Dáil Éireann Debate, Thursday - 2 October 2025
458. Deputy Ken O'Flynn asked the Minister for Health to provide comparative data on the time from European Medicines Agency approval to reimbursement for new oncology medicines in Ireland versus other EU member states; and to indicate whether Ireland is above or below the EU average. [52829/25]
Amharc ar fhreagraThe HSE has statutory responsibility for decisions on the pricing and reimbursement of medicines. This arises from the Health (Pricing and Supply of Medical Goods) Act 2013.
Reimbursement is for licensed indications which have been granted marketing authorisation by the European Medicines Agency (EMA) or the Health Products Regulatory Authority (HPRA). Pharmaceutical companies must apply to the HSE for reimbursement.
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. This is an important factor affecting the timelines for reimbursement from EMA approval to HSE reimbursement approval, as statutorily, the HSE cannot add a new medicine to the reimbursement list until an application is received.
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.
Ireland encourages all pharmaceutical companies to apply to the HSE to have their medicines added to the reimbursement list once granted marketing authorisation by the European Medicines Agency. Reimbursement timelines vary by country due to market size and company strategy.
An external review of the pricing and reimbursement process, the Mazars Review, was published in 2023. The Mazars Review determined that the pricing and reimbursement process operated in line with international norms and made a number of recommendations to improve the process, resulting in:
1) the implementation of an application tracker for the medicines assessment process which was launched by the HSE in 2024.
2) the hiring of 34 staff across the pricing and reimbursement system in 2024.
These measures will enable the assessment of a greater number of medicines at a quicker pace and provide transparency to all stakeholders including patients around the status of the pricing and reimbursement application of a new treatment.
