(1) Drugs whose production and sale are prohibited by the drug supervision and administration department of the State Council;
(2) Producing, importing or knowingly selling drugs without obtaining the approval documents of drugs;
(3) Providing false certificates, data, materials and samples in the application for drug registration or adopting other deceptive means;
(4) fabricating production and inspection records.
Whoever commits the acts mentioned in the preceding paragraph and at the same time constitutes a crime as stipulated in Articles 141 and 142 of the Cost Law or other crimes shall be convicted and punished in accordance with the provisions of heavier punishment.
(A) the concept and elements of the crime of obstructing drug administration
The crime of obstructing drug administration refers to the act of violating drug administration regulations and causing serious harm to human health.
This crime is a new charge in Article 7 of the Criminal Law Amendment (11).
The constitutive elements of the crime of obstructing drug administration are:
1. The object of this crime is the drug management system and personal health and safety.
2. The objective aspect of this crime is the specific circumstances of violating drug administration regulations, which is enough to seriously endanger human health. This kind of crime is a dangerous crime.
Violation of drug administration laws and regulations, including violation of the Drug Administration Law, the Law of Traditional Chinese Medicine, the Regulations for the Implementation of the Drug Administration Law and other relevant laws and administrative regulations on drug supervision.
The Drug Administration Law has provisions on administrative penalties for the four statutory cases of violation of drug administration stipulated in this crime. Whether it constitutes a crime depends on whether it reaches the level of "seriously endangering human health". In this regard, the Interpretation of the Supreme People's Court and the Supreme People's Procuratorate on Several Issues Concerning the Application of Laws in Handling Criminal Cases Endangering Drug Safety (hereinafter referred to as "Interpretation of Handling Criminal Cases Endangering Drug Safety") clearly defines the identification criteria. According to Article 7 of the Interpretation on Handling Criminal Cases Endangering Drug Safety, it shall be deemed as "enough to seriously endanger human health" as stipulated in Article 142 of the Criminal Law: (1) the production and sale of drugs prohibited by the drug supervision and administration department of the State Council, the comprehensive production, sales time, quantity and prohibited use, and (2) the failure to obtain drugs. (3) Producing drugs without obtaining the relevant approval documents, or selling them knowingly, and the indications, functional indications or components of the drugs involved are unknown; (four) without obtaining the relevant approval documents of drugs, producing or selling drugs that are known to be the above drugs, and the drugs involved have no national drug standards or approved drug quality standards, but the drugs with chemical components are detected; (5) importing drugs without obtaining the relevant approval documents for drugs or selling them knowing that they are drugs, and the drugs involved are not legally listed abroad. Whether the drugs involved are legally listed abroad shall be determined according to the evidence provided by the overseas drug supervision and administration department or the obligee, combined with the evidence provided by the criminal suspect, defendant and their defenders. (6) Deliberately using false experimental drugs or concealing serious adverse events related to drugs used in clinical trials during non-clinical research or clinical trials of drugs; (7) Deliberately destroying the original drug non-clinical research data or drug clinical trial data, or fabricating animal information, subject information, main test process records, research data, test data and other drug non-clinical research data or drug clinical trial data, which affects the safety, effectiveness and quality controllability of drugs; (8) fabricating production and inspection records, which affects the safety, effectiveness and controllable quality of drugs; (9) Other circumstances that seriously endanger human health. The situations specified in Item 1 to Item 3 of Article 1 of the Interpretation of Handling Criminal Cases Endangering Drug Safety refer to: (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, radioactive drugs, biological products or counterfeit precursor chemicals of other drugs; (3) The drugs involved are injection drugs and emergency drugs.
According to the provisions of the Interpretation of Handling Criminal Cases Endangering Drug Safety, if it is difficult to determine that it is "enough to seriously endanger human health", it should be determined according to the expert opinions and other evidence issued by the drug supervision and administration department at or above the municipal level.
