Breakthroughs Blog: WHO

Every year, delegates from around the world descend on Geneva, Switzerland for the annual World Health Assembly (WHA), a convening of key donors, decision-makers, and advocates who are seeking to drive the collective health agenda forward. But while this year offered many of the same lengthy debates, geopolitical outbursts, panel discussions, and late-night receptions, it was clear to all that we are not in normal times.   Global health is facing a moment of profound uncertainty. The financial strain on the World Health Organization (WHO) is just one signal of a wider set of systemic pressures—from donor fatigue to the imperative for countries to mobilize more domestic resources. This year’s forum arrived at a moment when expectations are high, but so too is the risk of backsliding without renewed commitments and smarter, more sustainable strategies. Despite this backdrop, delegates should rightfully celebrate some of the wins that WHO and member states notched this year on behalf of the global community.   Pandemic Agreement is adopted by delegatesIn what was the most anticipated moment of this year’s WHA, member states came together to adopt the Pandemic Agreement—an achievement met with standing ovations and thunderous applause. The moment marked not only a significant step forward for global health but also a rare and much-needed boost for multilateralism.  Deliberations had stretched on for three long years, and until the final moments, it remained uncertain whether negotiators would reach any substantive agreement. But they persisted, driven by the sense that this was a once-in-a-generation chance to ensure the mistakes of the COVID-19 pandemic are not repeated and to lay the foundation for a new architecture and obligations to drive greater equity in the development of and access to medical countermeasures.Notably, this agreement commits countries to develop policies attaching public interest conditions to research and development (R&D) funding—an unprecedented move with the potential to transform how treatments, tests, and vaccines are developed and delivered during health crises.  Additionally, it introduces a new global coordinating mechanism for supply chains and logistics, mandates national policies to ensure post-trial access to products for both trial participants and at-risk groups, and sets out guiding principles for a new Pathogen Access and Benefit-Sharing (PABS) system. Under this system, participating manufacturers would allocate 20 percent of their medical countermeasure production during a health emergency to WHO—supporting more equitable access and distribution around the globe.While delegates celebrated this historic milestone, the process is far from over. Global leaders must still finalize negotiations on the PABS system, which is widely seen by many low- and middle-income countries (LMICs) as the linchpin for ensuring equitable operationalization of the agreement.   More decisions will also have to be made around implementation, especially on financing capacity-strengthening efforts to ensure that countries can meet the new obligations enshrined in the agreement. But for now, many in the community are breathing a major sigh of relief and raising a glass to the successful completion of this arduous phase.   Financing at the forefrontGlobal health is facing a funding crisis as several major donors retreat, leaving many to wonder whether shared global goals and targets can still be achieved. Many major institutions are hindered by a lack of resources, and WHO itself faces an almost catastrophic budget shortfall.   At WHO’s Executive Board meeting in February, member states made the difficult decision to reduce the organization’s budget from $5.3 billion to $4.9 billion for the 2026-2027 period. Subsequently, the secretariat called for an even further reduced budget of $4.2 billion due to the anticipated decline in official development assistance.   During WHA deliberations, member states shared strong views about how the organization’s resources should be allocated. The regions of Africa, the Americas, and the Eastern Mediterranean called for the preservation of in-country work and greater alignment of budget allocations with public health need. In contrast, several donor countries, such as Australia, Canada, Switzerland, and the United Kingdom emphasized the need to safeguard WHO’s normative work, which has predominately been performed at its headquarters in Geneva.   In late April, the secretariat presented member states with a proposal to restructure WHO staff and activities. It recommends that work in Geneva be based around three technical divisions: Health Promotion and Disease Prevention and Control; Health Systems; and Health Emergency Preparedness and Response. The office of the Chief Scientist and the division of Business Operations would provide cross-cutting support. There have also been proposals to reduce the senior leadership team at headquarters from 12 to 7 and consolidate the number of departments from 76 to 34. WHO’s regional offices are finalizing their restructuring efforts as well, aiming to align more closely with the new model for headquarters.  