Breakthroughs Blog: WHO

The World Health Organization’s (WHO’s) prequalification (PQ) program plays a critical role in certifying the quality, safety, and efficacy of medical products to expand access to health technologies in low- and middle-income countries (LMICs). In our PQ Pulse interview series, GHTC speaks with stakeholders involved in the PQ process about persistent challenges within this evolving regulatory ecosystem and potential reforms to promote equitable access to innovative medical products.  Our first guest is Pierre Hugo, Vice President of Market Dynamics and Global Supply Security at the Medicines for Malaria Venture (MMV), a nonprofit product development partnership working to advance accessible medicines to treat, prevent, and eliminate malaria. MMV works end-to-end along the research and development pipeline, developing novel products, engaging with regional regulatory bodies, and supporting local manufacturers.In our interview, which has been lightly edited and condensed below, Pierre discusses MMV’s experience navigating WHO PQ and his hopes for the future of the R&D ecosystem.Can you tell us about MMV and the unique role and perspective it brings to product development?We fill the gap and, by and large, are a risk mitigation tool as one of the product development partnerships, or PDPs, within the malaria space to discover, develop, and deliver malaria products. Regarding access, our key ethos is that no drug is a medicine until it's in the hands of the patient. It's all very good and well developing drugs, but if they aren't developed correctly or affordably for the target population and ultimately made available, it's a dead-end game. So, we try to ensure that in the last mile, or the death-mile, drugs are getting to the patients. WHO PQ and organizations like MMV play a very important role.Broadly speaking, how would you describe MMV's experience with engaging in the WHO PQ process?  We’ve got a number of products that are now WHO prequalified, working with our pharmaceutical partners. We see the whole PQ process as a critical mechanism to ensure that quality standards are adhered to and, ultimately, to make quality-assured products available in LMICs, where maybe those regulatory pathways are a little bit less mature. I think what's great to see is that the landscape is changing, with a lot more countries achieving WHO maturity-level 3 status [Editor note: a WHO designation for countries with stable, well-functioning regulatory systems]. Yes, there have been challenges. WHO has been very collaborative, the team has been engaging, and we are grateful for the support that WHO PQ provides.Looking forward, it's going to be critical to see how WHO PQ needs to evolve and change to further strengthen and work more closely with countries’ regulatory mechanisms or pathways.How do you see the regulatory landscape evolving in the coming years, including the potential role of the African Medicines Agency (AMA) and other regional bodies?  The AMA I think is the future; it's critical that it is a success. There's a fair amount of, I wouldn't say pessimism but [questions about] how long it will take for them to be up and running, simply because they just have so many different countries and regional regulatory systems.By and large, the East African collaborative registration or collaborative processes [The Eastern African collaborative registration process is a regional initiative that aims to facilitate the registration of medicines and medical products through a collaborative process, including joint assessments and mutual recognition of regulatory decisions] have been working to some success. There are other regional harmonization networks, but it takes time, and there is still a lot of work that is needed.How do you view recent reforms made to the PQ program? Overall, we are encouraged to see efforts that enable the fast-tracking of innovative product introduction. The new WHO framework for novel products [a reform implemented in 2024 to initiate parallel, rather than sequential, processes for recommending the use of novel products and evaluating them through PQ] is just entering its pilot phase. The new web portal [an online PQ application platform that will provide real-time information for applicants, regulators, and other stakeholders on the status of products in review] will give us greater transparency. The Coordinated Scientific Advice [a new procedure that allows product developers to engage with WHO early on to better understand the evidence that they will need to generate to support PQ review and generation of policy recommendations] should ensure that later review of the finished product is as streamlined as possible.There also needs to be some thought on how AMA will work with the European Medicines Agency, the US Food and Drug Administration, and WHO PQ to avoid complexity for local manufacturers.  