The Legal Protection Of Pharmaceutical Test Data In China

On April 25,2018,the National Medical Products Administration(NMPA)published the Measures for the Implementation of Pharmaceutical Test Data Protection(Exposure Draft)and solicited opinions from the public.This is the first specific legal document for the protection of pharmaceutical test data issued by China after the establishment of pharmaceutical test data protection for China’s accession to the WTO.This paper analyzes the nature of pharmaceutical test data protection in China which is considered as TRIPs-plus obligation.The author also reflects on such mode of pharmaceutical test data protection which is selected by China,point out problems of China’s pharmaceutical industry and pharmaceutical test data protection,and propose corresponding suggestion aimed at amendments to the "Exposure Draft" and improving regulations on the legal protection of pharmaceutical test data.The first part provides an overview of the definition of pharmaceutical test data and the reasons for its protection.The drug test data mainly refers to various test data obtained at different stages of drug development to determine the performance of the drug(including but not limited to the safety,stability,effectiveness,etc.of the drug),including preclinical and clinical trial data.This part elaborates the legitimacy of protection from the characteristics of of drug test data and the relationship between private property and public interest.In the second part,the author sorts out and analyzes different protection modes of pharmaceutical test data in the world and the protection of pharmaceutical test data in China.This section introduces the pharmaceutical test data protection standards required by the TRIPs Agreement,which is called the anti-unfair competition protection,and the protection of data exclusivity required by the US domestic legislation and the TPP agreement.It also introduces the establishment and development of pharmaceutical test data protection in China.In the third part,based on the discussion of the nature of the data exclusivity,it can conclude that the data exclusivity is only an administrative protection that balances multiple interests,rather than an independent form of intellectual property protection.It is not justified that developed countries advocate the protection of data exclusivity and launch the “301Investigation” because other countries don’t adopt the data exclusivity to protect pharmaceutical test data.What’s more,the protection of pharmaceutical test data adopted by China for accession to the WTO does not meet the national conditions of China at that time,and the data exclusivity has certain adverse effects.In the fourth part,based on the comparison of the status quo of the Chinese and American pharmaceutical industry,the author draws the conclusion that the drug test data protection system can applied in China,and puts forward the problems that need to be solved urgently in the pharmaceutical industry.In the fifth part,the author analyzes some of the provisions in the “Exposure Draft” that are not conducive to solving the existing problems in China’s pharmaceutical industry.Based on the US domestic legislation and the TPP agreement,the author gives the opinions on the revision of “Exposure Draft” and the solutions of false pharmaceutical test data problems to improve the legal protection of pharmaceutical test data in China,strike a balance between innovative drug companies and generic drug companies,pharmaceutical companies and consumers,and promote the healthy development of China’s pharmaceutical industry.