The Hughes Report: Options for redress for those harmed by valproate and pelvic mesh (Patient Safety Commissioner for England, 7 February 2024)

Summary

In late 2023, the Minister for Mental Health and Women’s Health Strategy, Maria Caulfield MP, asked the Patient Safety Commissioner for England to explore redress options for those who have been harmed by pelvic mesh and sodium valproate. This report sets out the outcome of this project and is designed to help the government understand the options available for providing redress to those patients harmed by pelvic mesh and valproate.

Content

The Independent Medicines and Medical Devices Safety Review, published in July 2020, highlighted the scale of avoidable harm related to three medical interventions: hormone pregnancy tests, sodium valproate and pelvic mesh implants. One of the Review’s key recommendations was that separate redress schemes should be established for patients adversely affected by these interventions.

This report by the Patient Safety Commissioner for England focuses on two of these interventions, sodium valproate and pelvic mesh. It recommends the government creates a two-stage financial redress scheme – an interim scheme to enable the identification of all those harmed ensuring patients receive financial redress quickly – and a main scheme.

The report makes ten recommendations:

1. The government has a responsibility to create an ex-gratia redress scheme providing financial and non-financial redress for those harmed by valproate and pelvic mesh. This scheme should be based on the principles of restorative practice and be co-designed with harmed patients.
2. Redress should provide all those harmed by pelvic mesh or valproate with access to non-financial redress. To deliver this, the government should work with other government departments, the healthcare system and local authorities to measurably improve harmed patients access to, and experience of, public services.
3. The government should create a two-stage financial redress scheme comprising an Interim Scheme and a Main Scheme.
4. The Interim Scheme should award directly harmed patients a fixed sum by way of financial redress. These payments should start during 2025.
5. The Interim Scheme should be followed by a Main Scheme. This would offer more bespoke financial support to directly harmed patients based on their individual circumstances and – subject to further consultation on definitions – those indirectly harmed.
6. Patients who received relevant treatment through either the NHS or independent sector should be eligible for the Interim Scheme and Main Scheme.
7. Patients should find the application process for both the Interim Scheme and the Main Scheme straightforward, accessible and non-adversarial. To support this, a presumption of truth should be embedded within the scheme, which would apply when assessing the evidence provided by patients to meet the eligibility criteria.
8. Both the Interim Scheme and the Main Scheme should be administered by an independent body which commands the confidence of patients.
9. Both the Interim Scheme and the Main Scheme should effectively signpost harmed patients to services which can provide them with free emotional support.
10. The government must ensure that the launch of the Interim Scheme and the Main Scheme is accompanied by an awareness raising campaign to ensure that all potentially eligible patients are made aware of it. The government needs to make specific efforts to ensure those patients from disadvantaged and marginalised groups are reached.

Related reading

• First Do No Harm. The report of the Independent Medicines and Medical Devices Safety Review (8 July 2020)
• Redress, research and regulatory reform are still needed: An overview of patient safety issues related to surgical mesh (Patient Safety Learning, 1 May 2023)
• The difficulty of medical negligence cases and why financial redress from the Government is so important for mesh victims (Kath Sansom, 17 January 2023)
• When will the Government take responsibility and meet the needs of all mesh patients? A blog by Paula Goss (17 October 2023)