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Seanad Éireann debate -
Wednesday, 20 Jun 1990

Vol. 125 No. 10

Control of Clinical Trials and Drugs Bill, 1990: Second Stage.

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

The purpose of this Bill is twofold. First, it is to amend the Control of Clinical Trials Act, 1987, so as to deal with difficulties which have arisen in the operation of that Act particularly in so far as it relates to the responsibilities imposed on ethics committees by the Act. Secondly, the Bill seeks to provide certain legal immunities for the National Drugs Advisory Board in relation to the functions imposed on it under Article 4 of the National Drugs Advisory Board (Establishment) Order, 1966.

Has the Minister got copies of his speech?

Yes. The Bill is necessary in order to overcome obstacles which have adversely affected the effective operation of the 1987 Act as a whole and which threatens to seriously limit clinical research in this country. Because of the difficulties being experienced, I established a small working party to review the workings of the Act and in particular how the obstacles might best be overcome. The working group was representative of the pharmaceutical industry, clinicians and officials of my Department. The recommendations of the working group have been taken fully into account in the preparation of the Bill now before the House.

Particular difficulties have arisen for ethics committees from the obligations imposed on them by section 10 of the Act which obliges the committees to satisfy themselves in relation to the adequacy of the financial arrangements made to compensate those who may suffer injury or loss as a result of participating in a clinical trial. Legal advice obtained by a number of hospital-based ethics committees have highlighted the potential open-endedness of section 10 and suggests that the burden placed on ethics committee members in assessing the adequacy of compensation arrangements leaves such members open to being sued for negligence. Most hospital-based committees have accordingly either stepped down or are only giving consideration to trials on products which have licences and which are in current use. Trials on new products have virtually ceased in such hospitals.

I am, therefore, proposing the removal of this particular obligation from ethics committees by amending section 10 of the Act as provided for in section 3 of the Bill. The amendment will require that a person shall not either arrange for the conducting of a clinical trial nor conduct a clinical trial unless they have first established to the satisfaction of the Minister for Health the adequacy of the arrangements for security to compensate persons who may suffer injury or loss as a result of their participation in a clinical trial. The amendment while removing the difficulties experienced by ethics committees, will at the same time ensure that there will be adequate security to provide any compensation to participants that may become necessary.

While dealing with the particular problems of ethics committees I have taken the opportunity to further amend the Act to deal with two other minor matters which require further definition or clarification.

Section 6 (2) (a) (ii) provides for an exemption from the definition of a clinical trial and thereby from the controls set out in the Act of a trial where the principal purpose is the welfare of the patient. In the light of the operation of this subsection, it has transpired that, as worded, there is scope for a fairly broad interpretation of what is intended. Clinicians involved in clinical research sought clarification on the intention of the section and so I proposed in section 2 of the new Bill to amend section 6 of the Act so as to state clearly the aim of the section and specifically to exclude trials where the intention is to prevent disease in, or to save the life, to restore the health, alleviate the condition or to relieve the suffering of the patient. The amendment, which will set out clearly and unambiguously the intention of section 6, was prepared in full consultation with parties involved in this area of research. It will also provide a useful tie-in and ensure consistency with the provision of section 9 (7) of the Act which provides safeguards for patients who are participants in clinical trials.

I also propose by section 4 of the Bill to amend section 13 of the Act which deals with offences and provides for defences in relation thereto. There is a need to provide appropriate defences for unincorporated bodies such as ethics committees and the purpose of the proposed amendment is to bring this about.

It is necessary to provide certain legal immunities for those parties involved in administering the Act, in particular the ethics committees, in relation to their functions under the act. I am also proposing an immunity for the Minister for Health in relation to the Act and am taking the opportunity to deal with the liability of the National Drugs Advisory Board, under this Act and in relation to its functions under Article 4 of the National Drugs Advisory Board (Establishment) Order, 1966 and for committees established under Article 18 of the same Order.

The provision of such immunity is a well established feature of legislation and there are many precedents for it. The members of the National Drugs Advisory Board, who are appointed by the Minister for Health, are leading specialists in the fields of medicines, pharmacology, toxicology and other related disciplines and provide their services free of charge.

Over the years concern has been expressed by members of the board with regard to possible legal liabilities which may fall upon them as a consequence of their membership of the board and they have sought an appropriate indemnity. The matter was referred to the Attorney General for advice. The Attorney recommended the provision of an immunity as set out in section 5 of the Bill. Similar immunity has been granted to other State boards, including EOLAS (formerly the Institute of Industrial Research and Standards) and the National Health and Safety Authority.

In order to ensure the continued participation of specialists to the highest standing as members of the board and its specialist committees and thereby maintain its internationally recognised status, the Government consider that it will be necessary to provide an immunity along the lines which I now propose. The Attorney General considers the proposed Bill to be an appropriate vehicle in which to provide the immunity.

The Control of Clinical Trials Act, 1987 was a prototype piece of technical and complex legislation. In such circumstances initial teething problems were always a possibility. At the same time, the Government were committed to keeping the operation of the Act under review and to deal with any difficulties that might arise. The amendments now proposed will overcome the difficulties being experienced and thus restore Ireland's position as a favourable location for clinical research thereby ensuring the objectives of the Act, to facilitate research and to protect participants in clinical trials, are fully realised.

I do not want to push the point but we still have not got copies of the Minister's script. It is quite difficult to follow a speech like that if we do not have copies.

I understand that arrangements are being made to circulate them and I appreciate the point you are making.

At the outset I wish to express my personal satisfaction and that of my party that this country was, as is reported in one of the national papers this morning, the first in the world to authorise the use of a new anti-viral drug for the treatment of patients in the early stages of AIDS. I gather the name of the drug is Ribavirin and has been approved by the National Drugs Advisory Board and announced by Dr. Allen Scott in the papers this morning. That is particularly good news for the country. It is an interesting development as a back drop to the debate we are going to have today. I welcome that as a major development. It is great this country is at the forefront of this work. People suffering from AIDS obviously cannot wait and is a great advance.

The business of clinical trials and of continuous research into new drugs, their uses and the reaction of patients is very important. As a background to this there was the tragic death of Niall Rushe in 1984 and the dreadful events surrounding the Thalidomide cases. When we consider the tremendous, almost holocaust, proportions of the recent AIDS epidemic in the world, the variety of cancers in the western world, there can be no rational person who does not accept that there is a need to continue the process of clinical trials, to test new drugs on an ongoing basis and to reassess those drugs while in operation.

There can be no doubt that the past hundred years have seen startling developments in international health care and tremendous revolutionary developments in drugs and in the treatment of sick persons. That process must continue. Because we were waiting on this legislation there is no doubt the process of clinical testing of drugs was held up. I have been made aware over the past few days that individual members of ethics committees were concerned about their position and were consequently very reluctant to continue with trials in an unclear environment.

My party are conscious of the fact that this Bill was announced at very short notice. Normally that would concern us but in the light of the legislation in question and of the gravity of the matter we do not propose to make an issue of this but over these couple of days we are having consultations with the different interest groups concerned and we are having ongoing consultations with them and any amendments our party may table in the Dáil will be based on those consultations. We are also happily aware that there have been consultations at Departmental level with the interest groups as well.

On balance, I believe this is welcome and important legislation and it is proper that it should come before the House and be dealt with the greatest urgency. It is the view of my party that it be enacted with the greatest urgency because the matters concerned are of tremendous gravity in terms of bringing about cures in the short term that are necessary and improving the availability of drugs.

While it is important to go ahead with research and not to completely tie the hands of pharmaceutical companies and institutions engaged in clinical trials, it is also important to ensure that relevant safeguards for the individuals concerned are provided. It is very important that at the outset we have a very strict set of criteria for selection of participants in clinical trials. There are risks involved; there are risks of socially deprived people, of people who are in great personal need, of people of questionable emotional health etc. becoming unwitting guinea pigs in clinical trials. That is why it is so important that there be very strict criteria applied to the selection of the individuals for the trials.

