The parents of a child with a rare muscular disease are urging that the State does "not delay any longer" in making decisions on access to a drug that has been approved for use in Europe but has not been approved for reimbursement in Ireland.
A public assembly is planned for Donegal town this evening in support of nine-year-old Aaron Langan and other children with Duchenne Muscular Dystrophy who are seeking access to the drug Givinostat.
Givinostat, which slows the progression of the disease, was approved for use in the European Union by the European Medicines Agency in June 2025.
The muscular disease that gradually causes weakness and loss of muscle function affects fewer than 200 people in Ireland.
St Eunan's National School in Laghey, where Aaron is a pupil, has organised an event to raise awareness of the challenges facing children with Duchenne Muscular Dystrophy.
Parents Sinead and Dermot Langan are urging the Government to secure access to the drug in the hope that it may help their son as well as other children.
"Givinostat is a drug that has proven to slow the progression down. While it is not a cure it would give our boys a better quality of life for longer and prolong muscle function in the body," they said.
They told RTÉ News that their son is currently in a wheelchair and needs "a lot of day-to-day care to do the normal stuff that we take for granted".
They described him as a very social "happy go lucky child who loves music, cars and tractors" with a great sense of humour and who "faces every day with great courage".
Last June, Sinead and Dermot Langan were among a delegation of parents, whose children have DMD, that travelled to Leinster House to highlight their case.
They said the DMD community has been trying ever since to keep the pressure on the Government and HSE to fast track the process of getting the drug.
The parents said they are calling on the Government to "not delay any longer in the decision in passing this drug and get it rolled out" as they stress "time is muscle" for affected children.
"We feel let down and that a year later we still have no decision and have lost a year of time and muscle which is irreversible.
"Any more delays would be devastating for our DMD community. This is totally unacceptable and our children deserve better," they said.
The Donegal parents are also advocating that the Government adopt a similar definition of ambulatory as that of the UK.
The matter has been raised in the Dáil and the Seanad in recent weeks by public representatives, who have called for access to the drug that is available in the UK.
A Department of Health spokesperson said Minister for Health Jennifer Carroll MacNeill "is acutely aware of the plight of individuals with DMD".
They said Minister MacNeill met with families of DMD last week, and she will continue to engage with families and individuals impacted by the disease.
They said the department has been closely following the pricing and reimbursement process for Givinostat (also known as Duvyzat) for the treatment of ambulant DMD patients aged six and over.
They confirmed that the Health Service Executive received a commercial proposal from Italfarmaco, the marketing authorisation holder for Givinostat, on 8 May 2026.
The department spokesperson said the next steps involve the HSE Corporate Pharmaceutical Unit entering confidential commercial negotiations.
These negotiations with the manufacturer will determine whether a cost-effective pricing agreement can be reached.
The HSE Drugs Group, a national committee that makes recommendations on the pricing and reimbursement of medicines, will then consider the matter.
That group will review Pharmacoeconomic reports along with the outcome from commercial negotiations and any submissions from patient groups.
They then consider all of the evidence and make a recommendation to the HSE Senior Leadership Team, who has the statutory authority for decisions on the pricing and reimbursement of medicines.
Meanwhile, a spokesperson for Italfarmaco, the company that produces the drug Givinosat, said it is in active communication with the HSE regarding access for patients in Ireland.
Italfarmaco's spokesperson continued: "As these discussions are ongoing, the company is unable to provide further details at this time."
The Department of Health spokesperson said it is committed to furthering the Programme for Government's work in access to medicines.
