Hepatitis C Compensation Tribunal (Amendment) Bill 2006: Second Stage (Resumed).

The following motion was moved by the Tánaiste and Minister for Health and Children today:

That the Bill be now read a Second Time.

Debate resumed on amendment No. 1:

To delete all words after "That" and substitute the following:

"Having regard to the fact that the Bill contains matters unrelated to the issues that were the subject of extensive discussions with interest groups representing affected persons and the additional matter adversely affects the interests of those persons and having regard also to the failure of the Minister for Health and Children to publish an explanatory memorandum outlining her reasons for including the additional matter, Dáil Éireann declines to give a second reading to the Bill.".

—(Deputy McManus).

Mr. Callely

I am grateful for the opportunity to speak on this Bill. I offer my congratulations to the Irish Haemophilia Society, the Irish Kidney Association, Positive Action and Transfusion Positive on their excellent work in representing their members and keeping this issue to the fore over many years. I understand that the Bill will establish a statutory scheme to address the insurance difficulties experienced by persons infected with hepatitis C and HIV through blood products administered by the State.

Unfortunately, most people in this country are familiar with hepatitis C because of the many thousands of unfortunate people infected following the administration of contaminated blood and blood products through the Irish Blood Transfusion Board.

We understand that hepatitis C can vary in severity. A person can suffer from acute hepatitis C, where there is a rapid onset of the disease, or chronic hepatitis C, where the onset is gradual but will be of long duration. The main means of contracting hepatitis C is through contaminated blood, which is how the people we are discussing were infected. The disease can also be passed from mother to baby.

The real tragedy of hepatitis C and HIV lies in the fact that there is no vaccine or cure for them at the moment. Those affected must live out their lives in the shadow of chronic diseases and are likely to require long-term medical care. The Bill addresses three elements in an attempt to alleviate hardship. These elements are compensation, the special health card and life assurance support. I understand that adequate funding for the scheme will be made available by the Exchequer for approximately 30 years.

The supports currently available to those infected consist of the hepatitis C and HIV compensation tribunal and the Health (Amendment) Act, which provides for a range of free health care services. The compensation tribunal was established in 1995 to compensate those infected and became a statutory body with the enactment of the Hepatitis C Compensation Tribunal Acts of 1997 and 2002, which make provision for compensation to those infected by HIV as a result of receiving a relevant blood product. I understand that the State has already paid out over €250 million in compensation to over 1,300 women infected with hepatitis C and that the final payment is expected to top €500 million.

However, these are mere figures which cannot calculate the devastation caused to these women and their families following their infection. The Health (Amendment) Act Card entitles those affected to general practitioner, nursing and home help services, as well as counselling services for them and their families, regardless of income. Prescribed drugs, medicines and medical and surgical aids and appliances are also available. Those affected are entitled to these services for life.

There is no suggestion that any amount of money, the required supports or services to which I just referred or any other form of compensation can ever make up for the suffering inflicted on those people who were infected with HIV or hepatitis C because they received contaminated blood or blood products from this State. It is hoped that this Bill, while long overdue, has the potential to provide the necessary answers and supports sought by sufferers and the relevant advocacy groups.

The inability of sufferers to buy life assurance, mortgage protection policies or travel insurance has added to the hardship experienced by them and their families. This issue of insurance was highlighted by advocacy groups and the consultative council on hepatitis C as far back as 1997. The Department of Health and Children initially sought advice from the insurance industry, while also consulting with advocacy groups on solutions to the problem. I understand that there are two separate issues for people with hepatitis C and HIV regarding insurance. Certain people can only obtain insurance with increased premiums, while others are deemed uninsurable by the insurance industry. The Government has proposed to deal with the problem by paying the additional risk premium where the insurance provider is willing to provide cover, subject to an additional premium. Where no assurance is available, the State will assume the risk on the life cover. In each case, the person requiring insurance will pay the average basic premium which an uninfected person of the same age and gender would pay. This effectively evens the playing field for those with hepatitis C and HIV.

