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Dáil Éireann debate -
Thursday, 9 Nov 2000

Vol. 525 No. 4

Report on Clinical Vaccine Trials: Statements.

I call for a quorum, as this is a very important matter.

Notice taken that 20 Members were not present; House counted and 20 Members being present,

I will outline the contents of the report of the chief medical officer of the Department of Health and Children, following his inquiries into three clinical trials involving residents of children's homes. The three clinical trials – all involving vaccines – happened in the 1960s and 1970s. Some of the children who took part in the trials lived in children's homes around the country.

At issue, now, are questions of ethical propriety, of consent and of responsibility. These children were in the care of the State and it is important to establish if the State fulfilled its obligations to them.

The report I present to the House today, and which I have placed in the Dáil library, does not – indeed, could not provide the answers to all the questions raised. It cannot be the end of our investigation of this issue and, a little later, I will propose what I believe is the best method of establishing the full truth, the context and the implications of these trials.

I will provide some background information on three trials. Trial No. 1, published in 1962, looked at what would happen if four vaccines – diphtheria, whooping cough, tetanus and polio – were combined in one. At the time, the standard approach was to administer tetanus vaccine – DPT – and polio vaccine separately, at different times and at different injection sites.

Trial No. 2, published in 1971, was to find out if German measles vaccine, administered intran asally, could spread to susceptible contacts. Clearly, if it did, serious consequences could ensue, particularly for pregnant women.

Trial No. 3 was carried out during 1973 but not published. What it compared was the propensity of a commercially available DPT vaccine to produce adverse reactions, as against the capacity of a modified vaccine to produce the same reactions. The modified vaccine had fewer organisms per dose.

Concern about this matter first surfaced almost a decade ago, raised by former residents of children's homes where the vaccination trials appear to have been conducted. The then Minister for Health first answered questions in the Dáil on this matter in 1991. In 1993, there was correspondence between the then Minister and a former resident in a Dublin children's home. In 1997, my predecessor, Deputy Cowen, promised the House that he would have inquiries made into the matter, following which he would consider what was the most appropriate action to take. The Minister commissioned Dr. James Kiely, chief medical officer of the Department, to make the promised inquiries.

From the moment I became Minister for Health and Children, I have been aware of this issue. I have met a representative of past residents of a number of children's homes who believe they might have been involved in these trials.

Even though there does not seem to have been any negative medical outcome from any of these children, the story has made many of them extremely anxious. I have arranged with the chief executive officers of the relevant health boards – the Eastern Regional Health Authority and the Southern Health Board – that, where supporting documentary evidence is available, former residents can be immediately informed whether they were part of any of these three trials. For former residents of the homes in the Dublin area the Eastern Regional Health Authority customer service number is 1800 520 520 and for former residents of Bessboro in Cork the relevant Southern Health Board number is 021 4861360.

In addition, I have ensured a counselling service for any former resident of a children's home involved in such trials. It is available on demand from the relevant health boards and I would encourage anybody in this position to lift the phone and ask for the service. That is by way of background to today's publication of the chief medical officer's report.

Before submitting his report to me, Dr. Kiely sent draft copies to anybody named in it who might be affected by its publication. That afforded them the opportunity to comment on the contents. All those comments were fully considered.

Late yesterday evening we received further correspondence from solicitors on behalf of one of the persons named in the report, and some further issues were raised. As it was too late to include in the report, I am placing that correspon dence, in the appendices attached to the report, in the Oireachtas Library.

On the face of it, the trials appear to have had no medically negative consequences for any of the children involved. In some cases, the vaccine used was somewhat weaker than the alternative but when this emerged, booster doses were given to many of the children involved. We have no evidence that any child contracted a serious illness as a result of the trials.

In view of the fact that the report makes no suggestion that any child was directly harmed by these trials and that two of them were published in prestigious medical publications, it might be expected that, as Minister for Health and Children, I should now be saying that is the end of the story. I want to make it clear definitely, however, that is not what I am saying.

