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The Nagoya Protocol is an international agreement that aims to ensure the fair and equitable sharing of benefits arising from the use of genetic resources and associated traditional knowledge.
Overview
Each country has rights over the genetic resources that exist within that country such as animals, plants, and organisms as well as the traditional knowledge associated with them. Access and Benefit-sharing (ABS) principles aim to reduce the inequalities between those providing genetic resources and those that use them, and many countries have established specific ABS legislation.
‘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 is an international agreement which aims at sharing the benefits arising from the utilization of genetic resources in a fair and equitable way.’*
There is a legal obligation for researchers to comply with the Nagoya Protocol. UCL researchers planning work that may involve the import or export of genetic material must consider the guidance below before commencing their work.
- Definitions
- Genetic material means 'any material of plant, animal, microbial or other origin containing functional units of heredity'.
- Genetic resources means 'genetic material of actual or potential value'
- Traditional knowledge associated with genetic resources means 'traditional knowledge held by an indigenous or local community that is relevant for the utilisation of genetic resources and that is as such described in the mutually agreed terms applying to the utilisation of genetic resources'
- User means 'a natural or legal person that utilises genetic resources or traditional knowledge associated with genetic resources'
- Access means 'the acquisition of genetic resources or of traditional knowledge associated with genetic resources in a Party to the Nagoya Protocol'
- Utilisation of genetic resources means 'to conduct research and development on the genetic and/or biochemical composition of genetic resources, including through the application of biotechnology as defined in Article 2 of the Convention'.
Watch Professor Michael Heinrich, Professor in the UCL School of Pharmacy and former Co-Chair of the UCL Research Ethics Committee with many years of research experience, share a brief message about the importance of Access and Benefit Sharing and the Nagoya Protocol.
What is the Nagoya Protocol?
The Nagoya Protocol focusses on the equitable sharing of the benefits that arise from the use of genetic resources. It came into force on 12 October 2015 and has been implemented into UK law through European Regulation (EU) No. 511/2014 and the Statutory Instrument '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).
From 12 October 2015, anyone who wishes to access genetic resources and/or the traditional knowledge associated with those resources must comply with this regulation. The Nagoya Protocol applies both to those who obtain genetic resources directly from the country of origin, as well as those who obtain them indirectly from third parties.
What is in scope of the legislation
- Research into the genetic and/or biochemical composition of the organism, e.g.: research and/or development in relation to gene function and inheritable traits
- Research relevant to the potential value of the organism, e.g.: research involving a genetic resource leading to the isolation of a biochemical compound used as a new ingredient incorporated into a pharmaceutical product; genetic modification - the creation of a genetically modified organism containing a gene from another species.
What is not in scope
- Genetic resources for which access and benefit-sharing is governed by specialised international instruments (such as the International Treaty on Plant Genetic Resources for Food and Agriculture)
- Human genetic resources. However, the legislation might apply to genetic resources derived from human microbiota
- Descriptive research, e.g., describing a species/taxonomy
- Ecological research, e.g., research into how an organism interacts with its environment
- Maintenance and management of a collection for conservation purposes
- Genetic resources as testing/reference tools (when the specific genetic resource is not the subject of the research).
For more detailed guidance, clarifications, and examples see:
- Guidance on the UK Access and Benefit Sharing Regulations (pdf)
- Annex II of EU guidance document on the scope of application and core obligations of Regulation (EU) No 511/2014
Consequences of non-compliance
Compliance with the Nagoya Protocol is a legal requirement. Potential consequences of non-compliance include:
- Legal implications: depending on the country of jurisdiction this can include confiscation of the material, financial penalties, or even imprisonment. Please note that sanctions can be imposed both by the UK government and by the country providing the genetic resources
- Research-related implications: these could include loss of reputation, prohibition of further work, not being able to publish, or the need to retract your publications. In addition, a failure to meet relevant legal requirements falls within UCL’s definition of research misconduct under the UCL Procedure for investigating and resolving allegation of misconduct in academic research (2021).
How do I comply?
