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Select committee: Health and Social Care Committee

IMMDS Review follow up one-off session

Closed Opened 1 Sep 2022 Closed 6 Feb 2023 4 recommendations 5 conclusions

Health and Social Care Committee Inquiry on parliament.uk ↗

Inquiry scope (the committee's words)
MPs will examine government progress on recommendations made by the Independent Medicines and Medical Devices Safety (IMMDS) Review in a report, ‘First Do No Harm’, published in 2020. An update by Ministers on progress to implement the government’s response was due this summer. A Minister from the Department of Health and Social Care has been invited to appear before the Committee. The IMMDS Review’s report called for better communication to inform women of the risks of sodium valproate in pregnancy. Despite an NHS ‘valproate pregnancy prevention programme’, 247 women since April 2018 were found to have been prescribed the drug in a month in which they were pregnant, 25 as recently as April to September last year. The review also called for better care and support for women who experienced adverse effects from surgical mesh implants, including specialist treatment centres.

Where it stands

The inquiry is closed, opened 1 September 2022.

The committee has published 1 report, most recently Sixth Report - Follow-up on the IMMDS report and the Government’s response on 20 January 2023.

The government's response

Published 24 April 2023. The deadline was 20 March 2023.

Summary written by Accountability Index from the government's response. It is not the government's own words.

The Government welcomes the Committee's report and sets out progress on its IMMDS commitments, but says it does "not believe it is necessary to create a new agency for redress".

  • On records of devices, NHS England has begun developing a new 'Medical Device Outcome Registry', with the platform set for launch in April 2023 and work with Devolved Governments on a UK-wide approach "where appropriate to do so".
  • On the register of clinicians' interests, the Government "expect[s] the implementation phase to begin in England in April 2023", with a lead-in of approximately 18 months before the CQC begins monitoring publications.
  • On industry payments, it aims to launch a six-week public consultation in Spring 2023 on the potential to introduce regulations mandating reporting; any regulations would follow that consultation.
  • On redress, a specification has been shared with the Patient Safety Commissioner; the work is "expected to take around four months", after which the Department "will need to consider its findings".

Read the government's response ↗ Report an error

Recommendations and conclusions

All 9 recommendations and conclusions

Reports

All reports

Evidence

  • 2 oral evidence sessionsLatest 13 December 2022
  • 12 witnesses
All evidence

Recent activity

Recommendations and conclusions 9 shown

1: Ensure urgent and full implementation of IMMDS review recommendations 6 and 7 on patient records

Recommendation · Sixth Report - Follow-up on the IMMDS report and the Government’s response · Addressed to Department of Health and Social Care

Recommended (the committee's words)
Without records of which patient has undergone which procedure, or been prescribed which drug, the health system will continue to, in the words of the IMMDS review team, “fly blind”. We recommend that the Government urgently ensures that the accepted recommendations 6 and 7 of the IMMDS review are fully implemented.

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2: Retrospective mesh implant audit insufficient for capturing all adverse patient experiences

Conclusion · Sixth Report - Follow-up on the IMMDS report and the Government’s response · Addressed to Department of Health and Social Care

Concluded (the committee's words)
Although the retrospective audit of mesh implants is an encouraging first step, it will be unlikely to reflect and take into account all of the adverse effects women have experienced due to the nature of data used in the audit. We therefore recommend that the Government consider an alternative strategy for how to pro-actively contact those who have had the procedure about their post-operative experiences and possible side effects.

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3: Set up register of clinicians' interests swiftly after pilot conclusion to prevent delay

Recommendation · Sixth Report - Follow-up on the IMMDS report and the Government’s response · Addressed to Department of Health and Social Care

Recommended (the committee's words)
We were encouraged to hear that the Government is going ahead with pilots of a register of clinicians’ interests, but we are disappointed by the speed at which the Government is acting on this recommendation. We urge the Government to make the arrangements necessary to ensure the register can be set up swiftly, subject to the pilot phase concluding, to prevent further delay.

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4: Bring in secondary legislation swiftly for register of industry payments to clinicians

Recommendation · Sixth Report - Follow-up on the IMMDS report and the Government’s response · Addressed to Department of Health and Social Care

Recommended (the committee's words)
Although the Government has also given itself the powers to set up a register of industry payments to clinicians, no decision has been made yet about how to implement it, and officials were not able to share a plan of when the register would be active. A register would provide transparency and reassurance, and we urge the Government to move at pace to bring in the necessary secondary legislation to set this up.

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5: Patient Safety Commissioner's role impeded by lack of clear responsibilities and resources

Conclusion · Sixth Report - Follow-up on the IMMDS report and the Government’s response · Addressed to Department of Health and Social Care

Concluded (the committee's words)
Although the vision for what the role of Patient Safety Commissioner will achieve is publicised by the Department, no statement of specific assignments or areas of responsibility, have been published yet. As we set out in our report on the pre- appointment hearing with Dr Hughes, metrics for success and clearly defined responsibilities are needed. Only when these are clearly established can resources be adequately assigned. The risk if this is not done is that the maximum benefit to patient safety will not be fully realised. We therefore urge the Secretary of State to ensure that the Patient Safety Commissioner’s ability to carry out her important role, as her duties and responsibilities become more clearly defined, is not impeded by a lack of resource for and within her office.

