The CBD recognises that Countries have rights over genetic resources within their jurisdiction and borders. The Nagoya Protocol applies to all genetic resources over which States exercise sovereign rights resources, where such countries have ratified the Nagoya Protocol and established applicable access measures.

Researchers who utilise genetic resources, including the traditional knowledge associated with those resources, should ensure that these are accessed in accordance with the access and benefit sharing laws and procedures as laid out by the Provider Country.

For the purposes of the Regulation the following definitions mean:

‘Genetic resources’ any material of plant, animal, microbial or other origin (excluding human) containing functional units of heredity which is of actual or potential value; or derivatives

‘Utilisation’ means to conduct research and development on the genetic and/or biochemical composition of genetic resources, including through the application of biotechnology.

‘Traditional knowledge’ means traditional knowledge held by an indigenous or local community that is relevant for the utilisation of genetic resources and that is as such described in the mutually agreed terms applying to the utilisation of genetic resources.

‘Access’ means the acquisition of genetic resources or of traditional knowledge associated with genetic resources in a Party to the Nagoya Protocol.

The Protocol does not apply to:

• Genetic resources obtained from areas beyond national jurisdiction (for example, from the high seas), or from areas covered by the Antarctic Treaty System
• Human genetic material
• Genetic resources already governed by specialised international agreements that are consistent with the Protocol, e.g. the International Treaty on Plant Genetic Resources for Food and Agriculture; the WHO Pandemic Influenza Preparedness Framework.
• Trade and Exchange of genetic resources as commodities (such as agricultural, fisheries or forestry products, whether for direct consumption or as ingredients, e.g. in food and drink products), as long as there is no research and development on the genetic resource.
• Genetic resources that are used for the maintenance of a collection for conservation purposes, where there is no intention to undertake research utilising the genetic resource
• Genetic resource is being used as a testing/reference tool in the research, i.e. it is used to confirm or verify another product but is not the object of the research.

Researchers who are intending to access genetic resources, are required to undertake due diligence to ensure that the resources and traditional knowledge associated with those resources are accessed in accordance with applicable access and benefit sharing laws.

Researchers should undertake the following checks to ensure compliance.

1. Determine whether the genetic resource is within the scope of the Nagoya Protocol and the EU regulation.

a. The material is a genetic resource (plants, animals, microbial or any material containing functional units of heredity, or their derivatives)?

b. The material is non-human (human material is excluded)?

c. The exclusions listed above do not apply?

d. The genetic resource will be utilised for Research & Development by you or a third party?

e. The genetic resources were accessed directly (obtained from its country of origin by you or a third party) after 12 October 2015?

f. The Provider Country is a party to the Nagoya Protocol? A list of current countries who have ratified the Nagoya Protocol, can be found on the ABS clearing house. 

g. The Provider Country has established measures relating to the ABS for the genetic resources? All parties to the Nagoya Protocol are required to make their legislative, administrative and policy measures on ABS available on the ABS clearing house. If you are unclear on whether the Provider Country has established ABS measures then you should contact that country’s named ABS National Focal Point.

Answering “Yes” to all the questions above means utilisation of the genetic resources is within the scope of the Nagoya Protocol, and you are required to undertake a due diligence review.

If you determine that your utilisation of the genetic resources is not within the scope of the Nagoya Protocol you should keep a record of your actions and evidence of your decision.

Researchers should also be aware that some countries have their own ABS legislation outside the scope of the Nagoya protocol which should also be followed.

2. Due Diligence Review

The due diligence steps that researchers are required to undertake is determined by how you access the genetic resources:

2.1 Direct Access:

Using genetic resources that researchers have obtained directly from the country of origin.

• Determine whether access measures on the ABS clearing house, include the requirements to obtain ‘prior informed consent (PIC)’ and ‘mutually agreed terms (MAT)
• If PIC is required, this should be sought from the identified entry points and stakeholders from the relevant country, this information is also available on the ABS clearing house
• Once the PIC has been obtained, please get in touch with your R&IS contact at your earliest convenience, who will be able to draft and negotiate appropriate MAT
• Throughout your research and whilst utilising the genetic resources you should comply with the PIC and MAT at all times.

2.2 Indirect Access:

Using genetic resources accessed from third party (intermediary), such as collaborators, registered collections etc.

• Confirm with the intermediary whether Prior Informed Consent (PIC) and Mutually Agreed Terms (MAT) were obtained when the genetic resources were originally accessed. If PIC and MAT were not required seek evidence from the intermediary confirming this
• Obtain PIC from the intermediary for your use of the genetic materials. Once the PIC has been obtained, please get in touch with your R&IS contact, who will be able to draft and negotiate appropriate MAT
• If your intended utilisation of the genetic resources is not covered by the original PIC and MAT, a new or modified PIC and MAT will be required from the Provider Country.

3. Due Diligence Declarations

There are two checkpoints defined in the EU Regulations, which trigger the requirement for a due diligence declaration to be submitted

Checkpoint 1: On receipt of a research grant to support the utilisation of the genetic resource. The declaration is required after the first instalment of funding has been received and the genetic resources have been obtained, but before the final project report.

Checkpoint 2: At the final stages of product development (i.e. commercialisation).

Declarations should be made using the Due Diligence Declaration template forms available from the BEIS Office for Product Safety and Standards (OPSS) website. Completed forms are to be submitted to Defra by emailing abs@defra.gov.uk.

4. Record Keeping

To demonstrate compliance with the Nagoya Protocol, users of genetic resources are required to seek, keep and transfer to subsequent users key information, either by (1) referring to an international certificate of compliance (IRCC) associated with their access to the genetic resource or (2) seeking and acquiring the necessary information. The following key information should be retained:

• Date and Place of access that the Genetic Resource was acquired
• A description of the genetic resource, include any unique identifiers
• The source from which the genetic resource was obtained
• Any existing rights and obligations relating to access and benefit sharing
• Access permits, if applicable
• Mutually Agreed Terms (MAT).

Users are required to maintain this information for a period of 20 years following the end of the period of utilisation. Compliance with the Nagoya Protocol and Regulation (EU) No. 511/2014 is subject to audit by regulatory authorities.