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High Court of Ireland Decisions
You are here: BAILII >> Databases >> High Court of Ireland Decisions >> Hillary v. Minister for Education and Science & Ors  IEHC 121 (11 June 2004)
Cite as:  4 IR 333,  IEHC 121
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[2003 No. 782 J.R.]
Judgment of Mr. Justice Aindrias Ó Caoimh delivered the 11th June, 2004.
By order of this court (O'Sullivan J.), the applicant was given leave on 3rd November, 2003 to apply by way of an application for Judicial Review for
(a) A declaration that Statutory Instrument 280 of 2001, namely the Commission to Inquire into Child Abuse Act, 2000 (Additional Functions) Order, 2001, (hereinafter referred to as "the Additional Functions Order) made by the Government, is ultra vires the provisions of the Commission to Inquire into Child Abuse Act, 2000 and in particular, s. 4(4)(b) thereof;
(b) An order of prohibition against the fourth named respondent, (hereinafter referred to as the Commission), and/or its Investigation Committee, from proceeding with a proposed inquiry pursuant to the said Additional Functions Order, 2001;
(c) Alternatively, an order of prohibition restraining the Commission and/or its Investigation Committee from proceeding with a proposed inquiry pursuant to the said Additional Functions Order, in as much as the said inquiry involves a full oral adversarial public hearing, without first considering and determining that such a course is required and necessitated by the inquiry and is an appropriate and proportionate method of inquiry, having regard to the subject matter of the inquiry and the rights of the parties, including the applicant;
(d) Alternatively, an order of mandamus requiring the Commission to consider, prior to the commencement of a further phase of the inquiry, whether a full oral adversarial public hearing is a necessary, appropriate or proportionate course, having regard to the nature of the subject matter of the inquiry, the nature of the matters to be resolved, and the interest and rights of the parties, including the applicant;
(e) Alternatively, an order pursuant to O.84 r.20(7) staying the proceedings of the Commission to inquire, insomuch as it purports to conduct an inquiry pursuant to the Additional Functions Order, 2001, pending the determination of these proceedings.
The grounds upon which this relief is sought are as follows;
1. The first, second and third named respondent acted unlawfully in making the said order as the additional functions referred to in the said order do not constitute "abuse" as defined by s.1 (1) of the Commission to Inquire into Child Abuse Act, 2000.
2. The conduct of vaccine trials cannot be considered to be connected to the subject matter of the Commission's inquiry and, accordingly, is not within the scope of delegation granted by section 4(4).
3. A decision to adopt the method of a commission of inquiry with powers to compel witnesses (and to have adversarial hearings in public, and to utilise the vehicle of the existing Commission of Inquiry into residential institutions, which carries connotations in the popular mind of serious sexual abuse), for an inquiry into vaccine trials, the results and methodology of which were the subject of contemporaneous publication and in relation to which no serious dispute of fact arises, was and is unreasonable and, therefore, ultra vires the Commission to Inquire into Child Abuse Act, 2000.
4. The fourth named respondent has by letter dated the 7th October, 2003, addressed to the applicant's solicitors Messrs Hayes a clear intention to proceed with its inquiry notwithstanding the fact that the said Additional Functions Order of 2001 is ultra vires the Commission to Inquire into Child Abuse Act, 2000.
An affidavit has been sworn by the applicant who describes herself as a retired Professor of Microbiology. She refers to the fact that the Commission was established by the Commission to Inquire into Child Abuse Act, 2000 (hereinafter referred to as the Act of 2000). She refers to the role conferred on the Commission by s. 4 of the Act of 2000, which included the function, through a committee, to inquire into the abuse of children in institutions during the relevant period, being the period from and including the year 1940 or such early year as the Commission may determine up to and including the year 1999 and such later periods (if any) as the Commission may determine. The applicant refers to the definition of abuse contained in s. 1(1) of the Act of 2000 which provides as follows:-
"(a) the wilful, reckless or negligent infliction of physical injury on, or failure to prevent such injury to, the child,
(b) the use of the child by a person for sexual arousal or sexual gratification of that person or other person,
(c) failure to care for the child which results in serious impairment of the physical or mental health or development of the child or serious adverse effects on his or her behaviour or welfare, or
(d) any other act or omission towards the child which results in serious impairment of the physical or mental health or development of the child or serious adverse effects on his or her behaviour or welfare, and cognate words shall be construed accordingly."
The applicant refers to what she considers to be the public perception that the Commission's inquiries are thought of as an inquiry into serious sex abuse.
The applicant refers to the fact that on 19th June, 2001, the Government exercised power vested in it under s. 4 (4) of the Act of 2000 to confer additional functions on the Commission, by making an order providing for the following additional functions:
"(a) To inquire, through the Investigation Committee, into the circumstances, legality, conduct, ethical propriety and effect on the subjects thereof of:-
1) The three vaccine trials referred to in the report, and
2) 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 the 1st January 1940 and ending on the 31st December 1987, and to have been conducted in an institution, following allegation by a person that he or she as a child in the institution was subject thereof, and
3) 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 report referred to is a report of the Chief Medical Officer of the Department of Health entitled "Report on 3 Clinical Trials involving babies and children in institutional settings 1960-61, 1970 and 1973". The applicant exhibits this report. She states that the question of vaccine trials in institutional settings is a matter of very particular concern to her. She states that prior to her retirement in 1993, she had worked for 33 years in the Department of Medical Microbiology of University College Dublin and was a participant in the tests relating to the method of administration of various vaccines conducted in 1960-61 in a number of institutions in this State. She points out that the results of these tests were published in the British
Medical Journal and that she was one of six co-authors of the article in question. She exhibits this article.
The applicant points out that the Commission established a division of its Investigation Committee to conduct an inquiry into the carrying out of the tests referred to and further clinical inquiries which were carried out in 1970 and 1973. She refers to the history of this inquiry and the fact that litigation was taken by Professor Patrick Meenan, which litigation was ultimately determined by the Supreme Court on 29th July, 2003, and judgment being delivered on 31st July, 2003.
The applicant points out that this case did not directly raise the validity of the establishment of the vaccine trials section by the Additional Functions Order, although certain observations made in the judgments are, she believes, pertinent and raise questions as to the validity of the establishment of the vaccine trials section. She states that from those proceedings and the decision of the Supreme Court she sought and obtained advice on this matter. The applicant refers to the point that had been arrived at in the Commission's investigations and preparations for a hearing. She expresses the belief that she and Professor Meenan were the principal individuals subject of any possible inquiry, while of course, Wellcome, as a corporate body, would also be the subject matter of the inquiry. She expresses the view that with the outcome of the application taken by Professor Meehan she believes that it is now increasingly apparent that she would be the principal individual party, the subject matter of the Commission's inquiry into vaccine trials. She states that this causes her added concern in relation to the proposed method of inquiry. She states that the question of any inquiry into vaccine trials had arisen out of certain media reports which were, she believes, ill informed, one sided and alarmist. She states that any public or official concerns were not, it appears, allayed by the Chief Medical Officer's report. Accordingly, it was determined that a further inquiry was desirable. She states that while she did not and does not believe it was appropriate that this matter should be mixed together with the principal work of the Commission, she, nevertheless, co-operated fully with the Commission and provided it with documents, a statement and expert witness statements.
The applicant refers to the fact that her solicitors have obtained expert reports in relation to the ethical conduct of the trials, which were forwarded to the Investigation Committee of the Commission. In this regard, she refers to a booklet containing four reports, all prepared in 2003.
The applicant points out that the Commission and its Investigation Committee and solicitors which it appointed to represent the "generality of the interests of those involved with the trial" also obtained reports and she refers to a booklet of these reports.
The applicant states that prior to the decision of the Supreme Court, she had become increasingly concerned about the procedures that the Inquiry proposed to follow. She states that she can understand and accepts that the Commission would wish to obtain contemporaneous records, statements from participants and the advice and views of experts, in order to form some view in relation to the subject matter of the inquiry. If there was some serious factual controversy to be resolved, it might be anticipated that there would be some form of hearing, though not necessarily or automatically held in public. She states that, in particular, in relation to the first trial, it seems that there is no serious controversy of critical fact and the only issue is one of opinion and judgment as to the scientific practice, something which does not necessarily call for adversarial hearing or indeed, specifically legal skills.
The applicant expresses her concerns that the process of public hearing in an adversarial setting would cause irreparable damage to her public reputation.
She states that her reputation, such as it is, is essentially a professional one acquired as a result of many years of study and research, very little, if any, of which was discussed in journals or publications outside her specific field. She accepts that her conduct of her work can be the subject of discussion and comment in that field and she is prepared to defend herself and her work in any scientific or professional debate. She states that insomuch as she had any public reputation, which she doubts, it was only as a reflection of that professional reputation.
The applicant states that it is apparent, however, that the public hearing of evidence, which itself is not seriously in dispute, for the purposes of ventilating information, puts her reputation at the hazard of immediate and crude judgment of either guilt or innocence. She believes that this would be particularly dangerous and unfair, when the inquiry is to be conducted under the aegis of an inquiry into serious abuse, physical and sexual.
She states her belief that it is commonplace that evidence given at the Commission in public sessions, is a subject of substantial media comment which occurs and necessarily takes effect some considerable time before any report is published. She states her understanding that this is a necessary feature of such inquiry and although exceptional, is justified by the fact that the subject matter of inquiry is a matter of urgent public concern, where it is thought essential to place in the public domain at the earliest opportunity evidence and information which will allow public judgment to be formed. She states her belief that this was not the position in relation to any controversy in relation to vaccine trials. She believes that it was incumbent upon both the Commission and the Minister and/or Government, to consider the evidence which had been gathered and to reconsider the question of how, in the light of the information received, it was appropriate to proceed.
The applicant points out that at a time when the Supreme Court gave the decision previously referred to and raised questions as to the validity of the establishment of the Vaccine Trials Division, the work of the Commission became the subject of considerable public controversy and the Minister announced an intention to review the work of the Commission, though only, it appears to her, in relation to its principal function i.e. the investigation of abuse in residential institutions, and to introduce amending legislation. It appeared to her that it would be neither appropriate nor constructive to immediately seek to challenge the legality of the establishment of the Vaccine Trials Division and resolve any questions over its legal basis. She states that instead, she instructed her solicitors to raise the matter in correspondence, both with the Commission and with the Minister, although that correspondence did not result in any positive, or indeed, substantive response.
The applicant refers to a letter dated the 1st August, 2003, written by her solicitors to the Minister for Health and Children and to the Chairperson of the Commission to Inquire into Child Abuse requesting them, respectively, to reconsider their respective decisions to embark upon the inquiry in light of the decision of the Supreme Court in Professor Meenan's case. In the letter to the Minister for Health and Children it was stated inter alia:
"It is clear that 'the additional functions' purported to be given to the Commission by Statutory Instrument No. 280 of 2001 are not concerned with its original functions and that this order is ultra vires the principal Act and lacks legal validity."
The letter requested the Government to revoke the order and immediately initiate the process which will lead to its revocation. The letter stated inter alia:
"The continued existence of this Order and all of the activities purported to be authorised by it are not only ultra vires the Act itself and tainted thereby but also amount to a clear and unequivocal breach of our client's constitutional rights."
