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Seanad Éireann debate -
Wednesday, 1 Oct 1986

Vol. 114 No. 1

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

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

We all accept the need for legislation to control clinical trials on new drugs. The public have shown concern in regard to this for quite some time, going back to the thalidomide disaster of the 1960s which resulted in a widespread public demand that pharmaceutical companies be compelled to ensure the safety of their drugs, and more recently in 1984, on the unfortunate death of the young man who was undergoing a phase 1 healthy volunteer study. Clinical drug trials involving the use of human subjects are emotive and controversial. Many people find the notion of people being paid to put their bodies and minds at the service of drug companies objectionable, but the reality to be faced is that such tests are essential if new drugs are not to be released on to an unsuspecting public without having been properly investigated for possible health risks.

The fundamental purpose of medicine is the alleviation of suffering and the control of disease. As we all know, dramatic advances in the control of diseases which in the past were incurable or resulted in chronic ill-health, have been made. These advances have been directly dependent on drug research which has resulted in the production of much more effective and safer drugs. Indeed much of the modern surgical procedures have been successful because of the availability of new safe drugs. Today there is an ever-increasing demand from the medical profession and from the general public for more effective and safer drugs. Despite a degree of unwillingness to accept the necessity for research, by many people, clinical research and drug research must continue so that people who now suffer can be afforded the hope and relief which is their just right. It is regrettable that many of our existing drugs fall short of what is required, so the good work of medical research must continue.

This Bill has been almost two and a half years in the course of preparation. I would have thought that we would have received by now a Bill that could have been welcomed by all interested groupings. Apart from the fact that we have a Bill which most people believe to be very much out of line with other countries, 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.

There is the use of the words "substance" or "preparation" without any positive or firm definition. These are the key words in the title. It is regrettable that further definition has not been available within this Bill. As currently drafted, it would appear too that ministerial approval is required for all studies involving not alone new or existing drugs but substances and preparations. We must assume that this will include studies of dietary manipulation. Where the words "substance" and "preparation" are, this interpretation seems to include normal dietary constituents. Normal dietary studies were always considered safe and desirable and they should not form part of this Bill. The Bill is all-embracing Bill and is not what was expected by the public and the concerned medical profession.

The title of the Bill refers to "medical or harmful effect". This is a negative approach, because the purpose of drug testing is to produce safer and more effective drugs rather than to determine their harmful effects. What was expected was a clear distinction between drugs in ordinary routine clinical practice and new drugs that are not fully recognised for clinical purposes. The Bill seems to me and to many other people to encompass not alone new drugs, but all established drugs which are in every day medical use including those which can be bought without prescription and to include normal food substances, things such as vitamins and fibres. What is required is a Bill restricted to the investigation of phase 1 drugs and not all aspects of medical research including normal dietary constituents. It would seem that the Minister wishes to have his finger in everybody's pie and this is incorrect.

Amazingly there is no mention in the Bill of the National Drugs Advisory Board. They are referred to in the explanatory memorandum. They were referred to in the Minister's Second Stage speech, but they are not mentioned in the Bill. I do not have to tell the Minister that the National Drugs Advisory Board are a tried and trusted organisation appointed by the Minister for Health and loaded with expertise in this field. They are not referred to in the Bill. It seems to be a vote of no confidence in that grouping. I regret this.

The work of the National Drugs Advisory Board over the years has been well known and well acknowledged. I can remember reading of a drug called Opram which was withdrawn from general use sometime ago in the UK and other countries, where it had been approved. But this drug was never allowed into this country because of our experts at the National Drugs Advisory Board who were alert, competent and were about their business. We all know they enjoy a worldwide reputation, yet we ignore them in these formal discussions, we ignore them in the Bill. That they are not mentioned in the Bill must be a matter of concern. Ministers' statements and explanatory memoranda are all right but what counts is what is in the Bill. That is what becomes the law of the land.

The omission of any reference to the board, I stress, must be seen as very serious. Without clear recognition of the board's importance in the future of scientific evaluation of clinical trials they will have a much reduced role. This would create many difficulties for that body. At this stage I would have to urge that the position of the board in relation to clinical trials should be made crystal clear by a formal mention — a clear intention within the Bill itself.

We all know that the National Drugs Advisory Board are the only competent, independent body in this country to adjudicate on difficult, complicated drug research protocol. This expertise is not available in the Department of Health. It is the Minister for Health who appoints the members of the National Drugs Advisory Board because of their obvious knowledge and expertise. Why he should choose to ignore them by not mentioning them in the Bill certainly baffles me and I am sure baffles many others also.

The role of the Minister is well and truly defined. The absolute power sought by him is referred to in very many places in the Bill. Again, this must be a point of concern. It is true to say that it has been a feature of Bills from the present Minister for Health that his role should be well and truly defined, going back to the Nurses' Act and the Dentists' Act. However, this is a totally different type of Bill. It is a Bill which involves very complex and very scientific matters. Why the Minister seeks to have such power in such a very complex area is difficult to understand. Reference to the Minister in the Bill is made in subsection 2 (1). Subsection 2 (2) mentions him in the application of the conduct of the trial. Section 3 states that the Minister shall as soon as is practicable grant permission or otherwise. Section 6 states right through that he may revoke a trial. Section 7 mentions his satisfaction with the competency of the ethics committee and so on. I would agree with some of the points but there is too much ministerial intervention in this legislation. Right through, the Bill is riddled with ministerial mention and for the type of business about which we are talking, ministerial or bureaucratic structures in general almost certainly cause delays. Delays in this kind of business can be very important and have very far-reaching effects on the industry.

There must be reason to feel concerned. I referred briefly to section 3 and to the four words "as soon as practicable". In relation to a proposal to arrange for the conduct of a clinical trial, the application has to be made in accordance with section 3(1). The section goes on to say that

the Minister shall, as soon as practicable — (i) grant permission for the proposed clinical trial to be undertaken in accordance with the application or, (ii) grant permission for the proposed clinical trial to be undertaken in accordance with the application subject to such modifications or conditions as he may specify, or (iii) refuse to grant permission for the proposed clinical trial to be undertaken.

Those four words can mean anything. At the moment, clinical trial protocol is dealt with by the ethics committee and by the National Drugs Advisory Board in a matter of weeks. The use of the four words I referred to are not at all satisfactory and they should certainly be replaced by a more specific, definite period. Obviously, this would be longer in the case of phase 1 trials but for the other trials a period of 40 to 45 days would seem to be reasonable. Anything above that could cause problems. For obvious reasons, phase 1 trials would take a little longer and this I would accept. These delays can cause problems for companies engaged in clinical trials. They could cause them to move elsewhere, which would result in obvious job losses. Clearly, the growth of bureaucracy within the area of clinical trials will cause many problems and delays in reaching decisions regarding approval for a particular study.

It is vital that specific time limits be imposed and be specifically referred to in the Bill rather than the vagueness that is there at present. I cannot stress sufficiently the fear engendered by those four words. I want to stress that delays can cause havoc, that they can have serious implications for companies and, indeed, for persons engaged in clinical trials. We know that international markets rely on efficient and speedy decisions and delays and impaired efficiency could well force clients of companies engaged in this subject to relocate their custom in a more realistic, scientific and economic climate.

I should like to make a quick comment on subsection 3(iii) as it deals with refusal. May I assume that the Minister will give reasons for a refusal? This would be very important because for whatever reason a future Minister of Health might take a dislike to a person or persons or to a company who are undertaking this business. Without any reason, he might decide not to give approval and there appears to be no appeal procedure in the Bill. There is no redress. It is a matter entirely for the Minister to say yes or no. This lack of redress is somewhat unfair to the companies concerned and to the people who are engaged in this business. The Minister may revoke permission for a trial. How is this going to happen? It is well known that within the Department of Health there is not the necessary expertise to judge a complicated research protocol. How will the Minister or any future Minister or officials of the Minister's Department be able to monitor a trial in such a way as to determine that it is not being carried out in accordance with the actual permission? I cannot see within this Bill provision for Department inspectors or officials to monitor this work and thus come up with the conclusion that a trial permission should be revoked.

