我国首仿药促进型立法研究（上）

Research on Promoting Legislation of First Imitation Drugs in China(A)

我国首仿药的法制发展对于减轻患者的用药负担,整顿药品市场流通秩序,提高药品质量安全水平,促进仿制药产业持续健康发展具有重要意义。我国应当首先在法律上对首仿药予以明确定义,建立基于专利链接的首仿药数据保护制度,进一步设置告知期、起诉期、遏制期来完善程序性链接机制,通过加强国家药监局与国家知识产权局间的沟通协作,建立监管机构信息链接机制,以及完善药品数据保护制度。为保障首仿药的流通使用,我国需要从药品集中采购和医保支付标准两方面着手,同时应当加快出台首仿药价格优待政策的步伐。

The legal development of the first generic drugs in China is of great significance to alleviate the drug burden of patients,rectify the order of drug market circulation,improve the level of drug quality and safety,and promote the sustainable and healthy development of generic medicine industry.China should first make a clear definition of the first generic drug at the national level,establish a data protection system for the first generic drug,further set up a notification period,prosecution period and containment period to improve the procedural linking mechanism,and establish information links between regulatory bodies and improve the drug data protection system by strengthening communication and cooperation between the State Drug Administration and the State Intellectual Property Office.In order to ensure the circulation and use of the first generic drugs,China needs to start from two aspects:centralized drug procurement and payment standard of medical insurance,and at the same time,we should speed up the pace of introducing the preferential price policy for the first generic drugs.