I propose to take Questions Nos. 272 and 281 together.
The Programme for Government contains a suite of measures on medicines, which we aim to progress over its lifetime. Access to medicines is the focus of a number of workstreams across the Department.
As outlined in the Programme for Government, consideration will be given to early access mechanisms for medicines. These mechanisms and their effects are complex and must be evaluated carefully.
In Ireland, compassionate access schemes are entirely at the discretion of the manufacturer. There is no provision in Irish legislation for the approval of compassionate use programmes for specific groups of patients with an unmet medical need. The Minister for Health has no role or powers in this regard.
The State has made considerable investments in new medicines in recent years. In 2023, over €3.2 billion was spent on medicines by the State. This represents nearly €1 in every €8 of public funding being spent on health.
Budgets 2021 to 2025 included dedicated funding for new medicines of €158 million. This has enabled the HSE to approve reimbursement for 244 new medicines or new uses for existing medicines, including 101 for treating cancer and 67 for treating rare diseases.
Budget 2026 allocated €30 million of funding available for new drugs to be allocated from the overall additional €217 million in funding allocated for medicines.
This level of investment is unprecedented in supporting patients through the availability of new and innovative medicines.
Ireland is open for business and once a drug is granted marketing authorisation we strongly encourage all pharmaceutical companies to apply for reimbursement here in Ireland.
The Minister for Health launched the new National Rare Disease Strategy 2025-2030 in August 2025, which has a vision to ensure that all people living with a rare disease have access to equitable, inclusive, safe and cross-sectoral care throughout their life journey that will enable them to reach their full potential and to live their best lives.
Funding of €1.5m was provided in Budget 2025 for the development of supports and services for people living with a rare disease in Ireland. This includes the allocation of approximately 34WTE to support staffing services. An additional €5m in recurrent funding is provided to support the implementation of the National Rare Disease Strategy, across all 11 of its recommendations. These funds were allocated to the HSE in 2025 for the development of rare disease services.
