Deputy Browne. I have called Deputy Browne who was in possession, but he does not seem to be in the House so I am calling Deputy Flaherty.
Control of Clinical Trials Bill, 1986 [Seanad]: Second Stage (Resumed).
Question again proposed: "That the Bill be now read a Second Time."
I welcome the decision of the Minister to proceed with this legislation initiated by the previous Government. While accepting the need for substantial legislation in this area I have some criticisms of this Bill. The Bill as drafted could have an effect opposite to that indeed. The provision relating to the ethics committees and to insurance could drive research out of the hospitals and into the commercial private sector. This was the area which we hoped to control through this legislation. Research into some terminal illnesses and into cancer would have to cease as insurance is not available here for research into those areas to cover any compensation claims. Despite substantial amendment and improvement in the Seanad there are still major flaws in the Bill.
The conversation in the lobby is disrupting debate in the House. Deputy Flaherty, without interruption.
Section 3 (c) of the Bill requires the trialist, the person proposing the trial, to name the ethics committee for the trial. This is a recipe for chaos and it undermines the whole purpose of the Bill. It is totally unacceptable that the proposer with the major interest, often financial, is, in the conduct of the trial, to appoint an ethics committee. This approach by the Department is clearly as a result of their failure to consult adequately or to consult at all with the many professionals who have been voluntarily supervising the control of these trials for many years. A hospital could not accept a case where a trialist sets up his own committee. Indeed, the National Drugs Advisory Board would have to advise them against doing so. Ethics committees, to be of any use, must be independent. This will have to be looked at closely. I know the Minister has had discussions on this with some doctors in recent weeks and I would be interested to hear his comments.
The ethics committees are central to the Bill because they will supervise the trials and will impose all the restrictions we are anxious to see effectively imposed. Hence, any question about their independence would seriously undermine the whole thrust of the Bill which we support. There exist in all hospitals and in some independent institutions, ethics committees — who have developed expertise in this area over a period — made up of people from legal, medical and scientific backgrounds. The handling of clinical trials is obviously a specialised area which requires expertise. We have a very small pool of people qualified to handle the various ramifications. We have people who are experienced in this area and whose record stands for itself.
Some weeks ago I put a question to the Minister asking how many complaints or claims the Minister had as result of clinical trials and the answer was that there was none. That indicates that, within the health service, ethical committees have operated effectively to protect the public and yet have allowed medical developments to go ahead and research to take place. In amending this legislation the Minister should consider incorporating those existing structures, or improvements incorporating those structures into the Bill. He should lay down statutory guidelines for the make-up, appointment and dismissal of these committees and he should ensure that private institutions should be supervised by ethics committees from local health boards, not ethics committees appointed by the institutions or trialists.
There should be some form of accountability and supervision in these ethics committees. They will all have to be approved by the Minister but everybody will accept that the Department of Health has not the expertise and will reply on the National Drugs Advisory Board to provide it. The National Drugs Advisory Board have had a system in operation but it needs to be given statutory basis and it needs to be extended to cover the private institutions who will have to participate in this procedure from now on.
The current proposals are dangerously loose and could undermine the intent of the Bill. If there are 100 different ethics committees supervising work in hospitals and each has to be agreed by the National Drugs Advisory Board and the Minister, the net result is total chaos. In the area of clinical trials, speed is often of significance. The levels of delay that are possible because of the layers of bureaucracy suggested in the Bill are potentially destructive in the field of medical care and they should be re-examined.
Section 10 sets out the requirements for adequate insurance for compensation. On the surface it is a straightforward and worthy requirement and I support it. I gather the current practice is that substantially all clinical trials are covered by insurance and the National Drugs Advisory Board would have required that. However, it is not possible to get insurance for research into certain sensitive areas such as work with the terminally ill or with cancer patients. Since the publication of the Bill, Irish doctors have made inquiries and have found that cover will not be provided. Therefore, the net effect of this Bill is that research in our hospitals in these areas will cease.
A further problem arises from the cost of insurance when available. While drug companies and institutes will be able to pay these premiums, doctors within our universities and hospitals will not. Hence much needed research which is not commercially attractive to the private, profit-oriented organisations may not be done. For example, St. James's Hospital submitted 60 trials to the National Drugs Advisory Board last year alone. Some of those may have been funded by drugs companies, some would not. Some would have been taken because doctors in the field saw a need to advance work in this area. If they are required to have insurance which can be of the order of £10,000 a year for a premium for a trial, this would put it out of the reach of doctors in the medical service.
