Beyond Access - Identifying options for User Country Legislation to Meet the Fair and Equitable Benefit Sharing Commitm

1. Beyond Access -Identifying options for User Country Legislation to Meet the Fair and Equitable Benefit Sharing Commitment Morten Walløe Tvedt, Senior Research Fellow, Lawyer Co-authored with Ms. Tomme Rosanne Young Private consultant, previously: Legal Advisor IUCN, Lawyer Work-shop Bremen 15.-16. February 2008

2. My Background: Animal Genetic Resources: • Process Patent Protection in the Field of Animal Breeding and Farm Animal Genetic Resources (In co-operation with Magnus Finckenhagen, forthcoming 2008) • FAO project about AnGR: Animal Genetic Resources – Exchange, Conservation and Sustainable Use – Policy and Regulatory Options (January 2007, available on www.fni.no); • Patenting in the Field of Animal Breeding and Animal Genetic Resources (In print 2008, ACTA Scandinavia) Marine and Fish Genetic Resource: • Access to and Property Rights of Aquaculture Genetic Resources – Norwegian Perspectives (The Journal of World Intellectual Property (2006) Vol. 9, no. 4, pp. 392–412) International Patent Law and Genetic Resources: • A Path to One Universal Patent (Journal of Environmental Policy and Law, 2007) • How will the new WIPO draft Substantive Patent Law Treaty affect Genetic Resources? (Journal of World Intellectual Property 2005 no 3 May); Bioprospecting and the Convention on Biological Diversity: • Beyond Access – Options for implementing CBD in User Countries (2007 with Tomme R. Young) • The Disclosure Requirement in the Norwegian Legislation – Is It Likely to Lead to Fair and Equitable Benefit-Sharing? (In print 2008, Journal of Environmental Policy and Law) • Elements for Legislation in User Countries to Meet the Fair and Equitable Benefit-Sharing Commitment (The Journal of World Intellectual Property (2006) Vol. 9, no. 2, pp. 189–212)

3. Beyond Access – a book in a series: • Addressing the Problems of Access: Protecting Sources, While Giving Users Certainty • Beyond Access – Options for implementing CBD in User Countries • A Moving Target: Genetic Resources and Options for Tracking and Monitoring their International Flows • Contracting for ABS: The Legal and Scientific Implications of Bioprospecting Contracts • Covering ABS: Addressing the Need for Integration in the ABS Regime • Synergies (awaiting financing)

4. Provider Countries (access): CBD art 15 1 to 6 Bonn Guidelines Legislation in a number of countries A body of contractual practices A body of literature about access ‘Learning modules’ ABS – What we know: User countries: • CBD art 15.7 • No experiences from implementation in national legislation • (Disclosure-discussion) • (Certificate-discussion) • Focus in Beyond Access

5. The approach Beyond Access: • A comprehensive search and study of the literature and existing acts Exhaustive over-viewed ABS on the user-side • Studies of all OECD-countries • More detailed looks at a selection of developing and developed countries as user countries • (Not about TK, only genetic resources) A premise for the work: • All countries member to the CBD work under the intention of complying with the objectives and obligations of the CBD, including the benefit sharing obligations This premise led us to the following task for the book: • Provide technical legal analysis of the possibilities, needs and obstacles for meeting benefit-sharing.

6. Scope of “Beyond Access” Main task: to look beyond the act of access; and to analyse the legal situation regarding what happens with genetic resources when they have left the providing or source country. • User-country obligations are • Obligations of ALL Parties • Critical to creating a functional system of ABS • Basis of “remedies” and enforcement • Users and the GR may be outside the source country • Enabling oversight/monitoring • Authorising remedial action

7. What we found: • There is a lack of incentives for user countries to implement legislation • Lack of incentives for private companies and other users of genetic resources to enter into agreements • There is a lack of incentives for companies to comply with the contracts or relate to ABS • The attention is at the ‘Access’-side of the ABS • The discussions of obligations upon the users of genetic resources in developed countries is absent. (Possibly in change after the last EU proposal to the Geneva-Meeting)

8. Outline of Beyond Access: • Introduction: Looking Beyond Access • The ABS Regime and the User • User Country Compliance with the Bonn Guidelines • Analyzing the “Building Blocks” of the ABS Concept on the User Side • Applying Concepts of Valuation and Equity to Genetic Resources • Measures that Can Be Taken to Meet the User-side Commitment of the CBD Parties • Conclusions: User-side Measures – A Necessary Element of the International Regime on ABS Coda: Beyond Beyond Access – Other User-side ABS Obligations in the CBD

9. What are the ’Benefit-sharing’-obligations in ABS? • 7.(1) Each Contracting Party shall take legislative, administrative or policy measures, […] with the aim of sharing in a fair and equitable way the results of research and development and the benefits arising from the commercial and other utilization of genetic resources with the Contracting Party providing such resources. • 7.(2) Such sharing shall be upon mutually agreed terms.