The letter continued,
"Such a revocation would have the effect of ameliorating, at least to some limited degree, the profound injustice publicly linking Professor Hillary's name with the phenomenon abuse of children, both physical and sexual, which has so horrified the nation over the last number of years."
The letter to the chairperson of the Commission indicated that a request had been made to the Minister for Health and Children and the letter concluded as follows:
"The purpose of this letter is not only to inform you of our communication with the Minister but, also, to request that in accordance with the provisions of s. 4, sub-s. (b) the Commission should enter into immediate consultation with the Minister and the Government for the purpose of initiating the process of revocation. We respectfully submit that the broad facts of the situation combined with the observations of the Supreme Court (referred to above), make it imperative that the Inquiry now underway should be halted pending the revocation sought from the Government."
Two replies both dated 5th August, 2003, were sent by the Commission's vaccine trials inquiry to the applicant's solicitors. The first letter indicated that the implications of the judgment of the Supreme Court delivered on 31st July, 2003, were then being considered and that the public hearings would definitely not proceed on 29th September, 2003, as was mooted on 1st July, 2003. It was stated it hoped to be in a position to write again in early September to bring the solicitors and the applicant up to date. The second letter indicated the view of the chairperson of the Commission that it was for the Government, not for the Commission, to initiate the process of revocation, should it consider it appropriate to do so. It was indicated that the chairperson would engage promptly in any consultative process in which the Government might request the Commission to engage pursuant to s. 4(4). The letter indicated that if by the 1st September, 2003, the issue raised in the letter to the Government had not been resolved and had legal proceedings been initiated, that consideration would be given to the means whereby the inquiry might be stayed, pending the conclusion of the legal proceedings, always provided the legal proceedings were prosecuted expeditiously. The letter also indicated the fact that the Minister for the purposes of the Act of 2000 is the Minister for Education and Science.
The applicant's solicitors wrote a letter on 10th September, 2003, to the Minister for Education and Science. The letter outlined the concerns in relation to the vaccine trials inquiry and the perception arising from the fact that a matter had been referred to the Commission.
The letter also indicated the view that the model of a Tribunal of Inquiry was inappropriate in respect of the vaccine trials. It was stated that it did not appear that there was any serious conflict of primary fact which required to be resolved by 'adversary court like procedures'. It was stated that there was little dispute between the relevant experts, whether obtained by the Commission or proffered on behalf of Professor Hillary, and insomuch as any inferences were to be drawn, they were not particularly inferences of fact such as would be drawn regularly by a court, but rather inferences of and interpretations as matters of medical/scientific history. It was stated that even in this area there was little substantive difference or dispute and it was thought questionable that it was either desirable or appropriate to have those issues adjudicated on by a Commission, whose principal focus and expertise is the issue of child abuse, where there may be serious conflicts of evidence.
Having referred to the judgments of members of the Supreme Court in the appeal taken by Professor Meenan, it was indicated by the solicitors that the underlying validity of the Vaccine Trials Division of the Commission was a matter which had to be addressed in any event. The authors of the letter suggested that the most appropriate, sensitive, efficient, timely and least costly course would be for the Commission to be directed to publish the statements it had obtained from witnesses, and the core documentation which it had gathered. The view expressed was that this would provide immediate information for interested members of the public, permit individual opinions to be formed and expressed, and judgments to be made by any interested parties including the State. The letter indicated the view that to pursue a full adversarial or inquisitorial hearing in public, where the applicant's lifetime reputation was effectively put in issue, would be cruel and unjust and an unfair and indeed unlawful procedure. On this basis, it was indicated that if the Minister intended to permit the Commission to continue to operate under the statutory instrument and proceed to public adversarial hearings, that instructions had been given to commence proceedings to challenge the legality of the statutory instrument and any further investigatory or accusatorial process. The authors of the letter requested an indication of the course intended to be taken as a matter of urgency so that proceedings could be initiated in a timely fashion and to avoid any unnecessary delay.
It was indicated that if the Minister accepted that there was some merit in the course proposed, that they would be happy, on behalf of the applicant, to engage in any constructive discussion with the Minister or any other interested parties as to the future course the Inquiry might take.
This letter was copied to the Secretary General to the Government and to the Minister for Health and Children and to the Attorney General, but does not appear to have been furnished to the Commission itself.
On behalf of the Commission and its vaccine trials inquiry, a letter was written to the applicant's solicitors on 7th October, 2003, enclosing documentation prepared in preparation for the public hearing. The letter continued,
"Whilst the Division is aware that there are present unresolved issues between yourselves and the Government in relation to the remit of the Division it is also mindful of the fact that it has a statutory mandate to fulfil. To this end, therefore, the enclosed report should be inserted into Book E at section 4 as it is envisaged that it will form part of the evidence to be heard in respect of Trial One."
By letter of 22nd October, from the Vaccine Trials Division of the Commission, it was indicated that the Division had instructed the author Robert Kerr, solicitor to the Vaccine Trials Division, to remind the applicant's solicitors that the observations of the Supreme Court were strictly obiter and were in no way related to any justiciable issue before the court. It was stated that it was only as a result of the correspondence from 1st August, 2003, that the issue had become live. It was indicated that the Division had a statutory mandate to perform, which had not been revoked, and thus the Division was of the view that matters now must move forward. Reference was made to the letter of 5th August, written to the applicant's solicitors. The letter indicated inter alia as follows:
"To date and despite your assertions to the contrary it appears that you have not sought to initiate any legal challenge to the validity of the Statutory Instrument. In those circumstances the Division instructs me to inform you that if it does not hear from you in this regard by close of business on 31 October, 2003 it will deem your purported challenge to have been withdrawn. The Division will thereafter take such steps to advance and pursue its statutory mandate as it deems appropriate."
This letter was acknowledged on 30th October, 2003, when it was indicated that proceedings had been prepared and were being pursued and that application would be made to this Court on Monday 3rd November on an ex parte basis.
In her affidavit, the applicant indicates that in the absence of response from the Government and, since it appeared that the Commission would continue its inquiry, she considered she had no alternative but to challenge the validity of the inquiry.
A statement of opposition has been filed on behalf of the first three respondents, in which it is pleaded as follows:
1. The applicant has failed to comply with the provisions of Order 84 Rule 21(1) of the Rules of the Superior Courts in bringing this application. The applicant applied for and obtained leave to bring these proceedings on 3rd November, 2003. The Order which the applicant seeks to challenge in these proceedings was made and came into operation on 19 June, 2001. The applicant did not act promptly in making the application for Judicial Review and in any event did not act within three months from the date on which it is alleged the grounds for the applicant's application first arose (being when the Order was made on 19th June, 2001). Accordingly, the applicant did not comply with the provisions of Order 84 Rule 21(1) in making her application for leave to apply for Judicial Review in these proceedings.
2. Further or in the alternative and without prejudice to the foregoing, the applicant has been guilty of delay and/or laches in bringing these proceedings as a consequence of which she should be disentitled to the relief which she seeks.
WITHOUT PREJUDICE TO THE FOREGOING, THESE
RESPONDENTS PLEAD AS FOLLOWS:
3. The fourth named respondent, the Commission to Inquire into Child
Abuse (the "Commission"), was established pursuant to the Commission to Inquire into Child Abuse Act, 2000 (the 2000 Act. The principal functions of the Commission are specified in Section 4(1) of the 2000 Act.
(a) to provide, for persons who have suffered abuse in childhood in institutions during the relevant period defined in the 2000 Act, an opportunity to recount the abuse, and make submissions, to a
(b) through a committee:
(i) to inquire into the abuse of children in institutions during the relevant period;
(ii) where it is satisfied that such abuse has occurred, to determine the causes, nature, circumstances and extent of such abuse, and
(iii) without prejudice to the generality of any of the foregoing, to determine the extent to which:-
I. the institutions themselves in which such abuse occurred;
II. the systems of management, administration, operation, supervision, inspection and regulation of such institutions; and
III. the manner in which those functions were performed by the persons or bodies in whom they were vested, contributed to the occurrence or incidence of such abuse, and.
(c) to prepare and publish reports pursuant to s. 5 of the 2000 Act.
4. Section 4(4) of the 2000 Act provides that the Government may, if they so think fit, after consultation with the Commission, by order confer on the Commission and the Committees (as defined in the 2000 Act) such additional functions or powers connected with their functions and powers for the time being as they consider appropriate. The Government is also entitled (after consultation with the Commission) to amend or revoke any order under s. 4(4) of the 2000 Act. Section 4(4)(c) of the 2000 Act provides that where an order is proposed to be made under s. 4(4), a draft of the order shall be laid before each House of the Oireachtas, the order shall not be made unless a resolution approving of the draft has been passed by each such House.
5. The Government duly exercised the powers conferred upon them by s. 4(4) of the 2000 Act, after consultation with the Commission, by making the Commission to Inquire into Child Abuse Act, 2000 (Additional Functions) Order, 2001 (S.I. No. 280 of 2001) (the "Order"), a draft of which was laid before each House of the Oireachtas and a resolution approving of the draft was passed by each such House. The Order was made and came into operation on 19th June, 2001.
6. The Order conferred following additional functions on the Commission, namely:
(a) to inquire (though 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 a report complied by the Chief Medical Officer of the Department of Health and Children entitled "Report on Three Clinical Trials involving babies and Children in Institutional Settings 1960/ 1961, 1970 and 1973" (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 1st January, 1940 and ending on 31st 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
(b) 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 by the Investigation Committee in its report under Article 4 of the Order.
7. The Order further conferred certain additional functions on the Investigation Committee which were:
(a) To make determinations in relation to the matters specified in Article 3(a) of the Order;
(b) To prepare a report in writing of the results of the inquiry referred to in Article 3 of the Order specifying in it the determinations made by it pursuant to Article 4(a) of the Order, and
(c) To furnish the report to the Commission.
8. The Order was not made by these respondents (as alleged at paragraph 1 of Section E of the Statement Requirement to Ground the applicant's Application for Judicial Review) but rather, in accordance with s. 4(4) of the 2000 Act, by the Government. Without prejudice to the foregoing, these respondents do not raise as a ground for objecting to the applicant's claim the non-joinder of the Government as a respondent to these proceedings.
9. The Order is not unlawful and is not ultra vires the powers of the
Government whether under s. 4(4) of the 2000 Act or otherwise.
10. It is denied that these respondents or any of them or their respective servants or agents or the Government acted unlawfully in making the Order on the grounds alleged or at all.
11. It is denied that there is any requirement under s. 4(4) of the 2000 Act that the additional functions referred to in the Order and conferred on the Commission pursuant to the Order should constitute "abuse" as defined in s. 1(1) of the 2000 Act.
12. Strictly without prejudice to the foregoing denial, it is denied that the additional functions referred to in the Order do not constitute "abuse" as that term is defined in s. 1(1) of the 2000 Act.
13. It is denied that the conduct of vaccine trials can not be considered to be connected to the subject matter of the Commission's inquiry and within the scope of delegation granted by s. 4(4) of the 2000 Act. These respondents plead that the additional functions and/or powers conferred on the Commission and on the Investigation Committee by the Order are "connected with" the functions and powers conferred on the Commission and on that Committee by the 2000 Act and further plead that the Government was entitled, in its discretion, to form the opinion that it was appropriate to confer these additional functions and powers on the Commission and the Investigation Committee pursuant to s. 4(4) and that the opinion of the Government in that regard is not subject to review by this Honourable Court.
