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Seanad Éireann debate -
Wednesday, 8 Oct 1986

Vol. 114 No. 3

Control of Clinical Trials Bill, 1986: Second Stage (Resumed).

Question again proposed: "That the Bill be now read a Second Time."

I do not intend spending very much time on this Bill though it is a Bill of major importance. Many people have been concerned for many years about the preparation of drugs and their availability on the market. It is essential that we have control over the means by which drugs are produced. Unfortunately, nobody has yet come up with the ideal solution to the many problems associated with the production of drugs. It would appear, essentially, that drugs are prepared and put on the market after testing, either on animals or on humans or, as happens in many cases, on both animals and humans. Unfortunately, when we have testing involving either animals or humans difficulties will arise and mistakes will be made. Sometimes these mistakes are made because of human error or because of insufficient testing in the area of ascertaining whether the recipient of the drug is a suitable subject for administration of the drug concerned.

I am not familiar with the procedures that are adopted in other countries before drugs are tested on either animals or humans but I am aware that tests were carried out on animals at the general hospital in Boston, Massachusetts, so that the medical people might find out how death by instant heart attack occurs. I felt that the work that was being carried out on these animals was cruel and inhuman though inhuman may be a peculiar word to use when talking about trials being done on animals. I would not advocate such trials. Unfortunately, much publicity has been given to the control of trials on humans. In this country emphasis has been placed on this aspect of drug testing as a result of the unfortunate death in Dublin of a young man during clinical trials. To many it would seem that the controls over these trials were inadequate and that something has to be done to ensure that such incidents would not happen again.

Irrespective of what sort of controls we bring in there is no precise way of controlling what might happen in the future. Nevertheless we have to try to bring in controls which may alleviate any problem that may arise. Nobody would disagree with the need for control but it is the method by which the control is brought in which leaves some apprehension about this Bill.

A volume of literature has been sent to everybody in this House in relation to this Bill. Some of the papers we received have been concerned with professional attitudes. Some deal with commercial attitudes and quite a number of people have been in touch with us in terms of social attitudes and social problems relating to people who become involved in the trials associated with the production of drugs. No satisfactory method has been found yet whereby drugs can be adequately tested unless they are tested on animals and humans. No matter what we do here, we are basically just trying to give effect to the best method of dealing with trials which will be conducted on humans.

The problems associated with this Bill are many and a number of questions have to be asked. A major concern is that proven drugs are being treated exactly the same as previously unknown drugs. It is ridiculous that a drug which has already been proven but which is undergoing a test as to its suitability for other purposes must go through further tests under the same regime as the testing which would go on for drugs which have never been on the market before. Will the Minister have a look at that aspect because it is one which could cause great financial reprecussions within the drug trade.

It is proposed to subject the new drugs to tests so stringent as to render them seriously out of line with all other EC countries. It is proposed to subject to a very strict regime proven or off patent drugs which have been available on prescription to the Irish patient for a minimum of 16 years, even though these drugs would have conformed with all the EC regulations, and passed the trials which have been conducted by the Food and Drug Administration Board in America.

There is a native Irish industry which concentrates itself mainly on generic drugs, basically unproven drugs. It is the stated policy of the Minister and the Department of Health to encourage generic prescriptions because of their cheapness and their benefit to the State, because they are used in an import substitution area. There could be major problems for the firms involved in the production of these drugs if an amendment is not made to this legislation. There are on average between 30 and 40 applications per year from the generic companies to the National Drugs Advisory Board and when they are passed, they get a certificate of free sale in the Republic. More importantly, this certificate conveys automatic free sale in every country outside the EC, EFTA, USA and Canada. Without these certificates our native industries could not export, which is 90 per cent of their business. The generic drug manufacturing companies suggest that if they were to get involved fully under the regime brought in by the Minister, each of these trials would cost in the region of £25,000, because of delays in getting into production due to the test procedures and so on. There is a fear amongst companies such as Antigen who have been here for some time that they would have to pay up to £25,000 to test and produce a drug which has already been fully tested and manufactured to stringent manufacturing standards.

From the social point of view a lot of play has been made about the people who are going to be used as guinea pigs in these trials. It is suggested that 90 per cent of these people come from the underprivileged classes and only undertake these trials to supplement their very meagre incomes and that they are not suitable because they do not look at the reasoning behind the trials, do not look into the dangers associated with the trials and are not in any way capable of assimulating the information necessary to find out whether they are suitable condidates for the trials or indeed whether the trials could be of grave danger to them. Many of the people who would be tested in these clinical trials would be socially deprived. The fact of people being on social welfare or being socially deprived does not mean they are not capable of assimilating information and therefore not suitable. Ninety per cent of people on unemployment assistance or on social welfare benefits would have a very good realisation of the difficulties and the dangers involved in these clinical trials. Some people getting involved in body contact sports and dangerous sports would have a lesser realisation of the dangers involved in these sports than do 90 per cent of the people who are involved in trials.

There must be controls. The National Drugs Advisory Board were the controlling body for a number of years. They have issued the certificates and they have been applauded as being the experts in the area. I cannot see why they should be superseded by ethical committees which would be set up by the companies doing the trials. It would not be fair in a hurling match if one of the teams supplied the referee. It is unfair and unworkable for a company to set up an ethical committee to adjudicate on itself with the Minister coming in then as a final adjudicator. The National Drugs Advisory Board should give the certificates of competency to the drug so far as is possible. Neither the Minister nor his officials, unless the Minister sets up a new bureaucracy, would have the expertise in this matter. To give the Minister the sole responsibility will cause delays, and delays are costly when it comes to manufacturing. The companies who are manufacturing want to get their new products on line as fast as is possible and to wait for a busy Minister to give his signature to a new drug is flying in the face of reality. If it is not to delay matters, it means that we will have somebody in the Minister's office taking over the responsibility, because the Minister will just put his signature to things. It appears as if Mr. Flanagan in the Department is now in charge of everything that happens; he seems to be announcing hospitals. He says he is going to announce his new plans for health within the next five weeks.

It is still the Minister's responsibility.

I am suggesting that the Minister will not have the time to sign and to read the documentation necessary to control drugs, that he will pass it on to some committee or some individual because if he does not he will spend his time sitting down as a drugs advisory board and I would presume the Minister would have responsibilities other than that. The National Drugs Advisory Board are an excellent board and should be left with the responsibility in this matter. They do a very good job.

Nobody has been able under any circumstances to criticise a drug which the National Drugs Advisory Board have passed as being fit for manufacture and for sale. There is in the medical profession a concern about the scope of this Bill which encompasses not alone new drugs but all established drugs in everyday medical practice, including those that can be bought without a prescription, normal food substances and vitamins. Not alone will ministerial permission be required for the payment of the fee for normal medical and dental student education in practical classes, but also for studies involving simple dietary changes. The Minister said these everyday drugs, normal food substances and vitamins are not brought within the ambit of this Bill, but nevertheless there are dietary preparations which can be very dangerous. Even though some of them are on the market and in normal day to day use, they are not under any control at present. Some of them are dangerous and some of them are not. There may be a problem in the area of vitamins. A distinction must be made.

The Minister said doctors who keep a note of the effects of particular drugs on particular patients will not come within the ambit of this Bill. There is within the medical profession an apprehension that that can happen. This would stop day to day monitoring by doctors in their surgeries. If this happens it will have to be replaced by something much more expensive. Everybody involved in the manufacture of drugs appreciates the problems that could arise if they produce something that is not suitable for human consumption. Accidents have occurred over the years as a result of drugs available on the market which are extremely dangerous. This has caused major problems such as the thalidomide problem and a series of other problems. I am not suggesting that they were inadequately tested, but it was proven that side effects could occur and these side effects did not immediately come to the fore. You have to have controls. I do not think that there will ever be a 100 per cent success rate with these controls.

