We will deal with amendments Nos. 1, 5, 8 and the amendment to amendment No. 8. Amendments Nos. 9, 11, 12 and 22 are related. Amendments Nos. 10, 14, 15, 16, 19, 23 and 38 are consequential on No. 9. Amendments Nos. 8, 9, 10, 11, 12, 14, 15, 16, 19, 22, 23 and 38 may be discussed together. If No. 9 falls, Nos. 10, 14, 15, 16, 19 and 38 cannot be moved. All these have a bearing on the National Advisory Council. I can go through them again and again.
Control of Clinical Trials Bill, 1986: Committee Stage.
SECTION 1.
I can understand the Chair's dilemma because of what has happened, but we have a Bill with 18 sections and 59 amendments. Some of us, including myself, were saying to the Minister that he might withdraw the Bill and rewrite it, but the Minister decided he would not do that but amend it. I will have to give credit to the Minister. He has come a long way to meet many of the problems raised in the Seanad; he has endeavoured to meet the criticisms made of the Bill.
In my own case, many of the amendments from the Government side will meet my aspirations. I wish to thank the Minister for that. Much of what is in the Bill now is acceptable, which was not the case when the Bill came into the House first. I congratulate the Seanad on the great effort, work and interest shown. There was an astonishing amount of interest in this Bill right across the board. Obviously, the medical people helped but the general public, too, are aware of the importance of this Bill. I have a vested interest because I had cardiac surgery and I am riddled with arthritis. I am interested in anything that will produce good drugs and good medical research in the future which will help my own individual cause.
Every man, woman and child in Ireland should have an interest in the Bill. It will affect their lives in some way because medical research is vital to this nation and this Bill is vital to medical research. The Minister has gone a long way and for that I am grateful.
In opening——
There has been no opening. I was waiting for amendment No. 1 to be moved.
I move amendment No. 1:
In page 3, subsection (1), between lines 23 and 24, to insert the following:
"‘the Board'means the National Drugs Advisory Board;".
This has been tabled because of certain arguments, but the Minister has taken care of them. I may withdraw it.
Does that make it impossible for us to make opening comments of the sort Senator Fallon made?
No. I was waiting for amendment No. 1 to be moved.
My whole thinking was to have a formal recognition of the National Drugs Advisory Board, that they would be referred to specifically and have formal mention in the Bill. That is not in the Minister's amendment.
Amendment, by leave, withdrawn.
Question proposed: "That section 1 stand part of the Bill".
Briefly, on the section, I appreciate the points made by Senator Fallon and I have endeavoured in recent weeks — and this has been one of the reasons I have not had the opportunity to meet individual Senators arising out of the Second Stage debate — to accommodate to the greatest extent possible the incorporation of the NDAB in the framework of the Bill. I appreciate the support of Senators.
I wanted to deal with the reference to the NDAB made in amendment No. 1, which has been withdrawn, and which was mentioned by the Minister. Many of us were very complimentary about this voluntary organisation, a non-statutory body. I am concerned about giving this organisation statutory powers. Like Senator Fallon I am pleased that they are specifically mentioned in legislation. It will give them a consultative role vis-à-vis the Minister. They will have a useful role to play in the future in the area of clinical trials. From what the Minister has said in discussions I take it that the board we will be referring to in the future will have statutory powers vested in them by this legislation and because of that members of the National Drugs Advisory Board will be on the new board. I take it the new board will be a statutory board and not a voluntary board as is the case at present.
The Minister will have consultations with them and they will advise him. When we talk here about a board we are talking about a new control of clinical trials board as opposed to the non-statutory role the National Drugs Advisory Board play now in a very capable manner. I am anxious to ensure that they should have a responsibility, apart from the Minister, in various areas, that they will have a statutory role and will be accountable to the Houses of the Oireachtas.
The Minister has been forthcoming and obviously attentive to the contributions of Senators in the Second Stage debate. We have pages of Government amendments, not to talk about the amendments from Members of the House. To that extent it is a little difficult to understand where we are from time to time. I hope the Cathaoirleach will bear that in mind in the course of our contributions.
I could not do anything about it. Amendment No. 1 should not have been withdrawn until it was discussed. I am not blaming you Senator Fallon. I have decided to let all the amendments go together.
I refer in my amendment to "the Board" and I am simply saying that the Minister should refer to them as the National Drugs Advisory Board. From that point of view, he does not have to put in section 1.
You would have helped me much more if you had not withdrawn it. We are dealing with amendments Nos. 1, 5, 8, and the amendment to amendment No. 8. Amendments Nos. 9, 11, 12 and 22 are related. I said this is very complicated. Amendments Nos. 10, 14, 15, 16, 19, 23 and 38 are consequential on No. 9. Is everybody clear on that?
Perhaps you would not go any further than that at this stage and we could deal with it one section at a time in order to minimise confusion. I do not know whether other Senators would agree that we should take the first grouping first and then proceed with the others.
Because they are related, they can all be discussed together and if any problem arises as we pass through the amendments, I am quite prepared to listen.
If amendment No. 1 falls, all the others fall?
I said if No. 9 falls, Nos. 10, 14, 15, 16, 19 and 38 cannot be moved. All these amendments are being discussed together but I will put them separately when their turn comes. Does that ease the situation? I have more that are tied up with No. 1. Amendments Nos. 5, 8 and amendment to amendment Nos. 8, 9, 10, 11, 12, 14, 15, 16, 19, 22, 23 and 38 may be discussed together now. We will discuss them all together.
I find that what I was going to speak on, although it is stated that it is to be inserted at the end of section 1, has been included in section 2 so I do not think it arises now.
Would it be possible to make a general comment on the bringing forward of the amendments by the Minister? I think it is true to say the Bill was initially too comprehensive and that the amendments have been very welcomed by all the people who have been keeping a very close eye on this Bill. The Bill has excited not only national interest but international interest, and the vested interests in particular were to be found with ruffled feathers when this Bill was first published. The amendments that have come forward from the Minister, even though they will cause us some confusion as tabled, will have the net effect of strengthening the Bill.
As the Bill was originally drafted, academic medicine was most apprehensive about the application of the provisions to its work. In general those interests will be very pleased, indeed, with the amendments which have been brought forward. The National Drugs Advisory Board, who played a key role, have been very firmly brought into the Bill, as Senator Fallon said in his opening remarks. I would like to say how very much I welcome that and I think it strengthens the measure before the House.
I thank Senators for their observations. I feel satisfied that we should incorporate the formal role of the NDAB within the framework of the Bill and, despite the complex effect that will have on the various sections of the Bill, I think we have managed to marry them in effectively today.
Would the Minister explain to me the role of the National Drugs Advisory Board prior to the introduction of this Bill? They have a specific role of making recommendations to the Minister, though when we went through the original draft of the Bill on Second Stage, I suggested that the Bill should be withdrawn and redrafted. I think that there was and still is a legitimate reason for my saying that on that occasion, and the answer is here today: it would have been easier for all involved if that had been done. On that occasion I said the Minister has always been favourable to amending legislation but what I am asking the Minister on this section is: what change is there now in the role of the National Drugs Advisory Board as against the role they had prior to the introduction of the Bill?
There is a statutory assurance formally written in which did exist but is now a statutory assurance that the role of the NDAB is enshrined in the Act and the Minister, being the competent authority, in future will consult with the NDAB prior to exercising that authority. Heretofore, the NDAB operated a voluntary scheme of regulation. After this, the controls will be formal but will be substantially based on the voluntary scheme. However, the board will be given statutory authority. The only person who can exercise authority is the Minister for Health of the day, and he will do so now after consulting with the board.
Apart from the change from the voluntary to the statutory, is the working of the board changed in any form? Apart from the actual naming of the board, and giving them a statutory role will the actual working and the procedures to be adopted by the board relative to the request of the Minister be changed in any way?
The procedures of the board are well established and they will not be affected, but the board will have the statutory backing which was not there up to now.
I cannot see what it will do for the Bill but it will help possibly to make progress in the discussion here and if the Chair wants me to leave it in for that purpose I will do so. The Minister gives the board their full title. Is he satisfied that it is not necessary to insert in section 1 the type of amendment I put down? If he is he might like to do it later on.
We have no great preoccupation about that because, as the Senator knows, the NDAB exist by way of statutory establishment order already so that they would be defined as such.
Question put and agreed to.
NEW SECTION.
Government amendment No. 2:
In page 4, before section 2, to insert a new section as follows:
2. — (1) (a) The provisions of this Act shall not apply in respect of any clinical trial which is being conducted at the commencement of this Act.
(b) Where any arrangements to undertake or to conduct a clinical trial were or were being made before the commencement of this Act and where paragraph (a) does not apply, then such arrangements shall, for the purpose of an application under section 3* or of section 10, be treated as if they had not been made otherwise than in accordance with section 3 or 10 (as the case may be).
