Control of Clinical Trials and Drugs Bill, 1990 [Seanad ]: Second Stage.

I move: "That the Bill be now read a Second Time."

I am pleased to bring this Bill before the House on behalf of the Minister for Health. The Bill was fully debated and passed by Seanad Éireann where it received wide support and was welcomed by all parties. The purpose of this Bill is twofold. First, it is to amend the Control of Clinical Trials Act, 1987, to deal with difficulties which have arisen in the operation of that Act, particularly in so far as it relates to the responsibilities imposed on ethics committees by the Act. Secondly, the Bill seeks to provide certain legal immunities for the National Drugs Advisory Board in relation to the functions imposed on them under Article 4 of the National Drugs Advisory Board (Establishment) Order, 1966.

The Bill is necessary in order to overcome obstacles which have adversely affected the effective operation of the 1987 Act as a whole and which threatens to seriously limit clinical research in this country. Because of the difficulties being experienced, the Minister for Health established a working party, which was representative of the pharmaceutical industry, clinicians and the Department of Health, to review the workings of the Act and in particular to see how the obstacles being experienced might best be overcome.

The recommendations of the working group have been taken fully into account in the preparation of the Bill now before the House.

Particular difficulties have arisen for ethics committees from the obligations imposed on them by section 10 of the Act which obliges the committees to satisfy themselves in relation to the adequacy of the financial arrangements made to compensate those who may suffer injury or loss as a result of participating in a clinical trial. Legal advice obtained by a number of hospital based ethics committees has highlighted the potential open-endedness of section 10 and suggests that the burden placed on ethics committee members in assessing the adequacy of compensation arrangements leaves such members open to being sued for negligence. Most hospital based committees have accordingly either stepped down or are only giving consideration to trials on products which have licences and which are in current use, with the result that hospital based trials on new products have virtually ceased.

I am therefore proposing the removal of this particular obligation from ethics committees by amending section 10 of the Act as provided for in section 3 of the Bill. The amendment will require that a person shall not either arrange for the conducting of a clinical trial nor conduct a clinical trial unless that person has first established to the satisfaction of the Minister for Health the adequacy of the arrangements for security to compensate persons who may suffer injury or loss as a result of their participation in a clinical trial. The amendment will, while removing the difficulties experienced by ethics committees, at the same time ensure that there will be adequate security to provide any compensation to participants that may become necessary.

While dealing with the particular problems of ethics committees I have taken the opportunity to further amend the Act to deal with two other minor matters which require further definition or clarification.

Section 6 (2) (a) (ii) provides for an exemption from the definition of a clinical trial and thereby from the controls set out in the Act of a trial where the principal purpose is the welfare of the patient.

In the light of the operation of this subsection, it has transpired that, as worded, there is scope for a fairly broad interpretation of what is intended. Clinicians involved in clinical research sought clarification on the intention of the section and so I propose in section 2 of the Bill to amend section 6 of the Act so as to state clearly the aim of the section and specifically to exclude trials where the intention is to prevent disease in, or to save the life, to restore the health, alleviate the condition or to relieve the suffering of the patient. The amendment, which will set out clearly and unambiguosly the intention of section 6, was prepared in full consultation with parties involved in this area of research. It will also provide a useful tie in and ensure consistency with the provision of section 9 (7) of the Act which provides safeguards for patients who are participants in clinical trials.

I also propose by section 4 of this Bill to amend section 13 of the Act which deals with offences and provides for defences in relation thereto. There is a need to provide appropriate defences for unincorporated bodies such as ethics committees and the purpose of the proposed amendment is to bring this about.

It is necessary to provide certain legal immunities for those parties involved in administering the Act, in particular the ethics committees in relation to their functions under the Act. I am also proposing an immunity for the Minister for Health in relation to the Act and I am taking the opportunity to deal with the liability of the National Drugs Advisory Board under this Act and in relation to their functions under Article 4 of the National Drugs Advisory Board (Establishment) Order, 1966, and for committees established under Article 18 of the same order. The provision of such immunity is a well established feature of legislation and there are many precedents for it.

