赵静

摘 要 目的：基于药品缺陷探索建立药品上市许可持有人（MAH）风险控制和转移机制，促进MAH制度在我国顺利实施。方法：首先分析药品全生命周期中的药品缺陷类型;继而分析在MAH制度下，在产业链开放式委托的环境下不同类型药品缺陷的来源和“过错方”;在此基础上，结合国外经验和我国实际情况，提出建立持有人风险控制和转移机制的建议。结果与结论：药品缺陷分为设计缺陷、生产经营储运质量缺陷和使用缺陷，其中设计缺陷和生产经营储运质量缺陷是最主要的缺陷。设计缺陷主要有人为因素造成的设计缺陷和当前科学技术水平不能发现的设计缺陷，“过错方”依照不同情形既可能是研发机构也可能是持有人;生产经营储运质量缺陷的过错方是药品生产、经营及储运企业。对于设计缺陷，建议通过保险+救济相结合的方式建立我国药品不良反应补偿机制;对于生产经营储运质量缺陷，建议以药品质量责任保险为主、合同约定为补充的方式，让“过错方”担负起应有责任。

关键词 药品上市许可持有人;风险控制;风险转移;药品缺陷

中图分类号 R951 文献标志码 A 文章编号 1001-0408（2021）03-0261-07

DOI 10.6039/j.issn.1001-0408.2021.03.02

ABSTRACT   OBJECTIVE： To explore the mechanism of risk control and transfer of drug marketing authorization holders （MAH） based on drug defects， and to promote the smooth implementation of MAH system in China. METHODS： Firstly， the types of drug defects in the whole drug life cycle were analyzed， and then the sources and “fault party” of different types of drug defects in the open commissioning environment of the industry chain under the MAH system were also analyzed. Based on it， the mechanism of risk control and transfer of MAH was established combined with foreign experience and Chinas actual situation. RESULTS & CONCLUSIONS： Drug defects were divided into design defects， manufacturing & operation & storage & transportation quality defects and use defects， among which design defects and manufacturing & operation & storage & transportation quality defects were the two most important defects. Design defects mainly included those caused by human factors and those could not be found by current level of science and technology，the “fault party” according to different circumstances may be both the research and development institutions and may be the MAH. The “fault party” of production & operation & storage & transportation quality defects was the drug production & operation & storage & transportation enterprises. For design defects， it was recommended to establish Chinas adverse drug reaction compensation mechanism through a combination of insurance and relief. For production & operation & storage & transportation quality defects， it was recommended that the drug quality liability insurance as the main， contractual agreement as the supplement， so that the “fault party” should assume due responsibility.

KEYWORDS   Marketing authorization holders; Risk control; Risk transfer; Drug defects

藥品上市许可持有人（Marketing authorization holders，MAH）制度是涉及药品产权根本变革的制度，其将药品的上市许可与生产许可“解绑”，允许科研单位等不具备生产条件和未取得药品生产许可证的机构，经申请药品上市许可成为MAH[1]。该制度的实施一方面可以激发科研机构创新的活力，另一方面委托生产的放开也有利于减少行业低水平重复建设、促进资源整合[2]。……