China News Service, April 28. According to the official WeChat account of the Supreme People's Court on the 28th, in order to further do a good job in drug-related trials in 2022, punish crimes endangering drug safety in accordance with the law, try drug-related administrative and civil cases in accordance with the law, and maintain the drug management order, To protect the lives and health of the people and create a strong atmosphere for the whole society to jointly safeguard drug safety, the Supreme People's Court issued 10 typical criminal, administrative and civil cases involving drug safety.
Drug safety concerns the life and health of the people and the overall situation of social security and stability. It is an important livelihood issue.
People's courts at all levels across the country attach great importance to drug safety trials, strictly implement the "four strictest" requirements, try criminal, administrative and civil cases involving drugs in accordance with the law, severely punish crimes endangering drug safety, protect the legitimate rights and interests of consumers, and supervise and support drug-related crimes. Drug safety administration and law enforcement, and promote the establishment of a standardized, orderly, safe and secure drug market environment.
From 2013 to 2021, courts across the country have concluded more than 27,000 first-instance criminal cases for the crime of producing, selling, and supplying counterfeit medicines, the crime of producing, selling, and supplying inferior medicines, and the crime of obstructing drug administration, with more than 36,000 people sentenced, and a large number of criminal cases. Crimes related to drug safety are convicted and punished with related crimes such as the crime of producing and selling fake and shoddy products, effectively deterring and cracking down on crimes that endanger drug safety.
At the same time, it has concluded a large number of administrative and civil cases involving counterfeit and inferior drugs, effectively maintaining the order of drug operation and management, and effectively protecting 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 successively formulated and promulgated the "Regulations on Several Issues Concerning the Application of Law in the Trial of Food and Drug Dispute Cases", "Measures for the Linkage of Food and Drug Administrative Law Enforcement and Criminal Justice", and "On Handling Hazardous Drug Safety". Judicial interpretations and normative documents, such as the Interpretation on Several Issues Concerning the Application of Law in Criminal Cases, have continuously adapted to the new needs of legal protection of drug safety in the new era, and have played an important role in ensuring the safety of the people's medication.
At the same time, the Supreme People's Court actively cooperates with relevant departments to promote the establishment and improvement of the working mechanism for the connection between drug administrative law enforcement and the judiciary, participate in the comprehensive social management of drug safety, form a joint force in the work of legal guarantee of drug safety, and jointly promote the strengthening of the supervision of the whole process of drug safety.
In the next step, the Supreme People's Court will conduct in-depth investigations into the new situations and problems faced by the judicial practice of punishing crimes endangering drug safety, and guide local courts at all levels to effectively play their role in adjudication, severely punish crimes endangering drug safety in accordance with the law, and try cases in the field of drug safety in accordance with the law. For administrative and civil cases, supervise and support drug authorities to strengthen supervision in accordance with the law, and effectively protect the lives and health of the people.
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Case 1: The production and sale of counterfeit medicines by Niu Moumou and others - the sale of counterfeit nine-valent human papillomavirus vaccine with syringes filled with saline
Case 2: The case of Gao and others producing and selling counterfeit medicines - "Black Workshop" mixes traditional Chinese medicine and western medicine into powder and sells it as pure traditional Chinese medicine
Case 3: A case of a tumor drug company in Beijing selling counterfeit drugs - the drug company purchased and sold counterfeit drugs through illegal channels
Case 4: A pharmaceutical company sued the former Guangdong Provincial Food and Drug Administration and the former State Food and Drug Administration for administrative punishment and administrative reconsideration - supervising and supporting administrative agencies to investigate and punish the production and sale of inferior drugs according to law
Case 5: A pharmaceutical company sued the former Jinan City Food and Drug Administration of Shandong Province and the former Shandong Province Food and Drug Administration for administrative punishment and administrative reconsideration - supervising and supporting administrative agencies to investigate and punish the production of inferior drugs according to law
Case 6: A case of Qin v. the former Food and Drug Administration of Longxi County, Gansu Province for administrative punishment - supervising and supporting administrative agencies to investigate and deal with the production and sale of counterfeit drugs in accordance with the law
Case 7: A pharmacy sued the former Chongqing Municipal Food and Drug Administration Wanzhou Sub-bureau for administrative punishment - Supervision and support of the administrative organ in investigating and punishing the leasing of drug business licenses and the sale of counterfeit drugs
Case 8: Dispute over the right to life between Zhong Moumou, Du Moujia, Du Mouyi and a pharmacy and Yuan Moumou - The method of decoction and precautions should be notified when selling Chinese herbal medicines
Case 9: Dispute over a sales contract between Xu and a pharmacy - Disinfection product labeling treatment function misleading consumers to buy constitutes fraud
Case 10: Yang Moumou v. a pharmacy contract dispute case - sales of medicines without product batch numbers should be liable for compensation
Case 1: The case of Niu Moumou and others producing and selling counterfeit medicines
——The sale of counterfeit 9-valent human papillomavirus vaccine with syringes filled with physiological saline
brief case
In the first half of 2018, after learning that the 9-valent human papillomavirus vaccine (hereinafter referred to as the 9-valent vaccine) was selling well, the defendant, Niu, sought packaging, consumables and related processes similar to the genuine product, and prepared to produce counterfeit products.
