Ratification of Africa Medicines Agency Treaty Inches Forward – Africa CDC Head Calls It ‘Much-Needed’ 
John Nkengasong, Director of the Africa Centres for Disease Control and Prevention (Africa CDC) at Thursday’s press briefing.

IBADAN, Nigeria – Nearly two years after the Assembly of the African Union, adopted a milestone  treaty establishing an African Medicines Agency (AMA) that could provide a more unified approach to regulatory approval of new medicines and vaccines, the AMA treaty is yet to enter into force – because it has not been ratified by 15 countries.  

So far only 18 of Africa’s 55 countries have even signed the framework agreement establishing the agency, including the Republic of Congo, which signed in Addis Ababa just yesterday.  But only 5 countries have actually ratified the agreement – including Rwanda, Mali, Burkina Faso, Ghana and Seychelles. Major holdouts include almost all of the largest countries in southern and eastern Africa, along with Nigeria, the Democratic Republic of Congo, and Egypt.

18 of Africa’s 55 countries have signed the AMA agreement, while only 5 have ratified it

Paradoxically, a functional AMA could also be a valuable tool in the fight against the COVID-19 pandemic that has already claimed thousands of lives across the continent – speeding new drugs and a hoped-for vaccine more quickly to markets, said .  

Fielding questions Thursday from Health Policy Watch, Director of the Africa Centres for Disease Control and Prevention (African CDC), John Nkengasong,  a Cameroonian virologist, attributed the delay in treaty ratification to the political processes that the agreement must move through in individual AU member countries – which have stalled due to the pandemic.

“There is a lot of work to be done to bring other countries on board. It has to go through the parliament of each country. There is a process,” Nkengasong told Health Policy Watch.  He said that he regretted that the approvals have not moved faster. 

“I don’t think it is because countries do not want to sign on. I think it is because of the process that is required to make them sign that treaty, and the countries are currently focusing more on COVID-19,” Nkengasong said, adding: “I think it’s a much needed institution. If we had the AMA, it would be working very closely with the WHO and other bodies to facilitate regulatory issues on drugs to help control the COVID-19 pandemic.”

Shabir Madhi, Principal Investigator of the first Covid-19 vaccine trial in South Africa

AMA Approved in February 2019 

Establishment of the AMA was approved in principal at the thirty-second ordinary session of the Assembly of the African Union (AU) in February 2019. 

Drafted before the onset of SARS-CoV-2, proponents of the agency perceived a need for a more unified approach to drug reviews and approvals, based on experience with recent disease outbreaks, such as the devastating Ebola epidemics in western Africa and the Democratic Republic of Congo, which led to shortfalls in many needed health products. Although the emergencies triggered new R&D into vaccines and other medical products – getting new products into clinical trial, through approvals, and to market remains a complex process with different regulatory and oversight mechanisms operating in every country affected.  

Most of the countries that have signed onto the agreement so far are located in north and west Africa. They include Algeria, Benin, Burkina-Faso, Chad, Gabon, Mali, Senegal and Tunisia, among others. Even so, Cameroon, Nigeria and the Democratic Republic of Congo, in western and central regions, as well as leading southern and eastern Africa nations, such as South Africa, Kenya, Uganda and Tanzania, are yet to even approve the agreement. Likewise, Egypt remains a holdout.   

When it becomes operational, AMA is expected to link up existing national regulatory systems with the continent-wide approval mechanism, to speed up review and approval processes, improving access to essential medicines.  

With the race for COVID-19 vaccines heating up, and with palpable nationalist tendencies already emerging, Nkengasong said the AMA would now be well placed to champion the cause of COVID-19 vaccines and drugs for African countries – and ensure a more rapid, but also well-managed, introduction to markets. 

“If we had the AMA, it would be working very closely with the WHO and other bodies to facilitate regulatory issues on drugs to help control the COVID-19 pandemic. I think it’s a much needed institution.”

WHO Also Waiting in Wings for AMA Ratification 

Following the AU’;s lead, The World Health Organisation (WHO) signed a memorandum of understanding with the AU in November 2019 to collaborate on improving access to medicines, strengthening epidemic preparedness, and expanding universal health coverage across the African continent.

Under the agreement, WHO will provide technical expertise to the AMA, bolstering it to support regulatory approvals and local production of essential medicines, while hopefully increasing access to quality-assured drugs.

“One of the biggest obstacles to improving access to medical products in Africa is the lack of strong national regulatory systems. To address that, all of the African Union countries signed a treaty at the AU Summit last year to create an African Medicines Agency,” said Dr Tedros in January 2020, at moment when excitement for the idea was high, before the COVID-19 swept across the world. Speaking at Thursday’s press briefing, WHO Regional Director in Africa, Dr Matshidiso Moeti, reiterated that in spite of the delays seen since, the global health body is still fully supporting AMA and would like to see it come to reality.

Matshidiso Moeti, Regional Director of WHO Regional Office for Africa

“AMA is a very important platform for medicines to be available and affordable equitably, and to be of good quality so that we have both good outcomes for the money that people and countries are spending, and that we prevent problems,” Moeti told Health Policy Watch.

Intra-African Nationalist Tendencies – Another Factor?

Healthcare workers don protective equipment during Ebola outbreak which wracked DRC in 2018-19

Delays in ratifying intra-African treaties is not unique to the AMA. In fact, it has become a familiar dynamic, with the most recent issues arising around the African Continental Free Trade Area (AfCFTA) which is aimed at accelerating intra-African trade and boosting Africa’s trading position in the global market by strengthening Africa’s common voice and policy space in global trade negotiations.

Despite its purported benefits, Nigeria which is the continent’s most populous country and the largest economy, held out for some time.  It was among the last countries to sign to be part of the AfCFTA agreement in July 2019. Nigerian President Muhammadu Buhari explained this saying that the country wanted to avoid undermining local manufacturers and entrepreneurs.

With the ratification of the AMA treaty dragging behind despite its exigent need in the middle of a pandemic, concerns are emerging that Nigeria and other African countries with large pharmaceutical markets may be holding out in a similar fashion to safeguard and protect their local markets over continent priorities.

While fighting fake drugs and improving the quality of pharmaceutical products are shared goals of most countries in Africa, there are also fears that a more centralized approach to regulatory approvals may not sufficiently different countries’ distinctive national features and needs, some experts say. For instance, while some countries already have well-controlled drug sectors, others are still struggling. This and other issues could tend to push ratification of a continent-wide treaty lower on the agenda in some countries, as local health authorities are focused on very immediate vaccine and medicines supply chain needs, as well as lowering the impacts of COVID-19. 

Even so, there are still hopes that the treaty will be ratify during the next general assembly meeting of the African Union in February 2021, as per the comments of  Dr. Margaret Agama-Anyetei, head of health, nutrition, and population at the African Union Commission, in a July 2020 interview with Devex.  

In terms of Africa CDC, Nkengasong said the AMA, once it is ratified, will become a critical component towards achieving the AU’s Agenda 2063 — a call for action to all segments of African society to work together to build a prosperous and united Africa based on shared values and a common destiny.

“We have a serious issue of drugs that are counterfeit on the continent and that creates a huge economic loss for the population; it has a huge effect on the ability to create antimicrobial resistance (resistance to antibiotics). With the creation and ratification of such an agency, those issues we believe will begin to be addressed,” Nkengasong told Health Policy Watch

Image Credits: Africa CDC, Health Policy Watch – based on data from nepad.org, University of the Witwatersrand, WHO, Twitter: @WHOAFRO.

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