The chief medical officer's report is a good one but it is incomplete. It raises as many questions as it answers and some of those questions go to the heart of our attitudes to children and their rights. The report is incomplete because in some areas the most rigorous interrogation of the system failed to produce documentary records of the trials. In some cases the consultant who conducted the trials believed they took place in particular homes, but the homes do not have files that substantiate this.

While we must remember that the trials were not recent, this lack of documentation is, at best, puzzling. It is certainly unsatisfactory. It is my hope that publication of this report, with the action I will propose to the House, will perhaps help us to fill in the missing bits of the jigsaw by stimulating memories or helping to locate lost files.

I have read and re-read this report and I have discussed it with the chief medical officer in detail. In spite of the informational gaps and the indications that no child was medically harmed, each reading made me more sure that his work must be regarded as the beginning, not the end, of the matter. When a child comes into the care of the State, the State must fight fiercely for all that child's rights, including bodily integrity. The State does not have the right to view children in care as lesser citizens. Their bodily integrity is a basic human right which can never be watered down or infringed.

Clearly, when we look at vaccination trials, the issue of informed consent is immediately involved. I am not satisfied that the chief medical officer has been able to find solid, informed consent, on the record, given by the people who were entitled to give it. Let me put this in context. The history of drug trials includes some ghastly case studies where the rights of individuals were grievously ignored. There have been cases in other countries where prisoners and members of the armed forces were involved in the trials of substances without their knowledge or informed consent. There have even been cases – again, in other countries – where prisoners suffering a lethal illness were used as a "control group". In other words, they were not given a medicine which the authorities knew would save their lives. Instead, they were left untreated to suffer and die in the interests of providing a point of comparison.

The vaccine trials covered in this report are in a different league, a different country and a different time. In addressing them, we must be careful of the reputations of the highly regarded professionals involved. We must remember that in many cases we are looking at marginal degrees of difference in the vaccines administered, not at experimental, unproven or dangerous medications. We must take into account that the protocols of 30 years ago are not necessarily the protocols applied today.

The key issue of consent, however, cannot be fudged because it is fundamental. Children in care have the same rights as other children and the vindication of those rights is the constant responsibility of the State. We need to find out if we cared for the children the way we, as a nation, should have cared for them. If we did not we need to find out the reason for the failure to do so and to apply what we learn to the future. That is our responsibility, as legislators, to the general good.

As Minister for Health and Children, my responsibility goes further. It goes to the individual children involved and it means I must ask questions that this report cannot answer, as follows. If one group of children was given the more experimental vaccine, why was it the children in care who got that one? What rationale led to the decision that children not in the State's care got the regular vaccine and children in the State's care got the variant? Was the end result from each trial for the public good or for the commercial advantage of a manufacturer? Why were some medications given to children who were outside the age group at which those medications were known to be effective? Above all, we must ask why the records of some of the trials are so woefully inadequate at almost every point?

All those questions must be asked, irrespective of the overall intent of the trials and the indications that no child suffered medically as a result. Not only must they be asked, but they must be asked in a context which offers the competence to do investigative and therapeutic trawls. For that reason, I propose to send this report to the Commission on Child Abuse headed by Ms Justice Laffoy, so that she may consider it as part of her wide-ranging investigation. It is a decision based on the rights of the survivors who are entitled to a thorough, wide-ranging and public investigation of the ethical issues involved.

The Laffoy commission offers a comprehensive vehicle for dealing expeditiously and rigorously with the totality of the issues. Its terms of reference are broad and, clearly, this issue comes within its remit. It has the full gamut of powers and personnel needed, an experienced secretariat, a strong panel of experts with the requisite qualifications and an investigative and legal infrastructure, all up and running. That combination offers an unrivalled capacity for ruthless thoroughness and appropriate speed. Much of what the Laffoy commission has been investigating runs parallel to this, so the search methods for documents going back to the 1950s is in place.

