Third trial of draft vaccine management law

[policies and regulations of pharmaceutical Station] on June 25, the third trial of vaccine management law (Draft) was held As a special legislation in the field of vaccine management, the third draft will increase the penalties for illegal acts of vaccines, increase the amount of fines, and increase the types of penalties It is suggested that the compensation scope and step standard be further clarified to guarantee the compensation cost It is suggested to make the following modifications: first, to increase the provisions, the compensation system for abnormal reactions of vaccination should be timely, convenient and reasonable; second, to increase the provisions, the scope of compensation should be subject to catalogue management, and dynamic adjustment should be made according to the actual situation Third, the State Council shall specify the scope, standards and procedures of compensation, and the provinces, autonomous regions and municipalities directly under the central government shall formulate specific implementation measures; fourth, the financial departments of the people's governments of the provinces, autonomous regions and municipalities directly under the central government shall make clear the compensation expenses needed for vaccination, which shall be arranged by the financial departments of the people's governments of the provinces, autonomous regions and municipalities directly under the central government Some people also proposed that we should further improve the legal liability, increase the punishment for illegal acts of vaccines, increase the amount of fines, increase the types of penalties, and supplement the legal liability for some illegal acts It is suggested to make the following modifications: first, make it clear that those who violate the provisions of this Law and constitute a crime shall be investigated for criminal responsibility in accordance with the law; second, the vaccines produced and sold are illegal acts such as fake drugs and substandard drugs, and increase the penalty on the responsible units and personnel The third is to increase administrative detention for those responsible for serious illegal acts; Fourth, for the illegal behaviors such as unauthorized production of vaccine commissioned by the listing license holder or failure to establish an electronic vaccine traceability system in accordance with the regulations, collection, tracking and analysis of suspected abnormal vaccination reactions, failure of disease prevention and control institutions and vaccination units to provide traceability information in accordance with the regulations, failure of guardians to ensure that school-age children receive the vaccine on time in accordance with the law, etc., the corresponding laws are added Legal responsibility The author understands that in the second trial of the draft on April 20, the draft expanded the scope of compensation for abnormal reactions, and made it clear that the death, serious disability, organ and tissue damage of the recipient occurred during or after the implementation of vaccination, which belongs to the abnormal reactions of vaccination or can not be excluded, should be compensated Experts said that although the second review of the draft made clear the direction of compensation for abnormal reactions, it still needed to further improve and refine the relevant system Experts suggested that we should draw lessons from the experience of the United States, Japan and other countries to formulate the "vaccine damage compensation table of immunization program" in China   In fact, there is a long-standing debate about whether the "vaccine safety issue" leads to punitive damages Some scholars believe that in order to ensure the sanctions and deterrence function of punitive damages, it is not appropriate to uniformly stipulate the amount of damages in the country Due to different development levels in different regions, if the high amount of punitive damages is affected, punitive damages will be difficult to impose sanctions on some people in some regions And containment However, some scholars also said that the amount of punitive damages should have a clear limit, otherwise, in the case of domestic judicial power seriously disturbed by various factors, it is easy to determine the damages at will and other judicial unfair phenomena Before that, the most important document in the field of vaccine was Decree No 668 of the State Council issued and implemented in 2005 and revised in 2016, regulations on the administration of vaccine circulation and vaccination The upcoming vaccine management law will also become a more law in the field of vaccines It will also comprehensively strengthen the supervision of the whole chain of vaccine research and development, production, circulation and use, improve the level of supervision, ensure product quality, and promote the continuous progress of the whole vaccine industry.