Breakthroughs Blog: WHO

Every May for the last 79 years, member states of the World Health Organization (WHO) have gathered in Geneva, Switzerland for the annual World Health Assembly (WHA). The Assembly remains one of the most important moments on the global health calendar, offering insight into how countries are responding to emerging health challenges and where political momentum is building around the future of global health governance, financing, and innovation. This year, however, Geneva felt markedly different. Conversations throughout the week reflected an ecosystem in transition. The global health community is grappling with constrained resources and evolving geopolitical priorities. Meanwhile, WHO reform efforts, persistent budget challenges, and upcoming leadership transitions across multilateral institutions contributed to a broader sense that global health is entering a new phase. Adding to this uncertainty, the United States did not formally participate in assembly proceedings for the first time in WHO's history following its withdrawal from the organization earlier this year.  The assembly also convened amid an evolving Ebola emergency and recent hantavirus outbreak, grounding at times abstract debates about preparedness, coordination, and health security in the realities of active disease outbreaks affecting communities around the world. Against this backdrop, WHA served not only as a decision-making forum but also as a barometer of where global health is headed. For GHTC, three high-level themes emerged that will help shape our advocacy in the months ahead:  1. Innovation must be matched by scale, delivery, and sustainable financing.  Throughout the week, one message surfaced consistently across discussions with WHO leaders, product developers, donors, and civil society organizations: scientific breakthroughs are essential to improving health outcomes, but their impact depends on whether new tools can be produced, financed, delivered, and accessed by the communities that need them most. Today, the challenge is twofold. Continued investment in R&D remains critical to delivering the next generation of vaccines, diagnostics, and therapeutics, particularly for diseases and conditions where significant gaps persist. At the same time, many effective technologies already exist but are not reaching those who need them. Addressing both realities will require increased financing across the R&D to delivery continuum, accelerated regulatory pathways, increased local manufacturing capacity, and more responsive procurement and delivery systems to ensure that innovations are both advanced and translated into impact.  This dual imperative carries particular urgency amid ongoing uncertainty in global health financing. As donors reassess priorities and international institutions face budget constraints, important questions remain about who will finance the next generation of health innovations and ensure their deployment at scale.  Discussions throughout WHA highlighted growing concerns that funding across the entire innovation continuum, from R&D to product introduction, market shaping, and implementation, may not keep pace with scientific advances and need, widening the gap between what is possible and what is accessible. 2. Country ownership is operational, not aspirational.  Perhaps the most significant shift visible throughout Geneva was the growing expectation that countries and regions will increasingly drive and implement their own health priorities.This was particularly evident in discussions marking the first anniversary of the Global Coalition for Local and Regional Production, Innovation, and Equitable Access. Representatives from France, the United Kingdom, the European Union, Indonesia, South Africa, and the African Union repeatedly emphasized the coalition's goal of enabling countries—particularly in the Global South—to become producers, developers, and innovators of health technologies. This conversation reflected a fundamental evolution in how many stakeholders view health security and access: local and regional production is no longer seen primarily as a pandemic preparedness objective but rather as a cornerstone of resilient health systems, economic development, and long-term sustainability. At the same time, discussions throughout the week underscored that manufacturing alone is insufficient; strong regulatory systems are equally critical to ensuring that health products reach communities efficiently and safely. This was reinforced by WHO's newly announced