Pádraig O'Sullivan (Cork North-Central, Fianna Fail)
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990. To ask the Minister for Health the steps she is taking, as per the Programme for Government commitments, to undertake a review of the drug reimbursement process; and if she will make a statement on the matter. [17359/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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The recently published Programme for Government (Securing Ireland's Future) contains a suite of measures on medicines which my officials will seek to progress over the lifetime of this government.

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.

On foot of this review significant funding was allocated by Government for an additional 34 staff across the pricing and reimbursement system. These staff have now been hired. Given the specialised skillset required for these roles, recruitment was a complex endeavour which only reached completion in the second half of 2024. As a result, their full impact on the speed of assessment of new medicine applications will become evident in the coming months.

A further recommendation of the Mazars Review was the introduction of an application tracker by the HSE to support transparency. The initial version of the HSE’s application tracker has now launched. This will allow patients and industry alike to have a substantive overview on the pricing and reimbursement application for a medicine. 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.

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 once granted marketing authorisation by the European Medicines Agency.

Pádraig O'Sullivan (Cork North-Central, Fianna Fail)
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991. To ask the Minister for Health if she is aware of the situations where private health insurers are in some cases covering access to drugs and orphan drugs for their clients and the very same drugs are not available to public patients; if he is aware of this two tier approach; and if she will make a statement on the matter. [17360/25]

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 2021 and 2024.

Up to December 2024, this has seen 194 new medicines approved for reimbursement by the HSE including 74 oncology drugs and 49 orphan medicines for rare diseases.

For 2025 an additional €30m has been made available for new drugs funding, through efficiencies to be identified by the joint DOH-HSE Medicines Sustainability Taskforce. As Minister for Health I will ensure that the 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 once granted marketing authorisation by the European Medicines Agency.

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.

On foot of this review significant funding was allocated by Government for an additional 34 staff across the pricing and reimbursement system. These staff have now been hired. Given the specialised skillset required for these roles, recruitment was a complex endeavour which only reached completion in the second half of 2024. As a result, their full impact on the speed of assessment of new medicine applications will become evident in the coming months.

A further recommendation of the Mazars Review was the introduction of an application tracker by the HSE to support transparency. The initial version of the HSE’s application tracker has now launched. This will allow patients and industry alike to have a substantive overview on the pricing and reimbursement application for a medicine. 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.

As Minister for Health, I regulate the private health insurance market. This is a voluntary market, which is underpinned by certain principles, including minimum benefit, that are set out in law. The Health Insurance Act 1994 (Minimum Benefit) Regulations 1996 require insurers to offer a minimum level of cover to every insured person. I do not have a role in the commercial decision-making of any private health insurer.

Pádraig O'Sullivan (Cork North-Central, Fianna Fail)
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992. To ask the Minister for Health if the full budget for new medicines was drawn down by the HSE in 2020, 2021, 2022, 2023, 2024; and if she will make a statement on the matter. [17361/25]

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

Pádraig O'Sullivan (Cork North-Central, Fianna Fail)
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993. To ask the Minister for Health the number of new medicines approved per annum in 2020, 2021, 2022, 2023, 2024; and if she will make a statement on the matter. [17362/25]

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

Pádraig O'Sullivan (Cork North-Central, Fianna Fail)
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994. To ask the Minister for Health the overall extent of pharmaceutical expenditure per annum in 2021, 2022, 2023, 2024, in tabular form; and if she will make a statement on the matter. [17363/25]

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

Pádraig O'Sullivan (Cork North-Central, Fianna Fail)
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995. To ask the Minister for Health the protocols and processes available or used by pharmacists to return unused medicines or to redistribute any paid for, yet unused medicines in the wider pharmacy sector; and if she will make a statement on the matter. [17364/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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The Health Service Executive (HSE) or the Department does not have oversight of stock in private pharmacies. Private pharmacies operate independently and manage their own inventory of medicines, including the handling of expired or unused medications.

Pádraig O'Sullivan (Cork North-Central, Fianna Fail)
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996. To ask the Minister for Health the value of drugs, particularly orphan drugs, that go unused for one reason or another per annum; the way her Department is attempting to limit the wastage and number of medicines that expired unused; and if she will make a statement on the matter. [17365/25]

Jennifer 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.