Amendments Nos. 18 and 53 are related. Amendments Nos. 58 and 59 are consequential. Amendment No. 18, the amendment to amendment No. 18 and amendments Nos. 53, 58 and 59 may be discussed together.
NEW SECTION.
Control of Clinical Trials Bill, 1986: Committee Stage (Resumed).
Government amendment No. 18:
In page 5, before section 5, to insert a new section as follows:
6.—(1) A person shall not conduct a clinical trial unless—
(a) he is a registered medical practitioner or a registered dentist,
(b) there is a subsisting permission granted by the Minister under section 4* in respect of the trial, and
(c) the provisions of section 4 (2) (a)* or 5 (2) (a)*, as the case may be, have been complied with.
(2) In this section—
"conduct a clinical trial" means the conducting of a systematic investigation or series of investigations for the purpose of ascertaining the effects (including kinetic effects) of the administration of one or more substances or preparations on persons where such administration may have a pharmacological or harmful effect, but does not include the conducting of such a systematic investigation or series of investigations as aforesaid—
(a) where
(i) the administration of one or more substances or preparations, as the case may be, is on a patient in the ordinary course of a medical practice (in the case of a registered medical practitioner) or of a dental practice (in the case of a registered dentist) and
(ii) the principal purpose of that administration is the welfare of the patient,
or
(b) where the substance or preparation concerned is to be administered to persons undergoing a course of training leading to a qualification which will entitle such a person to be registered as a registered medical practitioner or as a registered dentist or as a registered pharmaceutical chemist and where it is to be administered as part of such a course of training, or
(c) for the purpose of examining the nutritional effect of the substance or preparation concerned where that substance or preparation is a normal dietary constituent;
"registered pharmaceutical chemist" means a person registered in the Register of Pharmaceutical Chemists for Ireland maintained under the Pharmacy Acts, 1875 to 1977.
I move amendment No. 1 to amendment No. 18:
In subsection (2) (b), after "chemist" to insert "or as a registered physiotherapist".
The reason for this amendment is that the new section will replace section 5 of the Bill as published. It introduces four changes in the old section 5. First, it provides that a permission or an amendment of a permission may not be availed of unless the ethics committee have given approval. I refer Senators, at this stage, to section 6 (1) (c). Secondly, the term "medical" has been objected to as being too vague. "Pharmacological has emerged as a more appropriate word but as it is not generally accepted as including the kinetics or metabolism of a substance in the living body, it is advised that "including kinetic effects" should also be included in the definition of "conduct a clinical trial."
This amendment makes it clear that the Bill, except where specific exemptions are provided, covers all clinical trials involving the administration of substances or preparations for the purpose of ascertaining the pharmacological effects, the pharmacokinetics, the bioavailability, toxic or harmful effects, tolerance, therapeutic effects, comparative effects and also preventive effects. The new wording of subsection (2) also includes the description "systematic" and this is considered to clarify that ordinary medical or dental practice is not caught within the ambit of the Bill. It has also been argued that it is not possible to say that any investigation or practice is "exclusively" for the welfare of the patient in question, so this has now been changed to read "the principal purpose".
There are two other points I would like to refer to. The section provides for an exemption from the provisions of the Bill of practical demonstrations of the effects of known drugs in medical, dental and pharmacological classrooms. Finally, it also provides for an exemption from the provisions of the Bill of nutritional studies involving normal dietary constituents. This is the replacement of section 5 of the Bill. In many ways it arises from representations made to me in the course of the debate following publication of the Bill and also from the observations of Senators on Second Stage on the Bill itself.
I should like to begin by supporting Senator FitzGerald's amendment to the Minister's proposed new section because I know there is, for example, a serious concern among a number of physiotherapists in Trinity College that they would now be excluded from conducting clinical trials with simple substances, substances for example, such as proprietary gels or powders or electrode pastes and that these, in fact, are not covered by the section as it stands and these would in effect amount to clinical trials and require what it is necessity to apply under the Bill. I ask the Minister when he is considering this amendment and considering the position of physiotherapists to also address the question of whether practical classes involving physiotherapy students which are required by them in order to obtain their existing qualifications will be allowed to be exempt also from the Bill. These are part of the training of a physiotherapist. Are they excluded from being within the scope of the Bill?
