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Written Answers — Department of Health: Medicinal Products (28 Nov 2023)

Stephen Donnelly: ...to take Questions Nos. 595, 597, 598 and 599 together. The Health Service Executive (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. The HSE is committed to providing access to as many medicines as possible, in as timely a fashion...

Written Answers — Department of Health: Medicinal Products (28 Nov 2023)

Stephen Donnelly: ...reimbursement from EMA approval to HSE reimbursement approval does not consider this important factor and misrepresents the process, as statutorily the HSE would not be able to approve or assess a drug until an application for reimbursement was received. When an application is made to have a product added to the reimbursement list in Ireland, the HSE is required, under the 2013 Act,...

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