14. It is denied that the Commission carries connotations in the popular mind : of serious sexual abuse as alleged or at all. Without prejudice to the foregoing, if the Commission does carry such connotations in the popular mind as alleged or at all (which is denied), it is denied that the
I Government is or was thereby constrained in exercising its powers under s. 4(4) of the 2000 Act or that same provides any basis for
I impugning the validity of the Order as alleged or at all.
15. It is denied that a decision to adopt the method of a Commission of
Inquiry for an inquiry into vaccine trials was or is unreasonable or ultra vires the powers of the Government under the 2000 Act, whether by reason of the alleged matters referred to in paragraph E.3 of the applicant's Statement of Grounds or otherwise howsoever.
16. Without prejudice to the foregoing, these respondents do not admit that the results and methodology of the said vaccine trials were the subject of, contemporaneous publication or that no serious dispute of fact arises in relation to them.
17. These respondents deny that the Order is ultra vires the powers of the Government under the 2000 Act or otherwise.
18. The applicant is not entitled to the relief claimed or to any relief.
This statement of opposition is dated 29th January, 2004.
The Commission filed a statement of opposition in which the following grounds are pleaded.
1. The applicant has failed to comply with the provisions of Order 84 Rule 21(1) of the Rules of the Superior Courts in bringing this application. The applicant applied for and obtained leave to bring these proceedings on 3rd November, 2003. The applicant was made aware of the respondent's intention to proceed, through a Division of its Investigation Committee ("the Division"), with an inquiry pursuant to the provisions of the Commission to Inquire into Child Abuse Act, 2000 (Additional Functions) Order 2001 ("the Order") or about February 2002.
2. The applicant did not act promptly in making the application for Judicial Review and, in any event, did not act within three months from the date on which it is alleged the grounds for the applicant's application first arose, which this respondent alleges was February 2002. Accordingly the applicant did not comply with the provisions of Order 84 Rule 2(1) in making her application for leave to apply for Judicial Review in these proceedings.
3. Further, and without prejudice to the foregoing, this respondent states as follows:
(a) In April, 2002, the Vaccines Trials Division of this respondent requested the applicant to assist it in ascertaining details regarding the trials the subject matter of the inquiry, in particular the trial of a 4:1 vaccine which took place in 1960/61 ("Trial One"). The applicant, through her solicitors, supplied details as to her recollection of the institutions and personnel involved.
(b) In July, 2002, the applicant was informed that it was the said Division's intention to issue a discovery direction to her. On 16th July, 2002, she requested, through her solicitors, a grant of legal representation from the Division for the purposes of complying with the Discovery Direction. The applicant was grant such legal representation on 22nd July, 2002.
(c) On 10th September, 2002, the applicant complied with the said Discovery Direction and supplied the said Division with an affidavit of Discovery together with various documents referred to in the affidavit. In December, 2002 the applicant was requested by the said Division to swear a supplemental affidavit relating to the issue of discovery. This was duly sworn by the applicant on 7th January, 2003.
(d) In January 2003, the applicant's solicitors indicated that a witness statement from the applicant was being prepared and noted that the said Division had agreed to furnish the applicant with all the discovery documentation six weeks before 18th March, 2003, the anticipated commencement date for the public hearings into Trial One. A statement was fully forwarded to the said Division on 11th April, 2003, the hearing date having been adjourned.
(e) In March, April, May and June 2003 the said Division held public hearings to deal with various procedural matters in anticipation of the commencement date for the public hearings into Trial One. The applicant was represented by solicitor at all of these hearings. On 7th March, 2003, the applicant, through her solicitor, applied for and was granted full legal representation for the purposes of the public hearing.
(f) The applicant was provided with the Books of Document, containing, inter alia, affidavits of discovery and witness statements of those persons whom the Division was of the opinion could offer assistance and upon which the said Division intended to rely in the course of the public hearing. Throughout May, June and July 2003, the applicant was supplied with further documents upon which the said Division intended to rely at the public hearing.
(g) Further, in May 2003, the applicant's solicitors requested the said Division to provide all details regarding those areas of concern which the Division had in relation to the involvement of the applicant in Trial One.
(h) On 3rd June, 2003, the applicant was served with a Direction to Attend, issued by the Chairperson, for the commencement of the public hearing in relation to Trial One.
(i) On 13th June, 2003, the said Division received four medical expert witness reports which the applicant and commissioned for the purposes of giving evidence at the public hearing into Trial One.
4. On 1st August, 2003, the applicant informed this respondent for the first time of the contention now the subject matter of these proceedings. In September 2003, the applicant indicated that proceedings would be issued without further notice. On 22nd October, 2003 the said Division wrote to the applicant solicitors informing them that, in the absence of any action being taken to pursue any purported challenge, it would deem the challenge to be withdrawn. The applicant sought and obtained ex parte leave to seek certain releifs by way of Judicial Review on 3rd November, 2003.
5. In the circumstances the respondent states that the Applicant has been guilty of delay and/or laches in bringing these proceedings as a consequence of which she should be disentitled to the relief which she seeks.
6. Further or in the alternative, the applicant is not entitled to the relief sought against this respondent in relation to the conduct of its proposed hearings, in that the applicant has at all times engaged with the said Division in the course of its investigations and at no stage has the applicant herein requested the said Division, either in the course of correspondence since February 2002 or at any of the public procedural hearings as outlined above, to first consider and determine whether a full oral adversarial public hearing was in fact required and necessitated or whether such proposed hearing was an appropriate and proportionate method of inquiry having regard to the subject matter of the inquiry, the nature of the matters to be resolved and the rights of the parties including the applicant.
7. Further or in the alternative and without prejudice to the this respondent is entitled to determine the manner in which it will conduct its investigations and hearings into the matters the subject of the inquiry and, in the absence of objection or representations to the contrary, to proceed to conduct its inquiry in accordance with that determination.
8. While opposition to the applicant's contentions concerning the vires of the Order referred to in paragraph 1 hereof is primarily a matter for the first to third named respondents (and the Government of Ireland who made the said Order) this respondent adopts the position taken by those respondents in their notice of opposition concerning the validity of the said order.
9. In the circumstances the applicant is not entitled to the relief claimed or to any relief.
No affidavits have been filed to verify any facts in the statements of opposition.
While the impugned Additional Functions Order was made by the Government no issue was raised as to the non joinder of the Government as a party to these proceedings, and counsel for the first three respondents indicated that no point was being raised in this regard.
While various reports have been exhibited by the applicant, which were commissioned subsequent to the making of the impugned order, I consider that the validity of the impugned order can be judged by reference to same.
I consider it appropriate to make some reference to the report of the Chief Medical Officer, insofar as it formed the basis of the decision to make the impugned order. In his introduction, the Chief Medical Officer states as follows:
1. One of the greatest contributions to human health this century has been the reduction, and ill some cases, the elimination of disease and death due to infectious diseases. A number of factors have contributed to this phenomenon, not least being the widespread use of vaccines. Vaccines against a range of serious diseases such as diphtheria, pertussis, polio and measles have been developed and introduced into comprehensive, population based vaccination programmes around the world. Ireland has been no exception and over many decades, vaccines have been incorporated into a national programme on the basis of a schedule I recommended by the Department of Health and Children and delivered by the Health Boards. Such vaccines have been developed in the main, by commercial companies in accordance with the evolving standards governing the conduct of laboratory and clinical research and have been licenced and brought to general use.
2. In May 1991, three vaccine trials that had been undertaken in the 1960s and 1970s were brought to the attention of the Minister for Health. Two of these trials were the subject of published articles in peer review journals and the third was unpublished. These particular trials have become the subject of public discussion over the past number of years because some of the children who took part in these trials were resident in Mother and Baby homes and children's homes around the country and questions have been raised as to the ethical propriety of these trials.
3. These tria1s initially became the subject of media interest in 1991 on . foot of which the then Minister for Health answered questions in the Dáil on 7th May, 1991. There was subsequent interest in these trials by way of
correspondence between a former resident of a children's home in Dublin and the then Minister in 1993 and finally in media reports in July 1997. This was followed by a statement from the. Minister for Health in the Dái1 on 9th July, 1997, in the course of which he promised to make enquiries into the matter following which he would consider what was the most appropriate action to take."
The report concerned three trials which are identified as follows:-
Hillary, IB, Meenan, PN, Goffe, AP, Knight, GT, Kanarek, AD and Pollock, TM:
Antibody response for infants to the poliomyelitis component of a quadruple vaccine. Br. Med J 1962; i: 1098
This trial in which fifty eight infants resident in five children's homes in Ireland took part sought to compare the poliomyelitis antibody response after vaccination with a quadruple vaccine (Diphtheria, Pertussis, Tetanus (DTP) and Polio combined) with the standard vaccine in use at the time which consisted of DTP and Polio administered separately and at different sites.
Trials of intranasally administered rubella vaccine. J Hyg Camb, 1971; 69: 547 – 553
In this trial sixty nine children resident in a children's home in Dublin had blood taken of whom twelve were subsequently administered intranasal rubella vaccine. In the same trial, twenty three children living at home were administered this vaccine. The purpose of the trial was to investigate whether there was a propensity for intranasally administered vaccine to spread to susceptible contacts and to estimate antibody levels and acceptability of the intranasal technique of vaccination.
Diphtheria, Tetanus, Pertussis Trial (DTP) 1973
In this trial in which fifty three children in Mother and Baby homes and children's homes in Dublin and sixty five children living at home in Dublin were administered vaccine to compare the reactogenicity* of the commercially available batches of Trivax vaccine and Trivax AD vaccine, with a vaccine of equivalent efficacy but of lesser potency.
* Reactogenicity: Events that are considered to have occurred in direct relationship to the vaccination. These events may be local or systemic."
The Chief Medical Officer identified the issues for consideration as follows:
"These trials, although they were undertaken over a period of thirteen years, had a number of factors in common. These were:
(i) The vaccines used were all manufactured by the same company, Burroughs Wellcome referred to in the rest of the report as Wellcome.
(ii) The researchers* were members of the staff of either the Wellcome company or the Department of Medical Microbiology, University College Dublin (UCD) and, in the case of Trial 3, the Eastern Health Board.
(iii) Participants in all three trials included babies and children resident is Mother and Baby homes and childrens' residential homes in Ireland.
In considering the trials, a number of issues need to be clarified and addressed. These are:
(1) What were the statutory controls relating to the importation and
use of the vaccines used in the trials and were these complied with?
(2) What were the statutory controls relating to the conduct of clinical trials and were they complied with?
(3) What were the ethical standards which governed such trials, particularly in relation to the principle of consent, and were these complied with?
(4) Were the participants exposed to any, or additional risk, by reason
of the administration of these vaccines.
It is proposed to describe, in so far as it is possible, the relevant context and background within which these trials took place, how the individual trials themselves were conducted, and then to deal with each of the issues identified (1-4) above as they apply to each individual trial."
At pages 40 to 42 of the report, the Chief Medical Officer set forth a summary of his conclusions, followed by a statement in relation to current controls relating to clinical trials. These are as follows:
1. In the case of the three clinical trials involving the use of childhood vaccines that were brought to the attention of the Minister, the vaccines in each trial were manufactured by Wellcome laboratories and subsequently used in these trials. The research institutions involved in the trials were Wellcome laboratories in the UK and, the Department of
Medical Microbiology in University College Dublin and, in Trial 3, the Eastern Health Board.
