Ireland has one of the most severe strains of cystic fibrosis in the world and the highest incidences per head of population at three times the rate in the United States and the rest of the European Union. In that context, Ireland should be at the forefront of new technologies, research and strategies to deal with the condition. A ground-breaking new drug has arrived on the market. It was approved by the Food and Drug Administration in the United States as far back as July and has also been approved by the European Union. It is called Orkambi and has been described as a game changer in the treatment of cystic fibrosis. It can lengthen life, will improve quality of life and effectively reduce the number of hospital admissions for cystic fibrosis patients by 40%. It would benefit about 60% of cystic fibrosis patients in Ireland as it is very effective in treating the most common cystic fibrosis gene alteration in Ireland - delta-F508. It is a dramatic and game changing drug. However, the response of the authorities in the health service plan and that of the Government is that no funding will be made available in 2016 to provide the drug for cystic fibrosis patients. The HSE is clear that if the Government wants to fund it, it will have to provide it with additional money. We note that in the health service plan there is to be no increase in the high-tech fund in 2016. The plan talks about it being dependent on the HSE in containing new drug approvals. The entire emphasis is on containing rather than looking for an opportunity to dramatically change the quality of life of people with cystic fibrosis. Will the Government provide the necessary funding to ensure the 60% of cystic fibrosis patients who would benefit from the use of Orkambi will be able to benefit from it during the course of the next few months?
It is not about containment. The HSE service plan, as submitted to the Minister for Health and presented by him to the Cabinet, is based on over €800 million extra - almost €13 billion in total - being put into the health service. This means that services will be maintained and that €100 million has been left aside for new, additional and targeted services.
The Deputy makes the point that Orkambi lumacaftor-ivacaftor is a new drug that has come on the market for the treatment of cystic fibrosis. The HSE has statutory responsibility for decisions on the pricing of drugs and the reimbursement of medical products under the community drugs schemes in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013. Decisions on which medicines are reimbursed by the taxpayer are not political and not ministerial. They are made on objective, scientific and economic grounds by the HSE on the advice of the National Centre for Pharmacoeconomics, NCPE. This is a combination drug for the treatment of cystic fibrosis, with two copies of a specific CF gene mutation. The drug was approved by the Food and Drug Administration in the United States on 2 July and the European Medicines Agency three weeks ago on 19 November. On 26 November the manufacturer of Orkambi submitted a rapid review application to the NCPE. The rapid review represents the first step in making a pricing and reimbursement application. As of Friday, 4 December, the manufacturer had not submitted a full application for reimbursement to the HSE. However, based on pricing details in the rapid review file, the HSE estimates that the reimbursement could cost approximately €90 million per year. Given the significant budgetary impact, the NCPE is likely to require a full technology assessment of the drug to be carried out before making any recommendation to the HSE on reimbursement, in keeping wtih the normal procedure.
The Department and the HSE have made significant improvements to the facilities for CF sufferers around the country, particularly isolation units, which add greatly to their comfort and meet their needs. This matter is part of the application process which has a journey to travel.
The Taoiseach is not being straight with the people on this issue. He is hiding behind the NCPE and the HSE. The bottom line is that there is no provision of extra money for the high-tech drugs scheme next year, despite the rapidly escalating cost of treatment, which we acknowledge. However, there is no plan or vision on this issue. Last Sunday the director general of the HSE said categorically that there was no money included in the plan, that the Government had not provided any money and that the health service plan approved by the Government had not provided for any money to be made available in 2016 for this drug. That is the reality. The policy under the health service plan is to contain approvals, in other words, to try to hold them back.
The Food and Drug Administration in the United States went through a very rapid process because this drug was a game changer. It is an orphan drug in the United States and making a huge difference. Ms Jillian McNulty is a campaigner in Ireland who took part in the clinical trial. She said:
Within a few months, my body started changing, during my runs I could breathe deeper, it's not something I can explain correctly because I don’t think I've ever known what it's like to breathe properly.
