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The Deputy Speaker (Baroness Turner of Camden): My Lords, I must inform noble Lords that if Amendment No. 21 is agreed to because of pre-emption I cannot call Amendment No. 22.

Baroness Young of Old Scone: My Lords, I add my support to Amendment No. 21. I welcome the extension of the exclusion to 72 hours with respect to minor infringements in Schedule 2. The amendment provides a more substantial exclusion which is a serious deterrent and a demonstration, which is otherwise missing, that infringements are regarded with a degree of seriousness. There are other issues about penalties which the 72-hour exclusion does not meet, and I intend to deal with those in Amendments Nos. 23 and 25. However, I thank the Minister for going as far as he has.

Lord Mancroft: My Lords, I join the noble Baroness, Lady Young, in thanking the Government for tabling this amendment and recognising the issues concerning sanctions that I and my noble friends raised at Committee stage. Undoubtedly, a 72-hour exclusion period is a great improvement on 24 hours because it extends over the long weekend, and we are grateful to the Government for taking that step. It would be helpful if the steps went slightly further, but one can perhaps always say that. However, my noble friend's amendment is a further step in the right direction.

I take on board the Minister's observation that to ban people from all access land for 72 hours may be unenforceable. All such sanctions carry with them the possibility of unenforceability. However, if a 72-hour exclusion from all access land is unenforceable, the reality is that all the sanctions under the Bill, and the rules and regulations attached to them, are also unenforceable. The real problem with this Bill is not the theory behind it but its enforceability (if that is the right word) and how it will work on the ground. Therefore, the greatest concern is that the charge of unenforceability can be levelled at virtually every area of the Bill. Nevertheless, on this occasion I thank the Minister for tabling the amendment.

Baroness Miller of Chilthorne Domer: My Lords, we on these Benches also warmly welcome the Government's move in this direction, for which we pressed in Committee.

Baroness Byford: My Lords, I beg leave to withdraw Amendment No. 21A.

Amendment No. 21A, as an amendment to Amendment No. 21, by leave, withdrawn.

Lord McIntosh of Haringey: My Lords, in moving Amendment No. 21 I should have spoken also to Amendment No. 27 which is purely consequential. I shall move that amendment when we reach the

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appropriate point. In addition, the noble Lord, Lord Mancroft, should not think that this is a further step in any direction as far as concerns the Government.

On Question, Amendment No. 21 agreed to.

[Amendment No. 22 not moved.]

Lord Burlison: My Lords, I beg to move that consideration on Report be now adjourned. In moving this Motion, I suggest that Report stage begin again not before 8.35 p.m.

Moved accordingly, and, on Question, Motion agreed to.

Hepatitis C

7.35 p.m.

Earl Howe rose to ask Her Majesty's Government what plans they have to improve the care and treatment of patients with hepatitis C.

The noble Earl said: My Lords, this Question has been triggered by a series of briefings given to me recently by the British Liver Trust. Its work, together with some academic research to which I have had private access, leads me to conclude that there is a great deal to be done before the service provided by the NHS to patients with hepatitis C, or to those who are suspected of having it, can be considered in any way satisfactory.

I begin with some factual background. Hepatitis C is what might be termed a "new" disease. As a virus it was separately identified only in 1989, although it is known to have existed in various parts of the world long before that. The World Health Organisation estimates that more than 170 million people worldwide may be infected with it. In Asia and parts of Africa, and especially in Egypt, its prevalence is 10 per cent or more. In the UK the best and most recent estimates are that it affects approximately 0.7 per cent of the population, equal to perhaps 400,000 people. That figure is only a rough guess based on extrapolations. The true figure could be lower or, more likely, a great deal higher. I shall return to that issue in a moment.

The hepatitis C virus, or HCV, is a blood-borne infection. There are thought to be at least six strains of the virus, each with sub-strains numbering about 40. Over the course of time these strains may change spontaneously. It is partly for this reason that to date no vaccine for hepatitis C has been developed. It is commonly agreed that the largest single transmission route is through intravenous drug misuse. There are, however, many others, including transfusions of contaminated blood before the introduction of screening procedures and maternal transmission in pregnancy. HCV, therefore, cuts right across the social spectrum. In prisons where the incidence of HCV is especially high, transmission occurs not only through the re-use of needles among drug-users but also from the sharing of items such as razors and toothbrushes which may draw blood.

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The incubation period of the disease is long. A large percentage of people who develop hepatitis C today are in their 40s and will probably have contracted it 20 or more years ago. It is this feature of HCV which is particularly significant in terms of healthcare planning. Even if all the routes of transmission were somehow to be closed off tomorrow, we would still face the prospect of large numbers of cases emerging over the next 10 to 20 years.