Drug companies naturally want to safeguard their own employment and their own profitability. The only way they can do this is to produce drugs which are safe. Nobody can suggest that the drugs which are under test in Ireland or the manufacturing companies in the generic area have ever created any problems for the public or for people receiving particular drugs. If there is a commercial aspect to this, so what? Are we so anti-profit, anti-job and anti-business at present that we are prepared to take the chance of losing quite a number of very highly paid, highly skilled jobs? There is an element in this Bill which could cause that, not least of which are the new insurance regulations which it is intended to introduce. Anybody in business today who tries to get public liability or specific liability insurance on a limited basis will know the cost of that insurance. It is virtually impossible to get an open-ended insurance policy. Basically that is what will happen if we bring in the type of insurance envisaged in this Bill.

A further safeguard in relation to persons undergoing drug experiments is provided in section 9. This requires that the person arranging for the conduct of a clinical trial must see to it that there is in force a policy of insurance, issued by an authorised insurer, which would be sufficient to provide appropriate compensation in the event of the participant suffering injury or loss. This is nonsense because nobody could judge a participant's injury or loss as a result of trials taking place. The courts and the lawyers could make a fortune out of this during the next few years because anybody who is involved in clinical trials could, because of any medical problem he encountered after that, go to the courts and suggest that his problem was associated with the clinical trial. I cannot see how you can bring insurance into an area where anything else but chaos would exist. It would be a very expensive factor for the people involved in the clinical trials and could be the cause of their going out of business because they could not get the type of cover which the Minister seems to envisage in this Bill.

I cannot see how, within the industry, insurance could be funded. I cannot see that it could be bonded. I cannot see how it could be adequately dealt with because if you are talking about bonding in regard to building you take a specific proportion of the actual contract. When talking about the results of medical trials we will be in the same position as in the States where it is virtually impossible for doctors to practise any more because of the cost of their insurances. Many doctors in the States are "going naked" insurance wise. They are passing over their assets and end up with no assets so that if somebody takes an action against them they have nothing. That is happening on a very large scale. It is happening because nobody knows the limits to which somebody can be sued as a result of a medical accident or medical conclusion.

The Bill is extremely broad. There are safeguards in it which would provide for the elimination of exploitation of people who would be inadequate in the sense of not being able to read the problems which might arise as a result of becoming involved in clinical trials. Nevertheless, the Bill is too broad in certain areas and too confining in other areas. If this Bill goes through as it is presently constituted it would have major repercussions. The repercussions would not be beneficial to the people who would be going for clinical trials, to the industry which is involved or to the Irish people. For that reason I do not think we should continue with this Bill. It is badly drafted. It is ill conceived in the sense that it was conceived as a result of an incident. A lot more care should have been taken in the drafting of this Bill before it was presented to this House and we should think twice before passing it on to the other House.

I welcome the introduction of this Bill. It is important that we have some controls on all clinical trials. When the Minister introduced Second Stage in this House in the summer the understanding was that his Second Stage speech would form the basis of discussions and response from the many different interested groups and professional bodies. By and large that has happened. The Bill has had considerable notice in the public press. It has been debated to a considerable extent by the health boards and other bodies. In general, many interested sectors of the public have expressed opinions on this Bill. I look forward to the Minister's reply to this Stage. It will set the pace as we go into Committee Stage.

It is important to have controls on all clinical trials. But is it appropriate that the Minister and his Department should control and supervise these trials or that this work and the responsibility be entrusted to an appropriate expert committee such as the National Drugs Advisory Board? I listened with great interest to the debate last week and again today. I know that when this measure was introduced in the summer it did not really come as a surprise to many people here. I get the distinct impression that there were some professional bodies and individuals — the universities and consultants and professors in various medical colleges — who expressed disappointment that there had not been very full consultation on this issue. That is not a great issue at this point. The measure is getting a very full and open debate here in the Houses of the Oireachtas and all interested parties have had the opportunity to speak with Members of the House. I am sure that all the views have reached the Minister. I hope that the fears expressed by the various professional people will be allayed by whatever amendments or changes the Minister may propose to this measure.

I accept that there must be controls over new drugs but how far does this legislation go on all drugs on the market? Do licensed drugs and medicines come under the scope of this Bill? Senator Lanigan has raised many important questions which I had intended to raise. Some consultants have expressed fears as to their future liberty to treat their patients. I should like to specifically ask the Minister if the terms of this Bill relate in any way to the treatment of an ordinary patient in a hospital or is this Bill purely confined to academics or scientists who formally test absolutely new drugs on the market? It is important that there should be a very straight answer to this question. When patients do not respond to a course of treatment, for whatever purpose, does this Bill in any way inhibit a doctor or a consultant from introducing an alternative prescription or medication? I should like to know also if these regulations will inhibit the practice of medicine in our hospitals as we know it up to now.

The various points raised during the debate so far shows that the professional people concerned fear this will greatly change the practice as it has been up to now. Section 9 on insurance is a new regulation which is causing not just apprehension but alarm among people who find it very difficult to continue to face the probability of being unable to get insurance cover to continue in their profession. This is one of the areas where prior consultation by the Department and the Minister would have allayed the fears of people whose situation will be greatly changed when this Bill becomes law.

It is important that the legislation in this area should be updated and the greatest possible protection given to all concerned. It is important that people who work in the medical profession, who work so hard to find new cures for modern illnesses, should not in any way be inhibited. While I accept that there must be the greatest possible controls and constraints, there must be a happy medium whereby scientists, consultants and doctors can be assisted and their role and effort not made impossible. For that reason I should like to make this brief intervention now because it is very important to us on all sides of the House to hear the Minister's reply to this Second Stage debate. I am confident that the Minister, who has shown an aptitude for steering his Department in a very determined way, will meet many of the problems that some people now see as almost insurmountable.

I was listening last week with great interest to Senator Robb who introduced quite a different tone to the debate. So, very much as a layman with very little experience of hospitalisation I wait with interest to see how this Bill stands after Second Stage.

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.

I should like first of all to give a general welcome to the Bill as representing the embodiment of the principle which now seems to be established, that there should be public control of clinical trials. This seems now to be accepted by all parties and all interest groups, both inside and outside this House. I am sure when the matter is discussed in the other House that the same general welcome will be afforded to the Bill. Therefore, anything I have to say should be seen against the background that the Minister can be quite happy that we on this side of the House will give it our usual support, subject of course to the scrutiny of the legislation which is an essential part of the democratic process. In that regard I would like to repeat what I said on earlier occasions, that this Minister has been more willing than most to listen to reasoned arguments in this House and in the other House and to amend Bills where the case was shown to be significant and important.

I would like to home in on three aspects of the Bill, each of which has been dealt with at some length by other speakers. It is not my intention to go into those aspects of the Bill at any great length. In passing Second Stage of the Bill, as I have no doubt we will, it is well that the Minister should be placed on notice of our intention to pursue certain matters on Committee Stage. One of the purposes of the Second Stage of any legislation is to afford the Minister the opportunity of taking the temperature of the various interest groups which are represented in this House and the political parties which overlap and are intertwined with those interest groups and which all together from the patchwork quilt which is Seanad Éireann.

