Every country has rights over the genetic resources that exist within its borders, including animals, plants and organisms.
The Nagoya Protocol is an international legal framework that enables equitable sharing of genetic material (plant, animal, microbial, other) including the traditional knowledge associated with the genetic resources, and the benefits that arise from their use.
The Nagoya protocol legislation was adopted by Europe through Regulation (EU) No. 511/2014 and came into force on the 12th of October 2014 and it was brought in as UK Law through the statutory instrument No. 821 ‘The Nagoya Protocol (Compliance) Regulations 2015’ The legislation is enforced by the office for product safety and standards.
The Nagoya Protocol establishes a framework that helps researchers access genetic resources for biotechnology research, development and other activities, in return for a fair share of any benefits from their use.
In simple terms it aims to ensure that owners or guardians of genetic resources receive a “fair share” of any benefits that arise from research conducted.
Individual academics and researchers in the University have a legal obligation to comply with the Nagoya Protocol.
The Nagoya Protocol may become relevant:
- When applying for a research grant or being awarded a research grant
- you may be required to demonstrate compliance
- planning overseas fieldwork, or planned sample collection
- seeking project approval (departmental)
- buying genetic resources
- providing or accessing genetic resources to/from other researchers, universities, or other third parties
- patenting inventions or discoveries or seeking to commercialise technologies
Sample collection directly from country of origin
- Check the Access and Benefit-Sharing Clearing-House website (ABSCH) to see which national laws, procedures apply, and how to make contact.
- Make all reasonable efforts to gain prior, explicit informed consent. You must seek agreement of appropriate terms and conditions to govern your access. This may be Mutually Agreed Terms (MAT), or possibly (less likely) in the form of a Materials Transfer Agreement (MTA). The provider country should issue a permit and publish a record on the ABSCH website, which will then trigger an internationally recognised certificate of compliance. Depending on the local government arrangements this may be time consuming.
- Check whether any other authorisations or permits are needed (e.g. export licence, specific access)
- Keep records for 20 years, which may be audited by the regulator.
Obtaining material from a collaborator, repository etc.
- Confirm whether informed consent and a MAT were established at the original point of collection or access, and ensure these allow a transfer to you for the purposes envisaged - ask for evidence of these, possibly the registered certificate of compliance
- If these are available an appropriate MTA can then be put in place with the third party.
- If they are not available, it may not be possible to agree the transfer. The alternative is to apply informed consent and a MAT with the original providing country.
Transferring material subject to the Nagoya Protocol:
- Ensure the purpose for which it is being provided is in line with the original access and benefits-sharing arrangement, and informed consent
- Ensure an appropriate agreement is in place, e.g. MTA, and the any conditions attached are passed on.
- Maintain records for 20 years.
Your college Pre-Award and Contracts team can advise you with respect to MTAs.