What implications does this have for the NHS? The good news, such as it is, is that hepatitis C is by no means always fatal. Indeed in 20 per cent of cases it disappears spontaneously. However, in the other 80 per cent of cases, the vast majority of those infected will go on to develop a long-term chronic illness. Some 20 per cent will contract cirrhosis of the liver, and of those half will develop liver cancer. Even among those less severely affected the symptoms of the disease can be debilitating--fatigue, depression, lethargy and a resultant poor quality of life are common. If, as some specialists predict, we can expect to see many hundreds of thousands of people needing treatment for hepatitis C over the next decade, the costs to the National Health Service are likely to be significant.

Combination therapy, involving Interferon and Ribavirin, costs some £9,600 per annum per patient. Although it is able to cure up to 40 per cent of patients, the majority of health authorities either do not provide it at all or provide it on a limited and inadequate scale. Indeed, in a survey conducted by the British Liver Trust in 1998, it was found that only a fifth of health authorities had any sort of strategy for tackling HCV, and fewer than one third had a budget for treating it.

The postcode lottery is therefore alive and kicking with hepatitis C. In part, that is a simple reflection of inadequate funding. It is also explained by uncertainty among GPs and health authorities about the cost-effectiveness of combination therapy. That uncertainty should now to be banished in the light of the guidance published this week by NICE. The NICE guidance, though effectively only re-stating the established evidence about the clinical effectiveness of combination treatment, is nevertheless very welcome.

What are at stake, of course, are not simply the direct benefits that combination therapy can bring to patients. Timely drug treatment reduces the long-term costs of care. In particular, it can reduce the need for liver transplants, which can cost up to £50,000 per patient, excluding follow-up medication. It also mitigates the high cost of providing care for patients who develop advanced liver disease and associated complications. It is disappointing that these issues appear not to have been examined by NICE as part of their evaluation.

The idea, however, that the NICE guidance will somehow solve the postcode lottery is, I fear, over-optimistic. Health authorities will still need to prioritise funding to meet the cost of treatment. Those costs have been estimated by NICE at £18 million per annum initially. That figure excludes the associated costs for pathology, virology, radiology and specialist nursing. The verdict of every reputable HCV specialist

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is that spending money early will save a great deal more money later. Yet we have to ask what incentive a health authority has to invest those very considerable sums. One deterrent, incidentally, is that the costs of liver transplants, unlike combination treatment, are funded centrally.

On this side of the House we believe that the barrier to funding relatively expensive drug therapies such as Interferon alpha and Ribavirin could be eliminated by the creation of a central funding mechanism for such exceptional medicines, quite separate from health authority budgets. But if that is not to happen, then the very least that is needed is clear guidance from government to health authorities to make the therapy widely available.

But therapy is only one aspect of the problem. There is a woeful lack of proper facilities in many areas to test and counsel HCV patients. There is no common protocol to which health authorities work in looking after and managing such patients, both before and after testing. One important improvement, mentioned by NICE, would be the wider availability of confidential testing facilities, of the kind that currently exist for HIV. It is thought that many people are deterred from seeking a test for HCV because it will feature on their medical record. That in turn will stigmatise them in their prospects for employment, life insurance and a mortgage. It will also have an effect on personal relationships. As a result it is likely that many people whose condition could otherwise be arrested are not even being diagnosed.

Just as there is no uniform pattern throughout the country in the provision of testing facilities, so too there are very varied procedures followed for the counselling of patients. The way in which patients are presented with their test results is often insensitive and ill-thought through in the extreme. A great many receive no advance preparation for what they are about to hear and no advice about it afterwards. When so much is at stake, that cannot be a satisfactory way of proceeding. As NICE says explicitly in paragraph 5.21:


    "Confidential HCV testing and counselling should be made available whether or not treatment is initiated."

The other area crying out for funding is research. There is much about HCV that remains unknown. Some aspects of the pathogenesis of HCV are still hidden. The precise mechanisms by which HCV causes liver cancer have not been identified. We still need a simple, cost-effective and reliable diagnostic assay test, both for the initial detection of HCV and for monitoring the disease as it progresses. There are still no firm data on the susceptibility of HCV to disinfecting agents, which is important bearing in mind that the virus, unlike HIV for example, can survive many hours outside the body. Perhaps the Minister can tell the House what research is currently being conducted in any of those areas.

