Sam Friedrich
Henrietta Hughes, the patient safety commissioner for England, has said that the government has produced neither a redress scheme for patients harmed by sodium valproate nor a timeline for a ‘substantive response’ to recommendations she made on the issue.
In the patient safety commissioner’s ‘Annual report for 2025-26‘, published on 13 July 2026, Hughes described what she called a “stark lack of government response” to recommendations made in her February 2024 ‘Hughes report’ to address harms caused by sodium valproate and pelvic mesh.
Hughes’ recommendations in her 2024 report included a call for the government to set up a two-stage redress scheme, with a possible £100,000 payment for each patient harmed as a result of valproate use, which would be followed by a main scheme payout, based on the individual needs of each patient.
In her 2025/2026 annual report, Hughes said: “At the time of writing, the government is yet to announce a redress scheme or a timeline for providing a substantive response to the recommendations made in the Hughes report.
“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.
“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 is the collective name for the variety of disorders and development issues some children experience after being exposed to the drug in the womb.
Associated disorders and development issues include spina bifida, autism, malformations of the brain, heart and kidneys. In the most severe cases of valproate spectrum disorder, these conditions are linked with fatalities.
Hughes said that up to 20,000 children in England were exposed to valproate between 1973 and 2017, while many are unable to live independently, with parents and carers having to give up work to look after them.
In October 2025, The Pharmaceutical Journal exclusively reported that campaigners from the Independent Fetal Anti-Convulsant Trust (INFACT) and Fetal Anti-Convulsant Syndrome Association had written to prime minister Keir Starmer, calling for compensation and clarity for those affected by valproate use.
Then, in March 2026, with no progress on redress, Hughes wrote to the prime minister 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”.
In a statement published alongside the annual report, Hughes said: “The conversations I have had with affected families make clear that this is not simply about compensation. It is about acknowledgement. It is about accountability. It is about recognising the profound impact these harms have had on people’s lives and rebuilding trust in a healthcare system that failed them.”
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.
“With the appointment of a new prime minister, we believe this presents an important opportunity to move this issue forward. We have already held a number of constructive meetings with Andy Burnham regarding valproate and the need for a fair redress scheme, and we hope he will continue to build on the support he has previously shown.
“We are aware that progress on redress has been delayed, with HM Treasury understood to be a key part of the decision-making process. In light of the new government and cabinet, we sincerely hope this issue will now be reconsidered with the sympathy, urgency and understanding it deserves.”
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.”