It is extremely critical that the person involved be assessed and screened by professional people to ensure that they are there for the right reasons and also that they have a full knowledge of what to expect and of the implications of the trials. It is important that their entire state of health, and I submit their mental and physical health, be assessed at the outset and be properly monitored. Then, it is important that the trials continue in optimum conditions in that the right environment is created for the person who is the subject of the trials. It is important obviously that their health be very closely monitored and also be properly monitored at the end of the trials. It is very important to ensure that there is not an over-utilisation of volunteers, that the same people are not being wheeled in and out of trials on a regular basis.

The question of the ethics committees raises very important points as well and on Committee Stage we will be seeking some clarification about the ethics committees and their role and the role of individuals there. I believe it is important that our ethics committees are made up of medical people, paramedics and lay persons. Those committees have a key role in determining the functioning and the role of the trials. I am somewhat impressed by the view that we should have a national ethics committee, that we should have some sort of a national supervisory body apart from the local ethics committee dealing with specific trials and specific locations. There might be merit in considering having a national body that would look at the situation in an overall sense and perhaps monitor individual centres of trials. That is something that would be worth exploring on committee Stage.

The critical thing is to ensure that proper research continues unabated because all civilised, thinking people would want that and to balance that consideration with the rights and welfare of the individual who is the subject of the trials. It is the view of my party that the legislation is welcome, timely, urgent and important and for that reason we do not propose in any sense to obstruct its passage through the House. I propose to rest the issue at that and to return to more of the minor details on Committee Stage later.

Mr. Farrell

I welcome the Bill and I welcome the Minister to the House. I would like to pay tribute to him for bringing this very important legislation to the Seanad. We all recognise the importance of clinical trials both for medical research and for training in Ireland. It is important that our research in Ireland is on a par with anywhere else in the world, and much better than in some places. That is very important for us as a country and also for the training of people here to do this work. We have a very good, sound university education system and many highly qualified young people coming out of our universities. It is right that we should have a place where they can train, further their knowledge and provide a service that is necessary for the benefit and health of our people and indeed of the pharmaceutical industry here.

The pharmaceutical industry is very big business and employs many people. It is important that we should be able to provide services for it. It is also important that Ireland is seen internationally as a favourable location for this kind of research. We have as good a health service as anywhere in the world and it is important that we have the proper research facilities to make the service available and to ensure that we have proper research carried out on various new drugs that may come on the market.

The original legislation had a twofold purpose — to facilitate research and to project participants. To facilitate research is very important but it is more important to protect the participants. As the Minister said, the amendment requires that a person shall not arrange for the conducting of a clinical trial unless they have first established to the satisfaction of the Minister for Health the adequacy of the arrangements to compensate persons who may suffer injury or loss as a result of their participation in the clinical trial. The amending Bill, while removing the difficulties experienced by ethics committees, is at the same time ensuring there will be adequate security to provide any compensation to participants that may become necessary. That is very important from the point of view of those who will be participating.

It was a new area and problems inevitably arose. The principal problem arose for the ethics committees, and the hospital ethics committees in particular. Some of those committees felt that not alone could they be sued as a committee but indeed that they could be sued individually and it left them in a very vulnerable situation. I am glad the Minister has seen to that and that the ethics committee will no longer be liable.

I would like to congratulate the Minister who was quick to identify the problem and set up a working group to examine how these problems could be resolved. He did not do it lightly. He appointed a working group of very important people in the medical, pharmaceutical and therapeutical fields: Mr. Enright, Chairman and Assistant Secretary of the Department of Health; Dr. C. Barry, President of the RCPI; Professor K. O'Malley, Professor of Pharmacology, the RCSI and Chairman of the NDAB; Professor J. Feehily, Department of Pharmacology and Therapeutics, Trinity College, Dublin; Mr. N. Buckley, Director General, Federation of Irish Chemical Industries; Mr. Kieran Hickey, CAO, Eastern Health Board; Dr. V. O'Gorman, CEO, the Health Research Board and Mr. M. Lyons, Principal Officer, the Public Health Division, Department of Health.

The working group are very eminent people and they had consultants assisting them from the National Drugs Advisory Board, from some of the chemical industries, from the hospitals, from legal people, etc. The Minister did a very efficient job in appointing an excellent board and there is no doubt that the legislation before us has been throughly researched and examined. As a result of the working group's report the Minister brought forward the revised Bill which is before us today. The Bill is to remove the problems experienced by the ethics committees and it ties up a number of other minor matters which required further clarification.

I am very glad to see that section 2 of this Bill has a special provision to exempt the administration of medicines where the patient requires them urgently. Where you might have sombody who was terminally ill, we could fly in a drug from another country and it could be administered in the hope of saving a life. It is very important that we think first of the patient and how best the patient can be cared for.

I am delighted with this legislation. It has been well researched. The people on the working committee were all experts in their fields. I am glad the Opposition have said they will not in any way delay the Bill because it is important that it becomes law quickly. I welcome it and I commend it to the House.

I would like, very briefly to welcome this legislation. It is part of the ongoing process which originated with the original Control of Clinical Trials Bill, which I do not think was introduced by this Minister in 1986-87. In fact, it was so loaded against the medical profession that having been introduced in this House it was then amended in many places in order to make it more practical and as a result of much lobbying from the medical profession at that time.

This Bill is very welcome in that it is an immediate response to difficulties, or almost an immediate response to difficulties. It is very welcome also in that it is a sensitive response to difficulties being encountered in the medical profession and among people on the ethics committees and elsewhere through accepting responsibilities as a result of the previous measure. It is a very difficult Bill because the Minister has to balance the need for practical medical research in this country with protection of those who are submitting themselves to this process, which is indeed something of an ordeal for them. While I welcome the two elements in this Bill, namely the immunity for the National Drugs Advisory Board and the fact that ethics committees will not be personally responsible for compensation — these are fairly sensible provisions to facilitate medical research; the obstruction to medical research was becoming intolerable as a result of what was happening in ethics committees resigning — I think we should also bear in mind the position of those who are submitting themselves to clinical trials of this sort.

Before the last Bill which was introduced in more controversial circumstances because of the death of Niall Rushe, I went down to the Institute of Clinical Pharmacology, I asked if I could go down and see what was happening, who the people were who were submitting themselves to these tests because there was a lot of public controversy and unease, quite rightly, about what had happened. I met many who were submitting themselves to these experiments and it was not a particularly pleasant feeling to talk to them and to realise they were definitely doing it for money. People were not submitting themselves to this sort of experiment unless they needed the money. You did not get people in the professions or in solid permanent jobs going down there. I cannot remember how much money it was then but it may have been £25 a day, perhaps more. You did not get people undergoing the tests for purely idealistic, altruistic reasons, I suppose, it would be a bit naive to expect people to do that. The fact of the matter is that those who submit their bodies for these tests and trials do it because they need the small amount of money involved. That is something we have to confront head-on and decide whether we accept that sort of thing in our society, whether people because they are poor or poorer than others should have to submit themselves to this experience which, by any standards, is a dangerous one.

I am not a medical person but I asked a lot of questions about the sort of tests people went through beforehand. It seemed to me they were very stringent, that the ICP were extraordinarily careful and were leaving absolutely no loopholes where they could be accused of putting people through these tests who were not fit to undergo them. They went to a great deal of trouble and probably on that particular score they were doing as much as could possibly be done at that time. I left satisfied that these people were not being subjected to some sort of draconian procedures as we are sometimes led to believe. Although satisfied that that was the case, I left with an uncomfortable feeling that really it was morally wrong that those people, who submitted themselves to these tests were only from one section of society.

The following suggestion is not something that is necessarily practised in other countries but because we have this difficulty of where the guinea pigs should come from would the Minister consider that everybody should submit themselves to this sort of test? Why should not the whole country be liable to do that sort of test as a service to the community like jury service? Why should we not all do it rather than just those who need the money? If the tests are safe — and on the whole the vast majority of them are safe — why should we not say that in order to promote medical research on a random basis the whole citizenry of the country are liable to submit themselves to these tests.

