§ Motion made, and Question proposed, That this House do now adjourn.—[Mr. Kevin Hughes.]
§ 7 pm
§ Mr. Robert Syms (Poole)I want to draw to the Government's attention a number of important points about NHS services for people with haemophilia, and I hope that the Minister will respond positively.
The current situation is pretty inequitable, particularly across different postcodes. Recombinant factor 8 is being provided to all haemophiliacs in Scotland and Wales, regardless of age and viral status, but in England it is restricted to children under 16 and a few people whose health authority has a policy of prescribing it. The Government took an important step in 1998 in making recombinant factor 8 available to all children; they now need to extend that to adults, as in Ireland and other European countries.
Another example of the inequality of the present arrangements can be found in the English haemophilia centres in Liverpool and Manchester, to which patients from north Wales go for treatment. The policy adopted by the NHS commissioners in Wales means that all haemophiliacs living in north Wales are entitled to receive recombinant factor 8, irrespective of age, postal code or viral status, and attend the Manchester or Liverpool centres. However, many people in Manchester and Liverpool and the surrounding areas do not have the same rights and benefits. That is substantially unfair. The restrictive policy in England might have been valid two years ago when supply problems and shortages would have prevented wider use of recombinant products, but those considerations no longer apply, and the Government should look at the matter afresh.
The provision of comprehensive care centres is also uneven and subject to postcode rationing. Some NHS regions have several comprehensive care centres for haemophiliacs, while others are under-provided. The south-west, where I come from, has none at all, and for haemophiliacs living in Cornwall or Devon, the nearest centre is in Basingstoke in Hampshire. The Trent region, however, has four centres. I hope that the Minister will tackle the need for more generous use of recombinant factor 8 for haemophiliacs.
I know that some haemophiliacs have inhibitors to factor 8, and other products, including recombinant DNA novo 7, are now safe and can be prescribed. The Government need to consider the issue of blood products.
More than 4,800 haemophiliacs in the UK are estimated to have been infected with the hepatitis C virus through the use of contaminated NHS blood products. More than 1,200 of those people were co-infected with HIV. Almost all those who received treatment before 1986—when viral inactivation procedures were introduced—have been affected. Every patient over the age of 14 may have contracted hepatitis C or HIV.
That has impacted greatly on the haemophiliac community. Hepatitis C attacks the liver and is potentially life threatening. Although the prognosis is unclear, up to 80 per cent. of those infected will develop chronic liver disease; up to 25 per cent. will have the risk of developing cirrhosis of the liver, and between 1 and 5 per cent. have the risk of developing liver cancer. It is estimated that the 542 progression to severe liver disease can take from 20 to 30 years, but some haemophiliacs may have been infected for over 25 years.
Figures from the UK haemophilia centre doctors organisation show that up to 1999, more than 113 haemophiliacs have died from liver disease and liver cancer, both of which are related to the end stage of hepatitis C infection. The actual number of deaths related to hepatitis C is likely to be much greater. The Government need to think carefully about that.
The previous Government set up a fund for those with HIV, and the Haemophilia Society and many others would like the Government to consider whether more money and similar administrative arrangements should be provided for those with hepatitis C. Families who have the infection are experiencing problems dealing with it, and they need help now.
There is no national strategy to deal with hepatitis C, nor any national guidelines on management and treatment of those affected. The total lack of planning for hepatitis C services throughout the UK means that standards of management and care after diagnosis vary widely: in some areas, patients have to wait months, or even years, to see a hepatologist or hepatitis C specialist, and there are 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, so the decision to start therapy is not easy, but at least there is a way forward. The Haemophilia Society is extremely concerned that health authorities have so far denied the new combination therapy to those who have haemophilia on the grounds of cost. Now that the National Institute for Clinical Excellence has recommended in favour of the use of the combination therapy, I hope that the Government will rapidly ensure that it is provided to patients with hepatitis C, where appropriate.
