China.com April 28 (Reporter Zhang Yanling) Normal saline is used as HPV nine-valent vaccine, mixing Chinese medicine and Western medicine into powder and selling it as pure Chinese medicine. Sales of Chinese herbal medicine should be informed of the decoction and precautions. Disinfection products indicate treatment functions to mislead consumers to purchase, which constitutes fraud... The Supreme People's Court days ago released 10 typical criminal, administrative and civil cases involving drug safety, and reminded the public when purchasing medicines, and went to a regular pharmacy to avoid being deceived.
Drug safety concerns the lives and health of the people, the overall social security and stability, and is an important issue for people's livelihood. People's courts at all levels across the country attach great importance to drug safety trials, hear criminal, administrative and civil cases involving drugs in accordance with the law, severely punish crimes endangering drug safety in accordance with the law, protect the legitimate rights and interests of consumers, supervise and support drug safety administrative management and law enforcement, and promote the construction of a standardized, orderly, safe and secure drug market environment.
From 2013 to 2021, courts across the country concluded more than 27,000 first-instance criminal cases of production, sales, and provision of counterfeit drugs, and crimes of obstructing drug management, with more than 36,000 sentences. A large number of drug safety crimes were also convicted and punished for related crimes such as the crime of producing and selling counterfeit and inferior products, effectively deterring and cracking down on illegal and criminals endangering drug safety. At the same time, a large number of administrative and civil cases involving counterfeit drugs, inferior drugs, and other inferior drugs were concluded to effectively maintain the order of drug business and management, and effectively protect the legitimate rights and interests of the people.
Since the 18th National Congress of the Communist Party of China, the Supreme People's Court has independently or in conjunction with relevant departments to formulate and issue judicial interpretations and normative documents such as "Regulations on Several Issues Concerning the Application of Laws in the Trial of Food and Drug Disputes", "Measures for the Connection of Food and Drug Administrative Law Enforcement and Criminal Justice", and "Interpretation on Several Issues Concerning the Application of Laws in the Handling of Criminal Cases End of Drug Safety", and has continuously adapted to the new needs of legal guarantee for drug safety in the new era and played an important role in ensuring the safety of people's medication. At the same time, the Supreme People's Court actively worked with relevant departments to promote the establishment and improvement of the working mechanism for the connection between drug administrative law enforcement and judicial affairs, participate in the comprehensive social governance of drug safety, form a working force for legal guarantees for drug safety, and jointly promote the strengthening of the entire process of drug safety supervision.
Next step, the Supreme People's Court will conduct in-depth research on new situations and new problems faced in judicial practice of punishing crimes endangering drug safety, guide local courts at all levels to effectively play their judicial functions, severely punish crimes endangering drug safety in accordance with the law, hear administrative and civil cases in the field of drug safety in accordance with the law, supervise and support drug authorities to strengthen supervision in accordance with the law, and effectively protect the lives and health of the people.
Attachment: Drug safety 10 major typical cases
Case 1: Niu Moumou and others produce and sell fake drugs
- Use syringe to fill normal saline with a syringe to fake nine-valent human papillomavirus vaccine sales
In the first half of 2018, the defendant Niu Moumou learned that the nine-valent human papillomavirus vaccine (hereinafter referred to as the nine-valent vaccine) was sold well, so he looked for packaging, consumables and related processes similar to the genuine products and prepared to produce counterfeit products. From July to October 2018, Niu Moumou purchased more than 40,000 sets of syringes, push rods, pistols, needles and other items through others, and customized more than 41,000 sets of packaging boxes, instructions, labels and other items needed for counterfeit nine-valent vaccines. During this period, Niu Moumou and his co-defendant Zhang Moumou produced counterfeit nine-valent vaccines by filling normal saline into the syringe in Dan County, Shandong Province. They then produced a total of 23,000 counterfeit nine-valent vaccines through trademark pasting and tray plastic sealing. Niu Moumou and Zhang Moumou sold 9,004 of the above counterfeit nine-valent vaccines through multiple medical beauty WeChat groups and other channels, with a sales amount of more than 1.2 million yuan. After inspection by Suzhou Drug Inspection and Testing Research Center, the liquid components contained in the counterfeit nine-valent vaccine sampled and sent for testing are basically the same as those of normal saline.
After trial, the court held that the defendants Niu Moumou and Zhang Moumou jointly produced and sold fake vaccines, which constituted the crime of producing and selling fake drugs. Niu Moumou and Zhang Moumou's production and sales amount reached more than 1.2 million yuan, which is "other particularly serious circumstances." Fake drugs produced and sold are injectable vaccines and should be punished severely as appropriate.In the joint crime, Niu Moumou is the main culprit and Zhang Moumou is an accomplice, so Zhang Moumou is given a lighter punishment. Both defendants pleaded guilty and accepted punishment. Based on this, the defendant Niu Moumou was sentenced to fifteen years in prison and fined RMB 1.5 million for the crime of producing and selling fake drugs; the defendant Zhang Moumou was sentenced to thirteen years in prison and fined RMB 1 million.
