Dáil Éireann - Volume 371 - 26 March, 1987

Control of Clinical Trials Bill, 1986 [ Seanad ]: Second Stage.

Minister for Health (Dr. O'Hanlon): I move: “That the Bill be now read a Second Time.”

The purpose of this Bill is to provide a legal basis for the control of clinical trials involving human participants. The statutory [550] scheme provided for in this Bill will replace the current informal procedure whereby proposed clinical trials are voluntarily notified to the National Drugs Advisory Board and where such trials are then carried out in accordance with guidelines issued by the board.

Mr. Birmingham: On a point of order, does the Minister intend to circulate a copy of the script?

Dr. O'Hanlon I hope it will be circulated within minutes. It is generally accepted that there is a continuing need for more efficacious and safer drugs. However, this general acceptance is not always accompanied by an acceptance of the need for clinical trials in developing these drugs.

The thalidomide tragedy clearly demonstrated the need for great care in the study of new medicines before they are licensed for general use. Experience since then has also shown that even medicines which have been thoroughly assessed prior to marketing and are apparently innocuous need to be closely monitored for some time after their release into widespread medical use. Clinical trials are essential not only in the process of development of new drugs but in the continued assessment of drugs already on the market to ensure their safety, quality and efficacy.

In the pre-marketing stage this process of development is a lengthy one involving various stages of investigation ranging from chemical development to experimentation on animals and finally to testing on man. The tests on man are extensive and include: (i) those carried out on healthy volunteers; (ii) on patients suffering from the condition for which the medicine is intended to treat; and, (iii) on patients suffering from certain complications which could affect the behaviour of the medicine under trial in the body.

The ultimate objective of the process is to ensure the availability of (i) a safe and efficacious medicine for treating a particular illness or condition, and, (ii) which conforms with safety, quality and [551] efficacy criteria laid down by national regulatory bodies for the marketing of such medicines. In assessing applications for the marketing of medicines, stringent regulations apply to ensure the protection of public health and these include the need to supply detailed results obtained from clincial trials. There is a regulatory requirement in most countries, including Ireland, that the results of such trials on a particular medicine be furnished for evaluation prior to authorising its placing on the market. In Ireland, the detailed assessment is carried out by the National Drugs Advisory Board which then advises the Minister for Health in relation to the issue of a product authorisation or licence to market the medicine here. However, the question of the involvement of humans in clinical trials has received much public attention in recent years. This has prompted an examination, at both national and international level, of the controls applicable to such trials.

At international level, the World Health Assembly adopted, as far back as 1964, the Declaration of Helsinki which contains recommendations guiding physicians in biomedical research involving human subjects. The Declaration has been revised on two occasions since, in 1975 and 1983, and compliance with it is a prerequisite for approval of clinical trials by most drug regulatory agencies.

In Ireland, there is no basis in existing legislation which would provide for a statutory scheme to control the conducting of clinical trials and there has been some public disquiet about the absence of such statutory controls. The current arrangements for the clearance of submissions for trials through the National Drugs Advisory Board have been operating for a number of years and conform with internationally accepted principles. However, they fall short of those required by virtue of the fact that they are carried out on a voluntary and informal basis. It is now generally accepted that comprehensive controls of all trials must be guaranteed by a statutory scheme as provided for in this Bill.

The Bill is drafted in a manner which [552] provides wide scope for control and, at the same time, ensures against rigidity in relation to interpretation of the provisions. This form of drafting is vital when one considers the extent, range and nature of clinical trials which must be carried out. I believe that it is most important that we avoid introducing a statutory scheme which would be so rigid as to impede the pharmaceutical industry here in completing the drug clinical profiles required by drug regulatory agencies for evaluation prior to market.

At the same time, however, it is vital that the new statutory scheme must also safeguard the health and rights of those participating in clinical trials. We must ensure that the interest of medical science and society in general should never take precedence over considerations relating to the well-being of the participants.

Section 2 provides for an exemption from most of the controls in the Bill of trials where the drug being tested has a product authorisation, provided that the National Drugs Advisory Board has been notified of such trials. While it is accepted that it is necessary to relieve such trials from the full controls of the Bill, it is important to ensure that the authorities are aware of the details of such trials.

Basic to the nature of the control regime for clinical trials proposed in the Bill is the requirement that the prior approval of the Minister for Health must be obtained by a person wishing to arrange for the conduct of a clinical trial. As I have said, a clinical trial involving a product which already has a product authorisation would not, however, require the prior approval of the Minister but would have to be notified to the National Drugs Advisory Board.

The details to be included in applications are outlined in section 3 and the information required is such as will enable the Minister to satisfy himself, inter alia that the proposed ethics committee is so constituted as to afford assurance that the justification for the trial will be carefully and impartially considered; that the doctors or dentists who will be conducting the proposed trial are suitably qualified and competent to do so; that [553] the method of recruitment and selection of participants is satisfactory, and that the level of rewards to be made to participants is not such as to constitute an excessive inducement.

While formal approval will be a matter for the Minister, he will rely on the expert advice of the National Drugs Advisory Board in arriving at his decisions. All applications will be referred to the board for assessment and for recommendations as to any conditions which should be attached to the Minister's permission. Section 4 empowers the Minister to apply whatever conditions he considers necessary for the safe conduct of the trial.

The need to have the Minister's prior approval to any change in a subsisting permission and his authority to request information on the progress of the trial, and to intervene when necessary, is recognised in the Bill. For example, section 5 provides that any proposed variation to a subsisting permission must be subject to approval by the Minister. The Minister will also have the power, as provided in section 7, to revoke, at any time, a permission granted.

Section 11 empowers the Minister to arrange to have inspected any premises in which a clinical trial is being conducted and to require such information as he deems fit about the progress of a trial. It also obliges all persons involved in the conduct of a clinical trial to bring to notice promptly any adverse reactions or suspected adverse reactions which come to light in the course of a trial.

In accordance with internationally recognised standards, section 6 of the Bill makes it a requirement that a clinical trial may be conducted only by a registered medical practitioner or a registered dentist. The definition of the phrase, “conduct a clinical trial”, 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. Specific exemptions are provided for in this section for practical demonstrations of the effects of known drugs in medical, dental and pharmacy classrooms and for [554] nutritional studies involving normal dietary constituents.

Ethics committees have a key role to play in deciding on the legitimacy of proposals for clinical trials and in the supervision of the manner in which such trials are carried out. Section 8 of the Bill requires that there shall be an ethics committee to consider and report on the justification for a clinical trial before that trial commences.

Central to the area of concern to an ethics committee would be the need to ensure that the risks to the participant do not outweigh the objectives of the trial. Guidelines will be drawn up for the information of applicants so that they will know what the Minister might be expected to approve of in terms of the composition of such committees. I am sure that all involved in the conduct of clinical trials will accept that the public have a right to feel satisfied not only in regard to the competence but also the independence of these committees.

Also of particular concern to the ethics committee would be the matter of consent of participants. It is of fundamental importance that a proposed participant must be given sufficient information, in a comprehensive form, to enable him or her to make a proper judgment whether to participate or not. This matter is dealt with in section 9 which also requires the participant's written consent and specifies his right to withdraw his consent at any stage. Special provisions are also included in order to protect patients who are unable to give written consent or to understand the nature of the consent. A further protection in the case of a patient is that such patient may only be used in a clinical trial if the drug under trial is to treat his or her condition.

The question of payments to participants in clinical trials is a contentious one. It has been suggested that socially disadvantaged groups, such as the homeless and unemployed, are exploited and influenced in their decision to participate in a clinical trial by the expectation of significant financial gain. To allay concern in this regard, the payments to be made to participants must be in accordance [555] with those specified in the permission of the Minister, as provided for in section 9 (8). It is envisaged that such payments will be confined to a level which would not provide undue inducement to persons to participate in a clinical trial.

A further safeguard in relation to persons participating in clinical trials is provided in section 10. This requires that the person arranging must ensure that there is in force a policy of insurance which would be sufficient to ensure that adequate funds are available to provide appropriate compensation in the event of the participant suffering injury or loss as a result of the trial.

There are several offences created in this Bill. Section 12 makes it an offence for any person to provide, or cause to be provided, to another person incorrect or misleading information etc. either for the purpose of an application or in relation to the trial itself.

This should ensure that the information which accompanies the application or which is reported in accordance with section 11 is accurate and unambiguous.

Section 13 specifies the other wide-ranging offences which will apply. This section also includes a “good defence” which would apply in a situation where the medicine was administered in the case of emergency medical or dental treatment.

Where a person is prosecuted for failure to apply for permission to carry out a trial, section 14 stipulates that the onus of proof will be on that person to show that the substance or preparation administered may not have a pharmacological or harmful effect and that, therefore, the activity in which he was engaged did not constitute a clinical trial.

Section 15 provides that penalties up to a maximum of a £10,000 fine or imprisonment for a term not exceeding three years, or both, will apply in the case of conviction on indictment.

Section 16 empowers the Minister to charge fees in respect of applications made. In accordance with general policy in these matters, the scale of fees will [556] be geared to ensure that this statutory scheme will be self-financing.

In conclusion, I trust that the description and general philosophy of the Bill which I have outlined will satisfy the House both as to the need for a statutory scheme to control clinical trials and the reasonable nature of the provisions proposed.

I hope that the explanation I have given of the background to the provisions in the Bill and the impact they are intended to have will be accepted as a fair balance between the need for protection of individual health and welfare and the legitimate and necessary requirements of medical research.

I might add that there was a full discussion on the Bill in the Seanad during which several amendments, some of which were of a substantial nature, were accepted and are now included in the Bill. In this context, I thank my predecessor, the former Minister for Health Deputy Barry Desmond for the manner in which he dealt with the Bill during its passage through the Seanad. He accepted a number of amendments which were put to him. I would also like to thank all the Senators who participated in the debate, especially my colleague, Senator Sean Fallon our spokesman on Health for the manner in which he facilitated the processing of the Bill in the Seanad and for the significant contributions made by Senators in developing the Bill.

The Seanad, as a whole, was happy to accept the Bill and it represents a consensus view of the Upper House. Against this background, I am confident that this Bill will be accepted and passed by the Dáil and I look forward to the help and co-operation of the Members of the House in its enactment.

I commend the Bill to the House.

Mr. Birmingham: Perhaps the Chair will permit me to preface my remarks by congratulating the Minister for Health, Deputy O'Hanlon, on his appointment. I wish him well during his period of office. I join in that Deputy Leyden, Minister of State. I know that role is sometimes a less than entirely satisfactory one but I [557] am sure the partnership opposite will be a very harmonious one and I wish both of them well.

The Minister concluded his remarks by referring to the legislative history of this measure. Given that history it will not come as any surprise that the measure will receive the support of Fine Gael. The Bill is essentially that which was introduced during the lifetime of the previous administration. It now comes before the House as amended in the Seanad. In those circumstances, it is not necessary to make a long contribution because the debate which took place in the Seanad was a very full and valuable one. Those who have suggested that we could usefully dispense with the services of the Seanad might benefit from reading the Seanad Official Report. They would see the valuable contributions which were made by Senators on all sides and who approached the matter in a non-partisan way.

They approached the matter, as I do today, knowing that it was a measure of importance and one on which a certain amount of sensitivity had to be brought to bear. It was recognised that there was need for balance — balance between the needs of the pharmaceutical industry and wider medical research and the danger of slipping into excessive rigidities; balance between the needs of the volunteer and the need for the test to proceed satisfactorily.

The discussion that took place in the Seanad and the openness with which the then Minister responded to the various suggestions and amendments has ensured that the measure before us is a much improved one from that originally proposed and comes very close to the required balance.

In the past this area was not subject to statutory control. It was, of course, the subject of various voluntary arrangements and codes of practice but there was legitimate public concern that this was not an adequate response to an area of such importance. That public concern was intensified by a number of much publicised cases and one in particular which became the spur to action in this regard. [558] In an area where there are so many conflicting interests it is important that there should be statutory control and that the person who should exercise that control should be the Minister for Health advised by the experts in the National Drugs Advisory Board. That is important because some of the interests involved are not in a position to press their interest and others are vulnerable to the danger of exploitation. There is concern that the consent, which should be an essential part of the process, might not always be a free and informed consent. There is concern that unduly generous inducements might encourage people to act against their best interests. There should be a clear cut and detailed procedure to which people could refer and in which they would have confidence.

The measure before the House achieves that objective and for that reason we are prepared to accept it. Perhaps the Minister might have a look between now and Committee Stage at the position of people other than doctors and dentists, for example, physiotherapists. This point occupied the minds of some Senators and the Minister seemed happy with it but reading the Official Report I was not altogether reassured on the point.

