Comparative Study On Legal Protection Of Drug Test Data

There is a conflict between the urgency of treatment and prevention in the face of global epidemics and the uncertainty of research and development in clinical trials.In this context,the interests of original drug research enterprises,generic drug enterprises,drug regulatory authorities and the public are also in conflict.The premise of drug approval and production is to prove the safety and effectiveness of drugs.The drug test data in drug research and development is the top priority for original drug research enterprises to obtain market competitive advantage and market monopoly.Then drugs can be protected by patent,how to protect drug test data and how to balance the interests of all parties are the issues to be discussed in this paper.The huge initial investment and long return cycle of drug research and development are restricting drug innovation.The main research and development cycle is in the clinical trial stage.Clinical trials are needed to determine the safety and effectiveness of drugs.Pharmacokinetic,toxicological and drug clinical studies of animals and humans are needed.Clinical trial data is the premise for the approval and listing of drugs.If the trial data is not protected,generic drug manufacturers will have a "free ride" phenomenon in the process of innovative drug application for listing.If it is not restricted,it will not only crack down on drug research and development,but also easily cause confusion in drug market,which is not conducive to public health.However,excessive protection of the monopoly right of new drug producers is not conducive to the economic development of the pharmaceutical industry,and inhibits the listing of generic drugs,which can not reach the accessibility of new drugs.The monopoly of new drugs will lead to unreasonable price of new drugs,and the public can not afford the price of new drugs,which has no promoting effect on public health.Therefore,we should find a reasonable and proper way of protection,which can not only protect the enthusiasm and interests of new drug developers,but also ensure the availability of drugs and the economic development of the pharmaceutical industryIt is of great theoretical significance to study the protection system of drug test data through the relevant provisions of TRIPS Agreement,TPP Agreement,European and American exclusive protection mode of drug test data market,and Japanese special protection mode.The legal attribute,protection basis and protection scope of drug test data need theoretical research and analysis.Combining with the balance of interests of various countries and regions to break through the existing protection mode and find a more suitable protection mode,and combining with the revision of drug registration management measures and the draft of drug test data protection in recent years,it can reflect the policy orientation of innovative drugs and the importance of drug test data protection in China.It is necessary to study and discuss which protection mode should be adopted from the perspective of market competition and public interest of exclusive protection of drug test data based on national conditions.The research method to be adopted in this paper is mainly comparative analysis,analyzing the protection strength of different protection modes in different countries to explore whether the protection mode of drug test data is reasonable and legitimate.Through the analysis and comparison to explore whether the current policy of drug test data protection is reasonable,the need to solve is to find a suitable protection mode for drug test data in China.