Dáil Éireann Debate, Thursday - 7 May 2026
534. Deputy Ken O'Flynn asked the Minister for Health whether her Department maintains any central record, oversight mechanism, or reporting framework in respect of reimbursement applications for high-cost or rare disease medicines, including orphan drugs; and if not, how the Department exercises policy oversight of access to such medicines. [33750/26]
View answer535. Deputy Ken O'Flynn asked the Minister for Health whether any formal escalation, prioritisation, or exceptional review mechanism exists within the HSE or under her Department’s policy remit for reimbursement applications relating to rare or progressive neurological conditions, including Friedreich’s ataxia; and if she will detail the criteria and governance of any such mechanism. [33751/26]
View answer537. Deputy Ken O'Flynn asked the Minister for Health whether she considers it appropriate that no prioritisation framework exists within the State’s reimbursement system for life-limiting or progressive rare diseases; and whether any review of this policy position is underway.; and if she will make a statement on the matter. [33753/26]
View answerI propose to take Questions Nos. 534, 535 and 537 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 date72 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.
This level of investment is unprecedented in supporting patients through the availability of new and innovative medicines.
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.
There are formal processes which govern applications for the pricing and reimbursement of medicines, and new uses of existing medicines, to be funded and /or reimbursed. The HSE is the statutory decision maker for the pricing and reimbursement of new medicines under the Health (Pricing and Supply of Medical Goods) Act 2013. The HSE considers the criteria set out in the Act. The Minister for Health 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 begin the pricing and reimbursement process for a specific use (indication) of a medicine, the marketing authorisation holder (MAH) must submit an application to the HSE. A medicine must be licensed by the European Medicines Agency (EMA) or the Health Products Regulatory Authority (HPRA) for an application to be made to the HSE.
The MAH must continue to engage throughout the process with the HSE.
The HSE robustly assesses each application for pricing/reimbursement on objective, scientific, and economic grounds, and on the advice of the National Centre for Pharmacoeconomics to ensure that it can make more medicines available to Irish patients. This ensures that the right medicines are chosen, and approval is at a sustainable price.
