Navigating the new UN High Seas Treaty: Key Compliance Risks for Life Sciences Companies
Blog Inside EU Life Sciences

On January 17^th, 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 12^th, 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.

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 17^th, 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.

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).

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.

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.

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.

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.

The first formal COP to the BBNJ Agreement will take place before January 17^th, 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.