Research On The Compulsory Licensing System Of Pharmaceutical Patent

In the face of sudden and widespread outbreaks of major infectious diseases such as pneumonia virus,swine flu virus,monkeypox and so on,the public health situation is becoming increasingly serious.How to use the existing compulsory licensing system in order to solve the problem of access to specific medicines,so that we can face the urgent public health needs,It is necessary to analyze and study the implementation of compulsory license system of medicine patent.The research on compulsory license system of drug patent is consistent with the internal logic of patent legislation,which is the embodiment of human rights.Whether it is theory or system,the basis has full legitimacy.Compulsory licensing of drug patent in Europe,America,Asia,Africa and Latin America countries are relatively mature and common application.According to our legal system,compulsory licensing of pharmaceutical patents must be used to meet public health needs,including the control of infectious and non-communicable diseases,of which accessibility of medicines is an important issue.In this paper,based on the analysis of the development history of Chinese laws and regulations of compulsory licensing,starting with the existing system design,by simplifying the process and relaxing the restrictions,and respecting the basic national conditions and realistic conditions of our country,we actively study and draw lessons from the successful experience of other countries,and establish the compulsory drug patent licensing system scientifically and reasonably,so as to improve our ability to deal with the public health crisis.In order to promote the development and improvement of the compulsory patent licensing system,it can effectively protect people’s health.It is urgent to promote the production of quality generics through the introduction of compulsory licensing of patents,given the serious shortage of medicines during sudden major epidemics,which pose a threat to public health and safety.Although the compulsory licensing system for drug patent has been announced in China,it is still in a blank state so far.One of the important factors that lead to this license has never been issued in our country is the lack of compulsory license standards for drug patents and the defects of related legislation.From the legislative level,too strict subject qualification requirements,vague boundaries of the scope of application,too miscellaneous implementation procedures,are urgent problems to be solved.Therefore,the relaxation of the restrictions on the subject of application,the clear scope of application,and the simplification of the procedure license all contribute to the perfection of the compulsory patent license system.There is hope that the problem will be improved by making it easier for patients to get the most widely used drugs in a timely manner.In the face of sudden major outbreaks,it is necessary to develop an efficient approval and adjudication process for compulsory licensing of drug patents as soon as possible.Good implementation of compulsory drug patent licensing also depends on appropriate cooperation mechanisms,including financial incentives for generic drug manufacturers and expedited approval processes for generic drugs to market,incentives for parallel imports and restrictions on reverse payments,enhanced consultation on drug prices between governments and generic drug manufacturers,and expansion of national drug research and development systems.