Philip Kenol

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.

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. 

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.