R & D, production, approval, listing, purchasing & hellip; & hellip; these & ldquo; problem vaccine & rdquo;Where will the public officials involved in the case be dealt with?

The three people of the Food and Drug Administration had been reserved for the vaccine case, and the time returned to the Shandong vaccine case two years ago.

There were three important notices at the time.

  • On April 13, 2016, the Executive Meeting of the State Council heard a report on the investigation and treatment of the illegal vaccine cases in Jinan, Shandong.

According to the identified situation, the meeting decided to account for accountability to the relevant responsible persons (autonomous regions, municipalities), including the State Administration of Food and Drug Administration, the Health and Family Planning Commission and Shandong, and the relevant parties first recounted the 357 public officials., Dowager and other punishments.

  • On August 26, 2016, the website of the Central Commission for Discipline Inspection released & ldquo;

The inspection found that the former State Food and Drug Administration had a serious approval of drugs and light supervision, serious bureaucracy, and severe loss of duty.It has not been noticed for 5 years of illegal business vaccine activities in Jinan, Shandong. There is a major loophole in regulatory supervision, which delays the best time for disposal. After the case of illegal operation of illegal business vaccines in Shandong, the relevant departments organized the incomplete investigation of the case.

The party group of the State Administration of Food and Drug Administration decided to give three relevant responsible persons in the General Administration of Organs who have exceeded the administrative records, remembered, and dismissal.

However, who the three are these three people have no public news.

  • On March 12, 2017, during the two sessions of the country, Cao Jianming, then the Prosecutor of the Supreme People's Procuratorate, made a work report.

According to the report, after Pang Hongwei and others were illegally operated by the vaccine case, the Supreme People's Procuratorate immediately listed and supervised. The procuratorial organs in Shandong, Henan, Hebei and other places strengthened the connection with the regulatory authorities and the public security organs.174 criminal crimes and other duties were investigated and dealt with.

Who will give the vaccine approval & ldquo; turn on the green light & rdquo;

Vaccine takes many links from production to listing.The vaccine sold in China must conduct clinical trials. It can only be obtained after passing the approval of the State Drug Administration.& nbsp;

Tracing back to the source, there have been problems with the vaccine approval session.

On the China Magistrate Document Network, with the keywords of the & ldquo; vaccine & rdquo; and searched the Shandong vaccine case to this day, the judgment of the criminal case showed that there were more than 700 results, of which 216 involved corruption and bribery.The most impressive is Yin Hongzhang, deputy director of the Drug Review Center of the State Food and Drug Administration.

Yin Hongzhang once served as the director of the Biological Products Division of the Pharmaceutical Registration Department of the former State Drug Administration. The main responsibilities include the relevant work of organizing the registration management system and standards of biological products, and supervising the implementation of and undertaking and undertaking the evaluation of the quality management system evaluation of the vaccine supervision.

In September 2010, Yin Hongzhang began as the former deputy director of the Pharmaceutical Review Center of the State Food and Drug Administration of Food and Drug Administration. He was responsible for the work of biological product review, and in charge of the Department of Biological Products and Pharmacy, Research and Evaluation Department, and other departments.

In these two positions, he has repeatedly used his position to help in Zhejiang, Shanghai, Liaoning and other vaccine companies to help and seek benefits in pharmaceutical application, approval and other matters.

There is a detail that explains how he approved the vaccine & ldquo; turned on the green light & rdquo;.

In early 2010, Zhuang Mou, the general manager of Liaoning Chengda Biological Company, provided Yin Hongzhang's son Yin Moumou with 1 million yuan, as the start -up funds for Yin Moumou's futures business.

At that time, Liaoning Chengda Biotechnology Co., Ltd. used the injection method of the applicant of the State Food and Drug Administration with rabies vaccine & ldquo; 2-1-1 & rdquo; but the company's clinical trial plan lacked an experimental data.The opinion of the meeting is to require Liaoning Chengda Company to re -experiment and report for approval.

