The Nagoya Protocol: Registering Collections of Genetic Resources in the UK

Jane Collins

Jane Collins is the Enforcement Team Leader for Access and Benefit Sharing at the Office for Product Safety and Standards (OPSS), part of the UK Government’s Department for Business, Energy and Industrial Strategy (BEIS).

 

The Convention on Biological Diversity and the Nagoya Protocol

In recognition of the value of biodiversity, the Convention on Biological Diversity (CBD) came into effect in 1993 with three main objectives: (1) to conserve biodiversity; (2) to ensure the sustainable use of biodiversity; and (3) to ensure the fair and equitable sharing of benefits arising from the utilisation of genetic resources. The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilisation, or ‘Nagoya Protocol’ for short, came into force in October 2014, creating a legal framework for the third objective’s effective implementation.

‘Genetic resources’ are defined in the CBD as ‘genetic material of actual or potential value’; in turn, ‘genetic material’ means ‘any material of plant, animal, microbial or other origin containing functional units of heredity’, but not including human genetic material. ‘Utilisation of genetic resources’ is defined in the Nagoya Protocol as ‘research and development (R&D) on the genetic and / or biochemical composition of genetic resources…’.[1] ‘Users’ of genetic resources are defined as ‘any natural or legal person that utilises genetic resources or traditional knowledge associated with genetic resources’.  Users may include the individual (e.g. researcher) utilising the genetic resource or the organisation (e.g. university, research institute, company etc) to which the individual is affiliated with and / or employed by. Alternatively, both may be jointly considered as the user and therefore hold joint responsibility for compliance with applicable ABS measures. The entity considered as the ‘user’ will depend on a case-by-case basis. 

 

The UK Access and Benefit Sharing Regulation

In the UK, compliance measures under the Nagoya Protocol are contained in the UK Access and Benefit Sharing (ABS) Regulation[2]. The Regulation requires users to exercise due diligence to ascertain that genetic resources and traditional knowledge associated with genetic resources which they utilise have been accessed in accordance with applicable ABS legislation or regulatory requirements, and that benefits are fairly and equitably shared upon mutually agreed terms, in accordance with any applicable legislation or regulatory requirements.

The UK ABS Regulation is triggered when a researcher accesses (after the 12^th October 2015) genetic resources from a provider country that is party to the Nagoya Protocol and has access legislation covering the genetic resources being utilised, that are not already governed by specialised international ABS instruments (e.g. the Pandemic Influenza Preparedness Framework and the International Treaty on Plant Genetic Resources for Food and Agriculture).

 

What are collections?

Collections are major suppliers of genetic resources and traditional knowledge associated with genetic resources. As such, collections are an important resource in biological sciences and collectively hold the potential for a wealth of new knowledge about the biology of millions of species worldwide. They can facilitate the access to genetic resources for research, saving researchers time and money compared to collecting genetic resources from the field.

 

What are registered collections?

There are two voluntary mechanisms that organisations can use to gain recognition for the ABS procedures that they’ve adopted and which support ABS compliance. These are ‘best practices’ and ‘registered collections’. Best practice can be thought of as the procedures, tools or mechanisms, developed and overseen by associations of users or other interested parties, which – when effectively implemented – help users of genetic resources to comply with the obligations of the UK ABS Regulation. A registered collection refers to a collection which has demonstrated the capacity to apply standardised procedures for exchanging samples of genetic resources (and related information), to supply genetic resources (and related information) to 3rd persons with documentation providing evidence that the genetic resources have been accessed in accordance with applicable ABS legislation.

There are currently no registered collections in the UK. However, we encourage UK collections to consider becoming registered. This can help to support compliance with the UK ABS Regulation. 

 

What is the role and benefit of registered collections?

Collections are well positioned to play an important role in the implementation of the Nagoya Protocol through the way that they engage with their users. They can assist their users in compliance by making them aware of their ABS obligations and also by providing genetic resources together with the relevant ABS documentation, thereby facilitating user compliance. The benefits to a collection holder of registering their collection include recognition, potential market advantage with a unique selling point and enhanced sales, and the demonstration of having established procedures in place which provides users with legal certainty. 

The benefits to users of accessing genetic resources from registered collections is that they are considered as having exercised due diligence (which is one of the user obligations under the UK ABS Regulation), thereby reducing the administrative burden placed on the user in terms of compliance. This has the potential to play an important role in supporting our research community in the UK.

 

What are the eligibility requirements to become a registered collection?

In order for a collection to be eligible for registration, the collection must be able to supply material which falls in-scope of ABS measures, or have the potential to receive in-scope material so that it can provide in-scope material in the future. A collection which is closed and does not have the option to hold in-scope material is not eligible to apply. In addition, a collection must be able to provide genetic resources together with the required documentation to prove due diligence. As such, a collection shall demonstrate its capacity to:

1. apply standardised procedures for exchanging samples of genetic resources and related information with other collections, and for supplying samples of genetic resources and related information to third persons for their utilisation in line with the CBD and the Nagoya Protocol;
2. supply genetic resources and related information to third persons for their utilisation only with documentation providing evidence that the genetic resources and the related information were accessed in accordance with applicable access and benefit-sharing legislation or regulatory requirements and, where relevant, mutually agreed terms;
3. keep records of all samples of genetic resources and related information supplied to third persons for their utilisation;
4. establish or use unique identifiers, where possible, for samples of genetic resources supplied to third persons; and
5. use appropriate tracking and monitoring tools for exchanging samples of genetic resources and related information with other collections.

 

How do we register a collection in the UK?

Since 01 January 2021, there is a new process in place for UK collections wishing to apply for registered status in the UK. To register a collection in the UK, you will need to download and complete the appropriate form the Office for Product Safety and Standards (OPSS) webpage and send it to DEFRA (abs@defra.gov.uk) for approval. The registration process will involve providing an indication of whether a holder is requesting to register a part of or an entire collection, and the type of genetic resources. Collection holders will also be required to supply documentation that can be used as evidence of the capacity of the collection, or relevant part of the collection, to comply with the UK ABS Regulation.

For more information on how to register a collection in the UK, take a look at the OPSS website: https://www.gov.uk/abs

 

UK Authorities

The Departments for Environment, Food and Rural Affairs (DEFRA) and Business, Energy and Industrial Strategy (BEIS) are responsible for implementing the Nagoya Protocol in the UK. The Office for Product Safety and Standards (OPSS), part of BEIS, acts as the Competent National Authority (CNA) and works directly with businesses, research organisations and other institutions to support understanding and compliance. For further information, please go to www.gov.uk/abs. If you have any questions or would like to discuss your specific case with us, please don’t hesitate to get in touch using the following address: OPSS.enquiries@beis.gov.uk    

 

[1] Convention on Biological Diversity. Text of the Nagoya Protocol https://www.cbd.int/abs/text/

[2] ‘UK ABS Regulation’ means legislation implementing the requirements of the Nagoya Protocol (on Access and Benefit Sharing (ABS)) in the UK, comprising The Nagoya Protocol (Compliance) (Amendment) Regulations 2015 (1691) and retained EU direct legislation (Regulation (EU) No 511/2014 of the European Parliament and of the Council of 16 April 2014 and Commission Implementing Regulation (EU) 2015/1866 of 13 October 2015), as amended by the Nagoya Protocol (Compliance) (Amendment) (EU Exit) Regulations 2018 (SI 2018/1393) and the Environment and Wildlife (Legislative Function) (EU Exit) Regulations 2019 (SI 2019/473)).