I do not want to delay the House unduly. We are happy to support this measure. The central question is to get the balance right and the Seanad went very close to doing so. However, we will be asking questions on Committee Stage so that we can all be satisfied that we have achieved what we set out to do. It is not a measure on which there should be any political controversy. Our objectives are the same and the Minister has done a good day's work in deciding to proceed with this measure introduced by his predecessor.

Mr. Keating: I welcome the opportunity to speak on this important Bill and I join with the previous speaker in wishing good luck and success to the Minister for Health and his colleagues.

This Bill was debated comprehensively in the Seanad which helped to improve [559] it. In that context, it is right to say that the Minister at the time was extremely open-minded and flexible in bearing in mind the contributions of Senators and taking on board many of the submissions made in the Seanad and outside at the time. Flexibility and open-mindedness are not necessarily always a feature of debating and the devleopment of Bills and perhaps it may give an example to others who are a little more rigid in their approach to legislation so that real progress can be made in this House.

This is a regulatory Bill but we should not assume the State has the automatic right in all cases to intervene and regulate the normal affairs of people. Over the years perhaps we have been a little too glib in our acceptance of the plethora of Bills introduced in the House — some more important than others — all concerned with regulating activities of one kind or another. In a matter affecting public health such regulations are reasonable, or at least the assumption that there should be such regulations is reasonable. However, when a Bill of this nature is being introduced the Minister and his colleagues should spell out the reasons in principle for its introduction and explain why a regulatory mechanism is necessary and desirable. That has not been done and the Minister's speech this morning is no exception.

It is somehow assumed that the State has the right to introduce Bill after Bill into the House controlling all sorts of activities without explaining why the State feels it necessary to intervene. As a basic philosophy that should be done in future. Otherwise we will end up with a maze of expensive bureaucracy, most of it non-enforceable, cluttering the Statute Book. This all adds to a labyrinth of expensive non-enforceable regulatory machinery which ultimately comes back to the desk of the Minister without any clear overview of the role of the State visà-vis the citizen in such matters.

From the point of view of my party, there should be a clear statement explaining the obligation felt by Government to become involved. Such an obligation is [560] clear in this case. One does not quibble with the State's involvement in introducing some form of regulation in an area which, up to now, has operated totally on the basis of voluntary codes which were enforced honourably and in good faith by the vast majority of the agencies involved in this field but which, nevertheless, caused some problems and indeed led to a tragedy in recent times. It is important, therefore, that there should be some framework of regulatory control in this case affecting the health and safety of volunteers. The major implication in this Bill is in relation to the health and safety of citizens because the benefits of such research have clear and direct implications for the health of the general public. My understanding is that control and regulation by the State in matters of this kind are welcomed by all responsible practitioners.

I am pleased to see the involvement of the National Drugs Advisory Board as a mechanism or sounding board for the Minister to obtain his views in relation to various matters. I do not mean any disrespect to the Department but I was not overwhelmed with enthusiasm at the prospect that the ultimate safety line was referral to an clearance by the Minister in relation to allowing certain tests to take place. The Minister and the Department quite often operate the science of administration as outlined in Clive Ponting's book Whitehall: Tragedy or Farce. Some people see administration not so much as an area of particular expertise but as a general science which has certain standard rules. In this case, a clear, detailed, professional knowledge of the full medical and health implications is essential and, therefore, the skill and independence of the National Drugs Advisory Board are vital to that exercise.

It would be no harm if in this and future Bills the cost of the enforcement which will be in place if the Bill is passed was made clear to the Department and the public so that we would all have a better idea of what is involved. I am talking about administration, enforcement and regulatory costs and, in this case it would be a good idea to give consideration to the [561] possibility of asking the drug companies, most of them internationally based, to pay the costs. There would obviously be practical difficulties in enforcing that but the principle is right and I do not see why the ordinary taxpayer should foot the bill for the development of drugs, the sale of which, in due course, will make substantial profits for the companies involved. I do not believe they would necessarily be averse to paying the costs involved.

This is a timely measure. In The Lancet of 18 October 1986 the editor drew attention to the increasing number of contract companies now providing facilities for the conduct of phase 1 studies, the initial volunteer testing. He expressed concern in this regard and any review of the question of clinical pharmacology involving normal healthy volunteer subjects which fails to address this very important issue is clearly inadequate and might even be of questionable value in terms of the findings of such research. That is a very important element in this equation: it is not merely the very important question of volunteer safety but the validity of the scientific findings emerging from such research. The calibre and the parameters of such research are vital if we are to stand over the validity of what emerges from such work.

Quite clearly, the international drugs industry is in the business of major profitability. I should like the Minister to look into the area of generic drugs and, like his pedecessor, examine the significant exploitation in this area by international drug companies, sometimes, willingly or otherwise, having as their accomplices lazy medical practitioners or others to see whether the general cost of the health services in the drugs area could be reduced. It is not appropriate to go into that in detail in the context of this Bill but it is an area of public concern and, I have no doubt, of Exchequer concern.

Here too, in this area there is money and wherever there are money and profit we will have not just what I assume to be the majority of genuine people and practitioners but also the other unscrupulous [562] exploiters who will be attracted by the possibility of making the quick buck by cutting corners and taking avoidable risks. Unfortunately, these get-rich-quick operators who are not prepared to invest adequately in personnel and facilities to ensure high safety standards will without too much trouble find cost conscious drug companies to co-operate with them. These companies will perhaps want phase 1 studies done down to a price rather than up to a standard and we all will suffer as a result. This worrisome trend is causing concern among the more conscientious and ethical clinical pharmacology institutions and to the Minister and many members of the public. Evidence has been lacking thus far that Government agencies, even those with fairly toothless guidelines, are prepared to take effective action to curb and eventually eradicate the purveyors of cheaply priced feed-and-bleed services who masquerade as ethical practitioners of medicine. This Bill may be the first step in that direction. I hope so and I hope that its enforcement is clear and not just a cosmetic exercise which is not meaningful.

Diligently monitored phase 1 studies play an indispensable role in protecting the population at large from unnecessary exposure to potentially toxic drugs. Examination of any text book of adverse drug reactions will establish beyond argument that the array of drugs available today for the treatment of disease carry with them a varying degree of risk of injury to the patient. This risk can be greatly reduced by conducting these studies initially and the benefit to the community of such trials is vast. I have no doubt that if such testing and trials were to cease the whole science of development of drugs would in itself slow down if not come to a complete stop. That is not to say that drugs are the absolute solution to health matters or necessarily the primary solution. I look forward to another opportunity in this House of developing thoughts on alternative ways of looking at some of the health care problems we have at present.

Who then should become a subject of medical research? We should at least suggest [563] a new way of looking at this problem. Up to now perhaps the human volunteers were quite often people who were obligated by social or economic circumstances into volunteering. They were generally people who had no other way of making an income, who were unemployed, students who were hard pressed to make ends meet and people who were generally vulnerable. From every point of view, ethical, justice in society, even of public safety, this is not desirable or acceptable. Therefore, from now on we should look on this area not as somehow carried out by companies using a small category of people who are prisoners of that system, so to speak, but that all of us have to some extent a moral obligation collectively to develop higher standards in the area of drug testing. If the standards we are presenting this morning are safe, proper and comprehensive enough, what would be wrong with each one of us accepting our quotient of responsibility in the same way, for example, as we or societies do in all kinds of areas such as jury duty, paying our taxes, maternity leave for women and so on? In other words, each of us could accept that this is not something that drug companies are in the business of for the purposes of making money per se but that it is of fundamental benefit to our society and that therefore all of us have an obligation to co-operate. That would mean that each of us would see that we must take part in the development of new medical weapons with which to fight disease to save lives, that in theory it is necessary to take part in research projects. In that context and in the context of centrally regulated controls which are seen to be fair and safe we might even suggest that persons who would then be unwilling to play a reasonable part perhaps once or twice during a lifetime in helping to find new therapies from which they and their families might need to derive benefit to ease their pain and diseases and prevent premature deaths, would be lacking in commitment to society in general.

That is not the way such trials are thought of at the moment and perhaps [564] there is a degree of naïvety about this suggestion but I think we could assist by doing one or two things. For example, it seems not unreasonable to encourage employers to give employees time off and perhaps pay them for their absence if they volunteer to help in this area. Certainly participation by human volunteers in the early stages of drug development is vital, lawful and, I suggest, morally compelling. It is also required by international drug regulatory authorities before any drug be made available on prescription. Therefore, up to now to an extent in getting the higher standards of health care that we enjoy from that element of the health services which relies on drugs and drug related therapies for qualitative improvements, we have been relying on a small group of people who I argue have generally been pressured into the business of subjecting themselves to these tests. Perhaps we owe them and society in general a debt because of that.

With a few exceptions the behaviour of a drug in the physiological normal body must be studied before its behaviour due to pathology can be established. If that is the case, why should the responsibility rest on those who have no other choice but to volunteer? Why should each one of us not say that it is in everyone's interest, that therefore we must do our part? If for any reason healthy volunteers cease to be available clinical research in the treatment of disease would not progress further. It is certain that the necessary advances in the treatment of disease will continue only if volunteers are permitted to make active contribution. In the absence of this contribution progress will cease and therapeutic stagnation will result. However, to volunteer to be a subject of medical research entails, like many other human activities, some degree of risk to life and health, therefore we must accept there are risks.

With the exception of a few special varieties of drugs the phase 1 studies are conducted in normal healthy male volunteers aged between 18 and 45 years who are not on medication and who are not excluded for reasons of drug abuse [565] or mental incapacity. In addition to being suitable as defined by the inclusion criteria spelled out by many such companies and businesses in the protocols they use, the normal, healthy volunteer must be not only suitable but available, and that is where the crux arises. Availability constitutes the greatest limiting factor to volunteer population pool size. I would be interested to know if there are studies in the Department indicating how many people will volunteer in this area. I suspect the number is very small and they are quite often the same people over a time subjecting themselves to repeated drug testing.

We should not ask that group of people to carry our burden for too long more. Many people subject themselves willingly to volunteering blood, for example, for the purposes of the common good. Unlike the time factor involved in being a blood donor which is obviously quite short, the phase 1 volunteer has to commit time to the project which can be measured in days or even weeks rather than hours. That is a major problem. Therefore, if we are to accept that in today's society we still lack the enlightenment of regarding volunteering for clinical research as laudable, it means that volunteering for phase 1 clinical research is confined to a few social groups — students, drug firm employees, members of religious communities and those particularly for whom work opportunities do not exist and are unlikely to exist in the foreseeable future. If a civilised organised society is able to accept that its citizens are entitled to leave of absence from their places of employment for weeks or months with full remuneration to serve in the armed forces, to have babies, to have medical or surgical treatment, to prepare for the Olympic Games or to do a thousand and one other tasks which are seen to be in the public interest, is it reasonable that they might also recognise the right of the citizen to fulfil a moral obligation to participate in clinical research in this case? If so, would it be possible to extend the same parameters of conditions and flexibility in terms of on-the-job availability and so [566] on to people who so wish to volunteer? Perhaps there might even be considered a legal requirement on employers to grant leave of absence to employees who wish to participate in clinical research. Such a privilege could be restricted to, say, not more than twice in the working lifetime — for example, once under the age of 45 and once over the age of 45. The recompense to the subject would be related to his normal remuneration for which the sponsor of the research project would be responsible.

That is not an unreasonable proposition and I would be interested in the Minister's reaction to that suggestion. The research volunteer must also be guaranteed financial protection against injury. Up to now that has been far from clear. Future legislation should ensure that a suitable and appropriate mechanism be designed and in place to protect the volunteer against accident or abuse. Obviously a cap of some kind has to be placed on the amount of money that should be awarded in those cases but that insurance should exist in the event of something going wrong.

A very important element of this issue is that there has been a very serious deficiency in the survelliance of volunteers in so far as at present there is an inability to identify all volunteers who have recently been involved in either research projects or medical treatment elsewhere. The methods of detection are never likely to be adequate to replace the absolute necessity that volunteers in their own best interest provide complete and accurate details of their previous medical history. I am not commenting on any individual cases but because of the pressure which individual volunteers may feel for economic reasons they may not be fully forthcoming with regard to stating clearly their previous medical history or indeed whether they are at that time taking drugs of one kind or another. That is a serious deficiency. I wonder whether or not the Minister will consider asking the National Drugs Advisory Board for their view on whether it might be required of each volunteer to present an up-to-date medical certificate of his [567] health condition and whether or not he is on drugs of one kind or another. Obviously a volunteer can also lie to a doctor but this would at least be an attempt to solve an issue which is of concern and which, in the context of the present small pressurised group of volunteers that exist, is very relevant. If a person needs the money he will volunteer. If he needs the money badly he will undoubtedly be less than totally forthcoming if circumstances exist which will stop him from becoming a suitable volunteer. We should try to protect people from themselves in a case like this.

