对中国仿制药品政策的思考  

Revisited on China's Generic Drug Policy

作　　者：胡善联[1] HU Shan-lian

机构地区：[1]复旦大学公共卫生学院,上海200032

出　　处：《中国药物经济学》2018年第11期6-10,共5页China Journal of Pharmaceutical Economics

摘　　要：中国是仿制药品的大国,但不是仿制药品的强国,我国药品市场60%～80%为仿制药品。首先是质量问题,其次仿制药品的政策问题是造成我国仿制药品质量参差不齐的根本原因。2016年全国仿制药品使用估计在2182亿元人民币。本文系统分析了质量一致性评价、基本药物和批量采购三大政策对我国仿制药品生产的影响。尽管,通过世界卫生组织(WHO)的药物等效性及生物等效性试验,但临床治疗的等效性还有待观察,2018年底要完成的289种仿制药品的一致性评价,仍然是一项长期的艰巨任务。随着基本药物目录的扩容,前瞻性开展质量一致性评价是十分必要的。本文还分析了基本药物政策和药品批量采购政策对仿制药品发展的契机和问题。作者强调了仿制药品的价值,并提出低价竞争带来的负面效应,以及面临带量采购的挑战。最后,对未来仿制药品的政策提出了几点建议。中国应加强优质原料药的生产,从提高仿制药品的质量出发,最后走向自主创新药品的转型发展道路。中国的药品市场要适应基本医疗的需要,应发展以仿制药品为主,原研药品和创新药品并存的均衡市场,为人民提供更加优质的药物,提高人民健康水平。China is a large country for using generic drugs,but it is not a powerful one on the production of generics, although the share of generic drug market is around 60% and 80% in the value and volume,respectively,in China. The key issues are the quality as well as the policy impact on generic drugs,which are the root cause of the uneven quality of generic drugs in China.In 2016,the expenditure of generic drugs was estimated at 218.2 billion RMB. The paper systematically analyzes the impact of quality consistency examination,essential medicine and bulk procurement policies on generic drug production in China.Although the pharmaceutical equivalence and bioequivalence tests have been carried out yet,the equivalence of therapeutical equivalence treatment remains to be observed.The consistency evaluation of the 289 generic drugs has to be completed by the end of 2018;it is still a long-term and arduous task.With the expansion of the future list of essential medicines,it is necessary to carry out the quality assessment in a prospective way.The article also analyzes the opportunities and challenges under the development of generic drugs.The author emphasizes the value of generic drugs and points out the negative effects of low-price competition,and the recent challenges of purchasing in quantity.Finally,some policy suggestions are put forward.China should strengthen the production of high-quality APIs,proceed from improving the quality of generic drugs,and finally move towards the way of transformation and development of domestic innovative drugs.In order to meet the needs of basic medical care,China's drug market should be focused on generic drugs and balance the coexistence of originals and innovative drugs,so as to provide more high-quality drugs for the people and improve their health status.

关 键 词：仿制药品 质量一致性检验 基本药物 药品政策 

分 类 号：R951[医药卫生—药学]