It is all too easy to stand in your Lordships' House and sound alarmist. I never have any wish to do that. Nevertheless, when medical experts tell us that, "We are poised on the brink of an epidemic, which could have far wider ranging implications than AIDS", we

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have a duty to pay close attention. Those were the recent words of Dr William Rosenberg, senior lecturer in medicine and consultant physician at Southampton General Hospital and the University of Southampton.

There are other experts who predict that in two or three years' time, hepatitis C will outstrip AIDS as the most common cause of death in early and mid-life. The NHS needs not just guidance from NICE but a co-ordinated strategy. Variations in facilities and inappropriate management procedures need to be ironed out.

To that end, I would welcome the Minister's comments on the merits of trying to devise a national protocol for the management of HCV, building on the NICE guidance; perhaps in the first instance by adopting the guidelines issued by the European Association for the Study of the Liver. A linked, but separate, strategy needs to be adopted in the Prison Service. Overarching all of that, there has to be a clear policy on educating the public about the risks of HCV and about prevention.

All this amounts to a great deal. I make no apology for listing what needs to be done, because the gaps in the provision of services are currently wide. But I hope, at the very least, that the Minister will say that he shares my perception of this issue as one of the most pressing and least well-resourced of any now facing the National Health Service. I dare to hope, too, that this debate will serve to add impetus to the Government's efforts to iron out those inequalities in healthcare provision on which the Minister and his colleagues have rightly laid such emphasis.

7.48 p.m.

Baroness Masham of Ilton: My Lords, I am grateful to the noble Earl, Lord Howe, for giving your Lordships the opportunity of discussing the hepatitis C virus tonight, and for the noble Earl's most informative speech.

When I said to one of the Doorkeepers last night that we would be discussing HCV tonight, he said, "I know A and B, but what is C?" Does the Minister think that there should be more health education on this subject? Should not the public be made more aware of this worldwide virus? Prevention is better than cure, as cure seems difficult.

There are many injecting drug addicts past and present who are HCV positive. People who go in for body piercing and tattooing can also be at risk. All health workers involved with taking blood or working with needles are at risk of needle stick infection. HCV can lie in the body for up to 30 years and therefore positive people can be at risk of infecting others. Can the Minister tell the House what development and progress there is on a vaccine for HCV?

When I broke my back and had a severe internal haemorrhage, I had several blood transfusions, for which I was very grateful as they saved my life. Years later I had to have blood transfusions again, and the third time it was discovered that my blood group had changed from negative to positive. I can assure your Lordships that I was very uneasy when that happened.

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The last transfusion I had was around the time when HIV presented in the UK and hepatitis C was being recognised. Some years later, because I had had blood, I requested a blood test for HCV. It was not an easy process. The nurse involved asked me what I would do if I was positive. I told her, "At least I would know". I hope that the process of testing and counselling has improved.

From what I have heard there seems to be no national strategy for dealing with hepatitis C and no national guidelines on the management and treatment of those infected. This complete lack of planning of HCV services throughout the UK results in very variable standards of management and care after diagnosis for any patient with hepatitis C. In some areas of the UK patients have to wait months or years with hepatitis C to see a hepatologist or HCV specialist and there are very few counselling and support services.

Hepatitis C is difficult to treat. Interferon and Ribavirin combination therapy was licensed last year and has been shown to clear the virus in about 30 per cent of cases. It is a highly unpleasant treatment to take, however, and the decision to start therapy seems never an easy one. Currently, many health authorities are denying the treatment to people with HCV on funding grounds, thus removing any hope of a cure.

With so many difficult problems facing our National Health Service, particularly the shortage of skilled staff, can the Minister say how the National Blood Service is coping? Has it enough skilled technicians and doctors to ensure that blood and blood products are safe from viruses such as HCV? Are the Government planning a review of the services so that the public will have confidence in this vitally important area?

I know a charming man who is a haemophiliac with HCV. He is married, working and has three young children and is taking part in trials. Can the Minister give an update on the drug trials and say which are the most successful combination therapies with as few side effects as possible? Is it a fact that the response is four times higher with Interferon Alpha with polyethylene glycol than other combinations? Does the noble Lord agree that NICE should make it clear that its conclusions may not be appropriate in the face of new therapeutic agents?

A recent European statement recommended that combination therapies should be offered to all previously untreated individuals, provided they had no contra-indications. It came from the International Consensus Conference on Hepatitis C in Paris in 1999. Does the Minister believe, like others do, that each health authority should work to a protocol in respect of the way it handles patients with HCV? Will the Government send out guidelines so that the services for patients with hepatitis C virus is a truly national one?

Tonight we are talking about patients with a serious condition resulting in haemolytic anaemia, fatigue, flu-like symptoms, bone marrow suppression and liver

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cancer and liver function failure. I hope that this debate will do something to help to improve their care and treatment.

