250,000 problematic vaccines are exposed. Is it enough for immortality to apologize？
Recently, National Medical Products Administration reported that Changchun Changsheng Biotechnology Co., Ltd. (hereinafter referred to as "Changchun Changsheng") illegally produced rabies vaccine, and there were some behaviors such as record fraud. The death rate of rabies is almost 100%, and the falsification of vaccine production records has aroused widespread concern in society.
Notice of National Medical Products Administration on the illegal production of freeze-dried rabies vaccine for human use by Changchun Changsheng Biotechnology Co., Ltd. (No.60, 2018)
Published on July 15, 2018
According to the clues, National Medical Products Administration organized a flight inspection of Changchun Changsheng Biotechnology Co., Ltd., and found that there were serious violations of the good manufacturing practice in the production of freeze-dried rabies vaccine for human use.
National Medical Products Administration has asked Jilin Food and Drug Administration to take back its GMP Certificate (certificate number: JL20180024), ordered it to stop the production of rabies vaccine, instructed the enterprise to strictly implement the main responsibility, comprehensively investigate potential risks, and take the initiative to take control measures to ensure the safety of public medication. The investigation team of Jilin Food and Drug Administration has been stationed in the enterprise to investigate the relevant violations of laws and regulations. National Medical Products Administration sent a special inspection team to Jilin to supervise the investigation and disposal.
All batches of products involved in this flight inspection have not yet left the factory and gone on sale, and all products have been effectively controlled.
National Medical Products Administration always puts the safety of people’s medication in the first place, resolutely implements the "four strictest" requirements of the Supreme Leader General Secretary, and will not tolerate the problems found in violation of laws and regulations, and resolutely investigate and deal with them severely according to the law. Anyone suspected of constituting a crime will be transferred to the public security organs for severe punishment.
This is for your information.
the State Drug Administration (SDA)
July 15, 2018
On July 17, Changchun Changsheng issued a statement saying that it had stopped the production of rabies vaccine as required and "deeply apologized". In this regard, many people said that such a big thing should not just be "apologized" but should be "punished".So, should Changchun Changsheng be "punished"? In this regard, the reporter interviewed relevant experts and scholars.
Is the vaccine with false production records a fake drug?
The reporter learned that Article 101 of the Drug Administration Law clearly stipulates that vaccines belong to drugs: drugs refer to substances that are used to prevent, treat and diagnose human diseases, purposefully regulate human physiological functions, and specify indications or functional indications, usage and dosage, including Chinese herbal medicines, Chinese herbal pieces, Chinese patent medicines, chemical raw materials and their preparations, antibiotics, biochemical drugs, radioactive drugs, serum, vaccines, blood products and diagnostic drugs. Ruan Qilin, a professor at China University of Political Science and Law and vice president of china law society Criminal Law Research Association, pointed out that National Medical Products Administration imposed administrative punishment on the rabies vaccine produced by Changchun Changsheng for violating the good manufacturing practice, which also confirmed that China recognized rabies vaccine as a drug.
So, is the vaccine that produces false records a fake drug? Article 48 of the Drug Administration Law stipulates that drugs containing ingredients that are inconsistent with those stipulated in the national drug standards, and those that pass off non-drugs as drugs or pass off other drugs as such drugs are counterfeit drugs. Ruan Qilin said that the "ingredient mismatch" referred to by counterfeit drugs refers to the inconsistency of ingredient types, rather than the substandard content of ingredients.
The reporter learned that the production record is the basic label and file of the product, which not only records the production process of the enterprise, but also records the basic information of the product such as raw materials, preparation, composition, performance, production date and sales destination. "The specific situation of production record fraud is related to the identification of whether the rabies vaccine involved is a counterfeit drug." Liu Junhai, a professor at Renmin University of China and vice president of China Consumers Association, said that the details of Changchun Changsheng’s fraudulent vaccine production records need further investigation.
"If the rabies vaccine involved in the case is fraudulent in the type of active ingredients, it should be considered as a counterfeit drug."Ruan Qilin said that if it is suspected of changing the expiration date or production batch number and reducing the content of active ingredients, it should be identified as inferior drugs according to Article 49 of the Drug Administration Law.
Can you be exempted from legal responsibility without causing adverse reactions?
Although National Medical Products Administration has imposed administrative punishment on Changchun Changsheng for falsifying production records, the company’s claim that all rabies vaccines of the company "have not had any adverse reactions due to product quality problems" cannot rule out the possibility that the company may constitute a criminal offence.
