Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what funds will be made available to ensure further research into the possible association between birth defects and persistent developmental disorders associated with paternal Valproate treatment.

The Medicines and Healthcare products Regulatory Agency (MHRA) has worked with professional bodies and healthcare organisations on implementing measures to raise awareness of the significant risks associated with sodium valproate in pregnancy and to support healthcare professionals to comply with the valproate Pregnancy Prevention Programme. This includes consideration of alternative treatment for girls and women of childbearing potential.

It is the responsibility of every healthcare professional involved in the prescribing and dispensing of valproate to make sure women are aware of the serious risks in pregnancy and are enrolled in the statutory Pregnancy Prevention Programme. United Kingdom Chief Medical Officers wrote to all healthcare professionals in April 2018 to inform them of the actions required and in September 2018 UK Chief Pharmaceutical Officers contacted all pharmacists to remind them of their responsibilities when dispensing valproate. This has been reinforced by messages from the professional regulators to their members and by articles in the MHRA’s electronic bulletin Drug Safety Update in September and again in December last year calling all healthcare professionals to examine whether they are prescribing in compliance with the new measures.

Professional bodies have produced guidance to support their members in the implementation of the Pregnancy Prevention Programme and The National Institute for Health and Care Excellence has produced an overarching prescribing guideline for valproate. The NHS England General Practitioner (GP) contract framework now includes a Quality Indicator for valproate prescribing which will incentivise GP practices to have a robust system in place to ensure compliance with the new measures.

The Care Quality Commission is checking compliance with the requirements of the valproate pregnancy prevention programme during routine inspections and investigating any complaints of non-compliance with these requirements.

The recent European review of valproate in pregnancy considered a possible association between birth defects and persistent developmental disorders associated with paternal valproate treatment at the time of conception. The review concluded that there was insufficient evidence at present to establish such a link, but further research was required. Therefore, as an outcome of the review the marketing authorisation holders of valproate products were required to undertake a retrospective observational study to investigate the association between paternal exposure to valproate and the risk of congenital anomalies and neurodevelopmental disorders including autism in their offspring. The design of the study is under evaluation by the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee.