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Seanad Éireann debate -
Wednesday, 3 Dec 1986

Vol. 115 No. 3

Control of Clinical Trials Bill, 1986: Committee Stage (Resumed).


I move amendment No. 45:

In page 8, subsection (1), line 10, to delete paragraph (a).

We have a problem generally in relation to the use of the word "insurance" in this Bill. I have had consultations with interested persons outside this House in relation to this matter. In amendment No. 46, which arises also, instead of the word "insurance" I have suggested the insertion of the words "or malpractice indemnity" because it is not sufficiently appreciated that doctors do not have themselves covered for insurance. The British Medical Defence Union looks after a considerable number of practising doctors at general practice or consultant level in this country. As I understand it, what is, in fact, in place is a malpractice indemnity. This matter has been tested in the courts in the United Kingdom wherein they ruled that the cover given to doctors is not an insurance cover in the strictest meaning of the word. To that extent there is a problem in the way in which this is described in the Bill.

The matter is more complex than that. The matter of insurance generally, as drafted in the Bill, is a little more complex than what I have just said. Doctors are not covered by way of insurance. They are covered by malpractice indemnity. This matter has been clarified by the courts in the United Kingdom which must have a bearing on us here. May I ask the Minister, in relation to this whole matter of insurance whether this has been sufficiently thought through? How does the Minister expect, even if there was insurance available — let us not bother for a moment whether it is called insurance or malpractice indemnity — somebody who intends to conduct a trial to get cover, of whatever kind it may be, for the person who will be presenting himself or herself for the trial by way of procedure in a hospital? How can the Minister expect insurance to be "up front" before the insurance company know the conditions under which the National Drugs Advisory Board would advise the Minister in relation to the particular trial to take place? There is a genuine difficulty there. No matter what form of cover is available for the doctor he is in difficulty and will not know the conditions which may or may not be insisted on, on the advise of the National Drugs Advisory Board and by the Minister.

I mentioned the World Health Organisation in my Second Stage speech. I understand a study of some importance has been transfered from institutions in this country to Belgium because of the necessity of obtaining insurance. That is something which the Minister will clarify in his own way. I understand that to be the case. It also seems to involve an insistence on insurance for all forms of clinical trials. This, of course, could conceivably include trials involving patients with terminal illness and studies involving hospital management in practical terms. We covered the point earlier in some detail in relation to the question of the terminally ill patient. That has been expanded on in some detail. The matter of insurance also arises here.

I gather from what you said that you are inclined to take Amendments Nos. 45 and 46 together. Is that right?

It seemed as though Senator FitzGerald was taking two amendments together.

I have no objection.

The question of insurance is a matter a number of contributors to this debate raised on Second Stage. It continues to be a problem. It came as something of a surprise to me — perhaps I should have known — that doctors do not in general carry insurance. As Senator FitzGerald said the medical profession would have malpractice indemnity but not insurance. When he is contributing to this debate on Committee Stage, it would be interesting to know whether the Minister is, in fact, insistent upon introducing quite a radical new development in this area, given that it does not apply in general to medical practitioners. They would not normally have insurance in relation to their work. They would have malpractice indemnity. I am extremely concerned about safeguards and about protection for those participating in clinical trials. I am not in any sense a spokes-person for the medical profession on this. That is not my concern. There would be a danger that we might be loading this in a way which would make it extremely difficult for clinical trials to be held. I do not think that would be good for the country or the overall objectives of this Bill. There is a very serious public interest in ensuring that clinical trials can and do take place because they are absolutely essential to the furthering of the important aims of advancing our knowledge, advancing the safety of drugs and appliances and so on.

I would like the Minister to address this issue of whether the Department, for whatever reason, are insisting on those conducting clinical trials — they need not necessarily be doctors, of course — taking out insurance even though it is accepted that, in the normal course, up to now, they would not have been taking out insurance cover in this respect. If the Minister is insisting on that, there must be a certain onus on him to explain to the House how this will be compatible with furthering the public interest in ensuring that clinical trials are held, in other words to ensure that it does not become an impediment to the carrying out of clinical trials in the way that it has certainly been put to me very seriously by members of the medical profession, by people in Trinity College, members of the academic staff in the medical school in whose judgment and assessment of these matters I have a lot of faith. They would have a broader view and not be simply trying to protect the medical profession from possible costs involved in an insurance policy.

As Senator FitzGerald has emphasised, what has been put to me — and I would like to hear the Minister's views on this — would be the very great difficulty of getting insurance cover, particularly in relation to terminally ill patients who would be involved in a clinical trial. There would be the difficulty of getting insurance cover — as Senator FitzGerald mentioned — prior to the permission to conduct a clinical trial because until the permission was forthcoming it would not be possible to assess the nature and scope of the risk. In some cases, particularly in the case of terminally ill patients, that would be extremely difficult and likely to be something for which an insurance company would require an extremely high premium. These seem to me to be reasonable questions. The concerns are worrying not so much because of the medical profession as such but in a broader sense because of the public interest in ensuring that we do not — while intending to provide protection — make it either extremely difficult or, in some cases quite impossible to carry out clinical trials. I would like the Minister when replying to indicate what the problems would be of resting on a requirement that a malpractice indemnity certificate be available. In what way is that considered to be inadequate as a protection? There are important issues here that we will have to examine in some detail.

As someone who is at present being sued by a person in Crumlin Road jail for the removal of a tattoo and an unsatisfactory skin grafting, I speak with some feeling in this area.

Does Senator Robb have insurance?

No. Senator Robinson raised a very important point. I am now speaking from the practical side because I had not thought through the implication of this until I heard her speak. As a profession we are protected either by the Medical Defence Union or the Medical Protection Society. On the whole they cover all doctors in the United Kingdom and, I believe, in the Republic of Ireland. When people are the subject of malpractice, negligent practice or whatever and they decide to take an action, we report this to the society which protects us. They then decide whether they will defend the case or settle it. But they are more or less obliged to give advice for the defence. They may fight it in court or they may not. They try, as far as possible, not to fight it out in court because invariably the publicity given to these things does not help the reputation of the person who has been involved. The difficulty I had in listening to Senator Robinson was that, up to this moment, I always thought that, were I involved in research of some sort, my medical defence union would protect me if an action were taken against me, or would attempt to defend me.

The other side of the coin is a different matter altogether. Increasingly, in recent years, one has found that more and more people are suing for damages in respect of accidents, very often very trivial accidents, in the expectation of receiving a fairly high rate of damages. I am sure the insurance companies, like many other people, have a vested interest in this whole business. Some people say other people get to the casualties in our hospitals before the doctors these days.

One has to be careful to weight up all these factors. We must realise that insurance cover comes into the picture — and I gather Senator Robinson's feeling is that we should look into this very seriously — there are a lot of vested interests in the whole insurance world. There is also good reason for trying to tap that interest on the grounds of malpractice. I have even heard of people — I will not cite particular instances — who are almost glad that something has happened to them because they know the person they can sue is insured. Therefore we must take all these matters into account. I agree with Senator Robinson that it is a very important area. It is not one to open up too lightly without thinking through the full implications of what we are at.

In view of the fact that the Minister has two amendments, one of which proposes the deletion of the words "issued by an authorised insurer" and the other the deletion of the words "and a copy of the policy of insurance has been supplied to the Minister", perhaps he would give us his thoughts on these amendments, Nos. 47 and 48?

We are hoping to take Amendments Nos. 47, 48 and 50 together. It is somewhat a separate subject. That might meet Senator Fallon's suggestion. I am in the Minister's hands. We have agreed to take Amendments Nos. 45 and 46 together. They are slightly separate from Amendments Nos. 47, 48 and 50. Does Senator Fallon agree?

Then the Minister on Amendments Nos. 47, 48 and 50.

I would welcome the Minister's thoughts on Amendments Nos. 47, 48 and 50.

Does the House agree that we should take all of them together? I have an open mind on it. We will leave it to the Minister.

Regarding the first point made that was on section 9 (1) (a), I do not have a problem if it provides greater clarity on the provisions of the Bill. If as Senator FitzGerald suggested, we delete subsection (1) (a), section 9 (1) would then read: "A person shall not conduct a clinical trial or administer any substance or preparation for the purpose of a clinical trial". The reason I would be prepared to amend that section is that of course permission to conduct a trial would have been given already. Therefore, the next step is the conduct of the clinical trial. It might read more effectively if we were to have the section read:

A person shall not

(a) conduct a clinical trial, or

(b) administer any substance or preparation for the purpose of a clinical trial.

To that extent I would be prepared to delete paragraph (a) for the sake of clarity and precision.

The second point raised was the question of indemnity. I am afraid I will prove to be very obdurate on that. We are not only concerned with malpractice, as such. We are, above all else, concerned with the effect on the participant of the possible intrinsic danger of the drug itself. That can have catastrophic effects on the participant. It may be entirely outside the clinical or trial competence of the doctor. He may be entirely blameless, but the impact of the drug can be quite dreadful. Therefore, one must insist that the paramount interest, which is that of the participant, should be given exceptional protection in this area. That is why I am concerned about that aspect. I do not think it is a central point but I am concerned about the conduct of trials on terminally ill patients.

A terminally ill patient is a terminally ill patient and, as such, using the doctor's clinical judgment in an effort to try to bring about a reversal, a doctor can competently maintain that the drug which is not entirely proven is available and, using his clinical judgment, he is prepared to take that risk. The patient's illness is deemed to be of a terminal character, is recorded as such and, therefore, he will take that risk. If the patient recovers, the patient is unlikely to sue him for malpractice, to say the least. On that basis the issue can be covered. I am prepared to concede the merit of the point made by Senator FitzGerald.

I will go on to deal with amendments Nos, 47, 48 and 50. Amendments Nos. 47 and 50 are necessary because the original provision required an insurer to hold an authorisation under the regulations of the Department of Industry and Commerce. These have been represented to me as being entirely too restrictive and would pose enormous difficulty. Accordingly, we have put down amendments Nos. 47, 48 and 50. Amendment No. 48 is being introduced because it is considered that it would be inadvisable for the Minister to have implied responsibility for confirming, in advance, that an insurance policy was adequate. He would find himself taking on the particular indemnity himself which, on reflection, would be somewhat unwise and he could find himself effectively facing the consequences.

These are the main reasons for putting down these three amendments. I think they will meet the general wishes of Senators while not in any way diluting the provisions of the Bill. We do not want to dilute the Bill but, at the same time, we do not want to make its provisions so restrictive that clinical trials, as such, could not be conducted under any circumstances. I will leave it at that. Perhaps Senators may have some further thoughts on the issues I have raised.

Is amendment No. 50 affected by the acceptance of amendment No. 45?

It collapses. I was going to make the point here that it seems to me that amendment No. 50 does not have any purpose once the Minister has indicated that he is prepared to accept Senator FitzGerald's amendment No. 45. One would expect that it would not be moved because it does not have any purpose. If the Minister is accepting Senator FitzGerald's amendment No. 45 to delete subsection (a), he does not have to define what is meant by arranging for the conducting of a clinical trial.

That is correct, as the Senator pointed out —

So amendment No. 50 falls?

We say in the section: "arrange for the conduct of a clinical trial" does not include any measures taken for the purpose of arranging a policy of insurance to which this section would relate. That is automatically effected.

With the deletion of paragraph (a).

Do I take it the Minister said he would accept amendment No. 45 but he would not accept amendment No. 46? Did I misunderstand him?

I accept amendment No. 45. I do not accept amendment No. 46.

We will have to put them to the House separately anyway.

It might be best if amendment No. 45 were withdrawn and I will propose an appropriate re-organisation of the section on Report Stage.

Now that we are all agreed on amendment No. 45, we do not have to address that amendment any more. It is appreciated that the Minister has accepted the basis for that amendment. But the more substantial issue remains which is the question of whether there is still a concern that the way in which this section is framed requires that a person conducting a clinical trial, a medical person, a dentist, persons authorised to conduct a clinical trial, must have insurance. Senator Fallon asked the Minister — and I join with him in asking the Minister — to clarify what precisely is meant by the type of insurance the section now requires. The Minister's own amendments, as he has explained, affect that. It is no longer a policy of insurance issued by an authorised insurer. It is no longer necessary that a copy of the policy of insurance be supplied to the Minister.

Is the Minister, in effect, using the word "insurance" in a non-technical way? Is it possible that a malpractice indemnity could be construed as being insurance for the purposes of the section at this stage?

Or a fund.

Or a fund of some kind. I share the Minister's concern that there can be consequences of a clinical trial which are not the result of malpractice, where a malpractice indemnity may not cover those consequences. That is a very real concern. I think I am correct in understanding that in Britain, for example, there is a policy of making ex gratia payments in circumstances where that happens, that the Department of Health make payments to participants in a clinical trial where they have suffered some sort of damage which is not the result of any possible allegations of malpractice on the part of those conducting the clinical trial. I should be grateful if the Minister could confirm that that is the position in Britain; also if that would be a possible way of ensuring that there is that full protection.

We want to achieve a number of objectives. We want to ensure that clinical trials can be carried out. That is important for the advancement of our knowledge, for medical reasons. We want to ensure that those conducting them — doctors, dentists, those in the academic medical world — can in fact conduct clinical trials because they can cover themselves to do it. At the moment they have malpractice indemnity. It is absolutely vital that we specify what more we are requiring, whether it is fair to load the medical profession with what I might call the innocent consequences, unforeseen and possibly very harmful consequences for some individuals, but not as the result of any malpractice by the medical profession. Is there another way in which we could ensure that is covered either by the establishment of a fund for that purpose or by a commitment by the Department that ex gratia payments would be made in that instance?

The real question which must be addressed is: are we, in fact, putting a requirement in this section which will make it extremely difficult for those who would normally conduct clinical trials to provide one of the necessary prerequisites to do so, in other words, a policy of insurance and what is meant by that policy of insurance?

I wish to support Senator Robinson on this section. To me it is a question that can present real problems for future progress of clinical trials. From the very start I am aware that the Irish Insurance Association were asked by the Department of Industry and Commerce to comment on the availability of cover. They made it quite clear that probably it was not available in this country. This is the real problem — the availability of the type of cover required by the Minister under this section. I am not disputing it. There should be adequate insurance or funds available in the event of something going wrong in a trial for the person who suffers as a result of that trial. Obviously adequate insurance cover in one case might be totally different in another. In one case it might be a single person; in another case it might be a married man with a family. Therefore adequate insurance cover will vary. It could be £100,000 in one case, £20,000 in another case, and so on. Nonetheless, the principle of having adequate insurance cover is not something with which I would disagree.

The problem is the availability of the cover. Where can you get such insurance cover? I am not talking now about the Elans or the ICPs. I reckon they are large enough to be able to get sufficient cover for themselves. I am talking about university people. A few medical people might come together to conduct a trial in a medical school or places like that. I am not even talking about terminally ill people. Where will such people be able to get such cover? To begin with when will they get a policy or where will they get a fund if it is to be a fund? I believe the whole section has not been sufficiently thought out with its long term consequences for trials. The idea of an ex gratia payment is fine. I would welcome anything that would not hinder the future progress of trials. Despite obvious improvements to the section by the Minister, in my opinion it will still present real problems for many people who want to engage in the business of trials in this country. Hence it might interfere with future trials being conducted.

