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

Debate resumed on amendment No. 8a:

In page 9, subsection (4), between lines 13 and 14, to insert the following new subsection:

"(5) Any consent will only be valid if the consent in section 1 and the explanation in section 4 are given in the presence of a disinterested but informed witness.".

—(Deputy Flaherty.)

Miss Flaherty

I am anxious to press this somewhat further. I believe the whole purpose and strength of this Bill rests on two things. The ethics committee is absolutely central to this Bill achieving one of its major objectives which is the satisfactory control and protection of persons engaging in clinical trials. The Minister has not included guidelines in the Bill although he has indicated that he will consider on Report Stage including a commitment to make statutory regulations which would include a lot of the things we are looking for. However, as the Bill stands the role of the ethics committee is central. If the Bill is to achieve its objective we must be absolutely satisfied as to the composition of the ethics committee and that the guidelines in relation to consent are adequate. In the absence of a clear commitment from the Minister in relation to those it is important to press this somewhat further.

I am concerned that the net effect of this legislation will be restrictive in the area of the practice of clinical trials without ensuring beyond reasonable doubt that it will give significant protection. I ask the Minister to go into detail in regard to what he views to be the real application of the section which he asks ethics committees to have regard to and what is the legal interpretation of "having regard to". Does that mean that they can decide that medical examination is necessary or that a disinterested witness is necessary? If we are going to give them such loose powers of interpretation, the Bill hinges entirely on whether we have confidence in the ethics committee. With the position in relation to their nomination and the fact that we are still not clear about the guidelines in relation to their appointment, earlier discussions here indicated that extra amendments such as this would be desirable to ensure that it achieves one of its two major objectives which is to ensure that there is adequate protection for those involved in clinical trials. Therefore, I am anxious to press this amendment which ensures that consent would be given as is already recommended in the guidelines which the National Drugs Advisory Board themselves operate when persons seek advice on how to ensure that persons engaging in or volunteering for clinical trials are aware of all the implications of being involved and giving informed consent. What is the Minister's hesitation about specifying this?

Dr. O'Hanlon

There is already a key provision under section 9 (3) about the consent given by a participant to the person conducting a trial or to someone acting on behalf of that person. That can only be given if a person is capable of comprehending the nature, significance and scope of his consent. Section 9 (3) states clearly:

Any consent given for the purposes of this section shall not be valid unless——

(a) the person so consenting is capable of comprehending the nature, significance and scope of his consent, and

(b) it is obtained by or on behalf of the person conducting the clinical trial.

There is provision for persons who are physically disabled and cannot sign their consent or for persons who are unable to comprehend the nature, significance and scope of the consent of necessity to have a witness. It would not appear reasonable if, for example, a Member of this House wished to volunteer for such a clinical trial that it would be necessary for him or her to bring in somebody to sign on his or her behalf. There is an obligation on those carrying out a trial and on the ethics committee to ensure that the trial is carried out in a proper fashion. Indeed, I believe that it could be counterproductive to lay down by Statute the composition of that committee because it might mean that in certain cases where there would be a wish to have somebody with special knowledge included on the committee, it might not be possible to do so.

Section 8 (4) clearly lays down the matters which the ethics committee must have regard to. These are as follows:

(a) the objectives of the proposed trial and its planning and organisational structure;

(b) the qualifications and competence of each person who would conduct the clinical trial and, where appropriate, the resources available to him;

(d) the procedures proposed for compliance with section 9;

(e) the policy of insurance to which section 10 relates.

(f) the extent and nature of the medical examination that persons selected as participants are to undergo before participating in the clinical trial;

(g) the extent to which the health of participants is proposed to be monitored during and after the clinical trial;

(h) whether or not the persons selected as participants are to undergo independent medical examination before, during or after the clinical trial;

(i) details of any proposed inducements or rewards, whether monetary or otherwise, to be made for becoming or being a participant;

(j) any payments, whether monetary or otherwise, to be made to a person for conducting the clinical trial or any part of the trial;

(k) the criteria to be used to ensure that the identity of each participant remains confidential;

(l) any payments, whether monetary or otherwise, to be made to any person for facilities used for the purposes of the clinical trial;

(m) such other matters as may be prescribed by regulations made by the Minister under this Act.

