Research On Chinese Drug Trial Data Protection System

The drug trial data protection system originated from the domestic law of the United States,and has been specified further in TRIPS.It is related to the important balance of interests between the research and development of new drugs,the market competition of generic drugs,and public health.And it exhibits a profound impact on the interests of original drugs manufacturers(innovative drugs),generic drugs manufacturers,and patients.Drug trial data is the proof for original research drug to apply for coming into the market and getting approved.It is a significant measure for the cooperation and public health of China to ensure the establishment,soundness and effective implementation of drug trial data protection system,which can effectively alleviate the urgency of the prevention of global epidemics.The data embodies the wisdom and hard work of developers with a huge economic value,which have a profound influence on the research of innovative drugs,the availability of drugs,and global public health.Drug trial data is a significant measure for the cooperation and public health of China to ensure the establishment,soundness and effective implementation of drug trial data protection system,which can effectively alleviate the urgency of the prevention of global epidemics.However,Chinese drug trials data protection system was developed lately and basically followed the provisions of Article 39.3 of the TRIPS Agreement.It fails to comply with the new trend of drug test data protection(i.e.,grant exclusive protection of drug trial data),and it cannot effectively protect drug test data.First,the connection between the drug trial data protection system and relevant promulgated laws or regulations is not strong,which easily makes the application of the law difficult;Second,the scope of application of the drug trial data protection system is unclear,which is likely to cause differences in understanding;Third,the exception to the system lacks rationality and does not fit the adopted drug trial data exclusive protection model;Then,the drug trial data disclosure system is vague,and there is no clear explanation of the "data non-disclosure obligation" and other regulations,which hinders the drug trial data protection system from being implemented;Finally,the drug trial data protection system focuses on the responsibility for those who violate the system,and lacks effective remedies for the infringed victim.Therefore,it is recommended that China should speed up the pace of improving the drug trial data protection system,supplement the missing content of the drug trial data protection system,and actively explore the establishment of a drug trial data protection system with Chinese characteristics and in line with national conditions.In turn,it encourages pharmaceutical innovation,promotes the development of the pharmaceutical industry and guarantees public health and welfare.Above all,in order to improve Chinese drug trial data protection system,it is necessary to absorb the experience in the process of protection systems construction and improvement from foreign countries.China can learn from the experience of relevant international trade rules such as TPP,RCEP and China-US economic and trade agreements or the establishment of a representative drug trial data protection system in the United States and Europe.Therefore,it is recommended that Chinese should: First,strengthen the connection with the promulgated relevant laws and regulations to eliminate difficulties in the application of the law;Second,clarify the scope of application of the drug trial data protection system to reduce differences in understanding;Third,formulate compliance Chinese specific national conditions of drug test data protection exceptions to enhance rationality;Fourth,to clarify the specific content of Chinese drug trial data disclosure system,so as to implement the drug test data protection system truly and effectively;Fifth,to increase the infringement of drug trial data rights relief intensity,clarify the remedy channels and responsibilities.Through the above suggestions,it will improve Chinese drug trial data protection system,so that Chinese can participate in cooperation in the international protection of drug trial data legally,reasonably and orderly.