TWN Info Service on Health Issues (May25/02)
16 May 2025
Third World Network

WHO Pandemic Agreement: A Win for Multilateralism, A Missed Opportunity for Public Health?

Analysis by Third World Network (May 2025)

The upcoming 78^th World Health Assembly is all set to adopt the Pandemic Agreement (PA) and to set out modalities for the negotiations of the Pathogen Access and Benefit Sharing (PABS) System, which will be elaborated in an instrument to be annexed to the PA.

While its adoption may be viewed as a symbolic win for multilateralism in a fragmented world, the agreement falls far short of the ambition and solidarity needed to address the stark inequities exposed during COVID-19 and to ensure effective prevention, preparedness, and response to future global health crises.

The draft Pandemic Agreement was finalized after 20 sessions of the Intergovernmental Negotiating Body (INB), held between February 2022 and April 2025, following often tense negotiations marked by sharp North-South divides.

And while the PA is to be adopted by the upcoming WHA (19 to 27 May), it can only be signed and ratified after the PABS Instrument is adopted by the WHA, earliest in 2026.

The INB was set up in 2021 by a Special Session of the World Health Assembly (WHA) following the world’s traumatic experience of COVID-19 which forced WHO Members to rethink the global health emergency regime, especially the lack of equity and solidarity in the context of pandemic prevention, preparedness and response (PPR).

Decision SSA2(5) that established the INB sets out reasons for a PA which includes:

“…address gaps in preventing, preparing for, and responding to health emergencies, including in development and distribution of, and unhindered, timely and equitable access to, medical countermeasures such as vaccines, therapeutics and diagnostics, as well as strengthening health systems and their resilience with a view to achieving universal health coverage”.

It also recognizes the commitment of Member States to develop a new instrument for PPR “with a whole-of-government and whole-of-society approach, prioritizing the need for equity” stressing that development of PA should be guided by “the principle of solidarity with all people and countries, that should frame practical actions to deal with both causes and consequences of pandemics and other health emergencies”.

However, a closer examination of the PA reveals that its ambitious vision remains largely unfulfilled. Except for the proposed PABS system, the agreement relies heavily on ad hoc, voluntary commitments – particularly in critical areas such as technology transfer, production diversification, and equitable access to pandemic-related health products. It is hoped that the forthcoming elaboration of the PABS instrument will yield more concrete measures to address the deep inequities exposed during past health emergencies.

The PA contains three chapters. Chapter 1 on Introduction contains 3 provisions - on “use of terms”, “objectives” and “principles and approaches”. Chapter 2, titled “The World Together Equitably: Achieving equity in, for and through pandemic prevention, preparedness and response” contains 15 articles. Chapter 3 deals with institutional arrangements and final provisions, containing 17 articles.

The key provisions, which were central to the negotiations and often the source of prolonged debate and tension, are highlighted below.

Pandemic Prevention, One Health and Surveillance (Articles 4 and 5)

Article 4 on “pandemic prevention and surveillance” has 6 paragraphs that address (i) progressive strengthening of prevention and surveillance measures and capacities through international collaboration, in bilateral, regional and multilateral settings; (ii) national pandemic prevention and surveillance plans, programmes and actions, such as zoonotic spillovers, antimicrobial resistance, community-level detection, water and sanitation, immunization etc.; (iii) factors increasing risk of pandemics; (iv) provision of mandate to the Conference of Parties (COP) to develop non-binding guidance for the implementation of  provisions under paragraphs 1 and 2 of  Article 4; (v) mandate to COP to facilitate access to resources and tools for prevention and surveillance; (vi) obligation on WHO to provide technical support upon request of Parties for the implementation of the PA.

Article 5 focuses on One Health approach (recognizing the health of people is interconnected with animal health and the environment) for PPR. Paragraph 1 calls on Parties to promote a One Health approach for PPR while paragraph 2 is on Parties taking measures to address drivers of pandemics and the emergence and re-emergence of infectious disease at the human-animal-environment interface by introducing and integrating interventions in PPR plans.  Paragraph 3 calls for measures to promote human, animal and environmental health including by reflecting One Health approach in relevant policies and strategies and multisectoral training and education of the workforce.

Both these provisions (Articles 4 and 5) are framed to provide policy space to Parties to act in accordance with national or domestic laws and based on their national public health priorities. The obligations are subject to availability of resources. In other words, Parties can calibrate the implementation of Articles 4 and 5 by taking into account national circumstances, availability of resources and public health priorities.