If you had a hypothetical magic wand to wave to influence the program, what changes would you make?Something that is critical is to have clarity on timelines and the interaction between PQ and national regulatory bodies and lessons learned. Ultimately, what is the incentive for a manufacturer to go that extra mile to ensure that a product is quality approved [through PQ]? That's where the funders play a critical role in endorsing and supporting the process. Without that support, if you speak to a lot of the manufacturers, they say, “Well, there's no way I'll be going through the WHO PQ process. It's a major investment, and it's an additional long-term commitment that you need to make as a manufacturer.” So, ensuring that there is coordination between normative bodies, funders, procurement partners, and regulators is critical to ensure fast uptake of innovative products.The dream is to have a lot more quality-approved manufacturers in Africa, where over 95 percent of the patient population is. If you look at our new products coming down the line, like single-dose cures or long-acting injectables, greater upfront alignment is key, between WHO PQ and these stringent regulatory authorities, to offer clearer guidance in terms of what those regulatory expectations are for new products. We need to ensure that global procurement agencies, like the Global Fund to Fight AIDS, Tuberculosis and Malaria, the President’s Malaria Initiative, or UNICEF, are working as closely as possible with AMA and with WHO PQ to ensure the rapid uptake of new qualified drugs.I would love to see harmonization between PQ and national regulatory authorities to fast-track important innovation and ensure that new quality-assured drugs get to market faster.Putting on your advocacy hat, where do we, as an advocacy community, need to put our energy in the next couple of years to make some of those improvements become reality?  To unleash the potential [of PQ], we need to simplify the processes for manufacturers, ensure procurement commitments for a clear return on investment, and provide continuous and sustained funding to support manufacturers to embark on the lengthy quality assurance process. If I look at the manufacturers, we did an extensive exercise with the Africa Centres for Disease Control and Prevention to identify manufacturers throughout the whole continent that would want to take malaria products forward to be WHO PQ’d. We only had about 50 manufacturers that were interested in taking part in this initiative [out of 400], so that's a very low number. I mean, we're talking small molecules, not vaccines, and you've got to ask yourself why? They obviously don't see a need to have products WHO PQ’d, which is, on the one hand, a problem. The Africa Centres for Disease Control and Prevention and MMV and other partners believe that the African manufacturing sector can take its place long term alongside manufacturers from India and China, who today supply the vast majority of public health medicines for malaria on the continent.Big Pharma, if anything, is disinvesting in Africa. So, having those in-Africa partners is critical within the malaria space and, obviously, not just for malaria, but for HIV and tuberculosis and so forth.So, I'm just thinking that if manufacturers are going down the WHO PQ route, it might be a really nice carrot to say, “Look, if you are applying for the WHO PQ process, this is a financial incentive in place.” That could be a really nice carrot to keep the Big Pharma guys in the game.

In 2023, tuberculosis (TB) retook the spot as the world’s leading infectious disease killer from COVID-19, claiming the lives of around 1.25 million people that year. Insufficient and inadequate tools and treatments and growing drug resistance have challenged global efforts to bring the TB epidemic to an end. In 2023, approximately 8.2 million people were newly diagnosed with TB, the highest number recorded since the World Health Organization (WHO) began global TB monitoring in 1995. At the same time, global funding for TB diagnostic, treatment, and prevention services fell in 2023 and globally, TB research remains greatly underfunded, with only 24 percent of the $5 billion annual target reached in 2023. Scientists hope that the tide can be turned as new technologies and innovations advance to market—but to achieve that, more investment is urgently needed to boost resources and reverse setbacks. In recognition of World TB Day, test your knowledge of innovations to end TB with GHTC’s quiz: 

The World Health Organization (WHO) has faced tumultuous times over the past few years, and this year’s Executive Board (EB) meeting seemed to bring a chaotic new chapter. Major tectonic political shifts worldwide have plunged the global health organization into serious talks about its long-term funding, sustainability, scope, and ability to deliver on its core mandate.   The EB was anything but business as usual, though member states did their level best to address the political tensions du jour while trying to move through a regular agenda that spanned issues from noncommunicable diseases and maternal and child health to global health security and climate and health. Here are some reflections from a hectic week in Geneva: “We do expect things to change...”  - Assistant Director-General for Business Operations Raul Thomas1. Member states agree to reduce the WHO budget and mostly commit to a 20 percent increase in assessed contributions.In his opening remarks before the WHO EB, Director-General Dr. Tedros Adhanom Ghebreyesus noted that even before the United States and Argentina’s withdrawal announcements, WHO was planning to shrink spending because of a shortfall caused by economic difficulties in many donor countries.  WHO’s budgetary shortfalls overshadowed the first several sessions of the EB, with many member states expressing concern over the sustainability of WHO’s financing in the next biennial budget. Ultimately, a decision was made to lower the program budget to $4.9 billion (from $5.3 billion). Assistant Director-General for Business Operations Raul Thomas captured the general sentiment of EB funding conversations, conveying that WHO’s cash flow is secure for now, but WHO leadership “expects things to change” regarding the viability of the organization’s budget.   