I welcome the opportunity to speak on this important Bill and I join with the previous speaker in wishing good luck and success to the Minister for Health and his colleagues.
This Bill was debated comprehensively in the Seanad which helped to improve it. In that context, it is right to say that the Minister at the time was extremely open-minded and flexible in bearing in mind the contributions of Senators and taking on board many of the submissions made in the Seanad and outside at the time. Flexibility and open-mindedness are not necessarily always a feature of debating and the devleopment of Bills and perhaps it may give an example to others who are a little more rigid in their approach to legislation so that real progress can be made in this House.
This is a regulatory Bill but we should not assume the State has the automatic right in all cases to intervene and regulate the normal affairs of people. Over the years perhaps we have been a little too glib in our acceptance of the plethora of Bills introduced in the House — some more important than others — all concerned with regulating activities of one kind or another. In a matter affecting public health such regulations are reasonable, or at least the assumption that there should be such regulations is reasonable. However, when a Bill of this nature is being introduced the Minister and his colleagues should spell out the reasons in principle for its introduction and explain why a regulatory mechanism is necessary and desirable. That has not been done and the Minister's speech this morning is no exception.
It is somehow assumed that the State has the right to introduce Bill after Bill into the House controlling all sorts of activities without explaining why the State feels it necessary to intervene. As a basic philosophy that should be done in future. Otherwise we will end up with a maze of expensive bureaucracy, most of it non-enforceable, cluttering the Statute Book. This all adds to a labyrinth of expensive non-enforceable regulatory machinery which ultimately comes back to the desk of the Minister without any clear overview of the role of the State visà-vis the citizen in such matters.
From the point of view of my party, there should be a clear statement explaining the obligation felt by Government to become involved. Such an obligation is clear in this case. One does not quibble with the State's involvement in introducing some form of regulation in an area which, up to now, has operated totally on the basis of voluntary codes which were enforced honourably and in good faith by the vast majority of the agencies involved in this field but which, nevertheless, caused some problems and indeed led to a tragedy in recent times. It is important, therefore, that there should be some framework of regulatory control in this case affecting the health and safety of volunteers. The major implication in this Bill is in relation to the health and safety of citizens because the benefits of such research have clear and direct implications for the health of the general public. My understanding is that control and regulation by the State in matters of this kind are welcomed by all responsible practitioners.
I am pleased to see the involvement of the National Drugs Advisory Board as a mechanism or sounding board for the Minister to obtain his views in relation to various matters. I do not mean any disrespect to the Department but I was not overwhelmed with enthusiasm at the prospect that the ultimate safety line was referral to an clearance by the Minister in relation to allowing certain tests to take place. The Minister and the Department quite often operate the science of administration as outlined in Clive Ponting's book Whitehall: Tragedy or Farce. Some people see administration not so much as an area of particular expertise but as a general science which has certain standard rules. In this case, a clear, detailed, professional knowledge of the full medical and health implications is essential and, therefore, the skill and independence of the National Drugs Advisory Board are vital to that exercise.
It would be no harm if in this and future Bills the cost of the enforcement which will be in place if the Bill is passed was made clear to the Department and the public so that we would all have a better idea of what is involved. I am talking about administration, enforcement and regulatory costs and, in this case it would be a good idea to give consideration to the possibility of asking the drug companies, most of them internationally based, to pay the costs. There would obviously be practical difficulties in enforcing that but the principle is right and I do not see why the ordinary taxpayer should foot the bill for the development of drugs, the sale of which, in due course, will make substantial profits for the companies involved. I do not believe they would necessarily be averse to paying the costs involved.
This is a timely measure. In The Lancet of 18 October 1986 the editor drew attention to the increasing number of contract companies now providing facilities for the conduct of phase 1 studies, the initial volunteer testing. He expressed concern in this regard and any review of the question of clinical pharmacology involving normal healthy volunteer subjects which fails to address this very important issue is clearly inadequate and might even be of questionable value in terms of the findings of such research. That is a very important element in this equation: it is not merely the very important question of volunteer safety but the validity of the scientific findings emerging from such research. The calibre and the parameters of such research are vital if we are to stand over the validity of what emerges from such work.