The Minister has shown, in the way in which he has introduced his own amendments and the way in which he has dealt with this debate from the start, that he does not want to be any more overbearing in this area on either participants, the medical profession or the drug companies than is necessary to protect primarily those who are undergoing tests in one way or another. However, we shall have to go further down the road on this because the position is not sufficiently satisfactory to me as explained by the Minister to date.

I said earlier that the courts in Britain had already indicated that, by and large, doctors are not insured as we know or understand the term "insurance". We are talking here of the British Medical Defence Union and the Medical Protection Society Senator Robb mentioned. The vast majority of doctors in this country are covered by one or other of them. Indeed, I am sure every doctor is covered under these schemes.

We have got to know the implications of whether or not, as Senator Fallon mentioned, we can get insurance cover from the insurance companies established here most of which emanated from elsewhere anyway. Can we get insurance cover? Second, what will the cost of this cover be to doctors, to those involved in setting up these trials? It is very important that we protect the advance of medicine, the advance of research of new drugs. We must ensure that we do not make life so difficult for everybody that we end up in a log-jam of difficulties one after another.

This leads me on to the point Senator Robinson was making. I must say there is a very appealing ring to it as possibly the way in which this matter could be resolved. The State did go into the business — I do not know how long ago, but a long time ago anyway — of setting up a body, which protects the uninsured. I am not sure what the body is called. I do not mean those who do not bother to insure but those who find themselves in a public street, knocked down by a car in a hit-and-run accident. They have nowhere to go, no redress. They do not even know who drove the car and the car cannot be identified.

I think that might be a case for the Motor Insurers' Bureau of Ireland.

I thought it was that but I was not going to say so. Does the Senator know: are insurance companies not involved in subsidising them?

I thought they were. Then it is the insurance companies that provide that. I thought the State was involved in providing money into that fund or scheme. It is there to assist those who are victims of hit-and-run accidents and that sort of thing. In any case, the incidence of insurance being called on in situations of drug trials would seem to be very much more the exception than the rule. The numbers involved in any claim on insurance would strike me as being very small and not a big factor in the enormous health cake the Minister has to cut each year. I wonder whether he could not do what Senator Robinson has suggested and use some part of that allocation to fund those who may require insurance cover of this kind where a major claim arises bearing in mind that the malpractice area is already covered for the medical people taking part in these trials.

This is a critical issue for a number of reasons. We can all accept it, and accepting this premise, we can go on to look at the problem. One should not — nobody should — conduct a clinical trial if one is unable to obtain an adequate insurance policy. One accepts that it is a matter of high risk in one way or another. In effect we are saying very clearly in the Bill, "unless there is in force a policy". We have used the best possible phraseology we could devise in this regard. After considerable talk and consultation we came up with the phrase that a policy of insurance should be sufficient to ensure that adequate funds are available to provide appropriate compensation for each participant who may suffer injury or loss as a result of a trial.

People may question the definition of that. Certainly the ethics committee will have to be satisfied as will the Minister of the day that the insurance policy is adequate to meet the rigours of that statutory requirement. I do not think we can do anything other than that. There may be great difficulty facing individual companies obtaining insurance cover, particularly where there are no commercial sponsors involved. If there are major multinational pharmaceutical companies involved in this area — as indeed very many of them are — they must accept the rights of the individual participant and they must obtain insurance. I would not give way on that obligation on them.

Equally I would not accept under any circumstances — and Senators may allude to this view — that the State should accept the obligation of compensation in the event of a trial going wrong. Even if we were in a position to do it, that would dilute the obligation on the sponsoring companies, on the participating doctors and on the clinical trial personnel because of the prospect of a State take-up in the event of a catastrophe occuring. Therefore, there could not be a blank cheque, or even half a blank cheque on it.

The provision is quite vigorous. So far as I know in Ireland we do not have elaborate insurance provisions available on a ready made basis. Most of the multinational companies who have clinical trials in operation, the sponsoring commercial organisations, endeavour to give themselves some indemnity. Now they will have to prove to us that they are doing that. I do not think it will prevent trials being held or unduly inhibit the prospect of trials taking place. I have no doubt that they will, but they will be taking place under the pretty stringent obligations in the Bill. It will be a matter of judgement one way or the other. The Minister will have to be satisfied that the insurance policy is in force. He will have to be satisfied that it is of sufficient amount by way of cover. I do not see any way out of this. Otherwise the Bill would be diluted in such a way that it would be impossible to go ahead.

The Minister referred to the fact that, as Minister, he will have to be satisfied that the policy is in force, and there is cover, that it must be enforced, that it must be with a reputable insurance company and as to the size of the policy. By that he must mean the limit of indemnity or, in the case of a personal accident policy, the capital benefits. If that is what the Minister means, would he elaborate on his thoughts in that area. If he is talking about the liability side, what is the level of indemnity? If he is talking about a personal accident policy, which I think it would have to be, he is talking effectively about a no fault insurance. The only way you will get no fault insurance in Ireland is from a Lloyds personal accident group policy covering these clinical trial participants. Is he now saying that he will want to know the capital death benefit on a personal accident policy?

I understand fully the point Senator Robinson made about the malpractice as against the no fault risk. There is a down side to this which can be pretty horrific in terms of this open cover which it has been suggested the State should take over. We only have to look at the whole thalidomide situation to see how widespread this can be. I do not believe that drug companies identify the disease they desperately want to cure for altruistic reasons but absolutely and strictly for profit. It does not matter whether the trials are carried out here, or in the Third World. I equate the attitude of most of the drug companies with the attitude of tobacco companies — if it does not run here it will run in the Third World perhaps.

I would be very hesistant in giving what I would consider to be a chancer's charter by way of an open fund. It is also true that there are people in the field of research who are in it as much for personal glory as for anything else. If there were such blanket cover the frontiers of science would be pushed back at the rate of a mile a minute, because they would not have the responsibility. One of the essential brakes on drug testing and development in that whole area is the financial brake. These companies recognise nothing essentially except the financial dimensions of their problems. If the State takes it over they will be quite happy to test anybody and anything for any length of time provided that, in the final analysis, they do not pick up the bill.

Having made those comments, I have no answer to the point Senator Robinson made about where the innocent are hit. In so far as insurance cover is being provided by the testing organisation, there must be a very strong onus on the Minister, acting on behalf of a Government, to ensure that cover is in situ. There can be no stepping aside from that. As the Minister said, for him to have advance notice of the actual insurance cover puts him on hazard. The Government, in the person of the Minister, should be on hazard where the citizen is at risk. He has a responsibility there. I have very grave reservations about giving taxpayer's money as an open cheque to any group of drug testing companies or organisations. It would be a charter for disaster.

I do not want to prolong the discussion unduly on this section, although I agree with the Minister that it is very important because of the public interest aspects of it in relation to whether clinical trials will be able to be carried on in a satisfactory way which will advance our knowledge and have beneficial medical effects. There is a clear difference — and I think most of us have drawn that distinction — between large drug companies who are in a position to get insurance, or should be in a position to get insurance, in relation to any clinical trials they wish to have conducted for their products. I agree with the comments that have been made on that.

Of more concern is the position of the individual doctor, the individual dentist, the person in the academic community, who has been up to now carrying on clinical trials. We are bringing in legislation, rightly, to ensure that there is greater protection for the public. These people do not carry insurance as Senator Robb has confirmed here today. They do not as a matter of course carry insurance. We are not asking them to carry insurance in relation to malpractice. They are already covered for that. They have malpractice indemnity. We are asking them to address the very difficult issue of strict liability insurance for a very hard to predict possible consequence of a clinical trial. I am not an expert on insurance but I feel that in certain cases that could be extremely difficult to get and extremely expensive.

