James Lawless (Kildare North, Fianna Fail)
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471. To ask the Minister for Health the reason that hormone replacement therapy has been taken off the drugs payment scheme; and if he will make a statement on the matter. [44408/22]

Stephen Donnelly (Wicklow, Fianna Fail)
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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 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 licenced indications which have been granted market authorisation by the European Medicines Agency or the Health Products Regulatory Authority.

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 by the taxpayer are made on objective, scientific and economic grounds, on the advice of the National Centre for Pharmacoeconomics. The HSE Reimbursement list is the same for the General Medical Services (GMS) scheme and the Drug Payment Scheme (DPS).

Therefore, some hormone replacement therapy (HRT) medications are available to medical card holders under the GMS scheme, subject to the statutory prescription charge. These same HRT medications are also available under the DPS, which ensures that no individual or family pays more than €80 a month towards the cost of approved prescribed medicines.