Henrietta Hughes, the patient safety commissioner for England, has expressed concern over the government’s lack of response to recommendations on sodium valproate redress. In her Annual report for 2025-26, published on July 13, 2026, Hughes described a stark lack of government response to her February 2024 report on addressing harms caused by sodium valproate and pelvic mesh.
Hughes’ 2024 report recommended a two-stage redress scheme, with a possible £100,000 payment for each patient harmed as a result of valproate use, followed by a main scheme payout based on individual needs. However, the government has yet to announce a redress scheme or a timeline for responding to the recommendations.
Hughes stated that “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.” She added: “There is an urgent moral imperative to address past harm. Delivering redress is fundamental to keeping people safe — without accountability, failures persist, lessons go unlearned and patients remain at risk.”
Foetuses exposed to sodium valproate are at risk of developing foetal valproate spectrum disorder, which can lead to disorders and development issues such as spina bifida, autism, and malformations of the brain, heart, and kidneys. Up to 20,000 children in England were exposed to valproate between 1973 and 2017, with many unable to live independently.
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Campaigners’ efforts
In October 2025, campaigners from the Independent Fetal Anti-Convulsant Trust (INFACT) and Fetal Anti-Convulsant Syndrome Association wrote to Prime Minister Keir Starmer, calling for compensation and clarity for those affected by valproate use. Hughes also wrote to the prime minister in March 2026, saying that “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.”
A spokesperson for INFACT told The Pharmaceutical Journal: “We are extremely grateful to the patient safety commissioner for the dedication, persistence and time she has devoted to this issue. Her continued efforts, including using all the powers available to her to press for a response to the ‘Hughes report’ recommendations, demonstrate her unwavering commitment to those affected by valproate and other avoidable harms.”
A spokesperson for the Department of Health and Social Care said: “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.”