I would like first of all to welcome very much the fact that this Bill is one of a series of Bills coming to the Seanad before the Dáil. As other speakers have said, I hope we in ths House can do justice to it. It is a Bill which in party-political terms is non-contentious, but in terms of vested interests outside the House, very contentious indeed. I hope this Bill, like other Bills such as the Archives Bill, will be amended in this House and will go to the Dáil in a different form which will give this House an important role in the Oireachtas which it has not had before.
In prefacing my remarks on this Bill I should say I am sorry one of the strange facts of the composition of this House is that there is only one doctor in it. The other House has a large number of doctors in it. We had a contribution from Senator Robb last week. I do not know whether it is a good or a bad thing, but we cannot put any great expertise into the discussion of this Bill because of the lack of medical people in this House which is unfortunate but cannot be helped.
I welcome the principle of the Bill like everybody else who has spoken. I recognise the motives of those who wanted a Bill of this sort. I welcome their wish to protect healthy volunteers who are undertaking clinical trials because that is the motive behind the Bill. In practice, I am afraid I would agree with those speakers on this side, the Opposition side of this House, who find that the details of this Bill have turned out to be completely unacceptable. The Bill seems to be — although I am assured to the contrary by those who were involved in the drafting of it — a reaction to a particular tragedy known as the Rush case. That is what the public perception of it will be because there was enormous public disquiet as a result of that tragedy. That case certainly pointed to the need for statutory controls over clinical trials which we do not have at the moment.
I am afraid this Bill is a devastating over-reaction to that Rush case. In their wish to protect healthy volunteers undergoing clinical trials, the Government — and those who drafted this Bill — have done a large amount of damage by obstructing medical progress. One only has to look at the vast number of submissions which Members of this House have already received from the medical profession, from research institutions, from the universities and from other interested bodies, all unanimously hostile to this Bill and worried about it, all welcoming the idea of protecting those who are undergoing clinical trials but feeling that this Bill in its present form will obstruct medical science and research in this country, although it was not intended to do that at any stage. That is why I hope it will go to the Dáil either amended or in a completely different form.
I cannot believe what I have heard from many doctors. I would like to know what consultations the Department had with doctors on this. With whom did they have discussions? The submissions I have received would indicate that the consultations with the medical profession were very scanty. If there had been serious consultation with the medical profession there would not be the sort of irate, alarmed protestations which we are receiving at the moment from that profession. There probably was a certain amount of hurry, a certain amount of rushed drafting of this Bill which has created a precarious and dangerous situation for medical progress in this country.
The emphasis is rightly on the protection of those who are undertaking clinical trials but there is very little balance in the Bill. If it is to mean anything it has to be balanced or it ought to be withdrawn. The consequence of this Bill could well be, in obstructing medical research, the opposite to what its intention is. The consequence of obstructing medical research could well be that there will be more deaths in this country rather than less. The consequence could be that in trying to protect those who undergo clinical trials we actually obstruct medical progress and cause more deaths as a result.
Drug testing is a very emotive subject. I listened last week to some of the speeches, including Senator Brendan Ryan's very good speech, which were antagonistic to the sort of drug testing which is going on in this country at the moment. He mentioned the sort of people who were often the objects of these clinical trials. It is regularly and often rightly said that it is the most vulnerable in society who are being subjected to these tests, that is, the poor, the homeless, the unemployed, the weak and the under-nourished. I think that is true. Without any doubt the majority of those who are undergoing these tests are from the under-privileged sections of our society. I went down recently, to the Institute of Clinical Pharmacology, about which there has been a great deal of controversy, to see how that institute worked. First, I have no doubt as a layman that the standard of medicine, care and cleanliness was absolutely impeccable in that place. I also did a spot check by going down to interview some of those socalled volunteers for these clinical trials. That was extremely interesting, and it bears out some, but not all, of what Senator Brendan Ryan says. The majority of those to whom I talked were unemployed, but not all of them. I talked to about 12 people and ten of them were unemployed. Two of them were doing it because they had time off for various reasons and they wanted to earn some money. Very few of them were in the slightest bit fearful about what was going to happen to them. Those going for the first time were apprehensive, as anybody would naturally be.
I understand the criticisms of those who say that this is immoral because they are doing it for financial inducements — not for much financial inducement but because they are vulnerable, poor and need the money. Senator Ryan's very valid point was that they do not make a free choice because they are under financial pressure. That is true, although I am not sure that anybody ever makes a free choice about anything because he or she is under some pressure, but everybody who has spoken on this Bill has accepted that these tests are essential, that you cannot scrap them, that you must test drugs on human beings.
