Dáil Éireann Debate, Wednesday - 27 May 2026
229. Deputy John Connolly asked the Minister for Health the steps being taken to ensure compliance by the HSE with the statutory requirement (details supplied) under the Health (Pricing and Supply of Medical Goods) Act 2013 to make reimbursement decisions within 180 days of receiving an application; and if she will make a statement on the matter. [40477/26]
Amharc ar fhreagraThere 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 HSE has advised that once a medicine is approved by the European Medicines Agency, the HSE is dependent on a pharmaceutical company making an application to Ireland for its drug or new indication to be assessed for reimbursement. Medicines are considered for pricing of reimbursement in order of application.
While many companies engage proactively with the HSE, Ireland, by virtue of its size and market share, may not always be prioritised by some companies in the first stages of marketing a new medicine. Reports describing timelines for reimbursement from EMA approval to HSE reimbursement approval do not consider this important factor, as statutorily the HSE are not able to add a new medicine to the reimbursement list until an application is received. The HSE will continue to assess and progress applications as efficiently as possible.
Additional resources provided in 2024 have strengthened the pricing and reimbursement system, including additional staffing to increase capacity and the development and launch of a new HSE application tracker to enhance transparency.
In new Framework Agreements on the Supply and Pricing of Medicines, which have been agreed with Medicines for Ireland (MFI) and the Irish Pharmaceutical Healthcare Association (IPHA), the State commits to achieving a 180-day timeline for completing health technology assessments (HTA) and reimbursement decisions.
The agreements outline a structured process towards achieving this 180-day commitment by Q1 2029, accelerating patient access to new treatments. The agreements also include a commitment from IPHA member companies to aim to shorten the timeline to submit reimbursement applications in Ireland to within six months of marketing authorisation of medicines by the European Commission.
The State, IPHA, and MFI agree 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. The Department of Health are examining early access mechanisms across the EU for the Minister for Health’s further consideration.
