The Nagoya Protocol must be observed where certain requirements are met on a cumulative basis. These stipulate that the genetic material must be a genetic resource (GR) or associated traditional knowledge obtained from a country that is party to the Nagoya Protocol after 12 October 2014. The utilisation of the genetic resource must also take place within the EU. You can find a more detailed list of these requirements and the scope here.
A user is a natural or legal person that utilises GR in the meaning of the Nagoya Protocol. Utilisation is defined as the conduct of research and development on the genetic and/or biochemical composition of genetic resources, including through the application of biotechnology as defined in Art. 2 of the Convention on Biological Diversity – CBD). You can find an EU guide to the term “utilisation”, which provides various examples and explanations, in the download section.
Genetic resource means genetic material of actual or potential value (cf. Art. 3 Regulation (EU) No. 511/2014). This may be living or dead material. Genetic material is defined as any material of plant, animal, microbial or other origin containing functional units of heredity. Material that comes from human beings is excluded, but human pathogens are not.
Traditional knowledge associated with genetic resources is defined as traditional knowledge held by an indigenous or local community that is relevant for the utilisation of genetic resources and that is as such described in the mutually agreed terms applying to the utilisation of genetic resources.
Biotechnology is any technological application that uses biological systems, living organisms, or any derivatives thereof, to create or modify products or processes for specific use.
Users have various obligations, which are set out in EU Regulation No. 511/2014:
- General due diligence obligation
- Obligation to submit Due Diligence Declarations
- Obligation to provide assistance in the event of checks
The ABS procedure of the provider country must be observed within the framework of the due diligence obligation. Information can be obtained from the National Focal Point (NFP) of the country.
In general, ABS documents first need to be obtained, then retained for 20 years after the end of the utilisation of the GR and transferred to subsequent users.
The receipt and dispatch of genetic resources should be documented. The result of any review of whether a GR falls under the scope of the Protocol or not must also be documented, as must the relevant correspondence with the competent authorities (NFP, Competent National Authority (CNA), other third parties).
The ABS Clearing-House website not only serves as a register of the parties to the Nagoya Protocol. It also provides information on the NFPs and their contact details under country profiles, enabling you to find out whether ABS regulations exist and if so, which.
Violations may have various consequences. These may include bans on utilising the genetic resource, bans on publication or fines of up to EUR 50,000. These reprisals are accompanied by a loss of reputation and the risk of not being able to conduct any further research with a specific partner in the future.
Even if the EU Regulation is not applicable to a case because it falls outside the defined scope (see under “Who does the Nagoya Protocol apply to?”), specific regulations may still exist in the provider country which govern access to the genetic resource outside the scope of the Regulation and which must also be observed.