Colm Burke (Cork North-Central, Fine Gael)
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184. To ask the Minister for Health the steps she will take to ensure that Irish cancer patients are not waiting longer than the EU average to access new medicines; and if she will make a statement on the matter. [9952/25]

Colm Burke (Cork North-Central, Fine Gael)
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183. To ask the Minister for Health to consider implementing the improvements in the approval process recommended in the Mazars review, including increased staffing for the national cancer control programme and National Centre for Pharmacoeconomics, an application tracker, greater transparency and indicative timelines for the approval of medicines; and if she will make a statement on the matter. [9951/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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I propose to take Questions Nos. 184 and 183 together.

Budgets 2021 to 2024 provided nearly €130 million for new drugs, enabling the HSE to approve 194 new drugs, including 74 for cancer. Budget 2025 allocated €30 million for new drugs to be generated by efficiencies identified by the HSE.

Between 2021 and 2024, €645 million was spent on oncology drugs. New treatments such as CAR T-cell therapy, radiolabelled therapy, and specialised radiotherapy treatments are now available for the first time in Ireland.

The HSE is responsible for decisions on pricing and reimbursement under the Health (Pricing and Supply of Medical Goods) Act 2013 for licensed indications granted market authorisation by the EMA or HPRA. Companies must submit an application to the HSE to add a new medicine to the reimbursement list once marketing authorisation is granted.

The Health (Pricing and Supply of Medical Goods) Act 2013, ensures a rigorous assessment process for new medicines, providing confidence that the right medicines are chosen at sustainable prices. Economic assessments help stretch HSE funds to provide a range of services and innovative medicines, including cancer treatments. The HSE considers clinical effect, cost-effectiveness, budget impact, opportunity cost, and unmet need when assessing applications.

The timing of reimbursement applications varies by country and Ireland may not always be prioritised by marketing authorisation holders due to its market size. The HSE cannot assess a drug until an application is received. The State encourages all pharmaceutical companies to apply for pricing and reimbursement of their drugs including oncology drugs as soon as marketing authorisation is granted by the European Medicines Agency.

On foot of the Mazars Review of the pricing and reimbursement system in Ireland, significant funding was allocated for additional resources across the system. The recruitment campaigns have now concluded and 34 additional staff are now hired. This will enhance the pricing and reimbursement process and further incentivise marketing authorisation holders to apply to have their medicines reimbursed.

For transparency a new medicines tracker was also developed and launched by the HSE and is now live. This will provide transparency and certainty to patients and industry on the current status of the pricing and reimbursement application of a drug.

For 2025, the HSE National Service Plan will continue the tracker’s development with the introduction of indicative timelines for each step of a medicine’s assessment process.