Liu Junhai introduced that the production and sale of counterfeit drugs is enough to seriously endanger human health, which constitutes the crime of producing and selling counterfeit drugs, which is a dangerous crime in criminal form. Article 3 of the Interpretation of the Supreme People’s Court and the Supreme People’s Procuratorate on Several Issues Concerning the Specific Application of Laws in Handling Criminal Cases of Producing and Selling Fake and Inferior Commodities (hereinafter referred to as the Interpretation) stipulates that if the counterfeit drugs produced and sold are identified by the drug inspection institutions set up or determined by the drug supervision and administration departments at or above the provincial level, they shall be deemed as "enough to seriously endanger human health" as stipulated in Article 141 of the Criminal Law: containing excessive toxic and harmful substances; Does not contain the marked effective ingredients, which may delay the diagnosis and treatment; The indicated indications or functional indications are beyond the prescribed scope, which may cause delay in diagnosis and treatment; Lacking the marked effective ingredients necessary for first aid.
"Once the vaccine involved does not contain the active ingredients indicated in the production records, the potential vaccinators will be in danger." Qi Qilin said.
The reporter learned that the rabies vaccine involved in Changchun Changsheng was not listed for sale. If the production record is only fraudulent in composition content or the expiration date is changed, then the rabies vaccine belongs to "inferior medicine" according to relevant regulations.
Ruan Qilin told reporters that the crime of producing and selling inferior drugs in criminal law belongs to the real crime, and it can only constitute a crime if it has caused serious harm to human health. "If the production and sale of inferior drugs do not cause serious harm to human health, it does not constitute the crime of producing and selling inferior drugs. However, if the sales amount is more than 50,000 yuan, it should constitute the crime of producing and selling fake and inferior products according to the provisions of Article 149 of the Criminal Law." Ruan Qilin said that although Changchun Changsheng has no sales behavior, according to Article 2 of the Interpretation, if the fake and inferior products have not been sold and the value of the goods reaches more than three times the sales amount stipulated in the Criminal Law, they will be convicted and punished for the crime of producing and selling fake and inferior products (attempted). That is to say, in this case, as long as the value of the rabies vaccine involved reaches 150,000 yuan, it can be concluded that Changchun Changsheng constitutes the crime of producing fake and inferior products.
If Changchun Changsheng’s production record of rabies vaccine involved in the case is not related to the fraud of items listed in Articles 48 and 49 of the Drug Administration Law, but other general production records, Ruan Qilin said that in this case, Changchun Changsheng will not constitute a crime, but the production record fraud violates the good manufacturing practice, and administrative responsibility is inevitable.
How to standardize the honest production of pharmaceutical companies?
It is understood that Changchun Changsheng has not been named for the first time. On November 3, 2017, the former State Food and Drug Administration detected that the titer index of DTP vaccine with batch number 201605014-01 produced by Changchun Changsheng did not meet the standard.
"Why do pharmaceutical companies refuse to change their education? The key is that the illegal cost of pharmaceutical companies is too low, and they are fined, changed their drug names and continued to operate. " Liu Junhai said that in order to achieve the effect of dealing with one piece of education, we must grasp the typical cases and deal with them strictly according to law. Once Changchun Changsheng constitutes a criminal offence, it should not only bear the corresponding criminal responsibility, but also strictly implement the industry ban system.
The reporter learned that Article 75 of the Drug Administration Law clearly stipulates that the directly responsible person in charge and other directly responsible personnel of enterprises or other units engaged in the production and sale of counterfeit drugs and the production and sale of inferior drugs shall not engage in drug production and business activities within ten years. "In addition to strictly implementing the supervision of pharmaceutical companies, relevant government departments should actively guide pharmaceutical companies to establish the concept of safety first and honest management, and enhance the credibility and core competitiveness of vaccine manufacturers." Liu Junhai said.
There are still four questions to be solved behind the immortal creatures.
Ask
Why did it take nearly 9 months to announce the punishment decision?
On July 15th, National Medical Products Administration notified Changchun Changsheng Rabies Vaccine, a subsidiary of Changsheng Bio, of the problem of falsification of production records, and the lid of the problematic vaccine was uncovered due to an insider’s report. Jilin Food and Drug Administration has withdrawn its GMP Certificate and stopped the production of rabies vaccine. The investigation is still going on. As of the last trading day, Changsheng Bio shares have been down for five consecutive days. Meanwhile, another cover was opened. On July 19, Changsheng Bio issued an announcement and received a penalty decision on the old case of DTP vaccine.
On July 20th, Jilin Food and Drug Administration made this decision public in official website, and the date of signature was July 18th.
It has been nearly nine months since this decision was made. It was only three days after the incident of rabies vaccine.
What is the consideration for this time arrangement? Voice of China reporter called several people in charge of Jilin Food and Drug Administration several times last night, but no one answered or hung up the reporter’s call.
Second question
Where is the problem vaccine?
