Dáil Éireann Debate, Thursday - 5 March 2026
22. Deputy Peter Roche asked the Minister for Health if her Department has considered introducing an early access scheme for people living with rare diseases to access EMA-approved orphan medicines; if such an early access scheme will include orphan medicines products licensed for non-oncology conditions; and if she will make a statement on the matter. [17621/26]
View answerI recognise the importance of timely access for patients to new medicines and supporting those living with rare diseases in Ireland.
Government is committed to enhancing access to medicines for patients across Ireland. Supported by 158 million euros of funding, in the last four years, the State has delivered access to 250 new medicines. 101 of these were for cancer and 69 of these were for rare diseases. These include treatments for a wide range of conditions, such as severe forms of epilepsy, cystic fibrosis, and metachromatic leukodystrophy (MLD). Budget 2026 allocated 30 million euro in funding for new medicines.
It should be noted that once new medicines are approved the full cost of providing them as their uptake increases can reach multiples of their initial cost. For example, while €30m was made available to fund new medicines in 2024, the projected five-year budget impact of these medicines is €386m.
My immediate priority has been to deliver new Agreements with the pharmaceutical sector to create the environment for investment in new and innovative drugs and to provide timely access for patients.
We have just successfully concluded these new 4 Year Framework Agreements on the Supply and Pricing of Medicines with the Irish Pharmaceutical Healthcare Association and Medicines for Ireland.
These agreements include commitments to reaching pricing and reimbursement decisions within 180 days, excluding stop-clocks.
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. This aims to ensure timely patient access, as previously delayed submissions have slowed availability of treatments. There have been instances where suppliers have taken up to 30 months after European Commission authorisation to submit applications to Ireland’s Pricing and Reimbursement system, significantly prolonging access timelines.
Looking ahead, my Department and the HSE will progress the development of a sandboxed early access programme for rare diseases. It will be in the form of a proof-of-concept initiative. This is aligned with Programme for Government commitments. Research work has already commenced.
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. The State and the pharmaceutical sector have agreed to establish a strategic partnership which will support this work.
