Dáil Éireann Debate, Tuesday - 19 May 2026
1102. Deputy Michael Cahill asked the Minister for Health to urgently address issues raised in correspondence (details supplied) and ensure that the access to medicines for those with rare diseases will never be an issue for families; and if she will make a statement on the matter. [37032/26]
View answerThe State recognises the importance of timely access to innovative medicines for patients in Ireland.
Budgets 2021-2025 allocated an additional €158 million for new drugs, which has facilitated the introduction of 263 new medicines. 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.
The Department has reached out to the HSE in relation to this matter.
The HSE has advised that it robustly assesses applications for pricing and reimbursement to make sure that it can stretch available resources as far as possible and to deliver the best value in relation to each medicine and ultimately more medicines to Irish citizens and patients.
HSE decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds.
Regarding pegvaliase (Palynziq®), the HSE have advised that they received communication on the 11th December 2025 from BioMarin (the applicant) notifying the CPU of BioMarin’s intention not to appeal the HSE’s proposed decision not to reimburse pegvaliase (Palynziq®) for the treatment of patients with phenylketonuria (PKU) aged 16 years and older who have inadequate blood phenylalanine control (blood phenylalanine levels greater than 600 micromol/l) despite prior management with available treatment options.
The HSE advise that the pricing and reimbursement application is now closed based on the correspondence received from BioMarin. The HSE will consider further offers from BioMarin, in line with the Health (Pricing and Supply of Medical Goods) Act 2013, should BioMarin wish to reapply for reimbursement for pegvaliase (Palynziq®).
