'Straightforward, honest, and uncompromising in describing the socio-political issues of food and the credible political options. There is not a policymaker on this planet who should not read this book. The authors know what they're talking about and their editors know who they're talking to. This is the best single summary of the political choices facing food and agriculture policymakers that has been written in this decade.'

Pat Mooney, Executive Director of the ETC Group

'This is a timely and valuable book about the most important "industry" of all, dominated by giant multinationals and governments of rich countries, who make the global rules. This concise overview is both authoritative and accessible for non-specialists – highly recommended to all who are concerned about food, health, and survival.'

Felix R. FitzRoy, Professor of Economics, University of St Andrews and Research Fellow, IZA, Bonn

'This book is an excellent resource for those mapping the increasing control of our food chain by international players. The agreements that impact on the ability of nations to be food-sovereign and food-secure are described in lucid detail. This is useful information for scholars and policymakers.'

Suman Sahai, Director, Gene Campaign, India

'In this volume, globally recognized legal and policy experts provide a comprehensive and outstanding analysis of the inter-relationships between intellectual property rights and systems for maintaining food quality, biosafety and plant biodiversity. These are demanding technical issues but have fundamental importance for the future of global agriculture. The book should be read by all concerned with how institutional and policy reforms in these critical areas will affect the livelihoods of poor farmers and the nutrition of societies worldwide.'

Keith E. Maskus, Professor of Economics and Associate Dean for Social Sciences, College of Arts and Sciences, University of Colorado at Boulder

'In a field dominated by slogans, mistrust, rhetorical claims and counterclaims, this is a welcome factual account – you do not have to agree with all it contains but it helps the reader towards a better understanding of the issues. That understanding could help create a critical mass of people who want the fair, practical and deliverable changes that will be essential as we move to meet the challenges of more people, climate change, equity and ecosystem conservation. Ownership may not be the issue – but control and choice are.'

Andrew Bennett, Executive Director, Syngenta Foundation for Sustainable Agriculture

'This book is an excellent collection of guideposts for perplexed students and scholars and a handbook for the seasoned diplomat seeking to make the world a better place for future generations.'

Professor Calestous Juma, Kennedy School of Government, Harvard University

'Intellectual Property Rights (IPRs) appear mind-numbingly complex but are fundamentally important. This book outlines what the IPRs and food debates are, and why we should wake up and take notice. As the world enters a critical phase over whether, and how, to feed people healthily, equitably and sustainably, the need to understand IPRs is central. It unlocks the struggle over who controls our food futures.'

Tim Lang, Professor of Food Policy, City University, London

'Vital for everyone who eats, gardens, shops, or farms; indeed anyone who cares how communities, nations and the whole human species inhabit the earth. The authors map changes in control over food taking place through a web of international agreements about 'genetic resources', intellectual property rights, biological diversity, investment and trade. This is a powerful and accessible one-of-a-kind guide to the complex issues, agreements and law surrounding who controls the future of the world food supply and an indispensable tool in the fight for a democratic future.'

Harriet Friedmann, Professor of Sociology, Centre for International Studies, University of Toronto

'The influence of IPRs has increased and is increasing – but ought it to be diminished? Today IPRs increasingly deal with the necessities of life, in particular medicine and food. Read this book to learn how IPRs may affect world food supply and to understand the political battlefield.'

Tim Roberts, Chartered Patent Attorney, UK, and Rapporteur to the Intellectual Property Commission of ICC

'As it informs, it draws attention to the far-reaching implications of international norms that impact on a basic need. I recommend it to all who play a role in the formulation of relevant international norms in whatever capacity, and regardless of the interests they may represent.'

Leo Palma, Deputy Director, Advisory Centre on WTO Law; formerly a Philippines negotiator at WTO, 1996–2001

'A long overdue analysis and critique of the premises underlying the push for a new 'Green Revolution', this book brings together seemingly disparate elements to show how, in combination with new intellectual property rules, they will create new dependencies and increase the marginalization of farming and poor communities. This book presents a cogent rebuttal of the industrialized and privatized model of food production prevalent in international trade and intellectual property norm-setting. An awareness of these elements will greatly assist civil society to participate in international negotiations.'

Daniel Magraw, President and Chief Executive Officer of the Center for International Environmental Law

'The Future Control of Food makes an invaluable and much-needed contribution to understanding the international state of play regarding food access, food development and intellectual property laws. The book will be useful not only to intellectual property and trade negotiators, but also to bankers, farmers, food service providers, environmental activists and others seeking to understand how food production is currently regulated and will be regulated in the future.'

Joshua D. Sarnoff, Assistant Director, Glushko-Samuelson Intellectual Property Law Clinic, Washington College of Law, American University, Washington, DC

'This is a timely book, providing useful insights on how international policies can, directly, indirectly and inadvertently, impact on food security. All stakeholders engaged in policymaking that affects the human food chain have a lot to gain by reading it.'

Emile Frison, Director General, Bioversity International

'This well-researched book condenses the essence of decades of negotiations concerning IPRs into a readable but disturbing narrative which juxtaposes detailed descriptions of the systems that privatize nature with examples of people's defence of agricultural biodiversity. For social movements and activists who want to defend food sovereignty, it is essential reading.'

Patrick Mulvany, Senior Policy Adviser, Practical Action/Intermediate Technology Development Group and Chair, UK Food Group

'This book unpeels the onion: it shows layer on layer of interests and pressures that will define how we feed, or do not feed, a world of nine thousand million people in 2050. We are in a time of new enclosures and privatization of what were public goods, such as biodiversity and genetic resources, through access and benefit sharing legislation, and of the food chain from gene to plate, through IPRs. If you want to understand the fault lines in our food systems, READ THIS BOOK.'

Clive Stannard, former Officer in Charge, Secretariat of the Commission on Genetic Resources for Food and Agriculture at the FAO

The Future Control of Food

A Guide to International Negotiations
and Rules on Intellectual Property,
Biodiversity and Food Security

Edited by Geoff Tansey and Tasmin Rajotte

First published by Earthscan in the UK and USA in 2008

Copyright © The Quaker International Affairs Programme, 2008

All rights reserved

ISBN:    978-1-84407-430-3 (hardback)
              978-1-84407-429-7 (paperback)

IDRC publishes an e-book edition of The Future Control of Food (ISBN 978-1-55250-397-3)

For further informtation, please contact:
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For a full list of publications please contact:

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Library of Congress Cataloging-in-Publication Data

The future control of food : a guide to international negotiations and rules on intellectual property, biodiversity, and food security / edited by Geoff Tansey and Tasmin Rajotte.

p. cm.

Includes bibliographical references and index.
ISBN-13: 978-1-84407-430-3 (hardback)
ISBN-10: 1-84407-430-7 (hardback)
ISBN-13: 978-1-84407-429-7 (pbk.)
ISBN-10: 1-84407-429-3 (pbk.)

1. Food law and legislation. 2. Plant varieties—Patents—Government policy. 3. Produce trade—Law and legislation. 4. Intellectual property (International law) 5. Food industry and trade—Standards. 6. Biodiversity conservation—Law and legislation. 7. Genetic resources conservation. I. Tansey, Geoff. II. Rajotte, Tasmin.

K3926.F88 2009
346.04'8'dc22

2007034792

The paper used for this book is FSC-certified and totally chlorine-free. FSC (the Forest Stewardship Council) is an international network to promote responsible management of the world's forests.

This book is dedicated to Sacha, Christine,
Rachel and all the children of this world.

May you inherit a world filled with hope, peace, food
and a diversity of life that sustains and nourishes
all of the Earth's peoples.

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Contents

List of Figures, Tables and Boxes

Figures

Tables

Boxes

Preface

Intellectual property (IP) rights are a source of hidden wealth worth trillions of dollars, and they impose hidden costs on the same scale. The rules of intellectual property range from confusing to nearly incomprehensible, and the professional practitioners who manage these rights sometimes seem to belong to a secret society.… The IP system also determines when and how an innovation becomes available for others to use by defining boundaries around what is accessible and what is not. Intellectual property rights help determine which innovations are widely available and which are closed off, separating innovation haves from have-nots. … Ever-stronger intellectual property protection is surely not a panacea to promote technology progress and wellbeing in all countries and industries … intellectual property creates winners and losers and on balance it helps in some situations, hurts in others … intellectual property shapes society – whether for better or for worse.

MICHAEL A. GOLLIN FROM Driving Innovation: Intellectual Property Strategies for a Dynamic World (Cambridge University Press, 2008)

In today's world, access to food is highly, and unacceptably, uneven. There is massive overproduction and over-consumption, and yet millions experience scarcity and hunger. This book looks at some of the forces and rules shaping the food system and who has control over it. In particular, it focuses on rules on intellectual property – for example patents, plant breeders' rights, trademarks and copyright – and their relations to other rules on biodiversity, an essential requirement for food security. It looks through the lens of intellectual property (IP) at the future control of food and farming, because rules on IP are central to struggles over the distribution of wealth and power in the 21st century.

When, from the 16th century onwards, the colonial powers reorganized the world to suit their economic interests, drew up state boundaries and secured resources for their use, they set the stage for trade patterns and future conflicts that still ring around the planet. Today, the colonies are mostly gone and there are around 200 nation states, yet through a series of quite unbalanced negotiations among these states, the most powerful countries are still able to shape the rules of the world in their interests. Nowadays, their concerns include intangibles like IP and the use of genetic resources. The new international rules on these, agreed since the early 1990s, will do much to shape the future control of food. Yet these often complex and remote negotiations are little known or influenced by the billions of people who will be affected by them. This book is a guide to both the negotiations and these new global rules. At stake are the livelihoods of 2.5 billion people still directly dependent on agriculture and the long-term food security of us all. The IP regime, a new factor in many countries, along with a changing trade regime and new agreements on biodiversity, will help shape the kind of agricultural development in the future. It may include most of these 2.5 billion people, or it may exclude them. Either way their livelihoods will be affected. Moreover, all of us will be affected by the way these rules are written, since they will also help shape the food system, the kind of products it produces and the structures through which it delivers them. It is important to know about the mix of rules because changes in one affect others, and concerns over IP overshadow many. Some of the questions that arise are:

• Will the rules facilitate and support the worthy but as yet unfulfilled goals of ending hunger and increasing food security espoused at food summits since the 1970s?

• Will they increase the capacity of those who need either more food or better food for a healthy life to produce or procure it?

• Will they promote fairer and more equitable practices among those engaged in ensuring that production reaches all who need it?

• Will they – the IP regime in particular – create incentives for more ecologically sound and culturally and socially appropriate farming, fishing and herding practices among producers of foodstuffs?

Guide to the Book

The decision to produce this book was, in part, a response to concerns negotiators in various multilateral negotiations raised about the need for such a guide as well as the observation that negotiators or groups working in one area were often unaware of, and sometime undermining, what was happening elsewhere, which we encountered in the Quaker programme of work in this area.1 In part, it is also a response to food security being the more neglected area by many governments and civil society groups compared with the new IP regime's impact on access to medicines and even access to knowledge. As a recent study noted: 'Unfortunately, for agriculture, genetic resources and traditional knowledge the benefit [for NGO involvement] does not seem to be visible and immediate, so … the pressure for policy outcomes is not as great as for public health and access to medicines' (Matthews, 2006).

This guide seeks to inform a wider audience than negotiators so that civil society, researchers and academics, as well as those leading peasant and farmers' groups, small businesses and government officials, can take a more informed and active part in the complex process of negotiations that lead to international agreements. In that way, a broader range of interests will be in a better position to judge if the rules need amending and be better informed to work locally, nationally and internationally to secure global rules that promote a just and sustainable food system.

Part I begins with a brief overview of the contemporary food system, the basics of IP and its role in the food system. The central core of the book is Part II, which provides the background and a guide to negotiations and the key elements of the agreements. The different chapters aim to:

• help readers see how IP has spread into food and agriculture through various agreements;

• provide a short guide to the background and history behind each of the agreements;

• highlight key issues in each of these agreements and emerging trends;

• note connections to other negotiations – multilateral, regional and bilateral – and national laws; and

• discuss the various interconnections and complex webs between the different rules and negotiations.

Part III includes discussion on some of the various civil society reactions to these changing global rules and their impact on research and development in Chapter 8. Chapter 9 reflects on these international negotiations and makes a number of observations that may help those seeking to learn lessons from what has gone on. The final chapter briefly draws together some conclusions about the negotiating processes, alternative futures and the nature of innovation needed to face them. Finally, at the end of the book, we provide a table of further resources and institutions to contact for more information.

Notes on Contributors

Heike Baumüller was Programme Manager, Environment and Natural Resources, at the International Centre for Trade and Sustainable Development (ICTSD) up to the end of 2006. Among other areas, she coordinated ICTSD's project activities on biotechnology, fisheries, trade and environment, and biodiversity-related intellectual property rights from 2000, was the Managing Editor of the ICTSD publication BRIDGES Trade BioRes, and has published on a range of issues related to trade and sustainable development. She holds a master's degree in Environmental Studies from Macquarie University, Sydney, and is now working freelance as a consultant in Cambodia.

Susan H. Bragdon is qualified in biology, resource ecology and law. She works on the conservation, use and management of biological diversity; creating compatibility between environment and agriculture; and promoting food security. She was the lawyer for the Secretariat for the Intergovernmental Negotiating Committee for the Convention on Biological Diversity (CBD), providing legal advice to the working group handling intellectual property rights, transfer of technology, including biotechnology, and access to genetic resources. She subsequently joined the treaty Secretariat as its Legal Advisor. From 1997 to 2004 she was a senior scientist dealing with law and policy at Bioversity International (formerly the International Plant Genetic Resources Institute (IPGRI)). She currently works as a consultant for intergovernmental organizations, governments and foundations.

Peter Drahos is a Professor in Law; he is Head of Programme of the Regulatory Institutions Network at the Australian National University (ANU), Director of the Centre for the Governance of Knowledge and Development at the ANU and a Director in the Foundation for Effective Markets and Governance. He also holds a Chair in Intellectual Property at Queen Mary College, University of London. He has degrees in law, politics and philosophy and is qualified as a barrister and solicitor. He has published widely in law and the social sciences on a variety of topics including contracts, legal philosophy, telecommunications, intellectual property, trade negotiations and international business regulation.

Graham Dutfield is Professor of International Governance at the Centre for International Governance, School of Law, University of Leeds. Previously he was Herchel Smith Senior Research Fellow at Queen Mary, University of London, and Academic Director of the UNCTAD-ICTSD capacity-building project on intellectual property rights and sustainable development. He has served as consultant or commissioned report author for several governments, international organizations, United Nations agencies and non-governmental organizations, including the governments of Germany, Brazil, Singapore and the UK, the European Commission, the World Health Organization, the World Intellectual Property Organization, and the Rockefeller Foundation.

Kathryn Garforth is a law and policy researcher and consultant working in the areas of biodiversity, biotechnology, intellectual property rights and health. She has attended numerous meetings of the CBD in a number of different capacities including as an NGO representative, on the Canadian delegation and as part of the CBD Secretariat. She has consulted widely for international organizations, national institutions and donors. She earned a joint law degree and master's in Environmental Studies from Osgoode Hall Law School, York University.

John E. Haapala Jr is an intellectual property attorney based in Eugene, Oregon. He is the former Director of the Farmer Cooperative Genome Project and the former Research Director for Oregon Tilth. He is also the owner/operator of Heron's Nest Farm and has been breeding and producing vegetable and flower seeds for the US organic seed market since 1988.

Michael Halewood is Head of the Policy Research and Support Unit of Bioversity International. He manages policy research projects with a broad range of partners, mostly from developing countries; he also coordinates representation of the International Agricultural Research Centres of the CGIAR at international genetic resources policy making negotiations. He was previously coordinator of the Crucible II Group, a global think-tank analysing genetic resources policy options.

Kent Nnadozie is a lawyer engaged in environmental and sustainable development law and policy issues. He is Director of the Southern Environmental and Agricultural Policy Research Institute (SEAPRI), an initiative of the International Centre for Insect Physiology and Ecology (ICIPE), Nairobi, Kenya. He has been a member of the Nigerian delegation to the CBD and a member of the IUCN Commission on Environmental Law and Co-chair of its Specialist Group on the Implementation of the CBD. He is a specialist legal adviser at the Secretariat of the International Treaty on Plant Genetic Resources for Food and Agriculture. He has also consulted widely for national institutions, international organizations and bodies as well as donors, including Bioversity International (formerly IPGRI), the FAO Commission on Genetic Resources for Food and Agriculture, and the Secretariat of the CBD.

Maria Julia Oliva is a legal consultant on intellectual property-related and other issues for the UNCTAD BioTrade Initiative. She is also one of the lead researchers in the Trade and Environment Research Group at the University of Geneva Faculty of Law. She sits on the board of directors of IP-Watch and is a member of the IUCN Commission on Environmental Law. Previously, she served for several years as Director of the Intellectual Property and Sustainable Development Project at the Center for International Environmental Law (CIEL). She earned an LLM degree in environmental law from the Northwestern School of Law at Lewis and Clark College, USA, and a law degree at the University of Mendoza in Argentina.

Tasmin Rajotte is the Quaker Representative for the Quaker International Affairs Programme (QIAP) in Ottawa, Canada. She has been the primary developer and executor of the work on intellectual property rights since QIAP's inception in 2001. She has a master's degree in environmental studies and has worked in the field of sustainable agriculture, food security and environment for a number of years.

Pedro Roffe is Intellectual Property Fellow at the International Centre for Trade and Sustainable Development (ICTSD). A former staff member of UNCTAD, Geneva, he has also been a consultant to Corporacion Andina de Fomento (CAF), Economic Commission for Latin America and the Caribbean. His work has focused on intellectual property, foreign investment, transfer of technology-related issues and international economic negotiations. He has contributed to several UN reports on these issues and to specialized journals.

Geoff Tansey is a writer and consultant. He helped found and edit the journal Food Policy, has worked on agricultural development projects in Turkey, Albania and Mongolia and co-authored the prize-winning book The Food System: A Guide. He has consulted for various international organizations and was senior consultant for the intellectual property and development programmes of the Quaker United Nations Office, Geneva, and Quaker International Affairs Programme, Ottawa, from their inception until 2007. He was also a consultant for DFID for the first phase of the UNCTAD-ICTSD TRIPS and Development Capacity Building Project from 2001 to 2003. In June 2005, he received one of six Joseph Rowntree 'Visionaries for a Just and Peaceful World' Awards, which provide support for five years. He is also a member and a director of the Food Ethics Council.

Acknowledgements

We are immensely grateful to a large number of people who have contributed in various ways to publication of this book. It has been a long process in which we have sought feedback throughout the development of the book. This process involved: many one-on-one consultations and discussions with people involved with food, agriculture, biodiversity and intellectual property issues from a variety of backgrounds, including staff in a range of international organizations; dialogues at different stages of the book; and a very broad peer review process. The first dialogue was hosted by the Centre for Rural Economy at the University of Newcastle, UK. The second dialogue was hosted by the Quaker International Affairs Programme (QIAP) in Ottawa. The final dialogue was held in Geneva and was hosted by the Quaker United Nations Office. We are also grateful to the participants in, and farmers we met through, the international gathering 'From Seeds of Survival to Seeds of Resilience' in Ethiopia in November 2006.

We received rich feedback from a wide range of reviewers and had very concrete, insightful and stimulating discussions in the dialogues. At the risk of missing some people out we would specifically like to thank all of those who took part in the dialogues and reviewed some or all the chapters, including: Frederick Abbott, John Barton, Terry Boehm, Sara Boettiger, Eric Chaurette, Carlos Correa, Susan Crean, Soma Dey, Carol Dixon, Caroline Dommen, Andrew Donaldson, Tewolde Berhan Gebre Egziabher, Peter Einarsson, Harriet Friedmann, Felix FitzRoy, Michael Gollin, Jonathan Harwood, Corinna Hawkes, John Herity, Lionel Hubbard, Brewster Kneen, Ted Lawrence, Richard Lee, Carlo Leifert, Lucie Lemieux, Sarah Lieberman, Niels Louwaars, Philip Lowe, Andrew MacMillan, Tom MacMillan, Ron Marchant, Duncan Matthews, Christopher May, Tracey McCowen, Eric Millstone, Patrick Mulvany, Davinia Ovett, Barbara Panvel, Ditdit Pelegrina, Jeremy Phillipson, Veena Ravichandran, Dwijen Rangnekar, Chris Ray, Jack Reardon, Tim Roberts, Wayne Roberts, Chris Rodgers, Eric Ruto, Josh Sarnoff, Nicola Searle, Dalindyabo Shabalala, Devinder Sharma, Lucy Sharratt, Carin Smaller, Jim Sumberg, Steve Suppan, Awegechew Teshome, Carl-Gustaf Thornström, Gary Toenniessen, Ruchi Tripathi, Rob Tripp, David Vivas-Eugui, Joachim Von Braun, Kathryn Wilkinson, Hironori Yagi, Neil Ward, the Secretariat staff of several intergovernmental organizations, and Geneva-based WTO and WIPO negotiators.

We are, of course, also deeply indebted to the contributors for sharing their knowledge and insights (and who have stuck with us through the lengthy process). We also thank Sanda Wiens, the QIAP assistant, who assisted in: coordinating the logistics for the dialogues; developing the database for the peer review process; developing the list of organization resources and references; and editing and formatting the draft manuscript. We also pay tribute to the staff at Earthscan for their support and help throughout, in particular Rob West, Alison Kuznets, Hamish Ironside and Gudrun Freese.

This book would not have happened without the support of the Canadian Quakers through the Quaker International Affairs Programme and funding from the International Development Research Centre in Canada as well as support from their officers, in particular Jean Woo, Brian Davy, Bill Carman and Rob Robertson. We would like to thank the Joseph Rowntree Charitable Trust, which, through their Visionaries programme, provided support for some of the time of one of the editors, and the Dutch Ministry of Foreign Affairs, which, through the Quaker United Nations Office (QUNO), provided additional support for QIAP. We are particularly grateful for help from Martin Watson and David Zafar Ahmed at QUNO.

Finally, but not least, we were nourished throughout the process by the support, faith and unwavering love of our Quaker committees, colleagues and families, in particular Norman de Bellefeuille and Kathleen Tansey, as we endured tight timelines, time zones, late nights and the joy of a newly born baby during the making of this book. To everyone, a heartfelt thank you.

Acronyms and Abbreviations

Part I
A Changing Food System

Food connects us all. Yet the oft-repeated pledges to create a well-fed world in which hunger is abolished are still words, not reality. What has changed since the 1990s is the creation of new global rules made in different negotiating fora by groups and ministries dealing with different interests. These are reshaping the framework in which people working in the food system operate. It is a system in which different actors vie for power and control over the area that they work in, seeking to minimize or offload the risks they face and maximize or optimize the benefits they get.

Part I of this book provides a brief guide to the contemporary food system, the range of actors and interests in it, the tools they seek to use for control, and the increasingly important role of laws, rules and regulations, not just nationally but globally. Next, it outlines the basics of 'intellectual property' and then briefly examines the growing importance of rules on patents and other forms of intellectual property in shaping future food systems and certain issues surrounding these.

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1
Farming, Food and Global Rules

Geoff Tansey

This chapter first gives a brief overview of today's dominant food system in which four key words – power, control, risks and benefits – are seen as vital for the major actors in the system. It discusses the dynamics of the system and then provides a brief background to the legal fiction that is intellectual property – patents, copyright, plant variety protection, trademarks, and so forth – and associated concerns as global rules on it continue to grow. Finally, the chapter looks at the growing role of intellectual property in food and farming and the concerns surrounding this.

Introduction

Serious doubts have been raised about the long-term viability of the industrial farming model that is spreading from the industrialized world to other countries. Yet the long-term viability of farming is central to ensuring food security for everyone on this planet (Box 1.1). Many now call for more ecologically sustainable approaches to farming built around biodiversity and ecology. Yet others, sure of humankind's inventive capacity or responding to their industry's interests, promote further intensification and industrial approaches to farming as the way forward. Thus the future direction of farming is highly contested (Lang and Heasman, 2004).

What is clear is that there are serious flaws in a food system that globally leaves more than 850 million people undernourished and over 1 billion overweight (300 million of them obese). Some 2 billion people also suffer from vitamin and micronutrient shortages. Undernutrition in pregnant women and young babies can have irreversible effects for life, while obese people's lives are threatened by diet-related noncommunicable diseases such as diabetes and heart attacks.

For decades, governments have made fine commitments to end hunger and deal with malnutrition, notably at the World Food Summit held at the UN Food and Agriculture Organization's Headquarters in Rome in 1996 (Box 1.2). They have also recognized, at least since the first global conference on the environment in Stockholm in 1972, that the environmental impact and consequences of human activity on the planet are fundamental to our survival. Yet it took almost 20 years before the central role of biodiversity as the basis for healthy ecosystems was addressed internationally (see Chapter 5).

Agricultural biodiversity, which has been developed through the creative activity of farmers over thousands of years (Chapter 6),

and is a necessity for food security, was discussed in the 1980s and 1990s. Concerns over genetic erosion and the continuing loss of the many varieties of plants important for human survival led to a major conference of the UN Food and Agriculture Organization (FAO) in 1996 and a Global Plan of Action to combat the loss of plant genetic diversity. Unfortunately, similar losses of animal genetic diversity are only now beginning to be addressed (Box 6.6) and action on both is far from adequate.

Another recent change has been the rapid extension of a legal system (patents) developed to encourage innovation in inanimate objects into the area of living organisms. This was led by the US in the 1980s. It is linked to the commercial application of insights from a major revolution in our understanding of biology that allows new techniques such as genetic engineering and its application in medicine and agriculture in particular. For some, the whole idea of extending patents into the living world is intrinsically wrong. For others, problems only arise should there be adverse consequences. The push to extend patents has not only come from commercial interests in biology but also from developments in information science and the ability to digitally encode and manipulate all kinds of information.

In a world with global markets, enterprises and problems, national responses and rules are no longer sufficient to tackle sensitive food, environmental and economic issues. New global negotiating processes have led to a range of new treaties on trade, biodiversity, and plant genetic resources for food and agriculture which were influenced by the concerns of some countries about patents and other forms of intellectual property (IP).

New institutions, new challenges

In the 21st century, new institutions producing global rules are reshaping the framework in which people concerned with food operate – from smallholders and farm families to global corporations. However, because of the political weight which they command in developed countries, the latter have a disproportionate impact in shaping the increasingly changing global rules within which different actors in the food system have to operate.

Some key questions arise from these changes: What will the long-term impact of these global rules be? Whose interests will they serve? Will they help make the food system more functional, in reducing all forms of malnutrition, from under- to over-nutrition, in an ecologically sustainable manner? But to address these we need an understanding of just what the rules are, how they arose and what may be done with them in the future. This book provides a guide to some of the global rules that:

• govern trade, in particular those that link trade rules to those on patents, copyright, trademarks and other forms of IP. These privilege some to the detriment or exclusion of others, in theory for the social and economic benefit of all (Chapters 2, 3 and 4);

• aim to conserve and promote the use of the enormous biodiversity on the planet and ensure the sharing of the benefits from using this (Chapter 5); and

• make special provision for agricultural biodiversity in the field of plants (but not yet that of animals), dealing with its unique characteristics as a way of safeguarding future food security globally (Chapter 6).

Different interests have been driving the various negotiations on these rules, which have also led to the creation of new global institutions. Perhaps the most important of these is the creation, in 1995, of the World Trade Organization (WTO), which came out of the Uruguay Round of trade talks begun in 1986 under the General Agreement on Tariffs and Trade (GATT). The key difference between the WTO and existing UN organizations – specialized agencies like the World Health Organization (WHO) and the FAO or that dealing with the Convention on Biological Diversity (CBD), which administratively is part of the UN Environment Programme (UNEP) – is that the WTO has a binding dispute settlement mechanism backed by sanctions. This means that countries that fail to follow its rules face real consequences, which is not the case for most other international bodies, except the UN Security Council.

When the WTO was set up, it brought agriculture fully under the trade regime for the first time, as well as introducing rules on plant and animal health (sanitary and phytosanitary standards) and IP. IP rules were introduced into the WTO against the wishes of developing countries, however, and with relatively little involvement of most stakeholders in developed countries. Instead, they were promoted and initially drafted by a small group of transnational actors from four major industries – film, music, software, and pharmaceuticals and biotechnology (Drahos, 1995; Drahos and Braithwaite, 2002; Matthews, 2002; Sell, 2003). This group saw that in global markets they needed global rules on IP if their business model was to survive and they were to capture the benefits arising from exploitation of new technological opportunities. Importantly, the inclusion of IP rules in the WTO meant that IP was introduced into agriculture for the first time for many countries, since the WTO rules require the patenting of micro-organisms and some form of plant variety protection through the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).

One problem here is that these global-level negotiations take place in different international bodies, are carried out by differing government departments – such as environment, agriculture, commerce, patent offices and trade – and are hard for many stakeholders to understand or influence. It is difficult for low-income and smaller countries to participate in them effectively, because of both the need for special expertise and the high costs. This complexity often makes it difficult to get coherent policies across the different areas (Petit et al, 2001). So, although more and more institutions/treaties/agreements/regimes are required as agricultural, environmental and trade systems become ever more global, problems arise when rules and regimes overlap (requiring legal interpretation and negotiation). Furthermore, when regime remits are similar, but their provisions benefit some more than others, then states 'shop around' for the most beneficial possible outcomes of membership in different regimes.

Before discussing IP further, we need first to look at the changing food system.

Food Policy and a Changing Food System

Enormous challenges face us in ensuring a sustainable, secure, safe, sufficient and nutritious (in other words healthy), equitable and culturally appropriate diet for all, which should be the aim of food policy and a functional food system (Tansey and Worsley, 1995). Yet few governments have consciously tried to link the different elements of national policy to food and produce coherent food policies. One reason is complexity. Food policy is about what influences the set of relationships and activities that interact to determine what, how much, by what method and for whom food is produced and distributed, and by whom it is consumed. It deals with the food economy, which is a subset of the wider economy (OECD, 1981).

Humans are very adaptable and can have a wide variety of diets, as the variety of peasant cuisines, developed from what was locally available, shows. Furthermore, these diets have changed, absorbing new plants and animals and yielding new products as humans have spread across the planet, as empires have waxed and waned, as the rich have sought new delicacies, and as the poor have sought to have what the rich had. Wherever we are today, the food we eat could have been different, and probably was in the past. What we eat has a history, and that history is not simply a history of food but a history of culture and society.

Food is a basic necessity for life. We eat foods, not nutrients, and different foods fulfil a wide variety of roles in our lives, not simply in terms of sustenance but physiological, social and cultural. We use food for reward, for pleasure, to express status, culture and religious preference, and so on. In spite of the overall adequacy of food availability in the world, however, there continue to be huge differences in the amount and quality of food that people eat, as discussed above.

Food comes from our environment – people have to grow or gather it, or fish or hunt it. Continued food supplies depend upon maintaining a healthy environment and upon having a diverse range of plants and animals available to us to make it possible to keep breeding varieties that can cope with the diseases, changes in climate and other stresses that farmers, fishers and herders face. That is why agricultural biodiversity is crucial. And it means that ecological wellbeing is a core requirement for our future food supplies, and that new technological development needs to take it into account (ETC Group, 2004).

Actors and interests

There are many different groups of actors involved in bringing the food we eat to our mouths (Tansey and Worsley, 1995), unless we live a mainly self-provisioning life. Most of the actors found in industrialized countries – farm input suppliers, farmers, food processors and manufacturers, distributors, workers and caterers – may all be in the same household in largely smallholder farming communities. Even then, there is probably a need to have other input suppliers for fuel or fertilizer, traders to sell surplus to, and retailers or wholesalers to buy from. For most town and city dwellers and people in the wealthier countries, or wealthier people in poorer countries, what they can get to eat depends largely on others. The various actors in the food system are engaged in a struggle over who will have power and control over the production and supplies of food, and how the benefits and risks arising from different activities will be distributed. Increasingly, the money made out of food does not go to farmers but to those who supply them and who are intermediaries between them and our mouths.