It is unfortunate that in drafting the Bill with the best intentions, it seems that we have hit at this area. Perhaps awareness of the level of research going on in our hospitals was insufficient. This issue must be resolved if we are not to exclude hospital consultants whose contracts require and encourage research to be substantially excluded from their work. I ask the Minister to respond to these points. He said he has had discussions with representatives of the senior doctors involved. I hope he will see a way to deal with this.
The solution may be found in the British approach whereby pharmaceutical companies agreed to pay compensation and the Department of Health and Social Security stated that they would make ex gratia payments to patients in their hospitals. The question I put to the Minister elicited the reply that he had no claims to date arising out of trials in hospitals and there is no reason to expect a change in that following this Bill. Similarly in Britain there have been very few claims indeed, and claims that have occurred recently in hospitals can be related to lack of informed consent. This should be examined because it would be a very unwelcome and totally unacceptable side effect in the health services.
The difficulties in drafting this legislation may be due to the fact that we are blazing a trail in control over clinical trials on volunteers. In legislative terms very few countries have statutory controls over this matter. Britain has no statutory controls over trials on volunteers but has controls under the medicines Act of trials on patients in hospitals. The need for controls is being examined there. Perhaps because we are leading the way in this area, and rightly so, we are having such difficulties in drafting the legislation because we have very little to work on initially. The Bill was amended and improved substantially in the Seanad and I hope the Minister will be open to amendments and that we can be helpful in developing and improving the Bill and removing the remaining defects which are quite significant, particularly in the two areas I have mentioned.
I congratulate all those involved in the Seanad debate for their contributions and their impact and I congratulate the former Minister on tackling the issue and making progress. I congratulate the present Minister on continuing that progress, but let me point out that consultation should have taken place with our drugs advisory board at an adequate level through his Department. We are not permitted to refer to officials but let me say that the officials there might have been wiser to have taken that road and to have relied on people they had appointed, and who have served well in this regard, to test this legislation. They could have pointed out many of the problems that had to be amended in the Seanad and will have to be amended here.
The purpose of the Bill is to protect participants, whether volunteers or patients, and to allow necessary and desirable medical research to proceed. I ask the Minister to respond to a point which was raised several times in the Seanad. Is it desirable for ministerial involvement in supervision to be as extensive as it is? Is it not simply adding another layer of bureaucracy which can have little or no impact on the security of the persons involved in the trial? Within his Department he has many talented people but their expertise is largely not specialised, not related to this area, and essentially he will be relying on the NDAB for advice in relation to any decisions he may have to make about trials. Would it not have been better to have appointed that body statutorily, increasing their powers and establishing on a statutory basis the ways in which they will have to supervise trials and the regulations under which they will have to operate? This would have been a better approach and, even at this stage, the Minister might reconsider the extent and perhaps the principle of the Department being involved in this way. The NDAB have not been given total statutory control over this area to date. They have had only a voluntary control.
I am concerned about the broadness of the definition in the Bill which states that the Bill is an Act to provide for control over the administration of one or more substances. This is a very broad definition and already amendments in the Seanad have led to a number of exclusions. The British Act refers to the administration of one or more medicinal products. Some more defined term in this Bill would result in fewer problems for those engaged in using medicines in the ordinary way in the care of people.
The sanctions in the Bill are inadequate. I should like the Minister to examine them, given the size of the business and the profits made. I know that one of the drug testing agencies have been in contact with the Minister about a problem they have about the terms of the definition in a section of the Bill and I will be interested to know whether he can meet the points they raised. The onus of proof——
Let me interrupt the Deputy. While there is no time limit on the speeches, I am sure the House will appreciate that I am obliged to call the Minister to reply not later than 8.30 p.m. and some other Members are anxious to participate. In the interests of equity and fair play I ask Deputies not to be unduly long to afford others an opportunity to intervene between now and 8.30 p.m.
Some of the Deputies who were seeking to speak took up 25 to 35 minutes of debating time by the carryover of another business and I sat here awaiting the opportunity to speak during those 35 minutes. However, I will conclude as quickly as I can because I know others are very anxious to contribute. The two points I made at the start are the ones I should like the Minister to address because they are the fundamental flaws in the legislation as it stands. He can return to the other issues.
We support entirely the initiative to bring in controls in this area. We believe that a good deal of progress has been made on the Bill but that further progress needs to be made.
