The Scottish Government has joined Wales and Northern Ireland in demanding an urgent decision from the UK Government over compensation for families affected by sodium valproate, an epilepsy medicine linked to serious birth defects and lifelong developmental disabilities.
The intervention follows more than two and a half years of waiting for a formal response to an independent report recommending financial compensation and specialist support for people harmed by the medicine. Although the report proposed that initial payments should begin in 2025, the UK Government has yet to approve a compensation scheme or provide a timetable for reaching a decision.
In a joint letter published on 10 November, Scotland’s Public Health Minister Maree Todd, Welsh Health Minister Mabon ap Gwynfor and Northern Ireland’s Health Minister Robbie Butler called on the UK Minister of State for Public Health and Patient Safety, Dame Diana Johnson, to clarify the government’s intentions.
The ministers said they had repeatedly raised the delay with successive UK ministers since July 2024. Their latest intervention follows a parliamentary debate on 29 October in which Johnson confirmed that no decision had been made on financial redress and that she could not provide a timetable.
For affected Scottish families, the dispute concerns much more than compensation. Some children exposed to valproate during pregnancy have developed physical disabilities, learning difficulties and complex health conditions requiring specialist treatment and continuing support. Many of those children are now adults.
A Medicine That Can Cause Lifelong Harm
Sodium valproate, widely known through brand names including Epilim, has been prescribed for decades to control epilepsy. It is also used to treat bipolar disorder and, in some circumstances, other conditions.
The medicine remains an important treatment for some patients, particularly those whose epilepsy cannot be adequately controlled with alternatives. However, its use during pregnancy carries well-established risks.
According to the Medicines and Healthcare products Regulatory Agency (MHRA), approximately 11% of babies exposed to valproate during pregnancy will have a birth defect. Between 30% and 40% of exposed children may experience developmental difficulties.
These can include spina bifida, heart abnormalities, facial malformations, delayed speech and walking, impaired memory and learning difficulties. Research has also established an increased risk of autism among children exposed to the medicine before birth.
Not every exposed child develops these conditions, but the risks are sufficiently serious that strict prescribing restrictions now apply.
The scale of the harm prompted the Independent Medicines and Medical Devices Safety Review, chaired by Baroness Julia Cumberlege, which published its findings in July 2020.
Its report, First Do No Harm, examined failures involving sodium valproate, pelvic mesh implants and the hormone pregnancy test Primodos. It documented how patients and families had repeatedly struggled to have their concerns recognised by healthcare institutions and regulatory authorities.
The review recommended independent arrangements for financial redress, recognising that conventional legal proceedings could place significant burdens on families already dealing with the consequences of medical harm.
The recommendations for an independent redress agency and dedicated compensation schemes were not accepted by the UK Government at that time.
Compensation Was Supposed to Begin in 2025
In February 2024, England’s Patient Safety Commissioner, Henrietta Hughes, published a further investigation into how compensation could be provided to people affected by valproate and pelvic mesh.
The Hughes Report proposed a two-stage scheme.
An initial scheme would provide eligible patients with a fixed payment recognising avoidable harm resulting from failures across healthcare and medicines regulation. A subsequent scheme would consider individual circumstances, including the severity of disabilities, continuing care requirements and financial losses.
The report proposed making interim payments during 2025 rather than leaving families without assistance while a more detailed compensation system was developed.
Patient evidence collected for the investigation illustrated the potential financial consequences. Among survey respondents affected by valproate, the median suggested interim payment was £100,000.
That figure was not an approved compensation award or a specific payment rate recommended by the commissioner. It represented the median amount proposed by affected respondents. The report deliberately left the eventual payment level for ministers to determine.
Hughes also recommended assistance beyond financial compensation, including improved access to specialist medical services, educational support, help with social security arrangements and housing adaptations.
The proposals recognised that financial assistance alone could not address the difficulties faced by children and adults living with complex disabilities.
More than two years later, however, the recommended interim scheme has not been established.
The Patient Safety Commissioner’s office confirms that no registration process exists and that eligibility cannot yet be determined because ministers have not approved a scheme.
New Scottish Figures Show Exposure Has Not Entirely Ended
The compensation dispute concerns harm accumulated over decades, but sodium valproate continues to be prescribed in Scotland under increasingly strict safety controls.
Figures published by Public Health Scotland on 6 October 2026 show that 1,866 females aged under 55 were prescribed valproate during January to March 2026.
That represents a 56% reduction from the 4,237 recorded during April to June 2018, when strengthened pregnancy prevention measures were introduced.
The latest figures also identified two pregnancies exposed to valproate between July 2025 and March 2026. One was associated with a prescription recorded as a new start during pregnancy, although Public Health Scotland cautioned that an earlier prescription history might not have been available.
The pregnancy figures remain incomplete because some pregnancies were still ongoing or had not been fully captured when the data was extracted. The figures do not establish whether prescribing rules were breached or whether either pregnancy resulted in harm.
Nevertheless, they demonstrate why continued monitoring remains necessary.
Under current UK regulatory arrangements, valproate is subject to specialist prescribing restrictions. Women and girls who could become pregnant must meet the conditions of a pregnancy prevention programme if treatment is considered necessary.
Additional prescribing controls introduced from January 2024 require two specialists to agree that there is no suitable alternative before certain patients under 55 begin treatment.
The restrictions aim to prevent further avoidable harm while allowing patients who need the medicine to continue receiving effective treatment.
Patients taking valproate should not discontinue it without specialist medical advice, as abruptly stopping treatment can have serious consequences.
