Health and Community Care Committee, 25 Oct 2000

Meeting date: Wednesday, October 25, 2000

Official Report 229KB pdf

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Hepatitis C

We will move on to the next item. Minister, do you want to make a statement on hepatitis C, or do you wish to go directly to questions?

I am happy to go directly to questions.

Although I am persuaded that there has been no negligence on this issue, people have fastened on to the September 1986 preliminary report from England that indicated that heat treatment of blood products might prevent transmission of the disease. I can advance several answers on that issue myself; however, as I am here to ask the questions, I will give you the opportunity to respond to that point. As far as I am concerned, that is the only section of your report on hepatitis C and heat treatment of blood products that requires to be questioned.

I am grateful to Malcolm Chisholm for his question. He has rightly focused on one of the key elements of our report and the investigation that I commissioned. Although I have waived my right to an opening statement, I would like to make a few wider points in answer to Malcolm Chisholm.

First, I am profoundly aware of the impact of this experience on individuals and their families and have enormous concern and sympathy for those who have been affected. That is precisely why I wanted to investigate this issue carefully and examine the facts fully. Our report seeks to address the specific question raised with me last year—whether the Scottish National Blood Transfusion Service could have or ought to have done anything else in the mid to late 1980s to reduce the risk of hepatitis C infection to haemophiliacs in Scotland. As the committee might recall, it has been suggested that the SNBTS could have or should have introduced heat treatment procedures for factor VIII at an earlier stage, which could have rendered that blood product safe.

The report gives the detailed chronology. During that period, work was going on in different laboratories—not only in the United Kingdom but right across the world—to make blood and blood products safer in a range of ways. HIV was isolated in 1983 and, as we all recall, extensive investigation and research followed as a consequence. Each laboratory made progress at different rates. The hepatitis C virus was not recognised or isolated until 1989. Prior to that, there had been developments that subsequently turned out to be effective in dealing with the hepatitis C virus in blood.

Our findings, which are fully set out in the report, tell us that as soon as action to make factor VIII safe was possible, it was taken. In 1988, Scotland became the first country to have that process fully in place, although we recognise that England started in this area before Scotland. We do not believe that SNBTS could have done anything more than it did, given the level of scientific and medical knowledge at that time.

I note in the report that Scotland produced trial batches of factor VIII that had been treated at 80 deg C before September 1986. Would clinical trials have had to be done, meaning that early 1987 would have been the earliest possible time for its use?

Absolutely—that is why we have set out the chronology of events in some detail in the report. A development process goes on, in research and clinical trials, for different treatments for blood and blood products. That is not just about finding a treatment that kills a particular virus; it is also about ensuring that the blood product is still safe and effective. There were clinical trials during that period.

As you say, different laboratories and different scientists were working on different strands of the same issue. To some extent, they concentrated on HIV. Did the SNBTS have its eye on the HIV ball—if you like—rather than the hepatitis C ball? In doing that, and in using pasteurisation and wet heat rather than dry heat, did it commit itself to going down that route while others were doing other things? When it changed to using dry heat, did it have to move away from a course of action in which it had invested time and effort? How do different laboratories across the world talk to each other about their developing work?

I do not agree that SNBTS focused simply on HIV. When we consider the history of this—and we must bear in mind the fact that we are going back 15 or 20 years—the medical and scientific research community was spurred on by the drive to eliminate HIV. That resulted in a far greater investment of skills, expertise and resources during that period to examine how scientific knowledge, technical expertise and treatment and testing methods could be developed most effectively.

Throughout that period, there was an awareness of the existence of another unknown virus, which was known as non-A, non-B hepatitis, which was not recognised or isolated until 1989. In retrospect, it became apparent that various heat treatments that had been tested and developed for other reasons at that time could be effective in killing that particular virus. Subsequently, arrangements were put in place.

There is a barrage of hands. I want to stay on the technicalities of the issue before we move on. Members must stick to the technicalities.

In that case, I hope that I will be allowed in again to ask my other question.

Minister, will you confirm that the 68 deg C heating, which was the technology that was proved, was not proven to be effective against HIV until after the new 80 deg C technology became effective? People did not know whether the 68 deg C technology would work—that was the problem. The whole industry, across the world, was driving to get higher temperatures with longer periods of heating to ensure that whatever was there was killed. That is why there was such a significant difficulty.

Are you happy to agree with that, minister?

Yes.

I lived through the 1980s—

I think we all did—even Duncan Hamilton.