Fortunately, we do not need that much food to live healthily. A healthy diet can be obtained from a relatively simple mix of a staple source of carbohydrate supplemented with some sources of protein and fruits and vegetables – which the great cuisines of the world tend to be based on – although some communities, for example the Inuit, have even more specialized diets linked to special environments. Our limited need for food, however, poses a problem for businesses working in food in a market economy. To prosper they need to expand their business, especially if they are publicly quoted companies. This limited demand puts greater pressures on food-related businesses than many others. Think, for example, of a pair of shoes, a radio, a CD, a TV or a car. You can increase your consumption of these many times – you can have 10 pairs of shoes, 50 CDs, three radios, two TVs and two cars – without any physical harm coming to you. But you cannot increase your basic food intake two-, three- or fourfold without serious harm – as indeed we are seeing in the obesity epidemic spreading around the world.

The pressure on businesses increases the competition between them, the desire to find new technologies to give them an edge over others, to look for ways to increase the productivity of the money, land or people used in the business, and to diversify from what they started doing into other activities, products – especially high value products – or markets.

Trends and tools

Three key trends have affected how the food system – indeed the economic system more generally – develops. First, a growing economic concentration of power in any of the sectors – from farm input suppliers such as agrochemical, energy or equipment companies to traders, retailers and caterers – means that fewer and fewer firms control more and more of the market. Box 1.3 illustrates this for the agriculture input industry, an area where changing IP rules is important in fuelling the trend. The increasingly concentrated market power enables the ability of these bigger players to affect prices, reduce competition and set standards within a sector (Murphy, 2006; Vorley, 2003). A recent development has been that:

the plant genetics industry is now heavily concentrated in a half-dozen major firms that hold substantial numbers of key patents on germplasm. They also have IP coverage of the related enabling technologies. … [T]he control of patents and seed distribution networks exercised by these companies has substantially increased the barriers to entry for new firms in the field of germplasm development. (Falcon and Fowler, 2002, pp204–205).

Second, there is a shift from local to national, regional and global markets, with some larger players increasingly seeing the world as a global market and organizing to be active in it. And the third trend is to look for ever better, more certain, more effective tools to help control the risks faced by the different actors and to secure the desired benefits. The various tools for control used are science and technology, information, management, and laws, rules and regulations.

Science and technology

While science and technology are often talked of together, they are not the same. It is not necessary to have a correct scientific understanding of something to develop a technology that works. Trial and error, treating things as black boxes, where doing X produces Y, without understanding exactly why, is sufficient to develop many forms of technology. Sometimes, however, a revolution in scientific understanding is needed to conceive of new technologies. Such was the shift Einstein brought to physics when he showed matter and energy were interchangeable, which opened up the possibilities of nuclear power. Another such revolution has occurred in biology, with the understanding that living organisms grow and develop through the expression of genes, encoded in DNA, which are built from the same four building blocks. This understanding makes it possible to conceive of ways to re-engineer living organisms and gives rise to genetic engineering and other aspects of modern biotechnology, such as cloning, genomics and marker-assisted breeding. It is now possible, in principle, to mix genes from any species with another and possibly synthesize new life forms (synthetic biology) although the desirability of doing so and the long-term effects are hotly debated. These possibilities are leading to different actors seeking to redesign many living organisms of commercial value in agriculture. The questions arising concern whether they should do so; who carries the risk and gets the benefits if they do; and the possible longer-term effects and implications.

Information, management and law

Information is another tool different actors use to affect food habits. Some types of information may be designed to inform or educate, while other forms are used to market or advertise, or in promoting public relations or lobbying for specific policies. The spread of global media, broadcasting similar images across the world, helps fuel product globalization and reinforce brand images, usually protected by trademarks or copyright.

Understanding and influencing consumer behaviour has become a major interest of retail businesses. Today, cognitive science is increasing understanding of human motivations and behaviours, and insights from this may help bigger players to use ever more subtle ways to influence people's attitudes and buying habits. Information technology and data processing methods – which affect the capacity both to carry out basic scientific procedures, such as gene sequencing, and to manage businesses and supply chain logistics and profile customers – are also widely used by many of the bigger actors.

Other management tools, such as logistics, may be used to determine the supply systems most advantageous for the businesses involved. For example, the UK's biggest food retailer and an increasingly global player, Tesco, invested heavily in supply chain logistics in the 1980s. In industrialized countries, work organization has shifted from craft-based, small-scale production to a large-scale, mass-production phase, which now often uses just-in-time manufacturing and stocking techniques. In the US, business methods themselves are patentable.

Information and management activities tend to be the preserve of firms and governments and to focus on children, other businesses or consumers – the people who influence or make decisions about what to buy in market economies. Yet unlike the major actors in the system – the input suppliers and processing, retailing and catering companies that are best able to use information and management tools – consumers are unorganized individuals. Consumers can have a significant effect on policy, however, when they take action en masse, such as stopping buying beef because of fears over mad cow disease (BSE), or work through consumer groups. Otherwise firms can simply open a new niche in the market to cater for a specific group of consumers' tastes or concerns.

Marketing, public relations and advertising go together to influence people's behaviour. Much effort and expense goes on these tools, which are more easily used by the larger players in promoting their particular product, approach or image.

When consumers act as citizens, however, they may be able to shape the environment in which all the other actors operate through influencing the choice of government and the laws, rules and regulations governments put in place to balance the range of interests in society. When laws are developed and applied nationally there is a greater chance that a range of people affected by changes can have a say in shaping such changes. This becomes more difficult as rule-making processes become more global, with rules being set by international intergovernmental organizations. For just and balanced outcomes, both nationally and internationally, it is important that rule-making processes do not become captured by vested interests.

One set of rules that has moved from being set nationally in national economic interests to being promoted globally as minimum standards that all countries must adhere to are those on IP, and it is to this that we now turn in more detail.

A Legal Fiction – Intellectual Property

Origins of IP

So where does IP come from? As P. Drahos points out, '"Intellectual property" is a twentieth-century generic term used to refer to a group of legal regimes [such as patents, trademarks and copyright] which began their existence independently of each other and at different times in different places' (Drahos, 1996, p14). These different forms provide creators and inventors with legal protection from someone copying or using their work or invention without permission. Some protect the intellectual knowledge behind technological innovations (patents) and others protect creative works such as books, films and music (copyright). They also include trademarks such as those connected with branded goods, geographical indications like Stilton cheese and champagne, and trade secrets such as the formula for Coca-Cola or the parent lines of hybrid plants. These different forms of IP are an invented kind of intangible property – yet just as valuable as oil, gold or land for some. Societies construct the rules governing them through political processes dependent on power plays for their outcomes (May, 2000). They are not like a natural phenomenon such as gravity waiting to be discovered. In today's knowledge-based market economy, control of so-called 'intellectual property rights' (IPRs) helps in controlling markets and influences the distribution of wealth and power (Box 1.4).

The ordinary concept of property itself is not a natural phenomenon but a socially constructed one. For some indigenous peoples or religious groups, for example, the idea of ownership of land or water, a fundamental in most current ideas of tangible property, is literally 'non sense' and does not figure in their way

of seeing the world. The idea of creating an intangible form of property, which developed in the past few centuries in Europe, is 'entirely a legal construction' (May, 2002). In other words, human beings, at least those with power in society, make it up and then seek to justify it

(Box 1.5). To be socially acceptable in European society, for example, the notion of IP also required a society secularized enough to accept that creative genius was a personal trait, not a divine gift, that intellectual products had to have a commercial value in their own right and that private rights had to be distinguishable from those of sovereigns (Lesser, 1997).

Historically, IP rules have been a matter of national decision making based on national economic interests. Countries with a national interest in having strong patent rules, because they produced a lot of technology, for example, did create such rules, those without such a capacity did not. Countries copied technologies from each other, selectively offered patent rights, for example to domestic inventors over foreign nationals, or simply did not allow any patents on some products such as medicines (Chapter 3). International treaties in patents and copyright originated in Europe and the US and countries signed up to them if it suited them. Some did not fully adopt the existing international rules. For example, until the mid-1980s, the US protected the domestic printing industry by denying copyright to foreign authors unless their books were printed in the US.

Even today, patents still must be applied for in each country, although there are mechanisms to enable companies to apply for them in many countries at the same time through the World Intellectual Property Organization (WIPO – see Chapter 4). WIPO is an international institution where many international discussions and negotiations about IP take place, but it is no longer the only one, following the introduction of the Trade-Related Aspects of Intellectual Property Rights Agreement (TRIPS) as part of the WTO package of Agreements (Chapter 2). In WIPO countries are free to sign up to each of the various agree­ments individually. It was this that posed a problem for those industries and countries that wanted to safeguard their economic interests with a global IP regime and led them to seek to introduce minimum standards for IP rules through the WTO.

Concerns about IP

The strengthening and extension of the IP regime has led to a range of concerns over the impact of the new IP regime on low- and middle-income countries, especially the effects on health, in particular concerning access to medicines, such as AIDS drugs in Africa or basic diagnostic techniques for screening for breast cancer. Similar concerns about the effects of IP on access to seeds and knowledge needed for research and development are being raised by a range of academics, policymakers and NGOs such as GRAIN and the ETC Group. These include IP's effects on who does what research and development, how and whether smallholder farmers can continue farming, especially in low- and middle-income countries, and the increasing concentration of power in the various sectors of the food system (Chapter 8). Other concerns are over the way in which these rules were agreed and extended globally and the continued pressures for developing countries to adopt ever higher standards of IP protection (Chapter 7). A central issue is whether the new IP regime has the balance of interests right between those who receive the privileges IP affords and those negatively affected by it. Another issue is the need for the IP rules to be embedded in a broader regulatory regime that can curb the tendency to monopoly and abuse (such as cartels) that IP can give rise to:

The immediate impact of intellectual property protection is to benefit financially those who have knowledge and power, and to increase the cost of access to those without. (IPRs Commission, 2002, p47)

The UK government recognized the complexities and concerns about IP in its White Paper on International Development in 2000 and set up a Commission on Intellectual Property Rights (IPRs Commission) to consider 'how intellectual property rules might need to develop in the future to take greater account of the interests of developing countries and poor people'. The Commission reported to the Secretary of State for International Development at the Department for International Development (DFID) in September 2002 and noted that:

Developing countries … negotiate from a position of relative weakness. … The immediate impact of intellectual property protection is to benefit financially those who have knowledge and power, and to increase the cost of access to those without. (IPRs Commission, 2002, p47)

It also noted that:

Developing countries should generally not provide patent protection for plants and animals … because of the restrictions patents may place on use of seed by farmers and researchers. … [T]he extension of intellectual property protection does carry the risk of restricting farmers' rights to reuse, exchange and sell seed, the very practices which form the basis of their traditional role in conservation and development. (IPRs Commission, 2002, pp66–68)

The Bigger Debate on IP

To have …

The proponents of a strong global IP regime argue it provides the necessary incentive, proper reward and required security for investment in R&D to produce life-improving innovations. Historically, two main moral and philosophical arguments for rewarding creative and innovative people have been used. One stems from the view of the 19th-century German philosopher Hegel – that an idea belongs to its creator because the idea is a manifestation of the creator's personality or self. The other is drawn from the work on real property by John Locke, the 17th-century English philosopher – that the usefulness of physical or natural objects came about through human effort and that those who had expended that effort had a moral claim to exclusive use of those objects (May, 2000).

Today, in practice in industrialized countries, the rationale for protecting the intangibles created by IP is essentially utilitarian – with the utility focused on promotion of innovation on the assumption this bring benefits for all. For example, knowledge about how to make something, unlike a physical object such as a piece of bread, can be used or consumed by one person without limiting its use by others. Sharing knowledge with others, then, does not reduce the amount you have, unlike sharing a piece of bread. However, it might reduce the advantage you may have had if you were the only one to know something or were allowed to exclude others from using what you know. The problem is that while the widest possible dissemination of new knowledge makes for the greatest economic efficiency, if everybody is free to use new knowledge, inventors have little incentive to invest in producing it. The various forms of IP stop that sharing (usually temporarily) by transforming knowledge from a shared public good into a private good. In other words IP creates scarcity where there need be none. This gives the holders of IP enhanced market power and permits the use of monopoly pricing through which they can recoup their expenditure in research and development. Creative minds and innovative firms thus have an incentive to engage in inventive activities. The IP regime, then, plays an important role in underpinning private sector-led innovation, and also in the ability of firms to establish and maintain market power.

This argument provides the main rationale for the protection given by patents, copyright, plant breeders' rights and other types of IP. However, the various forms of IP in different countries differ in terms of the subject matter that may be eligible for protection, the scope (what can be protected) and duration (length of time) of protection, and possible exemptions to exclusive rights. This reflects the fact that they are a concession granted by a society, through the laws it constructs, which advantage a specific group for broad social goals (increasing creativity and inventiveness) and try to balance the interests of producers and users of intellectual works.

The EU clearly sees IP playing a role in helping to secure its members' economic interests in the development and application of modern biotechnology. Among the measures proposed by the European Commission in a 30-point action plan is creating a 'strong, harmonized and affordable European intellectual property protection system, functioning as an incentive to R&D and innovation' (CEC, 2002, p25) as one support for utilizing the full potential of biotechnology and strengthening the European biotechnology sector's competitiveness.

… or not to have?

In an extensive study reviewing the main justifications for IP – whether for reward to authors or to promote innovation – political scientist Chris May argues that their real purpose today is protecting financial investment. In some countries this is identified with the national interest. May notes that, when negotiating to put new IP rules into the WTO in TRIPS, the US saw them as a way 'to retain its competitive advantage in the global system' (May, 2000, p119). This is not seeing them as a way of transferring up-to-date technology but rather of maintaining the gap between those countries with technology and those without to ensure national advantage. However, May argues that the gap is legitimized by using IP justified on the basis 'not of advantage, but of the rights of the individual knowledge innovators'. This view of the expanding IP regime as one of the ways of preventing development is put more graphically by University of Cambridge economist Ha Joon Chang, who talks of 'kicking away the ladder' (Chang, 2002).

James Boyle, a professor of law at Duke Law School, argues that the effects of a global IP regime will be widespread and not as beneficial as its proponents suggest. He helped draft a declaration which suggested that:

The blandishments of the international information industries notwithstanding, more intellectual property rights may actually mean less innovation, less heterogeneity in culture and environment and a less informed world of public debate. (Boyle, 1996, p197)

This is basically because they may underpin a highly concentrated market structure dominated by large firms that use these rules to inhibit others from threatening their position. IPRs, he argues, are being used as part of a new round of enclosures in what were formerly the 'global commons' – including genetic information encoded in the genes of people, plants, animals and micro-organisms (Boyle, 2001). This is part of what Peter Drahos sees as a trend towards 'proprietarianism – a creed which says that the possessor should take all, that ownership privileges should trump community interests and the world and its contents are open to ownership' (Drahos, 1996, p202).

Drahos warns against thinking of IPRs as rights. Instead we should think of them as privileges:

Unlike real property law, intellectual property law posits rights in abstract objects … IPRs are rule-governed privileges that regulate the ownership and exploitation of abstract objects in many fields of human activity … [they] are liberty-intruding privileges of a special kind … they promote factionalism and dangerous levels of private power. From the point of view of distributive justice, their scope should be limited … there are strong reasons for supporting private property rights, but we should do so in a contingent, consequentially-minded way … guided by a philosophically defensible view of the role of property in social life and democratic culture. (Drahos, 1996, pp1, 5)

Drahos sees stronger, global IPRs resulting in a new form of 'feudalism'. This is because they will alter social relations in ways that mean individuals never 'own' entities like software or seeds. Instead purchasers are only licensed by their corporate rights holders to use them in very limited ways and are excluded from socially important acts normally associated with real property – the ability to lend, share, give away or sell (Drahos and Braithwaite, 2002). Thus the issues surrounding IP go far beyond the focus here on food and agriculture.

Not rights but privileges

It would be a more accurate reflection of reality if we stopped using the term 'intellectual property rights' and instead talked of 'business monopoly (or exclusionary) privileges'. Using more accurate language would also avoid any confusion with human rights discussions (see Chapter 7). The language of privilege, even if these privileges are enshrined in law rather than custom, helps make clearer the political and power-based mechanisms that lead to some being privileged over others. They also make clearer their instrumental purpose, which is geared to market-based creative and inventive business operation across a wide range of fields, among which agriculture has become a recent target.

It may also make it easier to unpick the rather mystifying terminology of IPRs. This terminology has conflated what used to be called 'industrial property', such as trademarks, patents and industrial designs, with copyright. This latter is connected, especially in Europe, with notions of the moral rights of authors to be identified with their work and not have that work distorted.

Patent problems

Of particular concern to many is the extension to developing countries, through the WTO TRIPS Agreement (Chapter 3), of minimum requirements on patenting. This issue is made more complicated because a system that was developed for innovation in inanimate objects has, in some countries, been extended to cover living organisms and parts of them. Patents are supposed to provide benefits to their owners and society at large. Patents are granted in the US on the basis that there has been an invention of something new, useful and non-obvious; in Europe on the basis of being novel, having industrial application and involving an inventive step. A major concern today even in the US and EU is that the meaning of these words has been devalued and poor quality patents are being granted for 'inventions' that lack novelty and an inventive step.

Moreover, in reality, 'the basic patent bargain works only in theory. In practice, both sides cheat', argues Professor of Information and Organization at Sheffield University, Stuart Macdonald:

Most obviously, the patent affords protection only when the patentee can afford to enforce his rights, which may mean that the poor have no protection at all. … And if society cheats in not providing the protection the inventor has a right to expect from the patent system, the inventor cheats too. Only in theory does the inventor provide society with the information of invention: in practice, he discloses the information required by the patent system, not the information required by society to replicate and develop his invention. (Macdonald, 2001)

This raises questions both about the justice of the system, if it is not equitable in its functioning, and about whether its application fails to meet the objectives for which it is designed. Currently, patents are also very unevenly distributed globally, as 'industrialized countries hold 97 per cent of all patents worldwide' (UNDP, 1999, p68).

US economist Keith Maskus writes:

There are legitimate reasons to be concerned about the highly protective standards that have emerged recently in the US and the EU. These laws and judicial interpretations provide broad patent protection for software and biotechnological inventions. They also promote extensive rights in the formulation of databases, which could have a negative effect on scientific research. It remains to be seen whether such standards tilt the balance within those jurisdictions toward the private rights of inventors and away from the needs of competitors and users. It is not too early to claim that they are inappropriate for developing economies and net technology importers. (Maskus, 2000, pp237–238)

Clear evidence that the patent system has stimulated the development of new products and technologies, which otherwise would not have been developed, is only available for a few sectors, such as pharmaceuticals – and even here basically 'for those diseases where there is a large market in the developed world' (IPRs Commission, 2002, p33). The rationale for patents in the pharmaceutical industry, for example, is that the exclusive rights they confer allow the industry to charge high prices for products and so recoup its research and development (R&D) costs. Once drugs go off-patent and generic suppliers enter the market, prices fall, often dramatically, making medicines more accessible to the poor. In pharmaceuticals, however, where most R&D is commercially led, the industry has not produced drugs aimed at diseases of the poor, nor at those with relatively few sufferers, without some form of government incentive. Much basic research is also done by government and then turned over to companies for commercialization. In effect, consumers pay for it twice, first through taxes that fund government research and then via high prices for drugs under patents that fund corporate activities. These problems have led to much debate in the health sector about the patent regimes' effect on access to medicines, especially in developing countries (MSF, 2004; Roffe et al, 2006).

In other sectors, patents are sometimes considered to have anti-competitive effects: they serve to secure and strengthen the position of market leaders and limit the entry of new competitors. Indeed, they were used in this way in the 19th century (Jenkins, 1975). In the extreme, they may actually slow the pace of innovation if a dominant firm possesses a powerful pool of patents that limits the ability of other firms to further improve existing products and technologies and acts in an anticompetitive way.

Although policymakers have sought to limit the adverse effects of patents through revised IP legislation, competition policy and other business regulations, the anti-competitive implications of patents remain a cause of concern, for example patent pooling and cross-licensing between a few firms in effect creates a cartel keeping others out. Such concerns have regained momentum with the emergence of patents on biotechnology products and processes that cover fundamental research tools, human genes, genetically engineered plants and other living organisms.

IP in Food and Farming

IP pervades today's industrialized food system. The Gowers review of IP in the UK gave the example of a jar of a well-known brand of coffee:

The contents of a jar, the lid and seal may be protected by patents. Registered and unregistered design rights can also protect the lid and shape of the jar. Copyright can protect the artwork in labels, and trademarks can protect the shape of the jar, labels, colours used and brand names. (Gowers, 2006, p1)

From consumers …

Broadly speaking, the various kinds of IP are used more by some firms than others, often based on whether they are selling to a final consumer or producing for intra-firm trade or farmers. Trademarks, geographical indications and trade secrets are widely used by firms and actors dealing with the final consumer. The use of trademarks is often linked to other tools for control, such as brand advertising. Greater efforts to protect brands and increase market share are increasingly likely. In 1993, the chairman of Unilever, the Anglo-Dutch multinational, called brand equities 'the most valuable items in our stewardship' and saw 'the power of our brands as the engine of long-term growth' (Tansey and Worsley, 1995, p115). During that year, the company spent almost 12 per cent of turnover (£3284 million) on advertising and promotional investment. In 2000, Unilever announced plans to dispose of three-quarters of its 1600 brands to focus on just 400 around the world. In 2002, its chairmen said, 'We are focused increasingly on driving the growth of our leading brands and dealing with other brands in ways which create value for shareholders' (Burgmans and Fitzgerald, 2002). Other global companies with many fewer or single brands also spend heavily on advertising and marketing. In 2006, for example, over US$2.5 billion was spent advertising Coca-Cola while McDonald's selling, general and administrative expenses amounted to over $2.3 billion. These figures are much more than the annual budget of the WHO and around three years of the FAO's budget.1 Yet, as research by the Food Commission in the UK illustrates, there is an inverse relationship between what is advertised and what is recommended as a healthy diet (Dalmeny et al, 2003).

As the reach of the market and mass marketing techniques, especially in an increasingly globalized market, go further into lowand middle-income countries, so too will the major actors make use of various forms of IP as part of their business development strategy. In urban societies served by multiple retailers – supermarkets are also spreading rapidly in many rapidly urbanizing developing countries today – advertising and media images become more important and unless farmers or producers have a major brand they will not get their goods on the retailers' shelves. Normally, only the top two or three brands of a given product actually do.

For some products, a combination of widely advertised branded products (which are based on trademarks) and trade secrets – the recipe for Coca-Cola being the most famous – are used. For others, producing a product in a particular way or region, a designated name, linked to the region and method of production, provides a marketing tool that allows them to capitalize on their uniqueness. These geographical indications (another form of IP) are of considerable importance in some foods, for example Roquefort cheese or Parma ham. Such designation normally comes out of a well-established activity that has national recognition and produces products sought after by consumers. The ability of small producers to find markets for their often unadvertised products or to develop new geographical indications which they have little capacity to promote is very different from those whose supply chains lead into nationally, regionally and globally promoted branded products.

… to producers

If gardeners buy a rose or other ornamental plant from a garden centre, they may find a note attached saying they are not allowed to take cuttings or otherwise propagate the plants they buy. The same may be the case for some farmers and vegetable growers, with restrictions placed on their saving seed. This is possible because the holders of another form of IP, in this case plant breeders' rights or, in a few places, patents, can legally exclude people from doing things they might otherwise have done, like replanting seed saved from a previous crop that they have grown.

For farmers in the wealthier parts of the world who buy seed, fertilizer, feeds, agrochemicals and equipment, and for researchers developing new breeds, varieties and products for them to use, the key forms of IP are plant breeders' rights (Chapter 2) and patents (Chapter 3). These forms of IP will increasingly influence control of food production in a world where genetic engineering and commercial breeding becomes more prevalent. Where farmers in developing countries are the focus of seed sales, however, it seems that commercial horticultural seed producers consider trademarks to be as important as plant variety protection, at least according to the author of a recent study (Louwaars, personal communication, 2006), which examined the impact of plant variety protection on the breeding and seed sector in developing countries (Louwaars et al, 2005). Trade secrets are potentially also important as they are used to protect hybrids, with the parent lines kept secret, but these are difficult to enforce in most countries. While these forms of IP have been used in the urbanized, industrialized countries for a few decades, they are still very new in many low- and middle-income countries.

Patent power

Patents are very important for the development of agrochemicals and many controversial developments in modern biotechnology (Barton, 2003; Box 1.3), especially genetic engineering and now nanotechnology. Agrochemicals have long been patentable, but it was only recently – in 1980 – that a genetically-engineered microorganism was first allowed to be patented in the US, following the Diamond v. Chakrabarty Supreme Court case in 1980 (Dutfield, 2003a, 154ff). Within a few years plants and animals, and parts thereof, such as genes, were also allowed to be patented in the US (although a special form of plant patent on asexually reproducing plants had been available in the US since the 1930s). Once patent law was extended to cover living organisms in the US, companies were then able to move into and work in this area as they would now be able to capture the benefits by excluding others from using such organisms through the patent system. It also led to pressures in other industrialized countries to allow similar extensions in their patent law, although many restricted patentability to genetically engineered organisms, not allowing naturally occurring ones to be patented.

The potential of genetic engineering to open up new market opportunities all over the world fuelled an expansion of private sector interest in agricultural research in industrialized countries. This happened at the same time as public sector-financed R&D in agriculture declined and moved away from research of practical benefit to farmers. Instead, public sector-financed R&D increasingly focuses on more basic research that produces results that can only be used by the larger corporate players that have R&D facilities (Millstone and Lang, 2003, p40; see also Chapter 8).

The firms involved in the private sector-led transformation of the basic inputs into agriculture want a set of rules and regulations to permit them to secure benefits from their R&D and avoid costs. If they can, companies naturally want to stop others from copying – or buyers reproducing – their new products. This can be done in two ways. One is by legal means, through patent and other IP rules. This has led to a clash between real property rights of farmers about how they use their land and the rights of patent holders (Box 1.6). The other means is technological. Breeding hybrids, for example, which do not reproduce truly and lose their yield characteristics in subsequent generations is one such method (Lewontin, 1993). This creates a kind of 'economically sterile' seed and also promotes a planned obsolescence approach to variety production (Rangnekar, 2002a). Breeders also use trade secrets protection to keep the parents of the hybrids secret, thus making it difficult for competing breeders to get a similar cross onto the market. Another approach is to attempt to develop technologies that will stop seeds germinating or specific

traits being activated without a purchased input – so-called genetic use restriction technologies (GURTs), also dubbed 'terminator' and 'traitor' technologies (Chapter 5, Box 5.5).

As the various competing businesses developing products and processes in this area make growing use of IP, such as patents and plant breeders' rights (PBRs), to protect their investments, there has been more litigation to settle disputes (Barton, 1998). Without these forms of IP, while research would undoubtedly go on, the way and speed with which its results were developed and commercialized would almost certainly be different.

The potential of genetic engineering to manipulate plants which could be patented drew new players into the business of seed production, largely from the chemical and pharmaceutical industries. They have invested billions of dollars over the past two decades in agricultural biotechnology R&D and want to see returns on this investment, which means that the crops they have developed have to be grown commercially sooner rather than later. These companies have a long history of using patents as business tools and require some form of control over their rights to the research tools they have developed and rights to prevent reuse of their products, such as seeds, without their permission or further payment. They were one of the important interest groups keen to allow for patenting of living organisms and are supporters of the main players pushing for stronger IP rules internationally.

There are growing concerns on the part of some researchers and NGOs that exposure to the full range of IP tools being wielded by the large firms, which are sophisticated in their use thereof, may have a major adverse impact on people's livelihoods and food security in developing countries in particular. In part this is felt to be a result of increased corporate control, undermining livelihoods and local farming systems and promoting undesirable consumption patterns (ActionAid International, 2005). When IP tools are combined with other requirements by buyers (for example identification of place of origin), the pressures for exclusion of small-scale suppliers can become even greater. Of particular concern to many is the pressure to allow patents on everything, everywhere.

Going Global

Extending IP rules globally will have wide-ranging implications for the future control of food, many of which are still to be felt. It will affect access to seeds, knowledge and anything else protected by IP. Yet access to and exchange of genetic resources is the basis of agriculture. At the same time as IP regimes are expanding, other international regimes, concerning biodiversity and agriculture biodiversity, are still being worked out in practice on the ground and in conference halls around the world. It is to these different regimes that we turn in Part II, before returning to look at the experiences and implications of these regimes for our future food security, however that is understood (Box 1.7).

Whatever people try to achieve locally in managing their food and farming, they need to know about the mix of global rules because these rules will increasingly constrain local and national action. Moreover, changes in one area tend to affect others. Part II of this book examines these new rules, the negotiations that surround them, how they interconnect and the complex web they create.

Part II
The Key Global Negotiations and Agreements

International agreements often seem hard to understand and legalistic. In reality, they are very difficult to arrive at and involve complex, long negotiations among states with different interests. It is the outcome of these machinations that produce agreements that come to have legal force and affect all our lives.

The following chapters discuss several key texts to show how various international agreements arose and some of the power plays and interests that lay behind them. Key points from the agreements are discussed, along with how they relate to each other and the complex connections that are developing. The aim is to inform and so help facilitate wider participation in shaping the rules that govern us and affect our food future.

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2
Turning Plant Varieties into Intellectual Property: The UPOV Convention

Graham Dutfield

The first international treaty bringing intellectual property (IP) into agriculture was drawn up in Europe to harmonize and support existing national systems that give commercial plant breeders' rights over the plant varieties they breed, and to promote the system in other countries. This system of plant breeders' rights was a newly created alternative to the US approach of allowing plant patents, itself a special regime designed to protect vegetatively reproduced ornamental and fruit varieties. Since the TRIPS Agreement, all WTO Members must provide some form of IP protection for plant varieties, but it is up to them how to do it. This chapter examines the development of plant breeders' rights and some issues that arise from them today.

Background and History

For almost all of human history, farming and crop improvement were carried out by the same people and in the same places, by farmers and indigenous peoples on their own land. The separation of the two activities is very recent, starting in the 19th century. In this chapter I explain what scientific breeders do (see also Chapter 6) and then briefly trace the history of this separation between farming and breeding, which began in Europe and North America, where the first professional breeders emerged, and farmers abandoned or were forced out of breeding as an activity. This separation is an ongoing process in many developing countries and in some areas has hardly even begun.

Since Neolithic times, farmers have set aside some of their harvested seeds for replanting. They selected such seeds, whether consciously or unintentionally, on the basis that the plants producing them possessed desirable traits such as high yields, disease resistance, or drought or frost tolerance. Over the generations, this practice resulted in ever increasing quantities of locally adapted varieties known as 'landraces', 'folk varieties' or 'farmers' varieties'.

Breeding as a science

This situation changed in North America and Europe from the late 19th century as the profession of farming became a separate one from seed production. The emerging seed producers started to select from the existing materials to increase their share in the market. This commercial crop improvement remained merely empirical and experimental but with a growing scientific basis in mathematics applied to selection methods. Very soon after the 1900 rediscovery of Mendel's insights into the laws of heredity, scientists sought to apply genetics to crop improvement. This led to the directed development of 'pure lines' of self-pollinating crops. Pure lines are uniform, breed true to type and contain consistent and identifiable traits that can be transferred to other plants. According to two experts on the politics of modern agriculture, Robin Pistorius and Jeroen van Wijk (1999), 'while Mendelian breeding allowed for a controlled mixing of genetic characteristics, pure line breeding offered a practical method to "fix" them in succeeding generations'.

Breeding new plant varieties is a laborious and time-consuming process. It takes about 7–10 years to get from the first cross to the marketable variety. The first task is to determine the objectives of the breeding programme. One obvious goal is to produce varieties with higher yields, but there are many other possible objectives such as the development of varieties with added or improved characteristics such as pest resistance, disease resistance or drought tolerance, compatibility with inputs such as fertilizers and pesticides, and improved consumption or food-processing characteristics. A major challenge for breeders is to respond both to the requirements of varying farming conditions and to the need to develop varieties that can be sold widely. Furthermore, they increasingly have to respond to the ever-changing demands of conglomerate seed and chemical companies, food processing companies and supermarket chains.

