Breakthroughs Blog

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.