Grace Boland (Dublin Fingal West, Fine Gael)
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1866. To ask the Minister for Health when she intends to launch the review into Ireland's reimbursement process; and if she will make a statement on the matter. [12554/25]

Grace Boland (Dublin Fingal West, Fine Gael)
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1871. To ask the Minister for Health the steps she will take to implement the Programme for Government's commitment to introduce early access/interim access schemes for patients who require urgent access to EMA-approved treatments in advance of a decision to reimburse the treatment in Ireland; and if she will make a statement on the matter. [12559/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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I propose to take Questions Nos. 1866 and 1871 together.

The State is committed to providing timely access to new and innovative medicines to all patients. Budgets 2021 - 2024 provided almost €130 million of dedicated funding for new drugs. This enabled the HSE to approve 194 new drugs, including 74 oncology drugs and 49 drugs for rare diseases. Budget 2025 has allocated €30 million in funding for new medicines to be generated by efficiencies identified by the HSE.

Once a company responsible for the commercialisation of a new medicine receives marketing authorisation from the European Medicines Agency (EMA), it can apply for reimbursement in the country (or countries) of its choice. The timing of company applications for new medicines reimbursement in different countries can vary for several reasons, not least the available market share in each country. 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. The reimbursement assessment process cannot begin until an application is received.

In February 2023, the Mazars Review on the pricing and reimbursement system was published. While the review found that the pricing and reimbursement system in Ireland was in line with international norms a number of recommendations were made on foot of its findings.

One of the key recommendations was the provision of additional staffing for the pricing and reimbursement system, to enhance and speed up the pricing and reimbursement application process for new medicines. The Government allocated significant funding for the hiring of 34 new staff across the pricing and reimbursement system. The recruitment campaigns for all these posts have now concluded and staff have been hired. Given the specialised skillset required for these roles, recruitment was a complex endeavour which only reached completion in the second half of 2024. As a result, their full impact on the speed of assessment of new medicine applications will become evident in the coming months. This measure will shorten the time taken to reach decisions on reimbursement applications and allow faster access to new medicines for patients.

Another recommendation of the Mazars Review was greater transparency for all stakeholders. A key focus of this recommendation 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.

This will show in real time from Rapid Review to a final decision by the HSE, the status of a reimbursement application for a new medicine. This will provide transparency and certainty to patients and industry on the current status of the pricing and reimbursement applications of a drug.

For 2025, the HSE National Service Plan will continue the tracker’s development with the introduction of indicative timelines for each step of a medicine’s assessment process.

Ireland is open for business and actively encourages all Marketing Authorisation holders of new medicines to apply for pricing and reimbursement in Ireland as soon as marketing authorisation is granted by the European Medicines Agency.