Barry Heneghan (Dublin Bay North, Independent)
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1523. To ask the Minister for Health if work has begun to explore early access schemes for certain medicines, as outlined in the Programme for Government; the person in her Department that will have responsibility for this work; if this will include a review of early access schemes already operating in other European countries; and if she will make a statement on the matter. [30015/25]

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 the 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.

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.

The State has made considerable investments in new medicines in recent years. In 2023, over €3.2 billion was spent on medicines by the State. This represents nearly €1 in every €8 of public funding being spent on health.

This level of investment is unprecedented in supporting patients through the availability of new and innovative medicines.

Budgets 2021 to 2024 have included dedicated funding for new medicines of one hundred and twenty-eight million euros. This has enabled the HSE to approve reimbursement for 194 new medicines or new uses for existing medicines, including seventy-four for treating cancer and forty-nine for treating rare diseases.

Budget 2025 allocated €30 million of funding available for new drugs to be generated by efficiencies to be identified by the HSE.