Sector News

As Brexit nears, Britain’s drugs, devices and pricing regulators seek the exit

August 23, 2019
Life sciences

Firm details on exactly how the U.K. will regulate new medicines is still to be decided after it leaves the EU later this year (caveats on timing abound), but we now know that the regulator won’t be run by Dr. Ian Hudson, who is stepping down after six years in charge.

The Medicines and Healthcare products Regulatory Agency (MHRA) is the U.K.’s drug regulator, but most of the decisions on new drugs coming into use by U.K. patients have for decades come from the central European Medicines Agency (EMA), essentially sidelining the MHRA’s role as an approving body, with much of it work focused on drug safety. Although the agency could still make decisions on drugs for the country, most companies went through the EMA for quick access to the whole EU.

The MHRA’s role will likely dramatically change in the coming years, although it has worked very closely with the EMA for many years, given that until very recently, it was based in London. For now, the U.K. will pretty much follow the EMA’s drug rules, or at least that appears to be the current desire.

But with a new prime minister in Boris Johnson, an original supporter of Brexit, the U.K. is now more firmly set to leave the EU on Oct. 31 (yes, Halloween).

Hudson gave no reason for his departure, saying simply in a statement: “It has been a pleasure and privilege to have worked with so many able and committed people over the past 18 years. Our Agency makes a real difference to the health of millions of people in the U.K., Europe and beyond, and it has been an honor to make a contribution to this work.”

The agency has also said that John Wilkinson, the director of devices at MHRA, will be following Hudson to the exit after announcing his retirement a few months back. He’ll be gone in October.

The MHRA did not say whether Hudson would be seeking another role either in regulation or externally within the life sciences industry (which many do find themselves drawn to).

He will be replaced next month by Dr. June Raine. She is set to become an interim CEO, coming from a number of different licensing and post-licensing roles and serving as director of the Vigilance and Risk Management of Medicines division since 2006. She’s also chaired the European Pharmacovigilance Risk Assessment Committee on behalf of the EMA for six years.

Sir Michael Rawlins, chairman of the MHRA and former chair of the National Institute for Health and Care Excellence (NICE), said: “Dr Raine has spent her professional career in the Agency and its predecessor bodies. She is recognized as one of the leading experts in the field of medicines safety, playing a central role in the Agency’s work. I am delighted that she has agreed to act as interim chief executive of the Agency for the coming months.

“I would like to recognize the very substantial contribution that Dr Hudson has made to public health in the U.K., in Europe, and globally, throughout his 18 years with the Agency, including the last six years as chief executive.”

Coincidentally, this comes on the same day that Sir Andrew Dillon, chief executive of NICE for its entire two-decade life, also announced his upcoming departure from England’s drug pricing and value watchdog.

By Ben Adams

Source: Fierce Biotech

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