10. Current status • Access “measures” are not required in text, but may be needed or useful • Clarifying mechanisms • Demonstrating the difference among national views of ABS and its components • Obstacles to streamlining process • Results create stresses at present • NO “user-side” measures under Article 15.7* have yet been adopted in any country • Lessons from “provider-side measures” • Lessons from other relevant measures

11. Obstacles to ABS and the development of User Measures • Legal certainty • International provisions addressing private ABS actions • Applying conventional contractual law to a new concept of resource-based ownership or rights • Lack of incentives in system construction • Need to identify, interpret and apply foreign law

12. (A)BS Building blocks on the user-side: Three triggers for (A)BS – Benefit-sharing: • The basic term “ genetic resources”; • The actual trigger of the obligation: “the commercial and other utilization” of GR; • The time for the sharing: “benefits arising” from the utilization of genetic resources The consequence of the three triggers of the obligation: • “sharing in a fair and equitable way the results of research and development and the benefits arising” How can benefits be shared: • Each Contracting Party shall take legislative, administrative or policy measures, […] with the aim The practical way to carry out the sharing of the benefits: • Such sharing shall be upon mutually agreed terms.

13. The first trigger – Genetic resources: ABS targets genetic resources, not biological resources, This needs to made operational • Alt 1: “Genetic resources” as synonymous with “biological resources” • Alt 2: “Genetic resources” as tangible “genetic material” • Alt 3: “Genetic resources” refers to intangible “genetic information” • Alt 4: “Genetic resources” combines physical and informational elements

14. The second trigger – “the commercial and other utilization” The B-Sh obligation applies only when genetic resources (not biological resources) are being used (utilised): There is a need to develop and specify the concept of “utilisation” to be applicable by courts • Develop categories of utilization of genetic resources (South Africa Regulation) • Develop descriptive criteria for identifying utilization of genetic resources • Particular ways to define types of utilisation for either specific species and/or groups of organisms (plant genetic resources, IT-PGRFA). Why define the utilization-points? It gives an objectively determinable point of reference to determine when the benefit sharing obligations are triggered. • Potential task for the Ad Hoc: Define more specifically which types of uses of GR that shall trigger benefit-sharing

15. Third trigger – arising out of utilization of GR There is a need to define more in detail when the benefit-sharing shall be transferred (as a consequence of utilisation): • “Arising” – benefits must have been materialising • (Could be liquidated and thus pre-paid, milestones etc.) • The need: Define in more detail when benefit-sharing shall happen and how

16. The meaning of “fair and equitable” The more specific understanding and application of this term needs to be developed in order to have a more applicable One crucial part of the compromise and balance in the CBD as a whole • Developing countries undertook an obligation of conservation of biological diversity; partly as a trade-off for benefit-sharing • Benefit-sharing can be seen as a measure to create funding to promote conservation of biological diversity • Paying a contribution to the world biodiv-heritage • Equity is a legal tool in common law and there is a need to explore more in detail how those principles can be taken into the practical determining of the accurate level of benefits to be shared

17. Mutually agreed terms – the practical elements of sharing The second MAT-mechanism in Article 15: • Not sufficient to one-sided ship off ”some benefits” • The terms and conditions must be mutually agreed – use of contracts • By having general rules which are applicable to all, it might create an incentive to enter into agreements

18. Art 15.7 an obligation upon all user countries • The obligation according to Art. 15.7: countries shall take legislative, administrative or policy measures, as appropriate, • ”Shall take” means a strict obligation to act • Freedom for countries to choose between legislative, administrative or policy measures • If experience shows that the measures take are not sufficient to promote benefit sharing – does the CBD allow for countries not to take any further action?

19. Obstacles for (A)BS: • Applying conventional contractual law to a new concept of resource (2.7.3) • Requiring compliance with source country ABS law (3.3.1, and Tommes Remedy-paper) • Enforcing the rights of foreign providers under user country law (3.3.3) • …and more (see Beyond Access)

20. Potential elements for further work: The use of incentives and motivation factors (section 6.2) • Elimination of perverse incentives • Create a disincentive for non-compliance • Create positive incentives and motivations for compliance Develop more clarity for the background-law which could help ABS-contracts more easily to be applied and enforced by courts.

21. Potensial elements for furter work: • The user-side legislative challenge: Clarity on how source-country law can be respected in user-countries • Further develop and make operational the three triggers of the benefit-sharing obligation – the content of the terms in Art 15.7 need to be developed further

22. IUCN, Tomme, Daniel, Ann Thanks to the German Federal Ministry for Economic Cooperation and Development (Bundesministerium für wirtschaftliche Zusammenarbeit und Entwicklung or BMZ) And you for your attention Morten Walløe Tvedt, mwt@fni.no, www.fni.no Tomme R. Young, tomme.young@gmail.com