May I seek clarification on a few points?
Control of Clinical Trials Bill, 1986 [ Seanad ]: Committee Stage.
SECTION 1.
Question proposed: "That section I stand part of the Bill."
Absolutely.
This is the first occasion on which I have had to pay such close attention to a Bill and I may not be clear on the procedures. Therefore, I ask for your and the Minister's tolerance. The Bill as drafted contains a very wide definition of what is a clinical trial and I welcome that. Can the Minister tell the House whether this definition which is extremely broad will cover health and homeopathic products? I would like to ask another question which relates to the impact this Bill will have on the National Drugs Advisory Board and on the Minister's Department. In that context, the explanatory memorandum to the Bill states that this scheme would replace the existing voluntary arrangements for the clearance of proposals for such trials through the National Drugs Advisory Board and that it would now become a statutory system of controlling clinicial trials. Would the Minister clarfiy what the role of the National Drugs Advisory Board will be and to what extent their work in this area will be superseded by the work done by his Department or does he see the role of the National Drugs Advisory Board expanding?
The terms of this Bill when enacted will apply to everybody who carries out a clinical trial or administers pharmaceutical preparations, such as homeopathics. The role of the National Drugs Advisory Board will mainly be an advisory one.
To date, the National Drugs Advisory Board have dealt with the bulk of the work in relation to the assessment and monitoring of trials. Will there be an increase in the number of staff employed in the section which deals with this area in the Minister's Department? The Minister says that the role of the National Drugs Advisory Board will be an advisory one but is this not in conflict with his intention of reducing duplication? I accept that the Minister inherited this Bill but I have felt since the drafting of this Bill that the role of the National Drugs Advisory Board was inadequately thought out and I feel that they should be more involved in the day to day running of the scheme. Many of my amendments will be to that effect.
As Deputy Flaherty is aware, when this Bill was originally introduced to the Seanad the National Drugs Advisory Board were not given such a role and amendments were accepted to involve them. I agree with the Deputy when she says that there is a need to avoid duplication and at present discussions are taking place between my Department and the National Drugs Advisory Board to ensure that as far as practicable there will be no duplication.
That is going to mean either one of two things. First, the National Drugs Advisory Board will under this improved legislation continue the work they have been doing or, secondly, they will cease to do that work and it will be carried out by the Department. I presume that the latter is unlikely to occur but could the Minister indicate what his thinking is on that matter? Is the Minister saying that the details have not yet been worked out?
The National Drugs Advisory Board will continue to issue product authorisations. Under the provisions of this Bill the National Drugs Advisory Board will assess all the applications and make recommendations to the Minister for Health who will then decide whether or not to approve of a particular trial.
Question put and agreed to.
SECTION 2.
I move amendment No. 1:
I page 4, subsection (2), lines 28 to 30, to delete paragraph (b), and substitute the following:
"(b) the conditions under which the product authorisation was granted are held by the National Drugs Advisory Board to comply with the limits of the condition under which the produce may be used."
The Minister will be very familiar with the arguments in regard to this amendment as they were teased out on Committee Stage in the Seanad. On that occasion an amendment which attempted to do something similar to what I am seeking to do here was not accepted despite the fact that many Senators felt there was a problem in this area. I would like to refer to the problem which this amendment seeks to deal with. The Bill as originally drafted contained no section dealing with existing drugs. Subsequently, this section was inserted into the Bill. It was felt that all of the existing drugs would have to be retested and this section was inserted to deal with that problem. But a problem remained and this amendment seeks to deal with it. It relates to the variations in the way in which drugs are administered. Authorisations are rarely updated and in practice a doctor may decide to prescribe a slightly lower dosage or prescribe two tablets instead of one. That may not be the best example but in the case of an elderly person a doctor may decide to prescribe a lower dose than what is normally prescribed for an average adult. This is being done regularly. Without some form of amendment what would happen is that, unless, say, doctors, chemists or whoever prescribing medicines confine themselves to the strict limits of an authorisation, which may be outdated, they would then have to undergo the full rigours of applying for a new clinical trial in order to change it.
The former Minister, in replying to the Seanad debate, indicated that it was open to the person conducting the trial to go back and seek a change in the authorisation. Is that redress open to the person conducting the trial, to every general practitioner, every consultant in a hospital or anybody who may wish to use the medication? If it is not written into this Bill then it is possible that these people might see themselves in law being obliged to go through the full rigours of a clinical trial. Why can the provision not be written into the Bill in some form, for example, by way of what is advocated in my amendment? It does not afford great freedom. It involves the National Drugs Advisory Board in deciding perhaps on some alternative dosage which might be slightly out of line with the original authorisation but which would be seen to be well within the limits allowable for the drug in question. Has the Minister given this much further thought? Would he consider accepting this amendment?
I have given a lot of thought to this amendment and indeed this section. I would be concerned to ensure that we would not impede legitimate trials in any way. At the same time there is an obligation on us to ensure that we protect the interests of participants. This is a highly technical area worthy of further consideration. I acknowledge that there must be provision in the Bill for clinical trials conducted on existing products or drugs which have been authorised and which may have been on the market for many years. What I am concerned about is that the wording in Deputy Flaherty's amendment would leave the situation uncontrolled when many trials are conducted using such products, for example, if somebody were to use a much higher dosage than that authorised by the National Drugs Advisory Board or in terms of bio-availability, use a higher amount of the pharmaceutical preparation in whatever drug is being used.
I share the Deputy's concern that we would not impede legitimate trials. Nevertheless it is important that we protect the interests of participants in a trial.
I welcome the Minister's willingness to examine this section and to consider the issues involved. I gather the Minister is willing to consider what he believes to be an improved draft which would achieve the same objective. The point the Minister made — that somebody might seriously abuse the limits of an authorisation — is not possible under the provisions of my amendment. The only way in which that authorisation could be varied is on request to the National Drugs Advisory Board and, under the terms of my amendment, any variation can take place only if they allow it.
Therefore, it will be seen that the provisions of my amendment are not very loose. They are quite specific and involve the National Drugs Advisory Board in any deviation from an authorisation. I would ask the Minister to examine this matter closely. My fear would be that many groups here, representing the universities, some of the clinics involved in a good deal of research and so on might be involved in a huge bureaucratic process of setting up a whole new trial. Indeed, the ultimate result would be for the National Drugs Advisory Board simply to say that it could be tried. In fact, under the terms of current procedures this can take place outside the law. I contend that of the writing in of the permission of the National Drugs Advisoty Board affords sufficient protection.
I share the Deputy's concern that we would not impede legitimate trials. A further consideration in relation to Deputy Flaherty's proposal is that it would give the National Drugs Advisory Board a statutory role and considerable discretion in taking decisions in relation to trials using existing products. As in the case of drugs and medicines controlled under other legislation, it is the Minister for Health who is the competent authority in deciding issues of importance like this. It is appropriate that his role should be reflected in any amendment along these lines. I acknowledge that the National Drugs Advisory Board have made a major contribution in controlling clinical trials under the existing voluntary arrangements but, within a statutory framework, it is the Minister who will have primary responsibility. I propose to provide this and a consultative role for the National Drugs Advisory Board. I am prepared to take a look at this section and to bring forward an amendment on Report Stage which I hope will satisfy Deputy Flaherty's and my concern about this section.
I am not particularly favourably disposed to this amendment. I tend to take the view that the overriding concern has to be the protection of participants in trials and that, therefore, any loosening of that control is undesirable. I shall wait and see what the Minister proposes to do but I would not be keen on a loosening of the provisions of that section.
Is section 2 agreed to, bearing in mind that the Minister has given an indication of what he might do on Report Stage?
By way of clarification, I take it what the Minister proposes to do is to introduce an amendment which would achieve the net effect but which would involve the Minister in a decision on any variation, presumably in consultation with the National Drugs Advisory Board? I would be happy with that amendment.
Amendment, by leave, withdrawn.
Section 2 agreed to.
SECTION 3.
