Limerick East): Before I deal with the terms of the motion I feel it incumbent on me to make a number of points of relevance. First, I know that I speak for everybody in this House and throughout the country, regardless of political affiliation, when I say that it is almost impossible to come to terms with the enormity of the scandal surrounding the hepatitis C infection of the anti-D product and the blood supply. Notwithstanding our best efforts to do so, I believe it will take a considerable length of time for all of us to comprehend fully the horrendous effect which this scandal has had, and continues to have, on the health and everyday lives of innocent victims and their families.
I truly believe that no words of mine, or indeed of any previous holder of the office of Minister for Health, can ever adequately apologise to the 1,600 women and men for the damage done to them by a system in which they had previously placed their fullest trust and confidence. Trauma and fear have been engendered in many innocent people by this experience. Yes, there is some recompense in the recognition that grievous wrongs were committed. Yes, there is some recompense too in the unequivocal allocation of responsibility for these wrongs by the tribunal of inquiry. There is some minor recompense also in the monetary awards to the affected victims — awards which we can only hope alleviate the suffering and distress expressed so heartrendingly by the victims and their immediate families. However, nothing can ever fully or irrevocably compensate them for being infected with hepatitis C — a condition for which, as yet unfortunately, there is no cure.
The formidable task of disentangling the complex facts of this tragedy, of putting order on them and setting them out plainly in language which precisely and exactly conveys the awfulness of these events, was entrusted by the Houses of the Oireachtas to Mr. Justice Finlay and has been discharged by him with unprecedented efficiency and expedition, for which I wish to record my thanks, the thanks of the Government, and, I am sure, of this House. The result of the House's decision to establish the tribunal is that there is now available for all who wish to avail of it — victims, participants, politicians, doctors and the public — a clear and coherent account of this matter, who is responsible and what is now to be done. The truth has been laid bare, a number of recurrent controversies laid to rest and responsibility allocated in a fair, just and impartial manner. It does not make happy reading.
No citizen, be he or she victim or participant in the events described or a mere concerned observer, can fail to be moved and humbled by the account of the distress and fortitude of those who have suffered and continue to suffer from the events described. The report gives us a coherent account of what occurred and why, but it is considerably more than merely a history. It is an unemotional indictment of past procedures at the BTSB and is unequivocal in its apportionment of blame to certain named members of staff. It offers a welcome and succinct illumination on a number of difficult legal issues — for example, the application of the Therapeutic Substances Act, 1932.
However, it also looks to the future. From the victim's point of view it sets out the factual basis upon which their claims for compensation, either in court or before the tribunal, will henceforth be based. The State will not seek to repudiate or resile from any of the tribunal's findings in any such forum. From the point of view of the blood supply it sets out a number of important recommendations, all of which have been accepted in full. The exceptional command of the facts exhibited by Mr. Justice Finlay lends to his recommendations an authority and a widespread acceptance that ensures the implementation of his recommendations in full will provide a sound basis for restoring full confidence in the blood supply.
I cannot allow this opportunity to pass, however, without commenting on the most recent incident involving the BTSB, namely, the contacting of an infected victim with a view to obtaining blood. Mistakes such as these, even when there is no risk to the blood supply, are simply unacceptable. I have made my views known trenchantly to the chairman and chief executive of the BTSB; and while I accept that great strides have been made in reforming the operations of the BTSB, it must be fully recognised that this latest incident has added to the negative perception of that organisation which the current management has done so much to dispel. Notwithstanding the real difficulty people may have in coming to terms with what has happened, the truth is that we need blood, our hospitals need blood and it is grossly irresponsible to call for the closing down of the BTSB or for the sacking of a public servant who has devoted such an enormous amount of time, effort and dedication to resolving the problems of the BTSB. Undoubtedly, mistakes can occur; but I will not be satisfied until such time as we can with total confidence rule out even the most minor error, because each such error, no matter how small, can undermine confidence in the BTSB.
Huge strides have been made to improve standards at the BTSB. The work of Mr. Liam Dunbar and Professor Shaun McCann has been invaluable in reorganising the BTSB and in setting and implementing new standards and procedures which ensure that the mistakes of the past will not recur. Management has drawn heavily on the recommendations of the Bain consultancy report in forming a strategic plan, much of which is already implemented. The acceptance of recommendations in Mr. Justice Finlay's report will further improve standards at the BTSB.
