1) Is screening the Phytotitre library compliant with the Nagoya Protocol?

Yes. Please see below for further explanation.

2) What is the Nagoya Protocol?

The Nagoya Protocol is an international agreement under the Convention on Biological Diversity (CBD). It establishes a legal framework to ensure that when researchers or companies exploit genetic resources (such as plants, microbes, or animals) or related traditional knowledge in particular ways, the benefits are shared fairly with the countries providing them. Its aim is to promote the sustainable use of biodiversity while respecting the rights of those countries that choose to apply the Protocol.

3) What impact does the Nagoya Protocol have on UK-based researchers?

(i) Are the planned research or development activities within the scope of the Nagoya Protocol regulations?

(ii) Does the material originate from a country which has both ratified the Nagoya Protocol, and chosen to exercise their rights to claim mutual benefits from their native genetic resources?

If the answer to either questions is no, the planned activities can continue with no further action necessary. If the answer to both questions is yes, the individual, company or institution should seek to liaise with a representative of the provider country to obtain Prior Informed Consent (PIC), and agree Mutually Agreed Terms (MAT) governing benefit sharing, which could involve research collaborations or profit sharing.

4) What types of activity fall under the scope of the Nagoya Protocol regulations?

The use of any plant material for non-research use, such as through cultivation or consumption as commodities, is not covered by the Nagoya Protocol. Instead, the regulations apply to activities involving the “utilisation of genetic resources” - that is, research and development on the genetic or biochemical composition of plants, animals, microbes, or other biological materials, particularly when relating to development of a new commercial product. Such activities may include laboratory analysis, sequencing, bioactive compound isolation, or any work generating new knowledge or products from a genetic resource.

5) Does screening a plant extract library fall under the scope of the Nagoya Protocol?

No, screening a plant extract library, such as the Phytotitre collection, does not fall within the scope of the Nagoya Protocol.

The UK’s Department for Environment Food & Rural Affairs (DEFRA) offers guidance on which research activities fall within the scope of the Nagoya Protocol in the following publication:

Guidance on the UK Access and Benefit Sharing Regulations
Section 6.8 covers the screening of natural product collections:

6.8 Large scale screening
"Large scale screening means an activity which involves the evaluation of usually large numbers of genetic resource samples against a specific criterion. The process is frequently automated and involves questions of a binary nature (i.e. does this sample match the criterion, or not?). The objectives of the activity are (a) to screen out the vast majority of samples which are not of interest to and will not be used for the research project (‘negative’); and (b) identify the few samples which may have the potential for further research within the terms of the project (‘positive’). Such a type of screening activity, which is based on simple binary questions and resolved by identical tests performed on multiple samples in a standardised way to screen out the majority of them, would not fall in scope of the ABS Regulations on the basis that it does not amount to utilisation of a genetic resource. It does not constitute ‘research and development’ as understood in the context of the regulations, since no added scientific insight in relation to the screened-out samples is created.”

6) At what point would research activities fall within scope of Nagoya Protocol?

If a hit extract is found, and a researcher seeks to isolate specific biochemical compounds from the plant of interest with the aim of establishing their biological activities and/or progressing them towards a commercial use, then the work may fall under scope of the Nagoya Protocol.

7) If I want to further develop a hit extract from screening the Phytotitre library into a drug lead or commercial product, will I have to liase with and obtain a PIC and MAT from a provider country?

Not necessarily. This will only apply if you choose to source the plant material for further study from a country that has both ratified the Nagoya Protocol, and chosen to regulate access to their genetic resources via the Protocol.

As of October 2025, 142 of 195 nations have ratified the Nagoya Protocol, and of these, 63 have chosen not to implement a legal framework covering the Protocol. Of the remaining 79 nations, many have a legal framework in place to monitor compliance or their own researchers with the Protcol, but choose not to regulate access to their own natural resources. For example, both the UK and Sweden have legislation in place to ensure that their research activities comply with the Nagoya Protocol, but allow unhindered access to their own biodiversity without requirement for PIC or MAT from other nations.

The Phytotitre collection does not contain extracts of any plants that are rare, endangered, or unique to any one country. All source plants are either widely cultivated across many different nations, or harvested sustainably from a wide geographic region spanning many nations. It will be possible, if the researcher so chooses, to source plant materials for further study from a nation that chooses to apply Nagoya Protocol access measures, or not. Notably, the Protocol applies to the country in which the plant was grown and harvested, not the country where it may have evolved or been first cultivated. An up to date list of nations which choose to exercise access requirements can be found at the Access and Benefit Sharing Clearing House website: https://absch.cbd.int/en/

Maintaining a record of this investigation at the point of transitioning from screening activities to drug development will form a necessary part of the “due dilligence” expected of UK researchers.

8) Who is responsible for monitoring compliance with Nagoya Protocol in the UK?

The UK’s Office for Product Safety and Standards (OPSS), within the Department for Business and Trade, is the competent authority responsible for monitoring compliance with Nagoya Protocol in the UK.