Control of Clinical Trials Bill, 1986: Report and Final Stages.
An Leas-Chathaoirleach
Before we begin I would like to remind my colleagues that the proposer of the amendment may close the debate on the amendment but no other Senator may speak more than once. I say that to be helpful because there are quite a few amendments on Report Stage. Amendment No. a1. is on the additional amendment list; it is a ministerial amendment. Amendments Nos. a1, 10 and 11 are related and may be discussed together.
Government amendment No. a1:
In page 4, to delete lines 12 to 15 and substitute "purpose of an application under section 3 be treated as if they had not been made otherwise than in accordance with that section."
Briefly, this amendment is consequential on amendments Nos. 10 and 11 being accepted. The purpose of the amendment is to delete the reference in section 2 (1) (b) to section 10, which are no longer appropriate because of amendments Nos. 10 and 11. Senators will recall that I indicated on Committee Stage that I accepted the representations of Senators that it was unnecessary and probably impracticable to require a person to have a policy of insurance before he undertook the preliminary arrangements for the conductng of a trial. It is in that spirit that the amendment is put down on Report Stage. As Senator FitzGerald will recall, he made specific representations in that regard.
Amendment agreed to.
An Leas-Chathaoirleach
Amendments Nos. 1 and 7 are similar and may be discussed together.
Government amendment No. 1:
In page 4, line 45, after "used for" to insert "the requirement and".
Senator Brendan Ryan will recall that he was very much involved in the origins of this amendment. This amendment would put it beyond doubt that the criteria for selection of participants, referred to in section 3 (1) (e), should also include information about the methods by which participants are to be recruited. Therefore, if that important amendment is accepted by the House a corresponding amendment is proposed to section 8 (4) (c), about the responsibilities of ethics committees — that is amendment No. 7. Accordingly, as you have indicated, a Leas-Chathaoirligh, these are being taken together. I think I meet the wishes of the House as expressed on Committee Stage and in particular I meet the representations made on this important point by Senator Brendan Ryan.
Very briefly, I want to thank the Minister. I am impressed with the economy in the use of English achieved by the parliamentary draftsman; it took me about two lines to express that amendment. I have to revise my opinion of the parliamentary draftsman upwards — there was a bad patch for a while. The amendment goes a long way towards making it perfectly clear that ethics committees will have to keep a very watchful eye to ensure that some of the alleged practices we were all very worried about — which I accept did happen — do not become commonplace. Obviously they will now have to direct their attention to the criteria for recruitment. I thank the Minister for being quite forthcoming and being quite prepared to listen to reasonable arguments.
Amendment agreed to.
Government amendment No. 2:
In page 6, to delete lines 6 to 9 and substitute "the person who applied for the permission shall make an application to the Minister for an amendment thereof and the Minister shall, after consultation with the National Drugs Advisory Board and not later than 6 weeks after the application for the amendment was so made, either agree or not agree to the amendment of the permission."
The amendment was requested by a number of Senators and in particular by Senator FitzGerald. The wish of the Senators was that we should provide a time limit for consideration by the Minister of applications for amendments to permissions. I indicated on Committee Stage that I thought there was considerable logic in that position because there is a time limit for considering original permissions. As the Senators will recall the time for consideration of an application for a permission is 12 weeks. Senator FitzGerald tentatively suggested three weeks as a specific time limit. I have put in the amendment — I would ask for the support of the House in this regard and for the consideration of my proposal by the Senator — a time limit of six weeks because I felt that three weeks would be a very short time and for a variety of reasons — the Minister might not be available in a three week period. A somewhat longer period would seem prudent, to enable any amendment to a permission to be considered; it is half the time of application.
I am very happy with both the Minister's earlier amendment and this one. I do not want to cause unnecessary delay in the enactment of the Bill but I would like the Minister to consider one point before we finally put the stamp of approval of Seanad Éireann on the amendment. We are talking about 12 weeks, then a gap, and six weeks. That is what is involved when we are dealing with a trial where perhaps an explanation is required, in order to satisfy the Minister, to be furnished to the National Drugs Advisory Board. In all, it is a long time. I am not pushing this point but I am asking the Minister for his reaction.
If you go for planning approval, even the most minor planning approval the local authority will not answer you until the end of the two-month period. It may be different in parts of rural Ireland, say, in County Clare. The Minister, from his own experience, will know that in the greater Dublin area the approval will only issue at the end of that statutory period. Are we to find a situation here in this context where somebody has been refused permission to take part in a trial and they come in with an additional submission? It has taken 12 weeks already and they consider their position for a fortnight or maybe a week. Then they have to wait for another six weeks to get that through its stages, due perhaps to some misunderstanding between the applicant and the board or Minister. If the Minister wants to insist on six weeks — and I am quite happy with that — could he say something to the effect that they will not be holding back decisions in relation to appeals any more than is necessary even though they have six weeks to decide them?