There is a fairly comprehensive range of criteria to which the ethics committee must have regard before they approve of a trial. That committee are a crucial element in controlling clinical trials. Regarding the role of the ethics committee, under section 8 (4), this must be read with section 8 (2) which gives the ethics committee an effective veto over a particular trial if they are not satisfied that any of the requirements under section 8 (4) have been complied with.

Miss Flaherty

The legal phrase "have regard to" gives leave to consider these issues or not to do so. I am sure that if we had statistics we would find that Members of this House have not presented themselves for clinical trials except perhaps as impecunious students many years back. The reality is that many people participating in trials are perhaps in need of funds and are attracted for that reason. These people need to be given extra protection against themselves. In the event of a conflict as to whether the consent was given by somebody capable of understanding or comprehending, without the presence of an independent person to adjudicate, the typical participant in a clinical trial might not be adequately protected.

I believe that it is already the practice in major institutions to have their own independent medical examiner. They see this as being in their own interests. We must accept that the last thing any organisation or individual involved in research would wish for is an indication that they are careless or take risks. Obviously, that would undermine the value of the product or process that they ultimately approve. We have much goodwill among those involved to achieve proper regulations and it is my understanding that some of these bodies operate with an independent medical examiner. That proposal has been defeated in the House but the idea of having such a person to supervise a trial would not be objected to because anything that ensures greater stringency and avoidance of possible future incidence of disaster would be quite welcome. Freedom is given to the ethics committee to choose to implement any of these requirements. I am concerned about that because of the way in which the committee are first nominated. Clearly, any make-up of a trial might be different from any other, but there could be some tightening up. If this cannot be done under this section, it should at least be done in the area of nomination. That element should be taken out of the hands of the individual conductor of the trial and put into those of some publicly accountable body.

An Ceann Comhairle

Deputy Flaherty will, I think, agree that her amendment has been discussed in much depth and detail. May I now ask if she is pressing her amendment 8a?

Miss Flaherty

I shall not withdraw the amendment. The House has gone through the motions of voting on a similar amendment. I should like the amendment to stand, but shall not press it.

Amendment put and declared lost.

Section 9 agreed to.

SECTION 10.

Miss Flaherty

I move amendment No. 9:

In page 10, subsection (1), line 7, to delete "in force a policy of insurance sufficient" and substitute "adequate insurance cover".

We have to solve some outstanding issues in this section. The problems in connection with this section were debated during this Bill's passage through the Seanad and I regret that the Minister having introduced the Bill into this House has put forward no new proposals to resolve these problems. While it is clearly desirable that insurance cover should be obtained before a clinical trial is conducted we are, as the Minister has confirmed, breaking new legislative ground on a world-wide basis in what we are seeking to do in this section.

The twin objectives of this Bill are, first, to protect the volunteers and, secondly, to ensure that we do not interfere with desirable clinical research which may improve medicine, lead to new ways of reducing pain and to lives being saved. I am concerned that the only bodies who will be able to engage freely in clinical trials as a result of this Bill will be the independent institutes who engage in research on a profit making basis and the drugs companies. I am also concerned that private research which is undertaken by both doctors and universities will cease as a result of the requirement that insurance must be obtained before clinical trials can take place.

Insurance cover in this respect is provided only by two insurance companies in the world, Lloyds and an American insurance company, and it is very expensive. The problem may not be as large as we might fear initially because much of the research work takes place on original products which of themselves have insurance cover. Experience in the UK has shown that the insurance cover on the original product quite often covers further research work and the varied uses of that product by doctors. The only body who have not lobbied my party are the largest research institution in this country, the Institute of Clinical Pharmacology. This institute is making millions of pounds and without a blink of an eye will be able to comply with the regulations which will be imposed under this Bill. I have received much representation from doctors engaged in research for the purposes of the betterment of medicine. They are very concerned. Despite this Bill having been amended in the Seanad many of their concerns remain. I want to make it clear that the contracts under which these consultants are employed by the Minister for Health put a time limit on their research work and they concerned that if this Bill is passed their research work will cease.

As regards the treatment of terminally ill patients there are differences in how this Bill is interpreted. The doctors do not know whether this Bill will affect them. They believe it will, the Minister argues it will not. They are concerned that certain sections of this Bill will hinder important clinical research. I would like to refer to the views of Professor Feeley of the Department of Pharmacology and Therapeutics, University College Dublin. The Minister is aware of these views. He believes that research into terminal illness and cancer will have to cease due to the non-availability of insurance cover. The Minister's view is that this will form normal clinical practice and that therefore such studies will be exempt. However, the doctors involved believe, and they have received legal advice on this, that a ministerial assurance in the Dáil does not form a legal exemption.

