A person passes by on a scooter in front of the Bill & Melinda Gates Foundation in Seattle, Washington, U.S. May 5, 2021.
A person passes by on a scooter in front of the Bill & Melinda Gates Foundation in Seattle, Washington, U.S. May 5, 2021. Reuters / Lindsey Wasson

The European Union and the Gates Foundation are set to announce financial support for nascent efforts to set up an African medicines regulator to boost the continent's drugs and vaccine production, a person familiar with the matter told Reuters.

The treaty establishing the African Medicines Agency (AMA) came into force in November but the agency currently exists only on paper. So far just over half of the 55 African Union (AU) member states have ratified the treaty setting up the AMA.

Financial and technical support to the new agency is seen as crucial to help it to begin operations. This in turn would be a boost for the continent's vaccine and drugs industry, which needs a trusted regulator to flourish.

The European Commission, Germany, France, Belgium, and the Gates Foundation will invest more than 100 million euros ($113.93 million) to support AMA and African national regulatory agencies, a person familiar with the plan told Reuters on Friday.

The goal is to allow these agencies to achieve what the World Health Organization (WHO) defines as Maturity Level 3 for vaccine producing, which is "the minimum WHO requirement for effective regulatory oversight for quality local vaccine production," the official said.

According to an internal EU Commission document with slides, seen by Reuters, part of the money will be in grants and will also go to the European Medicines Agency.

EMA, which is as yet the only continent-wide drugs regulator, will "provide technical assistance to African counterparts via scientific collaboration, joint inspections, training, and notably the AMA," the document says.

WHO Director-General Tedros Adhanom Ghebreyesus urged African countries to back efforts to set up the regulator as it could help fight counterfeit or poor-quality drugs.

"I believe that this institution will be very, very important for the continent," he said in Cape Town. "I would like... to (appeal) to all countries who haven't ratified to ratify and speed up the establishment (of AMA)."

At an earlier event, the WHO's chief scientist, Soumya Swaminathan, said the AMA could play "the kind of role that the European Medicines Agency has played in Europe - setting the standards, helping countries develop their regulatory agencies."


The race to establish the AMA comes after the COVID-19 pandemic exposed the region's dependence on imported vaccines and other pharmaceuticals. Just over 5% of medicines, and 1% of vaccines, consumed by the population of 1.2 billion people are produced locally.

Africa initially struggled to get COVID-19 vaccine doses as rich countries snapped up limited supplies. Deliveries to the continent later picked up, but just 10% of Africans are fully vaccinated.

Efforts are now under way to increase production but a regulator is necessary to approve drugs.

Preparing for future pandemics is only one reason a continental regulator is crucial for Africa, experts say.

Disparate regulations across 54 countries, and scant transparency, have led some pharmaceutical companies to drop efforts to register their products, leading to limited availability of important medicines in many African nations.

A lack of stringent oversight has enabled counterfeit drugs to flood African markets, in some cases causing needless deaths and fuelling scepticism of medicine.

The EU's push to support the new regulator is part of a broad strategy to check Chinese and Russian influence in Africa, bloc officials in Brussels told Reuters. Brussels has donated hundreds of millions of COVID-19 vaccine doses to Africa in the past year.

Vaccines access will also be a key issue at a summit of EU and African Union leaders next week in Brussels.

A senior AU official, Margaret Agama-Anyetei, who is leading efforts to set up the AMA, said getting more AU member states to sign and ratify the treaty is one of the most urgent priorities.

"Across the continent there is a plethora of fake certificates, fake drugs, fake masks and fake medicine, and it's really important that we have a continental agency which is complimentary to all other national health institutions and invested in promoting the regulation of medical products across the continent," she told Reuters in a phone interview from the Ethiopian capital.

($1 = 0.8777 euros)