Data Science

Nagoya Protocol

What is the protocol?

The Nagoya Protocol enables the equitable sharing of genetic material, including associated traditional knowledge, and the benefits that arise from their use, whilst maintaining the origin countries' rights over the resources that exist within its borders.

The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilisation is an international framework that governs access to genetic materials, protecting the interests of all contractual parties involved in their use, and ensuring fair sharing of the benefits. It was established on 29 October 2010 in Japan and came into force in the UK in October 2014 after being ratified by the EU and has been agreed by 172 countries across the world.

The Nagoya Protocol covers any non-human genetic resources from animal, plant or microbes as well as addressing the traditional knowledge of genetic resources held by indigenous or local communities.

For more information or any guidance, please contact


Law and Regulations

All researchers in the UK are legally obliged to comply with the Nagoya Protocol under the EU Directive 511/2014 and The Nagoya Protocol Regulations 2015 under UK Law. The requirements are further reinforced by the BBSRC Guidance on Safeguarding Good Scientific Practice.

Failure to comply with this legislation could result in criminal and/or civil sanctions for the individual and the institution ranging from compliance notices to imprisonment; monetary penalties of up to £250,000 could be imposed.

The regulator in the UK is the Office for Product Safety and Standards (OPPS), appointed by DEFRA. OPPS are responsible for compliance with the Protocol and can carry out inspections, in which all researchers are required to comply with any audit requests.

It is the responsibility of the individual researcher accessing the resource to ensure that they and all members of their research team comply with the Protocol.

  • Does the protocol apply to your research?

    The Nagoya Protocol applies to both those who gain access to genetic resources either directly from the country of origin and those who gain access indirectly through a third party.

    There are four elements to consider when establishing if the genetic resource you are using falls under the Nagoya Protocol: Materials, Timeframe, Location, Activity.

    All four elements need to be within scope for the regulations to apply. If only 3 of the 4 elements apply to your research then it will not come under the Protocol.


    The Protocol applies to ALL genetic resources intended for research and development. There are a few exceptions which are listed below:


    The Protocol applies to resources (or traditional knowledge) which was accessed:

    • After 12 October 2014
    • From secondary/intermediary sources after 12 October 2014 requiring that they meet all other criteria

    Resources accessed before this date are not in scope even if they were not utilised until after that date.


    The Protocol applies only to countries that have ratified the protocol. You can find more information at the Access and Benefit=Sharing Clearing House which includes geographical areas that are governed by specific ratifying countries.

    If you are unsure, contact the relevant country’s ABS National Focus Point for confirmation.

    If the origin country has not ratified the Protocol, then they are not in scope, however they may still have their own legislation you have to comply with

    Genetic resources coming from areas beyond national jurisdiction (such as areas under the Antarctic Treaty System or the high seas) are not in scope.

    If you are accessing genetic resources from multiple different countries, then you must consider each providing country as a separate entity.

    If the resources are coming from a local indigenous community, it is best practice to establish mutually agreed terms for access with the community to avoid any issues.

    The UK does not regulate its own genetic resources so if you are exclusively working with resources originating from within the UK then no further action is needed.


    The definition of utilisation is ‘to conduct research and development on the genetic or biomechanical composition of genetic resources or their derivatives included through their application of biotechnology.’ This includes commercial and non-commercial research and may be basic or applied research.

    The Protocol applies to all genetic resources intended for research and development. There are a few exceptions:

    • The access material is used as testing/reference material for other test materials subjected to research and development
    • Genetic resource that already has a known activity/purpose and the research being conducted is in relation to that activity (e.g. supply of aloe vera for the use in cosmetics)
    • Material stored for describing phemotypic reference (botanical gardens) with no intention to be involved in research and development
    • Genetic resource that already has a known activity and no new research will be carried out with it (e.g. supply of yeast for the brewing).


    If your research is within scope then you will need to arrange certain agreements before starting your research using the genetic material. During your research you will be required to keep detailed records (specified in section below), and to submit Due Diligence declarations to DEFRA at specific points (see below).

  • How to implement the protocol

    Before using any genetic resource from abroad, please use the Nagoya Protocol Checklist for Researchers to determine if your research is within scope or not.

    Even if your research is not within scope, please keep a copy of the completed checklist within your study records.

    If you find your study is within scope, then you will need to conduct the following activity. Please note this will differ depending if you are accessing the resource direct from the country of origin or indirectly through a third party.

    Direct access

    1. Use the ABS Clearing House to determine the national laws and processes in the origin country which you need to follow, and also to identify useful contacts
    2. Make all reasonable efforts to obtain a Prior Informed Consent (PIC) if the ABS guidance states this is required.
      Explainer: A PIC is the permit obtained from the provider country that holds sovereign rights over the genetic resource that is being accessed. This permit outlines the use of the resource
    3. Negotiate a Mutually Agreed Terms (MAT) if the ABS guidance states this is required. Please contact the Research Contracts Team to assist with this (
      Explainer: A MAT is the contract between the provider and user which details terms of use, timeframes, transfer, benefit sharing terms and permissions around third parties.
    4. Confirm if any other permits are required (e.g. export controls or other access measures)
    5. Conduct and maintain records of due diligence, before during and after the transfer of resources.

    Indirect access

    1. Contact the third party and establish what agreements were in place when the origin country first provided the resource.
      • Where possible, obtain copies of the PIC and MAT used in the initial transfer of the resource. Ensure that your transfer complies with the relevant terms and conditions.
      • If you cannot comply with the terms and conditions from the original agreements, you will need to apply for new or modified versions.
      • Where PIC and MAT agreements were not used initially, you will need to obtain these for your transfer. You will also need to clarify why they were not used.
    2. Confirm if any other permits are required (e.g. export controls or other access measures)
    3. Conduct and maintain records of due diligence, before during and after the transfer of resources.
  • Due diligence checkpoints

    Researchers must submit a due diligence declaration at two specific checkpoints using the template available on the website

    1. At the point of receipt of funding in the form of a grant, for the utilisation of genetic resources
    2. At the final development stage of a product developed via the use of genetic resources where:
      1. Market approval or authorisation is sought
      2. Notification is required prior to placing on UK market
      3. Placing on the UK market for the first time where no approval, authorisation or notification is required
      4. The result of the use of genetic resource is being sold or transferred in any way outside of the UK in order for points a. b. or c. to happen
      5. The use of the product in the UK has ended and its outcome is sold or transferred in any way outside of the UK

    Researchers should complete the Due Diligence Declaration forms and send to Research Compliance ( to will review and will then submit to DEFRA on behalf of the researcher and institution.

  • Record keeping

    The lead researcher accessing the genetic resources must keep a record of all activities for 20 years following the end of the utilisation of the resource. This should also be shared and kept with the institution.

    The following documents should be maintained and recorded:

    • Copy of completed checklist
    • Screenshots from ABS Clearing House regarding country of origin
    • Any PIC/MAT agreements (if applicable)
    • Any Internationally Recognised Certificate of Compliance (IRCC) issued (if applicable)
    • Any communications with the National Focal Point of country of transfer (if applicable)
    • Communications with any third party (if applicable)
    • Due Diligence Declaration forms
    • Any other relevant information

    The lead researcher must share copies of all records with the institution by sending them to

    When a study is found to not be in scope, the lead researcher should still retain a copy of the completed checklist (along with any other documentation relevant to the Protocol) within the study records. 

Researchers wearing white coats using equipment in a laboratory

Key contacts

Research Compliance

Research Contracts Team

Enforcement Team at Office for Product Safety and Standards