In section 6 in order to revoke permission the Minister ought to have some form of record available from an independent source or from his Department. Again, this is not provided for in the Bill. If there is no independent or departmental inspector to examine records, if the expertise is not available and there is no Department inspector to monitor the work, how is it proposed to come to the conclusion that a trial should cease? Obviously, a full definition is required and a full explanation.

The title of the Bill provides also for the setting up of an ethics committee, the major role of which is to be to consider the ethical or moral aspects of the proposed studies. The ethics committee's review and approval should be mandatory prior to the commencement of any study. In this way, it is possible to facilitate medical research in the interests of society and, indeed, to protect from possible harm the participating subjects — to preserve the subjects' rights and, to provide reassurance to the public that these objectives have been achieved. The committee must also ensure that the responsible investigator is appropriately experienced and has at his disposal facilities and staff to ensure that all aspects of work will be undertaken with utmost care and utmost consideration. Prior approval of research protocol by this committee is also necessary to protect investigators from possible comments — unjustified or otherwise — in the future.

The ethics committee must also concern themselves with the protection of vulnerable groups and avoidance of volunteer over-utilisation, to ensure that a minimum period elapses before they go from one trial to another. Obviously, the ethics committee should approve studies which would be of good scientific value and should not hesitate to make use of expertise where they think it necessary. We know that this committee will have the authority to reject an application on the grounds of inadequate scientific content or unnecessary risk to the participant. As it now stands, the approval of a protocol by the National Drugs Advisory Board is not in itself sufficient to permit a study to proceed. The power to make this decision lies with the ethics committee alone. Therefore, the ethics committee are a very powerful and important group, which need to be considered in great depth.

In section 7 (1) the Minister should have set out guidelines for an ethics committee which would have been helpful to them. This was an area where he could have got involved in assisting further the area of clinical trials. This would have been welcomed. People to whom I have talked over the past few months regarding this Bill, particularly the Social Policy Action Group, have very definite views on this and, indeed, other matters also. They are seeking an independent or ministerial appointed ethics committee. I am not sure that that would be practicable, or necessary. Having said that, I want to make it quite clear that I found the Social Policy Action Group extremely concerned but, unfortunately, for reasons which I will give, I could not see eye to eye with all their suggestions.

I know some of the members of the ethics committee of ELAN in Athlone. These include three medical practitioners, a World Health Organisation retired nurse, a Garda sergeant, a solicitor, a priest and a medical director. Of the committee in Dublin, I know of Mr. J.P. O'Riordan who is a retired national director of the National Transfusion Service Board and in my one meeting with him I found him to be an extremely responsible person. I also know a little about a Mr. Dunne who, I think, was a former Lord Mayor and was a public representative and there is also Mr. Ben Briscoe who is a Member of Dáil Éireann. All those are independent, responsible people who would not be influenced by any decision, but by their own consciences. We know that from time to time these committees have refused to approve of trials. We all know that Mr. Briscoe is an independent person who would not take chances, a man of integrity. He and his colleagues that I know will not take chances and will not cut corners. Why should they? They are answerable to their own consciences and any other attitude or frame of mind could not be appropriate.

It is not clear from section 7 (1) if the Minister intends to have a new ethics committee for each clinical trial. If this were the case, it would not be feasible. The call from the Social Policy Action Group for a totally independent ethics committee is not feasible either, for the reasons I have given. It is important that at all times there should be medical personnel on these committees, who would understand the medical wording. I find it somewhat unusual that under this Bill members of the ethics committee should be individually responsible for consideration of all the matters which are listed, some of which will certainly be beyond their own personal experience. In section 7 (2), the Minister seeks approval in this area also.

The primary purpose of the Bill must be the protection of participants, those who are engaged in clinical trials. This is the very kernel of the Bill. In practice, these investigations involve — certainly in the case of phase 1 trials and ones at ELAN — what are hoped to be healthy, young, male adults. Two factors are most important in regard to this area, first that they should be healthy and, secondly, that informed consent be freely available.

The defect in section 8 is that no provision is made to require full disclosure by the participant of his past medical treatment, or medical history. It is well known that, before a participant goes on one of these trials, he is medically examined from the start and right through the trial and in all cases, I would hope, non-disclosure of past treatment should be found out, but it is very difficult to legislate for emergencies. I have found, not just in this area but in areas generally, one makes the best rules in the world and they may not come out right. This aspect of the non-disclosure of vital information by a volunteer, is one of the single greatest problems in clinical trials, while every effort is made to find out the full extent of the medical background and past treatment. This could be very serious, indeed. The old insurance principle of uberrima fides, utmost good faith, could nearly apply in a case like this, not just from the volunteer to the investigator but the other way as well. Nonetheless, I think there is now a greater awareness of the full extent of the investigation. All aspects of the health and the treatment of the volunteers should be checked out and this is usually done.

Informed consent has been well defined. It is properly proceeded with before a trial is commenced. Informed consent is essential before any subject may be permitted to participate in a research study. The requirements for informed consent have been well and truly defined. The World Medical Association have indicated their stand in the Declaration of Helsinki and subsequent amendments to that. They say that in any research on human beings each potential subject must be adequately informed of the aims, the methods, the anticipated benefits, the potential hazards of the study and the discomfort it may entail; that he/she should be informed and he/she is at liberty to abstain from participation in the study and that he/she is free to withdraw his/her consent to participation at any time. The physician should then obtain the subject's freely given informed consent, preferably in writing. That Declaration of Helsinki uses simple and practical language which everybody can understand.

The American counterpart, the Food and Drug Administration say: that legally effective, informed consent must be obtained, either from the subject or his legally authorised representative, prior to recruitment into any research study. Consent must be obtained under circumstances that allow sufficient time for the subject to consider whether or not to participate and to minimise the possibility of coercion or undue influence. Information must be given in language comprehensible to the subject. Again, that is very simple, practical language, not the heavy medical phrases that might be used. Everybody can understand exactly what is meant.

Informed consent is, and must be, basic to any trial. As part of getting a better understanding of this Bill, I arranged to call to both ELAN and the ICP, on my own, independent of the staff, to talk to the volunteers, to see what they had to say and to talk to them freely about different aspects of the trial. I cannot help feeling that this facility would be available to any other interested persons or groups. They should be able to go out and talk to people in this way, too. Most of the people I met on these trials were young healthy men. I would have to say — and I was on my own — that they understood the trial fully, they knew of the side effects, of their rights and what the trial was about. One trial involved arthritis and another was for a heart condition. They knew of the matter of consent, of the aims, of the benefits and they knew that they could come off the trial at any time, if they so wished.

All these healthy young men would admit that the financial reward was the single most important factor for them. Yes, of course, they were happy that they were playing a role in medical research, but I would have to say that the cheque at the end of the trial — whether it was to pay an electricity bill, arrears of rent or for a piece of extra furniture — was the single most important factor. Most of these people were not at work; they were in receipt of social welfare payments. Some were on low wages, some were on holidays. One or two wer Army personnel who had three weeks holidays and decided to spend four or five nights doing a trial and getting paid for it. I know many of these people, they come to me at my house as a public representative in Athlone.

It is very important that the person be capable of totally comprehending the full nature of the trial. People who are of a very low IQ should be excluded from these trials. Perhaps a register of volunteers might be prepared so that it could be circulated. That might help in some way. Without doubt, to the volunteer the reward or recompense was the attraction.

