African countries want to ensure the safety of medicines across the continent

She must not have listened carefully to the doctor’s advice, doctor Emmanuel Sosi initially thinks. In front of him sits the 56-year-old patient who arrived a few days ago with extremely high blood sugar levels in the small island clinic in western Kenya, right next to a beach where fishermen lift their loot from their wooden boats early in the morning. After Sosi brought the sugar in her blood to normal levels with an insulin drip, he sent her home with diabetes pills from an Indian manufacturer and a strict diet. Since then, he has checked her sugar level every morning, before eight, before her breakfast affects it. But it doesn’t go down. Not even after Sosi increased the dose of the diabetes pills.

Sosi decides to take a different approach. He prescribes the same drugs, but from a different manufacturer – and three times as expensive. “And yes, suddenly she had a good blood sugar level,” he says over the telephone. Sosi and his colleagues then looked at all diabetes patients in their file. There were fourteen, of whom eleven had unstable blood sugar levels after using the Indian manufacturer’s diabetes medications. “I was suspicious of the patient, but it was the pills I shouldn’t have trusted.”

One in ten medicines is fake or, the estimate is World Health Organisation. In some African countries this even applies to almost a quarter of the medicines. The WHO calculated that around 72,000 additional children per year will probably die due to poor antibiotics for treating pneumonia alone.

Sometimes too little of the active substance has been added – accidentally, or on purpose, because it is cheaper. In Zambia, for example, it turned out that a certain anesthetic from an Indian manufacturer was on average only half of the indicated amount of the anesthetic contained propofol. In other cases, substances are even added that can be harmful. Died between 2022 and 2023 more than three hundred children on several continents from drinking cough syrup containing toxic antifreeze and solvents, leading to acute kidney failure.

It is part of the problems that the recently launched African Medicines Authority (AMA) must prevent. This African equivalent of the European Medicines Authority () must guarantee the quality of and access to medicines throughout the African continent. 29 African countries now have the treaty ratified. With a head office in the Rwandan capital Kigali and the appointment of Delese Mimi Darko as director – who was previously the first female head of the Ghanaian Food and Drug Authority – the AMA can now officially start.

Become responsible yourself

“Although the organization has yet to achieve its first success, it is truly a success big deal that there is a consensus among so many African governments on the need for this, and that this is now becoming a reality,” said Fatima Suleman, professor of health sciences at KwaZulu-Natal University in South Africa, and expert on access to medicines.

The AMA should help assess medicines for safety, for the entire continent. It must establish quality standards that apply to all countries and organize joint inspections. Countries still decide for themselves whether to market a medicine.

Now drugs are approved by separate national drug authorities, which in many African countries do not yet meet WHO standards. National authorities can sometimes rely on pre-selection by the WHO, but this only exists for a small part of all essential medicines. Some countries, such as Ghana and Tanzania, are good at preventing and detecting poor-quality medicines. Other countries are less successful in this because they lack the money, personnel, technology or political will. The AMA must ensure that African countries exchange their practices and knowledge.

The AMA is also about autonomy, says Raffaella Ravinetto, professor of pharmaceutical public health at the Institute of Tropical Medicine in Antwerp. The AMA is “a logical next step in the decolonization process in the field of health,” says Ravinetto. “The important goal is for Africa to be responsible for its own health security in the long term.”

The AMA wants to ensure that more research is done in Africa and more medicines are produced locally, but also that these medicines are better tailored to African populations and to diseases that are common on the African continent.

Lack of clinical studies

Africa is the continent with the greatest genetic variety worldwide, but that diversity is barely represented in genetic datasets – where mainly Europeans prevent – or clinical studies. A little more than 1 percent of clinical trials preceding drug development are conducted on the African continent. As a result, medicines on the African market have often not been tested there.

“Clinical trials should assess how drugs work in a specific population and within a specific health system,” says Ravinetto. “Otherwise, too little account is taken of how African patients respond to medicines.” For example, Efavirenz, the standard drug against HIV until 2018, was eliminated from patients Zimbabwe and Botswana with certain genetic variants for side effects such as headaches, insomnia and hallucinations.

The AMA wants to pay extra attention to diseases that mainly occur on the African continent, such as malaria, sickle cell disease and Ebola. Relatively little research is currently being done into this, because the pharmaceutical industry mainly focuses on high-income countries where a lot of profit can be made from a patented medicine. Ebola is a good example of this, says Ravinetto: “The first outbreak occurred in 1976, but it was not until the outbreak some 40 years later that real investment in research was made, when there were fears that the disease would spread beyond Africa.”

PubMedthe largest database for medical studies, contains more than four times as many studies on multiple sclerosis (a partly hereditary condition mainly found in Western countries) over the past five years than on sickle cell disease (a hereditary form of anemia mainly found in African countries), while sickle cell disease kills hundreds of thousands more people every year, including children.

Local production of vaccines

Of the new medicines that came onto the market in the last five years, 43 percent are not available in any African country registered. Because manufacturers prefer to register their products in high-income countries, and due to insufficient financing by governments, access to medicines is a major problem in low- and middle-income countries. Many innovative medicines, such as those against cancer, are not available at all or are too expensive.

It is therefore not surprising that at the top of the goals list The AMA states that it wants to contribute to greater local production of medicines. Now African countries import more than 70 percent of their medications and even 99 percent of the vaccines. Manufacturers wanting to produce in Africa may now face slow approval procedures, regulations that vary from country to country, or a lack of medical infrastructure and factories in some countries. It is a myth that African manufacturers are not competitive, said CEO Stavros Nicolaou of the largest African drug manufacturer Aspen Pharmacare said at a conference in October, “but it is unacceptable that African manufacturers have to go through a six-year approval process before they can enter the market.”

The African Union wants to change this: by 2040, more than half of the vaccines must be in Africa produced. With an important role for the AMA, which must streamline the entire process. “If new medicines are registered regionally instead of nationally, pharmaceutical companies no longer have to wait a long time for approval in each country,” says Suleman. Moreover, a manufacturer will then be assured of a large sales market across the continent, Ravinetto adds. “A company can then produce larger quantities and therefore offer a better price while maintaining the same quality, which allows it to compete with, for example, Indian manufacturers.”

Corona made the situation urgent

Since 2009, the African Union has been discussing the creation of a body to monitor medicines. It may seem as if it took a long time for the AMA to be founded, especially since the European version EMA has been around for thirty years, but it actually happened relatively quickly, says Ravinetto. The first discussions about a European authority started thirty years before its official creation. Moreover, the African Union includes 55 countries, while the European Union has 27. “And there are greater differences between countries in how strong their current drug regulations are,” says Ravinetto.

Now 29 of the 55 countries have ratified the treaty. Support from as many countries as possible is a prerequisite for the success of the AMA, also financially. So far, the money for its establishment has mainly come from international donors, such as the European Medicines Authority and the Bill & Melinda Gates Foundation. But in the future, the agency will have to be paid for by the African Union member states, which will make an annual contribution.

The corona pandemic has made the establishment of the AMA more urgent for African countries, Suleman thinks. It then became painfully clear how unequally access to medicines is distributed worldwide. Western countries purchased corona vaccines en masse, while there was a huge shortage in African countries. The dismantling of USAID, the American foreign aid agency, resulting in, among other things, medicine shortages, was an additional wake-up call. Suleman: “African leaders have become more determined to provide sustainable health care on the continent themselves, without being dependent on other countries.”

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