Hunt On For New Chair Of UK Regulator
Executive Summary
Whoever takes over as chair of the Medicines and Healthcare products Regulatory Agency will play a key role in its plans to deliver a program of “ambitious business change.”
A search has been launched to find a new chair for the UK’s Medicines and Healthcare products Agency to replace Sir Michael Rawlins. Sir Michael is stepping down from the post on 30 November when he will have served two three-year terms, the maximum time any one person can hold the position.
Applications are being invited from interested candidates until 17 March.
The job advertisement makes it clear that steering the agency through Brexit-related challenges will be a key task for the new candidate now that the UK has left the EU. It states, for example, that the new chair would be expected to deliver “significant changes to fundamentally reshape the way the Agency operates, including driving efficiencies throughout the business.”
The MHRA’s interim chief executive June Raine said this was a “pivotal time” in the agency’s history as it undergoes organizational transformation. “During the coming three years the Chair will play a key role as the Agency delivers an ambitious business change programme which will help maintain the UK as a global centre of excellence in medical science, in the best interests of patients and the public,” Raine said.
New MHRA Chief Executive Awaited
The hunt is also still on to find a permanent chief executive for the MHRA. Raine took charge in the interim after Ian Hudson stepped down from the post in September 2019. (Also see "UK Agency Boss Hudson Leaves Brexit Challenge To Successor" - Pink Sheet, 20 Nov, 2018.) While the agency was expected to start recruitment for Hudson’s successor early in 2019, the process was delayed. (Also see "Raine To Lead UK MHRA Ahead Of Permanent Head Announcement" - Pink Sheet, 20 Aug, 2019.)
An MHRA spokesperson told the Pink Sheet last month that the recruitment process for a permanent chief executive was still underway and that the Department of Health and Social Care would announce the successful candidate in due course.
MHRA’s Priorities
The agency’s new leadership comprising the new chair and permanent chief executive, when in place, will be tasked with furthering the regulator’s current priorities, namely to:
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- Lead the development of the UK’s approach to regulating medicines and medical devices following Brexit and strengthening the MHRA’s global role and influence. The UK has already made it clear that at the end of the Brexit transition period, it will be charting its own course in the field of medicines regulation. While it plans to retain the existing EU rules that have been transposed into domestic legislation, it wants the freedom to tailor its regulations in areas like clinical trials, advanced therapies and product labeling. (Also see "UK Reveals Plans For ‘Dynamic’ Post-Brexit Regulatory System " - Pink Sheet, 17 Feb, 2020.)
- Drive an ambitious transformation plan throughout the agency to deliver a more flexible and efficient organization, using state-of-art digital technology, so as to be able to respond effectively to market and customer requirements.
- Develop regulation that supports transformational innovation and the safe manufacture, sale and supply of medicines and medical devices.
- Support the government’s growth agenda through the UK’s life science strategy and sector deal commitments, which include early access to medicines schemes and the adaptive licensing pilot.
- Contribute to the system-wide response to the Independent Medicines and Medical Devices Safety (IMMDS) review, including a fundamental review of the MHRA’s engagement with patients and the public to improve public health and patient safety. The IMMDS review was ordered in February 2018 to explore how the health system responds to reports from patients about harmful side effects from medicines and medical devices. It followed patient-led campaigns on the use of the hormone pregnancy test Primodos, the anti-epileptic drug sodium valproate and surgical meshes. (Also see "'A Criminally Negligent Medical Device Regulatory System': UK Mesh News Provokes Outrage " - Medtech Insight, 11 Jul, 2018.) The final report of the IMMDS review is expected on 24 March.