I am satisfied that the section that deals with the treatment of individual patients will prove strong enough and will cover named patient clinical trials. I have no doubt that that would stand up in any court. However, a doctor may be anxious to engage in the trial of a new drug on a group of patients with a similar condition and this trial may be in the interests of those patients and if they are willing to participate the doctor should be allowed to undertake the trial but it may be impossible for him to obtain insurance cover.

Apart from the treatment of terminally ill patients, clinical trials are needed in order to make advances in cancer therapy, particularly in the area of leukaemia. Doctors argue that this Bill as it stands will prevent the best available therapy from being provided to patients and that they will become isolated from international bodies who carry out, and in some cases, fund such research. During this Bill's passage through the Seanad reference was made to the fact that the World Health Organisation withdrew research which was offered to institutes in this country and gave it instead to institutes in Belgium when it became clear that the requirement of insurance cover would be uniquely implemented.

I accept that this is a very difficult issue. It is obviously desirable that volunteers should be protected by insurance cover. The amendment I have tabled would help in a small way in that it would result in more applications being received for insurance cover than will result if this Bill is implemented. In the Seanad the Minister referred to the insurance he provides for consultants in certain areas and to the insurance which exists on the original product. A later amendment of mine has been ruled out of order because it would involve a charge on the Exchequer. I hope the Minister will take up the suggestion I made in that amendment which is to provide a voluntary fund similar to the one which exists in Britain which was established by the Department of Health and the drug companies and which provides indemnity cover for clinical trials.

I hope that the situations we are talking about will never arise. To date, with the operation of a voluntary system and with no requirement for insurance cover, no claims have been received in regard to trials which have been carried out within our hospitals through the Department of Health. I hope that that record will continue and that the setting up of this fund will allow desirable research to continue. Under stringent supervision, there would be no ongoing charge on the Exchequer. Possibly, I am now beginning to discuss two amendments at the same time but the amendment which I have proposed would be helpful in ensuring that any insurances which might be relevant would be accepted once the NDAB and the ethics committees are happy that they are applicable in this case. I ask the Minister to accept this wider definition as this whole section may have consequences contrary to our intent in the broad principles of the Bill. This amendment would alleviate some of the worries in this regard and would maintain the commitment to the requirement to have insurance.

Dr. O'Hanlon

I am glad Deputy Flaherty has raised this matter in relation to the insurance provisions in the Bill. I share some of her concern. On a point of principle, I feel that participants in all clinical trials, academic or otherwise, have the same right to compensation and to similar compensation arrangements. For this reason I feel that the same requirements should apply to each clinical trial whether it is carried out by one of the major multinational companies or by a consultant working in a hospital.

I acknowledge that under the current requirement in the Bill a policy of insurance does not extend to the types of financial arrangements which exist to compensate persons who might be injured during a clinical trial. While I accept the point that the major multinational companies are well able to take care of their own insurance arrangements and it does not pose a problem for them, I am concerned for consultants carrying out trials, for example, with products that already have a product authorisation but may come within the scope of the Bill. The provisions in the Bill as it is now may be too rigid. It is very difficult to cover every eventuality in a technical Bill of this nature. I feel we have developed a balanced approach for trials of the type referred to by the Deputy. At the same time, I am trying to develop a consistent approach to trials which have to comply with the Bill. This has to cover insurance. Deputy Flaherty had an amendment down to section 2 and we said that on Report Stage we would bring forward our own amendment to deal with that issue. This section must be looked at along with section 2 of the Bill.

In relation to clinical trials carried out on terminally ill patients, I have obtained legal advice and I am happy that trials of this nature are exempt from the provisions of the Bill under section 2 (2) (a) (i) and (ii). These paragraphs were inserted in the Bill to cover such trials. I intend to bring forward an amendment on Report Stage to deal with the insurance cover, particularly in relation to consultants carrying out trials in hospitals, say, where the insurance may be too rigid.

At all times, we must protect the interests of the volunteer, or the patient as it would be in that case, the person who is the subject of the trial. At the same time, we do not want to make the Bill so rigid that the normal clinical practice that is carried on every day in hospitals would be impinged on to the detriment of the patients generally. On Report Stage I will bring forward an amendment and will be considering it in the context of section 2 where we have already promised Deputy Flaherty we will bring forward an amendment.

