Accessibility statement

Nagoya Protocol and the use of non-human genetic material

In certain cases, UK researchers who use non-human genetic material which originated outside of the UK, such as plants, animals, microbes, biomass and even food waste in research and development (“R&D”) are legally obliged to follow a number of steps in terms of permits, agreements, record-keeping and due diligence declarations. Research institutions can be subject to compliance inspections and the consequences of not complying with the law can be severe, including fines, reputational damage and in exceptional circumstances imprisonment.

Before using genetic material in any R&D (grant funded or otherwise) you should:

The Nagoya Protocol is an international agreement establishing a legal framework to govern access to genetic resources and/or associated traditional knowledge, and to ensure that benefits arising from the use of these resources are shared fairly.

The UK government has issued Guidance for those conducting R&D on genetic resources which we recommend you read. Researchers are required by law to conduct R&D in accordance with the Regulations in section 8 below. 

The legislation is enforced in the UK by the Office for Product Safety and Standards (OPSS). The requirements are reinforced in the BBSRC statement on Safeguarding Good Scientific Practice.

Key Contacts

Claire Walsh - Research Policy Officer (Compliance)
claire.walsh@york.ac.uk

Phil Wiles - Research Integrity and Compliance Manager
phil.wiles@york.ac.uk

 

1. Is my research in scope of the Nagoya Protocol and related Regulations?

To help you determine if your research is in scope please download, complete and retain a copy of the Nagoya Protocol - checklist for researchers (MS Word , 60kb) using the information below to guide you.

Your research will potentially be in scope of the Nagoya Protocol compliance requirements if the following applies:

  1. You intend to use a non-human genetic resource (i.e. any material of plant, animal, microbial or other origin [excluding human]) containing functional units of heredity [i.e. genes and DNA] and/ or asscoiated traditional knowledge ("Genetic Resource"); AND
  2. The Genetic Resource is not already covered by an international specialised instrument which has established access and benefit sharing (“ABS”) conditions e.g. ITPGRFA or the PIP Framework; AND
  3. The Genetic Resource is found within an area of national jurisdiction e.g. over which a sovereign state exercises rights (areas outside of national jurisdiction include the high seas or areas covered by the Antarctic Treaty System); AND
  4. The Genetic Resource was, or will be, accessed from the country of origin on or after 12 October 2014;
    AND
  5. The Genetic Resource will be utilised in the UK. “Utilised” means to conduct research and development on the genetic and/or biochemical composition of genetic gesources, including through the application of biotechnology. Genetic Resources which have been accessed for any use other than R&D are not in scope.

    Examples of situations which are not in scope include:
    • Supply/processing of raw materials where the properties are already known and no new R&D is carried out - e.g. supply of aloe vera for incorporation into cosmetics;
    • Genetic Resource as testing/reference tools - where the Genetic Resource itself is not the object of R&D but is used to confirm/verify the desired features of products which are undergoing R&D;
    • Handling/storing biological material and describing its phenotype (e.g. in a botanical collection) without undertaking R&D;
    • Using a Genetic Resource whose action is already known “as is” without undertaking R&D on the genetic resource itself - such as the use of yeast in brewing; and
    • Commodities traded for direct consumption or for use as ingredients in food and drink products (i.e. to be used only as a commodity) are not in scope. However, Genetic Resources which originally entered the UK as commodities but the intended use changes and R&D is undertaken on the Genetic Resource are in scope if they meet all other criteria. This would apply to nutraceuticals (e.g. dried leaf powder), food (e.g. oranges) and food waste (e.g. coffee grounds) if used for R&D.

If all the above criteria apply to your research it is potentially in scope of the Nagoya Protocol compliance requirements and you should consider the status of the provider country and whether the provider country has established any access measures (see sections 2 (a) and (b) below).

2(a) What is the status of the provider country?

