Anti-D Immunisation: Statements.

Minister for Health (Mr. Howlin)

The Blood Transfusion Service Board informed me on Thursday, 17 February 1994 that evidence had emerged that there was a possible link between the product anti-D immunoglobulin and hepatitis C. The Blood Transfusion Service Board made arrangements to change the product and this took place the following day, Friday, 18 February 1994. The board has introduced a new virally inactivated product which has been supplied to hospitals.

Rhesus haemolytic disease of the newborn is a condition that affects Rh positive babies born to Rh negative women who have developed anti-bodies to the Rhesus factor. These anti-bodies generally do not affect the first pregnancy but develop in subsequent pregnancies. The mother's anti-bodies cross the placenta while the baby is still in the womb and begin to destroy the baby's red cells. The baby can be thus affected by anaemia, brain damage or may be stillborn. Over 100 babies a year in Ireland were lost as a result of this condition. Others, less severly affected, required treatment by exchange transfusions.

In the late 1960s, it was discovered that the development of these harmful anti-bodies in the mother could be prevented by the administration of a substance called anti-D immunoglobulin. A national programme for the production of this vital substance was initiated in 1969 and has been dramatically successful in preventing the condition with now fewer than five babies per year being severely affected.

The hepatitis C virus was first described in 1989. Infection with hepatitis C may cause jaundice immediately. More usually the infected person is totally unaware of infection. In some cases, however, the virus may persist and cause chronic inflammation of the liver.

The question of introducing a screening test for hepatitis C for donations nationally had been considered in 1989 and 1990. During this period the Blood Transfusion Service Board and the Department of Health examined the possibility of introducing such a test. However, a review of international practices and discussions with medical experts abroad revealed that there was insufficient scientific information about the test to approve its routine introduction. The position was carefully monitored and when the test was considered sufficiently reliable for the purposes of screening donations, it was introduced in Ireland. This occured in 1991 at the same time as this screening was introduced in the UK. I emphasise that cost is not a factor in the timing of the introduction of such tests and, in fact, £1 million for hepatitis C testing by the Blood Transfusion Service Board has been approved to date.

In January 1994, as part of the ongoing monitoring of quality assurance procedures by the Blood Transfusion Service Board, it emerged that a disproportionate number of group Rh negative female donors had anti-bodies for hepatitis C. On further investigation it was found that nine of the ten female Rh negative donors had received anti-D in 1977. This was linked with an earlier report of six cases of jaundice which had been investigated in 1977 when no cause for the jaundice had been found. It would seem that the anti-D manufactured in 1977 is potentially the cause of this problem.

I commend the Blood Transfusion Service Board for carrying out this very thorough research which is essential in the monitoring and quality control of blood products which it produces.

When this matter was brought to my attention, my immediate concerns were: (i) the protection of all future recipients of anti-D immunoglobulin and (ii) the identification of any risk, however small, for any mothers who received the anti-D immunoglobulin product in the past. I agree, therefore, that the action taken yesterday by the Blood Transfusion Service Board was correct as the safety of blood products must be the first priority at all times.

The Blood Transfusion Service Board has announced its intention to follow up all of the mothers who may have been at risk of contracting hepatitis C from the anti-D immunoglobulin product. A special public awareness campaign has been launched to inform the public as to the possible risks.

Special arrangements have been made to provide information to general practitioners who, in many cases, will be the first point of contact for the women concerned. Free telephone lines have also been put in place by the Blood Transfusion Service Board to provide information to people who might be anxious as to whether they are in the category of those who might be at risk. The phone lines are open from 9 a.m. to 5 p.m. each weekday beginning today Tuesday, 22 February 1994.

Special arrangements for testing of women at risk have been made at the following locations throughout the country: Dublin, Galway, Limerick, Cork, Waterford, Drogheda, Sligo, Tullamore, Clonmel, Killarney, Letterkenny, and Cavan. Blood testing at the Blood Transfusion Service Boards centres and at general practitioners surgeries will be administered free of charge.

