Matching the jagged pieces of this bureaucratic puzzle requires keen-eyed, adult-level diplomacy and finesse, particularly in navigating a mandate that is unique among regulatory agencies. The EMA enables and coordinates, but does not control. It is—at least officially—politically autonomous, answering to a management board drawn from representatives of local registration authorities and the EU institutions. Day-to-day activities are driven by an extensive—and confusing—cross-subsidization of time, money, and effort among these diverse stakeholders.
The man of the moment for this task is EMA Executive Director Guido Rasi, a physician and microbiologist who assumed the post in October 2011 after three years as head of the Italian drug approval agency, AIFA. One of Rasi's assets was that he was no stranger due to his role in representing Italy on the EMA Management Board. This was important given the surprise disclosures of ethical lapses surrounding the departure in December 2010 of the second EMA Director, Thomas Löngrenn. In addition, Rasi had shown a deft hand in similar circumstances, leveraging family connections to the Berlusconi government to restore public confidence in AIFA after a 2008 scandal involving "pay-to-play" allegations against the previous management.Rocky start
Criticism over Löngrenn's move as a well-paid consultant for companies with business before the agency delayed the selection process that led to Rasi's appointment. The timing could not have been worse, as the leadership gap occurred in the aftermath of two well-publicized public health emergencies: one involving the failure of French drug-maker Servier to disclose life-threatening heart valve injuries from a diabetes drug it marketed as an appetite suppressant, and the other over the sale of breast implants known to be defective.
Although national authorities bore much of the blame for the toll in deaths and injuries, the two cases exposed serious gaps in the European legal armamentarium to protect the public health, especially once medical products are out on the market. A consensus quickly emerged that a broader regional approach was needed, and in due course the EMA found itself charged with oversight responsibility to coordinate and track the safety of all approved medicines and vaccines, including those secured via the decentralized procedure run by national agencies, through a European-wide strategy and program of pharmacovigilance.
This task alone might rightly be seen as all-consuming, given that the safety net EMA must erect covers a target community of more than 500 million patients. But Rasi confronts a more fundamental short-term challenge, which many observers of the agency now call "the two t's:" transparency and trust. Predictably, both are seen as being in short supply. EMA's paymasters in Brussels are insisting that Rasi put these at the top of his priority list to ensure that confidence in the integrity of the drug supply is maintained. "Credibility is the working currency of regulation, and EMA is no exception," Rasi told a recent Prix Galien Forum panel moderated by Pharm Exec.