Dáil Éireann Debate, Tuesday - 21 April 2026
184. Deputy David Cullinane asked the Minister for Health if she will review the approval process for reimbursement of orphan medicines; her plans for providing access to life changing, high cost medical products for people with rare diseases who currently cannot access medicines which have regulatory approval but do not have a reimbursement arrangement; and if she will make a statement on the matter. [28497/26]
Amharc ar fhreagraThe Government is committed to investing in medicines and supporting the development of the reimbursement system.
Budgets 2021-2025 allocated an additional €158 million for new drugs, which has facilitated the introduction of 263 new medicines, to date. 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.
Budget 2026 allocated €217 million in additional funding for drugs, with €30 million of this allocated for new drugs funding.
A central component of pharmaceutical expenditure is the HSE’s pricing and reimbursement process for medicines. 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, that has been granted European Medicines Agency (EMA) or Health Products Regulatory Authority (HPRA) authorisation, to the HSE’s Corporate Pharmaceutical Unit.
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.
There is no hierarchy of disease and pricing and reimbursement applications are considered in order of application.
There are a suite of measures, that have been implemented and are to be implemented to shorten the timeframe from the European Medicines Agency authorisation to a decision on whether to reimburse the medicine by the HSE's Senior Leadership Team.
These measures include funding by the Government to an almost doubling of capacity in the HSE’s pricing and reimbursement system with additional staff and added increased transparency through a medicines application tracker.
The State has successfully negotiated new Framework Agreements on the Supply and Pricing of Medicines with Medicines for Ireland (MFI) and the Irish Pharmaceutical Healthcare Association (IPHA). IPHA member companies will aim to shorten the timeline to submit reimbursement applications in Ireland to within six months of formal authorisation of medicines by the European Commission.
These Agreements provide commitments and a structured process towards achieving a 180-day timeline, for completing health technology assessments (HTA) and reimbursement decisions.
As part of the Agreement talks and aligned with the commitments in the Programme for Government, 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.
