Dáil Éireann - Volume 371 - 26 March, 1987
Control of Clinical Trials Bill, 1986 [ Seanad ]: Second Stage (Resumed).
Question again proposed: “That the Bill be now read a Second Time”.
An Leas-Cheann Comhairle Jim Tunney
An Leas-Cheann Comhairle: The Chair is happy to call Deputy John Stafford to make his initial contribution to the 25th Dáil.
Mr. Stafford Mr. Stafford
Mr. Stafford: As a new Member of this Dáil this is the first opportunity I have had to comment on this important Bill whose provisions are of vital significance to everybody involved in medical research in Ireland. I have read many of the reports relating to this matter with great interest. I fully realise that great problems will be encountered in seeking safeguards for the unwary without creating impossible difficulties for those concerned in the manufacture and distribution of medicines.
The results of the clinical tests we seek to control eventually are reflected in the medicines prescribed for every man, woman and child in Ireland who becomes ill. It is clear, therefore, that such tests need to be undertaken with the greatest care. This Bill is very welcome. I should like to compliment the Minister on having brought it forward so quickly in this Dáil. Indeed one might well wonder what his predecessor was doing since it took so long to bring the Bill before this House.
It should be remembered always that these types of experiments carry inherent potential dangers and may well lead to tragedy. One need only look at the dangers of AIDS and the possibility of creating problems in the carrying out of such tests. So many young people become involved in these tests, putting their names forward, attracted by financial gain. There was the tragedy a couple of years ago when one young man died tragically because the necessary safeguards did not exist. It is absolutely essential that the age of young people be checked before being allowed to take part in such clinical  trials, as should be the case also with anybody with a medical condition. Any potential volunteers should furnish a report from their general practitioner stating whether they are allergic to any of the substances to which they may be subjected in the course of such tests. I have been informed that many of these tests are horrific and that only people subject to extreme financial stress will volunteer for them. Thus they become subject to the dangerous substances and practices involved in some of these tests.
Controls are absolutely essential and the National Drugs Advisory Board must be given the authority to look into these matters. Medicine is progressing and we must not go back to the time when body-snatching took place. People often wondered why high walls were built around cemeteries because the people inside could not get out and the people outside did not want to get in, but the reason for the high walls was because bodies were often snatched, to be used in medical experiments. It is important that medical tests be controlled by the State.
In the US there are many back lane places that carry out illegal tests. Some of the tests that people here may be asked to undergo are a continuation of illegal tests in the US and we do not know what happened before the tests are suggested here. We do not know what damage these tests may have done already. We do not know if the researchers have taken people against their will from skid row to try out some drugs. It is essential to have control and to ensure that we are not caught up in anything like that.
Huge profits are made in this business but if something goes wrong, who has to pay the bill? No doubt in this Bill there are safeguards against accidents but we do not know what will happen if something goes wrong. It would cost a fantastic amount of money to keep just one disabled person for life. It was suggested that we should ban clinical trial tests here but that would cost us a great deal of experimentation. I welcome this Bill because it imposes severe penalties on people who do not disclose all the information  available about the drugs. It is essential that full information on the proposed test is supplied to the person coming forward. It should be made a criminal offence to procure a person to undergo a clinical trials test. People on drugs or who are alcoholics do not mind what happens to them as long as they can get their money. In the past four years, due to inept government, there has been a vast increase in unemployment. Huge numbers of young people are emigrating and many are submitting themselves for clinical trial tests in Europe and in the US. In places like Greece when people are short of money they sell their blood. They do this also in the US. One wonders who is making the profit. Because of the tragic death of one young man, we should make sure that everything that can be done is done in this Bill to protect vulnerable people. I commend the Minister for his great work in bringing this Bill forward so quickly and I thank him on my behalf and on behalf of the people of Dublin and Ireland.
Mr. Roche Mr. Roche
Mr. Roche: I congratulate the Leas Cheann-Comhairle on his election. As a civil servant some years back, I observed that the Leas Cheann-Comhairle filled this position with great dignity and decorum. It was not my intention to speak at this time on this Bill but circumstances demand that I do so.
I compliment the Minister on bringing forward this timely legislation. The matter dealt with in this Bill is serious and should cause concern to all legislators. It is a sad reflection on the times in which we live that young men and women, because of economic circumstances, are forced to sell their bodies and their health for medical research. It is important, given the very severe economic conditions which can force young people to become involved in medical research, that that research is very closely regulated. That is the purpose of the Bill.
