Written answers

Thursday, 17 July 2025

Department of Health

Medicinal Products

Photo of Pádraig O'SullivanPádraig O'Sullivan (Cork North-Central, Fianna Fail)
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532. To ask the Minister for Health to outline details of any programmes under which the HSE may facilitate access to medicines in emergency circumstances for medicines not on the reimbursement list; and if she will make a statement on the matter. [40320/25]

Photo of Jennifer Carroll MacNeillJennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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As this is an operational matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.

Photo of Pádraig O'SullivanPádraig O'Sullivan (Cork North-Central, Fianna Fail)
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533. To ask the Minister for Health the anticipated timelines associated with the Programme for Government commitment to explore early access schemes for reimbursement of medicines; and if she will make a statement on the matter. [40321/25]

Photo of Jennifer Carroll MacNeillJennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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The Government recognises the importance of timely access for patients to new medicines. 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.

Budgets 2021-2024 allocated an additional €128 million for new drugs, which has facilitated the introduction of 219 new medicines. Fifty-five (55) of these are orphan drugs for rare diseases. Budget 2025 allocated €30 million for new drugs to come from efficiencies to be identified by the HSE.

In 2023 a review of the drug reimbursement process was published. It found that the process was operating as intended and within international norms. Recommendations from the review have now 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.

Access to medicines requires industry and the State to work together, through timely assessment, and reasonable pricing with fully completed HTAs (Health Technology Assessments). The Government encourages pharmaceutical companies to submit timely applications for reimbursement.

My Department is looking at reimbursement systems across the European Union and working closely on access to medicines with Beneluxa partners, where we have had previous success.

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.

Photo of Pádraig O'SullivanPádraig O'Sullivan (Cork North-Central, Fianna Fail)
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534. To ask the Minister for Health the total expenditure on new medicines and new uses of existing medicines from January 2025 to 31 May 2025; and if she will make a statement on the matter. [40322/25]

Photo of Jennifer Carroll MacNeillJennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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As this is an operational matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.

Photo of Pádraig O'SullivanPádraig O'Sullivan (Cork North-Central, Fianna Fail)
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535. To ask the Minister for Health if she is satisfied that all aspects of the reimbursement process are in compliance with the HSE's code of governance; and if she will make a statement on the matter. [40323/25]

Photo of Jennifer Carroll MacNeillJennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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As this matter refers to the HSE's code of governance, and to decisions on the pricing and reimbursement of medicines and medical devices, which is a statutory responsibility of the HSE under the Health (Pricing and Supply of Medical Goods) Act 2013, the matter has been referred to the HSE for attention and direct reply to the Deputy.

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