Devolved nations press UK for support for victims of epilepsy drug valproate

The three devolved governments have written to the UK Government urging it to set out how it will help people harmed by an epilepsy medicine taken during pregnancy.

Health ministers in Scotland, Wales and Northern Ireland warned UK public health and patient safety minister Dame Diana Johnson that a lack of action was “causing significant anxiety and distress” for patients across the four nations

Thousands of babies are thought to have been harmed during pregnancies since the 1970s by sodium valproate, a drug used to treat epilepsy and bipolar disorder which is now known to cause major birth defects and lifelong learning difficulties.

A report on the issue by Dr Henrietta Hughes, the patient safety commissioner for England, was published in 2024 but has not received a response from the UK Government.

In a joint letter to Dame Diana, Scotland’s public health minister Maree Todd, Welsh Government cabinet minister for health Mabon ap Gwynfor, and minister for health for Northern Ireland Robbie Butler urged the UK Government to act.

They wrote: “The continued absence of a formal response is causing significant anxiety and distress for affected individuals and families across all parts of the United Kingdom.

“Those impacted by the issues considered in the Hughes Report have already waited many years for recognition and resolution, and the lack of clarity regarding the UK Government’s intentions is adding to that uncertainty.”

The ministers said they were “concerned” that the UK Government had not decided whether to financially compensate patients impacted by the medicine, adding that Westminster had offered no timescale for a decision.

The devolved ministers welcomed the UK Government’s commitment to work with them and said they “stand ready to consider any proposals”.

The letter added: “Given the length of time since the publication of the report, we believe it is now imperative that the UK Government provides clarity on its intentions. We therefore ask that you set out, at the earliest opportunity, the UK Government’s proposed approach to responding in full to the Hughes Report.

“Those affected have waited far too long for certainty and deserve a clear understanding of the next steps.

“We would welcome your urgent attention to this matter and look forward to an early response.”

Ms Todd added: “I fully recognise the profound and lasting impact that sodium valproate has had on affected individuals and families, all of whom have lived with its consequences for many years.

“The continued absence of a response to the Hughes Report from the UK Government is causing significant anxiety and distress for those seeking clarity about what happens next. People affected have already waited far too long for certainty.

“I have written jointly with ministers in Wales and Northern Ireland calling on the UK Government to publish its response and set out the next steps for those affected.”

A spokesperson for the Welsh Government said: “We recognise the profound and lasting impact on individuals and families affected by the issues raised in the Hughes Report.

“In partnership with health ministers across the devolved nations, the cabinet minister for health and care has called on the UK Government to respond formally to the Hughes Report at its earliest opportunity.

“For far too long those harmed and their families have been without an answer from the UK Government. It is an answer only Westminster can give because regulation of medicines and medical devices, including sodium valproate and pelvic mesh, is reserved to the UK Government.”

The health minister for North Ireland Robbie Butler said: “Those who have been harmed by sodium valproate have had to wait too long for a formal response to the recommendations in the Hughes Report.

“This has been stressed on many occasions in meetings with colleagues from across the UK.

“Unfortunately, as the regulation of Medicines and Medical Devices sits with Westminster, none of the devolved administrations can move forward until there is a response from the UK Government.”

Mr Butler said the devolved nations believe it is “imperative” that the UK Government provides clarity on its intentions.

“I fully acknowledge the stress and challenges experienced by the affected families and it is paramount that collectively we remain focused on supporting them,” he said.

“They have waited far too long for certainty and deserve to have a clear understanding of the next steps.”

In a speech to the House of Commons on October 29, the UK health minister said the Government “knows that the lives of women, children and their families have been profoundly changed”.

“Their voices must be heard as we address these issues with the urgency demanded,” Dame Diana said.

“We are determined to build a system that listens, that hears and that will act, and we need to do that with speed, compassion and proportionality.

She added: “The support we offer to those who have suffered profound harm must be meaningful and responsive to their needs. The Government are clear that those affected have already waited far too long for answers.

“While a decision has not yet been taken to provide financial redress, my priority is to drive these discussions forward with greater urgency, while ensuring that any decisions we take are underpinned by a thorough assessment of the available options, with continued engagement across Government.”

Dame Diana said she “understands and appreciates” the frustration as it has been two years since the report was published, and she made assurances that she will do her very best to make progress on redress and all of the recommendations in the Hughes report.