She said this in a letter that she sent to about 30 Senators and Deputies. Having come off the clinical trial, she immediately saw the impact the drug had on her body and health. Cystic Fibrosis Ireland has written to the Minister outlining the benefits of the drug. It is the first drug to impact on the underlying causes of the condition for 60% of the cystic fibrosis population in Ireland. It has resulted in a 40% reduction in the number of hospital admissions and a sustained increase in lung function and weight, which is a major issue. The Government should stop hiding behind the HSE and the NCPE on this issue and start to have some vision and plan for the game changing new technologies now and in the future. The answer is not a nil increase in the provision in the high-tech budget for 2016. That is not the vision required to deal adequately with this issue and reduce the anxiety CF patients feel because of the statement made by the director general. He said he was being honest, that he did not have the money and would not have it under the health service plan. The Government must make a decision. Will it provide the money in 2016 - yes or no?
The Deputy has not changed. It is the same old mantra. Perhaps he did not hear me the last time. What I said was that decisions on medicines to be reimbursed by the taxpayer were not political or ministerial. They are made on objective, scientific and economic grounds by the HSE on the advice of the NCPE. The Deputy is a great man to talk about his vision.
Will Deputies please remain quiet?
Deputy Micheál Martin is a great man to speak about vision. He set up the HSE-----
The Taoiseach is playing politics with CF patients again. People are fed up of his shallow, empty sloganeering.
He did it five years ago. He has sloganed his way through health and told untruths about it and he is at it again now. He should speak to the issue and be a man and tell the people whether he is going to provide the money or not.
Fianna Fáil destroyed the country.
Would Deputy Martin show some respect for the House?
The Deputy can give it but he cannot take it. His vision as espoused by his spokesperson on health this morning------
The Taoiseach promised universal health insurance but he is not delivering.
The Deputy should hold on and allow the Taoiseach reply.
I was trying to help the Taoiseach.
I was trying to remind him of his broken promises.
-----was to have a situation where it is possible to invest in health services yet Fianna Fáil wants to abolish water charges------
I said nothing about that.
What about the trolleys? What have water charges got to do with it?
What about the cystic fibrosis sufferers?
-----property tax, and take back the taxes people are going to get back in January-----
The Government has spent €1 billion on Irish Water.
How are the eircodes going?
-----with the abolition of the universal social charge.
Deputy Martin expects me here to engage in commercial negotiations about this very important drug. He wants to make political play of cystic fibrosis sufferers. This is a matter-----
I do not.
Yes he does.
We had a policy on this and this Government changed it. It should be leading on this.
What about the scandal of the trolleys?
Deputy Martin did not do much when he was in government.
Deputy Martin can give it out but he cannot take it.
We have the most CF patients in the world and we should be leading on this.
The Deputy expects commercial negotiations-----
The Government could have a vision for this.
-----about this drug to take place in this House. He knows from his experience, if he has any responsibility from his time as Minister for Health, that these negotiations are conducted with the national clinical programme, NCP.
We brought in high-tech drugs quickly during our time and changed the nature and treatment of many diseases as a result. This Government has taken the opposite approach.
The Deputy knows that but he does not want to admit it. I am not hiding behind anybody. This is a matter that is dealt with in a very particular way. This application is in the process of going through the system.
The Taoiseach should get up on the lorry. It is probably waiting outside for him.
Does the Taoiseach have a truck ready? Does he have a truck with a tail-lift?
He should be on the back of a lorry.
I understand that the Minister for Health went to the Cabinet yesterday to propose the HSE spending plan for 2016. From what we know about his proposals our health services will continue to be underfunded. One of the big ideas the Minister, Deputy Varadkar, proposed was based on the assumption that 125,000 medical cards will not be required next year. I do not know how the Government worked that out but I tried to picture the scene where the Ministers all sat around the Cabinet table, cogitated on this and obviously did not consider that there is a deserving citizen and a family behind every medical card. It was all a numbers game. Maybe one Minister said, "Well, 125,000 fewer medical cards, that sounds a wee bit high". Maybe somebody else said, "Let us go for 100,000 fewer medical cards". What was the Taoiseach’s preference? Was it 80,000 or 75,000 fewer medical cards? Did he pull numbers out of a hat?
It must have been a bingo game.
Did he do a version of “Winning Streak”?
Deputy Adams would know all about doing lotto numbers.
