This page provides a guide to the Nagoya Protocol, deciding if your research is in scope of the Nagoya Protocol and information on the next steps if that is the case.
You might find it helpful to look at our FAQs.
You can download our checklist to guide you in deciding whether your planned research is in scope of the Nagoya Protocol. Note that completing this checklist is required for ethical approval. It will also act as a record of the due diligence required under the Nagoya Protocol legislation.
We are conducting a survey of genetic resources - access it here.
- What is the Nagoya Protocol?
- Where can I obtain advice?
Please contact your BDO before accessing materials within the scope of the Nagoya Protocol, including derivatives such as enzymes. Please note that the policies and regulations vary for each country. Your BDO will work with you to check the policies and assist with the procedure that needs to be followed in each case.
- How do I determine if my research falls within the scope of the Nagoya Protocol?
The following provides a quick guide to whether your research might be in scope:
1. Intended Use
- Are the genetic resources being utilised for Research & Development? Regulations apply to discovery or examination of specific genetic and/or biochemical traits, biotechnological applications (using biological systems, living organisms or derivatives to make or modify products or processes) as well as R&D that leads to the development of a new product.R&D is taken to include basic and applied research, non-profit and commercial research. Utilisation of a GR or its derivatives for the purposes of R&D even if no commercial output can be envisaged at the time is in scope if all other criteria are met.
- If a subcontractor/service provider performs activities for someone else that are considered utilisation, they are not obliged to follow ABS regulations as long as they adhere to a service agreement that outlines their restricted rights in terms of the material. More information can be found in our FAQs
- Is the material brought deliberately to the UK? Only those materials imported intentionally (e.g. as commodity, being transferred by the user) are in scope.
- Are the genetic resources (GR) human? Human GR are not in scope. Non-human GR or their derivatives are in scope if they meet all other criteria.
- Are the genetic resources (GR) covered by an existing ‘specialised international ABS instrument’? If the GR and its utilisation are covered by specialised agreements which have already established ABS conditions, such as the International Treaty on Plant Genetic Resources for Food and Agriculture or the WHO’s Pandemic Influenza Preparedness Framework, the work is not in scope if the provider country is party to that agreement.
- Are the genetic resources and/or aTK accessed from the provider country (= country of origin) or a 3rd party on or after 12th October 2014?
- Does the provider country exercise their sovereign rights over the genetic resource at the time of access (do they regulate access)? Some countries, like the UK, are parties but don’t regulate access to their genetic resources so no permission needs to be sought.
4. Geographic scope
- Is the provider country a Party to the Nagoya Protocol? If the provider country has ratified the Nagoya Protocol then resources from that country are in scope if they meet all other criteria.
- My research is likely to be in scope - what are the next steps?
- How do I proceed if my research is in scope?
The Due Diligence Declaration form can be downloaded from the UK ABS Regulations website. Anyone who has submitted a previous Due Diligence Declaration via the EU DECLARE system will not need to resubmit these as they have been uploaded to the Access and Benefit Sharing Clearing House (https://absch.cbd.int/countries/GB).
- What are the penalties for not complying with the Nagoya Protocol?
- Compliance Self-Assessment Tool
The OPSS has created a free self-assessment tool that aims to help users understand their requirements and record information related to compliance.
- Best Practice and Registered Collections
Under the Nagoya Protocol, best practices and registered collections may become recognised. The conditions for best practice recognition and registered collection status can be found under the Nagoya Protocol (Compliance) (Amendment) (EU Exit) Regulations 2018
Process for submitting due diligence declarations, applying for best practice and registering a collection in the UK
From 01 January 2021, UK stakeholders involved in accessing genetic resources from Parties to the Nagoya Protocol are required to follow new UK processes for the following.
- Submitting a due diligence declaration
- Applying for best practice recognition
- Registering a collection in the UK
- Sources of Further Information
- Legal Definitions
(taken from Article 3 of the EU Regulation 511/2014)