I am determined that every woman at risk will, as far as practicable, be indentified. The BTSB is making specific arrangements to trace the cohort of mothers who were given the anti-D products in 1977 and are focusing on these mothers. Because of changes of addresses it may not be possible to trace everybody and thus the public awareness campaign has been launched. Because we cannot be sure that the problem is confined to 1977, the Blood Transfusion Service Board is advising any woman who has received anti-D to be tested. Decisions on the individual follow-up necessary will be made as a result of the ongoing testing process.

It is accepted that all medical interventions, including the use of blood and blood products, carry some risks which require the balancing of the benefits and risks of particular treatments. I would like to reassure the public that there is no need for alarm. The Blood Transfusion Service Board has taken action to ensure the safety of blood and blood products as far as possible. The prevalence of hepatitis C in Ireland among blood donors is low and compares favourably with other European countries. This implies that hepatitis C is not widespread in the population.

It is estimated that approximately 100,000 women require testing, which will be provided within as short a time frame as possible.

If any of the people give anti-D immunoglobulin need medical treatment for hepatitis C as a result of receiving this product, I confirm that whatever treatment is prescribed by the clinicians will be provided by the public hospital services free of charge.

Mrs. Owen

The announcement from the Blood Transfusion Board that many women may have been contaminated with hepatitis C following treatment with anti-D immunoglobulin in the 1970s has sent shock waves among mothers of children of 14 years and over. Although the announcement refers specifically to administration of this substance in 1977, it is not clear whether women who had this treatment between 1970 and 1990, when hepatitis C was identified, should also be concerned and need checking. I am glad the Minister implied they will because I got a call this morning informing me that women who had babies in 1974 and 1975 were told on the help line that they need not be concerned and did not need to be tested.

Now that this information is available, the responsibility falls on the Minister for Health to ensure that every woman who may have been affected is contacted and tested as quickly as possible. I realise this is an enormous task but it is essential that all resources be mobilised to carry it out. It is necessary that the Minister clarify what actions have already been taken through hospital and general practitioner records to indentify the relevant mothers. It will also be essential to contact all adoption agencies in an effort to identify mothers who gave their babies for adoption. It will be essential to identify mothers who may have miscarried but may also have received the anti-D injection after such miscarriage and may not have been recorded. It is essential that groups working for sections of our society, such as travelling mothers, would assist in identifying mothers in that community whose addresses may not be readily available from hospital records or who may have changed their place of residence many times since the birth of their children in the 1970s.

When a woman is shown to be infected, what treatment will she get and where will it be carried out? Can this infection be passed on genetically to offspring or sexually transmitted? The Minister has not answered these questions and they must be answered.

I understand that many women have already received postcards in this morning's post telling them to go to their GP's clinics. Will the Minister clarify how this group was identified? I am disturbed by the fact that GPs were not immediately notified about how to deal with their patients when this information became known last week, particularly as it was clear that when a woman received a notice to attend her GP she would go immediately. This morning I spoke to a number of doctors who told me they were unable to handle queries or to give information other than what was contained in newspaper articles. The doctors themselves received nothing in their post about this issue.

Another area of concern is that some of these women have been blood donors, particularly before 1991. We are told that since 1991 all blood has been screened for hepatitis C. What is the position with regard to blood taken before this screening process came into use? Added to the concern of one woman who was in touch with me today that she might have hepatitus C is the concern that she may have given blood which, in turn, might have contaminated somebody else. It is important that this additional worry is not added to the trauma already felt.

Can the Minister say definitively that all risk of infection has fully disappeared since 1991 or is there still a risk for mothers receiving the anti-D injection today? I do not wish to be alarmist or add to the fears of some women and their families. However, it is important that the openness and transparency the Minister promised is continued.