Is that how the Government came up with the figure of 50,000 fewer medical cards? It is little wonder that the head of the HSE recently acknowledged that there is no plan, no money and no vision for the health service. The Government’s stated intention is to maintain existing health service levels. Existing levels mean that, this morning, 331 citizens are lying on trolleys in accident and emergency departments. The Minister’s proposal, which is now the Government’s policy, envisages continued waiting lists, the capping of fair deal schemes, continued trolley waits and more waiting lists for home help hours and less money. Every day as we sit here, facing Christmas, staff and patients face appalling and chaotic conditions in our hospitals and the Government, the Taoiseach and the Minister for Health refuse to address these. The Government has no plan or vision for the health services and it is making life a misery for tens of thousands of patients and their families. Why does the Government persist in making a mockery of our health services, health workers, patients and their families by refusing to deal with the root cause of the crises in the health service?
Deputy Ó Caoláin is a decent man and Deputy Adams has forced on him a health policy that stipulates that it will provide everything and pay for nothing.
That is what the Government does.
That is nonsense. For the record, I am very proudly the Member who sent the Taoiseach these proposals.
Tell us where the money comes from.
The Taoiseach should be on the back of a lorry. The Government is really worried about them.
We can have one brought in.
Sinn Féin has come around to the view that we should have a universal health care system.
That is the universal answer.
No need for the chorus, thank you.
It intends to pay for that by nailing everybody earning over €80,000 with taxes.
Not at all and I look forward to the opportunity to implement it.
There will be less disposable income, fewer jobs and it will drive investment out of the country. That is what Sinn Féin stands for now.
There will be no taxes.
The Government has been very clear about this, as was the Minister for Health this morning in respect of medical cards. There will be no changes to income limits, no change in guidelines and therefore zero cuts in medical card numbers.
Does the Taoiseach believe that?
What we do stand for is the creation of more jobs that pay, fewer taxes on people and the abolition of the hated universal social charge brought in by the Fianna Fáil Government that drove this country onto the rocks.
American taxes and European public services. That is not going to work.
That sounds like an election broadcast.
This plan includes over €800 million extra with €100 million allocated for new initiatives, such as €13 million for acute services; the opening of a newly commissioned and built endoscopy unit in Roscommon; Wexford General Hospital, delivery suite; the acute floor, including emergency departments, in St. Luke’s Hospital in Kilkenny; the acute medical and oncology units in St. James’ Hospital, Dublin; Mercer’s institute for successful ageing-----
The Taoiseach should be on the back of a lorry.
What about Beaumont Hospital?
-----maternity services. We established the national women and infants health programme to lead the maternity strategy-----
What about the game-changing promissory bonds worth €25 billion?
Deputy Mathews should stay quiet.
-----the ongoing development of the national children’s hospital, and €10 million in new technologies in the implementation of the cancer strategy.
What about the €25 billion in promissory bonds?
Would Deputy Mathews stay quiet?
Burn the bondholders.
There is an investment of €7.25 million for investment in further disability services; an additional €2.5 million provided for the primary childhood immunisation programme; an extra €7 million for the ambulance service, which Deputy Adams has raised on many occasions; expansion of respite beds, palliative care; and-----
That does sound like an election broadcast.
-----and €35 million earmarked for mental health services.
The Government should cancel the €25 billion promissory bonds.
The Deputies opposite may laugh about it if they wish.
This sounds like an election broadcast.
It is part of the service plan. The Deputies may laugh about it if they wish.
Is the Taoiseach on the back of a lorry or is he in the Chamber?
He is on a low loader.
Cancel the €25 billion promissory bonds.
There is €35 million invested in health services which is so dear to Deputy Ó Caoláin's heart.
What about the promissory note?
Funding is provided for the continuing general practitioner contracts and developments and for speech and language therapy.
I know we are going on our holidays but the Members should not get too excited. It is tomorrow, not today.
The Ceann Comhairle should send a few of them on an early holiday.
Would they please allow Leaders' Questions to continue properly, with no smart remarks from the sidelines?
Speech and language therapy has been highlighted as needing a specific focus and it is getting that. These are new initiatives in the service plan, which has been approved by Government and which the HSE will publish today. This will maintain services and provide a targeted focus on particular services that I have outlined here, unlike Deputy Adams’ vision of having everything provided but with nobody paying for anything.
Will the Taoiseach expand on the universal health care policy?
That sounds familiar.