I would like to deal with these recommendations in some detail because they are important for the future. I have already stated publicly that the Government accepts in full the recommendations of the report. These recommendations will be implemented as quickly as possible. The report makes six significant recommendations in relation to the future workings of the BTSB and the Irish Medicines Board. Those portions of the development plan for the BTSB for the period 1996-99 which have not yet been implemented will be implemented without delay. I will ensure that the 1999 target date for completion will be met. In particular, I have approved the relocation of the art headquarters of the BTSB from Pelican House to a new site on the campus of St. James's Hospital. This new building will ensure that state of the art laboratories, including all the necessary equipment and staff, can be put in place to ensure that our national blood service will have the required range of facilities to carry it through to the 21st century. The renewal or replacement of the BTSB unit in Cork will be commenced immediately. The estimated capital cost for the completion of the development plan is £20m.
The tribunal has made detailed recommendations in relation to the monitoring of the BTSB by the Irish Medicines Board. In response to the expert group report of April 1995, I have given the Irish Medicines Board statutory responsibility for the inspection of the collection, screening, processing and quality control facilities and procedures in respect of blood, blood products and plasma derivatives with a view to ensuring their safety and quality. The tribunal has recommended that the Irish Medicines Board should carry out at least two full inspections of the BTSB each year. This has already been implemented in that the arrangement is that the IMB carries out four inspections of the BTSB each year. My Department has commenced discussions with the Irish Medicines Board with a view to implementing a recommendation that it should be required to make an annual report to the Minister, for publication, on the outcome of these inspections and also on any reports received by the IMB of abnormal reactions to blood or blood products from any person or institution.
The tribunal has recommended that there should be a statutory obligation on medical and nursing personnel to report contemporaneously all abnormal reactions to blood or blood products both to the IMB and the BTSB and that the BTSB should also be obliged to report to the IMB on all abnormal reactions of which it becomes aware. The tribunal also recommends that failure by any employee of the BTSB to report such abnormal reaction if committed intentionally or by gross negligence should be a criminal offence. I am accepting this recommendation. There are potentially difficult legal issues which will have to be teased out in the course of its implementation and I have already instructed my Department to proceed immediately with this work.
A blood service consumers council, including representation from those who regularly receive blood and those who regularly donate blood, will be set up in the immediate future. This will make a major contribution to the maintenance of public confidence in the supply of blood and blood products. I believe it is vital that members of the general public should have an advisory role in the BTSB.
The report of the tribunal is critical of the recall of the anti-D product undertaken by the BTSB in 1994 and has recommended that the BTSB should forthwith prepare a new standard operating procedure for a recall of any product, the safety of which is suspected. I have instructed my Department to commence the process of implementing this recommendation with the BTSB.
The tribunal has also looked at the difficulty which could arise if it was again necessary to stop using a particular blood product at short notice but there was no product authorisation in place for alternatives which could be imported quickly as an emergency replacement. The tribunal points out that a commercial undertaking may not be concerned to undergo the trouble or expense to obtain a product authorisation on the off chance that its supplies may be needed in an emergency. The tribunal has asked that a possible solution should be considered whereby the present regulations would be amended to provide for what it terms "standby" or "emergency" product authorisations to cover such situations. This is a most worthwhile suggestion which I have instructed my Department to investigate without delay. I accept the tribunal's recommendation that if such a scheme is feasible the BTSB should be required to make use of it so that "standby" authorisations will be in place for products such as anti-D and factor VIII.
The implementation of the tribunal's recommendations will build on the work already undertaken by the new management in the BTSB to ensure as far as possible the safety of blood and blood products into the future. The necessary groundwork has already been put in place by the new management of the BTSB over the past two years in respect of many of these matters.
Hundreds and thousands of people in this country have given freely over decades millions of donations of their blood in order to maintain, sustain and extend life for those critically ill or critically injured. Our blood supply system in this country is among a small handful of unique voluntary blood supply systems. I appeal to people on all sides of this House to approach the current debate on how best to protect and promote the integrity of the national blood supply with humility, with a sense of proportion and balance and with a real sense of responsibility for a public duty in its broadest meaning. In the interest of the nation Members on all sides of this House, while exercising their absolute right to scrutinise all Government policy at all times, will accept that the voluntary blood supply is a national asset which should not be unfairly exposed to partisan politics, whatever about particular criticisms.
I met recently with representatives of Positive Action in response to a letter which they sent to me on 14 March last outlining their views arising from the publication of the tribunal report. Positive Action has requested a full reappraisal of the compensation tribunal. The reappraisal upon which the Government is embarking is principally required because our knowledge has been altered by the publication of this report.