Amendment No. 2 in the name of Deputy Flaherty. Amendment No. 3 is related. I propose, therefore, that they be discussed together.
I move amendment No. 2:
In page 4, subsection (1), lines 40 and 41, to delete paragraph (c).
The whole area of ethics committees is the one about which there is most central concern in the House. The ethics committee is a central feature of the provisions of the Bill. The Bill is dependent on its being effective. To a large extent the protection of volunteers or patients is in the hands of the ethics committee. It is extremely important that the way in which members of that committee are appointed is above question in terms of their commitment to supervise trials, in an independent way and to protect the public and personal interests involved. Therefore it would be totally inappropriate — I know many other people share this view — that a person who is proposing to arrange for a trial should be the person who names the ethics committee for that trial. Hence I suggest the deletion of this subsection. Here I gather I may run into the same problem I did with regard to amendment No. 1 in relation to the role I am giving the National Drugs Advisory Board. In reality the Minister will be relying on them and their expertise by way of their consultative role. I am worried that we may be setting up a layer of bureaucracy that, ultimately, may not involve a great deal more supervision but much more bureacuracy, delay in decisions and the handling of trials and may not achieve a great deal more. It is important for us to produce a tightly-worded Bill which will introduce extra controls and impose them on the body which will be providing most of the expert advice and supervision in this area, in other words, the National Drugs Advisory Board, unless I can draw the Minister more on my first question which was: What expansion of staffing, recruitment of new talent or development of talent does he envisage to handle the increased workload involved for his Department in taking on this fairly specialised area? For the purposes we are concerned about, it is not beyond the comprehension of any person of average intelligence. Therefore, it is fundamentally wrong that the person who is going to conduct a trial should in any way nominate members of the ethics committee.
This was debated in the Seanad where an amendment on the lines proposed by The Workers' Party was considered and rejected. The amendment proposed the formation of a national committee. In its place I suggested that another way of solving this problem was that a person who wishes to conduct a clinical trial should apply to the National Drugs Advisory Board — the Minister could say to the Department — for the nomination of an ethics committee to supervise the trial who would normally be either the existing ethics committee for the larger hospitals or ethics committees appointed by the health boards for smaller hospitals or individuals or private companies.
The desire here is clear and I think it is shared by speakers in the other House. Deputy De Rossa can speak for himself but I think that desire is behind The Workers' Party's amendment in this area, namely, that ethics committees should be seen to be appointed by a body with public accountability such as the health boards. Many hospitals have their own ethics committees, and many hospitals where a good deal of research goes on at the moment would be unhappy to have any committee other than their own ethics committee decide ethics for that hospital or supervise activities which have ethical considerations in that hospital. How are these concerns to be balanced?
Some improvement on the current process is necessary. The only reference in the Bill to the appointment of an ethics committee is in section 3 (1) (c) which provides that the identity is detailed by the conductor of the trial and the Minister must approve of it. That is inadequate. It is a fundamental flaw in the Bill which needs to be amended substantially so that all concerned can see clearly that there is public participation in the selection of ethics committees. Confidence must be engendered that ethics committees are selected in a way that will enable them to perform all the functions that will be given to them under this Bill, to protect the interests of the volunteers and not make the ethics committee a tool of the conductor of the trial. Matters must not be left as unspecified and obscure as they are in the legislation currently.
Are we discussing amendment No. 5 as well?
We are discussing amendments Nos. 2 and 3.
They are related. Deputy Flaherty referred to my amendment to section 8. I agree with Deputy Flaherty with regard to the unsatisfactory way in which it is proposed to sanction ethics committees under the present Bill.
It has been decided that your amendment will be taken separately. If you wish that it be discussed now, that may be done.
The matters are related and in order to save the time of the House I think we should discuss them together.
Co-operation will help. We take it that we are discussing, in tandem with amendments Nos. 2 and 3, amendment No. 5 in the name of Deputies De Rossa, Sherlock and McCartan.
They will be taken separately.
We are taking amendment No. 5——
We are taking amendment No. 5 to section 8. We are discussing the three amendments together but we will decide on them separately.
The question of an ethics committee is central to this Bill and is of concern to everybody who is involved, either the people who might be participants in clinical trials or people engaged in the trials. It is not good enough that the companies, hospitals or universities who will be proposing to engage in such trials would have the right to appoint the ethics committees. I do not see that Deputy Flaherty's amendment No. 3 would overcome the problem. She is suggesting that the ethics committees of existing large hospitals, health boards where smaller hospitals are involved, or private companies would be adequate. Certainly if hospitals are appointing their own ethics committees you would have no greater protection there then you would under the present terms of the Bill.
The only way of ensuring confidence in an ethics committee and ensuring that there is no question about the way they operate is to have a national committee appointed by the Minister. This would lift the whole matter out of the area of localised problems with regard to ethics committees which we have seen arising in hospitals of one kind or another, where there are disputes about ethics committees having the right to take certain actions or whether the views they express or the decisions they make are fully in line with the rights of the patient concerned and not dictated by some other consideration. Therefore, it is essential that a national ethics committee be established who would be above all that and who would, as other bodies have suggested, include not only medical people of standing but also lay people of responsibility and standing. Therefore, I urge the Minister to accept amendment No. 5 as a way of resolving the difficulties which I see arising with the Bill and with Deputy Flaherty's amendment.
On the points raised by Deputy Flaherty, an important amendment was incorporated into the Bill on Committee stage in the Seanad which provided that an application for permission to carry out a clinical trial shall be accompanied by "the identity (which includes the qualification of each member) of the ethics committee". This is in section 31 (1) (c) of the Bill. The proposal by the NDAB that they should nominate the ethics committee might lead to undue delay in processing aplications and would not, in my view, add to the control required at this time. The guidelines which will be drawn up by the Minister in relation to ethics committees will guarantee adequately the impartiality and independence of such committees. Nevertheless, it might be desirable, in the light of experience of operating the system, to give the NDAB a role on the lines proposed by Deputy Flaherty if the Bill as drafted does not include such a provision in the future.
Regarding the amendment proposed by Deputy De Rossa, the nature of an ethics committee is such that they require to have close involvement in the supervision of all aspects of the trial. Clearly it is impracticable for a single national body to assume that sort of function. The NDAB will, of course, be the adviser to the Minister on the general acceptability of each proposal. This will, I believe, meet the intention behind the Deputy's proposal. However, it must be borne in mind that in striving to achieve a framework to protect participants in clinical trials it is appropriate that each individual trial be supervised to the greatest possible extent. This would not be possible if we had a single national ethics committee. For these reasons I feel that the amendment would not be appropriate.
I was aware of the problems with a single national committee because of the scale and number of trials conducted. The localised alternative is probably the health boards on which there are locally elected representatives. If the legislation stands as it is, every person proposing to conduct a trial will have to name an ethics committee. What number of ethics committees are envisaged? Will there simply be a recognition of the status quo in regard to ethics committees which operate for hospitals and institutions such as ICP? Are these the kind of committees which the Minister envisages? It is a weakness in the Bill that the matter of ethics committees is left unspecified and many of the central issues are to be dealt with by regulation. This is unfortunate. The, Bill should be more specific as to the make-up of ethics committees. As it stands, it will be outside the ambit of the legislation. Functions are being allocated to these committees, but we do not know how the committees will be made up. We must have a clear indication that these committees will not be the tools of individuals carrying out particular trials and that they will be seen to be independent,. It is not good enough to depend on the goodwill of a Minister who may at some stage — God forbid — have a vested interest. The legislation must stand by itself and must not be dependent on the goodwill of an officer of the State.
The Minister regards the establishment of a national ethics committee as impracticable on the basis that it could not oversee all the individual trials going on at any time, whether in hospitals, pharmacology companies or universities. Committees by their nature tend to sit around tables, discussing things and making decisions. They do not as a body monitor activities. The argument against a national committee does not stand up if we are talking about the practical operations of the committee. Any ethics committee, whether it be a local ethics committee or a university ethics committee, will operate on the basis of reports it receives from perhaps one or two committee members who carry out on-site inspections. It is quite feasible to have a national ethics committee where a number of people would have the right to visit clinical trials in order to monitor what was going on. They should have the right to do so without giving any prior notice to the people promoting the trials. The Minister is not on sound ground when arguing on the basis of impracticality. I have been involved with quite a number of committees at various times and I am aware that the role of a committee is to discuss and monitor on the basis of reports received from individuals on the spot.
