§ Motion made, and Question proposed, That this House do now adjourn.—[Mr. Jamieson.]
§ 10.4 pm
§ Ms Roseanna Cunningham (Perth)I should say at the outset that I am aware that circumstances have changed since I applied for this debate last week. With the latitude of the House, and of necessity, the debate will have to range a little beyond what was originally intended.
I am also aware that the Under-Secretary of State for Scotland, the hon. Member for Strathkelvin and Bearsden (Mr. Galbraith) is medically qualified. I must concern myself with the fact that I shall spend the next 10 minutes or so talking about matters about which I rather suspect he knows infinitely more—at least in a medical sense—than I. With the agreement of the Under-Secretary, three other hon. Members hope to intervene briefly because they have particular constituency interests. I shall try to keep my remarks to a minimum in order to allow time for those speeches.
Haemophilia is a genetically inherited condition where the blood does not clot due to lack of clotting factor. It is treated by intravenous infusions of clotting agents. Hon. Members may be aware of factor VIII—that fraction of blood which enables blood clotting and forms an essential part of treatment to enable people with haemophilia to live as normal a life as possible.
Clotting factor proteins have traditionally been produced by pooling plasma from between 20,000 and 60,000 blood donations and separating the required factor. However, if any of the donations are infected with a blood-borne virus or prion, the entire pool could be affected and the virus passed on to the people receiving treatment. That has occurred in the not too distant past.
Approximately 1,200 people with haemophilia were infected with the human immunodeficiency virus—HIV—through NHS treatment, and, to date, approximately 700 people have died. In addition, 4,800 people with haemophilia were infected with the hepatitis C virus—HCV—through their NHS treatment. Those infections are believed to have taken place before 1986, when procedures were introduced to kill the viruses.
The HIV epidemic brought into sharp focus the vulnerability of the blood supply to infectious agents. That vulnerability was not only highlighted by HIV transmission through blood transfusion: it greatly accentuated the need for safer plasma derivatives. The HIV epidemic also witnessed the identification of the hepatitis C virus as a major agent responsible for non-A non-B hepatitis—a virus which has infected a very high percentage of people with haemophilia, and is associated with significant mortality and morbidity.
Those dangers prompted the use of a genetically engineered recombinant alternative to human plasma-derived factor VIII. Until now, certainly in Scotland, such treatment has been restricted to certain groups of patients such as children, previously untreated patients and those not already infected by serious blood-borne virus infections. I say "until now", but, in fact, as of Friday or Saturday, Tayside health board is providing synthetic factor VIII to adults.
The United Kingdom haemophilia centre directors' guidelines on treating haemophilia state that recombinant factor VIII is the treatment of choice for all patients with 1170 haemophilia A. Furthermore, concerns about the continued use of human plasma-derived products intensified due to the potential transmission of new-variant Creutzfeldt-Jakob disease through pooled, plasma-derived blood products.
That has been of great concern to patients still receiving human-derived factor VIII, many of whom have already endured similar periods of anxiety in the 1980s, when HIV and viral hepatitis emerged as major health threats for haemophilia patients being treated with human factor concentrates. In short, the arrival of CJD as a threat removed any justification there may have been for denying recombinant factor VIII to any person with haemophilia.
I sought the debate following an approach from a constituent of mine who, with constituents of my hon. Friend the Member for North Tayside (Mr. Swinney) and the hon. Member for Dundee, East (Mr. McAllion), took the courageous stand of refusing treatment unless and until the synthetic form of factor VIII was made available. That action speaks volumes for the strength of feeling among people with haemophilia.
On Friday, the Department of Health and the Scottish Office announced that certain blood products, including factor VIII, were to be banned, and I know that Tayside health board has now instructed consultants to make arrangements to offer recombinant factor VIII to all patients in Tayside, with immediate effect. I welcome that development, but my regret is that it was so long in coming that my constituent and others were forced to contemplate such drastic, life-threatening action.
As a small footnote, I add the fact that today I heard from a representative of the West of Scotland Haemophiliacs Society, who was informed of a mother in the Western Isles whose 11-year-old son was today refused recombinant factor VIII at Yorkhill hospital, which is within the remit of the Greater Glasgow health board. I therefore suspect that the position is not yet totally resolved throughout Scotland.
