Africa Has the Science. Now It Needs to Govern Its Health Data.

When African health ministers gather in Addis Ababa this month for the 76th WHO Regional Committee for Africa, they will make decisions that could shape the continent’s health future. The choices before them range from strengthening research and pharmaceutical manufacturing to ensuring that Africa can govern the health and genomic data that are increasingly central to modern medicine. The continent bears a significant share of the global disease burden, is home to the world’s greatest human genetic diversity, and has a growing community of researchers, innovators and manufacturers committed to improving health outcomes. But Africa continues to underperform in clinical research, pharmaceutical production and health innovation. Fragmented regulatory systems remain a major barrier to translating these scientific and research assets into health innovation at scale, slowing research, complicating cross-border collaboration, discouraging investment and weakening African countries’ ability to govern and benefit from the data generated by their populations.

At the centre of this challenge is the question of who governs the health and genomic data generated across the continent, how those data are used, and whether African countries and populations can share in the benefits of the research they enable. As health research becomes dependent on large and diverse datasets, fragmented national approaches to data governance can make cross-border research more difficult while creating uncertainty around data protection, transparency and equitable benefit-sharing. Strengthening cooperation across African regulatory systems is therefore not only about making research and manufacturing more efficient; it is also about giving African countries a stronger and more coordinated voice in how health data are governed and used.

Clinical research clearly demonstrates the costs of regulatory fragmentation to Africa. The continent bears more than 25% of the global disease burden but hosts less than 4% of global clinical trials, limiting opportunities to generate locally relevant evidence and build research capacity. Harmonized regulatory processes could make multi-country research easier and more attractive. Moreover, the same level of cooperation is increasingly important for governing the health and genomic data generated by such research.

The same regulatory fragmentation affects pharmaceutical manufacturing. Manufacturers operating across African markets must navigate multiple regulatory requirements, increasing costs, delaying market access, and discouraging investment in local production. Greater regulatory cooperation could help create a more predictable market for quality-assured medicines and strengthen the continent’s capacity to produce the health technologies it needs.

The fragmented regulatory landscape is shaping Africa’s future in health and genomic data. Africa possesses the world’s greatest human genetic diversity, but its populations remain significantly underrepresented in the datasets that increasingly shape medical research, drug development and precision medicine. At the same time, fragmented national approaches to health data governance make cross-border research more difficult and raise concerns about data protection, transparency, and equitable benefit-sharing. A coordinated regulatory approach, working alongside frameworks such as the African Union Data Policy Framework and the Malabo Convention on Cyber Security and Personal Data Protection, can help create trusted standards that support responsible research while ensuring African countries retain a stronger voice in how their data are used. As medicine becomes increasingly data-driven, strengthening governance today will help ensure that tomorrow’s scientific breakthroughs better reflect and benefit the continent’s people.

The encouraging news is that Africa does not need to build a new institution from scratch. The African Medicines Agency (AMA), headquartered in Kigali, provides a continental mechanism to address longstanding regulatory fragmentation. Its emerging strategy prioritizes regulatory harmonization and reliance, stronger national and regional regulatory institutions, shared regulatory intelligence, and a more predictable environment for innovation and local manufacturing.

This mandate can also strengthen the governance and responsible use of Africa’s health data. By promoting shared standards, regulatory reliance and greater exchange of regulatory intelligence, AMA can help reduce fragmented national requirements and support more consistent, transparent and efficient clinical-trial and product regulatory processes. Rather than replacing national regulators, it can strengthen their capacity and enable greater cooperation across the continent. What is needed now is sustained political commitment to broaden ratification of the AMA Treaty, secure sustainable financing and fully operationalize the Agency. A strong AMA can become a critical pillar of Africa’s health sovereignty, supporting a harmonized, science-driven and increasingly self-reliant regulatory ecosystem that advances innovation while putting public health impact first.

The decisions taken at the upcoming WHO AFRO Regional Committee meeting should therefore deliver tangible action. With 22 African Union member states yet to ratify the treaty establishing the African Medicines Agency, the work of building a truly continent-wide regulatory system remains unfinished. Completing the ratification and operationalization of the African Medicines Agency, securing sustainable financing and strengthening collaboration among national regulatory authorities would send a clear signal that Africa is ready to build a more integrated and resilient health innovation ecosystem. They are practical investments in better health outcomes, stronger scientific leadership and a future in which African countries play a more decisive role in shaping the medicines, technologies and policies that affect their people.

Africa’s scientific potential has never been the question. The question is whether its regulatory systems can match that ambition. The decisions taken in Addis Ababa will help determine whether African countries can build the regulatory systems needed to support research, innovation, and the responsible governance of the health and genomic data generated by them.

As African experts working across clinical research, research ethics, public health, policy and health systems, we have seen the importance of systems that allow research and innovation to respond to the needs of African populations. What we need now are regulatory systems that match Africa’s scientific ambition and ensure that the health and genomic data generated through research are governed responsibly and in the interests of the people and communities they represent.  

As ministers gather in Addis Ababa, they have an opportunity to move beyond declarations. The 22 AU Member States yet to ratify the AMA Treaty should advance ratification, and all State Parties must ensure the Agency has the sustainable financing and political backing needed to fulfil its mandate. Doing so would strengthen Africa’s ability to translate its scientific assets into better health outcomes while exercising greater ownership over the health and genomic data generated by its populations.


Authors

• Nothando Ngwenya, Academic Lead (Education & Training), Africa Health Research Institute
• Julie Muriuki, Economic Empowerment & Gender Equity Advocate
• Prof. Vinodh Edward, Group Chief Operating Officer, Aurum Institute