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Dáil Éireann debate -
Thursday, 6 Apr 1995

Vol. 451 No. 7

Ceisteanna — Questions. Oral Answers. - Report on Blood Transfusion Service Board.

Máire Geoghegan-Quinn

Question:

1 Mrs. Geoghegan-Quinn asked the Minister for Health when he will publish the reports by the Blood Transfusion Service Board and Dr. Miriam Hederman O'Brien on the investigations into the contamination of the blood product Anti-D; the action, if any, he intends to take on the basis of these reports; and the measures, if any, he intends to introduce to improve openness, transparency and accountability at the blood bank. [7148/95]

Liz O'Donnell

Question:

3 Ms O'Donnell asked the Minister for Health if he has requested the resignation of any of the members of the Blood Transfusion Service Board in view of the recent report of the British Medicines Control Agency on the operations of the board and its services; the measures, if any, he proposes to take to ensure that the operation of standards at the Blood Transfusion Service Board, particularly in Pelican House, are brought up to EU standards; and if he will make a statement on the matter. [7188/95]

Michael Ahern

Question:

19 Mr. M. Ahern asked the Minister for Health if he will publish the accounts of the Blood Transfusion Service Board. [7006/95]

Máire Geoghegan-Quinn

Question:

20 Mrs. Geoghegan-Quinn asked the Minister for Health the co-ordination of services available for women and their families affected by hepatitis C through contaminated Anti-D in the areas of quality medical care, quality comprehensive counselling and quality continuously up-dated information. [6998/95]

Peadar Clohessy

Question:

27 Mr. Clohessy asked the Minister for Health when he proposes to publish the special report on women who have contacted the hepatitis C virus arising from the Anti-D treatment; and if he will make a statement on the matter. [7060/95]

Michael Ahern

Question:

36 Mr. M. Ahern asked the Minister for Health if blood or blood products were exported by the Blood Transfusion Service Board without the consent of donors or any explicit Government approval; and if he will make a statement on the matter. [7005/95]

Charlie McCreevy

Question:

44 Mr. McCreevy asked the Minister for Health the amount of compensation which will be paid to women infected with hepatitis C in view of Anti-D contamination; when the compensation will be paid; and if he will make a statement on the matter. [7004/95]

Dan Wallace

Question:

46 Mr. D. Wallace asked the Minister for Health the plans, if any, there are to close the blood bank in Cork; and if he will make a statement on the matter. [7010/95]

Máirín Quill

Question:

52 Miss Quill asked the Minister for Health if the special report on hepatitis C has been presented to Government; and if he will make a statement on the matter. [7070/95]

John Ellis

Question:

60 Mr. Ellis asked the Minister for Health the changes, if any, introduced in procedures and security at the Blood Transfusion Service Board in view of the report by the British Medicines Control Agency that the Abbott flexible pipetting centre machine which screens blood for viruses was found improperly cared for; if any contamination has resulted from this maintenance problem; the actions, if any, pending against the Blood Transfusion Service Board; and if he will make a statement on the matter. [7015/95]

Ivor Callely

Question:

76 Mr. Callely asked the Minister for Health if he will make a statement on the level of public confidence in our national blood services, in particular in relation to infected blood products; and the way in which he intends to address the public concern following the hepatitis infection. [7147/95]

Limerick East): I propose to take Questions Nos. 1, 3, 19, 20, 27, 36, 44, 46, 52, 60 and 76 together.

As the Deputies will be aware, I published the report of the expert group on the Blood Transfusion Service Board yesterday and I circulated a copy of the report to every Member of the Oireachtas for their information together with the press release which accompanied it.

The policy document, A Government of Renewal, of December 1994 included a commitment to fair compensation for women infected by the hepatitis C virus from Anti-D. I am pleased to be able to honour the Government's commitment to women affected by the hepatitis C virus from Anti-D and their families.

The Department is in detailed discussion with the Attorney General's office with regard to setting up the compensation tribunal. Consultations are also ongoing on this issue between the Department of Health and Positive Action, the support group for women with hepatitis C and their families. It will be a matter for the compensation tribunal to decide on individual offers of compensation.

I am concerned to ensure that an effective mechanism be put in place as quickly as possible to administer the ex-gratia compensation scheme and I am hopeful that all those affected will find the tribunal an acceptable, prompt and informal setting in which to deal with the compensation issue.

The expert group, in its report, made a number of recommendations in relation to the organisation and management of the Blood Transfusion Service Board and the National Drugs Advisory Board.

