The patient, with severe haemophilia A, died aged 74 from an unrelated cause and did not present any clinical signs of vCJD or any neurological disorders whilst alive. 11 years ago, amongst various treatments for haemophilia, the patient received factor VIII products manufactured using plasma products taken from an English donor in 1996 who developed vCJD six months after their blood donation. British health authorities are currently investigating the probable risk factor or factors to explain the presence of this pathological protein found in the tissue sample of the patient at post mortem. This person was exposed to the British food risk and the transfusional risk (red cells, platelets) at the same time.

In France, the food risk exposure linked to Bovine Spongiform Encephalopathy (mad cow disease) is significantly lower to that in the United Kingdom and since 2000, the risk of transmission of Creutzfeldt–Jakob disease through blood products has been considered by experts at the French Health Products Safety Agency (Afssaps) as a matter of precaution. Under the aegis of the authorities, the appropriate measures have been put in place by the different health institutions involved in order to control the potential risks. The medical selection of donors has been tightened by the EFS (French Blood Agency) since 1997 with the exclusion of donors who have previously had a blood transfusion and 2001 saw the exclusion of donors who have spent a total of one year in the UK between 1980 and 1996. An additional measure has been in place since June 2002 concerning the systematic deleukocytation of plasma for fractionation.

On an epidemic level, it should be noted that Great Britain reported an exposure of the population to potentially BSE-contaminated food (Mad cow disease) 10 to 20 times higher than in France. Currently, there are 23 cases of patients having developed variant Creutzfeldt-Jakob disease in France, against 168 cases in Great Britain and 21 cases in the rest of the world. No new cases have been reported in France since the end of 2007 and only two cases in the United Kingdom where the epidemic has been on the decline since 2000. Please note the exception of Spain who has reported 3 new cases of vCJD in 2008.

Benefitting from the latest technological advances in the biological safety of its medicinal products is at the heart of the LFB’s public health mission and has been a priority since its creation in 1994. The manufacturing processes of all of LFB's medicinal products include several safety stages which are documented in the registration records. These biological safety stages to eliminate potentially present infectious agents have been evaluated step by step and as one unit, from beginning to end in experimental models recognised by the experts and authorities. Reduction factors of at least 1000 can be expected at each stage. In light of this, nanofiltration technology has been developed as an additional safety stage used mainly for coagulation factors (factors VIII, IX, XI, von Willebrand etc), antithrombin III and intravenous immunoglobulins.

This technology, used under laboratory conditions, filters out prion agents by a factor of 1000 to 100,000. Therefore this reduction factor is in addition to the laboratory safety stages already used in the manufacturing process of medicinal products. On the basis of this data, the latest assessment of transmission risks carried out by the AFSSaPS expert group, concluded that "The measures currently in place are deemed to be effective and proportionate so as to ensure the correct benefit-risk ratio for blood derivatives”.
The Afssaps expert group is going to meet in the coming weeks to assess the situation following this new information.

For 15 years, the quality of the LFB's plasma-derived medicinal products has contributed to the development of global healthcare with regards to safety and therapeutic effectiveness for hundreds of thousands of patients with serious and sometimes rare diseases.