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Nagoya Protocol

An international legal framework that enables the fair and equitable sharing of non-human genetic resources including the traditional knowledge associated with the resources, and the benefits that arise from their use.

Every country holds sovereign rights over the biodiverse resources such as animals, plants and genetic materials that exist within their borders. To help protect these rights, the Convention of Biological Diversity (CBD) adopted the Nagoya Protocol on Access and Benefit Sharing. The Nagoya Protocol came into force on 12 October 2014 and provides a legal framework for the implementation of one of the CBD's three main objectives; the fair and equitable sharing of the benefits arising out of the utilization of genetic resources. Currently 141 countries have signed up to the Protocol including the UK.  

Access and Benefit Sharing video:

In the UK, the Nagoya Protocol is implemented and enforced by the UK Government's Office for Product Safety and Standards (OPSS). Research institutions can be subject to inspections by the OPSS and failure to comply with the Nagoya Protocol can lead to fines and reputational damage. It is therefore important that researchers (and especially those based in Life Sciences, Psychology and BSMS) are aware of their responsibilities regarding this legislation.

What is covered by the Nagoya Protocol?

The Nagoya Protocol applies to non-human genetic resources and any associated traditional knowledge (aTK) which are sourced from countries that are signatories to the Protocol and have access and benefit sharing (ABS) legislation. However, it is important to note that non-signatory countries are still likely to have their own local access legislation (i.e. a requirement for permits). Further details regarding this can be found on the Access and Benefit-Sharing Clearing-House website (ABSCH).

Definitions for the purposes of the legislation

• Genetic Resources:  any material of plant, animal, microbial or other origin (excluding human) containing functional units of heredity (e.g. genes and DNA) which is of actual or potential value; or their derivatives, e.g. proteins, lipids, enzymes or RNA.
• Associated Traditional Knowledge (aTK): knowledge, know-how and practice of indigenous and local communities relevant for the utilisation of the genetic resource.
• Utilisation: to conduct research and development on the genetic and/or biochemical composition of genetic resources, including through the application of biotechnology.

Examples of activities considered 'in scope'

• Plasmid constructs where inserts originate from international sources, accessing repositories of organisms/constructs, protein samples e.g. serum, soil samples from cores (geological applications).
• Non-human cell lines used to study cell signalling or responses to potential drugs or infection.
• Microorganisms used to establish potency or mechanism of action for compounds of interest.
• Research on a genetic resource leading to the isolation of a biochemical compound used as a new ingredient in a pharmaceutical product.
• Research into the genetic and/or biochemical composition of the organism, i.e. research and/or development in relation to gene function and inheritable traits.
• Genetic modification, i.e. creation of a genetically modified plant containing a gene from another species.
• Creation or improvement of yeasts, resulting from action through an R&D process, to be used in a manufacturing process.

What is excluded from the Nagoya Protocol?

The Nagoya Protocol does not apply to the following:

• Human genetic resources, digital sequence data or synthetic gene segments synthesised without access to the physical genetic resource. However, please note that the legislation might apply to genetic resources derived from human microbiota.
• Genetic resources (and any aTK) 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.
• Genetic resources (and any aTK) obtained from areas beyond national jurisdiction, e.g. from the high seas, or from areas covered by the Antarctic Treaty System.
• Genetic resources that are 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 on the genetic resource.
• Genetic resources used for the maintenance of a collection for conservation purposes.
• Genetic resources used as a testing or reference tool in research, i.e. the genetic resource is not the object of the research, but serves to confirm or verify the desired features of another experiment or study.
• Descriptive research, i.e. describing a species/taxonomy.
• Ecological research, i.e. research into how an organism interacts with its environment.

How to comply with the Nagoya Protocol

Researchers should follow the below step-by-step guide to ensure compliance with the Nagoya Protocol. Please note that compliance with the Protocol (if applicable) must be achieved before samples are sent to the University.

