Fergus O'Dowd (Louth, Fine Gael)

It is not right that this Bill be rushed through the House when we are about to break up for the summer recess because to achieve good legislation, we need proper and adequate reflection after the Second Stage debate and on Committee, Report and Final Stages. This is one of several Bills which the Government is ramming through at the last minute before the recess. We ought to have longer sitting hours and to be here for much longer than the Government plans to tease out the issues and make proper legislation. The views of interest groups should be taken on board such as those in this case whose lives have been so appallingly affected and who have been so grievously and horribly wronged by the State. They should not be again put through the trauma, frustration and worry caused by this debate.

The Bill has come from the Department of Health and Children but Fianna Fáil cannot escape responsibility for its content because it had to be cleared by the Cabinet and discussed by the Fianna Fáil committees. There is no point in having mighty men as Fianna Fáil or Progressive Democrats backbenchers who are strong and forceful outside this House but are like poor church mice when in it. They fall silent and will not vote against this Bill which is so unacceptable to the victims of this scandal.

The Minister of State at the Department of Health and Children, Deputy Tim O'Malley, is rushing this ill-prepared legislation through. His party is locked in a power struggle over who will lead it into the next general election or whether another candidate might be an acceptable face for the party. It has lost the plot and is losing the interest of the people. The party and the Government, which no longer has a mandate, are riven with strife. They are unable to face the reality of the community and people they claim to represent.

We all learned a great deal from the hepatitis C scandal in the past but this Government has learned nothing. Once again these people are being dragged into this Chamber and their lives and trauma being thrown from one end of the House to the other by a Government which has not listened to, and will not agree with, the views they have expressed so clearly and strongly.

The Minister for Health and Children, yesterday in the Dáil and last night on the "Prime Time" programme, misrepresented the opinion and views of legal experts given to the Department. The legal opinion of John Rogers, senior counsel, has come into my possession. This opinion was given to Positive Action on the Hepatitis C Compensation Tribunal (Amendment) Bill 2006 yesterday:

The Tánaiste and Minister for Health & Children informed Dáil Éireann today that Positive Action had many years ago submitted a draft Bill to the then Minister for Health which contained a provision that a positive ELISA test be a criterion to identify persons who had been infected with Hepatitis C virus.

It appears the Tánaiste has raised this point with the purpose of demonstrating that Positive Action are misguided in their opposition to the Tánaiste's proposal to amend Section 1 of the Hepatitis C Compensation Tribunal Act, 1997 so that a person will not be diagnosed positive for Hepatitis C for the purposes of the Act unless the diagnosis is based on a positive test result arising from the enzyme-linked immunosorbent assay or the person displays symptoms of acute infection by reference to the presence of jaundice, or raised alamine animotransferase (Alt) levels, not later than sixteen weeks after the person has been administered Anti-D.

The reference to enzyme-linked immunosorbent assay is a reference to the ELISA test.

I understand separately that there are new amendments before the House today in regard to other tests, with which Deputy Twomey will deal on Committee Stage. The legal opinion continues:

The proposed amendment means that a person would not be entitled to succeed in a claim for compensation before the Compensation Tribunal unless that person could show they had had a positive ELISA Test or that they had had jaundice or raised Alt levels during the sixteen weeks after the person had been administered Anti-D.

There is a real danger that to exclude a person who cannot show a positive ELISA Test will give rise to injustice. There have been cases before the Tribunal since 1997 in which the issue of the adequacy of the ELISA Test as a diagnostic tool has arisen. For instance in a case which I will refer to as "C" which was heard by the Compensation Tribunal on the 2nd of December 1998 Doctor Graham Foster, consultant hepatologist, who was giving evidence on behalf of the applicant, was asked by Counsel:

"Again looking at what we would call the antibody tests and we have been through a range of them here; one is the Ortho and the other is the ELISA and we have had many of them over the period. Can you assist the Tribunal as to what a positive or a negative antibody test means?"

To this question Doctor Foster answered:

"I think again it is a question of level and cut off. What happens in the simple ELISA is that patient's serum are allowed to bind to Hepatitis C proteins and the level of binding is then assessed. Whether that is positive or negative depends on a cut-off value and the cut-off value is defined at the level at which the vast majority of people who have active Hepatitis C have a number greater than that, and the vast majority of people who do not have active Hepatitis C are lower than that. So, there is clearly a fixed cut-off level.

Again to say there is no antibody present simply means that in this individual the level of antibody is less than that found in the majority of patients who have active Hepatitis C. Again to extrapolate from that, I would argue that in patients who have been exposed to the virus, there may well be low levels of antibody that don't reach the level of the cut-off in the standard tests."

It is noteworthy that in the "C" case in which Doctor Foster was giving evidence the Tribunal relied on a clinical diagnosis and found that:

"The tests as have been carried out since the 1990s have been inconclusive but we are satisfied that she was exposed to the virus".

