The Research On The Issues And Legal Countermeasures Of Drug Trial Data Disclosure

This article focuses on the theoretical and practical dilemmas faced by drug trial data disclosure and runs through the full text from the perspective of achieving "accessibility".Through theoretical research,text interpretation,and institutional analysis,this paper discusses the legal issues arising from the disclosure of drug trial data in the drug research and development process in the data era and proposes legal responses to the optimization of its institutional settings.The introduction of this article examines the practical significance and academic value of the research on drug trial data disclosure issues in combination with literature research.At the same time,by sorting out and analyzing the current domestic and international academic research on legal issues related to drug trial data,it proposes the research gaps that need to be filled and explains the structural arrangement of this article.Firstly,theoretical overview.Point out the types of data generated by the application of artificial intelligence in the field of drug research and development,so as to find the connection point between drugs and data,leading to the main discussion object of this article,namely,drug test data.Through analysis,the theoretical scope of the drug trial data discussed in this article is limited,providing a basis for the subsequent institutional setting.Secondly,question raising.On the basis of limiting the theoretical scope of the previous article,the legal issues related to drug trial data-the legal nature of drug trial data,the difficulty of its disclosure interests,and institutional disputes-are proposed.Thirdly,focuses on the first legal issue,seeking to break through the legal dilemma of drug trial data disclosure.This article discusses the legal attributes of drug trial data,analyzes its current object positioning of rights,analyzes the nature of its intellectual property rights,and proposes that it should be treated as a unique type of intellectual property rights,rather than simply treated as a trade secret,data monopoly,or data property object.Fourthly,focuses on the second legal issue to address the value dilemma of drug trial data disclosure.With its role in empowering drug accessibility and data accessibility,it provides evidence of the value of drug trial data disclosure.The concepts of drug accessibility and data accessibility were thoroughly analyzed.The importance of drug accessibility for the realization of human rights under the right to health was elaborated,as well as the contradictory relationship between the guarantee of drug accessibility and the data legal system;Introduce the concept of data accessibility and demonstrate the key role of data disclosure in improving data accessibility.On this basis,the legal logic and ethical logic of two-way empowerment of data accessibility and drug accessibility are summarized.Based on the principle of "consideration equity",this paper discusses the rationality of intellectual property rights in the disclosure of drug test data,and in combination with the specific provisions of the TRIPs agreement,responds to the legal issues raised earlier on the legality of the disclosure of drug test data,and lays a theoretical foundation for future research on its disclosure.Finally,focuses on the third legal issue,which is also the core expectation of this article to solve the dilemma of drug trial data disclosure system.Starting with the relevant policies for drug trial data,first of all,it is necessary to clarify China’s current international obligations to protect drug trial data.Then,it summarizes the development and trend of the current disclosure system settings.By analyzing the advantages and disadvantages of the three different disclosure models proposed in the previous article,it provides suggestions for the selection of their drug trial data disclosure models.Based on the perspective of accessibility,it is proposed that the primary and ultimate regulatory goal should be to promote "disclosure after expiration of protection" until "active disclosure after authorization".Based on the previous discussion,suggestions are made for the refinement and improvement of the current "Implementation Measures for the Protection of Drug Test Data(Provisional)"(Draft for Comments).The conclusion part extracts the key points of each chapter to demonstrate the core issue of the drug trial data disclosure system supported by this article’s viewpoint: to construct a legal order for data disclosure that conforms to legal principles,considers the interests and demands of all parties,and is practical and feasible,in order to ensure data accessibility,promote drug accessibility,and maximize the value of drug trial data disclosure.