Joan Collins (Dublin South Central, Independent)
Link to this: Individually | In context | Oireachtas source

I tabled a written question on 24 January asking what the status of talks were between Vertex and the HSE. The reply stated that talks resumed last December and the Minister stated at the end of February that a decision would be made in a matter of weeks. It has now been months. It has been a very frustrating ten months for people in respect of this issue. On 28 and 29 March I received calls from parents of CF children saying Vertex had contacted them to say no contact had been made with it since 2 February. I submitted this Topical Issue matter on 30 March and unfortunately the Minister has not been available since then. Maybe he was waiting for today.

Cystic fibrosis awareness week starts this week. I watched Jillian McNulty last night on the "Claire Byrne Live" show, as well as Ronan and Linda, the parents of young Finn, and Aidan, who are waiting for Orkambi. I believe the talks started again last week. The price has gone down but it looks like the HSE is looking for a package for future drugs like VX-661, which is really a game changer for people with CF. Members of the CF community feel they have been pawns in this process, between Vertex putting them under huge anxiety and the Minister suggesting earlier this year that there would be announcements imminently. Vertex was looking after its own self-interest there, as well.

I would particularly like to mention Hazel Robinson, a mother who has been camping outside these Houses for the last days. She has a young daughter who has CF. I got word that there could be a statement in the Dáil today and I presume that is why the Minister, Deputy Harris, is in the Chamber. I hope the statement is a positive one. If it is not people will be very angry tomorrow at the demonstration at 1 o'clock. I hope they will be out there celebrating rather than being angry.

Gino Kenny (Dublin Mid West, People Before Profit Alliance)
Link to this: Individually | In context | Oireachtas source

I think the Minister might have good news. I was looking at his Twitter account. We will see in a few minutes. Hopefully it is good news for the many people who have been waiting for an end to this long drawn-out saga. Hopefully weeks will turn to minutes now. As Deputy Collins said, there is a young mother, Hazel Robinson, outside the Dáil at this moment. She has been sleeping there for the last three days. She is campaigning for her own daughter, Gypsy Anne.

This makes us reflect on why people go to such desperate measures to highlight such desperate situations. It is terrible that people have to resort to such things.

I hope the Minister will have some good news today in this regard. I realise talks are ongoing with Vertex Pharmaceuticals and the HSE over a proper price structure for Orkambi. I hope the Minister can give a commitment today to the effect that the people who could benefit greatly from this drug can get good news. That would enable them to get on with their lives. If we could start to administrate that, it could help a great many people. It is down to the Minister.

Simon Harris (Wicklow, Fine Gael)
Link to this: Individually | In context | Oireachtas source

I thank Deputy Collins and Deputy Kenny for raising this issue in the Dáil. I thank Deputies from all sides of the House who have consistently over a long period raised this important issue relating to cystic fibrosis patients. In raising this issue this evening, the Deputies have provided me with an important opportunity to provide an update in the Dáil on behalf of myself, the Minister of State at the Department of Health, Deputy Catherine Byrne, the Minister of State at the Department of Health, Deputy Finian McGrath as well as all of us in government.

I am pleased to inform the House and in particular cystic fibrosis patients, their families and friends, that the HSE and Vertex have this evening confirmed that an agreement has been reached in principle on the commercial terms for the supply to Irish patients of Orkambi and Kalydeco from next month, and for other treatments and age cohorts following market authorisation in Europe. I am keen to provide this update this evening to the House to offer reassurance to patients on this important matter and to inform them that the HSE and Vertex expect these medicines to be available from next month. I also wish to inform the Dáil that both parties are now working to finalise the contractual arrangements and complete approval processes in advance of 1 May.

I recognise the work the HSE has put into these negotiations over a long period. These were not easy negotiations. A large body of work needed to be done on this important matter. I want especially to acknowledge that this has been an extraordinarily difficult time for cystic fibrosis patients, their families and friends as they have been waiting for this process to conclude. I was determined that the process would conclude and that we would get the best possible arrangement for cystic fibrosis patients. In the past, this group of patients have not been properly and adequately catered for in terms of certainty of medicine supply.

However, I am sure that the Deputies will accept that, given the scale of the investment, the potential benefits for Irish patients and the impact of this decision on the health service overall, it is appropriate to allow the statutory process in this State to be concluded appropriately to bring certainty to matters. As Deputies are aware, the HSE has statutory responsibility for decisions on pricing and reimbursement of medicines in the community drug schemes in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013. In reaching a reimbursement decision, the HSE must examine all the evidence that may be relevant in its view, and it has done so. The HSE takes into account such expert opinions and recommendations that have been sought at its sole discretion, for example, from the National Centre for Pharmacoeconornics.