It is a matter of grave concern that groups representing haemophiliacs infected with hepatitis C and HIV through State-administered contaminated blood products are not completely happy with the content of this Bill. Before I entered the Dáil at 5.36 p.m., I received a memorandum from one of the advocacy groups which makes three points. The first is that in its communications over several years, the group always believed that this Bill would be stand-alone legislation and that there was never any question of linking it to any other scheme or mechanism. The group argues that the changes mean some of its members and some members of other advocacy groups will be disenfranchised and prevented from taking part in the compensation scheme. The group's second point is that subsections (a) and (b) of section 1 and sections 2 and 6 should be deleted and that if this were done, all the advocacy groups would endorse the Bill. The group’s third point is that the advocacy groups are happy to engage in discussions with the Department to address any changes that may be required to the hepatitis C compensation scheme.

I am known as a person who likes to deliver, achieve results and ensure that measures are all-inclusive. I am surprised that we have travelled this road and are in possession of this legislation but are still receiving communications of this nature at this late stage from people who honestly and in good faith engaged in discussions to achieve satisfactory results but who are not satisfied with the legislation at the eleventh or twelfth hour. This situation is completely unsatisfactory. I urge the Minister to give due consideration to the concerns set out in the fax I received and other concerns voiced by groups representing those who have been infected. They have waited long enough for their needs to be met. They were infected because of errors in the use of blood products by State agencies. I am surprised we find ourselves in this situation. We should do all we can to address their concerns.

I understand that the Irish Haemophilia Society, the Irish Kidney Association, Positive Action and Transfusion Positive all oppose the Bill, which introduces a new scientific definition for hepatitis C that is used in other jurisdictions. Such a definition can be used but we should also examine the situation in this jurisdiction and work with these groups to secure agreement. The Bill specifies that the person has not been diagnosed positive for hepatitis C for the purposes of the Act unless the diagnosis is based on a positive ELISA test or if the person has displayed symptoms of acute infection such as jaundice or raised ALT levels within 16 weeks after the administration of the anti-D blood product. The advocacy groups contend that this definition will exclude a number of haemophiliacs who were treated with infected blood and who have displayed medical symptoms of hepatitis C but who have as yet not tested positive for the disease. I understand that the advocacy groups are also critical of an amendment to the Hepatitis C Compensation Tribunal Act 2002 which restricts the entitlement of some spouses and partners of hepatitis C sufferers to claim compensation.

This Bill is designed to acknowledge the rights and meet the entitlements of those who contracted hepatitis C and HIV from blood products provide by the State. If the Bill is not effective in doing so, we must re-examine its content. I believe that amendments will be made to this Bill before it is enacted. While I acknowledge that the provisions in the Bill regarding the definition of hepatitis C bring Ireland in line with other jurisdictions where compensation schemes operate, we as public representatives must be satisfied that we have done all we can to deal adequately with the consequences of the infection of people through State-administered blood products. Those who contracted hepatitis C and HIV as a result of contaminated blood products have a basic entitlement to life assurance and mortgage and travel insurance in line with the rest of the population. It is not acceptable that they are discriminated against because of their health problems and it is up to the Government and the House to ensure they are treated equitably and with dignity. This means that those who were infected should be able to obtain insurance cover in line with the rest of the populace.

This is an urgent matter and those who were infected should not find themselves in this position or wait any longer. We must ensure that the Bill addresses all their concerns. I earnestly ask the House to unite and ensure the passage of appropriate legislation. It is my understanding that the people involved in the discussions, particularly the advocacy groups, clearly put forward their case during the months and years preceding the Bill's introduction to the House. Most Deputies are anxious to ensure that their desires are met. Therefore, I do not understand why we cannot proceed in the most appropriate fashion to get the best result for the people seeking our support and assistance on this issue. I look forward to the developments that will hopefully take place on this proposal during the coming hours.

Ms Lynch

I concur to a great extent with many of the last speaker's comments. Having this legislation before the House that has been in the making for the past nine years and on which there was extensive consultation in the past two years beggars belief. The people who entered the negotiations with the Tánaiste's officials did so in good faith. They are not unreasonable people. If we were dealing with unreasonable people, this debate would not be so calm. They are not rebels or out to cause trouble. Rather, they had normal lives until this happened to them. They needed to become politicised to provoke action and to ensure that their difficulties were managed in a statutory framework. While they achieved this, it was not easily done.