While this plan has been relatively well received thus far, with many country representatives praising WHO for its consultative process, the devil will be in the details. Specifically, it remains to be seen how programs vital to health R&D and infectious disease response will be affected. So far, it is encouraging that WHO is retaining some of its key R&D functions, like the prequalification program and the office of the Chief Scientist. But the impact of the restructuring on disease-specific programs, like tuberculosis, malaria, HIV/AIDS, and neglected tropical diseases, is still unclear.United States makes surprising appearanceFor the first time since 1948, WHA convened without the United States. This absence was acutely felt—not only in the lack of a US delegation in diplomatic deliberations, but also in the ripple effects created across an already strained global health landscape. Nowhere was this more apparent than in the budget negotiations, where the vacuum left by US withdrawal and funding cuts loomed large, injecting uncertainty and apprehension into an already difficult process. Leaders were also thrown for a loop when they received a surprise video message from the new US Department of Health and Human Services Secretary Robert F. Kennedy Jr. In his remarks, which echoed many of the current administration’s previously shared concerns about WHO, Kennedy appeared to extend a bit of an olive branch, calling for “a new era of international health cooperation, free from political influence and corporate bias.” Yet, despite a sprinkling of conciliatory language and even praise for some of WHO’s efforts, he did not give any indication of a shift in policy, nor did he suggest that the United States would consider rejoining the organization at this time.  Secretary Kennedy did acknowledge, however, that infectious disease and pandemic preparedness need to remain national and global priorities, though how the US government intends to forge that cooperation outside of WHO, the Pandemic Agreement, and the International Health Regulations remains unclear.   As we approach the official US withdrawal from WHO in January, it will be interesting to see how the United States will seek to engage in global health dialogues and coordinate with multilateral institutions. The question remains whether the US government will stop the withdrawal or move toward some new framework that allows for limited technical collaboration.   Research takes a back seatAlongside the high-profile discussions on the budget and the Pandemic Agreement, this year’s WHA saw delegates tackle some 75 agenda items during the marathon nine-day session. Yet, R&D—typically a staple of WHA conversations—took a noticeable back seat. Few agenda items beyond the Pandemic Agreement addressed access issues, and virtually none focused on specific product types or infectious diseases. While this may not signal a troubling shift just yet, the innovation community cannot take for granted the need for continued and sustained advocacy to elevate health research as a priority. Even so, the week was not without its bright spots, with new commitments advanced to tackle antimicrobial resistance (AMR) and the impacts of climate change on health and to improve maternal and child health—offering concrete examples of where global health priorities are still gaining ground. Member states unanimously agreed to update WHO’s global action plan on AMR for discussion at next year’s WHA, with several nations underscoring the importance of developing new and effective medicines to keep pace with evolving drug-resistant pathogens. Many countries also offered support for WHO’s Global Strategy for Women’s, Children’s, and Adolescent’s Health, which is aimed at helping reach Sustainable Development Goals 3.1 and 3.2 to reduce maternal, newborn, and under-five mortality rates. Additionally, a new action plan on climate and health was also adopted, which includes R&D-enabling efforts to create stronger links between researchers and policymakers, expand access to financing and technical support, and promote greater cross-border collaboration.   This year’s WHA reflected both hard-won progress and tough realities—and it also set the stage for what comes next. The adoption of the Pandemic Agreement is more than a milestone; it's a mandate to turn consensus into action that advances equity and preparedness. As WHO confronts a reduced budget and undertakes a major restructuring, there's a chance for the organization to streamline, refocus, and emerge as a more agile, effective force in global health. If leaders can build on WHA’s momentum and commit to smarter, more inclusive cooperation, this moment of disruption could mark the start of a leaner and more resilient era in global health.  