Generally, I welcome this Bill. Certainly one would like to see research going ahead where there is a great need for it. There certainly appears to be problems in a small number of cases.

The need for clinical trials and clinical research is perfectly obvious. New drugs are needed. We can anticipate new drugs coming on the market from time to time. If we were to hold things as they are then medicine would stand still. However, there is need, also, for constant monitoring of the drugs which are at present on the market to find if they can be used more effectively and indeed whether they are fulfilling any definite function. However, we need to bear in mind that there is another side to clinical trials. There is the financial business side to medicine and there can be no getting away from that. Certainly, in relation to drug companies there are enormous pressures, gigantic forces working to introduce new drugs and get them on the market and whether they have any useful clinical role can, in some cases, be a secondary consideration. There is a tremendous drive to develop new products and to put them on the market.

When I used to know a little bit about this kind of stuff once upon a time I took up the rather harmless pastime of counting up the number of iron preparations listed in Mins. There were approximately 108 differing compounds which contained iron. It beats my comprehension why, in the name of goodness, it would be the interest of patients to have 108 differing sources of iron preparations available. The obvious answer is that there was a financial drive to develop those products, to get in and grab a bit of market share. That is a big problem. It is there in the background and we should not lightly forget it. Indeed, that whole anxiety to get in there and get a share of the action is a tremendous problem. There have been recent cases in the scientific and medical literature where in fairly simple terms people told lies. Subsequently they were found out which raises the question of how many people are at present telling lies and are not found out.

These are realities. There are editorials on it in the New England Journal of Medicine, which I read once upon a time when I used to be into that kind of stuff. There is the question of the branded drugs against generic drugs. Why do we need branded drugs? People will put all sorts of reasons for it but these are all background considerations. There is that great financial drive to grab a share of the market and to get these things out and sold. There is also the manner in which they are subsequently marketed, the incentives which are provided and all that sort of thing.

The Minister in this Bill seems to be going around immunising people. He has immunised himself, to begin with, against damages and he has immunised ethics committees. That leaves the question, who will be liable? Where will the buck stop if the ethics committees are not to be liable and then what will be the role of the ethics committees?

Perhaps there is a middle way but one begins to wonder why it is necessary and why are ethics committees so bothered? If they have done their job properly and if they have behaved properly why are they so bothered they might be at risk legally? I am not speaking as a lawyer but I wonder about those kind of considerations.

There are the statements of Senator Ross who visited the Institute of Clinical Pharmacology and found people from the lower income groups there trying to supplement their income. I go back to the basic point I started out with by saying I fully accept the need for clinical trials but when you see these kind of things happening it certainly makes you start thinking.

Senator O'Reilly spoke about the desirability of monitoring the health of patients at the end of the trial. Where is the end of the effect of the trial on a patient? Is it a week, a month, a year, a generation or a series of generations? The answer to this, if we are to be honest, is that nobody can say with certainty. I know that in this world you have to live with risk.

The other point, which is of significance here, is that these trials are being conducted in this country. One point which does not seem to be coming out of this is that a lot of the basic research, a lot of the scientific effort which generated the products which are being put on trial through this clinical trial business in this country, did not originate here. We are buying in this stuff that is coming in at this late stage in development. It is misleading to suggest that these clinical trials are totally serving Irish research. They are providing a way of taking on research which was done in other countries before these products can get on the market. Certainly, most of the drugs which appear on the Irish market, if I have any proper understanding of it, are not developed in this country at all. Most of them are developed elsewhere and brought in. Another consideration arising from this is if it is desirable and right that Irish people should facilitate the development of drugs that originated in another country and that they should be doing it in a disproportionate manner? I raise the question but I do not say I have definitive answers to it. There is also the point that as more of these drugs are developed they are pushing away the need for preventive medicine and so on.

There is one point specifically in this Bill which I cannot understand. I refer to paragraph (b) of section 2 which says:

where the substance or preparation concerned is to be administered to persons undergoing a course of training leading to a qualification which will entitle such a person to be registered as a registered medical practitioner, or a registered dentist or a registered pharmaceutical chemist.

It is allowed that drugs or materials would be administered to these people as part of their training. What is different about these people that they should be subject to exposure to drugs in a manner which would not be acceptable for the rest of the public? Is there something special about their metabolism? We should be told. I find that hard to understand. I can see no scientific basis for it and I cannot see it being of value in their training. The days of the wet laboratories in teaching are effectively gone. We are talking of videos and this kind of equipment. I find it very difficult to see why that provision should be necessary. I find it difficult to understand why the line is drawn at that point. What is the difference between a pharmacology student who is taking a degree in science and a pharmacology student who is taking a degree in medicine, dentistry or going on to be registered as a pharmaceutical chemist? Why should those distinctions be made? I find it hard to understand the basis for that being included in the Bill.

It seems to me that many of these students will be in a very difficult position if they say "No, thank you very much" to an over-enthusiastic or, horror of horrors, a nutty or crazy professor who decides to go one over the top in terms of what will or will not be used. The Minister is opening up all sorts of possibilities. I would be very concerned if that remains in the Bill. I cannot see how it is necessary for the proper teaching of these students. If it is necessary then, obviously, there must have been some type of inadequacy in those students who went through the system for the last two or three years when it was not possible to do that kind of thing. I have the greatest reservations and concern about that. I ask the Minister to seriously consider the possibility of leaving the provision out of the Bill. As I said, I think that is a matter for considerable alarm.

I will be brief. I am sure Senators on all sides welcome this amending legislation. I would like to commend the Minister and his Department for their foresight in bringing it forward. The original Bill was introduced here in 1987 and it is appropriate that the amending legislation should also be returned to this House first. The original Bill was introduced to facilitate research. Amending legislation that will allow our country to continue to give the lead in this field is to be welcomed. Down through the years this country has been to the fore in the medical and clinical research and it is essential that we maintain the climate to allow us to maintain our position in this area.

This legislation will allow research to continue without fear of litigation. That is what the Minister has in mind in introducing it. He and his Department saw the difficulties that had arisen since 1987 and, as a result, established a working party to review the working of the legislation and the problems that had arisen. The working party was made up of all the relevant bodies from the pharmaceutical industry, medical people and experts from the Department. It is on the basis of their recommendations that we are presented today with this amending legislation. As the Minister stated, the amendment will require that a person shall not either arrange for the conducting of a clinical trial nor conduct a clinical trial unless they have first established to the satisfaction of the Minister the adequacy of the arrangements to compensate persons who may suffer injury or loss as a result of their participation in the clinical trial. This amendment will remove the difficulties experienced by the ethics committees and at the same time will ensure that there will be adequate security to provide any compensation to the participants.

I commend the Minister and his Department for introducing this legislation to ensure that this nation can continue to be in the fore in research and clinical trials. The Minister is to be congratulated for that.

As mentioned by Senator O'Reilly we welcome the Bill. Going through the 1986 and 1987 debates I see the Act was very comprehensively discussed. We welcome the immunities in the Bill for the National Drugs Advisory Board and the ethics committees from personal responsibility. I will concentrate on the area of research. I hope this Bill will give a fresh impetus to medical research in Ireland at a time when it has come to a virtual standstill. I do not know too much about the medical line but people I have spoken to have told me that one of the optimum times for research in medicine is at the junior doctor, registrar or senior registrar level. Over the last number of years many of our doctors who wished to engage in medical research have gone abroad. While we welcome the number of non-EC nationals from developing countries to the Irish hospitals service, recent figures have shown that we have become dangerously dependent on them. They are welcome to come to Ireland as a training ground but statistics show that what was once 10 per cent or 15 per cent of non-EC nationals has now risen to between 40 per cent and 60 per cent. That poses the question what happened to our own medical doctors. When we look at the number of students who complete their medical education in our universities we see that many young people will not go into medicine because there are no jobs in this country. That is a fact that career guidance counsellors have pointed out over the last while.

