FOI release

Freedom of Information request on groups and/or Sub Groups, comprising of experts and/or patients relating to reviews on Sodium Valproate (FOI 21/448)

Published 28 June 2021

25th May 2021 FOI 21/448 Dear

Thank you of your email of 26th April 2021 where you requested the following information:

How many Groups and/or Sub Groups, comprising of experts, patients and/or both, have been set up in relation to, and/or to examine information relating to I. The IMMDS Review II. The IMMDS Recommendations III. The safety of Sodium valproate in pregnancy IV. The updating of Contraindications of Sodium Valproate

The MHRA Board has been carefully considering the Independent Medicines and Medical Devices Safety (IMMDS) Review and the recommendations made, and how the Agency is responding to and implementing the recommendations. The Executive Committee (and its predecessor, the Corporate Executive Team) has been advising and monitoring progress of the Agency’s response to the Review. Further details of membership of the Board and Executive Committee can be found here.

The Agency is strengthening leadership and board assurance, with the recruitment of a new Chief Safety Officer and the establishment of a new Patient Safety and Engagement Committee. The Patient Safety and Engagement Committee is a new assurance committee of the Board which will include two lay members.

The new Chief Safety Officer will lead the implementation of the recommendations from the Cumberlege Review and will be overseeing the development of a revitalised approach to vigilance of both medicines and medical devices.

The purpose of the Patient Safety and Engagement Committee is to provide independent consideration of patient safety and patient engagement and to advise the Board accordingly. In detail, the Committee’s specific duties and responsibilities are to:

a) Monitor and advise the Board on aspects of patient safety in the Agency’s procedures for its initial assessments of medicines, medical devices and blood products, the continued surveillance of their use, and processes for dealing with information derived from surveillance such that patient safety is the primary priority and that there is a culture of continuous, iterative improvement.

b) To consider, and advise the Board on all aspects of the ways in which the Agency engages with patients and with the public, such that patient views are consistently considered in regulatory decision-making; the Agency is responsive to the needs of patients and their concepts of risks and benefits, in its consideration of patient safety; and processes are in place to encourage and acquire information from patients, and to inform them, at all stages of the Agency’s regulation of medicines, medical devices and blood products.

The Committee will comprise a minimum of three Non-Executive Directors of the MHRA, one of whom will be appointed as Chair of the Committee and three Executive Directors. Two lay members will also be appointed on the Committee in line with the recruitment principles of the Agency’s Expert Committees.

The Executive Committee has a sub-committee, called the Delivery and Performance Committee, which will also be considering progress made in response to the Review and its recommendations to provide assurance on delivery. Finally, a IMMDS Review co-ordination group was created to ensure that the necessary support and evidence required to assist the Review was provided, and to co-ordinate internal activities and consider information relating to the Review.

MHRA has a number of independent advisory committees to provide advice on data relating to the safety, quality and efficacy of medicines, including the safety of sodium valproate in pregnancy.

The Commission on Human Medicines (CHM) has a function is to advise Health Ministers and the MHRA on matters relating to human medicinal products. The CHM established a specific sodium valproate expert working group (SVEWG) to focus on the safety of sodium valproate in pregnancy.

In addition to the dedicated SVEWG, the CHM has received advice on the safety of sodium valproate from two established expert advisory groups, the Pharmacovigilance Expert Advisory Group (PEAG) and the Neurology/Pain and Psychiatry Expert Advisory Group (NPPEAG). PEAG provides advice on safety issues including identifying and quantifying risks, risk minimisation and communications. NPPEAG advises on the safety and efficacy of medicines for use in neurological conditions, pain management and psychiatric conditions. Although PEAG and NPPEAG were not set up to specifically examine information relating to the IMMDS review and its recommendations, they have provided advice on the safety of sodium valproate and updating the contraindications for sodium valproate. The CHM considers the advice from its advisory committees as part of their decision making process.

A list of the most recent discussions of valproate at the CHM or one of its advisory groups can be found at annex 1.

The Valproate Stakeholder Network (VSN) established in In 2016 consists of representatives from over 40 different organisations including: healthcare professional bodies, health system delivery agencies and regulators, patient groups and research charities (for the indications of bipolar, epilepsy and migraine) plus campaign groups representing the families affected. The VSN was formed to support a communications drive around the valproate toolkit to raise awareness among women of the risks. It is now focussed on consistent UK-wide implementation of the valproate Pregnancy Prevention Programme as required by the licence, and monitoring compliance.

I hope the information provided is helpful, but if you are dissatisfied with the handling of your request, you have the right to ask for an internal review. Internal review requests should be submitted within two months of the date of this response; and can be addressed to this email address.

Please remember to quote the reference number above in any future communications.

If you are not content with the outcome of the internal review, you have the right to apply directly to the Information Commissioner for a decision.

The Information Commissioner can be contacted at: Information Commissioner’s Office, Wycliffe House, Water Lane, Wilmslow, Cheshire, SK9 5AF If you have a query about this letter, please contact me.

Yours sincerely, FOI Team, Vigilance and Risk Management of Medicines Division