Legal subjectivity:
The legal liability for producing and selling inferior drugs is administrative liability and criminal liability. Article 117 of the "Drug Administration Law": Whoever produces or sells inferior drugs shall have the illegally produced and sold drugs and illegal income confiscated, and shall be fined not less than ten times but not more than twenty times the value of the illegally produced and sold drugs. Fines; if the value of drugs illegally produced or wholesaled is less than 100,000 yuan, it will be calculated as 100,000 yuan; if the value of illegally retailed drugs is less than 10,000 yuan, it will be calculated as 10,000 yuan; if the circumstances are serious, it will be ordered to suspend production and business for rectification. Until the drug approval document, drug production license, drug business license or medical institution preparation license is revoked. Article 142 of the Criminal Law: Whoever produces or sells inferior drugs that causes serious harm to human health shall be sentenced to a fixed-term imprisonment of not less than three years but not more than ten years, and a fine of not less than 50% but not more than twice the amount of sales; If the consequences are particularly serious, he shall be sentenced to fixed-term imprisonment of not less than ten years or life imprisonment, and shall also be fined not less than 50% but not more than twice the sales amount, or his property shall be confiscated. The term "substandard drugs" as mentioned in this article refers to drugs that are inferior drugs in accordance with the provisions of the "Drug Administration Law of the People's Republic of China". The law is objective:
[Criminal Law Articles] Article 141 Whoever produces or sells counterfeit medicines shall be sentenced to fixed-term imprisonment of not more than three years or criminal detention, and shall also be fined; if it causes serious harm to human health or has other If the circumstances are serious, the person shall be sentenced to fixed-term imprisonment of not less than three years and not more than ten years, and shall also be fined; if the crime causes death or there are other particularly serious circumstances, the person shall be sentenced to fixed-term imprisonment of not less than ten years, life imprisonment, or death, and shall also be fined or have property confiscated. The term "counterfeit drugs" as mentioned in this article refers to drugs and non-drugs that are counterfeit drugs and treated as counterfeit drugs in accordance with the provisions of the "Drug Administration Law of the People's Republic of China". Article 149 The production and sale of the products listed in Articles 141 to 148 of this section does not constitute a crime stipulated in the respective articles, but if the sales amount exceeds 50,000 yuan, Convicted and punished in accordance with the provisions of Article 140 of this Section. Aggravating circumstances: Producing and selling the products listed in Articles 141 to 148 of this section constitutes the crime stipulated in each of those articles, and at the same time constitutes the crime stipulated in Article 140 of this section. , convicted and punished in accordance with the provisions of heavier penalties. Article 150 If a unit commits the crimes stipulated in Articles 140 to 148 of this section, the unit shall be fined, and the persons directly in charge and other directly responsible persons shall be fined in accordance with the respective regulations. The penalties specified in this article. Judicial Interpretation of the Supreme People's Procuratorate and the Ministry of Public Security's "Regulations on the Standards for Filing and Prosecution of Criminal Cases under the Jurisdiction of Public Security Organs (I)" (Gongtongzi [2008] No. 36) Article 17 [Case of Producing and Selling Counterfeit Drugs (Criminal Law No. 1) Article 141)] Production (including preparation) and sale of counterfeit drugs, if suspected of any of the following circumstances, shall be investigated and prosecuted: (1) Containing toxic and harmful substances exceeding the standard; (2) Containing no effective ingredients as indicated Ingredients, which may delay diagnosis and treatment; (3) The indicated indications or functions are beyond the prescribed scope, which may cause delay in diagnosis and treatment; (4) Lack of effective ingredients necessary for first aid as indicated; (5) Other substances that can seriously harm the human body health or causing serious harm to human health. The "counterfeit drugs" specified in this article refer to drugs and non-drugs that are counterfeit drugs and treated as counterfeit drugs in accordance with the provisions of the "Drug Administration Law of the People's Republic of China". The Supreme People's Procuratorate and the Ministry of Public Security's "Supplementary Provisions on the Standards for Filing and Prosecution of Criminal Cases under the Jurisdiction of Public Security Organs (I)" Gongtongzi [2017] No. 12 2. Modify Article 17 of the "Standards for Filing and Prosecution (I)" Those who produce and sell counterfeit drugs for: [Case of Producing and Selling Counterfeit Drugs (Criminal Law Article 141)] shall be prosecuted. However, sales of a small amount of drugs that are privately processed according to traditional folk formulas, or sales of a small amount of foreign or overseas drugs imported without approval, without causing harm to others or delaying diagnosis and treatment, except for cases where the circumstances are obvious and minor and the harm is not great. For the purpose of producing and selling counterfeit drugs, any of the following circumstances falls under the "production" stipulated in this article: 1. Synthesizing, refining, extracting, storing, processing and concocting pharmaceutical raw materials; (2) Converting pharmaceutical raw materials, excipients, packaging In the process of making materials into finished products, batching, mixing, preparation, storage, and packaging are carried out; (3) Packaging materials, labels, and instructions are printed.