The first aspect of the Bill I would like to deal with is the decision-making process taken by the Minister and how this should fit into the overall structure of the Bill. The second aspect is the problems posed by the representations which we all have received concerning the structure of the ethics committee. The third aspect is the problem associated with the insurance requirements of the Bill. Other drafting points are more appropriate for Committee Stage. It would be helpful to Members if the Minister when replying dealt with the principal points made, so that in putting down amendments, or indeed not putting down amendments if we are satisfied with the Minister's reply, we would be afforded an early opportunity to examine the Minister's point of view on these matters.

Sections 2 and 3 of the Bill contain the proposals under which the Minister should be the person to whom applications will be made to undertake clinical trials and to whom responsibility will be given — whether it is after reasonable delay or as soon as practical is a matter which we can discuss on Committee Stage — to decide whether a clinical trial should proceed. I would like to contrast that with the section of the Minister's speech which was quoted by Senator Mullooly at column 102, Volume 114 of the Official Report of 2 October 1986:

While formal approval will be a matter for the Minister, he will rely on the expert advice of the National Drugs Advisory Board in arriving at his decisions. It is the intention that all applications will be referred to the board for assessment and for recommendations as to any conditions which should be attached to his approval.

That is right and proper. I am not concerned that the National Drugs Advisory Board is not referred to by name in the Bill but I would like to ask the Minister if that is a sensible procedure to adopt. Might it not be better for the Minister to build into this or other legislation a procedure whereby the National Drugs Advisory Board or some body of that kind would adopt a permanent overseeing role with regard to the reception and processing of applications subject, of course, to overall ministerial control and direction? I am not suggesting that the Minister should divest himself of the power which he proposes to take, that he should not have the power either to accede to or refuse a clinical trial but because the Minister has that power it does not mean that he cannot establish and pass on to a subsidiary body the day to day decisions which can be taken, retaining to himself the overall control. The Minister should give serious consideration to that compromise suggestion between those who believe that he should exercise total control and those who believe that the control should be exercised independently by a body such as the National Drugs Advisory Board.

The Minister would be well advised to ponder what happened over planning permissions. He will be well aware that originally a Minister got himself involved, as a result of the Planning Act, 1963, in the day to day planning decisions. The burden of that decision, in particualr the burden imposed by the courts in directing that the Minister, or his Parliamentary Secretary, had to personally consider each application, was that an obligation was imposed on the Minister which overwhelmed him politically and physically. Eventually, for that and other reasons, the Minister had to shift this responsibility to the Planning Appeals Board while retaining to himself certain rights and privileges to even overrule, direct or instruct in one way or another the Planning Appeals Board. The Minister for Health may find himself in the position where he will have to consider every application and in those circumstances I wonder if this is wise. I am not suggesting that the Minister should not have the power to do so but I am suggesting that the Minister should seriously consider the establishment of an intermediate body to process the overwhelming number of applications which will be of a non-controversial nature. He should reserve to himself either items which are referred to him by that body or, alternatively, items which he thinks are important and should be taken away from that body so that he can consider them with the expert advice available to him in the Department. That is a point the Minister should give very serious consideration to.

I recommend to the Minister that before Committee Stage he should look at the judgment in that case which related to the period of office of Minister Tully. I do not remember the individual case but it related to a ministerial decision. The effect of it was that the Minister was questioned in court and had to swear, as he did because it was true, that he considered the application. In those circumstances the Minister might address that problem and, even if he is satisfied that he does not have to personally examine each application, there is a very strong case to be made for the transferring to the National Drugs Advisory Board, or some such other board, the routine decisions which form an integral part of this worthwhile process.

The second point I should like to make to the Minister is one which has been referred to us by the various interest groups who have lobbied us in this regard. I welcome such representations. It is entirely appropriate that they should take place. I regret that many other interest groups are not as organised to present their point of view because it is only by hearing the point of view of those people who are involved on a day to day basis that we can arrive at a consensus of what is truly in the national interest.

The Minister in section 2 (1) proposes:

A person who proposes to arrange for the conducting of a clinical trial shall apply to the Minister for permission...and every application...shall be accompanied by — (b) the names and respective qualifications of the persons proposed as members of the ethics committee for the clinical trial.

This has been assumed to mean by those interested and, indeed, by most Senators who contributed to this debate that ethics committees will be proposed on a one by one basis, that each person who wants to conduct a trial will propose their own ethics committee. The Minister may well say, and he may be right, that over a period of time certain people will acquire an expertise in this area and will be nominated frequently on committees of this type.

Under section 7 where the Minister is satisfied that a proposed ethics committee is competent to consider the justification for a trial he shall give approval to the proposed committee. However, the power rests by and large with the person who proposes the names in the first instance. I realise that the Minister has the power to refuse but in the nature of applications of this kind the tenor and structure of the committee will to a large extent be determined by the original list sent to the Minister. The Minister will find it impractical to start ruling out as ineligible a substantial number of those people who are proposed for the ethics committees and on a realistic basis, the ethics committees will over a period of time be at the choosing of those who propose to conduct the clinical trial. It certainly will happen where a panel of people who have served previously on ethics committees is built up that the choosing of eligible people from that unofficial panel will become a matter for the person who proposes to conduct the clinical trial and the Minister, having previously approved each individual proposed, will find it difficult in that particular instance not to approve them.

Therefore, the structure of the committee, and the personnel of the committee, can be unfairly influenced by the person who proposes to conduct the clinical trial. The Minister is, of course, aware that suggestions have been made to the effect that it would be more appropriate if a central and semi-permanent ethics committee or committees were established from which the Minister, or indeed the person who proposes to arrange the trial, may draw or, alternatively, that a body like the National Drugs Advisory Board should, in addition to being given the power as a matter of routine to approve of clinical trials, be given the power at the same time as so approving to approve of an ethics committee suitable for that trial. In that way a permanent ethics committee for each area of activity could be built up which would be independent of the interests involved in the proposed clinical trial.

The Minister has a case to answer on that. I am not saying the Minister cannot answer the case but the case requires serious consideration. I would be very interested to hear the Minister's response to that second point.

The third point to which I should like to refer is the question of insurance. This is not an easy problem to deal with. An attempt to deal with it is made by the Minister in section 9 where it states that:

(1) A person shall not — (b) conduct a clinical trial,

unless there is in force a policy of insurance... sufficient to enable that adequate funds are available to provide appropriate compensation for each participant who may suffer injury or loss as a result of the trial,

Anybody who is injured will get compensation. What is proposed is a "no-fault" insurance. It is appropriate that there should be some insurance cover against negligence and that risk should be capable of being insured. I have some doubts, however, as to whether in certain cases to which I will refer it will be possible to arrange for a system of insurance on a "no-fault" basis. It may be possible that those organisations conducting the trial may be able to underwrite, not through a policy of insurance from their own resources, the no-fault element which the Minister feels is an essential part of the protection which those involved should have. However, the Minister would not be satisfied with the underwriting by the institution, whether a health board, the College of Surgeons, a private clinic or any other institution of that kind to which a medical practitioner belongs. He is not satisfied that they should underwrite any claims which might arise in respect of the trials they conduct but he is insisting on a policy insurance to cover all risks, which might be a bit difficult.

Senator Ulick Burke referred last week to the fact that from time to time treatments are devised of a fairly new or traumatic nature which, because of their uncertain outcome, are first "tested" on people whose prospects of success without that procedure are virtually nil. For that reason, the first people to receive heart transplants were probably those who least benefited from them, people who were at death's door. They were certainly going to die. They were taking very little risk with their life and were being presented with a possibility of life. It is only as expertise is built up in processes like that those at less risk are included in the trials.

