Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, pursuant to the Answer of 23 July 2025 to Question 68387 on Epilepsy and Pregnancy: Sodium Valproate, whether his Department is taking steps to guarantee that every female valproate patient aged 13-54 received documented counselling and signs the annual risk form before continuing treatment.

NHS England has worked collaboratively with the Medicines and Healthcare products Regulatory Agency (MHRA) on the safer use of valproate containing medicines.

The Medicines and Pregnancy Registry monitors prescribing of valproate and highlights the number of pregnancies potentially exposed to valproate. The Registry is available at the following link: https://tabanalytics.data.england.nhs.uk/t/Public/views/MedsPreg/TitlePage?%3Aembed=y&%3Aiid=1&%3AisGuestRedirectFromVizportal=y.

This data demonstrates a reduction in prescribing valproate to women and girls as well as a reduction in the number of possible exposed pregnancies since the Pregnancy Prevention Programme (PPP) was introduced in 2018. Analysis shows the implementation of the PPP by ICBs is consistent across the country.

No such guarantee is being pursued. The existing measures described above including the regulatory position is a strong statement of the expected quality of care which is monitored through the Medicines and Pregnancy Registry.