I can understand his point about the summer holidays and so on. Could they be asked by the Department of Health to deal with these more expeditiously than they will deal with the average situation, given that there has been an 18 week or 20 week period in trying to get approval through all stages.
We received the Government amendments today and the office of the Clerk provided us with the relevant numbers and so forth. It is not possible to get something that refers us back — say, myself, or Senator Brendan Ryan, or anybody else who is involved in amendments — to the origin of the matter? In other words, could we get some sort of explanatory background? It may not be part of the workings of this House but it strikes me as something that might be a very useful guide to people faced with the simple words that a parliamentary draftsman so correctly prepares. It is not very clear unless you are going to spend you time doing algebra and geometry to discover——
An Leas-Chathaoirleach
I am advised that the Committee Stage debate is laid before you. Is that not sufficient?
Do you understand my point? All I am trying to say is that it might be helpful if we could be referred back to the points the Minister made so that the sequence could be established from Committee to Report Stage. I am just making the general point. Perhaps it is a matter for the Committee on Procedure and Privileges.
An Leas-Chathaoirleach
I understand what the Senator is saying, but I do not think while we are on the second amendment to the Control of Clinical Trials Bill is the time to raise it. I shall talk to the Cathaoirleach about it.
An Leas-Chathaoirleach
Could we now agree to amendment No. 2?
I would like to make a brief response. Following Committee Stage we had a discussion at official level between the Department representatives and the director of the National Drugs Advisory Board. On balance, the view was that six weeks was a reasonable compromise. This will not, however, preclude me from issuing guidelines or from within the guidelines urging that both the NDAB and ourselves expedite any amendment applications and not stretch it out until the end of the six weeks. I have that on record now and I have no doubt that our colleagues in the Department will do their utmost to expedite the matter.
Amendment agreed to.
Government amendment No. 3:
In page 6, to delete lines 10 to 18 and substitute the following:
"(2) Where under subsection (1) the Minister agrees to an amendment, it shall not be acted upon—
(a) in the case of a proposed clinical trial, until the ethics committee for the proposed trial has given its approval to the proposed trial (as so amended) in accordance with section 8 (2),
(b) in the case of a clinical trial which has been approved by the ethics committee—
(i) until the committee has given its approval to the amendment,
and
(ii) in respect of each person to whom one or more substances or preparations are to be administered, until the person who has given or gives his consent in accordance with section 9 has been made aware of such matters (if any) as the committee considers he should be made aware of having regard to the amendment."
This amendment will provide that the ethics committee may make its agreement to an amendment of a permission subject to a requirement that certain matters relating to the amendment be brought to the attention of participants. This is because it is possible that the nature of an amendment might be such as would have a bearing upon the participant's willingness to continue to be involved in the trial. Of course, not all amendments would necessarily be of such a nature and might not necessarily involve the consent of the participants. For example, if it were decided to use a greater number of participants than had originally been decided, that might not be germane to the individual participant. I accept the point made on Committee Stage that the ethics committee may make its agreement to an amendment subject to the requirement that certain matters, as I indicated, could and would be brought to the direct attention of the participants involved. It is an important amendment.
I am happy with the amendment. I would have preferred a little more. I always think the best person to look after an individual's interest is the individual properly informed. There is a slight element of somebody else knowing what is good for a third party involved in the amendment. It is a huge improvement on what was there before and I do not wish to give the impression that I am opposing it. I am not: I welcome the amendment, but I have a slight philosophical reservation about experts of any kind being left to decide, as the amendment says "such matters (if any) as the committee considers he should be made aware of..." There is a slight implication of paternalistic benevolence there. It is like saying: "Do not worry your pretty little head: we will make sure everything is OK."
The Minister was most forthcoming here in the House and subsequently about the problems and, therefore, I am happy with the amendment. I am not happy that we should walk ourselves into a situation where other people can decide what is good or bad for an individual. Nevertheless, as in the case of the previous amendment, I welcome it and I am very grateful for it.
Amendment agreed to.
An Leas-Chathaoirleach
Amendments Nos. 4 and 5 are similar and may be discussed together.
Government amendment No. 4:
In page 6, line 37, to delete "a" before "medical".
These are essentially drafting amendments. Their purpose is to put it beyond doubt that references to "medical practice" and "dental practice" cover activities within a hospital as well as general practice outside a hospital. It is fairly important tightening up of the situation.