I clearly remember being involved with the people who were clamouring for a heat treatment centre in Scotland. The concern was HIV, not hep C, which, as the minister correctly says, was not recognised until 1989. However, people realised that they had something exceedingly dangerous on their hands and that, often, another virus was involved. I also remember that the sums of money involved came to only a few hundred thousand pounds and that Scots pleaded with the Conservative Government to give them that to conduct the heat treatment. How can the Government today body swerve the tragedy that has occurred due to hep C subsequent to the HIV tragedy? Will the minister at least consider ex gratia payments to the families?

Would those be technical ex gratia payments, Dorothy-Grace? I really do not think that that was a technical question. Other people are waiting to ask non-technical questions.

People are suffering, Margaret.

I know. The minister may answer the question.

Do you want me to answer Dorothy-Grace Elder's question now, convener?

Yes.

Members are asking a range of technical questions, many of which, I hope, are addressed in the report. If the committee wants to take it up, the offer remains for one of our medical advisers or perhaps the deputy chief medical officer, who was involved in the report, to come along to discuss the matter further.

Dorothy-Grace Elder referred to ex gratia payments. Compensation has been discussed quite fully. Let me differentiate between negligent and non-negligent harm. The essence of the report was to investigate whether there had been negligence during the period in question, which would require the NHS to pay compensation on the ground of harm having resulted as a consequence of negligence.

Having examined the information carefully, we have found no evidence to suggest that there was negligence, for the reasons that we have outlined and, as Richard Simpson indicated, because of the chronology of events and when medical and scientific knowledge advanced.

There is also the question of non-negligent harm. The NHS not paying compensation for non-negligent harm has been a generally held principle. That was revisited in these cases, two years ago by the UK Government, by previous Conservative Governments and now by the Scottish Executive.

Having examined the issue we do not see there being a case to change that principle in this instance. I am bound to say that all medical treatment carries a degree of risk. The issue is about the balance of risk and how we deal with it.

We are not talking about treatment.

Let the minister finish.

I am happy to take a further point from Dorothy-Grace Elder.

But I am not. Nicola Sturgeon also has points to make on this issue.

I have two points. First, the report that is before us today is, in effect, an internal report by the Scottish Executive into one of its agencies. Considerable disquiet and controversy surround its findings. In light of that, will the minister consider the case for a public inquiry, which has been supported by a significant number of members of this Parliament, so that evidence can be taken and conclusions formulated independently and openly?

Secondly, I will return to Dorothy-Grace Elder's point. I am sure that all of us who have read the report are aware of the distinction between negligent and non-negligent harm. If we can put the issue of negligence aside for the moment, will you reconsider awarding no-fault compensation, perhaps along the lines of that announced for CJD victims in England? If you are not prepared to do that, can you outline the distinction between people who have been infected with hepatitis C through infected blood products and the CJD victims—why does one group deserve no-fault compensation while the other does not?

There has been no formal announcement on variant CJD cases in England. The report of the Phillips inquiry into BSE is due for publication tomorrow. None of us can comment, either on that report or on any of the Government—

If it is the case—

I do not think that we can deal with conjecture, speculation and hypothetical situations. We must deal with the facts in every case. As we know, the cases of variant CJD are also enormous human tragedies. The BSE issue has been examined in the detail that it has been to inform us better why the situation occurred. We will need to examine that report when it is published. We must examine every case on the basis of the facts and the circumstances.

Nicola Sturgeon asked whether I would change my view, or whether I would respond to calls for a full public inquiry. Several members, including Nicola Sturgeon, have called repeatedly for me to order full public inquiries on several issues. I understand why people want that to happen on complex issues, but I must reach a judgment about the appropriate level of investigation, inquiry, examination and intervention that is required in any case.

I gave a commitment to the Haemophilia Society and others that, as a new Executive and as the new Minister for Health and Community Care, we would take a fresh look at the facts of this case. I have done that thoroughly. The report that has been published sets that out openly. That indicates, as does the fact that we are discussing the matter at this meeting, that in a devolved Scotland we have far greater opportunity to do such things openly. I do not believe that it would be appropriate to have further investigation of what happened 10, 15 or 20 years ago. We have set out the facts.

I am not aware of anybody challenging the substantive facts in this case. What is crucial is that we all think about what we can do in future, not just for the haemophiliacs who have been infected with hepatitis C, but for the growing number of Scots who are infected with it.

Haemophiliacs who have been infected by hepatitis C desperately want to look to the future. Do you accept that an inquiry that has, in effect, been carried out by your department into one of your agencies does not inspire the full confidence that an independent inquiry would? I had a call on the matter from someone this morning—perhaps you can answer their questions. Was evidence taken from immunologists, liver specialists and so on? Exactly what evidence was taken and what weight was given to it?