For these reasons I feel that there is merit in the amendment put forward by Senator FitzGerald. This is a concern shared widely by physiotherapists and they too would wish to be specifically referred to in order to exclude them from the application of the Bill in a manner which I do not think was in any way intended as part of the overall purpose of having protection for those participating in clinical trials.
There is another matter; it is simply a matter of seeking clarification. Like a number of other Senators I am puzzled by the bracketed clause "(including kinetic effects)" which is now expressly part of the Minister's proposed new section 5. As I understand the meaning of kinetics, basically it relates to movement of drugs in the body — in effect, a movement in time — and that kinetics relates to the information necessary to show how the body has handled a particular drug or drugs and, for example, how long a drug stays in the body. Therefore, it does not seem to me that it would be appropriate to refer to "(including kinetic effects)". It could be including the "kinetics of the substance." That is my limited understanding of the term. Perhaps the Minister would explain it more fully when he replies on the section.
Finally, I should like to say that the section does represent a very considerable response by the Minister to representations to him and to issues raised on Second Stage. I welcome the fact that the Minister has been prepared to make a very substantial amendment as represented in the new section. I hope he will accede to a further amendment of it either in precisely the form put forward by Senator FitzGerald or ensure that the very real concern and worry of physiotherapists are allayed in the manner which I have described.
I was in the dilemma when this amendment was called that I had just arrived in the Chamber. I observed Senator Mary Robinson as I came in and, knowing her particular interest on behalf of her Trinity constituents, I felt it appropriate that she would take up the matter, as she did, a moment or two later. It is worth making the point in relation to this amendment that we are talking here, as Senator Robinson has mentioned, of the concern of physiotherapists about the simple use of substances which are actually gels, powders and electrode pastes. In effect, what we are talking about is heat treatment physiotherapists apply in one form or another by way of clinical trials. Clinical trials have an important therapeutic effect on patients and even on those who are there for the purposes of the trial. It is a matter of concern to them that such a number of different areas are being categorised by the Minister in the section — which is very much welcomed — when he talks of the registered medical practitioner or the registered pharmaceutical chemist. It is apropriate in this area, with the considerable role the physiotherapist has now developed within the medical world and the hospital system, that they should be treated with the very same inclusions and recognitions this amendment seeks. I hope the Minister will accept this amendment or, if not, that he will come up with something suitable to deal with the point I have made.
Very briefly, I wish to support Senator FitzGerald's amendment in regard to the concern and worry that physiotherapists have. We can all agree that they have a role to play in trials — maybe not in the way that we imagine trials. Certainly the work physiotherapists are doing in health generally is extremely important particularly with the disabled and in the area of arthritis which we know is a painful and crippling disease. The work they can do in regard to treatment, wax treatment, or whatever work they think is necessary to further advance their concept of what might bring about a greater healing and soothing effect is important. For that reason I, too, support that amendment.
Regarding the physiotherapy proposal, the effect of Senator FitzGerald's amendment would be to provide an exemption from all of the provisions of the Bill for physiotherapy classroom demonstrations. That would be a particular exemption for what the Senator described as registered physiotherapists. I want to give the assurance that, after careful examination, physiotherapy training as such is not affected. Therefore, undergraduate training for physiotherapy is not affected by the Bill.
A situation can arise where in the physiotherapy training classroom a substance, for example, creams, could be administered. These would be used for demonstration purposes, not for trial purposes or for the purpose of ascertaining the effect of them in a trial situation. Therefore, the position where physiotherapy training demonstrations or medical training demonstrations are concerned is not necessarily of the kind to which reference is made in the Bill. In any event, if the physotherapists were using an unknown substance it should be done under medical supervision and would come into a trial situation.
Although I am sympathetic to the idea of registered physiotherapists, I will not go down that road. I am sorely tempted to talk about physiotherapy and the need for registration. We do not have a system of registration of physiotherapists here as yet. Therefore, I can assure the Senator that the fears the physiotherpists have do not arise under the Bill.
Senator Robinson referred to the kinetic effects. It has been difficult to reach a definition. We have had extensive consultation and protracted discussion with our legal and medical advisers and they are satisfied it covers all of the aspects involved in trials. As I indicated to Senators, it is a fairly broad definition. The industry and the professional staffs involved in trials accept it as a reasonable definition because it encompasses not only the pharmacological effects but also the pharmacokinetic effects and the bioavailability issue, the major issues of toxic effect, tolerance, therapeutic effects, comparative effects and finally, the one we are most concerned with, the preventive effects. These are covered in the Bill. Senator Robinson's points are somewhat different from those of Senator FitzGerald. He was concerned with teaching classes and I can assure him that ordinary physiotherapy work and practice is not affected by the Bill.