The only thing the Taoiseach gave me was his cold. He told us what he stands for: no plan, no vision, no money. He ignored entirely my question about people being taken off medical cards next year. People are sick and tired of his spoofing about all of this because they know the reality of what is happening in our health services. Does he remember in 2007 he pledged to end the scandal of patients on trolleys? In 2011 he promised to end the two-tier system of unequal access to health care. The Taoiseach should remember his five point plan. We can expect more promises from him as the election looms closer. A Fine Gael promise in January will be worth as much as a Fine Gael promise today or yesterday, it will be worthless, just like a Labour Party promise.
We did publish our strategy for health and we sent a copy to the Taoiseach. I commend it to him.
I read it.
It is also on our website because unlike the Government, Sinn Féin does have a vision for universal health care.
How is Sinn Féin going to pay for it?
On this Government’s watch our health service has gone from bad to worse. It is now completely chaotic and the Government’s Christmas gift to citizens who may be ill is 50,000 fewer medical cards next year.
It is a fairy tale.
New York, New York.
A "Fairytale of New York".
That is the year the Government will have the gall to commemorate the 1916 Rising. The Taoiseach should be ashamed of himself.
Our health service is good enough for everybody else.
The Deputy’s strategy for the health service is all rhetoric.
I did read the Sinn Féin health strategy. It is a wonder to behold.
The Government should implement it.
Deputy Adams promises to go around the country and have that decent man beside him, Deputy Ó Caoláin-----
Promising to keep hospitals open. Universal health care.
This is the start of the Fine Gael campaign.
-----stand up in public and say “This is a plan for the nation. We will provide every facility and you do not have to pay for anything.” Just like the boys and ladies on the Fianna Fáil and Independent benches, there will be higher taxes, fewer jobs, less investment and less disposable income.
If the Deputy thinks he can convince anybody of the health care programme he has there, well then fair enough.
It does not work.
He says we have no plan, no vision and no money.
Would you please stop?
This health service plan is costing almost €13 billion, which is €800 million more than last year, and guaranteed to maintain services. I read out a list of focused and targeted initiatives on new services and new investment.
Medical cards, Taoiseach.
As regards medical cards, the Deputy is clearly aware that 1,000 jobs per week have been created following the Action Plan for Jobs and confidence is returning to the economy. That means of course that somebody who has a medical card today and is unemployed, who then gets a job, will retain that medical card for three years.
The incomes of many people in employment will increase and they will be getting back some more in the USC in January. They may find themselves outside the income limit and become GP card holders, the number of whom will rise by 50,000 next year. As the Minister pointed out, with no change in the criteria and no review, 40,000 people moved out of the medical card sector last year. We expect that to be something of the order of 50,000 this year.
The Government's plan is to create more jobs, reduce taxes and therefore-----
No public services.
-----have more people able to invest in these kinds of services.
We are over time.
The latest figures, published on 7 December, show a reduction in the waiting lists across all categories.
Therefore, unlike the Deputy's attack, the reality is actually different. We have not met all the challenges successfully, but the investment is now going in whereby that process can be continued and completed.
Since a court in Northern Ireland ruled that a near total ban on abortion there is in breach of the European Convention on Human Rights concerning women who are pregnant with fatal foetal abnormalities or pregnant as the result of sexual crime - that is, rape - a number of highly courageous women have come forward and publicly told their heart-breaking stories. These involve having to travel to the UK for an abortion, after being told that their much loved and longed for baby had no chance of survival outside the womb.
The Taoiseach's response to this has been to promise a citizens' convention on the eighth amendment, should Fine Gael be re-elected. He has indicated that when a legislative framework comes before the Dáil, he will permit Deputies a free vote on the issue.
Ahead of the upcoming election, public emotion is running high on this issue. Yet it was running equally high when the Whip was exercised on both Deputy Clare Daly's and Deputy Ruth Coppinger's proposals to legislate for abortion. On that occasion, one of the most emotive speeches in the Dáil was given by Deputy Richard Boyd Barrett who has known the effects of fatal foetal abnormality. It is an awful shame that we did not take note of that opinion. If so, we would not have eight to ten women leaving for the UK this week to have an abortion. I will tell a story about that in a few minutes.
