The "Two high Schools" jointly issued the "Interpretation of Several Issues on the Application of Law in Handling Criminal Cases Endangering Drug Safety"

　　The Interpretation of the Supreme People's Court and the Supreme People's Procuratorate on Several Issues concerning the Application of Law in Handling Criminal Cases of Endangering Drug Safety was adopted by the 185th meeting of the Judicial Committee of the Supreme People's Court on February 28, 2022, and by the 92nd meeting of the 13th Procuratorial Committee of the Supreme People's Procuratorate on February 25, 2022，Hereby published，Effective from March 6, 2022。

　                                              　Supreme People's Court

　　                                              Supreme People's Procuratorate

　　                                              March 3, 2022

　　Gao Jian Fangshi No. 1 [2022]

　　Interpretation of the Supreme People's Court and Supreme People's Procuratorate on several issues concerning the application of Law in Handling criminal cases of endangering drug safety

　　(Adopted at the 185th Meeting of the Judicial Committee of the Supreme People's Court on February 28, 2022, and at the 92nd meeting of the 13th Procuratorial Committee of the Supreme People's Procuratorate on February 25, 2022, and effective as of March 6, 2022)

　　To punish crimes against drug safety according to law，To protect people's lives and health，Maintain drug administration order，In accordance with the Criminal Law of the People's Republic of China, the Criminal Procedure Law of the People's Republic of China and the Drug Administration Law of the People's Republic of China and other relevant provisions，A number of issues concerning the application of the law in handling such criminal cases are explained as follows:

　　Article 1 Anyone who produces, sells or provides counterfeit drugs under any of the following circumstances shall be given a heavier punishment as appropriate:

　　(1) The drugs involved are mainly used by pregnant women, children or critically ill patients;

　　(2) The drugs involved are narcotic drugs, psychotropic drugs, toxic drugs for medical use, radiopharmaceuticals, biological products, or precursors of drugs that are passed off as other drugs;

　　(3) The drugs involved are injectable drugs or first-aid drugs;

　　(4) The drugs involved are used to respond to natural disasters, accidents, public health events, social security events and other emergencies;

　　(5) The unit using drugs and its staff producing or selling counterfeit drugs;

　　(6) Other circumstances that should be given a heavier punishment as appropriate。

　　Article 2 The production, sale or supply of counterfeit drugs under any of the following circumstances shall be identified as "causing serious harm to human health" as provided for in Article 141 of the Criminal Law:

　　(1) causing minor or serious injuries;

　　(2) causing mild or moderate disability;

　　(3) causing organ and tissue damage resulting in general or serious dysfunction;

　　(4) other situations that cause serious harm to human health。

　　Article 3 The production, sale or supply of counterfeit drugs under any of the following circumstances shall be identified as "other serious circumstances" as provided for in Article 141 of the Criminal Law:

　　(1) causing a major public health emergency;

　　(2) producing, selling or providing counterfeit drugs for an amount between 200,000 yuan and 500,000 yuan;

　　(3) Producing, selling or providing counterfeit drugs with an amount of not less than 100,000 yuan but not more than 200,000 yuan, and under any of the circumstances specified in Article 1 of this Interpretation;

　　(4) According to the production, sale, supply of time, quantity, type of counterfeit drugs, the degree of harm to human health, etc., should be identified as serious circumstances。

　　Article 4 The production, sale or supply of counterfeit drugs under any of the following circumstances shall be identified as "other particularly serious circumstances" as provided for in Article 141 of the Criminal Law:

　　(1) causing severe disability or more;

　　(2) causing serious injury or moderate disability to three or more people or organ and tissue damage resulting in serious dysfunction;

　　(3) causing five or more people to be mildly disabled or organ and tissue damage resulting in general dysfunction;

　　(4) causing minor injuries to ten or more persons;

　　(5) causing a major or especially major public health emergency;

　　(6) producing, selling or providing counterfeit drugs for an amount of 500,000 yuan or more;

　　(7) Producing, selling or providing counterfeit drugs with an amount between 200,000 yuan and 500,000 yuan, and under any of the circumstances specified in Article 1 of this Interpretation;

　　(8) According to the production, sale, supply of time, quantity, type of counterfeit drugs, the degree of harm to human health, etc., should be identified as particularly serious circumstances。