vaccine is a preventive biological product used for human immunization to prevent and control the occurrence and epidemic of diseases. It is a drug that is subject to special management by the state. Vaccines include immunization program vaccines and non-immunization program vaccines. The human papillomavirus vaccine is a non-immunization program vaccine and is voluntarily vaccinated by residents. There are currently three types on the market, including bivalent, tetravalent and ninevalent. Among them, the ninevalent vaccine is the vaccine with the largest number of preventable human papillomavirus , and the best vaccination age is 16 to 26 years old. In this case, the two defendants produced and sold counterfeit nine-valent human papillomavirus vaccine by filling syringes with normal saline. It belongs to the " of the Drug Administration Law of the People's Republic of China" that "using non-drugs as drugs" stipulated in the "" drug administration law of the People's Republic of China, and should be deemed to be a fake drug. Such crimes not only prevent consumers from paying high prices but failing to obtain corresponding immunization effects, but some consumers also missed the best vaccination age and opportunity, and the social harm was serious and should be severely punished according to law. For consumers, they should go to regular medical institutions to get vaccinated to ensure the safety and effectiveness of vaccination.
Case 2: Gao Mou and others produce and sell fake drugs
——The "black workshop" mixes Chinese medicine and Western medicine into powder to pretend to be pure Chinese medicine sales
From 2018 to September 2020, in order to obtain illegal benefits, the defendant Gao Mou did not obtain the drug production license and drug business license without obtaining the drug production license and drug business license Under the circumstances of the evidence, in the residence of Nanhengli, Puning City, Guangdong Province, the Chinese medicinal materials Polygonum multiflorum , licorice , fennel and Western medicine bromine, oleracea dyketone tablets, compound licorice tablets, calcium hydrogen phosphate chewable tablets, prednisone acetate , chlorphenamine maleate , etc. were mixed into powder in a certain proportion, and the defendant Li was hired to subpackage and package the powder into a finished product. Gao used the fake name of "Special Cough and Asthma" and fabricated the powder as a "secret recipe" and "pure Chinese medicine ingredients". It mainly treats cough, tuberculosis , asthma , bronchitis , and bronchitis , and sold it to the public at a price of 25 to 40 yuan per pack, with a total sales amount of more than 1.86 million yuan. Li also purchased the above-mentioned fake medicine from Gao and sold it to the defendant Huang and others at a high price. The Huaian Municipal Market Supervision and Administration Bureau of Jiangsu Province has determined that the drugs involved are fake drugs.
After trial, the court held that the defendant Gao and others' behavior of producing and selling fake drugs constituted the crime of producing and selling fake drugs. Gao's production and sales amount reached 1.86 million yuan, which is "other particularly serious circumstances." Based on this, the defendant Gao was sentenced to ten years and nine months in prison for the crime of producing and selling fake drugs and fined RMB 3.72 million. The other defendants were sentenced to one year, six months to ten years and three months in prison and fined.
In recent years, some criminals have taken advantage of the public's trust in traditional Chinese medicine and privately prepared traditional Chinese medicine under the guise of "secret recipes passed down from ancestors" and "pure Chinese medicine ingredients". Some have also mixed Western medicine ingredients into traditional Chinese medicine and pretended to be pure Chinese medicine to sell it to the outside world, which not only affects the treatment effect of the disease, but also brings major hidden dangers to the safety of the drug and human health. The "Pharmaceutical Administration Law of the People's Republic of China" stipulates that "non-drugs are used as drugs or other drugs are used as such drugs" are fake drugs. In this case, the defendant Gao incorporated a variety of Western medicines into Chinese medicine and pretended to be pure Chinese medicine to sell them. This was a case of "using other medicines as such medicines". It was identified as a fake medicine by the municipal drug supervision and administration department, so it was convicted and punished for the crime of producing and selling fake medicines. This case also reminds consumers not to believe in false propaganda such as "ancestral secret recipes". They should purchase drugs through formal channels to ensure the safety of drug use.
Case 3: A case of a Beijing tumor drug company selling fake drugs
——The drug company purchases and sells fake drugs
In August 2018, the defendant's unit Beijing tumor drug company purchased the drug "Ridaxian (thymus method for injection)" at a low price through informal channels. As the directly responsible supervisors of the company, the defendants Lu, Zhao and Zhang, as the direct responsible persons of the company's sales, knew that the above-mentioned drugs had no legal procedures and were purchased from illegal channels and the purchase price was lower than the normal price, they still sold the above-mentioned "Rida Xian (thymus for injection)" to the victim Wu in Dongcheng District, Beijing twice on September 7 and 11, 2018, with a total sales amount of 9,600 yuan. After China Food and Drug Inspection Institute inspection, the "Ridaxian (thymus for injection)" involved in the case did not meet the requirements according to the imported drug registration standards, which is inconsistent with the national drug standard . The Beijing Dongcheng District Market Supervision and Administration Bureau confirmed that the drug involved is a fake drug.
After trial, the court held that the defendant's act of selling fake drugs by a Beijing tumor drug company constituted the crime of selling fake drugs. The defendants Lu, Zhao and Zhang are the directly responsible supervisors for the company's sales of counterfeit drugs, and the defendants Wu and Wang are other directly responsible persons for the company's sales of counterfeit drugs, and they also constitute the crime of selling counterfeit drugs. Because the drug involved in the case is an injection drug, it should be punished severely as appropriate. Given that Lu and Zhao surrendered themselves and that each defendant voluntarily pleaded guilty and repented, he may be given a lighter punishment according to law. Based on this, the defendant's unit Beijing Cancer Drug Co., Ltd. was sentenced to a fine of RMB 50,000 for the crime of selling fake drugs, and Lu and other defendants were sentenced to nine months and fifteen days in prison and a fine of RMB 10,000.
