Dáil Éireann Debate, Tuesday - 3 March 2026
918. Deputy Ken O'Flynn asked the Minister for Health in light of Rare Disease Day taking place on 28 February, if she will commit to introducing an early access scheme in Ireland for people living with rare diseases to access EMA-approved orphan medicines; if such an early access scheme will include orphan medicines products licenced for non-oncology conditions; and if she will make a statement on the matter. [16944/26]
Amharc ar fhreagra921. Deputy John Paul O'Shea asked the Minister for Health in light of Rare Disease Day taking place on 28 February, if she will commit to introducing an early access scheme in Ireland for people living with rare diseases to access EMA-approved orphan medicines; if such an early access scheme will include orphan medicines products licenced for non-oncology conditions; and if she will make a statement on the matter. [16949/26]
Amharc ar fhreagraI propose to take Questions Nos. 918 and 921 together.
I recognise the importance of timely access for patients to new medicines and supporting those living with rare diseases in Ireland. The Government is committed to investing in new medicines for patients, which has facilitated the introduction of 250 new medicines including 69 for rare diseases. For 2026, over €200m is available for medicines including €30 million for new medicines.
The State has successfully negotiated new Framework Agreements in principle with Medicines for Ireland (MFI) and the Irish Pharmaceutical Healthcare Association (IPHA), on the pricing and supply of medicines.
These agreements include commitments to reaching pricing and reimbursement decisions within 180 days, excluding stopclocks.
In addition, suppliers will aim to shorten the timeline to submit medicine reimbursement applications in Ireland to within six months of formal authorisation by the European Commission. Together these measures will enable faster access for patients in Ireland.
The Programme for Government contains a suite of measures on medicines which my officials will seek to progress over the lifetime of this Government. As part of the Agreement talks, 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. As this work progresses, it will be essential that we take account of the views of patients, of industry, and of clinicians. The mechanisms involved are complex, and the potential impacts must be carefully considered to ensure any future system is fair, effective, and sustainable. In parallel, my officials have commenced work examining reimbursement systems in use across the European Union.