The Government has decided to place the compensation scheme on a statutory basis, but has resolved that the operation of the compensation tribunal should not be disrupted or delayed while the scheme is being prepared and the statute drafted and enacted. This will take some time and in the meantime I am determined that the operation of the compensation tribunal will not be disrupted or delayed. It will continue to operate as normal under the direction of Mr. Justice Egan so that people who have already applied for a hearing will get that hearing as arranged. I will seek to ensure that everyone who has either gone through the tribunal, is currently before the tribunal or will be before the tribunal in the near future will retrospectively benefit from any changes made. It is also my intention that the terms of the compensation scheme should provide for an appeal to the High Court on the amount of awards made by the compensation tribunal.
Considerable attention has been given to the prohibition in the existing terms of reference of an award of aggravated or punitive damages. It has been pointed out that the option of awarding such damages is available to the High Court but not to the tribunal and that it would be preferable if it had the same freedom as the High Court in this regard. Accordingly, I will be proposing that this restrictive provision be removed from the terms of reference of the tribunal so that it will be free to award damages on exactly the same basis as the High Court. It will be for the tribunal to decide whether such damages are appropriate and how they should be measured if that question arises. In considering that question the compensation tribunal will be informed that the Government accepts the findings of the tribunal of inquiry and that the report's findings of fact should be accepted by the compensation tribunal.
Last Thursday I indicated the Government's intention to reappraise and amend the terms of reference of the compensation scheme following consultation with representative groups and the chairman of the compensation tribunal. I am hopeful that this consultation process can commence with the groups at an early date. I have also asked the BTSB to forthwith make known its position on liability on all outstanding cases in the light of the report's findings.
Regarding the National Drugs Advisory Board, the tribunal concluded that: "In the period 1975 to 1994, successive Minister for Health and the Department of Health failed adequately and appropriately to supervise the NDAB in the exercise of its functions concerning the licensing of the manufacture of products by the BTSB and the authorisation of products by the BTSB, in that they failed to provide to the NDAB the appropriate resources for carrying out those functions".
The tribunal found that the levels of staff, particularly on the technical side including inspectors, was inadequate. Consequently, the NDAB did not carry out regular and adequate inspections of the BTSB. While the tribunal found that such inspections would not have revealed the particular batches which gave rise to the infection of anti-D except by some form of chance, it states that:
If those resources had been provided and if there had been appropriate inspections and investigations, it is possible that the reactions of the recipients of anti-D in the period 1976 and 1977 to the contaminated product, would have been revealed and that the persons involved in the BTSB would have made further investigations than they did if they were aware of the likelihood of further inspection and interrogation.
The position now is very different as a result of the steps which I have taken in the last two years. The NDAB has been replaced by the Irish Medicines Board, on foot of the Irish Medicines Board Act, 1995. All statutory licensing functions previously held by the Minister for Health have been transferred to it to eliminate the unnecessary additional layer of administrative process which contributed to the backlogs in the licensing system in the past.
A major management consultancy exercise was commissioned in 1995 to identify the staffing, systems and operational procedures which the new board would require to carry out its functions properly and the previous organisation has been restructured in line with the recommendations which emerged. In particular, the licensing fees charged to the industry have been set at a more appropriate level to ensure that the board has adequate resources to carry out its functions thoroughly, efficiently and without undue delay. The organisation is now driven by a streamlined board with a management rather than a technical orientation. It has also been relocated in new premises as those used by the NDAB were inadequate and a hindrance to increasing the efficiency of the organisation.
Since coming into office I have addressed and resolved the organisational and resourcing problems which the tribunal found to have beset the NDAB for the previous 20 years.
I now wish to turn to the supervision of the BTSB by the Department of Health since February 1994. Chapter 13 of the report of the tribunal deals with my response and that of my Department and the response of my predecessor, Deputy Howlin to the hepatitis C issue. This response included the establishment of many programmes and schemes to support the victims of this terrible tragedy and to alleviate as far as possible the human suffering occasioned by the hepatitis C infection of the anti-D product and the blood supply.
I wish to briefly outline the various programmes and schemes and the findings of the tribunal in relation to these. A national blood screening programme was announced by my predecessor, Deputy Howlin, on 21 February 1994 to screen all women who received the anti-D product in order to identify those who were infected with hepatitis C. For persons who were diagnosed positive for hepatitis C under the screening programme, acute hospital services were put in place in special units in six designated hospitals, namely, Beaumont, the Mater, St Vincent's and St James's in Dublin, Cork University Hospital and University Hospital, Galway. These services, provided under the Health Act, 1970, are free of charge and include access to both inpatient and out-patient treatment as required. Special funding has been and will continue to be provided by the Department of Health for these services. For example, in 1996 a special sum of £2 million was provided and a similar sum will be allocated for 1997. The Tribunal of Inquiry concluded that: "The overall picture appears to be that treatment as far as treatment has been developed by the medical profession in general for this unfortunate disease was adequately provided in these units". The special secondary healthcare services are included in the healthcare package agreed with the groups representing persons with hepatitis C.
