I move:

That Seanad Éireann:

notes:

- that the process for approving new medicines is set down in law, the Health (Pricing and Supply of Medical Goods) Act 2013 and is not a ministerial function;

- that the manufacturer of Orkambi has yet to make a full application for reimbursement to the Health Service Executive;

- that no decision on funding can be made until a full health technology assessment is carried out and a recommendation is made by the National Centre for Pharmacoeconomics;

- looks forward to Orkambi being made available for cystic fibrosis patients who will benefit from it, once the normal approval procedure, as with other high-tech medicines, is completed and an appropriate fair price negotiated with the manufacturer.