Substantial profits are made in this industry. Therefore, it is appropriate that those who participate in this trade should be subject to the most stringent controls and those who volunteer for research  should be very closely monitored and their interests protected. It is a tragedy that young people should have to offer themselves for financial gain in this way.
I join with other speakers in complimenting the Minister on this legislation. As a new Deputy when I look at the benches opposite I cannot but observe that the health of the public seems not to weigh heavily on the members of the Opposition. When electoral gain could be had from making much of the tragedy to which Deputy Stafford referred, there was no shortage of speakers from the Opposition parties on this issue. It is extraordinary that they are not here to deal with this issue now. It may be that because of a reshuffle in the main Opposition party today there is some confusion as to who does what.
I did not intend to speak on this Bill today. Perhaps later I will make a more lengthy speech. I just wish to join with previous speakers in welcoming this legislation and in complimenting the Minister and Minister of State. I hope that in the years ahead if medical research is expanded, the safeguarding of the individuals participating as willing guinea pigs will be pursued before profit. In this legislation, the State has rightly intervened to ensure the protection of the health of individuals who are forced by circumstances to involve themselves in research.
An Leas-Cheann Comhairle Jim Tunney
An Leas-Cheann Comhairle: I compliment and congratulate Deputy Roche and, similarly, I welcome and congratulate Deputy Jacob on his recent success as he embarks on his initial contribution to the 25th Dáil.
Mr. Jacob Mr. Jacob
Mr. Jacob: I offer my personal and sincere congratulations to the Leas-Cheann Comhairle on his election to this important office. I assure the Chair of my support and co-operation at all times. I thank the Leas-Cheann Comhairle for the kindness and courtesy he afforded me in the few moments when I had the pleasure of speaking to him. If as a new Deputy I inadvertently nod in the course  of familiarising myself with the protocol and procedures of this House I would be very pleased to be put in the right direction by the Chair.
I unreservedly welcome the belated introduction of this Bill. One has to reflect on the might-have-beens and on the untold suffering and misery which might well have been averted had statutory control existed. One must commiserate with those who lost dear ones and with those who are condemned to a less than full life due to disfigurement and other types of incapacity as a direct result of drug induced tragedies which in turn can be seen as a direct result of there having been no statutory protection mechanism.
This Bill will install the necessary safeguards and protection for our people against possible exploitation by unscrupulous or inefficient drug companies and their sometimes over-enthusiastic researchers. The priorities of such people can sometimes be wrong in that they might be tempted to dwell too much on the commercial side, that is profit-making, and therefore be loth to commit the resources necessary for the safety of their human guinea pigs. However, here the often used word “balance” comes into play. There are genuine and responsible drug companies which contributed magnificently to our society, not only in the areas of health and medicine but also in employment. It is vital that that balance be seen to obtain here and that we do not over-indulge in red tape measures which might be to the overall detriment of these companies.
In my humble, non-medical, opinion it is essential that prospective applicants for clinical testing be screened as thoroughly as is medically possible and that this aspect of any clinical trial programme should be given a number one priority. We must minimise risks. In this way it could be possible, using every reasonable available screening technique known to medical science, to catch individuals who may unwittingly jeopardise themselves or who might knowingly jeopardise themselves when financial inducement is  proferred. The Government must be very strict and develop whatever measures are necessary to ensure the laws in this area are rigidly adhered to by those who conduct clinical trials. I cannot stress too much the importance of public safety, for which this Bill is primarily intended. This is the key to keeping to an absolute minimum unwanted deleterious results.
This is a fine Bill as it has finally emerged. In the past 24 hours I have read very carefully the Seanad debates on this Bill. As a new Deputy that was an interesting exercise especially when we recall that certain people were making headlines by calling for the abolition of the Seanad because, they said, it was superfluous. If proof was needed that the Seanad was playing a worthwhile role in our administrative structure, it can be found by reading these debates. Great credit is due to those Senators who contributed to that comprehensive debate which resulted in this Bill being improved and fine tuned. I compliment the Minister for introducing this Bill and I have no doubt future generations will thank him also. I believe the Bill as presented is beyond any significant improvement.
