A coalition of epilepsy charities has expressed its loss of confidence in the Medicines and Healthcare products Regulatory Agency (MHRA) over proposed changes to the regulatory policy for sodium valproate.
The coalition emailed the MHRA ahead of its meeting today (June 21, 2023) to express its loss of confidence and to call for the gov.uk drug safety update of December 12, 2022, to be taken down immediately.
The coalition of charities includes Epilepsy Action, SUDEP Action, Epilepsy Society, the ILAE, Epilepsy Scotland, ESNA, Epilepsy Research UK, Epilepsy Connections, Young Epilepsy, Epilepsy Wales and Quarriers.
Published on December 12, 2022, the new safety measures for valproate state: “All people under 55 (including boys and men for the ﬁrst time) who are prescribed sodium valproate need to have two signatures from specialists documenting that no other suitable alternative medication has been effective or tolerated”.
The statement in full
A medicines regulatory policy published on December 12, 2022, for valproate contained new safety measures for valproate-containing medicines to be put in place in the coming months. The measures followed a review of the latest safety data by the Commission of Human Medicines and stipulated:
all people under 55 (including boys and men for the ﬁrst time) that are prescribed sodium valproate to have two signatures from specialists documenting that no other suitable alternative medication has been effective or tolerated
An Epilepsy Coalition of UK epilepsy organisations came together in January 2023 to make an urgent call for a decision by the Medicines and Healthcare products Regulatory Agency (MHRA) to be paused in January because epilepsy clinical and patient organisations had not seen the scientific rationale for the policy and had not been involved or consulted. Two Freedom of Information requests were denied and three formal letters were not responded to. On March 23 the Epilepsy Coalition escalated our concerns to the NHS and in a letter with a call for action and a request to meet with the Secretary of State for Health and Social Care, which you can read here.
We are calling for an urgent review and scrutiny of this policy; evidence of a commitment to invest in a minimum framework for the safeguarding of life and to invest in research. We have received no answer to this.
The charities and our beneﬁciaries need to see and be consulted on the scientiﬁc basis for the regulatory decision that was published on December 12, and the impact it is likely to have on patient safety. This has not happened yet and because the policy is published, and the policy is a dramatic shift in practice and risk and is controversial, there is a lot of confusion and variation in how organisations and individuals have been responding since December.
The policy is also causing confusion internationally as it diverges from the practice of European and other countries around the world who are aware of a summary of a European research study and its limitations and have either just added a sentence to their patient information leaflets or are keeping their policy under review as they wait for further research to be able to progress medicines regulatory policy.
We have now just learnt from you and Sanofi that a recent thorough data review by the company since the UK policy Update of 12th December 2022 was published considers the safety study has limitations.
Sanofi states that these issues need to be resolved before final decisions can be made.
Although there has not been openness in the UK, the study was reported in the spring to other countries and you can read one example here what the finding was, the limitations and what another country decided to do.
We have emailed the MHRA ahead of the meeting on June 21 to express our loss of confidence and to call for the gov.uk drug safety update of December 12, 2022, to be taken down immediately and that information is now released under the Freedom of Information requests of December 21 to us. The charities and our beneﬁciaries need to see and be consulted on the scientiﬁc basis for the regulatory decision and the impact it is likely to have on patient safety. Ministers and the MHRA must pause now and allow time for a considered response to be given to the recommendations made in our letter of March 23.
The Coalition is concerned that medicines regulatory policy must be robust and that any change has regard to each person’s situation and life choices and is in proportion to the risks to patient safety. Valproate remains the most effective medicine for people who may experience life-threatening seizures and other harms.
Patients need counselling to have the option of shared decision-making, balancing the benefits of different treatments with the risks of different treatments, to enable informed consent to treatment that would be expected for any other condition and patient community.
The coalition is clear that our position does not prevent the government, the NHS and the MHRA moving to including epilepsy as a poorly served community in national and local planning of improvements. For women this must include investing in the necessary workforce to ensure all women receive preconception counselling and an opportunity for shared decision-making and informed consent with the information they need to be able to engage. The coalition has offered its networks of people with epilepsy and affected by epilepsy to support.