Selected Transcripts of the Archer Independent Inquiry

 
Thursday 30th August 2007


MR BRIAN O'MAHONY (called)

LORD ARCHER OF SANDWELL: Good afternoon, Mr O'Mahony.

MR O'MAHONY: Good afternoon.

LORD ARCHER OF SANDWELL: Thank you very much for coming. I think the easiest way would be if you wouldn't mind making your presentation and we can intervene as and when it arises.

MR O'MAHONY: My name is Brian O'Mahony. I have haemophilia B, sero-haemophilia B. I am currently the chief executive of the Irish Haemophilia Society and I was a board member of the Society from 1982 until 2003, so I was there right throughout the development of the whole AIDS situation and I was chairman of the Society from 1987 to 2003. I was also president of World Federation of Haemophilia for 10 years from 1994 to 2004.

In terms of percentages, you know, you are looking at a population of people with haemophilia about one tenth the size of the UK, but a similar percentage is affected with HIV and hepatitis C. We have approximate 400 with haemophilia in Ireland, and 104 were infected with HIV and 65 of those have died, about two thirds, which I believe is a similar proportion to here. 221 were infected with hepatitis C and 26 of those have died.

Obviously the vast majority of those with HIV were also co infected with hepatitis C and we are aware of only one individual who was infected with HIV who was not infected with hepatitis C.

MR MEHAN: Can you speak up a little?

LORD ARCHER OF SANDWELL: Do you know whether that has been the experience in most other countries?

MR O'MAHONY: Yes, I believe so. It is very rare to find someone infected were HIV but not hepatitis C, unless they had perhaps someone with mild haemophilia, who received one treatment or two treatments. You were talking about May 1983. I came on board the board of the Irish Haemophilia Society in October, November 1982 as a new board member, and I raised concerns in early 1983 with the board and I raised concerns at the time with our own blood transfusion service and clinicians in relation to our concerns about both AIDS and hepatitis and indeed at that time we were in contact with the UK Haemophilia Society and noted they had similar concerns in relation to AIDS and hepatitis at the time.

Back in 1983, right up to, I suppose, 1986, 1987, the Irish Haemophilia Society was a very small organisation. I would equate their resources almost something similar to a residents' association. When I was joined up, I was informed that I was being made honorary secretary and therefore all the mail would go to my house because there was no office, no staff, no resources. The annual budget was about £6,000. The Society raised concerns, as I say, in early 1983 in relation to AIDS. As things progressed and it became clear that many of our members were HTLP antibody positive, we started distributing condoms to our members, which of course was in contravention of the law in Ireland at the time, because as you know people in Ireland don't actually have sex, and therefore condoms were not available legally without going to get a doctor's prescription and the fact that we did distribute the condoms outside of the healthcare system and the fact that the healthcare system could not provide the distribution actually meant that we had no seroconversions of any of the partners with HIV, which I am very glad about.

In 1987 we conducted a full survey of all of our members with HIV to find out what their requirements were and they were very similar in fact to the requirements that the UK Society were finding at the time; lack of life insurance, no mortgage protection, inability to have a high protein diet, inability to meet the cost of hospital visits, so on and so forth. We asked our Government at the time to intervene and make provision for these areas, but in the absence of being able to do that we asked them to set up with a trust fund and in 1989, following, I would say, a long campaign with the Government they did eventually agree, following a General Election, to set up a trust fund called the Haemophilia HIV Trust.

LORD ARCHER OF SANDWELL: As we have been hearing about this -- you may have been in the room -- from your point of view it was second best, was it?

MR O'MAHONY: At the time, yes, we would have been much happier if they had provided the dietary supplements, the mobility supplements, the hospital care at the time. This was really fire brigade money because people were dying at quite a rate. They weren't able to have a high protein diet, they weren't able to cover the costs of their visits to hospital, so the trust fund was established to actually allow for that, without having to go through an enormous bureaucracy, in the sense that if somebody was ill at home, and they needed a special mattress, they would get permission for this two months after they died. So this allowed for this to be done very, very quickly. In fact it was very similar, the HHIV Trust was very similar in scope to the Macfarlane Trust that was set up in the UK.

In 1991, again I think very much in parallel with what was happening in UK people with haemophilia, with HIV in Ireland, had been taking legal action and that legal action was settled following again a campaign. The Government agreed to pay compensation to people with haemophilia who were infected with HIV. The sums paid were broadly similar to the sums paid here at the time in the UK to individuals.

LORD ARCHER OF SANDWELL: This may transfer to be important in a rather different context. Was the money which was paid a settlement of a legal claim?

MR O'MAHONY: No, what it was, in fact -- at the time back in 1988/89 quite a large number of people with haemophilia issued proceedings against both pharmaceutical companies and the Irish government and this in fact, the payment by the Government was conditional on them dropping the suit against the Government.

LORD ARCHER OF SANDWELL: I suppose it could be argued it was in effect a block settlement of a number of claims.

MR O'MAHONY: The payments were made very clearly on an ex gracia [ex gratia] basis without any admission of liability, but having said that, if someone wished to continue to take legal action against the Department of Health they wouldn't have received the payments, so those payments in 1991 were made on an ex gracia [ex gratia] basis, but they did settle legal claims against the Government at the time.

LORD ARCHER OF SANDWELL: I see.

MR O'MAHONY: But they should not be confused with later HIV compensation which was granted in 2002 and I will come back to that.

MR MEHAN: Brian, you have figures here. Can you quote them?

MR O'MAHONY: The compensation paid at the time in Irish pounds, a married man with haemophilia, the children received £101,000; £94,000 to a person with haemophilia who was married with no dependent children, £77,000 to a single adult or child, and £20,000 to the parents of a deceased person. So those were the payments made in 1991. From 1992 onwards hepatitis C was becoming an increasing concern to the Society and to our members. The clinical manifestation of hepatitis C was becoming apparent in more and more of the members and in 1994 we began discussions with Department of Health officials in relation to provision of treatment with Interferon, which was the standard treatment at the time. But at the same time in 1994 we also began discussions with the Department on hepatitis C compensation, and those discussions on compensation, the discussions on treatment were resolved satisfactorily very, very quickly. The discussions on compensation between ourselves and Department officials continued during the course of 1995 and by late 1995 we had reached agreement on the setting up of a non-statutory compensation tribunal where each person with hepatitis C would have their case heard and assessed on an individual basis. We had discussed that option. We had also discussed across the board ex gracia [ex gratia] payments, but the option that was agreed was a compensation tribunal and that was set up in 1995.

LORD ARCHER OF SANDWELL: Can I ask you this, because again this has a risk: the word "compensation" is used all the way through this, including the title of the Tribunal.

MR O'MAHONY: Yes.

LORD ARCHER OF SANDWELL: Compensation is sometimes thought to represent a payment by someone who is responsible for the condition; presumably that was not the position here, it was a response to a need, rather than compensation for a wrongdoing?

MR O'MAHONY: I think it was -- you know, there has always been a long debate in the haemophilia community about whether to use the word "compensation" or "recompense". To the majority of people what matters is if you actually get sufficient financial resources to allow you to live but in fact I would say the word "compensation" was used deliberately because even though it was paid without any expression of liability, I think it was very clear that they felt a moral responsibility, that they felt that this was a disaster which had befallen the community and they were making provision for that and the compensation was also paid to persons who were infected with hepatitis C through blood transfusion and through the provision of anti-D, and also to patients who had been infected following kidney dialysis treatment. So there were four distinct groups of patients.

LORD ARCHER OF SANDWELL: But there was a discussion as to whether that word should be used, was there?

MR O'MAHONY: Not really. I can vividly recall my first discussion with the department officials on this, where they refer to it as "the C word", but the word "compensation" was used right throughout this, but it was not -- it was a non-statutory tribunal at the time and there was no admission of liability, as such. In effect, it was almost as if you had an assessment of damages, because they assessed each case individually in relation to pain and suffering, in relation to state of health and relating to loss of earnings and so on and so forth.

So that was on a non-statutory basis. The first case was held in March 1996 and the first awards were made at that time and again. I want to emphasise the points that Roddy made earlier, that the first compensation payments were paid in March 1996 and this was well prior to both the Finlay Tribunal and the Lindsay Tribunal inquiry. By July of this year payments had been made to some 2,200 claimants.

DR NORMAN JONES: Can I interrupt a moment on that figure? It is probably just stupidity on my part, but I am having some difficulty reconciling that figure with the total haemophilia population of 400.

MR O'MAHONY: As I say, there were four cohorts of people: persons with haemophilia, persons infected through blood transfusion, persons infected through anti-D and persons who had been infected through dialysis.

LORD ARCHER OF SANDWELL: So if someone claimed for two separate headings, you're treating it for this purpose as two claims?

MR O'MAHONY: Nobody really claimed under the two separate headings, but in fact -- you had 220 people with haemophilia. You had about 1,000 people who received anti-D, you had a couple of hundred people who were infected through blood transfusion, but that figure would also represent spouses, would represent carers, would represent dependants, so there have been payments made to others, as well.