The penalty decision stated that 186 remaining vaccines in stock were confiscated. However, beyond the inventory, 252,600 problematic vaccines have been sold to Shandong Provincial Center for Disease Control and Prevention. Where are these vaccines? Among the public reports, a report published in the Beijing News on November 5 last year mentioned — — The report quoted the person in charge of the marketing department of Shandong Food and Drug Administration as saying: 1. Relevant departments are carrying out the recall work; 2. The problem drugs have all been sealed. 3. There is no problem with the safety of this batch of drugs, but the titer is not up to standard. At present, no cases of problems with the vaccination of this batch of vaccines have been found.
Regarding the statement of safety, experts from China Center for Disease Control and Prevention confirmed that it may affect the immune protection effect, but the risk of vaccination safety has not increased.
But how many vaccines have entered the market? Is it all sealed up, or is it true that some children have been injected with the problem vaccine, and how many? Are there any children who are sick and have their health damaged because of the problem vaccine? How do parents judge whether their children are vaccinated with a problem vaccine and whether there are any relief channels?
Voice of China reporter tried to ask the relevant person in charge of Shandong Food and Drug Administration last night, but did not get a reply. On the other hand, the State Administration of Markets said that it would consider responding to relevant issues on Monday.
Three questions
Are immortals hiding something?
According to the Measures for the Administration of Information Disclosure of Listed Companies, when a company is suspected of violating laws and regulations and is investigated by the competent authorities, and investors have not yet learned about it, the listed company shall immediately disclose the cause, current status and possible impact of the incident. However, it was not until three days ago that Changsheng Bio broke the silence, disclosed the penalties and admitted that the DTP workshop had stopped production.
According to another report in shanghai securities news, in the 2015 annual report of Changsheng Bio, the number of DTP batches issued by the company was about 5.62 million, ranking first among the six vaccine products sold by the company. In the annual reports of the company in 2016 and 2017, it was still stated that the products sold by Changchun Changsheng included DTP vaccine, but the batch number of vaccines was not disclosed. Another change is that DTP has also disappeared in the company’s product picture list for sale in the past two years.
When did the company stop the production of DTP vaccine? The announcement didn’t say.
Last night, no one answered the external calls of Changsheng Bio.
On July 20, Shenzhen Stock Exchange issued a letter of concern, requesting Changsheng Bio to make supplementary explanations on the proportion of products in the company’s revenue, the specific impact on the company and the countermeasures to be taken by the company. In addition, the company is required to explain whether there is any untimely information disclosure and other matters such as the company’s production and operation.
At the regular press conference of the CSRC on the same day, Gao Li, spokesperson of the CSRC, also talked about the information disclosure of listed companies. She said that with the continuous strengthening of supervision and law enforcement, the disclosure quality of financial information of listed companies has been greatly improved in recent years, but the disclosure quality of other major events still needs to be improved. All major events that may have a greater impact on the stock trading price of listed companies should be disclosed in time according to law, fully explaining the cause, current status and possible impact of the event. In the next step, the CSRC will do a good job in related work and severely crack down on various types of illegal information disclosure.
Gao Li: "The information disclosure obligations stipulated in the Securities Law and the Measures for the Administration of Information Disclosure of Listed Companies are diverse and rich in content. Any major event that may have a great impact on the stock trading price of listed companies should be disclosed in time according to law, fully explaining the cause, current status and possible impact of the event."
Four questions
Is the punishment of Jilin Food and Drug Administration too light?
The penalty decision shows that for the DTP vaccine involved, a total of 858,800 yuan of illegal income was confiscated, and a fine of 2.584 million yuan was imposed for three times the value of illegally produced drugs.
A total of 250,000 problematic vaccines were fined 3,442,900 yuan, and there were many doubts.
However, the punishment decision also clarifies the punishment basis — — According to the Drug Administration Law, those who produce and sell inferior drugs shall have their illegally produced and sold drugs and illegal income confiscated, and shall be fined for more than one time and less than three times the value of illegally produced and sold drugs; Inferior drugs are mainly used by pregnant women, infants and children, and will be severely punished within the scope of punishment.
On the other hand, the Drug Administration Law also stipulates that if the circumstances of producing and selling inferior drugs are serious, it shall be ordered to stop production, suspend business for rectification or revoke the drug approval documents and relevant licenses; If a crime is constituted, criminal responsibility shall be investigated according to law.
Many legal professionals told reporters that within the existing legal framework, triple punishment is indeed a "heavier punishment"; As for whether the circumstances are "serious", it is difficult to determine that there is no evidence to prove that the DTP vaccine involved has had a great impact. However, they also said that China’s current handling of similar violations of laws and regulations is light and the warning is not enough.
A senior lawyer suggested that similar acts should be capped with ten times punishment, but he also admitted that the current Drug Administration Law was revised only 15 years ago, and it is unlikely to be revised again in a short time.