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7.12 pm
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.
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.
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 8 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.
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. Syms: I 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. Denham: My 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
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.
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.
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.
- Adjourned accordingly at twenty-nine minutes past Seven o'clock.
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