Dáil Éireann Debate, Thursday - 21 May 2026
323. Deputy Mark Ward asked the Minister for Health if she will consider running a pilot orphan drug early-access programme in order that children with Duchenne muscular dystrophy can access givinostat; if a pricing and reimbursement application is being progressed by the HSE for givinostat; and if she will make a statement on the matter. [38448/26]
Amharc ar fhreagra324. Deputy Mark Ward asked the Minister for Health if givinostat will be made available for children with Duchenne muscular dystrophy; and if she will make a statement on the matter. [38449/26]
Amharc ar fhreagraI propose to take Questions Nos. 323 and 324 together.
The State recognises the importance of timely access to innovative medicines for patients in Ireland, particularly patients with rare diseases.
Budgets 2021-2025 allocated an additional €158 million for new drugs, which has facilitated the introduction of 263 new medicines, to date,72 of these new medicines were for rare diseases. Budget 2026 allocated €30 million of funding available for new drugs to be allocated from the overall additional €217 million in funding allocated for medicines.
The Year 1 cost of a new drug comes from the allocation for new medicines, but it should be noted that once these medicines are approved for reimbursement the full cost of providing them can reach multiples of this initial cost as their uptake increases.
Ireland is among the highest spenders on health across the EU (OECD), with the third-highest rate of State coverage of pharmaceutical expenditure in Europe.
Under the Health (Pricing and Supply of Medical Goods) Act 2013, the HSE has statutory responsibility for decisions on the pricing and reimbursement of medicines and medical devices. The Minister has no role in decisions on pricing and reimbursement.
There is no hierarchy of disease and pricing and reimbursement applications are considered in order of application.
To commence the pricing and reimbursement process, a pharmaceutical company must submit an application for a new medicine or a new use of an existing medicine to the HSE’s Corporate Pharmaceutical Unit. European Medicines Agency (EMA) or Health Products Regulatory Authority (HPRA) authorisation is required for the medicine prior to submission to the HSE for reimbursement as reimbursement only applies to licensed uses (indications) of the medicine.
Applicants must continue to engage through-out the process to ensure that the necessary evidence is available for the HSE to carry out its statutory role as a decision-maker with respect to the reimbursement of new medicines, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013.
With respect to Givinostat, the HSE received a commercial proposal from Italfarmaco, the marketing authorisation holder for Givinostat on 08 May 2026.
This application remains under consideration with the HSE. The HSE cannot make any comment on possible outcomes from the ongoing process.
The Programme for Government contains a commitment to examine the development of early access schemes for rare diseases.
The State and the pharmaceutical sector have agreed to establish a strategic partnership on the development of a sandboxed early access programme for rare diseases. This will be a proof-of-concept initiative, aligned with the commitments in the Programme for Government and recommendations in the National Rare Disease Strategy 2025–2030.