Due to the capacity of the agencies involved in drug testing to now advertise for volunteers the numbers of people volunteering are much greater than heretofore. There have also been significant changes in the socio-economic standing of many of these volunteers and that is not a bad thing. The contribution that the healthy volunteer has made in the past and can make in the future of the advancement of theraputics is inestimable. We owe such volunteers a debt because they have helped us all. It is high time that this fact was recognised by society as a whole. Some degree of the obligation implicit on all of us who are involved in development and use of drugs to ensure this recognition is forthcoming cannot any longer be evaded. Contentious utterances of one kind or another are not or any great help in a case like this. If such testing was to cease or to be discouraged all of us would suffer and that would be very bad.

The Minister made some points which are very worthy of being underlined. He said that in Ireland a detailed assessment is carried out by the National Drug Advisory Board which then advises the Minister for Health in relation to the issue of a product authorisation or licence to market the medicine in this country. I would like to see the National Drugs Advisory Board brought out a little more from the shade and being asked to issue regular reports more often, particularly in areas like this, for the benefit of the community.

[568] Health is a matter primarily for each individual. The framework of the health services and all the internal mechanisms, drugs and services that exist are facilities but the ultimate responsibility rests on each and every one of us. The Health Education Bureau, in this case the National Drugs Advisory Board and the other agencies involved, should do everything possible to issue clear, simple and regular statements to advance the knowledge that is available in this area. It is perfectly reasonable that we should benefit to the maximum extent from international advances in relation to drug testing and that wherever possible there should be no need to re-invent the wheel. If work has been done I assume the National Advisory Board will take it on board. I wonder if the Minister will confirm what the position is about taking up research already done in such areas.

The Bill is drafted, as the Minister said, in a manner which provides wide scope for control. One aspect struck me as being open to some query, that is the right of the Minister to be able to stop a trial once it has begun. That might have the effect of discouraging investment in proper facilities. I wonder whether or not that is necessary. If all the parameters the Minister requires are in place and if the safeguards are there I wonder in what circumstances it would be necessary for the Minister to intervene, over and above the authority who got the agreement in the first place, and insist on the trial being ceased.

The Minister said that the prior approval of the Minister for Health must be obtained by a person wishing to volunteer for a clinical trial. That is proper. I do not know what the precise mechanism is for that and I wonder if the Minister can spell it out. Does it mean that every time a specific trial is to be undertaken a specific certificate will have to be issued? Will there be some kind of monthly certificate or what happens if there are sub-testings involved; I hope that will not result in a paper mountain where people who should be involved in helpful research in the drugs area will spend half their time filling up forms and [569] inspectors from different Departments will be involved in the vetting of such certificates.

The Minister spoke about a number of factors which are germane to the Bill. He said that the proposed ethics committee should be so constituted as to afford assurance that the justification for the trial will be carefully and impartially considered. He said that the doctors or dentists who will be conducting the proposed trial should be suitably qualified and competent to do so, that the method of recruitment and selection of participants should be satisfactory and that the level of rewards to be made to participants should not be such as to constitute an excessive inducement. Could the Minister harden up a little on that? He is saying today that the details to be included in applications are these, broadly speaking. I wonder if that should be written into the Bill so that it is not an optional matter and so that on every application the Minister or his Department officals do not have to check whether the level of awards is not excessive or that the proposed ethics committee is so constituted and so on. Why not write those into the Bill so that they are standard norms which apply in relation to the constitution of, say, an ethics committee? A couple of hours of discussion would probably come up with the obvious conclusions that they should be independent of the company and should embody a wide range of expertise, perhaps involving the Minister's nominee. Why have such flexibility in what most people will see as commonsense requirements which the companies would probably welcome? Some have their own ethics committees already in place. Why have to go through the bureaucratic examination of each application in these respects?

Would the Minister clarify what he means by saying that while formal approval would be a matter for him he will rely on the expert advice of the National Drugs Advisory Board? Does that mean he will automatically accept such advice, or that it will be a guide to him? There is a difference. If it is the [570] latter, obviously the Minister has a role; if the former, I wonder whether there will be more duplication. I mention the point about the Minister having the power under section 7 to revoke permission granted. Under what circumstances would the Minister see that arising? Assuming all the foregoing, then one is doing business with a reputable agency and with clear guidelines embarking on a trial. I am slightly worried lest that disincentive would discourage people from becoming involved in drug testing at all.

I was pleased the Minister referred to the need to ensure that the risks to the participant do not outweigh the objectives of the trial; some bizarre scientific and medical research has been carried out, which is sometimes very hard to justify to anybody with a rational mind. That process of weighing the advantages of the trial with the risks involved needs to be regularly reviewed as do the guidelines to be drawn up for the information of the applicants. These should be in clear and simple language. Such guidelines exist at present. I know that consent is necessary for volunteers and that consent forms are shown to people, but there is more than a suggestion that some of these guidelines are, perhaps understandably, written in medical terminology. The problem is that a volunteer in the context of the profile mentioned earlier quite often is not disposed to read such consent forms and in many cases may not understand them. The Minister should interest himself in ensuring that such consent forms are clear, intelligible and genuinely open to being understood by volunteers, as indeed should all information which should be given to them. It should be as comprehensive and as clearly written as possible.

The Minister has referred to the question of payments to participants. This has always been contentious. I do not see anything wrong with the suggestion that people should not lose out financially if they take three weeks off work because they wish to volunteer. That is comparable with the not totally appropriate analogy in the context of jury duty, where [571] this is seen to be a service and we are not expected to lose out in terms of being paid our salaries or wages while serving. It is not unreasonable that a fee should be paid. However, it should not be such that money is the primary aim. Everything is relative, but according to the scale of fees payable at the present time it is a big bonus to an unemployed father of five children in the middle of the city of Dublin. It is not a bonus if one is in gainful employment. That is the problem. Whether one can have a scale of fees to redress the problem I am not sure. That up to now has been part of the tragic profile of the volunteers who have undergone these trials, the advantages of which have been of great benefit to us all.

In summary, I wish the Bill well. It is timely. Up to now the subject matter covered by this Bill has been operated in the context of the declaration of Helsinki. It has operated, by and large, successfully. In a sense in a totally unregulated area as far as the State has been concerned, there has been, so far as one can judge, an extraordinary degree of scientific advance with relatively little apparent medical or social drawbacks, not meaning to underestimate the tragedy of some time back. The time, however, has come to put in place the kind of parameters about which the Minister is talking. They will be of advantage. While there is an advantage to the drug companies, perhaps to the volunteers, perhaps to those who run the drug companies, I stress once again that the advantage primarily is to the community ultimately, to each and every one of us. It is time we paid a little more attention to the moral obligation which each of us has in that respect. It is time we changed the perception of drug trial testing from being something that a small number of people have to do if they have no other way of making a living to being something which each and every one of us has an obligation to assist in so far as possible and to make possible a set of social and employment conditions which will facilitate our participation in that role.

[572] Mr. Howlin: I should like to make a brief contribution on this Bill which has had a long discussion in the other House and to welcome it on behalf of the Labour Party. It was originally piloted through the other House by my colleague, Deputy Barry Desmond, and had a very long, detailed and arduous debate there.

The objective of the Bill is to provide a statutory basis for controlling clinical trials which involve people. There has always been a conflicting demand over which up to now we have not had legislative controls. There is the demand, on the one hand, for more, safer and more effective drugs and medicines. On the other hand, there is the need to ensure that people are not unnecessarily put at risk or damaged by experimentation that is not necessary. The Bill before us proposes a number of changes and controls from the former procedure whereby a particular clinical trial was notified to the National Drugs Advisory Body. That procedure has obvious defects and, indeed, has caused widespread disquiet among the general public whose questioning of the controls exercised or lack of them was noticeable. The new measures outlined and incorporated in the Bill will give reassurance to the general public that a better balance has been struck between the two conflicting demands.

While I have indicated the need for more and safer medicines I should also underline my concern about the plethora of new products, accompanied by massively expensive advertising programmes, which we see introduced on to the commercial markets almost on a weekly basis. They are being introduced by the drug manufacturers, in many instances not for a good medical reason as quite often there already is a list of adequate alternatives available, but for purely commercial reasons, for the drug companies and distributors to make money. That the research for such products should put people, or indeed for that matter animals, at risk is a matter of grave concern and to my mind is a highly questionable proposition. It is clear — and the previous speaker touched upon this — that the area of drug testing is one [573] on which the general public has mixed views. We have been somewhat disdainful of people who have volunteered themselves in what — if we are to look at it realistically — must be a social duty or service in preparing, testing and piloting the ground for products and medicines that will ultimately benefit all of us.

The tragedies which have occurred in this whole area have been referred to already. There was the infamous Thalidomide case of some 25 years ago which shocked the world at the time and copper-fastened the case for adequate advanced testing of all new products before they are commercially licensed. The sad death of a volunteer tester in Dublin last year brought home the need for monitoring and controlling of such tests.

The heart of the new proposal will be the role performed by the National Drug Advisory Board. That board have performed a tremendous service in this country and have an exemplary record. Indeed, they have prevented drugs from becoming available in this country that have proven subsequently not to be in the best interests of the general public. Under the provisions of this Bill that board will have an expanded role. In order for them to fulfil this new role that must be staffed and funded to meet this new demand being made on them. What causes me some concern is the fear that such adequate staffing and funding would not be made available to them in the light of the budgetary difficulties faced by the Exchequer.

I appeal to the Minister for Health to ensure that this area is protected, that the necessary financial resources are made available to staff, and to maintain and indeed expand the service. The obvious implications of any lack of funding in this area are to serious to be underestimated and do not need to be outlined in any great detail. No doubt we shall know very shortly the exact amount of funding that is to be given to the National Drug Advisory Board. I hope it will be adequate to meet not only the role they have performed heretofore but also the onerous additional tasks they will be required to perform in the future. I ask [574] the Minister to reassure the House in this regard.

Many fears have been expressed in relation to the possible impact of the provisions of this Bill, how that might interfere with or stop certain types of research which may be in the public good. Central to that aspect are the ethics committees. They will play a key role in deciding the validity of proposals for clinical trials. It is they who will evaluate and report on the justification for each clinical trial before it is undertaken. I believe the expertise is there to do that. I hope any evaluation done beforehand will be rigorous, scrupulous and that unnecessary and unjustifiable research will not be carried out. We shall have to wait and see how that measure will be implemented in the course of time.

The area of volunteers is also one which has caused great public disquiet. This issue was referred to by the previous speaker. It is quite clear that people must be protected from being forced, for economic reasons, to volunteer themselves for clinical trials. We have been sadly lacking in this regard in the past. I have met individuals who have volunteered themselves for clinical trials in this country without knowing the impact of the particular medicines or drugs they were allowing themselves to imbibe, whose only motive was a financial one, who, because of the economic condition in which they found themselves, felt themselves forced to volunteer. It is clear that the enticement that is legally allowable to companies must not be so great as to be irresistible to those with limited means.

Of course they should also be informed in a very comprehensive way, in layman's language, of the nature of the trial and of the drugs involved so that they may take an informed decision on whether to allow themselves to participate. The Minister's predecessor gave very detailed guarantees in that regard during the passage of the Bill through the other House. I hope those guarantees will be taken on board by the present Minister, that the fears of all the social action groups, those working in the area of the socially disadvantaged [575] — who have very correctly argued that payment for volunteers must not be on a scale that would be simply irresistible to the poor — will be taken into account by the Minister.

Another matter introduced for the first time, a concept of which we may sometimes lose sight, is the need for adequate insurance for individuals who allow themselves to volunteer for clinical trials. It is important that not only the legislative provision should be enacted to require such insurance but that the Minister should go further and have direct discussions with the insurance industry to ensure that such insurance is available. It is quite clear that the insurance industry itself is in somewhat of a flux now and that insurance for public or statutory bodies is becoming not only increasingly expensive but ever harder to acquire. It is my information that insurance in this field might be very difficult to get. I hope the Minister will involve himself in the discussions to ensure that the families and individuals concerned are adequately protected.

