Further Measures for the Risk Prevention of Blood Collections

For reasons of risk prevention, persons who stayed in the UK (Great Britain and North Ireland) for more than six month between 1980 and 1996, should also be excluded from blood or plasma collections in Germany for the time being. The "Blood" Working Group at the Robert Koch Institut decided to make this statement during its session on 13th November 2000. "This recommendation is a precautionary measure, as the transmission risk of the new variant of the Creutzfeldt Jakob Disease (vCJD) by blood cannot completely be ruled out", said the chairman of the committee and Deputy Director of the Robert Koch Institut, Professor Reinhard Burger. However, a transmission of the pathogen prions by blood has hitherto not been observed in humans.

Furthermore, the "Blood" Working Group appealed to the blood collection services, which do not yet carry out the depletion of leucocytes which will become compulsory on 1st October 2001, to apply the depletion as soon as possible and not to postpone for reasons of higher cost. By means of the leucocyte depletion, the white blood corpuscles are removed from the donor blood. This procedure, which had originally been discussed in connection with leucocyte associated side effects, also serves the purpose of reducing the risk of a prion transmission.

The basis of the recommendations are new, if preliminary, scientific findings about possible ways of transmission of the BSE pathogen and the significantly rising number of cases of the new variant of the Creutzfeldt Jakob Disease (vCJD) in the United Kingdom. vCJD was probably caused by the consumption of food containing material of BSE-infected cows, above all between 1980 and 1996.

Older studies in various animal models already revealed that small quantities of the pathogen may occur in the blood. As the recent preliminary findings published in the specialist medical journal "Lancet" seem to show, this quantity may be enough to infect a recipient of a blood transfusion, at least in the chosen animal model: in these trials, brain tissue of a BSE infected cow was fed to sheep, from which full-blood had been taken which was given to healthy recipient sheep by intravenous drip. One out of 19 animals has so far become diseased with BSE-like symptoms.

In view of the potential health hazard, the "Blood" Working Group has taken the provisional data from the UK seriously, since the transmission of the BSE pathogen during the symptom-free incubation time without a species barrier (between sheep, by blood transfusion) and by natural routes of transmission (feeding of brain) seems to be possible for the first time. The transmission of the BSE pathogen by blood would bear the risk that the pathogen might spread also by blood or plasma products in the population (in contrast, the classic form of the Creutzfeldt Jakob Disease reveals no evidence of a transmission by blood or blood products).

"No vCJD case has hitherto been reported in Germany", said Professor Reinhard Kurth, Director of the Robert Koch Institut, about which such a notification would be necessary. "Blood and blood products from the UK are in general not on the German market", emphasised Professor Löwer, Head of the Paul-Ehrlich-Institut, which is the competent Federal Agency for the granting of marketing authorisations for blood components and blood products.

The exclusion of persons from blood collections, who spent more than six month in the United Kingdom, is expected to lead to only a slight decrease in blood collections (approximately 0.2 per cent). The "Blood" Working Group considers that this decrease is tenable in spite of the fact that blood transfusions and blood products are indispensable.

The "Blood" Working Group is an experts committee pursuant to section 24 of the transfusion act, which acts in advisory capacity for the Federal Government concerning the production and use of blood and blood products. Its offices are established at the Robert Koch Institut. The "Blood" Working Group consists of representatives of the National Medical Council, of the German Red Cross, of the association of doctors of federal and local blood transfusion services, of the Federal Ministry of Defence, of specialist medical societies, of the pharmaceutical industry, of the supervisory regional authorities and of associations of haemophilia patients, who are dependent on the regular use blood products. Furthermore the responsible Federal Ministry of Health, the Agency for Drugs and Medicinal Products and the Paul-Ehrlich-Institut are represented as permanent guests in the "Blood" Working Group.

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