The Nagoya Protocol

Components

Countries have rights over the genetic resources that exist within their country such as, animals, plants and organisms as well as their associated traditional knowledge. The Nagoya Protocol on Access to Benefit Sharing (ABS) is an international agreement establishing a legal framework for the implementation of one of the three objectives of the Convention of Biological Diversity (CBD). Its aim is to govern access to genetic material including the associated traditional knowledge, and ensure that benefits arising from these resources are shared fairly.

Definitions

Genetic resources in the context of the Nagoya Protocol, includes any non-human genetic resource which can include, any material of plant, animal, microbial or other origin containing functional units of heredity which is of actual or potential value, or derivatives.

The protocol also recognises the “interrelationship between genetic resources, and traditional knowledge, their inseparable nature for indigenous and local communities, the importance of the traditional knowledge for the conservation of biological diversity and the sustainable use of its components, and for the sustainable livelihoods of these communities”.

UK Implementation to date

12 October 2014: The Nagoya protocol was adopted as part of European legislation (EU Reg. 511/2014 Art. 5). These regulations focus on compliance measures for users for users of the Nagoya Protocol on access to genetic resources and the fair and equitable sharing of benefits arising from their utilisation.

The Nagoya Protocol (Compliance) Regulations 2015:

  • 9July 2015:Parts 1 and 2 came into force
  • 12 October 2015: Parts 3 and 6 and the Schedule came into force

9 November 2015: Rules regarding the registration of the collection of genetic resources, monitoring user compliance and best practice comes into force (EU Reg. 2015/1866)

The Nagoya is a supplementary agreement to the Convention of Biological Diversity (CBD).

The Nagoya Protocol and the research life cycle

There are a number of time points where you will need to consider, where relevant, the Nagoya Protocol.

These can include:

  • When applying for research funding:You may be asked to describe ABS considerations or provide evidence of agreements in place.
  • Upon being awarded funding:You may be required to evidence ABS compliance.
  • When applying for ethical approval: You will need to demonstrate that you have considered the Nagoya protocol, and can evidence how you will ensure compliance with the legislation.

Due Diligence

The due diligence actions required varies depending on how the genetic resource was obtained.

In order to evidence due diligence, you should be able to demonstrate that:

  • There was Prior Informed Consent (PIC) of a provider country before access to a genetic resource was permitted.
  • Mutually Agreed Terms (MATs) have been established.
  • A fair and equitable sharingof the benefits arising from the utilisation of a genetic resource (and the associated traditional knowledge) has been established with the provider country.

Upon receiving funding for research involving the utilisation of genetic resources and traditional knowledge, EU member states will be asked to declare that due diligence was exercised in accordance with the Nagoya Protocol.

There are two EU provisions which can help in exercising due diligence:

This is an internet based register established by the European Commission (EC) comprising sets of collected samples of genetic resources that is accumulated and stored.

In accessing samples from this resource, users will be deemed to have exercised due diligence in accordance with EU regulations.

Associations of Users may submit an application to the EC to have a combination of procedures, tools or mechanisms, developed by them, recognised as a best practice in accordance with the protocol. However, the applications needs to be supported with evidence and information.

Documentation to be retained

All information relating to access and benefits sharing must be kept by the user for 20 years after the period of utilisation.

My research falls within the remit of the Nagoya protocol. What do I do now?

If you have identified that your research falls within the remit of the Nagoya protocol, please contact the R&I Contracts team and copy in the Research Ethics and Governance team. These two teams will be able to advise and support you about what steps need to be taken.