Paragraph 7.4 (h) of the functions of the ethics committee makes the point that they should be satisfied that the reward is appropriate and realistic. In a perfect society, payment or reward might not be necessary. It should not be necessary in a perfect society but, unfortunately, we are not living in a perfect society. Ideally all those who volunteer should do so in the knowledge that they are helping old and sick people to get better. Whilst that knowledge came across in some way, I stress that the kind of money received was the principal criterion for most, if not all, to whom I spoke. Any attempt to restrict volunteer remuneration to unrealistic, low levels will positively result in widespread non-participation and probably the eventual termination of all essential studies. I would love to think that these people would go there for £25 or £31 a week, but I have no doubt that this suggestion would positively end the trials that now take place.

The very concerned social policy action group suggested a figure that would not exceed the supplementary welfare allowance. I would love to think that could happen and since my meeting with them I went out of my way to meet many of the young men who go on these trials. Every one of them made it quite clear that they would not spend four or five nights a week or five days a week away from their families or sweethearts for that kind of money. On the other hand, the rewards cannot — or should not — be pitched too high because caution might be thrown to the winds by some volunteers in an effort to get on a trial at any cost. Clearly this might increase the risk factor. To put it another way, the high recompense would reduce the value of informed consent freely given.

Section 9 of the Bill deals with the question of insurance of volunteers and states that this should 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. The concept of no-fault insurance is quite unfair and, indeed, unacceptable because if the product tested conforms to all required standards and if no negligence occurs in its administration to a volunteer, or in its prior assessment or subsequent care, then it cannot be accepted that there is any liability on the part of those conducting the clinical trial. A volunteer agreeing to enter a trial, accepting a recompense for so doing, having been fully briefed on the risks of any discomfort involved and the possible side effects of the trial, should be entitled to compensation only if the product under test is shown to be defective or if the conduct of the study has been improper. The Bill is seeking to ensure that no-fault insurance will be available here. If it was available it would command huge insurance premiums and would effectively put an end to clinical trials here.

An informal inquiry was made from the Department of Industry and Commerce to the Irish Insurance Federation to find out if this cover was available and they were informed that it was probably not available. Yet it appears in the Bill as if it were freely available. The consequences of that section could create problems for research in the future.

I got in touch with the Irish Insurance Federation and they said with regard to availability of cover for this risk, that initial investigations indicated that there is a very limited market for this type of insurance. They indicated that certain bodies who carry out clinical trials hold insurance which provides the organisation with cover up to an agreed level of indemnity for personal injury claims made against them. This cover is of a very restricted nature and normally excludes indemnity for medical malpractice by the doctor or consultant.

It is very difficult to be precise in regard to costs. It is normal for a policy of insurance like this to have a claims excess in the region of £10,000 or £50,000 with the higher excess reducing the insurance premium. There is an element of vagueness about the whole area of insurance in the Bill. The word "adequate" is not defined. It certainly is not precise. I saw an insurance policy, a kind of group volunteer policy, giving cover up to £10,000 for capital benefits, at a huge premium. However, a figure of £10,000 almost certainly would not satisfy the "adequate" clause attached to this policy. "Adequate" for a single unemployed volunteer might well be £10,000 or £25,000 but for a married volunteer with a large family, employed or unemployed, it might be ten times that figure. A clear definition and more thought must be given to this section. I mentioned what "adequate" is in two cases. If a volunteer suffers brain damage in a trial and becomes a vegetable, what is "adequate" in that case? A sum of £10,000 or £50,000 would not be adequate.

We are all aware that the insurance industry is in a chaotic state at the moment, particularly in regard to liabilities. Joint committees of this House discussed different aspects of insurance in regard to small shopkeepers or large builders. The kind of cover now sought in the Bill will not be available and will cause great harm to this industry. An article on medical negligence in the Irish Insurance Brokers publication makes the point that negligence has been defined as the omission to do something which any reasonable man, guided upon the considerations which ordinarily regulate the conduct of human affairs would do, or doing something which a prudent or reasonable man would not do.

This basic formula has been accepted for over 100 years but we are now changing the rules. It can be said that a clinical trial is, indeed, a medical matter. Medical negligence involves a breach by a medical man of his duty, of care owed by him to his patient or, in the case of clinical trials, to the volunteer. This section will certainly cause problems. I am not sure that this kind of premium or cover will be available, which is far more worrying. Somebody told me in England that an ex gratia payment might be inserted in the Bill. That would be an out of grace payment, which might be preferable to the “no-fault” position obtaining at the moment. As it stands, failure to get the required adequate cover will effectively end trials in medical schools, hospitals, health boards and universities. Section 9 states that before a clinical trial can go ahead that the Minister must be supplied with a copy of the policy of insurance.

What about research, for example, to improve the care of the dying? What about an insurance policy in that area? Patients with terminal cancer, obviously with a limited life span, are used in trials. In the knowledge that before this trial can commence the Minister must see a copy of the policy, does he really think that before this trial commences the policy can be produced to him? Cover like that would never be received.

Section 10 (b) states:

upon becoming aware of or suspecting any adverse reaction affecting a participant as a consequence of the trial being conducted, forthwith report that fact to the Minister.

This needs more clarification. I spoke to many volunteers — perhaps as many as 25 at different times — who were on trials. They were aware of the side effects. The requirement to report any adverse side effects to the Minister is not practical. The lads I met on those trials were told well in advance that they might get a headache or a dizzy spell. It will be very difficult to report every side effect to the Minister. Is the Minister talking about the side effects known to take place during a particular trial?

Section 12 (2) (a) states:

Subject to paragraph (b), where an offence under subsection (1) is committed by a body corporate, every person who at the time of the commission of the offence was a director, manager, secretary or other officer of the body corporate shall, as well as the body corporate, be guilty of an offence under this section and shall be liable to be proceeded against and punished accordingly.

That is an unacceptable paragraph. Why not include the janitor, the hall porter or other people? A clearer definition is required of "manager" in that section. Does it mean "general manager", "sales manager" or "stores manager"? Who is the secretary? Is it the secretary to the managing director or the secretary to someone else? Does an officer of the body corporate mean a laboratory technician or a pharmacist? The whole section seems extremely vague and needs a clear and positive definition.

The National Drugs Advisory Board are not mentioned in the Bill. The Minister is taking unusual powers for himself in this complex clinical area. Clearance of a clinical trial involves ethics committee approval and National Drugs Advisory Board approval. One individual will not have the power to grant or revoke permission for a clinical trial as we now understand it. To do so would involve an individual in responsibility for the study. In this section of the Bill it seems that the Minister for Health is taking such responsibility by virtue of his absolute power within the Bill. In the event of an accident, because the Minister seeks to take absolute power to himself obviously then he must live with the legal consequences which could follow. I have no doubt that because the Minister is taking unto himself so much power, if something did go wrong he could be cited as a codefendant. This section could also frighten off voluntary, independent, well-meaning people from acting on ethics committees in the future. The section, by implication, sets out to incriminate too many well-intentioned people. Certainly I visualise the legal people making a meal out of this section if anything goes wrong although, naturally, we all hope nothing will ever go wrong.

Section 13 seems to reverse the usual legal understanding that a person is innocent until proven guilty.

Section 15 deals with fees payable in respect of applications made under the proposed Act as well as other charges considered appropriate by the Minister for Health. It is stated that these fees shall be paid into or disposed of for the benefit of the Exchequer in accordance with the directions of the Minister of Finance. While it is stated in the Explanatory Memorandum that it is intended that the level of fees and charges will be such as to cover the cost of this statutory scheme, it is not stated that the level will not cover this particular cost. There is much concern about this section. We all know what happened with the Youth Employment Agency — moneys that were intended for specific use went into other areas of Government. You could argue that this is a blank cheque to the Government in this area of concern. The formula for deciding the fee to be charged is not mentioned in the section. There is vagueness about this and a fear as to who will decide on the level of fees. There is a debate going on in regard to the size of the fee, will it be £100 or £1,000? At what stage of the proceedings will this information emerge? Will we have more bureaucratic delays? The expertise does not seem to be available in Government Departments for this kind of work. I do not object to a fee but, provided the fees are not excessive, the big concern is that it will take weeks and weeks to decide on a fee. Who will decide a price for each trial? Certainly it needs further clarification.

