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Dáil Éireann debate -
Wednesday, 2 Jun 1999

Vol. 505 No. 7

Tribunal of Inquiry into HIV and Hepatitis C Infection: Motion.

Minister of State at the Department of Health and Children (Dr. Moffatt): I move: "That Dáil Éireann:
Bearing in mind the serious public concern about–
(a)the contamination of relevant products with HIV and hepatitis C,
(b)the number of infected persons, and
(c)the consequences of infection for the health of those persons,
RESOLVES that it is expedient that a tribunal be established under the Tribunals of Inquiry (Evidence) Act, 1921, as adapted by or under subsequent enactments and amended by the Tribunals of Inquiry (Evidence) (Amendment) Act, 1979, the Tribunals of Inquiry (Evidence) (Amendment) Act, 1997, and the Tribunals of Inquiry (Evidence) (Amendment) (No. 2) Act, 1998, to inquire urgently into, and report to the Clerk of Dáil Éireann and make such findings and recommendations as it sees fit in relation to, the following definite matters of urgent public importance:
(1)which relevant products caused, or probably caused, the infection,
(2)the adequacy of the criteria, standards and procedures applied by the Board for the purposes of its processing and manufacture of any relevant products found by the Tribunal to have or probably to have caused the infaction with regard to–
(a)donor selection,
(b)donor screening,
(c)donor testing,
(d)plasma quarantine,
(e)virus inactivation,
(f)product recall,
and the timeliness of the application of such criteria, standards, and procedures,
(3)the adequacy and timeliness of the decisions of the Board and other relevant persons in the State in the selection of any relevant products found by the Tribunal to have or probably to have caused the infection,
(4)the considerations that influenced the Board when deciding to implement a policy of self-sufficiency by using plasma collected or recovered within the State for the processing or manufacture by it or the manufacture by other manufacturers of relevant prod ucts, and the adequacy and timeliness of the implementation of that policy,
(5)the considerations that influenced the decisions of the Board and other relevant persons in the State in the selection of the manufacturers of any relevant products found by the Tribunal to have or probably to have caused the infection and the adequacy of the criteria, standards and procedures applied by those persons in such selection with regard to–
(a)donor selection,
(b)donor screening,
(c)donor testing,
(d)plasma quarantine,
(e)virus inactivation,
(f)product recall,
on the part of the manufacturers of those products and the timeliness of such application,
(6)the time when the Board and other relevant persons in the State became aware, or ought reasonably to have become aware, that relevant products had become, or that there was a risk that they would become, a source of infection,
(7)the adequacy and timeliness of the response of the Board and other relevant persons in the State to their becoming aware of the matters referred to in subparagraph (6) and, in particular (but without prejudice to the generality of the foregoing)–
(a)the actions taken by the Board and those persons to identify persons likely to have been affected by the matters aforesaid, to inform them of those matters and to offer them HIV or hepatitis C testing, and
(b)the action taken by the Board and those persons to reduce or minimise the risk of infection having regard to those matters,
(8)the adequacy and timeliness of the response of the Minister, the Department of Health and Children, and other relevant persons in the State, when they became aware of the fact that there were infected persons,
(9)the adequacy of the donor selection and donor screening procedures that–
(a)were employed by the Board from and including the year 1980 to and including the month of October, 1985, and
(b)were intended to exclude potential donors who had, or might have been exposed to infection with, HIV,
(10)whether the introduction by the Board in the month of October, 1985, of donor testing for HIV was timely, having regard to international experience and any other relevant circumstances,
(11)in respect of recipients of whole blood, blood components and blood products derived from donations made in the State prior to the introduction of HIV testing in the month of October, 1985, by donors who were subsequently diagnosed as positive for HIV, the adequacy and timeliness of the procedures adopted by the Board to identify those recipients,
(12)the circumstances surrounding the issue by the Board on an emergency basis in the month of December 1985, of untested platelet concentrate and the adequacy of the response of the Board when the donor of the platelets was subsequently diagnosed as positive for HIV,
(13)in respect of any relevant products found by the Tribunal to have or probably to have caused the infection, whether the Minister, the Department of Health and Children, the National Drugs Advisory Board and any other relevant person, carried out his, her or its functions (including, in the case of the National Drugs Advisory Board, advising the Minister on the granting of Product Authorisations and Licences for the manufacture, importation, distribution or sale of such products) adequately and properly and whether those functions were the appropriate ones having regard to international standards,
(14)whether the supervision by the Minister of the Board and the National Drugs Advisory Board, in so far as relevant to any matter referred to in the foregoing subparagraphs was adequate and appropriate having regard to the functions, duties and responsibilities of the Minister, and for the purposes of the inquiry the Tribunal shall investigate anything arising outside the State that it considers relevant to any of the matters set out in the foregoing subparagraphs in so far as the Tribunal considers it practicable, appropriate and reasonable to do so and considers that the procedures adopted for that purpose can be carried out without unduly delaying the completion of the inquiry and with a substantial expectation of being able to obtain the evidence necessary for the investigation.
AND FURTHER RESOLVES that–
(I)in performing its functions, the Tribunal shall have due regard to relevant medical and scientific opinion and practice prevailing at the relevant times,
(II)bearing in mind the desirability that the interests of persons with haemophilia, their immediate families, and their next of kin, who wish to be represented at the Tribunal by the Irish Haemophilia Society ('the Society') should, if possible, be so represented, the Tribunal shall, if it is satisfied that it is just and convenient to do so, accede to any application made by or on behalf of the Society for such representation and the Tribunal shall in its discretion determine whether such representation should be full or limited,
(III)the Tribunal shall report to the Clerk of Dáil Éireann on an interim basis not later than four months from the date of establishment of the Tribunal and also as soon as reasonably may be after the tenth day of any oral hearings of the Tribunal on the following matters:
(a)the number of parties then represented before the Tribunal,
(b)the progress which will then have been made in the hearings and the work of the Tribunal,
(c)the likely duration, (so far as that may then be capable of of being estimated) of the proceedings of the Tribunal,
(d)any other matters that the Tribunal considers should be drawn to the attention of the Houses of the Oireachtas at the time of the report (including any matter relating to its terms of reference),
(IV)the inquiry shall be completed in as economical a manner as possible and at the earliest date consistent with a fair examination of the matters referred to it,
(V)all persons employed in the Departments of State and State agencies concerned shall give their full co-operation to the Tribunal and those Departments of State and agencies shall themselves fully co-operate with the Tribunal by providing it with all the documents and information requested of them that are in their possession or power, and
(VI)the anonymity of persons with haemophilia and their next of kin shall be preserved, if they so wish unless the Tribunal considers it would be unjust to do so.
In this resolution—
‘infected person' means a person with haemophilia or any other blood clotting disorder who has been infected with HIV or hepatitis C through the administration in the State of a relevant product, and 'infection' shall be construed accordingly;
‘the Minister' means the Minister for Health and Children;
‘person' includes a body corporate and an unincorporated body of persons as well as an individual;
‘relevant product' means a blood product or a blood component for administration to persons in the State to treat them for haemophilia or other blood clotting disorders in respect of those conditions;
‘the Board' means the Blood Transfusion Service Board."
The main purpose of this motion is to authorise the establishment of a tribunal of inquiry to investigate the infection of persons with haemophilia, and related matters. The Fianna Fáil manifesto contained a commitment to establish an inquiry into the hepatitis C infection of persons with haemophilia, and into the HIV contamination of blood and blood products and I am pleased to be in a position to give effect to this commitment today. The tribunal will investigate a number of matters related to blood and blood products that do not directly affect persons with haemophilia and I will elaborate on these in due course.
Shortly after taking up office, I met the Irish Haemophilia Society which represents haemophiliacs and their families who have been directly affected by the contamination of blood products with HIV and hepatitis C. Haemophilia is a blood clotting disorder caused by deficiencies in blood coagulation factors. The proposed terms of reference for the tribunal cover persons with haemophilia and other blood clotting disorders, such as Von Willebrands disease, who have been infected with HIV and hepatitis C.
The treatment for factor deficiencies consists of replacing the missing factors with blood derivatives to allow normal clot formation and thus avoid haemorrhage. Persons with blood clotting disorders are not only frequent users of blood products but also are reliant totally on blood products for their quality of life. The Minister was pleased to authorise the replacement of plasma derived Factor 8 product with a synthetic or recombinant product in September 1997. Recombinant Factor 9 has recently become available.
