China's special law on vaccine management was approved.
In the afternoon of June 29, the 11th session of the 13th National People's Congress voted to pass the Law of the People's Republic of China. Then, the General Committee of the Standing Committee of the National People's Congress held a press conference in the People's Great Hall.
Jiao Hong, head of the State Drug Administration, said at the meeting that the law clearly stated that the vaccine should be conducted with the strictest monitoring and that specific rules and regulations were put forward for the whole process of development, production, circulation and vaccination of vaccines.
Among them, for surveillance, Yuan Jie, head of the administrative law office of the Legislative Committee of the National People's Congress Permanent Committee, told the Daily Economic News reporter that criminal liability should be exercised for crimes constituting crime. In the previous law there was no legal responsibility. The first one has appeared. This vaccine management law is listed in the first article, which clearly reflects the strictest principles.
Jiao Hong also stressed that the law on vaccine management provided the production and sale of counterfeit vaccines, the application of vaccine registration to provide false information and infringements of relevant quality management and other illegal acts, a higher penalty than the general drugs.
Why is the law? Vaccines are extremely important and specific
In the past, China has introduced the Act on Drug Administration, Infectious Disease Prevention and Control Law, and the provisions on vaccine circulation and vaccination management. In fact, the vaccine management system has been established. Why do you need to develop a vaccine management team?
Yuan Jie said in this regard that in recent years there have been some problems in the vaccine. Particularly after the Changchun Changsheng Vaccine Incident, the party's central committee and the government have attached great importance to this issue and have had several meetings to study. One of the important requirements is that it is necessary to further improve the management system for vaccines.
At the same time, the extreme importance of the vaccine and the specificity also show the need for special legislation.
Yuan Jie said that due to the extreme importance of the vaccine. The law clearly states in the general regulations that "the state follows the strategic and public welfare of the vaccine products". It is related to people's lives and health, to public health safety, to the future quality of life of our country and the nation and to our country's health policy. A very important link in preventive work. Due to the extreme importance of vaccine activities and vaccine work, its regulatory construction is even more necessary.
"At the same time, since the vaccine has some special characteristics in management, and the quality requirements are relatively high, special legislation also helps to increase the efficiency and feasibility of legality." Yuan Jie said.
Jiao Hong said the vaccine means public safety and national security, so it is really special compared to general drugs. At the same time, vaccines are a very effective public health service to prevent and control infectious diseases. It is a preventative product used by healthy people. A large part of this healthy population is especially infants and toddlers. This feature is very prominent.
In addition, Jiao Hong also pointed out that vaccine products such as biological products have complexities in the production process. This means that vaccine production must be safe, efficient and controllable, and there will be more requirements. To make the vaccine safe, effective and available, the vaccine has been specifically issued.
Based on legal standards, Yuan Jie pointed out that the collection and integration of the rules is spread in relevant laws and administrative provisions in a single law helping to empower the system's overall design, marking the authority of the law and at the same time facilitating each Om the main operation.
How to monitor? Full process traceability and controllable
Previously, Changchun Changsheng problem vaccine case revealed many loopholes, such as insufficient monitoring and monitoring. How strengthened monitoring has also become everything's attention to all parties.
Yuan Lin, head of the pharmaceutical company, said that the vaccine management legislation not only clarifies the quality and safety responsibilities of the company to the government but also to various departments and further clarifies the regulatory measures and responsibilities of the whole process and the entire life cycle of the vaccine. The basic aim is to fully strengthen vaccine management and ensure the quality of vaccines.
During the implementation of the electronic traceability system, the entire process can be tracked and verified. At the same time, the production company must establish a complete production quality system and use information and electronic means to record data for production and inspection. Responsible for the main responsibility, responsible for the production process, in accordance with relevant requirements and standards.
In terms of batch release, the vaccine management law explicitly requires that all vaccines be reviewed and approved in batches to ensure quality and safety, including production and inspection data, and pre-listing sampling tests. "When the batch is issued and the quality risks and problems are discovered during the implementation process, effective action should be taken immediately," said Yuan Lin.
Yuan Lin emphasized that there is another important measure that requires marketing authorization vaccine holders to independently establish and improve their lifecycle management systems. "It is not finished production, the batch is issued and the listing is complete. It is required that quality assurance analysis of the vaccines be produced by the company after listing and after approval. The key is to continue to improve the quality control of the vaccines through research. Yuan Lin said.
In addition, the vaccine management law further emphasizes and clarifies the enhancement of information disclosure and suggests that the strengthening of the pharmaceutical regulatory capacity be built up.
At present, the number of drug inspectors in China is still relatively small. Yuan Lin said there are thousands of pharmaceutical companies in China and more than 100,000 approval documents, but there are only more than 800 state-level drug inspectors. Most are part-time inspectors. "Our statistics show that there are fewer than 100 national inspectors who can specifically inspect vaccines, and the number is relatively small compared to industry."
How do you owe it? Criminal punishment for constituting a crime
At the same time, the reporter "Daily Economic News" noted that the vaccine management law clearly stated that it is necessary to establish a professional and professional inspection team at central and regional levels, strengthen the construction of inspectors and build capacity, and further Strengthen the monitoring and control of vaccines and the monitoring of the entire life cycle of to ensure the quality and safety of vaccines.
In the case of punishment, the first clause in Chapter 10 states "Legal Liability" that violation of the provisions of this Act shall be punished in accordance with the law.
Yuan Jie said that this time it is very clear that if a crime is committed in violation of the provisions of this law, criminal liability shall be exercised by law. In the law, it is generally said that the emphasis is not entirely in criminal law, but it shows that an attitude is a violation of this law constitutes a crime, and criminal law should be heavier. The next step in the Criminal Code is to make appropriate adjustments according to the content of the drug administration law, but in general it is punishable according to the statutory penalty.
In terms of administrative sanctions, Yuan Jie said that if it is the production and sale of false vaccines, confiscation of illegal revenue, confiscation of illegal production and sale of vaccines, confiscation of illegal raw materials for the production and sale of vaccines, equipment and other items, ordered to cease production and rectification, withdrawal of drug registration certificate, Until other licenses as production licenses are revoked. Of course, the production and sale of false vaccines is the heaviest and the value of the fine is 15 times or more and 50 times or less.
"This is not only good, there are so many funds, but also punished people. For these illegal production units, these, if there are legal representatives, chief persons, directors, key positions, there are other responsible staff, confiscation of their relevant income, and punishment 1 to 10 times the proceeds, both life imprisonment and even detention. "