Genetic Resources: Draft Intellectual Property Guidelines for Access and Benefit-sharing Contracts (link)

March 5, 2004

Geneva, 04 Mar 2004

OVERVIEW

Genetic resources can provide an important input for research and the development of new products, in an increasingly broad range of technological and industrial sectors. The terms and conditions of access to genetic resources, the exercise of prior informed consent by the providers of genetic resources, and the resulting arrangements made for the sharing of benefits from their use and development, are critical issues. Existing international law and a number of regional, national and sub-national laws and regulations set the framework for exercising prior informed consent and determining the terms and conditions of access as well as benefit-sharing. Key elements of international law include the Convention on Biological Diversity (CBD) and the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGR) of the Food and Agricultural Organization (FAO). The CBD, adopted in 1992, provides an international framework for access and benefit-sharing for genetic resources. The ITPGR, adopted in 2001, covers plant genetic resources for food and agriculture (PGRFA) and will establish a multilateral system of access and benefit-sharing for certain PGRFA. In conformity with the access and benefit-sharing provisions of these international instruments, national regimes have been developed to regulate access to genetic resources.

The detailed arrangements for specific acts of access and benefit-sharing are often set through permits or negotiated licenses, contracts or agreements (including those termed 'material transfer agreements' or MTAs). Such agreements generally operate within the framework of the specific national regimes that govern access to genetic resources, and in line with other laws regulating the environment, public resources, indigenous and community rights and regional development, as well as general contract and property law. There are also broader international guidelines that influence the overall approach taken to such agreements. In particular, to assist with the implementation of the access and benefit-sharing provisions of the CBD, the Bonn Guidelines on Access to Genetic Resources and Fair and Equitable Sharing of the Benefits Arising out of their Utilization ('Bonn Guidelines') were adopted by the Conference of Parties (COP) of the CBD. The Guidelines are meant to assist Parties to the CBD when developing and drafting legislative, administrative and policy measures on access and benefit-sharing, and also when developing contracts and other arrangements under mutually agreed terms for access and benefit-sharing.

Within access and benefit-sharing agreements, the specific arrangements made for intellectual property (IP) management can be crucial in ensuring that they operate to create benefits from access to genetic resources, and in particular to ensure that those benefits are shared equitably and the interests and concerns of the resource providers are fully respected. IP issues that can be determined in agreements include the entitlement to seek IP rights in inventions and other results of research using the resources, ownership and licensing of such derivative IP, responsibility for maintaining and exercising IP rights. Some commentators have pointed to the limitations of contracts as a means of defining and governing relationships in relation to the access and use of genetic resources. However, since this approach is already widely used in the field, and is required under many national genetic resource regulations, stakeholders have called for guidelines on the IP aspects of contracts concerning access and benefit sharing.

. As a result, the Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore ("the Committee") took up the development of such guidelines from its first meeting as one of its tasks. It has conducted extensive discussions and information gathering on IP aspects of contractual agreements for access to genetic resources and benefit-sharing. This has included:

developing four general principles, discussed at its second session, as the basis for further development of Guide Contractual Practices, based on compiled existing contracts;
compiling and agreeing upon a detailed questionnaire, concluded at its third session, and widely distributed since then; and
a trilingual online database concerning IP aspects of existing agreements or contracts for access and benefit-sharing, launched at the fourth session and further developed at the fifth session.

The Committee has therefore completed the first stage of a two-step approach adopted by the Committee at its second session.1 The agreed second stage of this approach is for the "principles identified [by the Committee to] be applied for the development of guide practices…, based on the existing practices and clauses".2 The CBD COP has since encouraged WIPO to "make rapid progress in the development of model intellectual property clauses which may be considered for inclusion in contractual agreements when mutually agreed terms are under negotiation."

The present document accordingly progresses this second stage, and continues the systematic and balanced development of Guide Contractual Practices on the basis of the identified principles, the database of sample contracts, and the guidance provided by Committee members. For this purpose, the present document builds on the principles that were identified and adopted by the Committee at its second and third sessions for the development of Guide Contractual Practices. The Annex to the document contains draft Guide Contractual Practices which reflect these principles, directions given by Committee members, and information resources collected over the past two years. The Committee participants are invited to comment on the draft Guide Contractual Practices and to further elaborate the principles which were previously identified. These are submitted as a preliminary draft, based on the Committee's work so far, but may form the basis for a specific outcome within the terms of the Committee's current mandate. Accordingly, Committee participants are invited to assess and comment on the operational principles and the draft Guide Contractual Practices contained in the Annex. In recognition of the need for the Committee's work on IP aspects of access and benefit-sharing contracts to respect and complement other international processes, Part IV of the document reviews relevant policy developments taking place in the intergovernmental processes of the CBD and the FAO.

Genetic Resources: Draft Intellectual Property Guidelines for Access and Benefit-sharing Contracts (link)

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