Regarding section 8, which I seek to amend, the role set out for ethics committees is to decide on the correctness of the applications and the procedures to be adopted. As far as I can see, there is nothing in that section which gives the ethics committee the right to monitor the trial as it goes on. The Minister might clarify that.
Many hospitals have an ethics committee, as do many of the institutes carrying out clinical trials. It is laid down in the legislation that the names of the committee will be submitted to the Minister when an application is made to carry out such trials. The Minister will then decide whether he approves of the ethics committee. While the constitution of the ethics committee will vary depending on the nature of the trial, it is proposed to formulate guidelines in connection with the National Drugs Advisory Board. This is for the information of applicants so that they will know what the Minister might be expected to approve of in terms of an ethics committee.
The National Drugs Advisory Board would regard the following composition as a minimum: two medical practitioners, neither of whom is personally involved in the study to be conducted; one practitioner at least should be independent of the institution in which the study is to be conducted and one at least should also be personally familiar with the conduct of clinical trials. There should also be a nurse actively involved in patient care and one professional, non-medical person who is involved in administration or business. There should be one person with legal training and one member of the lay public whose competence and integrity the public might be expected to respect.
It is obvious that the ethics committee would represent the various sectors who should have an interest and it would be for the Minister to decide the competence of the committee. If he was not satisfied in that regard, then he would not approve the committee.
A local ethics committee would provide a better safeguard for the participants than a national committee. It would be very difficult for one committee to cope with the large number of trials going on at different locations throughout the country. In 1986 there were 218 applications to the National Drugs Advisory Board under the non-statutory arrangements. With the provision of the Bill requiring detailed information about the composition of an ethics committee, I feel that independence and impartiality are guaranteed in respect of each individual trial.
To return to the specifics of my amendment, I ask the Minister to give it further consideration. In the context of the operation of clinical trials the ethics committees in hospitals have operated with a 100 per cent protection record so far as one can gauge. I asked the Minister earlier this year if there has been any claims arising out of clinical trials in hospitals and the answer was that there has been none. I gather that the reporting of side effects has been minimal according to the National Drugs Advisory Board.
Members of an ethics committee should understand clinical trials and what is involved. Some of these members would be lay people and others would have a business background understanding inducements and the financial implications of decisions made. We might criticise decisions made by ethics committees in our hospitals but so far as clinical trials are concerned, they have operated fairly successfully. However, there was one case which led to this legislation. It involved an independent commerical organisation engaged in clinical trials which was making a great deal of money out of them.
I did not think it appropriate that such institutions could selectively appoint their own ethics committee and under this Bill they will still do so, although the Minister will have the right to agree or turn down the nominations. I do not consider that is adequate. There should be a second tier of protection, and it should not be left to the institution concerned to name those committees without any other guidance than the broad guidelines which are laid down.
The people who deal most closely with the ethics committees are the National Drugs advisory Board and officials in the Department. I believe the National Drugs Advisory Board are happy with some committees but not with others. In a very short time we could develop, through the National Drugs Advisory Board or through the Department, a panel for ethics committees. It should be set down in law and not left to the individual to name a person for membership on such a committee, simply depending on the Minister's yes or no. This is not adequate protection because it does not deal with the question of ethics committees sufficiently strongly.
I ask the Minister to look again at my amendment which says that a person who proposes to arrange for the conducting of a clinical trial shall apply to the National Drugs Advisory Board for the nomination of an ethics committee to supervise the trial, which shall normally be either the existing ethics committee of the larger hospitals or an ethics committee appointed by the health board where smaller hospitals, individuals, or private companies are involved. I believe the health board would be able to provide the necessary expertise and decisions would be taken at a level where there would be public representatives as well as representatives of the medical profession. It is important that private companies should not be the primary mover in setting up their own ethics committee.
It is clear that the Minister has set his mind against the idea of a national committee. With regard to the guidelines which he says will be prepared in consultation with the National Drugs Advisory Board, is he using the suggestions in the report of the Royal College of Physicians of Ireland, who made recommendations on page 12 of their document with regard to the membership and appointment of ethics committees? Section (d) of that report says that both sexes should be represented on that committee. Would the Minister accept that as one of the guidelines?
The guidelines will indicate the type of committee which might be approved by the Minister. Therefore those who wish to carry out clinical trials will be aware of what would be expected. The National Drugs Advisory Board will be advising the Minister for Health, who will also have his own medical and pharmaceutical staff in the Department. Having received that advice, if the Minister is concerned about the impartiality, independence or competence of any member of an ethics committee, he may refuse to accept the ethics committee. I believe there is a sufficient safeguard there to ensure that the rights of participants will be protected.
On Deputy De Rossa's point, the general guidelines I read out were recommendations by the Royal College of Physicians of Ireland.
Does the Minister accept section (d) of that report which recommends that both sexes be represented on the committee?
I do not think it is necessary to accept that paragraph because it need not necessarily be so. What the Minister will be concerned with is the expertise, competence and independence of the ethics committee. The members of that committee may be all men or all women but the important criterion is their expertise, competence and independence.
I appreciate what the Minister is saying with regard to expertise, competence and independence, but there is a very strong body of opinion that in order to get a balanced view of any particular trial, there should be people from both sexes on the committee. It could happen that trials being carried out could affect one or other of the sexes and have an emotional effect which would not necessarily be clear to an all male or an all female committee. I think the possibility of an all female committee is next to nil, not that I would agree that it would be right to have an all female committee, but there is a necessity to ensure that there is representation of both sexes on the committee.
In referring to the guidelines which would be issued, I think the Minister mentioned a lay person who would be a professional. Is that right? He mentioned a legal person, two medical people and a lay person who would be a professional. Is there any reason why that person needs to be a professional?
It may be a member of the lay public whose competence and integrity the public might be expected to respect. It does not have to be a professional person.
One of the sections refers to "the professional".
No, I mentioned two medical practitioners neither of whom is personally involved in the study. One of them at least should be independent of the institution in which the study is to be conducted and one should also be personally familiar with the conduct of clinical trials. I also mentioned a nurse actively involved in patient care, one professional non-medical person who is involved in administration of business, one person with legal training and a member of the lay public.
I accept Deputy De Rossa's point that in certain clinical trials there may be a reason why a person of one or other sex should be represented. That is something the Minister would take into account and if he believes, for example that there should be a woman on the ethics committee he can refuse to approve of the ethics committee submitted to him and make the point that he will not approve of it until the name of a woman who has the expertise, competence and independence is appointed. The Minister may also consider it necessary to have a man on an ethics committee. It is appropriate that the Minister should take account of such matters having regard to a specific trial.
It is obvious that the Minister is working from the guidelines relating to ethics committees produced by the National Drugs Advisory Board. I should like to know why the Minister, and his predecessor, decided against including such a provision in the Bill. There is unease in our party about depending on the Minister rejecting an ethics committee if they are unsuitable. Would it not be better to have the independence of such a committee established at the outset by insuring that they are appointed by outside interested parties? There has been public concern about the adequacy of the supervision of trials. In the course of the Seanad debate the Minister indicated that he might deal with this by way of an informal regulation and not by way of a statutory one. Will the Minister give the House his views on this matter? It is important that he should do so because it will have a bearing on our views on the amendment. The Bill will be flawed if this matter is not resolved.
I am satisfied that the guidelines are the minimum for an ethics committee. The difficulty about writing them into legislation is that an ethics committee may have a different composition depending on the nature of the trial. Deputy De Rossa has raised a point that would have to be taken into account in that regard. The Minister, with the advice available to him and his Department, and the expert advice from the National Drugs Advisory Board, will be in a position to critically assess the expertise, competence and independence of the ethics committee. I am satisfied that there will be sufficient safeguards to ensure that the interests of the participants are protected.