I welcome the opportunity to speak on this Bill. The House will remember the tragic death some years ago of a young man in an institution in Dublin which caused a great deal of public alarm. I was sufficiently interested to go along to the institute at the invitation of many of the people working there to establish what was going on. As a result of that visit I was shown copies of the coroner's report which subsequently exonerated the institute completely from any responsibility in relation to the tragic death of that young man. He had not disclosed he was taking another drug which, unfortunately, interacted with the one being tested. There were four other volunteers on the same drug but they had no ill effects. As a result of that tragic incident the institute initiated a number of new tests on volunteers.
Subsequently I raised the matter at our local health committee. I informed them that the institute would be quite happy if the committee wanted to visit the institute and ask any questions of the clinical director. The committee did visit the institute, as a result of which the director of the institute invited the local health committee to nominate two members to serve on their ethics committee. At that time I was nominated by Deputy Tomás Mac Giolla and a former councillor, Councillor Paddy Dunne, was also nominated to serve on that committee. I found out something about ethics committees and their functions. As an ethics committee our function is not to become involved in the technical detail of any drug being administered but rather to satisfy ourselves that volunteers know there is always a certain risk involved in volunteering for drug testing and understand exactly what is being proposed to them.
The institute are very happy with the provisions of this Bill and are very glad its provisions have been tidied up. The punitive provisions of the original Bill were so as to have almost required the consent of the Minister for Health to authorise a doctor to give a patient a diet chart. Much ground has been covered since. As Deputy Flaherty said, much of the looseness was eliminated in the course of the Seanad debate.
I should say that serving on this ethics committee, among others, are a housewife and myself. I can assure the House that, as a public representative, I would not be serving on such an ethics committee if I thought there was any danger involved for volunteers. I am absolutely satisfied that the volunteers are found to be healthy, young people. There have been reports and speculation from time to time that old people, down-and-outs, and people in bad health were volunteering on the strength of inducements. There was much speculation about inducements. It would be wonderful if, as in the case of somebody in Army service — when an officer was given a couple of weeks off to undertake FCA training — people could be given a couple of weeks leave each year to volunteer for drug testing if they wanted to do so.
The safeguards are enormous. For example, no drug testing can take place in the institute unless sanctioned by the National Drugs Advisory Board. They are the people responsible for ascertaining whether a drug is toxic or whether it should be tested on a human being. The National Drugs Advisory Board need not cost this State one penny. The drug companies who want their drugs tested would be happy to pay whatever charge the National Drugs Advisory Board might levy in order to test their drugs on volunteers. At present the National Drugs Advisory Board is badly under-staffed, their personal grossly overworked. Because of the thousands of new drugs constantly being developed they are subjected to enormous pressure in sanctioning drugs for testing. Therefore, our attention should centre not so much on the Institute of Clinical Pharmacology as on the National Drugs Advisory Board. Their activities could be expanded extensively without any cost to the State because the drugs companies who invest millions of pounds in drug testing would be quite happy to meet whatever would be the requisite charge or fee. The Institute of Pharmacology would welcome that proposition.
I heard recently there are about 5,000 diseases in the world at present for which there are no cures. People who may be against the idea of human beings volunteering for drug testing, if they feel so strongly, should not even take an Aspirin for a headache. They should remember that every single tablet ever consumed has been tested on human beings. We hear much about the AIDS epidemic at present. Drugs will have to be tested on human beings until ultimately a cure is found. At present such testing takes place in the United States and on the victims of AIDS. Scientists are endeavouring to develop a vaccine but that may take a long time.
It should be remembered that our Institute of Pharmacology is at present a world leader in drugs testing. They have opened another institute in the United States which is proving to be very successful. There is sometimes an illusion created in people's minds that the Institute of Chemical Pharmacology are covering up something because of there being such huge sums of money in it for them in the testing of drugs. The reason for the existence of our institute, another in Huntington in England, another in the United States and in a number of other countries is that, after the great thalidomide tragedy drug companies were afraid of testing their drugs for fear of something going wrong. They wanted an independent, third party, to test their drugs. They will not risk their reputations by giving the go-ahead for a drug, contending that it is perfectly safe for human consumption, if they have any suspicion that it is not because they would then be in dire trouble. The large pharmaceutical companies will not allow themselves be accused of having put some drug on the market which they knew to be unsafe because there was big money to be made on it, such as happened in the case of the thalidomide drug, about which everybody knew. An independent institute such as ours is worth millions to this country and it is important that we understand that.
