Dáil Éireann Debate, Wednesday - 1 July 2026
310. Deputy Erin McGreehan asked the Minister for Health the steps being taken to ensure Irish patients have timely and equitable access to innovative oncology treatments, including radioligand therapies such as pluvicto; and the way Ireland compares with other EU Member States in access to such treatments. [50112/26]
View answerThe Government recognises the importance of timely access for patients to new medicines and supporting those living with rare diseases in Ireland. Budgets 2021-2025 allocated €158 million for new drugs, and Budget 2026 allocated an additional €30 million. Since 2021, this funding has facilitated the introduction of 276 new medicines, including 75 medicines for rare diseases and 110 for treating cancer.
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.
Ireland is among the highest spenders on health across the EU (OECD), with the third-highest rate of State coverage of pharmaceutical expenditure in Europe.
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.
Once a company responsible for the commercialisation of a new medicine receives marketing authorisation, it can apply for reimbursement in the country (or countries) of its choice. 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 describing timelines for reimbursement from EMA approval to HSE reimbursement approval do not consider this important factor and misrepresent the process, as statutorily the HSE is not able to add a new medicine to the reimbursement list until an application is received. Additionally, the initial commercial offering from manufacturers for medicines can have significant implications for the negotiation process, including its duration.
In the context of a finite health budget, it is vital that the State ensures good value for money for public expenditure, and to ensure that the available budget maximises as much access as possible to medicines and other healthcare services for patients.
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 a structured process towards achieving a 180-day timeline for reimbursement decisions by Q1 2029.
• 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.
