,Limerick East): I propose to take Questions Nos. 3, 5, 13 and 26 together.
The matters which form the substance of these questions are the subject of a number of cases which are currently before the High Court and I, as Minister for Health, am one of the defendants. I understand that on Friday last the President of the High Court fixed 8 October as the commencement date for the hearing of one of these cases.
The Dáil is not a court of law and it would be inappropriate for it to encroach on the functions of the courts or the Judiciary. As one of the defendants in these legal actions I am particularly constrained in what I can say to the House. The legal rights of the plaintiff and the defendants in any legal action must be respected and there is an onus on me and all Members of the House to avoid comment which might prejudice the outcome of the proceedings.
I wish to refute the allegations that my colleague, Deputy O'Shea, Minister of State at the Department of Health, misled the Dáil in responding to a Dáil adjournment debate on 28 March 1996. In my press statement of 17 April 1996, I reiterated that there was no contradiction between his statement to the Dáil and the report of the expert group on the Blood Transfusion Service Board. I confirm that there is no such contradiction.
There is a degree of confusion and misunderstanding in relation to the terms "infective hepatitis" and "jaundice". On 25 February 1994 the Blood Transfusion Service Board informed the Department of Health in writing that the board had
...been informed that the patient had an episode of jaundice early in the course of her treatment which led to an initial investigation of her hepatitis B status.
The fact that this was the first time that my Department had been informed that a donor to the plasma pool used for the manufacture of the anti-D product had had an episode of jaundice was one of the principal reasons a decision was made by the then Minister for Health to establish on 4 March 1994 an expert group with the following terms of reference:
(I) To examine and report to the Minister for Health on the following matters:
(a) all the circumstances surrounding the infection of the anti-D immunoglobulin product manufactured by the Blood Transfusion Service Board.
(b) the systems and standards in place for donor selection, the manufacturing process and use of the anti-D immunoglobulin produced by the Blood Transfusion Service Board.
(II) To make recommendations to the Minister for Health on the above matters and any other matters relating to the Blood Transfusion Service Board which the group consider necessary.
The report of the expert group was published by the Government on 5 April 1995.
As I have stated, one of the principal reasons for establishing the expert group was the information given by the BTSB to the Department of Health in a letter of 25 February 1994.
I have been informed that, at the time of the establishment of the expert group, that the Department of Health, the then Minister for Health and the members of the expert group were in no doubt that the donor to the plasma pool for the anti-D product had an episode of infective hepatitis. If the donor's episode of jaundice was not related to infectious causes i.e. not infective hepatitis, it may not have been necessary for the expert group to consider this matter. Blood donors with a history of jaundice not related to infectious causes could be accepted as donors. However, it must be pointed out that the diagnosis of the patient as "infective hepatitis" in November 1976 was a clinical diagnosis, i.e. an observational diagnosis. Following this clinical diagnosis of infective hepatitis, the BTSB sent samples of the donor's plasma to the UCD virology department and Middlesex Hospital, London for laboratory tests. At the time, 1976-77, there was no routine test available for hepatitis A. A routine test for hepatitis A was introduced in the virus reference laboratory at UCD in March 1981. The hepatitis C virus was not described until 1989 and routine testing for hepatitis C was introduced by the BTSB in October 1991 when a scientifically reliable test was available.
The donor's plasma tested negative for hepatitis B in both laboratories. Therefore, the clinical diagnosis of infective hepatitis was not confirmed by the laboratory tests. However, while the BTSB, stopped using the donor's plasma following the clinical diagnosis of infective hepatitis, the board decided to resume using her plasma having apparently concluded that the jaundice/hepatitis was due to environmental factors. I have been advised that the term "jaundice related to environmental factors" would generally be interpreted as meaning that the jaundice was caused, not by a blood borne virus, but rather by one of a number of factors such as poor hygiene or consumption of contaminated food or drink.
The expert group at paragraph 6.11 in its report concluded as follows:
In 1977, the BTSB had clear standards governing the selection of donors for (a) ordinary blood donors and (b) the male donor panel for anti-D production. In both categories, the BTSB's standards prohibited the use of donors with a history of infectious hepatitis or jaundice of unknown origin. We consider that the BTSB should have applied those same standards to the 1976/77 female plasma exchange patient. Her plasma would not have been accepted under the standards set down for the other categories of donor, and should not, we believe, have been used in the production of anti-D in 1976/77 after she had become jaundiced.
