Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, whether the Independent Medicines and Medical Devices Safety Review Patient reference group was set up to discuss the (a) three interventions of Valproate, Mesh and Primodos involved in that review and (b) future of patients and their welfare within the health system.

The Department has not established any groups or sub-groups on sodium valproate or medications in pregnancy.

The Department has established a Patient Reference Group (PRG) in 2020 consisting of patients and patients’ representatives, including those involved in the Independent Medicines and Medical Devices Safety (IMMDS) Review and those with a wider interest in patient safety. The purpose of the PRG is to provide challenge, advice and scrutiny to the work to develop the Government’s response to the recommendations set out in the IMMDS Review. The scope of the PRG does not extend beyond the recommendations in the Review.

The Medicines and Healthcare Products Regulatory Agency (MHRA) has established groups on sodium valproate and medications in pregnancy. The Sodium Valproate Expert Working Group of the Commission on Human Medicines was convened in February 2014 to advise the Commission on Human Medicines on the risks of valproate in pregnancy and on measures to minimise risk. The MHRA convened the Valproate Stakeholder Network in January 2016 to support communications around the valproate toolkit to raise awareness among women of the risks. It is now focused on consistent UK-wide implementation of the valproate Pregnancy Prevention Programme and monitoring compliance.

In July 2019 the Commission on Human Medicines established a new Expert Working Group on Optimising Data on Medicines used in Pregnancy. The Expert Group was to advise on better ways to collect and monitor data on the safety of medicines during pregnancy. The report and recommendations of the Expert Group were published in January 2021.