I am reminded by this instance of a time in the early 1980s when I received information about the possibility that blood donations could be contaminated by the AIDS virus and haemophiliacs suffering as a result. I was wrongly criticised by the Blood Transfusion Service Board and others for being alarmist. Sadly, less than a year after that information was available my concerns became a reality. Now we know that many people contracted the AIDS virus through contaminated blood. I recognise the excellent work being done by the Blood Transfusion Service Board. At the same time problems arise and I want to ensure that this problem is dealt with fully and openly.

From the information in the newspapers today it is clear that knowledge of this contamination was available some time ago, although there may not have been proof. Clearly, research in Munster showed that earlier this year women who had babies in 1977 were identified as having hepatitis C. Why was the alarm not raised then and mothers of children born in 1977 contacted? A satisfactory answer has not yet been given for the apparent gap in making the knowledge public.

In regard to the broader issue of medical information being made available to patients in general, one of the problems that will arise is the lack of real information and whether mothers will remember if they received the injection, or any other treatment, during their pregnancies. I do not remember what treatment I received during my pregnancies. I urge the Minister to use this opportunity to examine ways in which more medical data can be made available, as of right, to people in hospital and patients generally. Surely it must be possible to provide a card to patients leaving hospital identifying the drugs or any special treatment they received so that if questions arise in the future it will be easy to contact the relevant people.

It is crucial that there is no underestimation of the trauma this disclosure will cause to thousands of families, not just on the mothers affected. I know the Minister shares my sense of urgency in identifying and treating the affected women.

Mr. Cullen

As other Members stated, there is no doubt that many thousands of women are deeply concerned and confused about the information received in the past 24 hours. Many women have told me they cannot remember exactly what treatment they received when pregnant. They can remember being put on a drip or receiving injections but are unaware of what those injections were for. Therefore, if it can be easily established that a woman did not receive an anti-D injection during her pregnancy and she returns to her GP or hospital, she should be examined and assured she is absolutely safe. The Minister should make the net a little wider.

In relation to the hepatitis C alert affecting more than 100,000 mothers who received the anti-D treatment since the early 1970s, the first key question to be answered is why it has taken from 1989, when the virus was discovered, and more specifically from 1991 — when the Blood Transfusion board learned of a link between the virus and the anti-D treatment — to alert the women concerned. The Minister stated he was only informed of the matter last week. Was the Minister's predecessor or officials of his Department aware of it before then? The length of time which elapsed before making the knowledge available at least to the medical community, if not to the patients concerned, is unacceptable. The Minister did not clarify the reason for such a gap or why the information has suddenly been made available. There are many questions in that regard which need to be answered and lessons could be learned.

Were all those involved in health care, notably surgeons, doctors, nurses and other specialists, notified of the link at that time and if not why? Who is responsible for the procedures in this area? Is it the Minister, the Blood Transfusion Board or individual hospitals? Have all the stocks of the anti-D treatment used here since its introduction been exclusively home produced or were imported batches used? If imported stocks were used, have they been identified, when were they imported and from where did they come?

What is the risk of developing hepatitis C from contaminated blood or blood products? I understand four outcomes can arise from such an infection, two of which the Minister referred to. Some people may have already contacted hepatitis C but are unaware of it because their immune systems have overcome it. People will have developed jaundice, but no further serious symptoms and are unlikely to do so. Others will have developed chronic hepatitis — ongoing inflammation of the liver — which can lead to sclerosis and ultimately death and the one which will give rise to most concern. I do not wish to be alarmist, but people have already died from the infection. I would like the Minister to clarify the figure in respect of the number of people who received the contaminated anti-D treatment and as a result contracted hepatitis C. Does the Minister know the percentage involved?

