Accessing Genetic Resources from Abroad (including the Nagoya Protocol)

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 territory, and any use of genetic material from plants, animals and other living organisms is subject to Access and Benefit-Sharing (ABS) principles:

• Access: users are required to obtain necessary permits as specified in the national ABS laws. Part of this is Prior Informed Consent by the country.
• Benefit-sharing: Mutually Agreed Terms for the use of GR are negotiated and agreed upon.

How countries regulate this (which material needs a permit, the process of obtaining permits etc) is up to them. Whenever accessing genetic resources or derivatives abroad, researchers need to do their due diligence regarding ABS laws. Relevant permits to access and an agreement about use of the material and potential benefit-sharing needs to be in place before the research can commence.

The Nagoya Protocol provides an additional legal framework to help enforce principles when accessing genetic resources. If the material and use is in the scope of the Nagoya Protocol, the researcher has additional obligations, such as submitting due diligence declarations. Projects in scope of the Nagoya Protocol can be audited by the Office for Product Safety and Standards, and researchers/institutes can be penalised if they are not compliant.

Summary of researcher’s obligations:

Exercise due diligence and determine if the material of interest

a) underlies ABS laws

b) is in scope of the Nagoya protocol

Reminder: Even though not legally enforced by the UK, researchers must still follow ABS regulations when accessing genetic resources which are not in scope of the 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.

If you are planning to use genetic material or derivatives (chemical extracts, proteins, lipids, sequences etc), you need to check your obligations:

1. What are your rough plans?

Consider which organisms you want to obtain material or derivatives from, from which country this material originates, and what type of research you intend to do. Based on this, check if there is an Access and Benefit-Sharing agreement that would apply to you, such as the “International Treaty on Plant Genetic Resources for Food and Agriculture”. Make sure you would be following the conditions of that agreement. If your research plans are not covered by one, you need to check if there are ABS laws applying to you.

2. Check which country you want to access material from. Does it have ABS laws?

• Look up the country’s profile on the ABS Clearing House (ABSCH) website. Make a note if it is party to the Nagoya Protocol.
• The legislative, administrative or policy measures section of the country might provide information on the regulations. If the measures are not described there, the interim reports might contain helpful information.
• Note: Not all countries provide information on their ABS laws on the ABSCH. To find out about regulations, contact the ABS National Focal Point and/or the Competent National Authority. Check if the National Focal Point on the Convention on Biological Diversity (CBD) page is the same, in case the contact was not updated on the ABSCH.

If you receive no answer:

• Ask collaboration partners in the provider countries for help as it might be easier for them to contact the authorities in their own country and language.
• Use the internet to find resources.
• Contact the OPSS. They have information about ABS and may be able to assist, or can tell you what you need to do to comply.

3. Check whether the laws apply to your research by considering…

• Material: Some laws only include certain types of organisms and material
• Use: ABS obligations may or may not apply depending on the type of research. Some countries have e.g. exemptions for non-commercial research.
• Double-check if there are any specific ABS laws in other general laws of the country, or ask the National Focal Point for advice. If you can determine based on the available information that your research is definitely exempt, you don’t need to continue to do anything – but keep documentation to prove your due diligence.

4. Follow the ABS process

• Start preparing early! It can take several weeks or months to negotiate the agreements. Check out the ABS Strategy Checklist of the Nagoyaprotocol Hub for additional considerations
• Plan out your research needs to make sure your agreement will cover everything. The following (non-exhaustive) list of questions might help:
  • What type of organism does the genetic resources or derivative stem from (species, communities..?)
  • Will the material be collected in the field or from a third party?
  • Will associated traditional knowledge be used as part of the research?
  • What will be done with the material?
  • Are there collaboration partners involved?
  • What part of the research will take place in the provider country, and what part in the UK (or other involved countries)?
  • What type of material will be exported to which country for this?
  • Will sequences be obtained and published in databases?
  • Will the results be published in academic journals?
  • Will part of the research remain confidential?
  • What happens to the material after your project ends?
  • Do you plan to make material available for other researchers?
  • Will intellectual property rights be obtained over the research?
• Inform your Research Development Executive that you need to obtain permits, as they and the Contracts Team can help you with the negotiations along the way.
• Consider what type of benefits you can share. A few examples would be:
  • Collaboration/joint publication with local researchers and institutes
  • Sharing results, data, publications etc
  • Providing funding, equipment, infrastructure of relevance
  • Training for local scientists and students
  • Joint ownership of relevant intellectual property rights
  • Monetary benefits from commercialisation
  • Research directed towards priority needs
• Only start your research once permits are in place, and only perform the research your agreement with the provider country outlines!

5. Nagoya compliance

• If the country is party to the Nagoya Protocol, you might have additional obligations – check if your project is in scope of the Nagoya Protocol

Reminder: Even if your project is not in scope of the Nagoya Protocol, you will still need to follow the country’s access and benefit-sharing regulations. The Nagoya Protocol is a framework allowing the UK government to check your compliance with regulations on projects that fall into 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, you still need to follow the country’s Access and Benefit-Sharing laws.

You can download our checklist to guide you in deciding whether your planned research is in scope of the Nagoya Protocol. It will also act as a record of the due diligence required under the Nagoya Protocol legislation.

If you are uncertain if your research is in scope of the Nagoya Protocol, contact the OPSS and explain your research plans to them: OPSS.enquiries@beis.gov.uk

1. Note: Prior to taking any action, contact your Research Development Executive 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.