This case is a typical case of a formal pharmaceutical company with business qualifications selling fake drugs. In order to strengthen drug management and ensure the quality of drugs, the "Drug Administration Law of the People's Republic of China" implements a strict licensing system for drug production and operation, and requires that drug business enterprises should establish and implement a purchase inspection and acceptance system when purchasing drugs, verify the drug qualification certificate and other marks. Those who do not meet the requirements shall not be purchased and sold. In practice, some drug operators purchase drugs from individuals and units without production and business licenses, and fail to comply with the purchase inspection and acceptance system, giving upstream criminals who produce and sell fake drugs an opportunity to take advantage of it. In order to reduce costs, the defendant Lu and others violated the relevant provisions of the Drug Administration Law of the People's Republic of China and purchased drugs without legal procedures at low prices through illegal channels. After inspection, they were fake drugs and had the subjective intention of selling fake drugs. The drug involved in this case, Ridaxian (thymus for injection), is an injection drug. The sale of such fake drugs seriously infringes on the safety of the public's medication and life and should be punished according to law.
Case 4: A pharmaceutical company sued the former Food and Drug Administration of Guangdong Province, the former State Food and Drug Administration Administrative penalties and administrative reconsideration
——Supervising and supporting administrative agencies to investigate and punish production and sales of inferior drugs in accordance with the law
Guangdong Province Zhongshan City (hereinafter referred to as Zhongshan Food and Drug Administration) According to the clue notice of the former State Food and Drug Administration (hereinafter referred to as State Food and Drug Administration ), a pharmaceutical company in stock, sealed and sampled on-site and inspected the capsules produced by hollow capsules produced by a capsule factory in Xinchang County, Zhejiang Province in April 2012. It was found that the chromium content in the 5 varieties of capsule drug inspection items exceeded the national standards. The Zhongshan Food and Drug Administration ordered a pharmaceutical company to provide supplier information, sales flow statistics tables and other information for purchasing pharmaceutical hollow capsules from capsule manufacturers. However, the company only provided some drug sales flow tables and did not provide a complete accounting book, and the drug sales situation provided did not match the facts.Later, the Zhongshan Food and Drug Administration decided to impose administrative penalties on the grounds that some drugs produced by a pharmaceutical company exceeded the standard and were inferior drugs, and the company had severe punishments such as refusal, evading supervision and inspection, and concealing relevant evidence materials. The penalty has been confirmed by the People's Court's effective judgment. Later, Zhongshan Food and Drug Administration believed that a certain pharmaceutical company produced inferior drugs was serious and requested to the former Food and Drug Administration of Guangdong Province (hereinafter referred to as the Guangdong Food and Drug Administration) to revoke the drug production license of a certain pharmaceutical company. After hearing, collective discussion and other procedures, the Guangdong Provincial Food and Drug Administration imposed an administrative penalty on a pharmaceutical company to revoke its drug production license on June 8, 2015. A certain pharmaceutical company was dissatisfied and applied for administrative reconsideration to the State Food and Drug Administration. The State Food and Drug Administration maintained the administrative penalty after administrative reconsideration. A certain pharmaceutical company was still dissatisfied and filed an administrative lawsuit in this case, requesting the revocation of the administrative penalty decision and the administrative reconsideration decision.
After trial, the court held that the effective judgment had determined that a pharmaceutical company had committed illegal acts of producing and selling inferior drugs, and that during the investigation and punishment of the company's production and sales of inferior drugs, the company refused, evaded inspections and other acts, which was a serious illegal act and should be punished more severely within the statutory range according to law. The Guangdong Provincial Food and Drug Administration issued an administrative penalty for revoking the drug production license with law. The administrative reconsideration decision made by the State Food and Drug Administration also has no procedural violations. The first instance court ruled in November 2016 to reject the lawsuit of a pharmaceutical company. The second-instance court ruled in March 2017 to reject the appeal and uphold the first-instance judgment.
A certain pharmaceutical company is still dissatisfied and applied for a retrial from the Supreme People's Court. After review, the Supreme People's Court held that a pharmaceutical company had not fulfilled its legal obligations in quality inspection. The 5 varieties and 7 batches of capsule drugs produced by the five varieties and total of 7 batches were produced. The chromium content tested exceeded the national standard and was considered inferior drugs. Moreover, during the supervision and inspection of the Guangdong Food and Drug Administration, there were cases of refusal and evasion of supervision and inspection such as refusal and evasion of supervision and inspection by refusing to provide a summary table of sales customers, failing to provide a complete account book and list of sold drugs in a timely and complete manner, and recalling the sold drugs inconsistent with the actual sales situation, which is a serious situation and should be punished severely. The Guangdong Provincial Food and Drug Administration imposed a punishment for revoking the certificate in accordance with the law, and the State Food and Drug Administration maintained it after reconsideration, and the procedure was legal. It was ruled to reject his retrial application in July 2018.
