Over the past week, at the 79th World Health Assembly (“WHA”) in Geneva, governments have been debating one of the most consequential but still poorly understood elements of the World Health Organization (“WHO”) Pandemic Agreement that was adopted in May 2025: the Pathogen Access and Benefit-Sharing (“PABS”) System. Since then, negotiations on the PABS have continued for one year. On May 23rd, 2026, the WHA adopted a resolution confirming that the PABS negotiations will continue at least up to December 2026 for a special World Health Assembly, and possibly longer.
While the draft PABS Annex has not yet been finalized, it is beyond doubt that once agreed, the PABS System will thoroughly change how life sciences companies access pathogen materials and data; with a significant impact on commercial R&D before and during public health emergencies of international concern (“PHEIC”), including pandemic emergencies.
The implications are not theoretical. While the COVID-19 pandemic is behind us; the recent Andes hantavirus outbreak on a cruise ship triggered international public health response. Then, on May 17th, 2026 the WHO determined that the Ebola Bundibugyo outbreak in the Democratic Republic of the Congo (“DRC”) and Uganda constitutes a PHEIC. This is a new concept under the revised WHO’s International Health Regulations (“IHR”) where a global health emergency is “not quite as bad” as a pandemic but still requires a global coordinated response. Critically, since COVID-19, WHO declarations of either level of health emergency under IHR and the draft PABS would also trigger obligations for companies.
The IHR provides WHO with some obligations to ensure “equitable access” to necessary health products (e.g. by pushing for price transparency or sharing product dossiers). The draft PABS system would go much further. Under the PABS, declaring a PHEIC or a Pandemic Emergency would activate mandatory “benefit‑sharing” obligations for manufacturers of vaccines, therapeutics and diagnostics (“VTDs”). In essence, companies would be expected to e.g. donate free product to the WHO and make certain payments.
This blog examines what that means in practice for vaccine, therapeutic and diagnostic companies. Using recent outbreak responses as a reference point, it highlights the types of events, products, and activities that are likely to fall within the scope of the future PABS System, and why companies should already be assessing their potential exposure.
Link to 1. The Fundamental Principle: Access to Samples or Data Triggers Benefit-Sharing 1. The Fundamental Principle: Access to Samples or Data Triggers Benefit-Sharing
At the 78th WHA in 2025, WHO Member States adopted the Pandemic Agreement. This already established the core architecture of the PABS System in Article 12. While the operational details are still being negotiated in the Annex, the fundamental design of the system has already been agreed. At its core, PABS System is designed to link two elements:
- The rapid sharing of pathogen materials and sequence information by countries through WHO-coordinated laboratories and databases with restricted access; and
- In return, product donations by companies developed from those pathogen materials and sequence information, and possibly sharing a percentage of the profits to support WHO’s pandemic preparedness and response.
In practice, this means that access to pandemic pathogen materials and sequence data is expected to become conditional on companies entering into legally binding agreements with WHO and sharing VTDs.
For companies, this raises difficult financial, legal and operational questions.
Link to 2. What would be the key “benefit-sharing” obligations for Companies? 2. What would be the key “benefit-sharing” obligations for Companies?
Article 12 of the Pandemic Agreement and the draft PABS Annex already provide a clear indication of what companies will be expected to do, although crucial details remain under negotiation.
Link to Product Allocation Product Allocation
During a Pandemic Emergency, companies would need to allocate up to 20% of real‑time production of VTDs to WHO at least 10% as donations and the remainder at “affordable” prices (still undefined). Even during a PHEIC, companies would be expected to provide priority access at affordable prices based on WHO‑assessed public health need. Key elements of this obligation remain unclear, including when the obligation to sign a contract with WHO is triggered or enforced e.g., at marketing authorisation, IP filing, or at time of accessing the samples or data. The concept of “affordable pricing” is also undefined, although some attempts were made during negotiations to place a percentage cap on profits.
Link to Ongoing financial benefit-sharing obligations Ongoing financial benefit-sharing obligations
The PABS System also introduces a requirement of annual financial contributions and potentially additional payments (e.g. milestone or revenue-based contributions) from infectious disease R&D. Certain negotiation drafts saw percentages in the range of 1 – 1.5 %, contributions possibly based on a company’s “use of” PABS materials/data, and its “nature and capacity.” These payment obligations would apply on an ongoing basis, not only during pandemics.
