U.S.-Africa Business Summit 2024: Plenary: Health Regulatory System Strengthening

On Thursday, May 9th, the plenary session on “Health Regulatory System Strengthening” featured a wide-ranging discussion on overcoming resource constraints and regulatory complexity in African health systems. BroadReach CEO, Chris LeGrand opened the session by emphasizing the importance of regulatory harmonization for strong health systems across Africa. Coordinating these systems, LeGrand explained, creates a more investor-friendly climate while ensuring the safety and efficacy of products entering the market, thus delivering better health outcomes for all Africans. He highlighted how BroadReach has partnered with the Gates Foundation to assist with regulatory harmonization efforts and AMA operationalization. Heather Lanigan, USTDA Regional Director for Sub-Saharan Africa, affirmed that harmonization efforts are changing the investment climate. USTDA bases its projects on U.S. company demand; U.S. companies are increasingly asking for Africa programs. USTDA’s Sub-Saharan programs are directed at improving healthcare access through infrastructure, service delivery, and regulatory reform, implemented through grant-based financing and collaborative partnerships. Lawrence Evans, U.S. Pharmacopeia’s Senior Director of Global Health Technical Programs, agreed on the need for harmonization, adding that more than regulatory shifts are necessary: authorities must consider the business incentives for manufacturers as well as the data available for making evidence-based decisions. COVID-19 brought the issue of healthcare security into focus, Evans stated, demonstrating a need for organized, resilient supply chains. Over one hundred countries have adopted USP standards, furthering global regulatory harmonization. Philana Mugyenyi, representing GE Healthcare, drew a distinction between medical devices and pharmaceuticals, calling for “complementary but distinct” regulation. Pharmaceuticals rely on chemical formulas, while the success of a medical device depends on variable human implementation. The comparatively rapid development of new medical devices necessitates regulation that encourages research and development, while pharmaceuticals are threatened by counterfeit products. Nuance, Mugyenyi stated, is key. Noémia Silva Escrivão, Director of ANARME’s Entity Inspection and Licensing Division, seconded the need for a robust regulatory agency. Escrivão described ANARME’s partnerships with regional agencies to share information and develop best practices. Mugyenyi added that while harmonization is an important first step, additional factors such as patients’ ability to cross international borders to access regional hubs, the distribution of care costs, and the sharing of patient records across borders must also be addressed. Evans praised progress in building indigenous manufacturer capacity—both he and Escrivão described progress towards achieving WHO ML3 status, which five African states have reached thus far—but questioned how that capacity translates to procurement. New technology is necessary to reduce production costs, Evans stated, and technology transfers can enable African manufacturers to “leapfrog” in innovation. An additional concern is access to capital, as some manufacturers are turning down investment offers due to currency devaluation. Still, Lanigan noted a 2022 Brookings report valuing Africa’s health industry at $259 billion by 2030 and mentioned that companies will go where the opportunity is—“Africa is where it’s at”—but regulatory harmonization is key to that growth. Evans highlighted an opportunity for U.S. technology transfers to supplement investments by India and China for a stronger system overall. Panelists agreed on the strengthening potential of public-private partnerships. Mugyenyi advocated for both sectors to shift focus from prices to quality, to work together to design new regulatory frameworks, and to leverage innovation opportunities such as using data from medical devices to develop evidence-based policies. Escrivão explained Mozambique’s approach to private business as a partner, working in a transparent and efficient way that benefits public health. Lanigan promoted an upcoming USTDA-CCA workshop on regulatory processes this July in Abuja tailored to that goal. Evans agreed on the opportunities of public-private cooperation, but reminded listeners to keep transparency and accountability in mind. The panel showcased the power of public-private partnerships to strengthen African health systems, but highlighted the necessity of considering all factors that contribute to system success and the importance of the regulatory environment to those efforts. Harmonization requires sustained effort and resources, but is crucial. LeGrand closed the session by thanking the panelists for their efforts in improving healthcare systems across the continent.