I will call on the Deputies who tabled questions to the Minister for Health and Children in the order in which they submitted their questions to my office.
Private Notice Questions. - Contaminated Blood Product.
asked the Minister for Health and Children when the Irish Medicines Board and his Department were informed that a potentially contaminated batch of Amerscan Pulmonate II had been administered to patients in the State; the number of patients concerned; the reason that, prior to the withdrawal of the products batch being reported by the media, no steps were taken to inform those to whom the product was administered of the potential risk, if any, to their health; and if he will have arrangements made for them to receive the necessary medical counselling and advice.
asked the Minister for Health and Children when the attention of the Irish Medicines Board was first drawn to the fact that people in this country had received Amerscan Pulmonate II which had been made from the plasma of a donor who later developed the new variant CJD; when the board informed his Department; the reason his Department did not take immediate steps to notify those involved; the steps, if any, which are currently being taken to alert and assist those who received the product; the steps, if any, being taken to determine whether those who received the product subsequently gave blood donations; the steps, if any, being taken to reassure those who had medical investigations for lung conditions, not involving the use of Amerscan Pulmonate II, they are not at risk; and if he will make a statement on the matter.
(Dublin West) asked the Minister for Health and Children when all relevant hospitals were alerted to the problem of Amerscan Pulmonate II agent, once the Irish Medicines Board was informed of a CJD link; and the patients, if any, which had the suspect Amerscan Pulmonate II agent administered after the Irish Medicines Board was informed.
asked the Minister for Health and Children the chronological details of the events in relation to the withdrawal of the blood product Amerscan Pulmonate II particularly in relation to the persons and bodies involved and the information given to these; and the measures, if any, which have been, and are being, put in place to properly inform those who were treated with this product.
asked the Minister for Health and Children the measures, if any, he has put in place to inform people exposed to contaminated blood product Amerscan Pulmonate II; the planned timetable under which these people were to be informed; if he will outline the proposals, if any, he has for a full information and counselling service in this regard; the system, if any, which is in place within his Department to ensure the full withdrawal of Amerscan Pulmonate II; whether he is satisfied with the role played by the Irish Medicines Board in the matter; and if he will make a statement on the matter.
I propose to take all questions together.
Amerscan Pulmonate II is a product used in the diagnosis of abnormal lung perfusion in patients. Certain batches of this product have been recalled by the Irish distributors. The Irish Medicines Board was informed on 18 November by the UK Medicines Control Agency regarding the relevant batches of Amerscan Pulmonate II Agent. The board took immediate steps on 19 November in co-operation with the distributors of the product, to quarantine the unused products and ensure their full recall. All nine hospitals involved have confirmed to my Department that none of the product was used after that date.
The Department became aware of the need for the recall on the evening of 26 November and obtained detailed information from the Irish Medicines Board on 27 November. The Department wrote to the nine hospitals involved on 28 November, emphasising the importance of completing a full recall of the product and asking for formal confirmation that the products had been returned to the distributors. It was subsequently confirmed to the Department by the hospitals that all unused product, having been quarantined, was returned to the distributors by 27 November.
The delay which occurred in the Irish Medicines Board notifying the Department is a matter of concern to me. I have already made it clear to the board that in future I require to be informed immediately of any similar incident and the nature and extent of the board's response to it.
The number of vials of the relevant product which was used is 268. Following the decision to advise patients, taken on 12 December, my Department has now been in contact with each hospital involved and has established that hospitals may treat more than one patient with each vial, depending on the circumstances of each patient. Accordingly, the information from the hospitals today suggests that the total number of patients who will have to be contacted and counselled is up to 467. I have issued a statement this afternoon clarifying the position with regard to the numbers involved.
The Department's assessment of the matter indicated that its handling raised complex medical, scientific and ethical issues. I will elaborate on these later. It was, accordingly, decided to seek the advice of the CJD Advisory Group, which met on 4 December. The group concluded that the risk involved was unquantifiable but likely to be very low. It gave detailed consideration to the ethical issue arising in balancing the benefits which might accrue to the patient knowing of his or her exposure and the possible serious psychological distress which this knowledge might bring. It agreed the chairman should continue to seek ethical advice on this matter. It advised that, if recipients were to be identified and informed, appropriate counselling should be available and that a national policy should be formulated on the handling of the problem. Finally, it considered that it would clearly be inadvisable for these patients to donate blood. During the following week, further consideration was given to the ethical issue having regard to the extremely low risk, the lack of a diagnostic test for new variant CJD, the lack of any treatment and the unknown incubation period of the disease.
