BSE--a risk for man through pharmaceutical products? Position and politics of the German pharmaceutical industry.

Since BSE is not a zoonosis and the occurrence is with some exceptions extremely low or absent, the risk to man through pharmaceuticals is remote. However, the agent of BSE is very resistant and the disease in cattle is always lethal, as are analogous diseases of man. Therefore, the German pharmaceutical industry, through a working group, actively contributes to reasonable measurements leading to a further reduction of any theoretical risk. This theoretical risk has to be evaluated by a balanced consideration of various risk and safety factors. Process validation should be reserved for occasional single cases, since it is still time-consuming and contradicts animal protection. Industry prefers further research into the characteristics and behaviour of the BSE agent. The "Note for Guidance..." recently established by the EC commission seems a reasonable approach for a harmonized attitude of both industry and authorities. The German pharmaceutical industry would appreciate a balanced consideration of both pharmaceutical and food industries, which would also re-establish the confidence of the public.