Health minister Dr Kalumbi Shangula this week re-introduced a motion seeking the establishment of an African Medicine Agency (AMA), which will serve as the continental regulatory body of medicines and medical products.
The AMA treaty was initially introduced to the National Assembly two months ago, but debate on the issue was disrupted by the mid-year recess for parliamentarians.
The treaty would enable Africa to ensure that the continent controls the illicit trade of medicine within the envisioned African Continental Free Trade Agreement (AfCFTA).
The treaty to establish the AMA was endorsed by the AU Summit in February 2019.
The treaty requires ratification by a minimum of 15 countries before the AMA comes into force. Thus far 17 countries have signed the treaty but only two have ratified it.
AMA will collaborate with national medicines regulatory authorities in the identification of substandard and falsified medical products and facilitate information sharing across countries.
Shangula said due to porous borders, falsified medical products remain a continental problem. “In the current Covid-19 era it is the ideal body to assess the Covid-organics offered by Madagascar and make a recommendation that would assist African states to make an informed decision on this product.
It is envisaged that the AMA will provide a better environment for legitimate manufacturers to flourish and improve local manufacturing of quality products,” Shangula noted.
A 2017 WHO global prevalence estimates for substandard and falsified medical products was 10% for all products, while a 2013 systematic review reported a median prevalence of 28.5% with a range 11-48% based on 15 studies from low and middle-income countries. He said the financial and technical sustainability of regional initiatives remains uncertain, adding the AMA offers an opportunity to catalyse support from countries and undertake certain activities more efficiently, while at the same time consolidating the regional economic communities (RECs) initiatives.
Shangula cited many national medicines regulatory authorities being critically understaffed to inspect the hundreds of manufacturing facilities making medicines and vaccines and to maintain required vigilance over time. AMA is also expected to play a key role, working closely with the WHO on the evaluation of, and oversight for the use of medical countermeasures for public health emergencies.
The Africa Union executive council decision in January 2015 recognised the need to strengthen capacity of medical products regulation in Africa and the harmonisation of regulatory systems as a foundation for the establishment of a single medicines regulatory agency in Africa, within the context of the African Medicines Regulatory Harmonization (AMRH) Initiative, as part of the Pharmaceutical Manufacturing Plan for Africa (PMPA).