From July to October 2018, Niu purchased more than 40,000 sets of needles, push rods, plugs, needles and other items through others, and ordered packaging boxes, instructions, labels and other items for counterfeit 9-valent vaccines A total of more than 41,000 sets.
During this period, Niu Moumou and co-defendant Zhang Moumou produced counterfeit 9-valent vaccine in Shanxian County, Shandong Province by filling the syringe with physiological saline, and then produced a total of counterfeit 9-valent vaccine through trademark sticking, tray plastic sealing and other processes. 23,000 sticks.
Niu Moumou and Zhang Moumou sold 9,004 pieces of the above-mentioned counterfeit nine-valent vaccine to the outside world through multiple medical and beauty WeChat groups and other channels, with a sales amount of more than 1.2 million yuan.
According to the inspection by the Suzhou Drug Inspection and Testing Research Center, the liquid composition of the counterfeit nine-valent vaccine sampled and submitted for inspection is basically the same as that of normal saline.
referee result
The court held that the joint production and sale of fake vaccines by the defendants Niu Moumou and Zhang Moumou constituted the crime of producing and selling fake medicines.
Niu Moumou and Zhang Moumou's production and sales amounted to more than 1.2 million yuan, with "other particularly serious circumstances".
The production and sale of counterfeit medicines are injectable vaccines and should be severely punished as appropriate.
In the joint crime, Niu Moumou was the principal offender and Zhang Moumou was the accomplice, and Zhang Moumou was given a lighter punishment.
Both defendants pleaded guilty.
Accordingly, the defendant Niu Moumou was sentenced to 15 years in prison and a fine of RMB 1.5 million for the crime of producing and selling counterfeit medicines; the defendant Zhang Moumou was sentenced to 13 years in prison and a fine of RMB 1.5 million. million dollar.
typical meaning
Vaccines are preventive biological products used for human immunization in order to prevent and control the occurrence and prevalence of diseases, and are drugs under special administration by the state.
Vaccines include immunization program vaccines and non-immunization program vaccines. 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, quadrivalent and 9-valent, of which 9-valent vaccine is preventable. The most diverse vaccine against human papillomavirus, the optimal age for vaccination is 16 to 26 years old.
In this case, the two defendants produced and sold counterfeit nine-valent human papillomavirus vaccine by filling physiological saline with needles, which falls under the circumstances of "passing non-drugs as drugs" as stipulated in the Drug Administration Law of the People's Republic of China, and should be considered as counterfeit medicine.
Such crimes not only make consumers pay high prices but fail to get the corresponding immune effect, but also some consumers miss the best age and timing of vaccination, causing serious social harm and should be severely punished in accordance with the law.
For the majority of consumers, it is necessary to go to regular medical institutions to get vaccinated to ensure the safety and effectiveness of vaccination.
Case 2: The production and sale of counterfeit drugs by Mr. Gao
——"Black Workshop" mixes traditional Chinese medicine and western medicine into powder and sells it as pure traditional Chinese medicine
brief case
From 2018 to September 2020, in order to obtain illegal benefits, the defendant Gao used the traditional Chinese medicinal material Shouwu in his residence in Nanhengli, Puning City, Guangdong Province without obtaining a drug production license or drug business license. , licorice, anise and western medicine bromhexine, oxytetracycline tablets, compound licorice tablets, calcium hydrogen phosphate chewable tablets, prednisone acetate, chlorpheniramine maleate, etc. were mixed and ground into powder in a certain proportion, and the defendant was hired Person Li subpackages and packs the powder into finished products.
Gao used the fake name of "Special Kechuanling" and fabricated the powder as an "ancestral secret recipe" and "pure traditional Chinese medicine ingredients". It mainly treats cough, tuberculosis, asthma, and bronchitis. Sales, the total sales amount is more than 1.86 million yuan.
Li also bought the above-mentioned counterfeit medicines at a low price from Gao and sold them to the defendant Huang and others at a higher price.
It was determined by the Huai'an City Market Supervision and Administration Bureau of Jiangsu Province that the drugs involved were counterfeit drugs.
referee result
The court held that the production and sale of counterfeit medicines by the defendant Gao and others constituted the crime of producing and selling counterfeit medicines.
Gao Mou's production and sales amounted to 1.86 million yuan, with "other particularly serious circumstances".
Accordingly, the defendant Gao was sentenced to ten years and nine months in prison for the crime of producing and selling counterfeit medicines and a fine of RMB 3.72 million.
The remaining defendants were sentenced to one year and six months to ten years and three months in prison and fined.
typical meaning
In recent years, some criminals have taken advantage of the public's trust in traditional Chinese medicine, and under the guise of "ancestral secret recipes" and "pure traditional Chinese medicine ingredients", they have secretly prepared traditional Chinese medicines. It also brings serious hidden dangers to drug safety and human health.
The "Pharmaceutical Administration Law of the People's Republic of China" stipulates that "non-drugs pass off as drugs or other drugs pass as such drugs" as counterfeit drugs.
In this case, the defendant Gao mixed a variety of western medicines into traditional Chinese medicines and sold them as pure traditional Chinese medicines. Convicted and punished for the crime of producing and selling counterfeit medicines.
