Tuesday, May 14, 2024


Reflections on Travel to Europe – Part Two

Our first stop on our recent European trip was London. Although the jet lag on the first day after crossing the Atlantic can be tough and the second day is often more trying, the trip was invigorating and thought provoking. The U.S. Food and Drug Administration’s Office of Global Policy and Strategy and Office of Commissioner staff did a great job arranging a busy schedule that covered multiple critical topics. We had an initial dinner with an eclectic group from the U.K. dealing with policies ranging from women’s health and diversity in clinical trials to the impact of the medical products industry on the economy to pandemic preparedness and response. We visited interesting and historical venues, like the Royal Academy of Medicine, for our meeting with the Medicines and Healthcare products Regulatory Agency, or MHRA, and closed with a trip to Oxford to engage with the academic clinical trials community.

It was challenging to absorb the impact of Brexit on the regulatory and healthcare systems of the U.K. Prior to-Brexit, the U.K. was a significant contributor to the European Medicines Agency (EMA) and the European system of medical product and food regulation. In fact, the EMA headquarters were located in Canary Wharf in London. Post-Brexit, rather than being part of a larger system, MHRA, which regulates drugs, biologics, and devices, and the Food Standards Agency, which regulates the food used in the U.K., primarily do so on their own. This is an enormous increase in work. The other side of the coin is the potential for the U.K. system to be creative to “meet the moment” without having to reach agreement with the diverse array of countries of the European Union. We heard a variety of interesting ideas about how to create a more effective regulatory approach, including reliance upon the work of other trusted regulators to inform their work and enhance their efficiency in the face of limited resources.

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