Stephen Donnelly (Wicklow, Fianna Fail)
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The 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. The Minister for Health has no role in these decisions. 

Under the legislation, there are formal processes which govern applications for the pricing and reimbursement of medicines and only licensed products are added to the formal GMS Reimbursement List.  Licensing a product requires the manufacturer to submit a dossier to either the European Medicines Agency or alternatively the Health Products Regulatory Authority in Ireland. 

The HSE have advised that Cariban (doxylamine / pyridoxine) is an unlicensed product that is not reimbursable under GMS and Community Drug Schemes. Therefore, the HSE does not intend to reimburse Cariban under Community Drug Schemes or to review the clinical evidence for this unlicensed product.