The general thrust of the Bill is one which is long overdue, to have some statutory basis for meeting the twin objectives of ensuring that adequate progress is made in the matter of health care products and protecting those who volunteer themselves. This is very welcome.

I share the views expressed that, as a community, we have simply chosen to ignore this whole area. We have accepted that there would be those always there, that people would come forward, in many cases forced by their economic circumstances, to provide themselves as human guinea pigs. The debate in this House and the knock-on discussions that will take place in the country are good. They will force us, as a people, to decide whether we want more and more testing to continue, whether we should restrict testing to areas of provable good to the general public and whether the whole range of new products being introduced for commerical reasons are justified at [576] all. I look forward to debating on Committee Stage the detailed sections of this Bill with a view to modifying sections which can be strengthened and I wish the passage of the Bill every success.

Proinsias De Rossa: I, like all Deputies so far, welcome the introduction of this Bill, although I have serious reservations about a number of aspects of it. There is no doubt that it is long overdue and that it would probably never have seen the light of day but for the unfortunate death of Mr. Niall Rush in 1984. Before that time few people in this country realised that there were clinical trials of this nature being carried out within the State. Although it has taken two years since the death of Mr. Niall Rush to bring in this legislation at least we have advanced somewhat and the State are accepting their responsibility to have mandatory control of these tests.

It should be clear that when we are discussing these so called institutes, we are discussing fairly major profit-making companies. In the nature of things private companies are in the business of making money. It is necessary to have statutory control of these organisations where the tendency is always to cut corners so as to make more money. It should also be borne in mind that while these institutes carry out important work in testing useful drugs, they spend a lot of their time testing drugs which are only commercial variants of drugs already on the market. The World Health Organisation estimate that there are 15,000 commercial drugs on the market in the western world at present and that a basic 300 drugs would be sufficient to cover most medical eventualities. Clearly, there is a huge potential for the drug companies. Obviously there is a market for them or the drug companies would not produce them in such large quantities and would not spend such large amounts of money in developing new variations. In many cases all they do is change the colour, size or shape of the drug. It is right that all drugs should be tested before they are launched on the public.

An indication of the kind of money [577] involved in these drug testing companies can be seen from the figures I now give. The Institute of Clinical Pharmacology is perhaps one of the most profitable companies operating in Ireland. Following their floatation on the US Stock Exchange in 1985, they are now estimated to be worth more than £45 million. In 1984 they made a profit of £1.37 million on a turnover of £3.8 million. That is a huge profit on a relatively small turnover. The chief executive of the company in 1984 had a personal income from the institute of over £500,000 and his own share of the company is worth around £27 million. I make these points to highlight the fact that we are not talking about companies with a purely humane interest in the development of new drugs to treat the diseases of mankind but about companies who have spotted a gap in the market. The drug companies regard the testing of drugs as a fairly high risk busines and are prepared to pay fairly large amounts of money to have their drugs tested. Various people have seen this as a money spinner and have become involved in it. The tragic death of Mr. Niall Rush raised in the consciousness of the people of this State the reality of what was going on here and the fact that until this Bill is passed the controls on these trials are voluntarily complied with.

The other main company involved in drug testing in the Republic of Ireland is the Elan Corporation which has a 24 bed clinical pharmacology unit in Athlone. They also have a successful business record. According to the Irish Independent of 13 January 1986 the founder of the corporation Mr. Donald Panoz turned an investment of just $50,000 into $50, million in just 17 years.

While many of the trials undertaken are important for the development of new drugs, many are developed just to make profits. One hopes that these companies are involved in developing drugs to combat the AIDS epidemic which this and other countries are facing at present. No doubt that will be a big money spinner. Private companies, it must be remembered have the primary aim to show a good profit on the balance sheet [578] at the end of the year and they must be controlled to protect the health of people who will submit themselves for trials and the general public who will have to use the drugs. There must be statutory controls to ensure that these companies are carrying out their function in the best interest of the public.

In September 1984 Mr. Niall Rush unfortunately died as a result of complications from a drug test programme. In September 1984 the inquest was held and the Dublin City Coroner, Professor P.J. Boffin, explained to the jury that as well as the ordinary findings concerning identity and cause of death, they were entitled to add a rider to alert the public and the authorities so that the same type of incident could be prevented in future. Having heard comprehensive evidence and detailed submissions the jury added a lengthy rider suggesting that the testing body should always obtain the full medical history of each volunteer from his or her local doctor, that each phase of testing should be preceded and followed by a full medical examination and that results of the examination should be obtained before the first phase of testing, that the testing body should ensure that each volunteer is fully aware of the risks involved, that the legislation be forwarded to the committee for the harmonisation of the laws of the Council of Europe, and that an independent body involving the Department of Health be set up immediately to examine recruitment of volunteers, screening of volunteers and security and safety procedures of the company where the death occurred. This Bill goes some way towards implementing those recommendations, although I have reservations in a number of areas.

My first reservation is whether it is desirable to have payment for volunteers to participate in these trials. No matter what restrictions are brought in, the temptation will always be for those who are poorest in society to avail of whatever inducements are available. The gap in the Bill is that there is no specific statement as to how the inducements will be con-there [579] trolled or restricted. It is said that the ethics committee will have regard to the question of what inducements are being offered, but it is not said that they will be restricted in any way. In his speech the Minister mentioned that he would have regard to this, but it is up to the Minister of the day to decide whether he will allow particular inducements. I feel strongly that the questions of inducements should be ruled out altogether.

While the Blood Transfusion Service is not directly comparable to clinical trials for obvious reasons — there is no risk involved in blood transfusions — the reality is that we have a voluntary system of blood transfusion servicing where people who provide blood do not get any inducements, except a cup of tea and a biscuit. This is an example of the response one can get from people provided it is shown that the risks are minimal and is one reason the procedures being adopted by the clinics are tested and guaranteed to the last degree.

There is also the question of recruitment of volunteers. There is evidence available from various groups dealing with the homeless, with people who find themselves in difficult circumstances, drug addicts and so on, who have been recruited to participate in clinical trials. I refer the Minister to a document issued by the Social Policy Action Group, Post Office Box 1447, James' Street, Dublin 8. They give case histories of people who were recruited for drug trials. These people could not be claimed to be in a position to give a voluntary and informed consent to the trials. One person was a drug addict who needed money to feed the habit. The claim in this document is that while that person was involved in the drug trial he actually got supplies of heroin, presumably from persons outside the organisation carrying out the trial. By no stretch of the imagination could this person be regarded as being in a position to give free and informed consent to participate in that trial.

Another person was under a lot of pressure from money lenders and in order to get some money together participated [580] in drug trials. A homeless person living in a hostel was recruited in the hostel and the person who recruited him was paid for doing so. In turn the person who was recruited, recruited others and was paid for it. This question of volunteers who are under pressure, financial or otherwise, or who, because of their circumstances, and the nature of the lives they lead are homeless, orphans and so on, are not in a position to comprehend fully what they are getting involved in, is not covered adequately in the Bill, and I hope during Committee Stage we will deal with this in more detail.

The crucial point in relation to any person volunteering for a drugs trial is that there must be free consent, and it must be informed consent. I understand the World Health Organisation published guidelines in 1982 which stated that the involvement of human subjects in biomedical research must be contingent, wherever possible, upon freely-elicited, informed consent and upon liberty to withhold or withdraw collaboration at any stage without fear or prejudice. They went on to say that no alternative basis existed for protecting effectively the freedom of choice of the individual and ensuring that such research finds acceptance with opinion at large. In my view, the Bill before us does not deal adequately with that area and does not provide the kind of protection and safeguards which people who are vulnerable need to ensure that they are not at risk.

Another area which is of concern to me is the ethics committee. Although this is not spelt out in the Bill, in his speech the Minister said the Minister would approve the ethics committee submitted by the clinic on the basis of guidelines which would be drawn up for the information of applicants so that they would know what the Minister might be expected to approve of in terms of the composition of such committees. He went on to say:

I am sure that all involved in the conduct of clinical trials will accept that the public have a right to feel satisfied not only in regard to the competence [581] but also to the independence of these committees.

There is no indication in the Bill what these guidelines will be or how the Minister will ensure that the public are satisfied that the ethics committees are independent or competent.

Whatever about the competence of the committees, I cannot understand how the Minister can expect the public to accept that, when these companies appoint ethics committees of which he will approve under certain guidelines, which we do not yet have and which are not included in the Bill, they are independent committees. It would be better if the Minister took the power to appoint and dismiss where necessary ethics committees in relation to these trials. Admittedly there is no reason why he should not take advice from the companies involved because there may be specialist trials which would require specialist competence, but I believe the Minister should have the power to appoint and dismiss the ethics committees. That is a point we will press on Committee Stage. Above all, the public, as the Minister admits in his speech, must be assured that the committees that will make the decision whether trials should go ahead or not should be independent and be seen to be independent. There is no way that can be done by retaining the position as it is whereby the clinics themselves appoint the committees.

There is one further point in relation to the committees which puzzles me. Perhaps, it is because I have not grasped it in the Bill and the Minister may well be able to explain it. The Minister in his speech talked about the committees supervising the clinical trials but I can find no specific reference in the Bill to the power of the ethics committees to supervise trials. They have the power to sanction them. The Minister has the power to send someone in to a clinic to inspect it and to ensure that everything is being done in order but I can see no reference in the Bill to the fact that the ethics committees will have the power to supervise. Perhaps, the Minister will [582] clarify that point and show where the power lies for supervision.

Basically, that is the position of The Workers' Party in relation to the Bill. We are pleased it has been brought forward. We know a lot of work has already been done on it in the Seanad. As I say, we have reservations about the formation of the ethics committees and on the payment and recruitment of volunteers. I hope to be able to deal with those matters on Committee Stage.

An Leas-Cheann Comhairle: I am calling Deputy Abbot. I might indicate that if the Deputy had risen earlier on he might have been called sooner. I welcome him to address the House in his maiden speech.

Mr. Abbott: I am obliged to you for your courtesy. Let me digress a moment to congratulate you on your appointment to the high office of Leas-Cheann Comhairle. I wish you every happiness and success and a long tenure of office. I want to assure you of my personal co-operation and if on some occasions I falter you can put that down to the fact that I am gaining parliamentary experience as the days go by. I also want to take this opportunity to congratulate the Minister, Deputy O'Hanlon, and his Minister of State, Deputy Leyden, on being appointed to their offices. I wish to offer them my fullest co-operation. I am a neighbouring Deputy to the Minister of State, Deputy Leyden. I wish them the height of success and a long tenure of office.

I want to fully support this Bill. It fills a very real need in our society to ensure proper control in the carrying out of clinical and pharmacological trials. The work carried out by the Seanad has been alluded to by previous speakers and I, too, would like to compliment the Members of the Seanad who were involved in the debate, together with the former Minister for Health, Deputy Barry Desmond, for the manner in which a consensus was reached in relation to the various matters in the debate.

I would add my voice to the opinions already expressed that those who challenge [583] the role of the Seanad should read the debates of the Seanad to see how useful a body and institution the Seanad is and can be in regard to the processing of legislation and in ensuring a consensus in relation to legislation in new areas of activity. We are dealing with a new area about which the public did not have a great concern until certain tragic events came to light. These have been alluded to already and I will not elaborate. Suffice it to say the public now have great concern about the orderly development and regulation of clinical trials. It is to meet this public concern that this legislation is being brought forward and I congratulate those who have worked on it.

Let me say with some temerity, given that I have not studied these matters, that it might be a precedent to see one Minister congratulating a member of the Opposition for the contribution he made to the Bill in the Seanad. I allude to the fact that Deputy Desmond while Minister for Health congratulated Senator Fallon, my colleague in County Westmeath, for his contribution when he spoke on Report Stage of the Bill in the Seanad. It was heartening to see Senator Fallon being congratulated by the new Minister for Health, Deputy O'Hanlon, for that contribution also. I want to say how proud I am to be a fellow county man of Senator Fallon and to see how he has gone about his work, together with the other Senators who made very substantial contributions. In reading the debates of the Seanad one realises the value of bringing together persons of different backgrounds, commitment and training to bear on a complex matter such as this Bill before the House.

