The Nagoya Protocol

What is the Nagoya Protocol?

The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization (ABS) to the Convention on Biological Diversity is a supplementary agreement to the Convention on Biological Diversity (CBD). It provides a transparent legal framework for the effective implementation of one of the three objectives of the CBD: the fair and equitable sharing of benefits arising out of the utilization of genetic resources.

The Nagoya Protocol on ABS was adopted on 29 October 2010 in Nagoya, Japan and entered into force on 12 October 2014 (coming into force in UK law on 9th July 2015). Its objective is the fair and equitable sharing of benefits arising from the utilization of genetic resources, thereby contributing to the conservation and sustainable use of biodiversity.

What is covered?

The regulations apply when research and development is conducted on genetic resources and / or associated traditional knowledge (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.

Extent of obligation

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

  • was accessed on or after 12 October 2015
  • was accessed from a country that is party to the Nagoya Protocol and has access and benefit sharing (ABS) legislation
  • is not already governed by a specialised international instrument (such as the PIP Framework or the ITPGRFA)

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

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.

OPSS has created a free self-assessment tool that aims to help users understand their requirements and record information related to compliance. You do not need to return the completed form.

Making a due diligence declaration

There are two checkpoints in the research and development phase where users of genetic resources must submit a due diligence declaration to Defra (abs@defra.gov.uk):

  1. when in receipt of research funding in the form of a grant, for work involving utilisation of genetic resources and / or aTK
  2. at the stage of final development of a product developed via the utilisation of genetic resources and / or aTK with such resources

Further information on this process, including downloadable forms can be found here