I do not think that is the one you object to, Senator Ryan.
Control of Clinical Trials Bill, 1986: Committee Stage (Resumed).
Debate resumed on amendment No. 39:
In page 7, between lines 25 and 26, to insert the following subsection:
"(5) Every person shall, before giving his consent under this section, fully disclose all drugs and medication taken by him within the previous six months".
—(Senator Fallon).
I never object. I might have quibbled but I never objected.
I want to express support for Senator Fallon's amendments. Like Senator Brendan Ryan, who spoke on it immediately before the House rose when the Minister went to vote, I see that there is a certain degree of difficulty in trying to enforce this. Senator Fallon says that every person shall "fully disclose all drugs and medication taken by him". How can one ensure that the person is going to tell the truth? Nevertheless, it would be a good idea to question them about that. It should be made clear to the people involved that there are dangers in undertaking a clinical trial of this kind if they are already taking other drugs or medicines.
With regard to Senator Fallon's second amendment, in this day and age of computers and gathering of information there should not be much difficulty in having some kind of system whereby there should be a record of persons undergoing clinical trials so as to ensure that they do not go from trial to trial without any great gap in between in an effort to earn more money. There is much peculiar information gathered in various computers under the auspices of the special branch or under the auspices of various departments. If there is computer data—as has been suggested in a national newspaper recently — on all members of Irish CND because they are automatically considered to be subversives, it should not be beyond the wit of man to set up a system whereby data can be kept on the people who take part in clinical trials. I support Senator Fallon in what he is aiming at in these amendments.
As I indicated, the purpose of the two amendments is a matter which is the responsibility of the ethics committee and the people arranging the trial. It would be impossible to spell out in detail in the Bill every aspect which should be inquired into. There is the difficulty that if one were to allude to all of the contingencies one might find oneself in the situation of over-definition. The general responsibilities of an ethics committee for considering the justification for a trial, which are included in section 7 (2) and (3), together with the provisions of section 7 (4) (c) and (g), are adequate. I would point out that applications to the Minister must include details of the criteria for the selection of participants. Under the guidelines which we will be bringing into operation for the committees these details would be encompassed by that provision. Therefore, I consider that details of this kind are more relevant to the guidelines about the operation of these trials.
Is the amendment withdrawn?
Reluctantly. The amendment was to create an awareness of the likely outcome of situations like that.
Amendment, by leave, withdrawn.
Amendment No. 40 not moved.
Government amendment No. 41:
In page 7, subsection (6) (a), line 40, after "illness" to insert "and where the consent is expressed in writing and is attested by the signatures of both witnesses".
Amendment No. 41 is in line with the general requirement that consent should be expressed in writing. Accordingly, it is inserted in that section.
Amendment agreed to.
Government amendment No. 42:
In page 7, subsection (6) (b), line 48, to delete "in a position" and substitute "competent".
Amendment agreed to.
I move amendment No. 43:
In page 7, subsection (6) (b), line 49, after "participation" to insert "and in forming that opinion the ethics committee shall satisfy itself that the person so consenting is capable of comprehending the nature, significance and scope of his consent".
My amendment relates to a situation as in section 8 (6) (b) which states:
where such a person is capable of comprehending the nature, significance and scope of a consent to be given for the purposes of this section, that person may be a participant in a clinical trial only if written and signed consent is given for such a participation by a person or persons...
The Minister has substituted the word "competent". I suggest that the word "competent" is a little weaker than the committee ensuring that the person is "capable of comprehending the nature, significance and scope of his consent". I know the Minister is going to say that the Attorney General and the parliamentary draftsmen have assured him that all the things I suggest in my amendment are contained in the word "competent", and we could spend a long night arguing about whether or not that is true. I will sit down at this stage because I do not think there is any disagreement in principle between myself and the Minister about the idea that whoever gives the consent should be somebody who is not only legally entitled to do so but is capable of knowing what he or she is doing in giving that consent. I should like to hear the Minister's views on that. Without any great brilliance I can foretell what he is going to say.
As the Senator rightly said, we both share a common view on this general principle. I have checked the phraseology quite carefully and there is no doubt that the term "competent" is regarded as the appropriate legal term to put in.
Amendment, by leave, withdrawn.
I move amendment No. 44:
In page 8, subsection (7), lines 7 and 8, 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".