The viral infection of blood products is a crucial issue for the Irish Haemophilia Society and its members, who relied and continue to rely on the society so much. The society had hoped that the infection of its members would have been investigated by the tribunal of inquiry chaired by Mr. Justice Finlay. The tribunal took the view, however, that its terms of reference precluded it from investigating the hepatitis C infection of persons with haemophilia. It also took the view that it would not have been practical to extend the terms of reference of its inquiry to include these matters. As a result, the society withdrew from the tribunal on 15 January 1997 on the grounds that the issues of concern to it and its members were not being addressed.
It was imperative to avoid a repetition of these events. For that reason the Minister entered into consultations with the society with a view to identifying the issues of public importance which required investigation by the tribunal. This has proved a long and difficult process. I reject, however, any suggestion that the Minister or his officials have been seeking to delay the establishment of the tribunal.
In preparing the terms of reference the Government's approach has been to ensure that the terms of reference would allow the tribunal to discharge its task efficiently and effectively; the tribunal was workable and that the terms would cover matters which were capable of being investigated; the tribunal was not required to embark on a long drawn out inquiry with little expectation of a useful outcome and that fair procedure issues were properly addressed.
Having regard to our experience in recent years with various tribunals of inquiry, the House will agree it is essential that a tribunal is given terms of reference that are reasonably clear and unambiguous. It is far better to spend some time preparing workable terms of reference than to establish a tribunal with an unclear mandate that may run into the sand.
Among the complex issues that arise in the present context are the fact that, unlike the Finlay tribunal, the proposed tribunal will investigate matters relating to two different infections, hepatitis C and HIV, and that it will deal not with one blood product but a number of products and blood components. Some of the products were manufactured here, others abroad. Some were manufactured abroad using plasma donated here.
It was the international dimension of the matter that proved the most difficult and complex aspect in the preparation of the terms of reference. As it appears that most blood products implicated in the infection were manufactured abroad, the question arose as to whether the tribunal should inquire into the relevant operations of the pharmaceutical companies concerned. It was necessary for the Minister to take legal advice on the extra-territorial jurisdiction of an Irish tribunal. Senior counsel's advice was obtained. It was also necessary to seek advice from US lawyers.
The advice the Minister received was to the effect that in order for the tribunal to fully investigate the adequacy of the actions of US based pharmaceutical companies it would have to be able to secure the discovery of documents and the attendance of witnesses; as a tribunal is not a court, it is unlikely that US courts would be able to assist by enforcing discovery orders or compelling the attendance of witnesses; if the tribunal was unable to obtain discovery on critical matters from US sources or to take evidence from key witnesses in the US, serious fair procedures issues could arise if Irish witnesses could plausibly assert that they had relied on the US pharmaceutical companies and agencies and that, because of the inability of the tribunal to investigate those companies or agencies, they were being saddled with the entirety of the blame for the medical catastrophes that occurred; any attempt by the tribunal to investigate the actions of US regulatory agencies such as the Food and Drug Administration could give rise to novel problems of jurisdiction with complex legal, political and, possibly, diplomatic ramifications; if such an all-encompassing inquiry were to be set in motion, the tribunal could take up to five years to complete its task with no guarantee that it would succeed in making any substantial progress on the issues surrounding the infection of persons with haemophilia from foreign-sourced products.
Having regard to the legal advice, the practicalities of the situation had to be reflected in the drafting of the terms of reference, otherwise, we would have found ourselves in the position of having a tribunal which was unable to fully complete its examination of the matters referred to it by the Oireachtas. The Irish Haemophilia Society was understandably anxious that the terms of reference would address fully its concerns in relation to the international dimension of the inquiry.
The terms of reference now include a provision which will enable the tribunal to investigate anything arising outside the State that it considers relevant in so far as the tribunal considers it practicable, appropriate and reasonable to do so and considers that the procedures adopted for the purpose can be carried out without unduly delaying the completion of the inquiry and with a substantial expectation of being able to obtain the evidence necessary for the investigation.
The tribunal will examine in particular the decisions taken within the jurisdiction in relation to the importation of blood products found to have caused the infection. It will be open to the tribunal to compare the actions and omissions here with those in other jurisdictions, to hear evidence from international experts, to examine international research and publications, and to seek information and assistance from the US Food and Drug Administration, the US Centre for Disease Control and the pharmaceutical industry.
The drafting of terms of reference which, on the one hand, addressed the concerns of the Irish Haemophilia Society in relation to the investigation of matters arising outside the State and, on the other, reflected the practicalities as set out in the legal advice proved a most difficult and time-consuming task which required intensive input from the Minister, the Attorney General, their officials and the Irish Haemophilia Society. I am pleased that the proposed draft of the terms of reference, as approved by the Government, achieves this objective in a manner which is acceptable to the society. I record my appreciation of the efforts of all concerned.
I will outline the detailed provisions of the terms of reference, the interpretation of which is primarily a matter for the tribunal. I would not want anything I say to be taken as an attempt to interfere with the tribunal in the performance of its functions. It would be helpful to Members, however, to indicate what the terms of reference are intended to achieve.
The first part of the terms of reference includes the substantive matters of public importance which the tribunal will be required to investigate. The tribunal will ascertain, in so far as it is able to do so, which of the blood products administered to persons with haemophilia caused, or probably caused, infection with HIV or hepatitis C. These conclusions are of fundamental importance to the tribunal's investigations and I expect that, when these conclusions have been reached, the tribunal will proceed to examine all the other matters set out in the terms of reference as they relate to the products in question. The products which will be under examination will include all relevant products, that is, products used to treat persons with haemophilia for that condition, whether manufactured or processed within the State or imported from other countries.
With regard to products or components processed or manufactured by the Blood Transfusion Service Board which are found by the tribunal to have caused, or probably caused, infection with HIV or hepatitis C, the tribunal will examine whether the procedures and standards applied by the board at the relevant times were adequate. In examining this and the other substantive issues, the tribunal will take account of the international standards which prevailed at the relevant time. The standards of the time are the benchmark against which procedures such as, for example, donor selection and donor screening, should be examined.
The tribunal will examine the decisions taken by the Blood Transfusion Service Board and by any of the persons within the State involved in choosing the treatment therapies for persons with haemophilia, in relation to whether the therapies were the suitable ones in the light of the information available at the time. It will be for the tribunal to determine what persons in the State are relevant to its inquiries in this and other matters it is investigating.
The tribunal will examine the reasoning behind the decision of the Blood Transfusion Service Board to implement a policy of self-sufficiency, whether the decision was the right one on the basis of the prevailing international standards, and whether the policy itself was implemented in a timely manner. A policy of self-sufficiency means utilising Irish plasma for the manufacture of clotting factor concentrates rather than relying on plasma collected abroad and, subsequently, used for the manufacture of products for use in this country.
With regard to any blood products imported for treatment of persons with haemophilia which are found by the tribunal to have caused, or probably to have caused, infection with HIV or hepatitis C, the tribunal will examine the criteria and standards applied by the BTSB and other persons responsible for deciding which products to import when selecting those products. For example, the tribunal will examine what standards were required in the donor screening procedures applied by the manufacturer of that relevant product. It will also examine the timeliness of the application of these criteria.
