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Clinical Trials

Dáil Éireann Debate, Tuesday - 23 June 2026

Tuesday, 23 June 2026

Ceisteanna (676)

Pádraig O'Sullivan

Ceist:

676. Deputy Pádraig O'Sullivan asked the Minister for Health the guidance that has been issued to Irish marketing authorisation holders regarding the process, timelines, and expectations for considering the EU's Joint Clinical Assessment (JCA) by the HSE and the National Centre for Pharmacoeconomics (NCPE); the way in which JCA reports will be factored into the reimbursement recommendations for treatments; and if she will make a statement on the matter. [46927/26]

Amharc ar fhreagra

Freagraí scríofa

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.

Roinn