It probably applies, for example, in the area of cancer that tests of all kinds which could certainly have medical consequences, are tried at frequent intervals. It is right, if it is necessary to try new forms of chemotherapy, new treatments or to administer new drugs, that they should be tried on people who have the least chance of surviving without them. What prospect would there be for a policy of insurance in those cases? Would it be realistic to get a policy of insurance in respect of somebody who is literally at death's door, suffering from cancer, whose only prospect of survival is a treatment which has not yet been fully and completely tested for the general market? In those cases what would be necessary according to this Bill is a policy of insurance, not merely that the hospital or the doctor concerned would say that, if as a result of this treatment somebody, dies, their relatives will be compensated in an appropriate fashion. That would not be sufficient. It would be necessary for a policy of insurance to be underwritten by an authorised insurer within the meaning of certain specified regulations and that this authorised insurer would guarantee to this person or to his or her relatives that if he or she dies as a result of this treatment then appropriate compensation will be paid on a "no-fault" basis. In such circumstances there would be no negligence attached to the administration of a drug.

In these cases does the Minister really think it is right that because it could not be called anything else, such a trial, should be delayed until such time as a policy of insurance could be effected? I do not think that is reasonable or practicable and section 9 does not meet these problems. All my instincts as a lawyer are against "no-fault" liability because "no-fault" liability, while grand in theory, places less importance on the care of the person carrying out the operation or the action which gives rise to the possibility of damage. I am not satisfied that "no-fault" insurance is in the long term interest of the people but if "no-fault" cover is what is needed the Minister must address the problem of the kind outlined by me where a substance or preparation would be administered partly in order to help the person but also for the purpose of a clinical trial and not necessarily as a result of that trial. If the person dies and nobody can say for certain whether it was as a result of the trial how could a policy of insurance cover such an eventuality?

They are the main points which I should like the Minister to address when he closes the debate on this Stage. There is, however, one small additional matter to which I should like to refer, the extraordinarily long title of the Bill, which is of the most detailed kind and gives rise to concerns. One would expect the long title of the Bill to say something like, "a Bill entitled an Act to provide for clinical trials, etc." or something like that, a short title, but it goes into extraordinary details as follows:

An Act to provide for control over the administration of one or more substances or preparations to persons for the purpose of ascertaining the effects of the administration of such substances or preparations on those persons where such administration may have a medical or harmful effect...

One of the controversies on Committee Stage will be whether the word "medical" should be included. If it is in the long title how will that affect our ability to amend the Bill? Will somebody say that, because the long title is so detailed, to change and omit the word "medical" where it occurs — and it occurs in section 5 (2) of the Bill — goes against the principle of the Bill as passed by the House on Second Stage? That is a matter for concern. The definition of the conduct of a clinical trial included in section 5 (2) should not have been put into the title of the Bill. Instead, the words "clinical trial" should have been put into the long title of the Bill so that the definition could be changed on Committee Stage. It is inappropriate that the long title of the Bill should contain something which is in itself used as a definition within the Bill. That is a technical matter which I bring to the attention of the Chair, because it is important to realise that in supporting the Second Stage of this Bill I am not necessarily supporting the conduct of a clinical trial as defined in section 5(2). Therefore, the inclusion of a substantial portion of that definition within the long title of the Bill should not be taken, certainly in my case, as giving approval to that particular definition of what a clinical trial is.

That having been said, the constructive attitude shown by the Minister in introducing this legislation, the detailed examination which it has received on Second Stage by this House and which it will no doubt receive by this House on Committee and Report Stages, means that by the time it leaves this House and goes to the Dáil it should be a better Bill. I am hopeful that the consideration of the Committee Stage of this Bill can take place in the near future. I would not like the Minister to leave his first term of office next October without having——

An Leas-Chathaoirleach


——in October 1987 without having this Bill enacted in plenty of time so that the system of control of clinical trials which it establishes will be in operation for some time before he reenters on his second term of office.

I always enjoy very much listening to Senator O'Leary in this House but the last part of his contribution puts a question mark over his judgment, at least in relation to that matter. I hope it does not extend to all the points he has covered.

My contribution will be very brief because many of the areas I should like to deal with have already been covered and there is no point in going over the same ground again. Also, it is an area where considerable expertise is required, which I do not have. I recognise that it is an important Bill and I can extend to it the general welcome Senator O'Leary extended to it. I will have to stop short, like other Members on this side of the House, of a full and total welcome.

Senator McDonald commended the Minister on his aptitude in steering his Department in a very determined way. I have no doubt he intended that phrase as a tribute to the Minister. It could also be taken in a pejorative sense. I have no doubt that everybody appreciates the wholehearted characteristics of this Minister. They are evident in the dismantling of the health services, in the denuding the hospitals of facilities and equipment and in the drastic reduction in hospital space.

Does this arise on the Bill?

Perhaps not directly, but as a Senator O'Leary well knows, like Michael O'Hehir who referred to a foot-baller making an angle for himself, when trying to get into the subject I think I am entitled to have a little run before I come to the high jump.

Before a clinical trial?

An Leas-Chathaoirleach

Senator Fitzsimons to continue without interruption.

What I am saying, and what has been said here not in so many words, is that the Minister does not know when to stop in any area. This Bill apparently has been produced without the necessary consultation. Indeed, much consultation would be necessary in this area. The Bill goes too far. It will impede rather than improve the situation in some areas. The point Senator Fallon made was that in many areas the Bill goes too far. Perhaps, in some areas it could go further and representations have been made in this regard. In essential areas the Bill goes too far. Nobody denies that there is a need for the legislation. In the representations that have been made to us by the experts this is clearly acknowledged.

Experimentation, unfortunately, is necessary however distasteful it may be. The great strides made in the area of medicine and preventive medicine have been the result of experimentation. It is an emotive issue. This has been covered very thoroughly by Senator Fallon and by other Members of the House and I will not pursue that line. With regard to the title which has been dealt with in some detail by Senator O'Leary, substances and preparations are specifically covered so that it appears that ministerial approval for normal dietary studies will be essential. This is a mistake. The result will be bureaucracy, delays, frustration and unnecessary interference. Some Members on the other side of the House had reservations about the Bill. I have no doubt that it will be passed on Second Stage but we on this side will have a number of amendments on Committee Stage.

A tribute should be paid to the National Drugs Advisory Board for the work they have done and their unique expertise. Unfortunately, they are not mentioned in the Bill. This is a mistake. Their role should be enchanced in keeping with the important work they have done and are doing rather than denigrated by omission from the Bill. As other Members have said, representations have been made to us in relation to this Bill as, indeed, for most Bills that pass through this House. I would like to refer very briefly to some of the bodies and individuals who have made representations to us. First of all, we had representations from Elan Corporation plc who have an address in Athlone and the following sets out the details about this firm. The information is supplied by Professor Joseph Masterson.

In brief there are 140 people directly employed and 1,200 hotel bed nights annually are catered for by foreign visiting clients. Of course, the Irish airlines are used. In total, the mainly local contribution of this firm amounts to £6 million per annum. That is a very considerable sum. It is interesting to consider what they have to say. The company's economic achievements and considerable international reputation depend critically, they tell us, on timely, efficient and fastidious performance of studies at the company's clinic. Elan state categorically that their guidelines for the conduct of these investigations not only conform to those proposed in the Bill but also fulfil the requirements of the most demanding regulatory authorities worldwide. I would like to quote one paragraph in a letter from the chairman and chief executive officer. It is as follows:

We can not accept without protest, the imposition of a bureaucratic superstructure, with all that this implies for delays and impaired efficiency on an essential scientific function which always operates to the highest standards. Any resulting impairment of Elan's ability to complete successfully in international markets will not merely stifle the continuing growth of the Company, but could force our existing international clients to relocate their custom to a more realistic scientific and economic climate.