Drug safety involves the life safety and physical health of the people. Strict supervision must be implemented to prevent and prevent and eliminate the damage to the lives and health of the people. The food and drug supervision and administration departments shall investigate and punish illegal acts of producing and selling fake and inferior drugs in accordance with the law. On the basis of strictly grasping the serious circumstances of administrative penalties, they may revoke the enterprise's drug production administrative licenses and cut off the production and sales chain of fake and inferior drugs that endanger the lives and health of the people. The people's court will support the law enforcement behavior of the food and drug supervision and administration departments in accordance with the law in safeguarding drug safety and protecting the lives and health of the people in accordance with the law. Through the active supervision of administrative agencies and the legal review of judicial agencies, an effective barrier to punish illegal acts that endanger drug safety and protect the lives and health of the people. In this case, a certain pharmaceutical company not only had illegal acts of producing and selling inferior drugs, but also refused to cooperate with law enforcement inspections during the administrative law enforcement inspection, resulting in the inability to recall all inferior drugs that have flowed to the market, which may have adverse effects on the physical health of patients using this batch of drugs. The Guangdong Provincial Food and Drug Administration determined that the illegal acts of a pharmaceutical company were serious circumstances. While confiscating the inferior drugs produced by the company, confiscating the illegal gains and imposing a fine, it also imposed an administrative penalty for revoking its drug production administrative license, which is legal and reasonable. In accordance with the principle of adhering to the principle of legality review and respecting the administrative discretion of administrative agencies, this case rejected the lawsuit request of a certain pharmaceutical company in accordance with the law, demonstrating the people's court's determination to implement the central government's "four strictest" requirements, actively participate in social governance, severely investigate and punish illegal acts that endanger drug safety, and safeguard the legitimate rights and interests of the people.
Case 5: A pharmaceutical company sued the former Food and Drug Administration of Jinan City, Shandong Province, and the former Food and Drug Administration of Shandong Province, and the former Food and Drug Administration of Shandong Province,
——Supervision and support administrative agencies to investigate and punish the production of inferior drugs in accordance with the law. In August 2011, the former Food and Drug Administration of Jinan City, Shandong Province (hereinafter referred to as Jinan City Drug Administration) filed a case for investigation on a pharmaceutical company based on the report, and partially sealed and randomly inspected the diphenylhydrazone hydrochloride tablets in its stock. After investigation, it was found that from January 2010 to August 2011, a pharmaceutical company did not produce the raw material diphenhydrazole hydrochloride according to the approved production process. Instead, it purchased the crude diphenhydrazole hydrochloride through other companies without drug production or operation qualifications. After purification, it was made into the raw material diphenhydrazole hydrochloride, totaling 1,360 kilograms. From January 2010 to June 2011, the company sold 1,010 kilograms of the above-mentioned raw material drug diphenhydrazole hydrochloride, with a sales amount of 3.7 million yuan. A pharmaceutical company purchased crude diphenhydrazole hydrochloride and then refined it into a finished product of raw materials, which changed the production process. After the investigation was filed, the Jinan Municipal Drug Administration made the administrative penalty decision No. (Ji) Food and Drug Administration Pharmaceutical Punishment [2015] 1500003 in May 2015, confiscated 29.17 kilograms of diphenhydrazole hydrochloride and 3.7 million yuan of illegally produced diphenhydrazole and illegal income of 3.7 million yuan, and imposed a fine of 4982169.6 yuan (total fines and confiscations of 8682169.6 yuan), and ordered a pharmaceutical company to correct the illegal act. A pharmaceutical company was dissatisfied and applied for administrative reconsideration. The former Food and Drug Administration of Shandong Province (hereinafter referred to as the Shandong Food and Drug Administration) made an administrative reconsideration decision in August 2015 and upheld the above penalty decision. A pharmaceutical company was dissatisfied and filed an administrative lawsuit in this case, requesting the revocation of the above-mentioned administrative penalty decision and administrative reconsideration decision.
After trial, the court held that a pharmaceutical company did not produce the raw material diphenhydrazole hydrochloride according to the approved production process, but purchased the crude diphenhydrazole hydrochloride through other companies without drug production or operation qualifications, and refined it to make the raw material diphenhydrazole hydrochloride. Raw materials belong to the category of drugs. A pharmaceutical company purchased crude diphenhydrazole hydrochloride and then refined it into finished raw materials, which changed its production process. In accordance with the relevant provisions of the "Drug Administration Law of the People's Republic of China", it should be treated as inferior drugs. In accordance with this law, the Jinan Municipal Drug Administration made an administrative penalty decision, with clear facts determined, correct application of the law, legal procedures, and appropriate punishment. The reconsideration decision made by the Shandong Provincial Food and Drug Administration clearly determines the facts, the application of the law is correct, and the procedures are legal. The first instance court ruled in February 2016 to dismiss a pharmaceutical company's lawsuit. The second-instance court ruled in September 2016 to reject the appeal and uphold the first-instance judgment. A pharmaceutical company was dissatisfied with the first and second instance judgments and applied for a retrial. Shandong Higher People's Court ruled in June 2017 to reject the retrial application of a pharmaceutical company.
