Transparency data

Annual accountability review minutes 2019 to 2020: 27 November 2020

Updated 19 January 2024

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, interim Chief Executive (MHRA)
• Jon Fundrey, Chief Operating Officer (MHRA)
• Jonathan Mogford, Director of Policy (MHRA)
• Elizabeth Woodeson, Director of Medicines and Pharmacy (DHSC)
• Alastair Hardisty, Head of MHRA Sponsorship and EU Exit (DHSC)
• Dunia Alameddine, Senior Policy Advisor, MHRA Sponsorship (DHSC)
• Eloise Kohler, Senior Private Secretary (DHSC)

Opening remarks

Lord Bethell gave a warm welcome to Stephen Lightfoot, chair of the MHRA since 1 September 2020.

Review of progress in 2019 to 2020

Dr Raine provided a summary of key operational indicators, including on the volume of licensing applications for innovative medicines and generics received to date.

Dr Raine also set out an overview of the key achievements by the MHRA over the past year, highlighting:

• the excellent work of the National Institute for Biological Standards and Control (NIBSC) on standards and vaccines
• the increased gathering of anonymised data by Clinical Practice Research Datalink (CPRD) so it is more holistic and responsive
• the proactive work on increasing awareness to patients and the public on the use of opioids
• the work of enforcement and international cooperation to tackle the supply of fake and counterfeit medicines
• the increasing number of Yellow Card reports by patients

On Yellow Card, Mr Lightfoot added that it is an opportunity for the MHRA to use the scheme to build up the dialogue with patients.

Lord Bethell thanked the MHRA for its hard work and achievements last year, reiterating the importance of ensuring patients have access to safe and innovative products.

COVID-19

Dr Raine provided an overview of the key actions by the MHRA to help fight the COVID-19 pandemic.

Dr Raine also highlighted the work on regulatory flexibilities, which have received positive feedback from the industry and the NHS. Mr Lightfoot added that COVID-19 response has shown the importance of becoming more outward facing and proactive.

Moving forward, Dr Raine expressed the MHRA’s commitment to maintaining the partnerships established along the way and building on the global position that the MHRA has developed during the pandemic.

Lord Bethell thanked the MHRA for its work responding to COVID-19, and praised its regulatory approach for its agility and action.

Financial sustainability and MHRA change

Dr Raine provided an update on the Change Strategy, which will set the path for the MHRA towards financial sustainability in the light of EU exit and the change in status from trading fund to regulatory body. Mr Lightfoot added that there is a cultural change in process to deliver the strategy, and set out the key changes, including in relation to the leadership at the executive level.

Jon Fundrey provided an update on the MHRA’s finances. The total trading income in 2019 to 2020 was around £150 million, lower than previous years primarily due to a reduction in EMA-related work. As the MHRA develops its plans towards financial sustainability, Mr Fundrey highlighted that IT and business-as-usual costs will be driven down after the retendering of contracts, but there will be additional expenses to deliver the strategy. Mr Fundrey added that the MHRA’s reserves will be used to drive some of the change. Mr Fundrey also highlighted that the work on establishing a new fees’ structure and a sustainable funding model are key components of the strategy.

Dr Raine emphasised she is confident that the strategy can be delivered, but recognised the existing challenges due to a tight spending review settlement.

Forward look

Mr Lightfoot provided an update on the MHRA’s strategic objectives going forward, highlighting the development of new, refreshed priorities, including:

• ensuring patient safety
• enabling healthcare access
• building dynamic organisation
• delivering financial sustainability

Lord Bethell welcomed these objectives, and asked the MHRA to continue to focus on patient safety as it develops its innovative regulation offer. In addition, Lord Bethell asked the MHRA to develop options on opportunities for further collaboration between international regulators.

Finally, Lord Bethell thanked the MHRA for its work on the Medicines and Medical Devices Bill, highlighting the opportunities that can result from its passage.