partnership with the African Medicines Agency (AMA) aimed at strengthening regulatory harmonization and reliance, improving safety surveillance, building regulatory capacity, and supporting innovation and local manufacturing across the continent. Similar themes also emerged from GHTC's dialogue with WHO's Prequalification (PQ) team. WHO officials described PQ as an indispensable but ultimately transitional program. The organization's long-term vision is for mature national and regional regulatory authorities to reduce reliance on PQ over time. For that vision to become reality, institutions like AMA and other regional regulatory bodies must develop the technical capacity, regulatory maturity, and trust needed to independently oversee health products.3. AI and emerging technologies are already being deployed.  During WHA week, it became clear that artificial intelligence (AI) and other emerging technologies are no longer hypothetical future solutions, they are already being integrated into health systems and product development. The focus has shifted from how they could be used to how they can be deployed and governed more effectively.  For instance, within WHO's PQ program, the PQ team highlighted the growing use of digital tools and AI-enabled systems to improve efficiency and transparency. Earlier this year, WHO launched its electronic prequalification submission portal, now the mandatory application submission pathway for manufacturers. Looking ahead, the PQ team is exploring how AI tools can streamline product reviews and reduce administrative burdens. Beyond regulatory systems, member states and stakeholders debated WHO's broader role in shaping governance frameworks for AI and digital health as part of the official WHA agenda. While many emphasized AI's potential to boost productivity, discussions consistently returned to concerns of how the organization will navigate challenges in transparency, accountability, data privacy, and public trust.Another major recurring concern was the risk that technological advances could deepen existing disparities if lower-resource countries lack the infrastructure, expertise, or regulatory frameworks necessary to benefit from them. As AI becomes increasingly integrated into global health R&D and delivery, ensuring that these technologies narrow, rather than widen, health gaps will be an increasingly important challenge.Carrying these lessons forward WHA79 underscored that global health is entering a new chapter, one defined by financial constraints, shifting political dynamics, evolving models of partnership, and rapid technological change. Yet amid this uncertainty, one message remained clear: the pursuit of equitable access to health innovation is both a global priority and a shared responsibility. As a coalition, GHTC will carry three priorities forward from Geneva: 1. We will continue advocating for innovation across the full product lifecycle. Investments in research, development, and access pathways must occur in tandem, so new technologies can reach the communities they are intended to serve at scale. For GHTC, this reinforces the importance of maintaining a diverse ecosystem of product developers, manufacturers, implementers, procurement agencies, regulators, civil society organizations, and community leaders to transform scientific advances into public health gains.  2. We recognize the growing emphasis on country ownership and the value of local leadership. As governments increasingly prioritize local production and health sovereignty, GHTC will work to ensure that R&D is a core pillar of these efforts through our Global Partners Network, dialogues with WHO, and engagement in global forums.  3. We will advocate for a future in which all countries have the capacity to contribute to and see their people benefit from the development of lifesaving technologies. Emerging technologies hold tremendous promise for advancing R&D against global health threats. Realizing that promise, however, will require intentional efforts to accelerate R&D, strengthen local capabilities, expand access, build trust, and promote equitable governance. GHTC will support policies that bolster innovation ecosystems worldwide, not only in countries with the greatest resources.The conversations in Geneva made clear that the future of global health will be shaped by parallel progress in innovation and access—driving new breakthroughs while strengthening the systems and local leadership needed to deliver them equitably at scale to the people who need them most. 