The Minister in his Second Stage speech referred to consultation but from what I understand, very little worthwhile, round the table consultation took place. Did the Minister or his officials sit around the table with very important people who have the interest of this industry at heart? Did they criticise them or explain the problems as they saw them in this vital, complex matter? It is very important to have around the table consultation with such groups as the National Drugs Advisory Board, the Medical Research Council and many others who have a legitimate concern in regard to medical research and patients welfare. This consultation would have enhanced the Bill so that the very important objective of protecting the volunteers is achieved but in a climate in which much needed medical research can continue.

Our opposition to the Bill is quite strong. I stressed during the debate the importance of strict controls for volunteers. If the Minister had insisted on extra medicals before, during and after a trial we would support him. If he had asked for extra controls for ethics committees or subcommittees we would also support him. A number of things are wrong in the Bill. It is an all embracing Bill with an all embracing title beyond what was ever considered or dreamed about. There is an inadequate definition of the meaning of a clinical trial. There is the question of the absolute power the Minister for Health seeks in this difficult area. There is no mention of the National Drugs Advisory Board within the Bill itself. There are very serious problems in the area of insurance for universities, medical schools and groups like that as distinct from other corporate groups.

There is a lack of definition about fees and the resultant bureaucratic delays in the Bill. Major delays are inevitable, causing serious problems for the industry. The Bill seeks to treat all clinical trials in the same fashion. There has been a lack of formal consultation.

I hope we will not have a Committee Stage on this Bill because it is so wrong, so vague. There is a lack of consideration and understanding of the problems and knowledge of clinical trials.

I saw one ray of hope in the Minister's speech on the Health Estimate. He said that he would entertain all reasonable suggestions for improvements in the Bill. There is so much wrong with it that the Minister should consider not bringing it any further and prepare a Bill that everybody can accept. I hope the Minister will not proceed with this Bill and that he will have the necessary discussion with knowledgeable, concerned, interested groups and prepare a Bill that will not affect the future of medical research. This Bill as it stands will almost certainly do so.

I mentioned earlier that the Bill is very much out of line with legislation in other Western countries. I urge the Minister to introduce a Bill that will have the vital important objectives of protecting participants with the strongest controls in an environment in which much needed medical research can continue.

My contribution is provoked rather than being an ordinary response to legislation that is before this House. I qualify that by saying that if this Bill had been in operation 12 months ago, I would probably have been speaking from the point of view of someone who had lost a member of his family. Had it not been for the fact that drugs without restriction were available at all times to expert medical persons without delay, a member of my family would probably have died. It is for that reason that I forcibly express deep reservations about this Bill. From representations that have been made to me. I am firmly convinced that the Minister should have another look at the Bill. If he were to take on the task of redrafting this Bill, much of its content would be changed and many of the sections would be more direct. They would give a clear indication of the confidence of the Minister and the Department in the medical profession. Much of the correspondence that has been sent to Senators from all the various medical schools, colleges, universities and health boards has confused us to a certain degree. I have read it with great care and given it much consideration and underlying all of it is a deep opposition to this. It has been given coverage by all aspects of the media, but because it is a field where expertise and professionalism are necessary, there has not been much comment by lay people; it has been left to the professional people, to the experts in whom I have the utmost confidence to make that comment. Hence it is today that we Senators have volumes of material before us which we cannot treat lightly or dismiss. If we glibly dismiss some of the comments, we do so at our peril.

I say this at the outset because of my very strong personal feelings, while acknowledging that my understanding of the medical contents of the Bill is limited. But the general tone of the Bill is to assume that all medical research in new drugs is commissioned by multinationals and it is as a response to that that we have it before us. Indeed, the haste with which this was brought before the House is, I believe, a response to the very tragic death in 1984, of Niall Rush while taking part in a volunteer study in the Institute of Clinical Pharmacology. I appreciate the Minister's concern to bring forward legislation to control such studies. At the same time, it must be agreed that the fact that we have no statutory legislation does not necessarily mean we have no control. That is not the answer to it and that is not the response I would expect from any source. What I am saying is that in the National Drugs Advisory Board we have a competent organisation that down the years has shown itself to be expert in this field and has done a very good job on what it was intended to do. I believe the various Ministers through the years have appointed to that board people whose expertise in their particular fields cannot be questioned. We must give credit to the various Ministers for the quality and calibre of persons included on that board. But has the Minister available to him within his Department people of similar experience? The Minister may have people with certain qualifications in his Department, but what I am asking is if he has the personnel within his Department with the expertise to make the decisions heretofore made by the people on the National Drugs Advisory Board. I do not believe he has. I do not blame him for that because of the financial and other restrictions on him in these crucial times. In introducing the Bill the Minister is showing a lack of confidence in the National Drugs Advisory Board. I regret that very much because he has the opportunity to place on that board people with the expertise whom he himself can approach and ask to volunteer or whatever is the usual protocol with regard to appointments to that board.

The other aspect which frightens me is that it would appear from the volumes of correspondence all of us have had, that there has been no consultation. The Minister, in his Second Stage speech to this House, said there was consultation. But I ask him, can a simple request from the Department of the Minister of the day to respond by means of letters and papers be described as consultation? I believe it cannot and I believe that, as a result of that, the expertise and the goodwill that are abroad may be distanced at this stage from a very serious commitment to the Bill. Professional people cannot at all times give credence to any personal slants because their priority over anything else has always been the health and welfare of the people of this nation and it is to their eternal credit that we have a standard of medication in this country today to compare with other countries and with the level of financing in the Department that is a credit to them. There is no doubt about that. The level of financing for the health services in this country today compares very favourably with that in other developed countries. At the same time, whatever may have been the history and relationships of personalities in the past, I believe it is not too late for a new Minister, as Senator Fallon has said, to request consultation across the board. I believe that when all Senators have spoken, — and I would not like party politics to enter into this debate — the number of amendments which will be proposed to this Bill will render it such a changed Bill that the Minister should seriously consider withdrawing and redrafting it, having consulted with all the interested groups who now seem to have a legitimate concern but have not had an input, not simply because of their own personal egos but because of general concern for the welfare of our people and the development of medical attention for those requiring the services. The Minister should reconsider. I believe that the complaints which abound with regard to consultation are justified in the vast majority of cases.

The other aspect that concerns me is that the Bill vests total control in one person, the Minister of the day.

The Minister has a vital role to play in the whole proceedings. But I believe that the actual running of this aspect of control of drugs should be left with, if the Minister so decides, a revamped National Drugs Advisory Board with the people who are now absent from it incorporated into it and their experience availed of. But when whole systems become authoritarian not only is it difficult for the Department to administer them but it is even more difficult for the people involved, the practitioners and so on. If we are tied up in cumbersome technicalities and procedures I believe the tragedy we had in 1984 will be far surpassed by the numbers of tragedies that will be laid, rightly or wrongly, at the Minister's doorstep if people die, as inevitably they will, because of delays in procedure and protocol.

