Amendments Nos. 1 and 4 are related and may be discussed together. Senator Ryan to move amendment No. 1.
Control of Clinical Trials and Drugs Bill, 1990: Committee and Final Stages.
Section 1 agreed to.
SECTION 2.
I move amendment No. 1:
In page 2, line 18, to delete "purpose" and substitute "objective".
I do not want to delay either the House or the Minister unnecessarily, but in pursuit of a long standing campaign of mine for intelligible legislation — among the more difficult of the campaigns a man could undertake as a Member of either House of the Oireachtas — I do expect a reason for changing words. Section 9 of the Act, referring to the conduct of a clinical trial on any person suffering from an illness, says:
Where it is proposed to conduct a clinical trial on any person suffering from an illness the remedy for or alleviation of which constitutes an objective of the trial
The Bill says that section 6 (2) of the Act is to be amended by the substitution of "the principal purpose of that administration is to prevent disease". I am not playing silly semantic games but, as I said on Second Stage, and as it was not replied to by the Minister I have to raise it again, I cannot find a dictionary distinction between "purpose" and "objective". It makes legislation more complicated and it creates potential areas of argument for lawyers — and they can find them where the rest of us would not dream any existed — if there is an alleged difference between "objective" and "purpose". There are definitions of "purpose" and definitions of "objective" which are different, but there are also definitions which are so similar as to be identical. If the Minister can explain what the difference between the "objective" of a trial and the "purpose" of a trial is, I will happily withdraw the amendment but if there is not a reason for putting in a different word, then let us leave the same word in the amendment that is in the original Act.
I take the point the Senator is making about the use of the different words "purpose" and "objective" which can have the same meaning. However, in the original Act the word "objective" is used, for example, in section 9 of the Bill, page 10, line 5, and the Senator has referred to it, but in section 9 (7) it states:
provided that a clinical trial to which this subsection relates may be conducted only if the substance or preparation under trial is to be administered for the purpose of saving the life of such a person, restoring his health, alleviating his condition or relieving his suffering.
I presume it is in keeping with that particular section that the parliamentary draftsman used the word "purpose" in the section referred to by the Senator, section 2 (2) (a) (ii), so it is used in both section 9 and section 2 in the original Act.
Even though I am not going to pursue it, the point is made. If the parliamentary draftsman uses the two words interchangeably in the one section of a Bill, maybe somebody should talk to this mythological person, the parliamentary draftsman, about simplifying his or her English because they do not make life easy for people trying to deal with the Committee Stage of legislation.
Amendment, by leave, withdrawn.
Acting Chairman
Amendments Nos. 2, 3, 5 and 6 are consequential and may be discussed together.
I move amendment No. 2:
In page 2, line 20, to delete "patient," and substitute "patient, and"
Amendment No. 2 simply adds a word to enable amendment No. 3 to be introduced. I am concerned — this is a serious issue — because from the time when the Act was introduced as a Bill in 1986 I had a considerable involvement. Committee Stage in this House was long, detailed and, let it be said, unreported in which a considerable amount of constructive work was done.
It is extremely important that the distinction should be clearly in our legislation between using drugs to alleviate suffering and trying out drugs for any sort of commercial purpose, not suggesting even simply for the doctor's commercial purposes, but for the commercial purposes of some company who, in turn, provide incentives to the doctors to try out their drugs. It appears to me that as it stands, having read the Act and re-read it to remind myself, and looking at the amendment it would be perfectly reasonable for a doctor to be offered incentives by a company. I am not talking about unethical behaviour. If a doctor uses a drug that he or she knows to be unsafe on a person who is sick, then that doctor is guilty of unethical behaviour and will be dealt with by the ethical procedures of the Medical Council, and indeed will probably end up in court as well. I am talking about the fact that as well as being ethical, these practices must be seen to be ethical. They must be seen to be above suspicion.