The members of the National Drugs Advisory Board, who are appointed by the Minister for Health, are leading specialists in the fields of medicine, pharmacology, toxicology and other related disciplines and provide their services free of charge. Over the years concern has been expressed by members of the National Drugs Advisory Board with regard to possible legal liabilities which may fall upon them as a consequence of their membership of the board and they have sought an appropriate indemnity. The matter was referred to the Attorney General for advice. The Attorney recommended the provision of an immunity as set out in section 5 of the Bill. Similar immunity has been granted to other State boards, including EOLAS, formerly the Institute for Industrial Research and Standards, and the National Health and Safety Authority set up last year by the Minister for Labour. In order to ensure the continued participation of specialists of the highest standing as members of the board and their specialist committees and thereby maintain their internationally recognised status the Government consider that it will be necessary to provide an immunity along the lines which I now propose. The Attorney General considers the proposed Bill to be an appropriate vehicle in which to provide this immunity.

The Control of Clinical Trials Act, 1987, was a prototype piece of technical and complex legislation. In such circumstances initial teething problems were always a possibility. At the same time the Government were committed to keeping the operation of the Act under review and to deal with any difficulties that arose.

The amendments now proposed will overcome the difficulties being experienced and thus restore Ireland's position as a favourable location for clinical research, thereby ensuring the objectives of the Act to facilitate research and to protect participants in clinical trials are fully realised.

I commend the Bill to the House and look forward to this Second Stage debate on this very important legislation.

I welcome this Bill. I regret it has taken as long as it has to get to the floor of this House. I think I am right in saying that the Minister for Health promised in December last that it would be introduced in a matter of weeks, but I am pleased that we have had an opportunity before the Dáil goes into recess to try to enact this legislation — it has gone through the Seanad — because a great degree of urgency is involved in this Bill. For that reason we have agreed to the time constraints and my contribution will not be excessively long. We hope to take in all Stages if possible this evening. I am aware also that there were delays with the Attorney General's Office.

We are amending the Control of Clinical Trials Act, 1987. Fine Gael did not oppose that Act at that time. However, amendments were tabled, and I have a copy of the speech made on 18 June 1987 by my party's spokesperson at that time, Deputy Mary Flaherty. She said that the Bill as currently drafted was so seriously defective that it could have the opposite effect from that intended. A provision in the Bill related to ethics committees and insurance would drive research out of the hospitals entirely and exclusively into the commercial private sector. Research into some terminal illnesses and cancer would have to cease as insurance was simply not available here.

She went on to say that section 10 set out the requirements for adequate insurance for compensation. On the surface it was a straightforward and worthy requirement. However, it was not possible to get insurance for research into certain sensitive areas such as work with the terminally ill or with cancer patients. Since the publication of the Bill, Irish doctors had made inquiries and found that cover would not be provided. Therefore, the net effect of the Bill was that research in our hospitals in these areas would cease.

I regret very much to inform the House that this is exactly what happened, and I regret that the advice given at that time by the Opposition was not heeded. However, I accept that there should be a legal and statutory basis for clinical trials to protect the participants in those trials. Prior to the 1987 Act we had simply guidelines on a voluntary basis operated by the National Drugs Advisory Board. In this we must seek a balance between protecting those individuals and ensuring that the bona fide legitimate testing of drugs that needs to take place prior to their marketing stage can be carried out to make them safe.

We are aware of the tragic death of Niall Rush in 1984 which perhaps resulted in this legislation being introduced and of the thalidomide cases all of which highlight the potential dangers when there is not a proper safeguard in place on a premarketing basis for such drugs.

However, the principal reason the Act failed was that section 10 of the Bill virtually halted research, not in commercial institutions, not in the Institute of Clinical Pharmacology, not in the Elan Corporation, but in our teaching university based hospitals. There is a number of cases in relation to the Mater, St. Vincent's and St. James's hospitals where the ethics committees were not prepared to take the responsibility for liability in respect of participants in trials that they were obliged to do under section 10 of the Act. This led to a number of pharmaceutical companies, who were prepared to underwrite and pay for the research and the liabilities, relocating their research in the UK simply because ethics committees were not prepared to oversee and take responsibility for these research projects.

There was also the difficulty that the administration of some drugs was not available because it would have involved participation in an open clinical trial. I am referring to the most publicised case, to AIDS patients attending the GUM clinic at St. James's Hospital under the care of consultant Fiona Mulcahy. As we know, there is no cure for AIDS and the development of treatment and cures for AIDS is an ongoing thing. The most established treatment is AZT; but, as we know, some people have a very server reaction to AZT and cannot take it. Those people can only take DDI or DDC. My understanding from patients is that they have had to travel to England surreptitiously in order to get this treatment because they would have to participate in a clinical trial here and the ethics committees do not oversee such clinical trials. That is one reason why I am glad that this Bill is now being dealt with.

