Access to Plant Genetic Resources and the Equitable Sharing of Benefits: a contribution to the debate on systems for the exchange of germplasm

The International Plant Genetic Resources Institute (IPGRI) is an autonomous international scientific organization operating under the aegis of the Consultative Group on International Agricultural Research (CGIAR). The international status of IPGRI is conferred under an Establishment Agreement which, by December 1995, had been signed by the Governments of Australia, Belgium, Benin, Bolivia, Burkina Faso, Cameroon, China, Chile, Congo, Costa Rica, Côte d'Ivoire, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Greece, Guinea, Hungary, India, Iran, Israel, Italy, Jordan, Kenya, Mauritania, Morocco, Pakistan, Panama, Peru, Poland, Portugal, Romania, Russia, Senegal, Slovak Republic, Sudan, Switzerland, Syria, Tunisia, Turkey, Ukraine and Uganda. IPGRI's mandate is to advance the conservation and use of plant genetic resources for the benefit of present and future generations. IPGRI works in partnership with other organizations, undertaking research, training and the provision of scientific and technical advice and information, and has a particularly strong programme link with the Food and Agriculture Organization of the United Nations. Financial support for the agreed research agenda of IPGRI is provided by the Governments of Australia, Austria, Belgium, Canada, China, Denmark, France, Germany, India, Italy, Japan, the Republic of Korea, Mexico, the Netherlands, Norway, Spain, Sweden, Switzerland, the UK and the USA, and by the Asian Development Bank, IDRC, UNDP and the World Bank.

The geographical designations employed and the presentation of material in this publication do not imply the expression of any opinion whatsoever on the part of IPGRI or the CGIAR concerning the legal status of any country, territory, city or area or its authorities, or concerning the delimitation of its frontiers or boundaries. Similarly, the views expressed are those of the authors and do not necessarily reflect the views of these participating organizations.

© International Plant Genetic Resources Institute, 1996

Table of Contents

Summary

Organization of the Paper

Part I. Introduction, Context and Options

• Chapter I. Introduction
• Chapter II. System Options

Part II. A Multilateral System for Exchange (MUSE)

• Chapter III. Options for Implementing a Multilateral System for Exchange (MUSE)
• Chapter IV. Scope
• Chapter V. Conclusions and Next Steps

Annex I. Statement to the Sixth Session of the Commission on Plant Genetic Resources by Dr. Geoffrey Hawtin, Director General of the International Plant Genetic Resources Institute (IPGRI)

Annex II. Terms of Reference for and Composition of the IPGRI Multilateral Study Team and Task Force

