UK government rejects call for redress schemes for people affected by valproate scandal

23 Jul 2021

The government has rejected the recommendation to set up redress schemes for valproate, Primodos and pelvic mesh, in its full response to the Independent Medicines and Medical Devices Safety (IMMDS) review.

The IMMDS review’s report was published in July 2020 and included nine main recommendations for the government to support people affected by these medical products and safeguard the public going forward. The report also included a number of specific recommendations on valproate. The government took six months to set out its initial response to the recommendations and over a year for the full response.

In the latest response, the government rejected the recommendation to set up separate redress schemes for people affected by the three medical products the safety review focussed on. Minister of State for Patient Safety, Suicide Prevention and Mental Health, Nadine Dorries, said: “While the government is sympathetic to the experiences of those patients who gave evidence to the report, our priority is to improve the future safety of medicines and medical devices.”

Daniel Jennings, Epilepsy Action senior policy and campaigns officer, said this outcome is a devastating  blow to families affected by the medical products. “We are hugely frustrated and saddened that the government has rejected the recommendation to set up a redress scheme for the many families who experienced avoidable harm and have additional needs because of valproate. The scheme would have provided much-needed and overdue help with the costs of these additional needs and enabled families to plan for the future.”

The government also rejected a part of the recommendation to create specialist centres for people affected by the three products. Specialist centres for people affected by pelvic mesh have been set up, but the government has not agreed to set up any such centres for people affected by medicines used in pregnancy. Ms Dorries said the government didn’t believe this was “the most effective way forward”. She said the government would work on improving care for this group within the existing health services.

The latest response mentioned the sodium valproate registry, adding that a second report from it is planned for September 2021. Plans were set out to include the whole of the UK in the registry, as well as other epilepsy medicine in addition to valproate. Ms Dorries also mentioned the letter the NHS sent to women and girls in England who are prescribed sodium valproate. She said the Medicines and Healthcare products Regulatory Agency (MHRA) will work to ensure that pharmacists have to supply sodium valproate in the manufacturer’s original packaging, to help make sure the patient information leaflet is always included.

However, the response does not address the report’s other valproate specific recommendations, such as establishing a clear process to ensure women are able to get appropriate counselling related to their epilepsy treatment and contraceptive choices.

Mr Jennings said: “Again, the government has not responded to the specific recommendations on valproate in the Cumberlege (IMMDS) review. We wrote to the minister on the anniversary of the Cumberlege review’s publication, outlining our concerns about the lack of progress, but are still awaiting a reply.”

The outlined concerns include improving access to preconception counselling, identifying, diagnosing and supporting those affected by valproate exposure, improving the pregnancy prevention programme and better communication from clinicians.

“We will continue to work with MPs and others to ensure that the needs of those families harmed by valproate, and the needs of women and girls  taking valproate – now and in the future – are met,” he added.

The government’s early response accepted a number of the recommendations, including issuing an apology, appointing a patient safety commissioner and the creation of the valproate registry. However, it did not accept a number of recommendations, including creating a redress agency for those harmed by the medical products and the creation of a task force to implement the review recommendations.

Epilepsy Action has previously criticised the government for taking six months to respond to many of the recommendations in the first place, and for a lack of response altogether to some valproate-specific recommendations.

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.


You may also be interested in...

Concerning lack of response from government to sodium valproate recommendations on Cumberlege report anniversary

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.

Comments: read the 1 comments or add yours


OACS Charity UK are Extremely disappointed with the attitude of the UK Governments dismissal of the 20,000 plus Children Harmed by Valproate in the UK. As a charity we consistently see the hardship of families getting the very basics like diagnosis and treatment for their Children, constantly battling for PIP, explaining how the medication has Harmed their children's health and getting the right education and social care services in place is a minefield and worrying times for all families.

This is a medication that has Harmed our Children because too many women didn't have informed choice about the dangers of Valproate in pregnancy. How the Government can say that these Children who have been impacted by a medication, that could have been prevented do not need a Redress Agency/Scheme is the biggest scandal ever, we have documents stating that they knew since 1972

OACS Charity UK encourages anyone who thinks they have a Child that's been Harmed to get in touch with us or any of the campaign groups. We need to act United Together We Are Stronger this is not the last, we'll all continue to fight for our Children's future when we are gone.

Submitted by Jo
Question about your epilepsy?

Your question will be sent to our helpline advisors.

Have a comment about this page?

All comments are reviewed by a moderator before publishing. Comments will be edited or deleted if they are offensive, libellous, slanderous, abusive, commercial or irrelevant.

We ask for your email when you make a comment through this website. This means that we can let you know directly that we have replied to you. By making a comment through the website, you allow us to use the comment in our publicity without using your name. If we would like to use your name, we will email you to get your permission.

The content of this field is kept private and will not be shown publicly.
This question is for testing whether you are a human visitor and to prevent automated spam submissions.
20 + 0 =
Solve this simple math problem and enter the result. E.g. for 1+3, enter 4.