To support the board of the Blood Transfusion Service Board in implementing the necessary improvements required immediately in the workings of the Blood Transfusion Service Board, I announced yesterday that the Government has approved the assignment of Professor Shaun R. McCann, Consultant Haematologist, St. James's Hospital and Mr. Liam Dunbar, Chief Executive Officer, St. James's Hospital, as advisers to the board for a period of up to a year.

I announced in February that the Government had approved the appointment of Bain and Co., a consultancy firm with special expertise in the area of blood transfusion services, to carry out a thorough and in depth major review of all the workings of the Blood Transfusion Service Board. The Bain and Co. project is well under way and is expected to be completed by the end of this month.

I have not requested the resignation of any member of the board of the Blood Transfusion Service Board and I have every confidence in the board under the new chairman, Mr. Joe Holloway. I should point out that nine of the present 12 board members have been appointed since 31 August 1993. I understand Mr. Holloway was appointed appointed in September 1994.

I assure the House that there are no plans to close the Blood Transfusion Service Centre in Cork. The accounts of the Blood Transfusion Service Board, which are audited by the Comptroller and Auditor General, for the year ended 31 December 1994 will be published shortly.

I also announced yesterday that a new permanent chief executive officer of the National Drugs Advisory Board will take up duty early in June. Work is proceeding on the preparation of new legislation which will replace the National Drugs Advisory Board with a new Irish medicines board, which will become the licensing authority for all medicines.

In addition, arrangements are in train to recruit a management consultancy firm to undertake a thorough and independent assessment of all aspects of the organisation and management of the National Drugs Advisory Board in anticipation of the requirements of the legislation.

It has not been cost effective for the Blood Transfusion Service Board to manufacture all blood products required for our health services. Plasma from Irish donors over the years has been sent to specialist pharmaceutical companies for fractionation to ensure an adequate supply of the various blood products required for Irish patients. To ensure cost effectiveness, the contracts between the Blood Transfusion Service Board and these specialised pharmaceutical companies usually contain a clause that surplus plasma which is not required to meet Irish needs can be used by the pharmaceutical companies to manufacture products for use in other countries. On this issue, I would point out that a detailed review of the current policy for sourcing of plasma products and an investigation of the strategic options available to the Blood Transfusion Service Board is one of the terms of reference of the Bain and Company consultancy project which will report in about three weeks. The preferred option will be that which best ensures the reliable supply of the highest quality plasma derived products in the future, at the minimum cost to the Irish health service and at maximum safety.

The Blood Transfusion Service Board, in consultation with the National Drugs Advisory Board, is addressing the various issues raised in the Medicine Control Agency's report. The board's facility will be reinspected to ensure that its medical practices are up to highest international standards.

In relation to the Abbott Flexible Pipetting Centre, the Blood Transfusion Service Board has advised me that the correct procedures are now in place and the the board is satisfied that no product has been contaminated as a result of the deficiencies identified by the Medicines Control Agency. The security issue identified in the report is being addressed by the board as a matter of urgency.

The issue of public confidence in the blood transfusion service is of major concern to me. The Government decisions that I announced yesterday are crucial in maintaining public confidence. It is an ongoing challenge to ensure an adequate level of blood donations for the needs of the health service and it is vital that the present level of donations is at least maintained. In excess of 3,000 blood donations are needed every week to meet hospital needs.

Treatment and support services are in place for some time to meet the needs of those who have tested positive for hepatitis C under the national blood screening programme. Treatment for those who test positive for hepatitis C is being provided at the following six designated hospitals: Beaumont Hospital, Dublin; Mater Hospital, Dublin; St. James's Hospital, Dublin; St. Vincent's Hospital, Dublin' Cork University Hospital and University College Hospital, Galway.

The treatment initially involves an out-patient visit which may be followed by a short admission for clinical investigation and follow up treatment, if required.

A counselling programme involving medical staff at the Blood Transfusion Service Board and general practitioners throughout the country was put in place by the Blood Transfusion Service Board for persons who received the Anti-D product. Persons who tested positive for hepatitis C under the national blood screening programme were also invited to Blood Transfusion Service Board consultations which took place in Dublin, Waterford, Wexford, Kilkenny, Clonmel, Cork, Limerick and Galway. To support the Blood Transfusion Service Board counselling services, a counselling programme was also structured by it with the Well Woman Centre Dublin. Large group information meetings on hepatitis C were also held in Dublin, Waterford, Cork, Tralee, Limerick, Galway, Castlebar, Sligo, Monaghan, Mullingar and Donegal. The recommendations contained in the expert group report regarding counselling are being considered urgently by my Department in consultation with the Blood Transfusion Service Board.