Annex III. Informal Consultation Process Undertaken by the Study Team

Annex IV. Provisions for Bilateral Benefit-Sharing within MUSE

Summary

1. The 6th session of the FAO Commission on Plant Genetic Resources requested that IPGRI study the feasibility of possible systems for the exchange of plant genetic resources for food and agriculture (PGRFA) and the equitable sharing of benefits. The following report is the result of that study. It seeks to provide the Commission with a set of options and their implications and thus to inform international negotiations concerning the revision of the International Undertaking on Plant Genetic Resources. As part of the study process a wide series of consultations was held with major stakeholder groups.
2. A fundamental justification for conserving and characterizing PGRFA is their potential for use in the development of improved crop varieties. These improved varieties are necessary to meet the food needs of a growing population and the demands of changing agro-ecological and social conditions. Plant breeding for sustainable agriculture is dependent on the existing diversity of PGRFA. Yet this diversity is currently underused and furthermore, is threatened by genetic erosion.
3. Important food crops are usually widely distributed and may be major staples in regions far from their origin. The dispersal and exchange of crops have gone on since the early spread of agriculture. The reliance of countries on introduced crops means that no country is self-sufficient in plant genetic resources. Even though many nations harbour significant genetic diversity in genebanks and on farmers' fields, they will still continue to require access to the diversity available elsewhere. The interdependence of countries with regard to PGRFA clearly points to the need for the international exchange of genetic resources and related information.
4. Farmers and professional breeders have traditionally relied on open access to genetic resources. In recent years, however, there has been a trend towards greater privatization of plant breeding and research, coupled with increasing pressures to enact stricter intellectual property legislation. At the same time, there is a growing recognition of the potential value of biodiversity to sustainable development. With the entry into force of the Convention on Biological Diversity (CBD), the conservation imperative has received formal recognition, as have the sovereign rights of nations to control access to their biological diversity and to make it available under terms and conditions that are agreed mutually between providers and recipients. Among other things, these conditions permit providers of original material to negotiate a fair and equitable share of the benefits arising from its exploitation.
5. The Global Plan of Action (GPA), which will be one of the principal outputs of the upcoming FAO International Technical Conference on Plant Genetic Resources, will serve as an important tool for implementing the revised International Undertaking, and indeed the CBD itself, with regard to PGRFA. The effectiveness of the GPA will depend on strengthening international cooperation and ensuring continued access by all countries to the full range of crop genetic diversity.
6. International cooperation in the field of PGRFA can provide significant benefits including:
   • increased opportunities for developing joint conservation and use strategies and for sharing responsibilities and costs regionally and/or globally, including the provision of mechanisms for safety duplication;
   • the facilitation of research partnerships and the pooling of research resources needed to exploit particular genepools effectively;
   • access to greater amounts of germplasm than are available in any one country;
   • access to improved materials;
   • access to relevant technologies developed by partner countries;
   • a greater exposure of material to a wide range of environments, thereby leading to better understanding of its properties and hence, better exploitation of its potential;
   • access by providers to information, e.g. special traits or multilocation testing data, on material that they have supplied as well as on material supplied by partners;
   • more cost-effective means of exchanging information, e.g. through shared databases and information systems;
   • access to training at a range of specialized institutions.
7. In devising mechanisms for implementing the GPA, the revised International Undertaking and the CBD, it is important to consider the suitability of the two basic approaches to the exchange of genetic resources under given circumstances. Bilateral approaches are typically partnerships of two institutions or governments, generally formalized through a contract or memorandum of understanding. Multilateral approaches involve a number of countries and/or institutions that agree collectively to terms and conditions for sharing materials and benefits. Both approaches have advantages and are consistent with the CBD.
8. Bilateral approaches may be most appropriate when a small number of countries have, or need access to, the genetic diversity of a particular species or group of species, and/or when highly expensive and specialized research gives a strong competitive advantage to a single or limited number of institutions. Such conditions may prevail in the case of some industrial crops and in certain sectors, for example pharmaceuticals.
9. Multilateral approaches may be most appropriate in situations where individual countries harbour only part of the genetic variability (i.e. the total genepool) of interest, and/or when farmers and professional breeders in many countries need access to particular resources. They are also appropriate when there is a high social stake in successful crop improvement and when the pooled efforts of many are likely to be more effective in promoting improvement than the efforts of a few. These conditions prevail for the majority of staple food crops.
10. The report examines three options for exchange systems:
    • a strictly bilateral approach
    • the current informal multilateral approach
    • a multilateral framework governed by mutually agreed rules.
11. Exclusively bilateral arrangements have rarely been reported in the case of staple food crops but are likely to be extremely complicated given the large number of potential actors (and hence individual agreements) involved, the complex pedigrees of crop lines (and hence the difficulty of assessing and apportioning benefits), the limited capacity of many partners to be able to negotiate favourable terms, and the relatively limited financial benefits that might accrue from such arrangements. The report concludes that a strictly bilateral approach to the exchange of food crop germplasm is likely to be excessively cumbersome and thus does not consider this option at length.