MR MEHAN: You mentioned another tribunal other than the Lindsay Tribunal. What was that again?

MR O'MAHONY: That was the Finlay Tribunal. I will come back to that. By July 2007 payments had been made to some 2,200 claimants, and again I would emphasise that the payments at this point have been extended, not just for the purposes of hepatitis C and HIV but to their spouses and carers and others. The total paid to date is 778 million euros. That is -- these are the figures from the Department of Health. If you were to average that amount over 2,200 you would come up with an average payment of €353,636 euros, but the payments ranged enormously, and they have ranged from €14,000 euros to €3.1 million euros in individual cases. Those figures were Department of Health documentation. The Compensation Tribunal publishes an annual report which gives very precise figures but the 2005 annual report is the latest available, and the 2005 report, the average award for that year was €143,647 euros. The range of awards in 2005, ranged from €14,000 to €1,624,383 euros, and the major difference, in fact, between those -- because it is an enormous variation -- would be a potential loss of earnings, so a young person with a very large potential loss of earnings would have the potential award.

MS JUDITH WILLETTS: These are ongoing. I assume there is a sort of natural end to the claim process?

MR O'MAHONY: Well, I will come back to that because in fact the claim process is not just the same process that started in 1996 -- they have extended that. If I can just go through that, I think it would become clear.

MS JUDITH WILLETTS: Sorry, yes.

MR O'MAHONY: Following the initiation of the compensation scheme, a tribunal of inquiry, the Finlay Tribunal was established and the hearings were held between October and December of 1996 and the Tribunal reported in March 1997. Now, we actually withdrew from the Finlay inquiry in December 1996 because it was clear that whereas the terms of reference initially looked as if they would deal with our issues it was very clear, in fact, that the terms of reference were being interpreted in such a way as to exclude the persons with haemophilia, with hepatitis C, and it was primarily devoted to looking at infections through anti D and to a lesser extent, through blood transfusion. We then entered into separate negotiate equations with the Department of Health in relation to setting up a separate inquiry into all aspects of the infection of persons with haemophilia, with both HIV and hepatitis C, and the Department clearly recognised that the Finlay inquiry's terms of reference, as they were being interpreted, did not deal with that, and this latter tribunal, the Lindsay Tribunal, the discussions on the terms of reference took a long time, took from 1997 to 1999 to get the get the exact terms of reference in relation to what was going to be covered and this tribunal of inquiry, the Lindsay tribunal, was established by the Parliament on 8th September 1999 and sat for 196 days from 27th September and 28th November 2001 and the report was issued in December 2002. Prior to the publication of the Lindsay report but following the personal testimony at the inquiry – and this is important, because quite a few people, similar to here, a lot of people with haemophilia gave personal testimony at the Lindsay inquiry and prior to any report being issued, the Government had re-entered discussions with the Irish Haemophilia Society. They had recognised that the HIV compensation paid in 1991 had been neither fair nor equitable, so they therefore passed an amended hepatitis C compensation bill in 2002 to allow for further compensation for persons with HIV. Crucially it also allowed, for the first time, for adequate compensation for the widows of those who had died, prior to the first settlement being made, because we always felt that in 1991 when compensation was paid, if a man with haemophilia received £101,000, if he died a week before that, his by widow or his parents received £20,000 -- the widow would receive the money, but there was an unfairness inherent in the system and I think that was recognised by the Government in 2002, so they broadened the scope of the compensation tribunal to include HIV as well as hepatitis C. I have to point out, which I haven't done, that the compensation tribunal was established in 1996 on a non statutory basis but it was placed on a statutory footing in 1997, that it was broadened further in 2002 to include HIV, but also to include other areas. It allowed for compensation for spouses, for partners, for carers, it allowed for compensation for loss of consortium, for loss the Society, for post-traumatic stress disorder, so there was a much broader range of compensation available, and that really is why they are ongoing, because you are really looking at from 1997 (inaudible) 2002 and each case is individually assessed, and that means medical reports, psychological reports, occupational therapy reports -- so there is quite of lot of documentation in relation to this. It is a slow process but very, very thorough.

MS JUDITH WILLETTS: It is a small point, but those original compensation payments, were they deemed by you to be about right, or did they appear to be somewhat arbitrary or somewhat strangely arrived at? I find it strange that, if you have children, you only get €7,000 euros more than if you haven't.

MR O'MAHONY: It was somewhat arbitrary and in fact I think one of measures as to how those figures were selected -- we looked at the UK compensation paid in 1991, where there was a difference made in different categories and selected somewhat from that. They were arbitrary, they were not adequate payments certainly, but given the situation at the time, the number of people dying from HIV was increasing dramatically and rapidly and they were facing this long interminable legal process where by the time it had finished nobody would be left alive. In 1991, it really looked as if everybody with HIV would be dead within three or four years, so the sort of compelling sort of thing to settle was there very, very quickly.

LORD ARCHER OF SANDWELL: It was quicker to short-circuit long arguments about whether some particular person would have earned £20,000 a year or 30,000 a year.

MR O'MAHONY: Absolutely.

MS JUDITH WILLETTS: They needed to take what they could, on the basis they didn't expect to live very long.

MR O'MAHONY: And in fact the figures were put to a meeting of all the people with haemophilia in terms of were they satisfied with the apportionment of that amount, and were they happy. The Government in fact just gave a block grant that was apportioned in that way, and the people with haemophilia themselves agreed with that so from that point of view it was satisfactory, but the amounts, in terms providing for families long-term, certainly were not.

MR MEHAN: Just to emphasise the point again, were they asked to sign waivers?

MR O'MAHONY: They were asked to sign waivers exempting the government and state agencies from litigation. The government were quite happy for them to pursue litigation against the pharmaceutical companies but not against they named Irish defendants. They were not asked to sign waivers about hepatitis, mind you, which was the situation here in the UK, where they received HIV compensation they had to sign waivers for HIV and hepatitis, which even at the time I thought was bizarre. The Lindsay Tribunal reported in September 2002, and I certainly don't propose to go through the report but just some of the major findings: again, 104 persons with haemophilia were infected with HIV. They identified two batches of Irish-produced Factor IX concentrate which were responsible for the infection of seven persons with haemophilia being with HIV, although the majority of the Factor VIII infections would have been due to imported concentrates. The Blood Transfusion Service was found to be responsible for the infection of one person who required precipitate. One individual was identified as infected through a contaminated pharmaceutical product from the Armour Company which was a product actually that was withdrawn and then reissued and subsequently infected one person. They found on the balance of probabilities that two thirds of persons were infected with HIV by the middle of 1983 and one third subsequent to that date. They found that a minimum of 217 persons were infected with hepatitis C. All products used for treatment of persons with hepatitis prior to 1990 were potentially infectious for non-A non-B hepatitis although to varying extents. They also identified Irish Factor IX, which was responsible for the infection of seven individuals with hepatitis C. The Blood Transfusion Service were responsible for the delay in the introduction of heat treated Factor IX concentrates.

The Tribunal found that there was an ambivalence of the Blood Transfusion Service with regard to infections which had been caused by non-heat-treated products in 1985 and 1986, a reluctance to acknowledge that their product had been the cause of infection. In fact right throughout the discussion with the Department of Health in the early 1990s that ambivalence remained and it was very difficult to get information on that. They also found that the numbers of consultant haematologists were inadequate and there were structural weakness in the medical administration of the Blood Transfusion Service.

LORD ARCHER OF SANDWELL: I will just clarify one matter, if I may.

MR O'MAHONY: Certainly, yes.

LORD ARCHER OF SANDWELL: "A reluctance to acknowledge that their product had been the cause of infection"; did that imply that they ought to have acknowledged it, or did the Tribunal simply say, "They didn't accept it and we can't go further than that".

MR O'MAHONY: The Tribunal were very gentle in their wording, they used phrases like "reluctance to acknowledge" and "ambivalence", but it was quite clear that the Blood Transfusion at the time constantly
stated, "All of these infections were caused by imported products, our products were perfectly safe", and that in fact was not the case.

LORD ARCHER OF SANDWELL: Yes, I see.

MR O'MAHONY: In fact, I have just looked at some of the dates from the UK and I think if you look at areas like introduction of HIV antibody testing, hepatitis C antibody testing and so on, one person did say to me that the reason that compensation was paid in Ireland and not in the UK was that the Irish Government were culpable and the UK Government were not.

LORD ARCHER OF SANDWELL: Yes.