The recent staffing cuts at the U.S. Food and Drug Administration (FDA), which affected roughly 20 percent of its workforce, have prompted concerns about the agency’s ability to fulfill its mission. The cuts would severely impact US companies and US global leadership in the biomedical space.  The global implications would be even more grievous—particularly for low- and middle-income countries (LMICs) that depend on the FDA’s regulatory leadership. Many LMICs and other countries rely on the FDA’s assessments, approvals, and post-market surveillance data to inform their own regulatory decisions. These programs, often referred to as “reliance programs,” streamline national approval processes by referencing trusted decisions from agencies like the FDA. As the agency grapples with significant staffing reductions, there could be ripple effects on these international structures.What are reliance programs?Reliance programs allow regulatory authorities in one country to draw on the evaluations, inspections, and approvals of trusted agencies—known as Stringent Regulatory Authorities (SRAs)—such as the FDA. Many LMICs use FDA decisions to streamline access to essential medicines and vaccines, avoiding duplicative reviews and accelerating timelines. This model is especially valuable where regulatory resources are limited, allowing local agencies to focus on post-market surveillance and health care delivery. The FDA’s assessments serve as a de facto quality mark, reinforcing confidence in products worldwide.One example is the World Health Organization’s (WHO’s) Collaborative Registration Procedure (CRP), which enables countries to fast-track the registration of WHO-prequalified medicines by leveraging FDA and other SRA reviews. Between 2015 and 2021, the CRP facilitated 59 approvals for 16 medicines across 23 countries, demonstrating its impact on timely access to quality-assured medicines for patients.Implications for the United StatesIf the FDA’s reduced capacity compromises its ability to effectively conduct timely reviews, update guidance documents, or perform inspections, the most immediate impacts will be felt in the United States. The United States could lose influence in setting international safety, efficacy, and quality standards if other regulatory authorities begin supplanting the FDA's role in global reliance networks. Over time, this erosion of regulatory leadership could diminish the FDA’s status as the gold standard globally—a position that has long bolstered American soft power in global health and trade. Manufacturers based in the United States that are developing products for diseases endemic in LMICs may also find their innovations at a disadvantage if the FDA lags behind other regulators in review speed or capacity or if the WHO prequalification program, which allows US manufacturers to leverage mechanisms that streamline and accelerate the deployment of their innovations in LMICs,  no longer recognizes the validity of FDA review. In 2024, for example, WHO prequalified a Hepatitis C self-test manufactured by Bethlehem, Pennsylvania-based OraSure Technologies. An innovative mpox point-of-care molecular test developed by Sunnyvale, California-based Cepheid became the first such diagnostic ever approved by WHO for emergency use. These FDA-WHO collaborations are vital for the purchase and procurement of American products. If the FDA retreats from this space, it could reduce the competitiveness of American firms in emerging markets and make the United States a less attractive regulatory partner for international collaboration. Preserving the FDA’s global standing is, therefore, not only a matter of public health but also of economic and geopolitical significance.Potential impacts on LMICsHowever, the secondary consequences could be more acute for countries relying on the FDA’s efficiency to inform their regulatory decisions. Delays in product approvals may extend the time before essential medicines reach patients in LMICs—where the burden of disease is often highest and timely access is critical. The loss of experienced personnel and institutional knowledge may also weaken confidence in the consistency and rigor of FDA assessments, prompting some regulators to reevaluate the extent of their reliance. The FDA should build its internal capacity to address neglected diseases rather than reduce staff, providing training opportunities and ensuring their workforce has the prerequisite expertise.Looking aheadTo help safeguard both domestic and global health outcomes, it will be important for the FDA to maintain its capacity to carry out timely, science-based evaluations. One upcoming opportunity to support this effort is the Prescription Drug User Fee Act (PDUFA) reauthorization, which allows the FDA to collect fees from pharmaceutical companies to help fund its drug review programs. PDUFA has long been a bipartisan priority and is key in supporting the agency’s scientific workforce and review capabilities. Ensuring the continuity of this program will help the FDA meet its responsibilities at home and abroad. As global reliance on the FDA remains high—particularly among countries with limited regulatory resources—continued investment in the agency’s capacity will be necessary both for US innovation and global health systems that depend on its leadership.Now more than ever, we must protect the FDA’s ability to lead. A weakened FDA puts American innovation and jobs at risk, slows access to breakthrough products, and opens the door for other countries to set the standards we once defined. The world looks to the FDA, not just for safety and science, but for leadership. With PDUFA reauthorization on the horizon, Congress has a critical opportunity to invest in the FDA’s workforce and secure the United States’ role as the global leader in health and biomedical innovation.