If we are to condemn the system as it works at the moment at the Institute of Clinical Pharmacology or in any other of these institutes, as a society and a Government we will have to produce a different means of testing. We will have to put an obligation on certain human beings to subject themselves to these trials. Maybe, as was suggested to me when I went down there, every citizen should give three, four or five days of his or her life towards these clinical trials. Maybe citizens should have the same sort of obligations to this as they have to jury service. Maybe everybody should give a very short period, a few days of his or her life undergoing these clinical trials in order to benefit the rest of mankind. Maybe we should look at such a system, but let us not criticise the system which works at the moment unless we have a substitute. Those who go there may not like what they are doing, but they are doing it voluntarily. It is patronising to say that the unemployed cannot give true consent because they are under financial pressure or because they cannot read. In my experience there it was fully explained to them the tests they were going under, how long they would be there, what the effects were likely to be and everything else that they asked. It is absurd to say that because they are underprivileged they do not understand and cannot give full consent. They may be under greater pressure, but it is highly patronising to say that they cannot give full consent. In my experience they know exactly what is happening to them. A calm assessment is what is needed. We should stand back and look at the system of clinical trials on human beings.
To dispel some of the fears expressed, let me say that all of them are examined after they are discharged. This is important because many have felt that, although they do not suffer or very rarely suffer under the influence of these trials because they are receiving very close medical attention, may be they go off and suffer after-effects. That may or may not be true, but I know that following their discharge they are all assessed by an independent physician who is not in the pay of the clinic involved. They are safeguarded in that none of them is allowed to do more than three trials per year and if they reappear for a second or third trial or at any trial subsequent to their first they are thoroughly examined to see if there are any new medical reasons why they should not undergo this trial or whether there are nay after-effects from the last trial.
Therefore, it would be unwise to be hysterical about what is going on. It would be right to be careful, circumspect and vigilant, but I do not feel that these institutions which we are talking about are the sort of wicked ones that they are portrayed to be, the exploiters they are and have been portrayed as being by some Members of the House.
Certainly they are making money, and that is a different matter. We must decide whether people should be allowed to make money out of clinical medicine, whether it is moral for pharmaceutical companies to pay large sums of money to doctors to find out the effects of certain medicines. If people can produce alternative methods to this House or anywhere else, let them say so and let us look at them, but at the moment that is the system as it works and, to the best of my knowledge and, obviously, in the belief of most Members of this House and those who drafted the Bill, it is contributing to the saving of human lives in this country and abroad.
Balance is lacking in certain places in the Bill, where medical research is being impeded at the expense of the medical profession in research. The first point in this has been touched on by other Senators regarding the ethics committees being set up. In several of the submissions I have received doctors are up in arms about the ad hoc nature of these ethics committees. According to this Bill ad hoc ethics committees should be set up for each trial. In not only my opinion but in everybody's opinion, this will lead to enormous and excessive delays. Every single trial will have to have a new ethics committee set up and they will have to discuss things and come up with a verdict. It will take time, it will impede medical progress and it will impede chemical trials. That is not satisfactory. That is clumsy and absurd. I do not see why this should be put in the Bill. I suspect that it is because of the Department's and the Minister's real concern about each test and their wish to monitor it, but I think that they will find (a) this is unnecessary and (b) it is obstructive.
Secondly, the Minister must give permission for each of these ethics committees to be set up. This appears crazy. For the Minister to examine the ethics committee and the trial and then to give permission will, of course, delay matters. What I would like to see put in the Bill, if the Bill is to stay at all in this form, is the criteria the Minister is going to use under section 7 (1) for saying yea or nay to these committees being set up.
The other objection I have received to the ethics committee is a very strange one, that is the excessive influence which the applicant, the person carrying out the trial, will have on the composition of the ethics committee. This seems a very unfair and unbalanced way of setting up ethics committees. While on the one hand the Minister wants to set up impartial ethics committees with no vested interests in the trial, independent ethics committees, it then appears, according to this Bill, that the applicant has the right to nominate the members of and the right to apply for changes in the ethics committee. It would be far more sensible if the ethics committee were to be nominated by a totally independent body — the Minister or people who have no vested interest in this trial. It seems absurd that the person who wants to carry out the trial is also nominating those who will say what he can and cannot do.
One of the great disadvantages of this Bill is that ministerial power is too great. While I do not begrudge such power to this Minister for Health, who has been a very good Minister for Health in my view and who would not abuse it, in terms of precedent and in terms of the future, it is wrong to give statutory long term permanent ministerial power of this sort to anyone. If anything, we should try to reduce ministerial power rather than increase it, especially because the Minister will not have time, and he will not necessarily have the expertise, to judge when an ethics committee should be set up and when a trial should or should not be allowed.
The best solution to this problem is that standing ethics committees should be set up in those institutions which would, in the normal course of events, be applying for permission to the Minister to do a clinical trial. These standing ethics committees should be set up in hospitals, research institutions, universities, etc, to judge every single individual trial as it appears in those particular institutions. This would mean there would be no delay. If, say, there was one such committee in Dublin University and in each individual hospital, then the individual doing the trial in that institution could immediately apply to the standing ethics committee which is there in situ. This would avoid the whole business of applying to the Minister, with the Minister watching the ethics committee being set up and then approving it. Goodness knows how long it will take for the trial to actually take place after that.
