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Seanad Éireann debate -
Thursday, 2 Oct 1986

Vol. 114 No. 2

Control of Clinical Trials Bill, 1986: Second Stage (Resumed).

Question again proposed: "That the Bill be now read a Second Time."

The Minister is not present.

I think we might forgive the Minister for being late as the Order of Business lasted for three quarters of an hour yesterday. He may not have anticipated the degree of amicability that we have had here today.

The explanatory memorandum which was circulated with the Bill states:

The purpose of this Bill is to provide for a statutory system of controlling clinical trials which involve the testing on individuals of drugs or other substances to establish whether they may have a medical or harmful effect.

I accept that most people agree with the concept and the principle of statutory control in this area. However, it would appear that many eminent people in the medical field have grave reservations about the scope and content of the Bill. The view has been expressed that if enacted it will have a serious detrimental effect on medical care and research. I believe that in the preparation of the Bill the Minister should have had greater regard to the submissions made to him by the Royal College of Physicians and by the Medical Research Council. I would be interested to hear how much consultation the Minister had with the National Drugs Advisory Board during the course of the preparation of the Bill or what was the input of that board into the Bill.

In regard to the section dealing with insurance, had the Minister any consultation with the insurance industry regarding the availability and the cost of the insurance cover which is specified in that section?

The objective 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 at the same time limiting the opportunities for medical research and the development of the pharmaceutical industry here. That is the criterion on which we must examine this Bill.

The primary objective of medical research has always been, and will always 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 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 other countries, detailed information in relation to results obtained from clinical trials must be submitted for assessment and evaluation before any drug or medicine 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 here and are, indeed, opposing the development of the pharmaceutical industry.

Although there is no statutory control of clinical trials in Ireland at present I understand that voluntary procedures are followed which are in line with internationally accepted principles. The two main clinical pharmacology units which are 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 these ethics committees and also by the National Drugs Advisory Board.

The Bill provides that in future all clinical trials whether involving new or existing drugs will henceforth have to have the prior approval of the Minister for Health. The Minister, when introducing the Bill in the House before the summer recess stated:

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. It is the intention that all applications will be referred to the board for assessment and for recommendations as to any conditions which should be attached to his approval.

The Minister went on to point out that the board had been operating an informal scheme of this nature on its own initiative for almost 20 years. However, there is no reference to the board in the Bill. In fact, so far as the bill is concerned, the role of the National Drugs Advisory board is completely ignored. Section 3 provides for the granting of permission by the Minister to a person to undertake the proposed clinical trial in accordance with whatever conditions he, the Minister, may specify. There is no obligation whatever on the Minister to refer the application to the National Drugs Advisory Board. The section outlines the three conditions which must be satisfied and then goes on to state that the Minister shall, as soon as practicable, grant or refuse permission for the proposed clinical trials. "As soon as practicable" could be several months, or even years, after the application is made.

In view of the new procedures laid down in sections 2 and 3 in relation to the submission and processing of applications for clinical trials, and because of the provision which enables the Minister to request additional information, it is inevitable that there will be delays and, in some cases, very long delays before decisions are issued. Such delays — I believe they are inevitable — will undoubtedly result in a considerable reduction in clinical research involving drugs in Ireland. If we are to ensure that the length of such delays is reduced it is essential to have in the section a fixed period during which the Minister will have to make a decision in relation to applications submitted to him.

Sections 2 and 3 would be more satisfactory if they provided that the Minister would act on the advice of the National Drugs Advisory Board, if the authority of the board was increased and if all applications to undertake clinical trials were to be submitted directly to the board rather than to the Minister. This course would involve providing the board with more resources and more personnel but it would be much more satisfactory than the procedure which is outlined in the sections concerned. It would also be a more sensible approach than the procedure outlined in the Bill because it would appear that the Department of Health do not have the necessary expertise to judge complicated research protocols and the various aspects of medical research. I understand that the position at the moment is that the National Drugs Advisory Board are the only competent independent body in this country who have such expertise.

Furthermore, since the members of the National Drugs Advisory Board are appointed by the Minister on the basis of their specialist knowledge and expertise it is regrettable that the Minister has not sufficient confidence in the board to give them a statutory role in relation to the decision-making procedures contained in the Bill. It is generally felt also that the scope of this Bill should be restricted to clinical trials involving new or unlicensed drugs but, as published, the Bill encompasses all aspects of medical research including nutritional studies, investigation of new drugs and any further studies on drugs already licensed for clinical use in Ireland. In my view it would be reasonable to have some distinction drawn between trials involving new drugs and trials involving existing drugs. Perhaps in the case of new drugs it is desirable that the Minister should be the final arbiter of whether a particular trial should be permitted but in the case of trials involving established drugs it is nothing more than a bureaucratic procedure which will result in unnecessary expense and avoidable delay.

The Bill is unclear as regards the conduct of clinical pharmacology practical classes on medical and dental students. It is possible that such practical classes will in future have to be approved by a local ethics committee and permitted by the Minister. It has been stated that practical classes will be exempt but this point needs to be clarified even further. I should also have mentioned that under section 3 there is no obligation on the Minister to give the reasons for a refusal of permission for a proposed clinical trial and there is no provision for an appeal against the Minister's decision. In every case where a trial is approved by the ethics committee and where the Minister refuses to grant permission for the proposed trial the reasons for the refusal should be stated. Furthermore, some appeal mechanism should have been devised and incorporated in the Bill. There should be a right of appeal also against a decision of the Minister taken under section 6 of the Bill. This section enables the Minister to revoke at any time a permission granted to undertake a clinical trial if he is of the opinion that:

(a) the trial or any part thereof is being conducted in a manner which is not in accordance with the permission, or

(b) for any other reason, the trial should not continue.

The Minister should be obliged to state the reason for every decision taken to revoke a permission under this section and the appeal mechanism which I have already suggested should be available for appeals under this section.

Section 7 of the Bill requires that there shall be an ethics committee to consider and report on the justification for each clinical trial before it commences. The Minister, referring to the role of ethics committees when introducing the Bill stated that 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. The Minister went on to state that he was sure that all involved in the conduct of clinical trials would accept that the public have a right to feel satisfied, not only in regard to competence but also the independence of these committees.

Section 2 of the Bill stipulates that it is the person who wishes to perform the trial who will be required to nominate the members of the ethics committee. Furthermore, the Minister may at any time approve of a change in the composition of the ethics committee at the request of the applicant. I wonder will the public accept the independence of an ethics committee constituted in this manner. Would it not be more acceptable if the members of the ethics committee were to be nominated by the health board, the hospital board or the university within whose jurisdiction the trial is being carried out? I understand that the position at the moment is that there are internationally accepted guidelines governing ethics committees and that these guidelines cover the objectives, membership, responsibilities, operation and role of ethics committees. It is also desirable that such committees should be representative of community as well as medical interests, if they are to command public confidence. They will not command public confidence irrespective of the standing or competence of the members unless they are seen to be independent of the person carrying out the trial. Before the Minister makes his decision in relation to an application to undertake a clinical trial it is a condition that the ethics committee for the proposed clinical trial must have given their approval. Even though the ethics committee approval has been given, the Minister may still refuse permission for the trial without giving his reasons for doing so. If this were to happen with any degree of frequency, public confidence in ethics committees constituted and operating in accordance with the provisions of the Bill would be very quickly undermined.

In considering the circumstances under which a proposed clinical trial is to be conducted the ethics committee are obliged under section 7 to have regard to a variety of matters, including the criteria to be used for the selection of participants, the nature and extent of the medical examinations which the participants will be required to undergo before, during and after the trial and the payments which will be made to the participants for taking part in the trial.

Section 8 provides that each participant's written consent must be obtained and that this consent may be withdrawn at any time. These two sections provide comprehensive safeguards for the rights and welfare of participants. However, participants, in addition to being given a comprehensive verbal outline of what is involved in the trial should also be provided with a written summary of the same information, together with the consent form which is to be signed. This written summary of the information and the consent form is to be provided to the participants at least 24 hours before the commencement of the trial. This would eliminate the possibility of an allegation afterwards that some material matter in relation to the trial was not revealed to the participant or that adequate opportunity was not given to the participant to study the wording of the consent form.

The question of volunteer selection and payment will always be controversial and it is not possible to frame legislation which would eliminate controversy in these areas. At the moment it is alleged that 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 that it will continue to be the position, since I know of few other categories of people whose lifestyles or work arrangements would enable them to make themselves available for clinical trials which in some cases last for anything up to five or six weeks. As regards payment to participants, it is sometimes alleged that payments are so low that the volunteers involved are being exploited and that advantage is being 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 and that vulnerable individuals are influenced to participate in clinical trials by the level of the payments offered.

There will always be those who will argue that there should not be any payments 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 have to be realistic and acknowledge that this simply does not happen and that volunteers are entitled to receive a reasonable level of recompense for their participation in and co-operation in the trials in which they participate.