The tribunal will investigate when any of the persons relevant to the inquiry first became aware of the risk to persons with haemophilia because of the contamination of blood products. It will also investigate whether those persons should reasonably to have been aware of the risk earlier. It will examine the response of relevant persons when they became aware of the risk to persons with haemophilia, in particular, what actions were taken to identify persons with haemophilia who had been treated with the products concerned, whether they were duly informed of the risk, and whether they were offered hepatitis C and HIV testing when such tests became available. The tribunal will also examine the actions to reduce the risk for persons with haemophilia and will examine whether the response of the Minister for Health and his Department was adequate when they became aware that persons with haemophilia had contracted hepatitis C and HIV through the administration of blood products. Paragraphs (1) to (8) of the terms of reference, as outlined relate specifically to matters relevant to the infection with HIV and hepatitis C of persons with haemophilia. The tribunal will also investigate a number of other matters relating to blood products and components which are not directly relevant to persons with haemophilia.
The tribunal will investigate the circumstances of the infection with HIV of the person known as Mary Murphy, or "the Kilkenny health worker", as a result of receiving a blood transfusion in 1985. Ms Mary Murphy received a transfusion of whole blood in July 1985. The donor in question returned to donate again in September 1986, at which stage it was found that the donor was HIV positive. The donation of September 1986 was discarded, but, regrettably, no lookback was carried out on previous donations given by the donor, including the donation which was administered to Mary Murphy. Accordingly, it was not until 1996 that Ms Murphy discovered that she had contracted the virus, and established the source of her infection.
The issues relevant to Mary Murphy's infection with HIV are encompassed in paragraphs (8), (9) and (10) of the terms of reference as follows: Paragraph (9) – The tribunal will examine the protocols operated by the Blood Transfusion Service Board, prior to the introduction of a HIV test for donors, to try to minimise the risk of HIV-positive donors donating blood. Donor testing for HIV was introduced by the BTSB in October 1985. Ms Murphy received her blood transfusion in July 1985, some months prior to the introduction of the HIV test. Paragraph (10) – The tribunal will examine whether the introduction by the BTSB in October 1985 of a HIV test for donors was timely, having regard to international experience and any other relevant circumstances. Paragraph (11) – The tribunal will examine the adequacy of the actions taken by the BTSB to trace the recipients of previous blood donations from donors who, following the introduction of the HIV test for donors in October 1985, were found to be HIV positive.
I understand that between 1985 and 1989, the BTSB did not conduct lookback procedures in respect of the previous donations of donors who tested HIV positive under the new test, although once the donor tested HIV positive, his or her current donation was discarded. From 1989 onwards, the BTSB had a lookback procedure for newly presenting HIV positive donors, and they updated their lookback procedures in 1993.
Paragraph (12) deals with the second of the non-haemophiliac issues that are to be investigated by the tribunal. This paragraph deals with the release by the BTSB of untested platelet concentrate, which was administered to a particular patient in December 1985, the donor of which was subsequently diagnosed as HIV positive.
This case came to light during the investigations that followed the Mary Murphy case. I understand it was practice for the BTSB to issue untested platelet concentrates in emergency situations because the HIV test at the time was slow, and the short shelf life of platelets – 72 hours at the time – meant there was not time to await the result. All of the donations associated with these platelets were tested on the next testing day and none was confirmed positive for the mandatory markers of the time, including HIV, except for one platelet concentrate issued in December 1985 which tested HIV positive. The tribunal will examine all the circumstances surrounding the issue of this platelet concentrate, including the response of the BTSB when it emerged that the donor was HIV positive.
The tribunal will examine the roles of the Minister, the Department and the National Drugs Advisory Board in relation to any products which are found by the tribunal to have caused, or probably to have caused, the infection with HIV and, hepatitis C of persons with haemophilia, particularly in relation to their respective roles in the granting of product authorisations and licences. The tribunal will also examine whether the statutory functions of the relevant persons were appropriate in themselves, having regard to the prevailing international standards.
The tribunal will examine whether the Minister carried out his functions adequately and appropriately in relation to his supervision of the BTSB and the National Drugs Advisory Board in respect of all matters being examined by the tribunal.
The second part of the terms of reference contains what might be called the procedural terms in that they relate to the manner in which the inquiry is to be carried out rather than to the substantive matters the tribunal will investigate. Section 1 provides that the tribunal shall take account of the scientific opinion and practice which was prevalent at the time when the matter being investigated arose. This section is very important, as the bulk of the matters to be investigated by the tribunal arose more than a decade ago. Subsequent research and knowledge has added significantly to the understanding of the viruses and to improvements in serological testing for virus antigens. It would be most unfair to judge actions at a time when very little was known about a particular virus on the basis of current medical and scientific opinion and practice when so much more knowledge is generally available.
Section 2 recognises the special position of the Irish Haemophilia Society, representing as it does the body of persons directly affected by the HIV and hepatitis C infection of blood products. It would be desirable that the society be granted representation before the tribunal, both to protect the interests of its members and to ensure the tribunal is given the benefit of the society's expert knowledge and experience gained over 30 years of representing persons with haemophilia. However, decisions in respect of representation are entirely at the discretion of the tribunal. This section fully recognises the authority of the tribunal in deciding on representation and whether it should be full or limited.
Section 3 requires the tribunal to make two interim reports, the first not later than four months after its establishment and another after ten days of hearings. I anticipate that when the chairperson of the tribunal is appointed, as well as the various legal teams, a significant lead-in time will be required to allow all concerned to become familiar with the matters to be dealt with by the tribunal, particularly as many of them have detailed scientific and technical aspects. I consider that four months from the date of establishment would be a suitable time for the submission of an interim report giving details of progress to date. By that time I expect the question of representation before the tribunal should be settled.
After ten days of oral hearings the tribunal should be in a position to estimate the likely duration of its proceedings and will report to the Dáil in relation to this and any other matters on an interim basis at that stage. The tribunal might also at that stage have some comment to make on the terms of reference. It is impossible at this stage to estimate how long the tribunal is likely to continue, and it is only when the tribunal has had the opportunity to examine the documentation which will be made available to it that it will be in a position to advise the House in relation to its expected duration.
Section 4 requires the tribunal to examine the matters referred to it economically, efficiently and effectively. Section 5 requires that all persons employed by bodies under the aegis of the State who are relevant to the inquiry to co-operate fully with the tribunal, including providing it with all the documents and information it requests, if it is in their power to do so.
Section 6 requires the tribunal to protect the anonymity of persons with haemophilia, other recipients of whole blood, blood components or blood products, donors, and their next of kin. I expect that the tribunal would only refuse anonymity in exceptional cases, for example, if it was necessary to protect the constitutional rights of third parties. The text of the original motion which was circulated to Deputies referred to the anonymity of persons with haemophilia only. I consider that donors and recipients of other blood components and blood products, including the Kilkenny health worker, should be afforded anonymity in similar circumstances. With the agreement of the Ceann Comhairle, I have circulated the text of a motion which incorporates this clarification.
As I said earlier, the primary purpose of the tribunal is to investigate the infection with HIV and hepatitis C of persons with haemophilia. While the Minister very much regrets the pain and suffering caused to all of those who have been affected by the infection of blood and blood products, the impact on the haemophilia community has been particularly devastating. I am informed by the Irish Haemophilia Society that 210 of its members were infected with hepatitis C between the mid-1970s and 1990. One hundred and three persons with haemophilia were infected with HIV during the 1980s. Given that haemophilia is an inherited condition, a relatively small number of families have been affected. However, the toll in human lives has been great, with a total of 67 people, including a number of children, dying as a result of their infection with these viruses. The loss of so many people, particularly the loss of children, is a tragedy of immense proportions. The loss of fathers, sons and brothers is still deeply felt by their families and friends and the passage of time has not served to diminish the strength of their feelings. The bereaved families consider that there are many questions which need to be answered concerning the cause of the infections and whether they could have been avoided. I am satisfied that the terms of reference for the tribunal will enable it to address these questions and, hopefully, assist the families in finally coming to terms with their loss. I commend the motion to the House.