　　Article 5 Anyone who produces, sells or provides substandard drugs under any of the circumstances specified in Article 1 of this Interpretation shall be given a heavier punishment as appropriate。

　　The production, sale or supply of inferior drugs, which has one of the circumstances specified in Article 2 of this interpretation, shall be identified as "causing serious harm to human health" as stipulated in Article 142 of the Criminal Law.。

　　The production, sale or supply of substandard drugs, resulting in death, or having one of the circumstances provided for in items 1 to 5 of Article 4 of this interpretation, shall be identified as "particularly serious consequences" as provided for in Article 142 of the Criminal Law.。

　　Article 6 For the purpose of producing, selling or providing counterfeit or substandard drugs，Synthesize, refine, extract, store, process and process pharmaceutical raw materials，Or in the process of making pharmaceutical raw materials, auxiliary materials, and packaging materials into finished products，Dispensing, mixing, preparation, storage or packaging，It shall be identified as "production" as provided for in Articles 141 and 142 of the Criminal Law.。

　　A drug user and its staff members knowingly provide fake or substandard drugs to others for use with compensation，It shall be identified as "sales" as provided for in Articles 141 and 142 of the Criminal Law;Made available to others without charge，It shall be identified as "provision" as provided in Articles 141 and 142 of the Criminal Law.。

　　Article 7 Any act that impinges on drug administration under any of the following circumstances shall be identified as "enough to seriously endanger human health" as provided for in Article 142 of the Criminal Law:

　　(1) producing or selling a drug whose use is prohibited by the drug regulatory department under The State Council, and considering the circumstances such as the time, quantity and reasons for the prohibition, it is considered that the drug poses a real danger of serious harm to human health;

　　(2) Producing drugs without obtaining relevant approval documents for drugs or knowingly selling the above-mentioned drugs, and the drugs involved fall under the circumstances specified in Items 1 to 3 of Article 1 of this Interpretation;

　　(3) Producing drugs without obtaining the relevant approval documents of drugs or knowingly selling the above-mentioned drugs, and the indications, functional indications or ingredients of the drugs involved are unknown;

　　(4) Producing drugs without obtaining relevant approval documents for drugs or knowingly selling the above-mentioned drugs, and the drugs involved have no national drug standards and no approved drug quality standards, but chemical ingredients are detected;

　　(5) Importing drugs without obtaining relevant approval documents for drugs or knowingly selling the above drugs, and the drugs involved are not legally listed abroad;

　　(6) Deliberately using false investigational drugs in non-clinical research or clinical trials of drugs, or concealing serious adverse events related to drugs used in clinical trials;

　　(7) Intentionally destroying the original drug non-clinical research data or drug clinical trial data，Or fabricate test animal information, subject information, main test process records, research data, detection data and other drug non-clinical research data or drug clinical trial data，Affecting the safety, effectiveness or quality control of the drug;

　　(8) fabricating production or testing records, affecting the safety, effectiveness and quality control of drugs;

　　(9) other situations that are sufficient to seriously endanger human health。

　　For whether the drug involved is legally listed overseas, it shall be determined according to law based on evidence such as the certificate of the overseas drug regulatory department or the right holder, combined with the comprehensive examination of the evidence materials provided by the criminal suspect, defendant and their defenders。

　　For "enough to seriously harm human health" is difficult to determine, according to the identification opinion issued by the drug regulatory department at or above the municipal level, combined with other evidence to make a determination。

　　Article 8 An act that interferes with drug administration and has one of the circumstances provided for in Article 2 of this interpretation shall be identified as "causing serious harm to human health" as stipulated in Article 142 of the Criminal Law。

　　If an act that interferes with drug administration is enough to seriously endanger human health, and has any of the following circumstances, it shall be identified as "other serious circumstances" as provided for in Article 142 of the Criminal Law:

　　(1) producing or selling a drug whose use is prohibited by the drug regulatory department under The State Council, for an amount of 500,000 yuan or more;

　　(2) producing or importing drugs without obtaining relevant approval documents for drugs, or knowingly selling the said drugs, producing or selling more than 500,000 yuan;

　　(3) providing false certificates, data, materials or samples or taking other deceptive means in the application for drug registration, resulting in serious consequences;

　　(4) fabricating production or inspection records, causing serious consequences;