However, member states harped over what should change. Many supported a 20 percent increase in assessed contributions—something that members had agreed to at the World Health Assembly (WHA) two years ago—that would reduce the organization’s reliance on voluntary contributions from member states, while others, specifically Russia and China, showed opposition to this plan.   Several member states emphasized the importance of continuing down a path toward sustainable financing through the WHO investment round and developing alternative short- and long-term resource mobilization plans. Member states also urged WHO to distribute information about what the 20 percent increase in assessed contributions would mean for each country. Given the reduced budget, countries insisted on costing all 2025 draft resolutions and decisions prior to any vote during this year’s session.   “It’s back to basics...” - WHO Regional Director for Europe Dr. Hans Kluge2. WHO leadership and member states stress progress and continued need for reform.In the wake of the larger discussions held during the EB about prioritization due to the cash crunch the WHO is facing, there was also a strong focus on the continued need to streamline and reform the organization. WHO Regional Director for Europe Dr. Hans Kluge called for the organization to go “back to basics.” Dr. Kluge emphasized the importance of remaining steadfast to WHO’s organizational mission while being adaptive to emerging threats like antimicrobial resistance (AMR).  Director-General Dr. Tedros also referenced WHO reforms in his opening remarks, acknowledging the significant improvements the organization has made over the last five years, including the newly introduced prequalification framework for novel products. At the same time, Dr. Tedros emphasized the need for continued reform and underscored the importance of engaging in constructive dialogue with member states moving forward.  During the final two days of the EB, member states agreed to several internal improvements and left the door open for further reform discussions at WHA. Citing concerns over its unclear mandate and overlap with other divisions, member states decided to extend by one year the operations of the Standing Committee on Health Emergency Prevention, Preparedness, and Response—which was first established in 2022 to provide guidance and recommendations to the EB and the Director-General on WHO’s emergency response—through May of next year to further evaluate the role of the committee and other similar bodies in health emergencies.  3. Global health security, maternal and child health, and the nexus of climate and health remain key topics.Member states did manage to untangle themselves from WHO’s structural dialogues to fully engage with the more than 47 agenda items on the docket this year.  WHO’s work in health emergencies featured prominently on the agenda once more, though much of the discussion centered around the need to adjust the scope of WHO’s activities. A few member states, including the European Union, Australia, Ethiopia, Finland, and the Republic of Korea, reaffirmed their commitment to the Pandemic Accord, including the then-upcoming negotiations that took place last week, as critical to advancing the prevention, preparedness, and response agenda, including access to medical countermeasures.Dozens of member states shared their appreciation of WHO’s report and draft action plan on women’s, children’s, and adolescents’ health and emphasized their commitment to advancing this agenda item, though Dr. Tedros highlighted that despite progress, “we still have a long way to go.” Equity and access were primary topics of concern for many countries. Several countries also advocated for greater urgency in accelerating efforts for maternal and child health and stressed the importance of intersectoral policies for vulnerable populations. Mentions of research and development were notably absent from the discussion, despite its critical role in addressing gaps in maternal, newborn, and child health, particularly in low-resource settings.  Countries also deliberated the draft global action plan on climate change and health. The plan, which includes some strong R&D provisions, outlines strategic frameworks for building climate-resilient health systems. However, it was surprising to note the absence of the threat of AMR, which is mentioned only once in the document. AMR is poised to cause 10 million annual deaths by 2050 and likely more with the growing influence of rising temperatures and evolving zoonotic diseases. Concerns over cost also dominated the discussion on this agenda item, and several member states, including Malaysia, Bangladesh, and representatives from the Africa Group, highlighted the need to include common but differentiated responsibilities—a longstanding equity principle in climate negotiations that holds historical emitters to a higher bar of responsibility for climate action.4. Civil society engagement continues to be a challenge at the EB.At the tail end of the EB, member states zeroed in on the role of civil society in these debates. While there seemed to be general agreement on the overall usefulness of non-state actor (NSA) statements in WHO proceedings, we did see the continued trend of politicizing otherwise straightforward processes governing NSA access and status with WHO. Member states held a fervent debate over WHO’s Framework on Engagement with non-State Actors (FENSA), which outlines clear criteria and principles for attaining status with the WHO. During the debate, some member states questioned the framework, with representatives from the Eastern Mediterranean and African Regions, as well as China and Russia, all expressing concern over the Centre for Reproductive Rights and Women Deliver receiving status from WHO. The delegate from Egypt captured this sentiment best: “Our reading of FENSA is that it is the foundation and main criteria that we use to accept or reject NSAs — it’s the foundation, but it is not obligatory for member states to accept only on this criteria.”  