Colm Burke (Cork North-Central, Fine Gael)
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197. To ask the Minister for Health if she will prioritise the Programme for Government commitment to investigate early access schemes for orphan medicines; and if she will make a statement on the matter. [34701/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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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 €128 million for new drugs which has allowed the HSE to approve 194 new medicines. Seventy four (74) of these drugs were for treating cancer and forty-nine (49) were drugs for rare diseases. Budget 2025 allocated 30 million euro for new drugs to come from efficiencies to be identified by the HSE.

A National Rare Disease Steering Group was established in December 2023. They were tasked with developing a new National Rare Disease Strategy. The Steering Group recently completed its work. I am currently considering the output of the Group's work.

The Health (Pricing and Supply of Medicines) Act 2013 provides nine criteria to be considered when evaluating a medicine for reimbursement. While a medicine costing over €45,000 per QALY may not be considered cost-effective, many medicines above this threshold have been approved for reimbursement in recent years.

In 2023, a review, by Mazars, of the drug reimbursement process was published. It found that the process was operating as intended and within international norms.

Recommendations from the Mazars Report 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. Given the unique technical skill set required for these roles, hiring was only completed in the second half of last year. It is expected that the impact of these staff will be seen as we continue through 2025.

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.