(Characters of the two sessions) Li Jie, deputy to the National People's Congress: Improve the data protection system for drug trials
China News Service, Wuhan, March 5 (Reporter Ma Furong) At the National Two Sessions currently being held, Li Jie, a representative of the National People's Congress and chairman of Renfu Pharmaceutical Group, called for improving the data protection system for drug trials and increasing the protection of intellectual property rights in drug research and development.
"New drug research and development is a field with high input and low output." Li Jie said that there are three "ten" statements in the industry, that is, a ten-year research and development cycle, an investment of one billion yuan, and a success rate of only 10%. The investment is mainly in the acquisition of drug test data, so these data have high economic value.
In Li Jie's view, the establishment of a drug trial data protection system to provide corresponding protection periods for different types of drugs plays an important role in protecting the results of drug research and development, promoting drug innovation, and promoting the development of the pharmaceutical industry.
Li Jie pointed out that at present, apart from the "Implementation Measures for Drug Trial Data Protection (Interim) (Draft for Comment)" issued by the State Drug Administration in April 2018, there are no relevant supporting rules and regulations, which have affected drug trials. Further implementation of data protection work.
With the continuous enhancement of the innovation ability of Chinese pharmaceutical enterprises, it is imperative to implement the drug trial data protection system.
He suggested that, on the basis of the "Implementation Measures for the Protection of Drug Trial Data (Interim) (Draft for Comment)", the protection objects of clinical trial data should be increased, including improved new drugs, and the data obtained by self-obtained test data to prove the safety and effectiveness of drugs. Generic drugs for which a marketing application has been submitted.
At the same time, referring to the experience of the United States, Japan and other countries and regions, different protection periods are set for different types of drugs.
For example, improved new drugs have a 4-year protection period, innovative drugs and children's drugs have a 6-year protection period, rare disease drugs have a 7-year protection period, and innovative biological drugs have a 12-year protection period.
In addition, a 4-year protection period is established for generic drugs that submit marketing applications based on self-obtained test data proving drug safety and efficacy.
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