The Minister wants to take total responsibility for the trials of all drugs. Here, I come to one of the other problems I have with this legislation. Included in the legislation are all drugs, not necessarily new drugs that have to be tried before going on commercial sale and being made available to the practitioners. The fact that the Minister has incorporated ordinary everyday drugs makes it ever so much more cumbersome and there is widespread concern that the Minister has done that rather than sending the new drugs for clinical trial. I ask the Minister to seriously consider that and I look forward with hope. I know the Minister has responded very favourably to criticism in the past and is open to amending legislation. I hope that when concluding on Second Stage, the Minister will consider the wisdom of including everyday drugs already proven and shown to be effective. I hope he will omit that particular clause and include new drugs for trial.

Tied up with that is the fact that the Minister will have the power, without appeal to refuse or approve, naturally enough on taking advice available from within the Department. But at the same time he has that sole right without appeal and that is an unnecessary inclusion in the Bill. It is taking on far too much and it is unnecessary. I do not believe it is acceptable to the general body of medical people and I do not think the public at large expect the Minister to go that far. All of us realise that, no matter what regulations, or what committees, or what safeguards exist, drug testing is liable to go wrong on some occasions; it is not 100 per cent effective and safe in all cases. The paramount concern is that the patients' welfare must be safeguarded always. With that as the background we have an inbuilt safeguard without interfering with the Bill as it is.

The only other major concern that I have is in regard to the subjects who undergo the trials, their recruitment and, as Senator Fallon mentioned, the monetary compensation or reward that is given to them following the trial. Much of the media attention has homed in on this aspect. We have seen programmes on television and have seen articles by various sections of the media about the findings resulting from the unfortunate tragedy that we have had. In the greatest proportion of cases we see that most often the subjects are young people, very often unemployed and, even more often, homeless. It is a vulnerable section of society that comes forward. That is a general classification of the group. As Senator Fallon said immediately prior to me, the overriding factor seems to be the monetary aspect; in so far as the type of subject coming forward is concerned, the reward is the dominating influence.

It is important that the Minister has included in the Bill certain provisions which will bring these trials under scrutiny. But what is in the Bill is too vague. The recommendations of various groups that the reward would be below the supplementary welfare allowance for any person is welcome but therein is another problem: many of the participants need the money because they have no other source of finance; they have to get money some place and they do this rather than break the law. In many other cases still it is used as a supplement for incomes. As Senator Fallon said it might be an added bonus in a household or for a particular item of clothing or food. The people who present themselves are very often vulnerable people in society and as such are unsuitable for trials. There is, as the provisions of the Bill provide, the necessity for some screening prior to accepting subjects. The Minister's demands there are reasonable. That that has to be done by a general practitioner before the trial is undertaken is very welcome. That area of vagueness that might have existed in some people's minds before is clarified and there will be no misunderstanding as to the quality of persons undertaking those trials. To tackle it simply in the light of the social background and standing of that person in society would be difficult and it would be difficult to be absolutely confident as to the reward to be given in particular instances.

It is regrettable, as Senator Fallon said previously, that clinical trials and the advance of medical science in this country are given over to inducements. It is sad but real. Indeed, some of the multinational companies mention in their literature the contribution they have made by way of inducements to subjects to participate in clinical trials. That is a dangerous area. The ethics committee play a central role in overseeing the conduct of researchers. The major role of the committee is to consider the ethical and moral aspects of the proposed studies. The committee's review and approval should be mandatory prior to the start of any study. That is an aspect that all the people who have read the Bill should welcome.

The new requirement for a person wishing to arrange for the conduct of a clinical trial to supply particulars and get prior approval will undoubtedly lead to a cumbersome and costly operation. The Minister, as Minister for Health, will always be conscious of costs. But the Minister should reconsider his introduction in this Bill of an unnecessary additional cost into a simple procedure that has worked well in the past by way of the work of the Drugs Advisory Board. To conclude, I would, on Committee Stage have to bring forward a number of amendments which I see as absolutely necessary, and I am sure that all the other Senators, and many of the professional people directly involved with many aspects of this Bill, will have many other amendments to suggest too. This will render the Bill unworkable as it is drafted at present. I look forward to the Minister's comments at the end of Second Stage as to the final outcome of this Bill. Will he, in the light of the response that it has got, consider redrafting it or will it be possible to include the necessary amendments to make the Bill effective? Many people might say that a simple money Bill might have been sufficient to prevent the original reaction in so far as that would have been sufficient. If the Minister had limited that, would he have excluded by that simple method, many of the problems that could have arisen in the past? I await the Minister's response on Second Stage. Go raibh maith agat.

I welcome the introduction of a Bill in this area because it is important that we have adequate controls and proper protection of the public. I have listened with considerable interest to the contributions of Senator Sean Fallon and Senator Ulick Burke and they seem to be agreed in their approach. They both think the Minister should withdraw the Bill because they believe that it has a number of defects. The Bill needs considerable amendment and improvement, but I do not urge the Minister to withdraw it. Rather I intend and hope that the Minister will adopt the approach which he has indicated that he is open to discussion of and acceptance of amendments which would improve the scope and the shape of the Bill. That is what we would do on Committee Stage.

I listened with great attention to what Senator Fallon and Senator Burke said about the Bill. They both seemed to agree that we need a Bill dealing with this area. Neither of them said we did not; indeed they both for various reasons urged the importance of having a Bill to deal with the principle of proper protection and adequate and balanced control in this area. We have a Bill before us and many of us would welcome the fact that the Bill has been introduced into the Seanad. Now we have a constructive role to play; we have a task before us of ensuring that when the Bill has completed its passage through the Seanad it will reflect the proper concerns both of the medical profession and of other interests who have made representations to Senators, that the Bill will be a much better Bill.

I see nothing wrong with that. I see nothing wrong with the Bill being substantially amended during its passage through the Seanad but I would greatly regret any hesitation on the part of the Minister with his commitment to this Bill or indeed that he would in anyway listen to those who urge that it might be withdrawn, because if a Bill of this kind is withdrawn it will lose any parliamentary pecking order it has; it will lose momentum and it is much less likely that we will see any legislation introducing proper controls in this area.

Therefore, from the Independent benches I urge the Minister to stand firm but I will be seeking with others to impress upon him the strong grounds that there are for quite substantial amendment of and hopefully improvement of the structure of the Bill as it stands.

I had been made aware personally for some time before the tragic death of Niall Rush of a very serious problem in this area, a problem concerning volunteers participating in clinical drug trials. A number of social workers who are involved in the inner city area in Dublin had drawn the problem to my attention, indeed had in a general way sought legal advice as to whether any steps could be taken to protect what is very often a vulnerable group, as has already been mentioned, the unemployed, those who may already be using drugs, those who are disposed to participate purely because they need the money often for the basic amenities of life, often to pay for basic food and shelter. What was emphasised to me at the time, and what I feel is a very real cause for concern, is that a number of these very often young volunteers were used over and over again in these drug trials and that there was no adequate supervision, no adequate monitoring and no care taken, in some instances, to ensure that the drugs being administered as would be required for the purposes of the particular trial. We have a very serious problem and we must address that problem.

The detail of the administration and the shape of the Bill is a matter for Committee Stage and if we are agreed, as I feel the House will be, about the principle of the Bill then it is extremely important that we take time to consider the serious representations which have been made on various sides to Senators, and to the Minister, about the possibility of improving the Bill.

I wish to refer to the representations I have received as a Member of this House and I am sure a number of the representations I will refer to have also been received by other Senators. These representations are informed and they raise issues which merit extremely serious consideration. I am supportive of a number of the points made and I hope either to table appropriate amendments or, better still, to welcome ministerial amendments reflecting the acceptance of the points that are being made.

I will name my sources because it is important in considering representations about a Bill of this kind that it be known what the source of the particular criticism or the particular comment is. It is like a declaration of interest; we should know who is saying it so that we may weigh what is being said.

