Recently, the Vaccine Management Law (Draft) was submitted to the 11th meeting of the 13th National People's Congress Standing Committee for the third reading. Compared with the second reading draft, the draft proposes to make provisions for the implementation of catalog management of the compensation scope for abnormal reactions to vaccinations, and guarantee the compensation costs. In addition, the draft also further increases the intensity of punishment for vaccine violations, requires severe criminal liability, and increases the types of illegal penalties.

Relevant functional departments should promptly announce the results of vaccine batch release

Some members of the Standing Committee proposed that the provisions on the disclosure of vaccine-related information should be further improved to protect the public's right to know and strengthen social supervision.

Based on this, the National People's Congress Constitution and Law Committee suggested adding provisions that the State Council's drug supervision and administration department should promptly announce the results of the batch release of marketed vaccines and the updated vaccine instructions and label contents.

Abnormal reaction compensation is managed by catalogue

It is worth noting that some members of the Standing Committee, departments, experts and the public have also proposed that the compensation system for abnormal reactions to vaccination should further clarify the scope and standards of compensation and guarantee the compensation costs.

After research, the Constitution and Law Committee of the National People's Congress suggested the following amendments: First, add provisions that compensation for abnormal reactions to vaccination should be timely, convenient and reasonable. Second, add provisions that the scope of compensation should be managed by catalogue and dynamically adjusted according to actual conditions. Third, it is clear that the State Council shall stipulate the scope, standards and procedures of the compensation catalogue, and provinces, autonomous regions and municipalities directly under the Central Government shall formulate specific implementation measures. Fourth, it is clear that the compensation costs required for vaccination of immunization program vaccines shall be arranged by the financial departments of the provincial, autonomous regional and municipal people's governments from the vaccination funds.

Production can only be commissioned with the approval of the Drug Administration

According to the second draft of the Vaccine Management Law, except for the cases otherwise stipulated by the State Council's drug supervision and administration department, the vaccine marketing license holder shall have the ability to produce vaccines and shall not commission production.

The National Medical Products Administration, some members of the Standing Committee, and the public proposed that from the perspective of the development of the vaccine industry, in order to improve the quality and efficiency of vaccine production, regulations should be made on the conditions and approval of vaccine commissioned production.

After research, the Constitution and Law Committee suggested that the above provisions be amended to: "The holder of a vaccine marketing license shall have the ability to produce vaccines; if the production is beyond the scope of vaccine production capacity, it shall be approved by the State Council's drug supervision and administration department and comply with relevant national regulations."

Increase the types of illegal penalties and increase the amount of fines

Some members of the Standing Committee also suggested increasing the punishment for vaccine violations, increasing the amount of fines, increasing the types of penalties, and supplementing the legal responsibilities of some illegal acts.

After research, the Constitution and Law Committee recommends the following amendments:

First, it is clear that if a violation of the provisions of this law constitutes a crime, the criminal liability shall be investigated severely in accordance with the law;

Second, for illegal acts such as the production and sale of fake and inferior vaccines, the fine amount of the relevant units and responsible persons shall be increased. Specifically, the second draft had made it clear that if the production and sale of vaccines are fake, a fine of more than 15 times but less than 30 times the value of the illegal production and sale of vaccines shall be imposed. If the value of the goods is less than 500,000 yuan, a fine of more than 2 million yuan but less than 15 million yuan shall be imposed; if the value of the goods is more than 500,000 yuan but less than 1 million yuan, a fine of more than 5 million yuan but less than 30 million yuan shall be imposed. The third draft raised "more than 15 times but less than 30 times" to "more than 15 times but less than 50 times".

In addition to the case of producing fake drugs, the fine amount for producing inferior drugs has also been increased. The second draft clearly stated that if the vaccines produced and sold are inferior drugs, a fine of more than 10 times but less than 20 times the value of the goods will be imposed, while the third draft has increased it to "more than 10 times but less than 30 times".

Third, administrative detention is added for those responsible for serious violations;

Fourth, corresponding legal liabilities are added for the illegal acts such as the marketing license holders not establishing an electronic vaccine traceability system without approval or in accordance with regulations, collecting and tracking and analyzing suspected abnormal reactions to vaccination, the disease prevention and control institutions and vaccination units not providing traceability information in accordance with regulations, and the guardians not ensuring that children of school age are vaccinated with immunization program vaccines on time.

On April 23, the "Vaccine Management Law (Draft)" and the "Drug Management Law (Revised Draft)" were reviewed for the second time at the 10th meeting of the Standing Committee of the 13th National People's Congress, and both were not passed. At that time, some analysts said that although the overall pattern of the revised draft of the Drug Management Law and the draft of the Vaccine Management Law had been determined after the second review, there was still room for adjustment in some provisions.

Regarding the space that still needs to be adjusted, at that time, Li Zhanshu, Chairman of the Standing Committee of the National People's Congress, said: We must adhere to severe punishment to deal with chaos, write the "four most stringent" into the law, establish a legal system covering the entire process and the entire chain, and ensure that the people's medication is safe, effective and accessible.

It is reported that after the third review, the Vaccine Management Law (Draft) will be further voted on. If the vote is passed, the new Vaccine Management Law will be officially issued.