(2) Where a person proposes to arrange for the conducting of a clinical trial or to conduct a clinical trial and there is in force in respect of the substance or preparation concerned a product authorisation granted under the Medical Preparations (Licensing, Advertisement and Sale) Regulations, 1984 (S.I. No. 210 of 1984), then the provisions of section 3 to 11 shall not apply where —
(a) the National Drugs Advisory Board—
(i) have been notified in writing of the proposal, and
(ii) have received such information, evidence, documents, samples or other materials that they may have, not later than 4 weeks after being so notified, requested in relation to the proposed clinical trial, and
(b) the conditions under which the product authorisation was granted are complied with in respect of the substance or preparation concerned."
This is to insert a new section before section 2 of the Bill as published. I am introducing this amendment to take account of some points made in representations received since the publication of the Bill and to take account of the contributions of some Senators on Second Stage. The purpose of this new section is to provide for an exemption from the controls in the Bill of clinical trials actually in progress prior to the enactment of the Bill.
There will be an overlap. We do not propose to cover the overlap at this stage because there are considerable statutory problems. It also ensures that arrangements for clinical trials which had not started before the commencement of the Act are not invalidated. The Bill provides that such arrangements, so to speak, should be preceded by the granting of permission to undertake a trial. The exemption of trials where the drug being tested has a product authorisation, provided that the NDAB have been notified of such trials, is to meet objections that the Bill would otherwise make it impossible to carry out any studies which are important in the public interest because of the procedures required, including unrealistic insurance fees, cumbersome and protracted consideration of applications and the possible setting up of the medical practitioners involved for claims in respect of alleged harmful effects. I use the phrase "setting up" advisedly.
It is maintained that the ordinary ethics committees and the general insurance arrangements take care of those matters as it is. However, while it is accepted that there is a case for relieving such trials from the full controls envisaged originally in the Bill, it is important to ensure that the authorities are aware of the details of such trials. It is with that in mind we consider this new section necessary. It may be suggested that we are watering it down. We are not; we are trying to avoid an overlapping with trials, currently in operation, and these could not be brought within the framework of the Bill. That point has been made in a reasonable way in relation to the Bill as first published.
I move amendment No. 1 to amendment No. 2:
In subsection (2), to delete paragraph (b) and substitute:
"(b) Where the conditions under which the product authorisation was granted are not complied with the National Drugs Advisory Board may if it considers necessary attach modifications or conditions under which the trial may proceed in respect of the substance or preparation concerned."
For those following this debate either by way of report or in the press gallery today I should make it clear that my amendment relates not just to the original Bill but more directly to the Minister's amendment. I propose to add a subsection dealing with the role of the National Drugs Advisory Board in situations where modifications or conditions could be introduced under which a trial may proceed in respect of a substance or preparation. I would like to read a short portion of a letter which I received today from Professor John Feely, Professor of Pharmacology and Therapeutics in the University of Dublin, Trinity College, on behalf of the Joint St James' FDVH Ethics Committee. TCD Health Sciences Faculty Sub-Committee on the Control of Clinical Trials Bill.
The letter relates in particular to section 2 and to the amendment to the amendment we are discussing. I might add that this letter is directed to the Minister of Health. He may not have had an opportunity to see it. It only arrived in the post to his Department this morning. Dealing with section 2, the letter states:
We welcome the exclusion of drugs that have a product authorisation from the full rigours of the Bill. While this amendment would make it unnecessary to receive Ethics Committee approval for such studies we feel that all such studies should have Ethics Committee approval and, irrespective of the legislation, undoubtedly our institutions will insist that all clinical research will have Ethics Committee approval.
There will, however, continue to be some problems with regard to drugs that have a product authorisation where their use in research will be in keeping with everyday clinical practice but different from the original product authorisation. The difficulty here is that product authorisations when initially granted are understandably extremely restrictive. With more clinical experience the use of a drug increases considerably and sometimes in a more practical manner. Product authorisations may be 5-10 years behind clinical practice and frequently pharmaceutical companies do not update the Data Sheet. Take for example the beta blockers.
A study involving propranolol in mild portal hypertension (as used by some gastroenterologists for a number of years) or a study involving the use of a beta blocker following a myocardial infarction but commencing treatment on day 3 or 4 (authorisation indicates commencing treatment between days 5 and 21), or using propranolol in combination with verapamil (as is often done nowadays) or a study in thyrotoxicosis giving propranolol in adequate dosage (rather than the small doses recommended in the initial authorisation) would all have to undergo the full rigours of the Bill. We suggest that such studies should instead require approval from the National Drugs Advisory Board who may attach to that approval any modification or conditions under which the trial may proceed, and that such studies will require Ethics Committee approval. Thus all studies involving drugs that have a product authorisation could be processed by the NDAB.
What I am saying in everyman's language rather than in the medical terminology used in the letter from Professor John Feely is that I understand propranolol, if I have the word correctly, was originally given authorisation under the Medical Preparations (Licensing, Advertisement and Sale) Regulations, 1984. That drug was originally authorised for the direct purpose of dealing with heart disease whereas it is being used nowadays in relation to controlling blood pressure. It is being used widely in medical practice for this purpose. We want to minimise the extent to which doctors in medical practice will have to go for detailed approvals and long periods of doubt about a drug currently in use, or where medical science has seen that it could be effective in another area of handling patients in a hospital. For that reason I suggest that the amendment to the amendment makes sense and tidies up the Bill in the interests of those involved in the treatment of patients.
There are some who would water down the situation to the extent that they would feel free to develop new processes, new clinical trial procedures without reference to the NDAB. There is nothing to prevent anybody who has received an authorisation from going back and having additional criteria added on in certain circumstances. It is open to the persons conducting the trial. It is essential that we should have this. The new section 2 is quite explicit. It allows a clinical trial to proceed involving an authorised drug which is being used for specific purposes. I can see the reluctance of some people, including those involved in well established drugs, to vary the trial or vary the purpose therefor. To loosen it out in this way would, in effect, negative the general purpose of the controls. Our view, shared by the NDAB, is that when they attach conditions which relate to the use of an authorisation, they are usually framed in such a way that if the professor or the clinician concerned wants to come back and have additional uses in certain circumstances added on, he can come back within the framework of the authorisation. He does not have to go through the whole new procedure again.
For that reason it is important that the Senator should have raised the point. We have received representations regarding this aspect but it would open it up unduly and I am not so sure te NDAB would want that. That is my feeling. I am always chary of one letter from one academic who understandably has a particular viewpoint which might not necessarily be shared by the members of the board. It is in that context that I appreciate the point being made. Additional use in certain circumstances can be added on to the authorisation.
Are we talking about the need for the Minister to expound on the up-to-date position of doctors in medical practice — clinicians — in relation to drugs in a hospital rather than dealing with drug companies exploring new drugs? I am talking about an existing drug approved by the registration process and being used for a different purpose. Does this mean in the case of propranolol that all those involved or the company manufacturing this drug, will now need to go to the National Drugs Advisory Board to get the product authorisation changed to allow for the application that deals with controlling blood pressure? Is that what the Minister is saying to the House? When this Bill is passed this will be a necessary step for those engaged in producing this drug or for those using it to ensure that the drug company, or whoever is responsible, does it.
It is essential for the safe housekeeping of the NDAB and the knowledge of the NDAB that they should acquaint them with the additional uses to which this authorisation is being put. I have a problem in the context of litigation on the use of drugs and I have to protect the NDAB. The Minister for Health of the day has to ensure that he does not finish up with massive litigation against him because he takes a degree of statutory authority to himself and could finish up in a few years' time in dire trouble if he were to loosen it out unduly.
In relation to the established position the user concerned would be obliged within the framework of the Act to notify the NDAB office of all traditional usages and I do not see, once they have that acquaintance, that they would require it to go through a new clinical trial because of the established authorisation there already. As the Senator is aware we propose to exempt trials involving authorised drugs provided they are being used in accordance with the condition of the authorisation. That is our change at this stage of the Bill. It is a very substantial and reasonable change and is one which, by and large, they have welcomed.
Notwithstanding anything I have said, there is still nothing to prevent a medical practitioner using his own clinical judgment and taking it upon himself as a matter of personsl decision to use a particular drug or substance in a particular way, and he must take the responsibility for it. If he is involved in a trial then the role of the NDAB comes in and within the framework of the Act, he would be obliged if he is using a drug not covered by the authorisation to notify the NDAB of the proposed additions. I think he would be exceptionally well advised to so do knowing the concept of litigation these days.
There are two things I should like to explore further. The Minister talked about the user. The user, I presume, means the medical practitioner. Perhaps the Minister does not want me to explore this point much further. I asked earlier whether the drug company would have to get involved in ensuring that the authorisation was changed or altered, or whether it falls on the medical practitioner. I do not know whether it is important to get this matter defined further. The Minister talked about the trial. Presumably there is a grey area between the patient suffering from an acute illness in bed in a general hospital and the person presenting himself for a clinical trial, presumably paid for by a drug company. Is there any way of measuring — or who measures — the distinction between one exercise and the other? There probably is an element of drug trials in medical practice, particularly in dealing with terminal illnesses in hospitals where it is decided there is a drug that just might do what is required. I lived in a medical household for a long time.
