Patient safety commissioner pushes government on valproate redress almost two years after report

Henrietta Hughes, the patient safety commissioner, has urged the UK government to respond to her recommendations on redress for patients and families affected by the anti-epileptic sodium valproate, saying those affected have “immediate unmet needs”.

‘The Hughes report‘, published in February 2024, called on the government to set up a two-stage redress scheme, including a possible £100,000 for each patient harmed as a result of valproate use, followed by a main scheme payout, based on the individual needs of each patient.

Hughes’ exclusive statement to The Pharmaceutical Journal follows a letter written by campaigners from the Independent Fetal Anti-Convulsant Trust and Fetal Anti-Convulsant Syndrome Association to the government calling for compensation and clarity.

The letter, addressed to Keir Starmer, UK prime minister, and Rachel Reeves, chancellor of the exchequer, dated 9 September 2025 and seen by The Pharmaceutical Journal, was written by Janet Williams and Emma Murphy, both of whom are mothers of children with foetal valproate syndrome.

It said that children affected by valproate “continue to live with devastating neurodevelopmental, mental and physical disabilities, while their families struggle with the ongoing emotional, practical and financial burden”.

“The continued silence from government is not only prolonging uncertainty but is also raising anxiety among families who feel they have been failed yet again,” they added.

“Families affected by sodium valproate exposure do not have the luxury of time. The children are growing, their care needs are increasing and their families are at breaking point. Every further delay not only worsens the hardship faced but also risks undermining trust in government commitments to patient safety and justice.”

In a statement made to The Pharmaceutical Journal, Hughes echoed Williams’ and Murphy’s concerns.

“While the government reviews my recommendations for financial and non-financial redress, the needs of patients and families are not put on hold. These patients, many with physical and learning disabilities, have immediate unmet needs and I urge the government to provide a full response to my recommendations,” she said.

Unborn babies exposed to sodium valproate are at risk of developing foetal valproate spectrum disorder — the collective name for the variety of disorders and development issues some children experience after being exposed to the drug in the womb​.

These include spina bifida, autism and malformations of the brain, heart and kidneys, and — in the most severe cases — are linked with fatalities.

In their letter, Williams and Murphy urged the government to:

• Provide a clear timetable for the government’s formal response to the Hughes report;
• Confirm whether interim payments will be made available; and
• Commit to establishing a comprehensive redress scheme without further delay.

The campaigners also wrote to cabinet secretary Sir Chris Wormald on 19 September 2025, asking whether a formal commitment or timeline for action would be announced following the parliamentary recess for party conferences.

In the letter they urged the cabinet secretary “to ensure that a meaningful and timely response is issued without further delay”.

The Hughes report also highlighted the need for other forms of redress for those affected by valproate, including a dedicated housing grant, alongside improved access to education, benefits and support, as well as calling for an independent redress agency to be established.

In July 2020, the ‘First do no harm: report of the independent medicines and medical devices safety review‘ reported that “hundreds” of babies each year were estimated to be exposed to valproate in utero and “too many women still do not have [the] information” needed to make an informed choice about the drug.

In September 2025, NHS England data revealed that the number of women prescribed sodium valproate in pregnancy had fallen to its lowest level yet.

According to the NHS Medicines and Pregnancy Dashboard, five women were prescribed valproate while pregnant between October 2024 and March 2025, although none of these women started valproate while pregnant.

The government was approached for comment.