An Leas-Cheann Comhairle Jim Tunney
An Leas-Cheann Comhairle: I now call on the Minister of State, Deputy Leyden, and avail of this opportunity to extend to him sincere congratulations on his well earned appointment to such a prestigious and important office.
Minister of State at the Department of Health (Mr. Leyden) Terry Leyden
Minister of State at the Department of Health (Mr. Leyden): I thank you for your best wishes on my appointment. It is a great honour to be chosen by the Taoiseach and appointed by the Government to be an office holder in this Administration and to be appointed to a very important Department which affect the lives of all. I take this opportunity to offer you my sincere congratulations on your appointment as Leas-Cheann Comhairle. I have served under you as Leas-Cheann Comhairle for three terms and you have always acquitted yourself very well because you were fair and impartial in the Chair. I wish you a long and happy tenure of office.
 I wish to express my appreciation to the number of Deputies who contributed to this debate at relatively short notice. Many of them have made their maiden speeches on this important Bill. This is some indication of how important Deputies consider the Control of Clinical Trials Bill. It is also an indication of what the Dáil is all about. Important legislation is being brought through this House and many Deputies on all sides contributed to this debate. I want to assure all Deputies that the Minister, Deputy O'Hanlon, and I will take into consideration all the points they have made. Many good proposals were made and they will be carefully considered between now and Committee Stage and if we feel they can be incorporated, we will include them.
I take this opportunity to thank the Seanad for their very wise contributions to this debate and my predecessor, Deputy Barry Desmond, former Minister for Health, for his wisdom in accepting the many amendments put forward in the Seanad. This is original legislation and the wisdom of the Upper House has been incorporated in the Bill. I want particularly to congratulate my colleague, Senator Sean Fallon, from the neighbouring constituency of Longford-Westmeath, for his enlightened participation in that debate. He was responsible for many of the amendments incorporated in the Bill now before the Dáil.
This Bill is proof positive of the importance of the Seanad as part of the Oireachtas. I reject statements made by minority parties to downgrade the role of Seanad Éireann. As Members of the Oireachtas we should be proud of the Seanad and support all the institutions of the State, including the Oireachtas itself. The Seanad proved its worth by its participation in the debate on this Bill which will be of immense benefit to future generations.
The tenor of the public debate on clinical trials has been to ensure, on the one hand, that more effective and safer drugs are available while, on the other, that research on drugs and medicines takes  adequate account of the safety of participants in clinical trials. I am familiar with the concept of clinical trials. One of the major drug testing institutes in the country is located in my constituency in south Roscommon and I have visited the premises of Elan Corporation and was impressed by their responsible and caring approach in conducting clinical trials. I visited the premises of the Elan Corporation as a Member of the Dáil some time ago after a major expansion had taken place. On the occasion of the official opening Members of the Oireachtas, the public and the press were shown openly the facilities for clinical trials. At that time people were actually participating in clinical trials. It is a very responsible undertaking for the companies involved and also for those people who are making great sacrifices for the greater good of all by participating in these trials.
Drug research is essential for the rejection of ineffective or toxic drugs and the confirmation of the effectiveness and safety of therapeutic drugs. Indeed, there is a regulatory requirement in almost all countries, including Ireland, that such trials be conducted for a drug before an application for a marketing authorisation for such drug would even be considered.
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. A voluntary arrangement for the clearance of submissions for trials through the National Drugs Advisory Board has been in existence for a number of years. However, it is now generally accepted that comprehensive control of these trials should be guaranteed by a statutory scheme.
The purpose of the Control of Clinical Trials Bill is to provide a legal basis for the control of clinical trials involving human participants. The statutory scheme provided for in this Bill will replace the current informal voluntary arrangements. The Bill provides a legal framework for the control of clinical trials  which, on the one hand, will permit drug companies to carry out legitimate and necessary testing of their products while, on the other hand, ensuring that the safety of participants is protected. Any risks to participants would have to be weighed up in the context of the potential benefits to be gained from the trial and the Bill reflects the safety of the participant as being paramount when conducting a clinicial trial.
Broadly a two-tier structure is proposed in the Bill. The Minister for Health and the National Drugs Advisory Board would, in the first instance, on the basis of strict criteria, evaluate an application for a clinical trial and could either grant approval; grant approval with modification or amendments; refuse permission or revoke an approval at any stage; and the second tier, namely, an ethics committee established with the approval of the Minister, to approve the details of the trial and, if they are satisfied with the protocol and that other strict criteria are met, approve the trial and monitor its conduct. I understand that these ethics committees have been established and certainly were established by the Elan Corporation. We are now through this Bill regulating the composition of these ethics committees and are going to make them more effective.