This case also reminds consumers not to believe in false propaganda such as "ancestral secret recipes", and should purchase drugs through formal channels to ensure drug safety.
Case 3: A case of selling counterfeit drugs by a tumor drug company in Beijing
——Drug companies procure and sell counterfeit medicines through illegal channels
brief case
In August 2018, the defendant unit, a Beijing Oncology Drug Co., Ltd., purchased the drug "Ridaxian (Thymus Faxin for Injection)" at a low price through informal channels.
The defendants Lu, Zhao, and Zhang, as the directly responsible persons in charge of the company, and the defendants Wu and Wang, as the directly responsible persons in charge of the sales of the company, knew that the above-mentioned drugs were purchased from illegal channels without legal procedures. Under the condition that the price is lower than the normal price, the above-mentioned "Ridaxian (Thymus Faxin for Injection)" was sold to the victim Wu Moumou twice in the name of the unit on September 7 and 11, 2018 in Dongcheng District, Beijing. "A total of 8 boxes, the total sales amount is 9600 yuan.
According to the inspection by the China National Institute for Food and Drug Control, the “Ridaxian (Thymus for Injection)” involved in the case did not meet the requirements according to the registration standards for imported drugs, which is inconsistent with the national drug standards.
It was determined by the Beijing Dongcheng District Market Supervision and Administration Bureau that the drugs involved were counterfeit drugs.
referee result
After trial, the court held that the sales of counterfeit drugs by a certain tumor drug company in Beijing constituted the crime of selling counterfeit drugs.
Defendants Lu, Zhao, and Zhang are directly responsible for the company's sales of counterfeit drugs, and defendants Wu and Wang are other directly responsible officers for the company's sales of counterfeit drugs, all of which constitute the crime of selling counterfeit drugs.
Since the drug involved is an injection drug, it should be given a heavier punishment as appropriate.
Given that Lu and Zhao had surrendered, and the defendants voluntarily pleaded guilty and repented, they could be given a lighter punishment in accordance with the law.
Accordingly, the defendant, a Beijing Tumor Drug Co., Ltd., was sentenced to a fine of RMB 50,000 for the crime of selling counterfeit drugs, and Lu and other defendants were sentenced to nine months and 15 days in prison and a fine of RMB 10,000.
typical meaning
This case is a typical case of a licensed pharmaceutical company selling counterfeit drugs.
In order to strengthen drug management and ensure drug quality, the "Pharmaceutical Administration Law of the People's Republic of China" implements a strict licensing system for drug production and sales, and requires drug dealers to establish and implement a purchase inspection and acceptance system when purchasing drugs. The drug qualification certificate and other labels shall not be purchased and sold if they do not meet the prescribed requirements.
In practice, some drug dealers purchase drugs from individuals and units without production and business licenses, and fail to implement the purchase inspection and acceptance system, which allows illegal elements in upstream production and sales of counterfeit drugs to take advantage.
In order to reduce costs, the defendants Lu and others violated the relevant provisions of the Drug Administration Law of the People's Republic of China by purchasing drugs without legal procedures through illegal channels at low prices.
The drug involved in this case, Ridaxian (Thymus Faxin for Injection), is an injectable drug. The sale of such counterfeit drugs has seriously infringed upon the public's drug safety and life and health, and should be punished according to law.
Case 4: A pharmaceutical company sued the former Guangdong Food and Drug Administration and the former State Food and Drug Administration for administrative punishment and administrative reconsideration
——Supervise and support administrative organs to investigate and punish the production and sale of inferior drugs according to law
brief case
In April 2012, the former Food and Drug Administration of Zhongshan City, Guangdong Province (hereinafter referred to as the Zhongshan Food and Drug Administration) issued a notice to a pharmaceutical company in April 2012 based on the clues issued by the former State Food and Drug Administration (hereinafter referred to as the State Food and Drug Administration). For the inventory, the capsule medicines produced by hollow capsules produced by a capsule factory in Xinchang County, Zhejiang Province and other enterprises were used for sealing and on-site sampling and inspection. It was found that the content of chromium in the inspection items of 7 batches of capsule medicines of 5 varieties exceeded the national standard.
Zhongshan Food and Drug Administration ordered a pharmaceutical company to provide information on suppliers and sales flow statistics of hollow medicinal capsules purchased from capsule manufacturers, but the company only provided a partial drug sales flow table, and did not provide a complete Accounting books, and the sales of medicines provided do not match the facts.
Later, the Zhongshan Food and Drug Administration decided to confiscate the inferior drugs on the grounds that some of the drugs produced by a pharmaceutical company had excessive chromium content and were substandard drugs, and the company refused, evaded supervision and inspection, and concealed relevant evidence materials. The administrative punishment of medicines, confiscation of illegal gains and fines has been confirmed by the effective judgment of the people's court.
Afterwards, Zhongshan Food and Drug Administration believed that the production of inferior drugs by a pharmaceutical company was serious, and requested the former Guangdong Food and Drug Administration (hereinafter referred to as Guangdong Food and Drug Administration) to revoke the drug production license of a pharmaceutical company.
