The General Administration of Market Supervision issued a notice late at night to comment on the new situation of the vaccine.

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 The General Administration of Market Supervision issued a notice late at night to comment on the new situation of the vaccine.


At the same time as the draft was published, the website of the State Administration of Market Supervision also published the drafting notes of the Vaccine Administration Law of the Peoples Republic of China (draft for comments). This note gives a detailed interpretation of the background, process and main contents of the drafting of the Vaccine Administration Law of the Peoples Republic of China (draft for comments).

Zheng Zhizhi noticed that the full text of the Vaccine Administration Law of the Peoples Republic of China (draft for comment) contains more than 14,000 words, totaling 11 chapters. Next, follow Jun Zhijun to understand the point of view of the draft law solicitation draft.

background

With regard to the background of the drafting of the Vaccine Administration Law of the Peoples Republic of China (draft for comments), the drafting notes mentioned at the beginning that vaccines are related to peoples life and health, public health and national security. Changchun Changsheng Problem Vaccine Case not only exposes many loopholes such as inadequate supervision, but also reflects the system defects in the production, circulation and use of vaccines.

Drafting notes pointed out that after the case occurred, General Secretary Xi Jinping and Prime Minister Li Keqiang made important instructions and instructions on many occasions, demanding that the long-term mechanism of vaccine supervision be speeded up and laws, regulations and rules be improved.

It is not difficult to see that improving the laws and regulations of vaccines is an urgent problem.

Some people may ask, what were the laws and regulations about vaccine production and supervision in China before?

In an article entitled Legal Research on Vaccine Safety Regulation in China, the legislation and regulatory system of vaccine safety supervision in China are reviewed. There are vaccines-related legislation in the categories of laws, administrative regulations and administrative rules. Specifically, the Drug Administration Law of the Peoples Republic of China, the Implementation Regulations of the Drug Administration Law of the Peoples Republic of China, the Regulations on the Administration of Vaccine Circulation and Vaccination, the Regulations on the Quality Management of Drug Business and the Regulations on the Quality Production and Management of Drugs, etc.

The article also pointed out some defects in Chinas vaccine legislation, such as low level of legislation related to vaccine regulation. In view of this, the article mentions that on June 1, 2005, the State Council promulgated the Regulations on the Administration of Vaccine Circulation and Vaccination. This regulation is another legal basis to regulate the work of vaccine supervision in China besides the Pharmaceutical Administration Law, but the main body of formulation is the Ministry of Health, with a lower level. The article also calls on China to introduce a uniform vaccine safety law as soon as possible.

Specifically in Changchun Changsheng Vaccine Case, in October this year, Changchun Changsheng Vaccine Case made significant progress again. The relevant state departments imposed administrative penalties on it and imposed a fine of 9.1 billion yuan. Zheng Zhizhi (Wechat ID: upolitics) noted that the administrative penalties for Changchun Changsheng are based on laws and regulations such as the Drug Administration Law of the Peoples Republic of China and its implementing regulations, as well as the Standards for the Quality Control of Drug Production, the Measures for the Supervision and Administration of Drug Production and the Measures for the Wholesale Management of Biological Products. As for criminal responsibility, 15 persons involved in Changchun Changsheng Vaccine Case were detained. Whether or not they will be punished and what kind of punishment they will be punished need to be released by relevant departments.

In fact, the punishment basis of Changchun Changsheng case can also be seen that the punishment of enterprises and personnel involved in vaccine cases is scattered in several different laws and regulations.

In this legislation, the above-mentioned drafting instructions also make it clear that the provisions of vaccine development, production, circulation, vaccination, abnormal reaction monitoring, safeguards, supervision and management, legal responsibility, which are scattered in many laws and regulations, will be integrated in a comprehensive chain, and the system will be planned and thought, the legal level will be upgraded, and the law will be strengthened. In order to enhance the pertinence, effectiveness and operability of vaccine legislation, it is necessary to formulate a special vaccine management law.

According to the above drafting instructions, it is not difficult to see that the objective of the Vaccine Management Law of the Peoples Republic of China (draft for comments) is a special vaccine management law.

content

Lets take a look at the specific content of the draft.

The draft contains eleven chapters: general principles, vaccine development and listing licensing, vaccine production and wholesale, post-marketing research and management, vaccine circulation, vaccination, abnormal response monitoring and compensation, safeguards, supervision and management, legal liability and supplementary rules.

As for the key part of the content, the drafting note also mentioned that the key point of the draft is to make specific provisions for the special requirements of vaccine supervision in the light of the characteristics of vaccine development, production, circulation and vaccination.

