Claire Kerrane (Roscommon-Galway, Sinn Fein)
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683. To ask the Minister for Health if supplements (details supplied) will be included under the medical card scheme given that those on waiting lists for transplants rely on such medication. [51186/22]

Stephen Donnelly (Wicklow, Fianna Fail)
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The HSE has statutory responsibility for decisions on pricing and reimbursement of medicines under the community drugs schemes, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013.

HSE decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds, on the advice of the National Centre for Pharmacoeconomics (NCPE). The NCPE conducts health technology assessments (HTAs) for the HSE and makes recommendations on reimbursement to assist HSE decisions. The NCPE uses a decision framework to systematically assess a drug's clinical and cost effectiveness as a health intervention.

Both products, which are not licensed medicines in Ireland, are covered on a patient-specific basis under Discretionary Hardship Arrangements for those who require supplementation as a result of a serious clinical condition. Only licensed products are added to the formal GMS Reimbursement List in line with the Health (Pricing and Supply of Medical Goods) Act 2013. It is a matter for the Marketing Authorisation Holder to apply for licensing in Ireland through the Health Products Regulatory Authority (HPRA).