7.55 p.m.

Lord Colwyn: My Lords, my noble friend Lord Howe has raised an important issue. As he said, hepatitis C virus infection is widespread, with an estimated 3 per cent of the world population being infected. Acute infection is usually mild but chronicity develops in as many as 70 per cent of patients, of whom 20 per cent will eventually develop cirrhosis and between 1 and 4 per cent will develop hepatocellular carcinoma.

The virus has become a major issue with the media, with the focus on haemophiliacs and whether or not HCV testing in blood donors was delayed unnecessarily. But that is not the issue in this debate. Like the AIDS virus, hepatitis C virus has an imagined stigma. Some say that it is a dangerous virus on the loose, yet others say that its effects on the liver progress only very slowly and infection is asymptomatic in most patients. Many who are infected may never be detected and diagnosis is difficult as the concentration of HCV antigens in the sera of patients is so low that testing has to be undertaken in specialist referral centres.

Groups of people who are at high risk of hepatitis C infection are well defined. As I have just mentioned, haemophiliacs have an 80 per cent risk, followed by IV drug abusers at 50 to 75 per cent and haemodialysis patients at 2 to 5 per cent. There are also patients in high risk countries and patients who have multiple transfusions.

Although I am concerned that the diagnosis and treatment for patients with hepatitis C should be of the highest priority, I have a more selfish attitude in that I am equally concerned about the risk to healthcare workers who will be treating infected patients, largely without any knowledge of that infection. I declare my interest as a practising dentist working with patients who may indeed have hepatitis C. Research has shown that dentists who have not been immunised are three times more likely to acquire HBV infection than the general population and that non-immune surgeons are six times more likely to acquire the infection than is the case in the general population.

The risk to healthcare workers is low, but annually between 2 and 4 per cent of new HCV infections occur in this group. The first known case of occupational mucosal transmission of HCV involved a nurse who was splashed in the face and eyes by blood. HCV has been detected in the saliva of patients with chronic hepatitis who are undergoing dental treatment. There is a report of HCV being transmitted by saliva in a human bite. But there is little epidemiological data to suggest that saliva is a major mode of transmission. However, I am delighted to be able to say that studies show that the risk of HCV infection through the practice of dentistry generally is low.

The incidence of sero-conversion to HCV after needle stick injury exposure to HCV-infected blood ranges from 0 to 10 per cent and averages at about

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2 per cent. I do not know what the average number of needle stick injuries to dentists and doctors is in this country, but I suppose that it happens to me about once a year. Sadly, rubber gloves are no protection against some of the instruments and needles that we use.

Currently, there is no vaccine for HCV and the chance of developing one is complicated by the virus's diversity and ability to mutate. Perhaps I may follow up the question of the noble Baroness, Lady Masham, and ask whether the Minister can update us on any of the latest work in this field.

The problem posed to the dental team for care of HCV patients is twofold. First, the prevention of the transmission of HCV from patients who knowingly or unknowingly are carriers of the virus to other patients, staff and dentists in the dental care setting and, secondly, the management of the patient with a degree of impaired hepatic function--however rare this may be.

The vast majority--probably all practising dentists in the UK--are aware that all patients present some potential infectious risk. Many patients are unaware of their condition and cannot be reliably identified by even the most comprehensive medical history. In view of this, a system of dental delivery is adopted for all patients which prevents the possibility of disease transmission in the dental environment. Recommendations on the prevention of cross infection are issued by the General Dental Council, the British Dental Association and the indemnity providers, of one of which I have the honour to be chairman.

I hope that the Minister will take this opportunity to reassure dentists and other healthcare workers that, with efficient cross infection control, it is most unlikely that there would be any transfer of the virus and that it is perfectly safe to treat patients with hepatitis C. This morning, I happened to see Professor Roger Williams, who asked me to stress this point. It is extremely important.

Patients who do have impaired hepatic function should be treated following consultation with their general medical practitioner as there are possibilities of a potential for post-operative bleeding and for the interaction of some commonly used drugs which are metabolised in the liver.

I am sure that the Minister will confirm the announcement by NICE, which I read in The Times this morning, that patients with HCV--and I presume this applies only to those with symptoms of liver damage--will be able to be treated with Ribavirin and Interferon alpha within the NHS. Sadly, there is a long list of contraindications for Interferon treatment and it is probable that those patients most likely to respond are those least likely to need immediate treatment.