You should identify the country from which the Genetic Resource originates, known as the provider country. If you are accessing Genetic Resources from different countries you must consider each provider country separately as different countries have different requirements.

If the provider country is a party to the Nagoya Protocol you should check if any access measures apply (see section 2(b) below).

If the provider country is not a party to the Nagoya Protocol then resources from that country are not in scope. However, the country may have domestic legislation relevant to access and benefit sharing which must still be complied with.

All parties to the Nagoya Protocol are required to make their legislative, administrative and policy measures on access and benefit sharing available on a searchable database called the ABS Clearing House. Refer to the ABS Clearing House to determine if the provider country is a party to the Nagoya Protocol.

2(b) Has the provider country established access measures in relation to the Genetic Resource or is it not clear?

You can use the ABS Clearing House to establish whether there are any relevant access measures as follows:

  1. Use the “search” mechanism to locate the country in the ABS Clearing House.
  2. Open the link for "INTERIM NATIONAL REPORTS ON THE IMPLEMENTATION OF THE NAGOYA PROTOCOL".
  3. Check the answer for question 12 "Does your country have fair and non-arbitrary rules and procedures on accessing genetic resources as provided in Article 6.3 (b)?"
  4. If the answer is “Yes” you should check the rest of the document and the ABS Clearing House entry for information about such procedures, including question 13 "Does your country provide information on how to apply for PIC as provided in Article 6.3(c)?"
  5. If the answer is “No” it is still good practice to check some of the other questions and answers to see if any access requirements are mentioned elsewhere, such as questions 7 and 8. Common access requirements include obtaining Prior Informed Consent ("PIC") and agreeing Mutually Agreed Terms ("MAT") from/with the provider country.

Some countries provide more information than others. If you are not sure about whether there are access measures in place or need more information about how to comply then you can contact the provider country’s ABS National Focal Point named on the ABS Clearing House. However, as a first step, it is useful to seek guidance from your overseas project collaborators and/or providers of the material. Each country has different requirements and so must be treated separately.

If the provider country is a party to the Nagoya Protocol and has established access measures which include the Genetic Resource in question, the resource is in scope if it meets all other criteria in section 1 above.

Please note that the UK does not regulate access to its own Genetic Resources. If you are exclusively working with Genetic Resources which originated in the UK, you do not need to take any further action.

If the provider country has not established access measures, or the measures do not include the Genetic Resource  in question, the activity is not in scope. The only exception to this is where the Genetic Resource (and particularly Traditional Knowledge associated with the Genetic Resource) come from an indigenous local community. In this case it is always best practice to mutually agree terms for access which take the views of the community into account even if it is not specifically required by national legislation.

Even if you determine the research is not in scope you should retain a record of your actions as a due diligence record to demonstrate this. For example, a copy of the completed Nagoya Protocol – Checklist for researchers, evidence the genetic resource is not in scope e.g. it was accessed before 12 October 2014, it is already covered by an instrumental specialised instrument which has established ABS conditions etc., or screen shots from the ABS Clearing House for the relevant provider country. Please refer to and complete question 5 (What records do I need to keep?) in the Nagoya Protocol - checklist for researchers (MS Word , 60kb) (see section 5 below).

A copy of the completed Nagoya Protocol – Checklist for Researchers and any supporting due diligence records should also be provided to Claire Walsh and Phil Wiles at the Research Strategy and Policy Office.

3. If my research is in scope how do I undertake due diligence?

If your research is in scope you should:

  • Notify the Research Strategy and Policy Office at an early stage.
  • Undertake due diligence. Due diligence involves gathering and using information in a systematic way to demonstrate that the necessary information related to a Genetic Resource is available. This will include your initial steps to determine if a Genetic Resource is in scope and any discussions you have had with a provider country’s National Focal Point.
  • Understand that the due diligence process can be time consuming. Please consider the additional time and administration that may be required to comply with the access requirements when planning your project.