2. These vaccines were administered to a total of two hundred and eleven children in Ireland, one hundred and twenty three of whom were resident in children's homes in various parts of Ireland.
3. As these were clinical trials, a number of issues have been raised as being important in the assessment of the propriety of these trials.
4. The Therapeutic Substances Act,1932 was the statute governing the
importation and use of vaccines in these trials. It has not been possible to locate or identify documentation which would confirm whether or not
the legal requirements of this Act were complied with in respect of these three trials.
* In respect of Trial 3, the modified vaccines used and the protocol for the trial itself were the subject of a letter of no objection from the National Drugs Advisory Board under a voluntary, non-statutory code of approvals in place at the time.
5. As the subjects of these trials were children, effective consent to their participation in the trials could only have been given by their parents or guardians. The requirement for such consent to be obtained was clearly understood by researchers and articulated in a number of documents
available to the research community at the time.
* As regards Trial 1, there is no documentation available which describes any arrangements arrived at with management or parents for the conduct of this trial. Professor Hillary has asserted that the management, medical officers and mothers were aware of the nature of the trial and gave their consent on that basis.
* As regards Trial 2, there is no information available which can clarify one way or another, whether consent was obtained for the participation in this trial of those children who were resident in the children's home mentioned because there are no records.
* As regards Trial 3, the question of consent is unclear. Available correspondence seems to indicate that the Medical Officer of some of the
homes may not have been aware that residents of these homes were being given the vaccines prepared for the trial in use at the time. Professor Hillary asserts that she sought and received permission to use these newer vaccines in the homes as part of a clinical trial.
6. It was not the practice to follow-up vaccinated children for other than
very short periods and the participants in these trials were not followed up in the longer term.
Current Controls Relating to Clinical Trials
* The current situation in relation to the conduct of clinical trials is now significantly different from that which existed at the times of the trials referred to in this report. In particular, the Control of Clinical Trials Act, 1987 introduced strict regulatory controls on the conduct of clinical trials in Ireland. Under the Act, a person now proposing to conduct a clinical trial must first seek and be granted the permission of the Irish Medicines Board before undertaking the trial. In addition to such permission, the approval of an appropriate ethics committee must also be obtained. The Act also provides a range of protections for persons participating as volunteers in clinical trials, including a requirement of informed consent."
Mr. Donal O'Donnell S.C., on behalf of the applicant, referred to s. 4(4)(a) of the Act of 2000 which provides as follows:-
"(4) (a) The Government may, if they so think fit, after consultation with the Commission, by order confer on the Commission and the Committees such additional functions or powers connected with their functions and powers for the time being as they consider appropriate."
He also referred to the express terms of the Additional Functions Order. It can be seen from a reading of this Order that before the making thereof, the report of the Chief Medical Officer was referred to the Commission by the Minister for Health and Children on 13th November, 2000, and the Commission was requested by him to inquire into the clinical trials referred to in the report. It also can be seen that the Chairperson of the Commission requested the government to define the parameters of the inquiry. This is what the Additional Functions Order purports to do and it refers to the additional functions at Article 3, and further additional functions are conferred on the Investigation Committee by Article 4 of the Order. These articles read as follows:
"3. The following additional functions are hereby conferred on the Commission, namely:
(a) to inquire, through the Investigation Committee, into the circumstances, legality, conduct, ethical propriety and effects on the subjects thereof of –
(i) the 3 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
(b) 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.
4. The following additional functions are hereby conferred on the Investigation Committee namely:
(a) to make determinations in relation to the matters specified in paragraph (a) of Article 3 of this Order,
(b) to prepare a report in writing of the results of the inquiry referred to in the said Article 3 specifying in it the determinations made by it pursuant to paragraph (a) of this Article, and
(c) to furnish the report to the Commission."
Counsel indicates that the respondents do not positively identify, either in the statement of opposition or on affidavit how it is alleged that the matters the subject matter of the Additional Functions Order constitute abuse, or indeed, state, as a matter of fact, that the Government so concluded. Counsel indicates that if, as the Government implicitly contends, the conduct of the vaccine trials comes within the definition of 'abuse' then, since the vaccine trials were carried out in or in relation to institutions, they were, on this logic, already within the Act and no order under s. 4 was necessary, or should have been made.
Counsel submits that the question of whether the vaccine trials are "connected to" the child abuse into which the Commission was established to inquire, and comes within the scope of delegation contemplated by s. 4, is the central issue in this case and raises the question of the manner in which the court should approach the interpretation of both the powers of delegation and the purported exercise of such powers.
Counsel stresses the fact that with regard to the vaccine trial, no suggestion of any injury or harm arising from the trials has been established. It is submitted that quite the reverse is the case. It is submitted that there has been no claim of injury or of any abuse, and that the Commission had to appoint solicitors to represent the interests of children who were the subject of the trials. Counsel contrasts the situation governing the vaccine trials, where there is no mention in the report of the Chief Medical Officer of harm or abuse as defined, with the situation whereby there was considerable urgent public concern with regard to institutional child abuse.
Counsel refers to the various reports that were obtained and submits that there is a high degree of unanimity in the reports and these suggest that the clinical trials were conducted within the then norms.
Counsel refers to the judgments of Keane C.J. in Patrick Meenan v. Commission to Inquire into Child Abuse (Unreported, Supreme Court 31st July, 2003). At p. 20 of his judgment the Chief Justice stated, inter alia, as follows:-
"This is an inquiry into medical procedures in use more than forty years which, it would seem, from the evidence which has so far been made available to the High Court and this Court, were conducted in accordance with the then prevailing standards of which, not to put it anymore strongly, appear to have only the most tenuous connection, if any, with the appalling social evil of the sexual and physical abuse of children in institutions, which was the specific area into which the Commission was established to inquire. The fact that close on half a century has elapsed since these events would inevitably mean that those who could give assistance to the Commission in relation to what transpired might be elderly people in poor health, such as the appellant."
Later, at p. 22 of his judgement, the Chief Justice stated, inter alia, as follows:-
"We were invited during the course of argument to treat this inquiry as in some sense analogous to inquiries at present being conducted by tribunals of which, in one instance, Moriarty J. is the sole member, and in another Judge Alan Mahon is the chairman. Those inquiries are being conducted into serious allegations of political corruption arising out of events in comparatively recent times. They have been mandated by the Oireachtas on foot of resolutions authorising the establishment of inquiries into, in the language of the Tribunals of Inquiry Act, 1921, "definite matters of urgent public importance". The inquiry under consideration could not be further removed in its nature and scope from such inquiries."
At p. 3 of his Judgment, Hardiman J., stated inter alia as follows:-
"In the Act of 2000, the term (child) "abuse" is given a special definition. On this appeal, no question was raised as to whether the subject of the inquiry mandated by the statutory instrument was, or required to be, within that definition. I therefore assume that the additional functions are intra vires the Government and the Commission. But even on that assumption it may be unfortunate for Professor Meenan and other persons in similar circumstances, that the Inquiry into Vaccine Trials is being carried out by a body denominated "The Commission to Inquiry into Child Abuse". The question of the propriety of the 1960 Vaccine Trial is as far removed from the common understanding of the term "child abuse" as can be. That common meaning, unfortunately, is accurately reflected in the headline of a newspaper report of the hearing of this appeal. This inquiry is described as the "Sex Inquiry". This understanding of the remit of the Commission is legally inaccurate but pervasive. This is a factor which would be of a legitimate concern to anyone dealing with the Commission on a matter without any sexual element to it at all. It is also a matter relevant to the possibility of reputational damage arising from association with the Commission."
Counsel refers to the situation involving the Additional Functions Order as one involving confusion and ambiguity from the outset. It is submitted that there was a lack of connection between the subject matter of the vaccine trial and the subject matter of the inquiry and there was a lack of certainty in relation to the matter. In the first place, the Government could not refer the report of the Chief Medical Officer to the Commission unless it considered it came within the existing functions and was, therefore, capable of constituting abuse. However, the Government took a different approach thereafter by invoking the power under s. 4 (4) of the Act of 2000. Counsel refers to the words in s. 4 (4) (a) relating to the conferring on the Commission and the Committees "such additional functions or powers connected with their functions and powers for the time being as they consider appropriate". On this basis, counsel submits that there must be a connection between the subject matter of the Inquiry into the Vaccine Trials and the existing functions and powers of the Commission and Committees. Counsel submits that the ambiguity and confusion that existed at the outset still persists. Counsel identifies the issues arising on this application as firstly, what is the scope of the delegation permitted by s. 4 (4) and secondly, whether the exercise of the delegation in the instant case was valid and involved a consideration of proper procedures or fair procedures.
Counsel submits that the reasonableness of the conclusion reached by the Government in making the Additional Functions Order is something that must be capable of being tested by the court. It is submitted that to establish this reasonableness, evidence must be given. It is submitted that it cannot be said that the decision of the Government was reasonably arrived at, in the absence of any evidence put forward by the Government. Counsel refers to s. 4 (4) and indicates that the subject matter of the inquiry cannot be a separate self-standing inquiry. It is submitted that the power contained in this section cannot be seen as an alternative form of inquiry to a tribunal of inquiry under the terms of the Tribunals of Inquiries Act of 1921.
Counsel submits that what is contemplated by the section is a direct and close or rational connection between the subject matter to be inquired into and the existing functions of the Commission and its Committees. Counsel asks rhetorically 'On what basis could it be concluded that an inquiry into vaccine trials and the ethical propriety of same could be connected with an inquiry into abuse as defined in the Act of 2000?'. Counsel asks 'What fact is common to both inquiries?'. Counsel further asks what exists in the Commission's procedures to make it an appropriate body to carry out the inquiry?' and further questions whether the procedures adopted are appropriate in any event.
Counsel further asks whether the Commission has any skill which makes it a body which is appropriate, in the context of expertise, to consider the ethics of vaccine trials at the time in question. Counsel further asks what piece, or body, of information coming to the Commission makes it appropriate. Counsel further questions what features the two inquires share that make it appropriate that the Vaccine Trials Inquiry be conducted by the Commission. Counsel questions whether any person, the subject matter of the inquiry, is a person "connected with child abuse". Counsel submits that the only essential connection between the two inquiries is that both involve children in the care of the State in State Institutions. Counsel questions whether it was within the contemplation of the Oireachtas that the power would be used in this particular way.
Counsel submits that the Commission of Inquiry into Child Abuse is not a vehicle for self-standing inquiries. Counsel submits that before the vaccine trial could be referred to the Commission, the conclusion would have to be drawn that the subject matter of the inquiry could constitute abuse, or be connected with the functions and powers of the Commission and it Committees.
Counsel refers to the ground at para. 13 of the statement of opposition filed on behalf of State relating to the non-reviewability of the decision of the Government and submits that this is wholly misconceived and is a fatal defect in the respondent's case.
Turning to the manner of the inquiry proposed by the Commission, counsel submits that no indication has been given as to how the Commission proposes to proceed and this is still the situation as of today. Counsel submits that it still appears to be the case that it contemplates a full oral hearing. Counsel submits that nothing should be assumed in favour of the respondents.