Section 9 (1) of the Bill provides that:

A person shall not—

(a) arrange for the conducting of a clinical trial, or

(b) conduct a clinical trial, or

(c) administer any substance or preparation for the purpose of a clinical trial,

unless there is in force a policy of insurance, issued by an authorised insurer, sufficient to ensure that adequate funds are available to provide appropriate compensation for each participant who may suffer injury or loss as a result of the trial, and a copy of the policy of insurance has been supplied to the Minister.

It is most unlikely that many insurance companies will be interested in offering the type of insurance cover envisaged in the Bill. Where such cover is available the cost is very likely to be most prohibitive and will undoubtedly be a dis-incentive to the carrying out of clinical research in the country. The likelihood is that the requirements of this section will put an end to the clinical research which is carried out in many small units throughout the country. I would not have any objection to this section if it provided that product liability insurance and insurance covering negligence in relation to the conduct of clinical trials should be in force. However, the section provides for no-fault insurance. If the product being tested conforms to all required standards and there is no negligence on the part of those conducting the trial, it is unreasonable to suggest that there is any liability on the part of such persons if something completely unforeseen happens. I understand that in other EC countries a no-fault system of ex gratia payments operates in the event of an accident. This would be a more satisfactory arrangement as far as Ireland is concerned that that provided for in the Bill. It would not put medical research in this country at a disadvantage vis-à-vis similar research elsewhere.

I would also like to point out that the wording "adequate funds" is used in the subsection. Who will determine what are adequate funds for the purpose of this Bill? Sections 13 and 14 deal with offences under the Bill and the penalties for such offences. From reading these sections it appears to me that persons charged with such offences will be presumed guilty until they prove themselves innocent. I would be much happier with these sections if they were based on the principle of being innocent until proven guilty.

Section 15 deals with the fees payable in respect of applications made under the proposed Act as well as other charges considered appropriate by the Minister for Health. The explanatory memorandum states that it is intended that the level of fees and charges will be such as to cover the costs of the scheme. However, there is nothing to prevent the Minister from using this section as a revenue raising mechanism in order to extract revenue from the pharmaceutical industry. This could have detrimental implications for the development of the pharmaceutical industry.

In conclusion I see this Bill in its present form as one which will result in unnecessary bureaucratic delays and restrictions. I believe it will impede medical research and medical progress and will hinder the development of the pharmaceutical industry. At the same time, it will not provide any greater safeguards for the volunteers who participate in clinical trials than those which exist at the moment or which could be provided on a statutory basis by means of a Bill which would make obligatory the procedures which are being voluntarily followed at present. There could also be a licensing mechanism incorporated in such a Bill for all units whether industrial or nonindustrial in which clinical trials are carried out. This would be a more acceptable and a more satisfactory approach towards dealing with this matter. It would provide for greater flexibility than this Bill will allow.

First, I want to welcome the Minister's initiative in introducing this Bill which will give effective control to clinical trials. I also want to thank him for initiating it in this House where I am quite sure—and I know the Minister will be convinced—that the legislation will be debated thoroughly between now and on all stages. The Minister will agree that any legislation brought in here will not alone benefit from being brought in here but is also subject to improvement. That is the purpose of this House. Judging by the Minister's past record in this House I know he will be receptive to ideas and, indeed, willing to accept amendments where he is satisfied they will improve the Bill and achieve what all of us want to achieve in the area of drug testing.

At the outside I accept that there may be defects in sections of the Bill which can be tidied up on Committee Stage and other stages. Like Senator Robinson I want to be positive about it. I want to have a positive view of the Bill because I understand and accept the need for such legislation. That is the proper way to approach it rather than to be negative like Senator Fallon or, indeed, Senator Burke who suggested that the Bill should be scrapped or withdrawn. The vast majority of the people accept this legislation as absolutely vital, having regard to the tragedies which have occurred in this area because of the lack of proper control whether by the industry or by those involved in coaxing people to subject themselves to drug testing. Reflecting on the Bill in this light I have to have regard to the Minister's opening speech last April on the Second Stage of this Bill. He said:

Unfortunately, in Ireland, there is no provision in existing legislation for a statutory scheme to control the conducting of clinical trials and there has, for some time, been grave 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 in existence for a number of years and are in line 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.

That shows that we realise there is an existing procedure which is dealt with by the National Drugs Advisory Board. At this juncture I want to pay tribute to them for the work they have been doing in this field. It is done on a voluntary and informal basis. This subject is so serious that no Minister with responsibility for the health of the nation and the health of people who subject themselves for trials in drug testing can ignore the fact that anything done on a voluntary or informal basis is not sufficient. I want to see legislation which will cover all the aspects outlined in this Bill and in the whole area of new drugs, existing drugs which have had a change of use and the people who subject themselves to trials. In the Minister's opening statement he set down the need for legislation in this area. I will balance that with a submission I have received from one of the vested interests in this area, an existing company involved in drug testing. I quote from a submission they made to me under the heading "General Observations on Clinical Trials":

It is accepted that clinical trials involving existing or proposed new drugs should be controlled in a manner designed to ensure the highest standards of clinical practice and the maximum safety and welfare of participating subjects. The purpose of the proposed Act is apparently to guarantee comprehensive control of such trials by a statutory scheme. While many of the safeguards embodied in the proposed new legislation must be endorsed by all responsible centres and individuals involved in such studies, it is arguable that a system of control other than an Act of the Oireachtas could achieve the same results more effectively and more economically.

That is from one of the companies directly involved in this field every day. They admit it is necessary to have the kind of controls the Minister has outlined in the Bill. The only reservation they have is that they feel it should not be done by legislation. As a legislator I want to defend the right of democratically elected people to legislate in an area where the common good is at stake. Any vested interest which does not accept that legislation is the correct way to do it must be ignoring our statutory obligation. Having regard to all the views I have received on this matter, the area is so serious and the Minister's responsibilities are so great that legislation must control it. Otherwise, when something goes wrong where does one turn to? Where does anybody turn to except to the law? You can talk about common law and anything else you like, but in the area of common law there are many grey areas particularly in regard to people subjecting themselves for testing, the end result of which is a drug being patented and marketed.

Some time ago drugs which were internationally accepted, patented and tested later created problems for unborn infants and had devastating effects on families throughout the western world. The tests were carried out in accordance with internationally accepted standards at that time. Some governments abdictated their responsibility in that area because there was no law to govern it. It was then left to independent inquiries and ex gratia payments were made in tragic circumstances throughout the world. I do not think that is the way to go forward. Any responsible pharmaceutical company will recognise that it is necessary to have some control over the area of testing of their drugs.

The company I quoted went on to say that, despite the wealth of preliminary data that may be generated from laboratory, animal and cell receptive studies, there is no alternative to final evaluation in human volunteers of the efficacy and safety of a new drug or any improved method for administering existing medications. Indeed, it is a virtually worldwide regulatory requirement that such confirmatory human studies should be performed before any new drug or improved dosage form of an existing medication is made available to the medical or dental professions for routine therapy. It is furthermore becoming evident that standard studies in Ireland in the healthy adult male volunteers may not always be sufficient to establish the safety and efficacy of certain medications in special patient groups. The known variations of response to therapy in geriatric patients, for example, indicate the need for validation of such therapy in carefully controlled studies in elderly volunteers. That is the industry's response to the Minister's Bill. They recognise that it needs to be done. They suggest that the law may not be the way to do it — I contend it is the correct way—but they also recognise that humans will have to subject themselves to drug testing and that as of now they need older people— they even refer to them as geriatrics— who will have to subject themselves to various levels of testing before we can move further in the whole area of drug testing.

I have to balance what the industry said and what the Minister said regarding his concern in this area with the submission made to me by the Social Policy Action Group. Let us be absolutely clear that the Minister has a vested interest on behalf of the public at large, on behalf of the consumer, on behalf of the patients' care and on behalf of the people who submit themselves for tests. The industry have a vested interest in making a profit, in good drugs, in getting on the marketplace with them and being able to satisfy themselves, their laboratory technicians and all the experts that the drugs they market are of benefit to the nation. That is a vested interest. But the Social Policy Action Group who have made a submission to me have no vested interest whatsoever. Their sole concern is for the genuine well-being of volunteers. It has been said and confirmed by Senator Mullooly that some of these volunteers are in the socially deprived areas. They are subject to demands made on them by society. They may be dependent on some substance or other, whether it is alcohol or other drugs. Their dependency on that drug allows them to be coaxed into offering themselves for drug testing.

I accept that in the whole area of the provision and marketing of new drugs it is important and acceptable that we must have the human factor. We cannot always depend on drug testing which has been carried out on animals no matter how close the species of animal might be to the human. The only way we and the industry can be satisfied that the drug is safe is to use it in a limited form on human beings. I accept that that is a necessary part of the process of drug testing. I am not condemning it in one way or another. I know that people who are socially deprived can be coaxed into allowing themselves to be used for monetary gain with ulterior motives on their part. We could be into an area that does not create an awareness that some people have been subjected to trials which they may not necessarily have gone into with a free and open mind.

