Cystic fibrosis, CF, is a very debilitating condition. Ireland has the largest cohort per capita of population of people with CF. Consistent research has helped improve the quality of life and extend the lives of people with CF. Given that we have the largest cohort per capita of population of people with CF, there is an onus on this country to be in the vanguard in terms of research and new technology in respect of extending life and improving the quality of life of people with CF. Orkambi is the first drug to impact on the underlying cause of CF for up to 50% of people with the condition in Ireland. It has been shown to produce both a reduction in the worsening of CF requiring hospital admissions and a sustained increase in lung function and weight, which is an important issue in the context of CF care. Orkambi has been approved by the Food and Drug Administration in the US and could apply to approximately 50% of people with CF in Ireland.

A wonderful article written by Orla Tinsley, a CF patient, that appeared in The Irish Times on 2 June 2016 details the new life Orkambi has meant for her and those with compassionate access to the drug via the relevant pharmaceutical company. It is worth reading the article to get a sense from somebody who has lived with this condition all her life and who has fought all her life to try to improve quality of life for people with CF. Orkambi has transformed her existence. Ms Tinsley gave an interview on "Today with Sean O'Rourke" some time back to talk about the impact of the drug on her. People such as Jillian McNulty have testified to the positive impact a drug such as Orkambi can have on CF sufferers. Orla Tinsley made the point in respect of one of her friends who has compassionate access to the drug that "Removal of Orkambi is a catapult towards death for her."

This is what it is like in the CF community for those who are taking Orkambi. Others have been waiting for approximately two years since the drug was first approved to gain access to it.

It is not just a Government issue. It is also an issue for the pharmaceutical companies. The pharmacoeconomic unit rejected it in the context of the cost submitted by the company. Negotiations between Government agencies and the company have been going on for a considerable length of time. Is the Government still committed to giving CF patients access to Orkambi? As I have asked before, is it not time for the Government to establish a separate fund from the health budget in which we could continuously invest to provide for new technologies and drugs such as this so we can be at the vanguard of new developments in medications and drug therapies?

The Deputy's point is best addressed by people who have CF and have to contend with it. The situation has improved for a great number of CF sufferers compared to years ago. After many years of tribulation, there have been formal openings of a number of CF units around the country. From talking to patients who have the use of them, I know provisions such as the recirculation of clean air mean so much to their lives. As the Deputy pointed out, it used to be that the Government would accept or reject the prices put forward by pharmaceutical companies. Now, the decision is based on a clinical assessment of the effective outcome of treating a patient with a particular drug. This is based on the assessment of the improved quality of life for the patient, depending on the nature of the treatment they receive. This also applies to other drugs for other ailments. The Government, the Department of Health, the Minister and the HSE are committed to continually improving the situation for CF sufferers and this is evident in the programme for Government. The evidence is there before our eyes in better facilities.

A process is taking place arising from the clinical assessment of the improved quality of life for CF sufferers who take Orkambi. This means meetings between the HSE, the pharmaceutical company and the clinicians involved. I hope an outcome can be arrived at, as has happened in a number of other cases in which the original price set by pharmaceutical companies was reduced to a level where the clinical assessment was that it was worth the cost in terms of the improved quality of life it could give. These are clinical assessments, as the Deputy is aware. I will have the Minister for Health give me an update on the progress on those meetings on appeal to see if Orkambi can be made available at a price that would justify a clinical assessment of it improving the quality of life for people. It is a very sensitive and important question.

It is a life and death issue and it is a fundamental imperative that we do everything we possibly can to improve the quality of life and extend the life of those with CF. There is no doubting the health benefits to be derived from Orkambi. In the assessment it was rejected "at submitted cost"; in other words, it was regarded as too expensive. The benefits are well reported not just by those in the clinical trial, but objectively.

There is a cost issue and our policy across this area is somewhat flawed. Regardless of whether we like it, the costs keep interrupting our process. There was a cost element with other drugs that have recently been approved. Until recently, new drugs and therapies had to be approved by the Department of Public Expenditure and Reform.

In the final paragraph of her article in The Irish Times Orla Tinsley wrote:

I am so far away from the constant daily struggle I was once confined by that this thought is newly harrowing. [She is in a better space, having had access to the drug in the United States.] Generations need not suffer because a drug company and a government cannot negotiate a real solution. There must be a price reduction. The results of the Orkambi trial were released two years ago this month. [This was last June.] That's two years the 505 Irish people suitable for Orkambi have been waiting to sail on to that new chapter of their lives.

I respectfully suggest that the process has dragged on for far too long. There needs to be a resolution, an impetus and an injection of urgency in order to get this sorted.

I thank the Deputy. Obviously, the situation here, as I said, is not a political decision any more. I recall the interview given on the national news by the specialist involved. On 1 June, the National Centre for Pharmacoeconomics, NCP, recommended that Orkambi for treating cystic fibrosis should not be reimbursed by the HSE. As to the prices submitted by the pharmaceutical company, the cost was €160,000 per patient per year. The NCP indicated that the price would have to be below €30,000 per patient per year to be cost-effective. That is a clinical assessment, not a political one. As Professor Michael Barry stated in his recent expert opinion on the evidence submitted by the manufacturer, the latter got it wrong when it came to pricing. Deputy Martin and I know that the level of cost submitted by some pharmaceutical companies is quite astronomical in the case of certain drugs. Drugs require a clinical assessment as to whether their use is justified.

The NCP estimates that the five-year gross budget impact of Orkambi is more than €390 million and notes the significant opportunity cost of reimbursing the drug as being two thirds of the cost of the children's hospital for one drug alone. If the clinical professor says that the pharmaceutical company got it wrong, is it not important that we should follow through with meetings with those representatives to see can that be reduced? It is not the end of the process and I hope that the HSE will continue to work on price negotiations on Orkambi.

The Deputy made one other point about having a ring-fenced structure for dealing with new drugs that come on the market, which they do every year. That is something that I would be prepared to look at in conjunction with the other parties.

It is essential.