The Protection Of Drug Test Data During Post-TRIPS Period

Drug is a special commodity that is closely related to vital issues such as human health,social stability and environmental protection.The government departments of the vast majority of countries in the world regulate the marketing approval of pharmaceutical products to ensure the safety and effectiveness of medicines.In the pharmaceutical companies to apply for drugs listed,the corresponding government departments are required to submit their drug test data to prove that the drug through clinical trials can prove the safety and effectiveness of the drug.Therefore,drug test data that pharmaceutical companies to submit contains huge commercial value.Article 39 paragraph 3,of the Agreement on Trade-Related Aspects of Intellectual Property Rights,which was in force in 1995.First agreement protecting data among multilateral trade agreements.Requiring the drug regulatory authorities of the Member States to protect the test data submitted by the pharmaceutical company against unfair commercial use or disclosure.However,the TRIPS Agreement only minimizes the protection of the drug test data in principle.This has resulted in a more comprehensive protection of drug test data in the post-TRIPS period after the TRIPS Agreement,in the domestic legislation of the Member States and in the free trade agreements between States.In this thesis,the first chapter summarize the test data of the drug and the provisions of the TRIPS Agreement on the drug test data.In order to highlight the necessity of the protection of the drug test data during the post-TRIPS period,the writing value of this paper.In the Chapter Two,the protection of the high standard of drug test data in the post-TRIPS period is mainly reflected in the expansion of the interpretation of the original TRIPS agreement,and the protection of the type of protection and the formation of the drug test data protection system.In the post-TRIPS period protect a special drug for data protection,is the third chapter of the main biopharmaceutical test data protection.The need for the protection of biopharmaceutical test data by the distinction between biopharmaceuticals and chemicals,as well as the legislative development of biopharmaceutical test data in developed and developing countries during the post-TRIPS period,and the first time in the latest multilateral trade agreements,Biopharmaceutical test data is specified separately.The Chapter Four mainly suggest China how to carry out domestic legislation and participate to regulate the international rules on drug test data in this high standard of protection of drug test data environment,after the previous discussion on the post-TRIPS period of drug test data protection of higher standards,more comprehensive protection.Finally,it was concluded that in the post-TRIPS period,the drug test data generally generates a higher standard protection and were more comprehensive.China,in this high standard background,not only to choose their own suitable drug test data protection system,and also promote our characteristic drug-Traditional Chinese medicine to the world to form of our own characteristic drug test data protection system.And also can participate in the development of international drug test data protection rules.