Quite simply, we do not require any regulation over and above the expert and highly efficient monitoring service already provided by the National Drugs Advisory Board. The most positive and least expensive contribution the Department of Health could make to safe and efficient conduct of Clinical Trials in Ireland would be to provide the Board with adequate funds to continue and expand this work.

There are many other areas I would like to quote from but I will leave it at that. The Minister might quite rightly say that this firm have a vested interest in this Bill and, of course, they have. I must admit that and, indeed, all those who make representations to us have vested interests. But we also received a very important statement from the Royal College of Physicians of Ireland. This statement is signed by nine professors and the President of the Royal College of Physicians of Ireland. The Minister must take note of what is contained in it, of which I would like to quote three short paragraphs. They are very important.

As representatives of major academic institutions concerned with medical education, medical research and standards in medical practice, we have grave reservations with regard to the content, scope and operation of this proposed Bill which, if enacted, would have a serious determental effect on medical care and research in this country. Contrary to his statement to the Senate on 27th May, the Minister for Health has failed to formally consult the relevant medical bodies with regard to this legislation. We acknowledge that there is a generally accepted view that legislation is required for the control of clinical trials and this must protect subjects participating in research and also be conductive to continued medical progress. The Bill falls seriously short of these objectives.

We are particularly concerned that the scope of this Bill which encompasses not alone new drugs but all established drugs in everyday medical practice, including those that can be brought without a prescription, normal food substances and vitamins. Not alone will Ministerial permission be required (on the payment of a fee) for normal medical and dental students educational practical classes but also for studies involving simple dietary changes.

We are of the opinion that a distinction must be made between drugs in routine clinical practice and new drugs that are not fully recognised for clinical use. In the case of the former a properly constituted ethics committee has both the remit and means of assessing all matters pertaining to such a study. Approval by the Minister for this purpose is expensive both in terms of time and money and will introduce unnecessary bureaucracy. On the other hand, with new drugs it is desirable that the Minister should have a role in vetting the proposals.

There are many other areas in this statement that I would like to quote and indeed I could paraphrase. It would be important to do so, but I will refrain from it as it would be taking up the time of the House. I would simply say that other areas covered relate to the Bill being drafted assuming that all medical research involving drugs is commissioned by or is supported by the Pharmaceutical Society. Obviously, this is not so, as stated by the professors. There is a section on the ethics committee. There is a statement that the Bill in this respect runs counter to the ethos of current hospital and university ethics committees which review research protocols independently of the applicant. There are questions as to whether the Minister should be the final arbiter as to a particular trial taking place and that is developed in some detail. The statement goes on to tell us that this Bill is seriously out of line with legislation in this field in other western countries and may prevent Ireland from participating in much international research, such as that organised by the World Health Organisation. It deals with the forms of insurance demanded. Senator O'Leary has covered. this aspect. The final short paragraph of the letter is as follows:

Our institutions have a major commitment to legitimate and necessary medical research. We are concerned that the Bill, if enacted, will be a serious impediment to medical progress. We urge our legislators to take account of these matters and hope they would consider it appropriate to consult with those who have a legitimate concern for medical research and patient welfare. Such consultation should enhance the Bill so that the objective of protecting participants is achieved but in an environment in which much needed medical research can continue.

We had representations also from the Social Policy Action Group and from the Simon Community. These I can deal with better on Committee Stage and I do not intend to go into them now. The charges made by these very important medical men are ones which must be considered by the Minister. Are they all out of step except the Minister? I accept what Senator O'Leary said, that the Minister when dealing with Bills in this House has always been reasonable. I hope that in this case he will continue that precedent and that he will be reasonable and will accede to the amendments we will seek to have included in the Bill on Committee Stage.

I welcome the Bill and I shall comment very briefly on what Senator Fitzsimons has just said about the charges made by the practitioners and by others. I would regard them as requests rather than charges, requests to make this a better Bill.

The Bill is in accordance with the aims of the Progressive Democrats — to safeguard the rights of the individual and to protect and help the weak and deprived members of society. The Bill provides for a statutory system of controlling clinical trials which involve the testing of individual drugs and other substances to establish whether they may have a harmful medical effect. Under this Bill the Minister for Health has the authority to revoke permission to undertake any of these clinical trials. He has established the ethics committee proposed by him and he and they will have to satisfy themselves that the proposed trial is justified under a number of headings; that the planning and organisation of the trial are right; that the qualifications and competence of the people conducting it are in order; that the criteria for the selection of participants are in order; that the arrangements for medical supervision of the participants are in order and that rewards to individuals taking part in the trials are adequate or in order as well.

I would refer to section 8 of the Bill which provides for the consent to participation in clinical trials. It states that any consent shall not be valid unless the person so consenting is aware of the objectives of the trial and the types of drugs that are to be used. The person must also be aware of the risks and the after-effects of each trial.

The section seeking to provide protection for individuals does nothing to stop a person finishing tests on one set of drugs and immediately starting clinical trials on another set of drugs. It is a known fact that the body contains traces of drugs for some considerable time. If traces of one drug are mixed up with a new drug it could be very deterimental to the individual taking part in the clinical trial. Chemical products taken on their own can be quite harmless but the interaction of two chemicals could be lethal. There should be a provision in the Bill to ensure that a person who has taken a series of clinical tests should be excluded from taking part in any other clinical trial for at least three months to allow the body to settle down and also to make certain that the trace elements of one drug will not be interchanged with another drug, as that could give rise to a very serious situation.

The College of Physicians of Ireland stated that up to May of this year the Minister had not met the body to discuss this legislation. Will the Minister rectify this, because this statement should not be taken lightly. Consultation with this body is vital. They are concerned with the scope of the Bill and say it covers not only new drugs but drugs which can at the moment be purchased without a prescription, and normal food substances and vitamins. They agree that a distinction has to be made between new drugs and routine clinical practice. They agree, that the Minister has a duty and a role in the vetting of new drugs. They think the present legislation will discourage research initiative with drugs in normal use. They also ask the Minister to give grounds on which clinical trials have been refused. This is a reasonable request.

The National Drugs Advisory Board is a well known competent and independent body which has played a major role in drugs in Ireland. They should have played a pivotal role in this legislation but they do not appear to have played the role we would have expected them to play. The Minister should examine this and ensure that the National Drugs Advisory Board have a very important role in the execution of this Bill. The College of Physicians also say that the Bill is out of line with legislation in other western countries in the control of clinical trials and that it may prevent Ireland from participating in much international research, such as research organised by the World Health Organisation. The Minister should examine that major statement to see if what they are saying has any basis, and if it has, we should make sure that the World Health Organisation are not prevented from coming to this country. I ask the Minister to take these views on board.

I welcome the Bill as a major step forward in clinical trials, and I hope, as Senator O'Leary said, that we will be around long enough to see it through the Houses of the Oireachtas.

I too welcome the Bill. Over a period there has been considerable concern about the methods by which clinical trials are carried out here and there have been articles in the press stating that our ways of controlling these trials are much looser than in other countries so that international drug companies use Ireland in a way which may not be desirable. There has also been concern about the way in which human beings are being used as experimental animals in the conduct of clinical trials. I am not suggesting that most of the bodies running these trials are doing anything wrong or undesirable but nevertheless it is important that we should have legislation like this.