GHTC’s PQ Pulse interview series explores challenges in navigating the World Health Organization’s (WHO’s) prequalification (PQ) program with various stakeholders engaged in the regulatory ecosystem. In our second installment, we sat down with Dr. Iain Barton from Health 4 Development (H4D) and Vizuri Health Dynamics to discuss their experiences with the WHO PQ program in the African continent. H4D is a consultancy firm that specializes in African health system strengthening, market access, and scalable impact for regulatory harmonization across the continent. Vizuri Health Dynamics is an H4D-initiated organization that aims to ensure sustainable and equitable supply of high-quality, affordable medicines across the continent by fostering a competitive pharmaceutical manufacturing sector and empowering African manufacturers.In our interview, which has been lightly edited and condensed below, Dr. Barton discusses H4D and Vizuri’s vision for a harmonious African R&D ecosystem through aligned manufacturers and regulators.  GHTC: In our second installment of PQ Pulse, we’re sitting down with Dr. Iain Barton from H4D and Vizuri Health Dynamics to discuss his experience with WHO’s PQ process on the African continent.  I want to launch right into it and ask our first question. Can you briefly describe H4D and Vizuri’s engagement with the PQ process?Dr. Barton: Vizuri's engagement with the PQ process and the regulatory landscape is first around advocacy. This means bringing the messages of the national regulators and of third-party quality standard authorities to African manufacturers and helping them understand how to engage and how to qualify and position themselves within those spaces. We strive to prompt and help answer the questions: “What are the products? What are the processes? What are the industrial environmental impacts for manufacturers?” The second area of engagement with PQ connects back to national regulators and streamlining processes for WHO-listed authorities around maturity level 3 or 4 [Editor note: A WHO designation for countries with stable, well-functioning regulatory systems]. And so in the development of regulatory reliance structures, we strive to be cognizant of all that is happening, ensuring manufacturers are supported to do cross-border sales, for example, and that they know how to engage with regulators at each level. It’s a difficult and often uncertain space to navigate, and, therefore, the advocacy and education we bring and the enabling of manufacturers we do has probably been the most important role we’ve played around WHO’s PQ structure. GHTC: Yeah, so that's super helpful.GHTC: How has this engagement been shaped by being an African organization in Africa and thinking about the fact that the landscape is evolving and changing? And what are your thoughts on the evolution of that ecosystem?  Dr. Barton: Yes, lots is changing, it really is. It’s cool, it’s very exciting. But it is important that we ensure that everyone comes along on that journey of change. The emphasis on quality and safety is fundamental and must remain the cornerstone. Some things can’t change, and that emphasis on quality and safety is foundational.But it is also important to understand what is changing within the national regulators. Not only what is changing within their own structures, but within regional structures, within cross-regional collaborations around interregional reliance mechanisms, and then in the continental initiative of the African Medicines Agency (AMA) and what that means, both for our national regulators and the manufacturers working within those markets. If you look at the collaboration that is happening now between WHO PQ and national regulatory authorities (NRAs), AMA, and manufacturers, there's an incredible amount of energy going into creating alignment and transparent pathways for those NRAs to integrate with each other and within a much larger system. This is a significant step for African players in supporting not only integrated systems between Africa’s 54 countries but in their integration with the rest of the world. The common goal across stakeholders is to have vibrant African manufacturing capacity that is moderated and enabled by empowered and high-standard NRAs within the AMA structure that is overarching in standards and policy administration. You can start to see why Vizuri being here and acting as that translation layer is so important. The journey from 54 individual regulators to a harmonized, standardized, and reliant regulatory model across the continent is fundamental to achieving that end-vision of a vibrant industry, because it is vitally important to enable manufacturers to not only sell within their own country but also cross-regionally to neighboring countries and even out into the rest of the world. The other thing that’s interesting to watch is how digital tools and technology, in particular artificial intelligence (AI), are being used to expedite processes and create transparency. For example, we’re seeing AI being used to simplify registration application processes. And then also the use of digital tools, and in some cases conversations around blockchain, to ensure that dossiers submitted to this regulator are the same dossiers now submitted to that regulator. Regulatory reliance isn’t just a one-way street; it’s about ensuring the credibility of the applicant as well. So, technology becomes quite an important part in expediting and simplifying regulatory processes. It is important that we continue to accelerate that momentum to reform and enable African