　　(5) Situations that cause adverse social impact or have other serious circumstances。

　　Whoever commits an act as provided for in Article 142 of the Criminal Law and at the same time constitutes the crime of producing, selling or providing counterfeit drugs, the crime of producing, selling or providing substandard drugs or any other crime, shall be convicted and punished in accordance with the provisions for a heavier punishment。

　　Article 9 A person who knowingly commits a crime endangering drug safety and has any of the following circumstances shall be regarded as a joint crime:

　　(1) Providing funds, loans, account numbers, invoices, certificates, licenses;

　　(2) providing facilities for production or business operation, equipment, or transportation, storage, custody, mailing, sales channels, etc.;

　　(3) providing production technology or raw materials, auxiliary materials, packaging materials, labels or instructions;

　　(4) Providing false drug non-clinical research reports, drug clinical trial reports and related materials;

　　(5) providing advertising;

　　(6) providing other assistance。

　　Article 10 Criminal cases involving the production, sale and provision of fake drugs, the production, sale and provision of substandard drugs, and the obstruction of drug administration shall be handled，The subjective intention of the actor should be determined by combining the facts of the actor's working experience, cognitive ability, drug quality, purchase channels and prices, sales channels and prices, production and sales methods, etc。Under any of the following circumstances, it can be determined that the perpetrator has the subjective intention to commit the relevant crime, except that there is evidence to prove that there is no intention:

　　(1) the price of the drug is obviously different from the market price;

　　(2) Purchasing drugs from unqualified producers and sellers, and failing to provide legal and valid proof of origin;

　　(3) evading or resisting supervision and inspection;

　　(4) transferring, concealing or destroying records of drugs and goods purchased and sold in the case;

　　(5) Having been punished for committing illegal and criminal acts endangering drug safety, and committing similar acts again;

　　(6) other circumstances sufficient to determine the subjective intent of the perpetrator。

　　Article 11 For the purpose of providing drugs to others for production, sale or supply，Violate state regulations，Production and sales of raw materials and auxiliary materials that do not meet the requirements of medicine，In accordance with the provisions of Article 140 of the Criminal Law，To be given a heavier punishment for the crime of producing or selling fake or inferior products;Those that concurrently constitute other crimes，Be convicted and punished in accordance with the provisions for heavier punishment。

　　Article 12 An advertiser, advertising agent or advertisement publisher who, in violation of State regulations, falsely advertises a drug through advertisement, if the circumstances are serious, shall be convicted and punished for the crime of false advertisement in accordance with the provisions of Article 222 of the Criminal Law。

　　Article 13 Illegal purchase or sale of drugs that are knowingly purchased using medical insurance fraud，The amount is more than 50,000 yuan，The provisions of Article 312 of the Criminal Law shall be followed，Be convicted and punished for covering up or concealing the offence committed;Instigating, abetting or instructing others to use medical insurance to fraudulently purchase drugs，And then illegally buy, sell，In accordance with the provisions of Article 266 of the Criminal Law，Be convicted and punished for fraud。

　　Whether the perpetrator who uses medical insurance to defraud insurance to buy drugs should be investigated for criminal responsibility should be integrated with the specific circumstances of the case such as the amount, means, confession and repentance attitude of the medical insurance fund, and be properly decided according to law。Whether the perpetrator who uses medical insurance to defraud insurance to buy drugs is investigated for criminal responsibility does not affect the conviction and punishment of the perpetrator who illegally buys and sells the relevant drugs。

　　Subjective knowledge as provided for in paragraph 1 shall be determined on the basis of drug labeling, acquisition channels, price, scale and drug traceability information。

　　Article 14 Where a state organ functionally responsible for drug safety supervision and administration abuses its power or neglects its duty, constituting a crime of dereliction of duty in drug supervision, and constituting a crime of malfeasance in commodity inspection, such as a crime of favoritism, a crime of dereliction of duty in commodity inspection, etc., it shall be convicted and punished in accordance with the provisions of heavier punishment。

　　Where a functionary of a state organ responsible for drug safety supervision and administration abuses his power or neglects his duty, which does not constitute a crime of dereliction of duty in drug control, but constitutes other crimes of dereliction of duty as provided for in the preceding paragraph, he shall be convicted and punished according to the other crimes。

