缺陷药品惩罚性赔偿责任中“明知”要件的研究

Study on the "Knowing" Elements in Punitive Compensation Liability for Defect Drugs

明知药品存在缺陷仍然生产、销售,造成他人死亡或者健康严重损害的,应当承担惩罚性赔偿责任。本文借鉴刑法学中客观的超越要素理论,对缺陷药品侵权中的"明知"的法律渊源、认定标准和表现形式进行了研究;认为故意隐瞒药品缺陷、应当召回而未召回缺陷药品、故意违反药品质量管理规范、药品广告欺诈等属于明知的行为,造成他人死亡或者健康严重损害的,应当承担惩罚性赔偿责任。

Those who know well that the drugs have defects but still produce, sell, cause death or severe harm to people＇s health shall be liable for punitive compensation liability. In this paper, after studying the source of law, standard of acknowledgment and form of expression of ＂knowing＂ in defect drug infringement by using ob- jective beyond elements theory in science of criminal law as reference, the author declares that knowing behaviors include the behaviors of deliberately hiding drug defects; not recalling the defect drugs which should be recalled; intentionally violating the drug quality control standards; drug advertising fraud, etc., and if these drugs cause death or severe harm to other people, the punitive compensation liability should be charged.