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Precautionary measures announced for blood products
26/02/1998
Precautionary measures to ensure the continuing safety and high quality of Scottish blood products have been announced today by Sam Galbraith MP, Minister for Health at The Scottish Office, following expert advice received from the Committee on Safety of Medicines (CSM).
The announcement followed consideration by the CSM of the hypothetical risk that nvCJD may be transmitted via blood products, and taking into account the conclusions this week of the CSM's European counterpart - the Committee on Proprietary Medicinal Products (CPMP).
CSM have decided to look carefully at individual blood products - such as clotting agents - to assess how the NHS can best meet individual patient's needs. In light of this assessment, it will advise which products should remain UK-sourced and which should be sourced from non-UK sources.
Mr Galbraith said:
"These measures have not been taken because UK - or Scottish - blood products are unsafe. Nor is there any new scientific evidence to show that nvCJD can be transmitted via blood or blood products. The risk remains a hypothetical one.
"However, the Government fully accepts the advice of the CSM, and I have therefore decided that the Protein Fractionation Centre (PFC), part of the Scottish National Blood Transfusion Service (SNBTS), should be allowed to import plasma from non-UK sources to manufacture blood products where deemed advisable by the CSM. Even with a hypothetical risk, it makes sense to use safe, alternative sources if they are available."
In Scotland, the Government already funds the use of the synthetic version of the Factor VIII blood clotting agent for the treatment of child haemophiliacs and new haemophiliacs. This removed any hypothetical possibility of nvCJD transmission for this vulnerable group of patients. A Health Board consortium is also presently considering the extension of such treatment for all haemophiliacs across Scotland.
Sir David Carter, Chief Medical Officer, added:
"The use of imported plasma is purely a precautionary and temporary measure until we know more about whether nvCJD can be transmitted.
"The blood products which will be considered by the CSM include the clotting agent Factor VIII, immunoglobulins which are used in the treatment of a range of diseases such as tetanus, and albumin which is used in the treatment of burns and serious accidents and as a stabiliser in some vaccines. In each case it will be important to weigh up the hypothetical risk from nvCJD against the risk to patients if they do not get the products they need."
The Chief Medical Officers in Scotland, England, Wales, and Northern Ireland jointly support the CSM's precautionary approach:
"Whole blood, used in blood transfusions, is not affected by today's measures. The Government has made it clear that it will take all practical steps recommended by the relevant expert committee (SEAC) to maintain safety.
"In line with that commitment, the National Blood Authority have already been instructed to prepare a strategy for the possible removal of white blood cells from donations by the process of leucodepletion, should it be required.
"There is absolutely no question of any risk to blood donors of contracting nvCJD. We still need just as much blood for transfusion as before. Donated blood is vital to the work of the NHS and I urge all donors to continue their life-saving work."
BACKGROUND
1. Anyone concerned about the precautionary safety measures announced today can call the NHS Helpline in Scotland. The number is 0800-22 44 88.
2. Plasma is the fluid in which the blood cells (red cells, white cells, and platelets) are suspended. It is separated off when whole blood is centrifuged.
3. Blood products include Factors VIII and IX, used in the treatment of haemophilia, immunoglobulins used to treat immunodeficiency, and a range of less commonly used products. Blood products are made from pools of plasma derived from between 20,000 and 66,000 donations.
3. The CSM is the UK Committee on the Safety of Medicines, set up following the Medicines Act 1968. It advises Ministers on regulatory matters.
4. The CPMP is the European Committee on Proprietary Medicinal Products. It advises the European Commission on regulatory matters in a specific group of pharmaceuticals notably those derived from biotechnology and high technology.
5. The PFC is the Protein Fractionation Centre which is part of the Scottish National Blood Transfusion Service and which produces blood products from plasma for use in the NHS in Scotland.
6. Recombinant Factor VIII is a synthetic form of clotting agent used in the treatment of haemophilia.
7. There have been 23 confirmed cases of new variant CJD.
News Release: 0382/98
February 26, 1998