia, using knowledge of the San to promote products. Some products are later revealed to be fakes, with no Hoodia content

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Date

Event

2004

• Phytopharm announces its intention to develop P57 as a food supplement • Proposal is tabled to list Hoodia as a CITES Appendix II plant, to allow for controlled commercial trade • Namibia announces its intentions to commercialize Hoodia • San apply for registration of the San Hoodia Benefit-Sharing Trust • Proposal to list Hoodia as a CITES Appendix II plant is adopted by the 13th Conference of the Parties to CITES. The CSIR announces the initiation of a broader bioprospecting project with the San • Unilever purchases the license from Phytopharm and commits an initial payment of $12.5 million out of a potential total of $40 million

2005

• Establishment and registration of the San-Hoodia benefit-sharing trust (fund) • Two milestone payments totalling about R 560 000 are made into the fund

2007

• Signing of benefit-sharing agreement between South African San Council and Southern African Hoodia Growers Association (SAHGA) • Acknowledgement in the agreement of other groups holding TK about Hoodia (e.g. Nama and Damara) and their inclusion in benefit sharing through other agreements

2009

• A multi-stakeholder meeting is held to seek consensus among relevant communal groups and countries and to decide how to corporately deal with issues surrounding Hoodia • An agreement is reached that all countries should be included in the process, including Botswana, which was until then excluded • It was agreed that all legitimate groups in the three countries should be identified and included in benefit sharing • It was agreed that a common regional approach be sought which include harmonization of relevant laws

2009

An agreement is signed between the San Council of Namibia (representing WIMSA) and the Association of Nama Traditional Leaders of Namibia on 15th July that recognized the rights of both communities over Hoodia as well as all types of benefits arising from its use and underlined the need to collaborate.

2010

A benefit-sharing agreement is signed between the San and Nama communities of Namibia and the Hoodia Growers Association of Namibia (HOGRAN) on 8 December

Note: Based on information from Wynberg (2004), Wynberg and Chennells (2009) Gy. Duda (2005), McGown (2006), Bavikatte (undated), Chennells (2007), Joffe (2008) and documents provided by, and communications with, Roger Chennells

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Lessons for pooling The San-Hoodia pool offers some useful lessons for the pooling of genetic resources and traditional knowledge at a community and regional level in terms of horizontal and vertical equity. In particular, the pool is exemplary in regard to horizontal equity as it has been gradually and increasingly growing in that area. Horizontal equity The San-Hoodia pool demonstrates a strong urge and effort to promote horizontal equity, that is, equity among the provider countries and communities. To date, two BSAs have been concluded with the San for the sharing of benefits arising from the utilization of their traditional knowledge associated with Hoodia. Initially, not all San groups and countries of Hoodia endemism were included in the benefit-sharing arrangement and decision-making about pertinent issues. Based on the binding decision of WIMSA that heritage is indivisible and that funds are to be shared equally among all San groups in countries represented by WIMSA (Wynberg and Chennells 2009: 106), a process to identify relevant stakeholders began, which has resulted in the inclusion of all relevant countries and San groups in those countries. In line with this, a process is underway to renegotiate the San-CSIR BSA in order to include all San groups.19 There have also been attempts to identify and include other legitimate stakeholders, including non-San communities that have traditionally used Hoodia, in benefit sharing through other agreements. Currently, Nama, Damara and Topnaar have been identified as such communities and could be directly included in the second BSA with SAHGA: the San-SAHGA BSA left open the possibility of further agreements to include other groups (Wynberg and Chennells 2009: 113) in benefit sharing. The trust has good principles that are exemplary for trust funds vis-à-vis equitability and effective functioning in distribution of funds among participants of a common pool. Accordingly, proceeds are to benefit all San groups20 and not to be paid to individuals. No distribution to a beneficiary community is acceptable unless a request formally approved by the trust sets out a detailed budget and coherent plan, identifies a bank account opened by selected representatives with a proper constitution and indicates the capacity to fully account for the proper expenditure of funds (Wynberg and Chennells 2009: 107). In addition, funds are to be used to attain the objectives of the trust, which include, inter alia, raising standards of living and the well-being of the San people in southern Africa (Wynberg and Chennells 2009: 107). There is still work needed though to realize some of the aims of the pool in terms of equity. This includes identifying all legitimate

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stakeholders, that is, groups that have traditionally used Hoodia for the same purposes as the San and countries of Hoodia-endemism, as well as involving them in decision-making and in the sharing of benefits.21 Moreover, de facto benefit sharing from SAHGA, which has yet to share any benefits with the San, still has to be realized. Vertical equity In terms of vertical equity, the pool has triggered the formation of networks which have unified as well as given a common purpose to the communities, leading to improved capacity and bargaining power in dealing with users and growers. It means that issues surrounding Hoodia, including access and benefit sharing, are no longer handled through individual negotiations with separate San groups. Thus, it has been possible to negotiate for more than just monetary benefits, for example, in the BSA with CSIR which foresees access to existing study bursaries for the San (Provision 3.7). The envisaged formation of a regional San council that will be fully representative of the San in southern Africa22 should further strengthen the capacity of the provider countries and communities. However, the interests of provider communities and countries are not sufficiently represented as users’ obligations are weak. The San-CSIR BSA, for example, is vertically inequitable vis-á-vis ownership of intellectual property rights. This is because the BSA excludes the San from coownership of the rights (Provision 4) even though they are based on the San’s traditional knowledge. There are also no opportunities and/or mechanisms for communities and countries of origin to draw on modern manufacturing technologies or uses, or growing and harvesting methods. In addition, there are basically no compliance measures in user countries to counteract illegal uses, biopiracy or inequitable practices. But negotiations with some user countries, namely Switzerland and Germany, are underway to improve control and compliance within their jurisdictions.23 Conservation and sustainable use of biodiversity Despite some weaknesses in relation to fairness, equity and effectiveness, the San-Hoodia pool depicts interesting features for conservation and the sustainable use of biodiversity. The benefit-sharing agreement between the San and the CSIR explicitly commits the parties to conserving biodiversity and undertaking best-practice procedures for plant collection (Provision 3.6). This shows that a collective approach to management of resources (or common pools) has the ability to promote their conservation and sustainable use.

50 Evanson Chege Kamau

Conclusion Although the San-Hoodia case portrays several deficiencies, it nonetheless possesses exemplary characteristic features, which make it a good model for both communal and regional common pools. There is a very strong urge to enhance fairness and equity between the provider communities and countries in terms of the keen effort to include all relevant stakeholders in decision-making and benefit sharing. That has been demonstrated in practice through identification of communities and countries that were initially not included in the first benefit-sharing agreement and meetings, respectively. The first benefits have been shared in a transparent way through unanimous decisions made under WIMSA. Apparently, all signs of unfairness and equity seem to come from the user side. First, the benefits shared with the provider communities under the San-CSIR benefit-sharing agreement are tiny. Second, CSIR’s monopoly claim on patents over the use of Hoodia (in exclusion of the San), which is based on the traditional knowledge of the San, is unfair. These issues need to be reconsidered and renegotiated to reward and include the San as far as their traditional knowledge is concerned. In terms of effectiveness, the effort to have all communities that have traditionally used Hoodia and countries of Hoodia endemism participate in the pool as well as contribute to its development is exemplary. The pool also possesses a functioning benefit-sharing fund with defined criteria on distribution and use of funds. Decisions are centralized through representatives and plans are underway for the formation of a single representative in the form of a San council for all of southern Africa. The duties of users are, however, weak, which means that the interests of provider communities and countries are not sufficiently represented. That opens the door for free-riding and limits the opportunities for countries of origin and relevant communities to gain from modern manufacturing technologies or uses, as well as growing and harvesting methods. Some user countries have demonstrated their readiness to improve control and compliance within their jurisdictions. Such measures, including ones made by other user countries, will have a great impact on improving the effectiveness of the San-Hoodia pool. Finally, the San-Hoodia pool is exemplary in terms of conservation and the sustainable use of biodiversity as depicted by the legal commitment of parties in the San-CSIR agreement to conserve biodiversity and undertake best-practice procedures for plant collection.

Notes 1

There is much written about the San and Hoodia, but there is little literature on the theme of this chapter. I am very grateful to Roger Chennells for

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2

3 4

5

6

7 8 9 10

11 12 13

51

providing me with documents and information without which this chapter would have been incomplete and also for taking the time to review a previous draft of the chapter. Originally referred to by a number of different terms, including ‘Bushmen’. In 1961, the word ‘San’ was first used by the Harvard Kalahari Research Group as a replacement for the term ‘Bushmen’ (Lee, 1976, as quoted by Chennells, 2007, fn 40). The word ‘San’ is accepted by the San leaders as the only known overarching term that describes their peoples (Hitchcock et al., 2006, as quoted by Chennells, fn 41). In a phase I trial, obese people were given P57 or a placebo, and the group receiving the active compound spontaneously reduced their daily food intake by 1000 calories. A non-governmental regional network representing San communities in the region in land matters at the time, WIMSA coordinates and represents the interests of San peoples throughout southern Africa. For more information about the network see http://www.wimsanet.org, viewed 23 October 2012. After this, in July of the same year (2003), Pfizer merged with Pharmacia and closed its Natureceuticals group that was responsible for the development of P57. It also discontinued clinical development of the drug and withdrew from its agreement with Phytopharm which meant returning the licensing rights to Phytopharm. Phytopharm was free to license P57 to other parties (see Wynberg 2004: 857). It is also said that Pfizer might have withdrawn from the agreement with Phytopharm, probably to protect the company’s image (Kamau 2011: 183, fn 26). Cf. Wynberg, R, Schroeder, D, Williams, S and Vermeylen, S (2009) ‘Sharing benefits fairly: decision-making and governance’, in Wynberg, R, Schroeder, D and Chennells, R (eds), Indigenous peoples, consent and benefit sharing: lessons from the San-Hoodia case, Springer, Dordrecht, pp. 231–257, p. 245f. and Wynberg, R (2008) ‘Access and benefit-sharing agreements in the commercial development of Hoodia’, in Laird, S and Wynberg, R, Access and benefit-sharing in practice: trends in partnerships across sectors, Technical Series No. 38, Secretariat of the Convention on Biological Diversity, Montreal, pp. 83–98, p. 91. CSIR held a patent on the Hoodia extract, which does not forbid other companies from selling the raw material for incorporation into herbal and dietary supplements. According to Wynberg and Chennells (2009, p. 110), annual trade in Hoodia rose from 25 tons in 2004 to 60 tons in 2006. See ‘Report: Hoodia multi-stakeholder meeting! Khwa ttu, January 22–23’ (2009) http://tkbulletin.files.wordpress.com/2009/02/hoodia_stakeholders_ meeting__khwa_ttu__report_final_draft1.pdf, viewed 23 October 2012. Roger Chennells, personal communication, 11 August 2012. The agreement of 2009 between the San and Nama communities in Afrikaans is not yet published but can be requested from WIMSA. The acknowledgement that not only the San, but also the Nama, have TK relating to Hoodia and other plants is reiterated in the 2010 agreement between the SanNama and HOGRAN (unpublished, with WIMSA), see Article 3.1. Roger Chennells, personal communication, 11 August 2012. SanNama constitution, Article 2.2 (unpublished, but can be requested from WIMSA). Benefit-sharing agreement of 8 December 2010 between HOGRAN and SanNama, preamble. The benefit-sharing obligation and plan are specified in Article 4 of the agreement as follows:

52 Evanson Chege Kamau 4. BENEFIT SHARING UNDERTAKINGS BY HOGRAN HOGRAN undertakes and commits itself and its members to the following 4.1

4.2

4.3

4.4

Where a sale of hoodia is carried out by HOGRAN, a royalty will be paid to SanNama as follows:a) 1% of the invoice value of the sale, where the entire sale is less than 1000 kg b) 5% of the invoice value of the sale, where the entire sale is more than 1000 kg. Where a sale of hoodia is conducted solely by the HOGRAN member, in other words a ‘private sale’, a royalty will be paid to SanNama as follows:a) 1% of the invoice value of the sale, where the entire sale is less than 250 kg b) 5% of the invoice value of the sale, where the entire sale is more than 1000 kg. The royalty will be owing prior to export of the hoodia, and payable at the latest on receipt of payment. HOGRAN will enlist the support of government to ensure compliance with this undertaking, pending legislation that will make such benefit sharing compulsory under the CBD. Members who do not comply with this will be disciplined and may lose membership of HOGRAN.

14 Benefit-sharing agreement of 8 December 2010 between HOGRAN and SanNama (unpublished, with WIMSA), Article 3.5. Generally, Article 3 should be seen as a tool for establishing equity between the different communities (‘horizontal equity’) as well as between them and other players in the hoodia industry (‘vertical equity’). 15 Ibid., Article 5. 16 For the use of these terms in this volume, see Chapter 1. 17 It is acknowledged that the chronology of most events is strongly influenced by the works of Rachel Wynberg and Roger Chennells, in particular Wynberg (2004) and Wynberg and Chennells (2009). 18 Third stage clinical trials are conducted at a later phase of the development of the active ingredient P57 which typically involve larger numbers of patients who are treated with doses and at durations representative of marketed use, and in randomized comparison to placebo and/or existing active drugs. They aim to show convincing, statistically significant evidence of efficacy and to give a better assessment of safety than is possible in smaller, short-term studies. A decision is made at this point as to whether the drug is effective and safe, and if so, an application is made to regulatory authorities for the drug to receive permission to be marketed for use outside of clinical trials. 19 See ‘Report: Hoodia multi-stakeholder meeting! Khwa ttu, January 22–23’ (2009) http://tkbulletin.files.wordpress.com/2009/02/hoodia_stakeholders_ meeting__khwa_ttu__report_final_draft1.pdf, viewed 23 October 2012. 20 The 75 per cent trust income for the San had to be divided equally among all groups, 25 per cent to be retained by the trust for internal and administration purposes and for allocation to WIMSA (Wynberg and Chennells 2009, p. 109). 21 It is, however, a near impossible task to identify (all) groups that have historically utilized Hoodia based on the background of resettlement,

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dislocation and movement of the San about the landscape over centuries and millennia, as Wynberg and Chennells (2009, p. 104ff.) correctly note. 22 Brörmann, M, ‘WIMSA’, CSQ Issue 26.1 (Spring 2002) ‘The Kalahari San’, http://www.culturalsurvival.org/ourpublications/csq/article/wimsa, viewed 11 January 2013.. 23 See ‘Report: Hoodia multi-stakeholder meeting! Khwa ttu, January 22–23’ (2009) http://tkbulletin.files.wordpress.com/2009/02/hoodia_stakeholders_ meeting__khwa_ttu__report_final_draft1.pdf, viewed 23 October 2012.

References Bavikatte, K (undated) Case study: South Africa. The hoodia plant, the San, and biopiracy, Regional ABS Capacity-Building Workshop for Eastern and Southern Africa, South Africa/India. Brörmann, M, ‘WIMSA’, CSQ Issue 26.1 (Spring 2002) The Kalahari San, http:// www.culturalsurvival.org/ourpublications/csq/article/wimsa, viewed 11 January 2013. Chennells, R (2007) ‘San Hoodia case. A report for GenBenefit’, www.uclan.ac. uk/genbenefit, viewed 23 October 2012. Geingos, V and Ngakaeaja, M 2002, ‘Traditional knowledge of the San of southern Africa: Hoodia gordonia’, presented at the Second South-South Biopiracy Summit: Biopiracy – Ten Years Post Rio, 22–23 August, Johannesburg, South Africa. Gy. Duda, V (2005) ‘Suppressed hunger, suppressed rights – On the protection of indigenous knowledge and the rights of the south African San regarding their traditional use of the Hoodia gordonii plant’, Dissertation, Universität Wien. Joffe, F (2008) ‘The hoo-ha about Hoodia in South Africa’, IP in the Life Sciences Industries, pp. 19–21. Kamau, EC (2011) ‘Common pools of genetic resources – a potential approach in resolving inefficiency and injustice in ABS’, in Feit, U and Korn, H (eds), Treffpunkt Biologische Vielfalt X. Interdisziplinärer Forschungsaustausch im Rahmen des Übereinkommens über die biologische Vielfalt (BfN-Skipten 289), BfN, Bonn, 2011, pp. 177–188. Available online at (last viewed 8 August 2012). Kidd, M and Mayet, M (2003) ‘Access to genetic resources in South Africa’, in Nnadozie K, Lettington R, Bruch C, Bass S and King S (eds), African perspectives on genetic resources: a handbook on laws, policies, and institutions, Environmental Law Institute, Washington DC, pp. 231–245. Mannetti, L 2011, ‘Understanding plant resource use by the ≠Khomani Bushmen of the southern Kalahari’, Master’s thesis, University of Stellenbosch. McGown, J (2006) Out of Africa: mysteries of access and benefit sharing, Edmonds Institute and African Centre for Biosafety, Edmonds, Washington. Munzer, SR and Simon, PC (2009) ‘Territory, plants, and land-use rights among the San of southern Africa: a case study in regional biodiversity, traditional knowledge, and intellectual property’, William and Mary Bill of Rights Journal, 17 (3), pp. 831–894, http://scholarship.law.wm.edu/wmborj/vol17/iss3/7, viewed 23 October 2012. ‘Report: Hoodia multi-stakeholder meeting! Khwa ttu, January 22–23’ (2009) http://tkbulletin.f iles.wordpress.com/2009/02/hoodia _ stakeholders _ meeting__khwa_ttu__report_final_draft1.pdf, viewed 23 October 2012.

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WIMSA (2004) ‘Biopirates in the Kalahari? How indigenous people are standing up for their rights – the experience of the San in Southern Africa’, http://www. wimsanet.org, viewed 23 October 2012. WIMSA (2009) ‘Who we are’ (Brochure), http://www.wimsanet.org, viewed 23 October 2012. Wynberg, R (2004) ‘Rhetoric, realism and benefit sharing. Use of traditional knowledge of Hoodia species in the development of an appetite suppressant’, Journal of World Intellectual Property, 7, (6), pp. 854–856. Wynberg, R (2006) ‘Identifying pro-poor, best practice models of commercialisation of Southern African non-timber forest products’, PhD thesis, University of Strathclyde, Glasgow. Wynberg, R and Chennells, R (2009) ‘Green diamonds of the south: an overview of the San-Hoodia case’, in Wynberg, R, Schroeder, D and Chennells, R (eds), Indigenous peoples, consent and benefit sharing: lessons from the San-Hoodia case, Springer, Dordrecht, pp. 89–125.

4

Reinventing traditional medicine Pacari and its struggle towards health, environmental protection and benefit sharing1 John Bernhard Kleba

Introduction This chapter investigates a case of collective political agency in relation to the stewardship of traditional medicinal (TM) knowledge, in which a network of about 80 Brazilian local initiatives of the Cerrado (the Brazilian savannah) are struggling for the right to exercise their medicinal practices.2 The main issue of this study is the question of how TM is maintained over time, shared and protected. The context of TM is addressed by discussing the shortcomings of regulatory frameworks in the areas of health, environmental protection and access and benefit sharing (ABS). In health policy there is an incompatibility between the legal call for valuing TK, anchored in various international laws (Dutfield 2006), and the shift of TM practices into illegality by health surveillance regulations. Regarding environmental protection, we learn from the case study that counteracting the strong biodiversity loss requires the engagement of indigenous and local communities (ILCs), but this aim can hardly be achieved without the support of policies and partners. Regarding the implementation of the Nagoya Protocol3 (hereafter the Protocol/NP) of the Convention on Biological Diversity (CBD), TM is challenging the ABS regime insofar as, depending on the design of national regulatory frameworks, a good share of the drug market could fall under the benefitsharing obligation, and compliance with ABS laws is still to be achieved.4 The first part of the chapter constitutes an empirical background. In the initial section, the Articulação Pacari (hereafter Pacari) and its participative research culminating in the publication of the Popular Pharmacopoeia is introduced.5 The chapter goes on to assess the policy areas of health and environmental protection. The case studies of two selected communities, Buriti and Cedro, are then outlined,6 depicting the ways in which they are organized. The second half of the chapter discusses core theoretical issues. It examines what is changing in TM practices and considers whether the new picture can still be defined as traditional. The conditions of self-reproduction of TM and its sharing patterns are

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appraised and we look at how shared TM knowledge is maintained by social institutions, organized as common property and threatened in many aspects. With the help of an empirical example, we show that core questions regarding the legal concepts of new uses and disseminated TK remain unsolved. Finally, the conclusion provides, with the help of the empirical findings, a critical account of the ABS regime.

Empirical background and policy shortcomings Pacari, the Pharmacopoeia and the community pharmacies Pacari is a non-profit organization established in 1999,7 currently linking more than 80 organized groups in communities spread over a diameter of 2,000 km across four states of Central Brazil8 (Articulação Pacari 2009: 37). The Cerrado is the most extensive savannah in South America with over 2 million km2, accounting for almost 24 per cent of the country’s area (ICMBio 2011). It is a unique biodiversity hotspot consisting of woodland/ savannah and dry forest ecosystems and supporting between 4,000 and 6,000 endemic plant species and a large numbers of birds, fish and mammals (CI 2011; ICMBio 2011). The expansion of soy, corn and ranching, the latter accounting for almost 40 million cattle, has reduced the original vegetation to one fifth of its original extent (CI 2011) (see Figure 4.1). Pacari`s groups work with traditional medicine (TM) and extractivism.9 They are groups of women, Quilombolas (self-established rural villages of slave descendants), indigenous peoples, Babaçu coconut breakers – a traditional economy of cracking the nuts for oil extraction – and land reform agrarian settlements. The TM of the Cerrado is a healing system based on the use of herbal medicine preparations, made in the form of potions, ointments, syrups, jellies, pills and oils, and may include diets, bathing, natural childbirth, blessings and clay therapy (Articulação Pacari 2009: 42; 44).10 Relying on public and private support and partnerships, the work of Pacari enables local pharmacies and income generating projects to start up and political and educational activities to be realized. Among the many sources of contribution, two that stand out are the Small Grants Programme (SGP) of the Global Environment Facility (GEF/ UNDP) and the Society, Population and Nature Institute (ISPN).11 At the local level, most of Pacari’s groups are supported by the Catholic Health Care Pastoral, rural workers associations or centres for alternative agriculture. In comparison to other social movements related to TM in Brazil, Pacari has distinguished itself by its original combination of local empowerment and policy working. For example, the initiative ‘Farmácias Vivas’ (living pharmacies)12 also established community pharmacies in the north-east of the country, but differently from Pacari; it has a stronger

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Figure 4.1 Map of the remaining vegetation in the Cerrado (source: Marcelo G de Lima, 2010, Program to combat deforestation in the Cerrado, Brazilian Environmental Ministry)

interest in links with research and development and is not concerned with TK rights. Pacari’s main targets are: a) advocacy for traditional medicines, with the introduction of good practice and the building of community pharmacies; b) the establishment of sustainable harvesting practices and

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policies towards access to land and biodiversity conservation; c) ABS rights; d) the self-organization of ILCs, including income generation; and e) the articulation of local demands in relation to law and policy (Articulação Pacari 2009). A highlight of Pacari’s work is a large research project conducted between 2001 and 2005, culminating in the publication of the Popular Pharmacopoeia of the Cerrado (Articulação Pacari 2009). The research was designed with participative methodologies involving a total of 262 people, among them popular researchers, healers and herbalists, and students (Articulação Pacari 2009: 61, 97). Sixty-two TM practitioners were interviewed, presenting a plurality of self-identities according to their work expertise and gender as raizeiros e raizeiras (herbalists (men and women)), parteiras (midwives), benzedeiras and curandeiros (folk healers), among others (Articulação Pacari 2009: 69). The participative research addressed medicinal practices, detailed information about recipes, including medicinal effects and toxicity, and the ecological context of the collected plants (Articulação Pacari 2009: 69). As a result, the Pharmacopoeia compiled a list of 264 medicinal species used by the traditional health practitioners of the Cerrado, providing information about 29 different types of ecosystems in which these plants occur (Articulação Pacari 2009: 86).13 From the plants listed, nine were selected for an in-depth study, similar to the standards of other Pharmacopoeias (Articulação Pacari 2009: 94). The Pharmacopoeia was the result of a legal and policy strategy to register and protect TM knowledge and to direct attention to the demands of the ILCs of the Cerrado. Consistent with this strategy, in 2006, Pacari applied for registration of the ‘Work of Raizeiros and Raizeiras’ at the Brazilian Federal Agency for Cultural Heritage Protection (IPHAN) as a good of intangible cultural heritage (patrimonio imaterial) according to Decree nº 3.551/2000 and Resolution no. 1/IPHAN/2006.14 Usually, Pacari’s groups have a community pharmacy or a very traditional house pharmacy.15 Community pharmacies were first established by the Catholic Health Care Pastoral, which since the 1970s, has encouraged the use of TM by populations with no access to doctors.16 Today, Pacari comprises a network of dozens of self-organized pharmacies. A survey made in three small regions of the State of Minas Gerais came to the conclusion that 31 community pharmacies assist about 7,300 persons per month (Articulação Pacari 2009: 44). The same sample depicts an average of 40 medicines and 70 used species per pharmacy (Articulação Pacari 2009: 44). Many communities have support from Pacari to build their own local pharmacy, with this concept spreading in Brazil.17 Health challenges There has been antagonism in politics and law between, on the one hand, promoting TM as a legitimate customary practice and, on the other hand,

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treating those practices as superstitious and dangerous. So, Pacari was created to mobilize against growing fears of an imminent prohibition of TM in Brazil. TM’s relevance today is beyond doubt. Even if the contribution of TK to pharmaceutical innovation has been occasionally overestimated (Dutfield 2011), its relevance has increased with a renewed interest in natural products as complementary to combinatorial synthesis (Laird and Wynberg 2005: 10). According to Dutfield (2011: 239), ‘the relationship between drug discovery and traditional knowledge is real yet more complex than most industry insiders and critics suppose’. TM is regarded as an additional option for the poor, being cheaper than modern medicines, accessible in remote places and culturally congruous. The World Health Organization (WHO) estimates that 70–95 per cent of the population of developing countries rely on traditional, complementary and alternative medicines (TM/CAM) for primary care (Robinson and Zhang 2011: 1). For cancer treatment, 89 per cent of Brazilian patients use the same TM/CAM (Robinson and Zhang 2011: 3). According to Abreu Matos, 80 per cent of the common diseases of low-income populations can be effectively treated with TM.18 In Brazil, a National Policy on Medicinal Plants and Herbal Medicines (PNPMF) was launched in 2006, including the aim ‘to promote and recognize the popular practices in using medicinal plants and homemade medicines’ (No. 10, Annex to Decree no. 5.813/2006). However, despite all arguments in favour of TM, the viability of those practices is severely obstructed by the regulatory framework of health surveillance, in Brazil represented by the Brazilian National Health Surveillance Agency (ANVISA). For example, the ILCs are not allowed to sell their own medicinal preparations, as selling herbal medicines is an activity restricted by expensive product registering, among other requirements. Although the above-mentioned Farmácias Vivas are allowed, within the scope of the National Health System (SUS), to perform the cultivation, collection, processing and storage of medicinal plants, and the handling of preparations, the marketing of the resulting products is forbidden (Article 1 of the Portaria no. 886, Ministry of Health). The labelling of preparations with medical information about dosage and therapeutic indications is also restricted to registered medicines (Carvalho 2011: 256–260). As a result, one of the interviewees reported a case of a community pharmacy being closed and a Pacari midwife being arrested. Commenting on this, a pharmacy leader pointed out: ‘This is bad, it even seems we were criminals.’19 Accordingly, ANVISA’s regulations run counter to Article 9, §4, of the Protocol, which states: ‘Parties […] shall, as far as possible, not restrict the customary use and exchange of genetic resources and associated traditional knowledge within and amongst indigenous and local communities in accordance with the objectives of the Convention.’ But what would be a reasonable balance between health surveillance requirements and customary rights in relation to TM practices?

60 John Bernhard Kleba The Brazilian legislation for the registration of phytomedicines (RDC 14/2010) is one of the most demanding in the world (Carvalho 2011: 91). The ANVISA considers as medicine only registered drugs and phytomedicines, excluding medicinal plants in bulk form and tea as food (Carvalho 2011: 256–260). Expectations of facilitating the practice of TM, for example, following the example of other countries like the remedio herbolario in Mexico, was frustrated (Carvalho 2011: 254, 215–216) and the newly passed resolution RDC 10/2010 of ANVISA allows only the simplified registration of dried leaves for infusions by certified laboratories, as notified plant drugs. These are meant to provide therapeutic ‘presumptions’, that is, as they rely on tradition and not on scientific standards of evidence, their use is restricted to less severe disorders (Carvalho 2011: 258–259). Interestingly, the challenges in relation to national policy and regulation listed by the WHO’s Traditional Medicine Strategy include general shortcomings in the recognition of TM/CAM, lack of training of practitioners in the field, inadequate allocation of resources and capacity building, and the need to address biopiracy (WHO 2002: 20–21), showing that these concerns are not particular to the Brazilian case. In fact, to promote safety, efficacy and quality of TM/CAM and its rational use (WHO 2002: 43–48), practitioners of ILCs ought to be given the opportunity to ‘develop their endogenous research capabilities to add value to their own genetic resources’ (Article 18, 4(d), NP). In this regard, the participative research used by Pacari in the making of the Pharmacopoeia of the Cerrado is a milestone to be followed. Beyond a merely ‘uninformed scepticism’ (WHO 2002), the difficulties in integrating TM in national health systems arise from industrial power, the centralization of decision-making and biomedical ideology. The corporative power of the life-sciences industry represents a highly concentrated and profitable health market, seeing in TM an opportunity to expand (Sawyer 2002). For instance, in China the value of market sales of herbal medicines amounted to USD 14 billion in 2005 and in Europe to USD 5 billion in 2003, the latter being underestimated according to WHO (Robinson and Zhang 2011: 6–7). In Brazil 52 per cent of all market revenues of the 119 companies producing phytomedicines in 2006 was generated by only five companies (Carvalho 2011: 198). Regarding participation, regulatory bodies like ANVISA have not been willing to open the decision-making process to include participation by stakeholders. 20 Finally, biomedical ideology is expressed in the notion that biomedicine is the only legitimate system of medical knowledge, the only one validated by science and strong regulatory requirements. This idea has been challenged by the more balanced concept of medical pluralism, according to which every knowledge system has its own strengths and deficiencies (Watson-Verran and Turnbull 1995; Baer 2004). Western

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biomedicine is no exception here, having made medical errors and scientific misinterpretations. 21 Regarding the shortcomings of TM practices of the Cerrado, they are better addressed by inclusive policies than by prohibition. Consistent with this concept, Pacari has been working to introduce good health practices adapted to the reality of ILCs. Pacari advocates ‘self-regulation’ of TM developed bottom up (Evangelista and Laureano 2007: 9). For this reason Pacari’s members take part in technical courses22 to learn issues about hygiene, contamination, durability and conservation techniques, measures and dosage systems, and adequate infra-structure (Articulação Pacari 2009: 48–51). All health practitioners have been required to track records of efficacy through user perceptions (Interviewee B, August 2011).23 In order to improve product quality, the acquisition of medicinal plants with unknown origin has been substituted by locally grown or collected resources (Interviewee A, August 2011). An additional issue concerns the weak integration of TM practices in the public Unified Health System (SUS). Since the establishment of the National Policy of Integrative and Complementary Practices of 2006 (Ministerial Rules No. 971 and No. 1.600 – PNPIC), the SUS is providing phytomedicines and medicinal plants in 340 municipalities.24 The SUS is, however, required to make available only medicines registered by ANVISA, excluding the largest part of Brazilian TM. Additionally, the astonishingly rich Brazilian TM is barely reflected in the system. From an official list of 237 medicinal plants used in the SUS system, 25 only 48 plants have their geographical origin in Brazil, being adapted or native, and only 11 exclusively in Brazil (Carvalho 2011: 74–82). From the 512 phytomedicines registered by ANVISA until March 2008, only around 10 per cent are based on Brazilian native species (Carvalho 2011: 69). Cooperation between the SUS and community pharmacies generally does not occur (Interviewee C, April 2012). A few exceptions to this will be revealed in the case studies described below. For Pacari, this gap between TM and the public health system represents a major constraint in making the work of traditional practitioners economically sustainable, since the contribution of TM is not made visible in the official statistics and is, therefore, not able to be rewarded by public health funding (Interviewee C, April 2012). Environmental policy Pacari is concerned with finding solutions to biodiversity erosion and the enclosure of lands, as both are threatening the collection of medicinal plants. The National System of Conservation Units (SNUC) (Article 21, Law No. 9.985-2000) has created public natural reserves, of which two types are particularly designed for the needs of traditional peoples: the Sustainable Development Reserve and the Extractive Reserve.26 The whole

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Cerrado today has a total of 25 federal reserves from which six are extractive reserves (Lima 2010), too few in the view of Pacari. Another concept developed in Brazil is the Free Access to Babaçu Coconut Law. The concept was first passed in municipalities in the State of Maranhão, aiming to preserve natural resources threatened by cattle-ranchers and seeking to assure rights to access lands with coconut forests, which received the status of common property (Cornwall, Romano and Shankland 2008).27 Free access to Babaçu is mainly a women’s movement and some of these groups joined Pacari. However, most groups associated to Pacari are far from any public reserve or common land. The solution found by these groups is to negotiate with landowners of the surrounding neighbourhood access to their legal reserves for plant collection. Legal reserves are prescribed in the Brazilian Forest Code.28 The current revised version of the Forest Code is Provisional Measure 2.166-67/2001, which states that a legal reserve is a protected area inside a rural property or land tenure, excluding special areas of permanent protection, in which vegetation cannot be suppressed (Article 1, §2, III). The sustainable use of these areas is allowed (Article 16, §2). For the Cerrado, the scope of legal reserves varies between a minimum of 35 per cent of the property area for those properties situated in the north of the 13th parallel south, and 20 per cent for the ones situated elsewhere (Article 16, PM 2.166–67).29 The interviews have shown that Pacari’s groups are having a significant role in encouraging farmers to comply with the provisions on legal reserves, in preserving or recovering areas. This is done locally with the help of a good neighbourhood strategy, which provides TM assistance in exchange for free access to land for extractive purposes. A major concern of Pacari is to establish sustainable extractive techniques in ILCs. The overexploitation of medicinal plants makes it difficult for herbalists to access resources and can even lead to the extinction of valuable species. Counteracting the widespread overexploitation of traders, who collect great quantities of plants for selling in larger cities, Pacari puts great emphasis on teaching techniques of sustainable management, that is, in how, when and what to extract in order to maintain a permanent stock of medicinal plants available over time (see Figure 4.2). The case of Buriti In the next sections, I will focus on two examples of ILCs engaged with Pacari in order to understand their context, organization and views on TM. The cases concern social movements in Buriti and in Cedro, both in the State of Goiás. Buriti de Goiás is a small city with 2,560 inhabitants and an economy based on agriculture and ranching.30 In Buriti a women’s movement

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Figure 4.2 Dona Eterna explains techniques of sustainable extractivism, Golden Mountain Range, Buriti, Goiás, Brazil, August 2011 (photograph by John B Kleba)

founded the ‘Farmacinha [pharmacy] do Cerrado’ in 2002. The women had worked since the mid-1990s with the Health Care Pastoral, but in 2002 they split to establish their own organization with the help of Pacari, aiming to achieve autonomy and develop economic opportunities. Today

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there are six women working at the Farmacinha (there were 15) and several more that come to the mutirões, that is, a traditional form of collective work based on solidarity (see Figure 4.3). In the Farmacinha of the Cerrado, the medicines are either sold for a small charge or exchanged for products – for example, brown sugar, honey, seeds and fruits – or given to people who cannot afford to pay. The income of the pharmacy and the small adjacent bookshop is modest, just enough to cover the fixed costs. The surplus of money and exchanged products is divided between the workers, and a small percentage goes to the coordinator. The motivation for the workers to engage in the group arises from the need for cheaper medicine, a belief in the advantages of TM and the desire to give continuity to family traditions. The Farmacinha offers about 40 preparations, of which the most in demand are for the treatment of diabetes, hypertension, bronchitis, parasitic worms, stomach ailments and anxiety disorders. From this sample, the medicines can contain from 6 to 22 different plants. About half of the sources are extracted from the Cerrado. As there is no public land available, they are extracted with the help of a partnership with two private legal reserves in the Serra Dourada, the Golden Mountain Range located 12 km out of the city. The other plants are cultivated in a medicinal garden alongside the Farmacinha.

Figure 4.3 Collective production of traditional medicines in the Farmacinha do Cerrado, Buriti, Goiás, Brazil, Aug 2011 (photograph by John B Kleba)

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The group points out that in the region biodiversity has decreased dramatically, and as a result they are demanding public conservation areas: ‘My dream is to have the Mountain Range with free access and nobody able to deforest it. The quarry there should be stopped’ (Interviewee B, August 2012). The quarry referred to is a group of open mines in which quartzite is extracted. According to the interviews, most of the local population has been using medicines from the Farmacinha and additional clients come from the region, occasionally even from cities far away. However, many local people would prefer to get medicines from the National Health System, the SUS, as these are free of charge. The Farmacinha and the SUS cooperated for four years during the last city government, when the Farmacinha provided medicines for diabetes and hypertension, apparently with a high degree of satisfaction among patients. The cooperation was stopped when a new mayor from the rival party won the election. Due to the legal obstructions to generating income from the commercialization of TM, Pacari has established a set of new projects with ILCs.31 One of these projects is the production of cosmetics by the Association of Ipês in Buriti. The first products, including soaps, lotions, shampoos and oils, were launched in 2008. The source of the cosmetics is the oil extracted from the Gueroba palm (Syagrus oleracea), which is native to the Cerrado and is used as human and animal food and as medicine. Over 40 family farmers supply the Association of Ipês with palm nuts and 13 people work on extracting the oil. The environmentally friendly project has been supported by the Ministry of Agrarian Development (MDA) and the German Embassy, among others. The main hindrances to the production of cosmetics are the achievement of high-quality products and the lack of an efficient selling strategy.32 In Buriti, the women’s group has the charismatic leadership of Dona Eterna, who is the head of both organizations, the Farmacinha and the Association of the Ipês. Dona Eterna is the only healer and authority on health in the group. With no formal scholarly education, she is one of four herbalists in the city, but is said to be the only one with the gift (‘o dom’). The gift is expressed in the innate skill of healing, in the intuitive ability to recognize the medicinal properties of plants and in making the right diagnosis: ‘Many know the plants but haven’t got the gift’ (Interviewee E, August 2011); ‘It is God’s gift. It is in the blood’ (Interviewee B, August 2011). The gift is the virtue of healers. Healers are opposed to the opportunism of some herbal traders: ‘They remove all plants and take them all to sell. They can’t do that!’ (Group Interview, Buriti, August 2011). Healers might also trade with herbs to assure their livelihood. However, traders are easily inclined towards free-riding, for example, demanding high prices and overexploiting natural resources and, as a result, they are often seen by Pacari’s health practitioners as ‘quacks’ (Lobato de Oliveira 2008: 42).

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Those who aim primarily at maximizing their material advantages act against the ethos of health assistance. The ethos of health assistance, an essential feature of Pacari’s healers, is the sense of duty in benefiting the person in need and rejecting the commodification of health: ‘What I want is to assist the people’ (Interviewee B, August 2011); ‘If the person is not able to pay we donate’ (Interviewee D, August 2011). This ethos makes exclusive property rights on therapeutic indications based on commonly shared TMK unacceptable: ‘These exclusive rights are unfair!’(Interviewee B, August 2011). The community of Cedro Historically, the Cedro community arose in the nineteenth century from the liberated slave Chico Moleque, who was able to buy an extended piece of land for farming (Ioris and Moraes 1999: 14). Today it has 78 black families and is in the legal process of becoming a Quilombo, that is, according to Decree no. 4.887/2003, a legally protected area based on the ancestral rights of fugitive slaves, enabling the dwellers to recover historically used lands in the form of a collective and with an inalienable title. In Cedro, a large part of the lands were sold as a result of the impoverishment of the community, especially because of the transformation from human labour to mechanization in the regional economy during the 1970s (Ioris and Moraes 1999: 15). The Cedro community is located in the city of Mineiros, about 420 km from the capital of the State, Goiânia. Today Cedro has a set of projects for income, environmental sustainability and community integration, mobilizing efforts to overcome poverty and alleviate the strong exodus of young people, who leave the rural area to study and work (Ioris and Moraes 1999: 15). The local pharmacy was set up in 1997/1998, at a time when the Cedro community was starting a process of political and cultural selfdetermination and taking its first steps towards the establishment of a residents’ association and achievement of the legal status of a Quilombo (Interviewee A, August 2011). This process was made possible by a favourable set of conditions, such as grassroots meetings in the region, supporting organizations and the leadership of key people,33 especially of Lucely Morais, a black woman descendant from Chico Moleque and one of Pacari’s founders. TM practices have a strong tradition in the community of Cedro. According to interviews, the majority of community members are acquainted with the use of medicinal plants, even though only a few having the gift are considered to be the local authorities on health. In the past, the community used TM mainly for its own members. Not many of the older raizeiros remain. Speaking of the past, they would not give their knowledge away because self-medication is dangerous and strangers could take

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Figure 4.4 Cedro’s community leaders and labelled sugar cane juice candy, Mineiros, Goiás, Brazil, Aug 2011 (photograph by John B Kleba)

advantage of it by buying the cheap medicines and reselling them with high profits (Interviewees F and G, August 2012). The TM patterns of the older generation changed dramatically with the development of the community pharmacy, the formal education of community members and Pacari’s working concepts. With the support of local organizations, the community was able to set up a modern building for the pharmacy, 34 comprising a set of functional rooms and equipment, including a kiln used for drying and sterilization, a water distiller and a dark storage room. The building is close to a community meeting area with a library and a computer room, representing the achievement of spaces of local empowerment. In the pharmacy, three people are employed as permanent staff, earning a small income from the surplus from sales. The staff occasionally have the help of other community members – the mutirão, for example, when the medicinal garden needs weeding. As in the case of Buriti, medicines are exchanged for products, either given or sold. But here a community member is distinguished from an outsider. The former exchanges, while the latter is expected to pay. Cedro’s community has had many problems to tackle. For example, under its last administration, the pharmacy had problems of bad management resulting in the loss of resources secured

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by project funding (Interviewee H, August 2011). The new administration, however, is regarded as very efficient. Pacari’s concepts were applied in the community of Cedro on many fronts. The people of Cedro formed a partnership with seven landowners with legal reserves for sustainable plant extractivism. Cooperation was established with the municipal faculties, offering scholarships to community members, for example, on pharmacology and agronomy, in exchange for workshops on environmental management for students in the area of Cedro, one of these having about 200 participants (Interviewee A, August 2011). Furthermore, a partnership with the Children’s Pastoral and the National Health System (SUS) is in place, through which some TMs are used by 87 health agents, each assisting an average of 150 families (Interviewee A, August 2011). In short, the community aims for empowerment and the valuing of TK depend on a set of favourable internal and external conditions, such as leadership, good management, material resources, capacity building and partnerships with public and private organizations.35

Figure 4.5 Cedro’s community pharmacy, Mineiros, Goiás, Brazil, Aug 2011 (photograph by John B Kleba)

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Discussion issues Reinventing to preserve There has been a resurgence in TM practices in the Cerrado as a result of their reinvention to cope with social changes. Traditionally, TM learning has had two main sources: the family (Articulação Pacari 2009: 82) and a wide information exchange network between interested users and health practitioners (Interviewee B, Aug 2011). Today these patterns are overlapped by social changes influenced by formal education and health professionals and organizations. Considering that the illiteracy rate amongst the older generation of raizeiros is about 50 per cent (Articulação Pacari 2009: 81), it is evident that the changes taking place are having a remarkable effect on the life of the communities. In the community pharmacies, medicinal preparations have become standardized, recipes have been turned into written records, and modern methods for measuring and stabilizing preparations have been introduced. This reinvention is a sociological hybrid of traditional and posttraditional lifestyles (Giddens 1997) in a process of adjustments with overlapping and contradictory features.36 For instance, one of the interviewees pointed out that her local community would not disclose dozens of medicinal plants because of the lack of studies about their safety and efficacy, and she did not even use them in pharmacy recipes (Interviewee A, August 2011). This attitude is antagonistic towards the traditional sharing of knowledge about individual plant properties, and the checking of their efficacy and safety by a large community of users over long time periods as well as by self-experimentation. Countless case stories told about healing makes this continuous feedback spiral visible (Interviewee B, August 2011). Although the boundary between traditional and post-traditional is becoming blurred, for Pacari this distinction not only remains but is of major political relevance in light of the large number of non-local species introduced in the TM of the Cerrado in recent decades. Recalling a sampling of 31 community pharmacies mentioned above, from the 70 species used per pharmacy only 40 per cent were native to the Cerrado (Articulação Pacari 2009: 44). Pacari is strongly engaged in reversing this situation. Moreover, the traditional system of teaching TK within the family through generations and based on oral learning is deteriorating as a result of social changes, which value formal education and dismiss the wisdom of the elders. In this sense, the making of the Pharmacopoeia helps bridge the experiences of the old with the rationality of the new times by bringing together research and the revaluation of TM in a process of exchange and learning on a large scale.

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But do the new practices of TM in the Cerrado still fit into the legal concept of protected traditional knowledge? I will argue that they do, as the renewed TM is consistent with its heritage’s foundations and with its particular health ethos. Moreover, this remaking of tradition is built in opposition to the modernity of the biomedical paradigm. TM practices integrate and adapt only modern concepts which are compatible with their own traditional core beliefs, like good health practices, quality control and environmental management, and oppose incompatible features like the commodification of health, the isolation of active ingredients, detachment from space and culture, and a high level of bureaucratic control. In conclusion, in its reinvention the TM of the Cerrado has been capable of simultaneously learning modern concepts of health and retrieving its distinctive features. The self-reproduction of TM TM can be better comprehended as a set of cultural and natural goods involving knowledge, plants, health access, etc. In considering how TM knowledge flows and what threatens its self-reproduction, I will focus on four dimensions: interactions inside the ILCs, the stock of plants, links with the industry and links with the public health system. The TM of the Cerrado is the common property of its health practitioners. This common property is grounded in customs, has achieved protection by ABS laws and was politically claimed by Pacari. Ostrom (2000) has shown that self-regulation of ILCs organized in the form of common property regimes is able to provide highly efficient resource management. What maintains the self-reproduction of the TM of the Cerrado is a set of social institutions, mainly of an informal nature, such as the ethos of health assistance and the complex scheme which allows everyone access to health by combining practices of exchanging, giving and paying. Sharing knowledge on TM is itself an institution, producing social integration and benefits. Inside the communities, knowledge of the properties of medicinal plants is largely shared among patients and healers. Between communities, the patterns of sharing are similar, although for different reasons, such as the common political interest. Political networking is perceived by community leaders as a tool of empowerment for the survival of TM practices. Nevertheless, the result of widely shared knowledge is not standardizing TM practices. Pacari has supported the self-reliance of ILCs by emphasizing the local roots of knowledge and of environmental interdependence. This localism explains the high variability of recipes for the same illnesses and the freedom for health practitioners to experiment and adapt.37 TM relies on the provision of a continuous stock of shared medicinal plants. In their in situ condition, medicinal plants are units of a common pool resource vulnerable to subtraction (Hess and Ostrom 2003: 119–120).

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Overexploitation and the unbalanced expansion of ranching and agriculture make it difficult, if not impossible, for herbalists to access the resources. Rare endemic plants may become extinct. Even with an environmentally friendly new Forest Code, there is great scepticism about its enforcement in such a large country with countless properties. The ILCs of the Cerrado have established strategies to tackle these problems by encouraging environmental protection in their neighbourhoods and disseminating sustainable extractive techniques. The extent of such efforts is, however, limited and cannot compensate for the lack of more effective environmental policies. A further concern is about the flow of TK out of the ILCs’ social networks towards commodification. Here the common pool of plants becomes intangible genetic and biochemical information. Having their therapeutic indications and useful plants as disseminated knowledge, the ILCs are unable to exclude the opportunistic use of this stock for product development of phytomedicines and drugs. Efforts by Pacari in this sense have shown to be of no avail.38 Furthermore, TM that for ILCs is nonalienable, is transformed in this process into an alienable asset linked to exclusive intellectual property rights. Considering that at least 25 per cent of all modern medicines and, for example, 60 per cent of antitumour and antimicrobial drugs are based on medicinal plants primarily related to TM knowledge (Robinson and Zhang 2011: 4, 10), free-riding over ABS rights is evident. In Brazil, for example, from a sample of 55 Brazilian native species used as primary ingredients in registered phytomedicines until March 2008 (Carvalho 2011: 69), not a single benefit-sharing contract has been negotiated with ILCs.39 Does the public health system represent a favourable institutional setting to foster TM practices? In giving priority to access to health, it has an ethos similar to the ILCs. However, operating in the realm of the public domain, the national health system is inclined to incorporate the common property domain as its own, ignoring the particular rights of ILCs. The public health system uses TM knowledge but dismisses the participation of its practitioners. Failing to integrate TM practices in public health properly, governmental policies are threatening the continuity of such practices. New uses of TM and the case of Fitoscar For pharmaceutical products developed through access to TM knowledge in compliance with ABS laws, two main legal questions need to be clarified: extension of the protection of widely disseminated TK (Kleba 2009) and temporal scope (IISD 2010: 4). Commenting on the Protocol, Kamau, Fedder and Winter (2010: 255) argue that ‘drawing on the Vienna Convention on the Law of International Treaties there is no such general obligation’ (of legal retroactivity), but the courts could interpret

72 John Bernhard Kleba ‘that new uses of genetic resources accessed before legal obligations are a new act’. Buck and Hamilton come to a similar conclusion (2011: 57). The case of Fitoscar is a remarkable example in this respect. Fitoscar is an ointment, based on Barbatimão’s extract for healing decubitus ulcers, recently launched by a partnership between the Brazilian company Apsen Farmacêutica S/A and the University of Ribeirão Preto (UNAERP). Barbatimão (Stryphnodendron barbatiman mart. or S. adstringens) is, due to its high relevance to the TM knowledge of the Cerrado, one of nine plants selected by Pacari for an in-depth study in the Pharmacopoeia. According to Marques (2011), UNAERP has done research on this plant since 1992. The Brazilian authoritative body Genetic Heritage Management Council (CGEN)40 states that it requires authorization for new uses of genetic resources.41 As a result, in 2005 UNAERP applied for authorization from CGEN to access genetic resources and in 2006 the authorization was issued.42 The researchers obviously knew that the plant is used in the Cerrado’s TM for healing decubitus ulcers, among other uses (Marques 2011). CGEN has, however, interpreted this access as not related to TK. Additionally, the proposed benefit-sharing contract, stating a non-monetary benefit to a private landowner and designed for the commercial supply of the plant, was accepted by the regulatory body. As we see below, this case indicates a serious failure of regulatory adjudication. Bearing in mind that the Brazilian ABS legislation MP 2.186-16 came into force in 2001 (the first version was published in June 2000),43 let us check the evidence for this new use. According to the National Intellectual Property Institute (INPI) the patent was filed on 11 November 2003 but the process was archived in May 2007.44 The ANVISA register was first published on 14 July 2008.45 The scientific core publication by UNAERP is dated 2010.46 As a result, there is a new use made by Fitoscar’s commercial ointment, which might be determined by the date of its invention, disclosure or patent filing. However, there is no plausible justification for why the new use applies to genetic resources but not to TK. Both were known before the enactment of ABS laws and in the case of Barbatimão, the new use of one implies the new use of the other, regardless of how disseminated they were known to be. This exclusion has not only resulted in depriving the ILCs of the Cerrado from their rights, but has also raised insecurity about how ABS laws are being interpreted and enforced. The current picture is that of a one-way train carrying away the TM knowledge of the people who are facilitating the development of modern medicines in the first place. The word train (trem) is used in the Cerrado as slang for thing. But how shall this train – the flow of TM knowledge – return to benefit the ILCs?

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Conclusion – Making the train return to benefit local communities The study provides evidence that deficiencies in policy and law in the areas of health, environmental protection and ABS are threatening the selfreproduction of TM practices, diminishing the rights of ILCs and failing to produce incentives for biodiversity protection (see Annex 1, 21, 26 NP). The ABS regime particularly has been regarded as highly deficient in meeting fairness and efficiency (Winter 2009; De Jonge 2009). In this regard initiatives such as Pacari could contribute to remedy the shortcomings of the ABS regime. First, potential conflicts between ILCs over the legitimate rights over TK are reduced when this knowledge is stated as common property of a large collective actor. Further, a benefitsharing contract with Pacari would, rather than driving the benefits to a single private landowner, steer them towards a collective body, resulting in the improvement of the livelihoods of people in need and effectively creating incentives for valuing TM knowledge and protecting the environment. Pacari has decided in favour of making the TK public in the Pharmacopoeia of the Cerrado as a strategy of defensive protection. The publication of the 264 medicinal plants in the Pharmacopoeia is a first step towards a ‘community protocol’ according to Article 9 of the Nagoya Protocol (Interviewee C, April 2012) and paves the way for the identification of legitimate stewards of TK and its representative body. Registers of TK facilitate the checking of patents filings and registered medicines. However, in order to be able to check which plants are claimed as traditional heritage, there must be an enormous effort in taxonomic clarification. Different plants can have the same popular name and even scientific names may lack clarity, as is well exemplified by the case of Barbatimão (Occhioni 1990: 153; Fonseca and Librandi 2008). The implementation of the Protocol can easily be watered down due to the limited capacity of state agencies to track down the commercial uses of medicinal plants. More effective policies should be put in place. For example, the Brazilian government is considering the establishment of a general tax on biotechnological products, from which revenues will flow to participative managed funds for conservation and TK.47 Combining measures of compliance with flexibility, Brazil has progressed in making access authorization for the granting of patents resulting from national genetic resources obligatory, enabling the same to be provided at the later stage of patent examination.48 Empirical data show that TK rights go beyond rights of consent and benefit sharing. In the case of Pacari, this means effectively supporting TM in law and policy. It means a different kind of relationship with the environment and the enclosure of lands, encouraging the creation of reserves and rights to access land. It means reinventing TM knowledge as a bottom up educational process, including good health practices and

74 John Bernhard Kleba sustainable extractivism. The TM of raizeiros and raizeiras of the Cerrado is a collective domain to which the ILCs are and will remain the guardians and beneficiaries.

Notes 1

This chapter is part of the project ‘Common pools of genetic resources’ financed by DFG, Germany, and coordinated by Professor Gerd Winter, FEU/ University of Bremen. Special thanks to Dona Eterna, Lucely Morais, Ivan Pio, Lourdinha and Jaqueline E. for making the empirical research not only possible but also very enjoyable. Many thanks to Evanson Chege Kamau, Martin Pohlit and Gerd Winter for comments and suggestions. 2 The medicinal knowledge of Pacari’s communities published by the Articulação Pacari (2009) has been considered by the Brazilian regulatory body as traditional in the sense of the MP 2186-2001. 3 The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the Convention on Biological Diversity was established by the 10th Conference of the Parties of the CBD on 29 October 2010, in Nagoya, Japan. It comes into force 90 days after the deposit of the fiftieth instrument of ratification. On 16 January 2013 it had 92 signatories and 12 ratifications (http://www.cbd.int/abs/nagoyaprotocol/signatories, viewed 26 February 2012). 4 In a sample of 13 major countries, Vivas-Eugui (2012: 10) found only 20 approved ABS contracts with commercial purposes, 15 of them from Costa Rica, in which INBIO’s policy had no TK communities as parties. 5 A Pharmacopoeia (US: Pharmacopeia) is ‘a work containing monographs of therapeutic agents, standards for their strength and purity, and their formulations’ and Pacari uses the term ‘Popular Pharmacopoeia’ intentionally to establish an equivalence of value between scientific and traditional medicine, http://www.medilexicon.com/medicaldictionary.php?t=67745, viewed December 2011. 6 The main part of the empirical research was undertaken in August 2011 with a two-day visit to each community, which included individual and group interviews and visits to reserves of extractivism, pharmacies, installations, medicinal gardens and community projects. Both cases were selected for being examples of good practice. Complementary data were obtained from Pacari’s leaders Lourdes Laureano and Lucely Morais, from documents and by email and telephone communication with key persons. 7 Pacari became a non-profit civil association in 2005. Its head office is now in the capital Brasília. Policy coordination is conducted by a board comprising four community representatives and a technical advisory group consisting of an agronomist, an ethnobotanist, a pharmacist and a biologist (Ata da Assembléia Geral de Constituição da Articulação Pacari, p. 9. Associação Pacari. Estatuto Social). 8 The states are Goiás, Maranhão, Minas Gerais and Tocantins. 9 Term used in Latin America for harvesting and collecting plants and parts of plant. 10 For a broader definition of TM, see WHO 2002: 7. 11 Lourdes Laureano, personal communication, April 2012. For more details, see Articulação Pacari 2009. 12 Farmácias-Vivas was created in 1985 by the Professor of Pharmacology Francisco José de Abreu Matos at the Federal University of Ceará.

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13 The original list of 582 plant names was shortened by aggregating different popular names to the individual plants (Articulação Pacari 2009: 86). 14 In 2006 there was a failed attempt to register the book as such because it fell outside the legal scope of the Resolution 001/06/IPHAN regulating intangible heritage. In 2009 a new application was made, with the Pharmacopoeia as additional proof. Registration requires a study with documentary proof carried out by the non-governmental organization Casa Verde. (LUZ, Luciana B. (National Institute for the Historical and Artistic Heritage – IPHAN)), personal communication, 29 February 2012. 15 The first has its own building with regular opening times; the second is located in the kitchen of a private person who provides health services in a more informal way (Articulação Pacari 2009: 44). 16 As a concept for making health accessible to the poor, the Catholic Health Care Pastoral had its origin in São Paulo in the 1970s. In 1986 it was established nationwide by the CNBB – Conference of the Bishops of Brazil – and included Pastoral Care for Children, http://pastoraldasaudesp.org.br/hist_origem. html, viewed 22 October 2011. 17 The procedure includes a workshop organized by Pacari’s professionals, usually financed by the municipal Health Secretary or by Pacari’s own funding, and is supported by voluntary work. 18 http://farmaciavivaceara.blogspot.co.uk/2010/08/entrevista-professor-abreumatos.html, viewed 22 October 2011. 19 http://mpopularv11.blogspot.com, viewed 22 October 2011. 20 Civil society organizations have repeatedly complained of the lack of participation in the development of Brazilian health policy. See e.g.: www. anvisa.gov.br/medicamentos/fitoterapicos/mesa_redonda_cop8.pdf, viewed 21 November 2011. 21 Among others, the cases of thalidomide and of John Lykoudis and the peptic ulcer can be quoted, besides systematic medical errors in current health systems. As examples see: Linda Bren (2001) ‘Frances Oldham Kelsey: FDA medical reviewer leaves her mark on history’, FDA Consumer Magazine, Mar–Apr, 24–29; Weiss, ES (2010) ‘Reflux, revolution, and the role of forgotten research in medical paradigms’, Department of History of Medicine, UWOMJ, Fall 2010 (79:2): 16–18; Rothschild, J. et al. (2005) ‘The critical care safety study: the incidence and nature of adverse events and serious medical errors in intensive care’, in Critical Care Medicine, 33 (8): 1694–1700. 22 Lourdes Laureano, personal communication, April 2012. 23 In order to protect the privacy of the interviewees, names and places have been withheld and a code (from A to G) is used for in-text citations. 24 This is part of the Program of Family Health (PSF). (Brazil, Health Ministry, ht t p://p or t a l. s aude.gov.br/p or t a l/s aude/G e stor/v i su a l i z a r_ t exto. cfm?idtxt=35352, viewed 14 October 2011.) 25 This list has been updated to 89 species, of which 54 per cent have geographical distribution in Brazil and 40 per cent are registered by ANVISA (Carvalho 2011: 200). 26 Both are designed for traditional peoples aiming to protect their livelihoods by means of sustainable uses of natural resources. The dwellers get a contract of use rights whereas the area remains state property, http://www.icmbio.gov. br, viewed 10 August 2011. 27 The first municipal law was passed in 2003 and the concept was spread to other municipalities and neighbouring states (Cornwall et al. 2008: 18–19). 28 The Brazilian Forest Code was established in 1965 by law 4.771.

76 John Bernhard Kleba 29 A revised law was recently passed in the Senate and the lower house of Congress accompanied by a heated public debate between the agribusiness lobby and environmentalists. 30 Data for 2010: http://www.ibge.gov.br/cidadesat/link.php?codmun=520393, viewed 19 August 2011. 31 These entrepreneurial initiatives are supported by the Ministry of Agrarian Development, Secretary of Family Agriculture. 32 Lourdes Laureano, personal communication, April 2012. 33 A decisive role has been played by e.g. the aid of the bishop Eric J Deitchman. 34 Support came from the environmental EMAS Foundation and the local University UNIFIMES (Interviewee A, August 2011). 35 Among others, the community benefits from the Emas-Taquari Biodiversity Corridor Project of Conservation International in partnership with the NGO Oreades and the firm Bunge (http://www.oreades.org.br/carbono/?menu= viveiros, viewed 16 January 2013). 36 In which social rituals – such as the mutirões – and reflexivity compound new ways of life. 37 For example, recipes for the treatment of colds in a sample made in three different local pharmacies of Goiás show respectively seven different and two similar plants, three different and two similar plants, and four different plants. (Direct observation.) 38 According to the interviews, attempts to control visits to community pharmacies and to withhold recipes have continually failed. 39 From 2002 to 2010 CGEN authorized only two applications to access TK associated with genetic resources that had potential commercial purposes. (Ministry of Environment Report, Genetic Heritage Department (MMA/SBF/ DPG), Relatório de atividades, 2010.) 40 CGEN was created by MP 2186-16, 2001 and Decree no. 3.945, 2001 as a decision-making and standard-setting agency for ABS issues and is located within the Ministry of Environment. 41 Genetic Heritage Management Council, personal communication, 12 January 2012. 42 Ministry of Environment, Deliberação no.§ 163, 28 September 2006, Diário Oficial da União, 17 October 2006. 43 MP 2052/2000. 44 Patent file number PI0305535-3 A2 (INPI online database, http://www.inpi. gov.br, viewed 19 August 2011). 45 See http://www7.anvisa.gov.br/datavisa/consulta_produto/rconsulta_produto_ detalhe.asp, viewed 19 August 2011. 46 Isler, AC, Lopes, GC, Cardoso, MLC, Mello, JCP and Marques, LC (2010) ‘Development and validation of a LC-method for the determination of phenols in a pharmaceutical formulation containing extracts from Stryphnodendron adstringens’, Química Nova, 33 (5), 1126–1129. 47 The news release date is 2012. The same idea was proposed in a draft bill law of 2007, http://oglobo.globo.com/economia/brasil-quer-taxar-riqueza-genetica3731701#ixzz1kIfNtIZI, viewed 23 January 2012. 48 The procedures are stated in Resolutions 207/2009/INPI and 208/2009/INPI, published on 30 April 2009.

References Articulação Pacari (2009) Farmacopéia popular do Cerrado, (Evangelista, J and Laureano, LC (eds)), Goiás.

Pooling TK/GR: the case of Pacari 77 Baer, HA (2004) ‘Medical pluralism’, in Ember, CR and Ember, M (eds), Encyclopedia of medical anthropology – health and illness in the world’s cultures, Kluwer Academic/Plenum Publishers, New York, pp. 109–116. Buck, M and Hamilton, C (2011) ‘The Nagoya Protocol on access to genetic resources and the fair and equitable sharing of benefits arising from their utilization to the Convention on biological diversity’, Review of European Community and International Environmental Law (RECIEL), 20, (1), 47–61. Carvalho, ACB (2011) ‘Plantas medicinais e fitoterápicos: regulamentação sanitária e proposta de modelo de monografia para espécies vegetais oficializadas no Brasil’, PhD thesis, University of Brasília, Brasilia. CI (Conservation International) (2011) Cerrado, http://www.biodiversityhotspots. org/xp/hotspots/cerrado/Pages/default.aspx, viewed 10 July 2011. Cornwall, A, Romano, J and Shankland, A (2008) ‘Brazilian experiences of participation and citizenship: a critical look’, Discussion paper 389, Institute of Development Studies, Brighton. de Jonge, B (2009) ‘Plants, genes and justice’, PhD thesis, Wageningen University, Wageningen. Dutfield, G (2006) ‘Protecting traditional knowledge: pathways to the future’, Issue paper 16, ICTSD, Geneva. Dutfield, G (2011) ‘A critical analysis of the debate on traditional knowledge, drug discovery and patent-based biopiracy’, European Intellectual Property Review, 33 (4), 238–244. Evangelista, J and Laureano, LC (2007) ‘Medicina popular e biodiversidade no Cerrado’, LEISA, 4 (4). Fonseca, P and Librandi, APL (2008) ‘Avaliação das características físico-químicas e fitoquímicas de diferentes tinturas de barbatimão (Stryphnodendron barbatiman)’, Revista brasileira de ciências farmacêuticas, 44 (2), 271–277. Giddens, A (1997) ‘A vida numa sociedade pós-tradicional’, in Giddens, A, Beck, U and Lash, S (eds), Modernização reflexiva – política, tradição e estética na ordem social moderna, UNESP, São Paulo, pp. 11–24. Hess, C and Ostrom, E (2003) ‘Ideas, artifacts, and facilities: information as a common-pool resource’, Law and contemporary problems, 66 (1 and 2), 111–145. ICMBio (2011) Cerrado, http://www.icmbio.gov.br/portal/biodiversidade/unidadesde-conservacao/biomas-brasileiros/cerrado.html, viewed 10 July 2011. IISD (International Institute for Sustainable Development) (2010) ‘Summary of the tenth conference of the parties to the Convention on biological diversity: 18–29 October 2010’, Earth Negotiations Bulletin, 9 (544), http://www.iisd.ca/ download/pdf/enb09544e.pdf, viewed 10 January 2013. Ioris, EM and Moraes, L (1999) ‘Projeto plantas medicinais – Comunidade do Cedro’, in Ioris, EM (ed.), Plantas medicinais do Cerrado: perspectivas comunitárias para a saúde, meio ambiente e o desenvolvimento sustentável, Anais do Workshop Plantas Medicinais do Cerrado, FIMES, Mineiros, pp 13–28. Kamau, EC, Fedder, B and Winter, G (2010) ‘The Nagoya Protocol on access to genetic resources and benefit sharing: what is new and what are the implications for provider and user countries and the scientific community?’ Law, Environment and Development Journal, 6 (3), http://www.lead-journal.org/ content/10246.pdf, viewed 10 January 2013. Kleba, JB (2009) ‘A socio-legal inquiry into the protection of disseminated traditional knowledge – learning from Brazilian cases’, in Kamau, EC and

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Winter, G (eds), Genetic resources, traditional knowledge and the law. Solutions for access and benefit sharing, Earthscan, London, pp. 119–142. Laird, SA and Wynberg, R (2005) ‘The commercial use of biodiversity: an update on current trends in demand for access to genetic resources and benefitsharing, and industry perspectives on ABS policy and implementation’, Paper prepared for the fourth meeting of the Ad Hoc Open-ended Working Group on ABS (UNEP/CBD/WG-ABS/4/INF/5), 22 December. Lima, MG (2010) Mapa de fitofisionomias do Cerrado, MMA, Brasília. Lobato de Oliveira, E (2008) ‘Os saberes tradicionais de raizeiros e raizeiras na região central de Goiás: farmacinhas populares e políticas públicas de preservação do Conhecimento’, Undergraduate monograph, University of Brasília, Brasília. Marques, LC (2011) ‘Legislação de acesso à biodiversidade: relato de uma experiência positiva’, Presentation at the 5th Encontro Nacional de Inovação em Fármacos e Medicamentos, Fundação Faculdade de Medicina da USP, São Paulo, 29–31 August. Occhioni, EML (1990) ‘Considerações taxonômicas no gênero Stryphnodendron Mart. (Leguminosae-Mimosoideae) e distribuiçáo geográfica das espécies’, Acta Bot. Bras., 4 (2), 153–158. Ostrom, E (2000) ‘Private and common property rights’, in Bouckaert, B and Geest, G de (eds), Encyclopedia of law and economics, volume II. Civil law and economics, Edward Elgar, Cheltenham, pp. 332–379. Robinson, MM and Zhang, X (2011) The world medicines situation 2011: traditional medicines – global situation, issues and challenges, WHO/EMP/MIE/2011.2.3, WHO, Geneva. Sawyer, D (2002) ‘Plantas medicinais e fitoterápicos no Brasil’, Working paper series Textos Eco-Sociais, Issue no. 10-02, Instituto Sociedade, População e Natureza – ISPN, Brasília. Vivas-Eugui, D (2012) ‘Bridging the gap on intellectual property and genetic resources in WIPO’s intergovernmental committee (IGC)’, Issue paper no. 34, ICTSD, Geneva. Watson-Verran, H and Turnbull, D (1995) ‘Science and other indigenous knowledge systems’, in Jasanoff, S, Markle, G, Petersen, J and Pinch, T (eds), Handbook of science and technology studies, Sage, London, pp. 115–139. WHO (2002) Traditional Medicine Strategy 2002–2005, WHO, Geneva. Winter, G (2009) ‘Towards regional common pools of genetic resources – improving the effectiveness and justice of ABS’, in Kamau, EC and Winter, G (eds), Genetic resources, traditional knowledge and the law. Solutions for access and benefit sharing, Earthscan, London, pp. 19–36.

5

Guardians of the seed The role of Andean farmers in the caring and sharing of agrobiodiversity1 Mario Tapia and Brendan Tobin …of all the activities ever invented by humankind, agriculture is the most basic to its survival (Otto and Dorothy Solbrig 1994)

The trade in seed itself has been with us as long as agriculture itself (Pat Mooney 1983)

Introduction Seeds lie at the heart of humankind’s survival and development. Their economic, social and cultural value is immeasurable, and vast collections of genetic resources are now held by a host of ex situ facilities all around the world (Mooney 1983). The existence of such collections sometimes obscures the fact that the primary responsibility for maintaining crop genetic diversity, and with it global food security, still lies with farming communities, many of whom are poor and members of Indigenous peoples and ethnic minorities (Brush 1991: 155). In developing countries, local farmers’ varieties provide 60–90 per cent of seed planted, a figure that rises to 100 per cent if the formal plant-breeding sector is absent (Almekinders 2001: 5). Ex situ collections are dependent upon continuing access to wild and farmers’ varieties of seed to replenish their collections, making long-term conservation of agrobiodiversity dependent on in situ conservation of local varieties (Brush 1991: 154). Despite their importance, farmers’ varieties have, until relatively recently, been largely overlooked by agricultural science and they continue to face erosion in the face of insensitive agricultural extension programmes, perverse seed laws, intellectual property regimes and the impact of climate change. These threats are so severe that the need to conserve agrobiodiversity has become at least as crucial, if not more so, than the protection of wild biodiversity (Santilli 2012: xiv).

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Although considered a collective venture, conservation of crop diversity is mainly carried out by individuals with a personal passion for conservation of traditional varieties. Tapia (2008) estimates that in Peru there are between 260 and 320 community conservationists. These community conservationists or, as he likes to call them, ‘Guardians of the Seed’ typically maintain in excess of 60 native varieties of Andean crops (Tapia 2008). Referred to as Arariwa, in their own language Quechua, they traditionally work with little, if any, state or other support. For Virchow, the lack of such support reflects national and international failure to internalize the conservation costs of native varieties, which, he says, perpetuates ‘the threat of uncontrolled extinction of agrodiversity’ (Virchow 1999: 1158). Projects and programs for in situ conservation of agrobiodiversity, where they exist, tend to focus on what Vavilov has termed centres of crop diversity (Brush et al. 1981: 70). One of the best known centres of crop diversity is the Andean region where, in pre-Hispanic times, at least 160 species were cultivated for food, medicines, fabrics, housing and tools (Tapia and de la Torre 1998: 11). Amongst its genetic wealth, the Andes boasts the richest gene pool of potatoes in the world with over 2000 landraces, the product of more than 8,000 years of human intervention (Brush et al. 1981: 71). This chapter focuses on this most emblematic of Andean crops in order to examine a number of case studies of strategies adopted by Andean communities in Peru and Bolivia to protect, develop and share their agrobiodiversity. The first considers the role of local barter markets and seed fairs in securing community conservation and sharing of native potato seed in Peru. The second examines the collaboration of science and traditional knowledge in participatory plant breeding and the development of new markets for native varieties in Bolivia. The third focuses on the experience of a sophisticated community project, the Potato Park in Peru, and its impact on and use of community, national and international, mechanisms and institutions to protect agrobiodiversity and agricultural landscapes. This is followed by discussion of the interfaces between seed laws, plant breeders’ rights, farmers’ rights and in situ conservation of native varieties, with particular attention to efforts to establish agrobiodiversity zones in Peru. The study finds that long-term conservation of agrobiodiversity is vital for global food security and realization of human rights; is dependent upon the willingness of farming communities to continue in situ conservation of native varieties and their wild relatives; and cannot be guaranteed without a national and international commitment to internalize these conservation costs. It argues in favour of a more expansive approach to notions of farmers’ rights moving away from bilateral agreements and monetary compensation towards policies that support indigenous and local farming communities’ rights to their lands, resources, traditional knowledge and self-determination. It notes the

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threats posed to agrobiodiversity by perverse seed laws and plant breeders’ rights, and highlights positive legal measures for the protection of agrobiodiversity. It concludes that close collaboration with local communities and effective recognition and enforcement of their human rights and farmers’ rights, and in particular their own laws, traditions and resource management practices, will be vital for securing long-term conservation of agrobiodiversity and the equally vital protection and transfer of relevant traditional knowledge between generations.

Barter markets, seed fairs and gender equity in the Andes Access to seeds in the Andes is facilitated through a variety of traditional and modern ‘seed networks’. These include traditional exchange based upon systems of kinship, social relations and customary law; exchanges between diverse altitudinal fields; seed fairs and other competitive and incentive-based mechanisms; and a mixture of barter and commercial systems of exchange (Iriarte et al. 2000: 154). This case study examines the role of barter markets and seed fairs in securing access to native seeds and the development and maintenance of a common pool of native potato in Peru. Barter markets Barter (trueque), which may involve exchange of agricultural produce, natural resources, labour and other services, has for centuries, been at the heart of Andean social governance and subsistence strategies. In a seminal study of Andean farming communities, Mayer identifies five factors supporting the continuing use of barter systems in the Andes, where it: •

• • • •

facilitates trade/exchange based upon ‘specialization’ leading to a ‘double coincidence of wants’ (I have what he wants and he wants what I have); serves as a mechanism to overcome variations in harvest times, enabling access to desired foodstuffs prior to local harvest; acts as an alternative to the cash market network that extracts local produce for urban markets and returns manufactured goods; is a separate economic sphere maintained by the peasantry for their own benefit apart from the cash sphere; and facilitates exchange transactions in cash-poor societies (Mayer 2002: 157–158).

For Mayer barter is not commensurate with commercial exchange, as the lack of equivalencies between totally dissimilar products may result in exchanges that do not reflect the relative market price of each product (Mayer 2002: 144). Referring to a case where highland farmers exchanged

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their sheep at a greatly undervalued rate for valley peoples’ maize, he cites one highlander for the view that ‘they [valley people] too like to eat meat, and if we do not supply it to them this way they would not be able to obtain it’ (Mayer 2002: 155). Seen from this perspective barter takes on an aspect of protectionism or ‘favoured nation’ status that brings about greater stability in exchanges and provides some immunity from fluctuations in national and international markets (Mayer 2002: 155). Barter and rules of reciprocity are not of themselves a guarantee of equity and fairness, and may hide wider relations of inequality between parties to an exchange. However, where it is part of a system of repeated exchange with known people at particular times and places, it creates, in Mayer’s view, an ‘in-built tendency to act fairly, so that the opportunity to repeat the exchange is not spoiled’ (Mayer 2002: 144). Seen from this perspective, barter may, he says, serve as a ‘weapon of the weak’, promoting equality in transactions rather than equivalence in produce exchanged (Mayer 2002: 145). In the Andes women have been the power behind the development of so-called chalaypasa markets where communities from the Lares valley’s three agro-ecological zones – the yunga below 2,300 m.a.s.l., quechua from 2,300 to 3,500 m.a.s.l. and puna above 3,500 m.a.s.l. – come to exchange agricultural produce (Marti et al. 2010: 3–6). The first market was opened in the community of Lowaqay in the yunga zone in 1973, three markets opened in the quechua zone in 1982, and in 2003, a market was opened in the community of Wakawasi in the puna zone (Marti et al. 2010: 6). The largest and most influential market takes place every Monday in the town of Lares where yunga communities bring tropical fruits, communities from the highlands bring tubers including potato, oca, and olluca while communities in the middle valley bring maize to trade. They have been described as a local initiative which helps mitigate against failed agricultural policies that seek to pull small farmers into the cash economy, undermining their subsistence strategies and threatening crop diversity (Marti et al. 2010: 2). Mayer notes that the socalled green revolution left Andean farmers worse off than before, with profitability of potato agriculture falling between 1990 and 1995 (Mayer 2002: 210). The chalayplasa network of markets, which serve around 4,000 people from 31 communities are a local solution to the socioeconomic crisis faced by Andean communities enabling them, in the words of Marti et al., ‘to grow, trade and consume the foods that they wanted’ (Marti et al. 2010: 3). As such they may help to secure access by the poorest social groups to better food security and nutrition, promote conservation of native varieties and ecosystem services and enhance local control over production and consumption, while strengthening women’s control over key decisions affecting livelihoods and ecological processes (Marti et al. 2010: 3). Marti et al. identify three central aspects of chalayplasa:

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reciprocity based on friendship and kin relations between women from yunga, quechua and puna zones; redistribution based on social participation norms and access strategies to the different altitudinal tiers by different agro-ecological zone communities; and self-sufficiency based on subsistence farming by each household (Marti et al. 2010: 10).

The chalayplasa markets are a source of much greater crop diversity than commercial markets with approximately 86 per cent of listed crops from the quechua zone and 100 per cent of puna crops bartered in these markets, whereas only 34 and 60 per cent of produce from these zones makes its way into commercial markets (Marti et al. 2010: 8). With regard to potato varieties, up to 60 per cent of the region’s estimated 240 varieties are found in the chalayplasa markets, whereas a mere 23 per cent of native potato varieties meet the criteria for sale in more commercial markets (Marti et al. 2010: 8). This makes the chalayplasa markets an important source of seed for native varieties and veritable showcase for the wonders of agrobiodiversity. Seed fairs The use of the term ‘seed fairs’ to describe gatherings where Andean farmers display and exchange seed is of fairly recent origin. Beginning in Peru in the late 1980s, farmers were prompted to bring samples of their seed to fairs, which added an element of display of produce and competitiveness to traditional exchange of resources. Promoted chiefly by external parties including researchers, NGOs and the State, seed fairs have now become a regular part of the agricultural calendar in many parts of the Andes. The popularity and rapid uptake of seed fairs by local communities is linked to two principal factors. First, Andean communities have a long history of holding fairs where seed was exchanged and sold (CCTA 2001: 1). Second, in the 1980s, Peru suffered extreme flooding and droughts, which severely damaged community seed stocks. Seed fairs showed the resilience of traditional seed varieties and supported traditional distribution as communities and families sought to recover seed for varieties they had lost. The agricultural scientific community in Peru now sees seed fairs as a fundamental tool for conservation of agrobiodiversity ‘en chacra’ and to maximize the utility of native landrace diversity (Tapia et al. 1997: 179). Seed fairs are also seen as helping to reinforce farmers’ awareness of the importance of their seed collections, demonstrating the benefits associated with crop diversity and promoting production of good seed (CCTA 2001: 2). Furthermore, seed fairs play a key role in raising awareness of women’s central role in the selection and maintenance of

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seed, the importance of their participation in decision-making regarding agrobiodiversity conservation and in the sharing of benefits derived from its use. Seed fairs are now often included as part of larger conservation projects, such as the multi-year project in La Encañada, Cajamarca, where a revolving seed fund was established with farmers repaying loaned seed with seed from their own harvest, which in turn is made available to other farmers (Tapia 2008). In a study published in 2008, Scurrah et al. claim that seed fairs can have a negative impact where the promotion of competition between farmers makes them reluctant to share their new and best propagating material and even less willing to share their knowledge (Scurrah et al. 2008: 15–16). A further drawback of most existing seed fairs is their dependence on external parties and funding, which raises questions regarding their long-term durability. Despite their limitations, seed fairs continue to be popular among farmers, creating incentives for conservation and providing clear evidence of the richness of native crop diversity. While barter markets and seed fairs help to ensure continuing access to native seed varieties, something more is needed if native varieties are not to be forced off the land by high-yielding varieties and climate change.

Participatory plant breeding in Bolivia Potatoes are the most important crop for smallholder farmers in Bolivia with earnings from the sale of potatoes making up more than 60 per cent of the family income (Terrazas et al. 2005: 143). In 1998, more than 98 per cent of potato seed in Bolivia came from the informal system, either produced by farmers themselves, sourced through traditional kinship networks, or purchased from informal seed merchants (Bentley and Vasques 1998: 2). In 1989, the Bolivian National Institute for Agricultural Technology established the potato research programme Promoción e Investigación de Productos Andinos (PROINPA), to carry out research on the difficulties faced by smallholder farmers and develop participatory plant breeding strategies that empower campesino farmers to develop potato varieties capable of providing maximum yields under local conditions (Thiele et al. 1997: 276; IDRC 2003). With support from PROINPA, local community associations such as the Asociación de Productores de Tubérculos Andinos de Candelaria (APROTAC) have championed the development of new markets for their native varieties. This case study examines the role of PROINPA and APROTAC in participatory plant breeding, protection of native varieties, provision of clean seed with higher yields, and local innovation to capture national and international markets and secure conservation of native varieties.

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PROINPA and the role of science in in situ conservation In the late 1980s, PROINPA began to work with small farmers in Bolivia in a participatory plant breeding exercise facilitated by social scientists. Participation of local farmers included identification of their most important varieties, selection and marking of plants demonstrating the least amount of virus infection and collection of healthy tubers from each marked plant at harvest (Thiele et al. 1997: 157). In return, farmers received the cleaned seeds through their sindicato, which distributed seeds and informed farmers that these were their own seeds, cleaned and now returned (Iriarte et al. 2000: 155). From the outset, one of PROINPA’s primary activities has been the breeding and selection of varieties for resistance to late blight, which, in the 1980s, was estimated to be costing local farmers in excess of USD 6 million a year in lost revenue in the Cochabamba region alone (Thiele et al. 1997: 276). This led to a five-year programme (1990–1995) in which farmers and breeders in the region of Morochata and Chullchunquani in Cochabama participated in farm trials and selection of blight-resistant clones provided by the International Potato Center (CIP) and the Colombian Institute of Agricultural Research. The project demonstrated similarities in the selection criteria of farmers and breeders with both favouring high-yielding varieties free of disease and resistance to insect attack (Thiele et al. 1997: 287). Criteria diverged, however, in relation to market characteristics with farmers often selecting varieties that resembled the coloured skins and deeper eyes of Andean potato varieties, which, though less valued in commercial markets, may obtain a higher price than European varieties in local markets (Thiele et al. 1997: 284). Although the influence of farmers on the final selection of clones by breeders was in the foregoing instance slight, the project helped develop the capacity of breeders in PROINPA to participate more actively with farmers in germplasm evaluation (Thiele et al. 1997: 288). Farmers are now routinely involved in participatory evaluation of clones at PROINPA’s research stations and subsequently on their own lands (Weltzien et al. 2000: 28). By 2009, PROINPA’s gene bank boasted over 1750 accessions of primarily native varieties, of which between 150 and 200 are cleaned up each year; 15 native varieties had received state certification and at least 68 farmers had been registered to produce certified seeds of native varieties; and PROINPA’s Experimental Station at Toralapa was producing two to two-and-a- half tons of certified seeds of native varieties annually (Hidalgo et al. 2009: 42–44). Conservation and marketing of native varieties in Candelaria Release of pathogen-free certified seed has a major impact, with yields from cleaned-up landraces ranging from a 25 per cent increase to double

86 Mario Tapia and Brendan Tobin the previous yields prior to cleaning (Terrazas et al. 2005: 159). Increasing the capacity of farmers to take part in participatory breeding and to clean and certify seed is, therefore, key to securing increased yield and farmer empowerment. A positive example of farmer initiative and empowerment in Bolivia is the establishment by campesino communities of their own local committees for agricultural research (Comité de Investigación Agricola Local – CIAL). One of these, the CIAL Primera Candalaria, with the support of PROINPA, established APROTAC. Made up of 23 families from four communities in the Cochabamba region, APROTAC coordinates the activities of member families so as to enhance their collective capacity for production and marketing of both seed and fresh tubers into the Cochabamba markets (Hidalgo et al. 2009: 42). Increased market entry may have both positive and negative impacts on the conservation of native varieties. On the one hand, commercial interest in specific varieties increases the long-term viability of their conservation. On the other hand, concentration of production on commercial varieties may undermine communities’ traditional conservation priorities and fuel erosion of less commercially successful varieties. APROTAC, for example, commercializes only six native varieties or less than 10 per cent of the local diversity. For Terrazas et al., the real ‘challenge is to bring to market not only what the market demands but what the agroecosystem produces’ (Terrazas et al. 2005: 146). Similarly, Shepard, in a study of the role of cultural politics in Andean in situ conservation, warns that commercializing projects tend to place ‘a strong emphasis on improving the quality, uniformity, and yield per hectare of native varieties’ with the result that local farmers are in danger of becoming ‘technical assistants’ to agronomists who control and oversee their labour (Shepard 2010: 640). Small farmers promoting their native varieties in commercial markets may also face unfair competition; increased production by larger-scale farmers using improved varieties of coloured potatoes; disintegration of farmers’ organizations as individual farmers get capitalized and leave the association; overproduction leading to price falls; and, the threats to biodiversity conservation caused by concentration on commercial varieties (Thomann et al. 2009: 26). Furthermore, potato yields in Bolivia and Peru are well under the world average (17.6 t/ha) and very far behind countries like New Zealand (45.7 t/ha) or the Netherlands (43.2 t/ha) (Devaux et al. 2009: 31), making the capture of international markets very difficult. Securing fair and equitable benefit sharing arising out of large-scale and luxury markets in products developed utilizing native varieties will, therefore, require innovative mechanisms and attention to the capacity of existing international legal instruments to secure both farmers’ rights and the human rights of local and Indigenous communities.

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Community conservation: the case of the potato park The Potato Park is an initiative of six Peruvian Quechua communities supported by the Cusco-based NGO ANDES (Argumedo and Stanner 2008: 21). Located high in the Andes above the town of Pisac, in the Department of Cusco, the Park, which occupies over 10,000 hectares of community lands, was established in 1998 with the dual aim of conserving biodiversity and protecting local food security.2 Over time, its objectives have expanded to include community sustainable development through promotion of agro-tourism, development of small-scale community industries and maintenance of the region as an area free of genetically modified organisms. The Park adopts a three-pronged approach to the protection of agrodiversity. These are: the identification of community priorities and strengthening of local capacity and commitment to in situ conservation of potato varieties; the strengthening and development of participatory customary law-based governance systems for the regulation of the Park; and the utilization of national and international law, institutions and ex situ collections as a backstop for community conservation efforts (Tobin and Taylor 2009). This case study examines how the Park’s approach serves to (a) identify and establish the boundaries of a common pool of shared resources, (b) consolidate and secure the procedures for conservation of the pool and its governance structure, and (c) utilize external forces to protect and secure the long-term viability of the pool. A multifaceted approach to conservation of agrobiodiversity Starting with approximately six hundred of their own local varieties, the communities of the Park have progressively added varieties obtained from other sources3 so that by the end of 2011 they were managing in excess of 1500 varieties.4 Of these, more than 100 varieties were obtained from exchanges with communities outside the park, while hundreds more were obtained as a part of a series of agreements for repatriation of local varieties with the International Potato Center (CIP)5 (Argumedo et al. 2011; Argumedo and Pimbert 2006: 15). The collaboration between CIP and the communities of the Potato Park includes the installation of a system for the management of in-vitro plantlets ensuring that repatriation of potato varieties achieves the highest possible level of freedom from disease.6 In a partnership with CIP and the Global Crop Diversity Trust, Park communities will, between 2012 and 2014, send samples of all local native varieties to the Svalbard Global Seed Vault (SGSV) in the Arctic Circle (see Figure 5.2). This transfer, says Alejandro Argumedo, director of ANDES, will ‘guarantee the availability of our incredible potato diversity for future generations.’7

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Figure 5.1 Arariwa ‘community conservationists’ maintain the Potato Park gene bank in the community of Paru Paru, December 2011 (photograph by Brendan Tobin)

The six communities of the Park, represented by ANDES, have included their collection in the multilateral system established by the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA) through a notification letter to the Secretariat.8 Article 11.3 of the Treaty

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Figure 5.2 Arariwa ‘community conservationists’ of the Potato Park prepare samples of local potato varieties to send to Svalbard Global Crop Vault, Paru Paru, December 2011 (photograph by Brendan Tobin)

encourages natural and legal persons who hold plant genetic resources for food and agriculture listed in Annex 1, which includes potato, to include them within the multilateral system. By doing so, the Park communities have set an important precedent for farmer participation in the Treaty’s governance and implementation. Their action is in effect a declaration of the Park communities’ rights over their native varieties, many of which had already been included in Annex 1 by CIP and the Peruvian government. This includes rights to benefit sharing arising from their use. It also opens up increased possibilities for Park communities to directly access other genetic material, including, but not limited to, potato varieties within the multilateral system for their own ends. Customary law and Park governance The Park is governed by a collective management structure based on Andean traditional resource management practices promoting ecological, productive and social sustainability (Argumedo 2008: 47). These practices are reflected in principles and norms of customary law, such as reciprocity, duality, and equilibrium (Swiderska et al. 2006), which establish duties to nurture the earth in return for its bounty, avoid individualism inimical to

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collective welfare and seek balance and harmony in all aspects of life, including in interactions with the natural environment (Tobin and Taylor 2009: 44). Each community elects a so-called ‘barefoot technician’ responsible for representing their community in Park decision-making (Taylor 2008: 80). A key aspect of the Potato Park’s governance system is its foundation on the communities’ own laws and traditions, commonly referred to as their ‘customary laws’. The Park Council, for example, is guided in its day-to-day governance of the Park, by Quechua customary law principles, which are also at the heart of efforts to develop an intercommunity agreement to regulate issues such as Park governance and benefit sharing (Taylor 2008: 60). The agreements between CIP and the Park also draw on such customary law principles, and the Park Council seeks to build synergies with and strengthen the founding communities’ traditional governance systems (Tobin and Taylor 2009: 45). The Park’s customary law governance system finds support in both national and international law. At the National level, Article 89 of the Peruvian Constitution of 1993 recognizes the rights of Indigenous communities to autonomy in their organization, communal working and the use and disposal of their land. At the international level, Peru has ratified International Labour Organization Convention 169 on the Rights of Indigenous and Tribal Peoples in Independent Countries and is a signatory to the United Nations Declaration on the Rights of Indigenous Peoples. Both instruments recognize Indigenous people’s land and resource rights as well as their rights to be governed by their own customary laws (Tobin 2009: 103). The Potato Park provides a clear example of the importance of recognizing and respecting Indigenous farming communities’ rights to their own customary laws and selfdetermination as the basis for their conservation activities.

Farmers’ rights and agrobiodiversity conservation The notion of ‘farmers’ rights’, first promoted in the 1980s as a response to growing pressure for recognition of commercial plant breeders’ rights,9 has been adopted but not defined by the ITPGRFA. This section examines how seed laws and plant breeders’ rights threaten farmers’ rights and the measures taken by Andean countries to protect the region’s genetic resources and traditional knowledge. It also explores calls for expansion of the notion of farmers’ rights and closes with discussion of proposals for the establishment of agrobiodiversity zones for in situ conservation of native varieties and their wild relatives. Seed laws, intellectual property and prior informed consent National seed laws play an important role in securing seed quality. Traditionally, however, national seed laws have tended to restrict

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certification of seeds to what are termed ‘improved varieties’. As a result, the sale and sharing of uncertified seeds of native varieties, the primary source of seeds for poor Andean communities, has been made illegal. This was, in effect, the situation in both Peru and Bolivia until relatively recently. Thankfully, both countries have now begun to relax certification procedures to allow inclusion of cleaned native seed. In 2008, for example, during the International Year of the Potato, Peru adopted regulations enabling the certification of 61 native varieties with commercial potential.10 There are, however, up to 2,700 native varieties in Peru, and Andean farmers have called for modification of national seed laws to legalize the informal interchanges of native varieties between Andean farmers (Ruiz 2009: 93). Peruvian farmers, participating in a national consultation on farmers’ rights, have also called for simplification of procedures for the certification of commercial seed, which they argue should be free for native varieties, and a guarantee that procedures related to seed quality and phytosanitary standards do not conflict with the establishment of legal measures necessary for the conservation and sustainable use of plant genetic resources (Scurrah et al. 2008: 30). A second area of deep concern relates to the impact of plant breeders’ rights and patents on farmers’ rights to their own seed and to the seed from their harvest. Obligations under Article 27.3(b) of the World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) require all member states to provide sui generis plant variety protection. Before TRIPS even entered into force, Peru and the other member countries of the Andean community were placed under significant pressure to adopt the plant breeders’ regime established by the International Union for the Protection of New Plant Varieties (UPOV) (Tobin 1993). While succumbing to this pressure, the member countries through the Andean Community took counter-measures adopting Decision 39111, which establishes a regional regime on access to genetic resources and benefit sharing (ABS). Article 7 of the Decision requires states to respect the rights and authority of native, African–American and local communities over their knowledge, innovations and traditional practices associated with genetic resources. In 2000, the Andean Community adopted Decision 486, which requires that any application for a patent over products developed utilizing genetic resources or traditional knowledge from the region must show prior informed consent (PIC) for its use, including PIC of Indigenous, African–American and local communities, where appropriate.12 Obligations to secure PIC of Indigenous and local communities for access to and use of their resources and knowledge have been further strengthened by the adoption of the Nagoya Protocol to the Convention on Biological Diversity in October 2010. The Protocol requires states to take measures to ensure that access to the genetic resources and/or

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traditional knowledge of Indigenous and local communities is subject to their PIC.13 States are further obliged by Article 12 to take into consideration the customary laws and protocols of Indigenous and local communities in implementing the Protocol.14 The Protocol does not, however, apply to resources such as potatoes that fall within the scope of Annex 1 of the ITPGRFA, in so far as they are used for food and agriculture. The Treaty has, however, established its own multilateral benefit-sharing mechanism to secure equitable benefit sharing and has specifically recognized ‘farmers’ rights’ to share in benefits derived from the use of agrobiodiversity. Farmers’ rights Farmers’ rights to save, use, exchange and sell seeds lies, according to Santilli (2012: 211), at the heart of traditional resource management and the conservation and development of crop diversity. Under the ITPGRFA, responsibility for realizing farmers’ rights rests with national governments. Article 9 of the Treaty, under the heading farmers’ rights, requires states to take measures to protect and promote: 1 2 3

traditional knowledge relevant to plant genetic resources for food and agriculture (PGRFA); the right to equitably participate in the sharing of benefits arising from the use of PGRFA; and the right to participate in national decision-making on matters related to the conservation and sustainable use of PGRFA.

Farmers’ rights are seen by many as a means to defend ‘farmers’ customary rights to save, use and exchange seed benefit from their contribution to the global crop genetic pool and participate in decision making related to crop genetic resources’.15 A contrary view sees farmers’ rights as vesting ancestral entitlements to seed in the international community when what is required is ‘state action to curb the predatory practices of privatizers, the [plant breeders’ rights] and patent pushers’ (Kneen 2009: 75). In frustration at the failure of the international community to effectively secure farmers’ ancestral and human rights, attention is being increasingly drawn to Treaty Articles 5.1 on conservation and 6 on sustainable use of PGRFA. According to Argumedo et al., when taken together, these provisions require, a broad interpretation of farmers’ rights which goes beyond the right to benefit sharing, to include the right of farmers to continue the practices which contribute to the conservation and sustainable use of PGRFA, and to sustain the traditional knowledge and livelihood systems needed for this. Thus, in the context of the Treaty, protection of farmers’ rights requires protection of a broader set of rights than those identified in Article 9.2 (Argumedo et al. 2011: 2).

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Empowerment of farmers to regulate their ecosystems and their use of seed in accordance with traditional practices and their own customary laws may be seen, therefore, as one of the most important manifestations of farmers’ rights. Addressing this challenge is key to current efforts in Peru to develop agrobiodiversity conservation zones. Protected areas and agrobiodiversity zones Agrobiodiversity has traditionally fallen outside the traditional conservation community’s activities. According to a 2008 report, however, agrobiodiversity falls within the scope of what are termed ‘Category V protected areas’ (Amend et al. 2008), which IUCN defines as land with coasts and seas, as appropriate, where the interaction of people and nature over time has produced an area of distinct character with significant aesthetic, ecological and/or cultural value, and often with high biological diversity. Safeguarding the integrity of this traditional interaction is vital to the protection, maintenance and evolution of such areas (IUCN 1994). Based on analysis of nine case studies from around the globe, including one on the Potato Park, the report identifies four shared criteria vital for the successful conservation of agrobiodiversity. These are: • •

•

•

a social element: strong communities which value traditional land use systems but are capable of adapting to changed circumstances a governance element: systems of governance and land tenure that ensure that local people’s rights are protected, their customary laws respected and their views taken into account an economic element: a market for the products that come from systems of farming that rely on agrobiodiversity conservation, in which cost is not the only consideration a degree of wider support: from international bodies, governments and the general public, which values the communities who depend on traditional systems of agriculture with their associated agrobiodiversity. (Amend et al. 2008: 17).

In Peru, these criteria exist, at least in part, and work is well advanced in the development of a draft law for the establishment of agrobiodiversity zones. A first draft leaned towards the recognition of such zones as a form of protected area, falling outside the remit of the existing protected areas system (Ruiz 2009). Following further consultation with farmers and other groups, a revised draft moved away from a protected areas style protection in favour of, what Huamani describes as, an incentive based system.16 The draft regulation describes its general objective as being to offer ‘an option for human wellbeing, strengthening and consolidating the conservation, sustainable use and management of agrobiodiversity, by way of social recognition of campesino communities, native communities, farmers and

94 Mario Tapia and Brendan Tobin their associations’.17 It will, according to Huamani, promote increased protection of farmers’ interests through recognition of their land rights, and of their rights to restrict activities on their territories, while avoiding the imposition of the constraints associated with highly bureaucratic protected areas management.18 This approach accords more closely with campesino and native communities’ rights to govern their own affairs, lands and communal work practices in accordance with their own customary laws as set out in Article 89 of the Constitution19. A potential limitation of this approach, however, is the reduced level of protection it offers against the grant of mining or oil and gas exploration rights over lands recognized as agrobiodiversity zones. International support for protection of Andean agrobiodiversity zones has come from the Food and Agricultural Organization of the United Nations (FAO) programme on Globally Important Agricultural Heritage System (GIAHS), which has recognized the area around the famous Inca site of Machu Picchu as part of global agricultural patrimony. In 2010, the Peruvian Ministry for the Environment and FAO approved a major project to protect a variety of landscapes linked to Andean traditional agricultural life, including raised plots and terraced fields (Koohafkan and Altieri 2011: 21). The project counts on the support of the regional governments of Cusco and Puno, municipal governments of Lares, Lamay (Cusco), Azangaro, San Jose and Acora (Puno), as well as campesino communities along the so-called Cusco-Puno corridor.20 The project is designed to benefit upwards of 1,800 families from these communities. Four communities in areas that maintain the most traditional agricultural technologies have been selected as sites for specific activities. An important part of the project will be participatory production of high quality seeds of native crops and the strengthening of communal fairs and their role in facilitating the distribution of seed (Koohafkan and Altieri 2011: 21–23).

