Sodium valproate compensation: redress, legal claims and time limits

If you take valproate, do not stop taking it without first discussing it with your specialist. If you are planning a family, think you might be pregnant or know you are pregnant, the Medicines and Healthcare products Regulatory Agency (MHRA) says to contact your doctor at once.

This guide explains what the Hughes Report recommended, where the government's response stands, whether a legal claim is still possible and the time limits that apply. It is general information, not legal or medical advice. We are an independent information service, not a law firm.

Valproate in pregnancy: what the MHRA says

Valproate is prescribed for some patients with epilepsy or bipolar disorder. Valproate medicines include sodium valproate, valproic acid and valproate semisodium, and brand names include Belvo, Convulex, Depakote, Dyzantil, Epilim and Episenta. The Patient Safety Commissioner for England describes it as a life-saving drug which, when taken in pregnancy, harms the foetus.

According to the MHRA, in women who take valproate while pregnant around 1 in 9 babies (11%) will have a birth defect, and about 3 or 4 children in every 10 may have problems with early childhood development. Children exposed in the womb are also more likely to have autism or autism spectrum disorders.

Today valproate must not be prescribed to any woman or girl able to have children unless the conditions of the Pregnancy Prevention Programme are followed, and it should only be prescribed to patients under 55 when two specialists have agreed that other treatments do not work and the benefits outweigh the risks.

The Hughes Report on redress

The Patient Safety Commissioner for England, Professor Henrietta Hughes, published her report on options for redress for those harmed by valproate and pelvic mesh on 7 February 2024. It made 10 recommendations, including comprehensive non-financial redress and a two-stage financial redress scheme made up of an interim scheme and a main scheme.

The report recommended that applying should be straightforward, accessible and non-adversarial, with a presumption of truth when assessing patients' evidence. For valproate it defined the directly harmed as individuals whose mothers were taking valproate at any point during their pregnancy. Friends, families and loved ones who suffered as a result, including the mothers of children harmed by valproate, were treated as indirectly harmed. Its definitions were designed to align with the earlier First Do No Harm review chaired by Baroness Cumberlege. The final decision on eligibility rests with the government.

Where the government stands in 2026

• 7 May 2024: the Commissioner received an initial letter from a minister, but the government made no final decisions.
• October 2025: she used her power under Schedule 1, paragraph 3 of the Medicines and Medical Devices Act 2021 to request information, the first time the power had been used.
• 2 February 2026: she said a government update provided no timetable for decisions on financial compensation, and that the Department of Health and Social Care does not have the agency to deliver financial compensation, an authority that sits with the Treasury and Number 10.
• 31 March 2026: the Secretary of State reaffirmed the government's commitment to progressing a decision for financial redress within this Parliament.
• 26 June 2026: the Commissioner wrote to Number 10, using her statutory powers for the second time, with a deadline of 16 July.
• 14 July 2026: answering a written parliamentary question, the Department said there must be meaningful progress during this Parliament, although a decision to provide compensation has not yet been made. Answers on 15 September 2026 referred back to that reply.

The Commissioner's office says no redress scheme has yet been set up and it cannot advise on registration, so there is nothing to sign up for. It encourages patients to contact their local MP and the Department of Health and Social Care with their views on redress.

Can you bring a legal claim?

Against the manufacturer. Under section 2 of the Consumer Protection Act 1987, where damage is caused wholly or partly by a defect in a product, the producer is liable. A product is defective if its safety is not such as persons generally are entitled to expect, taking account of matters such as the instructions and warnings supplied with it (section 3). Two hard limits apply. Part I of the Act came into force on 1 March 1988 and does not cover products supplied by the producer before then (section 50(7)). And a claim cannot be brought more than ten years after the producer supplied the product: the right of action is extinguished, even for a child or someone who lacks capacity, and in England and Wales the court cannot disapply that limit (sections 11A, 28(7) and 33(1A) of the Limitation Act 1980; section 22A of the Prescription and Limitation (Scotland) Act 1973; article 8 of the Limitation (Northern Ireland) Order 1989).

For clinical negligence. A claim may be possible against a prescriber or health body if care fell below a reasonable standard, for example if the risks were not properly explained. In Montgomery v Lanarkshire Health Board [2015] UKSC 11 the Supreme Court held that a doctor is under a duty to take reasonable care to ensure that the patient is aware of any material risks involved in any recommended treatment. In England, clinical negligence claims against NHS trusts are handled by NHS Resolution's Clinical Negligence Scheme for Trusts, which covers incidents on or after 1 April 1995. See our guides to medical negligence claims, birth injury claims and defective product claims.

Time limits for valproate claims

For a negligence claim in England and Wales, the usual limit is three years from the injury or from the date of knowledge, if later (sections 11 and 14 of the Limitation Act 1980). Where the injured person was under a disability when the right to claim arose, the three years run from when the disability ends, and a disability means being a child or lacking capacity, within the meaning of the Mental Capacity Act 2005, to conduct legal proceedings (sections 28 and 38). In Scotland, time does not count while the person was under legal disability by reason of nonage (under 16) or unsoundness of mind (section 17(3)). Northern Ireland has similar rules for children and people of unsound mind (articles 47 and 48 of the 1989 Order).

The product liability long-stop is different. It runs from when the producer supplied the medicine, which was before the pregnancy, so it ends by the child's 10th birthday at the latest, whatever their age or capacity. Our guide to claiming for a child or dependant explains how claims are brought for someone else.

Support, reporting and the rest of the UK

The MHRA lists support networks for families affected by valproate, including the Independent Fetal Anticonvulsant Trust (INFACT) on 01253 799161 and the Organisation for Anti-Convulsant Syndrome (OACS) on 07904 200364. Anyone can report an issue with a medicine to the Yellow Card scheme, which the MHRA runs.

The Patient Safety Commissioner's role is limited to England, and her office suggests the UK Government works with the devolved administrations on redress. Scotland has its own office of Patient Safety Commissioner for Scotland under the Patient Safety Commissioner for Scotland Act 2023. For claims outside England, see our guides to medical negligence claims in Scotland, Wales and Northern Ireland.

Frequently asked questions

Related guides: birth injury claims, pelvic mesh claims, medical negligence claims, defective product claims and time limits.

Official sources used for this guide: MHRA: Valproate reproductive risks; Patient Safety Commissioner: Redress; Written question 16121, answered 14 July 2026; Consumer Protection Act 1987, s.2; Limitation Act 1980, s.11A. This guide is general information about the law in the UK, not legal advice; the law can change, so check your own position with a regulated solicitor.