I welcome the fact that the motion is before the House. The previous Minister for Health, Deputy Noonan, gave a commitment that such a tribunal would be established. When the current Government came into office it was not envisaged that it would take so long for the terms of reference to be agreed. It is of substantial importance that the Irish Haemophilia Society was involved in discussions with the Government and, in particular, with the Department of Health and Children, concerning the details of the terms of reference. The society deserves much praise for the work it has done and the extraordinarily restrained way in which it has carried it out. At no stage has the society attempted to make the length of time it has taken to establish the tribunal a political issue between political parties. My understanding is that the society has largely dealt with officials of the Minister's Department. It is noteworthy that it was only in a letter dated 14 May that, for the first time, the society complained in particular to Members of the House about the time it was taking to agree the terms of reference. Subsequent to that letter being received by Members whatever difficulties existed between the society and departmental officials were resolved. There is nothing to be gained by dwelling on this matter, other than to say that it should have proved possible to have agreed these terms of reference somewhat earlier, although I appreciate the complexity of the legal difficulties, particularly in dealing with pharmaceutical companies outside the State.

Fine Gael welcomes the motion and will not raise objections to it or seek to have it amended. The only issue I wished to raise was that referred to by the Minister of State, Dr. Moffatt, namely, the extension of anonymity to all those who come before the tribunal. The Minister has circulated amended terms of reference dealing with this issue in a proper and welcome manner.

The history of this issue is one of a major tragedy and events befalling people which should not have happened. Without prejudging the findings of the tribunal, I find it completely inexplicable that the BTSB failed to conduct the look-back programme in the 1980s, referred to by the Minister, upon discovering the difficulties which existed with the blood product. The great tragedy is that since these difficulties were discovered only two people in this country, as I understand it, have died as a result of haemophilia while during the same period there have been 67 deaths of haemophiliacs who were the recipients of defective blood products, 103 people have been infected with HIV and 210 people have been infected with hepatitis C. It must be acknowledged that a State agency grossly failed these people, failed to ensure the safety of the blood products it was providing and, even more extraordinarily, on discovering the particular donors were not suitable, failed to conduct a lookback programme to ascertain who had been administered blood products derived from those donors at an earlier stage.

There are two or three issues I want to raise with the Minister in a constructive way. There is a reference to the difficulties on which the Minister sought advice concerning the pharmaceutical companies which supplied blood product from outside the State. There is also a reference to the tribunal being able to seek information and assistance from the US Food and Drug Administration and the US Centre for Disease Control, as well as the pharmaceutical industry. In his reply I ask the Minister to indicate, apart from the legal advice which he obtained concerning the difficulties which the tribunal could experience in this regard, whether there has been any direct contact between the Minister or his Department with the relevant pharmaceutical companies concerned which are readily identifiable? Has there been a communication with them in advance of these terms of reference coming before this House to ask whether they will co-operate with the tribunal? Will they voluntarily present to the tribunal all relevant documentation it seeks? Will they provide witnesses to the tribunal? I think we are entitled to clarification of that matter.

There is preliminary ground work which the Department could have done in advance of the establishment of the tribunal which would clarify the position in this regard. It may be that such ground work has been done and if it has, the House should be told. If it has not been done, we should be told why not. It is a basic and important issue in terms of getting at the truth of the events which occurred. For example, have we been told by any of these pharmaceutical companies that they will not co-operate? What contacts have there been with the US Food and Drug Administration and the Centre for Disease Control in advance of the motion coming before the House to indicate the extent to which they will facilitate the tribunal by presenting evidence or documentation to it or by nominating persons to give evidence to it. Perhaps the Minister will clarify that because I could see the tribunal, with all its best endeavours, becoming long and drawn out if no preliminary ground work has been done in these areas by the Department because the tribunal will be coming to it completely anew.

Another considerably important issue relevant not just to this tribunal but to the Finlay tribunal and some of the inquiries which have been conducted in the child abuse area, is that the law is deficient in so far as there are no specific criminal offences prescribed which could result in the indictment of public bodies or officials who either recklessly or with gross negligence carry out their duties to the detriment of the community. For example, prosecutions have been brought in France as a result of the supply of contaminated blood products. In Spain there is particular legislation in this regard. I am not saying such legislation could apply retrospectively – I do not believe it can because there is a constitutional difficulty in that regard.

The time has come, however, when we must recognise that there are a number of different bodies in the State who provide fundamentally important services to the community. The community relies on their insight and expertise in the provision of those services. I am not saying that people will not, on occasion, make mistakes but there is a difference between a minor error and a body exercising its important functions recklessly or with gross negligence. There is a difference between a body getting something slightly wrong and which has no particularly detrimental impact on anyone, and a body discovering that a product, which it has made available to the community and which it withdraws, could have caused life-threatening illness to people to whom it has already been administered.