This matter highlights the importance of tracing and identifying all women who received the anti-D treatment and establishing whether it is possible to do so. The Minister stated that the relevant people are being contacted. Apart from a public awareness campaign, is the Blood Transfusion Board systematically going through all records to identify the people involved and writing directly to them? There was some confusion earlier in that regard but the Minister clarified the matter to some extent. I take it that there are records of the people involved. I understand it is mandatory to keep a record of all people who receive blood or blood products, not because they may have received contaminated products but because they may develop an allergic reaction to non-compatible blood or blood products. In other words, records must be available. Therefore, there is no reason to suggest there would not be records of the women who received the anti-D treatment. We need clarify from the Minister on the risks of developing hepatitis C from contaminated blood or blood products.

Can this disease be sexually transmitted? The Minister and officials of his Department should consider the matter of compensation now so that they are not forced, kicking and screaming, to deal with the issue at a later date. The matter of compensation should be made clear at this stage. As people desperately need reassurance in regard to this matter, speedy action on all fronts in respect of contacting all those affected is vital.

What information is available on the screening of health care workers in general? What percentage of health care workers dealing with blood products and at risk have been tested for hepatitis? Is it Department policy that people at risk working in the health area are vaccinated against hepatitis? I understand that a surgeon with hepatitis is not allowed operate in the United Kingdom. Directives in this regard have been issued during the past 12 months. Have those directives been adopted here? Will the Minister indicate his Department's views in respect of measures to ensure that our general care workers who provide treatment have good health?

Ms McManus

I thank the Minister for allowing us the opportunity to make statements. He decided yesterday to raise this issue through the media and, by doing so, has highlighted the need for screening. This is a matter of great concern to everybody, particularly the large number of women directly affected. The Minister's decision to raise this issue has heightened the level of anxiety among women. Why did he not adopt the approach many people, particularly those working in the health care area, would have expected, namely, to inform those who will have to carry out the testing, screening and give advice? In particular, I refer to general practitioners. Most general practitioners were unaware that this matter was about to explode in the media. Information landed on most of their desks today. I accept an effort was made to communicate with all general practitioners, but some did not receive the information before it was highlighted through the media. Hepatitis C is not a common condition and it is a newly discovered one. General practitioners were put in the invidious position of having to answer questions even though they had not been fully informed of the answers. I wonder if the Minister could have prepared the ground before going public on this issue. It would not have taken a long time and it would have been helpful to engage in consultation with health care deliverers namely, hospital staff and doctors around the country, before he went public.

From an organisational point of view the first 24 hours is vital in a project like this. It is unfortunate that those 24 hours have been marked by confusion and lack of information. I accept the Minister has put in place information systems, but there has been an overloading of systems and people are not always available to answer questions. People have had difficulty getting through on the telephone lines and as a result have not been able to have their anxieties allayed. I appreciate the Minister does not have the gift of prophecy, but surely this type of response could have been anticipated. I am aware that the Irish College of General Practitioners was contacted earlier but it was short notice and family doctors as a whole did not receive the information until today at the earliest.

Other questions arise which the Minister has answered in part. We need a comprehensive report as to why there were timelags, particularly between the discovery of the necessity for hepatitis C screening and its implementation. Decisions were made which have major implications for the health of the women involved. I accept the Minister is willing to provide as much information as possible. We need the full story in regard to the timelag involved.

I appreciate it is easy to talk from the position of hindsight. Why were the cases in 1977 not followed up in the light of the information that came on stream in 1989? The safety of the anti-D product was questionable. A link between the condition and the product was known in 1991. It is now 1994. During that intervening period it is not clear if women were informed as to the potential risk of the product. I would like the Minister to comment on that.

