Leadership training empowers Africa’s health regulators
- Wits University
The new African Regulatory Leadership Programme (ARLP) is a step towards regional harmonising and establishing the African Medicines Agency.
Held at the Wits Business School, the continent’s top national health products regulators gathered in Johannesburg last week to advance their leadership skills and mutually map out how Africa can strengthen its regulatory capacity. This comes at a critical juncture in light of global funding cuts and the prevalence of substandard and falsified medicines.
Professor Helen Rees, CEO of Wits RHI, highlighted the importance of African regulators in ensuring regional and national health product safety. “A new generation of regulatory leaders are now contributing to regional harmonisation efforts and supporting the establishment of the African Medicines Agency. The focus until now has been on technical milestones, but we recognised the need for the personal growth of these regulatory leaders, hence the establishment of the ARLP.”
Wits RHI, the Health Regulatory Science Platform (HRSP), and Supporting Health Initiatives (all three are divisions of the Wits Health Consortium), in collaboration with the Harvard T.H. Chan School of Public Health, established the first ARLP training, inspired by the Harvard Ministerial Leadership Programme.
A significant leap in regulatory maturity levels
In 2018, only one country, Tanzania, had achieved maturity level 3 (ML3) in terms of health products regulation. In 2024, eight African countries had achieved this, meaning that their national health regulator was stable, well-functioning, and integrated. The World Health Organization (WHO) benchmarks the regulatory systems of a variety of product types, including medicines, vaccines, blood products and medical devices.
Ghana, Zimbabwe, Senegal, South Africa, Tanzania, Nigeria, Rwanda and Egypt have achieved ML3 status. (The highest attainment is ML4, which signifies an ongoing commitment to maintain an already advanced regulatory system. Several African countries are already on the path to achieving this.)
“ML3 is only achieved by a few countries globally and highlights that more African countries can be awarded this. Moreover, the ARLP can encourage those already at ML3 status to become WHO-listed authorities for certain product streams, like medicines or vaccines, and regulatory functions,” said Hiiti Silo, the Unit Head of Regulation and Safety at the WHO and a member of the ARLP’s teaching and mentorship faculty.
Collaboration: The key to a stronger regulatory future
ARLP faculty member and Principal Policy Specialist at the Africa Union Development Agency (AUDA-NEPAD), Chimwemwe Chamdimba, says that achieving MLs 3 and 4 requires reliance and collaboration. “It’s why we gathered many national regulatory authorities (NRAs) in one room. We need a cadre of experts who have the leadership skills to promote regulatory harmonisation, convergence, networking, and work sharing. We can’t do this alone.”
Emer Cooke, sharing her experience as the Executive Director of the European Medicines Agency, noted that no matter the differences (size, economy) among member states, there can be a single market for pharmaceuticals. “This is possible because we work within a system of reliance and recognition across the European Union. There needn’t be 27 separate scientific assessments to authorise a medicine. Our standards are all the same.”
Already, AUDA-NEPAD and the Africa Centres for Disease Control and Prevention (Africa CDC) signed a memorandum of understanding among Africa’s WHO ML3 national regulatory authorities. “Not only does this foster collaboration, but it propels an enabling environment for the local production of medical products. We cannot have our own manufacturing capacity if we don’t have regulation in place,” said Chamdimba.
Precious Matsoso, director of the HSRP, former director general of the National Department of Health and current co-chair of the WHO Intergovernmental Negotiating Body, explained to programme participants that the ultimate aim is to ensure health equity and access in Africa. Robust systems need to be in place for that. This will then assist the African CDC in responding swiftly to public health processes. “Our regulatory processes, with strong leadership behind these, are the cornerstone. We must make sure that medicines, vaccines and diagnostics are accessible to people who need it the most.”
Participants and faculty members concurred that harmonising healthcare across the continent is key to increasing Africa’s overall commitment to health equity and access. “It is why the ARLP is a targeted training programme to build resilient health systems and secure a sustainable future for the continent. And after the stop work orders from the US, the leadership training is timely indeed,” said Robyn Hayes Badenhorst, the co-executive Director of Supporting Health Initiatives (SHI).
Matsoso also wants to debunk that the African health regulatory processes have little capacity. “We also recognise that for anything to happen, we need to have leadership. We invited the heads of the regulatory authorities to gather and share their experiences and hopes. It’s essential to add that this is not only about health. Regulation aids economic and development objectives. Every industry must produce safe products. And with scientific innovation comes success.”
For the next six months, Africa’s NRA CEOs will be paired with faculty members as mentors. This inaugural programme will extend to other health regulatory professionals in future.
- CEOs of National Regulatory Authorities who attended are: Dr Seima Dijen (Botswana), Dr Fred Siyoi (Kenya), Dr Tania Vuyeya Sitle (Mozambique), Fransina Nambahu (Namibia), Dr Mawien Atem (South Sudan), Dr Burhani Othman (Zanzibar), Delese Mimi Darko (Ghana), Professor Mojisola Adeyeye (Nigeria), Dr Adam Fimbo (Tanzania), Dr Tumi Semete-Makokotlela (South Africa), and Richard Rukwata (Zimbabwe).
- Faculty members and mentors who attended are: Honorary Professor Muhammed Pate (Minister of Health, Nigeria), Professor Helen Rees (Wits RHI), Professor Rifat Atun (Harvard University), Precious Matsoso (HRSP, Wits), Chimwemwe Chamdimba (African Medicines Regulatory Science Platform, AU), Professor Maurice Radebe (Wits Business School), Professor Logan Rangasamy (Wits Business School), Dr Pino Mavengere (Wits Business School), Dr Karima Ladhani (Harvard), Dr Joey Gouws, former head of the NRA, South Africa), Dr Margareth Ndomondo-Sigonda ( ARLP Project Manager), Dr Hiiti Silo (WHO), Dr Emer Cooke (European Medicines Agency). Gugu Mahlangu (Former DG of the Medicines Control Authority of Zimbabwe), Apollo Muhairwe, Former CEO, Uganda, NDA, Ben Botwe, Former Deputy Director, Ghana FDA), Professor Papa Amadou Diop, Former NRA head, Senegal), Robyn Hayes Badenhorst, Wits Health Consortium and Supporting Health Initiatives (SHI).