Dáil Éireann Debate, Tuesday - 19 May 2026
1238. Deputy Pádraig Rice asked the Minister for Health if she will commit to establishing early access schemes for new medicines for the treatment of rare diseases; and if she will make a statement on the matter. [37774/26]
Amharc ar fhreagra1239. Deputy Pádraig Rice asked the Minister for Health the status of the Programme for Government commitment and National Rare Disease Strategy recommendation to consider early access schemes for rare diseases; the status of these considerations; the work carried out to date; the timeline she is working towards in completing this work; and if she will make a statement on the matter. [37775/26]
Amharc ar fhreagraI propose to take Questions Nos. 1238 and 1239 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 262 new medicines since 2021 including 72 for rare diseases. For 2026, over €217m of additional funding has been made available for medicines including €30 million for new medicines.
The State has successfully negotiated new Framework Agreements 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, the developers of new medicines 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.