We need a new criminal legislative provision so that it is a particular criminal offence for a public body or an individual employed by a public body either to act recklessly or with gross negligence in carrying out the duties for which the body is formed in a manner which causes serious injury to those to whom the body has an obligation to serve. I ask the Minister the extent to which the Government has considered the possibility of changing the law in this area for the future. It should be clear to people acting in a public function that, where what they are doing could cause a risk to life or limb and where they do not do it with a reasonable degree of care and act recklessly or with gross negligence, they may be liable to criminal and not just civil sanction. We should move towards the type of legal provision which exists in other EU countries, even if it does not exist in the UK. It is an important change which we need to make.

I welcome the establishment of the tribunal. The Minister of State said the tribunal should be functioning by the autumn. How soon will the Government nominate a member of the Judiciary to this tribunal? Will we know that in advance of the summer vacation? In the context of someone being nominated, is there a possibility, as is always necessary in such tribunals, that the tribunal could hold its initial sitting prior to the summer vacation so that it can make decisions about its procedural approaches and any legal assistance which may be required? I want the Minister to clarify, in the context of the establish ment of the tribunal and the work it must undertake, whether it will have the assistance of additional lawyers other than the judge appointed to sit on it? Will the tribunal simply receive evidence or will it have available to it any specialist medical assistance to which the person sitting on the tribunal may wish to turn to have particular issues clarified? It would be important that we know the Minister's thinking in these particular areas.

I welcome the terms of reference. I hope it proves possible for the tribunal to carry out its functions speedily. I have reservations about the fact that, according to the Minister of State, the tribunal will not meet until the autumn. It is important that the tribunal sits before the traditional legal vacation period, which starts in August. The tribunal should at least commence a process of obtaining submissions, inform the general public of when it intends to sit and list the witnesses and other individuals who may come before it. I am not optimistic that it will prove possible for the tribunal to complete its work this year, but it is in the interests of everyone concerned that it completes it work as speedily as possible because it has taken a considerable time to agree the terms of reference and to establish it.

I welcome and support the motion. I congratulate the Irish Haemophilia Society and its members, those living with haemophilia and those who have lost loved ones who were haemophiliacs. Their's has been a long, hard and drawn out struggle which goes back over the past 14 years or so. The past two and a half years have been spent in negotiations with the Government, even though the decision had already been made by the previous Government to establish a tribunal of inquiry to ascertain the truth about the circumstances surrounding the infection of people with haemophilia. I welcome the outcome of all that work, effort, anguish and pain.

The infection of haemophiliacs with AIDS and hepatitis C has rightly been described as one of the worst health catastrophes ever to occur in the history of the State. Out of a total population of just over 400 people, 103 people with haemophilia were infected with HIV. Tragically, 59 of these people have died from factors arising from their HIV infection. Almost all the children infected with HIV have died. Approximately 260 members of the Irish Haemophilia Society have become infected with either HIV or hepatitis C or both. Eight people with haemophilia have died from factors arising from hepatitis C infection. Over the past 16 years, 69 people with haemophilia have died, 67 of whom died as a result of the medical treatment they received. Given the inherited nature of haemophilia, this devastating death toll included sons, brothers, cousins and grandchildren from the same extended families.

A haemophilia community is inevitably a small one and behind the grim statistics lies a story of decimated families, destroyed lives and immeasurable suffering, which will undoubtedly unfold during the course of the tribunal of inquiry. It is a terrible irony that the source of this suffering was hailed as a wonder drug at the time. It offered the hope of life but turned out, in reality, to be a death sentence for many people. These people and their families are entitled to know how and why the disaster happened and who was responsible for it. Specific issues in relation to the safety of blood products require answers – why, for example, certain people with haemophilia appear to have become infected at an inappropriate time in light of the current medical and international standards applicable and why, although commercially obtained concentrates from the plasma of paid donors were first suspected of carrying the HIV virus as early as 1982, these products continued to be supplied to Irish people with haemophilia. Alternative treatment options should have been made available which could have minimised the risk of further HIV infection. Ireland only pursued a policy of self-sufficiency relating to blood products derived from Irish plasma in 1986, subsequent to the time period when commercially obtained blood products were already safe from HIV infection. Why did this happen? The tribunal must answer these questions.

Many members of the Irish Haemophilia Society have had to endure this tragedy in silence and isolation, without the comfort or possibility of knowing what went wrong and without the comfort of knowing that these mistakes will never be repeated. The tribunal of inquiry is designed to provide that security and information. However, we should not underestimate the impact it will have on people who are trying to get on with their lives. It will be difficult for families and haemophiliacs themselves to participate in the tribunal. The tribunal will be traumatic and demanding for people who have already suffered unbearably. For many it will mean reliving the tragedy of their lives and will require the kind of fortitude which has characterised their campaign for truth from the very beginning.

Living with viral infections has been a devastating experience for the people involved. People have lived with sickness and death. Yet, the Irish Haemophilia Society had to struggle on their behalf to obtain commitments from the State on health care facilities for those who contracted HIV and to recompense in monetary terms those afflicted with HIV and AIDS for basic facilities. The compensation package amounted to approximately £7.7 million and was offered at a most difficult time for members of the Irish Haemophilia Society. At that time, the society was required to deal with members coming to terms with their HIV diagnosis, deteriorating health, death and bereavement. It is only right that what was seen as the best option against such a backdrop, where people were dying or very ill, is now being revisited.

The Government has given a welcome commitment to review the adequacy of the compensation package to ensure a fair and equitable settlement. It must also be a swift settlement as we are dealing in many cases with a race against time. There must not be a repeat of the two and a half year delay experienced in getting to this point in regard to the terms of reference. I understand that a simple change in legislation may be all that is required in regard to the issue of compensation, but it is vital that the Minister expresses a determination to deal with this issue fairly, which he has done, and to commit himself to a speedy settlement. I regret that the issue of compensation was not mentioned in the Minister's speech. However, I am aware that at the same time the Cabinet agreed the draft terms of reference, a decision was also made to reopen the compensation issue.

We must remember that further practical issues impact on daily life for these people. It is impossible, for example, for them to obtain life assurance or mortgage protection insurance to protect their homes and families. There is the fear of being shunned in their neighbourhoods arising from the prejudice which may exist with regard to these viral infections. The have had to face the stigmatisation and hysteria prevalent, especially in the 1980s, about HIV and, latterly, about hepatitis C. They face the fear of transmission of HIV and hepatitis C to partners and must suffer the financial consequences arising from the inability to work due to adverse health.

These are the daily realities with which people with haemophilia live. The history of the manner in which the State has dealt with them goes as far back as the fall of the Fianna Fáil Government under Charles J. Haughey over the refusal to compensate people for basic living requirements. It has taken until now, many years and many deaths later, for the tribunal's terms of reference to be published.

