The Nagoya Protocol

The Nagoya Protocol came into being in 2010, putting more detail to the ‘Access and Benefit Sharing’ (ABS) principles from the Convention on Biological Diversity (CBD) in a legally binding way.  It was adopted by European legislation through ‘Regulation (EU) No 511/2014’ and came into force on 12 October 2014. 

This was then implemented into UK law in 2015. The regulations in force in the UK are:

• The Nagoya Protocol (Compliance) Regulations 2015 (UK Statutory Instrument, No. 821)

• Regulation (EU) No 511/2014 on compliance measures for users from the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilisation in the Union
• Implementing Regulation (EU) 2015/1866 laying down the detailed rules for the implementation of Regulation (EU) 511/2014 as regards the register of collections, monitoring user compliance and best practices

The legislation is implemented and regulated in the UK by the Office for Product Safety and Standards (Safety & Standards). Therefore from 12 October 2014 anyone who wishes to access genetic resources and/or the traditional knowledge associated with resources must comply with the EU Regulation.   

On the Access and Benefit-Sharing Clearing-House website you will find details of which countries are party to the Nagoya Protocol; meaning those that have implemented it into their own legislation and therefore giving users a route by which to seek access to genetic resources.   In addition, it is important to check the legislation of the country that holds the resources/knowledge (provider country) as they may have additional rules regarding access.

There are several likely touch points where researchers will come into contact with questions or requirements related to the Nagoya Protocol on access and benefits-sharing (ABS). These include:

• applying for a research grant (e.g. you may be asked to describe ABS considerations or have agreements)
• being awarded a research grant (e.g. you may be required to demonstrate ABS approvals compliance)
• seeking ethical approval
• going to obtain or purchase genetic resources
• seeking to lodge material in collections (museums, laboratories, libraries, gardens or other locations)
• seeking to provide or give access to genetic resources to: other researchers, other units in the University, or external organisations
• seeking to patent certain discoveries (where it is suspected that genetic resources from another country have been used). For these patents to progress applicants will need to prove that agreements relating to the collection and use of the genetic resources are in place with the host country. Alternatively, they will need to show that they have carried out 'due diligence' to check that the material falls outside of the scope of the legislation).
• seeking to sell or in other ways commercialise resources or products based on genetic resources.
  This is a particular focus under the protocol to ensure that providers of material and local knowledge (including indigenous and local communities) receive a fair and equitable share of benefits.

To undertake due diligence researchers should follow these steps.

1) Determine whether or not the material is subject to the Nagoya protocol:

• Is it a genetic resource
• Is the genetic resource non-human? (Human material is exempt)
• Check whether the genetic resource is not already covered by existing legal agreements i.e. the International Treaty on Plant Genetic Resources for Food and Agriculture.
• Is the genetic resource found within an area of national jurisdiction? For instance, high seas are not in scope.
• If the answer to any of the above is no, proceed to step 6. Otherwise proceed to step 2.

2) Determine whether the genetic resources will be ‘utilised’ by you or a third party:

• Is the genetic resource being used for research and development?
• If not, proceed to step 6.

3) If so, determine the timing of access and utilisation:

• Was the genetic resource accessed directly (or indirectly) and utilised after 12th October 2014?
• If not, proceed to step 6.

4) If so, determine whether the country of origin has ratified the Nagoya Protocol?

• Using the ABS Clearing House, determine whether the country of origin has ratified the Nagoya Protocol?
• If unsure, contact that country’s named ABS National Focal Point (NFP) designated under the Protocol to confirm whether access measures are in place. If the NFP fails to respond after reasonable attempts have been made to contact them, you must decide for yourselves whether or not to access or utilise the genetic resource in question. Keep a record of your efforts to obtain guidance from the NFP.
• If you determine that access and use of the materials is not covered by applicable measures, proceed to step 6.
• If you have confirmed there are access measures or are unsure, it is necessary to undertake further due diligence – please proceed to step 5. 

