Nagoya Protocol

The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization was adopted on 29 October 2010 in Nagoya, Japan, at the tenth Conference of the Parties (COP-10) to the Convention on Biological Diversity (CBD). It entered into force on 12 October 2014, ninety days after the fiftieth instrument of ratification was deposited.

The Protocol operationalizes the third objective of the CBD: the fair and equitable sharing of benefits arising from the utilization of genetic resources. It establishes a framework requiring users of genetic resources (typically researchers, pharmaceutical, cosmetic, or agricultural companies) to obtain prior informed consent (PIC) from the country providing the resource and to negotiate mutually agreed terms (MAT) specifying how monetary or non-monetary benefits will be shared with that provider country.

Key features include:

• Coverage of genetic resources and traditional knowledge associated with genetic resources held by indigenous peoples and local communities, requiring their consent and benefit-sharing where domestic law recognizes their rights.
• Obligations on parties to designate national competent authorities and a national focal point, and to issue an internationally recognized certificate of compliance.
• Establishment of the Access and Benefit-sharing Clearing-House (ABS Clearing-House) for transparency.
• Compliance measures requiring user-country parties to ensure that genetic resources used within their jurisdiction were accessed lawfully.

The Protocol is implemented in the European Union through Regulation (EU) No 511/2014. Notable non-parties include the United States, which has never ratified the parent CBD. Tensions persist over digital sequence information (DSI) — whether genetic data stored in open databases falls within the Protocol's scope — a question debated at successive CBD COPs and partially addressed by the multilateral DSI mechanism agreed at COP-15 in Montréal (2022).