The point I am trying to make is that one often hears about a new drug which may do what is required. These people are racing against time in trying to save the life of somebody in an acute stage of illness. I wonder where the line is drawn between actual medical practice and trials in a hospital. I see no difficulty when one is dealing with the establishment of a new drug and a drug company's involvement in trials. In the area of medical treatment I wonder — I mean medical treatment in relation to patients who are suffering a great deal, who are perhaps terminally ill, where doctors have almost given up hope of saving the life of the person concerned — if there is a drug that just might do the trick, having been tried successfully in Canada or the US, can it be used? That is the question I would like to pose to the Minister.
I would not have a great deal of difficulty in replying in this framework. If the patient concerned has a terminal condition and the practitioner concerned, using his clinical judgment, decides to avail of a complex range of drugs in a last ditch effort and he does not succeed, full stop, he does not succeed. If he does succeed, he does succeed. If he is in consultation with a drug company and simultaneously he is completing a trial charge and, as happens very frequently, he is being paid when he uses that drug, he puts himself into a trial situation and then the role of the NDAB comes into play, in so far as an authorisation is concerned. In relation to acute arthritis — I am familiar with rheumatoid arthritis as a member of my own family had the condition for many years — he would avail of the most up-to-date substance and, provided he does not embroil himself or involve himself in a trial situation, he is totally exempt from the rigours of the Bill.
That is important because we could not impinge on ordinary medical practice to a major degree. Therefore a doctor, practitioner or consultant has virtually unlimited authority for the use of a drug in that framework. He may report back to the drug company that it looked like being the wonder drug for acute arthritis and at that stage the company would have to apply to the NDAB for additional usages. It would be incumbent on them, and that is why it has been a very difficult Bill to frame. Now that the pre-occupation of Professor Feely, whose competence I would in no way question, is met within that framework, our elaboration here today should put that to rest. They are understandable fears which may academics have. They want academic freedom and I am in favour of academic freedom in a responsible way.
Arising from what the Minister and Senator FitzGerald said, is the role of the National Drugs Advisory Board a positive role? Have they not got a positive role to play? From what Senator FitzGerald has said I understand he is talking about a drug that might come from England, America or wherever, and a medic might decide to use it for acute arthritis. At that stage has it not in some way been investigated and passed by the National Drugs Advisory Board because they have done so in the past? We know of certain drugs which were in use in England and other countries and were withdrawn, but were not allowed into Ireland by the National Drugs Advisory Board because they were aware of what was happening. They were on the ball, anxious, competent and so on. In the case referred to by Senator FitzGerald and by a previous speaker, have the NDAB a positive role, even at this stage, to play in a situation like that?
I noted in the Minister's previous comments that he drew a very clear distinction, which was not made prior to the Government's amendments being put down, between the question of a trial being in progress and the question of a particular drug under trial in a specific situation. A private doctor may decide to use drugs in, as the Minister said, a last ditch effort to save a life. In my Second Stage contribution I mentioned drugs used for terminally ill patients suffering from leukaemia and cancer.
The previous restrictions, according to the original draft, would have prevented the use of drugs which had a product authorisation and had been recognised by the World Health Organisation and had been used elsewhere outside the country. It was felt at the time — perhaps the Minister will clarify the position — that the use of such drugs would have been prevented had they not got the clearance from the National Drugs Advisory Board. That would mean there would be huge delays involved particularly in dealing with acute illnesses. The delay in some instances would have prevented efficient effective treatment. Therefore I welcome the Minister's inclusion of the amendment. I agree with what he said in regard to the opening up of the floodgates and the free administration of drugs. If my interpretation of Senator FitzGerald's amendment is correct it makes it more easy for medical practitioners to use drugs in a hospital and in treatment rather than in a clinical trial.
I have just a few brief comments to make. Senator FitzGerald's amendment to section 2 is to be welcomed. It is a very sensible provision because it means that trials already in progress will not be subjected to any stop-start breaks which would not be in the interests of the patients who are undergoing the trials and, indeed, would cloud or mask or, in some ways, completely obviate the academic who was perhaps engaged in the trial and the end result would be of no value whatsoever. Given the safeguards that are part and parcel of the Minister's amendment it is a perfectly sensible, sane provision to allow what is already proceeding to continue.
The concerns raised by Senator FitzGerald in his amendment are very interesting ones. I listened keenly to the Minister's reply. It seems to me that the reply meets the concerns expressed by Senator FitzGerald in that it is possible to go back to the National Drugs Advisory Board and to look for an extension of the conditions of trial if an application for the drug can be given to treat something tangential but still different from the provisions of the original authorisation. In addition, it does not cut across the freedom of the medical practitioner to intervene promptly particularly in a terminal situation and to use a drug which it is felt will alleviate pain or prolong or give an added quality to the life which is in the care of the practitioner. All in all, this measure has been intelligently and sensitively dealt with given the amendments that are before us today. Certainly I found the Minister's reply adequate.
I have been listening and it took me quite a while to adjust to the complexities of the way our amendments are falling together. I would have thought that Government amendment No. 18 regarding the redefinition of the conducting of a clinical trial covered a large part of what has been discussed here. Where a drug is being administered the principal purpose of that administration is the welfare of the patient. We are not talking about a clinical trial at all and a large part of our concerns would be covered by that.
I would like to remind the House that this is not as simple as one might imagine. There is a hard sell being conducted by drug companies, often to the delight of medical practitioners who are entertained to my knowledge in luxurious restaurants in what are generally described as drug do's. They are frequent and very much a part of hospital medicine. People are not saints. We are not saints in this House. We have to operate under regulations. I would not like to leave the politics of the operation of this House to the feelings of the Members at a particular moment about what would be appropriate. We have to operate according to Standing Orders because they establish the framework within which we operate.
Similarily it is not just in the case of terminally ill patients that drugs are widely used. In the area of psychiatirc medicine there are profound ethical questions about when, where and under what circumstances drugs should be used. There are suggestions, quite legitimately made, that drugs can be a substitute for proper clinical care and can be a substitute for the time of a medical practitioner in many cases, particularly in psychiatric illness. These are drugs that are not used on a short-term basis; they are drugs that often have to be prescribed for life. This layman has a view that some of the side effects of some of the alleged wonder drugs in the area of psychiatric medicine would be a worthy area of study for the sort of high-minded medical practitioner being presented to us here as being somehow restricted by the provisions of this Bill.
There is much more to this. Part of the problem the medical profession have is the problem all the professions have: a certain resentment that the ordinary unqualified laity should claim any right to make them accountable for the manner in which they do their business. It is proper and right that there should be accountability by all professions. The only profession that is totally accountable is this profession we are involved in here, because ultimately we lose our right to practice this profession if we are not deemed to have done it properly. There is no other profession which has that degree of accountability. Other professions are perfectly free to practise incompetently as long as they are not negligent.
Therefore, I am happy with this part of the Bill. I regret, and I will say it in stronger language later on, that the lobbies on behalf of the people who may well have to undergo these trials have not caught the Minister's ear to the extent that perhaps the lobbies of the professions have done so, but that is for a later part of the discussion. The Minister has done a fine job. For a variety of reasons I have had a lot said to me about the problems that the medical profession would have about this Bill. The Minister has done a reasonable job in meeting those concerns. He has shown that he is a man of great flexibility and is prepared to listen to other people's opinions and he has amended the Bill quite satisfactorily. I would not for one second allow the sensitivities and, indeed, often the vanity of a particularly vain profession to carry us too far in that direction.
Arising out of what Senator Ryan has said, I would be the last person to wish to protect the vanity of any profession. I share his concern about psychiatric patients and the use of drugs in this aspect of the profession. I have done so for years. In former times it is true to say that psychiatric patients were put in strait-jackets and nowadays there are many people who feel that the use of the strait-jacket has been replaced by that of the chemical strait-jacket. In my former capacity as a member of the South Eastern Health Board when going into psychiatric hospitals on hospital visits — and indeed I lived on the campus of St. Brigid's Psychiatric Hospital in Ardee for a couple of years — I had an opportunity to observe this chemical strait-jacketing of psychiatric patients. It is disturbing and I would agree with Senator Ryan that very often it can be a substitute for person to person therapy and a convenient way of dampening down facets of the psychiatric patient's personality disorder, which is questionable. I do not think it acutally arises in the context of this Bill because it is not necessarily a clinical trial. It is perhaps a subject for another discussion on another Bill on another occasion. That is really a comment I felt I would like to make arising out of what he said.
An Leas-Chathaoirleach
I should call you after each speaker, Minister, but as they were all speaking on one amendment, I thought it was better not to have you jumping up and down.
I thank Senators for their observations. I have elaborated in reasonable detail on the points raised. The further issues raised are indeed of interest and are germane to the Bill as a whole. I appreciate the points made but at this stage I will let the analysis rest.
Amendment No. 1 to the amendment No. 2, by leave, withdrawn.
Amendment No. 2 agreed to.
SECTION 2.
An Leas-Chathaoirleach
Amendment No. 4 is an alternative to amendment No. 3. Amendment No. 21 is related to amendments Nos. 3 and 4 and may be discussed together.