The basic conventional technique is known as 'crossing and selecting', which involves crossing two or more parent lines or varieties with desirable traits to produce multiple offspring. Of these, the best plants are selected and allowed to breed again. Again, the best ones are selected for breeding and the process is repeated a number of times. After 8 to 12 generations, an improved variety is produced that breeds true and is ready to be planted by farmers.

But breeding is rarely this simple. For one thing, a new variety may be derived from 50 or more parental lines. For another, a variety used in the breeding programme may be the source of only one desirable trait and many undesirable ones. So how does the breeder incorporate this single trait into his or her new variety while excluding the others? Very simply, let us call plants from the parent line or new variety into which the single trait is to be introduced 'Group A' and call members of the 'donor' plants (which could well be a wild or semi-domesticated relative) 'Group B'. These Group B plants are the source of just one desirable trait, among many unwanted ones, for which as little as one allele (a DNA sequence that codes for a gene) may be responsible. For the breeder to transfer this allele without the undesirable traits, he must first cross Group A and Group B plants and then 'back-cross' those offspring containing the trait with plants from Group A. This is repeated through the generations, selecting plants that retain the trait and back-crossing them with Group A plants. In time, the proportion of genes from Group B plants contained in the offspring goes down in conventional selection systems from 50:50 in the first generation to a negligible figure.

These approaches generally work well with crops like wheat, rice and sorghum that self-fertilize. These tend to be genetically stable and consequently breed true. But, as with humans and animals, inbreeding can be deleterious for cross-pollinators such as maize, pearl millet and cruciferous crops like cabbages and oilseed rape. This is not such a problem for plants that can reproduce asexually, such as vines, apple trees and potatoes, where the genetics are fixed through this reproduction system: once a new variety has been bred, it can be multiplied through vegetative forms of propagation, whether cuttings, grafts or tubers. But for cross-fertilizing seed crops, the breeder must find another approach.

Maize breeders in the early 20th century came up with a solution by applying the rediscovered principles of Mendelian genetics. George Shull, a breeder working at a US government research centre, managed to induce the characteristic of what he called 'heterosis' in the corn plants, resulting from his cross-breeding of inbred lines. This phenomenon, commonly referred to as 'hybrid vigour', is manifested in heightened yields. But because they are hybrids, the offspring cannot breed true and the maximum yield enhancements thus last only for a single generation. The additional advantage that hybrid varieties provide a uniform crop compared to the open-pollinated populations became apparent with large-scale agricultural mechanization. So while farmers stand to benefit from seeds providing this hybrid vigour, they need to buy seeds at the beginning of every planting season to enjoy equally productive future harvests. If farmers replant the seeds from hybrid crops, the resulting plants tend to be 'segregated', reflecting the characteristics of the grandparents. This necessity to buy seed was and continues to be a boon for the seed companies, which could correct a major risk factor in seed production, namely that seed markets are generally anti-cyclic, in other words after a good harvest – when the seed producer has good stocks – farmers save their seed, whereas the demand for seed is high when seed production conditions have been poor. Hybrids create a stable seed market.

The hybrid route to the breeding of better seeds is generally assumed to be a very good thing for farmers and for the development of the seed industry, but sceptics argue that the massive investments in the development of hybrid varieties that were made in the 1920s and 1930s could have been allocated to breeding based on more conventional techniques using open-pollination that would have achieved similar yield increases but without preventing farmers from being able to replant their harvested seeds (Lewontin, 1993).

Other breeding techniques, such as tissue and cell culture development, have also been used for several decades. These enable scientists to regenerate large numbers of plants that are genetically identical and free from disease. These techniques do not replace conventional breeding but can improve its efficiency. More recently, molecular biology introduced new opportunities in breeding, either to make conventional breeding more efficient and effective (marker-assisted selection) or by moving foreign genes into the breeding materials (genetic engineering), not just from other plant species, but sometimes from completely different forms of life. For example, scientists have succeeded in inducing insect resistance in crops like corn and cotton by inserting genes from a soil microbe called Bacillus thuringiensis (Bt) that is toxic for certain insects. These techniques include direct gene transfer into tissue cultures using bacteria or viruses as carriers of the foreign DNA, and such devices as high-velocity 'gene guns' which shoot DNA-containing 'bullets' into cell nuclei. The new science of genomics is being used to identify useful genes and the plants which contain them.

The emergence of the modern seed industry

During the 19th-century westward expansion of the US, the government sought to encourage settlement. One way to do this was to entrust the farmers themselves with the selection, breeding and multiplication of seed. To this effect, first the Patent Office, and then the US Department of Agriculture (USDA), provided farmers with free seed packets for them to experiment with. At the time the seed industry was small and insignificant. Farmers used these seeds and those introduced by the immigrants arriving in the US to breed varieties adapted to suit their own needs and the local ecological conditions. The number of such varieties increased enormously. Later these farmer-bred and selected crop varieties formed the basis of the public and private sector breeding programmes.

Cary Fowler (1994) argues that the separation of farming from breeding, the undermining of the customary practice of seed saving in the case of hybridized crops and the commodification of the seed cannot be explained by advances in plant breeding science and technology alone. When scientifically bred seeds came onto the market, subsistence agriculture had largely been replaced by commercial farming anyway. Mechanized harvesting and the consolidation of landholdings had made seed selection non-viable compared to the greater convenience of purchasing mechanically-cleaned seed from dealers. And, since most farmers were no longer improving seeds themselves, the attraction of selecting and replanting was declining even before scientifically bred varieties became widely available.

In 1890, 596 US firms were involved in commercial seed production. Having formed a business association called the American Seed Trade Association (ASTA) a few years earlier, they were becoming active in defending their interests. One of ASTA's early campaigns was to stop the government from providing farmers with seeds. This failed for lack of support from the public and Congress, many of whose members sent seed packets to constituents. However, during the first two decades of the 20th century, the government increasingly sent seeds only of the most common varieties to farmers, while passing on the more exotic germplasm to the government experimental stations and colleges. A later campaign by ASTA from the First World War onwards was to oppose the saving of seed by farmers.

Shortly after the First World War, the US Secretary of Agriculture decided that the USDA would henceforth support research aimed at the development of hybrids and ending farmer participation in breeding programmes. The Secretary's son, Henry A. Wallace, was sent by his father on a tour of experimental stations and recommended his father appoint a devotee of hybrids as head of research. Henry subsequently founded the Pioneer Hi-Bred Seed Company and was himself appointed Secretary of Agriculture in 1932 (Lewontin, 1993, pp55–56).

The implications of the emergence of corn hybrids for private-sector breeding cannot be underestimated. Several of the world's major 20th-century seed companies first came to prominence through their successful breeding of hybrid corn varieties. Many of these old seed companies are now owned by companies like Monsanto, Syngenta, Dupont and Delta & Pine Land, which was itself bought by Monsanto in 2006. According to Jack Kloppenburg (1988), 'hybridization is … a mechanism for circumventing the biological barrier that the seed had presented to the penetration of plant breeding and seed production by private enterprise'. This was well understood by some of the pioneering scientists involved in the development of hybrid corn, who realized that the absence of genetic stability in the harvested seed gave them a kind of virtual IP protection which they could back up by using trade secrecy law. Indeed, the determination of companies to prevent unauthorized access to their inbred parent lines could be very intense. Unfortunately for breeders (and presumably for farmers), though, hybridization does not work for some of the most economically important crops such as wheat. Clearly, this presents problems for breeders. Plants are self-reproducing. With no law to prevent it, there is nothing to stop farmers from replanting harvested seed, or even multiplying seed and selling it in competition with the breeder (assuming this would be more profitable for them than selling harvested produce). This is where IP rights come in.

As opposed to the US situation of expansion by settlers into new land for cultivation, albeit into land often taken from the indigenous peoples, virtually all the cultivable land in 19th century Europe had been farmed for a very long time. Most of the major European crops whose origins were exotic, like wheat, rye, maize, potatoes and tomatoes, had become well-established and integrated into local farming systems for centuries or even millennia. Although some crops were vulnerable to devastating diseases due to widespread genetic uniformity (most notoriously potatoes), European farmers developed a huge range of varieties over the centuries to suit local conditions. European governments generally did not find it necessary to encourage farmers to breed new varieties themselves as in the US case.

Agricultural intensification took place under different circumstances and with different aims. In Europe, land was in short supply but labour was plentiful, rather than the other way round as was the case in the US. Farms tended to be smaller and did not lend themselves so easily to mechanization. Attempts to increase productivity came through other techniques to grow more food on existing land.

Introducing new species and formal experimental breeding were carried out first by wealthy landowners, and from the second half of the 19th century by small family seed firms. These firms descended from farmers that made it their main business to provide seed for other farmers and who then started breeding programmes to better meet the requirements of their customers. As in the US, in the early 20th century public research institutions and universities were also carrying out breeding work, which benefited the emerging private plant breeding sector. By the time of the Second World War, Germany, the US, The Netherlands, Sweden and the Soviet Union were the leading plant breeding nations for field crops. In countries like Britain and France, government-supported research during the first half of the century was often directed to tropical agriculture rather than temperate-zone crops. This was to develop and improve the production of certain crops in the colonies. Both countries reoriented their breeding efforts as these colonies became independent, and France subsequently developed the world's second largest private seed sector. Britain, though, had few seed firms until the 1960s, and most breeding, especially of major crops like wheat, was left to the public sector. This situation has changed, but the seed sector is still much smaller than that of France – the birthplace of the UPOV Convention.

From the 1960s, the use of modern high yielding varieties of major food crops like rice and wheat became increasingly common in developing countries, particularly in Asia and Latin America. Nonetheless, the extent of private sector involvement in breeding for developing country farmers was quite modest during that era. Since then, though, US and European plant breeding companies have become much more active in the developing world. This is happening at a time when public sector agricultural research investments targeted at the needs of developing country farmers, especially those with few resources, are considered by many to fall well short of what is needed.

As already mentioned, several economically valuable crops do not lend themselves to hybridization. For these, breeders needed to find other means to control the use and production of their varieties. This is where lack of IP protection became an issue several decades ago, leading to the development of an international regime designed specifically to protect plant varieties whose seeds could otherwise be easily saved, replanted and sold, namely the UPOV Convention. Before looking into the particular solution devised, Table 2.1 places the discussion in context by presenting the legal and technological problems and solutions faced by companies seeking to capture the rewards from their investments in plant improvement according to how the plants normally reproduce (Dutfield, 2007).

Table 2.1 Appropriating plant breeding innovations: Legal and technological problems and solutions

The UPOV Convention

The form of plant variety protection (PVP) under UPOV, otherwise known as plant breeders' rights (PBRs), is commonly described as a 'patent-like' regime. In fact, this is not quite accurate, as an understanding of the background to the UPOV Convention should clarify. Admittedly, though, the increasing strength of the PVP right of recent years is beginning to approximate that of the patent.

The UPOV Convention was adopted in Paris in 1961 and entered into force in 1968 once it had been ratified by three countries – The Netherlands, the UK and West Germany. It was revised slightly in 1972 and more substantially in 1978 and 1991. The 1978 Act entered into force in 1981, the 1991 Act in 1998. All members, with the exception of Belgium, are parties either to the 1978 or the 1991 Acts. New members are required to accept UPOV 1991, although exceptions allowing membership on the basis of the 1978 Act have been made.

The Convention established an organization called the Union Internationale pour la Protection des Obtentions Végétales (UPOV). The official English translation is International Union for the Protection of New Varieties of Plants. UPOV has a close association with the World Intellectual Property Organization (WIPO – see Chapter 4) to the extent that the latter organization's director general is also secretary general of UPOV. As of April 2006, the Union had 60 member states plus the European Community. Unlike WIPO, UPOV is a lean organization with a small office in Geneva. The supreme decision-making body is the Council, which consists of representatives of each member and has one ordinary session a year.

The existence of UPOV can be attributed largely to two international organizations. One is the Association Internationale pour la Protection de la Propriété Industrielle (International Association for the Protection of Intellectual Property) (AIPPI), which was founded in 1897 and consists of activist legal practitioners, patent attorneys, trademark agents, scientists, engineers and corporations. The other is the Association Internationale des Selectionneurs pour la Protection des Obtentions Végétales (International Association of Plant Breeders) (ASSINSEL).

At the 1952 AIPPI Congress, the delegates, partly at the urging of ASSINSEL, discussed the issue of plant varieties. There was general agreement that plant varieties should be protected in some way. The most concrete ideas came from the German AIPPI group, which submitted a detailed technical report arguing that both patents and an alternative system should be available to breeders. As the authors, Franz and Freda Wuesthoff, explained, it is a normal requirement of patentability that other people skilled in the art should be able to reproduce the invention described in the specification (Wuesthoff and Wuesthoff, 1952). That is to say, following the instructions provided in the specification should result in the invention as claimed. But, as they explained, when it comes to plant breeding, being able reliably to reproduce the new variety from the beginning is difficult because it depends on natural processes over which breeders do not have total control and which are to some extent random. However, repeating the whole breeding process is not necessarily important or even necessary. What really matters is that the new plant that has been brought into existence can be directly propagated. For sexually reproducing plants, this means that they must breed true so that the offspring are identical to their parents.

As the two authors saw it, the solutions were to change the patent system by taking a permissive view of the reproducibility requirement and to extend the range of patentable subject matter in those countries where plants were not considered to constitute inventions, and to develop a new or modified IP system for the more incremental plant breeding-derived innovations. They considered that patents in their present form would accommodate a certain amount of innovation in plant breeding and should be made available to breeders, but that for many new varieties, workable IP protection would require a relaxation of the novelty and inventive step requirements so that varieties reflecting incremental improvements on existing ones and that were already known about could nonetheless be protected.

The AIPPI Congress could not reach a consensus on the means of protection, and a 1954 Congress also failed to do so. One of the main reasons was that some of the patent lawyer members of the AIPPI opposed the patenting of plant varieties on the grounds that doing so would stretch basic patent law concepts like inventiveness to the point of undermining the credibility of the patent system (see Chapter 3).

In the event, ASSINSEL's members decided at their own Congress in 1956 to abandon the patent route and to call for an international conference to consider the possibility of developing a new international instrument for protecting plant varieties. ASSINSEL requested the French government to organize what became the International Conference for the Protection of New Varieties of Plants. The Conference, which convened in May 1957 in Paris, established the basic principles of PBRs that were later incorporated into the UPOV Convention. Only European governments were invited to participate or attend as observers. A Committee of Experts was set up to:

• study the legal problems arising out of the protection of the breeder's right as defined by the Conference;

• give as precise formulations as might be appropriate of the basic technical and economic principles laid down by the Conference; and

• prepare the first draft of an international convention for submission to a later session of the Conference itself.

The Committee met twice before appointing a Drafting Group to develop a legal text. One of the important issues the Committee had to decide upon was whether the convention would be incorporated into the general framework of the Paris Convention, which dealt with indus­trial property, primarily patents, or whether a separate convention was necessary. It decided in favour of the latter, but recommended that the new office administering the convention should work closely with the Bureaux Internationaux Réunis de la Protection de la Propriété Intellectuelle (BIRPI – see Chapter 4), the forerunner to WIPO.

The second meeting of the International Conference for the Protection of New Varieties of Plants took place in November 1961, with 12 European countries invited along with BIRPI (now WIPO), the FAO, the European Economic Community, the Organisation for Economic Co-operation and Development (OECD), the AIPPI, ASSINSEL and two other business associations: the Communauté Internationale des Obtenteurs de Plantes Ornementales et Frutières de Reproduction Asexuée (CIOPORA) and the Fédération Internationale du Commerce des Semences (FIS). Since then, ASSINSEL, the FIS and the new International Seed Federation (ISF), along with CIOPORA and the International Chamber of Commerce, have played key roles in shaping the evolution of the UPOV Convention through its various revisions. UPOV was created and shaped by plant breeders for plant breeders and they have a strong sense of ownership of the Convention. Public interest organizations have had minimal involvement. The UPOV office is an active proselytizer of plant variety protection around the world and strongly defends the Convention from those who question its value to developing countries or its continued relevance in the age of biotechnology.

Just as the UPOV Convention was being adopted, the Council of Europe was actively working to promote the harmonization of patent rules, procedures and principles among the Western European countries. One key result of this was the signing of the 1963 Convention on the Unification of Certain Points of Substantive Law on Patents for Invention. The Convention had to accommodate wide differences in national patent rules relating to pharmaceuticals, food, agriculture and horticulture while encouraging states to harmonize their rules within a realistic time-frame at the level of the most expansive rights available at that time in any one country. Accordingly, parties were not required to grant patents in respect of '(b) plant or animal varieties or essentially biological processes for the production of plants or animals'.

The terms 'essentially biological' replaced 'purely biological' from an earlier version of the text. The Council's Committee of Experts on Patents, which was responsible for drafting the convention, changed the wording to broaden the exclusionary language to embrace such 'essentially biological' processes as varietal selection and hybridization methods even if 'technical' devices were utilized to carry out the breeding processes. The Convention's text reflects, as of course does UPOV, the decision in Europe made in the late 1950s to keep plant breeding out of the patent system. There is much similarity between the wording of the Convention and that of the European Patent Convention and the TRIPS Agreement (Chapter 3).

The Convention's Provisions and Issues Arising

Compared to some other important international agreements on intellectual property, such as TRIPS and the Paris Convention for the Protection of Industrial Property, the UPOV Convention's provisions are extremely detailed and specific. They deal with the plant varieties covered, the requirements for protection, the length of the protection term, the scope of protection, breeders' exemption, farmers' privilege, and whether or not both patents and PVP can be held on the same variety. They have been subject to several revisions since 1961. In order to join the Union, countries are supposed to have PVP regimes already in place, and these are normally scrutinized by UPOV to see that they are in harmony with the Convention's provisions.

The most substantial revisions took place in 1978 and 1991; these are discussed and compared below. Note, however, that the French word obtention in the name of the Union and the Convention is significant since it indicates that rights can be acquired not just by those who breed new varieties in the classic sense of creating new varieties by crossing and selecting sexually reproducing plants, but also by those who improve plants based on the discovery and selection of mutants or variants found in a population of cultivated plants. Thus UPOV 1991 clarifies that a breeder is a person 'who bred, or discovered and developed, a variety'. This is consistent with the original intent of the Convention to protect varieties that may not entirely be attributable to the application of scientific breeding. At the same time, however, it represents a divergence from patent law, which professes not to allow mere discoveries to be protected. Table 2.2 compares the key provisions of UPOV 1978 and 1991 and patent law.

What qualifies for protection?

To be eligible for protection under the UPOV system, plant varieties must be new, distinct, stable and uniform:

• To be new, the variety needs to be so not necessarily in the absolute sense, but not to have been offered for sale or marketed, with the agreement of the breeder or his successor in title, in the source country, or for longer than a limited number of years in any other country.

• To be distinct, the variety must be distinguishable by one or more characteristics from any other variety whose existence is a matter of common knowledge anywhere in the world, implicitly including among traditional farming communities. Compared to UPOV 1978, the requirement in the most recent version has been relaxed somewhat. It does this by dropping the phrase 'by one or more important characteristics' after the word 'distinguishable'.

• To be considered as stable, the variety must remain true to its description after repeated reproduction or propagation. In other words it must have a certain level of uniformity which avoids the change of the variety through genetic drift.

The uniformity requirement also shows the specific nature of the UPOV system, since this requirement cannot practically be the same for species with different ways of reproduction; self-fertilizing species can be much more uniform than cross-fertilizing crops. Therefore the uniformity requirement is made relative instead, in other words a new variety should be uniform when compared to the varieties of the same species. This means that when plant breeding techniques were refined, the uniformity requirement gradually increased, making it beyond the reach of farmer-breeders who may select in landraces, which are not genetically uniform, to develop new varieties. Unlike patents, there is no disclosure requirement. Instead, applicants are required to submit evidence that the variety meets the protection requirements (in the US, for example) or to submit the plant material for which protection is sought to the responsible governmental authority for testing to ensure that the above eligibility requirements have been met.

While it is logical to require that protected varieties are genetically uniform, there are dangers with widespread planting of crop varieties that are genetically similar to each

Table 2.2 Comparison of main provisions of UPOV 1978/1991 and patent law

other. Kloppenburg (1988, p93) provides a good illustration of what can go wrong when there is 'genetic vulnerability accompanying dependence on a narrow base of germplasm'. In 1970, '15 per cent of the corn crop in that year was lost to an epidemic of southern corn leaf blight. Corn prices rose 20 per cent, and losses to consumers and farmers totalled some US$2 billion.'

What is a 'plant variety', and how may it be distinguished, for the purposes of IP protection, from a 'plant'? This is very important given the increased application of genetic engineering to crop research and the fact that in some jurisdictions, plants are patentable but plant varieties are not. The original 1961 version of the UPOV Convention defined 'plant variety' as including 'any cultivar, clone, line, stock or hybrid which is capable of cultivation'. The 1991 revision contains a more detailed definition, according to which a plant variety is:

a plant grouping within a single botanical taxon of the lowest known rank, which grouping, irrespective of whether the conditions for the grant of a breeder's right are fully met, can be:

• defined by the expression of the characteristics resulting from a given genotype or combination of genotypes;

• distinguished from any other plant grouping by the expression of at least one of the said characteristics; and

• considered as a unit with regard to its suitability for being propagated unchanged.

Scope of protection

UPOV 1978, which several countries are still contracting parties to, defines the scope of protection as the breeder's right to authorize the following acts: 'the production for purposes of commercial marketing; the offering for sale; and the marketing of the reproductive or vegetative propagating material, as such, of the variety'. The 1991 version extends the scope of the breeders' rights in two ways. First, it increases the number of acts for which prior authorization of the breeder is required. These include 'production or reproduction; conditioning for the purpose of propagation; offering for sale; selling or other marketing; exporting; importing; and stocking for the above purposes'. Second, such acts do not just concern the reproductive or vegetative propagating material, but also encompass harvested material obtained through the illegitimate use of propagating material and so-called essentially derived varieties.

Breeders' exemption

However, the right of breeders both to use protected varieties as an initial source of variation for the creation of new varieties and to market the resulting varieties without authorization from the original breeder (the 'breeders' exemption') is upheld in both versions. This represents a major difference with patent law, which normally has a very narrow research exemption. Many plant breeders are concerned about the effects of patents on free access to plant genetic resources, including varieties bred by others. One difference between UPOV 1978 and UPOV 1991 is that the latter extends rights to varieties which are essentially derived from the protected variety. So the breeder of PVP-protected variety A has the right to demand that the breeder of variety B secure his or her authorization to commercialize B if it was essentially derived from A. The main idea here is that breeders should not be able to acquire protection too easily for minor modifications of extant varieties produced perhaps through cosmetic breeding or genetic engineering, or free-ride without doing any breeding of their own, problems that the increased application of biotechnology in this field appeared likely to exacerbate.

PVP and patents

Beyond resolving these particular issues, but related to them, the provision on the scope of protection was also intended to ensure that patent rights and PVP rights operate in a harmonious fashion in jurisdictions where plants and their parts and genes are patentable and access to these could be blocked by patent holders. Such a practice would undermine one of the main justifications for PVP protection, which is that breeders should be able to secure returns on their investments but without preventing competitors from being able freely to access breeding material. An example here might be useful. Consider the case of a PVP-protected variety, variety A, and a patented genetic element owned by another company (Jördens, 2002, p6). The owner of a patent on this genetic element is free to use A to produce his or her variety B and, in the absence of the essential derivation provision, place B on the market with no obligations to the owner of A, despite the fact that B differs from A only in the addition of the patented genetic element. However, the owner of A would need a licence from the producer of B to use the patented genetic element in the breeding of further varieties. In such a situation, then, patents can have the effect of blocking the breeders' exemption that PVP rights normally provide. The PVP-issuing office, however, will not itself determine whether a variety is essentially derived from an earlier one. This will be left to the courts. So far, only one court, in The Netherlands, has been called upon to make such a determination and it found in favour of the defendant (Fikkert, 2005). According to the court, the general rule is that distinguishable varieties are normally independent, the essentially derived variety (EDV) provision being an exception to this rule that ought to be construed narrowly. Given that one of the two varieties at issue differed in several ways in shape and form from the variety from which they were allegedly essentially derived, the exception was not applicable. As for the other variety, no convincing case had in any case been made that it was an EDV, besides which the Community Plant Variety Office made no mention of its similarity to the already registered original variety or found any grounds to investigate such a possibility.

In the EU, the 1998 EC Directive on the Legal Protection of Biotechnological Inventions seeks to make PVP and patents operate more harmoniously by providing that where the acquisition or exploitation of a PVP right is impossible without infringing a patent, or vice versa, a compulsory licence may be applied for to allow for its use. If issued, the licensor party will be entitled to cross-license the licensee's patent or PVP right. Subsequent legislation in Germany and France restore the breeder's exemption in that it explicitly allows breeders to use genetic materials that include patented components for further breeding. When the new variety contains the patented component, however, consent has to be sought for the marketing of that new variety; when the patented component is 'bred out' of the material, the patent holder has no rights on the new variety.

Farmers' privilege

There is no reference in the 1978 version to the right of farmers to re-sow seed harvested from protected varieties for their own use (often referred to as 'farmers' privilege'). The Convention establishes minimum standards such that the breeder's prior authorization is required for at least the three acts mentioned above, namely the production for purposes of commercial marketing; the offering for sale; and the marketing of the reproductive or vegetative propagating material, as such, of the variety. Thus, countries that are members of the 1978 Convention are free to either uphold farmers' privilege or eliminate it. All UPOV member countries implemented the exemption for 'private and non-commercial use' under the UPOV Act of 1978 to include the re-sowing and in some cases the local exchange or sales of seed. However, this was not the case for ornamental crops in The Netherlands, where a stronger protection was deemed necessary. In the US this was interpreted very liberally, so that in practice sales of farm-saved seed were allowed provided that they contributed less than 50 per cent of total farm income. This resulted in large quantities of seed being 'brown bagged' to the detriment of the commercial interests of the breeder.

The 1991 version is more specific. Whereas the scope of the breeder's right includes production or reproduction and conditioning for the purpose of propagation (Article 14), governments can use their discretion in deciding whether to uphold the farmers' privilege which includes only the use of saved seed on the same farm (and thus excludes any type of exchange or sale of such seed). According to Article 15, the breeder's right in relation to a variety may be restricted 'in order to permit farmers to use for propagating purposes, on their own holdings, the product of the harvest which they have obtained by planting … the protected variety'. Even though the Act states that the legitimate interest of the breeder explicitly has to be taken into account, the seed industry generally dislikes farmers' privilege. The EC Regulation 2100/94 on Community Plant Variety Rights, which was adopted in 1994, restricts farmers' privilege to certain crops, and breeders must be remunerated through the payment of royalties unless the users of the farmers' privilege are small farmers, in which case they are exempted. Interestingly, the European Community's patent rules also require that farmers' privilege be provided and defined under the same terms as the above regulation. The US's PVP rules are less strict in this regard: seed saving must be restricted to the amount necessary for on-farm replanting, but it is not clear how the legitimate interests of the breeder are implemented since royalty payments on farm-saved seed are not required.

Length of protection and double protection

UPOV 1991 extends protection from at least 15 years to a minimum of 20 years. This later version is silent on the matter of double (that is, both patent and PVP) protection, whereas the 1978 version prohibited such double protection on the same variety. Allowing double protection without any restriction was to ensure the intellectual property practices of the US and Japan, which allowed such double protection, would be fully compliant with UPOV. Nonetheless, most countries, including all European countries, expressly forbid the patenting of plant varieties. In 1995, in Greenpeace v. Plant Genetic Systems NV, the European Patent Office's (EPO) Technical Board of Appeal ruled on an appeal against the upholding of a plant-related patent. The board determined that a patent claim for plant cells contained in a plant is unpatentable since it does not exclude plant varieties from its scope. This implied that transgenic plants per se were unpatentable because of the plant variety exclusion. Consequently, for the next four years, the EPO stopped accepting claims on plants per se. However, in December 1999, the EPO Enlarged Board of Appeal decided in Novartis that, while genetically modified plant varieties are unpatentable, 'a claim wherein specific plant varieties are not individually claimed is not excluded from patentability under Article 53(b), EPC, even though it may embrace plant varieties'. This reopened the door to the patenting of plants as long as the claims in the patent specification do not refer to individual varieties.

Changing membership

Until the late 1990s, the overwhelming majority of UPOV members were developed countries, reflecting the fact that in many developing countries, especially in Africa, private sector involvement in plant breeding and seed supply is quite limited. Moreover, in many of these countries small-scale farming communities are responsible for much of the plant breeding and seed distribution, as they have been for centuries. Consequently, until recently there would have been few domestic beneficiaries of a PVP system in these developing countries apart from the public institutes for agricultural research.

However, many developing countries are now joining UPOV. In many, if not most, cases, this is not because of any strong domestic demand for PVP, but because of their obligations under Article 27.3(b) of TRIPS (see Chapter 3) or trade agreements (see Chapter 7). The UPOV system is the only sui generis system for plant varieties that exists in international law and is currently being actively promoted worldwide by the organization itself, as well as by the US and the EU though bilateral free trade agreements that tend to require developing country parties to join UPOV. However, developing country WTO Members that prefer not to allow plant varieties to be patented do not need to join UPOV. In principle they can devise their own system without reference to UPOV's standards. Alternatively, they could simply use one of the UPOV Acts as a model but opt not to join the organization, an approach that many Asian countries currently follow, choosing to use the 1978 version of UPOV as a model, mainly because of the greater freedom to formulate farmers' privilege.

PVP versus patents

Despite the increasing membership of UPOV, the question arises of why breeders still tend to prefer PVP to patents, and also of whether this particular intellectual property right has a future. After all, patents provide much stronger legal protection (Table 2.2). Moreover, breeders nowadays tend to work not for small independent seed firms, but for large life science corporations that invest huge amounts of money in biotechnological research and hold massive patent portfolios. Probably the main reasons for this preference for PVP is the breeders' exemption, which allows them such broad access to breeding material, and their concerns that the patenting of biotechnological research tools may jeopardize this access. Breeders, especially those in smaller companies, also fear the complexity of rights in the patent system, compared to the simple 'one variety, one right' system of PVP, leading to complex legal battles for which they fear they do not have the financial or legal resources. This suggests that as long as there is profit-motivated plant breeding, PVP rights will continue to exist alongside patents, and sometimes in tension with them.

Critical Concerns

Concern has been raised that the UPOV system was drawn up mainly by European countries, and is designed to accommodate the specific characteristics of the capital-intensive large-scale commercial agricultural systems that generally prevail on that continent. As a result, it is often argued, the system is unsuitable for most developing countries. Among such critics, the current system of IPRs protection for plants has raised concerns over their impact on food security in three areas: (i) PVP and research priorities; (ii) the interests of poor farmers; and (iii) the availability of genetic resources for further breeding. Note, however, that, while a few studies have been carried out on the impacts of PVP in developing countries (see below), the overall effects of plant intellectual property in developing countries are difficult to discern conclusively and researchers find themselves having to rely to too great an extent on the experiences of developed countries.

PVP and research priorities

Does the UPOV Convention encourage breeders to investigate minor crops and to bring whole new species into cultivation? Empirical evidence casts doubt on whether PVP (as well as patents) does much to encourage investment in plant breeding except in just a few commercially important crop species such as wheat and soya bean and ornamentals, although UPOV's own studies are, perhaps unsurprisingly, much more positive about the overall impacts of PVP (UPOV, 2005a). Critics also argue that even if breeders did turn to neglected crops, many of the small farmers that grow them would not be better off if their freedom to use saved seed as they wished were diminished. In most developing countries a very large proportion of the farming population consists of smallholders, and for these people saving, selling and exchanging seed is common practice and essential for their survival.

