仿制药品政策应当成为中国药物政策体系不可或缺的组成部分

Generic drug policies should be indispensable part of China's Pharmaceutical policy system

创新药品给予患者可获得机会,仿制药品给予患者可支付能力;创新药品是仿制药品的前提,仿制药品是创新药品的基础,二者是医药市场上不可或缺的组成部分。"以仿为主"的我国医药产业,由于历史客观原因导致仿制药品低水平重复申报/生产、低价恶性竞争等弊病遗害目前依然存在,医药产业整体创新程度低、产能过剩是我国必须直面解决的突出问题,亟需建立完善的国家仿制药品政策体系。近期,国家推行的仿制药品质量一致性评价实际上是对历史遗留问题的一次订正补课行为,同时,相关政策也已经为仿制药品政策体系搭建指明方向。近期需要重点配套实施几个具体落地政策措施,包括在带量采购试点及医疗保险支付、医院使用中对优质仿制药品给予支持,鼓励专利挑战及建立首仿药品独占期保护等制度,尽快建立仿制药品质量综合评价标准体系等,以激励仿制药品企业积极提高生产水平和工艺创新能力,推动我国仿制药品产业发展,实现"制药强国"战略目标。

Patients acquire available opportunities from innovative drugs, and affordability from generic drugs; Both innovative and generic drugs are indispensable parts of pharmaceutical market, the former is the precondition while the latter is the basic. Although pharmaceutical industry in China mainly relies on generic drugs, there are even various drawbacks persisting in that field. Due to the objective historical causes, repeated application and low level production and cut-throat competition at low price remain in generic drugs field. The insufficient innovation and excess capacity of the whole pharmaceutical industry are the prominent problems that we must solve, therefore, a sophisticated policy system for generic drugs should be built immediately. The consistency evaluation on the quality and efficacy of generic drugs which carried out recently, is an amendment for those historical drawbacks. At the same time, relative policies have set the direction for generic drug policy system building. We need to focus on the implementation of several policies and measures, including supporting high quality generic drugs in pilot procurement with volume, medical insurance payouts and hospital uses, encouraging patent challenge and building the protection period of market exclusive rights for the first imitation that challenges patent success, setting up the Comprehensive quality evaluation standard system for generic drugs as soon as possible and so on. Aimed at encouraging generic drugs companies to actively improve production levels and technological innovation, promoting the development of generic drugs industry and achieving the strategic goal of "Becoming a Pharmaceutical Power".