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. This is an international agreement that implements the access and benefit-sharing obligations of the Convention on Biological Diversity (CBD). It is intended to ensure that a genetic resource (or local knowledge about it) is not exploited without reference to the country or community in which it originated.
Researchers who source or use resources in scope of the Protocol are required to ensure that genetic resources, and traditional knowledge associated with those resources, have been accessed in accordance with applicable access and benefit sharing laws implemented by the source country.
The Protocol came into force on 12th October 2014. EU Regulation 511/2015 implemented the Protocol in the EU and establishes procedures which users are required to follow to demonstrate ‘due diligence’. The legislation is implemented and enforced in the UK by the Office for Product Safety and Standards (OPS&S).
The protocol and related due diligence requirements will apply if:
a) The research involves a genetic resource (GR) that is in scope of the protocol; and
b) The utilisation of the GR is in scope of the protocol; and
c) The country from which the GR originated has ratified the Protocol and established applicable access measures. Note the Protocol may apply whether the GR is accessed directly from the country of origin, or via a third party; and
d) The genetic resources were originally accessed from the country of origin after 12 October 2014. This includes access from an ex-situ collection in the country of origin, regardless of when the resources entered the collection.
Note that even if the Nagoya Protocol does not apply (either because the country has not established legislation under the protocol, or the GR was accessed before the protocol came into force), some countries may have relevant access and benefit-sharing legislation with which you may need to comply.
A checklist for researchers is available to help you determine whether the protocol applies to your research. You should use this in conjunction with the information on this page.
- Genetic Resources (GR): any material of plant, animal, microbial or other origin (excluding human) containing functional units of heredity (e.g. genes and DNA) which is of actual or potential value; or their derivatives, e.g. proteins, lipids, enzymes or RNA.
- Traditional Knowledge (TK): knowledge, know-how and practice of indigenous and local communities relevant for the utilisation of the GR.
- For the purposes of the protocol, ‘utilisation’ means to conduct research and development (R&D) on the genetic and / or biochemical composition of genetic resources, including through application of biotechnology. This includes basic and applied research.
The Protocol does not apply to
- Human genetic material
- Genetic resources already governed by specialised international agreements that are consistent with the Protocol, e.g. the International Treaty on Plant Genetic Resources for Food and Agriculture; the WHO Pandemic Influenza Preparedness Framework.
- Genetic resources as traded commodities
- Genetic resources that are used for the maintenance of a collection for conservation purposes (i.e. there is no intention to undertake research involving the GR).
- Genetic resources that are being used as a tool in research, i.e. the GR is not the object of the research, but serves to confirm or verify the desired features of another product (e.g. animal models, tools for preclinical or clinical testing, GR used incidentally as an agent in an experiment).
You will need to check the Access and Benefit Sharing Clearing House (ABSCH) to determine
a) Whether the country has ratified the protocol
b) Whether they have establishes measures to regulate the genetic resource you intend to use. If it is unclear whether relevant legislation exists, you will need to contact the National Focal Point listed on the ABSCH to request information.
The University of Cambridge has produced a helpful guide to the ABSCH which will help you identify the relevant information.
You should notify Research & Innovation Services at an early stage if you are accessing material that is subject to the protocol. You will need to:
The checklist for researchers will help to guide you through the due diligence process, and you should use the checklist in conjuction with the information on this page.
Access measures with which you may need to comply include:
- An application for ‘prior informed consent’ (PIC), by which the authorities of the providing country approve access to and utilisation of genetic resources.
- Establishment of ‘mutually agreed terms’ (MAT) defining the conditions governing the use of the genetic resources and benefit sharing (including e.g. dissemination of research results, the publication or other sharing of research data, and any potential exploitation).
For direct access (i.e. using genetic resources obtained directly from the country of origin by the researcher).
- Using the ABS Clearing House, determine whether the access measures include requirements to obtain PIC and MAT for the genetic resource (e.g. China requires PIC and MAT while Japan does not currently have such requirements).
- If unsure, contact that country’s named ABS National Focal Point designated under the Protocol to confirm. (See the Cambridge guide for further information)
- If required, apply for PIC. This involves submitting the required information (which will vary) to the identified entry points and stakeholders of the provider country (e.g. may include the Competent National Authorities, local communities and different levels of government) and may be time consuming.
- If materials or knowledge associated with genetic materials are obtained from indigenous or local communities, it is best practice to negotiate mutually agreed terms for access even if this is not required in the national legislation.
- Check whether you need other permits (e.g. export control, access to protected areas etc.)
- After PIC is obtained, the University will negotiate MAT with the Competent National Authority.
- 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.
- The ABS Clearing House generates an internationally recognised certificate of compliance (IRCC).
For indirect access (i.e. the genetic resource is accessed from a third party e.g. collaborator, private/registered collection, botanical garden etc.)
- 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)
- Obtain PIC and MAT from the intermediary. This will likely be in the form of an IRCC, but may be in the form of equivalent information (see information on records below).
- Confirm that the transfer and your intended utilisation are covered by PIC and MAT conditions.
- If not, apply for new or modified PIC and MAT from the provider country.
You must comply with the terms of PIC and MAT throughout research. If this is not possible, the PIC and MAT must be renegotiated.
A declaration of due diligence declarations will be required at one of two checkpoints if you are using genetic resources covered by the Nagoya Protocol. If your project reaches either checkpoint, you must submit a due diligence declaration.
- Receipt of research grants to support the utilization of the genetic resource – the declaration is required after the receipt of the first instalment of funding but before the final project report;
- Reaching the final stages of product development (i.e. commercialisation) as a result of utilising the genetic resource;
On reaching either checkpoint:
- Complete the relevant template:
- Contact Research and Innovation Services who will assist in submitting the declaration to the Office of Product Safety and Standards.
You should provide copies of relevant information, including records of any agreement, to Research & Innovation Services for storage. The following need to be stored for 20 years following the end of the period of use, and transferred to any subsequent users:
a) The internationally recognised certificate of compliance (IRCC) issued by the country of origin
b) Equivalent ‘due diligence’ information, including:
- The date and place the genetic resources and any associated traditional knowledge were acquired;
- A description of the items, using unique identifiers where they are available;
- The source from which the items were directly obtained;
- Whether the items are subject to rights and obligations regarding access and benefit sharing, including subsequent applications and commercialisation; and
- Any decision made regarding the access (including access permits where applicable), and any mutually agreed terms, including benefit-sharing arrangements.
Under the EU regulation, retention of this information and transfer to subsequent users is a requirement for compliance.
a) You will need to ensure the provision of access is consistent with the original access and benefits-sharing arrangements, and provide information regarding these arrangements to subsequent users. You should provide:
- The IRCC or equivalent information
- Access permits and MAT, where applicable.
b) The information must be kept by the new holder and included in any subsequent transfers.
c) Keep records such of sharing / access