I assure the House that the services put in place for persons who have tested positive for hepatitis C under the national blood screening programme will be available for as long as they are required. The needs of those who have been diagnosed as positive for hepatitis C will be monitored and re-assessed on an ongoing basis to ensure that the necessary support services are provided to meet their needs.

Does the Minister accept all the recommendations and will he implement them in full? Can he give the timescale in which full implementation will take place?

(Limerick East): As the Deputy is no doubt aware the expert group report is published in full. It draws conclusions and makes recommendations. Those recommendations will be implemented. Some are a matter for me and others are a matter for the new men appointed as advisers to the blood bank and for the board of the Blood Transfusion Service Board, together with the chairman, Mr. Joe Holloway. Many of the recommendations are of a general and policy nature. Explicit recommendations on the day-to-day running of the service and plotting future strategy will come from the terms of reference of the consultncy firm Bain and Company. I envisage that report, which will be available in three weeks, will be a blueprint for action for Mr. Liam Dunbar and Professor Shaun McCann who are now effectively in charge of the Blood Transfusion Service Board.

I cannot help but remark that the Minister's response to the series of questions on this blood bank scandal fails to reflect the gravity of the situation. The Minister said in his response that he did not request any resignations. Why did he not do so, given the double indictment by the expert committee on hepatitis C and the report of the Medicines Control Agency on the operations of the board? Given the findings of both those reports why did the Minister not request a resignation?

(Limerick East): It is ludicrous to suggest I am not aware of the gravity of the position in the context of the announcements I made yesterday. The Deputy misquoted me in her supplementary. The question related to whether resignations would be sought from board members and I pointed out that no resignations are being requested from board members. I further pointed out that Mr. Joe Holloway, who is chairman of the board, was effectively brought in last September to sort things out. The board consists of 12 persons and nine of them have been appointed as recently as during the last 17 months. Their appointments were subsequent to the main events which led to the expert group being brought in and the preparation of a report on the activities of the board.

The letter from Middlesex Hospital on 16 December was addressed to the chief medical consultant. Who took the decision not to act on the information contained in the letter?

(Limerick East): I have been assured by Dr. Miriam Hederman O'Brien that all the information available to her about the incident is contained in the text of the report and that she has no other information that would throw further light on the subject. I will briefly summarise what is in the report rather than quote from it. Deputies who have read it will be aware that the events relating to this matter commenced in 1976 to 1977. At that stage hepatitis C was not identifiable as a separate form of hepatitis. In 1989 hepatitis C was identified in laboratories as separate. Some of the samples of blood tested in Middlesex arising from the 1977 incident had been achieved in Middlesex. When hepatitis C was identified as a separate hepatitis the archive samples were taken out of refrigeration and tested. The people in Middlesex became aware that hepatitis C was the cause of the problem that arose in 1977 and they informed the chief medical consultant of the Blood Transfusion Service Board by letter. According to the report, he appears to have passed the information to one of his subordinates who was head of a particular section. A reply was sent to Middlesex suggesting that the chief medical consultant would take up the matter when he went to London some time in mid-January 1992. We do not know any more about the matter, despite the best efforts of the expert group to establish the facts. It is clear that nothing further happened after mid-January 1992.

Will the Minister not agree that the two reports, particularly the report of the expert committee, have found that the main problem was a failure on the part of management, both administrative and medical? Will he clarify that he did not seek the resignations of the people who have resigned? Will he further clarify the status of the two people he has appointed to take their place? Are they full-time positions and what is their remuneration? Is the Minister satisfied that these two people can be adequately vigilant in respect of the quality of blood products and the total management of the service, at least in the interim until further recommendations are made as a result of other inquiries?

(Limerick East): The Deputy has asked a series of questions. The report speaks for itself and I will not put another type of spin on the report by putting things another way.

Does the Minister agree with its findings?

Let us hear the Minister's reply without interruption.

(Limerick East): A full report has been presented. I have full confidence in the people who brought it forward. It states what happened in accordance with the evidence available to them.

Regarding resignations, I have confidence in the board. Many of its members were appointed recently and did not preside over the events which led to this report. Mr. Joe Holloway in particular was brought in to sort out the affair. The chief executive and the chief medical consultant asked if they could retire. There was no question of my seeking their resignations because they indicated they were retiring from their positions.