Quite clearly, the international drugs industry is in the business of major profitability. I should like the Minister to look into the area of generic drugs and, like his pedecessor, examine the significant exploitation in this area by international drug companies, sometimes, willingly or otherwise, having as their accomplices lazy medical practitioners or others to see whether the general cost of the health services in the drugs area could be reduced. It is not appropriate to go into that in detail in the context of this Bill but it is an area of public concern and, I have no doubt, of Exchequer concern.
Here too, in this area there is money and wherever there are money and profit we will have not just what I assume to be the majority of genuine people and practitioners but also the other unscrupulous exploiters who will be attracted by the possibility of making the quick buck by cutting corners and taking avoidable risks. Unfortunately, these get-rich-quick operators who are not prepared to invest adequately in personnel and facilities to ensure high safety standards will without too much trouble find cost conscious drug companies to co-operate with them. These companies will perhaps want phase 1 studies done down to a price rather than up to a standard and we all will suffer as a result. This worrisome trend is causing concern among the more conscientious and ethical clinical pharmacology institutions and to the Minister and many members of the public. Evidence has been lacking thus far that Government agencies, even those with fairly toothless guidelines, are prepared to take effective action to curb and eventually eradicate the purveyors of cheaply priced feed-and-bleed services who masquerade as ethical practitioners of medicine. This Bill may be the first step in that direction. I hope so and I hope that its enforcement is clear and not just a cosmetic exercise which is not meaningful.
Diligently monitored phase 1 studies play an indispensable role in protecting the population at large from unnecessary exposure to potentially toxic drugs. Examination of any text book of adverse drug reactions will establish beyond argument that the array of drugs available today for the treatment of disease carry with them a varying degree of risk of injury to the patient. This risk can be greatly reduced by conducting these studies initially and the benefit to the community of such trials is vast. I have no doubt that if such testing and trials were to cease the whole science of development of drugs would in itself slow down if not come to a complete stop. That is not to say that drugs are the absolute solution to health matters or necessarily the primary solution. I look forward to another opportunity in this House of developing thoughts on alternative ways of looking at some of the health care problems we have at present.
Who then should become a subject of medical research? We should at least suggest a new way of looking at this problem. Up to now perhaps the human volunteers were quite often people who were obligated by social or economic circumstances into volunteering. They were generally people who had no other way of making an income, who were unemployed, students who were hard pressed to make ends meet and people who were generally vulnerable. From every point of view, ethical, justice in society, even of public safety, this is not desirable or acceptable. Therefore, from now on we should look on this area not as somehow carried out by companies using a small category of people who are prisoners of that system, so to speak, but that all of us have to some extent a moral obligation collectively to develop higher standards in the area of drug testing. If the standards we are presenting this morning are safe, proper and comprehensive enough, what would be wrong with each one of us accepting our quotient of responsibility in the same way, for example, as we or societies do in all kinds of areas such as jury duty, paying our taxes, maternity leave for women and so on? In other words, each of us could accept that this is not something that drug companies are in the business of for the purposes of making money per se but that it is of fundamental benefit to our society and that therefore all of us have an obligation to co-operate. That would mean that each of us would see that we must take part in the development of new medical weapons with which to fight disease to save lives, that in theory it is necessary to take part in research projects. In that context and in the context of centrally regulated controls which are seen to be fair and safe we might even suggest that persons who would then be unwilling to play a reasonable part perhaps once or twice during a lifetime in helping to find new therapies from which they and their families might need to derive benefit to ease their pain and diseases and prevent premature deaths, would be lacking in commitment to society in general.