I am concerned that the high profile media campaign is a blunt way to approach this matter. No matter how well organised the campaign is it will not reach everybody. Women moving around who may be out of the country and who do not normally follow what is happening in the media will fall through the system. Those people would be more likely to come forward as a result of a focus on the Blood Transfusion Service Board's records mentioned by the Minister. It is important that all women are informed about this matter. Just because politicians are discussing this matter it does not follow that all women who are at risk will get the message. It is an achievement for any woman to recall what happened during childbirth in the seventies. I am concerned there is a focus on women delivering babies during that period when a person who had a stillbirth or a miscarriage is equally at risk. That matter needs clarification. It is also possible that males and females could have contacted hepatitis C from blood transfusions. The Minister and the Blood Transfusion Service board need to clarify this matter. While the risk is small it exists and needs clarification.

The information about the various forms of hepatitis is only emerging. Doctors know there is hepatitis A, B, C and D and many expect there will be other viruses implicated in hepatitis in the future. What assurance can the Minister give that blood and blood products are treated in such a way as to ensure, even if there are, as of yet, undetectable viruses present in the blood, that the blood is treated to ensure they are killed and consequently cannot be passed on to a recipient?

It is important that the population's trust in our excellent national Blood Transfusion Service Board, which is the envy of Europe, is maintained and all possible measures are taken to ensure this occurs.

The Minister is right to have full disclosure. He might have been advised to provide for it on a phased basis by consulting with the practitioners in the first instance. It is a sound principle to make information as publicly available as possible. The Minister recognises we have a mature and sensible population. It is important that information be available to avoid panic. There should be consultation as to how information in respect of other questions raised, and not answered today, is to be disseminated. Apart from any media campaign the Minister has embarked on, it is important that he uses the information which may be accessed from hospital records and GMS records to track down the women involved. He should not overestimate the capability of the media to reach those women. It is more effective for hospital staff and doctors to be in a position to locate and advise their patients of the need to come forward for screening.

There may be cases where it is not possible for the Minister's Department to locate some woman involved. Attention must be focused on such women. For example, we must focus on members of the travelling community who move around the country and who do not have GMS cards.

Mr. Howlin

I am anxious to provide as much information to Deputies and the House as I can. I said yesterday that I want to characterise this campaign with openness and by providing access to information I hope there will be a calm but thorough approach to this matter. I do not want to leave anything undone in terms of identifying any possible risk. At the same time I do not want people to be unduly alarmed. I listened very carefully to all the points raised by Deputies opposite and I will do my best to respond to them. I will restate the offer I made of a full briefing on the matter from the officials of my Department, the Blood Transfusion Service Board and outside experts. Until the end of last week I did not know very much about anti-D immunoglobulin and I do not pretend that over the weekend I have become an expert in it. I am not the person to answer all the questions but I will provide the expertise to Members of the House to answer any question that may be raised in the context of reassuring every woman in the country.

I accept the argument put forward by some Deputies that the campaign I authorised, which was proposed by the Blood Transfusion Service Board, is a blunt campaign. From the moment I heard about the problem I believed it was important to achieve two objectives. First I wanted to ensure that women would safely receive anti-D immunoglobulin — that was done by importing last Friday a product that is virally inactivated. Second, I sought to begin a process of indentification. Some Deputies opposite said I should have first notified or communicated with all general practitioners, but it would have been impossible to do so without giving rise to tremendous fears across the community. If I did so, I would have had to answer questions in the House from Deputies opposite as to why doctors were alerted while women who potentially might be at risk were not notified. I agreed with the decision of the Blood Transfusion Service Board immediately to alert women that this potential problem exists and to provide free telephone lines and information to all general practitioners. With the co-operation of the Irish College of General Practitioners, information was sent to all general practitioners yesterday and they should have had information today.

Mrs. Owen

The postal service in Malahide must be very bad.

Mr. Howlin

I am not responsible for An Post, but it is very important that doctors have information — obviously many of them will be well briefed already on hepatitis C. If general practitioners do not have the information already, they will have it in a day or two. I do not want to see anybody panicking about anti-D immunoglobulin. Some women will have had this treatment ten or 15 years ago and they need not panic now. We have put in place 12 testing centres across the country and up to 6,000 samples per day will be tested. Our ambition is that all women will be tested within the next couple of weeks.

