Before seeking the approval of the Seanad for this important resolution, I would like to give some background information concerning the events which have led to the making of this order. I have no doubt this House will agree that one of the success stories in relation to human health in the last century has been the reduction and, in some cases, elimination of disease and death due to infectious diseases, particularly in relation to diphtheria, pertussis and polio. Many of us may recall stories told by parents or grandparents of whole families being wiped out as a result of diphtheria. Thankfully, those days are no longer with us. Vaccines against a range of serious diseases, such as diphtheria, pertussis, polio and measles, have been developed and introduced into vaccination programmes around the world, and Ireland has been no exception in this regard.
The background to this draft order is that as a result of media interest in 1990 and 1991, three vaccine trials that had been undertaken on children in care in Ireland in the 1960s and 1970s were brought to the attention of the then Minister for Health. Two of these trials were the subject of published articles in peer reviewed medical journals. The then Minister for Health answered a question on the matter in the Dáil in May 1991. Interest in these trials continued and on 9 July 1997 the then Minister promised to have inquiries made into the matter following which he would consider appropriate action. The chief medical officer of the Department of Health and Children was asked to make these inquiries on the Minister's behalf and his report entitled report on three clinical trials involving babies and children in institutional settings 1960-61, 1970 and 1973 was laid before both Houses in November 2000.
The Minister has welcomed the interest which Members of both Houses have shown in the report and he shares the view that answers must be provided to the various issues raised in the report. He is also acutely aware of the serious concerns of former residents of a number of children's homes who are concerned that they may have been involved in these trials. These children were in the care of the State and it is important to establish if the State fulfilled its obligations to them.
It is important to state that, in this case, we are looking at marginal degrees of difference in the vaccines administered not at experimental, unproven or dangerous medications. Furthermore, we must take into account that the protocols of 30 years ago are not necessarily the protocols applied today. However, the Minister has already indicated that he is not satisfied that the chief medical officer has been able to establish that solid informed consent was given by the people entitled to give it. He rightly considers this issue of consent to be absolutely fundamental.
The Minister has raised questions which he considers must be asked, irrespective of the overall intent of the trials and irrespective of the indications that no child suffered medically as a result. These are questions which unfortunately the report cannot answer; questions such as, why children in care were given a more experimental vaccine than children not in the State's care. 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? And above all, why are the records of some of the trials so woefully inadequate at almost every point? These questions must be asked in a context which offers the competence to thoroughly investigate the matter. For that reason, the report has been sent to Justice Laffoy so that the Commission to Inquire into Child Abuse may consider it as part of its wide ranging investigation.
This decision is based on the rights of those involved who are entitled to a thorough wide ranging and public investigation of all the issues involved. The Laffoy commission offers the best mechanism for dealing expeditiously and rigorously with the totality of the issues. The appropriateness of referring the report to the Laffoy commission was raised in the Dáil last November. At that stage, the Attorney General advised as follows: The definition of "abuse " in the Inquiry to Child Abuse Act, 2000, includes any wilful infliction of physical injury or failure to prevent such injury to a child and any failure to care for a child, or act or omission towards a child which has serious effects on the child's behaviour or welfare".
In so far as clinical trials are alleged to have been conducted without the appropriate consent and in so far as these trials are alleged to include the use of injections and intra-nasal administration of drugs, quite clearly an issue arises as to whether any such trials amounted in law to an assault or an unlawful invasion of the physical integrity of the children involved. Likewise, the consequences of participating in any such trials are matters relating to the welfare of children. All these issues fall within the scope of the commission as expressed in section 1 of the Act.
It was further stated by the Taoiseach and the Minister for Health and Children that the issue of whether the commission required additional powers by means of a Government order to investigate the vaccines report would be considered by the commission. It was also made clear by the Taoiseach that the approval of both Houses would be sought should such an order be deemed necessary.
Having considered the relevant issues in the intervening period, it is the clear view of both the Attorney General and the chairperson of the commission that, as matters stand, the Commission to Inquire into Child Abuse has the competence to investigate the vaccines report. However, the chairperson has suggested to the Minister that it would be helpful, for the sake of clarity, if the terms of reference for the commission's investigation into the report were to be incorporated in a Government order. This course of action has been agreed following consultation between the commission and the Attorney General's office.
The purpose of the draft order is to define the parameters of the commission's inquiry into the vaccine report. The Government may, under section 4 of the Commission on Child Abuse Act, 2000, by order confer on the commission and its committees additional functions or powers connected with their functions and powers. The proposed order provides for additional functions to be conferred on the commission as follows: to inquire, through the investigation committee, into the circumstances, legality, conduct, ethical propriety and effects on the subjects thereof of (i) the three vaccine trials referred to in the report and (ii) any systematic trials of a vaccine or the mode of delivery thereof to test its efficacy or to ascertain its side effects on a person found by the investigation committee to have taken place during the period commencing on 1 January 1940 and ending on 31 December 1987, and to have been conducted in an institution, following an allegation by a person that he or she as a child in the institution was a subject thereof, and to prepare and publish to the general public in such manner and at such time as the commission may determine a report in writing specifying the determinations made by the investigation committee in its report under article 4 of this order.
The Minister has outlined on a number of occasions the advantages of having the report and its implications fully investigated by the Laffoy commission. The commission has the full range of powers and personnel needed – an experienced secretariat, a strong panel of experts with the requisite qualifications and an investigative and legal infrastructure.
There is a clear synergy between investigating this matter and the other matters being addressed by the commission and the Laffoy commission offers a comprehensive vehicle for dealing with the totality of these issues. Ms Justice Laffoy has indicated her willingness and competence to take on this role and, as the Minister indicated, the Department of Health and Children will fully co-operate with the commission in the course of its investigation.
We believe that entering this process makes a clear and unambiguous statement to those involved in the trials that every effort will be made to find out if their rights were protected all those years ago. We wish to do this in a forum that has the power to investigate, to compel witnesses and to publish its findings without fear or favour.
The Laffoy commission, for all the reasons I outlined, offers by far the best opportunity to secure answers to the many questions raised in the report. I ask Members of the House to approve this resolution.