It is appropriate that I put on the record of this House some of the experiences the Social Policy Action Group have had in their research. In commenting on the Bill as a whole, they believe some sections are deficient. I am sure the Minister will comment on these in his reply to the Second Stage debate. They say section 7 does not require ethics committees to be independent of those conducting the clinical trials. Senator Mullooly gave his opinion on that. My opinion is that ethics committees must be seen by everybody to be independent. Nobody is casting any reflections on the professional expertise of people on ethics committees, but those who nominate them can at least be questioned. If I have a drug I want subjected to a test and I nominate professional people to sit on an ethics committee to filter through the application for drug testing, certainly that leaves a question mark. I have complete and utter confidence in professional people who are on ethics committees at present. I have no qualms or conscience whatsoever about the Minister appointing ethics committees because the only vested interest the Minister has is to ensure that they are truly independent and not subjected to pressures from any quarter. If there is any doubt whatsoever about their independence, and the Minister needs to convince the Social Policy Action Group of their independence, section 7 should be strengthened to ensure that any committees that are formed are truly independent of both the industry and all other sections with a vested interest.

They feel that section 8, the informed consent section, is crucial. It is crucial. As I will outline with some of the case histories submitted to me, it is questionable whether some of these people at present being subjected to drug testing are capable of giving an informed consent. On what grounds are they asked to sign something? If it is read to them quickly, do they understand the consequences? That is why the independence of the ethics committee and the regularisation of the type of people who subject themselves to drug testing are so crucial. They are of absolute cardinal importance for people who, for monetary compensation or in the interests of the advancement of medicine are prepared to subject themselves to drug testing. Many medical students do that in the belief that what they are doing is right. I have no doubt that they are quite capable of making that decision, but people in a socially deprived class probably would not be able to make a judgment about the safety or otherwise of the procedures to be followed.

It is said in that section that groups who are particularly vulnerable, such as illiterate people, old people, geriatric patients and psychiatric patients, need additional safeguards which they feel that this Bill does not currently give. If that is true — and the Minister will in his reply outline whether it is true — this is a case to be looked at. It behoves all of us as legislators to ensure that sections are strong enough to give the kind of control that we need in these areas.

Finally, they say that the question of financial or material inducements in relation to clinical trials is not dealt with in the Bill. I quote: "Because of difficult circumstances many people who would not otherwise be involved are either recruiting for or participating in clinical trials. We believe the Bill should take account of these socially disadvantaged people and their situation for disallowing inducements." Any of us who knows anything at all about drug testing — and some of us have more of an interest in that area than others — realise that there would have to be some level of compensation and that it would have to be balanced in such a way that will not persuade genuine people from being involved and will not take advantage of socially deprived sections who will do it for ulterior motives.

The Social Policy Action Group produced a couple of case histories which I think are worth putting on the record of the House because by way of building in our minds a picture of case histories of the socially deprived people who are vulnerable to the industry and without whom at the moment the industry admit they could not carry on. It would be questionable whether people who are dependent on other drugs are suitable to be involved in ordinary drug testing for a whole different purpose. Surely anybody who knows anything about the industry will know that if people are already addicted to a particular drug and allow themselves to be subjected to drug testing for another drug, antibiotic or otherwise, the results could not be depended on. In one of their profiles—they are using pseudonyms here — they refer to a man called Tony who for 12 years has been, they say, "a person whose experience of life is typical of many people who are repeatedly involved in the drug testing industry". They say:

His life has been a passage from one institution to another—orphanage, foster home, orphanage again, the Army, St. Patrick's Prison, Mountjoy Prison and hostels in Ireland and Britain. He is now living in a hostel for homeless men in Dublin.

Tony was recruited for drug testing by a fellow resident in a Dublin hostel. (The person who recruited him has been paid a fee for successfully finding another "volunteer"). Tony is paid £32.80 per week unemployment assistance by the Department of Social Welfare. Clearly this is insufficient to provide for his needs. The money he receives for submitting himself for drug testing is the only way he can provide for himself.

He is regarded as unemployable by employers. His choices are to beg, to rob, or to give himself for drug testing. Society does not tolerate begging and along with robbing it is an offence. The only option is drug testing for which he is paid slightly more than the average wage, or four times as much as he receives on unemployment assistance. His job is testing drugs, but he does not choose this job. By depriving him of the means whereby he can live a healthy life we force him into this situation ...

They question whether he is a volunteer.

The quotation continues:

While partaking in drug trials Tony meets other people known to us— alcoholics, addicts, psychiatric patients, people living in fear of money lenders, social welfare recipients, young people from broken homes who need money for rent and clothing. None of these people are in any sense volunteers.

That is why they are the concern of the social action group.

They are desperate for money. Many of them could not possibly understand the complexities of consent forms.

As a person whose relationship with society has been almost totally through the medium of authoritarian institutions and marginalised peer groups, Tony's life has been determined by society's totally inadequate response to people who do not get a fair start in life. Our society now has a responsibility, at this late stage, to rescue Tony, and people like him from a highly dangerous and uncontrolled medical industry.

I am quoting this because it could be a subject of discussion and argument in this House as to whether the industry as we know it is uncontrolled. Certainly, there are areas in the drug testing industry which we would question, but I am satisfied that with the National Drugs Advisory Board there is some control but it is on a voluntary basis, as the Minister said, and quite informal. The Social Policy Action Group go on to outline various other case histories like that but that is typical of the area we are worried about, people in the socially deprived area who find themselves being asked to submit themselves for drug testing and acquiesce because they need money for other reasons, with no commitment whatsoever to the advancement of science or otherwise.

One of the final submissions I got was a headline from the Irish Medical Times, Volume 20, No. 20 of 16 May. The headline reads: “RCPI says Clinical Trials Bill goes too far.” The report continues:

The new Clinical Trials Bill goes too far and is likely to impede medical progress in this country, according to the Royal College of Physicians of Ireland. The College issued its reaction to the Bill this week and is of the view that the legislation introduces many unnecessary obstacles to research. Despite the scope of the Bill, it does not provide any greater safeguards for participants than the proposals contained in the College's own report on clinical trials.

The College is critical of the fact that the Bill encompasses more than just drug trials.

In a statement it states that the Bill "is seriously out of line with legislation in Europe and North America and will severely impede medical progress in Ireland. As recommended in our report we feel that the Bill should only apply to studies involving the use of drugs which do not have a product licence."

Ministerial approval will have to be sought for studies involving the administration of any "substance" or "preparation", this could include studies of diet.

Obviously, the Royal College of Physicians of Ireland did not read the Minister's speech because in his Second Stage Speech he referred to section 5, stating:

In fact, the definition of clinical trial in section 5 excludes substances which are deemed not to have a medical or deleterious effect and under our current medicines licensing system we do not regard as a medicine, a vitamin or similar dietary constituent which is given at levels within the recommended daily allowance.

It amazes me that——


I am always an optimist. The Senator is not short of optimism himself. I am amazed that a group of professionals like the Royal College of Physicians of Ireland would tend to ignore a specific section which does, in fact, exclude drug testing on items like vitamins or other dietary constituents. It is specifically in the section. You can scare people. I presume general practitioners down the country who are very busy men read headlines like that and certainly do not go back and read the Bill. I have had many submissions made to me by the generic industry in particular. In Ireland, fortunately, we have a very live and active generic drug business with many Irish firms involved in the production of generic drugs, having done so successfully. Indeed they have proved by their success that they have saved the Minister, in his capacity as Minister for Health, and health boards throughout the country many millions of pounds because of the advancement of the generic drug industry.

Generic drugs are drugs that have already been patented elsewhere by multinationals under patent names where patents have expired and the drug can be manufactured without the patent name applying to it. It is the same drug and is used for the same purpose. Anybody in the business of drugs and pharmaceuticals knows that antibiotics and all other drugs of that nature are commonly known by their generic drug name. Because of that the industry has blossomed and has saved the economy many millions of pounds. I do not want to decry the multinational drug patenting companies because they do excellent research in issuing new drugs on to the market and they put them through a system of drug testing which is acceptable.

Most of the problems created in this country in the drug industry are because of the reservations of people in the generic trade who felt when they first read the Bill that generic drugs already on the market would now be subjected to drug testing. I read the Bill in detail. My understanding is that generics already recognised and patented initially and accepted at certain dosage levels can continue to be used without further drug testing. It is only if the recommendations of their dosage level or their application were changed from the original accepted levels when the drug was patented that they are to be subjected to further drug testing. It is clear from the submission made to me by the industry that they accept that if a new recommendation is given of the dosage level or in regard to its use in other diseases in which it is not known to be effective they will be subjected to further trials. The industry accept that that is necessary and those involved in the generic business in my constituency also accept it. The Bill does not require drug testing in existing generic drugs if they are being used in the way for which they were originally designed and tested. I see nothing wrong with subjecting a drug to further testing if its recommendations are changed because we have to balance all interests.