In the cut and thrust of the debate there was a generosity flowing from all sides as to how the amendments should be dealt with. It is heartening to see that in the progress of the debate minds were opened and changed and eventually a consensus was reached. People were not committed to preconceived ideas. They were prepared to debate and allow the Seanad to involve itself in the creative process of developing the very best and [584] optimum solution. I am satisfied that the Bill as now presented does present the optimum solution in the framing of the legislation to strike a balance, as has been referred to by other speakers. The Bill will ensure that clinical trials can progress and that the very substantial contribution to the economy which is made by the conducting of clinical trials in various parts of the country can continue while, at the same time, protecting the safety and welfare of the volunteers. It will ensure that the consent they give to the conducting of the trials is an informed and genuine consent and that during the trials that consent remains informed. That is a crucial matter in the carrying out of the trials.

In relation to the Bill itself, the matters of very grave concern are initially, the matters of definition. I do not propose to go into that question because it was dealt with in great detail in the Seanad. Great care was taken in that House to establish definitions in regard to clinical trials and the functions of the ethics committees, the bedrock of the legislation. It is necessary if a proper controlling mechanism is to be established that clinical trials are clearly defined so that ambiguities will not arise at a later stage. It is important that our courts are not left in an ambiguous position if they are asked to interpret the provisions of the legislation.

In general those who are carrying on clinical trials are co-operative and I hope that co-operation between those parties and the Minister for Health will continue following the introduction of the legislation. I hope our courts are not asked to adjudicate on whether an offence has been committed under the provisions of the Bill. A company in my constituency, the Elan Corporation of Athlone, are very involved in clinical trials. The contribution of that company to the economy of south Westmeath is substantial with 120 people employed there. International and domestic contacts of the company book 1,200 bed nights in local hotels annually. That represents a significant contribution to the hotel industry. Many volunteers come from the local area and their safety is of paramount importance [585] to me. It is important that any Member who has such a company operating in his or her constituency should take into consideration the health of volunteers. A balance must be struck between local prosperity and the safety of constituents who offer themselves as volunteers.

I accept that the manufacture of drugs must continue and that it is important that medical research continues. That work should never be underestimated. We may have to contend with some advertising techniques in regard to the manufacture of drugs. There is a lot of commercialisation in regard to the sale of certain medical products and unnecessary duplication but we must not underestimate the importance of the commercial sector in regard to medical research. It is important that research companies have sufficient funds to continue their work. When one thinks of the AIDS scare and viruses that are common nowadays one appreciates the importance of the continuation of medical research. Drugs that proved effective in dealing with some complaints down the years are no longer adequate to deal with modern ailments. Drug manufacturers are engaged in a constant battle to combat viruses. It appears that as time goes on bacteria develop resistance to drugs. Clinical testing should continue but there should be restrictions.

I understand that the Bill deals with drugs in respect of which there was an authorisation under the Medical Preparations (Licensing, Advertisement and Sale) Regulations, 1984. The Bill was modified to permit tests on drugs authorised under those regulations to proceed without the need to make a formal application. That is a welcome development in that it ensures greater flexibility in testing in that area. It is important that the Minister continues to monitor this matter because changes may be necessary later. Section 2 (2) should be retained. The restriction in regard to clinical tests being carried out is satisfactory but the Minister should bear in mind that some people may set up trials that we would [586] not condone. It is important that that provision is not abused.

The provisions drug companies must comply with in regard to clinical tests are dealt with in section 3. It is very important for people in the field of drug testing to know what they are facing when making an application to undertake a clinical trial. Applicants should provide 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. The National Drugs Advisory Board have been introduced as a participating body in relation to the implementation of this legislation. That is important because they represent the very highest authority in the various fields attached to the evaluation of drug testing. The participation of the National Drugs Advisory Board can also be seen as an effort to ensure that there will not be duplication of scarce resources in relation to the scientific assessment of the various applications for clinical trials and on assessment of the drugs to be used.

The Minister should make regulations under section 17 which would reflect the clear dictates of section 3 in relation to information to be supplied by the applicant. They should not put any great onus on applicants to engage in any great expense in the provision of documents and materials which do not go towards furthering the objectives of the legislation.

The question of the granting or refusal of permission to undertake a clinical trial is dealt with in section 4. There is a time limit of 12 weeks during which an application has either to be granted, or refused, or granted subject to modifications. Perhaps the Minister will clarify what happens if no decision is made after the 12 week period. It would appear that after the 12 week period a decision to grant or refuse permission by the Minister might not be soundly based in law. It could be said that the Department of Health and the Minister would never exceed the 12 week period, but in case [587] there is human error and mistakes are made I mention the point.

Under section 3 (1) (h) the appropriate fee, if any, must be paid with the application. If the procedure is to be self-financing the payment of fees will form a significant part of the procedure and it would appear that they will be significant. If the 12 week period elapses and no decision is made, will the applicant have to pay another fee? Will there be any departmental or ministerial responsibility for the loss of the first fee? I am confident that the efficiency of the Department of Health and of the Minister will ensure that this does not happen but I mention it to alert them to the implications of the 12 week period.

I am confident that the Minister and the Department, with the assistance of the National Drugs Advisory Board, will deal fairly and efficiently with all the interests involved — the drug companies, the public and the volunteers. Having regard to the fact that the drug companies contribute significantly to the economy and to local economies wherever their undertakings are situated, it is important that the Minister should ensure that not too many bureaucratic obstacles are put in their way and that the companies are alerted to any misgivings or forebodings the Minister may have to give them a chance to mend their hand and comply with the legislation in full.

Section 5 deals with the amendment of permission to undertake a clinical trial. It ensures that there is a controlling process in relation to the conduct of the clinical trial. The Minister has power to inspect the premises and the records of the company carrying out the trials. He is enabled to act on the information received by him through the inspectorate to be set up under the Bill. Thus clinical trials which start on a good footing can be changed, modified and amended to allow new circumstances to be taken into consideration and the experience of the clinical trial as notified to the Minister through the information available can be used to ensure that a proper check is kept on the trials as they go through.

[588] In relation to the revocation of permission to undertake a clinical trial, this may be important having regard to the review process which is implicit in the Bill, the information gathering process signified by the Bill and the other modified powers of the Minister. The revocation of a permission will obviously not be undertaken lightly by the Minister. Various contributors and commentators in relation to the legislation have voiced disquiet that perhaps permission to undertake clinical trials would be revoked without reason or warning. I do not share that view because Ministers will have to work within the ordinary context of the rules of natural justice. In the past the courts indicated — and continue to do so — the requirements and standards by which Ministers and people in positions of quasi-judicial authority must act. I am satisfied that, if these criteria are applied, no persons seeking permission to undertake a clinical trial and going about their business in a proper and orderly fashion should have any worries that the permission would be revoked in a capricious or underhand manner.

The question of notification of intention to revoke should be considered by the Minister before there is a revocation and unless there are drastic circumstances or an emergency, permission should not be revoked unless there were clear indications by way of written notice or at least verbal warnings to the person carrying out the clinical trial that the question of revocation of permission was being considered by the Minister. It will be noted that the Minister in any event, by the express provisions of section 7, must notify the person undertaking the clinical trial of the reason for his revocation of the permission. I envisage that this power will be invoked in exceptional circumstances. All those involved in clinical trials or who might become involved in the future should be aware of the fairly sweeping powers of the Minister to revoke permission to undertake clinical trials. Perhaps they will operate in such a way that that power will never have to be invoked.

The inclusion of the ethies committees [589] in the structure for the examination and surveillance of clinical trials is a very important and democratic input to ensure that such trials proceed, having regard to the requirements of public interest and the criteria set out in the legislation. The Bill gives a good deal of freedom in relation to the composition and terms of reference of the ethics committees. It is very clear that the ethics committees will be independent bodies composed of persons of wide-ranging experience who can be depended upon by the Minister to tell him if the clinical test is justified in the circumstances. I am satisfied that the legislation caters for the need to have this objective surveillance of the clinical test procedure and, at the same time, allow for the degree of flexibility which will be so necessary to encourage enterprise and investment in relation to this area.

It is all very well to say the Minister can interfere in the composition of ethics committees and can dictate at the outset their composition — the Minister has the power of veto in relation to ethics committees — but there will be criteria involved on the part of the commercial drug tester also which will include the suitability of persons involved in the ethics committees from the point of view of retaining commercial confidence on the part of the drugs company involved. It is important that the freedom of the body carrying out the clinical test is recognised in the legislation. If the person carrying out the clinical test is subjected to surveillance by an ethical committee which is antagonistic to the interests of the company, the company involved might well stop production and activities within this jurisdiction. We must be sensitive to the fact that the freedom contained in the Bill in relation to ethics committees will continue, regardless of whatever minor and technical amendments are made in relation to the operation of the ethics committees.

The Bill is specific in relation to the criteria which must be met by the participants in clinical trials. Section 9 deals with this matter and it is important to realise that, even as things stand, the courts provide in each individual case [590] certain protection for any person engaging in a clinical trial. The courts have always applied the code of equity to ensure that a person in an inferior bargaining position, either through lack of resources, mental ability or information, is not exploited by someone in a far superior bargaining position. A person of no medical training, little means and possibly under some pressure because of economic circumstances who would perhaps undergo a clinical trial for the purpose of gaining recompense instead of volunteering to ensure the development of medical knowledge, might well be in a position where the court would protect him or her against the insistence of any person seeking to compel them to continue with the medical trial. The courts would ensure that they could not be so compelled. The legislation proposed in the Bill in section 9 (6) puts this proposition beyond doubt and that is very welcome. It provides that:

Any person who has given his consent in accordance with this section may withdraw it at any time and no contractual liability shall be incurred by such person from such withdrawal.

It is important that this be stated notwithstanding that it may be a statement of the factual situation with a large number of volunteers involved in medical and clinical testing.

The question of consent is paramount in relation to the qualification of participants in a clinical trial under this legislation. One cannot be glib about consent. At present consent to clinical trials is necessary in this country. It seems that in general the consent is an informed one and that persons are advised in relation to the risks involved in their undertaking of a clinical trial. The legislation envisages that this type of information would continue to be supplied to participants. At the same time, the legislation recognises that in the ordinary working day, while volunteers can be supplied with information in relation to the risks of discomfort, the manner in which the drugs are to be administered, and the objectives of the trial, in many cases the [591] volunteers may not appreciate what is told to them and the exact circumstances and consequences of the clinical trial. It is to cater for that situation that provisions relating to the right to withdraw from the clinical trial are so important. I would like to think that any person volunteering for clinical trials under the supervision of this code of legislation would be made fully aware of his or her right to withdraw consent at any time.

In relation to the matters which should be told to the person about to engage in and to volunteer for the clinical trial, one matter of some concern to me is the requirement that the risks and any discomfort involved in and the possible side-effects of the trial should be notified to the volunteer. The risks in any clinical trial involve first that of physical discomfort and injury. Secondly, the risks are not being compensated in respect of discomfort and physical injury suffered by the volunteer, obviously, the legislation envisages that some recompense would be given to volunteers and in general where the clinical trial is a benign, successful clinical trial involving no significant discomfort, damage or injury to the person, then that recompense is clearly sufficient for that person. However, I think persons will volunteer for clinical trials on occasion who will suffer injury, notwithstanding the warnings of the risks and discomfort which they will suffer.

It is a matter of grave responsibility for the ethics committees and for the Minister to ensure that persons are not exposed to any significant risks of personal injury arising from clinical trials unless steps are taken to make it very clear to them that they are running very high risks. One knows of the tendency to ignore the fine print in any type of contractual arrangement and it is always in the fine print that one finds the exclusion clauses and warnings of damage or injury which may be suffered and in respect of which no compensation may be paid. I consider that there is a risk that volunteers entering into arrangements to have clinical trials carried out would have [592] the impression that if they suffered injury they would be covered by insurance because there is a provision in the Bill that insurance be provided. Section 10 refers to that point. There is an impression at large that this insurance might be a of no-fault type of insurance and that if any injury of a serious nature resulted from a clinical trial the volunteer would have the fall-back position of compensation for that injury. I do not interpret the legislation in that way. I think that any insurance company involved would have regard to the fact that the contract between the volunteer and the clinical tester or drug company is essentially one based on the consent of the volunteer to any injury which may be substained by him as a result of the trial to which he had consented and which has been notified to him clearly.

The courts, having regard to the manner in which they have dealt with the emergence of the common law relating to industrial accidents and the element of consent of a worker to be involved in dangerous activities, would guard jealously the rights of the volunteer in this situation. Nevertheless, the volunteer in certain circumstances, having regard to the thoroughness of his consent and the view of the courts of the thoroughness of that consent, could end up by suffering significant injury. Yet, he might not be compensated. The liability of any insurer involved under an insurance policy to which section 10 might relate would relate only to the liability of the person applying for the clinical test and carrying on the clinical test arising from possible negligence or fraud on the part of that person in securing the consent of the volunteer in the first instance, or negligence or fraud in the carrying out of the clinical test. Therefore, the clinical test would go outside the strict terms of the consent of the volunteer as it might be interpreted by the courts, having regard to the fairly liberal approach of the courts to these matters in favour of the volunteer at present. This is a risk, I suggest, about which the volunteers should be warned. It is a complex matter and I wonder how [593] it might be best dealt with at the level of the operation of the clinical test itself.