While on the surface, this debate may appear like an outlier, it marks a broader shift in how some member states are approaching the global health agency, as it has become more commonplace in the last few years to overturn or question established frameworks, rules, and processes at WHO based on national politics. This is especially concerning for civil society, which has seen its ability to meaningfully engage in these forums curtailed over the years.Dr. Tedros concluded the EB by acknowledging the endurance of countries in getting through such a substantial agenda this year and the significance of WHA later this May. While we often talk about the importance of these forums for combatting specific health threats, this year feels like a bigger moment and pivot point for the global health architecture as a whole. Will WHO be able to shoulder the financial blow, make the necessary reforms, and find a way to become more sustainable in its operations? Or will the global health community look back at this moment as the start of the unraveling of the global health ecosystem? Only time will tell.

As 2025 kicks off, we are poised for a year of political uncertainty. There are questions aplenty around the future of US leadership in global health and how priorities will change as the Trump Administration takes office. Canadian Prime Minister Justin Trudeau's resignation and the upcoming elections in Germany may also lead to further policy changes in donor countries historically committed to global health and development. This reshaping of global political dynamics and the lasting impact of emerging infectious disease threats present challenges and opportunities for multilateral collaboration and innovation for global health research and development (R&D) in 2025. As we look ahead at the global health landscape in this pivotal year, here are some of the key issues we are watching. 1. Will the United States fully withdraw from WHO this time?In his very first day in office, President Donald Trump signed an executive order withdrawing the United States from the World Health Organization (WHO), a move that many global health experts agree will make the United States and other countries less safe from infectious diseases and other public health threats. President Trump had previously initiated the process to pull US support from the organization in 2020, but the clock ran out before the end of his term, and President Joe Biden later reversed the decision at the start of his presidency. In the executive order, President Trump outlined his administration’s reasoning for pulling out of the global health agency, decrying “unfairly onerous” payments from the United States compared to other member states and the organization’s “inappropriate political influence.”  The departure from WHO will have dire consequences for global public health, as well as US security, diplomacy, and influence. There are a number of US institutions that collaborate closely with WHO on important work that remains vital to US interests, including polio eradication, cancer prevention, and global health security. US agencies, pharmaceutical companies, and laboratories rely on the WHO Pandemic Influenza Preparedness Framework to gain access to new influenza virus samples for R&D. Severing ties with WHO will impede US access to crucial tools for developing biological countermeasures to influenza.   And WHO’s work extends far beyond influenza. WHO has tremendous reach, working with 150 countries and 70 research institutions in the United States alone. WHO supports the global tracking of infectious diseases, updating networks for polio, measles, and other diseases to provide real-time data for member state officials to guide public health responses. The organization helps facilitate global access to a variety of health products and provides an accelerated path for the procurement of safe, effective, and reliable health innovations. WHO’s prequalification program expands global markets for US producers, offering an accelerated path for approval and uptake of American health innovations in low- and middle-income countries. For example, in 2024, WHO prequalified a Hepatitis self-test manufactured by Pennsylvania-based OraSure Technologies. Lastly, there are concerns about how the US withdrawal will diminish its influence in such a critical global institution. While no major organization is perfect, WHO has chartered a path of reform in recent years, due in large part to US leadership pushing for more effective and efficient governance structures. US concerns will only continue to be addressed if we remain a member state, working with WHO officials and other countries on improvements to the organization. The executive order also calls for broad reassessment and reassignment of American WHO personnel, many of whom play a pivotal role in supporting and directing the organization’s essential work around the world—from responding to disease outbreaks and training local health care workers to classifying disease variants and chairing the WHO Science Council. In fact, there are more Americans in leadership positions at WHO than from any other country. Pulling out of the organization only jeopardizes the United States’ ability to continue to be the most important player in the global health space. 