Having a brother a doctor and being married to a doctor, I have no choice but to have a high opinion of the medical profession but I am still unhappy about multinationals and their consistent campaign — the drug "do's", the sponsored meetings, the sponsored travel, the golf outings, the apparently limitless amount of sponsorship funds that are available to various activities connected with medicine from drug companies. In the famous phrase about advertising, half of that money may well be poorly spent but nobody knows which half. Similarly about the involvement of drug companies in persuading, by various methods, doctors to use various drugs, they must believe it is worthwhile because they are hard-headed business organisations which are dedicated to making money. I am not here wearing any sort of hat about the profit motive or anything like that but that is their objective. They are there to make money to reward their shareholders. I discussed earlier what the shareholders could perhaps do to share the risk.
Let us remember in spite of what was said by the Minister, Deputy Smith, in his reply on Second Stage, there is nothing in the legislation which suggests that the amendment will only be used in limited cases. What the amendment says is that conducting a clinical trial means something but does not include what is defined as a clinical trial under a number of circumstances, one of which is the additional one, which states that "where the principal purpose of that administration is to prevent disease in...". There is nothing in the amendment that says it must be done quickly or that there is any urgency about it. It simply says that where: "the principle purpose of the administration is to prevent disease in or to save the life, restore the health, alleviate the condition or alleviate the suffering of, the patient,". These are all most admirable objectives to which we all subscribe, but there is no word in it about urgency.
I am quite prepared to listen very carefully on this but it seems to me that we are saying that wherever drugs are to be tested on people and where the principal objective is to do all those admirable things, then they are excluded under the provisions of the Clinical Trials Act, because they are not clinical trials. It does not say anything about where urgency dictates, where the suffering of human beings suggests that we should take a shorter route or any of those things. It does not say anything like that. It simply says where certain objectives are to be met. It appears to me that as it stands, that means that any administration of substance — and I am not arguing about unethical behaviour — where it can legitimately be said that the principal purpose is to help a sick person, then all the provisions of the Clinical Trials Act are excluded. That means we could be involved in commercial clinical trials involving sick people where the doctor could well be paid for doing those things. I do not think that is very healthy, I do not think it is a good idea. I think we should specifically write into our legislation that the doctor should not be paid.
My amendment states: "provided that no rewards whether in cash or otherwise are offered to the registered medical practitioner, or the registered dentist for the administration of the substance or substances...". That is the first part of my amendment. Since we are again clearly not talking about clinical trials, we are talking about sick people and something that could make them better, it seems to me perfectly reasonable to exclude all the nuances of clinical trials and therefore, the second part of the amendment states: "and provided that no material incentive is offered to the persons to whom the substance or substances are to be administered.". In other words, if the people are sick there should be a sufficient incentive in the possibility of alleviation of their suffering or getting better without any cash being offered.
Since we have not written in any condition of urgency, any condition of haste, but simply a blanket exclusion of a certain kind of administration of substances, the least we can do is to ensure that nobody can be in it for money or can be seen to be in it for money. That is why I moved the amendment.
I would like to support Senator Ryan with regard to amendment No. 3 because I think the introduction of a cash reward element is a dangerous and inappropriate practice. The reason I am so happy to support Senator Ryan in this is because I took the trouble to read the debates on the main Bill when it was introduced in 1986-87 and I was extremely impressed by the care that was taken at that time to allow the fullest possible discussion. I was struck particularly by the fact that by agreement of the House, my former colleague, John Robb, who is a distinguished medical expert, was allowed extra time to place on the record of the House his particular view on the Bill.
In the limited time available to him — he had to go to a meeting and so on but they very kindly extended the debate over the period of a sos and he spoke for about 20 minutes — he spent a very considerable part of that time in addressing precisely this issue. He did it, as he sometimes did, with a certain flair for the theatre and for gesture and he waved in the House a cheque for £10 sterling which, he said, was uncashed but which he had received from an international drug company — accompanied by a phial of drugs and ten report cards to be filled up by the doctor with regard to the patients' medical history profiles, the date on which the drug was administered, the result and so on. He was told that the £10 was a registration fee and that he would receive further remuneration subsequently if he continued to administer this drug.