Many calls have been made for a public inquiry into how NHS blood products carried the infections. The Haemophilia Society has called for a public inquiry into the whole issue of blood products safety and infection by HIV and hepatitis C. No official inquiry or report has ever been carried out in respect of one of the greatest tragedies in the history of the NHS. The Scottish Executive is conducting an inquiry into events in Scotland, but the English Department of Health has so far refused to initiate such an inquiry. Internationally, the response has been very different: Canada has held a large-scale, four-year investigation and the Canadian red cross has set aside $70 million to $100 million to provide compensation to those infected with hepatitis C. In addition, the issue has been pressed, sometimes through court action, in France, Japan, Switzerland and other countries.
In 1987, the previous Government accepted the moral responsibility to compensate all those infected with HIV and established the Macfarlane trust in 1988 to fulfil that role. People with haemophilia were infected with hepatitis C in the same way and at the same time as those who were infected with HIV, and they experience many of the same problems as those infected with HIV. Therefore, on moral grounds, they should be offered similar financial help. The best way forward would be to extend the role 543 of the Macfarlane trust, as a vehicle to assist those with hepatitis C. Last week, the Government decided, rightly, that there would be a no-fault package of compensation for those with variant CJD, yet, thus far, more people may well have died as a result of hepatitis C infection through NHS blood products.
Given that the previous Government set up the Macfarlane trust and the current Government have accepted that help should be given to families in distress who have been affected by variant CJD, there is a strong argument for helping those unfortunates who have been infected by hepatitis C. After all, more than 100 might already have died as a result of the infection.
In a recent issue of The Lancet, more research evidence regarding the theoretical risk of transmission of variant CJD through blood was discussed. In the same week, representatives of the Haemophilia Society attended a special expert seminar held by EMEA—the European agency for the evaluation of medicinal products—on viral safety of plasma products with regard to non-enveloped viruses, particularly parvovirus B19 and hepatitis A. Taken together, the evidence from The Lancet report and from the EMEA seminar provide further justification for the Government's decision two years ago to ensure that all previously untreated under-16s with haemophilia should be treated with recombinant, as opposed to plasma-derived, products.
Although I am aware that there is, as yet, no evidence that either classical or variant CJD have ever been transmitted to people with haemophilia through blood products, new research shows that we cannot be certain that no risk of infection is associated with those products. Constituents of mine and others have told me that, although they were reassured in the past, their community has been badly affected, first, by HIV and, secondly, by hepatitis. They believe that if CJD rears its head, the haemophilia community is likely to be the first to feel the consequences. The significance of the findings, with the possible implication that blood donated by symptom-free vCJD-infected human beings might be infectious, is such that researchers chose to publish that finding immediately, without waiting for the completion of the study.
Considerable anxiety is generated in the community by fear of blood-borne viruses and diseases that might escape modern inactivation processes used in the manufacture of plasma products. The Haemophilia Society believes that it is most important that the Government take an early decision to ensure that recombinant blood products are given to everybody with haemophilia in England—not only to under-16s, but to adults as well.
There was criticism of the previous Government for the way in which they dealt with BSE. Certain products were banned for babies and children, but not for adults. We seem to have a similar situation in relation to the prescription of recombinant factor 8 and other recombinant products. As I have said, only children under 16 in England receive it. It is a matter of whether people are lucky to live in a particular area. That may depend on whether they receive the product. The Haemophilia Society wrote recently to the Department 544 of Health asking for a meeting to discuss its concerns. When the Department responds, I hope that it will make it clear that it would be happy to meet representatives of the society to discuss its concerns.
These are important issues. There are only a few haemophiliacs, but they have tremendous difficulties. They have suffered greatly because of their particular affliction through blood-borne products, which were provided by the national health service. They have to deal with these problems daily.
The Government should consider what they are doing. They should reflect on postcode rationing, especially as the standard of service in Wales and Scotland is now different from that in England. They should reflect on recombinant factor 8 and its provision to all those in need, including adults in England. There is the associated issue of comprehensive support for haemophiliacs. Many people think that haemophilia is external bleeding, but most of the worst damage is done by internal bleeding into joints. It is extremely important that physiotherapy or hydrotherapy is available quickly so that people's joints are not destroyed. A comprehensive means of service is vital to ensure that people's bodies can stand up to what happens.