A recent survey of patients with HCV in south Australia, published in the Australian Dental Journal this year, shows that there is a marked discrepancy between the oral health of those infected and a comparison group. I shall not go into the details of the various dental problems, but there is certainly a need

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for priority delivery of dental care which must incorporate a strong preventive programme and oral health education component in order to sustain health improvement. I am sure that the Minister will be able to confirm that the dental strategy has taken these priorities into account. As we passed in the corridor earlier, the Minister asked me to endorse the dental strategy. Of course I endorse it and I hope that it will deliver exactly what we are asking for this evening.

In conclusion, as a member of the Science and Technology sub-committee looking at complementary and alternative medicine and with my head full of information about homeopathics and herbal medicines, perhaps I may mention the relevance of natural medicine to patients with HCV. Despite longstanding scepticism towards the value of vitamin supplements on the part of the conventional medical establishment, there is currently a shift towards acceptance of the need for patients with illnesses such as HCV to take supplements to address proven likely deficiencies.

The use of botanicals can offer tissue support, the prevention of necrosis of liver cells, provide alternative pathways of metabolism to circumvent inflammation and boost the immune system. Particular botanical phyto-chemical constituents such as silymarin from the milk thistle plant have demonstrated an ability to inhibit viral reproduction, support the immune system and regenerate hepatic cells. I thought that the Minister would like to have that information!

8.4 p.m.

Lord Turnberg: My Lords, I am most grateful to noble Lords for allowing me to speak at this point in the debate and, of course, I am grateful to the noble Earl, Lord Howe, for bringing forward this important matter in the House. I understand that I am allowed to make only one point in the two or three minutes which I have been given. I wish therefore simply to stress the importance of prevention in the control of this disease.

Preventive measures do work. We have seen already that transmission of the disease through blood transfusions and blood products has been virtually eradicated by testing blood donors. We also have good evidence that needle exchange schemes reduce quite markedly transmission among intravenous drug abusers. But here the record is not nearly so good. Experience in other countries suggests that we could do much better here if we invested more in needle exchange schemes, a point which I am sure that my noble friend will take on board.

There are preventive measures which can be taken to reduce transmission of the virus from infected mothers to their babies at birth. This requires surveillance and testing of at-risk mothers in the ante-natal period and the use of precautionary efforts at the time of birth.

I should say, also, that if we agree that prevention is important--as I am sure noble Lords will--then we must know more about the prevalence of the infection in the at-risk population. How else would we know where to focus our efforts? I speak here from the perspective of chairman of the Public Health

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Laboratory Service Board, an interest that I should declare. Although testing and surveillance of the at-risk population is cheap compared with the costs of treatment, funding for surveillance would be money well spent and deserves the investment that is needed if we are to manage this disease optimally.

A part of that surveillance testing is the increasing requirement to test for specific sub-types or genotypes of the virus, each of which has somewhat different clinical effects and plays an important part in determining the length of time for which patients need treatment. All of that speaks for the need for high quality genotype testing and surveillance at both local and national levels as an important part of the prevention and treatment of hepatitis C disease. I hope that my noble friend will agree with that.

8.7 p.m.

Lord Clement-Jones: My Lords, I, too, congratulate the noble Earl, Lord Howe, on raising the issue of HCV in this debate tonight. At the same time I should like to pay tribute to C Change and Action on Hepatitis C, who have done so much to move the subject of HCV up the political agenda. We have heard four extremely authoritative speeches. An extremely cogent case has been made out in a number of areas related to HCV. All that I can do is to add a counterpoint to the themes elicited by the noble Earl, Lord Howe, and other noble Lords who have spoken in the debate.

The news about the determination by NICE on the combination therapy of Interferon alpha and Ribavirin has been most welcome. However, that must not obscure the fact that there is still a range of issues, that we have discussed today, along with steps to be taken which are of crucial importance to HCV patients and, indeed, to those who may be diagnosed in the future, which are almost as important as the actual treatment given to patients.

Even in respect of yesterday's decision, consultants such as Dr Graham Foster of St. Mary's Hospital and Dr William Rosenberg of Southampton University Hospital have gone on record to say that they are worried that health authorities may not prioritise funding to meet the NICE recommendations. I hope that, during the course of his speech, the Minister will be able to give assurances about the timing of funding becoming available for this treatment.

As we have heard, the incidence of hepatitis C appears to be much higher than previously thought. It is now estimated to affect some 0.7 per cent of the population, or between 200,000 and 600,000 people in the UK. This compares with 1.8 per cent in the US and, indeed, some 170 million people worldwide who are reckoned to be infected.

