药品责任中发展风险的控制及多元救济制度的构建
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篇名: 药品责任中发展风险的控制及多元救济制度的构建
TITLE:
摘要: 目的:论证药品责任中发展风险的控制路径及多元救济制度,为相关制度的完善提供参考。方法:通过论证药品发展风险抗辩的正当性,分析药品生产者研发创新与患者权利保障的平衡关系。结果与结论:相关药品责任立法应当通过规范药品发展风险的适用标准、明确药品责任后续义务的履行、注重药品生产过程中的设计环节和完善药品国家行业标准来控制发展风险;同时要构建以专项基金救助为主、责任保险为辅的救济模式来救助因发展风险致害的用药者。现阶段应围绕资金来源、适用条件、补偿范围、救济程序等方面重点构建药品发展风险基金制度,完善发展风险救济。
ABSTRACT: OBJECTIVE: To expound and prove development risk control pathway and diversified remedy mechanism in drug liability, and to provide reference the improvement of related system. METHODS: Through expounding and proving the legitimacy of defense in drug development risk, the balanced relationship between drug producers’ R&D and innovation and sufferers’ rights protection were analyzed. RESULTS & CONCLUSIONS: The drug development risk should be controlled by drug liability legislation through specifying the standards of drug development risk, clearing the obligation of post-sale duties, emphasizing the drug design step in the manufacturing process, refining the national industry standards. It relies mainly on the special relief fund system, while drug liability compulsory insurance system subsidiary to minimize the loss of patients suffered from drug development risk. The drug development risk fund system should be constructed in fields of fund sources, application condition, compensation range, remedy program, etc. to improve development risk remedies.
期刊: 2016年第27卷第34期
作者: 叶涛
AUTHORS: YE Tao
关键字: 药品责任;发展风险;风险控制;多元救济
KEYWORDS: Drug liability; Development risk; Risk control; Diversified remedies
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