I referred to the practice in Britain where I understand the Ministry of Health assumes a certain role in relation to this no fault consequence that was unforeseen and that causes harm to some or several participants in a clinical trial. They, of course, are the people who must be protected. We are all agreed that they must be in a position where they can be properly compensated and protected by the legislation. I do not quite see why the Minister feels there is no role for the State in this. The State has a very clear interest in promoting clinical trials and in ensuring that, if there is any malpractice, the person engaged in the malpractice bears the burden of that and, therefore, individual doctors and dentists cover themselves for that. That is the normal position and they look to their medical union to cover them.

The Minister may even make an exception and say companies engaged in promotion and sale of drugs can look after themselves even for no fault risk in relation to clinical trials. We are still left with that position. It certainly is something that has a broad public interest concern to it. I do not see why it is so logically necessary that in seeking, as we do, to cover that no fault risk it must be the doctor who will seek to do it, have to cover himself for insurance to do it, and cannot conduct a clinical trial unless that has been achieved. Has the Minister considered, for example, an option of creating within the terms of this Bill a fund in relation to that no fault risk? We will be dealing later with, for example, fees for applications to the National Drugs Advisory Board and presumably there will be a fair turnover of money in applications now to conduct clinical trials. I do not know whether that would be the kind of sum that would be in any way adequate to establish such a fund.

There is a very rough analogy in the travel agency business. There is a fund to cover a case where travel agencies go bust and people suffer consequences. Here we are talking about that no fault but nonetheless quite discernible risk attached to conducting clinical trials. We are trying to consider how to do it. I would like the Minister to indicate that he might between now and Report Stage very seriously consider the concerns that have been expressed by various Senators and possibly distinguish between drug companies under whose auspices a clinical trial is being conducted and individual members of the medical profession, dental profession, or the academic schools who have up to now, on the basis of their malpractice certificates, carried out clinical trials and who are saying — certainly saying to me and other Senators: "We simply cannot get that kind of cover. You will throw out the baby with the bath water. You will stop the whole business". That is very serious.

Having listened to the debate, I am appalled at the situation I find myself in 30 years after graduating. In the one bit of research I did which had danger attached to it, and to which I referred earlier on in this debate, research on children's duodenal ulcers, had any of those children aspirated something from their stomach and been left in the stage of haeomplegia or diminished cerebral activity, provided I could have shown I was not negligent, which I certainly would be endeavouring not to be, then it would have been looked upon as an act of God and the child or the family would not have been eligible to receive any financial compensation.

Therefore, I have now become convinced, as I listened to the Minister and, in particular, to Senator Robinson, that we must cover this eventuality if for no other reason than that the person carrying out the research can live with himself afterwards. You certainly take a great burden on yourself when you are in the course of practice, as I happen to be, penetrating into human beings one way or another. When something goes wrong that is something you carry with yourself. If it goes wrong and you find that the person is crippled as a result, you have to live with that extra burden.

Primarily we are concerned with the person on whom the research is being done but we also have to consider the effect on many other people too. The question then arises, as Senator Robinson has so clearly indicated, as to who will foot the bill for the insurance. I do not think anybody is left in any doubt that the drug company should be left to foot the bill for insurance for research being sponsored by them. There are two other categories of people in the medical world doing research: those who are doing research as employees of a board of health; and those who are doing research as employees of a university. This is something the universities will have to look at very seriously. There may be some way in which the universities could all come together to have a sort of pool of resources to obtain cover for this type of insurance. If we come back to the health boards or the health authorities then, of course, we are back in the lap of the State. I do not think anyone should be doing research on his own which involves danger to the client and this Bill sets out to try to protect the client while at the same time not restricting the opportunity for justifiable research to be done.

At the end of the day, it has been suggested that the insurance premiums that would be required would be fairly vast for no risk type of insurance. I do not feel it is right that that should be left on the shoulders of an individual. This may often be a young man who, rightly or wrongly, may be carrying out this research to meet the needs demanded by a department for his advancement, as has been pointed out by my fellow Senator, as much as to push forward the frontiers of science, although that may be a bonus as a result of this work.

I would like to press the Minister to reconsider his position in relation to this area on Report Stage and to at least give some indication that he will bear very much in mind what a number of us have been saying here today, that is, to distinguish between drug tests being done by the major drug companies or by drug companies generally and the very different circumstances where drugs are being tested in a university or hospital setting. Very often the amount expended on doing those tests is quite limited but the additional cost of being insured to do those tests will probably make it impossible for those tests to continue in the hospital or university where much valuable work is done in this area. The risk for the clinician working with his students in a university or hospital will be an upsetting factor for many people in medical practice. I wonder whether this has been framed with drug companies in mind and whether the Minister could keep the door open to allow for a continuing level of medical research.

The State is not over indulgent in supporting medical research and we do not want to cause unnecessary blockages and difficulties for those who are doing very valuable work. Much of this work — and this is seldom said — has an international reputation. That should be borne in mind. I hope the Minister will not close the door but will come back to us with some formula that will deal with the very different circumstances that arise daily in hospitals and universities. This will have the effect of virtually closing them down. That is the seriousness of this section.

I have been uncharacteristically quiet for the past few hours because I was listening to a very interesting discussion. Clinical trials are still going on and the fact that this Bill is being introduced has not prevented people from holding clinical trials. They are going on with the same frequency and in the same range as they were at the time this Bill obviously became necessary. The provision in this Bill about insurance does not apply to people who are currently conducting clinical trials. It seems to have emerged that, in all of these trials, if something happens to participants which is not attributable to malpractice, they are currently eligible for no compensation at all.

I would like to ask the Minister what the position is in the area of State hospitals where some clinical trials are being carried out. All doctors as a condition of their work have a requirement to have cover. What is the position of doctors in State and health board hospitals who are doing clinical trials if something goes wrong and a participant dies or is seriously injured? Who can that participant sue or are they precluded from suing? My suspicion is that they would not be precluded from suing but that either the individual doctor would be liable to substantial damages which he would be personally liable for and which the medical defence union or the other body would not cover, or alternatively the State, through the health board, would become liable for those damages. If it were the case that either the health board or the individual are to be liable for substantial damages and there is currently no cover available for people under that, until such time as this section or a similar section comes into force, the Minister should request or indeed direct that all clinical trials should cease. There is something highly irresponsible —

An Leas-Chathaoirleach

That is more relevant to the section than the amendments.

I would not dream of arguing with you, a Leas-Chathaoirligh, which probably means I am just about to.

An Leas-Chathaoirleach

I am not too sure who would win.

I have sufficient respect for you and the position you occupy to know who would win. If the position is as the discussion on the amendments has suggested, it is highly irresponsible to be conducting clinical trials anywhere because of the risk that a participant will get no compensation if she or he is injured and the possible risk that the State could be liable for quite substantial damages in the case of a State hospital.

I may be able to put it in a more acceptable perspective by pointing out that at the moment the National Drugs Advisory Board's voluntary scheme which is currently in existence ensures the availability of cover in the event of an accident, sheer stupidity, or totally unforeseen circumstances arising. That is one of the aspects taken into account under the NDAB scheme. The NDAB are very conscious of this and are acutely aware of the prospect of damages being sought against that body and, as such, have had intensive discussion with us. That is an entirely different matter. That is a question of State giving cover to a State body. That would not arise under this framework.