12. The second option represents the current approach to exchange, an informal system which comprises national programmes and other partners, including CGIAR Centres, NGOs and the private sector. This approach is both flexible and cost-effective. It has been responsible for much of the food crop germplasm collected and exchanged internationally over the past two decades and has benefited both developing and developed countries. However, a lack of clarity concerning the rights and obligations associated with participation in the system has left it open to charges of non-transparency and has tended to discourage the involvement of some important stakeholders, in particular, the informal sector. Thus there appears to be a need for a more formal approach, although one that retains the essential features of the current system.
13. The third broad option – referred to as MUSE – describes such an approach: a flexible multilateral framework governed by mutually agreed rules. The CBD would set the context for MUSE and would provide the guiding principles for the system. The MUSE rules would provide formal clarification – and protection – of the rights and obligations associated with the exchange of PGR under the terms of the CBD and the revised International Undertaking.
14. The basic MUSE framework as described would retain the strengths of the current multilateral approach but would add to its transparency by clearly specifying the rights and obligations of all members. Such a framework could accommodate the broad range of alternatives existing between the above-mentioned extremes of purely bilateral arrangements and informal multilateral approaches to exchange. For example, MUSE could make provision for benefit-sharing on a bilateral basis under certain circumstances, typically upon commercialization. Another scenario might include a fund as a mechanism for financial compensation in return for access and in recognition of the concept of Farmers' Rights. A combination of these scenarios might coexist within the MUSE framework and be applied according to circumstances. For instance, the scenario providing for bilateral negotiations might apply in the case of non-food crops only.
15. Membership in MUSE would be voluntary and would be open to all stakeholders with an interest in PGRFA. These include farming and indigenous communities, government departments and institutions, genebanks, managers of protected areas, university departments, private charitable institutions, commercial institutions and companies, regional and international research institutions, inter-governmental organizations, non-governmental organizations, etc.
16. Countries wishing join MUSE would become party to an agreement. The FAO Commission on Genetic Resources for Food and Agriculture might consider negotiating such an agreement within the framework or as part of the revised International Undertaking. In accepting the MUSE Agreement, members would agree to collaborate and to operate according to standard rules governing conditions of membership, terms of access to genetic resources, mechanisms for sharing benefits among participants, and relationships with non-members. The subsequent governance and monitoring of MUSE, including responsibility for revising the MUSE rules to meet changing needs, would rest with government members.
17. Conditions for non-government membership (private institutions, NGOs, farming and indigenous communities, etc.) would be set by the host country of the participating institute or organization whose responsibility it would be to determine how to implement and enforce these conditions at the national level. Governments might, for example, allow interested parties to join MUSE by entering into an agreement at the national level or with the system as a whole. The latter option might apply for institutes and organizations located in non-member countries or for international organizations such as the CGIAR. Once they have joined MUSE, non-government members would be bound by the same basic rules regulating access and benefit-sharing as are contained in the MUSE Agreement.
18. A system such as MUSE is likely to attract greater participation from the “informal sector” (non-governmental organizations, farmer and community groups, etc.) in mainstream genetic resources efforts than is currently the case. The MUSE rules would apply to all members and, to the extent that infringements could be detected, would be enforceable. All members would be free to pursue their own objectives as long as these were consistent with the rules of the system. At the operational level, MUSE would be characterized by a rich diversity of permanent and temporary alliances, implemented by a mixture of existing networks and new partnerships.
19. Because current arrangements for the exchange of genetic resources are not standardized (a notable exception being the standard agreements that accompany the release of materials from CGIAR genebanks), they tend to be made on a case-by-case basis. The adoption of standard terms and conditions under MUSE could greatly reduce – or avoid altogether – the necessity to conclude individual agreements for each transaction conducted between participants and could substantially reduce bureaucracy and transaction costs overall.
20. In addition to encouraging broader participation and increasing the transparency and cost-efficiency of international conservation efforts, membership in MUSE would offer a wide range of benefits. It should be noted that these are not uniquely available under MUSE. Indeed, any form of international cooperation has the potential to provide such benefits, as noted above. The principal advantage of MUSE is that it would contain mutually agreed mechanisms for ensuring that these benefits are shared equitably among participants and for protecting the rights and enforcing the obligations of all.
21. The MUSE Agreement would define such areas as:
    • the scope of the system in terms of genetic resources
    • the terms under which access would be provided
    • mechanisms for sharing benefits
    • membership terms and conditions
    • governance and decision-making mechanisms
    • rules of membership and mechanisms for monitoring and enforcement
    • mechanisms for interacting with non-members.
22. The report identifies a number of criteria that might be used to define the range of genetic resources that would be made available through MUSE (the “scope” of the system). Criteria for defining scope might include, among others: categories of plant genetic resources; conservation location (e.g. in situ or ex situ); intended use of the materials (e.g. whether they are to be used in crop improvement or for pharmaceutical purposes); whether the materials were collected before or after the entry into force of the Convention on Biological Diversity. The report notes that, at a minimum, MUSE should include all major staple food crops. Coverage might be on an inclusive basis (whereby a list would specify materials included in the scope) or an exclusive basis (whereby a list would specify what is not included).