These elements have been agreed on following a standoff with developed countries that were pushing for a separate detailed annex that would address “One Health” approach. Facing opposition from the Global South, developed countries then repackaged their demand, and called for an Annex to elaborate on Article 4 on pandemic prevention and surveillance. This suggestion was also vehemently opposed by most developing countries. As a result, the compromise is Article 4 paragraph 4 which provides for development of non-binding guidance.  [For more about the European Union proposal for a One Health Instrument and subsequent negotiations, see here, here and here.]

In future, the COP is mandated to work on means of implementation, in particular for provisions in Article 4, including with full consideration to developing countries taking into account the different capacities and capabilities of Parties (paragraphs 4 and 5).  Despite such a mandate, it is clear from the text of Articles 4 and 5, there is no assurance of additional resources being made available for measures to prevent including surveillance. Any technology sharing provision is subject to “as mutually agreed terms”.

It is also imperative to note that application of Articles 4 and 5 are at the national level and do not obligate cross border transfer such as of biological samples and related sequence data or information relating to public health events. Implementation is also based on national and international laws. Hence crucially caution should be exercised to ensure that conditionalities (rejected during the negotiations and other discussions) are not reintroduced/added when implementing Articles 4 and 5.

Article 9: Research and Development (R&D)

Article 9 promotes collaboration of Parties in R&D with obligations which fall into four areas: (1) building diversified R&D capacities, including in developing countries; (2) encouraging research collaboration and information sharing; (3) clinical trials for pandemic-related products; and (4) publicly funded R&D.

Article 9 focuses on actions by Parties. It does not contain actions for WHO. The provisions outlining Party actions are framed in open-ended language with numerous caveats, creating loopholes that allow non-compliance. Under paragraph 2 Parties are required to promote sustainable investments, research partnerships, access to evidence synthesis, knowledge translation, sharing of information on research agenda etc. all “within means and resources at their disposal and in accordance with national and/or domestic laws and policies”.

Each Party “in accordance with their national or domestic circumstances and law” also undertakes to promote well-designed clinical trials in their jurisdiction during public health emergencies of international concern (PHEIC) and pandemics – by ensuring representative populations, sharing comparator products, and improving access for trial participants and their communities. Parties are also “in accordance with their national or domestic circumstances and law” obligated to “support the rapid and transparent publication of clinical trial protocols”. These as well as other provisions depend on available resources and applicable laws.

Similarly, though paragraph 5 mandates Parties to incorporate provisions in the R&D funding agreements that recipients of funds would have to comply with to facilitate access to pandemic- related vaccines, therapeutics and diagnostics, it does not provide for definite commitments. Instead, it also allows each Party to decide which provisions to include in such agreements.

Accordingly, the paragraph provides a non-exhaustive list of clauses that may be reflected in the funding agreements such as non-exclusive licensing especially to developing country manufacturers, affordable pricing policies, technology access to facilitate R&D and diversify production, and adherence to WHO product allocation frameworks. The approach taken dilutes the effect of the provision as a Party can include minimal commitments in an R&D funding agreement.

Article 10: sustainable and geographically diversified local production

Under this Article Parties are to take measures for three key objectives: (i) achieve more equitable geographical distribution and rapid scale-up production of pandemic-related health products; (ii) increase sustainable, timely and equitable access to such products; and (iii) minimize supply-demand gaps during pandemic emergencies.

Paragraph 2 of the Article requires Parties, in collaboration with WHO and other relevant organizations, to commit to supporting and strengthening national and regional production of pandemic-related health products, especially in developing countries. This includes promoting sustainable manufacturing through skills development, capacity-building, transparency in value chains, and technology transfer. They also aim to incentivize investment and partnerships, support WHO-led production initiatives, and encourage procurement from developing country manufacturers. During pandemics, if existing capacity is insufficient, measures will be taken to rapidly scale up production through additional manufacturing contracts.

However, the commitment under paragraph 2 is qualified to measures “as appropriate” and “subject to national and/or domestic laws”.

WHO is also tasked in sub-paragraph 3 with supporting facilities mentioned in paragraph 2 including through training, capacity building, and timely support for product development, especially in developing countries. Such assistance is only on request of COP, arguably weakening its utility. In contrast, in the recent amended International Health Regulations 2005, WHO can act upon request from “any State Party”.

Article 11: Transfer of Technology and cooperation on related know-how for the production of pandemic-related health products

Article 11 contains six paragraphs, with paragraph 1 having six sub-paragraphs. And yet the provision fails to shift the status quo – technology transfer still hinges on the consent of rights holders, even in pandemic emergencies. The commitments are soft and non-binding.