manufacturers to adapt to the regulatory landscape as it evolves. And to do this, we have to go together to find new opportunities for funding and collaboration to bring this to fruition. Our current reality is that for many procurements, the third-party regulator is the authority. But we must always live in a place where a third party is also trusted to ensure quality validation, to simplify trade, and to expedite access. There will always be a role for WHO PQ within the environment, I believe, because that trusted third party will fulfill that role across the world. But within Africa, it may diminish all the way to where AMA becomes the overarching validation authority. It’s going to be important that everybody is both willing and engaged in that evolution of the entire ecosystem. GHTC: There are so many exciting things happening and changing in the landscape with the AMA, the Africa Centres for Disease Control and Prevention, and other regional harmonization work for alignment between countries. How does that loop back to the global conversations that are happening or conversations happening in different geographies to ensure that PQ has a role to play? And what would the best-case scenario for what that looks like? Dr. Barton: Yeah, so the stringent regulatory authorities were a closed shop, and that was a method in a system that was completely unsustainable. Stringent regulatory authorities were used as the only means by which anyone could benchmark themselves. And for cross-border trade between regulators, that was the way in which things had to be done. WHO PQ changed that. But then it became another third-party certification process because the people who were paying for the product (i.e., the donors) demanded that third-party validation. As African regulators become recognized for their ability and the quality of their work and the enforcement that they’re able to provide around safety, quality, and efficacy, the need for third-party regulators diminishes. However, until the confirmation of the role of the AMA and the African Medicines Regulatory Harmonization program, third parties like WHO PQ will remain a means by which there’s validation between NRAs. There’s also a vital role to be played in developing trust around African-made products for consumers and practitioners. It’s not only funders that need to trust the product in the public health space—it’s everybody. Everybody always sees WHO PQ as being the way in which funders are able to have confidence in safety, quality, and efficacy. But even more vital as we build a vibrant industry on the continent is the confidence of patients that African-made products are of a high quality. That’s probably the biggest burden that rests on the AMA; over time, the AMA is to become the trusted authority that builds, provides, and maintains confidence across regulators to donors and professionals and, eventually, downstream to patients. GHTC: You’re reminding us of the end goal here to bring new technologies to the people who need them most—practitioners and patients—and the systems that allow them to do that. GHTC: If you had a magic wand that could change the system, influencing the PQ process specifically, what improvements would you make? Broadly speaking, thinking about the integration of AMA with other regulators, what other changes would you make? What would you hope to see five to ten years down the line? Dr. Barton: I guess the clear definition of roles and responsibilities is crucial and for everyone to confidently and assertively pursue perfection in each of their roles in trusted collaboration. For instance, if one looks at the role of AMA, there’s the role of enabling policies and guidelines and expediting the adoption of those policies and guidelines to countries and NRAs. There will always be a need for every product to be registered within each market, because only the local NRAs can hold manufacturers accountable for product quality and drive post-market surveillance and pharmacovigilance for the assurance of product safety in their country. We’re talking about building an accountable system. We want manufacturers in Africa who are accountable for the security of supply of commodities. We want manufacturers in Africa who are accountable for the quality of the product that is delivered to patients. For example, if you have a batch failure on a product that you procured from a manufacturer in China, what enforcement capacity does the national regulator in Malawi have? However, if the manufacturer in Kenya has a batch failure, they can be held accountable by the national regulators, regional regulators, and by the AMA.  And so, when you use that magic wand, the impact you have is different for every different player in the space. The magic comes in an industry that is accountable for security and supply and delivery.They are also accountable for the environmental consequences of their manufacturing processes. We want to see standards around the means of production, in terms of energy use, fossil fuel inputs, solvent utilization, waste management, and water contamination. That accountability can happen in a market that has regulators who are empowered, standards that are homogeneous, and people who invest in those businesses who can access markets across multiple countries, creating an economy of scale. That is the way we will build this vibrant industry. GHTC: That is a great answer, framing the localization agenda through the lens of accountability. Thank you for joining us today to share your perspectives and the work you do with H4D and Vizuri. 

