Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, with reference to the Independent Medicines and Medical Devices Safety (IMMDS) Review and the publication of its report in July 2020, how many (a) groups and (b) sub groups have been established in respect of (i) sodium valproate, (ii) medications in pregnancy, (iii) the IMMDS Review and (iv) the recommendations of that review since the publication of the valproate toolkit in 2015.

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) 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 discuss all recommendations set out in the Review and to provide challenge, advice and scrutiny to the work to develop the Government’s response. 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.

NHS England and Improvement has established groups on sodium valproate and the IMMDS Review. The National Director of Patient Safety set up a clinically-led Valproate Safety Implementation Group in June 2020, with 3 further subgroups.

The Pelvic Floor Health Oversight Group continues the work of previously established stakeholder groups responsible for setting and communicating the conditions of the national pause on vaginal mesh insertion procedures in July 2018 and has also been considering the pelvic mesh related recommendations from the IMMDS Review. A subgroup has also been established to support delivery against data and registry related conditions of the national pause and is considering data related actions from the Review on pelvic mesh. An expert reference group steering the establishment of perinatal pelvic health services is also considering actions related to postnatal pelvic physiotherapy from the Review.