Miss Flaherty

I welcome the acknowledgement of the Minister's concern in this area and his willingness to do something about it. Does he, therefore, envisage that section 10 will remain in the terms that it is or might that be more loosely defined? I share his concern to ensure that there is adequate cover and protection. Section 2 perhaps still leaves restrictions that might be dealt with but because they are related maybe we could deal with the two together. I gather amendment No. 10 is out of order?

An Ceann Comhairle

I will permit the Deputy to make some fleeting reference to amendment No. 10 but it is clearly out of order as it involves a potential charge on revenue. However, she may refer to it briefly.

Miss Flaherty

A problem remains in relation to amendment No. 9 if there is no move such as amendment No. 10 would provide. In regard to amendment No. 10, the problem as outlined by those who engage the doctors and have taken legal advice is that they could be open to cases being taken for compensation. We hope this will not occur but in the normal course in the light of the long history of accidents we have had in hospitals to date we may have to face this and the Minister's conviction, assurance or interpretation does not provide for them a legal exemption. Will the Minister undertake to have further discussions in relation to this and so satisfy himself that there is no further way of resolving it? Will he be good enough to refer to amendment No. 10? What it proposes can be done only on his initiative because it involves a charge on the Exchequer. The former Minister said in the Seanad that he felt it would be an open cheque which he did not wish to sign, but I do not accept that given the way it could be defined. Perhaps even the total cost could be met under the Minister's initiative by the drug companies? Will the Minister at least indicate his willingness to look at it? Will he have the powers to do it if we do not refer to it specifically in this Bill? When this Bill has been enacted and has been a year to two in operation, will it have the effect of reducing the level of research? Will the Minister consider a fund such as exists in the British system to ensure that our doctors are not cut off from the full practice of research?

There are three issues there: first, will the Minister look at the question that the doctors concerned have been advised that the Minister's interpretation does not give them an exemption in law from liability; secondly, does the Minister intend to leave section 10 as it stands; and, thirdly, with regard to a fund such as the British one, is it necessary to have reference to such in the Bill? I imagine it is not and that this could be dealt with outside the context of the Bill. Will the Minister put on record his views as to whether this is desirable or possible?

Dr. O'Hanlon

Participants in all clinical trials, academic or otherwise, have the same right to compensation and to similar compensation arrangements. For this reason the same requirements should apply to each clinical trial. As regards the compensation fund, I see certain difficulties. For instance, would the Bill be adequate to compensate in individual cases? We will have to take account of this.

As regards whether section 10 would stand in the event of bringing forward an amendment, I would bring forward an amendment if that would take account of the de facto position which should go some way towards meeting the points raised by the Deputy. The amendments for change in the whole section would have to be taken in conjunction with section 2. While I agree with the principles Deputy Flaherty enunciated, we do not want in any way to impinge on the ordinary legitimate practice in hospitals where consultants use legitimate products in varying doses which may bring them within the terms of this legislation. At the same time we must ensure that we protect the interests of the person on whom such trials are being carried out. We will be bringing forward an amendment which I hope will reflect the views and the principles enunciated by Deputy Flaherty.

Miss Flaherty

Will the Report Stage amendments be circulated in adequate time to give us an opportunity to consider them and ask the advice of those who are more expert in this field than ourselves?

Dr. O'Hanlon

Yes.

Amendment, by leave, withdrawn.

Amendment No. 10 not moved.

Section 10 agreed to.

SECTION 11.

An Ceann Comhairle

Amendment No. 11 is in the name of Deputy Mary Flaherty. Amendments Nos. 12 and 14 are cognate and amendment No. 13 is related. I suggest, therefore, that amendments Nos. 11, 12, 13 and 14 be taken together.

Miss Flaherty

I move amendment No. 11:

In page 10, subsection (1) (a), line 15, after "the Minister" to insert "or the National Drugs Advisory Board".