5) Undertaking due diligence:

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):

• Using the ABS Clearing House, determine whether the access measures include requirements to obtain ‘prior informed consent’ (PIC) and ‘mutually agreed terms’ (MAT) for the genetic resource.
• If unsure, contact that country’s named ABS National Focal Point designated under the Protocol to confirm.
• If required, apply for PIC. This involves submitting the required information (which will vary) to the identified entry points and stakeholders of the provider country (e.g. may include the Competent National Authorities, local communities and different levels of government) and may be time consuming.
• If materials or knowledge associated with genetic materials are obtained from indigenous or local communities, it is best practice to negotiate mutually agreed terms for access even if this is not required in the national legislation.
• Check whether you need other permits (e.g. export control, access to protected areas etc.)
• After PIC is obtained, it is necessary for the University to negotiate MAT with the Competent National Authority.
• The Competent National Authority in the provider country issues a national permit or its equivalent to the user and publishes a record on the ABS Clearing House website.
• The ABS Clearing House generates an Internationally Recognised Certificate of Compliance (IRCC)
• 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):

• Inquire about the best way to obtain the genetic resource for your project from the intermediary (this may vary depending on if the intermediary is a registered collection, collaborator, ex situ facility etc.)
• Confirm whether PIC and MAT were established by the intermediary when the resources were originally accessed (or seek records confirming that PIC and MAT were not required)
• Obtain PIC and MAT from the intermediary. This will likely be in the form of an IRCC, but may alternatively be in the form of equivalent information.
• Confirm that the transfer and your intended utilization are covered by PIC and MAT conditions.   
• If not, apply for new or modified PIC and MAT from the provider country. 

For transfer: (i.e. giving the genetic resource to a third party):

• Transferring genetic resources must be in accordance with requirements set out in PIC and MAT.
• The transfer should include:
• the internationally recognised certificate of compliance (IRCC) associated with their access to the genetic resource (or equivalent information)
• access permits and MAT, if applicable, and
• The transferred information must be kept by the new holder and included in any subsequent transfers.

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

• Please keep a record of your actions that determined the genetic resource was not within the scope as a ‘due diligence’ record.
• No further action is required to ensure compliance with the Protocol or regulation.
• Researchers should be aware, however, that some nations may have their own ABS legislation unrelated to the Nagoya Protocol  and would need to be followed.  

The EU Regulation on ABS requires researchers to submit a declaration of due diligence if using genetic resources covered by the Nagoya Protocol. This will allow countries to monitor and exchange information on ABS compliance under the Nagoya Protocol.

There are two checkpoints or situations that trigger a declaration of due diligence:

• receiving research grants – i.e. after the receipt of the first instalment of funding but before the final project report/end of project.
• reaching the final stages of product development (i.e. commercialisation).

A due diligence declaration will require:

• Basic information on the project (title and brief description or the grant code)
• Evidence that access to the genetic resources used was carried out in accordance with the protocol (usually a copy of the IRCC or an equivalent national permit)

Where research and development is undertaken in the UK, due diligence declarations can be submitted to Safety & Standards through using the online application, DECLARE.

For further guidance please read The DECLARE NAGOYA IT system user guide questions and answers (MS Word Document, 1.15MB) document.

Users of genetic resources accessed under the Nagoya Protocol are required to seek, keep, and transfer to subsequent users, information about the following:

• the date and place the genetic resources 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 decision made regarding the access, as well as the mutually agreed terms of access. 

Users are:

• required to maintain such information for a period of 20 years following the end of the period of use
• mandated to declare at identified points that they have complied with their due diligence obligations
• subject to audit/inspection by the regulatory authorities

The regulator in the UK, the Office for Product Safety & Standards (OPS&S), will carry out checks on user compliance.

The checks will be conducted through a risk-based approach. Additional checks will be conducted when a competent authority is in possession of relevant information concerning a user's non-compliance.

Where a user has judged genetic resources (or associated traditional knowledge) to be out of scope and therefore not requiring compliance, the authorities will ask for justification of why it is thought to be out of scope.

The Office for Product Safety & Standards will have the power to impose compliance notices and variable monetary penalties. Non-compliance will normally be dealt with through civil sanctions, although OPS&S will be able to pursue criminal sanctions in serious cases.