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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. 

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign up now to receive our weekly R&D News Roundup email. A new study found that LC16m8, an attenuated vaccinia virus strain originally developed in Japan for smallpox and later approved for mpox in 2022, induced strong responses and was safe in mice, monkeys, and healthy adult humans, potentially paving the way for the development of broadly effective mpox vaccines. The researchers vaccinated mice with LC16m8 to see how it protected them from mpox, later vaccinating monkeys and healthy adult volunteers as well to study their blood samples for immune responses and monitor them for safety. The results underscore LC16m8’s potential as a safe, effective, and scalable choice for mpox vaccination and also provide a blueprint for developing next-generation vaccines against other poxviruses and emerging pathogens.Researchers from Abertay University and Bangor University have developed a prototype blood test that can detect up to five infections at the point of care, providing results quickly via a smartphone app. The tool, which was piloted using tuberculosis as a test case, showed high sensitivity and an ability to accurately identify cases. The speed and convenience, as well as the much lower cost compared to lab testing, demonstrate the test’s potential to be a game changer in ensuring access to timely testing and diagnosis, particularly in remote locations and other settings lacking laboratory infrastructure.  The results of a Phase 3 clinical trial published last week found that Moderna’s combination COVID and flu shot outperformed existing individual vaccines for both viruses. The combination shot uses the same mRNA technology as Moderna’s approved vaccine for COVID-19, but there are no currently approved mRNA flu vaccines. In a trial that included more than 8,000 adults, the combination vaccines generated higher antibody levels for COVID and all but one influenza strain in trial participants who got the combination vaccine compared to those who got individual vaccines. A combination vaccine could help boost vaccination levels for both viruses, and an mRNA vaccine, in particular, could also speed up production because they are faster to make than current flu shots.

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.