It seems to me that makes the amendment a very practical and relevant one because it is not just a theoretical matter, it is one where a distinguished medical practitioner has had direct personal experience of an attempt by a drug company to introduce the motive of personal financial gain, reward, profit, whatever you like to call it, into the medical treatment of that doctor's patients. I really think we would be foolish not to bear in mind the wisdom of a previous debate in this matter. It was a point that was extremely well made by Dr. Robb.
I realise the Minister is anxious to get his Bill through this evening and I am quite happy to facilitate him. I do not feel that there should be any immense difficulty because I do not see anything in this amendment that contradicts the spirt of the legislation. Perhaps the Minister would consider in the light, not just of the evidence introduced in the argument, the theoretical position advanced by Senator Ryan, in addition, of course to his family connections with medicine, but also in the light of the very detailed debate and the hard solid evidence that was introduced in this House by one of the Taoiseach's nominees, a man whom we all respect and who has a very high standing in the medical profession.
On the face of it, I have a certain sympathy with the motives behind this amendment, and particularly the motives as suggested by Senator Norris and indeed quoting a previous very distinguished Member of this Chamber. However, the fact that one might sympathise with the motives does not necessarily mean that one would agree with the amendments themselves. In practice, the situation is that in respect of an actual reward, whether it be cash or otherwise, offered to a registered medical practitioner or registered dentist, I would doubt if it is a significant factor. I doubt if it is a factor at all in any cases, with any clinical trials that are conducted in this country or in any other country where one has, as Senator Ryan has rightly said, a reputable medical profession. The sum of money mentioned by Senator Ross, quoting the former Senator Robb, would be, to many practitioners, I would think, a matter of irritation rather than anything else. It would not represent an adequate fee. The intention is perhaps to make some contribution towards the inevitably considerable extra time and trouble involved in participation in a clinical trial. Such trials can be very demanding in time, and rightly so.
I would also be slightly concerned about this amendment from two other points of view. With great respect to Senator Ross he is constantly bringing in this totally irrelevant reference to multinational drug companies. The amendment, of course, would apply in all circumstances and not just to multinational drug companies. The multinational drug companies are a very easy target. I do not doubt that from time to time they do make errors, and probably grave errors but at least with the multinational drug companies we have had many new advances in medicine whereas I cannot think of one pharmaceutical preparation that has come from the sort of State sponsored organisations or countries that Senator Ryan at times seems to suggest we should follow.
There are certain circumstances where it could be argued legally that any remuneration or reward paid to somebody, such as a research registrar, involved in clinical trials related to the fact that he is involved in the administration of some substance which is being tested. It would be an unfortunate amendment. I sympathise with Senator Ross's intentions in relation to this amendment, and indeed some of Senator Ryan's intentions but I do not really think it would be helpful or that it would serve in practice any useful purpose; it could even be detrimental.
I also sympathise with the motives Senator Ryan outlined in proposing his amendment. Certainly none of us would want to see the type of commercial approach he described. He did suggest that perhaps by accepting the section as it now stands it was opening the way for all trials because urgency is not included in that particular subsection. If we look at the definition of a "clinical trial" in the Bill, which is very specific, it says:
the conducting of a systematic investigation or series of investigations for the purpose of ascertaining the effects (including the kinetic effects) of the administration of one or more substances or preparations on persons where such administration may have a pharmacological or harmful effect, but does not include the conducting of such a systematic investigation or series of investigations as aforesaid.
That would mean that what Senator Ryan wants in the amendment certainly could not be considered a clinical trial; so it would preclude any practitioner from using this particular section of the Bill in order to avoid having to go through the necessary procedure. As the Bill stands it is quite clear what is intended. When taken in conjunction with the definition of a clinical trial in the Bill there can be no doubt that this section could not be used for the purpose of avoiding having to work within the legislation to carry out a clinical trial.