Commercial research was not affected but when replying on Second Stage I would like the Minister to make some comment on the collapse of the Institute of Clinical Pharmacology. There is a public perception that the difficulties relating to the Clinical Trials Act are coincidental with the collapse of that institute. As the House knows, it was a very spectacular collapse in that it was a world leader. The Minister might give his reasons why they collapsed and he might tell us what steps he is taking to maintain a high level of research here. If those carrying out research in our hospitals cease their programmes, they will very quickly lose contact with their international colleagues carrying our research and we will quickly become isolated from the latest developments in medicine, pharmacology and so on. If we are to keep in touch and develop the most modern therapeutic procedures, research here must be on a par with what is available abroad.

Section 3 of the Bill deals with shifting the liability to have security from the ethics committees. The main purpose of this section is to scrap the original section 10 of the Act. According to section 3, the Minister will have responsibility and he must be satisfied that everything is in order before a trial can be held. The Bill does not state what circumstances will be necessary to satisfy the Minister. Would a bond of £100,000 be satisfactory, or a bond of £1 million? What are the exact requirements to satisfy the Minister? Will the Minister give details of the guidelines he intends to introduce that will satisfy him in order that clinical trials can be carried out?

In section 3 we have a new paragraph which says:

(5) In this section ‘security' includes a contract of insurance, a contract of indemnity, a guarantee, a surety, a warrant and a bond.

Does the Minister intend that it will be insurance, a guarantee, or just a letter of comfort, or will it be a bond that one would have to buy with a cash value? It is unclear from section 3 exactly what is intended here. I would prefer if we adopted the system which operates in the UK whereby the pharmaceutical company underwrites the research and is responsible for the insurance, with the clinical researcher carrying out the work; and, as the Department of Health and Social Security do in Britain, we should when things go wrong provide for anex gratia system of payment, quite separate from compensation, for the people involved.

Section 5 of the Bill deals with immunities. I am not against what the Minister has said in relation to the long campaign for immunity in relation to the overall work of the National Drugs Advisory Board. But in this Bill the original Act is being reformed in such a way that the Minister carries the can. The Minister oversees the trials, the Minister gives the approval for the trials and he must be satisfied that the security is there. But then we see in section 5 that "No action or other proceeding shall lie or be maintainable" against the Minister. If there is a cock-up in the NDAB or in the Department or if the Minister makes a mistake and in error grants permission for a trial, what opportunity is open to the participant who is seeking redress to get that redress? He cannot go to the Minister or to the NDAB. What safeguards are there? Does section 5 of the Bill undermine the original Act? In what circumstances can an aggrieved participant pursue any claim? If the cover was for £100,000 and it was found that the insurance policy had run out a week earlier or some small print had not been observed, what redress would apply if everybody is immune as outlined in section 5? It is important to establish these matters in this House. While we are all in favour of dealing with this matter expeditiously in this House we want to get it right this time, having done a bad job the last time.

When reading through the debates of March 1987 a question in relation to insurance was raised but not answered.

As we know, every doctor and clinician has insurance cover under the Medical Defence Union or the Medical Protection Society. It is very costly and can run up to several thousands of pounds. Does the standard insurance cover cover clinical research? If the person carrying out the research makes a mistake in administering the drug or carrying out the trial, where a claim arises, is insurance cover available and what, if so, would it cost? It is very important that the Minister initiates discussions with the medical profession, clinicians, their representatives, the Medical Protection Society and the Medical Defence Union to be absolutely sure that the clinician carrying out the work is covered.

There is a number of other points I would like to make. It is nonsensical that separate ratification procedures for each new drug are applied in each of the 12 member states of the EC. Almost 13,000 drugs, comprising 300 basic products, derivatives and variations, are being administered in the world today. It is absolutely incredible that each of the tests the Minister outlined is repeated in each country. Surely the most sensible thing to do is for the countries to adopt a common approach whereby once an EC centre approves a drug it will be approved in each member state. It should not be necessary to repeat the process in each country. There should be just one clearing house situated somewhere in Europe, in Ireland perhaps, to carry out the tests on an agency basis for each of the countries. If this was done a saving would accrue and new drugs and treatments would be made available more quickly to the public. As we are all aware, one of the difficulties encountered in relation to the patenting of generic drugs is that it can take up to six or seven years to get the drug on the market. If a streamlined procedure was adopted the work done by the NDAB could be carried out at a central EC centre. Some months ago I suggested in the House that we avail of the opportunity afforded by our Presidency of the Community to pursue that point.