Amendment agreed to.
Government amendment No. 5:
In page 6, line 38, to delete "a" before "dental".
Amendment agreed to.
Government amendment No. 6:
In page 7, line 6, after "at any time" to insert "and after consultation with the National Drugs Advisory Board".
I have assured Senators that I accept it is reasonable that the Minister of the day should seek the advice of the National Drugs Advisory Board before revoking a permission since, in the first instance, he acts on their advice in the granting of the original permission. That is the purpose of the amendment and it meets the wishes of Senators.
Amendment agreed to.
Government amendment No. 7:
In page 7, line 41, after "used for" to insert "the recruitment and".
Amendment agreed to.
An Leas-Chathaoirleach
Amendments Nos. 8 and 9 are related and may be discussed together.
Government amendment No. 8:
In page 8, to delete lines 33 to 36 and substitute the following:
This amendment is necessary because of the following amendment, No. 9. The amendment provides for a delay before the commencement of a trial following the informing of a proposed participant of the objectives and the risks associated with the trial. Senator Brendan Ryan and his colleagues made the point that the existing provision implies that the participant might be informed of those matters by the person administering the substance or preparation, but that this is unlikely to be the case where there is a delay of up to one week before the substance is administered. The proposed new provision is regarded as a more suitable wording even if it were not required by the new delay provision proposed.
I welcome amendment No. 9 and am very pleased but I have a caveat about all these things. I am not sure the Minister's perception of "appropriate" and the individual's perception of "appropriate" at the receiving end would necessarily coincide. I am very happy that we have taken a large part of the discretion away. Individuals, whether they wish to or not, will have to postpone participation. I believe the fact that there will be a long hiatus ought to be capable of being used by way of guidelines for clinics to make inquiries from GPs which might not be possible under the present circumstances if a person was informed, signed a form and agreed to go through with the procedure immediately.
I know that in the case of the late, lamented individual whose death precipitated this legislation. I suppose that he gave the GP's name on his form and that GP was not consulted. If the GP had been consulted it is quite clear that the individual would not have been deemed to be suitable. I hope now that there is a clear period of time of six days in many cases between when a person gives their consent and when they take part in the trial, perhaps the guidelines the Minister proposes to draw up will encourage clinics to use that time to do the maximum amount of inquiries to find out anything they can about the medical records of the people participating in the trials. I welcome the amendment.
Amendment agreed to.
Government amendment No. 9:
In page 9, between lines 5 and 6, to insert the following:
"(5) Unless otherwise provided for by virtue of the permission granted by the Minister under section 4 or of any amendment to that permission agreed to by him under section 5, a clinical trial shall not be conducted on any person within the period of 6 days after the day on which the provisions of section 9 (4) have been complied with in respect of such person."
Amendment agreed to.
An Leas-Chathaoirleach
Amendment No. 9a. is on the additional list.
I move amendment No. 9a:
In page 9, lines 38 and 39, after "otherwise)" to delete "unless provided for by the permission to undertake the clinical trial" and substitute "other than compensation for expenses actually incurred by the participant in the trial".
I anticipated that there would be a seconder present and on the assumption that the seconder will arrive before I conclude, I propose to move the amendment.
There has been much discussion about the question of payment. The Minister pointed out on Committee Stage a perception of specific circumstances under which it could be argued that people deserve to be compensated for discomfort, inconvenience etc. He had a point there but the problem for me, and the problem the Minister had to wrestle with also, is whether that set of circumstances could justify leaving in a provision for payment which could extend well beyond that. I have thought much about it in the meantime and about various amendments. My view would still be that it would be better to see how clinics could operate on the basis of truly voluntary participation by individuals who were not doing it to make money out of it. If it turned out that the clinics could not operate because of the fact that the pool of volunteers had dried up completely and all the participants had disappeared, we would have to look again at the question of payment or other possible methods of recruiting volunteers.
In the meantime I felt obliged to reintroduce the amendment which I introduced and withdrew on Committee Stage in the hope that between now and when the Bill has completed its passage through the other House, the Minister might look at this again and think about criteria for payment which would be designed specifically to exclude any form of incentive that would entice people who were on very low incomes to participate too frequently in these trials. I accept that much of what has been done in this Bill and the way in which it has been amended has restricted that.
I hope that in the meantime the Minister will consider tightening up further the whole basis for payment. In the light of much of the talk that goes on about social welfare recipients and their availability for work, the idea of social welfare recipients being locked up in a clinic for a week and still claiming social welfare assistance sounds to me to be utterly at variance with the principle that people must be actively seeking employment and available for work. If social welfare recipients faced the prospect of losing their unemployment assistance and the consequential prospect of having to wait six weeks before they got it back, that might be a considerable disincentive to get involved in these trials. This would be quite helpful. In this absence of my seconder all I can do is withdraw the amendment.
