Study On The Legal Protection Of Pharmaceutical Test Data Under TPP Framework

As a special product which is closely related to human life and health,pharmaceuticals and pharmaceutical industry are closely linked to public health,social development and the environment.In most countries,in order to ensure the safety and efficacy,if one drug wants to grant marketing approval,governments usually require the pharmaceutical R&D enterprises to deliver the drug test data or other data to prove its safety and efficacy.A new drug usually contains huge commercial value,so according to the “minimum standard” provided by TRIPS,many regional trade agreements,as well as national laws provide different standards of protection for the drug test data.In October 2015,the TPP Agreement which is led by the United States and includes 12 countries was finalized.It covers 40% of the world's economic entities and raises higher requirements and standards of intellectual property protection related to the pharmaceutical industry.Although the United States has withdrawn the TPP in January 2017,nothing to do with the US withdrawal is the TPP Agreement reflects the international trend of the drug test data protection and the current attitude of the countries.The future of TPP does not affect the nature of its text.The future bilateral,regional and multilateral negotiations can not be separated from the TPP text,because this is a typical "path dependence" phenomenon,and the negotiators will naturally refer to this text.As China's bilateral or regional free trade agreements with TPP members are increasing,TPP rules(including IPR rules)may also penetrate into these agreements.Even there is possibility that China will join the TPP or absorb the TPP rules to China's leading regional free trade agreement.This thesis combines the final text of the TPP and its negotiation process,as well as the drug test data protection of TRIPS and some western countries,to analyze the drug test data protection under the TPP framework,explore the development of drug test data protection and the influence on China.Finally this thesis puts forward some ideas and suggestions.Besides the introduction,this thesis includes four parts,:Part?:Elaborates the general theory of the drug test data protection,which is divided into three parts:the interpretation of the basic concepts,the nature of the legal protection of the drug test data and the relationship with public health.The main content is the theoretical analysis of the”data exclusivity”under the TPP framework.Part?:Analyzes the emergence and development of drug test data protection under TPP,including the background of the negotiation and the formation of the text.Through the four texts related to IPR leaking during the negotiation process,analyzes the changes of drug test data protection in TPP negotiation and the main dispute among members and paves the way for the concrete content in next part.Part?:Elaborates the provisions of drug test data protection of TPP Agreement,including four parts:the protected object,the duration of the protection,exceptions and remedies to rights and the special protection of biologics.In the process of the analysis,it is found that TPP has some problems in the protection of drug test data by comparing with the regulations in the US and EU and TRIPS.Part?:This part focuses on the enlightenment from the drug test data protection system of TPP framework.Fist of all,it analyzes the current status of the drug test data protection system and its existing problems in China.Then analyze the potential impact on China and give some suggestions and thoughts with regard to the countermeasures.