Why the African Medicines Agency’s Hour Has Arrived

With SARS-CoV-2 infections on the rise, health systems across Africa are facing increasing pressure. Though researchers are working around the clock to unlock the science to help treat the disease, regulators must play a key role in ensuring the rapid – yet safe - development of treatments and vaccines. But Africa faces a significant stumbling block in its ability to address the pandemic: varying regulatory systems across the continent make it difficult to mount appropriate responses. Efforts for regulatory harmonization have been underway for the past decade, and this work has never been more important. Parliaments are now calling for approval to establish the African Medicines Agency (AMA) (1) – a proposed regulatory authority that would oversee the harmonization and convergence of medical and pharmaceutical regulation for African Union (AU) member states. Recently, Margaret Agama-Anyetei, Head of Health, Nutrition, and Population at the African Union Commission, urged the AU to ratify the treaty for the formation of the AMA before its next assembly in February 2021. The benefit, she explained, was that “instead of talking to eight regional economic communities or 55 countries, there would be one organization speaking on behalf of the continent (2).” 

The AMA is expected to be essential in enabling patients to access safe, effective, high-quality, and affordable drugs, treatments, and vaccines. The main purpose of the agency will be to coordinate ongoing regulatory systems, provide guidance, and to foster reliance and regulatory harmonization across the continent. These are crucial to responding to public health threats, such as COVID-19. They will also help thwart the dangerously large and thriving market for falsified medicines. The unregulated sale of fake drugs is responsible for tens of thousands of premature and unnecessary deaths among African patients who unwittingly fall prey to counterfeiters. The WHO stated that the continent accounted for 42 percent of all counterfeit drug reports between 2013 and 2017 (3).

With the need to manage such significant issues, most people are in agreement that a continent-wide body will coordinate the work already being done by national regulatory authorities (NRAs) and allow the pharmaceutical industry to make good on its promise to leave no-one behind. But with the disruption caused by the pandemic, how near are African governments to realizing their goal?

Initiatives now

The pandemic has slowed down the process of ratifying the AMA in some countries because it has become the sole major issue confronting and preoccupying national authorities. However, “We are making good progress," said Margareth Ndomondo-Sigonda, AUDA-NEPAD's Head of Health Programmes. She explained that the results already achieved by the African Medicines Regulation Harmonization initiative (AMRH) have proven “key in building robust regulatory systems in Africa, including the establishment of the AMA (4).”

Africa’s national regulatory authorities (NRAs) have already faced many challenges that come with infectious diseases – the HIV-AIDs crisis, Ebola and malaria have all tested capabilities. However, with COVID-19, NRAs can now benefit from virtual working methods that the pandemic has, in a matter of months, made the new norm for many. Using modern digital infrastructure, we hope to accelerate the implementation of good and efficient regulatory policies and practices and make the AMA one of the most efficient and modern regulatory systems in the world.

Africa still has some ground to cover in closing the regulatory gap. With this being said, the AMA should be empowered to foster unprecedented coordination, partnership, and sharing that we’ve all witnessed during this pandemic, and enjoy the benefits of shared regulatory experience. There is scope for expanding the current expedited processes to facilitate regulatory applications for new drugs, variations, and clinical trials used for COVID-19 treatments and vaccines – without, of course, cutting any corners. We're talking about priority and fast-track reviews, as well as temporary authorizations.

Similarly, the pandemic has underlined the vital need to ensure the continuous supply of existing medicines that patients urgently require. There are a range of ways that regulators like AMA can facilitate the process, including expediting procurement, helping with the security of the supply chain, and fighting falsified medicines. 

Elsewhere, the pandemic has, fortunately, prompted a growing awareness of the need for coordinated regulation; 17 countries out of the 55 have now signed the AMA treaty, demonstrating that they see the agency's work as vital. Ghana and the Seychelles ratified the AMA last month; just after three other countries – Burkina Faso, Mali, and Rwanda – did the same.

Today, there are various coordinated national efforts to combat and mitigate the effects of COVID-19 led by the Africa Centres for Disease Control and Prevention (Africa CDC) Africa Task Force for Novel Coronavirus (AFCOR) and WHO Afro, in collaboration in particular with the African Vaccine Regulatory Forum (AVAREF) and the Africa Medical Devices Forum (AMDF). In addition, the AU launched a new multi-stakeholder initiative via the Africa CDC: The Consortium for COVID-19 Vaccine Clinical Trial (CONVACT). It aims to get more than 10 late-stage vaccine clinical trials up and running as early as possible on the continent by bringing together global vaccine developers and funders, as well as African organizations that can facilitate clinical trials.

So far, so...

Though the AMA is not yet a reality, other pharmaceutical bodies are working to address current health threats. AVAREF and other stakeholders have been successfully working together, often sharing data and collaborating on new initiatives – examples of this are the clinical trial authorizations (CTAs) for hydroxychloroquine and ritonavir involving 14 countries in an unprecedented joint review. If expedited, CTA could be delivered in just over 30 days and, in an emergency, 10-15 days compared with the conventional 6-12 months if national regulators go it alone. But this approach is just one piece in the complex jigsaw to remove potential inefficiencies and delays resulting from repeated steps and duplication of work. 

Thankfully, progress in information sharing and implementation is being made. Our industry’s commitment to “define the best science-based regulatory strategies for ensuring the availability of COVID-19 medicines and vaccines” is being realized and whether or not the AMA is approved before the AU Assembly meets again, pharma is dedicated to supporting those most in need. Leaning on decades of innovation and experience, the international community will be able to contain and find real solutions to the COVID-19 pandemic together.