Breakthroughs Blog: WHO

A team of chemists from the University of Warwick and Monash University has identified a promising, potent new antibiotic that seems to be much more effective than existing drugs against deadly superbugs like MRSA and shows no signs of resistance so far, encouraging news as the global threat of antimicrobial resistance continues to grow and the pipeline of new antibiotics continues to fall short. The molecule had been overlooked for decades as an intermediate chemical in the natural process to produce another known antibiotic, methylenomycin A, which was discovered 50 years ago, and despite having been synthesized multiple times, the synthetic intermediates have seemingly not been tested before for antimicrobial activity. The new antibiotic is much more potent than methylenomycin A itself—100 times more active against a range of serious bacteria. It could not only be a powerful new tool against rising drug resistance, but this work could also pave the way for new approaches to antibiotic discovery. A team of researchers has developed an antivenom using antibodies from a llama and an alpaca that can neutralize venom from some of the world’s most venomous snakes. Snakebites are a neglected public health issue that kill around 20,000 people in sub-Saharan Africa yearly. Current antivenom treatments are usually specific to a single snake species, and it can be difficult to identify which of the many types of venomous snakes is behind a bite, making timely, effective treatment difficult to achieve. The researchers exposed an alpaca and a llama to venoms from 18 of the most dangerous snake species in sub-Saharan Africa, isolated the antibodies that the animals produced against the venom, and then combined some of those antibodies in a single cocktail. In mice, the treatment protected against toxins from 17 African snake species and reduced skin damage. Many scientists previously thought that developing a broad-spectrum antivenom would require too many antibodies to be practical because some venom can contain up to 100 toxins, but this study shows that a combination of just a handful of antibodies can neutralize the venom of many snake species, paving the way for the development of similar broad-spectrum antivenoms for other areas where snakebites are a common public health challenge. Last week, Cepheid announced that its Xpert MTB/XDR test for tuberculosis (TB) drug resistance has been prequalified by the World Health Organization (WHO), enabling procurement through international agencies and greater access in areas with a high TB burden. The test is designed to detect resistance to multiple first- and second-line TB drugs from patient samples. It also delivers results quickly, within 90 minutes, allowing health care providers to make quicker, more reliable treatment decisions and have a better understanding of drug resistance, especially in regions with a high TB burden where timing and accuracy are critically important. 

