This video, currently exclusive to the UK Column, was recorded by participants at the MHRA's September 2022 Board Meeting. The following time-stamped summaries are courtesy of nursing correspondent Debi Evans.
The MHRA's full governance structure can be found here here.
Timestamps are approximate and only a guide, and the length of the items described may vary. Therefore, only the start time is shown.
Starts at 9 minutes – Introduction by Stephen Lightfoot, MHRA Board Meeting Chair – Click here for details on conflicts of interest and attendees and number of people watching remotely.
9:00 – CEO Report: Dame June Lane talks about the agency's priorities from her perspective
14:00 – June Lane – Working
15:15 – June Lane – Public Trust – How are we connected? – Are we “getting there”?
17:20 – Chief Safety Officer Alison Cave says: yellow cardNHS Digital and Signals (sign of problem)
18:10 – delivery plan – What is MHRA’s “transformation”? How long does it take? – Stephen Lightfoot
23:00 – Interim Chief Financial Officer, John Taylor
26:20 – Non-executive director Mandy Calvert asks about the financials for the fourth quarter of this year. John Taylor answers, but seems unsure if he can talk.
27:50–33:00 – Enhanced Clinical Trials Funding Issues – Discussion about lack of funding
40:30 – Chief Quality and Access Officer Dr. Laura Squire speaks: active recording Ensuring that all MHRA staff know what they are doing and can 'track' their performance.
42:00 – Staff at the National Institute of Biological Standards and Control (NIBSC) laboratory in South Mims. How do they prioritize monkeypox?
45:15 – Operational performance MHRA – How we measure and manage performance
49:40 – People and MHRA – Staff vacancies
50:20 – CEO June Lane talks about vacancies and MHRA utilization headhunter to find the right candidate
52:10 – Alison Cave talks about vaccine side effects, signals and the hard work of MHRA staff
58:50 – Mandy Calvert: The MHRA is currently 200 staff short and struggling to recruit. There were 74 people who voluntarily resigned. She asks, “Don’t people like working here?” What prevents people from working for the MHRA?
1 hour passed – June Lane responds: Many staff members have postponed their retirement to stay with the company. In the short term we are focusing on the issue of career possibilities.
1 hour 1 minute – Alison Cave on safety and surveillanceAlthough the quality of staff has improved, with the MHRA redeploying junior staff to more senior roles, filling gaps at the bottom is proving difficult.
1 hour 3:50 – Michael Whitehouse – Is the MHRA calling on MPs to weigh in and raise awareness about the agency? What are they hearing from their constituents? Members of Congress make interesting agents. Should the MHRA contact them?
1 hour 4:45 – June Lane responds: It's good to hear from your legislators.
1 hour 6:20~ science, research and innovation
1 hour 6:30 – Dr. Paul Goldsmith: Clinical trials and safety concerns – Coverage Report
1 hour 7:10 – Dr. Mark Bailey: The future of NIBSC clinical trials – No one seems able to answer your questions. Very awkward. No one takes responsibility.
1 hour 9:10 – Stephen Lightfoot – it is work in progress
1 hour 9:40 – Katherine Glover, Deputy Director of Prescription – Ministry of Health: How to ensure every body is functioning effectively. Head of Strategic Research. Is there anything the MHRA can do to help?
1 hour 14 minutes – Dr Laura Squire – The work the MHRA is doing to improve performance. License Approval. people, processes and technology.
people – Critical resource gap: drug evaluators. Pay is an issue because staff need training. Struggling to recruit non-clinical evaluators. How can the MHRA address immediate and long-term issues?
process – Consistency; MHRA continues its dialogue on consistency. Next workshop: Defining high quality assessment. what does it look like?
technology – The discussion has begun. Assign someone who can deliver to the post.
1 hour 19 minutes – Dr. Laura Squire – reassures committee that new medicines are on the way as everyone is so focused on COVID-19
1 hour 20 minutes – Dr. Laura Squire – Introducing critical finding questions: Is there a problem? But does it matter?
1 hour 26:10 – Dr. Alison Cave safety report – Monitoring, patient involvement. Patients play an essential role in our work. Transforming the MHRA, built with patients at the center of everything we do. What patients see, a new code of practice conflict of interestexperts remain impartial.
patient involvement. Patient participation strategy – reflects patient input and patient input. New benefits of the yellow card system. Additional information from the patient. Yellow card newsfeed.
Evidence generation ability – Pregnancy notification – teratogenic (Treatment method that produces mutants). Future medical device system. Committed to working collaboratively with patients and patient safety committee members.
1 hour 29 minutes 50 seconds – Dr. Paul Goldsmith – Are your plans a reality or just a wish?
1 hour 30 minutes – Dr. Alison Cave: Medical Devices and Safety. Track patient progress using the registry and unique identification numbers through the registry. We work with NHS Digital. It won't happen right away, but there will be connections between different groups. I look forward to the future, It takes time.
1 hour 32:30 – Catherine Glover – Uncertain impact of mergers, NHS digitization on patient safety issues – Governance overhaul
1 hour 33 minutes – Professor Graham Cooke – How do you detect the next “mesh”? I’m not sure how the MHRA will do this.
1 hour 33 minutes 45 seconds – Dr. Alison Cave – New laws, devices, and surveillance – Unique device identifiers. Track patient progress. registry.
1 hour 44 minutes – Stephen Lightfoot talks about cabinet decisions. S stands for safety and says it should be included in the Health Secretary's ABCD plan for the NHS.
Safety Connect: Improves capture and interrogation when receiving signals.
patient involvement and listening To the patient. What steps does the MHRA need to take to strengthen its capabilities? signal Is there a feature that identifies how existing registries can be used? Needs improvement for yellow cards medical equipment (The MHRA is also the UK regulator). How can we strengthen this? it is work in progress.
1 hour 40 minutes – General Comments on Coverage Review – Patient Safety.
1 hour 44:30 – Discussion on how the public can get in touch patient safety committee The MHRA then contacted her and asked her to get in touch.
1 hour 46 minutes – Ms. Mercy Jaysingham, Non-Executive Director, Patient Safety Committee – Is the patient aware that his/her GP’s medical records are:? You can now access the MHRA through Clinical practice research data link (CPRD) database?
1 hour 52 minutes – Mandy Calvert – Performance, competitive pay, and identifying the risks of “transformation”
1 hour 57 minutes – June Lane hesitates and seems unsure when answering questions.
2 hours 2 minutes – from this point until the end of the meeting. Questions from the public
last 20 minutes – Includes Two questions about yellow cards. One member of the public, who called in live via video link, talks about monkeypox. There are also questions about the frequency of MHRA board meetings.