Will the Minister tell the House what function the ethics committee will have to monitor a trial? The Minister has made the point that ethics committees specifically related to each trial would be a better protection for the participant in the trial but will he tell us the role such a committee will have in monitoring a trial and protecting the participant? Will they have a right of access to the centres where the trials are taking place? Will they have a right to request reports or make any investigations they feel necessary in order to allay fears or suspicions they may have in regard to any trial?
The substance of what Deputy De Rossa has said is contained in amendment No. 7 in my name. It is very difficult to deal with these sections separately because they are inter-related. The name we give to a committee is related to the powers we give to such a committee.
If the House agrees we can take amendment No. 7 now and deal with it later.
The amendment in my name states that the ethics committee for a proposed clinical trial shall be entitled to inspect the place where the trial is to be conducted at any time during the preparation for and conduct of the trial. I agree that it should be taken with the other amendments. There is a gap after permission is given to undertake a trial. I understand that in a later section the Minister or a person nominated by him which could be the ethics committee has power to inspect but in my view we should specify that the ethics committee and the National Drugs Advisory Board should have the power to inspect. That would greatly strengthen the supervision of trials.
I take it that we are discussing amendment No. 7 in the name of Deputy Flaherty in conjunction of amendments Nos. 2, 3 and 5.
Amendment No. 5 in my name proposes that the Minister should appoint an ethics committee which shall be responsible for the supervision of all clinical trials conducted in the State. That amendment seeks to establish a national committee for the purpose and to have a committee which will supervise all trials and section 8 of the Bill states:
Where the Minister is satisfied that a proposed ethics committee for a clinical trial is competent to consider the justification for conducting the proposed clinical trial and the circumstances under which it is to be conducted, he shall give his approval of the proposed committee...
The section goes on to outline the criteria which the committee should consider before giving approval. However, there is no provision in the Bill for the ethics committee to monitor what is taking place or provide protection for the participants which the Minister said will be given to local committees.
The sections dealing with the ethics committee are of paramount importance. Section 8 (4) lays down the matters which the ethics committee should have regard to the coming to a decision as to whether there is justification for the proposed trial and the circumstances under which it is to be conducted. Obviously the ethics committee, as already stated, will have to be approved by the Minister. The section says that the committee must satisfy themselves as to the qualifications and competence of the doctors and dentists conducting the proposed trial and also to the resources available to such people. Such resources would include supporting staff, accommodation and equipment. The committee, as well as the Minister, must satisfy themselves as to the criteria used for the recruitment and selection of participants. The committee will have a responsibility to ensure that the recruitment of persons as participants is done in a proper, ethical manner. They will also have a pivotal role in ensuring that the provisions of the Bill in relation to obtaining the consent of participants in trials are fully observed. It is also required that the ethics committee must have regard to the policy of insurance proposed for the cover of participants. The ethics committee must satisfy themselves as to the nature and extent of the medical examination of proposed participants in each case. Generally, this would include consultation with the family doctor but this would not always be appropriate. For example, an applicant may not have a family doctor in which case the committee must ensure that an independent medical examination is arranged for the participant who may be a patient in a hospital and that his medical condition is fully monitored there.
Specific reference to independent medical examination covers situations where the medical examiner might be deemed by the committee to have a direct involvement in the trial or perhaps to be a member of the staff of the company carrying out the trial. The ethics committee must also satisfy themselves as to the arrangements for monitoring the health of participants during the actual trial and afterwards. They, as well as the Minister, must also have regard to details of any proposed inducements or awards, whether monetary or otherwise, to be made for becoming or being a participant. These details must also accompany the application to the Minister for permission to carry out such a trial.
Paragraph (j) requires the ethics committee to have regard to any payment, monetary or otherwise, to be paid to doctors or dentists conducting the trial or any part of the trial. The committee will have to consider, from an ethical viewpoint, whether such payments will be appropriate. They must also satisfy themselves as to the arrangement for ensuring that the identity of each participant in clinical trials remains confidential. Publication of the results of a trial should not breach this confidentiality and the ethics committee must have regard to any payment, whether monetary or otherwise, to be made for facilities used during the clinical trials. This was designed to bring out whether, for instance, in the case of a clinical trial to be conducted in a hospital, it is appropriate that the hospital authorities be compensated for the use of some of their facilities during the trials.
The question of inspection is dealt with in section 11 which permits any person authorised by the Minister, to inspect the place at which the trial is conducted. Such a person could include a member of the ethics committee. It goes without saying that, in practice, every facility sought by the ethics committee in considering a proposal for a clinical trial would have to be given to them in this regard. Section 4 (2) (a) also gives the ethics committee a major say in relation to whether the final ministerial approval may be given to a clinical tiral.
The Minister said, in relation to section 11, that he has the power to seek information and that he may appoint a member of the ethics committee to make inquiries and to carry out inspections. I made the point earlier that the ethics committee should be separated from the centre, company, university or hospital which was carrying out the trial so that there would be absolute confidence in the ethics committee and that there was no question of staff of a company or university, who would be under pressure from such companies and institutions not to rock the boat, becoming involved.
Given the seriousness of the issue with which we are dealing, it is absolutely essential that we have this demonstration of impartiality. In response to my point, the Minister said he felt it was impracticable to have a national committee because they could not monitor all the trials in progress. The Minister now says that they do not have a role in monitoring trials in progress, it is only if he decides to appoint one of them to carry out inspections that they would have a role in that regard. He argued that the ethics committee nominated by the body carrying out the trial would have a better role in protecting the participants. My understanding of what the Minister said is that the ethics committee effectively have no role in protecting the participants other than giving adjudication on whether the proposed trial is properly laid out, that the people carrying it out are professional and so on. However, they have no role in monitoring the clinical trial when it is in progress. That undermines the Minister's argument vis-à-vis the national ethics committee but I know the Minister has set his mind against that approach. I urge him to rethink his position and to take the point I am making, that a national committee would be in a better position with regard to independence to ensure that there would be a supervisory role for a start under my amendment. I urge the Minister to accept my amendment.
It is laid down in section 4 that the local ethics committee must have regard to the extent to which the health of participants is proposed to be monitored during and after clinical trials. This, combined with the role of the National Drugs Advisory Board in advising the Minister and with the Minister's own responsibility to ensure that he is satisfied that the interests of the participant are protected, are sufficient to ensure that that will be the case.
What about section 4 (d)? I wish to stress that the role of the committee is to adjudicate, they must satisfy themselves that the proposed protection of the participant before and after is properly and adequately provided for in the proposal. There is no role for them to carry out a monitoring function once the clearance has been given. That is a function of the Minister and, therefore, the argument against national ethics committees does not stand.
In relation to amendment No. 2 which proposes to delete paragraph (c), those Deputies who have been involved in the consideration of this remain concerned about the independence of ethics committees so appointed. The protection which the Minister is offering to the public, and his reassurance, related to the guidelines the Minister will lay down. As the Minister did not reply to a previous question I asked, I would ask him again if he will tell us what the status of these guidelines will be. Will they be statutory regulations or informal regulations? We wish to be satisfied that they will be statutory regulations laying down the kind of guidelines referred to by the Minister and drawn up by the National Drugs Advisory Board which would take consideration of the issues referred to in section 8, the justification of the proposed trial, the acceptability of the proposed study, the acceptability of the correct actions of those undertaking it and so on. The guidelines should also relate to an issue which is not really dealt with in section 8, the issue of the adequacy of experimental studies and relevant available literature defining potential risks to participants, methods of recruitment, the consent of the participant and compliance with the protocol assurance of accepting financial arrangements to pay appropriate insurance cover and the encouragement and facilitation of good bio-medical research. The statutory regulations should also cover regulations governing the appointment and the make-up of the committee. Will these be statutory regulations or informal guidelines? This is crucial and if we had a categoric assurance that this would be on a statutory basis it might obviate some of the concern in relation to the committee.
