A number of parents are listening to this debate. What they will want to know is when their children will get access to the drug Kaftrio. There are 35 children being denied a drug that is hugely beneficial to treat their cystic fibrosis, CF. They will be asking questions of the HSE and the manufacturer, Vertex. A resolution has to be found immediately. It is unbelievable that others living with CF have access to this drug. It is hugely beneficial. Even in Europe, the vast majority of people living with cystic fibrosis have access to it. These parents and children are being denied and delayed. That is a terrible injustice for these children. I understand the Minister for Health will be meeting with some of the parents next week regarding this cohort of children. It is disappointing that the meeting has not taken place thus far. There is huge frustration and anger about this situation. I always try to put myself in the shoes of a parent of a child with CF. Imagine knowing there is a medication that is being denied to your child. That is immoral. I am sure the Minister of State and everybody else will agree with that, given that a drug is available to people but these children cannot get it because of what seems to be a price dispute between the HSE and Vertex. A resolution has to be found. No financial burden should be put on parents and children at this stage. There is speculation that this could be referred to the National Centre for Pharmacoeconomics, NCPE. That is an arduous and lengthy process, to say the least, that could go on for well beyond three months. Time is of the essence for access to Kaftrio. I hope the Minister of State will have some news today for the 35 parents who are listening and seeking access for their children.

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 capita CF 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.

I do not blame the Minister of State, but if I was a parent of a child listening to this, I would believe the fault lies with the manufacturer, Vertex. That is not disputable. It is also not disputable that Vertex is a multi-billion dollar enterprise, so much so that I looked up its listings on how much it makes per year. To say it is eye-watering is an understatement. It has a stock valuation of $70 billion. Its turnover two years ago just for the drug Kaftrio was $5.7 billion. Two years ago, it made a profit of $4.3 billion. It is incredible the amount that a pharmaceutical company can make and at the same time go into a dispute with, and almost blackmail, governments around the access to this drug. It is absolutely immoral that pharmaceutical companies, most of which are based in Ireland, have governments and families over a barrel. They make an amazing profit, but the Minister of State said in her statement that they are looking for extra funding. I am sure they have done very well out of the Irish State just with this particular drug. They have made tens of millions of euro in profits but they will not compromise on this issue. The Minister of State must agree that it is absolutely immoral. I do not know how these people sleep at night while at the same time children are being denied this drug. In one guise Kaftrio is being hailed as the closest thing to a cure for those with CF, yet this is being denied to children. It is absolutely immoral. Hopefully, the Minister can convey this sentiment to the CEO of Vertex.

I thank the Deputy for raising this important issue. I certainly will bring this back to the Minister. It is unfortunate that Vertex reneged on its commitment and agreement. It is highly frustrating for the Government and for the HSE to be in this particular position. There are 35 families possibly looking in here this morning and looking for hope. I hope that when the Minister meets with the CEO, with the clinical experts and with the patient representatives, there will be a positive outcome from the meeting. It is unfortunate that when one hears of a drug company reneging on its ten-year agreement, it puts other rare diseases at risk. It is important also to ensure that Mazars' report is published, which was our report. This review into how we do business on the licensing and funding of rare drugs is such an important piece in protecting and ensuring that people have access to rare drugs. This is why that relationship cannot be undermined and cannot break down. There must be a positive relationship between the HSE, the Government, and the drug companies to ensure that people and children who get rare diseases have access to drugs in a timely fashion. I will bring this issue back to the Minister.