Bernard Durkan (Kildare North, Fine Gael)
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295. To ask the Minister for Health the total number of rare and orphan drugs currently being evaluated for use in Ireland; the length of time that normally required for this process; the drugs that have taken an inordinate amount of time to evaluate and approve for use here; and if he will make a statement on the matter. [62832/22]

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.

Colm Burke (Cork North Central, Fine Gael)
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296. To ask the Minister for Health if the 35 children with cystic fibrosis whose age and genotype were not included in the initial deal with a drug manufacturer will now be included to provide access to the life changing medication, kaftrio (details supplied); and if he will make a statement on the matter. [62834/22]

Stephen Donnelly (Wicklow, Fianna Fail)
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Kaftrio has been a life changing drug for Cystic Fibrosis sufferers, and I want to see it made available to everyone who needs it. This Government wants to ensure greater access to new and innovative medicines and has allocated significant additional funding for new medicines in recent Budgets. Since the beginning of 2021, 99 new medicines, or expanded uses of existing medicines, have been funded. This has included 27 for the treatment of rare diseases, including Cystic Fibrosis.

The HSE has statutory responsibility for decisions on pricing and reimbursement of medicines under the community drugs schemes, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013.

I am grateful to Cystic Fibrosis Ireland (CFI) for meeting with me recently, and outlining the concerns of the Cystic Fibrosis community. We discussed the recent statement from the Consultants providing care for these children, with all parties aligning in the view that the approach taken by the manufacturer, Vertex, is unfair to these children. I reassured CFI of the urgency with which the Government and the HSE are approaching the current situation.

I have been advised by the HSE that engagement with Vertex Pharmaceuticals is ongoing, which I hope can be quickly brought to a satisfactory conclusion for everyone.