The Government's announcement does not end concerns about the availability of recombinant factor VIII. There remain many questions that need to be answered and many issues that need to be addressed. The press statement issued by the Scottish Office on Friday said that the Scottish National Blood Transfusion Service should be allowed to import plasma from non-United Kingdom sources to manufacture blood products.
Over the past few years, people with haemophilia have been forced to endure an inordinate amount of worry and suffering. Many, understandably, do not see why they should continue to risk their health by taking human plasma-derived factor VIII—wherever in the world that plasma has come from—when there is a risk-free synthetically produced alternative available.
The substantial cost of providing recombinant factor VIII therapy will inevitably result in a reduction in other services and initiatives for my constituents unless central funding for recombinant factor VIII is made available to assist health boards. Plasma-derived factor VIII concentrate production in Scotland is currently centrally resourced. If those products are now to be phased out, there must be scope for additional funding for the purchase of recombinant products.
1171 It is undeniable that recombinant factor VIII is more expensive to produce than that produced from human plasma, but I feel that that financial cost must be weighed in the balance against the real concerns of people with haemophilia.
The abolition or reduction of VAT on the product, or some other way around the problem with recombinant factor VIII, which is classified as a drug rather than a blood product, would be a major step towards easing the financial burden on health boards and on the Scottish Office. Today's papers carried reports that scientists at the Roslin institute have been successful in producing factor IX with low production costs—an indication, perhaps, that cheaper sources of synthetic factor VIII may not be far away.
Scotland has an enviable tradition of an integrated national approach to haemophilia care, with the aim of ensuring that all Scottish patients receive the same standard of care irrespective of where they live or which hospital they attend. Without Scottish Office support for continuing a consistent national approach, it is possible that recombinant factor VIII concentrate therapy for haemophilia may be funded by some health boards and not by others.
Patients and practitioners throughout the United Kingdom undoubtedly welcomed the announcement on Friday afternoon, but now they deserve speedy answers to three questions. How soon will recombinant factor VIII be made available to all with haemophilia? What funding mechanisms will be put in place so that health boards are not adversely affected? Is there any way in which recombinant factor VIII can be exempted from VAT, or VAT can be reduced, to lower the total cost?
§ Mr. John Swinney (North Tayside)I congratulate my hon. Friend the Member for Perth (Ms Cunningham) on securing this debate, and thank her for the opportunity to make some brief remarks.
I was contacted over the past few weeks by John McAughey, a constituent from the village of Stanley in Perthshire. I would like to read an extract from a letter he sent to the haemophilia centre director at Dundee's Ninewells hospital:
I am writing to inform you of my decision to refuse treatment of my Factor VIII deficiency with Liberate Factor VIII concentrate, or any other plasma derived product. I have deliberated long and hard before reaching this decision but I feel I have no other choice. I am no longer prepared to take risks with my life and I am tired of playing Russian roulette every time I treat a bleeding episode because the purity of derived products cannot be guaranteed.That illustrates the deep anxiety of many individuals about the safety of the products they are using to treat a serious medical condition. I saw Mr. McAughey and his wife yesterday, and they were relieved to receive the news from the Dundee NHS trust that the recombinant factor VIII treatment was to be made available and funded by the trust.That is welcome news, but they left with me a strong sense that their concern was not just for themselves, but for others suffering from haemophilia in other parts of Scotland and the United Kingdom who may not receive or have access to the same treatment under the current regulations and arrangements. Tonight is a welcome 1172 opportunity for the Minister to place some of the Government's views on the matter on the record, to clear up the anxiety that is clearly felt by some of our constituents, and clarify where the Government believe policy is going.
§ Mr. John McAllion (Dundee, East)I congratulate the hon. Member for Perth (Ms Cunningham) on securing this debate, and I thank her for allowing me the opportunity to make a brief intervention.
I confirm her account of events. My constituent was also one of those refusing treatment because he had been denied access to recombinant factor VIII. He contacted me about 10 days ago, and I immediately contacted Tayside health board. I was promised a written brief to update me on the situation. That had not arrived by the time I left for Westminster on Monday, but I was relieved—as was my constituent—that the money was found to make available the synthetic factor VIII for the treatment, as he had requested.
It is clear that, until Friday, that treatment was not available to adults in particular areas of Scotland—while in other areas it was available. There was an inconsistency in policy across Scotland in this respect.
It is also clear that Tayside health board was not making the treatment available to adults on the ground of cost. If we have a national health service—as the Government always claim—everyone living under that national health service should have equal access to treatment. That is something which the Government must clarify, and I hope that the Minister takes this opportunity to put at rest the minds of our constituents and to set out clearly the Government's policies.
