EU EXCLUSIVE, Gates Foundation to support African Medicines Agency -source

  • The treaty establishing the regulator entered into force in November
  • The pandemic has revealed Africa’s dependence on imported vaccines
  • Regulator may be similar to European Medicines Agency – WHO
  • The agency can fight against fake certificates, drugs, masks, medicines -AU

BRUSSELS/CAPE TOWN CAPE TOWN, Feb 11 (Reuters) – 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 production of medicines and vaccines on the continent, said a person familiar with the matter. Reuters.

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

Financial and technical support to the new agency is considered crucial to help it start its activities. This would in turn boost the continent’s vaccine and drug industry, which needs a trusted regulator to thrive.

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

The goal is to enable these agencies to achieve what the World Health Organization (WHO) defines as maturity level 3 for vaccine production, which is “the minimum WHO requirement for a effective regulatory oversight of local production of quality vaccines,” the official said.

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

The EMA, which is so far the only continent-wide medicines regulator, “will provide technical assistance to African counterparts through scientific collaboration, joint inspections, trainings, including WADA,” indicates the document.

WHO Director-General Tedros Adhanom Ghebreyesus has urged African countries to support efforts to get the regulator in place as it could help tackle counterfeit or substandard medicines.

“I believe this institution will be very, very important for the continent,” he said in Cape Town. of WADA).

At an earlier event, WHO Chief Scientist Soumya Swaminathan said WADA could play “the kind of role that the European Medicines Agency has played in Europe – setting standards, helping countries to develop their regulatory agencies”.

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The race to establish the AMA comes after the COVID-19 pandemic revealed the region’s reliance 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 secure doses of the COVID-19 vaccine as wealthy countries grabbed limited supplies. Deliveries to the mainland then resumed, but only 10% of Africans are fully vaccinated.

Efforts are currently underway to increase production, but a regulator is needed to approve the drugs.

Experts say preparing for future pandemics is just one reason why a continental regulator is crucial for Africa.

Disparate regulations in 54 countries and insufficient transparency have led some pharmaceutical companies to abandon efforts to register their products, resulting in limited availability of important drugs in many African countries.

A lack of strict oversight has allowed counterfeit drugs to flood African markets, in some cases causing unnecessary deaths and fueling skepticism about the medicine.

EU efforts to support the new regulator are part of a broader strategy to control 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 over the past year.

Access to vaccines will also be a key issue at a summit of EU and African Union leaders next week in Brussels.

Senior AU official Margaret Agama-Anyetei, who is leading the effort to set up WADA, said getting more AU member states to sign and ratify the treaty is one most pressing priorities.

“Across the continent, there is a plethora of fake certificates, fake medicines, fake masks and fake medicines, and it is really important that we have a continental agency that is complementary 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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Reporting by Francesco Guarascio in Brussels and Wendell Roelf in Cape Town; Additional reporting by Edward McAllister in Dakar, Michel Rose in Paris, Ludwig Berger in Berlin and Giulia Paravicini in Addis Ababa Additional reporting and writing by Maggie Fick Editing by James Macharia Chege, Louise Heavens, William Maclean

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