An integral part of the framework proposed — and a key element — is the requirement that a participant has to give freely his informed consent to participate in the trial and there are further safeguards to enable a participant to opt out of a trial at any time without any contractual liability. The Bill also provides that a sponsor of a trial must have adequate insurance cover to compensate a participant for injuries received as a result of a clinical trial.
The Control of Clinical Trials Bill has been through all Stages in the Seanad where several amendments, some of which were of a substantial nature, were accepted and are now included in the Bill. I do not propose to go into any great detail on the provisions of the Bill. The Minister, Deputy O'Hanlon, has already outlined the provisions in his speech.  Nevertheless, it is such an important measure in the context of achieving a balance between the legitimate and necessary functions of the pharmaceutical industry, the good of the community at large in terms of the continuing availability of safe and effective drugs and the protection of participants in clinical trials that a general recap of the Bill and its objective is worthwhile.
A key provision of the Bill is that prior application must be made to the Minister for permission for the conduct of a clinical trial and sets out the particulars which must accompany such application.
Where new substances are concerned, the applicant will probably be a commercial company or a commercial testing institute in most cases. The company will have conducted animal studies and chemical development in order to provide evidence in support of the safety and quality of their drug. The applicant's medical or dental personnel draw up a trial protocol and, after consultation with various professional bodies, approach investigators who are considered appropriate to conduct the proposed study. In consultation with those investigators a final protocol is decided, facilities and staff requirements are established and any necessary financial arrangements for additional staff, accommodation and equipment are proposed. The design and implementation of all these arrangements are the responsibility of the applicant.
In this context, it is worth noting that the Bill provides wide scope for control while, at the same time, ensuring against a rigid approach in relation to interpretation of the provisions. This is vital when the extent, range and nature of clinical trials which must be carried out are considered. It is most important that we avoid introducing a statutory scheme which would impede through its rigidity the pharmaceutical industry in this country in completing the drug clinical profiles required by drug regulatory agencies for evaluation prior to market. At the same time, however, it is vital that a balance is struck designed to safeguard also the health and rights of those participating  in clinical trials. The interest of medical science and society in general should never take precedence over considerations relating to the wellbeing of the participants.
Where established drugs are involved and new uses are being investigated, this is likely to be sponsored by a pharmaceutical company also. This sort of trial may also take place in a commercial institute but, equally, it may be presented as necessary new kinds of treatment for patients under the care of a consultant in a hospital setting. The broad spectrum of types of clinical trials demonstrates clearly the requirement for control and the need for a structured approach to clinical trials.
The various checks and balances proposed in the Bill, right through from: (1) the involvement of the National Drugs and Advisory Board in evaluating the application for the trial; and (2) the establishment of an ethics committee to approve the trial and to monitor its conduct; (3) the giving of information to a participant to ensure that he or she can give full, informed consent to participate; (4) the time limits laid down during which the Minister must give a decision on an application, and (5) the requirement that insurance cover must be taken out by an applicant to cover injuries to participants as a result of a trial provide a balanced framework through which clinical trials may be controlled.
Some Deputies expressed concern about delays in giving approval to the conducting of a clinical trial. The provisions of section 4 of the Bill guard against any undue delays in giving approval and the procedure will be geared towards expediting vetting of applications. In that regard I must point out that there is an element of job creation involved in this and because of that there will be no delay by the Department in processing applications. I should like to compliment the Minister on expediting this legislation. The measure is an important one and I invite all Members, particularly the Opposition, to outline their views on it. I commend the former Minister  for accepting the many amendments that were tabled in the Seanad. I commend the Bill to the House and I hope it is passed very soon.
Mr. M. Ahern Mr. M. Ahern
Mr. M. Ahern: I should like to congratulate Deputy O'Hanlon on his appointment as Minister for Health. In my dealings with him in recent years I have found him eminently qualified for this post. I should like to congratulate Deputy Leyden, too, on his promotion and to wish him well in his new post. I am amazed to see so many benches vacant on the Opposition side bearing in mind all we heard in recent weeks from those Members about the importance of legislation and so on. They have shown a complete lack of interest in a Bill which is of great importance. The members of the Fine Gael Party must be suffering from the effects of some drug that had not been tested prior to the election. I am sure they would like to carry out a clinical trial on the PDs who are also missing from the Chamber. The PDs appealed for support in the election on the basis that they would go into great detail on all legislation brought before the House but they have been absent from this debate. In my view a Second Stage debate gives Members an opportunity to contribute in a general way on legislation.