The first set of representations I want to consider comes from the Federated Dublin Voluntary Hospitals/St. James' Hospital Research Ethics Committee. They were prepared by Professor John Feely and by my colleague in the law school, William Duncan, senior lecturer in law and contain a number of specific comments about the Bill which I want to put before the House and comment on. First, under the heading "The Position of Ethics Committees under the Bill" they say:

Procedures for the approval of Ethics Committees within the scheme of control proposed in the Bill are unsatisfactory. Some of the rules appear to be based on an erroneous assumption that Ethics Committees are ad hoc bodies constituted to approve particular clinical trial proposals. The procedures are likely to give rise to excessive delays and involve giving the person proposing a clinical trial an improper degree of influence over the membership of Ethics Committees.

They go on to raise a number of specific objections which I will come to. There is a certain point in that initial overall comment. Reading the Bill as it stands it does seem to characterise ethics committees as being ad hoc. Indeed, the applicant for the trial seems to have a very substantial role in relation to proposing and, in the Bill as it stands, to objecting to a member or members of the ethics committee. That is something that warrants serious consideration. As the Minister is aware, ethics committees function at the moment and they function in a different way. We should examine how they function before we approach the whole concept of ethics committees in a quite different way which is what the Bill is proposing to do. Ethics committees, such as this particular committee, the FDVH/St. James' Hospital Research Ethics Committee, or the St. Vincent's Ethics Committee, or the Mater Ethics Committee, or committees in any of our major hospitals function as bodies whose members generally serve for about three years on the ethics committee. They are representative of different interests, medical, non-medical, both sexes and a broader desire to be representative of the wider public interest.

The advantage of a body that has members serving on it for a number of years is that it builds up its own expertise and evaluation over time. It would seem that this is preferable to having in all cases an ad hoc body in relation to each clinical trial which is proposed. I tend to share the construction put on the Bill in that at the moment it does seem that for each clinical trial there has to be prior approval of an ad hoc ethics committee which is the committee for that proposed clinical trial. In his reply to the Second Stage debate the Minister may wish to clarify that particular aspect.

I will come now to some of the specific comments or points made about the role of ethics committees as proposed in the Bill. A question is asked as to why it should be the applicant who, in all cases, would propose the names, qualifications and so on of the members of the appropriate ethics committees as in section 2 (1). I question that. That does not seem to me to be the appropriate role and relationship between an applicant body or an applicant individual proposing to carry out a clinical trial and actually proposing the members of the ethics committee. I see much greater merit in the existing system where there is a standing ethics committee quite independent of who would come along at any point and apply to carry out a clinical trial. On the face of it that seems to be a question which the Minister should respond to. Why give the applicant any role in proposing the names and qualifications of the membership of the proposed ethics committee? Should not that committee be already there in situ quite independently?

Another comment made is that the Minister will have to give prior approval to a proposed ethics committee no matter how frequently he may have approved that ethics committee before. This is another aspect of this question, of whether, as it appears to be proposed in the Bill, ethics committees have to be ad hoc bodies or whether it could be, as the existing practice is, that these would be bodies which would serve for a period of time. It would be proper and reasonable that the Minister would approve the composition of an ethics committee but that that ethics committee would have a certain duration and during that time deal with the clinical trial applications which came before them in the normal way. The research committee of the FDVH St. James' point out the delay and bureaucracy involved in having to clear an ad hoc ethics committee for each proposal for a clinical trial. That is a valid comment and I would like to hear the Minister's view on it.

Another criticism which they make, and which I share at this stage, is that the Bill provides that a person arranging to conduct a clinical trial can request a change in the composition of the ethics committee. That seems to be the wrong relationship between the person carrying out the clinical trial and the ethics committee. Why should they be able to recommend a change in the ethics committee? That would seem to undermine the independence, impartiality and distance between the ethics committee and the person proposing to carry out the clinical trial.

The last specific point on the ethics committees made in this representation concerns the fact that although there is mention of the broad concept of competence of members of ethics committees, the Bill is curiously silent about membership of and representation of such committees. It may be that the Minister did not feel it appropriate to write in provisions in any detail and in that way seek to standardise the composition of ethics committees, but it might be helpful to have some guidelines and standards in that regard.

As the Minister is aware, the Royal College of Physicians of Ireland issued a report in January 1986 on the use of drugs in biomedical research and appendix B to that report considers the whole question of ethics committees. It first of all considers what the objectives of an ethics committee should be and it also considers the kind of composition of an ethics committee which would be viewed as being balanced and rounded and reflecting what should be in mind. I should like to quote the two passages, first of all on the objectives of ethics committees and then on the kind of composition which these ethics committees should have. On the objectives of ethics committees the report recites as follows:

The objectives are as stated earlier to facilitate medical research in the interests of society, to protect subjects participating in research from possible harm, to preserve their rights, and to provide reassurance to the public that this is being done. Committees also protect research workers from unjustified attack. The Ethics Committee should consider the following points:

(a) Is the intention of the research to increase the understanding of some of the fundamental aspects of human structure or function in disease, or in health, or to test the effectiveness of various forms of diagnostic technique or the prevention or treatment of disease?

(b) May the required information be obtained from animal models and has the study been designed with a view to obtaining this information from as few subjects as possible who will be exposed to a minimum of risk and inconvenience?

(c) Is the responsible investigator appropriately qualified and experienced, commanding facilities to ensure that all aspects of the work will be undertaken with due discretion and precaution to protect the safety of the subjects?

(d) Has every effort been made to inform prospective subjects of the objectives and consequences of their involvement, and particularly of identifiable risks and inconvenience?

Ethics Committees should only approve studies which are of good quality and should feel free to refuse an application on grounds of inadequate scientific quality. They should not hesitate to make use of external advisers for difficult and technical problems.

The other area I want to refer to is the membership and appointment of ethics committees. On the question of membership the report proposes:

Membership should comprise at least:— (a) Medical, both those occupied chiefly with clinical care as well as experienced clinical investigators.

(b) Para-medical: a nurse who is in active practice with patients or other non-medical professional health care workers, e.g. physiotherapist, social worker.

(c) Lay: i.e. one, or perhaps, better, two persons not trained in or practising any medical or paramedical discipline.

(d) Both sexes should be represented.

I will come back to the question of membership when I deal with some of the other representations but it is important that we are aware of the kind of role and composition which would fit the role for an ethics committee.

The other issue which is dealt with in this representation concerns the review of applications. As I understand it the present approach in most cases where there are standing ethics committees in the larger hospitals is that if an application is made and is refused then the person who has been refused can, and very often does, reapply. There may be some slight modification but at least they can apply again to the same ethics committee and, if they are refused again, that is it. The ethics committees at the moment work under the National Drugs Advisory Board guidelines and, as has been mentioned by Senators Fallon and Burke, the board play a valuable role in relation to advising on and being supportive of the work of ethics committees. As I see it, and I do not claim to be a total expert in this area, it does not seem to me that the National Drugs Advisory Board are an ethics committee or are a potential review ethics committee. They have a particular role and expertise in relation to advising on drugs and, therefore, between the alternative of the structure proposed in the Bill, it is the Minister who will be the reviewing person or an official in his Department or the National Drugs Advisory Board. It does not seem to me that either of those represents the best approach to this problem.

I would not be of the view that this type of review or appeal of a refusal by an ethics committee should be to an official of the Department of Health. I do not think it is fair on an official to presume that they would have the knowledge, the sensitivity or the evaluation that an ethics committee would have. How could an individual have knowledge in different areas? This is a highly specialised field and it does not seem to be a proper approach. I understand that in Scandanavia they have addressed this problem by establishing a national ethics committee which acts as an appeal body from local ethics committees in hospitals and so on. I would ask the Minister to consider the possibility of establishing a national ethics committee which could act as an ethics committee for small institutions or private institutions which would not have easily within their reach or available to them a broad based ethics committee which could be established. They could use a national ethics committee which could also be the appeal or review body from the refusal of a standing ethics committee in one of the larger hospitals or other bodies which have standing committees. That would seem to be a way of ensuring that the public interest is safeguarded. I am strongly concerned about the public interest. The Minister should be directly represented on the national ethics committee. There is a public interest which the Minister has to ensure is safeguarded.