This is an amendment which, unless the Minister is extremely forthcoming, is unlikely to be withdrawn because it defines a philosophy on how clinical trials ought to be conducted. The present provision in the Bill under section 7 (4) (h) is that the ethics committee must make itself aware and consider "details of any proposed inducements or rewards, whether monetary or otherwise, to be made for becoming or being a participant;...". Section 8 (7) provides that:
No person shall offer or cause to be offered to a person for becoming or being a participant in a clinical trial any inducement or reward (whether monetary or otherwise) unless provided for by the permission to undertake the clinical trial.
They are the two references I could identify to payment in this area and I am, therefore, extremely concerned that the principle of what are regarded as acceptable levels of payment has not been dealt with further. I am aware that there are differing views on this. I have thought much about this and I have concluded that the only way to ensure that people are properly protected is to provide that no payment should be given — this is what my amendment suggests —"other than compensation for expenses actually incurred by the participant in the trial".
The Institute of Clinical Pharmacology have a nice little piece about what they call "expenses — remuneration" as if they both mean the same thing when they mean entirely different things. One implies, at least, compensation for expenses actually incurred; the other is a form of payment. They say: "These are based on the minimum industrial wage and are essentially the same for all studies, on a per diem basis”. They have a nice little piece about how some people in the past said they were paid too much and others said they were paid too little when “the total amount paid relates to the duration of the study”. That sounds quite restrictive.
On the other side of it, in a submission from Elan Corporation in Athlone there is a quite enthusiastic piece about the contribution to the local economy. They say:
The approved recompense to subjects volunteering for essential studies in Elan's Clinical Pharmacology Unit stimulates the local economy by increasing the disposable income of these individuals.
While I got the impression that the Institute of Clinical Pharmacology are trying to play down the significance of remuneration as an inducement to people to participate in trials, Elan seem to be making the point that this payment is actually effectively a form of wages, a contribution to wages and something that actually stimulates the economy.
That introduces a distinct stench of exploitation into the whole area of clinical trials. Let me remind the House that the basic rate of unemployment assistance for a single person is in or around £34 or £35 a week. To specify a level of payment that is not a significant inducement to unemployed people or people on very low incomes to do something they would otherwise not do would make the payment so low as to be derisory. Remember £2 a day to an unemployed person represents roughly a one third increase in their weekly income. It is £10 a week which is slightly less than one third of weekly income and £2.50 a day is more than one third. That is a derisory sum of money but it is one third of an increase on the income of an unemployed person. If you give a rate like that when you are dealing with unemployed people it is still a huge amount of money. If a larger rate is specified to persuade people who are employed to take unpaid leave to do it, you are increasing the inducement to unemployed people, to people who are down on their luck and people who are short of cash to do this. It goes back to what has been the experience in parts of the United States in the area of blood donations where, because people are paid as blood donors, the most wretched, most deprived and most depressed people queue up to donate yet another pint of blood for the X number of dollars they get for it.
I do not think the principle of volunteer clinical trial participants can be dealt with unless the idea of payment other than for expenses incurred is eliminated. They would include expenses incurred — I am prepared to be quite broad about this — by people who have to travel, because arrangements have to be made to look after children, or they have to get alternative people to work for them. There is a case to be made for encouraging people as volunteers to participate in trials like this, if they are not just being done for what are, effectively, two large major multinationals, and they have the most high profile. They are not the only trials going on.
In the general run of clinical trials conducted in hospitals around the country, there is a very good case to be made for encouraging people to volunteer. It is a risk, perhaps, but it is a risk which contributes substantially to the wellbeing of the community. There is a major problem when you are talking about two major, wealthy and profitable multinationals like the ICP and Elan. Apart from ICP and Elan we must encourage people to participate. Encouraging people to participate as volunteers and ensuring that they do not incur any loss of money because of it is a totally different thing from imagining you can fix a rate which does not become an improper inducement to some people. Given that we have a huge pool of unemployed people who now see no prospect of any alternative source of income, any level of remuneration will become a quite substantial inducement to participate not just in one or two clinical trials but in as many as the person can get involved in.
I already quoted the case of one person who talked about doing six trials in nine months. I quoted from The Sunday Press of 2 December 1984 on Second Stage the case of an individual who, in the course of three years, completed around 12 separate courses at the institute earning fees from £150 to £1,200 per course. This was back in 1983. There is apparently a preception that considerable sums of money can be “earned” by undergoing these trials. Clearly, what we are going to get is people being induced to do these trials because of the prospect of a substantial increase in what would otherwise be a very miserable income. You either think that is a good idea or you do not. I believe there has to be a better way of recruiting volunteers and getting people to volunteer to do these things other than by actually paying people. Therefore, the only remuneration that ought to be involved is remuneration for expenses actually incurred.
