Blood and blood products from the UK are in general not on the German market

The latest press releases stated that the new variant of the Creutzfeldt Jakob Disease ((vCJK), which has emerged in the UK and is presumably caused by the pathogen of the mad cow disease, might be transmitted by blood. This information has caused a lot of concern that people in Germany might also be infected by blood and blood products from Great Britain. "But blood and blood products from the UK are generally not on the German market", said Professor Johannes Löwer, Head of the Paul-Ehrlich-Institut, which is the competent authority for blood and blood products in Germany. A marketing authorisation by written permission from the Paul-Ehrlich-Institut is required in order to bring blood products onto the German market, which are to be transfused directly to the patients, or products, which are industrially derived from blood plasma. In the marketing authorisation procedure, the institute examines and determines in writing the permitted origin of the blood collection centres and countries of the blood and plasma. "Blood and plasma collection centres from the UK have not and will not be accepted by the Paul-Ehrlich-Institut in the future" added Professor Löwer. The Paul-Ehrlich-Institut verifies these statements with the government release of every single batch of plasma products, and the regional authorities control them in inspections, which they regularly carry out together with the Paul-Ehrlich-Institut.

Since the first cases of vCJD occurred in 1996, 82 cases of vCJD (as of 4th September, 2000) of definitive or probable cases of vCJD have been observed. The Creutzfeldt Jakob Disease (CJD) affects the brain and normally leads to death within one year. The disease may be transmitted with material from the central nervous system to other recipients, but cannot be transmitted by pure contact with people suffering from CJD, in contrast to so many other diseases caused by viruses or bacteria. In particular, there is no epidemiologic evidence that the classic forms of CJD may be transmitted by blood or blood products. However, this statement cannot be made with respect to vCJD as the observation period is still too short. Rather the different nature of the pathogen distribution in the body is regarded as a piece of evidence that a transmission by blood and blood products might theoretically be possible. These considerations have been supported by the latest scientific publications about examinations with sheep, which have experimentally been infected by feeding them material from cows diseased with bovine spongiform encephalopathie (BSE, "mad cow disease"), from which the disease could be transmitted to other animals by blood.

As early as spring 1998, when the peculiarities of vCJD became known, the Paul-Ehrlich-Institut pushed through the regulation, on the basis of its authorisation of batch controls, that blood plasma from the UK would not be used any longer for the production of plasma products. In doing so, the institute acted in line with other European authorities, especially with the British one, which had banned the use of British plasma for the production of plasma products in their own country.

A cross-border trade for blood components for transfusion, such as concentrates from red blood corpuscles or platelets has in general never existed and does not exist. As mentioned above, this is officially stated in the appropriate marketing authorisation. However, it is not ruled out that in life-threatening emergencies a blood collection of a rare blood group may be imported, if it is not available at home.

The regulations described do rule out the most important conceivable source material for a possible vCJD transmission by blood and blood products. The question, which remains to be discussed, is whether the exclusion of blood collections from the UK should be extended by the exclusion of persons outside the UK, who were exposed to the risk of a vCJD infection. As vCJD is probably caused by the consumption of food containing material from BSE infected cows, which was possible in the years from 1980 to 1996, all persons who stayed in the UK during the offending period, and consumed food there, belong to this group. However, an exclusion of this group of persons in their entirety would be irresponsible, since it would result in shortages of blood and blood products in Germany. This effect can be alleviated if only those persons are excluded, who stayed in the UK only for a defined minimum period. Which limit can be set without endangering the supply of vital blood is currently the subject to an European-wide examination. But as it cannot be ruled out that an infection already occurs after a one day stay in Great Britain, (or France for that matter, where hitherto two definite vCJD cases have been described), any possible measure is incomplete, as long as blood and blood products cannot be completely dispensed with. Since this is impossible for medical reasons, the importance of a responsible use of blood and blood products must again be emphasised. The transfusion act of 1998, which requires the establishment of transfusion committees and transfusion representatives in every hospital, has laid the foundation for the reasonable use of blood and blood products.

The safety of blood and blood products has high priority for all persons involved in that matter. Therefore, new methods are introduced time and again, including the recent so-called leucocyte depletion, which removes undesired blood cells, which are also regarded as the carrier of the infectiousness of CJD and vCJD. In view of the numerous measures, which have been taken, as well as the extraordinarily rare occurrence of vCJD outside the UK (Germany, no case has as yet been observed), the medically necessary administration of blood and blood products should also be accepted by the patients affected.

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