See question 3 of the Nagoya Protocol - checklist for researchers (MS Word , 60kb) and follow the guidance below.

If the Genetic Resource will be provided directly from the country of origin

  1. Follow the country’s access measures.
  2. If you are unsure as to what access measures are in place, contact the country’s National Focal Point.
  3. If required, apply for and obtain Prior Informed Consent (“PIC”) as determined by the relevant access measures from the provider country’s relevant authority before the research activities commence. This may consist of a permit which outlines the permitted uses. You should comply with the terms of the PIC throughout the research. If circumstances change e.g. you need to undertake research activities not covered by the PIC or transfer the materials to a party not covered by the PIC, then you may need to apply for new PIC.
  4. If required, contact the Research and Knowledge Exchange Contracts team to negotiate Mutually Agreed Terms (“MAT”) as determined by the relevant access measures before research activities begin. This will be an agreement between the provider and the university to govern the use of the Genetic Resources and benefit sharing provisions e.g. terms of use, timeframes, permissions regarding transfer of material to third parties and benefit sharing arrangements.
  5. Confirm if any other permits are required e.g. export permits, access to certain areas, and, if so, obtain the relevant permit(s) from the provider country.
  6. Comply with any PIC, MAT and permits throughout the research. Retain copies for your records and provide copies to the Research Strategy and Policy Office.

If the Genetic Resource will be provided by a third party

  1. Contact the third party (e.g. collaborator, collection).
  2. Determine how the Genetic Resource will be obtained. 
  3. Confirm if PIC and MAT were obtained when the Genetic Resources was first provided by the provider country and, if so, obtain copies from the third party.
  4. If PIC and MAT were not obtained confirm why and obtain records confirming they were not required.
  5. If PIC and MAT are available ensure the transfer and use of the Genetic Resource complies with the relevant terms and conditions.
  6. If PIC and MAT are not available but will be required for your use, or any existing PIC or MAT do not cover the proposed transfer or use of the Genetic Resources by you, apply for PIC from, and contact the Research and Knowledge Exchange Contracts team to negotiate MAT with, the provider country’s relevant authority.
  7. Confirm if any other permits are required e.g. export permits, access to certain areas, and, if so, obtain the relevant permit(s) from the providers country.
  8. Comply with any PIC, MAT and permits throughout the research. Retain copies for your records and provide copies to the Research Strategy and Policy Office.

4. Is a due diligence declaration required?

There are two checkpoints which trigger the requirement for a due diligence declaration to be submitted by the user of the Genetic Resource:

  1. Checkpoint 1. At the stage of research funding in the form of a grant – after the first instalment of funding has been received and all the Genetic Resources that are utilised in the funded research have been obtained, but no later than at the time of the final report, or in absence of such report, at the project end.

  2. Checkpoint 2. At the stage of final development of a product – only once, at the first event from the list below for a product developed via the utilisation of the Genetic Resource:
  • Market approval or authorisation is sought for the product.
  • A ‘notification required prior to placing for the first time on the UK market’ is made for the product.
  • Placing the product on the UK market for the first time (where no prior market approval, authorisation or notification is required).
  • The product is sold or transferred in any other way to a natural or legal person in order for that person to carry out an activity listed in one of the bullet points above.
  • The utilisation in the UK has ended and the output of the utilisation is sold or transferred in any other way to a natural or legal person outside the UK.

The Office for Product Safety and Standards specifically states that any UK established recipient of research funding by way of a grant, whether from non-commercial or commercial sources, involving the utilisation of Genetic Resources must submit a due diligence declaration to Defra.

Users of Genetic Resources must also submit a due diligence declaration to Defra at the stage of final development of a product, developed from the utilisation of Genetic Resources.

If you determine a due diligence declaration is required you should complete  a due diligence declaration form available through the UK government’s Guidance for those conducting research and development on genetic resources under the heading “Process for submitting due diligence declarations, applying for best practice and registering a collection in the UK”.

