The Study Of Chinese Drug Data Protection

Conflicts of interests between developed countries and developing ones are oftenreflected by the protection of intellectual property (IP). The Uruguay Round for thefirst time involved this field in multilateral trade system, and finally came to TheTRIPS Agreement with powerful protection and binding force. Article39.3of theTRIPS Agreement explicitly requests protection for Pharmaceuticals data. Byproviding brand-name drug with a particular period of time to monopoly the market,Pharmaceuticals data exclusivity insures cost callback in a high profit of OriginatorCompany with stimulating Pharmaceuticals development as a result. After theexpiration of protection, generics companies are entitled to use the originator’s datafor applications of generic drugs. Strictly speaking, Pharmaceuticals data exclusivityis aimed to maintain the balance of interests between brand-name drug and genericdrug. However, Pharmaceuticals data exclusivity is a double-edged sword. Overlytough protection tends to result in a long-term monopoly market of brand-name drug,which in turn leads to high prices and low accessibility of drug. On the contrary, thelack of effective Pharmaceuticals data exclusivity would give rise to the increase of“free-riding” and unfair competition, which may dampen developers’ initiatives.This dissertation presents the generation of Pharmaceuticals data exclusivity systemfrom a historical perspective, analyzes Pharmaceuticals data exclusivity and severalnational legislations under the TRIPS Agreement and various American Free TradeAgreements, and hopefully could provide a reference for China’s Pharmaceuticalsdata exclusivity system. This dissertation consists of six parts apart from introductionand epilogue.The First chapter is the conspectus of Pharmaceuticals data exclusivity. The authorintroduces the source and value of Pharmaceuticals data exclusivity and then thegeneration of such protection system.The second chapter is about the theoretical foundation and the significance ofPharmaceuticals data exclusivity. The author firstly stresses the legitimacy andnecessity of the Pharmaceuticals data exclusivity and then reveals the nature of it, andmeanwhile points out the influence imposed on the pharmaceutical industry by such protection. The author also suggests his opposition against gaining access toPharmaceuticals data prior to the expiration of protection.The third chapter is about the Pharmaceuticals data exclusivity under the TRIPSAgreement and American Free Trade Agreements. First, the author describes thelegislative background of the Pharmaceuticals data exclusivity under the TRIPSAgreement and analyzes the five conditions of Pharmaceuticals data exclusivity underThe TRIPS Agreement. This is followed by a brief introduction to thePharmaceuticals data exclusivity under various American Free Trade Agreements.The fourth chapter is about the legislation of Pharmaceuticals data exclusivity inadvanced pharmaceutical market and emerging ones. First, the advancedpharmaceutical market is represented by the U.S and EU, while the emerging marketby India and Mexico. Moreover, the author gives an introduction on the legislation ofPharmaceuticals data exclusivity in Canada and Taiwan.The fifth chapter is about Pharmaceuticals data exclusivity and public health.The sixth chapter is focused on the problems and countermeasures of China’sPharmaceuticals data exclusivity. The author introduces the status quo of China’slegislation of Pharmaceuticals data exclusivity and points out some problems existingin China’s Pharmaceuticals data exclusivity as well as some feasible suggestions.