The Tribunal of Inquiry stated that the ex-gratia expenses scheme apparently worked “reasonably satisfactorily”. It concluded that it was satisfied that the decision of the then Minister for Health, Deputy Howlin, to set up an expert group was “an adequate and appropriate response to the problem of trying to find out what actually happened in regard to this infection of anti-D”.
It has been widely alleged that I engaged in a cover-up by failing to immediately set up a tribunal of inquiry in March 1996 when laboratory test request forms or quantitation reports indicating the clinical diagnosis of infective hepatitis discovered by the BTSB in the action being brought against them by the late Mrs. Brigid McCole became public. Both I and the Minister of State, Deputy O'Shea, informed the Dáil that these test request forms did not constitute any fundamental difference in the information available with regard to the wrongful use of patient X's plasma. It was claimed by some Senators that these quantitation reports were of fundamental importance and altered the entire situation concerning the events of 1976 and 1977.
The tribunal concluded that the quantitation information did "not constitute new, dominant or fundamental medical evidence" and did "not form a foundation for any particular conclusion which would not have been reached without them to the general wrong doing in the use of the plasma from patient X". It further concludes that my decision not to set up a tribunal of inquiry at that time "was an adequate and appropriate reaction to the facts as they then were".
In addition, the tribunal indicated that "the attitude taken by [myself] and Minister O'Shea, in reply to the Dáil questions in relation to this issue would appear to have been correct". In all fairness, I would ask those Members of both Houses who laid those charges against me and the Minister of State, Deputy O'Shea to come forward and withdraw the charges.
The tribunal concluded that from the evidence of the communications between the Department and the BTSB with regard to the targeted look-back programme that, at all relevant times, it would appear to indicate an adequate and appropriate reaction.
I announced, on 12 September 1995, the national optional testing programme. This programme was introduced to ensure that all recipients of blood transfusions and blood products, who might have become infected with hepatitis C through the receipt of transfusions or blood products, were given the option of being tested free of charge.
The health care package agreed with the representative groups includes primary healthcare services as provided for in the Health (Amendment) Act 1996.
In respect of the health care package, the tribunal concludes that: "on balance the position would appear to the Tribunal to be that the Health Care Package, when finally provided, was appropriate and that it was, when provided, adequate but that some element, although not a great one, in the delay in bringing such a package into statutory from, was not an adequate response to the particular urgency which attached to that task".
In relation to this conclusion, I would like to outline the timing of the various stages of the passage of the Bill in both Houses of the Oireachtas and the consultation and arrangements which took place for its implementation.
In November 1995 negotiations took place with Positive Action on the health care services and on 4 December 1995 the Government authorised the drafting of the Health (Amendment) Bill, 1995. On 11 December 1995, I sought Government approval for the text of the Bill and on the 12 December 1995 the Government approved its publication. The Second Stage debate on the Bill took place in the Dáil after the Christmas recess on 27 and 28 February 1996. During March and April, further negotiations with Positive Action and other representative groups on the amendments to the Bill took place. On 8 May 1996 the Committee Stage debate took place in the Select Committee on Social Affairs and Report and Final Stages were taken in the Dáil on 30 May 1996.
The Second Stage debate in this House took place on 13 June 1996 and the Committee and Final Stages were taken in this House on 20 June 1996. In July and August 1996 negotiations, including negotiations regarding fees, took place with professional organisations, particularly with GPs, and health boards on the implementation of the provisions of the Act. Consultations with the representative groups on the design of application form, health cards and arrangements for service delivery followed and on the 28 August 1996 I signed the commencement order bringing the Act into effect on 23 September 1996.
On 17 December 1996 I announced my intention to establish an optional HIV testing programme offering screening to blood transfusion and blood product recipients who may be at risk, however small that risk might be. Before commencing this programme, it is absolutely essential that the risk, if any, involved for recipients, according to the year that they received the transfusion or blood product and depending on the risk, if any, of particular products, must be determined, as far as possible so as to enable each recipient to make a fully informed decision, in consultation with his/her general practitioner in relation to availing of screening. I am hopeful, that the preparations for the optional HIV screening programme, which are well advanced, will be completed in the coming weeks. In the meantime, the HIV targeted lookback is continuing.
On the 28 January 1997 I announced the Government's intention to establish a tribunal of inquiry to examine specific urgent matters of public importance; (a) the HIV infection of blood and blood products manufactured and distributed by the BTSB, and (b) such further matters in respect of blood and blood products as may require investigation in the light of the report of the hepatitis C tribunal.
