Exploration Of My Country's First Generic Drug Market Exclusivity Period System

In order to reduce financial burden and control the expenditure of medicine,many countries have introduced policies to encourage the development and use of generic drugs.Generic drugs are a huge social public wealth recognized by the World Health Organization and play an important role in the health system of global public.As a substitute for the patent drug,generic drugs pour into the market after the expiration of the original patent,dividing the market share of the patent drug,and the initial R&D cost of generic drugs is low,and the price is usually much lower than patent drug.China is a big country of generic drugs,but not a powerful country of generic drugs.In the history of our country,there was a period of "lack of medicine ".Therefore,the government encouraged the production of drugs,but there were also a lot of repeated low-level imitations,which brought great threats to people’s access to medicines and life and health.In recent years,China is exploring the establishment of a coordinated development mechanism of generic drugs and innovative drugs to promote the upgrading of the pharmaceutical industry and solve the problem of "available,well-used,and affordable" for the people.The exclusive period system of generic drug market refers to the first application for generic drug listing to the drug approval department,and the patent challenge success to the patent drug,which can obtain a long period of market monopoly.In the exclusive period,there are exist the patent drug and the first imitation drug.The system has some important function,such as encouraging the challenge of drug patent and promoting the advance listing of generic drugs and reducing the price of drugs to balance the development of innovative drugs and generic drugs.Our country is exploring this system.However,in the practice of foreign countries and regions,the system has caused collusion between generic drug dealers and patentees,which signed a "reverse payment" agreement and delaying the entry of generic drugs into the market.At the same time,whether the exclusive right of the system can exclude the entry of authorized generic drugs is also controversial.Legal transplantation is a series of events.Based on the current medical policy environment,this paper makes a systematic and comprehensive study on the system of the exclusive period of the first imitation drug market,compares the establishment and implementation of the external system of the first imitation drug,combs the policy environment of the establishment of the system in China,and deeply explores the connection and coordination between the system and the existing system in the process of the localization of the exclusive period of the first imitation drug market,in order to provide further research.The first part of this study summarizes the basic situation of the exclusive system of the first drug market,and expounds the relevant concepts,the background and the system,the existing problems and influence of the market in China.The second part analyzes the reasons for the exclusive system of the first imitation drug market.The third part focuses on the specific content of the first generic drug market exclusive period system and the comparison of foreign systems,and discusses the impact of the system on the development of the industry and the emergence of monopolistic behaviors..Chapter Ⅳ puts forward the opinions and suggestions on the establishment of the exclusive period system of the first imitation drug market.