The Government took a responsible view in 1998 when, because of CJD, they changed the way in which blood products were treated. That was done as a precaution. That was a good thing to do, but there is still great fear and much more research needs to be undertaken.
Even if the Minister cannot answer all the points that I have raised, I hope he will reflect carefully on what the Government can do to make life much easier for some unfortunate people. I look forward to hearing his reply.
§ The Minister of State, Department of Health (Mr. John Denham)I welcome you to your new position, Madam Deputy Speaker.
I congratulate the hon. Member for Poole (Mr. Syms) on securing the debate. He has raised an important set of issues. There are about 11,000 people with inherited bleeding disorders registered with haemophilia centres in the UK. These include haemophilia A, which affects about one in every 10,000 men, the rarer haemophilia B, which affects one in every 50,000, and the milder von Willebrand's disease, which affects about in 10,000 people, both men and women.
Haemophilia is a lifelong, painful and debilitating condition. However, modern treatment is very effective, with patients able to look forward to an excellent quality of life. Sadly, during the late 1970s and early 1980s, the majority of regularly treated patients with haemophilia were infected with either HIV or hepatitis C before it became possible to remove these viruses from clotting factors made from human plasma.
As a result, about 4,000 to 5,000 haemophiliacs are estimated to be infected with hepatitis C, and about 500 are still living with HIV. Most of those with HIV are also infected with hepatitis C, and this co-infection may accelerate the clinical course of both disorders as well as making the haemophilia more difficult to manage. They therefore face considerable medical and psychological problems over and above those faced ordinarily by people with haemophilia.
545 It is essential that the national health service is properly geared up to delivering the full range of clinical and support services needed by people with haemophilia and with treatment-acquired infections. These must include routine and emergency medical treatments, drug therapies, physiotherapy, counselling, genetic services and specialised services for HIV and hepatitis.
The treatment and care of haemophilia is provided by a network of comprehensive care centres and smaller haemophilia centres. Comprehensive care centres provide specialised care and support for patients and their families that is delivered by a multidisciplinary team. All haemophilia patients who need such support should have access to the facilities of a comprehensive care centre, although it may not be the facility nearest to them. I understand, for example, that many of the hon. Gentleman's constituents receive comprehensive care at St. Thomas' and Great Ormond Street hospitals and want to continue that arrangement.
The hon. Gentleman was right to say that there is no comprehensive care centre in the south-west region. I hope that, over time, that will be addressed by the regional specialised commissioning group, whose role is to identify specialist services at a regional level. However, I am assured that all people with haemophilia in the south-west have access to the services that they need. There are a number of haemophilia centres in the region and Bristol and Southampton, while not designated as comprehensive care centres, provide a good range of services for people with haemophilia.
Earlier this year, we published the NHS plan. Our aim is to improve health, tackle health inequalities and modernise the NHS and social care. We want people with haemophilia to benefit from those improvements in the same way as other patient groups. There is evidence that greater consistency in the delivery of clinical care for haemophilia patients is needed across the country. The professional groups with an interest in haemophilia have recommended the development of a set of minimum standards for service delivery. That should be an effective way to help to standardise all aspects of haemophilia services in the longer term and get rid of unacceptable variations in care.
The Haemophilia Alliance, which includes the Haemophilia Society and the UK haemophilia centre doctors organisation, is developing a national service specification. That specification will outline the key components of a high-quality haemophilia service—whether that is provided in the larger comprehensive care centres or the smaller haemophilia centres—and it will go out to consultation shortly. The intention is to publish the specification by the end of the year.
