Exclusive-EU, Gates Foundation to support African medicines agency -source By Reuters

By Francesco Guarascio and Wendell Roelf

BRUSSELS/CAPE TOWN (Reuters) -The European Union and the Gates Foundation are set to announce a package of financial support for the nascent efforts to set up an African medicines regulator in a bid 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. Decisions over who will lead the agency and where it will be headquartered are scheduled for this year.

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 the only continent-wide drugs regulator so far will “provide technical assistance to African counterparts via scientific collaboration, joint inspections, training, and notably the AMA,” the document says.

The World Health Organization’s chief scientist, Soumya Swaminathan, said on Friday the AMA was crucial.

“It is very important. The African Medicines Agency can play the kind of role that the European Medicines Agency has played in Europe – setting the standards, helping countries develop their regulatory agencies,” she said in Cape Town.

ENDING DEPENDENCE

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 underway 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 China and Russia for influence in Africa, bloc officials in Brussels told Reuters. Brussels has donated hundreds of millions of COVID-19 doses to Africa in the past year.

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

So far less than half of the African Union (AU) member states have ratified the treaty setting up the AMA.

A senior AU official, Margaret Agama-Anyetei, is currently leading efforts to set up the AMA. Getting more AU member states to sign and ratify the treaty, choosing which nation will host the headquarters, and the selection of the director general are the most urgent priorities, she said.

“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.

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