As worded, the amendment could be open to the interpretation that any practitioner who was in receipt of a salary, for example, might well be found to be in breach of this section of the Act. That, of course, would defeat the very purpose of having this section in the Act to allow, in bona fide cases where there is the question of a life saving drug, a practitioner to be exempt from the control of the clinical trials legislation. It could defeat the very purpose of that section of the Act if we were to accept the amendment as worded.
Acting Chairman
Is the amendment withdrawn?
We will see in the fullness of time. The Minister has at his disposal this formidable entity known as the parliamentary draftsman. Therefore, there are two issues here. Does the Minister not accept that we should make it clear that there should not be rewards, financial or otherwise, offered to doctors to use particular drugs? In other words, how should a doctor distinguish between a number of different alternative clinical choices if there are a number of substances available which could do what is intended by this amendment? Would the Minister not agree that we should make it clear that whatever choice is made should not in any way be influenced by material incentives? Secondly, is it not true that we should make it clear that the patient should not be offered a material incentive? One fine way of clarifying that the matter had to be fairly urgent is if the patient had to be willing to accept the prescription of this substance because he or she was convinced it was in his or her own interest without any financial incentive of any kind.
I do not want to launch into a tit-for-tat with Senator Conroy about multinationals and his apparent immutable obsession with my apparent attachment to State companies, but he should read my speeches sometime instead of reading his own versions of them. I do think, incidentally, that penicillin was not discovered by a multinational.
It was not discovered under a state system.
I am not sure who was funding the laboratories. The multinationals have a far from savoury record in most of the areas they are involved in. They need to be carefully regulated.
There are two parts to my amendment. One is to do with making sure that doctors are not affected by incentive. The second is to ensure that no financial incentives are offered to patients. We can discuss the principles of the amendment and then, if there are inadequacies in the way I have drafted the amendment, we can either have a redraft for Report Stage or the Minister can ask his draftsmen, these people of apparent infallibility, to redraft it and he can introduce the amendment in the other House. There are plenty of procedural steps still available to us. This is not the Final Stage of a Bill late in July or early in August. This is the first detailed discussion of a piece of legislation which, like every piece of legislation, is capable of improvement. There is no reason alleged inadequacies of wording should be used to avoid a discussion on the principles of the amendment, which is that the doctors would never be paid by companies to do these sort of trials and secondly, the patients should never be paid to accept or to undergo these sort of trials. The simplest way to ensure they will only be done when they are urgent is simply by having to rely on the goodwill of the patients to undergo them.
First, I take the Minister's point about the paid practitioners, the paid medical personnel, but I urge the Minister to take on board the principle of trying to avoid direct payments from pharmaceutical companies to medical personnel. If the Minister would agree to the last suggestion of Senator Ryan to have it looked at again by the draftsman it would avoid a situation where paid medical personnel or research personnel are affected. I commend to the Minister the suggestion that we avoid a situation where any commercial interest could impinge on medical personnel in hospitals or in any clinics. I believe, on balance, arising from what Senator Conroy said, that most proper medical personnel — I know we are not talking about unethical behaviour here, we are just talking about normal commercial incentives — and most outstanding practitioners would avoid this kind of thing. It might be worth while. I urge the Minister to amend the Bill to avoid the situation where that would happen.
The principle of the amendment has survived the criticisms of Senator Conroy although I have to say that, like Senator Conroy, I was also rather surprised at the size of the inducements apparently offered to Dr. Robb in the past. I do not think this surprise should lessen indignation at the violation of an important principle by offering these kind of inducements precisely because it could lead to the use of one drug rather than another. I do not really quite share the admiration that Senator Conroy — perhaps I am misinterpreting him — appears to have for multinational corporations. The reason they are an easy target is because they are an obvious and very appropriate target. I would welcome a more appropriate occasion to ventilate my views on multinational drug companies and the price which patients in this country have to pay for the unscrupulous practices of those pharmaceutical companies. This does not come necessarily from an ideological position on the left, although I would not be ashamed of being included on the left of the spectrum.