Conclusion The experiences of chalayplasa markets and seed fairs, of PROINPA and APROTAC, and of the Potato Park, demonstrate the central role that local communities play in in situ conservation of agrobiodiversity. They also show the diverse aims and objectives farmers have in conserving native varieties and the dangers for crop diversity posed by changes to traditional resource use and exchange systems. The chalayplasa markets and seeds fairs demonstrate opportunities for both communities and the research community to stimulate continuing intercommunity seed exchange. An inherent drawback of most existing seed fairs, however, is their dependence on external parties and funding, which raises questions regarding their long-term durability. Furthermore, while farmers enjoy seed fairs, their competitive nature may make farmers reluctant to share their new and best propagating material and knowledge.

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Participatory plant breeding programmes that focus on native varieties and empower local farmers to play a definitive role in the selection and development of crop varieties play an important role in the conservation of agrobiodiversity. Where, however, they lead to a focus only on commercial varieties for external markets, they may accelerate erosion of overall crop diversity. Although Andean countries are the centre of origin of the potato, their production capacity is far below the global average. It may, therefore, prove impossible for communities to capture a truly equitable share of the benefits derived from new mass and luxury markets based on their native varieties. This is especially true where native varieties are freely available through the ITPGRFA multilateral system. A focus on bilateral agreements and monetary compensation as a means to secure equity in benefit sharing and the protection of farmers’ rights appears doomed to fail. A more expansive approach will be required if the true costs of in situ conservation of agrobiodiversity are to be internalized and community conservationists equitably compensated. Above all, farmers’ access to seeds and their capacity to conserve and retain their own varieties and sustain their cultural links to their lands and resources must be secured. This will require a commitment to ensuring farming communities’ human rights, including their rights to their lands, resources and knowledge, and to govern their own affairs in accordance with their own laws and traditions. Making farmers’ rights a reality will require sensitive treatment of their native varieties in national seed laws and protection of their rights to use, share and exchange seed free of constraints by intellectual property laws. It will also require a real commitment to securing effective participation of farmers in defining priorities for agricultural research and in the development of relevant law, policy and agricultural extension programmes. The establishment of agrobiodiversity zones that confirm farmers’ land tenure and their right to regulate activities in accordance with their customary laws may prove a positive way to secure their rights. Such zones will only be meaningful, however, if they can provide a solid defence against natural resource exploitation by the mining, oil and forestry industries. To that end, obligations to secure prior informed consent of farmers, in accordance with their own laws and traditions for any activities on their territories, will need to be reflected in national laws and strenuously defended by national judicial and other authorities. Agrobiodiversity plays a vital role in securing food security, health and a host of other human rights including rights to autonomy and selfdetermination. At the same time, long-term in situ conservation of agrobiodiversity is dependent upon securing respect for Indigenous and local communities’ rights to their lands, resources, knowledge and selfdetermination. Securing these rights requires laws and policies that support Indigenous farmers’ notions of seed stewardship and recognizes and respects their customary laws and helps secure their spiritual, cultural

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and economic links to their lands. It will also be crucial to secure the full and informed participation of farming communities in the design of conservation and agricultural research programmes and to support the work of Arariwa community conservationists as the primary ‘guardians of the seed’. Only in this way can farmers’ rights be assured and farmers empowered to continue their millennial role as the foremost custodians of agrobiodiversity.

Notes 1 2 3 4 5

6 7

8

9 10 11 12 13

14

All URLs viewed 31 August 2011. See Potato Park website http://www.parquedelapapa.org Lino Mamani, Arariwa (community conservationist), personal communication, Potato Park, December 2011. Alejandro Argumedo, personal communication, Cusco, December 2011. The International Potato Center (CIP) is one of 15 research centres that make up the Consultative Group on International Agricultural Research (CGIAR), a strategic global alliance dedicated to ‘sustainable agricultural development and the preservation of our Earth’s precious resources and biodiversity’. See http://cipotato.org/about-cip Rene Gomez, curator of the collection of the International Potato Center, personal communication, Potato Park, December 2011. See ‘Peru: Peruvian potato farmers launch ambitious plan to send 1,500 varieties to Arctic seed vault’, Indigenous Peoples Issues and Resources, 18 February 2011, http://indigenouspeoplesissues.com/index.php?option=com_content& view=article&id=9008:peru-peruvian-potato-farmers-launch-ambitious-planto-send-1500-varieties-to-arctic-seed-vault&catid=23&Itemid=56 See notification letter sent to Shakeel Bhatti, secretary ITPGFA, by ANDES in representation of the potato park communities, dated 4 July 2008, http://www. planttreaty.org/sites/default/files/IT%20Application%20letter.Potato%20 Park.pdf For information on the Farmers’ Rights Project, see http://www.farmersrights. org/about/index.html Papas Nativas ya puedes ser inscritas en el Registro de Cultivares Comerciales de SENASA en Peru, AndiNota, No. 8, October 2008, http://www.infoandina. org/node/25702 Andean Community Decision 391, Common Regime on Access to Genetic Resources, 2 July 1996, http://www.comunidadandina.org/ingles/normativa/ D391e.htm Andean Community Decision 486 Common Intellectual Property Regime, 14 September 2000, http://www.comunidadandina.org/ingles/normativa/ D486e.htm See Articles 6, 7, Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the Convention on Biological Diversity: Text and Annex (Secretariat of the Convention on Biological Diversity 2011). For a discussion of customary law, the Nagoya Protocol and protection of Indigenous peoples’ rights over their genetic resources and traditional knowledge, see Tobin, B, ‘Why customary law matters: bridging the Nagoya compliance gap’, Law, Environment and Development (LEAD) Journal (forthcoming).

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15 See definition of farmers’ rights and materials on the Farmers’ Rights project, http://www.farmersrights.org/about/index.html 16 Walter Huamani, Ministry for the Environment, personal communication, Lima, December 2011. 17 See Article 7 Proyecto de Decreto Supremo para la Reconocimineto y Creacion de Zonas de Agrobiodiversidad [authors’ translation]. 18 Walter Huamani, Ministry for the Environment, personal communication, Lima, December 2011. 19 Constitution of Peru 1993, Article 89 Rural and Native Communities are legally recognized and enjoy legal status. They are autonomous in terms of their organization, communal working, use and free disposal of their land, as well as economically and administratively within the framework established by law. Ownership of their land is imprescriptible except in the case of abandonment described in the preceding article. The government respects the cultural identity of the Rural and Native Communities. 20 Sistemas Importantes del Patrimonio Agricola Mundial (SIPAM – Peru) Leaflet distributed by Ministry for the Environment, FAO and GEF.

References Almekinders, C (2001) Management of crop genetic diversity at community level, GTZ, Eschborn. Amend, T, Brown J, Kothari, A, Phillips, A and Stolton, S (eds) (2008) Protected landscapes and agrobiodiversity values: values of protected landscapes and seascapes, IUCN and GTZ, Heidelberg. Argumedo, A (2008) ‘The Potato Park, Peru: conserving agrobiodiversity in an Andean indigenous biocultural heritage area’, in Amend, T, Brown J, Kothari, A, Phillips, A and Stolton, S (eds), Protected landscapes and agrobiodiversity values: values of protected landscapes and seascapes, IUCN and GTZ, Heidelberg. Argumedo, A and Pimbert, M (2006) Protecting indigenous knowledge against biopiracy in the Andes, IIED Sustaining Local Food Systems, Biodiversity and Livelihoods Series, London. Argumedo, A and Stanner, T (2008) ‘Assocation Andes: conserving indigenous biocultural heritage in Peru’, Journal IIED, Gatekeeper Series, No. 137a. Argumedo, A, Swiderska K, Pimbert, M, Song, Y and Pant, R (2011) ‘Implementing farmers’ rights under the FAO International treaty on PGRFA: the need for a broad approach based on biocultural heritage’, Paper prepared for the fourth session of the Governing Body of the International treaty of PGRFA, Bali, 14– 18 March. Bentley JW and Vasques, D (1998) ‘The seed potato system in Bolivia: organisational growth and missing links’, Network Paper No. 85, Agricultural Research and Extension Network, Overseas Development Institute, London. Brush, SB (1991) ‘A farmer-based approach to conserving crop germplasm’, Economic Botany, 45 (2), 153–165. Brush, SB, Carney HJ and Huamán, Z (1981) ‘Dynamics of Andean potato agriculture’, Economic Botany, 35 (1), 70–88. CCTA (2001) ‘Las ferias de semillas’, Cultivos y Saberes: Proyecto conservacion in-situ de cultivos nativos y sus parientes silvestres en el Peru – IIAP-PNUD, No. 6. Devaux, A, Ordinola, M, Flores, R, Hibon, A, Andrade-Piedra, J, Blajos, J and Reinoso, I (2009) ‘Developing a strategic vision for the potato sector in the

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Andean region’, International Society for Tropical Root Crops (ISTRC) Symposium. Hidalgo, OA, Manrique, K, Velasco, C, Devaux, A and Andrade-Piedra, J (2009) ‘Diagnostic of seed potato systems in Bolivia, Ecuador and Peru focusing on native varieties’, Paper presented to the 15th Triennial ISTRC Symposium, Lima. IDRC (2003) Seeds that give: participatory plant breeding – rethinking strategies for agricultural research: global program helps farmers conserve the genetic diversity of crops, Case Study No. 6, IDRC, Ottawa. Iriarte, V, Terrazas, F, Aguirre, G and Thiele, G (2000) ‘Local seed systems and PROINPA’s genebank: working to improve seed quality of traditional potatoes in Bolivia and Peru’, in Friis-Hansen, E and Sthapit, B (eds), Participatory approaches to the conservation of plant genetic resources, IPGRI, Rome. IUCN (1994) Guidelines for protected area management categories, IUCN, Gland, Switzerland and Cambridge, UK. Kneen, B (2009) The tyranny of rights, The Ram’s Horn, Ottawa. Koohafkan, P and Altieri, MA (2011) Globally important agricultural heritage systems: a legacy for the future, FAO, Rome. Marti, N, Argumedo, A and Pimbert, M (2010) Barter markets: sustaining people and nature in the Andes, IIED Sustaining local food systems, agricultural biodiversity and livelihoods, London. Mayer, E (2002) The articulated peasant: household economies in the Andes, Westview Press, Boulder, CO. Mooney, P (1983) ‘The law of the seed: another development and plant genetic resources’, Development Dialogue, 1–2: 1–173. Ruiz, M (2009) Agrobiodiversity zones and the registry of native crops: learning from ourselves, SPDA, Lima. Santilli, Juliana (2012) Agrobiodiversity and the law: regulating genetic resources, food security and cultural diversity, Earthscan, New York, NY. Scurrah, M, Andersen, R and Winge, T (2008) ‘Farmers’ rights in Peru: farmers’ perspectives. Background study 8’, FNI report no. 16, Fridtjof Nansen Institute, Lysaker. Shepherd CJ (2010) ‘Mobilizing local knowledge and asserting culture: the cultural politics of in situ conservation of agricultural biodiversity’, Current Anthropology, 51 (5), 629–654. Solbrig, O and Solbrig, DJ (1994) So shall you reap: farming and crops in human affairs, Island Press, Washington. Swiderska, K, Argumedo, A, Pant, R, Vedavathy, S, Nellithanam, J, Munyi, P, Mutta, D, Song, Y, Herrera, H and Barrios, H (2006) ‘Protecting customary rights over traditional knowledge: implications of customary laws and practices. Interim report’, IIED, London. Tapia, M (2008) Informe de los talleres regionales con campesinos conservacionistas de la agrobiodiversidad en papas, Ministerio de Agricultura, Lima. Tapia, M and De la Torre, A (1998) Women farmers and Andean seeds, FAO/IPGRI, Rome. Tapia, M, Sanchez, P, Caceres, M, Munoz, G and Rosas, A (1997) ‘Experiencias en el manejo de la microcuenca de la encanada: considerada como sitio piloto: (Benchmark site) Cajamarca’, in Tapia, M (ed.), Manejo integral de microcuencas, Centro Internacional de la Papa (CIP), Lima.

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Taylor, E (2008) ‘Sharing benefits or enclosure of the commons? Investigating the compatibility of national and local access and benefit sharing mechanisms in Peru’, Master’s thesis, Saint Mary’s University, Halifax, Nova Scotia. Terrazas, F, Guidi, A, Cadima, X, Gonzales, R, Chaverz, E, Almanza, J, Salazar, M and Baudoin, JP (2005) ‘Conservacion in situ y valoracion de las papas nativas en el Microcentro de Diversidad Genetica de Candalaria, Cochabamba-Bolivia’, Agrociencia, XI, (1 and 2), 135–146. Thiele, G, Gardner, G, Torrez, R and Gabriel, J (1997) ‘Farmer involvement in selecting new varieties: potatoes in Bolivia’, Experimental Agriculture, 33, 275– 290. Thomann, A, Devaux, A, Ordinola, M, Cuentas, M, Urday, P, Sevilla, M and Andrade-Piedra, J (2009) ‘Native potato market chain and poverty reduction: innovation around corporate social responsibility’, Paper presented to the 15th Triennial ISTRC Symposium, Lima. Tobin, B (1993) ‘El problemo del acceso y de los derechos de propiedad intelectual sobre la diversidad biologica’, in Dancourt, O, Mayer, E and Monge, C (eds), Peru el problema agrario en debate: V Seminario Permanente de Investigación Agraria (SEPIA V), Universidad Nacional de San Agustin, Lima. Tobin, B (2009) ‘Setting protection of TK to rights – placing human rights and customary law at the heart of TK governance’, in Kamau, EC and Winter, G (eds), Genetic resources, traditional knowledge and the law: solutions for access and benefit sharing, Earthscan, London. Tobin, B (forthcoming) ‘Why customary law matters: bridging the Nagoya compliance gap’, in Law, Environment and Development (LEAD) Journal. Tobin, B and Taylor, E (2009) Across the great divide: complementarity and conflict between customary law and national sui generis TK law in Peru, SPDA, IDRC, Lima. Virchow, D (1999) ‘Conservation of plant genetic resources for food and agriculture: main actors and the costs to bear’, International Journal of Social Economics, 26 (7/8/9), 1144–1161. Weltzien, E, Smith, ME, Meitzner, LS and Sperling, L (2000) ‘Technical and institutional issues in participatory plant breeding – from the perspective of formal plant breeding: a global analysis of issues, results and current experience,’ Working Document No. 3, CGIAR, Rome.

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Part II

National approaches

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6

Genetic resources common pools in Brazil Juliana Santilli

General overview of ex situ and in situ/on-farm conservation of plant genetic resources for food and agriculture (PGRFA) in Brazil This chapter presents some of the main challenges for the creation and implementation of common pools of genetic resources in Brazil. It discusses the creation of a differentiated access and benefit-sharing (ABS) regime for PGRFA not included in the multilateral system of the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA), as well as the establishment of national benefit-sharing funds. It proposes that genetic resources common pools be created not only through networks of ex situ collections, but also through policies/legal instruments aimed at promoting common pools of genetic resources found in situ/on-farm. It also analyses the possibility of cultural heritage law instruments and ‘agrobiodiversity reserves’ being used to promote and safeguard common pools of genetic resources found in situ/on-farm. Brazil is a megadiverse country and has about 44,000–50,000 species of vascular plants, which represent approximately 18 per cent of the world’s plant diversity (assuming the world’s flora as having about 257,400 species), according to the Brazilian Agricultural Research Corporation Embrapa (2009). Nevertheless, Brazilian agriculture and food security are, to a large extent, dependent on plant genetic resources native to other countries, such as coffee (Ethiopia), rice (Philippines), soybean and oranges (China), wheat (Asia Minor) and sugarcane (New Guinea) (Embrapa 2009). Some native Brazilian species are important for food security at regional and local levels, such as manioc (cassava), pineapple, cashew, cupuaçu, passion fruit, Brazil nut, guaraná, jaboticaba, peanuts, cocoa, some palm species (such as açaí) and other fruit trees. Native forage species are also predominantly used for livestock raising in Brazil, such as cattle (Embrapa 2009). Embrapa coordinates genetic resources ex situ conservation activities through a system called the National Genetic Resources Platform, which feeds/connects a network of 350 active plant germplasm banks, as well a

104 Juliana Santilli Base Collection (long-term conservation), containing 212 genera and 668 species. This whole system provides support to hundreds of genetic breeding programmes developed across Brazil, where research and development have been essentially public (Embrapa 2009). The Base Collection is designed to act as a back-up collection, with duplicates of each access stored in the active plant germplasm banks, which preserve accesses in the field, cold chambers and in vitro (Bustamante and Ferreira 2011). Active germplasm banks provide genetic resources to be used in the short and medium term, for distribution, exchange, multiplication and evaluation. The Base Collection is kept for long-term security in order to preserve the genetic variation for scientific purposes and as a basis for plant breeding. The genetic resources kept in the Base Collection are not drawn upon except for viability testing and subsequent regeneration. The National Genetic Resources Platform also includes initiatives aimed at animal germplasm conservation, divided into: (a) ex situ conservation of animals (outside the habitats where they have developed their adaptive traits) and of their germplasm, through DNA, tissue and germplasm banks; (b) in situ conservation of ‘naturalized’ breeds1 and (c) in situ management of native animal genetic resources (mammals, reptiles, aquatic species and stingless bees), with an economic potential. Brazil also develops animal breeding programmes, most of them for cattle, 2 but there are also specific programmes for buffalo, pigs and poultry (Embrapa 2011a and 2011b). According to Bustamante and Ferreira (2011), 90 per cent of plant access preserved in Embrapa’s Base Collection and germplasm banks correspond to exotic species. Landraces, local varieties and crop wild relatives are also under-represented in such collections. National forestry relies on eucalyptus from Australia and pine trees from Central America and the Caribbean. Cattle raising relies on bovines from India and horses from Central Asia. Fish farming relies heavily on carp from China and tilapia from Eastern Africa. Apiculture is based on varieties derived from the crossbreeding of honey bees of genus Apis, originating from Europe and Tropical Africa (Embrapa 2009). In Brazil, as in most agrobiodiverse countries, native genetic resources are mainly conserved in situ/on-farm,3 and such resources are generally not well-represented in ex situ collections.4 Emperaire (2004), for instance, estimates that the genetic diversity of manioc/cassava found in a traditional agroecosystem in the Negro River Basin (in the Brazilian Amazon) is wider than the genetic diversity found in manioc/cassava ex situ collections of the International Center for Tropical Agriculture (CIAT), in Cali, Colombia. The list of Amazon domesticated plants is long and includes pineapples, açaí, peanuts, papaya, manioc/cassava and pupunha (Neves 2006). The upper Madeira Basin and its tributaries (in the present state of Rondonia) make up the domestication centre for two of the most important plants grown in the Amazon: manioc/cassava and

Genetic resources common pools in Brazil 105 pupunha. Domestication of manioc/cassava led to the development of characteristics such as thicker and longer roots. Besides, Amazonian Indigenous peoples developed sophisticated instruments to turn poisonous plants (certain types of manioc/cassava) into important food products, such as beiju, flour, tapioca, and caxiri (a fermented manioc/ cassava-based drink). Such sophisticated instruments included tipiti (cylindrical and elastic basket made of arumã fiber), and cumatá (large, tightly woven round baskets also made of arumã). Likewise, domestication of pupunha – a type of palm tree whose fruit is widely consumed throughout the Amazon – selected more robust fruit (Neves 2006). Archaeologist Eduardo Neves (2006) explains that, in addition to plant domestication centres, which are already known in the Americas (MesoAmerica and the Andes), the Amazon is gradually gaining recognition as an independent South American plant domestication centre. However, not only the Amazon, but all other Brazilian biomes (Cerrado, Caatinga, Atlantic Forest, Pampa and Pantanal) are home to a great diversity of plant and animal species. On-farm conservation tends to focus mainly on crops of interest to family and small-scale farmers and accomplishes several functions in addition to conservation, such as the political and social empowerment of local farming communities and the improvement of their living conditions. As Clement (2007) explains, ‘so many farmers are involved with on-farm conservation and management of agrobiodiversity because it is intrinsic to their social and economic institutions; conserving the diversity of environmental resources, through time and space, is a major factor of social reproduction’. Besides, the International Treaty on Plant Genetic Resources for Food and Agriculture establishes, in its Article 5.1(c), that member countries (such as Brazil) must promote and support farmers and local communities’ efforts to manage and conserve their plant genetic resources for food and agriculture on-farm. It is the first time that a legally binding international treaty has acknowledged the role of local farmers and communities in the conservation of agrobiodiversity, obliging countries to adopt actions, policies and programmes to support on-farm conservation.

Common pools and the legal status of genetic resources in Brazil One of the main challenges for the creation and implementation of common pools of genetic resources in Brazil is the unclear legal status of these resources. Provisional Act (Medida Provisória) 2186-16 of 2001, which regulates ABS in Brazil, was passed as an expression of the Brazilian state’s sovereign rights over its genetic resources, but it does not define any ownership or proprietary rights of the Brazilian state over its genetic resources5. It is important to keep in mind that sovereign rights and property rights are distinct concepts, which cannot be confused: exercising

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their sovereign rights over natural resources found in their territories, countries may decide that certain natural resources (such as genetic resources) are public property (or state property), but not necessarily. Genetic resources are, from a legal point of view, treated differently from the plants (or animals) that contain them. Different ownership regimes are applied to plants or animals, considered in themselves as biological resources, and to their genetic resources. Private or public ownership of an animal or plant does not necessarily lead to the same ownership regime of its genetic resources.6 Access and use of genetic resources, whether privately or publicly owned, are subject to regulation in the public interest. The sharp duality between private and public resources has been increasingly overcome by environmental law, as any environmental resources (such as water, land, forest resources, etc.) have their utilization restricted by environmental regulations, independent of their being privately or publicly owned. In Brazil, most stakeholders agree that genetic resources are public interest resources, and that they have social, cultural and economic value for the whole society and not just for the owners of the areas where they are located, whether public or private. This is, however, still not explicit in the Brazilian national ABS law. On the contrary, Provisional Act 2186-16/2001 tends to adopt a very privatist stance in relation to genetic resources, and private owners of lands (where genetic resources are found in situ) end up receiving most of the benefits arising from the utilization of genetic resources. There is no legal guarantee that such benefits will be directed into biodiversity conservation.7 According to Article 16, §9, III, of Provisional Act 2186-16/2001, private landowners must give their prior consent to any access to genetic resources located on their lands.8 CGEN’s (the Brazilian Council on Genetic Resources Management) Resolution No. 8/20039 has partially mitigated such a stance: it states that when access to genetic resources for scientific research (with no commercial purpose) is considered to be of ‘relevant public interest’ and to ‘contribute to enhance knowledge about biodiversity’, the private landowner’s consent to access may not be required. However, it is not clear what such expressions actually mean (what types of scientific research are considered to be of ‘relevant public interest’ and to ‘contribute to enhance knowledge about biodiversity’), and such exemption has never been applied in practice.10 Not only plant genetic resources, but also animal genetic resources have an unclear legal status in Brazil: wild animals belong to the federal state and domesticated farm animals belong to their private owners. Such public and private ownership rights, however, refer to the animals themselves (as biological resources), not to their genetic resources, as we have already mentioned. The Convention on Biological Diversity (CBD) establishes sovereign rights over ‘genetic resources’, which are defined as ‘genetic material of actual or potential value’. ‘Genetic material’ is defined as ‘any material

Genetic resources common pools in Brazil 107 of plant, animal, microbial or other origin containing functional units of heredity’. This means that animal genetic resources are included in the ABS regime established by the CBD, and that the CBD’s regulations on conservation and sustainable use of genetic resources also apply to animal genetic resources. The Brazilian ABS law (Provisional Act 218616/2001, Article 7, I) also explicitly includes animal genetic resources in its scope. Some authors understand that there is a conflict between the CBD’s ABS regime and national laws establishing private ownership of animals or their genetic resources. Ivanković (2008), for instance, believes that private ownership of animal genetic resources can be a challenge for fair and equitable benefit sharing (in accordance with the CBD), as current practice is that only the owner of the animal may decide to sell the animal and with it the animal genetic resources involved, and under which conditions. This would mean that access to animal genetic resources is governed only by, and might be hampered by, the private ownership of animals and, as a consequence, free/facilitated access to animal genetic resources would require that the animals be publicly owned. However, private ownership of domesticated animals does not prevent national laws from establishing that access and use of animal genetic resources in certain public-interest circumstances are not solely at the discretion of the animal’s owner (for instance, in the case of rare breeds or of breeds threatened by extinction, where there is a public interest in conserving genetic material). Public breeding programmes11 may need to access certain animal genetic resources, even if they are in the private domain. Such access must be ensured by law, and it cannot be prevented by private owners of animals to the detriment of public values such as livestock diversity conservation and sustainable use, food and nutritional security, health and environmental sustainability.

The implementation of international and national common pools of genetic resources for food and agriculture in Brazil The international multilateral system of ABS and Brazil So far, the only common pool of genetic resources that is legally in force in Brazil is the multilateral system of access and benefit sharing for plant genetic resources for food and agriculture (PGRFA) established by the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA). This system establishes an international common pool for 64 crops listed in Annex I of the Treaty.12 Brazil signed this Treaty on 10 June 2002, and ratified it on 22 May 2006.13 Manioc/cassava (Manihot esculenta) is the only crop included in the multilateral system of the ITPGRFA whose centre of origin and diversity is Brazil. During the negotiations on the Treaty, the inclusion of peanuts (whose centres of origin and diversity are

108 Juliana Santilli Brazil and Bolivia) in the multilateral system was considered, but they ended up being excluded. As Brazil has ratified the ITPGRFA, the special rules of its multilateral system on access and benefit sharing apply for Brazil in regard to Annex I crops, conserved ex situ and in the public domain. However, there is no specific ABS regime for other PGRFA (i.e. those not included in the multilateral system or found in situ/on-farm). The bilateral system established under Provisional Act 2186-16/2001 was developed in response to CBD and not to the ITPGRFA. Provisional Act 2186-16/2001 was conceived mainly for wild biodiversity, particularly for chemical, pharmaceutical, and/or other non-food/feed industrial uses, with very little consideration for the specific nature of domesticated biodiversity. Nevertheless, Provisional Act 2186-16/2001 sets out, in Article 19.2, that any transfers of genetic resources of species included in international agreements aimed at facilitating the exchange of genetic resources will be made in accordance with the conditions established in such international agreements, and not in accordance with the ABS bilateral system established by Provisional Act 2186-16/2001. This means that any transfers of genetic resources involving the 64 crops listed in Annex I of the ITPGRFA, which are conserved ex situ and in the public domain, will be made according to the rules of its multilateral ABS system, without the need of ABS bilateral contracts. Brazil was one of the countries whose national ABS law has, since 2001, taken into account the need to implement the Treaty’s multilateral ABS system. This happened because the ITPGRFA was already being negotiated at the international level when Provisional Act 2186-16/2001 was enacted. However, Brazil does not have a national common pool of plant genetic resources for food and agriculture, created legally as such. The CBD bilateral system, through which access to genetic resources and traditional knowledge is negotiated on a case-by-case basis, through bilateral contracts between providers and users of such resources, established by Provisional Act 2186-16/2001, applies to all non-Annex I crops and to all plant genetic resources found in situ/on-farm. Authorization is legally required for access to Brazilian native PGR and to associated traditional knowledge held by indigenous and local communities but not required for exotic PGR, if they were not collected from in situ conditions in Brazil. Access authorization is also required for exotic PGR, which have developed ‘distinctive properties’ in Brazil (a controversial issue, still not totally decided by CGEN), and for local/traditional/creole varieties (which are considered to incorporate traditional knowledge (TK) in themselves) and in cases involving access to associated TK. National common pools of genetic resources and benefit-sharing funds In this chapter, we will discuss the creation of a differentiated ABS regime for PGRFA not included in the multilateral system of the ITPGRFA, as well

Genetic resources common pools in Brazil 109 as the establishment of national benefit-sharing funds for plant and animal genetic resources. Common pools of plant genetic resources Brazil, like all countries that are parties to the ITPGRFA, cannot create ABS rules for crops included in Annex I, held in ex situ public collections, differing from those of the multilateral system. All countries that are parties to the Treaty can voluntarily include their ex situ public collections of non-Annex I crops in the multilateral system,14 but Brazil and most highly biodiverse countries are unlikely to do this until benefit-sharing mechanisms under the multilateral system prove to be effective and equitable. However, Brazil and other highly biodiverse countries could (and should) establish a differentiated ABS regime for PGRFA not included in the multilateral system of the ITPGRFA, found in situ or ex situ. It could be a specific ABS system for PGRFA, different from the general ABS bilateral systems used for wild biodiversity. One alternative would be to establish a national common pool of plant genetic resources for food and agriculture and to create one or several national benefit-sharing fund(s). All benefit sharing would be directed into such collective national benefit-sharing funds instead of being negotiated on a bilateral and case-by-case basis. Common pools would cover all PGRFA that are not included in the international multilateral ABS system. The administration of national benefit-sharing funds could be carried out by representatives of smallscale and local/traditional farmers who conserve agrobiodiversity in situ/ on-farm. The latter should be the main beneficiaries of the resources directed into such national benefit-sharing funds. A certain percentage of the value of all seeds that are sold in the country could be directed into a national benefit-sharing fund, or to several national benefit-sharing funds established in different regions of the country. These funds would be paid directly by the national and international private seed sectors, as a special tax/contribution imposed upon users of plant genetic resources. The Norwegian government pays the equivalent of 0.1 per cent of the value of sales of seeds of all PGRFA in the country to the benefit-sharing fund of the ITPGRFA. It is not a tax/contribution paid directly by the private seed sector; such value is donated by the Norwegian government to the benefit-sharing fund of the ITPGRFA. However, it is unlikely that in developing countries governments would be willing to make such payments because of a lack of public funds. Such a tax/contribution would have to be paid directly by the national and international private seed companies who access genetic resources and be deposited in national benefit-sharing funds. The payment of a fixed percentage of all seed sales should be mandatory regardless of the availability of genetic resources to third parties for further research and breeding. Benefit sharing should

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not have any connection to intellectual property (IP) rights, because such a connection would end up raising too much controversy as to who is and who is not obliged to share benefits arising from the commercialization of seeds. Currently, the benefit-sharing fund established by the ITPGRFA receives very few resources, since benefit sharing is mandatory only when commercialized products (that incorporate material accessed from the multilateral system) are not available without restrictions (including legal restrictions, such as IP rights) to others for further research and breeding. National benefit-sharing funds should not have such a limitation. Regional benefit-sharing funds covering genetic resources that occur in transboundary situations could also be created. A national benefit-sharing fund based on a fixed percentage of the value of all seed sales to be paid by users of plant genetic resources would be a mechanism to implement the user pays principle, a variation of the polluter pays principle, which requires that the costs of pollution be borne by those who cause it. The user pays principle, however, applies the polluter pays principle more broadly, because it requires that the cost of a resource to a user include all the environmental costs associated with its use. The main goal of the user pays principle is to internalize the environmental externalities of economic activities, so that the real value of the environment, and components of it, are reflected in the costs of using it. It is a tool of distributional justice, so that the user of a (natural) resource pays directly for such a use, rather than the cost being shared by the whole society. As Leme Machado (2003) explains, the user pays principle is not a punishment, since it is not applied only when pollution or illegal use or damage of a natural resource occurs. It aims at internalizing external environmental costs every time a natural resource is used for private purposes. The polluter pays/user pays principle was recognized by the Rio Declaration on Environment and Development, approved by the 1992 UN Conference on Environment and Development (the Earth Summit). The Rio Declaration consisted of 27 principles intended to guide future sustainable development around the world. According to its Principle 16: National authorities should endeavor to promote the internalization of environmental costs and the use of economic instruments, taking into account the approach that the polluter should, in principle, bear the cost of pollution, with due regard to the public interest and without distorting international trade and investment. This is referred to in both Agenda 21 and the World Summit on Sustainable Development (WSSD) Johannesburg Plan of Implementation. In Brazil, the National Environmental Policy Law (Law 6938/1981, Article 4, VII) explicitly recognizes the user pays principle, which determines that users of environmental resources with economic

Genetic resources common pools in Brazil 111 purposes must contribute to their conservation. This principle is also adopted in the Brazilian National Water Resources Policy (Law 9433/1997), which obliges users of water resources with economic purposes to pay economic contributions to the agencies in charge of managing water resources. The user pays principle aims at internalizing environmental costs of economic activities. Based on this principle, users of plant genetic resources should also contribute to their conservation, through ex situ, in situ/on-farm strategies. Their contribution should be based on the principle that, as private users of plant genetic resources for their economic activities, they must contribute to public interest initiatives aimed at conserving and managing genetic diversity. Since the user pays principle is broader than the polluter pays principle, as explained above, the contribution of users of plant genetic resources must not be measured in terms of the environmental impact of their activities. The use of genetic resources for private economic activities must require a contribution to their conservation based on the value of profits made with the use of such resources (that is, a fixed percentage on the value of all seed sales to be paid by all users of plant genetic resources). Thus, a fixed percentage of the value of seed sales should go to a national benefit-sharing fund, managed with the participation of representatives of local, family and traditional farmers, and aimed at supporting plans and programmes for on-farm conservation and sustainable use of agrobiodiversity and the implementation of farmers’ rights. This form of benefit sharing is more consistent with the nature of plant genetic resources for food and agriculture than trying to identify, on a case-by-case basis, the ‘providers’ of resources. Small-scale and traditional farmers could present their proposals for projects to be supported by the national benefit-sharing fund according to the criteria established by the administrators of the fund. The creation of a national benefit-sharing fund is currently being discussed by the Brazilian ministries of Agriculture, Environment and Science and Technology, but so far (January 2013), no concrete steps have been taken. Brazil and other highly biodiverse countries could also establish some important reciprocity rules in their national ABS laws for PGRFA that the international multilateral system was unable to introduce due to lack of consensus. For instance, they could establish that access to ex situ collections held by public institutions is granted only to private institutions that also make their ex situ collections available to public institutions for plant breeding and research. In addition, national ABS laws could establish that private institutions can access plant genetic resources found in situ on public domain lands only if they commit themselves through a legally binding instrument to make such resources available to public institutions. Access to genetic resources for public research would thus be guaranteed.

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One important rule to protect national common pools of genetic resources and ensure adequate benefit sharing should be that users cannot claim any intellectual property rights (IPRs) over such resources (Article 12.3(d) of the ITPGRFA establishes a similar rule). However, if they do claim such monopolistic rights, limiting the access of other users to the same resources (on common pools), such titles (patents, breeders’ rights, etc.) should be declared null and void (with retroactive effects), through administrative and/or judicial procedures, and checkpoints should also be established. Any revenue arising from the commercialization of resources that are illegally protected by IPRs (because they belong to national common pools, and therefore cannot be privately appropriated) should be expropriated and directed into national benefit-sharing funds. Patent offices in both provider and user countries should be legally obliged to require, from anyone who claims a patent over processes or products originating from genetic resources, to disclose the origin of such genetic resources and of associated traditional knowledge. This would be an efficient way of ensuring that no resources belonging to national common pools are illegally appropriated. The contribution of users of genetic resources to national benefitsharing funds should be based on a fixed percentage of the value of all seed sales, whether a substantial or a small part of the accessed genetic resources was incorporated into the final product. It would be extremely complex to determine how each resource contributed to the specific traits of final products developed by users of genetic resources and to establish different criteria for each contribution to the fund. Common pools of animal genetic resources International and national legal regimes of common pools of animal genetic resources for food and agriculture could also be established through networks of public ex situ collections (currently, there are very few, but they could be created) and the creation of programmes aimed at supporting on-farm conservation by livestock keepers. So far, the ITPGRFA is the only international ABS specialized regime and there is no international agreement dealing specifically with ABS in relation to animal genetic resources. Likewise, livestock keepers’ rights15 are not recognized in any legally binding international instrument. There is no multilateral system regulating the international exchange of animal genetic resources, such as the one existing for plants. However, the Nagoya Protocol explicitly allows the development of other specialized, international ABS instruments (Article 4.2). An international multilateral ABS regime for animal genetic resources for food and agriculture and an international benefit-sharing fund could be established, tailored to the specific needs of the livestock sector. National benefit-sharing funds, benefiting mainly livestock keepers and pastoral communities, could also

Genetic resources common pools in Brazil 113 be established, aimed at promoting the conservation and sustainable use of livestock diversity. International and national benefit-sharing funds would contribute to ensure effective implementation of many objectives of the Global Plan of Action for Animal Genetic Resources,16 such as conservation, sustainable use and development of animal genetic resources, and the development of adequate policies, institutions and capacities. The debate on the integration of animal genetic resources into the ABS system is still in its initial stages (Biber-Klemm and Temmerman 2010a, 2010b; Hiemstra et al. 2006), but in the future, animal genetic resources from any part of the world may prove vital to breeders and livestock keepers elsewhere, and there is a need for the international community to accept responsibility for the management of these shared resources, as the State of the world’s animal genetic resources (FAO 2007)17 points out. Equitable frameworks for access and for sharing the benefits derived from animal genetic resources need to be put in place, both at the national and international levels. The creation of international and national common pools and benefit-sharing funds for animal genetic resources could be interesting tools in this direction.

Farmers’ rights and genetic resources common pools Genetic resources common pools must be created not only through networks of ex situ collections, but also through policies/legal instruments aimed at promoting common pools of genetic resources found in situ/onfarm. The realization of farmers’ rights (recognized by the ITPGRFA) and of livestock keepers’ rights is essential to ensure the conservation and sustainable use of agrobiodiversity. Equally essential for conservation and sustainable use of agrobiodiversity is the establishment of international and national common pools of plant and animal genetic resources conserved in situ/on-farm. According to Article 9 of the ITPGRFA, farmers’ rights include: (a) protection of traditional knowledge relevant to plant genetic resources for food and agriculture; (b) the right to equitably participate in sharing benefits arising from the utilization of plant genetic resources for food and agriculture; and (c) the right to participate in making decisions at the national level on matters related to the conservation and sustainable use of plant genetic resources for food and agriculture. In addition, Article 9 sets out that the Treaty’s provisions may not be interpreted to limit any rights that farmers have to save, use, exchange and sell farm-saved seed, according to national laws. Although the Treaty acknowledges that countries must adopt measures to protect farmers’ rights, each country may decide which measures to adopt, and policies and actions listed in the Treaty are illustrative, allowing countries to adopt other types of measures. There are different approaches for the implementation of farmers’ rights, which will have a direct impact on the development of common

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pools of genetic resources found in situ/on-farm. Andersen (2006) identifies two approaches to the understanding of farmers’ rights: the ownership approach and the stewardship approach. Andersen (2006) argues that the ownership approach refers to the right of farmers to be rewarded for genetic material obtained from their fields and which is used in commercial varieties and/or protected with IP rights. The idea is that such a reward system is necessary to enable equitable sharing of benefits arising from the use of agrobiodiversity. Access and benefit-sharing legislation and farmers’ IP rights are suggested as central instruments, meaning that farmers would be rewarded through bilateral benefit-sharing contracts. The stewardship approach refers to the rights that farmers must be granted to continue as stewards of agrobiodiversity. The idea is that the legal space required for farmers to continue this role must be upheld and that farmers involved in the maintenance of agrobiodiversity – on behalf of our generation, for the benefit of all humankind – should be rewarded and supported for their contributions (Andersen 2006). Andersen (2006) argues that the stewardship approach is most adequate if farmers’ rights are to be realized within the framework of the ITPGRFA, since benefits should be shared between stewards of plant genetic resources and society at large (through the multilateral ABS system of the ITPGRFA and other collective mechanisms). The ownership approach, on the other hand, understands that benefits are to be shared between purported ‘owners’ and ‘buyers’ of genetic resources upon prior informed consent on mutually agreed terms. It must be added, however, that a stewardship approach to farmers’ rights is also essential for the development of common pools of genetic resources managed in situ/on-farm by local farmers and livestock keepers. Farmers’ and livestock breeders’ rights should be recognized as essentially collective and not individual rights. The rights of farmers and pastoral communities to be rewarded and supported for their contribution to the global pool of genetic resources should be implemented through public policies aimed at valuing and strengthening local and traditional agricultural and pastoral systems and through collective benefit-sharing mechanisms, not through bilateral contracts between providers and users of genetic resources. Collective benefit-sharing mechanisms may include, among others: strengthening local/traditional farmers’ capacity to participate in local and national agricultural markets; promoting participatory plant breeding, seed fairs and local seed banks, as well as seed exchange networks; recognizing agrobiodiverse traditional/local agricultural systems as biocultural heritage (Argumedo et al. 2011) and as cultural landscapes; promoting geographical indications to enhance the value of biodiversity products; allowing farmers to participate in all decision-making processes at the international, national, regional, and local levels; ensuring collective payments for agrobiodiversity conservation services; etc. As already mentioned above, establishing national benefit-

Genetic resources common pools in Brazil 115 sharing funds to support on-farm conservation and sustainable use of agrobiodiversity can also be an interesting collective benefit-sharing mechanism.

Cultural heritage law instruments and common pools In safeguarding traditional/local agricultural systems, and the rich biodiversity and cultural diversity that they encompass, cultural heritage law instruments could be used to promote and safeguard common pools of genetic resources found in situ/on-farm. Furthermore, they could be valuable in ensuring that the social and cultural processes that maintain such genetic resources in (local) common pools are safeguarded and legally protected. Such instruments may also be used to prevent private misappropriation of collective resources and knowledge, traditionally shared according to local rules and social networks. Agrobiodiversity and cultural heritage law According to Carl Sauer (1986), cultivated plants are ‘cultural artifacts’, and to Laure Emperaire (2008), they are ‘biological objects in nature, but cultural in essence’. Culture is even present in the term ‘agriculture’ and the word ‘culture’ has historically also meant cultivation of the land. Culture and agriculture are therefore intimately related and we can use legal instruments aimed at safeguarding cultural heritage to recognize and promote agrobiodiversity-rich agricultural systems and all their elements, both tangible (such as agroecosystems and cultivated plants) and intangible (agricultural techniques, practices and knowledge). Safeguarding traditional foodways and dietary diversity is also an important way to promote agrobiodiversity and food security. The conservation of crop genetic diversity cannot be dissociated from crop use, including in human diets. Promoting traditional diets, which are generally more diverse, contributes to safeguarding humanity’s biological and cultural heritage at the same time. Therefore, cultural heritage legal instruments – such as the UNESCO (United Nations Educational, Scientific and Cultural Organization) Convention for the Protection of the World Cultural and Natural Heritage and the UNESCO Convention for the Safeguarding of the Intangible Cultural Heritage – can be used (and in some cases, have been used) to promote agrobiodiversity and food diversity in different and innovative ways. Historically, UNESCO’s Representative List of Intangible Cultural Heritage has focused primarily on performing arts and crafts. More recently, however, UNESCO seems to have accepted that culinary traditions are a cultural expression as fundamental to identity and worthy of recognition as dance, theatre or music. As food heritage is directly associated with crop genetic diversity, it is worth mentioning that in 2010

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three culinary systems were included in UNESCO’s Representative List of Intangible Cultural Heritage: the traditional Mexican cuisine; the Mediterranean diet of Spain, Greece, Italy and Morocco; and the gastronomic meal of the French.18 UNESCO is also partnering with Biodiversity International and the Kenyan Ministry for National Heritage and Culture on a project called ‘Safeguarding Traditional Foodways of Two Communities in Kenya’. The project recognizes that traditional foodways, both those related to everyday life as well as those associated with special occasions (such as rituals and festive events), constitute an important part of the intangible heritage of local communities.19 Another initiative in the same direction took place in Brazil on 8 November 2010. The Brazilian Federal Agency for Cultural Heritage Protection (IPHAN) recognized, for the first time, an agrobiodiversityrich traditional agricultural system as ‘intangible cultural heritage of Brazil’: the traditional agricultural system of the Negro River region, in the northwest of the Brazilian Amazon. According to Laure Emperaire, Lúcia Van Velthem and Ana Gita de Oliveira (Emperaire et al. 2008), in the context of the Negro River, an agricultural system may be understood as ‘a whole set of knowledge, myths, oral expressions, practices, products, techniques, artifacts and other associated manifestations and expressions which involve the management of spaces, the cultivation of plants, the transformation of agricultural products and local food systems’. These authors explain that the notion of system links cultural heritage, to which recognition is sought, to a wider and more complex set of social relationships. To Emperaire et al. (2008), the Registry of the Negro River agricultural system as intangible cultural heritage is ‘a concrete example of how instruments and policies for safeguarding cultural heritage can be used in favour of agrobiodiversity, cultural diversity and local agricultural systems’. On 23 December 2009, Peru issued National Directorial Resolution (Resolución Directoral Nacional20) No. 1986/INC, declaring as ‘national cultural heritage’ the knowledge, practices and technologies associated with the traditional cultivation of maize in the Sacred Valley of the Incas in the Andes of Peru. This was also the first time that an agricultural system was recognized as cultural heritage in Peru. According to the above-mentioned Resolution, maize or Sara (in the Quechua language), despite being a cereal of Meso-American origin, has been cultivated in the Peruvian Andes for millennia, and 55 local maize varieties can be found in this region. It is also worth mentioning that in 1992, the UNESCO Convention on the Protection of the World Cultural and Natural Heritage (known as the World Heritage Convention), established a new and innovative category of protected sites: the ‘cultural landscape’.21 Cultural landscapes are justifiably included in the UNESCO World Heritage List when interactions between people and their environment are evaluated as being of

Genetic resources common pools in Brazil 117 ‘outstanding universal value’. Some important agricultural landscapes have been inscribed under the World Heritage List as cultural landscapes such as the rice terraces of the Philippine Cordilleras; the archaeological landscape of the first coffee plantations in the southeast of Cuba; the agricultural landscape of southern Öland in Sweden; and the Puszta pastoral landscape of Hortobagy National Park in Hungary. These examples show the possibility of using the cultural landscape category to promote and safeguard agrobiodiversity heritage sites (Singh and Varaprasad 2008). Thus, the rich genetic heritage of crops and livestock associated with diverse agroecosystems as well as agricultural techniques, practices and innovations held by local communities can be protected not only through environmental law instruments but also via cultural heritage safeguarding tools. In addition to cultural landscapes ‘of outstanding universal value’ recognized by UNESCO’s International Convention on World Heritage, Brazil created a national legal instrument for the recognition of Brazilian cultural landscapes known as chancela (which can be translated as a seal, an official stamp or certificate granted to some cultural landscapes of particular value). Brazilian cultural landscapes are regulated by Administrative Order (Portaria) No. 127 of 30 April 30 2009, 22 issued by the President of IPHAN. According to this Administrative Order, a Brazilian cultural landscape is a ‘peculiar portion of the national territory that is representative of the process of interaction of man with the natural environment, in which life and human science have made their marks or attributed values’. The ‘Brazilian cultural landscape’ is declared by a seal instituted by IPHAN, and any citizen is entitled to request the opening of an administrative process aimed at awarding a ‘Brazilian cultural landscape’ seal to a specific site. The seal establishes a pact among government, civil society and private companies aimed at collectively managing the portions of the national territory that have been recognized as cultural landscapes. A management plan of such cultural landscapes must be developed through partnerships between these different stakeholders. The seal must take into consideration the dynamism of culture and human activity and must be revalidated after a maximum of ten years. The objective of the seal is to contribute to the preservation of cultural heritage, complementing other existing safeguarding instruments. On 3 May 2011, IPHAN, for the first time, granted the ‘Brazilian Cultural Landscape’ seal to specific sites: the rural communities of Testo Alto in the municipality of Pomerode and Rio da Luz in the municipality of Jaraguá do Sul, in the Itajaí Valley in the state of Santa Catarina (southern Brazil). This is an important region for the conservation of agrobiodiversity and associated cultural diversity. In the Itajaí Valley, the small rural properties run by small-scale family farmers have been the key elements for development and sustainability of the rural properties since

118 Juliana Santilli the colonial period. Even when immigrant colonies became economically developed and some of their members became wealthy, agricultural miniproperties remained the main basis for the agricultural production system. All houses have vegetable gardens containing tomatoes, cabbage, collard greens, lettuce, pumpkins, cucumbers, peanuts, peppers and herbal spices – all of which are abundantly used in meals – and orchards in the backyards with avocados, persimmons, carambolas (starfruit), jaboticabas (a tough-skinned purple grape-like tropical fruit grown in Brazil), pitangas (a Brazilian spicy red fruit), oranges, lemons, guavas and araçás (a yellow fruit that resembles a guava, but with a more acidic flavour). Banana trees and sugarcane are ubiquitous, and hearts of palm (from palm trees) are saved for special occasions. Because of its limitless uses, bamboo is indispensable. In areas of Polish and Italian immigration, grapevines are almost mandatory, enabling the production of traditional home-made wines (IPHAN 2007). This is an example of the potential use of the cultural landscape category to protect traditional and local agricultural systems. The seal (chancela) must not be confused, however, with trademarks nor with geographical indications, which serve different purposes. Recognition of a certain portion of Brazilian territory as a cultural landscape, through the above-mentioned seal, creates an obligation for public agencies to develop policies, actions and management plans aimed at safeguarding its characteristic features and resources. Like Brazil, other countries could use the seal of cultural landscapes as an instrument to protect local and traditional agricultural systems which are rich in agrobiodiversity and representative of the country’s cultural diversity.

Agrobiodiversity and protected areas The role of protected areas in promoting the conservation and sustainable use of agrobiodiversity has been greatly underestimated. At the international level, there is still no specific category of protected area for agrobiodiversity conservation, whether for in situ conservation of crop wild relatives or for on-farm management of agrobiodiversity-rich farming systems. The International Union for Conservation of Nature’s (IUCN) protected areas categories V and VI (‘protected landscapes/seascapes’ and ‘protected area with sustainable use of natural resources’ respectively), as well as UNESCO’s biosphere reserves, have occasionally been used for agrobiodiversity conservation, but they were not conceived for this specific purpose. The number of protected areas in the world has grown from approximately 56,000 in 1996 to about 70,000 in 2007, and the total area covered has expanded in the same period from 13 to 17.5 million km2, but areas with the richest agrobiodiversity (such as of origin and/or diversity) have received significantly less protection than the global average,

Genetic resources common pools in Brazil 119 according to The second report on the state of the world’s plant genetic resources for food and agriculture (FAO 2010). This report adds that a significant number of plant genetic resources for food and agriculture (PGRFA), including crop wild relatives and useful plants collected from the wild occur outside protected areas (in cultivated fields, orchards, grasslands, etc.) and consequently do not receive any form of legal protection.23 As several authors have already pointed out (Phillips 2005; Rössler 2005; Santilli 2005), there has been a shift in the conservation paradigm, from designating exceptional natural sites without people (pristine or near-pristine areas) to recognizing the value of natural heritage sites in a landscape context that includes people. That is, more emphasis has been placed on human–nature interaction, and the importance of protected areas that focus on lived-in landscapes has been increasingly recognized. Following this trend, an agrobiodiversity reserve (or heritage site) or a protected ‘agrobiodiverse landscape’ category could be created focusing specifically on the management of agricultural biodiversity and on the recognition of traditional agricultural techniques, practices and knowledge. Most initiatives to conserve agrobiodiversity inside protected areas have taken place in parks, biological reserves, etc., which were not conceived for the conservation of crops and cultivated areas. Some exceptions are the Parque de la Papa, created by Indigenous communities of Peru and the Sierra de Manantlán Reserve in Mexico. The creation of an internationally recognized, protected area category especially aimed at conserving agrobiodiversity would help to promote public awareness about the importance of agricultural diversity and its implications for food security, nutrition, health, social equity and environmental sustainability. Historically, most conservation efforts and policies have focused on wild biodiversity, as if conserving wild plants and animals were more important to humanity than conserving the diversity of agricultural crops such as rice, beans, corn and potatoes, which are part of our day-to-day diets. In addition, the lack of an integrated approach to agricultural and environmental policies leads, in many cases, to separate and unarticulated efforts to conserve threatened wild species and ecosystems by environmental agencies, and ex situ conservation of crops by agricultural research institutions without much interaction between them. The creation of agrobiodiversity reserves would also draw more attention from policy makers to the relevance of identifying ‘agrobiodiversity hotspots’, surveying and making inventories of areas with high agricultural diversity (especially crop wild relatives, traditional/local landraces and ingenious farming systems), and defining criteria and methods for the identification and adaptive management of such areas. Through these initiatives, scientific understanding of on-farm management of agrobiodiversity would increase as would recognition of the value of local seed systems and social networks in maintaining plant genetic diversity. A category of protected area especially designed to

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promote on-farm management of agrobiodiversity should allow sustainable use of plant genetic resources and focus on the interaction between humans and nature and on adaptive management, which generally does not occur with conventional protected areas categories. As it is traditional and local, agricultural systems that conserve and manage most agricultural diversity, an agrobiodiversity reserve could be created only with the support and involvement of farmers who live in the designated area. The involvement of farmers would also be essential in the development and implementation of management plans and actions promoting an integrated and complementary approach to scientific and traditional knowledge systems. Agrobiodiversity reserves must meet broader objectives of sustainable local development and social inclusion rather than just environmental conservation in order to be socially and politically sustainable, especially in developing countries. Agrobiodiversity reserves need not necessarily be established in publicly owned lands, and it does not make sense, evidently, to expropriate the lands of farmers within their limits. Agrobiodiversity reserves could be established through agreements with local farmers who live in the designated areas and manage agrobiodiversity-rich agroecosystems. They could be compensated for the conservation of crop diversity, for instance, through the payment of environmental services.

Conclusion The only common pool of genetic resources that is legally in force in Brazil is the multilateral system of access and benefit sharing for plant genetic resources for food and agriculture established by the ITPGRFA. This system establishes an international common pool, but there are no national common pools of plant genetic resources (or of any other genetic resources) legally created as such in Brazil. National common pools of plant and animal genetic resources for food and agriculture could be established through the creation of national benefit-sharing funds, administered by representatives not only of governments, but also of small-scale and local/traditional farmers and livestock keepers, who conserve agrobiodiversity in situ/on-farm, and must be the main beneficiaries of the resources directed into benefit-sharing funds. Common pools of genetic resources should be promoted not only through networks of ex situ collections, but also through initiatives aimed at safeguarding common pools of genetic resources found in situ/on-farm, which are managed through social networks and according to local institutions. On-farm conservation focuses mainly on crops of interest to family and small-scale farmers, and accomplishes several functions, in addition to conservation, such as the political and social empowerment of local farming communities and the improvement of their living conditions.

Genetic resources common pools in Brazil 121 The realization of farmers’ rights (recognized by the ITPGRFA) and of livestock keepers’ rights (still not formally recognized in any international instrument) is essential to ensure the conservation and sustainable use of agrobiodiversity, as well as to establish international and national common pools of plant and animal genetic resources, conserved in situ/on-farm. Despite not having been created for this specific purpose, the registry of intangible cultural heritage and the safeguarding of cultural landscapes (cultural heritage law instruments), as well as the creation of agrobiodiversity reserves, could be used to promote and safeguard common pools of genetic resources found in situ/on-farm, as well as to implement farmers’ rights through a stewardship approach.

Notes 1

2 3

4

Most domesticated animal species were introduced in Brazil by colonizers, but they were submitted to natural selection and developed adaptive traits to certain ecological niches and began to be called ‘naturalized’, creole or local breeds. Brazil has the largest commercial cattle herd in the world, second in numbers only to India, which, for religious reasons, does not use its cattle herd commercially (Embrapa 2003). Some authors see conservation as a type of in situ conservation, and the expression ‘on-farm in situ conservation’ is very commonly used. Others believe that the term in situ refers mainly to conservation of wild species in their natural habitats, and that when domesticated species are managed by farmers in local agroecosystems it is more appropriate to use the expression ‘on-farm conservation’. Walter de Boef prefers to use the expression ‘community biodiversity management’, pointing out that the term ‘management’ is more appropriate than ‘conservation’, because it better reflects the dynamic nature of human and ecological processes, which cannot be controlled or ‘conserved’. ‘Conservation’ is a concept developed by conservationists rather than a goal of farmers (De Boef 2000). It is very difficult, and perhaps impossible, to determine how representative ex situ collections are of the total agricultural diversity found in situ/on-farm in Brazil. All over the world, about 7.4 million plant accessions are currently conserved in germplasm banks, that is, in ex situ collections. However, these accessions represent a limited number of major crops, and about 45 per cent of all the accessions in the world’s genebanks are cereals. Food legumes are the next largest group, accounting for about 15 per cent of all accessions, while vegetables, fruits and forage crops each account for 6–9 per cent of the total number of accessions maintained ex situ. Roots and tubers, as well as oil and fibre crops, each account for 2–3 per cent of the total (according to The second report on the state of the world’s plant genetic resources for food and agriculture (Commission on Genetic Resources for Food and Agriculture 2010). Other limitations of ex situ collections include the fact that some seeds cannot withstand very low humidity and/or are not resistant to temperatures below 0°C and therefore cannot be stored in cold chambers (called recalcitrant seeds). Vegetative propagation species (such as potatoes, yams, manioc/ cassava, etc.) must also be conserved in field or in vitro collections, making ex situ conservation more expensive, complex and difficult to implement in poor countries.

122 5

6 7

8 9 10

11 12 13 14 15

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Decision 391 of the Andean Community and the Ethiopian Proclamation (482/2006), for example, recognizes genetic resources as the property of the state. In Brazil, a proposal (bill) for a constitutional amendment that turns genetic resources into federal public domain resources is being discussed at the Brazilian Congress, but there is very little political support for such a proposal, and it is very unlikely that it will be approved (as of April 2011). The same happens, for instance, with mineral resources: according to Brazilian law, the property of the land is distinct from the property of mineral resources, which belong to the federal state. The Nagoya Protocol establishes in Article 9 that parties must ‘encourage users and providers to direct benefits arising from the utilization of genetic resources towards the conservation of biological diversity and the sustainable use of its components’. So far, this orientation has not been turned into practice in Brazil. Provisional Act (Medida Provisória) 2186-16, 2001, the Brazilian ABS law, http://www.mma.gov.br/estruturas/sbf_dpg/_arquivos/mp2186i.pdf, viewed 20 March 2012. Resolution No. 8/2003, CGEN, http://www.mma.gov.br/estruturas/sbf_dpg/_ arquivos/res8.pdf, viewed 20 March 2012. When genetic resources are accessed in federal public protected areas (parks, wildlife reserves, etc.), the Union (federal state) must be a party to the benefitsharing contract. The same applies to public lands owned by states or municipalities (Brazil is a federal state). In other situations where the Union is not a party, it is entitled only to a share of the benefits. Benefits received by the Union (federal state) must be deposited in the National Environmental Fund, in the Naval Fund, or in the National Scientific and Technological Development Fund, and according to Provisional Act 2186-16/2001, they must be used for biodiversity conservation (Article 33). However, private landowners can use benefits for any purpose, and not necessarily for biodiversity conservation. Unlike plant genetic resources, however, only a very small number of local livestock breeds have been improved by breeding programmes. For details, see Chapter 17. By January 2013 Brazil had signed, but not ratified, the Nagoya Protocol. Some European countries, such as the Netherlands and Germany, are making germplasm of all PGRFA available under the terms and conditions of the multilateral system (Visser and Borring 2011). In recent years, the concept of livestock keepers’ rights has been advocated by NGOs, livestock keepers, pastoralist associations and scientists who support community-based conservation of local breeds. They formed the LIFE (Local Livestock for Empowerment of Rural People) Network. Köhler-Rollefson et al. (2010) explain that the term livestock keepers’ rights was first coined and promoted by civil society organizations during the World Food Summit held in 2002. The expression was an allusion to farmers’ rights, which had just been legally enshrined in the ITPGRFA. The Global Plan of Action for Animal Genetic Resources (GPA) is the first internationally agreed instrument for the conservation and use of animal genetic resources. It was adopted during the first International Technical Conference on Animal Genetic Resources for Food and Agriculture, held in Interlaken (Switzerland), from 3 to 7 September 2007. On the same occasion, the Interlaken Declaration on Animal Genetic Resources was also approved. Such instruments are very recent, and only a few countries have specific regulations on animal genetic resources and policies aimed at their conservation and sustainable use.

Genetic resources common pools in Brazil 123 17 The State of the world’s animal genetic resources is the first global assessment of livestock biodiversity, published by FAO in 2007 (FAO: 2007a). According to this report, a number of threats to animal genetic diversity can be identified, but the most significant is the marginalization of traditional production systems and associated local breeds, driven mainly by the rapid spread of intensive livestock production, often large-scale and utilizing a narrow range of breeds. 18 UNESCO’s Representative List of Intangible Cultural Heritage, http://www. unesco.org/culture/ich/index.php?lg=en&pg=00011, viewed 20 March 2012. 19 For more information on UNESCO’s project on ‘Safeguarding traditional foodways of two communities in Kenya’, see http://www.unesco.org/culture/ ich/index.php?project_id=00113, viewed 20 March 2012. 20 This Resolution can be seen at: http://www.datosperu.org/tb-normas-legalesoficiales-2010-Enero-04-01-2010-pagina-9.php, viewed 20 March 2012. 21 Source: UNESCO World Heritage Centre (2003) ‘Cultural landscapes: the challenges of conservation’ (World Heritage Paper no. 7), http://unesdoc. unesco.org/images/0013/001329/132988e.pdf, viewed 20 March 2012. 22 Administrative Order (Portaria) No. 127 of 30 April 2009, http://portal.iphan. gov.br/portal/baixaFcdAnexo.do?id=1756, viewed 20 March 2012. 23 According to the report The state of Brazil’s plant genetic resources for food and agriculture, there are 56 federal extractive reserves, predominantly in the Amazon, where species such as Brazil nuts (Bertholletia excelsa), rubber tree (Hevea brasiliensis), açaí (Euterpe oleracea and Euterpe precatoria), cupuaçu (Theobroma grandiflorum) and babaçu (Attalea speciosa) can be found. However, in the case of Cerrado (Brazilian savanna) species that are important for regional diets and extractive activities, such as pequi (Caryocar brasiliensis), cagaita (Eugenia dysenterica), baru (Dipteryx alata), buriti (Mauritia flexuosa), macaúba (Acrocomia aculeata) and mangaba (Hancornia speciosa), there are no protected areas specifically aimed at their in situ conservation. Extractive reserves belong to a category of protected area that allows traditional populations to live inside their limits (Santilli: 2010a). However, extractive reserves were not conceived for agrobiodiversity conservation and sustainable use, and some of the rules governing such reserves may be incompatible with traditional farming systems and agricultural practices.

Bibliography Andersen, R (2006) Realising farmers’ rights under the International Treaty on Plant Genetic Resources for Food and Agriculture, Report from the first phase of The Farmers’ Rights Project, Fridtjof Nansen Institute, Lysaker, http://www.fni.no/ doc&pdf/FNI-R1106.pdf, viewed 10 March 2011. Argumedo, A, Swiderska, K, Pimbert, M, Song, Y and Pant, R (2011) ‘Implementing farmers’ rights under the FAO International Treaty on PGRFA: the need for a broad approach based on biocultural heritage’, Paper prepared for the fourth session of the Governing Body of the International treaty of PGRFA, Bali, 14– 18 March, http://pubs.iied.org/G03077.html, viewed 22 March 2011. Biber-Klemm, S and Temmerman, M (2010a) ‘IPR regimes and animal genetic resources: situation and possible impacts’, Presentation at the International Technical Expert Workshop – Exploring the need for specific measures for access and benefit sharing of animal genetic resources for food and agriculture, Center for Genetic Resources, Wageningen, 8–10 December.

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Biber-Klemm, S and Temmerman, M (2010b) ‘Rights to animal genetic resources for food and agriculture – notes from an interdisciplinary workshop’, Working paper no. 2010/5 presenting the outcome of an international conference/workshop organized by the NCCR IP-91 on 27–28 November 2008, World Trade Institute, Berne, http://www.wti.org/fileadmin/user_ upload/nccr- t r ade.ch/w p3/R ight s%20to%20A nima l%20 G enet ic%20 Resources.pdf, viewed 10 September 2011. Bustamante, PG and Ferreira, FR (2011) ‘Accessibility and exchange of plant germplasm by Embrapa’, Crop Breeding and Applied Biotechnology, S1, 95–98. CGRFA (Commission on Genetic Resources for Food and Agriculture. FAO) (2007) The state of the world’s animal genetic resources, Rome, Italy, http://www.fao. org/docrep/010/a1250e/a1250e00.htm, viewed 20 February 2012. CGRFA (Commission on Genetic Resources for Food and Agriculture) (2010) The second report on the state of the world’s plant genetic resources for food and agriculture, Food and Agriculture Organization (FAO), Rome, http://www.fao.org/ docrep/013/i1500e/i1500e.pdf, viewed 20 February 2011. Clement, C, Rocha, SFR, Cole, DM and Vivan, JL (2007) ‘Conservação on-farm’, in Nass, L (ed.), Recursos genéticos vegetais, Embrapa Recursos Genéticos e Biotecnologia, Brasília, pp. 513–544. De Boef, WS (2000) ‘Tales of the unpredictable: learning about institutional frameworks that support farmer management of agro-biodiversity’, PhD thesis, Wageningen University, Wageningen. De Boef, WS, Sthapit, B, Upadhaya, MP and Shrestha, P (2007) ‘Estratégias de conservação em unidades de produção familiares’, in De Boef, WS, Thijssen, MH, Ogliari, JB and Sthapit, B (eds), Biodiversidade e agricultores: fortalecendo o manejo comunitário, L and PM, Porto Alegre. Embrapa (2009) The state of Brazil’s plant genetic resources. Second national report on conservation and sustainable utilization for food and agriculture, Brasília, DF. Embrapa (2011a) Plataforma Nacional de Recursos Genéticos, http://plataformarg. cenargen.embrapa.br, viewed 10 September 2011. Embrapa (2011b) Rede Nacional de Recursos Genéticos Animais, http://plataformarg. cenargen.embrapa.br/rede-animal, viewed 10 September 2011. Emperaire, L (2004) ‘O que é domesticação?’, in Almanaque Brasil Socioambiental: uma nova perspectiva para entender o país e melhorar nossa qualidade de vida, Instituto Socioambiental, São Paulo, pp. 338–339. Emperaire, L, Velthem, LHV and Oliveira, AG (2008) ‘Patrimônio cultural imaterial e sistema agrícola: o manejo da diversidade agrícola no médio Rio Negro (AM)’, Study presented at the 26th Meeting of the Brazilian Anthropology Association, Porto Seguro, Bahia, 1–4 June. Goedert, CO (2007) ‘Histórico e avanços em recursos genéticos no Brasil’, in Nass, L (ed.), Recursos genéticos vegetais, Embrapa Recursos Genéticos e Biotecnologia, Brasília, pp. 23–59. Hiemstra, SJ, Drucker, AG, Tvedt, MW, Louwaars, N, Oldenbroek, JK, Awgichew, K, Abegaz Kebede, S, Bhat, PN and da Silva Mariante, A (2006) Exchange, use and conservation of animal genetic resources: policy and regulatory options, Center for Genetic Resources, Wageningen. Instituto do Patrimônio Histórico e Artístico Nacional (IPHAN) (2007) Superintendência Regional de Santa Catarina, Roteiros Nacionais de Imigração,

Genetic resources common pools in Brazil 125 sob a supervisão e coordenação de Dalmo Vieira Filho e Maria Regina Weissheimer, Florianópolis, Santa Catarina, Brazil (unpublished). Ivanković, M (2008) Analysis of applicability of access and benefit sharing principles on animal genetic resources, Center for Genetic Resources, Wageningen, http:// documents.plant.wur.nl/cgn/literature/reports/reportIvankovic_ A BS_ AnGR_final2008.pdf, viewed 10 April 2011. Köhler-Rollefson, IU (2010) ‘Livestock keepers’ rights: a rights-based approach to invoking justice for pastoralists and biodiversity conserving livestock keepers’, Policy Matters, 17, 113–115, http://www.pastoralpeoples.org/docs/policymatters. pdf, viewed 10 April 2011. Köhler-Rollefson, IU, Mathias, E, Singh, H, Vivekanandan, P and Wanyama, J (2010) ‘Livestock keepers’ rights: the state of discussion’, Animal Genetic Resources, 47, 119–123. Leme Machado, PA (2003) Direito ambiental brasileiro, 11a edn, Malheiros Editores, São Paulo. Mariante, AS (2006) Animais do descobrimento: raças domésticas da história do Brasil, [Animals of the discovery: domestic breeds in the history of Brazil], EMBRAPA Recursos Genéticos e Biotecnologia, Brasília. Mariante, AS, MacNanus, C and Mendonça, JF (eds) (2003) Report on the state of animal genetic resources in Brazil, Embrapa, http://www.cenargen.embrapa.br/ publica/trabalhos/doc099.pdf, viewed 10 September 2011. Mariante, AS, Sampaio, MJA and Inglis, MCV (eds) (2009) The state of Brazil’s plant genetic resources, Second national report, Embrapa Technological Information, Brasília. Neves, E (2006) Arqueologia da Amazonia, Jorge Zahar, Rio de Janeiro. Phillips, A (2005) ‘Landscape as a meeting ground: category V protected landscapes/seascapes and world heritage cultural landscapes’, in Brown, J, Mitchell, N and Beresford, M (eds), The protected landscape approach: linking nature, culture and community, IUCN, Gland, Cambridge, pp. 19–35. Rössler, M (2005) ‘World heritage cultural landscapes: a global perspective’, in Brown, J, Mitchell, N and Beresford, M (eds), The protected landscape approach: linking nature, culture and community, IUCN, Gland, Cambridge, pp. 37–46. Santilli, J (2005) Socioambientalismo e novos direitos: proteção jurídica à diversidade biológica e cultural, Peirópolis, Instituto Socioambiental (ISA) and Instituto Internacional de Educação do Brasil (IIEB), São Paulo. Santilli, J (2010a) ‘Human-inhabited protected areas and the law: integration of local communities and protected areas in Brazilian law’, Journal of Sustainable Forestry, 29 (2–4), 390–402. Santilli, J (2010b) Agrobiodiversidade e direitos dos agricultores, Peirópolis, São Paulo. Santilli, J (2012) Agrobiodiversity and the law: regulating genetic resources, food security and cultural diversity, Earthscan, London. Sauer, C (1986) ‘As plantas cultivadas na América do Sul tropical’, in Ribeiro, B (ed.), Suma etnológica brasileira: etnobiologia, 3rd edn, Vozes/FINEP, Petrópolis, pp. 59–90. Singh, A and Varaprasad, KS (2008) ‘Criteria for identification and assessment of agro-biodivesity heritage sites: evolving sustainable agriculture’, Current Science, 94 (9), 1131–1138, http://cs-test.ias.ac.in/cs/Downloads/article_id_094_09_ 1131_1138_0.pdf , viewed 20 January 2011.

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Tvedt, MW, Hiemstra, SJ, Drucker, AG, Louwaars, N and Oldenbroek, K (2007) Legal aspects of exchange, use and conservation of farm animal genetic resources, Report no. 1, Fridtjof Nansen Institute, Lysaker, http://www.fni.no/doc&pdf/ fni-r0107.pdf, viewed 10 April 2011. Visser, B and Borring, J (2011) ‘The European Regional Group: Europe’s role and positions during the negotiations and early implementation of the International Treaty’, in Frison, C, López, F and Esquinas-Alcázar, JT (eds) Plant genetic resources and food security: stakeholder perspectives on the International Treaty on Plant Genetic Resources for Food and Agriculture, Earthscan, London.

7

Developing a common pools strategy for genetic resources for food and agriculture A case study of Malaysia Gurdial Singh Nijar

Introduction This chapter looks at the way in which Malaysia seeks to deal with its plant genetic resources for food and agriculture (PGRFA). These resources are central to securing food security, especially in developing countries. This issue has assumed considerable importance because Malaysia is in the process of drafting a law regulating access to genetic resources and the sharing of benefits arising from their utilization (access and benefit sharing (ABS law)). At the same time, as a party to the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA) since 2003, it is grappling with the complex question of implementing the mandatory provisions of the multilateral system of facilitated access and benefit sharing to crops listed in an annex to the Treaty. Further, Malaysia is a member of the regional Association of South-East Asian Nations (ASEAN) political grouping which is seeking to put a regional agreement on ABS of genetic resources in place.1 In the meantime, Malaysia participates actively in several collaborative, regional and international initiatives that seek to share particular genetic resources. The central question addressed by this chapter is whether these various and seemingly disparate activities in relation to ABS or PGRFA promote or hinder the free use and exchange of these resources. A subsidiary question is how to develop coherence between these initiatives so as to provide a common pool of resources for food and agriculture at the regional level. The underlying assumption is that unimpeded use and exchange of such resources among farmers and other traditional breeders and, as a subset, the ability to exchange these resources among themselves freely is crucial for food security. It is on the basis of such exchange over millennia – involving sustained and continuous processes of selection – that crops and farm livestock were domesticated and improved. Successive generations of farmers and breeders have continued with this process to eliminate or reduce unfavourable traits, and to overcome specific environmental and biological conditions that hinder agricultural production, such as droughts or pest outbreaks. This underscores the need

128 Gurdial Singh Nijar for continuous exchange in the face of ever changing consumer demands and production conditions. The need to keep the developed resource stable also requires management. For this too, the free flow of genetic resources among farming and agriculture-based communities was and is critical. This is especially of crucial importance in the case of PGRFA, where there is a high level of interdependence of countries and farming communities in the use and development of genetic resources. Indeed, no country is considered completely self-sufficient (Nijar et al. 2011). One possible model for managing this interdependence may be by developing national, regional or international systems of exchange which ensure facilitated access to GRFA that also ensures the sharing of benefits with the nurturers of these resources: farmers, pastoralists, breeders, consumers and society as a whole (Tansey 2008).

The national ABS approach Malaysia has been engaged in drafting an ABS law since shortly after it ratified the Convention on Biological Diversity (CBD). At the time of writing, the completed draft is in the midst of stakeholder consultations as a prelude to its presentation to Parliament for adoption as an Act, which is expected to be in 2013. The draft law adopts substantially, and expands upon, the ABS provisions in the CBD. Thus, access will be granted through bilaterally negotiated contracts on the basis of mutually agreed terms (MAT) and prior informed consent of the provider.2 To what extent does the draft law take into account the distinctive features of GRFA and provide for facilitated access? The scope of the law covers all biological resources, wherever found or grown for commercial utilization or for research and development, and extends to derivatives comprising or contained in these resources. This implies that there is no special consideration for GRFA. Access to GRFA, in common with other genetic biological resources, would have to go through the application process for a permit from the competent authority. The conditions for the grant will have to be satisfied. And the grant of the permit will be based upon terms and conditions including those contractually negotiated. These are impediments to the free use and exchange of GRFA. There are, however, several provisions that provide an opening for the exclusion of GRFA from the scope and for the establishment of a different legal regime that could take into account the distinctive features of GRFA, in particular the need to promote facilitated access. The Minister is empowered to make the exclusion in specified circumstances. Ensuring food security could be one such circumstance. Another situation could envisage other resources for which there are existing regional and international arrangements. The draft law presently provides explicitly for the preservation of existing arrangements with regard to other resources.

A common pools strategy for GRFA in Malaysia 129 Malaysia, for example, is a party to the International Treaty on Plant Genetic Resources for Food and Agriculture which makes it mandatory to provide free access to specified crops (discussed in the following section). It is also a member of international exchanges for cocoa, pepper and palmoil. These regional and international arrangements allow for free access to germplasm for research and development and the sharing of research results. The provision could also help preserve the integrity and continuance of several formal collaborative regional and international arrangements: see section 4 with similar objectives. In essence these arrangements allow for the preservation and development of common pools in respect of the specified resources. Yet another provision in the draft law that relaxes the rules relating to access permits is where resources are accessed for non-commercial research. Those undertaking ‘pure academic and non-profit orientated’ research can apply for an exemption from the requirement to obtain a permit. Then the researcher is exempted from the rest of the provisions relating to access, such as negotiating a contract. He or she needs to sign a statutory declaration of the intent and undertake to comply with the terms for normal commercial access if there is a change of intent. Breach of the statutory declaration is punishable with imprisonment. The taking of biological resources by indigenous and local communities for purposes other than commercial utilization or R&D is also exempted from the access provisions, as are the traditional and customary use and exchange of the resources among such communities. This supports the time-honoured traditional role and efforts of indigenous and local farming communities in enriching local genetic resources, which in turn enhances the national crop genepools. These provisions imply that a pool of resources can be granted access outside of the national ABS law. The access can be freed of the bureaucratic strictures and requirements. Implementing this may require the enactment of supplementary regulations under the draft law to provide for the terms and conditions governing the free access, use and exchange of the resources. The regulations could either provide for model clauses for such access or require the use of a standard material transfer agreement that establishes the access and benefit-sharing terms, modelled on the standard material transfer agreement under the International Treaty on Plant Genetic Resources for Food and Agriculture. The conditions for the establishment of such a common pool need to be stated explicitly. If such conditions are fulfilled, the Minister is obliged to exempt the resources comprising the pool from the reach of the ABS requirements. A suggested overarching requirement could be that the resource(s) must be such that free use and exchange is necessary to engender their conservation and sustainable development that is considered:

130 • • • •

Gurdial Singh Nijar vital to the country’s food security needs; necessary to promote use by traditional farmers; important to alleviate poverty among communities; needed to address specific environmental and biological problems.

Yet another provision could exempt resources/pools that are the subject of existing national, regional or international collaborative arrangements that promote exchange for research into crops of vital national interest, either for conservation or multi-location variety trials or to address the facets listed above. Alternatively, the resources or their use in specific circumstances could simply be exempted from the applicability of the access and benefit-sharing law.

Implementing the ITPGRFA Malaysia is a party to the International Treaty on Plant Genetic Resources for Food and Agriculture (the Treaty). It acceded to the Treaty on 5 May 2003. The Treaty establishes a multilateral system (MLS) of facilitated access and benefit sharing for those plant genetic resources that are most important for food security and on which countries are most interdependent.3 These are listed in Annex 1 to the Treaty. The crops from this list that Malaysia holds are: • • • • • • • • •

rice; sweet potato; cassava; coconut; eggplant; banana; citrus; breadfruit; and vegetable crops, which include cabbage, chilli, pepper, radish and turnip.

As a contracting party, Malaysia assumed obligations, the most fundamental of which is that it has agreed to facilitate access on a multilateral basis to these listed crops over which it has management and control and that are in the public domain.4 It has also agreed that facilitated access shall be provided pursuant to a Standard Material Transfer Agreement (SMTA). This is a standardized contract that establishes the terms for the transfer. This eschews the need for negotiating bilateral contracts for each access and transfer. The standard terms and conditions include the sharing of benefits derived from the commercial use of plant genetic resources for food and agriculture (PGRFA). In addition, as a contracting party, Malaysia has agreed to share

A common pools strategy for GRFA in Malaysia 131 a range of other benefits, including information, capacity building and transfer of technology. Malaysia has a dualist form of constitutional governance. Treaties are not self-executing. The ratification of a treaty alone does not make its provisions applicable domestically, unlike a monist system. Treaties will have to be brought into the national legal architecture by legislative means. This means either expressly enacting the provisions of the treaty into a law; or impliedly, requiring domestic laws to be read or interpreted in accordance with the treaty. In the latter case, the treaty’s provisions are directly incorporated into the existing practices of administrative bodies in the implementation of an existing law. An administrative instruction would suffice to do so. Yet another mode of incorporating the provisions of a treaty into national law is when a court interprets the effect of a treaty when adjudicating a case. The apex High Court of Australia held that parties to a treaty intended to give effect prima facie to the country’s obligations under international law. The action of a government department was declared bad as it had not taken into account the provisions of the treaty in its decision-making process – a legitimate expectation created by the government signing the treaty.5 In the UK, the highest court has ruled that citizens had the right to expect the government to act domestically in accordance with the treaty it had entered into.6 The Supreme Court of India has also ruled that international conventions and norms must be read into Constitutional provisions in the absence of enacted law when there was no inconsistency between them.7 These approaches support the incorporation of the terms of a treaty through administrative orders and are especially amenable to assimilating specific provisions of a treaty into existing administrative structures. This avoids the time-consuming and difficult process inherent in law making. This would require promulgating a stand-alone law to replicate the provisions of the ITPGRFA or enacting regulations under the ABS law. The latter approach would involve an administrative instruction directing those bodies holding the covered crops to operationalize the multilateral system of exchange under the Treaty. The latter approach is preferred. Under the terms of the Treaty, the covered materials are automatically part of the multilateral system. This is based on a cumulative interpretation of Articles 10.2 and 11.2 of the Treaty. The former states clearly that parties, in the exercise of their sovereign rights, agree to facilitate access and share benefits through a multilateral system for which they have given their prior informed consent. The latter stipulates what crops are automatically agreed to be covered by this arrangement. Hence there is no need for any declaration or notification to activate the arrangement. Yet there is a need to implement the system nationally by formally bringing the listed crops into the system so that other contracting parties are informed as to the materials available, their actual use, and where and how they may be accessed. This information needs to be transmitted through the Treaty secretary and could be supplied electronically. In other words,

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once the Treaty becomes part of the legal and/or administrative rubric of the country, there is still a need to operationalize the obligations – through effective facilitative implementing measures. This would also involve setting up the necessary supportive infrastructure and mechanisms. The crops that fall within the MLS must be under the management and control of the government of Malaysia and be in the public domain, that is, free from intellectual property rights (IPRs) (Moore and Tymowski 2005: 84). ‘Management and control’ denotes both a factual as well as a legal situation. ‘Under management’ means the ‘capacity to determine how the material is handled’ and not the legal rights to dispose of the PGRFA. ‘Control’ refers to that legal power to dispose of the material (IT/AC-SMTAMLS 1/10/Report: 10). Taken together, the term refers to the government of a contracting party managing the resource such as through conservation in a genebank. In addition, and crucially, it must have the power to decide on the treatment to be given to such resources. The factual requirement is met if the collection is actually managed and controlled by the government. Conversely, if a separate entity holds the collection over which the government has no control, then the requirement is not met. The position may not be as simple as it is presented. First, governmental functions in Malaysia, as in many other countries, are conducted through a variety of forms and means. Bodies such as corporations or legal entities may be set up to carry out these functions.8 These bodies are given a large measure of autonomy to promote efficient functioning. This includes the power to handle as well as dispose of the materials. Second, in a federal constitutional structure, jurisdiction over specific subject matters is split between the federal and state (referred to sometimes as provincial) authorities. Each of these situations has implications for the MLS under the Treaty. These are discussed in turn.9 The largest accessions of Annex 1 crops are held by a research institution – the Malaysian Agricultural Research and Development Institute (MARDI) – a body set up by an act of Parliament. It holds 22,751 accessions with 869 species in both its seed and field genebanks. The seed genebanks mainly conserve rice and vegetables, totalling 19,108 accessions, with approximately 14,000 accessions for rice (Shukor interview, 2010). Hence, rice is the main crop that is conserved by its seed genebanks with vegetables as the remaining material. The field genebanks (3643 accessions), covering 157.75 hectares, include fruits, herbs, medicinal plants, traditional vegetables, biopesticide plants and aromatic plants (MARDI communication 2011). Are MARDI’S accessions in the management and control of Malaysia as a contracting party? As MARDI holds the largest accessions in Malaysia, it is of first importance to ascertain whether its accessions fall within the management and control of the federal government. This requires an analysis of its status.

A common pools strategy for GRFA in Malaysia 133 Generally, the Malaysian government conducts its functions in a variety of ways, including through the establishment of bodies through an act of Parliament. The statute creating the body will thus determine its status visà-vis the government. MARDI is a research institute set up by an act of Parliament – the Malaysian Agricultural Research Institute Act 1969 (Act 11) – and came into operation throughout Malaysia on 2 May 1969. It thus acquired the status of a statutory body. The key question to determine, in the context of the collections of PGRFA held by MARDI, is whether the government has the power to decide what treatment should be given to those resources, and the legal power to grant access to, or dispose of, those materials. The test is: does the government have the right not only to direct the general management of MARDI but also the power to direct how any specific function of MARDI should be carried out, if it so chooses? In other words does MARDI function like a government department? There are judicial precedents that provide an answer to this question. In the English cases, Trendtex Trading Corporation v Central Bank of Nigeria10 and Mellenger v New Brunswick Development Corporation11 – both of which have been approved by the courts of Malaysia – the Court of Appeal said that all the evidence to see whether the organization was under government control and exercised governmental functions must be considered. Both the factual as well as the legal situation must be examined. This requires an examination of the provisions of the MARDI Act as well as the factual situation relating to decision-making in the carrying out of its functions. The autonomous facet of MARDI is seen in the fact that its board – which effectively runs the institute – is given the status of a body corporate, with perpetual succession and a common seal and may sue and be sued in its own name. Additionally, the board decides whether or not to allow any access to research findings and facilities of MARDI. ‘Facilities’ include database and germplasm collection. The board can impose such conditions, restrictions and limitations as it may determine for the grant of this access (Section 23A). This provision was added by way of an amendment (Act A1160) which came into force on 1 November 2002. The property in every research finding or every programme undertaken by MARDI vests in the board if the research is funded entirely by public funds or, by the board jointly with that body, if funded by a private body (Section 23). However, these provisions are not conclusive of the status of MARDI. The cumulative effect of other provisions makes it clear that, while the board is given a high degree of autonomy, key functions are to be undertaken by, or with the approval of or concurrence of the Minister of Agriculture, and sometimes also the Minister of Finance. This includes final decisions as to policy and other matters that are not inconsistent with

134 Gurdial Singh Nijar the provisions of the Act, appointment of the highest echelons of the board (director general and deputy director generals), budget, carrying out commercial research and borrowing money. More particularly as regards PGRFA, the Minister of Agriculture is empowered to determine policies regarding the collections and direct the board as to the conditions for any grant of access. Whether the Minister does so is a matter for factual determination. The board invariably follows any directions given by the Secretary General – ostensibly emanating from the Minister/Ministry. This implies that there is direct control over the collections by the Minister/Ministry (Communication from consultation with MARDI, January 2011). Finally, the Statutory Bodies (Accounts and Annual Reports) Act of 1980 applies to the board (Section 15). This requires the MARDI board to submit its audited statement of accounts and the Auditor General’s report together with a report of its activities to the Minister. The Minister is obliged to table these in each House of Parliament (Sections 7 and 8 of the 1980 Act). The English Court of Appeal decision referred to earlier – Mellenger v New Brunswick Development Corporation – is instructive, especially since it has been cited with approval by the Malaysian court. In Mellenger, the issue was whether a statutory corporation could be identified with being a part and parcel of the government – like a government department. Although the corporation was a body corporate, the Court held that the other clauses showed the close connection of the corporation with the government. These clauses included the fact that the Minister was an ex-officio director, and the other directors were appointed by the government. There was no issued capital. It had no stocks or shares. Its principal powers were for a public purpose. Although it had the right to carry out ordinary trade or commerce, it never in fact did so. It promoted industrial development of the province in much the same way as a government department. The Court concluded that the corporation ‘…is really a part and parcel of the government’.12 The test in this case was adopted by Malaysia’s High Court in Tan Suan Choo v Majlis Perbandaran Pulau Pinang.13 This case has been cited with approval by Malaysia’s highest courts. The connection between MARDI as a public body performing like a government department seems to be even stronger than in the Mellenger case. It is difficult to avoid the conclusion that MARDI is under the management and control of the government of Malaysia. The upshot is that its accessions that are Annex 1 PGRFA are automatically included under the MLS of the Treaty, if the other provisions of the Treaty are met.14 The further conclusion is that any listed Annex 1 accessions of other bodies governed by similar statutory provisions will also be included in the MLS of the Treaty.

A common pools strategy for GRFA in Malaysia 135 Are the accessions in public universities in the management and control of Malaysia as a contracting party? Other annex 1 crops are held by public universities. Are their collections subject to the MLS of the Treaty? This issue is examined by an analysis of the legal structure of the set-up of the universities and the centres holding the collections. There are several public universities in Malaysia, namely: Universiti Kebangsaan Malaysia (UKM), Universiti Pertanian Malaysia (UPM), Universiti Sains Malaysia (USM), Sabah Universiti, Majlis Amanah Rakyat (MARA) University, and the University of Malaya (UM). They also hold accessions that include Annex 1 crops, as table 7.1 shows. Public universities are also set up by an act of Parliament. As in the case of MARDI, they are also then statutory bodies. What then is the status of these collections? Are universities also under governmental control and management? If so, then their collections would also fall under the MLS of the Treaty. An analysis of the statute of one public university, the University of Malaya (UM),15 shows that despite its ostensibly autonomous character it is a corporate body, with perpetual succession and a common seal and may sue and be sued in its own name; other provisions suggest that public universities are under the management and control of the government. The government directs its activities, appoints and decides upon the duration of the appointment of all top management, provides funding, requires accountability of expenditure, determines policies and makes decisions as regards the administration, including any that may have financial implications. Table 7.1 Annex crops held by public universities University

Total collection

Annex 1 crops

Herbarium UM

63,000

Citrus, banana

Herbarium UKM

50,000

Citrus

Herbarium UMS

6,500

Tapioca varieties (manihot esculenta crantz)

Herbarium UNIMAS

Unknown

Herbarium, UPM (Biology Department)

40,000

Herbarium USM

20,000

MARA University of Technology, Sabah Campus

Taro, sweet potato

Cassava (manihot esculenta crantz)

Sources include http://www.globinmed.com, viewed 13 March 2011, and the FAO Country report 2007 (FAO 2007)

136 Gurdial Singh Nijar However, as regards the furtherance of academic pursuits and matters related thereto, the university administration is given a large measure of autonomy. For example, an institute may be established by the university in consultation with the Studies Committee. This committee is appointed by the Senate. The Senate is the academic body of the university and has control of matters related to academia, such as research. Specific collections centres – such as the herbarium set up by UM – function under this academic rubric. This centre, arguably, is not carrying out the functions of government. This is reinforced by the fact that the university and/or the herbarium make their own decisions with regard to the disposal of the collections. It is set up under the general powers conferred by the University Constitution. The Rimba herbarium has Malaysia’s largest university collection, with 63,000 accessions. There are several main show collections, including medicinal plants, palms, and the Treaty’s Annex 1 citrus and citroid collection. The citrus and citroid collection is reputed to be the most comprehensive in Malaysia. The wild citrus relatives are important because of potential use in breeding for fruit improvement and hardiness. Some have value as root stock for citrus growing, including on marginal soils. Most species have potentially useful and distinctive essential oils in their tissues. The collection is generally accessible to the public. There is also a small research collection of banana, another Annex 1 crop. The upshot is that Annex 1 PGRFA collections held by institutes or centres of the university may not be subject to the MLS of the Treaty. Establishing criteria for determining ‘management and control’ of a contracting party The Treaty makes clear that all Annex 1 PGRFA are included within the MLS if they are: 1 2 3

found in the country, whether in situ or ex situ; under the management and control of the federal government or its agencies, institutes or other bodies; and in the public domain, that is, not subject to any intellectual property rights (Moore and Tymowski 2005: 84; Correa 2010).

Ascertaining what constitutes ‘management and control’ may not be entirely free from difficulty in any given case, as the earlier discussion shows. Hence the importance of establishing criteria for determining whether or not a body or entity is in the ‘management and control’ of the government within the meaning of the Treaty. As to existing bodies, it may make for legal certainty if it is explicitly declared which of these bodies come within the purview of the Treaty. For other bodies or institutions, and for the sake of transparency, domestic law could

A common pools strategy for GRFA in Malaysia 137 establish criteria for such determination. Such criteria may include the following factors that relate to the degree of management and control: appointment of key decision-makers, decision-making powers, giving of directions, reporting requirements, supply of funds, disbursement of funds and expenditure, and accountability of expenditure. In the context of Annex 1 PGRFA, a useful specific criterion would be the right to direct the disposal of the PGRFA collections. The cumulative effect of these criteria must be considered in determining whether or not the collections are within the MLS. The state collections State authorities also hold a substantial number of Annex 1 collections. The collection centres and the responsible authority designated by the state include Herbarium SFD; Sarawak Herbarium Forest Research Centre, SFD; Herbarium Sarawak Museum; Herbarium SBC; Herbarium National Centre for Plant Pest Collection and Depository; Herbarium Penang Botanic Garden; and Herbarium Sabah Park.16 The Malaysian Federal Constitution distributes powers in respect of specified subject matter between the federal and state authorities. Land is within the exclusive jurisdiction of the state authorities. The Constitution includes within land all matters relating to agriculture and forestry. Genetic resources are conceived in Malaysia as being part of the jurisdiction relating to land. In a landmark case in Malaysia, it was decided that matters relating to land fell within the exclusive jurisdiction of a state under the Federal Constitution.17 It is in exercise of this exclusive constitutional jurisdiction that the states of Sabah and Sarawak have enacted their own biodiversity laws which also deal with ABS in relation to their genetic resources. Both these states harbour PGRFA. Sabah has a large collection of genetic resources, held by the Sabah Park, Mount Kinabalu Botanical Gardens as well as by the herbarium at Sabah Forestry Department. Sarawak also has holdings although of considerably fewer accessions. The collections are set up as a public state entity but are nonetheless outside the direct control of the federal government and therefore outside the purview of the MLS of the Treaty. In this case, the consent of the entity is required before the MLS can apply to the PGRFA held by any natural and legal persons within their jurisdiction (Article 11.3 of the Treaty). Such persons include state bodies. It is instructive that the state of Sabah has proposed the following provision in its Sabah Biodiversity (Access and Benefit Sharing) Regulations 2011. It reads as follows: Nothing in these Regulations shall affect, vary, nullify or render invalid any provisions relating to the obligations established by the

138 Gurdial Singh Nijar ITPGRFA in respect of access to and the transfer of plant genetic resources for food and agriculture of the crops covered by the Treaty. Any such access and transfer shall be in accordance with the conditions set out in Part IV of the said Treaty. This provision is designed to include the PGRFA covered by the Treaty and for its purpose under the Treaty. The access and transfer of such resources is to be in accordance with the conditions set out in Part IV of the Treaty. This implies that all Treaty PGRFA are excluded from the ABS provisions of the regulation and placed under the MLS of the Treaty. This marks a significant advance in non-contracting parties (state governments) who are holders of Treaty materials placing their materials in the MLS, thereby extending its coverage as envisaged under Article 11.2. Sarawak’s biodiversity law and regulations do not make any reference to the Treaty. The rest of the states do not have any law dealing with ABS of genetic resources. However, all the state governments are expected to sign on to the proposed draft national ABS law referred to earlier. This proposed law – in deference to the constitutional distribution of power – preserves the autonomy of states by granting them full rights to determine access and benefit sharing in respect of their genetic resources. However, the provisions of the federal law take effect for those states that adopt the law. One such provision empowers the Minister to exclude genetic resources from the scope of the national ABS law where such access is under the purview of ‘any international treaty to which Malaysia is a party’. This is intended to exclude those resources that come within the MLS system of the Treaty. An acceptance by all the states in the federation of this law, as is expected, implies their support for the applicability of the MLS of the Treaty to resources that are also located within their respective jurisdiction. Any state law or policy will then have to explicitly provide for this. This is a significant milestone for Malaysia in achieving the fullest possible coverage of the MLS as exhorted by Article 11.2 of the Treaty. Facilitating participation in MLS Although materials that fall within the ambit of the Treaty are automatically part of MLS without the need for any declaration or notification, there is, nonetheless, a need for others to know what materials exist and where these can be accessed. This would require documenting the PGRFA within the system. Such information should be adequately documented and made publicly known and accessible. This information could be provided on a website and contain detailed data on the composition of the collection and user procedures in order that samples are readily available.

A common pools strategy for GRFA in Malaysia 139 The information must be notified to the secretariat of the Treaty, which in turn makes the information available on its website. This will be the task of the focal agency in Malaysia – the Department of Agriculture (DOA). At the time of writing (2013), it has delegated this responsibility to MARDI. MARDI has developed a few information systems to maintain PGRFA. From 2007, MARDI coordinated the establishment of an information system for PGRFA on certain crops including rice, aromatic plant species, indigenous vegetables, capsicum, eggplant and tomato, and certain ulam (salad-like) species in MARDI. The system being actively used for PGRFA and/or seed stock data management of relevance are the Rice Genebank Information System (RGBIS) and the Agrobiodiversity Information System. These provide information on the genetic resources (GR) collected, characterized and conserved in the respective genebank (FAO 2007). Ultimately, this national system should feed into a global information system contemplated by Article 17 of the Treaty. It bears reiteration that access to PGRFA found in in situ conditions are subject to the same provisions as those provided ex situ. They will be provided according to national law; in the absence of such law, they will be provided according to standards set by the governing body of the Treaty under Article 12.3(h). Such law cannot undermine the provisions of the Treaty and would relate in the main to the mechanics of implementation, that is, the specific modalities for access to materials located in national parks and other protected or vulnerable areas and with procedures for collections of plants. Malaysia’s proposed national ABS law will hence have to provide facilitated access to in situ plant materials for food and agriculture under its management and control and in the public domain and for the purposes set out in the Treaty – that is, for utilization and conservation for research, breeding and training for food and agriculture. This has to be in accordance with the terms of the Treaty. This means that these materials cannot be made subject to the ABS procedures as applicable for material that is not in the MLS. Hence the ABS law needs to exclude altogether the PGRFA covered by the Treaty for the purpose stated therein, namely, the utilization and conservation for research, breeding, and training for food and agriculture. The same resource, if used for any other purpose, would be subject to the ABS law. The purposes expressly excluded from the Treaty include chemical, pharmaceutical and/or other non-food/feed industrial uses (Article 12.3(a)). Further, if the resource is in places such as protected areas or national parks managed by other authorities outside the agricultural sector, then there may be a need for adequate coordination between the agricultural ministry and relevant authorities. The objective is to remove impediments to facilitated access. Finally, organizations holding PGRFA that are not automatically included in the MLS – such as state governments that do not adopt the

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national ABS law, public but non-governmental entities, private holdings and IPR holders – should be encouraged to place their collections in the MLS, as the Treaty requires. This is important, as otherwise a future decision of the governing body of the Treaty could well decide to disallow facilitated access to the MLS by those holders that have not included their holdings in the MLS.18 The measures to be taken are left to the discretion of contracting parties. These may include: • • • •

financial or fiscal incentives to holders – e.g. eligibility for public funding schemes; policy and legal measures; administrative actions setting up domestic procedures for inclusions; or awareness raising efforts (especially at the level of farmers).

If the states agree to adopt the national ABS law, then, as earlier discussed, this could result in all states acceding to their collections being placed under the MLS of the Treaty. The rest of the private accessions are relatively small compared to those of the states and would not impair the facilitation of access to PGRFA.