On 12 December, the Department's chief medical officer met the chairman and two other members of the advisory group. It was agreed, in principle, that, on balance, patients should be informed of the facts and appropriate mechanisms should be put in place as soon as possible to give effect to this. As Deputies will be aware, the story was reported in the media on the evening of 14 December, the day prior to a scheduled meeting in the Department to make the detailed arrangements for the identification, notification and counselling of patients.
I will outline the arrangements being made to notify patients, having regard to the extreme sensitivity of the issue and the absolute need to maintain the doctor-patient relationship. I am informed by eight of the nine hospitals concerned that they have already identified all the patients who were diagnosed using the product in question. The remaining hospital has almost completed this task. A clinical information pack is being prepared and will be sent to each of the hospitals. This pack will consist of briefing material on the scientific data in relation to Amerscan's composition and operation and on the clinical issues in relation to new variant CJD and the possibility of transmission through this product. Each hospital is being asked to arrange with the appropriate consultants, generally the treating consultants responsible for the care of patients known to have been treated with the relevant batches, to meet each patient individually and to brief them fully on their circumstances using, as appropriate, the background information contained in the clinical information pack. I take this opportunity to request the full co-operation of medical consultants and other hospital staff in carrying through this sensitive task.
Counselling will be arranged by the hospital according to each patient's needs and wishes. Following the initial consultation, the consultant will send a report to the patient's general practitioner and will enclose a copy of the clinical information pack. Copies of this pack are also being made available to the headquarters of each health board, to be given to any general practitioner who may wish to have this information in dealing with his or her patients.
Hospitals will be requested to inform the Department when all patients have been contacted. The Department will then issue a statement so that all those who may have concerns about this matter can be reassured, particularly those who have had medical investigations for lung conditions not including the use of the relevant batches of Amerscan pulmonate II. Hospitals have already been requested to make special arrangements to deal promptly and fully with any queries they may receive from patients who are concerned about their situation, and each has confirmed that this has now been done.
As Deputies will be aware from various commentaries in the last few days, we are dealing with a complex scientific, ethical and practical issue. Such is the uncertainty surrounding both the scientific and ethical aspects, it is already clear that there are a number of possible ways in which the matter can be addressed and defended. As indicated by Dr. Paul Browne of the National Institute of Health in America during a radio interview broadcast on RTÉ this morning, the advice given by the appropriate experts to the Food and Drugs Administration in the USA is that, given the level of risk, this product should not be withdrawn from use. On the other hand, the UK authorities decided to remove the product from use but decided, given the level of risk, the lack of a diagnostic test and of treatment for CJD, that patients should not be informed.
We have decided to do both but, as I have outlined, that decision required a level of consideration and consultation commensurate with the importance and complexity of the issue. The immediate safety aspects were addressed promptly by quarantining the relevant product and subsequently returning it to the distributors. The BTSB confirmed that the questionnaire completed by prospective donors has the effect of excluding any recipients of this product from donating blood. This having been done, time and thought had to be given to getting as much information as possible on the risk involved and, most of all, deciding if and how the patients should be informed. The Irish Medicines Board acted correctly and promptly in arranging to have the product quarantined and withdrawn. The Department acted promptly to reinforce the immediate safety arrangements and dealt with the key ethical issue in an informed and thoughtful manner. I assure the House that all the further steps I have outlined will be implemented immediately.
Does the Minister accept that neither he nor his Department recognised the need for urgent communication with those to whom this product had been administered? Is he aware that this day last week, when dealing with another issue in the House, he stated: "irrespective of how minimal is the risk, I have a duty to inform the public of it"? Does he accept that at the time he said that, he was aware of the difficulties in this area, that no decision had yet been made to inform the public and that his Department was in a dilemma as to what it should do? Does he accept there has been a lack of sensitivity and insight in the manner in which this issue has been dealt with by his Department? Does he acknowledge that it was scandalous that those to whom this product was administered heard about this matter on RTÉ and read about it in the national newspapers and that this is an inappropriate way to deal with such an issue?
I agree with Deputy Shatter that it is unfortunate this matter has come into the public domain before people have an opportunity to be counselled or advised on their position. I was not responsible for bringing this issue into the public domain so I cannot take the credit or blame for it, depending on what side of the argument one wishes to take.