In an article, The Health Board Dependency on Non-nationals, 1 October 1988 — published after the Bill which provided controversy in relation to research — I was struck by the heading to the article, "Non-Nationals; Backbone of Health Boards". It is important to put this on record. I hope we have not lost forever those registrars who get involved in research. It is surprising to find that 53 per cent of all registrars in general surgery are non-nationals, 51 per cent in paediatrics, in the North-Western Health Board, 81 per cent of registrars — an extremely high figure — and in the MidWest, my own area, the figure is 72 per cent of registrars. Those figures pose the question where have our doctors gone? They do not see in this country — and had not seen around 1986 and 1987 — the infrastructure and resources necessary to go into research. We are talking today about research. I will continue the figures. In the North-Eastern Health Board area the number of non-EC nationals are 54 per cent of house doctors, 60 per cent of house doctors in general surgery, 83 per cent of house doctors in orthopaedic surgery and 50 per cent of all house doctors in general psychiatry. They are staggering facts. Why are there so many non-EC nationals employed here and do our doctors graduating not see in Ireland a conductive atmosphere for further research?

With regard to the people who put themselves forward for clinical trials, as the Minister and Senators have said, there must be an appropriate balance between the safety of the patient who is part of the trial and the rights of a practitioner. We are alarmed at the people who put themselves forward. We heard over the last while, in controversial circumstances regarding an Institute of Pharmacology, radio interviews where people who were questioned — they may have been selective, they may not have been a cross-section of the population — put forward their reasons for undergoing the tests. They were not because they had incurable diseases themselves and would have liked to have contributed from a personal viewpoint towards the curing of those diseases but just for financial reasons. They were at the lower end of the socio-economic scale. Senator O'Reilly referred to them as guinea pigs. Yes, they do it voluntarily but it is very sad.

I was interested in what Senator Ross had to say about all of us subjecting ourselves in the same way as for jury service. However, that goes back to the whole point that there be continuous assessment and scrutiny of all those who put themselves forward. It is not something that one does lightly. It is fraught with risks, as we saw with the sad death of Mr. Niall Rushe in 1984, which caused this debate to start.

There is one point I would like the Minister to clarify. It relates to payments. I feel — and it is Fine Gael policy — that the people presenting themselves for trials should not be taxed but what they get should be treated as expenses because in any medical area the whole aspect of confidentiality is most important. I believe they should be exempt from taxation. I do not know what the moneys payable to them are but I do not think they are exceptionally high. Having regard to what they are doing and the confidentiality aspect I ask the Minister to take heed of this.

The first Bill was so controversial it was necessary to come back with this measure and the Minister as a medical man should have been more aware of the situation. However the fact that it is being brought forward today is a positive step and I welcome the Bill.

I am not really surprised that we have an amendment to the principal Act at this stage. The original Bill was debated very actively in this House in 1986. It was initiated by the then Minister for Health, Mr. Barry Desmond. It was, of course, a controversial and emotive Bill and it was brought about as a result of the death of a young man, Niall Rushe, who was participating in a clinical trial at the ICP when they were on the St. James' Hospital campus.

Many people find the whole idea of clinical trials objectionable. They say we should not have, as it were, human guinea pigs, that it is wrong. My answer to that would be that anyone who ever had a bad illness, anyone who ever had surgery would have to admit that but for clinical trials their lives might have been lost. From that point of view clinical trials are part and parcel of the world of medicine today and must continue that way.

I found the Bill in 1986 amazing at the time. It was a Bill of 14 sections. As spokesperson in the Seanad for the Fianna Fáil group in Opposition I asked that the Bill be withdrawn. I felt it was so wrong, that there were many flaws with regard to insurance side of it and on the ethics side of it. We felt at one stage that we would have to have clinical trials for the food we eat. Strange, the first speaker on the Fine Gael side, the then Senator Ulick Burke, stood up and supported me. He felt his party wanted the Bill withdrawn. However, it was not withdrawn; it was amended, amended and amended and finally it passed the Seanad and went to the Dáil. Many of the points raised in this new Control of Clinical Trials and Drugs Bill were mentioned at some stage along the line and I will refer to them briefly again.

The intention of the principal Act — it is no harm to spell it out again — is to provide a framework of control within which the following two objectives can be achieved; first, the protection and the safeguarding of the rights of those participating in clinical trials and, secondly, the facilitation of clinical research. I have to say, as one who took a particular interest in that Bill, I met at that time with the present Minister for Health and various groups who had an interest in it and were worried about the volunteers who were engaged in clinical trials, particularly on the ICP premises. I felt it was right that I should visit the ICP and Elan in Athlone and I did so and met many of the people who were engaged in clinical trials because they were, after all, the most important people in the whole debate. It was all about the protection and safeguarding of the rights of those who participate in clinical trials.

Having met them, I found that, while they were participating and helping in the whole medical research process, in reality they were there for the few pounds they were getting and they would not deny that. They would not attend those clinics if it were a voluntary situation. Some of them were unemployed, on social welfare, or on low pay, but they were there to get a few pounds together to pay an ESB bill, a television licence, insurance on the car or whatever. They all knew what they were there for. They were told they were there for an arthritis drug, a heart drug and so on. They were told about the possible side-effects and were informed at all times. They were well looked after and had agreed to the informed consent, which I think was vital and was debated at length. They had a medical examination before they attended the clinic and they had examinations during the trial, so generally all of that was well and truly tidied up even before the Bill was introduced.

I am very keen to stress that the important people in this whole debate, if you like, are the people who participate in the trials. While the scheme of control made provision, with some exceptions, for the need to have the authorisation of the Minister, following consultation with the Drugs Advisory Board and the ethics committee before the trial could proceed, it is also worthwhile saying that the need to have the informed consent of those participating in a trial was a paramount and an integral component of the whole control framework. Having got that point out of the way, it is right to spell out in the Bill who are the important people.

We had many problems at the time of the initiation of the Bill. It was certainly very wrong and flawed and we had many debates on that issue. Section 3 of this Bill seeks to amend section 10 of the principal Act. Section 10 of the principal Act says:

A person shall not (a) conduct a clinical trial, or (b) administer any substance or preparation for the purpose of a clinical trial unless such person has established, to the satisfaction of the ethics committee, that he can provide sufficient security to ensure that adequate funds are available to provide appropriate compensation for each participant who may suffer injury or loss as a result of the trial.

Those words "adequate funds" and "appropriate compensation" were debated and we tried to find out what they really meant. Now section 3 which seeks to amend section 10 requires that a person shall neither arrange for the conducting nor conduct a clinical trial unless he establishes, to the satisfaction of the Minister, that adequate security is available, thereby removing from the ethics committee the responsibility to be satisfied as to the adequacy of such security as required by section 10 of the principal Act. The difficulties that section 10 created were experienced initially in certain Dublin teaching hospitals, the Mater, St. James's and St. Vincent's hospitals. It became clear as time went on that there were legal problems for individual members and for ethics committees in general, and as a result clinical trials did not proceed I am aware that for the first three months of 1989, three research proposals were presented to the research ethics committee in St. James's whereas for the corresponding period in 1988, 23 proposals were presented.

The perception is that, unless the matter is resolved quickly, as the Minister is now doing, clinical research will stop and that would be very serious for this country. The Minister has moved wisely in this whole area of doubt and now members of ethics committees need have no fears.

Senator O'Reilly referred to the question of a national ethics committee. That matter was also raised and discussed by the former Senator Mary Robinson but was not proceeded with at that time. It was evident that hospitals would not be willing to avail of the services of such a national committee. I remember referring to the fact that, perhaps there would be indemnifiation of ethics committees by the people who were sponsoring the trials. Again, that was discussed but found to be unacceptable for a number of reasons. The question was also raised that the Minister of the day might indemnify the ethics committees but that, too, was discounted. The legal advice given to us at the time was that such a move would be ultra vires to the Act and that it was part of a broader question of principle involving indemnification of bodies by the Minister which was not acceptable. Those aspects of the problem were discounted for the reasons I have given. The Minister has decided that this Bill is the correct way forward and that a solution can only be found by a suitable amendment to the principal Act. In addition, the Minister has gone a stage further; he has sought to provide certain legal immunities for the Minister, the Drugs Advisory Board and the ethics committees in relation to their functions under the principal Act. This, too, is very welcome and the ethics committees and the Drugs Advisory Board in particular will greatly welcome it.