The Finlay Report was submitted to the Minister for Health in March 1997.

It is noteworthy that Mr Justice Finlay appended to his report the answers to certain questions that had been submitted by him to the Blood Transfusion Service Board and the answers to these questions are found at Appendix G. The first question was:

(A) How many persons were infected with HCV as a result of receiving the 1977 infected anti-D?

The answer given was to the effect that 704 persons who received the 1977 infected anti-D showed evidence of past or current infection on a laboratory screening. It was stated a further 53 show a RIBA reaction in which HCV antibodies were not confirmed but which the BTSB then thought was either evidence of cleared infection or falsely positive reactions. The BTSB said this would require further study.

What is important is that the BTSB were then careful to qualify their observations in relation to the number of persons who are infected by saying:

"However, we now have evidence that it is also possible (although apparently rare) for a person to be infected and subsequently lose both detectable virus and indeed detectable antibodies. This happened in the case of donor Y. While we have no laboratory means of identifying these persons, we have, however, taken a history of symptoms or signs from those who received BTSB anti-D. We are thus aware of 74 recipients of 1977 anti-D who had an episode of jaundice at that time which is most likely to be related to exposure to Hepatitis C. As these persons do not show any reaction on laboratory tests for Hepatitis C an epidemiological study is planned to investigate transient infection which has subsequently cleared."

It is clear from this that the BTSB itself was not happy about reliance upon the screening tests such as ELISA. Further, the fact that the infection of some persons was detectable by virtue of they having experienced an episode of jaundice clearly shows that clinical diagnosis is a valid method by which to determine whether a person has been infected with Hepatitis C.

The draft Bill to which the Tánaiste referred this morning [and again last night on "Prime Time"] was prepared and submitted by Positive Action to the then Minister for Health in September 1995 which was before the Finlay Report and before it was known to Positive Action and their advisers that there was "evidence that it is also possible (although apparently rare) for a person to be infected and subsequently lose both detectable virus and indeed detectable antibodies".

This position as advised by the BTSB to Mr Justice Finlay was confirmed later by the evidence of gastroenterologists and hepatologists before the Compensation Tribunal and I point particularly to the evidence of Doctor Foster when he said "there may well be low levels of antibody that don't reach the level of the cut-off in the standard tests".

In short, the Tanaiste appears today [yesterday] to have relied on a draft Bill prepared for Positive Action and submitted by them to the then Minister for Health in September 1995 long before the Finlay Report made it clear that there were anti-D recipients who had suffered virus infection who lost both detectable virus and indeed detectable antibodies but in respect of whom clinical diagnosis was capable of confirming infection had in fact occurred.

Should further clarification be required I will be available.

John Rogers.

The issue is very clear. The reality is that the Minister for Health and Children, the Department of Health and Children and the Government have got it entirely wrong. It is clear that the families in question have been absolutely wronged by the Government's actions. The Government backbenchers who are making so much noise about this issue clearly will not vote against this Bill because they do not have the guts to do so. They cannot be in opposition and in government at the same time. I challenge the sweet 16, who are mighty men in the press and church mice in the Dáil, to vote with the Opposition to remove the amendments which are unacceptable to the victims of infection.

A human tragedy of vast proportions, which has destroyed lives and families, is central to this issue. It is unacceptable that the Government, rather than supporting all those who are condemned to a life of worry about their health, is trying to exclude some of them from this scheme. That is what will happen, however, if we rely on a single test and ignore the evidence of other tests, which is that more people might be entitled to make a claim. The Government wasted over €50 million of taxpayers' money on voting machines and further millions on PPARS. It is spending money here, there and everywhere. There is great concern at the heart of our society that the victims of this scandal should be properly and adequately compensated. Perhaps "adequately" is the wrong word to use because the people in question can never be compensated for the wrong that was done to them. They should not have to endure this trauma and worry.

Given that she has been in the Oireachtas for over 25 years, the Minister for Health and Children should know much better. The Government, which has been in power for 18 of the past 20 years, is rushing bad legislation through the Dáil today. It is unacceptable that it is continuing to make the victims of this scandal suffer as a result of the scourge of its inactivity and its lack of care, sensitivity and concern for the needs and feelings of the victims and their families. The country is united in its conviction that this legislation needs to be changed today. The Government must meet the needs of the families in question. It has shown a shameful disregard for people who are really suffering at the hands of the State. If any money should be spent and concern should be shown, it should be shown for the people to whom I refer. It is obvious that no money will meet all the needs of the victims and their families, who will continue to suffer. It is not a question of compensating the victims for what has happened, but of helping to meet some of their needs and alleviate some of their worries. The money will be helpful for their families in the future, after they have passed on. The Minister of State has a few hours to decide to make some changes to this legislation. The Government and its backbenchers need to get their act together. It will not be acceptable if they get away with this.

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