Guangdong Food and Drug Administration, after hearings, collective discussions and other procedures, imposed an administrative penalty of revoking a pharmaceutical production license on June 8, 2015 to a pharmaceutical company.
A pharmaceutical company refused to accept it and applied to the State Food and Drug Administration for administrative reconsideration.
The State Food and Drug Administration upheld the administrative penalty after administrative reconsideration.
A pharmaceutical company still refused to accept it and filed an administrative lawsuit in this case, requesting to revoke the administrative penalty decision and the administrative reconsideration decision.
referee result
After hearing the court, the court held that the effective judgment had determined that a pharmaceutical company had violated the law in the production and sale of inferior drugs, and during the process of investigating and punishing the company's production and sale of inferior drugs by the Zhongshan Food and Drug Administration, the company had behaviors such as refusal and evasion of inspection, etc. For serious violations, they should be given a heavier punishment within the statutory range in accordance with the law, and the Guangdong Food and Drug Administration’s administrative punishment of revoking the drug production license is justified by law.
There is no procedural violation of the administrative reconsideration decision made by the State Food and Drug Administration.
The court of first instance ruled in November 2016 to dismiss the claim of a pharmaceutical company.
The court of second instance dismissed the appeal in March 2017 and upheld the judgment of first instance.
A pharmaceutical company still refused to accept it and applied to the Supreme People's Court for a retrial.
After review, the Supreme People's Court held that a certain pharmaceutical company failed to fulfill its legal obligation of quality inspection and produced 7 batches of 5 varieties of capsule medicines. The chromium content exceeded the national standard after testing, and they were inferior medicines; During the supervision and inspection process of the Food and Drug Administration, refusal or evasion of supervision and inspection, such as refusal to provide a summary table of sales customers, failure to provide timely and complete account books and lists of drugs for sale, and inconsistency between recalling sold drugs and actual sales, are considered serious and should be avoided. Severe penalties are imposed.
The Guangdong Provincial Food and Drug Administration issued a penalty of suspension in accordance with the law, and the State Food and Drug Administration maintained it after reconsideration, and the procedure was legal.
In July 2018, it ruled to reject its retrial application.
typical meaning
Drug safety involves people's lives and health, and strict supervision must be implemented to prevent counterfeit and inferior drugs from causing damage to people's lives and health.
The food and drug supervision and administration department investigates and punishes illegal acts of producing and selling counterfeit and inferior drugs in accordance with the law, and may, on the basis of strictly grasping the seriousness of the administrative punishment, revoke the administrative license of the enterprise for drug production, and cut off the fake and inferior drugs that endanger the lives and health of the people. Pharmaceutical production and sales chain.
The people's court shall support the law enforcement actions of the food and drug administration to maintain drug safety and protect people's lives and health in accordance with the law.
Through the active supervision of the administrative organs and the legal review of the judicial organs, an effective barrier for punishing illegal acts endangering drug safety and protecting the lives and health of the people has been jointly built.
In this case, a pharmaceutical company not only had the illegal act of producing and selling inferior drugs, but also refused to cooperate with the law enforcement inspection during the process of administrative law enforcement inspection. As a result, all inferior drugs that had been released to the market could not be recalled and may be used for The health of the patients of this batch of medicines was adversely affected.
The Guangdong Provincial Food and Drug Administration determined that the illegal behavior of a pharmaceutical company was a serious circumstance, and it confiscated the inferior drugs produced by the company, confiscated the illegal income and imposed a fine, and also imposed an administrative penalty of revoking its administrative license for drug production. , legal and reasonable.
Based on the principle of adhering to the legality review and respecting the administrative discretion of the administrative organ, this case dismissed the lawsuit of a pharmaceutical company in accordance with the law. Illegal acts of drug safety and the concept of adjudication for safeguarding the legitimate rights and interests of the people.
Case 5: A pharmaceutical company sued the former Jinan City Food and Drug Administration of Shandong Province and the former Shandong Province Food and Drug Administration for administrative punishment and administrative reconsideration
——Supervise and support administrative organs to investigate and punish the production of inferior drugs according to law
brief case
In August 2011, the former Food and Drug Administration of Jinan City, Shandong Province (hereinafter referred to as Jinan Food and Drug Administration) initiated an investigation on a pharmaceutical company according to the report, and partially sealed up and sampled the Trihexysol Hydrochloride Tablets in its inventory. .
After investigation, from January 2010 to August 2011, a pharmaceutical company did not produce the raw material trihexyphenidyl hydrochloride in accordance with the approved production process, but purchased trihexyphenidyl hydrochloride through other companies without drug production or business qualifications. The crude product was refined to make the raw material trihexyphenidyl hydrochloride, totaling 1360 kg.
From January 2010 to June 2011, the company sold 1,010 kilograms of the above-mentioned raw material, trihexyphenidyl hydrochloride, with a sales amount of 3.7 million yuan.
A pharmaceutical company purchased crude trihexyphenidyl hydrochloride and refined it into finished APIs, which changed the production process.
After the Jinan Food and Drug Administration investigated the case, in May 2015, it issued an administrative penalty decision (Ji) Food and Drug Administration Punishment [2015] No. 1500003, confiscating 29.17 kilograms of illegally produced trihexyphenidyl hydrochloride and 3.7 million yuan of illegal gains. A fine of 4,982,169.6 yuan (a total of 8,682,169.6 yuan) was imposed on the illegal production and sale of inferior drugs (4,982,169.6 yuan), and a pharmaceutical company was ordered to correct the illegal act.
