A Study On The Protection System Of Pharmaceutical Test Data

Protection system for pharmaceutical test data is established by the government by giving the innovator drug companies a certain period of data exclusivity for their test data which submitted for obtaining marketing approvals.This protection aims at preventing their test data from being commercially unfair used by other entities and compensating those companies for their research time and cost.After the expiry of the protection period,other generic companies can rely on data submitted by the innovator drugs companies to get marketing approval for relevant generic drugs.This system is developed under the international background of medical industry.Besides,the initial purpose of setting up this system is encouraging pharmaceutical research and development as well as promoting development of public health.As different countries and regions have diversity in their development levels of medical industries and pharmaceuticals research capacity,the laws and regulations related to pharmaceutical test data are different.The issue behind this system is not just the difference between legislative rules,but also other complicated causes such as industrial development levels.This article takes legislative rules of international economic and trading rules as well as domestic regulations and practices as research objects.This article focus on analyzing legislation rules and practicing procedures comprehensively.Rules on pharmaceutical test data protection are not only stipulated in domestic regulations,but also included in international or regional trade rules.Therefore,this article will discuss current situation and future trends of test data protection by analyzing specific definition and scope of rules and practice of different countries.Moreover,this article will provide suggestions on improving this system under the background of current revising medical regulations in China.The main content of four chapters is as follows.The first chapter will introduce some base theory on pharmaceutical test data such as definition,category,background and legal nature.The first section will analyze definition and categories of drugs and pharmaceutical test data as well as background of the protection system.The second section will discuss the legal nature of test data and the difference between test data and commercial secrets and patents.The third section will analyze both active and negative influence of this system.The second chapter will introduce this protection system in the international economic and trade rules.The first section will discuss requirements and obligations under article 39.3 of TRIPS agreement.The second section will compare basic requirements,requirements,exceptions,and time limit of different trade rules.The third section will discuss the trend of expansionary of drug test data protection system under TPP agreement.The third chapter will introduce relevant regulations and practice in several countries and regions.The first chapter will mainly discuss this system in the Unites States which is the leading country on establishing this system.The second chapter will analyze the legislation and practice of European which has a high-level protection system.The third section gives an introduction on other countries like Canada and Japan as well as some developing countries.The chapter will comment on the protection practice of different countries accordingly.The fourth chapter will discuss the current situation and future trend of the protection practice in China.The first section introduces background and basic legislation of this system in China.The second section analyses ongoing practice in the background of recent revision of drug administration regulations.The third chapter focus on problems and referential suggestions of the substantial rules and procedures.