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 third installment, we spoke with Dr. Benjamin Djoudalbaye, head of the African Medicines Agency (AMA) interim secretariat, to discuss the agency's role in advancing regulatory harmonization across the continent and its intersection with WHO's PQ program.   In our interview, which has been lightly edited and condensed below, Dr. Djoudalbaye discusses his vision for a harmonious regulatory system across the African continent.   GHTC: To begin our conversation today, it would be helpful for you to outline AMA’s scope and highlight its current status.  Dr. Djoudalbaye: Yes, thank you for the question, and thank you for the opportunity for AMA to tell its story.  AMA is a specialized agency of the African Union, established to regulate and harmonize oversight of medicines, vaccines, medical devices, and veterinary and traditional medicines across the continent. The overarching goal of the agency is to ensure that all Africans have access to high-quality, safe, and effective medical technologies.   This is a quite broad definition of AMA, as it also has some specific key functions. These include regulatory harmonization across African regulatory bodies, assessing and listing medical products, pharmaceutical manufacturing, market surveillance, and supporting growth of local manufacturing in alignment with the African Pharmaceutical Manufacturing Plan. Oversight of clinical trials and good manufacturing practices also fall under the purview of the agency. I named just a few functions of AMA, but there are many more.In terms of governance, AMA is established by a treaty that is undergoing ratification and is currently endorsed by 31 countries. A Conference of State Parties has been established to oversee it, in addition to a governing board and secretariat. Dr. Delese Mimi Darko was appointed as AMA’s Director-General and will assume her role very soon at the agency’s headquarters in Kigali, Rwanda. My role consists of laying the foundation for Dr. Darko to take over and lead the institution. GHTC: That’s helpful context to gain an overview of AMA. It’s also exciting to see how much progress has been made to operationalize the agency in such a short among of time. GHTC: How do you see AMA’s role evolving as it relates to PQ, potentially as a partner and/or taking ownership of certain functionalities?Dr. Djoudalbaye: That’s an interesting question and one that I do not have all the answers to. AMA has not given an official position on its relationship with WHO PQ, but I can provide a few ideas on how that might play out.  To me, PQ has long served as a global benchmark for ensuring the quality, safety, and efficacy of medical products, particularly for [low- and middle-income countries] that lack robust regulatory systems. Africa has gotten support from this program’s rigorous assessment of medicines, diagnostics, and vaccines for products procured by [UNICEF] or by Gavi, the Vaccine Alliance, as those products must be prequalified by WHO before they are procured and then delivered. So that’s one way PQ and AMA will continue to engage with one another. We also need collaboration for quality control of health technologies, which is WHO PQ’s guaranteed service. Providing technical support and training to national regulatory authorities, specifically guidance for local manufacturers seeking to achieve international quality standards, is another area of expected engagement with WHO.  AMA is positioned to harmonize and coordinate Africa's network of quality control laboratories and build on platforms developed through PQ. So, in this regard, PQ is extremely important, and AMA needs to build on that. Despite the progress we see with AMA, we need to recognize the continent’s reliance on national and regional regulators. On the continent today, we have three layers. Layer one is the continental level, of what AMA will do and implement; the second is the African Medicine Regulatory Harmonization program, working alongside regional economic initiatives; and the third layer is the national level. It is important that these layers communicate with one another as they transition from reliance to recognition. Further down the line, we can think about leveraging the WHO Foundation to develop an Africa-specific or fast-tracking product assessment system that focuses on regional health priorities and locally manufactured products as a possible idea. Long-term, my goal is for AMA to decrease Africa’s dependence on external prequalification.GHTC: Yes, I agree. It’s hard in this environment to make any sort of clear determinations with all that is moving around us, especially with WHO’s reform, as well as changes in the US landscape.  GHTC: What challenges are you facing day-to-day? How do you ensure that you continue the forward momentum, as AMA is undergoing ratification?  Dr. Djoudalbaye: One challenge is the fragmented regulatory frameworks across the African continent, and it will be AMA’s role to coordinate and bring those stakeholders together. The diverse—and sometimes conflicting—regulations across countries and regions make it difficult for manufacturers to comply effectively, especially for those working across jurisdictions. We have countries with different national languages, which can also make alignment difficult. One united framework will help address bottlenecks, reduce approval times, reduce markets to entry, and bring down administrative costs.  Another challenge is bureaucratic inefficiencies. Complex, opaque regulatory procedures increase operational costs, discourage investments, and create barriers to scaling innovation. The issue may be—and I am choosing my words carefully here—perceived corruption and inconsistent regulatory enforcement in some countries that can erode trust in the system.Inadequate regulatory oversight is another pain point. Many regulatory authorities lack resources and capacity, and that is a contributing reason to why we only have eight African countries that have achieved maturity level three [Editor note: WHO has a four-level system for assessing the strength and functionality of national regulatory authorities]. We are striving to have at least half of Africa’s member states reach maturity level three, others to reach four, and even potentially have regional bodies added as WHO-listed authorities [Editor note: WHO-listed authority is a designation for countries with stable, well-functioning regulatory systems]. Policy integration and public-private collaboration are other areas to improve. In terms of integrated policy development, we need to encourage cross-sectional policymaking alignments, bringing the industrial, science, and trade sectors closer to create a coherent investment in the regulatory environment. Engaging private-sector voices in shaping regulatory reforms is important to innovating technology, developing skills, and modernizing regulatory technologies. For instance, we can fast-track product entry into the market by leveraging blockchain technology in regulatory affairs to expand training, technical education, and international partnerships like WHO PQ. Inconsistent adoption of international standards is another issue. There are disparities between local regulators and international standards that complicate compliance and block access to global markets, especially in high-growth sectors, such as pharmaceuticals and food processing.  Finally, trade barriers have emerged as another bottleneck. Persistent non-tariff barriers and the slow implementation of agreements like the African Continental Free Trade Area restrict intra-African trade and regulatory harmonization efforts.  So how do we overcome these challenges? We need regulatory reforms and harmonization to streamline bureaucratic processes from regional regulators to continental ones, like AMA. This will make it easier for businesses to expand across borders and tap into larger markets.  GHTC: This is a great transition to our last question: what do you envision for AMA as an agency for the next five to ten years?  Dr. Djoudalbaye: In the next five to ten years, I want to see AMA poised to become a cornerstone of Africa’s health regulatory landscape and shape the continent’s access to safe, effective, and high-quality medical products. We must also eliminate substandard and falsified products, and I see that as an avenue for a quick win for the agency. Overall, AMA’s emergence will signify a unified and collaborative regulatory framework that is vital for the continent.  Decentralization and harmonization are important to continental regulatory leadership. This will also strengthen national agencies, so we need to build capacity at the continental, regional, and country levels. However, AMA cannot solve everything. Integration of these levels will be essential for the scientific capabilities of the agency. I want to see AMA as a high-quality and independent organization, so its regulatory decisions are evidence-based and preserve scientific integrity.  GHTC: Thank you for your time, your insights, and your proposed solutions. 

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.