In different circumstances I would table amendments to the Bill, but I will not do so on this occasion. However, in relation to sections 4 and 8 of the Principal Act, I have been told that delays are being encountered. Section 8 states that, where the Minister is satisfied that a proposed ethics committee for a clinical trial is competent to consider the justification for conducting the proposed trial and the circumstances under which it is to be conducted, he shall give his approval. It gives no indication of what time limit applies. For instance, it does not state that he must give his approval within 12 weeks, four months, six months or a year, with the result that delays are encountered. Now that the Minister is being given a more central role in approving the security arrangements, we should insert a time limit.

Section 4 of the Principal Act states that the National Drugs Advisory Board shall, not later than 12 weeks after the application has been made, grant permission or not as the case may be. I feel that that is too long and they should give their decision within six weeks.

Who is going to decide on who should be appointed to the ethics committees? Will it be the hospital, the Minister or the drugs companies? I ask the Minister to reply to those questions.

In relation to section 2 of the Bill, which deals with the definition of "conduct for clinical trial", normal clinical practice is now being excluded. What I would like to know is whether this means the administering of drugs such as new leukaemia, terminal cancer or AIDS drugs will be excluded, as I feel they should? Surely this amounts to treatment rather than experimentation. I am not clear from the table included in the Bill whether these are covered or not.

The Minister has proposed in section 4 of the Bill that the words "or by a person purporting to act on behalf of a body corporate" be included in section 13 of the Principal Act. I would like to know the Minister's reasons for including these words. Is it his intention to try to close a loophole which people have found in the legislation to evade their responsibilities?

In conclusion, I welcome the Bill and will do all I can to ensure it is enacted as speedily as possible. I ask the Minister when replying to deal with the question of immunity and to outline what security requirements will have to be complied with in relation to bonding and insurance. I will scrutinise these on Committee Stage.

I have no doubt that, as late as last night, the spokespersons on Health of the various parties did not expect to find themselves on the floor of the House this evening discussing this legislation. Given the uniqueness of the legislation and the desire of all parties to have it enacted as speedily as possible, time was allocated to take the Bill. As the Minister said, it is amending legislation aimed at resolving the difficulties which have arisen since the Principal Act was passed in 1987. For this reason, and to facilitate the Minister in enacting the Bill, I will not try to obstruct him in any way.

One of the objectives of the original Bill was to introduce regulations and controls into an area about which a great deal of concern was expressed at that time. Any research involving people results in a certain unease among the general public. The original Bill was introduced against the backdrop of events and, of necessity, was complex and innovative. At that time people predicted that difficulties would arise. A large number of amendments were tabled to the Bill, some of which were accepted, but few people believed when the Bill was passed that that would be the end of the story. One of the points made on the Second and Final Stages was that the implementation of the Bill would have to be constantly monitored.

Difficulties have arisen which are the source of disquiet among the medical profession and those of us interested in the proper conduct of medical research and innovative practice. The Minister for Health confronted these difficulties when they became obvious and established a working party to review the workings of the Act. The findings of this representative group, which was comprised of distinguished specialists in various areas, led to publication of the Bill we are discussing tonight.

In his contribution the Minister of State dealt with the specific difficulties which have arisen. Section 10 of the Principal Act imposes obligations on ethics committees. However, these obligations have led to such committees either standing down or abandoning clinical trials on new products. There is a clear need to carry out research. Therefore the problems which have arisen must be addressed and rectified.

The whole area of drug research, particularly that involving people, is an emotive one. The original debate was an emotive one. More than anything else the single factor that led to the former Minister for Health, Barry Desmond, initiating the Clinical Trials Act was the sad death in 1984 of Niall Rush. That caused a degree of public outrage and there was a debate among the obviously conflicting interests about advancing medical knowledge and the taking of risks with people. Any such risks must be reduced to a minimum.

It was clear that a legislative framework had to be established and put into place to protect all volunters for clinical trials. It is clear also that that legislative framework could not be so restricted as to preclude the undertaking of further clinical trials. While I, therefore, accept the need for the legislation before us tonight, in normal circumstances, I do not think I would have accepted the urgency with which it is being processed. I would like to have had a longer time to prepare for the debate and longer time allocated for speakers.