I have stressed the independence of the Institute of Clinical Pharmacology. Certainly they could do without a tragedy such as occurred in the case of the death of the young student which was occasioned not by the usage of the particular drug being tested but by the interaction between drugs. Prospective volunteers who come to the institute are screened for all sorts of complaints and diseases, for example, whether they have hepatitis, whether they are taking drugs of any type and what is the condition of their general health. If there is found to be anything wrong with them they are not accepted as volunteers. Part of my duty as a serving member of that ethics committee is to go in there and talk with volunteers. Some may have been there three or four times. We ensure that no volunteer offers himself for testing more than he should, that the blood taken for testing is found to be within certain limits, that they are not being subjected to any pain or suffering and that they understand fully what they are doing.
I want to refer again to the question of inducement. Why should they not be given some reward for this? They are doing something which is of great benefit to mankind. Many people have felt very hurt by this and that includes students who have been studying biochemistry in Trinity College. Incidentally, for the first time newspapers are now allowing advertisements to be put in the papers advertising for volunteers. This was something about which the newspapers had certain feelings but they are satisfied that it is perfectly ethical and quite safe so far as safety can be monitored. It is more dangerous for any of us driving home tonight than it is to go in as a volunteer to the Institute of Pharmacology. Those of us who are members of health boards are aware of the need for more generic drugs. Some of the big name drugs are very expensive but, of course, there are lower cost drugs also. This is one of the areas in which institutes of pharmacology are working. They are developing new drugs. They work with drug companies from France, Japan, the United States, Britain and many other countries from all over the world. They are trying to develop cheaper forms of the same type of drug which will have the same effect. That work must continue.
The Royal College of Physicians recently issued a book of recommendations which the institute follow. In the institute all drug testing and monitoring is based on a Helsinki agreement. It is a lengthy document. It stresses very carefully what can and what cannot be done where the testing of human volunteers is concerned. The Food, Drugs and Administration Acts of the United States are also used. It is good that we will have our own legislation and our own set of rules. It is well we have not thrown the baby out with the water, which we might have done in the original panic measure which was introduced to control the testing of drugs. It could have been very foolhardy and dangerous. I can assure the Members of this House that my experience on the ethics committee has given me the greatest confidence that the safety of the volunteers is carefully monitored and will continue to be monitored.
I stress on the Minister the importance of improving the National Drugs Advisory Board. Among the members of the ethics committee is a toxicologist — who is also on the National Drugs Advisory Board — as well as a Jesuit priest, a housewife, former Councillor Dunne and myself and a professor of biochemistry.
There is no testing on pregnant women. In fact, I do not think they will take in women for testing, or do they?
I know an old lady who was tested for arthritic drugs.
Do not confuse between doctors who are testing out drugs on old people in hospitals. It is not done in the institute itself because there are different types.
This old lady did it for the money.
There are drugs that can be good for old people but may be very dangerous for young people. One has to be very careful. The Institute of Pharmacology have not tested drugs on old people, no matter what Deputy Flaherty may intimate. I would like the Deputy to give me details, because I will certainly raise the matter at one of the meetings. Drugs are administered very carefully. There is a lot of work being done on arthritis and on Alzheimer's disease because as we all know they are looking for cures for this disease all over the world.
There is a great need to improve the existing drugs, because all drugs no matter what they are have side effects of some sort, and ultimately either the drug or the disease will kill you. The intention is that the drug one takes for a disease will prolong one's life and not shorten it. The objective of testing and developing new drugs is not only to eradicate and cure disease but to lessen their side-effects. I am not a doctor; I am a lay man who is conscious of what is happening in the Institute of Pharmacology and I am satisfied that the welfare of the volunteers is being very carefully monitored.
As Members of this House it is our duty to help and sponsor beneficial change in our society. It is recognised there has been more change in society over the past 100 years than in the previous history of mankind. It is also our duty and privilege to protect the weaker members of society from any form of exploitation, however well meaning that exploitation or its usage may be. The purpose of this Bill is to draw the balance between these two objectives. In making the following points I am trying to help this process and improve the Bill in its dual objective of promoting and allowing clinical trials and of protecting those who volunteer to take part in them.