MR O'MAHONY: Well, in fact HIV antibody testing was introduced in the UK in October 1985 and in Ireland in October 1985; hepatitis C antibody testing was introduced in September 1991 in the UK and in October 1991 in Ireland, so the same dates. In terms of self-sufficiency, which we placed a lot of faith in the early 1990s, in Ireland self-sufficiency was promised in 1980 and delivered to a limited extent in 1985. In the UK, it was promised in 1974 and delivered in 1987, so in fact there was a longer delay. There were a lot of parallels between the situation. ALT testing, for example, in Ireland was going to be introduced in 1987, as a surrogate marker for hepatitis C, and they then decided to delay the introduction pending its introduction in the UK; of course it was never introduced in the UK so it was then never introduced in Ireland. So I think there were a lot of parallels in terms of the timing of those, no major difference. The recommendations of the Lindsay Tribunal, if you look at the report, the recommendations cover two pages and we felt they were brief and somewhat general and really more principles than detailed recommendations. Among the recommendations were that the blood products supplied to persons with haemophilia should be of the highest standard and of highest safety that were available; that a co-ordinating committee in regard to the treatment and care of persons with haemophilia should be established with representatives from the various different organisations and groups in relation to haemophilia care; and this should include all aspects of the care and treatment of haemophilia, including the choice of blood products to be given, and the Tribunal was of the view that it was essential that this committee be properly resourced and have adequate personnel and office facilities available to it.

The Tribunal also stated that consideration should be given as to whether it would be desirable to have the committee established under statute, to ensure its efficient and effective operation.

They stated there should be greater co-operation and exchange of information among the various doctors treating haemophilia, and that a sufficient number of consultant haematologists should be appointed to posts throughout the country; that medical records should be kept and maintained in a more satisfactory manner; that complete and adequate national statistical records should be maintained at the National Haemophilia Treatment Centre; that doctors should ensure that test results in relation to patients are given to the patients as soon as the results become available; and that the Irish Blood Transfusion Service should establish protocols to ensure that if in the future new tests became available for infective agents a positive result of any such test would be communicated to the relevant donor as soon as possible.

The Tribunal decided it was not its function to decide issues of criminal or civil liability, and therefore it did not forward a copy of its report to the Director of Public Prosecutions.

Judge Lindsay also noted that the minister had commissioned a separate report in relation to the feasibility of holding a further inquiry into the role of international pharmaceutical companies and therefore she would not make findings in relation to that area, and she also noted in her report that the minister and the Irish Haemophilia Society had reached agreement in regard to further payment of compensation for persons with HIV and therefore she did not need to make any recommendation with regard to compensation.

If I can go on to the impact of, I suppose, the Tribunal on the Irish haemophilia community, there was initially a high degree of disappointment with the report among persons who were infected with HIV and hepatitis C. It was felt it was very vague and non-specific; the language it was felt was somewhat woolly; the recommendations were very general.

We were able to utilise the general recommendations very effectively, because we had submitted to the inquiry very strong recommendations for the future, and you know, where the chairperson said that this committee should be set up we were able to work with the Department to set up the terms of reference for that very effectively.

LORD ARCHER OF SANDWELL: But there was a general expectation that the report would be in more dramatic language.

MR O'MAHONY: Yes, and that the recommendations and the findings would be clearer and that the recommendations would be more specific.

LORD ARCHER OF SANDWELL: Yes.

MR O'MAHONY: But I think the process and the period leading up to the Tribunal were very important to the community for a number of reasons. First of all, many people with haemophilia were able to attend the inquiry and hear at first hand evidence in relation to, you know, the disaster that had befallen them, and going right back to the mid-1980s, when people were dying, when they were dying in secret, when they were afraid because of guilt, anxiety, fear of stigma, fear of discrimination, they were afraid to disclose to their friends, to their family, to their neighbours they had HIV -- this was a hidden disaster, it was hidden.

I can remember talking to a man who was trying to decide what to tell his two children before he was dying and he eventually settled on telling him that he had cancer, because if they knew the truth his children would have been ostracised, they wouldn't have played with other children. So all this was hidden. This was very important, that this was public. They went along, they were able to go along and give evidence in a public forum, which was hugely important.

DR NORMAN JONES: Excuse me, can I take up that point? Looking back on it now, was it really effective at destigmatising the situation?

MR O'MAHONY: Yes, absolutely, because I would venture that if you did a survey in Ireland you would find that a minute proportion of the population have read the Lindsay report, as with any tribunal report in one sense. But the coverage in the media was very constant and it educated the public about haemophilia, about HIV and hepatitis C. It educated them as to what had happened and people felt much freer in terms of saying "This happened to me", and so on and so forth. We had many individuals who gave personal testimony. There was a facility for them to do this anonymously or, you know, giving their name and details, and interestingly enough, a couple of people, who had decided to give anonymous testimony, when they started to see the public coverage, changed their minds and said, "Look, I am going to tell people about this, I have nothing to be ashamed of", that was actually very effective. I think for the individuals who gave personal testimony, speaking to them afterwards, many of them felt it was cathartic, that it really did help them to try to bring some closure in relation to this.

It was an acknowledgment that their story was being listened to, was being heard. It was very, very important for them, and it did lead to a much greater public understanding of the situation that had befallen people with haemophilia, and that got rid of the stigma, it got rid of the discrimination in many cases, and there was a lot of sympathy.

Following the Parliamentary debate on the inquiry report, the minister for health and children in the Parliament publicly acknowledged what had happened and issued an apology on behalf of the Government for the persons with haemophilia who had been affected and that was very, very important for them and he was -- he took great care to ensure that as many of the persons with haemophilia possible were present in the public gallery when he made the apology. It was very important for them.

MR MEHAN: Do you know the terms of that apology?

MR O'MAHONY: It is in the record of the Parliament, we can certainly get that for you.

MR MEHAN: It would be hugely interesting, what they were apologising about and for.

DR NORMAN JONES: Following that line, there is a viewpoint -- I am not necessarily saying I share it, but there is a viewpoint that such public apologies by governments for things that happened long past are absolutely ridiculous. There is no way that the people who make the apology had any influence on what happened in the past, even though they may be the successors in post. You are really saying that that is not true?

MR O'MAHONY: I am. I think you have to look at the amount of time that has elapsed. I think Tony Blair, when he addressed the Irish Parliament, apologised for the actions of Elizabeth I; that is four hundred and some years ago. The Danish ambassador recently apologised to the Irish people for the Vikings; that is going a bit far back. This is 20, 30 years ago.

LORD ARCHER OF SANDWELL: This has given some rise to some debate about it.

MR O'MAHONY: I think it is very, very important. The ministers who are there now, they were junior Members of Parliament, they were there, getting involved politically. This is not something that happened in the Victorian era, this happened in the last 20, 30 years, and I think an apology -- you are talking about things that happened in all of our lifetimes and their lifetimes and I think an apology is very much warranted in that situation.
LORD ARCHER OF SANDWELL: Of course there is a problem about issuing an apology for something when you are denying liable for it.

MR O'MAHONY: Absolutely, and the lawyers would readily say to them, "You should be very careful about apologising, because that has its liability". You know, in Parliament, Members have absolute privilege, and I think it is correct to use that to lay the truth out there and if the Government has made a mistake and they are responsible for something like this, they should say so.

DR NORMAN JONES: And it can be reassuring that someone is capable of saying sorry.

MR O'MAHONY: Yes. I wouldn't underestimate its importance. I think it was very important for the community. In the same Parliamentary debate the minister did say that -- and I can't remember the exact words, but words to the effect that no matter what happened with the Irish Health Service in the future there would be no question of cutting back on the quality of care available to people with haemophilia because of what happened in the past, so that was important as well.

DR NORMAN JONES: Thank you.

MR O'MAHONY: We had submitted our recommendations for the future to the Lindsay Tribunal and that included recommendations for a formal involvement of the Haemophilia Society in the future selection of blood products and in the formal involvement of the Society in relation to policy decisions on haemophilia, and recommendation number 2 of the Tribunal was the setting up of a co-ordinating committee in regard to treatment and care of persons with haemophilia, and I think in 2001, following representations from ourselves, a haemophilia products selection and monitoring advisory board was established on a non-statutory informal basis, initially, and following the report of the Lindsay Tribunal this haemophilia product selection and monitoring advisory board, which was basically a tender commission, was set up on a formal basis and that has been operating since 2001. I will come back to that later in more detail, if I may.

A National Haemophilia Council was established on statutory basis in 2004, to advise the minister for health and children and to make recommendations to the minister and all appropriate bodies in relation to all aspects of haemophilia care.

In relation to recommendation number 4, on more consultant haematologists; number 5, medical records; and number 6, accurate statistical records, a lot of progress has been made.

The National Centre for Hereditary Coagulation Disorders has been more adequately resourced as a result of the report and the regional centres and the national centre have appointed several new consultant haematologists since the Lindsay Tribunal, in addition to more nurses, psychologists, social workers and other specialist healthcare staff. The Department of Health and Children maintains a separate budget to allow for implementation of recommendations of the Lindsay report. So, for example, if a particular post has been asked for, requested, they say "We actually can budget for this under recommendation number 4 of the report".

MR MEHAN: Can I ask, do haemophilia patients now receive counselling?

MR O'MAHONY: Yes.

MR MEHAN: Did they before?

