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.