This Bill is long overdue and I welcome it. The general thrust of the Bill is good. However, there are some matters in the Bill I would like to have clarified. The central prohibition in the Bill is to prevent the conducting of clinical trials unless certain conditions are met. Central to the conducting of a clinical trial is an investigation for the purpose of ascertaining the effect of the administration of one or more substances, where such administration may have a pharmacological or harmful effect. The definition of "administered" which is contained in section (1) is central to this. It appears this definition is confined to substances introduced to the body orally, by injection, in other ways or by external application. I feel there is a weakness in the Bill, as much of modern medicine is based on therapy, including psychotherapy, physiotherapy and manipulation in various forms. Indeed, much of psychiatry is therapy-orientated. All of these areas should and by their nature must be subject to experimentation. In my view this should be covered in the Bill. In other words, I would like the provisions enlarged to cover all sorts of genuine clinical trials and not those confined merely to the deduction of substances.
My second point arises out of that matter. The conducting of a clinical trial is limited to a medical practitioner or a registered dentist. This point has been discussed during the course of deliberation on the Bill in the Seanad and in this House. There are many other people engaged in the healing process who are not so qualified and who, of necessity, will be involved in clinical trials and they should be covered by this Bill. It is possible one cannot define in legislation a section broad enough to encompass people who may be genuine, or not genuine, so-called faith healers. As no doubt the Minister is well aware, there is a grey area in many of the things that happen to people's illnesses. I make these remarks having regard to the fact that people who are in pain and suffering and who are ill are particularly vulnerable, gullible and open to exploitation. Much good can be done by genuine clinical trials and much harm can be done by bogus attempts to play on people's suffering. The idea of new drugs, new therapies and new cures can ultimately increase human suffering.
The third point I am unhappy about in relation to this Bill is the power of the Minister of the day whoever he may be. Most people will regard the Minister in these matters largely as an instrument of bureaucracy. As we all know, bureaucrats are good and have some knowledge of most matters they deal with. However, it seems in these matters that judgment by one's peers may be far more effective than judgment by bureaucrats. Would it not be better that a person conducting a trial would get the sanction of his peers as well as the sanction of a Minister working through his bureaucrats? A Minister — in this case it may be different — simply will not have the time nor the knowledge and neither will many of his Department officials have sufficient time and knowledge to deal with this problem. Therefore, it is advisable that the conduct of these trials be linked to a far greater extent to professional bodies than is proposed. Abuse of the consents necessary should be deemed malpractice and should involve removal from the register of doctors or dentists, as appropriate. The governing bodies of these professions should set out guidelines for judging a trial to see whether a particular experiment comes within these guidelines and they should sanction it before and after the event.
I wish to refer briefly to the ethics committee. At the end of section 8 is a small subsection which states that the composition of the ethics committee may at any time be changed with the approval of the Minister. This is a rather limited subsection. It does not say how this ethics committee is to be formed or by whom. It is perilously vague. This matter may be covered by section 17 which deals with regulations generally. However, I feel it needs much greater clarification. There should be a much better provision in the Bill for the composition, knowledge and power of the ethics committee. It is important that they be included in the Act and that they be known to exist and be readily ascertainable. For example, should there be an ethics committee of two people or ten people? How should it be composed? Should it be composed of dentists, doctors or legal people and in what combination? A number of disciplines should obviously be brought into force particularly when dealing with the question of consent and the adequacy thereof. Will there be local or regional committees?
Section 8 sets out in some detail the guidelines the committee must consider but it does not set out who the committee should consist of, how they should be composed and what responsibility they ultimately have if they make a mistake. For example, how should they monitor a trial or would they have powers of inspection and entry? I would like the Minister to expand on those points.
As I said already, people who are ill are particularly vulnerable and gullible. At present many of the AIDs victims in the United States are going to Mexico, to Tijuana and such places for local cures which probably in the end will do them more damage than good but it proves that people who are ill will grasp at any straw in order to find a cure. Any person in constant pain is an easy target to consent to anything he thinks might relieve his illness. Much illness is of a mental nature. The cause of the illness may be mental or the effects of the illness may affect the person's mental process. Therefore, the getting of consent is a matter of particular difficulty for people suffering from a mental illness or who are mentally affected by their illness. Yet, however, it is in this field that much progress and much change is necessary. This creates special difficulty and needs a special solution.
The terms of the Bill should be set out in much more detail and should provide for objective impartial checks on the matter of consent. The whole question of consent is a kernel issue in this Bill and is very much open to various interpretations especially by the legal profession. Should the consent not be administered by a person who has no connection with the trial and who has the qualifications to understrand the risks involved and to explain them to the participant in the clinical trial?