I do not see the value of internalising and centralising this into the Department of Health as is proposed in the Bill. The way in which that would function is not spelled out in the Bill. There is no criteria for saying how that process of review will operate. It is clear that this is something we will have to come back to.

The third point made in this representation is in relation to the scope of the Bill, something which has already been commented on by Senators Fallon and Burke. The view is that the scope of the Bill is too broad. The report states:

Ministerial approval will be required for all studies involving any "substance" or "preparation". In our interpretation this may include studies of dietary manipulation involving normal dietary constituents and even water. Furthermore, the inclusion of established drugs, those that are licensed for sale in the Republic of Ireland, is seriously out of line with legislation in this regard in Europe and North America and will, we feel, place unnecessary bureaucratic obstacles in the way of normal research and academic activities. Thus the taking of simple drugs such as aspirin by patients or by students in their practical classes will require to go through the lengthy bureaucratic and possibly expensive process of receiving Ministerial approval. Currently such studies are considered by an appropriately constituted, competent ethics committee.

The concern expressed here relates to the drafting of section 5 (2) of the Bill as it stands. Having looked through the section I am concerned that it is very broadly couched. Initially it is not intended to interfere with the normal practice of, for example, a registered medical practitioner or a registered dentist in a dental practice but the last words of section 5 (2) state that there should be no exclusion if it is not exclusively for the welfare of the patient. That wording gives rise to concern because that means a general practitioner — and hopefully more and more practitioners are doing this — who carried out ongoing empirical research on his patients in the sense of noting the effects of drugs etc., is not doing it exclusively for the welfare of the patient. That wording can legitimately give rise to concern. Perhaps Senator Robb can give us the benefit of his experience on whether this is a greater worry than we need have or whether, in fact, it would cause concern to medical practitioners.

The fourth point made in this representation relates to the status of placebo and non-therapeutic research and this relates to the interpretation of section 8 of the Bill as it stands. The concern is that it might not be possible to perform these kinds of studies using inert substances, or harmless substances for the purpose of monitoring the effects of drugs. These may not be possible and yet these placebo controlled studies are in many instances the only means of assessing the true efficacy of the particular therapy. That is another matter which the Minister should comment on in his reply.

One concern that has been expressed very forcibly to me is that this type of testing is standard for drugs that have been licensed for use here and that, therefore, it could lead to a fairly absurd situation where the Bill would prohibit the tests necessary to have drugs registered here.

A fifth major point raised in these representations related to the question of insurance. I am as concerned about representations from the medical profession about insurance as I would be concerned if I had representations from the legal profession about some matter related to their position. Therefore, I tread very warily when I am told that the provision in relation to insurance, as framed at present in the Bill, would be quite impracticable and not possible. Nonetheless, it was a matter of some concern to me to learn that insurance as a general rule is not carried by doctors practising in Ireland, that they would have malpractice indemnity, but that would be the height of it, that it would be — and I think there is some argument here— extremely difficult to get insurance on terminally ill patients in relation to clinical drug trials for the very reason that obviously the insurance risks would be too high. These are important issues which the Minister must address in his reply. It is not an area on which I have very strong or already formed views but it obviously is a matter which is causing concern.

The final matter raised in this representation from the FDVH St. James' Hospital Research and Ethics Committee is the whole question of bureaucracy, the fact that there is no time limit placed on the Minister's consideration of either the composition of the ethics committee or the result of its deliberations. The phrase, "The Minister shall as soon as practicable", is one of these elastic phrases that can run for weeks or even months and it may still be "as soon as practicable". The view is that this would potentially cause very serious problems and there are various ways in which it could be dealt with. A fixed time could be inserted, such as three or four weeks and if within that time no objection had been raised then the matter could go ahead. That would be one way of doing it and the onus, in effect, would be on whoever was the approving body to do so within a definite time.

I deliberately started with these representations because they cover a number of the points which are the areas which may and, indeed, in a number of instances will require amendment on Committee Stage. I hope when the Minister is replying to this debate he will take the time to address these issues and these areas and indicate what the ministerial response is to them.

Another representation which I received, and which I am sure other Senators received, was from the academic institutions, from the deans of the medical faculties in a number of institutions. It is not all that often that one has such unanimity in the profession, and there does appear to be a wide degree of unanimity on some of the major worries about the Bill. I will quote from this statement which is signed by a number of the deans of the faculty of medicine and representatives of the Royal College of Physicians and the faculties of medicine in Ireland. I quote:

We are particularly concerned at 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 (on the payment of a fee) for normal medical and dental student educational practical classes but also for studies involving simple dietary changes.

They go on to seek a distinction between drugs in routine clinical practice and new drugs. This is something that seems to be strongly emphasised by those who are informed and are aware of the need to draw a distinction between already licensed existing drugs and new drugs where much greater concern and much greater issues would require to be taken into account.

The other representation which I wanted to deal with is from a different source, not from the academic or medical side but from people on the ground who are closely aware of the problem I identified at the beginning of my contribution, that is, the representation of the Social Policy Action Group. Senator Fallon referred to a number of points which were made in the representations from this group but I would like to deal with some of them in considerable detail. They refer to the criteria in section 2(1) (d) of the Bill to be used for the selection of participants and say that this must take account of their medical and social background. It is worth reflecting on the type of volunteers who tend to be drawn into these clinical drug trials. They tend to be young, unemployed, short of money and socially deprived. Are they necessarily or even clinically the type of persons who would be likely to reflect the indications of problems of those who might be using the drugs? Those drugs might be used on geriatric patients. Is enough care being exercised? I am concerned that there is not. Vulnerable helpless volunteers who are inadequately informed are sucked into the system. They do it purely for the money and are exploited in some instances by those who are carrying out the research for the purpose of increasing the profitability of their enterprise. Therefore, the Social Policy Action Group are concerned that details of any proposed inducements or rewards, whether monetary or otherwise, should be made known. I understand that this is already a function exercised by existing ethics committees — certainly by the ethics committee with which I have been in contact. They require to know if monetary inducements are being handed out and, if so, the level of those monetary inducements and so on.

The Social Policy Action Group say that such payments should not exceed the rates as laid down for supplementary welfare allowances. I would like to reflect on that. They should be at a modest enough level not to be, in themselves, a strong inducement. I am not sure if it is necessary, at the same time, that they should be kept inflexibly to the level of social welfare allowance. It is more important to ensure that there is no exploitation. The social policy action group talk about the composition of the ethics committees and make the very valid point that those appointed to ethics committees must have no involvement, financial or otherwise, with the testing agency or any drug company. The Minister should be concerned to ensure that nobody with a financial stake in or no employee of a drug company would be a member of the ethics committee approving or considering a proposal for a clinical trial and that they would have no financial stake or financial involvement at all in the matter which they were examining.

The Social Policy Action Group refer to the composition of ethics committees and that has been dealt with in the report prepared by the Royal College of Physicians, a report from quite an in-house and rather conservative source. In relation to ethics committees, we should try to ensure that they actually represent in a broad way, in some measure at least, those who are likely to be the volunteers or certainly are likely to know of the problems on the ground. I strongly advocate that the membership of ethics committees should be of both sexes and that there should be substantial lay participation as well as medical participation.

The final point made by the Social Policy Action Group which we must consider on Committee Stage is the whole question of the informed consent, of the person being either capable or not of comprehending how they would consent. Their view is that where a person is incapable of comprehending the nature, significance and scope of a consent that person should not be a participant in a clinical trial.