The principle remains. I do not think this will be pushed to a vote. Obviously it would be rather futile. Maybe it will; I do not know. I shall wait and see, as I have been cautioned by Senator Ryan. If it is pushed to a vote it is unlikely it will successfully pass into the main section of the Bill. It may be just a demonstration of seriousness by the Senator if he wishes to push it to a vote in due course, as is his right. It seems to me that in everything said the principle remains sustained by the debate rather than impugned by it, that the introduction of a profit motive in these circumstances is quite inappropriate.
I was present in this House for the long debate on the 1986 Act and 1987 Act and also present for the entire contribution of the former Senator John Robb. We are on dangerous ground by putting too much emphasis on it because I was in the Chair the evening of that address by Senator Robb and he would not agree with us this evening that such emphasis should have been put on what he said. He was merely making a point.
Senator Brendan Ryan tells us about his association with the medical world, about his brother and his wife, and then he goes on and says he does not trust them, that they would take a kind of backhand or they would be paid money that perhaps they should not take. I do not think if somebody was ill you would have to pay them to accept something that would cure them. As the Minister has just said it sounds fine as Senator Ryan made his case, and this amendment it appears should immediately be accepted by the Minister but if you understand the Bill and all that has gone before it and realise it only is amending a massive piece of legislation that needed amendment, I do not think it is necessary. Again, I have to defend the former Senator Robb because I do not think he intended the emphasis Senator Norris has just put on his contribution.
Nobody except Senator Honan mentioned the patients. We have heard very little about them. One of the problems about the amendment as it stands is that it is not just talking about people who are suffering from AIDS, for instance. It is a general amendment to the Clinical Trials Act which exempts all systems where a substance is administered and the principal purpose of that administration is to prevent disease, etc. All administration of substance where that applies are exempt from all the provisions of the Clinical Trials Act. It is not a clinical trial as defined by the Act. That means that you do not have to give the same amount of information to somebody that you would have under the Clinical Trials Act. You do not have to go through all the rigorous procedures to establish consent that you would have to do under the Clinical Trials Act. All of that is excluded.
I have no problem with legitimate medical practitioners, in the pursuit of the welfare of their patients where they believe on their clinical judgment that the use of an otherwise untested drug would have the possibility of doing some good. That clinical judgment should be taken clearly and simply on the basis of the merits of the case and how it would be of benefit to the patient without any extraneous influences.
I am a little bit confused by Senator Honan's reference to my family connections. I attempted to introduce a Bill into this House which would have us register all of our interests in public and it was the Members opposite who would not even let me print it. I have a habit of trying to do, as far as I can, what I believe everybody else should do, which is to state an interest where an interest may well exist so there cannot be any apparent conflict of interest. I have no problem about stating my connections but I will not allow them to influence my judgment.
I do not think that most doctors most of the time will do things that are wrong. All of us in our various professions — I include myself in both my profession as a politician and in my profession as an engineer — are often lacking in perspective about the closeness of the relationship between ourselves and commercial interests who want us to do a particular thing, to buy a particular product or to use a particular product. It needs the scrutiny of the public at large. That is why we, in our profession as politicians, are perpetually subject to public scrutiny to make sure that we keep a proper perspective in the way we are influenced by various groups. If we are to be subject to that scrutiny it is equally true that members of the medical profession should also be subject to that scrutiny.
I have no problem about having a vote on my amendment because if by any chance it is inserted the Minister will have at least four opportunities to amend the wording of my amendment if he is unhappy with it. He can do it on Report Stage this evening if he wants, he can do it on Committee Stage in the other House, he can do it on Report Stage in the other House. He has plenty of time. If he wants to, he can recommit it because they do that from time to time in both Houses. There is no problem about the wording. The problem and the issue is the principle of the amendment, that we should make it publicly clear that no clinical decision about the administration of a substance to a sick person could ever be affected by rewards or incentives offered to the doctor or by rewards or incentives offered to the patient. That is the principle. The details of my wording are a secondary issue.