I wish to refer to payments for consent. I would like to mention something that has been referred to very often in the newspapers recently about the practice of drug firms paying doctors and hospitals. This seems to be convered by the ethics committee under section 8. It is well known that drug companies dine and wine certain doctors. Is this a payment or an inducement? As reported at column 58 of the Official Report of the Seanad of Wednesday, 1 October 1986, that esteemed doctor, Senator John Robb, referred to a similar experience he had with a drug firm who offered him certain inducements in order to promote a certain drug. What restraints are included in the Bill in regard to this practice? The same happens throughout the whole legal system. We must remember that the integrity of a body is very much recognised as a freedom in this country. This was concluded in the Ryan case of 1965. I would like to ask the Minister how is an ethics committee to value the payment against the risk involved? What is the validity of a contract with a person suffering a mental illness if it can be shown afterwards that the person entering the contract was so mentally deranged that he was not responsible at the time for submitting himself to a trial?
I should like to refer the Minister to an article published in the Irish Law Times in September 1984 which dealt in detail with that aspect. I am glad to have had an opportunity to contribute to the debate. In my sporting career I was exposed to the taking of several different substances before major matches. There are great implications in the Bill for the sporting world. I should like to draw the Minister's attention to a recent case in America when a former Olympic gold medalist was prosecuted for promoting steroids to improve performance. We must also consider the administering of many substances in the sporting world which is out of control at present. How will the Bill affect the administering of substances or gimmicks in the sporting world? That is of great relevance to those involved, particularly our star athletes. Indeed, the more professional the athlete and the more intense competition becomes the more the people involved are influenced to use certain fashionable aids. In a lot of cases those substances have never been acknowledged as being safe.
I welcome the Bill. It is our duty to sponsor beneficial change in our society. Nevertheless, it is equally our duty to ensure the safety of our people against exploitation. The Bill tries to achieve a balance between those ideals. Many aspects of the Bill need to be clarified and, if given the opportunity, I hope to comment on the more technical features of it later.
It is not my intention to delay the House. Deputy Keating earlier, on behalf of the Progressive Democrats, indicated our general acceptance and welcome for the Bill and our agreement for the need for statutory controls in this area of clinical trials where humans are participating. I wish to raise a point in relation to the ethics committee. It seems from the way the Bill is framed that a separate ethics committee will have to be formed for each clinical trial. Will the Minister indicate the names of the members of that ethics committee? Is he aware of the concern expressed about section 8, and the other sections that refer to the ethics committee, by some members of the Irish Medical Organisation? They are concerned about the future role of the National Drugs Advisory Board following the passing of the Bill. Has the Minister received a request that the advisory board be preserved in its present status and role in the arrangement and approval of clinical trials? Has he received a request that they be given a prime executive position by him in the approving of any clinical trials in the future? Has the Minister received a request from them that ethics committees in general hospitals should have as part of their function the granting of local approval for any trials conducted in the committee's own hospital?
The suggestion has been made by the IMO — I am mentioning it in the House to give the Minister an opportunity of putting his response on the record of the House before we move to Committee Stage at a later date — that the proposal in section 8 for the establishment of a separate ethics committee for each clinical trial would be cumbersome and, in their view, eventually unworkable. If that is the considered view of some eminent people in the IMO it raises serious doubts as to the effectiveness of section 8 and of the Bill in general. I hope the Minister refers to that matter when replying so as to clear up the issue.
I should like to thank Deputies for the careful consideration they have given to the provisions of the Bill and the constructive way they have approached it. I have taken careful note of what has been said by each Deputy tonight and on the last occasion the Bill was debated in the House. Several Deputies suggested that members of certain other professions, besides doctors and dentists, should be allowed conduct clinical trials. For example, physiotherapists were referred to specifically in this context. I should like to point out that the Declaration of Helsinki, compliance with which is a prerequisite for approval of clinical trials by most drug regulatory agencies, stipulates that biomedical research involving human subjects should always be conducted under the supervision of a clinically competent medical person and that responsibility for the human subject must always rest with a medically qualified person. In the Irish context, doctors and dentists have always been treated on a par and this is why we have provided that dentists may conduct clinical trials. I might add that an identical situation applies in the United Kingdom.
Specifically in relation to physiotherapists, I am aware that there was some concern about the Bill's implications for ordinary physiotherapy practice and physiotherapy classroom demonstrations. My predecessor, Deputy Desmond, gave an assurance in the Seanad that he was advised by his legal advisers that the Bill would not interfere with the ordinary activities of physiotherapists. I have been similarly advised and I trust that such concern has now been fully allayed.
