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.

Stay quiet.

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.