For the first time, global leaders have come together to lay out a comprehensive plan for pandemic prevention, preparedness, and response. After over three years and 13 formal rounds of negotiations, member states of the World Health Organization (WHO) defied expectations and reached consensus on a Pandemic Agreement. The final draft of this legally binding instrument will lay the groundwork for stronger global cooperation and be a major catalyst for a more robust research ecosystem that ensures that the fruits of innovation are more equitably shared.  A win for multilateralism! This agreement is a major win for multilateralism. At times, there were reasons to think the negotiations might fail, including seemingly intractable disagreements between high-income and low- and middle-income countries on access and intellectual property issues. Then came the announcement in January that the United States intended to withdraw from WHO and would take no further part in the treaty talks. International cooperation has been tested, and it was important for the global health community to clear this hurdle.  While the text agreed upon in Geneva reflects compromise and not all negotiators’ ambitions were met, it represents important progress and lays the groundwork for action toward global readiness and equity in future health emergencies.  What’s in it for R&D? Efforts to accelerate the research and development (R&D) of vaccines, drugs, and other medical countermeasures were at the heart of the negotiations, and member states agreed to the following priorities: Promote technology transfer—which involves the transfer of scientific knowledge and know-how from one party to another to facilitate the broader production and availability of products—under “mutually agreed” terms. While this qualifier was disappointing to some low-income countries who had hoped for stronger commitments to help scale up local manufacturing of lifesaving medical countermeasures, it was ultimately a red line for wealthier countries, which prioritized preserving existing intellectual property frameworks.  In a historic first, the text obligates countries to attach conditions for access to publicly funded R&D contracts, a landmark step toward promoting equity. If implemented effectively, this means countries would be empowered to use contract enforcement measures to ensure public R&D spending ultimately results in products that reach patients. An agreement to promote post-clinical trial access to products for trial populations and for populations at risk in their communities, as well as commitments to support the transparent publication of clinical trials protocols and research results.  A framework for a new Pathogen Access and Benefits Sharing (PABS) system that grants companies access to scientific data, such as pathogen samples and genomic sequences, in return for more equitable sharing of drugs, vaccines, and diagnostics during a pandemic. Countries agreed that 20 percent of the vaccines, drugs, and diagnostics produced by participating manufacturers will be made available to the WHO for distribution. PABS wasn’t finalized during the negotiations and will now have to be fully developed through a new working group and added as a separate annex to the agreement. Establishment of a Global Supply Chain and Logistics Network to coordinate resource allocation, reduce access barriers, and mitigate the practice of hoarding of pandemic products through shared stockpiles. Beyond R&D, other key elements of the proposed agreement include a commitment to a “One Health” approach to pandemic prevention, efforts to strengthen national health systems, and the creation of a coordinating financial mechanism to support implementation of new obligations and capacity-strengthening measures.For a more detailed breakdown of the agreement, check out this briefer!Next steps: World Health Assembly and beyond After three years of intense negotiations and significant progress made toward aligning key provisions, critical procedural steps remain before the agreement can be formally adopted and implemented.   First, the text must be adopted by member states at the World Health Assembly later this month. There will then be an intergovernmental working group that will convene to hash out the details of the PABS system, likely over the course of the next year. Once the PABS annex has been finalized, at least 60 countries must ratify the treaty—in accordance with their own national laws and processes—in order for the Pandemic Agreement to become international law and enter into force. Finally, in order to support implementation and ensure enforcement and accountability, a “conference of parties” will be established to regularly review the agreement’s implementation.  The agreement has now reached an important milestone, but the work is not done. Leaders must carry it across the finish line later this month before committing to the task of ensuring its success through robust implementation.