It is appropriate that the industry should make submissions to us. They have made economic submissions because they employ so many people. They resent outside interference in their industry but when anything goes wrong or a life is lost who is responsible? Is it the Minister? Is it the Government? Have we a responsibility to society? Have we a a responsibility to underprivileged people? Should we ignore it and leave it to the drug industry? They have taken on to themselves certain responsibilities as well but this whole area is so complex that it needs legislation to control it and that is why I welcome the Minister's initiative. We all recognise that it is a Government Bill but if it suddenly becomes an unpopular or controversial Bill then it will be a Barry Desmond Bill. The Minister is used to that from previous experience. A Government decision which becomes unpopular becomes the Minister's decision. I know the Minister never shirks from his responsibilities and in this area he is confident enough to be able to convince the public that it is necessary to have legislation in this area.

I accept that we must have drug testing and new drugs. I noted Senator Burke's contribution last night when he said that a member of his family would have died if a new drug had not been administered. This legislation will not stop drugs because before a drug is administered to an acutely ill patient in hospital it must have already achieved a certain status of having passed certain safety tests. I do not know of any general practitioner who is involved in drug testing. They all use tested drugs. They may slightly increase the dosage but a general practitioner, particularly a medical professional person in hospital dealing with patients who were acutely ill would not be involved in the area of experimenting with drugs.

Senator Burke said that the life of a member of his family was saved because there were no such restrictions on testing as those proposed in this Bill. I advance the argument that the opposite is probably true. I unfortunately lost a member of my family because there was no drug to treat the disease and that is still the case in spite of millions being poured into research. We all have views on issues like this complicated by relating them to our own personal experiences. I accept that new drugs are vital and thank God there are people prepared to invest millions of pounds in new drugs where they know there is a need. I know there may be a profit motive but there is nothing wrong with that if society as a whole benefits. I am certain that society benefits from the continued issuing and testing of new drugs. We know how expensive this whole process can be but we are not talking about a pauper industry or an industry that cannot look after itself. We are talking about one of the financially biggest industries in the world, the pharmaceuticals. I am not unduly worried that restrictions like this might put additional costs on the multinational pharmaceutical drug industry as they can write them off against taxes. Patients are becoming immune to existing drugs, particularly antibiotics and it is imperative that drug testing should continue and that we should assist the process of new drugs in every way possible in a controlled way.

I mentioned resistances to antibiotics — who can I blame in this area? I certainly cannot blame the patient because the patient benefits from professional advice. Who prescribes the drugs for a patient? Who over-prescribes drugs for a patient? Who prescribes drugs when they are unnecessary for patients, particularly in the area of antibiotics? What incentive is there under the GMS system to do that? The responsibility in the area of antibiotic immunities lies fairly and squarely with the medical or the veterinary professions because antibiotics have been pumped into animals and humans over the past 20 years with complete and utter disregard for the whole problem of immunity and the building of immunities in the use of drugs.

I agree that common bacteria are becoming resistant to antibiotic treatment simply because they were being used in animals initially which later became used as foodstuffs or in patients without proper bacteriological and sensitivity testing in laboratories. That is where the fault lies, not with the patients. We must depend on professional people's advice at all stages but it is important that the professions would know that those of us who have an interest in this area put a certain amount of responsibility on them also, not because the drugs are toxic in any way but if they are used without proper testing facilities in certain cases there will be immunities.

I am in favour of the principle of new drugs and drug testing and I am also in favour of the need for statutory control. I have a very broad view about how people should be compensated. But the whole area of ethics committees is vital to this legislation. We must ensure that participants know the implications of their role in drug testing and the risks involved. I refer to what has been suggested by Senators Fallon and Mullooly in the area of insurance for the industry. They seem to be concerned that this responsible industry in whose hands we put our lives and the lives of volunteers, is unable to indemnify itself against future claims. What are we talking about? Are we talking about an industry that can insure itself and is capable of it or an industry that is doing something which cannot be insured against?

If that is what they are doing it is time we took effective legislative control because there is no way we can allow any group to carry on testing or experimenting at a level at which the normal insurance factor is taken out. Senator Fallon is an expert on insurance and I respect his views, but I hope he is not suggesting for one moment that because the industry would have difficulty in proving that what they are at is a risk, people should subject themselves to that risk with no cover with the attitude that they will get something if something goes wrong. This ad-hoc ex-gratia payment is not good enough for people who allow themselves to be subjected to drug testing. I want to make sure that if somebody genuinely subjects themselves to drug testing and anything goes wrong it does not have to be negligence. If somebody administering the drug can be proved to have given it in the wrong manner, for example, given it subcutaneously instead of intravenously, that would be negligence and it would be easy enough to prove it. But we are talking about a substance which at the time the test is going on has not been cleared for safe use. Nobody is suggesting then that the Minister should say that he would not bother having cover for people in that area. This is what the whole thing is about. The industry must be able to satisfy an insurance company that some safety standards have been achieved by the drug and that they have not killed a whole lot of animals before they get to the human factor.

I cannot see a problem about insurance cover unless what they are doing is uninsurable, and if that is the case they should not be doing it at all. One cannot wear four hats in this House and try to bend and weave around. One can if one is not going to be honest with oneself. Either what is being done is legitimate and there is a reasonable risk factor which is insurable to protect the underprivileged and the people who are subjecting themselves to testing, or it is not. Unless they can be protected and somebody will meet the case if something goes wrong, not by negligence or lack of knowledge or otherwise, but by the very fact that it is in an untested state with humans, then nobody should be subjecting themselves to drug testing because they are likely to lose their lives and have nobody to give them anything except an ex-gratia payment. Life is not like that. There is no ex-gratia payment for people knocked down on the road except where somebody is not insured and then the industry gets together to cover them.

I am not worried about the insurance factor at all. If it is a risk it can be insured because insurance people are in the business of insuring for risks. I accept that drug testing must go on and that humans will have to be available. I do not accept the submission that nobody should get anything because no testing would go on but there has to be a balance which has to be taken on board by the Minister. I do not accept that he will abdicate his responsibilities in this area. I know his commitments to this area and he has referred to the inducements that are being offered by way of payments to participants and he admits that it is a contentious one. We have all had representations about it.

There are people who are in a category where they can be exploited. Nobody is suggesting that the industry is exploiting them. The industry is looking for volunteers. They use methods that can be interpreted as being close to exploitation. That is an area of argument. However, I am satisfied that the whole area of drug testing needs to be tidied up. Usually the drugs that are being tested in this country are already generic drugs which are being used for other purposes and whose dosage levels or prescription area has been widened. The industry go through the National Drugs Advisory Board on an ad-hoc basis. That is good enough. I do not think the industry accepts that it is good enough. In a way they welcome the fact that we are doing it in a proper statutory way.

Perhaps the National Drugs Advisory Board feel that they were slighted in not being mentioned in the Bill. I would envisage that the new formula the Minister will set up may encompass some of the existing members of the National Drugs Advisory Board but they will be put together in a regular statutory recognised formal way and not an ad-hoc, informal way as it is at the moment. I have to pay tribute to their contribution in this area in the past. They only come into play when they are asked to by the industry. The industry submits to them certain data, certain facts and figures, blood levels and blood counts and then they take action. If the industry did not do that the National Drugs Advisory Board would never hear of a new recommendation for a drug, but they cannot be marketed without having gone through that process.

We are tidying up the area, and it is high time we did it. It is a pity that we had to have a loss of life before somebody took action but I am glad that the Government have seen fit to take action. I look forward to the Minister's response to this Second Stage debate. He will have a useful debate in this House and he will be able to make a judgment that in spite of the reservations many people have about sections of it, by the time we are finished debating it it will have been a useful piece of legislation that will benefit society as a whole and benefit people who take the drugs that will be tested and perfected. We will ensure that the underprivileged are not exploited in the process. We will ensure that the industry can survive and go on to greater things and have more approval for what they are doing and more acceptability for their product by consumers. At the end of the day what we have to protect is not the vested interests of any side, but the consumer, each one of us and our children and our children's children in the future and our relatives and friends who are subjecting themselves, in the interests of medical science, to drug testing.

I welcome the Bill and I look forward to the amendments which will overcome some of the problems that have been brought to our attention by various interest groups.

