Why An African Medicines Agency? Now More Than Ever!

“The future generations are not going to excuse this,” pleaded Kawaldip Sehmi, CEO of the International Alliance of Patients’ Organizations (IAPO). “They will be looking at us and will say, ‘What the hell were they doing procrastinating on their neighbors during a pandemic?”

Sehmi was one of seven speakers from across Africa who convened at an online session on Wednesday, the third and final day of the Africa Health Agenda International Conference (AHAIC), to discuss the prospects for near-term ratification of the African Union treaty to create an African Medicines Agency. a single centralizing regulatory body for pharmaceuticals in Africa.

The creation of the AMA was approved two years ago at the 32nd African Union Assembly, where it was touted as a critical tool that can enhance regulatory oversight of medicines and vaccines across the continent’s 54 countries. But the start of AMA operations have fallen victim to slow bureaucratic procedures in dozens of African countries that have foot-dragged in the required treaty ratification.  

The treaty has been signed by 19 countries but only ratified by eight out of a required 15 countries.  Meanwhile, the glaring absence of a body of this nature has only been more acutely felt during the COVID-19 pandemic, as the panelists highlighted.

Out of the continent’s 54 countries, 19 had signed the treaty ratifying for an African Medicines Agency (AMA), but only 8 out of the required 15 had ratified.

While IAPO’s Sehmi focused on the big picture vision of the AMA as the realization of a pan-African institution, epitomizing teachings of great African thinkers like Dr Kwame Nkrumah, the Ghanaian independence leader and first prime minister, other panelists detailed the nitty gritty  practical problems that AMA could help resolve  – focusing on the heart of concerns, African patients.

Take the case of sickle cell anemia.   Speaking at the AMA session, Mary Ampomah, President and CEO of the Global Alliance of Sickle Cell Disease Organisation (GASCDO) emphasized the critical role a body like AMA could play in helping sickle cell patients access more reliable and affordable drug supplies.  This has been a big problem in contempoary Ghana where, despite the existence of treatments like hydroxyurea for over three decades, patients could not access them prior to 2019 when Novartis finally intervened to create a supply channel for west African countries.

Mary Ampomah, President and CEO, Global Alliance of Sickle Cell Disease Organisations (GASCDO)

Going a step further, she asserted that the creation of a single regulatory authority would also help stimulate more local manufacturing – to supply a bigger market: “I think AMA will be helpful here because we know that when drugs are locally manufactured, they become cheaper and therefore accessible to patients,” she said.

Better regulation for Better Medicine

Oksana Pyzik, founder of the University College London Fight the Fakes,’ campaign, said that the AMA would assist in the “identification, prevention, detection and response strategies” in delivering quality medication across Africa. 

Oksana Pyzik, Senior Teaching Fellow, Global Engagement Lead and Founder of UCL Fight the Fakes

Pyzik spoke of how the COVID-19 pandemic had highlighted the need for a regulatory body such as the AMA to fill gaps and inconsistencies in the current patchwork of regulations that exist among the continents five regional regulatory authorities and dozens of national authorities. 

Citing the proliferation of false information surrounding the pandemic, which has affected people across the globe, she explained that in Africa “the lack of national regulatory and technical capacity has been one of the weak points around [the pandemic], fueled with misinformation that also then leads to people outside of traditional marketplaces, able to purchase medicines.”  This, in turn, places patients in grave danger – because they secure medications through channels where the products are not vetted and tested. 

Dr Eva Wangechi Mubia Njenga, Chair of the Non-Communicable Diseases Alliance of Kenya (NCDAK), further explained that the COVID pandemic has brought to a fore numerous “fake” products, including not only medicines, but also substandard personal protective equipment ( PPE), like masks, gloves, etc, which have entered into circulation.

Philip Tagboto – Chair of the Association of Ethical Pharmaceutical Industries – Moderates AMA Sesseion in the ”virtual space” of the Africa Health Agenda International Conference  2021

Fake vaccines, meanwhile, have already made their appearance.  In November 2020, some 400 ampoules of fake COVID-19 vaccines – equivalent to about 2,400 doses, along with a large quantity of fake 3M masks, were confiscated by police in South Africa working with the global police coordination agency, Interpol. The cross-border investigation led police in China to the manufacturing premises, where arrests of a number of Chinese nationals were made just last week – and a further 3,000 fake vaccines were seized. 

And Interpol Secretary General Juergen Stock said that this is only the tip of the iceberg when it comes to COVID-19 vaccine related crime. Efforts by bodies like the France-headquartered Interpol could be bolstered by AMA to support such cross-border successes, according to several panelists.. 

Through an Africa-wide regulatory body like AMA, processes like “market surveillance” and “supply chain security” could be implemented to better protect patients, Pyzik and other panelists stressed.

Big Pharma and Aid as ‘Gifts’ 
COVID-19 vaccines arrive in Guinea – distinguishing fakes from authentic vaccines could become a serious problem as Africa’s vaccine rollout amplifies.

Dr Njenga also said that Africa’s inadequate [regulatory] barriers have left it vulnerable to the possibility of authentic, but still substandard, ineffective or defective vaccines and medicines could enter the market, by way of “gifts”. In February alone, Guinea accepted a donation of 200,000 vaccines from China, which has offered vaccines to over 50 countries around the world – even though China’s vaccine developers have yet to publish peer-reviewed studies of any of their products, or submit them for review by stringent regulatory agencies abroad. 

Exacerbating the problem, said Njenga, is the fact that vaccine know-how is difficult to share and transfer – with big pharma compnies, mostly based in high-income countries,more  eager to sell their products to the highest- bidders – leaving low- and middle-income countries out of the loop. It’s thus no surprise that vaccines entering the continent are either “unregulated, or to a lesser extent, what doesn’t meet regulatory standards in the West is often offered or passed on to the African continent,” said Dr Njenga.

African Medicine for Africa, the World

Another important aspect of the AMA’s work may be improving the supervison and regulation of African traditional medicine, said Isaac Nii Ofoli Anang, chairperson of the African Regional Office of the International Pharmaceutical Students’ Federation (IPSF), “especially in a time when we want to improve access and safety traffic and traditional medicines to help augment their production and distribution across the continent.”

Isaac Nii Ofoli Anang, Chairperson, African Regional Office, International Pharmaceutical Students’ Federation (IPSF)

Anang said that for IPSF, AMA serves two key roles, that of education and that of science. With respect to education, as in the case of African traditional medicine, the agency would serve to streamline education of a medicinal regulation framework. 

Speaking about science, he said AMA would serve to harmonize the “scientific processes to improve on our local drug production and distribution pharmacies and pharmacies.”

Civil Society and Free Trade Concerns

With countries still stalling in the ratification process, Dr Njenga placed the responsibility on civil society to demand this continental regulatory body. 

She painted a grim picture of the alternatives, pointing to the double-edged sword of Africa’s recently agreed, Free Trade Agreement (FTA) which facilitates faster and more efficient trade across Africa’s countries. As pharmaceuticals are amongst the most traded products in Africa, in the absence of an AMA, the FTA could actually open the doors wider to the proliferation of poor quality and poorly regulated pharmaceuticals being trading across several borders with little to no control or recourse, to the potential detriment to all Africans.

Moving beyond the need for ratification, per se, however, she stressed that the next step needed for the AMA will be an “operational business plan.”

Image Credits: IFPMA, A, AHAIC, srb news.

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