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.
Please note that even if a country is not a party to the Nagoya Protocol it may have domestic legislation relevant to access and benefit sharing, which must still be complied with.
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 , 61kb) using the information below to guide you.
Your research will potentially be in scope of the Nagoya Protocol compliance requirements if the following applies:
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).
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.
You can use the ABS Clearing House to establish whether there are any relevant access measures as follows:
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 , 61kb) (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 Policy, Integrity and Performance Team.
If your research is in scope you should:
See question 3 of the Nagoya Protocol - checklist for researchers (MS Word , 61kb) and follow the guidance below.
If the Genetic Resource will be provided directly from the country of origin
If the Genetic Resource will be provided by a third party
There are two checkpoints which trigger the requirement for a due diligence declaration to be submitted by the user of the Genetic Resource:
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 Policy, Integrity and Performance Team who will assist you with the submission of the form to Defra on behalf of the university.
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 Policy, Integrity and Performance Team.
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:
Please use question 5 (What records do I need to keep?) of the Nagoya Protocol - checklist for researchers (MS Word , 61kb) to assist you to determine which records should be maintained and provided to the Policy, Integrity and Performance Team.
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.
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:
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:
If you require assistance to answer the above questions or answer “yes” to both questions:
The information on this web page was last updated on 10th February 2021.