To some extent we are circumscribed in our discussions in this area by the mystique with which the medical profession has cloaked itself and which all the professions wrap around themselves. My good friend, Senator Robb, has many times threatened to put down a series of motions to the effect that the legal profession is a conspiracy against the laity, that the medical profession is a conspiracy against the laity and that all professions are conspiracies against the laity. If one listens to the considerable amount of public debate about any area where "experts" are supposed to be involved one will find quite a remarkable degree of denigration of the whole idea of democratic accountability because some will say after all, they are only TDs, Senators and so on, and what does the Minister know about medicine, he was never a doctor. That is the sort of thinking which at its core has a streak of something close to fascism, the idea that the public, society and the democratic process is somehow incompetent to deal with things because there are experts to deal with them. The worst thing we could have would be a society where people's professional expertise gave them the authority per se, without any accountability, to decide what was good for us in many areas. There is a lot to be said for democracy, there are a lot of deficiencies built into democracy but the process whereby ordinary people, to a greater or lesser extent, must be satisfied that a particular profession or a particular practice is operated in the interests of society and in a way which does not damage society is a very fundamental one and we should not apologise for it. When we are dealing with complex legislation I do not think Members should feel obliged to stand up and almost apologise for the fact that they are not lawyers, doctors or scientists.

It is the responsibility of those who have professional expertise, and in my view it is a measure of their expertise, that they be able to make what they do comprehensible, understandable and, therefore, accountable to ordinary people. If they cannot make it comprehensible and intelligible to ordinary people they are not competent to do their job. It is part of the job of any professional to be accountable to ordinary people for what he does and to express himself or herself in language which is comprehensible to other people. It is the very nature of democracy. I am suspicious of any area of expertise in society being withdrawn because it is too complex, too difficult, or too technical and implicitly, therefore, the ordinary Joe Soap could not comprehend it. That effectively means that democracy cannot apply in all sorts of areas.

We have in our society — Senator Ferris, the Minister and I at least agree on this — a view that the whole area of the way the market and economics operate is too difficult and complex to be democratically accountable and, therefore, we will leave it to primitive brute market forces to determine how certain things are organised. That is the most widespread derogation of democracy in many of our societies and it goes through all of the professions. In a particular way the medical profession has cloaked itself in this mystique. Anybody who has been in hospital and witnessed the arrival of the consultant with a ritual and an obeisance that an Archbishop would not now expect will know the way in which this mystique is generated and preserved. We should not apologise to the medical profession for the fact that we, as Members of the democratically elected Houses of the Oireachtas, want to know, and to regulate, and insist on our right to regulate, the way any of these professions operate in their dealings with the public.

However, there is no question but that drug testing is a necessary part of the development of medicine. There is no question either but that proper drug testing must incorporate tests which involve human beings. In the area where I have some professional competence there is too much evidence at this stage that, for instance, substances that are determined to be entirely non-toxic in animal tests turn out to have quite severe toxic affects on humans. There are substances, for instance, which have never been shown to be carcinogenic in animal tests which do turn out to be carcinogenic for humans. Consequently when one is talking about therapeutic drugs which are going to be used on people who are unwell one is, therefore, obviously going to have to do tests on humans. We do not have any disagreement in principle with that. On the other hand it is part of the mystique of medicine to pretend that it is the development of drugs and of medical science which has produced huge declines in things like infant mortality rates and declines in mortality rates generally.

No less a person than the medical correspondent of The Irish Times a few years ago pointed out that it was in fact a combination of good hygiene, good sanitation and clean water which was the major contributor to the extension of good health. In other words, it was recognition of the fact that hygiene, clean water and good sanitation did far more to improve the health of our community than medicine. That is not to denigrate the successes of medicine but it is to put it in perspective. In fact it was the decisions of society to actually invest large sums of the resources of each society in things like clean water, good sanitation and education in basic hygiene which contributed most to this. The medical profession had a part to play but they are not God nor are they substitutes for God nor have they any right to give the impression to a society that they have some sort of God given role in determining how a society conducts itself.

Drugs testing is a necessary part of medicine. It was recognised in all the submissions we received that it is a necessary part of medical research but it is a difficult and dangerous part. When one adds in the inherent risks involved, and the inherent difficulties involved, the fact that drug testing on a large scale here is conducted by private profit-orientated organisations one has an extra dimension of the questionability involved. When one sees that at least in one case this development has resulted in the enrichment to multiple-millionaire status of the proprietor of one of these clinics, society has every reason to be concerned and every reason to feel that we have a right to know and to know in detail.

The Minister is perfectly right in introducing the Bill. I have qualms and questions about various aspects of the Bill but I have no doubt but that I will unequivocally vote in favour of it on Second Stage and I look forward to a very interesting Committee Stage debate on the meanings of various phrases within the Bill.

I heard Senator Ferris refer to that part of the Minister's speech where the Minister appeared to dismiss one of the major reservations of the medical professions, that the Bill as it stands is all-embracing. I am in the position where I have vigorous domestic representations made to me about matters to do with the medical profession and therefore, I must be diplomatic in whom I choose to believe, in public at least, about these things. I will either have my wife or my brother descending upon me if I say that I believe the Minister and not them. I will simply say that I will suspend judgment but I do think that if the Bill is as the medical profession identified it, the point was well made. I do not think that there is any intention of extending a provision to deal with new untested drugs into other areas but there may be a case for rewriting some of the sections, regardless of whether the Minister believes it to be justified, to make perfectly clear what is intended, if for no other reason than to calm down what are, perhaps, unjustified fears.

I remember in the course of the debate on the Criminal Justice Bill the then Minister for Justice felt obliged in order to allay fears on a number of occasions to add in phrases which he felt were unnecessary. I suggest to the Minister that, perhaps, in order to calm down some of the fears among the medical profession on this area, it might be worthwhile considering rewriting some of the phrases, even if he is satisfied that the fears are unjustified. It is a good idea and I do not need to give a professional politician lectures about what are good ideas to calm down people. It might be nice for the Minister on one occasion to calm down the medical profession for a while. By and large I think he is perfectly right not to calm them down but on this issue it might be no harm. I must point out that unlike most Members I need votes from the medical profession so I will have to be careful in what I say about them. Many of them are constituents of mine but they usually forgive me my excesses.

I missed the Minister's introduction and I apologise to him for that; it was not through any disinterest, I just could not be here, but I would be interested to know why the National Drugs Advisory Board is not referred to in the Bill? Anybody I talked to could not tell me why the NDAB is somehow separate from this.

My sympathies for the fears of the medical profession are not held without severe qualification, particularly having read the leaflet produced by the Institute of Clinical Pharmacology. Under the heading, Medical Committee ICP, paragraph 3 they say:

In addition, a large number of other doctors, consultants and general practitioners, assist ICP in the conduct of clinical studies in Ireland, Western Europe and the USA.

That extends the area of clinical studies well beyond two premises and two places into the activities of large numbers, to quote themselves "general practitioners and consultants". This apparent distinction that some people present to us between the buildings where things are done and the consultant or GP doing his ordinary GP practice is clearly not nearly as definite as some people in the medical profession would have us believe. There is clearly a case for regulating this sort of activity.

Another area that I am familiar with in the area of psychiatry is the well advertised drug company functions where representatives of various pharmaceutical firms entertain virtually the entire medical staff of many psychiatric hospitals to quite extraordinarily expensive meals in the most extraordinarily expensive restaurants in most cities and towns, and then expect them to make dispassionate decisions about which drugs they should or should not prescribe when there are a range of drugs available. I do not attribute sanctity to myself or to the medical profession, and while they may feel it is unfair to suggest that there should be some regulation about how they use various drugs, it would be much easier to accept that it was only dispassionate professional judgment that was being exercised, if all of the medical profession as a group decided that these drug company functions were an unacceptable attempt to influence professional decisions. I am not saying that good meals can actually influence doctors, I am simply saying that it would be far more difficult for the medical profession to convince the public that they take all these decisions entirely dispassionately, if there was any form of cosy relationship between themselves and those who are going to make a lot of money from the sale of the drugs.

The principle of testing new drugs on human subjects is not in dispute. The question is how this should be done, by whom it should be done, on whom it should be done and how all of that should be regulated. There is justified public concern which came spectacularily to public attention with the regrettable death of Niall Rush. Following that, the public became aware of the fact that there were two multi-million pound drug testing units in operation here and many people including the people who "volunteered" for these tests began to wonder about the actual basis for these tests, the motivation for them and the way in which these tests were being carried out. There is a certain irony in the phraseology of section 7 (3) of the Bill in terms of ethics committees:

The ethics committee shall not consider the proposed clinical trial justified unless they are satisfied that the risks to be incurred by participants would be commensurate with the objectives of the trial.

That is perfectly correct phraseology, but when one considers the extent to which a large part of medical research today is devoted to devising drugs to counteract the diseases of affluence — heart disease, blood pressure and indeed the diseases of western society, particularly cancer — and when one considers the spectacle presented to the public, that most of the people who are being subjected to these tests are manifestly not part of affluent western society, there is a certain irony in assessing that "the risks are commensurate with the objectives of the trial". Those who take the risks are not those who benefit from the society which is creating the problem and probably will not benefit from the research. Therefore, society became justifiably concerned.