Regarding the status of the new people coming in, statutory authority for running the blood transfusion service is vested in the board. From a legal point of view those two people are coming in as advisers to the board and they will have full responsibility for the board in that capacity. In terms of the day to day running of the board, Professor Shaun McCann is coming in as the chief medical consultant and Mr. Liam Dunbar is coming in as the chief executive. In terms of the hierarchy, the report is critical of the dual system which developed in the mid-1980s where, in effect, there was no director of the blood transfusion service; there was a medical and an administrative stream but effectively no boss. In this instance Mr. Liam Dunbar will be the manager and, therefore, a hierarchy will be established. He is being seconded on a full-time basis from St. James's Hospital where he is currently employed; Professor Shaun McCann has some commitments in St. James's Hospital with which he will continue. The public will be aware that he is the man whose name is frequently mentioned in the context of bone marrow transplants and he has some responsibilities which he will continue to carry out.

We are particularly lucky that those two men have agreed to come in. This is not a career move — they are making this move in the public interest. It was put to them that they might, because of their status in the provision of services, come into the board in the public interest. They have agreed to stay with the Blood Transfusion Service Board for 12 months to carry out the necessary reform. The board is a sheltered organisation which has been isolated from other areas of health provision because of its location and for other reasons. Those people have the recommendations of the report which are important, but they also have the ongoing recommendations of Bain and Company who have gone through the detailed running of the board with a fine comb. I have been informed that the full report of Bain and Company will be available at the end of April. Those people are well positioned to sort out matters. I do not know how things will pan out at the end of the day. Obviously I am not going to tell them what to do in every detail. They are eminent people and they will carry out their duties in accordance with the board. They are coming into the board on a temporary capacity and do not want to stay there permanently. I presume that when the matter is sorted out their positions will be advertised in 12 months' time or later. Those arrangements will be made when full confidence has been restored in the board and we are sure that the organisation is operating efficiently and effectively to the best international practice, providing the type of blood transfusion service we need.

I wish to refer to the letter——

I want to bring the questions on this subject to finality. Members will observe that almost all the time available to us for dealing with priority questions is now very nearly exhausted.

A Cheann Comhairle, you will accept that the Minister gave a comprehensive reply which was essential and took some time, which we appreciate. Regarding the letter from Middlesex Hospital, will the Minister agree that it is not good enough that Dr. Miriam Hederman O'Brien and her expert group were unable to establish who took the decision to ignore the Middlesex letter? Does he not consider it would be a function of the chief medical consultant to make a decision on such a letter rather than his subordinate? Will he confirm that the Department of Health was notified about the contents of that letter about one month after it arrived in the Blood Transfusion Service Board? Can he tell us what date it arrived in the Department, who was notified in the Department and what action that person took on receipt of the information?

(Limerick East): All the information available about that letter is contained in the report. The letter was sent to the chief medical consultant at the Blood Transfusion Service Board in the circumstances I described in reply to a previous supplementary. He certainly forwarded a copy of the letter to a head of staff who was subordinate to him. As far as the expert group can establish, nobody else was aware of it. I have been assured that the chief executive of the Blood Transfusion Service Board was not aware of it. Within the hierarchy of the Blood Transfusion Service Board the haematologist consultant in Cork is second in command and would not have known about this. Deputy Geoghegan-Quinn will recall that it was the statistical match she undertook which saw a relationship between women who had received Anti D, now infected by hepatitis C, which brought in the evidence two years later which gave rise to the screening programme. It is not true — I do not know where the Deputy heard the story — that anybody in the Department of Health was aware of this. In respect of that letter no culpability attaches to anybody in my Department. It appears from the report that no decision was taken, that it is an omission, not a commission.

The Minister stated these two new appointees are advisers to the Blood Transfusion Service Board. Will he comment on the finding of the report that board members frequently failed to attend meetings over the period in question and agree that this raises a question of their commitment if, at times, they failed even to obtain a quorum? Will he also agree that those members appointed to a State board such as this — whose responsibility is to monitor a very important public policy area — who attend board meetings should be congratulated but that others who do not over a long period should have their board membership terminated? Furthermore, does the Minister agree that this report fails to deal with those people infected with the hepatitis C virus from blood transfusions as distinct from the Anti D element?