Those deriving hepatitis C from blood transfusions and infected blood products number some 7,000 in total. As we have heard, the key route nowadays for the majority of hepatitis C sufferers, is from injecting drug use. However, it also occurs from other causes

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such as tattooing and body piercing. Eighty-five per cent of those infected develop chronic disease. We have been told that some 30 per cent will die of it.

The time-lag is long, some 20 to 25 years from the initial infection to when the symptoms appear. This means that it is people in their forties who are showing the symptoms of their infection which probably derived from drug use in their twenties.

A report in the journal, Gut, in July of this year, described research carried out between 1997 and 1999 among 4,825 women in the St. Mary's Hospital ante-natal clinic. It showed that one in 100 women were infected with hepatitis C. This implies that we have a slightly harder figure than the range of 200,000 to 600,000. It implies that 400,000 people in the UK may be infected. We have heard from the noble Lord, Lord Turnberg, the importance of ante-natal screening.

What needs to be done? As the noble Earl, Lord Howe, and campaigners have made clear, a national strategy--as exists in many other European countries and Australia, and as is being formulated in the USA--is required, together with its counterparts in local trusts and health authorities. A recent survey by the British Liver Trust showed that only 20 per cent of hospital trusts appear to have a strategy for hepatitis C. Only 6.7 per cent of the trusts surveyed thought that HCV was a high social and health priority.

Setting a national strategy means establishing the prevalence of HCV, an issue to which many noble Lords have alluded; it means monitoring the epidemic--because that is indeed what it is; it means establishing the most effective ways of preventing further infection; it means ensuring proper diagnosis; it means ensuring appropriate treatment; and it means ensuring appropriate social support and care.

More research is needed. I believe that the department has allocated only about £500,000 for research into HCV and injecting drug use. If we are faced with an epidemic of this proportion, does not the Minister agree that we need far more resource devoted to research?

In terms of prevention--which is vital because 40 per cent of all liver cancer is caused by hepatitis C--as the noble Lord, Lord Turnberg, and the noble Earl, Lord Howe, said, there must be the institution of confidential counselling, as there is with HIV testing and as is recommended by NICE. It is vital that we identify sufferers. The French plan to identify 85 per cent of sufferers within the next two years. We appear to have no such plan, according to an Answer to a Parliamentary Question in July this year. Why not?

As to treatment, it is vital that hepatitis C sufferers receive the appropriate treatment, not only because there are effective treatments but because the ultimate end result of hepatitis C--liver disease and cancer--will be far more expensive to care for in terms of treatment and transplants. As some noble Lords have mentioned, the cost could be as high as £9 billion. There is a great shortage of donor organs in any event, as your Lordships will be aware.

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To ensure the appropriate treatment there must be treatment protocols, perhaps in the form of national guidance or perhaps a national service framework. If NICE had the resources--which it currently clearly does not--this would be an appropriate task for it. The clinical guidance has been promised for three years, yet we appear to be no closer to it than we were.

But, above all, the appropriate resources must be made available by the health authorities and trusts. It has been noticeable how influential the NICE appraisal of taxanes has been and how health authorities have responded with an appropriate allocation of resources to pay for treatment for breast and ovarian cancer. I hope that they will do likewise after the current NICE guidance and that budgets of between £7,000 and £12,000 for a course of treatment of combination therapy can be found for appropriate patients. I hope that the Minister will give those much needed assurances about the funding which must follow if NICE's guidance is to mean anything. Will the Minister grasp the nettle? I look forward to his response.

8.13 p.m.

Lord Hunt of Kings Heath: My Lords, I am grateful to the noble Earl, Lord Howe, for initiating the debate and I appreciate the contributions made by noble Lords. It has been a wholly constructive debate.

Let me say at once to the noble Earl, in particular, and to other noble Lords that I fully accept the argument that effective healthcare services are needed now for patients with hepatitis C, or HCV as it is commonly known. I also fully accept that if it is not actively tackled HCV may become a significant health problem in the future. I agree with the noble Earl that there is much to be done.

The stark facts, as the noble Earl suggested, are that HCV is the biggest cause of chronic liver disease. Some 250,000 people may be infected in this country. Both the noble Earl, Lord Howe, and the noble Lord, Lord Clement-Jones, posed questions about the estimated prevalence and incidence of hepatitis C in the UK. My understanding from the current information available to the department is that the prevalence of chronic carriage of hepatitis C may be around 0.5 per cent of the general population--that is, about 300,000 people in the UK and 250,000 people in England.

The incidence of hepatitis C is not known as the virus is usually acquired without symptom. There is also likely to be an increase in the diagnosis of hepatitis C in the next 10 years as individuals who have carried the virus for some time are identified through the wider testing of groups which have been at risk.

