Dáil Éireann Debate, Wednesday - 22 April 2026
245. Deputy Ken O'Flynn asked the Minister for Health whether the current national rare disease strategy provides for expedited access pathways to disease-modifying therapies; and whether any review of this policy framework is underway. [29084/26]
View answerThe 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. It also emphasises the importance of access to orphan medicines among its key recommendations. 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, which has facilitated the introduction of 263 new medicines, from 2021 to March 2026, 72 of which are for rare diseases.
This has been facilitated by Budgets 2021-2025 which allocated an additional €158 million for new drugs. Budget 2026 allocated €217 million in additional funding for drugs, with €30 million of this allocated for new drugs funding.
There is no hierarchy of disease and pricing and reimbursement applications are considered in order of application.
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 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.