Link to Technology transfer, licensing and IP impact Technology transfer, licensing and IP impact
Companies would also be expected to “choose at least one” option for “non-monetary” benefit-sharing, which would include capacity building, R&D cooperation, and non-exclusive licensing or technology transfer to manufacturers in developing countries.
Link to 3. What will the PABS System cover? 3. What will the PABS System cover?
The PABS System is expected to apply to both physical samples and sequence information of “pathogens with pandemic potential,” that is, pathogens capable of sustained human transmission and of causing a pandemic emergency. However, the precise scope of this concept is hotly debated. Around January 2026, a draft appendix to PABS was circulated that included e.g. Lassa, Cholera, Salmonella, SARS-like respiratory diseases, Ebola Zaire and Sudan (but interestingly, not Bundibugyo) , Marburg, Yellow Fever, Dengue, Polio, AIDS, Chikungunya, Zika, and others.
While the definition points to communicable diseases, its practical boundaries are not fully settled, and no agreed list of covered pathogens has yet been adopted.
Link to 4. How would PABS be enforced? 4. How would PABS be enforced?
PABS does not impose obligations directly under international law. Instead, obligations arise only where companies “voluntarily decide” to enter into legally binding contracts with WHO. The critical component, of course, is whether the “choice” to access pathogenic materials or sequences through the WHO lab and database networks, can be freely made.
The system is therefore built around a form of conditional access: in principle, companies would only be able to access pandemic pathogen materials and sequence data if they agree to the terms of WHO PABS contracts, including benefit-sharing commitments. A major point of contention is whether PABS will adopt a strict “no contract, no access” model – strongly supported by many Global South countries. Under this approach:
- WHO‑coordinated labs and databases would only share materials with entities that have signed PABS contracts;
- Access, use, and benefit‑sharing would be linked through traceability and standardized terms.
The operationalisation of this access-and-contract architecture has long been, and continues to be, a high-priority workstream for WHO. As to the physical samples, the WHO first created the “BioHub” in 2021. This is a Biosecurity Level 4 laboratory based in Spiez, Switzerland, where countries deposit “their” pathogens under strict conditions agreed in Standard Material Transfer Agreements (“SMTA”). These SMTAs then impose further conditions- e.g. whether materials can be used for “commercial” R&D.
As regards pathogen data, negotiations point towards databases that would impose “restricted use” terms when sequences are downloaded by users. This practice is currently already being deployed by the “open-source” database Pathoplexus, the sole platform where Ebola Bundibugyo is currently made available. In that sense, the current Ebola PHEIC is likely to set an important precedent for the future PABS negotiations – with the next meeting planned for July 2026.
Link to 5. What could companies do now? 5. What could companies do now?
Even though the PABS Annex text is not yet final, companies should not wait and are advised to start preparing now by taking a number of practical steps.
- Map exposure to pathogen-dependent R&D – identify which pipelines rely on pathogen materials or sequence data, and assess whether PABS System exposure represents a core business risk or a marginal one.
- Review access pathways and data governance – assess how pandemic pathogen samples and sequence data are sourced, and whether alternative (non-PABS) routes are realistically available. In a potential “no contract, no access” model, access strategy becomes a strategic issue.
- Prepare for production allocation scenarios – stress-test, across manufacturing and supply chains, the impact of possible obligations, including 10–20% allocation requirements, priority supply commitments, and licensing or technology transfer triggers.
- Engage in the policy process – key elements remain under negotiation, including the scope of pathogens covered, the level of financial contributions, and the flexibility of obligations. Companies still have a window to shape the outcome.
PABS is often presented as a fairness mechanism for pandemic response. While life sciences companies are deeply committed to global health, the system, as currently designed, is also likely to create material legal, financial, and commercial risks for infectious disease R&D portfolios. Companies that treat the PABS System as a late-stage compliance issue risk being unprepared.
Engaging now will place companies in a stronger position not only to manage these risks, but also to shape how the system ultimately operates in practice.
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Should you require assistance in assessing your company’s exposure to the new PABS System, or wish to engage in the ongoing negotiations process, the Covington team is available to support you. Please do get in touch with Bart Van Vooren: bvanvooren@cov.com
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Mathilde Raebisch of Covington & Burling LLP contributed to the preparation of this article.