I do not accept that the Department is not committed to its primary objective of helping those who are affected by dealing with this issue. A dismissive attitude has been taken to the complex ethical issues which must be considered.
It has also been suggested that I was inconsistent in my approach to this issue compared to the matter we discussed last week. However, I am taking the same approach. When clear advice was given to me by the CJD expert committee on the meat on the bone issue, I promptly acted on it. When that committee considered this issue, it was not in a position to give clear and complete advice after its first meeting on 4 December. The minutes of the meeting I outlined in my statement confirm that it sought further advice from within the committee and from the Irish Medical Council on the ethical issues involved. Every medical person who has commented on this issue supports the view that this matter raises serious ethical issues. My approach has been consistent because when it was decided on Friday, 12 December that complete advice could now be given to me and that the patients concerned should be informed, I immediately acted on that advice and a scheduled meeting was fixed for Monday, 15 December to begin the process of identifying, notifying and counselling those patients.
I have also been criticised for not meeting those contingencies sooner. I was not in a position to act on this matter until the medical and ethical issues had been resolved. It would not have been proper or appropriate for me to involve the hospitals in a scheme involving the identification of patients before I had been fully advised by the CJD expert committee on whether it was ethical to pursue that course of action.
What I did was totally consistent with the approach I have taken in these matters. The problem with this matter compared to the other one is that it is more complex and therefore more consideration must be given to it. If the Deputy wishes, I can quote from the chairman of the CJD expert committee, who is a consultant virologist, professor of microbiology and head of the virus reference laboratory in UCD. The line of political attack is flawed to the extent that it seeks to dismiss the serious ethical issues involved in this case which have been confirmed by the medics.
Does the Minister acknowledge that this is not a political attack but is about informing individuals to whom a product has been administered? Does he also acknowledge that the central ethical issue is whether to inform or not to inform such individuals and that as Minister he must make that decision? The Minister cannot tell the House last Tuesday about an obligation to inform on minimal risks and then come into the House today and say this is not a decision he makes. He decides how to deal with information based on what other people tell him. Will he clarify and confirm that in future, if a similar difficulty arises, those who may be affected by it will be informed more quickly? Will he also clarify why his officials withheld information from him for five days and it then took him a further two weeks to make a decision that should have been made within 24 to 48 hours?
The issue eventually crystallised itself as to whether the patients were to be informed. The medical advice upon which I depend before making the decision — and it would be a very irresponsible Minister who would make such a decision without medical advice — became available to me on December 12, last Friday.
But the Minister knew two weeks earlier.
I am seeking to answer the Deputy's question. I agree this should not be about political attacks but the Deputy will be aware——
(Interruptions.)
What about the Tánaiste?
Ten out of ten for a hard neck.
Please allow the Minister to reply.
——that on Monday morning an attack was launched by him on me which was rubbished by an expert from Beaumont Hospital immediately afterwards.
I criticised the Minister for failing to provide information to the patients to which they are entitled.
Please allow the Minister to reply.
I am answering the Deputy's questions seriatim. He is entitled to an answer. The Deputy fails to make the distinction between a general health warning in regard to beef on the bone, albeit a minimal, infinitesimal risk in a public safety matter, and the fact that a patientdoctor relationship exists in regard to up to 470 people.
Those people require the information.
The figure was 268 yesterday.
I am entitled to reply to the Deputy's questions.
The Minister, without interruption, please.
The primary responsibility I had in this case was not to make this issue public, as has been suggested by some, but, in the first instance, to have taken ethical, medical advice and, if that advice was to go ahead and inform these patients, to identify, notify and counsel them. Thereafter, there was an obligation on me to ensure the public was informed that this matter had been thus handled.
It has taken too long to do that. That is the problem.
Those were the steps that had to be taken if one were to abide by the medical ethics of this situation which are not being looked at with the seriousness required based on the questions the Deputy asked.
It has taken three weeks for it to creep into the public domain. That is outrageous.
Will the Minister accept that he and his Department do not seem to have learned any of the tragic lessons of the HIV infection experience and the hepatitis C scandal? The response of the Department in this instance has been miserable and ineffectual and even to this day the people who underwent those tests have not been given the information to which they are entitled. Will the Minister explain how nine days passed before the Department of Health and Children discovered, by accident rather than design, the true situation and why there is a representative of the Minister and the Department on the Irish Medicines Board? It took nine days for the Department to be informed by another source and then a further five days for the Minister to be advised.
