Strengthening Africa's health systems: Insights from NEPAD's top official on medicines regulatory programme

Africa has long grappled with the challenges of access to high-quality medical products for its over 1.4 billion population. Available data indicates that the continent imports over 90% of its health commodities. The crisis of substandard and falsified medicines also exacerbates the situation, undermining trust in healthcare systems and leading to severe health outcomes. The Covid-19 pandemic laid bare the vulnerabilities, revealing the urgent need for robust, locally coordinated regulatory frameworks and manufacturing capabilities. The African Medicines Regulatory Harmonisation (AMRH) programme was established, in 2009, with the vision of addressing these critical issues by harmonizing regulatory standards across the continent. Over the past 15 years, the programme has made some great strides, including the adoption and ratification of the African Medicines Agency (AMA) treaty by 29 member states as of June 2024. The agency is tasked to improve the availability, safety, and efficacy of medical products and help build a resilient health infrastructure that can withstand future health shocks. Rwanda was the first country to ratify the treaty, and has been confirmed as the host country of the agency’s headquarters. Chimwemwe Chamdimba, the head of AMRH programme at the African Union Development Agency (AUDA-NEPAD), spoke exclusively to The New Times’ editor Richard Bishumba. Her insights shed light on progress, challenges, and the future of AMRH programme, as well as the critical role of collective responsibility in improving public health in Africa. What does the AMRH programme mean for the ordinary African citizen? Our work is fundamentally about ensuring that public health systems across Africa have access to quality-assured medical products. When we talk about medical products, we mean those that are safe and effective, and that can treat and diagnose as intended. For the average citizen, this translates to trust in public health facilities. If people can find reliable medical products when they need them, they retain trust in the health system. Our goal is to support governments in providing these essential products, thus addressing diseases, outbreaks, and other health challenges more effectively. Can you elaborate on the issue of substandard and falsified medical products in Africa? Substandard and falsified medical products are a significant problem on our continent, leading to severe consequences, including loss of lives. No one should suffer or lose a loved one due to ineffective or dangerous medications. The AMRH initiative, through the establishment of the African Medicines Agency (AMA), aims to uphold the right to health and life for Africans by ensuring access to high-quality medical products. This involves various interventions to combat substandard and falsified products, thus safeguarding the health of our population. How do you assess the progress of the AMRH programme over the past 15 years? Progress has been commendable, although there is always room for improvement. For instance, comparing our journey to that of the European Medicines Agency, which took a long time to establish, we have made significant strides in a relatively short period. In 15 years, we have supported regions in harmonizing standards and guidelines, building trust, and adopting best practices. One notable achievement is the ratification of the AMA treaty by 29 member states since 2019, making it the second fastest treaty to come into force in the African Union (AU) system. There are treaties that have been sitting on the AU shelves for years, with only a few member states having ratified them. However, if you look at the AMA treaty, 29 member states have ratified it already and we are seeing actually more and more countries, honestly, getting on board. What can be done to improve the pace and effectiveness of the AMRH programme? While we have made significant progress, the urgency of our health challenges demands that we accelerate our efforts. We need to work faster and more efficiently, particularly in areas like local manufacturing and regulatory system improvements. Because of the gravity of our problems, we must move even faster than we are currently moving. For instance, if we are talking about local manufacturing and ensuring the quality of products, we need to improve our regulatory systems. And this is also a call to member states because as the AU, we can only do so much. This requires stronger collaboration among all member states to ensure comprehensive and harmonized regulatory systems. The involvement and commitment of all 55 member states are crucial for the success of our initiatives. Will the benefits of the African Medicines Agency (AMA) extend to non-member states? By nature, AMA is a treaty-based institution primarily serving its member states. However, given its public health mandate, there could be mechanisms to support non-member states. The goal is to encourage all AU member states to ratify the treaty and participate fully, ensuring that the entire continent benefits from AMA's initiatives. We will find ways that AMA can reach out to the others while we work with them and encourage them to ratify the treaty. But, of course, that cannot be forever because, admittedly, it is the state parties that are going to be making direct contributions as per the treaty. So we need all the member states to shoulder the burden of, you know, financing the African Medicines Agency. What message would you like to leave stakeholders of the AMRH programme? Everyone has a role in advancing Africa's health landscape. Whether through private sector, media, legislative reforms, regulatory work, or civil society efforts, we must all champion the cause of ensuring access to quality medical products. It is essential to create a network of stakeholders dedicated to this continental mission, leveraging our respective roles to achieve our common goals.

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Strengthening Africa's health systems: Insights from NEPAD's top official on medicines regulatory programme