Up to now society's concern has been allayed through the device of ethic committees. It would be preferable to have a national ethics committee dealing with this whole area than an ethics committee related to specific projects. We are a small country, we will have a limited amount of clinical testing going on and therefore it would be preferable to have national standards and an independent ethics committee appointed presumably by the Minister with absolutely no direct or indirect connection with the clinics. When one considers the risks involved, the area involved, and the additional problem of these clinics being profit-orientated, privately owned places which have identified a way of doing something which makes a lot of money, they must be carefully supervised and a detachment and lack of any overlap of interest must be clear to the public.

This Bill and any amendments to it will have to be considered carefully to ensure that the ethics committees are not only independent but are clearly seen to be independent and my preference would be for a national ethics committee.

We all accept that there is a need for these tests but a large part of the debate has centred on who should be subjected to the tests and on the concept of informed consent, that the people who accept the risks of taking these tests should be clearly seen to consent freely. We must not address this matter in terms of "what would one do, if..." What has been said to us over and over again is that if the unemployed or students were not allowed to have these tests done, then who would have them done? By "informed consent" I presume we mean consent being freely given. I can have an informed consent, if I am to be executed tomorrow morning. I can be informed and give my consent because there is little else I can do about it. Real consent, implies a reasonable choice between reasonably acceptable alternatives. It is difficult to argue that anybody on £34 a week is really in a position to give free, informed consent if they are offered—different people quote different figures and talk about it so differently it is almost impossible to know what is going on — somewhere in the region of £20 a day to submit themselves to tests. To my mind, people's freedom to choose is severely inhibited if that is the case. If people on limited incomes are those who are doing these tests, are we really in a position to say that they ever give free, informed consent?

In addition to that, it is only relatively recently that one of these clinics got around to saying that people who could not read would not be accepted for tests. I have here a consent form for one of those clinics. It seems extremely impressive but there is the possibility that a person who is given this form is unemployed, poorly educated and cannot read and may find complicating such phraseology as that the drug was previously given to human volunteers and well tolerated, that it acts by blocking the change of Angiotensin I to Angiotensin II, both of which occur naturally in the body and that to establish this it is necessary to give Angiotensin I and Angiotensin II by way of a catheter placed in an arm vein. I think I understand what that means but I am not deluded into believing that half the world understands what it means. I am even less prepared to believe that the average guest in a night shelter or hostel in Dublin or a large proportion of our unemployed—given their inadequate education — are in a position to understand what that means. I am even more convinced that if somebody cannot read it is very difficult for them to sign a form saying, "I have read this and I understand what it means". I am satisfied that it is only recently that one of these clinics came to the view that if a person could not read, they could not have sufficient information to make a prejudgment about something like this. That leads me back to the conclusion that I have come to. I do not believe it is possible to give free consent if you are going to become a lot better off by virtue of becoming a subject for these tests.

That leads us on to the whole question of payment. I understand that the World Health Organisation specifically said in 1982—for this information I am quoting from a document supplied to me by the Social Policy Action Group, an extract from a contribution from Mary Banotti, MEP that the volunteers should be reimbursed for any loss of earning and for expenses, but that the amount of money should not be used as an incentive, since this would detract from the validity of the "consent" given. That is a perfectly reasonable view. The money should not be an incentive. If the person is living on £30 a week, £5 a day is an incentive. Even £1 a day is an incentive. The actual disposable income that somebody who is unemployed and living on his own has cannot be more than £5 or £6 a week when you take rent, electricity and basic food out of it. The actual spare cash that people have to do something with other than live on is very limited. Even £1 a day becomes an incentive.

We also had denials that people were being paid to recruit people. This was a saga in itself. But apparently the clinic which was in the news has now accepted that people are paid to recruit people. I quote from the ICP's leaflet which was supplied to most Members of the Oireachtas. It states under the heading, Volunteer Recruitment:

1. Recruitment in undertaken on a word-of-mouth basis, as it appears to be impossible to advertise for volunteers in this country.

2. To enlarge the volunteer pool, a system of finders fees is undertaken intermittently.

Given the fairly vigorous denials which emanated from that source for a long time that people were paid to recruit, it is interesting that they now mention in a publicity leaflet that finders' fees are undertaken intermittently. They try to blame society for this because they say if they were allowed to advertise they would not need to get involved in finders' fees. But the consequences of advertising for something like this would be quite horrific.

The World Health Organisation tells us that there should be no question of incentive involved, that people's reasonable expenses should be reimbursed. That, presumably, is the standard we all aspire to. Imagine my dismay when I got a letter from the other company in the country who are involved in clinical testing. Apart from a fairly vulgar threat that their plant would be closed down if this Bill in its present form is implemented they say:

In addition, the approved recompense to subjects volunteering for essential studies in...

this company's

...Clinical Pharmacology Unit stimulates the local economy by increasing the disposable income of these individuals.

In the course of the same letter, the company says that their guidelines for the conduct of these investigations not only conform to those proposed in the Bill but also fulfil the requirements of the most demanding regulatory authorities in the world.

On the other hand, I have evidence that the World Health Organisation says that there should not be incentives involved. But a company which is involved in this practice on a large scale tells us that the money they are paying their volunteers is enough to stimulate the local economy. If you are reimbursing expenses there is no net contribution to the local economy. That is quite clear because you are simply recompensing people for money they have lost and therefore there is no stimulation. One of the companies involved now tells us that they are actually paying people to do these tests to the extent that they are stimulating the local economy. In the next paragraph they tell us that they are working to the highest international standards. All of that increases my suspicion. That would be bad enough if they were simply taking in people and persuading them to take time of work. But nobody is under any illusion any more—it was denied for a long time—that the vast majority of those who are subjected to these tests are unemployed people.

Senator Ferris said that nobody was suggesting that these companies are exploiting people. It all depends on your definition of exploitation. I am reminded of the European Court's decision that there was no torture being practised in Northern Ireland because those involved did not set out to torture people. It was something which escaped me at the time but they suggested something like that. You do not have to decide somewhere in your heart that you are going to exploit people in order to do so. You could be the most kind, charitable person in the world in your daily life, but if you choose to pay buttons to people who are working for you, you are exploiting them whether or not you realise it. Similarly, if companies base their drug testing regimes on the presumption that they can get large numbers of unemployed people to do their tests, working on the fact that these are the people who (a) are available and (b) need the money, that is exploitation. Those companies are exploiting people whether they have a guilty or a clear conscience about the matter. Given what the World Health Organisation has clearly said, that there should be no incentives of a cash kind to people to undergo these tests, then quite clearly— if we continue to tolerate the fact that most of those who undergo these tests do so because they need the money— exploitation is going on.

The story is that you will not get anybody to do these tests if you do not pay them. At least that is logical, but it flies in the face of international guidelines about how these tests should be done. If people believe that we should pay people to do these tests then let us either say to the World Health Organisation that we are not going to operate or else let us accept that the tests cannot be done. But you cannot claim on the one hand that all these companies are operating to the highest international standards and at the same time say that people will have to be given incentives of a cash kind to undergo these tests. There is a contradiction there and at the centre of the contradiction is the exploitation of people on very low incomes in Irish society.

That exploitation must end. We will have to decide whether we are eliminating exploitation or simply trying to regulate it. Like violence, exploitation and slavery cannot be regulated. You either have them or you do not have them. There is no regulation of exploitation. The South Africans are trying to do it at present with spectacular failure on a large scale. We should not kid ourselves. We will either get rid of exploitation of people by eliminating any sort of inducements or payments which would induce people to do something they would not otherwise do or else we will get used to the fact that we are tolerating the exploitation of the poorest in our society in order to provide drugs which many of us, but not all, will benefit from. I accept that those Members of this House who have reason to be particularly grateful for the development of new drugs would feel particularly sensitive about that. It is not just those of us who have spectacular illnesses who have reason to be grateful. All of us in this House who have children, for instance, have seen the benefits of antibiotics where relatively minor ailments which 50 years ago would have been life threatening can be taken for granted and dealt with quite calmly. There is no fear and panic. I accept that we all benefit to some extent from these developments.

What has surfaced in this whole issue as it has become public over the last number of years is that there is a sordid background to it. There is evidence of recruitment in hostels and night shelters. There is evidence of people recognising this as a source of easy money. I would like to quote from a long article in The Sunday Press dated 2 December 1984. It is about a murder case in Athlone. The gentleman does not deserve to have his name mentioned. He is guilty of no crime in the eyes of the law. The article states:

"he heard of the "soft money" to be made drug testing at the Institute of Clinical Pharmacology in Dublin... By mid-1983, he had completed around 12 separate courses at the Institute, earning fees ranging from £150 to £1,200 per course.

He then heard about the other clinic, he went there and made more money. There is sufficient documented evidence at this stage that whatever the normal aspirations of these clinics, whatever good they have done, whatever the value they are to medical science and to the medical profession, whatever you want to say about all of that, they have been involved in dubious practises which are effectively, whatever their intent, exploitation of the poorest in our society.

