The Drug Administration Law of the People's Republic of China, amended on August 26, 2019, adjusted the scope of fake and inferior drugs, and stipulated four situations of counterfeit drugs according to the quality and efficacy of drugs. In judicial practice, producers and traders use raw materials of unknown origin or composition to produce drugs for sale or confuse food and drugs, add drugs to food, or even sell or provide them to patients for the treatment of diseases. In this paper, we will analyze and discuss the identification of counterfeit drugs based on the substantive standards of drug quality and efficacy, in order to clarify the scope of counterfeit drugs.
1. Standards for distinguishing medicines from food for the purpose of treating human diseases
Accurately defining the scope of drugs is a prerequisite for effectively cracking down on crimes endangering drug safety. In accordance with Article 2 of the Drug Administration Law of the People's Republic of China (hereinafter referred to as the Drug Administration Law), Article 42 of the Regulations for the Implementation of the Drug Administration Law of the People's Republic of China and other relevant provisions, drugs refer to substances used for the prevention, treatment and diagnosis of human diseases, purposefully regulating human physiological functions, and stipulating indications or functional indications, usage and dosage. Non-pharmaceutical products shall not be advertised on their packaging, labels, instructions and relevant publicity materials that contain relevant content such as prevention, treatment and diagnosis of human diseases. Therefore, the drug should have efficacy characteristics and form characteristics, the efficacy characteristics refer to the drug should have the function of preventing, treating and diagnosing human diseases, and purposefully regulating human physiological functions, and the form characteristics refer to the characteristics of the drug generally should be specified with indications or functional indications, usage and dosage. In accordance with Articles 38 and 150 of the Food Safety Law of the People's Republic of China, Article 23 of the Measures for the Administration of Health Foods, and other relevant provisions, food does not include items for the purpose of treatment, and no drugs other than traditional food and Chinese herbal medicines shall be added to the food produced and traded, and there shall be no propaganda that suggests that the disease can be cured. Therefore, it is an important criterion to distinguish between drugs and foods for the purpose of treating human diseases, and foods do not include substances for the purpose of treatment. Where drugs prohibited by the state are illegally added to foods produced and operated, such as sibutramine in weight loss products, sildenafil in health care products, etc., or even sold or provided to others for the treatment of diseases, facts and evidentiary materials such as the defendant's occupation, raw materials, product packaging (labels, instructions, signs, etc.), publicity materials, sales venues, sales targets, witness testimony, victim statements, and defendants' confessions may be used to accurately determine that the producers and operators produced, sold, or Provide whether the items involved in the case are intended to treat a person's disease, and then accurately determine the nature of the items involved in the case. The production and sale of food that is not for the purpose of treating human diseases and contains drugs prohibited by the state shall be recognized as toxic or harmful food. The production, sale, or provision of substances for the purpose of treating human diseases shall be recognized as medicines, and whether they contain pharmaceutical ingredients or have the effects that drugs should have does not affect the determination of their properties.
2. Those that reduce or lose the due efficacy of drugs are counterfeit and shoddy products
The second paragraph of Article 98 of the Drug Administration Law stipulates four circumstances for identifying counterfeit drugs in accordance with the requirements of drug safety, effectiveness and quality controllability, and in accordance with the drug quality and efficacy standards, among which "the ingredients contained in the drug do not conform to the ingredients specified in the national drug standards", which is a counterfeit drug. The first paragraph of Article 28 of the Drug Administration Law stipulates that "drugs shall comply with national drug standards." If the drug quality standard approved by the drug regulatory department of the State Council is higher than the national drug standard, it shall be implemented in accordance with the approved drug quality standard; "The ingredients of drugs directly affect the quality of drugs, and the ingredients contained in the drugs do not conform to the ingredients specified in the national drug standards, such as the lack of ingredients specified in the national drug standards or the illegal addition of ingredients other than those specified in the national drug standards, it is a fake drug.