International plant genetic resources networks Before the Treaty came into force, there were already several existing international networks of plant genetic resources. Some were crop based, others region based and yet others were thematic networks. These served as important platforms for exchange, information sharing, technology transfer, research collaboration and for sharing responsibilities for activities such as collecting, conservation, distribution, evaluation and genetic enhancement. Such networks link those involved in the conservation, management, development and utilization of PGRFA, and thus promote the exchange of materials on the basis of MAT and enhance the utilization of germplasm (Moore and Tymowski 2005: 129). The Treaty recognizes the need to build upon existing networks rather than trying to build up a whole new set of networks. Hence Article 16.1 encourages these networks with a view to achieving the most complete coverage possible. Among the steps recommended in order to strengthen networks and their role in the implementation of the Treaty is the development of synergies between different networks as well as countries comprised in the networks. This section explores the practical working of one such network. Examples of common pools As noted earlier, there are several international arrangements that provide for exchange of germplasm and sharing of information, and subscribed to by developing countries in the Asian region. These include the following:

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•

•

•

Asian Network for Sweet-Potato Genetic Resources (ANSWER): conservation of sweet-potato genetic resources (e.g. ex situ, in vitro, cryopreservation and others). ANSWER has also initiated capacity building among member countries with regard to maintenance, characterization, evaluation and documentation of their respective sweet-potato genetic resources. It also aims to establish an efficient means of exchanging information. It is supported by the International Potato Center (CIP) and the International Plant Genetic Resources Institute (IPGRI), now Bioversity International. (Members from ASEAN: Cambodia, Indonesia, Malaysia, Philippines, Thailand, Vietnam; from Asia: India, Japan, South Korea, Sri Lanka.) International Maize and Wheat Improvement Center (CIMMYT): exchange of germplasm and sharing of information of maize. (Members from ASEAN: Malaysia; from Asia: India, Nepal, China, Iran, Japan.) International Coconut Genetic Resources Network (COGENT): a regional network in Southeast Asia (of which more later). Promotes sustainable coconut production through the exchange of germplasm and sharing information. (Members from ASEAN: Indonesia, Malaysia, Philippines, Thailand, Vietnam; from Asia: Bangladesh, China, India, Sri Lanka.) The Banana Asia Pacific Network (BAPNET): enhances regional collaboration activities in the following areas: germplasm management, information development and exchange, banana resource development, and strategic planning. It operates under the former INIBAP (see the following bullet point). (Members from ASEAN: Indonesia, Philippines, Vietnam, Malaysia, Thailand; from Asia: Taiwan, Bangladesh, China, India, Sri Lanka; from the Pacific: Fiji, Papua New Guinea.) Banana and Plantain Section of Bioversity International: formerly the International Network for the Improvement of Banana and Plantain (INIBAP)19 for the assessment of tissue culture-derived banana and exchange of germplasm, sharing information and capacity building. Asian Vegetable R&D Center (AVRDC): exchange of germplasm, sharing information and capacity building in relation to vegetables/pulses. Maintains the world’s largest public vegetable genebank with more than 56,000 accessions from 150 countries, including more than 44,000 accessions of globally important vegetables and close to 12,000 accessions of indigenous vegetables. International Group for Genetic Improvement of Cocoa (INGENIC): established the international cocoa germplasm database. Exchange of germplasm and testing of advanced lines. (Members from ASEAN: Indonesia, Malaysia, Philippines, Vietnam; from South Asia: India, Sri Lanka.) International Pepper Community: exchange of germplasm, sharing information and testing of advanced lines.

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•

• •

(Members from ASEAN: Indonesia, Malaysia, Vietnam; from Asia: India, Sri Lanka; associate member: Hainan Province.) International Rice Research Institute (IRRI): exchange of germplasm, testing advanced lines, information sharing and capacity building. (Members from ASEAN: Cambodia, Indonesia, Lao PDR, Myanmar, Thailand, Vietnam; from Asia: Bangladesh, China, India, Nepal, South Korea, Sri Lanka.) International Network for Genetic Evaluation of Rice (INGER): global model for the exchange, evaluation, release and use of genetic resources under the ITPGRFA, using the SMTA to facilitate access and benefit sharing. (Collaborators from ASEAN: Cambodia, Indonesia, Lao PDR, Malaysia, Myanmar, Philippines; from Asia: Afghanistan, Bangladesh, Bhutan, China, India, Iran, Iraq, Japan, Korea DPR, South Korea, Nepal, Pakistan.) International Center for Tropical Agriculture (CIAT): exchange of cassava germplasm and sharing of information. Taro Network for Southeast Asia and Oceania (TANSAO): provides for the exchange of germplasm and sharing information.20

Other collaborative efforts include the following: •

•

•

Agricultural Technical Cooperation Working Group of Asia Pacific Economic Cooperation (APEC): plans and implements information and knowledge exchange, workshops, training, safe exchange of genetic resources, and harmonization of policies on PGR and IPR among member economies. Consultative Group on International Agricultural Research (CGIAR): promotes on-farm studies of adapatability of food crop varieties (zucchini and potatoes); provides for the exchange of germplasm. Users’ Perspectives with Agricultural Research and Development (UPWARD): part of the International Potato Center (CIP), collaborates with the national programme to conduct field research projects, co-organizes training and workshops, and supports publishing and information sharing activities. Its work also includes the exchange of germplasm, sharing information, testing of advanced lines and capacity building.

International Coconut Genetic Resources Network (COGENT) An international coconut genetic resources network was established at an international workshop in Cipanas, Indonesia, in October 1991. This was on the recommendation of the Consultative Group on International Agricultural Research (CGIAR), its Technical Advisory Committee and representatives of 15 coconut-producing countries. In 1992, Bioversity International (Bioversity), with the endorsement of CGIAR and its donors,

A common pools strategy for GRFA in Malaysia 143 established the International Coconut Genetic Resources Network (COGENT). It is an international collaborative programme to promote sustainable coconut production through the exchange of germplasm and sharing information. Its ASEAN members comprise Indonesia, Malaysia, Myanmar, the Philippines, Thailand, Vietnam; members from Asia are Bangladesh, China, India, Pakistan and Sri Lanka.21 COGENT maintains a Coconut Genetic Resources Database (CGRD), wherein data about coconut cultivars appear in two main parts: passport data and priority characterization, and evaluation data. The data in the CGRD contain passport and characterization data of 1,316 accessions conserved in 25 sites in 18 countries. Its objective is to facilitate data storage and exchange among the members of the COGENT network. This enables coconut breeders to access data on coconut cultivars.22 Countries that are members of COGENT make a commitment to support national coconut research activities and undertake the study of the diversity of coconut germplasm in the country, and conserve, protect and maintain the diversity. In relation to common pools, they make a commitment to exchange and/or provide information on coconut genetic resources held in the country, particularly information on diseases of unknown etiology or pest recurrences and, importantly, to provide access to its germplasm and participate in the mutual exchange of coconut germplasm either for conservation or multi-location variety trials subject to mutual agreement with other member countries and with COGENT and Bioversity. Thus, members gain access to the germplasm information from other members housed in the database and use that as a basis to identify germplasm from a wide genetic base for breeding work. But they also gain access to coconut germplasm, subject to mutual agreement and the ability to move material safely, as well as access to new technologies. COGENT has identified several problems and immediate concerns which threaten the viability of the network. Of particular concern for common pools are problems relating to the collection of additional passport and characterization data to enhance the usefulness of the international coconut genetic resources database (CGRD) and developing databases of farmers’ varieties and multipurpose uses of coconut. There are also problems of collecting, conserving, evaluating and enhancing coconut germplasm of national agricultural researches of member countries and International Coconut Genebanks (ICGs) and conducting research to facilitate safe germplasm exchange, such as pest risk assessment, pathogenicity testing, pathogen detection and indexing, refinement of embryo culture technique and coconut physiology. Also of importance are the problems of developing and updating guidelines on coconut breeding research techniques and coconut collecting and conservation strategies; conducting multi-location trials within and among coconut-growing countries to identify productive and adapted varieties and hybrids based on yields and multipurpose uses under different

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production niches; and funding projects and developing new initiatives for collaborative research on drought tolerance, cold tolerance and others – especially with regard to the threats posed by climate change. It is well to remember that sustainable coconut cultivation, which includes access to high yielding and disease-free germplasm is fundamental to poverty alleviation among smallholders in developing countries. One of the main problems identified with regard to the data and hence the viability of the common pools is obtaining updated information about conserved germplasm. Existing information is obsolete. A main limiting factor of this updating process is ‘making decisions with obsolete or incomplete information’.23 A recent meeting held in Malaysia in February 2012 listed updating data on existing and new accessions in Malaysian coconut genebanks as urgent. The Banana Asia Pacific Network: BAPNET (The Asia Pacific Section of the International Banana and Plantain Network of Bioversity International) The Banana and Plantain Section of Bioversity International was formerly the International Network for the Improvement of Banana and Plantain (INIBAP). Its Asia Pacific Section, referred to as BAPNET, comprises Bangladesh, China, India, Indonesia, the Philippines, Sri Lanka, Vietnam, Fiji, Malaysia, Papua New Guinea, Thailand and Taiwan. Through their national repository, multiplication and dissemination centres, BAPNET has undertaken a project since 2001: •

•

to make improved banana hybrids/varieties developed by breeding programmes from all over the world available to Asian and Pacific countries for yield performance evaluations by researchers/farmers and their eventual adoption by farmers, in order to improve the banana industry, increase the income of rural farmers and increase food security; and to evaluate and promote the use of improved banana hybrids and popular local varieties in Asia and the Pacific.24

The object is to make improved high-yielding, pest and disease resistant varieties available to Asia Pacific growers for purposes of testing and adaptability to their farmers’ local environment. These varieties are available in INIBAP’s genebanks. Both dessert and cooking bananas are available, which are an important staple for farmers and serve as an alternative food source during the ‘hungry period’ between the harvest of other crops. Adoption of these varieties in Asia may make a significant contribution to food security. To facilitate wide distribution in response to numerous requests, national repository, multiplication and dissemination centres (NRMDCs) have been established in participating countries. These centres provide ready access to improved varieties for researchers

A common pools strategy for GRFA in Malaysia 145 and farmers. To overcome the restriction on the movement of planting material between countries due to quarantine regulations, these centres are expected to produce planting materials in quantities sufficient to meet national needs. Such activity has been undertaken with regard to virusindexed improved banana hybrids/varieties (five rooted plantlets each). Further, 21 hybrids/varieties have been made available to the centres. Wide participation is encouraged and the materials are provided by the centres at cost to state colleges, department of agriculture regional units, NGOs, farmers’ cooperatives or any individual grower to carry out field trials which focus on yield performance, which includes adaptability to local soil and climatic conditions and, more importantly, to the prevailing pests and diseases in the area.

The draft ASEAN Framework Agreement on ABS In 2005, the ASEAN Environment Ministers adopted the ASEAN Framework Agreement on Access to, and Fair and Equitable Sharing of Benefits arising from the Utilisation of Biological and Genetic Resource (the ASEAN Framework Agreement).25 An introductory paragraph highlights the need to ensure consistency of access regulations in the region by establishing minimum standards for national implementation. Two statements of principles in operational Article 2 are instructive. The first states that: ‘[T]he Parties recognize the importance of ensuring that food security in the region is enhanced and therefore emphasize the importance of facilitating the exchange and utilisation of food crop germplasm, where possible.’ A follow-up principle mandates parties to foster mutual cooperation in implementing this Agreement ‘in view of shared biological resources and the different levels of development’. Yet another principle envisages that parties ensure the fair and equitable sharing of benefits arising from the utilisation of their biological and genetic resources at the regional level, in addition to the community and national levels. These statements of principles, which frame the context within which the other provisions of the Agreement are to be implemented, provide a clear basis for implementing at the regional level common pools for the free use and exchange of PGRFA. As noted earlier, there are already several regional pools that facilitate the exchange of germplasm subscribed to by some ASEAN member countries. There are also international pools of which ASEAN countries are members. The ASEAN member countries could subscribe as a region, rather than as individual members, to these international common pools. The establishment of the Regional Clearing House Mechanism (Article 11) provides a useful institutional structure to deal with third party users of resources that are endemic to the region. The mechanism is tasked with establishing a database of the region’s biological and genetic resources and associated traditional knowledge (TK) (Article 11.2(c)). This would

146 Gurdial Singh Nijar bring about greater coherence within the region in respect of shared resources and advance the cause of the common pooling of these resources. The Common Fund for Biodiversity Conservation (Article 12) quite clearly envisages parties making financial contributions to the fund. These contributions can be expected to be made by countries from the implementation of their ABS laws and lead to encouraging regional ABS approaches to shared resources. Indeed the Agreement recalls in an introductory paragraph the numerous decisions of the Conference of the Parties of the CBD encouraging just such approaches. An early initiative of the Regional Clearing House in furtherance of its task to establish a database of the region’s biological and genetic resources could be the documentation of the materials in the regional and/or international agreements of which ASEAN parties are members. This will provide full, easily consultable information of the individual accessions available. This, of course, implies that there is agreement for parties that are members to make the resources available to others who are not members. The information could be provided on a website and contain detailed data on the composition of the collection and user procedures to ensure that the materials are readily available, similar to the proposal for resources covered by the MLS under the Treaty. The Secretariat established by Article 9 should keep abreast of all these available accessions through notifications made to it by members and make this information available on its website.

Conclusion This chapter has outlined the basis upon which a common pool strategy for GRFA may be advanced. First, the draft national law doing the paces of stakeholder consultations in 2013 has provisions that allow for the exclusion of certain biological resources from its strict access and benefit-sharing requirements. These include those that are critical for food security and which need to be freely used and exchanged so as to enrich the national genepool. The law also excludes those resources subject to international access and benefitsharing arrangements, to which Malaysia is a party. Thus, excluded would be the Annex I crops listed under the ITPGRFA which are subject to the MLS of exchange. The law also envisages the exclusion of crops that are the subject of regional and international exchange pools. Finally, the law exempts biological resources that are accessed by indigenous and local communities for non-commercial and R&D purposes, as well as their use and exchange among themselves in the exercise of their traditional and customary practices. Second, the implementation of the MLS of the Treaty is long overdue. The main repository of collections of PGRFA is a statutory body – MARDI. An analysis of its governing statute concludes that it is indeed performing

A common pools strategy for GRFA in Malaysia 147 governmental functions and hence comes within the ambit of the Treaty. Its role should be clarified so that it can operationalize the MLS provisions. Third, although in draft form for several years, the ASEAN Draft Framework Agreement on ABS envisages cooperation to develop facilitative mechanisms for the utilization and exchange of food crop germplasm to ensure food security in the region. In this respect, the member countries can build on the regional and international common pools of which they are members. Finally, the realization of the strategy for the development of common pools depends critically upon the sharing of information with regard to where the resources are located and how they can be accessed. This requires the establishment of a comprehensive and easily consultable database that is efficient and updated. The various facets examined by this chapter all clearly point in the direction of the need for, and the development of, such an informational architecture to advance the cause of common pools, which will allow for the efficient free use and exchange of key GRFA. Supplemented by automatically applicable standardized ABS contracts such as the SMTA under the MLS of the Treaty, there will be a firmer basis for ensuring food security in the future.

Notes 1

2 3 4 5 6 7 8 9 10 11 12 13 14

However, the member countries have yet to agree to the 2005 draft Framework Agreement on Access to, and Fair and Equitable Sharing of Benefits arising from the utilization of, Biological and Genetic Resource (ASEAN draft ABS law). This draft supersedes an earlier 2000 draft. This bilateral arrangement has been reinforced by the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits arising from their Utilization (Nagoya Protocol) adopted in 2010. ITPGRFA, Article 10 (on the establishment of the MLS); Article 11.1 (on MLS for PGRFA in Annex 1). Article 11.2. Minister of Immigration and Ethnic Affairs v Teoh (1995) 69 Aus L.J. 423. R v Secretary of State for Home Department ex parte Mohammad Hussain Ahmad 1998 ENCA (Civ) 1345, 1347. Vishaka v The State of Rajasthan AIR 1997 SC 3011. The UK Court of Appeal judicially recognized this practice: per Lord Denning in Trendtex Trading Corporation v Central Bank of Nigeria [1977] QB 259. This section has been explored and forms part of a study undertaken by the author as director of CEBLAW for Bioversity International (Nijar 2012). [1977] QB 259. [1971] 1 WLR 604. [1971] 1 WLR 604, at 609. [1982] 1 LNS 83. The other criterion under Article 11.2 is that the PGRFA must be ‘in the public domain’. This is a qualification of a legal nature. In this context, it means materials that are not protected by intellectual property rights (IUCN 2005: 84). Such materials are not automatically included in the MLS, although the holder of such right may include them in the system voluntarily.

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15 Established by an act of Parliament – the University Malaya Act 1961 (Revised 2007). 16 See http://www.globinmed.com/index.php?option=com_content&view=article &id=46:list-of-herbaria&catid=154&Itemid=130, viewed 14 January 2013. 17 Ketua Pengarah Jabatan Alam Sekitar and Others v Kajing Tubek Jok Jau Evon and Others [1997] 3 MLJ 23. 18 A review of this will likely start at the 5th session of the Governing Body in 2013 (Governing Body 2010). 19 The banana and plantain group was originally conceived as a networking organization called INIBAP. After more than 20 years of networking experience, it became part of Bioversity International. It continues to address the conservation, research and development objectives using an approach based on partnerships and networks. Although Bioversity International carries out strategic research, much of the laboratory or fieldwork is outsourced, and Bioversity’s main role is to engage diverse partners and stakeholders in multiple countries, facilitate and coordinate research agenda, and ensure high-quality research products and Global Public Goods are produced, http:// bananas.bioversityinternational.org, viewed 16 January 2013. 20 Other networks include: International Network for the Improvement of Banana and Plantain (INIBAP) and the Asian Cassava Research Network (ACRN). No further information could be obtained for these networks. 21 COGENT currently has 39 member countries that are divided into five subnetworks: Southeast and East Asia (China, Indonesia, Malaysia, Myanmar, Philippines, Thailand and Vietnam); South Asia and Middle East (Bangladesh, India, Pakistan, Sri Lanka and Sultanate of Oman); South Pacific (Cook Islands, Fiji, Kiribati, Papua New Guinea, Samoa, Solomon Islands, Tonga and Vanuatu); Africa and the Indian Ocean (Benin, Côte d’Ivoire, Ghana, Kenya, Madagascar, Mozambique, Nigeria, Seychelles and Tanzania); and Latin America and the Caribbean (Brazil, Colombia, Costa Rica, Cuba, Guyana, Haiti, Honduras, Jamaica, Mexico and TrinidadTobago), http://www.cogentnetwork.org/index.php/about-cogent, viewed 14 January 2013. 22 http://www.cogentnetwork.org/index.php/about-cogent, viewed 14 January 2013. 23 Communication with the COGENT Coordinator, February 2012. 24 For the projects, see http://www.promusa.org/tiki-searchindex.php?find=proj ect+since+2001&where=pages&boolean=on&boolean_last=y&go=Go&exact_ match= , viewed 14 January 2013. 25 For a detailed analysis and comparison with an earlier 2000 draft, see Nijar (2008).

References Correa, C (2010) ‘Annex to AC-SMTA-MLS 1/10/4, IT/AC-SMTA-MLS 1/10’, Report on the first meeting of the Ad Hoc Advisory Technical Committee on the Standard Material Transfer Agreement and the Multilateral System of the Treaty, FAO, Rome. FAO (2007) Country report on the state of plant genetic resource for food and agriculture, Malaysia (1997–2007), Rome, http://www.fao.org/docrep/013/i1500e/Malaysia. pdf, viewed 17 January 2013. Governing Body of the International Treaty on Plant Genetic Resources for Food and Agriculture (2010) Opinion on identification of PGRFA under the management and control of contracting parties and in the public domain, IT/AC-SMTA-MLS 1/10/

A common pools strategy for GRFA in Malaysia 149 Report, Appendix 3, http://www.planttreaty.org/sites/default/files/ac_smta_ mls1_repe.pdf, viewed 17 January 2013. Moore, G and Tymowski, W (2005) Explanatory guide to the International Treaty on Plant Genetic Resources for Food and Agriculture, Environmental Policy and Law Paper No. 57, IUCN, Gland, Cambridge. Nijar, GS (2008) ‘Legal issues and frameworks relating to national and ASEAN access and benefit sharing of biological resources: current status and future needs’, in Mohd, SN, Salma, I and Mohd, SS (eds), Agrobiodiversity in Malaysia, MARDI, Kuala Lumpur, pp. 150–171. Nijar, GS (2012) Malaysia’s implementation of the multilateral system of access and benefit sharing, CGIAR, Rome; MARDI, Kuala Lumpur. Nijar, GS, Gan, PF, Lee, YH and Chan, HY (2011) Food security and access and benefit sharing for genetic resources for food and agriculture, South Centre, University of Malaya and CEBLAW, Geneva, Kuala Lumpur. Tansey, G (2008), ‘Farming, food and global rules’, in Tansey, G and Rajotte, T, The future control of food, Earthscan, London.

8

Common pools of traditional Chinese medical knowledge in China1 Tianbao Qin

Introduction In recent years, traditional medicinal knowledge (TMK) has attracted the attention of multinational corporations from developed countries, which are interested in the potentially substantial commercial value of some of these TMK-derived products. Although a large portion of TMK originated in developing countries, those countries and their local communities have not effectively supervised this knowledge in order to derive financial or ownership benefits from it. China represents one of the best examples of a developing country rich in TMK, which has not effectively converted this knowledge into an ownable and protectable asset. Instead, other bodies or entities have ‘misappropriated’ China’s TMK, either by accessing it and using it at a very low price or by treating it as a ‘common pool’ item and, therefore, not compensating anyone for its utilization at all. The issue of benefit sharing concerning genetic resources in general has drawn great attention by both academia and competent departments in China. But the situation with access and benefit sharing (ABS) of TCMK has seldom been mentioned. Should ABS be taken into account when considering TCMK? If so, how should the benefit be shared? Do the existing laws provide legal ground for ABS? This chapter tries to provide a legal analysis of the current situation on ABS with regard to traditional Chinese medical knowledge (TCMK).

TMK and TCMK TMK, which is also referred to as traditional medicinal theory, has a different format and content compared with modern medical theory. TCMK includes TMK of Han Nationality and TMK of China’s minority nationalities, such as that belonging to the Tibetans, Miao, Mongolians, etc. TMK also includes a large amount of knowledge on folk herbs knowledge. In this chapter, the ‘common pools of TCMK’, which includes these China-based types of TMK, refers to the TCMK over which ownership is absent, uncertain and/or cannot be confirmed.

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In China, TCMK ownership/holdership can be classified into four categories: 1

2

3

4

Family-held knowledge, sometimes called ‘secret family recipes’, which is handed down within a specific family, is not allowed to spread, and has a special inheritor. In this type of situation, the special inheritor can apply for a ‘trade secret’ to become the right-holder or can apply for a patent to become a patent holder. Collectively-held knowledge, which is typically held by a particular group or local community but only known well by one individual among the collective. For example, in rural China, there are a large number of ‘barefoot doctors’2 who accumulate and disseminate TCMK through their work with local groups and communities. The TCMK that the doctors learn represents part of a collective knowledge which may belong to these particular groups or communities. Collectively-known knowledge, which refers to TCMK known and used in a certain geographic area by local communities but whose ownership/ origin is difficult to determine. Public knowledge, which refers to TCMK known and utilized by the general public on a consistent basis.

Of these four categories, the third and fourth ones tend to be most utilized by ‘common pools’ and, therefore, most exploited by those seeking to commoditize TCMK without taking ABS into consideration. Alternatively, TCMK may be categorized according to the form of storage. Three subgroups appear in this regard: 1

2

Documented TCMK, which refers to the TCM or TMK books which originated during the Chinese dynastic era and have been passed down to modern Chinese ancestors. These books not only contain traditional medical theory pertaining to drugs, prescriptions, disease, diagnosis, treatment and the like, but they also contain TCM-relevant information regarding processing technology, discriminating, concocting, cultivating and breeding knowledge of traditional medicinal materials, traditional medicinal prescriptions and traditional diagnosis and treatment technology. One of the most famous examples of this type of TCMK book is Inner canon of yellow emperor by Huang Di Nei Jing, The compendium of materia medica by Ben Cao Gang Mu, and Treatise on cold pathogenic and miscellaneous diseases by Shang Han Za Bing Lun. TCMK databases, which primarily refer to the common pools of TCMK collected, compiled and collated by databases through modern information technology. Nowadays in China, a large part of information in TCMK databases comes from the book-based documented TCMK mentioned above – in essence representing the

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Tianbao Qin electronic version of documented TCMK. TCMK databases are run by different operators; some are free to users and others charge users a fee to access them. Knowledge by oral dissemination, which refers to TCMK communicated among local communities through the spoken word. Knowledge by oral dissemination typically comprises treatment methods for common diseases or the statement on incompatibility of Chinese medicine. For example, it is often orally disseminated among select Chinese communities that the horn of the Tibetan antelope in western China can cure a child’s cold or fever efficiently. To effectively utilize this TCMK-derived remedy, when the child contracts a cold or fever, parents chip a small piece of the horn, grind it into powder, and then put the powder into warm water for the child to drink. Upon consuming this liquid remedy, TCMK indicates that the child should quickly recover from his or her cold or fever.3 Another example of orally disseminated TCMK-derived knowledge is consumption of poppy capsules. Poppy capsules can cure a persistent cough. However, they should not be used on a cough during the early stages of contraction nor should they be utilized in excess due to their toxic and addictive properties, particularly among pregnant women and children.

A third way to categorize TCMK is based on the different ways that TCMK can be accessed. Using this categorization method, TCMK can be divided into direct and indirect access. TCMK which can be directly accessed includes documented TCMK and TCMK by oral dissemination since it can be accessed by reading, inquiring or talking with the residents in a local community or a specific area. TCMK which can be indirectly accessed includes TCMK databases since these can only be accessed by a limited group of individuals due to certain conditions such as the payment of an access fee or the conclusion of an access agreement.

The legal status of common pools of TCMK Until recently, there were no specific laws about ABS of common pools of TCMK in China. However, within the existing laws, administrative regulations, and local laws in China, there are some preliminary rules about administration, access to, and sharing of activities. The rules on administrative authority There are no specific laws on the right-holder of common pools of TCMK in China. The 1982 Constitution and the 2001 Law on Regional National Autonomy, which is a basic law formulating fundamental policy and system concerning minority nationalities in China, can both be understood to

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provide that state and local governments have the authority to manage common pools of TCMK. Article 21 of the 1982 Constitution says China should develop TCM and Article 119 states the organs of self-government of the national autonomous areas should independently administer educational, scientific, cultural, public health and physical culture affairs in their respective areas; protect and sift through the cultural heritage of the nationalities; and work for a vigorous development of their cultures. Article 38 (2) of the Law on Regional National Autonomy, which was revised in 2001, states: The organs of self-government of national autonomous areas shall […] collect, sort out, translate and publish historical and cultural books of minority nationalities and protect […] important historical and cultural legacies, so as to inherit and develop their outstanding traditional culture. Moreover, Article 41 (1) of the Law on Regional National Autonomy authorizes the governing organs of national autonomous areas to make independent decisions regarding plans for developing local medical and health services and for advancing both modern medicine and the traditional medicine of the nationalities. The ‘cultural heritage of the nationalities’ referred to above includes tangible objects and places, as well as intangible cultural expressions and ideas which reflect national cultural characteristics of historical significance which have been inherited from earlier Chinese generations. Common pools of TCMK can be regarded as the cultural heritage of the Chinese Han and minority nationalities. The Constitution and associated laws use the terms manage and develop to represent the encouragement and supportive attitude of national competent departments and the local governments to the dissemination and development of TCMK (including common pools of TCMK). And these rules also illustrate that the national and local governments are not the owners of common pools of TCMK but, rather, simply represent TCMK’s custodians or guardians. These governments have the authority to regulate access to common pools of TCMK as well as to promote the proper and responsible utilization of TCMK. The rules on access to TCMK In China, there are no specific laws explicitly regulating access to TCMK (including common pools of TCMK). But the Regulations on TCM in 2003 stressed China’s willingness to support and protect TCM. Article 24 in the Regulations on TCM states that access to significant research achievement derived from TCMK (including common pools of TCMK) by foreigners shall be approved by the competent department. It also indicates that, in

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order to prevent the loss of major traditional Chinese medical resources and to safeguard China’s national interests, access to TCMK (including common pools of TCMK) is subject to regulation by the competent department. In addition, some local legislators have established rules to encourage access to or utilization of preparations4 from TCMK (including common pools of TCMK). Article 15 (3) of the Regulations of Heilongjiang Province on Development of TCM in 2008 stipulates that, on approval from the Food and Drug Administration, designated hospitals can access preparation based on TCMK (including common pools of TCMK) with other hospitals. 5 Article 33 (2) of the Regulations of Sichuan Province on TCM of 2009 stipulates that a ‘counterpart support agency’6 can share preparation information based on TCMK (including common pools of TCMK) with each other. Article 41 of the Regulations of Shenzhen City on Protection of TCM of 2010 states that in the event of a sudden public health crisis such as Severe Acute Respiratory Syndrome, preparations based on TCMK (including common pools of TCMK) can be shared freely.7 The rules on sharing activities Article 3 (2) of the Law on Promoting the Transformation of Scientific and Technology Achievement of 1996 stipulates the basic principles on sharing activities of scientific data. It writes that persons concerned shall abide by the principles of voluntariness, mutual benefit, fairness and good faith and shall, in accordance with law or contractual agreement, enjoy interests and bear risks when transforming scientific and technological achievement. Associated intellectual property rights shall also be protected by law. Namely, anyone who wants to share the knowledge under the IPR must reach an agreement with the holder(s) of the IPR. Generally, benefit sharing is a kind of civil transaction, and therefore shall comply with fundamental principles and provisions of civil laws. Article 20 and Article 46 in the Law on Science and Technology Progress in 2007 set preliminary rules on sharing activities and Intellectual Property Rights (IPR) in scientific technology projects supported by State finance. Article 20 (1) of this law stipulates that the right of patent, copyright of computer software, the exclusive right of layout-design of integrated circuits and the right of new plant variety obtained in the scientific technological fund established by state finance or by scientific technological plans, except where national security, national interest or vital public interest are involved, shall be granted to the authorized undertaker of the project. Article 20 (4) sets out that the benefit arising from the exercise of IPR mentioned in Article 20 (1) shall be distributed according to the provisions of relevant laws and administrative regulations; and where such provisions are lacking in laws or administrative regulations, the benefit shall be distributed based on agreements between

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the authorized undertaker of the project and other parties. These provisions represent that the undertaker of a scientific technological project owns the IPR and, therefore, may protect or exercise this right and benefit from it. Article 46 states that those scientific technological research and development institutions should establish the sharing mechanism on scientific technological resources in order to promote utilization effectively. Comments on the legal status of ABS of common pools of TCMK Although current laws, administrative regulations and local laws in China have, as shown, some preliminary rules related to ABS of common pools of TCMK, many design problems remain, including the following: First, the laws in China have no specific rules on ABS of common pools of TCMK. Common pools of TCMK can be accessed freely, but it is not res nullius, which could be claimed for any rights. The laws in China should set rules on right-owner/holder of common pools of TCMK. The situation may aggravate misappropriation by developed countries and does not support the benefit-sharing rights of claimants. Second, China lacks specific laws on common pools. The rules on common pools of scientific data are, at present, simply mentioned in the 1996 Law on Promoting the Transformation of Scientific and Technology Achievement and the 2007 Law on Science and Technology Progress. And the specific rules on ABS of common pools of scientific data are concentrated in administrative regulations and department rules. 8 This concentration within lower-level government-based documents results in these regulations lacking enough upper legal basis to effectively protect and coordinate rules regulating common pools and TCMK. Take the TCMK databases for example: since each database has a different owner, the content, standard and scope of TCMK information varies widely, which leads to multiplication of collection activity and is not helpful to the general protection of TCMK.

Practice in ABS of common pools of TCMK Practice in ABS of common pools of TCMK for direct access The common pools of TCMK for direct access include documented TCMK and TCMK by oral dissemination, which can be accessed directly and freely. It is mainly open to the public and is widely disseminated so that it has become a chief target of misappropriation by multinational corporations from developed countries.

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Box 8.1 The case of Niuhuang qinxin pills Niuhuang qinxin pills (reddish-brown pills) are made according to the original prescription in Taiping huimin heiji jufang [Prescription of peaceful benevolent dispensary]. The function of the pills is to ease the mind, resolve phlegm and arrest convulsions due to phlegm fire; the symptoms of convulsion are always marked by impairment of consciousness, blurred speech, salivation and dizziness, and epilepsy. On 16 May 1989, a Korean citizen applied for a patent on the production methods of an improved oral liquid version of Niuhuang qinxin pills. Another Korean, Kim, applied for a patent on the production of mini-capsules of the pills in Korea, China, Japan and the USA in April 1992. With patents on the so-called preparation and method, Kim took and controlled most of the domestic and international markets for the medication. Source: Adapted from Song, XS (ed.) (2009) Legal protection of TCMK, Intellectual Property Press, Beijing, pp. 281–283

Box 8.2 The case of Scutellaria Decoction (Huang Cen Tang) Scutellaria Decoction is recorded by a very famous doctor, Zhang Zhongjing (AD150–219) of the Eastern Han Dynasty. It has miraculous effects in curing dysentery, acute enteritis, diarrhoea and diseases of the digestive tract, viral colds, etc. However, Yale University applied for a patent on ‘Herb combination PHY906 and its Application in Chemotherapy’ in China and the USA in March 2001 (Application number: 01808197.5). The patent application states that using PHY906, which is actually based on Scutellaria Decoction, improves the therapeutic effect of chemotherapeutics and therapies for diseases of patients suffering from viral infections and cancer (mainly rectal cancer). To date, PHY 906 has been approved by the Food and Drug Administration in the United States and has completed the Phase II experimental period. Source: Adapted from Song, XS (ed.) (2009) Legal protection of TCMK, Intellectual Property Press, Beijing, pp. 281–283

The cases described in Boxes 8.1 and 8.2 illustrate how companies and/or individuals from developed countries have accessed common pools of TCMK and then patented this TCMK for their own use. This pattern of misappropriation of TCMK for private patent is quite common in China. Additional instances of this pattern include, for example, the patenting of mint, which is a common TCM used to cure colds and ease nerve pain, by foreign multinational companies. Americans applied for and received eight patents relating to mint, including four held by the American-based Wrigley Company. Another example pertains to a famous TCM called Liushen Pills (Liushen Wan). These pills have cooling, detoxifying and

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anti-inflammatory properties. When a Japanese company made an improvement on these TCM pills, however, and invented the Instant Cardio-Reliever Pill (Jiuxin Wan), they applied for a patent for it, effectively also patenting the TCM on which this improved pill was originally based. Similarly, another Japanese company applied for a patent on a medicine used to cure Colitis gravis which included Xiaoyao Powder (JiaWeiXiaoYao San), Angelia and Peony Decotion (DangGui Shaoyao Tang), Penoy and Liquorice Decotion (Shaoyao Gancao Tang) and Cinnamon Twig and Poria Pill (Guizhi Fuling Wan), also all remedies originating from TCM.9 A common point in the cases mentioned above is that foreign users access common pools of TCMK freely, free of charge and use the information to develop a medical remedy or procedure for which they obtain a patent in another (usually their own) country. In theory, the originator of this TCMK should be a right-owner/holder of the TCMK used to develop these medical remedies and procedures. However, in practice there is nobody from China involved in these transactions since there are no rules about them in the books and, therefore, no appropriate right-owner/holder can be identified when the patent is issued. This situation demonstrates how developed countries’ misappropriation of TCMK impairs China’s national interests. Although there is no specific right-owner/holder of common pools of TCMK, this should not be an obstacle to benefit sharing between provider and user according to principles of civil law, such as equity and compensation. While the right of an owner/holder to claim benefit sharing is not directly applicable as a rule of international law,10 it is becoming recognized in differentiated form in emerging Chinese practice. In that direction, China should establish a specific law on ABS of common pools of TCMK. Practice in ABS of common pools of TCMK for indirect access The common pools of TCMK for indirect access refer to access to TCMK based on certain conditions and mainly refer to TCMK databases. China has no specific law on databases and no specific regulation on access to databases. According to the principles of ownership, we can divide the databases into two types: state-owned databases and non-state-owned databases. We will legally analyse each situation separately with regard to ABS. State-owned databases TRADITIONAL CHINESE MEDICINE DATABASE SYSTEM11

In 1984, the Traditional Chinese Medicine Database System was established by the Institute of Information on Traditional Chinese

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Medicine (IITCM), China Academy of Chinese Medical Science (CACMS). Currently, the system consists of over 40 categories of Chinese medicine databases, possessing 1,100,000 items of data, including the Traditional Chinese Medical Literature Analysis and Retrieval Database, Clinical Medicine Database, Traditional Chinese Drug Database, Database of Chinese Medical Formula, Traditional Chinese Medicine Enterprises and Productions Database, State Standards Database, etc. The system has two English databases: Traditional Chinese Medical Literature Analysis and Retrieval System (TCMLARS) and Traditional Chinese Drug Database (TCDBASE). Each of the above databases has a CD edition. The system is run and maintained by IITCM and maintenance costs are mostly from database users’ fees and government-provided financing. TCMK included in this system is mainly from official documents and reports, public publications, ancient books and other similar documents. All TCMK in the system can be regarded as common pools. The fee for access to the system is RMB 6,000 (nearly USD 1,000) per year. The system verifies and monitors the user’s IP address to prevent access to other unauthorized users. Users are not required to state their aim in using the system or to sign an access agreement. NATIONAL SCIENTIFIC DATA SHARING PLATFORM FOR POPULATION AND HEALTH (THE TCM CENTER AND THE PHARMACY CENTER)

It is a large data-sharing platform that is funded by national finance for technological innovation, governmental decision-making, public health and health care, research and teaching, and demands for health information from ordinary people. Now the sharing platform has initiated databases such as preclinical medicine, clinical medicine, TCM, pharmacy, public health, and population and reproductive health. The TCM Center also offers a retrieval and inquiry service regarding TCM information, ancient TCM-related books, information on TCM acupuncture, etc. The Pharmacy Center offers a retrieval and inquiry service regarding information about pharmacy administration, pharmacy resources, pharmacy research, development, production and usage, which often represent common pools of TCMK. The information on the sharing platform can be accessed by internet and phone call. And the platform classifies the information into four ranks. Access to information in different ranks should satisfy respective requirements:12 • • • •

rank zero: popular science data, access for free and for the public; rank one: professional data, only for registered users and access for free, subject to registered user’s agreement; rank two: data production or achievement, access for ordinary users, a part of the data must be paid for; rank three: initial data, exchange with the operator and limited sharing only.

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The platform divides users into four categories; users of the different categories have access to different information:13 • • • •

public service user: the government and units or individuals engaged in public welfare; free access after registration; professional user: professional institutes and individuals; access to professional data; industrial user: industry; registration required, payment for services; agreement to be concluded; public user: access to data resources for free.

LEGAL ANALYSIS

ABS between provider and collector (TCMK database) In the case of the Traditional Chinese Medicine Database System, the information in the databases is mainly derived from common pools of TCMK. The collector accesses the information free of charge and does not mention the source or provider on the website of the database. From this case, we find that access by collectors does not follow the general principles of civil law on the exchange of commodities. The core reason for this is: as there are no laws on ownership/holding of common pools of TCMK, in practice nobody can make a claim for benefit sharing to the collector. In the case of the National Scientific Data Sharing Platform, the platform cannot be regarded as a genuine collector but rather as a tool to provide a service to the collection. The information on the platform is offered by different competent departments. For example, TCM information was provided by CACMS and pharmacy information was provided by the Information Center of the SFDA. Competent departments collecting the information for the Platform by inviting interested state-owned research institutions for bids. The bid winner will be funded by the state to establish a database and to offer information to the Platform. The main function of the Platform here is to establish requirements and conditions on access to information for users, and to set out rules and standards on collection, compilation and collation of TCMK for collectors (stated-owned research institutions). In this way, the Platform can be regarded as a ‘bridge’ connecting collectors and users. And it is worth mentioning that when collectors (stated-owned institutions) access information from common-pools of TCMK, they do so without charge and do not mention the sources and/or providers of common pools of TCMK. ABS between collector (TCMK database) and user In the case of the Traditional Chinese Medicine Database System, users should pay before accessing common pools of TCMK. But the fee paid by

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users is not a share in the benefit from utilization of the genetic resource and TK. The fee is a property interest of copyright of the TCMK database for collation or compilation. And it is worth mentioning that the fee paid by users is not applied to protection or inheritance of common pools of TCMK but operation of the TCMK database. The collector does not require the user to mention the source or provider during the process of utilization or to sign an access agreement. We have found that the collector does not claim for benefit for the original provider, thereby impairing the interests of the right-owner/holder. And we have also found that the collector does not conclude an agreement with the user so that the user can apply for IP protection based on common pools of TCMK, thereby once more impairing the interests of the right-owner/holder. In the case of the Sharing Platform, users may access a large amount of information for free, though some data productions or research achievements are treated differently. According to the rules set by the Platform, the charge on some information should be submitted not to the state-owned institute (i.e. the collector) but to the Platform, and the Platform may distribute benefits between competent department, research institute, information producer14 (if it can be confirmed or determined) and itself, according to IPR.15 This allocation by the Platform is a share in the benefit of utilization of common pools of TCMK, as it takes the interest of the provider (information producer) into account and it also indicates that sharing activity should not only satisfy the principles of civil law but also consider the balance between cost and benefit. If the user accesses the information offline through CD-ROM, he/she must pay a handling charge and sign a data access agreement.16 However, only the information in a specific sub-database on drug screening and new pharmaceuticals is subject to these restrictive conditions. The agreement requires the user to provide personal information, the duration of utilization and the goal of access. The agreement also stipulates some important restrictions on access as follows: (1) users are not allowed to provide the information to third parties for free or a fee; (2) users are not allowed to resell information for profit and offer it to other databases (regardless of whether the database aims at business or research); (3) users are not allowed to do business using these data; and (4) users shall mention the source or provider when research or development achievements are published.17 Although the agreement is not designed for common pools, it offers a useful model for establishing access agreements on common pools of TCMK. We have found that the off-line agreement emphasizes the aim and intention of access, and it is helpful for the collector to control the user’s behaviour and prevent misappropriation. This case also shows that sharing activities are not unrestricted or completely unconditional. In some cases the user must bind him/herself to respect the other’s right when pursuing his/her own interest.

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Non-state-owned databases THE CASE OF THE ENCYCLOPEDIA OF CLASSICS OF TCM18

The Encyclopedia of Classics of TCM website sells ancient TCM books and documents. The Encyclopedia of Classics of TCM is the first e-book of collation and compilation of TCM by Chinese people. It records nearly 1,000 ancient books published before the 1920s and stores more than 400 million words. Many users from East-Asian countries like Japan and Korea buy books and documents from the website in spite of the exorbitant prices. The user pays RMB 500 (about USD 80) to acquire one copy of an e-book. This database does not set restriction rules on access or utilization and does not require the user to mention the aim of access and sign an agreement. LEGAL ANALYSIS

ABS between provider and collector In this case, the database makes a profit through collecting TCMK into a common pool. Again, as mentioned above, there is no specific law on right-owners/holders in China and therefore the collector’s access to information is free. The collector also does not ensure benefit sharing of the user with the provider. The collector, in this case, also acts against the general principle of civil law transactions. This is, however, due to the same problem, namely that when appropriate legislation is absent, the owner/right-holder cannot be identified. ABS between collector and user As an enterprise, the collector has no duty under existing law, not even an incentive, to find out for what purpose the user seeks access with regard to profit-making. Its main concern is the sale of information from the database. As in the case of the Traditional Chinese Medicine Database System, the collector does not mention the provider or source in the database and does not sign an agreement with the user. Summary In China, the user can access common pools of TCMK through databases. As there is no specific law on right-owner/holder of common pools of TCMK, access to information on databases in China has somehow been lacking legal ground. A large number of TCMK databases in China do not sign access agreements with users and do not mention the source or provider of common-pools of TCMK. This impairs the interests of the

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right-owner/holder. Under such circumstances, it is necessary for China to establish a specific law or regimes to solve the problem.

Legislative suggestions for ABS of common pools of TCMK in China Access to TCMK involves three parties, namely: the provider (right-owner/ holder of TCMK), the collector and the user. The provider, as the owner/ holder of the TCMK, should enjoy rights in civil law to claim benefit sharing with the user who had access to common pools of TCMK. Therefore, China should enact specific legislation on ABS of TCMK explicitly defining the rights of the provider, especially ownership and other relevant rights. The reason that we should take the right (ownership) as a starting point to legislation can be summarized as follows: First, the essence of ABS on common pools of TCMK is the realization of collective rights of local community(ies). The legal status of local community(ies) as the owner and/or holder of TCMK has been recognized and supported generally and widely by legal researchers and practitioners in China. It is almost uncontested that the right of local community(ies) to TCMK should belong to the body of civil law rights, even though its content remains controversial. On the other hand, since the type and nature of activities of access to common pools of TCMK are complex, local communities may have no awareness and/or capacity to fully realize their rights. Therefore, alternatively, the state (through its competent department(s)) might be entrusted with exercising those rights on behalf of local community(ies). Second, access to common pools of TCMK is a civil transaction from the legal perspective. No matter if access to common pools of TCMK is done directly or indirectly (collection, compilation or collation from databases),19 the provider has the right to claim for benefit sharing. If the user refuses benefit sharing, this should constitute an infringement and should trigger liability to compensation. This may, however, differ from ordinary compensation in that the user should be required to conclude a benefit-sharing arrangement with the right-owner/holder. The benefitsharing arrangement includes monetary and non-monetary benefits; especially in the case of non-monetary benefits, the user should respect the intellectual contribution of the provider, for example, by indicating the source or provider in a publication or research achievement, etc. Recently, discussion on the subject of TK associated with genetic resources has gradually reached a consensus. Nowadays, more and more commentators accepted that a local community which develops and provides TK is entitled to share the benefits. For example, one scholar argued:

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For the subject of TK, the investigation shows that traditional culture expression is developed by and belongs to the community, and the individual is only an inheritor. The conclusion is the same with WIPO. It is also possible for an individual and/or family to hold a TK. But for TK in public, it is impossible to confirm that they belong to or are held by an individual or a family. (An 2008: 61) To this end, one author pointed out: Therefore, to establish the collective management organization is a better solution than individual ownership of TK. And in cases of ‘biopiracy’ or misappropriation by foreigners, the state shall act as the agent to protect TK on behalf of the local community. (Yang 2006: 18) And some authors supported this position: To define the local community as the owner of IPR over TK accords with the communal characteristics of TK, and embodies a right to development of the local community. For the purpose of practical operation, the local community can establish a specific management organization that is responsible for the protection and sustainable development of TK, for obtaining the benefits and for participating in litigation to safeguard the interests of residents. (Li and Xu 2007: 15) The suggestion that the state (through its national competent department) shall act as holder of common pools of TCMK receives general support because of its legitimacy and feasibility. The 1982 Constitution rules that the organ of self-government of the national autonomous areas has authority to regulate TCM because TCMK, as a precious national treasure and intangible cultural heritage, is vital to promote national health. In addition, the special situation of China suggests that the state (through its national competent department) can be a holder of common pools of TCMK. Articles 9 and 10 of 1982 Constitution and Articles 46 to 52 and Article 58 of the 2007 Law on Real Right set rules about the ownership of natural resources in China, which provide that nearly all natural resources belong to the state or collective. Such public ownership entitles the state and collective as owners to manage and distribute natural resources (including TCM resources). The material base of TCMK is TCM resources, so that the management or distribution of TCM resources is to a certain extent the same as that of TCMK. In cases that TCMK has no explicit owner and/or holder, the competent department representing the state can be regarded as holder of common pools of TCMK.

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Although the local community as the owner of TCMK (including the common pools of TCMK) is widely recognized, ‘local community’ is not a legal term and has an uncertain content and scope according to China’s existing law. In order to realize the collective rights and interests of a local community, one sound solution is to establish a collective organization confirmed by law. In this regard, China has gained sufficient experience in the benefit sharing of music in Karaoke by the Music Copyright Society of China20 and China Audio–Video Copyright Association (CAVCA)21. For a long time, music and audio–video programs played in Karaokes (singinghalls) in China have been free and the copyright has not been protected effectively. From 2007 on, CAVCA began to collect copyright fees in the singing-halls in the Shanxi Province, Yunnan Province, Shandong Province and Xinjiang Uygur Autonomous Region with a total of RMB 12 (nearly USD 2) per room per day,22 and distributed the fee among registered members and non-registered members of CAVCA. Except for music with an explicit owner/holder of a copyright, CAVCA sets benefitsharing rules on common pools of music television. Namely, CAVCA keeps the ratio of interest for music with inexplicit owners/holders for a certain period; after that, CAVCA shares the benefit among all other owners/ holders.23 The practice of CAVCA reflects the idea that members who have the same interest can, by establishing a juridical association, realize their collective interest more effectively through a stable organization and a standard operational mechanism.

Concluding remarks The derogatory utilization or misappropriation of common pools of TCMK from developed countries impedes China’s national interests. In China, TCMK common pools, which are accessed both directly and indirectly, are not properly protected by sufficient laws. China should enact specific laws on ABS of common pools of TCMK and on common pools. China began its Law on Traditional Chinese Medicine legislation in March 2005. After seven years, the draft was submitted for review by the State Council in 2012. Although there are high hopes about the protection that this law will provide to originators of TCM, the ABS of common pools should also be administered through specific administrative regulations. In addition, China is a party to the CBD and a signatory to the Nagoya Protocol. These international instruments clearly encourage China to enact specific laws on genetic resources associated with TK (including TCMK).

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Notes 1

This chapter received support from the ‘Common Pools of Genetic Resources’ project of the Forschungsstelle für Europäisches Umweltrecht (FEU), Faculty of Law, University of Bremen. The study was also supported by the Program for New Century Excellent Talents at Wuhan University (NCET-10-0617) and the key project of National Social Sciences Foundation of the People’s Republic of China (11AZD105). The author is grateful to Mr. LI Yiding, a PhD candidate at Wuhan University, for his assistance in conducting field studies and the writing of this chapter, and Professor Gerd Winter and Dr. Evanson Chege Kamau, for their valuable comments and generous help in the proofreading of this chapter. 2 ‘Barefoot doctor’ refers to a village doctor providing diagnosis or treatment to village communities using TCMK without having acquired certification as a doctor. The barefoot doctor is always a respected old villager and does not collect a fee from patients. So the barefoot doctor in the villages of China is welcomed and highly praised. 3 The author had a similar experience himself. According to his father, TK about the horn of Tibetan antelopes being able to cure the cold or fever of children is spread in a specific area in Sichuan, Tibet, western part of China. His father was told the TK by a neighbour who was a soldier in that place. 4 The Chinese medicine preparation refers to the forms of TCM for medical treatment or prevention before clinical applications, such as the troche, injection, aerosol, pill or powder, etc. The preparation is made on the basis of TCMK. For the preparation, a production licence is not required; nor is a permit needed for medical institutions if they agree to TCMK between themselves for public interest purposes. 5 See also Article 16 in Regulations of Guizhou Province on development of TCM (2002) (Chinese version can be accessed at http://gxw.gygov.gov.cn/art/2011/ 8/4/art_975_9445.html) and Article 14 in Regulations of Guangxi Zhuang Autonomous Region on development of TCM and Zhuang Medicine (2008) (Chinese version can be accessed at http://www.gov.cn/flfg/2008-12/23/content_ 1185536.htm). 6 ‘Counterpart support’ is a political policy to keep the balance of development in China that includes assistance in case of disaster, or economic, educational or medical need. 7 See also Article 35 in Regulations of Sichuan Province on TCM (2009) (Chinese version can be accessed at http://www.satcm.gov.cn/web2010/zhengwugongkai/ zhengcefagui/falvfagui/xingzhengfagui/2010-10-07/9289.html) and Article 35 in Regulations of Inner Mongolia Autonomous Region on TCM and Mongolian medicine (2010) (Chinese version can be accessed at http://www.btwsj.gov.cn/contents/ 7/6922.html). 8 Currently, regulations about sharing activity on common pools resources appears only in department rules such as The implementation plan for running the National Scientific Data Sharing Platform for Population and Health (Draft), (Chinese version can be accessed at http://www.ncmi.cn/UploadFile/0/1/ eb7fe4bb658d7746eb09b0625bbe6910.pdf) viewed 15 January 2013. 9 China’s Traditional Chinese Medicine Newspaper, the third forum, 9 July 2009. 10 The preamble to the Nagoya Protocol on access to genetic resources and their fair and equitable sharing of benefits arising from their utilization to the Convention on Biological Diversity (2010) states that the parties to the Protocol: ‘[recognize] the unique circumstances where traditional knowledge associated with genetic resources is held in countries, which may be oral, documented or in other

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11 12 13 14 15

16 17

18 19 20

21

22

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forms, reflecting a rich cultural heritage relevant for conservation and sustainable use of biological diversity’. Adapted from the brief introduction to the Traditional Chinese Medicine Database System. For more details, see the Chinese language website http:// www.cintcm.com/opencms/opencms/index.html, viewed 3 July 2011. See The implementation plan for running the National Scientific Data Sharing Platform for Population and Health (Draft), p. 13. See The implementation plan for running the National Scientific Data Sharing Platform for Population and Health (Draft), p. 14. The information producer here can be understood as the right-owners/ holders of TCMK. From the rules, we could assume, as there is no direct benefit sharing between provider and collector in this case, that the benefit is allocated to the provider (namely the information producer), the collector (namely the state-owned institute), the platform and the competent department at the same time. See more in Article 41 of the Regulations on running and managing the National Data Centers (Networks) (Draft), (Ministry of Science and Technology of People’s Republic of China, November, 2004), (Chinese version can be accessed at http://ncmi-pharm.sfda.gov.cn), view 15 January 2013. See more in Article 40 of the Regulations on running and managing the National Data Centers (Networks) (Draft), (Ministry of Science and Technology of People’s Republic of China, November, 2004). For more details on the application on access to the scientific data of pharmacy and innovative drugs from offline users, see the Chinese language website http://www.pharmdata.ac.cn/virtualcompound/index.asp, viewed 20 March 2012. For further details, see the Chinese language website http://www.tcmbook.cn, viewed 3 July 2011. Collection, compilation and collation from databases constitute the main forms of use. According to theory on civil law, the right-owner/holder should be repaid. The Music Copyright Society of China (MCSC) was established on 17 December 1992. It is a non-profit social organization with the status of a legal person in whose name the Chinese music copyright owners exercise their rights by way of collective management. The China Audio–Video Copyright Association (CAVCA) collectively manages the copyright and related rights of audio–video programs according to the law. It aims to safeguard the legal rights of its members, regulates the legal use of audio–video programs and enhances the development of the audio–video industry and the market in China. According to the Law on copyright (2010) in China, the lyricist and composer of television music has/have the copyright and the actor, producer and publisher have neighbouring rights – i.e. rights extended to non-authors closely connected to the production of the copyrighted work. CAVCA would collect the fees that belong to the lyricist, composer, actor, producer and publisher at the same time. Personal interview and communication by the author with a CAVCA staff member.

Bibliography An, S (2008) ‘Analysis on the subjects and objects on protection of traditional knowledge in view of local legislation’, Intellectual Property, no. 3, pp. 59–63.

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Carrizosa, S, Brush, SB, Wright, BD and McGuire, PE (eds) (2004) Accessing biodiversity and sharing the benefits: lessons from implementation of the Convention on Biological Diversity, IUCN, Gland and Cambridge. Li, C, and Xu, H (2007) ‘Chuantong zhishi de zhishi chanquan baohu zhengdangxing yanjiu: yi shequ wei xin quanli zhuti’ (unofficial English translation: ‘The research on legitimacy of intellectual protection on traditional knowledge: taking community as a new stakeholder’, Presentday Law Science, 3, 11–17. Qin, T (2006) Legal issues of access to genetic resources and benefit-sharing, Wuhan University Press, Wuhan. Qin, T (2009a) ‘Improvement of legal system on access to genetic resources and benefit-sharing in mainland China’, The Taiwan Law Review, (166), 163–184. Qin, T (2009b) ‘Several issues of international law on genetic resources and biopiracy and their latest development’, Science and Technology Law Journal, 2, 115– 154. Qin, T (2009c) ‘The process of legislation on ABS in China: a new long march’, in Kamau, EC and Winter, G (eds), Genetic resources, traditional knowledge and the law: solutions for access and benefit sharing, Earthscan, London, pp. 225–241. Song, X (2009) Legal protection of TCM knowledge, Intellectual Property Press, Beijing. Xue, D (2009a) Case studies for access and benefit-sharing of genetic resources in ethnic areas of China, China Environmental Science Press, Beijing. Xue, D (2009b) Inheritance and benefit-sharing of traditional medical knowledge in ethnic areas of China, China Environmental Science Press, Beijing. Xue, D and Luo, G (2009) ‘On concepts and protection of traditional knowledge’, Biodiversity Science, 17 (2), 135–142. Yan, Y (2006) Research on legal protection of intellectual property of traditional knowledge, China Law Press, Beijing. Yang, M (2006) ‘The legal protection of traditional knowledge: the choice of mode and regime’, Studies in Law and Business, 1, 114–120.

9

Common pools in aquaculture Exploring patent law, ABS and sui generis options Morten Walløe Tvedt

Setting the scene: Developing ‘common pool thinking’ for ‘genetic resources’ and techniques in aquaculture innovation systems This chapter concerns developing ‘common pool thinking’ for biotechnology in the aquaculture sector. ‘Common pool’ is, in this context, understood as a legal system for creating a common resources base for research and development. Such a common pool must be discussed in the context of existing legal regimes of exclusivity for innovation in the aquaculture sector, as a number of existing norms are binding in their regulation of the matter. The task is to contribute to a better understanding of how law could promote marine-based innovation. The overall objective is to contribute to the understanding of how international law could contribute to the objectives of the Convention on Biological Diversity (CBD) (conservation, sustainable use, benefit sharing and innovation based on aquatic genetic resources). The task is to draw lessons from emerging legal systems pertaining to genetic resources and innovation in aquaculture while exploring their interaction with a common pool approach to explore whether and how this could be a useful model for law and fish farming and breeding. Common pools of genetic resources raise several questions, challenges, even problems or obstacles, regarding both the pool and the commonness of the resources, which need to be discussed if any hope of fruitfulness of approaching genetic resources and innovation from this perspective is to be had (at least in the author’s point of view). Two approaches are selected: a ‘de lege lata analysis’ where options for a common pool are discussed in the current legal situation. Common pools necessarily will be established in an already existing legal context. This is done to examine where in existing laws a common pool would touch on. The other methodological approach is a ‘de lege ferenda analysis’. This implies looking at options for future law and discussing some recent experiences from aquaculture in Norway as a concrete example. Some quite obvious questions need to be discussed and resolved for a common pool to become functional: the main concern is sought in having

Pooling in aquaculture 169 a closer look at the aquaculture industry in Norway. Thereinafter, the relevant legal systems to explore are identified. Third, there is a need to establish some clarity regarding the objects which might be included in the pool – that is, to what subject matters should pooling thoughts be applied? Since a common pool is a legal and/or factual construct, there is need for a mechanism to include objects in the pool; and as legal regimes already exist, there is a need to discuss and bring clarity to the relationship between the pool and existing legal systems pertaining to the same objects. The next issue is the need to discuss criteria for becoming a pool participant in order to clarify the conditions for accessing the pool; whether there will be any restrictions to the legal uses of material, ideas or other objects taken from the common pool. Lastly, discussion is needed about whether there will be any requirements to share benefits arising from the pool.

Norway’s aquaculture sector and the law The choice of the aquaculture sector as the branch to be explored is one of high strategic, economic and ecologic importance for Norway. Aquaculture in this context is mainly understood as fish breeding and farming. In terms of creating export revenues, the aquaculture sector is currently the largest export industry for Norway after oil and gas.1 The purpose of looking at aquaculture is diverse. First, it provides an example to illustrate and make visible the probable obstacles and constructive ways of organizing a common pool system for innovation; and second it contributes to thinking about the development of law pertaining to this important sector of Norway. Innovation in aquaculture in Norway is important from several perspectives. One is the reduction of production costs and ecological impact from increased fish farming along the coasts. Observing the rapid changes in market conditions for selling farmed salmon to export markets, it is easy to see that higher economic efficiency along with a better ecological approach would improve the competing conditions for the sector. Along with development of breeding stocks of salmon for farming in Norwegian waters, there is the export of breeding material to other countries, notably to Scotland, Chile and Canada. It is estimated that only 8.4 per cent of all farmed seafood globally use material improved by a breeding programme.2 Thus, there is huge potential in blue biotechnology. In Norway, the Marine Resources Act and the Nature Diversity Act target, respectively, ‘wild living’ marine biological resources and genetic material found in the ‘wilderness’. These relatively new acts do not concern or target new lines of fish or material which has been subject to research and development (Tvedt 2010b: chapter 4), and they illustrate that securing innovation in aquaculture suffers from lacunae in the law. National and global rules concerning wild as well as improved breeding material remain

170 Morten Walløe Tvedt blurred and not adequately adapted to the needs of Norwegian breeding companies (Tvedt 2010b: chapter 4). In contrast to the international drive towards stricter exclusive rights, findings from the aquaculture sector in Norway show that the patent system has not, until recently, been very actively used by Norwegian actors (Olesen et al. 2007). A new line of farmed salmon is hardly protectable by product patents, as a new breeding line of fish as such is unlikely to meet the criteria for patent protection. Innovation in the aquaculture sector can be protected, and there are notable examples, such as when a gene for rapid growth was coded into a transgenic salmon and a virus causing Pancreas Disease was patented. For genetically modified animals, patents are relevant. Also in the areas of feed and vaccines, there is a growing body of patents in the area of aquaculture. When it comes to vaccines, a recent case from the appeal court of Borgarting in Norway is a notable example that will be looked at in more depth later in this chapter. It has not been easy to predict how the sector may utilize already existing patent laws for protecting investments in breeding (Rosendal et al. 2006). The lack of legal systems to protect investments in breeding better lines of salmon suggests a need for discussing new ways of providing incentives to invest in breeding. Exploring alternative legal systems for breeders to capture the value-creation added by a breeding programme is at the centrepiece of such a discussion. A common characteristic for breeding programmes in aquaculture is that public funding is often necessary in the early phases of basic research. At the time of commercialization, questions concerning rights to genetic resources and related innovations financed by public funds arise. The choice of model for ownership will determine the flexibility and robustness of the breeding programme to survive. Private ownership is often coupled with a requirement for annual profit being provided to a financial investor. A privately owned breeding company will probably be vulnerable to a temporary fall in demand for its products. Since breeding is a continuous activity, there is a need for stability in investments and access to capital. A breeding company may, therefore, be exposed to a fall in demand and lack of access to capital, which can set the progress in breeding results back or even lead to closure of the programme. These observations regarding the patent system and need for stable ownership and access to funding raise more fundamental issues regarding private–public partnerships and the need for balancing the rights to the publicly funded research versus the rights to commercialize the end product. These aspects of innovation, breeding and law are all core aspects for discussing common pooling in aquaculture. Breeding programmes could take more account of national export markets when deciding their business strategy. For the Norwegian salmon breeding companies, a significant volume is exported from Norway. A breeding line of salmon requires large investments and costs for its

Pooling in aquaculture 171 maintenance, while the product has the potential to self-reproduce and thus be easy to copy illegally. These two characteristics of breeding programmes entail a strong need for an intellectual property right form of protection. Currently, this export happens based on private law agreements. If sold to another country, a risk of copying and illegal freeriding in investments may exist. Against this, the aquaculture breeding could also benefit from a globally recognized breeders’ right. It is not obvious how such a sui generis system should work as the object for such a right; a fish breeding line would have to be defined and applied in law and practical breeding. From this perspective, opting for a common pool solution is a promising idea to explore in more depth.

A closer look at the core legal concepts A fruitful method is to look at the theoretical concepts explored. As the introduction reveals, the two legal concepts, sui generis systems and common pools, are the centrepieces of the theoretical approach in this analysis. Sui generis means ‘in itself’ and is often connected to a system for protecting intellectual property objects by a particular system developed for a particular sector. Database protection is one type of object which is protected by a sui generis system for allocating property to the database as such (see Chapter 14). In the plant sector, Article 27.3(b) of the Agreement on Trade-Related Intellectual Property Rights (TRIPS Agreement) requires World Trade Organization (WTO) member countries to establish a system for sui generis protection for plant varieties if the patent system is not available to plant varieties. In plant breeding, the various editions of the International Union for the Protection of New Plant Varieties (UPOV) Convention establish examples of sui generis systems for the protection of ‘plant varieties’. Beyond specially adapted sui generis systems for the plant sector, no globally recognized sui generis system has been established so far to promote innovation in other branches of biotechnology. The question of whether industries other than the plant sector could benefit from making a sui generis protection system available in order to spur innovation has been raised both for animal breeding (Hiemstra et al. 2006; Tvedt et al. 2007) and for aquaculture (Olesen et al. 2007; Rosendal et al. 2006). No clear proposals for how such sui generis system for these areas could be drafted have yet been put on the table. For a sui generis system to be relevant, it needs to develop a clear definition of the object which can be protected or to which the system can confer a right. The biology of fish and animals in combination with applied breeding techniques are different from those of the plant sector. This means that the concept plant variety is impossible to transfer or adapt to the biological reality of aquaculture or farm-animal breeding. So, the first task would be to define a protectable subject matter for fish breeders’ rights.

172 Morten Walløe Tvedt The common pool concept seemingly draws upon a long tradition of commons in legal and political philosophy.3 The idea of pooling resources implies that there is a resource which, in one way or another, is kept in a non-exclusive or partially exclusive manner, or not subject to ownership, among a more or less defined group of legal persons. Commons understood in a traditional manner and in this more novel manner embody different notions. The original commons has been associated with the state of nature before any resources were taken under an exclusive right, whereas commons as understood here rather targets the situation down the value chain. ‘Commons’ has rhetorical potential as it is a historical–philosophical concept. The latter is the most relevant to explore as traditional notions correspond less with the current situation. Against this background, this chapter serves a theoretical and conceptual purpose along with a practical and applied purpose. In the perspectives of the overall approach taken in the Common Pool Project, this chapter will address legislation on the user side of the balance and look at sui generis and open sources as legal tools and mechanisms for protection on the user side of an ABS-situation.

Which objects might be suitable for inclusion in a common pool? The first core issue is to develop an understanding of the criteria for inclusion of resources in the pool. In biotechnology, and more particularly in aquaculture, several types of objects are relevant for pooling to spur innovation. It is relevant to discuss pooling of ‘genetic resources’ as it is understood in the Convention on Biological Diversity (CBD) (Schei and Tvedt 2010), as in biotechnological innovation, genetic resources may be regarded as the raw material. Progress in aquaculture is also dependent on inventions and technology. Therefore, it is equally relevant to explore knowledge, technologies and inventions as objects to be included in a common pool. For both genetic resources and inventions, there are already legal regimes in place, the CBD and Nagoya Protocol (NP) respectively, and patent law applied to biotechnological inventions. As these legal regimes already establish rights to these objects, a common pool will touch on these two areas of law and consequentially require discussion. As to inclusion in a common pool, these two types of objects are marked differently. Pooling of wild-living breeding material or other genetic resources is regulated by resource management laws and rules, whereas the results of innovation, techniques and bred lines of fish are typically held under more privatized rights. The different legal regimes already governing these objects become one main difference for including these two types of objects into one pool. Before looking into these two areas of law, an existing legal system which sets up a system for pooling resources is explored.

Pooling in aquaculture 173 ITPGRFA as a common pool example In discussions of common pools and genetic resources, the multilateral system (MLS) of the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA) is given as an example of a common pool.4 The task here is not to duplicate the efforts of others in dealing with the MLS as a common pool, but only to use the ITPGRFA as a pattern from which to draw some lessons for the topics dealt with here. The ITPGRFA defines quite specifically and in detail the objects included in that common pool: to be eligible for the pool, it must concern ‘plant genetic resources’. This basic and apparently comprehensive criterion is limited by two specific criteria: first, that only plant genetic resources belonging to food and feed species listed in Annex I are covered by the MLS as common pool. Thus, a number of species are excluded from the MLS. The second limiting criterion is that only PGRFA which are in the public domain and under the control of the Parties to the Treaty are included. This means that private collections of plant genetic resources (PGR), even of species listed in Annex I, fall outside the scope of that common pool. Samples and seeds saved on farms probably also fall outside the coverage of the MLS. A rather interesting observation is, therefore, that the common pool of plant genetic resources is narrowly and sharply defined by using the MLS for its management as the defining criteria. Notably, no inventions or technologies are included in this common pool system of the MLS. The treaty establishes a light obligation on member countries to encourage private collections to include their accessions into the multilateral system. This, however, rather takes the form of being an encouragement to include accessions rather than establishing a binding obligation, as it is almost impossible to enforce compliance with this soft rule by legal means. The basic underlying incentive for countries to include their material into the MLS is that no country in the world is said to be self-sustaining in respect of PGR for plant breeding purposes. Thus, having access to the PGR from other countries is important for food security in any country. From the perspective of a private party, the incentive to include their material is less evident. For a local subsistence farmer or a small-scale breeder whose stock has adapted to the local climate and soil conditions for decades with good results, making the material available to everyone in a global MLS would entail sharing his/her resources with everyone, while not receiving any obvious or concrete benefits in return. If a governmental or international collector of genetic material requires samples from this farmer to be included in the national public domain collection, the activity of collecting will, per se, probably not include any compensation or economic remuneration for the decades of breeding undertaken by the farmer. Thus, no direct incentives are built into the MLS for single, local farmers, unless the collecting activity is not linked with a benefit-sharing

174 Morten Walløe Tvedt system. The collective system by the Fund under the MLS provides benefit sharing to specific projects through an evaluation by the governing body of the International Treaty (IT). There are no mechanisms in the ITPGRFA which would provide these custodians (farmer or local breeder) with the prospect of remuneration for the samples being included in this common pool, either at the point of time of collection or at a commercialization stage. Thus, as a pool, it encourages certain types of collections to be included. The object ‘genetic resource’ from aquaculture to be included in a pool Existing and emerging ABS rules and common pools for aquaculture When discussing common pools and aquaculture, a primary issue for discussion is whether the item to include in the pool is raw material for breeding. If the pool captures genetic resources as raw material in bioprospecting and for research and breeding, it will interface with the rules and norms regulating provider and user countries of genetic resources in Article 15 CBD and NP. A first very obvious observation would be that the principle of sovereign rights of countries to their genetic resources, including regulation of access and rights to genetic resources, apply to the decision of inclusion of aquatic genetic material into a pool. This principle would imply that only the country with sovereign rights to the relevant genetic material would have the competence to allow for resources to be poured into the pool. There are no rules in the CBD which could be interpreted so as to prevent countries from using their sovereign rights to all or particular types of genetic resources to decide on whether to include them in a common pool. There are, however, major challenges which need to be resolved before countries become willing to allow their genetic resources to slip into a common pool. One major issue would be to clarify what would be the incentive for them to contribute to such a common pool. For a participant to be incentivized to contribute to the pool, the idea must be that he/she also gets access to something which he/she did not have access to before. More accessions in agriculture in general have been interchanged than in aquaculture. Traditions for such exchange for agricultural breeding predate those of aquaculture. The incentive for countries to include PGR in the MLS are stronger than for aquatic genetic resources as the interdependence is stronger in the plant sector than in aquaculture. Incentives need to be developed to make it attractive for countries to join their aquatic genetic resources in a common pool. One issue which can create incentives is the regulation of conditions for appropriating from the common pool. If inclusion of resources in the pool would secure access to other resources and research tools, that could create incentives for the pooling of aquatic genetic resources. The elements of the rules

Pooling in aquaculture 175 governing a common pool (as discussed in the following sections) need to be developed in a manner so that incentives for countries are created. The NP is supposed to implement the system of ABS under the CBD in a more certain manner. If, in the future, the NP fails to provide benefit sharing according to its intentions, a common pooling in which all users contribute something and also draw benefits could arise as a prosperous alternative. If the CBD and NP achieve a better impact on the three objectives then the common pool idea will probably be in a weaker position when it comes to incentives. One preliminary observation is therefore that a common pool needs to be attractive for right holders to include resources in the pool. Whether it would be attractive for Norway as a providing country to include genetic material will depend on how the pool is governed. Ultimately, it will become a question of political considerations whether to share genetic resources under sovereign rights in such a pool. An observation of one argument here is that Norway holds a selection of the best-kept wild salmon stocks with genotypical and phenotypical characteristics endemic to Norway. This biological fact considered in the light of the current legal situation suggests that the gain for Norway from accepting a system for a common pool of salmon genetic resources is not very strong, especially if the pool is limited to genetic resources. The potential commercial benefit herein is an argument in the direction of not including aquaculture genetic material in a global common pool for aquaculture. The whole setup for securing the interests of the Norwegian breeding industry will be important when considering whether sovereign rights will be used to encourage contribution to the common pool. Therefore, the legal and institutional set-up will be important for creating incentives. Existing patent law and common pools International patent law relevant for innovation in the aquaculture sector International and regional patent law sets a general and comprehensive body of regulation. It is fair to say that the level of detail and specific rules under the patent system form a more consistent and enforceable legal system than access laws based on the principles and ideas of the CBD. The core of the patent system is that a patent is granted according to each national legal system. In Europe, the European Patent Organisation (EPO) receives applications and grants patents with direct legal effect in national jurisdiction of all its 35 member states. The recent decision by the EU to establish a Community patent will continue a process of supranational legal developments of property law. Patent law is general in scope and is not concerned with particular areas of innovation. At the European regional level, the EU Directive on biotechnological inventions (EC/98/44) establishes special rules for biotech innovation but does not

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establish any particular rules for marine-based innovation. The TRIPS Agreement under the WTO and several treaties administered by the World Intellectual Property Organization (WIPO) also have no particular view on aquaculture. The explanation for the absence of detailed rules in this area might indicate that, until now, no particular need for such amendments has been identified as important to promote innovation in the field. There are contemporary anti-commons tendencies in international patent law (Tvedt 2007; Tvedt 2010a). One example is the conclusion of the Anti-Counterfeiting Agreement (ACTA). The negotiations leading to this treaty were held in a rather small group of countries. The Agreement aims to take enforcement of intellectual property rights in general to a stricter level.5 The future of ACTA is, however, uncertain after a large majority in the EU Parliament voted against its inclusion in EU law. There are also discussions regarding harmonization of the considerations for granting patents among the three major patent offices: the European Patent Organisation, the US Patent and Trademark Office and the Japan Patent Office.6 Sharing information about considerations of whether the patent criteria are met or not is one of the few topics on which developing and developed countries agree that more harmonization will benefit the whole system.7 Despite legally binding steps being taken on an international level to tie the large patent systems closer to each other, each patent is still granted according to the discretion of the national or regional patent system (subject to binding obligations in regional and international treaties). .

An existing patent and a common pool: discretion of the patentee A patent confers a right to the object described in the patent claims. Since a patent creates a right to an invention, there is a need for the use of language to establish and describe the object of the right. When granted, the patent holder has the exclusive right to the following acts: (a) where the subject matter of a patent is a product, to prevent third parties, not having the owner’s consent, from the acts of: making, using, offering for sale, selling, or importing for these purposes that product; (b) where the subject matter of a patent is a process, to prevent third parties, not having the owner’s consent, from the act of using the process, and from the acts of: using, offering for sale, selling, or importing for these purposes at least the product obtained directly by that process. (TRIPS Agreement Article 28 (emphasis added)) Thus, for existing inventions, it is the discretion of the patent holder whether to include the object described in the patent claims in a common

Pooling in aquaculture 177 pool or not. Therefore, the incentives for a patent holder to include any invention in a common pool need to be discussed and clarified. One could discuss another approach than enforcing patent rights: that the inventor decides to include his/her invention in a common pool rather than striving to get and maintain an exclusive right. It might be difficult to create sufficiently strong incentives for such an inclusion in the system. In corporate law, existing incentives and structures encourage companies to aim for exclusivity rather than sharing. Even obligations under corporate legislation may establish obstacles for them to take a decision to share benefits. In both these situations (before and after a patent has been granted), there is a need to discuss incentives for a right holder to dispose of the right by giving open access to their inventions in an open system. The holder of an exclusive right must consider it more favourable to include his/her objects in such a common pool. Such incentives could be made by recognizing that the totality of patents in a field hinders rather than promotes innovation. Another rationale could be that a company would only get access to certain interesting objects by becoming a member of the pool. This would require there to be interesting goods already available in the pool. One such asset could be the raw material for breeding – the genetic material. In this scenario, countries could probably use their sovereign rights to create incentives for companies to become members of a common pool. The relationship between incentives to develop new inventions in the aquaculture sector and patent law Patent law as an institution is established to promote and spur innovation. This assumed core effect has a limitation which is not very often fully articulated: patent law creates incentives only as strong as the willingness to pay a monopoly price in a market for the said product.8 Until now, it has not been comprehensive practice to apply for patents in the aquaculture sector (Rosendal et al. 2006; Olesen et al. 2007). The types of invention relevant to aquaculture may perhaps explain this: a new line of salmon is not really protectable subject matter. For innovations that are not easily protected by a patent, a common pool system would probably be more promising than for innovations that are easily protected under the patent system. One example of a patent is a transgenic salmon where recombinant techniques were used to increase the speed of growth of the salmon. This patent concerns a breeding technique which, according to the standardized rule in Article 28 of the TRIPS Agreement, gives an indirect, exclusive right to the outcome of applying that patented technique, which means all proceeding generations of this GM salmon containing the patented gene. A second example of an ‘invention’ in aquaculture is the ‘Pancreas Disease Virus’ patent which causes a disease in salmon. That patent was

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granted to Irish researchers for a deposited virus strain which, when injected in Atlantic salmon, develops Pancreas Disease (PD). The patent targets the virus itself and vaccines developed on the basis of the isolated virus. In Norway, Intervet (a company in the Merck corporate structure) holds the right to use this virus as a patented invention. Claim 1 of the patent reads: ‘... said virus is the virus strain deposited [...] or closely related strains which share similar genotypic and/or phenotypic characteristics to said deposited virus strain ...’ (emphasis added).9 This claim gives product patent protection to the deposited virus strain which is also described in the enabling disclosure. But the object is more widely defined: it also attempts to cover closely related strains, defined either by genotypic and/ or by phenotypic similarities to the original. Later on, a Norwegian vaccine, based on a virus strain found in Norway by researchers with affiliation to the University of Bergen (Hodneland et al. 2005), was developed by the Norwegian company Pharmaq. The patent holder (Intervet) won in court. The academic finding published in 2005 was interpreted to be under the scope of the patent. Thus, what was considered as a novel academic finding when they published it in a peer review journal was, in patent law terms, considered to be already invented and under the exclusive right of another. The Norwegian company Pharmaq was ordered to destroy three million doses of the vaccine which had already been produced and were in stock. At the time of writing, the outbreak of the disease would, however, require these vaccines to be used on production sites for farming salmon. Intervet pursues its patent by rejecting a voluntary licence to Pharmaq, challenges any compulsory licensing and is suing them to stop production of the Norwegian vaccine. Looking at these efforts, the willingness of Intervet to pursue this case by legal means is high. Similarly, the chances of them wanting to include their invention in a common pool is non-existent. Interestingly enough, they advertise the vaccine as the only one against PD on the market,10 which is true as they have an exclusive right to prevent other existing vaccines from entering the market. In these situations, when an invention meets the criteria for being patentable subject matter, the patent holder is in a position to use the legal system to establish exclusive rights and enforce them upon potential users. A viable common pool has to include incentives for patent holders to be willing to include their protected inventions in the system. Only inventions made and still owned by the public sector will be eligible, at the discretion of governments, for inclusion in a common pool. Governments in countries where governmental inventions are patent protected will typically have policies and rules for the commercialization of such inventions and patents on them. States may have the motivation to include material in a common pool, as this could make it more available and thus trigger more innovation on the material. These situations illustrate the lack of incentives for private companies to leave their

Pooling in aquaculture 179 innovations in a common pool. Thus, the discretion to include raw material genetic resources and inventions based on genetic resources in a common pool is different. In sectors where either the willingness to pay or the chance of actually controlling the market for particular inventions is low or absent, it becomes particularly interesting to search for other incentive-creating mechanisms and legal systems which can provide for useful new inventions and sufficient investment in the sector. Conclusion Unlike inclusion in the common pool of wild and unrefined genetic resources, governments have very limited competence to decide whether to include inventions and knowledge in a common pool. There are disincentives for a patent holder to include their property in such a common pool as it is in the financial interest of the holder of an exclusive right to maintain and care for this legal position. For these objects, a quite strong system for creating incentives to include inventions in a common pool will be required. In the following sections on sui generis and open source systems, this question of creating incentives is further discussed. This preliminary discussion of common pooling shows two lessons that can be learned: the first observation regarding the objects to be pooled is that there might be someone who has a right to the relevant objects, which could then be used to decide whether the objects are to be included in the pool. Thus, common pooling will be dependent on pre-existing rights and the use of discretion to transfer them by any kind of consent into the common pool. A second observation is that the right holder, prior to the common pool, has some level of discretion about whether to include a said resource in the pool or not.

Regulating access to the pool Another question which a common pool for innovation needs to address and resolve is whether the pool will be open to all users or restricted or subject to criteria for access. There are different theoretical approaches to this issue. At one extreme, access to the pool can be completely open to everyone without any restrictions. At the other extreme is the establishment of a strict regime for entering the pool. A pool might be established with a system by which membership is required in order to access the resources in the pool. Between these two extremes there are a number of ways of regulating access to the pool with different degrees of openness. Returning to the parallel with ITPGRFA, everyone has the right to access the plant genetic resources in the MLS. The ITPGRFA establishes two limiting criteria: first, the intent of the future use of the material

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accessed must be for food and agricultural purposes; other industrial, chemical or any other uses are not allowed. The second condition is that only users agreeing to be bound by the standard Material Transfer Agreement (SMTA) are given access. The SMTA for the MLS becomes binding for the receiver of material, setting a number of obligations on the pool participants but only regarding the resources within the pool. The receiver is not obliged by the ITPGRFA to share the results from his use of resources from the pool with the pool or with the other pool participants in any way. Pool participants One fundamental question is whether to regulate the entities which will have the right to access the pool of resources. The pool could be made open for the participation of everyone, or it could have criteria for access. It could also be established that in order to be allowed access to the pool, prior acceptance of certain obligations is mandatory. This criterion could be used to allow both entry to the pool and use of the material in the pool. The criteria for entities eligible for becoming pool participants can be assumed to be an important issue when countries and other parties decide whether to contribute to the pool or not. International institutional structure for a common pool For the ITGPRFA, there is a Secretariat to take care of the administration and a Governing Body which makes the decisions. The Governing Body of the Treaty has also developed and established a surveillance system to control compliance and hear cases of non-compliance. An equally important institutional structure for the functionality of the common pool for PGR of food and agriculture is the existing genebank collections of PGR, in particular in the CGIAR centres holding large collections of plant genetic resources in trust. In the aquaculture sector there are no corresponding international executive, decision-making or practical ex situ conservation institutions in place. In 2011, the Commission on Genetic Resources for Food and Agriculture (CGRFA) adopted a work plan whereby ‘aquatic genetic resources’ is one agenda item. The work of the Food and Agriculture Organization of the United Nations (FAO) in this area has not yet had significant effects on aquaculture in Norway. The lack of both international collections and policy instruments keeps the prospect open for establishing new common pools. Building all these institutions from scratch, however, would be quite burdensome. If a common pooling system is to be based on private law agreements, there is a need to establish an organizing system for handling these rights and obligations, and to ensure that everything is proceeding according to the

Pooling in aquaculture 181 rules of the pool. Also, there is a need to develop ideas about whether a common pool in aquaculture should consist of physical genetic material or should be maintained in a distributed and/or a digital format. Conditions for having access to a pool in aquaculture A series of relevant criteria for access to the pool could be discussed. These conditions could be of either positive or negative character: access to the pool could, for example, be given if the user undertakes to share with the pool developments made with material and knowledge taken from the pool. A negative obligation could be that the user accessing the pool should refrain from any attempt to secure an exclusive right to objects and knowledge, or at least make such rights available for other pool participants. In both these situations, the criteria imposed or accepted when entering into the pool would be based on a contract or an acceptance of preset conditions. Thus the legal basis for the pool would be private law agreements. This is at the core of the regulation of a common pool as, on the one hand, pool participants individually aim for the broadest possible right to use the subject matter in the pool and, on the other hand, the community of pool participants have an interest in maintaining the commonness of the pool as widely as possible. Another issue for a common pool needing to be resolved is the extent to which access to the resources in the pool should be granted on a nonexclusive or exclusive basis (or rather the degree of exclusivity). Businesses will often desire exclusivity for the material on which they do research, whereas the whole idea of a common pool of resources is non-exclusivity and sharing. This implies some level of contradiction and a challenge to effective utilization of the common pool. Further, when resources are included in a common pool, the pool’s will to resolve and organize the resources somewhat precludes the introduction of severe exclusive rights. A closely connected issue is whether a use right includes a right to commercialize any results of the research conducted on material from the pool. If an open source system does not allow for businesses to secure intellectual property rights on new developments from knowledge and material used or taken from the pool, incentives to make effective use of the pool are somewhat limited. The manner in which this issue is resolved in the ITGRFA is that everyone has the right to use all the accessions in the pool (MLS) for food and agricultural purposes, but not for other purposes (SMTA Art. 6). Thus, the scope of activities allowed is positively limited for certain types of research for food and agriculture; while limited in a negative manner for chemical and pharmaceutical ends. Access to the MLS does not confer any exclusive use rights for accessions of the same material still in the pool. If a user receives material from the MLS, then Article 6.3 SMTA requires

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the material to be made available using the same SMTA. These rules establish a system seeking to keep the pool open for later use also by others. The ITPGRFA and the SMTA both establish rules which limit the discretion of the receiver to take out intellectual property rights on the material ‘in the form received’.11 Any attempts to keep resources available in a common pool will not only depend on the rules of the pool itself, but will be delimited by other rules establishing rights to the subject matter, such as patent law. When establishing a common pool, two main approaches to this matter are possible: either to develop the list of criteria beforehand, or to create mechanisms for deciding on this matter at a later stage. This latter approach would give the greatest flexibility to the pool; however, the uncertainty might act as a disincentive for pool participants to include their subject matters into a pool for which the criteria of appropriation are unclear. Defining the rules beforehand could make the pool more attractive to potential members. A pool could also draw on a combination of these two approaches by having a set of criteria at the point of establishing the pool but building an institutional structure and a set process for the modification, alteration and re-discussion of the criteria. This combined approach was applied to the SMTA under the ITGRFA, where a number of the issues were resolved in the Treaty and others were left outstanding, to be decided in the SMTA. The relationship between an established common pool and new patents The pool itself could require pool participants, through private law agreements, to undertake specific obligations. Interestingly, both plant variety rights and the patent system set a basic criterion for having a right that the invention and the plant variety have some novelty. To what extent these obligations will have any effect depends on the definition of novelty in these two legal systems. The extent to which these rules will be effective will depend on practice under these systems. The question of how, respectively, novelty and inventiveness function as criteria under the systems becomes the actual legal mechanism for maintaining the scope of the common pool. In patent law, the consideration of novelty is a technical comparison of two written sources: the patent claim and the body of published literature on the matter, called ‘prior art’ in patent terminology. Prior art is defined as everything which is already known before the patent application, but is defined in a somewhat narrower and more technical manner (Hope 2008: 162–163). A case from the Enlarged Board of Appeal under the European Patent Organisation (EPO) may shed some light on how ‘prior art’ will operate in respect to common pools. This case is clearly not binding beyond Europe, but is presented here to illustrate how ‘prior art’ has been interpreted. The European Patent Convention Article 54 (2) uses the term ‘everything

Pooling in aquaculture 183 made available to the public’. The question at stake in the Biogen case was whether the deposit of the gene in a gene bank could sufficiently be considered as ‘prior art’ and thus not meet the condition of novelty.12 The Enlarged Board of Appeal argued that the gene ‘…had not been made available to the public by this publication itself or through this publication from the gene bank’.13 The Enlarged Board of Appeal held that if there is a need for screening a gene bank, then the deposit in the gene bank does not constitute a part of the ‘prior art’.14 In that case, the DNA was ‘hidden in the multitude of clones of’ the gene bank, and was, therefore, not part of the ‘prior art’. The Enlarged Board of Appeal required a more comprehensive publication of the resources in a gene bank to be part of the ‘prior art’. The consequence of this is that a patent can be granted and establish one exclusive right to an object which the wording of the SMTA would not allow. Similar conflicts of overlapping rights might come up for a common pool in aquaculture and patented inventions. Typically, a common pool of viruses (such as the PD virus) would probably qualify for patent protection. The definition of what qualifies as ‘prior art’ and practice regarding the novelty requirement will determine whether a genetic resource in a common pool will meet the patent criteria or not. To draw a parallel to the MLS for plant genetic resources, according to Fowler et al., no inventory of all the alleles in the CGIAR centres exists (2004: 649). The public availability of biological or genetic material, including that made available by the CGIAR centres, does not guarantee lack of novelty; at least not for elements of the accessions obtained from the collections. For aquaculture, ‘prior art’ will depend to an even lower degree than the plant sector on written sources, as the body of literature on fish breeding is less than that recorded in the plant sector. This might entail a challenge for the items put into a common pool: if not described in a novelty-breaking manner, pooled resources are not automatically considered non-novel in patent law. This is a challenge for maintaining a common pool. Relationship between the rights of the pool and a later established exclusive right A legal question arises: if a right to an object which was taken out of the common pool is later patented or made subject to another type of rights, then which right will prevail? It would be a non-compliance situation in respect to the contractual obligation to this pool. A related question is whether the newly established right could be enforced. The situation here would be that there is one contractual obligation conflicting with a patent right. The patent system does not include any limitations for their enforcement in cases where there is a conflict with other private rights, such as contractual rights. It is quite probable that the patent right will

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prevail in such a conflicting situation, but there is so far no jurisprudence on this matter globally. The agreement establishing the common pool would benefit from a clear regulation of this situation. One way of establishing a negative incentive for a pool participant to attempt to remove objects from the commons would be to include a clause that patents in violation of the agreement would give all pool participants the right to a non-exclusive right to make use of the invention. This might prove more effective and promising for other pool participants, as the patent system does not recognize the breach of a contract – for example, with a common pool as a reason for revocation of the patent.

Benefit sharing from the pooled object For a common pool solution to become attractive, the conditions for contributing to the pool in return are of critical importance for creating incentives to join a pool. In the SMTA of the ITPGRFA there are benefitsharing clauses, but they do not impose severe obligations on users. Drawing some lessons from open source to develop a common pool for innovation in aquaculture The next real challenge in this picture is to come up with suggestions for principles and rules for how a common pool could design its benefitsharing scheme. Open source systems in software programming could lend this discussion some guidance. In these systems, the results from innovative activity by each user will be made available for the other pool participants on the same conditions as the material which was used from the common pool. The main idea is that the source code for the software is made open to others, to make use of it and add their contribution to it. The basic legal condition for open source is that the material is freely available; this principle also applies to products developed using techniques covered by open source regulations. A complicating factor for aquaculture here is that it is very expensive to develop good breeding material and very cheap to copy it. This requires a balance of rules which challenge well established truths, perhaps for both the ABS and the IPR/ patent communities (Rosendal et al. (2013)). Open source is a concept which was mostly developed in the software sector. The basic legal condition for open source is that the material is freely available; this principle also applies to products developed from techniques covered by open source regulations. This allows knowledgeable users to study the software, fix bugs and modify it according to needs and priorities. Software distributed in this fashion is often accompanied by a licence that specifies that any continued distribution must also make the source code available and allow for further changes and modifications. Open source licensing gave rise to development practices that differed

Pooling in aquaculture 185 from the way traditional software was developed. It is possible for a large number of users in different locations to collaborate on software development by sharing codes on the internet. The ‘open source’ concept spread to denote innovation practices that promote access to source material, whether it is source code, enabling technologies or genetic resources. Biological science differs from software development and source code. In software, copyright dominates, and the start-up cost for developing software is relatively low compared to biotechnology. Discussing open source for inventions from marine bioprospecting needs to create similar incentives to those created by patent law, taking innovative conditions for the sector particularly into account. Within the biological sciences, patents are the dominant type of intellectual property right. When discussing conditions or open source solutions connected to innovation in the aquaculture sector it is necessary to draw on the system of patent rights. For the export of breeding material from Norway to other countries farming salmon, the challenge is to maintain the right to the second and following generations of salmon. The first buyer of breeding material will typically be bound by a sales agreement. Contract law combined with the knowledge of who the buyer of the breeding material is are sufficient legal tools to solve the enforcement question. Making the protected invention as a whole available to other pool participants would make it difficult for the inventor to recoup his investment. Therefore, an alternative way of contributing back to a common pool could be explored. How to capture the relative contribution One critique of the patent system in the genetic resources sector is that the last innovator captures the economic value of previous contributors. The PD case is a prominent example, as before the patent was applied for a number of other researchers had invested in work related to finding the cause of the symptoms. Moreover, the patent covered academic findings from after the application date for the patent. The patent system is exposed for conferring the whole right to one person who was quick to apply for the patent, but who is not necessarily the developer of the best products. The real challenge for a sharing of benefits in a common pool is to calculate backwards from a new product how each contributor has contributed to the final product. These challenges raise ‘fairness’ questions in two perspectives in time. In this respect, determining the relative contribution of each pool participant as reflected in the new invention is a difficult task. It is a practical challenge to identify the actual contribution and very challenging to quantify different types of contribution to the new invention. Therefore, it is not easy to establish

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fairness for previous contributors so their previous work is recognized and conferred a clearer right. Principles for calculating relative contribution would need to be developed for a common pool to function. The fairness argument in a common pool also has a future perspective. On the one hand, contributors to the pool who also contribute to the new invention need to have access to the research results. On the other hand, the patent holder who has invested time and money needs to receive a fair share.

Would putting genetic heritage and patented innovations into a common pool spur innovation? From these analyses, I have observed a number of obstacles to the functional implementation of a common pool for aquatic genetic resources and for innovation relevant to the aquaculture sector. There is a lack of incentives for fish breeders to include their material in such a system. Existing international and domestic legal regulations of this subject represent a barrier to the establishment of a common pool of aquatic genetic resources and related inventions. The Norwegian aquaculture sector, mainly salmon breeders, has shown in two previous studies that breeders are not very keen on using exclusive rights to protect their inventions, whereas at the same time, breeders are afraid of private exclusive rights being established by others, creating legal or other barriers to their activities (Rosendal et al. 2006; Olesen et al. 2007). The attitude towards patents might change after the court case against the Norwegian company Pharmaq in 2011. The relationship between the existing system for appropriation of gene-based inventions and the rules securing the objects put into a common pool will probably be of interest. In a world with global competition where the worry of Norwegian breeders is how to secure their investments when exporting breeding material, this question becomes crucial to consider.

Conclusion This chapter has shown that it is not in the interest of Norway to exercise its sovereign rights to genetic resources according to the CBD by including salmon or other genetic resources into a common pool for food and agriculture. This is a finding relevant to the ongoing discussion about a new umbrella for ABS under the Commission on Genetic Resources for Food and Agriculture (CGRFA) in the FAO. For both salmon genetic resources and for the pathogen micro-organism causing PD, it would be in the interest of Norway to exercise its sovereign rights more intensively rather than secure the national production of fish-farmed food. In aquaculture, Norway does not depend on genetic material from other countries for increasing food production. The countries of origin for these

Pooling in aquaculture 187 salmon genetic resources are easily determined as they originate from specific river systems in Norway. In the CGRFA, patent issues are not allowed onto the agenda on the grounds that WIPO (the competent UN body for IPRs) is dealing with the matter. WIPO deals with patents in general, but is not very engaged in looking at the effects the patent system has on single areas of innovation, like aquaculture. This causes the application of the patent system to special areas of innovation never to be dealt with in international forums. This chapter has shown a clear lack of incentives for patent owners to include their property in a common pool. In the PD patent case, the very proactive or even aggressive manner in which Intervet, on behalf of its multinational owner, has enforced and defended its strict and broad patent rights, discloses a lack of willingness to share in a common pool system. This chapter also shows that for a country to be interested in including its genetic resources in a common pool, private patent owners would, simultaneously, also have to make their inventions available in a common pool – otherwise the balance would easily be shifted. It would not make sense if Norway gave open and free access to salmon pathogens or salmon genes if these resources were included in patented inventions that were enforced and hindered Norwegian parties from engaging in food production in aquaculture in Norway. Including merely genetic resources and not intellectual property rightprotected inventions in a common pool is therefore not a good idea. If a common pool will be of interest to aquaculture in Norway, both these main assets must be included in the pool. If the CGRFA were to establish an umbrella based on common pool thinking, patented inventions must be dealt with in the same system. Finally, how to develop a mechanism which calculates the relative contributions of different sources to a product is a difficult but important task in solving benefit-sharing questions in a common pool. There is a need for a common pool to cover a critical mass of genetic material and innovations for sharing at an early stage in order to incentivize others to join. Further, the institutional and legal set-up must be clearly in place so that a common pool can create the stability and predictability businesses are looking for when investing in research and development. On this point, one can expect that it will be quite challenging for a common pool to get beyond a critical mass of available assets. If a pool were to get beyond this challenge, then the incentives would be strong in the direction of attracting innovations to the pool. But starting to achieve such a critical mass by including only genetic resources and not inventions will result in further privatization of the current common pool resources, which will probably lead to a new wave of privatization in aquaculture rather than promoting global common goods.

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Notes 1 2 3 4 5

6 7 8

9 10 11 12 13 14

According to Norway’s official statistics (http://www.ssb.no/emner/09/05/ muh/tab-2012-06-15-02.html, viewed 15 June 2012). Paper presented by Ingrid Olesen, ‘Why is less than 10 per cent of aquaculture production based on genetically improved stock in Las Vegas?’, 21 March 2012. The idea was proposed by Locke (1960), and further developed by e.g. Drahos (1996). See Chapters 7, 10 and 17. See Intellectual Property Watch, 8 September 2010, ‘Treaty negotiators turn to “ACTA Lite” in hopes of closure’, http://www.ip-watch.org, viewed 17 January 2013. This agreement was negotiated by a small group of invited countries with the purpose of agreeing principles for enforcement of patents much stronger than the rules already provided by the TRIPS Agreement. For more information about this semi-informal cooperation, see http://www. trilateral.net, viewed 24 January 2013. This is a core topic for discussion at the Standing Committee on Law of the Patents, SCP, http://www.wipo.int/meetings/en/details.jsp?meeting_id=25016, viewed 17 January 2013. Several challenges arise for creating willingness to pay on a market. These include practical and legal challenges to surveillance and enforcing an exclusive right to the said subject matter. Willingness to pay on a particular market is also not easily constructed as a concept. Claim 1 in European patent EP 0,712,926 B1 and Norwegian patent no. 317,547. http://www.teamaquatic.no/produkter-tjenester.aspx, viewed 7 April 2012. ITPGRFA Article 12.3(d) and more specifically in SMTA Article 6.2 adding ‘its genetic parts or components’ to what cannot be claimed under IPR protection. Biogen v. Boehringer Ingelheim Pharma AG, [1989] T 0301/87, Board of Appeal, EPO, 16 February 1989, paragraph 3.3.2. Ibid., paragraph 5.2. Ibid., paragraph 5.4.

References Agreement on Trade-Related Aspects of Intellectual Property (Annex 1C of the Agreement establishing the World Trade Organization) [TRIPS Agreement], WTO, 15 April 1994. Biogen v. Boehringer Ingelheim Pharma AG, [1989] T 0301/87, Board of Appeal, EPO, 16 February 1989. Drahos, P (1996) A philosophy of intellectual property, Aldershot, Ashgate. European Patent Convention [EPC], 5 October 1973, as amended on 17 December 1991, 21 December 1978, 13 December 1994, 20 October 1995, 5 December 1996, 10 December 1998, 27 October 2005 and 29 November 2000. Fowler, C, Hawtin G, Ortiz, R, Iwanaga, M and Engels J (2004) ‘The question of derivatives: promoting use and ensuring availability of non-proprietary plant genetic resources’, Journal of World Intellectual Property, 7 (5), 641–663. Havressurslova/ Marine Resources Act, Norway, LOV-2008-06-06-37. Hiemstra, SJ, Drucker, AG, Tvedt, MW, Louwaars, NP, Oldenbroek, JK, Awgichew, K, Kebede, SA, Bhat, PN and da Silva Mariante, A (2006) Exchange, use and conservation of animal genetic resources, CGN report no. 2006/06, Centre for Genetic Resources, Wageningen, Netherlands.

