Does the Nagoya Protocol apply to me?
These regulations are relevant for your research project if
- you are working with non-human genetic material AND
- this material is obtained from or isolated/collected in a country which is a party to the Nagoya Protocol and which has adopted regulations on Access to genetic resources and/or on Benefit-Sharing (“ABS laws”) AND
- you are conducting research or development studying the genetic or biochemical properties/functions of the material. Examples:
- Genetic analysis of bacteria to investigate their sugar metabolism → Nagoya Protocol applies
- Genetic analysis of bacteria for taxonomic classification → Nagoya Protocol does not apply
- Exclusions from the Nagoya Protocol: organisms covered by specialised treaties (such as the International Treaty on Plant Genetic Resources for Food and Agriculture or the Pandemic Influenza Preparedness Framework) and used under the terms of those treaties
Your obligations
If all of the above applies to your research project, you are obligated to
- at Provider Country level: Comply with its ABS laws.
- Access obligations: Prior to the acquisition of the genetic material, access to the resource is usually granted by the Provider country via a Prior Informed Consent (PIC) permit.
- Benefit-Sharing obligations: The contractual obligations for the utilisation of the genetic resource are usually agreed in the form of Mutually Agreed Terms (MATs) between the Provider Country and the User.
- The Provider Country may issue an Internationally Recognized Certificate of Compliance (IRCC) confirming the User's compliance with its ABS laws.
- at EU level: Submit a due diligence declaration via the EU web tool DECLARE if you have received research funding in connection with the utilisation of the genetic resource.
- keep all documentation on access, utilisation and transfer of the genetic material for 20 years (from the end of the period of utilisation).
- Important: Even if the Provider Country has not adopted ABS legislation, it is recommended to document this circumstance.
- Transfer of genetic material:
- If you transfer genetic material (covered by the Nagoya Protocol) to a third party, you must make sure that the transfer is permitted under the MATs and inform the recipient of the terms of use.
- If you receive genetic material from a third party, you are obliged to verify that the material has been accessed legally (for example, via PIC and MAT documents).
