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Medicinal Products

Dáil Éireann Debate, Tuesday - 14 October 2025

Tuesday, 14 October 2025

Questions (805)

Michael Healy-Rae

Question:

805. Deputy Michael Healy-Rae asked the Minister for Health if a medication on which a person (details supplied) is dependent which is in short supply and is currently not in stock could be accessed alternatively; and if she will make a statement on the matter. [54595/25]

View answer

Written answers

The Health Service Executive (HSE) has statutory responsibility for decisions on pricing and reimbursement of medicines and medical items, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013.

In line with the 2013 Act and the national framework agreed with industry, a company must submit an application to the HSE to have a new medicine added to the formal Reimbursement list. Reimbursement is for licensed indications which have been granted market authorisation by the European Medicines Agency (EMA) or the Health Products Regulatory Authority (HPRA).

In making a relevant reimbursement decision, the HSE is required under the Act to have regard to a number of criteria including efficacy, the health needs of the public, cost effectiveness and potential or actual budget impact. HSE decisions on which medicines are reimbursed are made on objective, scientific and economic grounds, on the advice of the National Centre for Pharmacoeconomics (NCPE).

The Department is aware of the stress that shortages of medicines can cause for patients and healthcare professionals alike, thusly managing and mitigating medicine shortages is the subject of several workstreams across the Department and wider health service.

Ireland has a multi-stakeholder Medicines Shortages Framework in place, operated by the medicines regulator, the HPRA, on behalf of the Department of Health. The framework aims to help prevent potential shortages from occurring and to reduce the impact of shortages on patients by coordinating the management of potential or actual shortages as they arise.

The HPRA maintains a list of current and resolved shortages on its website. The webpage is updated daily as the HPRA receives new information.

In relation to the cost of medicines, people who cannot, without undue hardship, arrange for the provision of medical services for themselves and their dependants may be eligible for a medical card under the General Medical Services (GMS) Scheme. Possession of a medical card entitles people to access to prescribed medicines subject to the payment of a small prescription charge.

In accordance with the provisions of the Health Act 1970 (as amended), eligibility for a medical card is determined by the HSE.

In certain circumstances the HSE may exercise discretion and grant a medical card, even though an applicant exceeds the income guidelines, where he or she faces difficult financial circumstances, such as extra costs arising from illness. In circumstances where an applicant is still over the income limit for a medical card, they are then assessed for a GP visit card, which entitles the applicant to GP visits without charge.

Under the Drugs Payment Scheme (DPS), no individual or family pays more than €80 a month towards the cost of approved prescribed medicines. The DPS is not means tested and is available to anyone ordinarily resident in Ireland. The DPS significantly reduces the cost burden for people with ongoing expenditure on medicines.

There has been a significant focus on improving access to and the affordability of healthcare services over the last few years. This includes reductions in the DPS threshold, expansion of access to free GP care, and the abolition of all public in-patient hospital charges for children and adults. These measures continue to create a health and social care service that offers affordable access to quality healthcare.

Individuals may also be entitled to claim tax relief on the cost of their medical expenses, including medicines prescribed by a doctor, dentist, or consultant. Relief is at the standard tax rate of 20%.

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