Last Friday, with Deputy Billy Kelleher, I met a group of Alpha-1 patients who were on the drug Respreeza and who told us their stories and individual case histories. From 2006 onwards they had been part of a clinical trial involving the drug, which slows down the progression of emphysema in patients with severe Alpha-1 deficiency. From 2010 onwards they had been part of a compassionate access programme which had been ceased by the company, CSL Behring, in September 2017. Following discussions the company made the drug available again, but the HSE refused to administer it. There was an unedifying impasse and in the intervening period two patients, Anna Cassidy and Marion Kelly, died. A compromise was then reached. It will last until May. All of the patients I met had been on the drug for years. All had reported the benefits of the drug for them, to which their families testified. I met Marion Kelly's sister, Niamh. Marion had been the youngest of the cohort of patients who had benefited hugely from Respreeza. Niamh Kelly said that when Marion had come off the drug, she deteriorated rapidly. All of the patients I met had deteriorated rapidly once they had come off the drug. Anna Cassidy and Marion Kelly should never have died. That they did is a very sad reflection on all concerned - the company, the Government and the service provided. They died while there was an unedifying row taking place and the drug was lying in a warehouse. A third party is administering the drug as part of the compromise reached.

There are articles in The Lancet and The Lancet Respiratory Medicine which confirm the efficacy of the drug in slowing down the progression of emphysema in the cohort of patients in question. In the United States 6,000 people are on Respreeza, while the authorities in Germany, France and large parts of Italy reimburse the cost. As the European Medicines Agency has approved the drug, why has Ireland not done so? Professor Noel G. McElvaney in Beaumont Hospital has been the lead clinician in this area for quite some time. Why do we ignore his expertise? He is the only European member of the Alpha One Foundation. The Minister for Health has said he wants engagement and asked the HSE to engage with the company. It has not engaged. There has been no engagement. Will the Government intervene to ensure a physical meeting will take place between the company and the HSE to have the issue resolved and ensure reimbursement will take place? That is the only way the matter can be resolved. If it is happening all over Europe and the United States, why is it not happening in Ireland?

I thank the Deputy for raising this important issue. I do not have a note on it to hand, but I have some knowledge, given that the matter has been in the public domain and from discussions I have had with the Minister for Health about it. It is the policy of the Government to endeavour to ensure patients in Ireland will have access to new medicines. That has been our policy for a very long time, but we also have a duty to make sure medicines are effective and that the price taxpayers pay for them is reasonable in order that more people can be treated and more services made available to patients who need them. It has been set out in legislation for quite some time that the Government does not decide on which medicines should be reimbursed. That is decided by the HSE's national drugs committee which takes the advice of the National Centre for Pharmacoeconomics. There is expert advice which is put together by doctors, pharmacologists and economists - people who know about these things - who pass it on to the HSE's national drugs committee which then makes a decision on whether the cost of a medicine should be reimbursed. As the Deputy will be aware, decision on reimbursement is not the same as a decision on licensing. That is the process involved.

We have had some interesting discussions in recent weeks on when politicians should and should not intervene in a legal or statutory process. This is a statutory process, of which the Deputy will be aware, because the legislation was passed by the Oireachtas to set up the system the way it is. The experts in the National Centre for Pharmacoeconomics give advice and the HSE's national drugs committee decides. That is how it is done, but that is not to say Ministers cannot request that meetings take place. I will certainly speak to the Minister and ask him to encourage the company to engage with the committee. That would be the right course of action to take.

One very sorry feature of this affair is the way the manufacturer behaved. When a patient is put on a new drug, either as part of a trial or a compassionate programme, it is standard practice for companies not to withdraw the medicine. While a decision might be made not to extend it to new groups or new patients because of efficacy or the high cost involved, it has been standard practice for a very long time for companies to allow patients already on a medicine to continue to receive it. The company in question has behaved very badly and unethically in not providing the medicine for patients already on it. I hope the Deputy will join with me in echoing that sentiment.

The bottom line is that two people have died. The Taoiseach can talk about systems all he likes, but more people will die if the issue is not resolved. The system described by him is not working; it is failing. Professor McElvaney has been the lead clinician in this area for well over a decade. He has worked on the Alpha-1 gene and Alpha-1 deficiency and his expertise has been ignored. In respect of the Helsinki Declaration, about which the Taoiseach spoke, the company was wrong, but, equally, the Government and the HSE were wrong because the declaration is very clear. It states that "in advance of a clinical trial, sponsors, researchers and host country governments should make provisions for post-trial access for all participants who still need an intervention identified as beneficial in the trial". Our side - the Government - is not stepping up to the plate. It can act in a hands-off way all it likes, but that is not going to work. In respect of the insecurity the people in question face when they wait while nothing is happening, what is happening is inhumane. The Minister asked the HSE, but it has ignored him. There have been no meetings and no engagement. The company acknowledges fault and spoke to Niamh Kelly, the sister of Marion Kelly. It is willing and anxious to engage. All we are talking about are 21 patients on the island, but we go on about being hands-off and how it is this and that system. For God's sake, let us bring some humanity back to the health service.

On foot of the Deputy raising the matter, I will speak to the Minister for Health today and ask him to request further engagement involving the HSE's national drugs committee and the company. That is the appropriate way in which to respond on this important issue. I am very much attuned and wise to the humanity and human consequences of it.