However, at the Second Review Meeting, Yin Hongzhang suggested to pass the application first. After the product was listed, Liaoning Chengda made an experiment.The company's application was then passed smoothly.

In June last year, the Beijing Higher People's Court announced the criminal ruling of Yin Hongzhang's second instance, determined that Yin was alone or his wife and children received more than 3.56 million yuan in bribe, and maintained the first instance & ldquo;judgment.

Grassroots corruption case

In 216 cases of corruption and bribery, the most problems occurred in the primary vaccine procurement session.

& nbsp;

for example.

Liang Kangbin was originally the director of the Disease Prevention and Control Center of Wuchuan City, Guangdong Province.After the Shandong vaccine case in March 2016, the Guangdong Provincial Center for Disease Control and Prevention suspended the province's vaccine procurement to rectify until it was recovered in July.In order to digest inventory, Yin Mou, the business manager of the western Guangdong region of Guosheng, found Liang Kangbin's hope to resume the use of Guosheng's vaccine products. Liang Kangbin agreed and accepted the cash of Yin's 16,000 yuan and 15,000 yuan.

After the resumption of procurement in 2016, Yang Junwei, a sales representative of the Zhanjiang area of Kexing Company, also found Liang Kangbin. It is recommended that its company newly launched EV71 hand, foot, and mouth disease vaccine, and bribe 5,000 yuan.

In the end, Liang Kangbin was sentenced to two years in prison for bribery, three years in probation, and fined 100,000 yuan.

Other cases, those responsible for purchasing know that the quality of the vaccine is not available, or the sales institution is not qualified, and it is still purchased after bribery.

From July 2011 to March 2016, Liu Jianmin, Dean of the Hospital Hospital of Hai Biwan District, Wuhai City, illegally purchased a second -class vaccine amount from Duan Baoyun, who had no vaccine sales qualification.In April, Liu Jianmin arranged for drug purchaser Gai Xinhua to purchase a second -class vaccine from Duan Baoyun for a total of 1018277.2 yuan.

After the incident, the investigation of the judicial organs found that the relevant departments of the hospital were partially lacking in the inspection certificate of the vaccine involved in the case, the sales voucher, and the cold chain record of vaccine transportation.Whether the vaccination patient is immune cannot be judged.

In the inventory, Yin Mou, the business manager of the western Guangdong region of Guosheng, found Liang Kangbin and hoped to resume the use of Guosheng's vaccine products. Liang Kangbin agreed and accepted the cash of Yin's 16,000 yuan and 15,000 yuan.

After the resumption of procurement in 2016, Yang Junwei, a sales representative of the Zhanjiang area of Kexing Company, also found Liang Kangbin. It is recommended that its company newly launched EV71 hand, foot, and mouth disease vaccine, and bribe 5,000 yuan.

In the end, Liang Kangbin was sentenced to two years in prison for bribery, three years in probation, and fined 100,000 yuan.

Other cases, those responsible for purchasing know that the quality of the vaccine is not available, or the sales institution is not qualified, and it is still purchased after bribery.

From July 2011 to March 2016, Liu Jianmin, Dean of the Hospital Hospital of Hai Biwan District, Wuhai City, illegally purchased a second -class vaccine amount from Duan Baoyun, who had no vaccine sales qualification.In April, Liu Jianmin arranged for drug purchaser Gai Xinhua to purchase a second -class vaccine from Duan Baoyun for a total of 1018277.2 yuan.

After the incident, the investigation of the judicial organs found that the relevant departments of the hospital were partially lacking in the inspection certificate of the vaccine involved in the case, the sales voucher, and the cold chain record of vaccine transportation.Whether the vaccination patient is immune cannot be judged.

The judgment of the first instance believes that Liu Jianmin and Gai Xinhua did not constitute the crime of negligence.

The crime of bribery of the Chinese Medicine Hospital of Hai Biwan District, Wuhai City, was sentenced to 600,000 yuan.

#P#副#E#

How to falsify the vaccine?