Fifteen years ago, the World Health Organization (WHO) issued formal guidance recommending the first WHO-endorsed rapid test for tuberculosis (TB), a landmark shift for a diagnostic landscape that had long relied on slow, labor-intensive microscopy and culture methods. For the first time, high-quality, same-day diagnosis could be possible for millions.Yet the promise of this breakthrough remains only partially realized. Despite major gains, access to WHO-recommended rapid tests has lagged, and many countries continue to depend on outdated diagnostic methods. In 2024, more than 8.3 million people were newly diagnosed with TB, but only around half of them were diagnosed with a WHO-recommended rapid diagnostic test as their initial test. Even more troubling, an estimated 2.7 million people around the world who develop TB remain undiagnosed and untreated.These persistent gaps point to a clear imperative: countries and global health partners must both accelerate access to existing rapid diagnostics and continue investing in the next generation of TB diagnostic tools designed for real-world settings. A new wave of innovative, accessible tools, including a recently recommended class of near point-of-care molecular tests and an emerging generation of digital and artificial-intelligence (AI)-powered screening tools, is now materializing, offering renewed opportunities to close the diagnostic gap for good.New class of near point-of-care diagnostic testsIn early 2026, WHO recommended a new class of near point-of-care tests, nucleic acid amplification tests (NPOC-NAATs), representing one the most significant advances in TB confirmation diagnosis in more than a decade. These molecular tests can detect TB in less than an hour using lightweight, battery-operated instruments that do not require specialized infrastructure for use or storage, making them easily portable. They can be used by health care workers with minimal training in primary health care clinics, mobile units, or community sites, bringing high-quality molecular testing closer to patients, dramatically shortening the time to diagnosis and treatment initiation, and reducing loss to follow-up.WHO now recommends NPOC-NAATs as the initial test for adults and adolescents with symptoms of pulmonary TB or a positive screening result, replacing smear microscopy, which involves the lengthier, more complex and resource-reliant process of collecting sputum (phlegm) samples and preparing them for examination under a microscope in a laboratory. Crucially, WHO also endorsed the use of tongue swabs when sputum samples cannot be collected, improving access for children, people living with HIV, and others who may struggle to produce sputum, who were underserved by previous options.A major milestone came in July 2025, when PlusLife’s MiniDock MTB assay became the first of this class approved by The Global Fund to Fight AIDS, Tuberculosis and Malaria’s Expert Review Panel for Diagnostics, making it eligible for procurement by Global Fund-supported programs. In early 2026, the Stop TB Partnership’s Global Drug Facility announced it would add the test to its portfolio at a low price, further accelerating global access.Additional NPOC-NAAT approvals are expected, which would increase the range of options for patients and drive down prices for governments and procurers, enabling countries to implement these technologies at scale. If widely adopted, NPOC-NAATs could dramatically expand access to high‑quality TB diagnostics, especially in rural and underserved areas where TB can go undetected.Growing number of digital and AI-powered screening toolsJust as a new class of molecular tests are reshaping TB diagnosis, a new generation of digital and AI-enabled devices are transforming TB screening, the essential first step that identifies potentially impacted people who need confirmatory testing. Over the past decade, rapid advances have enabled the development of innovative screening tools that are faster, more accessible, and better suited to the realities of remote and low-resource settings.Portable, battery-operated radiology devices are one tool that has emerged, with various commercial products starting to be rolled out at a larger scale in recent years. These devices can be brought directly to remote communities, improving screening access for hard-to-reach populations.In areas where radiology remains inaccessible, portable, point-of-care ultrasounds are another promising, low-cost solution for TB detection in low-resource settings. The Butterfly iQ portable ultrasound device is currently being evaluated in a large trial in sub-Saharan Africa, where it is being used alongside an AI algorithm that automatically classifies TB-related abnormalities in images captured by the device, helping health care workers faster and more accurately detect TB at the point of care.AI-powered computer-aided detection software has also advanced rapidly, with a growing range of commercial products in recent years. These tools automatically analyze and interpret chest X-rays to identify potential TB cases, expanding the reach and speed of screening programs. Since first recommending AI as a TB screening tool for adults in 2021, WHO has approved six software products for computer-aided detection.Digital stethoscopes are another AI-powered tool—they analyze lung sounds to rapidly screen for pulmonary TB, a solution that can be deployed in community and primary care settings, even by workers without specialized training. AI Diagnostics’ stethoscope and software platform captures high-resolution lung sound recordings and analyzes them using machine learning models, generating a screening result that allows health care workers to distinguish individuals at higher risk of TB. The device is approved in South Africa and is starting to be rolled out more widely.Looking forwardAs TB program budgets globally face growing financial pressures, it is more important than ever to phase out outdated technologies and rapidly scale up next-generation diagnostic tools engineered for broad accessibility. These innovations now emerging, including near point-of-care molecular tests and digital and AI-powered screening tools, represent a pivotal opportunity to close the longstanding diagnostic gap and strengthen TB care pathways.Alongside these efforts, sustained investment in the robust pipeline of new TB diagnostics is also essential to driving continued progress, particularly for solutions that remain understudied: diagnostics tailored for children and other vulnerable populations and treatment monitoring tools to help tailor regimens for people at risk of poor outcomes.With deliberate action and continued innovation, the global community can deliver a better diagnostic ecosystem that meets people where they are and ensures that no one with TB goes undiagnosed or untreated.