Medical institutions or medical institution staff who knowingly provide counterfeit medicines to others for a fee, or purchase or store medicines for sale, fall under the “sale” provisions of this article. The "counterfeit drugs" specified in this article refer to drugs and non-drugs that are counterfeit drugs and treated as counterfeit drugs in accordance with the provisions of the "Drug Administration Law of the People's Republic of China". If it is difficult to determine whether a drug is counterfeit, it can be determined based on the identification opinions issued by the drug supervision and administration department at or above the prefecture-level city and other relevant materials. When necessary, a drug inspection agency set up or determined by the drug regulatory department at or above the provincial level may be entrusted to conduct inspection. The Supreme People's Court and the Supreme People's Procuratorate's "Interpretation on Several Issues Concerning the Application of Laws in Handling Criminal Cases Endangering Drug Safety" Fa Interpretation [2014] No. 14 (1626th Meeting of the Judicial Committee of the Supreme People's Court on September 22, 2014, March 2014 Adopted at the 18th meeting of the 12th Procuratorial Committee of the Supreme People's Procuratorate on the 17th) In order to punish crimes endangering drug safety in accordance with the law, protect the lives, health and safety of the people, and maintain the order of the drug market, in accordance with the provisions of the "People's Republic of China and the Criminal Law of the People's Republic of China" , several issues concerning the application of laws in handling such criminal cases are explained as follows: Article 1 Whoever produces or sells counterfeit medicines under any of the following circumstances shall be severely punished as appropriate: (1) The counterfeit medicines produced or sold are for pregnant women, Infants, children or critically ill patients are the main targets of use; (2) The counterfeit drugs produced and sold are narcotic drugs, psychotropic drugs, medical toxic drugs, radioactive drugs, contraceptives, blood products, and vaccines; (3) Production , The counterfeit drugs sold are injection drugs and emergency drugs; (4) Medical institutions and staff of medical institutions produce and sell counterfeit drugs; (5) In the event of natural disasters, accidents, public health incidents, and social security incidents During such emergencies, those who produce and sell counterfeit medicines to deal with emergencies; (6) Those who have received administrative or criminal penalties for illegal and criminal activities endangering drug safety within two years; (7) Others who should be severely punished as appropriate. situation. Article 2 Anyone who produces or sells counterfeit drugs under any of the following circumstances shall be deemed to have "caused serious harm to human health" as stipulated in Article 141 of the Criminal Law: (1) Causing minor or serious injuries; (2) ) causing mild disability or moderate disability; (3) causing damage to organs and tissues leading to general dysfunction or severe dysfunction; (4) other situations that cause serious harm to human health. Article 3 Whoever produces or sells counterfeit drugs under any of the following circumstances shall be deemed as “other serious circumstances” stipulated in Article 141 of the Criminal Law: (1) Causing a major public health emergency ; (2) The production and sales amount is more than 200,000 yuan but less than 500,000 yuan; (3) The production and sales amount is more than 100,000 yuan but less than 200,000 yuan, and one of the circumstances specified in Article 1 of this Interpretation occurs; (4) The circumstances should be determined to be serious based on the time, quantity, type of counterfeit medicine, etc. of production and sales. Article 4 Producing and selling counterfeit drugs under any of the following circumstances shall be deemed as "other particularly serious circumstances" stipulated in Article 141 of the Criminal Law: (1) causing severe disability; (2) causing three Seriously injured, moderately disabled, or damaged organs and tissues resulting in serious functional impairment for more than five people; (3) Causing mild disability to more than five people, or causing general functional impairment due to organ and tissue damage; (4) Slightly injured more than ten people; (5) ) causing major or particularly major public health emergencies; (6) The production and sales amount exceeds 500,000 yuan; (7) The production and sales amount exceeds 200,000 yuan but less than 500,000 yuan, and has One of the circumstances specified in Article 1 of this Interpretation; (8) The circumstances should be determined to be particularly serious based on the time, quantity, type of counterfeit medicine, etc. of production and sales. Article 5: Producing and selling inferior drugs that fall under any of the circumstances specified in Article 2 of this Interpretation shall be deemed to “cause serious harm to human health” as stipulated in Article 142 of the Criminal Law. Producing and selling inferior drugs that cause death, or falling under any of the circumstances specified in Article 4, Paragraph 1 to Paragraph 5 of this Interpretation, shall be deemed to have "particularly serious consequences" as stipulated in Article 142 of the Criminal Law. Anyone who produces or sells inferior drugs and falls under any of the circumstances specified in Article 1 of this Interpretation shall be severely punished as appropriate.