The urgency has arisen by virtue of the fact that certain drugs, which were on offer from pharmaceutical companies, to certain categories of patients, particularly patients who have Acquired Immune Deficiency Syndrome, most particularly DDI, are not available. AZT, which is the most common treatment currently used for AIDS patients, has not proven suitable to treat all cases. While it is recognised that there is no cure for AIDS we must strive, as a matter of urgency, to seek whatever preparations are available to either arrest the development of AIDS and the debilitating side effects, or we must strive harder to seek a cure because, no doubt in the fullness of time, medical science will advance to the stage where we can have a cure for this terrible disease.

All of us in this House, mindful of the difficulties that face patients such as those I have referred to, have a responsibility to respond in a speedy and effective way. Clearly drug treatment is not a total answer to AIDS or to any other condition. Frequently when we are dealing with debates such as this, we can arrive at a situation where we feel that the obtaining of new preparations, new drugs, new treatments, wonder drugs, will solve all our problems. I would not like to convey that view because I am of the view that the answer to a healthy people and the treatment of many illnesses is often a matter of environment and ethos as much as any particular preparation that is administered. In this country the ethos and tradition we have of caring for and supporting the sick and the handicapped is a very positive one. It contributes very much to the whole notion of a productive and proper life. Probably we have a less stressful society than many others in the western world and that should not be lost sight of in the whole debate on health. Notwithstanding that, there is a responsibility to address the fundamental issue of allowing medical research to continue in a controlled and responsible way but not to be so circumscribed as to be totally ineffective.

In the past and, indeed, during the debate in the Seanad and also in the debate on the Principal Act, much comment was made about the morality of clinical trials on people. The defence against the charge that such trials are immoral is often given as the element of choice: people have free will and they can present themselves for such trials or not; they can decline to undergo such trials. The reality is that if you look at the profile of those who actually volunteer for clinical trials, it must be acknowledged that they do not come from the average or the above-average income group. We have to examine how much choice exists in reality for people who volunteer, because finance is certainly a major factor. The financial inducements or support given may not be of a very high order, sometimes in the range of £25 per day or, perhaps, £200 or £300 for a total course of trials. While that may not appear to be a great deal of money for many people, for people on marginal incomes it can mean a great deal in improving their quality of life. Unfortunately, many people are still enticed into making an economic choice for themselves. That is something that needs to be addressed and it is not something that rests lightly on me.

It would be nice to think that there would be an element of civil duty or responsibility that would motivate people to volunteer as part of the national good. Sadly, economic necessity appears to be the prime if not the exclusive motive for many healthy people volunteering to undergo clinical trials. Although it is an issue that is not directly addressed in this legislation it is very much a significant backdrop to the whole debate. Therefore, testing can be carried out only where there is a real and clear need or clear and unambiguous choice on behalf of the volunteer. This was certainly the motivating factor in the original Act. While we found that the original Act needs to be amended, it was innovative and one that was needed and demanded by the public at the time.

Deputy Yates referred to the collapse of the Institute of Clinical Pharmacology. It is an interesting fact that that highly prosperous institution which was making very substantial profits did collapse. Many people attributed the difficulties of the Control of Clinical Trials Act, 1987, to the demise of the Institute of Clinical Pharmacology. It would be worthy of comment — I do not know whether the Minister would deem it appropriate — on Second Stage to make a clear statement on it so that the confusion on that issue would be lifted.

The specifies of the Bill are straightforward. Many of the point made by Deputy Yates are worthy of response, two of which I will focus in on. The first is that section 3 of the Bill, which changes the old section 10, now gives the responsibility to the Minister for establishing to his satisfaction that there is available security to compensate persons, etc. It would be useful if the Minister had drawn up regulations — I presume he has worked on them — to know exactly the criteria that would satisfy the Minister under this section, should it be enacted. It would be useful if we knew that in advance of proceeding to the Final Stages tonight.

The other factor is in relation to the immunities proposed in the Bill. The Minister suggested that broad immunities are proposed in section 5. He said they are in accordance with immunities offered to various other semi-State and State organisations and are drafted in accordance with the criteria laid down by the Attorney General. If the Minister is taking responsibility unto himself, who is left to carry the can ultimately, since the Minister and the National Drugs Advisory Board are given fairly broad immunity under section 5 should its provisions be invoked? It should be made clear that somebody is responsible. There should be no ambiguity about it.

I have said that this Bill is necessary, but that it is an unusual procedure we are adopting this evening. There is one hour of scheduled time remaining in which to conclude this debate. There are many others wishing to offer on Second Stage and the remaining Stages have to be passed before the night is out. Therefore I will endeavour to encapsulate my thoughts in a few sentences. First, let me say that I would not normally support this procedure. It is not good procedure that Committee Stage should immediately follow the conclusion of Second Stage. But I suggested last evening, and for once my position as a party Whip enabled me to ensure, that time which is extremely scarce, be allocated to this important Bill. Hopefully it will be enacted before the end of this session.