1. Use our online Nagoya Protocol checklist (opens in a new tab) to determine whether the Nagoya Protocol is applicable. Once submitted, the results of this checklist will be visible to the Senior International Governance Officer and saved as evidence that the Nagoya Protocol has been considered. If it is determined that the Nagoya Protocol is applicable, the researcher will be offered support in working through the compliance steps outlined below. Alternatively, if it is determined that the Nagoya Protocol is not applicable then please skip to step 7 below.
2. Undertake the following due diligence process to ascertain that ABS requirements will be met (along with any other specific measures in place in the provider country):
   1. Direct access i.e. genetic resource (including any aTK) obtained from its country of origin: 
      • Check the Access and Benefit-Sharing Clearing-House website (ABSCH) to see which national laws apply, what access measures are required and how to make contact.
      • Obtain Prior Informed Consent (PIC), often administered by the relevant Competent National Authority, if the country of origin requires it. 
      • If required, establish Mutually Agreed Terms (MAT) in negotiation with the Competent National Authority, or a community, in the country of origin.
      • Check whether any other authorisations or permits are required such as an export licence or access to protected areas.
      • Once the above steps are completed, the provider country will issue a national permit and publish a record on the ABSCH website. This will then trigger the ABSCH to generate an Internationally Recognised Certificate of Compliance (IRCC) which acts as evidence that the genetic resource (and any aTK) has been accessed in line with ABS legislation. 
   2. Indirect access i.e. genetic resource (including any aTK) accessed via a third party such as a collaborator, collection or botanical garden:
      • Check whether PIC and MAT were established at the original point of access and ensure that these permit a transfer of the genetic resource (and any aTK) to Sussex for the purposes envisaged.
      • Obtain evidence of the PIC and MAT (most likely in the form of the IRCC). Alternatively, if PIC and MAT were not required, seek records confirming this. 
      • Put in place an appropriate Material Transfer Agreement (MTA) with the third party.
      • If a transfer is not possible either because the original agreement does not permit it or the IRCC is not available, the researcher will need to apply for a new or modified PIC and MAT directly with the provider country (see “direct access” process outlined above).
3. Once the genetic resource (and any aTK) has been received by Sussex, the researcher must inform the Senior International Governance Officer by emailing trustedresearch@sussex.ac.uk so that they can provide support in submitting the required due diligence declaration form to Defra. This form is required at two checkpoints: 1) after receipt of the first instalment of grant money issued to support the utilisation of the genetic resource (and any aTK), and 2) upon reaching the final stage of product development (commercialisation). The form can be downloaded here: Defra due diligence declaration form (ODT)
4. Ensure that the agreed ABS terms for accessing the genetic resource (and any aTK) are complied with throughout the duration of the research project.
5. Keep appropriate records to show that the relevant requirements have been met. These records may be audited by the regulator and should be stored for a minimum 20 years after the end of utilisation (including copies of the PIC, MAT and/or MTA, IRCC and any relevant permits). Please liaise with the Senior International Governance Officer via trustedresearch@sussex.ac.uk to maintain these records.  
6. If the genetic resource (and any aTK) held by Sussex is subsequently transferred to a third party, researchers must ensure that the purpose for which it is being provided is in line with the original ABS requirements as set out in the PIC and MAT. The transfer should include the associated IRCC (or equivalent), any access permits and the MAT (if applicable). 
7. If it is determined that the Nagoya Protocol is not applicable to the genetic resource (and any aTK) being accessed then no further action is required except for keeping a record of the steps taken to determine this. For examples of what can be used as evidence that the project is out of scope of the Nagoya Protocol, please refer to section 7.3 of Defra’s Guidance on the UK Access and Benefit Sharing Regulations (pdf). However, researchers should be aware that some nations may have their own ABS legislation unrelated to the Nagoya Protocol that would need to be complied with. 

Considering the Nagoya Protocol throughout the research life cycle 

The following research-related activities and stages of the research life cycle are examples of key checkpoints which should prompt consideration of the Nagoya Protocol: 

• when applying for a research grant (you may be asked to describe ABS considerations or have agreements in place).
• when being awarded a research grant (you may be required to demonstrate ABS approvals compliance at the outset or within a specified period).
• when applying to your head of department/school for permission to undertake fieldwork.
• when seeking to obtain or purchase genetic resources.
• when seeking to submit material into a collection held in places such as museums, laboratories, libraries, gardens or herbaria (you will almost certainly be asked to show ABS compliance and records).
• when seeking to provide or give access to genetic resources to: other researchers, other units in the University, or external organisations.
• when seeking to patent certain discoveries (where it is suspected that genetic resources from another country have been used).
• when seeking to sell or in other ways commercialise resources or products based on genetic resources.