House of Commons Debate - Independent Medicines and Medical Devices Safety Review (8 July 2021)

Summary

This is the transcript of a backbench debate in the House of Commons regarding the implementation of the recommendations of First Do No Harm report, published by the Independent Medicines and Medical Devices Safety Review on the 8 July 2020, chaired by Baroness Cumberlege (also known as the Cumberlege Review).

Content

The debate centred on a motion put forward by Emma Hardy, MP for Kingston upon Hull West and Hessle, which read as follows:

That this House notes the publication of the Independent Medicines and Medical Devices Safety Review, First Do No Harm; further notes the Government’s failure to respond to the recommendations of that review in full; notes the significant discrepancy between the incidence of complication following mesh surgery in the Hospital Episode Statistics and the British Society of Urogynaecology databases, as highlighted in the Royal College of Obstetricians and Gynaecologists’ Project Report, entitled Hospital Episode Statistics as a Source of Information on Safety and Quality in Gynaecology to Support Revalidation; notes that the Government’s plan to publish a retrospective audit to investigate the links between patient-level data to explore outcomes has not been fulfilled; notes that the moratorium on mesh implant procedures should not be lifted until that audit has been undertaken and the true scale of suffering established; notes Ministers’ failure to acknowledge recommendations relating to victims of Primodos; and calls on the Government to fully implement the recommendations for victims of mesh, sodium valproate and Primodos without further delay.

During the debate there were contributions from a range of parliamentarians reflecting on the findings of the First Do No Harm report, the implementation of its recommendations and sharing experiences of their constituents in regard to the three medical interventions considered: Hormone pregnancy tests (HTPs), Sodium valproate and Pelvic mesh implants.

Key issues raised in the debate included:

• The Government’s decision to reject the second recommendation of the report, to establish a new independent Redress Agency for those harmed by medicines and medical devices.
• Discussions about the specialist centres and for mesh removal, including concerns about whether any data collection is taking place on patient outcomes after mesh removal and the involvement of clinicians who have initially implanted mesh in patients.
• Calls for the Government implement the report’s fourth recommendation to set up separate support schemes for patients effected by each intervention: HPTs, valproate and pelvic mesh. It was noted by several MPs that there was a precedent for this recently set by the decision to put in place lifetime financial aid for UK thalidomide victims.
• Concerns about the report reflecting a wider theme of sexist attitudes in healthcare and the dismissal of women raising serious patient safety concerns.
• The need for more action by the Government regarding the risks associated with Sodium valproate, ensuring that in addition to proving information to women taking the medication that clinicians are well informed of the risks when they are prescribing and dealing with cases.
• Support for the introduction of a UK-style Physician Payments Sunshine Act, to require the mandatory reporting of all payments made to doctors, teaching hospitals, research institutions and charities.
• Discussions around the proposed Patient Safety Commissioner for England, concerning the timetable for their appointment and the degree of independence the role-holder will have from the Department of Health and Social Care.

Follow the link here or at the bottom of the page for the full transcript.

Further reading

• Analysing the Cumberlege Review: Who should join the dots for patient safety? (Patient Safety Learning)
• Consultation: The appointment and operation of the Patient Safety Commissioner for England (Department of Health and Social Care)
• Findings of the Cumberlege Review: informed consent (Patient Safety Learning)
• Findings of the Cumberlege Review: patient complaints (Patient Safety Learning)
• First Do No Harm report (Independent Medicines and Medical Devices Safety Review)
• No such thing as a free lunch – why recording conflicts of interests must be mandatory (Kath Sansom)
• Regulatory flaws: Women were catastrophically failed in the mesh, Primodos and Sodium Valproate tragedies (Kath Sansom)
• Sodium Valproate: The Fetal Valproate Syndrome Tragedy (Sharon Hartles)