The Potential Impacts Of The Nagoya Protocol On Global Public Health Research

The State Department is initiating a public process to consider the implications of Access and Benefit-Sharing (ABS) regimes for global health and biomedical research. The Federal Register Notice announcing this initiative can be found here. The State Department is interested in the impacts that implementation of the Nagoya Protocol may be having on international research collaborations, pathogen sample sharing, infectious disease research, pandemic and epidemic preparedness and response, medical countermeasure development efforts, and investor interest in vaccine development. The State Department is also requesting recommendations on what the World Health Organization (WHO) and other organizations can do to effectively protect public health equities in the context of the Nagoya Protocol and national-level ABS implementation.

The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from Their Utilization was opened for signature in October 2010 and entered into international force on October 12, 2014. To date, it has been ratified by 118 countries; the United States has neither signed nor ratified the agreement. The Protocol was meant to establish a transparent legal framework to govern access to and utilization of genetic resources. It authorizes each country to require those seeking access to its genetic resources to first obtain permission to do so. The Protocol also authorizes each party to share in the benefits arising from research and commercialization of genetic resources. This is typically accomplished through negotiation of an ABS agreement between the party seeking access and the provider country.

Under the Protocol, the term "genetic resources" is defined to mean "genetic material of actual or potential value." "Genetic material" is, in turn, defined to mean "any material of plant, animal, microbial or other origin containing functional units of heredity." Collectively, these terms have been construed by most of the Protocol parties to include human pathogens, such as bacteria, fungi and viruses. As a result, the use of pathogens for public health purposes is subject to the ABS requirements and procedures of individual countries. That is potentially problematic since the development of vaccines and other medical products to address urgent global health threats could be substantially delayed by the need for ABS agreements between manufacturers and countries. The negotiation of an...

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