While I had not considered making the guidelines statutory by way of statutory regulation I am prepared to consider that although I see a drawback in that it is important in a specific type of trial that we cover all eventualities so that we will not find ourselves in a position where the statutory regulations do not do what we wish them to do. Perhaps we can have a word about it on Report Stage.
In the context of the Minister's commitment I will withdraw the amendment.
Amendment, by leave, withdrawn.
This amendment has been discussed with amendment No. 2.
In the context of the agreement that the guidelines may be statutory, we can return to this issue on Report Stage. This is a fundamental area and I would like to have the Minister's final thoughts on it. If, on Report Stage I am not satisfied that some adequate provision has been made to ensure that independent controls on ethics committees will intrinsically be part of the legislation and the regulations governing it, I will at that stage put down an amendment to achieve that end.
Amendment No. 3 not moved.
Section 3 agreed to.
SECTION 4.
I move amendment No. 4:
In page 5, subsection (1), line 28, to delete "12 weeks" and substitute "6 weeks".
This amendment is intended to ensure as speedy as possible a processing of trials. This is particularly important where trials are being conducted on terminally ill people. In the treatment of cancer new drugs are emerging each day. When a person is terminally ill he, his doctor and his family may be anxious that advantage be taken of new drugs which may help. Speed can be of the essence in these cases. A minimal requirement of 12 weeks could mean that a group of patients suffering from terminal illnesses would not be treated with new drugs. I know that in optimum conditions the Department, the National Drugs Advisory Board and doctors may be able to cooperate, but 12 weeks is too long of an outside limit. Six weeks would be more satisfactory.
Twelve weeks is the maximum time limit permissible. While I hope that in practice it will be possible to process applications in less than 12 weeks, it is important to make sure that there is sufficient leeway to provide for the occasion when a full 12 weeks of consideration might be necessary. The National Drugs Advisory Board might be caused problems if we were to reduce the time to six weeks. We should retain 12 weeks as the maximum time permissible under the Bill.
My understanding is that the National Drugs Advisory Board pride themselves on not having been caught up in the bureaucratic delays that are a feature of departmental handling of matters. The appeal of the body set up as a semi-State body is that there has been flexibility and an ability to deal on a one to one basis with doctors working in hospitals to the benefit of patients. While much treatment will not be affected by the Bill in that it will be direct treatment of individual patients and has been excluded specifically from the Bill, there will be occasions where flexibility and speedy handling of the trials on patients will be important. The speedy processing of various applications has not been a problem for the National Drugs Advisory Board and I understand that they would not find it difficult to cope with a shorter time limit. Whether or not they find it difficult, it is a desirable objective.
I agree with the Deputy on the need to expedite the processing of clinical trials and I recognise the record of the National Drugs Advisory Board. I have no doubt that they would not want to delay unnecessarily the processing of applications but the 12 weeks is about the right balance as the maximum time limit permissible. Six weeks could cause problems for the board and for the person or persons who wish to carry out the trial. If the Minister or the National Drugs Advisory Board did not have sufficient information within the six weeks they would have to refuse permission for the trial and it would necessitate a new application and perhaps a new fee from the person or persons wishing to carry out the trial. While I share the Deputy's concern that the processing of trial applications should be expedited, if we were to reduce it below 12 weeks it might not be in the interests of the persons wishing to carry out the trial. We should leave it at 12 weeks.
I understand from the Minister's reply that he and the Department are committed to minimum rather than maximum limits being observed where possible. At times in the past there were serious problems with delays in other areas of the National Drugs Advisory Board's responsibilities, but in recent times there has been a speedy processing of applications. I would appreciate it if the Minister would undertake to allow flexibility so that there would be an ability to respond speedily as the National Drugs Advisory Board often deal with what are almost emergencies. The Minister should ensure that his Department in undertaking so many extra responsibilities under this Bill, should consider that matter also, while obviously guaranteeing the protection of the patient or individuals involved.
I would be glad to give the Deputy that undertaking. I can assure her now that even at present where there is an emergency and where it is necessary to carry out a trial on a drug, say, as a life saving effort, there is no delay. That is what we wish to see continued.
Amendment, by leave, withdrawn.
Section 4 agreed to.
Section 5 agreed to.
SECTION 6.
Question proposed: "That section 6 stand part of the Bill".
Has the Minister resolved, to anybody's satisfaction, the problem with physiotherapists and their inclusion under the Bill? This is a matter which from the beginning has caused some concern. They are not specifically mentioned because they do not have a register. What are the Department's views on trials that physiotherapists may wish to conduct?
This section confines the conducting of clinical trials to doctors and dentists operating in accordance with subsisting permission granted by the Minister. It does not interfere with the normal pattern of physiotherapy.
Question put and agreed to.
Section 7 agreed to.
SECTION 8.
I move amendment No. 5:
In page 7, line 23 to 29, to delete subsection (1), and substitute the following subsection:
"(1) The Minister shall appoint an ethics committee which shall be responsible for the supervision of all clinical trials conducted in the State.".
This amendment has been discussed already and the Minister has indicated that he is not prepared to accept it. I regard the amendment as a matter of principle in the Bill. It should represent a major element of the Bill and, consequently, I must press it.
Question put: "That the words proposed to be deleted stand".
The Committee divided: Tá, 73; Níl, 13.
Tá
- Abbott, Henry.
- Ahern, Bertie.
- Ahern, Dermot.
- Ahern, Michael.
- Andrews, David.
- Aylward, Liam.
- Barrett, Michael.
- Brady, Gerard.
- Brady, Vincent.
- Brennan, Matthew.
- Brennan, Séamus.
- Briscoe, Ben.
- Browne, John.
- Byrne, Hugh.
- Calleary, Seán.
- Conaghan, Hugh.
- Connolly, Ger.
- Coughlan, Mary T.
- Cowen, Brian.
- Daly, Brendan.
- Davern, Noel.
- Dempsey, Noel.
- Dennehy, John.
- de Valera, Síle.
- Doherty, Seán.
- Ellis, John.
- Fahey, Frank.
- Fahey, Jackie.
- Fitzgerald, Liam.
- Fitzpatrick, Dermott.
- Flood, Chris.
- Foley, Denis.
- Gallagher, Denis.
- Stafford, John.
- Swift, Brian.
- Treacy, Noel.
- Tunney, Jim.
- Gallagher, Pat the Cope.
- Geoghegan-Quinn, Máire.
- Haughey, Charles J.
- Hilliard, Colm Michael.
- Hyland, Liam.
- Jacob, Joe.
- Kirk, Séamus.
- Kitt, Michael P.
- Kitt, Tom.
- Lawlor, Liam.
- Lenihan, Brian.
- Leonard, Jimmy.
- Leyden, Terry.
- Lynch, Michael.
- Lyons, Denis.
- McCarthy, Seán.
- McCreevy, Charlie.
- MacSharry, Ray.
- Mooney Mary,
- Morley, P.J.
- Moynihan, Donal.
- Nolan, M.J.
- O'Dea, William Gerard.
- O'Donoghue, John.
- O'Hanlon, Rory.
- O'Keeffe, Batt.
- O'Keeffe, Ned.
- O'Kennedy, Michael.
- O'Leary, John.
- O'Rourke, Mary.
- Power, Paddy.
- Roche, Dick.
- Smith, Michael.
- Walsh, Seán.
- Woods, Michael.
- Wright, G.V.
Níl
- De Rossa, Proinsias.
- Desmond, Barry.
- Gregory, Tony.
- Higgins, Michael D.
- Howlin, Brendan.
- Kemmy, Jim.
- McCartan, Pat.
- Mac Giolla, Tomás.
- O'Sullivan, Toddy.
- Quinn, Ruairí.
- Sherlock, Joe.
- Stagg, Emmet.
- Taylor, Mervyn.
Tellers: Tá, Deputies V. Brady and Browne; Níl, Deputies De Rossa and Taylor.
Question declared carried.
Amendment declared lost.
