Annual accountability review minutes 2020 to 2021: 22 July 2021
Updated 19 January 2024
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Chair and attendees
Chair, Lord James Bethell, Parliamentary Under Secretary of State – Minister for Innovation, Department of Health and Social Care (DHSC).
Attendees:
- Stephen Lightfoot, Chair, Medicines and Healthcare products Regulatory Agency (MHRA)
- Dr June Raine, Chief Executive (MHRA)
- Jon Fundrey, Chief Operating Officer (MHRA)
- Rachel Arrundale, interim Director of Policy (MHRA)
- Elizabeth Woodeson, Director of Medicines (DHSC)
- Helen Lovell, Deputy Director of Medicine Regulation and Prescribing (DHSC)
- Dunia Alameddine, Senior Policy Manager, MHRA Sponsorship (DHSC)
- Laura Dunkling, Private Secretary (DHSC)
Opening remarks
Lord Bethell started the meeting by thanking Dr June Raine, Stephen Lightfoot and all MHRA staff for the work over the past year. Lord Bethell acknowledged that, despite the challenging times, the MHRA has played a key role in responding to the COVID-19 pandemic, made substantial progress on its Transformation Programme, and published its Delivery Plan. Dr Raine highlighted the collaborative relationship with the Department that helped make these happen.
Review of progress in 2020 to 2021
Dr Raine provided a summary of key achievements.
On patient involvement, every staff has a personal objective to deliver meaningful and relevant outcomes to patients, and work is ongoing to ensure the commitment to involve patients at every step of the way is embedded in the MHRA’s culture.
Liz Woodeson reiterated the importance of having robust and consistent measurements of success. Dr Raine agreed and gave reassurance that measures will be agreed with patient involvement with the aim of developing quantitative and qualitative evidence by next year.
On patient safety, the MHRA’s safety systems have been able to rapidly detect signals from patients and healthcare professionals. The MHRA has continuously engaged with these communities and work is underway to explore how the safety systems can enable an improved risk-benefit assessment of medical products. Dr Raine highlighted the ongoing engagement with patients and campaign groups to discuss isotretinoin, a treatment for severe acne, as an example of how these processes are now working.
On innovation, Dr Raine mentioned the success of the Innovative Licensing and Access Pathway (ILAP), whereby the MHRA has recently awarded an ‘Innovation Passport’ for a treatment for sickle cell disease, a rare blood disorder. Dr Raine highlighted that ILAP may be extended to include more products other than medicines.
Lord Bethell reflected that a key theme of the Life Sciences Vision is working more closely with the NHS, and facilitating adoption of innovative medicines and MedTech, and asked that the MHRA consider taking on a more prominent role as part of the Vision. The scope for Clinical Practice Research Datalink (CPRD) data to be used to support more appropriate clinical decision making in primary care was discussed.
Financial sustainability
Dr Raine summarised the key steps towards financial sustainability, which include:
- developing a new fee strategy for a smaller and more agile organisation
- a robust Spending Review bid for areas that cannot be entirely covered by fees
- a comprehensive refresh of the MHRA’s technology
Ms Woodeson flagged that the MHRA has indicated that it will no longer be able to spend all its reserves before it ceases to be a trading fund in April 2022. Ms Woodeson asked how the MHRA is ensuring it has the financial planning and management capability to deliver against the new financial framework. Mr Fundrey confirmed that this is being done through several changes to the operating model, which will include the replacement of IT systems, the reduction of corporate costs and a review of the fees’ policy. Mr Fundrey also highlighted the introduction of a new monthly budgeting system that will allow a real-time understanding of MHRA’s profitability by service as well as enabling work-force planning. Mr Lightfoot mentioned the role of the board in monitoring the organisation’s performance and cited the use of a balanced scorecard.
For further reassurance on its financial sustainability plan, Lord Bethell asked that the MHRA work very closely with the department. To address this, Mr Fundrey confirmed that the MHRA will have more frequent meetings with the Department, moving from quarterly to monthly, whereby financials and forecasts will be shared regularly. Lord Bethell and Ms Woodeson endorsed this approach.
Concluding remarks
Lord Bethell concluded the meeting by inviting any final comments on the MHRA’s objectives. Ms Woodeson reiterated the importance of ensuring that all ‘business as usual’ activities and key deliverables are not affected by the Transformation Programme, and that the MHRA’s senior leadership team ensure that the culture change is embedded across all levels of the organisation.
Lord Bethell agreed and thanked the MHRA once again for its work to date.