I would like the Minister to have regard to my comments in relation to that aspect so that the volunteers are fully appraised of just exactly the risks involved, not only the medical and physical risks but the legal risks also. Volunteers should be advised also that if they suffer unforeseen damage or injury going outside the terms of their consent as a result of some culpable act on the part of the person or body carrying out a clinical test on them, they have recourse to the courts to vindicate that right in certain instances if the insurance company or the person carrying on the clinical test is not willing to compensate them immediately.

I am only too aware that, notwithstanding obligations on the part of persons to compensate others in respect of injuries, one finds that there is a procedure which is almost always adhered to, that is to compel the person injured to seek a remedy in the courts and to press the matter up to a certain stage in the courts at great expense and trouble. Ultimately perhaps the person obliged to compensate and the insurance company obliged to indemnify that person will pay, but there is a very traumatic interval during which the injured person, which might be a volunteer in this instance, must process a claim and must go through the trauma and worry of wondering whether the claim will be sustained or not. I hope no such claims will ever arise. It is a real possibility that they will arise from time to time, perhaps not through the great fault of anyone but nevertheless through negligence and this would give rise to a legal liability. It is important that we ensure that the volunteers would be alerted to these difficulties and dangers. Above all they should not be given the impression that the intention and the substance of this legislation is to give a no-fault type insurance in respect of all eventualities arising from the participation in clinical tests.

In relation to the surveillance of the procedures to be carried out under the terms of the legislation it is important that [594] the Minister should, in the regulations envisaged in section 17 in regard to the provision of information and the keeping of records, make suitable provisions to ensure that all information which is necessary to him would be available from the persons carrying out clinical tests. There is a need to safeguard against undue interference with the day-to-day operation of these clinical tests. Nevertheless, unless proper procedures are set up for the retaining of records, then the Minister's job of controlling the operation of clinical tests under this legislation will be a very difficult one. This is an area where another balance must be struck between, on the one hand, the needs of keeping a good record and keeping up a bureaucratic structure and, on the other hand, maintaining the functioning of the clinical tests and ensuring that the economic activity which underlies these tests and the expansion which may be within the capabilities of the various bodies carrying on the economic activity through the carrying out of clinical tests, will not be impeded.

The fact that this code of legislation and its implementation by the Department of Health will be self-financing is to be welcomed. There is no reason why companies making a good profit from the carrying out of clinical tests should expect the taxpayer to bear the cost of these surveillance procedures. The possibility of further legislation in this area does not arise at this stage. I hope the Bill will be passed as quickly as possible. The benefit to the public, to the volunteers and to the companies will be enormous if this legislation is passed. The benefit to the companies is obvious. If they can say to the world at large that their products are tested within the framework of a very rational and tightly controlled system of surveillance by a responsible Government Department, then the validity of their testing procedure will be all the greater and the appeal of their products on the world market and the domestic market will be all the greater too. On that basis I hope there will be as much expedition in the passing of this Bill subject [595] to whatever contribution might be made on the Committee and other Stages.

An Ceann Comhairle: Deputy Brian Swift.

Mr. Desmond: Sorry, a Cheann Comhairle——

An Ceann Comhairle: For the benefit of Deputy Desmond the Chair has already called four Opposition speakers one after the other. The Chair feels an obligation to maintain a certain balance in respect of Government Deputies and consequently is now calling on Deputy Swift.

Mr. Desmond: Surely, a Cheann Comhairle, it is a long-established precedent of the House that a Government speaker is followed by an Opposition speaker who offers.

An Ceann Comhairle: I have already informed the Deputy and indeed he was here this morning and witnessed that at some stage. I called the spokesmen for the Opposition parties in the House one after the other to the exclusion of the Government Deputies. I now feel that that kind of imbalance must be rectified and I am doing so. Deputy Swift.

Mr. Swift: In view of Deputy Desmond's previous office I am prepared to let him speak now if he wishes.

Mr. Desmond: I will decline to speak now.

An Ceann Comhairle: That is very magnanimous.

Mr. Swift: Déanaim comhghairdeas leat, a Cheann Comhairle, as ucht an ard oifig atá bainte amach agat. Ar ndóigh déanaim comhghairdeas chomh maith leis an Aire agus leis an Aire Stáit. A Cheann Comhairle, I am very grateful to you for the opportunity to speak at this point. I congratulate you, and also the [596] Minister and the Minister of State, on the offices you and they have obtained. I wish you well for the duration of this Dáil and I hope, like the rest of us here, that it lasts for some time. I would like to compliment the Minister for Health for bringing this very necessary and desirable Bill before the Dáil and also the former Minister, Deputy Desmond, for bringing the Bill before the Seanad in the first instance. The Bill contains 57 or 58 amendments. I agree with other speakers that that indicates, first, an openness on the part of the previous Minister to criticism and suggestion. It also portrays the Seanad in perhaps a better light than it is portrayed at the moment by the media. Perhaps it portrays it in the light in which it should be portrayed, which is of a constructive, useful assembly.

My few comments will relate in broad outline to support for the general measures in the Bill, with one or two queries and reservations which I hope the Minister later on, or indeed any other speaker, may be able to answer and satisfy me on. In the first instance, there was a great need for this Bill to be brought before the Houses of the Oireachtas. It seems that there had been an appalling lack of control of clinical trials in this country heretofore. I do not say that necessarily in a sense critical of those conducting the trials because the onus for bringing forward legislation rests not on them but on the Members of these Houses. Whatever the reason, there was a great need for control. In large measure, the Control of Clinical Trials Bill will achieve the degree of control and regulation which is necessary.

One of the main reasons for needing the Bill has been the fact that it is the vulnerable elements in society who are normally the participants in these trials. I am thinking, in particular, about the unemployed people, possibly deserted wives, or people on low incomes and students in our institutes of higher education. To protect them, this Bill was very necessary. Deputy Michael Keating said that perhaps there was a moral responsibility on the community at large to take part in clinical trials. I do not [597] know how serious he was in making that suggestion, but if he was serious, I for one would be totally, utterly and absolutely in disagreement with him. I do not think that there should be the slightest element of compulsion on those taking part in clinical trials, whether that compulsion be legal or, indeed, some spurious form of moral compulsion. If I could take a rather extreme example, I certainly would not like to be the legislator urging the general public to take part in some form of clinical testing in relation to the AIDS disease which is so much spoken about at the moment. Perhaps Deputy Keating might like to comment on that at some future date.

On the question of payment to those taking part in those trials, I welcome the provision in the Bill which says the method and amount of payment must be specified. Some Members have had reservations about the fact that there should be a payment at all. In the real world in which we live it is not realistic to expect people to take part in these trials without some form of payment. As far as I am concerned, if the proper circumstances obtain and the provisions in the Bill are respected, and if the people want to be paid and the companies are willing to pay them, let that be so. It is right that the question of payment should be addressed in an open way, that it should be referred to in the Bill and that the company should have to specify the amount of payment in their submissions to the Minister.

Paragraphs (f) and (g) of section 8 (4) stipulate that the extent and nature of the examination must be specified and the health of the participants monitored before, during and after the trial. That is an extremely necessary provision, one which is very worth while. Again, I am glad it is specified in the Bill. It helps to establish a good motivation for the companies conducting the trial. It will be seen that the participants are being cared for. It is a provision which will give a great reassurance to the general public.

On the question of the regulating authority, like other speakers I am glad the National Drugs Advisory Board have [598] now been brought into the Bill; initially they were left out. They are now very firmly in place within the sections of the Bill and that is a good thing. However, I should like to make one or two points in that regard. It is essential that the regulating authority must be able to respond quickly to any applications that come before it, both on the question of the time scale and of staffing.

In relation to the time scale, that is specified quite clearly as 12 weeks, but if a query arises I understand that time scale lapses until the query has been dealt with. Furthermore, there is no time scale on the ethics committees in which to make decisions. While I appreciate the difficulties involved and that an ethics committee is something in the nature of an in-house committee for those conducting the trial, as a general view it is the desire of all concerned that decisions should be made quickly and the process always expedited, subject to proper standards of care and safety as provided for in the Bill.

Another reason which I do not think has been adverted to here this morning for this Bill being so essential and desirable is that there are so many drugs on the market at the moment or coming on the market, with so many unknown side effects, many of them coming from abroad. I understand there are very few companies manufacturing in Ireland whose products are sold directly on to the Irish market. In one shape or other, many of our drugs come from abroad where we would have no control, either as a community at large or as legislators. It is extremely important that this Bill has come before the Dáil because it gives this Legislature a certain measure of control over the products of companies from foreign countries which we did not have up to now. Bearing in mind that those products could be coming from a host of different nations with varying degrees of standards relating to their production process, that is to be welcomed.

Again, I do not think the question of the regulating authority responding quickly in terms of staff has been adverted to up to now. I wish to place on record my concern that the National [599] Drugs Advisory Board should receive proper staffing and facilities to cope with what must surely be an increased workload after this Bill becomes law. I do not think there is any doubt that it will become law. There will be a need for more staff for the board and more facilities. In an age in which we are talking about all sorts of cutbacks, if we are to pass this Bill in this House we must honestly and openly say this board will need an increased number of staff, no matter what other cutbacks or paring down we may make in other areas.

With regard to the question of compensation and insurance, like Deputy Abbott, I am glad to note that the question of insurance is covered in the Bill. However I do have one or two reservations about that provision. I refer now to section 10. So far as I can ascertain there is no reference in the Bill, in section 10 or in any other section, to insurance. There appears to be no hard and fast rule in the provisions of this Bill that the insurance policy must be produced to the Department or to the board before a clinical trial is sanctioned. I consider that to be a deficiency in the Bill but perhaps the Minister would consider rectifying that deficiency.

Section 10 (2) says:

It shall be a good defence for a person prosecuted for contravening subsection (1) to show that he reasonably believed that the provisions of that subsection had been complied with.

I would have reservations about that provision because it seems to me to be based almost entirely on the provisions of the Road Traffic Act relating to motor insurance. Here we are dealing with a potentially much more serious problem than that of motor insurance. I see no reason that that should constitute a good defence or, if it is a good defence, that it should constitute an absolute defence. Rather could it not simply be regarded as constituting a mitigating factor in any defence put forward by a company conducting a trial? I would have reservations about section 10 (1) and (2). I would [600] appreciate hearing what the Minister may have to say about them. If I am correct in what I am saying perhaps he would consider taking my suggestions on board.

Section 9 (7) is the subsection dealing with the question of consent, whether a person is capable of understanding the nature of the relevant trial and so on. In a decade in which there has been so much discussion, much of it very controversial, about the supremacy of the family and so on, I do not understand why parents or guardians are not mentioned in subsection (7) (b). Where an individual may be incapable of comprehending the implications of a test I would prefer that a parent or guardian be always present or their consent always sought. I should like to see them specifically mentioned in the provisions of the Bill. There may be cases in which a parent or parents may be deceased or whatever. Nonetheless I should like parents or guardians to be mentioned and, if there are other relevant circumstances, they can be covered also under the provisions of this subsection.

It appears to me, on a reading of section 11, that there is no positive duty to furnish the results of tests unless the Minister makes a specific request. On the passing of this Bill or at some future date would it not be a good idea that it would be automatic and obligatory to furnish the result of any such test to the Department, that there be a special division within the Department assigned to keep such results on record? Would this not be good from the point of view of the Department themselves by way of monitoring the performance of various companies conducting such tests, of the people taking part in them or general practitioners or medical advisors who might subsequently want to refer to such records? There should be a positive, specific duty on companies to supply the results of tests to the Minister or his Department, with a register maintained for future reference.

With regard to section 14, particularly when one is dealing with powerful, large multi-national companies which at times can frustrate the course of justice and [601] investigation, not merely by individuals but by powerful organisations, there should be greater safeguards included in the provisions. There was a famous case involving the Hoffman La Roche company some years ago, when they frustrated for years the efforts of an individual and subsequently of the offices of the EC itself to investigate their affairs in relation to particular drugs in an event involving a subject of Great Britain. Great attention should be devoted to establishing the principle of placing the onus of proof on such companies, but also affording greater investigative powers to officials of the Department of Health. This would mean that the regulation and monitoring of clinical trials will not constitute merely sweet meaningless words but will ensure that the monitoring process will have real teeth with which to dig into the affairs of companies which may or may not be co-operating in full with the Department.