We come to amendments Nos. 6 and 15 in the names of Deputies Mac Giolla, De Rossa, Sherlock and McCartan.
I move amendment No. 6:
In page 8, subsection (4), between lines 12 and 13, to insert the following paragraph:
"(i) details of the proposed method or methods by which participants are to be recruited;".
The purpose of this amendment is to try to ensure that the methods to recruit participants in drug trials are not used in a way which would induce people to participate who would not normally want to engage in these trials and to ensure, for instance, that there are no payments to third parties to encourage people to take part. One of the fears of those of us who have been concerned with this area is that the attraction to participate is greatest among those who are least well off. People with no income or very little income may be attracted to participate by offers of money or other inducements when they might not normally consider doing so.
As mentioned earlier, there are a number of criteria set out in this section. It lays down the various matters which the ethics committee will consider before recommending approval of a trial. This is one criterion which should be included with the others. I am not suggesting that the people organising a trial would put financial pressure on prospective participants, but that their own cirumstances may be such that there is financial pressure on them to participate. It may be possible for some of these institutions to engage a third party and pay them to recruit. That should not be allowed. For that reason I am putting forward this amendment which details that the proposed method or methods by which participants are to be recruited should be included as one of the criteria which the ethics committee would consider.
This is a reasonable amendment and one which I hope the Minister might consider accepting. There has been concern, in particular, about persons being recruited from hostels in the city of Dublin for participation in these trials. This amendment would strengthen the Bill and would help to specify this area, although I appreciate that it is touched on directly. We will be supporting the amendment.
I consider that the extent of this proposed amendment is already provided for in the Bill. Under section 8 (4) (c) and (i) the ethics committee have to satisfy themselves as to the criteria to be used for the recruitment and the selection of participants and as to details of any proposed inducements or awards, whether monetary or otherwise, to be made for becoming or for being a participant.
In addition, under section 3 (1) (e) and (f) it is stated that persons who wish to conduct a clinical trial must inform the Minister of the criteria to be used for the recruitment and the selection of participants and the details of any proposed inducements or rewards, whether monetary or otherwise, to be made for becoming or being a participant. It is, therefore, not necessary to amend the Bill in view of the fact that this matter is already covered.
Will the Minister accept that it is quite conceivable that an institution may have difficulty in finding participants for particular trials or indeed that the criteria imposed by the ethics committee or the Minister may restrict the recruitment of participants. This may lead these institutions to circumvent the criteria by using third parties to pay, recruit, or offer inducements to prospective participants. For that reason I urge the Minister to make it necessary that the ethics committee inquire into the methods which an institution would use for recruitment. I know there are sections in the Bill which deal with direct inducements to prospective participants but the amendment is aimed at trying to ensure that other behind-the-door methods would not be used. If the institutions had to specify the methods being used and went outside those, clearly they would be in breach of their conditions.
Speaking as a member of the Ethics Committee of the Institute of Pharmacology, since advertising is now permitted for volunteers there is no question of using third parties — unless the newspapers would be regarded as third parties — to recommend or even to bring along others who volunteer. The small allowance, which is a modest one, which is offered as an inducement to volunteers is well deserved. An inducement was given to those in the FCA to do a couple of weeks duty each year, even if it was only two weeks off work for which they were fully paid.
Let us remember if a public representative sits on an ethics committee and something goes wrong people will immediately descend on him. I am satisfied that this Bill will not only affect the Institute of Pharmacology but all other places where drugs are tested. Since the embargo on advertising for volunteers was lifted recently a large number of people have volunteered, and let me say that each volunteer is fully aware there are risks involved. People sometimes worry about the person who volunteers many times, the professional volunteer, but it is important to remember that the institutes themselves recognise that if anything goes wrong unwanted attention will be focussed on their activities. They are very careful to ensure that there is nothing underhand in their dealings and that everything is open and above board. On many occasions Members of this House have been invited to visit the centre in Dublin and to question the staff. I first became involved in this area when I was invited by the staff of that centre to visit it.
I am sure that everything Deputy Briscoe has said is true and that the institutes have nothing to fear from this requirement being in the Bill. It is only proper that this should be a matter of concern to ethics committees and it is desirable that we have more people volunteering to take part in these trials. The clinics need not fear these restrictions and this amendment in no way threatens the clinical research which is being undertaken and which we wish to see being carried on. One of the problems which I have is that the requirement on the ethics committee is rather loosely drafted in that it states they should have regard to a whole list of things and this could mean any one of one hundred things. I do not know what the legal interpretations of having regard to inducements is and what it would require them to do. It is a very loose definition and that is why a more specific definition should be inserted.
I am satisfied that the points which were raised by both Deputy De Rossa and Deputy Flaherty are covered in the Bill. There is a provision in section 7 of the Bill for the Minister to revoke the permission which was given to undertake a clinical trial if he is not satisfied with the manner in which it is being carried out. As I say, I am satisfied that the points raised are covered in the Bill but I will be pleased to accept the amendment if the Deputies are anxious that it should be accepted. I have no difficulty in accepting this amendment.
I would like to thank the Minister for accepting this amendment.
Amendment agreed to.
Amendment No. 7 has already been discussed and disposed of.
It has not been decided upon. I move amendment No. 7:
In page 8, between lines 25 and 26, to insert the following subsection:
"(5) The ethics committee for a proposed clinical trial shall be entitled to inspect the place where the trial is to be conducted at any time during the preparation for and conduct of the trial.".
This is an important issue. The Minister has indicated that he can instruct a member of an ethics committee to inspect a place where a clinical trial is being conducted but the Bill would be strengthened if it contained a provision to allow for inspecting the place where a trial is to be conducted at any time during the preparation for and conduct of a trial. Although we discussed this amendment already we have not disposed of it and it should be pressed.
We have already discussed this amendment.
Yes.
What is the Deputy suggesting?
I am indicating I am pressing the amendment.
Amendment put.
The Committee divided: Tá, 56; Níl, 76.
Tá
- Barnes, Monica.
- Barrett, Seán.
- Barry, Peter.
- Begley, Michael.
- Birmingham, George.
- Boland, John.
- Boylan, Andrew.
- Bruton, John.
- Bruton, Richard.
- Burke, Liam.
- Carey, Donal.
- Connaughton, Paul.
- Cooney, Patrick Mark.
- Cosgrave, Michael Joe.
- Creed, Donal.
- Crotty, Kieran.
- Deasy, Austin.
- Deenihan, Jimmy.
- De Rossa, Proinsias.
- Desmond, Barry.
- Doyle, Avril.
- Dukes, Alan.
- Durkan, Bernard.
- Nealon, Ted.
- Noonan, Michael. (Limerick East).
- O'Sullivan, Toddy.
- Quinn, Ruairí
- Enright, Thomas.
- Farrelly, John V.
- FitzGerald, Garret.
- Fitzpatrick, Tom.
- Flaherty, Mary.
- Flanagan, Charles.
- Gregory, Tony.
- Griffin, Brendan.
- Harte, Paddy.
- Hegarty, Paddy.
- Higgins, Jim.
- Higgins, Michael D.
- Howlin, Brendan.
- Hussey, Gemma.
- Kemmy, Jim.
- Kenny, Enda.
- McCartan, Pat.
- McGahon, Brendan.
- McGinley, Dinny.
- Mac Giolla, Tomás.
- Mitchell, Gay.
- Mitchell, Jim.
- Naughten, Liam.
- Shatter, Alan.
- Sheehan, P.J.
- Sherlock, Joe.
- Taylor, Mervyn.
- Taylor-Quinn, Madeline.
- Yates, Ivan.
Níl
- Abbott, Henry.
- Ahern, Bertie.
- Ahern, Dermot.
- Ahern, Michael.
- Andrews, David.
- Aylward, Liam.
- Barrett, Michael.
- Brady, Gerard.
- Brady, Vincent.
- Brennan, Matthew.
- Brennan, Séamus.
- Briscoe, Ben.
- Browne, John.
- Byrne, Hugh.