This amendment goes back to the original issue raised during the debate on section 1, that is, the role of the National Drugs Advisory Board and the role of the Department. The National Drugs Advisory Board have a staff of 43 people engaged in work which has been voluntary to date but which will become statutory in relation to clinical trials. They have many other functions relating to other areas. I should like the Minister to clarify the extent to which the Department will be involved in the day-to-day management of the functions covered by this Bill. Is it the case that the executive functions will be handled substantially by the National Drugs Advisory Board, as in the past? If the latter is the case, it is desirable to include these amendments so that it will not be necessary to refer to the Minister at all stages. To require immediate notification to the NDAB would speed up the process. Given that the original draft of this Bill was not the responsibility of this Minister, there appears to have been a lack of clear thinking in relation to the integration of the role of the National Drugs Advisory Board in the operation of this legislation. Is the Minister willing to accept these amendments with a view to reducing undue delays or bureaucratic roundabouts? How many people in his Department are skilled in these areas? What is the nature of their skills? Does he see his Department having a greatly expanded role in the day-to-day work arising from this legislation? Alternatively, will the National Drugs Advisory Board be responsible for most of the executive and detailed work, with the Department having only a monitoring role in the assessment of what is being done?

Dr. O'Hanlon

Regarding the personnel in my Department, of course we have medical advisers and pharmacists who will advise on the implementation of this legislation. Section 11 already obliges a person conducting a clinical trial to permit the inspection by an authorised person of a premises which the Minister believes is being used in connection with a trial. Section 11 also obliges a person conducting a clinical trial to comply with a request for information regarding the progress of the trial which the Minister or any person duly authorised may request. The person conducting the trial must also report to the Minister on becoming aware of or suspecting any adverse reaction affecting a participant in a trial. The Bill already provides that ministerial permission to proceed with a trial is on the basis of consultation with the National Drugs Advisory Board. That is provided for in section 4. As the Minister is to be designated as the competent authority to grant permission to proceed with clinical trials, it is consistent that he should be the person whose permission is requested and who is notified about a trial.

The Bill envisages a major advisory role for the National Drugs Advisory Board and a consequent close liaison between the Minister and the board in all areas relating to clinical trials. The amendments are unnecessary. The matters raised by Deputy Flaherty are well catered for in section 11.

Miss Flaherty

The role of the National Drugs Advisory Board will be an advisory one but the advice will involve ascertaining whether the trial is properly conducted in accordance with the regulations. This will involve looking at the documentation. Does the Minister intend that the National Drugs Advisory Board and the Department will both carry out these functions? Is it not the case that the National Drugs Advisory Board will be the executive arm of the Department in the implementation of this legislation? The fact that the Bill contains but a single reference to the National Drugs Advisory Board is an inadequate reflection of the role they will have to play. It sets a false responsibility upon the Minister. I do not believe two bodies should be carrying out these functions. Will the National Drugs Advisory Board be continuing the functions they had in this area, or will the Department of Health be designing 12 or 14 people on their staff to deal with this work? If it is the intention that the National Drugs Advisory Board should do this work — this is an indirect way of raising what is a fundamental issue on how this provision will be implemented and the role of that board — should that not be recognised in the legislation? If we want to give them authority to require information we are going a roundabout way of doing so. In my view it is against the Minister's policy of not having duplication.

I should like to know if the National Drugs Advisory Board will continue to function as before bearing in mind that they will have added responsibility following the passing of this legislation and that the regulations will be statutory rather than voluntary? Will the work that has been done by that body be carried out by Department officials in the future? If I was satisfied that there was a clear policy in regard to this matter I would withdraw my amendment but in my view the role of the board is not clearly defined in the legislation. Legislation which provides that a Department will handle such matters while in effect another statutory body will do so will not in the long term be good legislation.

Dr. O'Hanlon

I accept what the Deputy has said about duplication but I must point out to her that I do not envisage any duplication in regard to inspections. The Minister, speaking for myself, will designate the National Drugs Advisory Board to carry out a lot of this work, as they are doing at present, but it is important that the Minister, where he is the competent authority to grant permission for the carrying out of trials, should be in a position to designate the person or persons to carry out inspections on his behalf. In practical terms that will involve the National Drugs Advisory Board but from time to time the Minister may wish to have somebody else, perhaps an official from his Department, carry out such an inspection. In view of the Minister's responsibility under the Bill it should be for him to decide who carries out those inspections.

Miss Flaherty

Given that the Minister accepts that the National Drugs Advisory Board will carry out investigations under these sections more often than not I should like to know why there is an objection to including them in the provision so as to allow a certain flexibility and administrative clarity. If they wish to make inspections should they not have the freedom to do so? Would it not be a simple matter to add the National Drugs Advisory Board to the provisions?