There has been an outcry against clinical trials and all types of medical experiments in recent years particularly in regard to animals. Following a tragic occurrence some years ago the general public became aware that clinical trials were being carried out on humans and as a result, there was a call for this type of legislation. I consider the Bill to be of great importance because of what is involved in the whole area of drug testing. It is essential that drug testing is carried out because we do not have any other way of ascertaining the effectiveness of those preparations. We are all aware of the many drugs that were advertised as having magic ways of getting rid of headaches, sinusitis and other ailments but which after the expenditure of millions of  pounds on advertising, proved disastrous for human beings and were withdrawn. It is essential that there should be control over the use of all drugs, particularly at the trial stage. Drugs should not be released on to the market until they have been subjected to proper controlled trials and proved to be effective and not harmful to human beings.
Drug research is essential for the rejection of ineffective or toxic drugs and for confirmation of the effectiveness and safety of therapeutic drugs. Most developed countries have statutory regulations controlling clinical trials. These must be conducted before an application for marketing or authorisation is considered. However, in Ireland there is no provision in existing legislation for a statutory scheme to control the conducting of clinical trials. There has been grave public disquiet about the absence of such statutory controls here. A voluntary arrangement for the clearance of submissions for trials through the National Drugs Advisory Board has been in existance for a number of years but it is now generally accepted that comprehensive control of these trials should be guaranteed by a statutory scheme. The Bill seeks to provide a legal basis for the control of clinical trials involving human participants. The statutory scheme provided for in the Bill will replace the current informal voluntary arrangements.
The former Minister for Health in the Seanad listened to the many points made by Fianna Fáil Senators there and accepted many amendments that helped to improve the quality of the Bill. Effectively, the measure is a legal framework for the control of clinical trials. Drug companies will be permitted to carry out legitimate and necessary testing of their products but the safety of participants is ensured and that is important.
I am concerned about two issues in this area. It is important that the age of the participants is subject to control and that guidelines are given by the National Drugs Advisory Board to the ethics committee on any clinical trial that takes place and which includes young participants. Those guidelines should  include instructions that proof of age should be given and verified before young people sign any form of consent. It is important that every effort is made to ensure that under-age people do not participate in these trials. In cases where there is any reason to suspect that a person may be younger than stated an ID card or birth certificate should be requested. It is vital that the previous medical history of participants should be known to those carrying out clinical tests. Obviously there are some cases where personal and family medical histories would play a great part. For example, where drugs which might have an adverse effect if certain medical tendencies exist are to be tested it is essential that a general practitioner's record of the participant's medical history be secured. Such a record would be particularly important in the testing of drugs intended for use in psychiatric cases. I am sure it would be difficult to detect any signs of previous psychiatric illness if a volunteer did not admit to having a problem in this area. Every effort should be made to check the would-be participant's medical record. If no medical records are available the person concerned should not be allowed to participate in that trial.
This Bill sets out all the necessary controls and imposes restraints on those carrying out tests. I hope it will stop the kind of tragedies that occurred in the past. I fully support the Bill.
An Leas-Cheann Comhairle Jim Tunney
An Leas-Cheann Comhairle: I understand that Deputy Allen has been appointed spokesman for Health on behalf of Fine Gael and I avail of this opportunity to congratulate him and wish him every success in that very important assignment.
Mr. Allen Mr. Allen
Mr. Allen: I have not had an opportunity to study the Bill. I intend to speak on it at a later date. It is not my practice to speak on a Bill without studying it first. I hope to make a contribution on Committee Stage and I am looking forward to working with the Minister on health matters.
Dr. O'Hanlon Dr. O'Hanlon
 Dr. O'Hanlon: I take this opportunity to congratulate Deputy Allen on his appointment. As we all know health care is very important for everyone. While we may have different emphasis on how to administer the service there is a lot of agreement and I hope we will have very constructive debates which will enable us to do something worthwhile for those who depend on us.