Many smallholder farmers cultivate minor food crops that enable them to meet the nutritional needs of rural and urban communities much better than if major crops such as wheat, rice and maize alone were cultivated. In many parts of the world, farmers may grow more than 100 crop species and cultivated varieties. However, PVP does not encourage breeding related to minor crops with small markets. This is because the likelihood of good returns on breeders' research investment is small even with the legal protection provided by PVP. Rather, it encourages breeding targeted at major crops with significant commercial potential. Moreover, protected varieties of plants may not even be food crops. In Kenya, for example, from 1997 to 2003, out of a total of 611 PVP applications, 247 were for foreign-bred roses. This is not necessarily a bad thing, since such exports of cut flowers are a good source of foreign exchange, but some argue that the production methods used damage the environment and the health of the growers (War on Want, 2007).

It is conceivable, then, that PVP may contribute to a trend whereby traditional diverse agro-ecosystems, containing a wide range of traditional crop varieties, are replaced with monocultures of single agrochemical-dependent varieties, with the result that the range of nutritious foods available in local markets becomes narrower. Admittedly this trend is a global phenomenon whose beginning predates the introduction of PVP systems; nevertheless, it is one that the existence and increasingly widespread use of PVP may indirectly encourage.

PVP and smallholder farmers

In most developing countries a large proportion of the population depends on agriculture for employment and income. Many of these farmers are smallholders for whom the saving and across-the-fence and inter-community exchanging of seed are common practices. This is especially the case in countries and regions where neither the public nor private sectors play a significant role in breeding, producing or distributing seed. Although the UPOV system may allow on-farm replanting, its rules restrict farmers' freedom to buy seed from sources other than the original breeders or their licensees.

Seed companies argue in response that farmers do not have to purchase PVP-protected seed just because it is available. They point out that the farmers are free to continue cultivating seed that is not plant variety protected, including traditional local varieties, if they so wish, and that therefore their basic freedoms are unaffected by PVP. While this is likely to be true, traditional varieties are often disparaged and are likely to be excluded from government-approved seed lists that some countries maintain under their seed regulations. While finding non-PVP seed may not yet be a serious difficulty for developing country farmers, this situation may change. In some developed countries, it is becoming difficult for farmers to find non-PVP varieties of some crops.

Seed laws

PVP is not the only issue, as seed laws may sometimes unduly limit the choice of varieties that farmers are allowed to bring into commercial production. Seed regulations were introduced for very good reasons. From the late 19th century a number of European governments became alarmed about the unregulated nature of the seed trade and the extent to which poor quality seed got onto the market. This situation was problematic for farmers, legitimate breeders and governments, which had become concerned about the need to increase agricultural productivity. In the early decades of the 20th century, many governments responded first by establishing seed testing stations, and then by certifying seed. The latter also provided to a certain limited extent a kind of IP protection for breeders, and as such was a kind of barrier to market entry. Indeed, UPOV largely grew out of such seed certification regimes. In many developing countries, governments concerned about rural poverty and convinced, even if mistakenly, that traditional agriculture is unproductive support farmers in rural credit schemes by promoting particular crops and types of seed, such as hybrids, which tend to require expensive inputs and may not be suitable for the local agronomic conditions (see also Chapter 8, Box 8.9). Furthermore, seed aid is often used by providers as a way to promote the use of modern varieties that may not necessarily be the most appropriate ones to plant. As Sperling et al (2006) explain:

while formal sector varieties are referred to as 'improved' and the quality of the seed is certified, these varieties often yield poorly in many smallholder cropping systems. Such new varieties may not be adapted to the local agroecological conditions and farmers may not possess the management inputs (for example fertilizers and pesticides) crucial for their growth.

Seed saving, however, is not always a cost-effective option for farmers since saved seed deteriorates over generations. Moreover, seed is one among several agricultural inputs that farmers may have to pay for. Even poor farmers may decide to pay a higher price for better quality seed if they expect a bigger harvest to result.

IPRs and genetic resources for breeding

Plant breeders and other supporters of UPOV tend to stress the necessity of being able to freely access genetic material, including that which is IPR protected. This is why the UPOV Convention contains such a broad breeders' exemption. Patent law tends to have a much narrower research exemption, which is often limited to non-commercial scientific or experimental use. Moreover, while a protected plant variety is covered by a single title, plant-related biotechnological inventions are likely to be protected by a patent, in some cases by several patents. These patents may cover not just plants, but also seeds, genes and DNA sequences. The effect of patents is to restrict access to the patented 'products'. It has been argued that 'locking up' genetic resources with patents is a bad thing because innovation in plant breeding is cumulative and depends on being able to use as wide a stock of material as possible. This is a plausible concern and one that many plant breeders share with public interest NGOs such as GRAIN. It was to deal with this concern that the FAO International Treaty introduced a number of provisions; these are discussed in Chapter 6.

However, the restrictions on access to breeding material may have other causes than IPRs. For one thing, some countries have chosen to exclude certain categories of plant genetic resources they consider to be strategically important from the multilateral system set up under the International Treaty. Furthermore, some developing countries have been exercising their rights under the Convention on Biological Diversity (CBD – see Chapter 5) to regulate access to their genetic resources in ways that unduly restrict their movement. This may well be detrimental to long-term food security even in their own countries.

Research, development and ownership

Beyond these issues about how specific intellectual property rights privatize genetic material needed for breeding is the association of IPRs generally with the shrinkage of non-proprietarian public sector research, and the increased concentration of ownership of breeding material, research tools and technologies in the hands of a small number of giant corporations. While IPRs are not directly responsible for this shrinkage of public sector research, they do appear to contribute to this concentration effect. For one thing, the expense of acquiring large IPRs portfolios can operate as a barrier to market entry. For another, the advantages of owning lots of patents and PVP titles are such that large firms have an incentive to buy up or merge with rival companies that also own such rights (see also Chapter 8).

Are these trends a bad thing? One consequence is a reduction in the free circulation of breeding material. This may lead to a reduced level of welfare-enhancing breeding activity, especially if rights are asserted against the public sector. In addition, they may make public policymaking aimed at enhancing food security harder to put into practice. This is because it is much more difficult for governments to influence companies than the public institutions they partly or wholly fund. Cash-strapped governments, however, may have to reduce their research expenditures out of necessity, and the private sector can and sometimes does play a useful role in taking up the slack.

Empirical Evidence

This discussion on how PVP affects food security and nutrition in developing countries leads one to consider in more general terms the applicability of such an IPR to these countries. Unfortunately, few comparative empirical studies exist, but one such was conducted by UPOV (2005a). It covered five countries experiencing highly varied levels of development (Argentina, China, Kenya, Poland and South Korea) and argued that PVP brought economic benefits.

Two other studies were published in 1994 by the Inter-American Institute for Cooperation in Agriculture and the University of Amsterdam (Jaffé and van Wijk, 1995), and in 2005 for the World Bank by various researchers (Louwaars et al, 2005).

Taking the 1994 study first, the research aimed to examine the expected impact of PVP on developing countries in the areas of 'private investment in plant breeding, breeding policies of public institutes, transfer of foreign germplasm and diffusion of seed among farmers'.

Five countries were used as case studies, of which three (Argentina, Chile and Uruguay) had PVP systems already in place and two (Colombia and Mexico) were about to introduce them. These countries are similar in the sense that each has basically two seed markets. The hybrid seed market is controlled by transnational corporations, whereas the seed market for self-pollinating varieties is dominated by domestic firms.

However, Argentina differs from the others in that it is the only country in which owners of PVP rights have successfully enforced their rights to the extent that their control over seed supply for wheat and soya is comparable to that of their counterparts in the US. This leads the authors of the study report to conclude that, in all probability, PVP in that country has 'prevented the local wheat companies from reducing or even terminating their breeding activities and triggered the reactivation of some soya bean breeding programmes'.

For exotic genetic resources, there is little evidence to show that PVP has led to any significantly improved access for domestic seed companies to modern cultivars, special genetic stocks and genomic material from abroad. Moreover, companies with licences from overseas breeders to use proprietary varieties may sometimes have to contend with restrictions on where they can export to. For example, in 1994 Argentinean strawberry plant growers were prevented from exporting their plantlets to Europe because the US breeder and the European licensees did not want these plantlets to compete with those that were already produced in Europe.

In Argentina and Chile, public agricultural research centres are using PVP to secure income and collaborate with companies. According to the report, this is shifting the orientation of public research and reduces the public availability of their genetic resources.

How are farmers affected? First, Argentinean seed dealers must now pay royalties and taxes on the seed they trade. So far these costs have not been passed on to the farmers. Second, PVP legislation in the three countries where it is well established has not prevented the replanting of farm-saved seed. Third, as the report indicates, 'since many modern plant varieties are not appropriate for resource-poor farmers, PBRs predominantly favour plant breeding for those farmers who operate under relatively prosperous conditions'.

The study for the World Bank covered China, Colombia, India, Kenya and one country that still does not have a PVP regime, Uganda. Among the study's numerous findings is that the availability of PVP is not an absolute prerequisite for the existence of a thriving plant breeding sector. India had quite a large number of private plant breeding firms many years before PVP legislation was passed. Rather cautiously, among the report authors' findings are that 'the ease of implementing PVP seems to be overestimated. In all cases, the effectiveness of PVP is still being tested and refined, and the cases illustrate that establishing a PVP law and putting it into practice are two separate challenges.'

Moreover, as the authors conclude:

not only do IPRs in plant breeding have to be seen in the context of a wider range of agricultural policies, but IPR regimes themselves must be carefully tailored to specific situations. It is important that countries recognize that they have choices in designing legislation consistent with the TRIPS Agreement and that there are still opportunities for debating and interpreting the Agreement itself. The UPOV Conventions offer some important advantages for fulfilling the requirements for a sui generis system but they do not exhaust the possibilities.

Emerging Issues – Harmonization

The big emerging issue is harmonization. UPOV and the associations representing the plant breeders are very keen to see a situation in which PVP is not only available throughout the world but follows the same standards of protection. At present, many countries are still parties to the 1978 version of UPOV, and some countries (for example India) have laws that diverge from any version of UPOV. In the longer term, the associations would probably like to see more regional regimes, such as that in Europe, which has a Community Plant Variety Rights Office. The office, which was established under Council Regulation (EC) No 2100/94 of 27 July 1994, provides a single unitary right covering the whole EU. A certain amount of administrative harmonization may be a good thing for developing countries in terms of cutting the cost of managing the PVP system. But holding an incredibly diverse range of countries to the same substantive rules is inadvisable for similar reasons that harmonized patent rules tend to benefit countries that are 'leaders' and may well hold back the 'followers' (Dutfield and Suthersanen, 2005). Each country should be free to tailor IP systems to their economic conditions and in ways that promote their wider development objectives and strategies.

National Instruments

Realistic proposals for non-UPOV PVP systems have been few and far between. Most countries that do not want to join UPOV use legislation that is based on the 1978 version of the Convention. This is probably one reason why more developing countries are joining UPOV. Nonetheless, it is important to consider alternatives to UPOV so that informed decisions can be made.

To help countries devise an appropriate sui generis system, the International Plant Genetic Resources Institute (IPGRI – now called Bioversity International) came up with a list of key questions that decision makers should take into account:

• What kind of domestic seed industry exists?

• What kind of public breeding sector exists?

• What kind of seed supply system is in place?

• To what extent is farm-saved seed used in the country?

• What is the current capacity of breeders?

• What do local breeders want to do in the next 5–10 years?

• Are external inputs to agriculture low or high?

• What are the country's production needs and objectives?

• What is the country's biotechnology capacity?

• What are the goals and realistic expectations of the biotechnology sector?

• What kinds of strategic alliances will the country want to enter into in the next 5–10 years and how involved will other countries be?

The answers to these questions will vary widely from one country to another, which suggests

that, as with patents, one size is unlikely to fit all. A detailed discussion on all the issues involved falls outside the scope of this chapter, but it is important at least to discuss the requirements for protection and the scope of the systems.

The sui generis clause in TRIPS (see Chapter 3) does give governments a certain amount of freedom to tailor their PVP systems to address such concerns. Thus, while an increasing number of developing countries are joining UPOV, some countries are devising alternative PVP systems that aim in part to strengthen food security. They do this, for example, by allowing farmers to acquire protected seed from any source and/or requiring protected varieties to display qualities that are genuinely superior to existing varieties.

The Indian parliament has passed legislation that would maintain farmers' freedom to save, sell and exchange all produce of a protected variety (Box 2.1), and the African Union (formerly the Organization of African Unity) has developed a model law, for the consideration of member governments, known as the African Model Legislation for the Protection of the Rights of Local Communities, Farmers and Breeders, and for the Regulation of Access to Biological Resources. In both cases, as much emphasis is placed on the interests of farmers as on those of breeders.

The Indian Act appears to reflect a genuine attempt to implement TRIPS in a way that supports the specific socioeconomic interests of all the various producer groups in India, from private sector seed companies to public corporations and research institutions and resource-poor farmers. However, India is in the process of joining UPOV under its 1978 Act, and the 2001 legislation may need to be modified. The Indian case also shows the interaction between PVP and seed legislation, since a new seed bill seems to restrict the same farmers' right to sell seed by requiring compulsory certification.

Conclusion

It is actually very difficult for developing countries to design and implement their own systems of PVP if, as is likely, these would diverge at all from the latest version of the UPOV Convention. Intellectual property reform has always been political as much as technical, never more so than in the present day. As this book and others amply demonstrate, both the EU and the US impose various forms of 'soft' and 'hard' pressure on developing countries to introduce IP rules that they approve of. And for PVP, UPOV provides the approved standards, with no alternatives acceptable to those standards. While India may be strong enough to resist pressure from the EU, US and UPOV, it seems most other countries are too small and weak to have much room for manoeuvre.

The importance of PVP globally, and pressures to introduce the UPOV model into developing countries, stems from the extension of IP requirements into agriculture through the TRIPS Agreement in the WTO, which is the subject of the next chapter.

Resources

Apart from UPOV, other key organizations of importance in this area are the International Community of Breeders of Asexually Reproduced Ornamental and Fruit Tree Varieties (CIOPORA), GRAIN, and the International Seed Federation (ISF) (see Appendix 1).

3
Bringing Minimum Global Intellectual Property Standards into Agriculture: The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS)

Pedro Roffe

The biggest shift in the intellectual property (IP) regime occurred at the end of the 20th century with the introduction of IP into the international trade regime. This de facto made IP rules global and extended the reach of IP into new countries and sectors, notably agriculture. This chapter charts that history and examines the key elements of the new regime under TRIPS, which introduced the requirement for WTO Members to have plant variety protection and extend patentability to micro-organisms. It also looks at the links between TRIPS rules, genetic resources, traditional knowledge and food security.

Background and History

From a formal legal point of view, IP was until recently unrelated to the trading system. Its formal incorporation in the Uruguay Round trade negotiations in 1986 was a controversial North–South issue and also a major novelty.1 It also coincided with the bringing of agriculture and plant and animal health (sanitary and phytosanitary regulations) into the trade regime. All of these became incorporated into the World Trade Organization (WTO), formally established as an outcome of the Uruguay Round.

The relationship between IP protection and international trade was also controversial at the birth of the modern international IP system. When the first attempt to negotiate an international understanding on the protection of patents was made in the last quarter of the 19th century it found Europe in the middle of a major controversy between patent advocates and free traders. The free traders argued that the recognition of patents in different national jurisdictions constituted trade barriers. The compromise made in those days was around the recognition that each member country of the 1883 Paris Convention for the Protection of Industrial Property (patents, trademarks, utility models, industrial designs and unfair competi­tion) would have the freedom to subject the recognition of patents to the local exploitation of the invention. In other words, countries could decide that if you did not produce what was patented in the country where the patent was sought, then the patent could be revoked or be subject to use by third parties via a compulsory licence. It was then understood that trade and patent protection were not necessarily related.

The international governance of IP was further reinforced in the late 19th century with the adoption of another major instrument, the Berne Convention (1886) dealing with copyright. Unlike the Paris Convention, the US was not an active advocate for the Berne Convention, which responded more to the European continental tradition on the treatment of authors and the respect for their moral rights. It was not until 1989, during the Uruguay Trade Round negotiations, that the US joined the Berne Convention.

The international IP architecture grew in the 20th century to specific areas of IP, mainly in copyright and related rights, patents, trademarks, industrial designs and geographical indications, and agreements on the facilitation of IP protection in third countries, like the Patent Cooperation Treaty and the Madrid System for trademarks (see Chapter 4).

A major dislocation to the system occurred in the 1970s, when a number of developing countries, including newly independent countries in Africa and Asia, questioned the international system and its relevance in developing countries for the dissemination of knowledge, access to advanced technologies and control of abuses of intellectual property by right holders. The Berne Convention was amended to respond to some of those concerns by establishing methods for preferential arrangements in the translation of works. A group of developing countries initiated a revision process for the Paris Convention, to respond to their concerns, in the World Intellectual Property Organization (WIPO – see Chapter 4). However, the various diplomatic conferences convened for that purpose failed to achieve the objectives of the revision as proclaimed in the Declaration of Objectives of 1979.

Around that time, major changes were taking place in the US. In the mid-1970s, and more clearly during the Reagan Administration, a link was made in its Trade Act between international trade and the protection of the interests of US firms in their IP dealings in third countries. Countries that did not adequately protect intellectual property rights (IPRs) from US titleholders could be candidates for commercial sanctions. The US system of protection was later reinforced in 1982 by the creation of the US Court of Appeals for the Federal Circuit, which was supposed to bring coherence and consistency in cases dealing with IPRs.

The shortcomings of WIPO in dealing with the enforcement of IPRs and the paralysis produced in the attempt by developing countries to revise the Paris Convention, together with the active organizing by industrial groups for global IP rules, mainly related to the pharmaceutical-chemical, entertainment and software sectors, in the US, Europe and Japan offered the opportunity for the major industrialized powers to claim that the IP system should be fully integrated in the new multilateral trading system that was taking shape in the second half of the 1980s.

Another important antecedent to including IP within the WTO and in general in the pressures for patent reform was the Draft Treaty Supplementing the Paris Convention as far as Patents are Concerned. In 1983, the Director General of WIPO launched a negotiating process for a patent law treaty within an expert committee, a process that continued from 1984 to 1991. The committee gradually expanded the limited initial scope of the treaty to cover other areas of patent harmonization. This process culminated in a diplomatic conference held in The Hague by the end of 1991. It did not succeed, mainly because of the opposi­tion of developing countries that were still sustaining their own initiative for revision of the Paris Convention. However, many of the issues opposed by developing countries in The Hague Diplomatic Conference were finally accepted in the Uruguay Round negotiations on TRIPS. This became possible because the Uruguay Round, although dealing with many different areas, was conducted on the basis that the final deal would be a single undertaking – which meant that countries had to accept all elements of the packets agreed (such as agriculture, services and textiles), even if they really only wanted some of them.

Developing countries initially resisted the initiative of including IP matters in trade negotiations, claiming that WIPO was the specialized agency of the UN and solely responsible for IP matters. The concept of the single undertaking of the Uruguay Round prevailed, however, and this meant developing countries had to agree to everything in the negotiating package. And so, finally, IP matters were fully incorporated in the newly established WTO. The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) was part of the Marrakesh Final Act of 1994. TRIPS, with different modalities of application, entered into force on 1 January 1995.

The TRIPS Agreement

The negotiations towards an accord on IPRs, in the context of the Uruguay Round, were led by a core group of developed countries. This group had a dominant role not only during the negotiations of the TRIPS Agreement and in the preparatory process which concluded with the Punta del Este Ministerial Declaration adopted in December 1986, launching the process of negotiations, but also in the midterm review initiated at Montreal two years later. From the outset, among that core group, the US clearly advocated a strong position on including IP issues in the GATT system. In fact, during the previous trade round (the Tokyo Round), the US had floated a proposal for an Anti-Counterfeiting Code, although it was not actively pursued. From the US perspective the improvement of IP should be a GATT objective because inadequate protection of IPRs in a number of countries posed serious and growing trade-related problems. The US views of the scope of the upcoming IP negotiations – not completely shared at the beginning by all developed countries, particularly those of the EC, which at that time did not have a community position on this matter – were ambitious, going beyond the mere establishment of rules on anti-counterfeiting goods. The US position essentially represented the interests of a number of large corporations from a few sectors, some of whose lobbyists helped draft the initial proposals (Sell, 2003). These lobbies also mobilized industry groups in the EU and Japan to support the TRIPS proposals.

This expansive approach to IP was very much opposed by developing countries, led by Brazil and India. They believed that the protection of IPRs was a non-GATT issue and that consequently it was outside the realm of trade negotiations and therefore had no place in the deliberations of the Preparatory Committee of the Ministerial Conference. This view was reflected in the proposal submitted for the Ministerial Declaration to be adopted at Punta del Este and forwarded to the Committee by Brazil jointly with nine other developing countries (Argentina, Cuba, Egypt, India, Nicaragua, Nigeria, Peru, Tanzania and Yugoslavia),2 where no reference to intellectual property matters was included.

From the outset of the Uruguay Round negotiations in 1986, and until early 1989, developing countries were opposed to incorporating substantive standards of IPR protection

in GATT. However, based on the Punta del Este Declaration, there was acceptance of basic protection against trademark counterfeiting and copyright piracy. The initial resistance of developing countries to broader IPR standards was overcome through a combination of concessions offered by developed countries in areas such as agriculture and textiles and by threats of trade sanctions (Box 3.1).

Main elements

The TRIPS Agreement was incorporated as Annex 1C of the Marrakesh Agreement Establishing the World Trade Organization (WTO), which was concluded on 15 April 1994, more than three years later than originally planned. TRIPS has 73 provisions organized in seven parts:

1 general provisions and basic principles;

2 standards concerning the availability, scope and use of IPRs;

3 enforcement;

4 acquisition and maintenance of rights and related inter partes procedures;

5 dispute prevention and settlement;

6 transitional arrangements; and

7 institutional arrangements and final provisions.

The TRIPS Agreement is particularly relevant in the history of IP because it breaks with the tradition of the classical conventions of the 19th century. No longer is the harmonization of standards a bottom–up approach, but it is now based on the principle of minimum standards of protection. Before TRIPS, countries could exclude some industrial or technological sectors from patentability (as the Paris Convention does not contain any obligation in this respect) and also discriminate against the patentability of process and products. The pharmaceutical and food and beverages sectors were among the most excluded among countries regarding the patentability of both products and/or processes. The German industrial property law of 1877 was the first to exclude food products from patentability, to avoid price increases associated with monopolistic protection, particularly in a country which, at that time, was suffering from food shortages. By the mid-1950s, at least Austria, Bulgaria, Canada, Chile, Colombia, Czechoslovakia, Denmark, Ecuador, Estonia, Iceland, Japan, Luxemburg, Norway, Sweden, Switzerland and Yugoslavia had the same exclusion.

The minimum standards of protection in disciplines such as copyright and related rights, trademarks, geographical indications, industrial designs, patents, layout designs of integrated circuits, protection of undisclosed information and control of anti-competitive practices in contractual licences, listed in Part II of the Agreement, are supplemented by those of the Paris and Berne Conventions, which are explicitly imported into TRIPS (with the exception of the moral rights of authors under the Berne Conventions). In addition, TRIPS also breaks with the tradition that IP matters were dealt with primarily by WIPO, which already administered the most important international treaties on different IP-related issues in force at that time (see Chapter 4).

The main features of the Agreement, compared to earlier instruments on IP, are:

• Its comprehensive coverage. One single instrument covers the major IP disciplines through the establishment of minimum standards in each of them.

• The inclusion, for the first time, of disciplines related to the enforcement of IP rights. WTO Members should not only recognize and protect those rights but set up mechanisms that would guarantee, through administrative procedures and civil and criminal procedures, including border measures, the appropriate means for the domestic enforcement of those rights.

• The full incorporation of IP into the international GATT-style trading system. This means that the main pillars of the system – national treatment and most favoured nation (MFN) treatment, among others (see definitions below) – should apply in the relationships among Members. Of these two core principles, MFN is an absolute novelty to IP international treaties. The second major consequence of this formal incorporation of IP in the trading system is the application of the WTO principles for effective and expeditious procedures for the multilateral prevention and settlement of disputes between governments. The application of these procedures could justify measures of commercial retaliation, including cross-retaliation (a retaliation adopted by the complaining party in another sector from that in which the infraction was made: goods, services or IPRs), in the event of non-compliance by Members of their obligations under TRIPS. The cross-sectoral, sanctions-backed dispute settlement mechanism (DSM) in the WTO is quite different from that under GATT. This DSM could be extended to violations of the Agreement or to cases described in the WTO system as non-violation complaint situations. Non-violation complaints were conceived in the GATT system to protect parties against nullification or impairment of their trade in goods expectations by possible actions by a Party that, without contravening a particular trade obligation, might nonetheless impair another Party's trade expectations or benefits (Box 3.2).

General provisions and basic principles

The first part of TRIPS outlines the general provisions, its basic principles and objectives, namely:

• The minimum standard of protection. The Agreement specifies that Members are not obliged to implement in their laws more extensive protection than is required in the Agreement, provided that such protection does not contravene the provisions of the Agreement. This means that Members could provide more extensive protection if they so wish. This is happening in the new generation of free trade agreements with special chapters on IP, characterized as TRIPS-plus agreements (see Chapter 7). The provisions of the TRIPS Agreement, however, are not always drafted in a mandatory way. The Agreement leaves space for some flexibility in the implementation of its provisions as was reiterated in the Doha Ministerial Declaration on TRIPS and public health (see below and also Chapter 9). Part II of TRIPS gives details of the minimum standards provided for the different disciplines covered by the Agreement. The Agreement, within this flexibility, provides for the freedom of implementation of its provisions, in the sense that Members are free to determine the appropriate method of translating the Agreement within their own legal system and practice.

• The national treatment principle incorporated in the classical WIPO-administered conventions sanctions the non-discrimination between nationals and foreigners. Thus foreign IP right holders should receive in other Members a treatment similar to that accorded to own nationals. But, compared to the classical conventions and influenced by a US–Korea IP-related agreement in the late 1980s, the national treatment principle in TRIPS is expressed as 'treatment no less favourable' than that accorded to own nationals.

• The most favoured nation (MFN) treatment is a major novelty compared with the classical IP conventions. The MFN requires non-discrimination among foreigners. Through this principle, which accepts very limited exceptions, countries cannot be treated differently over the protection of IP. The principle means that any advantage, favour, privilege or immunity granted by a WTO Member to a national of any other country (for example in a bilateral agreement) – whether a WTO Member or not – is immediately and unconditionally extended to the nationals of all other WTO Members.

• Finally, Part I of the Agreement spells out the guiding objectives and principles underpinning the protection and enforcement of IPRs. Article 7 states that 'intellectual property rights should contribute to the promotion of technological innovation and to the transfer and dissemination of technology, to the mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare, and to a balance of rights and obligations'. While Article 8.1 provides that 'Members may, in formulating or amending their laws and regulations, adopt measures necessary to protect public health and nutrition, and to promote the public interest in sectors of vital importance to their socioeconomic and technological development, provided that such measures are consistent with the provisions of this Agreement'.

Substantive minimum standards

The fundamental principle in TRIPS of minimum standards differentiates this Agreement from the classical IP conventions. All WTO Members, without differentiation, are obliged to implement and observe these minimum standards in their national legislation. The Agreement recognizes, however, some differentiation among groups of Members in the degree and timing of this implementation, an idea that was first formally introduced in a proposal by Switzerland to the TRIPS Negotiating Group in May 1990.3 Transitional periods were recognized in several proposals and in the final text given to developing countries and countries with economies in transition. These transitional periods expired for all these countries on 1 January 2005. However, for the least developed countries, subsequent decisions of the WTO Council for TRIPS have waived the obligation of implementation until June 2013 and for pharmaceutical products until 1 January 2016.

The substantive standards are spelt out in Part II of TRIPS for all the categories of IP covered by the Agreement. Probably the most far-reaching changes brought about by TRIPS, particularly compared with the situation prevailing before the Agreement, concern patents (UNCTAD, 1997, p30) and undisclosed information, this latter area being included for the first time in a multilateral IP-related agreement. In all the other areas covered by the Agreement, TRIPS in many respects imported and expanded the main standards covered already in pre-existing WIPO-administered treaties. However, it gives to these imported standards the benefit of the enforcement provisions and the dispute settlement mechanism provided under TRIPS.

Key patent rules

For patents, the Agreement includes a number of important features; these are described in the following sections.

Scope and duration

In a major departure from the Paris Convention, TRIPS provides that patents shall be available for products and process, and patents rights enjoyable without discrimination as to the place of inven-

tion, the field of technology and whether products are imported or locally produced. This major feature of the Agreement was not free of controversy (Box 3.3), nor is there agreement on the obligations it imposes. Some argue that this means that countries are no longer free to grant patent protection in some sectors while excluding others – which was normal for pharmaceuticals, chemicals and food products before TRIPS. For example, at the time of the negotiations of the Uruguay Round almost half of the known patent laws excluded pharmaceutical products from protection. In some cases – in Brazil, for example – exclusion from patentability included the entire sector. One third of those laws excluded inventions on food products. Others assert that this TRIPS provision does not require patents for all sectors. For example, even though business methods and software are not specifically excepted from this provision, at the time the TRIPS Agreement was negotiated even proponents of this provision did not believe that patents should generally be issued for them.4 In addition, the WTO in one of its dispute panels held that 'discrimination' under this provision means unjustified differentiation, and thus differential treatment may be normatively justified.5

The principle of non-discrimination not only means that patents are available for any inventions, whether products or processes, in all fields of technology, but also that the granting period was standardized to no less than 20 years (see below). Note too the intrusive nature of the Agreement compared to the prevailing situation before TRIPS. The bottom–up approach to harmonization that characterized the international regimes under the classical conventions left each country with the freedom to determine the patentability criteria to be applied and the term of the patent protection. The TRIPS Agreement, however, reflects the broad parameters of patentability applied in major developed countries, namely that patents are available for inventions, whether products or processes, provided that they are new, involve an inventive step and are capable of industrial application.

Exclusions

Before TRIPS, countries could exclude from patentability any inventions, but according to the new minimum standard of non-discrimination under TRIPS, Members may only exclude from patentability certain inventions, 'necessary to protect ordre public or morality, including to protect human, animal or plant life or health or to avoid serious prejudice to the environment, provided that such exclusion is not made merely because the exploitation is prohibited by their law' (Article 27.2).

One of the most controversial provisions of the Agreement, and of great importance for agriculture, biodiversity and the future of food, concerns whether or not living organisms are patentable. Article 27.3(b) states:

Members may also exclude from patentability: plants and animals other than micro-organisms, and essentially biological processes for the production of plants or animals other than non-biological and microbiological processes. However, Members shall provide for the protection of plant varieties either by patents or by an effective sui generis system or by any combination thereof.

It also says its provisions will be reviewed four years after entry into force of the Agreement.

Rights of patent holders

In another major departure from the prevailing system before TRIPS, the Agreement provides an exhaustive definition of the exclusive rights conferred by a patent on its owner. These include the right 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 the product, in the case of a product patent, or the product obtained directly by that process, in the case where the subject matter of a patent is a process. Also important in TRIPS is the definition of the term of protection that shall not end before the expiration of a period of 20 years counted from the filing date. The practice prior to TRIPS varied between countries, with some recognizing the 20 years and others discriminating according to sectors. In India, for example, the general rule was a patent duration of 14 years, while for pharmaceutical and food products the duration was only 7 years.

As explained, patents confer an exclusive right to prevent others from using the invention without the authorization of the patent holder. However, the conferred rights are not absolute. Under most patent laws, such rights may not be exercised with regard to certain acts by third parties. Thus, under certain specified circumstances, there may be exceptions to the exclusive rights. However, the Agreement limits the establishment of exceptions to those exceptions that 'do not unreasonably conflict with a normal exploitation of the patent and do not unreasonably prejudice the legitimate interests of the patent owner, taking account of the legitimate interests of third parties' (Article 30). The purpose of the exceptions, as well as their scope, may vary significantly among national laws, depending on the policy objectives pursued in each country. Such exceptions may apply to non-commercial acts (for example private use or scientific research) or to commercial acts. In some cases, they aim at increasing static efficiency by speeding up competition (for example the early working exception), while in others the main concern is enhancing dynamic efficiency by avoiding barriers to future research (for example experimental exception) (UNCTAD-ICTSD, 2005, p430).

