Research On Legal Protection Of Drug Trial Data Under The TRIPS Agreement

Drug trial data is generated during the development process of drugs and is used as factual evidence to prove the efficacy,adverse reactions,and other aspects of drugs.If pharmaceutical companies want to obtain safe and effective experimental data,it often takes decades of time and a large amount of personnel and capital investment.Under the current drug approval system,it is allowed for generic drugs to use experimental data submitted by previously marketed original drugs during the application process,which is generally referred to as a "free riding" phenomenon.In order to balance the competitive pressure brought by the rapid approval process of generic drugs on original drug research enterprises and motivate them to innovate,it is necessary to protect drug test data.Based on the provisions of Article 39.3 of the TRIPS Agreement,this article provides a detailed introduction to the regulations of the TRIPS Agreement on various aspects of drug trial data protection.The minimum protection obligation required by TRIPS in this protection object is to take effective measures to prevent competitors from dishonestly using undisclosed trial data of the original drug,and to ensure that the trial data is not disclosed,Data can be disclosed based on the needs of the public interest and measures taken to prevent improper commercial use.However,in the post TRIPS era,the provisions of the TRIPS agreement on drug trial data were gradually broken by bilateral or multilateral free trade agreements.Countries such as Europe and America promoted the exclusive protection system of drug trial data to other countries through forum transfers,such as bilateral forums.This system believed that the act of drug approval agencies reviewing generic drug data by referring to the original drug data and allowing generic drugs to be listed on the market was unfair,it should be prohibited and the protection conditions stipulated in the TRIPS agreement have been removed,the exclusive protection period has been extended,and the protection standards for drug test data have been raised.China has already granted a 6-year legal protection period for drug trial data,and has also issued a series of opinion drafts that draw on the experience of Europe,America,and other countries to continuously reform the legal protection of drug trial data.However,relevant laws and regulations have not been truly implemented.Next,China needs to accelerate the implementation of legislation in order to provide effective protection for drug trial data.