Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, with reference to his letter to INFACT of 3 December 2021, in addition to the pregnancy prevention programme, what steps he is taking to ensure that (a) the future safety and (b) further support is directly improved for people and families affected by Sodium Valproate.

In addition to the valproate pregnancy prevention programme, future safety of valproate is managed within the Medicines in Pregnancy Valproate Registry, based on a core register comprising routinely collected data. The Registry currently includes all women in England who are receiving National Health Service-prescribed valproate and identifies when they are pregnant and accessing NHS care for that pregnancy. Work is ongoing to extend the registry to include women in the devolved administrations.

The Medicines and Healthcare products Regulatory Agency will shortly bring forward legislation to support the implementation of medicines registries and improve systematic collection of data. This will ensure that neurodevelopmental disorders associated with valproate are better characterised and identified earlier if associated with other antiepileptic drugs.

As set out in the Government’s response to the Independent Medicines and Medical Devices Safety Review, published on 21 July 2021, we are working to improve the care pathways for children and families affected by medicines in pregnancy, including valproate. This includes tackling the variation in access to services across NHS regions to ensure that care is co-ordinated.