Will he explain how such a lengthy time passed in terms of the initial phase when the Minister did not know and the second two week phase when he did not know what to do next? Does he agree that, in the same way as the beef on the bone issue was dealt with, he appears to be more keen to ape the British view on such matters?
He might also respond to a question I put to him earlier. What will he do for those people who underwent investigations and tests in Irish hospitals but who did not undergo this test and are living in anxiety and fear because they simply do not know the position? Why is it only now that he has some notion about the number of people affected? Why did he not start at the very beginning to assess and identify the people?
I do not think anybody can make sense of the point he makes in regard to ethics when it comes to identifying the number of patients who underwent tests in Irish hospitals but I have no doubt that hospitals have no problem finding these people in order to send them bills for these tests. Is it the case that the Minister had a duty to find out initially how many people were affected and to immediately provide information and access to advice for those people and others who are living without knowing where they stand irrespective of whether they had the test?
Will the Minister accept that, even at this point, he appears to be blind to the anxieties people have? Will he further accept that blood products are part of medical treatment but that the only way they can be used properly in a fashion that people can trust is if full, immediate and adequate information is presented at all times? Private sector manufacturers responded instantly and in a proper fashion and it shows up in the most negative light possible the slow, lethargic, ineffectual approach his Department has adopted in this case. It a case of obfuscation rather than information.
The Deputy dressed up a number of assertions as facts which I wish to address.
First she suggested that she cannot understand why this should be regarded as a complex ethical issue. I quote Professor William Hall, chairman of the CJD advisory committee, who is a consultant virologist in Beaumont Hospital, professor of microbiology in UCD and head of the virus reference laboratory. He states:
However, this is really a very, very complex area and it has far reaching implications both for the medical aspects, that's, both physical and psychological, and considerable ethical implications. And so we decided to spend some time, discussing this among ourselves, on how we would proceed, specifically how we would counsel these people, this is quite different from, what we had in the past with hepatitis C.
Hepatitis C was relatively simple. We could contact the people who we knew had received infectious material, we could bring them in, we could do a blood test and if it was positive, we could then counsel them appropriately on the clinical aspects of the disease and discuss what treatment options were available. Here we are dealing with material that we are not sure is infectious, we do not know if it has been transmitted, we cannot test for it. We do not know if the people were infected, how long it would take to develop the disease, 1 year, 5 years, 10 years and again the treatment options are not there.
It is really a very, very complex area, one of the most complex I have ever been involved in and so we spent the following week, discussing among ourselves. I contacted people outside the advisory committee. I contacted people both in Ireland and, in fact, in North America and discussed this and last Friday I actually sat down with the chief medical officer, Jim Kiely, in Hawkins House and we went over this finally and we decided we were going to proceed and we were going to put everything in place, including very, very good and consistently high counselling to get involvement with and advise GPs, etc. So I think there has not been a delay. I think it is an extremely complex and difficult problem. We have put the health care of the individuals as our priority and I think our approach was very solid and very thoughtful and I think in the long-term this will be of benefit, so there was not a delay, it was just a very complex procedure.
That is the answer from the head of the CJD advisory committee, who is far better placed than I am, to explain the complexity of this issue.
I spoke to the chief executive of the Irish Medicines Board in regard to the fact that a Department representative is on the board. There was no board meeting during this period and as a nonexecutive member he would not have been made aware of it. Therefore, he would not have been in a position to make me aware. I have discussed the matter at length with the chief executive and I understand precisely the scientific basis on which he was operating, that he was prioritising, as the licensing authority, the withdrawal of the product and its return to the distributors. The initial focus was to ensure the product was taken out of circulation. I have made it clear to Mr. Kelly and the Irish Medicines Board that in future, as political head of the Department, I need to be informed immediately because at the end of the day I have to answer for the IMB. I have to explain the situation on behalf of the IMB to this House. I am glad to do that, it is an exercise in accountability. I have explained that that situation is not to recur. That was an unsatisfactory aspect of the reporting mechanism and it is not to be repeated.
Our officials were informed on Thursday evening. They went to the Irish Medicines Board on Friday and got a full and detailed brief of the situation, the risk assessment, the statistical background and so forth. On Monday morning I was informed and had a comprehensive brief from my Department officials which could answer the questions I was asking. That is the reason for the delay, if one could call it a delay. It was simply a question of getting, collating and presenting the information to me in a comprehensive fashion.