The Bill, in effect, firms up the voluntary arrangement and puts it into a statutory framework. This is a framework in which people will have to exercise, in future, considerably greater caution. It will be more restrictive. Any doctor or dentist who is involved in a trial will perforce have to ask the sponsor to produce his insurance policy. There is a degree of State cover in so far as we have a particular relationship with the NDAB. This is not State cover for people participating in trials but it is a matter of ongoing discussion between ourselves and the NDAB.

Equally we give cover, for example, to consultants under the common contract. We pay the insurance cover for consultants in health boards under the common contract and I often wonder why. My predecessor, a certain parliamentary colleague of mine, was quite capable of signing anything. That was one of the things he signed when he signed the common contract in 1979. We are still paying for it. I have paid much money in the past four years on malpractice. If the public only knew they would have a different view of those kind of developments.

Would the Minister not tell them?

The ordinary common contract cover does not give cover for this situation. Therefore, in future there will have to be greater strictures. I have removed myself from that section to the extent that, in future, the ethics committee will have to be satisfied. After all, the ethics committee will be composed of persons with great professional experience and competence in this area. They will, so to speak, take each trial as it comes. It is quite an exceptional trial. They may exercise great caution and decide to have exceptional cover insurance for that insurance policy. I have no doubt that responsibility, as it is devolved on them, will be effectively discharged.

I must say to doctors and dentists that, if they have been conducting trials without adequate protective insurance for the participants, when this enactment comes into force they will have to change their practice. I could not possibly see the State taking on any further indemnity. I have had difficulty enough with successive Ministers for Finance and will have sufficient difficulty with them over the years. There is no way any Minister for Finance would accept an open-ended indemnity for clinical trials which, in effect, would be perforce brought on him.

It is not very often appreciated that in Ireland we have a flourishing international pharmaceutical community with major R and D working here with tremendous added value. The best part of 20,000 people are employed in the industry. Approximately 10 to 15 per cent are in new Irish innovative industry. I do not think that that industry would oppose an imposition on them which will prove to be so onerous that they will transfer their business, so to speak, to Bangladesh or to those parts of the world where there may be less cover provided. In view of the growing international and public concern in relation to this situation, companies who come here will see the package and if they wish to conduct trials they will know what the outside parameters on their liability are going to be. They will know fully that there is a rigour in force and that therefore there is a degree of stability in the area. To that extent they will accept the provision.

I would like to sharply separate all this from ordinary medical malpractice or ordinary medical accidents. Clinical trials are very different. In any event the result will probably be that the ethics committees will come to the conclusion that the current conventional cover for quite a number of trials will be adequate. As we well know the risk parameters of many substances on trial are fairly well defined before they are subjected to human trial capacity. They will have gone through the battery in many cases of major trials. I could see a situation developing, for example, where billions of dollars are being spent in a desperate attempt to see if we can get a vaccine relating to AIDS. It will probably be at least — I am assured by medical staff — seven to ten years before anything worthwhile is seen in that area despite the amount of money being spent. In that period it may well be that there will be clinical trials conducted on different substances, some of which could have horrific consequences for participants. In those cases one would boggle at the amount of insurance involved. But such is the capacity of people to wish to be involved in trials that; for one reason or another, one would have to seek cover. I can certainly see that kind of situation developing. These are my views on it. I doubt very much that I could accommodate the amendments because if I did the fundamental purpose of this Bill could be in jeopardy and on that basis I would be classified as an enemy of the people.

Jealousy will get you nowhere.

If I have understood the Minister on this point, he takes a pragmatic approach and says that the State, meaning the Department, are definitely not going to be involved because they are already involved in malpractice indemnity cover for consultants and that is bad enough, goodness knows. Surely it is much more appropriate that they should be involved here. Let consultants look after their own malpractice indemnity. Surely the Department have a much clearer role in relation to promoting clinical trials for the benefit of the public good. I am separating the case. I think we are all agreed that pharmaceutical companies generally can cover themselves. If they are the sponsors of clinical trials they can cover all risks involved.

I do not think the Minister has dealt with the position of the hospital consultant or doctor, or the academic, or the person who has been conducting trials in pursuit of desired objectives of testing the effects of a particular drug or appliance and who could not continue to do so, or could not do so, without having insurance cover. I do not think the Minister has answered some of the concerns that have been expressed. He has not referred, for example, to the practice in Britain where the State does assume responsibility in that area.

Finally — and this is the reason I came back on this — I would like the Minister to spell out for those of us who do not automatically know it, what the National Drugs Advisory Board voluntary scheme is in relation to insurance cover in this area. It would be helpful for the debate on Report Stage if we had some idea of this.

We are dealing with the necessity the Minister sees for having doctors, dentists and others covered by insurance when conducting clinical trials. The Minister makes it clear in the section how the treatment of patients is obviously excluded from what we are discussing here. We said a few minutes ago that a drug test is quite distinguishable from the treatment of a patient in a hospital. They are two different situations. There are a considerable number of routine tests going on regularly in hospitals and in universities and I wonder to what extent they will be covered by the necessity for insurance? I can understand the distinction the Minister is trying to make between a new drug being tested on a person who is prepared to make himself or herself available for the purpose of that drug test, and the routine testing of different applications and different uses of not just one drug but a series of drugs which occurs on a regular basis in a hospital or university. I wonder whether insurance is there for what I have just described, or is it there for the big drug tests? Would the Minister clarify when it is necessary for insurance to be taken out? Is it happening in every drug test? It might not be done purely in the interests of the patient's welfare. It might be looking at the use of a drug or a combination of drugs. As I have been advised this is done by people in the field. I do not understand whether the question posed is being addressed and it needs to be addressed.

I want to say one brief thing in response to what the Minister said and I want to support him completely since he did raise it. The common contract for consultants is the most outrageous public service contract I have ever had the misfortune to read. The Minister knows the circumstances under which I had reason to read it and, therefore, I will not go into it because they are personal reasons. It is an outrageous document and, as one who is a signatory to a contract in another area of the public service which is quite a reasonable contract, I consider what went into that contract is a disgrace, and it is a disgrace to whoever was responsible for introducing it. The small matter of the medical defence fees is only a small part of a quite outrageous contract. I agree with the Minister that it should never have been allowed in the first place. That is 100 votes among my constituents gone.

I will take the point raised by Senator FitzGerald first. There is no doubt that where the hospital consultant decides on a clinical basis to have a routine series of tests which may border on a trial basis, he has cover under his ordinary insurance and under the common contract. Equally quite a number of hospital boards are now beginning to carry separate insurance to cover actions being taken against the board as distinct from the consultant. The consultant may be a junior hospital doctor and he may be in Iraq at the time the action is taken in Ireland. He may have emigrated and be gone from the jurisdiction. I am not suggesting that happens often, but I have know cases where it has happened. On that basis the ordinary hospital cover and the ordinary medical defence union cover are paid by the State in both instances and in practice would give cover for the doctor concerned. That clarification is fair and reasonable.

As regards the voluntary cover scheme, it has been the practice that the NDAB have to be satisfied. Senator Robinson raised that point. But there are no internal criteria laid down by the department with the NDAB as to the precise parameters of that insurance cover. Therefore, I am not in a position to elaborate on it. The insurance phrasing used in the Bill is wide enough to cover a whole range of trials from new preparations to well-known ones. The ethics committee — who are the key to this issue — must be satisfied. They will have considerable independence to make up their own mind as to the sufficiency of the policy and the adequacy of the funds which could be available. On that basis the Bill is reasonable. It gives cover and, above all else, the whole thrust of this Bill is to give cover to the participant.

