Families affected by the prescribing of an epilepsy drug to pregnant women despite known risks have called on Minister for Health Stephen Donnelly to fulfill his promise to bring terms of reference to Cabinet for approval.
This comes as one family prepares for a High Court case later this month concerning the life-changing impact this drug had on their two sons. A similar case taken on behalf of Alex Fahey, 16, was settled in November last year for €12m.
The promised inquiry concerns the prescribing of a drug containing valproate used to treat epilepsy, bipolar and other conditions, sold mainly under the brand name Epilim.
An inquiry was promised by Mr Donnelly in November 2020. Months of discussion took place last year around terms of reference for this between the Department of Health and advocacy groups including OACS Ireland.
Karen Keely from OACS Ireland said: “The terms of reference for the Valproate inquiry were agreed in November 2022 albeit very reluctantly.”
She added: “Officials within the Department of Health informed OACS of their intention to bring the terms of reference to Cabinet before the Christmas recess. Our members were delighted at the prospect of the inquiry finally starting so they would receive the answers they deserve.”
The HSE previously said children exposed to this drug in the womb have a one in ten risk of developing congenital malformations and between 30% and 40% are at high risk of serious developmental disorders.
Ms Keely said delays are extremely frustrating.
“The delay in establishing an inquiry is not acceptable, and we are now calling on the Minister for Health Stephen Donnelly to provide a date on when the term of reference is going to cabinet,” she said.
“The lack of empathy and understanding from the Minister and the Department of Health is infuriating families harmed by this medication.”
The families are supported by Sinn Féin TD Rose Conway-Walsh.
“It is beyond time that the minister delivered on his promise of an inquiry into the prescribing of Epilim, it’s been over two years now and the terms of reference have been agreed,” she said.
“The minister needs to bring this to Cabinet as quickly as possible. These families have been let down, and they continue to be let down by broken promises. We need to know what people knew, when they knew it and why nobody did anything about it.”
The High Court will soon hear two more cases linked to this controversy from February 28, with the cases set to run concurrently as they are siblings.
Solicitor for the family Ciara McPhillips with Boylan Litigation Law Firm said Jack Clarke was born in 2009 and Tom Clarke was born in 2013.
“The children were born in May 2009 and September 2013 so much later than Alex Fahey, and accordingly when even more was known about the harmful effects of sodium valproate,” she said.
Ms Conway-Walsh said in relation to these cases: “People who don’t have the money (to take a case) should not be denied the truth, the truth should be available for all these families.”
A spokesman for the Department of Health said: "All documentation to progress the proposed inquiry into the historical licensing and use of Sodium Valproate in Ireland is being finalised by officials within the Department of Health.
"A memo for Government will be brought to Cabinet as soon as this work is completed."