A pharmaceutical company refused to accept it and applied for administrative reconsideration.
The former Shandong Food and Drug Administration (hereinafter referred to as the Shandong Food and Drug Administration) made an administrative reconsideration decision in August 2015, upholding the above penalty decision.
A pharmaceutical company refused to accept it and filed an administrative lawsuit in this case, requesting to revoke the above-mentioned administrative penalty decision and administrative reconsideration decision.
referee result
After trial, the court held that a pharmaceutical company did not produce the raw material trihexyphenidyl hydrochloride in accordance with the approved production process, but purchased crude trihexyl hydrochloride through other companies without drug production or business qualifications, and refined it to make the raw material medicine. Trihexyphenidyl Hydrochloride.
APIs belong to the category of drugs. A pharmaceutical company purchased crude trihexyphenidyl hydrochloride and refined them into finished APIs, which changed its production process. According to the relevant provisions of the Drug Administration Law of the People's Republic of China, it should be treated as an inferior drug.
According to the law, Jinan Food and Drug Administration made an administrative penalty decision, the facts were clear, the law was applied correctly, the procedure was legal, and the punishment was appropriate.
The reconsideration decision made by the Shandong Food and Drug Administration found that the facts were clear, the applicable laws were correct, and the procedures were legal.
The court of first instance ruled in February 2016 to reject the lawsuit of a pharmaceutical company.
The court of second instance dismissed the appeal in September 2016 and upheld the judgment of first instance.
A pharmaceutical company refused to accept the judgment of the first and second instance and applied for a retrial.
The Shandong Higher People's Court ruled in June 2017 to reject a pharmaceutical company's application for retrial.
typical meaning
This case is a typical case in which the people's court supports the drug supervision and administration department to strictly investigate and deal with the illegal production and sale of inferior drugs.
The "Pharmaceutical Administration Law of the People's Republic of China" stipulates that "except for the processing of traditional Chinese medicine pieces, drugs must be produced in accordance with national drug standards and the production process approved by the drug regulatory department of the State Council, and the production records must be complete and accurate. Changes in drug production enterprises affect the quality of drugs. The production process must be reported to the original approval department for review and approval.”
In this case, a pharmaceutical company has re-registered the raw materials of trihexyphenidyl hydrochloride it produced and has passed the examination and approval, and it should be produced in strict accordance with its declared production process.
Through the "Agreement", "Cooperation Agreement" and other materials submitted by a pharmaceutical company, it can be confirmed that the company did not apply to the relevant drug supervision and management department by purchasing crude APIs from other companies and refining them into finished APIs by themselves. Approved, this behavior violated the provisions of the Drug Administration Law of the People's Republic of China.
The people's court's legal support for the drug regulatory department's punishment of pharmaceutical companies for violating the drug production process is a concrete manifestation of conscientiously implementing the "four strictest" requirements of the central government on drug safety, and for the administrative organs to investigate and punish bad drug companies producing counterfeit and inferior drugs. It has provided strong judicial support to ensure the safety of the people's drug use.
Case 6: A case of Qin v. the former Food and Drug Administration of Longxi County, Gansu Province for administrative punishment
——Supervise and support administrative organs to investigate and punish the production and sale of counterfeit medicines according to law
brief case
In April 2015, the former Food and Drug Administration of Longxi County, Gansu Province (hereinafter referred to as the Food and Drug Administration of Longxi County) received reports from the public about the adulteration of traditional Chinese medicinal materials by illegal drug dealers, and assigned law enforcement officers to go to the middle of Longxi County. Tian Logistics Park conducted an inspection and found that there were a large number of large green leaves and dandelions at the scene. After inquiring, the items involved in the case were seized.
After the inspection of Dingxi Drug Inspection and Testing Center, the inspection result of the sample name "Dandelion" is: the traits and identification items do not meet the requirements.
In July 2015, the Longxi County Price Certification Center was entrusted by the Longxi County Food and Drug Administration to make a price appraisal conclusion for the property involved.
In February 2016, the Longxi County People's Procuratorate believed that Qin's actions constituted the crime of producing and selling fake and shoddy products. In view of the fact that his behavior was an attempted crime and the crime was minor, it decided not to prosecute Qin. It was suggested that the Longxi County Food and Drug Administration should investigate the case. The items were confiscated and Qin was given an administrative penalty.
In January 2017, the Food and Drug Administration of Longxi County issued (Long) Food and Drug Administration Punishment [2017] No. 106 "Administrative Penalty Decision" to Qin, confiscating 377 illegally produced drugs "dandelion", totaling 24,640 kilograms, A fine of 300,608 yuan, double the value of the illegal drug business (150,304 yuan), was imposed.
Qin refused to accept the administrative penalty decision and filed an administrative lawsuit in this case, requesting to revoke the administrative penalty decision.
referee result
After hearing, the court held that the fact that the plaintiff Qin violated the law has been confirmed by the "Decision not to Prosecute" issued by the Longxi County People's Procuratorate. The behavior of a certain person constituted the production and sale of counterfeit drugs in the way of "other drugs impersonating this kind of drugs". The administrative penalty issued by the Longxi Food and Drug Administration has clear facts, conclusive evidence, accurate characterization and correct application of the law.