I return to my original point: there will always be difficulty with the findings of a report that has been carried out in such circumstances. Would not it be better for all concerned—your department included—if a genuinely open and independent inquiry could be held?

The inquiries were initiated to establish the facts. How those facts were found and who was asked to provide information is set out fully in the report. All the submissions—apart from those where the people who submitted them said that they did not want them to be made public—are available for scrutiny. I am unaware of anyone having challenged the substantive facts in the report.

Of course it is open to people to continue to discuss the issue. It is open to the committee to do that and to take further evidence. I state to you candidly that a judgment that I have to make regularly—and have made in this case—concerns the extent to which we take lessons from the past and apply them to the future. We have struck an appropriate balance in this case.

The minister is correct. We have two petitions, one on the factor VIII blood products situation as it affects haemophiliacs in Scotland, and one on the wider issue of compensation for people who have been infected by hepatitis C as a result of other NHS treatment. The committee has an on-going job in both regards. It is for us to decide what further work we do on hepatitis C. We can do all sorts of different things—committee members are well aware of our abilities in that respect. We will return to the issue in the near future and decide what action we should take and whether we should take further evidence from other groups on the report and the wider issue of hepatitis C.

First, will you consider expanding the Macfarlane Trust to encompass hepatitis C? I know that you did not want to hypothesise on CJD, but the trust, which was set up under the Conservatives, was intended to help people with HIV. Secondly, will you assure us that the inquiry was independent and tell us whether any officials who were involved in the inquiry were also involved in the decisions that were made in the early 1980s?

On Ben Wallace's first question, I adhere to the view that has been held by successive Governments—Labour and Conservative. Having considered the issue and the cases, I do not see an argument for veering from the general principle of not offering compensation in the case of non-negligent harm. I recognise that a previous decision was taken on the Macfarlane Trust.

On the second point, I stress that the report was a fact-finding exercise. To the best of my knowledge—and not least because of the time that had elapsed—the officials who were most closely involved in carrying out that exercise for me were not directly involved in the details of that earlier period.

I emphasise that we were gathering the facts and, as I said in response to Nicola Sturgeon's questions, all that information is available for the committee to scrutinise.

Do you think that the Macfarlane Trust should not exist because it does not adhere to the principle that has been followed by successive Governments?

I would also like a stronger assurance—

The first question is not one that I would want the minister to be asked—it is not relevant to the discussion. The minister has answered a question on the relevant points.

We are running over time and five other members want to ask questions. You can ask your second question, Ben.

Will the minister investigate whether the officials who were involved in the fact-finding inquiry were involved in the original process? Will she write to the committee on that point, so that we can satisfy ourselves that they were not?

I repeat: it was a fact-finding exercise. Only if someone were to question the validity of the facts would I have grounds to call into question the process by which the facts were gathered. On the basis of the information that has been presented to me, I have no reason to do that. All that information is available to committee members and others.

Can I ask about compensation?

No.

I want to move on. I hope that any member of the public who listens to today's meeting or reads the Official Report will examine the full evidence, including the supplementary report, which contains all the evidence apart from letters from the haemophiliacs—which they did not want to be published—so that any questions can be posed to the Health and Community Care Committee as part of its work on the petitions. Unless there are direct questions about that evidence, I agree with the minister that, at this stage, there is no purpose in spending public money on a public inquiry.

Keith Raffan has questioned the minister closely on several occasions on the whole issue of hepatitis C. Has it been decided whether a Scottish needs assessment programme—SNAP—report on hepatitis C will be undertaken? If the minister feels that such a report is appropriate, will she try to ensure that it is produced on a broader basis, to examine the social and support issues that relate to the management of hepatitis C, both for haemophiliacs and others? That might be an alternative to the Macfarlane Trust or compensation, both of which seem to have been ruled out.

It is important to look to the future and, where we can, to learn lessons from the past. The incidence of hepatitis C has been rising steadily in Scotland and that is an enormous cause for concern. Various members have raised the issue with me. That is why SNAP was commissioned to carry out a comprehensive piece of work to investigate how the needs of people with hepatitis C could be met more effectively and to address issues of infection and prevention. The report was published at the end of last month and is being given careful consideration. SNAP reports are issued routinely to health boards. However, because of the level of incidence of hepatitis C in Scotland, I want to ensure that we consider the report thoroughly to ascertain what further steps we can take to improve services in the future.

