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.