On The Establishment Of My Country's Drug Patent Period Compensation System

The examination and approval of drugs on the market leads to the reduction of effective patent period,which leads to the lack of incentives for drug research and development in the patent system,and makes the compensation system for drug patent period come into being.Already in some developed countries or regions to establish this system in our country,but also exists the problem,it is to establish the system in recent years is put forward and has not yet been implemented in practice.Some developed countries or regions has already established this system,but in China,where the problem also exists,the establishment of the system has only been put forward in recent years,and has not yet been implemented in practice.Therefore,it is necessary for us to study and discuss on the establishment of the system in our country.In discussing the establishment of the system,this paper first defines the concepts related to the system,analyses the impact of the establishment of the system on drug accessibility and the right to public health,and then draws the conclusion that the system is not fundamentally opposed to the accessibility of drugs and the right to public health,but when applied,it is necessary to define the right boundary of the system,and always adhere to the principle of giving priority to the right of public health.Subsequently,this paper analyzes the basic value of the system to ensure that its basic value can be fblly embodied and brought into play in the concrete construction of the system.Whether a system should be established or not,in addition to examining the basic value of the system,we need to study the necessity of establishing the system.The main reason for the need to establish a compensation system for the patent period of drugs lies in the fact that drug research and development is difficult,risky,time-consuming,high-cost and easy to be imitated.In addition,different countries have strict control over the listing of drugs,which results in short effective patent period and no return on investment.Therefore,the system needs compensating for the loss of the effective patent period,recovering return on investment,and encouraging innovative R&D activities of original research and development enterprises,and then promotes the output of original research and development and the progress of drug R&D technology.Starting from the patent incentive theory,the establishment of the system allows not only to have the difference of patent duration but also to have legitimacy.The above contents are analyzed from the theoretical level,but the establishment of a system should also be examined from the practical level.Therefore,this paper then investigates the United States,Japan and the European Union which have established the system,and analyses the system in international treaties and its impact on developing countries.Finally,it comes to the conclusion that although the system has greatly promoted the development of the pharmaceutical industry in developed countries such as the United States,Japan and the European Union,it has developed the system by accepting international treaties.For China,the system has not played its due value and function,even to a certain extent,it is not conducive to the development of domestic pharmaceutical industry in developing countries and the protection of the right to public health.From these differences,we can also see that the establishment of a system must be combined with local conditions in order to achieve good results,and the developed countries should not blindly implement the system to the developing countries,but should always adhere to the principle of human rights priority and the principle of balanced interests.After sorting out the above problems,how to establish the system in China has become the focus of this paper.This paper holds that the construction of the system must adhere to certain guiding principles,such as the principle of national conditions,the principle of the right to health,the principle of encouraging industrial development and the principle of coordinating legal system.In building the system according to these basic principles,this paper first reviews the legislative trend of the system,and then interprets the recently promulgated "Patent Law(Draft Amendment)".It is believed that although the voice for the establishment of the system is increasing and the draft also proposes the establishment of the system,the draft does not elaborate more on the specific construction of the system.By using comparative law for reference,this paper designs the competent authorities,compensation scope,application conditions,calculation of time limit and the procedure of objection of the system,and puts forward concrete plans on how to ensure the connection and cooperation of the system with patent link system and medical insurance catalogue system in practice,so as to achieve the best practical effect of the system.