Malcolm Byrne (Wicklow-Wexford, Fianna Fail)
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350. To ask the Minister for Health in view of the withdrawal of a medication from the Irish market, if other drugs to replace this medication have been approved by the HSE, including (details supplied); and if she will make a statement on the matter. [54456/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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Medicines placed on the Irish market must be authorised by the Irish Medicines Regulator, the Health Products Regulatory Authority (HPRA) or, in the case of centrally authorised products, by the European Commission. There is also a provision for exempt medicinal products, which are not nationally authorised by the HPRA or centrally authorised by the European Commission to be supplied by pharmacists in certain circumstances. EMPs can be supplied in response to a bona fide unsolicited order, formulated in accordance with the specifications of a practitioner for use by their individual patients on their direct personal responsibility to fulfil the special needs of those patients.

Officials in the Department contacted HPRA to seek the most up-to-date information available on the product "alirocumab" and received the following information:

“Alirocumab (Praulent®) is an authorised medicinal product in Ireland. The Marketing Authorisation Holder is registered as Sanofi Winthrop Industrie, 82 Avenue Raspail, 94250 Gentilly, FRANCE. In October 2024, Sanofi confirmed to the HPRA that they had decided to no longer market Praulent in Ireland for commercial reasons.

Evolocumab (Repatha®) is an authorised medicinal product in Ireland. The Marketing Authorisation Holder is registered as Amgen Europe B.V., Minervum 7061, 4817 ZK Breda, Netherlands. Amgen has confirmed to the HPRA that Evolocumab (Repatha®) is currently available for supply to Irish patients and no shortages (of any presentation) are anticipated or ongoing.

The HPRA cannot require companies to market medicinal products in Ireland, and we also have no role in relation to pricing and reimbursement. We would be willing at any stage to engage with and to provide regulatory guidance to any company who wishes to make medicinal products available in Ireland”.