Medicinal Products

Tuesday, 26 May 2026

Questions (1140, 1141, 1225, 1230, 1338)

Ken O'Flynn

Question:

1140. Deputy Ken O'Flynn asked the Minister for Health if the HSE maintains any national policy governing interim patient access to medicines awaiting reimbursement decisions for rare diseases. [38855/26]

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Ken O'Flynn

Question:

1141. Deputy Ken O'Flynn asked the Minister for Health if the Department or HSE has examined establishing a formal compassionate or early-access medicines framework for patients with rare progressive conditions pending health technology assistant and reimbursement determinations. [38856/26]

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Ken O'Flynn

Question:

1225. Deputy Ken O'Flynn asked the Minister for Health if her Department or HSE has considered establishing an accelerated reimbursement pathway for medicines relating to rare progressive neurological disorders. [39070/26]

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Ken O'Flynn

Question:

1230. Deputy Ken O'Flynn asked the Minister for Health if there is a mechanism permitting interim or conditional reimbursement for medicines treating progressive neurological diseases pending completion of the full reimbursement process. [39075/26]

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Duncan Smith

Question:

1338. Deputy Duncan Smith asked the Minister for Health with reference to the framework agreement on the supply and pricing of medicines 2026-2029's commitment to develop an early access scheme for rare diseases; if she will consider the equity of creating a fast-track for patients with rare diseases versus the track for patients whose diseases may not be rare but may have a greater clinical need; if she will consider the appropriateness of creating a two-speed system considering Section 21-2-D of the Health (Pricing & Supply of Medical Goods) Act 2013; if she agrees that an early access scheme should be an accelerator for patients whose medical needs are most urgent; if she will confirm that the principle of equity will be upheld in the planned early access scheme; and if she will make a statement on the matter. [39350/26]

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Written answers

Minister for Health

I propose to take Questions Nos. 1140, 1141, 1225, 1230 and 1338 together.

I recognise 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 has facilitated the introduction of 270 new medicines, 74 of which are for rare diseases.

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.