Proposal for a Regulation of the European Parliament and of the Council on access to genetic resources and the fair and equitable sharing of benefits arising from their utilization in the Union

Author (Corporate)
Series Title
Series Details (2012) 576 final (4.10.12)
Publication Date 04/10/2012
Content Type

Genetic resources - the gene pool in both natural and cultivated stocks - play a significant and growing role in many economic sectors: 26% of all new approved drugs over the last 30 years are either natural products or have been derived from a natural product.

A broad range of players in the Union, including academic researchers and companies from different sectors of industry (for example, plant and animal breeding, biocontrol, cosmetics, food and beverage, horticulture, industrial biotechnology, pharmaceutical) use genetic resources for research and development purposes, some also use traditional knowledge associated with genetic resources.

The European Union and all of its 27 Member States are Parties to the Convention on Biological Diversity (CBD). The CBD recognizes that states have sovereign rights over genetic resources found within their jurisdiction and the authority to determine access to such resources. The Convention obliges all Parties to facilitate access to genetic resources over which they hold sovereign rights. It also obliges all Parties to share 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 Party providing these resources. However, the CBD currently provides little detail on how access and benefit-sharing (ABS) for the use of genetic resources and associated traditional knowledge should be done in practice.

The "Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from Their Utilization to the Convention on Biological Diversity" is a new international treaty adopted on 29 October 2010 by the consensus of the 193 Parties to the CBD. It is a treaty with legally binding effects that significantly expands the general ABS framework of the CBD. The Nagoya Protocol is expected to enter into force in 2014.

The Union and most of its Member States have signed the Nagoya Protocol and thereby committed themselves to work towards implementation and ratification. Union implementation and ratification of the Protocol will create new opportunities for nature-based research, and contribute to the development of a bio-based economy.

Source Link http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2012:0576:FIN:EN:PDF
Related Links
EUR-Lex: COM(2012)576: Follow the progress of this document through the decision-making procedure http://eur-lex.europa.eu/legal-content/EN/HIS/?uri=COM:2012:576:FIN
European Commission: SWD(2012)291: Summary of the impact assessment http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=SWD:2012:0291:FIN:EN:PDF
European Commission: SWD(2012)292: Impact assessment http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=SWD:2012:0292:FIN:EN:PDF
European Commission: COM(2012)577: Proposal for a Council Decision on the conclusion of the Nagoya Protocol on access to genetic resources and the fair and equitable sharing of benefits arising from their utilization to the Convention on Biological Diversity http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2012:0577:FIN:EN:PDF

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