In many countries they will tell you, for instance, that you cannot run a blood transfusion service unless you pay people to give blood because they would say who would give blood if they were not getting paid for it. We have demonstrated in this country and many countries in Europe have done so that it is perfectly feasible to run a blood transfusion service on a free donation basis. It is equally possible if the same sort of public will, goodwill, understanding and belief that this is in the interests of the community and people's health generally can be got across to people, to run clinical tests on a true volunteer basis where people's legitimate expenses are recompensed. As long as the public are suspicious of what these clinics do and suspicious of their motives, you are going to have people wide open for exploitation. With 250,000 people unemployed the opportunities for exploitation are enormous. I would be interested to hear — perhaps, the Minister can tell me — what is done about drug trials in countries such as Switzerland, Austria and Sweden who have very low levels of unemployment. Switzerland has a well developed pharmaceutical industry. I would be interested to know if there is any clinical testing going on in Switzerland, for instance, which has a huge involvement in the international pharmaceutical industry.

In conclusion, we should not be too circumspect in our language. It is important to remember that international pharmaceutical companies who have contributed considerably to medical research have also made an enormous amount of money out of that contribution. They do not show the highest of ethical standards when drugs are identified as being of unacceptably high risk content in western society. They promptly shift those same drugs off to Third World countries to sell them there — drugs which are known to be too risky to be sold on the western market. There are many well documented cases of this taking place. While I do not want to get involved in a diatribe against the international pharmaceutical industry, we need to recognise that their own ethical record is not such as to suggest that they always meet the highest of standards. When you get involved in this interface between research and people and when you find people at that interface who desperately need money, who are poorly educated, whose comprehension is obviously going to be less than complete, you have the risk and the practice of exploitation.

I welcome the Bill. I hope we can talk at length on Committee Stage on the question of inducements and their abolition or, at least, their reduction to the level where they are no more than genuine expenses. By way of a query, if unemployed people are actually undergoing clinical tests for three or four weeks, as is suggested, have the Department of Social Welfare ever told one of those people that they were not available for work and, therefore, not entitled to their dole? People in much more innocent circumstances with far more innocent activities including working for voluntary organisations have suffered at the hands of the Department of Social Welfare because they were not "available for work". How many of the vast number of unemployed people who go through these tests have ever been ruled to be non-available for work? Is it that the Department of Social Welfare do not know or is it because of the level of lobbying and effectiveness and, perhaps, importance to the economy of these organisations that they do not say so? I welcome the Bill. I congratulate the Minister for it and look forward to an interesting debate on Committee Stage.

In the first instance, I would like to say that I am very pleased to be able to make a contribution on this Bill. Seldom have I received such an extent of apprehension in the medical world and the community to the contents of a Bill. That is not to suggest that there is not a great deal of need to get some statutory control into the area of clinical trials. That is appreciated by everybody. I share the need to move into the area of introducing statutory controls into clinical trials, not just clinical trials that have preoccupied some of the contributors to this debate, those which take place by drug companies, but even into clinical trials that take place quite regularly in hospitals as part of the treatment of patients.

The need for this area of control arose in 1984 because of the sad death of Niall Rush in Dublin. I am quite satisfied that one death is enough to move on the need to bring in a statutory control of a suitable variety that will not cause apprehension to the medical world and the public. In other words, it is not the introduction of the controls that is on people's minds, it is the kind of introduction proposed in the Bill that has people so disturbed at present.

I would like to deal with a fairly sizeable inconsistency which exists between the published Bill and the explanatory memorandum. I have read the Bill. Section 3 states that where in relation to a proposal to arrange for the conducting of a clinical trial ... then the Minister shall as soon as practical

(i) grant permission for the proposed clinical trial to be undertaken in accordance with the application, or

(ii) grant permission for the proposed clinical trial to be undertaken in accordance with the application subject to such modifications or conditions as he may specify, or

(iii) refuse to grant permission for the proposed clinical trial to be undertaken.

That seems to vest the decision in relation to an application for a clinical trial in the Minister. On the other hand, page 11 of the published report of the Minister's speech of 27 May 1986 — for which unfortunately I was not present as I was out of the country — says:

While formal approval would be a matter for the Minister, he will rely on the expert advice of the National Drugs Advisory Board in arriving at his decisions. It is the intention that all applications will be referred to the board for assessment and for recommendations as to any conditions which would be attached to his approval.

The National Drugs Advisory Board were set up, as I understand, about 25 years ago. I have a list here showing the eminence of the people who are members of that board at present, with Professor Kevin O'Malley as chairman. I do not understand why that body could not be given statutory control. They are the experts in this area. With all due respect to the Department of Health, even they must concede that the level of expertise in that Department — I am talking particularly about the professional staff of the Department of Health — and the experience of any of the professional staff in that Department in the area of clinical trials would be minuscule. I suggest that what is required here is for the Minister at the conclusion of this debate — and I among others will be awaiting that response — to undertake to introduce an amendment on Committee Stage to change the whole structure of this Bill and give statutory control to the National Drugs Advisory Board.

I appreciate the necessity for statutory controls. I say that not just because of the untimely death of Niall Rush two years ago but because of the concern I have — one that I am sure is shared by the Minister and a number of the contributors to this debate — for the vulnerable in our society, people living in hostels and shelters of one kind or another who have been persuaded in the recent past to make themselves available as participants in clinical trials. People living like that are vulnerable because their income is small. They are vulnerable because they are persuaded that there is a great deal of safety in the trial that is taking place but perhaps there is less safety than they are able to understand. We need an assurance on their behalf. People who are vulnerable and in difficulties in our society should be protected and these trials should be conducted with attention paid to the most minuscule detail of how they give their consent and the extent to which the ethics committee monitor what is going on. The conduct of the whole trial must be up to a very high standard of efficiency and a caring attitude must be seen to emanate from the Department of Health and from the Oireachtas in relation to the protection of the participants.

I have been a member of the Eastern Health Board for 12 years and was Chairman of that board from 1978 to 1980 — not that long ago. I am currently a member and also a member of a number of voluntary hospitals in this city. Rather than getting involved in the details of the Bill, with which I might preoccupy myself with the Cathaoirleach's co-operation a little later in this debate, I kept to one central concern of mine. That is my concern as to why the National Drugs Advisory Board — although mentioned in his Second Stage speech by the Minister as being the referral agency he would use in approving clinical trials — are not made part and parcel of the Bill, included in the text of the Bill and given the statutory role of deciding on clinical trials. That, to me, is not much of a surprise.

To be frank — and I hope the Minister will not take this in any personal way because it is not intended personally; it goes back to long before the Minister arrived in the Department of Health — there is an obsession in the Department of Health which is not to be seen in many other Departments. Certainly, in the sister Department that runs from the Custom House — The Department of the Environment — quite a different attitude is taken to decentralising activity in the area of the environment. In regard to the health services there has been a grasping attitude in the Department and, presumably, the permanent Civil Service. They have taken an interest in regulating and controlling every possible activity of every possible subordinate agency involved in a hospital of any kind in this State in recent years. That has been happening over a period going back before this administration to the administration of Fianna Fáil Governments. It is a serious development which requires very serious examination by way of public debate.

I do not say those words lightly. I am not saying them with a lack of knowledge of what I am talking about. I can instance reasons for mentioning them. My concern is not just about the centralising of all decision making in what must be a small Aireacht in the Department of Health, but about the dispiriting of staffs, medical and paramedical and other staffs, and those interested in the health services and the hospital system. Without public debate, in a most undemocratic way the Department have taken on far too much of a role in relation to the running of the health services.

It is no great surprise to me that the National Drugs Advisory Board — who are the expert people in this area — were not mentioned in the Bill. They have been specifically excluded. We have in their place the Minister for Health or the permanent Civil Service who will deal with these things as they see fit, accept or not accept the recommendations of the National Drugs Advisory Board who, we understand from the Minister's Second Stage speech, will be asked in every case for their view. It is worth pointing out that in the drafting of the Bill there is no limit on how long the Minister can take to decide. There is no appeal procedure. There is a timeless zone which, when you think about it, is quite a worry because we are dealing with the need to produce drugs urgently for the treatment of patients. If we require a time limit in relation to the processing of planning applications, I do not see why we cannot have a time limit in relation to the processing of applications for clinical trials.

I said hard things a few minutes ago in relation to the Department of Health. Last year I approached the Taoiseach about the need for the establishment of a joint committee on health and social welfare which would do something about the absence of debate at a level of decision making that seems to be the case in relation to the health services. I am sure the Minister will tell me that he has eight statutory health boards. I know he has eight statutory health boards, I have been a member of one for a considerable time.

