Hansard

I am grateful for the opportunity to inform the Parliament of the circumstances surrounding a blood transfusion incident involving variant Creutzfeldt-Jakob disease and of the action that is now being taken.

The background is that, in March 1996, a blood donor, who was at the time free of the signs of variant CJD, donated blood to the National Blood Service in England and Wales. Shortly after that, the donated blood was transfused into a patient who underwent surgery for a serious illness. Three years later, in 1999, the donor developed variant CJD and died from it. The recipient of the blood died in the autumn of 2003.

Initial post-mortem examination of the recipient of the blood showed changes in the brain indicative of CJD. Further examinations and tests confirmed the diagnosis of variant CJD. The link between the donor and the recipient was first reported to officials in the Department of Health in England on 9 December 2003, at which time the diagnosis of variant CJD in the recipient was still being confirmed.

I was first alerted to the incident on Friday 12 December. In the light of the statement delivered yesterday in the House of Commons by the Secretary of State for Health, I thought it right that the Scottish Parliament should be similarly informed and made aware of the action that has been taken in Scotland and in the rest of the United Kingdom.

In the light of the facts that I have outlined, it is possible that the disease was transmitted from donor to recipient by blood transfusion. I wish to emphasise, however, that that is a possibility and not a proven causal connection. It is also possible that both individuals separately acquired variant CJD by eating BSE-infected meat or meat products. This is a single incident and it is thus impossible to be sure what the route of infection was. However, I am advised that the possibility of transmission being transfusion related cannot be discounted, albeit that this is the first report from anywhere in the world of the possibility of transmission of variant CJD from person to person via blood.

As yet, there is no blood test for variant CJD. There is therefore no way of screening blood donations for the presence of the CJD group of diseases. In recognition of that, since 1997, a range of precautionary measures—based on expert advice—has been put in place. It might be useful if I briefly rehearse them. In 1997 a research study, the transfusion medicine epidemiology review, was funded to examine links between all variant CJD cases and any form of blood transfusion. It is through that study that the association between the two patients was identified. Since 1997, all cases of variant CJD that are reported to the national CJD surveillance unit and which are diagnosed as having "probable" variant CJD result in a search of blood donor records. If the patient has given blood, any stocks of that blood are immediately destroyed.

On 17 July 1998, a £70 million programme was introduced to remove most of the white cells from blood that is destined for transfusion. That process of leucodepletion was progressively implemented by the Scottish National Blood Transfusion Service and completed by the end of August 1999. On 12 November 1998, a further £30 million programme was announced to phase out the use of UK-sourced plasma in the manufacture of blood products. From the end of September 1999, all blood products in Scotland have been made using plasma that is sourced from the United States of America and Germany. On 17 December 2002, to ensure continuity of supply, the Department of Health purchased the largest remaining independent US plasma collector, Life Resources Incorporated.

As indicated yesterday by the Secretary of State for Health, the National Blood Service informed the Department of Health that 15 people in England and Wales had received donations of blood from donors who subsequently developed variant CJD. In Scotland, two similar cases are known to us. Of those individuals, we have been informed that some received blood after leucodepletion had been implemented and others before that happened. The earliest such transfusion was in 1993 and the latest in 2001. All will be told about the circumstances of their case and will be given the opportunity to discuss the risks with an expert counsellor. The Scottish centre for infection and environmental health, supported by the Health Protection Agency, is in the process of contacting the affected patients in Scotland.

Of course, other patients, including haemophiliacs, will have received plasma products before plasma was sourced from the USA and Germany. They will have received products that, because they are derived from the large pools of plasma that are donated from many thousands of people, are heavily diluted. The UK-wide CJD incidents panel considers the risks for this group to be even lower than it is for those who received whole blood.

It is very difficult to trace all individual recipients of products that were made from those plasma pools, but the incidents panel will be advising on a case-by-case basis which recipients will need to be contacted as the necessary information becomes available. Those people will also have the opportunity for a discussion with an expert on an individual basis.

These are very significant arrangements that are designed to counter the possibility of transmission from blood. The need for continuing vigilance remains, however, and the relevant expert groups have been considering whether further measures are required in relation to variant CJD and blood.

In October 2003, our expert advisory committee on the microbiological safety of blood and tissues for transplantation advised, on the basis of a risk assessment, that further action, such as stopping people who have received a blood transfusion giving blood, was not necessary. However, in the light of the present case, the committee was asked to look comprehensively at whether further precautionary measures could be taken that would not adversely impact on the safety or availability of blood. Meanwhile, in Scotland, we have asked the Scottish National Blood Transfusion Service to begin to assess the implications of deferring the taking of blood from those who have received transfusions.

In conjunction with the other health departments, we are also initiating action to consider whether the use of blood and blood products can be confined to situations in which, medically, that is absolutely needed. Although that has been an on-going activity for some time, it will now be given added impetus. We have been concerned to ensure that people who may be worried about the implications of this incident are given appropriate advice. The NHS helpline has therefore been briefed with relevant information and the chief medical officer has written to health professionals updating them on the present situation. We will take any further appropriate steps to inform and reassure people who remain concerned.

Finally, I emphasise that this tragic case must be seen against a background in which, since 1996, some 24 million units of blood or blood components have been given to patients in the United Kingdom. Blood transfusion can be a life-saving treatment but no medical treatment is free of all risks. A wide range of measures is routinely used to reduce the risk of transfusion by screening for HIV/AIDS, hepatitis B and C and other infections. Indeed, we are generally regarded internationally as having a very safe blood service, especially because of our precautionary approach. That said, we will continue to strive for yet further improvement.