Government amendment No. 3:
In page 4, subsection (1), to delete lines 10 to 12 and substitute the following:
"(b) sufficient information to enable a scientific evaluation to be made of the proposed clinical trial and of the substance or preparation which it is proposed to administer in the course of that trial,
(c) the identity (which includes the qualifications of each member) of the ethics committee.".
The first part of the amendment, the new section 2 (1) (b), is necessary to ensure the completeness of the dossier to be submitted in an application. The second part of the amendment, new section 2 (1) (c), is to take account of the contention of quite a number of persons that it should be possible for a hospital which carried out trials regularly to refer to its ethics committee a particular application without having to name the members each time. There would have to be an assurance that the ethics committee was constituted on an impartial basis required of such a committee in accordance with the guidelines recommended by the NDAB. This could be arranged administratively. I understand the preoccupation regarding hospital trials and the endeavour on our part not to build up a bureaucratic structure within that framework.
It was very interesting that in his reply on Second Stage on the question of ethics committees the Minister's response to the idea of a national ethics committee — which is effectively what amendment No. 21 proposes and which would consequentially necessitate amendment No. 4 — was: "Can you imagine what I would be accused of if I suggested a national ethics committee?" I can imagine what he would be accused of and I can imagine all the problems. It is worth recalling that, even though the medical profession do an enormous amount of wonderful work and an enormous amount of work to advance the cause of suffering humanity, this does not give them a sort of infallibility.
In the area of clinical trials the history in Ireland is that many groups who have had reason to observe their operation from the bottom upwards are singularly unhappy that the ethics committees appointed by the clinics, in particular, did not function as they were allegedly intended to. They failed in many cases to protect vulnerable people from exploitation by these clinics and, therefore, do not seem to meet one of the criteria of justice which is that they should be seen to be operating in an independent fashion. The only way to have public confidence that ethics committees are impartial and independent of the clinic involved is to have the ethics committee separate from all the clinics and bodies involved in clinical trials and have such an ethics committee nominated by the Minister with the power, the right and the funds because at least two of the clinics are more than in a position to fund an ethics committee quite adequately. There need not be any charge on the State.
The prospect of a number of ethics committees, or an ethics committee for each trial, will not give any sense of public confidence and will not alleviate public concern. The public have good reason to be suspicious of all the professions. They do not necessarily always operate in the interests of the public. The only structure for accountability the public have at their disposal is through the political process. It, therefore, appears to me that the only way to categorically assure the public that clinical trials are being conducted properly, ethically and without any exploitation of those who are participating in the trials, is by having an ethics committee which is independent of all the trials. The simplest way to ensure that is to have an ethics committee nominated by the Minister and that is why I put down amendment No. 21 which provides that the Minister should appoint an ethics committee to supervise all clinical trials in the State, and amendment No. 4 which follows on from that.
I would certainly like to be able to support Senator Ryan's amendment because I know he feels very strongly about it. When we examine what clinical trials are about, I accept the point he has made about multinationals, profit making and so on. What is wrong with drug companies making a profit? Deputy Noonan, Minister for Industry and Commerce, at the opening of an extension of one of these companies asked what was wrong with profit.
I cannot see how a national ethics committee would help in any way because many people in this House and in the pharmaceutical profession are worried about the obvious bureaucratic delays we were told would follow. If there is a national ethics committee in Dublin, for example, that will delay things. It will add another delay of five or six months. How could a group sitting be expected in Dublin to examine the protocols of every company who wanted to engage in clinical trials? To whom should they be answerable? In the Elan set up we have a very responsible Garda sergeant, a priest and three medical people. Surely they are answerable to themselves. If they think there is something wrong, they are fools if they do not say so and ask for further information from the National Drugs Advisory Board, or delay the trial for further information. While Senator Ryan's proposal is beautiful in theory, in practice it would not work. It might be a different matter if he said, for example, that there should be a national supervisory ethics committee who would give guidelines and distribute information down the line.
People who are members of ethics committees are answerable to themselves and to their conscience. For example, a Member of the other House, Deputy Briscoe, is a member of the ICP ethics committee in Dublin. He is one of the most independent men in the House. He is a man of integrity and concern. Certainly he will not be influenced by anybody. He has his own integrity and concern. While I share Senator Ryan's concern and know what he is getting at, if in the long term we are interested in medical research in Ireland, what he is suggesting is fine in theory but in practice I could not see it working. While I would like to support him, I cannot do so for the reasons I have given.
I want to make a comment on ethics committees. I am not so sure about ethics committees. In some instances they can work well. In other instances they can be a vehicle for particular prejudices of individuals. That is something we must always guard against any time it is suggested that ethics committees should be set up.
In section 7 of the Bill there is a provision for the approval by the Minister of a proposed ethics committee for a clinical trial. It is true to say that a central concern of an ethics committee is to ensure that the risks to the participant do not outweigh the objectives of the trial. That is something we must keep in mind when we speak about an ethics committee. My concern in relation to this is that it is the applicant wishing to undertake the clinical trial who proposes the names of the ethics committee to the Minister for his approval. This was in the original Bill. At any later date the applicant has the right to apply to the Minister seeking the dismissal of any member of the ethics committee. I was unhappy about seeing that in the Bill because the independence of an ethics committee is a key factor and is a feature of ethics committees generally. I would be interested in what the Minister has to say in relation to the matter of ethics committees.
Will the Minister actually scrutinise the membership of the ethics committee to guarantee that no institution will have their own membership exclusively? Will he guarantee that there will be outside participation so that there will be a balance of opinion as distinct from a unified group of people coming forward with the same purpose in mind is so far as they might be representing the same institution or a combination of institutions with the same interests in mind?
The nature of any ethics committee would have to be such as to require it to have a close involvement in the supervision of all aspects of any trial. On that simple ground alone it would be quite impracticable to have a national single committee to assume multiple functions. Inevitably there are multiple functions in many varying trials.
The National Drugs Advisory Board will have specifically devolved on them the responsibility of advising the Minister for Health about the ethics committee for each trial. The board and the Minister will have to be satisfied that it is a reasonable balanced trial. The ethics committee will be sufficiently impartial in relation to that trial and will take full cognisance of the primary interests of each participant in that sense. Senator Fallon and his colleagues are correct; no one committee could possibly work for all the details of all trials. While I share Senator Ryan's concern that the ethics committees should be emphatic and independent, I do not think the setting up of a national body would be appropriate under the framework of this Bill.
I do not understand some of the objections. This is not an enormous country. I am not convinced that there is an enormous amount of work that would come under the now considerably more restricted — though the Minister insists it it the same definition that always existed and is simply clarified — definition of a clinical trial. We are not talking about a huge volume of work, we are talking about two major private concerns that are commercial organisations, and presumably some of the major hospitals. That by and large is the scale of the operation of clinical trials in Ireland.
The advantage of a national ethics committee is that they will develop expertise, will develop a consistent approach on a variety of issues, will develop a philosophy about the ethics of these trials. I would be concerned that an ethics committee should be there not to preserve a particular model of religious ethics, but rather to ensure that the trial in the way it impinges on the participants is ethical and that there are no short cuts in that direction. I do not believe the amount of work involved is so considerable.
Listening to Senator Fallon, in particular, talking about the bureaucracy, it is mindboggling if the scale of the operation is so large that a single national committee is inappropriate. Can anybody imagine the volume of work that will be involved under section 7 of the Bill which says: "Where the Minister is satisfied that a proposed ethics committee for a clinical trial..." in other words, a committee for each trial. The Minister will have to be satisfied that there is an ethics committee for each individual trial. Unless I misread the Bill completely it means that ministerial approval will be needed for an ethics committee for each individual trial. I am not worried about bureaucratic bungling per se. There is no law in this world which says that because there is a State structure it has to be slow and inefficient or anything like that. That is a consequence of poor management; it is not a consequence of the structure. If one has a worry that a national ethics committee, expert in developing their own expertise with their own secretariat etc., will be somewhat slow-moving, can anybody imagine what it will be like when each individual trial — not each individual clinic — will have to have a separate ethics committee approved by the Minister? That is not my concern. I leave that concern to those who worry about large structures.
What I am concerned about is that it should not depend on the individual consciences of individual members of a committee that the public should be satisfied. It should be the way we set up the structures that renders bodies accountable. Individual accountability is a poor substitute for legal accountability. The real way for legal accountability is to set up a national ethics committee independent of all these bodies, nominated through the people by the Minister responsible for this area and which can quite competently do the necessary work. If we can have a bureaucratic system which assesses the competence of each ethical committee for each individual trial — not for each individual clinic — then it is perfectly feasible to set up a national ethics committee to deal with each individual trial and will probably deal with them far more efficiently than having to give approval for an ethics committee for each individual trial.
Therefore, I do not understand why this amendment cannot be discussed in terms of the value I attribute to it which is the value of independence, the value that it is not nominated by anybody doing a trial but is nominated by the person who is responsible for the welfare of the community at large in this area — the Minister.