Dealing with the Chief Medical Officer's report, counsel submits that the only issue which arises is the third issue identified by the author, namely, what were the ethical standards which governed such trials, particularly in relation to the principle of consent and were these complied with. In this regard counsel refers to portion of the report at pp. 16, 17, 18, 19 and 20 and a portion of 21.
In reference again to the decision in Meenan v. Commission to Inquire into Child Abuse (Unreported, Supreme Court, 31st July 2003) counsel refers to pp. 11 and 12 of the judgment of the Chief Justice, in which he states as follows, having referred to s. 4 of the Act:-
"There is no indication in the report of the Chief Medical Officer of Health, which is recited as having lead to the invocation by the Government of its powers under this provision, of any abuse of children within the meaning of the Act having occurred in the institutions in the context of the trial which is now the subject matter of an inquiry by the Commission. It is not clear how a conclusion could have been reached that the power conferred on the Commission to conduct such an inquiry could be regarded as an additional power or function "connected with their functions and powers" '
The proceedings which were the subject of the appeal to this Court took the form of judicial review proceedings, in which the appellant sought, inter alia, an order of certiorari quashing the decision of the respondent to issue the direction already referred to and an application, by way of special summons, brought by the Commission under s. 14 (3) to the High Court for an order directing the appellant to comply with the direction. The vires of the statutory instrument was, however, not challenged in either of these proceedings in the High Court or this court on behalf of the appellant."
Counsel submits that the question of whether the vaccine trials are "connected with the functions and powers of the Commission" or the child abuse into which the Commission was established to inquire and, thereby, come within the scope of delegation contemplated by s. 4, is the central issue in this case and raises the question of the manner in which the court should approach the interpretation of both powers of delegation and purported exercise of such powers. In this regard, counsel refers to a number of authorities including Laurentiu v. Minister for Justice, Equality and Law Reform  4 IR 26, City View Press v. An Chomhairle Oiliúna  I.R. 381 and Cassidy v. Minister for Industry and Commerce  I.R. 297 with regard to establishing the following principles:-
1. A statute purporting to delegate power must set out the policies and principles by which the exercise of the delegated power may be carried out and judged.
2. If the exercise of the delegation is more than the mere giving effect to principles and polices which are contained in the statute itself, the purported exercise of the power will be invalid and is ultra vires the Act. If, however, the action is only the filling in of details, the principles already having been established, then the exercise of the power will be valid.
3. Even if otherwise intra vires, the exercise of a delegated power must be reasonable.
Counsel submits in that applying these tests it is important to consider the essential features of the Act of 2000. Counsel refers to the investigation of shocking claims of widespread abuse in institutions as having been the basis of the establishment of the Commission. It is submitted that the establishment of an inquiry with a function to hear and determine evidence, find facts, which may be extremely serious and have consequences adverse to the good name of citizens, and for all those purposes to exercise powers to compel attendance of citizens, refusal to comply with which may lead to imprisonment, is still, even in these days, the constitutional exception, rather than the norm.
Counsel submits that the phrase "connected with" appearing in s. 4 must be understood as requiring some clear, direct and intimate connection between the existing inquiry and the subject of the order under s. 4. It is clear that additional powers could only be granted in relation to the specific functions already established by the Act of 2000. It is submitted that the additional functions must be closely related to the original inquiry, perhaps to pursue a line of inquiry not known at the time of the passage of the Act, but which emerged in the course of the inquiry itself. Counsel submits that the Oireachtas could not have intended that the inquiry established by the impugned order was something in its contemplation at the time of the passage of the Act of 2000. Counsel submits that the only possible points of similarity between the two inquiries is that they involve children who were residents in institutions, albeit in different institutions in respect of which there is no overlap. It is submitted that this far too tenuous to be the type of connection contemplated by s. 4. Counsel submits that the inquiry, the subject matter of the impugned order, is so far removed from the core business of the Commission as not to have been in contemplation of the Oireachtas when the delegation under s. 4 was created.
It is further submitted that the additional functions referred to in the Additional Functions Order do not constitute abuse as defined by s. 1 (1) of the Act of 2000 and is consequently ultra vires that Act.
In the alternative, it is submitted that, even if it is considered that a vaccine trial is capable of coming within a very extended definition of abuse, or, alternatively, an equally extended definition of 'connected with', nevertheless any decision to establish such an inquiry could not be reasonable in the sense outlined by Cassidy v. Minister for Industry and Commerce  I.R. 297. Counsel submits that a full blown adversarial hearing held in public is an extraordinarily intrusive form of inquiry, which is capable of doing considerable damage to the reputation of citizens and which is only justified because of some urgent public need. It is further submitted that the fact that such an inquiry would be carried out by a commission, which in the proper public mind was established to inquire in to the most serious and shocking allegations of sexual abuse, would only compound the sense of intrusion and damage that would be felt by a citizen, the subject of such an inquiry. Counsel submits that any decision to establish a full blown adversarial inquiry in to the essentially medico-historical issues of the ethical rules controlling vaccine trials in 1960 or 1961 is, or should be, open to considerable doubt and scrutiny.
Counsel questions the entitlement of the Government to rely entirely on an assertion that its decision is not subject to review by the courts in the absence of evidence pertaining to such conclusion or that the courts should infer that such conclusion was arrived at by the Government. Counsel refers to The State (Lynch) v. Cooney  I.R. 337, Desmond v. Glackin (No. 2)  3 I.R. 67 and Duff v. Minister for Agriculture and Food  2 I.R. 22 to the effect that where a statute permits a Minister to act on the basis of an opinion, the court may be required to investigate whether the opinion in question was bona fide held and whether it was factually sustainable and not unreasonable. Counsel contrasts the situation in the instant case with The State (Lynch) v. Cooney  I.R. 337 where the Supreme Court recorded the fact that the Minister had disclosed to the court his reasons for acting as he did. This he did by swearing an affidavit disclosing the factual evidence and material which he had before him. Counsel refers to the fact that the respondents made no effort to explain why it was considered that the vaccine trials issue was connected with the institutional abuse of children and why it was thought appropriate or desirable that an inquiry into the vaccine trials should be carried out in tandem with the inquiry into institutional abuse. Counsel submits in the absence of any evidence that this court should conclude that the impugned order is, and was, unreasonable and invalid.
As against the Commission, an order of mandamus is sought directing it to consider, prior to the commencement of a further phase of the inquiry, whether a full oral, adversarial, public hearing is a necessary, appropriate, or proportionate course to adopt, having regard to the nature of the subject matter of the inquiry, the nature of the matters to be resolved and the interests and rights of the parties, including the applicant.
Counsel refers to the fact that the Chief Medical Officer in his report urged that the investigation which was recommended should be "reasonable and proportionate". Counsel refers to the report itself in this regard. Counsel further refers to the expert reports which the Investigation Committee has received, being the reports of Dr. Karina Butler, Dr. Richard Ashcroft, and Dr. Richard H. Nicholson. Counsel submits that there does not appear to be any major divergence of expert opinion between the experts retained by the Investigation Committee and the applicant, who has commissioned four reports, which are exhibited by her. These four reports are those of Dr. Christine Miller, Sir David Hull, Professor Gill and Dr. Jim Clinch. On the basis of this convergence, it is submitted that it is wholly unnecessary and unrealistic to hold a full blown adversarial type inquiry, in public, in relation to a matter in respect of which, firstly, there is no real controversy and, secondly, no real criticism of the applicant. Counsel refers to the principle of proportionality as recognised in Irish law, requiring as it does that the rights and interests of a citizen should not be interfered with unless it is sought to achieve a valid social objective which justifies the interference and furthermore, that even when such interference takes place it should go no further than is absolutely necessary to achieve the identified result. Counsel concedes that where there are disputes as to fact, it may be necessary to hold an oral hearing with rights of examination and cross examination to seek to resolve that dispute. It is further recognised that it may be desirable that such a hearing should be held in public. However, it is submitted that it ought not to be assumed that the only form of inquiry is one which involves the public
cross-examination of witnesses. Counsel submits that not only can the issues in the Vaccine Trials Inquiry be resolved in a manner which does not involve potential for damage and injury to the rights of the citizens, but, furthermore, a more refined form of inquiry would be more appropriate to address the mixed issues of medical history and medical ethics involved in an inquiry into the conduct of the vaccine trials more than forty four years ago. Counsel submits that the Commission is obliged, at least, to consider the appropriate form of inquiry and give reasons for its decision.
With regard to the delay on the part of the applicant in moving to this Court for the relief which she seeks, it is submitted that there is no substance or merit in any case in this regard advanced on behalf of the respondent. Essentially, the case made is that the gravamen of the applicant's complaint is not a challenge to a decision made by an administrative body, but rather a challenge to the validity of the Statutory Instrument purported to be made pursuant to the powers granted under s. 4 of the Act of 2000. It is submitted that the invalidity, if established, affects everything the inquiry does. On this basis, it is submitted that the circumstances giving rise to the claim are continuing circumstances which entitle the applicant to bring these proceedings at this time. Without prejudice to the submission, it is submitted that if the court were to consider that the application was not moved within time as required under O.84, r. 21 para. 1, that this is an appropriate case for an extension of such time. Counsel refers to the underlying facts of this case and the judgment of the High Court in Eastern Health Board v. Farrell  1 ILRM 446 in which Geoghegan J., in granting the reliefs sought, noted that the application for judicial review was out of time and had not been made promptly. He held, however, that the issues were far too important to permit the judicial review application to be determined on a time point only unless some serious prejudice had been caused. In that case he held that no such prejudice had been demonstrated. Counsel submits that a similar approach should be adopted by this Court on this application.
On behalf of the first three respondents and, in effect, the Government, it is submitted by Mr. Maurice Collins S.C., that, in the first instance, the Additional Functions Order does not purport to direct the inquiry to be conducted in any particular way. He seeks to defend the Additional Functions Order. In the context of s. 4 subs. 4, he stresses the fact that the impugned order was made by a decision of the Government, having consulted with the Commission, and any proposed order had to be laid before the Houses of the Oireachtas and had to be subject to resolutions of each House of the Oireachtas before the same took effect. Counsel stresses the fact that the Act required a positive resolution of each House of the Oireachtas before the impugned order could take effect. On this basis it is submitted that in reply to the rhetorical question 'By whose will was this order made?', that it was by the combined will of the executive and each House of the Oireachtas.
Counsel refers to the fact that it was the Oireachtas which established the Commission and its Committees and it was the Houses of the Oireachtas that conferred upon the Government, subject to the positive assent of both Houses of the Oireachtas, the power to make an additional functions order.
Counsel submits that s. 4 (4), being an Act of the Oireachtas, contains a presumption of constitutionality. Counsel submits that the instrument of the Additional Functions Order differs from the type of instruments routinely challenged on the basis of vires. Counsel refers to the fact that other orders quashed by the courts in the past have related to delegated laws of the land affecting rights of persons to whom the orders were directed. It is submitted that, in the instant case, the impugned order does not determine rights of liabilities of any parties. It gives the Commission a function of inquiry and reporting to the Oireachtas.
Counsel further submits that the applicant has failed to indicate any authority to show that a statutory instrument should be subjected to reasonable scrutiny, as if it were an administrative decision. Counsel submits that the resolutions passed by each House of the Oireachtas constituted essential elements in the decision to make the impugned Additional Functions Order. Counsel submits that it must be assumed that the powers conferred would be discharged in an appropriate manner. By reason of the involvement of each House of the Oireachtas, it is submitted that the Government cannot encroach on the powers of the Houses of the Oireachtas under Article 15 of the Constitution in making the Additional Functions Order.
