Stephen Donnelly (Wicklow, Fianna Fail)
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I propose to take Questions Nos. 1605 and 1607 together.

The Health Service Executive (HSE) has statutory responsibility for medicine pricing and reimbursement decisions, in accordance with the Health (Pricing and Supply of Medical Good s) Act 2013. Only licenced indications which have been granted market authorisation by the European Medicines Agency (EMA) or the Health Products Regulatory Authority (HPRA) can be added to the formal reimbursement list.

From January 2023, Cariban, which at the time was unlicensed in Ireland, was made available under an exceptional arrangement for specific patients who met the criteria, in accordance with the following circular: www.hse.ie/eng/staff/pcrs/circulars/pharmacy/pharmacy-circular-001-23-cariban.pdf.

The HSE were asked to review the exceptional arrangement for the reimbursement of Cariban early in 2023. The review was completed and returned to the Department in September 2023. The review included consultation with clinical leads, the HSE’s Primary Care Reimbursement Service (PCRS), and relevant advocates.

Following the review, applications for reimbursement support for Cariban which are signed by a doctor under the lead Consultant within the maternity hospital will be accepted by PCRS. Thereafter, repeat prescriptions for Cariban can be made by the patient's GP.

Stephen Donnelly (Wicklow, Fianna Fail)
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As this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.