Epilim inquiry to move forward

A non-statutory inquiry into the historical licensing and use of sodium valproate (Epilim) in women of child-bearing potential is moving forward, the government has said.

Health minister Stephen Donnelly said he had secured government approval to progress the inquiry he first announced nearly three years ago.

Ciara McPhillips, partner at specialist litigation firm Michael Boylan LLP, told Irish Legal News that “some momentum” is now necessary.

Read our Sodium Valproate Scandal news article.

Medicines containing valproate can cause birth defects and developmental disorders in children whose mothers take such medicines during pregnancy. Around 1,200 children in Ireland have been affected by in utero exposure to Epilim.

The inquiry will “provide a voice to persons with a diagnosis of foetal valproate spectrum disorder (FVS), their mothers and other family members” and will “seek to document the evolution of sodium valproate regulation and the practices around the control of this product”.

The chair of the inquiry will also be tasked with “assessing the health service’s current capacity to respond to safety issues relating to use of anti-seizure medications in women of child-bearing potential”.

Mr Donnelly said: “Today I was delighted to secure government approval for the establishment of an inquiry which will examine the licensing and use of sodium valproate in women of child-bearing potential in the State.

“When I met with the patient groups involved with this issue, I supported their call for an inquiry, and I am very pleased to be able to progress this. This inquiry will be designed to give a voice to patients and their families while looking at the use of sodium valproate in Ireland since it was first licensed.

“There is work to be done before the non-statutory inquiry can commence, but this is an important milestone, and my officials will now work to bring this forward.”

He added: “Sodium valproate continues to be an essential part of the treatment plan for some patients and is an effective medication. It is important that people who are currently taking sodium valproate do not make any changes to their treatment without discussing any concerns they have with their doctor in the first instance.”

Ms McPhillips, whose firm has represented a number of people affected by in utero exposure to Epilim, said: “Whilst I welcome confirmation that the terms of reference have been approved by Cabinet, I share the Organisation for Anti-Convulsant Syndrome’s disappointment that it is not a statutory inquiry.

“But moreover I would like to see some momentum from this point onwards as there is much to do — the inquiry itself but also thereafter in terms of providing for those affected. Given that children have been exposed since 1975, too much time has already passed.

“In the meantime, we will continue to bring cases before the Courts and work with experts in this field right across Europe to ensure redress.”

Irish Legal News, July 2023