I welcome this Bill recognising on the part of The Workers' Party the need for amendment of the 1987 Act. The Minister will be aware of the contribution of our colleagues in the Seanad. I do not want to repeat much of what they had to say; nonetheless it made interesting reading. I might take up some of the points made in the Seanad and some made in the House this evening in an effort to seek some assurance from the Minister.

It is worth casting our minds back to the reasons that rendered the control of clinical trials so important in 1987, leading to the introduction of the Control of Clinical Trials Bill of that year. Indeed it is incredible that to date we have not devised appropriate legislation to control what takes place in the course of clinical trials. Unfortunately, in 1984, it took a public outcry to raise the consciousness of politicians and others that these horrendous tests were being carried out in our city. At that time it was probably news to many people that there were people subjecting themselves to the injection of all sorts of drugs being tested. That outcry arose as a result of the tragic death of Niall Rush, leading to the understandably hurried legislation introduced in 1987, now found to be faulty or deficient. If my memory is correct Niall Rush's father said in the course of radio interviews that if anything could be learned from the unfortunate death of his son, then he could rest assured that the same circumstances would not recur, that people subjecting themselves to such clinical tests in the future would not be as vulnerable as was his unfortunate son.

At the conclusion of his remarks this evening the Minister said:

The amendments now proposed will overcome the difficulties being experienced and thus restore Ireland's position as a favourable location for clinical research, thereby ensuring the objectives of the Act to facilitate research and to protect participants in clinical trials are fully realised.

Similar words were used in the Seanad. Other Senators said it was important that Ireland be seen internationally as a favourable location for this kind of research. I would advise some caution there. Are we to be the forerunners of clinical research on human beings? The notion that this should constitute a leading industry presents me with many personal problems. My reason for having those reservations is that the raw material involved in such research is comprised of human beings. Unfortunately it is also true to say that such people tend to be representative of a socio-economic sector, usually poor people. There is a moral issue which must be addressed in all of this if we endeavour to boost ourselves as a nation having all of these facilities for clinical testing. I contend this is not an image we should endeavour to portray by way of incentive to the location of other institutions here, institutions such as the Institute of Clinical Pharmacology. We must question the whole moral issue of encouraging huge institutions specialising in recruiting human beings for such tests. I contend it carries sinister undertones, poor people being attracted by rather meagre payments of say, £25 per day in order to subject their bodies to dangerous or, in some cases, fatal tests. It is ironic that that sum of £25 is exactly similar to the amount we TDs receive by way of subsistence allowance. When one compares that with other sections of the community so desperate for money to sustain themselves and/or their families that they will subject themselves to these dangerous tests, then there is an absolute responsibility on us to guarantee, in so far as such is possible, that safeguards are built into the relevant legislation, with financial safeguards in the event of unfortunate people becoming very ill, disabled or even dying as a result of such tests.

How long should the health of somebody who has subjected themselves to such tests be monitored? I would argue that the side effects of some of these tests may not manifest themselves within a month, a year, even two or five years; such side effects might not manifest themselves for very much longer.

Section 3 (5) reads:

In this section "security" includes a contract of insurance a contract of indemnity, a guarantee, a surety, a warrant and a bond.

That begs the question: how long will such insurance obtain? Can the Minister say what would be the insurance liabilities in the case of somebody making a claim? What type of guarantee would obtain if somebody suffered some tremendous repercussions having engaged in this type of testing or research? Also what type of security would obtain for that person and his or her family? For example, such a person might have had no family responsibilities at the time of subjecting himself to such tests but ten, 15 or 20 years later his whole lifestyle might have changed dramatically, when he could then be a married man with considerable family responsibilities. What type of insurance coverage is there that will safeguard him and his family?

The Workers' Party, however, restate our objection to commercial drug testing with private companies making profits on the backs of these testers. As has been pointed out, there are over 15,000 drugs which can be prescribed to patients already available, and the World Health Organisation estimates that all medical eventualities would be covered by 300 drugs. They are startling facts and figures. However, one could not deny the fact that there is need for continuing research. Most of us would agree that AIDS is a relatively new medical phenomenon and we must, therefore, seek new drugs to fight it.

