IP Cases & Articles

The Nagoya Protocol - Actions for genetic researchers

The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization was adopted by contracting states on 29 October 2010, and ratified by the European Union (EU) in a Regulation on 16 May 2014.

The Nagoya Protocol is a supplementary agreement to the Convention on Biological Diversity (CBD). The CBD itself is a multilateral treaty centred on achieving three main goals, namely:

1. The conservation of biological diversity.

2. Sustainable use of its components.

3. Fair and equitable sharing of benefits arising from genetic resources.

A notable non-signatory to either the CBD or Nagoya Protocol is the US.

It was hoped that the CBD would stimulate the use of genetic resources however over time it was apparent that this hope would not be fulfilled. This is one of the reasons for which the Nagoya Protocol was devised. Further aims of the Nagoya Protocol are the establishment of more predictable conditions for access to genetic resources and to help ensure benefit-sharing.

Key points of the Nagoya Protocol

The Nagoya Protocol surrounds the utilization of genetic resources which it defines as any non-human genetic resources. The term ‘utilization’ refers to research and development on the genetic and/or biochemical composition of genetic resources including through the use of biotechnology. The breadth of this term therefore encompasses both commercial and academic research.

The Nagoya Protocol gives provider countries the rights to control access to genetic resources found within their jurisdiction, thereby reaffirming a provider country’s sovereignty over these resources. A provider country can be either: an originating country where the genetic resource exists in situ; or one where the genetic resource exists ex situ and where it has been obtained from an originating country under the CBD. It is yet to be confirmed, but would appear that an originating country may be able to impose terms on subsequent provider countries.

A key part of the Nagoya Protocol is that the burden will be placed on the user (ie, researcher) to show that any genetic resource on which they are conducting research was legally obtained in accordance with the Nagoya Protocol. To do this a user must obtain the prior informed consent of a providing country before access to a genetic resource is permitted (Article 6 of the Nagoya Protocol). There must also be fair and equitable sharing of benefits arising from utilisation of genetic resources with the party providing access thereto on mutually agreed terms (Article 5 of the Nagoya Protocol).

Article 4 of the EU regulation implementing the Nagoya Protocol requires users to exercise due diligence to ascertain that genetic resources have been accessed in accordance with the access and benefits sharing regulatory requirements. Additionally for 20 years following the end of utilisation the user must keep the internationally recognised certificate of compliance or information/documents concerning:

• the date and place of access;

• the description of genetic resource utilised;

• the direct source of genetic resource and subsequent users; and

• access and benefit sharing (ABS) agreements, access permits, mutually agreed terms including benefit-sharing, and any rights or obligations related to ABS.

Although the EU regulation introduces much of the Nagoya Protocol as national law for member states, national governments have been allowed to decide how to implement:

• the issue of traditional knowledge associated with genetic resources that is held by indigenous and local communities (Nagoya Protocol Articles 7 and 16);

• the appointment of the competent authority to administer the Nagoya regime in the member state;

• details of how declarations of due diligence are to be made; and

• enforcement and sanctions for failure to comply with due diligence obligations - civil sanctions and criminal offences.

Focal points and competent authorities

It is also envisaged that under the Nagoya Protocol national focal points (NFPs) and competent national authorities (CNAs) will be established to serve as contact points for information, grant access or to cooperate on issues of compliance.

The Nagoya Protocol in the UK

The UK’s Department for Environment Food and Rural Affairs (DEFRA) will be responsible for implementing the EU regulation relating to the Nagoya Protocol. As yet there is no set guidance on how the due diligence requirements will be implemented. The EU regulation requires that the penalties for non-compliance with the due diligence requirements of the Protocol must be “effective, proportionate and dissuasive.” Details of such penalties have not yet been published, but DEFRA have suggested a fine of up to £250,000 as well as possible criminal sanctions.

Actions for researchers

1. Ensure all existing materials are documented as having been accessed pre-Nagoya (as the regulation will not be retroactive).

2. Put in place systems to ensure that new materials are documented in compliance with the Nagoya Protocol.

3. Ensure employees know about the Nagoya Protocol and associated regulation and that, in future legal possession of a genetic resource does not necessarily imply the right to do any work on it.

4. Be cautious of the origin of material that you might wish to use for research.

5. Consider whether you want to be involved in setting best practices concerning work practices to conform to the legislation.

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