Dáil Éireann Debate, Thursday - 5 March 2026
60. Deputy Peter Roche asked the Minister for Health when she intends to commence a review of the reimbursement process, as committed to in the Programme for Government; whether such a review will specifically include the way in which orphan medicines are assessed and reimbursed; and if she will make a statement on the matter. [17622/26]
Amharc ar fhreagraI thank the Deputy for his question on this matter.
The Programme for Government (Securing Ireland's Future) contains a suite of measures on medicines which my officials will seek to progress over the lifetime of this government.
Supported by 158 million euros of funding, in the last four years, the State has delivered access to 250 new medicines. Sixty-nine (69) of these drugs were for rare diseases. Budget 2026 allocated 30 million euro in funding for new medicines.
The Mazars Review published in 2023 found that Ireland’s pricing and reimbursement system was operating as intended and within international norms. A number of key recommendations were made on foot of this review which led to significant additional funding being allocated in 2024 to support staffing across the pricing and reimbursement system and the introduction of a HSE application tracker to improve transparency.
The State has successfully negotiated a new Agreement in Principle on the Supply and Pricing of Medicines with IPHA, commencing this year and running until the end of 2029. This agreement sets out a clear commitment and structured process aimed at achieving a 180-day timeline for completing health technology assessments and reimbursement decisions. The process will be implemented throughout the Agreement’s duration.
As part of FASPM 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.
Under the Health (Pricing and Supply of Medical Goods) Act 2013, the HSE has statutory responsibility for medicine pricing and reimbursement. Reimbursement applies to licensed indications approved by the EMA or HPRA.
Pricing and reimbursement applications are considered in order of application and there is no hierarchy of disease.
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 that measure timelines from EMA approval to HSE reimbursement often overlook this factor. Ensuring timely access requires collaboration between industry and the State, supported by reasonable pricing and complete, high-quality dossiers.
