International texts

The Convention on Biological Diversity, adopted at the Earth Summit in Rio in 1992, enshrines the principle of ABS in Article 15, as well as the fair and equitable sharing of benefits arising from the utilisation of the knowledge, innovations and practices of indigenous and local communities relevant to the conservation and sustainable use of biological diversity in Article 8(j).

• Convention on Biological Diversity (CBD)

The Nagoya Protocol was adopted by the Conference of the Parties to the Convention on Biological Diversity, meeting in Nagoya in 2010, for the implementation of ABS in a transparent and legally secure framework for both provider countries and users..

• Nagoya Protocol

EU regulations 

In 2014, the European Union adopted Regulation 511/2014 to ensure that Member States comply with the Nagoya Protocol.

Regulation (EU) No 511/2014 of the European Parliament and of the Council
In 2015, the European Union adopted Commission Implementing Regulation (EU) 2015/1866 of 13 October 2015 laying down rules for the application of Regulation (EU) No 511/2014 of the European Parliament and of the Council as regards the register of collections, monitoring of user compliance and best practices.

Implementing Regulation (EU) 2015/1866

In 2016, the European Commission published a guidance document on the scope and key obligations of Regulation (EU) No 511/2014 of the European Parliament and of the Council on measures concerning the compliance by users in the Union with the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilisation.

Official Journal of the European Union (communication C313/1, 27.8.2016)
Reading this document is useful for a good understanding of the scope of the regulation, the obligations incumbent on users of genetic resources, and the necessary due diligence declaration. Specific issues relating to the health and genetic resources for food and agriculture sectors are also addressed.

Regulation 511/2014 provides for non-binding instruments to assist users of genetic resources in complying with their duty of due diligence: registered collections and best practices (Articles 5 and 8 of the Regulation respectively).

A registered collection only provides users with genetic resources acquired under conditions that comply with ABS rules and are accompanied by the required documentation. As a result, users who obtain resources from registered collections are deemed to have exercised due diligence in obtaining the required information. However, this does not exempt the user from making a declaration of due diligence and verifying that the intended use is possible without having to obtain new prior informed consent and establishing mutually agreed terms for the new use. Furthermore, French Law No. 2016-1087 specifies that in the event of access prior to the publication of the law or prior to the labelling of the collection, due diligence is the sole responsibility of the user.

The European Commission establishes and maintains a Register of Collections within the Union. It currently includes three collections, including the French Collection of Plant-Associated Bacteria (CFBP), a member of CIRM, the microorganism pillar of RARe.

A recognised good practice is a set of procedures, instruments or mechanisms that enable a user implementing it to meet their obligations. The implementation of good practices thus reduces the risk of non-compliance on the part of the user, justifying a reduction in compliance checks by the competent authority of the Member State.

The European Commission establishes and maintains a Register of recognised good practices.

National regulations

In 2016, France adopted Law No. 2016-1087 for the restoration of biodiversity, nature and landscapes, Title V of which describes the terms and conditions for accessing French genetic resources and sharing the benefits (Article L 412-3 et seq. of the Environment Code).

In 2017, the first decree implementing the French law specified the terms and conditions for access to French genetic resources and associated traditional knowledge and for sharing the benefits arising from their use. It designates the competent national authorities for declarations and access authorisations, as well as for the registration of collections in the European register (Article R 412-12 et seq. of the Environment Code). Decree No. 2017-848 of 9 May 2017

The JORF Decree of 13 September 2017 establishes the standard contract for sharing the benefits arising from the use of genetic resources collected on national territory.

The Order of 20 March 2018 specifies the procedures for examining applications for registration of collections in the European register, with the creation of a committee of experts and the establishment of a dematerialised platform by the Ministry responsible for research, enabling the submission of registration applications. Another Order of 13 September 2018 appoints the experts who are members of the committee created.

Article 129 of Law No. 2019-486 of 22 May 2019 on business growth and transformation (known as the PACTE Law) establishes, on an experimental basis and for a period of three years, access to genetic resources collected from micro-organisms in mainland France that are not subject to declaration or authorisation.

Decree No. 2019-916 of 30 August 2019 on the exemption, on an experimental basis, procedures for access to genetic resources and the sharing of benefits arising from their use for micro-organisms in metropolitan France, specifies the information to be submitted each year before 1 August to the Minister for the Environment for the monitoring and implementation of the experiment established by the PACTE law.

Finally, the Order of 3 September 2019 on model species provides a definition of a model species and, in its annex, lists all species considered as such and to which, as a result, national provisions on access and benefit sharing do not apply.