A year on from The Hughes Report: Urgent action needed on redress (Patient Safety Learning, 7 February 2025)

Summary

A year ago today the Patient Safety Commissioner for England published The Hughes Report, which set out options for redress for those who have been harmed by valproate and pelvic mesh. In this blog, Patient Safety Learning reflects on the failure to act on its recommendations 12 months on.

Content

The Independent Medicines and Medical Devices Safety (IMMDS) Review published its report, First Do No Harm, on 8 July 2020. It examined how the healthcare system in England responds to reports about harmful side effects from medicines and medical devices, focusing on three medical interventions:

• hormone pregnancy tests (HPTs)
• sodium valproate
• pelvic mesh.

The report outlined how these interventions had resulted in a truly shocking degree of avoidable harm to patients over a period of decades. It made nine recommendations as part of this, two of which specifically concerned redress options for patients:

“Recommendation 3: A new independent Redress Agency for those harmed by medicines and medical devices should be created based on models operating effectively in other countries. The Redress Agency will administer decisions using a non-adversarial process with determinations based on avoidable harm looking at systemic failings, rather than blaming individuals.

Recommendation 4: Separate schemes should be set up for each intervention—HPTs, valproate and pelvic mesh—to meet the cost of providing additional care and support to those who have experienced avoidable harm and are eligible to claim.”[1]

Though the Government initially rejected both these recommendations, patients and family members harmed by these medical interventions continued to tirelessly campaign for appropriate redress.[2] Responding to this, in early 2023 the then Minister for Mental Health and the Women’s Health Strategy, Maria Caulfield MP, signalled that the Government would be willing to look again at the issue of redress. She commissioned the Patient Safety Commissioner for England to explore redress options for those who have been harmed by two of the interventions covered by the IMMDS Review: sodium valproate and pelvic mesh.

The Hughes Report

Published on the 7 February 2024, the Patient Safety Commissioner set out options for redress for those harmed by pelvic mesh and sodium valproate in The Hughes Report.[3] At the core of its recommendations is a proposal to create a two-stage financial redress scheme. Responding at the time, we set out our support for these recommendations.[4]

Patient Safety Learning believes, like many individual patients and patient groups, that there must be redress options for patients harmed by the interventions covered by the IMMDS Review. There is considerable evidence that for many patients the clinical negligence route is simply not viable and, in the absence of any system of redress, this leaves them with no assistance to help meet the cost of any additional care and support they may need.

We also believe that this should extend to those affected by hormone pregnancy tests, who fell outside of the scope of The Hughes Report’s recommendations. Excluding patients and family members affected by hormone pregnancy tests from redress is not acceptable or in keeping with the spirit of the IMMDS Review’s recommendations.

Commenting on this, our Chief Executive Helen Hughes said:

“It is now over four and a half years on from the redress schemes first being recommended by the IMMDS Review. We think that it is unacceptable that there has been no response to The Hughes Report, over a year after its publication. Patients and their families are suffering unacceptably without redress schemes.

The Government must respond to this report promptly and take steps to deliver redress for all those affected by pelvic mesh, sodium valproate and hormone pregnancy tests as a matter of urgency.”

References

1. The IMMDS Review. First Do No Harm, 8 July 2020.
2. Department of Health and Social Care. Government response to the report of the Independent Medicines and Medical Devices Safety Review, 21 July 2021.
3. Patient Safety Commissioner for England. The Hughes Report: options for redress for those harmed by valproate and pelvic mesh, 7 February 2024.
4. Patient Safety Learning. Reflections on The Hughes Report: Pelvic mesh, sodium valproate, hormone pregnancy tests and options for redress, 20 February 2024.