After more than a decade of planning, the launch of the African Medicines Agency (AMA) is being celebrated in Mombasa, Kenya, this week at the Seventh Biennial Scientific Conference on Medical Products Regulation in Africa. The agency’s establishment marks a pivotal moment in Africa’s public health, at a time when the need for biomedical research conducted in Africa, focused on African health problems, has never been greater.
Africa holds higher levels of human genetic diversity than anywhere else on Earth, but this diversity has not been adequately studied. And many 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 African ancestry1,2.
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This year, cuts of billions of US dollars in international funding for biomedical research and health services in Africa have left millions of people without access to life-saving treatments or, in the case of researchers and health-care workers, unemployed. This demonstrates the immense vulnerability that comes with relying on funding from external donors.
What’s more, Africa’s phenomenal population growth and pace of urbanization is bringing fresh challenges — as well as opportunities — around health and disease. In Africa’s cities today, the inhabitants of increasingly affluent neighbourhoods are demanding high-quality medicines and health care. But in low-income areas, high population density, inadequate housing and poor sanitation are facilitating the spread of respiratory and diarrhoeal infections3. And everywhere, inadequate diets, air pollution, smoking and physical inactivity are driving increased rates of cardiovascular disease, diabetes and cancer4. By 2100, Africa is expected to host 13 of the world’s 20 largest cities5, and such inequalities are likely to worsen.
In the context of all these challenges, the AMA is more than just another regulatory body. It represents a test of whether Africa can claim its rightful place in shaping the science that will help to determine the health of its growing population.
If the AMA ensures that preclinical models for drug testing reflect African biology, that African genomes are woven into drug discovery from the start, and that clinical trials conducted on the continent are rigorous, it will improve the health of billions of people of African ancestry. By helping to generate a more complete picture of human genetic diversity and the links between genetic variation, disease and treatments, it will also redefine standards around drug development and clinical trials globally.
Drug discovery for Africa
Multiple studies spanning three decades have shown that individuals from different regions and ethnic backgrounds respond to medicines differently6. But although Africa holds around 18% of the world’s population and accounts for 25% of the global disease burden7, the continent’s genetic diversity is rarely considered in preclinical or clinical research8.
African biomedical data sets are hugely under-represented. Only 4% of the data in the Pharmacogenomics Knowledgebase (PharmGKB), a public database that provides information on the links between genes, drugs and diseases, come from individuals of African ancestry, for instance.
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