3306. Deputy Michael Cahill asked the Minister for Health to meet with an organisation (details supplied) to discuss a multi-stakeholder group being established without delay; to provide recommendations on the way in which to implement an early access scheme, with the goal of access within one year of European Medicines Agency authorisation; and if she will make a statement on the matter. [59843/26]

The National Rare Disease Strategy 2025–2030, was launched last year. The strategy 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. An Implementation Oversight Group has been launched and met in February to begin work planning for the 11 recommendations.

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.

Budget 2026 allocated €30 million of funding available for new drugs to be allocated from the overall additional €217 million in funding. 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.

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.