Dealing with the nature and effect of the impugned order, counsel refers to the recitals in the statutory instrument itself. This shows the basis upon which the order was made. In this regard, counsel relies upon the order itself and, as in effect incorporated by it, in the report of the Chief Medical Officer. Counsel stresses the fact that the Commission and the Investigation Committee is chaired by a person who is a judge of the High Court. Counsel stresses that this is a further assurance that the procedures to be followed will, in any event, be fair to all concerned. Counsel further refers to the fact that the Commission does not administer justice and does not have the power to impose penalties. On this basis, it is submitted that the decision to set up such an inquiry, or to add to its terms of reference, cannot amount to the administration of justice.
Counsel refers to the authority of The State (Lynch) v. Cooney  I.R. 337 and refers to the fact that what was at issue in that particular case was a decision making power affecting personal rights. It is submitted that that situation can be contrasted with the instant case, where the impugned decision did not determine or affect the personal rights of anyone. Counsel submits that the order merely mandated the Commission to conduct an inquiry and to report on it. Counsel refers to the fact that in deciding to refer the matter to the Commission, the Government were not taking any view that any ethical impropriety occurred. Counsel further refers to the fact that three years have now elapsed since the making of the order.
Counsel submits that if the process of inquiry results in no finding of any wrong doing, then that is the result of the inquiry. This would result in the vindication of those concerned in the vaccine trials. Counsel refers to the fact that the evidence of the Commission tends to suggest that the applicant did nothing wrong and, in this regard, counsel submits that this, however, is not a basis for impugning the Additional Functions Order. Counsel submits that there has been no form of predetermination of any wrong doing on the part of the applicant. Counsel submits, however, that this Court should be blind to the fact that public statutory inquiries are a feature of modern political and public life. It is, in essence, a statutory body with powers of compulsion under the Act of 2000 and it is given a large measure of discretion.
Counsel refers to the fact that the Commission and its members are independent in the performance of their functions under the provisions of s. 3 subs. 3 of the Act of 2000. Counsel submits that the Government, having made the impugned order, did not, and do not, seek to interfere with the manner in which the Commission carries out its functions.
Counsel refers to the provisions of s. 4 of the Act of 2000, including the fact, having regard to subs. 2 thereof, that the inquiry under subs. 1 should have been conducted in such manner and by such means as the Commission considers appropriate. In this regard, counsel refers to the provisions s. 11 of the Act of 2000 and, in particular, subs. 3 thereof, which empowers a committee to conduct meetings otherwise than in public. Counsel indicates that there is no requirement under the Act that the Commission or its Investigation Committee adopt any particular form of procedures and there is in fact no requirement that it proceeds in public.
Counsel refers to the judgment of Hardiman J. in Meenan v. Commission to Inquire into Child Abuse (Unreported, Supreme Court, 31st July, 2003) and submits that any complaint with regard to the procedures followed by the Commission is itself not a good ground for impugning the order of the Government. Counsel submits that it cannot be said that the approach adopted by the Commission is inherent in the impugned order, or a necessary consequence of same.
Counsel submits that the essential issue is whether in making the impugned order the Government acted within the terms of s. 4 subs. 4 of the Act of 2000. Counsel submits that the best guide to what the Government did is to be found by a reading of the provisions of s. 4 of the Act, which, it is submitted, have been complied with.
Counsel submits that the provisions of s. 4 subs. 4 envisage an incremental increase in the powers and functions of the Commission. Counsel stresses the fact that the power is given to the Government "as they (sic) consider appropriate". It is submitted that Oireachtas consciously intended the Government to have significant discretion under the provisions of s. 4 (4) of the Act of 2000.
Counsel refers to the words 'connected with' appearing in para. (a) of the subsection and submits that this cannot be treated as synonymous with something synergistically or intimately related to the subject matter of the inquiry. Counsel stresses that the Government's discretion is subject to review by the Houses of the Oireachtas. Counsel submits that one must presume that the members of the Houses of the Oireachtas properly consider the exercise of the power vested in them under s. 4 of the Act of 2000. Counsel stresses the fact that this power was a power conferred by the Houses of the Oireachtas on themselves.
Counsel refers to the fact that the subject of the trials in question were children who were in institutions, to which the Act of 2000 applied. Counsel submits that the report of the Chief Medical Officer indicated grounds for concern. He referred to the vulnerable cohort of children, who had not had their welfare protected. Counsel refers to the fact that the vaccine trials themselves are the matters into which the Commission has been asked to inquire.
Counsel refers to the judgments of the members of the Supreme Court in Meenan v. Commission to Inquire into Child Abuse (Unreported, Supreme Court, 31st July 2003) and suggests that the court expressed views which were not, strictly speaking, appropriate to the matter coming before it. Counsel refers to the report of Dr. Karina Butler, being one of the expert reports obtained by the Commission. Counsel asked the question 'Was the Government entitled to take the view that the trials were appropriate matters to refer to the Commission?' in the circumstances where the trials were carried out on children in institutions. Counsel refers to the report of the Chief Medical Officer, in circumstances where parents were not exercising the normal protective functions of parents, and to the question as to whether the children in question were subject to appropriate medical procedures. Counsel refers to the judgment of the Supreme Court in The North Western Health Board v. H.W. & C.W.  3 IR 622 pertaining to the right of parents to determine medical intervention for their children. Counsel stresses the importance that children have the protection of their parents. He concedes that the heads of the institutions and other doctors may have given consent to the trials in question. Counsel indicates that the belief may have been present that standard vaccines were being administered at the time. Counsel refers to the Therapeutic Substances Act, 1932. Counsel asks whether the Government was entitled to be concerned with whether the Act in question was complied with. Counsel refers to the fact that non-standard vaccine products, which may or may not have been approved under the Act of 1932, were administered to the children in institutions run on behalf of the State, in circumstances where, at the very least, there may be a doubt as to whether the Act in question was complied with.
Counsel refers to portions of the report of the Chief Medical Officer. At p. 12 of the report, there is a reference to the fact that Dr. Hillary's name is included in some of the records but otherwise there is no doctors' name or signature, batch number or name of manufacturer included in any of the other records. The Chief Medical Officer records
"On the basis of this information, particularly the description of the quadruple vaccine given, it seems reasonable to infer that some or all of the twenty children who completed the course of vacation were part of the trial. However, this is not explicitly stated on any of the records".
At p. 13 of the report, it is stated that the health boards were not in existence at the time when this trial took place and were only established in 1971. The Chief Medical Officer stated that it was not possible to make any comment on what may have happened in four other homes at which the trials were said by Professor Hillary to have taken place, in the absence of any original documentation which would confirm that such trials actually took place. At p. 15 of the report, the Chief Medical Officer indicated that while the file relating to Professor Meenan's research licence is available, a thorough search for the files associated with the operational aspects of the licence going back over forty years has been unsuccessful. The paragraph continues as follows:-
"The files do, however, indicate that the requirement to apply to the Minister for permission to use vaccines outside UCD was well recognised and, on at least two occasions, Professor Meenan sought authorisation under the terms of his licence to undertake research in locations other that University College Dublin. Professor Hillary has indicated that she was unaware of the existence of this licence and, therefore, of the requirement to have ministerial sanction for research outside UCD."
The report noted that no documentation relevant to Trial 1 has been located in the Department, despite an exhaustive search. It is further indicated that in a discussion held with Professor Meenan, he indicated that he had no documentation in his possession in relation to this particular trial, nor had he any personal recollection of the trial and the circumstances surrounding it. Further, the Chief Medical Officer indicated that there is, therefore, no information available which can establish whether or not the statutory requirements regarding the importation and use of these vaccines in this trial were fully complied with.
At p. 19 of his report the Chief Medical Officer records:-
"In a public statement of 9th July, 1997, Professor Hillary says that the researchers received the consent of some of the parents of the infants involved in the trial. In subsequent communications, Professor Hillary has asserted that she requested and received the permission of both the management and medical officer of the home in Bessboro to carry out a trial and she understood that all the parents whose infants were participants were informed either by her or the manager of the nature of the vacation being undertaken and they gave their consent on that basis. There is a statement in the published article that the Medical Officers in the homes gave permission to carry out the trial on infants under their care. This is the only reference to consent in the article. The question of consent is not addressed in the trial protocol."
The Chief Medical Officer further recorded:-
"In the home in Bessboro, Cork, the mothers of the infants would also have been resident there but there is no written evidence to indicate whether the mothers' consent was sought or obtained for their children's participation in this trial. Further, there is no documentation available in Bessboro which describes the arrangements made between management and the researchers for the conduct of this trial."
The Chief Medical Officer further recorded:-
"In principle, it appears to be the case that the authorities in whose care children were placed and who, in the absence of parents or guardians, were in loco parentis, were entitled to give consent for medical treatment (including vaccination) on behalf of the children in circumstances where, in their judgment, that treatment was in the child's interest. It is not clear however, that such authority would extend to giving consent to an intervention which, while it would confer certain benefits on the child by way of protection against a number of infectious diseases, was clearly a clinical trial, the outcome of which or the level of benefit accruing to the child could not be predicted. It is also unclear what standing, if any, medical officers attached to the children's homes had to give consent."
At p. 25 of his report the Chief Medical Officer recorded as follows:-
"The name of the children's home is not mentioned in the published article. The principle author, Professor Hillary, indicated to the Department of Health and Children the name of an institution in Dublin where she thought it may have been carried out. The Eastern Health Board has investigated this but has indicated that there are no records available which would confirm it. The Wellcome Company has indicated that there is no original source material relating to this study in its archives and so it has not been possible to identify the home in which this trial took place."
At p. 29 of his report under the heading 'Standard 2', the Chief Medical Officer records:-
"As regards consent, while the authors mention in the article that
permission was given by the parents of the children from the Midlands involved in the study, no such statement is made in relation to the children's homes. It has not been possible to locate a copy of the original trial protocol so it is not possible to say if there was any reference to consent contained in it."
At p. 35 of his report, the Chief Medical Officer indicates the absence of information available, which can establish whether or not statutory requirements regarding the importation and use of these vaccines in this trial were fully complied with. This pertains to the third trial. At p. 36 of his report, the Chief Medical Officer refers to the absence of reference to consent in the trial protocol made available by the company. Further, at p. 38 of his report, the Chief Medical Officer indicates that the Eastern Health Board has been unable to locate any documentation relating to certain aspects of the trial.
Under his summary the Chief Medical Officer states, inter alia, at p. 40 of his report that the Therapeutic Substances Act, 1932 was the statute governing the importation and use of vaccines in these trials. It has not been possible to locate or identify documentation which would confirm whether or not the legal requirements of this Act were complied with in respect of these three trials. At p. 41 in his summary, he indicates the absence of documentation in regard to the trials and indicates that the question of consent is unclear.