That is not the way such trials are thought of at the moment and perhaps there is a degree of naïvety about this suggestion but I think we could assist by doing one or two things. For example, it seems not unreasonable to encourage employers to give employees time off and perhaps pay them for their absence if they volunteer to help in this area. Certainly participation by human volunteers in the early stages of drug development is vital, lawful and, I suggest, morally compelling. It is also required by international drug regulatory authorities before any drug be made available on prescription. Therefore, up to now to an extent in getting the higher standards of health care that we enjoy from that element of the health services which relies on drugs and drug related therapies for qualitative improvements, we have been relying on a small group of people who I argue have generally been pressured into the business of subjecting themselves to these tests. Perhaps we owe them and society in general a debt because of that.
With a few exceptions the behaviour of a drug in the physiological normal body must be studied before its behaviour due to pathology can be established. If that is the case, why should the responsibility rest on those who have no other choice but to volunteer? Why should each one of us not say that it is in everyone's interest, that therefore we must do our part? If for any reason healthy volunteers cease to be available clinical research in the treatment of disease would not progress further. It is certain that the necessary advances in the treatment of disease will continue only if volunteers are permitted to make active contribution. In the absence of this contribution progress will cease and therapeutic stagnation will result. However, to volunteer to be a subject of medical research entails, like many other human activities, some degree of risk to life and health, therefore we must accept there are risks.
With the exception of a few special varieties of drugs the phase 1 studies are conducted in normal healthy male volunteers aged between 18 and 45 years who are not on medication and who are not excluded for reasons of drug abuse or mental incapacity. In addition to being suitable as defined by the inclusion criteria spelled out by many such companies and businesses in the protocols they use, the normal, healthy volunteer must be not only suitable but available, and that is where the crux arises. Availability constitutes the greatest limiting factor to volunteer population pool size. I would be interested to know if there are studies in the Department indicating how many people will volunteer in this area. I suspect the number is very small and they are quite often the same people over a time subjecting themselves to repeated drug testing.
We should not ask that group of people to carry our burden for too long more. Many people subject themselves willingly to volunteering blood, for example, for the purposes of the common good. Unlike the time factor involved in being a blood donor which is obviously quite short, the phase 1 volunteer has to commit time to the project which can be measured in days or even weeks rather than hours. That is a major problem. Therefore, if we are to accept that in today's society we still lack the enlightenment of regarding volunteering for clinical research as laudable, it means that volunteering for phase 1 clinical research is confined to a few social groups — students, drug firm employees, members of religious communities and those particularly for whom work opportunities do not exist and are unlikely to exist in the foreseeable future. If a civilised organised society is able to accept that its citizens are entitled to leave of absence from their places of employment for weeks or months with full remuneration to serve in the armed forces, to have babies, to have medical or surgical treatment, to prepare for the Olympic Games or to do a thousand and one other tasks which are seen to be in the public interest, is it reasonable that they might also recognise the right of the citizen to fulfil a moral obligation to participate in clinical research in this case? If so, would it be possible to extend the same parameters of conditions and flexibility in terms of on-the-job availability and so on to people who so wish to volunteer? Perhaps there might even be considered a legal requirement on employers to grant leave of absence to employees who wish to participate in clinical research. Such a privilege could be restricted to, say, not more than twice in the working lifetime — for example, once under the age of 45 and once over the age of 45. The recompense to the subject would be related to his normal remuneration for which the sponsor of the research project would be responsible.
That is not an unreasonable proposition and I would be interested in the Minister's reaction to that suggestion. The research volunteer must also be guaranteed financial protection against injury. Up to now that has been far from clear. Future legislation should ensure that a suitable and appropriate mechanism be designed and in place to protect the volunteer against accident or abuse. Obviously a cap of some kind has to be placed on the amount of money that should be awarded in those cases but that insurance should exist in the event of something going wrong.
