Annual accountability review minutes 2022 to 2023: 3 July 2023
Updated 19 January 2024
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Meeting attendees
Attendees were as follows:
- Minister Will Quince
- Private Secretary, Department of Health and Social Care (DHSC)
- June Raine, Chief Executive, Medicines and Healthcare products Regulatory Agency (MHRA)
- Stephen Lightfoot, Chair, MHRA
- Rose Braithwaite, Chief Finance Officer, MHRA
- Kathryn Glover, Deputy Director, Medicine Regulation and Pricing, DHSC
- Senior Policy Manager (MHRA sponsorship), DHSC
Opening remarks
Minister Quince opened the meeting and offered sincere thanks to Mr Lightfoot for his work with MHRA over the last 8 years, as this was Mr Lightfoot’s final review meeting.
Mr Lightfoot reflected on the growth in the relationship between DHSC and MHRA over his tenure.
The minister also recognised the work of all those in MHRA over the last year.
Review of progress in 2022 to 2023
Dr Raine provided a summary of MHRA’s achievements and performance in the last year, which included:
- increasing access to therapeutics, vaccines and diagnostics for COVID-19, extending coverage for different age groups and variants of the virus
- launching the Innovation Accelerator service to provide innovators better access to scientific and regulatory expertise
- chairing the ACCESS Consortium to enable rapid access to innovative medicines for UK patients through work-sharing initiatives, while moving the Early Access to Medicines Scheme onto a legislative footing
- developing the first phase of an international recognition framework, working closely with Australia, Canada, Switzerland, Japan, Singapore and the USA
- implementing a new One Agency structure, capable of operating as a proactive, world-leading regulator, supported by a new fees structure to fully recover costs
Dr Raine highlighted that MHRA achieved more than 70% of its objectives for the 2022 to 2023 year and the remainder have been reviewed and, if still relevant, carried forward into the new corporate and business plans for 2023 to 2024.
The minister asked what plans MHRA had to develop the recruitment of specialist staff.
Mr Lightfoot shared MHRA’s plans to invest in longer-term staff development and develop a pipeline of talent via graduate schemes. He also reflected on the practical reality of working with industry to source specialist secondees and develop fellowships.
Finance
The Chief Finance Officer of MHRA, Rose Braithwaite, highlighted the progress MHRA had made in its first year since ceasing to operate as a trading fund.
Mr Lightfoot reflected that MHRA had achieved a balanced operating budget and had not overspent.
MHRA will continue to review its operating costs and opportunities for expanding charging in future (where feasible to do so).
The minister advised that the impact of any new charges on small, medium and micro businesses should be considered in any plans.
Review of upcoming deliverables in 2022 to 2023
Mr Lightfoot set out the main aims of the MHRA corporate plan for 2023 to 2026. He highlighted the need for transparency in the work of MHRA in continuing to maintain public trust, as well as the need for consistency in the performance of the agency.
MHRA will look to develop its working partnerships across the government health family.
The minister asked what MHRA colleagues saw as the key priorities for the next year.
Dr Raine highlighted the immediate need for MHRA to meet its statutory licensing commitments for clinical trials and established medicines.
Mr Lightfoot added that MHRA have multiple statutory changes planned in the next year, with the aim of developing leaner statute, to be supported by extensive guidance for industry.
The development of MHRA’s regulatory management system (IT upgrades) will be a key workstream in establishing future efficiency and operational success of the agency.
Closing remarks
The minister thanked attendees for the discussion and closed the meeting, remarking on the fantastic scientific work he had seen when he visited the National Institute for Biological Standards and Control, and stating that MHRA should be proud of the world-leading work it conducts and not be shy about sharing its successes.