South Africa’s Cabinet Approves African Medicines Agency Treaty

In a major step forward for the new regulatory alliance, Africa’s third largest economy, South Africa is now moving to join the African Medicines Agency – with the cabinet’s green light to join the continent-wide regulatory authority that is supposed to expedite approval of new medicines, fight fakes and over time, improve access and reduce prices. Even so, the measure still faces a parliamentary vote for ratification. 

South Africa’s cabinet on Tuesday approved the signing of the African Union treaty establishing the African Medicines Agency (AMA), a terse government statement reported Tuesday

The cabinet approved the signing of the AMA Treaty and its submission to Parliament for ratification at a virtual meeting on 21 September, the statement said. 

“Cabinet approved the signing of the Treaty for the Establishment of the AMA and its submission to Parliament for ratification,” the terse statement reported. “ This will give effect to the treaty that was adopted by the African Union Assembly in 2019. The treaty formally establishes the AMA for the continent. The agency will regulate medical products, and improve the safety and efficacy of the medical products for the continent.

“The signing and ratifying of this treaty will advance South Africa’s global and continental commitment toward strengthening the continental regulatory system on its health products,” the statement added.. 

It noted that signing and ratifying the treaty “will advance South Africa’s global and continental commitment toward strengthening the continental regulatory system on its health products”.

If the treaty is in fact signed and ratified, that would make South Africa the 34th country to swing behind the AMA – since the treaty took force in November 2021 with the ratification of the first 15 African countries to get behind the initiative. 

Describing the development as ‘great news’, Zimbabwean public health specialist who is of South African heritage, Dr Nokuthula Kitikiti, noted that South Africa has one of the few National Regulatory Agencies in Africa that have achieved the milestone of being designated as maturity level 3 (ML3) by WHO after thorough evaluation. 

“Smaller and less developed agencies can benefit from their participation in the AMA by building capacity through joint reviews and understanding the process at the South African Health Products Regulatory Authority (SAHPRA) and other ML3 agencies,” she told Health Policy Watch.

As a key regional manufacturing hub for vaccines that is also developing further capacity in novel platforms such as mRNA, Kitikiti said it was vital for South Africa to be involved in AMA as Africa builds its vaccine manufacturing capabilities. 

“South Africa also has a vibrant patient and civil society community that I am sure will enrich the continent-wide discussions on how to involve the public and patients in a more meaningful way in health products regulations as the AMA takes shape. We are still very nascent in this compared to other regions. After all, we are all doing this to make medicines safer and more accessible for patients,” she added.

Key country in operationalizing AMA 

South Africa, southern Africa’s political and economic powerhouse, has been one of the late holdouts on treaty ratification – along with Nigeria and Ghana in West Africa and Kenya in East Africa. 

This despite pledges from South Africa’s political leadership that it supported the AMA – dating back as far as 2017 when the AMA’s first stakeholder consultative meeting was held at the South African historical city of Johannesburg.

Senior South African government officials have repeatedly stated that they had no hesitation regarding being a part of the AMA. In February 2022, South Africa’s Health Minister, Dr Joe Phaahla affirmed the country’s support for the continental-wide medicines regulatory authority, and said the government would sign the treaty. . 

“There is no, in principle, hesitation. It’s more operational in terms of making sure that we do sign the Treaty on the AMA,” the minister said, during a tour by WHO’s Director General of Cape Town’s new mRNA vaccine R&D hub.

Treaty ratification remains critical next step for South Africa – also for Kenya  

Even so, ratification of the AMA treaty by the South African parliament remains a critical step before the deal is sealed. Following that, the treaty ratification then needs to be formally deposited with the African Union. 

Kenya’s parliament has remained stalled on the treaty ratification already for the past five months – ever since the cabinet signaled its approval of the treaty in May

In Kenya, the National Assembly officially received a memorandum proposing ratification of the AMA in June 2022 but nearly four months later, parliamentarians are yet to vote on the treaty. 

According to the memorandum that presented the treaty to the parliament, the signing and ratification of the treaty by Kenya will “demonstrate Kenya’s commitment to the continent’s collective action to the improved regulation of medicines, medical products and technologies… Ratification will bring about positive consequences both to the country and States Members.”

Over the summer, however, Kenya then became engaged in a bitter battle over national elections, which took place in August, leading to a Supreme Court challenge to the election of President William Ruto – whose election was ultimately upheld. The ensuing political uproar, however, likely also  delayed the parliamentary move. 

East African countries urged to sign the treaty 

The treaty has long been a topic of discussion in regional African political fora – including at events such as the Commonwealth Speakers and Presiding Officers’ Conference held November 2021 in Rwanda and attended by both Kenya and South Africa. 

