Professor Heather Hamill and Dr Fanqi Zeng have renewed their call for stronger regulation to combat the spread of substandard and falsified medicines, writing in Science.
With such medicines widespread across Africa, the African Medicines Agency has the potential to play a crucial role in addressing this global health challenge.
The spread of such medicines is a very real but often neglected global challenge – the World Health Organisation (WHO) suggests that as much as 10% of medicines in lower- and middle-income countries are either substandard (due to low quality) or falsified (due to fraud).
These poor-quality medications can have serious impacts on global health, increasing mortality, causing adverse impacts on health, contributing to loss of faith in healthcare, and increasing antimicrobial resistance worldwide.
The UN has estimated that over a quarter of a million people in sub-Saharan Africa die each year because of faulty antimalarial medicines. A further 169,000 deaths per year are linked to counterfeit and substandard antibiotics.
Between July and October 2023, about 70 Gambian children under the age of 5 died after drinking cough syrup containing high levels of toxins. These tragic deaths exemplify the dangers of medicines that fail to meet quality specifications and standards, as well as those that deliberately misrepresent their identity, composition, or source.
In order to regulate the quality of all medicines, coordinated leadership and extensive data collection are required.
However, limited coordination between international, national, and local regulatory bodies continues to undermine effective oversight and enforcement.
Professor Hamill and Dr Zeng argue that the African Medicines Agency (AMA), established in 2021, could play a central role in addressing this issue.
An effective AMA could coordinate surveillance, guide policy making, and integrate these countermeasures into broader health initiatives. The AMA could also facilitate a robust consensus on standards for serialisation, track and trace technology, and quality control, which could deter counterfeiters and encourage best practices.
The AMA could also incentivise and foster research partnerships and collaborations with African universities, increasing the database of substandard and falsified medicine prevalence rates.
By facilitating effective quality control and streamlining data collection, the AMA could help to protect millions of African lives from this silent epidemic.