Could I just re-enter the list very briefly, particularly because I was challenged to a certain extent, and certainly chastened by Senator Honan because of my unavoidable absence in the debate which took place before I was elected to the Seanad. I have taken the trouble to check what Senator Robb said. I would like to tell the House that Senator Robb made quite a short speech but he devoted two out of seven paragraphs to precisely this issue, in other words, about 30 per cent. They are not very long and I would like to read them in to the record of the House so that we may have the benefit of this. It is clear from reading the record of this debate to show how relevant they are. Being an academic, I am sure Senator Conroy understands the importance of context being academic. I understand it very clearly. I have just been reading a paper on context in James Joyce in Monte Carlo——
The Senator is admitting there are academics——
Acting Chairman
Will the Senator stick to the amendment?
I beg your pardon.
Acting Chairman
James Joyce in Monte Carlo is irrelevant to this debate.
With a certain mental agility you can make almost anything relevant but I will not be tedious.
Acting Chairman
Will the Senator proceed on the amendment?
I would like, first, to preface it by saying that whereas I was surprised at the measly amount of £10, I think the principle survives. Senator Robb makes it clear that this inducement was offered to him in 1977 when £10 sterling was worth a good deal more than it is today. This is what he says:
I should like to start by holding up for the attention of the House a £10 cheque which I was sent in 1977 and unlike those from Seanad Éireann it has not been cashed. That £10 cheque was sent to me with an accompanying letter from a drug company saying that as promised, they had despatched to me free of charge 4 × 10 one ml. ampoules of a particular drug, together with a supply of coded patient record cards; that these had been sent to the hospital pharmacy marked "For your attention" and that they had asked the pharmacist to let me know when they arrived. They went on what they had pleasure in enclosing a cheque for £10 in payment for my registration fee, and confirmed that for every ten completed patient cards received by them between then and 31 March, a further payment of £15 would be made to me.
Acting Chairman
For the clarification of the House will the Senator please identify the quotation.
It is volume 114, column 57 of 1 October 1986. That is important because it actually addresses the principle that Senator Conroy raised that there are certain circumstances where there are administrative burdens placed on the physician and that this is a legitimate compensation for them. This is clearly an argument that could be sustained from that first paragraph. It is particularly important to look at the second paragraph where Senator Robb makes it clear that he does not accept that this is justifiable. He continues:
That is inducement of the worst sort. No matter how well disciplined, no matter how professional we try to be, that is temptation handed to one on a plate. I was not subjected to any ethical committee, nor was there any suggestion that there should be an ethical committee——
This is precisely the situation we are dealing with here. There is not intervention. This is an attempt, I think quite properly, to allow a short cut so that patients can receive the best possible treatment. Ethical committees have been established in the main part of the Bill. They were discovered to hold up the process of making certain treatments available and so, quite appropriately, the Minister is introducing a short cut but it does cut out the ethical committees. Here is the nub of the point Professor Robb was addressing. I continue now with the quotation:
——had I chosen to accept the cheque and get on with receiving the £10 notes in rapid order. The irony is that that drug has now turned out to be a very successful drug and is in wide use. Here, is the dilemma. How does one obtain the research in order to ensure that drugs are safe, and while one is doing this research, how can one ensure that the motives of the researcher and of those that are promoting the research are such as to ensure that the target of their research is going to have the research done on him safely? That is what we are discussing here.
That, I think with the greatest respect, addresses the situation quite centrally.
I have no doubt that Senator Conroy, for whose intellectual elegance I have learnt to have great respect, is capable of producing yet another argument in defence. Since the Government side are claiming the virtues of academic wisdom, let me retreat to the plain people of Ireland and the university of life and say that, even if Professor Conroy does produce an opposite view, let us remember that when doctors differ, patients die.
