RWANDA — The African Medicines Agency (AMA), the regulatory body of the African Union (AU) responsible for overseeing pharmaceutical processes across the continent, has made significant progress in its establishment.
Recently, Kenya, Malawi, and Sao Tome ratified the AMA treaty, increasing the total number of AU member countries under the treaty to 35 out of 55.
To support this endeavor, the AU is collaborating with partners like AMREF Health Africa, a non-profit organization, to provide training for national regulators.
AU has also mandated the AU Development Agency-New Partnership for Africa’s Development (AUDA-NEPAD) to lead private-sector engagement in health to have a more systematic way of engaging the private sector.
In a statement, Chimwemwe Chamdimba, the head of health at AUDA-NEPAD, said the agency’s bureau has already been formed and its governing board is taking shape.
Chamdimba added that AMA will be a specialized health agency of the AU, aiming to ensure the regulatory harmonization of medicines across Africa.
Once the agency is in operation, medicine manufacturers will no longer be subjected to the cumbersome bureaucratic process of seeking approval from each of the fragmented 55 member states’ regulatory authorities or the five regional economic communities (REC).
“Besides tackling fragmentation, the harmonization efforts will ensure the five African regions work together. National regulators will be able to do joint assessments and inspections. This will foster trust between the regulator authorities within the RECs,” she added.
The AU’s special envoy for AMA, Michel Sidibé, lauded the move saying the agency will encourage the development and manufacture of medicines within the continent, potentially reducing the reliance on imports from outside Africa.
“The COVID-19 pandemic exposed Africa’s vulnerabilities in ensuring access to vital drugs and commodities and AMA will improve the regulatory harmonization of medicines in Africa,” said Sidibé.
AU’s commissioner for health and humanitarian affairs, Minata Samaté Cessouma, said that it is indeed time for pharmaceutical regulatory processes and manufacturing expectations to be streamlined to prevent duplication of efforts and delays in access to life-saving medicines and vaccines.
“The response to COVID-19 pandemic diverted the already scarce health resources in Africa and threatened some of our success. However, the pandemic taught us that combined efforts can go a long way,” she said.
Africa Pharmaceutical crisis, AMA could be the answer
The lacunae of the circulation of fake and counterfeit medicines, kills over 500,000 Africans yearly, according to the United Nations Office on Drugs and Crime.
Access to safe, affordable, effective, and quality medicines is an essential component of the right to health and one of the targets in the global development agenda, according to the World Health Organization (WHO).
Besides the high disease burden, limited pharmaceutical industries, high costs of raw materials, low investment in research and development, and overdependence on countries abroad for medicines are some of the challenges Africa faces in helping the sick access medicines.
Other hurdles include poor supply chains, lack of government investment in the pharmaceutical sector, limited health workforce, lack of sustainable health financing mechanisms as well as lack of infrastructure and technical know-how.
Stakeholders in the health sector, including experts and academics, have welcomed the initiative, describing it as a game-changer in ensuring Africans have access to safe and effective medicines.
Access to affordable and safe medicines is a fundamental human right whose relevance has been given further weight by its inclusion in the UN-mandated Sustainable Development Goals target.
Considering a big chunk of the African population resides in what can be described as “rural or semi-urban areas”, the efficiency of drug supply is hampered by geographical barriers and others, such as a shortage of qualified medical personnel.
When fully operational, the AMA will complement the Africa Centres for Disease Control and Prevention, especially in pandemic preparedness.
It will also strengthen the continent’s preparedness for future pandemics and post-pandemic recovery, according to AU.
Health experts believe AMA, Africa’s second-largest health agency after Africa CDC, will be critical in nurturing the continent’s planned to drug and vaccine production initiatives and generally strengthening health systems.
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