This raises a very interesting question about unemployment — given the enthusiasm of certain people in this House and the other House to deal with social welfare abuse — as to whether people who are unemployed and doing clinical tests are available for work. If they are not available for work have the Department of Social Welfare ever made the slightest effort to find out why they are not available for work. People who are locked up doing a clinical trial for two days or a week are clearly not available for work and not actively seeking work. I do not know of any evidence that they actually lose their unemployment assistance or whatever other sort of benefit they are on. That is a peripheral issue.
The central issue is the philosophical question of whether people should be paid for doing these trials. I have discussed this with many people and I do not see any way of preventing exploitation of people who need whatever little amount of money is being paid other than to eliminate the whole idea of payment and to replace that with a reasonably generous level of expenses based on the expenses people actually occur. I put down amendment No. 44 which proposes to delete the words "unless provided for by the permission to undertake the clinical trial" and substitute the words "other than compensation for expenses actually incurred by the participant in the trial". Section 8 (7) would then read: "No person shall offer or cause to be offered to a person for becoming or being a participant in a clinical trial any inducement or reward other than compensation for expenses actually incurred by the participant in the trial".
Whether the payment to volunteers is described as expenses or remuneration, it will always be very difficult to get agreement on what are acceptable levels of payment. No matter at what level the payment is pitched there will be some who will argue that the payment is so high as to constitute an inducement or a bribe. On the other hand there will be those who will argue that the payment is so low that the participant is being exploited.
The practice of paying a fee to participants in clinical trials has been in existence for some time. When a practice has been in existence for a certain length of time, it comes to be accepted as the norm. Therefore, it becomes very difficult to vary that practice to the detriment of the persons affected by the varying of it. The Government are discovering this in the other House in relation to the Christmas bonus for social welfare recipients. The levels at which fees for clinical trials to participants are pitched in Ireland at present are reasonable. I would not like to see a situation where payments would be made on the basis of expenses because that would mean there would not be a flat rate payment to the participants and some participants would receive more than others. This would lead to considerable unrest. I have grave reservations about Senator Ryan's amendment.
I would love to support Senator Ryan's amendment. He is suggesting participants should get some form of out of pocket expenses as distinct from what they actually get at present. I do not think it makes any difference whether they are called expenses, financial expenses, financial recompense, inducements or whatever because at the end of the day what matters to those people who go on these clinical trials is what they get when they leave the trial. If it not sufficient they will not go. I would love to think people could participate in clinical trials for expenses — assuming the expenses would be much lower than what they are getting at the moment. The social policy action group suggested they should not be pitched higher than the weekly supplementary allowance which is something in excess of £30.
I went out to the ICP and met people on arthritis trials and heart trials. I went twice to Elan without telling the people. I just walked in and chatted to the lads. I know many of them and, unfortunately, most of them are out of work. Some are employed but on very low wages. Some of them are students. The common denominator in all cases was that they were there for the financial rewards. They knew exactly what they were going to get. It was spelled out for them before they went on the trials. Some of these people have helped me at election times. I asked them would they go on trials for the £31 or £34 a week supplementary welfare allowance and they made it clear to me there was no way that they would participate in a trial for that kind of money.
In a perfect society we should all be doing trials but for these trials you have to leave your family for three or four nights at a time. You might be there for the full week-end depending on the trial in question. Even in a hospital scene where they are well fed, have television and pool, people involved in clinical trials feel that because they are away from their wives, sweethearts and families they are entitled to the money they get at the end of the trial. As I said, in a perfect society people would be doing trials for expenses. We should all be doing them for expenses but we would not have the time or the interest to participate in a clinical trial for four or five nights at a time.
If Senator Ryan presses this and the Minister agrees to it, it is the end of clinical trials. It is a sad fact but it is true. You may say goodbye to clinical trials if they are pitched so low as to make them unattractive. At the end of the day clinical trials are for social welfare recipients and those on low wages who are saving up to pay an ESB bill, to buy a television, or whatever. They are there for the money and 99 per cent of them will tell you that. They will say they are happy in the knowledge that medical research is being fostered and improved and happy to be able to help somebody else. At the end of the day it is what they get that matters.
You cannot pitch the payment too low or too high because obviously if it was pitched too high, you would not know what the results would be. People might tell lies to get on a trial for big money. It has to be pitched at an acceptable and reasonable level. If the Minister decides these people should get expenses only, you can say goodbye to clinical trials. I checked this out very fully during the summer months with people I know well who have been on these trials. They will not participate for expenses, or call it what you like. They know exactly the kind of money they are entitled to. They will go if they get that money. If they do not get that money they will not go.
