Summary
Researchers that use non-human genetic material that originates from overseas must comply with the Nagoya Protocol.
Before you collect, receive or use any non-human genetic material in research (grant funded or otherwise), you should:
- Use Part 1 of the checklist to determine if your research is in scope of the Nagoya Protocol
- Complete and submit Part 2 (recordkeeping requirement) or Part 3 of the checklist as relevant.
- As relevant, read the information in sections 1-3 below regarding the Nagoya Protocol obligations that may arise throughout a research project
1. What is the Nagoya Protocol? Do you need to comply?
The Nagoya Protocol is an international agreement covering the use of non-human genetic material from another country. It recognizes that every country has rights over the genetic resources that exist within its borders. The Nagoya Protocol aims to ensure the fair sharing of benefits arising from the use of genetic resources and local knowledge about those genetic resources.
The UK ABS Regulation implements the Nagoya Protocol in the UK. Researchers have a legal obligation to comply with the Nagoya Protocol where it applies to their research (see section 2). This requires due diligence and recordkeeping steps. An ABS permit, ABS specific contract and due diligence declaration may be required.
The Nagoya Protocol applies to non-human genetic material (plant, animal, microbial and other) that originate from overseas. This includes bred, wild and domesticated species, viruses and laboratory grown materials involving non-human genetic material. It also applies to traditional knowledge associated with genetic resources (aTK)
The Nagoya Protocol only applies to non-human genetic resources (including aTK) that originate from overseas if both conditions are fulfilled:
- The country is party to the Nagoya Protocol and has ABS measures relating to the genetic resource you wish to access and
- You will use the genetic resource for the purpose of ‘utilisation of genetic resources’
1.1 Relevance of Nagoya
The Nagoya Protocol applies to:
- Basic, academic or non-commercial research (as well as commercial research)
- non-human genetic resources originating from overseas whether they are obtained from:
- the country of origin;
- Outside the country of origin, for example, a botanical garden in the UK;
- non-wild sources such as zoos.
- Laboratory grown materials (in some cases)
The Nagoya Protocol does not apply to:
- Human genetic resources
- Genetic resources as traded commodities without (later) research and development
- Genetic resources that are governed by specialized international ABS instruments (such as the International Treaty on Plant Genetic Resources for Food and Agriculture)
- Genetic resources that originate from the UK or the USA (as neither country has ABS requirements that restrict access to GR originating from UK/USA*)
*note: a number of other countries also have free access to genetic resources if used in non-commercial/academic research. For further details, please check the ABS restrictions map.
1.2 Compliance
In most cases, researchers that use non-human genetic resources from overseas (excluding USA) must:
- complete basic checks to assess the relevance of the Nagoya Protocol (see Part 1 of the Checklist) and
- keep records of the decision that the Nagoya Protocol does not apply to their work.
In instances where the Nagoya Protocol applies to a non-human genetic resource, researchers who access and use such material are required to follow several steps to ensure that genetic resources and aTK have been or will be accessed in accordance with applicable ABS laws implemented by the provider country.
Please be aware that some countries (whether a Party or Non-Party to the Nagoya Protocol) may have their own ABS legislation, unrelated to the Nagoya Protocol, that governs the access and use of their genetic resources for research that should also be followed (ABS Law). For example, Digital Sequence Information (DSI) may be in-scope of a country’s domestic ABS measures even if the activities don’t fall within the scope of the UK ABS regulations. Similarly, taxonomy often falls within the scope of national ABS laws of provider countries but not under UK ABS regulations. You are obliged to follow the ABS Law of the provider country.
2. How do I know whether Nagoya Protocol (NP) or ABS Law applies to my research?
Use the checklist to determine the Nagoya Protocol requirements. For additional context, this section outlines the full ABS process. Please do not proceed beyond step 2 below before getting in touch with the research governance team who will be able to provide advice and assist with the completion of steps 3-6 where there are NP obligations.
Step 1. Assess the relevance of Nagoya Protocol (NP) for your intended research
- Who? Researchers who intend to obtain a non-human genetic resource that originates from another country
- Why? You have legal obligation to comply with any applicable ABS measures
- How? Complete Part 1 of the Checklist
- When? Complete this step as early as possible when planning a research project e.g. when preparing the grant proposal.