Compulsory licensing

On the granting of compulsory licensing, the Agreement sets up 14 conditions or modalities in cases where the law of a WTO Member allows for other use of the subject matter of a patent without the authorization of the right holder, including use by the government or third parties authorized by the government. These conditions are:

• the need for the proposed user to negotiate beforehand with the right holder on reasonable commercial terms and conditions for a licence to use the invention. This requirement may be waived in the case of a national emergency or other circumstances of extreme urgency or in cases of public non-commercial use;

• the scope and duration of such use shall be limited to the purpose for which it was authorized;

• such use shall be non-exclusive;

• any such use shall be authorized predominantly for the supply of the domestic market of the Member authorizing such use;

• authorization for such use shall be terminated if and when the circumstances which led to it cease to exist and are unlikely to recur;

• the right holder shall be paid adequate remuneration in the circumstances of each case, taking into account the economic value of the authorization; and

• the legal validity of any decision relating to the authorization of such use shall be subject to judicial review or other independent review by a distinct higher authority in that Member.

The Agreement, as confirmed by the Doha Declaration on TRIPS and Public Health of 2001, does not interfere with the right of Members to define the grounds for the granting of compulsory licences.

Burden of proof in process patent infringement cases

The TRIPS Agreement includes a special provision about civil proceedings in process patents where the judicial authorities shall have the authority to order the defendant to prove that the process to obtain an identical product is different from the patented process. Process patents are a weak form of protection because of the difficulties involved in proving infringement. This provision reverses the burden of proof and facilitates proceedings in cases, particularly of pharmaceuticals and food products, that in most cases prior to TRIPS could only be protected as processes and not as products as now allowed by the Agreement. The effect was that for practical purposes pharmaceutical products were not fully protected, because the key feature of a pharmaceutical product is usually its molecule, and in practice the composition of this is fairly easy to analyse, though the same molecule must be manufactured by an alternative method in order not to infringe the process patent. The Agreement attempts to deal with this perceived weakness by reversing the obligation of the holder of the patent process to prove that there is an infringement, so that if the defendant has produced an identical product to that produced by the process patent, the onus shifts to the defendant to show that the product was produced without use of the process covered by the patent (UNCTAD-ICTSD, 2005, p503).

Data protection for pharmaceuticals and agrochemicals

Finally, related to patent protection particularly of pharmaceutical and chemical entities, the Agreement prescribed that Members, 'when requiring, as a condition of approving the marketing of pharmaceutical or of agricultural chemical products which utilize new chemical entities, the submission of undisclosed test or other data, the origination of which involves a considerable effort, shall protect such data against unfair commercial use' (Article 39.3). The scope of this requirement is subject to dispute. The same article continues: 'In addition, Members shall protect such data against disclosure, except where necessary to protect the public or unless steps are taken to ensure that the data are protected against unfair commercial use.'

The powerful pharmaceutical 'research-based industry' considers the protection of data submitted for the registration of medicines to be of considerable economic importance. The reasoning is that the manufacturer has invested, often heavily, in the research necessary to develop the relevant data, and where patent law fails to provide protection (for example because the active component was shortly to be out of patent, or because the drug was based on a combination of known substances used in novel manner), the secrecy of the testing work would provide the only barrier to a competitor rapidly producing and registering an exact copy of the drug. From a public health perspective, however, the early entry of generic competition is also seen as an important policy objective, whose realization is facilitated by regulations that allow health authorities to rely on existing test data to approve subsequent applications for generic products (see UNCTAD-ICTSD, 2005, p538). This important provision of TRIPS did not fully capture a requirement specifically to provide exclusive protection of test data for a number of years, although it was arguably the intention of some of the promoters of the provision.6 The Agreement recognized that undisclosed information should be protected against unfair competition, thus against dishonest industrial or commercial practices. Under traditional treaty interpretation principles, countries may choose how to implement a provision having no clearly specified meaning.7However, recognition of exclusive protection of the data for a number of years (for example for at least five years from the date of approval of the pharmaceutical product) has been achieved in recent free trade agreements signed by European Free Trade Association (EFTA) countries and the US with a number of developing countries (see Chapter 7).

TRIPS and Genetic Resources, Traditional Knowledge and Food Security

As already pointed out, the Agreement deals with all the major IP disciplines, incorporating and expanding the coverage of protection to all areas and industrial sectors. With patents this is made explicit in the Agreement because a number of sectors, including food products, were, prior to the advent of TRIPS, not required to be under patent protection. As also described above, the exceptions to patentability are limited to particular cases and 'exclusion is not made merely because the exploitation is prohibited' by domestic law. Given the far-reaching nature of the changes, their full impact, especially since developing countries only had to become fully compliant in 2005 (least developed countries have until 2013), will take some time to emerge.

Under the principles of the Agreement (Article 8), Members may, in formulating or amending their laws and regulations, adopt measures necessary to protect nutrition, provided that such measures are consistent with the provisions of TRIPS. Article 8 of the Agreement refers to nutrition as well as to health. This provision, in the case of health, was reaffirmed by WTO Members in the Doha Ministerial Declaration on Health and TRIPS in emphatic terms:

We agree that the TRIPS Agreement does not and should not prevent Members from taking measures to protect public health. Accordingly, while reiterating our commitment to the TRIPS Agreement, we affirm that the Agreement can and should be interpreted and implemented in a manner supportive of WTO Members' right to protect public health and, in particular, to promote access to medicines to all. In this connection we reaffirm the right of WTO Members to use, to the full, the provisions in the TRIPS Agreement, which provide flexibility for this purpose.

The reasons provided in the case of health could be extended to nutrition. However, this principle could not be interpreted in a loose way, simply authorizing Members to override patent protection. In both the TRIPS Agreement and the Doha Declaration the language is qualified. Such measures should be consistent with the Agreement. However, a sound interpretation of these provisions should reaffirm the notion that 'discretion to adopt measures is built into the Agreement. Challengers should bear the burden of establishing that discretion has been abused' (UNCTAD-ICTSD, 2005, p127).

Article 27.3(b)

Article 27.3(b) of TRIPS deals with one of the most controversial issues covered by the Agreement. Sometimes called the 'biotechnology clause', it describes inventions that Members may exclude from patentability while, at the same time, specifically obliging them to protect micro-organisms and certain biotechnological processes.

The final drafting of this clause reflected, on the one hand, the strong interests of some developed countries in ensuring protection of biotechnological innovations and, on the other, the differences existing among such countries

Table 3.1 WTO Members' obligations under Article 27.3(b) of TRIPS

over the scope of protection, as well as the concerns expressed by a number of developing countries about the patentability of life forms. The ambiguous terminology of Article 27.3(b) (see also Table 3.1) is not easy to grasp:

Members may also exclude from patentability … plants and animals other than micro-organisms, and essentially biological processes for the production of plants or animals other than non-biological and microbiological processes. However, Members shall provide for the protection of plant varieties either by patents or by an effective sui generis system or by any combination thereof. The provisions of this subparagraph shall be reviewed four years after the date of entry into force of the WTO Agreement.

Many developing countries have reiterated their discomfort with the implications of this provision, particularly on the need to reconcile TRIPS with the relevant provisions of the Convention on Biological Diversity and on prior informed consent and benefit sharing (see Chapter 5). The African Group in the WTO has consistently raised concerns about the implications of this provision of the Agreement on life forms. In their view there should not be a possibility, within the framework of the TRIPS Agreement, of granting patents on micro-organisms as well as on non-biological and microbiological processes for the production of plants and animals (Box 3.4).

TRIPS leaves flexibility for Members to adopt different approaches on the patentability of inventions relating to plants and animals, but unambiguously requires the protection of micro-organisms although, as with other terms in TRIPS, the meaning of micro-organism is not defined, leaving space for flexibility. In addition, this article obliges Members to provide protection for 'plant varieties':

While the Agreement is flexible about the form of protection of plant varieties, it is definite on the introduction of protection in an area in which most developing countries had none before the adoption of the Agreement. This obligation has raised concerns in some of those countries about the impact of IPR protection on farming practices (particularly the reuse and exchange of seed by farmers), genetic diversity and food security. (UNCTAD-ICTSD, 2005, p390)

TRIPS allows for the exclusion from patentability of 'plants and animals' in general. Consequently, Members may exclude plants as such (including transgenic plants), plant varieties (including hybrids), as well as plant cells, seeds and other plant materials. They may also exclude animals (including transgenic) and animal breeds.

On the other hand, the Agreement states that Members 'shall provide for the protection

of plant varieties either by patents or by an effective sui generis system or by any combination thereof.'

The reference to patents is straightforward, due to the detailed treatment of them in TRIPS. The reference to an 'effective sui generis system' is not so obvious. It might suggest the breeders' rights regime, as established in the UPOV Convention, but the text very deliberately did not refer to UPOV. The possibility is open to combine the patent system with a breeders' rights regime, or to develop other 'effective sui generis' forms of protection.

In recent bilateral free trade agreements (FTAs) concluded between on one side the US, EU and EFTA and on the other a number of developing countries, the UPOV Convention has been listed as one of the international IP treaties that the parties should subscribe to in the near future. In these cases protection of plant varieties will follow the breeders' rights model. Moreover, in FTAs where the US is a party, countries undertake further commitments to make efforts to introduce legislation concerning the patenting of plants. For example, although Chile is a member of the 1978 UPOV Convention, the FTA with this country provides for a 'best effort' clause in order for each party to undertake reasonable efforts, through a transparent and participatory process, to develop and propose legislation, within four years from the entry into force of the agreement, to make available patent protection for plants which are new, involve an inventive step and are capable of industrial application. In other FTAs, such as that between the US and Morocco, there is a straightforward obligation for the parties to grant patents to inventions on animals and plants (see Chapter 7).

On this specific issue, the report of the UK Commission on Intellectual Property Rights (IPRs Commission, 2002, p66) concluded that developing countries should explore all the flexibilities provided by TRIPS. It favours different forms of sui generis systems for plant varieties. It recommended that:

Developing countries should generally not provide patent protection for plants and animals, as is allowed under Article 27.3(b) of TRIPS, because of the restrictions patents may place on use of seed by farmers and researchers. Rather they should consider different forms of sui generis systems for plant varieties.

Those developing countries with limited technological capacity should restrict the application of patenting in agricultural biotechnology consistent with TRIPS, and they should adopt a restrictive definition of the term 'micro-organism.'

Countries that have, or wish to develop, biotechnology-related industries may wish to provide certain types of patent protection in this area. If they do so, specific exceptions to the exclusive rights, for plant breeding and research, should be established. The extent to which patent rights extend to the progeny or multiplied product of the patented invention should also be examined and a clear exception provided for farmers to reuse seeds.

The continuing review of Article 27.3(b) of TRIPS should also preserve the right of countries not to grant patents for plants and animals, including genes and genetically modified plants and animals, as well as to develop sui generis regimes for the protection of plant varieties that suit their agricultural systems. Such regimes should permit access to the protected varieties for further research and breeding, and provide at least for the right of farmers to save and plant-back seed, including the possibility of informal sale and exchange.

The WTO review process of Article 27.3(b)

Article 27.3(b) provides for a review process. This built-in review started in the TRIPS Council in December 1998 (Box 3.5). At that time the Council invited Members that were already under the obligation to fully implement the Agreement to provide information on how the obligations under Article 27.3(b) had been addressed in their domestic legislation. Pursuant to the Doha Ministerial Declaration of 2001, two new related issues were incorporated into the agenda of the TRIPS Council, namely the relationship between the TRIPS Agreement and the Convention on Biological Diversity (CBD) and the protection of traditional knowledge and folklore. Further discussions on the same issues have also taken place within the WTO Committee on Trade and Environment and the WTO General Council.

Within the TRIPS Council the review of Article 27.3(b) has focused on three main issues:

1 patents;

2 sui generis protection of plant varieties; and

3 transfer of technology.

Patent issues

A major contentious issue is the case for and against providing patent protection for plant and animal inventions, particularly from a development perspective. Australia, China, Japan, Singapore, Switzerland and the US have put forward arguments in favour. India and Kenya, generally expressing the views of the African Group, have been the main exponents of the case against (Table 3.2). Singapore and the US maintain that exceptions to patentability authorized by these provisions are unnecessary and that patent protection should be extended to all patentable inventions for plants and animals.

The deliberations in the Council for TRIPS about Article 27.3(b) have focused on four different approaches:

1 Exceptions to Article 27.3(b) are unnecessary and patent protection should be extended to all patentable inventions of plants and animals (US, Singapore).

2 Article 27.3(b) should be maintained as it permits countries to exclude plants and animals from patentability (Australia, Canada, China, Korea, the EC, Japan, Switzerland, Brazil).

3 Exceptions to Article 27.3(b) must be retained but subject to clarification or definition of certain terms, including the

Table 3.2 Main arguments in the TRIPS Council for and against patent protection for plants and animals

difference between plants, animals and micro-organisms (Brazil, India, Peru, Thailand, Zimbabwe).

4 Article 27.3(b) should be amended or clarified to prohibit the patenting of all life forms (Bangladesh, India, African Group (see Box 3.4)).

In order to finalize the review of Article 27.3(b) it has been proposed that some areas of possible agreement need to be identified, including:

• freedom to adopt appropriate regimes to protect plant varieties;

• TRIPS and the CBD should be implemented in a mutually supportive manner;

• TRIPS does not prevent the protection of traditional knowledge; and

• recognition of the importance of genetic resources and traditional knowledge documentation to help patent examination.

Where it seems that a common understanding does not exist is in relation to:

• eliminating the patentability of life forms;

• the need to clarify certain terms of Article 27.3(b);

• the protection of traditional knowledge; and

• the way TRIPS and the CBD should be mutually supportive.

Other issues raised during the review of Article 27.3(b) concern the:

• scope of exceptions to patentability in Article 27.3(b);

• ethical exceptions to patentability under this provision; and

• conditions of patentability for plant and animal inventions.

In fact, discoveries of naturally occurring organisms, and isolated and purified naturally occurring materials (including genetic resources), have a long history of exclusions based on religious grounds, and ethical concerns remain about such patents and patents on non-technological inventions.

At the time of writing, the deliberations in the Council for TRIPS continue with no major changes in the positions adopted by Member countries.

Sui generis protection

Various arguments in favour of and against the sui generis protection of plant and animal varieties have been raised during the discussions. Some suggest that a reference to the UPOV Convention could be included under Article 27.3(b) while others suggest that the minimum protection provided should be by any 'effective' sui generis system. Other issues include the relationship between the TRIPS requirement to have an effective sui generis protection system and the UPOV Convention and the relationship between the sui generis protection of plant varieties and traditional knowledge and farmers' rights.

Transfer of technology

The TRIPS Council has also focused on the implications of patent protection for life forms and sui generis plant varieties protection for access to and transfer of technology. This latter point is seen as one of the basic objectives of the protection of IPRs in TRIPS:

The protection and enforcement of intellectual property rights should contribute to the promotion of technological innovation and to the transfer and dissemination of technology, to the mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare, and to a balance of rights and obligations. (Article 7)

The relationship between TRIPS and the CBD

The built-in review of Article 27.3(b) of TRIPS clearly has not yet generated consensus and is one of the outstanding negotiating issues of the Doha Round, which includes 'the relationship between the TRIPS Agreement and the Convention on Biological Diversity (CBD), the protection of traditional knowledge and folklore'.

The CBD requires each Contracting Party to implement several measures in order to ensure the in-situ and ex-situ conservation of genetic resources. It recognizes the authority of national governments to determine access to genetic resources, subject to national legislation. Under the CBD, access, where granted, shall be on mutually agreed terms and subject to prior informed consent of the Contracting Party providing genetic resources and on the basis of benefit sharing. (The CBD is discussed in detail in Chapter 5.)

The relationship between the provisions of TRIPS and the CBD has given rise to different opinions as to their compatibility or inconsistency. The latter have been associated with the possible granting of IPRs, based on or consisting of genetic resources, without observing the prior informed consent and benefit sharing obligations established by the CBD. Since the adoption of the WTO Doha Ministerial Declaration the issue has been included in the agenda of the TRIPS Council and is the subject of parallel 'dedicated consultations' under the responsibility of the Director General of the WTO.

Different views on the TRIPS–CBD relationship have been expressed at the WTO in relation to the review of Article 27.3(b). While a number of developed countries have found no inconsistencies between the two treaties, several developing countries have indicated the need to reconcile them, possibly by means of a revision of TRIPS.

The main concern of developing countries is that TRIPS does not require patent applicants whose inventions incorporate or use genetic material or associated knowledge to comply with the obligations of the CBD. As pointed out, the CBD makes access to genetic material subject to prior informed consent of and equitable benefit sharing with the Contracting Party providing the genetic resources. Developing countries have repeatedly voiced concern about possible misappropriation of their genetic resources by developed country patent applicants.

During the negotiations of the WIPO Patent Law Treaty this issue was raised by Colombia and supported by a number of developing countries. It was not finally included in the Treaty largely because developed countries argued that this would imply adding a new basic requirement to patentability, in addition to novelty, inventive step and industrial applicability. It has been suggested that an unintended outcome of the Colombian proposal has been the establishment of WIPO's Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore (IGC) (see Chapter 4).

To address these concerns, developing countries have proposed in the WTO8 to amend TRIPS so as to require an applicant for a patent relating to biological materials or traditional knowledge to provide, as a condition for obtaining the patent:

• disclosure of the source and country of origin of the biological resource and of the traditional knowledge used in the invention (see Chapter 7);

• evidence of prior informed consent through approval by authorities under the relevant national regime; and

• evidence of fair and equitable benefit sharing under the relevant national regime.

The approach to enforce CBD obligations through the TRIPS patent system is gaining support among developing countries but is opposed by a number of developed countries that see no conflict between the TRIPS Agreement and the CBD. For example, in the view of the US, the proposed disclosure requirement is not an appropriate solution; rather Members should focus on remedies such as the use of organized databases, information material to patentability, and the use of post-grant opposition or re-examination systems as an alternative to litigation.9 Norway, on the other hand, supports an amendment to the Agreement by introducing a mandatory obligation to disclose the origin of genetic resources and traditional knowledge in patent applications. In the view of Norway, this amendment should provide that patent applications should not be processed unless the required information has been submitted. However, conversely to the approach of developing countries, non-compliance with the disclosure obligation discovered post-grant should not affect the validity of the patent.10 The US and most developed countries support efforts in WIPO to ensure that prior art related to traditional knowledge is better integrated into the international patent system (see Chapter 4).

The protection of traditional knowledge (TK) and folklore

Discussions in the WTO have mainly focused on the questions of the right forum or fora for TK protection and the real need for international action on this matter. Developing countries support the creation of international rules and TK protection being principally negotiated in the WTO. In these countries' view, any other forum, including WIPO, would not provide the appropriate means for the enforcement of rights. The argument being used here is the same that developed countries used when deciding to introduce IP issues in the multilateral system in view of the lack of effective enforcement obligations in WIPO.

Developed Members are not yet convinced that the issue is ripe for international action and mainly oppose treating TK in the WTO and insist that the matter should be dealt with under WIPO auspices (in the Intergovernmental Committee on Genetic Resources, Traditional Knowledge and Folklore – IGCGRTKF or, more commonly, IGC). Some of the arguments relate to the expertise of WIPO as well as to the need to explore further the many complexities of the issue.

Table 3.3 summarizes the main arguments advocated in favour of or against the protection of TK in the Council for TRIPS. Other issues that have been discussed in the TRIPS Council on the protection of TK include the granting of patents to TK and prior and informed consent and benefit sharing.

National implementation of the TRIPS obligations

Considerable differences exist in national laws about the patentability of biotechnological inventions and life forms. For most developing countries, Article 27.3(b) called for a substantial change in national law, since the majority did not protect plant varieties and life forms such as micro-organisms at the time of negotiation and adoption of the Agreement.

Bilateral free trade agreements signed in recent years, as outlined earlier, have adopted certain models for the implementation of Article 27.3(b), including the subscription to and ratification of UPOV and the protection of life forms via patents (see Chapter 7).

Table 3.3 Arguments in the TRIPS Council for or against international rules on the protection of TK

Thus many developing countries have joined or are in the process of joining UPOV. Other countries have explored the development of non-UPOV modes of protection such as the Indian Plant Variety Protection and Farmers' Rights Act passed in 2001 (Chapter 2, Box 2.1).

Peru has established a legal system for the protection of TK associated with biodiversity, including the setting up of a National Anti-Biopiracy Commission. The law reflects the CBD requirements of prior informed consent and benefit sharing. It enables indigenous and local communities to assert their rights over collectively held knowledge. For this purpose, the law obliges interested parties to obtain the prior informed consent of those communities providing the biodiversity-related knowledge.

Conclusion

TRIPS impinges on many other areas of activity, not least food and agriculture. It also deals with issues under negotiation and covered by agreements in other places, the interactions between which are discussed further in Chapter 7. The next chapter discusses the UN body devoted solely to IP, which was initially eclipsed by TRIPS.

Resources

Four organizations with a wealth of web-based resources to tap are the International Centre for Trade and Sustainable Development (ICTSD), The United Nations Conference on Trade and Development (UNCTAD), WIPO and WTO.

A great resource is also found on both the ICTSD website and www.iprsonline.org, where all the papers on IP and development from the UNCTAD-ICTSD TRIPS and Development Capacity Building Project and the full content of the Resource Book on TRIPS and Development are available.

4
Promoting and Extending the Reach of Intellectual Property: The World Intellectual Property Organization (WIPO)

Maria Julia Oliva

The TRIPS Agreement was the first international instrument to introduce minimum standards for intellectual property (IP) protection at the global level, but – even before the WTO was established – WIPO agreements and activities were critical in shaping IP protection. WIPO is even more significant now, with ongoing discussions and negotiations representing the tension between efforts to increase levels of international IP protection and efforts to balance IP protection with other public policy objectives. In addition, WIPO has a key role in the dynamic of the shifting and cross-cutting negotiation of IP issues in a variety of fora. Not only is WIPO closely linked to the implementation of the TRIPS Agreement, for example, but WIPO treaties are also increasingly included in a number of bilateral trade agreements. This chapter examines the origins and activities of WIPO and how its work relates to the concerns about IP and biodiversity, food and other aspects of sustainable development, including traditional knowledge.

Introduction

Its first predecessor, the Bureaux Internationaux Réunis pour la Protection de la Propriété Intellectuelle (BIRPI – the United International Bureaux for the Protection of Intellectual Property), was created in 1893 to administer the Berne and Paris Conventions, but the World Intellectual Property Organization (WIPO) has been – until recently – little known and understood outside intellectual property (IP) offices. Its broad range of norm setting, administrative and technical assistance activities, however, fundamentally affect IP rules at both the international and national levels. As a result, and given a growing acknowledgement of the links between IP and sustainable development, awareness of the relevance of WIPO is increasing.

As the international IP regime expands to

include a diversity of multilateral agreements, international organizations, regional conventions and bilateral arrangements, WIPO remains one of its cornerstones. Indeed, the strategic importance of WIPO has only increased. For a certain time, as was discussed in Chapter 3, industrialized countries seeking higher levels of IP protection favoured putting IP discussions into the multilateral trade system to achieve minimum standards enforceable through its dispute settlement system. Nevertheless, WIPO has recently regained its role as the leading organization in multilateral IP norm setting, with several treaties currently being considered under its auspices. WIPO agreements, moreover, are often incorporated in other norms, as happened with the incorporation of the Paris and Berne Conventions into the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement). It is now more and more common for them to be included in regional and bilateral trade agreements. Some of these commit signatories to sign up to future agreements to be concluded at WIPO (see Chapter 7).

In addition, WIPO is highly influential, given the extensive technical assistance it provides or facilitates. The scope of such technical assistance is not limited to WIPO agreements, but extends to all IP concerns and implementation on which WIPO Member States may request support. In addition, on the basis of an agreement between WIPO and the WTO, WIPO provides legal and technical assistance to implement the TRIPS Agreement. Finally, as WIPO is the UN specialized agency on IP-related issues, it also collaborates with other UN agencies, which generally seek its guidance on these issues. The relationship, often controversial, between WIPO and other international organizations, particularly in relation to biodiversity and food security issues, will be discussed in Chapter 7.

Through all these activities, WIPO has a profound impact on IP rules at both the international and national levels and thus on how these rules affect the conservation and sustainable use of biodiversity, the promotion of food security and other international sustainable development objectives. Nevertheless, these links have only recently begun to be considered in WIPO, an organization that has traditionally regarded its objective to be to increase levels of IP protection around the world. Current efforts to promote a more balanced approach to WIPO objectives, strategies and activities – including on biodiversity and food security issues – have necessarily had to address not only specific topics and discussions, but the organizational structure, culture and dynamics that limited WIPO's consideration of the links between IP and sustainable development. As discussions mount on WIPO reform, biodiversity concerns are at the forefront of some of the central demands for a more development-oriented approach to IP, including:

• rejecting IP provisions and agreements that would limit a country's ability to establish and implement key social, cultural and environmental policies;

• calling for an international instrument to prevent the misappropriation of traditional knowledge (TK) and folklore; and

• demanding all WIPO activities to adequately consider and address their impact on sustainable development.

Background

Intellectual property rights (IPRs) are established solely by national laws and are therefore, in principle, only effective in their respective national territories. International recognition and protection of IPRs, however, is relevant for holders of IPRs seeking to exploit their

protected products and works across national boundaries. International agreements, therefore, have traditionally responded to calls by industrialized countries for certain minimum levels of IP protection and for recognition of the IPRs of their nationals in other countries.

WIPO, whose history dates back to the Paris Convention for the Protection of Industrial Property of 1883 and the Berne Convention for the Protection of Literary and Artistic Works of 1886, has been instrumental in facilitating these efforts towards increased international protection of IP. WIPO replaced BIRPI in 1970, undergoing structural and administrative reforms, but primarily reflecting the growing importance placed on IP, which Member States agreed should be promoted throughout the world. Its work programme and activities have thus focused on the progressive development of IP rules. Indeed, as the US, the EU and other exporters of IP shift the standard-setting agenda to various fora in order to establish more extensive IP protection, WIPO's responsiveness to the needs of the industry and business sectors have made it a focal point of the process towards globalization of IPRs.

In part, the close links between WIPO and IPR holders respond to a characteristic that distinguishes WIPO from most intergovernmental organizations and has a direct impact on its approach. About 90 per cent of WIPO's funding comes not from Member States but from the private sector, through the fees paid for the use of global IP protection systems which facilitate the registration of or filing for an IP right in several countries (IPRs Commission, 2002). The Patent Cooperation Treaty (PCT), one such system, for instance, accounts for 75 per cent of WIPO's total income. The largest users of the PCT system come from the US, Japan, Germany, the UK and France (WIPO, 2005). Although, as an intergovernmental organization, WIPO is answerable only to its Member States, concerns remain that, given its dependence on the business community for funding, WIPO tends to pursue the agenda of increasing IP protection and harmonization as its own (Shyamkrishna et al, 2004). Box 4.1 outlines WIPO's mandate, governance structure and operation and Appendix 2 (page 247) lists the three types of treaties it administers.

Since 1974, however, WIPO has also been a UN specialized agency. As such, it has responsibility 'for promoting creative intellectual activity and for facilitating the transfer of technology related to industrial property to the developing countries in order to accelerate economic, social and cultural development'. Ongoing discussions about the WIPO Development Agenda, which will be discussed below, have questioned whether the links between IP and sustainable development are indeed considered in WIPO activities. Its publications and activities continue to espouse the view of IP as a 'power tool' for development, a 'universal value' that unreservedly contributes to the progress of societies. Technical assistance programmes of the Economic Development Sector at WIPO are aimed primarily at building up the legal and administrative infrastructure required to protect IPRs. As a result, civil society organizations have criticized WIPO for often acting as a 'church of intellectual property' rather than looking at IP as an instrument of public policy.

A limited perspective on IP and sustainable development could be particularly problematic because, as opposed to early international IP rules that mostly codified already existing state practices and left many central concepts open for national interpretation, current efforts for increased international protection of IP rules seek provisions that significantly limit countries' policy space. As will be explained below, several instruments established or currently being negotiated in WIPO will result in significantly superior scope and levels of protection for IPRs. They will thus impact on national discretion to determine the types and scope of IPRs recognized, the limitations and exceptions to these rights, and the manner in which these rights are enforced. Several initia-

tives for international rules currently being debated at WIPO would indeed establish 'TRIPS-plus' standards, requiring signatories to implement more extensive standards and eliminating options and flexibilities currently provided by the TRIPS Agreement.

Selected WIPO Work Affecting Genetic Resources and TK

Although the highest decision-making powers, particularly for norm setting, are held by the General Assembly, one of WIPO's governing bodies, substantive discussion and consideration of proposed rules or specific IP issues takes place in a range of WIPO committees. Discussions in three committees are particularly relevant for genetic resource and TK issues: the Standing Committee on the Law of Patents (SCP), the Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore (IGC), and the Provisional Committee on Proposals Related to the WIPO Development Agenda (PCDA).

The Standing Committee on the Law of Patents (SCP)

Since 2000, work in the SCP has focused on the harmonization of substantive aspects of patent law; that is on the global standardization of substantive patentability requirements and criteria. In particular, some industrialized countries had put forth a proposal for a Substantive Patent Law Treaty (SPLT). The proposed SPLT would harmonize fundamental areas of patent law on which there are so far no international standards. The SPLT would eliminate the flexibility that WIPO Members enjoy, under existing international intellectual rules such as the TRIPS Agreement, to legislate in such areas. In this sense, its provisions can be considered 'TRIPS-plus', in other words going beyond the requirements agreed to in the WTO TRIPS Agreement. As a result, there has been significant opposition to such patent harmonization efforts by developing countries, with discussions now indefinitely suspended in the WIPO context. Nevertheless, substantive patent harmonization is still being addressed in formal meetings by the so-called Group B-plus – developed member States of WIPO plus other countries in the European Patent Organisation.

Substantive patent standards define, for example, the concept of 'invention' and the scope of protection granted by a patent. As a result, the proposed SPLT would, for example, by including a mandatory definition for the term 'invention', eliminate the available freedom for countries to determine the patentability for biological materials, including genes (Correa and Musungu, 2002). Currently, for example, living beings or 'biological materials found in nature' are not considered to be inventions in Brazil – even if isolated from the organism. In the US, on the other hand, an isolated and purified form of a natural product is considered an invention and can be patented. Such positions are perfectly consistent with TRIPS, which does not include definitions of any of the terms used in the Agreement.

For multinational companies with global markets, harmonized substantive patent law standards – and eventually a global patent system – would facilitate obtaining patents in different countries. In his 2005 written testimony on patent harmonization before the US Senate, Marshall C. Phelps, Jr, Corporate Vice President and Deputy General Counsel for Intellectual Property of the Microsoft Corporation, stated that:

Inventors who desire protection in a particular country must take steps to obtain protection within that jurisdiction. The costs and barriers to access posed by a multiplicity of national patent regimes – all sharing the same basic goal, but each imposing disparate administrative burdens on inventors – is something that industry and policymakers should care deeply about. (Phelps, 2005)

The Director General of WIPO, Dr Kamil Idris, in the memorandum that launched discussions on the proposed SPLT, noted that:

… technology-based, internationally focused, export-oriented enterprises need patents in a number of countries, which in turn need to provide effective patent systems if they are to attract investment and encourage technological development. … The current framework of the patent system consists of a national and regional patchwork of legal, organizational and administrative arrangements for obtaining and enforcing patents. It is evident that international trade and commerce and the movement of technology are hampered by a tangle of inconsistent regulations across national boundaries. … A more unified framework for obtaining patents worldwide would encourage more users to develop and commercialize their inventions on a truly international basis, with less fear that their work would not be evenly and effectively protected, thus fostering innovation and economic growth more effectively and at lower cost. (WIPO, 2001)

Early discussions of the SPLT were characterized by an asymmetrical participation of developing countries. Topics such as the costs and benefits of harmonization, the balance between right holders and the public interests in the proposed provisions, and the relationship between the patent system and other policy and regulatory issues, however, have become increasingly raised by developing countries and civil society organizations. In particular, developing countries have emphasized the importance of adequately addressing issues related to genetic resources and TK. For example, in discussions on the requirements of patent applications involving genetic resources, proposed text has been submitted to require applicants to disclose source and country of origin, as well as compliance with prior informed consent.