It is important that the correct decisions are made this time. We know now that the terms of reference of the Finlay tribunal of inquiry were flawed because they failed to encapsulate investigation of the circumstances of infection of people with haemophilia with hepatitis C. The Irish Haemophilia Society was forced to walk out of that inquiry and an assurance was given by the former Minister for Health, Deputy Noonan, that this tribunal of inquiry would be established in recognition of the needs of the society's members. We must be certain that this tribunal achieves what it sets out to do and that its recommendations, when made, are acted upon. That principle must apply regardless of how difficult the task may be.

The legal difficulties which made the Department of Health loath to include in the terms of reference any investigation of pharmaceutical companies based in the US which manufactured most of the blood products implicated in the infection of haemophiliacs are understood generally. The Minister has allowed for this investigation in the terms of reference but only as far as is "practicable, appropriate and reasonable and without undue delaying of the completion of the inquiry". It is vital that this caveat does not mean any lack of aggressive investigation of the international dimension. Finding the truth will require resolute analysis of products which came into the country and, if necessary, will require legal action to obtain evidence as to their origins. We are all agreed that the tribunal of inquiry should not incur unnecessary delays and, for very understandable reasons, the families want it to complete its work within a reasonable time. That said, the tribunal must not give up easily in discovering the truth about all aspects of this disaster, including the international one.

We should bear in mind what happened when Canadian haemophiliacs sought investigation into the export of tainted blood plasma from Arkansas and Louisiana in the 1980s. The Krever Commission, set up in Canada in 1995, found that much of the tainted plasma came from Cummins prison in Arkansas. The inmates' blood was sold to a company called Health Management Associates which ran the prison plasma programme until 1994, the very existence of which was denied by prison officials and the sales from which were barred from the domestic market by the FDA because they were not found to be safe. Interestingly, Mr. Bill Clinton was Governor of Arkansas at the time. The blood products were, however, sold throughout the world, perhaps even here in Ireland.

In Cummins prison even when the existence of AIDS and hepatitis C was recognised and tests for them became available they were not always used. The FDA discovered that one hepatitis testing laboratory was out of action for two months. Needles were often dirty and many inmates now claim to have been infected as they gave blood. In the early 1980s, the centre was accused of numerous violations and ordered to close temporarily, but the company in the prison continued to sell blood, especially to a company called Connaught, a Canadian company that is under investigation as to whether it sold this plasma world-wide. Canadian haemophiliacs have already taken legal action against the Canadian government and the companies involved, and they are now setting about filing a law suit against the state of Arkansas and Louisiana, their prison systems and even the FDA. We should not be any less diligent. Tracing the infection, the links in that chain and tracing responsibility is a central part of the tribunal's work. I look to the tribunal to pursue this international aspect with vigour.

In this regard, it would be helpful if the Minister would state publicly – he may reply at the end of this debate – that all documentation in his Department will be made available to people with haemophilia and their representative body. I ask that he give a similar commitment on disclosure by the BTSB. Already the experience has been that documentation has not been released by the BTSB to the Irish Haemophilia Society despite the welcome declarations from the BTSB of a new openness and accountability. The prac tice contradicts that declaration and the Minister should state publicly his view on that.

In terms of any recommendations arising from the report, it is worth noting that despite the Government commitment in its programme for Government to fully implement the Finlay report, two of its recommendations have not yet been implemented. Mr. Justice Finlay recommended that the law be changed to oblige doctors to report adverse reactions to blood products. Instead of this necessary and practical form of mandatory reporting, the Government has opted for a voluntary code which is not what was recommended. He also recommended the establishment of a blood service users council, a good, unambiguous provision, yet the Government wriggled out of this by not delivering on this other crucial recommendation. I believe the Minister intends to ensure – but he needs to state this publicly – that the inquiry is efficient, fair and, most importantly, effective and that recommendations made will be delivered upon.

Since compensation is an important part of the negotiations held with the Irish Haemophilia Society, I ask the Minister to tell us also if the State intends to appeal the recent court decision to award £100,000 to a victim of hepatitis C who chose to go the court route. Obviously this has implications in terms of compensation.

When we consider what has happened to people living with haemophilia, the heartbreak experienced by them in these circumstances can only be imagined. None of us can know precisely what it is like unless we have experienced it ourselves. That experience has often been compounded, however, by mishandling and inadequacy within the health services. One parent I spoke to told me that his two children were diagnosed as having hepatitis C two years before he and his wife were informed of the fact. It is incredible that this should have happened, but it did and the information was given in a way that was casual and very unsatisfactory. He was told on his own. The normal support and counselling one would expect was not made available to the couple. He described it as follows:

I felt angry at what had happened to my children, that was bad. But I felt even more angry at the way I was told, the delay [of two years] in telling us and even then at the lack of support and counselling.

It is inexcusable and inexplicable that any family should have suffered so much, but it happened and it is on the record.

After a period in excess of two years of protracted and detailed negotiations on the terms of reference for this inquiry, we all hope that the tribunal will be established with all possible speed. I urge the Minister to specify the start-up date in his reply, and recognise that there is an urgency to have evidence that the tribunal is functioning, and that such evidence be manifest at an early date. It is important that the weakest, most endangered and vulnerable people in these tragic events get answers to the issues of crucial public importance to be investigated by this tribunal.

We are living in a new era of openness and we recognise that makes demands on our administrative system, but they are demands that must be met. Dark secrets are being revealed to us, painful and important secrets. None have caused more suffering than secrets around the issue of viral infection of people with haemophilia. They need to know that each of our citizens has a right to know why circumstances occurred to cause a national catastrophe of the scale of infection we have seen and that we must never see again.

I support the resolution before the House. Few issues in Ireland in the recent past have given rise to such legitimate concern and disquiet among the public generally and among those unfortunate to have been touched by this tragedy than the infection of people with haemophilia with hepatitis C and HIV. We have a duty to ensure that a thorough and detailed investigation is carried out and that the results are made public. This is at the request not just of the Irish Haemophilia Society but of the public who are demanding that answers be given to people unfortunate enough to be infected in this way.

This inquiry has been established because people are entitled to expect that a State institution such as the Blood Transfusion Service Board is in a position to protect them, and that the Department of Health will protect them also. In this instance, people relied on the institutions of the State and they were let down. We need to know why and we need to ensure that something like this cannot recur.

This matter is a proper one for a tribunal of inquiry. I regret, however, that the only legislative path available to this House is the path provided by the Tribunals of Inquiry (Evidence) Act, 1921. Despite the many amendments made to this Act over the years, it is an inefficient, outdated and unsuited statute which is unable to permit an inquiry to be efficiently conducted. With hindsight, it would have been better for this House to have introduced a new modern statute setting out the powers of an inquiry. The 1921 Act was passed at a time when our Constitution was unwritten and when the legal concept of fair procedures as we now know it was wholly undeveloped.

The imposition of a constitutional superstructure on an antiquated Westminster statute has created a model for chaos which virtually guarantees friction between those being investigated and those conducting the inquiry. I hope such friction can be avoided in this instance and that this tribunal can avoid the mistakes made elsewhere.