The next obstacle they needed to surmount was that of insurance. We are discussing young men and women who could not get mortgage protection and, therefore, could not get mortgages. We are discussing people in their early 50s who had paid their mortgages and wished to take holidays. Despite being nervous about getting sick while abroad, they could not get travel insurance because of particular health problems. We are discussing men and women with young families who could not get the life assurance policies that would have given them and their families a degree of comfort. These are privileges we all expect. For fear that anyone will claim that I did not say so, I should have commenced by stating that I have an interest in this matter, as I am rhesus negative and was given anti-D in 1977.

We are discussing normal people who were hoping to live normal lives. The events that occurred were not of their making. The people responsible walked away scot free, which was the greatest injustice of all. We are not only discussing women, but a range of people, such as young men and women and those in their prime as we would currently define it. These people had perfectly normal lives and in certain circumstances were given transfusions of infected blood. Women who went to hospital for what should have been one of life's most joyous occasions, namely, having a baby, received anti-D and suffered the consequences.

Why are these three provisions in the legislation? The Title of the Bill makes no reference to insurance, yet the Bill is fundamentally about that issue. It should be stand-alone legislation, but this is akin to a three-card trick merchant playing "Find the lady". In any major European city, a huckster putting together a three-card trick table would be arrested and run off the streets for fraud, but here it is in Parliament, introduced by someone whom we all expected to be a caring Tánaiste. She has been badly advised. When she stood up in the Chamber this morning and said that no one will be excluded by the Bill, she was not telling the truth.

There are people who have still not made the connection between infection and their ongoing bad health, nor has it occurred to their general practitioners. There are people who are about to fall in love with someone who has been infected. They are not considering compensation or their future beyond what we all considered when we fell in love, that is, a happy-ever-after ending. However, in this instance, it will not be happy ever after. There will be consequences and matters to be managed. It was in this context that the original compensation Act was introduced. It put in place a structure that enabled people to manage lives that had been altered by the State, not to research a cure.

When the Tánaiste says no one will be excluded, she is wrong. I do not know who is advising her, but those people are wrong. The reason they are advising her is interesting — the mindset of closing off an appalling vista. I have news for them. The appalling vista happened between the late 1970s and early 1990s. This Bill tries to set right the appalling vista and the Government, which appears to have a death wish, will bring down on its head an awful price that it must pay. Is it true that circumstances change but we do not, as mentioned by the last speaker? In this instance, it seems to be the case.

The Tánaiste rightly stated that Positive Action agreed that the definition should be based on a diagnosis by the ELISA test. That was the case in the original Bill presented to the then Minister for Health in 1995 before the 1997 Finlay report, which has been accepted as the Bible in the matter. The Bill is about the three-card trick and spin, but the latter will not work, as the people involved are so conversant with this legislation and so aware of the consequences of this change to their lives that they will not be fooled.

It is important that the conclusions of Ms Justice Finlay Geoghegan on this issue be read into the record. However, we now have evidence in the form of a letter from the blood bank, as it was then, to Ms Justice Finlay Geoghegan. Referring to the fact that only a maximum of 100 people were affected, which makes it astonishing that the Minister's advisers are allowing this to happen, it states:

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.

We need to start reminding ourselves that the first we heard of this was on "Morning Ireland" in 1991 or 1992. The first the blood bank heard about it was in 1990 or 1991, when the university in England which was carrying out the test for the blood bank wrote to the BTSB in Dublin. The letter was from the original report into what went wrong in the blood bank and stated that there was something in the blood. It was not non-A nor non-B but something else was there.

It was first discovered 15 years ago that hepatitis C existed. Now the Minister for Health and Children tells us that men, women and children who were infected in the peak year in 1977 should have a conscious history of their symptoms, but this disease does not have a history. We do not know enough about it, because it is so new. However, the Minister does, as do her advisers, who say if people test negative under ELISA it means there is nothing wrong with them. That is complete rubbish. Experts in the field will say they do not know everything about the disease, but they know that nothing is foolproof and that ELISA does not pick everything up. Women test negative for both antibodies and virus but will swear they have been infected and suffer the symptoms. How can the Minister say nobody will be excluded when people do not even make the connection between infection and symptom?

