The Nagoya Protocol is in effect since 12 October 2014. It is a supplementary agreement to the Convention on Biological Diversity (CBD) and specifies the requirements for ABS under Article 15 of the CBD. It sets out the legal framework for regulating access to genetic resources and the fair and equitable sharing of the benefits arising from their use. The requirements of the Nagoya Protocol also apply to traditional knowledge that belongs to genetic resources (= associated traditional knowledge).

Conditions for regulating access

Countries wishing to make access to their genetic resources/associated traditional knowledge subject to Prior Informed Consent (PIC) and Mutually Agreed Terms (MAT) shall provide for transparency of their domestic ABS legislation.
PIC and MAT are negotiated bilaterally between the providing country and the recipient.

Requirements for compliance with ABS regulations

Countries where genetic resources/associated traditional knowledge are used must ensure that this use takes place in compliance with applicable ABS regulations.
They are obliged to set up check points to monitor compliance among users of genetic resources/associated traditional knowledge.

Implementation of the Nagoya Protocol in the EU

• Access: Each EU member state decides for itself whether it makes access to genetic resources dependent on PIC and MAT in accordance with the Nagoya Protocol. While the majority of member states have decided not to regulate access, some countries have adopted access legislation. Information on the current status of existing regulations in the EU can be found on the information page of the CBD Secretariat on ABS (ABS Clearinghouse). 

• User controls: In the EU, user controls are subject to common rules laid down in Regulation (EU) No. 511/2014.

Implementation of the Nagoya Protocol in Germany

• Access: Germany does not require Prior Informed Consent (PIC) and the establishment of Mutually Agreed Terms (MAT) to access genetic resources.
• User controls: In addition to the EU Regulation, the German Implementation Law too effect on 1 July 2016. The responsible competent national authority in Germany is the Federal Agency for Nature Conservation.