Yesterday, at a briefing session in Leinster House hosted by Deputy Billy Kelleher, a powerful presentation was made on behalf of people with cystic fibrosis on the question of access to Orkambi. Jillian McNulty, a 40 year old woman, explained how she spent up to 15 hours a day in bed before going on Orkambi and illustrated how she is now 19 hours on the campaign trail to get Orkambi made available. Rachel Byrne's eight year old daughter Beth has cystic fibrosis and has been hospitalised for quite some time but excels in everything she does in academia and education. She is anxious her daughter gets a chance in life and a chance to contribute effectively to society. Phil Hughes Dunphy's 23 year old daughter Sarah died as a result of cystic fibrosis. Her son Shane also has cystic fibrosis and he has climbed Kilimanjaro. Philip Watt of Cystic Fibrosis Ireland made a very reasonable and moderate presentation.

I have raised this issue on a number of occasions with the Taoiseach. Much is left to be desired in how the situation has been handled on both sides. The Orkambi drug is effective. Last week, the Minister for Education and Skills, Deputy Bruton, acknowledged this. There have been too many attempts to belittle the effectiveness and impact of the drug by the HSE and others-----

That is not true.

Not by us.

-----in terms of not accepting the 40% reduction in hospitalisation and the significant other benefits that flow. This is beginning to move and people are beginning to acknowledge it is an effective drug. The real issue comes down to price. We must put in context that Governments do not make drugs, pharmaceutical companies do.

The drugs in question are called "orphan" drugs because they are developed to deal with rare diseases but, for decades, big pharmaceutical companies have not invested in developing orphan drugs for rare diseases. Governments were shy on that front as well and there were numerous attempts at European level to get critical mass behind the idea of developing drugs for rare diseases. The cystic fibrosis population who might benefit from Orkambi is approximately 500 patients, with 3,000 in the UK, so it is difficult to make back the investment in research and that has to be balanced in the assessment of how to go about this.

In July the Minister announced drug savings of up to €750 million. To cut to the chase, I get the sense that there has not actually been intensive negotiations on this. Deputy Kelleher has had his own meetings and his own discussions with people and one has the sense that it is not being dealt with at a high enough level. There has been too much spinning and too much leaking, which have caused hurt and devastation to the cystic fibrosis population, and it is time for the bad blood to end. The Taoiseach has to get a grip on this and on the Minister to make sure there is intensive engagement between the company and the authorities. If that necessitates international mediation so be it, but something has to be done to break the logjam, the Mexican stand-off, that is the current state of play.

This is obviously a very sensitive and personal issue for those people who have to meet the challenge of cystic fibrosis. Vertex is ripping off the taxpayer and I do not agree that there have not been intensive discussions. I do not agree that there has been an attempt to diminish the impact on quality of life which Orkambi can bring for those patients aged 12 and over who would benefit from it.

It is not a political process that determines the value and the impact of a drug and this has been pointed out by those who are qualified in clinical practice to determine such things on behalf of persons with cystic fibrosis. It is disappointing that the latest round of discussions between Vertex and the HSE have concluded. I trust Professor Michael Barry from the National Centre for Pharmacoeconomics, who said last week that it was time for the company to put patients first and to significantly reduce its price. He said the five-year gross budget impact of reimbursing Orkambi was estimated at more than €390 million and that the centre had noted the significant opportunity cost associated with reimbursing the drug. That is not a political charge but one that comes from people who are qualified to determine these matters in the medical area.

The Deputy seems to be suggesting that the Minister or I should negotiate directly with the company but the Minister for Health, Deputy Harris, has travelled to Lisbon today and has written to his fellow Ministers in Australia, Canada, England and Scotland, where the medicine has also not been approved. He is seeking co-operation with these countries and to join forces to impact positively on and influence the manufacturer to accept other innovative pricing approaches to significantly reduce the cost of this medicine. There are those within the cystic fibrosis community for whom Orkambi does not work and, even were Vertex to reduce the cost in line with the assessed proportion for whom it does not work, there would be a significant reduction in the cost of the drug.

Things have moved on from the days when the political process made a determination as to the value of a drug in terms of quality of life. We all empathise with and understand the sensitivities associated with this but this company is using cystic fibrosis patients. It has a drug which enhances quality of life but there is a percentage for whom it does not work and the charge being put forward by the company is grossly excessive, as determined not by a political process but by a clinical professor in charge of this who has been very clear about the situation regarding this company.

I urge the company to return to the intensive discussions that have already taken place and reduce the price. Then we can move on and those whom the drug will benefit will have the benefit of it.