There is a clear synergy between investigating this matter and the other matters being addressed by Ms Justice Laffoy. The full gamut of powers at the commission's disposal means that we don't have to reinvent the wheel. Not only does the instrument for comprehensive investigation exist, but it also has compellability and the capacity to provide confidentiality to witnesses. For all these reasons, I suggest to the House that the Laffoy commission is best placed to consider these trials and offers a substantial public forum, not just for those survivors who already believe they were involved, but to many others who, partly as a result of publication of this report, may identify themselves in the coming weeks.

While on this point I want to nail some mischievous rumours put about in the past couple of days that if this report goes to Laffoy it would somehow let the Department of Health and Children off the hook. The suggestion is that Laffoy could not investigate the Department, but that, quite simply, is nonsense. Anybody and everybody can be investigated by the Laffoy Commission. This route is the ultimate guarantor against a cover-up or whitewash of any kind. I want the survivors to be sure of that.

Ms Justice Laffoy has indicated her willingness and competence to take this on and I am grateful to her. My Department will, of course, co-operate fully with her commission because we believe that entering this process makes the following clear and unambiguous statement to survivors: "We don't know whether your rights were protected all those years ago, we just don't know the full facts, but we believe it is important, for you and for the wider society, to move heaven and earth to find out; we want to do it in a forum which has the power to investigate, to compel witnesses, to publish its findings, without fear or favour, and to ensure compensation is made if this is required".

I am aware that members of the Oireachtas wish the report to go before the Joint Oireachtas Committee on Health and Children. As both the Taoiseach and I have said, the report will be referred to that committee for discussion by way of a motion in this House next week. Further investigation is an imperative and the Laffoy Commission is the entity best placed to undertake that investigation.

A desperately simple question arises from this report. Reading it, one finds oneself wondering aloud, who was minding the rights of the children? We do not know the full answer to that, but we can answer the second question as to who is minding the rights of the survivors? Through the information and counselling services arranged with the health boards, through the publication of this report and through its proper referral to the Laffoy commission, it is clear that we are determined to vindicate the rights of the adults who, as children, participated in these trials.

As the Minister stated, this report deals with three sets of vaccine trials carried out in the 1960s and 1970s. Trial one refers to 58 infants resident in five children's homes in Ireland. This compared polio vaccination, given separately to the three-in-one – diphtheria, tetanus and pertussis or whooping cough – with a quadruple vaccine where all four were given together.

Trial two involved 69 children in children's homes in Dublin and 23 children living at home who were given the same vaccine, Rubella, which related, I understand, to potential mental handicap.

Trial three refers to 53 children in mother and baby and children's homes in Dublin, five homes in all, and 65 children at home who were given different sets of vaccines. The children in institutions were administered a modified three in one vaccine. The children who lived with their parents got the usual vaccine available at the time from the Eastern Health Board, as it was then known. Trial three was carried out at the instigation of the Eastern Health Board in 1973 because of an increase in adverse reactions to three in one vaccines in use at the time in the board's area. No objections were raised by the National Drugs Advisory Board, an agency of the then Department of Health, to these trials going ahead.

The Department of Health and Children has questions to answer on this latter point. Both it and the Minister are too eager to refer this report to the Laffoy commission where it will be lost among even more serious allegations and may not be reached for some years. This matter should be examined and reported on separately to shed light wherever it needs to be shed. The Department of Health and Children should not be allowed to decide where a report which may involve issues in which it is complicit should be sent.

The role of the Department of Health and Children needs examination. An expert group was established by the then Minister for Health in 1977 to examine persons who, it was claimed, had been permanently damaged by whooping cough vaccination in the 1960s and 1970s. The group found that, in 16 of the 93 cases presented to it, there was a reasonable probability that the vaccine was responsible. An ex gratia payment was offered to each of the 16, a paltry £16,000, and 15 took the payment. In 1992 the Supreme Court found in favour of the 16th, Kenneth Best. The vaccine was administered to at least 243 children in 1968 and 1969 according to research I have seen. Those dates are relevant to the report we are debating.