Those are my general comments. I welcome the provisions of the Bill in broad measure. I do foresee its provisions having a non-drug side effect, in that if we become proficient in this areas, establishing our credentials internationally, then there will be a possible benefit to this country through gaining investment from companies being attracted from abroad, who would establish themselves here for testing and manufacturing purposes. However, that is very much a side issue. The main issue relates to the control of clinical trials, the protection of our people, particularly those who may participate in such trials, people with a deprived background or subject to financial stress who might engage in such trials to get themselves out of financial difficulty. I believe the provisions of this Bill will now afford them the protection lacking to date.

It is my belief that the industry and those involved in the companies conducting these clinical trials will welcome the enactment of the Bill because it will lay down guidelines for them on which to base their future conduct, something denied them to date. This is a welcome Bill. I should like to see my reservations [602] taken on board by the Minister. If they are unfounded, so be it. However, if there are good grounds for such reservations then I would ask the Minister to take my suggestions on board. I compliment the Minister, his Minister of State, the staff of the Department of Health and indeed the Minister's predecessor on his initiative in bringing forward this Bill.

Mr. Desmond: I thank Deputy O'Hanlon, Minister for Health, for his gracious comments in respect of my role in bringing forward this legislation. I wish him well in his very difficult office, and I wish Deputy Leyden well as Minister of State in the Department of Health. I also thank the officers at many levels in the Department of Health who had the exceptionally difficult job of drafting this legislation and had the onerous task of preparing a memorandum for the Government outlining the rationale behind each of the sections. This was exceptionally difficult work because in the UK, throughout the European Community, and for the most part in the US there is no parallel legislation. There is a variety of regulations but no general legislative provisions.

Having left office and having read related literature in the intervening period I can express grave concern about the conduct of clinical trials in many countries. It is notable that efforts to bring in legislation of this nature have met with enormous opposition from the pharmaceutical industry, from many of the testers and from many of the companies directly involved in the conduct of those trials. We have a major benchmark established in statute here in the public interest. I am very anxious, as are the Labour Party and Deputies from all sides of the House, that this legislation be enacted as expeditiously as possible. I am grateful to the Minister and to the Government for having tabled this so soon on the resumption of the Dáil.

I do not propose to go into the various aspects of the Bill. I have listened with great interest to the contributions of my colleagues on all sides of the House. It [603] would be entirely inappropriate for me to go into the aspects of the Bill now, and in any event. Deputy Brendan Howlin is now the spokesperson on health matters for the Labour Party and it will be his responsibility to deal with the Bill on Committee Stage. I am very pleased the Minister has brought forward this Bill so expeditiously. In the framework of measures being tabled in the new Dáil it was not incumbent on the Minister to introduce it so quickly. The Status of Children Bill was the only Bill which he had a formal obligation to place before the Dáil. I look forward to the enactment of this Bill as a matter of urgency.

I share the view of Deputy Swift, when Deputy Keating asked as to the reasons for legislation of this nature. It is manifestly evident that it is very much in the public interest that we should have such legislation. I have the gravest reservations about the work of the Institute of Clinical Pharmacology and particularly about the siting of the institute in the area of a hospital complex. I had no option, in the light of the agreements entered into by the health board with the tacit approval of previous Ministers, but to provide a site for that institute in the place in which it is, because of legal constraints imposed on me by my predecessors and by the health board. These arrangements should have been dealt with on a separate basis outside of a major teaching hospital complex, but that is another story to be written up in due course in the records of the Department of Health. That institute is a very major tester in this area. It is imperative that the provisions of this Bill be applied to it. It is equally important that the other private sector companies such as Elan, who have a major testing complex, should be obliged to conform to the objectives of the Bill and to the guidelines which I would urge the Minister to publish as soon as possible. A fair bit of work has already been done in the Department on the guidelines.

I again thank the Minister, the Minister of State and the officers of the Department of Health for their exceptional [604] endeavours in this work. I also thank the persons who are rarely thanked in this House, the parliamentary draftsmen and others who had to face the drafting of this Bill with little to go on by way of a comparable European or international Bill. They faced the protracted task with great confidence and produced a Bill which should be reviewed in two or three years' time. Then the passage of time will show if it needs further amendment. In that regard, the openness of approach which we had in Seanad Éireann, where there was a very comprehensive debate, should be continued in the public interest.

An Leas-Cheann Comhairle: I now call on Deputy Ahern to make his first contribution in the 25th Dáil.

Mr. D. Ahern: I congratulate you on your election to the office of Leas-Cheann Comhairle. I believe it is an honour you had before and I wish you well in that office. I also wish the Minister for Health, Deputy O'Hanlon, a neighbour of mine from Monaghan, well in his post, a post which is very close to his heart. The people in the medical profession are delighted Deputy O'Hanlon has been elevated to that position.

I am glad there appears to be all-party consent to the Bill. The Bill will have the effect of putting on a regular and statutory basis the practice of using human beings as volunteers and guinea pigs so as to provide better drugs and medicines for the general public. Over the last number of years voluntary controls have been introduced. The fact that there have been voluntary controls is an indication that something should have been done before now. It is nearly 20 years since the first trial took place yet there is no statutory control of procedures relating to clinical trials.

Not so long ago I was a student and a number of my colleagues were interested in taking part in these trials. Some of them were induced to do so because money was available to such participants. This Bill puts the payments on a regular basis and the type of payment to be paid [605] must be specified with the application. I implore the Minister and his officials to keep control over this matter because I have no doubt that people would not participate in these trials unless they were offered some type of inducement. It is easy for people like Deputy Keating to say that people have a moral duty to participate in these trials which will aid the better research of drugs, but I do not believe many people would become involved with clinical trials unless they were offered certain inducements.

It seems to be students and the less well off who participate in these trials. It is important that written consent must be obtained before these people can take part in them. The health and well being of these people is of paramount interest and this should be borne in mind at all stages. Research is secondary to this consideration. Over the past few years there have been a number of tragedies in this country and abroad. There was the thalidomide tragedy where drugs which had not been properly tested were put on the market. Hopefully this Bill will ensure that such a thing will not happen here.

This Bill was brought before Seanad Éireann in slightly smaller form. I understand a number of amendments were made in that House, that nearly 58 amendments have been embodied in this Bill presented to us, including a number of major amendments. I looked at the original Bill as initiated in Seanad Éireann and, with respect to Deputy Desmond, there was in my opinion, a deficiency in it, because there were no time limits involved — there was no time limit in respect of the Minister's approving or rejecting the application, and there was no limit on the time a person was asked to sign the consent form. He could be asked to sign one minute before the trial took place. I am happy to note that the Bill provides for a 12 week period during which the Minister has to either grant or refuse the application. He also may ask for further information. This is important. While this could lead to delay, it is up to the applicants to get their forms [606] in as quickly as possible so that they can be reprocessed.

For some time we have been hearing a great deal about Seanad Éireann, that it is only a talking shop and should be abolished. The fact that so many of their amendments were embodied in this Bill gives the lie to that idea. I read the Seanad debates and was delighted to see that a number of speakers went into great detail on the Bill. I understand some Senators spent some time in drugs factories to see what procedures were involved. I compliment Senators for their contributions to this Bill.

As regards payment to participants, it is highly unlikely that people would embark on such a hazardous undertaking if they were not paid. It is important that the Department control the amounts of payment and the periods for which the participants are paid. To participate in these clinical trials there are two steps an applicant must take. First, he has to get ministerial approval and, second, he has to go through the ethics committee. It is very important that we have these two procedures. The application must be vetted by the Department and the applicant company must tell the officials who they intend putting on the ethics committee. When I first looked at this Bill and realised that the ethics committee would be composed of people proposed by the applicant company, I thought it would lead to a diminution of the impartiality of the ethics committee, but having studied the Bill and read the Seanad debates I realise that since the Minister has the right of approval of the members of that committee, that should ensure that the committee will act properly and responsibly.

The question of insurance is important because anybody who takes part in these trials is taking a very great risk. I am delighted the Minister has included this section in the Bill. We all know how, over the last number of years, the insurance industry has developed. In relation to indemnity insurance, annual premiums have increased by very large amounts, sometimes by as much as 300 per cent. Perhaps this matter has already been [607] examined by the Department and discussed with the companies but I believe there may be a reluctance on the part of insurance companies to get involved in this type of indemnity. It may be necessary for the companies to look outside this country for such insurance cover. If such discussions have not taken place between the Department and the companies, the companies should be told they will have to provide insurance.

The fact that the Minister can revoke permission is a very important safeguard. If a person agreed to participate in a clinical trial it could happen that the trial did not comply with the approval originally obtained. More important, persons taking part in the trial may not be aware that the trial is being changed in some way. I notice that in the Bill there is a provision whereby they have to be notified of any change in the procedure of the clinical trial.

Going back to the question of consent, it is laid down in great detail exactly what the person who is giving consent to take part in a trial should be made aware of before he or she gives consent. The fact that it is a written consent and that it has to be signed at least six days before the trial is important. This amendment was made in the Seanad. I was worried that the clinics would be in a position to get volunteers to sign forms just before the trials took place.

One of the aspects which is not taken on board in the legislation is the fact that there seems to be an assumption that anyone who takes part in a trial is healthy. I read of companies who will be looking for people who are not so healthy. There was one reference to getting geriatrics involved in these trials. While it is important that there should be some research in that area, I would be worried if better control were not kept on trials which involve people who are not in full health and could be bemused.

Finally, I would like to compliment all concerned who worked on the Bill. It is an important Bill because, as I and every other speaker said, there are no statutory controls in this country on the carrying [608] out of clinical trials. If there are problems in later years we can introduce amending legislation but it is important that we get this Bill passed. As a result, those who take part in trials will know that there are statutory controls in regard to those trials.

An Leas-Cheann Comhairle: Again, the Chair is happy to welcome Deputy Michael Lynch on his comeback to the House.

Mr. Lynch: A Leas-Cheann Comhairle, I should like to thank you for your very courteous words of welcome on my return to this House and in turn I congratulate you on your election to the exalted position of Leas-Cheann Comhairle, a position I know you will uphold with the dignity and honour which this House expects of you and we will give you every co-operation during your term of office which I hope will be both long and fruitful.

I should like at the outset to wish the Minister for Health and the Minister of State many happy years in their offices and I wish to congratulate them and the Department on the introduction of this Bill. I also want to put on the record my appreciation of the former Minister for Health, Deputy Desmond, for his input into this legislation. Events of the very recent past made it necessary that legislation of this nature should be introduced to remove any anomalies that existed. I concur with the Minister for Health and other speakers in their words of praise for the exalted Upper House, the Seanad, of which I had the honour and privilege to be a Member for four years, for the manner in which they dealt with this legislation.

The Minister introduced this Bill in the Seanad and left himself open to correction if that was deemed necessary, and open to amendments. There was a very open discussion and during the course of the debate many amendments were put forward and debated. The legislation was teased out and the Minister accepted most of the amendments put forward. This is a complex issue and there are technical issues involved. In some areas, [609] people might find themselves treading very warily because of the technicalities involved. I should like to place on record my appreciation of the former Minister for his attitude towards this legislation.

There is general agreement that legislation is necessary to protect the interests of all those involved in clinical trials. I am glad we have taken a very positive step forward on this issue. Many of us have some idea of the past history of clinical trials. We can even go back to the days of the body snatchers or even to the case more than a century and a half ago of the famous duo of body snatchers who found it profitable to turn to murder and bring the bodies to a famous doctor for dissection. They made a fortune but eventually they were caught and executed. It is important that we move away from that dangerous period in history.

With the advent of new drugs and their impact on human society it is important that we have a controlled development in their production and sale. In brief, I would say the object of any Bill to provide statutory control of clinical trials should be to safeguard to the maximum extent the health and rights of those participating in such trials without limiting the opportunities for medical research and the development of the pharmaceutical industry. Those are the criteria on which we must examine this Bill. The primary objective of medical research has always been and always will be to develop and to provide more effective and safer drugs and medicines.