Qin bought dandelion in Longxi Zhongtian Chinese medicinal material professional market, mixed and packaged with Daqingye, and was promptly investigated and dealt with. The batch of mixed Chinese medicinal materials was already in the circulation of the pharmaceutical market. Qin said that after purchasing the Chinese medicinal materials and mixing them When claims of feed use are not substantiated by evidence, they are not accepted.
The court of first instance ruled in October 2017 to reject Qin's claim.
The court of second instance dismissed the appeal in April 2018 and upheld the judgment of first instance.
Qin refused to accept it and applied for a retrial.
In July 2019, the Higher People's Court of Gansu Province ruled to reject Qin's application for retrial.
typical meaning
This case is a case involving execution.
Drug safety is related to the national economy and people's livelihood, and directly affects the lives and health of the people.
Medicines include Chinese herbal medicines, Chinese herbal decoction pieces, Chinese patent medicines, etc. Dandelion and Daqingye are Chinese herbal medicines with medicinal value included in the "Pharmacopoeia of the People's Republic of China" and belong to the category of medicines.
Mixing Daqingye into dandelion to pretend to be dandelion, so that the medicinal value of dandelion mixed with a large amount of Daqingye may change. After inspection by the inspection agency, its properties and identification items are not in compliance with the regulations. The case of "other drugs pretending to be such drugs" stipulated in the Management Law shall be treated as counterfeit drugs according to the law.
The amount of Chinese medicinal materials involved in the case is large, totaling more than 20,000 kilograms. If it enters the market after sales, it may have extensive adverse effects on the lives and health of the people. The investigation and punishment of the law enforcement department is justified, timely and necessary.
Under the background that the country is actively promoting the high-quality development of traditional Chinese medicine and the industry, and promoting the globalization of traditional Chinese medicine, the people's court shall support the lawful investigation and punishment of illegal acts in the field of traditional Chinese medicinal materials by the drug supervision and administration department, so as to maintain the people's medication Safety and health, supervise and promote the healthy development of the Chinese herbal medicine industry.
Case 7: A pharmacy sued the former Chongqing Municipal Food and Drug Administration Wanzhou Branch for administrative penalty
——Supervise and support administrative organs to investigate and punish acts of leasing drug business licenses and selling counterfeit drugs in accordance with the law
brief case
In October 2015, a pharmacy (Party A) and Mr. Lin (Party B) signed a "Pharmacy Contracting Operation Contract", which stipulated that Party A would contract the pharmacy to Party B for management, and that all Party A's pharmacy business licenses, drug business licenses, Qualification certificates such as the certificate of quality management standard for pharmaceutical business shall be provided to Party B for use.
Later, Lin gave the pharmacy to his mother, Cai, to be in charge of the operation.
In October 2017, when the former Chongqing Food and Drug Administration Wanzhou Branch (hereinafter referred to as the Chongqing Food and Drug Administration Wanzhou Branch) conducted an on-site inspection of the pharmacy, it seized 12 boxes of the counterfeit drug "Chuangsuqing TM Ganoderma Lucidum Loquat Capsules".
In December of the same year, the Wanzhou Branch of the Chongqing Food and Drug Administration issued (Wanzhou) Drug Punishment [2017] No. 97 "Decision on Administrative Penalty", confirming that a pharmacy illegally rented out a drug business license and pharmacy operating rights, and provided Cai for selling counterfeit drugs If the place and qualification certificate are obtained, the punishment should be heavier, and a fine of 20,000 yuan was decided, and the drug business license of a pharmacy was revoked.
A pharmacy refused to accept 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.
referee result
After hearing, the court held that a pharmacy leased a drug business license to Lin for operation, which violated Article 12 of the "Administrative Measures for Drug Business Licenses": "The "Pharmaceutical Business License" is the legal certificate for the enterprise to engage in drug business activities. Units and individuals shall not forge, alter, trade, lease and lend”.
Because the mother of the pharmacy contractor Lin Mou, Cai Mou, was investigated and dealt with for selling the counterfeit drug "Chuansuqing TM Ganoderma 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 out a drug business license, and the circumstances were serious. According to Article 81 of the "Pharmaceutical Administration Law of the People's Republic of China (Amended in 2015)", the administrative penalty decision to impose a fine and revoke the drug business license is in line with the law.
The court of first instance ruled in August 2018 to dismiss a pharmacy's claim.
The court of second instance dismissed the appeal in December 2018 and upheld the judgment of first instance.
typical meaning
This case is a typical case in which the people's court supports the drug supervision and administration department to strictly investigate and punish the illegal rental of drug business licenses and the sale of counterfeit drugs.
my country's laws implement a strict licensing management system for pharmaceutical business activities, and it is prohibited to engage in pharmaceutical business activities without obtaining a pharmaceutical business license.
Illegal leasing of drug business licenses, allowing natural persons or organizations without drug business qualifications to obtain drug business qualifications, and providing convenient conditions for the sale of counterfeit and inferior drugs, seriously disrupt the order of drug market business operations, and should be strictly investigated and punished in accordance with the law.