While I appreciate what Senator Fallon said, unfortunately it lays bare the whole crux of the matter. I hasten to say that I am talking principally about the recruitment of so-called healthy human volunteers for trials of new drugs being carried out by or at the behest of pharmaceutical companies. I am not talking about the sort of clinical trials that are carried out in hospitals on patients who already need treatment for illness and so on but about commercial trials of drugs. This is the inherent difficulty in that, on the one hand, we are being told that it does no harm, that it is a splendid thing to do and that it is something for society but, on the other hand, we are being told the real truth is that it is something nobody in his right mind would do unless he was rightly paid for doing it. This seems to be the crux of the matter.
I am a little concerned to think that if we had a system, as some parts of the United States have and indeed some countries in Europe have, whereby people were paid to give blood, there would be people standing up here today saying: "Who would go in and give their blood for nothing if we took away this system of payment?" Yet here and in Britain and other countries we are able to manage a perfectly good blood transfusion service without offering payment to people. In a sense what we are saying is that we must pay people to do this because it is something that none of us would do if we could possibly manage not to do it. That begs the question that people who volunteer to do this are in need. What Senator Fallon says bears this out. People who are doing it are largely people who are out of work or on low wages and need extra money. When we are offering payment to them we are offering them a temptation which says to them: "If you do this for us we are going to pay you".
Sitting suspended at 8.35 p.m. and resumed at 9 p.m.
On a parallel with the idea of blood transfusion, it would be infinitely more desirable if we could have a situation where people who volunteered — they are called "volunteers" for clinical trials — did so simply on compensation of expenses rather than on payment but if we are to talk in terms of payment and think of it as something people should be paid for, then they should be paid at a high level, something really worthwhile. If we are to say it is something we need to pay people for, let us make provision for them to be paid a substantial fee for undertaking these so-called voluntary tests.
How many of us would be anxious to volunteer as guinea pigs to have drugs tried out on us? If we looked into our own hearts, we would find that we would be fairly shifty about volunteering to put ourselves forward for these trials. So, if we are asking other people to do it and we genuinely feel we cannot run a system whereby no one will do it just for expenses, then let us offer a genuine inducement rather than a balancing act, saying we will just about pay them enough to tempt the poorest of the poor or the most deprived to apply.
I accept and I share the concern of Senators that greater care must be given to the framing of this section. I started out in the drafting of this Bill with a very rigid view in relation to the question of inducements. I had a great reluctance to be in any way associated with any question of inducement or reward of any kind. The more I examined it and the more I discussed it with reputable clinical arrangers, the more I saw that it would be preferable to rigorously control inducements. As a result we drafted section 8 (7) as follows:
No person shall offer or cause to be offered to a person for becoming or being a participant in a clinical trial any inducement or reward (whether monetary or otherwise) unless provided for by the permission to undertake the clinical trial.
I discussed this matter with the Attorney General and with the parliamentary draftspersons and the legal advisers of the Department of Health. We felt there should be a rigid provision whereby the body politic, the Minister for Health of the day, would determine what inducement may be offered, if any; to what extent expenses may be paid, if any; to what extent any moneys in addition to expenses may be paid, if any. All of that would have to be provided for.
It is true that one could write into the section that travelling expenses would be paid and we could have a system of compensation for loss of wages and loss of means or hotel expenses where a person may be travelling to and from a particular vicinity. One could define it on that basis. Nevertheless, one would finish up with substantial problems of definition and of encompassing arrangements.
For example, there are many pharmacological studies which entail very lengthy presence on the part of an individual and would require very tedious arrangements on the part of the individual — perhaps going on over several weeks of residence — with the person being obliged to be totally free of tobacco and totally free of alcohol and agreeing to do regular urine tests three or four times a day. That could go on over a protracted period. The person would be provided for by way of accommodation, meals and general recreation in a setting which would be agreeable to the person. Within that framework, should one have a statutory prohibition that such persons should not receive any payment whatsoever or a payment which would be the equivalent of a social welfare payment, either a minimum payment or a medium payment or a special payment if the person had a dependant and so on?
How does one define it? It is very difficult. There can be the question of sheer personal inconvenience — nothing more, nothing less. Is one to deny a person a particular remuneration for incurring that personal inconvenience? Some trials may have an element of discomfort. As we know, payment cannot be made and should never be made for risk, but there can be a degree of discomfort — it may not be major — but is one to prohibit payment in that regard? For example, a blood sample may be taken every day or every two days or at the end of every period as agreed. That is a matter of discomfort. Is one totally to prohibit payment in that framework?
