Study On The Legal Protection Of Pharmaceutical Test Data

At present,the minimum standard of protection of pharmaceutical test data is Article 39(3)of the TRIPS Agreement,and the principle is "non-disclosure and non-reliance",which means not to disclose the pharmaceutical test data to an unauthorized third party and not to approve the launch of generic drugs which is bioequivalent and competitive to the drugs based on the same data.From a pharmaceutical manufacturer's point of view,this model can completely protect its economic benefits out of the possession of the test data,but this is contrary to the public's right to know,especially those who use the drug.Because of the special nature of drugs,it is closely related to the public health right.If the public's knowledge of the drug is restricted to the basis such as its composition and the mechanism of work,it may be unfair to the public,especially under the current situation of frequent corruption in international investments and drug safety incidents,the legitimacy of the "non-disclosure" provision is under doubt,and the controversy between it and the right to know of the public offers me a new direction in studying the legal protection system of the pharmaceutical data,which is that whether we can build such a system of data exclusivity on the ground of data disclosure?To answer this question,I would apply the value analysis method to explore whether the drug test data can be disclosed of its legal nature,and select the most representative TRIPS Agreement on drug test data protection requirements,and apply the historical analysis method to compare it to the provisions in the TPP Agreement.Based on the aforesaid study,I would analyze the defects of China's pharmaceutical test data and suggest that we could build a system to protect the exclusivity of test data based on disclosure.The first chapter outlines the legal nature of pharmaceutical test data,the significance and examples of drug test data protection.Legally defined,it was trade secrets in R&D phase,but once the manufacturer submits such data to a government for license,such data shall be disclosed and known to the public.The protection of pharmaceutical test data shall be aimed to avoiding unfair competition by generic drugs.The significance of legal protection of pharmaceutical test data lies in maintaining the interests of the drug maker and maintaining the balance between the public interest and the interests of the pharmaceutical business.Chapter 2 discusses the legal protection of pharmaceutical test data under the TRIPS Agreement.TRIPS Agreement contains 4 elements on the protection of drug test data from the "protected data type","new chemical entity","after considerable effort","undisclosed" the author in turn analyze and put forward the views that the four elements and drug test data openness does not conflict.Exceptions to the legal protection of drug test data under the TRIPS Agreement,namely,"exceptions to the public interest" and "prohibition of unfair commercial use",include harmonization of public welfare and openness,and in the event of an emergency crisis in the public interest,direct use and disclosure of test data,regardless of the balance of interests.After the test data is made public in the country,the government should take legal means to protect it against "unfair commercial use".Chapter 3 describes the differences in the terms of the drug test data protection agreement in the Transpacific Partnership Agreement(TPP)compared to the TRIPS Agreement,such as the expansion of the object of protection,the provision of the term of protection and the specialization of the relief procedure.Chapter 4 introduces the benefits of TRIPS agreement and TPP agreement to the legal protection system of pharmaceutical test data in China,and points out that there are some defects in the protection system of the existing pharmaceutical test data in China,and a data exclusivity system shall be built on the basis of data disclosure.