Why Scotland Cannot Resolve the Compensation Question Alone
Healthcare delivery is devolved, but medicines regulation operates across the United Kingdom.
That division of responsibility is central to the present dispute.
The Hughes Report was commissioned through the UK Government and produced by the Patient Safety Commissioner for England. Its recommendations acknowledge that people in Scotland, Wales and Northern Ireland have also been affected and that a coordinated approach would be needed.
In an earlier answer to the Scottish Parliament, the Scottish Government said it had received no substantial UK Government proposals for financial redress and did not consider itself able to develop a scheme independently of decisions at Westminster.
The devolved governments have now repeated their willingness to participate in discussions, while insisting that the UK Government must explain how it intends to proceed.
The letter of 10 November states that officials from all three administrations are already meeting regularly with their UK counterparts. It also records concern that the Westminster debate had produced neither a decision on compensation nor a deadline.
In that debate, Johnson acknowledged the length of time families had waited. She said the government was examining the scope, affordability and practical difficulties of a compensation scheme.
She also outlined work being undertaken in England to improve specialist services and evaluate new arrangements for assessing people affected by exposure to medicines during pregnancy.
Those developments address some aspects of patient care, but do not amount to approval of the financial redress recommended in 2024.
Families Face Continuing Costs
The Hughes Report identified consequences extending beyond the initial medical injuries.
Families described difficulties obtaining diagnoses, securing appropriate educational provision, accessing benefits and navigating healthcare and social services.
For some, these problems continued as children reached adulthood, when arrangements for education, disability assistance, employment and independent living changed.
The report also recognised the position of parents and other relatives whose lives had been substantially affected by providing care.
Its proposed main compensation scheme would consider support for those indirectly harmed, subject to further consultation and decisions about eligibility.
Another difficulty is the absence of a comprehensive official record of everyone affected.
In a parliamentary answer in July 2025, the UK Department of Health and Social Care acknowledged that it did not collect information establishing the total number of people harmed by sodium valproate during pregnancy.
The MHRA had received 1,169 UK reports of suspected adverse drug reactions associated with valproate use during pregnancy up to 24 June 2025. Most involved birth defects or developmental delays.
Those reports are not a complete count of affected individuals. The figures cannot be used to calculate the full number of people who might qualify for compensation.
The Hughes Report envisaged that an initial scheme would help identify the affected population, providing a clearer basis for the more comprehensive arrangements that would follow.
Ministers Demand a Decision
Maree Todd said the continuing delay was creating additional uncertainty for families already living with the consequences of valproate exposure.
“The continued absence of a response to the Hughes report from the UK Government is causing significant anxiety and distress for those seeking clarity about what happens next.”
The Scottish minister said the affected families had waited too long for certainty and called for the UK Government to publish its response.
The letter from the three devolved administrations stops short of setting a deadline. Instead, it asks Johnson to explain the government’s intended approach at the earliest opportunity.
The immediate unresolved question is whether the UK Government will accept the principle of a dedicated financial redress scheme, establish eligibility criteria and identify when payments could begin.
For people affected by sodium valproate in Scotland, recognition of the medicine’s risks and the failures documented by successive independent investigations has not yet been followed by the comprehensive compensation arrangements those investigations recommended.
The government must still decide whether to establish such a scheme, how it would operate across the four nations and what assistance it would provide to families whose care needs continue.
Sources
Devolved Governments Urge Action on Delayed Hughes Report Response. Scottish Government, 11 November 2026.
https://www.gov.scot/news/devolved-governments-urge-action-on-delayed-hughes-report-response/
Hughes Report: Letter to UK Government. Scottish Government, 10 November 2026.
https://www.gov.scot/publications/hughes-report-letter-to-uk-government/
The Hughes Report: Options for Redress for Those Harmed by Valproate and Pelvic Mesh. Patient Safety Commissioner, 7 February 2024.
https://www.patientsafetycommissioner.org.uk/wp-content/uploads/2024/02/Redress-Report_.pdf
Recommendations and Government Responses. Patient Safety Commissioner, accessed 11 November 2026.
https://www.patientsafetycommissioner.org.uk/our-work/recommendations/
Anti-Seizure Medicines in Pregnancy: April 2018 to March 2026. Public Health Scotland, 6 October 2026.
https://publichealthscotland.scot/publications/anti-seizure-medicines-in-pregnancy/anti-seizure-medicines-in-pregnancy-6-october-2026/
Valproate – Reproductive Risks. Medicines and Healthcare products Regulatory Agency, 10 June 2025, updated 23 September 2025.
https://www.gov.uk/guidance/valproate-reproductive-risks
Sodium Valproate: House of Commons Debate. UK Parliament, Hansard, 29 October 2026.
https://hansard.parliament.uk/Commons/2026-10-29/debates/58ad60f7-8bd3-4d46-94f5-b38c6fd42c99/CommonsChamber
Pelvic Mesh and Sodium Valproate. House of Commons Library, 23 October 2026.
https://commonslibrary.parliament.uk/research-briefings/cbp-10487/
Independent Medicines and Medical Devices Safety Review Report. Department of Health and Social Care, 8 July 2020.
https://www.gov.uk/government/publications/independent-medicines-and-medical-devices-safety-review-report
Sodium Valproate: Number of People Harmed, Written Parliamentary Answer. UK Parliament, 16 July 2025.
https://questions-statements.parliament.uk/written-questions/detail/2025-07-08/65755/