These are very difficult questions. They are questions which we cannot easily deal with. I am very interested in the views of Members of the House. I have an open mind on the question. I framed the Bill on the basis that inducements must be controlled. They must be specifically provided for in the proposal, must be stipulated in the permission given and adhered to. Anything in excess of that would result in a prosecution.
We come to the conclusion that we will have to consider carefully any proposals. I accept and share Senators' concern about an undue inducement. However, in the case of a trial which involves considerable inconvenience to the person I am loath to say that the expenses should be the same as those for a trial which involved no inconvenience at all. I would be interested in the further views of my parliamentary colleagues on the matter. This is the best we could frame. Unless I had some alternative which, frankly, I do not see, I would be constrained to indicate that the section as drafted should stand. I will leave it in that setting at the moment. The question arises as to whether some recompense should be allowed for particular features of a trial, such as restriction of freedom of movement.
The most important single thing about the Bill is that the Minister will now be able to exercise statutory control over the level of such inducements. I would be loath to have a total blanket prohibition on payments other than expenses directly involved. I am very concerned about the matter and I have approached it with a great deal of caution and concern.
I am troubled by this area also. I tend to weigh very seriously the concerns expressed by Senator Ryan in moving his amendment. There is a very real worry that we would, in this Bill providing a whole method of administering and controlling clinical trials, give a statutory licence for exploitation of people in our society who are very vulnerable. We know the kind of people who are vulnerable and likely to seek to participate in clinical trials purely because of the inducement offered, either monetary or inducement in kind.
One of the problems I have in assessing and weighing the alternatives is an absence of an adequate information base about the situation on the ground. I can envisage a number of instances where you could have clinical trials without difficulty. You would obtain what we are calling the healthy volunteers, without difficulty, in a hospital context, in a medical school context, where either staff or students would participate, as they do regularly participate in that kind of clinical trial. It would be helpful if we were narrowing our focus on the circumstances where it would be likely that monetary inducements of a kind would be offered. When we do that, some of the objections Senator Ryan has voiced become more evident because it then becomes clearer that inducements are being offered to people to encourage them to participate for monetary reward, monetary gain, monetary need in this type of trial.
That may not be the best basis on which to recruit people to participate because you are targeting in on a particular sector and it can lead to exploitation. If the legislation is to leave it open by the provisions of section 7 (4) (h) and by this section — if Senator Ryan's amendment is not accepted — to offer monetary payment as an inducement, then surely we should insure that that is at a very high level. Surely we should actually put in a minimum requirement of either so much a day or so much an hour to make it absolutely clear that if monetary inducements are being offered they would be very substantial. That would have an interesting effect on the proposers of clinical trials. For the first time they might actually consider very seriously the way in which these clinical trials are conducted.
It would also have the beneficial effect of very high minimum payments for the persons who had to suffer the discomforts the Minister was describing — spending three or four nights away from home, giving up smoking or whatever. Those offering would be required to take the whole situation onto a new plane and by so doing in effect one would at least avoid some of the exploitation. It may be that there would be a very substantial queue to participate. That in itself would increase the pool of potential participants if one is doing it on a paying basis. It is a question of really thinking through the implications. If it is on a paying basis then we should, as legislators, be insisting on a very high minimum payment for participation and that would take some of the worries out of the system. The alternative proposed by Senator Ryan in his amendment is that it would not be on a paying basis.
I have one concern with a legislative prohibition on any payments other than expenses, that is, how it would be enforced. I would be concerned at the possibility of hidden inducements and the real difficulty of policing them. Senator Fallon has said he knows of a number of people who seek to participate and only do so on the basis of the monetary return to them. If by accepting Senator Ryan's amendment we prohibit any payment other than what Senator Ryan has made clear would be generous expenses, then there is a real concern that this would simply be by-passed by covert payments which were never acknowledged. Those receiving them would be prepared to go along with that because they are vulnerable. They would be prepared to accept payment on the basis of its not being declared and never going before the ethics committee and so on. We could be into a worse situation of exploitation. Of course, if somebody is caught at it, it could be a ground for revoking the clinical trial, but it might be quite difficult to police. This is a difficult area.
I come back to my initial point. We really do not know enough in this House about the present situation in relation to those who participate. Like Senator McGuinnes, I emphasise that we are really talking about healthy volunteers at this stage. We are talking about those who voluntarily participate in clinical trials. There is the contrast between those in a medical school or hospital context who can be persuaded to do it for reasons of advancing the trial itself, advancing their knowledge, advancing medical science, and the alternative, a pharmaceutical company which wishes to do a clinical trial on a substance and is therefore seeking to obtain volunteers to participate.
