Dáil Éireann Debate, Tuesday - 19 May 2026
989. Deputy Ken O'Flynn asked the Minister for Health whether any assessment has been carried out regarding the impact on patient access arising from the absence of statutory or administrative deadlines for the submission of commercial proposals by marketing authorisation holders. [36588/26]
Amharc ar fhreagra990. Deputy Ken O'Flynn asked the Minister for Health whether consideration has been given to introducing statutory or regulatory timeframes governing engagement by marketing authorisation holders once invited to submit a commercial proposal to the HSE. [36589/26]
Amharc ar fhreagra992. Deputy Ken O'Flynn asked the Minister for Health whether any escalation mechanism exists where a pricing and reimbursement application remains inactive for an extended period due to the absence of a commercial proposal from a marketing authorisation holder. [36591/26]
Amharc ar fhreagra993. Deputy Ken O'Flynn asked the Minister for Health whether the absence of formal timelines for commercial engagement by marketing authorisation holders has been identified as a governance, transparency or patient-access risk within the medicines reimbursement system. [36592/26]
Amharc ar fhreagra994. Deputy Ken O'Flynn asked the Minister for Health whether any comparative review has been carried out examining how other EU jurisdictions manage delays by marketing authorisation holders during medicines pricing and reimbursement negotiations. [36593/26]
Amharc ar fhreagraI propose to take Questions Nos. 989, 990, 992, 993 and 994 together.
The State recognises the importance of timely access to innovative medicines for patients in Ireland.
Budgets 2021-2025 allocated an additional €158 million for new drugs, which has facilitated the introduction of 263 new medicines. Budget 2026 allocated €30 million of funding available for new drugs to be allocated from the overall additional €217 million in funding allocated for medicines.
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.
There 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 Minister for Health has no role in decisions on pricing and reimbursement.
There is no hierarchy of disease and pricing and reimbursement applications are considered in order of application.
The HSE must comply with the relevant legislation when considering investment decisions around new medicines. Pharmaceutical companies are required to submit formal applications to the HSE if they wish their medicines to be added to the list of reimbursable items / funded via hospitals and must continue to engage with the HSE throughout the process.
The State has successfully negotiated new Framework Agreements with Medicines for Ireland (MFI) and the Irish Pharmaceutical Healthcare Association (IPHA), on the pricing and supply of medicines.
These agreements include commitments to reaching pricing and reimbursement decisions within 180 days, excluding stopclocks.
In addition, the developers of new medicines will aim to shorten the timeline to submit medicine reimbursement applications in Ireland to within six months of formal authorisation by the European Commission. Together these measures will enable faster access for patients in Ireland.
