Feature European Medicines Agency

Sunshine at the European regulator

BMJ 2012; 344 doi: https://doi.org/10.1136/bmj.e976 (Published 15 February 2012) Cite this as: BMJ 2012;344:e976
  1. Elizabeth Sukkar, freelance journalist
  1. 1London
  1. lizsukkar{at}hotmail.com

As FDA transparency procedures move across the Atlantic to the European Medicines Agency, Elizabeth Sukkar talks to the agency’s new executive director about how it will cope

Professor Guido Rasi is tall, tanned, and likes to go swimming and sailing. While the view of the Thames from his Canary Wharf office may remind him of these hobbies, he will be hard pressed to find time for them as he makes the European Medicines Agency more open and transparent.

The agency, which was set up in 1995 and is 80% funded by industry fees, has been criticised in the past for not providing enough access to clinical data for drug researchers and for being secretive over its decision making processes for medicines.1

It has been (and still is) subject to inquiries by the European ombudsman over access to documents and is being investigated by the EU anti-fraud office in relation to the withdrawn anorectic drug benfluorex, the continued licensing of which resulted in a revamp of the regulatory landscape in France.2 3

“The more we are transparent, the more we will be able to communicate to the people, to build trust,” the 58 year old Italian says. Before taking up his post at the EMA three months ago, he was head of Italy’s drug regulatory agency (AIFA), where he replaced the previous sacked director general in 2008.4

He thinks the EMA has done well on its drug safety record, but “of course, there is a lot of room for improvement.” He points to the “tremendous opportunity” provided by the new pharmacovigilance legislation that comes into force in July to strengthen EU drug safety monitoring.

The legislation creates a new agency committee—the Pharmacovigilance Risk Assessment Committee (PRAC)—to look at drug safety concerns for nationally and EU approved medicines. Importantly, …

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