I will outline the position on Orkambi for the treatment of cystic fibrosis patients aged 12 and older. Following an application by the company, the treatment was assessed in line with the statutory process, following which the HSE called on Vertex to re-enter negotiations. Further meetings were held with the manufacturer in December and early January. The discussions with the company broadened to include Kalydeco and further treatments for CF patients. I hope more iterations of drugs will come on stream and more iterations of drugs will be able to cater for other patients of other ages. It is important we get all these elements right in order that we not only have an arrangement for now but an arrangement that is future-proofed to meet the needs of all cystic fibrosis patients throughout the age spectrum.

Following detailed consideration by the HSE directorate, its legal representative and officials in my Department, further negotiations took place last week. Those discussions have continued up to this afternoon. I am pleased that we are now in a position to reassure people that we are in the concluding stages of the agreement, as I outlined earlier. Further work in the coming days will bring this matter to finality. These drugs will be available for Irish patients in this country from next month.

Joan Collins (Dublin South Central, Independent)
Link to this: Individually | In context | Oireachtas source

That is great news for the CF community, parents, Cystic Fibrosis Ireland and the children. I watched Aidan last night. He is 43 years of age and his lung capacity is down to 40%. For him, that will amount to a life-saving statement. He will be delighted. I sincerely congratulate the community for staying strong although they have been under extraordinary anguish and anxiety in recent times.

I hope that the march tomorrow will be one of celebration and that they will be out in the streets. Those affected expect the talks to be concluded in the coming days in order that they can see the drugs on the market on 1 May. This is especially important for people who have been on the drug on compassionate grounds and other grounds. This copperfastens for them that they will hold on to these drugs in future. That is important.

The Minister referred to future drugs that could be introduced by Vertex. Have they been included in the deal or are they separate issue? I thank the Minister for coming to the Dáil and making the statement today.

Gino Kenny (Dublin Mid West, People Before Profit Alliance)
Link to this: Individually | In context | Oireachtas source

It is good news. There are not many occasions when we hear such news. Sometimes in this House there is good news but most of the time it is bad news. It is good news for the people who are listening, especially the CF sufferers. This lengthy saga has been dragged out.

If there is one lesson that everyone should learn, especially the Government and the HSE, it is that this should never happen again. This has been a drawn-out painful process for those who need essential drugs. It must not happen again. At the crux was the question of drug companies holding governments to hostage. Ultimately, it was about price. We cannot put a price on a person's life or health. That goes across the board. I hope the lesson is learned. Can the Minister comment on the price structure of Orkambi? A figure of €159,000 per year is completely unsustainable. I hope the price can be reconfigured.

Simon Harris (Wicklow, Fine Gael)
Link to this: Individually | In context | Oireachtas source

I thank Deputy Collins, who I know has a sincere interest in this and who has raised this issue on several occasions. I thank Deputy Kenny for his comments as well. It is, as Deputy Kenny, said, a rare enough occasion in this House when we can be unified in our desire to do good and to try to agree on what that looks like in terms of doing good. Providing certainty in terms of access to innovative medicine for patients with cystic fibrosis in this country is a good act.

I have many thoughts on the process in terms of how we negotiate drugs and international collaboration on drug companies. However, I do not believe today is the day for that. I would very much welcome a debate in the House on how we can improve the process and how we ensure we get the best outcome for our patients in the knowledge, ultimately, that the health services in this country and every other country, no matter how large the budget, have finite amounts of money. We should have that discussion and discuss how to keep patients up to date. We should discuss the lessons that can be learned from this process. That would be a worthwhile debate to have in the House and I would welcome it.

I will come back to Deputy Collins on her specific question. I am keen to get clarity on the point first. I do not intend to comment on any specific contractual issues because lawyers need to get involved on both sides. Contracts need to be exchanged and logistics need to be looked at. Ultimately, I need to bring this to Government for agreement at the next available opportunity after Easter. However, I did not want to have this news and allow us go to the Easter recess without sharing the information with patients and their families. I join the Deputies in thanking Cystic Fibrosis Ireland for its advocacy. I thank people like Jillian McNulty and Orla Tinsley. I thank the mothers, fathers, brothers, sisters, friends and people who have contacted all of us. They were all unified by the same desire. They did not want to get caught up in a big political debate. They simply wanted what was best for their loved ones.

Now, we will get on with the process of finalising the arrangements of dealing with the important contractual elements. The message going out to Irish patients from Vertex and the HSE is that these medicines will be available to patients from next month.

Seán Ó Fearghaíl (Kildare South, Ceann Comhairle)
Link to this: Individually | In context | Oireachtas source

I think it would be appropriate to congratulate you, Minister, and all the Deputies who have consistently raised this matter as well as all the valiant campaigners who have been alluded to outside the House on a job well done.