On The Perfection Of Compulsory Licensing System Of Drug Patents In China

Since the outbreak of novel coronavirus pneumonia,public health and safety have been seriously threatened.Various countries have introduced corresponding countermeasures to protect their lives and health.Drug patent compulsory licensing system is favored by countries all over the world because it can effectively alleviate the public health crisis and improve the accessibility of drugs,so it has also attracted widespread attention in the academic circles.The number of studies on the compulsory licensing system of drug patents in China has also increased significantly.This paper believes that the implementation of compulsory licensing of drug patents is of natural necessity in China.Combined with the research results of existing scholars,starting with the external environment of China’s compulsory licensing system of drug patents,this paper shifts the focus to the factors such as policies and national conditions outside the system,Put forward suggestions to improve the system in line with China’s current environment,give full play to the legal value of the system,and ensure the life,health and safety of our citizens.Firstly,by combing the current legislative situation of China’s drug patent compulsory licensing system,and in two incomplete practice cases,this paper finds several existing problems in China’s drug patent compulsory licensing system: first,the system norms are vague and chaotic,the norms of drug compulsory licensing are not systematic,and the same legal provisions are stipulated in different legal documents,Separating the complete implementation conditions from the practices in different legal documents will inevitably cause trouble to its application;Second,at present,the regulations on the use fee of the compulsory licensing system of drug patents in China are not clear enough,and there is no definite calculation standard;Third,the compulsory licensing system of drug patents in China is lack of supervision system;Fourth,the implementation of China’s drug patent compulsory licensing system is lack of unified department implementation;Fifth,the procedure of China’s drug patent compulsory licensing system is lengthy and rigid.Drug patent compulsory licensing is mostly used for emergency public health emergencies.However,China only has the general provisions of drug patent compulsory licensing,but there is no emergency start-up procedure.Then this paper analyzes the existing problems of China’s drug patent compulsory licensing system.The main reasons for the slow development of the system are: first,the conflict between private rights and public rights.Secondly,the environment of China’s drug patent compulsory licensing system is cramped and embarrassed.Since many public health and safety incidents have occurred in China,the implementation of the drug patent compulsory licensing system has been avoided by other means.The main reason is that China’s own generic drug manufacturing level is low and subject to the pressure of the international trade environment.In order to balance the conflict between private rights and public interests,meet the needs of public health and drug accessibility,ensure the good development of local pharmaceutical industry and increase the chips of national interest competition,China urgently needs to improve the drug patent compulsory licensing system.Therefore,it is suggested that we should first learn from the experience of the international drug patent compulsory licensing system,and then improve it from three aspects: determining the legal norms of the system,optimizing the allocation of system procedures and improving the implementation environment of the system: in terms of legal norms of the system,we need to standardize its legal system and clarify the compensation expenses;In terms of optimal allocation of procedures,after the occurrence of emergency health and public security events,through the special procedures for compulsory license of drug patents,optimize the application process,and build a complete generic drug manufacturing approval system under the unified regulation of public power,so as to promote the improvement of the compulsory license system of drug patents.