One witness called by the State, and I am sure the Department officials will know of this because they seem to know everything else, made a very telling report. He writes:

However, several longitudinal studies have documented the subsequent loss of antibody reactivity over time in those with cleared infection. In the East German anti-D cohort from whom early samples were available for testing, 18 from 43 women who cleared infection became seronegative for antibody over an interval of ranging 8-20 years.

An Leas-Cheann Comhairle

Does the Deputy have a reference?

Ms Lynch

The statement is by Professor Peter Simmonds. It continues:

Similarly, 11 from 63 cleared infection over 10 years from infection clearance, and a further 9 from 56 over 3 years in a community based study in Italy, comparable to the loss of antibody in prospectively followed haemophiliacs (3 from 12 over 6-15 years;) and post-transfusion non-A, non-B hepatitis patients (6 from 90 over at most 23 years;). In common with the seropositive individuals with cleared infections (see above), where investigated, none of individuals who became seronegative in these various cohorts showed evidence for ongoing replication of HCV, either from PCR testing of plasma samples, or from liver function test abnormalities attributable to HCV.

The lack of stored samples from women who received HCV-contaminated anti-D immunoglobulins in Ireland has prevented longitudinal studies of the outcomes of HCV infection comparable to the above studies. However, I am aware of the evidence presented at the HCV Tribunal that several women who received contaminated batches of Irish anti-D immunoglobulins in 1977 or 1978 became jaundiced shortly after prophylaxis (therefore providing evidence for acute infection with HCV), but who are now negative for antibodies to HCV. This is fully consistent with the findings for frequent loss of anti-HCV antibodies in cases of resolved infections.

This statement is by somebody who studies the subject for a living and was the State's witness. He says one can clear the infection and the antibodies but the symptoms will persist, but the Minister says they will not. She will only accept the very specific scientific ELISA test. Does she think consultants who testify on behalf of somebody who tests negative are telling lies? Does she not trust her own tribunal to deal with these issues? It is incredible that the Minister for Health and Children should replace a scheme that was working perfectly well with another piece of legislation, thereby retrospectively altering legislation which was hard fought for and was directed at a group of people, both men and women, whom this State infected. Whether we like it or not that is what happened. It infected them because we were not proactive enough in testing blood products.

The shutters came down after 20 June. I have asked for sunset clauses in legislation before and have been told they were not necessary but in this case one is applied on the day the Bill was produced and no further claims will be accepted after that date. That is outrageous. We have still not received an explanatory memorandum so I still do not know why it has been done.

The people affected constitute very small groups. One is rhesus-negative, pregnant women whose husbands were rhesus-positive. There are also small groups of people who received blood transfusions and who had renal failure.

The Tánaiste said €660 million has already been spent. I can see the headlines. People will ask what we are doing. Just over 2,000 people were compensated — that is how small the figure was. The consequences were not minute but the number was very small. The rest of the money will go to pay for the tribunal and legal expenses.

This legislation is mean and mealy-mouthed. I cannot find words to describe it. It also limits people who will never go to a tribunal or to the High Court and as a result of this alteration to the hepatitis C compensation tribunal legislation, they will not receive a medical card either. The Bill says to people to test positive after all this time. All the scientific data states that over a period of time, the majority of people will clear the virus and the antibodies. How is one to realise that test? It cannot be done. That test is not fool-proof and, hopefully, with the advance of science, we will have a better test which picks up things at a much lower level.

Another witness called by the State spoke about the effectiveness of the ELISA test. Dr. David Foster said, in response to a question about whether the ELISA test would pick up people who had been infected, that "There is a real danger that to exclude a person who cannot show a positive ELISA Test will give rise to injustice". He also said:

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 there 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 clearly there is a cut-off level.

He goes on to state that one could have a lower level and be infected but that one would not test positive with ELISA.

