Transparency data

Annual accountability review minutes 2021 to 2022: 12 July 2022

Updated 19 January 2024

Chair, secretary and attendees

Chair: Lord Syed Kamall, Parliamentary Under Secretary of State – Minister for Technology, Innovation and Life Sciences (Department of Health and Social Care).

Secretary: Yetunde Agaga, Private Secretary – Parliamentary Under Secretary of State (House of Lords).

Attendees:

• Dr June Raine DBE, Chief Executive, Medicines and Healthcare products Regulatory Agency (MHRA)
• Stephen Lightfoot, Chair (MHRA)
• Glenn Wells, Chief Partnerships Officer (MHRA)
• Rose Braithwaite, Deputy Director of Finance (MHRA)
• Carly McGurry, Director of Governance (MHRA)
• Head of Governance, Risk and Assurance Governance Office (MHRA)
• Liz Woodeson, Director of Medicines (DHSC)
• Kathryn Glover, Deputy Director of Medicine Regulation and Prescribing (DHSC)
• Senior Policy Manager, MHRA sponsor (DHSC)
• Senior Policy Advisor, MHRA sponsor (DHSC)

Opening remarks

Lord Kamall started the meeting by thanking Dr Raine and Mr Lightfoot for the opportunity to speak at the One Agency Live event, which celebrated MHRA’s move to its new-look organisation.

Lord Kamall also congratulated Mr Lightfoot on his successful reappointment as chair of MHRA, starting from September 2022.

Recognising it was a busy and challenging year for the organisation, Lord Kamall asked Dr Raine and Mr Lightfoot to pass on his sincere thanks to all MHRA staff for their continued hard work over the last year.

Review of progress in 2021 to 2022

Dr Raine provided a summary of key achievements and objectives delivered in the first year of MHRA’s 2-year Delivery Plan 2021 to 2023, which included:

• learning from the coronavirus (COVID-19) response to implement regulatory flexibilities without jeopardising patient safety
• making significant progress in implementing the new organisational structure as part of the transformation programme. The last vacancies are largely in technical roles and those will be filled by October 2022
• developing the Innovative Licensing and Access Pathway (ILAP) to accelerate the time to market in partnership with the National Institute for Health and Care Excellence (NICE), Wales and Scotland. To date, ILAP has received over 120 applications
• creating and completing the Northern Ireland MHRA Authorised Route (NIMAR), a new supply route that ensures people in Northern Ireland can continue to access supply of prescription-only medicines to meet clinical need
• successful development of polio vaccines, developed in conjunction with academic partners, to tackle overseas polio outbreaks
• with DHSC, preparing new legislation setting out its post-EU approach to regulation, including on clinical trials
• transitioning from a trading fund with DHSC support

On delivering the key objectives of the first year of the Delivery Plan, Dr Raine set out the focus on enabling MHRA to adapt to the new regulatory environment in order to develop new services and embed patient involvement. Mr Lightfoot added that the work during the first year of the Delivery Plan had laid the foundation to embed the changes to improve patient involvement, patient safety and access, and to enable innovation. The benefits of this work will be realised throughout the second year of the plan.

On partnerships, Mr Wells highlighted the work on building effective partnerships with national and international partners, striking the right balance between alignment and being an innovative regulator. This is demonstrated by the success of bringing promising drugs to patients through Project Orbis and the early access to medicines scheme, which was put on a legal footing in early 2022.

On finances, Dr Raine highlighted that following the outcome of the Spending Review and further to the loss of the trading fund status from 1 April 2022, the Spending Review settlement will support MHRA to deliver its challenging agenda, including on technology.

Review of upcoming deliverables in 2022 to 2023

Dr Raine and Mr Lightfoot confirmed the key priorities for MHRA for the upcoming year.

In the second year of the Delivery Plan, Dr Raine confirmed the focus will be on making the organisation come alive, embedding new services that will reduce their timeframes and developing MHRA’s culture, as well as completing transformation with a focus on developing staff. MHRA will also focus on inclusivity and contributing towards reducing inequalities in healthcare.

Mr Lightfoot reiterated that, while the first year’s focus was on setting the strategy and structure, the second year will focus on ensuring MHRA embeds new ways of working to deliver lasting change. This will include investment in new IT systems, cultural change and service redesign.

Lord Kamall acknowledged MHRA’s continued hard work to progress the Delivery Plan and welcomed MHRA’s approach to innovate while ensuring efficiency. Similarly, Ms Woodeson was pleased to hear the focus will be on continuing to ensure efficient service performance.

Dr Raine clarified that patient involvement is a priority, as set out in the strategy, and work is underway to map out where and how patients can be increasingly involved. Metrics are currently being introduced to enable the measure of success with regard to engagement with patients.

On partnerships, Mr Wells added that work continues to solidify relationships with international partners. Ms Woodeson reiterated the importance of working with system partners, in particular NICE and Scottish and Welsh partners on ILAP matters. Dr Raine agreed and set out the work underway with NICE and the wider NHS.

Concluding remarks

Lord Kamall commented that he was impressed by the focus on people and particularly how the leadership had managed to effect such change.

He concluded by thanking MHRA once again for its work to date.