Pooling in aquaculture 189 Hodneland, K, Bratland, A, Christie, KE, Endresen, C and Nylund, A (2005) ‘New subtype of salmonid alphavirus (SAV), Togaviridae, from Atlantic salmon Salmo salar and rainbow trout Oncorhynchus mykiss in Norway’, Dis Aquat Organ 67 (1–2), 181. Hope, J (2008) Biobazaar: the open source revolution and biotechnology, Harvard University Press, Cambridge, MA. International Convention for the Protection of New Varieties of Plants 1991 [UPOV-1991], UPOV, 2 December 1961, UPOV/INF/6/1, as amended on 10 November 1972, 23 October 1978 and 19 March 1991. International Treaty on Plant Genetic Resources for Food and Agriculture [ITPGRFA], Food and Agriculture Organization of the United Nations, 3 November 2001, 2400 UNTS 303, entered into force 29 June 2004. Locke, J (1960) Two treatises of government, Laslett, P (ed.), Cambridge University Press, Cambridge. Naturmangfoldloven/ Nature Diversity Act, Norway, LOV-2009-06-19-100. Olesen, I (2012) ‘Why is less than 10 per cent of aquaculture production based on genetically improved stock in Las Vegas?’, Paper presented by Ingrid Olesen, 21 March 2012. Olesen, I, Rosendal, K, Tvedt, MW, Bryde, M and Bentsen, HB (2007) ‘Access to and protection of aquaculture genetic resources: structures and strategies in Norwegian aquaculture’, Aquaculture, 272, Supplement 1, S47–S61. Rosendal, K, Olesen, I, Bentsen, HB, Tvedt, MW and Bryde, M (2006) ‘Access to and legal protection of aquaculture genetic resources: Norwegian perspectives’, Journal of World Intellectual Property, 9, (4), 392–412. Rosendal, K, Olesen, I and Tvedt, MW (2013) ‘ABS governance in the aquaculture sector’, in Oberthür, S and Rosendal, K (eds), Global governance of genetic resources. Access and benefit-sharing after the Nagoya Protocol, Routledge, Abingdon. Schei, PJ and Tvedt, MW (2010) ‘Genetic resources’ in the CBD: the wording, the past, the present and the future’, FNI Report, no. 4/2010, Fridtjof Nansens Institutt, Lysaker. Standard Material Transfer Agreement [SMTA], International Treaty for Plant Genetic Resources for Food and Agriculture, came into force 16 June 2006. Tvedt, MW (2007) ‘The path to one universal patent’, Journal of Environmental Policy and Law, 37 (4), 297–305. Tvedt, MW (2010) ‘One worldwide patent system: what’s in it for developing countries?’, Third World Quarterly, 31 (2), 277–293. Tvedt, MW (2010b) Norsk genressursrett: rettslige betingelser for innovasjon innenfor bioog genteknologi, Cappelen akademisk forlag, Oslo. Tvedt, MW and Young, TR (2007) ‘Beyond access: exploring implementation of the fair and equitable sharing commitment in the CBD’, IUCN environmental policy and law paper no. 67/2, IUCN, Gland, Switzerland. Tvedt, MW, Hiemstra SJ, Drucker AG, Louwaars, NP and Oldenbroek, K. (2007) ‘Legal aspects of exchange, use and conservation of farm animal genetic resources’, FNI Report, no. 1/2007, Fridtjof Nansens Institutt, Lysaker.

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Part III

Transnational approaches

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10 Practices of exchanging and utilizing genetic resources for food and agriculture and the access and benefitsharing regime Sélim Louafi and Marie Schloen Introduction As genetic resources for food and agriculture (GRFA) fall within the scope of the Convention on Biological Diversity (CBD), its Nagoya Protocol and most regional and national biodiversity laws and arrangements, the access and benefit-sharing (ABS) provisions of these instruments have a direct impact on the practices of use and exchange of genetic resources in the food and agriculture sector. Whereas the special nature of GRFA has been widely acknowledged, most existing ABS laws and arrangements do not foresee special consideration for GRFA. This implies a risk of regulating their use and exchange without paying due attention to their specific characteristics and requirements. In Article 8, the Nagoya Protocol, which was adopted in October 2010, requires each party to ‘consider the importance of genetic resources for food and agriculture and their special role for food security’ while developing and implementing its access and benefit-sharing legislation or regulatory requirements. Therefore, it recognizes the special nature of agricultural biodiversity, its distinctive features and problems needing distinctive solutions. Further, Article 4 opens the way for parties to develop and implement specialized access and benefit-sharing agreements/ instruments and requires due regard to be paid to useful and ongoing work and practices under international instruments and relevant international organizations, provided such (international) instruments and work and practices are supportive of, and do not run counter to, the objectives of the CBD and the Protocol. Thus, the adoption of the Nagoya Protocol both increases the need and opens new opportunities to identify the specific characteristics of GRFA, assess the potential impact of different ABS measures on their use and exchange, and explore existing and develop new options for implementing ABS in the food and agriculture sector. Building upon the work undertaken by the FAO Commission on Genetic Resources for Food and Agriculture (the Commission) on ABS for

194 Sélim Louafi and Marie Schloen GRFA since 2007, a Multi-Stakeholder Expert Dialogue on Access and Benefit-Sharing for Genetic Resources for Food and Agriculture was initiated during the first semester of 2011. These dialogues were composed of around 40 participants from different regions of the world. The experts represented, in more or less equal numbers, the six different subsectors (animal, aquatic, forest, microbial and plant genetic resources, and genetic resources relevant for biological control) of the food and agriculture sector. They work in the context of developing and developed countries, and in public and private entities involved in the conservation, research and development of GRFA. In addition, some of the experts have a legal background and are involved in the international ABS debate.1 The MultiStakeholder Expert Dialogue met in two workshops held from 25 to 26 January 2011 in Brussels, Belgium and from 31 March to 1 April 2011 in Montpellier, France. The first workshop was mainly focused on the discussion of current practices of use and exchange of genetic resources in the different subsectors of food and agriculture and on the identification of specific features of GRFA that are common to many or most GRFA and may have an influence on the suitability of different ABS measures. The workshop also initiated a discussion of possible ABS scenarios and parameters to assess the potential impact of ABS measures on the use and exchange of GRFA. This impact assessment was then the main focus of the second workshop of the Multi-Stakeholder Expert Dialogue. Based on the conclusions of the impact assessment and the presentation of some examples of existing initiatives and innovative approaches for ABS, the second workshop also discussed possible principles and approaches for addressing ABS in the food and agriculture sector. This chapter is a re-edited version of the report issued following the Dialogue and published by the FAO CGRFA as a background study. It is adapted to the main theme of this book by highlighting the pool dimension of various GRFA exchange patterns and the way they could be adapted to ABS requirements of the Nagoya Protocol. The first part of this chapter provides an overview of the use and exchange of genetic resources in the different subsectors of food and agriculture, including animal, aquatic, forest, plant and microbial genetic resources for food and agriculture, and genetic resources relevant for biological control. The second part of the chapter discusses the potential impact that ABS measures may have on the use and exchange of GRFA. Finally, and based upon the impact assessment, the conclusion of the chapter outlines some general principles and possible approaches for addressing ABS in the food and agriculture sector.

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Part 1: Overview of current practices in the use and exchange of genetic resources for food and agriculture in the main subsectors of food and agriculture The use and exchange of animal genetic resources for food and agriculture (AnGR) Animal genetic resources for food and agriculture (AnGR) have been used and exchanged by humans for the last several thousand years. Long processes of domestication and selective breeding have considerably altered the genotypic and phenotypic characteristics of the species and populations involved, and currently used AnGR are characterized by long genetic distances from their wild ancestors. In fact, for many domesticated livestock species no wild relatives exist, as they have become extinct, and for others wild relatives are very rare. Because of the relatively low reproduction rates and long generation intervals of many livestock species, animal breeding often relies on continuous genetic improvement over long timeframes, and on the inclusion of parts of the production population in the breeding process in order to achieve sufficiently large, effective population sizes and obtain satisfactory selection gains. This factor limits the potential for centralizing the production of breeding stocks. AnGR are used by a wide range of stakeholders and the level of centralization and specialization of breeding activities is quite variable within the sector. Traditionally, the management of AnGR and breeding lies in the hands of livestock keepers who combine breeding and production functions within the same populations. This can be done on a fairly local scale, selecting the animals to form the next generation from locally available herds and flocks. It can also be done on a regional or national scale by forming a common breeding population through breeding associations or herdbook societies. In recent decades, a highly specialized breeding sector has developed for some livestock species in some regions of the world. In the poultry sector in particular, relatively high reproduction rates have enabled a large-scale breeding industry to centralize genetic improvement and the supply of improved animals to producers. Similar structures are emerging in the pig sector, although to a lesser extent (FAO 2009). Historically, AnGR have been widely exchanged throughout the world and many of the most commonly used breeds are of mixed ancestry. Livestock keepers and breeders in many parts of the world have contributed to the development of these breeds, and today livestock production in most regions depends on AnGR that originated or were developed elsewhere. Currently, major exchanges of germplasm in the most commercially relevant species take place between developed countries or from developed to developing countries. Genetic material of

196 Sélim Louafi and Marie Schloen some breeds adapted to tropical and subtropical environmental conditions is also exchanged among developing countries. In contrast to the more commercially relevant breeds that are widely exchanged, many breeds are used locally and are not strongly involved in international exchange. This may change in the future, as many of the traits needed to respond to the effects of climate change may be found in locally adapted breeds. Climate change is not only likely to increase the exchange of AnGR overall, but could possibly also lead to a more important flow of germplasm from developing to developed countries (FAO 2009). The use and exchange of aquatic genetic resources for food and agriculture (AqGR) Aquaculture is a relatively new and fast-growing activity. Aquaculture products currently account for nearly 50 per cent of seafood consumed globally. The sector is characterized by a high number of stakeholders along the supply chain, from breed improvement to the sale of live fish. The players range from smallholder producers to large-scale commercial companies. Genetic improvement of domesticated species remains a nascent activity: it has been estimated that five to ten per cent of all aquaculture production is derived from systematic breeding programmes (Gjedrem 2005: 364). It is, however, expected that this percentage will increase over time as genetic improvement is facilitated by the high fecundity and relatively short life cycles of many aquatic species, which allow for intensive and rapid selection (Bartley et al. 2009). Aquaculture is the main reason for the deliberate movement of aquatic species to areas outside their native ranges, and farmed species have been moved extensively throughout the world. The exchange of AqGR for introduction purposes has taken place in many different directions between the northern and southern hemispheres (Gjedrem 2005: 364). The practices and modalities of exchange vary according to the level of domestication of the respective species and the degree of professionalization of the sector (i.e. particularly, how production is divided into broodstock development, multipliers/hatcheries and growout). Generally speaking, these exchanges remain regulated by classic commercial practices, meaning that AqGR are sold without further conditions attached. Sometimes, they may even be freely exchanged between entrepreneurs, even internationally. Two general developments are leading to more formalized exchange practices: •

Government involvement in regulating the exchange of AqGR (e.g. through approval procedures) is becoming more frequent. In instances where the development of the aquaculture sector is primarily based on exotic species, and management of the breeding populations

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is poor (resulting in inbreeding and loss of genetic diversity), genetic replenishment of the stocks is often required to sustain production levels. However, a general reluctance among original suppliers to provide stocks for replenishment is increasingly prevalent. Private law contracts between seller (breeding company) and buyer (e.g. multiplier or producer) restricting use for further breeding are becoming more frequent. Because most genetically improved aquatic species are fertile and can be reproduced easily, contractual arrangements attempt to limit the scope for unauthorized exchange of AqGR.

The importance of international exchange of AqGR is expected to increase in the future, due to a growing number of species being domesticated and taken into production, and due to the need for exotic genetic material to respond to the effects of climate change. The use and exchange of forest genetic resources for food and agriculture (FGR) One of the main uses of forest genetic resources (FGR) is direct use as reproductive material (in the form of seeds, cuttings and other propagating parts of a tree) for the regeneration of natural forests on the one hand, and for the establishment of plantations and agroforests on the other. The extent to which FGR are used in systematic exploration and breeding programmes varies heavily among different tree species. For several fast-growing tree species used for industrial and smallholder planting, systematic exploration and improvement started some 50 years ago and has mainly focused on the most common plantation tree species, such as acacias, eucalypts and pines. For various temperate and boreal tree species, exploration and assessment efforts started more than 200 years ago, though more systematic improvement programmes were mostly initiated during the course of the twentieth century (Koskela et al. 2009). For the majority of other species, improvement efforts still remain limited and are mostly restricted to provenance trials and the selection of seed stands. In general, forest tree breeding is determined by long generation intervals and breeding cycles and most species are still within the first generations of genetic improvement. However, genetic gains per generation can be quite substantial due to the fact that many species are virtually wild, and diversity and selection opportunity is very high. Additionally, some species, such as tropical eucalypts, acacias and some pines are progressing relatively rapidly because of shorter generation intervals (typically less than ten years) and early selection techniques. While the movement of FGR around the world has a long history and the proportion of exotic forest reproductive material used for plantation and afforestation is quite high, considerable differences exist between species regarding their involvement in international exchange of

198 Sélim Louafi and Marie Schloen germplasm and the extent to which they have spread outside their natural distribution ranges. For example, several fast-growing plantation species, such as acacias, pines and eucalypts, have been moved extensively throughout the world and are cultivated nowadays far beyond their natural distribution ranges. Moreover, some high-value, tropical, speciality timber species such as mahogany, Spanish cedar and teak are grown as exotics (Koskela et al. 2009). Although the exchange of some species, such as agroforestry tree species, may have taken place on a smaller scale, their distribution among countries beyond their native ranges has played an important role in the development of the sector. However, for many species, exchange of genetic material has been limited to date and mainly takes place on a regional level or between countries sharing the same climatic conditions. Various species are also used largely within their natural habitats in native forests and are only very occasionally exchanged, for example for specific research purposes. The actual flow of forest reproductive material is not determined only by the use of exotic species. For example, some countries are self-sufficient with respect to the supply of reproductive material of exotic species that were introduced earlier, because the historical movement of germplasm of the species has led to the establishment of a sufficiently broad genepool within the new country. In contrast, countries may also depend on the import of reproductive material of their own native tree species from neighbouring countries. However, the demand for seed or other reproductive material is generally higher for exotic species. For the future, it is expected that the movement of forest reproductive material will become even more important, mainly due to the challenges of climate change. Forest reproductive material is mostly exchanged on a commercial basis. In some cases, the movement of genetic material is based on bilateral agreements, such as material transfer agreements (MTAs). Even though intellectual property rights are not used in the FGR sector, some restrictions on the further use of the material may still apply. For example, acacia and eucalypt clones supplied as micropropagated plantlets in tissue culture by some tree breeding agencies may be sold outright for unrestricted use by the purchaser or, in other cases, licensed for propagation with royalties payable on a permanent or per-hectare basis (Koskela et al. 2009). The use and exchange of plant genetic resources for food and agriculture Plant genetic resources for food and agriculture (PGRFA) have been used and exchanged since the beginnings of agriculture, some 10,000 years ago. Farmers and farming communities have planted, selected and exchanged seeds and vegetative propagating material, and a combination of natural and artificial selection has domesticated plant species and

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adapted them to the changing needs of farming and consumption. Migration, trade and colonization spread many species beyond their regions of origin, which spurred further selective pressures. Since the midnineteenth century, professional seed suppliers, followed by specialized plant breeders and biotechnologists, have developed advanced methods for selecting PGR at the phenotypic, genotypic and molecular levels to further shape crops and contribute to advanced agricultural systems and the production and supply of agricultural products with distinctive characteristics. The sector using PGR for breeding purposes is quite diverse and its organization is highly dependent on the crops bred and the geographic area and type of user group targeted. Large private corporations increasingly dominate the commercial seed market for some of the major and high-value crops, such as maize and major vegetables. Medium- and smaller-sized breeding companies continue to operate in smaller seed markets for commercially less attractive crops, such as some selfpollinating staple crops. Public-sector institutions at national and international levels continue to play an important role in breeding and variety development both for crops not served sufficiently by the private sector and for marginal environments and resource-poor farmers who are not likely to be reached by the commercial sector. At the level of research for breeding, including rather fundamental research as well as prebreeding, both large and small biotechnology companies, sometimes integrated with plant breeding and seed production, and universities are the main players. Other users of PGR include farmer groups and civil society organizations supporting them. They may contribute to the reintroduction of PGR from genebanks into farming systems, sometimes combined with participatory plant breeding or participatory variety selection activities involving both farmers and trained breeders. Different types of PGR may be used in plant breeding and variety development. The development of new varieties is usually based upon the use of advanced genetic material, as it is generally a costly and timeconsuming process to bring less advanced material to the same performance levels. However, old varieties, landraces and wild crop relatives may be used to introduce particular traits into breeding populations. The genetic diversity contained in landraces and traditional varieties may also be used for base-broadening activities and for the development of varieties adapted to less favourable environmental conditions and low-input production systems. Historically, crops and PGR have been widely exchanged throughout the world, and many people in many different places have contributed to the development of today’s crop genetic diversity in one way or another. Consequently, an important part of current crop production relies on the use of exotic species, and all countries depend, to some extent, on genetic diversity that originated elsewhere.

200 Sélim Louafi and Marie Schloen The current international flow of PGR takes place in many different forms, including, for example, the exchange of germplasm samples from ex situ collections, the sale of commercial seed and vegetative propagating material and intercompany transfers of genetic material under development. The international exchange of genebank accessions amounts to several tens of thousands of transfers annually and plays an important role in conservation and research and development, both in developing and developed countries. At the same time, it has to be noted that the majority of genetic material used directly in breeding and variety development comes from the breeding pools within one region and new ‘exotic’ material is only occasionally accessed. The modalities for the exchange of PGR depend on the crop in question and on the type of exchange partners. Generally speaking, the trend leans towards more formalized exchange practices, mainly through material transfer agreements (MTAs). Transfers of germplasm samples from genebanks are, for instance, increasingly regulated by MTAs. Contracting Parties to the International Treaty on Plant Genetic Resources for Food and Agriculture have agreed to use a standard contract, the SMTA (agreed multilaterally and non-negotiable), for each transfer of material belonging to the multilateral system of Access and Benefit Sharing under the treaty. This multilateral system includes ‘all PGRFA listed in Annex I of the Treaty [64 crops and forages] that are under the management and control of the Contracting Parties and in the public domain’ (Article 11.2). In an interesting development, the same standard contract (with a footnote) is also used by some national and international genebanks for the transfer of non-Annex I material. Exchange among commercial breeders is either free (in the case of the use of commercial varieties for further breeding) or regulated by commercial material transfer agreements. Exchange among farmers is limited by distance and social factors, but is generally free. The use and exchange of microbial genetic resources for food and agriculture (MiGR) The number of MiGR currently used for food or agriculture applications is small relative to the huge number of potentially useful species, partially due to technical limitations to the culturing of many living microorganisms. Agriculture applications of MiGR are nevertheless quite diverse: plant growth promoting agents; biological control; beneficial symbiosis in the guts of ruminant livestock; production of chemicals of direct benefit to agriculture; catalysts in agro-industrial processes; understanding and surveillance of microbial plant and animal (including fish) pathogens. Food applications are also quite varied: traditional fermentation (fermented foods); industrial fermentation of alcohol and wines; cheese production; probiotics; production of chemicals of benefit

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to food production (vitamins, organic acids, etc.); and the understanding and surveillance of health-hazardous micro-organisms such as food toxins and food-borne pathogens. MiGR are mainly used by screening vast quantities of naturally occurring microbes or microbial resources conserved in purified form in ex situ collections. Synthetic biology may involve genetic improvement, but this remains a marginal phenomenon, although it may grow in the future. Microbial culture collections (MCCs) are at the heart of the sector. All culture collections with major holdings in food and agriculture belong to the public sector or are non-profit organizations with major governmental funding. MCCs fulfil several objectives: procurement of cultures and ex situ conservation of micro-organisms; provision of authentic microbial cultures to industries and academic and research institutes; provision of identification, freeze-drying and other microbiology-related services; depository of patent cultures and research on microbial diversity, taxonomy and related areas. The majority of large MCCs are situated in OECD countries, where the majority of deposits, distribution and exchange also occur. However, many countries are actively involved in collecting and exchanging micro-organisms internationally, and microbial collections from non-OECD countries represent an important and growing subset in the overall network of culture collections. MiGR currently used in agriculture and food systems have been collected both from tropical and subtropical species-rich agro-ecosystems and from nontropical areas (Dedeurwaerdere et al. 2009). Because each MCC contains an important set of unique strains (an average of 40 per cent of the strains are unique), collaboration and exchange among MCCs is common (Dedeurwaerdere et al. 2009). These exchanges, as well as the flow from in situ to ex situ, occur in all geographical directions. Whereas historically these exchanges were quite informal, there has been a noticeable evolution towards formalization in recent decades (Dedeurwaerdere 2010). In particular, MCCs are moving increasingly towards the use of legal instruments: acquisition agreements when acquiring materials and MTAs when distributing them. Some important limitations, especially on further distribution to third parties, generally apply, even for non-commercial research, mainly for quality management purposes and to address biosecurity issues. When commercial development is involved, additional agreements with the initial depositor are often required, with the general understanding that the depositor is held responsible for prior informed consent from the country of origin. Exchange between qualified MCCs may involve simplified procedures. Both OECD and non-OECD collections include clauses related to legitimate/legal exchange in their MTAs, which allow public culture collections that comply with strict quality-management criteria to further distribute microbial research material that they have received from other

202 Sélim Louafi and Marie Schloen public MCCs (so-called legitimate exchange). The European Biological Resource Centres Network (EBRCN) and the Asian Consortium of Microbiological Resources (ACM) are making efforts to make the cultures available within the networks with few restrictions. However, in response to growing commercial opportunities and to financial restrictions on government spending on culture collections in some countries in the 1990s, this club model is threatened. Some MCCs have departed from the sharing and collaborating practices and have introduced restrictive MTAs, even for exchange among MCCs (Dedeurwaerdere et al. 2009). The use and exchange of genetic resources relevant for biological control (BC) The biological control (BC) of pests plays an important role in integrated pest management approaches in the food and agriculture sector. It is based on the use of natural enemies of pests, often referred to as BC agents. These are predators, parasitoids and pathogens of invertebrate pests, and herbivores that attack weed pests. There are two main categories of BC. Classical BC is the introduction of one or more BC agents, usually from a pest’s area of origin, to control the pest in an area it has invaded. Once introduced, the BC agent becomes established, reproduces and spreads. The BC agent then continues to have its effect on the target pest without the need for any further interventions. Augmentative BC involves the production and release of BC agents – indigenous or exotic – into specific crop situations, where they cause mortality in the target pest, but are not expected to persist from one cropping cycle to the next (Cock et al. 2009). The research and development process leading to the use of a new BC agent involves various steps that require access to genetic resources. The largest number of exchanges of genetic material takes place in the early stages of research and development, when it is necessary to study the target pest and its natural enemies. Preliminary surveys of the target pest and its natural enemies will often need to be carried out in several countries, and specimens of pests and natural enemies usually need to be exported for identification and taxonomic studies. Detailed studies on natural enemies to assess their potential as BC agents can, in part, be carried out in the source country, while host-specificity studies involving plants or animals not naturally occurring in the source country are best carried out in quarantine in the target country or in a third country. Overall, only a small fraction of all the species found and studied will actually be recommended for use and released as BC agents. Once a specific BC agent has been identified and is being released, there is little need for further exchange of genetic material (Cock et al. 2009). A particular attribute of classical BC is the public good nature of its activities. As classical BC agents establish and reproduce themselves in the target environment and, from that point on, are freely available, it is not

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possible to make any profit from their production and release. Consequently, classical BC is exclusively run by the public sector, mainly through national and international research institutions paid by governments or development agencies. Augmentative BC, in turn, is a relatively recently developed activity. The history of commercial mass production and sale of natural enemies spans less than 50 years. It is carried out by a relatively small number of companies worldwide, of which most are located in developed countries and the majority of which are medium- or small-sized. Even though augmentative BC agents are mainly produced for high-value crops such as greenhouse vegetables and ornamentals, the average profit margin is usually quite low. The international exchange of genetic resources relevant for BC plays a critical role in the functioning of the sector. The importance of exchange can easily be understood by looking at the case of classical BC. The introduction of a new classical BC agent is always linked to the use of exotic genetic material, as it follows the movement of target crops and pests around the world. In fact, the great majority of classical BC transfers are intercontinental, which is to be expected, as the target pests are themselves introduced species, often of intercontinental origin. Once a BC agent has been used successfully in one country, the opportunity is often taken to repeat the success in other countries through the redistribution of the agent. Consequently, the international flow of genetic resources related to BC has been quite significant, involving several thousand BC agent species from more than a hundred countries, and introductions into an even higher number of countries (Cock et al. 2009). As the BC sector is composed of a small number of actors, exchanges of genetic material have essentially been regulated informally, mainly by professional networks, which may be institutionalized or simply operate at a personal level. However, the informal character of exchange practices does not necessarily mean that no terms and conditions apply. Established ‘customary’ practices for use and exchange may, for example, foresee the sharing of results obtained from the use of the material or, in the case of research, the joint publication of results. In addition, in the augmentative BC sector, exchange practices are also regulated through classical commercial practices such as licensing production (i.e. larger augmentative BC companies license production to smaller companies as a way of facilitating the establishment of new companies in new countries to supply new markets) and intercompany supply (i.e. commercial augmentative BC companies sometimes buy BC agents from each other) (Cock et al. 2009).

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Part 2: Potential impact of ABS measures on the use and exchange of genetic resources for food and agriculture This section attempts to describe potential impacts of ABS measures on the use and exchange of GRFA, as assessed by the various stakeholders during the dialogues. A typical ABS scenario is envisaged in this regard. It aims to reflect the main features of typical approaches to ABS at the national level and serves to highlight some critical aspects of commonly used ABS measures. The most common approach to addressing ABS at the national level is through a purely bilateral and case-by-case approach. It consists of a national regulatory framework for ABS that provides for ABS conditions to be established bilaterally between provider and recipient on a case-by-case basis for each individual transaction of a genetic resource. This typical scenario is compared to two situations that might be referred to as the ‘status quo’. The first represents a hypothetical ‘ABSfree’ environment and serves to assess the impact of the ABS scenarios compared to no ABS at all. It assumes that there are no legislative, administrative or policy measures related to ABS in place. But it also assumes the absence of any ABS discourse or debate that would shape the perceptions, beliefs or behaviour of stakeholders. Consequently, ABS considerations do not play a role in the exchange of genetic resources, which is entirely framed by other issues such as sanitary or environmental concerns. This might, to a certain extent, resemble the status quo in some subsectors and user communities of the food and agriculture sector, in which the awareness of ABS is still very limited and has not as yet been directly affected by ABS measures. The second situation resembles the status quo as felt by most stakeholders in the food and agriculture sector, in which actors’ behaviour is already heavily influenced by the ABS discourse, but no fully functional ABS regulatory framework has been established. On the one hand, the exchange of genetic resources is dominated by high levels of politicization about questions related to the access to genetic resources and terms and conditions for benefit sharing. On the other hand, the situation is characterized by a lack of clear and transparent rules and procedures, unresolved competencies and responsibilities, and uncertainty on the part of most stakeholders on their rights and obligations. This creates an atmosphere of confusion and insecurity in which both potential providers and recipients of genetic resources fear being held responsible for unintentionally breaking the rules and are not confident that the system will safeguard their interests. The impact of ABS measures in general will be felt both by the providers of GRFA and by the users of GRFA. While the effects and implications will undoubtedly be different for the two groups and will be described as such in the following sections of this chapter, it is important to keep in mind that in the food and agriculture sector many stakeholders can act both as

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providers and as users of genetic resources and no clear-cut line can be drawn between them. The potential impact of ABS measures on the various aspects of use and exchange of GRFA will be described according to a set of parameters. Some parameters reflect the direct impact that ABS measures may have on transaction costs, etc. Other parameters are used to assess the indirect impact that ABS measures may have on the use and exchange of GRFA, mainly due to changes in the incentive structures for participating in GRFA exchange systems. These parameters reflect, for example, potential effects on the number and frequency of exchanges of GRFA, the volume of benefits shared, and the amount and type of activities carried out that involve the use of GRFA. They also take into account the implications that ABS measures may have for the different holders and user groups, and for different types of genetic material. Direct impact of access and benefit sharing on GRFA The direct impact of ABS measures can be felt from two sides. First, they have an effect on the transaction costs and time requirements for exchanging genetic resources and on the capacity needed by stakeholders to comply with the established measures and procedures. On the other side, they have an influence on the level of legal clarity and certainty governing the exchange of genetic resources and on the degree of trust and confidence that different stakeholders have in the system. Transaction costs, time requirements and capacity needs Generally, it can be said that the introduction of any ABS measure or regulatory framework means the addition of a new layer of regulation on the use and exchange of GRFA, and in many cases will lead to a formalization of previously informal exchange practices. As such, it is likely to provoke an additional administrative burden associated with the different steps in the exchange and use process, but could also provide new tools and mechanisms to facilitate interactions between different participants in the process and to overcome conflictual situations. The direction of the overall impact of ABS measures therefore depends on the status quo before their introduction. If the status quo is similar to the first described above (‘ABS-free’) where ABS considerations have not played a role in the exchange of genetic resources so far, then the establishment of an ABS regulatory framework would most probably mean an increase in transaction costs, time requirements and capacity needs for using and exchanging GRFA. This increase in transaction costs, time requirements and capacity needs is generated at the different stages of an ABS process. To go through all the required steps is not only very complex, time-consuming and cost-

206 Sélim Louafi and Marie Schloen intensive, it also requires substantial human, technical, and legal resources on the side of the users, both recipients and providers. They need to be prepared to interact with a whole range of different parties, they have to be able to comply with different legal systems and administrative procedures, they need to have the skills to conduct negotiations, and they have to set up the necessary information systems and management tools for monitoring the use of genetic resources and complying with contractual obligations. As normal business practices in the food and agriculture sector are characterized by an extensive transfer of genetic resources between different stakeholders along the value chain and imply a recurrent demand for access to germplasm, the described steps of the ABS process would not just have to be made once at the beginning of a research and product development process, but would need to be repeated many times during its course. GRFA are often exchanged in large numbers of samples of genetic material at different stages in the research and innovation process. As different stakeholders fulfil different functions in the value chain, GRFA are frequently passed on from one to another before reaching the stage of product development. Some of the stakeholders act more as intermediaries in the process, providing certain services like characterization, authentication or multiplication. All this leads to a high number of exchange events and a broad range of providers and recipients involved. Consequently, the costs, time requirements and capacity needs associated with every single transaction would be very burdensom for the research and development process as a whole. Another aspect adding to the complexity of applying a bilateral approach to ABS for GRFA lies in the fact that, for many GRFA, it can be quite complicated to identify the country that, according to the CBD definition, has provided the GRFA and is its country of origin and the rightful holder of the genetic material. This may have different reasons. For example, some GRFA move undetected across national borders by their own force (e.g. fish stocks moving freely across different jurisdictions), or by external forces (e.g. microbes being unintentionally moved with commodities, humans, etc.). Other GRFA are home to specific ecological niches that occur in many geographical locations all over the world (e.g. ubiquitous microbes). For domesticated and genetically improved GRFA, the difficulty is that they may have acquired their distinctive properties in many different surroundings and not just the one in which they are currently found. One of the most complicated and burdensome steps in the ABS process is the monitoring and tracking of the use of exchanged GRFA. On the one hand, this is due to the sheer number of samples of genetic material that are being transferred in the course of time and whose destiny needs to be followed. On the other hand, it is because users are required to track the many different genetic resources that may have been included in the

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innovation process at different instances and that have been received from a wide range of providers under varying terms and conditions. The tracking of GRFA becomes even more complicated in the case of incremental innovation based on genetic improvement. Then, a genetic resource does not preserve its genetic identity throughout the research and development process. On the contrary, its genetic components get mixed with others and always appear in new combinations and genetic setups. They could be described as a moving target for tracking in the sense that their genetic identity is under constant reconfiguration. Another difficulty in monitoring the use of GRFA arises from the fact that for some groups of GRFA there are no, or only very initial, monitoring systems in place and there is very little information available about their characteristics, properties and even taxonomic classification (e.g. for many aquatic genetic resources). The utilization of GRFA can also mean that they are released to the environment and that some of them will move on freely and independent from human action (e.g. biological control agents). For the reasons mentioned above, the costs for managing the sharing of benefits arising from the use of GRFA are likely to be quite high on a bilateral basis. The use of GRFA leads to relatively high numbers of released products, of which many have been developed with the contribution of several genetic resources. The individual genetic resources may have contributed to varying degrees and at different instances in the innovation process. It would be quite burdensome to trace the contribution of each individual genetic resource back to every product and to determine the respective beneficiaries and benefits to be shared, based on the specific terms and conditions agreed upon for every specific genetic resource. If ABS measures would also be applied to privately held genetic resources, such as live animals, commercial seed, brood stock, seedlings, etc., this would greatly increase the number of transactions covered and the range of potential providers and recipients affected. As such, it would add a considerable burden in terms of transaction costs and time requirements to established practices of use and exchange of GRFA, and would require a multitude of very diverse stakeholders to come up with the necessary capacity to comply with ABS procedures. As many agricultural products can also be used as a genetic resource, meaning as an input to further research and development, it could further interfere with normal market transactions and commodity trade. Trust, legal certainty and clarity The introduction of any ABS measure or regulatory framework has a direct impact on the level of legal clarity and certainty governing the exchange of GRFA and on the degree of trust and confidence that different stakeholders have in the system.

208 Sélim Louafi and Marie Schloen If the status quo is similar to the second one described above, then the introduction of any fully functional and well-managed regulatory framework for ABS has the potential to increase legal certainty and clarity of the system. ABS measures could, for example, achieve this by providing for clear and reliable rules of the game and making them accessible to everybody. This would, inter alia, mean clearly defining and spelling out the rights and obligations of all concerned parties; clearly assigning responsibilities, competencies and authorities; establishing transparent and simple administrative procedures; making all relevant information easily available; and ensuring compliance with and guaranteeing persistence of established rules and regulations. For both users and providers of GRFA, this would facilitate an understanding of the steps to be followed in the process of exchanging and using genetic resources, it would make the consequences of their own actions more predictable, reduce the risks associated with them, and make the behaviour of their counterparts more reliable. All together, this could contribute to an atmosphere of confidence and security, and thereby favour the interaction of stakeholders and engagement in the system. ABS measures could also have a positive impact on the trust and confidence that stakeholders have in a given use and exchange system for GRFA. The trust that stakeholders have in a system not only depends on the legal clarity and certainty it provides, but also on the perceived fairness and appropriateness of the rules it is governed by and the degree to which different stakeholders agree with those rules and believe that they adequately reflect their interests. In this sense, ABS measures could, for example, enhance the trust of providers of GRFA in the system by ensuring that they would be adequately rewarded for their efforts in developing, maintaining and providing genetic resources, and that their resources would not be misappropriated by others. Another gain in fairness could be reached if ABS measures would strengthen the rights of formerly marginalized or excluded stakeholder groups. This could, for example, be achieved by making sure that less sophisticated providers of GRFA receive a fair return for the genetic material they provide or by making genetic resources accessible to user groups with limited resources and capacity. In more general terms, stakeholder trust and confidence in any ABS system could be enhanced by involving them in its design and oversight, and by providing for their being heard in related decision-making processes. All of those examples would probably lead to an increased inclination of the stakeholder groups concerned to participate in the use and exchange of GRFA. As mentioned above, the potential positive impact that the introduction of ABS measures can have on legal clarity and certainty and stakeholder trust is dependent on the fact that the introduced ABS system is fully functional and well managed. If the required human, financial and technical capacity to fully implement an ABS system are not available and

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its implementation remains half-done, the effect is likely to be the opposite and will lead to an increase in uncertainty, confusion and insecurity. In the same way, if the status quo is characterized by long established and smoothly running exchange practices that are acceptable to all concerned stakeholders, changing the rules through the introduction of new ABS measures could disrupt the existing equilibrium and reduce the level of clarity and certainty. Indirect impact on the use and exchange of GRFA The potential indirect impact of ABS measures on the use and exchange of GRFA is mainly associated with the changes they may provoke in the incentive structure for providing, accessing and using genetic resources. First, this will have an influence on the overall number, frequency and type of exchanges of GRFA and on the volume of benefits that are shared. Second, it will affect the number and type of activities that take place involving the use of GRFA, the extent to which different stakeholder groups hold and use GRFA, and the degree to which different types of genetic material are used. Exchange of GRFA and benefits shared NUMBER, FREQUENCY AND TYPE OF EXCHANGES OF GRFA

The indirect impact that ABS measures may have on the number, frequency and type of exchanges of GRFA is caused by their influence on various aspects of the incentive structures for both providers and users of GRFA. For the providers of GRFA, ABS measures may create incentives for making their genetic material available by ensuring that the providers will be adequately rewarded for doing so. Conversely, ABS measures may increase the administrative burden of providing genetic resources, and thereby discourage providers from doing so. For the users of GRFA, the increased transaction costs, time requirements and capacity needs for complying with ABS procedures will usually be disincentives to accessing genetic resources. One risk in this sense is that stakeholders (both providers and recipients) who do not have the required human, financial, technical or legal capacity to go through all the steps of an ABS process may be excluded from the exchange of GRFA. Regarding the effect of transaction costs on the incentives for exchanging GRFA, it can be said that for both users and providers, the transaction costs must be justified by the benefits derived from the exchange of a genetic resource. On the user side, that means that transaction costs should not be higher than the monetary and non-monetary value of the exchanged material. For the provider, it means that the expected shared benefits should be higher than the costs incurred. The challenge in the food and agriculture

210 Sélim Louafi and Marie Schloen sector is twofold. On the one hand, the average value of an individual genetic resource is rather low. On the other, the average profit margin per product is also relatively low, in turn meaning that the individual benefits to be shared are also small. This leads to a situation in which transaction costs for providing and accessing genetic material can easily be higher than the benefits expected from the use of the genetic resource, and in which both users and providers are discouraged from exchanging GRFA. In contrast to the effects of additional transaction costs, ABS measures may have an encouraging effect on providers and users of GRFA by enhancing the level of legal clarity and certainty governing the exchange of GRFA and may thereby stimulate the flow of genetic resources. Whether the overall impact of ABS measures on the volume of exchanges of GRFA is dominated by their influence on legal clarity and certainty or by their effect on transaction costs, depends on the status quo they are compared to. If compared to the first status quo described above, ABS measures are likely to lead to a decrease in the overall number and frequency of exchanges of GRFA, as the effect of increased transaction costs, time requirements and capacity needs would probably prevail. If compared to the second status quo described above, it is possible that ABS measures might lead to higher rates of exchange of GRFA by providing the required (and previously absent) legal clarity and certainty. The effect of also applying ABS measures to privately held material would likely have a detrimental effect on the number and frequency of exchanges of GRFA. This is mainly because it would raise considerable concerns among private stakeholders regarding the legal certainty of their rights, and because of the risk of transaction costs becoming even higher due to the large numbers of stakeholders and exchange cases involved. Rather than diminishing overall exchange rates, another possible consequence of the introduction of ABS measures could be that transfers of genetic material increasingly circumvent the law. As the exchange of many GRFA was long based on informal exchange practices, the channels for unregulated transactions of genetic material often still exist. In this sense, high costs of complying with ABS measures bear the risk of creating an incentive for escaping legislation. In the same way that ABS measures may discourage the exchange of GRFA in general, they may also create incentives for stakeholders to switch from the use of foreign genetic resources to those that can be accessed within their own countries. Consequently, it can be expected that the cross-border exchange of GRFA will be more affected by ABS measures than exchanges overall. VOLUME OF BENEFITS SHARED

The benefits arising from the utilization of GRFA can be shared in many different ways between the various stakeholders involved in their

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development, conservation, provision and use. Apart from directly sharing the monetary benefits derived from commercialization, non-monetary benefits can, for example, be shared by sharing research results and information with other stakeholders or the broader public, the provision of access to data sets and material collections, cooperation between partner institutions in research and development processes, the provision of access to technologies developed from the use of genetic resources, and the creation of training and capacity building opportunities. The sharing of non-monetary benefits plays an important role in the food and agriculture sector because of two specific features of GRFA. On the one hand, the use of GRFA in research and development usually generates important non-monetary benefits that may in some cases be even more relevant than the profits that can be made. On the other hand, the potential for non-monetary benefit-sharing mechanisms, such as technology transfer, capacity building and information sharing, is increased by the fact that many countries make use of the same species, establish similar production systems and struggle with the same biotic and abiotic stressors. There is an important opportunity for ABS measures to realize this potential. With the fair and equitable sharing of benefits being one of the main objectives of ABS measures, their impact on the volume of benefits shared is likely to be positive. ABS measures can contribute to increasing benefit sharing in two ways. The policy debate about the rationale and objectives of ABS as such may raise the awareness and understanding of stakeholders regarding the relevance of benefit sharing and thereby stimulate the voluntary sharing of benefits on the initiative of stakeholders themselves. More importantly, ABS frameworks provide the legal basis for benefit sharing, bind users by concrete obligations to share the benefits of their use activities, and empower providers to demand adequate participation in the benefits generated. ABS measures have the potential not only to enhance the sharing of benefits, but also their generation. One potential benefit created by ABS measures may, for example, lie in the establishment of information sharing mechanisms and the compilation of information about the genetic resources held in a given country and their characteristics and properties. As the availability of information is one of the main limiting factors in locating promising GRFA for research and development, this would greatly facilitate the use of GRFA. The same would be true for the information collected through monitoring the use of exchanged GRFA, which could provide valuable insight relevant to their management and conservation. Another potential benefit generated by ABS measures could arise in the form of enhanced partnerships and greater cooperation between users and providers of GRFA and between foreign and local users. Nevertheless, there may be two pitfalls in attempting to increase the volume of benefits shared through ABS measures. One of these is related

212 Sélim Louafi and Marie Schloen to the potential negative impact of ABS measures on incentives to exchange and use GRFA, which would in turn lead to a decline in the benefits generated from their use. The other pitfall arises because in the food and agriculture sector, the individual monetary benefits to be shared can be rather limited compared to the transaction costs associated with the sharing of an individual benefit. Several specific features of GRFA contribute to this situation. First, the profit margin per product developed with the use of GRFA is relatively low on average. In addition, many products are developed with the contribution of several genetic resources, meaning that benefits have to be shared with several providers. Finally, for every individual genetic resource used, several parties (i.e. providing institution, local community, state) may have the right to participate in the sharing of benefits. Altogether, this leads to rather low average monetary benefits to be shared on an individual level and makes it very complex and costly to organize benefit sharing on a bilateral, case-by-case basis. The application of ABS measures to privately held material would have the advantage of covering a larger proportion of all benefits generated through the use of GRFA and could thereby increase the amount of benefits shared. However, this advantage could be outweighed by the detrimental impact that reduction in exchange and use activities caused by the disincentives created by ABS measures would have on the generation of benefits from privately held material. Use of GRFA The indirect impact that ABS measures may have on the use of GRFA is generated by their influence on the availability of genetic material (through modified incentives for the exchange of GRFA) on the one hand, and their effect on capacity to conduct research and development and conservation activities (through enhancement of capacity via benefit sharing) on the other hand. ABS measures could thereby have an impact both on the overall level of use of GRFA, and on the relative incentives for carrying out particular types of use activities, involving particular groups of holders and users and including particular types of genetic material under particular types of ownership. However, ABS measures constitute only one among many factors influencing the incentive structures for investing in and carrying out activities involving the use of GRFA. The following discussion of the potential effects of ABS measures on the use of GRFA is consequently rather indicative, with actual outcomes being heavily dependent on the specific contexts. TYPE OF USE ACTIVITIES

GRFA are used for a broad range of activities including in situ and ex situ conservation, basic and applied research, breeding and product

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development, and farming and production activities. ABS measures have the potential to influence the incentive structure for investing in these different types of use and may lead to changes in the amount and type of activities carried out. Because an important part of genetic diversity used in the food and agriculture sector today is of exotic origin and because cross-border exchange plays such an important role in the normal functioning of the sector, reduced exchange rates of GRFA could have a detrimental effect on the overall volume of use activities. Generally speaking, the consequences of increasing the barriers to exchange will be most severe for activities that require the exchange of large amounts of genetic material. This could hamper, for example, the early stages of research when vast amounts of still largely uncharacterized organisms have to be exchanged for screening. It could also adversely affect genetic improvement and breeding activities that rely on recurrent exchanges of germplasm. It can also be expected that activities relying mainly on public funding and those that do not generate high returns will be more severely affected by costly and lengthy exchange processes. This is because both factors would make it more difficult for the stakeholders to cover the extra costs involved in complying with ABS procedures. Activities affected would include, for example, basic research, conservation and breeding, and product development for resource-poor farmers and marginal environments. In more general terms, one of the challenges facing the food and agriculture sector is that there is already a lack of investment in many activities involving the use of GRFA, relative to what would be required in order to meet demand for agricultural products and ensure food security. This is, for example, the case for genetic improvement and breeding activities in nascent sectors such as aquaculture and also in a wide range of other areas, including the conservation of GRFA. In this context, the risk of further discouraging the use of GRFA through increased costs seems quite high. Depending on the scope of ABS measures, some activities might be more directly affected than others. For example, it can be expected that a possible reduction in exchange rates of GRFA would have an immediate effect on research and development activities, while it might not directly affect production or farming activities. However, the latter would also be affected at some point, as they are part of the same value chain. As some GRFA are held privately and the private sector is strongly engaged in the use of genetic resources in the food and agriculture sector, the potential impact of ABS measures also depends on the question of whether or not they cover privately held genetic material. The difference would obviously be felt most in sectors and activity areas where the private sector plays an important role. For instance, livestock breeding is largely carried out by private actors and would be more heavily affected if ABS measures were also to cover privately held genetic material.

214 Sélim Louafi and Marie Schloen On the other hand, ABS measures have the potential to enhance the use of GRFA. Through the increased sharing of benefits, they may lead to better availability of financial, technical and human capacity for the various use activities. It can, for instance, be expected that the research and development capacity of providers of GRFA would be enhanced through the transfer of advanced technologies, the sharing of research results and the provision of training. The use of GRFA could also be generally promoted through the generation and sharing of benefits on a collective level, such as the establishment of information sharing mechanisms for GRFA. One particular concern in the food and agriculture sector is the potential influence of ABS measures on the conservation of genetic resources. On the one hand, conservation activities might profit from increased capacity and means, provided through effective benefitsharing mechanisms. On the other hand, some additional costs related to the collection of genetic material and its eventual provision to others (transaction costs for accessing, managing, providing and monitoring or tracking GRFA) would have to be borne. ABS measures may also provide an incentive to invest in the conservation of GRFA, as efforts might be rewarded through the sharing of benefits in the future. However, the returns that can be expected from such an investment in the near or medium-term future are usually quite limited in the food and agriculture sector. Most of the potential value of the GRFA that needs to be conserved today will only be realized in the distant future and remains rather uncertain. In general terms, it is not expected that the resources that could be mobilized through ABS measures would match those that would be required to effectively conserve GRFA. ABS measures alone could, therefore, not solve the problem of adequately financing the conservation of GRFA. Another consideration in the food and agriculture sector is that the utilization of GRFA in research and development and production is an important means of ensuring their conservation. Hence, if ABS measures negatively affect such activities, they will hinder the conservation of GRFA. TYPE OF HOLDERS AND USERS OF GRFA

In the food and agriculture sector, genetic resources are held and used by a wide range of stakeholders, including subsistence farmers and local communities, the market-oriented farming sector, public and private genebanks and collections, research institutions at national and international levels, and small- and large-scale companies and enterprises. ABS measures could affect the various stakeholder groups differently, as the measures may be better adapted to the practices and capacity of some stakeholders than to those of others. It is also possible that they apply only to certain stakeholders and not to others.

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The different holders and users of GRFA vary considerably with respect to their financial, administrative and legal capacity. Generally, it can be expected that stakeholders who have less capacity and fewer resources for coping with lengthy administrative and legal processes will be more adversely affected than those who are able to absorb the additional costs. For instance, it is likely that local producers, researchers and communities will have more difficulty in complying with ABS procedures and requirements than large international companies. As many users and holders of genetic resources in the food and agriculture sector have only quite limited capacity and resources, this would imply the risk of excluding them from the exchange and use of GRFA. At the same time, it can also be assumed that better equipped stakeholders may benefit more from the monetary and non-monetary advantages derived from the use of GRFA. Because of the dual nature of many stakeholders in the food and agriculture sector (i.e. both as recipients and providers of GRFA) and the interdependence of the various stakeholders along the value chain (in terms of the distribution of tasks and functions related to the conservation and use of GRFA), all actors may potentially be affected by ABS measures, independently of whether or not their activities are directly regulated by such measures. For instance, farmers and local communities could be affected as direct users of genetic resources if such uses are subject to ABS measures. But even if their activities are excluded from the scope of ABS measures, they could still be indirectly affected through the impact that the measures might have on research and product development activities upon which they depend. The important role played by ex situ collections in some of the subsectors of food and agriculture also raises some specific issues. The collections often function as intermediaries between countries of origin and potential recipients of genetic material, and in addition provide public services such as conservation, storage, characterization and authentication. However, while bearing the administrative costs of ABS measures, they themselves would often not benefit from the potential benefit sharing derived from the use of the genetic material they provide, as they simply act as brokers between the country of origin and the recipient. TYPE OF GENETIC MATERIAL USED

ABS measures may also have an indirect effect on the type and diversity of genetic material accessed and used in the food and agriculture sector. They may change the incentives for exchanging and using different types of genetic material by applying different conditions to them or by only covering certain types of material while others continue to be freely available. A first general observation is that because of differences between countries’ ABS systems and the respective obstacles perceived, users may

216 Sélim Louafi and Marie Schloen prefer certain countries and avoid others. In particular, users would look for countries and providers that provide legal certainty over the genetic material, have clear and transparent ABS rules, have information about the monetary and non-monetary value of the material they provide, and have established cost and time-efficient exchange procedures. Consequently, differences between national ABS regulatory frameworks may induce a shift in the geographic distribution of material accessed and used. In the same way, ABS measures may also lead to increased use of local genetic material at the expense of foreign material. Furthermore, the choices that users make between different types of genetic material within the context of a given ABS regulatory framework may be influenced by the scope of material covered by the framework. This is because, depending on the level of legal clarity and certainty provided and the degree of administrative burden generated by an ABS framework, some users may have a tendency to give priority to accessing genetic material that is not covered by the ABS measures. This could lead to a situation in which the use of GRFA found in situ or stored ex situ (which are more often publicly held and covered by ABS measures) decreases, relative to the use of GRFA already contained in breeding pools and production populations (which are more often privately held and not covered by ABS measures). In the same way, and independently of whether or not privately held material is also covered, ABS measures could create an incentive for users to resort to genetic diversity that is already under their management instead of accessing ‘new’ material. Increased costs related to the exchange of GRFA could also direct access and use towards genetic material with higher potential value (e.g. well characterized and evaluated). All these factors would run counter to the objective of bringing underutilized genetic diversity into use and broadening the genetic base of breeding and production populations. As the utilization of GRFA can be an important tool in their conservation, this could also compromise the effective conservation of genetic diversity in the food and agriculture sector. Conversely, if an ABS regulatory framework provides clear and transparent rules and efficient and streamlined procedures, the material covered by such a system might become more attractive than the material not covered. Because of the legal certainty and low-risk conditions it would provide compared to an unregulated situation (where, for example, reputational risks are incurred), such an ABS system could induce a shift in favour of genetic material targeted by regulation. Finally, another risk associated with ABS measures that needs to be taken into account in the food and agriculture sector is that of interfering with agricultural commodity trade. This risk arises because many agricultural products are at least potentially able to be used as genetic resources for further research and development, and because the purpose for which they will be used (i.e. only as biological resources or

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also as genetic resources) is often uncertain at the time of transaction. This creates the need for any ABS regulatory framework to clearly define its scope in terms of the types of genetic material and types of use covered.

Part 3: Conclusions on potential principles and approaches for better addressing ABS in the food and agriculture sector This section aims to draw some conclusions and outline possible principles and approaches for the design and implementation of ABS measures and regulatory frameworks for GRFA. The principles and approaches identified can be grouped into the following three clusters, each of which is discussed in more detail below: • • •

improving the bilateral approach through increased legal certainty and centralization of ABS processes; the pooling of material; decoupling benefit sharing from individual genetic resources.

Improving the bilateral approach Considering the high degree of interdependence between countries, along with the strong need for access to genetic resources in the sector, administrative bottlenecks created by ABS legislations bear the risk of dramatically restricting international exchanges of genetic resources in the food and agriculture sectors. This may potentially have adverse effects on the sector and its capacity to sustain agricultural production and ensure food security. Article 6.3 of the Nagoya Protocol requires, inter alia, Parties to ‘[p]rovide for legal certainty, clarity and transparency of their domestic access and benefit-sharing legislation or regulatory requirements …’. The principle of transparency and clarity is, inter alia, related to the scope of ABS measures and regulatory frameworks. Because of the often dual nature of GRFA (i.e. many GRFA can potentially be used both as biological resources and as genetic resources) and the fact that a significant part of genetic diversity is privately held, a lack of clarity regarding the material covered under an ABS framework may have important consequences. In particular, it is important that potential interfaces with agricultural commodity trade are taken into account and that the implications of the scope of ABS measures are carefully considered in this regard. Legal certainty is strongly influenced by the degree to which ABS measures are informed of the technical realities dealt with, the nature of the activities regulated and the actual costs involved. The active involvement of stakeholders is a good way to ensure that ABS rules and regulations build upon existing exchange practices and modalities, and

218 Sélim Louafi and Marie Schloen adequately reflect the often dual role (both as providers and users) taken by stakeholders in the food and agriculture sector. Because ABS is a complex issue involving multiple dimensions – including conservation of genetic diversity, promotion of innovation, equity and development – diverging or competing interests amongst ministries and various competent authorities may easily take place, which may, in turn, create administrative bottlenecks. By centralizing competencies and harmonizing procedures in a single Competent National Authority (CNA), centralized approaches could streamline procedures by reducing the number of bilateral interactions needed between different parties throughout the ABS process, in particular for the establishment of prior informed consent and mutually agreed terms. This would basically mean that the state takes over certain tasks in the ABS process that would otherwise have to be fulfilled by individual providers and recipients of genetic resources. Harmonization of procedures may also imply a certain degree of standardization of the terms and conditions for ABS in order to reduce the negotiation costs associated with each individual transaction. This could go up to the establishment of standard contracts for certain types of uses or resources. The above considerations are based upon the assumption that the ABS system in question would be fully implemented and operational, and that the responsible authorities would have the necessary resources and competence. If this is the case, the centralized and standardized approach could have a less negative or even positive effect on the amount of GRFA exchanged. The centralized functions and harmonized procedures have the potential to provide for a more streamlined, simple and clear system which could offset the discouraging effect of an additional bureaucratic layer once stakeholders are accustomed to it. One of the main advantages of this approach compared to a purely bilateral and case-by-case approach is related to the balance between transaction costs per individual transfer (for both providers and recipients) and the benefits derived from the exchange of an individual genetic resource. By centralizing exchange-related functions in the hands of a centralized national authority, harmonizing procedures and/or standardizing terms and conditions for ABS, this approach would potentially reduce transaction costs per individual transaction considerably and could thereby positively influence the balance. Harmonizing legal conditions under which GRFA are exchanged may also have the advantage of allowing users to mix different genetic resources and their components into their genepools without the risk of ‘contaminating’ them with a multitude of unmanageable contractual obligations. Another positive effect is that the centralized national authority takes over some functions and tasks from the individual providers and users, and consequently reduces the risk of less well-

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equipped stakeholders being excluded from the exchange of GRFA due to a lack of capacity. Possible downsides of a centralized and standardized approach could be a lack of flexibility and responsiveness to address case specific circumstances and diverse stakeholder needs and an overly rigid implementation by a central authority, taking the process out of the hands of those directly involved in the transaction. Hence, a balance should be found between the use of standardization to realize economies of scale and the provision of sufficient flexibility to accommodate the needs of different stakeholders and types of transaction. It would also be important to ensure sufficient stakeholder involvement in the design and oversight of the system and to build upon the existing capacity of stakeholders related to the exchange of genetic resources. Pooling The complexity of managing ABS at the level of individual transactions between individual providers and recipients is described in previous parts of this chapter. The extensive exchange of GRFA between the various stakeholders along the value chain and the fact that products are often developed from several genetic resources, each of them contributing to the final product to a different extent, and each coming from a different provider and transferred at a different point of time under different ABS conditions, imply complex ABS processes that might easily become very cumbersome and costly. Furthermore, for many GRFA, it can be quite difficult to identify the country of origin and the rightful holder of the genetic material. Moreover, the relatively low average value of individual genetic resources and the relatively low profit margin of most products mean that it is easy for the costs of managing ABS processes on an individual basis to exceed the expected benefits. Finally, the high redundancy of exchange events in the food and agriculture sector offers the opportunity to realize economies of scale. One way to realize economies of scale and decrease the transaction costs associated with the management of ABS on an individual basis is the pooling (or aggregation) of genetic material. This automatically implies a certain degree of harmonization of ABS terms and conditions. This could, for example, be implemented through the establishment of an organization to manage collective rights (i.e. on behalf of individuals) and define standardized ABS procedures and conditions for a whole set of transactions and genetic resources. This approach has already been implemented by some actors in some sectors. Examples can be found at the level of professional networks as well as at international levels (e.g. International Treaty on Plant Genetic Resources for Food and Agriculture). Pooling also reduces the difficulty of handling genetic material under a multitude of different legal conditions, for example in genetic

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improvement processes. By providing harmonized or even standardized ABS conditions for a whole set of material, pooling also facilitates the management of benefit sharing, for example in the case of commercialization. In addition, it encourages the use of a wider range of diversity (because the whole range is available under the same conditions) rather than focusing access on the genetic material provided by particular providers. The pooling approach could also be extended to benefit sharing. Delinking the sharing of benefits from individual providers breaks the usual ‘give and take’ logic of ABS by acknowledging the collective and incremental nature of the innovation process. In addition, the pooling of benefits in a common fund reduces the administrative costs of organizing the sharing of benefits and the need to split benefits into a large number of small shares. In the case of GRFA, it is often very difficult to identify the extent of individual contributions to a product. When it is possible, the average value of individual contributions remains rather low in most cases. Consequently, the costs of organizing benefit sharing on an individual basis would often be higher than the individual benefits to be shared. Decoupling the sharing of benefits from the individual provider and lifting it to a collective level would allow for a reduction in the administrative costs associated with the sharing of benefits. The pooling approach to benefit sharing is also better adapted to realizing the full potential of non-monetary benefit sharing, because it is able to take advantage of additional benefits that can only be generated on a collective basis, such as the development of information sharing mechanisms. It may also enhance the sharing of non-monetary benefits through better coordination of stakeholder needs and more effective identification of benefit-sharing options of relevance to a wide range of beneficiaries in the country. This approach has already been implemented at the international level within the framework of the multilateral system of access and benefit sharing of the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA). But it could also be implemented at the national level or at the level of a user community. Despite potential advantages, pooling may also involve some costs and disadvantages. First, there is a balance to be struck between the use of standardization to lower transaction costs and ensuring the flexibility needed to address the specificities of different cases involving different types of genetic resources, various use purposes and diverse stakeholders. Hence, the degree to which the potential for pooling and standardization can be realized depends upon the quality of their implementation. In this context, the general principles described above (transparency and clarity) play an even more important role than in the implementation of a completely decentralized and case-by-case approach to ABS.

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Decoupling Another approach to overcome the difficulties in managing ABS on a purely bilateral and case-by-case basis is decoupling the sharing of benefits from the individual sample level. This would imply that benefits are not shared based upon the use of an individual germplasm sample, but upon the use of GRFA on a more aggregated level. The decoupling of benefit sharing from the actual use of an individual genetic resource would have the enormous advantage of completely removing the need to track the use of individual genetic resources. In the food and agriculture sectors, one of the most complicated and burdensome steps in the ABS process is the monitoring and tracking of the use of exchanged GRFA. This is due to a variety of circumstances: the sheer number of samples of genetic material that are transferred; the fact that many different genetic resources coming from a wide range of providers under varying terms and conditions may be included at different points of time and contribute, to different extents, to the development of a specific product; the fact that for some GRFA, there are no or only very initial monitoring systems in place and that some GRFA might be released into the environment and move on independently from human action; and lastly, the fact that in the case of genetic improvement, GRFA do not preserve their genetic identity throughout the development process and become a moving target for tracking. In general terms, as products are usually developed with the contribution of many genetic resources, it is often quite difficult to assess the contribution of a specific GRFA to a product, and the average value of that individual contribution will be rather low. Decoupling the sharing of benefits from the use of individual genetic resources is consequently a promising way to keep monitoring costs as low as possible, at least below the expected added value of an individual transaction of GRFA. This kind of decoupling is much more speculative in the sense that it has never, to our knowledge, been tried in any existing ABS framework. If such an approach were implemented, there would be a need to address the question of how it could be guaranteed that the actual benefits derived from the use of GRFA would still be shared. The solution would lie in triggering benefits from use activities in general. Benefits could be shared at two points of the value chain: at the point of sale of reproductive material or at the point of sale of consumption products derived from GRFA. The costs involved could be borne by the producers of reproductive materials or consumption products, the consumers of those goods, or the taxpayers if benefits are managed at the national level through budgetary means. It could also be a combination of these three groups and could be implemented to different degrees at national, regional and international levels. Many of the potential benefits of decoupling are related to the special nature of innovation processes with GRFA, which are often incremental

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and based on multiple individual shares that contribute to one product. However, it is also important to consider some of the possible drawbacks of decoupling. First, if benefit sharing is decoupled from the individual provider, this might decrease the incentive of the provider to make material available. Second, decoupling benefit sharing from use, even if there are important transaction cost gains for all, might, in some cases, lead to less willingness to pay, as the level of payment would be determined in accordance with the benefits from use activities in general, without necessarily differentiating between high added value uses and low added value uses. In this regard, a proper balance between general cost sharing (such as in a tax system) and more targeted contribution from those who have the highest willingness to pay, because they are the direct beneficiaries of a specific added value or service (such as in a mandatory insurance or a liability system), would have to be carefully considered. In general, therefore, careful consideration would have to be given to the various possible models of decoupling, which may be partial or total and which may be more or less use specific. In conclusion, we have shown that several ABS approaches could accommodate the distinctive features of GRFA. In all cases, these approaches result from the recognition of the difficulty in efficiently applying a purely bilateral and case-by-case approach of ABS. Many established practices of use and exchange of GRFA already involve a certain degree of collective management, whether for access, conservation or benefit-sharing activities. In addition, the broad range of very diverse stakeholders, the incremental nature of the innovation process, and the interdependency among countries for food security are specific features of GRFA that benefit from some kind of coordinated and/or collective action and solutions. In this context, it is noticeable that the most advanced existing international instrument for ABS for GRFA, namely the multilateral system of the ITPGRFA, has taken up the collective pooling approach. It strongly expresses the need for cooperation in the management, conservation and distribution of GRFA and can be seen to be the most integrated and collective way of managing globally and in a coordinated and coherent way a distributed, but still common, pool of genetic resources (Louafi, 2012: 312).

Note 1

The list of participants can be found in the Annex to the report published by FAO as a background study, http://www.fao.org/docrep/meeting/023/ mb720e.pdf, viewed 21 January 2013. While this contribution attempts to reflect the discussions, findings and outcomes of the Multi-Stakeholder Expert Dialogue as accurately as possible, the responsibility for its content remains entirely with the authors of this chapter.

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References Bartley, DM, Benzie, JAH, Brummett, RE, Davy, FB, De Silva, SS, Eknath, AE, Guo, X, Halwart, M, Harvey, B, Jeney, Z, Zhu, J, Na-Nakorn, U, Nguyen, TTT and Solar, II (2009) ‘The use and exchange of aquatic genetic resources for food and agriculture’, CGRFA, Background study paper no. 45, FAO, Rome. Cock, MJW, van Lenteren, JC, Brodeur, J, Barratt, BIP, Bigler, F, Bolckmans, K, Cônsoli, FL, Haas, F, Mason, PG and Parra, JRP (2009) ‘The use and exchange of biological control agents for food and agriculture’, Background study paper no. 47, Commission on Genetic Resources for Food and Agriculture, FAO, Rome. Dedeurwaerdere, T (2010) ‘Global microbial commons: institutional challenges for the global exchange and distribution of microorganisms in the life sciences’, Research in Microbiology, 161 (6), 407–413. Dedeurwaerdere, T, Iglesias, M, Weiland, S and Halewood, M (2009) ‘The use and exchange of microbial genetic resources for food and agriculture’, Background study paper no. 46, Commission on Genetic Resources for Food and Agriculture, FAO, Rome. FAO (2009) ‘The use and exchange of animal genetic resources for food and agriculture’, Background study paper no. 43, Commission on Genetic Resources for Food and Agriculture, FAO, Rome. Gjedrem, T (ed.) (2005) Selection and breeding programs in aquaculture, Springer, Dordrecht. Koskela, J, Vinceti, B, Dvorak, W, Bush, D, Dawson, I, Loo, J, Kjaer, ED, Navarro, C, Padolina, C, Bordács, S, Jamnadass, R, Graudal, L and Ramamonjisoa, L (2009) ‘The use and exchange of forest genetic resources for food and agriculture’, Background study paper no. 44, Commission on Genetic Resources for Food and Agriculture, FAO, Rome. Louafi, S (2012) ‘Collective action challenges in the implementation of the multilateral system of the International Treaty: what roles for the CGIAR centres?’, in Halewood, M, Lopez Noriega, I and Louafi, S (eds), Crop genetic resources as a global commons. Challenges in international law and governance, Earthscan, London, pp. 310–328.

11 Global scientific research commons under the Nagoya Protocol Governing pools of microbial genetic resources Tom Dedeurwaerdere, Arianna Broggiato, Dimitra Manou Introduction International cooperation in scientific research is essential for the conservation and sustainable use of biodiversity. In particular, there is a growing need for global sharing of basic knowledge assets for scientific research, such as databases, biological research materials and research results in order to address complex issues of global concern, such as the impact of invasive species on biodiversity, global pandemics or the resilience of complex, coupled social–ecological systems. International efforts in this direction include online access to the Millennium Ecosystem Assessment organised by the United Nations Environment Programme, the Multilateral System for the exchange of seed germplasm established under the International Treaty on Plant Genetic Resources for Food and Agriculture, and the global marine database of the Census of Marine Life. The importance of international cooperation for biodiversity research was recognized early on in the broader context of debates in international environmental law. Principle 20 of the 1972 Stockholm Declaration of the United Nations Conference on the Human Environment underlines that the ‘free flow of up-to-date scientific information and transfer of experience must be supported and assisted, to facilitate the solution of environmental problems; environmental technologies should be made available to developing countries’ (UN Declaration on the Human Environment 1972). This requirement has been reiterated in principle 9 of the 1992 Rio Declaration on Environment and Development which indicates that states should cooperate ‘by improving scientific understanding through exchanges of scientific and technological knowledge, and by enhancing the development, adaptation, diffusion and transfer of technologies’ (Rio Declaration on Environment and Development 1992). However, with some notable exceptions in specific fields, such as the United Nations Convention on the Law of the Sea

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(UNCLOS 1982), the Antarctic Treaty (Antarctic Treaty 1959) and the FAO’s 2001 International Treaty on Plant Genetic Resources for Food and Agriculture, the international legal framework for implementing these declarations has been limited to the ‘commercial’ end of the research chain1 and has focused mainly on the issues surrounding technology transfer and intellectual property rights (Article 66.2 of the Agreement on Trade-Related Aspects of Intellectual Property Rights 1994). As a result, outside the specific areas of application of these international agreements, there is not a clear legal framework under public international law establishing the rights and duties of global research collaborations with basic knowledge assets for scientific research, in spite of evidence of increasing restrictions on access to basic research assets in areas such as scientific publishing, 2 access to research samples (Jinnah and Jungcurt 2009: 464) and access to databases (Reichman and Okediji 2009: 1). In this context, the text of the Nagoya Protocol and the preceding nonbinding principles formulated under the Bonn Guidelines offer new opportunities for bridging this gap, by explicitly including provisions that address the global organization of scientific collaboration at the noncommercial stages of the research cycle (Reichman et al. forthcoming). As can be seen in particular in the annex to the Protocol, a broad variety of non-monetary benefit-sharing measures are envisioned as a means to organize a fair and equitable sharing of research benefits in the upstream dimensions of the research cycle. Moreover, other articles of the Protocol, such as Articles 8, 10 and 11 explicitly address the issue of non-commercial and/or trans-boundary research cooperation. The precise manner in which these and other provisions of the Nagoya Protocol will have an impact on global research collaborations with basic knowledge assets for scientific research is still a question of intense debate. Two major competing institutional models dominate this debate. The first model starts with the assumption of exclusive ownership rights on knowledge resources, case-by-case contractual negotiations for access to the knowledge assets for basic research between individual providers and individual users of biological resources and associated data and information. Under this model, the basic knowledge assets are governed in a similar way to commercial research assets as ‘quasi-private’ goods in international exchanges. The same general procedures as those applied to potentially commercial research assets apply to these resources. A typical example of this first model is the international Rice Research Consortium, which is a global research consortium for the exchange of basic research assets, which was negotiated on an ad hoc basis between the various national members of the consortium. The second model envisions nonexclusive property right regimes on a global scale for upstream research assets, established through an agreement between the legal right holders of basic knowledge assets that decide to make these assets available under global public domain-like conditions for specified research uses. Under

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the second model, knowledge assets are governed as common goods on a global scale. Examples of the second model are the Multilateral System of the International Treaty on Plant Genetic Resources for Food and Agriculture, the system of open access publishing and the global DNA database consortium Genbank/Embl/DDJB.3 This chapter aims to compare these two models for implementing the Nagoya Protocol, in the specific field of microbiology. The field of microbiology has a long history of global collaboration, especially between the ex situ collections of microbial organisms that are members of the World Federation of Culture Collections (WFCC). Therefore, the case of these microbial culture collections is particularly interesting to analyse in relation to possible institutional arrangements for organizing access to basic research assets under the Nagoya Protocol. The chapter is organized as follows: first, some major examples of the social benefits of organizing global collaboration with microbial resources are presented. Second, some of the limits of the conventional economy approach for understanding existing governance arrangements with essential research assets are analysed and principles of an alternative, commons based model are outlined, followed by an analysis of the functioning of the commons-based model through an empirical survey of existing contractual agreements for exchange of materials between public culture collections. Finally, an analysis of the science-related articles of the Nagoya Protocol will be made showing the need to consider a broad interpretation of the notion of non-commercial use in the implementation of the Protocol in order to preserve the commons-based exchange practices that are essential to global cooperation for basic biodiversity research

Global collaboration with microbial resources for public health, food security and biodiversity conservation The in situ conservation of microorganisms is not sufficient for organizing systematic research of microbial biodiversity and its sustainable use for a number of reasons, in particular because microorganisms replicate frequently and need special equipment for their study. Microorganisms that are isolated from the environment are typically conserved and made available for systematic, comparative research by culture collections, which are organized to acquire, conserve and distribute microorganisms and information about them with a view to fostering research and education. The two main types of institutional mechanisms in place for organizing the distribution of these basic research assets are the formal public service collections on the one hand and the informal in-house research collections on the other. A first example of formally organized collections is the network of formal public service culture collections which are members of the World

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Federation for Culture Collections. These collections are formally organized to distribute high-quality microorganisms for research purposes, have public catalogues of their holdings and increasingly use formal arrangements for distributing microorganisms. They collectively distribute over 1.2 million publicly available research samples on a yearly basis, both in developing and developed economies (Dedeurwaerdere et al. 2009). In addition, over 200,000 new samples collected from natural environments in all geographical regions of the world are still deposited each year in these collections. These collections are characterized by a high level of interdependency. Even the American Type Culture Collection, one of the largest public culture collections in terms of distribution with approximately 25,000 microbial samples, holds less than 2 per cent of the total microbial holdings of the WFCC members and only a minor fraction of the currently known microbial biodiversity. Intense collaboration and exchange amongst public culture collections is a necessary consequence of this situation. In more recent history, the global collaborations between the culture collections have been expanded to include public databases containing information on the country of origin, scientific publications related to the microbial holdings of the collections and automatic linkage to associated genomic information (Dawyndt et al. 2006: 251; Reichman et al. forthcoming). A second example of formally organized global networks of microbial collections is the Global Influenza Surveillance and Response System (GISRS),4 a network established by the World Health Organization (WHO). Established in 1952, this network comprises six WHO Collaborating Centres and 136 National Influenza Centres that collaborate to monitor and process influenza viruses. For example, in 2010 over 140 samples of viruses and/or clinical specimen collected from various regions of the world were distributed over the six WHO Collaborating Centres for pre-screening in the development of a vaccine for H1N1.5 In general, these collections organize non-commercial research of the evolution of influenza viruses and provide recommendations in areas including laboratory diagnostics, vaccines, antiviral susceptibility and risk assessment. The second type of institutional arrangements for distributing microbial organisms is based on informal distribution by in-house research collections, where the bulk of microbial research is done. These in-house research collections play an important role in the overall research cycle, because it is there that the first selection and screening of reference materials is undertaken. In contrast to the formal institutional mechanisms, these collections typically do not use formal transfer agreements for distributing microbial research assets and do not have public catalogues of their holdings. However, they are an important component of the overall research infrastructure, as it would be too expensive to conserve all microbial genetic resources in the formal WFCC

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collections, where strict quality management procedures for long-term preservation have to be observed. The examples of formally organized global pools of microbial organisms contrast with the global exchange of microbial samples by informal networks of exchange amongst researchers working in in-house research collections. The main advantage of these informal networks for the organisation of collaborations with basic scientific research assets is to lower transaction costs compared to the use of formal material transfer agreements (MTAs).6 Mostly, such informal arrangements allow the use of the research materials in the recipient’s laboratory but for non-commercial purposes only. As a consequence, the agreements come with few, if any, strings attached to the use of the materials (Dedeurwaerdere et al. 2009). At the same time, the tacitly recognized quality management standards observed by trusted members of the club guarantee the authenticity and integrity of the materials exchanged. Because of their presumed efficacy, these informal pools operate in parallel to the formally organized global pools considered above. However, the informal exchange networks also exhibit a series of major disadvantages which have to be considered when thinking about the possible institutionalization of microbial research pools within the emerging system of the Nagoya Protocol (Reichman et al. forthcoming). The main disadvantages are the lack of openness of the informal pools, which leads to high search costs for scientists when they are comparing or testing their research findings with ongoing research in other research laboratories. Further, in contrast to the formal exchanges between the public culture collections, where a tracking system with unique numerical identifiers has been put into place and recorded in the public catalogues, the informal exchange networks do not allow transparent and systematic tracking to occur. Finally, possible access and use restrictions can be easily imposed by the individual providers of the materials, who transfer the material under a verbal agreement which often includes restriction of use to the host laboratory only (Dedeurwaerdere et al. 2009).

Theoretical models of global scientific research collaboration with basic research assets The culture collections typically distribute their microbial materials as assets that are publicly available under non-exclusive property rights conditions, both under the formal and the informal institutional arrangement. The economic theory of public goods provision, however, highlights major collective action challenges for organizing such collaborations with basic research assets on a global scale. Two core arguments show potential difficulties for the long-term sustainability of cooperation in global pools. The first is based on the so-called prisoners’ dilemma, which shows that, without clear guarantees on the other players’ cooperative behaviour, agents will not cooperate spontaneously, even if

Governing pools of microbial genetic resources 229 greater long-term benefit could be achieved from cooperation (Ostrom 1998). A classic example of this dilemma is the harvesting of wild living resources. Even if all players would be better off if the resources were sustainably harvested, the public good (conservation of the resource) is not produced because of the myopic behaviour of the individual actors. The second argument is based on the free-rider problem in public good provision, which shows that without enforcement measures, some people will attempt to benefit from public goods without contributing, as it is publicly available once it is produced by others (Sandler 2004). As a result, even if some level of cooperation is achieved, the overall provision of the public good will be less than would be the case if all the players contributed in a fair and equitable manner. A conventional solution to these problems is to introduce an external state authority that imposes general-interest and long-term objectives on individuals that otherwise only follow the maximization of their personal self-interest in the short term (Hardin 1968). For the organization of global research commons, this would imply creating a global authority through a multilateral agreement with jurisdiction over the scientific research assets that would act as an external rule enforcer (cf. model 1 in Figure 1). Important examples of such a solution are the International Treaty on Plant Genetic Resources for Food and Agriculture and the Global Influenza Surveillance and Response System discussed above. Whenever such a global state authority is not available, the obvious alternative solution under the conventional approach is to revert to private appropriation of the research assets under exclusive access regimes (Hardin 1968) and organize collaboration on market-based principles only (cf. model 3 in Figure 1). In such a market-based perspective, global research infrastructures can be formed spontaneously based on voluntary initiatives pursuing monetary profit. An example of the latter is global patent pools in which agreements are made by the patent holders to license the use of the patented technologies to each other (Van Overwalle 2009). These global state-like or global market-like solutions for organizing global collaborative research should, however, not be regarded as the only possible institutional models. In particular, these two solutions do not seem to adequately reflect the research collaborations amongst the culture collections reviewed above, which are sustainable even in the absence of exclusive access regimes or the presence of a global external state-like authority. Indeed, many essential knowledge assets for scientific research in microbiology are also made available under non-exclusive use conditions, but are governed by non-state collective actors that share these resources on a non-exclusive basis. As shown in the literature on the governance of the commons, such non-state governance mechanisms are not based on profit-making incentives alone or on external regulation, but are driven in addition by social motivations and personal values (Benkler 2006; Dedeurwaerdere 2012).

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Figure 11.1 Theoretical models of global scientific research collaboration with basic research assets

In the context of scientific research, systematic research on generic design principles for the governance of knowledge commons has allowed identification of a set of more specific design principles of successful governance arrangements by non-state collective actors or hybrid state/ non-state mechanisms. This research has shown that in knowledge commons, participants are driven to a larger extent by reputational and social identity-related motivations along with intrinsic motivations related to the scientific research ethos. As a consequence, collective decision making in social networks will be important for successfully providing knowledge goods on a non-exclusive basis (Benkler 2006), along with collective rules signalling trusted knowledge providers in the hybrid economies that underlie many open access communities on the internet (Lessing 2008). Even though commons-based innovation has proven to provide important social benefits, it is also important to underline that the commons-based economies are not panaceas that can solve all the problems that have been encountered in attempts to build global research infrastructures for research into biodiversity and environmental issues more generally (Hess and Ostrom 2006). Knowledge commons has its own set of governance failures, such as the problem of quality management, sustainable funding and community involvement. Moreover, the costs and benefits of commons-based governance mechanisms should be assessed critically in comparison to other possible governance mechanisms based on the market and state-based models.

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The lesson that can be drawn from the contemporary research on knowledge commons for global biodiversity research is therefore twofold. First, it has been shown that in commons-based institutions, institutional rules for addressing problems of free-riding and for dealing with opportunistic self-interested behaviour can be established in an effective and robust way, even in the absence of external rule enforcement by the state. Further, from a broader social perspective, such commons-based institutions are only a means to realize socially desirable ends and not ends in themselves and need to be compared with other possible means such as markets and state. Finally, as with any institutional tool, realizing the social benefits through commons-based institutions will depend on the organization of effective collective decision making processes in the commons-based institutions themselves.

Collective rulemaking in formally established global microbial pools The formally established collaborations between the public culture collections under the umbrella of the World Federation of Culture Collections present a well-documented case for analysing collective rulemaking in a globally organized pool of basic research assets. Since the adoption of the Convention on Biological Diversity (CBD) and the globalization of intellectual property regimes under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement, public culture collections increasingly use formal MTAs for the distribution of microbial materials. These MTAs formalize the basic norms and benefits of the historical informal exchange system, along with the new obligations and responsibilities that have arisen in the context of the CBD. These formal MTAs are, however, only a first step in the attempt to build a truly global microbial commons and are also hampered by the wide variety of licence conditions which are currently applied and the lack of transparency in access procedures in developing countries, sometimes involving lengthy delays in obtaining genetic materials (Roa-Rodriguez and Van Dooren 2008; CBD UNEP/CBD/WG-ABS/5/3 2007). Scientists from both developed and developing countries have repeatedly expressed concern about the harm that such administrative burdens may have on basic scientific research (Jinnah and Jungcurt 2009: 465; CBD UNEP/ CBD/ABS/GTLE/1/INF/2 2008a). The main initiative for a more standardized approach to the formalization of the distribution of samples by the culture collections is the standard MTA adopted by the European Culture Collections’ Organisation7 (ECCO), which is a regional network of European culture collections established in 1981. ECCO is comprised of 61 members from 22 European countries. The total holdings of the collections number over 350,000 strains. Membership to ECCO is open to representatives of any

232 Tom Dedeurwaerdere, Arianna Broggiato, Dimitra Manou microbial resource centre that provides a professional public service on demand and without restriction, accepts cultures for deposit, provides catalogues and is housed in countries with microbiological societies affiliated to the Federation of the European Microbiological Societies8 (FEMS). In February 2009, ECCO adopted a core Material Transfer Agreement.9 The main purpose of the agreement is to make biological material from ECCO collections available under the same core conditions, which are to be implemented by ECCO members either as such, or integrated into their own more extended MTAs. Collections do not claim full ownership of their microbial holdings under the ECCO standard agreement. Indeed, the MTA foresees that negotiations over the sharing of benefits in the case of commercial use is organized with the countries of origin and not with the collections, and in case of non-commercial use, the collections do not exercise any restrictions on the use of derivatives, whether they be progeny, unmodified derivatives or modifications of the original material. The ECCO MTA requires the material to be used only for noncommercial purposes. If the recipient wishes to use the material or modifications of the material for commercial purposes, it is the recipient’s responsibility to negotiate the terms of any benefit sharing with the appropriate authority in the country of origin of the material (as indicated by the collection’s documentation) in advance of such use. In principle, the ECCO agreement does not require that the collection be involved in the benefit-sharing negotiations. The ECCO MTA for the commons is the main provision of the viral licence clause. Under this clause, recipients are allowed to transfer the material to third parties involved in legitimate exchanges on condition that they use the same licensing conditions. Legitimate exchange is defined as the transfer of the material between scientists working in the same laboratory or between partners in different institutions collaborating on a defined joint project for non-commercial purposes. This also includes the transfer of material between culture collections for accession purposes, with the intention of creating a common pool of microbial resources amongst these collections. To the best of our knowledge, with the exception of the multilateral system under the International Treaty on Plant Genetic Resources for Food and Agriculture, the ECCO core MTA presents one of the few attempts at a best practice guideline for pooling research assets on a global scale. It predates the Nagoya Protocol and combines the requirements of the science commons and the obligations under Article 15 of the CBD. Moreover, the agreement has been collectively approved, though not all clauses are already implemented by all the ECCO member collections. As will be seen below, the core elements of the ECCO MTA are used by an increasing number of collections, even outside ECCO. The WFCC promotes the use of standard MTAs, with an explicit reference to the

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ECCO core MTA as a possible model, along with the Micro-Organisms Sustainable Use and Access Regulation International Code of Conduct (MOSAICC).10 In practice, many WFCC collections have adopted ECCOlike conditions to a certain extent, as can be seen by the analysis of 48 MTAs of WFCC collections from 25 EU countries and 23 non-EU countries in Table 1. Our analysis shows that most of the MTAs of our sample reflect the ‘public service’ objectives which also characterize the core ECCO MTA: the collections make the materials available without restrictions for all non-commercial uses, and most collections allow commercial use after negotiation with the collection and/or the country of origin. These nonexclusive use conditions for non-commercial research are widely satisfied by all the collections, in spite of their heterogeneous funding structures and institutional nature. In particular, all the collections allow the use of derivatives for non-commercial purposes, including progeny (unmodified descendants) and unmodified derivatives (functional sub-units),11 except for one collection situated in Australia, which only permits use, commercial or non-commercial, for specific applications and fields (i.e. education, food industry, aquaculture industry, etc.) as specified in the MTA, and one in Greece, which requires prior written permission for using derivatives even for research purposes. These uses of derivatives are explicitly permitted by nearly all the collections, in spite of the fact that a substantial number of collections do claim ownership over their microbial holdings (12 collections explicitly state their ownership, situated in the US, Australia, the Czech Republic, France, Germany, Greece, Korea, Morocco, Thailand and the UK; 36 make no mention of ownership in their MTA). Moreover, approximately half of the collections that are members of ECCO have started to adopt the viral licence clause for organizing legitimate exchanges in their formal MTAs for non-commercial use. One non-ECCO collection (the National Center for Genetic Engineering and Biotechnology (BIOTEC) in Thailand) has adopted a similar clause in its MTA. Finally, regarding ABS provisions, most collections mention the need to comply with all relevant national and international legislation in their MTA, but only a few collections explicitly mention the need to negotiate with the countries of origin of the genetic resources in the case of commercial use in their MTAs. It is therefore clear that there is still a very low awareness of the ABS requirements in the culture collections community, a situation which is bound to change with the adoption of the Nagoya Protocol.

234 Tom Dedeurwaerdere, Arianna Broggiato, Dimitra Manou Table 11.1 Analysis of MTA conditions in 48 collections in March 2012 (36 collections with a formal written MTA and 12 collections with general conditions of sale) Descriptive statistics of the sample of 48 collections Level of economic development (i)

Advanced economy (33), Newly Industrialized (8), Emerging and developing economy (7)

Type of organization (ii)

Government and semi-governmental (23), University (20), Not for profit (not universities, not government) (3), Private for profit (2)

Geographical distribution

Europe (26), Asia (14), America (5), Africa (1), Oceania (2)

Number of ECCO member collections

19

Analysis of MTA conditions Redistribution Permitted for legitimate exchange, for other cases permitted after written consent

3

Not permitted except for legitimate exchange, for other cases not permitted

6

Permitted after written consent

14

Not permitted

22

Conditions for commercial use Non-commercial use only

11

Both commercial and non-commercial, but must negotiate with the country of origin for commercial use

5

Both commercial and non-commercial, but must negotiate with the collection and the country of origin for commercial use

4

Both commercial and non-commercial, but must negotiate with the collection for commercial use

26

Use of derivatives – progeny (unmodified descendants) and unmodified derivatives (functional sub-units) May use

46

May use for the applications as specified in the MTA

1

May use after prior written permission

1

Note: WDCM’s ‘private’ category has been interpreted as ‘private non-profit’ and ‘industry’ as ‘private for profit’. For a further analysis of these data and an indepth legal discussion, see Reichman et al. (forthcoming). Source: (i) IMF categories, http://www.imf.org/external/pubs/ft/weo/2011/02/ pdf/text.pdf; (ii) WDCM categories, http://www.wfcc.info/ccinfo/collection

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Promoting benefit sharing in global research pools in the implementation of the Nagoya Protocol The self-regulatory system of microbial commons needs to evolve in the future in order to comply with Article 15 of the Convention on Biological Diversity and the Nagoya Protocol. Even in the case of the collections that have transposed the ECCO core MTA and which are using formal deposit forms under mutually agreed terms in accordance with domestic legislation in provider countries, formal approval of the mutually agreed terms by the recognized national authorities will be required, while other conditions might be additionally required. Moreover, many collections have still not implemented the ABS provisions of the CBD in their MTA. On the other hand, many terms and conditions in the Nagoya Protocol, such as the definition of non-commercial use, simplified access procedures and sharing of non-commercial benefits as they apply to collaboration with basic knowledge aspects still need further clarification. In this context, as argued throughout this chapter, the effective implementation of the Nagoya Protocol’s objective to promote research on biodiversity will depend on safeguarding the facilitated access and non-exclusive use conditions that make such research possible. The objective of the last section of this chapter is to evaluate how and to what extent it is possible to safeguard the basic features of the science commons that govern the relationships between biodiversity scientists, both in developing and developed countries in implementing the Nagoya Protocol, by further building on the formally codified MTAs used in the self-regulatory regime of the microbial commons. The latter will, however, not require a negotiation of an ad hoc international legal instrument for research, which would be costly and of unpredictable result. Instead, as we will argue below, it can be accomplished through the implementation of the provisions related to non-commercial scientific research in the Protocol. Non-commercial research The research community is arguably the stakeholder group most affected by access and benefit sharing under the Convention on Biological Diversity and the Nagoya Protocol: access in almost all cases is undertaken with no commercial intent at the time of access (Buck and Hamilton 2011: 59). For example, it has been demonstrated that at the time that the CBD was close to coming into force (end of 1993), the amount of exchange of plant genetic resources in food and agriculture for public research purposes within the Consultative Group on International Agricultural Research (CGIAR) dropped considerably as a result of the re-affirmation of national sovereignty over genetic resources under the CBD in conjunction with the fear of legal uncertainty over intellectual property rights (Halewood 2010:

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403–436). In response, in order to preserve the global seed exchange network established by the CGIAR, the FAO adopted in 1994 a set of ‘in trust’ agreements, which re-established the confidence between developing and developed countries over the global public nature of the CGIAR resources, combined with a formal mandate to negotiate a specific international instrument to regulate the plant genetic resources for food and agriculture. As stated above, scientists in other fields of research have also repeatedly expressed concerns about the harm that restrictive access regulations might have on research. These potentially negative impacts of the CBD on science made the scientific community push for a simplified procedure for scientists accessing genetic resources for non-commercial purposes under the international ABS regime in order to avoid burdens and obstacles. At the same time, many parties were concerned that special treatment of research could create loopholes in the system of ABS compliance to the detriment of parties providing genetic resources (Buck and Hamilton 2011: 59; Kamau et al. 2010: 256). The result of these conflicting interests is the compromise reached in Article 8(a): In the development and implementation of its access and benefitsharing legislation or regulatory requirements, each Party shall create conditions to promote and encourage research which contributes to the conservation and sustainable use of biological diversity, particularly in developing countries, including through simplified measures on access for non-commercial research purposes, taking into account the need to address a change of intent for such research. The rationale of Article 8(a) of the Nagoya Protocol is to create legislative conditions to promote and encourage research which contributes to conservation and sustainable use of biological diversity, that is, to the first and second objective of the Convention on Biological Diversity. To this end, Article 8(a) singles out the adoption of simplified measures to access GRs for non-commercial purposes as a tool to promote and encourage this research. Other tools are also possible, but ABS legislation in provider countries that are parties to the Protocol shall provide for simplified measures to access GRs for non-commercial research that contribute to conservation and sustainable use of biological diversity. Moreover, such simplified procedures need to take into account and define the issue of ‘change of intent’ from non-commercial to commercial purpose at a later stage in the research cycle. Nevertheless, some crucial concepts in this article will still need to be clarified through practice or further legislative development: where does the limit between commercial and noncommercial research lay? What is the scope of research that is aimed at the conservation and sustainable development of biodiversity? How will the ‘change of intent’ be defined in the access legislation? Moreover, Article

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8(a) does not explicitly deal with the administrative and policy measures in the provider country that might lead to additional barriers for access for non-commercial research. Non-commercial research is usually understood as publicly available, determined by non-commercial intentions and not generating monetary benefits for profit or personal gain, while commercial research is characterized by restrictive access, generating market products, benefiting the users and generating monetary benefits (CBD UNEP/CBD/ABS/ GTLE/1/INF/2 2008a; CBD UNEP/CBD/WG-ABS/7/2 2008b). For the purpose of the analysis of the regulation of the scientific research commons under the Nagoya Protocol, we contrast two options for defining utilization for non-commercial research and discuss the implications of these two options for the scientific research commons. A first option is to consider all research activities that are in the exploratory phase of research as non-commercial utilization, which is defined here as all research activities that do not involve the sale of a GR, its components or derivatives for profit purposes, and whose research results remain in the public domain. Both basic and applied research activities, research and development, and research on subsequent applications would fall under such a definition. Any exercise of exclusive ownership rights, such as intellectual property rights, would be considered as commercial utilization under the first option, as this would take the research results out of the public domain. Therefore, under this option, non-commercial research would cover research with materials and their components, including the genetic components, only on condition that no exclusive ownership rights are claimed on these materials and components as a way to foster unrestricted access, use and re-use of these materials during the exploratory phase of research, which is in line with the aim of the article. An example of such an approach can be found in the national legislation of South Africa (Coolsaet et al. 2012). In 2009, the South African Government amended its 2004 Biodiversity Act and introduced a distinction between the ‘discovery phase’ and the ‘commercialization phase’ of bioprospecting. As such, this amendment acknowledges the unpredictability of the scientific process and allows for benefit-sharing agreements to be made at a later stage in the research process once results are clearer and potential value is easier to asses. The ‘discovery phase’ now only requires a notification to be made to the relevant minister, while prospective ‘commercial users’ need to apply for a permit linked to a benefit-sharing agreement before entering the ‘commercialization phase.’12 The public domain conditions considered in the first option are typically satisfied in the case of publicly accessible gene banks for plant, microbial or animal genetic resources, which are directly funded by the government or are maintained as public research infrastructures for

238 Tom Dedeurwaerdere, Arianna Broggiato, Dimitra Manou depositing materials or data related to the scholarly publication process. One example analysed in this chapter is the case of the public microbial culture collections that are members of the World Federation for Culture Collections, which are formally organized to acquire, conserve and distribute microorganisms and information about them to foster public research and education, as described above. Another example, in the field of data, is the International Nucleotide Sequence Database Collaboration (INSDC or Genbank/EBI/NDBJ), which stores all the genetic sequences that have to be deposited prior to any scholarly publication on that sequence on a public database. A second option would be to consider only the research activities at the stage of basic research as utilization of genetic resources for non-commercial research, which would generate no monetary benefits for profit or personal gain (such as through the sale of services for example), and whose research results remain in the public domain. Activities at the research and development stage and activities leading to the development of subsequent applications are considered as commercial under this option. Basic research activities conducted in a private company would also be excluded from noncommercial utilization under the second option. Many of the options proposed or adopted for the implementation of Article 8(a) are a variation or a combination of these two basic options (Coolsaet et al. 2012). For example, in Brazil, the Genetic Heritage Management Council (CGEN), responsible for granting access to the country’s GR, established a list of the types of research and scientific activities exempted for access requirements (Santilli 2009). In Australia, access for non-commercial purposes such as taxonomy is free, while the permit fee for commercial purposes is 50 AUD (Burton 2009). In Costa Rica, biodiversity-related research conducted in public universities has been left out of the ABS law’s scope, except if it has commercial purposes.13 However, not all of these combinations of the options used for defining the notion of non-commercial research would allow preserving the practices of the microbial collections that were surveyed above. In particular, under option 2 described above, any distribution for purposes other than basic research of material that was legally acquired from a provider country would not fall under non-commercial use and therefore require re-negotiating the mutually agreed terms with the provider country, even if there is no intention to commercialize the GR itself, its components or derivatives. This would also apply to the utilization of genetic sequence data at the research and development stage, even for sequences that would have been deposited on a public database. In contrast, under option 1, such downstream uses under public-domain-like conditions would be allowed and considered as part of the exploratory phase of research. Some of the existing practices within the scientific research commons already share, on an informal basis, the rationale of our first option for

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defining the non-commercial use provision of the Nagoya Protocol. On the one hand, the survey of the collections shows that under current circumstances, only a limited number of researchers from the provider countries ask for restrictions on the downstream uses of the deposited materials, and this is also confirmed in the microbial sector in cases of developing countries: about 80–100 per cent of the acquisitions in the surveyed collections came without any conditions. Furthermore, the collections promote rapid and easy access to GRs for research purposes while organizing non-commercial benefit sharing through promoting a global publicly accessible research infrastructure and a set of bilateral capacity building efforts with developing country collections. However, such benefit sharing has not been established under formal mutually agreed terms in the contract of the Nagoya Protocol. Therefore, a further formalization of these arrangements is needed. In this context, the main contribution of the Nagoya Protocol’s provision14 on simplified procedure to access materials for non-commercial purposes is that it can potentially clarify under what non-commercial use conditions facilitated access would be granted when further specified in national legislation. However, in order for the Nagoya Protocol and the scientific research commons to be mutually supportive, the implementation of a properly simplified access procedure for noncommercial research15, though certainly an important building block, will not be sufficient if it only covers the set of activities contemplated under Article 8(a), that is the activities in the scientific research commons that contribute to biodiversity conservation and sustainable use. An additional option for governing the research commons under the Nagoya Protocol would therefore be to implement the facilitated access procedure for all non-commercial research with GR, not only limited to biodiversity research, combined with a set of up-front non-monetary and monetary benefits, such as support for capacity building for research with the GR in the provider country, preferential access for the provider country to the research results and to the genetic material conserved in ex situ collections, training with bio-informatic tools for the use of the information on genetic sequence databases and the provision of technical services. Possible future research-related developments of the Nagoya Protocol The Nagoya Protocol contains possible future scenarios16 for collaboration on the management of genetic resources and for benefit sharing, which might possibly also apply to some areas of activities of the research commons. The Protocol obliges the parties to consider the need for modalities of a global, multilateral benefit-sharing mechanism to address the fair and equitable sharing of benefits derived from the utilization of genetic resources and traditional knowledge associated with genetic

240 Tom Dedeurwaerdere, Arianna Broggiato, Dimitra Manou resources that occur in transboundary situations or for which it is not possible to grant or obtain prior informed consent.17 Moreover, the Protocol prescribes an obligation to collaborate in cases where the same genetic resources are found in situ within the territory of more than one party with a view to implementing the Protocol.18 Global multilateral benefit-sharing mechanism The language of the Protocol when referring to the global multilateral benefit-sharing mechanism is very vague, the result of a compromise: the African Group advocated for the inclusion of pre-CBD materials and areas beyond national jurisdiction inside the scope of the Protocol and ultimately this provision19 was proposed as a compromise by the Japanese COP10 Presidency and not negotiated. The Protocol20 provides for a procedural obligation on the parties to ‘consider the need for and modalities of a global multilateral benefitsharing mechanism’ (Buck and Hamilton 2011: 59) and not for a compulsory setting-up of such a mechanism. The potential mechanism would therefore be only voluntary and complementary to the Nagoya Protocol. Moreover, it would be multilateral, not bilateral. The crucial issue of this provision of the Protocol is sovereignty: it focuses on cases where sovereignty is not clear or is difficult to address. Therefore, in order to avoid excessive costs of monitoring, a global mechanism is to be established in the future. The scope of this provision covers ‘utilization of genetic resources and traditional knowledge associated with genetic resources that occur in transboundary situations or for which it is not possible to grant or obtain prior informed consent’. The scope might be interpreted narrowly or in a wider sense. In the wider sense, it might re-open the issue of the temporal or geographical scope of the Protocol; in the narrow sense it could address materials in ex situ collections that were collected after the Convention on Biological Diversity came into force but before the Nagoya Protocol did so, for example (Buck and Hamilton 2011: 60). It is important to underline that the benefits shared through this mechanism shall be used to support the conservation of biological diversity and the sustainable use of its components globally. This means that the benefit sharing is not going to the provider or providers. This could represent a disincentive for countries to build up such a mechanism. The very first reflections on this mechanism at the informal meeting ‘First Reflection Meeting on the Global Multilateral Benefit-Sharing Mechanism’ in June 2011, did not find any agreement on two basic questions: Is the mechanism needed? And how will it be articulated? However, a consistent opinion was expressed in favour of a step-by-step approach to build up a flexible instrument. Agreement was expressed in recognizing that the mechanism is meant to be complementary to the

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prior informed consent/mutually agreed terms (PIC/MAT) system and not an alternative to it (Tvedt 2011).21. Transboundary cooperation The Nagoya Protocol22 prescribes for collaboration in cases where the same genetic resources are found in situ within the territory of more than one party with a view to implementing the Protocol. As in case of the provision on the global multilateral benefit-sharing mechanism, the language is vague and not defined: there is no definition of what the ‘same genetic resources’ means. In the context of scientific research commons, the case of the same genetic resource found in two countries would be the case of plants only (characterized by great genetic stability), and not of microbial strains (most strains within the same species are not exactly the same and small genetic differences lead to different properties, due to the relatively small size of the genome of a microbe) and animals (different individuals within a breed). Therefore, the article probably also has a very restrictive scope on the design of access agreements for research purposes. In the case of the global multilateral benefit-sharing mechanism, benefit sharing does not go to the individual country, while in the case of transboundary cooperation, the issue is left open. If, as in the case of the multilateral mechanism, the benefits were distributed for global biodiversity protection, this would probably decrease the incentive of countries to start negotiating the further details of the provision of the Nagoya Protocol prescribing for cooperation in transboundary situations of access to and utilization of genetic resources. Best practices, guidelines and standards in relation to access and benefit-sharing agreements for research with public knowledge assets A possible contribution, based on Article 20 of the Nagoya Protocol, would be to further strengthen our proposition for a broad interpretation of the notion of non-commercial research under Article 8(a), by exploiting the role given by the Nagoya Protocol23 to state parties to encourage, develop and use guidelines and best practices. Such recognized best practices could give additional support to this proposition by agreeing amongst stakeholders on standardized licence conditions for access to genetic resources for research purposes under mutually agreed terms, which could contribute to the periodical stock-taking by the Conference of the Parties.24 Best practices could, for example, specify a minimal set of clauses to be included in the contracts, while leaving sufficient flexibility to adapt a contract to the various research specific contexts.