This case is a typical case in which the people's court supports the drug supervision and administration department in accordance with the law to strictly investigate and punish illegal production and sales of inferior drugs. The "Drug Administration Law of the People's Republic of China" stipulates that "except for the preparation of traditional Chinese medicine decoctions, drugs must be produced in accordance with the national drug standards and the production process approved by the drug supervision and administration department of the State Council, and the production records must be complete and accurate. If a drug manufacturer changes the production process that affects the quality of drugs, it must report to the original approval department for review and approval." In this case, a pharmaceutical company re-registered the drug diphenhydrazole hydrochloride raw materials it produced and has passed the approval, and should be produced strictly in accordance with the production process it declared. Through the "Agreement" and "Cooperation Agreement" submitted by a pharmaceutical company, it can be confirmed that the company has not applied for approval to the relevant drug supervision and administration department by purchasing crude raw materials from other companies and then refining them into finished raw materials. This behavior violates the provisions of the "Drug Administration Law of the People's Republic of China". The people's court supports the drug supervision department in punishing pharmaceutical companies for violating drug production processes in accordance with the law, which is a concrete manifestation of conscientiously implementing the central government's "four strictest" requirements for drug safety, and provides strong judicial support for administrative agencies to investigate and punish bad drug companies in accordance with the law, and ensure the safety of people's drug use.
Case 6: Qin sued the administrative penalty case of the former Food and Drug Administration of Longxi County, Gansu Province
- Supervisory and support administrative agencies to investigate and punish the production and sale of fake drugs in accordance with the law
In April 2015, the former Food and Drug Administration of Longxi County, Gansu Province (hereinafter referred to as the Longxi County Food and Drug Administration) received a report from the public about illegal drug dealers adulterating in Chinese medicinal materials, and appointed law enforcement personnel to Zhongtian Logistics Park in Longxi County for inspection. They found that there were a large number of large green leaves , dandelions, etc. on the site. After inquiring, the items involved were seized. After inspection by Dingxi Drug Inspection and Testing Center, the test results of the sample name "Dandelion" are: the characteristics and identification items do not meet the requirements. In July 2015, the Longxi County Price Certification Center accepted the entrustment of the Longxi County Food and Drug Administration to make a price appraisal conclusion for the property involved. In February 2016, the People's Procuratorate of Longxi County believed that Qin's behavior constituted the crime of producing and selling counterfeit and inferior products. Given that his behavior was an attempted crime and the circumstances of the crime were minor, he decided not to prosecute Qin's and suggested that the Longxi County Food and Drug Administration confiscate the items involved and impose administrative penalties on Qin. In January 2017, the Longxi County Food and Drug Administration issued the "Administrative Penalty Decision" on Qin's (Long) Food and Drug Administration No. 106, confiscating 377 illegally produced drugs "dandelions", totaling 24,640 kilograms, and imposed a fine of RMB 300,608 twice the value of the illegally operated drugs (150,304 yuan). Qin was dissatisfied with the administrative penalty decision and filed an administrative lawsuit in this case, requesting the revocation of the administrative penalty decision.
After trial, the court held that the illegal facts of the plaintiff Qin in this case had been determined by the " Non-Prosecution Decision " issued by the Longxi County People's Procuratorate. Based on the facts ascertained by the public prosecution agency and the evidence materials accepted, the Longxi County Food and Drug Administration determined that Qin's behavior constituted the production and sale of counterfeit drugs in the form of "other drugs impersonating this drug". The administrative penalty issued by the Longxi County Food and Drug Administration determined clearly that the facts were confirmed, the evidence was conclusive, the characterization was accurate and the law was applied correctly. Qin's behavior of purchasing dandelions in the Zhongtian Chinese Medicinal Materials Professional Market in Longxi and mixing and packaging them with large green leaves was promptly investigated and dealt with. The batch of mixed Chinese medicinal materials has been in the circulation link of the pharmaceutical market. Qin said that his claim to use the feed after mixing Chinese medicinal materials has no evidence to prove it and will not be accepted. The first instance court ruled to reject Qin's lawsuit in October 2017. The second-instance court ruled in April 2018 to reject the appeal and uphold the first-instance judgment. Qin was dissatisfied and applied for a retrial. In July 2019, Gansu Higher People's Court ruled to reject Qin's retrial application.
This case is a case where execution and are connected. Drug safety concerns the national economy and people's livelihood and directly affects the lives and health of the people. Medicines include Chinese medicinal materials, Chinese herbal medicines, Chinese patent medicines, etc. Dandelion and Daqing Leaf are both traditional Chinese medicinal materials with medicinal value included in " Pharmacopoeia of the People's Republic of China", and belong to the category of medicines. The medicinal value of dandelions mixed with large green leaves may change. After inspection institution, the characteristics and identification items do not meet the regulations. It is a case of "other drugs impersonating this kind of drug" stipulated in the "Pharmaceutical Administration Law of the People's Republic of China". It should be treated as fake drugs according to law. The number of Chinese medicinal materials involved in the case is large, with a total of more than 20,000 kilograms. If it is sold and entered into the market, it may have a widespread adverse impact on the lives and health of the people. The investigation and punishment of law enforcement departments is legitimate, timely and necessary. In the current context of the country actively promoting the high-quality development of traditional Chinese medicine and industry, and promoting traditional Chinese medicine to the world, the people's courts should support the investigation and punishment of illegal acts in the field of traditional Chinese medicinal materials in accordance with the law to safeguard the safety and health of the people's medicines and supervise and promote the healthy development of the traditional Chinese medicinal materials industry.
