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Seanad Éireann debate -
Wednesday, 16 Dec 1987

Vol. 118 No. 1

Death of Former Members. - Control of Clinical Trials Bill, 1986 [Seanad Bill Amended by Dáil]: Report and Final Stages.

This is a Seanad Bill which has been amended by the Dáil. In accordance with Standing Order 82, it is deemed to have passed its First, Second and Third Stages in the Seanad and is placed on the Order Paper for Report Stage. On the question that the Bill be received for final consideration, the Minister may explain the purpose of the amendments made by the Dáil and this is looked upon as the report of the Dáil amendments to the Seanad. The only matter, therefore, that may be discussed is the amendments made by the Dáil. For the convenience of Senators I have arranged for the printing and circulation to them of those amendments.

Question proposed: "That the Bill be received for Final Consideration."

As Members are aware, they may speak only once on this question.

It gives me great pleasure to bring this important Bill back to this House. This complex and technical Bill was initiated in the Seanad where it was discussed at great length by Senators. As a result of the constructive contribution of Senators, 56 amendments were incorporated into the Bill and it is widely acknowledged that the in-depth debate in the Seanad greatly facilitated its passage through the Dáil.

The Bill, as it now stands, provides comprehensive safeguards and constitutes a solid framework for the control of clincial trials. A small number of amendments were made in the Dáil and I am sure Senators will agree that the nature of these amendments further underlines the dual goals of the Bill which are to provide an effective system of control over clinical trials to protect participants in such trials and, at the same time, to facilitate legitimate research.

During the course of the discussion on Committee Stage in the Dáil on the Bill the Minister undertook to re-examine section 2 as drafted. He referred to the need to bear in mind that the protection of the interests of participants in trials was of the utmost importance. To this end it was proposed in relation to trials specified in subsection (2) of section 2 to include an additional safeguard to the extent that the National Drugs Advisory Board had to satisfy themselves with the compostion of a committee appointed to consider the justification for the conducting the proposed clinical trial and the circumstances in which the trial is to be conducted. The committee would in effect, be an ethics committee but not one to which the statutory requirements for ethics committees specified in the Bill would apply. The need to build into the Bill a requirement that a third party would have a vetting role in relation to clinical trials using medical products which have a product authorisation has been mentioned by a number of competent organisations and persons on a number of occasions. The first amendment was, therefore, incorporated in the Bill to further strengthen section 2 (2).

In case of any confusion, Senator Robinson, it is usual, as I have explained already, that the amendments are all taken together because they are amendments back to us from the Dáil.

Subject to your clarification of the point, I understood that we were on Report Stage and that it would be possible to make a contribution on each of the amendments. Is that correct?

The amendments are not before us. They were made and they are only back for total clearance by us.

But this House technically could refuse to accept them and then delay the Bill. Is that not right? I am not suggesting that will happen but it could.

It is not the normal Report Stage. I am sure what you are saying will not happen.

It is a complex Bill. I do not think this will take long. It would certainly be simpler to take each amendment and make a brief contribution on it. I accept totally the objective of this amendment as inserted in the Dáil. I simply wanted to ask the Minister how the National Drugs Advisory Board would be expected to satisfy themselves in relation to the composition of the committee. What would be the criteria that would be applied by the National Drugs Advisory Board? Presumably the type of person who sat on this committee would be the normal type of person on an ethics committee. I am just concerned to know the scope of the power because it is rather generally phrased and, as the Minister said, it is a third party satisfying itself on the composition of a committee. It would be helpful if there were some indication of what the criteria would be for being satisfied about the composition of the committee.

The Department will be preparing guidelines for the National Drugs Advisory Board in connection with the composition of the ethics committees and may I remind the Seanad that, in fact, 56 amendments were actually accepted by the Seanad. I would like to compliment the Seanad. This shows the justification for having technical business of this nature debated by this House because of the number of amendments that came from here. It meant that the passage of the Bill through the Dáil was far more speedy than it would be normally. The amendments coming back are very small amendments to the Bill. They do not change it that much.