242 Tom Dedeurwaerdere, Arianna Broggiato, Dimitra Manou

Conclusion This chapter has addressed the institutional design of knowledge pools for scientific research on a global scale. The analysis showed that, in contrast to conventional economic theory, which would predict the proliferation of restrictive access regimes based on the exercise of national sovereignty, global scientific research commons are widespread, especially for research in the upstream dimension of the research cycle. This is in line with some frontier research on the scientific research commons, which shows that social motivations, personal values and reciprocity benefits are the main incentives that drive the scientists that work in international scientific cooperation for basic research (Reichman et al. forthcoming). The adoption of the Nagoya Protocol on 29 October 2010 opened new opportunities for further consolidating the emerging legal frameworks for global collaboration with basic research assets: the Protocol further strengthens the importance accorded to mechanisms of non-monetary benefit sharing for collaborations involving research assets in the upstream dimension of the research cycle, while recognizing the need for more standardized contractual arrangements to deal with benefit sharing in the case of commercial use. These non-commercial benefit-sharing arrangements are already the bases of scientific collaboration in the microbiological sector as described in this chapter. Therefore, the realization of these opportunities will largely depend on the appropriate institutional fit between the implementation of the Protocol and the norms and practices of the science communities that govern successful global research collaborations. To illustrate these challenges, the chapter presented empirical research results on global pools in the specific field of microbiology, both in informal pools of exchanges of materials between in-house culture collections and the formally organized pools of public culture collections. As shown, through our analysis of a set of 48 material transfer agreements of public service culture collections from 24 different countries, a contractual system of legitimate exchange amongst the collections is emerging and can lay the foundations for the further development of a code of conduct which addresses both the needs of global scientific research into biodiversity and the requirements of the access and benefit-sharing regime.

Notes 1

2

Non-commercial research is usually understood as publicly available, determined by non-commercial intentions and not generating monetary benefits for profit or personal gain, while commercial research is characterized by restrictive access, generating market products, benefiting users and generating monetary benefits (CBD UNEP/CBD/ABS/GTLE/1/INF/2 2008a). ‘Open sesame’ (2012).

Governing pools of microbial genetic resources 3 4 5 6 7 8 9 10 11

12 13 14 15 16 17 18 19 20 21 22 23 24

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International Nucleotide Sequence Database Collaboration website, http:// www.insdc.org, viewed 10 May 2012. The WHO Global Influenza Surveillance and Response System (GISRS) website, http://www.who.int/gho/epidemic_diseases/influenza/virological_ surveillance/en/index.html, viewed 10 May 2012. For more details, see Chapter 16. For instance, costs related to negotiations to be undertaken, contracts to be drawn up, inspections to be made, arrangements to be made to settle disputes, and so on (Coase 1960: 1–44). European Culture Collections’ Organisation (ECCO) website, www.eccosite. org, viewed: 10 May 2012. Federation of the European Microbiological Societies website, http://www. fems-microbiology.org/website/nl/default.asp, viewed 10 May 2012. The text is available at http://www.eccosite.org/MTA_core.html, viewed 10 May 2012. World Federation for Culture Collections – Guidelines for the establishment and operation of collections of cultures of microorganisms, 3rd edition, February 2010, principle 9.5, http://www.wfcc.info/guidelines, viewed 23 January 2013. The question of modifications has to be assessed individually for each collection, as there is too much heterogeneity in language between the collections. For example, ATCC explicitly states that the purchaser retains ownership of modifications. However, ATTC’s licence is for non-commercial use only, so the purchaser has to obtain a written agreement from ATCC before using these modifications for commercial purposes. Other collections, such as the University of Köln’s (CCAC), state that the recipient may use the modifications for commercial purposes after negotiation, without clarifying the ownership rights on the modifications. Sections 29, 38 and 39 of the National Environment Laws Amendment Act, Government Gazette No. 14 of 2009, Republic of South Africa. Article 4 of the Biodiversity Law, No. 7788, Legislative Assembly of the Republic of Costa Rica, 30 April 1998. Article 8(a) of the Nagoya Protocol. Ibid. Articles 10 and 11 of the Nagoya Protocol. Article 10 of the Nagoya Protocol. Article 11 of the Nagoya Protocol. Article 10 of the Nagoya Protocol. Ibid. http://www.fni.no/abs/publication-47.html, viewed 10 May 2012. Article 11.1 of the Nagoya Protocol. Article 20.1 of the Nagoya Protocol. Article 20.2 of the Nagoya Protocol.

References Antarctic Treaty (1959) UNTS vol. 402. Benkler, Y (2006) The wealth of networks: how social production transforms markets and freedom, Yale University Press, New Haven. Biodiversity Law No. 7788, Legislative Assembly of the Republic of Costa Rica, 30 April 1998. Buck, M and Hamilton, C (2011) ‘The Nagoya Protocol on Access to Genetic Resources and the fair and equitable sharing of benefits arising from their

244 Tom Dedeurwaerdere, Arianna Broggiato, Dimitra Manou utilization to the Convention on Biological Diversity’, Review of European Community & International Environmental Law, 20, 47–61. Burton, G (2009) ‘Australian ABS law and administration. A model law approach?’, in Kamau E and Winter G (eds), Genetic resources, traditional knowledge and the law. Solutions for access and benefit sharing, Earthscan, London. CBD (2007) Report of the ad-hoc open ended Working Group on Access and Benefit-Sharing ‘Analysis of gaps in existing national, regional and international legal and other instruments relating to access and benefitsharing’, UNEP/CBD/WG-ABS/5/3. CBD (2008a) Report of the Group of Legal and Technical Experts on Concepts, Terms, Working Definitions and Sectoral Approaches, ‘Concepts, terms, working definitions and sectoral approaches relating to the international regime on access and benefit-sharing’, Submission from the international workshop on the topic of ‘Access and benefit-sharing in non commercial biodiversity research’, Bonn, 17–19 November, UNEP/CBD/ABS/GTLE/1/ INF/2. CBD (2008b) Report of the Meeting of the Group of Legal and Technical Experts on Concepts, Terms, Working Definitions and Sectoral Approaches, UN Doc. UNEP/CBD/WG-ABS/7/2. Coase R (1960) ‘The problem of social cost’, Journal of Law and Economics, 3, 1–44. Convention on Biological Diversity (Rio, 5 June 1992, in force on 29 December 1993), UNTS, vol. 1760, p. 79. Coolsaet, B, Batur, F, Pitseys, J, Van den Bossche, K and Dedeurwaerdere, T (2012) Study for the implementation in Belgium of the Nagoya Protocol on Access and Benefit Sharing to the Convention on Biological Diversity. Final report for the Federal Public Service for Health, Food Chain Safety and the Environment, Belgium, Unpublished. Dawyndt, P, Dedeurwaerdere, T and Swings, J (2006) ’Exploring and exploiting microbiological commons: contributions of bioinformatics and intellectual property rights in sharing biological information. Introduction to the special issue on the microbiological commons’, International Social Science Journal, 188, 249–258. Dedeurwaerdere, T (2012) ‘Design principles of successful genetic resource commons for food and agriculture’, International Journal of Ecological Economics and Statistics, 26 (3), 16–30. Dedeurwaerdere, T, Iglesias, M, Weiland, S and Halewood, M (2009) ‘Use and exchange of microbial genetic resources relevant for food and agriculture,’ CGRFA Background Study Paper no. 46, Commission on Genetic Resources for Food and Agriculture, Rome. Halewood, M (2010) ‘Governing the management and use of pooled microbial genetic resources: lessons from the global crop commons’, International Journal of the Commons, 4 (1), 403–436. Hardin, G (1968) ‘The tragedy of the commons’, Science, 162 (3859), 1243–1248. Hess, C and Ostrom, E (2006) Understanding knowledge as a commons: from theory to practice, MIT Press, Cambridge, MA. International Treaty on Plant Genetic Resources for Food and Agriculture, FAO Res. 3/2003, 3 November 2001, UNTS vol. 2400, p. 379. Jinnah, S and Jungcurt, S (2009) ‘Could access requirements stifle your research?’, Science, 323 (5913), 464–465.

Governing pools of microbial genetic resources 245 Kamau, E, Fedder, B and Winter, G (2010) ‘The Nagoya Protocol on Access to Genetic Resources and Benefit Sharing: what is new and what are the implications for provider and user countries and the scientific community?’, Law, Environment and Development Journal, 6 (3), 246. Lessig, L (2008) Remix: making art and commerce thrive in the hybrid economy, Penguin Press, New York. Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from Their Utilization to the Convention on Biological Diversity, Nagoya, Japan, 29 October 2010. National Environment Laws Amendment Act (2009) Government Gazette No. 14 of 2009, Republic of South Africa. ‘Open sesame: when research is funded by the taxpayer or by charities, the results should be available to all without charge’, The Economist (14 April 2012), http:// www.economist.com/node/21552574, viewed 15 May 2012. Ostrom, E (1998) ‘A behavioral approach to the rational choice theory of collective action: presidential address, American Political Science Association’, The American Political Science Review, 92 (1), 1–22. Reichman, JH and Okediji, RL (2009) ‘Empowering digitally integrated scientific research: the pivotal role of copyright law’s limitations and exceptions’, Paper presented at the Conference of the Engelberg Center on Innovation Law & Policy, and Max Planck Institute for Intellectual Property, Competition and Tax Law, ‘Enough is enough!: Ceilings on intellectual property rights workshop’, NYU School of Law, 1–2 May. Reichman, JH, Dedeurwaerdere, T and Uhlir, P (forthcoming) Global intellectual property strategies for the microbial commons, Cambridge University Press, Cambridge. Rio Declaration on Environment and Development (1992) UN Doc. A/ CONF.151/26/REV.1, vol. 1. Roa-Rodriguez, C and Van Dooren, T (2008) ‘Shifting common spaces of plant genetic resources in the international regulation of property’, The Journal of World Intellectual Property, 11 (3), 176–202. Sandler, T (2004) Global collective action, Cambridge University Press, Cambridge. Santilli, J (2009) ‘Brazil’s experience in implementing its ABS Regime – suggestions for reform and relationship with the International Treaty on Plant Genetic Resources for Food and Agriculture’, in Kamau E and Winter G (eds), Genetic resources, traditional knowledge and the law. Solutions for access and benefit sharing, Earthscan, London, pp. 187–202. Tvedt, MW (2011) A report from the first reflection meeting on the global multilateral benefit-sharing mechanism, Fridjtof Nansen Institute, Oslo, http://www.fni.no/ abs/publication-47.html, viewed 10 May 2012. UN (1972) Declaration of the UN Conference on the Human Environment (‘Stockholm Declaration’) UN Doc. A/CONF/48/14/REV.1. UNCLOS (United Nations Convention on the Law of the Sea) (10 December 1982, Montego Bay), UNTS, vol. 1833, p. 397. Van Overwalle, G (ed.) (2009) Gene patents and collaborative licensing models: patent pools, clearinghouses, open source models and liability regimes, Cambridge University Press, Cambridge. World Federation for Culture Collections (2010) ‘Guidelines for the establishment and operation of collections of cultures of microorganisms’, 3rd edition, February, http://www.wfcc.info/guidelines, viewed 23 January 2013.

12 Networks of ex situ collections of genetic resources Christine Godt

Introduction Ex situ collections play a central role in the preservation and research of biodiversity as they store biodiversity in a nutshell. Whereas plant, animal, microbe (from yeasts or bacteria to viruses) collections do not directly contribute to conservation in situ, they serve a central function in research and contribute indirectly to conservation by (1) substituting the accession in situ, (2) securing a double set in case of loss and destruction of single cultures, (3) educating botanists and biology teachers, (4) contributing to scientific research, such as taxonomy, evolution, genetics, botany, chemical and proto-pharmaceutical analysis, (5) providing environmental education to the public, (6) offering recreation to the public in areas which are close to natural environments, thus also contributing to the appreciation of nature. In addition, collections serve a central goal in industrial research and development (R&D) based on biological resources. Article 9 of the Convention on Biological Diversity (CBD) includes ex situ collections within its scope. This is undisputed for accessions subsequent to the CBD coming into force; discussions continue about whether the collections are ‘providers’ or ‘users’. Whereas self-descriptions often refer to their intermediary function, their status in legal terms depends on the service they provide. Whereas collections in provider states are often charged with regulatory provider state duties (e.g. Ethiopian Institute of Biodiversity Conservation1), collections located in user countries more often than not provide services to users and/or to user countries’ governments. The current chapter focuses exclusively on collections in user states. The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization (NP) has an even stronger focus on user countries’ ex situ collections as Article 15 NP stipulates that genetic resources ‘utilized’ (defined by Article 2 (c) NP as ‘research and development’) within its jurisdiction have to comply with the rules of the other party (the provider state), which secure its prior informed consent (PIC) and access on mutually agreed terms (MAT).2 It has also refuelled the long-lasting debate

Networks of ex situ collections of GR 247 about the temporal coverage (retro-activity) if continuous possessions and new forms of utilization of pre-CBD material fall under the scope of the CBD.3 This question, however, is not at the heart of this chapter because it departs from the current practice of collections not to distinguish pre- and post CBD-material.4 Article 4 NP stipulates that parties shall not be prevented from developing and implementing more specialized ABS agreements, instruments and practices. According to common understanding, these ‘specialized instruments’ are ex situ collections regimes which have been developed in various sectors (from horticultural to food and agricultural, and from zoological and archaeological to the environment and the health care sector), on various levels of governance, each responding to specific needs. Important ex situ collections are ‘public’ (non-commercial) and pursue various sorts of public access and network policies. Overall, they have been recognized as responding to the market failure of underinvestment in public goods (Dedeurwaerdere 2010; Uhlir 2011). Their various forms of open access policies have been challenged inter alia by the CBD rationale. Responding both to CBD compliance claims and the wish to maintain open exchange structures, they devised alternative exchange structures which have been incorporated within the NP. This chapter, however, asks the question: under which conditions do these ‘specialized instruments’ deserve to be accepted as ‘tailor-made ABS solutions’ that allow a deviation from the general NP regime? The chapter concentrates on three ‘common pools’ (ex situ collections) in three sectors: horticulture, microbiology and agriculture.5 They all claim a model function for their respective sector in that they comply with the CBD rules (facilitate access, contribute to fair and equitable benefit sharing, and continue to share and exchange genetic material). However, they differ distinctly in their governance and their rules. The horticultural common pool is the International Plant Exchange Network (IPEN) of some botanical gardens, mainly a grass-root initiative (as ‘self-governance’). The chosen microbial collection is the National German Collection of Microorganisms and Cell Cultures (DSMZ) in Braunschweig,6 a member of the European Culture Collections’ Organisation (ECCO) and the World Federation of Culture Collections (WFCC). DSMZ defines itself as a ‘service provider’ for scientists, industry and government alike. It is run as a private company limited by shares under German company law (GmbH). Its shares are owned by the federal state Lower Saxony, and since it is acknowledged as an international depositary authority (IDA) under the Budapest Treaty, quality control is also secured by the Research Ministry of the federal government. The flagship common pool in the agricultural sector is the Multilateral Regime under the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA), an international treaty administered by the Food and Agriculture Organization of the United Nations (FAO), under which auspices member states pool their collections. The pool is illustrated

248 Christine Godt by the example of the German Leibniz Institut für Pflanzengenetik und Kulturpflanzenforschung (IPK) in Gatersleben. The chapter will first present an overview of ex situ collections and a matrix of characteristics, followed by a detailed description of the three selected collections. The analysis that follows will look into their privileged status as ‘specialized instruments’ by examining their ABS performance, their function to their constituencies, and the ‘pool rationale’. The chapter ends with some conclusions.

The landscape of ex situ collections and the analytic choice The global wealth of ex situ collections cannot easily be categorized. Superficially, they can be distinguished according to the collected material. Whereas all collections of plants (forests, horticulture, staple crops – including fruits, vegetables and grains)7, animals (livestock, fish and agents of biological control (Schloen et al. 2011: 11) and microbes (including bacteria and viruses) are covered by the CBD ABS regime, collections of human tissue and blood are not (Article 2 CBD). Another important category is their purpose. Some collections serve a purely academic research purpose (universities); others pursue a public education mission, often combined with long-term storage tasks and/or research (museums); others pursue primarily administrative purposes (depositories for safety or patent records); others again are directed towards commercial research and development. Another more or less pertinent category is public versus private. Public collections are engaged in making the collections accessible for the broader public8 and struggle with the CBD requirements of access and benefit sharing.9 Although collections often cannot neatly be attributed to a specific industrial sector, they are, for organizational reasons, assigned to various supervising agencies. For example, the Leibniz Institut für Pflanzengenetik und Kulturpflanzenforschung (IPK) in Gatersleben, Germany is supervised by the Agricultural Ministry. Collections of viruses and bacteria are submitted to the Veterinary Department and to the Department of Health.10 Botanical gardens are mostly submitted to environmental administrations. Collections can also be distinguished along the scientific method they pursue. Some collections focus on the biological resource, others on the genetic information. Some collections are interested in genetic resources for their biological or chemical material, some digitalize the genome in data banks.11 An important distinction, not only for scientific reasons, is if a collection collects propagating (living) or nonpropagating (e.g. paleontological) material: collections with living, propagating material depend on access to fresh, natural material. More importantly, with regard to the CBD rationale, the material necessarily changes over time (either via sexual crossing, due to environmental pressures, or by death) with ramifications for traceability12, and the

Networks of ex situ collections of GR 249 ‘genetic proximity’ of the ex situ collection to the originally accessed material. A rough distinction qualifies them as either ‘public’ or ‘private’. This distinction can refer to the incorporate form (private ownership vs. state property), or to their primary source of funding (private donations/ foundations, commercial collections or public funding, such as most universities and museums). It can also refer to their tax status as being either ‘for profit’ (private13) or ‘non-profit’ (public, like the private nonprofit research organizations CAMBIA, DArT). More important, however, is the question of how access rules are designed: as ‘public’ or as ‘exclusionary’. Most corporate collections are treated as ‘treasure boxes’ to which no access is granted (an interesting exception is the SNP consortium (Godt 2007: 179)). The meaning of ‘public access’ is, in principle, access by everyone. That implies neither that all governmental collections grant public access, nor that access can be limited to professionals of the community (most university and national scientific collections) or conditioned to professional skills (DSMZ). Yet, ‘common pools’ usually advertise themselves as ‘public access’, referring to the idea that the hosted resources belong to everybody. This chapter concentrates on three distinct types of ‘public access’: the multilateral FAO system of the ITPGRFA, IPEN and WFCC/ECCO microbial collections. Other types of public access in terms of ‘conditioned access’, which range from ‘exclusionary’ to ‘free access to everyone’, are not covered. Therefore, not included are collections which aim to restore the ‘public domain’ (access to everybody on unrestricted terms) by contractual arrangements – projects such as MOSAICS (Desmeth 2007) and research organizations like CAMBIA with its (BiOS)14 initiative (Biological Open Source), or Diversity Arrays Technology (DArT) Proprietary Ltd (Kilian 2009). These initiatives build on the Open Source Model which requires recipients of material to subscribe to the ‘copyleft’ clause, allowing for improvements (also patenting) and obliging them to share those on equal terms. It is now well understood that these initiatives do not restore the ‘public domain’ but create a ‘contractual construed commons’ (Reichman and Uhlir 2003), or ‘club commons’ (David 2011: 14), a ‘total, conditional openness, the condition not being monetary remuneration but covenanted sharing behaviour’ (Van Overwalle 2011: 82).15 This book, however, does not focus on access to common pools as such (cf. Uhlir 2011; Dedeurwaerdere 2010; Burk 2009), but on tailor-made regimes which retain public openness while respecting the CBD rationale. Thus the interest is in qualified regimes which allow for a deviation from the narrow bilateral contractual CBD approach. The three chosen regimes have become known for their proactive engagement in complying with the CBD.

250 Christine Godt

A closer look at three common pools ITPGRFA multilateral system The ITPGRFA was agreed upon in 2001 and came into force in 2004. It is administered by the FAO.16 Its goal is to secure access to plant genetic materials for farmers, plant breeders and scientists. It is conceived as sector specific (lex specialis) to the general CBD. It covers member states’ resources in situ as well as national collections ex situ. Germany hosts two major collections covered by the Treaty,17 the Leibniz-Institut für Pflanzengenetik und Kulturpflanzenforschung (IPK) Gatersleben18 and the Julius-Kühn-Institute,19 currently with 13 locations.20 The centrepiece of ITPGRFA is the Multilateral System which submits 64 most important staple crops which account for 80 per cent of all human consumption (including wheat and rice in various collections) to access by everyone.21 Its goal is expeditious access via Standard Material Transfer Agreements (SMTAs). However, the use of SMTAs is restricted to purposes of research, breeding and training. The standard form is not available for chemical, pharmaceutical and/or other non-food/feed industrial uses (Article 12 sec. 1 ITPGRFA). Benefit sharing in the Multilateral System is conceived of in two forms: (1) the primary avenue is free sharing of new developments at no cost for further research (and under the residuary obligations that the duty to share will be transferred to follow-on breeders); (2) however, if receivers want to keep the developments to themselves, they agree to pay a percentage of any commercial benefits they derive from their research into the common fund for the support of conservation and further agricultural development in the developing world. Thus, the ITPGRFA has transformed what was formerly a ‘public domain good’ into a novel category, which (1) secures access to breeders, farmers and individuals in a world of practised genetic patenting, (2) perpetuates the traditional breeders’ freedom to operate, 22 and (3) provides compliance with the CBD in benefit sharing. Essentially, this scheme ‘decouples’ benefit sharing from use. Although the Multilateral System is often referred to as ‘public domain’, it is not in the classical sense for two reasons. First, industrial users are excluded (chemical, pharmaceutical). If they seek access, they have to enter into an individually negotiated contract. Second, often the nonpatentability of material ‘as received’ (Article 12 sec. 3 [d] ITPGRFA) is referred to as securing the ‘public domain’. However, there is no evidence that this rule has broadened the scope of non-patentable subject matter beyond the prior standards of ‘novelty’ and ‘inventive step’.23 The central question of whether isolations and derivatives are patentable is still unresolved.24

Networks of ex situ collections of GR 251 IPEN IPEN is a pool of botanical gardens with 148 member gardens located in 21 countries.25 Two-thirds of them are university collections.26 Founded in 2001, IPEN endorsed a club model aimed at complying with the ABS requirements of the CBD.27 It perceives itself as a pioneering model of a sector-specific, self-regulating pool which has implemented a CBDcompliant, innovative model which keeps the existing exchange structures intact between members.28 IPEN is exclusively accessible to botanical gardens. On average, 58 per cent of plant material in the collections stem from international seed exchanges between collections, and 12 per cent of materials are collected in situ (von den Driesch et al. 2008: 52). Its ultimate goal is to secure access to material, especially in situ in provider states. Its functional core is the easy exchange of material between members, which reduces the paperwork to the indication of the so-called IPEN number. No material transfer agreement (MTA) is required. The system is based on the commitment of members to non-commercial use. If one member brings in a new accession, it ‘clears’ the material for compliance with the domestic access and benefit-sharing rules of the provider state, documents it and assigns a number to the accession. This applies both to situations in which the gardens accessed the material themselves, and where they acquired it via a third party. The IPEN number encodes (1) the provider state, (2) the conditions of access (‘un-conditioned’/’conditioned’), (3) the first accession garden, and (4) the unique (chronological) accession number.29 An example of ‘conditioned access’ (signalled by the number ‘1’ instead of the preferential ‘0’) is, for instance, the provider state’s insistence on documented/notified transfer between member gardens or the prohibition of providing seeds (i.e. vegetative propagation material only). Thus, the number guarantees that ABS rules have been observed. All material ‘within in the system’ should be legally accessed. In this sense, the first accession garden acquires a ‘checkpoint function’ (von den Driesch et al. 2008: 55). It also ensures traceability of material for the provider states. Transfer to third parties requires their disclosure of intentions of either non-commercial or commercial use. Under a commitment of noncommercial use, transfer can happen under an SMTA which transfers all IPEN-agreed MAT to the other party (3.2.3 Code of Conduct). In addition, the SMTA obliges the other party to seek new PIC with the provider state once a use is not covered. Any transfer to commercial undertakings and to users with commercial interests requires that the user negotiates his/her own new and separate agreement with the provider state. Only after a document giving evidence about prior informed consent of the provider state has been submitted, and the other party has agreed that it will obey its bilateral duty to share benefits with the provider state, will transfer be executed under an individualized MTA (3.2.4. Code of Conduct).30 Since

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IPEN only covers non-commercial use, the material used for commercial purposes has to ‘leave’ the system. That means that the material will become ‘re-individualised’. Material inside the system will continue to circulate under the IPEN regime, while the ‘leaving’ material again becomes ‘individual plant material’ for which PIC and MAT have to be negotiated with the provider state as if it were accessed for the first time. Delivery by the garden only substitutes actual access on the territory of the provider state. The same procedure applies when an IPEN member wishes to commercialize its material (or use it in ways not covered by the provider approval): the material will be discarded from the system, as commercial use is only possible ‘outside the system’ (von den Driesch et al. 2008: 54). Sanctions for any breach of these duties, however, are not stipulated by the Code of Conduct. Hence, members depend on other strategies to secure compliance with the rules, e.g. by ‘blaming’ and ‘shaming’ in cases of biopiracy. As various sources have confirmed, in practice no transfer to third parties occurs (despite its theoretical and legal possibility). Scientifically, the biggest treasure is the supplementary documentation. The system distinguishes ‘maximal’ and ‘minimal’ documentation. Whereas the minimal documentation is the IPEN number, supplemented eventually by any use restrictions31 (which follows the plant [so called ‘accession’] through descendants and transfers), the maximal documentation has to be produced by the first IPEN accession garden and whoever wants to transfer the material inside the network. The documentation includes all relevant information like taxonomy, the type of material, the source, the provider state, the nature of permits which might be necessary for the propagation of the material, and, if so, special conditions of the provider state. Whereas the system has been widely adopted in Germany, the IPEN network covers only a small fraction of the global 1,800 botanical gardens.32 Due to its non-commercial commitment, botanical gardens which engage in commercial research are advised also to sign the ‘principles on access and benefit sharing for participating institutions’ which have been devised under the lead of the Royal Botanical gardens of Kew that (historically) proactively promote the utilization of their resources by industry. Kew is not a partner of IPEN. Other major members of the ‘principles’, however, are (apart from Kew) the National Botanic Gardens of Ireland and the Missouri Botanical Garden. Thus, whereas the IPEN system secures smooth exchange between members, the overall effects of the system have remained quite limited. On the one hand, this is due to the limited number of member institutions. On the other hand, the explicit exclusion of any management or reporting on commercial utilization has resulted in very limited influence on the shaping of an equitable regime of benefit sharing. Although IPEN was initially considered to open the system towards use management, the plans were not pursued since gardens feared that provider states would then refrain

Networks of ex situ collections of GR 253 from providing material (Winter and Kamau 2009). Thus, in essence, the system secures the continuation of the specific German (scientific) type of botanical gardens.33 Moreover, additional interests in the ‘scientific and non-commercial commitment’ of botanical gardens support the continuity of the IPEN system. Since many IPEN gardens belong to universities (directors of botanical gardens are often, at the same time, professors at the local university), or engage in very close relations with them, botanical gardens grant access to their collections in the interests of academia. However, actual practices vary: some gardens treat universities as non-member institutions, and therefore apply the same transfer conditions to them and differentiate between non-commercial (SMTA transfer) and commercially oriented research (prior PIC submission required). University IPEN member gardens, however, transfer material to their colleagues in botanist faculties under IPEN terms (no SMTA required) – regardless of the actual context of the pursued research project as purely non-commercial or commercial, and transfer under SMTA to colleagues from pharmacology departments.34 Many universities hold botanical gardens for educational and research purposes. Some may be unaware of potential conflicts between their modern role, which includes technology transfer to industry,35 and the IPEN system. Yet collaboration with IPEN members eases pressure on universities to comply with ABS. Modern universities cannot draw a clear line between non-commercial and commercial research, however much some might wish to restore it (von den Driesch et al. 2008: 55). The modern university has, for various reasons, strengthened its ties to the corporate sector.36 Consequently, there are evident holes in the IPEN system when MTA-free transfer of material to academic research labs is possible (including digital IPEN maximal documentation). Whether the IPEN transfer (without MTA) to the university faculty complies with IPEN statutes is a question that has to be clarified with regard to the organisational structures in each single case. However, for reasons of CBD compliance, it is not irrelevant if the link to the garden is lost when the material entered the lab. Once the research results become patented (which will then be transferred to the commercial sector), it is highly probable that even in cases in which the indication of the country of origin is objectively possible although not mandatory (§ 34a German Patent Code), the indication will not be included in the patent description. WFCC/ECCO microbial collections: DSMZ as an example Central to academic and industrial research alike are microbial ex situ collections (Uhlir 2011a). On a global scale, the most important federation is the World Federation of Culture Collections (WFCC), which is engaged in the collection, authentication, maintenance and

254 Christine Godt distribution of cultures of microorganisms and cultured cells (ECCO as the respective European organization). Its core activity is the development of an international database on culture resources worldwide which records nearly 476 culture collections from 62 countries. Nr. 17.5 und 17.6 WFCC-Guidelines 2010 (3rd)37 stipulate that the transfer of organisms must ascertain both intellectual property and PIC. Accessions are expected to comply with CBD requirements (including PIC and MAT). However, there is neither a depository which secures information, nor a mechanism for double checks. Germany is listed with 13 WFCC collections held either by universities or the government (besides the numerous non-service oriented collections of universities and private corporations).38 The most important WFCC collection is the German Collection of Microorganisms and Cell Cultures (Deutsche Sammlung von Mikroorganismen und Zellkulturen, DSMZ) in Braunschweig,39 incorporated as a limited company (GmbH), owned by the state of Lower Saxony,40 a member of the Leibniz-Gemeinschaft.41 DSMZ is entrusted with three distinct tasks: (1) running an open collection with published catalogues, (2) being in charge of the deposit duties for biological material for patent purposes under the Budapest Treaty42, and (3) providing for a safe deposit for duplicates where access is solely controlled by the depositor. For deposit in the open collection, DSMZ requests disclosure of geographical origin and information about PIC und MAT.43 In this way, DSMZ complies with the WFCC Guidelines, and with modern publication standards which require that the material, for which results are presented, is deposited and publicly accessible for scientists.44 In addition, the transfer is conditioned: transferring material to third parties in order to secure retraceability is prohibited.45 DSMZ informs the recipient that he/she might need to attain PIC and MAT by the country of origin before utilization46 and excludes liability for any violation thereof.47 In contrast, for the patent related deposits, no similar documentation about the geographical origin, PIC and MAT is currently requested.48 Article 5 Budapest Treaty (BT) limits additional requirements to incidents of national security and environmental safety. According to Article 6 sec. 2 subsec. v BT, any material has to be accepted. However, this duty only refers to types of material that have been notified to the secretariat of the Treaty. Thus, the question of whether the collection may request disclosure of geographic origin remains open. One may either argue that additional requirements are not permitted, or that the BT lacks a regulation regarding the source information which can be settled by national legislators. Article 6 sec. 2 vii BT submits the collection to confidentiality. Access is granted via the appropriate patent office, with DSMZ only supplying the strain when they have granted permission. Equally, no information about PIC and MAT is requested for security deposits of duplicates.

Networks of ex situ collections of GR 255 Comparison In contrast to many window-dressing assumptions as to ‘public access’, the primary goal of all three assessed regimes is to secure access to a specific constituency (IPEN: member gardens; ITPGRFA: everybody except industry; DSMZ: scientists and industry). They serve a respective epistemic community (IPEN: botanists and agricultural biologists and geneticists; ITPGRFA: agricultural breeding; DSMZ: biologists). All collections are interlinked in an international network which harmonizes standards, thus securing speedy, quality controlled global exchange. Quality includes the declaration of geographic origin, not necessarily proof of legal access and a contract about benefit sharing. The regulatory structures of these networks are surprisingly loose and function on a collaborative basis: while the agricultural collections are embedded in the international vertical state hierarchy of organisation, they enjoy a great amount of self-governing freedom. The WFCC is a private organization with national member collections, but standards seem to be strict. The Budapest Treaty has some regulatory impact. The network with the weakest organizational scheme is IPEN. All three collections apply basic rules for CBD compliance with ‘incoming material’. As a matter of principle (notwithstanding the two exceptions in DSMZ), none of the collections accept material of uncertain origin/providence (NP). However, while IPEN-numbered material has a ‘cleared ABS status’ (understood as material accessed according to national rules about access and benefit sharing as far as those exist), ITPGRFA and microbial collections do not even ask for a PIC certificate, or a declaration that MAT have been concluded (neither is a declaration that PIC and MAT were not required). What they do, however, is to provide a ‘unique identifier’ to the incoming resource. For material transfer, minimal formalities are required between IPEN members: just the IPEN number suffices. For the transfer to ‘other institutions’, all collections make use of SMTA in order to lower transaction costs. For that reason, they use them for both CBD and non-CBD material (material acquired before 1992, and material not covered by the scope of the CBD), which has caused some fuss about the legal status of the material (for CBD material: expansion of public domain resources; for non-CBD material: restriction of public domain to the SMTA form). However, important differences exist about CBD requirements for the transfer to third parties. DSMZ gives only a hint to the recipient that he/she is responsible for obtaining PIC and MAT if required. For safety reasons, it prohibits any transfer to third parties (not for CBD-enshrined reasons like the dilution or loss of negotiated restrictions). IPEN members, at the other end of the scale, do not provide material to non-members in practice. However, statutes require that if they do, third parties must produce certificates which document PIC and MAT with the provider state. The

256 Christine Godt multilateral system of the ITPGRFA lies ‘in the middle’. It generously provides access to the material to everybody – with two requisites: (1) an MTA was signed either with a copyleft obligation, or a royalty duty to the fund – both to be transferred downstream, (2) the ‘everybody’ are researchers, breeders and farmers, not ‘big industry’ (chemical, pharmaceutical, food). Their own duty to share benefits with provider states has only pale contours. A limited number of IPEN gardens have engaged in attempts to transfer non-monetary benefits like training, repatriation and information sharing (as advised by the Bonn Guidelines, now Annex, No. 2 NP).49 The ITPGRFA’s approach is benefit sharing by ‘share alike’ (royalties come second). Microbial collections, like DSMZ, put all responsibility on the recipient. As a matter of principle, they reject their own qualification as ‘users’, therefore denying their own duties in benefit sharing. Overall, the collections’ aim is to avoid benefit sharing.

‘Specialized instruments’ under Article 4 NP? The question must be raised whether the three examined regimes can claim preferential status as a ‘specialized instrument’ under Article 4 NP, which justifies deviations from the general ABS rules. The direct applicability of the NP to ex situ collections in general is not quite clear. Yet it is undisputed that Article 4 NP (especially the exemption of Article 4 sec. 4 NP) is meant to cover the Multilateral System under the ITPGRFA. For all others, legal uncertainty persists. It should be clear, however, that states which host ex situ collections are responsible for making sure that rules governing accessions and the exchange of material are consistent with the ABS principles under Article 15 CBD. The bold proposition that collections are ‘not users’ and are therefore not subject to the NP, is certainly not substantiated. Considering the restorative intention of the discussed ex situ regimes, the following section examines if they ‘are supportive to and do not run counter to the objectives of the CBD’ (Article 4 sec. 2–4 NP), and conceptually reconsiders the function of collections as both ‘providers’ and ‘users’. Access The CBD’s goal is to make access to resources subject to the prior informed consent of provider states. The primary goal of the examined collections, however, is to restore prior exchange structures unhampered by exclusionary rights of states. Do collections thereby undermine the PIC requirement? What must be considered is that IPEN requires PIC clearance before it accepts material, ITPGRFA deems PIC clearance impossible for acknowledged reasons, 50 and DSMZ puts the duty on recipients. Thus the picture is not homogenous. It appears that the

Networks of ex situ collections of GR 257 practical effect of the collections’ regulations run counter to the CBD rationale. This is not to say that the regulations as such are not CBDcompliant. But the collections’ primary motive not to get involved in benefit sharing in any way undermines their intermediary, preparatory function to enable benefit sharing once commercial gains are realized. In order to substantiate this proposition, the collections’ motives have to be analysed. First, all three examined collections perceive themselves not to be primary addressees of the CBD. They interpret their own activities under the ABS rules to mean that they are incidental third parties. According to their perspective, it is ‘big business’ which owes benefit sharing to provider countries. They themselves can, and most are willing to, share the non-commercial benefits which they generate (scientific information). However, they need to respond to the rising pressure, to avoid accusations of ‘biopiracy’, and their own professional need to defend unhampered exchange against exclusionary practices of provider states and industry. Furthermore, in the case of IPEN, member gardens felt the need to respond regarding the denial of permits for bioprospecting, which threatens the quality of collections in the long term. Their primary motive was to secure in situ access to member gardens and to restore the trust of provider states, which had been lost because of growing suspicion as a result of ever increasing public–private collaboration and scandals. The functional core of the IPEN regulations serves to shield their exchange structures (which they perceive as part of non-commercial research) from the corporate world. Finally, the ITPGRFA response has several dimensions. The Multilateral System reacted to the (for their sector impractical) bilateral CBD scheme and to the patent enclosures which have restricted the free exchange of agricultural seeds since the 1990s. Various conflicts between FAO collections and the chemical industry over patent protection have disrupted the ideal of public collections as embedded service institutions committed to open exchange.51 The Multilateral System of the ITPGRFA is not only directed against the bilateral CBD approach, but also against the increasingly exclusionary structure of corporate agricultural business. Taking this background into account, the attempt to evade the CBD access rules reveals itself as an attempt to shield pre-market scientific research from pressures which first emerged between provider states and industry. As specialized regimes, their primary intention is not to circumvent CBD access rules, but to uphold the operative rules of the subsystem. Thus, the regulations are not preventing adherence to ABS rules in situ; however, they are also not supportive to provider states either. The central question, therefore, shifts to the effects of these regimes, and to the scope of responsibility of public collections to support the ABS rationale. When are sectoral agreements ‘supportive to and do not run counter to the objectives of the CBD’ (Article 4 NP)? From a legal standpoint, one may argue that the collections do not impede those who

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seek access in provider states and comply with provider states’ rules, and they are therefore compliant with Article 4 NP. Is this, however, enough to satisfy the requirement for ‘support’? Does the NP require a more proactive stance? Does it require collections to counsel industry on access regulations in provider countries? Do they owe active support to industry in order to acquire PIC for access and commercial use of material stored in their collections (serving users by reducing transaction costs, and serving the environment by avoiding in situ bio-prospection)? The quality of the duty will depend on the definition of what ‘support’ under Article 4 NP means. I argue, since the NP has shifted the focus of ABS from product marketing towards R&D by defining ‘utilization’ as ‘research and development’ (Article 2 lit. c NP). All institutions engaged in R&D, not only industry, bear a responsibility for ensuring that the ABS mechanism, as such, functions. In the face of global exchange structures, CBD duties cannot be confined in terms of territory in the sense that provider states have duties under Article 15 sec. 2 CBD (‘facilitation of access’), while user states bear duties under Article 15 sec. 7 CBD (‘benefit sharing’). I argue that provider and user states (including networks of ex situ collections and industry) have a shared responsibility for the CBD mechanism to function. Due to the negotiation process, these duties are reported as reciprocal duties of convention parties. However, the final legal text does not divide into duties confined to providers (‘access’), or user states (‘benefit sharing’). The mechanism was installed to achieve a joint goal, namely to bring the depletion of biodiversity to a halt. Therefore, each party bears a duty for the whole mechanism. Since ex situ collections serve, from a functional perspective, both provider and user functions, a simple assignment of access referring duties to provider states (no duties for user states) cannot be upheld. The ‘package of duties’ has to be inferred from a more comprehensive analysis which also takes the whole mechanism of ‘access and benefit sharing’ into account. Benefit sharing As much as collections aim to reinstall free access and exchange, they are interested in avoiding benefit sharing. This is the very background for the disputed classification of collections as ‘users’ or ‘providers’. They do not want to be classified as ‘users’ as they fear being obliged to share benefits in the sense that they are expected to pay.52 Nor do they want to be classified as ‘providers’ as they do not want to be held responsible by provider states for ensuring that PIC and MAT are to their benefit. Most collections describe themselves as ‘intermediaries’53 or ‘mediators’ (Gröger 2007: 123) between providers and users, between science (non-commercial use) and corporations (commercial use) (von den Driesch et al. 2008: 52).54 Some lean towards supporting the interests of provider states (IPEN);55 others perceive themselves primarily as service institutions for users (DSZM). Their

Networks of ex situ collections of GR 259 refusal to engage in benefit sharing is consistent with their position as noncommercial entities: they generate non-commercial benefits and only those can be shared. The most important benefit is the ‘coding’ (identification and individualization) of genetic resources. In addition, IPEN and biological collections stress that providers benefit from the conservation of material and their access to biological data.56 They initiate training of botanists (von den Driesch et al. 2008: 55), conservation and repatriation. IPEN aims at the bilateral inclusion of the provider institutions in the botanical gardens community.57 The ITPGRFA system conceives the share-alike mechanism as sharing. The point of departure is the self-description as ‘non-commercial’, generating non-commercial benefits, resulting in the duty to share noncommercial benefits. This line of argument, however, is the ‘user duty rationale’, which is not consistent with the intermediary rationale. This selfdescription makes all examined collections blind to the weaknesses in their regimes – namely, the fuzziness of today’s commercial and noncommercial research divide – which, in the long run, will undermine their credibility. The biggest weakness in the way IPEN operates is the exchange, under IPEN conditions, with universities (regardless of their contractual links to industry). In the ITPGRFA system it is the still missing funding (which undermines trust). The largest problem with microbial collections is accessions which are not cleared for ABS conformity. All three weaknesses impair the possibility that future benefits will be shared with provider states. These considerations shed light on what user states and collections owe under the NP. First, since the ABS mechanism cannot be split between the duties of provider and user states, user states bear a responsibility for regulating collections in the sense that they support, and not counteract, the access and benefit sharing mechanism (by deleting information). Second, collections owe benefit sharing once utilization results in benefits, whatever they may be. However, it is well understood that collections cannot be equated to ‘the’ (profit generating) ‘user’. Third, the collections’ most important activity is not covered by describing them as ‘users’. The identification of resources is clearly in the interests of both, users and providers. This double function is consistent with their own selfdescription as standing between providers and users, being ‘intermediaries’. As mediators, it is their task to provide transparency for partners to engage in informed negotiations. Decoupling and linking of access and benefit sharing Winter qualifies common pools as instruments which ‘decouple access and benefit sharing’:58 the duty to share benefits is decoupled from the provider state (and redefined as benefit to everybody, including provider state), and decoupled from the bilateral CBD rationale.

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The analysis of the three collection examples unearthed the functional element which enables decoupling of access and benefit sharing without discharging collections from ABS duties (thus upholding the connection). It is the intermediary function of ex situ collections. Economic theory defines intermediaries as ‘the creation of a separate market in between two other distinct markets’; in economic terms, their function is the reduction of transaction costs for other markets (Spulber 1999: xiv). Economists distinguish intermediaries embedded in the value chain (producing something new), and brokers in the supply chain (trading the same thing). This reflection is useful for distinguishing different collections in their function. If the focus is identification, typology, making the resource available to the broader public by publishing, storage, display, transfer, etc., a collection could be qualified as an ‘intermediary in the supply chain’. They typically do not transform resources, and generate no profits. But they still add value to the resource by the generation of information. Therefore, even if they generate non-commercial benefits, their duty is not reduced to share those. As long as the activity primarily serves ‘users’, intermediaries are submitted to a derived duty to assure benefit sharing. The image would be that they side with users (without being users themselves).59 In similar terms, the systems theory qualifies intermediaries as translators between autonomous rationalities (Willke 1992: 319). Their task is at the same time connection and keeping systems apart. This double duty, however, raises questions of incentives and funding. Modern literature on ‘trusted intermediaries’ (recently discussed in the context of drug discovery (Rai et al. 2009: 280) openly explores these questions and should be the subject of future research. Conclusion with regard to Article 4 NP compliance The analysis showed that collections under Article 4 NP have to do more than be passive regarding the ABS compliance of those from whom they get material and those to whom they deliver. However, this chapter will not stop short with an inversely legalistic conclusion that the current regulations of the examined ex situ collections do not comply with Article 4 NP, based on the argument that they do not actively support it. The ‘non-compliance’ conclusion would, under the current discussion, quickly be misunderstood as an argument for further commercialization of public research. The conclusion must be more careful for two reasons: first, it needs to protect public, non-commercial research, as it serves a central function to uphold the complexity of the private–public divide. Second, duties need to be differentiated according to the collections’ position along the abstract continuum between providers and users. However, I argue that ex situ collections fall short when either they resort to the old- fashioned saga of ‘non-commercial research’ or to the definition of being ‘non-users’. This simplistic reasoning accounts for the loss of trust in the public research of

Networks of ex situ collections of GR 261 provider states. The trust can only be re-established by an open discussion and with differentiated rules, which sensitively respond to the conflicts at the rim of public and private research. The consequence is that collections must be submitted to the control of national ABS authorities: information is secured not only in the interests of science, but also for NP compliance. Therefore, the generation and transmission of information has to be nondiscriminatory to countries of origin and not at the discretion of either the collection or the depositor. In the interest of global resource conservation, the avoidance of in situ bioprospecting can legitimately be organized by informing the provider state. National legislation may regulate the collections’ activities, install supportive international reporting structures, and may legitimately use the legal techniques of defining them as users or by clarifying that user rules are applied to them [mutatis mutandis].

Conclusion The analysis of three specialized pool regimes for ex situ networks reveals that they primarily restore prior exchange structures, and serve their own constituencies. However, they do not undermine the ABS rationale of the CBD, nor do actual arrangements actively support it. An important result of the analysis is the identification of wide loopholes due to regimes’ ideology as non-commercial. This carries the risk that the specialized instruments will in the long run lose the trust of provider states. A more nuanced reflection about legitimate interests of provider states relating to specialized instruments is needed. A conceptual result of a brief interdisciplinary, informed legal reflection is to conceptualize ex situ collections as intermediaries. The consequence is to submit them to ABS duties derived from users’ duty to share benefits, and to differentiate duties accordingly. Overall, the chapter concludes that these specialized regimes deserve support. However, they are in need of improvement. Regulation and institutional support should be installed to secure, at the same time, scientific quality and NP compliance. Speedy and functional diplomatic support needs to be provided for conflicts arising from access and benefit sharing. Financial support must be granted to intermediaries for providing support services to users. Under these conditions, the benefit-sharing mechanism as a whole (the general bilateral mechanism and specialized regimes) can be developed into a transnational redistributional instrument (a ‘tax’) earmarked for the preservation of biological diversity.

Notes 1 For an example of a provider state’s ex-situ collections, see the analysis in the TEFF case (Godt 2009: 71–90, 2012). 2 Whereas plant collections have been working on CBD compliance regimes for years, the broader public became aware of the transnational dimension of

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‘access and benefit sharing’ with regard to ex-situ collections in 2007 when Indonesia announced that it would deny access to its avian flu virus unless benefits (future developed vaccines) were shared (discussed at the WHO meeting on 25 November 2007); in the meantime a special regime on influenza viruses (the Pandemic Influenza Preparedness Framework administered by the WHO) has been negotiated (see Chapter 16). These two forms might be covered as argued by Winter and Kamau (2011), and Frein and Meier (2012: 13); an alternative view is presented by Buck and Hamilton (2011: 57) who reject the applicability of the CBD to pre-CBD material. Godt et al. (2012: 35) argue that whereas simple ongoing possession of preCBD material is not covered (due to ‘true retroactivity’), new forms of utilization are covered, requiring users to seek PIC and MAT from providers. Cf. Dedeurwaerdere (2010) who undertakes a similar exercise, focusing, however, on pressures to research commons by restrictive intellectual property rights instead of pressures of the ABS regime. DSMZ holds microorganisms, as well as human and animal cell lines, and serves as an International Depositary Authority (IDA) under the Budapest Treaty on the International Recognition of the Deposit of Microorganisms. Its collections contain over 15,000 cultures, representing some 6,900 species and 1,400 genera (archaea, bacteria, plasmids, phages, yeasts, fungi), http://www. dsmz.de, viewed 23 January 2013. E.g. Leibniz-Institut für Pflanzengenetik und Kulturpflanzenforschung (IPK) in Gatersleben (http://www.ipk-gatersleben.de/Internet, viewed 23 January 2013), adjacent to the national genbank for fruits (http://www.deutschegenbank-obst.de, viewed 23 January 2013); the UR Wageningen (Netherlands) holds both an animal genetic genbank (http://www.cgn.wur.nl/UK/ CGN+Animal+Genetic+Resources/Genebank, viewed 23 January 2013) and a plant genetic genbank (http://www.cgn.wur.nl/UK/CGN+Plant+Genetic+ Resources, viewed 23 January 2013). Be it for improving the scientific quality of the collection, or for financial reasons, e.g. the OECD ‘Scientific Collections International’ (http://scicoll. org, viewed 23 January 2013) initiative, a network of global national collections (like the British Museum, Museum für Naturkunde Berlin, Staatliche Museum für Naturkunde Stuttgart (the German collections constitute the DNFS.de)) currently headed by the Smithonian Instititution (Washington DC), (with some associated communal collections), which pool their collections digitally, provide connected information, repatriate knowledge, assist in building up collections in provider countries and engage in capacity building. See the prominent ‘Buffon Declaration’ of 19 October 2007, adopted by 93 natural history institutions at a symposium held at the Museum of Natural History in Paris, http://www.bfn.de/fileadmin/ABS/documents/ BuffonDeclarationFinal%5B1%5D.pdf, viewed 23 January 2013. For example, the Friedrich-Löffler-Institut für Tiergesundheit (with 11 subinstitutes of which one is hosted in isolation on the isle of Riem), http://www. fli.bund.de, viewed 23 January 2013. Not only do microbial collections digitalize their material (e.g. Uhlir 2011a: 86); also other large material collections (Botanical Garden Berlin, IPKGatersleben, Consortium of Natural Science History Museums) engage in building up digital databanks (Reinhold Leinfelder, until 2010 General Director of the Berlin Museum for Natural History, personal communication 23 June 2011). ‘Traceability’ vs ‘tracking’ was discussed by K Davis (2007) for the horticulture sector, advocating ‘ex-post-traceability’ as opposed to ‘ex-ante-tracking’

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(certificate). For a similar debate regarding microbiological resources, see Ph. Desmeth (2007) who advocates MASAICS as a system which allows both. Many microbiological collections work on a for-profit basis. Centre for Applications of Molecular Biology in International Agriculture (CAMBIA), having devised the Biological Open Source (BiOS) License. As a private non-profit research institute in Canberra, it launched the initiative in 2004, see http://www.cambia.org/daisy/cambia/home.html, viewed 28 January 2013, described by Berthels (2009). For a critical account on contractual commons with regard to the impact on the overall ‘freedom to operate’ in the agricultural sector, see Wright (2010: 363 et seq.). For an in-depth analysis of the multilateral system, see Chapter 17; also Henson-Apollonio (2009, pp. 289–293) or Gerstetter et al. (2007). http://www.planttreaty.org/sites/default/files/inclu_Germany.pdf, viewed 21 February 2012. A public foundation, http://www.ipk-gatersleben.de/ viewed 28 January 2013, and member of the Leibniz Society (an association), http://www.wgl. de/?nid=str&nidap=&print=0, viewed 23 January 2013. A federal government institution, http://www.jki.bund.de, viewed 23 January 2013. The Julius-Kühn-Institute is a higher federal agency, spread over 13 locations across Germany, http://www.jki.bund.de/de/startseite/ueber-das-jki.html, viewed 23 January 2013. The number indicates how many collections a signatory has included in the Multilateral System: Brazil (5), Canada (4), Czech Republic (14), Scandinavia (inclusion by species listed in the annex), Estonia (inclusion by species listed in the annex), Germany (17), Jordan (1), Syria (1), Lebanon (1), Netherlands (4), Namibia (1), Madagascar (10), Malawi (2), Portugal (inclusion by species listed in the annex), Romania (1), Spain (1), Sudan (1), Switzerland (included the national genebank and private ones), UK (inclusion by species listed in the annex), Zambia (1). Historically secured by (1) governments administering collections, and (2) an open access policy (see Kloppenburg (1988); Winter (1992)). As evidenced by No. 6.10 of the SMTA. On the fierce debate of the early days when negotiating the agreement (Godt 2007: 300 ff.). Status on 12 May 2011 (the number in brackets indicates the number of member’s gardens): Argentina (1), Austria (7), Belgium (3) Croatia (1), Czech Republic (1), Finland (3), France (6), Germany (47), Greece (3), Hungary (2), Israel (2) Italy (9), Luxemburg (1), Netherlands (21), Portugal (8), Romania (2), Spain (7), Sweden (3), Switzerland (14), United Kingdom (5). A rate higher than for botanical gardens in general (here 50 per cent), https:// www.cbd.int/doc/world/de/de-ex-bg-en.doc, viewed 23 January 2013. IPEN Code of Conduct of November 2003, http://www.botgart.uni-bonn.de/ ipen/conduct.pdf or http://www.bgci.org/resources/Description_of_IPEN, viewed 23 January 2013. Regarding the ‘checkpoints’ model, see von den Driesch et al. (2008: 55); on ‘unique identifiers’ and ‘sector specific regulation’, see Gröger (2007: 121). An example is ‘DE-0-BONN-02348’ (von den Driesch et al. 2008: 54): (1) DE encodes the provider state Germany, (2) ‘0’ stands for ‘unconditioned’, (3) the first accession garden was ‘BONN’, (4) and 02348 indicates that it was the 2,348th accession. Presumably, few commercial actors would pursue the costly ABS procedure for bio-prospection in the provider-state before being sure that their lead might produce financial returns.

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31 Annex 5 of the IPEN Code of Conduct. 32 Some collections chose to be deleted from the list, like the Botanic Gardens of Wageningen University (Arboretum). It was deleted from the IPEN list in October 2009 after deciding (for financial reasons) to discontinue its management of the two arboretums as scientific collections (personal information by Bert Visser, 1 September 2011). 33 Royal Kew Botanic Gardens and the US collections have a different tradition, which is historically oriented to serving the commercial sector (ten Kate 1999: 168 ff.). 34 Andreas Gröger for the Munich Botanic Garden, personal communication, 13 September 2011. 35 A uniform development worldwide: for Germany § 2 Abs. 7 Hochschulrahmengesetz (revised 12 April 2007); for the US: BayhDole Act (Godt 2007: 167); for developing countries: So et al. (2008). 36 Structurally, the turn towards a ‘knowledge and information society’ has rendered basic research immediately relevant for application. Financial restraints in the public sector pressure scientists to turn to third stream money (Godt 2007: 172 ff.). 37 http://www.wfcc.info/guidelines, viewed 23 January 2013. 38 http://www.wfcc.info/ccinfo/index.php/collection/col_by_country/a/49, viewed 21 February 2012. 39 Concentrating on (1) naturally occurring prokaryotes (bacteria and archaea), yeast, fungi and viruses/phages, (2) genetically manipulated organisms, but also animal and plant cell lines, all of which have been created by human intervention, and (3) the supply of antisera raised against viruses. 40 h t t p ://w w w. m f . n i e d e r s a c h s e n . d e/p o r t a l / l i v e . p h p ? n a v i g a t i o n _ id=986&article_id=1517&_psmand=5, viewed 21 February 2012. 41 http://www.wgl.de/?nid=ers&nidap=&print=0#anchor_C, viewed 21 February 2012. 42 The Budapest Treaty was signed in 1977 and is administered by the World Intellectual Property Organization. It allows deposits of microorganisms at an international depositary authority to be recognized as sufficient disclosure as a patentability requirement. 43 h t t p ://w w w. d s m z . d e/u p l o a d s/m e d i a / D S M Z _ A c c e s s i o n _ Fo r m _ Microorganisms_01.pdf, viewed 21 February 2012. 44 http://www.dsmz.de/deposit/deposit-in-the-open-collection.html, viewed 21 February 2012. 45 http://www.dsmz.de/bacterial-diversity/convention-on-biological-diversity. html, viewed 21 February 2012. 46 Ibid. 47 Ibid. 48 For example, for bacteria and fungi, http://www.dsmz.de/uploads/media/ bacfun_engl_01.pdf, viewed 21 February 2012. 49 M Kiehn, Director of the Vienna Botanical Garden, and Austrian IPEN appointee, interview, 19 September 2011. 50 And therefore, the preamble, recital 15, and Article 8c NP give multilateral ITPGRFA priority over the bilateral CBD approach. 51 For a discussion on ‘defensive patenting’ as a response by public collections to corporate patenting strategies, see Godt (2007: 300); with regard to the International Maize and Wheat Improvement Center (CIMMYT) example (the Mexican FAO collection on maize), see Feindt (2010: 22). 52 Similar to the scientific community, which has feared the CBD for blocking access. For the acceptance of giving and taking: R. Leinfelder, ‘Forschung für

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das Gedächtnis des Lebens’, Süddeutsche Zeitung, Sonderbeilage Artenvielfalt, 15 May 2008. For microbial collections: Dagmar Fritze, Managing Director of DSMZ, interview with F Wolff, 29 February 2012. Von den Driesch et al. (2008) speak about botanical gardens as ‘user and provider of plant material […] on the interface of non-commercial use and commercial use interests’. ‘We are advocates of the provider states’, A Gröger (IPEN appointee, Germany, Botanical Garden Munich–Nymphenburg), personal communication, 26 June 2012. R Leinfelder, personal communication, 23 June 2011: the current state of the art is a three- level dataset: basic data/meta data/sequences, each level is interconnected. See the example of the Katse Alpengarten Lesotho (von den Driesch et al. 2008: 55). See Chapter 14. A similar position is to be assigned to research funding organizations and academic scientists. Both groups ‘enable’ R&D on genetic resources similar to ex situ collections. Under the NP, academic researchers are classified as ‘users’. Collections are, in most cases, not ‘users’. However, the negative qualification does not exempt collections from ABS duties. All three groups may ‘side with’ users, in which case they have a ‘derived duty’ to ensure that benefit sharing is possible.

References Berthels, N (2009) ‘CAMBIA’s biological open source initiative (BiOS)’, in Van Overwalle, G (ed.), Gene patents and collaborative licensing models – patent pools, clearinghouses, open source models and liability regimes, Cambridge University Press, Cambridge, pp. 194–203. Buck, M and Hamilton, C (2011) ‘The Nagoya Protocol on access to genetic resources and the fair and equitable sharing of benefits arising from their utilization to the Convention on Biological Diversity’, Review of European Community & International Environmental Law (RECIEL), 20 (1), pp. 47–61. Burk, D (2009) ‘Critical analysis: property rules, liability rules and molecular frictions – bargaining in the shadow of the cathedral’, in Van Overwalle, G (ed.), Gene patents and collaborative licensing models – patent pools, clearinghouses, open source models and liability regimes, Cambridge University Press, Cambridge, pp. 294–307. David, PA (2011) ‘Breaking anti-commons constraints on global scientific research: some new moves in ‘legal jujitsu’’, in Uhlir, PF (ed.), Designing the microbial research commons: proceedings of an international symposium, National Academies Press, Washington DC, pp. 13–24. Davis, K (2007) ‘Certificating biodiversity: practical issues for ex situ collections’, in Feit, U and Wolff, F (eds), European regional meeting on an internationally recognized certificate of origin/source/legal provenance, Bundesamt für Naturschutz, Bonn, pp. 133–135. Dedeurwaerdere, T (2010) ‘Institutionalizing global genetic resource commons: towards alternative models for facilitating access in the global biodiversity regime’, Working paper, 12 June 2010, http://papers.ssrn.com/sol3/papers. cfm?abstract_id=1611549, viewed 23 January 2013.

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Desmeth, P (2007) ‘ABS in case of microbial resources – MOSAIC’s Integrated Conveyance System’, in Feit, U and Wolff, F (eds), European regional meeting on an internationally recognized certificate of origin/source/legal provenance, Bundesamt für Naturschutz, Bonn, pp. 124–132. Feindt, PH (2010) ‘Biopatente – eine Gefährdung für Nutzung und Erhaltung der Agrobiodiversität? [Expert opinion of the Council for Biodiversity of the Federal German Ministry for Food, Agriculture and Consumer Protection], BMELV, Bonn. Feit, U and Wolff, F (eds) (2007) European regional meeting on the internationally recognized certificate of origin/source/legal provenance, Bundesamt für Naturschutz, Bonn. Frein, M and Meyer, H (2012) Wer kriegt was? Das Nagoya-Protokoll gegen Biopiraterie. Eine politische Analyse, Evangelischer Entwicklungsdienst e.V. (EED), Bonn. Gerstetter, C, Görlach, B, Neumann, K and Schaffrin, D (2007) ‘The International Treaty on Plant Genetic Resources for Food and Agriculture within the current legal regime complex on plant genetic resources’, Journal of World Intellectual Property, 10 (3–4), 259–283. Godt, C (2007) Eigentum an Information, Mohr Siebeck, Tübingen. Godt, C (2009) ‘Regulatory paradoxes – the case of agricultural innovation’, in Drexl, J, Godt, C, Hilty, R, Remiche, B and Boy, L (eds), Technology and Competition – Technologie et Concurrence, Larcier (De Boek), Brussels, pp. 71–90. Godt, C (2012) ‘Zugang und Vorteilsausgleich gemäß der Konvention für biologische Vielfalt – Lehren aus dem TEFF-Fall’, in Bette, K and Stephan, M (eds), Biodiversität, geistiges Eigentum und Innovation, BMELV, Bonn, pp. 189–210. Godt, C, Šušnjar, D and Wolff, F (2012) ‘Umsetzung des Nagoya-Protokolls ins Deutsche Recht (Teilstudie I)’, Unpublished expert opinion commissioned by the Federal Ministry of Environment (submission 9 March 2012). Gröger, A (2007) ‘Botanic gardens and the IPEN – a brief statement on an internationally recognized certificate’, in Feit, U and Wolff, F (eds), European regional meeting on an internationally recognized certificate of origin/source/legal provenance, Bundesamt für Naturschutz, Bonn, pp. 121–123. Henson-Apollonio, V (2009) ‘The International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA)’, in Van Overwalle, G (ed.), Gene patents and collaborative licensing models – patent pools, clearinghouses, open source models and liability regimes, Cambridge University Press, Cambridge, pp. 289–293. Kamau, EC and Winter, G (eds) (2009) Genetic resources, traditional knowledge and the law: solutions for access and benefit sharing, Earthscan, London. Kilian, A (2009) ‘Case 9. Biodiversity Arrays Technology Pty Ltd. Applying the open source philosophy in agriculture’, in Van Overwalle, G (ed.), Gene patents and collaborative licensing models – patent pools, clearinghouses, open source models and liability regimes, Cambridge University Press, Cambridge, pp. 204–212. Kloppenburg, JR (1988) First the seed, Cambridge University Press, Cambridge. Rai, AK, Reichman, JH, Uhlir, PF and Crossman, C (2009) ‘Pathways across the valley of death – novel intellectual property strategies for accelerated drug discovery’, in Van Overwalle, G (ed.), Gene patents and collaborative licensing models – patent pools, clearinghouses, open source models and liability regimes, Cambridge University Press, Cambridge, pp. 247–288. Reichman, J and Uhlir, PF (2003) ‘A contractually constructed research commons for scientific data in a highly protectionist intellectual property environment’, Law and Contempory Problems, 66 (1 and 2), pp. 315–440.

Networks of ex situ collections of GR 267 Schloen, M, Louafi, S and Dedeurwaerdere, T (2011) ‘Access and benefit-sharing for genetic resources for food and agriculture – current use and exchange practices, communalities, differences, and user community needs’, FAOBackground Study Paper No. 59, Commission on Genetic Resources for Food and Agriculture, Rome, http://www.fao.org/docrep/meeting/023/mb720e. pdf, viewed 23 January 2013. So, AD, Sampat, BN, Rai, AK, Cook-Deegan, R, Reichman, JH, Weissman, R and Kapczynski, A (2008) ‘Is Bayh-Dole good for developing countries? Lessons from the US experience’, PLoS Biol, 6 (10), e262, http://www.plosbiology.org/ article/info:doi/10.1371/journal.pbio.0060262, viewed 23 January 2013. Spulber, DF (1999) Market microstructure – intermediaries and the theory of the firm, Cambridge University Press, Cambridge. ten Kate, K (1999) ‘Horticulture’, in ten Kate, K and Laird, SA (eds), The commercial use of biodiversity, Earthscan, London, pp. 158–187. Uhlir, PF (ed.) (2011) Designing the microbial research commons, National Academies Press, Washington DC. Uhlir, PF (2011a) ‘Designing the digital commons in microbiology – moving from restrictive dissemination of publicly funded knowledge to open knowledge environments: a case study in microbiology’, in Uhlir, PF (ed.), Designing the microbial research commons, National Academies Press, Washington DC, pp. 77–90. Van Overwalle, G (ed.) (2009) Gene patents and collaborative licensing models – patent pools, clearinghouses, open source models and liability regimes, Cambridge University Press, Cambridge. Van Overwalle, G (2011) ‘Individualism, collectivism and openness in patent law – from exclusion to inclusion through licensing’, in Rósen, J (ed.), Individualism and collectiveness in intellectual property, Ed. Elgar, Cheltenham, pp. 71–114. von den Driesch, M, Lobin, W and Gröger, A (2008) ‘Das internationale Pflanzenaustausch-Netzwerk botanischer Gärten: ein Modell im Umgang mit ABS?’, Natur und Landschaft, 83 (2), pp. 52–56. Willke, H (1992) ‘Ironie des Staates – Grundlinien einer Staatstheorie polyzentrischer Gesellschaft’, Suhrkamp, Frankfurt am Main. Winter, G (1992) ‘Patent law policy in biotechnology’, Journal of Environmental Law, 4 (2), 167–187. Winter, G and Kamau, EC (2011) ‘Von Biopiraterie zu Austausch und Kooperation: das Protokoll von Nagoya über Zugang zu genetischen Ressourcen und gerechtem Vorteilsausgleich’, Archiv des Völkerrechts, 49 (4), 373–398. Wright, BD (2010) ‘Agricultural biotechnology: the quest to restore freedom to operate in the public interest’, in Dreyfuss, RC, First, H and Zimmerman, DL (eds), Working within the boundaries of intellectual property, Oxford University Press, New York, pp. 359–367.

13 Biological databases for marine organisms What they contain and how they can be used in ABS contexts1 Gorch Detlef Bevis Fedder Introduction Although biological databases were not developed with ABS in mind, they have great potential to improve horizontal equity in benefit sharing, i.e. benefit sharing between all source states sharing the same genetic resource (see Chapter 1). International agreements, such as Article 11 of the Nagoya Protocol prescribing transboundary cooperation and regional agreements, such as Andean Community Decision 391, already aim at improving horizontal equity by establishing a central mechanism to distribute benefits to member states. However, such agreements cannot achieve total fairness in benefit sharing as long as the true countries of origin are not scientifically identified. In such cases, benefits may be shared by either too many countries if the genetic resource is, for example, endemic to one state or by too few countries if the resource has a transregional or even global distribution. Moreover, the downstream approach commonly applied in monitoring the use of genetic resources – tracing from source states to products derived from the GR – has often been criticized for its ineffectiveness. Likewise, the upstream approach – tracing from user states back to states of origin – poses problems because products cannot be easily traced back to source countries. However, biological databases could circumvent the deficiencies of these two approaches by providing the scientific basis to follow the chain of valorization back to the geographical origin of the resource. No single database fulfils this task completely, so different databases with different services need to be combined in two consecutive steps. In the first step, databases with information on biological molecules need to be consulted for the source species name. In the second step, databases with information on the geographical distribution of species need to be queried to identify which states are involved in the source species’ distribution. As well as contributing to horizontal equity, biological databases can provide beneficial effects. First, they could constitute the important infrastructure of the global multilateral benefit-sharing mechanism as envisaged by Article 10 of the Nagoya Protocol. Second,

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they contribute to effective monitoring by providing instruments that illuminate the R&D process. Such instruments include references to the relevant scientific literature, patents, market products and companies selling such products. Third, they promote public R&D by making data available to the global scientific community. Last, they contribute to benefit sharing by making the benefits envisaged by the Nagoya Protocol available to ABS stakeholders. The original purpose of biological databases was to manage the tremendous amount of data generated by biological research (Apweiler et al. 2003: 343). The collected data cover a wide range of biological information and include information on biological molecules, taxonomy and geographic distribution of organisms (biogeography) (Benoît and College 2006: 180). Scientists use biological databases to access, visualize, analyse and interpret this data. In particular, scientists can: compare molecular structures and discover meaningful patterns; obtain background information on biotechnological applications as well as chemical, physical and biological properties; identify biological relationships between species; and locate occurrences of species and access the relevant scientific literature (Goodman 2002: 68, Köhler 2004: 61). To date, there are more than 1,300 databases on biological molecules, and approximately 100 new databases emerge annually (Galperin and Cochrane 2011: D1). Most of these are highly specialized and focus on specific organisms, disease pathways, protein families or domains, biomolecular tools or sophisticated services. Despite this complexity, it would improve fairness in benefit sharing if databases on biological molecules mentioned the source species and if biogeographic databases unequivocally identified the geographic occurrence of the source species. The spectrum of products that could be traced back to the source state is potentially broad. Most products derived from the utilization of genetic resources involve biological molecules, e.g. as the active ingredient in medicines or the genetic trigger of traits in modified organisms (CBD GTLE 2008: 11–12). Such molecules involve nucleic acids, proteins, carbohydrates, fatty acids, lipids and many other biochemical compounds. Although there are databases that cover each of these types of molecule, tracing the source is not always a straightforward task. The main challenge is to find the right keyword with which to query the databases. For prominent products, such as a blockbuster drug, finding the right keyword is a simple task: it might only need the brand name taken from a product advertisement in a newspaper or on television. However, most biological molecules examined for bioactivity never result in a marketable product (CBD GTLE 2008: 14). As a result, they might never receive a common name or a catchy product title but have only their scientific name, which is often a complex term describing the molecule’s structure (International Union of Pure and Applied Chemistry (IUPAC) name). Such situations require in-depth investigations into the scientific names of the biological

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molecule and its synonyms in scientific literature in order to obtain reference points with which to query databases. This chapter will give the example of using selected biological databases in order to identify source states and to monitor the R&D process of a selected product, the AquAdvantage® salmon.

‘opAFP-GHc2’ and the AquAdvantage® salmon The increasing demand for seafood and economic inefficiencies of traditional breeding have led to the integration of modern biotechnologies into marine aquaculture (Morse 1986: 348–353). Transgenic fish is one example. A transgenic fish is a genetically modified fish that carries a transgene – a genetic construct extracted from a source organism and integrated stably into the genome of the target organism. Such modified fish can be more resistant to low temperatures and pathogens, and have improved growth performance (Chiou et al. 2007: 833–850). Concerning improved growth, the AquAdvantage® salmon is about to receive official approval for human consumption in the United States (AquaBounty 2011). The genome of this modified salmon carries copies of the transgene ‘opAFP-GHc2’, which comprises antifreeze promoter and terminator regions from Atlantic Ocean pout, Zoarces americanus, and a growth hormone gene from Pacific Chinook salmon, Oncorhynchus americanus (Yaskowiak et al. 2006). The result is a salmon organism that has a 25 per cent better food-conversion rate and reaches market size within 1.5 years instead of 3 years. The reason for the improved growth performance is that modified salmon feed all year round instead of only in spring and summer, as unmodified salmon do.

Selected biological databases There are many databases that allow products to be traced and the use of different kinds of biological molecules to be monitored. For the AquAdvantage® salmon, only three databases will be used: GenBank, PubMed and the biogeographical database of the Global Biodiversity Information Facility (GBIF). GenBank 2 GenBank is a comprehensive, freely available, regularly updated online database that contains the annotated records of DNA sequences for more than 300,000 organisms (Benson et al. 2010: D46–47). Each record contains: the name of the genetic construct; an accession number; the scientific name of the source organism(s); bibliographical references; the complete genetic sequence; and a description of functional regions within the sequence. Users of the database can access records quickly and easily

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via a keyword search. Keywords can be any term found within a record, such as the name of the genetic construct or the accession number. GenBank falls under the aegis of the National Center for Biotechnology Information (NCBI), which ultimately falls under the United States Department of Health and Human Services (Wang et al. 2009: W623). In order to contribute data, data holders must be registered and use specific software. With regard to retrieving data, any person may freely access the database, and distribute and copy data, with the only condition being proper acknowledgement. For monitoring utilization, GenBank cites the relevant publication of the authors who have submitted data into GenBank. In addition, GenBank provides cross-links to the literature databases PubMed and PubMed Central. PubMed3 PubMed is the major literature database of NCBI. It comprises 20 million citations from life science journals and online books. It mainly covers biomedical literature from medicine, nursing, the health care system and preclinical science. It also contains some literature from non-medical fields. While PubMed does not include full text journals, it provides abstracts and links to subscription-based or free online sources of scientific papers. Abstracts may be a sound option for effective monitoring, because they give the information necessary to identify the use of a particular compound and thus to verify the legitimacy of the use according to mutually agreed terms. Closely related to PubMed is the free full-text archive of scientific journals at NCBI, PubMed Central, which contains 2.3 million articles (NCBI 2011). Global Biodiversity Information Facility4 GBIF is an international government-initiated and -funded organization focusing on publicly disclosing global biodiversity data through their web portal. The data is summarized in species overview pages. Each overview page provides details of the taxonomic lineage of the species and several services that allow the user of the database to explore records on species occurrences. These services include listing countries with occurrences, downloading geo-referenced occurrences in GIS-formats and displaying occurrences on a global map. Each occurrence is accompanied by a variety of metadata stating details on the taxonomy of the species, geospatial circumstances of the occurrence (e.g. depth and coordinates) and the data publisher. In order to publish data, data owners need to register and agree to the GBIF Data Sharing Agreement. Under the Agreement, data publishers agree that they disclose their data publicly, assert no intellectual property rights and have made the necessary agreements with the original owners of data (e.g. the country of origin). Data users must agree to the

272 Gorch Detlef Bevis Fedder GBIF Data Use Agreement under which they acknowledge that the quality and completeness of data cannot be guaranteed, agree to respect restrictions to sensitive data and mention the data publishers. Once database users accept this Agreement, they can query the database by using keywords on species, countries or datasets (GBIF 2007; Lane and Edwards 2007: 1–4).

Applying databases to the AquAdvantage® salmon This section illustrates how the databases introduced above can be used to trace the product back to source countries. Backtracing The source countries of the genetic construct ‘opAFP-GHc2’ were retrieved in two consecutive steps. In the first step, GenBank was used to link the product with the source species. The product ‘opAFP-GHc2’ was used as a keyword search in GenBank, which provided the relevant entry on the genetic construct. The entry was browsed for references to the biological source: Zoarces americanus (ocean pout) and Oncorhynchus tshawytscha (Chinook salmon) (Figure 13.1). In the second step, the GBIF geographical database was used to link the source species to their source states. To do this, their Latin names were used as keyword searches in GBIF. As a result, GBIF produced global distribution maps of these species (Figure 13.2). In order to obtain a more complete list of source countries, GBIF was also used to produce lists of countries (Table 13.1). These lists not only include source countries with geographic coordinates (already included in the global map) but also those without coordinates. The GenBank entry shows a wide range of information on the genetic construct, which should not confuse the database user. The top of the entry covers general information including: a unique accession number (AY687640); the length of the sequence (4061 base pairs); the type of the construct (linear DNA); the submission date; the title of the entry; keywords; and the source organism. As source organism, the entry mentions only the ‘synthetic construct’, because the genetic sequence has been artificially assembled from organisms of different species. As a result, indications of the source species must be looked for elsewhere in the entry. Below the general information are references, which list the relevant publications that reproduce the genetic sequence in printed form. Below these references, the entry lists features of the sequence. These highlight special areas of the construct and their exact location in the basepair sequence. The first four sub-items of the features section (marked ‘source’) are especially relevant for backtracing. They indicate what part of the genetic sequence originally belongs to a particular species. For example, the first 2197 basepairs derive from ocean pout, while the next ~700

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Figure 13.1 Partial screenshot of the GenBank entry on the genetic construct ‘opAFP-GHc2’ indicating the source species (solid frames) and information relevant to monitoring utilization (dashed frames). Although this entry contains multiple indications of the source species, it only refers to two species: (Macro-) zoarces americanus (ocean pout) and Oncorhynchus tshawytscha (Chinook salmon). Note that Salmo salar (Atlantic salmon) is not mentioned because it provides only the target genome into which the genetic construct is integrated (source: Hew and Fletcher 2001 and Agarwal-Mawal et al. 2004)

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Figure 13.2 Distribution maps of species from which the genetic sequences for ‘opAFP-GHc2’ were obtained: Zoarces americanus (ocean pout) and Oncorhynchus tshawytscha (Chinook salmon). For completeness, the distribution map of the organism providing the target genome, Salmo salar (Atlantic salmon) is also included (sources: Biodiversity occurrence data accessed through GBIF Data Portal, http://data.gbif.org, viewed 9 November 2011. The underlying data of the maps come from multiple data providers5)

basepairs come from Chinook salmon, and the last 1,200 basepairs derive from ocean pout again. Below this, the entry shows specific areas according to their function. For example, ‘promoter’ denotes the part of the sequence

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triggering expression of the gene, ‘CDS’ (coding sequences) is the part that encodes for expression of growth hormone proteins that make AquAdvantage® salmon grow faster, and ‘terminator’ marks the end of the sequence. Due to limited space, Figure 13.1 does not show the rest of the entry, which presents the complete sequence in single-letter basecode (A, T, G, C). The distribution maps reproduced in Figure 13.2 illustrate the global distribution of the two source species of the genetic construct (ocean pout and Chinook salmon) as well as the species providing the target genome (Atlantic salmon). Strikingly, these maps show that the distributions of these species are not confined to distinct regions. Instead, these species occur over vast areas spanning millions of square kilometres and many countries. Taking Chinook salmon as an example (middle map), this species occurs throughout the northern Pacific and even has occurrences as far away as Australia and New Zealand.6 Although the Chinook salmon arguably constitutes an extreme example, large distribution ranges of marine species are common due to the special physical characteristics of seawater (Carr et al. 2003: S92–93). This will pose a challenge for regional agreements which aim at sharing benefits between member states only, because the range of countries of origin (and thus of potential beneficiaries) is often much larger than the geographical scope of regional agreements. It should be noted that many records of Chinook salmon and Atlantic salmon occur on land. This is not an error; many salmon species are anadromous and ascend headwaters of river systems to spawn. Table 13.1 List of source states for AquAdvantage® salmon (source species of ‘opAFP-GHc2’ and Salmo salar) Product

Species

Source countries

AquAdvantage® salmon

Zoarces americanus Oncorhynchus tshawytscha Salmo salar

Argentina, Australia, Canada, China, Chinese Taipei (Taiwan), Denmark, Finland, France, Germany, Greenland, Iceland, Ireland, Isle of Man, Italy, Luxembourg, Japan, Namibia, Netherlands, New Zealand, Norway, Poland, Portugal, Russian Federation, Saint Lucia, Senegal, Spain, Sweden, Tajikistan, Ukraine, United Kingdom, United States, Uzbekistan

Note: This table gives countries without map occurrences Source: Biodiversity occurrence data accessed through GBIF Data Portal, http:// data.gbif.org, viewed 9 November 2011. The underlying data of the maps come from multiple data providers (see note 6)

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Monitoring For monitoring utilization, GenBank and PubMed were used to find relevant information. The GenBank entry provided useful indications on commercial aspects, including a reference to the European patent (EP 0578653) and the company planning to market the transgenic salmon, AquaBounty (Figure 13.1 and Table 13.2). PubMed also contained the reference to the scientific publication analyzing ‘opAFP-GHc2’ in detail (Yaskowiak et al. 2006). Table 13.2 Non-exhaustive list of research papers, patents and firms relevant to the research and development of the genetic construct ‘opAFP-GHc2’ Product

Paper

Patent

Company

opAFP-GHc2

Yaskowiak et al. 2006

EP 0578653

AquaBounty

Sources: GenBank entry and paper mentioned within PubMed. Note that papers and patents may contain further references

Conclusions Biological databases contribute greatly to horizontal equity in benefit sharing. They are also useful as the main scientific instruments implementing the global multilateral benefit-sharing mechanism, and they promote effective monitoring, public R&D and the objectives of the CBD. However, their usefulness for ABS is limited by a number of weaknesses. Horizontal equity in benefit sharing Biological databases are sound scientific tools that allow the tracing of products derived from the utilization of genetic resources back to (all) the resources’ countries of origin. According to Article 2.4 of the CBD, countries of origin are countries that possess genetic resources in in situ conditions. Databases can thus complement existing regional agreements, which aim to provide equitable distribution of benefits between countries of origin but which lack adequate means to unequivocally identify these states. Examples are Decision 391 of the Andean Community, the draft Association of South-East Asian Nations (ASEAN) Framework Agreement on Access to Biological and Genetic Resources or the Framework Agreement of the Hindu Kush-Himalayan Region. Although the approach of regional agreements to horizontal equity is laudable, the shortcoming of these agreements is that they share benefits with only those countries that are covered by the regional agreement. However, many species, and

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particularly marine species, are not confined by regional boundaries but have transregional or even global distribution. This fact supports the proposal that benefits should be shared multilaterally with all countries of origin. Global multilateral benefit-sharing mechanism The Nagoya Protocol supports multilateral benefit sharing. Article 10 proposes a ‘global multilateral benefit-sharing mechanism’ for genetic resources that occur in ‘transboundary situations’. Although the Protocol does not explain how such a mechanism might function, it paves the way for the international community to create an agreement on a global benefit-sharing mechanism.7 According to Article 4.2 of the Protocol, parties can develop and implement other relevant international agreements, including specialized access and benefit-sharing agreements. Biological databases could then be the central scientific tools of the benefit-sharing mechanism to identify (all) countries of origin or, in other words, the beneficiaries of utilization. Although the exact form of such a mechanism is far from clear, inspiration can be taken from existing global mechanisms, for example, the Global Environment Facility (GEF), which is the financial mechanism of the CBD. It receives financial contributions and allocates these to eligible states worldwide to support projects aimed at conservation of biological diversity and sustainable use of its components. The amount of money available to each state is calculated by a set of scientific indicators, such as the distribution of species. It is possible that the mandate of the GEF could be extended to distribute monetary benefits derived from utilization of genetic resources in transboundary situations by using species distributions from biological databases. If a particular use of a genetic resource generates benefits, the GEF Secretariat could identify the countries of origin by using biological databases. The full share of monetary benefits would then be divided by the number of countries of origin, and each country would receive a share of benefits on top of any previously allocated funds. Although member states of the Nagoya Protocol could establish a new institutional framework for the multilateral benefit-sharing mechanism, the advantages of using the GEF-framework would be that: a) horizontal equity in global benefit sharing is in the hands of an institution already experienced in using scientific means to allocate financial resources; b) the GEF pursues the objectives of the CBD; and c) the duplication of mechanisms with similar scope is avoided. Effective monitoring Biological databases contribute greatly to effective monitoring by referring to relevant research papers, patents, brands and companies. Research

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papers are one of the main tools for monitoring, because they help to illuminate the largest part of the intricate ‘web of valorization’, in which genetic resources change hands frequently, are modified and result in products with little similarity to the original resource accessed (CBD GTLE 2008: 10–14, Biber-Klemm et al. 2010: 16). While research papers allow the monitoring of the non-commercial phase of valorization, references to patents, brands and companies are powerful tools to monitor the marketing phase of products. These tools allow stakeholders to identify users with commercial intentions and to request that such users share commercial benefits. A novel and related approach to monitoring could be applying persistent identifiers – unique identification codes that accompany genetic resources downstream (Garrity et al. 2009: 53–86). As soon as a user collects and intends to use a genetic resource, the resource would receive an identifier that is stored at a central repository. Any transfer, new use or feeding into databases would be recorded by the repository. For monitoring, provider states could use such identifiers to consult the repository (e.g. online), which then provides the locations and uses of the resource. ABS-relevant documents, such as certificates of compliance and patents, could also be linked to the identifier. To make such a system work, specific identifiers must be used universally by all stakeholders, and users need to inform the repository about transfers and new uses. A similar system is already applied by GenBank, which employs ‘accession numbers’ for DNA sequences. Public R&D Biological databases promote public R&D in three ways. First, they have various advantages over scientific journals, which facilitate the exchange and use of data between scientific peers. Biological databases a) have much more space; b) concentrate research results from many different researchers and make them available in an aligned and concise way; c) publish data and results much more quickly; d) allow the downloading of data for further use; and e) provide tools and software for data comparison and manipulation. Thus, databases provide the means that can speed up the R&D process. Second, provider states do not need to adopt overly stringent ABS legislation to assure legitimate utilization of genetic resources. One of the major concerns that prompts source states to confine R&D is losing control over the fate of their genetic resources once they are exported. Biological databases improve this situation by allowing provider states to monitor (e.g. by using persistent identifiers) and therefore retain control over the use of genetic resources. Provider states may therefore choose to adopt simplified access legislation and impose fewer monitoring obligations on users. This in turn would attract more scientific research. Third, if there were an agreement to share benefits with countries of

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origin identified by databases, states would be encouraged to increase their taxonomic and biogeographic research efforts in order to qualify for benefit sharing. Objectives of the CBD The main contribution of biological databases to the objectives of the CBD is pathways to a more equitable distribution of monetary benefits among states, which better meets the needs of regional and global biodiversity conservation (see above). In addition, providers and users of genetic resources can agree to use databases to share some of the central non-monetary benefits as laid down by the Nagoya Protocol. These benefits include: •

•

• •

Sharing of research and development results (Annex, point 2(a) Nagoya Protocol): Researchers make their results and contact details freely available through deposition of data or publications. Source states can then contact researchers directly to request additional data. Contributions to scientific research (Annex, point 2(b)): Researchers in source states can use data from databases to conduct their own research. Contributions to education and training (Annex, point 2(d)): Many databases provide educational and supporting material on how to use their data. Access to scientific information relevant to conservation and sustainable use of biological diversity (Annex, point 2(k)): Biographic databases often offer taxonomic services that help to assess threatened species and manage biodiversity in source states.

Weaknesses The greatest strength of biological databases in helping to identify countries of origin is also one of their major weaknesses. According to Articles 5.1 and 6.1 of the Nagoya Protocol, the country able to determine access and stipulate benefit sharing is the country providing the genetic resources. Article 2.5 of the CBD defines this country as ‘the country supplying genetic resources collected from in-situ conditions…or taken from ex-situ sources, which may or may not have originated in that country’. However, these countries are not identified by biological databases, so they do not improve vertical equity in benefit sharing. States that uphold the bilateral exchange of genetic resources and benefits may therefore reject biological databases instruments as a means of improving horizontal equity in benefit sharing, because they would forfeit the full share of benefits. In response, one needs to consider the objectives of the CBD: conservation and sustainable use in a global sense. Benefits that accrue globally or even regionally fulfil this criterion much better than benefits that flow unilaterally to the provider state.

280 Gorch Detlef Bevis Fedder Another problem is incomplete databases. No single database can capture the full variety of biological information that exists in the world. Much of the knowledge on biological molecules is fragmented in smaller, isolated databases; there may be many more papers, patents, brands and companies not captured by databases; and much taxonomic and biogeographic data remains undisclosed in museums, aquaria and herbaria. In addition, sampling efforts are usually limited, scattered and not standardized, and inventories focus on easily accessible sampling sites and organisms (Hortal et al. 2007: 853f). As a result, biodiversity data are still scarce, biased and sometimes of poor quality. Taking the distribution of marine species as an example, coastal areas are better explored than the deep sea, the oceans of the northern hemisphere are better sampled than those in the southern hemisphere, and the distribution of marine vertebrates is more reliably represented than that of invertebrates, with microbial species being the least documented (Vanden Berghe 2007). A more critical problem is outdated records. In such cases, a state that has failed to maintain the survival of a species could still be rewarded as a country of origin, if the record has not been updated. No single database provides all the services that allow the tracing of products back to the source and the monitoring of R&D. Consequently, users interested in these services need to combine several databases to obtain all desired results. This is problematic, because many databases have a subscription fee, which is often too high for providers of genetic resources in developing states to afford. This in turn undermines the objectives of the CBD, because providers forfeit access to the benefits, which are generated by databases for the scientific community. To remedy this situation, database operators could support developing states to access their database by offering reduced fees or free licences. The search interfaces of many databases require technical background knowledge in order to produce successful queries. Concerning biological molecules, this does not only include knowledge of common names and synonyms, but also of more technical criteria, such as molecular structures, chemical nomenclature, or physical, chemical and biological properties. A system of persistent identifiers might ameliorate this deficiency once employed. Finally, it is unclear how users of genetic resources will react to databases being used as ‘ABS agents’. The research community might perceive it as an unsolicited intrusion into their domain and, consequently, reduce the feeding of data into databases, which would then impede R&D. However, scientists should regard databases as a new tool to facilitate their research. If scientists and providers can agree on databases to monitor the R&D process, providers may adopt less stringent access conditions that would otherwise ensure monitoring. Through databases, providers could control the legitimacy of utilization and users could provide central nonmonetary benefits, while the R&D process remains largely unaffected.

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However, the incentive for commercial users to feed data into databases is less obvious. On the one hand, commercial users often rely on scientists with non-commercial aims to obtain samples, so they are not directly involved in complying with access conditions. On the other hand, such users often conceal R&D until a marketable product or a patent is within reach. For such cases, states may choose to adopt hard law obliging commercial users to feed their data into databases.

Recommendations In order to increase the usefulness of biological databases for ABS, the following steps are recommended. First, parties to the Nagoya Protocol should, when considering the need for and modalities of a global multilateral benefit-sharing mechanism, discuss and acknowledge the important contribution biological databases can make when implementing such a mechanism. Databases could be the central scientific tools of this mechanism, unequivocally identifying the countries of origin which would benefit from the commercialization of products derived from their genetic resources. In addition, using databases is simple and cost-effective, because the suite of commercial products is manageable. A small administrative body, or a branch of the CBD Secretariat, could easily manage backtracing and channel funds to countries of origin. Alternatively, the GEF, being the institution most experienced at distributing funds by using scientific data, might consider expanding its mandate to incorporate the global benefit-sharing mechanism. Meetings of the CBD or the Scientific and Technical Advisory Panel of the GEF would be ideal forums to discuss and prepare this issue for upcoming meetings of, for example, the Intergovernmental Committee for the Nagoya Protocol or the GEF Assembly and Council. Second, regional ABS agreements should now start to use databases to allocate benefits from their common fund among (member) countries of origin. The successful application of this method in regional systems would illustrate the viability of using databases for ABS and promote their value for global benefit-sharing mechanisms. Third, a provider state should see itself less as a receiver of benefits and more as a contributor to global biodiversity conservation. It should therefore waive requesting full shares of any future benefits – a situation unlikely to occur in any case, given the minute fraction of samples that are actually developed into commercially viable products. Instead, it should support the collection of monetary benefits by global mechanisms, which use biological databases to identify countries of origin. This approach could also benefit the provider state in the long run, because other states could follow its example and also agree that benefits flow into the mechanism. This would increase the overall funds available to the mechanism, and in turn increase the funds that eventually flow back to

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the provider state (if it qualifies as country of origin). In summary, a global mechanism might ensure a more reliable flow of benefits rather than waiting in the vain hope of being the provider state for the source of a blockbuster product. Fourth, a large responsibility also falls to the database providers themselves. Larger databases should integrate smaller, isolated databases into their data network, thereby extending their data coverage. They should offer more services that facilitate backtracing and the monitoring of utilization by including, for example, references to commercial products derived from utilization and their manufacturers. Databases should become more user-friendly and, where relevant, cheaper, in order to be more accessible for ABS stakeholders. It is imperative that databases at least mention the source species and, if possible, the country that provided the material. Similarly, they should oblige users to mention the biological and the geographical source of the material and to comply with prior informed consent and mutually agreed terms. To enable this, large institutions that maintain a number of databases, such as NCBI, should take a proactive role and guide database operators and users by developing codes of conduct. Such codes should state how users of genetic resources can enter into contractual obligations with providers to use databases for effective ABS-transactions. Fifth, users with and without commercial intentions should, when feeding data into databases, always refer to the source species of the material and voluntarily provide data on the provider state. It is also important that users try to agree with providers of genetic resources about using biological databases to ensure monitoring and compliance. This could save users from onerous compliance obligations. Finally, states should strengthen and promote their taxonomic and biogeographic research bases and feed data into GBIF.

Notes 1 This chapter is based on the author’s PhD thesis, to be be published by Earthscan, London as Marine genetic resources, access and benefits sharing. Legal and biological aspects. 2 GenBank can be accessed via http://www.ncbi.nlm.nih.gov/nuccore, accessed 4 November 2011. 3 PubMed can be accessed via http://www.ncbi.nlm.nih.gov/pubmed, accessed 4 November 2011. 4 GBIF can be accessed via data.gbif.org/welcome.htm, accessed 4 November 2011. 5 Ocean Biogeographic Information System, OZCAM, Canadian Museum of Nature, FishBase, Cornell University Museum of Vertebrates, University of Kansas Biodiversity Research Center, Natural History Museum at the University of Oslo, Royal Ontario Museum, University of Minnesota Bell Museum of Natural History, Field Museum, Centro National Patagonico, Texas Cooperative Wildlife Collection, Museum national d’histoire naturelle

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et Reseau des Herbiers de France, Ohio State University Insect Collection, Museum of Comparative Zoology at Harvard University, North Carolina State Museum of Natural Sciences, GBIF-Sweden, Yale University Peabody Museum, Tulane University Museum of Natural History, Los Angeles County Museum of Natural History, National Museum of Nature and Science in Japan, GBIFSpain, Museum of Natural and Cultural History at University of Oregon, University of Colorado Museum of Natural History, University of California, Museum für Naturkunde Berlin, Arctos, TELDAP, NatureServe, Administración des Parques Nacionales in Argentina, Danish Biodiversity Information Facility, University of Alberta, US Geological Survey, ArtDatabanken, Musée national d’histoire naturelle Luxembourg, UK National Biodiversity Network, National Biodiversity Data Centre, Senckenberg, University of Navarra Museum of Zoology, Institute of Nature Conservation at Polish Academy of Sciences, BeBIF Provider, Michigan State University Museum, GEO-Tag der Artenvielfalt, Zoologisches Forschungsinstitut und Museum Alexander König, and University Museum of Zoology Cambridge. 6 Note that the maps contain records with mappable coordinates only. Records without coordinates but which are attributable to discrete countries can be found within the ‘countries with occurrences’ section on each species overview page in GBIF. 7 In fact, initial informal negotiations have started on developing such a mechanism for genetic resources occurring in the high seas and the seabed beyond national jurisdiction (IUCN 2011).

References Agarwal-Mawal, A, Du, SJ, Hew, CL, Yaskowiak, ES and Fletcher, GL (2004) ‘Direct submission’, GenBank: AY687640. Apweiler, R, Martin, MJ, O’Donovan and Pruess, M (2003) ‘Managing core resources for genomics and proteonomics’, Pharmacogenomics, 4 (3), 343–350. AquaBounty (2011) ‘AquaBounty fact sheet’, http://www.aquabounty.com/ documents/press/2010/AquaBounty%20Fact%20Sheet%20-%20Corfin.pdf, viewed 3 November 2011. Benoît, G and College, S (2006) ‘Bioinformatics’, Annual Review of Information Science and Technology, 39 (1), 179–218. Benson, DA, Karsch-Mizrachi, I, Lipman, DJ, Ostell, J and Sayers, EW (2010) ‘GenBank’, Nucleic Acids Research, 38, D46–D51. Biber-Klemm, S, Martinez, SI and Jacob, A (2010) Access to genetic resources and sharing of benefits. ABS program 2003 to 2010, Swiss Academy of Sciences, Bern. Carr, MH, Neigel, JE, Estes, JA, Andelman, S, Warner, RR and Largier, JL (2003) ‘Comparing marine and terrestrial ecosystems: implications for the design of coastal marine reserves’, Ecological Applications, 13 (1), 90–107. CBD GTLE information document UNEP/CBD/ABS/GTLE/1/INF/1, Good business practices and case-studies on biodiversity (2008). Chiou, PP, Khoo, J, Chun, CZ and Chen, TT (2007) ‘Transgenic fish’, in Meyers, RA (ed.) Genomics and genetics, Wiley-VCH, Weinheim. Galperin, MY and Cochrane, GR (2011) ‘The 2011 Nucleic Acids Research database issue and the online molecular biology database collection’, Nucleic Acids Research, 39, D1–D6.