I am minded to extend our time on this item a little, as I am aware that it is important. A number of members have indicated that they wish to ask questions.

Given that this is an emotive issue that has had a tragic effect on people's lives, it is not surprising that the Haemophilia Society has said that your report contradicts its evidence and is thin and incomplete. I have looked through the report—not as thoroughly as I would have liked to, as I was preparing my speech for this afternoon's debate—and it seems to me to be a substantive piece of evidence. Would any further inquiry be likely to yield more information that would contradict empirically anything that was said in the report that was issued yesterday?

Of all the evidence that I have seen, nothing leads me to conclude that further examination of this period would reveal substantial additional information or would enable us to do anything differently.

As Mary Scanlon said, this is an emotive subject. I have met people who have been affected by what has happened, just as on a regular basis I meet people who are affected by a range of conditions. We are looking to do the best we can to assist people. We cannot turn the clock back to avoid the tragic cases occurring but, as Richard Simpson's previous question indicated, I hope we can at least attempt to support people with hepatitis C more effectively in the future. We will also continue to ensure that blood and blood products that are offered in Scotland are made as safe as possible, to prevent the transmission not just of viruses that are known now but of viruses that may be identified in future.

I want to pick up on one of the issues that the Haemophilia Society is still unhappy about and that Mary Scanlon touched on. You have outlined the time scale for certain scientific discoveries and changes. However, there is a wider issue of whether patients were given appropriate information, which is much more difficult to pin down. We all know that during the 1970s scientists knew that hepatitis C existed, but did not know what to call it. In the 1980s, patients and patient groups had access to a certain amount of information. However, that is not the same as saying that each patient and their family were given all the information that they required to make the best judgment. Are you convinced that patients were given all the information that they could have been given in the circumstances?

That was the second part of the question that this exercise was designed to answer, as haemophiliacs and their families had raised the issue of provision of information with us. We found it particularly difficult to access information about that, but in the latter part of the report we have detailed what we were able to find out about the amount of information that was issued to patients and their families, based on the knowledge of the condition that existed at the time.

From the facts that we have been able to establish and the information that we have been able to uncover, it would seem that substantial efforts were made to make available to people information about the risks that existed. It is important that we seek continually to ensure that patients, now and in the future, are given as much information as possible, to enable them to make informed choices. There can be no absolute guarantees or certainty.

As I said earlier, medical treatment always carries a degree of risk. It is important that we identify that risk and communicate it as effectively as possible to patients.

I welcome the fact that we have access to a lot of information that did not appear to be in the public domain previously. However, many people are still unhappy that there will be no public inquiry into the matter. In light of that, is the minister prepared to meet the Haemophilia Society to address the outstanding concerns that it might have following publication of the report? Could the minister tell us why publication of the report was delayed?

On compensation, I understand that the minister cannot take hepatitis C away from sufferers, but can she explain the logic of the distinction that has been drawn between people who have been infected, as a result of contaminated blood products, with HIV and hepatitis C?

Both HIV and hepatitis C are emotive subjects, but when HIV first arose, the life expectancy of sufferers was significantly shorter than is the case today. Hepatitis C might have a similar effect to HIV on morbidity and mortality.

I know that Brian Adam has taken a close interest in this issue. I think that his last point partly answered itself.

When the Macfarlane Trust was established, the distinction that was made for those with HIV was based on a judgment call made by the Administration at that time, for which I cannot answer. Brian Adam touched on a number of points. HIV was an extremely emotive issue during that period; the life expectancy of people with HIV was considered to be very short and that was a material factor in the judgment that was arrived at by the Government of the day. Of course, that same Government also chose to make a different judgment call in relation to other conditions, including haemophiliacs who contracted hepatitis C.

Completing and publishing the report took much longer than I thought it would take when we set out on this exercise, partly because it proved difficult to access information that went back 10, 15 or 20 years. We worked hard to obtain that information, and I hope that it is helpful that the information is now available in the public domain.

I wanted to satisfy myself on the contents of the report before I put it in the public domain. When I received the report, I asked a range of further questions and for further information and details on the chronology of events to be included, as I wanted to be sure that we had considered all the facts and that the report was robust.

Publication of the report took longer than we hoped because we wanted to get it right and to ensure that the report was reliable, so that people could depend on its accuracy.

I met the Haemophilia Society previously and I am happy to meet it again to discuss either outstanding issues arising from the report or wider issues that the society may wish to raise.

We are overrunning, but I have only Hugh Henry's question left. Hugh, has your question been answered?

Yes.