Access and benefit sharing of genetic resources: compliance and guidance
- Regulatory Delivery, Department for Business, Energy & Industrial Strategy, and Department for Environment, Food & Rural Affairs
- Part of:
- Business regulation
- First published:
- 2 June 2015
Complying with the Nagoya Protocol on access and benefit sharing of genetic resources for users of genetic resources.
The Nagoya Protocol was adopted in 2010 and recognises the rights of countries to regulate access and utilization of their genetic resources through national legislation.
Benefits arising from research and development activities involving genetic resources should be shared with the providing country in either monetary or non-monetary form.
Users of genetic resources and / or associated traditional knowledge which fall within scope of relevant national legislation must seek prior informed consent and establish mutually agreed terms prior to utilisation.
The legislation may affect a variety of sectors in the UK including:
- food and beverage
- cosmetic and personal care
- animal breeding
- plant breeding
- bio-control and academia
How to comply with the Nagoya Protocol
A company wishing to access a genetic resource from a country that is a party to the agreement must exercise due diligence. In practice, this entails submitting an application to the relevant Competent Authority. Depending on the national measures that apply, you may need to obtain prior informed consent to access the genetic resource and / or assent to mutually agreed terms for undertaking research and development. These will include provisions for benefit sharing, possibly in relation to the traditional knowledge associated with genetic resources.
The process of due diligence must be exercised by all users of genetic resources based in the EU. In addition, users of genetic resources may be required to submit a due diligence declaration at one or two points within the research and development programme. The Implementing Regulation (see below) provides templates for due diligence declarations, both at the stage of research funding and at the stage of final development of a product.
Where the research is undertaken in the UK, due diligence declarations should be submitted to Regulatory Delivery at the following address: email@example.com.
For further guidance on the completion and / or submission of a due diligence declaration, please contact Regulatory Delivery.
Clearing house mechanism
Parties to the Nagoya Protocol are establishing national legislation to provide legal clarity for users and providers of genetic resources and associated traditional knowledge. Information on the parties to the protocol and relevant legislation can be found on the Access and Benefit-sharing Clearing-house (ABSCH). The ABSCH is a platform for exchanging information on Access and Benefit Sharing and a key tool for facilitating the implementation of 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.
Commission Implementing Regulation (EU) 2015/1866 lays down detailed rules for the implementation of Regulation (EU) No 511/2014 as regards the register of collections, monitoring user compliance and best practices.
The European Commission has developed a guidance document on the scope of application and core obligations of Regulation (EU) No 511/2014 on the compliance measures for users from the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilisation in the Union.
If you have a specific enquiry about compliance with the regulations, please use the contact details on our enforcement services page.
Subscribe to our free email alert service to keep up to date on the latest developments concerning the legislation that Regulatory Delivery enforces.
Published: 2 June 2015