A decade in the making, the African Medicines Agency (AMA) – a new regulatory agency intended to cover the entire continent – saw its official launch at the Scientific Conference on Medical Product Regulation in Africa in Mombasa, Kenya, on 11 November.
The new agency aims to centralise and harmonise the ways medicines are developed, tested and distributed across Africa. A single coordinated approval pathway that is recognised across all member states of the African Union should drastically improve access to medicines throughout the continent, and reduce the costs and complexity of meeting individual states’ differing regulatory requirements that have previously discouraged pharma companies. As it stands, some decisions follow foreign proxies in Europe or the US, or the World Health Organization, while others must be taken country-by-country.
The AMA will also look to unify national approaches to combating distribution of counterfeit and substandard medicines, while building capacity for testing, monitoring and enforcing quality standards.
In the longer term, the agency will be pivotal in building infrastructure and expertise around developing and testing medicines within African nations. There is more genetic diversity within African populations than the rest of the world combined, but most drugs are tested outside of Africa. Enabling participation in clinical trials – and requiring relevant trials or at least in vitro testing to gain approval – should help improve treatments. It could also avoid situations where globally approved treatments and vaccines for diseases such as HIV–Aids, malaria and tuberculosis are less effective, and can even be harmful, in some people of recent African descent.
But the AMA still faces huge challenges. So far, 39 of the 55 African Union member states have signed and/or ratified its formation treaty, but they do not yet include South Africa or Nigeria – the continent’s two biggest economies – as they have so far decided to maintain their own, more established, regulatory systems. Even if they can’t be persuaded to fully participate, AMA leaders at least hope these countries will recognise and align with the emerging AMA frameworks.
The agency is also deeply reliant on funding and support from foreign partners – the European Commission and European Medicines Agency, alongside the Gates Foundation and the Wellcome Trust, have so far provided significant support, but the agency will eventually need to support itself from its members’ contributions.
As a trio of articles in Nature News outlines, the AMA is the most important development for health and science in Africa in years. It has the potential to transform the continent’s approach to healthcare, and its failure should not be an option.
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