The moral question, however, is: who is to carry out such testing? When one passes over the responsibility to multinational corporations who will either do the research themselves or have other big companies do it and produce drugs to be marketed by other companies, quite clearly what is being engaged in is private enterprise seeking a market for profit. Is it wrong? One could hardly say it is totally wrong, but there is the question of whether institutions other than private enterprises should carry out the research.

The whole area of drug testing requires the most careful controls with the emphasis on establishing whether it will prevent disease, save lives or relieve the suffering of patients. There are however strong commercial links between those involved in running clinical drug trials and those that manufacture the drugs. The clear emphasis in drug trials must be on the need to achieve greater medical understanding and advance rather than putting large sums of money into the pockets of already wealthy individuals and companies.

In essence, our arguments are that stringent safeguards have to be established. The priority must be to give as much security as possible and lessen the temptation to attract the very poor, who seem, in the main, to be the people who subject their bodies to tests. We might look very carefully at how we can break ourselves away from the exclusive subjection of the poor to tests and make testing more attractive to a broader section of the community.

I will leave it at that for the moment. I will certainly be interested in getting some explanation in regard to insurance coverage, the duration of the coverage and the type of coverage available under these insurance policies.

I will make only a brief intervention because we all want to make progress. It gives me no pleasure to say that we told the Minister so, but we did indeed tell the Minister that he would have a problem with this Bill when we were discussing it in the past. The reason consultants have a reasonably generous time arrangement in their contract is that it is expected of them that they engage in research relating to their specialties for the benefit of their patients, for the benefit of medicine in Ireland and for the benefit of medicine worldwide. While the Minister's legal advisers suggested to him that there would not be problems with insurance, the advice to the consultants from their Medical Defence Union was that they would be inadequately protected.

It has taken the crisis of AIDS patients requiring experimental drugs to bring this before the House in such an urgent fashion. Since this Bill became operational theIrish Medical Times has heralded the decline of research here. There is a reluctance to engage in research, which we have lost to other countries. While we are responding in a particular way, I am not satisfied that we have responded adequately.

On the last occasion we urged the Minister to set up a no fault compensation fund which would give general cover, and I believe that is included in the provisions here and would be of great assistance. This is something we will have to continue to monitor. We debated it adequately and we realised that this Bill had to be a question of checks and balances. We were breaking new ground. We are the only country that legislates for volunteers engaging in testing. There are certain regulations in Britain within hospitals for tests on patients, but in the context of volunteers we were breaking new ground and there is always a problem when pioneering. There was the question of trying to get a balance between protecting those who were participating in trials and insuring that sufficient research was done. We obviously have not got the balance quite right yet. There is certainly a view that the changes here will improve the situation and therefore we will be supporting them. I hope the Minister will undertake to keep a very close watch on this area and be responsive to further needs for intervening in this area again.

I would like to ask the Minister a brief question.

Deputy Byrne, you do appreciate that we will be coming to Committee Stage and dealing with it, section by section.

First, I would like to express my gratitude to the House for taking this Bill at this time and particularly to the Deputies who have contributed — my colleague, the Minister of State, Deputy Treacy; Deputies Yates, Howlin, Byrne and O'Flaherty. I welcome the broad support for the Bill.

As I stated a number of times in this House, the Control of Clinical Trials Act, 1987, was a prototype piece of complex legislation and in those circumstances teething problems such as those we are now dealing with are always a possibility. The Bill now before the House will, I believe, deal effectively with these problems which have arisen in the operation of the Act. It will deal particularly with the difficulties caused for ethics committees. It will enable the committees to fulfil their roles effectively and with confidence. I am confident that the measures contained in the Bill and supported by Deputies will restore confidence in Ireland's position as a favourable location for clinical research; and I am sure that the original twofold objectives of the Act, namely, to facilitate clinical research while at the same time affording protection to participants in clinical trials, are fully realised and implemented. At the same time, the working of the Act, as amended, will continue to be closely monitored and kept under review; and I am prepared, should the need arise at some future date, to further amend the Act in the light of the ongoing experience of its operation.

A number of points were raised. Deputy Yates raised the time limit in the 1987 Act. Section 2 of the 1987 Act lays down the time limits under which applications for clinical trials can be assessed by the National Drugs Advisory Board and approved by the Minister for Health. These limits were drawn up at the time on the basis of experience of clearing applications under the voluntary system that was in operation. There is no indication that the time limits are proving a hindrance to the development of clinical research in this country. Most applications are cleared well within the time allowed in the legislation. Some problems have been encountered by the Department of Health and the National Drugs Advisory Board in relation to applications made and the response to queries raised. Inadequate responses seem to delay consideration of applications, but still the time limits were adhered to by the Department of Health and the National Drugs Advisory Board. However, I am keeping the operation of the Bill, including the time limits, under review.

