A number of parliamentarians this week supported the establishment of the African Medicine Agency (AMA), which will serve as the continental regulatory body of medicines and medical products.
Health minister Dr Kalumbi Shangula this week introduced to parliament the AMA treaty while asking parliamentarians to support the ratification aimed at assisting the African Union (AU) member states to improve their capacities to regulate medicines and medical products.
Adopted in February 2019 by the AU Assembly of Heads of State and Government, AMA will be established as a specialised agency of the AU to strengthen and harmonise efforts by the African Union Commission (AUC), Regional Economic Communities (RECs), Regional Health Organisations (RHOs) and member states, while providing them with regulatory guidance among others.
“Critically, Africa faces a major problem with substandard and falsified medical products. With porous borders, this is a continental problem that cannot be addressed by individual countries,” Shangula told MPs in the National Assembly on Tuesday. He said a 2017 World Health Organisation global prevalence estimate for substandard and falsified medical products was 10% for all products, while a 2013 systematic review reported a median prevalence of 28.5% based on 15 studies from low and middle-income countries.
Shangula said AMA would collaborate with RECs and the National Medicines Regulatory Authorities in the identification of substandard and falsified medical products and facilitate information sharing across countries.
“It is envisaged that the African Medicine Agency will provide a better environment for legitimate manufacturers to flourish and improve local manufacturing of quality products,” he added. He said the financial and technical sustainability of regional initiatives remains uncertain.
“AMA offers an opportunity to catalyse support from countries and undertake certain activities more efficiently, while at the same time consolidating the RECs initiatives,” Shangula said.
Popular Democratic Movement (PDM) shadow minister of health Winnie Moongo hailed the establishment of AMA as progressive and a step in the right direction. “It is quite a shame and embarrassment that there is mistrust even within African countries about the effectiveness and legitimateness of the coronavirus remedy that was rolled out by Madagascar recently,” she contributed. According to Moongo, this is because all African medicine has to be approved according to western standards and practices and anything contrary to that is deemed not acceptable and unsafe.
This agency, she said, would enable Africa to ensure that the continent control illicit trade of medicine within the envisioned African Continental Free Trade Agreement (AfCFTA).