Having raised a number of the difficulties I still lean substantially in principle towards Senator Ryan's amendment. When we are setting up a legislative system we should seek to do so on the basis of not providing monetary inducements which would become exploitative of certain people in our society. We could ensure that the kind of expenses did take into account discomfort of the kind that has been described, or segregating yourself from your family for a certain period, or undergoing that kind of discipline in the course of a clinical trial. That could be reflected in the measure of the expenses. The point is a very important one and it really is the litmus test of how we do approach clinical trials and where we place the emphasis. If we place the emphasis substantially on protecting the public and, in particular, protecting vulnerable sections of the public, we should not be permitting through the legislation and authorising payments for participating because of the dangers involved.
The last hour of debate has been of a quality that deserves more wide appreciation than this debate will actually get. It has been a very serious discussion. I do not think there is anybody in the House who is in any way differing on the principle of a profound concern that people should not be exploited.
It was helpful and constructive of Senator Fallon to say that people are undergoing clinical tests for money. If that is the case, we can do two things about it. We can either say it is unacceptable in principle that people should undergo clinical tests for money, or we can see to it that people are paid sums of money which represent real substantial earnings on their part and which probably of themselves would be a substantial disincentive to those running the trials to get involved in excessive numbers of trials. By substantial payments, I mean payments on an hourly basis of at least twice the average industrial hourly wage. There is also a distinction to be made between the two major profit generating companies which conduct clinical trials on a systematic basis and the many hundreds of other clinical trials conducted by hospitals and other bodies on a limited basis, with a limited number of people, for reasons other than profit to the institution or profit to the individual.
There are two very different forms of trials involved. As far as the two major companies are concerned, my view is that if we cannot prohibit payment, there is no safe intermediate position. We should either prohibit payment and restrict it to the expenses actually incurred, or alternatively we should pitch the payment at a level which makes large numbers of people interested and which, in the process, will compel the company to take a representative sample of society and thus eliminate the risk of exploitation of people. It is not the idea of doing trials that exploits people. It is not the idea of being paid for doing trials that necessarily exploits people. It is the idea that people feel compelled to do something they would otherwise choose not to do because of the money. There are other forms of exploitation. There is the suspicion that covert payments will be involved. Senator Robinson mentioned that and I agree with her. Do we, as Members of the Oireachtas, believe that the bodies running clinical trials on a commercial basis are capable of that sort of activity? I have a considerable amount of evidence that they cut corners and have done so in the past. The inquest to which I have referred suggests that on many occasions a lot of the noble principles espoused were far from rigorously enforced when pressure came on, for one reason or another, to get a trial done quickly. If that is so, there is a strong case for not allowing these things to be done at all.
If we are not satisfied, we can regulate them, organise, control and police them in a way which prevents all the things we want to prevent being carried out or implemented. I am acting on the presupposition that we will be able to regulate them properly and that this legislation will see to it that they are regulated properly. If they are regulated properly we can eliminate the risk of covert payments by a variety of means including the simple question of finding out whether the people who do the trials are getting covert payments. One presumes that the response of a Minister to that particular activity would be to refuse all further permissions and that, effectively, would close down the company.
The Minister sympathised with the case I put forward but he seemed to be at a loss to do something about it. If you tease out the principles involved here, it is possible to talk about an alternative form of words. What I would have in mind is something which, first of all, incorporated what I had proposed as the basic principle; that in general nobody should be paid anything more than the reasonable expenses incurred. Secondly, an exception could be made where bodies conducting the tests are profit orientated bodies doing these tests on a commercial basis. In exceptional circumstances the Minister could approve payments in excess of the expenses incurred where he was satisfied there was justification for it. That would mean the rule would be no payments, but exceptions would be permitted where the Minister was satisfied.
This is a matter of whether we are prepared to incorporate in legislation the seriousness with which we take this issue. The way to do it is to state a principle which is that no payment, other than expenses, should be the rule but that the Minister should be authorised to permit exceptions to that rule where he is satisfied. That would have to be done in the individual application for an individual trial where a case could be made that there was a level of inconvenience or discomfort involved but this is perhaps something we could discuss outside the House. That would be the sort of suggestion I would make. If we are not prepared to eliminate payment completely and if there are limited circumstances where the inconvenience and other things are justified, perhaps the way to do it is to state a general principle of no payment and make a proviso for the Minister to identify exceptions.
