Progress Report: Reflections on Rasi's First Year
Pharm Exec's Editor-in-Chief William Looney met with Dr. Guido Rasi on October 16—exactly one year after the 58-year old physician researcher
was handed the key to his sun filled Canary Wharf office as the agency's third Executive Director. In the following highlights
from that interview, Rasi expounds on his efforts to build an internal culture of trust and transparency, while keeping pace
with advances in scientific discovery and information technology as well as industry expectations for a seamless—and timely—approval
Pharm Exec: The EMA is in many ways a fragile institution, with a broad remit to advance access to medicines but a high level of dependence
on the cooperation of many constituencies. How important is trust to maintaining the external support that is so critical
to the successful execution of the EMA's mission? Can recent revelations of conflict-of-interest problems in the agency be
remedied by a quick fix of the rules or is a larger, long-term cultural change required?
Rasi: The EMA mandate is by law a decentralized one; we are not a "command and control" enterprise. Given the importance of the
EMA's function to approve medicines, our actions are closely monitored. Credibility—the organizational equivalent of trust—is
essential to our ability to function. If the medical community and our political institutions do not trust us, then our decisions
are not credible and from there it is a slippery slope to losing public confidence in the integrity and safety of the medicines
A strong commitment to transparency and ethical behavior has been the central objective of my first year as Executive Director.
Trust in the agency is not completely restored. But the progress we have made in opening up our procedures and raising the
bar on conflicts of interest means that trust is no longer an obsession among our colleagues in Brussels. I detect a friendlier
atmosphere at the European Parliament, where discussion is moving back toward the technical and scientific issues most appropriate
to our role as regulators.
The conflict of interest problems at the agency did not occur because we had no rules. The issue was one of perceptions, interpretation,
and enforcement. So what we did was reinforce the rules by improving day-to-day scrutiny on compliance. The rules now cover
not only contracted members of our expert committees, but all personnel, including the management board. This sent an important
message: that no one is exempt. Everyone now understands that ethical standards of behavior are embedded in the work routine;
it is part of the EMA culture.
Greater transparency is another way of exposing conflicts of interests before they impair trust in the organization. What
measures have you taken here?
Rasi: I have made a commitment to publish the minutes of all seven of our scientific committees by the end of 2013. It will be
easier to do this in some committees than others; clearly, the Committee on Human Medicinal Products [CHMP] must be careful
that what is disclosed will not confer a competitive advantage to companies active in the therapeutic areas under review.
We are also examining procedures to enforce actions against conflicts of interest involving all the scientific experts who
advise us on registration decisions. While it is true, as some critics contend, that we in management cannot take preemptive
steps by removing an expert who is in breach of the conflict rules, we can prevent that person from participating in decisions,
which solves 99 percent of the problem. This happens very rarely; our inability to fire at will actually provides a measure
of independence for the committees. It is a problem that is more theoretical than real.