Boost to pharma production: Africa inches closer to setting up own drug regulator as member states ratify treaty

Agency will ensure drug manufacturers get approval from all African Union member states without a lengthy bureaucratic process

By Tony Malesi
Published: Wednesday 24 May 2023
Photo: iStock__

Plans to set up the African Medicines Agency (AMA), which will oversee regulatory processes for pharmaceutical products across Africa, are at an advanced stage, according to official communication.

As many as 35 of the African Union’s 55 member states have ratified the AMA Treaty, officials said.

Kenya, Malawi and Sao Tome are some of the latest countries to sign the treaty. The move will support the growth of local pharmaceutical production amid calls for a One Health approach for disease control in Africa, according to officials. 

In a statement, Chimwemwe Chamdimba, the head of health at the AU Development Agency-New Partnership for Africa's Development (AUDA-NEPAD), said the agency’s bureau has already been formed and its governing board is taking shape.

She added: 

AMA will be a specialised health agency of the AU, aiming to ensure the regulatory harmonisation of medicines across Africa. Plans are underway to ensure the governing board is formalised by member states in the next few months.

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 harmonisation 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.

AU is working with partners such as Amref Health Africa, a nonprofit, to train national regulators. It is also developing a continental regulatory reliance framework, which will be piloted in the East Africa region.

AU has also mandated AUDA-NEPAD to lead private sector engagement in health to have a more systematic way of engaging the private sector, said Chamdimba. 

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).

Unfortunately, access to medicines in Africa has always faced a myriad of challenges. Thus, the need for effective universal access to medicines, a pet topic at most conferences, can’t be deemphasised. 

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.

These lacunae have resulted in the circulation of fake and counterfeit medicines, which kill over 500,000 Africans yearly, according to the United Nations.

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, Hassan Nyawanga, a Kenyan nurse, told this reporter.

Everyone should have access to life-saving or health-promoting interventions, he said, calling the move a good idea. “Due to poor health policies and poor supply chains that force many to opt for out-of-pocket payments for medicines, the continent has a long way to go to achieve Universal Health Coverage,” said Nyawanga.

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.

“AU should move with speed and set up AMA’s governing structure, instal a director-general and operationalise the agency to help bridge the huge gap in accessing medicines and general healthcare,” said Nyawanga.

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 harmonisation of medicines in Africa,” said Sidibé, who is also a former minister of health and social affairs in Mali and former executive director of UNAIDS.

The AU Executive Council has picked Rwanda to host the AMA headquarters, AU’s commissioner for health and humanitarian affairs, Minata Samaté Cessouma, said. 

“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.

It’s 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, she added.

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 drug and vaccine production initiatives and generally strengthening health systems.

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