MR O'MAHONY: In 1980s and 1990s, very very little counselling and the vast majority of the counseling they received would have been from staff employed by the Irish Haemophilia Society. But there were more adequate counselling services available.

In addition, an electronic patient record system has been implemented by the National Centre and an IT system is currently being implemented to link the National Centre with eight other centres around the country where treatment is provided, so that any person with haemophilia, going into any one of nine hospitals, would be able to have an electronic swipe card which would record all of their relevant clinical details on that so they would be able to get treatment in those areas, where their details are known. The recommendations have been used with clinicians in accessing more resources for treatment and care of all persons with haemophilia.

I think that the setting up of the Tribunal in itself was a manifestation of the recognition by the Irish Government of the uniquely tragic nature of the infection of so many persons from one small group in the community with HIV and hepatitis C, and I don't believe that all of this flowed as a result of the Tribunal, I think the Tribunal was one manifestation of their recognition of this disaster, and there was a number of actions taken by the Government which made it clear they recognised the nature of the disaster.

In 1997, at the time when we were just discussing the terms of reference for the inquiry, the Government agreed the provision of recombinant products for all persons with haemophilia on an ongoing basis, and I think it was an acknowledgment of the reality that any subsequent inquiry or tribunal would inevitably find that persons with haemophilia had been exposed to too many unsafe blood products in the past and in the future they should always have access to the best available products at any given time. So they implemented the recommendation even before the recommendation was made, if you like.

Hepatitis C compensation was granted from March 1996 to a non-statutory tribunal and this was then placed on a statutory basis in 1997.

A hepatitis C consultative council was set up to advise the minister on all aspects of policy in relation to hepatitis C in 1996, and the Society is represented on this council which does extremely good work, including now the organisation of the international conference on hepatitis C, totally funded by the Irish Department of Health every second year.

The enactment on a statutory base in 1996 of a Health Amendment Act gave additional entitlements to additional health services to people with haemophilia who had been infected with HIV and hepatitis C through blood and blood products supplied by the state, and I will come back to that.

The setting up of the haemophilia product selection and monitoring advisory board allowed people with haemophilia a full formal role in the selection of products in the future.

The setting up of the statutory National Haemophilia Council allowed the Society a formal role in policy in relation to haemophilia.

Additional Government funding for the Irish Haemophilia Society was granted. In 2003, the annual grant from the Irish Government for the Society was doubled from 300,000 euros to 600,000 euros. This represents 90% of our funding on a ongoing basis.

The establishment on a statutory basis of an insurance scheme for persons who had been infected with HIV and hepatitis C. This bill was passed in 2006, and the regulations were passed in January of this year, and the scheme will be coming into operation actually next month, in September.

Let me just say a few words about these various areas. In relation to provision of recombinant products, recombinant products have an exemplary safety record. There has not been a single viral transmission of any sort from any of the recombinant factors since their introduction in 1994, and I think that the real fear among people with haemophilia -- I think the products available now, the plasma-derived concentrates available, are certainly safe from the hepatitis and the HIV. The real fear is the next virus. If SARS or West Nile could have been transmitted through blood products, it could have been another disaster.

But if there is another virus out there which is impermeable or not inactivated by the current viral inactivation techniques, then that could hit the community again, and people with haemophilia, if you are going to have a blood-born virus, they are always going to be hit because of the large pool of products that they use. So I think it was very much a source of great comfort to people with haemophilia that recombinant treatment products were made available 10 years ago and have been available since, and I think the provision of these products on an ongoing basis is in line with stated Government policy now, that cost will not be allowed to be the sole deciding factor in relation to the provision of haemophilia treatment in the future. Of course it is a factor, but it is not going to be the sole deciding factor. Safety, efficacy and quality will be paramount.

The product selection and monitoring advisory board meets six times per annum. This is the tender commission. It includes three clinicians, two representatives from the Irish Haemophilia Society, including myself, representatives from the Department of Health, the Health Service Executive, the Blood Transfusion Service, a virologist and a couple of other experts. We have two representatives on the board and we are also allowed to nominate our own external expert, who can accomplish us to any meeting that we wish.

I currently serve as vice chairman of the board, and the board has been very successful. We have carried out seven tenders since 2003 for the purpose of recombinant Factor VIII, recombinant Factor IX, and a plasma-derived concentrate for the treatment of von Williebrands and Factor X deficiency. So we still have to deal with plasma derived products for those other conditions.

LORD ARCHER OF SANDWELL: Does this principle goes so far as to say that cost doesn't enter into the choice at all?

MR O'MAHONY: No. It is a factor, Lord Archer, but I think you will find that -- and I have studied the tender process in many countries and produced a guidebook for WH. In many countries, cost is the only factor.

LORD ARCHER OF SANDWELL: Sure.

MR O'MAHONY: For example, in Bolivia, the officials who choose the blood products also choose the paperclips. Now, if you buy bad quality paperclips a cut finger is probably the worst thing that can happen. You can't have the same thing applying to Factor concentrates. So I think you have to have a balance.

In developed Western economies where we are not poor countries I think you can say that of course cost is a consideration, but you must look at safety, efficacy and quality, and provided you are looking at safety, efficacy and quality, and if you are looking at two products of similar safety, efficacy and quality, and one of them is significantly cheaper than the other, then certainly you chose the cheaper one.

We have actually published our selection criteria, it is very open and transparent, and we had, I think, for our last recombinant tender we had a 220-point scale for checking out each product, and cost came to just under 20% of the total score. So really, you know, if -- an unsafe product would not even be considered. What we tend to do is a two-stage process. We would look at the products -- let's say we get six products, six companies tender for six products. We will look at these and decide that four of these six meet our standards in relation to safety, efficacy and quality, and then we will look at cost. But cost is not the sole criteria.

MR MEHAN: Can I ask, are you looking at products on a regular basis? Are new products being developed all of the time?

MR O'MAHONY: Absolutely, and the commission does not just meet when we are doing the tender, because then we would be out of date. We actually meet six times a year and we keep up to date with developments and there are new products being developed and we get briefings and information on this.

MR MEHAN: Are you talking about product in relation to treatment of haemophilia or hepatitis C and HIV, or a combination of all three.

MR O'MAHONY: No, haemophilia, Factor VIII, Factor IX deficiency, von Williebrands, Factor II, VII, X, XIII; the rare bleeding disorders. Not HIV or hepatitis C treatments, it is not within the remit of the commission. It is replacement products for treatment of haemophilia and von Williebrands and rare bleeding disorders.

MS JUDITH WILLETTS: Recombinant treatment, because of the way it is manufactured, produced, must be safe from future unknown viruses, must it not?

MR O'MAHONY: You know, there is always a possibility of contamination. Look at the foot and mouth thing a few weeks ago from a laboratory. You can always contaminate any product.

MS JUDITH WILLETTS: Okay.

MR O'MAHONY: It is hard to see how you would get a human virus in a recombinant product, but there were concerns around zoonosis and animal viruses and using Chinese hamster cells and so on and so forth. So I think, you know, one thing that I think people think they have learned is that nothing is ever 100% safe, you will never take that as being read, and I think you also have to look at inhibitors as a potentially serious side effect of treatment, and there are some concerns in relation to the risk of inhibitors.

MS JUDITH WILLETTS: Yes, I understand that.

MR O'MAHONY: We will look very, very carefully at all of the criteria, and when you are doing a very full tender process like this and you are examining all of the products fully, and we have very, very specific criteria, we demand all of the information from the companies, and then we have a very, very good discussion and what has been really interesting is the way that every single person in the room will contribute to the discussion and then we will come to a consensus on the score for each product in each area, and it has been a remarkably successful process.

I think if you were to talk to the Department of Health officials they would be probably quite concerned about this initially, thinking this would maybe be a woolly process, maybe too elongated, and also would cost more. They were very pleasantly surprised; the first major tender came in about 4 million euros under budget, because we made the process more competitive. The process in the past would have been they would have discussions with one company at a time. We had them in one hour after the other, they were each given 45 minutes to present and it was made very, very clear, "You are now in competition, the cosy arrangements of the past are gone", and I think the prices actually came down, which was interesting.

I think it has been a very, very good process, to the extent I was asked by the World Federation to produce a guidebook on national tenders. I produced that in 2005, and it is now becoming an increasingly recognised trend in developed and developing countries that if you are going to have a tender process for the purchase of Factor concentrates then you must involve representatives of the National Patient Association if you are going to have a good process.

This is not only in Ireland, as I think I have already said: Canada, Australia, Japan, Brazil, Uruguay, Georgia, Thailand are among the countries now who have the Haemophilia Society involved in the tender process.

MR MEHAN: Can I ask you to slow down a little bit more?