The wholesale uncertainty as regards the scale and extent of the powers of a tribunal of inquiry, and the manner and circumstances in which these powers can be exercised, will cause difficulties for this tribunal. I hope it will be able to overcome those difficulties, but the absence of any coherent statutory guidance from the Oireachtas as to the extent of the powers a tribunal may exercise and the manner in which those powers may be exercised has resulted in virtually constant resort to the courts by persons involved with tribunals. To date, tribunals have not faired well in defending the powers they thought they had or the manner in which they have sought to exercise them. Each such excursion to the courts is a costly exercise to the taxpayers. The time has long since passed when this House should have introduced a modern statute, and I hope this will be the last tribunal established under the 1921 Act.

It should not be forgotten that a tribunal is set up to inquire into matters of definite public importance and to report to the Oireachtas to assist us in discharging our legislative task. We need to know what happened, and when and why it happened in order to take whatever legislative or administrative steps are necessary to ensure that this can never happen again.

The fact that the findings of the tribunal are of no legal consequence does not take from their importance. This tribunal is long overdue. I welcome the fact that the Irish Haemophilia Society is satisfied with the tribunal's terms of reference and that full consultation took place with the society before this motion was presented to the House. The IHS feels that the compensation to date has been inadequate in dealing with its claims and I look forward to the negotiations which will take place between the Department and the society to ensure that fair and equitable compensation is made available to sufferers.

The terms of the motion and the tribunal will investigate all those who had responsibility for this matter. In particular, it will examine the criteria, standards and procedures adopted by the BTSB concerning all matters, particularly donor selection, screening and testing, and the board's use of products manufactured abroad or in Ireland.

Accountability is the key word in investigating and establishing a tribunal. Everyone involved must be held to account. We need to know, as the terms of reference have established, when the information became available, when the various bodies received the relevant knowledge, and what action was taken, not only to reduce or minimise the risk of infection, but also to identify and notify those likely to have been infected. Reports that some time lapsed before these people were notified makes this case more sorrowful and horrific.

The fact that the House is asking the tribunal to investigate the role of the Minister, the Department and the National Drugs Advisory Board in carrying out their functions, shows that it is not afraid to investigate its affairs and those of people directly associated with it. Other institutions in the State might look at this example in light of recent events.

We are considering events which took place about 15 years ago and we have to accept that knowledge has grown, practices have changed and science and medicine have advanced. Therefore, it is particularly important that the tribunal's terms of reference stipulate that it must have regard to what existed at the time these events occurred. Whatever happens, the privacy and anonymity of the haemophiliacs and their families must be protected, if that is their desire.

The motion asks that the tribunal should be efficient and economical. I do not know if the word "economical" applies to any tribunals to date. However it goes about its work, I hope the tribunal's report, although of no legal consequence, will at least provide the information to the public; provide some consolation for the sufferers who have been waiting for answers for 15 years; and give guidance to those with responsibility for these areas so that we avoid future disasters involving the health and lives of the people of Ireland.

I thank Deputies Shatter, McManus and Hanafin for their contributions to this motion. It is important to note that the House is unanimous in the context of this motion and I am grateful to the Deputies for their support. The motion meets the requirements, in so far as we can gauge them, of those who have made inquiries about these matters and who are satisfied and supportive of the approach being adopted by the Government.

Since becoming Minister, I have been particularly mindful to ensure that we have a full process of consultation and periods of reflection on the issues raised in seeking to produce terms of reference which are workable and which meet the objectives of those concerned. Given the public interest requirement concerning disclosure of facts, it is important that we successfully address these issues and do not end up with a situation in which the tribunal cannot report because of its terms of reference. This must be understood when reflecting on the time given to this issue.

In January 1997 the previous Government indicated that it agreed in principle with setting up a tribunal of inquiry. The Finlay tribunal was still sitting at that time and was the focus of attention. Therefore, virtually no work was done on this matter until the change of Government in July 1997.

I met the Irish Haemophilia Society in September for the purpose of beginning a process which has taken 18 months to come before the House. The previous Government did not give a commitment to address the separate issue of fair and equitable compensation. It is important to point out that, at a meeting on 23 February 1999, the Government noted the Irish Haemophilia Society's concerns in relation to its perception of the inadequacy of the compensation available for persons with haemophilia infected with HIV or hepatitis C; affirmed its commitment to fair and equitable compensation for such persons; and asked me, following detailed discussions with the society, to revert to Government with proposals to address any inadequacy in the current compensation arrangements in a fair and equitable manner. This is a separate matter which those involved wish to see dealt with separately. For that reason we will be in a position to proceed with discussions on that matter following the adoption of this motion by the Oireachtas and the setting up of the tribunal into the substantive issues of concern to them.

The IHS submitted a number of documents detailing its views on the compensation issue, including its views on perceived anomalies in the present hepatitis C compensation tribunal as it applies to persons with haemophilia who are co-infected with hepatitis C and HIV. At a meeting with the society on 21 May 1999 I agreed that, when this motion had been passed by both Houses of the Oireachtas, discussions relating to compensation would commence between the society and the Department. That is an agreed position between us on that separate matter.

As regards recent events there has been a perception that there was delay or a spurt of activity at the last moment. As I stated publicly at the time, we had reached a situation where 95 per cent of the work had been completed. There was one issue to be addressed and the most up to date draft terms of reference had been communicated to the IHS. I did not believe then and I do not believe now that there was reticence on the part of the Department or the Government to deal with this matter. When we received the final draft from the draftsman, which people were told would be produced the following week, we were able to arrange a meeting on the Friday morning between the Attorney General, myself, Department officials and the IHS to go through the issues in some detail. That confirms that work was very much advanced and that we were at the final stages of coming forward with the motion which is now before the House. This must be said to address the perception or presentation that suddenly everything was done in a week. That was not the case.

The complexity of the issues involved, particularly the jurisdictional issue of setting up a tribunal to investigate matters that occurred outside the State, was recognised by Members who contributed to this debate. Anybody with a cursory knowledge of the law would know that there were complex legal matters involved in arranging to meet the objectives of victims, as I have always sought to do, who wanted an international dimension to the inquiry. There was a requirement for people to get independent advice and, if they wished, to make their own inquiries in those jurisdictions as to how we might be able to secure the maximum possible amount of information which could be considered by the tribunal.

Since coming into office, our work on that specific issue has been conducted by working openly with the people concerned. Counsel for the State, counsel for the Department and counsel for the society met on a number of occasions to discuss these issues at length. It should be emphasised that there was an open, co-operative process involved in ensuring everybody understood the situation, the essence of the issues which had to be addressed, the fact that they could not be fudged and that there was an obligation to arrive at a workable solution.

Given the public statements by the Irish Haemophilia Society, I believe it is supportive of these terms of reference as the best possible formula to provide for a workable, timely and efficient tribunal to address these issues as speedily as possible. I am grateful to everybody in the Department and in the Office of Attorney General, to the Attorney General himself and to the people I have met in relation to this issue for the work they have done, their constructive approach and their bona fides in trying to arrive at a solution that meets the requirements of the case.

Deputy Shatter inquired about the timescale. I expect public hearings of the tribunal to commence in the autumn. However, I hope that when the chairperson is nominated by Government, he or she will be able to begin reading into the brief, assembling a legal team and contacting relevant bodies and persons. I hope as much preparatory work as possible is completed during the summer and early autumn so public hearings can commence in the autumn. I am currently involved in discussions with the Attorney General with regard to the selection of a suitable person to chair the tribunal. Subject to Government approval, I hope to announce the name of the chairperson at an early date.