I wish to support the amendments passed by the Dáil. As the Minister has rightly said, in the Seanad it was seen as a major Bill. It received a great deal of attention from all sides of the House. I enjoyed debating it. At the time I can recall visiting ICP and other places that engage in clinical trials to find out the best way forward for the business. We are confirming that the National Drugs Advisory Board are satisfied with the composition of the committee. It must be remembered that this is a major victory for the National Drugs Advisory Board because in the original Bill they were not mentioned. There was no formal recognition of the National Drugs Advisory Board who were recognised world-wide as an authority in the field. This amendment further improves the Bill. Many of us were anxious that there should be formal recognition given to the National Drugs Advisory Board. It is more than that now. They are accepted, and rightly so, as being very much an authorative grouping in this area of clinical trials. I support the amendments.

When this section was debated in the Dáil my party put down an amendment asking for statutory protection or a framework for the ethics committees. Having read the Minister's reply I was not persuaded that was necessary. The first amendment goes a great deal of the way towards meeting any of the worries people may have. I am always a little bit worried about ethics committees if they do not have sufficient protection. I wonder if after a certain period of the working of this Bill, given the very grave consequences of any possible abuse, the Minister would ask his Department to have a look at the role of ethics committees to see if they are constituted as both Houses would like them to be constituted and have the strength and protection which we would like to have. Otherwise, I think the first amendment goes a great deal of the way to meeting any reasonable worry anyone could have.

I would like to assure the Senator that we will very carefully monitor this Bill. This is a new piece of legislation which was required. We will check with Department officials and keep a very close eye on it to see if there is any lack in the Bill and if at any stage we feel it should be strengthened in any way we will have no hesitation in bringing forward proposals. We are satisfied with the amendments which were debated at such length here. They have made the Bill very strong. I am confident after listening to the debate in the Seanad and the debate which took place in the Dáil that I need not anticipate any changes because it has been so well studied and debated.

Just for my own purposes and to put everything in order, I circulated that document for the benefit of Members of this House. I would like to explain to Senators that the amendments made by the Dáil are not before this House as they have already been made to the Bill by the Dáil. The Bill is now before the Seanad en bloc and the practice is that the amendments made by the Dáil are taken in total on this Stage. It is not necessary to single out every amendment made in the Dáil. We had another piece of legislation last week which went as it should go. That was why I stated — and I am putting it on the record again now because there are rules for me as for the other Senators — that we should be discussing all these amendments which were made in the Dáil together and not individually. That is usually the way this House deals with amendments to a Bill that comes back to this House.

I shall act under your guidance. There are only a few amendments involved. If you wish me to go through all the amendments I will do so.

With regard to amendment No. 2, while discussing the provision of section 2 of the Bill during Committee Stage in the Dáil the Minister gave an undertaking to re-examine section 2 with a view to safeguarding the interests of participants in trials while at the same time ensuring against undue impeding of legitimate trials on products which have been authorised. The trials in question are done to determine new uses for products which have a product authorisation and which are in extensive use in medical practice. These trials are generally undertaken by hospital consultants and are of considerable benefit in determining new and beneficial uses for a widely used product on the basis of experience in using the product clinically.

In considering how best to develop an appropriate mechanism for clinical trials under section 2, the Minister found it necessary to restrict any deviation from the full requirements of the Bill to certain trials for new uses only. Trials involving a preparation which has a product authorisation where the purpose of the trials is to determine a new use for the preparation are now exempted, subject to certain conditions, from the requirements set out in section 3 to 6 and 8 to 11 of the Bill. The amendments governing the exemption includes the following stipulations: where the National Drugs Advisory Board have been notified in writing of the proposal and have, not later than six weeks after being so notified, made a recommendation to the Minister on the proposal and the Minister has granted permission for the proposed trial to be undertaken and, in respect of the substance or preparation concerned, the conditions relating to dosage and form contained in the product authorisation so granted are complied with while the clinical trial is being conducted and the dosage administered in each case does not exceed that specified in the said authorisation.

When assessing the application for the trial the National Drug Advisory Board have to be satisfied with the arrangements made by the applicant. These would include an independent committee to "vet" the trial. I feel that this amendment goes a long way towards meeting the legitimate demands of individual researchers conducting clinical trials while, at the same time, protecting those participants in such trials.

