Closing in on its second decade as chief arbiter of approvals for the world's largest drugs market, the European Medicines
Agency (EMA) is confronting that transitional stage of cranky adolescence, where the gap between expectations and performance
is widest. The agency spent its first years treading carefully through the minefields of EU politics, establishing its institutional
bona fides by compiling an enviable record of consistency in meeting legislated review deadlines (210 days) for new medicines.
That early success produced a torrent of demands to take on new responsibilities, resulting in a mismatch between mandates
and resources, followed—almost inevitably—by a perceived leadership vacuum, allegations of improprieties, and more outside
scrutiny of how the agency conducts its business. Today, the EMA is scrambling to adapt to a growing tendency to micro-management
by the European Parliament, not to mention the EU Commission and 27 EU member governments. Their instruction to the agency
is simple but sweeping: talk straight, play for value, and keep it safe.
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.
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.