asked the Minister for Health, in the interest of allaying widespread public concern, to make an immediate statement regarding the damning report of the British Medicines Control Agency on the Blood Transfusion Service Board.
Private Notice Question. - Investigation into Blood Transfusion Service Board Procedures.
Limerick East): I am glad to have this opportunity to respond to the issues raised by Deputy Geoghegan-Quinn.
In July 1994, the medical technical staff of the Blood Transfusion Service Board put a proposal to the chief executive officer to the effect that the premises of the BTSB be inspected by inspectors in that area to ensure that the BTSB was complying with EU guidelines on good manufacturing practice. These guidelines are applicable to pharmaceutical manufacturing and are for the purpose of ensuring the highest possible standards.
In August 1994 the board of the BTSB agreed that the British Medicines Control Agency, supported by the National Drugs Advisory Board, should carry out the inspection. Between 6 and 8 February 1995, an inspector from the British Medicines Control Agency, accompanied by an inspector from the National Drugs Advisory Board, inspected the BTSB to see if the BTSB was complying with EU guidelines on good manufacturing practice. On 13 February 1995, the British Medicines Control Agency forwarded a report of its findings to the BTSB. The board was very concerned about the contents of the report and took immediate steps to rectify the deficiencies identified. When this report was brought to the attention of my Department I requested and received a detailed response from the BTSB on the matters identified in the report.
I have been assured that many of the matters identified have already been rectified, and the board has given me a firm commitment that the outstanding matters will be rectified at the earliest possible date. The board has also assured me that the future management and medical practices of the BTSB will reach and, where possible, exceed international standards for blood transfusions. To underpin this commitment, the board has advised me of its intention to have its premises inspected at regular intervals to ensure that the board is complying with EU guidelines on good manufacturing practice.
Since coming into office I have been concerned to ensure that the BTSB would work in the most effective and efficient manner. The Government has already agreed to fund a major consultancy project at the BTSB. This project, which is now under way, involves a wide-ranging and fundamental review of the overall management of the BTSB. I am committed to ensuring that the highest standards apply to all activities of the Blood Transfusion Service Board which is an important, crucial service without our health service.
Can the Minister explain why it was not until August 1994, when the board agreed to accept the proposal put to it in July 1994, that the Blood Transfusion Service Board procedures were investigated, having regard to the fact that it had been given the hugely important task by the Minister's predecessor in February 1994 of establishing the National Screening Programme Centre, and had a role in the screening, testing and investigative process in relation to Anti D and the hepatitis C infection?
(Limerick East): A number of outside agencies have been examining the work of the Blood Transfusion Service Board in recent months and years. The report of the expert group under Dr. Miriam Hederman-O'Brien, which examined the difficulties that arose when a number of women contracted hepatitis C, is now to hand. The Deputy, as a Minister in the Government which commissioned that report, will be aware of the circumstances which gave rise to that. The second investigation is being carried out by Bain and Company, an English consultancy group with particular expertise in haematology which has carried out similar work for the blood transfusion services in the United Kingdom. It is now examining the procedures and the efficacy of the Blood Transfusion Services Board and has been doing so for the past three or four weeks. A third project was an inspection of Pelican House and its operations which concentrated on the laboratory area. This was commissioned by the board on the advice of its own medical and technical staff. The inspection was carried out by an inspector of the British Medicines Control Agency and an inspector of our own National Drugs Advisory Board between 6 and 8 February. It was their report that was sent to the board of the BTSB and which appeared, in an expurgated form, in The Cork Examiner this morning.
I am not in a position to say why nothing was done sooner. I was not Minister at the time and there was a different Government in office. However, I am taking the difficulties of the Blood Transfusion Service Board extremely seriously. Mr. Joe Holloway was appointed last year as chairman of the Blood Transfusion Service Board and I am in regular contact with him to ensure that the service provided by the board complies with best international practice. To put things in context, let me say that the whole question of blood transfusion services internationally are a matter of concern in health services, that we must ensure we comply with best international practice so that the confidence of the voluntary donors who have done so much over the years by donating blood can be maintained. The confidence of the recipients must also be maintained and I intend to make sure that it is.
I am concerned, too, to maintain the confidence of both donors and recipients. It is for that reason that I raised the Matter. There are many women who have hepatitis C as a result of receiving contaminated Anti D serum, who are anxious to know how that contamination happened and to see standards in place to ensure, in so far as possible, that this can never happen again. In relation to the report in the newspaper today was there a lack of security and could the product have been interfered with? Is there a possibility of contamination?
(Limerick East): I confirm that the report in The Cork Examiner, in so far as it quotes directly from the report on the inspection carried out by the British Medicines Control Agency, is accurate. It points to a number of inadequacies which are in the process of being put right by the Blood Transfusion Service Board under the direction of its chairman. I am informed that there is 24 hour round the clock security at Pelican House but that security within sections needs to be improved as one can gain unsecured access from one area to another. That is a cause of concern.
On the issue of contamination, we should not confuse the events which led to the establishment of the Dr. Miriam Hederman O'Brien specialist group following incidents in 1977 with this two day inspection carried out between 6-8 February this year. An item in the report in The Cork Examiner was carried in the headlines to the effect that blood bags were stored in unhygienic conditions. I am informed there was no possibility of contamination, that blood bags were contained in sealed containers. It is not acceptable that they were stored in such conditions; it is not an acceptable practice.