Paragraph 1 outlines six flexible commitments of Parties such as promoting technology transfer on mutually agreed, taking measures to enhance availability of licenses for pandemic related health technologies, publishing licensing terms for equitable access, encouraging royalty waivers or reductions for developing country manufacturers, promoting technology transfer as mutually agreed to multilateral hubs and encouraging sharing of manufacturing-related information.

“As mutually agreed” is defined as “willingly undertaken and on mutually agreed terms, without prejudice to the rights and obligations of the Parties under other international agreements”.

Additionally, paragraphs 2 to 6 address the following: capacity-building for technology transfer (e.g., absorption capacities); cooperation in relation to time-bound measures agreed in other fora (e.g., intellectual property waivers) to accelerate or scale up the manufacturing of pandemic-related health products; reaffirmation of the right to use to the full TRIPS flexibilities and Parties respecting such use; development or strengthening of technology transfer initiatives; and reviewing national laws to enable implementation.

(TRIPS is the Trade-related Aspects of Intellectual Property Rights Agreement administered by the World Trade Organization.)

This Article was one of the most contentious articles in the PA, which kept negotiations going until the wee hours of 16 April morning. Since the start of the negotiations, developing countries were hoping for concrete commitments relating to transfer of technology. In the end all references to transfer of technology were qualified with “mutually agreed terms”. Effectively technology transfer commitments are voluntary in nature, albeit without prejudice to the right of governments to use measures allowed under international law such as compulsory license to facilitate technology transfer.

Developed countries were opposed to any text that can improve the status quo. For example, with respect to “time-bound measures” developed countries opposed references to cooperation for the “adoption and implementation” of such measures. The text also does not create any new pathways for addressing intellectual property-related barriers to access, beyond providing assurance of the right to use TRIPS flexibilities.

Article 13 and 14: Supply chain and logistics; procurement and distribution

Articles 13 and 14 create a framework for procurement, allocation, distribution and delivery of pandemic-related health products, and supply chain coordination, that is mainly downstream (supply of health products from manufacturer), although upstream (supply of ingredients to manufacturer) elements are also addressed.  While Article 13 establishes the Global Supply Chain and Logistics (GSCL) Network, Article 13bis focusses on procurement and distribution by Parties.

The GSCL Network will be a WHO coordinated mechanism to improve equitable, timely and affordable access to pandemic-related health products during and between PHEICs. 

The structure, functions and modalities of the GSCL Network are to be defined by the COP. Subject to the decisions of COP, the GSCL Network could be tasked with identifying supply sources, barriers, and stockpiling needs; promoting procurement coordination; and ensuring product allocation, distribution, delivery and assistance with utilization including those secured by WHO through PABS system (Article 12).

One of the major concerns with Article 13 is that the functions of the GSCL Network are to be discharged by organizations best suited to carry them out (paragraph 2b). This approach risks creating a fragment pandemic response as well as undermining accountability. The Access to COVID-19 Tools Accelerator (ACT-A) stands as a clear example of how a multistakeholder model can compromise both accountability and effective service delivery. Unfortunately, the INB appears not to have fully absorbed the lessons from the ACT-A experience.

Article 14 is notably weak, containing mostly non-binding language such as “consider” and “endeavour”, offering limited accountability. The only partial exception is paragraph 5, which introduces a relatively stronger obligation for Parties to promote the rational use of health products and reduce waste, with support from the GSCL Network. However, even this commitment is diluted by the qualifier “as appropriate”.

Article 14 contains provisions for each Party to “endeavour” to publish relevant terms of its purchase agreements with manufacturers for pandemic-related health products at the earliest reasonable opportunity and to exclude confidentiality provisions that serve to limit such disclosure.  It also addresses for each Party to “consider” including in publicly funded purchase agreements provisions to promote access to developing countries such as donations, licensing and global access plans. While transparency in procurement contracts is promoted, the provision does not rule out confidential clauses.

The Article also calls on Parties to reserve a share of procurement for countries with unmet needs, but with no defined thresholds. Similarly, Parties should avoid maintaining excessive national stockpiles beyond national need. A provision on sharing products stresses the need for the shared products to have sufficient shelf-life and be accompanied by necessary ancillaries and relevant information.

