Anne Rabbitte (Galway East, Fianna Fail) | Oireachtas source

I thank the Deputy for raising this issue, to which I am responding on behalf of the Minister for Health. Cystic fibrosis is a devastating disease for patients and their families, with Ireland having one of the highest per capitaCF rates in the world. Many of us will have seen its effects and the cost to families. Access to effective treatment offers hope to those suffering from this disease and the Minister aims to make this possible for every patient who needs it.

Kaftrio has been a life-changing drug for CF sufferers. Access to drugs like this is what we expected when we signed our agreement with the manufacturer Vertex in 2017. The deal stipulated that our patients would have access to Vertex's whole portfolio of CF drugs for a capped yearly cost. We made a ten-year commitment, which has already seen us pay hundreds of millions of euro to Vertex. We entered this agreement in good faith, expecting that as new licences were approved for its medicines, we would receive access at no additional cost. This has been the case previously when new indications were licensed. Our agreement was amended in 2019 and 2020 to include these patient groups at no additional cost. However, for this particular subtype affecting a small number of children, Vertex is requesting additional funds to provide access.

The HSE has statutory responsibility for community drug schemes. It has structures in place to ensure our health service is able to provide the right care suitably and sustainably. The corporate pharmaceutical unit has engaged extensively with Vertex, holding 11 meetings to try to get this patient group included in our pre-existing agreement. Considering the significant budgetary impact of additional resources, Vertex is requesting it engage with the pricing and reimbursement process that all our medicines are required to undergo. The HSE continues to engage proactively with Vertex, meeting as recently as 12 October, hoping to better understand why the company has chosen to take this position. The Government is committed to providing access to innovative new medicines for Irish patients.

The last three budgets have seen almost €100 million dedicated to new medicines, with 90 new medicines or the expanded use of existing medicines made available by this funding, and 21 of these are for the treatment of rare diseases. The Irish Pharmaceutical Healthcare Association, IPHA, a group representing the industry, has described this dedicated funding as a game-changer. The Minister thanks Cystic Fibrosis Ireland for its efforts in bringing attention to the situation. He shares a common goal of making this drug available to the children who need it. The Minister is eager to gain their insight on possible routes to a solution. To that end, he will meet with the CEO soon. This meeting will include clinical experts and patient representatives. I hope this is the meeting that the Deputy referred to as being next week. It is a timely meeting giving a voice to those with real-world experience of this debilitating disease and the difference that Kaftrio could make. The Minister is optimistic that their meeting will be fruitful and will contribute to making this drug available to every person who needs it.

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