A very important element of this issue is that there has been a very serious deficiency in the survelliance of volunteers in so far as at present there is an inability to identify all volunteers who have recently been involved in either research projects or medical treatment elsewhere. The methods of detection are never likely to be adequate to replace the absolute necessity that volunteers in their own best interest provide complete and accurate details of their previous medical history. I am not commenting on any individual cases but because of the pressure which individual volunteers may feel for economic reasons they may not be fully forthcoming with regard to stating clearly their previous medical history or indeed whether they are at that time taking drugs of one kind or another. That is a serious deficiency. I wonder whether or not the Minister will consider asking the National Drugs Advisory Board for their view on whether it might be required of each volunteer to present an up-to-date medical certificate of his health condition and whether or not he is on drugs of one kind or another. Obviously a volunteer can also lie to a doctor but this would at least be an attempt to solve an issue which is of concern and which, in the context of the present small pressurised group of volunteers that exist, is very relevant. If a person needs the money he will volunteer. If he needs the money badly he will undoubtedly be less than totally forthcoming if circumstances exist which will stop him from becoming a suitable volunteer. We should try to protect people from themselves in a case like this.
Due to the capacity of the agencies involved in drug testing to now advertise for volunteers the numbers of people volunteering are much greater than heretofore. There have also been significant changes in the socio-economic standing of many of these volunteers and that is not a bad thing. The contribution that the healthy volunteer has made in the past and can make in the future of the advancement of theraputics is inestimable. We owe such volunteers a debt because they have helped us all. It is high time that this fact was recognised by society as a whole. Some degree of the obligation implicit on all of us who are involved in development and use of drugs to ensure this recognition is forthcoming cannot any longer be evaded. Contentious utterances of one kind or another are not or any great help in a case like this. If such testing was to cease or to be discouraged all of us would suffer and that would be very bad.
The Minister made some points which are very worthy of being underlined. He said that in Ireland a detailed assessment is carried out by the National Drug Advisory Board which then advises the Minister for Health in relation to the issue of a product authorisation or licence to market the medicine in this country. I would like to see the National Drugs Advisory Board brought out a little more from the shade and being asked to issue regular reports more often, particularly in areas like this, for the benefit of the community.
Health is a matter primarily for each individual. The framework of the health services and all the internal mechanisms, drugs and services that exist are facilities but the ultimate responsibility rests on each and every one of us. The Health Education Bureau, in this case the National Drugs Advisory Board and the other agencies involved, should do everything possible to issue clear, simple and regular statements to advance the knowledge that is available in this area. It is perfectly reasonable that we should benefit to the maximum extent from international advances in relation to drug testing and that wherever possible there should be no need to re-invent the wheel. If work has been done I assume the National Advisory Board will take it on board. I wonder if the Minister will confirm what the position is about taking up research already done in such areas.
The Bill is drafted, as the Minister said, in a manner which provides wide scope for control. One aspect struck me as being open to some query, that is the right of the Minister to be able to stop a trial once it has begun. That might have the effect of discouraging investment in proper facilities. I wonder whether or not that is necessary. If all the parameters the Minister requires are in place and if the safeguards are there I wonder in what circumstances it would be necessary for the Minister to intervene, over and above the authority who got the agreement in the first place, and insist on the trial being ceased.
The Minister said that the prior approval of the Minister for Health must be obtained by a person wishing to volunteer for a clinical trial. That is proper. I do not know what the precise mechanism is for that and I wonder if the Minister can spell it out. Does it mean that every time a specific trial is to be undertaken a specific certificate will have to be issued? Will there be some kind of monthly certificate or what happens if there are sub-testings involved; I hope that will not result in a paper mountain where people who should be involved in helpful research in the drugs area will spend half their time filling up forms and inspectors from different Departments will be involved in the vetting of such certificates.
