Medicinal Products Dail Éireann — 2026-06-17 ============================================================ Jennifer Carroll MacNeill (FG), Dún Laoghaire I thank Deputy Ward for raising this issue. This is something I have been working on with families for over a year now, since this drug was approved by the European Medicines Agency. I have met many of those families. I met them when they were here last week, before they had their audiovisual room briefing, I have met them four, five or six times online and I met them past year in person - I have met them so many different times. Together, we have been working to try to get this drug approved within the Irish system. As the Deputy will be aware, when a drug is approved at a European Medicines Agency level, it does not necessarily mean that it will be available in Ireland. Why? It is because it is necessary for the drugs company to make an application to have the drug available in Ireland. It is not as though Ireland simply gets it as a matter of course. The HSE needs an application to be made. The drug company has to choose to want to sell it here. We have been trying to encourage Italco Pharma for some time to make the appropriate application. The drug was approved in June of last year. I immediately met families in relation to the next steps. We did not get an application from the maker of givinostat for some time, so we all engaged in a lobbying campaign in different ways. I met the Italian health minister, Mr. Schillaci, in Luxembourg to encourage him to ask the company to make an application in Ireland. I made the same ask of him again at a later stage, in November, in South Africa, at the G20 meeting. The Taoiseach has been involved in this, asking Prime Minister Meloni to get involved to ask the Italian pharmaceutical company to make the appropriate, complete application here in order that the HSE could respond. I was on my summer holidays in August of last year waiting to see every day with the HSE whether the application had been made. Eventually, on 6 August, the health technology assessment, HTA, application was first made. I thank Michael Barry and the people in the HSE for the speed with which they processed that part of the application, which was exceptionally quick. The National Centre for Pharmacoeconomics did a rapid review. The application was made on 6 August, the rapid review was completed on 14 August and a full HTA commissioned on 26 August. That is unprecedentedly fast, and I am very grateful to the HSE for its speed, reflecting the seriousness of this. On 30 September the HSE met with Italco Pharma to assess the HTA process. The assessment of the pricing and reimbursement application could not proceed until the full HTA was received from the Italian company. That was eventually received on 15 January 2026. We were updating the families at every stage, discussing and giving them full information and transparency as to what was happening. I am grateful to the HSE for concluding the assessment on 3 March, which was a matter of 26 days or so. That was very fast. The HSE's corporate pharmaceutical element, which is the interface between the HSE and the pharmaceutical industry, held a meeting with Italfarmaco on 27 March 2026. A commercial offer was received from Italfarmaco on 8 May 2026. Again, we were waiting for these applications to be made. The HSE drugs group continued that application at a meeting one month later on 9 June. When we bring together all of the different experts, it is not something that is stood up quickly. We have to review the documentation and have the scientific experts there. The drugs group supported the reimbursement of givinostat. Yesterday, the senior leadership team in the HSE supported that application and the drug will now proceed through a managed access protocol. We have discussed in detail with the families how a managed access protocol works. It is a matter of clinical decision making as to who gets the drug. Of course, as the Deputy has referenced, not every boy is suitable for it. The question of being ambulatory, being able to stand and all of those things are not decisions for the Deputy and I but are decisions for clinicians. We want to make that drug as broadly available as possible but, ultimately, it is a clinical decision as to who should get the drug and who should not. I am so thankful to the HSE and thankful to the families for their constant engagement with me in relation to this, not just in our constituency, but around the country. --- 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/dail/2026-06-17/debate/main Retrieved: 2026-09-21T01:01:09+00:00 Sitting date: 2026-06-17