Bernard Durkan (Kildare North, Fine Gael) | Oireachtas source

It is unlimited. This issue was mentioned in passing at a meeting I attended in Vienna yesterday. I am aware it is coming up today in another context. There are two things I want to deal with. First is the emotional element and the life-or-death situation. As Deputy O'Connell said, it is down to whoever can exert the most influence or shout loudest. The problem is that individual patients who find themselves confronted with a particular condition see no way out if they cannot access treatment. They find it particularly upsetting if the treatment is available selectively. It is also unconstitutional. That is the reality of life. It is unconstitutional to prescribe something for a group of people, assuming there are no other barriers, clinical or otherwise, and not to approve it for another. It is as simple as that. I hope it is being borne in mind because not only is it unfair, it is subject to there being no other medical reason as to why they should not avail of it or have it made available to them. They are entitled to it under the laws of the land. It should be borne in mind.

The job this group does is a very difficult one. I have no doubt about it. It is torn in all directions. There is one thing missing. I have spoken about it many times. Everybody else has spoken about it today. If I were asked to find out what impact the cost of a particular drug will be on the budget, which is an issue, I would like to find out from the people who know. I would presume I could press a button and find out where the drugs were being used throughout Europe and what the cost was in each case.

I do not agree with the principle of lying downwind in the negotiating process until other countries have gone ahead. That is not the way to do it at all. The market of 500 million people in the European Union should be used. It should negotiate a first and last point. We should use the weight of the 500 million people the European Union represents. The European Union is there to back that up. I cannot understand why it is not the first port of call. It should be the first reference. It should not be to the country that has negotiated successfully individually. There is an institution for doing it so why does it not happen? Why does it not happen in a way that is most beneficial to the patients and the cost of the delivery of the services? The only way it can happen is by reference to the biggest single market of which we are but one. We are only 4 million out of 500 million. We discussed this 25 and 30 years ago and arrived at this conclusion before the European Union was what it is now. To what extent do we now use that reference when coming to a conclusion on the suitability of the drug for all patients, the cost of the drug and recognising there may be variations in patient reactions?

I would like some clarification about biosimilar and generic drugs. I was around at the time when this discussion initially took place. Many patients reported that generic drugs did not have the same impact, but the clinical experts told them that they were wrong and that it was just their imagination. Does the Chairman remember that? As legislators, we were in a difficult position. We did not know who was telling us what they thought was the truth and what was accurate. Legislators can only work based on the information they are given. As such, I would like a clear indication of the extent to which those two thought processes have been merged to give us some idea as to what we should be doing in future while also keeping costs in mind.

I cannot believe that we are still using 14 reference countries. It is all nonsense. It gives an average, but we know how averages are determined, so we will not go into that. For God's sake, can someone somewhere initiate a method whereby we can have a reference to the best possible people in the drug-buying business? The drug companies will, of course, give drugs to some people for free to prove they are effective and to make a bargaining position when dealing with people like the witnesses. That is what they do and that is the commercial world in which we live. There is no use in pretending that it does not exist when it does. It is up to the HSE to set up a structure whereby it can determine which drug is the safest and most effective and appropriate and what is the best value at which it can be purchased so that patients in Ireland pay at least the same as they would in other European countries.

I have many further questions, but I will finish shortly. How does the cost of Orkambi compare across Europe? It is a simple question. I know that the cost varies, but by how much? Why does the Irish patient not have the same access to it as everyone else? I cannot understand that.

In recent weeks, eight drugs were approved at a cost of €300 million over five years, or approximately €60 million per year. Out of interest, how does that compare with the drugs that were reviewed five years ago, two years ago and now in terms of their efficacy and cost? What is the cost per patient of Orkambi? What is the European opinion on its efficacy, that is, its ability to treat all cases, most cases or specific cases? Do situations arise wherein it is possible to determine, based on the analysis of the patient and his or her condition, the drugs that are most likely to work, given the patient's metabolism? I would like to think it is possible. Two patients with the same condition may have metabolisms that are at variance with the norm.

My final question is a general one. I am not a medical expert, but I know of patients whose screenings for cancer have been deemed clear or not clear, whichever the case may be, but whose diagnoses have changed over a period for reasons that are not readily explicable. Is it possible to shed some light on this? The cervical smear test is not diagnostic, but a screening process and its accuracy can vary dramatically. The claim that it is 80% accurate is very misleading from the point of view of the patient because the patient will always believe-----