Should China Implement Compulsory Drug Patent Licenses? - From the Perspective of COVID-19
Abstract
Although China has already issued laws and regulations on compulsory licensing of pharmaceutical patents, it has not yet implemented specific practices. After the outbreak of “COVID-19”, realistic needs have made it urgent for China to implement compulsory drug patent licensing. Therefore, this study will be based on China’s national conditions, combined with China’s laws and regulations on the compulsory licensing of pharmaceutical patents, and compare specific practices in other countries. Through qualitative analysis, it’s clear that China implements compulsory pharma ceutical patent licensing in three aspects: domestic system, international level, and government responsibility. To analyze the feasibility of China’s drug patent compulsory licensing system and provide suggestions.
References
China’s “Drug Administration Law”: “For the treatment of severely life-threatening diseases without effective treatment and drugs that are urgently needed in public health, the clinical trials of drugs that have data that have shown the efficacy and can predict their clinical value can be approved with conditions.”
Article 20 of Chapter 2 of the Vaccine Administration Law of the People’s Republic of China: “For vaccines that are urgently needed in response to major public health emergencies or other vaccines that are urgently needed by the health authority of the State Council, the benefits outweigh the risks after evaluation, the State Council’s Drug Administration Departments may conditionally approve vaccine registration applications. In the event of a particularly major public health emergency or other emergencies that seriously threaten public health, the health authority of the State Council will make recommendations for emergency use of vaccines based on the needs of the prevention and control of infectious diseases. It can be used urgently within a certain range and time limit after the management organization organizes the argumentation.
Article 49 of the Patent Law: “When a state of emergency or emergency occurs in the country, or for the purpose of public interest, the Patent Administration Department of the State Council may grant a compulsory license for the exploitation of invention or utility model patents.”
Copyright (c) 2021 Yanlin lv, Yinan Zhang
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