The expert group on the BTSB carried out its work by meeting relevant individuals and groups and by requesting relevant documentation. It requested meetings with interested parties and, in a small number of instances, individuals approached the group for a meeting. In addition, it wrote on a number of occasions to the then chief medical consultant and the then chief executive officer of the BTSB for information on specific issues. Where additional queries arose, the group invited individuals for further discussions. The expert group did not seek each and every document in the BTSB. It held its meetings and examined documentation between March 1994 and early January 1995.
As I have already stated, High Court proceedings have been initiated against the BTSB and others. The file referred to by the Deputies is a BTSB internal file which was disclosed to the plaintiff by the BTSB in accordance with a High Court order. The BTSB at no time forwarded any internal file to the Department of Health. I would like to state unequivocally that there are no BTSB files in my Department.
I understand, however, that attached to the affidavit sworn by the plaintiff's solicitors on 22 March, 1996, are Crumlin Hospital standard laboratory test request forms indicating the clinical diagnosis of infective hepatitis in November/December 1976. As I have already mentioned, my Department and the expert group knew before the establishment of the expert group on 4 March 1994 that there was a clinical diagnosis for this donor of infective hepatitis in November 1976. While the Crumlin Hospital standard laboratory test request forms attached to the affidavit sworn by the plaintiff's solicitors on 22 March 1996 were not seen by the expert group, it and the Department of Health were aware of the clinical diagnosis and the outcome of the subsequent laboratory tests, as I have already outlined. When the information on the clinical diagnosis was given to my Department and to the expert group, documentary evidence in this regard was not sought or required for their purposes.
In the light of the details which I have set out, I will deal now with the alleged contradictions between statements made by me and the Minister of State Deputy O'Shea, and reports in the media in recent days following the attendance of the chief executive of the BTSB at a meeting of the Committee of Public Accounts on Thursday, 25 April. My officials have been in contact with the chief executive of the BTSB and the following is the position.
The allegations in the media are to the effect that the expert group did not see a particular file and, therefore, were not fully informed on the clinical diagnosis of infective hepatitis of the donor to the plasma pool used in the manufacture of the anti-D product in 1976-77 and that the Minister of State had been presented with this file before he spoke in the Dáil on 28 March.
While the file referred to by the chief executive officer of the BTSB at the meeting of the Committee of Public Accounts was not seen by the expert group, I reiterate that the expert group was fully informed and fully aware from the outset of its work of the clinical diagnosis of infective hepatitis in the light of the BTSB's letter of 25 February 1994 to the Department of Health.
I understand that the chief executive officer of the BTSB told the Committee of Public Accounts that he was of the view that the Minister of State would have been aware of the existence of the file in question. The fact is that the Minister of State, while aware of the existence of the file, had not seen the file.
I outlined earlier in this reply that no internal file of the BTSB was ever forwarded to my Department. However, as I have already mentioned there were a number of Crumlin Hospital standard laboratory test request forms attached to the affidavit sworn by the plaintiff's solicitors on 22 March 1996 and they form part of the current court proceedings. I have now been informed that these standard laboratory test request forms relating to the plasma donor form part of a particular file which has been discovered to the plaintiff's solicitors as part of the proceedings.
The expert group on the BTSB investigated fully the circumstances surrounding the contamination of the anti-D product. The High Court proceedings which are fixed to commence on 8 October next will involve a judicial examination of and determination on this matter. In the circumstances, to establish a special judicial inquiry would serve no useful purpose and would be inappropriate.
It would not be appropriate for me to publish the papers which form the basis of the expert group report. These documents are, for the greater part, documents from the BTSB to the expert group and were forwarded on a confidential basis. They have, however, been disclosed in accordance with a High Court order in the course of the proceedings before the High Court. Documents discovered in compliance with a court order can only be used by the parties to the proceedings for the purpose of the legal proceedings before the court.
I have placed no restrictions on the members of the expert group to make public comments. It would be inappropriate for me to do so.
For the information of the House, to date the compensation tribunal has received 342 applications and since its commencement has heard 44 cases. The awards made to date by the tribunal range from £20,000 to £324,321 and no tribunal award has been rejected. I understand that approximately £4.5 million has been awarded to date by the compensation tribunal. The tribunal is running smoothly, fairly and efficiently as I had envisaged. The closing date for applications is 17 June 1996. The tribunal has hearing dates arranged until 18 June 1996.