On January 17th, 2026, the Biodiversity Beyond National Jurisdiction (“BBNJ”) Agreement, also known as the “High Seas Treaty”, entered into force.  For the first time, companies that use marine genetic resources (“MGRs”) and digital sequence information (“DSI”) originating from areas beyond national jurisdiction may be required to share monetary and non-monetary benefits at a global level.

This marks a significant expansion of access and benefit-sharing (“ABS”) obligations for companies.  Until now, under the Convention on Biological Diversity (“CBD”) and its Nagoya Protocol, ABS obligations applied only to genetic resources originating within national jurisdictions.  The BBNJ Agreement fundamentally changes this landscape: companies in pharmaceuticals, biotechnology, cosmetics, food and feed that rely on marine-derived compounds, microorganisms or genetic data may now face new reporting and annual payment obligations.

Companies should not assume a long transition period.  Implementation is already advancing.  The European Commission has published a draft Directive (“draft EU Directive”), and the United Kingdom adopted the Biodiversity Beyond National Jurisdiction Act 2026 (“UK Act”) on February 12th, 2026. Companies should therefore assess now whether their R&D pipelines, data use practices, or product portfolios fall within scope.

In this blog, we examine how the BBNJ Agreement and its EU and UK implementation could affect companies using MGRs and DSI, and identify the key compliance risks and strategic questions for in-house counsel and senior management.

1. Financial Obligations for Companies

For companies within scope, the BBNJ regime could translate into direct financial contributions, including:

  • Milestone payments tied to stages of research or product development;
  • A percentage of product sales revenue;
  • Periodic, tiered contributions calculated by reference to overall activity or scale of use.

In addition, companies may be required to provide non-monetary benefits, such as:

  • Facilitating access to MGR samples and related DSI;
  • Transfer of marine technology;
  • Capacity-building support for developing States.

The detailed modalities, including contribution rates, calculation methods and triggering events, will be determined at the first Conference of the Parties (“COP”) to take place before January 17th, 2027.  Once agreed, those parameters will be implemented through domestic legislation: the draft EU Directive leaves Member States to operationalize the mechanism in national law, while the UK Act empowers the government to define contributions through secondary legislation.

2. Historic Use of MGRs is in Companies’ Compliance Blind Spot

Because MGRs and DSI historically fell outside most national ABS regimes, companies have rarely retained detailed origin information for marine materials used in R&D.  As a result, many companies may already hold, use or rely on marine materials or data that now fall within scope of the BBNJ Agreement regime – without clear visibility over potential legal exposure.

EU and national impact studies have already mapped the use of MGRs and associated DSI across multiple sectors, indicating that regulators are aware of existing commercial applications, including in:

  • Vaccine and aquaculture research platforms using marine microalgae;
  • Food and nutraceutical products incorporating marine bioactive compounds;
  • Consumer health products containing krill-derived omega-3 oils;
  • Biotechnology and diagnostic tools based on marine-derived enzymes such as luciferase.

Under the BBNJ Agreement, obligations for commercial use are determined by the location of collection.  MGRs collected beyond 200 nautical miles (“NM”) of a coastline fall under the BBNJ Agreement regime, whereas the same material collected up to 200 NM of a coastline remain subject to the coastal State’s ABS regime (where applicable).

3. Retroactive Application Could Affect Legacy Materials and Products

The BBNJ Agreement contains a retroactivity provision under which benefit-sharing obligations may apply to the utilization of MGRs and associated DSI collected or generated before the Agreement entered into force, unless a State Party expressly opts out.  Where a State does not opt out, legacy marine materials or datasets could fall within scope if they are “utilized” after entry into force, potentially affecting existing pipelines and products already on the market.

Several Parties, including the EU and a number of Member States (e.g., Belgium, France, and Spain), have exercised this opt-out.  The UK government has indicated that it intends to opt-out from the retroactivity clause upon ratification of the BBNJ Agreement but has not yet formally done so.  With UK ratification expected before the first COP in January 2027, companies potentially affected have a limited window to engage before the UK’s position is finalized.

4. Scope Uncertainty Due to Unresolved DSI Definition

One of the most controversial issues during the BBNJ Agreement negotiations was how to define DSI.  In the end, no definition was agreed – neither under the BBNJ Agreement in 2023 nor in the parallel CBD discussions.  This leaves a gap for countries to fill.

