John Brassil (Kerry, Fianna Fail)
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I will cut straight to the chase. This is the second time I have raised this as a topical issue. The last time was in March and the battle has continued. In September the drug Respreeza was made available by its company for six months but the administration and distribution were not agreed. There were 21 patients but there are now only 19 as two have tragically passed away. I say this with a heavy heart but I feel the Oireachtas, the HSE and the Minister have failed this patient cohort. There has been intensive lobbying and I acknowledge that the Minister took calls and had meetings with me on this matter. On Saturday night the HSE agreed to fund the administration of the drug for the next six months but it stated that it had agreed to a six-month transition in the interests of patient safety to allow patients to transition to alternative care arrangements. If there were alternative care arrangements for these patients they would have been on them a long time ago.

This drug has been life-changing for the 21 patients to whom I referred. It defies all logic for people to continue to make the argument that it does not work. Two patients have passed away in five weeks without this drug and another patient is seriously ill in hospital as we speak. I hope his recovery will be promoted by the reintroduction of the drug. A fourth patient in Kerry is showing serious signs of deterioration of health and a fifth, who had not received an antibiotic for three years, is now back on antibiotics. I cannot be convinced that this drug does not work - it does work.

If the Minister does not want to fund it, he should state that he does not want to because he does not have the money. I ask him to stop making the argument that the drug does not work. It most certainly does.

Alan Kelly (Tipperary, Labour)
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The Minister is aware of my views on this issue. I have spoken with him and raised it numerous different ways with the HSE and with his office. I spoke about orphan drugs at a committee. Last Friday was, for personal reasons, probably one of the angriest days of my life in politics. I was quite upset. A neighbour of mine, Marion Kelly, passed away. She was one of the two people who Deputy Brassil spoke about. Marion had been in my office numerous times. I knew her. She was an absolute lady. My point is that she was not given the best chance. We are not necessarily saying that if they were on this drug continuously, Marion or possibly the other lady up in Donegal would not have passed away, but that the body politic and the health system are letting these people down. These two people have been let down.

Marion is a neighbour of mine, originally from Puckaun, who lived in Nenagh. She was an absolute lady, loved by her locality. The people of the locality feel that she did not get the best chance to continue, leaving her daughter, her grandchildren and her family behind. She died quite suddenly. No one can tell me that it is fair for somebody to be on Respreeza for 11 years and then, through the politics of health - it is political, whatever side one is on, whether the Department of Health, the HSE or the drug company - for the hope that these 21 people have been given, with 60 more people in total affected by alpha-1 antitrypsin deficiency, to then be taken away. Suddenly, after Marion passed away, the HSE issued a statement at the weekend that it will administer the drug for a period of time. There is no alternative. Marion used to be in hospital seven or eight times a year. That went down to once or twice a year. The health benefits are obvious. We are talking about €84,000 a year. She put up a petition on Facebook, fighting for her life, asking people to support her. I supported her as much as I could.

The ultimate issue here is that the health system and health politics let her down. Her legacy needs to mean something. I know that from her family. We need to intervene for all other alpha-1 antitrypsin deficiency patients and those others coming down the line. These costs are not exorbitant. I do not want a situation where this will continue. We cannot say that there is causation and that these two ladies passed away because of the five or six weeks they were off the drugs. The facts are that they were able to survive for 11 years using this drug and that both passed away in a very short window of time. Please bear that in mind.

Simon Harris (Wicklow, Fine Gael)
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I thank Deputies Brassil and Kelly for raising this issue, not just on the floor of the Dáil but on many occasions over the last number of weeks and months and for keeping in close contact with me directly on the matter. Like both Deputies, I express my deepest sympathies to the families of the patients who have recently passed away and offer my condolences and, I am sure, all our condolences at this difficult time. I cannot begin to imagine what those families must be going through.

As the House will be aware, a number of patients had been on a Respreeza access scheme operated by the manufacturer for a number of years until that company decided abruptly earlier this year to end the scheme for all patients on 30 September 2017. This access scheme was not one which had been established with the HSE's involvement. It had been directly established by the company. Nonetheless, I asked the HSE to satisfy itself that arrangements were put in place for the continued appropriate care of the patients concerned. I asked the HSE for the appropriate care because I am not a clinician and it is the responsibility of the health service to ensure there is appropriate care, and the HSE then engaged with the company over a number of weeks. I understand that the company agreed to continue to supply the medication free of charge for the patients who had been on the access scheme for a further period of six months, or until a further clinical trial commences next year. However, the company was not willing to continue to cover the cost of administering the medicine to these patients. The HSE, having considered all the circumstances, has decided to facilitate a transition arrangement under which it will fund the provision of the necessary nursing service to ensure that the treatment of patients can resume. I have often been critical of the HSE but I will say on the record of this House that I have seen the HSE work extraordinarily hard to try to come up with innovative solutions. It has sought meetings with the company to engage with it over a sustained period. The Health Service Executive did Trojan work to try to put in place an arrangement to get this drug flowing to patients again. I deeply regret the circumstances that happened in the intervening period.

