Medicinal Products
Seanad Éireann — 2026-01-27
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Jennifer Murnane O'Connor (FF), Carlow-Kilkenny

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.

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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