Research On The Data Protection System For Drug Trials

Pharmaceuticals test data protection system is a new intellectual property rights system for drugs.Article 39(3)of TRIPS Agreement stipulates it as an international obligation for the first time.Due to the intangible,proprietary and regional property characteristics of pharmaceuticals test data,there is no doubt about its property right attribute.However,different countries have different views on the interpretation and legislative practice of the minimum protection standard stipulated in article 39(3)of TRIPS agreement.Since China’s accession to the WTO,in order to fulfill the obligations under TRIPS,relevant legislation has been carried out on the protection of pharmaceuticals test data.This paper intends to analyze the current situation of China’s legislation from the perspective of TRIPS and with reference to the legislation of other countries,and puts forward relevant suggestions for the improvement of future legislation.Specifically,this paper is divided into four parts:The first chapter mainly introduces the basic theoretical problems involved in this paper.Firstly,the origin and development of pharmaceuticals test data protection are introduced.Secondly,it defines the connotation of pharmaceuticals test data and the intellectual property of pharmaceuticals test data protection,and makes a comparative analysis with the patent.Finally,the influence of pharmaceuticals data protection system on public health is discussed.The second chapter mainly introduces the different rules of pharmaceuticals test data protection in different countries,including the conditions,mode and duration of pharmaceuticals test data protection.The protection condition mainly analyzes different understandings of “data submitted without market approval”,“containing New Chemical Entity”,“Considerable Effort” and “not disclosed” stipulated in TRIPS.The different modes of protection reflect the different legislative choices of different countries,which mainly include the mode of bans on misappropriation,the mode of cost-sharing approach to registration data,the mode of exclusive data and the mode of public health variants of data exclusivity approach.For the duration of protection,currently also adopt different provisions,there is no unified standard.Chapter three analyzes the limitation system of pharmaceuticals test data protection.Firstly,it defines the limitation on the protection of pharmaceuticals test data.secondly,it analyzes the limitation system stipulated under TRIPS.Finally,itcompares and summarizes the legislative practice of various countries and summarizes the main limitation rules.The fourth chapter analyzes the current situation of the pharmaceuticals test data protection system in China,introduces the relevant laws and regulations of the pharmaceuticals test data protection system in China and the deficiencies.The second section tries to make suggestions on improving the protection system of pharmaceuticals test data in China on the basis of drawing lessons from the legislative experience of other countries.