Hanmou, Dongchangfu District, Liaocheng, Shandong Province, has no drug production, business license and related qualifications.From January 2015 to October 2015, he produced and sold the immunoglobulin vaccine, frozen -dried people with rabies vaccine, restructuring hepatitis B vaccine, influenza virus cracked vaccine, tetanus immunoglobulin vaccine.

According to his own confession, his fraudulent rabies vaccine, the composition of the pink needle component is the ingredients of coenzyme A and water needles are sodium chloride injection and distilled water. Use a syringe into the bottle, seal it with a sealing machine, and then install the box;The protein vaccine, tetanus vaccine, hepatitis B vaccine, etc. are primary vaccines and physiological saline, and then seated with a syringe into the bottle, and then sealed and packed.

The original vaccine was made in the places such as Hu, Lu, and Jinan Medicine Company; the empty bottle was found in Lu Mou from the Phoenix Industrial Park Clinic.He copied it himself; some medicine boxes were bought from Lu, and some were bought in Zhengzhou, Henan.

The second instance criminal judgment shows that Han has also forged & ldquo; the rabies vaccine (Vero cell) & rdquo; and 20140761-02 and 20140764-02.

In the end, Han was sentenced to two years and nine months in prison for production and sales of fake medicines, and fined 2,000 yuan.From April 1, 2016 to December 31, 2018.

Will it be sentenced to production & ldquo; problem vaccine & rdquo;

Fans have always asked about the king of the government. Will the problem vaccine involved will be sentenced to death?

Let's take a look at the law first.

The Drug Management Law clearly stipulates the supervision of drug production and sales. Unqualified drugs are divided into two types: fake drugs and inferior drugs.

Article 74 of the Drug Management Law stipulates:

Those who produce and sell inferior drugs will confiscate illegal production and sales of drugs and illegal income, and impose fines of more than three times the amount of drug value of illegal production and sales of drugs;

If the circumstances are serious, it is ordered to discontinue production, discontinue business or revocation of drug approval documents, revoke the "Drug Production License", "Drug Business License" or "Medical Institutional Preparation License";

Constitute a crime, be held criminally responsible.

Article 142 of the Criminal Law stipulates:

If the production and sales of bad medicines are seriously harmful to human health, they will be imprisoned for three years and less than ten years, and the sales amount is more than 50 % of the fine;

The consequences are particularly serious. They are sentenced to more than ten years of imprisonment or life imprisonment, and the sales amount is more than 50 % of the amount of more than 50 % fines or confiscated property.

In other words, if & ldquo; serious harm to human health & rdquo; and reached the standard of execution.

Article 2 of the Supreme People's Court's Supreme People's Procuratorate on handling several issues of criminal criminal cases of drug safety stipulates that it is determined to be & ldquo; the situation of serious harm to human health & rdquo; includes:

  • Cause light or serious injuries;

  • What causes mild disability or moderate disability;

  • Discarding organs and tissue injury leads to general dysfunction or severe dysfunction;

  • Other circumstances that cause serious harm to human health.

In addition, the behavior of producing and selling fake drugs may also be suspected of harming public safety by dangerous methods.

Article 114 and 115 of the Criminal Law:

If other hazardous methods endanger public safety and have not yet caused serious consequences, they will be imprisoned for three years and less than ten years.

If a serious injury, death or a major loss of public and private property, it will be imprisoned, life imprisonment or death sentence of more than ten years.

According to the provisions of the Supreme People's Court and the Supreme People's Procuratorate's "Explanation of Several Issues of the Application of Laws in Criminal Cases in Drug Safety":

For the purpose of providing the production and sales of others, in violation of national regulations, non -pharmaceutical raw materials and auxiliary materials that do not meet the requirements of pharmaceutical requirements, and the circumstances are serious, and at the same time, it constitutes the crime of production and sales of pseudo -shoddy products.For crimes such as crime, conviction and punishment shall be determined in accordance with the heavy punishment.