As discussed in other chapters, a major concern of developing countries about the international patent system is that it allows the granting of patents for inventions that use genetic material and associated knowledge without adequate consideration of the provisions of the Convention on Biological Diversity (CBD – see Chapter 5). The need for disclosure requirements that would increase transparency, enhance patent examination and quality, and prevent the misappropriation of genetic resources and TK have come up in various fora, including the SCP. Nevertheless, given the broader concerns about the impact of patent harmonization on sustainable development, the focus of SCP discussions has not been on the issue of disclosure. Moreover, the discrepancies between developing countries and the countries home to the Trilateral Patent Offices – the European Patent Office, the Japan Patent Office and the United States Patent and Trademark Office, where more than 85 per cent of all patent applications filed worldwide are processed – eventually led to a deadlock in negotiations. As mentioned, discussions on the proposed SPLT are thus effectively suspended in the WIPO context.

The Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore (IGC)

WIPO began work in 1998 on the IP aspects of access to and benefit sharing in genetic resources and of the protection of TK and folklore, through consultations with stakeholders, such as indigenous peoples and other local communities, civil society, governmental representatives, academics and the private sector. When issues related to genetic resources were raised by developing countries in the context of other WIPO negotiations and discussions, however, some Members considered these

issues required further exploration and discussion that could not take place in existing bodies in the organization (see also Chapter 3). As a result, in 2000 the WIPO General Assembly established the IGC as a forum in which discussions could proceed among Member States on IP issues that arise in the context of

• access to genetic resources and benefit sharing;

• protection of TK, whether or not associated with those resources; and

• the protection of expressions of folklore.

Once their links with IP were defined and examined, the understanding was that they would be mainstreamed in broader WIPO negotiations.

The IGC was welcomed by developing countries as a possibility to examine these issues and find solutions to satisfy Member States, and by indigenous peoples and other local communities (GRULAC, 2001). In particular, developing countries proposed that the IGC examine the extent to which IP systems could be adapted to improve their protection of genetic resources, TK and folklore; look at what new disciplines and provisions needed to be developed for a comprehensive protection of these resources at the international level; and devise and draft the necessary international instruments and model provisions for national legislative texts (African Group, 2001). The WIPO General Assembly eventually broadened the mandate of the IGC, instructing it to 'accelerate its work' and 'focus on the international dimension of IP, GR [genetic resources], TK and folklore', excluding 'no outcome, including the possible development of an international instrument or instruments in this field' (WIPO General Assembly, 2003).

The work of the IGC has proven a valuable source of information, enhancing the understanding of the different dimensions and implications of the issues of genetic resources, TK and folklore. The IGC has examined various technical matters concerning IP issues in mutually agreed terms for the fair and equitable sharing of benefits arising from the use of genetic resources, including through model IP clauses for contractual agreements on access to genetic resources and benefit sharing. It has also focused on the defensive protection of genetic resources – measures to ensure that IPRs do not allow the misappropriation of genetic resources. Its work has included technical studies on methods for requiring disclosure within patent applications consistent with WIPO obligations and the interrelation of access to genetic resources and disclosure requirements. This latter included options for model provisions and for procedures with regard to triggers of these requirements, prepared at the request of the CBD, as discussed in Chapter 7.

On TK, the work plan has included terminological and conceptual issues, the use of IPRs for the protection of TK and the defensive protection of TK (Box 4.2). For example, a toolkit was developed for managing the IP implications of the documentation of TK. TK is being documented for a variety of reasons, including preservation, but documented TK may also be more readily accessed and used without authorization if certain safeguard measures – which the toolkit explains – are not foreseen. Moreover, the IGC is currently discussing draft provisions on the protection of TK from misappropriation that offer in a 'coherent and focused form the kind of specific questions that may need to be weighed by policymakers at national, regional and international level, when considering the appropriate form and means of protection' (WIPO, 2006b).

However, there are increasing concerns on the part of developing countries that the work has not been successful in its primary objective, as it has not contributed to mainstreaming these issues, indeed that it may have proven a way to 'push them out of the way' both in WIPO and in other fora. Developing countries are still calling for an increase in the pace of negotiations and

more focused and result-oriented debates. In addition, there are worries that the drawn-out discussions in the IGC are being used by some developed countries to detract from initiatives on IP and genetic resources and TK undertaken in other WIPO bodies and international fora. For example, interventions by the US at the WTO recognize the importance of the issues of genetic resources and TK, but insist they must be addressed in the IGC. Moreover, from other perspectives, there is concern from some that this is drawing indigenous groups into an IP approach that is inappropriate for dealing with the substantial social and economic concerns they have.

Nevertheless, the IGC has developed extensive expertise on some aspects of the relationship between IP and genetic resources and TK, and its work has contributed significantly to the awareness and knowledge available on these issues. It has also engaged a wide range of stakeholders in its work. Over 120 organizations – including groups representing indigenous peoples and other local communities, non-governmental organizations, and groups representing industry and the private sector – have been accredited to the IGC as ad hoc observers. Member States of WIPO, moreover, have set up a voluntary fund to facilitate the participation of indigenous and local communities in the work of the IGC. WIPO Member States also contribute to the work through IGC activities such as the analysis of relevant national and regional legal frameworks, case studies, surveys, and comments on various substantive documents, as well as through occasional proposals and submissions.

As a result, the work of the IGC would play an important role in any comprehensive and effective steps to promote a mutually supportive relationship between the international IP regime and the protection of genetic resources and TK. To advance such steps, however, the work of the IGC requires increased focus on concrete measures to be taken at the international level and on supporting, rather than hindering, the related work taking place in other WIPO committees and other organizations.

The WIPO Development Agenda

The WIPO Development Agenda was launched in 2004 as an attempt to ensure WIPO activities and IP discussions are driven towards development-oriented results. Given the relevance of the organization's mandate and governance to its work, as seen above, it is not surprising that these are key elements of the WIPO Development Agenda proposals. The Group of Friends of Development, which has spearheaded the Development Agenda process and includes Argentina, Bolivia, Brazil, Cuba, Dominican Republic, Ecuador, Egypt, Iran, Kenya, Peru, Sierra Leone, South Africa, Tanzania and Venezuela, has presented a number of relevant proposals (Friends of Development, 2005). One suggestion, for example, is to critically analyse and, if necessary, review the mandate to overcome any possible impediment to the Development Agenda's balanced implementation. The disparity between the WIPO Convention and the organization's mandate as a UN specialized agency, the misinterpretation of the development dimension as technical assistance, and the lack of guidelines for incorporating development concerns into all WIPO activities were proposed as some of the specific issues to consider.

The Group of Friends of Development has also raised the need to strengthen the role of Member-driven structures in WIPO to avoid undue influence of IPR holders. Discussions have thus addressed potential changes to the current governance and oversight structures of WIPO, including through an independent evaluation and research office. More transparent and inclusive discussions would also require the increased participation of public interest non-governmental organizations in WIPO, which has traditionally focused its engagement with private sector groups (Figure 4.1).

Initiatives such as the WIPO Development Agenda also highlight some of the institutional advantages of WIPO as a forum for IP and

Figure 4.1 Perspectives on civil society participation in WIPO

sustainable development issues. As the US and other developed countries shift to bilateral trade negotiations for IP standard setting, the collaboration among developing countries and civil society organizations that promoted sustainable development issues and culminated in the WIPO Development Agenda process becomes more difficult.

The WIPO Development Agenda process aims to ensure all WIPO activities adequately take into account development concerns. WIPO has now acknowledged the need to guide its work in light of the international development objectives established by the UN, including the Millennium Development Goals and the Johannesburg Declaration on Sustainable Development. The conservation and sustainable use of biodiversity, which plays a critical role in overall sustainable development and poverty eradication, is essential in achieving these development goals. The Johannesburg Declaration, for example, acknowledged the importance of biodiversity to human wellbeing and the livelihoods and cultural integrity of people, and stated that the loss of biodiversity can only be reversed if local people benefit from the conservation and sustainable use of biological diversity, in particular in countries of origin of genetic resources, in accordance with the CBD. Moreover, it called for actions at all levels to integrate the objectives of the CBD into global, regional and national programmes and policies, in particular in those of the economic sectors of countries (WSSD, 2002). The Conference of the Parties of the CBD, moreover, has noted that the achievement of the Millennium Development Goals is dependent on the effective conservation of biological diversity, the sustainable use of its components, and the fair and equitable sharing of the benefits arising out of the utilization of genetic resources. It thus urged parties, governments and relevant intergovernmental organizations, as a contribution towards the Millennium Development Goals, to implement their activities in ways that are consistent with, and do not compromise, the achievement of the objectives of the CBD (CBD, 2004).

In addition, several of the specific Member State proposals have a direct link with biodiversity issues, particularly those of the African Group and the Group of Friends of Development in WIPO. For example, the African Group called on WIPO to examine the flexibilities under the TRIPS Agreement with a view to enabling developing and least developed countries to gain access to essential medicines and food. The African Group proposal states that:

[developing country] populations should also be enabled to have access to adequate food and nutrition in order to survive and live decently. Protection of the environment, biodiversity, genetic resources, access to benefit sharing, etc, should also be considered within this context (African Group, 2005).

The guidelines for norm-setting activities envisioned by the Group of Friends of Development, moreover, would require that all initiatives discussed at WIPO are compatible and supportive of other international agreements, including the CBD and the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA). Similarly, the assessment of the potential impacts of any norm-setting initiative would consider the effect on core development indicators such as access to essential products (seeds, for example), poverty alleviation, equity and protection of biodiversity.

In June 2007, the Provisional Committee on Proposals Related to a WIPO Development Agenda (PCDA), which is where discussions on the WIPO Development Agenda had been taking place, in what was called a 'major achievement' for sustainable development issues at WIPO, agreed on a number of the proposals that had been put forth by various Member States. It thus recommended specific

actions to the September 2007 WIPO General Assembly on issues such as technical assistance, norm setting, transfer of technology, studies on the impact of IP and institutional governance. In addition, the PCDA recommended the creation of a Committee on Development and Intellectual Property, which would develop a work programme relating to the approved recommendations and monitor, discuss and report on its implementation. This Committee would also be able to address other IP and development issues, agreed by members of the Committee itself or of the General Assembly.

In spite of several internal controversies that caused a deadlock on the approval of a new budget, the 2007 General Assembly did move forward on the WIPO Development Agenda. As recommended by the PCDA, it approved the creation of the new Committee on Development and Intellectual Property, which will meet twice during the following year. The main task of the new Committee will be the implementation of the PCDA consensus proposals, which were adopted. In particular, the General Assembly instructed the immediate implementation of a list of 19 proposals, based not on their higher priority but simpler execution in terms of financial and human resources.

Other WIPO Activities, Including Technical Assistance

Even if international provisions establish minimum requirements for national IP systems, sometimes limiting the room for countries to construct their IP system according to their particular needs and conditions, these provisions may provide facultative exceptions, allowing countries to opt between diverse approaches, or otherwise maintain 'flexibilities' for national policies. As discussed in Chapter 3, the TRIPS Agreement, for instance, allows WTO Members to define certain fundamental concepts in a manner they deem adequate. Article 27.3(b) of the TRIPS Agreement, moreover, obliges WTO Members to provide protection for plant varieties, but allows them to choose between providing patent or sui generis protection. The use of the flexibilities provided by certain international agreements, therefore, becomes essential to 'claw back' some of the policy space lost to minimum or harmonized standards.

WIPO, as one of the main providers of technical assistance to developing countries in the design and implementation of their national IP regimes, plays a fundamental role in the extent to which these countries become aware of the existence and importance of flexibilities in international IP agreements. Between 1996 and 2000, WIPO assisted 119 developing countries and regional organizations in the preparation of 214 draft IP laws. During that period, WIPO also prepared draft provisions to amend and modernize existing laws and made comments and suggestions on 235 draft laws received from 134 developing countries and regional organizations in developing countries (Pengelly, 2005). However, its approach to technical assistance, which it also provides for the WTO, has come under considerable criticism (Box 4.3).

In its proposals on the WIPO Development Agenda, the Group of Friends of Development recognized the central importance of WIPO in the provision of IP-related technical assistance and capacity building, not only by virtue of its own mandate, but also in light of its agreement with the WTO. While acknowledging that WIPO has made significant strides in providing developing countries with technical assistance, the Group of Friends of Development emphasized that more needs to be done to ensure that such assistance is useful to development objectives, particularly by ensuring the technical assistance programmes focus not only on the implementation and enforcement of obligations, but also on the use

of in-built rights and flexibilities in international treaties. Civil society organizations, however, have been more critical of the type of technical assistance provided by WIPO (MSF, 2003).

Conclusion

The launch of the WIPO Development Agenda was considered a milestone in the IP and development debate. It was the first time WIPO was called upon to expressly address its role with respect to internationally agreed development goals. Its Member States voiced agreement on the need to view IPRs as a means, not an end in themselves, and to ensure the work of WIPO contributes to the use of such a means in a manner coherent with development and other public policy concerns. The links between IP and genetic resources and TK make such an approach particularly significant.

IP and genetic resources and TK issues are relevant and important, and have been raised and discussed in a range of WIPO bodies. Many developing countries and civil society organizations consider, however, that more tangible measures are still required to ensure that IP rules and activities in WIPO advance relevant international objectives and principles. As discussions continue in the IGC – whose mandate will once again need to be considered in 2007 – the challenge for the organization and its Member States will be to agree on concrete steps towards the international recognition and protection of TK and folklore. Similarly, as consideration continues regarding the changes needed in both the role and attitude of WIPO to truly serve its goal – the promotion of innovation for the public interest (Boyle, 2004) – a critical undertaking will be to modify WIPO's vision, work programme and activities to adequately recognize its responsibility on issues related to the protection of biodiversity and the promotion of food security. The next two chapters discuss the international agreements on biodiversity in general and for food and agriculture in particular and the role IP plays in them.

Resources

There is a range of resources for following up on various aspects of the issues covered by WIPO, including, on WIPO generally: Musungu and Dutfield (2003), Boyle (2004) and the WIPO website, www.wipo.int. See also:

• South Centre and CIEL Intellectual Property Quarterly Update, available at www.southcentre.org and www.ciel.org.

• IP-Watch website – www.ip-watch.org.

• Consumers' Project on Technology WIPO webpage – www.cptech.org/ip/wipo.

• Third World Network website - www.twnside.org.sg/.

• Bridges Weekly Digest, available at www.ictsd.org/weekly/index.htm.

On SCP and SPLT: Correa and Musungu (2002), GRAIN (2003) and Correa (2004a).

On the IGC: Lettington and Nnadozie (2003), CIEL and South Centre (2005) and the WIPO IGC Accredited Observers' webpage, www.wipo.int/tk/en/igc/ngo/ngopapers.html.

5
Safeguarding Biodiversity: The Convention on Biological Diversity (CBD)

Susan Bragdon, Kathryn Garforth and John E. Haapala Jr

Biodiversity encompasses the whole of life on this planet. Today's biodiversity has developed from over four billion years of evolution. Yet the actions and development of one species, ours, is now the biggest threat to the immense biodiversity on the planet – something of irreplaceable value in itself as well as vital for our wellbeing, whether for our food, health or climate. Moves to safeguard all aspects of biodiversity do not take place in a vacuum nor are they uninfluenced by social and economic developments. Indeed, as this and the next chapter show, and earlier chapters have indicated, the expansion of intellectual property (IP) into the biological sphere and the reactions to that have overshadowed at times and helped shape the types of international agreements affecting IP and biodiversity. This chapter gives a background to the negotiation of the Convention on Biological Diversity and its Cartagena Protocol on Biosafety, their key aims, and issues arising in their implementation.

Introduction and background

A growing appreciation of the monetary and non-monetary value of genetic resources – catalysed by enormous strides in molecular biology and genetic engineering – provided the backdrop to the negotiations of the Convention on Biological Diversity (CBD, signed May 1992, entered into force 1993). An understanding of the dynamics behind increasing conflict over rights and responsibilities for these resources is necessary before discussing the CBD itself. It is also relevant to the discussion of the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA or the Treaty) in Chapter 6.

The current international debate on legal regimes for genetic resources has its origins in the late 1970s and early 1980s, when developing countries became concerned by moves in industrialized countries to extend IP protection to living organisms. New legislation, court rulings and international agreements such as UPOV (see Chapter 2) had made it possible to

obtain plant breeders' rights and patent protection over living organisms in the US and many European countries. Prior to this time, economic and political interest had rested at the species level, as the species was the relevant unit at which economic value could be recognized. The ability to gain IP protection over genetic resources gave them economic value and resulted in increased political interest at both the national and international levels. Initially, however, this expanding scope of IP protection only addressed one side of the value chain – biotechnology and plant breeding – without addressing the other side – conservation and traditional development (Bragdon et al, 2005; Bragdon, 2004).

While IP protection expanded in scope most quickly in developed countries, the majority of biodiversity is located in developing countries, although it is not evenly distributed. Traditionally, genetic resources have been considered common resources or common heritage and were freely moved around the world (Brockway, 1979; Crosby, 1986). Politically, this was not a problem while the sources of germplasm were under colonial rule or while genetic resources appeared to belong to no one. But with the dismantling of the colonial system after World War II and the expansion of intellectual property law in Northern countries, genetic resources – and plant genetic resources in particular – became 'politically salient' (Stenson and Gray, 1999, p15).

The concern of developing countries focused on the free flow of genetic resources along a predominantly developing country to industrialized country pathway, with no flow of benefits back to developing countries when research on those resources led to commercial products protected by patents or plant breeders' rights. The focus was on genetic resources collected for pharmaceutical research, since when this research resulted in a commercialized product it tended to generate much more value for the developer than would genetic resources used in agricultural research. Furthermore, collections of plant genetic resources for food and agriculture had also been of great benefit to developing countries (Bragdon, 2004, pp58–59; see also Chapter 6). Nonetheless, developing countries felt that their contributions to the conservation and development of these genetic resources were not being recognized.

When developing countries debated the ownership and control of plant genetic resources at the UN Food and Agriculture Organization (FAO) (Chapter 6), the debate was highly politicized, with concerns about intellectual property rights (IPRs) and national germplasm embargoes (Mooney, 1983). At the FAO Conference in 1983, developing countries succeeded in forcing through a resolution creating the International Undertaking on Plant Genetic Resources (IU – see Chapter 6). The IU declared plant genetic resources to be the common heritage of mankind, meaning they should be free and open to everybody. It made it clear that this open availability was to apply to all plant genetic resources, including 'special genetic stocks', which was interpreted to include the proprietary lines of breeders (Article 2). Furthermore, in the resolution by which the IU was adopted, Member States recognized that 'plant genetic resources are a heritage of mankind to be preserved, and to be freely available for use, for the benefit of present and future generations'. The aim, then, was to ensure that it was not just genetic resources from the South that could be freely accessed but that all plant genetic resources were subject to free access. The acrimonious debate on access to and the ownership and control of plant genetic resources during the adoption of the IU and its further refinement was dubbed the 'seed wars' by the Wall Street Journal (Kloppenburg and Kleinman, 1988).

While the IU was not a legally binding instrument, it represented an effort by developing countries to prevent access to plant genetic resources from being restricted by different forms of IP protection. Because of its rejection

of IPRs, eight developed countries1 refused to adhere to the IU, perceiving it to be contrary to their economic interests. The rejection of the IU by these countries meant that the free flow of genetic resources from South to North continued largely unabated, and developing countries continued to feel that access to products for research based on genetic resources would remain encumbered. Another approach was needed.

In an effort to resolve the conflict between the IU and IPRs on genetic resources, three interpretations of the IU were made during the late 1980s and early 1990s. The revisions included calling for farmers' rights, an acknowledgment of plant breeders' rights and a statement that nations have sovereign rights over their plant genetic resources.

CBD origins

The CBD's origins fall roughly into categories corresponding to what became its three objectives. One major source was conservationist concerns that existing international law for the protection of wildlife was a patchwork that covered only selected issues, areas and species (Bragdon, 2004, p15). While the idea of negotiating an umbrella convention that would harmonize existing international conservation treaties was quickly dropped due to the 'numerous practical, political and legal obstacles' it posed (McGraw, 2002, p12), proponents of a conservation rationale did succeed in creating an agreement that embraces an ecosystem approach to conservation (see also Chapters 6 and 8). The ecosystem approach embodies a broader concept of nature and its value, including the full diversity of life at the level of genes, species and ecosystems. For this reason, it should result in the protection of many elements of biodiversity not covered by preexisting international or national laws. The US, an initial supporter and instigator of the call for an international treaty, was motivated primarily by such conservation concerns (McGraw, 2002, p11; McConnell, 1996, p5; Bragdon, 1992).

Conservation of biological diversity may have provided the impetus for the initiation of negotiations, but the purpose and scope of the Convention changed as discussions got underway. Notably, developing countries were able to secure concessions that they had been unable to secure in other fora (McGraw, 2002, p7). This included consideration of the economic aspects of conservation, which take two broad forms in the Convention: sustainable use and access issues.

The second origin of the CBD, therefore, was a move to incorporate the goal of sustainable use of biological resources into conservation policy, recognizing the need of local people living amid biodiversity for sustainable development, and hence the need to mobilize support for conservation by providing local benefits. Distinguishing sustainable use from conservation emphasizes the desire of developing countries to use their biodiversity in their economic development (Glowka et al, 1994, pp1 and 4; Bragdon, 2004, p15; Bragdon, 1996).

Finally, many developing countries insisted that the negotiations on the Convention include:

… obligations and measures on three types of access: access to genetic resources, which they wished to have recognized as subject to national authority; access to relevant technology, stressing that it includes biotechnology; and access for the providing States to benefits ultimately gained from the use of genetic material in the development of biotechnology. (Glowka et al, 1994, p5).

These access issues resulted in some of the most contentious aspects of the negotiations. They also resulted in significant shifts in international law (Bragdon, 1992). As will be discussed in more detail below, Article 3 of the

Convention provides that states have sovereignty over their resources. When read in conjunction with Article 15(1), this includes state sovereignty over genetic resources. Furthermore, Article 15(3) requires Parties to 'facilitate access to genetic resources for environmentally sound uses', another change in international law. After failing with the common heritage approach in the IU, developing countries changed tactics, seeking and obtaining the right to control access to genetic resources.

In contrast to the IU negotiations that took place under the FAO, and that were normally led by ministries of agriculture, negotiations for an international convention on biological diversity were conducted under the aegis of the United Nations Environment Programme (UNEP), beginning in May 1989 and were generally led by ministries of the environment. An ad hoc Group of Legal and Technical Experts and an Intergovernmental Negotiating Committee together met seven times to conduct the negotiations that resulted in the CBD. Controversial issues during the negotiations included biotechnology, IPRs and financing (McConnell, 1996). The negotiations ran through the United Nations Conference on Environment and Development (commonly known as the Earth Summit) in Rio de Janeiro in June 1992, but in the end the Convention was concluded on time and an astonishing 156 countries signed the CBD during the Earth Summit (McConnell, 1996, p111). The Convention entered into force 18 months later, having received the necessary 30 ratifications, and, as of mid-2007, the CBD has achieved near-universal ratification, with 190 Parties.

A notable non-Party to the Convention is the US. Despite having been an initial proponent of the negotiations, the US was indicating its displeasure with the direction of the negotiations prior to the final text being concluded. Early opposition focused on the inclusion of biotechnology within the scope of the Convention, a move which the US opposed with increasing vehemence (McConnell, 1996). Subsequent opposition included concerns about the provisions on IPRs. Initially, the US declined to sign the CBD, citing concerns with Article 16 and its provisions on IPRs in particular, but in 1993 President Clinton did sign the Convention and sent it to the Senate for ratification, where it is still pending in the Senate Committee on Foreign Relations. The US does attend CBD meetings as a non-Party and is able to exert its influence on CBD processes through other CBD Parties and discussions taking place in other fora such as the WTO.

The Convention

The scope of the CBD includes all aspects of biological diversity, which it defines as meaning the 'variability among living organisms from all sources including, inter alia, terrestrial, marine and other aquatic ecosystems and the ecological complexes of which they are part; this includes diversity within species, between species and of ecosystems' (Article 2). The Convention contains three objectives:

the conservation of biological diversity, the sustainable use of its components, and 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)

The CBD is generally considered to be a framework convention that 'creates a global structure to promote continued international cooperation and to support national implementation'; that allows for its further development through the negotiation of annexes and protocols; and that builds upon existing agreements rather than absorbing them (McGraw, 2002, pp20–22). It emphasizes the development of national biodiversity strategies and action plans as the basis for each country's obligations (Article 6(a)): 'A national strategy will reflect how the country intends to fulfil the objectives of the Convention in light of specific national circumstances, and the related action plans will constitute the sequence of steps to be taken to meet these goals.'2 This approach was advocated initially by the British delegation during the Convention's negotiations, in contrast to the strong desire of France for a more supra-national, top–down approach of global lists of priority areas and species in need of protection (McConnell, 1996).

The text of the Convention consists of a preamble, 42 articles and two annexes (Box 5.1). Since 2000, there has also been a subsidiary instrument – the Cartagena Protocol on Biosafety. The work of implementing the CBD is carried out by the Conference of the Parties (COP) and its subsidiary bodies (Box 5.2), as well as by the domestic implementation of the Convention by states. The CBD is legally binding for the countries that have ratified it. However, for the Convention to be implemented domestically, ratifying countries must adopt appropriate legislation and regulations or bring existing ones into harmony with it.

Key provisions of the CBD

The broad scope of the Convention means that it is impossible to explore all its provisions in detail. Instead, we shall focus on five areas: access to genetic resources and benefit sharing (ABS); traditional knowledge (TK), innovations and practices; technology transfer; agricultural biodiversity; and implementation, compliance and enforcement. This section concludes with a brief consideration of some other provisions in the Convention and their links to IPRs.

Access to genetic resources and benefit sharing

Article 15 of the Convention addresses 'Access to genetic resources'. Paragraph 1 of the article reaffirms the principle from Article 3 of the Convention of state sovereignty over resources. Importantly, however, these sovereign rights now extend to genetic resources (although one could argue that such rights were already implicit in international law prior to the creation of the Convention). The paragraph explicitly vests the authority to determine access to genetic resources with national governments, subject to national legislation. This paragraph helps to explain the rationale behind granting states sovereignty over their genetic resources:

Countries could now set the terms for access to these resources, thus allowing them to profit from their biodiversity, further encouraging conservation. The CBD was thus based on both a premise – that developing countries had an equitable right to their own resources – and a promise – that these resources could be used to generate financing for development and conservation. (Garforth and Cabrera, 2004, p7)

Article 15 is important, therefore, not just for its economic aspects related to benefit sharing but also for how these are intended to also support the conservation and sustainable use of biodiversity.

Paragraph 2 of the article states that each Party is to endeavour 'to create conditions to facilitate access to genetic resources'. As

mentioned above, this can also be seen as a major shift in international law as no such obligation to facilitate access existed previously. While perhaps somewhat unclear in its wording, paragraph 3 of the article means that the provisions of Articles 15, 16 and 19 do not apply to genetic resources accessed prior to the entry into force of the Convention. Essentially, it incorporates the principle of non-retroactivity, in other words that new legal rules and international agreements do not apply to past actions (Glowka et al, 1994, p79). As will be

Safeguarding Biodiversity

discussed below, Article 15(3) left open the question of what ABS rules should apply to ex-situ collections of genetic resources accessed prior to the creation of the Convention.

Article 15 also states the general principles on which access must be granted, namely mutually agreed terms and prior informed consent (paragraphs 4 and 5). Paragraph 7 requires the Parties to the Convention to take measures for sharing the benefits from the use of genetic resources with the Party providing access to such resources. The Convention implies that the specific bargain between access to the resources and the sharing of benefits will be open for negotiation between the individual user and provider. For this reason, the Convention is said to favour the negotiation of bilateral ABS contracts between resource

provider and resource user. Finally, under paragraph 6, research based on genetic resources provided by Parties to the Convention should involve the full participation of such Parties and, where possible, be conducted in these Parties.

Access to genetic resources and benefit sharing is intimately connected to agriculture and food issues, although most of the CBD negotiators came from ministries of environment rather than ministries of agriculture. They had little knowledge of the characteristics of genetic resources for food and agriculture and all countries' interdependence on one another for these resources (Bragdon, 2004, p15; see also Chapter 6). For these negotiators, the classic ABS scenario involved scientists searching the rainforest for an organism that may contain the next cure for cancer or AIDS. Yet genetic resources and genetic diversity are also of critical importance in agriculture. That said, however, the ABS principles in the CBD are not the only ones that address access to genetic resources for food and agriculture and consequent benefit sharing.

When the negotiators of the CBD agreed in Nairobi in May 1992 on the text of the Convention to be advanced to the Earth Summit, they also adopted a resolution on 'The Interrelationship between the Convention on Biological Diversity and the Promotion of Sustainable Agriculture'. This resolution recognized:

… the need to seek solutions to outstanding matters concerning plant genetic resources within the Global System for the Conservation and Sustainable Use of Plant Genetic Resources for Food and Sustainable Agriculture, in particular: (a) access to ex-situ collections not acquired in accordance with this Convention; and (b) the question of farmers' rights (paragraph 4).

To this end, the FAO began negotiations in the mid-1990s to turn the IU into a binding treaty that is in harmony with the CBD. The result was the International Treaty on Plant Genetic Resources for Food and Agriculture. The Treaty is discussed in more detail in Chapter 6, but it is important here to note its relationship to the ABS provisions of the CBD. The Treaty creates a Multilateral System of Access and benefit sharing that covers the 35 food crop species and 29 forage species listed in Annex I to the Treaty. While ABS under the Treaty is still founded on the principle of state sovereignty over genetic resources (Article 10), access to the genetic resources in the Treaty's Multilateral System is done in accordance with a standard Material Transfer Agreement that also sets the terms for benefit sharing. Individual contract negotiations for each instance of access and benefit sharing are thus no longer required for the species listed in Annex I. This responds to the concern that the transaction costs for bilateral negotiations between providers and users of genetic resources would be so high under the CBD that they would inhibit plant breeding, inadvertently jeopardizing food security. Instead, the Treaty, rather than the CBD, now sets the rules for access to and benefit sharing from these specific crops and forages (see also Chapter 6; Moore and Tymowski, 2005; Garforth and Frison, 2007; Bragdon, 2004).

That said, there are any number of genetic resources that are relevant to food and agriculture that are not covered by the Treaty's Multilateral System. This includes plant genetic resources not listed in Annex I to the Treaty as well as animal genetic resources and aquatic genetic resources, among others (Box 5.3).

TK, innovations and practices

Another key provision in the CBD is Article 8(j), which obliges the Parties to the Convention, subject to their national legislation, to:

… respect, preserve and maintain knowledge, innovations and practices of indigenous and local communities embodying traditional lifestyles relevant for the conservation and sustainable use of biological diversity, promote their wider application with the approval and involvement of the holders of such knowledge, innovations and practices, and encourage the equitable sharing of the benefits arising from the utilization of such knowledge, innovations and practices.

This provision is included in the article on 'in-situ conservation' and is frequently summarized as addressing TK, innovations and practices of indigenous and local communities.