Step 2A If no NP requirements, keep appropriate records
- Who? Researchers that have obtained non-human GR and aTK from outside the UK for research
- Why? As evidence to show the assessment that the GR and/or aTK wasn’t within scope of the Nagoya Protocol or ABS Law. The UK regulator may inspect these records.
- How? Complete Part 2 of the Checklist. No further action is required. If unsure, proceed to step 2b below.
- When? You should create this record at the time you judged that there aren’t any NP obligations. You must maintain these records for 20 years after the end of use.
Step 2B If there are NP requirements, identify specific details of the obligations relating to the GR you intend to use.
- Who? Research governance team on behalf of and in consultation with the researchers intending to use the GR and/or aTK that has ABS requirements under the Nagoya Protocol.
- How? Researchers complete Part 3 of the Checklist. You can also check the ABS Clearing House or contact the provider country National Focal Point (NFP).
- When? As early as possible. Ideally when planning a research project e.g. when preparing the grant proposal.
Step 3. As relevant, submit an ABS application/request to the provider country to access the GR
- Who? Research governance team on behalf of and in consultation with the researchers intending to use the GR that has NP ABS obligations.
- When? As early as possible. Some countries’ ABS procedures may take several months or more to complete.
- How? The exact procedure differs from country-to-country. Researchers should contact the Research governance team for support and advice. Additional agreements may be required with the country authorities.
Step 4 Access and utilise the GR
- Who? Only researchers that have express permission from the country provider.
- When? After confirmation from the research governance team that the appropriate ABS approval is in place.
- How? In full compliance with the terms of the ABS approval/agreement.
Step 5. If required, submit a due diligence declaration to the UK government of GR that have NP obligations
- Who? Research governance team on behalf of researchers (note: this does not apply to researchers that have ABS obligations but not NP obligations).
- When? After the ABS approval has been obtained from the country.
- How? Researchers complete and provide the due diligence declaration to the Research governance team who will submit it to Defra (see section 3 below)
Step 6 If you wish to transfer GR and/or aTK governed by ABS Law/NP obligations to a third party/collaborator
- This may only be done if you have express permission from the country provider. Do not make any transfer unless it is permitted. See the transfer section below for more information.
If you are unclear about any step in this process, or need to consult with the Research Office, use the contacts details in the key contacts section.
3. Practical considerations and researcher obligations
Researchers using GR that originate from overseas need to know what, if any, specific ABS or NP obligations govern the material and its use, and must comply with these obligations.
3.1 The key obligations for researchers are:
- Seeking, keeping and transferring information about research material and ABS obligations. This requires making a thorough, best possible effort. This must be documented in a systematic way
- Submitting a due diligence declaration to the UK Competent authority (where required)
- Upon request, providing information to support checks by the UK regulator
3.2 There are several points throughout a research project when the Nagoya Protocol and ABS obligations are or may become relevant to researchers:
- Planning of research and applying for a research grant
- Being awarded a research grant and setting up relevant research contracts.
- Giving access to genetic resources to other researchers (including researchers within the University) or lodging material in collections biobanks or repositories
- Managing projects and awards (for example, submitting ABS applications, Defra due diligence declaration and reports to the provider country)
- Sharing your research, for example, publishing research findings in academic journals or publishing open data per terms of ABS contract
- Keeping records for 20 years after the end of utilization
- Patenting inventions or discoveries or seeking to commercialise technologies that encompass materials under NP or ABS regulations
3.3 Impact of Nagoya Protocol on a research project
You should establish whether the Nagoya Protocol or ABS obligations apply at the earliest point in your research project plans and ideally at pre-award stage. You can use Part 1 of the Checklist for Researchers.
Where it is likely that the Nagoya Protocol will apply, you should inform potential collaborators and/or funders that:
- access to the genetic resources may be subject to the relevant provider country’s laws,
- terms and conditions may be placed on access, export and utilisation by the researcher and any related collaborators, and
- timelines may be increased as a result.
You may find it helpful when planning your research to review section 2 and 3 in the ‘Building your ABS Strategy’ guidance developed by the German Nagoya Protocol hub.
Tips:
- If possible, identify a partner organisation in the country from which you wish to obtain genetic resources, as this will help to understand and comply with ABS requirements. Some countries require you to find a local collaborator.
- Allow sufficient time to obtain ABS approvals into your project plans. Depending on the country, this may take several months or longer. You should consider starting this process before project funding is approved; the timeframes in your grant application could be affected.