I will deal with Senator Norris' point first. When I heard him mention the £10 earlier in the debate I thought perhaps we might have a case to answer but, having listened to him quote liberally from Senator Robb, I do not think that is the case. In fact, what happened with Senator Robb was that it was counterproductive for the pharmaceutical firm to approach the doctor in that way and it created a dilemma for him, as it would cause a dilemma for all doctors in practice. What Senator Robb was referring to was a clinical trial. In what Senator Norris quoted from he was referring to research and to a clinical trial; he was not referring to what we are referring to here, which is using a drug for a life saving purpose on an individual patient. It is the fundamental relationship between a doctor and his patient. I do not think it is necessary to write into legislation a protection to ensure that the doctor would not be motivated to use a drug that would not be in the interest of his patient because he got a financial inducement. If that were to happen there is plenty of protection already in law, through the Medical Practitioners Act. In my view it would be a very serious offence and a very serious breach of a doctor's responsibility if he were to use a drug that was not in the interest of the patient because there was a financial inducement.
Senator Ryan referred to the fact that there might be several drugs and that the doctor might be influenced to select one of them. Again, the case we are thinking of in this part of the legislation is the patient who perhaps is terminally ill, and this is a drug that has been introduced as a lifesaving drug. If there were a number of drugs that would have the same effect then, in my view, there would be an obligation on the doctor to select a licensed drug, and if there were several drugs on the market, presumably some of them would be licensed. We are talking about a drug where there would not be an licensed equivalent and a doctor would be using it expressly as a lifesaving drug for the patient. The fact that it is in the course of normal medical treatment makes it highly unlikely that there would be an inducement to the doctor to use the drug for that particular patient. While we all agree with the principle, the doctor should not be influenced by an incentive to use a particular drug. Under this registration the deciding factor should be whether the drug is in the interest of the patient. I do not see any necessity for the amendment.
Acting Chairman
Is the amendment withdrawn?
Not yet; we will not have much time left with it anyway. If the Minister thinks there is no problem then, given what I believe to be a reasonable degree of public concern the simple thing to do is to accept the amendment. It will not inhibit anybody, it will not cause any problems. Senator Robb made the point that people were offered incentives. The public — this is a point I made on Second Stage — are increasingly sceptical of all professions because they have watched the profession of engineering, of which I am a member, the general area of science, devastate the environment of half the world and been assured, as it was happening, that it was not happening. It was only when the evidence virtually stood up and hit the scientific community between their eyes that they discovered that the world had a thing called the environment which was under serious threat from the actions of science and technology and runaway consumption by western society.
The public are entitled to be reassured that all of the provisions are there to protect their well being. Every clinical trial, whether under the old Act or the Act as amended, must be conducted by a registered medical practitioner. It does not make sense to me to use this argument about the magnificent ethical commitment of every doctor if, on the one hand we produce a complex Control of Clinical Trials Act to regulate the conduct of clinical trials and of registered medical practitioners, and then say, of course, when they are operating under section 6 (2) as amended they will all behave with impeccable judgment and there will be no problem.
If we could rely so absolutely on the judgment of the medical profession, collectively and individually, we would not need the Clinical Trials Act at all other than to say they must all be conducted by a registered medical practitioner. They can all be relied upon apparently, according to Senator Conroy and the Minister, to do everything perfectly well. The truth is they cannot, which is why we have a Clinical Trials Act. If they cannot then we should carry the logic through and we should ensure that in this case where they are not conducting a clinical trial none of the trappings of the clinical trial, i.e., material incentives for the doctor or patient should be involved. It is not a clinical trial and we regulate them even if they are doctors because we know that everybody is human.
