Nagoya Protocol – Access and use of genetic resources
The Nagoya Protocol on Access and Benefit-Sharing (ABS) is an international agreement aimed at a fair and equitable sharing of the benefits arising out of the utilization (research and/or development) of genetic resources (and/or traditional knowledge associated with them). Website of Nagoya-Protokoll.
- A genetic resource is any material of plant, animal, microbial or other (non-human) origin that contains functional units of heredity, or derivatives of a genetic resource (e.g. enzymes, proteins, metabolites) with actual or potential value.
- Excluded are organisms that are the subject of special treaties (e.g. International Treaty on Plant Genetic Resources for Food and Agriculture => 35 food and 29 feed plant species e.g. wheat and other cereals, apple, strawberry, field bean, various cabbage species; however vines are not listed), and any kind of human genetic material.
- Utilization of genetic resources means conducting research and/or development activities on the genetic and/or biochemical composition of these resources or their derivatives.
- Applies to any genetic resource collected within the scope of the Nagoya Protocol as of October 14, 2014.
- 141 members, 1 ratified but not yet an official member (Costa Rica)
- Not signed by: Italy, Poland, USA, Australia, New Zealand, Russia and other countries yet national ABS regulations may apply, so please contact VF 1 to check.
- For details on the participating countries please refer to absch.cbd.int/en/
- During the project proposal process please check whether you are within the scope of the Nagoya Protocol - see the checklist.
- Before acquiring a genetic resource, the user must be granted access obligations by the provider country (the country where the genetic resource is located in situ) in the form of a PIC (Prior Informed Consent).
- Conclusion of benefit-sharing obligations in the form of mutually agreed terms (MAT): contractual obligations between the provider country and the user of the genetic resource (MTA - Material Transfer Agreement):
- MATs specify monetary and / or non-monetary benefit-sharing measures.
- MATs regulate what can be done with the genetic resource (commercial or non-commercial research), who will be the user of this resource, for how long it will be used, whether resources can be passed on to other scientists, etc.
- If users of a genetic resource have PIC and MAT, the provider country can issue an Internationally Recognized Certificate of Compliance (IRCC) to prove the legality of the access and the establishment of the MATs and can decide on the publication on the ABS Clearing House website.
What does this mean for the HGU?
- Since 2018, compliance checks have been carried out by the competent national authority of the country in which the resource is accessed and used (in Germany: Bundesamt für Naturschutz).
- VF1 checks whether users of genetic resources have fulfilled their due diligence obligations.
- Project principal investigator of the HGU is responsible for obtaining the necessary documents and their documentation:
- Completion of the Nagoya checklist by project principal investigator
- Project principal investigator contacts VF1 to jointly review the necessary steps
- Project principal investigator fills out application form for MTA, followed by preparation of a Material Transfer Agreement (MTA) etc. by the legal department.
- Signed original MTA filed in the legal department, uploaded to FIS by project principal investigator.
- Violations of EU Regulation No. 511/2014 (Regulation on measures for users to comply with the provisions of the Nagoya Protocol) constitute administrative offenses, fines of up to EUR 50,000 possible.
If you have any further questions, please contact the VF1/Office of Research and Innovation Services directly.