I have come a little late into this debate. I would like to give a case from my own experience, an experience which in some way I regret in this instance. Some 20 years ago when I was avid to advance myself in the medical profession I decided that I had an interest in the study of abdominal pain in children and that I would pursue a line of clinical research. One of the things that had not been considered in the assessment of abdominal pain in very young children with regard to the possibility of duodenal ulcer developing was what is known as the pentagastrin stimulation test. If any of you has had that done as adults, you will know that it is a passage of a tube into the person's stomach, the injection of a chemical the purpose of which is to get the maximum stimulation of gastric juice and, over a period of two hours, to assess the amount of juice that is produced.
We studied some 100 or more children. In reasonably good faith I tried to explain to the parents what was involved. There is absolutely no doubt in my mind, looking back on it in retrospect, that the main purpose of this was my interest in whether or not there was excess gastric juice in these children with abdominal pains. The study was not very conclusive, but 100 young children had been put through a very nasty experience. I am quite certain if I had to select an ethics committee, or if the hospital in which I worked had had to select an ethics committee, it could reasonably have been argued that there was no danger to the child's life. Nevertheless it was an assault on the integrity of the individual. It required a great indepth assessment of the motive behind the research, the purpose of the research and the effect of the research on the people concerned, in this case children.
What would worry me very much about Senator Ryan's proposal is that I imagine the national ethics committee would perhaps be remote from the scene of action of research being done in Tralee, Waterford, Mallow or wherever. There is a tremendous volume of research being done today for the purposes of professional advancement as much as for the purposes of scientific advancement. I wonder if one ethics committee would eventually come to have very different thoughts from those which, as Senator Ryan quite rightly says, could evolve were the ethics committee more closely related to the institute or the person involved in the research process.
Therefore, I suggest that before this Bill becomes an Act this area needs further serious consideration. I wonder who would be prepared, who are scientifically orientated and who would spend the time required to look into all the research projects being advanced throughout the country in medical institutions and hospitals. How effectively could one committee do it and balance that against the dangers which Senator Ryan so rightly identified? There might be some case for having regional ethics committees.
I see some merit in the proposal made by Senator Ryan that there should be a national ethics committee but I still believe that it is not practical. On a national ethics committee one would not get the range of technical competence which an ethics committee would need to have if they were to deal with every conceivable trial that might be conducted in any year. In addition to the problems Senator Robb outlined which would obtain so far as a national ethics committee were concerned, this is a further problem. On a national ethics committee dealing with every application for every type of trial that might be conducted in a particular year, one would need to have represented every type of consultant, psychiatrist and so on. I see that as a problem in the setting up of a national ethics committee. The committee would have to be so large and unwieldy that the suggestion is not practical.
The two criteria which an ethics committee should meet are: first, they should be seen to be independent and, secondly, they should be seen to have the technical competence to deal with any application that might come before them. I would like to pose a question to the Minister: does he feel that the public would see an ethics committee nominated by the person who proposes to arrange for the conducting of the clinical trial as being independent? The public would be much more inclined to regard an ethics committee as independent if they were set up by some agency other than the person conducting the clinical trial.
I want to pose an additional question to the Minister. Does he see a role for respected lay people on ethical committees in addition to the scientific and medical expertise which has been referred to? I would like to see that type of role because it could bring an added dimension and sensitivity to the functions of the ethics committee. I am also disappointed that there is no specific reference to the presence of both male and female members of ethical committees, although I am not in any doubt as to the Minister's own commitment in wishing to see——
An Leas-Chathaoirleach
Much of this will come under section 7, I understand there is confusion because of all the amendments and I am sorry for interrupting you.
It certainly is confusing but since we were having a protracted discussion on ethics committees I thought I would add it in before the Minister replies.
An Leas-Chathaoirleach
This is the nice thing about this House — everybody is allowed to roam around.
Liberal latitude.
I would be particularly concerned about the points raised by Senator Robb and he may be assured that the NDAB and the Minister will look very closely at any trial involving children. In the first instance it would not be possible to carry out such trials unless they were in a particular condition requiring the trial. Indeed the Senator would concur that the criteria would have to be well established. I share the view of Senator Bulbulia that there should be a — I do not particularly like the word lay — consumer and women representation on such committees.
Going back to the nub of the amendment it would be almost impossible to have a national committee sitting permanently supervising the several hundred trials which are in operation simultaneously. They would have their own committees. Some may act for particular blocks of drugs or procedures but in all cases they would be subject to approval. It is important that they would be different from the existing ones which are ad hoc and unsupervised. On that basis I think the Senator will see the wisdom of this. Perhaps it is a sign of old age but I am beginning to get very chary about another national committee for another national problem. We are better off dealing with it within the framework as proposed in the Bill.
The Minister did not reply to Senator Bulbulia's question in relation to how the public would regard ethics committees which were in the first place nominated by the person conducting the trial. Does he think the public would see them as independent? I am also interested in how the Minister proposes to deal with what he now believes to be several hundred clinical trials. How does he propose to deal expeditiously with assessing the suitability of the ethics committee for each one of those trials which is what the Bill currently proposes he should do? If being expeditious is the issue, how is he going to deal expeditiously with assessing the appropriateness of the ethics committee for several hundred clinical trials each year?
In part, Senator Ryan has stolen the word I wanted to emphasise. Senator Mullooly made a very important point when he emphasised independence. The Minister says at his years he is beginning to get worried about another national committee. I am quite certain that the word "independence" is not escaping his attention. The essence of this is to be found in the independence of whatever committee structure and the representation of the consumer on it, as Senator Bulbulia said. The Minister confirmed that he will be paying great attention to a broad spectrum representation of the consumer.
Senator Mullooly asked the question about independence. I made a mistake. I am sorry.
Despite all the structures, ethics committees and so on we have or propose to have, has the Minister available to him the personnel or the structures whereby he can ascertain whether unauthorised clinical trials are being carried out within the country? As Senator Ryan said earlier, because we are in a situation of high powered commercialisation, particularly among the pharmaceutical industry, one would often get the impression that there are in progress in certain quarters unauthorised trials for which there is no medical supervision or ministerial approval within the Department. Does the Minister envisage that he will have in force some investigational structures he can implement at any time, or put into use at any time, to investigate if there are unauthorised trials in progress?
I can assure Senators that under the Bill the Minister of the day would have to be satisfied about the independence of the committees. Judgment inevitably comes in here, on top of the requirement that the committees be constituted in accordance with the guidelines. There will be administrative guidelines issued by the Department on the constitution of these committees. In addition, the Minister will have the advice and guidance of the National Drugs Advisory Board, which will have to be satisfied that the ethics committee is constituted in a balanced and impartial way. Should it emerge in any instance that there is a trial in train without a committee, that will be a statutory offence, effectively, under the Act. On that basis the Bill is reasonably framed. I concede that there will be several hundred trials on over a period but it is best that they be done within the block basis, or within the nominated basis.
To set up a national body would be to set up a parallel body to the NDAB and inevitably you would have the double-barrelled bureaucracy where the NDAB would be in conflict with the national ethics committee or the national drugs ethics committee. It does not stop the NDAB setting up their own committee to deal with ethical trials. They can do so as part of the functions of the board. The surveillance methodology of those committees can be assessed by the NDAB as part of their substructure. It is best to do it that way. It would be very difficult to take on board the Senator's proposal because, apart from anything else, we would have to have a new subsection dealing with what would constitute a national ethics committee. We could spend six months arguing the toss about the composition of it and the setting up of another body.
The question of independence has raised its head again. Senator Bulbulia, obviously rightly, expressed some concern about lay people as distinct from medical people in the composition of these boards. They are freely available. For example, in the ICP in Dublin they have — and it is right that they should have — medical people on the board because protocols are phrased in medical terminoly and it is important that there should be medical people on the board. It is interesting to refer to two people on the ICP board and what happened in the case of a former Labour councillor — I think he was a former Lord Mayor, Mr. Dunne — and Deputy Ben Briscoe. They were originally proposed from the local Eastern Health Board committee by Deputy Tomás Mac Giolla to act as their representatives. The Eastern Health Board did not accept them but the ICP people said: "They are acceptable to us. They were nominated and we will take them." They are on the board as independent minded people who will do their own thing and will not be influenced. They will not have any connection or be seen to have any connection with the ICP people. In Athlone in Elan, we have a World Health Organisation retired nurse, a priest, a local Garda sergeant, one of the medical people is a lady doctor and there are females on the various boards.
The suggestion of a national ethics committee who would look at every protocol, is not feasible. I feel very strongly that it would not be feasible or practical. I suggested a kind of national supervisory committee. Let it be part of the functions of the National Drugs Advisory Board. I would not disagree with that. They have clearly spelled out what they would like to see in regard to ethics committees. They have indicated that the following should be regarded as the minimum: three medical practitioners, a paramedical, one professional non-medical person actively and responsibly involved in administration or business, one person with legal training, one member of the lay public concerned with people and not holding polarised opinions on biochemical matters. They have set guidelines. There is an over-emphasis on the fact that people on these boards will be somewhat swayed by the companies that set up the ethics committee. I do not think that is possible. People on any of these boards who would be swayed in that way, should resign. I think that is what they would do.