I disagree. I do not want the Taoiseach to get involved in negotiations. I want him to ensure proper, intensive negotiations take place. Since 2012, 32 new cancer drugs have been approved in Ireland. However, during the past 20 years only two new drugs have been developed for cystic fibrosis. One is Kalydeco and the other is Orkambi, which has not been approved. We are not comparing like with like. Globally, the Cystic Fibrosis Foundation offered $75 million to the pharmaceutical world to start developing cystic fibrosis drugs. The top ten pharmaceutical companies rejected the offer. Only Vertex took it up. I am not here to advocate for any company.

The easy thing to do politically is to attack big, bad pharma. It is a great political line. However, it does not resolve this. I have spoken to Deputy Billy Kelleher, who has spoken to people on all sides here, and I am not clear that intense negotiations have taken place. A figure of €30,000 has been thrown out. Nobody but those who threw the figure out believes €30,000 is a runner for a drug developed for a rare disease. It could be a bridge to a cure, which must be the ultimate objective of research and development.

I do not think this has been handled well. It is not good enough that the cystic fibrosis population should read about the outcome of negotiations on the front page of a Sunday newspaper and receive a tweet late on a Saturday night. This is the context, and there is bad blood. I did not like what I saw being argued publicly. A deal cannot be made if there is just hostility and bad blood between the two sides. That is no basis for resolving it. There is an issue with a rare disease globally. We have a huge problem. We must break the logjam and I do not believe there has been a realistic attempt to do it. I would like to get the evidence that there has been.

I do not agree with the way the Deputy has done down the negotiating skills and clinical skills of Professor Michael Barry.

He is not negotiating.

He is not negotiating. It is a senior official from the HSE. The Taoiseach should not personalise it. That is not the issue.

He has pointed out that the National Centre for Pharmacoeconomics, NCPE, which undertook an assessment of Orkambi, noted from a clinical point of view that the drug was not considered cost-effective in terms of quality of life for the people involved at almost €160,000 per patient per year, as submitted by Vertex. The NCPE estimated the cost-effective price at €30,000. There is a big difference between €30,000 and €160,000. It is in there that realism needs to-----

The company says it has come way down. I do not know whether or not it has.

I did not hear the company say it had come way down.

It has said it publicly.

I did not hear it say that. If the company is prepared to come a way down from €160,000 per year per patient, let us see what it is talking about. The NCPE estimates the cost-effective price at €30,000 per patient; the NCPE will be flexible with realism. However, I very strongly believe in what Professor Barry has pointed out, which is that the price estimated by the company is grossly excessive.

The Minister for Health, Deputy Simon Harris, has said that Vertex wants to meet with him and the HSE. The HSE is open to this and there will be realistic discussions with no animosity. The company has come in here, as it did in Australia, Scotland, England and Canada, where it was not approved on the public health bill. The price is excessive. If Deputies Micheál Martin and Billy Kelleher say the company is prepared to come way down, let us see the colour of its step. The HSE will be flexible in respect of the cystic fibrosis patients and will treat it with realism, but not at this cost.

Notwithstanding the vital importance of the issue, we must operate to time limits that are set not by me but by the House. If people completely disregard the time limits, we are going nowhere fast.

Tá mé ag cur an ceist céanna. As the Taoiseach knows, the island of Ireland has the highest number of people in the world suffering from cystic fibrosis and the largest proportion of families with more than one child who suffers from the condition. According to Cystic Fibrosis Ireland, it affects around 1,200 adults in the State and citizens here suffer some of the most severe strains of the disease. There are also 455 citizens with cystic fibrosis in the North. In the past few weeks Oireachtas Members have heard two heartbreaking and emotional presentations, one hosted by Teachta Louise O'Reilly, made by citizens living with cystic fibrosis and their family members. We have heard from parents who have buried children and those who manage gruelling daily medical regimes and endure recurrent hospitalisation. Many of them are battling valiantly to be given the opportunity to access the potentially life-changing drug, Orkambi. Let us take the case of Finn Whitmarsh whose family members are living in fear that they will not be able to access the treatment that would give him a new quality of life. For Finn and his parents, Linda and Ronan, drugs like Orkambi have the potential to keep him well and assist in managing his condition. Finn is two and a half years old and has been hospitalised 38 times. Cathal Gallagher is nine years old and his health was good until recently. He has developed lung issues. The medication he is taking has affected his liver which has been permanently damaged. He is featured on the #YesOrkambi mural on the quays in Dublin. Only 40 citizens have been able to secure Orkambi on a trial basis, of whom Jillian McNulty is one. I asked her how patients were chosen and she said it was the luck of the draw.

