3310. Deputy John Lahart asked the Minister for Health the position regarding the establishment of an early access scheme for orphan medicines; and if she will make a statement on the matter. [55774/26]

3631. Deputy Pádraig Rice asked the Minister for Health if she will meet with an organisation (details supplied) regarding implementing an early access scheme; and if she will make a statement on the matter. [57126/26]

3872. Deputy Pádraig Rice asked the Minister for Health further to Parliamentary Question No. 290 of 27 May 2026, to provide an update on the development of a sandboxed early access programme for rare diseases; if there has been any progress or developments since May; the timeline she is working towards; and if she will make a statement on the matter. [58074/26]

4069. Deputy Rory Hearne asked the Minister for Health to outline the progress her Department has made in reducing the turnaround for reimbursement decisions for orphan drugs; and if she will make a statement on the matter. [59085/26]

4070. Deputy Rory Hearne asked the Minister for Health to provide an update on development of a pathway to timely orphan drug approval; and if she will make a statement on the matter. [59086/26]

I propose to take Questions Nos. 3310, 3631, 3872, 4069 and 4070 together.

The Government is committed to investing in new medicines. Supported by €158 million of funding in Budgets 2021-2025, the State delivered access to 250 new medicines. 70 of these were for rare diseases. Budget 2026 allocated €217 million additional investment in medicines, including €30 million in funding for new medicines. This has, as of June 2026, delivered access to 30 new medicines, including 7 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.

Once a company responsible for the commercialisation of a new medicine receives marketing authorisation following an opinion of the European Medicines Agency (EMA), it can apply for reimbursement in the country (or countries) of its choice. Ireland, by virtue of its size and market share, may not always be prioritised by a company in the first stages of marketing a new product.

Reports describing timelines for reimbursement from EMA approval to HSE reimbursement approval do not consider this important factor and misrepresent the process, as statutorily the HSE is not able to add a new medicine to the reimbursement list until an application is received. Additionally, the initial commercial offering from manufacturers for medicines can have significant implications for the negotiation process, including its duration.

Two new Framework Agreements on the Supply and Pricing of Medicines (FASPM) between the State and Medicines for Ireland and the Irish Pharmaceutical Health Association respectively were signed on the 3rd of March for the period 2026-2029.

These Agreements include a commitment and a structured process towards achieving a 180-day timeline for reimbursement decisions by Q1 2029, accelerating patient access to new treatments. The structured process will be implemented over the lifetime of the Agreements and will involve an end-to-end review of the pricing and reimbursement system, considering every stage of the process.

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.

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, officials have commenced work examining reimbursement systems in use across the European Union.

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 (PLWRD) 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 PLWRD 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.