The Patient Safety Commissioner (PSC) has published a report calling for redress for those harmed by the epilepsy medication valproate, which causes physical and neurodevelopmental disorders in 40% of babies exposed to the drug during pregnancy.
The Hughes Report by Dr Henrietta Hughes found that there is a compelling case for the government to award those affected redress and recommends it creates a two-stage financial redress scheme – an interim scheme to enable the identification of all those harmed ensuring patients receive financial redress quickly – and a main scheme.
The Commissioner highlights an amount of £25,000 to be paid via the interim scheme, reflecting the median amount patients told the Commissioner would be appropriate. It also recommends that that the interim scheme makes its awards in 2025. The interim scheme would be followed by a main scheme award tailored to the individual harm and needs of each patient.
In addition, the report sets out the importance of providing those harmed with non-financial redress. This includes creating dedicated link works to support patients navigate complex public services; launching a housing support grant to support home adaptations; and improving the Department for Work and Pensions’ processes in terms of access to social security benefits. The report outlines the need for a new redress agency, independent of government that patients can trust to implement the proposed redress scheme.
Vital research into epilepsy drugs like valproate needed
The Epilepsy Society has warmly welcomed Dr Hughes’ recommendations but warned that research into other epilepsy medications is also vital to stop history from repeating itself with other drugs.
Clare Pelham, Chief Executive of the Epilepsy Society said: “The recommendations within the Hughes Report are frank, fair and long overdue. Redress must now follow swiftly to the timetable set by Dr Hughes. And rightly so. But the government must also take note of her call for vital research that will stop history repeating itself. We must break the endless cycle of harm followed by compensation. We cannot – and must not – go round this loop again with other epilepsy drugs that also increase the risk of harm during pregnancy.
“There must be no more babies born with disabilities that could have been avoided. Only a foolish politician would see redress for the harm caused by sodium valproate as job done.”
The Epilepsy Society praised the families who have campaigned tirelessly around sodium valproate, not only for themselves but for future generations. Since 2021, the Epilepsy Society’s Safe Mum Safe Baby campaign has been calling for the government to invest in vital genomic research that could identify which anti-seizure medications will be safer for which women during pregnancy. It would reduce the risk of babies being born with preventable disabilities. It would be a long-term legacy for women whose lives have been a campaign for justice.
According to a report from the OHE, commissioned by the Epilepsy Society, the cost of a lifetime disability for a baby harmed by epilepsy medication ranges from £2.5 million in severe cases of autism to £124,000 for a child born with Attention Deficit Hyperactivity Disorder.
“It doesn’t take a mathematical genius to work out that investment in research today would not only result in healthier outcomes for the next generation but would save the government money,” Clare Pelham added.
The Hughes Report, which also calls for redress for victims harmed by pelvic mesh, is based on in-depth interviews with harmed patients, as well as a survey of over 500 people who had either experienced negative side effects from pelvic mesh or were now raising valproate harmed children requiring additional support.
The report recommendations have been sent to the government and the PSC awaits a response.