- Calleary, Seán.
- Collins, Gerard.
- Conaghan, Hugh.
- Connolly, Ger.
- Coughlan, Mary T.
- Cowen, Brain.
- Daly, Brendan.
- Davern, Noel.
- Dempsey, Noel.
- Dennehy, John.
- de Valera, Síle.
- Doherty, Seán.
- Ellis, John.
- Fahey, Frank.
- Fahey, Jackie.
- Fitzgerald, Liam.
- Fitzpatrick, Dermott.
- Flood, Chris.
- Foley, Denis.
- Gallagher, Denis.
- Gallagher, Pat the Cope.
- Geoghegan-Quinn, Máire.
- Haughey, Charles J.
- Hilliard, Colm Michael.
- Hyland, Liam.
- Jacob, Joe.
- Kirk, Séamus.
- Kitt, Michael P.
- Kitt, Tom.
- Lawlor, Liam.
- Lenihan, Brian.
- Leonard, Jimmy.
- Leyden, Terry.
- Lynch, Michael.
- Lyons, Denis.
- McCarthy, Seán.
- McCreevy, Charlie.
- MacSharry, Ray.
- Mooney Mary,
- Morley, P.J.
- Moynihan, Donal.
- Nolan, M.J.
- Noonan, Michael J. (Limerick West).
- O'Dea, William Gerard.
- O'Donoghue, John.
- O'Hanlon, Rory.
- O'Keeffe, Batt.
- O'Keeffe, Ned.
- O'Kennedy, Michael.
- O'Leary, John.
- O'Rourke, Mary.
- Power, Paddy.
- Reynolds, Albert.
- Smith, Michael.
- Stafford, John.
- Swift, Brian.
- Treacy, Noel.
- Tunney, Jim.
- Tunney, Jim.
- Walsh, Seán.
- Woods, Michael.
- Wright, G.V.
Tellers: Tá, Deputies Flanagan and Durkan; Níl, Deputies V. Brady and Browne.
Amendment declared lost.
Section 8, as amended, agreed to.
SECTION 9.
I suggest that amendments Nos. 7a, 8 and 8a are related and that they be taken together.
Are we taking all three together?
It is proposed to take Nos. 7a, 8 and 8a together.
I move amendment No. 7a:
In page 8, subsection (3). between lines 39 and 40, to insert the following:
"(c) the participant has been assessed and proposed by a general practitioner, independent of the investigator conducting the trial.".
Do I move No. 8?
You move only one amendment. Let me explain to the House that it is proposed to take amendments Nos. 7a, 8 and 8a together and discuss them.
In moving No. 7a, do I move amendment No. 8 with it?
You move amendment No. 7a but we discuss the lot. We are discussing with No. 7a, Nos. 8 and 8a.
Are they to be decided separately?
Amendment No. 7a to section 9 is necessary in that section 9 has perhaps the tightest regulations in relation to consent and participation in a clinical trial. Section 8, which gives broad guidelines, provides that the ethics committee must have regard to persons selected as participants undergoing independent medical examination before, during or after the clinical trial. This is a broad requirement and is loosely drafted. It does not indicate a specific requirement. The NDAB draft guidelines on informed consent participants specify that a central feature of all proper, informed consent should be an independent medical examination. If the NDAB consider that to be a practical requirement I do not see how it would be severely intrusive on any conductor of a trial or would inhibit in any way the conduct of a proper trial. It would simply be a safeguard that they would welcome and it would benefit people who, against their own interest, might seek to be involved in a trial for financial or other reasons. Therefore, this amendment is desirable to ensure that the volunteers are protected and that the trials are conducted properly. I gather that it would have the approval of the NDAB and the WHO.
Amendment No. 8a proposes that consent as outlined in section 9 (3) will be valid only if given in the presence of a disinterested but informed witness. Again this is a desirable safeguard. It should not prove difficult to implement, and it would ensure that this Bill does two tasks. One is to ensure that desirable medical research will continue and be encouraged and welcomed. Secondly while we are addressing this issue in a total absence of any statutory regulation of the conduct of trials, we should do it properly. Therefore we must ensure that there is an element of independent investigation. Both of these amendments will help to achieve that. I hope the Minister will accept them and that the House will support them.
The amendment in my name and that of Deputy Mac Giolla, Deputy Sherlock and Deputy McCartan seeks to provide that the responsibility for ensuring that the participant comprehends the nature of the consent he is giving lies with the institution who propose to carry out the trials. As far as I can find in my reading of the Bill, there is no indication anywhere of where the responsibility lies for ensuring that the participant comprehends what is going on. One section provides that no trial shall be carreid out unless the person comprehends, but there is no implication in the Bill of where the onus lies for accepting responsibility for assuring that that comprehension is there.
Section 8 of the Bill obliges the ethics committee to satisfy themselves on the circumstances under which the trial is to be conducted. In considering these circumstances it is the responsibility of the committee to have regard to a number of issues including the following: the criteria to be used for the recruitment and selection of participants, the extent and nature of the medical examination that persons selected as participants are to undergo before participating in the clinical trial, and whether the persons selected as participants are to undergo independent medical examination before, during or after a clinical trial.
The onus is on the ethics committee under section 8 (4) (d) to ensure that the procedures proposed by the person conducting a clinical trial for complying with section 9 are sufficient to protect the participants. This would not preclude the assessment of participants by general practitioners if the ethics committee felt that this was desirable and section 8 (4) (h) provides effectively for the issues raised by Deputy Flaherty in her amendment No. 7a.
Amendment No. 8 is presumably designed to ensure that participants are not coerced into participating in a clinical trial. The totality of section 9 is to ensure that potential participants are left in no doubt as to where they stand vis-à-vis the nature of the trial, its details, the possible risks and benefits. There is a cooling off period of six days provided for within which a participant can assess his position and perhaps decide not to participate in the trial. He can also opt out at any stage during the trial without penalty. The framework contained in section 9 provides ample protection for the participant by avoiding coercion or undue pressure and it ensures that the fullest information is made to each participant. I do not see need to introduce a provision which would involve disinterested but informed witnesses, but I acknowledge that in certain cases witnessses would have to be involved. I have already provided for such a requirement in section 9 (6), (a) and (b).
Regarding amendment No. 8a, a key provision in section 9 (3) is that the consent given by the participant to the person conducting the trial, or to a person acting on behalf of the person conducting the trial, can only be given if the participant is capable of comprehending the nature, significance and scope of his or her consent. Implicit in this provision is that the person conducting a trial must be satisfied that the person so consenting is capable of comprehending the nature, significance and scope of his or her consent. For these reasons I feel that the concern expressed by the Deputy is adequately reflected in the Bill as it stands. I do not see the need to have these amendments inserted.
Since the Minister feels it is necessary in section 9 (6) to include provision for a witness, why does he believe that a similar provision is not necessary in the case of trials involving volunteers? What difficulty does he see in accepting the amendment relating to supervision by a medical practitioner, a medical examination and the involvement of a disinterested but informed witness in supervising both the consent and the explanation? It gives a double check so that people know what they are entering into and ensures that the consent is given in a proper environment following a clear explanation. It strengthens the protective part of the Bill. If it is desirable in the case of a person who is ill in hospital, surely it is equally desirable in the case of a volunteer. I know we are breaking new ground by legislating in this area but it is important that we do so properly. These rules and regulations would be in the interest of all and would allay much public concern.
I refer to my amendment, No. 8. Under section 8 (4) (d) the ethics committee must take into account the procedures proposed for compliance with section 9. I do not regard that as an adequate protection. There is no clear definition as to where the responsibility lies, though the Minister says it is implicit in section 9. The section states that a person shall not be a participant in a clinical trial unless a consent to such participation has been given in accordance with this section. It goes on to list the requirements. The consent of the participant must be given in writing and shall not be valid for the purposes of this section unless the person so consenting is capable of comprehending the nature, significance and scope of his consent, which must be obtained by or on behalf of the person conducting the clinical trial. The implication is that if something goes wrong it will then be found that the consent was invalid. That is not sufficient protection. I know it is not possible to cover every loophole but we must try as far as we can to put the onus on the people who are conducting the trial to ensure that the person to whom they have given the written form containing all the details is capable of comprehending what is involved. As the Bill stands, if something goes wrong and a person is damaged or dies, there will be a claim against the institution. We must try to ensure that this kind of situation is avoided. It must be clearly stated that it is the responsibility of the institution involved to ensure that the person consenting to the trial is capable of comprehending the risks involved. It is not enough that this should be implicit.
