Capacity Building

Adopted in May 2025 after three years of intergovernmental negotiations, the WHO Pandemic Agreement establishes a binding international legal framework governing pandemic prevention, preparedness, and response, with emphasis on access to vaccines, therapeutics and diagnostics (VTDs), and technology transfer to the Global South.Reference Villarreal ⁵ Under this multilateral agreement, state parties are required to: (1) strengthen regulatory systems, including through regulatory reliance mechanisms and cooperation to align technical and regulatory requirements; ⁶ (2) adopt policies governing publicly funded R&D arrangements that promote equitable access, including through licensing, affordable pricing, and access-to-technology provisions that facilitate local production; ⁷ and (3) promote and facilitate technology transfer, including through WHO-coordinated technology transfer hubs, particularly for the benefit of developing countries. ⁸

Although the US is not a party to the treaty (and no longer a WHO member state), many African states that have signed BHAs with the US remain WHO members and may still ratify the treaty. These bilateral agreements appear to pull these states away from the multilateral regulatory, technological, and manufacturing commitments embedded in the Pandemic Agreement, replacing multilateral capacity building with a model of dependency on US regulatory authority, US technical standards, and US commercial systems. All eight publicly available BHAs require recipient states to recognize US Food & Drug Administration (FDA) approval as sufficient for domestic regulatory purposes. ⁹ In doing so, they sideline international and regional regulatory institutions, including the African Medicines Agency. Some BHAs also tie market access to commercial conditions without providing access to the regulatory dossiers that would enable local manufacturing scale-up. ¹⁰ At the same time, they embed US technical standards and platforms into the domestic health systems of signing countries, creating infrastructural dependence on US systems instead of strengthening local or regional manufacturing capacity. ¹¹

Instead of promoting independent African regulatory capacity through regional institutions, recipient countries must recognize US FDA approval as sufficient basis for domestic authorization of VTDs. In Kenya’s case, this extends to routine therapeutics and biologics. ¹² This regulatory reanchoring to US policy, as opposed to building domestic capacity, creates a structural dependency on US regulatory determinations across a broad product category, undermining the conditions necessary for the Pandemic Agreement to generate real local manufacturing capacity. ¹³ The South Centre, for instance, has noted that the draft agreement governing how specimens are shared under BHAs does not facilitate product registration in partner countries and provides no access to regulatory dossiers that could support manufacturing scale-up.Reference Syam and Téllez ¹⁴ Such regulatory reliance, when not paired with capacity transfer, risks entrenching long-term dependency rather than building autonomous systems.

Access and Benefit Sharing

The largest structural consequence of the BHAs is that they establish a hierarchy in which US bilateral access could take precedence over Pathogen Access and Benefit Sharing (PABS) obligations. The Pandemic Agreement mandates parties to rapidly share materials and sequence information of pandemic-potential pathogens and equitably distribute associated benefits, including VTDs, based on principles of justice and fairness. ¹⁵

The future multilateral PABS system is currently being negotiated with a view to being finalized as an Annex to the Pandemic Agreement, and its completion by the Intergovernmental Working Group is a formal prerequisite for the Pandemic Agreement to enter into force. ¹⁶ Once finalized, the PABS system may require African states to share pathogen materials through WHO-coordinated systems that link access to medicines to reciprocal benefits; however, the BHAs establish a competing norm, compelling them to provide that same material to the US, potentially before any WHO-governed distribution process could operate. The Liberia BHA, for example, requires the country to provide physical specimens and genetic sequence data of high-consequence pathogens with epidemic potential to US-approved laboratories within five days of detection, for a period of up to 10 years, and provides that each party’s participation in any multilateral agreement governing access and benefit sharing shall not prejudice its compliance with the BHA. ¹⁷

There is no clear reciprocal US obligation to share VTDs derived from the shared materials, no technology transfer commitment, and no benefit-sharing mechanism of any kind, which falls below even the disputed 10% being negotiated through the Pandemic Agreement.Reference Chen ¹⁸ For instance, the data sharing framework supporting the implementation of the Kenya BHA conditions any benefit-sharing arising from insights generated from the shared data and specimens on the conclusion of further subsidiary BHAs. ¹⁹ This approach risks introducing additional unfavorable and potentially inequitable conditions, while also creating uncertainty as to the scope of the parties’ commitments and obligations under international law. Biological specimens must be treated as public resources, requiring clear consent, oversight, and equitable benefit-sharing.

The BHAs replicate the multilateral framework of the Pandemic Agreement by creating a parallel track of biosurveillance and regulatory obligations that might sit above, and in explicit conflict with PABS. The result is a structural constraint on the ability of signing countries to use multilaterally negotiated flexibilities, achieved not through formal treaty revision but through the accretion of bilateral instruments that, individually, appear limited but collectively constitute a governing framework that competes with and displaces multilateral norms. The cumulative effect is to constrain how countries can later exercise rights negotiated in multilateral forums.

These BHAs are being signed while global health law reforms are ongoing: the PABS Annex is still being negotiated, the Pandemic Agreement has not yet entered into force, and the International Health Regulations’ revised capacity building framework is still being operationalized. The US is, in effect, locking African countries into bilateral obligations before the multilateral system has had the opportunity to function, reducing the pool of countries that will negotiate the PABS Annex from a position of unconstrained multilateral solidarity.

Transparency

Finally, limited disclosure and late publication of these agreements will also undermine meaningful public participation and parliamentary oversight, which are central to health governance. At present, the full texts of only eight of the 27 known BHAs signed to date are publicly available. ²⁰ The remaining 19 BHAs are known only through State Department press releases and embassy announcements, which frequently omit critical details on co-investment conditionality, data-sharing obligations, and specimen sharing requirements. ²¹ This opacity is important as a question of principle. Transparency is a central principle in the realization of the right to health.Reference Brigit ²² Decisions that restructure health financing, disease surveillance, digital health systems, and access to medicines affect how states discharge their health obligations. These BHAs will govern billions of dollars in health expenditures, determine the regulatory framework of national medicines authorities, and commit countries to sharing epidemiological data and biological specimens for up to 25 years. ²³ The absence of published texts forecloses the possibility of informed democratic debate within recipient countries, prevents meaningful civil society participation in implementation, and makes it structurally impossible for national parliaments or regional bodies to assess whether the obligations their governments have assumed are proportionate to the benefits promised.

The secrecy is all the more troubling given that Zambia, Ghana, and Zimbabwe rejected proposed BHAs, citing data sharing obligations they described as unfair and one-sided, and the US subsequently threatened to withhold The United States President’s Emergency Plan for AIDS Relief (PEPFAR) funding from Zambia to compel compliance.Reference Acquah ²⁴ Technical cooperation without transparency risks producing systems that are operationally effective but democratically weak, reinforcing extractive dynamics in international affairs.