Image Credit: World Health Organization

On 16 April 2025, Member States of the World Health Organization (WHO) concluded negotiations on a new international treaty: the Agreement on pandemic prevention, preparedness and response (“WHO Pandemic Agreement”). Set to be adopted at the May 2025 World Health Assembly, this landmark accord aims to improve pandemic preparedness and response. While binding only on states, the treaty includes a broad set of provisions that will have direct and indirect implications for companies across life sciences and adjacent sectors. Below, we unpack key aspects of the treaty most relevant to businesses, especially manufacturers and developers of “pandemic-related health products.”

1. What is the WHO Pandemic Agreement?

The Agreement is a treaty under Article 19 of the WHO Constitution with 37 articles across three chapters, aiming to resolve some of the global challenges seen during the COVID-19 pandemic. It addresses disease surveillance, health systems resilience, One Health, R&D, local production, technology transfer, company payment and donation requirements to WHO, public procurement, global supply chains, and a financing mechanism. Its provisions apply at all time—not only during health emergencies.

2. Does the Agreement apply to companies?

While the Agreement itself will only bind states that decide to ratify it, its mechanisms will materially affect companies—particularly those involved in the development, manufacture or distribution of “pandemic-related health products.”  They are defined in draft Article 1(d) as “relevant health products” that “may be needed” for prevention, preparedness and response to pandemic emergencies.  That article cross-refers to the amended International Health Regulations (IHR) that defines relevant health products as “those health products needed to respond to public health emergencies of international concern, including pandemic emergencies, which may include medicines, vaccines, diagnostics, medical devices, vector control products, personal protective equipment, decontamination products, assistive products, antidotes, cell- and gene-based therapies, and other health technologies.”

3. When will the Agreement enter into force?

The main treaty requires 60 ratifications to enter into force. However, an additional technical Annex to the main treaty, on the so-called “Pathogen Access and Benefit-Sharing System” (PABS – see below) still needs to be negotiated.  Countries hope to conclude negotiations on the PABS Annex by May 2026. However, we think that is ambitious and consider May 2027 more likely, possibly even 2028.   Subsequently, it will take a few years to reach 60 ratifications, so that the WHO Pandemic Agreement will not likely into force before 2029. What is clear, however, is that the main Pandemic Agreement and the PABS Annex are considered a package deal. For that reason, the main Pandemic Agreement will not be opened to ratification until the PABS Annex has been finalized.

4. What is the PABS System and why does it matter?

The PABS System links companies’ access and/or utilization of pathogen samples and sequence data with benefit-sharing obligations. Companies accessing materials through PABS may be expected to:

  • Pay contributions to WHO
  • Contractually commit to providing a percentage of pandemic-related products to WHO in case of a pandemic, with a target of 20%, of which 10% is a donation.
  • Possibly agree to non-financial benefit-sharing (e.g. tech transfer, licensing)

These commitments will be enforced via contracts concluded between WHO and the companies, and parties will be expected to align their national ABS laws with the Pandemic Agreement.

5. Will companies be required to transfer technology?

No. Article 11 of the Agreement sets out six measures that states “shall” undertake, “as appropriate,” to enable sustainable and geographically diversified production. Crucially, the transfer of technology is defined in a footnote as action that must be “willingly undertaken and on mutually agreed terms.”

This language—”willingly undertaken”—was a hard-fought compromise and ensures that technology transfer will not be compulsory but remains voluntary. That said, there is a political expectation that technology transfer should occur. Companies should interpret this as a push toward more structured, potentially conditional engagement on IP licensing and know-how transfer, particularly where public R&D funding or collaborative research is involved.

6. How does public R&D funding tie in to the WHO Pandemic Agreement?

Article 9 requires countries to include equitable access conditions in publicly funded R&D contracts—particularly those involving private entities or PPPs. These may include:

  • Affordable pricing and global access commitments
  • Non-exclusive licensing
  • Technology transfer requirements
  • Adherence to WHO product allocation frameworks (e.g. via the GSCL Network)

In effect, companies receiving public research funds may be indirectly bound to WHO guidelines and international equity objectives.

8. What about procurement and supply chain obligations?

The Agreement creates a Global Supply Chain and Logistics Network (GSCL) to be coordinated by WHO and overseen by the Conference of the Parties. Countries are encouraged to:

  • Avoid excessive stockpiling
  • Publish terms of public procurement contracts
  • Include access-promoting clauses (e.g. donation, licensing)

This could further restrict the ability of companies to negotiate confidentiality and exclusivity in future pandemic APAs.

9. What is the Intergovernmental Working Group (IGWG) and why does it matter?

While the main Agreement text has been finalized, the critical operational details—especially those concerning the PABS System—will be developed by an open-ended Intergovernmental Working Group (IGWG). This group is scheduled to begin work by September 2025, supported by a technical expert committee by June 2025.

The IGWG will shape key questions such as:

  • Which pathogens are covered by PABS?
  • What triggers a benefit-sharing obligation?
  • Will the same rules apply to sequence data and physical samples?

Companies should monitor this process closely and engage to avoid overly burdensome or unclear compliance obligations.

10. What should companies do now?

The WHO Pandemic Agreement is not as ambitious as originally set out and contains a range of political declarations and aspirational legal commitments.  Moreover, the ongoing financial constrains and broadening responsibilities of the WHO continue to raise significant question marks of the Agreement’s impact.  Nevertheless, it remains a milestone for pandemic preparedness, and will no doubt shape companies’ environment for infectious disease innovation broadly defined.  As regards action points, we consider the following next steps are advisable:

  • Continue advocacy in the next phase of negotiations to ensure that PABS and future national implementation supports the enabling environment for innovation.
  • Map product portfolios against the broad definition of “pandemic-related health products” to assess potential impacts on e.g. compliance, manufacturing, supply chain, know-how.
  • Monitor IGWG negotiations on the PABS Annex and push for a clear and workable system, including on e.g. definitions of covered pathogens.
  • Be on the look-out when concluding public funding, R&D, and procurement contracts for embedded equity conditions.

Covington continues to closely monitor the WHO Pandemic Agreement and its implications for global health product developers. Contact us for guidance on how to prepare for implementation and manage risk exposure.

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.

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