They were the substantial representations I received on this issue. There were other representations which repeated some of the points I have made which were made to me in my capacity as a Senator, knowing that this Bill was introduced into the Seanad and that we would have the first opportunity — and I hope a very full opportunity — to consider it.

One matter which did not form any substantial part of the representations made to me and on which I would like to hear the views of the Minister is the extent to which there should be monitoring of the carrying out of clinical trials when they have been approved. As I understand it, in the United States they can provide for inspectors who have a right to go and see whatever they want to see in relation to the carrying out of a clinical trial. They can go in at any time. Under the World Health Organisation there is support for the idea that an inspectorial role should be played. I do not see that written in to the provisions of the Bill at this stage and I wonder if it should be included so that there is a right, which need not be exercised in a manner that is unduly intrusive, to inspect and look at books. The Bill provides that a report should be made and that information must be supplied by the person carrying out the clinical trial but it is important, given the nature of the matter and the significant need for the protection of the public, that there should be some form of right of inspection as such during the conduct of clinical trials. I would also like to see some method of follow-up on former volunteers, some way of ensuring that even if they did not suffer any ill-effects during the course of a clinical trial, that they have not, perhaps a year or six or seven years later, suffered indications that would be worrying and that might be attributable to their participation in a clinical trial. These are the main points which I want to deal with at this stage.

Finally, both Senator Fallon and Senator Burke criticised the lack of consultation before this Bill was introduced into this House. From what has been said to me in relation to various representations, I believe there probably was inadequate consultation. It would have been preferable if more time had been taken for consultation with various interested and informed parties. That is not a serious defect in a Bill of this kind if we now enter a flexible and constructive process of amending and improving the Bill. Now is the time when it would be very relevant to have consultation in relation to any proposed amendments so that proposed approaches to amendments can be discussed. Those who have considerable knowledge of the existing system, are aware of the difficulties, are aware and concerned about the need to further and foster research in Ireland should be involved, just as representatives and Members of this House would wish to be involved in considering amendments and in putting forward various detailed improvements to the Bill. I hope that we can have Committee Stage arranged on a timescale to allow full consideration of possible amendments and that there will be a process of consultation in the interim. I would then be confident that the Bill will emerge as an improved Bill dealing with a very important social area.

I have precisely five minutes because unfortunately I should be undertaking——

On a point of order, I proposed earlier today that we rise from 5.30 p.m. to 6.30 p.m. but as Senator Robb's professional duties impede him from being here on a Thursday, I suggest that we rise at the conclusion of his contribution or at 6 p.m. whichever is the earlier.


I am very grateful to the Leader of the House for giving me that amount of leeway. I will not keep the House too long, but it is important to throw into the debate the sum of my experience, particularly when I was working in academic surgery over ten years ago. I was very heartened to hear Senator Robinson's approach to this subject because, in supporting the thrust of the Bill — which I will also do — she requested the Minister to leave himself open to amendments. I am quite sure that this Bill, like so many others coming through this House, will be greatly improved by amending it.

I should like to start by holding up for the attention of the House a £10 cheque which I was sent in 1977 and unlike those from Seanad Éireann it has not been cashed. That £10 cheque was sent to me with an accompanying letter from a drug company saying that as promised, they had despatched to me free of charge 4×10 one ml. ampules of a particular drug, together with a supply of coded patient record cards, that these had been sent to the hospital pharmacy marked "for your attention" and that they had asked the pharmacist to let me know when they arrived. They went on that they had pleasure in enclosing a cheque for £10 in payment for my registration fee, and confirmed that for every ten completed patient cards received by them between then and 31 March, a further payment of £15 would be made to me.

That is inducement of the worst sort. No matter how well disciplined, no matter how professional we try to be, that is temptation handed to one on a plate. I was not subjected to any ethical committee, nor was there any suggestion that there should be an ethical committee, had I chosen to accept the cheque and get on with receiving the £10 notes in rapid order. The irony is that that drug has now turned out to be a very successful drug and is in wide use. Here, is the dilemma. How does one obtain the research in order to ensure that drugs are safe, and while one is doing this research, how can one ensure that the motives of the researcher and of those that are promoting the research are such as to ensure that the target of their research is going to have the research done on him safely? That is what we are discussing here.

In order to do some research in my much younger days — something I look back on now with some apprehension — I felt it would be useful to determine the value of pentegastral stimulation on the acid juice of children. The results had been well known in adults but this required the passage of a nasal gastric tube into the stomach, the injection of pentegastrene and over a period of an hour or two hours, the collection of the child's gastric juice. At that time, 16 or 17 years ago, this was not subjected to any harsh or stern scrutiny by a committee. As a result, I could speak to the parents, I could discuss what I was doing. Although it depends what emphasis one puts on it, it is very easy, as a professional dressed up in a white coat in a clinical situation where the dependent mother and nervous child comes with a longstanding problem, to persuade them that if this is not to their benefit it may be to the benefit of many children in the years to come, when in fact one knows, it is primarily of benefit to one's own research project, to one's own acquisition of papers in the whole business of what was known in the fifties and sixties when I was going through the research machine as a publish or perish mentality. There is another reason why we need to scrutinise what is going on when it comes to research on fellow human beings, be they fit or be they ill.

There is an increasing awareness among people, particularly among those who are earnestly pro-life in reaction to the pro-death nuclearism in which we find ourselves, of the quality of life of animals and they are much more insistent that standards of research and standards of experimentation on animals are under the most severe scrutiny. In another research I tried to develop an operative technique for people who suffer from portal hypertension as a result of liver cirrhosis, whereby one diverts the blood going to the liver into a vein which takes it on to the heart. This involved 50 to 100 greyhounds. Those greyhounds were subjected to at least three operations in the course of their lives and, as a result of this, had a deplorable existence. In any case I am mentioning animal research, investigatory research, and therapeutic research. I would very much support the general thrust of the Bill because we need to promote safeguards in relation to what is being done. Senator Mary Robinson's suggestion of standing ethics committees is an excellent one. The idea of a national ethics committee is also excellent.

Taking the point that has been raised this afternoon by Senators Fallon and Burke and also by Senator Rogers, we have also got to consider that if we are going to have effective research and if our research is to remain well motivated, and if we are looking for results which can be of benefit to the health of the people, then the people who are doing that research and who can stand over that type of research must not feel that they are lumbered with unnecessary bureaucracy and must not feel that they are applying for permission to remote Departments in which there is not the expertise or understanding to respond positively, quickly and constructively to their application.

I was rather alarmed that Senator Burke has such a tremendous faith in professionals. Certainly, professionals have their role to play. They have had a training and they are there to respond to specific social needs. But professionals are human beings like anyone else. When one looks at the pressures put on our young and not so young, men in the medical profession today in order to train themselves, to establish themselves, to meet the criteria of colleges, general medical councils, teaching hospitals, universities and so on, to churn out papers, to do higher research degrees, post graduate degrees, in order to get that thing they are all after, the ultimate job, then we must realise that, being human, they will endeavour to produce the goods in order to achieve what they want. Ask many of them, and they will say that their prime object is not the point of the research, but to do research in order to get where they want to go. I am not exaggerating, that is a general feeling. Look at the institutions; in order to get capital to keep them funded, in order to get the grants for staff and equipment, they must keep churning out the research material. It is vital that we have an up-to-date, responsive, effective and broad based means to scrutinise what is taking place in the name of research on human beings, and in particular on human beings who are not able to fend for themselves. Therefore, I support the general thrust of this Bill but, without going into detail because time is short. I hope we will have an opportunity to discuss it further when it comes to Committee Stage and that the Minister will be able to take on board many of the recommendations which I am sure will be made at that time.

Debate adjourned.
Sitting suspended at 5.40 p.m. and resumed at 6.30 p.m.