1176. Deputy Pádraig O'Sullivan asked the Minister for Health whether a specific strategy is being developed to improve access to rare disease and orphan medicines; and the measures under consideration. [64551/26]

1180. Deputy Pádraig O'Sullivan asked the Minister for Health if she will consider the introduction of a dedicated reimbursement pathway for rare disease and orphan medicines; the work undertaken to date in this regard; and if international models have been examined. [64547/26]

I propose to take Questions Nos. 1176 and 1180 together.

The Minister launched the new National Rare Disease Strategy 2025-2030 on 27th August 2025. This landmark strategy sets out a vision to improve the lives of the estimated 300,000 people living with rare diseases in Ireland. It outlines a comprehensive framework designed to enhance diagnosis, treatment, and support for people living with rare diseases, aiming to improve quality of life, promote equitable access to healthcare, and foster innovation in rare disease research and treatment.

The Strategy's 11 recommendations also emphasise the importance of developing and enabling earlier diagnosis, integrated care, data and registries, research and innovation, and access to orphan medicines. By addressing these areas, the Strategy aims to create a more inclusive healthcare service that meets the complex needs of people living with rare diseases. Implementation is underway through a newly established HSE led National Rare Disease Strategy Implementation Steering Group and a dedicated three-year implementation plan in currently being finalised.

For a medicine to be reimbursed by the HSE it must undergo HSE’s pricing and reimbursement process for medicines.

Budgets 2021-2025 allocated €158 million for new drugs. This has facilitated the introduction of 250 new medicines/new uses for existing medicines, including 101 for oncology and 70 for rare diseases. As you will be aware, this investment largely reflects the initial in year expenditure associated with a drug approved in any given year - the actual budget implications for each drug approval are considerably higher over a number of years.

Budget 2026 allocated €30 million of funding available for new drugs to be allocated from the overall additional €217 million in funding provided this for the medicines budget. This has enabled the funding of 40 new medicines/new uses for existing medicines, including 17 for oncology and 9 for rare diseases, for the period from January 2026-3rd September 2026.

There is a suite of measures, that have been implemented and are to be implemented to shorten the timeframe from the issue of a Marketing Authorisation on foot of a positive opinion by the European Medicines Agency to a decision on whether to reimburse the medicine by the HSE's Senior Leadership Team.

These measures include:

• Funding by the Government to an almost doubling of capacity in the HSE’s pricing and reimbursement system with 34 additional staff

• New Framework Agreements on the Supply and Pricing of Medicines with Medicines for Ireland (MFI) and the Irish Pharmaceutical Healthcare Association (IPHA) which provide commitments and towards achieving a 180-day timeline for completing health technology assessments (HTA) and reimbursement decisions following application by the Marketing Authorisation Holder.

• A commitment from Irish Pharmaceutical Healthcare Association (IPHA) member companies to aim to shorten the timeline to submit reimbursement applications in Ireland to within six months of formal authorisation of medicines by the European Commission.

A key priority and area of focus is to reduce the timeline for reimbursement decisions to consistently meet 180 days. The recently commissioned end-to-end process review of the reimbursement system is primarily targeted at supporting this objective.

The Programme for Government contains a commitment to examine the development of early access schemes for rare diseases. 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 and recommendations in the National Rare Disease Strategy 2025–2030. Scoping and research work is underway by the Department, including examining models in other jurisdictions.