Pharma, Policy

UK’s top drug regulator heads for the exit

Ian Hudson, CEO of the MHRA, will step down in September 2019. He cited the country's withdrawal from the European Union as a key factor.

EU Commission President Jean-Claude Juncker and UK Prime Minister Theresa May during a meeting at the EU headquarters in Brussels, Nov. 21, 2018

The head of the UK’s regulatory agency for health products plans to step down next fall, citing the country’s withdrawal from the European Union as a factor.

The Medicines and Healthcare products Regulatory Agency, or MHRA, said Wednesday that CEO Ian Hudson will leave his position in September 2019, after serving in the agency for 18 years. Recruitment for a new CEO will begin in early 2019.

While citing personal reasons as a factor, Hudson indicated in a statement that Brexit was a key reason. “I feel the time is right for a new person to guide the agency and our work through its next phase, following the UK’s departure from the European Union next year,” he said.

Brexit is set to take place on March 29, 2019, and the European Medicines Agency will move from its current headquarters in London’s Canary Wharf to Amsterdam. The EMA is the equivalent of the Food and Drug Administration for the EU as well as the three nations of the European Economic Area, namely Norway, Iceland and Liechtenstein.

Under a draft agreement released last week, there will be a “transition period” lasting from the date of Brexit until Dec. 31, 2020 – along with a potential extension through the end of 2022 – during which the UK will remain subject to EU rules and regulations, including those of the EMA, while the two parties finalize their trade relationship. The draft agreement will be up for a vote in the House of Commons next month.

The draft agreement drew praise from the Association of the British Pharmaceutical Industry, which said it welcomed the transition period because it would prevent a disruption in the drug supply. However, a related draft political declaration on the relationship between the UK and EU drew concern over what the group called its lack of clarity around how it will protect patients with respect to medicines’ safety, including data sharing between EU and British authorities and preventing fake or fraudulent drugs from entering the supply chain.

Photo: JOHN THYS, Getty Images

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