There are many other people involved — the Minister, the ethics committee, the doctor, the insurance company, but the thrust of the Bill has been to place the rights and well-being of the participant to the forefront. Again in that section we come to the fundamental purpose of the Bill. I would have great difficulty in construing it in any other way or endeavouring to be more even-handed in any other way. I do not think it will impose on the medical profession who are very experienced particularly at senior consultant level. The consultants are very experienced on the question of new drugs, the question of experimentation and the question of trials and I would be very surprised to find any undue imposition on those consultants directly involved.

The Minister is prepared to come back on Report Stage on amendment No. 45 and to that extent it is withdrawn. Is not that the position?

Amendment, by leave, withdrawn.
Amendment No. 46 not moved.
Government amendment No. 47:
In page 8, subsection (1), lines 14 and 15, to delete ", issued by an authorised insurer,".
Amendment agreed to.
Government amendment No. 48:
In page 8, subsection (1), lines 17 and 18, to delete ", and a copy of the policy of insurance has been supplied to the Minister".
Amendment agreed to.

I move amendment No. 49:

In page 8, between lines 18 and 19, to insert a new subsection as follows:

"(2) In the granting of compensation referred to in subsection (1), due consideration shall be given to any contributory negligence on the part of the participant".

I am repeating what other speakers have been saying. During the conduct of a trial, if it is clearly proven that there is an element of misrepresentation, or whatever, on the part of the participant to the trial, despite all the best efforts of the screening and the monitoring process at the start and right through until people are satisfied that the drug has left the system, the ordinary common law, the ordinary legal process of contributory negligence, should apply and this factor should come into play in the settlement of any subsequent claim that might arise. The Minister has referred to a no fault situation but would he agree to this one amendment to ensure that, if blame attaches to the other side, that is appropriately considered in any claim settlement.

I want to express the fears I expressed on Second Stage and to support this amendment. Senator Fallon is seeking more accurately to draw out from the Minister exactly what the position will be concerning the method by which people who have suffered some injury or loss as a result of a trial can get compensation. If I take Senator Fallon's point what he means is as follows. You could imagine a situation where a person would mislead those who were conducting the clinical trial, would have himself included in the test panel, if you like, for the clinical trial, and as a result of the non-disclosure of certain vital information would be damaged by the clinical trial itself and then would seek compensation.

That is very close to what I said on Second Stage. I thought what we were seeking in terms of a policy of insurance was a no fault insurance and I wonder whether that is indeed possible. The Minister speculated earlier in this debate on the enormous premiums that would be looked for in the case where somebody was, for example, conducting clinical trials into the question of AIDS, because injury or loss as a result of the trial would be very likely at least in the initial stage of such a dramatic clinical situation. I wonder whether the Minister could cast more light on this whole question.

What is the Minister's understanding of this amendment in so far as it relates to the word "appropriate" in section 9, where it talks not just about the necessity to provide compensation but "to provide appropriate compensation". Does that mean it will only be necessary to provide insurance for compensation which is as a result of the negligence of the person conducting the trial and is that the meaning of the word "appropriate"? Would the word "appropriate" as it is now cover the situation envisaged by Senator Fallon?

In other words, would it be open to those who are defending an action for a claim by a person who misled those conducting the trial and got himself included as a result of so misleading to say that person is not entitled to any appropriate compensation, or the appropriate compensation for that person is nil because of the way in which he has conducted himself? This whole question is the type of liability that will attach to those conducting the trials. That has to be more fully spelled out within the legislation and, in so far as Senator Fallon's amendment seeks to do that, I support it.

Senator Fallon's amendment, well intentioned as it is, is unnecessary. It is a very well established principle, as we know, that in assessing compensation due regard is given to contributory negligence on the part of the plaintiff and, on that basis, the inevitable inclusion of that principle arises. That is the first point I make in relation to the amendment. It may be that it is a matter for decision by the courts and it would not be appropriate to include the provision in the legislation as such.

As regards the second point raised by Senator O'Leary quite understandably, the recommendation I have had from the Attorney General's office and from the parliamentary draftsman has been that the phrase "appropriate compensation" is the correct phrase to include in this section.

We have looked at it. We have considered whether it was too vague or too generalised, but we have been assured, and I broadly accept the argument, that there are so many exigencies relating to a particular compensation claim, as we well know, which have to be taken into account, that it would be quite impossible to elaborate any further in the section. There would inevitably arise the whole gamut of the circumstances of the individual concerned who participated in the trial in an endeavour by the court to arrive at appropriate compensation. But the court would have to define that, not the Minister, nor for that matter the person seeking compensation. The ethics committee would have to be satisfied that, such were the risks inherent in this particular development, this new trial, that they could give an assurance to themselves and, indeed, to any inquirer that there were adequate compensation provisions in existence in the event of anything going quite wrong. That is, in effect, the basis of the section and I doubt very much that we could improve upon it any further this afternoon.

What I am seeking to get from the Minister is extremely relevant to the amendment which Senator Fallon has put down. Is the Minister saying in regard to these trials that the normal rule of law will apply, that a person will only be responsible in law where they have been negligent, if they have not been negligent they will not be responsible? Is that what the Minister understands and is that what his advisers understand the words `appropriate compensation' to mean? In other words, is there going to be as a result of this a strict liability or are the normal rules of law going to apply?

As far as I can envisage and as far as I have been assured, and the whole thrust of my argument in relation to this Bill is that the normal laws of compensation would arise in terms of assessment. If, for example, an applicant supplied wrong information either as a participant or to another person, that would be reckoned as part of the argument within the trial proceedings. Inevitably that would come up and in section 11 we have incorrect and misleading information covered where:

(1) No person shall provide or cause to be provided to another person any information, evidence, documents, samples or other materials — .... which are incorrect or misleading.

That encompasses that aspect of it.

When you talk in terms of sections 11 and 12 you are talking of offences where you are being prosecuted. There is an absolute difference between offences and being prosecuted. It appears that in section 12 the Minister is making a halfway house between a strict liability offence and an ordinary defence. You do not have to prove mens rea but you are given a reasonable defence under subsection (2). That is rather different from an appropriate compensation which is the civil action basically where the person who was injured by the clinical trial would be taking an action for negligence. What Senator O'Leary is asking is if it would be like an ordinary action for negligence which would allow for contributory negligence in the normal way and is that what “appropriate compensation” means, or has it any other meaning?

I am a little bit confused now because I understood the precise reason why section 9 was inserted in this Bill was to make provision for a situation where negligence did not exist because of the possibility of a risk existing which could not be foreseen in which case, therefore, no negligence on the part of the person conducting the trial could exist and none could be alleged, but that there was the reality of the possibility of people suffering serious damage and possibly death because of an unforeseen consequence of a trial. That is, after all, why we have trials. If there were not the possibility of unforeseen circumstances and unforseen injuries, we would not need trials. It is because these things can happen that we need trials.

I understood that the function of section 9 was to provide that people had to have insurance not just to cover injuries resulting from negligence on the part of the people conducting clinical trial but injuries resulting from entirely unforeseeable happenings. If that is the case I do not understand how the ordinary rules that apply to assessing compensation where negligence is involved can apply in a situation where negligence does not arise in the first case. Not for the first time I find what Senator O'Leary has to say interesting and worthy of further elaboration.

I think circumstances can arise where a particular company in asking a prospective participant to complete a questionnaire does not disclose to the individual concerned the full details of the dangers inherent in the trial. That would be a very grave matter of omission and would feature in very large measure in a civil action for compensation within the ordinary compensation claims. Equally in reverse, where a participant completed a questionnaire and quite deliberately left out of the questionnaire — for the sake of argument — that he had failed to record the fact that he had been on a trial for another drug perhaps five or six days before with a different company, that would feature. This section is so framed that it is rather open, and deliberately kept somewhat open, because if we imposed rigid definitions in this section we could frustrate the prospect of compensation. If, on the other hand, we left it totally open-ended, everybody who participated in the trial could claim that he saw a young nurse and he suffered whip lash in his neck and this was the inherent part of his trial and he required "appropriate compensation". One has to be very careful in that regard.