The need for the involvement of human volunteers in biomedical research is sometimes questioned but the vast majority of people accept unreservedly that clinical trials involving humans are an integral and essential part of any such research. This is the case irrespective of whether the development involves new drugs or drugs which have been on the market for many years. In Ireland, as in most countries, detailed information in relation to results obtained from clinical trials must be submitted for assessment and evaluation before any drug or medicine [610] can be placed on the market. In Ireland this assessment and evaluation is carried out by the National Drugs Advisory Board. Those who say that clinical trials involving human volunteers should not be allowed in Ireland are, in effect, opposing the development of biomedical research and are opposing the development of the pharmaceutical industry.

Although there is no statutory control of clinical trials here at present I understand that the voluntary procedures followed are in line with internationally accepted principles. The two main clinical pharmacology units in operation here have independent ethics committees which are constituted in accordance with internationally accepted guidelines and consist of eminent and distinguished personnel. All studies and trials undertaken in these units are approved by those ethics committees and by the National Drugs Advisory Board.

The Bill provides that in future all clinical trails whether involving new or existing drugs will henceforth be deemed necessary to have the prior approval of the Minister for Health. I agree with that provision. The question of volunteer selection, and payment, will always be controversial and it is not easy to frame legislation which will eliminate controversy in these areas. It is alleged that at the moment the majority of clinical trial participants come from groups who could be said to be either socially or economically disadvantaged such as students or the unemployed. I accept that this is the case and it will continue to be the position. I know of few other categories of people whose lifestyle or work arrangements would enable them to make themselves available for clinical trials which in some cases can last between five and six weeks.

It is sometimes alleged that payments to participants are so low that volunteers involved are being exploited and advantage taken of their economic circumstances. On the other hand there are those who argue that the payments involved are so high as to represent an unfair inducement to influence vulnerable [611] individuals to participate. There will always be those who will argue that there should not be any payment at all on the basis that volunteers should take part in clinical trials in the interest of medical science and not for financial gain. We must be realistic and acknowledge that that does not happen and that volunteers are entitled to receive a reasonable level of recompense for their participation and co-operation in the trials. Public representatives daily come across a new type of poor in Ireland, people who are under severe pressure. I would not like to see those people exploited and it is important that this legislation protects them. It must protect the interests of all involved and help to develop medical research.

An Leas-Cheann Comhairle: In calling on Deputy John Bruton I should like to congratulate him on his appointment as Deputy Leader of the Fine Gael Party, the second largest party in the House. I wish him every success in that capacity.

Mr. Lynch: I should like to extend my congratulations to Deputy Bruton, who also represents the constituency of Meath, and to wish him every good luck in the future.

Mr. J. Bruton: I should like to thank the Leas-Cheann Comhairle and Deputy Lynch for their kind remarks. I recall that the Leas-Cheann Comhairle and I entered the House on the same day. I should like to congratulate him on the office he has attained.

I note that in section 4 a decision must be taken within 12 weeks after the application has been made but it does not appear that the period can be extended in the event of the Minister not having all the information required to help him make a decision. If there is not a provision to extend the period it could become an excuse for needless delay on the part of the Minister, or the administrator concerned, in granting permission. It is possible that the Minister may want to have a brief extension of [612] about three further weeks and I should like to know if that will be a problem. I must confess that I have only read the Bill once and I may have failed to notice a provision that meets the point I made.

I note that according to section 6 a person shall not conduct a clinical trial unless he is a registered medical practitioner or a registered dentist but I am aware that there are new professions in the broad medical sphere coming into existence. I cannot read off the names of them but I am aware that the profession is evolving and I wonder if section 6 should be extended to cater for possible categories of persons who may conduct such trials. The provisions of section 6 (1) (a) are restrictive in that way. According to subsection (2) (a) (i) a trial carried out in the course of ordinary medical practice is exempt from the provisions of the Bill. Can I assume that there is a well understood meaning for the term, “ordinary course of medical practice”, and that this could not be the source of a dispute as to the meaning of the legislation subsequently? Is there case law which defines ordinary medical practice in this context and if not is there a need to insert a definition in the Bill? I note that that subsection does not contain any definition of ordinary medical practice.

In regard to section 9 (7) (a) where reference is made to people who comprehend the purpose of the test that is being administered to them and are, therefore, fit persons to grant consent to the test but are “physically unable to give such consent” I should like the Minister to give examples of where this may arise. I can only imagine that this will arise where the person concerned is extremely ill and, therefore, physically unable to give an indication of his or her views on the matter. I find it hard to understand how they could be simultaneously capable of forming a view but incapable of expressing it. I am puzzled as to the meaning of this subsection. Perhaps the Minister will explain the instances it is envisaged will be catered for under this subsection.

Under section 9 (8) reference is made to the inducements that could be offered [613] to people to undergo tests. These must be as provided for by the permission to undertake the clinical trial. I have examined cursorily the provisions of section 4 which relate to the granting of permission. This section does not give any guidance as to what the Minister's policy would be in that regard. I am sure the Minister can indicate to the House what his policy would be in regard to inducements. His predecessor did so in the Seanad. Given that the question of inducements is one of the central themes of the Bill and that we do not want people to be paid large sums of money in return for taking inordinate risks the extent of which they might not be capable of comprehending, is it correct that the Bill should be silent on the criteria the Minister would apply?

In relation to section 16 the Minister has power to set a scale of fees in respect of an application to conduct tests. It is possible for the Minister to set prohibitively high fees if for some reason he wanted to kill off this activity. There is no control. He has only to obtain the sanction of the Minister for Finance which would probably be easily obtained for anything that would generate revenue. He is not circumscribed in any way by the House from setting prohibitively high fees or derisorily low fees relative to the workload of the Department in examining the applications. There may be a case for inserting a provision which would require the consent of the House to the level of fees in the form of laying the scale of fees under the 21 days' notice provision which does not require debate. I do not understand the meaning of section 16 (3) which refers to the Public Office Fees Act, 1879. That may provide the answer to my question.

I realise my points are more appropriate to Committee Stage but I thought it better to give the Minister notice of them now rather than drafting amendments later which may not be necessary.

Mr. M. Barrett: I congratulate you, Sir, on your election as Leas-Cheann Comhairle. The House made a very wise choice in selecting you because of your [614] previous experience. I have no doubt that you will act as an impartial Leas-Cheann Comhairle. I congratulate Deputy O'Hanlon on his appointment as Minister. I have no doubt that the country will benefit greatly from his appointment. He has knowledge and experience of the many problems which relate to health and hospital matters. I also congratulate Deputy Leyden on his appointment as Minister of State. I wish both Deputies every sucess in their work and hope that their stay in the Department will be long and happy.

There is no provision in existing legislation for a statutory scheme to control and conduct clinical trials. There is great public concern about the absence of such control. A voluntary arrangement for the clearance of submissions for trials by the National Drugs Advisory Board has been in existence for a number of years. However, it is now accepted that comprehensive control of these trials should be governed by a statutory scheme.

The purpose of the Bill is to provide a legal basis for the control of clinical trials involving human participants. The statutory scheme provided for in the Bill will replace the current informal voluntary arrangements. The Bill will provide a legal framework for the control of clinical trials and will permit drug companies to carry out the legitimate and necessary testing of products on the one hand and on the other hand will ensure that the safety of the participants is protected. Any risk to participants will have to be weighed against the potential benefits to be gained from the trial and the Bill reflects the concept that the safety of the participant is paramount when conducting a clinical trial.

There is a two-tier structure proposed in the Bill. The Minister for Health and the National Drugs Advisory Board in the first instance and on the basis of strict criteria can evaluate an application for a clinical trial and can grant approval with modification or amendment or refuse permission or revoke any approval at any stage. The ethics committee are established with the approval of the Minister to approve the details of the trial. They [615] must be satisfied that the strict criteria are met. They must approve the trial and monitor its conduct. It is an integral part of the framework that a participant must give his or her consent freely to participate in the trial. There are further safeguards given so that a participant can opt out of a trial at any time without contractual liability. That is an excellent safeguard. In the past volunteers entered into contracts and found they could not afford to leave them.

The Bill also provides that the sponsor of a trial must have adequate insurance cover to compensate a participant for injuries received as a result of a clinical trial. That is another safeguard which the Bill guarantees the participant. This Bill has passed through all Stages in the Seanad where several amendments, some of a substantial nature, were accepted. These are now included in the Bill. I congratulate all Senators who contributed to the debate.

As it now stands, the Bill represents a consensus of the Seanad and I hope it will be accepted and passed in this House. Clinical trials are essential, not only in the processing and development of new drugs, but in the continual assessment of drugs already on the market to ensure their safety and quality. I have no doubt that in the pre-marketing stage the process of development is lengthy, with various stages of investigation which would involve experimentation on animals and then on human beings.

I realise that medical tests carried out on men or women must be extensive because their well-being must be taken into consideration, especially those suffering from a condition which the new drug is intended to treat. Certain medical conditions could affect the drug on trial. With regard to applications for the marketing of medicines, stringent regulations apply to ensure protection of public health. There is a regulation in most countries, including Ireland, that the results of such trials should be furnished for evaluation prior to receiving authorisation for putting drugs on the market. [616] In Ireland, the detailed assessment is carried out by the National Drugs Advisory Board who advise the Minister for Health on the issue of the product and authorisation or licence to market the medicine.

Section 2 states that the provisions of the Bill shall not apply in respect of any clinical trial which is being conducted at the commencement of this Bill. The section also says that the National Drugs Advisory Board must be notified in relation to the proposed clinical trial.

It is accepted that it is necessary to exempt such trials from the full control of the Bill. It is most important that the authorities are aware of the details of such trials. The Bill provides for the Minister, prior to approval to conduct a trial, to ensure that the approval is obtained by the person wishing to arrange for the conduct of such a clinical trial. A clinical trial involving a product which already has authorisation would not require the prior approval of the Minister for Health but notice would have to be given to the National Drugs Advisory Board. The proposed ethics committees are constituted so as to afford assurance of the justification of the trial and that it is carefully and impartially considered, that doctors and dentists conducting the proposed trials are suitably qualified and competent to carry out such trials in so far as the method of the selection of participants is satisfactory, and that the level of awards to be made to participants does not constitute an excess inducement.

I am aware that in the past many people, especially the unemployed and those on low incomes, were attracted to the idea of participating in such trials because of the financial rewards. Indeed, housewives, deserted wives and single parents who needed additional money to pay ESB bills and so on participated in these trials because of the financial inducements. Sometimes having signed a contract, they felt halfway through the course that they would like to abandon the test but, unfortunately, were not able to do so. The guarantees in this Bill ensure that any volunteer or participant [617] who signs a contract is not obliged to continue and can leave at any time. That is an excellent aspect of the Bill.

Formal approval will be a matter for the Minister for Health but he will have to rely on the expert advice of the National Drugs Advisory Board in making his decision. Applications will be referred to the board for assessment. Section 4 empowers the Minister to apply whatever conditions he considers necessary for the safe conduct of the trial. Section 11 of the Bill empowers the Minister to arrange to have any premises inspected in which clinical trials are being conducted and to be given such information as he thinks fit.

The Bill also obliges persons involved in the conduct of clinical trial to report promptly any suspected adverse reactions which come to light during the course of the trial. Section 6 provides for a clinical trial to be conducted only by a registered medical practitioner or a registered dentist. The ethics committees have a key role to play in deciding on the legitimacy of the proposals for clinical trials and in the supervision of the manner in which such trials are carried out. Section 8 requires that there should be an ethics committee to consider and report on the justification of a clinical trial before such a trial commences.

The question of payment to participants in clinical trials has arisen. It has been suggested that socially disadvantaged groups to whom I referred earlier are exploited and influenced in their decision to participate in a clinical trial because of financial gain. It is envisaged that the payments provided for in section 9 shall be confined to a level which would not provide undue inducement to persons to participate in a clinical trial. A further safeguard in relation to persons participating in clinical trials is provided in section 10 which requires that the person arranging for the conduct of a clinical trial must ensure that there is in force a policy of insurance sufficient to ensure that adequate funds are available to provide appropriate compensation for [618] each participant who may suffer injury or loss as a result of the trial.

Several offences are mentioned in the Bill. Section 12 (1) says that no person shall provide or cause to be provided to another person any information, evidence, documents, samples or other materials which are incorrect or misleading. This should ensure that the information which accompanies the application is accurate. The Bill gives certain safeguards in relation to clinical trials in so far as the ethics committees will be there to consider and report on the justification for clinical trials. This will ensure that the risk to the participants will not outweigh the objectives of the trial. The ethics committees will be particularly concerned about the consent of the participant in the trial. I thank the Minister for introducing this Bill. I hope it will pass all stages quickly in the Dáil and provide greater safeguards in such trials in future.

Debate adjourned.