Health ministers in Scotland, Wales and Northern Ireland have jointly asked the UK Government to set out its response to recommendations for redress for people harmed by sodium valproate and their families.
The ministers wrote to Dame Diana Johnson, the UK minister responsible for public health and patient safety, saying that the lack of a full response to the Hughes report was adding to uncertainty for affected families. They asked her to explain the Government’s proposed approach and what would happen next.
The letter was signed by Scotland’s public health minister, Maree Todd; the Welsh health and care minister, Mabon ap Gwynfor; and Northern Ireland’s health minister, Robbie Butler. They said they were ready to consider proposals from the UK Government.
The request is not an announcement of a compensation scheme. In a Commons debate on 29 October, Johnson said a decision had not yet been taken to provide financial redress. She said the Government was assessing the available options and intended to pursue discussions with greater urgency.
What the report recommended
Dr Henrietta Hughes, the Patient Safety Commissioner for England, published her report in February 2024. It considered redress for people harmed by valproate and by pelvic mesh, a medical device used to treat some forms of incontinence and pelvic organ prolapse.
The report proposed financial and non-financial support, with patients involved in designing a scheme. It recommended a two-stage financial scheme: an interim stage offering a fixed payment to people directly harmed, followed by a main scheme providing support based on individual circumstances.
The proposed main scheme could also cover people indirectly harmed, subject to further consultation on definitions. Hughes recommended that an independent body administer the schemes and that the application process be accessible and non-adversarial.
She recommended that interim payments begin during 2025. That was a recommendation, not a deadline adopted by the Government. Decisions about whether to establish a scheme and who would be eligible remain for ministers; the report itself does not create an entitlement to a payment.
Non-financial redress was also part of the proposal. The report called for improved access to public services for affected patients, alongside signposting to free emotional support. It recommended that people who had received relevant treatment through the NHS or the independent sector should be eligible for the proposed schemes.
Why families are seeking answers
Sodium valproate is prescribed for some people with epilepsy or bipolar disorder. Taking it during pregnancy can cause major birth defects and problems with a child’s development. The effects can be lifelong, although they do not occur in every pregnancy exposed to the medicine.
Some affected people are now adults. Families have described concerns about continuing care as parents grow older, as well as the years spent seeking recognition and support. The devolved ministers said the absence of a full response was causing anxiety and distress across the UK.
The 2024 report followed the Independent Medicines and Medical Devices Safety Review, chaired by Baroness Cumberlege. Its 2020 report called for separate redress schemes for people harmed by sodium valproate and pelvic mesh. The Government did not accept those redress recommendations at the time and later asked the patient safety commissioner to explore options.
Hughes’s role is limited to England, and her report discusses the need for the UK Government to work with the devolved administrations. The Welsh Government has said that regulation of medicines and medical devices is reserved to the UK Government.
Johnson told MPs that the Government’s discussions had considered the scope, affordability and practical challenges of a redress scheme. She also acknowledged the length of time families had waited. The devolved ministers are now seeking a full response that would give those affected a clearer understanding of the Government’s intentions.
Advice for people taking valproate
Valproate remains an important treatment for some patients. People taking it should not stop without first discussing it with a specialist, because keeping their condition managed is important.
Anyone taking valproate who is pregnant, thinks they may be pregnant or is planning a family should contact their doctor promptly to discuss their options. Prescribing restrictions and a pregnancy prevention programme are in place to reduce risks and support discussions between patients and healthcare professionals.