It is submitted by counsel that the report in question raises questions of an important kind, as to whether the institutions had received vaccine products which under the then scheme had not been authorised, and whether appropriate persons had given consent and informed consent and, further, the issue as to whether the vaccine products administered were other than the standard vaccine products. Counsel submits that the report was capable of giving rise to concerns and went to Government. Counsel submits that the Government considered it appropriate to refer the report to the Commission. Counsel submits that it must be presumed that the Government formed the view that it was appropriate to refer the matter to the Commission on the basis of the report. Counsel submits that these additional functions were connected with the existing functions of the Commission. Counsel indicates that the Government was empowered to make the order in the words of the section "if they so think fit". Counsel submits that the additional functions were connected to the existing functions and that there was a common thread more that sufficient to establish the connection insofar as it involved children who were vulnerable children because they were in institutions and, further, because they did not have parental protection. Counsel indicates that they may have had non-standard vaccine products without the consent of their parents.
Counsel suggests that questions or issues arise as to whether the children's welfare was properly protected while in the institution. It is submitted that the Government was entitled to come to a view that the matters were sufficiently connected to make the impugned order. Counsel submits that the alleged administration of non-standard, non-authorised vaccine products, without the consent, or fully informed consent, of those whose task it was to fulfil the role of the parents in these institutions, was a matter the Government was entitled to say was connected with the existing functions of "abuse" as defined in the Act. Counsel submits that these existing functions pertain to how institutions were operated and, further, how they were supervised and is submitted that all these are matters which were part of the functions of the Commission under the Act of 2000.
Counsel further submits that the Commission has the advantage of discharging the task of inquiry into the matters referred to by the Additional Functions Order. Counsel submits that the functions are connected functions and that it was appropriate to make the impugned order. Four matters are referred to as supporting the case that there was a strong connection between the functions and those conferred by the order namely:-
a. The subjects of the vaccine trials at issue were children.
b. Some or all of those children were in "institutions" as that term is defined in s. 1 (1) of the Act of 2000 at the time vaccine trials.
c. The vaccine trials all took place within the "relevant period" within the meaning of the Act of 2000.
d. The vaccine trials, the subject matter of the impugned order, gave rise to genuine concerns for the welfare of the children involved.
In reference to the authorities referred to by counsel for the applicant in this case, counsel submits that Cassidy v.Minister for Industry  I.R. 297 does not give rise to a free standing test of review. Counsel submits that the issue in that case was whether, under the terms of the legislation, what was being conferred was within the contemplation of the Oireachtas and so submits that there was no fresh test of review in that case. Counsel refers to the fact that in the Cassidy case there was no resolution of the Houses of the Oireachtas.
Counsel refers to portion of the judgment in that case, where, at the end of p. 310 of the report Henchy J. stated, inter alia, as follows:-
"The general rule of law is that where Parliament has by statute delegated a power of subordinate legislation, the power must be exercised within the limitations of that power as they are expressed or necessarily implied in the statutory delegation. Otherwise, it would be held to have been invalidly exercised for being ultra vires. And it is a necessary implication in such a statutory delegation that the power to issue subordinate legislation should be exercised reasonably. Diplock L.J. has stated in Mixnam's Properties Limited v. Chertsey Urban District Council  1 Q.B.D. at p. 237 of the report:-
"Thus, the kind of unreasonableness which invalidates a bye-law [or, I would add, any other form of subordinate legislation] is not the antonym of 'reasonableness' in the sense of which that expression is used in the common law, but such manifest arbitrariness, injustice or partiality that a court would say: "Parliament never intended to give authority to make such rules; they are unreasonable and ultra vires."
Counsel submits in the context of this quotation that there is no version of the Government's decision being afflicted by manifest arbitrariness, injustice or partiality.
Counsel refers to a portion of the judgment of O'Higgins C.J. in Burke v. Minister for Labour  I.R. 354 where at 356 he stated inter alia as follows:-
"I wish merely to add that where powers are given by
Parliament to a committee or body, as in this case, it is to be expected that these will be exercised not only in the manner indicated but also justly and fairly. The need for such justness and fairness is all the more apparent where there is no provision for appeal, or for parliamentary supervision and where discretion is given to the designated committee or body as to the manner in which the powers are to be exercised."
Counsel indicates that in the instant case the power in question was in fact the subject of parliamentary scrutiny.
Counsel further refers to portion of the judgment of Henchy J. at p. 361 of the report, in reference to the power of the Labour Court to amend the employment regulation order in question, as follows:-
"Where parliament has delegated functions of that nature, it is to be necessarily inferred as part of the legislative intention that the body which makes the order will exercise its functions, not only with constitutional propriety and due regard to natural justice, but also within the framework of the terms and objects of the relevant Act and with basic fairness, reasonableness and good faith. The absoluteness of the delegation is susceptible of unjust and tyrannous abuse unless its operation is thus confined; so it is entirely proper to ascribe to the Oireachtas (being the Parliament of a State which is constitutionally bound to protect, by its laws, its citizens from unjust attack) an intention that the delegated functions must be exercised within those limitations."
Counsel submits that it must be presumed that a government set about exercising powers under s. 4 (4) with an appropriate eye on what s. 4 states and with an understanding of its requirements and that as a result of a process it will act with constitutional propriety.
Counsel further refers to the judgment of Finlay C.J. in Goodman International v. Mr. Justice Hamilton  2 I.R. 542, and to the portion of the judgment at p. 586 of the report, where he stated that he was satisfied that the presumption of constitutional validity, which had been applied by the Supreme Court in a number of cases to statutes enacted by the Oireachtas and to Bills passed by both Houses of the Oireachtas and referred to the court by the President pursuant to Article 26, applies with equal force to the resolutions of both Houses of the Oireachtas, as were in issue in those proceedings.
In the same case, McCarthy J. stated inter alia at p. 610:
"The parliamentary resolution requires due respect from the judicial
organ of government; whilst the range of the remit contained in the resolutions has been alleged to trench upon the judicial power, there has been no suggestion of any impropriety or abuse of the parliamentary power. If an allegation of impropriety or abuse of power were to be made, then, both as to ascertaining the facts and enforcing constitutional rights, to echo the words of Ó Dálaigh C.J. in The State (Quinn) v. Ryan  I.R. 70 at p. 122:-
'The courts' powers in this regard are as ample as the defence of the
In reference to the decision of the Supreme Court in Meenan and to the judgments referred to by counsel for the applicant, counsel for the State and the Government submits that the issue of the vires of the order was not at issue in those proceedings and, further, the State respondents in these proceedings were not party to those proceedings. Counsel submits that the observations of the Chief Justice in that case were obiter and submits, by reference to the passage of the Chief Justice referring to public perception, that the powers of Government under s. 4 (4) must be judged by reference to what the Act says and not by reference to public perception.
Counsel seeks to clarify para. 13 of the statement of opposition, to the effect that the order in question is not one which it is contended is not reviewable, but that the court should conclude that it is connected with the functions of the Commission under the Act of 2000. Counsel submits that once there is a connection, the Government was entitled to refer the matter to the Commission. Counsel submits that once the connection is established, this gives to the Government a jurisdiction to make the order but that the order, then made is not subject to review.
Counsel submits that the validity of the Additional Functions Order falls to be judged by reference to the Order itself, the report of the Chief Medical Officer and the provisions of the Act of 2000. Counsel submits that the court is concerned, in essence, with the one question only, namely, whether what was done by the Government is permitted by the Act of 2000. Counsel submits that the issue addressed in Cassidy v. Minister for Industry  I.R. 297 was, in essence, a variety of the same question of vires. Counsel submits that the reasonableness test applied in that case was no more than a slight modification of the test of vires, namely, by reference to what was permitted by the statutes. Counsel submits that one cannot go behind the order and that the court is not concerned with what was in the mind of the law makers. Counsel submits that the court must make a legal judgment whether the order in question was ultra vires or otherwise. It is conceded that if the order was not inter vires, the court must quash same. Counsel stresses that the order in question speaks for itself.
In reference to the issue of delay, counsel relies on the provisions of O. 84, r. 21 of the Rules of the Superior Courts. Counsel submits that it is not sufficient for the applicant to say that the matter is one of public importance. Counsel relies upon the fact that the Commission was allowed to proceed.
Counsel refers to the judgments of Denham J. and Fennelly J. in DeRóiste v. Minister for Defence  1 IR 190 and Dekra Éireann Teoranta v. Minister for the Environment and Local Government  2 ILRM 210 and submits, by reference to these judgments, that in permitting a period of almost two and half years to elapse between the making of the impugned order and the commencement of these proceedings, the applicant has plainly failed to comply with the provisions of O. 84 r. 21 (1) of the Rules of the Superior Courts. She has not acted promptly as required, nor did she bring her application within three months or six months as required.
Having failed to bring the application promptly, or within the relevant period, it is submitted that the applicant must persuade this Court that there is "good reason" for extending the time for the making of her application. Counsel submits that on the basis of the authorities and on the facts disclosed in the applicant's affidavit, she has failed to establish "good reason" as to why the court should grant any extension of time to her to bring these proceedings. It is submitted that public policy required that the proceedings challenging the order should be brought promptly and on the facts they were not. On this basis it is submitted that the application herein should be refused. Counsel submits that aside from the Commission itself there is a large number of parties not party to the proceedings, with a direct and personal interest in the proceedings, not least those who participate as children in the trials in question. Counsel submits that it is reasonable to assume that those parties would wish to see the proceedings of the Commission continue and that this court should infer, having regard to the lapse of time since the order was made that they expect that the Commission will continue. It is submitted that these expectations will be frustrated if the applicant obtains the relief which she seeks. It is submitted that this is another reason for dismissing the application in limine.
On behalf of the Commission, it is submitted by Deirdre Murphy S.C., that the submission of counsel for the applicant that there was no contest on the facts of the case is not supported by the evidence. Counsel questions the suggested facts that
1. The first trial was conducted within the norms of the time.
2. That no one was injured.
3. That no one claims to have suffered abuse.
4. That the subject of trials had a mean age of twenty two months.
5. That no child or institution comes within the remit of both the Vaccine Trials Division and the general abuse inquiry.
6. That there were no General Medical Council ethical guidelines in existence at the time.
Counsel submits that these are all matters which the inquiry was set up to
determine. Counsel submits that to categorise these matters as uncontested facts reveals a flaw in the application by misunderstanding and misconstruing the statutory instruments and the impugned order. Counsel refers to the recitals on the face of the order.
Counsel submits that an error which has arisen in the instant case is to treat the report of the Chief Medical Officer as established fact. It is submitted that it is only the starting point for the inquiry. Counsel submits that an injection, if administered unlawfully, amounts to abuse as defined in the Act of 2000.
Dealing with the issue of the connected function, counsel submits that what is sought to be established is a de novo inquiry into the subject matter of the report.
Dealing with the procedures to be followed by the Commission, counsel refers to the fact that in January of 2002, the Commission indicated the procedures which it proposed following and that there has been no evidence of any dissent having been given with regard to these procedures.
Counsel refers to the provisions of s. 11 para. 3 (a) of the Act of 2000, which provides for meetings to be held otherwise than in public where instances of alleged abuse of children is been given in evidence.
Counsel refers to the fact that the letter of 10th September, 2000, was addressed only to Minister and not to the Commission, as it sought to question the procedures being followed by the Commission. Counsel, therefore, submits that at no time has the Commission been asked to address the issue of its procedures, but that this is a matter that may well arise. Counsel submits that the relief sought against the Commission insofar as it pertains to its procedures is premature. Counsel further submits that the deliberations of the Commission were ongoing and were overtaken by the challenge to the vires of the Additional Functions Order. It is submitted that, in the circumstances, it would have been inappropriate for the Commission to address the question of its procedures having regard to the subsisting challenge to the vires of the inquiry itself. Counsel concedes that, depending on the determination of the issue of vires, the procedures in question may well have to be addressed by the Commission.
