Will Nagoya Protocol on Access & Benefit Sharing Affect U.S. Drug Development?

A current article in Genetic Engineering & Biotechnology News considers the potential implications for pharmaceutical development of a new international agreement regarding access to, and sharing of benefits from, genetic resources. See Nagoya Protocol’s Rules for Genetic Resources Pose Challenges for U.S. Drug Developers, (Aug. 24, 2011). As explained in the article, the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization is a 2010 supplementary agreement to the Convention on Biological Diversity (“CBD”). The protocol is intended to establish a framework for the fair and equitable sharing of benefits arising out of the utilization of genetic resources. It also applies to traditional knowledge associated with genetic resources that are covered by the CBD and the benefits arising from its utilization.

The article focuses on proposals to amend the protocol to require public disclosure of the source of any genetic resources and the country of origin of any traditional knowledge from which an invention sought to be patented is derived. Currently, neither the CBD nor the Nagoya Protocol explicitly requires such disclosure.

The Nagoya Protocol will enter into force 90 days after the fiftieth instrument of ratification. The United States has not signed the protocol, and indeed cannot do so until it has ratified the CBD. President Bill Clinton signed the CBD in 1993, but the convention has never been ratified by the U.S. Senate.

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