I was very pleased that the Minister in his introduction to the Bill on Second Stage stressed the fact that the interested participants in clinical trials were of such great importance, because this is the nub of the matter. If we are asking people to take part in clinical trials we must be very careful to look after their interests. This is especially so, because where people may be tempted to take part in clinical trials because there is a certain financial inducement for so doing, they tend to be the least protected people in society and the least well able to look after themselves. It is essential that our legislation and any regulations made under it should look after such people and ensure that they are not being exploited and that they are not offering themselves wrongly for clinical trials simply because they need the money and because they are offered financial inducements for doing so.

There is a difference— and this has been stressed in a number of the submissions which we have received from various bodies which other Senators have referred to—between the kind of clinical trial that is carried out on otherwise healthy participants who are simply volunteers who come in off the street to be guinea pigs for clinical trials, and the kind of clinical trials that may be carried out in hospitals, not necessarily financed by drug companies, but carried out as part of medical research in hospitals and other medical institutions. Many of these may be trials which are carried out with the participation of patients, people who are suffering from a disease and who are made aware of the possibility that a new drug or a fairly new drug may be of help to them. This is a rather different situation and not one where you are likely to get people being brought in as people on whom clinical trials can be carried out.

I will comment briefly on parts of the Bill which can be raised again on Committee Stage. Section 2 of the Bill suggests that where a clinical trial is proposed to be carried out there are various matters which should be made clear when applying for permission to do so. This is an excellent section. Obviously this is something which should be done. Perhaps it is important that, among these various things which should be suggested, details of the method of recruitment of volunteers should be given. This is much more applicable in the case of the first stage trials of a drug on otherwise healthy persons. Perhaps, as well as the criteria to be used for the selection of participants, we might also include the way in which participants are to be recruited. There have been allegations that participants are being recruited by financial inducement out of homeless persons' hostels and various places like that. This is not a very desirable method of recruitment. When a body are applying to the Minister he should know how and where they are going about looking for the participants in their clinical trial. I am sure the Minister would agree with me that it is desirable that this should be controlled. I know this is the kind of thing the Minister is aiming at in the Bill but I feel it might be mentioned specifically.

There is the question as to whether there should be any monetary inducement or reward for taking part in clinical trials involving otherwise healthy participants. This is rather a difficult question because one can say that, for instance, in this country we do not offer any financial inducement or reward for giving blood to the Blood Transfusion Service Board. This seems to be a much better way of doing it rather than, as in some other countries, where people are paid for giving their blood. This tends to give rise to people giving blood because they need the money. For that reason they may conceal from the Blood Transfusion Service Board certain vital information such as whether they have ever suffered from infectious hepatitis or something of that sort which would make their blood unsafe.

On the question of clinical trials, it might be ethically and ideally much better if volunteers were pure volunteers and were not offered any kind of financial inducement or reward, even though it is often described as being for expenses rather than an actual payment. Whether you call it expensess or payment it is a financial inducement. However, on a practical level, I am inclined to think that one might be very short of participants in these trials if one made a very hard and fast rule of this sort. Obviously there are no ill effects in giving a pint of blood. The Blood Transfusions Service Board are most meticulous in ensuring that they do not take blood from anyone who is likely to suffer ill effects thereby. One would be more doubtful about offering oneself for the trial of a drug. We may not be able to get away from the situation where some sort of financial inducement is offered, but it needs to be very carefully controlled. I hope that the framework of this Bill will enable it to be carefully controlled. I also hope the Minister and any further Ministers who are administering this legislation will be extremely careful in dealing with applications made to them under section 2 of the Bill.

One of the other matters one might mention is the type of consent given under section 8 of the Bill which is the consent of the person who is going to take part in the clinical trial. The wording of the Bill is very helpful in insisting that the person consenting must be capable of comprehending the nature, significance and scope of his consent. This will be of great assistance. I understand that in the past people have been offered consent forms to sign which an ordinary lay person going into a clinical trial would not necessarily understand. They would not necessarily know the scope of the consent they were giving. In addition, as many of the people who are taking part in these trials are perhaps less well educated persons, it is essential that it be made quite clear to them what kind of consent they are giving.

If I might make a parallel, over the years in the field of adoption law considerable complications arose both in statutory provisions and in court decisions about the nature of the consent given by a natural mother for the placing of her child for adoption. It is a much more difficult question than one might think. It is surprisingly hard to draft a form which is really comprehensible and which gets across exactly what you are consenting to. I recall, as a member of the Adoption Board, when we were actually drafting this sort of form. I am conscious of the difficulty in drafting it. Therefore, I ask the Minister to take particular notice of how these consents are to be drafted, what scope they have, how comprehensible they are and also control of the sort of person who is administering the form. If you have a consent form administered by people who are keen on getting persons to consent, they may go a little far in pushing them and in interpreting the form in a way favourable to them. I would like to see the form administered by someone of a fairly neutral character, perhaps someone who is involved with the ethics committee rather than the person who is actually keen to get the trial off the ground.

There is also the possibility that one should build into a consent form a period of pause between the actual signing of consent and the beginning of the trial in order to allow the person a little time to change his mind. Even in a hire purchase agreement this kind of pause is allowed. A period is allowable for somebody to change his mind and say he does not want to enter into the agreement. In the case of something so vital as giving oneself for a medical experiment it would be no harm to have a statutory period of a few days in which the person could think about it and decide whether he really wants to continue with this consent or change his mind.

All of the bodies who have made submissions to us mentioned the ethics committees. In particular, the people from the Royal College of Physicians, the Federated Voluntary Hospitals and the medical department of Trinity College would agree with the people on the other side such as Simon and the Committed Social Policy Action Group that it is very important that the ethics committee should not just be nominated by the people who are applying to carry out the trial. The ethics committee should be a stable body, not just appointed for this particular trial, but a body accumulating experience and consisting of people who are getting to know the field. It would, presumably, contain medical personnel who would have the expertise to understand and explain the kind of trial being carried out. It is also very important that it should contain lay personnel who would have a general, ordinary citizen's view of the matter. If one is to have a different committee appointed for each clinical trial these people will not have the opportunity to develop expertise and to learn. As anybody who has served on any sort of committee will know, one learns as one goes along and one discovers a great deal of the background to these trials as one accumulates experience.

Therefore, I think the suggestion made by the federated hospitals and other bodies that there should be a more permanent ethics committee, as there is now in the hospital system with regard to trials, is a good suggestion. The Minister should consider this. I do not consider it a good idea that ethics committees be even nominated by the people who are going to carry out the test. I would prefer that these committees be either nominated by the Minister or by somebody who would be expert in the field, perhaps the National Drugs Advisory Board or one of these bodies that would be neutral in the field as it were. Again this is a matter which we could deal with in more detail on Committee Stage but it is an important one and one that the Minister should perhaps reconsider.

Other Senators have mentioned the matter of insurance as it affects the second kind of trials, the trials that require the participation of people who are already patients and who are already taking other forms of drugs. It has been suggested that there may very well be considerable difficulty in being able to get insurance to cover, say, a person who is suffering from a very severe form of cancer. This is a practical point which should be looked at again. I do not want to go into it at any length because it has been mentioned by other Senators. Obviously the insurance cover part is of extreme importance so far as the phase I trials are concerned where the otherwise healthy people volunteer to take part in clinical trials. I welcome this provision in the Bill in general terms but it may give rise to difficulties in the other sort of clinical trials which take place in hospitals as opposed to the trials of drugs which are financed by the pharmaceutical industry.

