Research On The Protection System Of Pharmaceutical Test Data

Pharmaceutical test data is the data submitted by pharmaceutical companies to prove the safety and effectiveness of drugs during marketing approval at the request of the drug regulatory authority.It can be said that the pharmaceutical test data is the proof of the original drug company’s marketing authorization,which condenses the wisdom and sweat of the original drug company,and has huge economic value.It is an important weapon for the original drug company to gain market competitive advantage.Under the ANDA process for generic drugs,failure to protect pharmaceutical test data will result in a large number of generic drug companies free-riding during marketing approval,which will severely weaken the enthusiasm of the original drug companies to engage in new drug research and development,and it is also easy to cause confusion in the marketing of drugs,which is ultimately detrimental to public health.The pharmaceutical test data protection system is a new type of intellectual property system,which originated from the domestic law of the United States and was promoted to the international level by the TRIPS Agreement.The system sets a certain period of exclusive rights for data holders,within which the relevant data is excluded from being used by unauthorized parties,and investors are guaranteed to recover capital and make profits.It can effectively balance the vital interests of the original drug companies,generic drug companies,and the public,and has a profound impact on new drug research,generic drug development and public health.Ensuring the establishment and effective implementation of a pharmaceutical test data protection system is a common obligation of WTO member states,which is of great significance to the public health safety of our country and the world.Currently,our country lacks a pharmaceutical test data protection system that can be implemented.In order to fulfill the WTO commitments,the Regulations for the Implementation of the Drug Administration Law revised in 2019 retains the principled regulations on the protection of pharmaceutical test data,which lacks operability.First,the application conditions of the system are not clear,which is easy to cause differences in identification;second,the scope of application of the system is relatively narrow,which does not meet the current development needs of our country’s pharmaceutical industry;third,the system lacks reasonable procedural regulations,resulting in the inability to give full play to the role of the system;finally,the connection between this system and the drug patent protection system is not strong,which may easily hinder the implementation of existing laws related to drug patents.Relevant detailed regulations remain at the stage of the Implementation Measures for the Protection of Pharmaceutical Test Data(Interim)(Draft for Solicitation of Comments)issued by the Drug Administration in 2018.Although this is the most detailed text so far,there are still many problems and it is in the stage of institutional conception.In the context of our country’s pharmaceutical industry calling for innovation,it is recommended that our country speed up the exploration process of the pharmaceutical test data protection system,and implement the operable Chinese characteristic pharmaceutical test data protection system as soon as possible.The main body of this paper is divided into four chapters.The first chapter focuses on expounding the value and significance of the pharmaceutical test data protection system and the shortcomings of our current system,and puts forward the key questions to be studied in this paper.First,our current system is not perfect in terms of protection conditions,protection scope and protection procedures.Second,the current system lacks a coordination mechanism with the drug patent protection system.The second chapter discusses the controversy over the pharmaceutical test data protection system under the TRIPS Agreement,and then analyzes the new development of relevant legislation and international trade rules to clarify the latest requirements and international trends of the system,and further examines the implementation of typical countries,and summarizes useful experience for our country to improve the current system.The third chapter aims to explore the coordination method under the parallel protection of pharmaceutical test data and drug patents.Demonstrating the rationality of introducing compulsory licenses for pharmaceutical test data protection system through interpretation of the Doha Declaration.Seeking a way to coordinate the two systems in our country through investigating the practice of countries with both the pharmaceutical test data protection system and the drug patent linkage system.The fourth chapter on the basis of the aforementioned research,focuses on the Implementation Measures for the Protection of Pharmaceutical Test Data(Interim)(Draft for Solicitation of Comments),from the protection conditions,protection scope,protection procedures,and coordination with the drug patent protection system of the pharmaceutical test data protection system,puts forward practical countermeasures and suggestions.