Medicinal Products Seanad Éireann — 2026-01-27 ============================================================ Aubrey McCarthy (IND), University of Dublin I thank the Minister of State for being here today. I want to mention something urgent that affects 110 children in this State and is very time-sensitive. I refer to the ongoing delay in getting access to givinostat, a treatment for Duchenne muscular dystrophy. This is not about debating the policy on how medicines are given but about the children who are being affected and their families. It is also about how the time delays are affecting those children. I was contacted by a constituent who has a child whom I will call Jack. He is 11-years-old, loves superheroes and is an ordinary little kid. He should be worrying about friends and school but at the moment he is worrying about whether his body is going to keep up. Every step he takes becomes more difficult. As the Minister of State knows, for families living with Duchenne it becomes a countdown. They do not talk about it much but it is always there. They have to think about how long a child will be able to climb the stairs or to play football. What is awful about Duchenne is that is relentlessly progressive so whatever is lost is permanently lost and cannot be regained. That is why givinostat really matters in this situation. Families know that there is no cure and are not pretending otherwise. What is important is time for children like Jack to walk that bit longer, to be independent and to have time to hold on to the ordinary moments that childhood should bring. For his parents, progress will not be measured in clinical terms but in short-term wins and how long Jack can continue playing football and climbing the stairs in the house. When Jack's mum first heard about givinostat, she did not feel false hope but she did realise that the story would not only be about loss but that something in the progression of the disease might be slowed down. The Duchenne community really hopes that givinostat, if allowed, will not be just another medicine but will actually be a lifeline for them. The Minister of State will have received all of the details regarding this particular case. The HSE has provided a response regarding its assessment and reimbursement process. I understand that there are systems and safeguards in place but what the families are struggling with is the silence. They are not hearing anything back. The reimbursement application for givinostat has been in progress since August 2024. It has been worked on and been under consideration for nearly 18 months but unfortunately there is no timeline or indication of when a decision might be made and no sense of when the end will be in sight. For the Duchenne community, the delay is what matters because every regression in the child's body is a loss that cannot be regained. They are not asking for shortcuts but are asking for clarity, honesty and for a system that understands what is actually happening regarding the children. Givinostat has already received EU conditional authorisation and is available in other jurisdictions. It is seen as a treatment that slows down the disease but in Ireland children are being left in limbo which is hard to explain to parents. Today I am asking for three things, the first of which is an acknowledgement that the lack of any clear timeline is causing real angst among families. Second, when are the HSE and the NCPE processes expected to conclude? Families deserve to know this. Finally, will the HSE be asked to prioritise and expedite the assessment of givinostat, given its regulatory status and availability elsewhere? When a treatment has already met EU standards, it is not unreasonable to expect momentum in our own jurisdiction. These families are not looking for promises. They are just looking for clarity, straight answers and transparency because time is a serious factor here. --- Source: Houses of the Oireachtas. Licensed under CC BY 4.0 (https://creativecommons.org/licenses/by/4.0/). The Official Report is revised after first publication; the fetch timestamp below identifies the version quoted. Record URI: https://data.oireachtas.ie/akn/ie/debateRecord/seanad/2026-01-27/debate/main Retrieved: 2026-08-14T04:54:33+00:00 Sitting date: 2026-01-27