Newly shared results from a Phase 3 clinical trial found that a single-dose dengue vaccine was highly effective at preventing severe dengue, as the mosquito-borne disease continues to spread into new areas around the world. The vaccine, developed by the Butantan Institute in Brazil, was recently approved in Brazil for use in people aged 12 to 49 years old. The new trial found that among thousands of participants aged 2 to 59 years old, the vaccine was effective at preventing symptomatic dengue but especially effective—80.5 percent— at preventing hospitalization for at least five years. The World Health Organization (WHO) has shared new guidance highlighting critical targets for new antibiotics, as the global threat of antimicrobial resistance (AMR) continues to grow and outpace the development of new and innovative antimicrobials. The three areas outlined are the development of new drugs to fight Gram-negative bacteria that cause serious infections that are especially difficult to fight; new drugs for patients with serious infections that can no longer be treated with vancomycin, a powerful last-resort antibiotic; and new treatments for bacterial meningitis, which is getting harder to treat due to growing antibiotic resistance. While the research and development of a new antibiotics can be difficult, expensive, and not as profitable as other products, WHO aims to highlight key areas for investors and developers to focus their efforts to grow the pipeline of new, urgently needed tools. Last week, the Sabin Vaccine Institute announced that it has completed enrollment in six Phase 2 clinical trials for its Marburg and Sudan Ebolavirus vaccines in Kenya, Uganda, and the United States, as increasing outbreaks of both viruses in recent years have highlighted the urgent need for vaccines. There are currently no licensed vaccines for protection against the highly contagious, life-threatening diseases caused by these viruses. The Marburg vaccine has also been evaluated during recent outbreaks in Rwanda in Ethiopia. Both candidates have so far demonstrated strong safety and efficacy profiles. The Sabin Vaccine Institute has also begun planning larger Phase 3 trials for each of the vaccines. 

The World Health Organization (WHO) stands at a crossroads—one that could redefine its role in global health and reshape the global health research and development (R&D) ecosystem. In 2025, WHO faced a tumultuous year as several member states—including the United States and Argentina—moved to step back from the organization, citing concerns over its early COVID-19 response and broader calls for reform. These withdrawals, coupled with unpaid dues, have exacerbated existing budget shortfalls and triggered a sweeping restructuring effort aimed at slimming budget and operations, reorganizing leadership, and overhauling the organization’s structure. Yet, how these parallel developments—member states’ retreat and WHO restructuring—are being managed by the health organization remains remarkably opaque. Decisions have unfolded largely behind closed doors, leaving researchers, product developers, regulators, and advocates struggling to understand where responsibilities now sit, how coordination is continuing—or not—and what critical functions may be falling through the cracks. Though WHO leadership has continued to express hope that the United States would reconsider its withdrawal, it is also unclear to what degree informal coordination between these two actors may continue, underscoring the uncertainty facing global health R&D at a moment when clarity and coordination are most needed.WHO plays an irreplaceable role in supporting global health R&D, from setting research priorities and supporting regulatory convergence to coordinating disease surveillance and establishing norms that guide research. As WHO restructures and member states withdraw, these R&D functions risk erosion, creating gaps that could slow innovation, weaken outbreak preparedness, and undermine access to essential health, including both worldwide and in the United States. This blog explores what’s at stake and the unanswered questions that remain. Function at risk: Technical and coordinative support for regulatory bodiesWHO’s research coordination role is reinforced—and amplified—through its technical and convening support for national and regional regulatory authorities. Argentina’s National Administration of Medicines, Food, and Medical Technology (ANMAT), for example, has been recognized by the Pan American Health Organization (PAHO)—WHO’s regional arm for the Americas—as a gold standard Regional Reference Regulatory Authority since 2011. In this capacity, ANMAT has advanced regulatory convergence, capacity-building, and reliance mechanisms across the Americas. Argentina’s retreat from WHO- and PAHO-led regulatory collaboration risks