Nagoya Protocol

The Nagoya Protocol is an international agreement that sets rules for how people can use genetic material from plants, animals, and other non‑human organisms, as well as any traditional knowledge linked to these resources.

At UWE Bristol, all staff and students involved in research must follow these rules. This means you must check that any genetic resources or related traditional knowledge you use were obtained legally and with the proper permission from the country they came from. You are also responsible for making sure any agreed benefits are shared fairly with that country.

Genetic resources: any plant, animal, microbial or material of other origin which contains functional units of heredity which is of actual or potential value, or derivatives.

Traditional knowledge: knowledge, know-how and practice of indigenous and local communities relevant for the utilisation of the genetic resources accessed under the protocol.

Utilisation: conducting research and development on the genetic and/or biochemical composition of genetic resources. Utilisation is also understood to mean development and marketing of products based on genetic resources.

Compliance with Nagoya Protocol applies when the following conditions are met:

• The genetic resource and/or associated traditional knowledge was accessed on or after 12 October 2014; and
• The genetic resource and/or associated traditional knowledge was accessed from a country which is party to the Nagoya Protocol and has applicable ABS (Access and Benefit Sharing) legislation.

• Non-human genetic resources taken directly from the country of origin, i.e. from a country party to the Nagoya Protocol.
• Non-human genetic resources obtained from outside the country of origin (ex-situ), for example a botanical garden in the UK, non-wild sources such as zoos, seed gene banks, pollen storage.

A genetic resource is material that is (or compromises a sample or extract of) any of the following:

• domesticated or cultivated animals 
• cultivated plants or crops
• laboratory strains
• human microbiota (if it constitutes non-human material)
• plant genetic resource for food and agriculture (PGFRA)
• wild plants, fungi, fish, animals, insects, microorganisms, virus
• soil, water, air or other environmental samples that may contain genetic resources
• forest reproductive material or marine samples that may contain genetic resources
• genetic resources obtained from an ex-situ collection
• genetic resources obtained from a registered collection
• derivates of genetic resources (e.g. sequencing data, proteins, enzymes)

Please note that some countries offer free access to genetic resources if used in non-commercial/academic research. For more information, please check the ABS restrictions map.

What is not in scope

• Human genetic resources.
• Genetic resources already governed by specialised international agreements such as the International Treaty on Plant Genetic Resources for Food and Agriculture, or the WHO
• Pandemic Influenza Preparedness Framework.
• Genetic resources as traded 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 of the genetic resource.
• Genetic resources that are used for maintenance of a collection for conservation purposes (i.e., not for research purposes).
• Genetic resources obtained from areas beyond national jurisdiction (for example, from the high seas), or from areas covered by the Antarctic Treaty System.
• 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.

The due diligence steps required vary depending on how the genetic resource was accessed.

For direct access (i.e. using genetic resources obtained directly from the country of origin by the researcher):

1. Please get in touch with the Research Integrity Governance and Ethics (RIGE) Office (researchgovernance@uwe.ac.uk) to set up processes that will need to take place at UWE Bristol (e.g. contracts).
2. Use the ABS Clearing House to identify the relevant national laws, procedures and contact points in the countries from which you wish to source material.
3. Gain prior informed consent (PIC) and agree terms and conditions of access; this should also include agreements about dissemination of results, publications and sharing of data, and potential exploitation. 
4. After PIC is obtained, the University will negotiate Mutually Agreed Terms (MAT) with the Competent National Authority.
5. Comply with these terms throughout research. If this is not possible, the PIC and MAT must be renegotiated.

For indirect access (i.e. the genetic resource is accessed from a third party e.g. collaborator, private/registered collection, botanical garden etc):

1. Contact the RIGE Office (researchgovernace@uwe.ac.uk) to help you navigate the process. 
2. Confirm whether PIS and MAT were established by the intermediary when resources were originally accessed (or seek records confirming that PIC and MAT were not required). 
3. Check whether you need other permits (e.g. export control, access to protected areas etc.).
4. Confirm that the transfer and intended utilisation are covered by PIC and MAT. 
5. If not apply for a new or modified PIC and MAT from the provider country.

For transfer/providing access to material that is subject to Nagoya Protocol: 

1. Ensure transfer/provision of access is consistent with the original access and benefits-sharing agreements.
2. The transferred information must be kept by the new holder and included in any subsequent transfers. 

If you determine that your work is not within the scope of the Nagoya Protocol:

1. Please keep a record of your actions that determined the genetic resource was not within the scope as a ‘due diligence’ record for 20 years.
2. No further action is required to ensure compliance with the Protocol or regulation.

If you are using genetic resource accessed under Nagoya, you are required to keep the following information:

• The date and place the genetic resource and associated traditional knowledge were acquired.
• A description of the items acquired, using unique identifiers where they are available.
• The source from which the items were obtained. 
• Whether the items are subject to rights and obligations regarding access and benefit sharing. 
• Any decisions made regarding the access, as well as the mutually agreed terms of access. 

All records related to access (direct or indirect) or transfer of genetic resources and associated traditional knowledge need to be kept for 20 years following the end of the period of use.  

If your work needs to follow the Nagoya Protocol, please get in touch with RIGE Office (researchgovernance@uwe.ac.uk). 

We need to register the project for audit purposes. We can also assist you by directing you to the right Committee (Biological Safety or/and AWESC) and help you liaise with the Contracts team as appropriate.

• Regulations: Nagoya Protocol on access and benefit sharing (ABS)
• ABSCH: Access and Benefit-Sharing Clearing-House
• Nagoya Protocol Text and Annex Document (Convention on Biological Diversity) (PDF)
• Access and benefit sharing: Simply explained (English) (YouTube)
• Access and benefit sharing: Implementing the Nagoya Protocol in the UK (YouTube)
• Nagoya Protocol (University of Cambridge)