摘要
目的为完善我国药品责任法律制度提供参考。方法介绍和分析德国《药品法》中药品损害责任的主要内容和特色,借鉴德国的立法经验和优势。结果与结论我国应尽快针对药品损害责任进行特别立法,明确药品缺陷的认定标准、否定发展风险抗辩、建立因果关系推定原则、设定赔偿的最高限额,建立符合我国国情的药害救济制度。
Objective To provide a reference for improving the legal system of liability for damages caused by medicines in China.Methods The main content and features of liability for damages caused by medicinal products in German Medicines Act were introduced and analyzed,and the experience and advantages of the German legislation were used for reference.Results and Conclusion China should legislate on liability for damages caused by medicines as soon as possible,clarify the standard of drug defects,deny the defense of development risk,establish the presumption principle for causal relationship,set the maximum amount of compensation and construct the relief system on medicine damage based on China′s situations.
出处
《中国药事》
CAS
2012年第11期1206-1209,共4页
Chinese Pharmaceutical Affairs
关键词
德国药品法
药品损害责任
药害救济制度
赔偿机制
German Medicines Act
liability for damages caused by medicines
relief system on medicine damage
compensation mechanism