Amendments Nos. 3 and 5 to sections 8 and 10 of the Bill were moved by the Minister for Health on Report Stage in the Dáil. Under section 10 of the Bill a policy of insurance is required to ensure that adequate funds are available to provide appropriate compensation for each participant who may suffer injury or loss as a result of the trial, before a person can conduct a clinical trial. Under section 8 (4) (e) the ethics committee were to have regard to the insurance arrangements entered into. The requirement of a policy of insurance did not reflect the de facto position as regards the availability of various forms of financial compensation and security which are currently available to compensate persons who suffer injury or loss as a result of a clinical trial. Persons who conduct clinical trials at present have available to them arrangements which vary from policies of insurance to bonds and other financial guarantees from financial institutions and insurance companies.

It was necessary to recognise in the Bill that these arrangements exist. It would not have been appropriate to include a restrictive provision in the Bill which has as one of its objectives the facilitation of legitimate projects. Section 10 was amended to require that a person conducting a clinical trial must establish to the satisfaction of the ethics committee that he can provide sufficient security to ensure that adequate funds are available to provide appropriate compensation for each participant who may suffer an injury or loss as a result of the trial. Section 8 (4) (e) was redundant as a result and was deleted. It is the Minster's intention to include in guidelines for ethics committees the need for availability to such committees of expertise in the area of compensation for personal injuries.

Amendment No. 4 to section 8 was moved by Deputy Mac Giolla in the Dáil. The purpose of this amendment was to further safeguard the rights and interests of those participating in clinical trials by requiring the ethics committee to have regard to the method or methods by which volunteers are recruited. Amendment No. 6 to section 19 is a technical amendment. Section 19 (2) provides for the coming into force of the provisions of the Act. This was a technical amendment which arose from an incorrect reference in section 19 (2) to sections of the Bill. Section 19 (2) now reads as follows:

This Act, other than sections 16 to 18 and this section and so much of sections 1 to 15 as are necessary to give effect to section 3 (3) shall come into operation on such day as the Minister shall by order appoint.

I am very glad that we are finally about to get this legislation out of the Oireachtas. It is a badly needed piece of legislation. At the risk of flattering myself, I am particularly glad that amendment No. 4 was inserted, because that is an amendment I endeavoured to introduce in this House. The then Minister met it in some way but not completely. I am very glad it has now been introduced because, at the core of an enormous amount of public concern about the operation of clinical trials, in this city in particular, were the allegations — and in my view true allegations — about the methods by which participants are being recruited. There were uncomfortably large amounts of evidence that people were touting clinical trials in night shelters and hostels in this city and amongst people who were on very low incomes and who were, to say the least of it, susceptible to the offer of what was described as easy money for undertaking trials.

I am very satisfied with this Bill. I would like to compliment the former Minister for Health, and obviously the present Minister, on their work because this is an important Bill which arose out of the tragic circumstances in which a volunteer died. I am very grateful to the two Governments for pursuing this matter. It will not guarantee that vulnerable people will not be abused because this would be impossible to guarantee, but the safeguards built into this will ensure that in the future vulnerable people will not be nearly as open to being exploited as they were in the past. Therefore, I welcome the amendments. I welcome, in particular, amendment No. 4 because it ought to concentrate the minds of ethics committees on methods of recruitment of volunteers and ought to ensure that the old methods of going out to people in night shelters are gone. A parish priest of one area in Dublin who was visiting a night shelter in his pastoral capacity was asked by one of the residents of the night shelter who was paid "a tenner" for every volunteer he could recruit if he would do a clinical trial. These days are now over and I am very glad. I want to compliment the Minister on the fact that we are seeing this legislation. I would be interested to know if he has any idea of how quickly the Bill can be brought into force.

If I may reply to the Senator, it is our intention that when it finishes in the Seanad today we will put it forward for signature as quickly as possible in order to have no delays.

After signature, how long will it take?

We have to draft some of the requirements under the legislation. It is our intention to bring the Act into force in 1988 as quickly as possible. There will be no delay in the Department of Health.

