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Research Operations Office

 

The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the Convention on Biological Diversity (‘the Protocol’) is an international agreement to ensure the fair and equitable access and benefit sharing (ABS) in using genetic resources. It came into force on 12th October 2014.

There is a legal obligation for researchers to comply with the Protocol. Researchers planning fieldwork that may involve the collection of genetic material must consider this guidance before undertaking the field work.

 

 

1. What is the Nagoya Protocol?

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.

Researchers have a legal obligation to comply with the Nagoya Protocol. The Protocol only applies to genetic resources accessed: 1) from a country that is party to the Nagoya Protocol and that has ABS legislation and 2) for the purpose of ‘utilisation of genetic resources’ after 12th October 2014.

The protocol does not apply to:

  • Human genetic resources
  • Genetic resources already governed by specialised international instruments (e.g. the International Treaty on Plant Genetic Resources for Food and Agriculture)
  • Genetic resources as traded commodities

The Protocol applies both to those who obtain genetic resources directly from the country of origin and those who obtain them indirectly from third parties.

Researchers who use such material are required to follow several steps (see section 3 below & Checklist for Researchers) 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 provider country. These include: undertaking due diligence to ensure that all relevant permissions have been obtained, proper record keeping and the submission of due diligence declarations.

Researchers should refer to the Access and Benefit-sharing Clearing House (ABS Clearing House) which is an international web-based tool that facilitates the implementation of the Nagoya Protocol. ABS Clearing House shares relevant information about ABS (e.g. domestic regulatory ABS requirements and the national focal points and competent national authorities) and supports the monitoring of utilization of genetic resources. You may wish to use the ABSCH guide to help you navigate through the Clearing House website.

2. Regulation

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 was adopted by European legislation through Regulation (EU) No. 511/2014 and came into force on 12th October 2014. It was implemented into UK law through the Statutory Instrument No. 821 ‘The Nagoya Protocol (Compliance) Regulations 2015’. The legislation is implemented and enforced in the UK by the Office for Product Safety and Standards (OPS&S).

3. Compliance

Researchers who intend to access relevant genetic resources either directly from their country of origin or from third parties must exercise due diligence i.e. undertake a process to ascertain that any biological material accessed (or transferred) and used for research[1] meets legal requirements on ABS.

 

1. Determine whether the Nagoya Protocol will apply to the material. Please refer to the Checklist for Researchers, which provides a step by step guide on how to determine this. If you determine that the Protocol does not apply, skip to step 7 below. 

2. Identify information on the provider country. Use the Checklist for Researchers , referring to the ABS Clearing House website and the University’s  step-by-step guide to using the ABS Clearing House where necessary, to determine whether the provider country has ratified the Protocol and established measures to regulate the genetic resource you intend to use.

3. If required, undertake due diligence. The due diligence steps required will vary depending on how the genetic resource was accessed. The Checklist for Researchers summarises the steps detailed below.

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 ‘prior informed consent’ (PIC) and ‘mutually agreed terms’ (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 step-by-step guide for details on how identify the NFP).
  • 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, it is necessary for the University to 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)
  • Comply with these terms throughout research. If this is not possible, the PIC and MAT must be renegotiated.

For indirect access (i.e. the genetic resource is accessed from a third party e.g. collaborator, private/registered collection, botanical garden etc.):

  • Inquire about the best way to obtain the genetic resource for your project from the intermediary (this may vary depending on if the intermediary is a registered collection, collaborator, ex situ facility [2] 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 alternatively be in the form of equivalent information.[3]
  • Confirm that the transfer and your intended utilization are covered by PIC and MAT conditions.   
  • If not, apply for new or modified PIC and MAT from the provider country. 

4. Submit a Due Diligence Declaration. If you are using genetic resources that are covered by the Nagoya Protocol, it will be necessary to make a declaration of due diligence. Refer to the Checklist for Researchers for further information.  

5. Keep appropriate records[3].Due diligence records (i.e. IRCC or equivalent information3) must be stored for a minimum of 20 years after the end of utilization.  

6. Transfer (i.e. giving the genetic resource to a third party).

  • Transferring genetic resources must be in accordance with requirements set out in PIC and MAT.
  • The transfer should include:
    • the internationally recognised certificate of compliance (IRCC) associated with their access to the genetic resource (or equivalent information)
    • access permits and MAT, if applicable, and
  • The transferred information must be kept by the new holder and included in any subsequent transfers.

7. If you determine that your work is not within the scope of the Nagoya Protocol:

  • Please keep a record of your actions that determined the genetic resource was not within the scope as a ‘due diligence’ record.
  • No further action is required to ensure compliance with the Protocol or regulation.
  • Researchers should be aware, however, that some nations may have their own ABS legislation unrelated to the Nagoya Protocol and would need to be followed.  
[1] The EU’s guidance on the Protocol clarifies that ‘research’ should be defined as “the systematic investigation into and study of materials and sources in order to establish facts and reach new conclusions” and ‘research and development’ as “creative work undertaken on a systematic basis in order to increase the stock of knowledge, including knowledge of man, culture and society, and the use of the stock of knowledge to devise new applications”.
[2] If genetic resources accessed from an ex situ collection in the country of origin after 12th October 2014, they are in the scope regardless of when they were added to collection
[3] ‘Equivalent information’ should include the date and place of access to the genetic resource; the description of genetic resource, including unique identifiers where available; the source from which the genetic resource was directly obtained; the presence or absence of rights and obligations relating to access and benefit-sharing, including subsequent applications and commercialisation; access permits, where applicable; mutually agreed terms, including benefit-sharing arrangements, where applicable.
4. Key Terms

Genetic resources: Any material of plant, animal, microbial or other origin containing functional units of heredity, which is of actual or potential value, or derivatives.

Internationally recognised certificate of compliance (IRCC): A domestic access permit that has been made available to the Protocol's Clearing-House. All Parties with users in their jurisdiction must recognise such certificates as evidence of acquisition in accordance with applicable rule of the genetic resource covered.

Mutually Agreed terms (MAT): Agreement between two private parities under civil law contract; defining the conditions governing the use of genetic resources and benefit-sharing.

Prior Informed Consent (PIC): Approval by the authorities of the providing country of access to and utilization of genetic resources

Utilization of genetic resources: 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.

5. Contacts

Requests for advice regarding the Nagoya protocol can be made to Dr Rhys Morgan, Head of Policy, Integrity and Governance: rhys.morgan@admin.cam.ac.uk or researchintegrity@admin.cam.ac.uk