Dr. D. Fitzpatrick Dr. D. Fitzpatrick
Dr. D. Fitzpatrick: I speak in support of the Bill. It is a Bill which is long overdue and very necessary. We are all aware of the rather tragic affair which occurred some time ago and which pointed to the necessity for these controls.
The Bill was devised to provide control over investigations into the effects of new medications or the perceived new effects of old medications on humans and to protect the public, particularly participants in drug trials, without closing down the testing or developing of new drugs.
The development of new drugs is a multi-billion pound industry in which Ireland shares. Sections 8 and 9 deal with the protection of participants in trials. Heretofore those who participated in these trials did so not so much for the furtherance of science but for pressing economic reasons. It would be very wrong to take advantage of people's economic circumstances to develop new drugs. Drug testing should always be treated with circumspection. People have suffered as a result of carelessness or eagerness to prove a point. I am glad that these sections control very carefully the testing of drugs.
Section 15 deals with offences and prescribes penalties. I am a little wary of paragraphs (a) and (b). The fines are far too low considering the financial gains that are at stake. Recent developments in the medication field — I prefer the use of that word rather than the word “drugs” which nowadays has undesirable connotations — have rescued companies from the brink of financial disaster. It is the prospect of large financial gains which urge, not unnaturally, researchers and their masters to greater heights. I hope  the Minister will look at the penalty section again before the Bill is made law.
Section 8 (j) states:
any payments whether monetary or otherwise to be made to a person for conducting the clinical trial or any part of the trial;
and paragraph (e) states:
the policy of insurance to which section 10 relates.
My understanding is that these trials will be conducted by medically qualified personnel. Every practising doctor must carry insurance to guard against a claim of malpractice. The people carrying out these investigations would leave themselves open to large claims and I am sure the insurance companies would be loath to allow them to continue without a premium loading.
I understand it is the Minister's intention to ensure that people are not offered inducements to act as guinea pigs. However, most people who offer themselves as guinea pigs do so for monetary gain and not for the advancement of science. People will offer to participate and, therefore, we must ensure that the pretesting checks on such people must be conducted to a rigorous standard, involving physical and psychological tests beforehand.
They are my queries in relation to the Bill and I hope that the Minister will clarify them. The Bill is long overdue, it is a credit to the Seanad, to the staff in the Department of Health, to the Minister and the previous Minister who have tried very hard to bring about a Bill that will not spancel medical research and the development of medication and therapies. I urge the House to pass the Bill.
Unfortunately, the Bill will not protect us from quacks peddling cure-alls to people who suffer from conditions for which we do not yet have a cure. Most practising doctors see patients who suffer from very distressing conditions and who spend large amounts of money travelling from quack to quack in the hope that they will be cured.
Mr. Browne Mr. Browne
 Mr. Browne: A Leas-Cheann Comhairle, I wish you four or five years in the Chair, you are deserving of the position and I know you will conduct your work in an impartial and fair manner.
I wish to compliment Minister O'Hanlon and his Minister of State, Deputy Leyden, on introducing the Bill and I wish them success in the years ahead. Drugs seem to have become glamorised over the past number of years, even the box of Anadin is very well publicised. We do not seem to be able to exist without drugs. The major drug companies and many doctors are making massive profits from the drug business and one wonders if any of this money is put into safeguarding the health and wellbeing of our people. The massive amounts of money which drug companies make may, to a certain extent, be immoral and they should have a major role to play in providing funds, for example, in the development of a breakthrough to control AIDS. The Government and the Minister should seriously consider this point.
The subject of clinical trials has caused concern and alarm to the public, particularly in regard to the recent tragic case which highlighted the dangers people face when they participate in such trials. It also highlights the situation which the Minister is now trying to correct because there was no protection for those people. Up to now there was no legislation for a statutory scheme to control clinical trials and there has been much disquiet in that regard. The purpose of the Bill is to provide a legal basis for the control of clinical trials involving human participants. It is a legal framework for the control of such trials and will permit drug companies to carry out legitimate or necessary testing of their products. New products must be marketed but the general public must be protected from them until they are properly tested.
There are major difficulties involved for the drug companies, manufacturers and distributors in relation to medication. They must ensure that there are adequate safeguards and that all safety aspects are taken into consideration. The results of the tests we are seeking to control are  eventually reflected in the medicines prescribed for everyone. Therefore, it is clear that these tests must be carried out properly. The Bill seeks to ensure that in future all research and testing will be carefully monitored so that there will be no further tragedies involving participants in these trials. There must be built-in safeguards for healthy young people who, because of unemployment, may offer themselves for testing. They may go for the easy buck and those running the trials may be glad to take them on at a cheap rate.