The reason I raise this matter is that there must be a reasonable suspicion that there may have been some connection between the bad batch of whooping cough vaccination and the reaction to it by so many children throughout the country and the trial tests subsequently carried out on children, especially those in institutions, to which the report we debate refers. If that is the case, then the Department of Health and Children and/or its agencies share culpability.

By sending the report to the Laffoy commission, the role of the Department of Health and Children will be lost among a welter of detail. It is to Dáil Éireann that the Minister for Health and Children and his Department and its agencies must account. For that reason alone the report should be examined in detail by the Oireachtas Committee on Health and Children with powers to send for persons, papers and records and to compel the attendance of witnesses. The committee was led to believe that the report would be sent to it.

That the Department of Health and Children, an actor in this saga, should itself decide where the report goes raises serious questions. This is a smoke bomb, a three card trick. The Minister for Health and Children is buying cover for himself and his Department at the expense of the reputations of people who certainly are not in the category of child molesters or physical or sexual child abusers.

I have no doubt that many of the people mentioned in the report have questions to answer. In all this we must be centrally concerned about the former residents of the institutions, the children to whom the report refers. However, I contend that their rights, needs and best interests are also being abused by the Minister referring the report to the Laffoy commission which is dealing with abuse per se.

The commission has been charged with the responsibility

. to establish as complete a picture as possible of the causes, nature and extent of physical and sexual abuse of children in institutions and other places in the period from 1940, or such earlier date as the commission considers appropriate, to the present, including the antecedents, circumstances, factors and context of such abuse, the perspective of the victims and the motives and perspectives of the persons responsible for committing abuse.

The commission also has the role

. to afford victims of abuse in childhood an opportunity to tell of the abuse they suffered to a sympathetic and experienced forum.

These children were very young. They were not in a position to tell what happened to them. They are being lumped in with these people who rightly have the opportunity to put their case and be heard. However, the people at the bottom of the queue will be those on whom these trial tests were carried out. They have been duped by the Minister into believing this is the way to go. This is not the way to proceed because it is not in their interests. It is in the interests of the Minister and his Department and that is why he has been so energetic in persuading people that this is the case.

Whereas it is absolutely outrageous that any children in institutions were used as guinea pigs and whereas it is important that they be provided with any counselling and support as is necessary and with whatever compensation is appropriate and fair, it is hardly serving their interests to group them with children who have suffered sexual and/or physical abuse. It is also hardly fair to the people in whose care they were that this implication should be raised. This is so especially because of the content of the report we are debating.

The report states that, "theoretically", vaccines did not leave children open to adverse effects and that there is no evidence that any occurred. The word "theoretically" is interesting. Where the report strongly implies criticism is in the importation of vaccines. The report states that it could not find legal authority either under the Therapeutic Substances Act, 1932, or UCD's licence No. 216 to carry on such trials outside UCD. It also points out that this was well understood, although perhaps not well enough by all concerned.

The report points strongly to breaches of the Nuremberg Code, 1947, and the Declaration of Helsinki, 1964, by the 18th World Medical Assembly on consent. It was very clear that the medical ethic of the day, which should have been known to researchers, stressed strongly the need for consent. There is no evidence that consent was given, although a researcher claims it was.

These latter issues are themselves serious but we must ask, in fairness to all concerned, if this equates to physical or sexual abuse. At its most extreme is it not medical arrogance in full flight? Looking back on the 1960s and 1970s, such professional arrogance was not unusual. This is not to excuse what happened. The children used as guinea pigs are entitled to a full explanation and whatever support and compensation is appropriate. However, all the players must be called to account for the roles they played. The Minister for Health and Children is doing a disservice to these children by simply fobbing off the report on the Laffoy commission and, thereby, letting his Department and its agencies off the hook, perhaps at the expense of the reputations of people who may have been unwise but well intentioned and who certainly were not abusers. To try to correct an injustice done to one group by doing an injustice to others is to perpetuate injustice.