There is an umbrella group representing 40 organisations in Ireland and I have spoken to many of its representatives in recent weeks. They include the National Women's Council of Ireland, pro-choice groups, trade unions, and human rights organisations, such as Amnesty International and the Irish Council for Civil Liberties. They are now asking every candidate to state their position on this issue.
I am aware that this issue is a divisive one in the Taoiseach's party, not to mention across the country. However, it is now widely acknowledged that we need to put aside our emotions and adopt an evidence-based approach to this debate. The evidence is that Article 40.3.3o does not stop Irish abortions, it merely exports our problem.
In the interests of accountability, will the Taoiseach instruct each candidate in his party - whom he has said he is confident will be elected to form the next Government - to publicly state their position on repealing the eighth amendment? Would the Taoiseach agree that voters are entitled to know exactly where candidates stand on the issue before casting their vote? Because of the party whip system they have been prevented from doing so in the 31st Dáil.
The outcome of the 2016 election is not known and obviously will not be known until the people have cast their votes. I am not going to be in any way presumptuous about the outcome of that, nor should I be. I have given my view in respect of this-----
You could have had it in November.
Stay quiet, would you?
-----matter, which has been the source of very bitter and divisive debate on many occasions over the past 30 years or more in this country. The eighth amendment is obviously the case in point here. I have always said that I am opposed to abortion on demand. I do understand, in so far as I can, the difficulties that many people have faced because of a variety of circumstances. What I have committed to is that if this party is returned to government, I will set up a citizens' assembly within six months, composed properly of a fair regional and gender spread, to look at the question of the eighth amendment.
A citizens' assembly. You are in one.
That will be followed by analysis by an appropriate Oireachtas committee. If, out of that process, taking into account the comprehensive and sensitive analysis, there is a set of options to be considered that comes to this House, Members of this party will have a free vote on that.
Everybody understands the eighth amendment was put into the Constitution by the people and can only be changed or amended by the people. That does require sensitive, considered, careful and comprehensive discussion. That is what I have committed to and that is what I will stand by.
On 29 November, a 32 year old woman called Anna Marie left Waterford, driving alone to Dublin and then flying to London. There she was picked up by a mini-bus with eight other women in the vehicle. She told me that the eight others were all aged 17 to 19, some of whom were vomiting and weeping. She said that what frightened her most was the silence on that mini-bus as they were taken to the clinic, where nobody spoke, as well as the isolation and the loneliness. By the way, they had to make the same journey all the way back home and she had to drive down to Waterford. The woman is in a terrible state. She was to be here today, but I am not too sure if she is.
I believe the Taoiseach to be a man of compassion and I have never said otherwise. Would he allow this to happen to his own daughter? I do not know if he has a daughter. Would anybody here in the Dáil allow it to happen? Would the Taoiseach like to see his own daughter, in the emptiness and loneliness of a terribly frightening situation, having to leave her own country? I have three daughters and I would not like to see any of them having to go.
Very many young women do not tell their parents or friends - they go on their own. It is not the procedure that does the psychological damage to them. Believe it or not, all the indications are that it is the fact of having to make that journey on their own that does so. None of us should be sitting comfortably knowing that today a mini-bus is leaving Glasgow or London to take nine or ten such women to clinics, some of them as young as 17 or 18.
We are way over the time.
They are without family, friends or partners. Knowing that we have exported this problem over to England, I think it is inhuman. I would ask the Taoiseach to reconsider this position, particularly concerning people with fatal foetal abnormalities, or women who have been violently sexually assaulted and raped. This is an issue of compassion. We cannot continue to be inhuman in dealing with our citizens and exporting the problem.
I read the story that Deputy Halligan has referred to. It is one of many where these circumstances cause great stress and difficulty for so many people. That is why I believe we should have a respectful, rational and sensitive discussion involving the people, about their views and the options that they would consider as to what might be done.
I also recall watching a television programme recently about a woman who was given two opinions that the child she was to give birth to would not survive with a fatal foetal abnormality, which was not the case. These matters are all part of life.
I have committed to what I think we can do in a respectful and rational way about this. At the end of that process, a decision comes to this Chamber which will be a matter for the make-up of the next Government. Members of the party I lead will have the right to have a free vote in respect of their view on it. I thank the Deputy for raising it in the way he did. I feel we need to look at this in 2016 in a rational, respectful, sincere and sensitive way, and that is what I commit to.