Dáil Éireann Debate, Tuesday - 14 April 2026
2811. Deputy Pádraig O'Sullivan asked the Minister for Health to provide an update on the implementation of the revised pharmaceutical framework agreements; the way in which the HSE intends to operate the clock-stop procedures; whether all dates relevant to clock stops will be published via a reimbursement; and if she will make a statement on the matter. [24359/26]
Amharc ar fhreagra2812. Deputy Pádraig O'Sullivan asked the Minister for Health the changes to the reimbursement system forthcoming on foot of the new pharmaceutical framework agreements; the assurances that can be given to patients that decisions on medicines will be made faster; and if the governance of the reimbursement system will ensure this; and if she will make a statement on the matter. [24360/26]
Amharc ar fhreagraI propose to take Questions Nos. 2811 and 2812 together.
The Government is committed to investing in new medicines for patients, which has facilitated the introduction of 263 new medicines from 2021 to date. The Year 1 cost of a new drug comes from the allocation for new medicines, but it should be noted that once these medicines are approved for reimbursement the full cost of providing them can reach multiples of this initial cost as their uptake increases. For 2026, over €200m is available for medicines including €30 million for new medicines.
The State has successfully negotiated new Framework Agreements on the Supply and Pricing of Medicines with Medicines for Ireland (MFI) and the Irish Pharmaceutical Healthcare Association (IPHA).
These Agreements provide commitments and a structured process towards achieving a 180-day timeline, for completing health technology assessments (HTA) and reimbursement decisions. The structured process will be implemented over the lifetime of the Agreement and will involve, starting this year, conducting an end-to-end review of the pricing and reimbursement system. This will enable faster access to new medicine for patients across Ireland.
The Health Service Executive (HSE) has statutory responsibility for decisions on pricing and reimbursement of medicines and medical items, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013.
A recommendation of the Mazars Review, published in 2023, was the implementation of a pricing and reimbursement medicines tracker to be developed by the HSE. This tracker has now been launched with the initial iteration available since December 2024. The HSE National Service Plan will continue the tracker’s development.
Stop-clocks will continue to be utilised throughout the pricing and reimbursement process in line in the Framework Agreements on the Supply and Pricing of Medicines with MFI and IPHA in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013.
Starting in 2026, the capacity of the HSE Drugs Group will be enhanced to facilitate a greater capacity to process applications, including those currently under consideration. A monitoring framework within the Pricing and Reimbursement system will support oversight of progress during the lifetime of the Agreement.
In addition to the commitment to pricing and reimbursement decisions within 180 days exclusive of stopclocks, IPHA member companies will aim to shorten the timeline to submit reimbursement applications in Ireland to within six months of formal authorisation of medicines by the European Commission (as recommended by the European Medicines Agency – EMA). Together these measures will enable faster access to medicines for patients in Ireland.
A joint oversight committee will monitor delivery of commitments, including timelines to reimbursement, access to new medicines, and agreed financial sustainability measures. Further, recognising the continued value in strengthening partnerships between the State and pharmaceutical representative body, the Agreement creates structures for enhanced and more frequent engagement throughout the life of the Agreement.
