Question to the Department of Health and Social Care:

To ask the Secretary of State for Health, what the implications are for his policies of the decision by the French parliament to establish a national compensation fund for people affected by the teratogenic effects of sodium valproate.

Valproate is an effective treatment for epilepsy and bipolar disorder but should only be used in girls and women of childbearing potential if other treatments are ineffective or not tolerated. For some women there may be no other treatment option. Since it was authorised, valproate was known to have risks in pregnancy. Because of ongoing concerns about women’s awareness of the risks, the Medicines and Healthcare products Regulatory Agency (MHRA) has worked with professional bodies, voluntary organisations and patient groups to develop a set of materials to aid communication between health professionals and women and girls. The valproate toolkit comprises booklets for healthcare professionals, a reminder card and a guide for women, a checklist for prescribers and clear package labelling carrying a prominent warning about use in pregnancy.

In order to monitor the effectiveness of the valproate toolkit, the MHRA has sought feedback from all stakeholders and will continue to work with the Royal Colleges, professional bodies, patient groups and relevant charities to increase awareness of the toolkit among general practitioners, pharmacists and patients. The MHRA’s current priority is working to ensure that women taking valproate are fully aware of the risks in pregnancy. Once this is achieved we will look back and see what lessons have been or could be usefully learnt by examining events.