Access to genetic resources and sharing of benefits arising from their utilisation (Nagoya Protocol)

KEY POINTS

By approving the protocol on 16 May 2014, the EU contributed to the required 50 ratifications worldwide which enabled the Nagoya Protocol to come into force on 12 October 2014. As a result, the first meeting of the parties to the protocol (COP-MOP 1) took place at the biennial high-level meeting of the Convention on Biological Diversity (CBD) from 13-17 October 2014 in South Korea, at the same time as the 12th meeting of the Conference of the Parties to the CBD (COP 12).

Access and benefit sharing

• The Nagoya Protocol implements the third aim of the CBD, access and benefit sharing (ABS), which focuses on the fair and equitable sharing of the benefits arising from the use of genetic resources, including by appropriate access to genetic resources and appropriate transfer of relevant technologies.
• Genetic resources are genetic materials of actual or potential value, from natural or cultivated stocks (e.g. seed banks or botanical gardens). These resources are typically used by a wide range of sectors in nature-based research and development as a basis for innovation, such as for new medicines, chemicals or cosmetics.
• The CBD recognises countries’ sovereign rights over their natural resources. ABS in the context of the Nagoya Protocol is based on this principle. Parties to the protocol have the authority to decide whether they wish to regulate access to their genetic resources and set out conditions for the sharing of benefits (e.g. through rules and procedures for prior informed consent and the negotiations of mutually agreed terms with the user of genetic resources).
• The Nagoya Protocol also applies to the use of traditional knowledge associated with genetic resources held by indigenous peoples and local communities.
• The protocol sets out mandatory rules on compliance for all parties, in order to monitor the use of genetic resources once they leave the provider country.
• The protocol will create greater legal certainty and transparency for both providers and users of genetic resources, whilst promoting benefit-sharing. The benefits generated and shared under the guidance of the protocol should contribute to support the conservation of biological diversity and the sustainable use of its components (the first and second aims of the CBD).

Regulation (EU) No 511/2014, the access and benefit sharing regulation (ABS Regulation), which implements the compliance measures of the Nagoya Protocol at the EU level, entered into force on 9 June 2014 and has applied since the Nagoya Protocol itself entered into force for the EU, on 12 October 2014.

Implementing Regulation (EU) 2015/1866 contains measures on specific aspects provided for in the ABS Regulation, in particular registered collections, best practices and monitoring of user compliance. It was adopted by the European Commission on 13 October 2015, and entered into force on 9 November 2015.