The Minister has acted wisely and well. This legislation is necessary if clinical trials and research are to continue. It would be an absolute shame if there was any diminution of research or clinical trials. They are continuing in certain places but the people in health boards and in the teaching hospital are affected most. It would be very wrong if they were denied the opportunity to continue the great work they did in the past.

I fully support this Bill and congratulate the Minister for bringing it forward as quickly as possible. I am aware, having spoken to him, that he was at all times extremely anxious to have this Bill introduced but I knew there were legal problems — which is understandable because it is a complex legal matter — with the parliamentary draftsmen. If there were any delays they were not the fault of the Minister, Deputy O'Hanlon, who was anxious at all times to have this Bill passed quickly, so that medical research would continue as heretofore. We should warmly congratulate him for introducing this Bill.

Like many of the other speakers, I welcome this Bill which seeks to give immunity to the National Drugs Advisory Board and to introduce three amendments basically to the principal Act. The principal Act was introduced largely in response to the untimely death of Niall Rushe. At that time, following his tragic death, a spotlight was turned on the category of people who were largely being used as healthy volunteers. They tended mainly to be down and outs, people who were probably unemployed and socially disadvantaged. There was great concern that their rights as far as possible should be safeguarded and that their participation in drug research would be made as safe as possible and, therefore, as acceptable as possible.

Unlike Senator Ross, I believe that participation in any drug studies carries a certain element of risk both to health and in certain instances, to life. If everything is done according to the book, so to speak, the objective is that this risk be minimised as much as possible. However, we should be conscious of the fact that there is a risk involved.

It was in this context that the need for legislation to control clinical trials on new drugs was accepted by all, and that the legislation was introduced in 1986. Unfortunately, perhaps because it was done in such a hurried fashion, it appears to have been poorly written, somewhat cobbled together. It evoked unprecedented criticism from all branches of the medical profession, universities and various research bodies. There were an enormous number of amendments tabled to that Bill, many of them sponsored by the Minister. Basically, it was a bad Bill and it remained a bad Bill even though we endeavoured during its passage through the Seanad and the Dáil to improve it. That stemmed mainly from the fact that there had been little consultation between the Department of Health and those who were most involved in research — the universities, teaching hospitals, medical schools, and so on.

To the Minister's credit, it might be said that he delayed giving effect to that Act because he delayed signing it. However, when it was signed and came into effect, what had been predicted happened. Ethics committees resigned in most of the big teaching hospitals, and not surprisingly, when they realised the penalties. There were rather draconian penalties, such as three years in jail and fines of up to £10,000. When ethics committees and, indeed, researchers realised their liability in the event of, perhaps, the failure of an ethics committee to provide adequate security for compensation for every possible eventuality, they saw the difficulties they could be faced with.

The Act provides volunteers with the protection that we all like to see. Basically, the Clinical Trials Act made research safe by stopping it. The heading of an article I read stated that research had virtually come to a halt, and this is a most unsatisfactory position.

There is no doubt that there is a need for urgent amendments so that medical research can resume or continue. Ireland has a considerable reputation for research and has undertaken research for organisations such as the World Health Organisation and others. However, those organisations tend to run away from countries which make research excessively difficult. I am glad the amendments are now being tabled. I hope they will allow research to get under way and make Ireland once again a favourable location for such research.

A number of bodies are of the opinion that, basically, what is required is to start with a completely new Act. Of course, the current legislation would remain in existence until that happened and it would obviously be a long and tortuous process. Already over a year and a half or more of research has ground to a halt and we do not want that situation to continue. Although the Act is fundamentally flawed, it is probably better that the amendments should go though and I welcome them. The Bill will give immunity to the National Drugs Advisory Board and also, certain immunity to ethics committees and at the same time it will provide the necessary protection for volunteers. I hope that as a result of this Bill there will be an adequate balance and that the Bill will have a speedy passage through both Houses of the Oireachtas.

I welcome the Bill. It is a short, comparatively simple measure that is very timely. As the Minister is probably aware, I have been asking regularly for the past six months on the Order of Business for an indication that this Bill would be introduced for the reason that the application of drugs in the treatment of patients, particularly with acquired immune deficiency syndrome, has been held up due to the inadequacies of the original Bill.

I would like to comment on one or two things I heard during the debate. With the greatest respect to my distinguished friend and colleague, Senator Ross, his suggestion that there should be mandatory use of the entire citizenry of the country as a kind of pool of guinea pigs is just about the most absurd thing I have heard in the three years I have spent in this House. Senator Ross asked why this could not be done. There are several clear reasons and I am sure the Minister is aware of them but there is no harm putting them on the record. The principal reason is that it violates the Irish Constitution; it violates the European Convention on Human Rights; it violates virtually every international instrument to which this country is a signatory. Almost all these instruments guarantee and underwrite the right to bodily integrity on the part of the citizens. One cannot conduct trials on an involuntary or even a random basis throughout the country. One cannot go around sticking needles into people without their consent. As I said, it is a completely absurd idea and I wonder if the Senator actually believed in it himself.

There was much discussion of the original Bill which addressed the principles of the original Bill rather than the reasons for this amendment. There was a good deal of talk about the need to protect volunteers and so on. This Bill was introduced as a response to the tragic death of Niall Rushe in circumstances that illustrated that there was a loophole in the legislation.

There was no legislation.

There was a lacuna in this legislative area because there was no Bill. I stand corrected by Senator Ryan who is, as always, minutely particular and exact in what he says.

I read some of the debates which took place in the Seanad in October 1986. I do not always agree with Senator Fallon but on that occasion he made a particularly fine speech. He pointed out that the Bill being introduced at that stage was defective, and I quote:

We have a Bill...which has been prepared without real consultation during the drafting stage, with concerned professional representative bodies. The major weakness of the Bill lies in its title on which I will comment later. The general opinion is that it goes too far and it is almost certain to impede medical research progress here.

The Bill then fell between two stools because there was an election and it was reintroduced without the kind of substantial amendments it needed at that stage. Some of those amendments at least are contained in this new legislation.

My reason for welcoming this Bill is not so much just that medical research is being impeded but that one of the principal effects of this legislation was to hold up the availability of drugs which were on offer from pharmaceutical companies, particularly to patients with acquired immune deficiency syndrome. The specific instance I gave was the question of DDI. I gather that as a result of the operation of this Bill, this drug will be made available. There are about ten to 15 patients who have an adverse response to AZT and for whom this different drug will be available as a suitable prescribed treatment. For that reason I very much welcome the Minister's initiative in introducing this legislation.

I note also that the former Minister, Mr. Desmond, on 27 May 1986 addressed the objectives of the Bill as it was originally initiated. He said:

The ultimate objective of the process is to ensure the availability of a safe and effective drug for treating a particular illness or condition and which at the same time conforms with safety, quality and efficacy criteria laid down by national regulatory bodies for the marketing of such drugs.

It is quite clear that it did not succeed in this objective. The Bill, as amended, may go quite a long way towards making these drugs available for the treatment of patients and, therefore, I welcome it.

I do not intend to speak at length because the intention of the Minister is to get this Bill as speedily as possible on to the Statute Book so that those who are ill may have immediate access to treatment and we must bear this in mind. To me, this is the most important aspect of this legislation, not so much the research, although I heard part of what my distinguished colleague, Senator Hederman, had to say. Like her I am aware of studies initiated under the World Health Organisation; I am aware of one study in particular which eventually was carried out in Belgium because, although we had the expertise and the professional equipment here, we simply could not get the go ahead to conduct it here. For that reason also I welcome the Bill. It may not be perfect but then in this life there are very few things that actually attain perfection.

Apart from yourself.

I follow in Saint Brendan Ryan's footsteps as much as I can, meekly and with humility, and one day I may attain his particular degree of perfection, although I hope without having to join what he described as his church.

