Research On Drug Trial Data Protectio

In 1984,the US enacted the Hatch-Waxman Act,which was the first in the world to establish a clear system for the protection of pharmaceutical trial data,and for the first time proposed a certain period of exclusive protection for original research and development companies that had spent a lot of money on it.In 1995,Article 39.3 of the TRIPS Agreement defined undisclosed pharmaceutical data as a trade secret,which could be considered as protected under unfair competition law,and this practice became the international standard for a long time.However,there are different positions on the interpretation and legislative practice of this paragraph in different countries.Since China’s accession to the Agreement,in order to fulfil its obligations under the TRIPS Agreement,relevant legislation has been enacted for the protection of pharmaceutical trial data,and although there are some shortcomings in terms of time limits,regulatory efforts and information disclosure,the overall situation is still moving towards improvement.In this paper,we analyse the legal nature of the drug trial data system,the current development of China’s drug trial data protection system,review the current overseas protection models,and conclude with suggestions for the improvement of China’s drug trial data protection system.Chapter 1 introduces the concept of pharmaceutical trial data and the four protection models used in different countries,and through the development of pharmaceutical trial data protection,concludes that the protection standard of pharmaceutical trial data protection is increasing.By analysing the characteristics of the three similar systems,it is further clarified that the pharmaceutical trial data protection system cannot be equated with these two existing systems and requires an independent protection model.Chapter 2 puts forward the current deficiencies of China’s drug trial data protection system by analysing the background,development history and current situation of the system.For example,the problems of imperfect duration,diversified objects of protection,ambiguity of regulations,insufficient supervision,unclear restrictions and incomplete information disclosure.Chapter 3 is a review of Chapter 18 of the TPP Agreement,which currently has a high standard of protection,through a detailed understanding of Article 39.3 of the TRIPS Agreement from an international perspective,and a consideration of the direction that China should choose in the trend of globalisation.And by examining the drug trial data protection systems in the US,EU,Japan and Korea,we draw out the highlights that can be drawn from to improve the existing system in China.Chapter 4 is to address the shortcomings of China’s drug trial data protection system and put forward suggestions for improvement.The first is to adopt a flexible protection model,drawing on the segmental protection model of the United States;the second is to determine the meaning of the protection targets;the third is to improve the protection targets by adding traditional Chinese medicine,new indication drugs and improved new drugs;the fourth is to refine the exceptions,proposing non-sale revocation of permission and public health event exceptions;and the fifth is to establish a public channel for trial data to safeguard the public’s right to know.