It is wrong to suggest we are lethargic or that I have not got the health care of these patients as my primary focus. The contrary is the case. I can show what we have done since 27 November. On being notified on 1 December, I immediately referred this matter to the CJD advisory committee. That is my consistent approach in these matters. As Minister for Health and Children I am not qualified to make those decisions without expert advice. When the experts suggested to me on Friday, 5 December, that there were ethical issues they wanted to discuss further among themselves, with the Irish Medical Council and, as has been said by Professor Hall, eminent biologists and others further afield in North American and elsewhere——
The ethical issue is not confined to the medical profession, it applies to the general public.
——I take that seriously. For as long as I am Minister for Health and Children if there are people of that expert opinion who wish to take that time to arrive at what are major decisions——
The Minister did not allow that time to Deputy Noonan when he was on that side.
——for the people who are now about to be informed of the situation, I stand over that and I am prepared to take that advice. I see some people shaking heads. I recall when they were in the position they set up many consultative committees which took much time to deal with many issues. That suggestion was put forward by Deputy Howlin as the right way to go about it. He shakes his head when I am prepared to wait one week.
Members on the other side were not so understanding about that.
I am prepared to take valid criticism on any occasion but I am here to defend my position. If Deputies have questions I invite them to ask them. I was prepared to wait one week for those people to come to certain conclusions and to get clear, full and complete advice from the expert committee set up specifically to advise in relation to the new emerging disease. I would have thought it most inappropriate for me to do otherwise. Once I received that information on Friday, 12 December, I immediately set in train, as in the matter a week before, procedures to deal sensitively and sympathetically with this matter. The way to do that was away from the cauldron of media attention, systematically on the basis of counselling, advice and with the co-operation of consultants who have a doctor-patient relationship they wish to honour and who may have an opinion in relation to this matter. Unfortunately it became public news at six o'clock on Sunday. That made the job more difficult but it has not changed the Department's approach which is seeking to deal with the issue comprehensively, sympathetically and prudently.
I call Deputy Joe Higgins.
I am sorry——
I cannot be overruled. Will the Deputy resume her seat? I have called Deputy Higgins. If there is time we may get back to the Deputy.
The Minister promised to answer questions.
I have called Deputy Higgins.
On a point of order, the Minister has refused to answer questions.
That is not a point of order. The Deputy must resume her seat.
(Dublin West): I am happy to acknowledge that unlike the previous blood scandals, action was taken immediately by the Irish Medicines Board, though the Minister did not state categorically that not a a single patient was administered with the suspect substance after being informed. There were still 11 or 12 days when unelected people, either in the Irish Medicines Board or in his Department, were aware of this crucially sensitive and important information before they deemed it proper to pass it on to those with political responsibility. Will the Minister agree it seems officials have not learned from the previous scandals, the primary lesson being they must be accountable? It was lack of accountability that caused previous tragedies. I put it to the Minister that the most vital ethical issue is the right of each patient to know what has been administered to them. That should have been the primary concern of those who spent a week, or in some cases a number of weeks, deliberating and thinking this matter over. The 470 people were the last to know. The Minister and his officials should have known that if nine hospitals — the whole administrative apparatus — were informed it was inevitable it would leak into the public domain through the media, in the wrong way to inform 470 people who then had to rely on the media to get bits of information here and there to find out if they were involved. It is intolerable that patients became aware of it in this way. It is inevitable——
The Deputy is proceeding with a statement and that is not in order.
(Dublin West): The Minister referred to nine hospitals which have not been named.
They have been named.
(Dublin West): It would be helpful if the Minister had named them in his statement so that the people who were not involved with those nine hospitals would know they have nothing to worry about.
I acknowledge Deputy Higgins's recognition that action was taken. The nine hospitals concerned were St. Vincent's, St. James's, Crumlin, the Mater, the Meath, UCH Galway and Merlin Park — a joint operation — Cork University Hospital and Limerick Regional Hospital. I confirm that the Irish Medicines Board was notified on 18 November. The product was withdrawn from St. James's on 19 November, at St. Vincent's the product was exhausted on 14 November, in Crumlin the complement was exhausted on 13 November, the complement at the Mater was exhausted on 17 November, the product was withdrawn at the Meath Hospital on 19 November the day it was informed, UCH Galway and Merlin Park on 19 November, Cork University Hospital on 19 November and Limerick Regional Hospital on 19 November.
