Guidance

Regulations: The Nagoya Protocol on access and benefit sharing (ABS)

Guidance for those conducting research and development on genetic resources.

Overview

The Nagoya Protocol entered into force in October 2014. It provides a framework for the effective implementation of one of the three objectives of the Convention on Biological Diversity (CBD): the fair and equitable sharing of benefits arising out of the utilisation of genetic resources. It recognises that benefits derived by users of genetic resources should be shared with those who provide them, with the ultimate objective being the conservation and sustainable use of biodiversity.

Users of genetic resources – those conducting research and development – are required to exercise due diligence to demonstrate that genetic resources and / or associated traditional knowledge (aTK) are accessed and utilised in accordance with applicable legislation of the providing country.

The regulations in force in the UK are:

  • The Nagoya Protocol (Compliance) Regulations 2015 (UK Statutory Instrument, No. 821)
  • Regulation (EU) No. 511/2014 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 Utilisation in the Union
  • Implementing Regulation (EU) 2015/1866 laying down the detailed rules for the implementation of Regulation (EU) 511/2014 as regards the register of collections, monitoring user compliance and best practices

The legislation is implemented and enforced in the UK by the Office for Product Safety and Standards (Safety & Standards).

Scope of the legislation

The regulations apply when research and development is conducted on genetic resources and / or aTK. A genetic resource is any plant, animal, microbial or material of other origin which contains functional units of heredity and is of actual or potential value.

Human genetic resources are not covered by the Nagoya Protocol.

A variety of sectors conduct activities that are in scope of the regulations in the UK, which apply to both commercial and non-commercial research. Those sectors include:

  • animal breeding
  • bio-control
  • biotechnology
  • collections
  • cosmetic and personal care
  • food and feed
  • pharmaceutical
  • plant breeding
  • research institutions

Compliance responsibility

The regulations in the UK apply to any company, organisation or individual conducting research and development on genetic resources and / or aTK (the user) where:

  • the genetic material and / or aTK was accessed on or after 12 October 2014

and

  • was from a country that is party to the Nagoya Protocol and has access and benefit sharing (ABS) legislation

The user of the genetic resource and / or aTK is responsible for undertaking due diligence. This is to ensure that the material is accessed in accordance with applicable legislation of the providing country. The user is also responsible for the submission of a due diligence declaration as required.

How to comply

In the EU, a company, individual or organisation wishing to use a genetic resource and / or aTK from a country that is a party to the Nagoya Protocol must exercise due diligence to show that relevant country requirements have been met. Depending on the national measures that apply, the user may need to demonstrate prior informed consent (PIC) to access the genetic resource and assent to mutually agreed terms (MAT) for undertaking research and development. These terms will also provide for benefit sharing, whether this is in monetary or non-monetary form, as well as addressing aTK associated with a genetic resource.

The Access and Benefit Sharing Clearing House (ABSCH) is a platform for exchanging information on access and benefit sharing measures that countries have established, as well as supporting the tracking of genetic resources between provider and user. It assists the implementation of the Nagoya Protocol and parties are required to place national legislation on it to provide legal clarity. Users of genetic resources should use this information source as part of their due diligence process.

Making a due diligence declaration

There are two checkpoints in the research and development phase where users of genetic resources submit a due diligence declaration:

1) when in receipt of research funding in the form of a grant, for work involving utilisation of genetic resources and / or aTK

and

2) at the stage of final development of a product developed via the utilisation of genetic resources and / or aTK with such resources

Safety & Standards requests all recipients of research funding involving the utilisation of genetic resources and aTK to submit a due diligence declaration.

This request is directed at any recipient established in the UK that receives a financial contribution by means of a grant to carry out research, whether from commercial or non-commercial sources. The declaration should be made after the first installment of funding has been received and all the genetic resources and aTK that are utilised in the funded project have been obtained, and no later than at the time of the final report or project end.

Users of genetic resources and / or aTK must also submit a due diligence declaration at the stage of final development of a product, developed from the utilisation of genetic resources and / or aTK.

The conditions under which this declaration would be required are outlined in the Implementing Regulation (EU) 2015/1866.

Where research and development is undertaken in the UK, due diligence declarations can be submitted to Safety & Standards through using the online application, DECLARE.

For further guidance please read The DECLARE NAGOYA IT system user guide questions and answers (MS Word Document, 1.15MB) document.

Where can I find out more?

Guidance on compliance measures for users (European Commission)

Access and Benefit Sharing Clearing House (ABSCH)

Nagoya Protocol on Access and Benefit-sharing (Convention on Biological Diversity)

This includes the text of the Nagoya Protocol and helpful factsheets.

If you have a specific enquiry about compliance with the regulations, please use the contact details on our enforcement services page.

Regulations in force in the UK

Nagoya Protocol (Compliance) Regulations 2015

Regulation (EU) No. 511/2014: compliance measure for users

Regulation (EU) 2015/1866: register of collections, monitoring user compliance and best practices

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Published 2 June 2015
Last updated 19 October 2017 + show all updates
  1. Updated to reflect that due diligence can now be submitted through the new EU IT system DECLARE.
  2. First published.