I know that data published in the medical journal, Gut, on 18th July reported a hepatitis C prevalence of 0.8 per cent in the population of pregnant women in inner London. However, the advice I have received is that estimates of such infections based on inner cities, where there may be clusters of people at higher risk due to injecting drug use, may not be representative of the country as a whole. My understanding is that surveys of pregnant women have reported a prevalence as low

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as 0.2 per cent in other parts of the country. This leads to the general conclusion that the prevalence in the country as a whole may be around 0.5 per cent.

As the noble Earl said, for most patients the virus manifests itself as a chronic illness with life-long implications. All too often patients with HCV are the most vulnerable members of society. In addition to counselling and support services, there are currently only two drug therapies licensed for treatment. Of course, with little chance of a vaccine being developed to prevent infection, HCV prevalence is likely to increase.

On the issue of vaccination, to which both the noble Baroness, Lady Masham, and the noble Lord, Lord Colwyn, referred, my understanding is that there is currently no vaccine to protect against hepatitis infection. Sadly, it seems unlikely that there will be one in the near future. As the noble Lord suggested, as the virus is known to mutate at a particularly rapid rate, this makes the development of an effective vaccine extremely difficult. A number of centres around the world are involved in research into a vaccine. We must hope that eventually there will be a successful outcome. But we certainly cannot plan our future services on that basis.

People who became infected years ago without realising it are now presenting with liver disease. HCV infects the blood. Injecting drug users, health workers and those who received blood transfusions before screening was introduced are potentially at risk. Once transmitted, the virus may quickly cause inflammation of the liver, an acute illness from which people recover. But, as has been suggested, for perhaps 80 per cent of those people the infection becomes chronic and has longer term health implications.

People with chronic HCV infection can remain virtually symptomless for many years, but during this time the liver becomes inflamed and damaged. If not treated, again as has been suggested, it may eventually progress to severe liver disease or occasionally liver cancer, causing the liver to fail and the patient to require a transplant.

Of course we need to talk about treatment and care, but prevention is crucial. I agree with my noble friend Lord Turnberg on that. In relation to blood, the risk of transmission of hepatitis C via blood donations has been virtually eliminated by the screening of blood donors for antibodies to the hepatitis C virus and the treatment of blood products. I hope that answers the point raised by the noble Baroness, Lady Masham.

Again as my noble friend suggested, needle exchange schemes can play a very important role in hepatitis C prevention. We are working to improve availability through shared care schemes and by liaising closely with health authorities. We have issued guidance to the NHS on the purchasing of services for and the clinical management of injecting drug misusers, which includes advice about hepatitis C. I want to assure noble Lords that further work is planned to strengthen the current activity by reminding health authorities of the importance of measures to tackle hepatitis C.

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Prevention is vital; so are treatment and cure. I listened with great interest to the remarks in relation to counselling and testing. I fully acknowledge that the support provided by counsellors is invaluable. They may come from a wide variety of backgrounds: some may be specialists in drug misuse; others may have a background in other diseases such as haemophilia, which has close ties with HCV.

Picking up on the NICE recommendations in relation to counselling and advice services, where NICE recommended that they be reviewed I can assure noble Lords that we shall indeed do that. I accept the challenge to introduce a co-ordinated approach. The same goes for issues relating to testing. We accept the need to review our current policies and arrangements on testing--again, as recommended by NICE. I hope that that will lead to a more co-ordinated response in the future.

So far as concerns treatment with drugs, it is by no means the perfect solution. Interferon monotherapy and combination therapy, where Ribavirin is added, have unpleasant side effects and may not be suitable for all patients. It was clear to the Government that the NHS needed guidance to ensure that patients gained maximum benefit from the available treatments. That was why NICE was asked to investigate the use of combination therapy as a matter of urgency. That guidance was published yesterday.

Briefly, combination therapy is recommended as the treatment of first choice for moderate to severe HCV in the following categories: previously untreated patients and those patients treated with Interferon monotherapy who responded but then relapsed. There are many other recommendations in the NICE guidance and I commend those guidelines to noble Lords. But I accept the key question that has been raised in relation to funding.

The experience so far, as the noble Lord, Lord Clement-Jones, suggested, is that NICE guidelines will be followed by health authorities. That is the whole purpose of NICE: to ensure a uniform response throughout the National Health Service. I am not convinced about a central funding mechanism; I have severe doubts about its practicality. I also believe that it would run the risk of absolving health authorities from making local decisions and from responsibilities that they ought to be carrying.

The additional resources that we have put into the health service this year are intended among other things to enable NHS bodies to fund positive recommendations from NICE. NHS bodies will fund treatment on clinical recommendations in line with the guidance from NICE. I believe that sufficient resources have been allocated for the current tax year to allow that to happen.