(Limerick East): While there is criticism of board members in the report, it does not apply to current board members. This research and report of the expert group ranges from events in 1976 up to just before Christmas 1994 and makes two criticisms of the manner in which the board operated: first, that there were periods in which the Minister of the day did not fill vacancies so that, on occasions, while there was a quorum of members on the board, if there was significant absenteeism on any particular day, it would have been difficult to hold a meeting. The second criticism is of the level of attendance of board members but, again, does not apply to the current board. It would be unfair to endeavour to attach the criticisms, particularly of the late 1980s, to current members of the board who went in, particularly in the case of the chairman, to sort out these problems.

On the question of the objective of the report, what falls within its ambit, the terms of reference are clearly stated in the report, demonstrating that the expert group worked within them.

Yesterday the Minister mentioned a root and branch reorganisation. Does he anticipate that, as part of that reorganisation, a number of other staff members will retire and that the Blood Transfusion Service Board will move its headquarters? Is he personally in favour of its transfer to a hospital location? It was stated in the report that there was no comprehensive list of general practitioners available from the Department of Health when the information pack was issued last year. Is it proposed to draw up such a list and if so, when? On the counselling of victims of the hepatitis C virus, will the Minister say who will provide such counselling, whether it will be comprehensive, available at various locations nationwide and, if so, how soon?

I do not accept that the decision on the Middlesex letter was just a serious error. I consider it was bordering on criminal negligence. Is the Minister aware that court action was taken in France not so long ago on a similar issue? Does he envisage court action here if it is established who made the decision in relation to that letter?

(Limerick East): I inherited all these events and their consequences, on taking office on 15 December 1994. The Middlesex letter was issued in December 1991 when I think the Deputy's party was in office.

It is difficult to trace these things, there have been so many changes but I think the Fianna Fáil-Progressive Democrats Government was in office at that time. I do not think there was any political culpability at any point throughout these events. The Blood Transfusion Service Board is the statutory authority for running the service and the role functions of a Minister for Health are limited. Before people get too excited it is as well to put these things in proper context.

It is not a matter for me as to whether there will be other resignations or dismissals of heads of staff at the Blood Transfusion Service Board as a Minister would not know who was an effective member of staff. I know very good people have been employed by the Blood Transfusion Service Board over the years and that there are excellent people manning the mobile clinic nationwide. Indeed it is worth pointing out that if the Anti-D product had not been administered to mothers since 1970, at least 2,500 infants would have died. It must be put in that context. We must remember also that modern medicine, if it did not have blood available could not function as it covers heart surgery, hip replacements, accidents and emergencies. It takes approximately 3,000 blood donations per week to keep our medical system going.

It is a matter for the new men who have taken over to decide what they want to do in terms of personnel and how they reorganise the service, in which difficult task they have the full authority of the board and my blessing. Whether the Blood Transfusion Service Board will continue to have its headquarters at Pelican House is a matter on which I am prepared to hear the recommendations of the new appointees. There is a strong argument for its relocation on the site of a hospital, thus ensuring an interrelationship between the medical personnel of the board and their colleagues at the cutting edge of medicine. It is also argued that kind of dynamic would ensure the medical people were constantly up to best practice through contact with their colleagues.

A rumour has been circulating in Cork — which is very hard to scotch — that somebody intends closing down the Cork facility, that there is a recommendation from Bain and Company to do so. That is not true; Bain and Company have not been asked, or have not made such recommendations. I assure the people working in the blood transfusion service in Cork and others concerned, including many Members, that that is not within their terms of reference, that there is no such suggestion that that will happen.

Will the Minister respond to my question about counselling?

(Limerick East): Yes, counselling is very important. I, too, was surprised at the lack of a comprehensive list of GPs. It has been explained to me that while GPs on the GMS list would be listed in the Department of Health, GPs not on that list could be in private practice anywhere and are not registered. The professional bodies would be helpful and the General College of Medical Practitioners would have a list but there is a small minority of GPs who are not members of any organisation and there is no way of guaranteeing they are on the comprehensive list. The Department has tried to have as comprehensive a list as possible within those constraints.

Some counselling co-ordinated by the Well Woman Centre has been very effective, but I am concerned that it is not sufficiently comprehensive. I will speak with Mr. Liam Dunbar and Professor Shaun McCann to ensure it is comprehensive and is available on a sufficient geographic spread to make it easy for women to avail of it on an ongoing basis. One tends to look at the compensation and medical elements. Advice and counselling is important to the many women who have been unfortunate to either have been exposed to the antibodies or to have contracted hepatitis C.

The time available to us for dealing with priority questions is now clearly exhausted. I can, however, in accordance with new procedures adopted by the House, proceed to deal with Questions Nos. 4 and 5.

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