Pádraig O'Sullivan (Cork North-Central, Fianna Fail)
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641. To ask the Minister for Health if she plans to review the drugs reimbursement process and plans; if she will consider investigating new methods for earlier reimbursement of certain treatments, including early access for rare diseases; and if she will make a statement on the matter. [4309/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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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. The total spend on oncology drugs in this period has exceeded €645 million.

Up to November 2024, this has seen 204 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. The Minister for Health will ensure that her Department, the HSE and all relevant agencies and stakeholders place a priority focus on achieving the most efficient and effective use of available resources.

Once a company responsible for the commercialisation of a new medicine receives marketing authorisation from the European Medicines Agency (EMA), it can apply for reimbursement in the country (or countries) of its choice. The timing of company applications for new medicines reimbursement in different countries can vary for several reasons, not least the available market share in each country. Ireland, by virtue of its size and market share, may not always be prioritised by a company in the first stages of marketing a new product. The reimbursement assessment process cannot begin until an application is received.

Ireland encourages all pharmaceutical companies to apply to the HSE to have their medicines added to the reimbursement list.

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

Amongst its observations, the report recommended the introduction of a Medicines Reimbursement Application Tracker to demonstrate how a medicine is progressing through the process. This will enhance transparency for patients and provide applicant companies real time visibility on a new medicine application. The tracker was launched in December 2024.

As recommended in the Mazars Report, the Government allocated significant funding for an additional 34 WTE for the agencies involved in the HSE’s medicines pricing and reimbursement system. These additional staff will allow each agency to operate to its full potential, ensuring timely and efficient assessment of applications.