The Minister is not enlightening us any more than we were enlightened previously. I suspect the reality is that nobody in the Minister's Department knows the answer to the question and if that is the case the Minister should go away and think about it again. Unfortunately it is necessary to go slightly beyond the amendment itself but because of the contributory negligence aspect it is likely to go along. What we are proposing to amend deals with "appropriate compensation" for each participant who may suffer a loss or injury as a result of a trial.

Rather than explain my problem to the Minister I should explain to him that there are two stages in assessing compensation for any individual who alleges he suffered loss or damage. One of the things to be established is whether the person was liable. If the person was liable, what was the monetary value of the injury suffered? It is possible for a person to be liable for an action but for the court to decide there was no real injury — you are not entitled to compensation as a result of the liability but only as a result of the injury. Similarly, it is possible and, indeed, very likely that you could have an injury without any liability.

I have a bad injury to my back but it did not arise from any wrong that anyone did to me. In other words, there are two elements of the case which are necessary. If you superimpose those general principles on section 9, either in its original form or as it is proposed to be amended by Senator Fallon, you say that under section 9 there should be "appropriate compensation for each participant who may suffer injury or loss..." In other words, every participant who suffers injury or loss appears to be eligible.

The use of the word "each" seems to suggest that it is open to everybody and that there is strict liability. That is somewhat changed and restricted by the use of the words "appropriate compensation". What is the meaning of the words "appropriate compensation"? In other words, would it be open to a defendant in an action to say: "Yes, he or she, the plaintiff, did suffer loss or injury which is worth £50,000." The appropriate compensation in this case is nil because there was no negligence on the defendant's part.

Do the words "appropriate compensation" reintroduce or reinforce the concept of liability being at issue in these things? It is my belief it should be there. At present I am not really concerned with whether it should be there or whether it should not be there; I am just trying to find out if it is there so that I will know whether to agree with the Minister. There is no point in the Minister saying there are cases where people give wrong information and that in his view a deduction for contributory negligence in those cases is possible.

The question I have is actually much simpler than that. Is there strict liability in respect of any injury done to a participant? Is that the intention of the section? If it is not, what is the Minister's advice as to the effect of the words "appropriate compensation"? Is the use of the words "appropriate compensation" in the view of the Minister sufficient to reintroduce into the concept the full normal common law negligence arrangements? Is that the meaning of `appropriate compensation'? There are two questions. Does the Minister think there is strict liability? If there is not strict liability, does the Minister think that the words `appropriate compensation' are sufficient to apply the normal rules of negligence?

Before the Minister answers perhaps I might put a supplementary question to what Senator O'Leary is saying. Senator O'Leary spoke about strict liability and Senator Ryan said that regardless of whether there was negligence where a person is injured in a clinical trial they should receive compensation. That is probably the intention because obviously it is one of the risks of these trials that there may be damage to a person even though there is no negligence. In that case, does "appropriate compensation" mean that one does, as is suggested in Senator Fallon's amendment, take in the fact that the person may, for instance, have omitted to say that he was a diabetic or something of that sort which would have an enormous effect on the way the drug affected him.

On the other hand, if one says that "appropriate compensation" just brings you back into the ordinary negligence field, then the section is saying that people who conduct clinical trials must carry insurance against negligence. A person such as a solicitor, barrister and so on may feel that he must carry insurance against negligence but he is not necessarily statutorily forced to do so. Motorists are forced by statute to carry insurance against negligence. Is this merely saying that one has to have insurance in case there is a negligence action taken against one? Or is it saying that wherever an injury arises from a clinical trial, regardless of whether there was negligence, compensation will be paid to the person but the word "appropriate" may mean the only compensation that will be paid will take into account the fact that the person has done something stupid?

We found it difficult to strike a balance in framing this section and I would not deny that in any way. It is not an absolute "no fault" provision. If that were there, as Senators are aware, a participant who deliberately misled the conductors of the trial would receive compensation. If, on the other hand, the criteria laid down before a person undergoes a trial have been neglectfully conducted by the participants of the trials, such as, for example, the medical examination that persons undergo before participating in the trial which is stated quite clearly here, if they fail to monitor the health of the participant during and after the trial and if they fail to provide an independent medical examination for the participants, if all or any one of these provisions are neglected, the court's assessment of the degree of negligence would arise.

We are in a unique situation here in terms of our own drafting of a provision of this nature. As the title of the Bill states, we are dealing with a situation where compensation can arise in relation to the administration which may have a harmful effect. It is rather an unusual effort to bring under law a prospect of compensation on that basis. We have kept it as flexible as possible but the records of the ethics committee and all of the data would have to go before a court and reach a unanimous judgment as to whether there was an inherent danger to which the individual has subjected himself and whether there was adequate compensation provision if it went wrong. I would like to find out what provisions the BBC had in relation to the individual who offered to undergo a particularly dangerous trial. It would be interesting to see how they covered that matter.

The two stages outlined by Senator O'Leary are encompassed in the section itself. It is not unlimited and, at the same time, we have to have sufficient monetary prospects for the individual who is injured as a result of the trial. It will be very difficult. If a trial goes wrong in that framework it can badly go wrong. God help the individual who is claiming because it is he who in many respects must prove it and will be the subject of the claim. I am in the hands of the House but I do not see how the House can devise a framework which would be more appropriate for a compensation prospect.

The Minister may be confusing two things: in fact, we may be confusing them ourselves. Perhaps if I could give a hypothetical example to explain exactly what I mean. Let us take the case of a drug company testing a drug for the treatment of duodenal ulcers. The person to whom the drug is given, and who is ultimately injured, appears healthy. He passes all the normal tests, has no blood pressure and so on. However, he does not know and the tester does not know nor is the tester expected to know, that the person is suffering from something which is not obvious, such as glaucoma, an illness which is not easily detected in a normal medical examination — a person can have perfect eyesight and suffer from glaucoma. If he takes this drug one of the side effects could be disastrous for his eyesight but if it goes through the courts in the normal way there would be no negligence against the medical practitioner because he could not reasonably have been expected to know that the person had glaucoma or that glaucoma was one of the conditions to which there would be an adverse comment. The person therefore is stopped from being adequately compensated in the courts. The Minister says we will have a policy of insurance in operation. That policy is not a substitution for the right of the person to go to court but an additional safeguard. Is it the Minister's intention that the policy of insurance should cover that? Here is a situation where there is absolutely no negligence. Is it the Minister's intention that the policy of insurance should cover a person who is injured where there is no negligence on his own part and no negligence on the part of the person who conducted the trial, but it is just a side effect which happens and nobody knows about it until it does happen. Does the Minister envisage that that kind of situation would be covered by that policy of insurance?

I think the answer is in the affirmative. The individual concerned can be entirely blameless. The company concerned can be entirely blameless. It can arise in the case of the example I have given. We still want to have a situation where compensation is provided in the inherent thrust of the Bill because there are risks involved.

I am happy with that.

The risk as stated here in the title of the Bill is:

...control over the administration of one or more substances or preparations to persons for the purpose of ascertaining the effects of the administration of such substances or preparations on those persons where such administration may have a medical or harmful effect. ...

