Healthcare Policy
Seanad Éireann — 2026-06-10
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Jennifer Murnane O'Connor (FF), Carlow-Kilkenny

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.

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Record URI: https://data.oireachtas.ie/akn/ie/debateRecord/seanad/2026-06-10/debate/main
Retrieved: 2026-08-14T04:55:02+00:00
Sitting date: 2026-06-10