Section 9 (3) states:
Any consent given for the purposes of this section shall not be valid unless——
(a) the person so consenting is capable of comprehending the nature, significance and scope of his consent, and
(b) it is obtained by or on behalf of the person conducting the clinical trial.
That would appear clearly to deal with the issue raised by Deputy De Rossa. It is very positive and points out very clearly that the consent is not valid unless the person is clearly capable of comprehending the nature, significance and scope of his consent. The person also has a six-day cooling off period during which he may decide not to participate in the clinical trial. Even during the trial he can opt out at any time without penalty.
On the matter raised by Deputy Flaherty, it is only right that a person who is incapable of comprehending the nature, significance and scope of his consent should have an independent person present who is competent to give such a decision on his behalf.
The Minister argues that the obligation on the institution is implicit in section 9 (3) (a) and (b). In order to allay my fears in this regard, would he include an explicit statement to that effect in whatever regulations or guidelines he introduces for the ethics committee so that there will be no question about it?
I will certainly look at the matter raised by Deputy De Rossa and in drawing up the guidelines I will take account of the points raised by him.
I am anxious to press these amendments because these are important practical regulations which would ensure that the volunteer is protected. The Minister did not reply specifically to my question as to why it was necessary to have independent witnesses in the case of a person suffering from an illness but not in the case of a volunteer. These people would be covered by my amendment which is similar to the guidelines already issued by the National Drugs Advisory Board to those who seek advice from them to ensure an informed consent. I believe this reasonable amendment will strengthen this legislation because it will provide protection for the volunteers about whom Deputy De Rossa and I are concerned.
I will deal again with the point raised by Deputy Flaherty. It is only right that a person who is not in a position to understand fully the nature, significance and scope of the consent should have somebody competent to make such a decision on their behalf. I have in mind, for example, a person who might be unconscious from a stroke and his doctor might decide to try a certain form of treatment which would be in the nature of a clinical trial. That person would not be competent to make a decision for himself and, in his interests, it would be only right that somebody who is competent to do so should make that decision on his behalf.
I am satisfied that section 9 (3) (a) and (b) ensures that the interests of the participant are protected and that no such trial can be carried out unless the person so consenting is capable of comprehending the nature, significance and scope of his consent.
This section refers to a person who is capable of comprehending the nature, significance and scope of the consent but it requires two witnesses to the consent to be given to the medical practitioner. I believe it would be desirable to have two forms of independent assessment as to suitability, as can be seen in my amendments. I realise this would be an extra responsibility for patients but, given the traditional type of volunteer who participates in clinical trials, we have a social obligation to ensure that they are given every chance to know exactly what they are doing. We can only benefit from such a move particularly when we are opening up this area, taking it out of the dark world and trying to attract more healthy volunteers. We must provide protection in this legislation for those people and we should do a good job now.
All volunteers are healthy. No unhealthy person will be taken for such tests unless they are healthy and have passed a very rigorous medical examination.
What about arthritic drugs?
Amendment put.
The Committee divided: Tá, 55; Níl, 76.
Tá
- Allen, Bernard.
- Barrett, Seán.
- Barry, Peter.
- Begley, Michael.
- Birmingham, George.
- Boylan, Andrew.
- Bruton, John.
- Bruton, Richard.
- Burke, Liam.
- Carey, Donal.
- Connaughton, Paul.
- Cooney, Patrick Mark.
- Cosgrave, Michael Joe.
- Creed, Donal.
- Crotty, Kieran.
- Deasy, Austin.
- Deenihan, Jimmy.
- De Rossa, Proinsias.
- Desmond, Barry.
- Doyle, Avril.
- Dukes, Alan.
- Durkan, Bernard.
- Enright, Thomas.
- Farrelly, John V.
- FitzGerald, Garret.
- Fitzpatrick, Tom.
- Flaherty, Mary.
- Flanagan, Charles.
- Gregory, Tony.
- Griffin, Brendan.
- Harte, Paddy.
- Hegarty, Paddy.
- Higgins, Jim.
- Higgins, Michael D.
- Howlin, Brendan.
- Hussey, Gemma.
- Kemmy, Jim.
- Kenny, Enda.
- McCartan, Pat.
- McGahon, Brendan.
- McGinley, Dinny.
- Mitchell, Gay.
- Mitchell, Jim.
- Naughten, Liam.
- Nealon, Ted.
- Noonan, Michael. (Limerick East).
- O'Sullivan, Toddy.
- Quinn, Ruairí.
- Shatter, Alan.
- Sheehan, P.J.
- Sherlock, Joe.
- Stagg, Emmet.
- Taylor, Mervyn.
- Taylor-Quinn, Madeline.
- Yates, Ivan.
Níl
- Abbott, Henry.
- Ahern, Bertie.
- Ahern, Dermot.
- Ahern, Michael.
- Brady, Vincent.
- Brennan, Matthew.
- Brennan, Séamus.
- Briscoe, Ben.
- Browne, John.
- Byrne, Hugh.
- Calleary, Seán.
- Collins, Gerard.
- Conaghan, Hugh.
- Connolly, Ger.
- Coughlan, Mary T.
- Cowen, Brian.
- Daly, Brendan.
- Davern, Noel.
- Dempsey, Noel.
- Dennehy, John.
- de Valera, Sín.
- Doherty, Seán.
- Ellis, John.
- Fahey, Frank.
- Fahey, Jackie.
- Fitzgerald, Liam.
- Fitzpatrick, Dermott.
- Flood, Chris.
- Foley, Denis.
- Gallagher, Denis.
- Gallagher, Pat the Cope.
- Geoghegan-Quinn, Máire.
- Haughey, Charles J.
- Hilliard, Colm Michael.
- Hyland, Liam.
- Jacob, Joe.
- Kirk, Séamus.
- Kitt, Michael P.
- Andrews, David.
- Aylward, Liam.
- Barrett, Michael.
- Brady, Gerard.
- Kitt, Tom.
- Lawlor, Liam.
- Lenihan, Brian.
- Leonard, Jimmy.
- Leyden, Terry.
- Lynch, Michael.
- Lyons, Denis.
- McCarthy, Seán.
- McCreevy, Charlie.
- MacSharry, Ray.
- Mooney Mary.
- Morley, P.J.
- Moynihan, Donal.
- Nolan, M.J.
- Noonan, Michael J. (Limerick West).
- O'Dea, William Gerard.
- O'Donoghue, John.
- O'Hanlon, Rory.
- O'Keeffe, Batt.
- O'Keeffe, Ned.
- O'Kennedy, Michael.
- O'Leary, John.
- O'Rourke, Mary.
- Power, Paddy.
- Reynolds, Albert.
- Roche, Dick.
- Smith, Michael.
- Stafford, John.
- Swift, Brian.
- Treacy, Noel.
- Tunney, Jim.
- Walsh, Seán.
- Woods, Michael.
- Wright, G.V.
Tellers: Tá, Deputies Flanagan and Durkan; Níl, Deputies V. Brady and Browne.
Amendment declared lost.
May I ask how amendments Nos. 8 and 8a now stand? Are they being pressed to a vote?
Must we consider them tonight?
No. As we have now encroached ten minutes into Private Members' time I am suggesting that we adjourn the debate.
On the basis of the Minister's undertaking to have a look at my amendment No. 8, I will withdraw it.
Amendment No. 8 not moved. Progress reported; Committee to sit again.
When is it proposed to resume the debate on the Bill?
On Wednesday next, subject to agreement between the Whips.