The Nagoya Protocol
Researchers have a legal obligation to comply with the Nagoya Protocol on access to genetic resources and the fair and equitable sharing of benefits arising from their utilization (‘the Protocol’).
The Nagoya Protocol is an international agreement that ensures that genetic resources – and traditional or local knowledge associated with them – are not unfairly exploited. It ensures they been accessed in accordance with applicable laws implemented by the source country.
The protocol was implemented into UK law through ‘The Nagoya Protocol (Compliance) Regulations 2015’. The aim is to provide a transparent legal framework for the fair and equitable sharing of benefits arising from the utilization of genetic resources. This contributes to the conservation and sustainability of biodiversity.
Does it apply to my research?
Please complete the checklist for researchers, which will help you to determine whether the protocol applies to your research.
The protocol applies to any genetic material (plant, animal, microbial, other), and the local or traditional knowledge relating to the genetic material. It does not include human genetic resources or genetic resources already governed by specialised international instruments (eg the International Treaty on Plant Genetic Resources for Food and Agriculture).
It is advisable to consult the Access and Benefit-Sharing (ABS) Clearing-House website prior to commencing research. This lists the countries that have ratified the protocol. It is also important to check the legislation of the country from which the genetic materials or traditional knowledge originate, even if they have not ratified the Protocol. They may have their own additional local or national laws regarding access.
For direct access to genetic resources (i.e. materials obtained directly from the country of origin by the researcher):
- using the ABS Clearing House, determine which national laws or procedures apply and how to make contact with the relevant authorities
- take all reasonable measures to obtain explicit Prior Informed Consent (PIC) to access the genetic resources. This may be in the form of Mutually Agreed Terms (MAT) or possibly in the form of a Material Transfer Agreement (MTA)
- if you are unsure what is required, contact that country’s named ABS National Focal Point designated under the protocol to confirm
- the provider country should issue a permit for you to access the materials, and should publish a record of the agreement on the ABS Clearing House website
- this will trigger an Internationally Recognised Certificate of Compliance (IRCC), this may be time-consuming
- check whether you need other permits (eg export control, access to protected areas)
- the Competent National Authority in the provider country issues a national permit or its equivalent to the user and publishes a record on the ABS Clearing House website
- keep records for at least 20 years after the end of utilization, these may be audited
For indirect access to genetic resources (i.e. the materials are accessed from a third party, such as a collaborator, private/registered collection, botanical garden):
- confirm whether PIC and MAT were established by the intermediary when the resources were originally accessed (or seek records confirming that PIC and MAT were not required), and ask for evidence of these
- this will likely be in the form of an IRCC, but may alternatively be in the form of equivalent information
- check that a transfer to you for the purposes envisaged is permitted under the original terms of use
- if PIC and MAT are not available, or if your envisaged use of the materials is not allowed under the original IRCC, apply for new or modified PIC and MAT from the provider country
- keep records for at least 20 years after the end of utilization, these may be audited
If you are transferring materials that are subject to the protocol:
- ensure that the provision of access is consistent with the original access and benefit-sharing arrangements (MAT and PIC)
- ensure that an appropriate agreement (e.g. MTA) is in place to transfer the materials, and provide new users with the IRCC (or equivalent information), access permits and MATs, where applicable. This information must be kept by the new holder and included in any subsequent transfers of the material
- retain records of any transfers, sharing or access for at least 20 years after the end of utilization, these may be audited
If you have any queries regarding the Nagoya Protocol, please contact: res.policy@ncl.ac.uk