There are the points, too, which other Senators have mentioned, for instance, that perhaps the definitions cover too wide an area so that the Bill would cover even established drugs which are freely available without prescription and dietary substances and various matters of this kind. For instance, if one was trying different diets for diabetics or something of that sort, this might not necessarily be the sort of clinical trial that the Minister wants to deal with in the Bill. A further look could be taken at this particular area.

There are a number of other smaller points which I think would best fall to be dealt with on Committee Stage. I would finish by saying that I welcome the introduction of the Bill and the Minister's attitude and his wish to bring in this kind of legislation. I feel sure that he will go along with Senators in having another look at some of the sections on Committee Stage and perhaps bring back amendments on Report Stage which would improve the Bill while it is going through this House. It would be one of the best purposes of introducing this Bill in this House that we should be able to amend it in such a way that it will go to the other House as the most perfect possible Bill. That will perhaps hasten its passage into law and make sure that these essential controls are introduced as soon as possible.

I wish to thank the Members of the House for their very comprehensive and thoughtful consideration of this Bill. They gave a fairly thorough airing of the different points of view which are held in relation to the conduct of clinical trials. I have taken very careful note of all of the contributions. When they have been considered fully in the few weeks ahead — before Committee Stage, I hope — I will come back to the House on Committee Stage with my detailed response to them. That will include, I can assure Senators, a number of amendments to the Bill.

I was reluctant to have individual discussions with individual Senators outside of the ordinary process of the House because in relation to this Bill I have received a very large number of representations from a very large number of interests who are directly involved both in the monetary and manufacturing side of trials. Many of the representations, both from the professional and industrial sides, received by Senators have been in that framework. In that sense I was reluctant, coming into the general principles of the Bill, to engage in individual consultations. Certainly during the course of the preparation of Committee Stage I would be free to talk to Senators from all sides of the House on particular sections and the work of the Department will continue intensively in that area.

It is imperative that we have a degree of unanimity in the House about the Second Stage of the Bill. I would be very surprised if the Fianna Fáil Senators or any of the Independent Senators opposed the Second Stage of the Bill at this stage because it is absolutely in the public interest that there be a particular statutory framework for the conduct of clinical trials. I have no doubt whatever in that regard. There is not a great deal to go on by way of European or American legislative experience. A great deal of what happens is, to an extent, shrouded in a veil of professional research. Of course the one thing which I have learned in my own tenure of office is that whenever anybody dares, presumes or attempts to in any way intervene or interfere in the area of professional research the hackles are up and the reaction tends to be massive. For example, to take section 2 of the Bill which has caused concern to a Member of the House, the proposer would be obliged to send to the Minister of the day the names and respective qualifications of the persons proposed as members of ethics committees for clinical trials. The Minister would have to give approval. It has been suggested by Members of the House that I should have a national panel for an ethics committee. Imagine what would be said if I had enshrined that in the Bill. Imagine the uproar about departmental interference, the uproar of professionals who would say that not in any circumstances would they participate in any clinical trial with this draconian all-embracing Minister of the day seeking to destroy their professional independence. This is part of the problem. This is why I very much resisted that particular concept of a central ethics committee nominated by the Department or indeed controlled by the Department. I wish to see a degree of flexibility in it even though it is true to say that the proposer as such has a considerable degree of latitude in bringing forward the names and qualifications of the members of the ethics committee. That is a major aspect of the Bill which I am prepared to discuss at considerable length with any Senator or any of the bodies concerned who wish to make further representations. I am very hopeful that the House will reach a general consensus for a framework. That is important.

I sought in my introductory speech to point out strongly that the aim of the Bill was to provide for a legal system of control of trials which would ensure protection of participants, at the same time providing scope for the necessary fundamental research which is so important before drugs may be licensed for general use. It is not my intention or that of the Department of Health to impose unnecessary restrictions or to interfere with the arrangements for the supervision of the trials which already represent adequate protection for all of those involved. It is not our intention to simply run a superstructural bureaucracy in the area. For example, Senator Robb made a rather thoughtful point in his customary balanced contribution. He brought out the point that legislation in this area among other things could help to temper the zeal of ambitious young doctors, for example, trying out new drugs. I quote Senator Robb deliberately because the only hope one has in this argument is to quote a member of the profession back to the profession and hope that one will not be clobbered in the process. Senator Robb gave a graphic description of holding up the cheque, of how he had been sought to volunteer, so to speak, to undertake that role.

I am glad to note that there seems to be unanimity about the general role of the National Drugs Advisory Board. The main reason I did not put the NDAB into the Bill as drafted earlier was that I thought it self-evident. For example, when making regulations relating to licensing of human medicine we do not mention in those regulations the NDAB because the board do this self-evident work, but if the House feels very strongly about this matter on Committee Stage or in our consultations and if it wishes to have a particular reference to the NDAB in a positive way, I will consider this matter and I will discuss with Members of the House how best that could be encompassed. However, it was never the intention that we should set up a major bureaucracy inside the Department of Health or that we should in any way diminish the role of the NDAB but I would stress that they are an advisory board. They only advise the Minister of the day, and as such we have had considerable difficulty in the drafting of this Bill in having devolved on the board greater statutory powers than they have under their existing establishment order.

Therefore we would have had to go down a totally different and very difficult road if we had to devolve statutory authority on what is in fact an advisory board, advisory to the Minister. In that framework we were reluctant to put it in, but I assure all parliamentary colleagues here that I will look very carefully now at the incorporation into the Bill of a reference to the NDAB subject to the views of the parliamentary draftsman who was of the view that the advisory board as a matter of general principle is not enshrined in the Bill.

I would like to confirm for Senator Robinson, Senator Ross and the other Senators who raised it that it is not intended that there be an ad hoc ethics committee for each trial. For example, a hospital which regularly carried out trials would be able to refer to the fact that its standing committee was the ethics committee for each trial applied for. As we know, it is in relation to hospital facilities that a considerable amount of the work is done. That is not always necessarily known to that extent at public level that it is done, but it is done. These hospitals have standing ethics committees, and the assurance I would seek from the facility or the hospital is that they be constituted on an impartial basis in accordance with guidelines recommended by the NDAB and, lest there be any difficulty in the Bill, I would be quite prepared to incorporate again a clarifying amendment which I hope will meet the reasoned observations made by Senators in that regard.

I dealt with the question of section 7 (5) and the objections raised where applicants effectively are given, as alleged by Senators, a deployed authority to alter an ethics committee. Again, there must be flexibility here. One can set up an ethics committee and a member of an ethics committee can die. A clinical trial is a very expensive and time-consuming exercise, and the people who would run to me and demand that there should be a section in the Bill to enable the membership of an ethics committee to be changed would be the very professionals who would find themselves in dire straits if legislation was not enacted which provided an ongoing basis for a situation in the middle of or towards the end of a trial where a member of an ethical committee had emigrated. Quite a number of them go around for professional work to different hospitals and institutes; they travel around a great deal, particularly at the beginning of their careers and very often at the end of their careers they go into more academic streams. Therefore, we must have flexibility. I will consider that when the Bill is reviewed on Committee Stage.

I want to say, though, that many of the representations I have received were what I would call reaction representations. One problem in this area which was very evident in legislation passing through the House here, on the Nurses Bill, the Dentists Bill, this Bill and much other legislation is that, perhaps for the first time in two or three decades, we are enacting legislation in relation to social policy particularly in the health area, and most professions have no experience of it at all. Very often the worst possible motives are attributed in line by line when one has to say that it is in there because of a contingency which could arise in the lifetime of legislation. Very often the parliamentary draftsman is very rigorous, correctly so, in ensuring that the legislation be so framed, but Senators know that in the House I have been entirely flexible and open to change and in that regard I assure the Senators that I will be taking a further very vigorous look at the Bill itself.

