CEO of UK drugs regulator quits, as Brexit nears

The CEO of the UK’s medicine regulator has announced he will leave his post in September next year.

With just months to go before the Brexit deadline, Dr Ian Hudson, who has worked at the Medicines and Healthcare products Regulatory Agency (MHRA) for 17 years, said he was stepping down for ‘personal reasons’.

Dr Hudson said: “My reasons for stepping down are both personal and professional. I had always intended to reduce my total work commitment to enable me to pursue other things and perhaps have more of a portfolio career by the time I reached 60, which has now happened.

“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.”

Ian Hudson

To date, the government, which is still hammering out exactly what will happen, insists that Brexit will have no negative fallout.

The draft withdrawal agreement presented by prime minister Theresa May earlier this month stated that the UK would fall under the EU medical regulation process until the end of a proposed transition period.

It added that the MHRA would not be able to act as the leading authority for new risk assessments, approvals or authorisations of drugs and medical devices during this period, but would have to implement the outcomes of any assessments.

The uncertainty prompted the MHRA to consult in October on whether it can become a standalone body; the consultation period ended on November 1 and the results are being analysed by the government.

The agency said it wants the UK’s regulatory processes for medicines, clinical trials and medical devices to be legally coherent on exit day.

Speaking in October, Dr Hudson stressed that the MHRA wanted to retain strong links with the EU so that patients have timely access to medicines and medical devices.

He said: “We want to retain a close working partnership with the EU to make sure patients continue to have timely access to safe medicines and medical devices. However, it is important for the UK to prepare for all scenarios and this consultation is a key part of that.”

Recruitment for Dr Hudson’s successor will begin early next year, so that a handover can be arranged once an appointment has been made.