Case 7: A pharmacy sued the administrative penalty case of Wanzhou District Branch of the former Food and Drug Administration of Chongqing
——Supervision and support administrative agencies to investigate and punish the rental of drug business licenses and sell fake drugs in accordance with the law
In October 2015, a pharmacy (Party A) and Lin (Party B) signed a "Drugship Contract" and agreed that Party A will contract the pharmacy to Party B for management, and provide Party B with qualification certificates such as all pharmacies business licenses, drug business licenses, drug business quality management standard certification certificates and other qualification certificates to Party B for use. Later, Lin handed over the pharmacy to his mother Cai to run it. In October 2017, when the Wanzhou District Branch of the former Food and Drug Administration of Chongqing (hereinafter referred to as the Wanzhou Branch of the Chongqing Food and Drug Administration) conducted on-site inspection of the pharmacy, 12 boxes of fake drugs "Shangsuqing TM Ganoderma lucidum loquat capsules" were seized. In December of the same year, the Wanzhou Branch of Chongqing Food and Drug Administration issued the "Administrative Penalty Decision No. (Wanzhou) Pharmaceutical Penalty [2017] 97, which determined that a pharmacy illegally rented a drug business license and a pharmacy business right, provided Cai with a place and qualification certificate for selling fake drugs. He should be punished more severely, and decided to impose a fine of 20,000 yuan, and revoked the drug business license of a pharmacy. A pharmacy was dissatisfied with the revocation of the drug business license and filed an administrative lawsuit in this case, requesting the revocation of the administrative penalty for the revocation of the drug business license.
After trial, the court held that a pharmacy rented out a drug business license to Lin's business, which violated Article 12 of the "Pharmaceutical Business License Management Measures" "The "Pharmaceutical Business License" is a statutory certificate for an enterprise to engage in drug business activities, and no unit or individual may forge, alter, buy, sell, rent or lend." Because the mother of the pharmacy contractor Lin, Cai, was investigated and punished for selling fake drugs "Shangsuqing TM Ganoderma lucidum loquat capsules" while in charge of operating the pharmacy, the Wanzhou Branch of the Chongqing Food and Drug Administration determined that a pharmacy illegally rented a drug business license, which was in serious circumstances. According to Article 81 of the "Drug Administration Law of the People's Republic of China (Amendment in 2015), an administrative penalty decision to impose a fine and revoke the drug business license is in accordance with the law. The first instance court ruled in August 2018 to dismiss a pharmacy’s lawsuit. The second-instance court ruled in December 2018 to reject the appeal and uphold the first-instance judgment.
This case is a typical case where the people's court supports the drug supervision and administration department in strictly investigating and punishing illegally renting drug business licenses and selling fake drugs. my country's laws implement strict licensing management systems for drug business activities. Without obtaining a drug business license, it is prohibited to engage in drug business activities. Any illegal rental of a drug business license, allowing natural persons or organizations who do not have the qualifications to obtain drug business qualifications, and providing convenient conditions for selling fake and inferior drugs, which seriously disrupt the operating order of the drug market, should be strictly investigated and punished in accordance with the law. In this case, a pharmacy signed a "Drugship Contract" with others, providing the pharmacy's business license, drug business license and other qualification certificates to others for use, and collecting contract fees regularly. In fact, it is a profit by renting a drug business license, and it also provides a place and qualification certificate for the actual operator of the pharmacy to sell fake drugs, endangering the safety of public medication. The people's court supports administrative agencies to impose heavier penalties on a pharmacy in accordance with the law, demonstrating the people's court's determination to support the drug supervision and administration departments in providing the strictest supervision of drug business behaviors. Only by resolutely investigating and punishing illegal acts that endanger drug safety and implementing the principle of strict investigation and punishment can we maximize the safety of public drug use and safeguard the lives and health of the people, while ensuring an orderly drug market operation order and creating a good legal business environment.
Case 8: Dispute between Zhong Moumou, Du Mou A, Du Mou B and a pharmacy and Yuan Moumou's right to life
—Selling Chinese herbal medicines should be informed of the use and precautions
On July 6, 2017, Du Moumou went to a pharmacy to buy fragrant and peel 150 grams, and took 150 grams of fragrant and peel water that night. He developed chest tightness, , nausea, vomiting, and was sent to the hospital by his family, and died after ineffective rescue. The market and quality supervision and management department commissioned an inspection agency to sample the fragrant peel involved in the case, and the inspection results were quality-qualified products.A judicial appraisal institute issued the "Opinion for Autopsy and Identification", proving that Du Moumou met the excessive use of fragrant and peel, causing poisoning to death, which was the main cause of death; the underlying disease of coronary heart disease he suffered from was an auxiliary and promotes death. Du Moumou's wife Zhong Moumou, sons Du Mou A and Du Mou B sued the court on the grounds that a pharmacy sold fragrant peas to Du Moumou without a practicing physician or salesperson without an job certificate, but did not inform the decoction method and precautions, resulting in the death of poison, and demanded that a pharmacy and its shareholder Yuan Moumou bear the responsibility for infringement of .