I still do not understand why the Government has introduced this legislation. There is paranoia in some Departments that we face an appalling vista and, therefore, we must legislate to restrict it. That appalling vista occurred between 1977 and 1991. I hope we will try to sort out what happened then rather than damn these people once again. This is appalling legislation and I appeal once again to the Tánaiste to abandon it and to come back with the type of Bill these people thought they would get, that is, a comprehensive one dealing with insurance.

Notice taken that 20 Members were not present; House counted and 20 Members being present,

Minister of State at the Department of Health and Children (Mr. S. Power)

I am happy to have the opportunity to speak on this very important legislation. The Tánaiste has already explained in detail the provisions of this Bill and commended it to the House. As the Tánaiste said, officials have been in discussion with the four support groups on the details of the Bill and have taken their concerns on board. One of the issues raised by the support groups and which was also referred to by several Deputies was the matter of the ELISA test. As a result, the Tánaiste has decided to table an amendment on Committee Stage to extend the number of tests that can be used to determine eligibility to include RIBA and PCR tests. Like the ELISA test, the RIBA test is also used to diagnose the presence of antibodies to the hepatitis C virus while the PCR test identifies whether the virus itself is present in the individual's bloodstream.

In addition, to cater for the development of new and more sophisticated tests in the future, the Tánaiste intends to table an amendment that will allow her to make regulations adding new tests to the ones already specified. As Deputy Lynch mentioned, tests are developing rapidly and she expressed the wish that some new tests might appear in the near future. We are allowing for that should it arise. When the Tánaiste opened today's debate, she acknowledged the contribution of the four hepatitis C support groups — the Irish Haemophilia Society, the Irish Kidney Association, Positive Action and Transfusion Positive — in working with officials on the details of the insurance scheme and thanked them for their significant effort in bringing matters to a conclusion. I reiterate the Tánaiste's sentiments and acknowledge the fine work done by the support groups, not alone in regard to this Bill but in representing their membership so assiduously over the past decade.

The Irish Haemophilia Society and the Irish Kidney Association were already in existence when the tragedy of hepatitis C afflicted their members. This gave both societies a new and tremendously difficult challenge to face in supporting their members, who not alone had to cope with the trauma of their underlying condition but had the added burden of another serious illness with which to cope.

Following the identification of the links between anti-D and hepatitis C in February 1994, Positive Action was formed later that year to represent the women infected with hepatitis C through the administration of anti-D. As information on the anti-D disaster became known, it became clear that the virus had been transmitted onwards via blood donations, and, as a result, Transfusion Positive was established in 1995 to represent the men, women and children infected with hepatitis C through blood transfusions administered within the State.

As we know only too well, hepatitis C does not respect age or gender. Those affected have included men and women, from the very young to the elderly and all ages in between. I am aware that State-acquired hepatitis C is often wrongly associated in the public mind as affecting women only. However three of the four support groups represent men as well as women infected with hepatitis C through blood transfusion and blood products, and their needs are always given due regard. The executive members of all four support groups have always striven to act as advocates on behalf of all the different strands that go to make up their membership, and have always been vocal in representing their interests.

From an early date the support groups entered into negotiation with the Minister for Health and Children and officials of the Department. It soon became clear they had a strong and coherent voice that needed be heard. During 1994 and 1995, Positive Action and Transfusion Positive were recognised formally by the Department as the main representative bodies for persons infected through anti-D and through transfusion respectively. That position remains unchanged today.

As the tragic effects of the hepatitis C virus became known and more sufferers were identified, the organisations' numbers grew. From the effects caused by hepatitis C came the solidarity of people supporting each other through adversity and working in the best interests of their relatives, friends and fellow members. The position of all four organisations was recognised when the Consultative Council on Hepatitis C was established in 1996, and all four were given a statutory entitlement to places on the council. From its first meeting in 1997 to its most recent meeting earlier this month, the support groups' representatives on the consultative council have worked tirelessly on behalf of their members to ensure their concerns were addressed.

The support groups did not confine their advocacy role to negotiations at the national level but undertook to represent their members in their dealings with regional and local services. At hospital and regional level the organisations have interacted with service providers to ensure the needs of their members are recognised and that services are responsive to those needs.