If the Minister insists on voting this through and sending the matter to the Laffoy commission, then he should at the very least agree with me that the Oireachtas committee should be empowered to examine the other matters, namely, the role of the Department of Health at that time and the role of the Department of Health and Children at this time in trying to smokescreen its way out of its responsibilities.

I wish to refer to points the Minister made. He referred to the Eastern Regional Health Authority and Southern Health Board being asked to make themselves available. The report also refers to the midlands where tests were carried out. Why is the Midland Health Board not involved in this matter?

He also said:

In view of the fact that the report makes no suggestion that any child was directly harmed by these trials, and in view of the fact that two of them were published in prestigious medical publications, it might be expected that, as Minister for Health and Children, I should now be saying that is the end of the story.

No one suggests he should say that. His Department has a role in this story which needs to be explained and it will not be explained at a child abuse commission. The Minister also said that questions remain to be answered. There are questions which need to be answered which the Minister did not include in his speech. For example, what was the role of the Department of Health and Children and its agencies? There were no health boards until the early 1970s. Why should the Department decide who can investigate this matter? That is like an accused or an accomplice deciding who will be the judge and jury examining his or her case.

The Minister said Ms Justice Laffoy will look at this as part of her wide-ranging investigation. This should not be part of a wide-ranging investigation – it should be a specific investigation. It has been sent to the Laffoy tribunal so that it will be lost among these wide-ranging issues.

If Members of the House think this matter should go to the Laffoy tribunal, let that be the decision of the Oireachtas committee and the House, and not the decision of the Department which itself has questions to answer.

The Minister stated in his speech, "The suggestion is that Laffoy could not investigate the Department itself". That is not the suggestion. The suggestion is that if we ask the Minister and his officials to appear before the Oireachtas Committee on Health and Children to answer questions next week when the matter is referred to it for discussion, they will use the excuse and smoke screen of saying the matter is with the Laffoy tribunal and they cannot answer questions before a committee of the Houses at the same time. That is my concern. If we want to send it to the Laffoy tribunal after our investigation, that will be fine. However, questions must be answered in the Dáil because the Department of Health and Children is answerable to Dáil Éireann.

The Minister pointed out in his speech that, "Further investigation is an imperative and the Laffoy tribunal is the entity best placed to undertake that investigation". Ministers and their civil servants are accountable to this House. This is Parliament. They are accountable now. The Oireachtas committee should investigate these matters.

The Minister asked, "Who was minding the rights of the children?". That is the point I have been making. The Department of Health and its agencies certainly were not. That is the kernel of this matter. The people who were partly culpable are the people who now want to decide who should investigate this report.

It is not acceptable to me for this matter to be referred next week to the Oireachtas committee for discussion without debate. The leader of my party and I gave notice on the Order of Business that we would require a motion to be put before the House which was debatable and capable of being amended I am giving notice now that we will not agree to take this reference next Tuesday without debate. I am asking the Minister, in all that is appropriate and decent in terms of parliamentary procedure, not to refer this report to the Laffoy tribunal until Dáil Éireann has had the opportunity to make its opinion known in a vote in the House next Tuesday.

The first question that needs to be answered in relation to this report is why the Minister and his Department have deliberately delayed publishing it. The report was commissioned by the previous Minister for Health and Children, Deputy Cowen, in mid 1997. In early 1999 it was reported in the media that the report was finished and under scrutiny by the Attorney General. In effect, the Government has sat on this report for almost two years.

The Attorney General has questions to answer and the public is entitled to hear his answers. Have his time and effort been invested elsewhere, instead of concentrating on this report? The Attorney General, instead of concentrating on the needs of those who were children in institutions, has been concentrating on constructing a vehicle designed to provide a political future for himself. He is concerned, it is widely reported, about delivering a united Ireland, but under his watch it has taken until now to deliver this report. Why?

The Minister for Health and Children in May 2000 stated in reply to a parliamentary question that the report would be back with him within weeks for it to be published. Yet, it is only now appearing after six months. Why? This extraordinary delay raises serious questions about the priorities of the Attorney General, the capability of the Government to deal with issues effectively and the lack of accountability of the Department of Health and Children. It casts a shadow on the assertions made in the Minister's speech about how he is dealing with the issues relating to survivors. His record is one of delay rather than action.

