Clare Daly (Dublin Fingal, Independent)
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749. To ask the Minister for Health when the drug C1 esterase inhibitor Berinert will be made available by the HSE to persons with hereditary angioedema. [35981/18]

Simon Harris (Wicklow, Fine Gael)
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The HSE has statutory responsibility for decisions on pricing and reimbursement of medicines in the community drugs schemes, under the Health (Pricing and Supply of Medical Goods) Act 2013.

For a medicine to be considered for reimbursement by the HSE, it must first have a marketing authorisation from the European Medicines Agency (EMA) or the Health Products Regulatory Authority (HPRA), before being assessed under the 2013 Act.

I understand that C1-esterase inhibitor (Berinert) is not licensed for use in Ireland.

Should C1-esterase inhibitor (Berinert) receive marketing authorisation, the company may make an application to the HSE for reimbursement.