MR O'MAHONY: The co-ordinating committee that Judge Lindsay referred to, she said that it should look at all aspects of treatment and care, including choice of blood product, and we clearly set up the choice of blood product in a separate body, which was the tender commission. The co-ordinating committee is the National Haemophilia Council. This was set up on a statutory basis in 2004 to advise the minister and to make recommendations in relation to the care and treatment of persons with haemophilia, protocols for treatment, health services for persons with haemophilia, education and training of staff to provide services for persons with haemophilia, education and health promotion for persons with haemophilia and their families, and the changing needs of haemophilia in order to ensure that the Health Services respond effectively to those needs, developments arising from research, and appropriate support service for the families of persons with haemophilia; very broad-ranging terms of reference.

The Council includes three commissions, a specialist haemophilia nurse and two representatives from the Irish Haemophilia Society, including myself. There are also representatives from the Health Service Executive and from the Department of Health and Children.

The Council has been very successful. It has been responsible for the production of national treatment protocols which were produced in conjunction with the clinicians and the haematologists throughout the
country. They have been responsible for the recommendation and priority allocation of resources for the different haemophilia treatment centres.

That is an interesting point, because this is something that the Department Health very quickly saw the advantage of. You have now got three haemophilia centres, each of them saying, "Please, we need a new haematologist, we need an extra haematologist", and they can now throw this back in the lap of National Haemophilia Council and say, "Okay, we now have three of the centres saying that they want a haematologist; you tell us which is first priority, which is second, which is third", and you now have the doctors, the Department and the patient organisation making that representation together.

And they have seen the advantage of this, because this gives them a certain amount of cover, if you like, for the decisions they are making. And we are happy with that, because this means there is full participation in the decision-making process.

The Council is involved in auditing at the centres. We carried out a very good look back programme for HIV and hepatitis C, where we ensured there was nobody in the country who would receive concentrates who had not been tested for HIV and hepatitis C.

We did a national information programme on the risk assessment for variant CJD following the risk assessment in the UK in 2004, because quite a few people in Ireland had received products in the UK over the years, and the Council also wants annual information days. Last year we had a very good information day, for example, on the future. We had three speakers all taking different views on what the future holds.

The Council provides an ideal form for ongoing co-operation between clinicians, the patient organisation and the Health Service in relation to optimising the utilisation of resources available for haemophilia and then prioritising areas for further improvement.

Interestingly, the Council can also act as an appropriate forum for discussion of potentially contentious issues in a non-adversarial environment.

DR NORMAN JONES: Can I stop you there? Have there been instances of that?

MR O'MAHONY: Absolutely, there have been arguments about, "This should not be the policy, that should be the policy", where there have been complaints about the service being provided by a particular hospital. Where these had not resolved in discussions between the clinicians and the hospital and the Society, they would
be taken to the National Haemophilia Council and all of the situation would be fully teased out and recommendations made. It has worked, it has worked very well.

There are always going to be tensions, there are always going to be differences in emphasis and you know, different expectations about what the service could and should provide and the Council gives you a forum where they can be discussed, debated and decided without people destroying the relationships that are there.

In fact, I think you were asking earlier, Lord Archer, about the differences between the doctors and the Haemophilia Society and so on -- this type of forum, I think, works extremely well, because we will of necessity still have differences of opinion with the doctors and certainly with the health officials. But we can also get together and decide on coherent policy initiatives in a body like this.

DR NORMAN JONES: Looking like the range of activities which the Council undertakes, including such things as look back studies, what sort of size staff and secretariat?

MR O'MAHONY: Interestingly, the Council doesn't actually do the work, it is carried out under the auspices of the Council. So they would direct the centre to do this or in some situations there might be an information campaign the Irish Haemophilia Society might be asked to undertake.

To give you an example, it was realised that many new doctors and nurses coming into haemophilia care have never really seen the worst sequelae of untreated joint bleeding, so we produced a DVD where we had people who grew up in the 1960s and 1970s talking about the difference between growing up then and growing up now, and this has now been distributed to the doctors and nurses.

DR NORMAN JONES: So it initiates and facilitates, really.

MR O'MAHONY: Yes. There are two staff, and it has its own office, it has a staff, a small staff -- but it also gets crucial support from the Society, from the centre and from the Department of Health. It was made very clear in the recommendations at Lindsay that if you look back in the early 1980s, there was a National Haemophilia Committee in Ireland, but it was toothless and powerless, and you had the doctors and the Department of Health and the Haemophilia Society sitting in a room where basically, at the time, you were told what decisions had already been made and implemented and ideas would be put forward and nothing would ever happen; no staff, no resources, no follow through, and it was not an a statutory basis. It was basically an opportunity for people to get together for coffee four times a year and waste of time, really.

DR NORMAN JONES: Would the Irish Department of Health regard a recommendation from the Council as binding?

MR O'MAHONY: Not necessarily binding, but they would be very loath to dismiss it.

DR NORMAN JONES: They would have to have a very, very good reason.

MR O'MAHONY: They would have to have a very, very good reason. I think what they certainly will do is they will come back and say, "We been asked for resources in three areas, we can do one this year and one next year, what is your recommendation?" They don't have to take the recommendations, but I haven't seen them refusing the recommendation.

LORD ARCHER OF SANDWELL: Do you think the difference is largely that it is now statutory?

MR O'MAHONY: The difference really is the acknowledgment of what happened in the past meant that the situation has to be changed, so it is statutory, you have an independent chairperson, and a formal involvement by the Society. Back in the 1980s, I attended a couple of meetings, and basically they were an opportunity where you could be told what had transpired in the previous three months. There were no decisions taken at those meetings. So I think being on a statutory basis adds tremendous weight to the committee. If it was non-statutory it is advisory, and advisory committees come and go. We had a particular minister for health back in the 1980s who if you wanted to not take any action you could always set up an advisory committee who would advise six months later when the issue had gone away.

LORD ARCHER OF SANDWELL: An old ploy, yes.

MR O'MAHONY: Yes. So I think the fact that this is there is important.

LORD ARCHER OF SANDWELL: I am not sure if I caught this, if you said it; are the meetings in public, or are they confidential?

MR O'MAHONY: The meetings are not in public, but the minutes are available to anybody who asks for them. The Council does not meet in public.

LORD ARCHER OF SANDWELL: I see, but the conclusions, the recommendations to the Government, are they made public?

MR O'MAHONY: Yes, they would be. Not in a constant manner. I guess -- certainly the minutes are available under freedom of information, the minutes are available to any of the clinicians who request to see them, the officials ... There is no nothing secret about the deliberations.

LORD ARCHER OF SANDWELL: If the Government said, "We don't accept your recommendation", it would be possible to make it public.

MR O'MAHONY: Absolutely.

LORD ARCHER OF SANDWELL: "This is what the argument is about".

MR O'MAHONY: If the Government did not accept the recommendation you would be reading about it in the newspapers, because it would certainly be made public. And in fact, Roddy was talking earlier about the need to have meetings with the secretary of state for health. We would meet them once a year just to present the annual report to the Council and we would meet on them on other occasions during the year when situations arise.

LORD ARCHER OF SANDWELL: And the annual report, of course, is made public.

MR O'MAHONY: Yes, yes, yes. The Hepatitis C Health Amendment Act, I referred to the 1996 legislation which gave each person with HIV or hepatitis C a special card which they could use to facilitate faster and more flexible access to the Health Service, and the card entitles the person with hepatitis C or HIV open access to hospital facilities, including the right to a public hospital bed, prioritised access to see specialists, and prioritised access to hospitalised admission. And the card holders also are entitled to the following services free of charge: general practitioner visits, prescribed drugs for any condition, counselling, complementary therapies, dental treatment and appliances, home nursing services, home help support services, ophthalmic services and physiotherapy.

It is a very, very broad range, and what it basically serves to identify is the fact that a person with haemophilia who has been infected by HIV and hepatitis C, any subsequent health condition they have or will develop will either be as a result of that or will be greatly impacted by their haemophilia or hepatitis C or HIV.

DR NORMAN JONES: We heard earlier today from Mr Morrison a comparable list, really, drawn up by the Haemophilia Society as a recommendation, and it had in addition to the various aspects you have there, "Treatment overseas if necessary, (liver transplantation)", in the context of hepatitis C.

MR O'MAHONY: Yes, yes.

DR NORMAN JONES: You haven't.

MR O'MAHONY: We do. That is because I neglected to put it on the list. It is in fact available. For example, any person with haemophilia and HIV in Ireland, who is co-infected with HIV and hepatitis C, if he requires a liver transplant, it is carried out in London. Because the numbers are so small, it really doesn't make sense to have them done in Ireland. In fact, there would be no problem -- we have had one person who enabled to have a liver transplant in the United States because their particular set of circumstances meant there was a better chance of success. So in fact there is a provision for treatment overseas.

DR NORMAN JONES: Thank you.

MR O'MAHONY: It is there. I think what that legislation has meant, really, is that the person with haemophilia who has HIV or hepatitis C has not had to bear any burden of financial cost for their illness or for any other medical condition, and that has been really, really important. It is very important for the person with haemophilia, with hepatitis C and HIV to visit their doctor constantly, to be assessed constantly in relation to the state of their liver and their immune system, and that is not facilitated if they have to pay for treatment or if their ability to access that treatment is made
difficult, and I think this legislation has been extremely important in terms of preserving their health as best they can.