I am sure the Minister will say that that is not very different from subsection (7). To do it in that way would be to identify the principle which the Oireachtas regarded as being the necessary principle on which this process should operate. We are agreed, judging by the seriousness of the debate and the detail in which we have debated it, that this is a very fundamental, philosophical question in the whole issue of clinical trials. We should talk about it in terms of what principles we want incorporated in legislation. When we are talking about inconvenience and discomfort, it is important to remember that people who give blood in blood transfusion clinics are suffering inconvenience and are suffering discomfort. They are asked to be careful about their diet and the things they do for a short period afterwards. They are asked to avoid certain things and they do it for no payment or compensation.
I agree with Senator McGuinness that, if we were to be presented with a case in relation to blood donations and if we were a society where people were paid for them, we would hear many of the same arguments that we are dealing with here tonight.
In conclusion, and before I decide what to do with this amendment, I should like to hear whether the Minister has any interest in my suggestion that the principle should be no payment with a provision for the Minister to authorise payment where he believes exceptional circumstances permit it. In the case where payments are to be made, the payments should be sufficiently generous to ensure that people are not induced even onto those trials for small sums of money. The ICP suggest that the rate of payment used is what they call the minimum industrial wage. I do not know what the minimum industrial wage is but I know what the average industrial wage is. There are two different rates; there is a female rate and a male rate. If there is to be payment it should be of the order of twice the average male industrial wage rate. We should incorporate the principle of nonpayment as the principle in the Bill and make provision for the Minister under exceptional circumstances to permit payments in excess of those.
I have a continuing difficulty in meeting the situation. It is arguable that if the payment was twice the male adult industrial wage for transportable goods industries the whole country would be taking holidays to go on trials of a minor nature. There is this problem.
I am reluctant to be drawn into analogies such as blood transfusions and so on. After all the giving of blood or the selling of blood, obnoxious as it would be, is very different from the acceptance into oneself of a foreign substance of unknown therapeutic components and effects. It is difficult to draw analogies of that nature. There is not a great deal of direct information available in relation to the matter. The Royal College of Physicians of Ireland in a publication in January 1986 made a point regarding volunteers and I quote:
Ethics Committees should be informed of all proposed payments to volunteers and should be satisfied that they are reasonable and not so large as to induce subjects to take risks primarily for a reward.
I tend to share that view. It is interesting to note that, for example, Professor Kevin O'Malley who is the current chairperson, by appointment, of the National Drugs Advisory Board, is one of the people who signed the working party report as did many other distinguished members of the College of Physicians. But that is a broad guideline. What we have put into the Bill is much more rigorous and more controlled. In section 7 (k) we repeat the strictures specifically for the work of the guidelines, namely, that any payments, monetary or otherwise, to be made to any person for facilities used for the purposes of the clinical trial must be taken into account and then any payment, monetary or otherwise, to be made to a person for conducting clinical trials or any part of the trial, must again be taken into account. All the criteria are there and there is the section itself which is as tightly drawn as we could possibly manage.
The recent report on research on healthy volunteers by the Royal College of Physicians of London, Volume 20, No. 4, of October 1986 made the point about financial and other inducements and I quote:
...many studies, particularly in pharmacology, are lengthy and tedious, and may involve urine collection, multiple venepunctures or other procedures associated with some discomfort. It is reasonable that volunteers in this type of research should be paid, over and above reimbursement of expenses incurred. These payments are for inconvenience or discomfort and increased payments may be reasonable for procedures requiring extra care on the part of the subject or involving more discomfort.
Payments should never be for undergoing risk. Payments should not be such as to persuade people to volunteer against their better judgement, nor to induce them to volunteer more frequently than is advisable for their own good. While appreciating that any given sum would be viewed differently by a student or person who is unemployed than by a person in full paid employment we suggest that payment should range somewhere between rates equivalent to current student grants and a daily equivalent to the average wage, but time involved and inconvenience incurred should be taken into consideration. All payments to volunteers should be approved by the Ethics Committee.
They are quite clear on that and also they make it quite clear and I quote further from the report that:
When a volunteer withdraws for medical reasons related to the study full payments should be made. When the volunteer leaves the study and exercises his right not to give a reason or is required to leave for non-compliance, no payment need to be made if the consequences of leaving the study in these circumstances have previously been explained to him. If a volunteer withdraws for other reasons, including non-related medical reasons, the investigator or sponsor should make a proportional payment.
Some investigators receive personal payment, or members of their staff, the department, or laboratory equipment may be funded by a sponsoring company or other organisations.
That is quite a common occurrence and these payments should also be disclosed to the ethics committee. This is commended in the Royal College of Physicians report.
