The African Medicines Agency (AMA) will be key to the integration of African manufacturing into the global pharmaceutical value chain, an important step for improving global pandemic preparedness for the benefit of all of humanity, writes Dr Lenias Hwenda, founder and CEO of Medicines for Africa, in Daily Maverick.
She writes:
“Tell your government they should ratify the African Medicines Agency (AMA). We need South Africa on board.”
An African Union official said this to me in Kigali during a conference on African vaccine manufacturing. She mistook me for a South African. I am a Zimbabwean ….
Patrick Tippoo, the head of Science and Innovation at Biovac, one of SA’s vaccine manufacturers, had made this very point to me earlier.
His concern was that African governments were not ratifying the AMA fast enough to send a strong signal of their unwavering commitment to it and to the ambition to strengthen medicines and vaccine manufacturing in Africa.
The AMA Treaty is a legal instrument for formally establishing a regional medicines agency on this continent. It was adopted by the African Union Assembly in 2019 and formally established in November 2021.
It will be hosted by Rwanda and its purpose will be to improve oversight over the quality, safety and efficacy of medical products taken by Africans, drive investment in research and development of medical products, and enable the scale-up of vaccine production in Africa.
The AMA will be key to the integration of African manufacturing into the global pharmaceutical value chain, an important step for improving global pandemic preparedness for the benefit of all of humanity.
In September 2022, I asked Boitumelo (Tumi) Semete-Makokotlela, CEO of the South African Health Products Regulatory Authority (SAHPRA), why South Africa was holding out on ratifying the important treaty for AMA. Were there concerns about what the AMA would mean for nations among legislators of South Africa and others like Nigeria, Ghana and Kenya that were still to ratify the treaty?
Tumi said South Africa had no major concerns, but the time taken simply reflected the slow churning of its political processes.
As far back as 2017, when the initial consultation meeting on the AMA was held in Johannesburg, the country’s political leadership insisted on its support for the AMA.
Health Minister Dr Joe Phaahla echoed this sentiment in February 2022 during his joint tour with the WHO’s director-general of the WHO mRNA vaccine technology transfer hub led by Professor Petro Terblanche, MD of Afrigen Biologics and Vaccines in Cape Town.
Phaala said SA supports a continent-wide medicines regulatory authority and would soon sign the treaty. “There is no hesitation in principle. It’s more operational in terms of making sure that we do sign the Treaty on the AMA.”
The gap between the words and actions of politicians is well known, however. Without signing and ratifying the AMA Treaty, the government’s words were just that – words.
Now, the first step to closing that gap has now been taken. On 21 September, the Cabinet approved the signing of the AMA Treaty and its submission to Parliament for ratification. Once that is done, Africans can celebrate.
And why should they? Because this would be an unequivocal show of South Africa’s commitment to strengthening Africa’s medicines regulatory system so that more people on this continent can have safer medicines.
Such an act will advance South Africa’s, and in fact the whole of Africa’s, global standing as a strong hub for a well-regulated life sciences sector that can contribute to the global pharmaceutical value chain. So that’s the first reason to celebrate.
At the time of my conversation with Tumi on 19 September 2022, SAHPRA was not yet certified as a regulator meeting the WHO standards of high maturity, even though several African agencies were already certified.
This seemed a bit strange to me because SAHPRA is one of Africa’s highest performing regulatory agencies.
So, I had to ask Tumi: “Why does SAHPRA – one of Africa’s largest and strongest health products regulatory agencies – not have a WHO-certified maturity level? After all, smaller agencies with fewer resources like the Ghana FDA and the Tanzania FDA have already achieved Maturity Level 3 while South Africa has not.”
Her answer was simple: “We are already operating at Maturity Level 3. We just never took the administrative step of getting audited and certified. We will now get audited and certified. After that we want to attain Maturity Level 4.”
Two weeks later on 5 October 2022, the WHO confirmed that SAHPRA met the standards of a level 3 maturity agency. And so, SAHPRA became one of five African medicines agencies operating at a high maturity level 3.
More are on the way. SAHPRA’s CEO has bigger ambitions, however. She wants to make SAHPRA a Level 4 regulatory agency – the highest level possible in the world, which would make SAPHRA a reference agency on a par with the US FDA, Europe’s EMA and the UK’s MHRA. It is an ambition well within reach for SAHPRA.
The second reason to celebrate the decision to ratify the AMA Treaty is that South Africa is a political and economic powerhouse on the continent. Its actions or its failure to act have significant implications for the rest of Africa.
Consider for instance that this country is arguably the most important regional manufacturing hub for medicines and vaccines in Africa. Through sustained investment, it has built a thriving life sciences sector that is expanding its capabilities into new areas, which include pathogen genomic surveillance and novel manufacturing platforms, such as mRNA technology systems.
It hosts one of Africa’s most promising biotechnology companies, Afrigen Biologics and Vaccines. Afrigen is important for its leadership of the WHO’s hub for expanding mRNA vaccine manufacturing capabilities into low- and middle-income countries using mRNA-based technologies.
A South Africa whose life sciences sector is supported by a regulatory agency operating at the highest level in the world, SAHPRA, complemented by a regional institution like the AMA and four other medicines agencies operating at the high Maturity Level 3 – those of Tanzania, Ghana, Nigeria and Egypt – would be formidable.
On the AMA Treaty ratification front, things are moving at a rapid pace. Since November 2021, when the AMA Treaty came into force after ratification by the minimum 15 African nations, 34 governments, including South Africa, have come on board.
Now with a two-thirds majority of the African Union’s member states on board, there should be no further delays in ratifying a treaty for such an important institution.
We need to move. The people of Africa suffer perennially from lack of access to quality safe medicines and vaccines. Acceleration of the ratification process by the remaining “holdout” African parliaments, including those of Ghana, Nigeria and Kenya, would send an important message to Africans and to the world that this is about to change.
It would signal a very positive turn for the African pharmaceutical landscape and Africa’s plans to scale up vaccine manufacturing on the continent.
Delays are also pernicious in another way. Namely, any delays in strengthening Africa’s regulatory environment are sure to be exploited by those who stand to gain from the status quo.
Pretoria’s approval of the signing of the AMA treaty is a major milestone. Those African parliaments who have not ratified the treaty yet must now stop twiddling their thumbs and accelerate their ratification efforts as a first step on this journey of 1 000 miles ahead of us."
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