Research On The Implementation Of Compulsory Drug Licensing System Under Public Health Crisis

The implementation of compulsory drug patent licensing system can greatly improve the accessibility of drugs and effectively deal with public health crisis.China’s compulsory drug patent licensing system has been written into the Patent Law in September 1992 for more than 30 years,but there has never been a successful implementation case.After the outbreak of COVID-19 in China in 2020,relevant data released by the National Health Commission,the China Center for Disease Control and other departments show that COVID-19 seriously endangers public health,and how to "find specific drugs" has become the expectation of the whole people,and the implementation of compulsory drug patent licensing system may provide a feasible way to solve the problem of public drug use.From the perspective of the existence basis of compulsory drug patent licensing system,on the one hand,it has the realistic dilemma based on public health crisis,on the other hand,it has the legal basis of the principle of giving priority to human rights and the balance of interests.Currently,the international treaties related to compulsory drug patent licensing system mainly include TRIPS Agreement,etc.From the perspective of our country,the Patent Law stipulates the compulsory licensing system for drug patent,but there are no successful cases.From the perspective of market subject,although Baiyunshan version of "Tamiflu" event opened the application of compulsory drug patent licensing system,but it was rejected and ended;From the point of view of the state administrative organs,the reply of the State Intellectual Property Office to the proposal on the development of the generic drug industry shows that the relevant departments of The State Council are still facing difficulties in the implementation of compulsory drug patent licensing.On the one hand,institutional norms need to be improved,supporting mechanisms are lacking,specific operations need to be clarified,and coordination mechanisms are not smooth.On the other hand,this is also closely related to our current environment of building an innovation-oriented country and avoiding trade frictions.From the perspective of foreign countries,developed countries represented by the United States and Canada generally resist compulsory license of drug patents,but they will also use compulsory license as a negotiating weight to reduce the price of patented drugs.On the other hand,developing countries such as India,Thailand,Brazil,and South Africa have implemented compulsory licensing of drug patents,but have also been subjected to trade sanctions by developed countries.Considering the implementation status of compulsory drug patent licensing system under public health crisis at home and abroad,it is suggested to improve the system by clarifying the qualification of the applicant,formulating the criteria for judging the application conditions and improving the protection mechanism of the patentee.Meanwhile,the application review procedure is optimized,the termination procedure is perfected and the inter-departmental coordination mechanism is established.In addition,we should increase investment in research and development,strengthen communication and negotiation to improve the access to drugs,and pay attention to enhancing the international voice,so as to contribute to the building of a community of human health.