Leaders' Questions

The Taoiseach knows that cystic fibrosis is a very serious issue in Ireland. We have the largest cohort of people per capita who suffer from cystic fibrosis, and all the challenges that presents. We have had some great testimonies from people with cystic fibrosis in terms of how it affects their lives and, in particular, the impact of the latest and very effective medicine, Orkambi, which can have a transformative effect.

I ask the Taoiseach to read an article in the Irish Independent today by Jillian McNulty, who lives with cystic fibrosis. It is heart-rending, brilliantly written and conveys better than anybody else the impact of the illness and the transformative effect of Orkambi. She writes:

CF is a lonely, traumatising, unforgiving, frightening illness yet there's one thing that has made a difference to my life... Orkambi... Before Orkambi I was approximately eight months of the year in hospital, in the last three years I've spent just 12 weeks in hospital. Incredible.

There was an attempt to denigrate the drug, which we saw in leaks from the HSE and others. We now know that Orkambi has received the drug discovery of the year award from the British Pharmacological Society and the French Prix Galien award in 2016 for the most promising rare disease medicine.

The manufacturers of rare disease medicines and orphan drugs, as we call them, are challenging for countries all over the world and we need to change how we deal with cystic fibrosis in this country, something for which I have asked on previous occasions. The bottom line is that the drug has a significant impact on quality of life, the longevity of people living with cystic fibrosis, hospital admissions, lung function and so forth.

There is no doubt about the effectiveness of the drug. Agreement has been reached in Germany, Austria and the United States so that people with cystic fibrosis in those countries can avail of the medicine.

There has been engagement with the company for more than a year and this was ramped up in the past month or so. My understanding is that this has gone through the drugs committee and to the HSE directorate and that the new offer from Vertex to the HSE is far more significant, perhaps, but different from the previous offers in terms of reduced pricing and, more critically, covering future pipeline medications that would cover the cohort of people with cystic fibrosis who have the F508del mutation. In other words, future and better medications will be part of the deal, there is a long-term dimension to it and it covers Kalydeco as well.

I have a basic question for the Taoiseach. People have been patient and Cystic Fibrosis Ireland and its chief executive officer have been very reasonable. Will the Taoiseach let the House know when we can expect a decision on facilitating the availability of Orkambi to people in this country with CF who would benefit from it?

The article is well written. It is one of a series of articles written in recent years about the impact of drugs on the quality of life of cystic fibrosis sufferers. The Minister for Health, Deputy Simon Harris, met personnel dealing with cystic fibrosis during the week. Deputy Martin is accurate when he states that Orkambi is a drug that impacts on the quality of life of a patient with cystic fibrosis, but it is not the Minister who determines the value of that quality of life or how it is measured. In this case, it was done by Professor Barry, who has commented on this issue in the past. The Minister for Health has had to shift the emphasis to major pharmaceutical companies so that there is an understanding that there is a limit to how far one can go in getting the balance between having that quality of life for cystic fibrosis sufferers and having the taxpayer pay the exorbitant amounts of money being demanded in respect of the drug.

It is true that Vertex has made an offer. However, the Minister is trying to bring about a situation where we are not going from year to year uncertain about what the future holds for any category of patients. In this case, it is cystic fibrosis sufferers. That is why the Minister wants to do a deal with the companies in respect of Orkambi, Kalydeco and any other future drug that may be beneficial to the quality of life of cystic fibrosis sufferers. He is right in that regard because we do not want a situation where Orkambi, for instance, is being made available to patients at a certain price based on the improvement in their quality of life and find that the situation changes six months or 12 months down the line.

The Minister is putting together a future certainty for cystic fibrosis sufferers to deal with a pipeline of drugs, be those drugs Orkambi, Kalydeco or new drugs that come on the scene, which happens every year. I expect that the Minister will be able to conclude his deliberations inside a couple of weeks and bring about certainty for all the cystic fibrosis patients in the country of whom we have many of them, and more than most other countries. This will give a certainty to those cystic fibrosis sufferers, whether it is in terms of Orkambi, Kalydeco or new pipeline drugs that may come on the market to treat cystic fibrosis. It is a good thing to do and the right way to go and I hope that, when it is reached, the decision will provide certainty for those with cystic fibrosis in the country.

That essentially has already been done. A long-term deal has been proposed and has gone through the drugs committee but no one has heard anything from the HSE or any other authorised State personnel on this issue since 3 February. Vertex has not received any response to the deal, as outlined by the Taoiseach, that it put on the table.

The offer is a long-term deal - I understand for ten years - covering Kalydeco and Orkambi and pipeline drugs that may be better than Orkambi. My point all along has been that, given the large number of people in Ireland with cystic fibrosis, we should be at the vanguard of this research and leading the charge on this issue. A month has passed since the offer was made. The Taoiseach described it in terms of what the Minister is seeking but it is what is being offered. Has the HSE directorate made a recommendation to the Government following the offer made more than a month ago? People have been waiting for too long and it is placing an intolerable strain on those who are living with cystic fibrosis and their families. The Taoiseach and every Member of the House knows that and there is an obligation to bring this matter to a conclusion.

Deputy Micheál Martin obviously has a great deal of detail on this issue.

Deputy Billy Kelleher tabled a good parliamentary question on it.

What the Minister wants to do is future proof the quality of life for patients who in this case have cystic fibrosis. That is the right path to follow. No other category of patients has ever been future proofed in this way. What needs to be dealt with now is the finalisation of the contractual and commercial details of the arrangements for Kalydeco, Orkambi and whatever other pipeline drugs come on the scene for cystic fibrosis sufferers. The Minister expects to conclude this process in a matter of weeks. It will not be concluded today or tomorrow. In respect of cystic fibrosis patients, the article today expresses very clearly the impact on their lives of both Kalydeco and Orkambi. It is very important that we have a pipeline for the future that will guarantee that those who suffer from cystic fibrosis have whatever degree of certainty we can give them for the future in respect of their treatment and, as a consequence, for the improvement in the quality of their lives. For this reason, the Minister is working very hard to finalise the commercial and contractual details for the future of cystic fibrosis patients.

Visit of Delegation from the United Arab Emirates

Before proceeding with business, on behalf of the Members of Dáil Éireann, I offer a most sincere welcome to Her Excellency Dr. Amal Abdullah Al Qubaisi, Speaker of the Federal National Council of the United Arab Emirates, who is accompanied by six distinguished members of the Federal National Council and joins us in the Distinguished Visitors Gallery. We wish them well in their visit to our country.