363. Deputy Seán Ó Fearghaíl asked the Minister for Health if she is aware of concerns raised by patients and families affected by phenylketonuria (PKU) regarding access to a medicinal product (details supplied); if the product has been assessed, or is under assessment, for reimbursement and availability in Ireland; the current status of any application for pricing and reimbursement of this treatment; and the timeline envisaged for a decision on patient access [66142/26]

Under the Health (Pricing and Supply of Medical Goods) Act 2013, the HSE has statutory responsibility for decisions on the pricing and reimbursement of medicines and medical devices; therefore, the matter has been referred to the HSE for attention and direct reply to the Deputy.