Transfusion Positive played a major part in lobbying for improved facilities for children with hepatitis C at Our Lady's Hospital for Sick Children, Crumlin, and this was acknowledged at the opening ceremony last year for the new medical tower at the hospital. To its credit, the organisation was always anxious to ensure that the very best facilities were available to all children with the virus, not only the children it represents. The dissemination of information to parents of children with hepatitis C has also been another area to which Transfusion Positive has made an invaluable contribution.

From 1994 onwards, Positive Action developed a strong and responsive organisational structure to support and represent its members. The organisation also developed effective lobbying skills and was instrumental in the establishment of the Finlay tribunal in 1996. The outcome of the tribunal led to a massive overhaul of the Irish Blood Transfusion Service, which is now at the forefront of international developments in transfusion medicine. It is a testimony to how far Positive Action has come and the high esteem in which it is held that its founder member, Ms Jane O'Brien, was appointed by the Tánaiste as a member of the board of the Irish Blood Transfusion Service.

The Irish Kidney Association was already faced with the enormous challenges posed by renal disease when some of its members were affected by the doubly cruel blow of infection with hepatitis C. Despite the thankfully small number of renal patients affected by the virus, the association from the beginning recognised the importance of providing professional counselling for this cohort and has been at the forefront of patient support and advocacy for its membership. In addition, the critical contribution of organ donation in giving new life to both renal and liver patients was always a particular focus of the Irish Kidney Association. Its chief executive officer is tireless in his efforts to promote organ donation awareness nationwide, not alone for the benefit of hepatitis C patients, but for the benefit of all those who need a transplant now or may need one in the future. The continued success of the Irish liver transplant programme, operated through St. Vincent's Hospital in Dublin, is a testimony to the sterling work performed by the Irish Kidney Association in promoting organ donation.

The special contribution of the Irish Haemophilia Society to the support of its members with hepatitis C cannot be over-emphasised. Nor can any of us comprehend the depth of the tragedy suffered by its members, having first become aware that so many of them were infected with HIV to then find that some were co-infected with hepatitis C. Others, having escaped the scourge of HIV, found they had instead been infected with hepatitis C.

The disaster which befell the Irish Haemophilia Society and its members has been well documented in the media and through the Lindsay Tribunal, but this is only part of its story. Most people will not be aware that despite, or perhaps because of the suffering they have endured, the Irish Haemophilia Society has played a major role in working to improve the lot of persons with haemophilia not alone in this country but around the world. The society is currently twinned with its counterpart in Bosnia and encourages other Western countries to participate in twinning arrangements with their less fortunate colleagues. The former chairman of the society, who for many years was also chairman of the World Haemophilia Federation, acts as a roving ambassador to haemophilia societies in some of the poorest countries in the world. He works tirelessly to assist them in gaining the most basic services for their members.

One of the hallmarks of all the support groups is the important role played by family members, sometimes as active members of the organisation or else providing invaluable support behind the scenes. Today, as well as acknowledging the role of the support groups, it is also timely to pay tribute to the families affected by the virus and to recognise the debt we all owe to these families. I hope the insurance scheme introduced in the Bill will go some way towards giving autonomy back to these families and allow them to avail of the mortgage and life assurance that are part and parcel of the essential supports every family needs to protect the financial security of its members on the same basis as the rest of the community.

First and foremost, however, the provision of this insurance scheme is a public acknowledgment of the needs and entitlements of the men, women and children infected with hepatitis C through blood and blood products. The credit for this must go to the chairpersons and executives of the four organisations, who have worked so hard and achieved so much.

There is no doubt this is an important measure that will provide support to people diagnosed with hepatitis C or HIV as a result of receiving contaminated blood or blood products from the State. For years it has been obvious that infected people's inability to buy life assurance and mortgage protection policies created additional difficulties to those they were already experiencing. The Bill addresses an inequity that has existed for several years. There has been criticism of certain aspects of the Bill but there can be little doubt that the scheme will be of great benefit to the persons infected with hepatitis C and HIV administered in State blood and blood products. I hope the amendments proposed by the Tánaiste will address some of the concerns expressed inside and outside the House in recent times.

Debate adjourned.

Dáil Éireann díospóireacht - Thursday, 29 Jun 2006