I propose to withdraw amendments Nos. 4 and 21 with the permission of the House but in withdrawing them I want to make a couple of things clear. I want to make one thing clear, and that is, whatever the good intentions of the existing membership of ethics committees, particularly the ICP, I am satisfied that they failed to do their job. People were exploited in these clinics. There is and continues to be a disproportionate representation of unemployed and underprivileged people in the trials of these clinics. The procedure by which they recruited people for participation in these clinics was highly unethical in my opinion and the attractiveness of these clinics as a source of money to people who had no other source of money was in my view highly unethical. So whatever one may think about ethics committees and their independence and the good intentions of the membership, the truth is that they failed in their primary job in many cases of preventing exploitation.
I am not saying that nasty people set out to exploit people. I am saying that the shortest distance and the easiest route to get volunteers was used in many cases and, in that process, people were exploited and people did suffer. I regret very deeply — and I accept some of the arguments about a national ethics committee — that we are going to leave the nomination of these committees, in particular in the two major commercial clinics, to people who have not managed to protect people from exploitation in the past. That is a major part of the function of an ethics committee. I have heard nothing from the Minister so far about how the new ethics committees will avoid the errors and mistakes and omissions of the existing ethics committees.
In the interests of myself and Senator Robb I hope an alternative form of this amendment will be drafted which will meet the major objective of independence and perhaps by-pass some of the alleged bureaucratic problems. I propose with the House's permission to withdraw the amendment.
Amendment agreed to.
Amendments Nos. 4 and 5 not moved.
A number of subsequent happenings, including some information that I was not aware of at the time, prevail upon me to withdraw amendment No. 6 with the House's permission.
Amendment No. 6 not moved.
Government amendment No. 7:
In page 4, between lines 29 and 30, to insert the following:
"(3) An application under this section may be made at any time after the passing of this Act, but any application made before the day appointed by the Minister under section 18 (2) shall, for the purpose of subsection (1), be treated as if it had been made on that day.".
The purpose of the new subsection (3) is to provide that applicants do not have to wait until the commencement of the Act to make their applications. At the same time, it ensures that the statutory time limit for consideration by the Minister of the application obtains.
Amendment agreed to.
Section 2, as amended, agreed to.
NEW SECTION.
Government amendment No. 8:
In page 4, before section 3, to insert a new section as follows:
4.— (1) Where in relation to a proposal to arrange for the conducting of a clinical trial—
(a) an application has been made in accordance with section 3 (1), and
(b) any request made under section 3 (2) has been complied with,
then, the Minister, after consultation with the National Drugs Advisory Board, shall, not later than 12 weeks after the application has been so made or such request has been so complied with (whichever is the later) —
(i) grant permision for the proposed clinical trial to be undertaken in accordance with the application, or
(ii) grant permission for the proposed clinical trial to be undertaken in accordance with the application subject to such modifications or conditions as he may specify, or
(iii) refuse to grant permision for the proposed clinical trial to be undertaken.
(2) (a) Where under subsection (1) the Minister grants permission for a proposed clinical trial to be undertaken (with or without modifications or conditions), then the trial shall not be conducted until the ethics committee for the trial has given its approval in accordance with section 7 (2).
(b) Where under subsection (1) the Minister refuses to grant permission for the proposed clinical trial to be undertaken, then the Minister shall, when so refusing, inform the applicant of the grounds for such refusal.".
I move the amendment No. 1 to amendment No. 8:
To add to subsection (2) (b) "An applicant may appeal with evidence in writing within one month of the refusal and the National Drugs Advisory Board shall respond within 6 weeks."
Amendment No. 8 has already been discussed with amendment No. 1.
I was involved earlier in one amendment and I did not realise this amendment to an amendment was also being taken simultaneously. As the Cathaoirleach will appreciate, there has been a great deal of confusion, not through his fault, I might add, but because of the fact that we have pages of ministerial amendments and amendments to those amendments. We have been trying to get through them this afternoon and we are now giving time to the Minister of State to catch up with where we all are. I would like to deal with the amendment to amendment No. 8 with your permission.
I already called on you to speak on your amendment.
I spoke in relation to another item. I was not asked whether or not this particular amendment to the amendment was withdrawn.
We will be in a worse situation because as we take every amendment which has already been discussed, we will have to go over the ground again.
At the same time we have an unusual situation here. We have a Bill which is being so drastically amended by the Minister that it is a totally different Bill. Now we have a series of amendments coming up validly from three Members of the House. No doubt the three members are representing another 33 Members. There is a volume of reason for putting these down. It is very complicated to know where we are a lot of the time.
I might help you here. If you are not happy with the decision on it, we will accept the amendment for Report Stage.
That is perfect. I ask the Minister to consider seriously this amendment to an amendment which deals with appeals. There is a need to have some appelate arrangement in the Bill.
I called on you especially for that amendment.
When you called on me I thought it was in relation to the other amendment to section 2 of the Bill and I did not deal with it. I did not expect to have to deal with it at the time. As the Cathaoirleach has suggested, I agree that this matter can be dealt with on Report Stage.
I accept that.
In an effort to be helpful and throw a little bit more confusion on it, are we discussing section 3 as amended?
We are discussing amendment No. 8 to section 3 and as it has already been discussed, I am clearing it. It has already been discussed with amendment No. 1.
Yes, but of course it has been discussed and agreed that a new section 3 will be inserted in the Bill. Are we now entitled to discuss the new section 3? Obviously Senator FitzGerald is not in a position to move the amendment until Report Stage. Can he discuss the substance of the amendment during the discussion which now must ensue on the new section 3?
We discussed it with amendment No. 1. I called especially on Senator FitzGerald to speak on that amendment.
Are you suggesting that there is a section 3 in the Bill which will not be discussed?
It was discussed with amendment No. 1. The best I can do to accommodate Senator FitzGerald is to take it on Report Stage.
On a point of order, is it not true that we discuss Bills on Committee Stage section by section?
Quite true.
Now there is a new section 3 in this as a result of a decision taken earlier.
The new section 3 was one of the amendments.
The last section we dealt with was section 2. There is now a section 3 in the Bill. Do we now discuss this new section 3?
No, it was already discussed with amendment No. 1.
In other words, section 3 was disposed of before section 2.
I left at that time but in my opinion it was being discussed when I was leaving.
As I understand the position it is our responsibility to consider the section in their consecutive numbers. We cannot discuss section 27 and then go back and discuss section 5. I understand the point will be made that the new section 3 has been discussed, but the new section 3 has been discussed but cannot be disposed of before section 2 because, if we do that we are considering and disposing finally of section 3 before we consider and dispose of section 2. Notwithstanding the fact that section 3 has been included it is now a section which merits its own consideration. That is the point I am making.
The only decision we have to make now is what do we do with amendment No. 8? Do we accept it or do we reject it?
Are we talking about the amendment to amendment No. 8? I would like to make it clear that I got to my feet on section 1 after Senator Fallon spoke and I wished to contribute in a general way to that section and you said I was out of order so I sat down. Later on in the discussion I was prepared to get up and speak and you called on me but you did not call on me in relation to the amendment to amendment No. 8. You called on me in relation to the general situation.
I called on you.
In fact — if I could make my position clear — I thought at the time that my earlier amendment which fitted in at the end of section 1, which has now been drafted in the amendments for the Department of Health in section 2, would have been dealt with then and for that reason I declined to speak. I was not asked to speak in relation to the amendment to amendment No. 8. I spoke at some length on the other amendment I had down to section 2 which we dealt with earlier on. There was agreement that on amendment No. 1 we would also deal with amendments Nos. 5, 8 and the amendment to amendment No. 8 and amendments Nos. 9, 11, 12, 22 and a series of other numbers which were related to amendment No. 9. It is slightly confusing for Members, and at the very least, a Chathaoirligh, you might weigh heavily on the Clerk of the House to allow us to have some little freedom in dealing with this matter which is being treated in a much more severe manner than is appropriate in the circumstances.
The Clerk does not and cannot restrict debate but he is entitled to advise me. I am quite clear that I called on Senator FitzGerald to discuss the amendment to amendment No. 2 before I left the House. Senator Fallon spoke and I said: "Senator Alexis FitzGerald has this amendment", and I called on you. Maybe you misunderstood me.
I did speak to amendment No. 2. We are talking about the amendment to amendment No. 8.
But it is amalgamated with amendment No. 2.
The position is that the matter is down on the Order Paper and it has not been discussed and it is appropriate that we discuss it.
I cannot——
Earlier I had accepted the idea that it might come up on Report Stage. Since I have been listening to other contributions from my colleagues it seems to me that some method might be found, if not now later on this evening with the approval of the Minister, to deal with it rather than leaving it until Report Stage when the Bill is moving to its final descent into the grave. It is virtually completed as far as this House is concerned.
Three or four times already you mentioned the complication of the Bill and the number of amendments. This is what we are at now. I asked Senators to be very careful about this, and I went through the list of amendments that were being discussed with amendment No. 1 on three or four occasions. I called on you with the intention that you would take that amendment and the other amendment at the same time.
You will accept that I misunderstood you and I took another amendment.
I do not blame you for misunderstanding me. I will not go back to amendments which have been discussed after this. I want everybody to be clear.
