Access and Benefit-Sharing are governed by four important international agreements.
- The Convention on Biological Diversity (CBD, in force since December 1993).
- The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits arising from their Utilization (Nagoya Protocol) under the CBD (in force since October 2014).
- The International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA, in force since June 2004).
- The Pandemic Influenza Preparedness (PIP) Framework (in force since May 2011).
In the European Union, the Nagoya Protocol is implemented through EU Regulation 511/2014 (the EU ABS Regulation) and EU Implementing Regulation 2015/1866.
CBD, Nagoya Protocol, ITPGRFA and PIP Framework
The Convention on Biological Diversity (CBD) and the Nagoya Protocol apply to all genetic resources, except human genetic resources. This includes plant, animal, microbial and viral resources, and both terrestrial and aquatic species. The agreements apply equally to bred, wild and domesticated species. All users should comply with the provisions of the CBD and the Nagoya Protocol as translated into national legislation, regardless of the type of use or the identity of the user.
The ITPGRFA only applies to plant genetic resources for food and agriculture; it is thus much more specific and has a more limited scope. This special ABS instrument establishes a Multilateral System (MLS) for Access and Benefit-Sharing involving a limited number of staple crops and forages. The PIP Framework only applies to influenza viruses with human pandemic potential. It is an international ABS instrument that aims to improve pandemic influenza preparedness and response by establishing a system for 1) the sharing of H5N1 and other influenza viruses with human pandemic potential and 2) access to vaccines and sharing of other benefits. For all other genetic resources (of plant, animal, microbial or viral origin), the provisions of the CBD and the Nagoya Protocol concerning ABS will generally apply, unless a Party has decided to apply the ITPGRFA for regulation of access to their plant genetic resources for food and agriculture.
EU Regulations on the Implementation of the Nagoya Protocol
In May 2014 the European Union Regulation 511/2014 to implement the Nagoya Protocol in the EU and to enable EU-wide ratification of the Nagoya Protocol came into force. This Regulation is applicable from 12 October 2014, when the Nagoya Protocol entered into force. It applies to all use of genetic resources in the EU, and lists obligations on users of genetic resources in the EU.
EU Implementing Regulation 2015/1866 lays down detailed rules concerning the implementation of Articles 5, 7 and 8 of Regulation (EU) No 511/2014 which refer to the register of collections, the monitoring of user compliance, and to best practices.