The Nagoya Protocol and Access and Benefit Sharing ('ABS')
At Queen Mary University of London, research involving genetic resources contributes to scientific discovery, innovation and global collaboration. When research involves genetic resources or associated traditional knowledge obtained from other countries, researchers may have legal obligations under the Nagoya Protocol and the UK's Access and Benefit Sharing (ABS) Regulations.
The Nagoya Protocol is an international agreement that promotes the fair and equitable sharing of benefits arising from the use of genetic resources. It recognises the rights of countries over their genetic resources and helps ensure that research is undertaken legally, ethically and transparently.
Most research undertaken at QMUL is unlikely to fall within the scope of the Nagoya Protocol. However, researchers working with overseas non-human genetic resources should consider whether the requirements apply and maintain records to demonstrate that genetic resources have been accessed in accordance with the laws of the provider country.
The Research Security Team is here to support you throughout this process.
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Please contact the Research Security team at: |
What is the Nagoya Protocol?
The Nagoya Protocol is an international agreement under the Convention on Biological Diversity. In the UK, it is implemented through the Access and Benefit Sharing (ABS) Regulations.
The Protocol applies to research and development involving certain non-human genetic resources and associated traditional knowledge obtained from countries that are Parties to the Nagoya Protocol and have implemented Access and Benefit Sharing legislation. Human genetic resources are not covered.
Genetic resources may include:
- plants
- animals
- microorganisms
- fungi
- environmental samples containing genetic material
- associated traditional knowledge relating to genetic resources.
The Protocol may apply where researchers use genetic resources accessed from overseas for research and development.
Most research projects will not require additional action. However, some projects require due diligence before research begins.
Why the Nagoya Protocol matters?
Researchers and universities have a legal responsibility to comply with the UK's Access and Benefit Sharing Regulations where they apply.
Failure to comply may result in:
- delays to research
- inability to demonstrate legal access to genetic resources
- regulatory enforcement action
- reputational damage to researchers and the University
- restrictions on future research collaborations
- difficulties publishing or commercialising research.
Considering Nagoya requirements at an early stage helps avoid these risks while supporting ethical and responsible international research.
The Protocol also helps to:
- promote fair and equitable benefit sharing
- support biodiversity conservation
- encourage responsible international research partnerships
- recognise the rights of countries providing genetic resources
- strengthen transparency throughout the research lifecycle.
Your responsibilities
Every researcher should consider whether the Nagoya Protocol may apply before obtaining or using non-human genetic resources from outside the UK.
This includes:
- identifying whether genetic resources originate from another country
- considering whether the provider country has Access and Benefit Sharing legislation
- obtaining any necessary permissions before accessing genetic resources
- keeping appropriate records demonstrating due diligence
- engaging with the University's due diligence process where required
- seeking advice from the Research Security Team if unsure.
If you are unsure whether your research falls within the scope of the Nagoya Protocol, contact the Research Security Team before beginning your research.
When the Nagoya Protocol may apply
The Protocol should be considered whenever research involves:
- Overseas genetic resources: Using plant, animal, microbial or other non-human genetic material obtained from another country.
- Associated traditional knowledge: Research using traditional knowledge associated with genetic resources.
- International fieldwork: Collecting biological samples during research undertaken overseas.
- Research collaborations: Working with international partners who provide access to genetic resources.
- Commercialisation: Research involving genetic resources that may lead to patents, products or commercial applications.
- Externally funded research: Projects involving genetic resources where a due diligence declaration may be required under the UK ABS Regulations.
Research involving Genetic Resources
Many researchers routinely work with biological materials that fall outside the scope of the Nagoya Protocol.
Where the Protocol does apply, researchers must demonstrate that genetic resources were accessed legally and that any applicable provider country requirements have been followed.
Researchers may need to obtain:
- Prior Informed Consent (PIC)
- Mutually Agreed Terms (MAT)
- evidence that due diligence has been completed
- supporting documentation demonstrating compliance with the provider country's legislation.
Due diligence records should be retained in accordance with UK regulatory requirements.
Early discussion with the Research Security Team helps ensure appropriate advice is provided without creating unnecessary barriers to research.
Does the Nagoya Protocol apply to my research?
Use the checklist below before starting research involving non-human genetic resources.
| Nagoya Protocol Checklist |
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Step 1 – Is your material within scope? Is your research using:
If No, the Nagoya Protocol is unlikely to apply. If Yes, continue to Step 2.
Step 2 – Where did the material originate? Was the genetic resource obtained from a country outside the UK? If No, the Nagoya Protocol is unlikely to apply. If Yes, continue to Step 3.
Step 3 – Does the provider country have Access and Benefit Sharing legislation? Check whether the provider country:
Researchers can check this using the ABS Clearing-House. If No, UK Nagoya obligations are unlikely to apply, although local legislation may still need to be followed. If Yes, continue to Step 4.
Step 4 – When was the material accessed? Will the genetic resource be accessed on or after 12 October 2015? If No, UK ABS obligations do not apply. If Yes, continue to Step 5.
Step 5 – How will the material be used? Will the material be used for research and development on its genetic and/or biochemical composition? Examples include:
If No, the Protocol is unlikely to apply. If Yes, continue to Step 6.
Step 6 – Will the research be undertaken in the UK? If No, seek advice from the relevant institution. If Yes, your research is likely to fall within the scope of the Nagoya Protocol. Please contact the Research Security Team before obtaining or importing the material. The team will advise on due diligence requirements and any permissions that must be obtained before research begins. |
What happens next?
If you answered Yes to all six steps
You should:
- Before research begins, researchers should contact the Research Security Team and ensure any applicable provider-country's requirements have been metobtain any required Prior Informed Consent (PIC)
- establish Mutually Agreed Terms (MAT) where required
- retain evidence demonstrating due diligence
- comply with any UK reporting requirements
- retain records for at least 20 years after the end of utilisation.
If you answered No to any step
Your research is unlikely to fall within the scope of the UK's Access and Benefit Sharing Regulations.
However, you should keep a record of how this decision was reached, as this may be requested during regulatory inspections. Some countries also have national ABS legislation that applies even where the UK Regulations do not.
If you are unsure whether the Nagoya Protocol or the UK Access and Benefit Sharing Regulations apply to your research, contact the Research Security team for advice before proceeding.
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Please contact the Research Security team at: |