Nagoya Protocol

The Nagoya Protocol is an international agreement that intends to prevent unfair exploitation of foreign countries when accessing and using their genetic resources. Genetic resources have been of substantial value for human life, e.g. in the development and production of food sources, medicine and cosmetics. As agreed upon at the UN Rio Summit 1992, countries have sovereign rights over the genetic resources within their borders, and any use of genetic material from plants, animals and other living organisms is subject to access and benefit-sharing principles. The Nagoya Protocol provides the legal framework to implement these principles, and thereby contributes to the conservation and sustainable use of biodiversity.

To be precise, The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilisation to the Convention on Biological Diversity is a 2010 supplementary agreement to the 1992 Convention on Biological Diversity. Its aim is the fair and equitable sharing of benefits arising out of the utilisation of genetic resources (GR), as well as associated traditional knowledge (aTK). From 12^th October 2014, anyone who wishes to access genetic resources and/or the traditional knowledge associated with resources in participating countries will be required to comply with these regulations.

A genetic resource is any plant, animal, microbial or material of other origin which contains functional units of heredity and is of actual or potential value. The genetic resource derivatives, such as enzymes, natural products and similar, are also covered by the Nagoya Protocol. Human genetic resources are not covered by the Nagoya Protocol.

Traditional knowledge associated with genetic resources means 'traditional knowledge held by an indigenous or local community that is relevant for the utilisation of genetic resources and that is as such described in the mutually agreed terms applying to the utilisation of genetic resources. Such traditional knowledge includes knowledge, innovations and practices, of indigenous and local communities embodying traditional lifestyles, relevant for the conservation and sustainable use of biological diversity.

The regulations apply when research and development is conducted on genetic resources and/or associated traditional knowledge. The legislation is implemented and enforced in the UK by the Office for Produce Safety and Standards (OPSS), part of the Department for Business, Energy & Industrial Strategy.

Your Business Development Officer (BDO) will be able to provide guidance on the implementation of the Nagoya Protocol and adherence to the UK ABS Regulations.  You can contact your BDO using nagoyaprotocol@abdn.ac.uk.

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.

The following provides a quick guide to whether your research might be in scope:

There are four considerations to determine if a specific use of genetic resources (GR) is covered by the UK ABS Regulations (https://www.gov.uk/guidance/abs).

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

2. Material scope

• 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.

3. Temporal scope

• Are the genetic resources and/or aTK accessed from the provider country (= country of origin) or a 3^rd party on or after 12^th 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.
• If the provider country is not a Party to the Nagoya Protocol then resources from that country are not in scope, however, they might have their own access requirements.

1. Review the ‘scope’ criteria systematically to determine if there is any reason that the GR you wish to use does not fall within the scope of the UK ABS Regulations. See also our FAQs.
2. Find out more information about the provider country by accessing their profile on the ABS Clearing House. If you are unsure about whether the provider country has established access measures for the material based on the information available on the ABS Clearing House, you should contact that country’s named ABS National Focal Point to confirm and keep a record of their response. You can also contact your Business Development Officer to ask if they have experience with ABS regulations of that country.
3. Even if you decide that the GR you wish to use does not fall within the scope of the UK ABS Regulations, keep a record of your actions as a ‘due diligence’ record.

1. Note: Prior to taking any action, email nagoyaprotocol@abdn.ac.uk for guidance and advice specific to your particular circumstances.  The following information is provided as a general guide to the process.

   Based on UK ABS Regulations:

   Depending on the national measures that apply in the relevant country,

   1. Obtain ‘Prior Informed Consent’ (PIC) - a permit which outlines the permitted use - from the provider country before research activities begin.

   2. Negotiate ‘Mutually Agreed Terms’ (MAT) – a contract between the provider country and the user – which outlines terms of use, timeframes, permissions regarding transfer of material to third parties and benefit sharing arrangements before research activities begin. Benefit sharing may be monetary or, in terms of research, could include joint publication, student exchanges or other partnership activities. The benefits are intended to support the conservation of biological diversity and the sustainable use of its components globally.

   3. Throughout the period of use, conduct and maintain records of due diligence. Due diligence involves gathering and using information in a systematic way to demonstrate that the necessary information related to a GR is available all throughout the value chain. This will include your initial steps to determine if a GR is in scope of the UK ABS Regulations and any discussions you have had with a provider country’s National Focal Point. 

   4. Do not transfer GR to any third party unless your PIC & MAT give you permission to do so. To demonstrate compliance with the UK ABS Regulations, users are required to seek, keep, and transfer to subsequent users’ key information either by (1) referring to an international certificate of compliance (IRCC) associated with their access to the GR or (2) seeking and acquiring the necessary information. The key information users must seek, keep, and transfer to subsequent users if they are permitted to do so is:

• date and place of access to GR
• a description of the GR
• the source from which the GR were directly obtained
• any existing rights and obligations relating to access and benefit sharing
• access permits, if applicable
• mutually agreed terms, if applicable

5. File due diligence declarations if appropriate. There are two checkpoints in the research and development phase where users of genetic resources must submit a due diligence declaration:

Checkpoint 1: when in receipt of research funding in the form of a grant, for work involving utilisation of genetic resources and/or aTK. 

All recipients of research funding involving the utilisation of genetic resources and aTK must submit a due diligence declaration to the Department for Environment, Food and Rural Affairs (Defra).