The implementation of Article 8(j) has covered a number of different areas including links to Article 15 on ABS. The TK of indige-

nous peoples and local communities can be very valuable in helping to identify genetic resources of potential interest for research programmes and product development. Furthermore, because of their long-term association with, as well as sustainable use and management of, their local environment, indigenous peoples and local communities may themselves have contributed to the development of the genetic resources. The CBD recognizes state sovereignty over genetic resources; however, this state authority does not extend to TK. Parties are required to respect, preserve and maintain TK with the approval and involvement of the knowledge holders, which are the indigenous peoples and/or local communities themselves. In implementing this provision, Parties such as Peru and the Philippines have required those seeking access to TK to do so on similar terms to those for accessing genetic resources, in other words requiring the prior informed consent of and the negotiation of mutually agreed terms with the knowledge holder.

At their fifth meeting in 2000, the Parties to the Convention adopted a programme of work for Article 8(j) (decision V/16). The programme of work contains a number of elements and tasks concerning participatory mechanisms for indigenous and local communities; the equitable sharing of benefits; monitoring; legal elements; traditional cultural practices for conservation and sustainable use; and exchange and dissemination of information.

At their seventh Conference in 2004, the Parties adopted 'Elements of a Plan of Action for the Retention of Traditional Knowledge, Innovations and Practices Embodying Traditional Lifestyles Relevant for the Conservation and Sustainable Use of Biological Diversity' (part E of decision VII/16). Work is focused on developing technical guidelines for documenting TK; developing indicators for the retention and use of TK; methods and measures to address the underlying causes of the loss of TK; and the development of a Code of Ethical Conduct to ensure respect for the cultural and intellectual heritage of indigenous and local communities. The Plan of Action includes the further development of sui generis systems to protect TK based on customary laws of indigenous peoples (SCBD, 2007, p2).

The Working Group on Article 8(j) is mandated to collaborate with the ABS Working Group in the negotiation of an international regime on access and benefit sharing (see below). The form of and process for this collaboration is yet to be determined (Box 5.4 and Chapter 8, Box 8.4). Finally, the Working Group on Article 8(j) has also contributed to the consideration of genetic use restriction technologies (GURTs), which is also covered in more depth below.

Access to and transfer of technology

Article 16 addresses access to and transfer of technologies that are relevant to the conservation and sustainable use of biodiversity or that make use of genetic resources and do not cause significant damage to the environment (Article 16(1)). This article contains the only explicit reference in the Convention to IP rights. The article aims to strike a balance between the need to secure access to and transfer of technology on the one hand, and to respect IPRs on the other.

Article 16(2) begins by stating that access to and transfer of technology 'to developing countries shall be provided and/or facilitated under fair and most favourable terms, including on concessional and preferential terms where mutually agreed, and, where necessary, in accordance with the financial mechanism established by Articles 20 and 21'. This or similar language has become something of a norm in international law. Similar commitments to technology transfer can be found in the UN Convention on Climate Change (Article 4(5)), the Montreal

Protocol on Substances that Deplete the Ozone Layer (Article 10A), the UN Convention to Combat Desertification (Article 18(1)), and the Johannesburg Plan of Implementation from the World Summit on Sustainable Development (paragraph 105).

Paragraph 2 of Article 16 goes on to provide that for technology subject to patents or other IPRs, such access and transfer must be provided 'on terms which recognize and are consistent with the adequate and effective protection of IPRs'. The inclusion of the phrase 'adequate and effective' makes a direct link to the TRIPS Agreement, which was being concluded at the same time the CBD was finalized:3

According to the preamble of the TRIPS Agreement … the agreement was inspired by the need for new rules and disciplines in a number of areas relevant to IP, including adequate standards concerning the availability, scope and use of IPRs, as well as effective means to enforce them. (Glowka et al, 1994, p89; see also the first recital of the preamble to TRIPS as well as paragraphs (b), (c) and (d) of the second recital).

The terms 'adequate' and 'effective' are not defined in either the TRIPS Agreement or the CBD. One interpretation of 'adequate' is that it reflects the intention of the drafters 'not to create the system of IPR protection that would be considered "optimum" by particular right holders groups, but one that is adequate to protect the basic integrity of the trading system' (UNCTAD-ICTSD, 2005, p10). The lack of clarity over these terms has created tension between developed and developing countries, with the former group wishing to maintain its competitive technological edge and the latter group desiring to gain access to technology and also asserting that the level of IP protection 'should be tailored to a country's economic and technological development', the rationale being that standards of protection that are too high will hinder a country's development (Glowka et al, 1994, pp89 and 91). The situation has evolved since the negotiation of the Convention, however, and developed and developing countries should not be regarded as discrete blocs with homogeneous positions. Alliances between North and South can and do occur.

Paragraph 4 of Article 16 of the CBD requires each Party to take measures with the objective that the private sector will facilitate 'access to, joint development and transfer of technology … for the benefit of both governmental institutions and the private sector of developing countries and in this regard shall abide by the obligations included in paragraphs 1, 2 and 3 above'.

The final paragraph of Article 16 attempts to provide a counterbalance to paragraph 2. It states that the Parties shall cooperate over IPRs, subject to national legislation and international law, 'in order to ensure that such rights are supportive of and do not run counter to [the Convention's] objectives'. The article as a whole attempts to reconcile two very different perspectives on IPRs and in the process creates rather ambiguous language. Perhaps as a testimony to its ambiguity, the biotechnology industry has worried that the protection is too weak (Rhein, 1992)4, while some civil society organizations claim the language is too strong. Many developing countries argue that the application of existing IP systems hinders the transfer of technology to the developing world and unfairly disregards the contributions of generations of farmers and indigenous peoples to the world's plant genetic resources, which underpin global food security. These countries have objected to the expansion of IPRs over new crop varieties and other products based on genetic resources, and they proposed that the Convention provide for, or authorize, restrictions on IPRs. Some developed countries, on the other hand, argue that strong universal protection of IPRs would stimulate technology

and investment in research and development in developing countries, indirectly increasing the incentives to conserve biological diversity (Fowler et al, 2001, p479). The language on which negotiators eventually agreed does not entirely resolve these differing perspectives on the role of IPRs in achieving the Convention's objectives (UNESCO, 2002).

At their seventh meeting in 2004, the Conference of the Parties adopted a programme of work on technology transfer and technological and scientific cooperation (annex to decision VII/29) with four elements: technology assessments, information systems, creating enabling environments, and capacity building and enhancement. Each element has a number of objectives, operational targets and activities. Activities include such things as preparing transparent impact assessments and risk analysis of the potential benefits, risks and associated costs of the introduction of technologies (paragraph 1.2.1); implementing proposals to enhance the Clearing-House Mechanism as a central mechanism in technology transfer (paragraph 2.1.4); preparing technical studies on the role of IPRs in technology transfer (paragraph 3.1.1); and providing financial and technical support as well as training to enable the conduct of national technology assessments (paragraph 4.1.1). Implementation of this programme of work is still in its early stages, although the Secretariat has prepared a draft technical study responding to paragraph 3.1.1 (CBD, 2006c).

Agricultural biodiversity

The CBD's scope is all types of biodiversity and there is no one article in the Convention that relates specifically to agricultural biodiversity. Countries recognized the interrelationship between the Convention and the promotion of sustainable agriculture in Resolution 3 of the Nairobi Final Act by which the final text of the CBD was adopted (see above). Consideration of agricultural biodiversity by the Conference of the Parties has covered a broad range of topics, including pollinators, soil biodiversity, animal genetic resources, trade liberalization and GURTs. Much of the work on agricultural biodiversity under the Convention has been carried out in collaboration with the FAO. Furthermore, with the conclusion at the FAO of the International Treaty on Plant Genetic Resources for Food and Agriculture, the Parties to the CBD recognized the important role the IT will play, in harmony with the CBD:

… for the conservation and sustainable utilization of this important component of agricultural biological diversity, for facilitated access to plant genetic resources for food and agriculture, and for the fair and equitable sharing of the benefits arising out of their utilization. (decision VI/6, paragraph 2)

In decision V/5, the Parties adopted a multi-year programme of work on agricultural biodiversity. The decision describes the scope of agricultural biodiversity as including:

… all components of biological diversity of relevance to food and agriculture, and all components of biological diversity that constitute the agro-ecosystem: the variety and variability of animals, plants and micro-organisms, at the genetic, species and ecosystem levels, which are necessary to sustain key functions of the agro-ecosystem, its structure and processes. (paragraph 1 of the Appendix to Annex 5 to decision V/5)

The objectives of the programme of work are:

• to promote the positive effects and mitigate the negative impacts of agricultural systems and practices on biological diversity in agro-ecosystems and their interface with other ecosystems;

• to promote the conservation and sustainable use of genetic resources of actual and potential value for food and agriculture; and

• to promote the fair and equitable sharing of benefits arising out of the use of genetic resources (paragraph 2 of Annex 5).

The programme of work includes four elements: assessments, adaptive management, capacity building and mainstreaming, although it is scheduled for an in-depth review at the ninth Conference of the Parties in 2008. While it is impossible to consider all aspects of agricultural biodiversity addressed by the Convention, a few are particularly relevant in the context of this book, notably GURTs.

Genetic use restriction technologies

GURTs (Box 5.5) first came to public attention in the late 1990s with a US patent on genetically modified plants that produced sterile seeds.

GURTs are not commercially available, perhaps in part because of decisions taken by the Parties to the CBD. In the decision of the Fifth COP (COP-5), the Parties adopted what is frequently considered to be a de facto moratorium on the use of GURTs. The Parties recommended that:

… in the current absence of reliable data on GURTs, without which there is an inadequate basis on which to assess their potential risks, and in accordance with the precautionary approach, products incorporating such technologies should not be approved by Parties for field testing until appropriate scientific data can justify such testing, and for commercial use until appropriate, authorized and strictly controlled scientific assessments with regard to, inter alia, their ecological and socioeconomic impacts and any adverse effects for biological diversity, food security and human health have

been carried out in a transparent manner and the conditions for their safe and beneficial use validated. (decision V/5, paragraph 23)

Since this decision, there has been an ongoing tug of war between civil society groups who seek to maintain the moratorium and who call for a complete and outright ban on GURTs and certain governments, such as those of Australia, Canada, New Zealand and the US, which have advocated allowing case-by-case assessments of whether plants incorporating GURTs could be used. At COP-8 in 2006, the Parties reaffirmed the COP-5 decision on GURTs (decision VIII/23, part C, paragraph 1). It seems unlikely, however, that this is the end of the debate, particularly as the COP-8 decision calls for further research on the potential impacts of GURTs.

Implementation, compliance and enforcement

As a framework for international cooperation on biodiversity, the CBD relies on its Parties (national governments) to adopt or change legislation to give effect to the Convention. The terms of the CBD are legally binding on its country Parties, but the Convention's provisions do not generally set specific requirements to be undertaken by them. This is unlike other international agreements, such as the Convention on International Trade in Endangered Species of Fauna and Flora (CITES), which has specific trade restrictions and requirements for specific lists of species. The CBD sets general requirements to meet its three objectives and then largely leaves it to individual states to determine how best to implement these provisions in their respective jurisdictions (McGraw, 2002, pp20–21). A number of these requirements are qualified by phrases such as 'as far as possible and appropriate' and 'subject to its national legislation', and some ascribe the near-universal ratification of the Convention to its lack of effective means of monitoring or enforcing compliance with its provisions (McGraw, 2002, p24).

The CBD does not include a specific compliance mechanism akin to the Compliance Committee under the Biosafety Protocol (discussed in more detail below). That said, there are mechanisms for dispute settlement as well as a provision on liability and redress. Article 27 addresses the settlement of disputes. It creates a graduated response to resolving disputes, first requiring the parties concerned to seek a solution by negotiation, then allowing a third party to mediate or provide good offices if negotiation has not been successful. Paragraph 3 allows the Parties to agree to submit disputes to arbitration in accordance with Part 1 of Annex II to the Convention and/or to the jurisdiction of the International Court of Justice. If the parties to a dispute have not submitted to either of these procedures, the dispute is to be submitted to conciliation in accordance with Part 2 of Annex II unless the parties agree otherwise. None of these dispute settlement mechanisms has been used to date, perhaps because the Convention leaves much of the specifics of its implementation to be determined by each country in light of its own domestic circumstances.

If a dispute under the CBD were ever to be decided by the International Court of Justice, the losing party to the dispute would not necessarily face economic sanctions for not complying with the Court's ruling. This lack of economic consequences for non-compliance with the CBD (and many other multilateral environmental agreements, with notable exceptions such as CITES) is frequently said to give the Convention less 'bite' than the dispute settlement mechanism under the WTO, which allows for compensation and the suspension of concessions in cases of non-compliance with a ruling of one of its dispute settlement bodies (Article 22 of the Dispute Settlement Understanding). There are a number of disad-

vantages to the dispute settlement mechanism of the WTO, however, and it should not necessarily be regarded as a model to be followed elsewhere (Charnovitz, 2001). Rather than rely on coercive measures as does the WTO, the CBD and other environmental agreements tend to use positive incentives and transparency or 'sunshine' methods to encourage compliance (Weiss, 2000, p463).

Article 14(2) of the CBD requires the COP to examine, 'on the basis of studies to be carried out, the issue of liability and redress, including restoration and compensation, for damage to biological diversity, except where such liability is a purely internal matter'. To date, the Parties have largely engaged in an information gathering exercise on legislation, measures, agreements and case studies relating to liability and redress for damage to biological diversity and have held two meetings of experts to discuss the issue and review information. It seems unlikely that any sort of more formal liability and redress mechanism will be negotiated for the Convention itself, although important liability and redress negotiations are ongoing under the Biosafety Protocol (see below).

Leaving states to implement measures to achieve the Convention's three objectives also places the onus on these states to ensure compliance with their domestic measures. This has created a great deal of frustration for developing countries which face difficulties in monitoring and enforcing the terms of ABS agreements negotiated under their national laws. As agreements in private international law, ABS contracts are not generally subject to the dispute settlement provisions of the CBD.5

Technology, research and benefit sharing

A number of other provisions in the Convention involve technology, research and the sharing of benefits and could also relate to IPRs. These include Article 12(c), which deals with research and training and promotion and cooperation 'in the use of scientific advances in biological diversity research in developing methods for conservation and sustainable use of biological resources'; Article 17, which deals with exchange of information; and Article 18, which covers technical and scientific cooperation.

In their decision on 'Scientific and Technical Cooperation and the Clearing-house Mechanism', the Parties at their eighth Conference in 2006 invited 'Parties and other Governments, as appropriate, to provide free and open access to all past, present and future public-good research results, assessments, maps and databases on biodiversity, in accordance with national and international legislation' (decision VIII/11, paragraph 3). This decision points to the growing links being made between copyright, open access to research and publications, and biodiversity (Box 5.6 and Chapter 8).

Article 19 on the 'handling of biotechnology and distribution of its benefits' also contains provisions with links to IPRs. Article 19(1) provides that Parties shall take appropriate measures to provide for the effective participation in biotechnological research by Parties, especially developing countries, that provide the genetic resources for such research, in such Parties where feasible. Article 19(2) requires Parties to 'take all practicable measures to promote and advance priority access on a fair and equitable basis' for Parties providing genetic resources, especially developing countries, to 'the results and benefits arising from biotechnologies based upon [those] genetic resources … on mutually agreed terms'.

IPRs are also relevant to the implementation of Article 10, which requires Parties, as far as possible and as appropriate, to integrate consideration of the conservation and sustainable use of biological resources into national decision making and to adopt measures relating to the use of biological resources to avoid or minimize effects on biological diversity (Article 10(a) and (b)). The article also requires Parties

to 'as far as possible and as appropriate … [p]rotect and encourage customary use of biological resources in accordance with traditional cultural practices that are compatible with conservation or sustainable use requirements' (Article 10(c)).

Ongoing processes

It may appear as though an international agreement such as the CBD is set in stone once countries have agreed to it but, in fact, it continues to evolve as countries undertake domestic implementation, the Parties adopt new decisions, developments transpire in other related fora and more information about biodiversity is acquired. One such major evolutionary development in the history of the

CBD is the negotiation and adoption of the Biosafety Protocol, discussed below. A current ongoing process is the negotiation of an international regime on ABS.

An international regime on ABS?

As described above, the ABS provisions in the CBD are very general, largely leaving it to Parties to develop and implement more specific rules on ABS domestically and also leaving the terms of ABS contracts to negotiation between the providers and users. In the mid-1990s, as some developing countries, such as the Philippines and Costa Rica, began to try to create national ABS systems, they found it to be an exceedingly complex exercise, requiring the collaboration of experts in science, law and business. Many developing countries lacked the capacity to bring these experts together and so were unable to implement the ABS provisions of the CBD. Furthermore, countries that were able to create domestic regimes faced challenges in their implementation. One such challenge is where access to a genetic resource was granted but the resource was removed from the country's jurisdiction. Most developing countries had little ability to track how such resources were subsequently used or to monitor whether the terms of any negotiated ABS contract were being complied with by the user of the genetic resources. Developing countries also faced a lack of capacity and experience in negotiating access contracts and were vulnerable to agreeing to terms that were not 'fair and equitable'. With much genetic diversity being shared among countries, bioprospectors seeking access might also be able to pit developing countries against each other in a race to the bottom to offer the best terms and gain at least some benefits (see Chapter 7 for a discussion of biopiracy, a related but controversial term). Developed countries, where most of the commercial users of genetic resources are located, had little interest in creating rules that would place obligations on these users to address the concerns of developing countries. They preferred ABS to be purely based on contractual terms negotiated between the providers and the users.

At the CBD, early work on the implementation of ABS provisions focused on information gathering. The Parties began to move beyond this stage at their fifth conference in 2000 when they created the Ad Hoc Open-Ended Working Group on ABS 'to develop guidelines and other approaches' on ABS to help the Parties and stakeholders. At its first meeting in 2001, the Working Group drafted the 'Bonn Guidelines on Access to Genetic Resources and the Fair and Equitable Sharing of the Benefits arising from their Utilization', which were finalized and adopted at COP-6 in 2002. The voluntary guidelines expand upon the concepts of prior informed consent and mutually agreed terms as contained in the CBD. They also provide a list of suggested elements for inclusion in material transfer agreements and list monetary and non-monetary options for benefit sharing. The Bonn Guidelines aimed, among other things, to contribute to the conservation and sustainable use of biodiversity, promote technology transfer, contribute to 'the development by Parties of mechanisms and ABS regimes that recognize the protection of TK, innovations and practices of indigenous and local communities, in accordance with domestic laws and relevant international instruments', and contribute to poverty alleviation and supporting the realization of human food security, health and cultural integrity (paragraphs 11(a), (g), (j) and (k)).

The Bonn Guidelines have proven useful for countries developing national systems to govern ABS and have been explicitly used by Australia and Kenya in the creation of their legislative frameworks. The Bonn Guidelines make little to no mention, however, of obligations on users of genetic resources or issues of enforcement. Growing frustration with the lack

of obligations on users of genetic resources led to the formation in February 2002 of the Like-Minded Megadiverse Countries (LMMC), a coalition of developing countries that represents more than 70 per cent of global biodiversity and 45 per cent of the world's population, spanning a number of geographical regions.6 The initial member countries were Brazil, China, Colombia, Costa Rica, Ecuador, India, Indonesia, Kenya, Mexico, Peru, South Africa and Venezuela. Since then, Bolivia, the Democratic Republic of the Congo, Madagascar, Malaysia and the Philippines have also joined. One of the objectives of the LMMC is the creation of binding international rules on ABS.7 The group was instrumental in obtaining two commitments on ABS in the Johannesburg Plan of Implementation from the World Summit on Sustainable Development held in September 2002. Chapter IV of the Plan addresses the protection and management of the natural resource base of economic and social development. Paragraph 44 of that chapter focuses on biodiversity, and subsection (n) encourages the implementation and further development of the Bonn Guidelines. Subsection (o) calls for action to '[n]egotiate within the framework of the Convention on Biological Diversity, bearing in mind the Bonn Guidelines, an international regime to promote and safeguard the fair and equitable sharing of benefits arising out of the utilization of genetic resources'.

At COP-7 to the CBD, in February 2004, the Parties agreed to launch the negotiations and also set the terms of reference on which the negotiations are to be based (decision VII/19, part D). There is a list of over 20 elements to be considered in the terms of reference for the negotiations including '(xiv) Disclosure of origin/source/legal provenance of genetic resources and associated TK in applications for intellectual property rights'.

The negotiations on the international regime began at the third and fourth meetings of the ABS Working Group which were held in Bangkok in 2005 and Grenada in 2006 respectively. Negotiations in Grenada were particularly acrimonious, with the African Group tabling a draft protocol on ABS that it sought to be used as the basis of negotiations and the Spanish chair of the meeting tabling a Chair's text. A number of developed countries – such as Australia, New Zealand, Japan, Canada, the EU and Switzerland – felt that the Chair's text and revised versions thereof did not adequately address their views and moved too quickly towards a legally binding regime (IISD, 2006b). A text full of square brackets marking the areas of disagreement was forwarded to COP-8 in Curitiba, Brazil, in March 2006.

In addition to government positions in the ABS negotiations, industry has also begun to take an increasingly vocal role. The International Chamber of Commerce (ICC) has been following ABS negotiations for a number of years and now has a task force on ABS that includes three major industries that use genetic resources: the agricultural sector, the industrial use of microbial resources and the pharmaceutical industry. At the Grenada meeting of the ABS Working Group, the ICC expressed the view that a 'one size fits all' approach to genetic resources would not work given the different interests and needs of different sectors (CBD, 2006b, paragraph 28). While there may be some merit to this view, taking a sector-by-sector approach to regulating genetic resources could also create a number of problems. It could result in a confusing web of rules that would be impractical to apply given that it is difficult if not impossible to predict at the time of access the different fields in which a genetic resource might be used. The sector-by-sector approach may also be a negotiating tactic to divide the discussions into many small parts, diluting the energy and capacity of developing countries to participate. (See Chapter 6 for a discussion of the IT and its ABS rules specific to plant genetic resources for food and agriculture.)

At COP-8, the Parties instructed the ABS Working Group 'to complete its work at the

earliest possible time before the tenth meeting of the Parties' in Nagoya, Japan, in 2010 (decision VIII/4, paragraph 6). What exactly is meant by the ABS Working Group 'completing its work' is left open to interpretation. The Parties named two permanent co-chairs – Tim Hodges of Canada and Fernando Casas of Colombia – to lead the ABS Working Group through the negotiations. They also agreed to forward the text from Grenada to the next meeting of the ABS Working Group, but the controversy that surrounds the text and the lack of 'ownership' vested in it by the two co-chairs suggests that it is unlikely to remain an option.

More broadly, these negotiations can be understood as the latest salvo by some developing countries in their attempts to bring balance to the world economic system. Precursors to the ABS negotiations can be found in the debates over revisions to the Paris Convention for the Protection of Industrial Property at WIPO (see Chapters 3 and 4), the negotiation of an International Code of Conduct on the Transfer of Technology at UNCTAD, and the General Assembly Resolution on the Declaration for the Establishment of a New International Economic Order (Sell, 1998). It remains to be seen whether developing countries will be more successful in extracting concessions from developed countries in the ABS negotiations than they were in these previous, largely unsuccessful undertakings.

Monitoring, enforcement and compliance: Certificates and disclosure

The tools and mechanisms to enforce the Convention – an instrument of public international law – discussed above do not necessarily apply to the enforcement of contracts, which are instruments of private international law. Developing countries with national ABS systems cannot easily monitor the use of genetic resources once they leave their jurisdiction and ensure compliance with the terms agreed to in a contract. The lack of user measures in the Bonn Guidelines, the lack of binding obligations on users of genetic resources and the unwillingness of countries that are home to commercial users of genetic resources to place obligations on these users has created a great deal of frustration among developing countries. At the CBD, this frustration has manifested itself in the push to negotiate an international regime on ABS, while in WIPO and the WTO it has led to calls for mandatory requirements for disclosure in patent applications (see Chapters 3, 4 and 7).

While these debates continue, the Parties to the CBD are considering a measure that could support disclosure requirements: an international certificates scheme. The general idea is that an access provider would also provide the user with a certificate attesting to the fact that the user gained access in accordance with the provider's rules on prior informed consent and on mutually agreed terms. Users could then use these certificates to meet any disclosure requirements in the patent system or product approval process, or in the requirements of funding agencies or publishers, and so forth. While disclosure and certificates are not the same thing – each could exist without the other – many of the debates about disclosure are echoed in the discussion of certificates (Box 5.7). Should a certificate attest to the origin, the source or the legal provenance of the genetic resource in question? Should it also cover TK? Should it be required in patent applications?

In January 2007, the CBD convened a meeting of a Group of Technical Experts on an Internationally Recognized Certificate of Origin/Source/Legal Provenance. The Group explored and elaborated possible options for the form, intent and functioning of such a certificate and analysed its practicality, feasibility, costs and benefits (CBD, 2007b, paragraph 13). The Group 'recognized that the basic role of the certificate is to provide evidence of compliance with national ABS regimes. Thus it found it practical to refer to the certificate as a certificate of compliance with national law, in accordance with the Convention' (CBD, 2007b,

paragraph 7 of annex). This change in terminology circumvents the question of origin/source/legal provenance without actually resolving which of these would be certified under a certification system. While the Group explored and elaborated options, the decisions on which options should be pursued are left for the ABS Working Group, which, at

the time of writing, has not yet considered the outcomes from the meeting of the Group of Technical Experts.

Industry has also weighed in on both the issues of disclosure and certificates. Most industry organizations are generally opposed to mandatory requirements for the disclosure of origin in patent applications. In September 2005, the US biotechnology industry formed a new lobby group – the American Bioindustry Alliance (ABIA) – under the leadership of Jacques Gorlin, one of a handful of key architects of the TRIPS Agreement. The ABIA has described its activities as 'developing industry positions and programmes to counter the unprecedented global threat to biotechnology patents at the WTO Hong Kong Ministerial Meeting … and beyond' (Garforth, 2006; see also New, 2006).8 The group is opposed to mandatory requirements for the disclosure of origin in patent applications and is active at the WTO, the CBD and WIPO in advocating this perspective. Industry views on certificates appear to be less hard-line, as illustrated by the submissions to the CBD's Group of Technical Experts (CBD, 2006a). Industry organizations have a great many questions about how a certificates system may function but may be willing to support some sort of certificates mechanism if it results in legal certainty and does not create undue administrative burdens.

The Cartagena Protocol on Biosafety9

One development in the evolution of the CBD was the creation of the Cartagena Protocol on Biosafety. The Protocol is a subsidiary instrument of the CBD and is also an evolving instrument with important links to food security and IP rights as well as biodiversity. Most fundamentally, the commercial development of genetically modified organisms (GMOs) owes much to the extension of patentability and companies' aggressive enforcement of these patent rights (see Chapter 1). What follows is an overview of the negotiations that led to the creation of the Protocol and a discussion of key provisions and ongoing processes therein.

The negotiations

The negotiation of the CBD began at a time when the potential of biotechnology was just beginning to be recognized. From the start, developing countries insisted that biotechnology be one of the key issues addressed in the Convention (McGraw, 2002, p34). This insistence was successful and led to the inclusion in the Convention of Article 19 on the 'handling of biotechnology and distribution of its benefits'. In general, the article provides that Parties to the CBD are to take measures to include countries that provide genetic resources in biotechnology research activities, to share access to the results and benefits of biotechnology, and to provide information about living modified organisms to Parties where they are to be introduced. Paragraph 3 of Article 19 obliges the Parties to the Convention to:

… consider the need for and modalities of a protocol setting out appropriate procedures, including, in particular, advance informed agreement, in the field of the safe transfer, handling and use of any living modified organism resulting from biotechnology that may have adverse effect on the conservation and sustainable use of biological diversity.

This paragraph was somewhat controversial during the negotiations as some countries wanted to make the development of a protocol mandatory (Mackenzie et al, 2003, paragraph 11).

At COP-1 to the CBD, the Parties authorized two meetings to discuss the need for a protocol. The second of these meetings, by the Ad Hoc Open-Ended Group of Experts, included support by a large majority of the delegations present for the negotiation of a biosafety protocol. At COP-2 in 1995, the Parties agreed to establish the Ad Hoc Working Group on Biosafety to elaborate a protocol on biosafety and for it to endeavour to complete its work sometime in 1998.

In the end, it took until 2000 for the negotiating countries to reach agreement on the text of a protocol. The negotiations were rocky and reached the brink of failure when there was no agreement at a February 1999 meeting in Cartagena, Colombia. In particular, the negotiating bloc of the Miami Group of countries – Canada, the US, Australia, Uruguay, Chile and Argentina, the leading agricultural exporters with the most to lose from strict regulation of GMOs – pressed for the weakest and narrowest protocol possible, nearly scuttling the negotiations at the February 1999 meeting. An extraordinary Conference of the Parties was called for January 2000 in Montreal and consensus was finally achieved. Three and a half years later, in September 2003, the Cartagena Protocol on Biosafety ('Biosafety Protocol' or 'the Protocol') entered into force.

Some of the most contentious issues during the negotiations included the scope of

the advance informed agreement procedure under the Protocol and the types of organisms it would cover; inclusion of the precautionary principle in the operational text of the Protocol (Box 5.8); the allowance for socioeconomic considerations in decision making under the Protocol; and the relationship between the Protocol and other international agreements, particularly those of the WTO. In this regard, the CBD has requested but has not yet been granted observer status in both the Sanitary and Phytosanitary and Technical Barriers to Trade Committees of the WTO.

The Protocol

The term biosafety is not defined in either the Protocol or the CBD. According to the CBD Secretariat, 'Biosafety is a term used to describe efforts to reduce and eliminate the potential risks resulting from biotechnology and its products.'10 Potential risks include the possibility that a genetically modified organism may out-compete other organisms once introduced into the environment, becoming a pest, and that genes introduced into one organism may spread to other organisms, causing environmental, economic and/or social damage.

The Protocol focuses its efforts on reducing the potential risks of LMOs resulting from modern biotechnology. The term LMO stands in contrast to the more frequently used 'genetically modified organism' and it is carefully defined in the Protocol as 'any living organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology'. The Protocol is a subsidiary instrument of the CBD and so only Parties to the Convention may become Parties to the Protocol (Box 5.9). There are 143 Parties to the Protocol as of late 2007.

The Protocol is a complex and intricate instrument and our focus is on two of its decision-making procedures for LMOs. The scope and terms of these procedures are intimately linked with the economics that were at stake during the negotiations.

The Protocol divides LMOs into several categories. The two main groups of concern are LMOs that are intended for intentional introduction into the environment of an importing Party and LMOs for use as food, feed or for processing (LMOs-FFP):

[LMOs-FFP include] such widely traded commodities as genetically modified corn, soy, wheat, canola and tomatoes. Those opposed to including commodities in the Protocol had argued that commodities, since they are not intended for introduction into the environment, pose no threat to biodiversity and should not be the subject of a protocol to the CBD. LMOs intended for introduction into the environment, on the other hand – such as seeds and micro-organisms – can mutate, migrate and multiply, and therefore may pose unexpected threats to native species. Others argued that it was impossible to ensure that LMO-FFPs would not be introduced to the environment, whatever the intent. (Cosbey and Burgiel, 2000, p4).

By the time the negotiators met in Cartagena in 1999, they had agreed that LMOs-FFP would be included in the scope of the Protocol. The remaining question was whether they would be subject to the Protocol's advance informed agreement (AIA) procedure.

The Miami Group's aim in Cartagena was to keep LMOs-FFP outside the AIA procedure, whereas the Like-Minded Group (see Box 5.8) was similarly insistent that LMOs-FFP should be subject to it or a similarly robust procedure (SCBD, no date, p42). The final text represents a compromise but was essentially a 'win' for the Miami Group as the Protocol creates a separate procedure for LMOs-FFP, a procedure that is less onerous for exporters than the AIA procedure.