This report is unsatisfactory in many ways. It raises as many questions as it answers. I support the referral of the report to the independent commission, already established to investigate the maltreatment and abuse of children in institutions. I have listened to the adults who were children in the orphanages and homes where these trials were carried out. I find it unacceptable that they were not interviewed as part of the preparation of the report. They are clear about the recourse they want, which is to refer this matter to the Laffoy tribunal. I am surprised at the approach being adopted by Fine Gael, which is opposing the views of those directly affected. It is not respectful of them to call these people dupes.

It is not acceptable to patronise people who have suffered over the years from powerful people telling them what was good for them, an opinion which was often wrong. Those people are telling us what they want and I support their demands and needs. We should take that on board. The Laffoy tribunal has fortuitously been established by statute and is capable of taking on the task.

It is important that fairness prevails in the work of the tribunal and that the danger of hindsight distorting the truth surrounding these clinical trials be averted. All sides must be heard and all possible evidence needs to be garnered. However, the report does not inspire confidence that all the evidence is even available. There are references throughout to a lack of records. This has a major impact on the conclusions. We do not have sufficient information and, more importantly, those directly affected do not have information about their experiences.

This lack of information is part of a bigger picture which affects adopted people in a way that is quite disturbing. At present, adopted people do not have an automatic right to their own medical records. They can only apply to the adoption board for such information. It is up to the board to determine whether they can gain access to such information. It is insupportable that people should be denied such information under any circumstances. I urge the Minister to progress promises made by the Government to introduce the adoption information Bill at the earliest possible opportunity to deal with an injustice that does not belong to the past, like these clinical trials, but is currently still militating against the civil rights of the approximately 40,000 people who were adopted since the passing of the Adoption Act, 1952.

Key questions have not been answered in this report. The first is why did a British pharmaceutical company choose to embark on clinical trials on children in Ireland? It is not clear why such work was not carried out in Britain, although one can surmise that the absence of legislation meant there was no proper regulatory framework here, other than the very limited Therapeutic Substances Act, 1932. The report rightly points out the paucity of statutory requirements, while acknowledging a general adherence to very generalised and limited international codes.

The second question to be answered is why orphanages and mother and baby homes were selected. The vulnerability of children in these institutions should have provided them with protection from, rather than involvement in, clinical trials of this sort. It is well known that people living in institutions can experience greater ill health because of the greater risk of infection. It is on record that the trials were unfair in their application and that children who lived in their own homes were given safer injections – in the sense they were known to be safe at the time – than those given to children in the institutions.

The question of greater infection was particularly true in institutions caring for babies and children. Yet, only one request that we know of to carry out a clinical vaccine trial in a mother and baby home was turned down by a Minister of Health, on the basis that the selection of this group was open to objection. We do not know why it was open to objection. That decision was made as early as 1962 according to the report. Why was it made then and why did a similar ground for objection not pertain in the later trials? The report is silent on these points. Another issue is why did statutory authorities such as the Eastern Health Board and the Adoption Board, which would have to supply information on follow-up checks of the children, agree to work, in effect, with a British pharmaceutical company? Did those bodies not consider such trials were open to objection?

Another issue is that of consent. There are clearly conflicting versions between the medical officers of these institutions and Professor Hillery in relation to consent. The conflict is not resolved in the report and the commission must address the record, in so far as it is possible to do so, on how research of this type was carried out in institutions. It is difficult to see how such research could have taken place without consent being given by someone in authority. That raises the question of the authority of medical officers to make a decision in loco parentis where procedures other than necessary medical treatment were involved.

It is important that these and the other issues are dealt with comprehensively without further undue delay. We may never have all the facts. Looking back from today's perspective, the absence of vital documentation and records is totally unacceptable, particularly when one considers these were research projects which, of their nature, depend on the meticulous recording of information. We should note that the legislation controlling clinical trials was only introduced in 1987 and after the death of a young man who participated in a drug trial. Controls are now in place but they were not when these trials were carried out.