23. In considering scenarios within the MUSE option, the report discusses the possibility of establishing a fund as a mechanism for financial compensation in return for access. This could be one of the mechanisms for recognizing Farmers' Rights. If a fund were to be included in MUSE, decisions would be needed on such matters as its establishment, governance, replenishment and disbursement. Special consideration would need to be given to developing mechanisms and guidelines for allocating the funds, and in particular, for ensuring that farmers and local communities receive adequate compensation. The fund issue is currently under discussion in other fora and therefore is not covered at length in the report.
24. Another scenario within MUSE might allow, under certain circumstances (typically when there are prospects for commercialization), an original provider of germplasm to enter into bilateral negotiations with a recipient for an appropriate share of benefits. This might be in the form of access to a commercialized product derived from the germplasm, or to technologies, royalty-free or on special terms; access to facilities, training or other services; or an appropriate share of royalties or profits arising from the product. The questions of when to enter into such negotiations and how to define “commercialization” are examined in Annex IV.
25. It is noted that in the case of commercialization of the seed of crop varieties included within the agreed scope of MUSE, profit-sharing arrangements are likely to give rise to relatively small revenues. In many cases, these could easily be consumed by the administrative and legal costs involved in negotiating benefit-sharing. However, if both providers and recipients of germplasm within MUSE determine that there are sufficient grounds to warrant bilateral negotiations, these could be carried out under standard, multilaterally agreed guidelines – thus significantly lowering costs – and possibly with legal assistance provided through the system. Options for allowing bilateral benefit-sharing within MUSE are examined in Annex IV.
26. In many countries, the signing of the Agreement would enable the MUSE terms to be enforced in that nation. In other cases, special legal arrangements would have to be made in order to be able to enforce the terms of the Agreement. These might take various forms, such as broad umbrella agreements, mechanisms for registering institutions with MUSE, or specific material transfer agreements (MTAs) governing individual exchanges. Options for addressing this and related institutional issues are examined in an annex to the report.
27. By signing the MUSE Agreement, governments would agree in advance to standard terms of prior informed consent (PIC) and would operate on the basis of standard, mutually agreed terms (MAT) with respect to the exchange of all material included in the scope of the system. The PIC and rights of local communities and of other non-government holders of genetic resources would be established through instruments determining their participation in or relationship to MUSE, and in accordance with national policy and legislation. Such instruments might in turn contain provisions for recognizing Farmers' Rights.
28. MUSE would facilitate access by all members to the materials within its scope. The collective benefits of participating in the system would also be available to all members. However special arrangements might be needed to ensure that communities and farmers providing germplasm to MUSE know where their materials are being held and how they, and other genetic resources, can be accessed. Any group or institution providing material to MUSE – whether or not they are formal participants in the system – would retain the right to have continued and unrestricted access to that material.
29. Genetic resources included in the system might be released to non-members only under certain arrangements. This would typically be through standard MTAs negotiated and agreed by all MUSE members. The conditions under which materials would be made available to non-members might be identical to the terms of access by members, or might place added obligations on recipients, such as the requirement to provide materials to the system in exchange, special requirements for the sharing of information, or a requirement to make research products available to members (or to a subgroup of members such as developing countries) on concessional terms.
30. A small secretariat would be required to ensure the effective management of MUSE. An information unit would also be needed to serve the needs of MUSE members. In addition, consideration could be given to establishing a service unit to help co-ordinate and facilitate various aspects of benefit-sharing, including the transfer of technology, and funding provided by donor agencies and others for specific projects and activities to be conducted within the framework of MUSE. Membership fees might be levied to cover the operational costs of running MUSE, including the secretariat and the information and service units.
31. If it is decided that the basic MUSE option or any of its scenarios are worth pursuing further, a number of questions need more detailed study, including the likely costs of the system, as well as various issues related to benefit-sharing, governance and implications of the system for national legislation.
32. The future development of agricultural systems world-wide requires that PGRFA remain accessible, are available under terms and conditions designed to ensure conservation and continued sustainable use, and that the benefits arising from that use are shared equitably. It is hoped that the options considered in this report will stimulate interest and contribute positively to the ongoing debate on these issues.

Organization of the Paper

Part I of the paper sets the broad context for the study and outlines a number of approaches to the exchange of genetic resources. Chapter I provides the background to the study and Chapter II reviews alternative exchange models, the uses and relevance of these options in specific situations, and their respective costs and benefits. The Multilateral System for Exchange (MUSE), a multilateral framework guided by a set of mutually agreed regulations, is introduced in this chapter.

Part II of the paper examines the MUSE option, and possible scenarios, in more detail. Chapter III describes the institutional framework and the benefits associated with participation in the system. The possible scope of the system is addressed in Chapter IV. Chapter V presents conclusions and recommendations for future action. A more detailed analysis of possible mechanisms for implementing aspects of MUSE is given in Annex IV.