I welcome the Minister of State, Deputy Murnane O'Connor, to the House. She is most welcome to Seanad Éireann.

I thank the Minister of State for coming in. Since I became a Senator 16 months ago, I have raised the issue of givinostat for children living with Duchenne muscular dystrophy, DMD, so many times, together with other colleagues in the Seanad. Last month, a large crowd of up to 2,000 people turned out in the Diamond in Donegal to support the children with DMD. In the health committee last year, we were told it would be sorted by Christmas. It was then pushed out to the early new year. Now, we are into June. Time is muscle for children with DMD. Every day, week and month that passes without access to this treatment can result in further decreased progression and permanent loss of physical ability. We are letting our children down. Families have watched as their children lose strength, mobility and independence. Children who were eligible for the treatment when givinostat was established over ten years ago in other countries are now maybe not eligible for givinostat because it has taken so long in this country. While families recognise the appropriate assessment procedures have to be followed, families are waiting and watching their children decline rapidly.

I am asking the Minister of State to outline the current status of givinostat, the timeline and when the final decision on this medicine will be made. These children have waited long enough. Time is muscle. It is important. I know of three children in Donegal with this. It is so sad to see them. I thought we would have this sorted long ago. It seems to have dragged on and on. As I said earlier, time is muscle. It is very important for these children all over Ireland. Of the three children in Donegal. One of them, Nathan, got a trial from England ten years ago. He is holding his own and is in good health. His brother, Dermot, however, does not have access to givinostat. This is something we need. Aaron Langan is the same. We need to get this sorted. We need to get it sorted soon.

The Minister of State is very welcome. I will follow on from where Senator Boyle left off. I have raised this too. I am on the health committee as well. On 15 October 2025, the governing body that decides what medicines are included in the long-term illness book stated it was at a very advanced stage and that it has been sorted. As Senator Boyle said, it was meant to be Christmas and then it was pushed out. Now we are in June and there has been no decision. I understand a meeting will be held today where they will look at it but I too know of families that have been affected by this. One of my neighbour's grandson is one of the children affected. It is a very trying time for families. As Senator Boyle said, time is muscle. The longer it goes on, the more debilitating that it is for these children. That causes stress and strain within families as well. This needs to be sorted out. I want a timeline. I want to know when families will be reimbursed for the drugs for this serious illness. I know a huge number of people are not affected by this but nobody should have to wait for the timeframe that they have had to thus far for this decision to be made.

I thank the two Senators for raising this serious issue today. As Senators know, I will be taking this behalf of the Minister for Health, Deputy Jennifer Carroll MacNeill.

Duchenne muscular dystrophy is a rare disease affecting fewer than 200 people in Ireland. The Minister spoke at Muscular Dystrophy Ireland’s national conference in December 2025 and met the families of children with DMD two weeks ago. The State acknowledges the importance of access to medicines. This Government is committed to providing timely access to new and innovative medicines and has made considerable investments in recent years, with annual expenditure on medicines now almost €4 billion.

This represents nearly €1 in every €8 of public funding being spent on health. This level of investment is unprecedented in supporting patients through the availability of new innovative medicines. Budgets 2021 to 2025 have included dedicated funding for new medicines of €158 million. Budget 2026 allocated an additional €30 million of funding for new drugs out of €217 million in additional funding for these drugs. This has enabled the HSE to approve reimbursement for 270 new medicines or new uses for existing medicines, including over 100 for treating cancer and 74 for treating rare diseases. Givinostat was evaluated by the European Medicines Agency with a recommendation that it be granted conditional marketing authorisation for the treatment of Duchenne muscular dystrophy in ambulant patients aged six years or older. The European Commission granted conditional marketing authorisation in this indication on 6 June 2025. This has been worked on.

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. In line with the Act, a company must submit an application to the HSE to have a new medicine added to the formal reimbursement list. The Minister met her Italian counterpart at the EPSCO Council meeting in June 2025 in Luxembourg to ask him to encourage the company 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. 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 Italfarmaco to assist the HTA process. The assessment of the pricing and reimbursement application for givinostat could not proceed until the full health technology assessment was received from the company on 15 January 2026. The NCPE assessment concluded on 3 March 2026. The HSE’s corporate pharmaceutical unit, the interface between the HSE and the pharmaceutical industry, held a meeting with the manufacturer on 27 March 2026. A commercial offer from Italfarmaco was then submitted to the HSE on 8 May 2026. The drugs group has met to consider the application. The HSE’s drugs group will now issue a recommendation to the HSE senior leadership team, which holds full decision-making authority on the reimbursement of a medicine. There is a lot of work ongoing. It is important, as the Senator said, that this is worked on as soon as possible. There has been a lot of engagement on this matter.

I thank the Minister of State and the Minister for Health. I know she put a lot of work into this because the Italian company really did not want to talk to us at the start and she reached out to it. We all know the assessment has to be done. I am glad that the drugs group met yesterday but it is crucial we get this medicine over the line for these children. There is one child in Donegal, Nathan, getting it across the Border, where Dermot cannot get it. This is totally wrong. We need to get this sorted as soon as possible.

I thank the Minister of State for her reply and I understand all the work that has in. It is over a year since the European drugs agency approved givinostat. I know the Minister has been negotiating with the Italian company but this has to happen sooner rather than later. There are over 200 families awaiting this news. It is a crucial time. I hope there will be a good result in the next couple of days.

I thank the Senators for highlighting this. As I said, the Minister for Health has been working and engaging with the HSE and the Departments on this. I assure them of the importance of this for patients with DMD in Ireland. It is important for families. It affects everyone. The HSE has sole statutory responsibility for making decisions on which medicines are reimbursed. The HSE continues to process and assess pricing reimbursements in applications received from a company as efficiently as possible within the resources available to it. The application remains under consideration and the HSE cannot make any commitment or possible outcomes from the outgoing process. Meetings are going on. The latest update on the process can be found on the HSE medicines tracker and on the NCPE website.

As I outlined earlier, this Government is committed to investing in medicines. Since 2021, the HSE has approved 270 new medicines or new use of existing medicines for reimbursement. The two new framework agreements have been reached with the Irish Pharmaceutical Healthcare Association and Medicines for Ireland on the price and supply of medicines. It will make a difference. As part of these agreements, the State, MFI and IPHA have agreed to develop a future strategic partnership which will support the Department of Health in its development of a pilot early access programme focused on rare diseases in line with commitments in the programme for Government.

I was recently in Brussels and we spoke about rare diseases. As the Minister and other Ministers have said, Ireland is always open for business. Once a drug is granted marketing authorisation, we strongly encourage all pharmaceutical companies to apply for reimbursement here in Ireland and to submit fully prepared HTA dossiers in a timely fashion. That is what we need to get out there. We are always open and we want that to happen.