Nagoya Protocol compliance shapes EU sourcing of genetic resources for R&D

More than a decade after the Nagoya Protocol entered into force, access and benefit-sharing (ABS) rules remain one of the less visible compliance considerations for businesses that source or use genetic resources in research and development.

The international and European framework applies broadly: from plant-derived active pharmaceutical ingredients (APIs) and pathogen samples used in diagnostic assay development, to fermentation cultures in food production and botanical extracts in cosmetics. Yet few companies map ABS exposure systematically, and fewer still have dedicated compliance processes in place.

In the EU, Regulation (EU) 511/2014 imposes due diligence obligations on users of genetic resources, and Member States are continuing to sharpen national enforcement. Several have recently strengthened their national enforcement frameworks – including Poland and Spain in recent months – and further activity across European jurisdictions is expected.

For pharma, biotech, diagnostics, food, cosmetics and animal health businesses, ABS rules can affect sourcing strategies, collaboration agreements, grant processes and product development timelines wherever biological materials or community-derived knowledge enter the value chain.

Global framework 

The Nagoya Protocol is a supplementary agreement to the 1992 United Nations Convention on Biological Diversity (CBD). The CBD established three objectives: the conservation of biodiversity, its sustainable use, and the fair and equitable sharing of benefits arising from the utilisation of genetic resources. The Nagoya Protocol operationalises this third objective by creating an international ABS regime. It had been ratified by 138 countries as of 2025.

The protocol reaffirms the sovereignty of states over natural resources within their jurisdiction, sets out basic conditions for how access to genetic resources should be governed, and lays down principles for how benefits resulting from their utilisation should be shared, including with indigenous and local communities. 

Recent international developments around genetic resources, intellectual property (IP) and benefits sharing have also included a World Intellectual Property Organisation (WIPO) treaty, which, when in force, will establish a new international disclosure rule for patent applicants whose inventions are based on genetic resources or associated traditional knowledge. The WIPO requirement would be separate to those in the Nagoya Protocol.

Broad practical reach

The purpose of the Nagoya Protocol is to ensure the fair and equitable sharing of benefits arising from the utilisation of genetic resources, including by ensuring appropriate access to those resources, with a view to contributing to the conservation of biological diversity and the sustainable use of its components. The protocol also concerns traditional knowledge associated with genetic resources and benefits arising from the utilisation of such knowledge.

The compliance exposure under the protocol turns on how its core terms are defined.

• "Genetic resources" means genetic material of actual or potential value.
• ​"Genetic material" is any material of plant, animal, microbial or other origin containing functional units of heredity. Human genetic material is excluded.
• ​"Utilisation of genetic resources" is broadly defined as research and development on the genetic or biochemical composition of genetic resources, including through biotechnology. This definition is wide enough to capture activities ranging from bioprospecting for novel drug compounds to the characterisation of microbial strains for use in feed enzymes or cosmetic formulations.
• "Biotechnology" means any technological application that uses biological systems, living organisms, or derivatives thereof, to make or modify products or processes for specific use.

​The protocol casts a wide net: any business that wishes to access genetic resources or associated traditional knowledge in a signatory state and to use those resources in research and development (R&D), is likely to be subject to that country's ABS rules. This can cover a range of activities: developing a pharmaceutical product from plant-derived compounds, validating a diagnostic assay using pathogen samples, formulating a cosmetic ingredient from botanical extracts, or screening fermentation cultures for food applications. The use of genetic resources as traded commodities – for example, purchasing fruit for consumption – does not trigger ABS obligations but any subsequent research on those resources typically would.

Provider and user obligations

The Nagoya Protocol distinguishes between countries that provide genetic resources ("provider countries") and countries where genetic resources are used ("user countries").

​Provider countries are required to regulate access to genetic resources and associated traditional knowledge on the basis of prior informed consent (PIC) and mutually agreed terms (MAT). User countries must adopt "appropriate, effective and proportionate" measures to ensure that genetic resources and associated traditional knowledge used within their jurisdiction have been accessed with PIC and under MAT, and must address non-compliance.

PIC requirements

Prior informed consent requires users to obtain permission before accessing genetic resources. A provider country must be given certain information – including the identity of the user, the purpose and expected benefits of that use, and any planned transfer to third parties – before access can proceed.

Provider countries are expected to create clear, non-arbitrary procedures for requesting and obtaining lawful access, including by designating competent authorities and issuing permits that can serve as internationally recognised certificates of compliance. In practice, implementation varies considerably across countries. Some are restrictive in granting access; others are more permissive. Country-specific evaluation is usually necessary.

For businesses, PIC requirements can directly affect R&D timelines: a pharmaceutical company sourcing plant-derived compounds for drug discovery, a cosmetics firm obtaining shea butter or argan oil for product development involving biochemical analysis, or an in vitro diagnostic (IVD) manufacturer seeking pathogen samples from a biobank for assay validation may each need to navigate provider-country consent procedures before work can begin.