My interest in the Bill is a very practical one; its passage will release drugs for the treatment of people with serious illness. Those of us who are moderately healthy need to bear in mind the anxiety of people who are ill. It must be particularly galling to find that there are drugs available which would ameliorate their condition but, for a technical reason and because of a lack of urgency with which this matter is treated in a legislative form, they are denied the positive beneficial effects of research. I very much welcome this Bill.

There has been a lot of talk about medical research. The impression we got from a number of speakers is that medical research ground to a halt because of restrictions of drug testing. I would have thought as we reached the end of the 20th century, that we were beginning to have a broader definition of medicine than the administration of substances. There is a huge volume of work to be done with existing approved medications or with alternatives to drug therapy which would usefully and constuctively be done by the medical profession. For instance, a vast range of already approved drugs are useful in dealing with pain and the dying as the medical establishment now realise that there is more to medicine than making people well. There is the huge area of caring for the chronically and terminally ill. It took the hospice movement to get this issue across to a rather less than sensitive medical establishment. That area of research does not need an enormous amount of extra drugs; it needs an enormous amount of education and research.

The support of seriously ill people and their families has nothing to do with drugs but has an enormous amount to do with the proper practice of medicine and the efficient use of human resources and equipment. All of that is a more than worthy area of medical research. It is a little breathtaking to have the magic bullet image of medicine still with us as we begin, often with the less than wholeheated enthusiasm of sections of the medical establishment, to appreciate that the proper form of medicine is, indeed, directed towards the well being of the whole person and does not treat the human organism as a sort of a biochemical machine which can be improved or disimproved simply by the administration of a variety of drugs. Drug therapy is an important part of medicine but it is neither the central or the only part of medicine. I am not in any way disputing the merits or the importance of the Bill, but to suggest that medical research is exclusively about which drug works under what circumstances, is to do a great disservice to medicine.

I have no problems with the Bill. I welcome it and I appreciate in specific terms the reasons Senator Norris has given for his welcome but, in general, it is a most welcome Bill. I would not like to even give the impression that I was unhappy with the old Act. I laboured long in this House with one of the Minister's predecessors, Mr. Barry Desmond, on the minutiae of that Bill and have rarely been so well advised by various groups about what was wrong with it in a variety of directions, ranging from the medical profession through to families of people who had unfortunate experiences with drug trials. The Bill was worthwhile; the Act is worthwhile. It is extremely important that we have legislation like that. I do not believe that at the end of the 20th century, there is the remotest reason for the average lay person to adhere to the "trust me, I know what I am doing" school of professional responsibility. We trusted engineers, of which I am one, scientists, technologists and other experts with our environment and they damn nearly destroyed it. There is no reason the laity should ever believe that there is such a thing as a superior professional mind that knows better than the average lay person who is good for the world, themselves or anybody else. Therefore it is extremely important that all areas which involve the interaction between human being and various substances which are more or less safe should be properly regulated in the interests of the people who, perhaps, for a variety of reasons undergo those trials. I am very wary of all professional establishments and I say that as a member of a profession. I am not at all sure that any profession can be relied upon to keep the priorities it should have to the forefront at all times. I will come back to that in a moment.

It is important to remember that clinical trials do involve risk. All science, all studies of the interaction between substances and either a human or animal organism involve risk because science is essentially and experimental subject. It is not based on some sort of wonderful theory which can apply in all cases. It is based on the painstaking building up of models of interaction and behaviour based on experimental evidence. Things can go wrong. There are well documented cases of substances which are harmless to animals being quite lethal to humans. There are well documented cases of substances, which are extremely helpful to humans, being harmful to animals. There is the rather hair raising story, to which no blame should be attributed but which is nevertheless true, about the research in the thirties into the use of PVC monomer as a possible anasethetic in medicine. It was, fortunately, discarded and then in the last 20 years it has been discovered that PVC monomer is a carcinogenic substance. It was not because it was identified as a possible carcinogen that it was discarded, but it could have been.

Science is by definition fallible. I am a scientist or a technologist, depending on how one wants to describe me, or, perhaps, both or maybe something less. Before Senator Conroy reacts I might as well cover all options. As I said, science is, by definition, fallible. The methodology of science is to learn from the limitations of experimental evidence, from the anomalous experimental results and to build on experimental evidence. Science is not an abstract. All areas of science are experimental and they are only as good as the experimental data. There is no way a person who is undergoing a clinical trial of a new drug can be given any categorical assurance that the drug is safe. The nature of science is that it cannot ever give absolute guarantees of safety. All that can be done is to make a reasonable asessment of the risk involved relative to the possible benefits to be derived. The question that arises in all clinical trials is who will benefit. Is it for the benefit of sick people or for the benefit of a large multinational? It is extremely important, therefore, that there should be careful and detailed regulation of how such trials are conducted because there is a clear need to assess a risk vis-á-vis a benefit for any test which involves the interaction between a human being an a new drug.

It is important, without wearing an ideological hat, to remember that multinationals are far from benevolent organisations. They have an unfortunate record, for instance, of moving drugs that are, perhaps, less acceptable in the Western world to be prescribed and sold in Third World countries. A famous multinational, which allegedly devotes itself to the well being of young babies, have used enormous resources to persuade women in Third World countries to use artificial baby food instead of their own breast milk, and in the process guaranteed the ill-health of thousands, if not millions of babies, who become ill by contaminated water supplies. That is not the benevolent image that we see in the advertisements but it is the reality of the experience of poor people in relation to multinationals. People deserve, and need, to be protected and the Act will do that when it is amended.

It is also true that most healthy people who are involved in those trials are the wretched of the earth. They are poor and deprived. I do not know — and I do not know if anybody else in this House knows — anybody in the general income bracket of Senators or TDs who has a reasonable amount of leisure time, who has ever freely undergone a clinical trial for any reason. Why not? Is it because we do not like the company? Is it because our time is too precious? Is it because we know there is a risk involved? Why is it that the overwhelming majority, if not the unanimous, view of those of us who have a reasonable amount of income is to avoid under every possible circumstance the possibility of having to do what we all believe is apparently necessary, provided somebody else does it for us?

We cannot duck the difficult issue of how people should be persuaded to undergo or to participate in clinical trials by talking about freedom. I am not talking about the objective of this Bill but of the Act in general. The truth is that almost everybody has the freedom not to need the relatively small sums of money that people who take part in clinical trials get paid. Those of us who have that freedom do not have to worry about whether we get £200 out of a clinical trial. Therefore, it has a reasonable conclusion that those who do, who are not much different from the rest of us, do it for the money. If the risk is so great that we will not do it, why is the risk not so great for those who will do it? That is where I think Senator Ross, through I do not always agree with him particularly in recent times, had a point. To leave it to those whose economic freedom or lack of it dictates that they have an enormous incentive to participate in these trials is in fact to discriminate quite unfairly against those people.

I am not happy with the whole idea of commercial clinical testing, of large scale institutions set up specifically to deal with drug trials. There is a slight stench of people making vast fortunes on the backs of the poor in such an operation. I am not talking about the legitimate work of ordinary medical practitioners in the pursuit of ordinary medical practice. I am talking about dedicated research institutions. I do not like it.

I have a very simple solution to how it would deal with the question of clinical trials, because ultimately clinical trials are being done because products are often produced by companies who hope to make money out of them. All of those companies have shareholders and it would be very interesting to suggest a condition of ownership of shares of a pharmaceutical company would be that the shareholders would actually become the guinea pigs for the clinical trials by those companies. That would relate the risk to the major beneficiary.

I suggest that the share price of every major pharmaceutical company in the world would go through the floor tomorrow if all of the shareholders felt that they had an obligation to actually participate in the trials that were being conducted, allegedly with minimal risk, on their behalf to sell extra drugs to the world. It would be very interesting that a condition of benefiting from the share-holding be participation in the risk that creates. That is good capitalist economics, in my view, that those who take the risks get the rewards. In this case those who take the risk get miniscule rewards and those who just put in their money get the biggest rewards. I would like to turn it around a bit. It will not be done, but it would actually work and it would produce a very healthy discrimination between those drugs and trials which were necessary and those which were not.

