On 19 October last, I raised the need to give access to the Orkambi drug to cystic fibrosis, CF, patients. I pointed out that we have the highest number of people per head of population with cystic fibrosis. We should be in the vanguard in terms of research and new drug technologies. Since I last raised this matter, I met Jillian McNulty who has CF and who has been on Orkambi for three years and three months. It is worthwhile to meet her and hear first hand of the dramatic and transformative impact Orkambi has had on her life. One can look at all the statistics and so forth, but one should also meet a person concerned. There is one stunning statistic. In the past two and a half years, Jillian has been in hospital for only ten weeks and that was due to the swine influenza. Before she went on Orkambi, she was in hospital for eight to nine months every year. That is her testimony to me. She has met one of the lead researchers in Washington. This drug has been 20 years in the pipeline and billions have been spent on bringing it to fruition.

There has been an attempt in recent times to talk down the effectiveness of the drug. That is wrong. The leak last week to The Sunday Business Post has been described by Cystic Fibrosis Ireland as a heartless and disgraceful form of communication by the Health Service Executive, HSE, to people with CF. It was disgraceful and heartless but it is also part of an agenda that appears to be about talking down the effectiveness of the drug. If it was so ineffective, why would the HSE spend 25 to 26 weeks negotiating with the company? I do not deny that there are issues with the cost. However, let us accept that this drug has an impact and is effective in terms of lung function, weight gain, quality of life and independence. Jillian McNulty said that to me but there is no need to take my word or her word on the matter. Cystic Fibrosis Ireland, in its open letter to the Minister, makes that point and it is very disappointed by the degree to which the acknowledged international research is in many ways being dismissed by the HSE and others. It also references Professor Stuart Elborn of Royal Brompton Hospital, a leading facility for the treatment of CF, in this regard. The research to which I refer points to the extraordinary impact the drug is having and how exciting it is, not just in the short term but also for its long-term impact on the condition.

Will the Government intervene to ensure that this drug is made available? Will it also ensure that there will be no more talking down the effectiveness of the drug for people with CF?

I thank the Deputy for raising this question. It is an issue of considerable concern, particularly for sufferers. The Minister for Health, Deputy Harris, has made it clear that he wishes to make progress on this issue.

There is no attempt by the Government to talk down the benefits of this. Indeed, other Ministers have met families directly affected and are very aware of the concerns. However, approval of a drug of this nature has been taken out of the political process, as the Deputy knows. We have decided, as an Oireachtas, that this would be decided based on the medical evidence and we have appointed those who are experts on this. As the Deputy rightly said in his comments, both the effectiveness and the cost must be considered. The National Centre for Pharmoeconomics, NCPE, which has expertise in this area, has been clear that it views that this company is not approaching this in the proper way and is not showing sufficient concern for patients' needs in the approach it is taking to the pricing of this particular product. There have been intense discussions between the Health Service Executive and the company to seek to get agreement.

It is should be noted that none of the other Governments that have sought to find agreement have been able to reach one. Canada, Australia and other countries have not been able to reach agreement with this company and the Minister for Health has taken the step of aligning himself with those other countries in order that we can form a group together to get a proper and decent outcome for patients suffering from this condition, some of whom can significantly benefit from this product, of that there is no doubt. The Minister, Deputy Harris, is acutely aware of the position and is not only continuing to press the work that is done here but is seeking to get co-operation from across other Governments and Ministers for health who are in a similar position seeking to get a good outcome for their patients. The product has to be brought within an affordable level. The NCPE has to be in a position to show that this treatment will be effective at the price at which the drug is being provided. That work is being pursued very intensively. The Minister has taken the unusual step of seeking to get a coalition of other Governments to approach this company in a concerted way in order that we can get assurance that this product, which has hugely beneficial effects for some sufferers of cystic fibrosis, can be made available. I assure the Deputy that everything will be done but it will be done within the legal provision that we have all agreed in this House.

I do not accept the Minister's response in its entirety. Up to very recently the Department of Public Expenditure and Reform demanded the right to sanction any new drugs and the Minister for Health had to go before the Cabinet. That was the position. I know that to be the case up to very recently, even up to the time the new cancer drug pembrolizumab came along. Professor Stuart Elborn has said:

Long-term follow-up data has indicated that this treatment can prevent disease progression.

Initially, we were able to show that you can make people a bit better. Now we're seeing exciting and reassuring long-term improvement.

We hope it will lead to a further rethink about the long-term benefits.

I am really excited ... [about] the therapy and also the pipeline of other powerful drugs that could get us closer to a cure.

We have the highest number of cystic fibrosis patients per capita in the world. We should be leading this in terms of new technologies and clinical trials and engaging with the industry, not in a reactive mode. Jillian McNulty has said to me that she is convinced that she would not be here without this drug. That is her assessment of the situation. I take that seriously. There is a lot of medical evidence that has not come to the fore and there has been an attempt to talk it down. I believe the context of the discussions would change if there was an acceptance that this drug was effective and was an impactful therapy for people with cystic fibrosis. I am glad the Minister has at least confirmed that much today.

The Deputy's time is up.

We should be under no illusion that the leak last Sunday was to send a message that this was not going to happen. That is what the leak to The Sunday Business Post was about.

That is not true.

The decision was taken. That is why it was leaked. We need to reverse that and get to the front line-----

Thank you, Deputy.

-----and be in the vanguard of new technologies. I apologise, a Cheann Comhairle, and I thank you.

I can assure the Deputy that the Minister is absolutely at the front line-----

Yes.

-----but the difficulty has been that the technology assessment has shown that at the price being demanded for the drug, it is not medically cost effective. That has been found to be the case not only in Ireland but in Australia, Canada, England and Scotland. All those countries are having difficulty with this company in getting a reasonable pricing of the product. That has been confirmed by the technical work done here.

The Minister is, therefore, taking the lead as, quite rightly, the Deputy has asked him to do. He is seeking to build a coalition between those bodies in order that countries can work together to try to reach a sensible outcome. The countries in question have not been able to approve it under their reimbursement codes either in light of the high price being charged. They all recognise its benefits but they have not been able to approve it. That is what we need to get from this company.