The provision of insurance is being made at the moment and that Act was passed in 2006, and it allows for the provision of life insurance, mortgage insurance, remortgage insurance, for someone who has already purchased their house, and travel insurance, the idea being that the person with haemophilia, with HIV or hepatitis C, will be entitled to avail of life insurance, mortgage insurance and the other insurances at the same premium they would pay for a person their age who is perfectly healthy, and the Government would pay the additional loading.

It is envisaged that the people would be divided into two broad categories: you might have, for example, persons with hepatitis C, who are antibody positive, or perhaps PCR positive also, who would be loaded, so there would be an additional premium charge by the insurance company; the Government would pay the additional premium.

DR NORMAN JONES: In agreeing to pay this additional premium, do you know if the Government has been in consultation with various insurance companies?

MR O'MAHONY: In fact, yes. The implementation of the scheme is being put together by an insurance steering group and again I sat on that group and we have representatives on that group and we have been in consultation with a number of insurance companies. The scheme has been clearly set out to them and we have now got, I think, two companies who are going forward with the scheme at the moment. I think the idea is that they would pay the same premium that would be paid by a person their age who does not have any medical condition.

As I said, on one side you would have people who would be loaded and on the other side -- for example, we expect that many of the individuals who were co-infected with HIV and hepatitis C will be deemed by the companies to be uninsurable. In this case, the person will still be able to avail of mortgage insurance and life insurance and they will pay the normal premium that they would have paid if they were perfectly healthy, and the Government will basically assume the risk.

LORD ARCHER OF SANDWELL: Will assume the risk?

MS JUDITH WILLETTS: So the Government becomes the insurer.

MR O'MAHONY: In effect, yes. The person still pays their premium to Acme Insurance Company, and the Government makes an arrangement with them and in the event that the person dies, then the Government actually -- the payment comes through the insurance company but it is the Government --

MR MEHAN: They are underwriting it.

MR O'MAHONY: Yes. The insurance cover will be available up to the age 75 and travel insurance will also be provided under the scheme. In the past, and as I said, going right back to 1988, we had clarified that it was very, very difficult for people with haemophilia and HIV, and indeed hepatitis C, to get any access to life insurance.

LORD ARCHER OF SANDWELL: Can you satisfy some curiosity when I read that? Why a cut-off point at 75? Is it that in fact that there are not likely to be any sufferers still alive at 75, or is it that at 75 you are probably uninsurable anyway?

MR O'MAHONY: I think it is the case that at 75 it is more difficult to get life insurance on any sort of decent premium, so they insisted on some sort of cut-off date. We were arguing for 95, but they wouldn't bite that one. In fact, if you look at the situation, if it wasn't for HIV and hepatitis C, if a person with haemophilia could get to the point where men generally start to have heart attacks you have an advantage, because your risk of coronary thrombosis a much lower if you have haemophilia. So I think the 95 was reasonable, but they wouldn't bite. But it does cease at the age of 75.

What this does, it in effect allows the people with haemophilia to make provision for their independence, and it is hugely important. That scheme was difficult to put in place, it is quite novel, and it took seven years of discussion and negotiation to get that in place.

MS JUDITH WILLETTS: Yes, I am sure.

MR O'MAHONY: But I think if the UK Government would look at something similar, a lot of groundwork has been done; you have the same insurance companies. If I can go on to funding for the Haemophilia Society, the Irish Haemophilia Society has received a substantial proportion of our annual funding from the Irish Government for the last 10 to 12 years and as I stated earlier, in 2003 this funding was doubled from 300,000 to 600,000 euros per annum. That is now some 90% of our annual funding requirements. It is recognition that the Society provides a valuable role and provides unique and distinctive services for persons with haemophilia and related bleeding disorders. Without this funding it simply would not be possible for us to provide the advice, support, assistance, information, education, practical support and the programmes that we run for persons with haemophilia, including those with HIV and hepatitis C.

LORD ARCHER OF SANDWELL: From the Government's point of view, it is probably an economical way of providing those services.

DR NORMAN JONES: £400,000 a year.

MR O'MAHONY: Yes, they have looked at the fact that if they had to provide these services through the Health Service first of all it would cost more and secondly, many of them you just couldn't provide through the Health Service. I think they recognise it is cost-effective from that point of view. As I said earlier, the saving from the first tender alone was 10 years of that funding.

In terms of compensation abroad, I think in addition to Ireland compensation for hepatitis C has been paid in Canada, Hungary, Italy, New Zealand, Spain, Sweden, and in the UK to, in my view, an inadequate extent.

MR MEHAN: You don't mention France.

MR O'MAHONY: I don't mention France, you are correct. The list is not exhaustive. I think the French/Italy compensation is due to litigation, so I didn't mention that. Now, the French do make monthly payments to persons with hepatitis C. I haven't included there countries that make regularly monthly payments which include France and Italy. But this is a sample list, it is not a full list, there is constant change. France and Italy make monthly payments of about 400 euros per person to everybody with haemophilia or hepatitis C. I think compensation is a recognition of the fact that the treatment in most cases is provided by the governments, and also the unique problems faced by persons with haemophilia who are infected with HIV and hepatitis C -- and there are different problems faced by people with haemophilia who have these viruses than other members of the population.

First of all, people with haemophilia are already coping with one life-long condition and you are now adding to that mix one or two other life-altering conditions which all interact with each other, and the treatment for one could contra-indicate the other. For example, one of the main side effects of treatment for haemophilia C is anaemia. Well, that is exacerbated if you have an underlying bleeding disorder, so it becomes more difficult.

Many person with haemophilia, in addition to being infected with HIV and hepatitis C were also infected with hepatitis B in the past and also in some cases hepatitis A. They have the full spectrum, and you know, concurrent infection with A, B and C can actually cause more liver damage.
Hepatitis C infection in haemophilia tends to have resulted from many exposures to hepatitis C. For example, somebody who is infected through blood transfusion may have received one, two, three or four units of blood, but a person with haemophilia was getting pools of product which were infected. So they were exposed on many occasions to many different genotypes which generally results in higher viral loads, mixed genotypes and a preponderance, unfortunately, of genotype I, which is the most resistant treatment.

In comparison with the Irish cohort of women with anti D, who were perfectly healthy women who received anti D following pregnancy -- and you know, they have looked at the clinical outcome to date in that cohort -- people with haemophilia generally have a worse prognosis. A liver biopsy can be more problematical. A liver biopsy is not something you do without thinking in a person with haemophilia. The side effects of treatment can be exacerbated by the haemophilia and the progression of their hepatitis C can be more (inaudible) HIV co-infection.

It is ironic in one sense that HIV therapy, thankfully, since 1996 and the advent of heart therapy has markedly improved, so the mortality from HIV has decreased and they have survived since 1996. But it is ironic in that situation that their underlying immune disorder means they are more susceptible to a more rapid acceleration of liver damage due to hepatitis C. So there is a difficulty still there. We are actually seeing that in a person who is co-infected with HIV and hepatitis C in general, statistically, their liver disease will progress more rapidly.

So I think hepatitis C is a chronic life-threatening, life-altering condition, as indeed is HIV. And I think in some cases governments may seek to avoid legal responsibility, but they should be forced to acknowledge their moral responsibilities in these areas.

MR MEHAN: Do you have any statistics on remission from hepatitis C?

MR O'MAHONY: Remission? Spontaneous remission or treatment?

MR MEHAN: Treatment or spontaneous.

MR O'MAHONY: If you look at the statistics that are published in terms of hepatitis C they will often talk about 20% of people will spontaneously cure the virus. I think in our case we have seen very few cases of spontaneous remission. I would put it at less than 10%. In terms of the efficacy of the treatment, the early treatment with Interferon, in our experience, has about a 9% success rate. The treatment with Interferon Ribavirin had a better success rate, but still not great, and then when they switched to pegylated Interferon Ribavirin the treatment, the success rate is 40% to 80% -- it is 80% with genotype II and III.

The early treatment for hepatitis C in 1994 with Interferon, success rate of about 9%; later treatment with Interferon Ribavirin, a higher rate of success. But it wasn't until the advent of pegylated Interferon Ribavirin that the success rate went up, and the success rate for treatment of genotype II and III is now around 80% on six months' treatment. The success rate for genotype I is about 40% on 12 months' treatment.

Unfortunately, as I said a few moments ago, the vast majority of people with haemophilia have genotype I, which means it is the one that takes 12 months' treatment and it is the lowest success rate. They are the current rates.

If I can go on to just say some remarks about the former involvement of the Haemophilia Society in decision-making, it was actually a question, Dr Jones, you asked earlier: why haemophilia, why not every condition, would this not lead to a bureaucratic nightmare? It is a reasonable question, and I think one that has been to be answered.