The draft EU Directive leaves the term undefined.  The UK Act expressly empowers the UK government to define DSI through implementing regulations.  Although the UK Act itself provides no further guidance, the UK government indicated at a stakeholder meeting in December 2025 that DSI could include three progressively broader categories:

  • a narrow definition limited to genomics (DNA and RNA);
  • an intermediate definition extending to proteomics (proteins); and
  • a broad definition encompassing metabolomics and other macromolecules.

The breadth of the definition adopted will be commercially significant.  The broader the definition adopted, the wider the range of R&D activities that would potentially fall within the scope of the new benefit-sharing obligations.

5. Diverging Obligation Triggers

Under the BBNJ Agreement, benefit-sharing obligations are triggered by the “utilization” of MGRs and associated DSI, defined as “research and development on the genetic and/or biochemical composition of marine genetic resources, including through the application of biotechnology.” 

The draft EU Directive adopts the same definition but leaves it to Member States to determine in their national laws, whether downstream commercialization constitutes an independent trigger for benefit-sharing.

The UK Act takes a broader approach and defines “utilization” as both (i) the use of MGRs or DSI  “in carrying out relevant research and development,” and (ii) the “commercialisation of relevant research and development carried out using those resources or that information.” 

This approach treats commercialization as a distinct trigger and captures a wide range of R&D activities.  As a result, activities may fall within scope even where MGRs or DSI were used only as research inputs or tools but are not incorporated into the final product.

6. Practical Consequences for Cross-Border Operations

These differences in trigger design have practical implications for companies operating across jurisdictions.

Under the draft EU Directive, benefit-sharing obligations would primarily be attached at the stage of collection and research and development within a Member State.  By contrast, the UK Act expressly treats commercialization as a trigger.  In practice, this means that the same MGR or DSI could be scrutinized at different stages of the value chain, for example, at the R&D stage in the EU and again at the commercialization stage in the UK.  

If retroactivity applies in the UK but not in an EU member state, this will amplify compliance challenges for a single commercial use. Companies could face cumulative or duplicative benefit-sharing claims in respect of the same underlying marine resource or data, particularly where research, development and commercialization take place in different jurisdictions.

Implementation Timeline

The first formal COP to the BBNJ Agreement will take place before January 17th, 2027, and parties are expected to negotiate more detailed operational rules, including the specifics of monetary benefit-sharing mechanisms.  The outcome of the COP will therefore be decisive in shaping the scale and mechanics of corporate obligations.

At EU level, the European Parliament adopted at first reading its mandate for negotiations with the Council on November 13, 2025.  Trilogue negotiations are expected to follow once the Council adopts its position, with key implementation choices likely to be addressed during this phase.

The UK adopted the UK Act on February 12, 2026.  To date, there is no clear timeline for the UK government’s adoption of the secondary legislation discussed above, although the government has suggested that this may happen by the end of Q4 of 2026.  

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Should you require assistance in assessing your company’s exposure to the new BBNJ rules in the EU and the UK, or wish to engage with the competent EU and UK authorities in the context of ongoing implementation and ratification processes, the Covington team is available to support you.

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Mathilde Raebisch of Covington & Burling LLP contributed to the preparation of this article.

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Photo of Bart Van Vooren Bart Van Vooren

Bart Van Vooren, partner leads a dynamic practice at the intersection of EU regulatory law, global health, and biodiversity law. In these fields, he advises innovative pharmaceutical, food, cosmetic and technology companies on complex EU and global regulatory, compliance and policy assignments.

Bart…

Bart Van Vooren, partner leads a dynamic practice at the intersection of EU regulatory law, global health, and biodiversity law. In these fields, he advises innovative pharmaceutical, food, cosmetic and technology companies on complex EU and global regulatory, compliance and policy assignments.

Bart holds a Ph.D. in EU and International Law and was a professor of EU law until 2013. During that time, he wrote the first-ever handbook with Cambridge University Press on “EU External Relations Law” (2014). He then transitioned to private practice, and frequently acted for the Belgian government before the EU Court of Justice (e.g. C-16/16P Belgium vs Commission). Bart joined Covington in 2016, leading some of our most consequential EU litigation proceedings (e.g. C-311/18 “Schrems II”) over the years.  Having handled nearly 50 cases before the EU Court, he’s uniquely qualified to support our corporate clients in our most high-stakes disputes. Recent examples include T-189/21 Aloe Vera of Europe v Commission (which we won, so the Commission decided to appeal); as well as T-201/21 Covington & Burling and Van Vooren v Commission (which we also won, and hence is also on appeal).