Deputy Michael Keating referred to the need to cost all proposals coming before the Dáil by way of Bills. I would like to say, at this stage, that it is not envisaged that the proposals in the Bill will give rise to much, if any, additional expenditure. I would remind the House that the National Drugs Advisory Board are already operating a notification scheme for clinical trials currently taking place. Also, in accordance with general policy in these matters, the fees provided for in the Bill will be pitched at such a level as to ensure that this new statutory scheme is self-financing.
Deputy De Rossa and Deputy Deenihan expressed misgivings about the provision in relation to consent. One of the basic principles of the Declaration of Helsinki to which I already referred reads:
In any research on human beings each potential subject must be adequately informed of the aims, methods, anticipated benefits and potential hazards of the study and the discomfort it may entail. He or she should be informed that he or she is at liberty to abstain from participation in the study, and that he or she is free to withdraw his or her consent to participate at any time.
I believe that this is suitably reflected in the Bill's provisions, which stipulate that the proposed participant must be given sufficient — information in a comprehensible form to enable him or her to make a proper judgment on whether to participate in the trial. This consent must be in writing. If, for example, a participant is unable physically to write and give consent in the presence of two witnesses — Deputy Deenihan referred to clinical trials on children and the mentally ill — trials would never be carried out on children if they can be carried out on adult volunteers: it is only in cases of children suffering from serious illness for which treatment was not available would it be anticipated that such trials would be carried out.
In regard to the mentally ill, the consent must be satisfactory to the Ethics Committee — they must be satisfied that the person acting on behalf of the mentally ill person, when the mentally ill person is unable to understand the nature of the trial, is a person whom the Ethics Committee would consider to be competent to give such permission.
There must be a delay of six days after consent has been given by the ordinary volunteer before the clinical trial commences. This would give the participant time to reflect on his decision to participate. The Bill provides that a person may withdraw consent at any time without any contractual liability being incurred. There are additional safeguards when a clinical trial involves patients whose condition the preparation under trial is designed to treat.
Several Deputies referred to the more contentious issue of payments to participants. I believe that some recompense should be allowed for discomfort, for example, the taking of blood samples, and restriction of freedom, because participants may be confined for several days and require to fast and abstain. There should also be payment for travel and meals. However, the Bill clearly empowers the Minister to control the level of such payments. These payments may be offered now only when provided for in a permission granted by the Minister under section 9 (8).
Several Deputies referred to the composition of the Ethics Committee. Guidelines will be drawn up so that applicants will know what the Minister might be expected to approve of in terms of an ethics committee. The applicant will submit the names of the proposed Ethics Committee at the time the application is made. I would regard the following as the minimum requirements: there should be two medical practitioners, neither of whom is involved in the trial to be conducted; a nurse who is actively involved in patient care; one professional non-medical person involved in administration or business; one person with legal training and one member of the lay public who is competent and has integrity and whom the public would be expected to respect. Deputy Briscoe tonight gave us an outline of how an ethics committee of which he is a member operate. Deputy Briscoe who is an esteemed Member of the House is quite satisfied with that ethics committee, that they are competent and that they have the integrity that we would all want to see provided for in this legislation.
Deputies Flaherty and Molloy referred to hospital ethics committees and the need, perhaps, to form a new ethics committee each time it was proposed to carry out trials. I assure the Deputies that the ethics committee in respect of research programmes being conducted in a hospital might well be the general purposes committee of that hospital. Furthermore, a hospital that regularly carries out trials may refer to its ethics committee with a particular application without having to name the members each time so that it would not be necessary to set up a new ethics committee each time a consultant in a hospital wished to conduct a trial.
Deputy Swift had some reservations about the lack of a specific provision in the Bill obliging an applicant to forward insurance details to the Department of Health or the National Drugs Advisory Board. I would point out that the requirement for an applicant to forward a copy of a certificate of insurance to the Minister was dropped by way of amendment during the Bill's passage through the Seanad. It was done because it was considered inadvisable for the Minister to have implied responsibility for confirming in advance that the insurance policy was inadequate. I agree with my predecessor and the Seanad that such a provision would not be appropriate for inclusion in the Bill. However, I would point out that there is an obligation on the Ethics Committee to have regard to the insurance. Deputy Flaherty referred to the insurance provision and the cost that would result for the independent researcher, such as doctors in university or hospitals.
There are some let-outs in the Bill in relation to the trials of products in the course of ordinary medical practice. On the general question of insurance, however, it is necessary to provide for compensation for participants when the risks to participants are basically similar. It would not be equitable to distinguish between patients and healthy volunteers and in relation to insurance arrangements for major pharmaceutical companies and for individual researchers. It is not possible or desirable to develop broadly-based legislation or problems that might arise for individual researchers in specific cases.