I think unlike most medical conditions haemophilia is hereditary, it is life-long. Your mother may have been a carrier. If you have haemophilia your mother may be a carrier, your children can have haemophilia, your daughters can be carriers, your grandchildren can have haemophilia.

In my case, for example, as one example, I had four uncles with haemophilia, three brothers, one of whom survived, and four cousins. So there are almost enough of us to form our own society. So it is going right through the generations, so the level of knowledge about haemophilia grows remarkably in those situations. In fact you are taught, as a person with haemophilia, if you go into a hospital, do not ask the doctor how you should be treated, you tell him what treatment to give you, because you will know a lot more than the average junior hospital doctor, and that is the case.

I accept that if it was not for HIV and hepatitis C there would not be the same imperative. The history has changed not just the clinical history of haemophilia, but it has changed the outlook and the nature of haemophilia societies fundamentally. I think if it wasn't for HIV in 1982 and 1983 that haemophilia societies would have gone along gently with every-improving treatment if HIV and hepatitis C had not come along, and there would not be a compelling case for the formal involvement of the Haemophilia Society.

But I think the case now is utterly compelling because you actually get better decisions made with them in the room, because they actually have more knowledge, and I have seen this in our work at the World Federation of Haemophilia, that the most knowledgeable people I know about blood products, about haemophilia products, are in fact people with haemophilia, who have put a lot of time into this over the years.

I have set out the formal involvement of the Irish Society in relation to decision making on a statutory basis. However, I would like to point out in other countries there is also formal involvement, and in some situations that has occurred directly as a result of inquiries into HIV and hepatitis C.

The United States Senate had an Institute of Medicine inquiry in 1994 at which I gave evidence and, following that, the National Haemophilia Foundation, which is the United States patient organisation, are formally involved in the bleeding disorders advisory board and the Food and Drug Administration drug products advisory committee and in the FDA transmissible spongiform encephalopathy advisory committee – my apologies for that, just call it TSCAC, it is the variant CJD committee. In Canada –

LORD ARCHER OF SANDWELL: In the United States, is this problem generally addressed at federal level?

MR O'MAHONY: The Americans don't like "national" anything. I spoke at the FDA blood products advisory committee; when I mentioned national tenders I could see the hairs standing on the back of their necks. They generally would have some federal guidelines and federal oversight, but it would be dealt with on a state by state basis. So they would never have a national tender, for example. But they would have state tenders and sometimes conglomerates of hospitals getting together to tender for product. In Canada, following the Queever Commission of Inquiry, the Canadian Haemophilia Society are formally involved in the Canada expert advisory committee on blood regulation and the tender committee of Canadian blood services, and the Quebec tender committee as well, and on the Canadian Blood Service board of directors, and on the Canadian Blood Services national liaison committee.

In Australia, following the Senate inquiry into the infection of persons with haemophilia, the Haemophilia Foundation of Australia are now involved on the National Blood Authority board and on the National Blood Authority tender evaluation technical committee, and on the National Health and Research Council. In Japan, following HIV litigation, the Haemophilia Society is now involved in the Ministry for Health and Welfare advisory committee on blood products. In Thailand, when they did their first tender, their first national tender last year for Factor concentrates, the Haemophilia Society were involved, and I was asked by the Thai Government to attend as an expert adviser to the Society on that occasion. In Georgia, the Government have established a National --

LORD ARCHER OF SANDWELL: We are talking about Georgia in eastern Europe?

MR O'MAHONY: Yes. This is interesting, because this is a country where they have just started developing haemophilia care in the last three or four years, and they are learning from best practice. They are now seeing best practice means you include the clinicians and the patient organisation in the decision-making process, and in fact the first formal meeting with the deputy minister chairing the meeting is taking place next week, and I am attending the meeting. But it is interesting that they are looking at this now as best practice.

In Russia, the Federal Health Services have signed an agreement with the Haemophilia Society for the setting up of a National Haemophilia Care Programme.

In Brazil, the Haemophilia Society is involved in the national tender technical committee, and that is also the case in Ecuador, in Tunisia and in the Lebanon, so you can see an enormous range of countries, varying from developed to emerging countries, are formally involved in the patient organisation and the decision-making process (inaudible).

There is a recently established clinicians group in Europe, the European Association for Haemophilia and Allied Disorders, which brings together the leading haemophilia clinicians in Europe, where they are going to look at doing joint research on various projects and look at various guidelines for care, and they are drafting European treatment protocols, draft European treatment protocols.

This group includes prominent UK haemophilia treatment clinicians and in their principles of haemophilia care, and I am quoting directly from those principles, they state: "Clinicians and patient representatives must be part of national and/or regional haemophilia care decision making in partnership with ministers for health and social affairs and those organisations that deliver haemophilia care."

So it is now recognised by the leading clinicians in Europe that you must have the patient organization represented in the decision-making process.

LORD ARCHER OF SANDWELL: Is this based on the EC?

MR O'MAHONY: It is broader than the EC.

LORD ARCHER OF SANDWELL: It is non-governmental, presumably.

MR O'MAHONY: It is non-governmental, and the clinicians have got together themselves. Now, I think they have already drafted a statement of European haemophilia treatment principles, including the statement I have just made there, and I expect they may get some funding from the EEC to forward that work and to do more work in relation to that. But it would also include some of the countries in eastern Europe which are not currently EC members.

LORD ARCHER OF SANDWELL: I see, thank you.

MR O'MAHONY: If I can conclude by saying that approximately 4,670 person with haemophilia contracted HIV and/or hepatitis C as a result of treatment with contaminated blood or blood products in the UK, and the infection of people in the UK and in other countries, including my own country, is an appalling and unprecedented medical disaster to befall one limited community of people, and I am aware that the Society had been calling for some years for a formal inquiry, and I would like to congratulate you, Lord Archer, and your team, for setting up this independent inquiry, which I hope will assist the people with haemophilia in getting some answers, and I also I hope will assist them in getting some closure for at least some of these issues. In my view, a society should be judged not on how it treats the wealthy, the influential or the healthy. It should be judged on how it treats the poor, the ill or the disadvantaged, and many of the thousands of people with haemophilia who have been infected with the HIV and hepatitis C, through the administration of state-provided blood and blood products, have died.

Many others are living in poor health, without any guarantee of access to the best available healthcare on an ongoing basis. Without the assurance of the provision of optimum healthcare in the future and with the constant worry of not being able to provide for themselves and their families financially, I strongly endorse the submission from the UK Haemophilia Society and the United Kingdom also carries out one to three national tenders for the purposes of Factor concentrates on an annual basis.

I would also be of the view that a National Haemophilia Committee should be established in the UK to include representative clinicians from the Haemophilia Society and from the Ministry for Health to allow for formal input by the Haemophilia Society --

LORD ARCHER OF SANDWELL: At the risk of being tiresome, could I interrupt just once more?

MR O'MAHONY: Sure.

LORD ARCHER OF SANDWELL: I was wondering what the system for procurement is here. We have been told that normally Haemophilia Centre directors or hospitals procure -- make their own procurements and deal directly, contractually with the suppliers. But there is such a thing here -- I don't know how you pronounce -- RHD-CDO(?).

MR O'MAHONY: Yes.

LORD ARCHER OF SANDWELL: That makes provision for bulk contracts, does it?

MR O'MAHONY: I think that there was a tender commission here with the Health Procurement Agency, and you have some of the Haemophilia Centre Directors involved. My understanding is that I think in 2003 there was one national tender for England. I think at the current time there are three national tenders. I think Scotland makes its own arrangements, I think the London area makes its own arrangements, I think there is another tender for Wales --

LORD ARCHER OF SANDWELL: I see, so they may form groups for this purpose.

MR O'MAHONY: Yes, but there isn't --

MR MORRISON: It has moved on and changed slightly this year. I think it is a two-stage tender covering England. But the actual tender process would be viewed as non-compliant with best practice in terms of involvement. It has driven out fantastic cost reduction, but the process of doing that has had firms of consultants involved in doing that. I couldn't describe it adequately, but we can arrange to bring that to the table.

LORD ARCHER OF SANDWELL: Again, I would be grateful. It sounds as though it is not very formal. It is a fairly loose agreement to co-operate.

MR O'MAHONY: I think it is pretty -- my understanding is that it is pretty formal, but the involvement of the Haemophilia Society is not formalises, and I think that my understanding in the past here is that they have invited the Haemophilia Society to participate as observers or to be there, when they remember to do so. There is a difference between that and being in the room as of right, a vast difference.

LORD ARCHER OF SANDWELL: Of course.

MR O'MAHONY: And going right back to the mid-1990s, I would often be invited by the Centre (inaudible) to sit with them when they were looking at various products, but that is different to being formally involved as an organisation.

LORD ARCHER OF SANDWELL: Of course.

MR O'MAHONY: And I think it is that formal involvement that is crucially important. First of all, in Ireland it has given the patients tremendous confidence in -- when a product is changed they now say, "Okay, if you agree with this change and the National Haemophilia Director agrees with this, then I am happy if both of you agree, if you are both in the room when the decision is made".