MAT provisions

Mutually agreed terms are contractual clauses that typically address the manner in which genetic resources may be accessed, the permitted uses, and benefit-sharing obligations. They can also cover intellectual property rights, third-party use, dispute resolution and benefit-sharing arrangements (both monetary and non-monetary). The protocol introduces checkpoints to monitor utilisation of genetic resources at stages such as research funding, development and commercialisation, and emphasises mechanisms for access to justice and enforcement of ABS-related agreements.

MAT can have practical implications across sectors. For example, a collaboration agreement between a European biotech firm and an institution in a provider country for access to microbial samples may need to include benefit-sharing clauses, restrictions on downstream transfer to partners, and reporting obligations at defined development milestones.

Sector impact

While obligations under the Nagoya Protocol fall formally on states, the practical effect is that companies, universities, research centres and other users are expected to undertake due diligence on the origin and legal status of genetic resources and associated traditional knowledge they intend to use. Where genetic resources have not been accessed in compliance with applicable ABS rules, users may face reputational damage, liability risks and enforcement action, depending on the countries concerned.

Certain countries have made non-compliance punishable by administrative or criminal penalties. Enforcement measures can include fines, withdrawal of public funding, personal liability and the seizure of assets.

​The breadth of affected activities is often underestimated. Examples of compliance triggers across sectors include:

• Pharmaceuticals and biotech. Bioprospecting programmes using natural compounds, microbial samples or plant-derived APIs; accessing pathogen samples for vaccine or biological product development.
• Diagnostics and IVD. Pathogen samples acquired for assay development or validation; biobank materials used as reference standards; genomic data used in PCR (polymerase chain reaction)-molecular test design.
• ​Animal health and feed. Veterinary vaccine development using certain pathogens; probiotics and enzyme development from microbial genetic resources; sourcing of breeding materials.
• ​Food and beverage. Fermentation cultures for food or novel food development; functional ingredients sourced from specific regional plant varieties; research into bioactive compounds or flavourings derived from genetic resources.
• ​Cosmetics and personal care. Botanical extracts such as shea butter, argan oil or algae-derived ingredients where R&D on their biochemical composition is involved; traditional knowledge associated with natural ingredients used in product development.

ABS in the EU

The EU implemented the Nagoya Protocol through Regulation (EU) 511/2014 on compliance measures for users from the Nagoya Protocol, which focuses on user compliance. The regulation imposes obligations on both EU Member States and users of genetic resources.

Regulation 511/2014 requires users to exercise due diligence to ascertain that genetic resources and associated traditional knowledge which they utilise have been accessed in accordance with applicable ABS rules, and that benefits are fairly and equitably shared under MAT. Genetic resources and associated traditional knowledge may only be transferred and utilised in accordance with MAT.

​More specifically, users must seek, keep and transfer to subsequent users an internationally recognised certificate of compliance, together with information on the content of the MAT relevant for subsequent users. Where no internationally recognised certificate exists, other documents may be used. Users must retain information relevant to ABS for 20 years after the end of the period of utilisation.

Member States must designate competent authorities to enforce ABS rules, monitor user compliance – including by requiring certain information and conducting controls – and enact penalties for non-compliance. Although Regulation 511/2014 applies across the EU, implementation and enforcement still vary across Member States. A jurisdiction-specific evaluation remains prudent.

For digital health, medtech, pharma, food, cosmetics and biotech businesses active in or supplying into the EU, this framework can affect sourcing strategies, collaboration agreements, grant processes and product development timelines where biological materials or community-derived knowledge are involved. 

More broadly, the enactment of the BBNJ (Biodiversity Beyond National Jurisdiction) Act, which brings the UK closer to ratifying the High Seas Treaty, and the European Parliament and Council's provisional deal on new genomic techniques, which relaxes the regulation of certain gene-edited organisms, both signal a shift in how jurisdictions are approaching the governance of biological resources – with direct implications for ABS compliance strategies.

Osborne Clarke comment

ABS rules are relevant for any company or organisation using genetic resources in research or development. There is no minimum threshold: companies of all sizes may be subject to ABS obligations. Across the EU, many businesses use genetic resources – as a supplier, as a user, or both – for research, development and commercialisation purposes. Pharma, diagnostics, biotech, food, animal health and cosmetics companies may each be affected if genetic resources feature at any point in their supply chain, whether in the form of microbial samples, plant-derived compounds, pathogen materials, fermentation cultures, botanical extracts or associated traditional knowledge.

Where that is the case, it may be helpful to view ABS alongside other compliance topics: mapping where genetic resources or associated traditional knowledge enter the value chain, identifying where and to what extent PIC and MAT apply, and understanding how documentation flows through collaborations and partnerships. Engagement with competent authorities and provider countries, together with careful attention to contractual frameworks, can support both legal certainty and long-term, trusted partnerships in compliance with ABS rules.