In reply, on behalf of the applicant, Mr. O'Donnell indicated that no one was required to accept the categorisation put forward by Dr. Hillary, but that no issue had be taken on the facts as set forth in her affidavit. She had made constructive suggestions and if a different view was taken this could and should have been expressed.
Dealing with the facts which are alleged to be uncontested counsel submitted as follows:-
With regard to the assertion that the first trial was conducted within the norms of the time counsel submits that this is supported by portions of the expert reports which purport to say so. With regard to the second assertion that no one was injured, counsel refers to the fact that nowhere in the report of the Chief Medical Officer is there any suggestion that any one suffered any injury or harm and this is a fact that is referred to in the judgments of members of the Supreme Court in the Meenan case. In this regard, counsel also refers to portions of reports of Dr. Miller who at p. 4 of her report stated, inter alia,
"the children were not exploited in any way and none suffered ill effects; on the contrary, their protection against poliomyelitis was confirmed according to the protocol of the trials".
Further, in regard to the report of Dr. David Hull, in his conclusions he refers to the fact that none of the children was reported to have had a significant adverse reaction to either vaccine and with regard to the obtaining of blood, he concluded that this procedure carried a minimal risk only and he refers to the fact that no infant was reported to have come to any harm. Thirdly, with regard to the assertion that no one claims to have suffered abuse, counsel refers to portion of the judgment of the Chief Justice in the Meenan case at p. 11 and to the judgment of Hardiman J. at p. 6.
With regard to the assertion that the mean average age of the children was twenty two months, counsel corrects this by indicating that this should have stated twenty two weeks as referred to at p. 1099 of the report published in the British Medical Journal exhibited by the applicant.
With regard to the assertion that no child or institution comes within the remit of both the Vaccine Trials Division and the general abuse inquiry, counsel submits that there is no evidence to the contrary. Finally, with regard to the existence of General Medical Council guidelines, counsel refers to the exhibits and a document apparently signed by Dr. James Kiely recording a conversation with the GMC in London on 9th July, 1997 to the effect that in 1960 as then there were broad general ethical guidelines as to what constituted good medical practice but no specific guidelines relating to the organisation and conduct of clinical/therapeutic trials.
In reference to the vires of the Government in making the impugned order, counsel refers to portion of the judgment of O'Higgins C.J. at p. 399 in City View Press v. An Chomhairle Oiliúna  I.R. 381, where he stated, having referred to the safeguard of parliamentary control of delegated legislation:-
"Nevertheless, the ultimate responsibility rests with the courts to ensure that constitutional safeguards remain, and that the exclusive authority of the National Parliament in the field of law making is not eroded by delegation of power which is neither contemplated nor permitted by the Constitution. In discharging that responsibility, the courts will have regard to where and by what authority the law in question purports to have been made. In the view of this court, the test is whether that which is challenged as an unauthorised delegation of parliamentary power is more than a mere giving effect to principles and policies which are contained in the statute itself. If it would be, then it is not authorised; for such would constitute a purported exercise of legislative power by authority which is not permitted to do so under the Constitution. On the other hand, if it be within the permitted limits – if the law is laid down in the statute and details only are filled in or completed by the designated Minister or subordinate body – there is no unauthorised delegation of legislative power."
Counsel refers to the case of Cassidy v. Minister for Industry  I.R. 297 and refers to the fact that evidence was given in that case is support of the impugned order. Counsel submits that there was no attempt to hide behind any presumption. With regard to the reviewablity of the decision of the Government, counsel submits that no exercise created by a statute is beyond the review of the courts. Counsel refers to the issue as to whether rights of an applicant can be affected by the findings of an inquiry and submits that it cannot be said that an inquiry cannot affect rights. In this regard, counsel refers to the authority of In Re Haughey  I.R. 217. In this regard counsel refers to portion of the judgment of Ó Dálaigh C.J. at p. 264 of the report where he stated inter alia,
"…but in proceedings before any tribunal where a party to the proceedings is on risk of having his good name, or his person or property, or any of his personal rights jeopardised, the proceedings may be correctly classed as proceedings which may affect his rights, and in compliance with the Constitution the State, either by its enactments or through the courts, must outlaw any procedures which will restrict or prevent the party concerned from vindicating these rights."
Counsels submits that in the absence of any evidence from the respondents there has been an inadequacy of any explanation given before the impugned decision of the Government. Counsel further submits that no presumption of constitutionality can obtain in the instant case. Counsel poses the question 'What particular decision did the Government make?'. Counsel submits that this is an unresolved question. Counsel submits that one cannot presume in the first place that the Government decided that there was a connection between the subject matter of the vaccine trials and the existing function of the Commission and furthermore, one cannot presume that the decision of the Government was arrived at by an intra vires application of s. 4 (4) of the Act of 2000. Counsel submits that one cannot assume the facts in favour of the respondent.
Counsel submits in reference to the position of the Commission that it is under no constraint and could indicate the existence of evidence which it has, which may be of some possible import to the issue raised in these proceedings and referred in the judgments of members of the Supreme Court in the Meenan case.
In reference to the Therapeutic Substances Act, 1932, counsel submits that the provisions of that Act relate to the importation of drugs. While the vaccines administered in the vaccine trials may not have been standard, it cannot be said that the vaccines were experimental in pharmaceutical terms, as the essential issue was the combination of vaccines and in this regard the components which were parts of the vaccines cannot be said to be other than standard.
Finally, with regard to the issue of delay counsel refers to the fact that in the case of Farrell v. Eastern Health Board a delay of two years was in existence. Counsel submits that in the instant case an estoppel cannot be the basis of the Commission continuing if the impugned order is one which should not have been made by the Government.
In the first place it is clear that the central issue sought to be raised in these proceedings is one of particular importance and while the issue of the vires of the Government to make the Additional Functions Order is one that could have been raised at an earlier stage, it is also clear, having regard to the focus on this issue in the obiter pronouncements of the Chief Justice and Hardiman J. in the Meenan case, that the issue took on a fresh significance for the applicant who has moved promptly since that time. While I am conscious of the judgments of the Supreme Court in De Róiste v. Minister for Defence  1 IR 190 and the need to move promptly under O. 84 r. 21 (1) of the Rules of the Superior Courts and that in the context of any extension of time the applicant show should good reason why the time should be extended, I am satisfied that the approach taken by Geoghegan J. in Eastern Health Board v. Farrell  1 ILRM 446 is one that should apply in the instant case and that I should consider the questions of time in light of the overall importance of the case, which does not simply relate to the circumstances of the applicant.
I have considered the submissions made by counsel for the State parties in regard to the basis for the making of the impugned Additional Functions Order. I am satisfied that in the absence of any additional evidence being put before this court, that I must judge the vires of the order by reference to the terms of the order itself and the report of the Chief Medical Officer which is expressly mentioned therein.
In considering the report itself and the passages opened by counsel, I am satisfied that nothing disclosed therein suggests that the conduct of the trials, the subject of the report, was such that they can be said in any way to amount to 'abuse' as defined in the Act of 2000. I am conscious of the fact that that term is widely defined in the Act, but is is clear that none of the issues raised in the report of the Chief Medical Officer even suggest the existence of abuse as so defined in the conduct of the trials in question. The issue therefore remains whether anything else referred to in the report or in the impugned order can be said to show in the terms of s. 4 (4) that the additional functions sought to be conferred by the Additional Functions Order are 'connected with' the functions and powers of the Commission as they then stood at the time of the making of the Additional Functions Order. I have been unable to discern anything which remotely could be said to be connected with the pre-existing powers and functions of the Commission, other than the matters identified by counsel, namely, that the persons in question, the subjects of the trials, were in State institutions and they were children. I am satisfied that the mere fact that they were vulnerable children in such institutions is not such as to amount to any connection of substance enabling the making of the Additional Functions Order. I am satisfied that the use of the term "tenuous", used by Keane C.J. in his judgment in the Meenan case, is an apt description of the situation. I believe that there must be some real connection before an additional functions order can be made and it is idle to speculate whether any of the children, the subject of the vaccine trials, may ever have been the subject of any abuse as defined in the Act of 2000.
While I am conscious of the issues referred to by counsel both for the State respondents and the Commission as identified from the report of the Chief Medical Officer, I am satisfied, that at its height it does not suggest any connection, as required by the subsection, such as to entitle the making of an additional functions order in the circumstances of this case.
I am satisfied that the decision of the Government cannot be adjudicated upon on the basis of material that came into existence after the making of the Additional Functions Order. At the same time I accept, as accepted by the applicant herself, that other machinery may exist for an appropriate enquiry into the matters identified by the Chief Medical Officer and addressed in the subsequent reports, including those commissioned by the Commission itself and the legal representatives of the children the subject of the vaccine trials. The essential issue raised is one of medical ethics and is not one suggestive of 'abuse' as defined in the Act of 2000. In this regard, I reject the contention put forward by the respondents to suggest that the report supports the fact that abuse may have occurred. I am satisfied that nothing in the evidence put before this court suggests such to be the case, in light of the definition of same appearing in the Act of 2000.
In all the circumstances I am satisfied that the Additional Functions Order was made ultra vires s. 4 (4) (a) of the Act of 2000.
I am satisfied that the approval of the Additional Functions Order by both Houses of the Oireachtas was not such as to validate the making of the Order itself, which could only be made within the limits of the section itself.
With regard to the further relief sought by the applicant against the Commission, with particular regard to the procedures to be followed by it, I am satisfied that the issue was one addressed to the Government and the State parties in the letter of the 10th September, 2003, and not addressed to the Commission. I am not satisfied that the Commission has committed itself to follow any particular procedure such as would violate the applicant's rights. I believe that if the matter had been specifically addressed to the Commission and it had made a determination to follow procedures which were unwarranted and in violation of the applicant's rights, that this Court could intervene to restrain same. However, I accept the submission made by counsel on behalf of the Commission to the effect that the issue was not addressed to the Commission and is premature. It is clear that the Commission acted to enable the applicant to take these proceedings to this Court and did not seek to adopt any particular stance with regard to the procedures to be followed.
In holding against the State respondents, I wish to emphasise that I make my determination on the basis of the terms of the Act of 2000 and not on the basis of any perception of the powers contained in that Act. The decision of this Court is not to be construed as suggesting that there may not be issues relating to the report of the Chief Medical Officer, which might be the subject of an appropriate form of enquiry in light of the applicant's own stance in these proceedings and the points made on her behalf in the correspondence addressed to the respondents following the decision in the Meenan case.
The relief which the applicant seeks is clearly discretionary in nature and the delay complained of is a matter which may be taken into account by this Court in its determination of this application. I am satisfied that in all the circumstances of this case it would be unreal to refuse the applicant the relief which she seeks on the basis of the delay complained of, in light of the fundamental defect identified in the Additional Functions Order. Accordingly, while I refuse the relief sought against the Commission, I am satisfied that the applicant has established an entitlement to the primary declaration sought by her and I will hear counsel in relation to any form of order that should be made by this Court.