The European Medicines Agency (EMA) is a unique institution, pursuing a mandate shared with a complex web of national and
regional groups, each able to place a distinctive imprint around the delicate task of certifying the safety and efficacy of
new drugs. In return, the EMA has made a virtue of necessity. It filled the regulatory space opened by the relentless progress
of science and new information technologies to gradually expand its remit in a way that has maintained consensus among stakeholders.
In fact, the EMA has escaped the toxic politics that the US FDA is now mired in by securing a reputation for such predictability
that it attracts scant attention from headline-seeking media and the political classes, even as the issues that surround drug
approvals become more prominent and controversial.
Photo: Gideon Hart, London; Getty Images/Ian McKinne
Yes, there is bureaucratic merit to being boring, as reflected in the EMA's record of having achieved its prime commitment
to meet legislated review deadlines for new drug applications in every one of its 15 years of operation. Much of the credit
is attributed to the Agency's outgoing Executive Director, Thomas Lonngren of Sweden, whose five-year term—his second and
final, as required by statute—expires on Dec. 31. "Lonngren is not part of a revolving door; his tenure brought stability,
and in doing so he has kept the Agency independent," says industry spokesman Brian Ager, who is himself leaving the top job
at the European Federation of Pharmaceutical Industries and Associations (EFPIA) after 16 years. Quietly, without much fanfare,
Lonngren has made the EMA the "reserve currency" in global drug regulation, pursuing novel approaches to the evaluation of
pediatric and orphan drugs; risk management and conditional approvals; expedited pathways for advanced therapies; and partnerships
with industry around innovation, culminating in the €2 billion ($2.65 billion) Innovative Medicines Initiative (IMI) to speed
development of new standard-of-care therapies. Many companies now see the EMA as a better bet against the FDA "gold standard"
in obtaining a fair hearing without the political curveballs thrown by the many interests who see authorization as essentially
a lobbying exercise.
An advantage for Lonngren is that unlike the FDA, the Agency is autonomous. It does not report directly to the EU Commission
or the European Parliament but to a Management Board composed of a cross-section of institutions ranging from the member states
to the EU agencies and even patient representatives. In that regard, the European process remains in many ways an insider
game—you know which stakeholders count and how to target them.
However, expectations around the Agency are rising. There is no guarantee Lonngren's successor will be able—or suited—to pursue
his low-key Nordic approach, even if the next Executive Director comes from the national agencies (as is likely). Tighter
management of risk against the need to jumpstart pipeline innovation is a benchmark issue for Europe, just as it is for regulators
in the US. The Agency is inheriting from the member states more oversight on pharmacovigilance, which is certain to attract
more scrutiny from the European Parliament. Pressure will increase on the Agency to address the politically charged question
of why member countries have different levels of access to medicines, especially now that jurisdiction over the Agency has
shifted from the EU Commission's DG-Enterprise to the Public Health directorate, where activists enjoy more clout. Politics
also intervened in an unsuccessful effort to downgrade the job level, even as the function itself becomes more vital to the
EU's post-Lisbon treaty integration agenda.
With Lonngren now poised to move on—to a post advising governments, professionals, and the industry on the drug regulatory
process—Pharm Exec Editor-in-Chief William Looney sat down with him in London last month to review his record, sift through the next wave of
regulation, and highlight what's not on the industry's own reform agenda—but should be.