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.
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