We are dealing in section 3 with the conduct of a clinical trial. It reads:
the Minister shall, as soon as practicable —
(i) grant permission for the proposed clinical trial to be undertaken in accordance with the application, or
(ii) grant permission for the proposed clinical trial to be undertaken in accordance with the application subject to such modifications or conditions as he may specify, or
(iii) refuse to grant permission for the proposed clinical trial to be undertaken.
I am talking about the normal request included in so much legislation. If you go for a planning permission to your planning authority and are refused, depending on which side of the fence you are on, and as the third party you feel aggrieved by the decision, there is an opportunity to go to a body called An Bord Pleanála. I heard it suggested on this amendment that we should allow for the fact that there will be aggrieved parties to decisions taken by the Minister on advice from the National Drugs Advisory Board. I have suggested that within one month evidence in writing must be furnished to the Minister and the National Drugs Advisory Board shall respond within six weeks. We should have some system of giving a second bite at the cherry, a second possible way of permitting a trial to take place and with a provision to tease it out through the appeal process to be provided in the Bill. It could be very helpful for the evidence in writing to include an explanation of the difficulties the NDAB had in advising the Minister to consent to the trial in the first place. The process of having a system of appeals in this Bill would be very helpful in the future. I suggest this amendment should be treated seriously and accepted by the Minister.
I support the view of Senator FitzGerald. The Minister has come a long way in this section. He has a similar amendment which indicates that the reason for the refusal should be given to the person or persons carrying out the trial. That is going some of the way. I support the view that there ought to be an appeal procedure and the appropriate body for such an appeal would be the National Drugs Advisory Board who are the experts in this area. It is a very reasonable suggestion and it is one I have no hesitation in supporting.
I would also like to support some of the points made by Senator FitzGerald. On Second Stage I made the point that in the section, as drafted, there was no obligation on the Minister to outline the reasons for a refusal to grant permission for any clinical trial. I also made the point that there was no provision in the section for an appeal against the decision of the Minister. The Minister has met my first point in the new section as drafted and the amendments submitted by Senator FitzGerald would meet the second point I made on Second Stage.
I am not blaming the Senator, I am blaming myself for bad judgment.
I approve of your bad judgment. I support Senator FitzGerald because written into the Bill there is no court of appeal and I see that as something of a weakness. Section 3 empowers the Minister to apply whatever conditions he considers necessary for the safe conduct of the trial. It appears that, even if a study has been approved by an appropriately constituted ethics committee, the Minister has the authority to turn down such a study or revoke permission at any time. In section 6 it is stated that he can do this for any other reason. There is no court of appeal which is part and parcel of this Bill and no requirement on the Minister to justify or explain any decisions like that. It is extreme, if not autocratic, and I would like further clarification of this from the Minister when he replies.
A Chathaoirligh, I appreciate that we are, in fact, in injury time so I too will be brief in my submissions. I support those Senators who have agreed with the principle of providing for a form of appeal and I would like the Minister, in responding to the debate on this proposed amendment, to outline what is the recourse that can be taken if the application is refused. The Minister is required to give reasons for the refusal. That normally infers that there is to be some other consideration of it at a different level. That would be a standard provision where there was going to be some mechanism for appeal. When I was speaking on Second Stage I referred to the Scandinavian institution of a national clinical advisory body.
What is proposed in these amendments is that the National Drugs Advisory Board would be a form of appeal body, but what I want the Minister to tell the House is what would happen if the application is refused. Is that the end of it as far as the applicant is concerned? How is the applicant, in effect, to move on from there? It does seem an unusual situation that, whereas the Minister can attach conditions or must give reasons for refusal, no other mind will address the issue and there is no other possibility for the applicant, in pursuing the matter, to take it further. We need to have some explanation of that. On both sides of the House there is general agreement that the House would prefer if there were some mechanism for appeal. Perhaps we could come back to that on Report Stage.
I would like to ask the Minister if he is prepared, in responding to the discussion about this amendment and the amendment to the amendment, to address himself in particular to academic trials as opposed to industrial trials — perhaps I should say to both — on the whole purpose of these trials? What is the priority of purpose — I was going to use the word "motive" but I thought that would be judgmental — because it has been my impression as a member of the medical profession and having been an academic in that profession that it is high time we addressed ourselves to the quantity of research being done in relation to the purpose behind it?
While there is no doubt that it is very important to undertake trials in order to test the efficacy of drugs which one hopes will be of benefit, at the same time it has been my opinion — I think this is shared, although often sotto voce, with other members of the profession who are concerned that in recent years under the pressure of the publish or perish mentality, under the pressure of multiple “diplomatosis”, a disease that affects our profession in order to advance oneself — that a lot of research is being done where the prime purpose is the advancement of the person doing the research often through no fault of his own. I would go further and say usually through no fault of his own but through the present philosophy of higher institutional professional imperialism which dictates that, regardless of the clinical job into which the trainee will eventually be slotted he must do research which will further advance the institution in which he is being trained and will also further support —“support” may not be the correct word — the whole academic framework in which professionalism and institutionalism go hand in hand.
I would like the Minister to address himself to that when he is considering section 3 so that those who are judging whether permission should be granted, should take on board a very serious aspect of the whole dilemma of modern research, whether it is being done in order to push forward scientific frontiers, or whether it is being done in order to push forward careers.
I have two brief comments. I have no objection to the intention that Senator Alexis Fitzgerald has in mind, but I cannot see that it will make any difference if an applicant may appeal to the National Drugs Advisory Board because all the NDAB can say is they do not agree with the Minister. It would still be a matter for the Minister to decide. The National Drugs Advisory Board are not the deciding body in this matter; it is the Minister. Therefore, an appeal might — if I can mention vanity again — heal the wounded vanity of the applicant but it will not make any difference to the permission refused. They will still be stuck with the refusal.
Senator Robb touched on something that is of fundamental importance and which underlines the need to ensure that the controls of these areas are outside the profession and are accountable to society at large. One would have the impression — this is not exclusive to medicine but it happens to be medicine we are talking about — that research is something that is naturally directed to the areas of greatest human need, irrespective of any other consideration.
The truth is that it is often the exact opposite. It is often that research is directed in the area of maximum human demand in terms of cash, resources, the society which can afford to pay for them. A huge volume of research is devoted, for instance, to things like coronary heart disease and cancer which are largely diseases of degeneration resulting from excessive indulgence in the good things of the affluent society while very little is devoted to the cheap mass production of basic drugs needed by two thirds of humanity who cannot afford to pay for anything. If we are talking about medical research based on need, the huge proportion of medical research ought to be based on the mass production of the basic drugs needed to eliminate the basic ailments that afflict large sections of humanity, particularly the elimination of mass infant mortality which could be done quite effectively. There are various things one could talk about here, but there is no evidence at all that medical research is based on human need and a considerable amount of evidence that it is based on crude consumer demand. In that case ethics are very important and accountability to society is extremely important.
Now that we have finally determined that we are addressing an amendment to amendment No. 8 I will try at short notice to unravel some of the problems which have beset Senators all day. The Minister does not consider this amendment necessary. In practice it will be open to the applicant who has been refused a permission to discuss with the NDAB the reasons for refusal and the steps that might be taken to revise the application. I think that should answer Senator Robinson's question. There is at the moment, where medicines are being licensed, a means by which any applicant who runs the risk of not having his product approved by the NDAB can go and discuss it with the staff of the NDAB and that will still be open to anybody in this particular case. I sincerely hope that will go some way towards alleviating the problems.
This is what happens at the moment in relation to the licensing of medicines and it is a system which has worked very well without the need for any specific legislative provisions for appeals. The Minister, on the best advice available to him, has said there is no need for any legislation in that regard to allow the appeals procedure to go on as before. Senator Robb made a point about superfluous medical research and it is well made and taken. It would be the intention to question the real need for the trial in each instance but, of course, basically we rely on the professional standards of the people in the medical profession to ensure that they are upheld and that they monitor their peers, especially young and ambitious doctors.
Amendment No. 1 to the amendment No. 8, by leave, withdrawn.
Amendment No. 8 agreed to.
We have already discussed amendments Nos. 9, 10, 11 and 12. That disposes of the section.
SECTION 3.
Amendments Nos. 9 to 12, inclusive, not moved.
Section 3, agreed to.
NEW SECTION.
Amendment to amendment No. 13 and No. 13 are related and may be discussed together.
Government amendment No. 13:
13. In page 5, before section 4, to insert a new section as follows:
5.—(1) Where, in relation to a subsisting permission granted by the Minister under section 4 (whether or not previously amended by virtue of this section), it is proposed to do, or refrain from doing, any act in relation to the proposed clinical trial or the clinical trial (as the case may be) otherwise than in accordance with the permission, the the person who applied for the permission shall apply to the Minister for an amendment thereof and the Minister may, after consultation with the National Drugs Advisory Board, agree to the amendment of the permission.
(2) Where under subsection (1) the Minister agrees to an amendment, it shall not be acted upon until —
(a) in the case of a proposed clinical trial, the ethics committee for the proposed trial has given its approval to the proposed trial (as so amended) in accordance with section 7(2).
