Research On Protection Of Pharmaceutical Testing Data

This article aims to study the protection system of drug test data,try to analyze the relevant expressions in the TRIPS agreement,and conduct comparative studies on the national drug testing data protection systems,to explore and improve the effective way of China's drug testing data protection system.The introduction proposes the research topic,significance and research methods of this article.Please find the summary of this article as below:The data protection system for drug trials has not been widely disseminated in China.Therefore,the first chapter of this article mainly discusses the basic theoretical concepts of this article.In the first section,the drug development process is mainly combined with relevant basic concepts-drug test data and drug testing data protection system,to lay a solid foundation for the full text of the discussion.The second section mainly discusses the intellectual property attributes of drug test data and compares it with traditional intellectual property rights.It mainly compares the differences and links between patent protection and trade secret protection,thus demonstrating its special knowledge.The attribute of property rights reflects the independent role of protection that is different from the protection of pharmaceutical patents and the protection of trade secrets of pharmaceuticals.The second chapter attempts to analyze the protection system for drug test data under Article 39.3 of the TRIPS Agreement,as the TRIPS Agreement provides theminimum standards for the protection of drug test data as a product of negotiations between developed country members and developing country members.The provisions of the TRIPS agreement cannot be exhaustive,and it can be said that the relevant provisions are more general and descriptive expressions.This ambiguity has also caused a lot of controversy among different countries.Therefore,the chapter attempts to analyze relevant expressions,such as "very hard","not disclosed","not dependent on",and "unfair commercial use." To pave the way for putting forward China's sound suggestions.The third chapter of this article focuses on the research on the data protection system for overseas drug trials.It selects the United States,the European Union,and Japan for analysis,compares the drug testing data protection system with Article 39.3of the TRIPS Agreement,and tries to analyze what China can learn from: protection innovation.,Balancing the benefits of innovative drugs and generic drugs,"non-disclosure" obligations.The fourth chapter of this article mainly analyzes the current situation of China's drug testing data protection system.The first section elaborates on the legal regulation of China's drug testing data protection system.The second chapter analyzes the controversial issues of the protection of the drug testing system.That is,repeatedly submitting drug test data and government regulatory agencies using the drug test data.The third section analyzes the deficiency of China's drug testing data protection system from the levels of substantive law and procedural law.The main problems include unclear objects of protection,infringement of rights,and unclear remedies.The fifth chapter of this paper attempts to propose a solution to the improvement of China's drug testing data protection system.