Deputy Shatter raised the issue of contacts with pharmaceutical companies. Some inquiries would have been made of the Department but, obviously, until terms of reference were agreed and the parameters of what would be involved could be completed, there was a need to ensure we did not, in any sense, compromise or create a perception of compromising ourselves or our position. One must also be mindful of the fact that civil actions are being taken by individuals against the same companies. It was important, therefore, that the Department was seen to act in a way in which nobody could suggest the public interest was being compromised or that there was negotiation taking place with people who will have to come before the tribunal or with people whose representatives reside in this State. Whatever action the tribunal chairperson may take to trigger the international dimension as set out in the terms of reference will be a matter for the tribunal chairperson in due course.

I was extremely anxious to maintain the integrity of our position in terms of the Department pursuing the formulation of terms of reference which were objectively required to meet the circumstances of the case. For that reason, I was not involved in discussions with pharmaceutical companies on the issue, although they indicated what their concerns might be in written correspondence from legal representatives to the Department. However, no work has been done by the Department with the pharmaceutical companies. That can now take place under the aegis of the tribunal with the terms of reference established.

That was the more prudent way to proceed to avoid misconception or misrepresentation of anybody's position, although I acknowledge the argument put forward by the Deputy is made in a helpful and constructive manner. In all the circumstances of this case, however, it would not be a prudent course to adopt. It should now be left to the tribunal chairperson and his or her team to pursue it.

Carlow-Kilkenny): The Minister is allowed only ten minutes and he has now used 12.

It is an important issue and I am anxious to address all the concerns raised.

Acting Chairman

Is that agreeable to the House? Agreed.

Deputy Shatter also raised the matter of medical assessors in terms of their being of assistance to the chairperson, given that extremely technical issues are involved. While this is primarily a matter for the tribunal, there can be considerable advantages in the tribunal having access to one or more medical expert to assist in its work. This is a matter I intend to discuss with the chairperson in due course in the context of the modus operandi of the tribunal.

As I said previously, there has been limited contact between the Department and solicitors acting for one of the pharmaceutical companies. However, these contacts related to requests from the company for advance information on the terms of reference rather than the matters raised by Deputy Shatter. It would not have been possible for the Department to enter into consultations with the companies until the terms of reference had been settled and, in particular, the extent to which the companies would be investigated became clear. It is only within the past two weeks or so that the position in relation to the terms of reference and the role of the companies has been clarified. Given that the tribunal is about to be appointed, it would be more appropriate for the tribunal itself to deal with the companies rather than the Department getting involved in the process.

Deputy Shatter raised the issue of establishing a new criminal offence where public bodies, or persons working on behalf of public bodies or authorised to work on their behalf, act in a way that is reckless and, on the evidence, criminal. I listened to his argument for the need to strengthen criminal law in relation to negligent acts by public bodies and their staff, but the Deputy will appreciate that it is a broader issue which will impact on all public services, not just the health services. I understand the Law Reform Commission has given preliminary consideration to the matter in one of its recent reports. It can be followed up by the Minister for Justice, Equality and Law Reform with regard to the overall policy issues it raises.

Deputy McManus raised the question of the availability of documentation from the Department for the society. That documentation is being assembled in preparation for the tribunal and we have no problem with what is, effectively, a voluntary discovery process to allow the IHS or its representatives look at any documentation which will be forwarded to the tribunal in due course. The BTSB has granted solicitors for the IHS substantial access to its files and documentation over the past few months. I understand there was a reluctance on the part of the BTSB to allow copies of documents to be removed from the offices of its solicitors until the terms of reference were known. Now that the terms of reference are available, I hope the IHS and the BTSB can reach agreement on that matter. The Department has given a commitment to facilitate inspection by the IHS solicitors as soon as the material has been catalogued.

Deputy McManus raised the recent High Court hepatitis C appeal case in which an award of £150,000 in general damages by the tribunal was increased to £250,000. Media comment at the time indicated that the tribunal had been operating a cap of £150,000 for general damages. Since the judgment, my Department has been informed by the tribunal that it did not operate such a cap and that it had made awards of up to £250,000 in general damages in other cases where it felt that was warranted. I do not expect the High Court judgment to have implications for all the cases dealt with by the tribunal, and I understand senior counsel for Positive Action takes a similar view.

Will that court decision be appealed by the State?

No. Deputy Hanafin's interesting contribution raised the fundamental issue of the need for a more modern framework other than the Tribunals of Inquiry (Evidence) Act, 1921, to deal with matters of public importance. That is a salient point with which I believe the public would agree. One issue is fair procedures, which is a considerable legal issue in the context of drafting terms of reference to allow matters under inquiry to be efficaciously and comprehensively addressed. We usually seek to establish tribunals where they relate to matters of public importance which have wide ramifications. Given the build up of constitutional and administrative law, it is an issue which needs to be addressed as a policy matter because we do not want a situation where the investigation of matters of public importance, where it is warranted, gets a bad name because of what are seen to be lengthy and distracting appeals to the courts which, while it is the entitlement of any citizen to take them, as far as the public is concerned, are seen to draw out the issues under investigation by a tribunal.

It is a fair point to make that the 1921 Act is a creature of the Westminster Parliament and predates the constitutional superstructure imposed under the 1922 and 1937 Constitutions. That it was enacted when we did not have a written Constitution means we should not be surprised that problems arise. There is a need for a modern statutory framework where it is deemed to be in the national interest to have tribunals to examine matters of public importance. Given the level of State and public involvement in national affairs and the sophistication of national life compared to 70 or 80 years ago, a fair point can be made that that review should be undertaken in policy terms.

I thank Deputies. It is my objective that Members, in recognition of the issues which must be addressed, would be united in addressing these matters of public importance in an uncontentious way while at the same time ensuring proper issues are raised for which we would be accountable and which we would have to explain. I am glad it is in that atmosphere we have been able to approach these issues, mindful of the victims and their families, the fact that these people have a difficult clinical condition, that they want to see these issues addressed comprehensively and as quickly as possible and that they want to see the Dáil, the Seanad and the tribunal, when established, handling them in a sensitive and comprehensive manner.

Deputy McManus referred to the need to address the issues aggressively. What is important is that the issues be addressed comprehensively and in a manner which respects fair procedures and ensures the terms of reference we adopt allow us to get to the root of the issues and obtain as much knowledge and explanation of the context in which decisions were taken and where responsibility lies. To that end, chairpersons of calibre are available to us through the judicial process and the Judiciary generally who can forensically examine these matters and report to us in a comprehensible and explicable fashion.

The immediate issue is to finalise discussions with the Attorney General on the appointment of a chairperson. We will seek a person who will meet everyone's approval as a person of experience and someone with the competence to deal with these issues. A number of likely candidates are available to us. The discussions must be completed before we can make an announcement, but I intend to complete them as quickly as possible. I thank Deputies for their contributions.

Question put and agreed to.
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