The Haemophilia Alliance has asked my Department to circulate through our national networks information about its work on the service specification, and that is what we are doing. We have also identified haemophilia services as appropriate for specialist service commissioning and three regional specialised commissioning groups—in London, the west midlands and the south-east—are reviewing their services at present. That process will help to put haemophilia services at the top of their agendas and support them in performance managing services for people with haemophilia.
The lives of people with haemophilia were transformed in the 1970s by the development of clotting factors, which brought the prospect of a much improved quality of life. 546 Tragically, an infection was associated with that development. Since the mid-1980s, the human plasma used to make clotting factors has been treated to remove HIV and hepatitis. With the onset of variant CJD, as an additional precaution, all human plasma-derived clotting factors used by the NHS are made from imported plasma. Therefore, everything has been done to ensure that the products needed and used by people with haemophilia are as safe as possible.
As medicinal products, all clotting factors have to be licensed by the Committee on Safety of Medicines under the Medicines Act 1968. They are therefore subject to periodic review and the same rigorous assessment for safety, quality and efficacy as all other medicines. Manufacturers of blood products, such as the NHS-owned Bio Products Laboratory, are also required to meet very stringent requirements of good manufacturing practice regulated by the Medicines Control Agency. In addition, the agency has in place the widely known yellow card system to pick up adverse effects of drugs, including the clotting factors. That adds to the monitoring of product safety.
As the hon. Gentleman said, over the past 10 years, new recombinant, or synthetic, clotting factors have been developed. The Haemophilia Society and others have petitioned us to make recombinant factor 8 and factor 9 the treatment of choice for people with haemophilia, largely on the ground that recombinant products are regarded as free from the risk of transmission of as yet unknown viruses and the theoretical risk of variant CJD.
Our position continues to be that the clinical case for recommending the use of recombinant clotting factors has not yet been made. Plasma-derived clotting factors have had an excellent safety record since the introduction of viral inactivation in the mid-1980s and there is no evidence that the recombinant product is more effective as a treatment.
None the less, two years ago the Government responded to the fears expressed by people with haemophilia—particularly families with haemophiliac children—about the theoretical risk of variant CJD. We required NHS trusts to provide recombinant factor 9 for all new haemophilia patients and children under 16 from April 1998, and factor 9 from April 1999, as soon as it became available. The policy was worked out with the Haemophilia Society and the UK haemophilia centre doctors organisation, and I hoped that it eased the anxieties of many parents about their children's future well-being.
Clinicians are, of course, free to prescribe recombinant products for all their patients if they choose, although I acknowledge that many health authorities have decided not to fund the treatment, on the basis of the clinical evidence of safety and effectiveness relative to cost. Even so, it is estimated that more than 50 per cent. of the clotting factors prescribed in the NHS in England are currently recombinant.
I also acknowledge that in Wales and Northern Ireland all haemophilia patients are offered recombinant products. The same will be true in Scotland by the end of March next year. I understand that the decision that led to that situation came from individual health boards, and was not made at national level.
547 In recognising that individual health authorities have taken different decisions, it is important to note the lack of evidence that there is anything to choose between recombinant and plasma-derived products in terms of safety and effectiveness. Of course, I understand why many people with haemophilia, because of their past experience of infection from blood products, are genuinely concerned about potential future risks from those products.
In September, we received fresh representations from the Haemophilia Society putting the case for universal provision of recombinant clotting factors in England. I can inform the hon. Gentleman that my noble Friend Lord Hunt will shortly be meeting the society and other members of the Haemophilia Alliance to discuss the issue.
§ Mr. SymsI thank the Minister for giving way. One or two people have moved from England to Wales because they believe that they will get the product prescribed in Wales. The society told me that it knows of at least two such cases. It is important to get matters right, and I am glad that the meeting has been arranged.
§ Mr. DenhamMy noble Friend leads on these matters and I await the outcome of those discussions. We have responded to the Haemophilia Society by recognising that we should hear it put its case.
I shall deal with some of the other issues that were raised. The first concerns a fund for haemophiliacs infected with hepatitis C. When we came to office, we met the Haemophilia Society and heard its arguments for a special payments scheme for people with haemophilia and hepatitis C, similar to the scheme for HIV. After long and careful consideration, we came to the conclusion that a special payments scheme should not be established.