Senator FitzGerald was very — I will not use the word "scathing"— concerned about what he regarded as an undue development of centralism in the Department of Health and that that is reflected in the ethos behind this Bill. I assure him that the real problem in this Department is that until quite recently there has been no centralism whatever. We have so devolved everything now to the agencies that the system was practically out of control when I became Minister for Health. Are we suggesting seriously, particularly since the Senator referred to the fact that he was associated with a number of voluntary hospitals, that, where one is dealing with public funds which to date total in terms of the Dublin voluntary hospitals alone a budget figure of £270 million in taxpayers' hard cash, where 15,500 people are employed in the 30 hospitals involved, the Department of Health should, without question, without monitoring, without any policy guidelines, hand over each week large sums of public money, and tell those hospitals to do what they will, to specialise in what they will, to develop what they will——

I was not suggesting that.

——and that we will stand back as a Department? We cannot do it. That has been the ethos——

Nobody would want that extreme measure.

It is not possible in a small country.

Nobody wants that.

We have been spending £270 million in those hospitals and we are far from dismantling the system, as the Senator suggested earlier. When I came into office the figure was around £200 million, and it is rising well above the rate of inflation. There has been a reduction of about 3 per cent but in the past six months the saving in the price of oil could nearly get rid of that reduction.

There is no bureaucratic Civil Service centralist grasping as was suggested by one Senator. There is no suggestion that that is the general culture prevailing for the introduction of this Bill. Senator Lanigan in particular mentioned the secretary's name but there is no question whatsoever that the Secretary of the Department of Health, either in relation to this Bill or to any other aspect of health policy, will do his own thing, or run the Department of Health without reference to the Minister for Health. As a matter of public policy, I encourage officers in my Department, be they medical, administrative or professional, to go up front and declare themselves, but when they so do, their statements are cleared by the Minister of the day. That, I think, is desirable and absolutely necessary. Some public servants and some politicians find this extraordinary but I do not, because I believe in open Government, and in an open Civil Service and public service. I see nothing wrong with secretaries of Departments explaining to committees of the House, or to joint committees of the House, reasons for policy formation evolving in a particular way. Three Senators have made inferences in that regard. Senator McGlinchey made a particular reference at the annual conference of the Association of Health Boards in a perjorative way. I must rise in defence of the public servants in that regard.

He is no longer a Senator.

I will leave it like that because I think it would be entirely inappropriate to develop it further. It would be like the phrase of the Bill, "as soon as is practicable" and I will be looking at that phrase as well.

Reference has been made to the insurance provision proposed. I can see the point made by Senator O'Leary regarding the unfortunate person who may be suffering from terminal cancer who is offered the prospect of speculative therapy or surgery. My reaction is that this is essentially a matter of medical practice, essentially a matter of clinical practice, and not related to clinical trial as such. One can distinguish, and ethics committees can sharply distinguish, between the involvement of such persons in trials and final hopes relating to particular aspects of a particular illness and to what one might call, for want of a better phrase, conventional clinical trials. That distinction can be made, and is made, every day in medical work. I have no doubt that it will not undermine the essential purposes of the Bill. I hold the view that we must have an insurance cover in that regard. I will examine the difficulties mentioned in relation to the section, and see if it can be amended in a way which will not interfere with the intention behind the section, which is to ensure that there will be adequate compensation for participants who may have been harmed by a trial. We are dealing with a multi-million pound industry, a very wealthy industry, which so far as I am concerned, can well afford to indemnify any particular risks suffered by individuals.

That will not be allowed by the Bill. They must have a policy of insurance.

It must be submitted to you, Minister——

The Minister without interruption, please.

I will come to that on Committee Stage. It is essential that this matter be considered. Some of the initial reactions to the Bill, for instance, that I was to become involved in the control of dietary studies and demonstrations are unreal. I would like to allay any fears in that regard and if necessary, I will introduce amendments. I confirm that these matters will not be contained in the Bill.

There is a lot of work to be done on this Bill. I had the difficulty of having to say to the Government that we in the Republic of Ireland were engaged in a rather unique exercise as regards this legislation. There is no question of withdrawing the Bill at this stage. Senator Robinson made the point that it should not be withdrawn and substituted by a new draft. I will go through each line of the Bill, including the Heads of the Bill and the Long Title, and take on board the points made here. I will consult with the interests concerned. In this country consultation is frequently regarded as an opportunity to obfuscate, or to send back to the Department or to professional groups and so on.

One way to get legislation like this through the Oireachtas is to introduce it in the Seanad. I want to thank Senators Dooge and Ferris for their co-operation in having the Bill initiated in this House. In a few weeks we will sit down and go through it line by line. I will be accommodating and if any members of the professional organisations directly involved have any further representatives to make on it, I urge that they be sent in now as a matter of urgency. So far as I am concerned this debate has taken place in public. I have not visited any institutions of clinical research as a matter of public policy. I have tried to stand back, but I will meet some of the commercial interests directly involved. This legislation must be given priority.

I want to thank Senators for their very constructive contributions. We will deal with this Bill line by line. I have no doubt that this will be exceptionally beneficial legislation, which will be precise and without ambiguity. In the 1963 Planning Act, the 1976 Act and so on, I recall the manner in which office holders got themselves into enormous difficulty in relation to physical planning matters. In relation to this issue we have learned a great deal. We can learn from lessons of the past and bring in a Bill that will meet the wishes of the House while, at the same time, reflecting public interest in legislation of this kind.

Question put.
The Seanad divided: Tá, 26; Níl, 18.

  • Belton, Luke.
  • Browne, John.
  • Burke, Ulick.
  • Cregan, Denis (Dino).
  • Fleming, Brian.
  • Higgins, Jim.
  • Higgins, Michael D.
  • Hourigan, Richard V.
  • Howlin, Brendan.
  • Kelleher, Peter.
  • Lennon, Joseph.
  • McDonald, Charlie.
  • Deenihan, Jimmy.
  • Dooge, James C.I.
  • Durcan, Patrick.
  • FitzGerald, Alexis J.G.
  • McMahon, Larry.
  • Magner, Pat.
  • O'Brien, Andy.
  • O'Leary, Seán.
  • O'Mahony, Flor.
  • Quealy, Michael A.
  • Robb, John D.A.
  • Ryan, Brendan.


  • Cassidy, Donie.
  • Conway, Timmy.
  • de Brún, Séamus.
  • Fallon, Seán.
  • Fitzsimons, Jack.
  • Hanafin, Des.
  • Hillery, Brian.
  • Honan, Tras.
  • Hussey, Thomas.
  • Kiely, Rory.
  • Lanigan, Mick.
  • Lynch, Michael.
  • Mullooly, Brian.
  • O'Toole, Martin J.
  • Ross, Shane P.N.
  • Ryan, Eoin.
  • Ryan, William.
  • Smith, Michael.
Tellers: Tá: Senators Belton and Howlin; Níl: Senators W. Ryan and de Brún.
Question declared carried.

When is it proposed to take Committee Stage?

The Minister undertook in his concluding speech to consult with Senators who wished to make representations to him and, accordingly, rather than the customary two weeks I would propose that we allow three weeks and order the Bill for Wednesday, 29 October as the earliest date on which Committee Stage will be taken.

Committee Stage ordered for Wednesday, 29 October 1986.