Article 6 Anyone who commits any of the following acts for the purpose of producing or selling counterfeit or inferior drugs shall be deemed to be “production” as stipulated in Articles 141 and 142 of the Criminal Law: (1) The act of synthesizing, refining, extracting, storing, and processing pharmaceutical raw materials; (2) The act of batching, mixing, preparing, storing, and packaging pharmaceutical raw materials, excipients, and packaging materials into finished products; (3) Printing Behavior of packaging materials, labels, instructions. The behavior of medical institutions and medical institution staff who knowingly provide counterfeit or inferior drugs to others for a fee, or purchase or store them for sale, shall be deemed as Article 141 and 142 of the Criminal Law. "Sale" as provided. Article 7 Anyone who violates national drug management laws and regulations, fails to obtain or uses a forged or altered drug business license, and illegally sells drugs, if the circumstances are serious, shall be convicted and punished for the crime of illegal business in accordance with the provisions of Article 225 of the Criminal Law. Anyone who violates state regulations and produces or sells non-pharmaceutical raw materials and excipients that do not meet medicinal requirements for the purpose of providing others with drugs for production and sale, if the circumstances are serious, will be convicted of illegal business operations in accordance with the provisions of Article 225 of the Criminal Law. punishment. Anyone who commits the acts in the preceding two paragraphs and the amount of illegal business operations is more than 100,000 yuan, or the amount of illegal gains is more than 50,000 yuan, shall be deemed to be a "serious case" as stipulated in Article 225 of the Criminal Law; the amount of illegal business operations is more than 50,000 yuan. If the amount exceeds 10,000 yuan, or the amount of illegal income exceeds 250,000 yuan, it shall be deemed as “particularly serious circumstances” as stipulated in Article 225 of the Criminal Law. If the conduct in paragraph 2 of this article is committed and at the same time constitutes the crime of producing and selling counterfeit and inferior products, the crime of endangering public safety by dangerous methods, etc., he shall be convicted and punished in accordance with the provisions of heavier penalties. Article 8 Anyone who knowingly knows that others are producing and selling counterfeit or substandard medicines and commits any of the following circumstances shall be punished with the same crime: (1) Providing funds, loans, account numbers, invoices, certificates, and licenses; (2) ) Providing production, business premises, equipment or transportation, storage, custody, mailing, online sales channels and other convenient conditions; (3) Providing production technology or raw materials, auxiliary materials, packaging materials, labels, instructions; (4) Providing advertising and publicity Waiting for helping behavior. Article 9: Advertisers, advertising operators, and advertising publishers violate national regulations and use advertisements to falsely promote drugs. If the circumstances are serious, they shall be convicted and punished for the crime of false advertising in accordance with the provisions of Article 222 of the Criminal Law. Article 10 Whoever commits the crime of producing and selling counterfeit or substandard drugs, which simultaneously constitutes crimes such as producing and selling counterfeit and substandard products, infringing on intellectual property rights, illegal business operations, illegal medical practice, illegal blood collection and supply, shall be convicted and punished in accordance with the provisions on heavier penalties. Article 11 Criminals who commit crimes stipulated in this interpretation shall be strictly suspended and exempted from criminal punishment in accordance with the conditions stipulated in the criminal law. For those who are subject to probation, a prohibition order shall be issued at the same time to prohibit criminals from engaging in drug production, sales and related activities during the probation period. Selling a small amount of drugs processed privately based on traditional folk formulas, or selling a small amount of foreign or overseas drugs imported without approval, without causing harm to others or delaying diagnosis and treatment, and the circumstances are obvious, minor, and harmless, will not be considered a crime. Article 12 Anyone who commits the crime of producing or selling counterfeit drugs shall generally be sentenced to a fine of more than twice the amount of production or sales in accordance with the law. If the perpetrators commit the same crime, the total fine imposed on the perpetrators shall be more than twice the amount of production and sales. Article 13 If a unit commits a crime stipulated