I have asked the Minister for Health, Deputy Simon Harris, numerous questions about where the negotiations on Orkambi and other drugs stand, but we are none the wiser, as he has not told us. The families have requested six times to meet him. Will the Taoiseach ask him to meet them as a priority? Some of them were told recently by Vertex that it was open to a risk-sharing model of payment, among other payment schemes. I was not sure if I heard the Taoiseach properly a moment ago when he appeared to say Vertex was ripping off the taxpayer. That is what he said. I checked with my colleague. It is an extraordinary allegation and begs the question that if he is saying the company is ripping off the taxpayer, what is he doing about it? Will he confirm if all options have been pursued with Vertex? I understand the Minister is in Lisbon today. I agree absolutely that a collaborative approach could lead to significant reductions in prices and commend that approach. While the Minister in the North, Ms Michelle O'Neill, has no direct responsibility in the matter, she has indicated a willingness to work with the Minister here to assist in the process. Will the Taoiseach commit to formally approaching counterparts in the Assembly and other EU member states as part of a collaborative discussion to secure access to Orkambi? Will he tell us what he will do following his allegation that the company is ripping off the taxpayer, while citizen patients suffer?

Action is already being taken because the drug is not available in the public health systems in Australia, Canada, England and Scotland.

It is available in Austria.

It is true that Ireland has the highest incidence of cystic fibrosis of many countries, if not in the world, but there are those who suffer from cystic fibrosis in other countries also and the drug is not available in their public health systems either. The Minister for Health has written to their Ministers seeking joint co-operation to talk sense to the company. It is not I who says Vertex is ripping off the taxpayer. The clinical professor dealing with the issue says, from his experience, expertise and understanding of its impact on people's quality of life, the cost of the drug is not justified at €160,000 per patient per year. If we now hear, based on the analysis of Deputy Billy Kelleher, whom I respect for his work, that the company is prepared to come back down from the €160,000 charge, Deputy Gerry Adams should believe me when I say the HSE and the Minister are more than willing to be flexible in the interests of those for whom the drug may well be of benefit.

The point made about the excessive charge levied by the company comes from a person who is in charge of the NCPE and has pointed out that this is not value for money for the taxpayer. Given the charge, people who need and may benefit from the drug will not have it made available to them.

It is not only in Ireland that the company is operating in this way. It is taking the same approach in Australia, Canada, Scotland and England. The Minister, Deputy Harris, is going to Lisbon to talk to his fellow Ministers and work jointly with the manufacturer in order to bring realism to the pricing structure.

We will work with the Executive in Northern Ireland and Ministers for Health in other countries to whom the Minister, Deputy Harris, has written in the hope that the manufacturer will see sense and bring the drug to Ireland in order to relieve patients who can benefit.

I welcome the Taoiseach's remarks that he will work with others, including the Minister in the North. However, the Government does not have a good record in standing up to elites.

I met many people affected by this a number of weeks ago. The one thing that they all have in common is hope - it is probably part of the human condition that in adversity we all have hope. Their hope springs from the possibility that they can access this life-changing drug and, it is to be hoped, newer drugs in the future which can provide a cure. However, there is a pricetag involved and it seems, as someone more eloquent than I once said, we know the price of everything and the value of nothing.

Everything is dependent on negotiations with pharmaceutical companies. People do not have the time for that. There is a need for clear information to be given to the families involved, transparency, collaborative negotiations and access to drugs like Orkambi.

Yesterday, one mother, Mrs. Dunphy, told us she had lost one child to cystic fibrosis and does not want to lose another. She held a photograph of a beautiful young woman as she said that. There is a real urgency about the provision of this drug.

I ask the Taoiseach to consider a proposition. Will he give a commitment to the families who are candidates for the drug that they will receive it while negotiations are ongoing, even on a trial basis?

The answer to the Deputy's last question is that the company can make the drug available to those persons who might benefit from it if it so wishes. The drug is not available in the Irish public health system because of the excessive charge being levied by Vertex.

I accept that transparency and collaborative negotiations are necessary. Why does Deputy Adams think that the Minister, Deputy Harris, wrote to his fellow Ministers in other countries where the drug is not available in their public health systems? He did so in order that they can get together, talk sense to the company and tell it X number of people in a given country suffer from cystic fibrosis whose quality of life would be enhanced by this drug. There are a percentage of people in Ireland aged over 12 years for whom it would not be of any benefit.

The decision was made by the clinical professor involved; it is not just a political decision. It is not a case of directing the company to reduce its charge. Rather, as the Deputy said, collaborative negotiations and transparency are required.

The point made by Professor Barry, who is an expert in this field, is that the charge being levied by the company is grossly excessive and it should retreat from that. The Minister and I have already said that the HSE and the Department are prepared to negotiate with realism. I hope collaborative negotiations with other Ministers for Health will bring a sense of realism to the company. We congratulate it on having manufactured the drug. We need to be able to give it to those whom it would benefit, but not at any price.

That was said two years ago.

The Minister of State is sitting on the fence.

Deputy Dooley knows I do not sit on the fence.

Can we have silence, please? I call Deputy Pringle.

Muscle up, Finian. You are in government.

Deputy Dooley need not worry.

You are on the high chair, Finian.

Will Deputy Dooley restrain himself, please? I call Deputy Pringle.