AlphaMED Resources · https://alphamedicine.uk/Resources/cases/valproate-redress
Valproate harm and the redress delay
Sodium valproate, sold as Epilim, can harm babies whose mothers took it in pregnancy. The 2020 review and the 2024 Hughes report both called for redress. As of October 2026 government has announced neither a scheme nor a timetable.
- Cumberlege review calls for an apology and redress
- Two specialist rule for under 55s takes effect
- Hughes report proposes a two stage redress scheme
- MHRA advises men on contraception
- Government says no decision on compensation has been made
Summary
- Sodium valproate, sold as Epilim, is prescribed for some patients with epilepsy or bipolar disorder. Taken in pregnancy, it harms the unborn child.
- The 2020 review cited research that 10% of exposed unborn children are likely to have physical birth defects, and 40% will have developmental delay or autism. The review, First Do No Harm, said that "the system, and those that oversee it, need to acknowledge what has gone so badly wrong".
- Ministers apologised on the day the review was published, but payment stayed open. In February 2024 the Patient Safety Commissioner, Henrietta Hughes, proposed a two stage scheme: a fixed interim payment, then a main payment based on each person's needs.
- Since 31 January 2024, valproate must not be started in new patients younger than 55, men or women, unless two specialists document that there is no other effective or tolerated treatment.
- Government has not decided. On 14 July 2026 it told Parliament that a decision to provide compensation has not yet been made. On 9 October it still referred MPs back to that answer.
Dig deeper
- The Hughes report does not set the size of the interim payment. Its survey median was £100,000 for responses about valproate, and £25,000 for valproate and pelvic mesh combined.
- The government says the matter is complex. In January it told Parliament that it involves multiple organisations.
- In February Wes Streeting, then Health Secretary, said he would respond before the next general election.
- Families can't wait any longer. A campaigner who founded Valproate Victims said in February 2025 that "they should all have to reach into their pockets to compensate our children".
- For men, the MHRA said in September 2024 that children fathered by men on valproate may face a small increased risk of neurodevelopmental disorders. Men and their partners should use effective contraception during treatment and for at least three months after stopping.
- The same question of who pays for medical harm runs through the Infected Blood Scandal.
Ethical issues
| Principle | How it applies here |
|---|---|
| Autonomy | A woman can only weigh the risk of pregnancy on valproate if she has been told it. The 2020 review could not say how many women over four decades became pregnant without being properly informed. |
| Beneficence | Valproate may be the most effective treatment for some genetic generalised epilepsies, and uncontrolled tonic clonic seizures are the biggest risk factor for SUDEP, so stopping without advice has its own danger. The 2024 rule protects future babies but narrows who can start it. |
| Non maleficence | The children harmed never chose the exposure. The duty to prevent harm fell on the regulator, the prescriber and the manufacturer, and the review found that action took decades after the concerns were raised. |
| Justice | Who pays is the open question. France set up a public fund for valproate taken in pregnancy before 31 December 2015. The review said Sanofi and the government should both contribute, but Sanofi's own statement does not mention compensation. The Hughes report says an interim payment would help count those harmed, so a main scheme can be costed. |
Interview questions
- What do you know about the valproate scandal and the Cumberlege review?
- What did the Hughes report propose, and how do its interim and main schemes differ?
- A 34 year old man on valproate tells you he is planning a family next year. What do you tell him, and what do you need to check first?
- Why does a medicine that can harm an unborn child still get prescribed to some patients?
- Should the state or the manufacturer pay compensation for harm from a licensed medicine? What is the case for each?
- A patient with epilepsy wants to stop valproate because of pregnancy worries, and has not yet seen a specialist. How do you weigh the risks on each side?
- How would you explain the difference between a prescribing rule and a redress scheme to a patient?
Sources
- GOV.UKgov.uk/…/valproate-reproductive-risks
- immdsreview.org.ukimmdsreview.org.uk/…/IMMDSReview_Web.pdf
- patientsafetycommissioner.org.ukpatientsafetycommissioner.org.uk/…/Redress-Report_.pdf
- GOV.UKgov.uk/…/new-valproate-safety-measures-apply-from-31-january
- questions-statements.parliament.ukquestions-statements.parliament.uk/…/16121
- questions-statements.parliament.ukquestions-statements.parliament.uk/…/107356
- epilepsy.org.ukepilepsy.org.uk/…/valproate-scandal-compensation-wes-streeting-commits-to-resp
- epilepsy.org.ukepilepsy.org.uk/…/valproate-families-cant-wait-any-longer-for-redress
- GOV.UKgov.uk/…/mhra-advises-men-taking-valproate-and-their-partners-to-use-
- theabn.orgtheabn.org/…/Updated-ABN-Guidance-on-Valproate-prescribing-following-MHRA
- epilepsy.org.ukepilepsy.org.uk/…/sudep
- sanofi.comsanofi.com/…/sodium-valproate
Photo: Colin, public domain, via Wikimedia Commons, colour altered.
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