In this case, a pharmacy signed a "Pharmacy Contracting Operation Contract" with others, provided the pharmacy's business license, drug business license and other qualification certificates for others to use, and charged contract fees on a regular basis. It also provides a place and qualification certificate for the actual pharmacy operators to sell counterfeit drugs, jeopardizing the safety of public medication.
The people's court supports the administrative organ to impose a heavier punishment on a pharmacy in accordance with the law, which demonstrates the people's court's determination to support the drug supervision and administration department in the strictest supervision of drug business activities.
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 medication, safeguard the lives and health of the people, and at the same time ensure the orderly operation of the drug market and create a good business environment governed by the rule of law.
Case 8: Dispute over the right to life between Zhong Moumou, Du Moujia, Du Mouyi and a pharmacy and Yuan Moumou
——The method of decoction and precautions should be informed when selling Chinese herbal decoction pieces
brief case
2017年7月6日，杜某某到某药房购买香加皮150克，并于当晚将150克香加皮煎水服用，出现胸闷、恶心、呕吐，被家人送往医院，经抢救无效死亡。市场和质量监督管理部门委托检验机构对涉案的香加皮抽样检验，检验结果为质量合格产品。某司法鉴定研究所出具《尸检鉴定意见书》，证明杜某某符合过量服用香加皮导致中毒致死，为死亡的主要原因；其自身所患冠心病的潜在疾病对死亡起辅助促进作用。杜某某的妻子钟某某，儿子杜某甲、杜某乙以某药房在无执业医师、营业员无上岗证的情况下出售香加皮给杜某某而未告知煎服方法及注意事项导致其中毒死亡为由诉至法院，要求某药房及其股东袁某某承担侵权责任。
裁判结果
法院经审理认为，《中华人民共和国药品管理法(2015年修正)》第十九条规定“药品经营企业销售药品必须准确无误，并正确说明方法、用量和注意事项……”。鉴定报告指出杜某某主要因为过量服用香加皮中毒致死，某药房是香加皮销售方，《药品经营质量管理规范(2016)》第一百六十七条第(四)项规定“销售药品应当符合以下要求：(四)销售中药饮片做到计量准确，并告知煎服用法及注意事项；提供中药饮片代煎服务，应当符合国家有关规定。”某药房在销售香加皮时负有告知杜某某煎服香加皮的方法及注意事项的义务，现有证据不足以证明某药房尽到了告知义务，某药房负有告知义务而未作为，具有过错，构成侵权；本案的损害结果是杜某某的死亡，某药房的过错行为与杜某某的死亡具有因果联系，某药房应当承担过错责任。因杜某某的死亡是药房没有尽到说明告知义务与其自身过错、自身疾病共同导致的，所以药房和杜某某应各承担50%的责任。遂判决：一、某药房赔偿钟某某、杜某甲、杜某乙治疗费1249.5元、丧葬费28735元、死亡赔偿金315403元、鉴定费16000元、其他费用8176元的50%计184781.75元；二、某药房赔偿钟某某、杜某甲、杜某乙精神抚慰金10000元；三、某药房应在判决生效后十日内履行完上述款项赔偿义务；四、驳回钟某某、杜某甲、杜某乙的其他诉讼请求。
典型意义
中药饮片不像西药有明确的说明书，中药饮片的功效、毒性、用量等并不被普通群众所熟知，一旦错误用药极易威胁生命健康安全，引发类似本案的悲剧。销售中药饮片应做到计量精准并告知煎服用法及注意事项。本案判决未尽到告知义务的药房对购买人因过量服用香加皮而导致的死亡承担相应的侵权责任，对销售中药饮片的经营者起到警示作用，警示其充分重视购药者的生命健康安全，在销售中药饮片时应充分尽到告知义务，告知中药饮片的煎服方法及注意事项。
案例九：许某与某药房买卖合同纠纷案
——消毒产品标示治疗功能误导消费者购买构成欺诈
简要案情
许某于2016年6月在某药房先后购买了10盒“步洲”皮康乐制剂，共支付了180元。《“步洲”皮康乐制剂说明书》载明“作用”为抑制、杀灭皮肤真菌、霉菌；“批准文号”为鲁卫消证字(2013)第0029号。“步洲系列产品简介”中“皮康乐”的适用范围：由真菌引起的皮肤感染，如脚气、手癣、头癣、体癣、股癣、白癣、脓癣、黄癣、花斑癣(汗斑)、红癣、念珠菌病及一切真菌性皮肤瘙痒；产品优势：古语“行医不治癣，治癣就丢脸”。步洲牌皮康乐，清除真菌性癣病，效果领先。许某认为该药房以非药品冒充药品向其销售的行为违法，遂诉至法院要求该药房返还购物款并按消费者权益保护法三倍赔偿其损失。
裁判结果
法院经审理认为，经营者向消费者提供有关商品或者服务的质量、性能、用途、有效期限等信息，应当真实、全面，不得作虚假或者引人误解的宣传。涉案产品的批准文号为×卫消证字(20××)第00××号，系消杀用品(消毒产品)，但该产品的说明书、产品简介中均标示其具有治疗真菌性癣病的功效。根据《中华人民共和国药品管理法(2015年修正)》第四十八条“禁止生产(包括配制，下同)、销售假药。有下列情形之一的，为假药：…(二)以非药品冒充药品或者以他种药品冒充此种药品的”的规定，该药房以非药品冒充药品进行销售，致使许某作出错误意思表示，构成欺诈。许某要求该药房返还购物款并按价款的三倍赔偿其损失符合法律规定，法院遂判决该药房返还许某购物款180元并赔偿损失540元。
典型意义
遍布城市大街小巷的药店，为老百姓及时购买药品、消除病痛带来了便利。但一些药品经营企业存在违规宣传销售的消毒、保健品有治疗功能、误导消费者的违法行为，危害人民身体健康。消毒产品不是药，不具备调节人体生理机能的功效，不能用于治疗疾病，与药品有着明显区别。《消毒管理办法》明确规定，消毒产品的标签(含说明书)和宣传内容必须真实，不得出现或暗示对疾病的治疗效果。消费者购买产品时一定要留意产品批准文号，严格区分“国药准字号”和“卫消证字号”产品，不要把消毒产品当药使用，以免延误病情。本案通过认定涉案标示治疗功能的消毒产品为假药、药品经营企业错误引导消费者购药的行为构成欺诈并适用惩罚性赔偿的规定，既能对药品经营企业起到应有的警示作用，规范其经营活动，也有利于引导广大消费者慎重、理性选购治疗性药品，保护消费者的合法权益。