South Africa approves AMA Treaty.

At the conference, the leader of South Africa’s delegation Amos Masondo, urged parliaments across the continent to “accelerate the ratification” of the treaty.

“Establishment of an AMA [will] help regulate products; help invest more in research and development, [and help countries] to build their own vaccine production while fighting to address vaccine nationalism that disadvantages the African continent,” Masondo said.

Nigeria another holdout – could be a costly delay  

In West Africa, meanwhile, Nigerian global health equity advocate, Ifeanyi Nsofor told Health Policy Watch the continual delay in the treaty’s ratification and full implementation could create confusion in the pharmaceutical landscape on the continent as countries that have already signed and submitted the treaty may have a different policy direction from those that haven’t. 

He added that the delay could also have impacts on plans to scale up vaccine manufacturing on the continent.

“Of importance is the way it could delay plans to manufacture vaccines in Africa. Infectious diseases do not care about politics. Ultimately, Africans would suffer from this reluctance. It’s a matter of life and death,” Nsofor told Health Policy Watch.

Lesotho and Mozambique the latest formal AMA entries

In spite of holdouts, the number of countries in Africa that have swung behind the treaty has continued to grow – and now constitutes a two-third’s majority of the African Union’s member states. . 

On 1 September, the Kingdom of Lesotho became the latest Member State to ratify and deposit the AMA Treaty instrument.

Congratulations to the Kingdom of #Lesotho for becoming the 23rd Member State to deposit the instrument for the Treaty establishing the African Medicines Agency #AMA this morning @_AfricanUnion
#RegulationsForASaferAfrica @AmbSamate @MichelSidibe pic.twitter.com/WY57D2HH3x

— Dorothy Njagi (@Dottienjagi) September 12, 2022

Prior to that, the Republic of Mozambique also signed the treaty on 8 August – but it has yet to ratify the treaty and deposit the ratified instrument with the African Union – as per the formal required procedure. 

Regarding the holdouts, the official AU line continues to be “countries have different ratification processes at the national level … However, the AU Commission continues with advocacy efforts to encourage more member states to ratify the Treaty.”

The Republic of #Mozambique this week became the 30th @_AfricanUnion Member State to sign the Treaty for the establishment of the African Medicines Agency #AMA. We celebrate this milestone. Congratulations to Mozambique @MichelSidibe#RegulationsforAsaferAfrica
Infographic 👇 pic.twitter.com/T08wJPY6Jr

— Dorothy Njagi (@Dottienjagi) August 5, 2022

At the same time, AU Special Envoy to the AMA, Michel Sidibé, and the AMA Treaty Alliance (AMATA) are also engaging patient groups, industry, academia and civil society to support the AMA treaty and its operationalization. 

Sidibé, who also is a former Under-Secretary-General of the United Nations, and Executive Director of the Joint United Nations Programme on HIV/AIDS (UNAIDS), described the success of this approach as reliant on “partnerships with stakeholders across the health ecosystem”.

Health Policy Watch recently highlighted the importance of African countries including South Africa, Nigeria, Kenya, Ethiopia and the Democratic Republic of Congo, ratifying the treaty, for the set goals of the agency to be achieved.

“It is very important to not lose momentum…We don’t have another way to do it except making sure that we maintain and sustain our advocacy — and we mobilize political leaders,” said Sidibé in one recent Health Policy Watch interview. 

AMA will be enlisted in African Union’s battle against drug resistant microbes 

AMA advocates have continuously underlined the knock-on benefits the new regulatory agency would have in terms of not only harmonizing the approval of new medicines – but also thereby ensuring more access to affordable quality medicines. 

This, in turn, can help fight worrisome trends like antimicrobial resistance (AMR) – which the continent has little capacity to track or tackle right now, according to one recent study of 14 countries.

According to a new African Union Framework for AMR Control, the nascent AMA will promote a common scheme for prohibiting the sale of non-standard antimicrobials, whose use can foster drug resistance, backed by post-marketing surveillance. 

In the context of the framework, the AMA will contribute to strengthening laboratories for drug quality control and promote education of pharmacists in identifying sub-standard or falsified drugs, using innovative tests to measure drug quality, while also encouraging policies that promote availability of genuine, safe and effective products at competitive prices.

The Framework also promotes collaboration with governmental and non-governmental partners (including community groups) to increase awareness among not only clinicians and pharmacists but also veterinarians and animal and crop producers about substandard and falsified antimicrobials.

For full coverage on the development of the African Medicines Agency, see our AMA Countdown Page here: 

https://healthpolicy-watch.news/african-medicines-agency-countdown/

Image Credits: @elmimuller, Kenyan Parliament website, South African Parliament.

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