Danner K
Dev Biol Stand. 1993;80:199-205.
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.
由于牛海绵状脑病并非人畜共患病，而且除某些例外情况外，其发病率极低或不存在，因此通过药品对人类造成的风险微乎其微。然而，牛海绵状脑病病原体具有很强的抵抗力，牛感染该疾病后总是致命的，人类的类似疾病也是如此。因此，德国制药行业通过一个工作组，积极推动采取合理措施，以进一步降低任何理论上的风险。必须通过全面考虑各种风险和安全因素来评估这种理论风险。工艺验证应仅用于偶尔的个别情况，因为它仍然耗时且与动物保护相悖。制药行业更倾向于进一步研究牛海绵状脑病病原体的特性和行为。欧盟委员会最近制定的《指导说明》……似乎是促使制药行业和当局采取统一态度的合理方法。德国制药行业希望对制药行业和食品行业进行平衡考量，这也将重新树立公众的信心。