284 Gorch Detlef Bevis Fedder Garrity, GM, Thompson, LM, Ussery, DW, Paskin, N, Baker, D, Desmeth, P, Schindel, DE and Ong, PS (2009) ‘Studies on monitoring and tracking genetic resources’, Information document of the Ad Hoc Open-Ended Working Group on Access and Benefit Sharing, UNEP/CBD/WG-ABS/7/INF/2. GBIF (2007) The GBIF data portal, GBIF, Copenhagen. Goodman, N (2002) ‘Biological data becomes computer literate: new advances in bioinformatics’, Current Opinion in Biotechnology, 13, 68–71. Hew, CL and Fletcher, GL (2001) ‘Gene construct for production of transgenic fish’, Patent EP 0578653-B, GenBank: AY687640. Hortal, J, Lobo, JM and Jiménez-Valverde, A (2007) ‘Limitations of biodiversity databases: case study on seed-plant diversity in Tenerife, Canary Islands’, Conservation Biology, 21 (3) 853–863. IUCN (International Union for Conservation of Nature) (2011) ‘IUCN-BfN International Seminar on Conservation and Sustainable Use of Marine Biodiversity Beyond National Jurisdiction’, http://www.iucn.org/about/work/ programmes/marine/marine_our_work/marine_governance/?8744/IUCNBfN-International-Seminar-on-Conservation-and-Sustainable-Use-of-MarineBiodiversity-Beyond-National-Jurisdiction, viewed January 2012. Köhler, J (2004) ‘Integration of life science databases’, DDT: Biosilico, 2 (2) 61–69. Lane, MA and Edwards, JL (2007) ‘The Global Biodiversity Information Facility’, in Curry, GB and Humphries, CJ (eds), Biodiversity databases: techniques, politics, and applications, CRC Press, Boca Raton. Morse, DE (1986) ‘Biotechnology in marine aquaculture’, Aquacultural Engineering, 5, 347–355. NCBI (2011) ‘PubMed Help’, http://www.ncbi.nlm.nih.gov/books/NBK3830, viewed 4 November 2011. Vanden Berghe, E (ed.) (2007) ‘The Ocean Biogeographic Information System: web pages’, http://www.iobis.org, viewed 10 November 2011. Wang, Y, Xiao, J, Suzek, TO, Zhang, J, Wang, J and Bryant, SH (2009) ‘PubChem: a public information system for analyzing bioactivities of small molecules’, Nucleic Acids Research, 37, W623–W633. Yaskowiak, ES, Shears, MA, Agarwal-Mawal, A and Fletcher, GL (2006) ‘Characterization and multi-generational stability of the growth hormone transgene (EO-1α) responsible for enhanced growth rates in Atlantic salmon’, Transgenic Research, 15, 465–480.

14 Knowledge commons, intellectual property and the ABS regime Gerd Winter

Introduction Knowledge about genetic resources accumulates daily. Much of it enters the public domain. The public domain is organized in many different forms, which can be ordered according to the degree of commonality, in other words the freedom to insert information into the systems and the freedom to take and use information from them. The commons character of the public knowledge domain contrasts with various kinds of knowledge privatization. The major instruments of privatization are copyright, trade secret protection, patent/breeders’ rights and – a more recent addition – sovereign rights over genetic resources. Privatization means that the producer of knowledge is entitled to control its utilization. According to ruling opinion, this right will reward and stimulate the production of knowledge. Others are concerned, increasingly in recent times, that instead privatization may hinder the progress of research and development. This chapter will explore, with a focus on knowledge about genetic resources, how the different privatization regimes relate to each other, and how a balance between reasons for a public domain and for privatization can be found. It will start by exploring the characteristics and problems of knowledge commons and proceed to discussing the instruments of and reasons for privatization, with a view to clarifying the specifics of the access to genetic resources and benefit sharing (ABS) regime.

Characteristics and problems of knowledge commons An advanced knowledge commons consists of a collection of information into which everyone can feed information and from which everyone can take information for unrestricted use. Knowledge commons are a variant of the ‘new commons’. While in the ‘old commons’, such as common grazing land or fisheries, the resource can be depleted and use is therefore rivalrous, in the informatic commons the use is non-rivalrous because utilizing information does not exhaust the information but rather enhances its content (Hess and Ostrom 2007).

286 Gerd Winter This means that the task for the management rules is less difficult than if, for instance, grazing times and intensity on communal land must be allocated and supervised. While in the old commons, the resource utilized by members (the grazing land or the fish stock) is normally the common property of them or the state, this is not necessarily so in the case of knowledge commons. The resource (information) can be private intellectual property if the proprietor feeds it into the common pool on the agreement that it can be used without restriction. However, the pool may require that only information which is not subject to IPRs will be entered into the collection. Knowledge commons, however, resemble the old commons in respect of the free-rider problem. There can be persons who wish to make use of the knowledge but try to avoid feeding their own knowledge into the system. Thus, the possibility of excluding free-riding persons must be ensured. While in the old commons this can be organized by physical exclusion of users, it is more difficult in knowledge commons. It is true that by technically closing data processing media information can be kept secret, but there are many ways to circumvent barriers, and once the information has escaped, it easily spreads around. A third problem is the possibility of unequal use of the communal resource. It frequently arises in the old commons when, for instance, industrial vessels exploit a coastal fishery together with small vessels. This has sometimes been prevented by reserving the coastal area for artisanal fishery or by supporting investment more efficiently (Winter 2009). As for the knowledge commons, the non-rivalry of information use works against such unequal exploitation. There is nonetheless a similar kind of inequity in that the bulk of research on genetic resources is conducted by researchers from developed countries whilst researchers from developing countries often lack the infrastructure and expertise to keep pace. It is, therefore, crucial for knowledge commons to install a mechanism of special support for the developing countries. Another characterizing dimension is the geographic scope of a commons. In the old commons, the resource is normally local, whereas knowledge is geographically unlimited, both by its very nature and by its major carrier, the print and electronic media. In regulatory terms, this means that other than in the old commons, any management rules for the commons will be concerned with many jurisdictions and legal cultures. The final dimension of comparison is the possibility that parts of the pooled resource (to which the user may have contributed or not) are appropriated. This is not problematic in the old commons, because it is part of their rationale that products resulting from the use of the common goods can be sold. For instance, it is part of the institutional setting of common fisheries that the fish caught from a common fish stock can be sold by the individual fisherman. The price is more or less known to and accepted by the pool members, and it is clear to them that with the sales the product leaves the

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pool. However, the situation is different with knowledge commons. The genetic resource can remain in the pool even if individual samples are sold or given away. A user may, however, discover that the genetic resource is of extraordinary economic value and seek a permanent monopoly over it by intellectual property protection. The commons must then decide whether to allow this or to require benefit sharing with the pool and/or the provider of the information. This is the question that will be examined in more detail in the remainder of this chapter.

Phenomenology of biological knowledge commons In order to understand better the characteristics and problems of knowledge commons in the realm of genetic resources, some examples of such commons will be presented. Knowledge commons can be pure pools of information, and they can exist side by side with commons of genetic material. Commons of genetic material comprise ex situ collections and exchange networks of biological resources (such as botanical gardens and microbial culture collections), exchange networks of individual holders of ex situ resources (such as plant and animal breeders), as well as exchange networks of holders of in situ resources (such as local seed fairs1). Most of them are intended to facilitate the exchange of specimen for research and further development.2 Often the material collections are combined with information pools related to the material. These are usually also openly accessible.3 However, the bulk of information on biological resources is contained in pools detached from material collections. These pools will form the focus of the remainder of this chapter. The content of knowledge pools which is of interest in our context can be the following: • • •

scientific organismic and biological taxonomy (i.e. knowledge about the organism and its life conditions and functions); traditional knowledge on organisms and their functions; genomics, proteomics and metagenomics (i.e. the knowledge about the genome and the functions of genes and proteins).4

In terms of carrier, print media have until recently been the most popular. While the form the author gave to the information is protected by copyright, the information content published in this way has been free for any use. Informal rules of professions ensure that the use of information must be acknowledged by citation of the source. Researchers are motivated to publish their intellectual products by the prestige conveyed by being read and cited. Of course, the material interest of getting a job and being paid is behind this incentive, but it is tied to the immaterial interest because the entrance preconditions for jobs are often related to the scientific standing of the applicant.

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Print media are increasingly being complemented and even replaced by electronic media. Many journals and books publish electronic versions of their articles; others appear only in that way. However, much information is not sufficiently original or is too voluminous for publication in article and book format, such as sequenced genomes of organisms or the compilation of already published information. For this purpose, more and more electronic databases have been set up. Databases also contain original information but publication through a journal or book has continued to be more highly esteemed because of quality standards and peer reviewing. Some examples of databases will be sketched out, most of them public and one private. Public databases Scientific knowledge about biological resources Since biological science emerged, innumerable collections of knowledge about biological resources have developed. Traditionally this has been done in printed form, but for several decades electronic databases have been built up. One example is the Global Biodiversity Information Facility (GBIF). Its mission statement reads that GBIF ‘promotes and facilitates the mobilization, access, discovery and use of information about the occurrence of organisms over time and across the planet.’5 It is funded by public monies and runs a database on the taxonomy and occurrence of a large and fast increasing number of species. The use of the database is free and unrestricted but subject to the obligation that the database is mentioned as a source in publications. Those who provide data to the database must agree to unrestricted access to the data and ensure that the data are not subject to any intellectual property protection. Traditional knowledge about biological resources The most original variants of traditional knowledge (TK) pools are networks and communities of healers, farmers and local populations who generate, exchange and collect knowledge about biological resources.6 They are traditionally open for any person contributing and allow use by anyone free of charge or in return for up-front compensation by payment or barter for equivalent TK. In some countries, systematic collections have been built up, first in printed form and more recently in electronic databases. One example of the latter is the Traditional Chinese Medicine Database System, which compiles a large number of pre-existing Chinese medicine databases. Access is possible after registration and against an up-front payment, which is used to cover the cost of maintenance of the system. The user does not have to sign an agreement or disclose the aim of use.7

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Genomics GenBank sequence database8 is run by the National Center for Biotechnology Information (NCBI) at the National Library of Medicine (NLM), National Institutes of Health (NIH), USA. It is part of the International Nucleotide Sequence Database Collaboration (INSDC), which also includes the DNA Databank of Japan (DDBJ) and the European Molecular Biology Laboratory (EMBL). GenBank has a collection of annotated sequences of DNA and RNA.9 The sequences included in the database stem from more than 100,000 organisms. GenBank entries include a description of the sequence, the scientific name and taxonomy of the source organism and a table of features that identifies coding regions and other sites of biological significance. Protein translations for coding regions are included in the feature table. Bibliographic references are included along with a link to the Medline unique identifier for all published sequences. Sometimes, but not in all entries, the geographic location of the sequenced specimen is also noted. The most important source for entries into GenBank is scientists. It is the responsibility of submitters to ascertain that they have the right to submit the data. The base does not attach statements to records that restrict access to the data, limit the use of the information in these records, ask for payment of licence fees or prohibit certain types of publications based on these records. Corrections of errors and updates of the records by authors are possible and erroneous records may be removed from the next database release. Anyone is free to search for and download data. The purpose of use of the data is unrestricted. It is, however, required that GenBank, if used for research, is cited as a source in any publication of research results. Proteomics The Universal Protein Knowledge Base (UniProtKB)10 is operated by the Swiss Institute of Bioinformatics and the European Bioinformatics Institute. It is funded by the US National Institutes of Health (NIH), the European Commission and the Swiss government. It contains a collection of protein sequence data. It is considered to be the world’s most comprehensive database on protein information. It has two parts, UniProtKB/Swiss-Prot and UniProtKB/TrEMBL.11 The first strives for a high level of annotation (such as the description of the function of a protein, its domains structure, post-translational modifications, variants, etc.), a minimal level of redundancy and a high level of integration with other databases. The second is a computer-annotated supplement of SwissProt that contains unreviewed protein sequences associated with computationally generated annotation and large-scale functional

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characterization. Every UniProtKB/Swiss-Prot entry contains the amino acid sequence, protein name or description, taxonomic data and citation information, and as much annotation as possible. The source can be animals, plants, microorganisms, viruses etc. The source organism is listed, but not the geographic location of the species or the sample taken for sequencing. More than 99 per cent of the protein sequences provided by UniProtKB are derived from the translation of the coding sequences (CDS) which have been submitted to the public nucleic acid databases, the EMBL-Bank/GenBank/DDBJ databases (INSDC). These CDS are either generated by gene prediction programs or are experimentally proven. A protein identifier (‘protein_id’) is assigned to the translated CDS and can be found in the original EMBL-Bank/ GenBank/DDBJ record and in the relevant UniProtKB entry. All these sequences, as well as the related data submitted by the authors, are automatically integrated into UniProtKB/TrEMBL. The TrEMBL records can be selected for further manual annotation and then integrated into the UniProtKB/Swiss-Prot section. On the user side, everyone has free access to the databases for unlimited purposes. Even the patenting of a protein and its function is permitted. However, the availability of the information from the database may be regarded as prepublication under patent law. Meta-databases The word ‘meta’ is commonly used to define data about data, in other words an upper level of data about a lower level of data. For instance, data about the methodology of sampling and researching an organism would be metadata of the data about the organism itself. The more first level databases develop, the more important it is to create meta-databases that combine them and provide criteria and tools for targeted searches. This is particularly crucial in microbiology. The microbial genomics data have exponentially grown since the advent of metagenomics, i.e. genomic research that targets not only cultivated samples but also non-cultivatable samples taken directly from of the natural environment and representing the huge microbial diversity in the same.12 A publicly funded database compiling and making data from such research publicly accessible is, for instance, run by the Community Cyberinfrastructure for Advanced Microbial Ecology Research and Analysis (CAMERA).13 Another one which is still under construction is StrainInfo. It is publicly funded and publicly accessible (Dawyndt 2011).14 Commercial databases BIOBASE15 is an international bioinformatics company headquartered in Wolfenbüttel, Germany. Its focus is on the generation, maintenance and

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licensing of biological databases and their connected software platforms. All BIOBASE databases provide manually curated content. BIOBASE staff collect and structure the required data from peer-reviewed scientific primary publications. One of the databases operated by BIOBASE is called TRANSFAC®. It compiles published data on eukaryotic transcription factors, their experimentally proven binding sites and regulated genes. Transcription factors are important components of signalling cascades controlling all types of normal cellular processes as well as response to external stimulus, conditions of disease drug treatment, and more. The database contains up-to-date transcription regulation details from the PubMed literature on more than 300 species, with a focus on humans, mice, rats, yeast, worms and plants. It is organized in a one-report-per-protein format. Access is not free but rather provided after the payment of a fee. The user is not allowed to permit third party access to the database, must keep any proprietary information taken from the database undisclosed, limit access to the database to employees who have agreed in writing to maintain the proprietary information in confidence, and may not transfer any right to any third party without the prior written consent of BIOBASE.

Knowledge commons and privatization The public domain character of knowledge pools stands in contrast with different kinds of privatization possibilities and efforts, three of which are crucial: copyrights of text producers, patent/breeders’ rights/trade secrets of information producers, and sovereign rights of resource providers.16 We will discuss them in turn. Copyright By providing copyright, states reward those who have created original work. The protection relates to the form of the work, not its substantial idea.17 In most jurisdictions, the right comes into being by the very creation of the work18, while in the USA it must be registered, which is facilitated because it is made by mere declaration to the competent authority. The copyright provides the power to exclude anyone from reproducing, adapting, distributing, performing, displaying, communicating and translating a work. Creators of databases are also granted the copyright if the selection or the arrangement of its content is an intellectual creation.19 Much of the present discussion on databases of genetic resources is concerned with creating commons and defending them against enclosures by copyright holders (Uhlir 2011). The maintenance of commons is possible because the law does not prevent the holder of the copyright from providing a general licence or even from waiving his/her copyright. Such a waiver is proposed by the Creative Commons network. The most far-

292 Gerd Winter reaching version is contained in the declaration called CC0, which reads as follows: To the greatest extent permitted by, but not in contravention of, applicable law, Affirmer hereby overtly, fully, permanently, irrevocably and unconditionally waives, abandons, and surrenders all of Affirmer’s Copyright and Related Rights and associated claims and causes of action, whether now known or unknown (including existing as well as future claims and causes of action), in the Work (i) in all territories worldwide, (ii) for the maximum duration provided by applicable law or treaty (including future time extensions), (iii) in any current or future medium and for any number of copies, and (iv) for any purpose whatsoever, including without limitation commercial, advertising or promotional purposes (the ‘Waiver’). Affirmer makes the Waiver for the benefit of each member of the public at large and to the detriment of Affirmer’s heirs and successors, fully intending that such Waiver shall not be subject to revocation, rescission, cancellation, termination, or any other legal or equitable action to disrupt the quiet enjoyment of the Work by the public as contemplated by Affirmer’s express Statement of Purpose.20 Looking at the reasons why researchers waive their copyrights, it seems that non-monetary considerations such as prestige and the pleasure of enhancing common knowledge are often stronger than monetary incentives, which are difficult to calculate anyway. Sometimes, a monetary reward can even be counterproductive in a collaborative network (Dedeurwaerdere 2010). Of course, there are limits to the willingness of actors to fully integrate their work into knowledge commons. There are legitimate reasons, for instance if the author makes his/her living out of the production of knowledge. BIOBASE is an example of this. They provide the service of screening published data for genetic transcription factors. It is understandable that they claim copyright in order to be paid by customers. The interest of publishers in having the copyrights transferred and used in order to cover the cost of publishing is also legitimate. Cases in which an author makes use of a freely accessible database and keeps his/her results secret are more problematic. This impoverishes the content of the collection in the long run. The researcher should at least be asked to provide results if the research is publicly funded.21 If not, that is if the research aims at commercial products, keeping results secret is understandable, but researchers should then pay fees for data access. In any case, the user of a database should be obliged to make reference to it if his/her research is based on it. This is, for instance, the policy of NIH in relation to the databases run under its auspices (Sheehan 2011: 103).

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Patent and breeders’ right; trade secrets While copyright is aimed at enhancing the cultural sphere, patent and breeders’ rights are intended to enrich the economic sphere. This is reflected in the requirement (not applicable to copyright) that the information content to be patented must be capable of industrial application. Somewhat similar to the copyright precondition of originality, the information must be an invention and a novelty.22 In contrast to copyright, the content of the information, not its form is patented. The breeders’ right, which is an exclusive right on plant varieties, resembles the patent right but is somewhat less demanding in its preconditions. Novelty remains a precondition while industrial applicability is replaced by the more concrete criteria that the variety must be distinct, uniform and stable. Inventiveness is not required. Trade secret protection is also a kind of intellectual property protection. It is akin to the patent and breeders’ right, because it is also related to the commercial value of information content and grants the holder an exclusive use right. It is more roughly shaped, however, because the preconditions of protection are less precise and the protective apparatus less sophisticated. Knowledge commons on genetic resources are constricted both by copyrights and by patent/ breeders’ rights/trade secrets. While the intellectual effort of creating the form of the information (i.e. the research article or database) is rewarded by the copyright, the other rights reward the intellectual effort of inventing a new and useful idea. In a sense, the data commons is thus undermined by two sorts of privatization, the privatization of the form and of the content.23 The challenge from patent/ breeders’ rights is, however, more consequential because licence payments are normally higher, and the uses allowed by law more restricted than with copyrights. The reason for this is that usually the industrial application of the idea content yields more income than the publication of idea forms. The higher value of the right content is also reflected in the fact that patent and breeders’ rights are granted by law but also individually issued so that the competent authority can check whether the preconditions are met. There are two major challenges for the knowledge commons from patent/breeders’ rights. One is the extension of the right. Patents can be obtained for DNA sequences if their function was discovered. Recent research has revealed that many DNA sequences cross-sect over many species. This means that if one sequence is patented, the right spans very widely. The realm of knowledge commons can thus be severely restricted (Oldham 2005). The other challenge is free-riding. Users with commercial intentions may draw the benefit of free information from the database but not submit their own R&D results. It is true that the submission of results may not be fitting if they are from applied research and the database only collects

294 Gerd Winter basic research data. But this is not necessarily so. Knowledge commons could well develop in the direction of applied research. For instance, as shown above, most of them already collect data on the transcription of genes into proteins, which could be classified as results from applied research. They may even decide to extend themselves to patentable products like, for instance, genetically modified microorganisms. The law, of course, does not compel researchers to apply for patenting or breeders’ rights. They can decide not to do this. The knowledge commons may provide incentives in that direction. The multilateral system may be taken as an example here. It frees the breeders of varieties taken from the system from paying royalties into the system if they do not exclude others from the use of the new variety.24 A similar incentive could be provided by public databases. They could limit free access to noncommercial research (which may be defined as research aiming at enriching the public domain) and require commercial research to pay a fee or even royalty payments into the system. Apart from the voluntary decision of breeders not to claim intellectual property, the danger of capture of the public domain can also be reduced by appropriate legal precautions (Rimmer 2008). One is connected with the novelty criterion. A patent or breeders’ right is not granted if the information was already public. Thus, for instance, should a researcher download information on the coding of a gene from a public database, this could not be patented because it was already available in the database. Further legal mechanisms should be developed to exclude the sweeping scope of patent rights. This could be done by raising the thresholds for the patent preconditions of inventive step and utility and for the breeders’ right precondition of usefulness, as well as by restricting the protective scope of rights so that further R&D remains possible if working within the public domain. As a radical solution, patents could be refused on any natural life form. After all, genes are not invented but discovered. As an alternative to abstaining from searching property, the producer of the information can also opt for obtaining a patent/ breeders’ right and either allow free use of the information (as in the case of the Creative Commons licence of copyright holders) or feed it into an IPR pool he/she forms with other right holders. Realistically, however, there is usually hardly any incentive to do this.25 ABS rights The right of provider states to control access to genetic resources (GR) and ask for benefit sharing (in short, ABS rights) is a relatively new constraint for material and knowledge commons on GR. Since the Convention on Biological Diversity (CBD) came into force in 1993, and subject to pertinent national legislation, states have sovereign rights to legislate that their GR can only be accessed (and exported, if the case may be) with

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prior informed consent of the provider state and according to conditions laid down in a permit or access agreement.26 If they do so this is a form of privatization that adds up to the other forms already presented. I will first clarify the similarities and differences of ABS rights in relation to these other rights and then discuss how the additional challenge can be handled by the knowledge commons. ABS and the other privatization rights ABS rights and duties are to be given precise shape by national legislation of provider and user states. The legal relationships created are between the state and individuals as well as between individuals. The content of these legal relationships is located somewhere between real and intellectual property, with more affinity to the latter. As with any property right, the holder of the genetic potential of organisms (or information about it) is given the power to exclude others from using the resource or information. If compared with other intellectual property rights, ABS rights are more akin to patenting than to copyright, because some content, namely the genetic potential, rather than a form is protected. In both cases – patent/ breeders’ rights and ABS rights – the object of the exclusive right is a peculiar mixture of real things (the genetic potential) and information (the knowledge about the real thing).27 However, ABS rights also differ from patent rights in important respects. Other than patent rights (and more similar to copyrights) they arise ‘automatically’ by international convention and, internally, by national legislative act – in other words, they are not dependent on an administrative decision (provided the national legislator does not decide otherwise). The value for which the asset is protected is not only commercial but also ecological, cultural and scientific. Most importantly, however, while patent rights reward the inventive effort of the right holder, thus reflecting the labour theory of property, ABS rights are provided without any concern for whether an effort was made by the provider state. It suffices that the resource is found in situ in the provider state or ex situ in a collection. The theoretical background for this is a property theory based on simple possession. Such possession was recognized as a legitimate title by the international community, which is party to the CBD, just as simple possession has long been recognized for minerals, biological resources, etc. In other words, ABS rights are tied to the raw material possessed by a state while patent rights are based on its further development. The fact that one and the same genetic resource can be subject to two exclusive rights – one for the raw status and one for the ‘sophisticated’ status of the genetic resource – puts them in conflict with each other. This conflict was intended, as ABS rights were designed to build a counter position of resource states against a one-sided privatization of the resource by developed states. This must be kept in mind in any analysis of knowledge commons.

296 Gerd Winter ABS rights and knowledge commons As stated above, from the perspective of preserving the knowledge commons, ABS rights are a threat to privatization just as patent rights are. More precisely, the challenge is that provider states may, by controlling access, also determine what kind of research and development activities are allowed. They have good reason to do this because the curtailing of R&D is a promising strategy to master the difficulties of tracking down benefit-generating processes in user states (see Chapter 1). On the other hand, resource states have a fundamental interest in encouraging research and development, and involving themselves in these activities to develop their own capacities. They are thus bound by a dilemma: they will want to support the commons in order to share in the non-monetary benefit of R&D, but they will also want to confine the commons in order to ensure their shares in monetary benefits. Before discussing how this dilemma can be solved without restricting the commons, however, the extent to which it is true that knowledge of GR is under the command of the ABS regime must be clarified. We must ask whether any information on a genetic resource, be it taxonomic, genomic or functional, is legally under the disposition of the provider state. The question, under the heading of ‘derivatives’, was much discussed in the run-up to the Nagoya Protocol. The Protocol itself presents a solution: Article 2 defines derivatives as ‘a naturally occurring biochemical compound resulting from the genetic expression or metabolism of biological or genetic resources, even if it does not contain functional units of heredity’. The chemical compounds encoded by the genes are thus included in the scope of applicability of the ABS regime. However, derivatives are made part of the term ‘utilization of genetic resources’ by Article 2 NP, and not of the term ‘genetic resources’ itself. This means that the sovereign rights to govern access to GR do not cover chemical compounds. For instance, the provider state cannot claim through its national legislation that, without any specific administrative act or contract, any chemical derived from a GR is subject to its own disposition. Nevertheless, it is possible for the provider state to achieve this same effect with other methods. Access control can be used not only to fix the conditions of access to GR, but also to determine the conditions of utilization of GR. Thus, the provider state can introduce legislation requiring that conditions will be included in any access permit or access contract that define the allowed utilization and handling of R&D results. If this is implemented in the individual case, the resulting knowledge can only be used as determined by the permit and/or contract. If, for instance, the relevant conditions require that the researcher does not submit the research results to the public domain, or, on the contrary, that he/she may only seek patent protection upon approval by the provider state, he/she must obey these rules.28

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An objection to this very far reaching construction of access control is that the provider state’s grip on the GR should expire in some way during the often very long and highly branched chain of R&D from initial access up to the final product. Indeed, any other intellectual property regime does accept various kinds of limits. A look at such limits may provide reasonable analogies. While patent and copyrights expire after certain time periods, this is clearly not foreseen in the ABS regime. There is a case for introducing this kind of expiry time in the ABS regime. Likewise, a patent and a breeders’ right does not exclude someone using the protected object or information in order to develop a new object or idea.29 If transferred to the ABS regime, it can be argued that if someone uses the information about a gene that ‘belongs’ to a provider state to construct a different gene, he/she is free of any intervention by the provider state. The situation may be different and an analogy excluded if the genetic potential of an organism is still present in the derived product, such as in the case of breeding or genetic modification. By contrast, if a DNA sequence found in a certain organism can be synthesized, this should not be regarded as removing it from the disposition right of the provider state. Finally, the doctrine of exhaustion of intellectual property rights might provide an analogy. For instance, if a product derived from a GR is sold, the use and resale of the product should be free from the reach of the provider state’s right. Details of such delineations should be worked out by pioneering national legislation or guidelines that further specify the Nagoya Protocol. Given the fact that, on the whole, the provider states’ ABS rights reach rather far, those who advocate the knowledge commons are once again under pressure to offer provider states incentives for waiving their rights. As said before, as to the R&D activities themselves and the R&D results, provider states will normally have self-interest to support communal forms because this gives them the chance to develop their own R&D capacity. Should a provider state prefer to keep the research result to itself, the knowledge commons could take note of that and tighten up access to the commons for this state, for instance by requiring it to pay user fees. This may persuade the provider state to allow R&D results from its GR to be submitted to the commons. However, concerning the privatization of R&D results by patent/breeders’ rights, trade secrets and the exclusive bringing to the market of products, the provider state will legitimately wish to introduce effective measures to secure its special share in the resulting monetary benefits. There are three ways of acceding to this request without fundamentally eroding the knowledge commons (cf. Halewood and Louafi 2012). One is to introduce conditions for the use of data, requiring that any commercial use must first be agreed with the provider state. Concerning submissions of data to databases, the database organisation could be required to ask for disclosure of the country of origin of the sample from which the data were derived. In addition, in order to enable the tracking back and forth of R&D

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processes, unique and interchangeable identifiers of genes and tools to connect information would have to be developed (see Chapter 13; Garrity et al. 2009). Such tracking information could enhance the effectiveness of the requirement to disclose origin in patent applications or at other commercialization stages (Cabrera Medaglia 2010; Kamau 2009). A second possibility would be to make database organizations responsible for supervising use and collecting and redistributing shares in monetary benefits. This would mean that not only non-monetary but also monetary benefits are included in the common pool. However, the first – and even more the second – option would cause high transaction costs, and the databases would be loaded with heavy organizational tasks. Therefore, much speaks in favour of a third solution that has often been rebuffed but may nevertheless prove to be most reasonable and best manageable: the biodiversity charge. Under this scheme, any remuneration for the sales of a product, for a patent or breeders’ licence or for the rendering of a service would be subject to the payment of a tax if the value-generating object or activity is based on genetic resources (or TK). Details would, of course, be elaborated, e.g. on the kinds of GR and TK and R&D processes triggering the charge as well as how high it should be. The money would flow into a worldwide fund, possibly managed by the Global Environmental Facility, or into a number of funds concerned with various GR species. Funds would be allocated according to criteria yet to be developed, which would on the one hand aim at supporting the conservation of biodiversity, and on the other hand reward those states who have provided GR that finally enrich the material and knowledge commons. The charge would, however, be detached from the individual provider state, i.e. the state that provided the individual sample or specimen for R&D. Therefore, in the R&D process, the origin of this specimen would not have to be registered where it is not necessary for scientific reasons. Thus, transaction costs could be reduced. At the same time, the concern about ‘horizontal’ equity would be solved (see Chapter 1). Funds could flow to the most relevant host states of GR rather than to the state that, by chance, was the one in which the GR was accessed. Of course, this alternative to the burdensome monitoring of R&D processes would require the conclusion of a new multilateral agreement and thus the consensus of many states and interest groups.

Notes 1 For examples see Chapters 5 and 12. 2 See Chapters 10 and 17. 3 Recently, collections have been building up more comprehensive information pools. See Chapter 11. 4 The functional information is particularly valuable because it allows products to be developed on the basis of the GR. It includes, as Garrity et al. (2009: p. 6) state, ‘functional or regulatory pathways, structural polymers or biological

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10 11 12 13 14 15 16 17 18 19

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functions of an organism that are encoded for by the genetic material, including metabolic products that have some practical applications (e.g., low molecular weight organic acids; anti-microbial agents, such as antibiotics, and other biopharmaceuticals, flavors and fragrances, enzymes for industrial applications)’. http://www.gbif.org, viewed 28 January 2013. For further details, see Chapter 13. See the case studies in Chapters 2, 3, 4 and 5. See Chapter 8. The following description is compiled from the GenBank website, http://www. ncbi.nlm.nih.gov/genbank, viewed 28 January 2013. Deoxyribonucleic acid (DNA) is a macromolecule carrying the information for the development and functioning of an organism. Ribonucleic acid (RNA) is a macromolecule that helps to translate DNA information into the synthesis of proteins. The following description is compiled from the UniProt/KB website, http:// www.uniprot.org/help/uniprotkb, viewed viewed 28 January 2013. TrEMBL means Translated EMBL Nucleotide Sequence Data Library. EMBL is the European Molecular Biology Laboratory. The term was introduced by Handelsman et al. (1998); cf Wikipedia article on Metagenomics. http://camera.calit2.net, viewed 28 January 2013. See Sun et al. 2011. http://www.straininfo.net, viewed 28 January 2013. The following description is based on the BIOBASE website, http://www. biobase-international.com, viewed 28 January 2013. Geographical indications could be considered as a fourth (see Correa (2010) for a recent report on this discussion) but will be excluded from further analysis. Article 2, WIPO Copyright Treaty states: ‘Copyright protection extends to expressions and not to ideas, procedures, methods of operation or mathematical concepts as such.’ Article 5 (2) Berne Convention for the Protection of Literary and Artistic Works: ‘The enjoyment and the exercise of these rights shall not be subject to any formality.’ See Article 5 WIPO Copyright Treaty: ‘Compilations of data or other material, in any form, which by reason of the selection or arrangement of their contents constitute intellectual creations, are protected as such. This protection does not extend to the data or the material itself and is without prejudice to any copyright subsisting in the data or material contained in the compilation.’ http://creativecommons.org/publicdomain/zero/1.0/legalcode, viewed 28 January 2013. It is controversial if the law in all states allows such a waiver. For these cases Creative Commons proposes to add to the waiver a declaration by which the right holder provides a general licence to any user. Since the 1990s a counter-tendency has emerged. Universities ask for nondisclosure in order to allow for patenting the research result. There is a longerstanding practice of governments keeping results secret for political reasons. Article 27.1, Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement). It should be kept in mind that the information content of the public domain as such is not shrinking as a result of patent rights because they require the right holder to disclose the information. In that respect, patenting is better than keeping information as a trade secret (Dinwoodie and Dreyfuss 2006: 198). However, the usability of the information is severely restricted. As free

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utilization is one of the intentions of many commons, this is, of course, a challenge for them. See Chapter 17. See Chapter 9. Encouraged by the International Treaty on Plant Genetic Resources for Food and Agriculture, Article 9, states can also introduce protection of local landraces by establishing sui generis farmers’ rights. See Chiarolla, Louafi and Schloen (2013: 93, 110). Sometimes the distinction between the real thing and the information about it is not accepted. See, for instance, the definition of genetic resources by Garrity et al. (2009: p. 14) which reads: ‘Genetic resources are essentially “packets of informational goods” that are presented as biological material (e.g., an entire specimen, a leaf, skin, etc.) and include DNA and RNA molecules as well as gene or protein sequences.’ In my view, this definition does not lead to a clear understanding. I believe that the reality of a DNA string with all its potentialities must still be distinguished from the information representing this reality. In other words: the perfect description of a gene in silico does not bring the gene to life. It is true, however, that the provider state when designing conditions is not allowed to exaggerate; it must respect its obligation under Article 15.2 CBD also to ‘endeavour to create conditions to facilitate access to genetic resources for environmentally sound uses’. What that means exactly is still open for discussion. Traditionally, non-commercial users could claim to freely use the patented information or object for scientific purposes. But this defence has recently been curbed by court jurisprudence on the grounds that universities nowadays also aim to secure intellectual property (Dinwoodie and Dreyfuss 2006: pp. 204, 206).

Bibliography Cabrera Medaglia, J (2010) ‘The disclosure of origin requirement in Central America: legal texts, practical experience and implementation challenges’ in Gesellschaft für Technische Zusammenarbeit (ed.) Triggering the synergies between intellectual property rights and biodiversity, GTZ Eschborn, pp. 270–292. Chiarolla, C, Louafi, S and Schloen, M (2013), ‘An analysis of the relationship between the Nagoya Protocol and instruments related to genetic resources for food and agriculture and farmers’ rights’, in Morgera, E, Buck, M and Tsioumani, E (eds), The 2010 Nagoya Protocol on access and benefit-sharing in perspective, Martinus Nijhoff, Leiden and Boston, pp. 83–122. Correa, CM (2010) ‘Strengtheneing the TRIPS-CBD relationship: is a compromise deal possible at the WTO?’ in Gesellschaft für Technische Zusammenarbeit (ed.) Triggering the synergies between intellectual property rights and biodiversity, GTZ Eschborn, pp. 52–68. Dawyndt, P (2011) ‘StrainInfo: reducing microbial data entropy’, in Uhlir, PF (ed.), Designing the microbial research commons: proceedings of an international symposium, The National Academic Press, Washington DC, pp. 115–120. Dedeurwaerdere, T (2010) ‘Institutionalizing global genetic resource commons: towards alternative models for facilitating access in the global biodiversity regime’, SSRN working paper (19 May 2010), http://ssrn.com/abstract=1611549, viewed 28 January 2013.

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Dinwoodie, GB and Dreyfuss, RC (2006) ‘Patenting science: protecting the domain of accessible knowledge’, in Guibault, L and Hugenholtz, PB (eds), The future of the public domain: identifying the commons in information law, Kluwer Law International, Alphen aan den Rijn, pp. 191–221. Garrity, GM, Thompson, LM, Ussery, DW, Paskin, N, Baker, D, Desmeth, P, Schindel, DE and Ong, PS (2009) ‘Studies on monitoring and tracking genetic resources’, Background paper for the seventh meeting of the Ad Hoc Openended Working Group on Access and Benefit-sharing, Paris, 2–8 April, http:// www.cbd.int/doc/meetings/abs/abswg-07/information/abswg-07-inf-02-en. pdf, viewed 28 January 2013. Halewood, M and Louafi, S (2012) ‘Introduction’, in Halewood, M, López Noriega, I, Louafi, S (eds), Crop genetic resources as global commons: challenges in international law and governance, Earthscan, London, pp. 1–34. Handelsman, J, Rondon, MR, Brady, SF, Clardy, J and Goodman, RM (1998) ‘Molecular biological access to the chemistry of unknown soil microbes: a new frontier for natural products’, Chemistry and Biology, 5 (10): R245, doi:10.1016/ S107-521(98)9010-. Hess, C and Ostrom, E (2007) Understanding knowledge as a commons: from theory to practice, MIT Press, Cambridge, MA. Kamau, EC (2009) ‘Disclosure requirement – a critical appraisal’ in Kamau, EC, Winter, G (eds) Genetic resources, traditional knowledge and the law. Solutions for access and benefit sharing, Earthscan, London, pp. 399–418. Oldham, P (2005) ‘Global status and trends in intellectual property claims: genomics, proteomics and biotechnology’, Submission to the Executive Secretary of the Convention on Biological Diversity, UNEP/CBD/WG-ABS/3/ INF/4, http://www.cbd.int/doc/meetings/abs/abswg-03/information/abswg03-inf-04-en.pdf, viewed 28 January 2013. Rimmer, M (2008) Intellectual property and biotechnology: biological inventions, Edward Elgar, Cheltenham, UK, Northampton, MA. Sheehan, J (2011) ‘Toward a biomedical research commons: a view from the National Library of Medicine at the National Institutes of Health’, in Uhlir, PF (ed.), Designing the microbial research commons: proceedings of an international symposium, The National Academies Press, Washington DC, pp. 103–110. Sun, S, Chen, J, Li, W, Altintas, I, Lin, A, Peltier, S, Stocks, K, Allen, EE, Ellisman, M, Grethe, J and Wooley, J (2011) ‘Community cyberinfrastructure for advanced microbial ecology research and analysis: the CAMERA resource’, Nucleic Acids Research, 39, Issue suppl 1, D546–D551. Uhlir, PF (2011) ‘Designing the digital commons in microbiology – moving from restrictive dissemination of publicly funded knowledge to open knowledge environments: a case study in microbiology’, in Uhlir, PF (ed.), Designing the microbial research commons: proceedings of an international symposium, The National Academies Press, Washington DC, pp. 77–90. Uhlir, PF (ed.) (2011a) Designing the microbial research commons: proceedings of an international symposium, The National Academies Press, Washington DC. Winter, G (ed.) (2009) Towards sustainable fisheries law: a comparative analysis, IUCN, Gland, Switzerland.

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Part IV

International approaches

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15 ABS, justice, pools and the Nagoya Protocol Peter-Tobias Stoll

The CBD’s ABS system is often and probably correctly seen as intending to bring benefits to developing countries as a matter of justice. The idea of pools1 is linked to an understanding of a joint management of resources, which allows the objectives of justice to be pursued in this way. As the ABS system still has a number of deficiencies2, the idea of pools is itself a topic for further consideration (Winter 2009: 19–35). It might also be useful to consider whether the Nagoya Protocol supports such a concept.

Justice and the CBD ABS system Justice plays a pertinent role in the lengthy discussions, negotiations and efforts aimed at its implementation, and is part of the many interpretations and expectations related to the subject (Jonge and Louwaars 2009: 37–56 passim; Stoll 2009: 8). In addition, the CBD itself alludes to the concept of justice explicitly as well as by implication. As is sometimes observed, these claims to justice are far from clear. Some clarification is needed at this point. Fairness, equity, participation, sharing and technology transfer – the CBD’S explicit claims for justice The CBD’s text is quite explicit on justice. This is already apparent in Article 1 of the Convention which calls for ‘fair and equitable sharing of the benefits arising out of the utilization of genetic resources, including by appropriate access to genetic resources and by appropriate transfer of relevant technologies, taking into account all rights over those resources and to technologies, and by appropriate funding’. A number of provisions, which are more specifically ABS-related, call for participation in research (Article 15 paragraph 6), the sharing of benefits arising from the commercial and other utilization of genetic resources (paragraph 7) and envisage access to and transfer of technology (Article 16) and informationsharing (Article 17). All these claims reflect common terms in international environment agreements and seem well founded and clear.

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The question, however, is how they are related to the general mechanisms as provided for by the Convention. Allocation of genetic resources The most relevant aspect in this regard is the allocation of resources. Indeed, international relations have seen a number of important developments in this regard, which were more or less explicitly aimed at providing for distributional gains for developing countries in the use of natural resources. The deep seabed mining system of the United Nations Convention on the Law of the Sea may be mentioned here, which declared certain parts of the deep seabed and its mineral resources a common heritage of mankind and provided for a number of mechanisms to enable developing countries to participate in deep seabed mining activities and to benefit from its commercial results. The aim of benefiting developing countries was, however, also pursued with quite a different mechanism. The principle of permanent sovereignty over genetic resources means that any state is entitled to the resources situated within its jurisdiction as a matter of territorial sovereignty (Czarnecki 2008: 108ff.). The UN declaration on the permanent sovereignty over natural resources3 and related developments emphasizes that states have the right to regulate the use of their resources and related commercial activities, that they may even form cartels regarding these resources, and that industrialized countries are under a duty to cooperate with developing countries in the exploration, development and exploitation of such resources. It is amazing to see that the same objective of redistribution in favour of developing countries can be achieved by either assigning a sovereign entitlement to a resource or by creating a common good and thus by quite different mechanisms. By and large, the CBD follows the former principle regarding genetic resources although it should be noted that the language used is a bit more cautious. The principle is already highlighted in the preamble to the Convention and, furthermore, made operative by Article 15, paragraph 1. A number of specific clarifications are made in this regard, which take into account the manifold exchanges of genetic resources. In a way, these provisions give preference to those states where the genetic resources have developed their distinct properties. From the justice point of view, this allocation is worth some further reflection. The sovereignty paradigm as just explained is rooted in the idea of the sovereign equality of states. Very broadly, we may understand this principle to signify that in the absence of a more meaningful system of resource allocation, all resources are allocated to states, which enjoy the sovereign right to use them as they deem fit. In addition, but also closely linked, the principle of permanent sovereignty over natural resources is sometimes also seen as flowing from the principle of self-determination of peoples (Schrijver 2008: paragraphs 1, 3 and 7).

ABS, justice, pools and the Nagoya Protocol 307 Thus, sovereignty over resources as a matter of territorial sovereignty is not a very sophisticated mechanism. However, if applied to genetic resources, in effect and by and large, it works in favour of developing countries, which are generally understood to house most of the world’s genetic resources. Nevertheless, it is worth remembering that a number of developed countries are also biodiversity-rich and that there are developing countries which are far from being part of the megadiverse group. In sum, it turns out that the allocation of genetic resources as envisaged by the CBD does not embody a more sophisticated concept of justice, but simply reflects the status quo by making reference to a very old and well established international principle of law (Czarnecki 2008: 196ff.). State exclusionary authority and transboundary situations It has to be noted that, recently, justifying the allocation of genetic resources in a territorial pattern has been questioned. Reference has to be made in this regard to the issue of genetic resources that occur in transboundary situations. This specific situation is nowadays addressed by Article 10 of the Nagoya Protocol. A ‘global multilateral benefit-sharing mechanism’ is envisaged in this regard, as will be explained later.4 Here, it is worth noting that the case of the ‘transboundary genetic resources’ sheds light on the particular characteristics of genetic resources which have an impact on justice. According to the understanding about the uses of genetic resources which prevails in the discussion about ABS, the source genetic material is only needed for making use of the genetic information by means of further reduplication or genetic engineering. From this perspective, the user often needs the genetic material only once in order to extract the genetic information or use it in breeding, or in any other kind of duplication. In most cases, there is thus little need to come back to the provider to get more material or to acquire further material from other sources and countries. Once a user has obtained the material from one source, there is no need for the user to look for other sources. 5 From the provider’s point of view, something like a first come first served principle applies. Where a potential user has obtained material from country A, country B will have no chance of providing the same material to the user and thus will not see any sharing of benefits. In this regard, the case of genetic resources deviates considerably from other resources, to which the principle of sovereignty over natural resources applies. In other cases, such as mineral or biological resources like crude oil, coal or timber, the material is used as such and, therefore, there is a continuing need for supply, which would enable any resource state to get into business. It should finally be noted that a number of principles have evolved in international law, which address the issue of shared resources. Such principles envisage a duty to inform, cooperate and establish joint management (Castillo-Laborde 2008). Such principles could be taken into

308 Peter-Tobias Stoll account in further addressing the issue of genetic resources which occur in transboundary situations. Other concepts of allocation While the application of this principle of sovereignty over natural resources appears to be quite conclusive, it has nevertheless to be remembered that other concepts of allocation have played a significant role in international relations more generally and, in regard to genetic resources, more specifically. The international undertaking for plant genetic resources for food and agriculture had originally declared genetic resources to be a common heritage of mankind, and this idea of a global public good also has some merits if we consider that the important issue about genetic resources is genetic information, and that genetic information – like all information – can be considered a good candidate for a public goods regime. As is well known and explained elsewhere,6 the common heritage approach as developed within FAO for plant genetic resources for food and agriculture has been put into question step by step by the acknowledgement of private intellectual property rights on the one hand and the reciprocal claim for sovereign rights and farmers’ rights on the other. As will be discussed more specifically later on, we can see a renaissance of this idea in the International Treaty for Plant Genetic Resources for Food and Agriculture, which was concluded in 2001 and establishes a multilateral system for certain PGRFAs, which comes close to a public good type regime. Such regimes have the advantage of providing free – or facilitated – access to genetic resources, though they require that the sharing of benefits is organized by other means. ABS transactions The allocation of genetic resources on the basis of territorial sovereignty is the very basis of the system of access and benefit sharing as envisaged by the Convention. It is because of assigning exclusionary rights over genetic resources to particular states and implicitly entitling them to benefit that we need a mechanism to determine access and a specific kind of contractual interrelationship between a provider and a user. The bilateral logic of ABS It is often and widely observed that this mechanism of granting access to genetic resources and concluding agreements from benefit sharing is largely driven by market considerations. Indeed, when acknowledging the exclusionary right of an entity in regard to a certain resource, we would expect this entity to market these resources and to benefit from this. We

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can understand the principle of prior informed consent (PIC) and the principle of mutually agreed terms (MAT) to govern such a relationship. We would expect the idea of reciprocity to govern these relationships. Difficulties with the bilateral approach A number of problems arise from this structure of bilateral ABS transactions. First, the entitlement to genetic resources is quite limited in scope as it is only effective within the jurisdiction of the state of origin. Second, it lacks effectiveness, because the tracking down of genetic material, and to a greater extent control of the resulting genetic information and its use, is difficult. Third, as is less often discussed, negotiations on the terms of an ABS transaction suffer in many cases from an asymmetric distribution of information and resulting inequalities of bargaining power. Fourth, it should be kept in mind that there might be competition between providers, which can furthermore result in less favourable terms of trade. These problems are serious and they may be the main cause of difficulties for the ABS regime. Because of inefficient exclusionary rights, ABS transactions are likely to be risky from the perspective of providers because enforcement is difficult. On the other hand, the inability to control effectively the use of genetic material and genetic information may persuade users to acquire such material or information without any agreement with the provider. But even if the effectiveness of the exclusionary rights could be dramatically improved, the bargaining power of providers, being government entities of developing countries in most cases, will remain critically low. Later on, there will be some competition among providers, which will drive the ‘price’ down. Claims for justice linked to bilateral ABS transactions Having in mind these serious conceptual shortcomings, one is perplexed to see that the aforementioned claims to justice in favour of developing countries all relate to these bilateral transactions as ruled upon by Article 15 et seq. of the Convention. To put it in other words, the CBD seeks to achieve its justice-related objectives by linking these to ‘bilateral’ access and benefit-sharing transactions between providers and users, as has just been explained. However, it is hard to see how these transactions could serve the particular idea of justice inherent in the Convention. It is widely understood that users of genetic resources who act on the basis of a market economy rationale and quid-pro-quo considerations are unlikely to be able to meet these demands. Cooperation However, a closer look at the Convention’s text reveals that these demands are addressed more specifically to the ‘contracting parties’, which clearly

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means the state’s parties to the CBD. As is sometimes highlighted in the text, the model of ABS under the CBD relies on the cooperation of states. In some respects, this cooperation may also involve the Convention’s financial mechanism. This level of interaction could accommodate the various demands outlined above. However, little has been done so far to implement the demands inherent in Articles 15 and 16 of the Convention at the level of intergovernmental cooperation.

Pools and cooperation In the context of the discussion about the CBD’s ABS provisions and their deficiencies, a number of proposals were made to arrange for the use of genetic resources in a way that goes beyond the bilateral pattern of ABS transactions. Those proposals take different forms. Some proposals stick to the bilateral pattern of the ABS system but envisage that different providers ‘pool’ their genetic resources (‘provider pools’). Also, one might think about a closer relationship between providers or users (co-operation between providers and users). Third, a number of proposals are made and examples exist where genetic resources are openly available within a certain system, which will generate and distribute benefits more generally and beyond individual transactions (pools beyond the bilateral logic of the CBD). ‘Provider pools’ Some years ago, the American economist Joseph Vogel proposed that a number or all providing countries should form a cartel and grant access to their genetic resources in a coordinated way (Vogel 1994; Vogel 2007: 115– 136). Vogel’s proposal aimed at excluding competition between provider countries as outlined above. In making his proposal, Vogel alluded to the successful example of a provider cartel in the area of crude oil as has been implemented by OPEC. Apparently, however, this proposal has received only little attention. In contrast to the situation regarding crude oil, coordination among providers in the case of genetic resources would have to be much more sophisticated, and monitoring the members of the cartel and their compliance with the rules might also be difficult. A much less ambitious version of this idea could be envisaged for genetic resources in transboundary situations. Where similar genetic material can be found in neighbouring states, these states could coordinate their access policies accordingly. The idea of a ‘pool’ for genetic resources in transboundary situations could prevent one of the respective provider countries granting access and receiving all the benefits while the other providers receive nothing. From this perspective, such a ‘pool’ might address what is often considered a problem of justice, namely, that only one provider will receive all the benefits.7

ABS, justice, pools and the Nagoya Protocol 311 One could also consider a pooling of genetic resources and traditional knowledge as separate negotiations and agreements on access to these two components and the sharing of benefits severely hamper access and use of genetic resources in a number of cases. Co-operation between providers and users Another way of ‘pooling’ could be closer cooperation between providers and users of genetic resources. Such closer cooperation can indeed be found in certain areas of the exploration and exploitation of resources, chiefly in regard to mineral resources.8 Basically, such cooperation involves a resource state, related agencies, or even enterprises and a foreign industrial partner, and is commonly based on a joint venture. In this kind of cooperation, the industrial partner often takes care of the exploration, exploitation and commercialization of a resource. The returns from commercialization are shared, and often this kind of cooperation envisages a transfer of technology and capacity building. Apparently, these arrangements have evolved in areas where an industrial partner with technological and commercial skills is needed to carry out long-term activities in the territory, and under the control, of a resource state. This scenario differs considerably from the prospecting and use of genetic resources. This might explain why such arrangements have so far neither been proposed nor put into practice in the area of ABS. Likewise, one could consider this model of more intensive cooperation for further development in the academic sphere. Long-standing academic cooperation between universities or research institutions may provide the basis for the confidence needed to establish close cooperation in the utilization of genetic resources. In this area, examples of such cooperation exist, but more general data are not available on the number and structure of such cooperative arrangements. Pools beyond the bilateral logic of the CBD Some other proposals and examples deviate clearly from the ‘bilateral’ logic of the CBD’s ABS provisions and envisage a kind of ‘pool’ of genetic resources which is freely accessible for certain authorized users. The ‘multilateral system’ under the International Treaty for Plant Genetic Resources for Food and Agriculture (ITPGRFA) is built on such an idea. A similar structure is sometimes applied in industry in the form of ‘patent pools’ (Merges 2001: 123ff.). In this case, a number of companies pool their patents for free use by each of the partners. The similarity between these apparently quite different structures lies in the fact that, at least theoretically, the members of such a ‘pool’ can be considered providers and users at the same time. However, such pools can only be

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established among partners that contribute equally. It is difficult to see this being the case with ABS. The potential of the Nagoya Protocol for ‘pool’ solutions Most of the forms of pooling or cooperation as discussed above could already have been implemented under the existing provisions of the CBD. However, the Nagoya Protocol may be considered to further encourage or facilitate the establishment of such solutions. Article 11, which envisages ‘transboundary cooperation’ has to be mentioned here. It calls for cooperation between parties when genetic resources are found in situ within the territory of more than one party. However, the provision does not go far beyond calling for cooperation and, in particular, does not specify the aims of such cooperation. Another relevant provision is Article 10, which envisages a ‘global multilateral benefit-sharing mechanism’. The provision particularly addresses situations where genetic resources and traditional knowledge occur in transboundary situations. Furthermore, the provision points to situations in which it is not possible to grant or obtain prior informed consent. For these situations the provision envisages the establishment of a global multilateral benefit-sharing mechanism. The whole provision is very cautiously drafted, as it does not directly call for such a mechanism to be developed but only requires parties to consider the need for and modalities of such a mechanism. Article 10 envisages a sharing of benefits in the particular cases mentioned in the provision. However, the benefits are not channelled to a specific provider but will possibly be distributed by this mechanism with the aim of supporting the conservation of biological diversity and the sustainable use of its components globally. Obviously this mechanism would have to be equipped with the authority to agree with and to collect the benefits from potential users and to distribute these benefits according to the objectives on the basis of a policy which has to be established. When considering that ecosystems and flora and fauna are spread around regions without consideration of man-made frontiers, this new ‘multilateral benefit-sharing mechanism’ might become quite relevant. The crucial point of Article 10 is that it does not address access. Any implementation of the provision therefore requires addressing three questions. First, the kind of resources the mechanism will apply to and how this will be determined have to be clarified. Second, provider states would probably like to know whether they will still be able to determine access in regard to such resources. Third, potential users will probably need to know how to contribute to the mechanism, and who will grant what kind of access.

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Conclusion The ABS system as defined by the CBD is burdened with high expectations and a high-flying sense of justice. At the same time, it builds on bilateral relationships that have a number of shortcomings. Even if these were fixed, doubts remain as to the ability of bilateral relationships to meet many of these expectations and standards. Intuitively, some sort of cooperation or resource pooling appears to be helpful in this situation. However, in reality, it does not take place very often. In addition, some of the more promising options at hand go beyond the bilateral logic of the CBD and thereby put the whole system into question. This, in a way, is also true for the multilateral benefit-sharing mechanism as envisaged by Article 10 of the Nagoya Protocol. Rather than offering a clear solution, the provision can be understood as a starting point for a new round of discussion and negotiation on how to allocate the world’s genetic resources and to arrange for a just and equitable sharing of benefits.

Notes 1 Reference to general definition of pools in the book. 2 For details see the section below headed ‘Difficulties with the bilateral approach’. 3 Permanent Sovereignty over Natural Resources, G.A. res. 1803 (XVII), A/5217 (1962); see Schrijver, NJ (2008) ‘Natural resources, permanent sovereignty’, in Wolfrum, R (ed.), The Max Planck encyclopedia of public international law, Oxford University Press. Online edition available at http://www.mpepil.com; Hossain, K and Chowdhury, R (eds) (1984) Permanent sovereignty over natural resources in international law: principle and practice, St Martin’s Press, New York. 4 See below, ‘The potential of the Nagoya Protocol for “pool” solutions’. 5 See Winter, G (2009) ‘Towards regional common pools of GRs – improving the effectiveness and justice of ABS’, in Kamau, EC and Winter, G (eds), Genetic resources, traditional knowledge and the law. Solutions for access and benefit sharing, Earthscan, London, pp. 19–35 at 25ff. 6 See Stoll, P-T (2009) ‘Access to GR and benefit-sharing – underlying concepts and the idea of justice’, in Kamau, EC and Winter, G (eds), Genetic resources, traditional knowledge and the law. Solutions for access and benefit sharing, Earthscan, London, pp. 3–18 at 6ff. 7 See above under ‘State exclusionary authority and transboundary situations’; Winter, G (2009) ‘Towards regional common pools of GRs – improving the effectiveness and justice of ABS’, in Kamau, EC and Winter, G (eds), Genetic resources, traditional knowledge and the law. Solutions for access and benefit sharing, Earthscan, London, pp. 19–35 at 25ff. 8 See Kirchner, C. et al. (1979) Mining ventures in developing countries, Deventer; Meyer, A (1989) Vertragsformen und Besteuerung im Rohstoffsektor: eine ökonomische Analyse, Konstanz.

Bibliography Czarnecki, R (2008) Verteilungsgerechtigkeit im Umweltvölkerrecht: Dogmatik und Umsetzung, Schriften zum Umweltrecht Bd. 159, Duncker and Humbolt, Berlin.

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de Jonge, B and Louwaars, N (2009) ‘The diversity of principles underlying the concept of benefit sharing’, in Kamau, EC and Winter, G (eds), Genetic resources, traditional knowledge and the law. Solutions for access and benefit sharing, Earthscan, London, pp. 37–56. del Castillo-Laborde, L (2008) ‘Equitable utilization of shared resources’, in Wolfrum, R (ed.), The Max Planck Encyclopedia of Public International Law, Oxford University Press. Online edition available at http://www.mpepil.com, viewed 18 January 2013. Kirchner, C, Schanze, E, Schlabrandorff, FG and Mahoney, WJ (1979) Mining ventures in developing countries. Part I, interests, bargaining process, legal concepts, Kluwer, Deventer. Merges, RP (2001) ‘Institutions for intellectual property transactions: the case of patent pools’, in Dreyfuss, RC, Zimmerman, DL and First, H (eds), Expanding the boundaries of intellectual property: innovation policy for the knowledge society, Oxford University Press, New York, pp. 123–166. Meyer, A (1990) Vertragsformen und Besteuerung im Rohstoffsektor: eine ökonomische Analyse, Hartung-Gorre, Konstanz. Permanent sovereignty over natural resources, G.A. Res. 1803 (XVII), A/5217. Peters, P, Schrijver, NJ and Waart, PJIM de (1984) ‘Permanent sovereignty, foreign investment and state practice’, in Hossain, K and Chowdhury, SR (eds), Permanent sovereignty over natural resources in international law: principle and practice, St. Martin’s Press, New York, pp. 88–143. Schrijver, NJ (2008) ‘Natural resources, permanent sovereignty’, in Wolfrum, R (ed.), The Max Planck Encyclopedia of Public International Law, Oxford University Press. Online edition available at http://www.mpepil.com, viewed 18 January 2013. Stoll, P-T (2009) ‘Access to GRs and benefit sharing: underlying concepts and the idea of justice’, in Kamau, EC and Winter, G (eds), Genetic resources, traditional knowledge and the law. Solutions for access and benefit sharing, Earthscan, London, pp. 3–18. Vogel, JH (1994) Genes for sale, Oxford University Press, New York. Vogel, JH (2007) ‘From the “tragedy of the commons” to the “tragedy of the commonplace”: analysis and synthesis through the lens of economic theory’, in McManis, CR (ed.), Biodiversity and the law: intellectual property, biotechnology and traditional knowledge, Earthscan, London, pp. 115–136. Winter, G (2009) ‘Towards regional common pools for GRs – improving the effectiveness and justice of ABS’, in Kamau, EC and Winter, G (eds), Genetic resources, traditional knowledge and the Law. Solutions for access and benefit sharing, Earthscan, London, pp. 19–35.

16 The World Health Organization’s Pandemic Influenza Preparedness Framework as a public health resources pool Marie Wilke1 Introduction Natural resource management often requires a cooperative approach to ensure sustainable and equitable usage. This is particularly true for resources that are traded at the multilateral level and where the relationship between resource providers and users is characterized by interdependency and power asymmetries. The area of influenza pandemic response exemplifies this dynamic. The development of vaccines and other medical treatment critically depends on access to the original virus, not only for research, but more importantly, as direct input for vaccines in the form of dead organisms. As a consequence, private actors depend on access to publicly held virus samples, while governments depend on the results of research and development in the form of pharmaceuticals. In addition, while most research and development is conducted in Europe and North America, viruses with pandemic potential most commonly emerge in developing nations. Thus, the exchange of biological samples and epidemiological information needs to cross borders and continents for the development of vaccines and for global pandemic prevention and response. This dual interdependency can best be managed through a joint exchange system. In 2007, in response to the lasting avian flu crisis, member states of the World Health Organization (WHO) entered into negotiations to establish such a mechanism while building upon existing structures. The resulting ‘Pandemic Influenza Preparedness Framework for the Sharing of Influenza Viruses and Access to Vaccines and Other Benefits’ (WHO 2011b [PIP Framework]) that was adopted by the World Health Assembly (WHA) in May 2011 aims to secure an efficient exchange of biological materials and epidemiological information, and access to vaccines and medical treatment to ensure efficient global pandemic response. To some extent, the system is designed in the form of a common resources pool as stakeholders submit different resources, including biological samples,

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epidemiological information, and vaccines and medical treatment, for the free access and use of others. For this book, two interesting questions arise in this context: first, is the new system able to regulate mutual exchange in an effective and equitable manner? Second, what can be learned from this system for other resource pools, in particular in the area of access to genetic resources and the fair and equitable sharing of benefits deriving from their utilization (access and benefit sharing (ABS))? The chapter will first discuss the political economy of global pandemic response, including lessons from the H5N1 avian flu crisis; second, introduce the main elements of the PIP Framework; and third, assess the system in the light of the two questions raised above. The assessment will focus on the system’s effectiveness regarding the exchange of resources – using the contribution to global pandemic response as a benchmark – and equitability regarding benefit sharing – using the contribution to ensuring global access to needed vaccines as a benchmark. The chapter will conclude by discussing lessons for the PIP Framework itself, for other ABS systems in the health area, and for common pools more generally.

The political economy of global pandemic influenza response Fifty to one hundred million people died of the Spanish flu between 1918 and 1920, making it the most deadly pandemic in modern times. In the 1950s and 1960s, the world experienced two more pandemics, each causing more than one million deaths (Paul 2003: 1132, 1273). After that, 40 years passed before a new pandemic emerged in 2009.2 However, the H1N1 swine flu pandemic lasting from 2009 to 2011 proved less fatal than previous pandemics (WHO 2009b PIP Guidance). On the other hand, the spread of the highly pathogenic avian influenza of sub-type H5N1, 3 which began in 2005, has not caused a pandemic but has proven much more aggressive than H1N1. The particular clade or category known to have caused most human infections since 2005 – the so-called Asian lineage subclade 2 – was first discovered in Indonesian poultry in 2003.4 The first human infections were reported in 2005 by Indonesia from where the virus spread to, amongst others, China, Turkey and Egypt. By the end of 2007 more than one hundred people in Indonesia were infected with the virus, showing a fatality rate of over 80 per cent. As of February 2012, 586 people in 15 countries are known to have been infected, with 346 casualities.5 During the H5N1 avian flu crisis, states shared samples of potentially pandemic H5N1 strains through the WHO’s Global Influenza Surveillance Network (GISN). For more than 60 years, countries have used the GISN to coordinate their surveillance efforts for seasonal influenza epidemics. Under the GISN, national influenza centres (NICs) would submit national virus samples collected in hospitals, clinics and other laboratories to WHO

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collaborating centres (WHO CCs) for monitoring and research purposes. These collaborating centres, situated in Australia, China, Japan, the United Kingdom and the United States, would use the samples for monitoring purposes and to develop diagnostic kits for the NICs and to identify candidate vaccine viruses (viruses that could be suitable for the development of vaccines as they represent a predominant strain). The CCs would further provide the WHO with relevant epidemiological information, which could then be accessed through the WHO by all other GISN laboratories (NICs and WHO laboratories). The GISN was thus a network of national and WHO laboratories that cooperated to monitor the spread of seasonal influenza and to develop appropriate responses. Where relevant, the GISN system would also be used for monitoring influenza viruses with pandemic potential, though the primary objective was the coordination of responses to seasonal influenzas. During the H5N1 crisis, Indonesian samples shared through the GISN were essential for the identification, assessment and monitoring of the virus as well as for the development of diagnostic kits. However, after learning about an Australian company applying for a patent on a vaccine developed on the basis of the Indonesian specimens, the Indonesian authorities refused to continue sharing samples (Sedyaningsih et al. 2008: 486). Indonesia argued that it had never consented to the sharing of samples with private companies or the commercial application of the sample or its derivatives and that the process, now limiting Indonesia’s access to said vaccines, was in violation of international law. Indonesia specifically referred to the principle of sovereignty over genetic resources as enshrined in the Convention on Biological Diversity (CBD) (Gerhardsen 2007). Indonesia also argued that the unauthorized onward transfer to institutions outside the GISN had violated internal WHO GISN procedures (Sedyaningsih et al. 2008: 485–486). However, relevant binding WHO agreements were silent on limitations as to the usage of shared virus samples or the rights of private actors outside the system. Only nonbinding guidelines developed by the WHO in 2005 recognized the rights of providing countries, noting that these should be consulted prior to onward transfer of samples (Khor and Sashikant 2007; Sedyaningsih et al. 2008: 486).6 In reality, however, it was common practice to share developed vaccine strains on the basis of material transfer agreements negotiated between the WHO or respective CCs and the recipient without the involvement of the providing country (Khor and Sashikant 2007). In the relevant case, Indonesia had not insisted on signing a material transfer agreement (MTA) with the WHO with the aim of reducing bureaucratic burden and facilitating global action against the virus. Instead, according to Indonesian statements, the officials trusted that the GISN institutions would follow the guidelines usually set out in MTAs regarding the rights and obligations of recipients, even in instances where Indonesia had not concluded an MTA (Khor 2007).

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The situation was particularly critical as Indonesia – the country with the highest infection and fatality rates – could not purchase the developed vaccines and medication due to high market prices, insufficient global production and a lack of domestic production capacity. When the first human H5N1 infections were reported in early 2005, the annual global vaccine production capacity was estimated to be 350 million doses. This stood in stark contrast to the estimated 13.4 billion doses needed to immunize the entire world population (Collin et al. 2009: 5184–5186).7 Moreover, 90 per cent of influenza vaccine production was located in only nine countries (mainly in Western Europe and North America) with the countries where these companies are situated having placed a large number of advanced-purchase agreements guaranteeing priority treatment in case of emergency (Kieny et al. 2006; Collin et al. 2009: 5185). In addition, only three companies were responsible for the vast majority of this production. Resulting high prices and strong competition for the limited resources barred Indonesia and other developing countries from purchasing needed treatments. The case exemplifies developing countries’ dilemma. While they are dependent on and keen to support global efforts to combat pandemics by sharing needed virus strains, they previously found themselves excluded from the benefits of that process. Likewise, Indonesia’s story is telling for the interdependency of industry and governments. It was with these lessons in mind that WHO member states entered into the negotiations that led to the 2011 PIP Framework.

An introduction to the PIP Framework Adopted in the form of a resolution during the 64th World Health Assembly (WHA), the PIP Framework is a non-binding document that aims at guiding global cooperation on pandemic response efforts.8 It is based on the premise that states have a ‘commitment to share [...] influenza viruses [...] and the benefits, considering these equally important parts of the collective action for global public health’ (PIP Framework: Article 1.3) further noting that latter should be shared with all WHO member states ‘based on public health risk and need’ (PIP Framework: Article 1.8). Despite its non-binding character, the agreement notes that states ‘should in a rapid, systematic and timely manner provide [materials], as feasible’. It further reaffirms ‘countries’ sovereign rights over their biological resources’ (PIP Framework: Article 1.10) and ‘WHO parties’ obligations under the International Health Regulations of 2005’9 (PIP Framework: Article 1.6). The main purpose of the PIP Framework is the establishment of a standing mechanism for exchanging viral samples, relevant epidemiological information and resulting benefits, first and foremost, vaccines (PIP Framework: Articles 1.3 and 1.15). For that purpose the

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Framework builds upon the previous GISN – now called Global Influenza Surveillance and Response System (GISRS) – by maintaining the structure but clarifying the rights and obligations of the different public and private actors involved, and by adding new benefit- sharing obligations and a relevant mechanism for distribution. In practice the GISRS functions similarly to the previous GISN. That is, materials are shared through the GISRS with the NICs providing the original samples to CCs and other WHO laboratories. In return, the CCs share diagnostic reagents, candidate vaccines viruses and test kits with the NICs. The diagnostic reagents and candidate vaccine viruses are also available to non-GISRS institutions, that is, all interested laboratories and other institutions, whether commercial or for non-commercial research, that are not formally part of the GISRS (i.e. that are not NICs, CCs or other WHO laboratories). The novelty, compared to the old GISN, is the benefit-sharing obligations, in particular those for non-GISRS institutions. These institutions are now requested to share the actual benefits of commercial research – be they in the form of vaccines, medical treatment, relevant production licences or similar means – on the basis of material transfer agreements concluded among the WHO and the relevant non-GISRS institution. In practice, this means that non-GISRS institutions make benefits available to the WHO, which then manages the distribution of the received benefits. As with the resources (the virus samples, diagnostic reagents, candidate vaccine viruses, etc.), the benefits are not shared with countries on a bilateral basis but with the WHO membership as a whole. A summary of the GISRS’ functioning is provided in Figure 16.1. These new benefit-sharing obligations require the involvement of actors not previously (directly) engaged in the GISN. First, the WHO Director General is involved to the extent that s/he negotiates the MTAs with nonGISRS institutions. Also, s/he oversees the distribution of received benefits. Second, a PIP Framework Advisory Group was established to monitor the implementation of the PIP Framework, to assess the Framework’s functioning and to provide related assessments and recommendations. The Advisory Group consists of 18 experts, such as policy makers, public health experts, and technical influenza experts from three countries of each WHO region. Third, the PIP Framework is linked to other WHO instruments and bodies such as the Global Pandemic Influenza Action Plan to Increase Vaccine Supply (Global Action Plan (GAP), WHO 2006) and the Strategic Advisory Group of Experts on Immunization (SAGE). The main aim of these links is to ensure that the PIP Framework harmonizes with other WHO initiatives that work towards the same goal, i.e. increasing pandemic influenza preparedness and access to relevant vaccines and medical treatment. In this context, a number of complementary mechanisms foreseen by the PIP Framework should be mentioned, first and foremost the

320 Marie Wilke H5N1  vaccine stockpile (PIP Framework: Article 6.8). This proposal integrates a SAGE recommendation issued in 2007 under the GAP, according to which, an H5N1 stockpile of 150 million doses was needed (WHO SAGE 2007). According to both the SAGE recommendation and the PIP Framework, the stockpile is meant initially to include 150 million doses of H5N1 vaccine, 50 million of which would be for use in affected countries while the other 100 million would be released only in times of pandemic. At this stage, three manufacturers have donated (though only in virtual form) a total of 210 million doses (WHO 2009b PIP Guidance). At the moment, the stockpile is limited to H5N1 vaccines, as experience during the H1N1 pandemic showed that an H1N1 stockpile was not feasible due to the fast mutation of the virus strain. In either case, participation is voluntary. The Director General is expected to work with experts, including SAGE and the Advisory Group, to further develop the stockpile. The legally binding nature of the Framework and its SMTAs As mentioned above, the Framework takes the form of a WHA resolution. The Framework is thus inter-governmental in nature, taking the form of a mere declaration and not an international treaty. This is reflected in a number of provisions, in particular those in chapter six on governmental cooperation to increase global vaccine access. Provisions on technology transfer or tiered pricing are mere best-endeavour clauses, calling upon countries to endorse their industries to take appropriate actions. But they do not bind the pharmaceutical industry or even governments. Importantly, however, all actors that participate in the GISRS, whether governmental or non-governmental, are automatically bound by the PIP Framework rules governing the rights and obligations of material suppliers and recipients. This is achieved through two standard material transfer agreements (SMTAs), SMTA1 and SMTA2, contained in the annexes of the PIP Framework. These SMTAs can be understood as ‘contract clauses’ that apply automatically the moment an actor participates in the GISRS. This includes GISRS actors, meaning all WHO member states, national laboratories and WHO-recognized laboratories (including but not limited to the above mentioned Collaborating Centres), and non-GISRS institutions such as private pharmaceutical companies or university research institutions. The SMTAs govern the rights and obligations of these actors as they relate to their participation in the exchange system, including their material usage rights and benefit-sharing obligations. While SMTA1 applies among GISRS institutions (that is the NICs, WHO and WHO laboratories) (PIP Framework: Annex 1), SMTA2 applies between the WHO and non-GISRS institutions (Annex 2). Thus, the latter governs the transfer of material from WHO laboratories to private companies or other non-GISRS institutions, setting out the usage rights

The WHO PIP Framework as a pool 321 and benefit-sharing obligations of the receiving company. The activities of WHO laboratories are further governed by terms of reference (ToRs) agreed to by the laboratories and the WHO. Relevant standard ToRs are contained in the PIP Framework (PIP Framework: Annex 5), the development of which is informed by guiding principles contained in the Framework’s Annex 4. No ToRs, however, exist for non-GISRS institutions as these are not part of the GISRS and their engagement with the system (normally as recipient) can be ad hoc and incidental. The SMTA2 is meant to fulfil this role instead. Unlike SMTA1, which does not require signature, SMTA2 needs to be signed by the WHO Director General and the non-GISRS recipient prior to the transfer. Furthermore, a total of ten provisions in SMTA2 are not predefined but need to be agreed by the parties (the WHO and the recipient). These include, amongst others, provisions on the obligations of the provider, liability and indemnity, duration and termination of the agreement, governing law and most importantly, the benefit-sharing obligations of the recipients (PIP Framework: Annex 2). The recipient needs to choose two out of four different benefit-sharing obligations, the scope of which needs to be negotiated by the parties (PIP Framework: Annex 2, Article 4.A). The selection will be informed by the nature and capacities of the recipient (PIP Framework: Article 1, footnote 1). Consequently, case specific negotiations on benefit-sharing obligations continue to be critical. In addition to the SMTA2 benefit-sharing obligations, vaccine, diagnostic and pharmaceutical manufacturers using the WHO GISRS are under an obligation to contribute 50 per cent of the running costs of the WHO GISRS as an ‘annual partnership contribution’ (PIP Framework: Article 6.14.3). In 2012, this amounted to approximately USD 56.6 million. The specific amount for each company, as well as the mechanism for contribution, is to be defined by the Director General and the Advisory Group. This is the only PIP Framework provision beyond the SMTA2 that includes a concrete obligation for non-GISRS institutions. The WHO, under the supervision of the Director General, administers this financing process. In 2012 discussions were undertaken to define a payment methodology detailing who would have to pay how much. While the talks have not yet resulted in final agreement, in early 2013 industry proposed to commence with payments nonetheless and to define the final methodology at a later stage (New 2013). Importantly, SMTA1 and 2 state that ‘the recipient shall only further transfer the PIP biological material if the prospective recipient has concluded an SMTA with the WHO. Any further transfer shall be reported to the WHO’ (PIP Framework: Annex 2, 4.4). For GISRS laboratories, any breach of the relevant SMTAs or ToRs may be sanctioned with the suspension or revocation of the laboratory’s WHO designation, if determined appropriate by the Director General (PIP Framework: Article

322 Marie Wilke 7.3.4). These mechanisms mean to pre-empt situations where GISRS institutions engage in unauthorized transfer to non-GISRS institutions (i.e. transfer without having signed an SMTA2) in order to prevent situations where the unauthorized utilization cannot be sanctioned. Further, it should be noted that any onward transfer that meets the requirements of SMTA1 and SMTA2 may occur without consulting with the NIC and/or member states that originally submitted the material to the system. According to the Framework and SMTA1, countries automatically agree to any onward transfer when submitting resources to the system (PIP Framework: Annex 1, Article 4.3).

• requires negotiation on basis of SMTA2 – among WHO and non-GISRS actors – must be concluded before transfer • allows for IRPS • requires annual contribution and benefit sharing alternatives (donator reserves products, grant free/affordable, donate/ reserve diagnostic kits, capacity buidling or technology transfer) National Influenza Centres

Diagnostics reagents, test kist, candidate vaccine virueses SMTA2

Virus samples (PIP biological material) collected by national laboratories

Collaborating Centres, other GISRS laboratories

Samples, diagnostic reagents, candidate vaccine viruses

SMTA1 Benefit sharing, e.g. in-kind, financial, technology transfer etc.

National Influenza Centres

• among the providing and receiving GISRS laboratories – Further informed by ToRs neither provider nor recipient may seek IPRS on material • no benefit sharing but collaboration and acknowledgement

Figure 16.1 The functioning of the GISRS and the two SMTAs

The WHO PIP Framework as a pool 323 In conclusion, it can be noted that while the Framework itself is not binding upon WHO member states, it does set out legally binding ‘contract clauses’ that govern the participation in the GISRS for all public and private laboratories. In most cases, these apply automatically while in the case of non-GISRS institutions, SMTA2s must be signed prior to material transfer. Importantly, this also means that all actors have agreements with the WHO but not with each other. This also applies to the benefit-sharing obligations, which are negotiated and implemented between the user and the WHO. Countries then have a right to benefits vis-á-vis the WHO. The scope of benefits It should be mentioned that the benefits identified in the framework extend beyond access to pharmaceuticals. Article 6 of the Framework agreement classifies the following activities and services as benefits: a. b. c. d. e. f. g. h. i. j. k. l. m.

pandemic risk assessment and response; provision of PIP candidate vaccine viruses; provision of diagnostic reagents and test kits; provision of reference agents for potency determination of vaccines; laboratory and influenza surveillance capacity building; regulatory capacity building; antiviral stockpiles; pandemic influenza preparedness vaccine stockpile; access to vaccines in inter-pandemic period for developing countries; access to pandemic influenza vaccines; tiered pricing; technology transfer; and sustainable and innovative financing.

Services provided by the WHO or the GISRS laboratories are thus also considered benefits. Many of these services had been available before the adoption of the PIP Framework, but their provision has improved through the new agreement. Benefits from non-GISRS institutions in the form of pharmaceuticals, on the other hand, are new and can, for the purpose of this chapter, be considered the most relevant benefit-sharing obligations. In the following, the chapter will refer to biological samples, antigens and genetic reagents, candidate vaccine viruses, diagnostic kits and epidemiological information as ‘resources’. The term ‘benefits’, on the other hand, will be used to identify the tangibles from non-GISRS institutions, that is, vaccines, medical treatments, relevant licences and private capacity building. Depending on whether the recipient manufactures vaccines, antivirals or other PIP-relevant products, SMTA2 provides for different alternatives. For vaccine and/or antiviral treatment manufacturers, the agreement foresees the following four options of which the recipient needs to commit to at least two:

324 Marie Wilke • •

•

•

Donate at least 10 per cent of real time pandemic vaccine production/X treatment courses of needed antiviral medicine for the pandemic to WHO. Reserve at least 10 per cent of real time pandemic vaccine production/X treatment courses of needed antiviral medicine for the pandemic at affordable prices [to WHO]. Grant to manufacturers in developing countries licences on mutually agreed terms that should be fair and reasonable including in respect of affordable royalties, taking into account development levels in the country of end use of the products, on technology, know-how, products and processes for which it holds IPR for the production of (i) influenza vaccines, (ii) adjuvants, (iii) antivirals and/or (iv) diagnostics. Grant royalty-free licences to manufacturers in developing countries or grant to WHO royalty-free, non-exclusive licences on IPR, which can be sublicensed, for the production of pandemic influenza vaccines, adjuvants, antivirals products and diagnostics needed in a pandemic. WHO may sublicense these licences to manufacturers in developing countries on appropriate terms and conditions, and in accordance with sound public health principles (emphasis added).

For producers of other products, the agreement provides for the following additional options: • • • •

Donate to the WHO at least X diagnostic kits needed for pandemics. Reserve for the WHO at least X diagnostic kits needed for pandemics, at affordable prices. Support, in coordination with the WHO, the strengthening of influenzaspecific laboratory and surveillance capacity in developing countries. Support, in coordination with the WHO, transfer of technology, know-how and/or processes for pandemic influenza preparedness and response in developing countries (emphasis added).

Thus, manufacturers may choose either to donate and/or reserve their products and/or to grant licences for free/on fair mutually agreed terms. Where the products are not vaccines or antiviral treatments, manufacturers may also choose to engage in capacity building or technology-transfer efforts instead. As said, these benefits stand next to the permanent but voluntary H5N1 stockpile established by the Director General and the obligation for companies to jointly finance 50 per cent of the running costs of the GISRS. The scope of biological materials Finally, regarding the substantive scope of the Framework, it should be mentioned that this is limited to ‘H5N1 and other influenza viruses with human pathogenic potential’ (PIP Framework: Article 3.1). The scope

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does not extend to seasonal influenza and non-influenza pathogens. The term ‘influenza viruses with pathogenic potential’ is further defined in provisions on use of terms. Accordingly, they are ‘wild-type influenza viruses that have been found to infect humans’ and that are distinct from seasonal viruses10 (PIP Framework: Article 4.2). The agreement further defines the term ‘biological sample’ (or PIP biological material) to include human clinical specimens, virus isolates […] and modified viruses prepared from […] influenza viruses with human pandemic potential developed by WHO GISRS laboratories11 (PIP Framework: Article 4.1). Also included are ‘extracted ribonucleic acid (RNA) […] and complementary deoxyribonucleic acid (cDNA) that encompass the entire coding region of one or more viral genes’ (PIP Framework: Article 4.1). Importantly, biological substances that may be contained in clinical specimens (for instance blood, serum or plasma taken from humans or animals) shared under the Framework, are excluded from the agreement’s scope (PIP Framework: Article 4.2). This exclusion ensures that countries have absolute certainty about the type of information they share when submitting a specimen. By limiting the scope to influenza viruses with pathogenic potential, any other valuable genetic information contained in a blood sample for instance, even if ‘accidentally’ transmitted, will not be covered by the agreement.

The PIP Framework as a common pool Common pools as a conceptual framework The PIP system functions more as a pool of resources than a bilateral exchange system. Common pools have been characterized as an alternative resource management approach to privatization and governmental regulation (Ostrom 1990). To outsiders, common pools appear as private property with limited access while to insiders they usually appear as open access. The main objective of a common pool is just resource management for the benefit of all (Ostrom 1990). Common management is thus concerned with sustainability, efficiency and equity. Common-pool resource systems are traditionally used for ecosystem management such as rivers and pastoral land. Joint management by the principals can prevent overuse and degeneration caused by either principals acting in their own short-term interest or no one assuming responsibility (Ostrom 1990). Nowadays, pool systems are also increasingly used in the area of knowledge. The exchange of ideas through databases aims at preventing misuse and unnecessary restrictions that constrain the sustainable use of knowledge for further research and development (Hess and Ostrom 2007). Pool systems are also known in the area of public health. The Pool for Open Innovation against Neglected Tropical Diseases 12 where pharmaceutical firms, biotech companies and academic institutions

326 Marie Wilke share knowledge, and the Medicines Patent Pool13 which negotiates with patent holders to share their intellectual property with the pool to license it to other producers are two examples. In most of these traditional common pools, resources – whether owned commonly or privately – are deposited in a pool to which a number of principals have access. Good examples are the Medicines Patent Pool or publicly owned ecosystems. Here, owners provide resources for common use by others. In other cases, for instance in the case of academic databases, the principals are also the owners of the resources and the objective of the pool is to exchange resources for common use. The PIP Framework system, on the other hand, is characterized by two rather distinct circumstances. First, the exchange does not concern a homogeneous group of resources. On the contrary, the pool extends to the original biological samples, the diagnostic antigens, the epidemiological information, the candidate vaccine viruses, the vaccine production knowledge and the actual medical treatments and vaccines. Second, the principals are of diverse nature and their relationship is defined by power asymmetries. In addition to the previously described relationship of developing and developed countries, the positions of established and new pharmaceutical companies, private and public laboratories and the WHO institutions, shape the system’s functioning. This interplay results in a highly complex system that cannot be easily compared with classic common pools. The system further distinguishes itself from the classic concept of common pools, as it is not concerned with the conservation of resources (be they natural resources or knowledge). On the contrary, the clinical samples are shared with the aim of developing vaccines on the basis of the genetically encoded information in order to make the virus extinct. Moreover, the system does not follow the model of a knowledge pool (Hess and Ostrom 2007). The sharing of samples is, indeed, primarily concerned with information (genetically encoded information and epidemiological information), as is the return of diagnostic reagents and antigens, knowledge transfer and vaccine sharing. However, this exchange does not concern knowledge, information or data as in the case of databases or open access libraries (Hess and Ostrom 2007: 7–8). Rather, most information comes with a physical resource, be it the natural resource, the diagnostic kits or the medical treatment. Nonetheless the PIP system shares the main characteristics of a common pool. It is a system regulating pooled resources that are available for those inside the system but are restricted for outsiders. It follows that the concept of common pools constitutes an appropriate conceptual framework for analysis vis-à-vis the PIP Framework. Hence, the following section will assess the PIP Framework as a common pool and its potential to regulate the identified exchanges in an effective and equitable manner – two expressions of sustainability.

The WHO PIP Framework as a pool 327 Assessment of the PIP Framework The following is a two-set assessment of the effectiveness and fairness of the PIP Framework. The assessment starts off by analysing the effectiveness of the procedures that govern the exchange of resources and those that govern the exchange of benefits. The standard for effectiveness is the system’s contribution to pandemic influenza response. In a second step, it then looks at whether the benefit sharing is equitable. The benchmark here is the system’s contribution to ensuring access to vaccines and other treatment and thereby reducing the vulnerability of poor countries. Effectiveness of responding to pandemic influenza EFFECTIVE EXCHANGE OF RESOURCES

The research community has often expressed concerns regarding imposed exchange requirements or systems for biological samples, assuming that these would destroy customary practices, thereby reducing the effectiveness of global research collaboration. Similar fears were articulated when the WHO launched the PIP negotiations in 2007 (New 2007; Mara 2008). However, as the above discussion has shown, the PIP Framework has refrained from imposing a new system. Instead it largely builds upon the GISN/GISRS structure without modifying the actual exchange routes and practices. The obvious advantage is that involved laboratories can continue to use the structures they are familiar with, without having to reform their external operations. In the past, the GISN has proven itself to be a highly efficient and effective system for sharing resources and advancing global research on influenza response. Currently, there are 136 national influenza centres (NICs) in 106 states that regularly share samples with six collaborating centres (CCs) (WHO [GISRS]). In addition there are four essentially regulatory laboratories (ERL), and 12 specialized H5 reference laboratories that fulfil similar, yet more specialized functions than the CCs (WHO [GISRS]). In 2010, more than one million specimens were shared among these laboratories with more than 140 GISRS shipments taking place, making it the prime route for specimen exchange (WHO [GISRS]). While it is unlikely that the PIP Framework will limit the success of the system with laboratories relying on bilateral exchange systems, at the time of writing there is no data available to verify this assumption. The effectiveness of the system is further increased through logistical support in the form of guidance on and assistance with the transportation of shipments and provision of reagents and laboratory supply, including on the safe handling of samples. The WHO Shipping Fund Project is a key aspect of logistical support as it provides assistance for safe and fast shipping and covers the costs of shipping PIP specimens from the NICs to

328 Marie Wilke WHO laboratories.14 Logistical support also includes activities on urgent shipments in times of emergency and on long-term capacity building to further increase the effectiveness and safety of the system (WHO ‘Logistic activities’). Equally important is the newly established Influenza Virus Traceability Mechanism (IVTM), a web-based monitoring mechanism that records the movement of PIP biological materials to, within and through the GISRS, including to institutions outside the system (PIP Framework: Article 4.4). Importantly, the IVTM also details information on the results of material analysis, which increases the effectiveness of information sharing and research collaboration while ensuring that providing laboratories are informed about the onward transfer of their samples and the outcome of relevant testing series. In that regard, it differs from the FluNet mechanism which provides information on epidemiological information generated through the GISRS, such as the number of influenza viruses detected by sub-type at a given point and place.15 The additional IVTM required information will certainly increase the burden of laboratories (WHO and non-GISRS laboratories) which were previously not under an obligation to notify shipments or to prepare summaries of their testing results for other laboratories. Nonetheless, the benefits clearly seem to outweigh the additional burden, in particular as safe research already requires detailed reporting of activities. In addition, in order to ensure that the IVTM-required information does not hinder the functioning of the GISRS in times of emergency, the WHO Director General may temporarily modify the requirement to record all PIP biological materials, provided that this only affects strains relevant for the emergency response (PIP Framework: Article 5.3.3). Importantly, all GISRS laboratories have a right to receive the samples, relevant information, and antigenic and genetic products developed on the basis of GISRS specimens (PIP Framework: Article 5.2). One aspect that has been criticized as severely diminishing the effectiveness of the exchange system, however, is the non-automatic nature of the standard agreement regulating the onward transfer to non-GISRS institutions (SMTA2). Indeed the negotiation can hamper both the speed at which an agreement is signed and the quality of the agreement. In fact, during the 2012 World Health Assembly member states and civil society were harshly critical that no SMTA2 had up to then been signed, despite transfers taking place (WHO 2012b [Report of the Advisory Group]). The first agreement was finally concluded in early 2013 with the WHO announcing the signing of an SMTA2 with GlaxoSmithKline (New 2013). Likewise, as shown above, a degree of legal insecurity for situations of unauthorized onward transfer remains. On the other hand, against the background of recent developments, it is clear that once agreements are in place these will be used as standard agreements for all transfers, making further negotiations largely unnecessary.

The WHO PIP Framework as a pool 329 Thus, despite the potential hurdles in negotiations, the SMTA2 can be considered a huge improvement as the agreement provides a framework within which the actors can manoeuvre. It facilitates the ABS process and provides certainty as to what the two parties can expect. Furthermore, unlike before the PIP Framework, when negotiations were conducted on bilateral basis (often involving developing countries), it is the WHO that negotiates the final SMTAs which introduce further checks and balances, thereby increasing the effectiveness and, more importantly, the equity – an issue that is discussed further below. Two experiences from the H5N1 crisis are telling in this regard. First, as mentioned above, Indonesia found it too burdensome to negotiate individual MTAs for each material transfer during the peak of the crisis, which resulted in the unauthorized transfer that had triggered Indonesia’s decision to withhold samples until the GISN/GISRS was updated. Standard MTAs could easily have prevented this situation. Furthermore, when Indonesia learned about the Australian patent application, it reached out to other health care companies to explore options for a bilateral deal. Eventually it signed a contract with US pharmaceutical company Baxter Healthcare to develop a vaccine (Khor 2007). The contract foresaw an exchange of virus samples by Indonesia, and relevant technology and expertise for vaccine production by Baxter Healthcare. The aim was to enable Indonesia to build sufficient capacity for vaccine production within its own country to substantially reduce its supply dependency. Indonesia, however, reported that Baxter Healthcare had been the only company that contacted the ministry and that was ready to abide by Indonesia’s condition and to enter into an MTA with strong benefit-sharing obligations. This was only the case because other companies knew that they could receive the samples elsewhere under better (or no) conditions. The standard use of MTAs across all WHO member states again could have prevented this situation. It is also worth noting that while this bilateral Baxter Healthcare agreement may have proved positive for Indonesia to some extent, this may not have been the case for most other developing countries. Indonesia is among the few developing countries that have been able to develop some of their own production capacity (Sedyaningsih et al. 2008: 485). Knowledge and technology transfer can thus be helpful for its infant industry. But this cannot be said about most developing countries. Moreover, the benefits of such bilateral agreements only materialize if the company actually ends up being the one to develop vaccines and treatment. This is difficult to foresee. Finally, in the case of bilateral deals, only resource-providing countries can benefit while other countries (which might be more vulnerable to a pandemic) would be left out. This is exactly what the PIP Framework tries to redress. In this regard, Indonesia’s experiences underline the need for compulsory SMTAs that govern each transfer. Without SMTAs, countries can be confronted with transfer terms

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being dictated by companies that could access the samples elsewhere, potentially under even better conditions. Such lengthy processes in times of emergency are neither in the interest of the providing country nor the recipient. The resulting stress might eventually even induce the providing country, which is also dependent on the vaccine supply, to agree to a transfer without an MTA or on the basis of weak terms. EFFECTIVE EXCHANGE OF BENEFITS

The second element of ‘exchange effectiveness’ that needs to be subject to analysis is effectiveness regarding the exchange of benefits in the form of vaccines and medical treatment. As mentioned above, the WHO is meant to coordinate this form of benefit sharing on the basis of the SMTA2s that it negotiates and administers. The Director General has been tasked to develop an appropriate mechanism for resource allocation as benefits are shared through the WHO rather than on a bilateral basis. But while different options have been explored and discussed, a mechanism has yet to be put into place. It will need to be seen how this will be designed and whether it will be able to achieve resource allocation in an effective manner. In either case, what already seems clear at this stage is that a physical stockpile administered by the WHO will not be feasible, among other reasons, due to the fast mutation of virus strains (Wyman 2009; WHO 2010 [Global Action Plan 2010 Report]). Various logistical problems will thus have to be overcome before timely and non-burdensome benefit delivery can be guaranteed. Moreover, enforcement of benefit-sharing obligations could prove problematic. This is particularly true for cases of illegal onward transfer. In this context, it is worth noting that, in the case of antiviral treatment and vaccines, the correlation of products and original genetic resources is fairly easy to establish. Vaccine development is based on the original biological samples while each specimen with distinct genetic characteristics can be traced down to one place of collection. Unlike for other genetic resources, the use of PIP material is thus easy to detect and can be clearly associated with access to one particular sample. Likewise, due to strict biosafety requirements for infectious material, the shipment of PIP specimens is fairly well documented. Almost all unauthorized use of PIP material is thus likely to be detected, as the example of Indonesia has shown. However, legal enforcement could prove difficult in instances of illegal onward transfer, as these situations are not subject to the contract terms set out in the SMTA2. As said above, the ToRs of GISRS institutions may be revoked if these engage in unauthorized onward transfer. But no similar sanctions exist for non-GISRS institutions that transfer GISRS materials to other non-GISRS institutions without notifying the WHO in advance and without any MTA in place. As contracts, SMTAs could certainly be enforceable in domestic

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court systems. Article 13 of SMTA2 on the governing law is subject to negotiations and it will need to be seen how this plays out in the future. In either case, this avenue would only be available to sanction the institution that illegally transferred material to a non-GISRS institution. Since the illegally receiving non-GISRS institution would not be bound by the SMTA2, however, unauthorized utilization and related benefit sharing could not be enforced on the basis of SMTA2 – there simply would not be any applicable agreement. The Framework agreement also does not foresee automatic or even compulsory dispute resolution. In fact, this was one of the most contentious points, and member states consciously decided to leave the matter unsettled as they could not agree. Demands for binding arbitration had been rejected during the negotiations by a number of countries, first and foremost the USA.16 In this context, it remains unclear whether a recipient of unauthorized material could apply for intellectual property right (IPR) protection for a product developed on the basis of the ‘illegal’ GISRS specimen. This would need to be determined on the basis of national intellectual property law. The discussion is closely linked with the ongoing ‘disclosure’ discussion in the ABS regime (Vivas-Eugui 2012). In summary, one could say that the enforcement of restrictive access rights in the case of the PIP Framework might be much easier than in other pool systems and also under other ABS systems. The interface of IPRs and unauthorized onward transfer, however, could pose future challenges. Here the system continues to rely on the cooperation of all authorized users and the uncertainties related with this approach can hamper a timely and efficient transfer of material and benefits. Equitable benefit sharing The second point that needs to be assessed is the basis upon which benefit sharing takes place and whether it sufficiently ensures that benefit sharing takes place in an equitable manner. As mentioned above, for the purpose of this chapter, the term ‘benefits’ refers only to those listed in SMTA2. This agreement obliges the recipient to engage in at least two different benefit-sharing activities, which exclude GISRS services. Depending on whether the recipient manufactures vaccines, antivirals or other PIP-relevant products, SMTA2 provides for different alternatives. Manufacturers may choose either to donate and/or reserve their products and/or to grant licences for free or on fair mutually agreed terms. Where the products are not vaccines or antiviral treatments, manufacturers may also choose to engage in capacity building or technology transfer efforts instead. In contrast, Brazil, India and Indonesia, the main demandeurs in the negotiations, had insisted that recipients should be obligated to share benefits in a three-fold manner by granting royalty-free, non-exclusive, transferable licences to developing

332 Marie Wilke countries; providing a donation of 10 per cent of the production to the WHO; and providing tiered pricing.17 Though all of these kinds are reflected in the final Framework agreement, the SMTA options lack the inflexible and binding language that had been proposed by this group of countries. Moreover, in order to balance the interests of developing countries and manufacturers, the agreement recognizes that ‘flexibility is important in negotiating with all manufacturers’ and mandates that manufacturers’ choice must be informed by a recipient’s ‘nature and capacities’ (PIP Framework: Article 4). While this can shield smaller companies from excessive commitments, the commitment that one’s ‘nature and capacities’ must inform one’s choice, also means that the more important a product for global pandemic response is, the higher the contribution that is expected. On the other hand, useful results continue to depend on the negotiation skills of the WHO. As said above, to date, only one SMTA2 has been signed, the text of which is not yet publicly available (New 2013). Therefore, it is difficult to assess how these notions and requirements will play out in practice. Nonetheless the PIP Framework includes a number of important indications on the matter of equity, first and foremost regarding the principles that will inform benefit sharing, which will be introduced and assessed below. Most importantly, the objective to improve global health rather than simply rewarding countries for their individual actions, i.e. the submission of national specimens, generally applies to all kinds of benefits mentioned in the PIP Framework, including those of GISRS and non-GISRS institutions. In line with this general objective, benefits are expected to be coordinated with ‘particular attention to policies and practices that promote the fair, equitable and transparent allocation of scarce medical resources (including, but not limited to, vaccines, antivirals and diagnostic materials) during pandemics based on public health risk and needs, including the epidemiology of the pandemic’ (PIP Framework: Article 6.1, emphasis added). This principle is a huge success as it bases the system on global pandemic response objectives rather than bilateral reward-based benefit sharing. As a consequence, the most affected countries and those with limited access to needed vaccines will be the first to receive vaccines in times of emergency – rather than those that shared the utilized specimen unless they are also experiencing health risks and needs. The same principles apply to the utilization of the permanent H5N1 vaccine stockpile. Despite this positive development, however, the current obligations are unlikely to ensure world-wide vaccination in times of pandemic as the benefit margins identified in the SMTA2 are unable to meet actual demand in times of emergency. Against this background, and considering the high profit margins in the sector, higher compulsory benefit-sharing obligations would have been desirable. The dual dependency, the

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contributions from countries and the relatively high profit margins in the area of vaccine development certainly justify a fairly high benefit-sharing requirement. Companies also ‘know what they buy when they buy it’ as the genetic potential of virus specimens is known prior to access – unlike in other cases of genetic resources where research is conducted on a trialand-error basis – and the benefit-sharing obligations only become relevant once a company has actually developed a product and is able to profit from its investments. Against this background, the obligatory benefit-sharing provisions indeed seem rather weak and insufficiently balanced. The same has been said about the foreseen financial contribution by companies to the GISRS running costs. Fifty per cent or roughly USD 30 million has been criticized as too low by a number of civil society actors (Bern Declaration and TWN 2007). On the other hand, in the view of the author, all benefit-sharing obligations also need to be evaluated in the context of comparable health and ABS systems. In particular, the latter aspect is interesting as the PIP negotiations collided with the CBD negotiations on the Nagoya Protocol on access and benefit sharing, which were equally concerned with ABS in health emergencies. While it is beyond the scope of this chapter to discuss the details, it should be noted that the outcome of these negotiations regarding ABS in health emergencies stays far behind the achieved benefit-sharing obligations contained in the PIP Framework (though the CBD negotiations were not limited to influenza vaccines, thus having a considerably wider scope).18 This is also true for non-health-related ABS discussions where one usually speaks about benefit sharing in the area of 1 per cent rather than 10 per cent. Furthermore, it should be noted that the insufficient supply of vaccines is mainly the consequence of existing production shortages. Even higher benefit-sharing obligations on their own would thus be unable to secure world-wide protection. Instead, it would be important to link benefit sharing more clearly with the efforts to increase world production capacity. In that regard, while the Framework agreement itself speaks about tiered pricing, technology transfer and capacity building, it only requires that ‘member states urge vaccine manufacturers’ to engage in such activities with the SMTA2, calling upon recipients to consider such additional support. In particular, in relation to other WHO efforts, first and foremost the GAP, it would have been important for the PIP Framework to provide an ‘impulse’ for new capacity building and technology transfer projects and generate funding to meet capacity increase objectives as identified in the GAP.19 Simply higher benefit-sharing obligations in the form of greater in-kind contributions, on the other hand, would not support the objective of overcoming production constraints in the long term in order to enable real global pandemic preparedness. Taking account of this need, during the 2012 WHA countries decided that 70 per cent of contributions be allocated for preparedness and 30 per cent for response activities, a

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proportion that may be modified by the Director General in case of a pandemic. This allocation is an attempt to rectify some of the system’s shortcomings, and, if implemented in a suitable manner, can indeed ensure that the PIP Framework has an even stronger impact on overcoming supply shortages in the long term. The system’s limitation to pandemic influenza viruses, on the other hand, is not addressed through these new guidelines, despite this limitation equally threatening the effectiveness of pandemic response through the benefit-sharing mechanism. Seasonal influenza vaccines and pandemic influenza vaccines are inextricably linked, which also translates to the relationship of capacity building in both areas. In fact, the GAP states that an increase in seasonal influenza vaccine demand and supply is the key to increasing pandemic influenza vaccine production capacity.20 One issue cannot be addressed without the other, which is also reflected in other WHO instruments that usually address the two areas jointly. In that light, it seems counterproductive to separate the two issues in the PIP Framework.