weakening a critical pillar of regional regulatory trust, slowing approvals of quality-assured medical products, and reducing timely access to medicines for patients throughout the region.Beyond regional leadership, WHO’s technical and regulatory functions are tightly linked to how countries approve and adopt new health technologies. Through its prequalification process, which relies on assessments performed by stringent authorities such as the US Food and Drug Administration (FDA), WHO helps countries by assessing product quality, safety, and efficacy more efficiently. In turn, WHO also has come to rely on technical expertise from the FDA and other national regulators. Weakening this symbiotic relationship risks slowing the global uptake of FDA-approved products, diminishing incentives for US innovators to invest in neglected diseases and pandemic threats, and delaying patient access to safe, effective, and affordable health technologies worldwide.  What’s at stake: With WHO’s role as a global regulatory harmonizer in question, will we see an increasingly fragmented regulatory landscape—slowing approvals, duplicating effort, and delaying access to lifesaving products for patients who need them most?  Function at risk: Setting research priorities for clinical and product development WHO convenes scientists, funders, and governments to set global research priorities, align investments, and streamline clinical trials—especially during public health emergencies. This coordination is critical to accelerating the development of vaccines, diagnostics, and treatments for diseases such as HIV, tuberculosis, malaria, and emerging pathogens. In particular, WHO’s development of target product profiles provides an evidence-based roadmap for product developers, helping ensure that new tools meet public health needs, are fit for use in diverse settings, and can interrupt outbreaks before they escalate. Diminishing WHO’s capacity could slow progress across these areas. Efforts may become fragmented or duplicative, and delays could ripple through the R&D pipeline—postponing the availability of lifesaving innovations. In an interconnected global economy, such delays affect all nations by heightening health risks and disrupting supply chains, and they could ultimately impose economic costs on the United States. What’s at stake: If WHO’s R&D programs are undermined, how will global research priorities be aligned and by whom? How will we ensure that scarce R&D resources are prioritized and coordinated to target the most urgent health threats?Function at risk: Disease surveillance and monitoring systems WHO coordinates some of the world’s most critical disease surveillance networks, including the Global Influenza Surveillance and Response System, which informs the development of the flu vaccines used by people around the world, including Americans. Budget cuts, staff reductions, and program relocations could threaten the speed and reliability of outbreak detection, data sharing, and global coordination, making it harder to identify and respond to emerging threats before they spread internationally. Member states that remove themselves from WHO-coordinated surveillance programs put themselves at risk as emerging outbreaks could cross borders and reach countries such as the United States or Argentina before national health authorities have early visibility. What’s at stake: If WHO's disease surveillance programs are hollowed out by member state withdrawals, to what degree will gaps in data and early warning signals delay vaccine development and leave the world less prepared for the next pandemic? Amid sweeping changes at WHO and the growing implications of member state withdrawals, vital questions remain around how and whether WHO can preserve its vital role in the R&D ecosystem. Moreover, there remains little clarity on how the United States and WHO will manage this transition, where critical gaps are already forming. We can look back to the COVID-19 pandemic and see that global health R&D moves faster and more effectively when countries align around shared priorities, pool evidence, and coordinate trials—functions WHO is uniquely positioned to lead. This lack of clarity creates risk: for global health R&D, for outbreak preparedness, and for American health security. WHO will continue its core governance and policy processes in 2026, beginning with its next Executive Board meeting in February. These moments must be used by the global health community to demand greater transparency amid sweeping institutional shifts and to continue pressing for sustained investment in R&D functions that cannot afford erosion. Put simply, if we don’t know what is being scaled back, restructured, or deprioritized, we cannot ensure that the systems that move health innovations from labs to patients remain protected.