15 December 2023

By Lenias Hwenda

We may not know who these pioneering women are, but the institution they set out to create has been doing business for more than a decade and has been supporting oversight over manufacturing operations across the continent amongst other things. When I asked Mrs Chimwemwe Chamdimba, the Malawian national who is currently leading the African Medicines Regulatory Harmonisation (AMRH) Initiative, when the African Medicines Agency (AMA) will begin its work, she replied:

“The African Medicines Agency has been up and running since 2009 when we started the African Medicines Regulatory Harmonisation Initiative.”

The agency already exists as an AU initiative in the form of the AMRH Initiative — an initiative of the African Union (AU) Development Agency, Auda-Nepad under the oversight of Chamdimba. Once the legal processes necessary for establishing the institution are completed, the AMRH Initiative will become the AMA, and will operate alongside other AU Agencies like the Africa Centre for Disease Control. The AMA is expected to open its doors soon.

Thanks to President Paul Kagame and the government of Rwanda, the agency’s offices are ready, waiting for staff to occupy them and begin business in Kigali. What is left is to hire the agency’s Director General and its staff. The board of directors is almost complete, with one vacancy remaining to be filled by the end of 2023. The board’s first order of business will be to recruit a Director General.

Power of collaboration

Since 2009, the AMRH Initiative has been doing the work the AMA as a legal entity will take forward. The AMRH Initiative has been setting up systems and processes of how the African Medicines Agency will perform its business functions. Regulators across the continent have been performing and refining collaborative methods of working through the regional economic groups such as the Southern African Development Community (SADC), the East African Community (EAC) and the Economic Community of West Africa States (Ecowas) and others, collaborating on the registration of medical products for aggregate regional markets and doing joint inspections of medicines manufacturing facilities. They are now stress-testing those systems and processes to see how robust they are relative to the expectations. All that work will continue under the AMA.

The collaborative approach to regulating medical products was conceived in recognition of the different levels of regulatory maturity amongst medicines agencies across the continent. In working together, agencies of high and lower maturity (capability) exchange knowledge, helping them to improve overall effectiveness. Supporting one another has allowed African medicines agencies to grow and improve.

The Director General of the Egyptian Drug Regulatory Authority (EDA), Dr Tamer Essam, puts it this way:

“We need to exchange knowledge and create the human resources we need to strengthen the African regulatory environment… We should be collaborating on making our approaches more mature. We can use the bridge of knowledge exchange and south-south cooperation to achieve that.”

Push for regulatory maturity

Countries can also use reliance where an agency with lower regulatory capacity relies on the regulatory decisions of a higher maturity regulatory agency to reduce duplication, cost and backlogs. A core principle is that reliance should not exclusively reference stringent regulatory authorities like the European Medicines Agency or the US Food and Drug Administration. It should also include high-maturity agencies on the African continent like Ghana FDA, NAFDAC and Sahpra. 

According to Dr Boitumelo Semete-Makokotlela, who chairs the AMRH Steering Committee, “Reliance is important but the question is how do we begin to rely on ourselves so that the excellent capacity on the continent is fully utilised? Many of us struggle with backlog. Reliance and digitisation is going to help us ensure timely access to safe and quality-assured medical products on the continent.”

Countries across Africa are working hard to raise their regulatory maturity regardless of whether their government has already ratified the AMA treaty or not. They know what is at stake — that the cost of inaction is much too high for African people. Dr Semete-Makokotlela states that:

“We face an existential challenge for the well-being of our people.”

Half a million African lives are lost each year to substandard falsified medical products that take advantage of weaknesses in the regulatory environment of African markets. In 2022, we lost more than 70 children in Gambia because of severe regulatory lapses by a manufacturer and the national regulator of medicines in Gambia which led to children taking syrups contaminated with diethylene glycol (DEG) and ethylene glycol (EG). DEG contamination has been happening for the last 90 years. The tools to detect, prevent it and protect people exist. We have simply not managed to deploy them to maximum effect in Africa.

Read more in Daily Maverick: How well did SA’s medicines regulator Sahpra perform in 2022?

Therefore, we continue to struggle with the influx of counterfeit, substandard medical products which endanger the well-being of Africans. The African continent is the worst affected by substandard falsified medical products — a mammoth industry worth up to two hundred billion dollars. The total annual economic impact due to additional treatment seeking and further care after taking substandard falsified medications is estimated between $12.1-million and $44.7-million. Regulatory agencies are underfunded, resulting in inadequate regulatory oversight and there is no continental plan or strategy to fight substandard falsified medical products. The African Medicines Agency is our best hope.

Gambia had 92 suspected acute kidney injury (AKI) cases in children and more than 70 deaths. Cameroon has also been reporting child deaths due to AKI linked to an imported product. In total, 12 deaths of children have been recorded. Most go unreported. The AMRH is already creating a rapid response mechanism to tackle the enablers of substandard falsified medical products like corruption, online sales and disruption of criminal networks and enhancing criminal justice capacity. It is also working to strengthen legal frameworks alongside organisations like Medicines for Africa and others that are raising awareness and developing capacity to detect, prevent and protect patients.

Is it a realistic goal to expect Africa’s 54 countries to raise their maturity level? Indeed. The AMA requires capacity at the national level to be able to provide capacity at the continental level. And so improving capacity at national level is a necessity.

According to Chimwemwe, “The goal is not to have all countries operating at high-level maturity across the continent. What we want is for African countries to have the basic capacity to regulate medical products within their economies”.

Besides protecting the lives and well-being of Africans, improving the regulatory systems and standards is key to unlocking continental trade and investment in pharmaceuticals.

According to Dr Essam, “Local producers need a market and our African market is huge. But this market needs to be well regulated. We want Africa for Africans and Africans for Africa.”

Dr Essam does not mean that the support of partners is not welcome, but with African lives at stake, Africans must lead the efforts to do what they know must be done. To set it up for success, how the AMA should conduct its business should not be dictated from outside. In other words:

“Africa should not be a passive recipient but an active participant in ensuring that medicines of are of good quality. Only we can make the African Medicines Agency successful,” says Dr Semete-Makokotlela. DM

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