Lessons for other international systems Unlike viruses, in particular influenza viruses, most pathogens (including bacteria, fungi, helminthes (worms), protozoa and prions) have benign and even auxiliary functions. Bacteria and fungi, for instance, are essential for our ecosystem and the human body (Cleaveland et al. 2001). These dual functions make most non-viral pathogens valuable genetic resources that can be used for the development of pharmaceuticals and other genetic resource-based products that are unrelated to the disease caused by the original pathogen. In the case of influenza viruses, on the other hand, utilization is almost exclusively directed at the development of vaccines or antiviral treatments – be they for humans or animals (Wilke 2012: 10). At the point of access, providers and recipients are thus aware of the intended use and the potential benefit that would arise from that use. This predictable relationship facilitates the regulation of the influenza virus ABS in comparison with other pathogens or, more generally speaking, other genetic resources. Two other factors that considerably facilitate the regulation of influenza viruses related to ABS are the dual dependency of actors (with the industry relying on access to viruses from predominantly developing countries and developing countries depending on the development of vaccines) and the time pressure under which the system operates. As described above, all involved actors are dependent on the timely and efficient exchange of resources, whether these are related to the biological materials needed for vaccine development or the actual vaccines. This urgency is further increased by the constant, rapid and substantial mutation of influenza viruses with pandemic potential, which necessitates a constant exchange of specimens. In other cases mutations might also be relevant but they

The WHO PIP Framework as a pool 335 occur less frequently and in a less predictable manner, making a standing exchange system, such as the GISRS, unfeasible. Moreover, since influenza vaccine development is considered a significantly profitable business, a high industry demand exists for such timely exchanges. This further distinguishes influenza viruses from viruses that cause, for instance, neglected diseases where research is predominantly incentivized through public investment programmes. It is these different factors that jointly allow the functioning of the GISRS and the PIP Framework. If the exchange of materials were less frequent, of less interest to the private sector or of less importance, a permanent exchange system would not be needed or feasible. Since influenza viruses emerge and function in a very particular way, it is thus unlikely for the system to be replicated in other health sectors. For the same reasons, it will also be difficult to replicate the system in an attempt to implement the Nagoya Protocol obligations for other pathogens or other health emergencies. Despite the system’s limitations there are important lessons to be learned from the PIP Framework for collaborative public health research and other ABS systems. The first relates to the positive effect of material transfers taking place on the basis of standard terms. The H5N1 outbreak has shown the difficulties that countries face when having to negotiate MTA terms under time pressure without public or international review and without standard terms. This is true not only for the health area but for any benefit sharing. The need for MTAs can emerge suddenly and unexpectedly when a resource is identified as a potential asset by a foreign user. Many developing countries have not been able to develop domestic standard practices to react to such requests, and the economic evaluation of genetic resources without prior research can take a considerable amount of time. In many instances, however, potential users would want the supplying country to react quickly, which puts government negotiators under pressure. Also, genetic resources other than viral material are predominantly held by developing countries, more precisely the group of twelve like-minded megadiverse countries that jointly hold a large majority of all living organisms. These countries can struggle with the successful and meaningful negotiation of MTAs where large enterprises approach the government to grant access. The discussion above has shown that many of these difficulties could be overcome by the use of standard terms. These could be negotiated at international level under the auspices of the CBD or they could be jointly developed by interested countries that then agree to base their negotiations predominantly on these agreements. Likewise, the PIP example has shown that a certain degree of flexibility in these terms is needed. Each access is informed by different user objectives, timeframes, potential and foreseeable values, and relationships. This necessitates individual terms that can respond to the situation at hand.

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However, as in the case of the PIP Framework, these may well be based on binding standard terms that provide for a benefit-sharing margin within which the negotiators can move. The current standard terms proposed by the Nagoya Protocol do not fulfil this function of binding, defined but lightly flexible standard terms. The second lesson relates to the ‘pool nature’ of the system. The standing mechanism links all the different actors that are relevant to the whole process of genetic resources utilization – beginning with the accessing and ending with the production of the vaccine or antiviral treatment, and even the improvement of research and development processes. Furthermore, the pool itself addresses the intermediate products of each step by capturing, for instance, relevant virological information and candidate vaccine viruses needed for vaccine development. By ensuring that these resources (intangible or physical) are also made available to other users and that the principals represent all different groups of actors needed for pandemic response, the process is optimized, which can reduce the time needed to develop and apply vaccines. In general, the fact that the PIP Framework is a standing system substantially reduces the administrative and other hurdles that can be associated with accessing genetic resources. Legal security is provided for all actors and the procedures are transparent, known (since they build upon procedures that have been in place for decades) and stable, which allows efficient (and not only effective) cooperation. The third lesson relates to the underlying idea of the PIP Framework. Benefit sharing under the Framework agreement is informed by the global need for vaccines and medical treatment in times of pandemic for the greater good. Pandemics can only be prevented and fought when the disease is contained and eventually eliminated during pre-pandemic stages. This necessitates global action and global access to vaccines and treatment. In that regard, the agreement follows the idea of ‘needs justice’ rather than ‘entitlement justice’. Unlike in other ABS regimes such as the Nagoya Protocol, countries are not being rewarded for the conservation of the resource (again it should be noted that the aim of the Framework is actually the elimination rather than conservation of the resources). In addition, benefit sharing does not take place on a bilateral basis with the provider of the original specimen being the recipient of benefits. Instead, generated benefits are shared with all members that need access. During the Nagoya Protocol negotiations, many countries had argued for the exact opposite, i.e. for integrating these types of utilization in the normal ABS obligations rather than creating specialized rules. However, the above discussion has shown that in times of emergency, collaboration and a pool approach are needed instead of bilateral bargaining. Only collaboration informed by joint objectives will be able to generate meaningful responses. The final lesson is closely related to the previous point. The establishment of a clear criterion that informs the process of benefit

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sharing is critical to ensuring fair and equitable benefit sharing. The PIP Framework refers to the benchmark of ‘public health needs and risks’ in this regard. This is not a quantitative but a qualitative benchmark. The same idea also informs the negotiations of SMTA2. Having such a universal criterion can help design the most appropriate responses while taking account of individual circumstances. At the same time, it helps overcome problems related to ‘normal’ benefit-sharing situations where equity is often more incidental than causal as negotiation outcomes depend on the abilities and human resources of resource providers. Two different providers of the same resource can thus end up with very different shares of benefits. The fact that the PIP Framework can refer back to the International Health Regulations and the WHO PIP mandate is certainly helpful and not necessarily replicable in all areas (Wilke 2012). But the general lesson to take from this is that ABS is as successful as it is cooperative. This is true for cooperation regarding process and substance: standardized procedures, cooperation at every stage of development, a multilateral approach to benefit sharing rather than a provider/user approach, and an understanding that equity is the underlying objective of ABS regimes, need to be the basis for such fruitful cooperation. The PIP Framework is by no means flawless in this regard. Especially the weak linkages with the GAP and other efforts that aim to overcome global production capacity shortages can be criticized from a public health perspective (Wilke 2012; Wilke 2013 (forthcoming)). But as an ABS regime and a common pool on genetic resources, the PIP Framework is a useful framework that should serve as a reference point for future regime building.

Notes 1 The views presented in this chapter are the author’s own and do not necessarily reflect the views of ICTSD or any of its funding institutions. The author is grateful for comments on an earlier version received at the Fairness and BioKnowledge – The Nagoya Protocol workshop organized in June 2011 by the University of Warwick Law School, and for the valuable assistance of Matt Fleszar. Any mistakes and omissions are the author’s alone. 2 WHO defines ‘pandemic’ as the global spread of a virus infecting large proportions of the human population (WHO ‘What is phase 6?’). 3 The term H5N1 will be used to refer to the Asian lineage, subclade 2 of HPAI-A (H5N1). 4 For more information on H5N1, see the WHO website (WHO ‘Influenza at the Human-Animal Interface’). 5 For the latest update, see the WHO website (WHO (2012a) ‘Confirmed human cases of avian influenza A(H5N1) reported to the WHO’). The numbers here are from the 22 February 2012 update. 6 In principle, three of these guidelines stipulated that WHO laboratories ‘will seek permission from the originating country/laboratory to co-author and/or publish results obtained from the analyses of relevant viruses/samples’. Principle four further held that ‘there will be no further distribution of

338

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10 11 12 13 14

15

16 17

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viruses/specimens outside the network of WHO Reference Laboratories without permission’. These guidelines would usually inform the negotiation of material transfer agreements (MTA) between the providing party and the WHO system (Sedyaningsih et al. 2008: 485). This assumes that two vaccine doses are needed per person due to the lack of pre-existing antibodies. More advanced adjuvants used in the vaccines, however, could reduce this estimate to one dose per person, thereby reducing the total number of vaccines needed to around 7 billion (See Khurana et al. 2010). The WHA Resolution was adopted on 24 May 2011. The document is numbered 64.5 and entitled Pandemic influenza preparedness: sharing of influenza viruses and access to vaccines and other benefits (WHO 2011b [PIP Framework]: 1). The PIP Framework can be accessed online at http://whqlibdoc.who.int/ publications/2011/9789241503082_eng.pdf, viewed 28 January 2013. The IHR (WHO 2005) were adopted in 2005 and came into force on 15 June 2007. They are binding upon all member states and aim to prevent, protect against, control and provide a public health response to the international spread of disease (Article 2 IHR (2005)). Importantly they apply to public health emergencies of international concern (Article 13.1). The agreement speaks about a ‘haemagglutinin antigen that is distinct from those in seasonal influenza viruses’ (PIP Framework: Article 4.2, paragraph 4). It elaborates: ‘these being candidate vaccine viruses generated by reverse genetics and/or high growth re-assortment’ (PIP Framework: Article 4.1, paragraph 1). For information about the Pool for Open Innovation against Neglected Tropical Diseases, visit http://www.bvgh.org/LinkClick. aspx?fileticket=BOLmqvC-QGM=, viewed 26 March 2012. For information about the Medicines Patent Pool, visit http://www. medicinespatentpool.org, viewed 26 March 2012. The Shipping Fund Project provides free shipping of specimens from national laboratories to WHO CCs or H5 Reference laboratories. It extends to all National Influenza Centres that have shared with GISRS (WHO ‘Logistic activities’). FluNet is a WHO-managed database for virological information, e.g. the number of viruses by sub-type detected in a certain area. Information is submitted by GISRS and other collaborating laboratories. The epidemiological information managed by FluNet is central to the monitoring of viruses. Information is publicly available through a web-based form (WHO ‘FluNet’). Informal interviews with delegates conducted by the author. In their SMTA 2 Proposal, these three countries wanted the following wording: ‘Recipients shall:…grant to WHO royalty free, non-exclusive, transferable license with respect to such rights. WHO may then transfer this license to developing countries, …provide donations of 10 per cent of production to WHO stockpile…[and] provide under tiered pricing vaccines, antivirals, and diagnostics’ (WHO 2011a [SMTA 2 Proposal]: Article 4.1). Whether viruses or pathogens should be more generally included in an ABS instrument, whether special benefit-sharing obligations were feasible and whether expedited access in times of health emergencies should be mandatory were issues first raised in the CBD negotiations that led to the adoption of the Nagoya Protocol. The issues became central to the negotiations, with a last minute compromise safeguarding the general outcome. The compromise is reflected in Article 8(b) Nagoya Protocol which calls upon member states, when developing and implementing their access and benefit-sharing

The WHO PIP Framework as a pool

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legislation or regulatory requirements, to ‘pay due regard to cases of present or imminent emergencies that threaten or damage human, animal or plant health, as determined nationally or internationally’, while ‘parties may take into consideration the need for expeditious access to genetic resources and expeditious fair and equitable sharing of benefits arising out of the use of such genetic resources, including access to affordable treatments by those in need, especially in developing countries’. The legal interrelation of the two instruments (the Nagoya Protocol and the PIP Framework), however, continues to be debated, with some member states arguing that the PIP Framework is a specialized ABS instrument within the meaning of the Nagoya Protocol, thereby excluding pandemic influenza viruses from the Protocol’s scope. For a legal analysis, see Wilke (2012). 19 The GAP is the outcome of large-scale consultations with a broad range of stakeholders (including WHO member states, national immunization programmes, regulatory authorities, researchers and pharmaceutical companies) that aims to ‘increase the supply of a pandemic vaccine and thereby reduce the gap between the potential vaccine demand and supply anticipated during an influenza pandemic’ (WHO 2006 [GAP]). In order to achieve this, experts identified three goals. First, an increase in seasonal influenza vaccine demand through the promotion of seasonal vaccination programmes; second an expansion of production capacity, mainly in developing countries; and third, endorsement of research and development to develop more efficient production procedures and vaccines. As part of objective two, in 2007 and 2009, the WHO selected 11 developing-country institutes to receive grants to establish or expand influenza vaccine manufacturing capacity. While the programme is generally considered successful, it has struggled with a lack of technology transfer – one critical component in strengthening production capacity in developing countries in order to reduce geographical imbalances. Greater incentives to grant access to knowledge and technology is considered key in building further global production capacity (Friede et al. 2011). 20 Since other diseases like HIV, malaria and tuberculosis are considered to pose greater public health risks, seasonal influenzas have long been neglected as a health risk in developing countries. This, in turn, has led to a low demand for seasonal vaccines, such that private producers can supply 100 per cent of vaccines for seasonal influenzas. However, as it is, the same plants that produce influenza vaccines for viruses with pandemic potential cannot provide enough stock during a pandemic. Giving a higher priority and directing more funds to seasonal influenza at the international and national level would have huge dividends for production capacity during pandemics (WHO 2010).

References Bern Declaration and TWN (Third World Network) (2007) ‘Agreement on influenza virus sharing and benefit sharing is a step forward but has some shortcomings’, 19 April, http://www.evb.ch/en/p25019292.html, viewed 14 February 2012. Cleaveland, S, Laurenson, MK and Taylor, LH (2001) ‘Diseases of humans and their domestic mammals: pathogen characteristic, host range and the risk of emergence’, Philosophical Transactions of the Royal Society of London, Series B, Biological Sciences, 356 (1411), 991–999.

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Collin, N, de Radiguès, X and the World Health Organization H1N1 Vaccine Task Force (2009) ‘Vaccine production capacity for seasonal and pandemic (H1N1) 2009 influenza’, Vaccine, 27 (20 August), 5184–5186. Friede, M, Palkonyay, L, Alfonso, C, Pervikov, Y, Torelli, G, Wood D and Kieny MP (2011) ‘WHO initiative to increase global and equitable access to influenza vaccines in the event of pandemic: supporting developing country production capacity through technology transfer’, Vaccine, 29 (Suppl. 1), A2–A7. Gerhardsen, TIS (2007) ‘Indonesia avian flu stance reveals potential weakness in global system’, Intellectual Property Watch, 8 March, http://www.ip-watch. org/2007/03/08/indonesian-avian-flu-stance-reveals-potential-weakness-inglobal-system, viewed 14 February 2012. Hess, C and Ostrom, E (eds) (2007) Understanding knowledge as a commons: from theory to practice, The MIT Press, Cambridge, MA. Khor, M (2007) ‘Indonesia to share bird-flu samples only if there is new system’, Third World Network, 23 February, http://www.twnside.org.sg/title2/wto.info/ twninfo507.htm, viewed 14 February 2012. Khor, M and Sashikant, S (2007) ‘Winners and losers in the sharing of avian flu viruses’, Third World Network, 9 May, http://www.twnside.org.sg/title2/avian. flu/news.stories/afns.004.htm, viewed 14 February 2012. Khurana, S, Chearwae, W, Castellino, F, Manischewitz, J, King, LR, Honorkiewicz, A, Rock, MT, Edwards, KM, del Giudice, G, Rappuoli, R and Golding, H (2010) ‘Vaccines with MF59 adjuvant expand the antibody repertoire to target protective sites of pandemic avian H5N1 influenza virus’, Science Translational Medicine, 2 (15), 15. Kieny, MP, Costa, A, Hombach, J, Carrasco, P, Pervikov, Y, Salisbury, D, Greco, M, Gust, I, LaForce, M, Franco-Paredes, C, Santos, JI, D’Hondt, E, Rimmelzwaan, G, Karron, R and Fukuda, K (2006) ‘A global pandemic influenza vaccine action plan’, Vaccine, 24 (40–41), 6367–6370. Mara, K (2008) ‘WHO members slow to bridge disagreements at pandemic flu meeting’, Intellectual Property Watch, 11 December, http://www.ip-watch. org/2008/12/11/who-members-slow-to-bridge-disagreements-at-pandemicflu-meeting, viewed 14 February 2012. New, W (2007) ‘WHO to continue high-priority revision of pandemic flu system’, Intellectual Property Watch, 14 December, http://www.ip-watch.org/2007/12/14/ who-to-continue-high-priority-revision-of-pandemic-flu-system, viewed 14 February 2012. New, W (2013) ‘WHO plan for pandemic flu proceeds with questions’, Intellectual Property Watch, 28 January 2013, http://www.ip-watch.org/2013/01/28/whoplan-for-pandemic-f lu-proceeds-with-questions/?utm_source=daily&utm_ medium=email&utm_campaign=alerts, viewed 31 January 2013. Ostrom, E (1990) Governing the commons: the evolution of institutions for collective action, Cambridge University Press, Cambridge. Paul, W (2003) Fundamental immunology, Lippincott Williams and Wilkins, Philadelphia, PA. Sedyaningsih, ER, Isfandari, S, Soendoro, T and Supari, SF (2008) ‘Towards mutual trust, transparency and equity in virus sharing mechanism: the avian influenza case of Indonesia’, Annals of the Academy of Medicine, Singapore, 37 (6), 482–488.

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Vivas-Eugui, D (2012) ‘Bridging the gap on intellectual property and genetic resources in WIPO’s Intergovernmental Committee (IGC)’, International Centre for Trade and Sustainable Development Intellectual Property Programme, Geneva, Issue Paper No. 34, January 2012. WHO (World Health Organization) (2005) International health regulations, Second edition, Geneva, http://whqlibdoc.who.int/publications/2008/9789241580410 _eng.pdf, viewed 18 January 2013. WHO (2006) [GAP] ‘The Global Action Plan to increase supply of pandemic influenza vaccines’, WHO, Geneva, http://whqlibdoc.who.int/hq/2006/ WHO_IVB_06.13_eng.pdf, viewed 21 January 2013. WHO ‘What is phase 6?’ http://www.who.int/csr/disease/swineflu/frequently_ asked_questions/levels_pandemic_alert/en/index.html, viewed 14 February 2012. WHO (2009) [PIP Guidance] ‘Pandemic influenza preparedness and response: a WHO guidance document’, WHO, Geneva, http://whqlibdoc.who.int/ publications/2009/9789241547680_eng.pdf, viewed 14 February 2012. WHO (2010) [Global Action Plan 2010 Report] ‘The Global Action Plan to increase supply of pandemic influenza vaccines: report of the fourth meeting of the WHO Global Action Plan of the Advisory Group: Nha Trang, Viet Nam, 6 May 2010’, WHO, Geneva, http://whqlibdoc.who.int/hq/2010/WHO_ IVB_10.08_eng.pdf, viewed 14 February 2012. WHO (2011a) [SMTA 2 Proposal] (‘SMTA 2 Proposal from Brazil, India and Indonesia’), in Pandemic influenza preparedness: sharing of influenza viruses and access to vaccines and other benefits: Report by the Director General, 12 January, EB128/4, WHO, Geneva. WHO (2011b) [PIP Framework] ‘Pandemic influenza preparedness Framework for the sharing of influenza viruses and access to vaccines and other benefits’, WHO, Geneva, http://whqlibdoc.who.int/publications/2011/9789241503082_ eng.pdf, viewed February 2012. WHO (2012a) ‘Confirmed human cases of avian influenza A(H5N1) reported to WHO’, http://www.who.int/influenza/human_animal_interface/H5N1_ cumulative_table_archives/en/index.html, viewed 14 February 2012. WHO (2012b) ‘Pandemic influenza preparedness: sharing of influenza viruses and access to vaccines and other benefits: report of the Advisory Group’, Report by the Director General to the 65th World Health Assembly, A65/19, 25 May 2012, WHO, Geneva, http://apps.who.int/gb/ebwha/pdf_files/WHA65/ A65_19-en.pdf, viewed 28 May 2012. WHO ‘FluNet’, http://www.who.int/influenza/gisrs_laboratory/flunet/en, viewed 14 February 2012. WHO [GISRS] ‘Global Influenza Surveillance and Response System (GISRS)’, http://www.who.int/influenza/gisrs_laboratory/en, viewed 14 February 2012. WHO ‘Influenza at the Human-Animal Interface (HAI)’, http://www.who.int/ influenza/human_animal_interface/en, viewed February 2012. WHO ‘Logistic activities’, http://www.who.int/influenza/gisrs_laboratory/ logistic_activities/en, viewed 14 February 2012. WHO SAGE (World Health Organization Strategic Advisory Group of Experts in Immunization) (2007) ‘Information note – experts recommend WHO stockpile up to 150 million doses of avian flu vaccine’, 16 November, http://www.who.int/ immunization/sage/SAGE_note_19_11_07.pdf, viewed 14 February 2012.

342 Marie Wilke Wilke, M (2012) ‘The 2010 Nagoya Protocol and implications for global health governance’, in Morgera, E, Buck, M and Tsioumani E (eds), The Nagoya Protocol in perspective: implications for international law and implementation challenges, Brill/ Martinus Nijhoff, Leiden. Wilke, M (2013 forthcoming) ‘Multilateral cooperation on pandemic influenza preparedness and response: ensuring access to vaccines through access and benefit sharing’, LEAD Journal (accepted). Wyman, O (2009) ‘Options for the design and financing of an H5N1 vaccine stockpile: key findings and study methodology’, Bill and Melinda Gates Foundation.

17 The multilateral system of the International Treaty on Plant Genetic Resources for Food and Agriculture Lessons and room for further development1 Evanson Chege Kamau International Treaty on Plant Genetic Resources for Food and Agriculture. What is it? The International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA, hereinafter IT or Treaty) is an international agreement dealing with plant genetic resources for food and agriculture. The Treaty was adopted in November 2001 by the Food and Agriculture Organization of the United Nations (FAO) Conference2 after seven years of negotiations and came into force on 29 June 2004, 90 days after 40 governments had ratified it.3 It is legally binding upon ratification and is in accordance with the Convention on Biological Diversity (CBD). The IT, in line with the CBD objectives, aims to foster conservation and sustainable use of extremely important plant genetic resources for food and agriculture (PGRFA4), upon which all humankind depend. These resources are quasi globally co-owned, having been developed by farmers all over the world and exchanged for over 10,000 years.5 No country is selfsufficient; all depend on crops and the genetic diversity within these crops from other countries and regions.6 As a consequence, the future of the agriculture sector globally is highly dependent on their conservation and sustainable use. The IT also aims to share, in a fair and equitable way, the benefits arising from the utilization of these PGRFA.7

The multilateral system Conservation and sustainable use of genetic diversity involves much research on genetic material; likewise the development of modern agriculture. To maintain pest and disease resistance in major food crops or to develop desirable traits, such as drought tolerance or improved flavour, for example, plant breeders require fresh supplies of genes from the farms, forests and fields of the developing world. Developing the high-

344 Evanson Chege Kamau yielding, élite cultivars of modern agriculture depends on a steady stream of new, exotic germplasm. Without access to traditional landraces and their wild relatives, modern agriculture would be seriously endangered. In order to achieve its aims amidst many access challenges, the IT establishes a system of access and benefit sharing (ABS) for plant genetic resources for food and agriculture (PGRFA) called the Multilateral System (MLS) of the IT. The MLS deals with ABS issues of certain PGRFA, which contracting parties (CPs) consider vital for food security, as they provide for more than 80 per cent of human calorie intake from plants8 and based on which all countries are interdependent.9 They comprise 35 food crops and 29 forage genera of global importance, making up 64 crops that the IT lists in Annex I. The IT aims at ensuring their continual availability and thus makes them the subject of a common pool. The common pool is a system of managing, providing and using these PGRFA with the participation and co-operation of as many countries as possible. It is also a system of sharing benefits arising from the utilization of those PGRFA, according to the criteria it establishes. This is what is referred to as the multilateral system of the Treaty. The goal of the MLS is to give scientific institutions and private sector plant breeders the opportunity to work with, and potentially improve, the materials stored in gene banks or even crops growing in fields10 in furtherance of the objectives of the Treaty.11 Its success depends on the parties’ readiness to abide strictly by its rules. The IT acknowledges the sovereign rights of states over their PGRFA as well as the authority to determine their access, subject to national legislation and in accordance with the CBD.12 However, upon ratification of the IT, contracting parties, in exercise of their sovereign rights, agree to establish an efficient, effective and transparent system of facilitating access to Annex I PGRFA and sharing benefits from their utilization. By doing so, they forego their right to subject those PGRFA to general ABS rules as foreseen in the CBD and apply measures agreed upon by all parties. According to the IT, parties are obliged to make their Annex I PGRFA, i.e. those under the management and control of the Contracting Parties and in the public domain,13 available to all and expeditiously.14 This should be done without restrictions or subjection of the recipient to conditions of bilateral benefit sharing.

Functioning of the multilateral system There are three major processes, or building blocks, that shape the functioning of the multilateral system: building an information database of the parties’ material, access to material, and sharing of benefits from utilized material (see Figure 17.1).

The Multilateral System of the ITPGRFA 345 Building information database of material The building of an information database of the parties’ plant genetic resources for food and agriculture that are listed under Annex I of the IT consists of two steps: their formal notification and their material notification. What is called ‘notification’ in practice is giving information by the parties themselves to the Treaty Secretariat through letters (known as notification letters) about the genetic diversity under their management and control or jurisdiction and in the public domain.15 As the aim of a notification requirement, however, is not merely to produce a list of such PGRFA but, as discussed below, to give effect to the multilateral system by making available information that is easily usable, the second step is the most decisive for the functioning of the multilateral system. It involves the provision of information or passport data16 related to the crops stored in the gene banks of contracting parties through adequate and public documentation and, therefore, comprises the de facto inclusion of material in the MLS. Thus, the essence of notification is not to determine what material is included in the multilateral system.17 The mere fact that certain PGRFA are listed under Annex I as well as a country becoming party to the IT implies that its PGRFA are automatically included in the MLS.18 Notification is therefore instrumental in identifying and letting other CPs know what Annex I PGRFA are materially available under the multilateral system and, particularly, users within the territory of those CPs.19 The importance of notification can also be viewed differently, namely in regard to entities which are non-parties to the IT (e.g. natural and legal persons). Without such entities notifying their Annex I PGRFA, they literally remain outside the ambit of the MLS (as such, they are not automatically included) and consequently limit the dynamism of the multilateral system. Before a party notifies, it has to establish which Annex I PGRFA are under its management and control and in the public domain. The identification of which accessions are included takes place at the national level and it is sometimes unclear which ones are under the management and control or jurisdiction of the parties due to varying national agreements, 20 or policy, legislative and administrative structures regarding plant genetic resources for food and agriculture (Chiarolla and Jungcart 2011: 16). In a federal government, for example, the question of the collections’ ownership might arise between the federal states and the federal government. Thus, the situation varies from one country to another.21 While all PGRFA held by government institutions, such as genebanks, are regarded as being under the management and control of the state in some countries and, therefore, included in the MLS (Chiarolla and Jungcurt 2011: 16), similar institutions might be formally regarded as independent legal persons, but under the management of a national PGRFA policy framework, in other countries

346 Evanson Chege Kamau (Chiarolla and Jungcurt 2011: 16). Chiarolla and Jungcurt (2011: 14, 16), for example, consider the collections of the Association pour l’Etude et l’Amélioration du Maïs (Pro-Maïs), a private maize breeders’ association for maize study and improvement in France, and the Association Française des Semences de céréales à paille et autres espèces Autogames (AFSA) as being under the management and control of France which is a party as they are part of the French national PGRFA framework with the National Institute for Agricultural Research (INRA). That discussion will be resumed further below. Still, PGRFA may also be held under public/private partnerships in some countries (Chiarolla and Jungcurt 2011: 16). These and other complexities22 can seriously hinder or delay the process of notification. The multilateral system primarily includes PGRFA held in the ex situ collections of the International Agricultural Research Centres (IARCs) of the Consultative Group on International Agricultural Research (CGIAR), 23 which currently hold almost 700 thousand accessions.24 In addition, states are required to encourage private persons (natural and legal) within their jurisdictions to include their Annex I plant genetic resources in the system.25 All other holders of such genetic resources, i.e. non-contracting parties as well as natural and legal persons within their jurisdictions, are invited by contracting parties also to do so with a view to achieving the fullest possible coverage of the MLS.26 It is important that the material is adequately and publicly documented to make it effectively accessible and usable as facilitated access (for plant breeding and conservation) is the essence of the MLS.27 Once notified, the Secretariat makes the information on material collected in the multilateral system available to all via the IT’s website.28 Hence, the MLS is a common pool – of information on the PGRFA covered – through notifications (i.e. a virtual common pool) and not through the physical collection and storage of resources in a single location – the physical location of the material is not interfered with. Access to material The second step is access to the material. This involves first getting information on the location of material and its passport data, and then requesting access from its holder/provider. Finding information As already mentioned, notified PGRFA, related information, as well as their location, are made available on the Treaty website. To get such information, a number of steps must be followed. These have been described in Kamau (2011)29 on a seven-level, step-by-step basis which is summarized below.

The Multilateral System of the ITPGRFA 347 The first step, of course, is to log onto the website of the IT – which, at the time of carrying out this study, was located at http://www.planttreaty. org – where there is a hyperlink to the SMTA. Below the pdf e-copy of the SMTA is a hyperlink entitled ‘Information on collections in the multilateral system’. It contains information on countries that have made notifications, with brief notification statements, and finally, a hyperlink leading to further detailed information on the PGRFA. The next step involves searching for information on a country-bycountry basis. Once a specific country has been selected, the search may continue based on the criterion of ‘species and their utilization’, or ‘ex situ collections’, or ‘in situ occurrences’. Further search criteria depend on which criterion has been selected. Following Kamau’s example,30 if the criterion ‘ex situ collections’ is the preferred search criterion, ‘species’, ‘country of origin’, ‘holding institution’ and ‘advanced search’ would be the next search criteria. Further, if ‘country of origin’ is selected, an alphabetical list of countries is displayed showing the total number of accessions per country, which also include non-Annex I crops. Each country has one to three further search criteria which either display all accessions, ‘all results’, or accessions according to ‘institute code’ or ‘species’. Using this procedure, a single search result has been extracted for demonstration purposes from ‘all results’ of material originating from Kenya and notified by (or found in ex situ collections) in Germany (see Table 17.1). Requesting access After detailed information concerning a crop or crops has been accessed, any interested (natural or legal) person under the jurisdiction of a contracting party may make a request for access from the party holding the material. The transfer is made using the SMTA, which spells out the rights and obligations of the parties under Articles 5 and 6. Except for PGRFA within in situ conditions that are still subject to national legislation, or such standards as may be set by the Governing Body (GB)31 in absence of national legislation, the SMTA requires contracting parties and the IARCs to provide access to their PGRFA according to its terms and conditions. Terms and conditions pertaining to usage and transfer of material • • •

The provider is obliged to grant access expeditiously (Article 12.3 (b) IT). There is no need to track individual accessions in provider states (Article 12.3 (b) IT). Access is, in principle, free. If a fee is charged it should not exceed the minimal cost involved (Article 12.3 (b) IT).

348 Evanson Chege Kamau Table 17.1 Sample of a single search result Plant genetic resources in Germany Country of origin: Kenya (KEN) Number of results: 207 > Sorting/sorted by: Accession number Number of result Institute code By species Crop name Accession number Accession name Date of receipt Country of origin Status of location Location Biological status of accession Donating institute (Code) Accession number of donor Kind of storage Website with additional information Multilateral system (MLS) Data status

OK

1 IPK Genbank Avena sp. Oat AVE 3686 FLUGHAFER 20031114 Kenya (KEN) Other (Elaborate in REMARKS field) (99) Elburgon, 5 km Suedl Wild (100) DEU001 53770 Seed collection (10) See website Ja [Yes] 24.04.2008

Source: IT website.

Any associated, available, non-confidential, descriptive information should be made available together with the PGRFA (Article 12.3 (c) IT). •

•

•

Accessed materials have to be used solely for the purpose of conservation for research, breeding and training for food and agriculture. The scope of utilization, however, excludes chemical, pharmaceutical and/or other non-food/feed industrial uses (Article 12.3 (a) IT). In exchange for free access, the recipient is not allowed to commercialize, claim or establish intellectual property rights on PGRFA or their genetic parts or components in the form received from the MLS (Article 12.3 (d) IT). PGRFA protected by intellectual and other property laws have to be made available consistent with relevant international agreements and national laws (Article 12.3 (f) IT).

The Multilateral System of the ITPGRFA 349 •

Access to PGRFA under development, including by farmers, is at the discretion of the developer (Article 12.3 (e) IT).

The provider is obliged periodically to inform the GB about material transfer agreements entered into (Article 5 (e) SMTA). Transfer to another person or entity, as well as to any subsequent transfers, must be made under the same terms and conditions (of the SMTA) and notified to the GB, after which the transferor has no obligations vis-à-vis the actions of subsequent recipients (Article 6.4 SMTA). •

•

The parties also agree to provide facilitated access to appropriate PGRFA for food and agriculture in the MLS for purposes of reestablishment of agricultural systems in cooperation with disaster relief coordinators (Article 12.6 IT). The recipient may seek intellectual property protection for newly developed brands suitable for such protection (Articles 12.3 (d) and 6.2 SMTA, by implication).

Terms and conditions pertaining to benefit sharing from utilized material The multilateral system establishes far-reaching duties to share benefits accruing from the utilization of plant genetic resources for food and agriculture from the MLS fairly and equitably. These include both nonmonetary and monetary benefits that have to be paid into a trust fund established by the GB.32 Obligation to share non-commercial benefits In principle, the IT allows usage of the PGRFA under the MLS for noncommercial purposes, implying that benefits shared are basically nonmonetary, including those listed under Article 13, i.e. exchange of information,33 access to and transfer of technology34 and capacity building.35 Obligation to share commercial benefits However, Article 13.2 (d) of the IT foresees situations where the material is commercialized. In such cases, monetary and other benefits of commercialization must be shared: a) when a recipient commercializes a PGRFA product that incorporates material accessed from the MLS, and/ or b) if the recipient of the material uses the material to make a product and claims intellectual property rights (IPRs) over it. If the rights are assigned to a third party, the benefit-sharing obligations of the SMTA must be transferred to that party. Food processing industries that benefit from PGRFA for food and agriculture are also required to make benefitsharing contributions on a voluntary basis.36

350 Evanson Chege Kamau Ways of sharing commercial benefits The IT suggests ways of sharing monetary and other benefits of commercialization which include: •

• •

involvement of private and public sectors in activities identified under Article 13 through partnerships and collaboration in research and development (R&D); payment of an equitable share of benefits from commercialization into the trust fund of the MLS; and placement of a sample of the product into the MLS collection, after expiry or abandonment of the IP, for further research and breeding purposes.

Monetary benefit to be paid into the trust fund from commercialization comprises 1.1 per cent of the sales of the product, less 30 per cent or 0.5 per cent of the overall sales.37 To achieve fair and equitable sharing of benefits, the GB has discretion to occasionally review the levels of payment.38 Direct and indirect payments39 of the benefits paid to the trust fund are paid to farmers in all countries, especially developing countries and countries with economies in transition, who conserve and sustainably use PGRFA for food and agriculture.40

Figure 17.1 Flow of material and benefits within the multilateral system (source: FAO, Rome 2011)

The Multilateral System of the ITPGRFA 351 Exemption from sharing commercial benefits The benefit-sharing obligation is waived: •

•

if a commercialized product that is a PGRFA and incorporates material accessed from the MLS is available without restriction to others for further research and breeding;41 (In these cases the payment is voluntary.42 The GB had a five-year period of assessment from when the IT came into force to determine whether mandatory payment should also apply to this category (Article 13.2(d). At the time of writing this book no information existed to that effect.) for small farmers from developing countries and in countries with economies in transition – at the discretion of the GB.43

Lessons for pooling The MLS offers some lessons for pooling of other genetic resources. The lessons summarized below only pertain to its mechanisms: notification, access and transfer, and benefit sharing. Lessons in regard to possible grounds for pooling based on established practices in the use and exchange of genetic resources for food and agriculture in the main subsectors of food and agriculture are discussed in Chapter 10 by Louafi and Schloen. Lessons in this chapter have been summarized according to the three criteria explained in Chapter 1: vertical equity, horizontal equity and facilitation of public research and development.44 Vertical equity The MLS creates space for participation/involvement of both developed and developing countries. Whereas developed countries can participate with technical know-how by using their laboratories to build on what the farmers in developing countries have accomplished in their fields,45 developing countries can access new technology from developed countries. It also creates a good system of transferring technology as the users themselves are obliged to make it available and for free. This spares developing countries the burden of searching for, and the danger of acquiring, obsolete technology as well as the costs such a process might entail. The MLS strengthens the obligation of users to share benefits with providers. In the SMTA, the percentage of benefits to be shared from commercialization is expressly defined and comprises 1.1 per cent of the sales of the product, less 30 per cent, or alternatively 0.5 per cent of the overall sales. Subsequent recipients are under the same benefit-sharing obligation. A fund is established with benefit-collection and benefitdistribution functions.

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The MLS establishes a system of monitoring the downstream movement of materials by obliging the recipients to report each transfer downstream to the GB. That way, providers of materials do not have to provide the materials for use and additionally have the burden of monitoring their use downstream. This should also limit abuses and hence ensure there are more monetary as well as non-monetary benefits in the fund for providers. It is hard to assess the impact of this requirement as the Secretariat has only one record of a reported example of an established chain of SMTAs (IT/GB-4/11/12). The calculation of payments for the commercialization of material from the MLS is harmonized. In addition, revisions and variations to the level of payment are centralized under the sole discretion of the GB. This should not only help eliminate fraudulent practices but also reduce the administrative burden and the creation of anti-competitive conditions. Such opportunities represent the interests of source countries as they are free to get involved in R&D activities and the sharing of results and other benefits. Of course, developing countries’ participation in R&D is currently mostly theoretical, as most of them lack the capacity to do so. To achieve de facto participation, there is need to assist such countries in building capacity as envisaged in Article 13.2 (c) of the IT. There is a more detailed critique of the distribution of monetary benefits below. Horizontal equity The pool establishes its own criterion for the distribution of benefits, which is not necessarily dependent on the source country or country of origin of the material. The criterion for the disbursement of funds is based on need for conservation and sustainable use.46 In a way, this is also just because plant genetic resources for food and agriculture truly are a common heritage for humankind, being the result of the corporate contribution of people from many nations worldwide. Although formal law recognizes sovereign rights of states over their natural resources,47 there cannot in reality be a claim of ownership over such resources or the benefits arising from their utilization by one state or community. Nonetheless, the process for the distribution of funds according to this criterion produces some flaws, which are discussed below. Public R&D The MLS establishes free and simplified access to genetic diversity for the purposes of research that is beneficial to conservation and sustainable use. As the PGRFA are disconnected from the states of origin, the material and knowledge are freely exchanged. In addition, access to the MLS does not require breeders to negotiate contracts with individual gene banks48 as

The Multilateral System of the ITPGRFA 353 access and benefit sharing are regulated through the SMTA. This facilitates research, innovation and the exchange of information by eliminating restrictions caused by lengthy, bureaucratic and unclear procedures that often drastically increase transaction costs. The system of monitoring the downstream transfer of material created by the multilateral system is yet another positive element for R&D. That is because the burden and costs of monitoring that would otherwise accrue to one recipient are effectively shared between all recipients of the material.

Critique and suggestions for further development This section critically analyses the MLS with a view to its further development. This may be looked at in terms of its material or legal scope. With further development of its material scope, we imply its expansion to cover other genetic resources for food and agriculture, viz. plant genetic resources for food and agriculture not included under Annex I of the Treaty, that is, animal, forest, aquatic, microbial genetic resources and biological control agents. Views have been expressed that it would be difficult to extend the coverage of the MLS to other sectors.49 That question is beyond the scope of this chapter and hence our focus will only be on the further development of the legal scope of the MLS, which means the evolution of its rules, especially with a view to achieving its full potential. The most outstanding features of the multilateral system that can be used to measure its achievements are what we might refer to as the pillars of its functionality: notification and inclusion, access and transfer, and benefit sharing. By any standard, the same features should be the most suitable yardstick to gauge its overall success. In the following, we will critically analyse these features based upon suggestions for the further development of the MLS. Notification and inclusion The current information on the IT website (as of January 2013) shows that 29 contracting parties, 17 international centres and five natural or legal persons have notified their Annex I plant genetic resources to the Secretariat of the IT.50 Whereas the notifications of the international centres portray great success in the notification process, 51 the number of contracting parties and natural or legal persons that have notified is very small.52 This seems to portray a different picture altogether. Of utmost interest in this regard are the reasons behind the small number of notifications by countries as the Treaty obligations are addressed to them (in particular), being its signatories. A particularly important question is why barely a quarter of all contracting parties have made notifications.

354 Evanson Chege Kamau As discussed above, upon becoming a party to the IT, each country also agrees to the establishment of a multilateral system of PGRFA listed under Annex I that is efficient, effective and transparent.53 The aim of such a system is to facilitate access to those genetic resources and to share the benefits of their utilization in a fair and equitable manner.54 This emphasizes the fact that it is the act of notification that gives effect to facilitation. The mere knowledge that all Annex I PGRFA of certain entities are included in the MLS does not make any sense for a potential user if it is impossible to establish which PGRFA they are. The de facto availability of Annex I PGRFA is made possible only through notification. Current records show that more than half of the notified collections totalling 1.3 million belong to the international centres of the CGIAR. Looking at the number of contracting parties that have notified their Annex I PGRFA in comparison to the total number of contracting parties of the Treaty, it is evident that the total number of notified collections of contracting parties is meagre. Having said this, it would be fair to state that, numerically, most Annex I PGRFA are still not available for use or facilitated access through the MLS. That, of course, tremendously limits the intended impact of the system, as facilitated access is its first building block. A number of arguments have been made as to why the notification process has been slower than anticipated. Analysed under three subheadings, this study restricts itself to three main arguments of importance for the focus of the book, that is, financial, technical and institutional incapacitation of many developing countries, imbalanced rights and obligations and impact of IPRs. A few other arguments will be mentioned in the course of the discussion of the main arguments, especially the first two. Financial, technical and institutional incapacitation of many developing countries Whereas it is much easier for any country to notify how many accessions of plant genetic resources for food and agriculture are maintained, the gist of notification, as already explained, is to make full and easily accessible information available on individual accessions. 55 Plant breeding and conservation, which are the purposes of facilitated exchange, can only make use of such information.56 To this end, each contracting party is required to indicate ‘the website where detailed data on the composition of the collection and user procedures to order samples are readily available, and the website [URL address] that provides access to the collection’s database’.57 Many developing countries lack the financial, technical and institutional capacity to adequately and publicly document their PGRFA.58 But it is not only at this level that incapacitation is noticeable. From the published notification letters, it is evident that some developing countries have not successfully characterized all listed PGRFA,

The Multilateral System of the ITPGRFA 355 for example Zambia, Malawi and Madagascar.59 Some are still struggling with the task of characterization – which must precede identification and documentation – due to limited capacity.60 The general picture hence shows that out of 29 contracting parties that have notified their PGRFA,61 barely half of them have made information available that is easily accessible and usable. Until they are able to carry out the tasks that make it possible, PGRFA under their management and control and in the public domain cannot be considered to be effectively in the MLS. Such a shortcoming not only limits the effectiveness of the pool, but also research and development activities based on Annex I PGRFA.62 Countries in this category will therefore need assistance in the form of capacity building and funds in order to cope with the challenges involved. Taking this into consideration, it is probably worthwhile for the Governing Body, while allocating funds, to consider the possibility of specifically targeting activities of such parties that involve characterization and creation of the infrastructure needed for de facto inclusion of their PGRFA into the MLS. Indeed this should be included in the criteria for assessment of applications for funds. Certainly, it is also important to extend our thinking beyond capacity and inquire whether indeed all developing countries that have not made at least a simple notification as a first step of compliance lack capacity to notify. These concerns will be discussed in more detail below. Imbalanced rights and obligations Since the negotiations leading to the adoption of the ITPGRFA, the issue of inclusion of plant genetic resources for food and agriculture in a common pool has repeatedly suffered from setbacks caused by imbalanced rights. Principally, there were controversies over the scope of intellectual property rights (mainly breeders’ rights), which were seen by developing countries as continually and increasingly restricting their rights, especially those of farmers, over their own PGRFA to the advantage of developed countries.63 This led to the reluctance of developing countries to include many vital PGRFA in the multilateral system,64 which substantially reduced its scope to what is now referred to as Annex I crops. But even then, the de facto inclusion of the few selected PGRFA, as mentioned above, has not yet seen the success that was anticipated. Whereas the cracks in the foundations upon which the MLS is built might be responsible to a certain extent, the weakness pointed to here seems to be a product of what should be the Treaty’s greatest strength, that is, facilitated access. The analysis looks at facilitated access for, and inclusion by, non-party holders of PGRFA, with a focus on natural and legal persons and the PGRFA transfer practice of international centres. In that light, it gives an assessment of their impact on notification by parties as well as inclusion by non-parties.

356 Evanson Chege Kamau Concerning natural and legal persons, Article 12.2 of the IT requires that such entities that are under the jurisdiction of any contracting party be provided facilitated access to plant genetic resources for food and agriculture under the MLS. It states that ‘such access shall also be provided to natural and legal persons’, implying that they are to be accorded similar conditions as those of contracting parties. The conditions under which facilitated access between contracting parties is provided are listed in Article 12.3 and have been enumerated above. The problem with facilitated access for natural and legal persons is that, whilst they have the right to appropriate the PGRFA of the MLS just like any contracting party, they have no obligation to include their own PGRFA. The Treaty, with the aim of achieving the widest coverage of the MLS, only requires contracting parties to encourage private holders of PGRFA within their jurisdictions to include their PGRFA in the MLS, not to coerce. According to the report of the GB, incentive measures that parties may use to encourage them include: but are not limited to, financial or fiscal incentives to holders of material (e.g., eligibility for public funding schemes)…policy and legal measures, administrative actions setting up domestic procedures for inclusions, or awareness raising efforts (especially at the level of farmers)’.65 As of now, only one of the five inclusions listed on the IT website can be regarded with certainty as falling under the category of natural and legal persons, that is, that of the Association of Communities in the Potato Park. As mentioned above, some authors are of the view that the Association pour l’Etude et l’Amélioration du Maïs (PRO-MAÏS), a private maizebreeders’ association for maize study and improvement in France, and the Association Française des Semences de céréales à paille et autres espèces Autogames (AFSA) are both within the French national PGRFA framework being with the National Institute for Agricultural Research of France (INRA) and hence under the management and control of France (Chiarolla and Jungcurt 2011: 14, 16; Santilli 2012: 135). There are, however, contrary views that these collections cannot be said to be under the control of the French government, but rather only under its management as, although they are managed by national institutions, they are constituted with both public and private material, thus forming a public–private partnership.66 This is tricky though as in principle it also implies that being in a public–private partnership, the collections might not have full control over the material. This ambiguity is likely to persist until the French government clarifies the status of publicly managed collections. Similar ambiguity also prevails regarding material notified by the Universidad de Costa Rica and Maseno University (Kenya) in the capacity

The Multilateral System of the ITPGRFA 357 of legal persons. Both are public (state) institutions/universities and therefore state entities. Are the PGRFA they hold then not under the management and control of their respective governments? As mentioned above, state institutions holding PGRFA might be formally regarded as independent legal persons in some countries, but under the management of a national policy framework. The Costa Rican constitution, for example, guarantees such entities a high degree of autonomy.67 The lingering question, however, still is, does such autonomy grant the institution full control over the material, including the right to dispose of it? A comparable situation that gives some clarity to this discussion is that of Malaysia which is discussed in detail by Nijar in Chapter 7, including through the analysis and interpretation of legal documents and court rulings. In his analysis of the status of the Malaysian Agricultural Research and Development Institute (MARDI) and the University of Malaya (UM), both public institutions, Nijar shows that in spite of the high degree of autonomy accorded to MARDI by the act of parliament that set it up, its key functions ‘are to be undertaken by, or with the approval of or concurrence of the Minister of Agriculture and sometimes also the Minister of Finance’ and ‘more particularly as regards PGRFA, the Minister is empowered to determine policies regarding the collections and direct the board as to the conditions for any grant of access’. Thus the act makes it clear that MARDI’s collections are under the management and control of Malaysia and hence its Annex I material is included in the multilateral system. On the other hand, although there are provisions that suggest that public universities are under the management and control of the government, Nijar’s analysis of the status of one of the universities (i.e. the UM) shows that the university and the collections centres it set up (e.g. the herbarium of the University of Malaya) function under a certain academic rubric which gives them full independence to manage their affairs, including in regard to Annex 1 PGRFA held by them (Nijar Chapter 7). His analysis concludes that their material is not subject to the MLS of the Treaty. This cannot be generalized in regard to all Malaysian universities, however, and therefore the status of any of them is subject to interpretation. A quick conclusion to this discussion would be like a ‘rule of thumb’ as the focus and scope of this chapter do not permit an in-depth analysis that is capable of reaching a definitive conclusion as to whether the inclusions of the two French institutions as well as those of the Universidad de Costa Rica and Maseno University (Kenya) can be regarded as being under the management and control of contracting parties or not. However, the observation in this chapter that, until now, success in including material held by natural and legal persons in the MLS is negligible cannot be altered whatever the conclusion. The IT foresaw in Article 11.4 that the GB would make an assessment of progress in inclusion two years after the IT came into force and decide

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whether access should continue to be facilitated for those legal and natural persons that have not included their PGRFA in the MLS, or take other measures it deemed appropriate. During its second session (Rome, 2007) when it had to make this assessment, the GB postponed it to its next session in Tunis in 2009 (Santilli 2012: 135). Whilst it made an assessment of the progress of inclusion of PGRFA into the multilateral system in its third session, it did not decide whether to stop facilitated access for legal and natural persons for failure to include their PGRFA into the MLS, or take other appropriate measures, but postponed that decision to its fourth session in Bali, Indonesia (14–18 March 2011) (Santilli 2012: 135). This decision was postponed once more to the next (fifth) session, planned for 2013 (Santilli 2012: 135). It means that currently no legal basis exists to stop free-riding by such entities as they can continue accessing the PGRFA of others from the MLS while not making their own available.68 It has been pointed out that issues of legal uncertainty and administrative burden arising out of the provisions of the Treaty as well as the effects of using the SMTA as a legal document for transfer of materials form part of the reasons that impede natural and legal persons from including their PGRFA (Chiarolla and Jungcurt 2011: 18ff.). Since most concerns pointed to difficulties with the use of the SMTA, they will be discussed below under ‘access and transfer’.69 In reality, the legal situation concerning contracting parties is not much different. It is true that inclusion as foreseen under Article 11.2 should entail notification as a mandatory obligation for the Treaty signatories. The loophole in this requirement, however, is in the failure of the Treaty to construe enforcement and punitive measures in this regard. Article 11.4, which mandates the GB to make an assessment of the process of inclusion by natural and legal persons, could have been a good basis if it had been extended to contracting parties, even while excluding nonfacilitation from punitive measures.70 Unfortunately, the article does not make this provision. Consequently, contracting parties are not obliged to prove that they have proactively taken measures to notify, which does not preclude them from requesting materials from other contracting parties that have been effectively included in the MLS.71 In addition, the Treaty does not inhibit transfer of Annex I material by contracting parties to nonparty entities on a bilateral basis.72 In effect, some contracting parties as well as non-party entities do not feel the urgency to notify their own PGRFA (Chiarolla and Jungcurt 2011: passim; Halewood et al. 2013, p. 13ff). Moreover, exchange outside the MLS is a way of circumventing or evading the numerous obligations of the SMTA. This, again, is a loophole in the MLS for free-riding. There are two possible options regarding natural and legal persons (within the jurisdictions of contracting parties) that do not effectively include their PGRFA in the multilateral system. The first option would be to couple inclusion with access and to enforce them strictly on the basis of

The Multilateral System of the ITPGRFA 359 reciprocal terms. That means only natural and legal persons that have included their PGRFA should be allowed to access material from the MLS. As mentioned, this is envisaged by the Treaty, and the GB is expected to make a decision in this regard during its fifth session. The second option would be to attach a payment, in the form of a tax per sample accessed from the MLS, by such natural and legal persons. That might serve as an incentive to include in order to gain free access. Although Halewood et al. (2013, p. 18f.) use the term ‘free-riding’ cautiously in recognition that some countries have long contributed their PGRFA to the collections of the international centres of the CGIAR, member countries of the Treaty that have done so (i.e. contributed their PGRFA into the collections of the international centres) should detach themselves from the clique of free-riders by at least notifying such information to the Secretariat with a list of the PGRFA contributed to such centres. However, that should not exempt them from notifying the rest of Annex I PGRFA (if any) as well as eventually providing the full description of the material. Such measures would also help to create confidence in the MLS and motivate other members. Similar sentiments have also been expressed vis-á-vis facilitated access by the international centres of the CGIAR (Halewood et al. 2013, p. 12ff.; Chiarolla and Jungcurt 2011). These centres have a long-standing tradition of allowing unrestricted access to their collections for purposes of agricultural research. They consider themselves as holding the collections in trust for the international community and therefore they themselves cannot claim ownership of the collections or intellectual property rights over them (Halewood et al. 2013, p. 13). In other words, these collections are global common goods. The centres also distribute them under similar conditions (Halewood et al. 2013, p. 13). When they placed them in the International Undertaking according to agreements with the FAO in 1994, pending negotiations of the ITPGRFA, it was done on this understanding (Halewood et al. 2013, p.13). The same understanding prevailed when they placed them in the MLS of the ITPGRFA in 2006 under agreements with the GB (Halewood et al. 2013, p. 13). Therefore, even after the Treaty came into force, the centres could not be prevented from continuing their old practice of facilitating access to all, IT members and non-members alike. Whilst the practice of the international centres is justifiable, first because it is based on the principle that the centres hold a public good in trust for the international community, and second because many Treaty non-members have also long contributed to the collections, it nevertheless has adverse effects on the MLS. Considering that over 50 per cent of the currently 1.3 million collections of the MLS are held by the international centres, it means that users can still access a plethora of Annex I material without subscribing to the IT framework. Of course, some IT non-member states such as the USA hold plenty of collections73 which they distribute to users all over the world, predominantly without discrimination and with

360 Evanson Chege Kamau minimal conditions – usually just a phytosanitary certificate (Halewood et al. 2013, p.14). More disappointing is the fact that some member states appropriating the gaps in the Treaty continue to provide PGRFA samples to non-members using the SMTA, for example, Germany and the Netherlands (Halewood et al. 2013, p. 14). The combined effect of all these challenges and others has a major impact on the MLS, further dampening the motivation of many states (including Treaty members) to participate in the MLS, and ratify the Treaty, and their interest in doing so. In summary, all the circumstances that result in the imbalance in rights and obligations both dissuade some contracting parties from notifying and, at the same time, make natural and legal persons reluctant to include. They act as a disincentive to ratify the Treaty and participate in the MLS. In fact, this, together with benefit-sharing considerations (see below), seems to be the crux of the cracks in the MLS. Access and transfer The success of the MLS, as far as access and transfer of material is concerned, will be measured here by the volume of materials exchanged and the ease in requesting, accessing and transferring materials. In regard to the volume of materials exchanged, current records indicate that a total of 8,500 transfers of MLS material take place every week and 200 SMTAs are concluded each day (see Figure 17.1).74 This information, however, does not specify the contributions of the entities involved in this activity. The only concrete information showing the activity of a specific entity concerns the distribution of materials by the international centres over a number of years. This shows that in the first three years (i.e. from 1 January 2007 to 31 December 2009) that the IARCs started using the SMTA to distribute materials, the centres distributed a total of 1.15 million samples of PGRFA.75 Approximately 84 per cent of the samples were sent to developing countries or countries with economies in transition, 9.5 per cent to developed countries and 6.5 per cent to CGIAR centres. From the total number of distributions, 18 per cent were sent by the centres’ genebanks, and 82 per cent from the breeding programmes.76 For a number of reasons, the information above does not help us analyse how successful the actual access and transfer from contracting parties is. First, the number of transfers that take place per week as well as SMTAs concluded per day include those of the centres. Logically, the bulk of those transfers are undertaken by the international centres, taking into account that most of the materials effectively included in the MLS belong to them. Second, the distributions from the centres include non-Annex I material to which the Treaty obligations do not apply. For example, the 1.15 million samples distributed by the centres in the period from 2007 to 2009 included Annex I and non-Annex I material: 1 January 2007 to 31 July 2008 (Annex I material) and 1 August 2008 to 31 December 2009

The Multilateral System of the ITPGRFA 361 (both Annex I and non-Annex I material).77 Third, the greatest challenges in implementing the obligations of the Treaty are expected in individual member countries that, unlike the international centres with a long history of distribution of samples, have a dearth of capacity and skills. Regarding the ease of requesting, accessing and transferring materials, experiences of and views about the use of the SMTA might give us some insight. As mentioned, contracting parties are obliged to grant facilitated access to other contracting parties through the multilateral system, and to natural and legal persons under the jurisdiction of any contracting party subject to the condition that the latter also include their PGRFA in the MLS. Facilitated access is to be provided using a SMTA. According to the figures cited above, current records only show distributions of the centres’ genebanks and breeding programmes (using the SMTA). Thus, although the centres have indicated success and ease in using the SMTA,78 there is, at present, no record of how individual countries have been dealing with access requests or transfer of materials to recipients. It is hoped that such assessments will be possible once the Secretary of the IT has put in place the necessary tools for recording and reporting the use of SMTA.79 Potential recipients of materials from the international centres have expressed their reservations about the use of the SMTA. Their concerns have been categorized in three groups: thresholds for and the duration of obligations to make payments; requirements that records be kept in perpetuity; and agreement clarity.80 These concerns are not caused by the practical use of the SMTA but rather by scepticism over its legal nature, which results in potential users declining to use it. Thus, they do not help us with the current analysis and will not be discussed further. Benefit sharing The benefit-sharing factor will be analysed according to the criteria of payment of benefits into the benefit-sharing fund and distribution of funds. Payment of benefits The criterion of paying benefits into the benefit-sharing fund of the MLS has been discussed above. The SMTA stipulates that 1.1 per cent (less 30 per cent) of the benefits arising from the utilization of the material from the MLS or, alternatively, 0.5 per cent of the sales of any products and of the sales of any other products that are PGRFA belonging to the same crop (Annex 2.1 and Annex 3.1 respectively) will be paid into the benefitsharing fund of the MLS if the product from the material is not made available for use by others through the MLS. Two major criticisms are made in this regard. The first concerns the rate of alternative payment (0.5 per cent of the overall sales), which is considered very high. Such a

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high rate is likely to dissuade potential recipients from requesting materials from the MLS. In fact, there is an indication that some PGRFA users choose to receive material from other sources, for example, from the United States Department of Agriculture Agricultural Research Service (USDA-ARS) in order to avoid the benefit-sharing conditions/obligation of the multilateral system (Hammond 2011). Chiarolla and Jungcurt (2011) predict that lobbying is likely to take place at different levels in an effort to achieve more moderate conditions. They suggest that such conditions may include the following elements: • • •

a preferential rate for crop-based benefit-sharing payments; limited or no tracking through the SMTA; and payments on an annual basis that could essentially operate as a global gene bank fee for free access to particular crop species.

The second criticism relates to the full exemption from the sharing of benefits for users who make the product available for use (further research and breeding) by others through the MLS. Whereas making the results of further research and breeding available is probably a greater benefit than a monetary one, many developing countries might not be able to use the product/knowledge made available due to technological incapacity. That leaves others with such capacity (overwhelmingly developed countries) to benefit, including those that have not notified their Annex I PGRFA. Thus, a sort of inequity occurs. The obvious reaction would be to demand that, in addition to making the product/knowledge available through the MLS, users should make a small percentage of monetary payment into the BSF. Such an approach is envisaged by Article 13.2d(ii) of the Treaty. It says that the GB may also assess, within a period of five years from the entry into force of this Treaty, whether the mandatory payment requirement in the MTA shall apply also in cases where such commercialized products are available without restriction to others for further research and breeding. We are of the opinion that such an approach is likely to serve as a disincentive for further research and breeding, the very activity that aims to foster the use of PGRFA and consequently discourage users from accessing material from the MLS. As already seen, there are other sources of PGRFA with fewer restrictions from which such users can access material. In order to avoid such repercussions, we suggest that the GB should rather take a different option of raising funds according to UN scales in order to compensate/cover costs for building or upgrading the capacity of such parties to use PGRFA.

The Multilateral System of the ITPGRFA 363 Distribution of funds Again, payments made into the benefit-sharing fund of the MLS are not necessarily shared with the source country of the PGRFA. According to Article 13.3 of the Treaty, they ‘should flow primarily, directly and indirectly, to farmers in all countries, especially in developing countries, and countries with economies in transition, who conserve and sustainably utilize plant genetic resources for food and agriculture’. Theoretically, this criterion should promote equity based on the special nature of PGRFA. However, the process of distribution of funds seems to be flawed, with shortcomings that produce results that are inconsistent with the very equity the criterion aims to achieve. The flaws are visible in the application procedure for funds, criteria for distribution per se and admissibility to apply for funds. As illustrated in Figure 17.1, funds are distributed from the BSF through calls for proposals for projects on food security, adaptation to climate change and agrobiodiversity conservation. The proposals go through a selection process, which should be transparent. The flaw with such a selection process is that the assessment of proposals is likely to favour the best-written and convincing proposal, which might not necessarily reflect the reality on the ground. To be taken into consideration is also the fact that many entities involved in conservation and sustainable use of PGRFA in developing countries lack skills in writing good proposals. The consequence is that the best proposal might succeed in getting funds rather than the best project. The Secretariat is considering all relevant issues in order to improve the selection process in the future.81 For example, a move from a single project approach to a more holistic approach, taking into account the diverse needs and capacities of different countries and stakeholders, has been proposed.82 We suggest that an assessment of the PGRFA conservation and sustainable use activities of the applicant on the ground should be considered as a vital criterion in carrying out the selection. Closely related to the shortcomings of the distribution procedure is the fact that the criterion for the distribution of funds per se might not always result in equity. Whereas the non-bilateralism principle upon which the multilateral system is built is vital for its future operation and success,83 what cannot be ignored is that some contributors of material in the MLS invest heavily – not only in terms of funds – in order to produce material that is usable by others for further research and breeding.84 An example is the Eastern Africa Plant Genetic Resources Network (EAPGREN). Its importance is made even more evident by the fact that the network covers a large block of the African continent comprising Sudan, Eritrea, Ethiopia, Kenya, Uganda, Rwanda, Burundi and Madagascar. In addition, being under the umbrella of the Association for strengthening Agricultural Research in Eastern and Central Africa (ASARECA), the importance of its

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activities spread more widely, impacting not only the eastern, but also the Central African region. Like other such networks, its funding unfortunately relies mainly on fund-raising, which is not always fruitful or reliable.85 That no funds at all have yet trickled down from the BSF to support and ensure the continuity of the conservation and sustainable-use activities of many such networks, in spite of the fact that users benefit from their value added PGRFA accessed from the MLS, is not only disappointing86 but also inequitable. It is important at this point to emphasize that the interpretation of Article 13.3 qualifies such entities to receive funds from the BSF. Language such as ‘primarily…to farmers’ and ‘indirectly, to farmers’ indicates first, that it is not only farmers who qualify, and second, that networks that collaborate closely with farmers and upon which their activities are mainly based are also entitled to receive funds from the BSF. While successful funding proposals may benefit from near-full or full funding, we suggest that a small percentage of funds be set aside for the constant support of continuous sustainableuse activities of parties that effectively contribute their material to MLS. That might also encourage parties to include more PGRFA than those listed under Annex I – not forgetting that one of the reasons why developing countries tried to limit the scope of the MLS was because they considered the CBD bilateral regime more advantageous, as access and benefit sharing are negotiated directly with the country providing the material and benefits flow to that country (Santilli 2012: 123). Finally, the fund distribution process is flawed by the fact that both member states and natural and legal persons can access funds from the BSF without having placed their PGRFA into the multilateral system. As a result, an applicant who has made no contribution to the MLS whatsoever might succeed in getting funds while another gets none. We suggest a strict application of reciprocity in distribution of funds, i.e. only entities that have effectively included their PGRFA in the MLS should be eligible to apply for funds. It obviously also means that those genetic resources that have been used and developed in the context of a project funded by the BSF have to be made available under the multilateral system.87 In the same spirit, the information generated under a project funded by the BSF should be made publicly available after the end of the project,88 at the latest within one year.89 And this should be a contractual condition while receiving the funds. Impact of IPRs The Treaty requires that recipients of material from the MLS do not claim ‘any intellectual property or other rights that limit the facilitated access to the plant genetic resources for food and agriculture, or their genetic parts or components, in the form received’ (Article 12.3 lit. d). When is material accessed considered no longer ‘in the form received’? In simple terms, it

The Multilateral System of the ITPGRFA 365 means that the material has gone through some (further) innovation that meets the criteria of the rights being claimed (Santilli 2012: 140). But would that imply that any level of innovation in relation to the material is ground enough to claim IPRs over it? An affirmative would mean that the mere isolation of a gene (i.e. unaltered gene) contained in the genetic material accessed from the multilateral system would be sufficient to claim IPRs, which negates the objective of the Treaty – to facilitate access to plant genetic resources (Santilli 2012: 140). One of the misleading issues is probably the lack of clarity as to what really constitutes a ‘product’ in biotechnological use, a question which has been left to legal interpretation and jurisprudence (Visser and Borring 2011: 73) as well as sectorial views.90 This ambiguity creates indecision regarding notification, especially for developing countries that, unlike developed countries, were right from the outset (and remain) opposed to IPRs over genetic material provided through the MLS (Santilli 2012: 140), an approach that hinders access to those materials. This statement in the notification letter by Malawi gives an indication of the scepticism that prevails, especially in many developing countries: ‘It is our hope that terms and conditions under standard Material Transfer Agreement of the Treaty will apply and inclusion of the material will not lead to abuse, but will facilitate access and contribution to global agricultural development.’

Conclusion The MLS appears to be highly appropriate for ABS of crops and forage that are truly global in relation to their origin and use, having originated from global human efforts of breeding as well as being a fundamental means of subsistence (and sources of nutrition) for almost everybody. It would have been inappropriate and inequitable to subject access and benefit sharing of such resources to bilateralism. The system demonstrates an exceptionally practical approach for managing plant genetic resources for food and agriculture by facilitating their access for the purpose of conservation for research, breeding and training for food and agriculture. It also establishes a mechanism for sharing nonmonetary and monetary benefits from their utilization with source countries of such plant genetic resources. This mechanism is meant to promote equity by disbursing funds according to the criterion of need for conservation and sustainable use and not necessarily of the provider country. Considering that there are many other types of genetic diversity that would benefit from facilitated access or a global and/or collective effort in order to foster their conservation and sustainable use, the multilateral system of the Treaty is an exemplary model with valuable lessons for pooling of such resources. However, it also suffers from a number of setbacks that seem to limit its ability to reach its full potential. There are challenges, for example, that

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negatively affect effective inclusion of PGRFA, open the door for freeriding and undermine the intended equity in benefit sharing.91 If the elements that have been identified in this chapter as a hindrance to its further growth, as well as other impediments, are eliminated, including through the evolution of its rules, the MLS still has a lot of space for further development.

Notes 1 This chapter has greatly benefited from interviews conducted with, as well as comments and suggestions provided by, several experts. My gratitude goes to Danielle Manzella, Kent Nnadozie, Francisco Lopez, Alvaro Toledo (all from the Secretariat of the FAO Treaty) and Dan Leskien of the FAO CGRFA for furnishing me with abundant information and materials during my research visit to the FAO, Rome, in May 2011, and also for comments provided on the draft version of this chapter. Many thanks to Abebe Demissie, Marie Schloen and Jorge Cabrera Medaglia for information provided through personal communications at Kampala, Bremen and Hyderabad, respectively, and Gerd Winter (University of Bremen), Sélim Louafi (CIRAD, Montpellier) and Gurdial Nijar (University of Malaya) for their useful guiding comments and suggestions. The responsibility for the accuracy of the content, including the interpretation of the information referenced, or any error is solely the author’s. 2 Resolution 3/2001. 3 See http://data.iucn.org/dbtw-wpd/html/EPLP057-expguide-internationaltreaty/Introduction.html, viewed 23 January 2013. 4 Plant genetic resources for food and agriculture are defined by the Treaty as ‘any genetic material of plant origin of actual or potential value for food and agriculture’. These are crucial resources in feeding the world’s population. They are the raw material that farmers and plant breeders use to improve the quality and productivity of our crops. 5 http://www.icrisat.org/icrisat-ip-links.htm, viewed 22 January 2013. 6 Ibid. 7 Article 10.2 ITPGRFA. 8 See http://www.itpgrfa.net/International/sites/default/files/edm1_full_en.pdf, viewed 23 January 2013. 9 Article 11.1 ITPGRFA. 10 Ibid. 11 Conservation and sustainable use of plant genetic resources for food and agriculture and the fair and equitable sharing of benefits arising out of their use: Article 11.1 ITPGRFA. 12 Article 10.1 ITPGRFA. Cf. Article 15.1 CBD. 13 On the term, ‘in the public domain’, the Ad Hoc Advisory Technical Committee on the Standard Material Transfer Agreement and the Multilateral System noted that the concept should be understood in the context of intellectual property law, as referring to material or information that is not subject to intellectual property rights. See GB Working Document 12 (IT/GB4/11/12), http://www.itpgrfa.net/International/sites/default/files/gb4w12e. pdf, p17. According to Nijar (see Chapter 7) ‘under management’ means ‘the capacity to determine how the material is handled and not the legal rights to dispose of the PGRFA’ whereas ‘control’ refers to the ‘legal power to dispose of the material’.

The Multilateral System of the ITPGRFA 367 14 Article 12.3 (b). 15 Article 11.2 ITPGRFA. See note 13 above. 16 Passport data is detailed information comprising identification, agronomic characteristics, morphological characteristics, organoleptic and technological characteristics, and cultural practices. 17 Interview, IT Secretariat, Rome, 23 May 2011. See also Frison C, López F and Esquinas-Alcázar J (2011) Plant genetic resources and food security. Stakeholder perspectives on the International Treaty on Plant Genetic Resources for Food and Agriculture, Earthscan, London, p. 261. 18 Ibid. 19 Ibid. See also Halewood, M (2010) ‘Governing the management and use of pooled microbial genetic resources: lessons from the global crop commons’, International Journal of the Commons, 4 (1), 404–436, 409f. 20 Interview, IT Secretariat, Rome, 19 May 2011. For a discussion of which PGRFA are considered to be under the management and control of a contracting party and in the public domain, see Correa (November 2006) and Nijar (Chapter 7). 21 See IT/GB-4/11/12, http://www.itpgrfa.net/International/sites/default/files/ gb4w12e.pdf, p. 17, viewed 22 January 2013. 22 See Chiarolla and Jungcurt (2011), p. 5; see the section of this chapter headed ‘Critique and suggestions for further development’. 23 Article 11.5 ITPGRFA. The CGIAR Consortium is an international organization that advances international agricultural research for a foodsecure future by integrating and coordinating the efforts of those who fund research and those who do the research. See http://www.cgiar.org, viewed 22 January 2013. 24 Interview, IT Secretariat, Rome, 23 May 2011. The inclusion of the IARCs is by far the largest (consisting of 693,752 collections) from the approximately 1.3 collections of the MLS. See GB Working Document 12 (IT/GB-4/11/12), http://www.itpgrfa.net/International/sites/default/files/gb4w12e.pdf, viewed 22 January 2013. The GB is charged with the power of establishing agreements with other (relevant) international institutions for the purpose of including Annex I PGRFA in the MLS (Cf. Articles 11.5 and 15.5). 25 Article 11.3 ITPGRFA. By January 2013, only five notifications had been listed on the website of the IT as natural/legal persons within the jurisdiction of a contracting party, i.e. by the Association pour l’Etude et l’Amélioration du Maïs (PRO-MAÏS), a private maize-breeders’ association for maize study and improvement in France, and the Association Française des Semences de céréales à paille et autres espèces Autogames (AFSA), both with the National Institute for Agricultural Research of France (INRA), the Association of Communities in the Potato Park, the Universidad de Costa Rica and Maseno University, Kenya. See http://www.planttreaty.org/inclusions?field_mls_noti_inclu_type_owner_ value_many_to_one=Natural+or+legal+person, viewed 22 January 2013. 26 Article 11.2 ITPGRFA. 27 See GB Working Document 12 (IT/GB-4/11/12), http://www.itpgrfa.net/ International/sites/default/files/gb4w12e.pdf, viewed 22 January 2013. 28 Through this procedure the MLS has registered to date more than 1.3 million collections (see note 24). The list of notified inclusions and a sample letter of notification can be viewed on the Treaty website, http://www.planttreaty.org/ inclusions, viewed 3 August 2012. 29 See Kamau, EC (2011) ‘The multilateral system of the FAO treaty: ABS lessons for genetic diversity of global importance’, IT visual library, http://www. planttreaty.org/virtual_library, viewed 3 August 2012. 30 See ibid.

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31 The Governing Body is the highest organ of the Treaty and is made up of all contracting parties and charged with promoting the full implementation of the Treaty – keeping in view its objectives as well as providing policy guidance on its implementation. 32 Article 19.3 (f) ITPGRFA. 33 Including characterization, evaluation, and utilization of Annex I PGRFA, respecting restrictions from intellectual property protection. The information will be made available through the Global Information System on Plant Genetic Resources for Food and Agriculture (Article 13.2 (a)), which includes more PGRFA than those listed in Annex I. 34 Including improved varieties and genetic material developed from PGRFA under MLS. These, however, are to be provided respecting applicable property rights and access laws, and in accordance with national capabilities (Article 13.2 (b)). 35 Article 13.2 (c) ITPGRFA. 36 At the time of writing, no voluntary contributions had been received from food processing industries. See GB Working Document 12 (IT/GB-4/11/12), http://www.itpgrfa.net/International/sites/default/files/gb4w12e.pdf, p. 13, viewed 22 January 2013. 37 Annexes 2 and 3 SMTA respectively. 38 Article 13.2 (d) (ii). 39 See Figure 17.1. Direct payments accrue from utilization of the material of the MLS while indirect payments are voluntary contributions made (by contracting parties, the private sector, international foundations and others) into the trust fund. 40 Article 13.3. 41 Article 13.2 8 (d) (ii). 42 Ibid. 43 Ibid. 44 See Chapter 1. 45 See http://www.planttreaty.org/content/what-multilateral-system, viewed 23 February 2012. 46 According to the report of the third session of the GB, the first 11 projects under the benefit-sharing fund of the Funding Strategy were approved in 2009. This was made possible by the generous contributions of Norway, Italy, Spain and Switzerland to the benefit-sharing fund. The report (IT/GB3/09/13) is available at ftp://ftp.fao.org/ag/agp/planttreaty/gb3/gb3repe.pdf, viewed 22 January 2013. 47 Article 15 CBD. 48 See http://www.planttreaty.org/content/what-multilateral-system, viewed 23 February 2012. 49 Interview, IT Secretariat, Rome, 23 May 2011; Marie Schloen, personal communication, Bremen, 3 April 2012. 50 http://www.planttreaty.org/content/what-multilateral-system, viewed 23 February 2012. 51 The accessions of the IARCs of the CGIAR are estimated at two-thirds of all notified accessions (Santilli 2012: 136). 52 See ibid. for regional percentages of notifications. 53 Article 10.2 ITPGRFA. 54 Ibid. 55 See Fourth Session of the Governing Body ‘Report on the implementation of the multilateral system of access and benefit sharing’, Bali, Indonesia, 14–18 March 2011, IT/GB-4/11/12, p. 9, http://www.planttreaty.org/content/gb4,

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56 57 58 59 60 61 62

63 64 65 66 67 68

69

70 71 72 73

74

viewed 29 February 2012. See also Halewood, M, Noriega, L. and Louafi, S (eds) (2013) Crop genetic resources as global commons: challenges in international law and governance, Routledge, London. Ibid. Ibid. Interview, IT Secretariat, Rome, 24 May 2011; IT/GB-4/11/12, http://www. planttreaty.org/content/gb4, viewed 22 January 2013. See http://www.planttreaty.org/inclusions, viewed 22 January 2013. Abebe Demissie, Regional Coordinator, Eastern Africa Plant Genetic Resources Network, personal communication, Entebbe, 15/16 February 2011. That makes less than 25 per cent of the current 127 contracting parties (by October 2012 and according to document IT/GB-4/11/12, http://www. planttreaty.org/sites/default/files/gb4w12e.pdf, viewed 25 October 2012. According to Halewood et al. (2013, p.17), the limitation of the pool’s effectiveness is exacerbated by the failure of the GB to endorse or create a global information system for facilitation of exchange of information as envisaged by Article 17 of the Treaty. See Santilli (2012: fn 47, p. 123ff.). For the controversies prior to the International Undertaking, see Santilli (2012: 110ff.). Ibid, p. 135. According to Halewood et al. (2013, p. 16), this was an important strategy for developing countries to maintain control over access to a wider set of biological and genetic resources, including farmers’ varieties, wild relatives, etc. See http://www.planttreaty.org/sites/default/files/gb4w13e.pdf, viewed 22 January 2013. Personal communication, anonymous. Jorge Cabrera Medaglia, personal communication, Hyderebad, India, 10 October 2012. Chiarolla and Jungcurt (2011: 25ff.) have proposed two possible options of dealing with the problem: either a ‘radical option’ that seeks to restrict access to ‘free-riding entities’ or a ‘payment option’ that would allow access to the MLS material for such entities, subject to additional contributions to the benefit-sharing fund. The pros and cons of these options are discussed by the authors at p. 26ff. See document IT/AC-SMTA-MLS 2/10/2 (July 2010). ‘The practical and legal implications for natural and legal persons putting material into the multilateral system’, ftp://ftp.fao.org/ag/agp/planttreaty/gb4/AC_SMTA_ MLS2/ac_smta_mls2_w2e.pdf, viewed 17 October 2012. Refusal to facilitate access to material for contracting parties is likely to have a counterproductive effect on the Multilateral System as it might trigger retaliatory reaction with a risk of paralysing it. See also Halewood et al. (eds) (2013, p. 16f.) Crop genetic resources as global commons: challenges in international law and governance, Routledge, London. Ibid. The USA is the second largest supplier of PGRFA samples in the world after the international centres (see Halewood et al. (2013), p. 14) See also Fowler and Hodgkin (2004) who estimate the international distributions of the National Genetic Resources Service (USA) at 16,000 samples of 10 crops per year throughout the 1990s, and another 45,000 samples of domestic distributions annually. FAO (2011) Introduction to the International Treaty on Plant Genetic Resources for Food and Agriculture, figure 4.2, http://www.planttreaty.org/sites/default/files/ edm1_full_en.pdf, viewed 30 October 2012. Also interview, IT Secretariat, Rome, 23/24 May 2011.

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75 IT/GB-4/11/Inf. 5, http://www.planttreaty.org/sites/default/files/gb4i05e. pdf, viewed 22 January 2013. 76 Ibid. 77 Ibid. 78 IT/GB-4/11/Inf. 5, http://www.planttreaty.org/sites/default/files/gb4i05e.pdf, viewed 22 January 2013. 79 In its report to the fourth session of the GB (Bali, Indonesia, 14–18 March 2011), the first meeting of the ad hoc technical advisory committee on the multilateral system and standard material transfer agreement advised that the Secretary establish a separate and dedicated email address on the Treaty website to which SMTA users can send full copies of SMTAs, in order to give the GB a full overview of the use of SMTAs in different regions and to enable users to fulfil reporting requirements of the SMTA. They also advised that the Secretary finish the work on the IT support tools for SMTA operations in order to facilitate the use of the SMTA and SMTA reporting. See IT/GB-4/11/ Inf. 7, http://www.planttreaty.org/sites/default/files/gb4i07e.pdf, viewed 22 January 2013. 80 IT/GB-4/11/Inf. 5, http://www.planttreaty.org/sites/default/files/gb4i05e. pdf, viewed 22 January 2013. 81 Interview, IT Secretariat, Rome, 23/24 May 2011. See also the booklet on funding strategy (especially ‘selection criteria’, p. 15ff.), ftp://ftp.fao.org/ag/ agp/planttreaty/publi/funding_strategy_compilation_en.pdf, viewed 18 October 2012. 82 Marie Schloen, personal communication, Bremen, 3 April 2012. 83 Interview, IT Secretariat, Rome, 23/24 May 2011. 84 See Chapter 18. 85 Abebe Demissie, personal communication, 14/16 February 2011, Entebbe, Uganda. 86 Ibid. 87 Marie Schloen, personal communication, Bremen, 3 April 2012. See also IT/ GB-3/09/13, ftp://ftp.fao.org/ag/agp/planttreaty/gb3/gb3repe.pdf, viewed 22 January 2013. 88 Ibid. 89 IT/GB-3/09/13, ftp://ftp.fao.org/ag/agp/planttreaty/gb3/gb3repe.pdf, viewed 22 January 2013. 90 According to Den Hurk (2011), as quoted in Santilli (2012: 140), the seed industry for example is of the view that cells, organelles (specialized subunits within cells that have specific functions), genes, or molecular constructs isolated from the material may be patented as long as the patentability criteria are fulfilled. 91 Disputes over the practical implementation of the MLS, especially of its benefit-sharing component, are not foreign to the GB and have been brought before its session. See report of its third session (1–5 June 2009, Tunis, Tunisia), IT/GB-3/09/13), ftp://ftp.fao.org/ag/agp/planttreaty/gb3/gb3repe. pdf, viewed 22 January 2013.

Bibliography Chiarolla, C and Jungcurt, S (March 2011) ‘Outstanding issues on access and benefit sharing under the multilateral system of the International Treaty on Plant Genetic Resources for Food and Agriculture’, Background study paper, Berne Declaration and Development Fund, http://www.evb.ch/cm_data/ ITPGR_ABS_Study_1.pdf, viewed 22 January 2013.

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Correa, CM (November 2006) ‘Plant genetic resources under the management and control of the contracting parties and in the public domain: how rich is the basket of the multilateral system of the International Treaty?’, http://www. planttreaty.org/sites/default/files/public_domain.pdf, viewed 14 August 2012. de Jonge, B (2009) ‘Plants, genes and justice. An inquiry into fair and equitable benefit-sharing’, PhD thesis, Wageningen UR, Wageningen, The Netherlands. FAO (2009) International Treaty on Plant Genetic Resources for Food and Agriculture, Rome. FAO (2011) Introduction to the International Treaty on Plant Genetic Resources for Food and Agriculture, Rome. Fowler, C and Hodgkin, T (2004) ‘Plant genetic resources for food and agriculture: Assessing global availability, Annual Review of Environment and Resources, 29, 143–179. Frison C, López F and Esquinas-Alcázar J (2011) Plant genetic resources and food security. Stakeholder perspectives on the International Treaty on Plant Genetic Resources for Food and Agriculture, Earthscan, London. Halewood, M, Noriega, L and Louafi, S (eds) (2013) Crop genetic resources as global commons: challenges in international law and governance, Routledge, London. Hammond, E (2011) ‘How US sorghum seed distributions undermine the FAO Plant Treaty’s multilateral system. Overlap and use of the CGIAR and US sorghum genebank collections’, African Center for Biosafety, Berne Declaration, Development Fund, Melville, Zurich, Oslo, http://www.itpgrfa. net/International/sites/default/files/US_sorghum.pdf, viewed 26 March 2012. IT/GB-3/09 (June 2009) ‘Report of the governing body of the International Treaty on Plant Genetic Resources for Food and Agriculture’, ftp://ftp.fao.org/ ag/agp/planttreaty/gb3/gb3repe.pdf, viewed 9 January 2013. IT/GB-4/11/12 (January 2011) ‘Report of the implementation of the multilateral system of access and benefit sharing’, http://www.planttreaty.org/content/gb4, viewed 17 October 2012. IT/GB-4/11/13 (January 2011) ‘Reviews and assessments under the multilateral system, and of the implementation and operation of the standard material transfer agreement’, http://www.planttreaty.org/sites/default/files/gb4w13e. pdf, viewed 17 October 2012. Kamau, EC (April 2011) The multilateral system of the FAO treaty: ABS lessons for genetic diversity of global importance, IT visual library, http://www.planttreaty.org/ virtual_library, viewed 3 August 2012. Santilli, J (2009) ‘Brazil’s experience in implementing its ABS regime – suggestions for reform and the relationship with the International Treaty on Plant Genetic Resources for Food and Agriculture’, in Kamau, EC and Winter, G (eds) Genetic resources, traditional knowledge and the law. Solutions for access and benefit sharing, London, Earthscan, pp. 187–201. Santilli, J (2012) Agrobiodiversity and the law. Regulating genetic resources, food security and cultural diversity, Earthscan, London. ten Kate, K and Liard, S (1999) The commercial use of biodiversity. Access to genetic resources and benefit sharing, Sterling, Earthscan, London. Visser, B and Borring, J (2011) ‘The European regional group: Europe’s role and positions during the negotiations and early implementation of the International Treaty on Plant Genetic Resources for Food and Agriculture’, in Frison, C, López, F and Esquinas-Alcázar, JT, Plant genetic resources and food

372 Evanson Chege Kamau security. Stakeholder perspectives on the International Treaty on Plant Genetic Resources for Food and Agriculture, Earthscan, London, pp. 69–80, http://biogov.uclouvain. be/staff/frison/ES_PGRFS_print-13July2011.pdf Winter, G (2009) ‘Towards common pools of genetic resources’, in Kamau, EC and Winter, G (eds), Genetic resources, traditional knowledge and the law. Solutions for access and benefit sharing, Earthscan, London, pp. 19–35.

18 Exploring bases for building common pools in eastern Africa1 Evanson Chege Kamau

The transboundary nature of plant genetic resources in the eastern Africa region The countries of eastern Africa (Burundi, Democratic Republic of Congo, Djibouti, Eritrea, Ethiopia, Kenya, Rwanda, Somalia, Sudan and Uganda) and the Indian Ocean Islands (Comoros, Madagascar, Mauritius and Seychelles) are endowed with a great wealth of plant genetic resources and biodiversity. This makes the eastern Africa region one of the world’s most important biodiversity sites. Its heterogeneous environmental conditions and the diverse cultural history of the people make the region an important primary and secondary gene centre for many cultivated species, serving as an economically and ecologically important source of germplasm. It is one of the world’s regions where crop plants were originally domesticated from wild species. Crops originally domesticated outside of the eastern Africa highlands exhibit extreme secondary diversification in eastern Africa. Numerous useful genetic variations of global significance have emanated at the local farm and farm community level. The eastern Africa region is a host to a wide range of important rare and/or endemic species, habitats and ecosystems. The highlands of Ethiopia and Eritrea, the forests of Burundi, Rwanda, Uganda and Kenya are considered as biodiversity hotspots. The alkaline lakes of east Africa – Bogoria, Magadi, Nakuru, Elementaita and Solai in Kenya, and Natron in Tanzania – located on the bed of the Great Rift Valley are rich in extremophile microorganisms, which have been used to manufacture commercial products by industries in the north, namely tide bleach detergent and ‘stonewashing’ material (Kamau 2009: fn. 43). The Ethiopia/Eritrea region is a centre of origin and diversity of important crops such as coffee, barley and finger millet, which are not only useful in the region but also in the rest of the world. Countries of the Great Lakes (Uganda, Rwanda, Burundi) have the easternmost extensions of the rich diversity of the Congolian Tropical Rain Forest while the expansive Somali–Maasai savanna and steppe is the centre of origin and diversity of

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important species of grasses. Endemism is high in the region. The forests of Madagascar, for example, are very rich in the diversity of plant species with high levels of endemism. Generally, Madagascar is very rich in the number of endemic species: 40 per cent of plant species are said to be endemic.2 Several eastern African countries have a wide collection of genetic resources including cereals, legumes, oil crops and forage species (see Table 18.1). Some of the plant species of high pharmaceutical value include prunus africana, aloe spp., warbugia ugandensis, iboza riparia and fagara macrophilla. Countries in the region share a lot of the flora and fauna of the common ecosystems. Some plant species and communities spread across the borders, that is, they are transboundary. Table 18.1, for example, shows that all listed Annex I plant genetic resources for food and agriculture, that is, plant genetic resources included in the multilateral system of the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA), grow in more than one country of the eastern Africa region. Apart from Annex I crops, there are non-Annex I plant genetic resources that are highly transboundary in the region. A good example is an east African native plant called vernonia galamensis that is discussed below.

Access to genetic resources and benefit sharing in the eastern Africa region Currently, access to genetic resources and benefit sharing in the eastern Africa region follows a twofold approach: bilateral and multilateral. Access and benefit sharing of plant genetic resources on a bilateral approach The Convention on Biological Diversity (CBD) affirms the sovereign rights of states over their genetic resources. Article 15.1 states: ‘Recognizing the sovereign rights of States over their natural resources, the authority to determine access to genetic resources rests with the national governments and is subject to national legislation.’ It means that each state is at liberty to determine the rules of access according to national legislation, including subjecting access to its prior informed consent (PIC) as foreseen in Article 15.5. The state providing genetic resources is entitled to receive part of the benefits that arise from those genetic resources. Article 15.7 therefore requires each party to: take legislative, administrative or policy measures, as appropriate, (…) with the aim of sharing in a fair and equitable way the results of research and development and the benefits arising from the commercial and other utilization of genetic resources with the Contracting Party providing such resources…upon mutually agreed terms.

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In 2010, an international legal instrument to the CBD, the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the Convention on Biological Diversity (Nagoya Protocol) was adopted. The Nagoya Protocol comprises an international regime on access and benefit sharing (ABS). It will come into force upon ratification by 50 states.3 In spite of its numerous innovations, including the establishment of international legal standards in regard to access4 and concretization of measures aimed at enforcing the obligations of users to comply with domestic legislation, MATs and share benefits (e.g. jurisdiction of courts, access to justice, recognition and enforcement of foreign judgements and arbitral awards, etc.), the Nagoya Protocol does not change the bilateral approach of the CBD established upon the authority of the state providing genetic resources to determine access and the user of such resources to share with the state that provided genetic resources the benefits arising from their utilization. This is reaffirmed by the Nagoya Protocol, mainly under Articles 5 and 6. Both the CBD and the Nagoya Protocol consider a provider party of genetic resources to be either the country of origin of such resources or a party that has acquired them in accordance with the CBD (Article 15.3 CBD, Article 6.1 Nagoya Protocol). The first criterion, which is relevant for this chapter, refers to a country that possesses genetic resources in in situ conditions, that is, existing within ecosystems and natural habitats, or, in the case of domesticated or cultivated species, in the surroundings where they have developed their distinctive properties (Article 2 CBD). As long as a state qualifies as a ‘provider’ under this definition, it can provide access to a genetic resource and demand benefits from its utilization without need to consult another state, even if such a state is also a country of origin of the same genetic resource. The end result is that the provider is not necessarily the country of endemic origin but of access. For the eastern Africa region, the bilateral approach implies that, in spite of the transboundary nature or cross-border endemism of a species, it is solely the country from which genetic resources are requested that may determine access. Likewise, the country that provided genetic resources receives the benefits arising from their utilization alone. Access to transboundary and endemic genetic material and benefit sharing: the case of Vernonia galamensis This is demonstrated well by the case of a plant species known as Vernonia galamensis, which is known as ironweed or vernonia by its common English names. It is one of over 1,000 species in genus Vernonia. The species Vernonia galamensis itself, however, has its origin in east Africa (EA) (Baye et al. 2005: 257). It is a source of vernonia oil which is rich in a useful epoxy fatty acid called vernolic acid that is used to manufacture plastic formulations, protective coatings (Perdue et al. 1986: 54), drying agents, 5

376 Evanson Chege Kamau adhesives, paints (Thompson et al. 1994: 185), etc. The epoxidized oil from the plant also has unique medical applications when applied topically on human or animal skin, including the treatment of skin diseases and wounds, and is used in folk medicine (Johri and Singh 1997; McClory and Atkinson 2007), for example, to treat chest pains in Tanzania and stomach pains in Kenya, among other uses (Baye and Oyen 2007). Its use promises great success in the future as a new industrial crop for the following reasons: 1 It has a very high content of vernolic acid in the seed oil (Baye and Becker 2005: 805) estimated at over 74 per cent by Baye et al. (2005: 258). 2 Research has shown that a superior variety of vernonia galamensis with higher oil yield can be developed (Perdue et al. 1986: 67). 3 It has a wide range of industrial uses:6 a company called Ver-Tech International identified over 70 potential uses for the vernonia oil (Baye et al. 2005: 258). 4 It contains a potential replacement for traditional plasticizers and binders, which are likely to become unpopular due to the environmental pollution they cause through smog in the production of paints and plastics (Baye et al. 2005: 257). As the maps in Figures 18.1 and 18.2 show, the wild species spreads further from EA to cover the whole of the eastern Africa region, including Madagascar, parts of South Africa, central Africa and West Africa. Vernonia galamensis was initially considered a weed, growing wildly, and is still considered as such in some parts of the region (Baye and Becker 2005: 809f.). Where its potential has been discovered, however, it is grown as an industrial oilseed (Baye and Becker 2005: 805). Its seed production is poor when grown outside the equatorial region, which provides suitable growing conditions, namely loose, porous soil and long periods of dry conditions (Perdue et al. 1986: 63ff.). Therefore cultivation in other places will not always be economically worthwhile before further research in the breeding of this species to produce varieties that can cope with varying climatic conditions shows positive results has been done (Thompson et al. 1994: 199). Vernonia galamensis grows in most parts of Ethiopia (Gebreselassie 2009: 79). The extremely suitable growing conditions for the species in Ethiopia makes the Ethiopian strains of Vernonia superior to those of the other eastern African countries (Perdue et al. 1986: 64ff.). They have good seed germination, excellent seed retention capacity and a very high oil and vernolic acid content – 40 per cent and 80 per cent respectively (Perdue et al. 1986: 59, 65f.; Thompson et al. 1994: 186). Following an ABS agreement, the Ethiopian Institute of Biodiversity Conservation and Research (IBC), which is the national authority regulating access, and a UK company

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Figure 18.1 Distribution of Vernonia galamensis (source: Baye and Oyen 2007)

Figure 18.2 Regions of Africa (source: http://www.mapcruzin.com/free-africa-maps.htm)

378 Evanson Chege Kamau Vernique BioTech Ltd (Vernique) signed a material transfer agreement on vernonia plant genetic resources in 2005 (Gebreselassie 2009: 79). The agreement foresaw the sharing of both monetary and non-monetary benefits, including intellectual property rights, with Ethiopia (Gebreselassie 2009: 82ff.).7 Ethiopia did not consult other eastern African countries before granting access. Therefore, all the benefits arising from the utilization of the species under this agreement will flow to Ethiopia alone. Again, in line with the CBD bilateral approach, the simple fact that if an organism, whether terrestrial or marine, containing genetic resources were taken from a territory under a state’s jurisdiction, it would be grounds enough to provide that state with the full right to control access and claim a share from the benefits arising from its utilization (Winter 2009: 26).8 By implication, an application to access a specimen of Vernonia galamensis from one of the eastern African countries is to be addressed to that particular country. Therefore, any benefits arising from its utilization are to be shared with the country that provided access to it. Based on the bilateral approach of the CBD, two questions arise in regard to the Ethiopian agreement on access to Vernonia galamensis: 1 How equitable is such an arrangement in a case involving a resource that, due to its transboundary nature, does not, de facto, belong to one country? 2 What impact could such an approach have on the conservation and sustainable use objectives of the CBD? This approach is ‘horizontally’9 inequitable as it excludes other eastern African countries from the process of determining access to a plant species that is native to EA. ‘The simple and adventitious event of access in one provider state is no good reason for that state to entirely control the utilization of and benefit from the genetic material if the same genetic material occurs in other states’ (Winter 2009: 26). This is especially so when the genetic material is endemic to more than one state, or is transboundary. Such an approach is also likely to put the goal of conservation and sustainable use at stake because weak legislation is likely to attract more bioprospectors (what is at times referred to as a ‘race to the bottom’) and hence increase bioprospecting pressure (Winter 2009: 26). The spill-over effects of over-exploitation of a transboundary species in the territory of one country has the capacity to affect the same species across the borders. The control of utilization of genetic resources and benefit sharing by a single state therefore has another disadvantage. One provider state will face extreme constraints in trying to oversee the downstream valorization process (Winter 2009: 25ff.; Winter and Kamau 2011: 394f.), that is, the value added process through research and development that mainly takes place in industrialized countries. This results in ‘vertical inequity’10 as the sharing of benefits from utilization of genetic resources by users is likely to fail.

Bases for building common pools in Eastern Africa 379 Access and benefit sharing of plant genetic resources on a multilateral approach In 2001, a multilateral instrument was adopted that specializes in plant genetic resources for food and agriculture, that is, the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA). The ITPGRFA established a multilateral system of ABS that focuses on the 60 most important crops for food security for all humankind. The list of crops is found in Annex I of the ITPGRFA, making them become known as Annex I crops. Details of how ABS of Annex I crops takes place under the multilateral system are discussed in depth in Chapter 17. Briefly, this is how the multilateral system works: •

• •

•

•

All Parties to the ITPGRFA are obliged to notify the Secretariat of the ITPGRFA about Annex I plant genetic resources for food and agriculture (PGRFA) under their management and control or jurisdiction and in the public domain,11 as well as the information or passport data12 related to those PGRFA that are stored in their gene banks. The Secretariat makes the information available on the website of the IT.13 Any (natural or legal) person under the jurisdiction of a contracting party may make a request for access using a standard material transfer agreement (SMTA). Requests are addressed to the Party holding the material, and the transfer is made according to the terms and conditions of an SMTA. These include the obligation of the provider to grant expeditious access. This also waives the need to track individual accessions in provider states. Benefits are not shared directly with the provider country but are deposited into the benefit sharing fund of the multilateral system and shared according to the criterion of need.