The Deputy said patients have a right to know. Believe it or not, patients also have a right not to know in relation to the clinical decisions taken by doctors. A person telephoned the Department today to say they did not wish to be informed. The decision was made in the United Kingdom not to inform. This is not to suggest the authorities there acted unethically. It is not a black and white issue. When one asks the medics about ethics they point out that one weighs up the benefits and the disadvantages in coming to a decision. In this case the disadvantages are obvious.
What we are talking about is half a drop of blood divided by 1/20,000 per patient. Albumin is the blood base of the product in question. There is no scientific evidence that the disease is passed through blood. Dr. Michael Brown from America who has conducted much research in this area and is an acknowledged world expert stated that the Food and Drug Administration had been advised not to withdraw the product, that the risk was regarded as minimal. I presume the same ethical standards apply. It is, therefore, a judgment call. Given the complexities involved the CJD ethics committee ruminated on the matter over the period in question and sought expert advice from around the world. It reached its decision on 12 December.
It has been suggested that a snap decision could have been taken but this flies in the face of the expert medical evidence available not alone here but in other countries. The product in question was distributed to 48 countries. There is a recall mechanism in each of these. It was not open to me to make contingency arrangements for the reason mentioned by the Deputy. If I had contacted the radiology department in each of the nine hospitals concerned immediately to have lists drawn up and was subsequently informed that, taking everything into account, people should not be informed, as happened in the United Kingdom——
(Dublin West): It is completely wrong.
That is not what happened in this case but if it had——
(Dublin West): People should know.
——it would have been leaked and questions would have been asked. It was my responsibility to deal sensitively with the health care requirements of a cohort of people who had received this product in a lung scan. I was not prepared to act until I had received advice. That was the proper, appropriate and prudent thing to do. The suggestion that I should have done otherwise not alone flies in the face of logic and common sense but the expert medical advice available to me. Everyone in the House would concede that the medical advice must take precedence. I accept the point — I made this point to Mr. Kelly of the IMB — that I have to answer for the political implications but I require the House to recognise that it was not a simple yea or nay decision.
On the BSE crisis, it was not possible to predict what effect the abnormal practices in relation to natural feeding would have. That should be a warning to us all. On the current crisis, what resources have been provided to make counselling services available? Has the Minister sought to discover the extent to which blood products sourced in Britain are used here? Are the Department and the Irish Medicines Board aware of their constituent parts, including white cells, red cells, plasma and its by-products, and the effect of each? Does the Minister plan to take measures to limit the importing of blood products from Britain and to restore public confidence in the giving and accepting of blood products?
If the Deputy tables parliamentary questions about the importation of blood products generally, I will seek to answer them comprehensively. The Deputy has highlighted one issue that will have to be addressed and considered, that is, the impact on the importation of blood products from Britain generally. It will be considered by the IMB and the Department in due course. Counselling will be provided by consultants and hospital staff.
While no one denies there were ethical issues involved in handling the matter, there were also ethical issues involved in allowing a situation develop where persons who had been exposed to a potential health risk heard about the matter on RTÉ on Sunday night. It was the Minister's responsibility to ensure a proper system was put in place to ensure people received information in an appropriate way. Adequate information and counselling services should have been made available. That was not done. It seems no action has been taken by the Minister from the time he first heard about this on 1 December up to and including today. People have still not been informed. They do not have access to proper information and counselling services. What reporting procedures have been put in place to ensure the Minister and the Department are informed immediately by the Irish Medicines Board whenever difficulties arise? This is provided for in the 1995 Act.
A question, please.
The Minister made 20 minute speeches.
What advice can the Minister give the many people who have undergone the test in question, who heard about it on Sunday night and tried desperately to ascertain information? They were desperately worried and distraught at the manner in which this information emerged and telephoned the Minister's Department yesterday and again today and encountered an answering machine. On finally establishing contact, they were informed by somebody that the Department did not know anything about it and that they had better establish contact with their hospitals. Does he agree that is a totally unacceptable response?
Deputy Shortall knows well that the purpose of Question Time is to elicit information.
What system has the Minister put in place to provide the type of information people so desperately need and deserve to have?