Deputy Yates also referred to the criteria for security. The assessment of security has been transferred under this Bill from the ethics committee to the Minister for Health. The Deputy is correct when he says that the nature of clinical trials will require an assessment of the level of security on a trial by trial basis. The nature of the trial and the participants involved will have to be examined in this context. It has been necessary to obtain the advice of actuaries and biostatisticians towards this end.

Under section 3 (5) of the Bill I am simply suggesting some of the types of security that would be obtained. It is not an exhaustive list but is designed to clarify that insurance is not the sole type of security required. This needed to be clarified on the basis of questions posed by applicants. In response to Deputy Yate's question, I would be happy with the type of arrangements which operate in the UK under which the pharmaceutical companies underwrite and indemnify clinical research and the clinical researchers are protected through insurance, bonding, warranties and so on. This type of security applies in this country also. I deliberately did not propose an exhaustive list; indeed, if other forms of security are proposed and considered acceptable, they will be approved. In adopting this approach I was conscious that I would not put in place a legal provision which might create difficulties for researchers.

As regards the Medical Defence and Medical Protection Society cover, I am satisfied these will cover the activities of doctors in relation to clinical research. My colleague, the Minister of State, dealt at some length in his opening remarks with the immunity proposals in the Bill.

At the outset, I wish to make it absolutely clear that the immunities proposed would not apply in the case of negligence by any of the persons or bodies to which the proposed immunities would apply. In this context participators in clinical trials would be in a position to seek redress in cases where wilful negligence is involved.

I take the point that the 1987 Act was somewhat ambiguous in relation to the whole question of responsibility for accidents arising from clinical research. This became clear in the operation of the Act. The Bill makes it absolutely clear that negligence in relation to clinical research will not be protected. The proposal to provide immunity is designed to strike a balance between the rights of participants in clinical research and the role of the agencies and bodies such as ethics committees and the National Drugs Advisory Board, the members of which are acting in good faith and on the basis of information which is available to them during the trial.

Deputy Byrne raised a number of points, including the duration of security and the length of the period during which participants would be monitored. In broad terms, this would depend on the trial involved. Participants would be monitored for a period considered appropriate by the investigator. It would not be possible to state precisely what an appropriate period would be; it would depend on the individual participant in the trial. I share the Deputy's concern that poor people can be exploited in clinical research. If this is shown to be the case, I will take whatever steps are necessary to ensure it does not happen.

I would say to Deputy Flaherty that this is prototype legislation, the first of its kind, and it is not surprising there were teething troubles. Before introducing this legislation we established a very small working group, some members of which are involved in research. I am glad to say that in preparing this legislation, we have taken on board everything they recommended.

Deputy Yates referred to the membership of ethics committees. Members are approved by the Minister under section 3 of the Bill on the basis of criteria set out in guidelines issued by the Department of Health. There is a perception that the Act had an adverse bearing on the operation of the Institute of Clinical Pharmacology. However, I can assure Deputies that the ICP have confirmed in writing to the Department of Health that they have experienced no difficulty with the Act. This is borne out by the fact that applications for permission from the Institute of Clinical Pharmacology to conduct clinical trials have been turned around within eight weeks of receipt, some in less than six weeks. This compares favourably with the turnaround time for the institute's applications under the former voluntary system for applications. Under the Bill the Minister has a period of 12 weeks available to him to deal with applications.

As regards the general position of ICP, I am satisfied that the extremely competitive nature of clinical research, together with the cost structure of ICP, led to the position the institute found themselves in recently. The new owners of the ICP will, of course, be subject to the requirements of the Bill and the Department of Health are in touch with them in this regard.

On the question of the European Community approving medicines, we support the development of a central European Community medicines agency. Certainly, we will be very happy to make a case for its location in Ireland. We think it is very appropriate that it should be based here and the Department are actively involved in discussions at European Community level on this subject.

Again, I would like to thank Deputies for their valuable contributions to the debate on this highly technical legislation. I know my colleagues in Opposition are anxious that the Bill would be implemented as a matter of urgency, and I appreciate very much the positive attitude that has been taken in order to facilitate the taking of all Stages here this evening.

Question put and agreed to.
Agreed to take remaining Stages today.