Rwanda's path to pharma self-sufficiency: Strengthening regulatory oversight and building a robust healthcare system

Rwanda announced last week several appointments in key areas of the Rwanda Food and Drugs Authority (FDA) – a public agency that is charged, primarily, with regulatory affairs of the pharmaceutical sector. The appointments, approved by a cabinet meeting that was chaired by President Paul Kagame on April 3, are the latest development in a string of reinforcements that have been made in the last few years to beef up Rwanda FDA as the country looks to position itself as a regional hub for pharmaceutical manufacturing. Reymond Muganga, a PhD holder in biomedical and pharmaceutical sciences and a veteran university lecturer, was named the head of laboratory services, with the divisions of drugs and vaccines testing also getting new managers. The changes within Rwanda FDA, which is the process of securing a Maturity Level 3 (ML3) licensure, and the ongoing construction of a BioNTech vaccine plant point to Rwanda’s bold strides towards self-sufficiency in production of pharmaceuticals. ML3 certification attests, according to the World Health Organization, that a regulatory authority, like the local FDA, meets the required proficiency in key areas such as regulatory oversight, quality assurance, and compliance with international standards. Only a handful of African countries, including neighbouring Tanzania, were ML3-certified as of October 2023. Rwanda, just like much of Sub-Saharan Africa, grapples with the heavy burden of pharmaceutical imports, with up to 95% of its medical supplies sourced from outside the continent. This overreliance not only poses significant economic vulnerabilities but also undermines the country's capacity to respond swiftly to health crises and pandemics. Lessons from Covid-19 pandemic The Covid-19 pandemic served as a stark reminder of the inequities inherent in the global health system. Wealthier countries hoarded vaccines and secured doses far beyond their population needs while many African countries struggled to get their hands on even basic quantities. Rwanda, it seems, has not wasted the hard lessons from the crisis. Another important lesson, and one would hope the continent will be readier when the next pandemic strikes, is the need to have preparedness plans in place. Even when the vaccines became available, African countries faced challenges of cold chain storage and distribution networks required for effective vaccine rollout. This goes along with adequate healthcare financing and building resilient health systems. BioNTech plant in Rwanda, the first mRNA technology vaccine production facility on the continent, and the pursuit of an ML3 certification for its FDA are a critical step towards enhanced regulatory prowess and a more robust pharmaceutical ecosystem. The journey to pharmaceutical self-reliance will not be without challenges such as limited resources and skilled workforce, but, if there is anything to learn from the last 30 years, it is that Rwanda almost always figures it out. Strategic partnerships, like the one with BioNTech, are one classic example. Potential benefits By fortifying the regulatory arm of its pharmaceutical sector, Rwanda is not just striving for self-sufficiency in medicines. It will have a ripple effect on the economy and wider healthcare system. Here are a few potential benefits: Job creation: The pharmaceutical sector requires a diverse range of skilled professionals, from scientists and researchers to manufacturing technicians and marketers. This creates employment opportunities across various skill levels. Export revenue: By supplying made-in-Rwanda healthcare products to regional countries and the broader African continent, the country would cut its imports bill and, at the same time, generate revenue. This boosts foreign exchange reserves and contributes to a positive balance of trade. Disease management: Pharmaceutical companies play a critical role in developing drugs and vaccines, contributing to disease management and prevention efforts. This would particularly benefit Rwanda in times of public health crises like the recent Covid-19 pandemic. Infrastructure development: The presence of pharmaceutical firms often leads to the development of specialised healthcare infrastructure, including research facilities, manufacturing plants, and distribution networks. This enhances the overall capacity and resilience of the healthcare system. Rwanda has already been confirmed as host nation for two key continental agencies, the African Medicines Agency (AMA) and the African Pharmaceutical Technology Foundation, and this will complement the country’s goals of self-reliance in medicines and vaccines, and serving fellow Africans. After all, as President Kagame said at the inauguration of the BioNTech vaccine manufacturing site last December, the facility is “designed to be among the most advanced in the world” and that is what Rwanda and Africa deserve – the best. The writer is a pharmacist by training and a senior editor with The New Times

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Rwanda's path to pharma self-sufficiency: Strengthening regulatory oversight and building a robust healthcare system