As I understand it — I may not have made this point as clear as I should have when making my first contribution to this amendment — the concern of physiotherapists at the moment is that they would, by the new section, be excluded from conducting clinical trials with some of these simple substances, gels, pastes or heat substances. That concerns them because they do it at the moment. They are being excluded from being in a position to do it as I understand it. What is the Minister's reason for that?
We did have correspondence — Senator FitzGerald alluded to the fact that the Senator may have had some consultations with her Trinity colleagues — with the head of the Trinity training school. My Department wrote to the head of the school some time ago confirming that the Bill did not affect physiotherapy practice, and did not affect demonstrations or trials provided — this was to be the caveat purpose of the Bill — the substance used was not an unknown one. In that framework it would come into the context of a trial. I think the head of the training school is satisfied with the explanation.
I accept the Minister's assurance in relation to the practical classes involving physiotherapy students, but it is not clear to me how physiotherapists can be included in the present provisions of the new section 5. They are, in fact, excluded by the way in which section 5 is couched. Therefore, they cannot carry out clinical trials with these simple substances, maybe I am misreading it: that seems to me to be the thrust of the section as it stands. I have not heard the Minister give a rationale for it. He has, by the effect of section 6 (c) as it stands, excluded the nutritional matters from the Bill. I do not think he has covered the point raised on this section and I would like to understand what the reason is for not including physiotherapists as being in a position to carry out these clinical trials unless there is some particular worry on his part.
I should like to go along the same road as Senator Robinson. I do not understand how the profession of physiotherapy will find itself situated in the immediate future in dealing with new substances that need to be tested, that need to have a clinical trial to establish their value from a therapeutic point of view. I wonder with the increasing significance of physiotherapy in the medical world, with the increased extensive longevity in the community and the recognition that physiotherapy is now getting, if we are finding a difficulty with the word "registered" simply because physiotherapists are not registered. I can see the Minister's point in that area. Is that the sole reason for not being prepared to accept the amendment in this area? I do not know if the Minister wants to comment at length on the registration of physiotherapists, it seemed he did not want to go down that road. It may be that by introducing the words "registered physiotherapists" in this Bill we might have more chance of dealing with the registration of physiotherapists in the foreseeable future than by leaving them out.
I am not clear on the position of the physiotherapists who want to deal with a new substance. The Minister said they were quite entitled to use a clinical trial for substances already established. If there is a new substance on the market which a drug company has developed and which might have an important therapeutic application, what is the position of a physiotherapist who is in touch with the drug company which is prepared to fund the trial for the substance, cream or whatever it may be, and which may be very useful to medical science or rather in the treatment of patients? Will we find a problem in allowing for a new substance to be introduced for the purposes of dentistry and medicine but not physiotherapy?
The reality is that physiotherapists as such cannot be covered under the Bill because, first of all, anybody in this country can call himself or herself a physiotherapist. There is no registered profession. Even if there was a registered profession, a trial can only be conducted under medical supervision. Therefore, to draw the analogy, if I decided to call myself a physiotherapist and decided to lessen the pain of the loss of a ministerial seat by using an unknown substance, I certainly would not be authorised to do so.
Is this for self-application?
Therefore the main concern of the schools of physiotherapy — those who have a recognised professional status but not a formal, statutorily registered status — is that a good deal of their work would be diminished. That would not be so. If they are going to become involved in trials relating to particular substances of a new formulation, they would have to accept medical supervision and medical authority. Medical responsibility would come into play in relation to the trials. We could not have a situation under the Bill where physiotherapists conduct a trial. It is not a blockage in the Bill. The Bill does not cover that eventuality. Where does one stop if one provides an exemption? We are not writing exemptions into the Bill; we are devolving responsibility on particular people for the conduct of trials. It would be a very considerable step to allow the conduct of clinical trials involving substances which may have a pharmacological or harmful effect to be used other than under medical supervision. I know quite a number of nurses who are quite expert as physiotherapists but they would not have authority to conduct a clinical trial.
Progress reported; Committee to sit again.