Pádraig Rice (Cork South-Central, Social Democrats)
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866. To ask the Minister for Health her plans to agree and progress the early access programme for rare diseases; the timeline she is working towards; and if she will make a statement on the matter. [38734/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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The Government recognises the importance of timely access for patients to new medicines.

The Programme for Government contains a suite of measures on medicines, which we aim to progress over its lifetime. Access to medicines is the focus of a number of workstreams across my Department.

Budgets 2021-2024 allocated an additional €128 million for new drugs, which has facilitated the introduction of 219 new medicines. Fifty-five (55) of these are orphan drugs for rare diseases. Budget 2025 allocated €30 million for new drugs to come from efficiencies to be identified by the HSE.

In 2023 a review of the drug reimbursement process was published. It found that the process was operating as intended and within international norms. Recommendations from the review have now been implemented. A pricing and reimbursement application tracker has been launched to improve transparency. In 2024 an additional 34 staff were recruited to enhance capacity across the pricing and reimbursement system.

Access to medicines requires industry and the State to work together, through timely assessment, and reasonable pricing with fully completed HTAs (Health Technology Assessments). The Government encourages pharmaceutical companies to submit timely applications for reimbursement.

My Department is looking at reimbursement systems across the European Union and working closely on access to medicines with Beneluxa partners, where we have had previous success.

As outlined in the Programme for Government, consideration will be given to early access mechanisms for medicines. These mechanisms and their effects are complex and must be evaluated carefully.