Mr. Molloy

I fully support the Minister's explanation in regard to his role in this matter. Deputy Flaherty, in proposing her amendment, suggested that it might facilitate clarity but in my view it would cause confusion if there was to be a shared responsibility in regard to this. The Minister, as the person appointed by the House to carry responsibility for these matters, is the appropriate person to have the authority. It is worth noting that the Minister has the authority to refer matters reported to him to the National Drugs Advisory Board for advice. The Minister has taken the proper stand; he is the person who should carry full responsibility and should be reported to. I do not support the amendment.

Amendment, by leave, withdrawn.

Amendments Nos. 12 to 14, inclusive, not moved.

Section 11 agreed to.

Sections 12 and 13 agreed to.

SECTION 14.

Question proposed: "That section 14 stand part of the Bill."

An Ceann Comhairle

I have an indication that this section is opposed.

Miss Flaherty

I am opposing this section to allow the House an opportunity to discuss the issues raised by it. I do not have a fixed view on the provision because it is a specialised area that involves a certain legislative approach. However, I consider it important to discuss the section because concern has been expressed to me that this is an exception to all legal practice in that the onus of proof is on the person charged to prove that he or she is innocent rather than the person being presumed innocent until found guilty. It has been pointed out to me that in order to prove guilt or innocence in this instance it may be necessary to have a clinical trial such as was the subject of the charge in the first place.

Concern has been expressed to me that section 14 places the onus of proof for pharmacological or harmful effect on the person undertaking a trial. I have been told that in theory that may be impossible for an individual to prove or disprove and in some instances may involve undertaking a clinical trial. It has been pointed out to me that the insertion of this clause would appear to suggest something of a vendetta against clinical trials and to the man in the street be contrary to natural justice, innocent until proven guilty. I will be interested to hear the Minister's comments.

Dr. O'Hanlon

This section is linked to section 6 in which the definition of "conduct a clinical trial" appears. The term is defined as meaning the conducting of a systematic investigation or a series of investigations for the purpose of ascertaining the effects of the administration of one or more substances or preparations on persons where such administration may have a pharmacological or harmful effect. Section 14 provides that where a person has been prosecuted for an offence under section 13 and that it is alleged in respect of a substance that it was intended to be administered for the purpose of a clinical trial, the onus is on that person to prove that the substance may not have a pharmacological or harmful effect if so administered. This provision in the Bill would discourage an attempt, for example, to test a cosmetic for toxic effect under the guise of market research ostensibly to ascertain the attraction to consumers. In my view it is necessary to have the section in the Bill.

Miss Flaherty

Will the Minister develop the example he has quoted? Applied generally, is the provision fair? Is the Minister saying that if the product has a negative effect the onus of proof will act as an added disincentive? Is that not true in all cases? However, in this instance it is not like a legal case in that the connection between the effect and the person who uses the product is undeniable. Will the Minister develop that point in relation to how he sees it as being of value in increasing the protection in the Bill? I hope it is not a vendetta against clinical trials which would undermine one of the fundamental objectives of the Bill which is to ensure that clinical research, which will benefit medicine, will go ahead.

Dr. O'Hanlon

This is a safety measure to protect the person on whom a trial is being carried out to ensure that the product used does not have a harmful effect. It is an important section in that regard to protect the person on whom the trial is being carried out.

Miss Flaherty

Will there be a prosecution for an offence under section 13? If a person contravenes the provision of proper consent, will there always be a presumption that there was a harmful effect even if that is not the case? Are we saying that the elements of protection in the earlier sections in relation to ethics committees, consents, etc., are not adequate?

Dr. O'Hanlon

I am satisfied of the need for this section because in the ordinary course of events a person or persons carrying out such a trial or trials will have complied with the measures laid down in this legislation. Section 14 does not apply to persons who have ministerial permission to carry out such trials. It merely applies to persons who carry out such trials outside the provisions of the Bill, for example, somebody trying out a cosmetic which could have harmful effects.

Miss Flaherty

I should like more time to think about this matter. I will consider the information which the Minister had given and if I am still unhappy about it I will put down amendments for Report Stage.

Question put and agreed to.

Sections 15 to 19, inclusive, agreed to.

Title agreed to.

Bill reported with amendments.

Dáil Éireann debate - Wednesday, 11 Nov 1987

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

Dáil Éireann debate -
Wednesday, 11 Nov 1987