We should also note that infectious diseases are a real and current danger to the health and lives of children. This year alone two babies died from contracting measles. They would not have died if our vaccination programme was fully effective. In parts of Dublin the measles vaccine take-up is on a par with some Third World countries. It is vital that vaccination programmes are developed and delivered to protect children. Clinical trials and research will continue to be part of these programmes but we must ensure that maintenance of the public good does not override the protection of vulnerable children. That is unacceptable now and it should have been unacceptable in the past.

One aspect is worth noting. In the second trial to assess the value of an inter-nasally administered rubella vaccine, the vaccine was effective but it was abandoned because it was difficult for the people administering it but it suited the babies and children better. However, because those administering the vaccine found it easier to inject, that was the resultant form. This raises issues for the Department of Health and Children in regard to current vaccination practice.

There are six vaccines being administered.

The Deputy has concluded her ten minutes.

I know but the Chair was very generous to Deputy Mitchell.

I understand it was agreed on the Order of Business that Deputy Mitchell would—

As usual I read the detail.

I am sorry, a Leas-Cheann Comhairle, it was for Opposition spokespeople.

It is the Deputy's colleagues on the Opposition benches who will run out of time.

Is the Chair saying that, as Opposition spokesperson, I cannot finish my speech? I have very little left to say.

By order of the House the Deputy has ten minutes, and I am notifying her that she has exceeded her ten minutes.

I will not go much over time. Many injections that are currently being given are uncomfortable and painful for babies and distressing for parents. Alternative methods of administering vaccines, whether more demanding on doctors, should be developed in the interests of babies and children who are at the receiving end.

This report will be discussed at the Oireachtas Joint Committee on Health and Children and I welcome that. However, the most important measure and the one demanded by those most affected is to refer this to the Laffoy Commission to continue the work done but so clearly not completed by this report. The Minister for Health and Children needs to give an undertaking that there will be no question of putting this report at the bottom of the line as the commission is working out its priorities. I have sought a guarantee on this and those who were the unknowing participants in these trials and those who initiated them are entitled to the same guarantee.

I would willingly have given the Deputy some of my time because I am indebted to her for her contribution. I was enraged when I read the language used in this report and, unfortunately, the comments made by Deputy Mitchell did nothing to decrease that rage. To use terms such as the Minister was abusing people, duping them or fobbing them off by referring this to the commission is wrong and tries to turn this issue into a political football. The people to whom Deputy McManus referred have stated what they want to happen. They deserve that much respect.

The Minister stated that the State does not have the right to view children in care as lesser citizens. It is obvious from the language used in the letters on file in this report and from what has emerged from reports on children in the care of the State that not only did they view these children differently, they treated them differently. They were treated abominably. The documentary shown last Sunday is just another indication of the way children in care were treated.

The two previous speakers referred to the participants as guinea pigs. There is no doubt that is precisely what they were used as: "the participants in the investigation [1960-61] will be infants aged between three and 12 months resident in children's homes in Éire". If that is not picking out a particular group of guinea pigs with no voice and no one to speak for them, I do not know what is. Professor Irene Hillery, when discussing how it was decided to use these children, because ostensibly it would be difficult to follow them up in normal circumstances, said:

The study was conducted entirely in accordance with acceptable medical ethical standards at the time. I obtained consent for the study from the medical officers in charge. I also obtained consent [this is really galling] from those mothers who requested information but not all were interested—

There is a long-standing precedent in this House that charges are not made against persons outside the House who are not here to defend themselves. I ask the Deputy to keep to that.

I will.

—as they were extremely concerned to protect their anonymity.

I know, as I am sure other Members do, that was not a fact. These mothers did not have a voice and I am sure when this is pursued to its final outcome we will see that mothers were not asked because their consent and view on these issues was not considered to be important.