(b) in the case of a clinical trial which has been approved by the ethics committee to which it relates, that ethics committee has given its approval to the amendment.
I move the amendment No. 1 to amendment No. 13.
In subsection (1), after "Minister may" to insert "shall respond within three weeks."
This new section would replace section 4 of the Bill as published. It introduces two changes to the old section 4. It provides for a specific reference to the role of the NDAB in considering applications for amendment of permissions. The new subsection (2) is consistent with the removal of the overlap between the functions of the Minister and those of the ethics committee which was dealt with in amendment No. 8.
This is amendment to amendment No. 13.
That is right.
It is provided here that "the person applied for the permission shall apply to the Minister for an amendment thereof and the Minister may, after consultation with the National Drugs Advisory Board, agree to the amendment of the permission". What I am asking here is to insert "shall respond within three weeks" to have some reasonable period of time during which consideration of the case goes on, and that we do not have an unlimited period given to the Minister to respond as outlined in this section.
I would like to support the idea of having some time limit on the consideration by the Minister of an application here for amendment in effect in relation to a proposed clinical trial. That is what will be achieved by this. It seems to me that it requires that the person seeking the amendment should know there would be some cut-off period. Senator FitzGerald has proposed three weeks. That seems to me to be reasonable. Even a six week period would probably be the outside of what would be considered reasonable. The whole question of time limits is very important here because it will affect how these applications are processed. In section 8 there would be what I think is a very long period of 12 weeks for the original application and then no time limit in relation to the question of amendment. This is a matter which could lead to getting bogged down while awaiting the outcome of the consideration. I hope the Minister will respond favourably to the idea of a time limit.
I have amendment No. 17 down here. Do I take it that amendment No. 17 automatically lapses if the Minister's amendment is accepted? I presume it does since it is an amendment to the existing section which will have been deleted.
I think you are right. Amendment No. 17 cannot be moved.
May I respectfully request that it be discussed along with the current batch of amendments as it is related to them?
I see nothing wrong with that.
I am grateful. Unless we have an earthquake in the next five minutes it is extremely unlikely that the Minister's amendment will not be carried. I thought it was reasonable, therefore, that I should ask that permission.
They had a tremor in North Wales.
I agree with Senator FitzGerald's amendment and I think the Minister's amendment elaborates on section 4. Section 4 has to do with where a person with permission wants to amend the clinical trial and the procedures that must be adopted to do that. The Minister has elaborated on the procedure that must be gone through before permission can be given to amend that trial. What disturbs me is that there is no clear provision now that the individual undergoing the trial or participating in the trial shall be informed with the same detail and the same conscientiousness about the nature of the amendment to the trial as he or she was informed when they began the trial before it was amended.
Amendment No. 17, simply said, "provided that he is satisfied that the provisions of section 8... have been complied with". These have to do with the participants in the clinical trial and have all to do with ensuring that the person participating knows what he or she is doing, knows the risks and is properly informed and freely consents. All of that is contained in section 8 and all of that is built into section 8 because, quite rightly, it is recognised that it is extremely important. As the Minister's amendment is stated there is no requirement to comply with section 8 where it is proposed to amend the trial. That would be fine if we were talking about minor amendments only, but there is nothing in here to suggest the scale of the amendments, so we are effectively depending upon the judgment of the Minister and nobody else as to whether trials can or cannot be amended. The poor misfortunate individual who has volunteered to participate in a trial could well have the trial changed and not be consulted at all about it as the current phraseology stands.
The simple reference in the Minister's amendment is "until ... the ethics committee for the proposed trial has given its approval to the proposed trial (as so amended) in accordance with section 7 (2)". The reference to section 7 (2) intrigues me because section 7 in its entirety covers all the duties an ethics committee must fulfil. It lists in subsection (4) a series of undertakings which an ethics committee must fulfil in order to meet their responsibilities. But it is not section 7 that is referred to in the ministerial amendment, it is section 7 (2) thereby excluding most of the duties of the ethics committee which should properly be carried out in the case of an amendment to the trial. It was very simple to meet my concerns. It would simply mean amending the Minister's amendment so that it referred to "in accordance with section 7". In other words, if the ethics committee had to do everything provided under section 7 in the case of an amended trial it would meet all my concerns because that would necessitate their being satisfied about the degree of consent of the individual, the degree to which the individual participating in the trial was informed.
Without that, the poor misfortunate who is at the centre of the trial, the participant, may well not be properly informed about what is being done to him, what is being amended about what is being done to him, and the possible risks to himself resulting from that. Therefore, since as I said, it is unlikely that there will be an earthquake and the amendment will not be carried, I request an elaboration from the Minister or the Minister of State or whoever wishes to elaborate on it as to why this reference in subsection (2) of the Minister's amendment is only to section 7 (2) and not to the entirety of section 7 which would appear to me to be the logical way to do it if we are concerned about protecting the participants in these trials.
I would like to support the amendment to the amendment proposed by Senator FitzGerald and also the point which Senator Brendan Ryan has just made. The time limit is of vital importance. Taking into account all I have said about the dangers of the research model, and the purpose of it, there could be nothing more frustrating than to be doing research in the form of a clinical trial and to want to change the emphasis and then to find that the whole procedure became bogged down in interminable bureaucratic-type delay. That has to be supported, whether or not it is to be three weeks, and this is asking rather a lot, particularly if there is to be a national as opposed to a regional or further subdivisional ethics committee. It needs to be specified and it needs to be a short rather than a long time.
From the point of view of clearing up whether the person understands what is being carried out, there is a simple device. After all, we are now said to be more extensively educated than ever before and I cannot see why the Minister could not encourage the presentation to the ethics committee of a simple statement either on tape or in writing of not more than 150 words by the person on whom the trial or the altered trial is being conducted of what they understand is being done to them. It would then be quite clear that there had been communication. They would have a perfect right to say what they understood was being done to them and this would be presented in their own words and in their own way and the ethics committee could judge accordingly.
I support the proposed amendment by Senator FitzGerald. It is reasonable that there should be a time limit on it.
May I ask the Minister whether, if this time limit is accepted, and whether it is three weeks or six weeks, as a consequence of failure to comply with it, the whole application would lapse or would the application be granted automatically without permission within the statutory time allocated? I should like to know which would be the case: whether the original application would lapse or the Minister would have to grant it automatically as is the case in certain other instances.
When I spoke earlier I was not aware, or at least it was not the case, that we were also considering amendment No. 17 which we now are.
I support the reasoning behind this amendment as explained by Senator Ryan. We must be concerned to ensure that where there is the process of applying to amend, that process will necessarily involve that any persons who may already be actively taking part in a clinical trial — it may be changed after it has been set in motion — would be informed for the purposes of securing a consent on their part to the proposed clinical trial as amended. It may be that the ethics committee would necessarily ensure that, but I share some of the reservations expressed by Senator Ryan about the way in which the present amendment is drafted in subsection (2) (a) of section 5. The important issue that must be ensured before the amendment is accepted is that any person who would be going to take part in the future, or who would be in the process of taking part in a clinical trial, would be made aware of the scope of any proposed amendment and would express his or her consent to that.
I support the idea of time limits which are of vital importance to the success of the clinical trials and the area of clinical trials generally. Delays can mean chaos and they can create real problems for companies engaged in this business.
If Senator Ryan is correct in what he is saying, he is perfectly right to raise the matter. Senator FitzGerald is proposing that, in the event of the National Drugs Advisory Board not allowing a particular trial to take place and if there is to be an appeal or an amendment in some form to it, the amendment should take place within three weeks. As I understand it, all of that work is done prior to its arrival in the clinical set and the trial and all matters pertaining to it, which have been cleared at that stage, are explained in detail, as they ought to be, to the participant. A trial should not change in midstream at any time. If it does, obviously the participant should be fully informed of the change. This is not what Senator FitzGerald has in mind. He is talking about where the trial was finally agreed upon and then brought to the clinical trial where the participants are brought in and you advise them in great detail of what is happening. It stops at that stage.
In reply to Senator FitzGerald's amendment to Amendment No. 13, the Minister accepts the logic of providing for a time limit for an amendment since there is to be a time limit on the permissions consideration. He has agreed to come back with an amendment on Report Stage and incorporate a time limit similar to that for a permission. I thought I was coming to grips with this until Senator Ryan entered the fray and complicated things further. I must confess it is complex.
The Minister does not consider that the amendment No. 17 is appropriate. Section 7 (4) (d) requires the ethics committee to have regard to the procedures proposed for compliance with section 8 before they give their approval for a proposed clinical trial. This is because these consent requirements give rise to many considerations of detail. It remains the responsibility of the ethics committee to ensure that the consent of the participant is based on an understanding of the significance of any amendment to the proposal if this is relevant. While the Bill outlines the responsibilities of the ethics committee, it does not purport to be an exhaustive list of the markets it must have regard to. The nature of the ethics committee's responsibility can hardly be in doubt from the context in which it is referred to in the Bill. Such a detail as requiring the committee to ensure that the information to the participant is updated as necessary is further required.
I should like to make an appeal to the Minister in relation to this matter.
You had better report progress.
Progress reported; Committee to sit again.