The Minister spoke about a number of factors which are germane to the Bill. He said that the proposed ethics committee should be so constituted as to afford assurance that the justification for the trial will be carefully and impartially considered. He said that the doctors or dentists who will be conducting the proposed trial should be suitably qualified and competent to do so, that the method of recruitment and selection of participants should be satisfactory and that the level of rewards to be made to participants should not be such as to constitute an excessive inducement. Could the Minister harden up a little on that? He is saying today that the details to be included in applications are these, broadly speaking. I wonder if that should be written into the Bill so that it is not an optional matter and so that on every application the Minister or his Department officals do not have to check whether the level of awards is not excessive or that the proposed ethics committee is so constituted and so on. Why not write those into the Bill so that they are standard norms which apply in relation to the constitution of, say, an ethics committee? A couple of hours of discussion would probably come up with the obvious conclusions that they should be independent of the company and should embody a wide range of expertise, perhaps involving the Minister's nominee. Why have such flexibility in what most people will see as commonsense requirements which the companies would probably welcome? Some have their own ethics committees already in place. Why have to go through the bureaucratic examination of each application in these respects?
Would the Minister clarify what he means by saying that while formal approval would be a matter for him he will rely on the expert advice of the National Drugs Advisory Board? Does that mean he will automatically accept such advice, or that it will be a guide to him? There is a difference. If it is the latter, obviously the Minister has a role; if the former, I wonder whether there will be more duplication. I mention the point about the Minister having the power under section 7 to revoke permission granted. Under what circumstances would the Minister see that arising? Assuming all the foregoing, then one is doing business with a reputable agency and with clear guidelines embarking on a trial. I am slightly worried lest that disincentive would discourage people from becoming involved in drug testing at all.
I was pleased the Minister referred to the need to ensure that the risks to the participant do not outweigh the objectives of the trial; some bizarre scientific and medical research has been carried out, which is sometimes very hard to justify to anybody with a rational mind. That process of weighing the advantages of the trial with the risks involved needs to be regularly reviewed as do the guidelines to be drawn up for the information of the applicants. These should be in clear and simple language. Such guidelines exist at present. I know that consent is necessary for volunteers and that consent forms are shown to people, but there is more than a suggestion that some of these guidelines are, perhaps understandably, written in medical terminology. The problem is that a volunteer in the context of the profile mentioned earlier quite often is not disposed to read such consent forms and in many cases may not understand them. The Minister should interest himself in ensuring that such consent forms are clear, intelligible and genuinely open to being understood by volunteers, as indeed should all information which should be given to them. It should be as comprehensive and as clearly written as possible.
The Minister has referred to the question of payments to participants. This has always been contentious. I do not see anything wrong with the suggestion that people should not lose out financially if they take three weeks off work because they wish to volunteer. That is comparable with the not totally appropriate analogy in the context of jury duty, where this is seen to be a service and we are not expected to lose out in terms of being paid our salaries or wages while serving. It is not unreasonable that a fee should be paid. However, it should not be such that money is the primary aim. Everything is relative, but according to the scale of fees payable at the present time it is a big bonus to an unemployed father of five children in the middle of the city of Dublin. It is not a bonus if one is in gainful employment. That is the problem. Whether one can have a scale of fees to redress the problem I am not sure. That up to now has been part of the tragic profile of the volunteers who have undergone these trials, the advantages of which have been of great benefit to us all.
In summary, I wish the Bill well. It is timely. Up to now the subject matter covered by this Bill has been operated in the context of the declaration of Helsinki. It has operated, by and large, successfully. In a sense in a totally unregulated area as far as the State has been concerned, there has been, so far as one can judge, an extraordinary degree of scientific advance with relatively little apparent medical or social drawbacks, not meaning to underestimate the tragedy of some time back. The time, however, has come to put in place the kind of parameters about which the Minister is talking. They will be of advantage. While there is an advantage to the drug companies, perhaps to the volunteers, perhaps to those who run the drug companies, I stress once again that the advantage primarily is to the community ultimately, to each and every one of us. It is time we paid a little more attention to the moral obligation which each of us has in that respect. It is time we changed the perception of drug trial testing from being something that a small number of people have to do if they have no other way of making a living to being something which each and every one of us has an obligation to assist in so far as possible and to make possible a set of social and employment conditions which will facilitate our participation in that role.