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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:
Kew Gardens’ lead on the CBD, China Williams, has summarised the ABS framework as:
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:
If you are providing access to material that is subject to the Nagoya Protocol, you must:
Users of genetic resources accessed under the Nagoya Protocol are required to seek, keep, and transfer to subsequent users, information about the following:
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:
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.
Some local contacts:
Other (external) resources: