I want to raise a situation that is essentially a matter of life and death for a number of people in this country. In particular, I have been approached by Mr. John Duggan from Meath and people representing Ms Mary Gorman from Ballinakill, both of whom have been denied Soliris, a drug therapy which can have a dramatic impact on patients with a rare blood disorder.

The condition, that affects quite a small number of people globally, is paroxysmal nocturnal haemoglobinuria, PNH. It is a rare acquired blood disorder which is severely life-threatening. Some 35% of patients will die within five years of diagnosis and 70% of patients will end up with end-stage renal failure. It is a very serious issue for those concerned.

As for the clinicians involved, Dr. Philip Murphy, a consultant haematologist in Beaumont, has written to Mr. Duggan. He has consulted both Professor Peter Hillmen, the leading United Kingdom expert, and Professor Paul Browne, who state that this drug is essential for such patients and John should be in treatment with this drug therapy, Soliris.

In 2010, it was decided that ten patients with this condition would get the drug and ten patients, since 2010, are in treatment under the drug therapy, but over the past two years new patients coming onto the scene are being denied the drug by the authorities. As Dr. Philip Murphy stated in his letter to John, there is a strong moral, ethical argument that the HSE should agree to fund the Soliris therapy.

Ms Mary Gorman had to go on "Today with Seán O'Rourke" to highlight her case because she has been left for two years with no treatment to control her disease even though medical experts want her to be treated appropriately. She has had to give up her job. She has been subject to fire-fighting interventions, such as frequent blood transfusions. She is now severely restricted.

The National Institute for Health and Care Excellence, known as NICE, in the United Kingdom has issued guidance on this drug, stating that its impact is a step-change in the treatment of this condition, that it offers patients the possibility of avoiding end-stage renal failure, dialysis and kidney transplantation as well as other organ damage, and that the analysis from all sides indicates that the substantial quality-of-life gains made are of a magnitude rarely seen for any new drug treatment.

By any yardstick, it is unacceptable that these individuals have been left without access to this drug. I acknowledge it is a very expensive drug, but it is not the Taoiseach's role and the Government's role to play God with people's lives. I say that sincerely because if these cases were not raised in the public domain, we would not be having this debate.

I put it to the Taoiseach that the defence of the Minister last evening, that it is a matter for others and not the Minister, is not acceptable. Ten patients are already on this drug. The authorities have approved it for ten patients, but a decision has been made not to give it to Ms Gorman and Mr. Duggan, and I would like to know why. How can we in this society state some citizens are more equal than others?

Last night the Minister stated that the €1 million involved could do a lot of other things. The bottom line is it can do a lot of other things but in this instance, it can save two lives and dramatically transform their quality of life. I ask the Taoiseach to cut through the bureaucracy and get this issue sorted, and facilitate access to this life-saving drug therapy for those concerned, who need it and whose clinicians state it is essential that they get it.

I thank Deputy Martin for raising this sensitive and personal matter. I have no intention of attempting, as he stated, "to play God". It is neither my function nor, obviously, within my authority. I can understand the situation here for the people who he mentions.

Deputy Martin stated that a decision has been made not to provide treatment by this drug for the patients involved here. A decision was made to have a pilot scheme of ten patients and ten patients were nominated, I assume, through medical or clinical channels for that.

I understand that the cost here is in excess of €200,000 per person. Obviously, it is a very expensive drug. It is not the first expensive drug. In proportion, we have had similar ones for cystic fibrosis, and there is the cure now for hepatitis C. These also are expensive drugs in proportion, with a significant backlog in many of those cases.

This matter was raised yesterday by Deputy Helen McEntee here in the House as a Topical Issue and was responded to by the Minister for Health. My understanding is that representatives of the company involved were here for a couple of days and have had discussions with the Health Service Executive.

I am not privy to the outcome of those discussions. The opportunity exists to see what can be done in the cases of the two people mentioned by Deputy Martin, or others who are in the same category. The Deputy will be aware that it is never the intention of the Minister, the Department or the HSE to attempt to deliberately rule anybody out for treatment that can affect their lives for the better or in some cases it is virtually a matter of being able to have a longer life than might be expected. As I understand it, those discussions have not concluded. In fairness, they do want to see the outcome of the pilot scheme that is currently under way with the drug involved at its current cost.

It will be too late.

It is a matter of which the Minister is well aware. Yesterday, he responded on the matter to Deputy McEntee and for the information of the House. Arising from the Topical Issue that was raised, I would like to think the discussions that were under way between the HSE and the drugs company in question might be able to go a little further. I would like to think the people Deputy Martin mentioned and others who are caught in this particular problem could be facilitated. Unfortunately, there are so many other areas of equal priority in people's lives for access to drugs of proportionate cost who look for the same facility. I have no intention of attempting to say one person can have access to a drug and another person cannot.

The Taoiseach is the boss.

The Taoiseach should do something about it. He has money for museums and roads.

There is only a certain allocation one can make. A pilot programme was introduced for ten people to see the effect of the drug treatment on the quality of their lives. I will bring the matter raised to the Minister's attention, as it was brought to his attention by Deputy McEntee yesterday evening.

That answer is simply not good enough. The Taoiseach is the boss.

Deputy Martin was the boss at one time also.

In 2010, Fine Gael Deputies rightly raised the issue of this drug therapy in the Dáil with the then Tánaiste and Minister, former Deputy Mary Harney. According to the letter from Dr. Philip Murphy, he said that initially the HSE agreed to fund ten patients with PNH but despite attempts by him to get the funding agreed in the past two to three years, he recently had correspondence from Shaun Flanagan, chief pharmacist of the HSE, to the effect that he is not in a position to fund eculizumab therapy for any more PNH patients at present. It is a funding issue.

It is as simple as that.

It is not, as the Minister tried to indicate last night, to do with the efficacy of the drug. There is no issue with the efficacy of the drug according to the leading clinicians in this area around the world. What is happening is that the position has hardened in the past two to three years in the health area, and for innovative drug therapies. The consequence of that is that two citizens of whom I know, and there may be a third or fourth, are being denied drug therapy of which ten other citizens have been availing for the past three years. That is not acceptable on equality grounds. It is a life and death issue. There will be extra costs on the HSE when renal failure, thrombosis or the other side effects of this particular condition occur. Extra costs will also result from the regular blood transfusions that will become more frequent as the condition deteriorates. In one case, a person has had to leave her job because of the failure to enable her to avail of this particular therapy.

This is a funding issue. I mentioned the National Institute for Health and Care Excellence, NICE, in the UK, which is not known to be flaithiúlach in its approval of new drug therapies, but the institute is clear that the drug therapy in question is a step change in treatment for this rare condition and disorder. It is about time the Minister took responsibility and stopped hiding behind other authorities such as the HSE when it is a matter of life and death. The matter is urgent because the longer it goes on, the higher the risks become in terms of something very serious happening to the people concerned.

The reason I raise the issue is because I want to see action arising from today.

Hear, hear.

The story has changed in the past eight to nine days. Senator Thomas Byrne was told in the Seanad last week that the discussions with the drug company had ended and there was some drug company bashing. We do not need any of that. We need the Minister to take an approach that is hard-nosed, with his sleeves rolled up to ensure that patients can have access to a drug therapy that can transform their lives. Once they are on the drug therapy, their lifespan would be equal to any normal situation.

I would like to think we could live in a country whereby these situations would not have to arise in the first place. I would like to think that people who suffer from life threatening ailments, be they cancer, a heart condition or whatever else, could receive treatment, drug treatment and medical attention much more quickly.

In response to Deputy McEntee's question yesterday evening the Minister pointed out that, as the Dáil is well aware, the Health Service Executive has statutory responsibility for decisions on pricing and the reimbursement of medical products under the existing community drugs scheme. As Deputy Martin is well aware, the drug is for the treatment of people such as Mr. Duggan with PNH and it is considered to be one of the most expensive drugs in the world.

What price is a life?

Alexion Pharma is the company responsible for the drug. It has been engaged for some time in trying to arrive at a price that would assist the HSE in its desire to fund this medicine for people who need it. The HSE has been very adamant about that. The company is not that easy to deal with. We would like to think that this measure could be accommodated within the resources available. That is the reason, given the responsibility the HSE has for drug pricing and reimbursement, it must engage properly with the company producing the drug. My understanding is that the price being offered at the moment would involve the medicine in question costing €420,000 per annum for each additional patient that is treated. It is one of the most expensive drugs in the world. One cannot put a price on a life but the Health Service Executive and the Department have a responsible position to engage with Alexion Pharma to get the best deal possible for taxpayers but more fundamentally for the patients who need such treatment. The discussions between Alexion Pharma and the HSE have concluded and the HSE is now considering the outcome of those discussions and of that engagement. It is regrettable-----

It is always the same old answer.

-----that the company has not been able to provide the drug at a more sustainable price to the Health Service Executive to reflect the clinical evidence we know exists.

Bash the drugs companies.

I would have thought such a company, given that we have a pilot programme for ten people-----

It is not a pilot programme. That is a misnomer. One either has a clinical trial or not.

The Taoiseach should be allowed to conclude.

It is about ten lives as well and I cannot discriminate or make a decision-----

The Taoiseach is doing so. Ten people are on the drug and two are not. That is discrimination.

It is naked discrimination.

The Taoiseach is doing so.

I cannot make a decision between one life and another. As Deputy Martin said, I am not acting here-----

Two hundred people in the UK are on the drug therapy. What we are getting in response from the Taoiseach is not good enough.

Deputy Martin.

I am sorry but we must conclude the matter.

If Deputy Martin wants to make political points about what he says is a matter of life and death, then he should continue to do so.

The Health Service Executive, quite rightly, has engaged with Alexion Pharma, the company who produced this drug. It is a drug that has given great comfort, ease and extension of life to people-----

Two people need it.

It costs €420,000 extra per annum, per patient. The Health Service Executive is right to engage with the drugs company because it is the body that must deal with drug pricing and reimbursement for drugs. The HSE has concluded those negotiations. In view of the fact that this matter was raised by Deputy McEntee, Alexion Pharma-----

It was also raised by Senator Thomas Byrne in the Seanad.

-----should listen to the points that have been made in the House and perhaps it might arrive at a more acceptable price regime so this medicine could be available not just to the two people referred to by the Deputy nor solely to the ten people on the pilot programme, but to others who are in this category. I hope that Alexion Pharma listens to the voices raised in the Parliament today.

So it is their fault.

Order, please.