The eastern Africa region, as already mentioned, shares many plant genetic resources, some of which are endemic in the region. These include Annex I crops, the most important being those listed in Table 18.1. All countries in the eastern Africa region are parties to the ITPGRFA (see Table 18.2). Access to PGRFA listed under Annex I of the ITPGRFA from the region follows the multilateral approach established by the ITPGRFA. Accordingly, a request for access to and transfer of the PGRFA is done using the SMTA. There is no need for prior consultation between countries, even where the request involves a transboundary species, or a species that is endemic in a number of countries in the region – access has to be granted expeditiously. Hence, even for shared Annex I crops, access to plant genetic resources follows a bilateral approach.

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Table 18.1 Some Annex I crops of great importance to the region Priority Crop/species Hosting no. countries

Information on origin/centre of diversity/endemism

1

Sorghum

All

Domesticated from wild sorghum (S. arundinaceum) in the north-eastern quarter of Africa. The main area of variation of the crop lies in eastern central Africa

2

Finger millet

All

Thought to have originated from Uganda and neighbouring Ethiopian highlands, where tremendous diversity exists. Grown abundantly in upland areas of rift valley: Kenya, Uganda, Rwanda, Burundi. Wild finger millet (subsp. africana) is native to Africa

3

Pearl millet

Ethiopia, Eritrea, Kenya, Sudan

Pearl millet has a diffuse belt of origin extending from West Sudan to Senegal

4

Wheat

Ethiopia, Eritrea

Ethiopia is the secondary centre of diversity for durum wheat. Six known species have been recorded from the region

5

Banana

All

African bananas are grouped into three categories, including East African (mainly dessert) bananas, the African plantain bananas grown mainly in central and West Africa, and the East African Highland Banana, used for cooking and in beer preparation. The highlands of east Africa are an important centre of diversity of cooking bananas

6

Sweet potato

Africa represents a unique secondary site of Burundi, genetic diversity for sweet potato Kenya, Madagascar, Rwanda, Sudan Uganda

7

Rice

Wadi rice (Oryza punctata) is indigenous to Burundi, eastern Africa. Other wild species indigenous Ethiopia, to eastern Africa include O. longestaminata Kenya, Madagascar, Rwanda, Sudan, Uganda

8

Yam

Kenya, Rwanda, Sudan, Uganda

Yams are cultivated throughout tropical Africa. There are at least 13 species occurring in the region. Among the cultivated species, D. bulbifera and D. minutiflora are native to East Africa. Other species of edible yams cultivated in East Africa are introduced and include D. cayenensis (yellow Guinea yam) from West Africa and D. alata (white yam) from Asia

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Table 18.1 continued Priority Crop/species Hosting no. countries

Information on origin/centre of diversity/endemism

9

Cowpea

Ethiopia, Eritrea, Kenya, Rwanda, Sudan, Uganda

North-eastern Africa was proposed as the centre of domestication as high levels of diversity are found in the cultivated and wild cowpeas. It is a broadly adapted and highly variable crop, cultivated around the world

10

Pigeonpea

Kenya, Uganda, Sudan, Ethiopia

Popular crop in the warm semi-arid and sub-humid tropics of eastern Africa

11

Barley

Ethiopia, Eritrea

Ethiopia is the secondary centre of diversity for barley

12

Brassica spp.

Ethiopia, Eritrea

Brassica carinata (Ethiopian mustard) originated in Ethiopia where it is used both as a leaf vegetable and as an oilseed

13

Faba bean

Ethiopia, Most important pulse in Ethiopia Eritrea, Madagascar, Sudan

14

Maize

All

Principal food staple in eastern Africa. Ranks first in Ethiopia in total production and yield per hectare, and is the most important food crop grown and consumed in Kenya

15

Phaseolus

Burundi, Kenya, Madagascar, Rwanda, Sudan, Uganda

Main areas of cultivation: cool highlands of Kenya, Uganda, Tanzania, Rwanda and Burundi, and the warmer mid-elevation areas of Ethiopia

16

Chickpea

Sudan, Eritrea, Ethiopia, Kenya

Ancient crop in Ethiopia and considerable diversity can be found

17

Pea

Ethiopia, Rwanda

Old crop in Ethiopia. Unique subspecies (subsp. abyssinicum) developed in Ethiopia

18

Forages

Kenya, Ethiopia, Sudan, Eritrea

The Somali–Massai savanna and steppe are the centre of origin and diversity for forage species included in Annex I of ITPGRFA

Source: Based on Demissie 2006

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Table 18.2 Status of signature/ratification/accession of the ITPGRFA in the eastern Africa region Country

Signature

Ratification

Burundi

10 June 2002

28 April 2006

Accession

DR Congo

5 June 2003

Djibouti

8 May 2003

Eritrea

10 June 2002

10 June 2002

Ethiopia

12 June 2002

18 June 2003

Kenya

27 May 2003

Madagascar Rwanda

14 October 2010

Sudan Tanzania

30 April 2004

Uganda

25 March 2003

Rethinking access and benefit sharing in the eastern Africa region As demonstrated above, the eastern Africa region has much in common in terms of shared resources. It also implies that the region shares the threats to those resources. There is, therefore, a genuine need and urgency to foster and intensify interstate cooperation in the management of natural resources in the region. In regard to genetic resources it would include cooperation in deciding how access to those resources is undertaken as well as sharing the benefits that arise from their utilization. Such cooperation may also include the sharing of information on accessing ‘regional’ genetic resources under the multilateral system, and joint applications for funds for conservation and sustainable-use activities in the region from the benefit-sharing fund of the multilateral system. The bilateral approach of the CBD never hindered such cross-border or regional cooperation. In fact, Winter (2009: 27) interprets Article 15.1 CBD in regard to the use of the term ‘their’ – ‘Recognizing the sovereign rights of States over their natural resources’ (emphasis added) – as an indication that a resource can be property belonging to several states where the resource does not have a genuine and exclusive link to the territory of a single country. That would imply that such a resource is either a common good, for instance, genetic resources located in the high seas, or is common to a region (Winter 2009: 27). The exploitation or

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conservation of such a resource would thus demand the engagement of several states. Whether connected to this interpretation and reasoning or not, the notion presented by Winter is now very evident in the Nagoya Protocol. Whereas it does not abandon bilateralism as reaffirmed under Article 6.1, which subjects access to the prior informed consent of the party providing genetic resources, it opens up the possibility of multilateralism and regional cooperation under Articles 10 and Article 11 respectively. The Nagoya Protocol is the international legal instrument implementing the third objective of the CBD, that is: the fair and equitable sharing of the benefits arising out of the utilization of genetic resources, including by appropriate access to genetic resources and by appropriate transfer of relevant technologies, taking into account all rights over those resources and to technologies, and by appropriate funding. (Article 1) It was adopted on 29 October 2010 in Nagoya, Japan. It is important to mention at this point that the Nagoya Protocol does not abandon the bilateral approach of the CBD. In regard to transboundary situations and situations where it is impossible to obtain prior informed consent, however, it addresses pragmatically the conceptual and practical difficulties and challenges involved. Under Article 10, the Protocol anticipates the need for a global multilateral benefit sharing mechanism in regard to both situations. Under Article 11, transboundary situations are addressed in view of building interstate cooperation where genetic resources and/or traditional knowledge associated with genetic resources are transboundary. We shall only look at Article 11 as it is more in line with our focus. As mentioned, the Nagoya Protocol anticipates the need for interstate cooperation in Article 11, which it refers to as transboundary cooperation. It states that: 1

2

In instances where the same genetic resources are found in situ within the territory of more than one Party, those Parties shall endeavour to cooperate, as appropriate, with the involvement of indigenous and local communities concerned, where applicable, with a view to implementing this Protocol. Where the same traditional knowledge associated with genetic resources is shared by one or more indigenous and local communities in several Parties, those Parties shall endeavour to cooperate, as appropriate, with the involvement of the indigenous and local communities concerned, with a view to implementing the objective of this Protocol.

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In brief, Article 11 advocates regional cooperation. As already mentioned, regionalism has the capacity to enhance both horizontal and vertical equity. For the organization of cooperation in ABS in the eastern Africa region, we propose two possible approaches. One approach would be to upgrade the Eastern Africa Plant Genetic Resources Network (EAPGREN), whose activities are currently limited to plant genetic resources conservation and sustainable use activities. The second approach would be to have the East African Community (EAC) take up the mandate.

Eastern Africa Plant Genetic Resources Network (EAPGREN) EAPGREN is a regional joint project of National Agricultural Research Systems (NARS) of the Association for Strengthening Agricultural Research in Eastern and Central Africa (ASARECA). Its membership comprises eight countries of the region: Burundi, Eritrea, Ethiopia, Kenya, Madagascar, Rwanda, Sudan and Uganda. Each of these countries has a national focal institution or point for the network and implementation of network related activities at the country level. Background information on formation Traces of initiatives leading to the formation of the network date back to the 1990s, or even slightly earlier, when a number of national plant genetic resources (PGR) programmes were set up in the region.14 These programmes aimed to mobilize resources and networking for more effective PGR activities but did not go far enough to ensure that plant genetic resources of the whole region would be sustainably managed and utilized in the distant future (Kamau 2004: 1).15 This gap which existed in terms of lack of sub-regional networks able to facilitate PGR activities in the region was one of the major motivating factors that led to recommendations during several regional meetings to establish a PGR network in the region. This could strengthen capacity and promote subregional collaboration and synergy.16 Following these recommendations the International Plant Genetic Resources Institute (IPGRI), now called Bioversity International, and the National Agricultural Research Organization (NARO) of Uganda convened a stakeholder meeting in Kampala, Uganda, from 3 to 5 November 1997, to consider the needs and plans for the establishment of a network for the eastern Africa region (Kamau 2004: 1).17 A resolution was made at this meeting by country representatives to establish EAPGREN, which initially had seven participating countries,18 and to ask ASARECA to have EAPGREN operate under its umbrella.19 EAPGREN became operational under the umbrella of ASARECA in May 2003.20

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Objectives The network aims to promote the sub-regional collaboration and networking through the exchange of information and material, research and development, capacity building, adoption of common approaches and methods, and regional integration in PGR activities, 21 with the goal of enhancing effective conservation and utilization of PGR and promoting the use and sharing of benefits arising out of their use in the region and beyond.22 It also aims to ensure that all countries in the sub-region fully benefit from the active crop-based and thematic regional and international networks.23 Organizational structure EAPGREN has a simple organizational structure consisting of a steering committee (SC), coordinating unit (CU) and thematic working groups (WG). STEERING COMMITTEE

The SC is made up of leading experts of national focal institutions/points of the participating countries. In order to fill identified technical gaps, additional members of the committee may be co-opted as necessary. The committee has a secretary who is the coordinator of the CU and a chairman elected annually by the members of the committee. The SC oversees the development of budgets and work plans and provides overall technical guidance in the implementation of the network activities. COORDINATING UNIT

The CU is hosted by one of the NARS to ensure ownership and sustainability at an early stage. It liaises with the technical backstopping institutions, ASARECA, NARS and other collaborating institutions to ensure the smooth and efficient achievement of the network’s objectives and outputs. It is headed by a coordinator who reports to the SC and is responsible for the overall coordination of project activities. THEMATIC WORKING GROUPS

WG – each comprising five to ten experts from NARS, IARCs, nongovernmental organizations (NGOs), the private sector, United Nations agencies, universities, crop networks and regional programmes – are established by the SC and their functions overseen by the CU.24 They are intended to create the opportunity for a wide range of stakeholders to make specific contributions in their area of expertise, serve as a means for

386 Evanson Chege Kamau review and maintenance of scientific standards on a thematic basis, and promote collaboration in order to foster complementarity and avoid unnecessary duplication.25 WG are established according to thematic issues dealt with by the network. These include ex situ conservation, in situ conservation, utilization, information and documentation, and policy and public awareness.26 Each WG is responsible for synthesizing issues related to the theme of its expertise, developing research project proposals and making recommendations for consideration by the SC.27 Such recommendations form the basis for scientific standards and priority setting of regional activities.28 Current activities of the EAPGREN The primary functions of the network are to enhance capacity building for PGR in situ and ex situ conservation and sustainable use; capacity building in providing trainings, both short- and long-term, for scientists, PGR communities, farmers, etc. Any data generated in the conservation process at the collecting sites, during laboratory work, field work, etc., as well as through the process of characterization and evaluation, is stored in e-media. On top of the human development interventions, EAPGREN also enhances infrastructure development targeting national institutions undertaking PGR conservation in the region. It provides equipment for conservation and sustainable use, facilities for characterization and evaluation, both at field and laboratory levels29 and enhances policy formulation and development. The network has three intervention areas: 1) capacity building – human and infrastructure; 2) policy, i.e. support of policy development; 3) PGR services – e.g. information and documentation, and platform developments.

Strengths and setbacks of EAPGREN in organizing a regional pool EAPGREN has a number of strengths that the eastern African countries can bank on in building a regional pool but also suffers from some setbacks. Its strengths are demonstrated by the fact that: •

•

The network’s activities cover a bigger territory than the EAC; thus there are more countries involved. The current number of members of the network is eight countries. The network has long experience of interaction with the members’ PGR-relevant institutions and farmers that would be useful for the organization of such a common pool.

Bases for building common pools in Eastern Africa •

387

The network is in the process of developing a regional PGR information and documentation hub at its headquarters – especially for IT Annex I crops – by having every member country provide collection, characterization, evaluation data, etc. (in general all scientific data) as well as harmonizing the varying PGR information documentation database management systems. These can be extended to cover all genetic resources.

One of the major setbacks is that EAPGREN does not have a mandate to manage such a pool: its primary functions are to enhance capacity building for PGR conservation and sustainable use through the short- and long-term training of scientists, PGR communities, farmers, etc. Another impediment is that, although it coordinates the conservation and sustainable use activities of national programmes, it does not have the mandate to coordinate their ABS activities; each national programme does so bilaterally. Concerning these challenges, the current mandate of the network can be extended to cover other genetic resources and ABS activities. Apart from the mentioned challenges, however, the coordinating unit of the network is under-staffed and only consists of a coordinator and an assistant. It will, therefore, take a great effort to increase its capacity to coordinate ABS activities in the region. Although not a very serious challenge to deal with, Tanzania, which is an important EA country, is not a member of EAPGREN. There is no serious reason for that, save that Tanzania belongs to another regional PGR network, SADC.30

East African Community The East African Community (EAC/the Community) is a regional intergovernmental organization of five eastern African countries: Kenya, Uganda, Tanzania, Rwanda and Burundi. It is based on a pre-existing organization of the former three countries possessing the same name. That organization was established in 1967 by the Treaty for East African Cooperation and came into existence on 1 December of the same year (Hazlewood 1979: 40). Hazlewood (1979: 40) associates its demise in 1977 with, inter alia, Kenya’s setting up of its own airline and Tanzania’s border closure with Kenya. It has also been said that the collapse of the initial EAC was based on the perceived inequality in the distribution of benefits, ideological differences, and differences in the levels of development and lack of political will to solve real or imagined problems (MA Consulting Group 2007). The EAC was re-established by the Treaty for the Establishment of the East African Community (the EAC Treaty/the Treaty) that was signed on 30 November 1999 by the original three partner states – Kenya, Uganda and Tanzania. It came into force on 7 July 2000 following its ratification.31 Following the accession of the EAC Treaty by Rwanda and Burundi on 18

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June 2007, the two countries also became full members of the Community32 with effect from 1 July 2007. The headquarters of the EAC are located in Arusha, Tanzania. Aims and objectives The EAC aims at widening and deepening cooperation among the partner states in, among others, political, economic and social fields for their mutual benefit.33 To this extent, the EAC countries established a Customs Union in 2005 and a Common Market in 2010.34 The next phase of integration will see the bloc enter into a Monetary Union and ultimately become a Political Federation of the East African States.35 Organizational structure The EAC consists of seven organs and six institutions (EAC 1999). The following are the organs of the Community with brief information on their composition and functions according to the Treaty: 1 Summit: made up of the heads of state or government (Article 10.1) and gives general directions and impetus to the development and achievement of the objectives of the Community (Article 11.1). According to Article 9(h), the Summit also has the mandate to establish more organs. 2 Council of Ministers: consists of Partner States’ ministers responsible for EAC affairs plus the Attorney General of each Partner State (Article 13). It is the policy organ of the Community (Article 14.1) and oversees the implementation of Community programmes and ensures the proper functioning and development of the Community in accordance with the Treaty (Article 14.2). ‘[T]he regulations, directives and decisions of the Council taken or given in pursuance of the provisions of this Treaty shall be binding on the Partner States, on all organs and institutions of the Community other than the Summit, the Court and the Assembly within their jurisdictions, and on those to whom they may under this Treaty be addressed’ (Article 16). 3 Coordination Committee: made up of Community permanent secretaries (PS) responsible for EAC affairs and other PS determined by any Partner State (Article 17). It submits reports and recommendations to the Council on the implementation of the Treaty (Article 18(a)) and implements the decisions of the Council as the Council may direct (Article 18(b)). It also receives and considers the reports of the Sectoral Committees and coordinates their activities (Article 18(c)) and may request a Sectoral Committee to investigate any particular matter Article 18(d).

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4 Sectoral Committees: The establishment, composition and functions of a Sectoral Committee are recommended to the Council by the Coordination Committee as may be necessity for the achievement of the objectives of the Treaty (Article 20). Each Sectoral Committee is responsible for the preparation of a comprehensive implementation programme as well as setting out priorities with respect to its sector (Article 21(a)). It also monitors and keeps under constant review the implementation of the programmes of the Community with respect to its sector (Article 21(b)). In addition it submits, from time to time, reports and recommendations to the Coordination Committee either on its own initiative or upon the request of the Coordination Committee concerning the implementation of the provisions of the Treaty that affect its sector (Article 21(c)). 5 East African Court of Justice: consists of a First Instance Division with jurisdiction to hear and determine cases subject to a right of appeal and an Appellate Division which determines cases of First Instance Division appealed to it (Article 23.2, 3). The judges of the Court are appointed by the Summit (Article 24.1). The Court is the judicial body which ensures the adherence to law in the interpretation and application of and compliance with the Treaty (Article 23.1), having initial jurisdiction over the interpretation and application of the Treaty (Article 27). 6 East African Legislative Assembly: comprises nine members elected by each Partner State and ex-officio members (Article 48). It is the legislative body of the Community (Article 49). 7 The Secretariat: is the executive organ of the Community comprising the following offices: Secretary General, Deputy Secretaries General, Counsel to the Community and other offices deemed necessary by the Council (Article 66). As mentioned, the EAC also possesses a number of institutions which seem to follow specific thematic areas. These are: Lake Victoria Basin Commission (LVBC), Civil Aviation Safety and Security Oversight Agency (CASSOA), Lake Victoria Fisheries Organization (LVFO), Inter-University Council for East Africa (IUCEA) and East African Development Bank (EADB). Legal basis for common pools in ABS The Community documents depict a strong will for cooperation, not only among East African Community members, but also with other countries in the region, which creates a good basis for building common pools for ABS purposes.

390 Evanson Chege Kamau Bases for common pools in the EAC THE EAC TREATY

Under Article 5(c), the Treaty lists one of the objectives of the Community as ‘the promotion of sustainable utilization of the natural resources of the Partner States and the taking of measures that would effectively protect the natural environment of the Partner States.’ Although this provision does not explicitly address ABS, it lays the foundation for corporate management of the natural resources of EAC member states. This would include how those resources are exploited/used and would incorporate control of access. In addition, Articles 6(e) and 6(f) list equitable distribution of benefits and cooperation for mutual benefit, respectively, among fundamental principles of the Community. This theme is taken up by the Treaty in more detail in Chapter 19, where concrete measures for cooperation in environmental and natural resources management are defined. Article 111(a) states that the Partner States ‘agree to take concerted measures to foster cooperation in the joint and efficient management and sustainable utilisation of natural resources.’ Among the measures listed are: • •

• •

•

coordination of policies and actions (Article 111(b)); prior and timely mutual notification and information on natural and human activities that may or are likely to have significant transboundary environmental impact, as well as early mutual consultation (Article 111(d)); development of a common environmental management policy (Article 112.1(a)); harmonization of EAC states’ policies and regulations for the sustainable and integrated management of shared natural resources and ecosystems (Article 112.2(j)); and adoption of common policies for conservation of biodiversity and common regulations for access to, management and equitable utilization of genetic resources (Article 112.2(n)).

These and other measures contained in the EAC Treaty serve as good bases for corporate control by the Community Member States on access to genetic resources and the equitable sharing of benefits that arise from the utilization of genetic resources and traditional knowledge associated with genetic resources. In addition, under Article 151.1, the Treaty gives powers to the Partner States to ‘conclude such Protocols as may be necessary in each area of cooperation which shall spell out the objectives and scope of, and institutional mechanisms for cooperation and integration.’ Acting upon these powers, the Partner States concluded the Protocol on Environment and Natural Resources Management, which concretizes the Treaty provisions on environmental and natural resources management.

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PROTOCOL ON ENVIRONMENT AND NATURAL RESOURCES MANAGEMENT

The Protocol on Environment and Natural Resources Management (Protocol) was signed by the Partner States on 3 April 2006 (EAC 2009). It will come into force upon ratification and deposit of instruments of ratification by all the Partner States (Article 45). An acceding state to the Treaty may become a partner to the Protocol upon the deposit of an instrument of accession (Article 46.1). In case of accession by such a state, the Protocol will enter into force 30 days after the deposit of the instrument of accession (Article 46.2). The Protocol dedicates a whole chapter (Chapter Three) to cooperation in environment and natural resources management. In that chapter of the Protocol, specific areas of utmost interest to this chapter of the book are named, which are ‘Management of Transboundary Resources’, ‘Management of Biological Diversity’ and ‘Management of Genetic Resources’. These areas are covered in Articles 9, 10 and 17 respectively. Article 9 is an obligation for Partner States to develop mechanisms that will ensure sustainable utilization of transboundary ecosystems and jointly develop and adopt harmonized common policies and strategies for sustainable management of transboundary natural resources. Whereas Article 9 only addresses transboundary situations, Article 10 deals with biological resources within the entire Community, that is, both transboundary and non-transboundary. It requires Partner States ‘to develop, harmonise, adopt and implement common policies, laws, strategies, plans and programmes relating to the conservation and use of all forms of biological resources, in the Community’ (Article 10.1). More to the point is the provision in regard to creating a corporate mechanism of ABS in the Community in Article 17, which addresses numerous aspects relevant to the formation of a common pool. These are embedded in a number of obligations: •

•

• • •

to develop and harmonize national policies, laws and programmes regulating access to genetic resources and the equitable sharing of the benefits derived from those resources (Article 17.1); to ensure that access to genetic resources, their derivative products or intangible components, is subject to prior informed consent and mutually agreed terms and to ensure that there is an equitable sharing of the benefits derived from the use of these resources (Article 17.2); to develop a benefit-sharing mechanism for transboundary genetic resources (Article 17.3(a)); to promote research in the use and development of genetic resources (Article 17.3(b)); to develop regulatory mechanisms for trade in genetic resources (Article 17.3(c)).

These obligations, however, will still need to be clarified and specified. Currently, only Article 9 and, partially, Article 10 seem to be moderately

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elaborated in the East African Community Transboundary Ecosystems Management Bill 2010. The bill evades issues focused on access to transboundary genetic resources and benefit sharing as listed under Article 17, limiting itself to management with a narrow view of conservation and sustainable use. Nevertheless, there are a few lessons that can be learned from it for organization of ABS activities. THE EAST AFRICAN COMMUNITY TRANSBOUNDARY ECOSYSTEMS MANAGEMENT BILL 2010

The bill (EAC 2010) was debated and passed by the East African Legislative Assembly on 31 January 2012.36 The next stage involves the submission of the amended copies by the speaker of the assembly to the five heads of states for assent.37 Once all of them assent by signing, the bill will become law38 – the East African Community Transboundary Ecosystems Management Act, 2010. It will come into force on such a date as the Council may, by notice in the Gazette, appoint (Section 1(2)). The object of the bill is to provide a legal framework to effectively streamline the management of transboundary ecosystems (Section 3) with a view to enhancing the quality of the environment and also ensure sustainable utilization of shared natural resources in the Community. The bill establishes a Commission under Section 5(1) (East African Transboundary Ecosystems Management Commission) with the power to manage ecosystems and other related matters in the Community (Section 7). Table 18.3 contains several provisions that are a good basis for organizing a common pool of genetic resources in EA. Bases for common pools in the eastern Africa region The legal instruments analysed above depict the existence of some space upon which a larger common pool beyond the current EAC can be built. The Treaty’s definition of ‘Partner States’ and Article 3.1 are clear that the Community is open for membership of new states. A foreign country may apply to the Partner States for membership and the latter will decide, based on terms they may determine (Article 3.2). Important considerations for membership include potential contribution to the strengthening of integration within the East African region, and geographical proximity to and interdependence between it and the Partner States (Article 3.3(c), (d)), among others. Upon receiving membership to the Community, such a member becomes a Partner State following the definition of Article 3.1 and will become a party to instruments implementing the different areas of cooperation39 upon their ratification. In regard to the Protocol and the bill looked at above, such a development would imply an expansion of cooperation in the management of transboundary resources, including genetic resources. Partner States may even consider either harmonizing or centralizing the management of non-transboundary cases.

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Table 18.3 Provisions providing a basis for construction of an EA common pool Provision

Text

Comments

Section 2

Defines ‘Partner States’ which means the Republic of Burundi, the Republic of Kenya, the Republic of Rwanda, the United Republic of Tanzania and the Republic of Uganda, and any other country granted membership to the Community under Article 3 of the Treaty

The significance of this definition is that it explicitly makes every Community Member State, current and future, subject to obligations laid down in the bill. That is not the case with the Protocol – or at least it is not interpreted that way. Under Article 46 on accession, the Protocol says, in Paragraph 1, that ‘A State that becomes party to the Treaty may become a Partner to this Protocol by depositing an instrument of accession with the depository’ (emphasis added). That means, any country that joined or joins the Community after Kenya, Uganda and Tanzania, the initial members that signed the Treaty in 1999, is not under any strict obligation to become a ‘Partner’ to the Protocol. That has the effect of limiting the geographical scope of the instrument, if the legislation implementing the Protocol does not make participation by all Community members mandatory

Section 2

Defines ‘Party of origin’, meaning ‘the Partner State or Partner States of the Community under whose jurisdiction an existing or a proposed project is planned to take place’

Eliminates competition as to which Partner States belong to the country of origin for shared resources. It also resolves the riddle concerning which Partner State should benefit from utilization of resources that are endemic in the Community

Section 4

This Act shall apply to all existing and proposed activities in transboundary ecosystems within and among Partner States

Although access to genetic resources or bio-prospection is not explicitly mentioned, ‘… all … activities …’ would seemingly embrace such activities as well (emphasis added). This would, in principle, place ABS activities on transboundary resources under the mandate of the EAC

Section 12 Partner States shall require (1) any person intending to use the shared transboundary ecosystems within their respective territories for purposes other than domestic use, or who intends to set up a project in such ecosystems to obtain a permit from the relevant competent authority within the Partner State

Save ensuring that each partner state establishes a permit requirement for use of shared transboundary resources, the provision also ensures mutual recognition of permits issued by a fellow Partner State. In a way, it also harmonizes the permit issuing process for transboundary resources as the user is not subjected to a process requiring a permit from each Partner State sharing the same resource

394 Evanson Chege Kamau Table 18.3 continued Provision

Text

Section 12 The permit shall be (2) granted only after such a Partner State has determined that the proposed project will not have a detrimental effect on the shared transboundary ecosystems

Comments The provision standardizes the requirement to assess the effects of the use of a resource from transboundary ecosystems, placing the responsibility of action on each Partner State on behalf of other states

Places the responsibility of action on Section 12 A Partner State shall, each Partner State on behalf of other (3) within thirty days of becoming aware, notify the states affected Partner State and other States of the Community of any impact originating from its territory Section 12 Every project which, by its (4) nature, size or location, is likely to have significant impact on the transboundary ecosystems shall be subjected to an environmental impact assessment

Harmonizes standards and procedures

Section 13 The activities specified in Harmonizes standards and procedures (1) Schedule 1, which have or are likely to have significant trans-boundary impacts within and among the Partner States of the Community shall be determined by the Commission as activities, which shall not be carried out without an approved environmental impact assessment Section 15 Partner States shall adopt common standards (and procedures) issued by the Council on the recommendation of the Commission

Harmonizes standards and procedures

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The Treaty also creates space for regional cooperation without the need to become a member of the Community. Article 3.2 foresees association of a foreign country with the Community or its participation in any of the activities of the Community. Based on this provision, the Community may establish cooperation, for example, on transboundary resources, which may include access to genetic resources and associated traditional knowledge and benefit sharing.

Which way forward? Based on the above analysis, organizing a common pool of genetic resources under the EAC seems to be the best option for the eastern Africa region.40 The EAC already has structures in place that could be used to organize a common pool of genetic resources which include institutions and legal instruments. As already seen, the Treaty and the instruments implementing it in the relevant area have space for building such a pool both within the current EAC and beyond. In addition, the Community is an intergovernmental organization and therefore a political block and institution with powers to enact binding agreements for its members. Likewise, its institutions have unmatchable financial masse compared to EAPGREN. However, the EAC may consider using EAPGREN as a branch of the Community in ABS activities, including as a coordinator of such activities between its members or as a link between the relevant intergovernmental institutions.

Conclusion The countries of the eastern Africa region share many common ecologies, flora and fauna. Many plant species and communities spread across their borders. It is right to say that such plant species cannot be regarded as the de facto property of one single state. However, the CBD acknowledges the sovereign right of states over their natural resources and, consequently, their authority to determine access to genetic resources. They also have the right to receive a portion of the benefits that arise from utilization of such resources. Practice shows that these rights are interpreted as individual rights of each state. That results in both horizontal and vertical inequity. Such inequity can be overcome by establishing a regional common pool. In spite of the CBD bilateral approach, states are not restrained from establishing such common pools. Indeed, the Nagoya Protocol foresees or recommends cooperation of (neighbouring) states where genetic resources are found in transboundary situations. Legally, such cooperation is already at an advanced stage within the EAC, as the Community has enacted several instruments to cope with transboundary ecosystems challenges, including issues of access to genetic resources and benefit sharing. There are clear signs of an emerging EAC common pool with a potential for expansion in the eastern Africa region.

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Notes 1 A substantial part of this chapter is based on interviews I conducted at the Coordinating Unit of EAPGREN in Entebbe and at NARO (National Agricultural Research Organisation) in Mukono, both in Uganda, on 14/16 February 2011. I would like to thank Dr. Abebe Demissie, Regional Coordinator EAPGREN, and Dr David Hafashimana (NARO) for accepting my request to interview them and for furnishing me with important information and materials, which were instrumental in shaping the study. I would also like to acknowledge EAPGREN for permitting me to use their materials, including applications for funds. The author bears full responsibility for the accuracy of the information, as well as any errors. 2 Abebe Demissie, personal communication, Entebbe, Uganda, 14/16 February 2011. 3 Article 33 Nagoya Protocol. 4 Requirements for PIC, concretizing Article 15.2 of the CBD which requires states ‘to facilitate access to genetic resources for environmentally sound uses by other Contracting Parties and not to impose restrictions that run counter to the objectives of this Convention’. 5 See ‘Alamata pilot learning site diagnosis and program design’ (23 June 2005), http://www.ipms-ethiopia.org/content/files/Documents/PLS-DPD/Alamata. pdf, viewed 11 June 2012. 6 Demissie, personal communication, Entebbe, Uganda, 14/16 February 2011. 7 Ibid. 8 For ABS of marine genetic resources in the high seas, see Chapter 19. 9 For a definition of the term, see Chapter 1. 10 Ibid. 11 Article 11.2 ITPGR. 12 Passport data are detailed information comprising identification, agronomic characteristics, morphological characteristics, organoleptic and technological characteristics, and cultural practices. 13 Through this procedure, the MLS has registered more than 1.3 million collections to date. The list of notified inclusions and a sample letter of notification can be viewed on the Treaty website, http://www.planttreaty.org/ inclusions, viewed 2 August 2012. 14 Demissie, note 1. 15 See also EAPGREN’s website, http://www.asareca.org/eapgren, viewed 2 August 2012. 16 Ibid. Also Demissie, personal communication, Entebbe, Uganda, 14/16 February 2011. 17 See also EAPGREN’s website, http://www.asareca.org/eapgren, viewed 2 August 2012. 18 Rwanda is the only member country of EAPGREN that did not participate from the outset. 19 See EAPGREN’s website, http://www.asareca.org/eapgren, viewed 2 August 2012. 20 Ibid. 21 Ibid. 22 Demissie, personal communication, Entebbe, Uganda, 14/16 February 2011. 23 See EAPGREN’s website, http://www.asareca.org/eapgren, viewed 2 August 2012. 24 Ibid. 25 Ibid. 26 Ibid.

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27 Ibid. 28 Ibid. 29 EAPGREN has provided facilities including computers, cameras and GPS to national partners across EAPGREN member countries. 30 Demissie, personal communication, Entebbe, Uganda, 14/16 February 2011. 31 The Treaty for Establishment of the East African Community was amended on 14 December 2006 and 20 August 2007. 32 According to Article 3 on membership of the Community, the members of the Community are the three initial partner states, Uganda, Kenya and Tanzania, and any other country granted membership to the Community under Article 3. 33 See website of the EAC, http://www.eac.int, viewed 2 August 2012. 34 Ibid. 35 Ibid. 36 http://www.eac.int/index.php?option=com_content&view=article&id=903:billon-transboundary-ecosystems&catid=146:press-releases&Itemid=194, viewed 28 January 2013. 37 Ibid. 38 Ibid. 39 Article 151.1 states that ‘The Partner States shall conclude such Protocols as may be necessary in each area of cooperation which shall spell out the objectives and scope of, and institutional mechanisms for cooperation and integration.’ 40 Similar view, David Hafashimana, personal communication, Mukono, Uganda, 14/16 February 2011.

References IPMS (Improving Productivity and Market Success) Project Team (23 June 2005) ‘Alamata pilot learning site diagnosis and program design’, http://www.ipmsethiopia.org/content/files/Documents/PLS-DPD/Alamata.pdf, viewed 11 June 2012. Baye, T and Becker, HC (2005) ‘Exploration of Vernonia galamensis in Ethiopia, and variation in fatty acid composition of seed oil’, Genetic Resources and Crop Evolution, 52, 805–811. Baye, T, Becker, HC and Witzke-Ehbrecht, SV (2005) ‘Vernonia galamensis, a natural source of epoxy oil: variation in fatty acid composition of seed and leaf lipids’, Industrial Crops and Products, 21, 257–261. Baye, TM and Oyen, LPA (2007) ‘Vernonia galamensis (Cass.) Less’, [Internet] Record from Protabase, Van der Vossen, HAM and Mkamilo, GS (eds), PROTA (Plant Resources of Tropical Africa/Ressources végétales de l’Afrique tropicale), Wageningen, Netherlands, http://database.prota.org/dbtw-wpd/ exec/dbtwpub.dll?AC=QBE_QUERY&BU=http://database.prota.org/search.ht m&TN=PROTAB~1&QB0=AND&QF0=Species+Code&QI0=Vernonia+galame nsis&RF=Webdisplay, viewed 28 January 2013. Demissie, A (2006) ‘Regional strategy for the ex situ conservation of plant genetic resources in Eastern Africa’, http://www.asareca.org/eapgren/pdfs/ EAPGREN%20ex%20situ%20collection%20Strategy%20for%20Website.pdf, viewed 2 August 2012. EAC (1999) Treaty for the Establishment of the East African Community, http:// www.eac.int, viewed 26 June 2012.

398 Evanson Chege Kamau EAC (2010) The East African Community Transboundary Ecosystems Management Bill, http://www.au.int/SP/MEAS/resources/documents/eastafrican- communit y-transboundar y- ecosystems -management-bill-2010 memorandum, viewed 26 June 2012. EAC Secretariat (2009) Protocol on Environment and Natural Resources Management, Arusha, Tanzania, http://www.eac.int, viewed 25 June 2012. Gebreselassie, AT (2009) ‘Material transfer agreements on teff and vernonia – Ethiopian plant genetic resources’, Journal of Politics and Law, 2 (4), 77–89. Hazlewood, A (1979) ‘The end of the East African Community: what are the lessons for regional integration schemes?’, Journal of Common Market Studies, 18 (1), 40–58. Johri, RK and Singh, C (1997) ‘Medicinal uses of Vernonia species’, Journal of Medicinal and Aromatic Plant Sciences, 19, 744–752. Kamau, EC (2009) ‘Facilitating or restraining access to genetic resources? Procedural dimensions in Kenya’, Law, Environment and Development Journal, 5/2, 152–166, http://www.lead-journal.org/content/09152.pdf, viewed 26 January 2013. Kamau, H (2004) ‘Plant genetic resources in Eastern Africa’, Regional status report, EAPGREN/ASARECA/IPGRI. MA Consulting Group (2007) ‘Study on the establishment of an East African community common market: final report’, http://www.eac.int, viewed 25 June 2012. McClory PG and Atkinson A, ‘Use of naturally occurring expodised molecules from Veronia Galamensis’, US Patent 2007/0202207 A1, filed 3 January 2007 and issued on 30 August 2007. Perdue, RE Jr, Carlson, KD and Gilbert, MG (1986) ‘Vernonia galamensis, potential new crop source of epoxy acid’, Economic Botany, 40 (1), 54–68. Thompson, AE, Dierig, DA, Johnson, ER, Dahlquist, GH and Kleiman, R (1994) ‘Germplasm development of Vernonia galamensis as a new industrial oil crop’, Industrial Crops and Products, 3, 185–200. Winter, G (2009) ‘Towards regional common pools of GRs – improving the effectiveness and justice of ABS’, in Kamau, EC and Winter G (eds), Genetic resources, traditional knowledge and the law. Solutions for access and benefit sharing, Earthscan, London, pp. 19–35. Winter, G and Kamau, EC (2011) ‚Von Biopiraterie zu Austausch und Kooperation’, Archiv des Völkerrechts, Band 49, Heft 4, Mohr Siebeck, Tübingen, pp. 373–398.

19 Common pools for marine genetic resources A possible instrument for a future multilateral agreement addressing marine biodiversity in areas beyond national jurisdiction Thomas Greiber Introduction All cellular life comes from the sea. The world’s oceans cover nearly 71 per cent of the Earth’s surface, provide more than 90 per cent of the habitable area for life on Earth, and host an immense biological diversity which still waits to be fully discovered. It is understood that such marine biological diversity provides important goods (including biomass, oil, gas, minerals, bioactive molecules) and services (climate regulation, nutrient regeneration and supply to the photic zone, food) of immense socioeconomic value as well as great importance for the achievement of international development goals (Census of Marine Life 2011: 2). The continued provision of these goods and services depends on the future conservation and sustainable use of marine biodiversity. Indeed, the reduction of biodiversity may be associated with exponential reductions of ecosystem functions: 20–25 per cent of species loss can cause a reduction of 50–80 per cent of ecosystem functions (Cicin-Sain et al. 2008: 3). However, humans are increasingly impacting all aspects of the ocean system in different ways, including through illegal, unreported and unregulated fishing, overfishing, destructive fishing practices, pollution (including ocean acidification), anthropogenic climate change, among others. The exploration and exploitation of marine genetic resources is another human activity which needs to be considered in the context of conservation and sustainable use of marine biological diversity for various reasons. First of all, there is increasing interest from bioprospectors in marine genetic resources, which has led some people to refer to marine genetic resources as ‘blue gold’ (the term ‘green gold’ has sometimes been used to explain the importance of access and benefit sharing related to terrestrial genetic resources under the Convention on Biological Diversity). Second,

400 Thomas Greiber little is known so far about the conservation status of most of the species used as sources for marine genetic resources (Arrieta et al. 2010: 18321). In addition, bioprospecting activities can result in the destruction of habitats, overexploitation of resources, alteration of local hydrological and environmental conditions, different forms of pollution, and also cumulative impacts over time. Third, access to marine genetic resources is only regulated when it takes place within national jurisdiction, but not in areas beyond national jurisdiction (ABNJ). At the same time, sharing benefits from the utilization of marine genetic resources accessed in ABNJ is a critical issue to be considered in the ongoing international discussions about possible ways forward on the conservation and sustainable use of marine biodiversity in ABNJ, including the need for greening the blue economy. This chapter will take a closer look at the issue of access and benefit sharing (ABS) with regard to marine genetic resources originating from a specific part of the oceans, namely the so-called areas beyond national jurisdiction. For this, the peculiarities of marine genetic resources from ABNJ are summarized; the currently existing legal frameworks and political contexts are explained; and the idea of common pools as part of a possible future ABS regime for marine genetic resources from ABNJ is discussed.

Peculiarities of marine genetic resources from areas beyond national jurisdiction While the exploration and exploitation of marine biological diversity was long limited to coastal waters, this is no longer the case today. Due to recent advances in technology, marine scientific researchers as well as commercial enterprises are now increasingly capable of exploring all realms of the oceans, including ABNJ. Marine ABNJ comprise both the high seas, which is the water column beyond 200 nautical miles from the coastal baseline, and the Area, which is the deep seabed and ocean floor, including its subsoil. Such ABNJ cover more than 60 per cent of the surface of the world’s oceans. The fascination of marine biodiversity in ABNJ in general and marine genetic resources from ABNJ in particular is linked to the fact that some of the most surprising discoveries in biodiversity in the past decades have been made here. For example, creatures have been discovered which are perfectly adapted to extreme conditions, including eternal darkness, extreme temperature and high hydrostatic pressure. These so-called extremophiles present interesting metabolic, physiological and taxonomic characteristics which first of all awake an enormous scientific interest in how life emerged on Earth and how it flourishes in such extreme environments (Ruth 2006: 17). Furthermore, there is a great commercial interest in these marine organisms, in particular within the health and

Common pools for marine genetic resources 401 cosmetics sectors, as the ratio of potentially useful natural compounds is higher than in terrestrial organisms, which again increases the probability of commercial success of bioprospecting (Arrieta et al. 2010: 18318, 18320). Such commercial interests are also reflected in the number of patents on marine genetic resources, including resources from ABNJ, which is constantly growing with an estimated yearly growth rate of 12 per cent (Arnaud-Haond et al. 2011: 1521). Finally, it must be recognized that both scientific and commercial exploration of marine genetic resources may serve a greater sociological purpose. Marine genetic resources can provide antioxidant, antiviral, anti-inflammatory, anti-fungal, anti-HIV, antibiotic, anti-cancer, anti-tuberculosis, and anti-malarial strains, which could lead to the development of blockbuster drugs bringing benefits for all human beings (UNGA 2007: 50). Until now, the majority of commercial developments have originated from genetic resources obtained from sedentary species (Leary et al. 2009: 183–194). However, it is important to understand that the focus of oceanographic expeditions is not limited to a certain realm of the oceans. In fact, interesting marine genetic resources can be found in different ecosystems in all three realms of the oceans: the epipelagic realm which is the sunlit open ocean; the mesopelagic and bathypelagic realm which is the midocean water column below 200 metres; and the benthic realm which is the seabed (UNEP 2006: 10). Furthermore, it must be noted that bioprospecting in ABNJ requires sufficient financial and technological resources. The equipment needed for bioprospecting in extreme environments, such as submarines able to reach the seabed in a depth greater than 1,000 metres, is often owned and/or operated by public institutions which may partner with interested private companies for reasons of cost recovery (Arico and Salpin 2005: 23– 24). Consequently, bioprospecting expeditions in ABNJ are currently limited to a small number of countries, and it is often difficult to distinguish between their public or private, as well as scientific or commercial nature. Last but not least, it should not be forgotten that despite possible socioeconomic benefits, the exploration and utilization of marine genetic resources in ABNJ simultaneously poses environmental threats to the unique biodiversity found in these areas. Deep seabed ecosystems, in particular, appear to be sensitive to human activities, as slight disturbances and changes in environmental conditions might have a significant impact on key biological processes and might cause unforeseen damage (CBD 2005: 9). Such disturbances may arise in different ways, including through unsustainable harvesting of biota, drilling activities which might lead to changes in fluid flow pathways, utilization of technological equipment which is placed on and damages fauna and flora, or disturbs photosensitive organisms through light-spots, etc. (Korn et al. 2003: 22). This indicates the fragility of ecosystems as well as their biodiversity in ABNJ.

402 Thomas Greiber

Political context As mentioned at the beginning, ABNJ are subject to multiple pressures that threaten their exceptional biodiversity. In order to study issues relating to the conservation and sustainable use of marine biological diversity beyond areas of national jurisdiction an Ad hoc Open-ended Informal Working Group (BBNJ WG) was established by the United Nations General Assembly (UNGA) through Resolution 59/24 in 2004. At its fourth meeting in May 2011, the BBNJ WG made, amongst others, the following recommendations, which were adopted by the UNGA through Resolution 66/231 in December 2011: (a) A process be initiated, by the General Assembly, with a view to ensuring that the legal framework for the conservation and sustainable use of marine biodiversity in areas beyond national jurisdiction effectively addresses those issues by identifying gaps and ways forward, including through the implementation of existing instruments and the possible development of a multilateral agreement under the United Nations Convention on the Law of the Sea; (b) This process would address the conservation and sustainable use of marine biodiversity in areas beyond national jurisdiction, in particular, together and as a whole, marine genetic resources, including questions on the sharing of benefits, measures such as area-based management tools, including marine protected areas, and environmental impact assessments, capacity-building and the transfer of marine technology. (UNGA 2011a: 29) Consequently, the UN member states have agreed to identify possible gaps in the current legal framework for the conservation and sustainable use of marine biodiversity in ABNJ and to consider the development of a multilateral agreement under the 1982 United Nations Convention on the Law of the Sea (UNCLOS) in order to address these gaps. According to the outcomes of the United Nations Conference on Sustainable Development (Rio+20 Conference), the decision whether to initiate negotiations on such an international instrument under the UNCLOS will be taken before the end of the 69th Session of the UNGA, that is, before the end of the year 2014 (UNCSD 2012: 162). Such a multilateral agreement could be developed in the form of a socalled implementing agreement under the UNCLOS, a procedural option which was already applied twice in order to implement the UNCLOS provisions related to the conservation and management of straddling fish stocks and highly migratory fish stocks (1995 UN Fish Stocks Agreement) and to address certain difficulties with the seabed mining provisions

Common pools for marine genetic resources 403 contained in Part XI UNCLOS (Agreement Relating to the Implementation of Part XI of the Convention). The issue of ABS with regard to marine genetic resources in ABNJ presents a key issue to be discussed in this context, as it is listed in UNGA Resolution 66/231 as one component of a package of tools for the conservation and sustainable use of biodiversity in ABNJ. Furthermore, the Resolution clearly states that benefit sharing related to marine genetic resources in ABNJ will be addressed ‘together and as a whole’ with all other tools. This formulation, which was repeated in the recommendations by the BBNJ WG at its fifth meeting in May 2012, indicates a ‘package deal’ where the agreement on certain conservation tools, such as marine protected areas, will depend on finding an agreement in ABS. It is interesting to note that a similar package deal situation existed at the tenth meeting of the Conference of the Parties to the Convention on Biological Diversity (CBD) where the adoption of the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization (Nagoya Protocol) was made, a condition for the adoption of the Strategic Plan for Biodiversity for the period 2011–2020 and the Strategy for Resource Mobilization in Support of the Achievement of the Convention’s Three Objectives. Two questions arise that are of interest in the present context: do existing legal frameworks cover the issue of ABS related to marine genetic resources in ABNJ? And if not, what could an ABS regime for marine genetic resources in ABNJ look like?

Existing legal frameworks Different international legal instruments currently exist which target the marine environment, its biodiversity and/or the issue of ABS. However, the ownership of marine genetic resources in ABNJ as well as related access and benefit-sharing requirements are not sufficiently regulated by any of them, which will be shown below. The Convention on Biological Diversity and the Nagoya Protocol The CBD introduced the concept of ABS as one of its three objectives, with the main ABS provision set out in Article 15. The Nagoya Protocol provides the instrument for the implementation of the ABS provisions of the CBD (Article 4.4 Phrase 1 Nagoya Protocol). According to Article 3, the Nagoya Protocol applies to genetic resources within the scope of Article 15 CBD and to the benefits arising from their utilization. The wording of Article 3 does not clearly define the geographical scope of the Nagoya Protocol, but refers to the scope of Article 15 CBD. According to Article 4(a) CBD, the jurisdictional scope of the CBD (including Article 15) applies to those components of biological diversity

404 Thomas Greiber which are covered by a state’s national jurisdiction. The UNCLOS regulates that in internal waters (i.e. all waters lying landward of the baseline) and the territorial sea (i.e. a belt of sea adjacent to a coastal state, the breadth of which may not exceed 12 nautical miles measured from its baselines), the coastal state exercises sovereignty over all living and non-living natural resources found in the water column, the seabed and the subsoil thereof. Furthermore, in the exclusive economic zone and the underlying continental shelf (i.e. the water column, seabed and subsoil thereof up to the limit of 200 nautical miles from the baseline), the coastal state holds sovereign rights over the exploitation, conservation and management of living and non-living natural resources, and exercises jurisdiction over marine scientific research. On its extended continental shelf (i.e. the seabed not exceeding 350 nautical miles from the baseline or 100 nautical miles from the 2,500-metre isobaths), the coastal state enjoys sovereign rights only over non-living natural resources found in the seabed and the subsoil thereof, as well as over sedentary species. In contrast, ABNJ, meaning the high seas and the Area, are not subject to any state’s sovereignty. While the living as well as non-living natural resources of the high seas are subject to the freedom of the high seas, which means that they are owned by those who catch them first, all solid, liquid or gaseous mineral resources in situ in the area at or beneath the seabed are the common heritage of mankind, which means that all rights in these resources are vested in mankind as a whole (Article 137.2 UNCLOS). Consequently, Article 15 CBD exclusively applies to those marine genetic resources which are found within the ambit of a costal state’s internal waters, territorial sea and exclusive economic zone with the underlying continental shelf. ABNJ are nevertheless dealt with in Article 4(b) CBD. Accordingly, the CBD also applies to processes and activities taking place in ABNJ, provided that such processes or activities are carried out under the jurisdiction or control of a state. Bioprospecting in marine ABNJ has sometimes been considered an activity carried out under the control of a state (the flag state), which would mean that it falls within the scope of the CBD. However, it should be noted that Article 3 Nagoya Protocol does not refer to Article 4(a) and (b), but explicitly ‘only’ to Article 15 CBD. Article 15 does not expressly exclude genetic resources in ABNJ from its scope. However, by implication, it can be understood as only applying to genetic resources that are subject to national sovereignty, as every paragraph of the Article deals with states exercising their sovereign right to grant access to and providing genetic resources. As states do not have sovereign rights over genetic resources in ABNJ, it can be argued that Article 15 as a whole does not address genetic resources in ABNJ. Furthermore, it has to be noted that the chapeau of Article 4 reads ‘except as otherwise expressly provided in this Convention’. This means that the general rule contained in Article 4(b) only applies provided that no special rule, such as Article 15, exists.

Common pools for marine genetic resources 405 Even if it was argued that ABNJ are in principle within the scope of Article 15 CBD and therefore also within the scope of the Nagoya Protocol, the practicality of such an interpretation is questionable. The ABS regime established by Article 15 CBD and further implemented by the Nagoya Protocol, follows a bilateral approach, which is based on the concepts of prior informed consent (PIC) by the provider, and mutually agreed terms (MAT) between the provider and user of a genetic resource. Before marine genetic resources are collected from ABNJ, there is no state or entity which could grant PIC or negotiate MAT with regard to these resources, so that a bilateral approach is not applicable. Only after marine genetic resources are collected from ABNJ could the flag state, having jurisdiction over the bioprospecting activity, (in theory) grant PIC and negotiate MAT. However, as this state did not have sovereign rights over the resources from the very beginning, it does not appear to be the legitimate ‘representative’ of the resources. Indeed, the situation in ABNJ is not comparable with the one foreseen under Article 15 CBD and the Nagoya Protocol. Instead, such resources could be regulated by an existing international agreement whose exercise of rights and obligations do not cause serious damage or a threat to biological diversity (Article 4.1 Phrase 1 Nagoya Protocol), or by a future international instrument or mechanism which may be developed according to Article 4.2 of the Nagoya Protocol. The United Nations Convention on the Law of the Sea The UNCLOS could be an existing instrument as foreseen under Article 4.1 Phrase 1 Nagoya Protocol. It ‘sets out the legal frameworks within which all activities in the oceans and seas must be carried out and is of strategic importance as the basis for national, regional and global action and cooperation in the marine sector’ (UNGA 2010a: 2) and is therefore sometimes referred to as the ‘constitution for the oceans’. The UNCLOS does not specifically regulate marine genetic resources, including questions of their ownership or ABS. Indeed, the term ‘marine genetic resources’ is neither utilized nor described in its Preamble or operative text. However, different UNCLOS provisions could be interpreted to cover the issue of marine genetic resources in ABNJ, namely the provisions in Part XI UNCLOS on the Area, in Part VII UNCLOS on the high seas, or in Part XIII UNCLOS on marine scientific research. Concerning Part XI on the Area, as mentioned before, all rights in the resources of the Area are vested in mankind as a whole, that is, they shall be explored and exploited for the benefit of mankind as a whole, irrespective of the geographical location of states (Preamble, as well as Articles 137.2 and 140.1 UNCLOS). According to Articles 137.2 and 140.2 UNCLOS, the International Seabed Authority shall act on behalf of mankind as a whole and provide for the equitable sharing of financial and other economic benefits derived from activities in the Area. Furthermore,

406 Thomas Greiber Article 144 UNCLOS promotes and encourages transfer of related technology and scientific knowledge so that all states benefit therefrom. While Part XI UNCLOS thus does establish benefit-sharing rules, their scope is limited in two ways: covering only mineral resources (Article 133(a) UNCLOS) which means non-living resources and therefore excluding marine genetic resources; and covering only resources in situ in the Area at or beneath the seabed, which excludes those resources found in the water column above the seabed. Therefore, all natural resources beyond the reach of the exclusive economic zone and the continental shelf which are not covered by the Part XI regime, including marine genetic resources in the deep seabed as well as the water column above, might fall under the high seas regime of Part VII UNCLOS. Part VII on the high seas applies to ‘all parts of the sea that are not included in the exclusive economic zone, in the territorial sea or in the internal waters of a State, or in the archipelagic waters of an archipelagic State’ (Article 86 UNCLOS). Article 87 provides all states, whether costal or land-locked, with various freedoms of the high seas, including inter alia the freedom of fishing, or the freedom of scientific research (Article 87.1(e) and (f) UNCLOS). As these freedoms are listed ‘inter alia’ they also cover the freedom of access to and use of genetic resources. However, it is important to note that the freedom of the high seas is not absolute in its nature and can be subject to certain requirements, such as: • • •

conservation, management and cooperation obligations with regard to fishing activities (Articles 116–120 UNCLOS); the duty to pay due regard to the interests of other states in their exercise of the freedom of the high seas (Article 87.2 UNCLOS); and conditions for research activities as established in Part XIII and XI UNCLOS which provide for certain non-monetary benefit-sharing rules (see below).

As bioprospecting activities (like fishing activities) may have negative impacts on ecosystems and their biological diversity, and as patenting the results of bioprospecting activities may limit, to a certain degree, research on the same genetic resources in the future (and therefore indirectly the freedom of scientific research), the freedom of access to and use of genetic resources could be further limited. However, no ABS requirements regarding marine genetic resources currently exist in Part VII UNCLOS. Finally, Part XIII UNCLOS on marine scientific research could provide an ABS regime for marine genetic resources in ABNJ, if research was understood as covering pure as well as applied (commercial) research. Indeed, Article 246 UNCLOS on marine scientific research in the exclusive economic zone and on the continental shelf covers both, research ‘to increase scientific knowledge of the marine environment for the benefit of

Common pools for marine genetic resources 407 all mankind’ (Article 246.3), as well as research projects ‘of direct significance for the exploration and exploitation of natural resources, whether living or non-living’, thus for commercial gain (Article 246.5). In case of such marine scientific research, the UNCLOS provides for non-monetary benefit-sharing through its obligations: to publish and disseminate information on proposed major marine scientific research programmes and their objectives, as well as knowledge resulting from marine scientific research (Article 244.1); and to promote data and information flow and the transfer of knowledge (Article 244.2), as well as international cooperation in marine scientific research for peaceful purposes on the basis of mutual benefit (Article 242). With regard to marine scientific research in the Area, Article 256 UNCLOS refers to the provisions of Part XI UNCLOS where Article 143.1 foresees that scientific research in the Area shall be carried out for the benefit of mankind as a whole and in accordance with Part XIII, and Article 143.3 obligates states to promote international cooperation in marine scientific research in the Area, including by effectively disseminating the results of research and analysis. It is important to note that the scope of Part XIII of the UNCLOS is not limited to any type of resource. Furthermore, the limitation of the scope of Part XI does not apply to scientific research in the Area which becomes clear when comparing the exact wording of Article 143.1 and 143.3 UNCLOS referring to ‘scientific research in the Area’ with the wording of Article 143.2 UNCLOS referring to ‘scientific research concerning the Area and its resources’. Consequently, the (non-monetary) benefit-sharing regime established for marine scientific research is not limited to nonliving resources and therefore also applies to marine genetic resources in all ABNJ. However, while the provisions on marine scientific research provide a legal basis for a non-monetary ABS regime related to marine genetic resources in ABNJ, further regulations would be necessary in order to provide legal clarity and to promote the effective and efficient implementation of the regime. It can be concluded that multiple competing interpretations are possible with regard to the legal status of marine genetic resources in ABNJ, as well as the legal regime applicable to ABS. As none of the existing legal frameworks sufficiently addresses the issue as envisaged by the UNGA Resolution 66/231, the following section will discuss the pros and cons of options to close this gap.

Common pools of marine genetic resources as an option for a possible future regime When discussing possible options for a future ABS regime for marine genetic resources in ABNJ, it is important to understand the polarized

408 Thomas Greiber discussions which have taken place in the BBNJ WG throughout the years. On the one hand, a small number of developed countries have reiterated their discontent with changing the status quo and have denied the need for any ABS regulation (UNGA 2010b: 15). Instead, the concern has been repeated that future benefit-sharing obligations could have a negative impact on research and development (R&D) from which humanity as a whole would actually benefit. On the other hand, mostly developing countries have argued in favour of enlarging the scope of the UNCLOS regime of Part XI to cover also marine genetic resources which would then become part and parcel of the common heritage of mankind (UNGA 2010b: 15). These polarized discussions can only be overcome through the design of a flexible, efficient and effective regime which aims to ‘contribute to the realization of a just and equitable international economic order which takes into account the interests and needs of mankind as a whole and, in particular the special interests and needs of developing countries’ (Paragraph 5 UNCLOS Preamble), and at the same time offers potential benefits for those players who currently lead the R&D sectors related to marine genetic resources in ABNJ. For this, a number of difficult questions need to be answered, for example with regard to: •

•

•

•

The scope of the regime: whether to differentiate between pure and applied (commercial) research, as well as whether to distinguish between rules for marine genetic resources found in the water column and those in the Area; Fair procedures for access: whether due to the potential negative impacts of bioprospecting activities minimum guidance and standards are required in order to balance the interest in collecting marine genetic resources with the need for their sustainable use and the conservation of the ecosystems which they are part of; Rules for equitable benefit-sharing: how to share benefits from the utilization of marine genetic resources with the entire international community without hindering R&D through over-regulation or the creation of disincentives; or Practical approaches to monitoring and compliance: how to ensure the traceability of access to and utilization of marine genetic resources in ABNJ, as well as possible synergies with tools established under existing ABS regimes, such as the Nagoya Protocol.

Considering the above, an ABS regime for marine genetic resources in ABNJ could be built on the following ideas. First of all, a legal basis for the regime could be found in the UNCLOS provisions on marine scientific research. The already existing, non-monetary benefit-sharing regulations in Part XIII as well as Part XI of the UNCLOS would then provide the starting point for the development of further implementing rules. In addition, to overcome the polarized discussions on ‘common

Common pools for marine genetic resources 409 heritage of mankind’ and ‘freedom of the high seas’, marine genetic resources in ABNJ could be considered as a so-called ‘common concern of mankind’. This would confirm that activities related to marine genetic resources in ABNJ cannot be considered as solely subject to flag state jurisdiction due to their global importance for all; it would express the need for action at the global level in the long-term interests of humanity; and it would reaffirm the shared duty to cooperate for their conservation and sustainable use. At the same time, referring to the provisions on marine scientific research as well as the principle of common concern of mankind would help to avoid the difficulties associated with attributing marine genetic resources to either the UNCLOS regime of the Area (Part XI UNCLOS) or the regime of the high seas (Part VII UNCLOS), given that the resources are present in both the seabed and the water column above. The substantive scope of the ABS regime could be defined by clarifying that marine scientific research comprises both pure as well as applied (commercial) research. Such a broad understanding of marine scientific research would take into consideration that due to its financial and technical complexities, marine scientific research in ABNJ is often undertaken by a consortium of partners including private and public entities, with public as well as private financial resources, and following mixed goals (basic scientific research but also envisaging later commercial developments). Geographically, the regime could apply to all marine genetic resources in ABNJ, thus the soil and subsoil as well as the water column beyond the exclusive economic zone. Such a wide geographical scope would be necessary in order to ensure a fully comprehensive and practical ABS regime without serious loopholes. It would respond to the fact that both benthic and pelagic marine genetic resources are subject to marine scientific research, and that certain organisms also ‘migrate’ between the seafloor and the water column. Access to in situ marine genetic resources in ABNJ could be regulated through an obligation (of states) to develop domestic legislation concerning R&D under their jurisdiction in line with internationally agreed upon standards or guidelines which could require: prior environmental impact assessments (EIA); the issuing of a permit by a national authority before access is allowed, based on the EIA outcomes; and the submission of a granted permit to an international clearing-house mechanism. The latter would be important in order to facilitate monitoring of bioprospecting activities, to ensure transparency and traceability of marine genetic resources accessed in ABNJ, to provide a trigger for benefit-sharing obligations, and also to avoid unnecessary resampling of marine genetic resources in ABNJ, a practice which could increase destructive impacts on biodiversity. Still, monitoring compliance and enforcement of national access legislation would remain the flag state’s responsibility.

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Equitable benefit sharing could be achieved through the development of common pools of samples (ex situ resources) as well as related data. Such common pools would allow a broad range of benefit-sharing options, avoid a ‘one size fits all’ benefit-sharing approach, and create benefits for ‘all sides’, including those who invest into bioprospecting activities and therefore need to be rewarded for their risk-taking. It is important to note in this context that the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA) has already been suggested in the BBNJ WG discussions as a potential basis for developing benefit-sharing arrangements (UNGA 2011b: 11). It is clear that the benefit-sharing approach taken by the ITPGRFA, including its multilateral system (MLS), cannot be simply copied to regulate the sharing of benefits associated with marine genetic resources from ABNJ, as considerable differences exist in both cases. While crops have been exchanged and improved for centuries in order to adapt wild species to human or animal needs for food/feed, leading to an interdependence of all countries today, there is no such history of exchange of marine genetic resources from ABNJ, and therefore no comparable interdependence. Furthermore, the MLS under the ITPGRFA deals with a limited number of genetic resources listed in Annex I. While these resources were selected based on their importance for food security and their interdependence, developing a comparable list for marine genetic resources from ABNJ is impossible, as no adequate selection criteria exist. This is even more so, as the same marine genetic resources are sometimes found in ABNJ but also in the exclusive economic zone of a coastal state. Despite these differences, it is still possible to draw interesting lessons from the ITPGRFA’s benefit-sharing approach, which could be adapted to the peculiarities of marine genetic resources from ABNJ. For example, different non-monetary benefits could be recognized and promoted, such as capacity building, joint research and joint ventures; facilitated access to common pools consisting of repositories and/or databanks; but also nonuse benefits (meaning conservation itself, as well as improved scientific understanding). In addition, benefit-sharing obligations (including monetary benefits) could vary according to types of utilization of the marine genetic resources, taking into consideration the different sectors (commercial vs. research), as well as the different steps within the chain of bioprospecting, from collecting and sampling of marine genetic resources to inventing, patenting and developing products on their basis. Common pools of marine genetic resources and related data could be created through an obligation to make samples from publicly funded bioprospecting initiatives, as well as related research results available to others. Resources as well as research results stemming from privately funded initiatives could be also included, but on a voluntary basis. Submitting, storing and facilitating access to such ex situ material and related information would provide an important form of (non-monetary)

Common pools for marine genetic resources 411 benefit sharing to marine scientific researchers (academic as well as commercial) all over the world, including researchers from developed countries who cannot participate in every bioprospecting initiative and would receive access to additional material/data through the common pools system. In addition, accessing samples/data from one of the common pools could trigger an obligation to share the results of research derived from the original samples/data. Such information could again be made accessible to anyone. In view of the polarized debate around the legal status of marine genetic resources in ABNJ, it is important to understand that such a common pools approach would not mean relinquishing all property rights. Indeed, the sharing of samples and data could be based on an open-source/commons licence that allows for non-exclusive commercial or non-commercial licences. Individuals, institutions and companies seeking to pursue patent rights that make use of knowledge and/or resources covered by an ABS commons licence could be required to seek a commercial licence from providers through additional agreements, which could then include the payment of royalties for the use of the initial samples/data. In practice, this would mean that ex situ materials and data stored in common pools could be used for further research or even development under certain conditions specified in standard licence agreements. If the results of such R&D were shared (i.e. given back to the common pools system), no benefit-sharing obligations would arise. If they were protected, however, a benefit-sharing obligation would kick in. Last but not least, in order to monitor the utilization of marine genetic resources from ABNJ and to ensure compliance with the ABS regime, concepts already included in the Nagoya Protocol, such as the international certificate of compliance or effective checkpoints, could also be used in the context of marine genetic resources from ABNJ. A certificate of compliance, for example, could be the access permit issued by a national authority and published in the clearing-house mechanism. To serve its purpose, it could include certain key information, such as the level of public or private funding involved in a bioprospecting initiative. Furthermore, checkpoints established at the national level in order to monitor the utilization of genetic resources covered by the Nagoya Protocol could also serve as monitoring tools for marine genetic resources from ABNJ.

Conclusion It can be concluded that marine genetic resources in ABNJ are of great socio-economic importance and at the same time play a critical role in the context of future international efforts to promote the conservation and sustainable use of biodiversity in ABNJ. As ABS in relation to such

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resources is not sufficiently regulated by any international legal instrument so far, an implementing agreement under the UNCLOS could close this existing gap by further elaborating the benefit-sharing regime related to marine scientific research. The concept of common pools for marine genetic resources from ABNJ, as well as related research information promises to provide interesting options in this regard. Such common pools have the potential to create benefits for the entire international community without hindering future R&D, and thereby to ‘contribute to the realization of a just and equitable international economic order which takes into account the interests and needs of mankind as a whole and, in particular the special interests and needs of developing countries’ (Paragraph 5 UNCLOS Preamble).

References Arico, S and Salpin, C (2005) Bioprospecting of genetic resources in the deep seabed: scientific, legal and policy aspects, UNU-IAS Report. Arnaud-Haond, S, Arrieta, JM and Duarte, CM (2011) ‘Marine biodiversity and gene patents’, Science, 331 (6024), 1521–1522. Arrieta, JM, Arnaud-Haond, S and Duarte, CM (2010) ‘What lies underneath: conserving the oceans’ genetic resources’, Proceedings of the National Academy of Sciences of the United States of America (PNAS), 107 (43): 18318–18324. Census of Marine Life (2011) ‘Scientific results to support the sustainable use and conservation of marine life. A summary of the results of the census of marine life for decision makers’, Washington DC. Cicin-Sain, B, Maqungo, S, Arico S and Balgos, M (2008) ‘Submission of the Global Forum on Oceans, Coasts, and Islands to the UN Ad Hoc Open-Ended Informal Working Group to study issues relating to the conservation and sustainable use of marine biological diversity beyond areas of national jurisdiction’, http://www. globaloceans.org/sites/udel.edu.globaloceans/files/GlobalForumSubmission2ndAdHocWGMeeting-April2008-red_0.pdf, viewed 26 January 2013. Convention on Biological Diversity (2005) ‘Status and trends of, and threats to, deep seabed genetic resources beyond national jurisdiction, and identification of technical options for their conservation and sustainable use’, UNEP/CBD/ SBSTTA/11/11, Montreal, http://www.cbd.int/doc/meetings/sbstta/sbstta-11/ official/sbstta-1-1-en.pdf, viewed 26 January 2013. Korn, H, Friedrich, S and Feit, U (2003) Deep sea genetic resources in the context of the Convention on Biological Diversity and the United Nations Convention on the Law of the Sea, BfN-Skripten 79, Federal Agency for Nature Conservation, Bonn. Leary, D, Vierros, M, Hamon, G, Arico, S and Monagle, C (2009) ‘Marine genetic resources: a review of scientific and commercial interest’, Marine Policy, 33 (2), 183–194. Ruth, L (2006) ‘Gambling in the deep sea’, EMBO Reports, vol. 7, no. 1, European Molecular Biology Organization, http://www.oglf.org/Ruth.EMBO.06.pdf, viewed 26 January 2013. UNEP (2006) ‘Ecosystems and biodiversity in deep waters and high seas’, UNEP Regional Seas Reports and Studies No. 178, UNEP/ IUCN, Switzerland.

Common pools for marine genetic resources 413 United Nations Conference on Sustainable Development (2012) Agenda Item 10: Outcome of the Conference ‘The future we want’, UN Doc. A/Conf. 216/L.1, Rio de Janeiro. UNGA (2007) 62nd Session of the UN General Assembly, Report from the Secretary General on oceans and the law of the sea, UN Doc. A/62/66, New York. UNGA (2010a) 65th Session of the UN General Assembly, Resolution on oceans and the law of the sea adopted by the UN General Assembly, UN Doc. A/Res/65/37, New York. UNGA (2010b) 65th Session of the UN General Assembly, Letter dated 16 March 2010 from the co-chairpersons of the Ad Hoc Open-Ended Working Group to the President of the General Assembly, UN Doc. A/65/68, New York. UNGA (2011a) 66th Session of the UN General Assembly, Resolution on oceans and the law of the sea adopted by the UN General Assembly, UN Doc. A/Res/66/231, New York. UNGA (2011b) 66th Session of the UN General Assembly, Letter dated 30 June 2011 from the co-chairs of the Ad Hoc Open-Ended Informal Working Group to the President of the General Assembly, UN Doc. A/66/119, New York.

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Index

Notes have not been indexed. Figures are shown by italic page numbers and tables by bold page numbers. access and benefit sharing (ABS) regime, 1, 5, 204–17, 294–8, 343–4; administrative burden, 205–7; aquaculture, 174–5; in ASEAN, 145–6; bilateral approach, 107, 308–9; centralized approach, 218–19; in China, 153–8, 162–4; collections, 249, 256–8; Competent National Authority, 218; databases, 280–1; decoupling benefit from use, 259–60; East Africa, 374–84; effects from, 204–17; incentives from, 209–13; IPEN (International Plant Exchange Network), 251–3; legal clarity, 208, 210, 216; in Malaysia, 128–30; marine genetic resources, 407–11; Multi-Stakeholder Expert Dialogue, 194; outside of ITPGRFA, 109; problems with, 73–4, 217–22, 313; stakeholders, 215; traceability, 206–7; transaction costs, 206–7, 209; trust in, 207–9; see also ITPGRFA (International Treaty on Plant Genetic Resources for Food and Agriculture) accession numbering, 278 access to collections, 249, 256–8 access to knowledge, 35, 179–84, 344; China, 152, 153–4, 157–60, 162–4; Kukula of South Africa, 34–5; SMTA (standard material transfer agreements), 181–2, 255–6; see also

access and benefit sharing (ABS) regime access to land, 30–1, 62, 73 access to material, 346–7; see also multilateral system (MLS) ACTA (Anti-Counterfeiting Agreement), 176 administrative issues, 205–7, 217 agriculture, 18–19, 116–18, 193–4, 214–15; see also agrobiodiversity; ITPGRFA (International Treaty on Plant Genetic Resources for Food and Agriculture) agrobiodiversity, 9–10, 79–81, 113–15; in Malaysia, 139; Potato Park, Peru, 87–90; zones, 93–4, 95, 103–5, 118–20 allocation of genetic resources: see equity alternative medicines: see traditional medicinal knowledge Andean farmers, 9–10, 79–84 animal genetic resources, 112–13, 195–6; see also aquaculture Annex 1 list of ITPGRFA, 136–7, 173, 353, 379–82; crops, 344; East Africa, 380–1; notification requirement, 345–6 appetite suppressant: see Hoodia plant APROTAC (Asociación de Productores de Tubérculos Andinos de Candelaria), 86–7

416 Index aquaculture, 13, 168–87, 196–7, 270; Census of Marine Life, 224; Norway, 169–71; see also salmon, transgenic AquAdvantage, 270 Areas Beyond National Jurisdiction (ABNJ), 400–7 Articulação Pacari: see Pacari, Brazil ASEAN (Association of South-East Asian Nations), 12, 127–8, 143, 145–6 Asian Consortium of Microbiological Resources (ACM), 202 Asian Vegetable R&D Center (AVRDC), 141 Australia, 238 avian flu crisis, 315–18, 328, 329; see also Pandemic Influenza Preparedness (PIP) BABS Regulations, South Africa, 35 backtracing, 272–6; see also traceability banana research, 144–5 BAPNET (Banana Asia Pacific Network), 144–5 Barbatimão extract, 71–2 barter markets in the Andes, 81–3 Baxter Healthcare, 329 benefit-sharing, 114, 184–6, 240–1, 349–51, 350, 361–4; agreements, 37, 43, 48–9, 73; collections, 173–4, 258–9; decoupling benefit from use, 221–2, 250; enforcement, 330; equity, 276–7, 331–4; Kukula of South Africa, 35; non-monetary, 407; PIP (Pandemic Influenza Preparedness Framework), 319, 321, 323–4, 336; South Africa, 237; see also access and benefit sharing (ABS) regime; multilateral system (MLS) benefit-sharing funds: of MLS, 361–4; national, 109, 110, 111; San-Hoodia pool, 43, 48, 50 bilateral approach, 217–19, 308–9, 313, 383; East Africa, 374–8 BIOBASE, 290–1, 292 Biocultural Community Protocol (BCP), Kukula of South Africa, 32, 34 biodiversity: conservation of, 49, 50; East Africa, 373–4; fund, 146;

marine genetic resources, 399–401; Pacari, 61–2, 65; tax, 17; see also agrobiodiversity; GBIF (Global Biodiversity Information Facility) Biogen case, in patent law, 183 biological control of pests, 202–3 biopiracy: Chinese traditional medicine, 163; Kukula of South Africa, 37 bioprospecting, 35, 378; marine genetic resources, 399–401, 406 biosafety, flu vaccine, 330 biosphere reserves, 7–8, 29–38 Blyde River Canyon Nature Reserve, South Africa, 30 Bolivia, 9–10, 84–5 botanic gardens, 251–3 Botswana, 40–1 Brazil, 10–11, 59, 60, 103–21; Buriti, 62–6; Cedro, 66–8; Cerrado, 55–8; Genetic Heritage Management Council (CGEN), 238; Pacari, 9, 56–68 Brazilian Agricultural Research Corporation, Embrapa, 103–5 Brazilian National Health Surveillance Agency (ANVISA), 59, 60 breeders’ rights, 16, 293–4 breeding programmes: aquaculture, 170–1, 196–7; selective breeding, 195–6; see also plant breeding Budapest Treaty, 255 Buriti, Brazil, 62–6 Burundi: see EAC (East African Community) Bushbuckridge, South Africa, 7–8, 29–38 Bushmen: see San people CACMS (China Academy of Chinese Medical Science), 158 cassava, 109–12 Catholic Health Care Pastoral, 58 CBD (Convention on Biological Diversity), 235–6, 255, 261, 374–5; access to knowledge, 35; Article 1, 305–6; Article 15, 306; marine genetic resources, 403–5; role of

Index 417 databases, 279; sovereign rights, 106–7; see also access and benefit sharing (ABS) regime; Nagoya Protocol (NP) Cedro, Brazil, 66–8 centralized approach, 218–19 Cerrado, Brazil, 55–8; see also Pacari CGIAR (Consultative Group on International Agricultural Research), 235–6, 346, 359, 360–1 China: access and benefit sharing (ABS) regime, 153–8, 162–4; access to knowledge, 152, 153–4, 157–60, 162–4; CACMS (China Academy of Chinese Medical Science), 158; compensation in, 162; government, 152–3; Institute of Information on Traditional Chinese Medicine (IITCM), 157–8; intellectual property rights (IPR), 154–5; legislation in, 152–5, 162–4; local approaches in, 164; Nagoya Protocol (NP), 164; National Scientific Data Sharing Platform, 158–60; see also Chinese traditional medicine Chinese traditional medicine, 12–13, 150–64, 288; biopiracy, 163; databases, 151, 155, 157–8, 159, 288; Encyclopedia of Classics, 161; legal status, 152–5; ownership, 151, 156–7, 160, 161; patents, 156–7 citrus collection, Malaysia, 136 civil law rights, 162 climate change, 196 coconuts, 12, 62 COGENT (International Coconut Genetic Resources Network), 12 collections: decoupling benefit from use, 259–60; ex situ, 215, 246–61; IARCs (International Agricultural Research Centres), 346; as intermediaries, 261; microbial genetic resources, 226–8; national, 103–5, 136, 137–8; networks of, 140–5; not included in the MLS, 139–40; public, 132, 249; in situ, 113–15, 139; subject to ITPGRFA, 134–6; as ‘users,’ 256, 258–9 collective knowledge, 151

collective rights, 162 commercialization, 175, 349–52; of marine genetic resources, 400–1; of potatoes, 86–7; of traditional medicine, 65 commodification of health, 66, 71 Common Fund for Biodiversity Conservation, 146 common goods, 359 common heritage approach, 116–18, 308 common pool concept, 4–5, 172, 228–31, 325–6; legal basis in East Africa, 389–95, 393–4; marine genetic resources, 407–12; within MLS, 346, 351–3; see also pooling community approach, 32, 87–90 community pharmacies: Cedro, Brazil, 66–8; Pacari, 58 community rights, 89–90 compensation: in China, 162; for the San people, 43 Competent National Authority, access and benefit sharing (ABS) regime, 218 complementary medicine: see traditional medicinal knowledge confidentiality agreement, South Africa, 36 conservation: of biodiversity, 49, 50; crop diversity, 79–81; role of ex situ collections, 246 contracting parties, 134–6, 356–7 contract law, 185 Convention on Biological Diversity (CBD): see CBD (Convention on Biological Diversity) cooperative approaches, 17–18, 310–12, 383–4 copyright, 16, 291–2 cosmetics, 35–7 Costa Rica, 238 Council for Scientific and Industrial Research (CSIR), South Africa, 8, 42–3 Creative Commons, 291–2 crops, 198–200, 344; East Africa, 373–4; Malaysia, 130, 135; see also Annex 1 list of ITPGRFA

418 Index CSIR (Council for Scientific and Industrial Research), South Africa, 8, 42–3 culinary traditions, 115–18 cultural heritage, 115–18, 152–3 customary laws, 7–8, 95; Kukula of South Africa, 29–38; Potato Park, Peru, 89–90 Damara people, 41, 48 databases, 147, 268–70, 276–7, 281–2; Chinese traditional medicine, 151, 155, 157–60; commercial, 290–1; marine genetic resources, 15–16, 270–82; promoting R&D, 278–9; protein sequence data, 289–90; public, 288; Universal Protein Knowledge Base, 289–90; weaknesses, 279–81 derivatives, 233, 296 developing countries, 306–7, 363–4; avian flu crisis, 318; challenges of notification, 355 diabetes, 41, 65 dietary diversity, 115–18 dispute resolution, 331 distribution of funds, Kukula of South Africa, 37 DNA sequences, 289, 293 documented knowledge, 346; Chinese traditional medicine, 151, 155–7 drugs, 59–60, 401 EAC (East African Community), 20, 387–95 EAPGREN (Eastern Africa Plant Genetic Resources Network), 363–4, 384–7 Earth Summit, 110 East Africa, 19–20, 373–4, 379–82; ITPGRFA (International Treaty on Plant Genetic Resources for Food and Agriculture), 380–1, 382; legal basis, 389–95, 393–4; see also EAC (East African Community) East African Community Transboundary Ecosystems Management Bill, 392 ECCO (European Culture Collections’ Organisation), 231–3, 253–4

efficacy, of traditional medicine, 69 Embrapa, Brazilian Agricultural Research Corporation, 103–5 Encyclopedia of Classics, Chinese traditional medicine, 161 endemism, 374 equity, 3–4, 286, 305–6, 350, 362–4; allocation of genetic resources, 306–8, 330; Andean farmers, 95; in aquaculture, 16; benefit-sharing, 331–4; horizontal equity, 48–9, 276–7, 378; in marine genetic resources, 410; San-Hoodia pool, 8, 45; vertical equity, 49, 351–2, 378 Eterna, Dona, 65 Ethiopia, 19–20, 375–8 European Biological Resource Centres Network (EBRCN), 202 European Culture Collections’ Organisation (ECCO), 231–3, 253–4 exchange of genetic resources, 13–14, 127–8, 228; microbial genetic resources, 14–15; PIP (Pandemic Influenza Preparedness Framework), 327–34; plants, 200; see also IPEN (International Plant Exchange Network) exclusions from ITPGRFA, 146 exclusive rights, 178, 295 ex situ collections, 246–61, 346; public access, 255 fairness: see equity family ownership, 151 FAO (Food and Agriculture Organization), 94, 193–4; see also ITPGRFA (International Treaty on Plant Genetic Resources for Food and Agriculture) farmers’ rights, 92–3, 94, 113–15, 121; Andean farmers, 95; potatoes, 90–2 farmers’ role, 79–81, 84–6, 120 financing: PIP (Pandemic Influenza Preparedness Framework), 321, 324, 333; see also benefit-sharing fund; funds fish breeding: see aquaculture fish stocks, 20 Fitoscar ointment, 71–2

Index 419 food, 18–19, 193–4, 214–15 food crops: see Annex 1 list of ITPGRFA food security, 79–81, 87, 95, 127–8 forage crops, 344 Forest Code, Brazil, 62 forest genetic resources (FGR), 197–8 France, 346, 356 free-rider problem, 229, 231, 286, 358–9; copyright, 293–4 funds, 37, 146, 281–2; see also benefitsharing fund GBIF (Global Biodiversity Information Facility), 271–2, 274, 275, 282, 288 GEF (Global Environment Facility), 277 GenBank, 270–1, 272, 273, 276; DNA sequences, 289 genebank collections, 180; RGBIS (Rice Genebank Information System), 139; see also GenBank genetically modified animals, 170 genetic diversity, 343–4 Genetic Heritage Management Council (CGEN), Brazil, 238 genomics, 289 German Collection of Microorganisms (DSZM), 15, 253–4 Germany, 15, 49, 247, 253–4 GIAHS (Globally Important Agricultural Heritage System), 94 GISRS (Global Influenza Surveillance and Response System), 227, 316–17, 319, 322, 327 GlaxoSmithKline, 328 Global Crop Diversity Trust, 87 Godding and Godding cosmetics, 35–7 governance, 89–90, 175, 228–31 governments: Brazil, 59–61; China, 152–3; involvement in aquaculture, 196–7; Malaysia, 132; ownership of collections, 345–6; patent law, 179 harmonization, 219–20 healers, Kukula of South Africa, 29–38 health challenges, 58–61 health practitioners, 70–1 herbal medicine: see Pacari; San-Hoodia pool

heritage approach, 94, 116–18, 152–3, 308 Hoodia Growers Association of Namibia (HOGRAN), 45 Hoodia plant, 8, 40–1; see also SanHoodia pool Huang Cen Tang, 156 human rights, 95 hypertension, 65 IARCs (International Agricultural Research Centres), 346 incentives: access and benefit sharing (ABS) regime, 209–13; in aquaculture, 186; to contribute to common pool, 174–5, 178–9, 184–6; copyright, 292, 294; for investment, 212–13 indigenous and local communities (ILO), 62–8; see also Kukula of South Africa; Pacari; San people Indonesia, 317–18, 329 influenza pandemic response, 227, 315–18, 328; see also GISRS (Global Influenza Surveillance and Response System); Pandemic Influenza Preparedness (PIP) Influenza Virus Traceability Mechanism (IVTM), 328 informal exchange networks, 228 information systems, 211, 345–6; in Malaysia, 138–9; see also databases innovation in aquaculture, 175–9, 186 INSDC (International Nucleotide Sequence Database Collaboration), 238, 289 in situ collections, 113–15, 139 Institute of Information on Traditional Chinese Medicine (IITCM), 157–8 intellectual property rights (IPR), 16–17, 112, 182, 293–5, 364–5; Cerrado, Brazil, 71; China, 154–5; fish breeding, 171; multilateral system (MLS) weakness, 355; potatoes, 90–2; San-Hoodia pool, 49; sui generis system, 171–2; TRIPS Agreement, 91, 171, 176 international agreements, 17–21; marine genetic resources, 402–3; see

420

Index

also ITPGRFA (International Treaty on Plant Genetic Resources for Food and Agriculture) International Coconut Genetic Resources Network (COGENT), 142–4 international law, 17, 35, 90; see also ITPGRFA (International Treaty on Plant Genetic Resources for Food and Agriculture) international networks, 140–5; see also multilateral system (MLS) International Potato Center, 10, 85, 87 International Union for Conservation of Nature (IUCN), 118 investment, incentives, 212–13 IPEN (International Plant Exchange Network), 15, 247, 251–3 IPHAN (Instituto do Patrimônio Histórico e Artístico Nacional), 117–18 IPK (Institut für Pflanzengenetik und Kulturpflanzenforschung), 248 IPR: see intellectual property rights (IPR) ITPGRFA (International Treaty on Plant Genetic Resources for Food and Agriculture), 134, 173–4, 179–80, 343–4; in Brazil, 107–8, 120; exclusions, 146; implementation at national level, 131–2, 220; in Malaysia, 128–32; marine genetic resources, 410; potatoes, 88–9, 92; role of farmers, 105, 113; website search example, 346–7, 348; see also Annex 1 list of ITPGRFA; SMTA (standard material transfer agreements) IUCN (International Union for Conservation of Nature), 118 justice perspective, 305–13 K2C Biosphere Reserve, 7–8, 29–38 Kalahari desert, 40–1 Kenya: see EAC (East African Community) knowledge commons, 16–17, 285–8, 296–8; documented knowledge, 151,

155–7, 346; oral knowledge, 152, 155–7 Kruger to Canyons (K2C) Biosphere Reserve, 7–8, 29–38 Kukula of South Africa, 7–8, 29–38 legal clarity: access and benefit sharing (ABS) regime, 208, 210, 216; in Nagoya Protocol (NP), 217 legal persons, 356–9 legal reserves, 61–2; see also reserves legal status: Chinese traditional medicine, 152–5; of genetic material in Brazil, 105–7; in Malaysia, 132–4, 357; of marine genetic resources, 411 legislation, 6, 73–4, 295, 344, 374–5; in Brazil, 59–60, 61, 105–7; in China, 152–5, 162–4; in East Africa, 389–95, 393–4; in Malaysia, 128–30; in Norway aquaculture, 169–72; patent law, 175–9, 182–4; in Peru, 90; private law agreements, 181, 197; in South Africa, 35; see also international law; ITPGRFA (International Treaty on Plant Genetic Resources for Food and Agriculture) livestock: see animal genetic resources living pharmacies, 9, 56–7, 62–6 local approaches, 7–10, 94; in Brazil, 70–1; in China, 164; see also SanHoodia pool Madagascar, 374 maize breeders’ association, France, 346 Malaysia, 11–12, 128–30; government, 132–4; Standard Material Transfer Agreements (SMTA), 129–30; state collections, 137–8; see also MARDI (Malaysian Agricultural Research and Development Institute) manioc, 109–12 MARDI (Malaysian Agricultural Research and Development Institute), 11–12, 138–9; legal status, 132–4, 357 marine genetic resources, 13, 399–412; databases, 15–16, 270–82; legal

Index 421 status, 411; multilateral agreements, 20–1; see also aquaculture MAT (mutually agreed terms), 254, 309; see also prior informed consent (PIC) material transfer agreements (MTAs), 200, 231–3, 234, 378; flu vaccine strains, 317; microbial genetic resources, 228; see also SMTA (standard material transfer agreements) MCCs (Microbial culture collections), 201 meta-databases, 290 microbial genetic resources, 14–15, 200–2, 226–42, 253–4 Millenium Ecosystem Assessment, UNEP, 224 MLS (Multilateral System): see multilateral system (MLS) molecules, 269–70 Moleque, Chico, 66 monitoring, 277–8, 352–3, 411; see also databases; traceability Morais, Lucely, 66 MTAs (material transfer agreements): see material transfer agreements (MTAs) multilateral system (MLS), 180, 250, 311–12, 343–4, 379–82; access to knowledge, 181–2; access to material, 346–7; benefit-sharing, 240–1, 349–51; collections, 256–8; as a common pool, 346, 351–3; criteria for inclusion, 173; database use, 345–6; East Africa, 379–82; extent, 277, 353; flow of material and benefits, 200, 347–8, 350; imbalanced rights, 355–60; intellectual property rights (IPR), 355; Malaysia, 137–8; Nagoya Protocol (NP), 256; notification requirement, 353–4; obligation to share, 349–51; see also ITPGRFA (International Treaty on Plant Genetic Resources for Food and Agriculture); SMTA (standard material transfer agreements) Multi-Stakeholder Expert Dialogue, 194

Nagoya Protocol (NP), 35, 224–6, 241, 375, 383–4; alternative, 175; Article 2, 296; Article 4, 193–4, 247, 256–61, 277; Article 10, 307, 312; Article 15, 246–7; China, 164; comparisons with PIP, 334–7; future developments, 239–41; marine genetic resources, 403–5; microbial genetic resources, 14–15, 235–42; Pacari, 73; prior informed consent (PIC), 91–2; research and development, 235–9, 246–7; see also multilateral system (MLS) Nama communities of Namibia, 45, 48 Namibia, 40–1, 45, 48 national approaches, 10–13; see also Brazil; China; Malaysia; Norway; South Africa National Genetic Resources Platform, Brazil, 10–11, 103–4 National German Collection of Microorganisms and Cell Cultures (DSMZ), 247 National Health System (SUS), Brazil, 59, 65, 68, 71 National Scientific Data Sharing Platform, China, 158–60 National System of Conservation Units (SNUC), Brazil, 61–2 NCBI (National Center for Biotechnology Information), 271 Negro River, Brazil, 116 NEMBA regulations, South Africa, 35 Netherlands, 86 networks of collections, 15, 140–5 New Zealand, 86 Niuhuang qinxin pills, 156 Norway, 13, 109, 169–72, 186–7 notification requirement (ITPGRFA), 345–6, 353–5 novelty, in patent law, 182–3 oceans: see marine genetic resources Open Source Model, 249 open source regulations, 184–6 oral knowledge, 152, 155–7 overexploitation: Cerrado, Brazil, 71; of Hoodia, 43

422

Index

ownership, 114, 164, 237–8, 345–6; Chinese traditional medicine, 151, 156–7, 160, 161; legislative suggestions in China, 162–4; microbial genetic resources, 232; private-public partnerships, 170 Pacari, Brazil, 9, 56–68 Pandemic Influenza Preparedness (PIP), 18, 318–25; as a common pool, 325–34, 336; see also GISRS (Global Influenza Surveillance and Response System); influenza pandemic response partnerships, 170, 311 patents, 112, 182–4; in aquaculture, 170, 176–9; Chinese traditional medicine, 156–7; common pool as alternative, 112, 176–7; DNA sequences, 293; failings, 185; Fitoscar ointment, 71–2; Hoodia plant, 42, 44; laws, 175–9, 182–4; marine genetic resources, 406; Pacari, 73; rights, 16, 293–4, 295 Peru, 10, 93–4, 116; Potato Park, Peru, 87–90, 356; seed fairs, 83–4 pest management, 202–3 Pfizer, 42–3 PGRFA (plant genetic resources for food and agriculture), 10, 193–4, 214–15, 343; East Africa, 373–4; France, 346; see also collections; ITPGRFA (International Treaty on Plant Genetic Resources for Food and Agriculture) pharmacia vivas, 9, 56–7, 62–6 Pharmacopoeia of the Cerrado, 58, 69 Pharmaq, 177–8 Phytopharm, 42–3 plant breeding, 95, 198–200, 343–4; see also potatoes political context, 73–4, 175, 402–3 pooling, 6–7, 219–20, 310–12; PIP (Pandemic Influenza Preparedness Framework), 336 potatoes, 9–10, 84–6; barter markets in the Andes, 81–3; marketing, 85–7; Potato Park, Peru, 10, 87–90, 356; prior informed consent (PIC), 90–2;

research, 84–7; rights of potato breeders, 91–2 Potato Park, Peru, 10, 87–90, 356 poultry, 195 ‘prior art,’ in patent law, 183 prior informed consent (PIC), 251–4, 256–7, 309; potatoes, 90–2 private collections, 173, 213, 345–6 private law agreements, aquaculture, 181, 197 private-public partnerships, aquaculture, 170 PROINPA (Promoción e Investigación de Productos Andinos), potato research, 84–5 ‘property and market’ approach, 3–5 property rights, Brazil, 105–7 protected areas: agrobiodiversity zones, 118–20; Peru, 93–4; see also reserves protein sequence data, 289–90 proteomics, 289–90 providers, 4, 309, 310–11; defined within Nagoya Protocol, 375; obligations under SMTA, 347–9 Provisional Act 2001 (Brazil), 105–7 public access, to collections, 255 public control, 173 public goods theory, 228–31 public knowledge, 151 public vs private, 345–6, 356–7; collections, 111, 249; marine bioprospecting, 401; partnerships, 170 PubMed, 271, 276 reciprocity, 111, 309, 364; barter markets in the Andes, 81–3; Kukula of South Africa, 31, 34; Potato Park, Peru, 89–90; in research, 242 regional cooperation, 383–4, 391; databases, 276–7, 281; see also San-Hoodia pool research and development, 23, 211, 224–6, 296, 352–3; agrobiodiversity zones, 96; biological control (BC) of pests, 202–3; disincentive of MLS, 362; governance of, 228–31; Kukula of South Africa, 35–8; Malaysia, 129; marine genetic resources, 407,

Index 423 410–11; within MLS, 235–9, 246–7; non-commercial, 235–9; potato seed in Andes, 84–6 reserves: Brazil, 61–2; K2C Biosphere Reserve, 7–8, 29–38 Rice Genebank Information System (RGBIS), Malaysia, 139 Rimba herbarium, Malaysia, 136 Rio Declaration, 110 royalties, 294 Rwanda: see EAC (East African Community) Sabah, Malaysia, 137–8 safety, of traditional medicine, 69 SAGE (Strategic Advisory Group of Experts on Immunization), 319–20 SAHGA (Southern African Hoodia Growers Association), 8 salmon, transgenic, 15–16, 270, 272–6; patent law, 177–8 San-Hoodia pool, 41–7, 46, 47 San people, 8, 40–1, 48–9 Sarawak, Malaysia, 137–8 SARS (sudden acute respiratory syndrome), 154 Scutellaria Decoction, 156 seed: collections, 79–81, 87; fairs, 9–10, 83–4, 94; forest genetic resources, 197–8; potatoes, 90–2; sales, 109–10, 111 seed oil, vernonia oil, 19–20, 375 selective breeding, 195–6; see also breeding programmes SMTA (standard material transfer agreements), 19, 180, 200, 347–9, 360–1; access to knowledge, 181–2, 255–6; IPEN (International Plant Exchange Network), 251–3; Malaysia, 129–30; PIP (Pandemic Influenza Preparedness Framework), 320, 322, 328–9, 335; restrictions, 250; see also material transfer agreements (MTAs) social aspects, 69–71 South Africa, 7–8, 42–3, 237; Kukula, 29–38; legislation, 35

sovereign rights, 306–7, 344, 374–5; aquaculture, 174–5; Brazil, 105–7; conflict with Nagoya Protocol, 240 ‘specialized instruments,’ Nagoya Protocol (NP), 247, 256–60 Standard Material Transfer Agreements (SMTA): see SMTA (standard material transfer agreements) statutory bodies, 135–6 stewardship approach, 114 sui generis system, 171–2 sustainability, 61–2, 74, 326 Svalbard Global Seed Vault (SGSV), 87 Switzerland, 49 Tanzania: see EAC (East African Community) tax: biodiversity, 17; biotechnology, 73 taxonomic classification, 73 TCMK (traditional Chinese medical knowledge): see Chinese traditional medicine Topnaar, San-Hoodia pool, 41, 48 traceability, 206–7, 221–2, 280; IPEN (International Plant Exchange Network), 251–3; role of databases, 268–70; salmon, 15–16, 272–6 Trade-Related Aspects of IPRs (TRIPS), 91, 171, 176 trade secret protection, 293–4 traditional chinese medicine: see Chinese traditional medicine Traditional Chinese Medicine Database System, 157–8, 159, 288 traditional knowledge (TK), 8, 29–38 traditional medicinal knowledge, 7–10, 33–5, 69–72, 150–64; see also Chinese traditional medicine; Pacari; San-Hoodia pool transaction costs, 206–7, 209, 219, 222 transboundary cooperation, 307–8, 310, 312; East African Community (EAC), 387–95; Nagoya Protocol (NP), 241, 383–4 transboundary species, 375–8 TRANSFAC, 290–1

424

Index

transfer agreements: see material transfer agreements (MTAs); SMTA (standard material transfer agreements) transfer of material, 347–9, 350; see also material transfer agreements (MTAs); SMTA (standard material transfer agreements) trees, 62, 197–8 TRIPS Agreement, 91, 171, 176 trust, in access and benefit sharing (ABS) regime, 207–9 trust fund, San-Hoodia pool, 43, 48–9 Uganda: see EAC (East African Community) ulcers, 71–2 UNCED (1992), 110, 224 UNCLOS (UN Convention on the Law of the Seas), 20 UN Convention on the Law of the Sea (UNCLOS), 306, 402–3, 405–9 UN Declaration on the Rights of Indigenous Peoples, Potato Park, Peru, 90 UNEP, Millenium Ecosystem Assessment, 224 UNESCO: cultural heritage sites, 115–18; World Network of Biosphere Reserves, 29 UNGA (United Nations General Assembly), 401–3 Universal Protein Knowledge Base, databases, 289–90 universities, 72, 135–6, 251–3 University of Malaya, legal status in Malaysia, 135 University of Ribeirão Preto (UNAERP), 72

UPM (Universiti Pertanian Malaysia), 135 use of material, 347–8; by collections, 256, 258–9 use-restriction agreement, Kukula of South Africa, 36 user pays principle, 110–11 vaccine for salmon, 177–8 vaccines against flu: see Pandemic Influenza Preparedness (PIP) Vernique BioTech Ltd, 378 vernonia galamensis, 19–20, 375–8 viral licence clause, 233 Vogel, Joseph, 310 WFCC (World Federation of Culture Collections), 15, 226–7, 231, 253–4 WIMSA, South Africa, 42–3 WIPO (World Intellectual Property Organization), 176 women, 62–6, 81–4 World Federation of Culture Collections (WFCC), 226–7, 231, 253–4 World Health Assembly (WHA), 18 World Health Organization (WHO): Director General, 319, 328; influenza pandemic response, 315–18; Shipping Fund Project, 327–8; traditional medicine, 59, 60 World Heritage Convention, UNESCO, 116–17 World Intellectual Property Organization (WIPO), 176 World Network of Biosphere Reserves, UNESCO, 29 WTO (World Trade Organization), 91