There is a letter on file relating to the response of the children. It states: "We are indebted to the medical officers in charge of the children's homes.for permission to carry out this investigation on infants under their care and to their nursing staff for their unlimited patience and co-operation." There is no mention of babies or mothers. These were simply guinea pigs and thanks were given to the homes, medical officers and nurses whose only job was to supply hot water. The content of the correspondence between those trying out the vaccines, the medical officers concerned and those in charge in the homes is unbelievable. I presume Ms Justice Laffoy will pursue this in her own way but the co-operation that will be required in order to see this issue through will not be forthcoming from homes where these vaccinations were carried out. I am convinced of that. The report speaks volumes.

The case of a person, who is not in my constituency, was brought to my attention long before I knew anything about these trials. The person, who contacted me because of my involvement in the area of adoption and fostering, has repeatedly complained about the way he has been treated by somebody whose name is mentioned in the report. The authors of the report mention that they spoke to staff members in Bessboro and 78 infants were identified as having received vaccinations in that period. The report states: "No doctor's signature, batch number, manufacturer—

The Deputy's five minutes are concluded.

There is so much more I would like to say on this issue. The Minister said this is the beginning, not the end, and I agree. I have asked repeatedly that records be collated. There are no records where the report is unsure. There are records where it is known that these tests did not take place. Until records are collated centrally people will not get the protection they require.

I wish to share my time with Deputy Gormley.

Is that agreed? Agreed.

Nobody wishes to make a political football of this issue. It is too serious. It involves trials being conducted on almost 200 children, children who were treated as if they were "children of a lesser god". We must find out the why, where and when. That is what this debate should be about.

Deputy McManus wondered about the stance of the Fine Gael Party. One cannot conduct an opinion poll of the 200 children and find out exactly what each requires. There is a case to be made for the analysis put forward by Deputy McManus but there are people on the other side of the argument who want this matter investi gated by an inquiry or an Oireachtas committee rather than the Laffoy commission.

The Minister will be aware of the comments made recently by a local authority member, a former resident of one of the homes involved. That councillor called on the Minister to ensure that the investigation would not be carried out by the Laffoy commission but by the Oireachtas committee. He is reported in the Irish Examiner as having said that the referral of this issue to the commission “runs the serious and very real risk of inducing further anxiety and emotional stress” for the victims in the drug testing issue by associating them with sexual abuse. That is the background.

Deputy Gay Mitchell pointed out that the committee on health and children, using all its powers, can ask the relevant questions now. If it is referred to the Laffoy commission the least the Minister can do is assure the House – I am sure Deputy McManus will agree with me – that it will be dealt with quickly and not go to the bottom of the pile. The commission has a great deal of work to do and we need early and thorough answers on this issue. If it goes to the Laffoy commission, there should be another and fuller debate on this important matter next week in the House.

This is a sensitive and complex issue. I appreciate the difficulties that confront the Minister and I thank him for his courtesy and co-operation in the past few days.

We need to listen to the victims. I am aware that Victor Boyhan made a statement a few weeks ago but I understand he now agrees with referring the report to the Laffoy commission. We can only listen to those people. What matters is that we secure accountability, transparency and truth. It has been said in the past few days that the medical establishment was guilty of, perhaps, arrogance but that what it did was not illegal. I do not accept that. It is not a question of whether it was legal or illegal but whether it was right, justified and ethical. Anybody who grew up in the 1960s would have seen the Christian Brothers hammering the living daylights out of people with their leathers. Was that legal or illegal? Strictly speaking, it was legal until the late John Boland outlawed corporal punishment.

We need to look closely at the motives and whether the so-called advancement of medical science coincided with monetary gain. The link between the pharmaceutical companies and the medical establishment is a little too cosy for comfort. They brook no criticism, as I know from personal experience. I now have the Irish Medicines Board on my back. Legislators have a responsibility to examine not just what happened in the past but what is happening now in relation to vaccinations. I will give the House one—

As it is now 4.45 p.m. I ask the Deputy to move the adjournment. The Deputy will be in possession when the debate resumes.

Debate adjourned.
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