　　Any functionary of a state organ responsible for the supervision and administration of drug safety who colludes with others, takes advantage of his position to help others commit criminal acts endangering drug safety, and at the same time constitutes a crime of dereliction of duty or an accomplice in the crime of endangering drug safety, shall be convicted and given a heavier punishment in accordance with the provisions for heavier punishment。

　　Article 15 Where a person commits the crime of producing, selling or providing counterfeit drugs, producing, selling or providing substandard drugs, or interfering with drug administration, a fine shall be imposed according to law, taking into account the amount of the defendant's crime and his illegal income, taking into account the defendant's ability to pay the fine。The fine shall generally be more than twice the amount of the drug produced, sold or supplied;Where a joint crime is committed, the total fine imposed on each joint criminal shall generally be more than twice the amount of the drug produced, sold or provided。

　　Article 16 Anyone who commits the crime of producing, selling or providing counterfeit drugs, of producing, selling or providing substandard drugs, or of interfering with drug control shall be strictly suspended and exempted from the application of criminal punishment in accordance with the conditions stipulated in the criminal Law。If he is sentenced to criminal punishment, he may, according to the circumstances of the crime and the need to prevent another crime, declare a professional prohibition or prohibition order according to law。Where the Drug Administration Law of the People's Republic of China and other laws and administrative regulations provide otherwise, such provisions shall prevail。

　　Where an offender who is not prosecuted or exempted from criminal punishment needs to be given administrative, administrative or other sanctions, the offender shall be transferred to the competent authority for handling according to law。

　　Article 17 Where a unit commits the crime of producing, selling or providing counterfeit drugs, the crime of producing, selling or providing substandard drugs, or the crime of interfering with drug administration, it shall be fined, and the persons directly in charge and other persons directly responsible shall be punished in accordance with the conviction and sentencing standards for crimes committed by natural persons as provided for in this Interpretation。

　　Where a unit commits a crime, the total fine imposed on the defendant unit, its directly responsible persons in charge and other directly responsible persons shall generally be more than twice the amount of the drug produced, sold or provided。

　　Article 18 Where drugs are processed or sold in small quantities on the basis of traditional folk formulations without causing harm to others or delaying diagnosis and treatment, or where the production, import or sale of drugs with the nature of self-help or mutual assistance is carried out for non-profit-making purposes, it shall not be identified as a crime。

　　It is difficult to determine whether it is a folk traditional formula, according to the identification opinions issued by the drug regulatory department at or above the municipal level or relevant departments, combined with other evidence to make a determination。

　　Article 19 "Fake drugs" and "substandard drugs" as provided for in Articles 141 and 142 of the Criminal Law shall be identified in accordance with the provisions of the Drug Administration Law of the People's Republic of China。

　　Counterfeit and substandard drugs prescribed in Article 98 (2) (2), (4) and (3) (3-6) of the Drug Administration Law of the People's Republic of China，Can according to the site seized raw materials, packaging，Judgments are made on the basis of evidentiary materials such as the confessions of criminal suspects and defendants，It may be issued by the drug regulatory department at or above the municipal level。In accordance with the provisions of the second and third paragraphs of Article 98 of the Drug Administration Law of the People's Republic of China, counterfeit and substandard drugs are identified，Or whether it belongs to the counterfeit or substandard drugs stipulated in Article 98, paragraph 2, Paragraph 2, and paragraph 3, paragraph 6, there is a dispute，The inspection shall be conducted by a drug testing institution established or determined by the drug regulatory department at or above the provincial level，Issue quality inspection conclusion。The judicial organ shall make the determination based on the determination opinion, the test conclusion and other evidence。

　　Article 20 The amount of money for the production or supply of drugs shall be calculated on the basis of the value of the drugs.The amount of drug sales shall be calculated on the basis of income and all illegal income available。

　　Article 21 This interpretation shall come into force on March 6, 2022。After the promulgation of this interpretation，The Interpretations of the Supreme People's Court and the Supreme People's Procuratorate on Several Issues concerning the Application of Law in Handling Criminal Cases of endangering drug Safety (Legal Interpretation (2014) No. 14), and the Interpretations of the Supreme People's Court and the Supreme People's Procuratorate on Several Issues concerning the application of Law in Handling Criminal cases of Falsification of application materials for registration of drugs and medical Devices (Legal Interpretation (2017) No. 15)annul。