Pádraig O'Sullivan (Cork North-Central, Fianna Fail)
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130. To ask the Minister for Health the progress made regarding commitments in the Programme for Government surrounding rare diseases and specifically plans for a review of the drug reimbursement process, increasing the number of clinical trials and providing an early access scheme for new drug and treatment; and if she will make a statement on the matter. [23511/25]

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.

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 National Clinical Trials Oversight Group was established in 2024 to identify challenges and recommend solutions to increase the number of clinical trials taking place in Ireland. Their final recommendations will be delivered later this year.

I appreciate that the Deputy has a strong interest in making medicines available to patients with rare diseases in Ireland. However, it is important to note that 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. Supported by 128 million euros of funding, we have delivered access to 194 new medicines between 2021 and 2024. Forty-nine (49) of these are for rare diseases.

Recommendations from the Mazars Report have been implemented. A pricing and reimbursement application tracker has been launched to improve transparency. In 2024 an additional 34 staff, an increase of over 80%, 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.

Budget 2025 allocated 30 million euro for new drugs to come from efficiencies to be identified by the HSE.