On the question of responsibility to contact every woman, I have outlined what we are doing in this regard. We have put in place a national media campaign and a huge number of women may be contacted through the media. Information lines are very active in dealing with queries on the matter and I hope people will be calmed by receiving accurate information immediately. Those who go to their general practitioners will be tested free of charge and the fears of the vast majority of women will be allayed when they find that results of tests are negative. The identified cohort from 1977 has been contacted — we have written to 4,300 of the 6,000 women involved and we are doing our best to identify the remaining women.

As regards the passing on of the disease, I will leave it to the experts to brief Deputies on the minutiae of the technicalities of passing on the disease. I am not in a position to answer all the questions in that regard and it would be safer to leave it to the medical experts. I will provide that information to Deputies as soon as it is available.

Clearly hepatitis C existed prior to its identification in 1989. Tests in 1991 found that 0.03 per cent of donations, or three cases per 10,000, are affected. Therefore there is a very low incidence of the virus in the donor population, lower than the European norm. The virus also existed prior to testing and a categoric assurance cannot be given that it could not be contracted by way of blood transfusion. However, I wish to clearly state that it is a virus that is not readily transmitted by way of blood transfusion.

I became alarmed when I heard about this matter on Thursday last. I commend the tremendous hard work and diligence of my departmental staff and the Blood Transfusion Service Board who, from the moment the problem was recognised, put in place a very successful public awareness campaign which, once people are given the information and are tested, will build confidence, which is very important. As Deputies opposite have said, we are very fortunate to have a blood transfusion service that is the envy of Europe and I am most anxious that that position be maintained.

In relation to the gap in notification of the problem, the accurate test became available in 1991 and it was introduced here at the same time as in the United Kingdom — both countries accepted that there was a reliable test available. Experts have told us over the weekend that there is no discernible increase in hepatitis C in the population. Therefore there is no pool of infection about which we should be very alarmed.

Deputy Cullen raised the question of imported anti-D immunoglobulin. None of this product was imported up to last Friday. The new virally inactivated product, which ensures safety, was imported from Canada during the weekend. Health workers are not routinely screened for hepatitis C. The incidence of the virus is so low in the population that it is not believed to be a risk.

Mr. Cullen

I was talking about hepatitis in general.

Mr. Howlin

On foot of the question I will undertake to review the matter to see if there is a need for such screening. I accept the comment in relation to a proactive role by the Blood Transfusion Service Board. That board has been magnificently proactive. Its spokespersons have been very clear and strong on television and radio in the last 24 hours and I hope that will continue.

Mrs Owen

The Minister did not refer to adoption agencies and travelling women.

Mr. Howlin

My intention is to contact everybody who might be at risk. If there is a specific need to reach out to any group that might not be contactable through normal media or postal resources, I will discuss the matter with the Blood Transfusion Service Board to see what plans it has in that regard.

Deputy McManus asked if I could give a blanket assurance that no other virus will be passed on by way of blood treatments. In her previous contribution, the Deputy said I do not have the gift of prophecy, but I would need the gift of prophecy to give such an assurance. I could not address that issue with absolute certainty. We have a blood transfusion service that is the envy of Europe. It has a tremendous record of service and has provided a huge life-giving resource to millions of Irish people in the course of its lifetime. The board is determined, as I am, to ensure that that fine reputation is preserved, and that will be done in a completely open way so that people's anxieties are allayed.

Mr. Allen

May we ask one question?

An Ceann Comhairle

The Minister has indicated that he will make himself available to Members of this House in respect of advice, guidance and elucidation generally of this subject. The debate concludes now. I am proceeding to item No. 2, Extradition (Amendment) Bill, 1994——

Dáil Éireann debate - Tuesday, 22 Feb 1994

Anti-D Immunisation: Statements.

Dáil Éireann debate -
Tuesday, 22 Feb 1994