Colm Burke (Cork North-Central, Fine Gael)
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2098. To ask the Minister for Health her views on whether a review of the pricing and reimbursement system by an organisation (details supplied) adequately considers the recommendations set out in the 2018 Oireachtas health committee Report on Evaluating Orphan Drugs; and if she will make a statement on the matter. [19255/25]

Colm Burke (Cork North-Central, Fine Gael)
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2099. To ask the Minister for Health if the recommendations set out in the 2018 Oireachtas health committee Report on Evaluating Orphan Drugs will be implemented in the context of the programme for Government commitment to review the medicines reimbursement process; and if she will make a statement on the matter. [19256/25]

Colm Burke (Cork North-Central, Fine Gael)
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2100. To ask the Minister for Health when the programme for Government commitment to review the medicines reimbursement process will commence; who will be responsible for overseeing the review; and if she will make a statement on the matter. [19257/25]

Colm Burke (Cork North-Central, Fine Gael)
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2101. To ask the Minister for Health if work has commenced in drafting the terms of reference for the programme for Government commitment to review the medicines reimbursement process; if the terms of reference for this review will make provision for specifically considering the rare disease perspective; and if she will make a statement on the matter. [19258/25]

Colm Burke (Cork North-Central, Fine Gael)
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2102. To ask the Minister for Health the steps that will be taken to ensure that the rare disease perspective is specifically considered in the context of the programme for Government commitment to review the medicines reimbursement process; whether a consultation process will be carried out to seek the input of rare disease patients and other relevant stakeholders in the conduct of this review; and if she will make a statement on the matter. [19259/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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I propose to take Questions Nos. 2098 to 2102, inclusive, together.

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 State is committed to providing timely access to new and innovative medicines to all patients. Budgets 2021 to 2024 allocated an additional €128 million for new medicines, which has facilitated the introduction of 194 new medicines including 49 new orphan medicines for rare diseases. Budget 2025 allocated €30 million for new drugs to come from efficiencies to be identified by the HSE. Efficiencies such as these have been identified as a priority for 2025 by the Minister, with the joint HSE-Department of Health Taskforce addressing medicine expenditure.

The timing of company applications for new medicine reimbursement in different countries can vary for several reasons, not least the available market share in each country.

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. 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. Ireland encourages all marketing authorisation holders to apply for reimbursement once marketing authorisation for a new medicine or new indication is granted by the European Medicines Agency.

Reports describing timelines for reimbursement from EMA approval to HSE reimbursement approval do not consider this important factor and misrepresent the process, as statutorily the HSE are not able to add a new medicine to the reimbursement list until an application is received.

The previous Minister for Health published the ‘Mazars Review of the Governance Arrangements and the Resources currently in place to support the Health Service Executive reimbursement and pricing decision-making process’ in 2023 which found that the HSE Pricing and Reimbursement system was operating as intended and within international norms.

On foot of this several rounds of engagement took place with stakeholders including patient organisations and industry. 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.

In addition, the HSE introduced a medicine’s application tracker to support transparency in the reimbursement process. 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 will continue the tracker’s development with the introduction of indicative timelines for each step of a medicine’s assessment process in compliance with NSP 2025.

The National Rare Disease Steering Group will shortly complete its work on a new National Rare Disease Strategy for my consideration.