案例十：杨某某诉某药房合同纠纷案
——销售未注明产品批号的药品应承担赔偿责任
简要案情
某药房是经市场监督管理局登记的个体工商户，为个人经营。其经营范围为：处方药与非处方药、抗生素、中成药、化学制剂、保健品、预包装食品销售(依法须经批准项目，经相关部门批准后方可开展经营活动)。2019年6月10日，杨某某到某药房购买“伟哥”，在营业员介绍下购买了“虫草生精胶囊”2大盒，每盒单价500元；“黄金伟哥”1大盒，单价500元；“肾宝片”1大盒，单价500元。合计价款2000元。杨某某现金支付价款后营业员未出具小票，在杨某某的要求下营业员手写了一份购物清单(某药房交款单)并加盖了“某药房现金收讫章”。后杨某某通过国家食品药品监督管理总局官网查询所购“虫草生精胶囊”信息未果，即以所购产品为有毒有害假药为由，提起本案诉讼。
裁判结果
法院经审理认为，本案所涉商品外包装标注了商品功效，其内置说明书明确载明其主要成分、适用人群、用法用量等内容，上述记载均满足了《中华人民共和国药品管理法(2019年修订)》第二条第二款“本法所称药品，是指用于预防、治疗、诊断人的疾病，有目的地调节人的生理机能并规定有适应症或者功能主治、用法和用量的物质，包括中药、化学药和生物制品等”关于药品的定义要件，因此，法院认定本案所涉商品“虫草生精胶囊”“黄金伟哥”“肾宝片”为药品。
Paragraph 1 of Article 98 of the Drug Administration Law of the People's Republic of China (Revised in 2019) stipulates that "the production (including preparation, the same below), sale, and use of counterfeit and inferior medicines is prohibited." Paragraph 3 stipulates that "there are the following In one of the circumstances, it is an inferior drug: (1) The content of the drug ingredients does not meet the national standard; (2) The contaminated drug; (3) The drug whose expiry date is not marked or changed; (4) The product batch number is not marked or changed (5) Medicines that have expired; (6) Medicines with preservatives and excipients added without authorization; (7) Other medicines that do not meet the drug standards.”
Both parties in this case agree that the results of inquiring about "Cordyceps Extract Capsules", "Golden Viagra" and "Shenbao Tablets" on the official website of the State Food and Drug Administration. A pharmacy sold "Cordyceps Extract Capsules" and "Golden Viagra" to Yang Moumou. "Shenbao Tablets" should be identified as inferior drugs if the batch number of the drug product is not indicated.
Yang Moumou's request to order a pharmacy to refund 2,000 yuan of the purchase price and make compensation at ten times the price of the purchase price is in line with the law.
A pharmacy was ordered to compensate Yang Moumou for 2,000 yuan and pay compensation of 20,000 yuan.
typical meaning
Food and drug safety is related to the health and life safety of the people, and the state has always adopted strict control measures.
Paragraph 3 of Article 144 of the Drug Administration Law of the People's Republic of China (Revised in 2019) "If a person who produces counterfeit or inferior drugs, or who knows they are fake or inferior drugs still sells and uses them, the victim or his close relatives shall In addition to the claim for compensation for losses, you can also request to pay ten times the price or three times the loss; if the amount of increased compensation is less than one thousand yuan, it will be one thousand yuan." The newly revised Drug Administration Law enforces stricter regulations on drug safety. Management, increase the amount of compensation for the loss of victims buying counterfeit medicines for the production of fake or inferior medicines, or those who know they are fake or inferior medicines are still sold and used, which is helpful for purifying the drug market and raising the general public's awareness of food and drug safety. , It is of great significance to promote citizens to know the law and abide by the law.