I would have to admit freely that Senator Ryan was very vocal and very responsible in the long debate we had here in the Seanad. The first day it was brought in I suggested that it might be withdrawn totally. The Fine Gael side came in strongly and supported that. But for the behind-the-scenes activities of Senator Robinson perhaps it would have been withdrawn. She urged that perhaps we should leave it and amend it sufficiently. We did so and there were massive amendments, as has been said already by the Minister and others. I am satisfied at the end of it all that we have a much better Bill.

It is a very important Bill. I know many of the people who take part in these trials. They are vulnerable; they are social welfare people; they are people with low wages who take these trials to get money for a bit of extra furniture or to pay an ESB bill that is coming up, or whatever. Certainly they have to be protected and that is what the Bill is all about. I did not agree with Senator Ryan on some aspects of it but, by and large, I think we have got a better Bill. An amendment which he referred to regarding details of the proposed method or methods by which participants are to be recruited, is one I welcome. In fact, I wonder why do the companies not come clean and advertise in the papers. I know one of them is doing this now. There is nothing wrong with that. They have to come clean and tell the people of this country and the National Drugs Advisory Board and whoever else is involved how they propose to recruit the participants. I see nothing wrong with that. It should be open. The various companies engaged in clinical trials would welcome this as they would have nothing to hide. As a result of this Bill they can have nothing to hide.

Regarding the question raised on section 10, I recall that the original Bill almost suggested that because of the imposition of the insurance clause it was almost a no-fault policy of insurance which is not freely available and is quite expensive. The worry then was that the companies engaged in trials at university and medical school level would be severely handicapped and that they would have problems in getting insurance. We did not mind about the bigger ones that we felt would be able to look after that aspect of it anyway. This amendment by the Minister on Report Stage in the Dáil further strengthens the Bill. While it strengthens it in one way it gives some liberty — if you like — to the medical schools, to the universities and to doctors throughout the country who might be engaged in clinical trials, and to health boards and so on, in that they are now asked to establish to the satisfaction of the ethics committee that they can provide sufficient security. That will allow clinical trials and research generally in this country to proceed satisfactorily. That was foremost in our minds: we had to have a balance as between the safeguards for the participants, and the impositions for the people engaged in clinical trials.

The Bill generally has come right and set a proper balance for both the people engaged in clinical trials to allow research to develop in this country with proper recognition that safeguards should be there for the people the Bill is all about, the participants. I welcome the extra changes that have been made in the Dáil. They strengthen the legislation and I congratulate the Minister on bringing forward and accepting these new amendments.

Like Senator Ryan and Senator Fallon, I would endorse the view that this Bill did undergo a substantial improvement through the detailed Committee Stage and Report Stage in this House. The Bill as it left this House, was a very substantially improved measure. I agree with my colleagues that the further amendments made by the Dáil are acceptable in that framework and that they have, in fact, in one instance, as Senator Ryan has said, carried through an amendment which he had tabled. They also deal with one or two of the difficult issues that were considered at some length when this House was dealing with the Bill initially.

I would like to ask the Minister for clarification on one or two aspects of the amendments which the Dáil has made to the Bill. First of all, in amendment No. 2 and the proviso in relation to the National Drugs Advisory Board being notified, it says that "the National Drugs Advisory Board have been notified in writing of the proposal and have, not later than six weeks after being so notified...." I wonder if that is a very strict cut-off. If it so happened that the National Drugs Advisory Board, for one reason or another had not, in fact, made a recommendation to the Minister, are they unable to do so later than six weeks? The reason I pose that is that under the next paragraph there is no time limit on the Minister giving permission. It says: "... the Minister has granted permission for the proposed trial to be undertaken" but there does not seem to be any time limit within which the Minister would have granted that permission. It is simply a matter of clarification. Could the Minister explain why there is such a strict time limit on the National Drugs Advisory Board making the recommendation and can they make a recommendation if they are outside that six weeks? How does this square with the Minister apparently not being under any time limit in relation to granting permission for the proposed trial?

On the amendments in relation to the provision that it would no longer be necessary to have a policy of insurance by and large, I agree with Senator Fallon that, for reasons which were discussed at some length, it is better not to impose in all circumstances a policy of insurance. We identified in this House a number of instances where it would not be possible to proceed with the particular study or examination, particularly in a university context, or even by an individual practitioner who would not normally have and would to be able to obtain in any reasonable form a policy of insurance. However, it is important for this House that the necessary protection and safeguards should be there and it was implicit in the Minister's speech explaining the substance of the amendment that he is anxious that that protection would be there.