Please then provide the completed due diligence declaration form to Claire Walsh and Phil Wiles in the Research Strategy and Policy Office who will assist you with the submission of the form to Defra on behalf of the university.

5. What records do I need to keep?

Due diligence records must be kept for 20 years after the end of utilisation. To assist with institutional record keeping please ensure you provide copies of your due diligence records to Claire Walsh and Phil Wiles in the Research Strategy and Policy Office.

If your research is in scope of the Nagoya Protocol you are required to seek, keep, and transfer to subsequent users, information about the following:

  • the date and place the Genetic Resources and/or associated traditional knowledge were acquired;
  • a description of the Genetic Resources, including unique identifiers where they are available;
  • the source from which the Genetic Resources was obtained;
  • any existing rights and obligations relating to access and benefit sharing; and
  • any permits or MATs. 

Please use question 5 (What records do I need to keep?) of the Nagoya Protocol - checklist for researchers (MS Word , 60kb) to assist you to determine which records should be maintained and provided to the Research Strategy and Policy Office.

Examples include:

  1. The completed Nagoya Protocol - Checklist for researchers.
  2. Evidence the Genetic Resource is not in scope e.g. it was accessed before 12 October 2014, it is already covered by an international specialised instrument which has established ABS conditions etc.
  3. Screen shots from the ABS Clearing House for the relevant provider country.
  4. Communications with the provider country’s National Focal Point.
  5. Communications with any third party providers e.g. collaborators, collections.
  6. Any IRCC or equivalent information (including the date and place of access of the Genetic Resource, a description of the Genetic Resource including unique identifiers where available, the source from which the Genetic Resource was directly obtained, any existing rights and obligations relating to access and benefit sharing, any permits or MATs (see below)). Please note this information must be maintained where applicable.
  7. Any PICs, MATs or other permits, including any application paperwork.
  8. Any records from third parties confirming why PICs, MATs or permits were not required.
  9. Any completed due diligence declaration form.

Even if you determine the research is not in scope you should retain a record of your actions as a due diligence record to demonstrate this, including a copy of the completed Nagoya Protocol – Checklist for researchers.

6. Can I transfer the Genetic Resource to another party?

Do not transfer Genetic Resources to any third party unless your PIC and MAT give you permission to do so. Users are required to seek, keep and transfer to subsequent users key information either by: (a) referring to an Internationally Recognised Certificate of Compliance (IRCC) associated with their access to the Genetic Resource; or (b) seeking and acquiring the necessary equivalent information.

The key information users must seek, keep and transfer to subsequent users if they are permitted to do so is:

  • date and place of access to the Genetic Resource.
  • a description of the Genetic Resource.
  • the source from which the genetic resource was directly obtained.
  • any existing rights and obligations relating to access and benefit sharing.
  • access permits, if applicable.
  • mutually agreed terms, if applicable.

7. Nagoya Protocol and Worktribe

To assist the university with its compliance obligations you will be required to answer the following risk management question(s) regarding the use of genetic materials and the Nagoya Protocol when setting up a project or using the Contracts Module in Worktribe:

  • Is this a project that involves the use of non-human genetic materials or traditional knowledge associated with genetic materials? Genetic materials means any material of plant, animal, microbial or other origin [excluding human] containing functional units of heredity [i.e. genes and DNA].

  • If yes, do the genetic materials or traditional knowledge originate (either directly or through a third party) from a country which is a party to the Nagoya Protocol? Please use the ABS Clearing House to establish if a country is a party to the Nagoya Protocol. Further information can be found on the university's Nagoya Protocol webpage.

If you require assistance to answer the above questions or answer “yes” to both questions:

  • Review the information on the Nagoya Protocol webpage above to determine what steps you need to take; and
  • contact Claire Walsh and Phil Wiles in the Research Strategy and Policy Office.

The information on this web page was last updated on 10th February 2021.