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6: Patient engagement with lived experience stakeholders remains inadequate for care schemes

Conclusion · Sixth Report - Follow-up on the IMMDS report and the Government’s response · Addressed to Department of Health and Social Care

Concluded (the committee's words)
We are concerned that although the letter from the Department seems to outline various interactions and consultations with stakeholders, and mentions Sling the Mesh by name, this is not the experience of some patients. Patient input is vital in setting up care schemes such as this one. We therefore urge the Department to reflect on the experience of some of the stakeholders with lived experience in this instance, and to consider how to improve engagement with them in the future.

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7: New clinical negligence pathways offer no substantial improvement for seeking redress

Conclusion · Sixth Report - Follow-up on the IMMDS report and the Government’s response · Addressed to Department of Health and Social Care

Concluded (the committee's words)
It is positive that the Government has improved its communication and information online around how to bring claims of clinical negligence through the 20 Follow-up on the IMMDS report and the Government’s response new “pathways”. However, these pathways do not represent a substantial change or benefit to stakeholders who have repeatedly expressed their frustration regarding seeking redress.

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8: Require Secretary of State to detail resources for Patient Safety Commissioner's redress review

Recommendation · Sixth Report - Follow-up on the IMMDS report and the Government’s response · Addressed to Department of Health and Social Care

Recommended (the committee's words)
The focus of Patient Safety Commissioner and small team, and must remain, patient safety and harm prevention. If the additional responsibility of reviewing redress is placed on the Patient Safety Commissioner, the Secretary of State must ensure that the Commissioner and her office has access to proper independent expert advice and support. We urge the Secretary of State to make a statement detailing the Patient Safety Commissioner’s review of redress schemes for the medical interventions dealt with by the IMMDS review, and what additional resources will be made available to her to undertake it.

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9: Committee seeks Minister's statement on redress review and Redress Agency timeline

Conclusion · Sixth Report - Follow-up on the IMMDS report and the Government’s response · Addressed to Department of Health and Social Care

Concluded (the committee's words)
We would welcome a statement from the Minister on the review of redress and a possible Redress Agency, with more details on what such a review would include and seek to achieve, and timeline for completion.

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Reports

1 report

Oral evidence sessions

2 sessions

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Date Session and witnesses Source
13 Dec 2022
Oral evidence session
Baroness Julia Cumberlege · Independent Medicines and Medical Devices Safety Review, Celia Ingham-Clark · Department of Health and Social Care, Dame June Raine · Medicines and Healthcare products Regulatory Agency (MHRA), Dr Aidan Fowler · Department of Health and Social Care, Emma Murphy · Independent Foetal Anti-Convulsant Trust (In-FACT), Janet Williams · Independent Foetal Anti-Convulsant Trust (In-FACT), Kath Sansom · Sling the Mesh Campaign, Maria Caulfield · Department of Health and Social Care, Professor Sir Cyril Chantler · Independent Medicines and Medical Devices Safety Review, Simon Whale · Independent Medicines and Medical Devices Safety Review, William Vineall · Department of Health and Social Care 		View ↗
13 Sep 2022
Oral evidence session
Baroness Julia Cumberlege · Independent Medicines and Medical Devices Safety Review, Celia Ingham-Clark · Department of Health and Social Care, Dame June Raine · Medicines and Healthcare products Regulatory Agency (MHRA), Dr Aidan Fowler · Department of Health and Social Care, Emma Murphy · Independent Foetal Anti-Convulsant Trust (In-FACT), Janet Williams · Independent Foetal Anti-Convulsant Trust (In-FACT), Kath Sansom · Sling the Mesh Campaign, Marie Lyon · Association for Children Damaged by Hormone Pregnancy Tests, Professor Sir Cyril Chantler · Independent Medicines and Medical Devices Safety Review, Simon Whale · Independent Medicines and Medical Devices Safety Review, William Vineall · Department of Health and Social Care 		View ↗

Who gave evidence

12 witnesses

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WitnessOrganisationSessions
Baroness Julia Cumberlege · Chair Independent Medicines and Medical Devices Safety Review 2
Celia Ingham-Clark · Medical Director for Professional Leadership and Medical Workforce Department of Health and Social Care 2
Dame June Raine · Chief Executive Medicines and Healthcare products Regulatory Agency (MHRA) 2
Dr Aidan Fowler · National Director of Patient Safety in England Department of Health and Social Care 2
Emma Murphy · Founder Independent Foetal Anti-Convulsant Trust (In-FACT) 2
Janet Williams · Founder Independent Foetal Anti-Convulsant Trust (In-FACT) 2
Kath Sansom · Campaigner Sling the Mesh Campaign 2
Professor Sir Cyril Chantler · Deputy Chair Independent Medicines and Medical Devices Safety Review 2
Simon Whale · Review Member and Communications Lead Independent Medicines and Medical Devices Safety Review 2
William Vineall · Director of NHS Quality, Safety and Investigations Department of Health and Social Care 2
Maria Caulfield · Parliamentary Under-Secretary of State Department of Health and Social Care 1
Marie Lyon · Chair Association for Children Damaged by Hormone Pregnancy Tests 1

Correspondence

5 letters

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PublishedDirectionLetter
11 Jan 2023 To committee Letter from Minister Maria Caulfield (IMMDS review) 19.12.22
20 Dec 2022 Not recorded Correspondence from Sling the Mesh on the IMMDS Review 16.12.22
20 Dec 2022 Not recorded Correspondence from In-FACT on the IMMDS Review 14.12.22
20 Dec 2022 Not recorded Correspondence from FDNH review team on the IMMDS Review 15.12.22
20 Dec 2022 Not recorded Correspondence from Celia Ingham-Clark on the IMMDS Review 16.12.22