Dáil Éireann Debate, Tuesday - 18 April 2023
1456. Deputy Duncan Smith asked the Minister for Health whether or not “unlicensed medicines” in pharmacies for medication where the regularly prescribed medication is unavailable (details supplied) are covered by the medical card, in this instance, an “unlicensed alternative” for the medicine; and if he will make a statement on the matter. [16780/23]
View answerThe Health Service Executive (HSE) has statutory responsibility for medicine pricing and reimbursement decisions, 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 reimbursement list. Reimbursement is for licensed 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 (NCPE). I, as the Minister for Health, have no role in these decisions.
The HSE advise that where a licensed product is not available to those with medical card eligibility and there are no suitable therapeutic alternatives on the GMS Reimbursement List, an individual application can be made for reimbursement support through Discretionary Hardship Arrangements for the unlicensed formulation with the same active ingredient.