The new transition arrangements will facilitate the immediate resumption of the administration of the drug to the affected patients and will continue until a further clinical trial commences in 2018. The company anticipates that approximately half of the current compassionate access group of patients will be recruited into the next clinical trial in 2018. The terms under which the HSE has agreed to fund the administration of the drug include a requirement that the lead clinician concerned ensures that appropriate alternative treatment regimes are put in place in good time for those patients not proceeding to the next trial. The HSE has agreed to fund the nursing service to administer the drug during the next six months because the company firmly refused to fund further administration of the drug in the period to mid-2018 when the next trial is due to begin. However, factually and legally, that decision does not in any way alter the position regarding the HSE's formal decision not to reimburse Respreeza.

I assure Deputy Brassil that the Health (Pricing and Supply of Medical Goods) Act 2013 gives the HSE the power to decide whether or not to fund a drug and its drugs group comprises ten clinicians. This is looked at from a wide range of areas. The HSE has previously considered the pricing and reimbursement of Respreeza through its decision-making process. I would say to the company and the HSE that they should not squander these six months and should continue to engage further. It is open to the company to produce more evidence, more information and to negotiate further. That is what should happen. We should not have a company that has total ownership of the access scheme with no HSE involvement ending the scheme in an abrupt manner, leaving Irish patients high and dry. I do not want to engage in the blame game against the company or the HSE, since the matter is too important, but the company has obligations as well as the HSE. I am pleased that arrangements have been made to resume treatment for patients which will allow a safe period of time but my appeal today is not to waste that time and to ensure there is further engagement with the company and HSE, and I will work with colleagues on this.

John Brassil (Kerry, Fianna Fail)
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I agree the six month period cannot be wasted but there is a potential for another trial and for half the patients to be facilitated. That means that half will not be facilitated. Can the Minister imagine the mindset of the ten or so patients who may not get on to a trial, having seen what happened to their two colleagues, Anna and Marion, in the last few weeks, and the sort of effect that has on their well-being? The company has not performed with glory here, nor has the HSE, nor have any of us but the fact is that it is our job to look after the citizens of this country. In whatever objective analysis one looks at, patients were on a drug, being maintained, having a quality of life and two people passed away within five weeks of the drug not being administered, with another hospitalised, another extremely unwell and another back on antibiotics. That sort of evidence speaks for itself. I want to get away from who is right and who is wrong. Whether we like it or not, the HSE has, in the interests of patient safety and well-being, agreed to administer this drug. It is in the system now and it is up to us to solve it so we do not come back here in six months with the same pleadings, the same Topical Issue matter and the same health issues that these patients could run into. We should have a solution in that six month period. I plead with the Minister to set himself a deadline for the HSE and company to have this resolved before the six month period has elapsed.

Alan Kelly (Tipperary, Labour)
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I accept everything the Minister said but, to be honest with him, the families and those involved do not and cannot accept it. It is nothing personal, but they cannot. They do not care about this inter-wrangling or the politics involved. I agree with the Minister about the drug company's behaviour. I assume the HSE is doing its best. I accept all of that. However, these people do not care. These 21 people know one another. Two of them have passed away during this little window of time. It is quite obvious that others are affected. I knew this lady and I know her family. They want this to stop. They want her passing to be in some way a spark that will ensure the rest of the people are kept on the drug, that it is administered and that the process by which this drug can be approved happens. I know the process, which we have gone through in committee, the NCPE, the HSE's decision-making process, the toing and froing and all of that, but we all also know that other drugs have been approved.

This is a modest amount of money for a small group of people who deserve better. They do not care about whether it is the drug company, the HSE, the Department or anyone in this Chamber who achieves it because all they want is a solution so that they can plan their lives in some form of quality way. Please help them do it.

Simon Harris (Wicklow, Fine Gael)
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I agree with both Deputies that the patients deserve better. I do not think anyone could disagree. It is important to note, first, that everyone is back on the drug in the sense that the drug is being supplied. I reiterate my absolute sympathy to the families of the two people who have passed away. This trial was and is a clinical trial by the company and while it is this drug today it will be another drug next week. It is this group of patients today but it will be another group of patients next week. There are rule books and there are ethical ways for a company to engage. For a company to set up a clinical trial completely independent of the health service in any country and then abruptly end it, saying that is it for those patients, is not the way to treat patients who help develop its drug and product which ultimately makes it a profit. That is not just my view. There is also the Helsinki declaration. There has to be rules of engagement in terms of how a company behaves ethically in this country. I appreciate that both Deputies agree with that. I also appreciate that it does not help the patient sitting at home today, wondering if he or she will be on the drug in six months time.

As far as I can tell, it is unprecedented for the HSE to take this step and fund the nurse administration. They are doing so, recognising the seriousness of the situation. I reiterate that there is now a period of time available and that I would like the drug company and the HSE to engage to try to find a way forward that will provide certainty and clarity for that patient group. I will undertake to continue to liaise with Deputies Kelly and Brassill. I ask that as much focus, effort and responsibility is placed on the drug company as is on the HSE because it takes two parties to result in a successful negotiation.