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.

I thank the Senator for raising this issue which I am taking on behalf of the Minister for Health, Deputy Carroll MacNeill today.

It is an important topic, as the Senator said.

Duchenne muscular dystrophy is a rare disease affecting fewer than 200 people in Ireland. The Minister met with families of children with DMD in July 2025 and spoke at Muscular Dystrophy Ireland's national conference in December 2025. The State acknowledges the importance of access to medicines and is aware of the plight of patients with DMD. This Government is committed to providing timely access to new and innovative medicines. Significant investments have been made in recent years, with annual spending on medicines now more than €3 billion. This is a very welcome investment to support patients through the availability of new medicines. This investment has included dedicated funding of €158 million for new medicines from budgets 2021 to 2025. Budget 2026 allocated an additional €30 million in funding for new drugs. All this investment has allowed the HSE to approve reimbursement for 250 new medicines, or new uses for existing medicines, including 101 for treating cancer and 69 for treating rare diseases.

Givinostat, sold under the brand name Duvyzat, has recently undergone assessment by the European Medicines Agency. The EMA evaluation recommended that it be granted conditional marketing authorisation for the treatment of DMD in ambulant patients aged six years or older. The European Commission granted this conditional marketing authorisation on 6 June 2025. The HSE has statutory responsibility for decisions on pricing and reimbursement of medicines and medical items, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013. The Minister for Health met with her Italian counterpart at the Employment, Social Policy, Health and Consumer Affairs, EPSCO, Council meeting in June 2025 to ask him to encourage the developing company, Italfarmaco, to submit a timely pricing and reimbursement application to Ireland.

On 6 August 2025, an application for reimbursement was received by the HSE and underwent a rapid review by the National Centre for Pharmacoeconomics, NCPE. As I said, that happened really quickly. Following the conclusion of a rapid review on 14 August 2025, a full health technology assessment, HTA, was commissioned by the HSE on 26 August 2025. On 30 September 2025, the NCPE met with the developer to assist in the HTA process. The assessment could not continue until the NCPE received the full health technology assessment from the company, which was received on 15 January 2026. The HSE has advised that it will process and assess any pricing and reimbursement application received as efficiently as possible within the resources available to it. The HSE has also advised that the application remains under consideration and it cannot make any comment on possible outcomes from the ongoing process, but I assure the Senator it is being looked at and is a priority for the Minister.

I thank the Minister of State for being so forthright. She stated that the HSE "has also advised that the application remains under consideration and it cannot make any comment on possible outcomes from the ongoing process", so timelines are still questionable there. I fully accept assessments exist and procedures matter but, unfortunately, Duchenne muscular dystrophy does not wait for process and these children's illness does not pause while we are dealing with the paperwork. We are 18 months on from the initial assessment of this application and there is still no final timeline. Every month and every day really matters. It is shrinking windows at this stage.

Parents are not asking the Minister of State to bypass any legislation or safeguards, but they are asking her to name a timeframe indicating whether this decision is weeks away. Otherwise, they are living in complete uncertainty. Will the Minister of State make sure we commit to a clear timeline regarding givinostat?

The Senator is right. It is important we get a timeline. There have been a lot of meetings, as the Senator heard from my response. The Minister is absolutely committed. I assure the Senator she appreciates the importance of ensuring patients with Duchenne in Ireland have access to the latest treatment. As a Minister of State in the Department of Health, I am very appreciative of this too and I do understand. The HSE has sole statutory responsibility for making decisions about which medicines are reimbursed.

The Government has been committed to investing in the medicine since 2021. The HSE has approved 250 new medicines and new uses for existing medicines. Two new framework agreements, in principle, have been reached with the Irish Pharmaceutical Healthcare Association, IPHA, and Medicines For Ireland, MFI, regarding pricing and supply of medicines. As part of these agreements, the State, MFI and the IPHA have agreed to develop a future strategy partnership which will support the Department in developing a pilot early access programme focused on rare diseases, in line with commitments in the programme for Government. There are a few other rare diseases in Ireland. The Minister has committed to working on this. I thank the Senator for raising it.

I know the Minister of State is staying for the next Commencement matter. I thank her for that and for her time in the House today.