Government policy remains that compensation or other financial help to patients is paid when the NHS or individuals working in it are at fault. The underlying principles are clear cut and independently established under common law. They apply to personal injury cases in general, not just those arising from health care. The same conclusion was reached by the previous Government, and the decision has been debated several times in both Houses. I am therefore unable to encourage the hon. Gentleman further on that issue this evening.
We must do what we can to enable people with haemophilia and hepatitis C to get on with their lives, and look constructively at how we can improve their health and well-being here and now. As the hon. Gentleman noted, until recently the only treatment available for hepatitis C was alpha interferon. That has a limited success rate—about 20 per cent.—in removing the virus and is not suitable for all patients.
The use of alpha interferon in combination with ribavirin appears to be significantly more effective, clearing the virus in about 40 per cent. of those treated.
Last year, we asked the National Institute for Clinical Excellence to assess urgently the interferon/ribavirin combination therapy. The guidance was published last week, and provides clear and authoritative advice for 548 clinicians and health care providers. In brief, combination therapy is recommended as the treatment of first choice for moderate to severe hepatitis C in previously untreated patients, and patients treated with interferon monotherapy, who have responded but relapsed. We accept NICE' s recommendations, and health authorities will be expected to implement its guidelines in the usual way.
NICE has also made two recommendations for implementation: viral genotyping facilities need to be upgraded, and counselling facilities need to be reviewed. We have noted and accepted the need to upgrade genotyping facilities and review counselling facilities. We will consider how best to carry out that work, and we will shortly formulate detailed plans.
For the longer term, several other therapeutic agents are in development, and they also show great promise. Treatment with pegylated interferon—a form of interferon that is modified to be slow release, more effective and possibly better tolerated—is likely to become available before too long. Other treatments, such as different combinations of drugs, are being researched. Significant developments and improvements in the treatments available are likely to occur in the next few years.
Before leaving hepatitis C, I shall deal briefly with the point that the hon. Member for Poole made about a public inquiry. He referred to an inquiry that was held in Scotland. The Scottish investigation was not a general inquiry into the history of hepatitis C and blood products. It specifically considered whether Scottish haemophilia patients were exposed to the risks of hepatitis C longer than they should have been, given the state of knowledge at the time and the fact that Scotland developed successful heat treatment later than England. I do not believe that there is a case on that basis for a similar investigation into circumstances in England.
Having considered the report, Scottish Ministers concluded that there was no evidence that the relevant authorities did other than their best for patients and that, consequently, the NHS should not pay compensation for non-negligent harm to the small number of haemophiliacs in Scotland who contracted hepatitis C during the period covered by the report.
The events of the 1970s and the 1980s are a complex story. However, all the information is in the public domain, and I do not believe that anyone's interest would be served by a public inquiry.
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 the Liver are now finalising evidence-based clinical guidelines for the treatment of HCV.
We are also developing a commissioning framework to ensure that specialist hepatology services are developed to uniform standards throughout the country. The regional specialist commissioning groups will be heavily involved in implementing the commissioning framework. An important element of that strategic approach is well-organised referral arrangements from primary care and centres that manage patients with that chronic viral infection, including people with haemophilia.
549 There is more that we can achieve by supporting and collaborating with the Haemophilia Society and professional bodies such as the UK haemophilia doctors organisation. Ministers have met both organisations this year to discuss services for people with haemophilia.
We provide an annual grant for the administration of the Haemophilia Society. We also provide some financial support to help with the excellent projects that it develops to support people with haemophilia.
550 The hon. Gentleman has raised many important issues. I hope that I have shown him our determination to make progress on several of them and assured him that discussions will take place on others. Doubtless I have had to disappoint him on one or two matters, but the debate has been useful.
§ Question put and agreed to.
§ Adjourned accordingly at twenty-nine minutes past Seven o'clock.