- Consider how much of your funding budget might be applied to financial contributions to access and benefit sharing and/or costs of obtaining access to genetic resources.
- Consider whether you would accept any possible access and benefit sharing provisions required under the country’s ABS and NP requirements. For example, you may need to provide access to your results, include them in publications, provide training, etc.
Ensure that any transfer of genetic resources and/or aTK expressly in accordance with requirements set out in the Prior Informed Consent (PIC) and the Mutually Agreed Terms (MAT) from the provider country. Do not make any transfers unless the PIC and MAT permit you to do so.
Ensure an appropriate research agreement is in place with the collaborator/third party, such as an MTA or collaboration agreement before you transfer the samples. Submit a research contract request to the research contracts team to request a research contract. You may also wish to discuss the transfer with research governance or SL&A team.
The provider country may:
- choose to include the collaborator/third party, who is receiving GR from you, as a party to the MAT
- permit you to transfer the GR and/or aTK to such collaborator/third party under the University’s own arrangements.
The research agreement should set out the conditions of use (if any) of the genetic resource by the collaborator/third party, in accordance and in compliance with the original PIC/MAT negotiated with the provider country.
Many countries issue an 'internationally recognised certificate of compliance (IRCC)'. If so, this document contains all the relevant information you need to share.
In case the IRCC does not exist, the following ‘equivalent information’ you should pass on:
- date and place of access to genetic resource and/or aTK
- description of the genetic resource
- the source from which the genetic resource was directly obtained (and any subsequent users)
- the presence or absence of rights and obligations related to access and benefiting sharing
- Mutually agreed terms (MAT), if available and if appropriate
- access permit, if applicable
It is important to maintain clear records of any collections or transactions made, to be available for inspection by the UK regulator. Records must also be retained for a period of 20 years following the end of use of the genetic resource.
If there are no NP obligations, you should:
- complete part 2 of the Checklist as a record of the required evidence and your actions that determined the genetic resource and/or aTK wasn’t within scope of the Nagoya Protocol and UK ABS regulation and
- submit Part 2 to the research governance team who will ensure this record is kept for 20 years.
For instance, should a current non-Nagoya Protocol country in the future join the Nagoya Protocol and/or or implement new ABS access measures relating to genetic resource you previously acquired, it is relevant to have documented the historical ABS position applying to your earlier access and use, particularly if you intend to access additional samples of that GR from that country.
If there are NP or ABS obligations, you (and the University) must obtain ABS approval and keep the following information:
• the date and place the genetic resources and associated traditional knowledge were acquired
• a description of the samples and any identifiers
• the source from which the items were obtained
• any terms and conditions governing access and benefit sharing (e.g. the PIC, MAT)
As explained above, you must transfer this information to any subsequent users (that have been expressly permitted by the providing country to obtain the GR from you). This includes transfer to other individuals in the University as well as external organizations.
It is the responsibility of the researcher, where the project has NP obligations, to submit a due diligence declaration to the UK regulator prior to the end of the project and to submit reports to the provider country per terms of the ABS agreement.
Users, of non-human genetic resources (or aTK) that originate from overseas, that fail to comply with applicable ABS laws and regulations or fail to utilise the material in accordance with the Mutually Agreed Terms could find themselves personally in breach of contract and liable for civil remedies either in the UK or the provider country.
The Office for Product Safety and Standards audits compliance with Nagoya Protocol and requires sight of all due diligence records to demonstrate compliance with the Nagoya Protocol, as required. Breach or non-compliance of Nagoya Protocol on audit could give rise to civil sanctions.
For researchers there are legal and professional implications arising from non-compliance with any of the following:
- the UK regulation,
- the ABS laws of the country providing material and
- your benefit-sharing agreement
Possible implications of non-compliance for your research include:
- Difficulties in publishing if you cannot confirm your work is Nagoya-compliant. For example, the journal Molecular Ecology requires authors to provide a statement of compliance with national ABS laws.
- Paper retraction due to non-compliance. For example, the authors of this retracted article on stag beetles from Borneo Island failed to follow the Sabah Biodiversity Enactment 2000.
- Biopiracy claims and damage to your reputation. For example, the high-profile quassia biopiracy allegation has been discussed in multiple articles e.g. see here and here
- Potential restrictions on future work in certain countries
- Research misconduct allegation
- Indefinite discontinuation of any further utilization of the material