The individual doctor engaging in the ordinary course of medical practice is completely exempt from the requirements of the Bill. My legal advice is that ordinary medical practice would cover cancer or hospice care as any preparation being used would be to the possible benefit of the patient. The dividing line between ordinary medical practice and controlled clinical trials become much greyer in relation to other conditions. I cannot provide for every contingency in a broadly based Bill of this kind: it must be left to the integrity of the individual physician to distinguish between ordinary medical practice and medical trials. The law must be complied with.
Deputy Bruton expressed some reservations on the sort of situation comprehended by the provisions of section 9 (7) (a). Except in exceptional circumstances, the consent of each participant must be in writing. Section 9 (7) (a) seeks to cover one of these exceptions, where the patient or participant would be capable of comprehending the significance of his consent but is physically unable to give his written consent — he may have no arms or he may be paralysed. In such a situation he can give his consent in any other manner provided it is given in the presence of two witnesses to the doctor treating him for the illness.
Many of the points made by Deputies were of a very specific nature and arguably would require a lengthy set of specific requirements to be incorporated in the Bill. This would pose a problem on two grounds — it would lead to a very rigid régime of control which might unjustifiably slow up necessary and legitimate research projects, and a closed list of specific requirements might not include a particular provision the relevance of which might only become apparent in the future.
The Bill, as drafted, gives the Minister and the National Drugs Advisory Board a flexibility to specify requirements on the lines of those suggested by Deputies during this debate. While formal approval will be a matter for the Minister, he will rely on the expert advice of the board in arriving at his decisions. All applications will be referred to the board for assessment and for recommendations as to any conditions which should be attached to the Minister's permission. The Minister will also be guided by the board in relation to applications for amendment of permissions to undertake clinical trials and revocations of permissions.
In relation to the ethics committee when Committee Stage of the Bill was taken in the Seanad, an amendment was introduced to section 2 of the Bill as published which was designed to confirm that it would be possible for a hospital which carried out trials regularly to refer to its ethics committee a particular application without having to name the members each time. That deals with the point raised by Deputy Molloy. There will have to be an assurance that the ethics committee will be constituted on the impartial basis required of such committees in accordance with guidelines which will be formulated in consultation with the National Drugs Advisory Board. I hope that this will allay the concern of the Galway branch of the Irish Medical Association.
The question was also raised tonight why the Minister should have authority in the Bill. As in similar legislation, the Minister is responsible to the Dáil and the Dáil is responsible for the legislation. The Minister will consult with and delegate authority to the National Drugs Advisory Board but nevertheless it is important that the Minister have an involvement in the administration of this legislation since the Members of the Oireachtas have the responsible legislative authority.
That deals with the points raised during the debate. Again, I want to thank all the Deputies who contributed. I have no doubt that the constructive and positive attitude displayed during Second Stage will also be in evidence when we take Committee Stage. I will help the Opposition Deputies as much as I can to tease out this very important legislation to ensure that we present an Act that will stand the test of time.
It is difficult to understand from the Minister's reply if he has any intention of proposing amendments on Committee Stage or if he is satisfied with the Bill as it stands, because this might have a bearing on our attitude. Will he sympathetically look at amendments on Committee Stage because we are very seriously concerned about this Bill as drafted?
I do not see this as contentious legislation. I see it as very technical legislation. I have an open mind in regard to amendments. As the Deputy said, this legislation was originally introduced by my predecessor and I am looking at certain sections to see if I might submit amendments.
Question put and agreed to.
When is it proposed to take Committee Stage?
Next Tuesday, subject to agreement between the Whips.
We have already seen the Whips' decision for next Tuesday and it does not include this Bill. This decision was arrived at between the Government Whip and the Fine Gael Whip; the Progressive Democrats and the Labour Party were excluded. It does not make much parliamentary sense to order this business for next Tuesday when we have already seen next week's business circulated.
The Deputy has been here long enough to know that announcements like this are never absolute. Usually the earliest possible date is given on which the Bill might be taken and following appropriate consultations the date is fixed.
It is ridiculous to order that this Bill be taken next Tuesday.
We order the business for the earliest possible date and in this case it is next Tuesday.
We have already seen the document which lists the business for next Tuesday and it does not include this Bill.
We can order it for next Tuesday but it will be taken at the earliest possible date after that.
Committee Stage ordered for Tuesday, 23 June 1987.