Those taking part in such trials must be medically fit if we are to ensure the future wellbeing of the system. If that were insisted on there would not be any more tragedies. I know that the Minister, Deputy O'Hanlon is very concerned about this whole area and that he will insist on the most stringent regulations from now on. I accept that drug companies feel they must have guinea-pigs but, if I had my way, I would ban them completely although I suppose that is not realistic. It is appalling to have a man or woman described as a guinea-pig and taking part in clinical tests.
I want to give serious consideration to the age of consent and previous medical history. Having read about tragic events in this regard parents have commented that mothers and fathers should have a say regarding the age at which young people should be allowed to take part in clinical trials and should be notified by the people conducting those trials that their son or daughter is taking part. That should be insisted upon.
It is to be hoped that the guidelines laid down by the National Drugs Advisory Board for the ethics committee of any clinical trial will include an instruction that proof of age must be shown and checked before the person involved is invited to sign any form of consent. Every effort should be made to ensure that nobody under age is allowed to participate in these trials. If there is any reason to suspect that a person may be younger than stated perhaps some form of ID could be required. We see the problems of under-age drinking or young  persons getting into discos. A fairly hefty young fellow may get in anywhere or obtain any drink because he looks older than he is. It is important to check that the person is not under age and that he has photographic or ID evidence which can be checked out thoroughly.
Strong guidelines should be set down on the previous medical history of would-be participants. Previous medical history should be investigated completely to ensure that the participant is safeguarded against what may happen and the tragedy of something going wrong. Of course, every effort should be made to ensure that nothing wrong happens. The unforeseen could occur but every safeguard should be availed of. In some of these trials personal and family medical history may be more important than in others. Drugs to be tested could have an adverse effect when certain medical tendencies exist and in such case a GP's record of the participant's medical history is essential. It should not be too difficult to acquire because most reputable GPs keep medical files on their patients. These files should be made available for a thorough check. The people running the clinical trials should contact the local GP of the person intending to take part in the trial and have a dialogue with him and his opinion on whether the trial is in the best interests of that person should be sought. Such records are particularly important in the testing of drugs intended for use in the field of psychiatric care, for instance. It would be difficult without the proof of a medical record to detect any signs of a previous psychiatric illness in the volunteer involved, yet the drugs the persons may be testing could have serious consequences on his or her wellbeing. Records are kept in psychiatric hospitals and if the person makes it known that he has had psychiatric difficulty in the past then that could be checked out.
It is essential in some if not all of the examinations that every effort be made to check the would-be participant's past records and guidelines should be laid down by the National Drugs Advisory Board for the ethics committee concerned.  If no previous medical report is available the person concerned should not be allowed to participate in the trial. The Rush case was tragic, and I am glad the Minister is making every effort possible to ensure that we will not witness such tragic cases in the years ahead.
The public in general abhor the drug scene as it is at the moment. There are so many different types of drugs and drug problems of major proportions obtain in the cities in particular. People, particularly parents, are very concerned at the mention of drugs in whatever sphere. We cannot blame the parents for this because too many parents in the past have become aware that their sons and daughters had been taking drugs without their knowledge and they found out and had to face the consequences when it was too late to do much about it. Parents and young people must be educated into awareness of the serious problems of drugs. When the Minister, Deputy O'Hanlon, was on the other side of the House he expressed serious reservations about the drug problem and he made every effort to ensure that the right type of education and the right warnings were available to parents and young people. I am sure he will continue to do that in his period as Minister.
As I said at the start, I am very concerned about human beings being used as guinea-pigs in clinical trials. While that is necessary and Deputies and the general public are entitled to their opinions, since these trials must take place the Minister through this Bill, the ethics committee and major drugs companies involved must make every effort to ensure that every safeguard is used and that the right to life of the human beings concerned is protected at all times. One could speak for a long time on the Bill. I hope it will achieve what it is intended to do. I am sure the Minister will go in detail into the major areas in the Bill at a later stage in this House and we can question him on some of the sections in it.
Dáil Éireann 371 Control of Clinical Trials Bill, 1986 [ Seanad ]: Second Stage (Resumed).