§ Mr. Anthony Steen (Totnes)I thank the hon. Member for Perth (Ms Cunningham) for allowing me to intervene. My constituency is 650 miles south of Perth, but I have a similar problem with a constituent. I am grateful to her for allowing me one minute to raise the issue.
I congratulate the Minister and the Government on insisting that treatment be made available to all children under 16. I regret that I did not know that until this morning, because the press release was the first news we had. It would have been nice if that could have been announced in the House, rather than through the newspapers. Children under 16 will now be entitled to recombinant factor VIII—something for which I have campaigned for a long time. I have constituents with a seven-year-old child, Michael Ashley, who suffers from haemophilia. His parents will be delighted, as I am, by the announcement.
Could the Minister inform the House of the time scale that the South and West Devon health authority will be adopting in providing my constituent with recombinant factor VIII? Will he also confirm that extra funds will be made available for this treatment, so that other treatments are not prejudiced?
In his press release, the Secretary of State for Health said:
I have decided that all health authorities must make arrangements to ensure that the synthetic version of Factor VIII, known as recombinant, is made available to those children under the age of 16 who are not already receiving it, and to new patients.1173 I am much encouraged by that, and I hope that the Minister can reassure me that, although I am 650 miles south of Perth, the advantages that are available to people in Scotland will be also be available to people in Devon. Once again, I thank the hon. Member for Perth for her generosity in giving me this opportunity to speak.
§ The Parliamentary Under-Secretary of State for Scotland (Mr. Sam Galbraith)I, too, thank the hon. Member for Perth (Ms Cunningham) for bringing this important issue to the attention of the House. I recognise that it is not only a matter of great concern to the haemophiliac community in Tayside but part of a wider concern throughout Scotland.
We want to ensure that the safest possible treatment can be given to this vulnerable group of patients. I thought that the hon. Lady gave a splendid dissertation on the causes of haemophilia and its treatment—I give her nine out of 10 for it. I also thank my hon. Friend the Member for Dundee, East (Mr. McAllion) and the hon. Members for North Tayside (Mr. Swinney) and for Totnes (Mr. Steen) for their contributions.
Ministers in this and the previous Administrations have considered this matter extensively since recombinant factor VIII became available as a licensed product in 1993. Of course, I appreciate that interest in the provision of this drug—a product which is not derived from human plasma—has been heightened since last week's expert advice to the Government about the theoretical possibility of transmission of new variant Creutzfeldt-Jakob disease via blood products. I should add that nothing was banned other than the use of albumen as a stabiliser in products. We are awaiting the advice of the Committee on Safety of Medicines on individual products.
Scotland has a good story to tell on the provision of recombinant factor VIII, but, before I come to that, I want—in case any doubts were raised by last week's announcement about blood products and new variant CJD—to reaffirm the Government's commitment to Scotland's blood transfusion service and the excellent job it does in supplying Scotland with safe, high-quality blood and blood products.
The Scottish National Blood Transfusion Service has served Scotland for more than 50 years and continues to be at the forefront of excellence in health care delivery and new technology in its efforts to deliver a first-class service to Scotland's patients. I know that the blood transfusion service is fully committed not only to developing its service but to ensuring that it continues to enjoy the excellent record it has earned for the safety and high quality of its blood and blood products.
The service's record in this area is world class. A review has shown that, over the past five years in Scotland, no infection of HIV or hepatitis B or C has been detected as a result of a patient being transfused with blood or receiving a blood product. That is a truly impressive record, given that 1.25 million blood donations were collected, processed, tested and delivered to hospitals during that period.
Until recently, the factor VIII blood-clotting factor could be obtained only as a plasma-derived blood product and for many years has been one of the blood transfusion 1174 service's staple products, manufactured at its blood products plant, the protein fractionation centre. As the hon. Lady said, factor VIII is a concentrated blood product, which is made from the pooled donations of many thousands of donors. The heightened risk of one infected donor spreading disease in such a way is, as she said, obvious.
Again, I congratulate the blood transfusion service on the wonderful work that its staff have done over the years to refine and improve the safety of its plasma-derived factor VIII product—a fact which is too easily overshadowed by the terrible tragedy of infections such as hepatitis B and C and AIDS. The record of the current product that the service produces speaks for itself. There have been no reports of HIV infection since 1984, and no reports of hepatitis B or C since the current product was introduced in 1992. In considering these matters, we should not lose sight of that outstanding record.