I stated that it would not be possible to submit the terms of reference to both Houses of the Oireachtas for approval until the report of the tribunal of inquiry had been submitted to me as it would not be possible to say what matters of urgent public importance would remain unaddressed. As Members are aware, the report was submitted to me on 6 March 1997 and the detailed terms of reference will be finalised, in consultation with the Irish Haemophilia Society, at an early date. The success of the hepatitis C Tribunal of Inquiry can, in part, be ascribed to its very specific terms of reference. Accordingly, great care will be taken to ensure that the terms of reference of this proposed tribunal will be very tightly framed to address specific issues.
As Members of the House know, the Government has agreed, at my request, to refer the report of the tribunal of inquiry to the DPP. This issue was argued before the tribunal of inquiry and the tribunal considered that it would not be appropriate for the tribunal to make such a referral. However, because of the enormity of the tragedy and the contents of the report, I have, with the authority of the Government, referred the report to the DPP.
All parties in this House, who have served in Government, must bear some responsibility for the events which have occurred. The tribunal comments adversely on the failure of successive Ministers for Health to adequately fund the NDAB between 1975 and 1994.
I am aware that no member of the Progressive Democrats has held office as Minister for Health. The Progressive Democrats, however, were in Government between 1989 and 1992, when some of the most shocking events occurred; the lack of action when the Middlesex letter clearly informed the BTSB that patient X had suffered from hepatitis C and the use of patient Y's plasma when she had tested positive are examples of this. They must also bear collective Cabinet responsibility for the inadequate funding of the NDAB during their period in office. They should also recall that two of their leading members were Cabinet Members in Fianna Fáil Governments from 1977 to 1981 when the original infection was occurring and spreading through many unsuspecting women. Spokespersons for the Opposition should remember this before they launch political attacks.
I welcome and invite contributions from all sides of the House regarding the management and delivery of the blood supply service. What I do not welcome are unfounded or ill-advised headline seeking or sweeping statements about matters requiring clear medical direction or medical expertise.
A number of persons asked why the conduct of the McCole case was not a matter into which the tribunal inquired. A tribunal of inquiry such as this is set up by the Houses of the Oireachtas. Our Constitution guarantees the separation of powers between the Houses of the Oireachtas and the courts. Consequently, it is not constitutionally possible for the Houses of the Oireachtas to initiate an inquiry into how a case was conducted before the courts. The Government has strong legal advice that the Oireachtas cannot attempt to deal with the issue of how a court case is handled or to make findings on the way it is handled. Any such issue is a matter for the courts themselves.
Once again the issue of the conduct of the McCole case has been raised. The position is as I have explained it on a number of occasions previously and as was explained by the Taoiseach on the order of business in the Dáil this morning. There were three defendants in the case in question: the Blood Transfusion Service Board, the National Drugs Advisory Board and the State. As far as the BTSB and the NDAB are concerned, they had separates boards, separate legal teams and separate insurance in regard to liability and pursued their own independent legal decisions and strategy on the basis of their advice and authority. State boards of all kinds daily take decisions on legal cases being taken against them which are not the subject of direction, authorisation or decision by Government. It would be impossible for the State board system to function in any useful way if the decisions about acceptance or otherwise of liability by a State board were to be referred to the Cabinet for decision. They were not referred to the Cabinet for decision in this matter.
As far as the State defence is concerned, the Government did receive formal legal advice that the State, as distinct from the BTSB, did not have a liability in this matter. That is obviously legal advice which, when received by any Government it must take due account of, particularly from the point of view of accountability for public funds. It is not possible for the Government to ignore legal advice about liability in regard to taxpayers' funds. When the advice was given as to the State's liability in this matter, that advice had to be taken seriously, as it was, in any discussions we had on this matter.
I hope Members will appreciate and understand, however, that the Government's priority was to set up a non-adversarial system for the quickest dispensement of compensation to the victims. We did not want to get involved, as a priority, in legal cases in an adversarial setting but rather to ensure, through the establishment of a non-adversarial tribunal for compensation, that compensation would be paid to the women as quickly as possible and, subsequently, to the other victims, both men and women. That was our priority. This problem existed for some time but the Government establishment of a tribunal of compensation ensured, without the requirement of being engaged in adversarial faultfinding, that there would be quick compensation for the victims. The issue of fault and liability is a separate matter. Our first priority was to ensure there would be a speedy and effective way of compensating the victims as their concerns come first.
I know that many Senators are anxious to contribute to this debate and that they will have many questions and comments about the report of the tribunal of inquiry and the BTSB. I welcome such comments and I will endeavour to answer the questions when I conclude this debate this afternoon.