There has been a great deal of resentment about the fact that the National Drugs Advisory Board have been left out of the Bill. Instead of the function and the role being played by the National Drugs Advisory Board, most of these powers are handed to the Minister and indirectly to the Department. While the Minister said in his Second Stage speech in May — and I do not for one moment doubt his word — that it was his intention to consult with the NDAB, I do not think this is good enough, because it gives no statutory role to the NDAB. I believe the NDAB are a distinguished body who acquitted themselves extremely well in the past and should not have been treated in this fashion. The NDAB, on their record, deserves a statutory role. Whatever assurances the Minister gives us that he wishes to consult them on this — and I am sure they are given with the best of intent — we cannot make law on the basis of one Minister's assurances of consultation. The NDAB should be written into the Bill and should be given some of the powers which the Minister has taken on himself. They are the body who should consider the applications for clinical trials, not the Minister and indirectly the Department.
The Bill could be amended, if it is not withdrawn, on this particular issue to specify what would justify a refusal by the Minister to allow a clinical trial, because in this Bill the Minister can refuse without giving any reason. The Bill could be amended to require the Minister to give reasons for his refusal. In other words, if he says no to a clinical trial then he must publicly state why so that the medical profession can know what the reasons are. The logical follow on to that is that an appeals body should be set up if this system is to continue as it stands in the Bill at the moment. In other words, when a refusal is made public, the Minister must be required to give his reasons and the applicant for a clinical trial can then appeal it to another body. Lastly, the Minister should spell out the criteria which ought to be used beforehand in deciding whether clinical trials are to be allowed. While the Bill is too wide it is also too vague and gives too much power without any accountability. I hope there will be Government amendments rather than independent amendments to change this on Committee Stage.
The medical profession has been alarmed at the width of the Bill and the enormous depth to which the Minister casts his net in this Bill. Some interpretations are that it will take in all dietary studies, studies of medicines which are already on the market. I believe this was probably unintentional. It would be far too wide if those conducting clinical trials had to apply for permission to carry out tests on diets, on asprins, or on other pills which are already on the market. There does not appear to be — and this is very necessary — any distinction between new drugs, which will obviously have to be subject to the most stringent controls and drugs which are already well established and on the market. It is absurd that the drugs which are established and approved by the NDAB as harmless in many ways should have to go through the same process as those drugs which have not been established. I hope these problems will be dealt with on Committee Stage and that a distinction will be made between the two.
The Bill appears to have been drafted for healthy people who are volunteering to test various drugs, not the sick who are the subject of clinical trials. It does not appear to cover those who are terminally ill or those who are ill with serious diseases. It appears to rule out many trials which are absolutely necessary not only for the sick but for the medical profession who want to find out how to relieve pain and suffering. In this sense we are completely out of line with international thinking and the laws in the European Community.
The main objection to this Bill is the bureaucracy which would be involved and the obstruction to medical research which would result. Under this Bill the Minister is required to give permission "as soon as practicable" for a clinical trial. That is unacceptable to the medical profession; it is unacceptable to the nursing profession; and it is unacceptable, I am sure, to those who are undergoing these clinical trials because "as soon as practicable" in the Bill means absolutely nothing. It means when the Minister feels like it. That could mean a week, a year, two years or five years, or the trial could be indefinitely delayed. The Bill should specify a fixed period for this permission to be given. I would like to see in this Bill a fixed timetable of stages with no vague periods leading to delays. Under this Bill the Minister should have to give permission within a certain time. The medical profession suggested 28 days but that may be too short. If there are too many applications it may be difficult for the Department to process them all within 28 days, but within a very short period of time it is not unreasonable to ask that this should happen. Otherwise they will be left in files, requests will sit on shelves and complicated applications will not be tackled. We should not give a Government or a Department and excuse or an out of this kind. If they are going to take on this responsibility — which I do not think they should have — they should be made to exercise it within a reasonable time. This Bill, while it gives them the responsibility, also gives them an out and they only have to exercise that responsibility when they feel like it. In reality the Bill gives them an out not to exercise that responsibility because "as soon as practicable" means that they can delay it for as long as they wish and they do not have to make any awkward decisions.
There is no time limit on the Minister's approval of the timing of a clinical trial, of the composition of an ethics committee or the deliberations of the ethics committee. It is important, without putting a gun to their heads, without rushing this very serious business, that there should be a timetable. These trials are urgent, they are matters which are directed towards relieving pain and saving lives and it is important if this work is to be done that it should be done to a timetable.
While I welcome the intention behind the Bill, it has serious drawbacks to the promotion of medical research and will be a massive and major impediment to medical research. This is the belief of many doctors from whom I have received submissions. It is suitable only in protecting what are known as phase 1 volunteers, healthy volunteers on new drugs. However, it is unsuitable in its present form in regard to established drugs. It is unsuitable to those who are sick or terminally ill. It is totally unsuitable to medical school students where it is normal practice that trials should be carried out under strict supervision. It is totally unsuitable to dietary studies. It is the right idea, the right motivation, but it is so wide that it would be an impediment to medical research.
