James O'Connor (Cork East, Fianna Fail)
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201. To ask the Minister for Health the means by which she will ensure that patients have access to new innovative medicines and treatments as quickly as possible, especially for rare diseases; and if she will make a statement on the matter. [24095/25]

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.

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.

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.

A record of over €3 billion, nearly €1 in every €8 of public funding spent on health, was spent in 2023 on medicines. This is an unprecedented level of investment in supporting patients through the availability of the latest and wide range of medicines.

The State has made an additional €128 million available for new drugs between 2020 and 2024. Up to November 2024, this has seen 194 new medicines approved for reimbursement by the HSE including 74 oncology drugs and 46 orphan medicines for rare diseases.

For 2025 an additional €30m will be made available for new drugs funding, through efficiencies identified by the joint DOH-HSE Medicines Sustainability Taskforce.

Along with increased investment in the budget for new medicines, the Mazars Report published in 2023 found that the HSE Pricing and Reimbursement system was operating as intended and within international norms.

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, 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.

The HSE has statutory responsibility for decisions on pricing and reimbursement of medicines under the community drugs schemes, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013. All medicines are considered for pricing of reimbursement in order of application. In making a reimbursement decision, the HSE must ensure that the best possible price is achieved for new medicines, having regard to efficacy, the health needs of the public and potential budget impact.