After trial, the court held that Article 19 of the "Pharmaceutical Administration Law of the People's Republic of China (Amendment in 2015)" stipulates that "drug business enterprises must sell drugs accurately and correctly explain the methods, dosage and precautions..." The appraisal report pointed out that Du Moumou was killed by poisoning by overdose of Xiangjiapi. A pharmacy is the seller of Xiangjiapi. Article 167 (4) of the "Pharmaceutical Business Quality Management Standards (2016)" stipulates that "the sales of drugs shall meet the following requirements: (4) Sales of Chinese herbal medicines should be accurate in the measurement and inform the decoction method and precautions; providing decoction services for decoctions on behalf of Chinese herbal medicines shall comply with relevant national regulations." A pharmacy is obliged to inform Du Moumou of the methods and precautions for decoctions when selling fragrant and skin. The existing evidence is not enough to prove that a pharmacy has fulfilled its obligation to inform, and a pharmacy has the obligation to inform but fails to act, which is at fault, which constitutes infringement; the damage result in this case is Du Moumou's death, and the fault of a pharmacy is causally linked to Du Moumou's death, and a pharmacy should bear the fault liability . Because Du Moumou's death was caused by the pharmacy's failure to fulfill its obligation to inform and his own faults and his own illness, the pharmacy and Du Moumou should each bear 50% of the responsibility. The judgment was then made: 1. A pharmacy compensated Zhong, Du A and Du B for treatment expenses of 1249.5 yuan, funeral expenses of 28,735 yuan, death compensation of 315,403 yuan, appraisal fee of 16,000 yuan, and other expenses of 8,176 yuan, totaling 184,781.75 yuan; 2. A pharmacy compensated Zhong, Du A and Du B for mental comfort expenses of 10,000 yuan; 3. A pharmacy should fulfill the above-mentioned compensation obligations within ten days after the judgment takes effect; 4. Dismissed other litigation requests of Zhong, Du A and Du B.
Chinese herbal medicines do not have clear instructions like Western medicines. The efficacy, toxicity, dosage, etc. of Chinese herbal medicines are not well known to the general public. Once the medication is used incorrectly, it is very likely to threaten life, health and safety, causing tragedies similar to this case. When selling Chinese herbal medicines, you should measure accurately and inform the decoction method and precautions. The pharmacy that failed to fulfill the obligation to inform the purchaser shall bear corresponding tort liability for the death caused by excessive use of fragrant and peel, and serves as a warning to the operators selling Chinese herbal medicines, warns them to fully pay attention to the life, health and safety of the purchaser. When selling Chinese herbal medicines, they should fully fulfill their obligation to inform the buyer of the information and inform them of the decoction and precautions of the Chinese herbal medicines.
Case Nine: Xu’s contract dispute with a pharmacy
—Disinfection product labeling treatment function misleads consumers to purchase, constitute fraud
Xu purchased 10 boxes of "Buzhou" Pikangle preparations in a pharmacy in June 2016, and paid a total of 180 yuan. The "Instructions for the "Buzhou" Pikangle Preparation" states that the "effect" is to inhibit and kill skin fungi and mold; the "approval number" is Luweixiao Certificate (2013) No. 0029. The scope of application of "Peer Residence" in the "Buzhou Series Product Introduction": Skin infections caused by fungi, such as beriberi, tinea pectoris, tinea capitis, tinea thorns, tinea thorns, tinea purulent ringworm, tinea phobia (sweat spots), tinea erythromycosis, candidiasis and all fungal skin itching; product advantages: the old saying "If you practice medicine, you will be embarrassed to treat tinea thorns." Buzhou brand Pi Kangle, which eliminates fungal tinea disease, has the leading effect. Xu believed that the pharmacy's act of impersonating non-drugs to sell to him was illegal, so he sued the court and asked the pharmacy to return the shopping payment and compensate him for his losses three times the Consumer Rights Protection Law.
After trial, the court held that the operators should provide consumers with information on the quality, performance, purpose, validity period, etc. of goods or services, and should not make false or misleading publicity.The approval number of the product involved is × Weixiao Certificate (20××), which is a disinfection product (disinfection product), but the product instructions and product introduction indicate that it has the effect of treating fungal tinea disease. According to Article 48 of the "Drug Administration Law of the People's Republic of China (Amendment in 2015)" "Prohibition (including preparation, the same below) and sale of counterfeit drugs. If one of the following circumstances occurs, it is a counterfeit drug:... (2) Use non-drugs to pretend to be a drug or use other drugs to pretend to be such drugs", the pharmacy sells non-drugs to pretend to be a drug, causing Xu to make an incorrect expression of intention, which constitutes fraud. Xu asked the pharmacy to return the shopping payment and compensate him for his losses at three times the price, in accordance with the law. The court then ruled that the pharmacy would return the shopping payment of Xu 180 yuan and compensate him for the loss of 540 yuan.