You must exercise due diligence, keep appropriate records, and obtain all necessary permissions to show that relevant country requirements have been met. You may be required to submit a due diligence declaration to the Department for Environment, Food & Rural Affairs (Defra) - see below for more details.
On the Access and Benefit-Sharing Clearing-House website you will find details of which countries are party to the Nagoya Protocol, meaning those that have implemented it into their own legislation and therefore giving users a route by which to seek access to genetic resources.
It is also important to check the legislation of the country from where the resources/knowledge originate (provider country) as it may have additional rules regarding access.
If you require advice on whether the Nagoya Protocol applies to your work, complete and submit our Nagoya Protocol enquiry form.
Bitesize training
For an overview of the Nagoya Protocol and the support available at UCL, watch our Bitesize Training video.
Compliance: step-by-step guidance
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 meets the legal requirements of the Nagoya Protocol.
The below guidance has been adapted with permission from the University of Cambridge.
The Nagoya Protocol: checklist for researchers
- 1. With support from the University 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.
Where you consider that your work is or may be within the scope of the Nagoya Protocol further to Sections 1 and 2 of the Checklist, please contact the Compliance and Assurance team (ris.complianceandassurance@ucl.ac.uk) who will support you with the further steps outlined in the Checklist and below, as required.
For more detailed guidance and examples, see:
If you determine that the Protocol does not apply, skip to step 7 below.
- 2. Identify information on the provider country
Determine whether the provider country has ratified the Nagoya Protocol and established measures to regulate the genetic resource you intend to use. Use the
and refer to the ABS Clearing House website and the University of Cambridge guide to using the ABS Clearing House where necessary.
- 3. Undertake due diligence
The due diligence steps required will vary depending on how the genetic resource was accessed. See the
for more details.
- 4. Submit a due diligence declaration
If you are using genetic resources that are covered by the Nagoya Protocol, a declaration of due diligence will be required at two checkpoints:
- Receipt of research grants to support the utilization of the genetic resource – the declaration is required after the receipt of the first installment of funding but before the final project report
- Reaching the final stages of product development (i.e., commercialisation) as a result of utilising the genetic resource
The Compliance and Assurance team in Research and Innovation Services will work with you to complete the due diligence declaration form and will submit the form to Defra.
- 5. Keep appropriate records
Due diligence records (i.e., internationally-recognised certificate of compliance (IRCC) or equivalent information) must be stored for a minimum of 20 years after the end of utilization. Researchers should ensure they retain such records accordingly.
Note: If there is a new utilisation/transfer of the resource concerned during that time then the 20-year period starts again.
- 6. Transfer (i.e., giving the genetic resource to a third party)
Any transfer of genetic resources must be made in accordance with requirements set out in the Prior Informed Consent (PIC) and Mutually Agreed Terms (MAT).
The transfer should include:
- The IRCC associated with access to the genetic resource (or equivalent information)
- Access permits and the MAT, if applicable.
The transferred information and documentation must be kept by the new holder and included in any subsequent transfers of the resource.
- 7. If you determine that your work is not within the scope of the Nagoya Protocol
- Please keep a record of the actions you took to determine that the genetic resource was not within the scope as a ‘due diligence’ record. For more information and examples of what can be used as evidence that the project is out of scope, see Defra's Guidance on the UK Access and Benefit Sharing Regulations (pdf)
- No further action is required to ensure compliance with the Nagoya Protocol
- Researchers should be aware, however, that some nations may have their own ABS legislation unrelated to the Nagoya Protocol that would need to be complied with
- Even if there is no relevant national legislation, it is best practice to negotiate and agree how any potential benefits that might arise (monetary or non-monetary) from the use of genetic resources or associated knowledge will be shared. This should be done before the transfer of any material or associated knowledge to researchers, and on terms that are co-developed with resource custodians or knowledge holders. For more information, visit the Research Integrity ABS webpage.
Further advice and support
For general questions and advice regarding the Nagoya Protocol please contact our Compliance and Assurance team at ris.complianceandassurance@ucl.ac.uk.