It would be helpful if we could have further clarification of the proposed explanation in the guidelines which the Minister has mentioned as to how a person would establish to the satisfaction of the ethics committee that he can provide sufficient security. Will this be dealt with in the guidelines by saying he can either have an insurance policy, or bond, or will itemise what would be sufficient security? The Minister, in referring to this amendment, said that it would be necessary that ethics committees would have expertise in the personal injuries field. Is it envisaged that ethics committees would have access to actuarial advice and expertise? This is a very difficult area. The ethics committees are being asked to perform an extremely technical and highly complex task and it is important that we maintain the balance so that the research work can go on in the interests of medical science and that the persons concerned who are participating are adequately protected.

Therefore, I would be grateful if the Minister in his reply could give as much information to the House as possible as to what assistance will be given in the guidelines, what additional expertise will be available to ethics committees and how a person would establish, to the satisfaction of the ethics committee, that that person can provide sufficient security in the circumstances.

I think these questions were mentioned in Senator Fallon's contribution as well and also in Senator Ryan's.

First, all Senators have contributed greatly to this Bill and have put a lot of work into it. In relation to the coming into force of this Bill, it is our intention that the Bill will be operational before the end of March 1988. We hope that the President will have the Bill signed before Christmas.

In accordance with the Constitution?

Yes, thank you Senator, that is correct. The guidelines are being worked on at the moment but until the Bill is passed we cannot finalise them. The non-statutory scheme will be in operation until the Bill comes into force at the end of March. We will bring the Bill in toto into operation at the end of March. It will not be phased in sections; every section will come into operation then.

In relation to the questions raised by Senator Robinson, the requirement is that the Drugs Advisory Board have six weeks to give clearance and that is a reasonable length of time. I want to put on record that it is our intention that within one week of the clearance the Minister will give the appropriate clearance also. That is not written into the Bill but that is our intention because there is a certain urgency involved in relation to clinical trials and, in fairness to applicants, they should not be left waiting for approval. This will be reflected when the guidelines are provided by the Department to the various applicants. Therefore, people will be aware of the requirements and of the fact that it is our intention, within the guidelines, that within one week of the National Drugs Advisory Board giving their decision the Minister will also give his imprimatur.

On Senator Robinson's point about having a policy of insurance, the ethics committees will have available to them an actuarial expert to advise in relation to the type of security needed, depending on the type of trial involved. It is very important, of course, that they would be satisfied that if, for instance, insurance was not available the company itself would be in a position, through bonds and other means, to provide security for the participants. It is our intention within the guidelines to make advice available to the committees to check the security being given, whether insurance or bond, by the companies involved.

I can only permit a question, Senator Robinson.

This is an important point. Would it be envisaged that the actuarial expertise would be provided by the Department to ethics committees or would it be a question of the ethics committees having to devise and find and fund their own actuarial advice? This is not really a sub-question of that; it is another question: will the guidelines be made available to the public or to Members of this House? The guidelines are very important in a Bill of this nature because, as the Minister has acknowledged, they will flesh out the statutory provisions and it is important that we should see the guidelines in due course.

The guidelines are not regulations under the Bill and there is no statutory requirement that they would be made available to the House.

They could be.

It is not our intention at this stage to make them available. They will be available to the ethics committees and to the companies and, I suppose, to anyone who wishes to see them. There is no great difficulty about that.

In relation to the insurance coverage, amendments Nos. 4 and 5 strengthen the Bill. As drafted, sections 10 and 8(4)(e) were weak as regards the role of the ethics committees in relation to satisfying themselves about the adequacy of the security available. The guidelines will make quite clear that it is a responsibility of the ethics committees to have actuarial experts available to these committees to advise in relation to security for participants in clinical trials.

Question put and agreed to.
Question proposed: "That the Bill do now pass."

I would like to thank the Seanad on behalf of the Minister and the Department for the co-operation which has taken place here. We appreciate the expertise within this House and the other House which contributed to this Bill and I believe this legislation will be a tremendous success.

Question put and agreed to.