Does he agree his primary responsibility is to ensure the integrity of the blood supply, that confidence in it is maintained and that the basis on which that is done is by being totally open in to all matters pertaining to it? Will he say why we did not witness that openness in this case and explain why, up to half an hour ago, people could not gain access to proper or adequate information?
I dealt with this matter with the degree of openness appropriate given that there is a specified cohort of people involved who are my primary responsibility. My primary duty was not to make this public knowledge but to advise those concerned based on the advice available to me.
On people's experience in contacting my Department, I heard a radio interview this morning and apologise to the lady concerned for the manner in which her case was handled.
There were many others.
I apologise if anybody received that response. I notified the Secretary General to have arrangements put in place this afternoon to have medical personnel within my Department to deal with any queries. Medical people should deal with this issue.
While people are perfectly entitled to contact my Department and expect an adequate response, the best advice I can give them is to go to their general practitioners who will know their general medical history far more intimately than anybody in a Department of State, or contact their consultants.
The Minister gave no advice at all.
It was outlined in the Minister's speech.
The Minister did not give any advice publicly.
Deputies, please allow the Minister to reply without interruption.
Deputy Shortall asked a question and I am endeavouring to answer. In my speech I outlined what has occurred since Friday last which was the day on which the decision was taken to inform. By today we are able to state the numbers of people involved; we are able to confirm from hospitals, details of that blood supply and when it was withdrawn. We are preparing a clinical information pack which should be completed by tomorrow afternoon for forwarding to hospitals and consultants. If Deputy Shortall regards that as an inadequate response, that is her entitlement.
The Minister should not inform those concerned through this House but directly.
I ask the Minister not to answer questions put to him by way of interruption.
Since that decision was taken, the notification process which must be undertaken is being put in place. For example, there are nine hospitals and countless consultants involved in these cases who are the most appropriate people to sit down with those patients and make arrangements on the basis of a uniform information pack which will be issued to hospitals from tomorrow evening onwards.
The Minister has had two weeks in which to do that.
Can I bury that canard? I have not had two weeks to do that because a decision to inform was not taken until Friday last.
I ask Deputy Shortall to please allow the Minister conclude without interruption.
Does the Minister acknowledge that he and his Department have been unduly slow in dealing with this issue and should take that lesson for the future? Within the context of his telling us that he is not responsible for leaks to the media, would he not acknowledge that it was his responsibility to understand that inevitably something of this nature would be leaked; that it was his obligation to identify the individuals concerned and communicate with them before the relevant information was leaked but failed to do so? Can he now clarify for the benefit of the House, whenever something important comes to the knowledge of his Department on a Thursday evening, whether it is the normal approach of his Department that no one tells him until the following Monday morning? Would he not acknowledge that, once his Department had been informed of this on Thursday evening — even if a full, detailed information pack could not be provided for him the following morning — it is unacceptable that a delay of four and a half days should elapse before he is informed?
Arising out of these events, can he confirm to the House that, since receiving this product, none of its recipients has donated blood to the Blood Transfusion Service Board?
It is the practice of the BTSB that no person who has had any surgical procedure or who was admitted to hospital within the preceding 12 months can contribute to its blood pool. Therefore, anybody who was involved in this unfortunate circumstance would not be eligible to donate blood. Mindful of that fact in this case, the BTSB is reinforcing that safeguard by asking anybody who approaches them to donate blood to respond orally to the relevant question on the questionnaire, thus ensuring an accurate response. I have been in touch with the BTSB on this matter and am absolutely satisfied that is the case.
While Deputy Shatter has a view on the management of my Department I was informed by Dr. Catherine Keohane after closing time on Thursday evening last. She went to the Irish Medicines Board, got the relevant information, discussed it in detail and, in turn, informed me on Monday morning. If somebody wants to suggest that I should have been informed on Friday morning, that is all right, but I could not have done anything about it.
(Interruptions.)
An Leas-Cheann-Comhairle
Please allow the Minister to respond.
Once informed, it was my intention to refer this matter to the CJD expert committee which was to meet on 4 December so, whether I had been informed on 28 November or 1 December, I would have referred it for detailed examination to the CJD Advisory Committee which was to meet on Thursday, 4 December.
That meeting might have been convened and they might have met earlier.
