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The first woman to head up the European Medicines Agency in its 25-year history takes the reins as the EU reckons with the possibility of increased health powers.

Emer Cooke, director of the World Health Organizations regulation and prequalification department, was selected by the EMAs management board Thursday to take over from Executive Director Guido Rasi, whose term ends on November 15.

However, she will only be formally appointed after she gives a statement to the European Parliaments Committee on Environment, Public Health and Food Safety (ENVI) on July 13. After that, theres an overlap expected with Rasi, who has expressed his desire for a long handover period that gives him time to train his successor.

Cookes work at the WHO, where she has led the organizations work on the regulation of medicines, vaccines, diagnostics and devices, is praised by those whose job it is to be skeptical.

“Shes done very important work on regulation and quality at the WHO, which includes the WHO prequalification work,” said Ellen t Hoen, director of medicines law and policy and researcher at the University of Groningen. This work has been vital in the scale-up of low-cost generic medicines, she added.

Its “not just another high ranking civil servant,” said the European Public Health Alliances Yannis Natsis.

“The advantage of coming from the WHO is that she has contacts with regulatory agencies, because thats what her job involves,” said t Hoen. “So she will come with a tremendous international network.”

The fact that shes a woman is an extra bonus, said t Hoen, adding: “We need more health agencies run by women.”

Prior to the WHO, Cooke spent 14 years at the EMA as head of its inspections sector, as well as international liaison and, most recently, as head of international affairs. A pharmacist by training, Cooke began her career in the pharmaceutical industry in Ireland and then moved to the Irish regulatory agency. She has also worked at the European pharmaceutical lobby, EFPIA.

This experience in both industry and regulation brings “a well-rounded perspective” to her role, said Thiru Balasubramaniam, managing director of KEI Europe.

Its “not just another high ranking civil servant,” said the European Public Health Alliances Yannis Natsis, whos also a member of the EMAs management board.

The EMA “is one of the most powerful regulators in the world,” he said.

Greater powers

Cooke steps into the role when “public health in Europe is a turning point,” said Vincenzo Salvatore, a former general counsel for the EMA, now counsel at the law firm BonelliErede. “Theres a lot of discussion on transferring to the European Union more powers in the public health sector.”

As the pandemic wreaked havoc on health systems the world over, Europe at times struggled to work together — proof that stronger international coordination is needed, in Salvatores eyes.

Even Rasi admits that the EMA may have a larger role to play, particularly with regards to tackling drug shortages and building a network of clinical trials.

During the pandemic, Salvatore said, the EMA has been key in streamlining the approval procedures for potential drugs and treatments and in promoting research.

“I really have a lot of expectations [regarding] the skills and ability of the new executive director,” he said.

And its not just the EU giving greater powers to its agency. The EMA itself has beefed up its role.

The agencys political autonomy has “grown steadily” over the years, said Natsis, noting that Rasi himself has carved out a role that features “a high degree of autonomy, independence and flexibility.”

“Under his leadership, the EMA has grown in power and prestige,” he saiRead More – Source

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