Concerning lack of response from government

Published: July 06 2021
Last updated: October 11 2022

Epilepsy Action has expressed concern over the lack of response from the government on specific recommendations made by the Cumberlege report in July 2020 on sodium valproate.The first response from the government came the day after the publication of the report that followed the Independent Medicines and Medical Devices Safety Review, chaired by Baroness Julia Cumberlege. The Minister for Patient Safety, Mental Health and Suicide Prevention, Nadine Dorries, made an apology in parliament, on behalf of the government, to the women and families affected by these medical products.

However, not much more was said at the time. Epilepsy Action has criticised the government for taking six months to respond to many of the recommendations, and for a lack of response altogether to some valproate-specific recommendations. A full response is still awaited a year on.

Epilepsy Action has said it is “very disappointing” that the government did not respond directly to the specific recommendations around sodium valproate. The organisation has called on the government to address these when it responds in full.

Valproate-specific recommendations

These recommendations include developing measures to support safe prescribing in pregnancy, clear counselling around epilepsy medicines and contraception and an effort to identify, diagnose and support those affected by valproate exposure. Other recommendations included creating a registry for women taking epilepsy medicines in pregnancy, improvements to the pregnancy prevention programme (PPP) and urging clinicians to follow prescription guidance for valproate.

Despite a lack of direct response, Daniel Jennings, senior policy and campaigns officer at Epilepsy Action, explained what work appears to be ongoing and what has yet to be done. He said: “The government has not responded directly to any of these recommendations.

“With regard to counselling and contraception, while preconception counselling is available in some areas, much more needs to be done to ensure that women with epilepsy are able to access this service as standard. This can ensure that they have the necessary information to make an informed choice about their care and treatment during pregnancy.

“We understand that work is ongoing in individual trusts to identify, diagnose and support those affected by valproate exposure in pregnancy. But, as many women were unaware of risks at the time they were taking valproate, it is difficult to identify all those who may have been affected. Access to diagnosis and support is still not sufficient, especially without a redress scheme in place.

“A valproate registry has been established and has published an initial report. While it has been confirmed that other epilepsy medicines will be included in future iterations of the registry, this has yet to happen.

“Regarding the PPP – all women and girls of childbearing potential have been written to, but much more needs to be done to improve the PPP.

“And while further measures have been introduced to communicate the need for clinicians to continue to follow prescribing guidance for valproate, it is unclear whether this is happening in practice. This is particularly concerning given past concerns about the lack of communication with women and girls.”

Other recommendations

The Cumberlege report also recommended the appointment of a Patient Safety Commissioner to be an independent advocate for patients. This was accepted by the government. The role and powers of the Commissioner are now written in the Medicines and Medical Devices Act 2021. However, the government is still consulting on the details of appointing a person in the role, and how they will work.

Another recommendation made was about a scheme to meet the costs of additional care and support needed by those who have been harmed by these medical products. This is still under consideration by the government.

Daniel said: “Although they have stated that they are “carefully considering” a redress scheme for those harmed by sodium valproate, no further progress has been made. Again, this is very disappointing, given the harm families have experienced. A compensation scheme was established in France and Epilepsy Action has called for a similar scheme to be set up in the UK.”

Epilepsy Action said that while some important progress has been made, there are far too many areas still awaiting action and further response from the government.

“It took six months before the government produced their initial response to the Cumberlege report, and a further six months on, we are still awaiting their full reply”, Daniel said.

Epilepsy Action advises that women should not stop taking their medicines without speaking to a doctor first. Stopping medicine may result in breakthrough or increased seizures and may be harmful to the woman and any unborn baby. There is more information about sodium valproate on the Epilepsy Action website and people can also contact the Epilepsy Action Helpline.