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 plans to (a) mandate central tracking and annual reporting on how many women (i) received the Pregnancy Protection Porgramme and (ii) signed the risk acknowledgement form.

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

There are no plans to mandate central tracking and annual reporting on how many women (i) received the Pregnancy Protection Programme and (ii) signed the risk acknowledgement form.

This is because such a measure would not be helpful, at an aggregated and anonymised level without a holistic review of each patient’s clinical and social circumstances. This could only be achieved with a national clinical audit. Such audits are expensive and can only be justified when there is significant room for improvement in outcomes, which is not the case in this instance.