Unlike the intention in the 1970 Health Act, bit by bit every possible sanction since 1980, including minor capital works, must get the approval of the Department of Health insted of allocating a certain sum to the respective health boards, bearing in mind their needs and the size and extent of the activities for which they are responsible. We should leave it to them to disburse the money. I have some apprehension about what kind of restructuring is going on in the Department of Health as I heard that there will be a reduction from eight health boards to three. Perhaps that restructuring might involve the health boards having some role in relation to the voluntary hospitals, which is a very necessary step. The role at the moment is a direct role between the Department of Health and the voluntary hospitals.

I am also apprehensive about what may be going on in discussions with the Voluntary Health Insurance Board. A lot of this movement has to do with cash and control of the financial purse of the Department of Health. We are living in a society where other people should be responsible besides the Minister and those who happen to be senior in the Department of Health. Those people could be encouraged by feeling that they are involved in decision making and that all decisions are not made for them which seem to be the case at present, to an extent which is worrying.

There are aspects of this Bill that concern me and apprehension about the Bill is quite widespread. I have been told in the past couple of weeks that a study which was to take place in this country has gone to Belgium. There is apprehension at the level of the World Health Organisation——

I can dispel that apprehension in regard to the WHO.

That is what I have been informed by a reputable source.

The Senator should name his source and declare his interest.

There is no question about it. I can name my sources and am willing to do so but I had better get approval first. I will certainly be able to contribute that at a later stage in this debate. That is the information I have been given. The Minister went to some trouble towards the end of his Second Stage speech to mention a series of organisations who were consulted in relation to the Bill. I quote from column 16 of the Official Report, of 27 May 1986:

Bodies consulted prior to the publication of the Bill included the National Drugs Advisory Board, the Federation of Irish Chemical Industries, the Federated Dublin Voluntary Hospitals, the Medical Research Council, the Irish Medical Organisation, the National Health Council and the Social Policy Action Group. I also considered carefully the statement published after the Bill was circulated by the Royal College of Physicians on the text of the Bill and I hope I will have reassured them in relation to a number of aspects on which they expressed concern.

I understand — I am sure the Minister will correct me if I am wrong — that these organisations or many of them were written to by the Department of Health and asked for their views. Their views were then looked at by way of the compilation of the Bill as published. I wonder to what extent the Minister or his officials from the Department saw fit to meet the principal organisations that might have a role in this area such as the National Drugs Advisory Board or the College of Physicians to get their views in advance of the publication of the Bill rather than going through an unnecessary and labourious debate which this obviously has to be, although I accept their reasons for the need for statutory control. We might have tested these areas a little bit more minutely than we did prior to the Bill being published.

The Minister is probably aware that to add to the area of consultations I mentioned, a number of Fine Gael Senators who have been interested in this Bill asked the Leader of the House whether it was possible to meet the Minister in advance of today's debate — just in case he thinks we are saying things to him today because we are irritated with the Bill. The response we got from the Department of Health was zero. There was not a single response from the call from the secretary to the Leader of the House to the Department asking for a meeting with the Minister. I look forward to the Minister's response to the debate. I, with my colleagues, will reserve opposition on this Bill until we know where we are going and to what degree the Minister is prepared to amend a Bill which in principle is a very worthwhile and important step but which seems to have struck the wrong note in a number of areas and caused unnecessary apprehension to those involved in the area of medical research.

I welcome the Bill. I am very pleased that an attempt is being made to see that the ethics committee proposed in the Bill are given sufficient scope to be vigilant in ensuring that risks to the people partaking in the trials do not outweigh the objective of the trials. I know it is very tempting for any unfortunate down on his luck to take advantage of these trials, especially somebody who is suffering from the disease involved in the trials, but they must be given every possible protection. The Minister has gone quite a distance in this regard. I do not believe that the ethics committee will be able to monitor the behaviour of all the drug companies. We have only to look back over the years to see some terrible abuses of drugs, not only in Germany but in the USA and other places. Because of this the ethics committee will be more on their guard than ever before to make sure that the public get the protection to which they are entitled. The Minister and his advisers have made a genuine attempt to protect this area.

It is also encouraging to see the guidelines that will be drawn up for the information of applicants. This is very important because I would not like to see the Minister interfering too much. This matter is so delicate that one would not quibble with the Minister intervening. This is an area that is of vital importance to the health of the nation and it is necessary to show the public that everything is being done to protect people who might offer themselves for drug tests.

The fact that the Minister has control over the composition of these committees does not guarantee that one is not going to get a bum steer somewhere. There is no committee that does not have one or two duds or awkward people. That risk is there. Having said that, the guidelines in the Bill will give that measure of protection to people. Human beings are human beings. If a tyrant is emptying a bin and is shifted and made a director he will still be a tyrant. One can get caught in committees the same as everything else. If one brings a guy in he might go to great lengths to get his own way. To a great extent we must admit that the guidelines help to circumvent the effects of anything that might go wrong in the ethics committees. I am confident that everything possible will be done in this area and it is good to see that because the public have a right to make sure that these committees are not only independent but competent as well. There is no point in having them independent if they are not competent. Consequently, this is a vital aspect to the Bill. The way the Bill is framed will help it to work towards the question of both the independence and the competence of the people concerned.

It is not relevant at this stage but it is very important because of the very nature of the Bill that we are not going ahead with Committee Stage today. This gives an opportunity to anybody who has any misgivings about this very delicate area to put down amendments and to have much more detailed discussion on Committee Stage. That is essential and for that reason I am pleased we are not rushing into Committee Stage today. We could be in serious trouble if we did so. In fairness to the Opposition, whether we agree or disagree it is of public interest. We are talking about the health of the nation and the drugs that can wreck our children. In the final analysis we have only to think back to the thalidomide problem to realise the gravity of this area. Consequently, every possible opportunity should be afforded to the Opposition or anybody else to put down an amendment. I am sure the Minister would welcome that.

The Bill goes a long way in regard to giving information to applicants for drug testing. I feel it will be comprehensive enough for them to be able to form a judgment for themselves as to whether the trial will be conducted properly. This can be of assistance not only to the public in general but also to the applicant.

In section 8 the written consent of the applicant and his right to withdraw are important. Prior to this they had to give written consent. I am not quite sure about that, but I imagine that would be normal. But it is now written into the Bill that he would have to give written consent and would also have the right to withdraw from tests at any stage and that is a very good clause to have inserted. The Bill will give people who are unable to give written consent or do not understand the nature of consent a measure of protection. It is interesting to note that they will not always be used. If somebody cannot give written consent and does not understand what is going on there would be a reluctance on the part of the people doing the trials to take those people in and that is a very desirable thing because many old people who left school at a very early age, while they may be able to read the Evening Herald or the Evening Press would not understand the full implications of what they were being asked to enter into. There is plenty of illiteracy even in this modern day of so-called free education. It is wonderful to see that somebody has looked at that and is making sure that nobody enters into something he is not fully competent to understand. I know the analogy is not great, but it is a pity a clause like that was not in some of the hire purchase Acts many years ago when people were taken to the wall.

The question of the declaring of submissions is an interesting one. That has been in existence for years. I think what the Minister meant in his Second Reading speech was that the submissions fell short and that something much more effective will have to be done in regard to the question of submissions when we are talking about comprehensive control over the trials. I hope I have read that correctly.

We have had media attention given to the death of that poor, unfortunate person. Even though it was a drastic thing to happen I do not believe the people who were conducting the trials at the time were incompetent. I believe it was just one of those things that happen. But we have to think in terms of the fact that we are talking about the involvement of humans. No matter how we go about it, it must prompt action and it has prompted action not only here but on the international scene. There is the question of principles. Once there is a death like that, one has to think seriously about the principles involved and whether in fact we were wrong all along not to have legislation to control the conducting of clinical drug trials. It was wrong because we had enough information about the disasters that happened years ago not only here but in other countries with regard to drugs clashing with other drugs. That is a very serious area. The Council of Europe have ben working on formulating principles on medical research in man. This is interesting and I would like to see more research not only into drugs but into the motives of people who are subjecting themselves to these trials. I do not want to keep referring to the thalidomide tragedy. It was a quarter of a century ago. It is distressing to look at the people who are victims, those who are caught up in the scene. It is upsetting to look at a child who has lost limbs or is disfigured in some way. This whole messy thing has gone on for many years and the victims did not get what I would consider to be adequate compensation, justice or anything else. Of course no money would compensate a person if something went wrong.

It is tremendously important that all aspects of clinical trials are covered in the legislation. I have no doubt that any reasonable amendments put forward by Members will be accepted by the Minister because he realises the gravity of the situation. Had time permitted I would have quoted an extract from a book I read some years ago about the abuse of drugs in the US. According to that book such abuse took place in institutions. It was frightening to read the disclosures in it. I do not know if the author was on the ball but he was not sued and I found that very interesting. This is a serious issue particularly when one considers the evidence of the harm that can be caused to people.

Debate adjourned