The Sum of All His Parts: Career Reflections of Europe's Chief Drug Regulator - Pharmaceutical Executive


The Sum of All His Parts: Career Reflections of Europe's Chief Drug Regulator

Pharmaceutical Executive

Pharm Exec: Now that your tenure as Executive Director is ending, do you have any advice for the pharmaceutical industry going forward?

TL: Drug companies need to do a better job at linking their prospects to the treatment and prevention of disease—not just today but especially for the future. Association with the development of advanced therapies like tissue replacement and modification of the immune system through vaccines is vital.

Industry leaders also have to face the question of the limited resources available for health: Are we as a society spending these resources in the right way? This in turn requires the possibility of acknowledging that pharmaceutical interventions are often overvalued. The best tool to solve a health challenge could be something other than a drug. Process innovation is not recognized by the industry as a source of growth. Horizontal prevention strategies, designing devices along with drugs to facilitate improved diagnoses and raise the patient response rate—these are ripe for new approaches. The current business model has to yield to something more holistic.

Pharm Exec: What advice might you have for your successor?

TL: A firm commitment to transparency is critical to success in this position. Transparency is fundamental to trust. Trust is what fosters confidence in our networked authorization system and helps ensure that when there are problems, you have the political leverage to do what is right for public health. This is particularly important given the EMA's expanded remit in supervising the pharmacovigilance process. The next Executive Director will also have to keep pace with progress in science and technology. New areas of regulation are opening up; more needs to be done to clarify standards, as we are doing now for biosimilar antibody drugs, where we are specifying approaches to post-authorization followup studies to better ensure patient safety.

Pharm Exec: What are your plans for the "next life?"

TL: My plan is to remain active as an adviser and supporter of enlightened regulation—it's a force for good in society. How I plan to do this I will announce shortly.


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