Overall there are multiple reasons why the position can vary. I am comforted by the fact that Senator Robinson brought out the complexities involved in assessing the acceptability of particular payments. She stressed the difficulty of phrases such as "expenses" and confining it exclusively to a phrase of that nature. The safeguards that we have of first satisfying the ethics committee about the level of payments and secondly that the Minister must in turn be satisfied that the level of payments which would be disclosed as payments has to be formally recorded departmentally and by the ethics committee. The National Drugs Advisory Board who would be very much involved in the general advice and guidance would be aware of the amount of the payment. If people felt they were being shortchanged they would not be too slow in coming forward. Where a company made an effort to offer an inducement which was away over the odds for reasons of doubtful propriety this would become known in time. If you have total blanket prohibition there is the real problem of the underhanded payment of expenses. We all know how insidious and appalling that can be.
Overall I am inclined to stick to my views and if, between now and Report Stage, we and in particular our academic colleagues who are familiar with that area of compensation, have any views which could be brought forward I am quite willing to have advice sought again from the National Drugs Advisory Board. Between now and Report Stage I will be quite willing to listen to the views of any of the medical colleges who have particular views and indeed, the views of individuals. I would like to receive information. The volume of actual information as to what precisely happens is not very great. I would be glad to have that. I would certainly consider it and I would be prepared to meet Senators on an informal basis to have a look at that section if they feel it must be amended in a particular formulation.
I would go so far as to say that our colleagues in the Department would be available to discuss the position with Senators on an informal basis. I have an open mind. This is the best I have been able to draft at this stage because there is no statutory legislation in the UK or on the continent to which I can readily refer.
I find the Minister quite persuasive on this issue. My intention was to press this amendment but one should never press an amendment when the door is even one centimetre open not to mention when the door is reasonably wide open. Consequently, even though I appreciate that the Minister has made no commitment to do anything, I would prefer to have some time to think about it, consult with my colleagues and perhaps discuss it with the Minister, rather than close the debate now. Therefore, in the light of what the Minister has said and the obvious concern of everybody that we should work out a system which protects people from exploitation and meets the obvious occasional difficulties I wish to withdraw the amendment.
Amendment, by leave, withdrawn.
Question proposed: "That section 8, as amended, stand part of the Bill".
Senator Mullooly raised the question of the person who is consenting to a trial being informed of what the trial involves and having to be informed of the facts of section 8 (5) which reads:
Any person who has given his consent in accordance with this section may withdraw it at any time and no contractual liability shall be incurred by such person...
He suggested to the Minister that it should be specifically stated in the guidelines that a participant must be informed of that right as part of the process of informing him about the implications of the trial.
I indicated that I would consider that.
Just very briefly may I make a suggestion which might exclude from the body of helping human volunteers people who really should not be volunteering on account of their unfitness to do so and who might be tempted, supposing there is a fee paid, to volunteer in order to get the money. Would it be possible for the Minister to consider — I am not asking him to answer this question now — between now and Report Stage the possibility of allowing an independent body such as the Blood Transfusion Board to assemble a panel of applicant healthy human volunteers who could be vetted independently before they go to the people who are performing the clinical trials, and that it would be from this panel that people would volunteer and be accepted.
I have not thought this idea out very well but we could have an additional filter system to prevent people whose health condition should rule them out from being volunteers. It would be an independent body who would decide this rather than the people who are anxious to get volunteers because they are running the clinical trials and have a profit based interest in them. There should be some way of setting up a panel of people from whom volunteers could be drawn.
I will consider this matter between now and Report Stage but I think it would pose great problems.
Question put and agreed to.
Before we start on section 9, we have sat beyond our normal 8 p.m. because some interested Senators would not be available tomorrow. Do Senators wish to sit beyond 10 p.m. in order to make further progress? If not, it would be inappropriate to start discussing section 9.
When is it proposed to continue this debate?
It would be proposed to take it on next Wednesday. I was anxious that it should be finished this week in order to allow two weeks to elapse between the completion of Committee Stage and Report Stage. We have had discussion on two of the more critical sections of the Bill and if the Minister could start his Report Stage preparation process on those sections without waiting for the completion of Committee Stage, time would not be lost by postponing the debate until next Wednesday.
I think Senator McGuinness and I would agree to that. Before we adjourn I would like to say that I appreciate the manner in which the Minister has handled the debate. He has been most forthcoming and most responsive. Until recently the Seanad was not the House — and credit must be given to the Leader for this also — where much serious business tended to be done regarding legislation. I thank the Minister for his response both on Second Stage and up to now on Committee Stage. I am very happy with his response.
Progress reported; Committee to sit again.