30-05-2025
Calls for inquiry into prescribing of anti-epilepsy drug to begin
The Minister for Health has been urged to commence a long-awaited inquiry into the historical prescribing of an anti-epilepsy drug to pregnant women without delay.
Families affected by sodium valproate, which can cause serious birth defects and development disorders, were told last year that the inquiry would begin 'within weeks'.
However, despite a chairperson being appointed last June, the inquiry has yet to start.
Karen Keely, from the Organisation for Anticonvulsant Syndromes Ireland, has said she is "dumbfounded and absolutely shocked" over the delay.
All of Ms Keely's three sons - 38-year-old Harry, Lee who is 29, and 26-year-old Lorcan - have been impacted and require round-the-clock care.
Speaking from her home in Ratoath, Co Meath, she said she has been fighting for an inquiry for almost a decade and thought it would be halfway through by now.
"I'm gutted... there's no words for how I feel, because you know you're living with a guilt knowing what you know, and you're still fighting for something," she said.
According to the Department of Health, prior to the formal commencement of the inquiry, "it is necessary to have in place regulations made under the Data Protection Act 2018".
This, it said, is necessary to ensure that the inquiry has a "robust legal basis" and to support its data protection obligations.
However, Ms Keely said the delay is unacceptable.
"The only thing that's holding up in this inquiry is the data regulations. And it does not take a year to put data regulations in place. It doesn't take a year," she said.
"I hope that the data regulations are put in place as soon as possible. I hope the inquiry is started, like yesterday. It needs to start. The Irish voices literally need to be heard. They're the only voices that have not been heard."
The Department has previously stated that the non-statutory inquiry will document the evolution of sodium valproate regulation, the practices and controls in relation to its prescribing, and the timeline of developments in scientific knowledge about the potential impact of the drug on foetal development.
It's also said that sodium valproate is an effective medication and continues to be an essential part of treatment plans and that patients shouldn't make changes to their treatment without first consulting their doctor.
However, it is estimated over 1,000 children have been impacted since the 1970s, with the most recent cases dating to the 2010s.
Solicitor Ciara McPhillips represents many of the families and said it is been an incredibly upsetting time for them.
"We understand the reason for that is that data protection regulations, which are obviously important to the inquiry, which will deal with personal data, have not been finalise. Families are very frustrated and feel that last year was a false dawn."
She said the timeline set out by the then minister for health, Stephen Donnelly, last June was "overly optimistic", but said regardless of that, "it's incredibly frustrating for families who have campaigned for this for years and who have children who are very much affected by this in a life-altering way".
"Behind all of that is a deep concern for what will happen to their children when they're no longer here and perhaps no longer able to continue the fight on their behalf," she said.
Ms Keely said it is imperative that the necessary data regulations are put in place, and the inquiry starts as soon as possible.
"I want to know who knew what and when. I want people accountable for their actions, and be responsible for their actions," she said.
She also wants more than the facts established.
"Redress and an apology. I should have got the apology years ago," she said, before outlining the care her three sons require and the toll it has taken on her.
"I've been doing this since I'm 18 years of age. I've been going to medical appointments, physios, speech, surgeries for every single thing you can think of.
"When they come home for the surgeries, you have to really look after them. Then you have the incontinence you have to look after … and I have one child also who's going through his own issues and he's been put on antidepressants for them."
"It's so draining they need constant care. You know, it's 24 hours. There's no stop. There's no stop button on this," she said.
Any free time she gets, she pours into campaigning to get the inquiry up and running.
In a statement, the Department of Health said since the appointment of Bríd O'Flaherty as chair, "significant work has been carried out to put in place the necessary arrangements to operationalise and establish the inquiry".
It said the necessary data regulations are currently being drafted and that when they are finalised, it is anticipated that "the public facing elements of the inquiry will commence shortly thereafter".
Ms Keely's message to the Minister is simple: "You need to get this inquiry up and running, you need to get this sorted."
