I propose to take Questions Nos. 282 and 290 together.
The Government recognises the importance of timely access for patients to new medicines and supporting those living with rare diseases in Ireland. Budgets 2021-2025 allocated €158 million for new drugs, and Budget 2026 allocated an additional €30 million. Since 2021, this funding has facilitated the introduction of 270 new medicines, including 74 medicines for rare diseases and more than 100 for treating cancer.
The Year 1 cost of a new drug comes from the allocation for new medicines, but it should be noted that once these medicines are approved for reimbursement the full cost of providing them can reach multiples of this initial cost as their uptake increases.
Ireland is among the highest spenders on health across the EU (OECD), with the third-highest rate of State coverage of pharmaceutical expenditure in Europe.
There are formal processes which govern applications for the pricing and reimbursement of medicines, and new uses of existing medicines, to be funded and / or reimbursed. The HSE is the statutory decision maker for the pricing and reimbursement of new medicines under the Health (Pricing and Supply of Medical Goods) Act 2013. The HSE considers the criteria set out in the Act. The Minister for Health has no role in decisions on pricing and reimbursement.
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.
