Mental Fitness

Government criticized for inaction on valproate harm redress

Government criticized for inaction on valproate harm redress

Henrietta Hughes, England’s patient safety commissioner, criticized the government’s lack of action on sodium valproate harm. In her 2025-26 annual report, published on 13 July 2026, Hughes highlighted the absence of a redress scheme for affected patients and a timeline for addressing her 2024 recommendations, describing it as a “stark lack of government response.” This report follows her February 2024 ‘Hughes report,’ which detailed the need for urgent action on harms caused by sodium valproate and pelvic mesh.

Hughes’ 2024 report proposed a two-stage redress scheme, including a potential ÂŁ100,000 payment per patient harmed by valproate, followed by a main scheme payout based on individual needs. However, as of July 2026, the government has not announced a scheme or response timeline, despite Hughes’ emphasis on the moral imperative to address past harm. She stated, “Clarity of purpose and urgency of action are essential when it comes to addressing risks to patient safety and past harm caused by medicines and medical devices.”

The impact of sodium valproate exposure

Sodium valproate exposure in the womb can cause fetal valproate spectrum disorder, leading to disorders like spina bifida, autism, and malformations of vital organs such as the brain, heart, and kidneys. In severe cases, these conditions are linked to fatalities. Up to 20,000 children in England were exposed between 1973 and 2017, with many unable to live independently. Parents and carers often have to give up work to provide lifelong care, showing the profound societal and personal impact of this issue.

Campaigners push for compensation and clarity

In October 2025, campaigners from the Independent Fetal Anti-Convulsant Trust (INFACT) and Fetal Anti-Convulsant Syndrome Association wrote to Prime Minister Keir Starmer, demanding compensation and clarity for valproate-affected individuals. The Pharmaceutical Journal exclusively reported this development, highlighting the growing urgency of the issue.

Hughes echoed this call in March 2026, urging decisive leadership from the government. In her letter to the Prime Minister, she stated, “The continued absence of a clear timetable for financial compensation compounds the harm already suffered. As the authority to deliver financial compensation rests with HM Treasury and Number 10, decisive leadership from the centre of government is now essential.”

Government response and next steps

The Department of Health and Social Care acknowledged Hughes’ efforts, stating they are carefully considering the redress recommendations. However, they did not provide a specific timeline for their response, leaving affected families and campaigners in a state of uncertainty. A spokesperson commented, “We welcome the patient safety commissioner’s continued focus on amplifying patients’ voices and improving safety across the health system. We are carefully considering the recommendations on redress and will respond in due course.”

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