An Leas-Chathaoirleach
As the amendment is not seconded it falls.
Amendment, by leave, withdrawn.
Government amendment No. 10:
In page 9, to delete line 41.
Amendment agreed to.
Government amendment No. 11:
In page 10, to delete lines 1 to 3.
Amendment agreed to.
An Leas-Chathaoirleach
Amendments Nos. 12 and 13 are related and may be discussed together.
Government amendment No. 12:
In page 10, between lines 4 and 5, to insert the following:
"(a) in respect of any place under his control which the Minister reasonably believes is being or has been used in connection with the trial, permit any person, duly authorised by the Minister, to inspect such place for the purpose of determining whether or not the permission to undertake the trial is being or was complied with,".
Senator Brendan Ryan suggested during the course of Committee Stage that a provision analogous to that in the cruelty to animals Act namely that relating to the power of inspecting premises was appropriate to this Bill. I have carefully considered the matter and the additional paragraph now proposed in amendment No. 12 will make it clear that such inspections may be carried out.
Amendment No. 13 inserts the words "or any person duly authorised by him" after the words "the Minister". This is necessary to make it clear that an inspector, under the provision referred to in amendment No. 12, may request information which it appears appropriate to him to request at a time of inspection without returning to the Minister with a specific request.
It it perfectly clear that "his control" which is referred to in the amendment refers to the person who conducts the clinical trial and not to the Minister? Otherwise I am happy with the amendment.
Amendment agreed to.
Government amendment No. 13:
In page 10, line 6, after "the Minister" to insert "or any person duly authorised by him".
Amendment agreed to.
Bill received for final consideration.
Question proposed: "That the Bill do now pass."
I compliment the Minister on the Bill as it is now written because it contains substantial protections for groups in society who were perceptibly vulnerable. It contains reasonable protection for the medical profession in the light of the Minister's amendments. As a Member of the Seanad who is used to Bills coming from the other House with impatient Ministers who are fed up with Committee and Report Stages it was a pleasure to participate in the debate. I compliment the Minister on his response to this House and I compliment the Members of this House on the work they put into this Bill. It is well worthy of the time the House has devoted to it and I will be interested to see if the other House produces any more amendments.
I should like to thank this House for passing the Control of Clinical Trials Bill, 1986. This House and the Minister have done a good number of days work in bringing the Bill to the stage it is now at. The Bill leaves this House a very different Bill from what was originally produced by the Department of Health or by the Minister. It leaves this House a much better Bill than it was previously. Our thanks are due to the officials of the Department of Health who are responsible for it and to the Minister for the efforts he has made to deal with the very many concerns Members genuinely had not just on behalf of the medical profession but also drug companies and those individuals who were facing clinical trials who in the past in some instances had been taken advantage of. It has been a very worthy piece of work and if the public realise how flexible and helpful the Minister has been it would do him a great deal more good than he realises.
It is important to stress the point that this House has been discussing 40 per cent of all legislation in recent times in the first instance. This is yet another Bill which has been initiated in the Seanad and we should be grateful to the Governemnt that the House is being treated in this fashion.
I thank you, a Leas-Chathaoirligh and your colleagues in the Chair for the assistance you have given to us in enacting this measure. We have had a difficult period of conjoining many amendments and discussions on Committee Stage but it was done most expeditiously. I want to thank Senator Sean Fallon for the manner in which he facilitated the proceedings of the House in taking the Bill and, in particular, two other Senators who contributed enormously towards the development of the Bill, Senator Alexis FitzGerald and Senator Brendan Ryan, because it is and was a complex piece of drafting. We had very little help within Europe or the United States by way of parallel legislation available to us, but the work was done and a substantial number of amendments were adopted by the House.
Finally I would like to thank the medical profession, the pharmaceutical profession and the National Drugs Advisory Board officers for their exceptional representations in the course of discussions on the Bill. It would be entirely remiss of me if I did not thank the staff of the Department of Health who faced up to the problems posed by this Bill and did so with exceptional diligence and a great deal of competence. I am very pleased that the Bill has been enacted and I hope to be back here in the New Year with a few controversial matters. I have quite a number in mind.
Arising out of your parliamentary party meeting today there is one measure which the Seanad could very usefully deal with.
An Leas-Chathaoirleach
You are not supposed to know what comes out of parliamentary party meetings.
Question put and agreed to.
