Critics applaud EU Commission 'u-turn' on EMA

Shifting EMA oversight to DG Enterprise and Industry will put patients at greater risk of adverse events according to NGO Health Action International which suspects EFPIA "had a hand" in planned European Commission reshuffle. Critics of plans by European Commission President-elect Jean-Claude Juncker to remove oversight for the European Medicines Agency from the Commission’s Health and Consumer Directorate and give it to the Enterprise Directorate have welcomed reports that this move will not now take place.

The Party of European Socialists (PES) says reversal of the proposed policy has been negotiated with Mr Juncker by the “Socialist family” in the European Parliament. “We stood up for patients’ rights and made sure that this will continue to be the most important consideration in EU [European Union] healthcare policy,” said PES president Sergei Stanishev.

The Greens/European Free Alliance (EFA), which had opposed the move of responsibility for EMA to DG Enterprise, said that “the lobbying of the pharmaceutical industry has not been successful thanks to the responsiveness of the European Parliament but also through effective advocacy of patient organisations.”

“Medicines and medications are clearly not like other goods and patients must be placed before profit. Ensuring the Commission’s Directorate General for Health and Consumers [DG SANCO] remains responsible for the EMA is the only way to ensure this,” said the group’s health spokesperson, Michele Rivasi.

Also welcoming the reported reversal of the decision was the European consumers’ organisation BEUC. “If confirmed, it means our efforts have borne fruit. Moving oversight of drugs and medical devices to industry departments would convey the message that the Commission puts profits before patients. But the early opportunity is there to show the Juncker Commission will be responsive and pragmatic,” says BEU director general Monique Goyens.

The European Public Health Alliance (EPHA) also applauded Commissioner-elect Juncker’s “flexibility” which, said EPHA president Peggy Maguire, indicates that “he indeed recognises that medicines are not an ordinary internal market good and that pharmaceutical policy is crucial to the sustainability of health systems.” 

 

Following confirmation of the decision, the Commissioner-designate for health and food safety, Vytenis Andriukaitis, “would have the tools to facilitate his mandate to harmonise pharmaceutical governance within the EU and facilitate emergency preparedness – the very reasons that led the European Commission to move responsibility for medicines and medical devices to DG SANCO in the first place,” Ms Maguire added.

 

Source: Pharmacy Times