Exclusive: MHRA Board Meeting, 20 September 2022

This video, currently exclusive to UK Column, was kindly recorded by a participant in the MHRA's September 2022 board meeting; the timestamped gist below is courtesy of our Nursing Correspondent, Debi Evans.

The full governance structure of the MHRA can be found here.

The timestamps are approximate and a guide only, and items discussed vary in length; hence, start times only are given.  

Start to 9 minutes – Introduction by Stephen Lightfoot, Chair of MHRA Board meeting – watch here for conflicts of interest and who is in attendance, and details of how many are watching remotely.

9:00 – CEO’s report: Dame June Raine on the agency’s priorities from her perspective

14:00 – June Raine – Work in progress

15:15 – June Raine – Public Trust – how joined up are we? – We are ‘getting there’

17:20 – Alison Cave, Chief Safety Officer, talks about Yellow Cards, NHS Digital, and signals [indications of problems]

18:10 – The delivery plan – What is MHRA ‘transformation’? How long will it take? – Stephen Lightfoot

23:00 – Interim Chief Finance Officer, John Taylor

26:20 – Mandy Calvert, Non-Executive Director, queries finances for quarter 4 of the year. John Taylor answers, but sounds unsure whether he can deliver.

27:50–33:00 – Enhanced Clinical Trials funding problems – discussion about finances not being in place

40:30 – Dr Laura Squire, Chief Quality and Access Officer, talks about active recording of MHRA staff to ensure they know what all staff are doing and to ‘track’ performance

42:00 – What staff are doing at the National Institute for Biological Standards and Control (NIBSC) Laboratory at South Mimms; how they are prioritising monkeypox

45:15 – Operational performance of the MHRA – how they measure and manage performance

49:40 – People and the MHRA – staff vacancies

50:20 – June Raine, CEO, discussing staff vacancies and how the MHRA is using headhunters to find suitable candidates

52:10 – Alison Cave on adverse vaccine reactions, signals and how hard MHRA staff are working

58:50 – Mandy Calvert: MHRA is currently 200 staff short, struggling to recruit. 74 voluntary leavers. She asks the question, “Don’t people like working here?” What is stopping people from working for the MHRA?

One-hour mark – June Raine responds: Many staff have postponed retirement in order to stay. We are looking at the problem of career potential in the short term.

1hr 1’ – Alison Cave on safety and surveillance: although staff quality is improving, with MHRA redeploying junior staff into more senior roles, filling the gap at the lower end is proving difficult

1hr 3:50 – Michael Whitehouse – Is the MHRA canvassing Members of Parliament for their opinion on the agency and to raise awareness?  What are they hearing from their constituents? MPs make interesting proxies; should the MHRA be contacting them?

1hr 4:45 – June Raine responds: It would bee good to get MPs’ opinions.

1hr 6:20 – Science, research and innovation

1hr 6:30 – Dr Paul Goldsmith: concerns about clinical trials and safety – Cumberlege Report

1hr 7:10 – Dr Mark Bailey: NIBSC Clinical Trial future – No-one seems to be able to answer a question! Very awkward. No one taking responsibility.

1hr 9:10 – Stephen Lightfoot – It's a work in progress

1hr 9:40 – Catherine Glover, Deputy Director Prescribing – Department of Health: how to ensure all bodies are working effectively. Strategic Research Executive. Anything the MHRA can do to help?

1hr 14’ – Dr Laura Squire – the work the MHRA is doing to improve performance. Approvals of licences. People, process and technology.
People – critical resource gaps: pharmaceutical assessors. Salaries are an issue, as staff need training. Non-clinical assessors struggling to recruit. How can the MHRA deal with immediate and long term issues?
Process – consistency; MHRA in continuing dialogue around consistency. Next workshop: definition of high-quality assessments.  What does it look like?
Technology – discussions started; getting people in post who can deliver.

1hr 19’ – Dr Laura Squire – reassuring Board of new drugs coming down the line, because everyone has been so focused on Covid-19

1hr 20’ – Dr Laura Squire – Referral of Critical Finding queries: do we have a problem? But is it critical? 

1hr 26:10 – Dr Alison Cave’s safety report – Surveillance, patient engagement; patients have integral role in work. Transformation of MHRA built with patient at the heart of all it does. What patients will see, new code of practice on conflicts of interest, experts remain impartial.
Patient engagement. Patient involvement strategy – patient input and patients’ views reflected. New benefits of the Yellow Card system. Additional information from patients. News feeds on Yellow Card.
Evidence-generating capabilities – pregnancy register – teratogenic [treatments that produce mutants]. Future medical device régime. Commit to work with patients and with the Patient Safety Commissioner.

1hr 29:50’ – Dr Paul Goldsmith – are plans are real or just an aspiration?

1hr 30’ – Dr Alison Cave: medical devices and safety. Tracking the patient journey, using registries and unique identifier numbers through registries. Working with NHS Digital. Not immediate, but there will be linkages across different bodies. Hopeful for future, but will take time.

1hr 32:30 – Catherine Glover – Impact of merger, NHS digitalisation, on patient safety issues not known – overhaul of governance

1hr 33’ – Prof. Graham Cooke – how do we detect the next ‘mesh’? Not confident in how the MHRA will do this.

1hr 33:45’ – Dr Alison Cave – new legislation, devices, surveillance – unique device identifier. Tracking the patient journey. Registries.

1hr 44’ – Stephen Lightfoot talks about ministerial decisions; mentions that S should stand for safety and should be included in the Health Secretary’s ABCD plan for the NHS.
Safety Connect: better capture, better interrogation of signals as they come through.
Patient engagement and listening to patients. What measures does the MHRA need to enhance its signal capability to try to identify how it can use pre-existing registries? Improvement is needed on Yellow Cards with regard to medical devices [for which the MHRA is also the British regulator]. How to enhance this? It's a work in progress.

1hr 40’ – General comments about Cumberlege Review – patient safety.

1hr 44:30 – Discussion of how the public can contact the Patient Safety Commissioner and that the MHRA has contacted her, requesting to connect with her.

1hr 46’ – Mercy Jaysingham, Non-Executive Director, Patient Safety Committee – Are patients aware that their GPs’ medical records are made accessible to the MHRA through the Clinical Practice Research Datalink (CPRD) database?

1hr 52’ – Mandy Calvert – Performance, competitive salaries, and identifying the risks of ‘transformation’

1hr 57’ – June Raine appears hesitant and unsure when replying to a question

2hr 2’ – From this point to the end of the meeting, questions from the public

Last 20 minutes – includes two questions on Yellow Cards. One member of the public, calling in live by video link, talks about monkeypox. There is also a question on the frequency of MHRA board meetings.