Despite that excellent record, there is no denying that, with the recent appearance of recombinant factor VIII as a commercially produced drug, we have a product which may reassure many haemophiliacs and which many haemophilia clinicians have identified as their preferred treatment. I also know that the current theoretical risk of new variant CJD transmission in blood products has fuelled their wish to switch to the recombinant product as swiftly as possible.
Scotland has not been deaf to those concerns. In 1996, the Government recognised that provision needed to be made for the national health service in Scotland to begin the transition to purchasing recombinant factor VIII for its haemophilia A patients. In response to requests from the haemophiliac community and its clinicians, funding of £1.1 million was provided to all health boards in Scotland, including Tayside, to enable them to begin the process and to provide the recombinant product for the most vulnerable groups in the haemophiliac community, such as children. That has been happening for some years.
Having helped to kick-start the process, the Government have asked health boards to pursue the matter as part of their pursuance of health care strategies throughout Scotland. All funds for the treatment, as for others, have been devolved, and I know that the boards have been considering long and hard the priority that it should be given against the other competing demands on their budgets.
That is what the boards are there to do, and it is not for me to take decisions for them, but I want to tell them that they should do what is right by patients, for the enhancement of patient care. I am glad to say that, in my experience so far, they have had that overriding need in the forefront of their minds.
The Government were very encouraged last year when the health boards decided to establish a national consortium to advance the process on an integrated, equitable and fair basis throughout the country, with the consortium co-ordinating the provision of factor VIII in Scotland and helping boards to keep in step in their approach to the issue. My hon. Friend the Member for Dundee, East and the hon. Member for Perth mentioned that, as well.
1175 The consortium includes a number of health boards and representatives of the haemophilia directors—the clinicians who oversee haemophilia treatment in Scotland. Its key role is to advise on the priority that health boards should give to allocating from their funds provision for recombinant factor VIII and, in so doing, achieving an expansion of recombinant provision that maintains an equality of treatment for all patients. That point was raised by all the hon. Members who spoke in this debate.
The consortium has also recognised the concerns raised among haemophiliacs and their clinicians about new variant CJD, as illustrated by the cases presented by hon. Members tonight. I can confirm that it recently recommended to all health boards in Scotland that, in the light of those concerns, the extension of recombinant treatment in Scotland should be accelerated so that all health boards should offer recombinant factor VIII treatment to all their haemophilia A patients within the next year.
Health boards are still considering the matter, but both the consortium and the boards are clear about the importance of the key point: that the process must be pursued on an integrated national basis designed to ensure equity of health care throughout the country for Scottish patients, irrespective of where they live or which hospital they attend.
I can confirm that Tayside health board has already responded to the consortium's recommendations, and has agreed to offer the recombinant product immediately to all its haemophilia A patients still on plasma-derived factor VIII, including, of course, the constituents mentioned by hon. Members tonight.
1176 I hope that that allays hon. Members' concerns, and serves to demonstrate the energetic steps that the NHS in Scotland has taken and continues to take in its efforts to ensure that haemophiliacs in Scotland are given equal access to available treatment.
The hon. Member for Totnes asked about provision in England; that does not fall within my portfolio as a Scottish Office Minister, but I assure him that the matter will be responded to by the Department of Health, and someone will write to him.
The hon. Member for Perth asked me some additional questions, which I hope I have answered in part, about how soon the new treatment would be universally available. All but one of the health boards have agreed to provide it, and we expect the final one to provide it soon; so the answer is, virtually right away.
The hon. Lady asked about central funding. Moneys for such treatments are held by health boards and not central Government. As I said, it is the boards' duty to balance the needs within their areas and to fund those matters appropriately. That goes on all the year round, as new treatments become available, and health boards have been able to do that. She mentioned that money might be saved because the product has not been produced centrally. The costs are all fixed centrally, and the dropping of one plasma product would in no way affect the cost of the provision of the services, so there are limited savings to be made there.
Finally, the hon. Lady asked me a question about value added tax. As she will appreciate, that is not a matter which is within my portfolio, but I will certainly look into it and someone will write to her. I hope that, in answering those questions, I have dealt with all the issues raised.
§ Question put and agreed to.
§ Adjourned accordingly at half-past Ten o'clock.