In this Two Sessions, Li Jie, the deputy to the National People's Congress and the chairman of Renfu Pharmaceutical Group, appealed to improve the protection system of drug trial data and strengthen the protection for intellectual property rights in drug research and development so as to response to the lack of supervision in China’s drug system. Due to the pressure of R&D of new drugs which is caused by high input and low output, it is helpful for government to establish a data protection system for drug trials and speculate different protection periods for different types of drugs to protect the outcomes of drug research and development, promote the drug innovation and the development of pharmaceutical industry.

Drug trial data refers to the non-clinical and clinical trial data related to drug effectiveness in the data package of drug marketing registration application documents submitted by drug marketing applicants as required. Although there is no unified drug test data protection standard arounf the world, many developed countries and regions like America and Europe have established drug test data protection systems, providing corresponding protection periods to different types of drugs to protect the drug research and development achievements of related companies.

In contrast, apart from the Implementation Measures for the Protection of Drug Trial Data (Interim) (Draft for Comment) published in 2018, there are no relevant supporting rules and regulations in China so far. With regard to the Implementation Measures, although it indeed provides different data protection periods for different drug types, the types of drugs included are not comprehensive and the regulatory mechanism and legal consequences are not mentioned, which cannot effectively protect the rights and interests of new drug applicants.

In view of that, Li Jie suggested that more measures should be taken on the basis of the Implementation Measures to further promote the implementation of the protection for drug trial data. For example, we could increase the types of protection objects of clinical trial data, including improved new drugs and generic drugs that meet the standards. At the same time, different protection periods should be set for different types of drugs, referring to the practices of the United States, Japan, Europe and other countries and regions to improve the specific standards and rules in our country's drug trial data protection system.