3. The subject of crime is the general subject. It can be a natural person or a unit.
4. The subjective aspect of crime is intention, and negligence cannot constitute this crime.
(two) the problems that should be paid attention to in determining the crime of obstructing drug management.
When the Drug Administration Law of 20 19 was revised, the scope of counterfeit drugs and inferior drugs stipulated in the Drug Administration Law of 20 15 was greatly adjusted according to the efficacy of drugs, and the original theory of counterfeit drugs and inferior drugs was changed into two categories of counterfeit drugs and inferior drugs, and the concepts of counterfeit drugs and inferior drugs were no longer retained. According to Article 12 1 of the Drug Administration Law, the written decision on punishment of counterfeit and inferior drugs shall specify the quality inspection conclusion of the drug inspection institution according to law. Therefore, in principle, the identification of counterfeit drugs and inferior drugs must be proved by the quality of drugs, and it is no longer directly identified by legal fiction. However, in the original regulations, the production and sale of counterfeit drugs and inferior drugs were treated as crimes. For example, the third paragraph of Article 48 of the Drug Administration Law of 20 15 stipulates that counterfeit drugs should be treated separately according to specific conditions: some of them should be treated as this crime, corresponding to item 1 of this crime, "producing and selling drugs prohibited from being sold by the drug supervision and administration department of the State Council". In other cases, it was originally stipulated that the third drug deteriorated and the fourth drug was contaminated by counterfeit drugs, and the charges were determined according to the conclusion of drug quality inspection and the degree of social harm, which may constitute the crime of producing counterfeit drugs, producing inferior drugs, or just as administrative punishment.
In addition, Article 7 1 of the Interpretation of the Supreme People's Court and the Supreme People's Procuratorate on Several Issues Concerning the Application of Laws in Handling Criminal Cases Endangering Drug Safety (invalid, hereinafter referred to as 20 14 Interpretation of Handling Criminal Cases Endangering Drug Safety) stipulates: "Violating the laws and regulations of the state on drug administration, illegally handling drugs without obtaining or using a forged or altered Drug Business License, and the circumstances are serious. According to the revised Drug Administration Law of 20 19, it is generally believed that the act of producing or importing drugs without obtaining the drug approval certificate can be regarded as the crime of illegal business operation, and the act of producing or importing drugs according to the drug approval certificate can seriously endanger human health, which constitutes this crime. This view imposes a felony on simple business behavior, convicts and punishes illegal business behavior, and imposes a misdemeanor on behavior with specific risks, which obviously leads to unbalanced sentencing. Therefore, after the implementation of the criminal law amendment (11), such situations should not be punished as illegal business operations. Based on this consideration, Article 7 of the Interpretation of Handling Criminal Cases Endangering Drug Safety (20 14) is deleted from the Interpretation of Handling Criminal Cases Endangering Drug Safety, that is to say, the act of dealing in genuine drugs without a license or relying on it should not be punished as illegal business. The responsible comrades in the Supreme People's Court believe that the act of dealing in genuine drugs without a license can be given corresponding administrative punishment, and the crime of illegal business operation should not be applied. Those who constitute other crimes shall be convicted and punished according to other crimes. If it is really necessary to investigate the criminal responsibility for the crime of illegal business operation in cases with particularly serious harmful consequences and particularly bad social impact, it can be regarded as a special case, and the Supreme People's Court can be asked step by step according to the requirements of the Notice of the Supreme People's Court on Accurately Understanding and Applying the "State Provisions" in the Criminal Law on April 8, 201KLOC-0.
