Information on legal requirements for researchers
Individual academics and researchers in the University have a legal obligation to comply with the Nagoya Protocol.
The regulation on compliance measures for users from the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization (EU) 511/2014 is part of UK law under The Nagoya Protocol (Compliance) Regulations 2015.
The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization (the ‘ABS’ Protocol) is an international agreement that implements the access and benefit-sharing obligations of the Convention on Biological Diversity (CBD).
Genetic resources in this context include any material of plant, animal, microbial or other origin containing functional units of heredity which is of actual or potential value, or derivatives.
Researchers who source or use such material are required to 'exercise diligence' to ensure that genetic resources and traditional knowledge associated with those resources have been accessed in accordance with applicable access and benefit sharing laws implemented by the source country.
Traditional knowledge refers to knowledge, know-how and practice of indigenous and local communities relevant for the utilisation of the genetic resources accessed under the protocol.
The protocol does not apply to:
- human genetic resources
- genetic resources covered by specialised ABS treaties that are supportive of the CBD (for instance, the International Treaty on Plant Genetic Resources for Food and Agriculture)
Kew Gardens’ lead on the CBD, China Williams, has summarised the ABS framework as:
- follow national laws
- get prior informed consent from the provider
- mutually agree terms with the provider
- share benefits fairly and equitably
This aim is to provide the incentive for conservation and sustainable use.
If you are accessing material that is subject to the Nagoya Protocol, you must:
- Use the Access and Benefit-Sharing Clearing-House (ABSCH) to identify the relevant national laws, procedures and contact points in the countries from which you wish to source the material.
- Make all reasonable efforts to gain prior, explicit informed consent and agree the terms and conditions of access. This should deal with the dissemination of research results, the publication or other sharing of research data, and any potential exploitation.
- Keep records related to (1) and (2) for 20 years. These records may be inspected by the regulator.
If you are providing access to material that is subject to the Nagoya Protocol, you must:
- Ensure such action is consistent with the original access and benefits-sharing arrangements
- Keep records of such sharing/access for 20 years. These records may be inspected by the regulator.
Users of genetic resources accessed under the Nagoya Protocol are required to seek, keep, and transfer to subsequent users, information about the following:
- the date and place the genetic resources and associated traditional knowledge were acquired
- a description of the items acquired, using unique identifiers where they are available
- the source from which the items were obtained
- whether the items are subject to rights and obligations regarding access and benefit sharing
- any decision made regarding the access, as well as the mutually agreed terms of access.
- required to maintain such information for a period of 20 years following the end of the period of use
- mandated to declare at identified points that they have complied with their due diligence obligations
- subject to audit/inspection by the regulatory authorities
There are several likely touch points where researchers will come into contact with questions or requirements related to the Nagoya Protocol on access and benefits-sharing (ABS). These include:
- applying for a research grant (eg you may be asked to describe ABS considerations or have agreements in place)
- being awarded a research grant (eg you may be required to demonstrate ABS approvals compliance at the outset or within a specified period)
- applying to your head of department for permission to undertake fieldwork
- seeking project approval (eg in the University’s Department of Plant Sciences)
- going to obtain or purchase genetic resources
- seeking to lodge material in collections (at Oxford or museums, laboratories, libraries, gardens or herbaria in other locations) (eg you will almost certainly be asked to show ABS compliance and records)
- seeking to provide or give access to genetic resources to: other researchers, other units in the University, or external organisations
- seeking to patent certain discoveries (where it is suspected that genetic resources from another country have been used).
As the RHS noted, for these patents to progress applicants will need to prove that agreements relating to the collection and use of the genetic resources are in place with the host country. Alternatively, they will need to show that they have carried out 'due diligence' to check that the material falls outside of the scope of the legislation).
- seeking to sell or in other ways commercialise resources or products based on genetic resources.
This is a particular focus under the protocol to ensure that providers of material and local knowledge (including indigenous and local communities) receive a fair and equitable share of benefits.
The Nagoya Protocol was adopted by European legislation and entered into force in the UK on 22 May 2016. The responsible UK agency, Defra, focused initially on working with industry, especially pharmaceuticals, beauty, food and beverage, seed and plant biotechnology.
Defra and the Regulator (based in BEIS) are planning to develop information and education material for academic researchers. Oxford is part of a network of universities sharing experiences and liaising with the government agencies, and is in particularly close contact with the Research Strategy Office at the University of Cambridge.
There is no UK-mandated ‘legal template’ for the informed consent and access agreements under the Nagoya Protocol. Defra anticipates that researchers in universities and other public bodies will act in good faith and keep records of relevant discussions and agreements.
The University’s Reference Group on the Nagoya Protocol does not wish to proscribe a single form for such records.
The regulator in the UK, Regulatory Delivery, will carry out checks on user compliance.
The checks will be conducted through a risk-based approach. Additional checks will be conducted when a competent authority is in possession of relevant information concerning a user's non-compliance.
Where a user has judged genetic resources (or associated traditional knowledge) to be out of scope and therefore not requiring compliance, the authorities will ask for justification of why it is thought to be out of scope.
Regulatory Delivery will have the power to impose compliance notices and variable monetary penalties. Non-compliance will normally be dealt with through civil sanctions, although Regulatory Delivery will be able to pursue criminal sanctions in serious cases.
Members of the University Reference Group on the Nagoya Protocol
- Darren Mann – Oxford University Museum of Natural History
- Simon Hiscock – Oxford Botanic Garden
- Beth Greenhough – School of Geography and the Environment
- Owen Lewis – Department of Zoology
- Andrew Gosler – Department of Zoology
- Greger Larson – PaleoBARN (Palaeogenomics and Bioarchaeology Research Network)
- Stephen Harris – Plant Sciences
- Kathryn Dally – Research Services
Other (external) resources
- YABS simply explained (YouTube)
- About the Nagoya Protocol (Convention on Biological Diversity)
- The ABS Capacity Development Initiative
- Learning note: the Nagoya Protocol (Darwin Initiative)
- Information about the Nagoya Protocol (EFPIA)
- FAQs on the Nagoya Protocol (Union for Ethical Biotrade)
- United Kingdom of Great Britain and Northern Ireland – National Focal Points on the Conservation of Biological Diversity