Commercial negotiations have begun between the HSE and the manufacturer of a drug for children with Duchenne muscular dystrophy, the Dáil has heard.
Confidential talks are now underway between the HSE’s Corporate Pharmaceutical Unit and Italfarmaco, the company behind Givinostat.
The update came after Donegal Deputies Pearse Doherty and Pat the Cope Gallagher raised the cases of two Donegal families who are among 100 children in Ireland urgently seeking access to the treatment.
Deputy Doherty told the Dáil that children with DMD are “in a race against time” because Givinostat is only available to children who still have mobility.
The matter is particularly urgent for nine-year-old Aaron Langan from Laghey, whose family fear that if his mobility is further affected by the condition, he may not be able to access the treatment even if it is approved for reimbursement.
Deputy Doherty and Gallagher also raised the case of 10-year-old Diarmuid O’Sullivan from Ballybofey, whose older brother Nathan has the same condition and has had access to the drug through a UK trial for more than 10 years.
Nathan is now an adult, and Deputy Gallagher said the treatment had allowed him to live a full life, work with the local GAA as a statistician and have his own car.
However, Diarmuid has not been able to access the same treatment.
Deputy Doherty said Diarmuid’s mother had spoken to him about the distress of caring for two sons with the same condition, while only one has access to the drug.
He quoted her as saying: “Diarmuid is approaching the age where he is likely to lose mobility.
“Imagine, as a mother, opening the fridge every day and giving my eldest boy this life-changing medicine and not giving it to my other little boy. Imagine the turmoil that causes me day after day.”
Givinostat sold under the brand name Duvyzat, has been approved in Europe for the treatment of Duchenne muscular dystrophy, known as DMD, in ambulant patients aged six years and older.
You may also be interested in
This means that children have to have mobility for the drug to be administered.
“So the clock is ticking and it is vitally important that a positive decision is taken as soon as possible and that the provision of the drug is made available,” said Deputy Doherty.
Pat the Cope said the cost of the drug should not stand in the way of treatment for children.
“We know the cost of it may seem rather high, but we cannot put a cost on the life of a child,” he said.
“They are suffering and the families are suffering. There is a mental torture to this. It is 24 hours a day, seven days a week, 365 days of the year while they care for these children.”
Deputy Gallagher added that it was difficult to understand why children in Donegal were still waiting while children across the border had access to the treatment.
Speaking on behalf of the Minister for Health Jennifer Carroll MacNeill, Minister of State Mary Butler said the HSE had received a commercial offer from Italfarmaco on Friday, 8th May, and that the application was now “getting the very best attention”.
A full health technology assessment was commissioned by the HSE on 26th August 2025, but Minister Butler said the assessment could not proceed until the National Centre for Pharmacoeconomics received the full health technology assessment from the company on 15th January 2026.
She said Minister Carroll MacNeill had engaged with representative groups and parents of children with the condition several times over the past year and would meet patient groups again this week.
Minister Butler said she understood the concerns raised by the Donegal TDs.
“What I do know is that there are children who need this drug,” she said.
“I agree with both of you that there should not be a situation where one child is living in Donegal and another child is living five miles down the road and has access to the drug. We get that.
“It is really important now that we get the negotiations under way and that we get a positive result.”