(3) Criminal responsibility of the crime of obstructing drug administration
1. Criminal circumstances, aggravating circumstances and corresponding legal penalties. In accordance with the provisions of Article 142- 1 of the Criminal Law, those who constitute the crime of obstructing drug administration shall be sentenced to fixed-term imprisonment of not more than three years or criminal detention, and shall also or only be fined; Whoever causes serious harm to human health or has other serious circumstances shall be sentenced to fixed-term imprisonment of not less than three years but not more than seven years and shall also be fined. For the determination of "causing serious harm to human health or other serious circumstances", the provisions of Article 8 of the Interpretation of Handling Criminal Cases Endangering Drug Safety can be directly applied. According to this article, an act that interferes with drug administration in any of the following circumstances shall be deemed as "causing serious harm to human health" as stipulated in Article 142 of the Criminal Law: (1) causing minor injuries or serious injuries; (2) Causing mild or moderate disability; (three) causing damage to organs and tissues, resulting in general dysfunction or serious dysfunction; (4) Other circumstances that cause serious harm to human health.
Acts that interfere with drug administration are enough to seriously endanger human health. Under any of the following circumstances, it shall be deemed as "other serious circumstances" as stipulated in Article 142 of the Criminal Law: (1) producing and selling drugs that are prohibited from being sold by the drug supervision and administration department of the State Council, and the production and sales amount is more than 500,000 yuan; (2) producing, importing or selling drugs knowing that they are drugs without obtaining the relevant approval documents for drugs, and the amount of production and sales is more than 500,000 yuan; (3) Providing false certificates, data, materials and samples in the application for drug registration or adopting other deceptive means, thus causing serious consequences; (four) fabricating production and inspection records, causing serious consequences; (5) Causing adverse social impact or other serious circumstances.
2. Principles for handling the related concurrence of the crime of obstructing drug administration. According to the second paragraph of Article 142- 1 of the Criminal Law, there is an act of obstructing drug management. If the drugs are identified as counterfeit drugs and inferior drugs through quality inspection, they may also constitute the crime of producing, selling and providing counterfeit drugs in Article 14 1 and the crime of producing, selling and providing inferior drugs in Article 142 of the Criminal Law. Paragraph 3 of Article 8 of the Interpretation on Handling Criminal Cases Endangering Drug Safety further clarifies that if the acts specified in Article 142 of the Criminal Law constitute the crime of producing, selling or providing counterfeit drugs, the crime of producing, selling or providing inferior drugs or other crimes, they shall be convicted and punished in accordance with the provisions of heavier punishment.
3. Punish the unit for the crime of obstructing drug supervision. If a unit commits this crime, it 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 crimes committed by natural persons stipulated in the Interpretation on Handling Criminal Cases Endangering Drug Safety. The punishment here includes a fine in addition to the principal punishment. If a unit commits a crime, the total amount of fines imposed on the defendant unit, its directly responsible person in charge and other directly responsible personnel is generally more than twice the amount of drugs produced, sold and provided.
4. Penalties for fines. According to the provisions of Articles 15 and 17 of the Interpretation of Handling Criminal Cases Endangering Drug Safety, for the crime of obstructing drug management, the fine should generally be more than double the number of drugs produced, sold and provided; * * * with the crime, the total amount of fines imposed on each * * * accomplice should generally be more than twice the amount of drugs produced, sold and provided. The explanation of handling criminal cases endangering drug safety has increased the fine penalty, which is of great significance to curb crimes endangering drug safety. But while seeing this, we should also be aware of its disadvantages. For example, under the influence of interest-driven, there may be a phenomenon that individual courts do not take the criminal circumstances as the main basis, and once they find that the defendant has strong financial resources, they will impose huge fines. In view of this, Article 16 of the Interpretation on Handling Criminal Cases Endangering Drug Safety also stipulates that the crime of obstructing drug administration shall be punished according to law, and the defendant's criminal amount and illegal income shall be comprehensively considered, taking into account the defendant's ability to pay fines.
5. The principle of application of reprieve. Criminals who interfere with drug administration shall be strictly suspended and exempted from criminal punishment in accordance with the conditions stipulated in the Criminal Law. Where probation is applied, an injunction shall be issued at the same time to prohibit criminals from engaging in drug production, sales and related activities during the probation period of probation.
(Yuan Changlun, lawyer of Anhui Jinyapu Law Firm, director of property crime defense department, master of criminal law in northwest university of politics and law, retired judge,15212781535).