Dáil Éireann Debate, Tuesday - 26 May 2026
1224. Deputy Ken O'Flynn asked the Minister for Health if the HSE maintains any target timeframe for completion of reimbursement assessments relating to treatments for progressive neurodegenerative diseases. [39069/26]
View answerThe Government is committed to investing in new medicines.
Budgets 2021-2025 allocated an additional €158 million for new drugs, which has facilitated the introduction of 263 new medicines, to date. 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.
As well as the health needs of the public, legislation requires the HSE to consider a medicine’s cost-effectiveness and budget impact when deciding if it will reimburse it. Objective, scientific methods are used to assess these factors alongside input from patients.
The HSE’s Drugs Group—its national expert committee, including public interest members—will consider all evidence and issue a recommendation to the HSE Senior Leadership Team, which holds final decision-making authority on the reimbursement of a medicine.
There is a suite of measures, that have been implemented and are to be implemented to shorten the timeframe from the issue of a Marketing Authorisation on foot of a positive opinion by the European Medicines Agency to a decision on whether to reimburse the medicine by the HSE's Senior Leadership Team.
Included among these measures are new Framework Agreements on the Supply and Pricing of Medicines with Medicines for Ireland (MFI) and the Irish Pharmaceutical Healthcare Association (IPHA) which provide commitments towards achieving a 180-day timeline for completing health technology assessments (HTA) and reimbursement decisions following application by the Marketing Authorisation Holder. The Agreements outline a structured process towards achieving the 180-day timeline for reimbursement decisions by Q1 2029, accelerating patient access to new treatments