That is a contingency compensation provision effectively. Unquestionably in the years ahead there will be companies who will dispute the amount of compensation and they may infer that there was massive neglect. On the other hand, the applicant may infer that he was misled in the inducement offered to him to undergo the trial and that had he known the prospective harmful effects, which could have been brought about, or had he been forewarned of them, he would not have undergone the trial. That is my interpretation of it. The example given has helped us to clarify this issue.

I am happy with that. Effectively what the Minister is saying is that, in a position where there is no fault on either side, compensation will be provided but where there is fault on the part of the person participating that will be taken into account as well.

While it is not looked for there may be fault on both sides.

I understand that. I am very happy to have the situation brought about that, where there is no fault on the side of the person participating, he or she should be compensated. I am in 100 per cent agreement with that. What I do not agree with, in this or in any other case, is that where there is positive fault on that person's part that he should be compensated automatically. They may be compensated for other reasons, perhaps because of an overwhelming fault on the other side. If one takes the simple situation where there is absolutely no fault on the person who is administering the drug and 100 per cent fault on the person who is taking it, I do not think that person should be compensated. I am very happy that a person should be compensated where there is fault on the part of the person who is giving the drug or, alternatively, where there is no fault on either side.

Amendment, by leave, withdrawn.
Government Amendment No. 50:
"(3) In this section `arrange for the conducting of a clinical trial' does not include any measures taken for the purpose of arranging a policy of insurance to which this section would relate.".
Amendment agreed to.
Section 9, as amended, agreed to.
Section 10 agreed to.
Question proposed: "That section 11 stand part of the Bill."

We have, for instance, legislation about animal trials where there are inspectors who are authorised to visit premises where such trials are conducted to ensure that the regulations and the laws drawn up to protect animals are being enforced. It appears that there is no provision in this Bill dealing with clinical trials on human beings for any equivalent inspectorate who could do a similar job in the case of clinical trials. It seems rather peculiar that we have an inspectorate dealing with trials on animals and yet we have not necessarily similar but comparable trials being conducted on people and no system of routine or on-the-spot inspections to ensure that all that has been said here about how things are to be done, how people are to be looked after and so on, is actually being done on a day to day basis. Is there a particular reason the Minister has not made some provision for inspectors, whether officers of his Department or officers of the health boards, to visit clinics on a day to day basis and have the right to see records and the right to talk to people without any forewarning in order to ensure that what we all want to have done is actually done?

I thought the House had agreed to section 10—

It arises on section 11 — the provision dealing with misleading information. It arises also on section 13 "onus of proof of medical or harmful effect". It has arisen on a few occasions.

I think I can assure the Senator that in the guidelines we prepare and in the administration of the Act we would certainly include a provision that the persons conducting the trial, the companies concerned, would have to agree before permission would be given that, at any time an officer of the Department or a delegated officer would have full access. We might, for example, ask a director of community care in a health board area or somebody with clinical experience to act on our behalf. The company would have to agree as a precondition that full access would be given. This can readily be encompassed in the seeking of information not just simply exchanging correspondence.

I am helped by what the Minister has said. I can well believe that it would be part of the conditions of a clinical trial that it should be open to the Minister to send somebody in, in this kind of way. All things being well, that would happen. At the same time it might possibly be better if some sort of statutory provision was included that would specifically state that, as well as people complying with requests for information, that any officer of the Minister's Department should be able to gain access to the place where the trial is being held and to the books of the trial.

I take the point made by the Senator. I will certainly have a look at that section before Report Stage and possibly come back on it, if it is lacking in any way in that framework.

Question put and agreed to.

Amendment No. 51 is consequential on Amendment No. 52 and are to be discussed together.

I have taken some advice on these amendments and I do not wish to move them.

Amendments Nos. 51 and 52 not moved.
Section 12 agreed to.
Government amendment No. 53:
In page 9, line 41, to delete "medical" and substitute "pharmacological".
Amendment agreed to.
Section 13, as amended, agreed to.
Section 14 agreed to.
Government amendment No. 54:
In page 10, subsection (1) (a), line 1, to insert "notifications or" before "applications".
Amendment agreed to.
Government amendment No. 55:
In page 10, subsection (1) (b), line 4, to insert "a notification or" before "an application".
Amendment agreed to.
Section 15, as amended, agreed to.
Sections 16 and 17 agreed to.
Government amendment No. 56:
In page 10, line 29, to insert "(1)" before "This Act".

I have two amendments. The purpose of this amendment is to give time for the necessary administrative arrangements to be made. The powers in sections 16, 17 and 18 may need to be availed of for the purpose of the administative arrangements preliminary to the commencement of the scheme. Also it is necessary to provide for the submission of applications in advance of the date of commencement of the Act to avoid a logjam of applications at the time of commencement. I can assure Senators that there will be no delay in the enactment and in commencement dates under the scheme but it does provide a reasonable flexibility.

Amendment agreed to.
Government amendment No. 57:
In page 10, after line 30, to add the following subsection:
"(2) This Act, other than section 16* to 18* and this section and so much of sections 1 to 17* as is necessary to give effect to section 2 (3)*, shall come into operation on such day as the Minister shall by order appoint.".
Amendment agreed to.
Section 18, as amended, agreed to.
Government amendment No. 58:
In page 3, line 8, to insert "(including kinetic effects)" after "effects".

My father brought me up to believe that if you do not understand something you should always ask. I know what the word "kinetic" means. I do not know what the word "kinetic" means in this Bill. I would be interested to know. I do not like approving things I do not understand.

Pharmacokinetics and bioavilability are indentified here, as are the therapeutic effects, the comparative effects. These are effectively the four questions encompassed within this amendment. The term "pharmacological" that has emerged as a more appropriate word than "medical" which is dealt with in the other amendment. We have been advised by the profession that "including kinetic effects" should be included in the definition of the conduct of a clinical trial. This has been a matter of professional consultation.

According to the Schedule I have, the Report Stage of this Bill is scheduled for Wednesday 10. Could the Minister tell us when he will have the amendments circulated?

We can have them immediately. We have been working on the amendments and we already have some of them. The revised Committee Stage Bill will be circulated in the next day or so. I am in the hands of the House, I would wish to have the Bill put through all stages as a matter of absolute expendition. I would wish to order the Bill for next week.

It is the intention to take Report Stage next week.

Would the Minister comment on the level of fees he has in mind, how it is proposed to collect these fees and who decides on the fees?

In general — and we have had this now in relation to a large number of matters — the insistence has been to bring about a degree of self-financing in relation to legislation of this nature. This has been a long standing Department of Finance provision in recent years and we will most likely have to work within that framework. I do not know the precise levels. I do not think they will be that onerous because already the National Drugs Advisory Board are incurring substantial expenditure. There is a State subvention of well over £½ million a year.

Who decides for example on a particular trial which may take a week to conduct? Who will be saying: "we want £100 for that trial and a trial of less importance will that be £50"? Who will finally decide?

I think in consultation with the NDAB we will work out a sliding scale of fees but the overriding principle is that this work of public control must be self-financing as I indicated. I will write to the Senator about the matter.

There will be consultation with the National Drugs Advisory Board regarding the fees. That is fine.

Amendment agreed to.
Government amendment No. 59:
In page 3, line 11, to delete "medical" and substitute "pharmacological".
Amendment agreed to.
Title, as amended, agreed to.

I have to report especially to the Seanad that the Committee has amended the title to read as follows:

BILL entitled an Act to provide for control over the administration of one or more substances or preparations to persons for the purpose of ascertaining the effects (including kinetic effects) of the administration of such substances or preparations on those persons where such administration may have a pharmacological or harmful effect, to provide for ethics committees in relation to the foregoing and to provide for other matters connected with the matters aforesaid.

Bill reported with amendments.
Report Stage order for Wednesday, 10 December 1986.