It is not acceptable that people were allowed to penetrate security provided on a 24 hour basis, especially in a premises where the highest international standards have to be maintained. What do the 24 hour security measures entail? Will the Minister outline the critical and major failures identified during the inspection in terms of proper manufacturing practice and indicate if the blood bags were stored in fridges?
(Limerick East): The normal 24 hour security measures that one would expect at a premises were taken. As a former Minister for Justice, the Deputy will be aware of the security measures to which I refer. There was no question of security being breached. Best international practice would dictate that in a premises where blood products are dealt with employees and visitors should not be able to gain easy access from one area to another. That is the security problem identified in the report and being remedied at present.
On the question of what the inspector of the British Medicines Control Agency and the inspector of the National Drugs Advisory Board discovered, it is all contained in the report in The Cork Examiner. The report runs to about three pages and each paragraph points to a particular issue. As might be envisaged, this was not a spot inspection by an outside agency; it was requested by the Blood Transfusion Service Board to carry it out. The board is now implementing the recommendations contained in its report.
I understand that the British Medicines Control Agency has carried out similar inspections in the United Kingdom where it has identified similar difficulties. It also intends to inspect the premises in Cork shortly. I presume by the time its inspectors reach Cork everything will be shipshape. A series of issues arise and others will arise as soon as I am in a position, in accordance with legal advice, to publish the Dr. Miriam Hederman-O'Brien report.
I find it extraordinary that these defects were identified during an inspection requested by the board. One would have thought that it would have put whatever was wrong right in advance of the inspection. I find it even more extraordinary that the normal international standards were not being adhered to in Dublin. This may be the case in Cork also. Who sets the standards for the BTSB in relation to storage, record keeping, security and laboratories? Was the attention of the Department drawn to any administrative weaknesses in the organisation some time ago?
(Limerick East): At the risk of making a political point the Deputy's party was in Government for the past seven years during which there was a number of Fianna Fáil Ministers for Health. If she was amazed at the report she can imagine my amazement when I discovered a number of things when I entered the Department of Health. However, we can discuss those issues another day.
On the question of best practice, there are EU guidelines on good manufacturing practice. The inspection was requested to ensure that these guidelines were being complied with. As well as licensing medicines the National Drugs Advisory Board also license blood products. That is the reason one of its inspectors was present.
Like the Deputy, I was surprised that the inspectors issued such a critical report following an inspection requested by the board. The sequence of events is as I outlined. The suggestion was made in July 1994; the board agreed to comply with it in August 1994 and made arrangements to have the inspection carried out between 6 and 8 February 1995. In the context of what Bain and Company is doing in the blood transfusion service at present it is a small job. I expect it to present more all-embracing recommendations. I would like to take those two jobs of work with the Dr. Miriam Hederman-O'Brien report which is now available. I will give the House as much information as possible in due course about all these matters when it will have an opportunity to discuss the efficacy or otherwise of the Blood Transfusion Service Board in greater detail.
To avoid causing a scare — the report in the newspaper this morning could easily cause a further scare for both donors and recipients and we do not want this to happen — will the Minister give a commitment that all the deficiencies identified by the British Medicines Control Agency will be rectified immediately and outline the timescale within which this will be done? Rather than having all these reports, the Dr. Miriam Hederman-O'Brien report, the report of the Blood Transfusion Service Board and this particular report, leaked to the press — I make a political point — in the interests of openness, transparency and accountability will the Minister publish the relevant parts of these reports to allay public concern?
(Limerick East): I can give a commitment that the recommendations contained in this report have now been implemented by the Blood Transfusion Service Board. I understand one recommendation is the subject of discussion between the board and the agency but all the others have been implemented. This will be implemented in due course.
Which one is that?
(Limerick East): I would have to go back over everything again and we would be into a Second Stage speech but if the Deputy has a copy of The Cork Examiner I will go through it with her later.
On the issue of the publication of reports, the Deputy will be aware, particularly in her capacity as a former Cabinet Minister, that a major difficulty gave rise to the setting up of the expert group under Dr. Miriam Hederman-O'Brien. I am committed to the publication of that report in as full a manner as I can in accordance with the legal advice I will get.
When?
(Limerick East): As quickly as possible. I am talking short term, not medium or long term.
Is the Minister talking about weeks?
(Limerick East): I have to go to Government on this because it was commissioned by the Government. I am not fully in control of the timetable but I expect to be going to Government within weeks.
Will the Minister use his considerable influence in Government?
(Limerick East): I will.
Has any official of the Minister's Department held a position as a member of the Blood Transfusion Service Board in the past four or five years? Will the Minister give his opinion as to whether the Blood Transfusion Service Board is guilty of incompetence, inefficiency and serious neglect in this matter?
(Limerick East): I have full confidence in the Blood Transfusion Service Board under the chairmanship of Mr. Joe Holloway whom the House will recall was secretary at the Department of Energy. I believe he was secretary when Deputy Molloy was Minister for Energy.
No.
(Limerick East): On the question of the membership of the board and whether there was departmental representation over the past four or five years, I do not have that information to hand and I do not want to mislead the House. I will make inquiries in this regard and communicate by letter with Deputy.
The Minister omitted to comment on whether there was inefficiency, incompetence or neglect involved in this matter.
(Limerick East): As I said, I have full confidence in the board. If a board was guilty of any of the things suggested by the Deputy, a Minister could not have confidence in it.
The Minister is happy with what happened.