Dáil Éireann Debate, Thursday - 7 May 2026
540. Deputy Ken O'Flynn asked the Minister for Health to clarify the current operational status of any early access or compassionate access schemes for rare disease medicines; and to confirm whether any such schemes are currently available to patients in Ireland. [33756/26]
View answerI 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 HSE PCRS do not currently operate or fund any early access or compassionate access schemes.
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.
As part of the Agreement talks, the State and the pharmaceutical sector have agreed to establish a strategic partnership on the development of sandboxed early access programmes 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.