The distinction between LMOs that are for intentional introduction into the environment and those that are not is somewhat of a legal fiction as LMOs in the latter category can easily wind up being released into the environment, regardless of intention (Box 5.10) The introduction of genetically modified commodities into an environment where they are not intended to be introduced raises a number of IP concerns. If a company has a patent on the gene that is spreading through the countryside, will the company be able to sue farmers for patent infringement and stop them from growing any crop that contains the gene? This scenario is not at all far-fetched given the case of Monsanto v. Schmeiser (discussed below) and Monsanto's actions over Argentinean exports of Roundup Ready soya (GRAIN, 2006a; see also Chapter 8, Box 8.8). The impacts that this sort of action could have on the livelihoods of subsistence farmers and the biodiversity they cultivate are potentially catastrophic. It can also mean that the introduction and spread of LMOs in the environment becomes a fait accomplish without the organism going through the necessary regulatory process.

LMOs that are intended for intentional introduction into the environment of an importing Party are subject to the AIA procedure (Articles 7–10). The aim of this procedure is to ensure that importing countries have the opportunity to assess 'the possible adverse effects of LMOs on the conservation and sustainable use of biological diversity, taking also into account risks to human health' (Article 15(1)). The procedure requires the Party that intends to export LMOs to notify, or to require the exporter to notify, the Party that is destined to be the importer (Article 8(1)). The notification must include, as a minimum, the information in Annex I to the Protocol, which includes descriptions of the organism in question, intended use of the organism and the regulatory status of the LMO in the country of export. The importing Party is then required to acknowledge receipt of the notification, including '[w]hether to proceed according to the domestic regulatory framework of the Party of import or according to the procedure specified in Article 10' (Article 9(2)(c)). Article 10, in turn, sets out a decision-making procedure that Parties can (but are not obliged to) use to determine whether to approve or prohibit the import, or request additional information. The procedure includes a risk assessment and allows the Party of import to use precaution to avoid or minimize the potential adverse effects of the LMO where there is scientific uncertainty. According to the information available on the BCH, the AIA procedure has been little used.11

The procedure for LMOs-FFP is contained in Article 11 of the Protocol. The article requires a Party that makes a decision concerning domestic use of an LMO-FFP that may be subject to transboundary movement to notify the other Parties of the decision via the Biosafety Clearing-House. The procedure still allows countries to make their own decisions about the import of LMOs-FFP and these decisions can be based on precaution.

Key issues in the Protocol

As with the Convention, the final agreed text of the Protocol is not a static instrument. On two issues in particular (labelling plus liability and redress), negotiators were unable to reach agreement on substantive provisions and so included enabling clauses in the Protocol that called for further negotiation on these once the Protocol entered into force. These issues can be seen as part of the balancing requirements and risk sharing for those who benefit from IP-protected products and processes deriving from modern biotechnologies which they promote.

Labelling of shipments

Article 18 of the Protocol concerns 'handling, transport, packaging and identification'. Paragraph 2 of the article sets out the documentation requirements that must accompany shipments of different categories of LMOs. Most controversial is sub-paragraph (a), which, with its chapeau, reads:

Each Party shall take measures to require that documentation accompanying … LMOs that are intended for direct use as food or feed, or for processing, clearly identifies that they 'may contain' LMOs and are not intended for intentional introduction into the environment, as well as a contact point for further information. The Conference of the Parties serving as the meeting of the Parties to this Protocol shall take a decision on the detailed requirements for this purpose, including specification of their identity and any unique identification, no later than two years after the date of entry into force of this Protocol.

This sub-paragraph was the last issue to be agreed by the Extraordinary Conference of the Parties in Montreal in 2000 (SCBD, no date,

p60). The controversy surrounds the meaning of the words 'may contain' and the extent to which they will enable countries to label LMOs or GMOs that are sold to consumers.

In the event the Parties were unable to reach agreement about Article 18.2(a) during the second meeting of the Parties to the Protocol held in Montreal in May–June 2005, due in large part to New Zealand and Brazil. This increased the pressure on the Parties at MOP-3 in Curitiba, Brazil, in 2006 to reach agreement, as another failure might seriously compromise the Protocol.

Long negotiating sessions among a few key players, including Ethiopia, Malaysia, Brazil, New Zealand, Mexico and the EU, resulted in

decision BS-III/10. Paragraph 4 of the decision sets the 'detailed requirements' requested by Article 18.2(a). It requires Parties to the Protocol to ensure that documentation accompanying LMOs-FFP states, in cases where the identity of the LMOs is known, that the shipment contains such LMOs, and, in cases where the identity of the LMOs is not known, that the shipment may contain such LMOs. In paragraph 6 of the decision, the Parties acknowledge that the expression 'may contain' does not require a listing of LMOs other than those that constitute the shipment. Overall, the decision tries to balance the concerns and obligations of countries that are likely to be importing bulk shipments of commodities that could contain LMOs with the concerns and obligations of those likely to be exporting such shipments, some of whom are not Parties to the Protocol and so are not bound to comply by its provisions. It seems ironic, then, that New Zealand, which has one of the strictest domestic systems for the regulation of GMOs, was arguing for extremely weak rules at the international level. This illustrates the complexity of international processes and how a country's position may be influenced by a number of different interests, in this case New Zealand's high economic dependence on agricultural exports and its relationship with its trading partners, particularly the US.

Despite the text in decision BS-III/10, all is not what it seems, and the decision largely delays the issue yet again. It requires the Parties at their fifth meeting (in 2010) to review and assess experience gained with the implementation of paragraph 4, with a view to considering a decision at their sixth meeting to ensure that documentation accompanying LMOs-FFP covered by paragraph 4 clearly states that the shipment contains such LMOs (paragraph 7). So, while a decision has been adopted that ostensibly satisfies the demands of Article 18.2(a), the issue is by no means resolved and will continue to be debated by the Parties.

Liability and redress

According to the CBD Secretariat:

The term 'liability' is normally associated with the obligation under the applicable law to provide for compensation for damage resulting from an action for which that person is deemed responsible. Liability and redress in the context of the Protocol concerns the question of what would happen if the transboundary movement of living modified organisms … has caused damage.12

The Like-Minded Group insisted on the inclusion in the Protocol of provisions on liability and redress:

The motto 'no liability, no Protocol', displayed on blue-green badges, was adopted during the negotiations by delegates arguing for the inclusion in the protocol of some provision for liability and redress. It was intended to reinforce the message that if this subject were to be left out, the prospects for successfully finalizing a protocol would be minimal. Some of those less well disposed towards the ultimate success of the protocol negotiations also muttered the phrase to themselves, in hope rather than defiance, and at times the words looked like a forlorn prophecy rather than a clarion call to address this knotty issue. (Cook, 2002, p372)

As it became clear that negotiating substantive provisions on liability and redress would be time-consuming and delay the adoption of the Protocol as a whole, an enabling provision was included in the Protocol mandating MOP-1 to 'adopt a process with respect to the appropriate elaboration of international rules and procedures in the field of liability and redress for damage resulting from transboundary movements of living modified organisms'

(Article 27). At MOP-1, the Parties agreed to establish an Ad Hoc Open-Ended Working Group of Legal and Technical Experts on Liability and Redress. This enabling provision is somewhat analogous to Article 27.3(b) of TRIPS and its requirement for its own review four years after the entry into force of the WTO Agreement (see Chapter 3). Both provisions delay consideration of complicated issues and allow all sides in the negotiations to claim to have achieved something. These perceived achievements might well be contradictory, however, meaning that the US may claim that the Article 27.3(b) review provides for the elimination of any restrictions on patentability while developing countries might claim that it provides for the elimination of any requirements for the patentability of living organisms. Under the Protocol, developing countries can claim that Article 27 requires the negotiation of legally binding rules on liability and redress, while the main exporters of LMOs can claim that no such rules are mandated, feasible or desirable.

The Protocol's Working Group on Liability and Redress has a mandate to meet five times over four years. However, it is not specifically mandated to negotiate rules on liability and redress; rather it is, among other things, to elaborate options for elements of the rules and procedures referred to in Article 27 of the Protocol (decision BS-I/8, Annex).

To date, the Working Group has engaged in an exercise of compiling approaches, options and issues on rules and procedures for liability and redress. However, the difficult compromises have yet to be made and negotiations will truly take place during the final meetings of the Working Group and, in all likelihood, at MOP-4. It is even conceivable that the Parties will need to renew the mandate of the Working Group if it is unable to finalize its deliberations.

Perhaps the most fundamental point to be decided is the nature of the rules and procedures being discussed. The third meeting of the Working Group ended with an impassioned intervention from Malaysia, calling for a legally binding instrument. Anything less, it was stated, would be a betrayal of the trust of the developing countries who agreed to the compromise of the enabling provision in Article 27. Norway also spoke in favour of a legally binding regime in order to ensure consistent and predictable rules across jurisdictions. This could signal the emergence of an important North–South coalition. At the same time, however, while Principle 13 of the Rio Declaration urges the development of international liability rules, past experience with negotiating binding rules on liability has been less than positive. A number of instruments have taken many years to negotiate and to enter into force or have failed to enter into force altogether.13

Other key issues in the liability and redress negotiations include:

• The definition of damage. Will it be restricted to damage to biodiversity or the conservation and sustainable use of biodiversity (and if so, what does this mean)? Or will it encompass more traditional grounds, such as damage to the person or property, economic damage, or damage to the environment?

• The functional scope of the rules and procedures. Will the rules and procedures apply to damage resulting from the intentional transboundary movement of LMOs, unintentional transboundary movements, and/or illegal transboundary movements? Will they apply to damage within a Party, within a non-Party and/or beyond national jurisdiction?

• The standard of liability. Will liability be strict or will it require some proof of fault? It might be noted that patent law is a strict liability regime – simple infringement of a patent is sufficient to give rise to liability, with no fault being required (see Chapter 1, Box 1.6, and the discussion of Monsanto v. Schmeiser, below).

• Channelling of liability. Who can potentially be held liable? The developer,

the producer, the notifier, the exporter, the importer, the carrier, the supplier?

Balancing IPRs with responsibility for damage from LMOs

While the issue has not been considered in any detail during the deliberations of the Working Group, there is a connection to be made between liability for damage caused by LMOs and IPRs over these same organisms. More specifically, it is not the IPRs per se but the control they give to their owner that ties them to the question of liability (de Beer, 2007). The juxtaposition of two Canadian cases illustrates the point quite clearly.

In the first case, the Supreme Court of Canada's decision in Monsanto v. Schmeiser granted Monsanto expansive patent protection over the genetically modified gene and cell in its Roundup Ready canola. The Court's interpretation of the patent was expansive because while the patent only claimed the genetically modified gene and the cells containing the gene, the effect of the Court's decision was to give Monsanto patent protection over the entire plant. This was in spite of the fact that higher life forms such as plants are not patentable in Canada.14 A further outcome of Schmeiser was that it placed all of the burdens on the farmer to avoid infringement of the patent. Canadian patent law, like patent laws in many other countries, does not require a person to intend to infringe or even knowingly infringe a patent in order to be found liable. With Monsanto's patented genes spreading by natural means throughout the Canadian prairies, this rule places the onus on the farmer to monitor his fields for volunteer GM canola plants or the spread of the introduced genes. If and when the patented genes appear, the farmer must call the company to come and remove the plants. In Monsanto's case, at least, in order for the company to remove the plants, the farmer is required to sign a waiver that releases the company from any lawsuits 'associated with the products and forbids the grower from disclosing the terms of the settlement' (Pratt, 2005).15 Wilful blindness is not an option – if the farmer does not monitor his fields or call the company after having detected the genes, he faces the threat of patent infringement litigation. And if sued, it is the farmer who must rebut the presumption of use through an innocent bystander defence that the Supreme Court has said exists but has not defined (Garforth and Ainslie, 2006, pp470–471).

In the second case, Hoffman v. Monsanto, a group of organic farmers from Saskatchewan are attempting to launch a class action suit against Monsanto and Bayer for damages caused by the spread of the companies' genetically modified varieties of canola. Among other things, the farmers have grounded some of their allegations in the fact that Monsanto, in particular, continues to exercise control over the offending genes and cells through its IPRs and active assertion thereof. In essence, through their lawsuit the farmers are attempting to place some of the burdens for the consequences of GM plants back on the companies that developed them and profit from them.

To date, however, the farmers have been unsuccessful. The courts have refused to certify their class action, finding, among other things, that their causes of action would fail at trial. The combined effect of the Schmeiser and Hoffman decisions is somewhat paradoxical: 'Monsanto can exert unprecedented levels of control over things it could not patent, whilst simultaneously being able to deny that it has any control over the same product in the context of the common law or statute. This is an unacceptable incongruity' (Phillipson, 2005, p372). Rather than balancing the IPRs of the companies with a corresponding responsibility, the courts have added to the already heavy burden placed on Canadian farmers in the wake of Schmeiser. In addition to the burden of avoiding patent infringement, the farmer must now also bear the burden of damage (see also Box 1.6).

How has it come to pass that biotechnology companies can enjoy all the benefits of expansive patent protection without any obligations? Through the language of property: 'Patentees are quick to invoke the power of property rhetoric to expand and protect their rights, but when it comes to the liabilities ordinarily associated with ownership, the tune suddenly changes' (de Beer, 2007). Not all countries have the same history of case law as does Canada, however, so this disequilibrium between rights and responsibilities should not be regarded as the norm. It remains to be seen if and how these considerations might be incorporated into the activities of the Biosafety Protocol's Working Group on Liability and Redress.

Compliance

The Protocol addresses compliance (Article 34) and the Parties have set up a Compliance Committee (see Box 5.9). The Committee has 15 members, who are selected on the basis of regional representation and who serve in a personal capacity. The Committee is mandated to meet twice a year and can choose whether its meetings are open to observers. Its functions include identifying the specific circumstances and possible causes of individual cases of non-compliance referred to it; considering information submitted to it regarding compliance and non-compliance; providing advice and/or assistance to a Party 'on matters relating to compliance with a view to assisting it to comply with its obligations under the Protocol'; reviewing general issues of compliance; and taking measures or making recommendations to the MOP. While the Protocol has a more specific compliance mechanism than does the Convention, it still largely relies on the same strategies of transparency and positive incentives to try to effect compliance, as shown by the measures it and the MOP can take. The measures include providing advice, assistance and/or various capacity-building measures to the Party concerned and publishing cases of non-compliance in the Biosafety Clearing-House.16

To date, the Compliance Committee has not received any submissions about the compliance or non-compliance of a specific Party. It is even possible that the Committee will never receive a submission as the dictates of diplomacy would suggest that countries may prefer to seek more private solutions to any problems that arise between or among them. In this regard, there is no obligation on Parties requiring them to make submissions on instances of non-compliance if and when they are aware of them. Furthermore, with certain key exporters of LMOs (such as the US, Canada and Argentina) not being Parties to the Protocol, their actions are beyond the mandate of the Committee. In its meetings to date, the Committee has developed its rules of procedure and adopted a work plan, developed recommendations for consideration by the MOP, reviewed general issues of compliance, and reviewed information on measures concerning cases of repeated non-compliance.17

Conclusion

The Biosafety Protocol has already reached some key milestones. It has entered into force and the Parties have agreed to a decision on the detailed identification requirements for implementing Article 18.2(a) on documentation to accompany LMOs. It is still relatively early days for the Protocol, however, and key issues such as the rules and procedures on liability and redress remain to be resolved. The connection between IPRs and biosafety may be less obvious but is certainly present. Biosafety regulation is intended to address concerns about gene flow, but as introduced genes continue to spread through the environments where they have been released and also to spread from country to country, the IPRs over these genes give the proprietor companies increasing control over who can grow what, where and how. This has potentially serious consequences for farmers, food security and biodiversity, but these consequences have, to date, largely remained outside the deliberations under the Protocol.

Neither the Convention nor the Protocol are static instruments. Both are evolving. Furthermore, the way they evolve is not necessarily logical or rational but is highly dependent on politics. It is difficult to capture in writing the importance of the personalities involved in the negotiations. Meetings led by competent chairs will generally produce better results; when negotiators get along with one another – whether or not their positions on an issue are similar – they will more easily reach a compromise. Personality conflicts and power struggles over process can spell disaster. These are just some of the intangibles that feed into the eventual outcomes of negotiations.

The Convention on Biological Diversity and the Cartagena Protocol on Biosafety are pieces in a larger puzzle of international rules and negotiations on these issues. They should not and cannot be fully understood in isolation and so must be interpreted in light of the other chapters in this book. To this end, the next chapter turns to one of the newest agreements and its role in the IPRs, biodiversity and food security nexus.

Resources

The website of the Secretariat to the Convention can be found at www.cbd.int.

IUCN (The World Conservation Union) has produced two valuable guides, one to the Convention (Glowka et al, 1994) and the other to the Biosafety Protocol (Mackenzie et al, 2003).

6
Giving Priority to the Commons: The International Treaty on Plant Genetic Resources for Food and Agriculture

Michael Halewood and Kent Nnadozie

Intensive human activity over thousands of years created today's agricultural biodiversity. Attempts to create market-based incentives for its conservation and innovative uses, through the application of intellectual property (IP) and CBD-inspired access and benefit sharing (ABS) laws have not benefited large numbers of smallholder farmers, often living in marginal agricultural environments, who are the most active present-day users of agricultural biodiversity. Evidence is also growing that restricted access and use of plant genetic resources for food and agriculture (PGRFA) as a result of the application of these same laws (or political uncertainties surrounding them) can have a deleterious impact on scientific research and breeding. The International Treaty on Plant Genetic Resources for Food and Agriculture provides a general framework for conservation and sustainable use of PGRFA. Most dramatically, it also establishes a plant genetic resources commons to lower transaction costs for conservation, research, breeding and training, and to redistribute back to the commons some of the financial benefits derived from the commercial exploitation of those resources (under certain circumstances). The Treaty is unlike laws analysed in previous chapters because it concentrates on defining and maintaining a commons, instead of means by which to fence portions of it off.

Introduction

The International Treaty on Plant Genetic Resources for Food and Agriculture (the Treaty) represents a spirited reaction to the rising tide of measures that extend private or sovereign control over genetic resources, which is inappropriate for food and agriculture. It recognizes that ABS for agricultural biodiversity must be treated differently from the way it is generally treated under the Convention on Biological Diversity (CBD). The Treaty creates an international genetic resources commons – the 'multilateral system of access and benefit sharing' – within which members, in exercise of their sovereignty, provide free (or almost free)

access to each other's plant genetic resources for research, breeding, conservation and training. It does not matter how many accessions of different species members bring with them into the club; as long as they agree to share what they have, they can get access to all the other members' materials for their own use. Access to materials within the commons comes largely without strings attached, and the strings that do exist are there to maintain the spirit of the commons. For example, recipients cannot take out intellectual property rights (IPRs) that prohibit others receiving them in the same form from the multilateral system. And if recipients choose to prohibit others from using, for their own research and breeding, any product they develop using materials they got from the commons, they must share a percentage of their sales of that product with the international community through a conservation fund.

The commons does not in any way restrict the sovereignty of countries over their resources; quite the opposite, in fact. The preamble to the Treaty explicitly recognizes that 'in the exercise of their sovereign rights over their plant genetic resources for food and agriculture, states may mutually benefit from the creation of an effective multilateral system for facilitated access to a negotiated selection of these resources and for the fair and equitable sharing of the benefits arising from their use'. Parties first exercised their sovereignty by participating in the negotiations of the Treaty and the creation of the commons, and then by choosing to become a member of it. Furthermore, they can, of course, withdraw from membership in the Treaty if they wish.

The commons created by the Treaty is not yet fully global, but it appears to be well on its way. So far, 113 countries have ratified the Treaty, and a number of others are on the verge of doing so, with each new country adding to the overall number of accessions within the commons. In addition, the eleven International Agricultural Research Centres of the Consultative Group on International Agricultural Research (the CGIAR Centres) holding ex-situ collections of plant genetic resources for food and agriculture (PGRFA), the Centro Agronómico Tropical de Investigación y Enseñanza (CATIE) and two of the four organizations hosting collections as part of the International Coconut Genetic Resources Network have placed the collections they host under the framework of the Treaty, to be distributed according to the same rules. At present, it is impossible to say how many accessions of PGRFA are in the Treaty's commons (but it is in the millions), or how many times samples will actually be accessed or provided each year (but it will be in the hundreds of thousands).

Of course, the Treaty is not perfect. It is the product of seven and a half years of often highly polarized negotiations, and a number of compromises were necessary – with some contentious issues left hanging – for the countries involved to be able to agree on the final text in November 2001. Considerable progress has been made since then, but some challenges remain to be addressed before the Treaty, and the commons it creates, can be fully operational.

In this chapter, we briefly review why the Treaty was needed, focusing on the 'international' nature and uses of plant genetic resources for food and agriculture. Then we describe the mechanics of the Treaty, with particular emphasis on the multilateral system of ABS and its intersection with IP laws. We highlight the most innovative aspects of the Treaty, as well as challenges associated with its implementation. We also include accounts of how some of its elements evolved during the negotiations. Finally, we consider the potential implications of the Treaty – both its achievements and its limitations – for ongoing policymaking processes affecting how genetic resources for food and agriculture are conserved (or lost) and used (or ignored).

Why Create a PGRFA Commons?

The history of the development and use of PGRFA has been characterized by relatively rapid movements of domesticated materials – often in the form of a combination of domesticated crops and animals (and associated pests) – across and among continents, with ultimately a relatively small number of species representing a very high percentage of the daily diets of people around the world (Diamond, 2005). A FAO study on national and regional interdependence revealed that 'four crops – rice, wheat, sugar (beet and cane) and maize account for over 60 per cent of human calorie intake from plants' (Palacios, 1998). All countries are interdependent in their reliance on PGRFA. No region or country is self-sufficient. In examining the contribution of major food crops to peoples' daily caloric consumption around the world, the study concluded that all regions were dependent on PGRFA from other regions to a high degree, with the degree of dependence for most regions being over 50 per cent. No country in the study was ranked as even close to self-sufficient. This interdependency is graphically illustrated in a number of studies of the international flows of PGRFA and in the pedigrees of crop varieties of major food crops (SGRP, 2006a). For example, the wheat cultivar Sonalika, which was planted on over 6 million hectares in developing countries in 1990, has a pedigree drawing on materials acquired from 15 countries. Sonalika is far from being unique. Major spring bread wheats (planted on more than 0.25 million hectares in the developing world in 1997) on average had 50 farmers' varieties parental combinations (Cassaday et al, 2001). Table 6.1 demonstrates the international nature of the pedigrees of a number of rice varieties.

PGRFA differ from other plant genetic resources (and genetic resources of all wild flora and fauna) because human intervention has played a critical role in the domestication of crops and in the human, gene and environmental interactions that have led, over thousands of years, to the genetic diversity within and across

Table 6.1 Summary of international flows of rice ancestors in selected countries

species that currently exists. In the absence of active and continuous human management, most crop varieties would cease to exist (Darwin, 1859). Over the millennia, farmers have domesticated wild plants and, through a process of selection and breeding, made them suitable for agriculture. This they have done by breeding out the natural traits, such as shattering of seed-heads prior to maturity or seed dormancy, that allow those plants to survive in the wild. They have also bred in new traits, such as higher yields and drought or disease resistance. Any individual plant variety is thus the product of the breeding work of thousands of farmers over many generations.

Plant genetic resources are the foundation for all agriculture – providing the basis for developing new and improved varieties, and thus essential for achieving food security. Within the weedy and wild relatives, among the farmers' varieties developed on the farm or stored carefully in a seed bank, lie the genetic traits of resistance to plant viruses, diseases and even insects. It is by screening thousands of varieties that critical traits are found that can save an entire crop and perhaps stave off a national or regional hunger crisis. The value of this variety is difficult to estimate, though the benefits from wheat breeding for spring bread wheat alone in the developing world were approximately US$2.5 billion annually by the late 1980s (Byerlee and Traxler, 1995). PGRFA are clearly important as an immediate resource. They provide particular characteristics such as pest resistance, drought tolerance, plant architecture, taste, nutrition and colour essential for market success and adaptation in agricultural systems. PGRFA are also important as insurance against unknown future needs. Maintaining plant genetic diversity both within seed banks and in farmers' fields in the centres of origin is essential for responding to future challenges such as developing resistance to new diseases. As a result of their interdependence on PGRFA, countries must constantly access and use (for breeding, other forms of research and direct

use) PGRFA from other countries. Analysis of acquisitions and distributions of PGRFA by the gene banks hosted by the CGIAR Centres illustrates this phenomenon (Box 6.1). Another study showed that 88 per cent of the unique accessions of seven crops accessed by Uganda and Kenya between 1980 and 2004 were originally collected in other countries and continents (Halewood et al, 2005).

Scientific hurdles and complex transaction costs

The creation of this commons for PGRFA avoids the problem inherent in the approach to ABS in the CBD, which is predicated upon being able to identify the 'origin' of material as a 'trigger' for benefit sharing. The CBD (Article 2) defines the 'country of origin of genetic resources' as 'the country which possesses those genetic resources in in-situ conditions.' In turn, the CBD defines 'in-situ conditions' as those 'conditions where genetic resources exist within ecosystems and natural habitats and, in the case of domesticated or cultivated species, in the surroundings where they have developed their distinctive properties'. Pursuant to this definition, the CBD requires more than simply identifying the country of origin of a crop – it requires the identification of the country of origin of the distinctive properties of the crop. Much of the literature addressing the international flows and pedigrees of PGRFA suggests, directly or indirectly, that it is difficult or impossible to determine the country of origin of crop varieties, and even more so their distinctive traits, given the long histories of human intervention and cooperation involved in their development (SGRP, 2006a). The Treaty avoids this problem by creating a multilateral system for ABS that builds upon and complements the international historical development of PGRFA. The two specifically listed criteria in the Treaty for identification/inclusion of crops and forages in the multilateral system of ABS are interdependence and importance to food security.

From Recognition of Threats, to the International Undertaking

The interdependence among nations for PGRFA and the common challenge of genetic erosion served as catalysts for the creation of an internationally cooperative system for germplasm collection and conservation through the Plant Genetic Resources and Crop Ecology Unit, established in the FAO in 1968. In 1972, the CGIAR followed recommendations of the UN Conference on the Human Environment and created the International Board for Plant Genetic Resources (IBPGR). The IBPGR was integrated into the CGIAR and had its own budget, and its secretariat was funded by the FAO's Plant Genetic Resources Unit; it was located in the FAO in Rome. Its responsibility was to coordinate (and undertake) collection, conservation, evaluation, documentation and use of germplasm (Esquinas-Alcázar and Hilmi, 2007).

In 1983, as discussed in the introduction to Chapter 5, the 22nd FAO Conference approved, without consensus, and with eight countries registering objections, the International Undertaking on Plant Genetic Resources for Food and Agriculture (IU). It also created, at the same time, the Commission on Genetic Resources for Food and Agriculture (CGRFA) to oversee the IU. The IU was the first comprehensive international agreement dealing with PGRFA. It sought to promote international harmony in matters regarding PGRFA and explicitly declared 'the universally accepted principle that plant genetic resources are a heritage of mankind and consequently

should be available without restriction'.

The basis of the reservation on the IU expressed by the eight countries was that it did not recognize plant breeders' rights (PBRs), which were enshrined at that time in the UPOV Conventions of 1961 and 1978 (see Chapter 2). In 1989, Resolution 4/89 – through which all countries finally recognized the primacy of those rights – was adopted by the FAO Conference to appease the 'hold-out' countries and to bring them unto the IU by recognizing their right to 'impose only such minimum restrictions on the free exchange of materials covered by [the IU] as are necessary for [them] to comply with [their] international obligations' under the UPOV Conventions. Another resolution (5/89), with its vaguely formulated recognition of the contribution and rights of farmers, was designed to appease those that had compromised by recognizing plant breeders' rights. The influence of the ongoing negotiations of the CBD was later felt in 1991 with the adoption of Resolution 3/91 by the FAO Conference, which recognized that 'the concept of mankind's heritage, as applied in the International Undertaking on Plant Genetic Resources, is subject to the sovereignty of the states over their plant genetic resources'.

From IU to Treaty

As discussed in Chapter 5, while adopting the text of the CBD as an appendix to the Nairobi Final Act, governments also resolved that there were outstanding issues on 'the interrelationship between the Convention on Biological Diversity and the promotion of sustainable agriculture'. In 1993, the FAO Conference requested the FAO to provide a forum in the Commission on Genetic Resources for Food and Agriculture for negotiation among governments for:

• the adaptation of the IU, in harmony with the CBD;

• consideration of the issue of access on mutually agreed terms to plant genetic resources, including ex-situ collections not addressed by the CBD; and

• the issue of the realization of farmers' rights.

Also in November 1993, the FAO Conference adopted the International Code of Conduct for Plant Germplasm Collecting and Transfer (Box 6.2).

Tough negotiations

The negotiations of the Treaty text took six and a half arduous years, from the First Extraordinary Session of the Commission, in November 1994, to its Sixth Extraordinary Session, in June 2001. The negotiations were long and tough, with highly polarized debates between developed and developing countries. Some of the most contentious issues concerned the scope of crops and forages to be included within the multilateral system of ABS (MLS), the actual terms of benefit sharing, and IPRs (Box 6.3). The scope of materials to be included in the MLS was one of the most contentious negotiating issues and it shifted considerably over the course of the negotiations of the Treaty. In the end, negotiators agreed upon a list of 35 crops and 29 forage genera to be included in the MLS. These are popularly referred to as 'Annex I' crops or materials since they are included in Annex I to the Treaty (see Appendix 3, page 249, for a brief history of the list and the crops included).

As is the case in most, if not all, international negotiations, developed countries enjoyed substantially more financial and human resource support during the negotiations of the Treaty and, later, the Standard Material Transfer Agreement (SMTA). Developed country

delegates therefore came to Treaty negotiating sessions with more thoroughly annotated briefing books, and as part of substantially larger delegations that included experts from a diversity of departments to provide support on technical issues. During the negotiations all regional groups of countries are allowed the opportunity to meet together for a day or two immediately prior to the negotiating sessions, and the stipend from the FAO covers these extra days' expenses. However, regional meetings in preparation for the negotiating sessions in Rome were very important, given that delegations were meant to speak through regional representatives. Not surprisingly, the Europeans (though the coordination mechanism of the European Union) and North America were able to arrange regional meetings and/or communications between a number of the negotiating sessions. The African Group, at the other extreme, did not enjoy the benefit of any dedicated intersessional regional meetings in Africa until sometime after the Treaty text was actually adopted, and negotiations on the SMTA were underway. These intersessional meetings within regions can make a big difference to groups' effectiveness.1

Apart from government negotiators, the private sector (biotechnology, seed and breeding companies), the CGIAR Centres and civil society organizations all played roles in the negotiation of the Treaty. The CGIAR Centres followed the negotiations closely, providing technical inputs on a number of subjects, including crop taxonomies, international flows of PGRFA and global information systems.

The private sector also participated actively in the international negotiations of the Treaty and, subsequently, the SMTA, mostly through the International Seed Federation (ISF), which represents, directly or indirectly, more than 10,000 seed companies around the world. The

ISF was a keen and active observer throughout the negotiations of the Treaty and related processes, frequently publishing their positions – usually very clearly stated – on the ISF website. Companies, of course, were also consulted by their representative governments, and their influence was, naturally enough, pretty important for some developed countries' delegations and their positions. Some delegations included representatives from the private sector of the countries concerned.

In contrast to both the CGIAR and the private sector, civil society organizations' participation in the Treaty process – while very active at first – declined precipitously over the years. During the First Session of the Governing Body in 2006 (see below), civil society organizations themselves made impassioned pleas for more civil society organizations – farmers' organizations in particular – to be involved in future meetings of the Governing Body, pleas that were supported by most delegations. The Governing Body requested the Secretary to facilitate the participation of civil society organizations in the work of the Treaty, especially in the implementation of its Article 6 on the sustainable use of plant genetic resources.

The text of the Treaty was finally adopted in November 2001 by the FAO Conference (Table 6.2). The Treaty entered into force in June 2004, 90 days after the deposit of the 40th instrument of ratification. As of June 2007, 113 Parties had ratified (approved or acceded to) the Treaty.2

However, the entry into force of the Treaty was not enough, in itself, for the genetic resources commons – the MLS – to be operational. In addition, the Parties had to negotiate further to develop the Standard Material Transfer Agreement (SMTA) to be used for all transfers of materials under the multilateral system. The S