pharmacies spread all over the streets and alleys of the city, bringing convenience to the people in time to purchase medicines and eliminate illnesses. However, some pharmaceutical companies have illegal acts of illegally promoting and selling disinfectants, health products that have therapeutic functions, and misleading consumers, endangering people's health. Disinfection products are not medicines and do not have the effect of regulating the physiological functions of the human body. They cannot be used to treat diseases and are obviously different from medicines. The "Disination Management Measures" clearly stipulate that the labels (including instructions) and publicity content of disinfection products must be true and must not appear or imply the therapeutic effect on the disease. When purchasing products, consumers must pay attention to the product approval number, strictly distinguish between "national medicine standard" and "hygienic and anti-virus certificate" products, and do not use disinfection products as medicine to avoid delaying the disease. In this case, the disinfection products involved in the case marked with treatment function are fake drugs, and the drug business enterprise's wrong guidance to consumers to purchase drugs constitute fraud and apply the provisions of punitive compensation. This can not only play a due warning role for drug business enterprises, standardize their business activities, but also help guide consumers to carefully and rationally purchase therapeutic drugs and protect consumers' legitimate rights and interests.
Case 10: Contract dispute case between Yang Moumou v. a pharmacy
—Selling drugs without product batch number should bear the liability for compensation
A pharmacy is an individual business registered by the Market Supervision Administration and operates for individuals. Its business scope is: sales of prescription drugs and over-the-counter drugs, antibiotics, Chinese patent medicines, chemical preparations, health products, and pre-packaged foods (projects required to be approved according to law and business activities can only be carried out after approval by relevant departments). On June 10, 2019, Yang went to a pharmacy to buy "Viagra". Under the introduction of the salesperson, he purchased 2 large boxes of "Cordyceps Sperm Capsules", each with a unit price of 500 yuan; 1 large box of "Golden Viagra", with a unit price of 500 yuan; 1 large box of "Kidney Treasure Tablets", with a unit price of 500 yuan. The total price is 2,000 yuan. After Yang Moumou paid the price in cash, the salesperson did not issue a small receipt. At Yang Moumou's request, the salesperson handwritten a shopping list (a pharmacy payment form) and stamped the "Cash receipt stamp for a pharmacy." Later, Yang Moumou checked the information of the purchased "Cordyceps sinensis capsules" through the official website of the State Food and Drug Administration but failed. He filed a lawsuit in this case on the grounds that the purchased product was a toxic and harmful counterfeit drug.
After trial, the court held that the outer packaging of the goods involved in this case was marked with the product efficacy, and its built-in instructions clearly state its main ingredients, applicable population, usage and dosage, etc. The above records meet the definition requirements of the drugs in Article 2, paragraph 2 of the "Drug Administration Law of the People's Republic of China (Revised in 2019)" "The drugs referred to in this law refer to substances used to prevent, treat, and diagnose human diseases, purposefully regulate human physiological functions, and stipulate the main indications, usage and dosage of indications, usage and dosage, including traditional Chinese medicine, chemical drugs and biological products, etc.". Therefore, the court determined that the goods involved in this case "Cordyceps sinensis capsules", "Golden Viagra" and "Shenbao Tablets" were drugs.
Article 98, paragraph 1 of the "Drug Administration Law of the People's Republic of China (Revised in 2019)" stipulates that "production (including preparation, the same below), sales, and use of fake and inferior drugs are prohibited."The third paragraph stipulates that "if any of the following circumstances occurs, it is a inferior drug: (1) The content of the drug ingredients does not meet the national standards; (2) Contaminated drugs; (3) Drugs that have not been marked or changed in validity period; (4) Drugs that have not been indicated or changed in product batch number; (5) Drugs that have exceeded the validity period; (6) Drugs that have added preservatives and auxiliary materials without authorization; (7) Other drugs that do not meet the drug standards." Both parties in this case acknowledge the search results for information about "Cordyceps Sperm Capsules", "Golden Viagra" and "Shenbao Tablets" on the official website of the State Food and Drug Administration. If the "Cordyceps Sperm Capsules", "Golden Viagra" and "Shenbao Tablets" sold to Yang Moumou, there is no drug product batch number in the drug. Yang Moumou requested a judgment The lawsuit request to order a pharmacy to refund 2,000 yuan of the goods and make compensation at ten times the price of the goods is in accordance with the law. A pharmacy was ordered to compensate Yang Moumou for 2,000 yuan of the goods and pay compensation of 20,000 yuan.
Food and drug safety is related to the physical health and life safety of the people, and the state has always taken strict control measures. Article 144, paragraph 3 of the "Drug Administration Law of the People's Republic of China (Revised in 2019)" "If a fake drug or inferior drug is produced or a bad drug is sold or used even though it is known that it is a fake drug or inferior drug, the victim or his close relatives may also request to pay a ten times the price or three times the loss in addition to requesting compensation for the losses; if the amount of additional compensation is less than one thousand yuan, it is one thousand yuan. "The newly revised Drug Administration Law implements stricter management of drug safety, and is of great significance to the production of fake drugs, inferior drugs, or the behavior of selling and using them even though they know it is fake drugs and inferior drugs, and to increase the amount of compensation for the victims' losses when purchasing fake drugs. It is of great significance to purify the drug market, improve the public's awareness of food and drug safety, and promote citizens to know and abide by the law.
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