Frank Feighan (Sligo-Leitrim, Fine Gael) | Oireachtas source

I thank Senator Keogan for raising this issue. Cystic fibrosis is a devastating disease for patients and their families. With Ireland having one of the highest per capitarates of cystic fibrosis in the world, many of us will have been affected by the sadness it can cause for families. Access to effective treatments offers hope to those suffering from this disease, and I aim to make this possible for every patient who needs it.

Kaftrio has been a life-changing drug for cystic fibrosis sufferers. Access to drugs like this was what we expected when the HSE signed the agreement with its manufacturer, Vertex, in 2017. The deal stipulated that our patients would have access to Vertex's entire portfolio of cystic fibrosis drugs for a capped yearly cost. We made a ten-year commitment that 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, the HSE would receive access at no additional cost. This has been the case previously when new indications were licensed. The agreement was amended in 2019 and 2020 to include these patient groups at no additional cost. However, for this particular subtype, affecting a small group of children, Vertex is requesting additional funds to provide access.

The HSE has statutory responsibility for the community drug schemes. It has structures in place to ensure that our health service is able to provide the right care sustainably. Its CPU has engaged extensively with Vertex - holding ten meetings - to try to see this patient group included in our pre-existing agreement. Considering the significant budgetary impact of the additional resources Vertex is requesting, it must engage with the pricing and reimbursement process that all other medicines are required to undergo.The HSE continues to engage proactively with Vertex, having met as recently as 16 September, 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 patients, and budgets 2021 and 2022 saw €80 million in funding dedicated to new medicines. A total of 90 new medicines, or the expanded use of existing medicines, were made available by this funding, 21 of which related to the treatment of rare diseases.

I thank Cystic Fibrosis Ireland for its efforts in bringing attention to this matter. The event it held outside Leinster House last month helped raise awareness among the public and my colleagues in the Oireachtas. The dedication of the organisation's members is admirable. We share the common goal of making this drug available to the children who need it, and the Minister is eager to gain their insight on possible routes to a solution. To that end, his office has been in contact with them to arrange a meeting in the coming weeks and he looks forward to hearing their ideas and making progress on this issue.

As Senator Keoghan outlined, access for these 35 children and their families has been denied. I hope that through all the various stakeholders, the Minister's office, Cystic Fibrosis Ireland, the pharmaceutical companies and perhaps even the Senator, we can get a resolution to this difficult and complex issue.