in this Interpretation, the unit shall be fined, and the directly responsible person in charge and other directly responsible personnel shall be punished in accordance with the conviction and sentencing standards for natural person crimes stipulated in this Interpretation. Article 14 If it is difficult to determine whether it is a "fake drug" or "inferior drug" as stipulated in Articles 141 and 142 of the Criminal Law, the judicial authority may make a determination based on the determination issued by the drug regulatory department at or above the prefectural or municipal level. Opinions and other relevant materials for identification. When necessary, a drug inspection agency set up or determined by the drug regulatory department at or above the provincial level may be entrusted to conduct inspection. Article 15 The term “production and sales amount” as mentioned in this Interpretation refers to the income from the production and sale of counterfeit and substandard drugs and all illegal income available. Article 16 The "minor injuries" and "serious injuries" specified in this interpretation shall be evaluated in accordance with the "Standards for Appraisal of Human Body Injury Degrees". The "mild disability", "moderate disability" and "severe disability" specified in this interpretation shall be assessed in accordance with the relevant disability grade assessment standards.
Article 17 After this interpretation is promulgated and comes into effect, the "Interpretation of the Supreme People's Court and the Supreme People's Procuratorate on Several Issues Concerning the Specific Application of Law in Handling Criminal Cases of Producing and Selling Counterfeit and Substandard Drugs" (Fa Interpretation [2009] No. 9) will be abolished at the same time; If previously issued judicial interpretations and normative documents are inconsistent with this interpretation, this interpretation shall prevail. The Supreme People's Court and the Supreme People's Procuratorate's "Interpretations on Several Issues Concerning the Specific Application of Laws in the Handling of Criminal Cases for the Production and Sale of Counterfeit and Substandard Products" (has expired) Article 3 After the appraisal by a drug inspection agency established or determined by the drug regulatory department at or above the provincial level, the production If the counterfeit medicine sold has any of the following circumstances, it shall be deemed to be "sufficient to seriously endanger human health" as stipulated in Article 141 of the Criminal Law: (1) Containing toxic and harmful substances exceeding the standard; (2) Containing no The marked active ingredients may delay diagnosis and treatment; (3) The indicated indications or functional indications are beyond the prescribed scope, which may cause delays in diagnosis and treatment; (4) The marked effective ingredients necessary for first aid are lacking. If the counterfeit drugs produced and sold are used and cause minor injuries, serious injuries or other serious consequences, they shall be deemed to have "caused serious harm to human health." If the counterfeit medicines produced and sold are used, causing serious disability, serious injuries to three people, minor injuries to more than ten people, or other particularly serious consequences, they should be deemed to have "caused particularly serious harm to human health." Article 9 Knows or should know that others are committing the crime of producing or selling counterfeit and inferior goods, and provides them with loans, funds, account numbers, invoices, certificates, licenses, or provides production and business premises or convenient conditions for transportation, warehousing, storage, mailing, etc. , or providing counterfeit production technology, will be punished as a criminal who commits the crime of producing and selling fake and inferior goods. Article 10 If the crime of producing or selling counterfeit and inferior goods is committed, and it also constitutes other crimes such as infringement of intellectual property rights, illegal business operations, etc., the person shall be convicted and punished in accordance with the provisions of heavier penalties. Article 11 Whoever commits a crime stipulated in Articles 140 to 148 of the Criminal Law and resists investigation and punishment by means of violence or threats, thereby constituting other crimes, shall be punished in accordance with the provisions of concurrent punishment for multiple crimes. Article 12 Any state agency staff member who participates in the crime of producing or selling counterfeit and inferior goods shall be severely punished. If this crime also constitutes the "crime of producing and selling counterfeit and inferior products" in Article 140, he will be convicted and punished in accordance with the provisions of heavier penalties. (Criminal Law, Article 149, Paragraph 2)