That is the answer to the question. Effectively, it amounted to the same thing because my departmental officials would have been aware, in relation to the risk assessment of the Irish Medicines Board and would also have been aware, given the incubation period involved, that the first issue that had to be dealt with was the withdrawal of the product. That was the priority and was done effectively. I said openly yesterday, and repeat here today that I should prefer to know just how more effective it might have been had I been informed somewhat sooner, and made that abundantly clear to the Irish Medicines Board. Therefore, a procedure is being put in place to ensure that such circumstances will not recur and people understand my position on that matter.
The Minister needs to take charge of his Department.
Does the Minister accept that, if there was any doubt about the lethargic approach of his Department, his response today has clearly proven that through the fact that——
A question, please, Deputy McManus.
——there is no information line available within his Department for the benefit of those seeking information, the public is still dependent on media reports?
Will the Minister clearly state what is his responsibility to all those people who have not undergone this test — who do not know whether they have undergone it — since he has not declared how he will ensure that their doctors or hospitals advise them that they have not undergone this test? The Minister has refused to answer that question but rather dealt solely with those people who have had this test. Will he please clarify what line of communication will be made available so that doctors and hospitals can identify those who have undergone tests or investigations for pulmonary conditions and who may well presume they are one of those involved?
I have already answered that question. The commonsense answer is that those who have been in hospital for a lung scan or for anything to do with their lungs can contact their GP immediately who will inform them of their position through their consultant. The quickest way of getting that information is to take that proactive step oneself. It is unrealistic to expect that there is a more direct way involving an approach to the Department; it would have to do what the patient could do far more quickly.
I have told the Secretary General that I want medical personnel, from the Deputy Chief Medical Officer down, to be available to deal with queries to the Department. Many of those concerned about this matter have made arrangements to contact their GPs and their local hospital consultants to deal with this issue. I commend them on that because it is the commonsense thing to do. They are being reassured, not just from that source but by the various medical experts who have indicated in the media over the past 24 hours their assessment of the level of risk and the fact that we have taken what many others regard as an over cautious approach. If I were to be indicted on anything it would be on the fact that we are taking the most conservative approach possible to this matter. Other countries in similar situations with a far worse incidence of CJD are not taking these steps.
The Minister said yesterday that 268 persons had undergone the test in question. This figure appeared to be based on the number of vials which had been used. However, today that figure has increased to 467. Will he indicate if that is a definitive figure or will it have increased tomorrow to 600? Why is it that nobody in the Department knew how to calculate the number of people likely to have been treated?
I asked the Minister what procedures he had established to ensure that IMB would notify him immediately when difficulties arose. He said that he instructed the chief executive. Would he agree that telling the chief executive is not establishing a procedure? Is he aware that it is not simply a question of a delay in IMB notifying him, given that after eight days it only happened by chance that the Department was involved? What procedure will he establish to ensure that he is notified immediately when difficulties arise?
Deputy Shortall supported a Government which introduced the strategic management initiative and the devolution of functions to agencies. However, the culture in this country is such that if a problem arises in IMB the public will hold me responsible politically. I have made this clear to Mr. Kelly and any other agency that wishes to listen. That is the system. I do not have a problem with it.
The Minister is good at that.
This is a serious point. We all set out to strategically improve the State agencies, entailing the devolution of functions and day to day management. However, if a problem arises it comes to me, not Mr. Kelly. With regard to these matters it is crystal clear that I am to be informed immediately.
That is not a procedure.
My idea of a procedure is not to establish a joint interministerial task force to tell somebody how to do something. It is a direct order that is well understood and comprehended.
On the question of numbers, when we decided to inform as of the 12 December our task was to identify, notify and counsel. When this story broke on the "Six O'Clock News" on Sunday the Department was asked for a statement. Working from the fact that 268 vials had been used, we issued a statement to the effect that the Department understood approximately 270 patients were involved. That was based on an incorrect assumption of one patient per vial.
The identification procedure began on Monday in detail. It was only late this morning and early this afternoon that full details from the nine hospitals became available. Once it became apparent that the procedure involved in practically all of the hospitals entailed more than one patient per vial I immediately issued a statement to make that clear.
Is that the final figure?
That figure is based on information regarding the number of patients who have received the agent from the nine hospitals. We have no reason to believe that the figure will rise because the nine hospitals have identified those who received the agent. One of the nine is completing its arrangements with regard to the exact figure but I am taking the upper figure it has provided. On that basis the total figure is up to 467. It may be a little less than that. I do not expect it to increase because it is provided on the basis of full information with the exception of one hospital which is completing its analysis.