There are, of course, quite a lot of things in this Bill that are most worthwhile. I accept that it was defective to leave the National Drugs Advisory Board membership with a serious risk of litigation for doing a job which is thankless and which I know, as anybody in this country knows, is done with a considerable degree of conscientiousness. Therefore, I am glad that the NDAB are going to be given a degree of immunity from legal action.

I am also more or less happy that ethics committees are going to have a similar immunity but I would like the Minister to think a bit more carefully about the basis on which ethics committees are set up. I would have to say that I cannot see what particular expertise some of the people I have seen as named members of ethics committees — and I am not going to get involved in anything that would even hint at who I am talking about, largely because I am remembering three years ago — had to contribute on an ethics committee in assessing the ethics or otherwise of a particular test. The consequences for members of having to accept full legal liability is perhaps too harsh but there could well be some need and the need for the Minister to be very careful in assessing the value of having certain individuals as members of ethics committees.

I am not so happy at all about the Minister — as Senator Upton said, with his magnificently creative English — immunising himself. There is a slight hint — if I dare mention it without bringing back awful unhappy memories — of a certain disaster for haemophiliacs of recent memory in the immunising of the Minister from legal action.

There are a few other things specifically on the Bill that I would like to talk about. The Minister says that the recommendations of the working group were taken into consideration. Has the report of that working group been published and, if not, would the Minister like to publish it? We have an extraordinary record of secretiveness in this country, of non-disclosure of reports, and if there is an authoritative scientifically based report then we ought to be able to adjudicate on the extent to which the report of that working group has actually been, in the Minister's phrase, "taken fully into consideration". He did not say he had accepted the recommendations; he said he took them into consideration. That is a great phrase. I can take anything into consideration and then dismiss it. It would be interesting to have a look at it.

I have another dilemma and I am not sure if it is a serious one. In three different places — once in the Act, once in the Bill and once in the Minister's script — three different words are used, I think to mean the same thing. In the Minister's script in relation to the amendments to section 6, he specifically says he wants to exclude trials "where the intention is to prevent disease." The Bill says that the principal purpose is "to prevent disease" and the Act in section 9 refer to "the principal objective". So, we have intention, purpose and objective all thrown together in three different places — once in the Minister's script, which is not of any legal significance; I do not understand why in section 2 of the Bill we have a reference to "the principal purpose of the administration" whereas in section 9 of the Act we have a reference to "the objective of the administration." What is the difference between an objective and a purpose? I dug out the large and enormous version of the Oxford Dictionary in the Oireachtas Library and I cannot find a difference between an objective and a purpose. There are different meanings for the words, but there are meanings which overlap for the words "objective" and "purpose"— I did not check "intention" because I did not have the Minister's script. As one who takes a considerable interest in the Committee Stage of legislation, I would like to know did the parliamentary draftsman suggest the word "purpose" rather than "objective", or was it just the different parliamentary draftsmen, because I know the parliamentary draftsman is kind of a collective noun for a whole lot of individuals who claim to be the one person?

It seems to me that we could do with a reasonable simplicity of language and a reasonable consistency of language in this matter. I would suggest to the Minister that if "objective" was good enough in the Act, then "objective" should be good enough in the amendment to the Act. Section 9 (7) of the Act — and I will want to come back to it because it is rather a problem for me — refers to "where it is proposed to conduct a clinical trial of any person suffering from an illness the remedy for or alleviation of which constitutes an objective of the trial." That is where it is an objective. When it comes to the Bill we deal with "the principal purpose... is to prevent disease... or to save the life, restore the health, alleviate the condition..." I do not understand the difference between an objective and a purpose and I do think it makes legislation that is complicated enough even more complicated to use different words to mean the same thing.

On a more serious note — and I would like a specific indication of this in the Minister's reply — how does the amendment proposed in section 2 of the Bill fit together with section 9 (7) of the Act, because in section 9 (7) of the Act there is a clear reference to a clinical trial on any person where the remedy for or alleviation of which constitutes an objective of the trial. That is called a clinical trial in the Act. What seems to me to be the same thing is now being called not a clinical trial in the amendment to the Act and it appears to me that section 9 (7) ought to have been deleted or ought to be deleted from the Act in order to maintain consistency. Otherwise, there is ambiguity in the amended legislation between the amendment to section 6, which is a redefinition of a clinical trial, and the reference in section 9 of the Act to a clinical trial, which seems to me to be almost identical with the excluded definition in section 6. I think there is an anomaly there which could well be — and I am not playing games — be the sort of thing which would produce more of the problems that have made this Act such a problem for some people in some areas of medical care.

There is another little problem with the wording of the amendment.

... the principal purpose of that administration is to prevent the disease in or to save the life, restore the health, alleviate the condition or relieve the suffering of, the patient.

I presume psychiatric patients are covered by the amendment. It could be argued and some people with a slightly more radical outlook on the world than I would perhaps wonder about some of the medical jargon used about many forms of mental illness, which perhaps are more environmental and stress-related and emotional than physical. It would be no harm to have it clarified.

Finally, given the redefinition, which I support in principle, that where drugs are being administered to achieve the objectives listed, the purposes listed or the intentions listed depending on which word you choose to use, that where drugs are being used like that they should not be subject to the extraordinarily complex procedures, and justifiably so, of the commercial clinical trials. It is also important that quite clearly the only reason drugs would be administered under those circumstances would be for the principle purpose to prevent disease or to save the life, etc. Therefore, it is extremely important that there should be no element of reward involved for the medical practitioner, or indeed dental practitioner, who administers such a substance. It should not be a response to any incentive offered by a drug company. It should be done exclusively on the basis of the merits perceived by the medical practitioner of that particular substance to possible alleviation of the condition of the individual. No question of financial award should arise.

Secondly, it should be equally clear that in the case of a drug being administered to somebody who is sick there should be no question of financial reward to the individual who is unwell. To suggest that we would offer rewards to people who are sick to take medicine that will make them better would be somewhat unacceptable, at least to me. As well as that, I would be worried that if doctors could be paid by multinationals to use drugs in the fashion described in section 2 of the Bill, then it could likely lead to many people getting around many of the provisions of the Clinical Trials Act and testing their drugs on a commercial basis on sick patients, the commercial arrangement being between the doctor and the multinational. We should make a very clear distinction between commercial drug testing and medical drug testing or medical trials of drugs. Medical trials should be carried out by a doctor because he or she believes this possible drug might be useful to a particular group of patients. There should be no financial incentive or reward.

There is a slightly less than savoury odour about the relationship between drug companies and some aspects of the medical profession. My wife is a doctor which most of the world knows, because my wife's alleged salary, which is usually minuscule, is often quoted in some sort of way apparently to put me in my place. I am never too sure why, but it is used from time to time. My wife is a doctor——

Deputy Smith has never been one of these people who try to put me in my place. He is far too kind.

Unsuccessfully.

Far too kind, gentle and upright for that sort of thing. There are in the medical profession what are described as "drug do's", a most unhappy operation which involves drug companies entertaining in grand style large sections of the medical profession to meals in the finest restaurants simply to make them appreciate the clinical merits of a particular substance. I do not know the connection between persuading people about the medical worth of a particular substance and wining and dining them in the best restaurants in Cork or Dublin. I can never understand the clinical or scientific connection between one or the other. It should not happen. Medical decisions on what is good for patients and what is good for people should be done on the basis of the medical evidence provided in a clinical atmosphere without any of the trappings of a sort of an incentive. The sponsorship of various conferences just miraculously happens to involve the possible encouragement of people to use drugs that are provided or manufactured by the company which sponsors the conferences, or the sponsorship of people to travel to conferences where they learn about drugs that perhaps the sponsoring company has an interest in selling.