So far as concerns clinical guidance, a number of questions were asked about its availability. Professional guidance on the management of patients with HCV will also be available shortly. The Royal College of Physicians, the British Society of Gastroenterology and the Association for the Study of

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the Liver are finalising evidence-based clinical guidelines for the treatment of HCV. I hope that those guidelines, alongside the implementation of the NICE guidelines in relation to drugs, will produce a consistent approach throughout the National Health Service.

Before replying to a number of points raised in the debate, I should like to commend the remarks of my noble friend Lord Turnberg in relation to the work of the Public Health Laboratory Service. This service provides invaluable public health data, crucial in supporting health authorities in the formulation of local healthcare strategies. I assure noble Lords that we are looking at how we can enhance that information and how we might develop a modelling tool to predict future trends.

Eighty per cent of HCV transmission is associated with injecting drug misuse. Misconceptions, rumours and misinformation are some of the greatest allies of HCV transmission. We are keen to avoid the stigmatisation that the first HIV infected people had to deal with and we recognise the value of accurate information. To tackle these issues I am pleased to announce that this year we shall be funding a number of activities to increase the skills of professions working in the drug treatment field so that they can be better equipped to encourage drug misusers to stop injecting and sharing. Work will begin almost immediately on the development of up-to-date guidance on hepatitis C and strategies to minimise transmission, to be backed up by regionally based workshops and seminars.

The noble Earl, Lord Howe, and the noble Lord, Lord Clement-Jones, asked about research. Recent Department of Health funded research indicates that the prevalence of HCV among drug misusers is falling. That is good news, and many people deserve credit for it. But government funding does not stop there. We have, for example, commissioned a £1 million study into the potential health benefits of treating the disease in its mild stage. Because of the harsh treatment regime, the current advice is to avoid drug therapy at this stage as the potential risks are likely to outweigh any known benefits. But there is much in that area that we need to research. I should be happy to place in the Library a copy of the extensive research projects that are under way.

I was asked about preventing hepatitis C transmission in prisons. The Prison Service has a strategy for preventing the spread of communicable diseases in prisons which covers training, education, prevention, risk reduction and harm minimisation. This is complemented by the Prison Service's drug strategy. Disinfecting tablets for the purpose of clearing drug taking equipment have been trialled in 11 establishments since 1998. We are now considering whether we should extend the trial to all establishments.

The noble Lord, Lord Colwyn, is absolutely right as regards the position of dentists. Provided that dentists comply with the accepted standards of infection control in their surgeries, dental treatment for patients

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with hepatitis C poses no additional risk to the patient, the dentist, the dental staff or other patients. I fully accept the point raised by the noble Lord about oral health. I thank him for his remarks on the dental strategy.

In conclusion, I say to the noble Earl, Lord Howe, that I accept the challenge that he posed to the Government. I believe that the direction we are taking will maximise NHS services for people with HCV. I believe that we are taking a strategic approach. With regard to prevention and control activities, we are considering how we can strengthen and develop prevention and surveillance. We will continue to raise awareness of HCV by working with the voluntary sector and others to provide information and advice for the general public and for those groups most at risk. We are funding activities to increase the skills of professionals working in the drug treatment field.

With regard to treatment and care, we have recognised the increasing importance of hepatology, not only for patients with HCV but for those with other complex liver diseases who should have access to specialist hepatology units with the necessary knowledge and expertise. We have discussed this with leading liver organisations, including the British Liver Trust and the British Association for the Study of the Liver. We have agreed that the BASL should apply formally for recognition as a sub-speciality of gastroenterology for training purposes. We believe that that will supply a future good number of fully trained hepatologists who will then be able to care for these patients.

We are developing a commissioning framework to ensure that specialist hepatology services are developing to uniform standards throughout the country. I should tell the noble Earl, Lord Howe, that regional specialist commissioning groups will be heavily involved in implementing the commissioning framework. I believe that that will lead to a much more uniform and co-ordinated approach throughout the country. Alongside the recommendations of NICE in relation to the use of combination therapy, I believe that that will ensure that, in the future, the NHS will have the ability to prevent this distressing disease, as far as that is possible, and ensure that counselling and testing services are up to the required standard. We must be able to provide the best treatment.

I believe that the noble Earl, Lord Howe, has performed a great service for the House by raising such important issues tonight. I hope that noble Lords are assured that we are very taken with the seriousness of the points raised. We are determined to do what we can to ensure that the services and the prevention of this most distressing disease are given as much priority as is possible.


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