This requirement is directed at any recipient established in the UK that receives a financial contribution by means of a grant to carry out research, whether from commercial or non-commercial sources.  The declaration should be made after the first instalment of funding has been received and all the genetic resources and aTK that are utilised in the funded project have been obtained, and no later than at the time of the final report or project end.

and

Checkpoint 2: at the stage of final development of a product developed via the utilisation of genetic resources and/or aTK with such resources where:

1. market approval or authorisation is sought for a product developed via the utilisation of genetic resources and aTK
2. a notification required prior to placing for the first time on the UK market is made for a product developed via the utilisation of genetic resources and aTK
3. placing on the UK market for the first time a product developed via the utilisation of genetic resources and aTK for which no market approval, authorisation or notification is required
4. the result of the utilisation is sold or transferred in any other way to a natural or legal person within the UK in order for that person to carry out one of the activities referred to in points 1, 2 and 3

or

5.  the utilisation in the UK has ended and its outcome is sold or transferred in any other way to a natural   or legal person outside the UK.

Due diligence declarations should be submitted to the Competent National Authority of the country where the utilisation takes place.  Where research and development is undertaken in the UK, due diligence declarations must be submitted to Defra.

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).

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 Office for Produce Safety and Standards (OPSS) will carry out checks on user compliance and these checks will be conducted on 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.

If a user has decided that genetic resources or associated traditional knowledge are out of scope, the user will be asked to justify their decision.

Non-compliance may result in civil sanctions (or criminal sanctions in serious cases or in the event of continual non-compliance).  The OPSS may impose compliance notices and monetary penalties.

The OPSS has created a free self-assessment tool that aims to help users understand their requirements and record information related to compliance.

The tool can be downloaded from the UK ABS Regulations webpage (https://www.gov.uk/guidance/abs).

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

Further guidance can be downloaded from the UK ABS Regulations webpage (https://www.gov.uk/guidance/abs).

You may wish to review the ABS webinar, July 2021. This video presentation  from the Nagoya Regulator in the UK - Office for Product Safety and Standards (OPSS) provides a 35 minute introduction to the Nagoya Protocol.

A Nagoya toolkit has been developed by the University’s marine biotechnology staff.

The ABS Capacity Development Initiative was established in 2006 to support the development and implementation of national regulations on “Access and Benefit Sharing” (ABS).  Their website provides a number of helpful guidance documents, including the following explanatory videos:-

• ABS – Simply Explained (5 minutes) – A short video explaining more about Access and Benefit Sharing (ABS) and the Nagoya Protocol.
• People, Plants and Profit (25 minutes) – This video explains the background to the Nagoya Protocol and about Access and Benefit Sharing, and provides three examples where genetic resources were used prior to the Nagoya Protocol.   (It also contains the above ‘ABS – Simply Explained’ video.)
  The Convention on Biological Diversity website provides fact sheets about the Nagoya Protocol in addition to an ABS Information Kit. 
• Defra Guidance – ‘Nagoya Protocol – UK Processes for submitting Due Diligence Declarations, applying for Best Practice and registering a Collection in the UK’

Useful Weblinks:

• Nagoya Protocol (Compliance) Regulations 2015 (S.I. 2015/821) as amended
• Nagoya Protocol (Compliance) (Amendment) (EU Exit) Regulations 2018 (S.I. 2018/1393)
• Environment and Wildlife (Legislative Functions) (EU Exit) Regulations 2019 (S.I. 2019/473)
• The Convention on Biological Diversity
• Access and Benefit-Sharing Clearing-House (platform for exchanging information on ABS and a key tool for facilitating the implementation of the Nagoya Protocol)
• UK Regulations: The Nagoya Protocol on access and benefit sharing (ABS)
• Policy Option for Access and Benefit-sharing and Digital Sequence Information (pdf)

 (taken from Article 3 of the EU Regulation 511/2014)

Genetic material means 'any material of plant, animal, microbial or other origin containing functional units of heredity' i.e. containing genes.

Genetic resources means 'genetic material of actual or potential value'.

Derivatives is defined as 'a naturally occurring biochemical compound resulting from the genetic expression or metabolism of biological or genetic resources, even if it does not contain functional units of heredity'.

Access means ‘the acquisition of genetic resources or of traditional knowledge associated with genetic resources in a Party to the Nagoya Protocol.

User means 'a natural or legal person that utilises genetic resources or traditional knowledge associated with genetic resources'.

Utilisation of genetic resources means 'to conduct research and development on the genetic and/or biochemical composition of genetic resources, including through the application of biotechnology as defined in Article 2 of the Convention'.

Mutually agreed terms means ‘the contractual arrangements concluded between a provider of genetic resources, or of traditional knowledge associated with genetic resources, and a user, that set out specific conditions for the fair and equitable sharing of benefits arising from the utilisation of genetic resources or of traditional knowledge associated with genetic resources, and that may also include further conditions and terms for such utilisation as well as subsequent applications and commercialisation’.

Traditional knowledge associated with genetic resources means 'traditional knowledge held by an indigenous or local community that is relevant for the utilisation of genetic resources and that is as such described in the mutually agreed terms applying to the utilisation of genetic resources'.

Illegally accessed genetic resources means ‘genetic resources and traditional knowledge associated with genetic resources which were not accessed in accordance with the national access and benefit-sharing legislation or regulatory requirements of the provider country that is a Party to the Nagoya Protocol requiring prior informed consent’.

Collection means ‘a set of collected samples of genetic resources and related information that is accumulated and stored, whether held by public or private entities’.

Association of Users means ‘an organisation, established in accordance with the requirements of the Member State in which it is located, that represents the interests of users and that is involved in developing and overseeing the best practices referred to in Article 8 of this Regulation’.

Internationally recognised certificate of compliance (IRCC) means ‘a permit or its equivalent issued at the time of access as evidence that the genetic resource it covers has been accessed in accordance with the decision to grant prior informed consent, and that mutually agreed terms have been established for the user and the utilisation specified therein by a competent authority in accordance with Article 6(3)(e) and Article 13(2) of the Nagoya Protocol, that is made available to the Access and Benefit-Sharing Clearing House established under Article 14(1) of that Protocol.