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: What was most critical in helping you cope with this list of expanded responsibilities? What learnings do you draw from a process that demanded doing more without a large offsetting increase in resources?

TL: Focus is important. It was always the priority to maintain the Agency commitment to its stipulated review timelines—a maximum of 210 days from launch of review to a decision, subject to the stop clock proviso where additional data is needed from applicants. That pushes the average timing between the start of the review procedure to adoption of a recommendation to around 310 days. If our record faltered, then we would be vulnerable politically and I knew that would impair our freedom to implement all these new duties in a way that made the most sense. We have kept that commitment for 15 years. It is a significant accomplishment.

There were other factors that helped us. First, we were able to rely on expertise provided through the national authorities. The challenge was handling logistics and minimizing overlap and bureaucracy. The role of the Agency's Management Board in integrating and prioritizing the various interests—and knocking heads where necessary—kept us at pace with expectations in Brussels and the national capitals. Second, the Agency has a stable financial base due to the application fee system, which is largely paid for by industry and accounts for about two thirds of our € 200 million ($262.1 million) annual budget.

The third factor I'd cite is the "road map" process to clarify where I wanted to take the organization and to bring in others for consensus around resources. I knew that relying on the language of the EU statutes to guide us would not serve as a rallying point—the rules told us what to do, but not necessarily how. And I have always been struck by the way the ground moves so quickly beneath us; medicines regulation is a dynamic field. Leadership demands we prepare for the unpredictable—that "shot across the bow" that, if we are not ready for, can imperil the lives of thousands of patients. We've done two such road maps—the latest carries our work forward to 2015—and the process has been invaluable in cementing our value proposition to the outside world. This in turn has had a positive impact on internal morale, especially in helping people cope with change. Some colleagues in Brussels failed to grasp the point of the "road map" exercise, but I'd say now their view has changed.

Pharm Exec: The first "road map" covered the period from 2005 to this year. Now that it's largely complete, where were the successes and the gaps?

TL: We achieved progress in three key areas, each of which was based on a close assessment of the environment for drug approval. One was the review of all our policies to benchmark whether they added to or detracted from the capacity of industry to conduct R&D, so that European patients would gain the clinical benefit from new therapies. The second was to rigorously test our commitment to the highest level of safety, including ways to encourage the rational use of medicines to reduce the incidence of adverse events and to secure better rates of compliance. Third, we re-examined the entire organizational structure to see how to improve the flow of information, to communicate with external constituencies more effectively, and to make transparency the basis for everything we do.

The one area where there is still a gap is transparency. Progress has been made but it is clearly a moving target. Compared to other agencies, we are ahead. But my sense is that here in Europe, our stakeholders are expecting more. For example, a better definition is needed to classify what is commercially sensitive information. The European Ombudsman believes that the Agency should widen access to documents, and in the last few weeks we have moved further in that direction, making a pledge to allow disclosure of all documents—including adverse event reports—within 15 days of a request, subject to the conditions of data protection. Another challenge is making sense of the enormous amount of data we generate on a daily basis. That data has to be transformed into useful information. It's not easy; you cannot just go to the bottom of the pile and say, "This will be public and this will stay confidential." Hence one of our objectives for the 2015 road map is to build the internal capabilities to leverage the volume of information productively.


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