Nagoya Protocol

The Nagoya Protocol applies to both those who gain access to genetic resources either directly from the country of origin and those who gain access indirectly through a third party.

There are four elements to consider when establishing if the genetic resource you are using falls under the Nagoya Protocol: Materials, Timeframe, Location, Activity.

All four elements need to be within scope for the regulations to apply. If only 3 of the 4 elements apply to your research then it will not come under the Protocol.

Material

The Protocol applies to ALL genetic resources intended for research and development. There are a few exceptions which are listed below:

• Resources covered by existing ‘specialised international instruments’ such as the WHO’s Pandemic Influenza Preparedness (PIP) Framework or International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA)
• Human genetic resources
• Commodities traded for direct consumption or use within consumables

Timeframe

The Protocol applies to resources (or traditional knowledge) which was accessed:

• After 12 October 2014
• From secondary/intermediary sources after 12 October 2014 requiring that they meet all other criteria

Resources accessed before this date are not in scope even if they were not utilised until after that date.

Location

The Protocol applies only to countries that have ratified the protocol. You can find more information at the Access and Benefit=Sharing Clearing House which includes geographical areas that are governed by specific ratifying countries.

If you are unsure, contact the relevant country’s ABS National Focus Point for confirmation.

If the origin country has not ratified the Protocol, then they are not in scope, however they may still have their own legislation you have to comply with

Genetic resources coming from areas beyond national jurisdiction (such as areas under the Antarctic Treaty System or the high seas) are not in scope.

If you are accessing genetic resources from multiple different countries, then you must consider each providing country as a separate entity.

If the resources are coming from a local indigenous community, it is best practice to establish mutually agreed terms for access with the community to avoid any issues.

The UK does not regulate its own genetic resources so if you are exclusively working with resources originating from within the UK then no further action is needed.

Activities

The definition of utilisation is ‘to conduct research and development on the genetic or biomechanical composition of genetic resources or their derivatives included through their application of biotechnology.’ This includes commercial and non-commercial research and may be basic or applied research.

The Protocol applies to all genetic resources intended for research and development. There are a few exceptions:

• The access material is used as testing/reference material for other test materials subjected to research and development
• Genetic resource that already has a known activity/purpose and the research being conducted is in relation to that activity (e.g. supply of aloe vera for the use in cosmetics)
• Material stored for describing phemotypic reference (botanical gardens) with no intention to be involved in research and development
• Genetic resource that already has a known activity and no new research will be carried out with it (e.g. supply of yeast for the brewing).

If your research is within scope then you will need to arrange certain agreements before starting your research using the genetic material. During your research you will be required to keep detailed records (specified in section below), and to submit Due Diligence declarations to DEFRA at specific points (see below).

Before using any genetic resource from abroad, please use the Nagoya Protocol Checklist for Researchers to determine if your research is within scope or not.

Even if your research is not within scope, please keep a copy of the completed checklist within your study records.

If you find your study is within scope, then you will need to conduct the following activity. Please note this will differ depending if you are accessing the resource direct from the country of origin or indirectly through a third party.

Direct access

1. Use the ABS Clearing House to determine the national laws and processes in the origin country which you need to follow, and also to identify useful contacts
2. Make all reasonable efforts to obtain a Prior Informed Consent (PIC) if the ABS guidance states this is required.
   Explainer: A PIC is the permit obtained from the provider country that holds sovereign rights over the genetic resource that is being accessed. This permit outlines the use of the resource
3. Negotiate a Mutually Agreed Terms (MAT) if the ABS guidance states this is required. Please contact the Research Contracts Team to assist with this (RKEContracts@hull.ac.uk)
   Explainer: A MAT is the contract between the provider and user which details terms of use, timeframes, transfer, benefit sharing terms and permissions around third parties.
4. Confirm if any other permits are required (e.g. export controls or other access measures)
5. Conduct and maintain records of due diligence, before during and after the transfer of resources.

Indirect access

1. Contact the third party and establish what agreements were in place when the origin country first provided the resource.
   • Where possible, obtain copies of the PIC and MAT used in the initial transfer of the resource. Ensure that your transfer complies with the relevant terms and conditions.
   • If you cannot comply with the terms and conditions from the original agreements, you will need to apply for new or modified versions.
   • Where PIC and MAT agreements were not used initially, you will need to obtain these for your transfer. You will also need to clarify why they were not used.
2. Confirm if any other permits are required (e.g. export controls or other access measures)
3. Conduct and maintain records of due diligence, before during and after the transfer of resources.

Researchers must submit a due diligence declaration at two specific checkpoints using the template available on the Gov.uk website

1. At the point of receipt of funding in the form of a grant, for the utilisation of genetic resources
2. At the final development stage of a product developed via the use of genetic resources where:
   1. Market approval or authorisation is sought
   2. Notification is required prior to placing on UK market
   3. Placing on the UK market for the first time where no approval, authorisation or notification is required
   4. The result of the use of genetic resource is being sold or transferred in any way outside of the UK in order for points a. b. or c. to happen
   5. The use of the product in the UK has ended and its outcome is sold or transferred in any way outside of the UK

Researchers should complete the Due Diligence Declaration forms and send to Research Compliance (researchcompliance@hull.ac.uk) to will review and will then submit to DEFRA on behalf of the researcher and institution.

The lead researcher accessing the genetic resources must keep a record of all activities for 20 years following the end of the utilisation of the resource. This should also be shared and kept with the institution.

The following documents should be maintained and recorded:

• Copy of completed checklist
• Screenshots from ABS Clearing House regarding country of origin
• Any PIC/MAT agreements (if applicable)
• Any Internationally Recognised Certificate of Compliance (IRCC) issued (if applicable)
• Any communications with the National Focal Point of country of transfer (if applicable)
• Communications with any third party (if applicable)
• Due Diligence Declaration forms
• Any other relevant information

The lead researcher must share copies of all records with the institution by sending them to researchcompliance@hull.ac.uk

When a study is found to not be in scope, the lead researcher should still retain a copy of the completed checklist (along with any other documentation relevant to the Protocol) within the study records.