2. Is there enough time to successfully conclude the Pandemic Accord negotiations?A Pandemic Accord could be a game changer in strengthening R&D capacity and creating new frameworks for the development of and access to new medical countermeasures. Reaching a position of solidarity is undoubtedly challenging in an increasingly fragmented world, but if the agreement fails, it will represent a massive failure for global health.   In 2024, countries tried and failed to finalize this proposed international agreement to strengthen pandemic prevention, preparedness, and response (PPPR). Negotiations proved too contentious and the timeline too short to deliver on a new framework. In 2025, countries have one last chance to get it across the finish line. While significant progress was made on reaching consensus on several articles at the end of last year, pain points persist on technology- and knowledge-sharing mandates and the inclusion and operational details of the proposed Pathogen Access and Benefit Sharing system—a mechanism that would facilitate the sharing of pathogen samples and genetic data needed for product development in exchange for benefits like free or discounted contributions of health products.  The Pandemic Accord negotiators held five meetings in 2024, adding up to a total of twelve negotiating sessions held since 2022. And though member states are closer to reaching a finalized text, late last year, negotiators again pushed back their deadline to the 78th World Health Assembly in May 2025. The Executive Order signed by President Trump on January 21 demands that the Secretary of State cease negotiations on the Pandemic Accord and recall and reassign American staff working with WHO; these actions will further disrupt the negotiating process, leaving the United States notably absent from any further discussions.3. How will the G20 and G7 continue the momentum in 2025?  South Africa assumed the G20 presidency late last year, and the question now is how they will build on the momentum of global health progress made under previous G20 presidencies. At the end of last year, South Africa outlined its health priorities, which include accelerating Universal Health Coverage through primary care, strengthening health workforces, combating noncommunicable diseases, and advancing PPPR. South Africa also introduced a science and innovation arm to its global health agenda, committing to review, strengthen, and leverage member state science, research, and innovation sectors.  It will be worth watching whether South Africa builds upon and facilitates the implementation of Brazil’s signature initiative from their presidency last year, the Coalition for Local and Regional Production, Innovation, and Equitable Access, which seeks to strengthen local production to enable more equitable access to safe, affordable, high-quality, and effective health products for neglected diseases.  While South Africa has established an ambitious global health agenda, there is a broader concern that the G20 might succumb to the current tumultuous political climate—France is resettling after elections of its National Assembly last year, the United States has swapped party leadership across the White House and Congress, and Germany has federal elections scheduled for February. With several G20 members undergoing political shake-ups and heavy domestic issues underpinning global conversations, finding member state synergy will be critical this year. And the G7 does not appear to be in a better position after Prime Minister Trudeau’s resignation in early January, as leadership transitions and operational delays will likely sidetrack G7 responsibilities and hamper ambition.  4. Will the financing drum beat fade?This year will also be significant for global health financing. 2025 wraps the seventh three-year replenishment fundraising cycle of The Global Fund to Fight AIDS, Tuberculosis and Malaria. The new WHO Investment Round continues as well, and the World Bank Pandemic Fund announced that its third funding cycle will begin later this spring, shifting from the last two rounds of financing PPPR-related projects to now emphasize support for national and regional health institutions.  Yet, despite the continued need to increase investment in key global health institutions and priority areas, many governments find themselves in constrained resource environments, and around the globe, leaders are pulling back their commitments to provide the necessary funds to address critical challenges like emerging infectious diseases. Mobilizing new funds will be vital for delivering on the Sustainable Development Goals, and 2025 may represent a crossroads on whether countries can sustainably and adequately finance programs, research, and initiatives that boost PPPR.  It is undoubtedly a year marked by change and challenge in global health. As we move into 2025, policymakers, experts, and advocates must navigate an increasingly complex space. The road ahead will require all of us to foster collaboration, embrace creativity, and strengthen advocacy efforts within the global health community. But most of all, it may be the year for the global health community to showcase resilience and forge innovative pathways and partnerships that drive meaningful progress in global health R&D.