I want to speak about givinostat and the current status of efforts to have this medication made available to the boys in Ireland who are living with Duchenne muscular dystrophy, DMD.

I will outline the timeline and where the process now stands. On 11 June 2025, I stood alongside parents of families at a demonstration outside Leinster House and we held a briefing in the audiovisual room to raise awareness of DMD. What politicians learned that day is that DMD is the most common and one of the most severe genetic conditions diagnosed in early childhood. It almost always affects boys. Around one is every 3,500 baby boys worldwide is born with the condition. In Ireland, approximately 110 people are known to be living with DMD, the majority of whom are children. Children with DMD can struggle to walk, run, stand up and climb stairs. Many boys will need a wheelchair by around the age of 12. As the disease progresses, it affects the spine, the heart and the lungs. By their mid-teens, some boys develop serious heart disease and by their late teens or early 20s, many begin to experience breathing problems. Even with modern medical care, most people with DMD will die from heart or respiratory failure before or during their 30s.

For families, this is a devastating and relentless condition but there is hope. A medicine called givinostat is a game-changer. It halts the progression of DMD, giving the boys more time on their feet and a better quality of life. Yesterday, I was informed that the health technology assessment has been completed by the National Centre for Pharmacoeconomics, NCPE, and that its recommendation is that givinostat should not be considered for reimbursement unless its cost-effectiveness can be improved. I will not lie; my heart dropped. I know this is worrying for families but it is not an unusual decision when it comes to medicines for rare and severe conditions.

The next step is for the NCPE report to be considered by the HSE when it makes its reimbursement decision in line with the Health Act. The process now moves into the HSE drugs decision system, where price negotiations can take place and where, more importantly, broader factors can still be considered. The broader factors include the severity of DMD, the lack of alternative treatments and the enormous impact of this condition on children, their families and the wider community. I ask that every possible effort is made to progress these negotiations urgently and to ensure that cost does not become the only factor in a decision about a life-limiting childhood condition. These boys and their families have waited long enough; they deserve urgency. Time is muscle and every day that passes, these boys deteriorate. They need access to medication, like children in other European countries with early access programmes and compassionate access, such as Belgium, France, the UK, Germany, Italy, the Netherlands and Spain. I want the same for Ireland.