As a pioneer in biodiversity law, over the past 15 years Bart has built a unique, global practice on Access and Benefit-Sharing (ABS) laws under the Convention on Biological Diversity, the Nagoya Protocol, the Plant Treaty, the High Seas Treaty and the WHO Pandemic Agreement. ABS compliance is critical when sourcing biological materials for life sciences R&D and I work with many of the world’s innovative life sciences companies on the whole range of e.g. transactional, contractual, compliance, IP, (EU) regulatory and litigation work relating to ABS. As biodiversity has increasingly become identified as a major commercial and financial risk to companies, so has the practice expanded to e.g. biodiversity credit markets, biodiversity insurance, biodiversity claims and advertising, and so on. Since April 2025, Bart has been appointed as the industry representative to the Steering Committee of the UN Biodiversity Fund that seeks funding from the private sector for biodiversity conservation and restoration.

Bart also pioneered our global health practice. He has advised pharmaceutical clients on seasonal and pandemic influenza since 2016. Since then, this practice area expanded to cover all matters relating to infectious diseases, and as of 2020, emergency preparedness and response (eg. WHO prequalification, International Coordination Group negotiations, Emergency Use Listing, International Health Regulations Rev 2024). He has been the pharmaceutical industry’s lead lawyer advising on the WHO Pandemic Treaty negotiations, adopted on 14 May 2025. Currently, he continues to advise on the work of the Intergovernmental Working Group (“IGWG”) teasing out the technical details of the “Pathogen Access and Benefit-Sharing System” intended to create legally binding obligations on companies to commit vaccines, therapeutics and diagnostics in case of a new global health emergency.

In Chambers rankings, clients have kindly described Bart as “very knowledgeable, action-focused and service-focused lawyer”, adding that he “really tries to find a way of working through challenges”, am “customer-oriented” and provide “sound advice and reasonable options for our business with pros and cons.”

Finally, Bart has an active pro bono practice assisting NGOs defending the human rights of persons with a disability through strategic litigation before the EU Court.

Photo of Yuliya Gevrenova Yuliya Gevrenova

Yuliya Gevrenova is an associate in the Life Sciences Practice Group. She advises clients across a wide range of regulatory, compliance and procedural issues, focusing on EU and Public International law.

Yuliya assists multinational companies in the food, feed, pharmaceutical and cosmetics sectors…

Yuliya Gevrenova is an associate in the Life Sciences Practice Group. She advises clients across a wide range of regulatory, compliance and procedural issues, focusing on EU and Public International law.

Yuliya assists multinational companies in the food, feed, pharmaceutical and cosmetics sectors to navigate complicated legal frameworks, including:

International Health law, including the impact of the WHO Pandemic treaty, the application of the International Health Regulations and the Pandemic Influenza Preparedness Framework.
International Environmental law, including issues of access and benefit sharing under the Convention on Biological Diversity and the Nagoya protocol.
Food law, including labelling and claims; coordination with national authorities during withdrawals and recalls; special rules on flavorings and enzymes, as well as GMOs and NGTs.
Chemicals (REACH, plastics, pollutants, etc.) and Environmental regulations (CSDDD, Wastewater Directive, green washing, etc.).
Animal health issues, including animal testing, transportation and feed.

As part of her pro bono practice, Yuliya advises on complex litigation strategies aimed at defending the rights of people with mental disabilities.

Photo of Seán Finan Seán Finan

Seán Finan is an associate in the Life Sciences team. His practice covers environmental, food and beverage and pharmaceutical regulation.

Seán has specific experience in a number of key areas for EU and UK clients in the technology, food and beverage, pharmaceutical, cosmetic…

Seán Finan is an associate in the Life Sciences team. His practice covers environmental, food and beverage and pharmaceutical regulation.

Seán has specific experience in a number of key areas for EU and UK clients in the technology, food and beverage, pharmaceutical, cosmetic and consumer goods industries, including:

Environmental and ESG compliance issues, including CSRD, CSDDD and green taxonomy issues; green public procurement issues; extended producer responsibility obligations, etc.;
Advertising claims, particularly environmental claims and greenwashing;
General food regulation; novel food regulation; genetically modified and “precision bred” products; and
Chemicals legislation (REACH, CLP, biocides, etc.).

Seán has represented clients in judicial review actions involving novel foods against multiple national regulators.

Seán is qualified in both England & Wales, and the Republic of Ireland.

Seán is a co lead of the firm’s Disability and Mental Health affinity group.