Article 12: PABS System

Article 12 establishes a WHO Pathogen Access and Benefit-Sharing System (PABS System) for promoting the rapid and timely sharing of “materials and sequence information on pathogens with pandemic potential” and, on an equal footing, the rapid, timely, fair and equitable sharing of benefits arising from the use of such PABS Materials and Sequence Information. Operational details, including scope and definitions, are deferred to a future PABS Instrument – to be annexed to the PA through further negotiations.

Nevertheless, unlike other provisions of the PA, there is clear indication on securing equitable access to health products through legally binding contracts signed between participating manufacturers and WHO. Without prejudice to further detailed benefits to be set out in the PABS Instrument, at least one specific benefit has been reflected in Article 12.

In paragraph 6, each participating manufacturer shall make available to WHO, pursuant to legally binding contracts signed with WHO, rapid access to a target of 20% of their real time production of vaccines, therapeutics and diagnostics (VTDs), with a fixed 10% to be provided as donation and remaining percentage to be provided based on the nature and capacity of the manufacturer, to be reserved for WHO at affordable prices.

Other benefits are reflected in general terms such as VTD access during PHEICs (paragraph 7); VTD access during pre-PHEIC stages of disease outbreak (paragraph 8c), licenses for manufacturers in developing countries to produce VTDs (paragraph 8d) and annual monetary contributions (paragraph 5a). 

The exact modalities of these benefits are expected to be finalized during development of the PABS instrument. Importantly, even though paragraphs 7 and 8 say “including options”, the underlying fact is that access to VTDs under these paragraphs are guaranteed – but through various options. These options are purportedly for maximizing the benefits, by enabling various types of manufacturers to participate in PABS, according to developed countries who insisted on this phrase.

The text is not explicit about the time of signing these contracts, owing to the pressure from developed countries. This will only be settled during the PABS annex negotiations. Similarly key terms such as “participating manufacturer”, “pathogens with pandemic potential”, “PABS Materials and Sequence Information”, and “affordable prices” – are undefined.

Several legal and institutional elements of the system, such as WHO coordinated network of laboratories and PABS sequence database, modalities and legal certainty for access and benefit sharing including standard material transfer and data access agreements, etc., are yet to be designed. Any dilution in these elements will affect the legal enforceability of PABS benefits as well. Fortunately, Article 12 agreed that the PABS Instrument shall also “address” traceability measures along with open access to data (paragraph 3), indicating possibilities for better accountability. 

The relationship between national and international access and benefit sharing laws will also become a critical element in the design of the PABS annex. This is because paragraph (5)(d)(ii) of Article 12 currently risks eroding the national access and benefit-sharing laws of developing countries, by requiring their alignment with a still-unwritten PA annex.

Article 18: Sustainable financing

Article 18 acknowledges the need for sustainable and predictable financing for pandemic prevention, preparedness, and response. Parties are under a soft commitment to maintain or increase domestic funding and mobilize international resources, especially for developing countries. It also promotes innovative financing, including financial reprogramming for countries facing fiscal constraints.

The Article further establishes a Coordinating Financial Mechanism (CFM), but the specifics of its function and power remain subject to future decisions by the COP. Also, the CFM established under the amended International Health Regulations 2005 (IHR) shall be utilized as the Mechanism to serve the implementation of this Agreement, in a manner determined by the COP.

The CFM functions are largely identified as financing gap assessments and developing a five-year financial and implementation strategy for the PA for consideration of COP; promoting coordination of financial pandemic prevention, preparedness and response; identifying sources of financing and maintaining dashboard of such funding sources; and supporting national applications for financial resources for PPR. Essentially the CFM is a mechanism for tracking, mapping, coordinating and advising on financial resources, rather than a fund for financing implementation. A worrying downside of this approach is the likelihood of external agencies undermining the decision-making role of Parties by determining the areas to be financed and therefore prioritised in the implementation of the PA.

Unlike the amended IHR, which mandates the CFM to support the national priorities of recipient states – particularly developing countries – no such commitment exists in the PA. This marks a clear step backward from the recently amended IHR.

On a more positive note, the PA leaves open the possibility for the COP to explore “additional financial resources to support the implementation of this Agreement, through all sources of funding, existing and new” (paragraph 5).  Another potential avenue to influence international financial flows is through the adoption and updating of a financial and implementation strategy. Yet, even here, the commitment is weak – Parties are merely encouraged to “endeavour to align,” as appropriate, with the strategy when providing external financial support.

The implication of Article 18 is clear, financing for implementation of the WHO Pandemic Agreement will largely rely on ad hoc donors and agendas, shaped by geopolitics, and private sector priorities rather than by equity, public health needs or even realization of the objectives of the PA.