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

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[February 11, 2022]  BRUSSELS (Reuters) - The European Union and the Gates Foundation are set to announce a package of financial support for the nascent African Medicines Agency (AMA) in a bid to boost the continent's drugs and vaccine production, a person familiar with the matter told Reuters.

The treaty establishing 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 race to establish AMA comes after the COVID-19 pandemic exposed the vulnerabilities of the region to health crises. Just over 5% of medicines, and 1% of vaccines, consumed by the population of 1.2 billion people are produced locally.

($1 = 0.8777 euros)

(Reporting by Francesco Guarascio @fraguarascio, Editing by Louise Heavens)

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