Vaccine production

With regard to vaccine production, Article 24 of the Draft Request for Opinions stipulates that vaccine licensees and vaccine manufacturers shall establish a complete quality management system for vaccine production, strictly implement the quality management standards for drug production, continuously strengthen the management of deviations and changes, record production and inspection data in real time, and ensure production. The process is continuous compliance, and the relevant information and data are true, complete and traceable.

In fact, knowing the whole development of Changchun Changsheng vaccine case, we know that the problem of vaccine lies in the production and wholesale link. The facts of illegal production of rabies vaccine include mixing raw liquor of different batches, re-fabricating production batch number of raw liquor after blending batch, using expired raw liquor to produce some products involved in the case, and cheating the wholesale certificate of biological products by submitting false information.

Vaccine circulation

Zheng Zhijun noticed that the chapter of vaccine circulation in the Draft for Comments stipulated the bidding, procurement, supply and distribution of vaccines, storage and transportation regulations, and destruction of vaccines.

It is worth mentioning that in 2016, the Shandong illegal vaccine case caused peoples reflection and concern about the storage and transportation of vaccines.

Article 40 of the Draft Request for Opinions states that disease prevention and control agencies, vaccination units, license holders of vaccines on the market, and enterprises entrusted with the distribution of vaccines shall abide by the regulations for the storage and transportation of vaccines to ensure the quality of vaccines. The whole process of vaccine storage and transportation should be in a prescribed temperature environment. Cold chain storage should meet the requirements, and real-time monitoring and recording of temperature.

Supervision

After the Changchun Changsheng vaccine incident detonated public opinion, vaccine regulation is also a common concern. Zheng Zhijun noted that Articles 69 to 82 of the Draft Request for Opinions regulate supervision and management in many ways.

The seventy-first section refers to the supervision and inspection by the pharmaceutical supervision department. It is pointed out that the drug regulatory department under the State Council is responsible for the supervision and inspection of vaccine development and licensee of overseas vaccine market, and the provincial drug regulatory department is responsible for the supervision and inspection of vaccine production. If necessary, extended inspection may be carried out for other relevant units providing products or services for vaccine development, production, distribution, storage and other activities. No unit or individual may refuse.

The seventy-ninth section refers to the specific responsibilities of local governments. It was pointed out that the higher peoples governments, their drug regulatory departments and health administrative departments could supervise and inspect the vaccine supervision work of the lower peoples governments and their relevant departments. If it is found that it fails to perform its duties or fails to perform its duties correctly, it may take such measures as responsibility interview, ordering correction and dealing with it according to law.

Severely punish illegal activities

The drafting notes pointed out that the draft for soliciting contributions severely punished the illegal activities. This is reflected in Article 84, Article 86, Article 88, Article 89, Article 96 and Article 97 of the Draft for Solicitation of Opinions.

Specific contents:

Knowing that the vaccine still has quality problems still being sold, the recipient can claim punitive damages.

If the relevant offenses constitute a crime, they shall be investigated for criminal responsibility according to law. In terms of administrative responsibility, for violating the provisions of vaccine administration, the punishment range is generally heavier within the punishment range of the Drug Administration Law.

Summarize the problems exposed in vaccine cases in recent years, and severely punish subjective deliberate violations such as data fraud.

We should strengthen the accountability of regulatory authorities and local governments. If the supervisory department fails to perform its duties or improperly performs its duties and causes serious consequences, the local government organization and leadership fails to cause serious damage, the responsibility shall be seriously investigated in accordance with the law.

Those who participate in, shelter or connive in the illegal and criminal acts of vaccines, commit fraud, conceal facts, interfere with and obstruct the investigation of liability, or help forge, conceal or destroy evidence, shall be investigated for their responsibilities according to law.

It is noteworthy that Article 89 of the Draft Request for Opinions stipulates that if the holder of a vaccine listing license has one of the following circumstances, he shall confiscate his illegal income, order the suspension of production and business, revoke the listing license documents, and impose a fine of more than five times and less than ten times the value of the goods:

(1) submit false clinical trials or information on the application for listing;

(two) fabricate the production verification record and change the batch number of the product;

(3) Submitting false declarations for wholesale distribution or obtaining certificates for wholesale distribution by other deceptive means;

(4) failing to take recall measures when quality problems or other potential safety hazards are found in the vaccines sold on the market;

(five) other serious illegal acts with subjective intent.

In fact, in view of the above situation, if compared with articles 73 and 74 of the Drug Administration Law of the Peoples Republic of China, the provisions of the draft for soliciting opinions are undoubtedly more stringent, meticulous and heavier punishment, which is also consistent with the statement in the drafting notes that severely punish illegal acts.