People's Daily Online, Beijing, May 19 (Reporter Sun Hongli) "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 Endangering Drug Safety" (hereinafter referred to as the "Interpretation") will come into force on March 6, 2022 .
Recently, the official website of the State Food and Drug Administration issued a document to interpret the "identification of counterfeit and substandard drugs" and "severe punishment for crimes of counterfeit and substandard drugs".
Identification of counterfeit and inferior drugs
"For the counterfeit and inferior drugs in the six cases, if a judgment can be made based on the evidence materials, there is no need to inspect the drugs involved." The indicated indications or functions and indications are beyond the prescribed scope; the medicines whose expiration date is not marked or changed; the medicines whose product batch number is not marked or changed; the medicines whose expiration date has expired; Packaging, and making judgments based on the confessions of criminal suspects and defendants and other evidence materials, the drug supervision and administration department at or above the prefecture level may issue a determination opinion, and there is no need to inspect the drugs involved.
Among them, there are disputes over whether it is a counterfeit drug that is "passed off as a drug with a non-drug or a drug of another kind", or an inferior drug that is "a drug with preservatives and excipients added without authorization"; The other five cases of counterfeit and substandard drugs shall be inspected by a drug inspection agency established or determined by the drug regulatory department at or above the provincial level, and a quality inspection conclusion shall be issued.
Judicial organs make a determination based on the determination opinions, inspection conclusions, and other evidence.
It is understood that according to the provisions of the Drug Administration Law, it is a counterfeit drug under any of the following circumstances: the ingredients contained in the drug do not conform to the ingredients specified in the national drug standards; Drugs; the indicated indications or functions of the drug are beyond the prescribed scope.
In any of the following circumstances, it is considered an inferior drug: the content of drug ingredients does not meet the national drug standards; contaminated drugs; drugs with no indication or change of expiry date; drugs with no indication or change of product batch number; Drugs with added preservatives and excipients; other drugs that do not meet drug standards.
Severely punish crimes of counterfeit and inferior drugs
The "Interpretation" also clarifies the production, sale, provision of counterfeit and inferior drugs, and severe punishment as appropriate: the drugs involved in the case are mainly used by pregnant women, children or critically ill patients; the drugs involved are narcotic drugs, psychotropic drugs, medical toxic Drugs, radioactive drugs, biological products and other drugs; the drugs involved are injection drugs and emergency drugs; the drugs involved are used to deal with emergencies such as natural disasters, accident disasters, etc.; drug users and their staff produce and sell fake and inferior drugs.
According to Article 141 of the Criminal Law, if the production, sale or supply of counterfeit medicines causes death or other particularly serious circumstances, the maximum penalty shall be death and property confiscation.
According to the provisions of Article 142 of the Criminal Law, if the consequences of producing, selling or providing inferior medicines are particularly serious, the maximum penalty shall be life imprisonment and confiscation of property.
In addition, according to the "Interpretation", if a drug-using unit and its staff clearly know that it is a fake or inferior drug and provide it to others for use, it should be recognized as one of the provisions in Articles 141 and 142 of the Criminal Law. "Sale"; if it is provided to others for use without compensation, it shall be identified as "providing" as stipulated in Articles 141 and 142 of the Criminal Law.
It is understood that on March 4, the Supreme People's Court and the Supreme People's Procuratorate jointly issued the Interpretation.
The Interpretation clarifies the conviction and sentencing standards for crimes of producing, selling, and supplying counterfeit and substandard drugs and issues related to the application of laws, fully reflecting the policy orientation of severely punishing crimes of counterfeit and substandard drugs in accordance with the law.
On March 11, Xu Jinghe, a member of the party group and deputy director of the State Food and Drug Administration, pointed out that the "Interpretation" is an important boundary for judging violations and crimes in the pharmaceutical field, and provides strong support for strengthening drug safety supervision and cracking down on crimes in the pharmaceutical field.