It seems to me there is no conflict between this amendment and the Bill, its intention and purpose so it would be possible to take it on without doing any damage. I do not think anybody's conscience would be violated by so doing. I would like to make one further point, that is, I noted there was an attempt to bring former Senator Robb's argument into support of the Government's reluctance to accept this amendment by saying that he was actually illustrating the Government's point. Far from it. It is perfectly clear and he was quite unambiguous about it. He said: "That is temptation handed to one on a plate. This is inducement of the worst sort." There are two quite unambiguous statements: inducement of the worst sort, temptation handed to one on a plate. You may disagree with the former Senator. You may be surprised that even in 1977 a sum of £10 would represent any inducement to temptation at all but there is no question of ambiguity in what he was saying. He was saying that it was wrong in principle and it was something that he was very concerned about.
I appeal to the Minister to give at least some indication that he will consider this. It should cause no difficulty philosophically. It does not attack or undermine the principle of the Bill at all. Senator Ryan's point is very well taken that legislation of this kind does not deal with the 95 per cent of doctors who are perfectly all right. It seeks to close out the option for that small minority who may be liable to corruption.
I do not understand how Senator Norris can say that what he has quoted from former Senator Robb does not in some way support the Government's case. After all, this afternoon we have just one case before us where a pharmaceutical company offered a doctor an incentive to use a drug for cash and that was resisted. We have no case where a doctor used a drug that was not in the interests of the patient, and, in fact, we have no case presented to us here this afternoon where a doctor was offered an incentive cheque and cashed the cheque or accepted cash in any other form. The only illustrated case we have here before us this evening is from former Senator Robb quoted in the Seanad. That case was one which in my view represents what is likely to happen, that it is likely to be counterproductive for the pharmaceutical industry.
I am interested that this amendment is being introduced as an addendum to the amended section 6 of the Bill. In section 2 of this Bill we are just clarifying what is already in the original Bill. Section 6 (2) (a) (ii) of the original Bill stated: "The principal purpose of that administration is the welfare of the patient." The new subsection is just to clarify what we mean by the welfare of the patient. When the legislation was going through this House in 1986 and 1987 no such amendment was included in it. When it was implemented in 1987 and the early part of 1988, there did not appear to be any need for such an amendment. I still believe there is no need for such an amendment.
Acting Chairman
Is the amendment withdrawn?
No.
Question put: "That the words proposed to be deleted stand".
The Committee divided: Tá, 29; Níl, 18.
Tá
- Bennett, Olga.
- Bohan, Eddie.
- Byrne, Hugh.
- Byrne, Seán.
- Cassidy, Donie.
- Conroy, Richard.
- Cullen, Martin.
- Dardis, John.
- Fallon, Seán.
- Farrell, Willie.
- Fitzgerald, Tom.
- Foley, Denis.
- Hanafin, Des.
- Hederman, Carmencita.
- Honan, Tras.
- Hussey, Thomas.
- Keogh, Helen.
- Kiely, Rory.
- Lanigan, Michael.
- Lydon, Don.
- McCarthy, Seán.
- McGowan, Paddy.
- McKenna, Tony.
- Mullooly, Brian.
- O'Brien, Francis.
- Ó Cuív, Éamon.
- Ross, Shane P.N.
- Ryan, Eoin David.
- Wright, G.V.
Níl
- Cosgrave, Liam.
- Costello, Joe.
- Doyle, Avril.
- Harte, John.
- Howard, Michael.
- Jackman, Mary.
- McDonald, Charlie.
- Naughten, Liam.
- Neville, Daniel.
- Norris, David.
- Ó Foighil, Pól.
- O'Reilly, Joe.
- O'Toole, Joe.
- Raftery, Tom.
- Ryan, Brendan.
- Ryan, John.
- Staunton, Myles.
- Upton, Pat.
Tellers: Tá, Senators Wright and Fitzgerald; Níl, Senators B. Ryan and Norris.
Question declared carried.
Amendment declared lost.
In accordance with the Order of the House, I am required to put the question: "That the Committee Stage is hereby completed and the Bill reported without amendment, Report Stage is hereby completed and the Bill is hereby passed."
Question put and agreed to.
Sitting suspended at 6.10 p.m. and resumed at 6.30 p.m.