Africans are a step closer to speedier access to newer, safer medicines following this week’s ratification of the African Medicines Agency (AMA) treaty by 15 African Union (AU) member countries.
Although the AU adopted the treaty to set up the AMA back in February 2019, 15 African countries had to formally notify the AU Commission that they had ratified the treaty before the agency could be set up.
On Tuesday, Cameroon became the 15th country to do so, finally pushing the AMA over the threshold into reality. The AU now has 30 days – until 5 November – in which to start setting the agency up.
The AMA aims to support African countries to better regulate medical products and harmonise the regulation of medicines across the continent. It will also test samples of medicines from time to time to eliminate fakes that plague the continent.
The 14 other countries to have both ratified the AMA and “deposited the instrument of ratification” at the AU (a letter from the head of state informing it of ratification) are Algeria, Benin, Burkina Faso, Gabon, Guinea, Mali, Mauritius, Namibia, Niger, Rwanda, Seychelles, Sierra Leone and Zimbabwe.
A further three countries have ratified the treaty but not formally informed the AU, while eight more have signed the treaty but not yet ratified it.
This means 36 of Africa’s 55 countries – predominantly Francophone countries – have expressed support for the AMA.
However, African powerhouses Ethiopia, Nigeria and South Africa have not yet expressed their support for the AMA.
The COVID-19 pandemic has highlighted the need for countries to speedily assess medicines and vaccines, a capacity that a number of African countries lack.
The African Centers for Disease Control and Prevention (CDC) has played a central role in co-ordinating the health response to the pandemic on the continent, and highlighted the value of a continental player during a health crisis.
Greg Perry, Assistant Director-General of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), welcomed the AMA’s ratification, describing it as taking “one step closer to achieving a continent-wide regulatory agency”.
“We look forward to the full implementation of the AMA,, which will be a game-changer for all Africans to access safe, effective and quality medical products in a timely manner,” said Perry.
Pharmaceutical companies have long complained about how complicated it is to get medicines approved in Africa and how long it takes particularly in comparison to Europe, which processes applications via a central European Medicines Agency (EMA).
Perry added that for the agency to become fully operational, it was important for the AU to define the appropriate funding model and engage with the African Medicines Regulatory Harmonisation initiative “which has already set strong governance structures and pan-African guidance in place for the approval of COVID-19 treatments and vaccines”.
Reduce barriers to African market entry
Andy Gray, senior lecturer in pharmacology at the University of KwaZulu-Natal, said that AMA’s greatest potential lies “in the field of harmonisation of regulatory systems, which should reduce the barriers to market entry in Africa”.
“The AMA is not intended to be a supranational regulator, and will not make decisions in the way the EMA does, but it could help in bringing national medicines regulatory authorities together, simplifying systems and reducing redundancy,” explained Gray.
“It can also make a major difference by promoting transparency of regulatory action across the continent, and showing how that can drive reliance models of regulation.”
Gray added that the AMA could learn lessons from the Africa CDC by providing “visible and credible leadership”, ensuring “practical outputs, not just talk” and ensure it had recognition in appropriate global forums.
Earlier this year, Michel Sidibé, the former Executive Director of UNAIDS and Mali’s Minister of Health, was appointed as the AU’s Special Envoy for the AMA. He has been leading efforts to ensure that countries ratify the agency, and could be in the running to head it.
Announcing Cameroon’s ratification of the AMA on Twitter this week, Sidibé described the agency as a “game-changer for our continent”.
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