All of that is not the way, in my view, to convince ordinary people that the simple objective decisions are based on the merits of the case. Therefore, I am proposing on Committee Stage to introduce a couple of amendments to deal with that so as to ensure that there is no commercial involvement in the decision to prescribe substances to people who are ill. We can leave the commercial drug testing to the commercial sector and we can ensure that any trials or any administration that is carried out for sick people will be on the basis of nothing more than the merits of the case. No rewards of any kind should be offered, either direct in cash or implied in any way, to try out a particular drug on patients and no reward should be offered to patients who agree to accept particular drugs.

I will be very brief. In the debate on the control of Clinical Trials and Drugs Bill in 1986, which subsequently became the Control of Clinical Trials and Drugs Act, 1987, most of us welcomed the Bill. It emerged, however, that there was a need on Committee Stage for a very detailed and elaborate debate and right throughout the other Stages so as to satisfy ourselves about all the implications of such a serious business as clinical trials, particularly with regard to some of the observations that emerged concerning the death of a person around that time. We felt that at the end of it all sufficient scope had been given to ensure that there would be a tremendous amount of vigilance and that the risk to people would not outweigh the objectives of the trials.

In that debate in 1987 the majority of us felt happy that the ethics committee was given adequate security. However, we now see that one of the purposes of this amending legislation is to remove from the ethics committee the responsibility to be satisfied as to the adequacy of such security, as required by section 10 of the principal Act. It then goes on to seek certain legal immunities for the Minister, the National Drugs Advisory Board and the ethics committee in relation to their functions under the principal Act.

I know the Minister gave some explanations in his Second Reading speech. But as somebody who expressed a lot of concern in the earlier debate, I am wondering if anything went wrong that we did not hear about. Was it that because of the rate of pace of change new circumstances emerged that were not foreseen at the time of the other Bill and have brought about this measure? My contribution could be by way of question if we had a Dáil system of questions here. We do not have that, so this is merely a brief expression of concern as to whether all the reasons it is necessary to safeguard the ethics committees are known. Have there been many claims against them, or what exactly is the situation? Is it just that the circumstances of the time have changed because of the pace of change throughout the world or what is behind it?

I was satisfied on that occasion and indeed fell out with a few friends by supporting the Bill. Therefore, I would like to know all the reasons we are amending it. I trust the Minister will deal with that when he is replying. Will the Minister, the National Drugs Advisory Board, the ethics committee or anyone have comprehensive control, or what is the story relating to it? It would be a good idea to monitor these matters and look at them from time to time. I would like more information than was available in the Second Stage speech. The Minister might tell us if there is anything other than the reasons given in the Bill, which are broad generalities. These are necessary in many Bills but in a Bill like this it should be stated.

I would like to take up where the previous speaker left off in regard to what monitoring has gone on and what goes on in relation to the Department or the functioning of the ethics committee in relation to trials and experiments. As the previous speaker indicated, all of these clinical trials and experiments which are very necessary, have gone on for many years without too many hiccups, but one came to light some years ago when an unfortunate person died. He happened to be a constituent of the Dún Laoghaire area. A lot of things came to light at the time in relation to down-and-outs being brought in, of people who were not very healthy being paid small sums of money. Some of the criticism at the time may have been unfair and may not have been deserved, but it brought home to people some of the experiments and trials that were going on.

What monitoring has been done since that time and since the introduction of the Act? We bring in a lot of legislation but there is no monitoring of it, how it is being administered and policed? I would ask the Minister, when replying, to indicate whether circumstances have improved. I do not know how extensive the trials are or how many people are treated and given drugs. It is very important, particularly where the lives of people can be at risk, that there are safeguards. Doctors and others performing within certain guidelines have to have some backup and have to be covered, as provided for in the Act. Have there been many cases, have many claims been submitted or have many things gone wrong? As progress is made — and greater progress is going to be made in the future as there are now some highly specialised drugs — it is important with drugs of this nature to have an element of security.

I would ask the Minister to indicate what monitoring has gone on since and if he is satisfied with it. Is he satisfied that there has not been this taking in of down-and-outs which went on at the time, paying them a few pounds for possible experiments, and have there been many claims?

I would like to express my gratitude to the Seanad for their very careful consideration of this Bill and in particular to the Senators who contributed to the debate. I know that the Minister for Health will be taking careful note of the contributions that have been made here this afternoon.

In his introductory speech, the Minister for Health stated it was a prototype piece of complex legislation and in such circumstances teething problems such as those we are now dealing with were a real possibility.

I would say to Senator Harte that there is no hidden agenda. There is nothing happening which is not well known to the public at large. This Bill has been introduced in order to deal with some of the problems that have emerged, particularly in relation to the ethics committee. The Bill will deal effectively with those problems which have arisen in the operation of the Act and in particular the difficulties caused for ethics committees. It will enable the committees to fulfil their roles effectively and with confidence.

I am confident that the measures contained in the Bill and supported here by Senators on all sides, will restore confidence in Ireland's position as a favourable location for clinical research and ensure that the original twofold objectives of the Act, namely, to facilitate clinical research while, at the same time, affording protection to participants in clinical trials, are fully realised and implemented. At the same time the working of the Act, as amended, will continue to be closely monitored and kept under review. The Minister is prepared, should the need arise at some future date, to further amend the Act in the light of ongoing experience of its operation.

Senator O'Reilly referred to the role of ethics committees and the assessment of participants. This is provided for in section 8 (4) of the original Act, and the House should know that the Department of Health have published guidelines which are available to ethics committees.

Senators Ross, Jackman and Ryan also expressed concern regarding the participants. They are volunteers and we owe a great debt of gratitude to the participants, without whom research in this vital area could not take place. Sections 8 and 9 of the Bill set out to protect the interests of the participants. Reference was made to compulsory testing. This will not be acceptable and it is also very likely to prove, should it be contemplated, to be unconstitutional. We have plenty of examples of the success story of voluntary efforts in this regard. One could mention the Blood Transfusion Board, which is totally on a voluntary basis but operates very effectively; and one could not imagine any change which would make services like that go into the domain of compulsion.

There was a suggestion that payments be treated as expenses. The Minister for Health has many responsibilities and he may wish at times to have absolute control over the financial matters of the State. But I am sorry to say that these matters reside in the Department of Finance and, much though the Minister for Health might like to control everything in this regard — it might make life a lot easier for him if he could — it is unlikely for the time being at least while he remains in his present portfolio that he will have a say as to how payments are treated. They are clearly a matter for the Department of Finance. The original Act was initiated by the Minister's predecessor, Mr. Barry Desmond.

Senator Upton referred to section 6 (2) (b) of the Act as the new provision of the Bill. In fact, this provision is part of the original Act. It provides for no compulsion but clearly acts on a voluntary basis. Medical students may wish, as part of their training, to experience the effect of medicines so as to understand the effects which these medicines are likely to have on their patients. That seems to be a completely different area and the provision merely allows them to be exempted in circumstances like that from the control of this Act, I believe that is perfectly acceptable.

Senator Brendan Ryan referred to section 9 of the Act, which deals with licensed clinical trials which may include persons who may be patients. Section 6 of the Act, as amended by section 2 of the Bill, provides exemptions. In particular, it provides that medicines may be administered to a patient in certain circumstances without having first to obtain a licence. This may be necessary where the life of a patient is at risk and may not permit time for obtaining a licence. I should say also that clearly here we are talking about the relationship between the patient and the doctor which has to obtain all the time.

In case Senator Ryan considers that this would be a way of general by-pass of the control of the regulations and the controls which are enshrined in this Bill, I would say to him that the normal requirement would be to obtain a licence through the procedures laid down in this Act. There is no sidestepping of that, there is no way that can be avoided and the use of the suggestions which he has made would not really prove successful or could not circumvent the terms of the Bill.

Senator Cosgrave asked what improvements are taking place in the policing of trials. Trials are first assessed by the NDAB before being approved. Ethics committees must also be satisfied of the need for the trial and the provisions for participants as provided in section 8 of the Act. The Minister for Health is satisfied with the level of monitoring what is taking place.

I would like to thank all the Senators who have contributed and the House for giving a speedy passage to Second Stage of this important Bill. I hope we can make further progress later this evening on the remaining Stages.

Question put and agreed to.
Agreed to take remaining Stages today.
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