Secondly, the formal involvement, as Roddy, I think, said earlier, means that the haemophilia societies not only have the involvement, but they have -- to get the resources they must put the right people in the room. This is not the sort of thing where you bring in a volunteer for a year. It is a long-term commitment, the person must commit to learning a lot about blood, blood products, recombinant products, technology. So therefore the formal involvement means that you now have the reason for really training people and for doing that, you know. And if it is informal, it doesn't work.

LORD ARCHER OF SANDWELL: Yes.

MR O'MAHONY: As I said, I believe that a National Haemophilia Committee should be established in the UK to include the clinician representative, the Society and the Minister for Health. I believe the Society should have a formal participation in the tender procurement process. I am aware that for many people with haemophilia in the UK, and I have spoken to people here, have difficult for paying for and accessing some health services on an ongoing basis, and I would really like to see some provisions similar to those provided in Ireland under the Health Amendment Act legislation, I think that would be very useful in alleviating the financial burden of illness.

I do not believe it is fair that any person with haemophilia who has HIV or hepatitis C through blood or blood product provided by the state, should have to worry about paying for their healthcare for any part of that condition or any condition that they develop. I would endorse the view that I would like the UK Government to look at the insurance legislation that was passed in the Ireland and look positively at making a similar provision in the UK.

I believe that adequate compensation should be paid to people with haemophilia who have been infected by hepatitis C and HIV, and that this should take account of the pain and suffering they have endured, and continue to endure, the loss of earnings and the loss of their potential, and their current and future requirements in relation to being able to provide for themselves and their families.

I also believe it should not ignore the suffering of partners and of windows of those who have died. I think it is shameful and undignified that many of the people with haemophilia and their families are in poor financial circumstances and they are reliant on discretionary payments or assistance. I know that the Macfarlane and Skipton funds have done good work and continue to do good work, but I believe that adequate compensation would give the people with haemophilia independence but also dignity.

At the moment they are being denied control over their own future, and many of them believe that they are being condemned to a life of means-tested benefits and in fact whereas I know that the Macfarlane fund and the Skipton fund have been very good it is demeaning to have to go back to a trust fund on a constant basis for financial help and assistance. At the very least, people should be offered their dignity and that is not being offered at the moment.

Finally, it is inconceivable to me that the Haemophilia Society in the UK receives so little financial support from the Government and that even this limited financial support is under threat. We have been in the happy position in Ireland that we have not taken any funding from pharmaceutical companies for the past several years, and in fact if we take any funding in the next couple of years it will be to help projects we are doing with haemophilia societies in developing countries. I believe that the Society here in the UK, because it is not getting sufficient Government funding, have to spend an inordinate amount of their time and effort in raising funding, rather than doing the work that they could be doing for people with haemophilia.

I believe it is fundamentally immoral for a government to provide medication which results in the infection of persons with life-threatening viruses and then to abandon their representative organisation, which is the only organisation which is their focus for help and support and assistance, and abandoning them is what they are doing by not providing ongoing reasonable financial resource. I hope the Inquiry in its report will urge the Government to take action in these areas and a high proportion of the haemophilia population have been directly affected by infection with hepatitis C or HIV in the UK. I think the response to date by the UK Government has been miserly and grudging and I hope, Lord Archer, your Inquiry will be the catalyst which will help to force the Government to respond with compassion and with the necessary measures which they should already have taken. Thank you.

LORD ARCHER OF SANDWELL: Thank you very much, Mr O'Mahony. (Applause). It seems you have a great deal of support for those recommendations.

MR O'MAHONY: I feel very strongly about them.

DR NORMAN JONES: I really would like to thank Mr O'Mahony for an excellent presentation, most helpful. I asked the questions I had as we went along, thank you.

MS JUDITH WILLETTS: Yes, I think I am all right. I just wondered very, very briefly, because I know you have had a long session with us, how has all this changed the community in Ireland, in terms of -- we talked a little, I think, about closure, and we have talked a bit about -- what is the perception now in perhaps how they are being treated and the progress that has been made? Is it a more satisfied community, does it feel it is a community that is very much moving forward because of its involvement and because of its now official voice? I think it might be interesting to get a little bit of a flavour of that.

MR O'MAHONY: I think in some ways a lot of the individuals with HIV and hepatitis C, and particularly parents with children who died, put a lot of faith in the Inquiry, at the end it left a bad taste in their mouth because they didn't get closure, and in fact I think for some of them closure will not be possible. You know, for them justice would be if their child was still alive, and that cannot be remedied. So in that situation you look -- this might provide the answer, this might – and in some situations closure will never be possible, the wounds will not heal.

But for the majority of people with haemophilia with HIV and hepatitis C in Ireland, I think the work of the Society, the work done before the Inquiry, the Government measures that have been taken, the formal involvement of the Society has been very, very welcome for them. They feel a much stronger sense of empowerment. They feel very much they are now partners in their own care. They are no longer told, "You have hepatitis C, you must take treatment". They are told, "These are the facts, these are the stats", we organize meetings and programmes and they make the decision with the doctor. So it is a consultation process. They are fully informed about the products they are using, and we get very large attendance at meetings if we change a product. We say, "Come along, you are going to inject this product into your child, you should understand what the product is made of", and we get a lot of attendance. There is a strong sense of empowerment, there is a much stronger sense of justice than there was in the past. The sense of constant worry about having to -- "can I afford to go to the doctor this week, can I afford to take (inaudible)" is gone. The sense of --

LORD ARCHER OF SANDWELL: Could I just -- is there a National Health Service in Ireland?

MR O'MAHONY: There is, but the provision of general practitioner services was always means tested, so you had to pay to go to see a doctor. So I think their financial worries in terms of getting treatment have disappeared. Their financial concerns in relation to being able to survive, being able to live, have largely dissipated. I think the insurance now, when it rolls on, will be a major benefit to many of them. They really feel -- many of them say "I am coping fine, I am looking at treatment options, but really it would be nice to have insurance so if something happens to me my wife and children are looked after". So it is a much more cohesive community, a much stronger community, a much more empowered community than it was 10 years ago. And I think the same -- you know, if I look back 20 years to 1985, there was anger, there was guilt, there was fear, there was stigma, there was discrimination. That has gone, and the publicity surrounding the Inquiry was hugely beneficial and the media did a superb job covering it, because we had three or four journalists from the national newspapers who covered the entire Inquiry day in, day out, and they did a superb job and really educated the public.

MS JUDITH WILLETTS: So the Irish public is possibly hugely more aware and informed than the UK public.

MR O'MAHONY: Yes, yes.

MS JUDITH WILLETTS: As a result of --

MR O'MAHONY: There is no doubt about that. In fact there was a survey carried out by a marketing company last year -- nothing to do us -- but they used haemophilia as one of the control questions, and they came back to us and said that there was a huge public understanding and awareness of haemophilia in Ireland.

DR NORMAN JONES: I think one thing that came across very clearly in your presentation, which I would totally support, is the very big potential for education in this sort of collaborative way forward that you advocate, and it is very much two way education, mutual.

MR O'MAHONY: Absolutely, and I think if you look at areas like hepatitis C treatment, where, you know, you are asking someone to take a therapy which really destroys their life for a year, with a 40% chance of success, and the success is also predicated on what they do for the year, if they take time off work, if they are able to cope with the side effects. Now, to put somebody into the situation of taking that treatment without proper informed consent and discussion is crazy, and in fact what we have found is even -- and I have spoken to a lot of the people with haemophilia in Ireland with hepatitis C who have taken treatment and interestingly those who have taken treatment who have gone through a year of misery and for whom the treatment has not worked, most of them have felt, "I still don't regret taking it, because I went in with my eyes open, we had a good discussion with the doctor and you take your chance" and I think that informed consent, that ability be involved in the decision-making process about your own health is hugely important for the individual, but also for the society. I think the general rule should be "nothing about us without us". I think if there are going to be decisions made which will affect dramatically the health of the person with haemophilia or the resources available then I think they should be involved in that process, and I think that empowerment is hugely important, and, as I said, I think the Department of Health have recognised that. They can see the clear advantage of having the patients involved.

MS JUDITH WILLETTS: And they have also benefited financially from that involvement.

MR O'MAHONY: Absolutely, and I know that last year when they introduced more stringent requirements in relation to annual funding for charities they asked us if we had any objection to using our budget and our list of programmes, so they could show these to other charities as an example of responsible use of funds. So it has been good from that point of view. Clearly the problems have not gone away, but I think they have been dealt with much more comprehensively.

LORD ARCHER OF SANDWELL: Thank you much, Mr O'Mahony. No doubt we will continue to be in touch.

MR O'MAHONY: Absolutely.

LORD ARCHER OF SANDWELL: As various issues arise.

MR O'MAHONY: I am going to send you the quote from the minister in Parliament, the apology.

LORD ARCHER OF SANDWELL: Thank you.

(3.24 pm)

(The hearing adjourned until 19th September 2007)

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