The approved drug quality standards and other drug standards are not the standards for the identification of counterfeit drugs as stipulated in Article 98, Paragraph 2 (1) of the Drug Administration Law. Drug standards include national drug standards, approved drug quality standards, processing specifications formulated by provincial drug regulatory agencies and other drug standards, and Article 28 of the Drug Administration Law stipulates that national drug standards refer to the Pharmacopoeia of the People's Republic of China promulgated by the national drug regulatory department and drug standards, and Article 98, Paragraph 2 (1) clearly stipulates that counterfeit drugs shall be identified in accordance with the drug ingredients specified in the national drug standards, so before the drug administration law or other laws expressly stipulate, for both national drug standards and approved drug quality standards or other drug standards, and there is no national drug standard but only approved drug quality standards or other drug standards, it should not be determined that the ingredients contained in the drug are not consistent with the ingredients specified in the approved drug quality standards or other drug standards, otherwise there is a suspicion of analogous interpretation。
For those who do not have national drug standards, but only have approved drug quality standards or other drug standards, and are adulterated or adulterated in drugs, resulting in the ingredients contained in the drugs not conforming to the ingredients specified in the approved drug quality standards or other drug standards, and reducing or losing the due efficacy of the drugs, although they cannot be identified as counterfeit drugs, they are in accordance with Article 1, Paragraph 1 of 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 the Production and Sale of Counterfeit and Shoddy Goods" (hereinafter referred to as the "Interpretation") Article 140 of the Criminal Law stipulates that 'adulteration or adulteration in products' refers to the act of adulterating impurities or foreign substances into products, resulting in the quality of products not meeting the quality requirements stipulated in national laws, regulations or express quality standards of products, and reducing or losing the performance that should be used", which shall be recognized as counterfeit and shoddy products. In accordance with the provisions of the first paragraph of Article 149 of the Criminal Law, "the production or sale of products listed in Articles 141 to 148 of this section does not constitute a crime provided for in each of these articles, but the sales amount is more than 50,000 yuan, it shall be convicted and punished in accordance with the provisions of Article 140 of this Section", where a manufacturer or trader adulterates or adulterates a drug, produces the aforementioned drug, or sells it knowing that it is the aforementioned drug, and meets the constitutive elements of the crime of producing or selling counterfeit or shoddy products, it shall be convicted and punished in accordance with the provisions of Article 140 of the Criminal Law. If the above-mentioned drugs are at the same time other drugs that do not meet the drug standards as provided for in Article 98, Paragraph 3 (7) of the Drug Administration Law, causing serious harm to human health, and meeting the constitutive elements of the crime of producing, selling, or providing inferior drugs, they shall be convicted and punished in accordance with the principle of special law taking precedence over ordinary law, and in accordance with the provisions of Article 142 of the Criminal Law.
3. It is not appropriate to identify the situation of "passing off other drugs as such drugs".
In accordance with the provisions of Article 98, Paragraph 2 (2) of the Drug Administration Law, passing off non-drugs as drugs or passing off other drugs as such drugs is a counterfeit drug. The biggest difference between different drugs is that the indications or functional indications of the drugs are different, and the passing off of non-drugs as drugs or other drugs that do not have specific functions and indications as such drugs cannot achieve the due efficacy of the drugs and should be recognized as counterfeit drugs. Paragraph 2 of Article 1 of the Interpretation stipulates: "'Passing off a fake as a genuine' as provided for in Article 140 of the Criminal Law refers to the act of passing off a product that does not have a certain performance as a product that has that performance. ”
For those who do not have national drug standards and do not have approved drug quality standards or other drug standards, and it is impossible to find out whether the drug has a specific functional indication, or at least cannot be ruled out as having a specific functional indication, it is not appropriate to identify it as a counterfeit drug in accordance with the provisions of "passing off other drugs as such drugs". Producers and traders use raw materials of unknown origin and composition to produce drugs, and do not use generic names of drugs or other drug trademarks, product packaging (labels, instructions, There are no national drug standards and no approved drug quality standards or other drug standards, and may be limited by factors such as inspection and testing technology, and the evidence in the case cannot ascertain whether the drug involved in the case has a specific functional indication, or at least cannot be ruled out as having a specific functional indication, does not meet the substantive standards for determining counterfeit drugs based on drug quality and efficacy, and should not be identified as a counterfeit drug in accordance with the provisions of "passing off other drugs as such drugs". If it meets the requirements of Article 7, Paragraph 1 (3) of 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", "the production of drugs without obtaining relevant approval documents for drugs or the sale of drugs knowing that they are the above-mentioned drugs, and the indications, functional indications or ingredients of the drugs involved in the case are unknown" and (4) Where drugs are produced without obtaining relevant approval documents for drugs, or they are sold knowing that they are the drugs described above, and the drugs involved in the case do not have national drug standards and there are no approved drug quality standards, but chemical drug ingredients are detected", and other circumstances meet the constitutive elements of the crime of obstructing drug management, it is to be convicted and punished in accordance with the provisions of Article 142-1 of the Criminal Law.
Author: Li Xinlei Li Lei, Author's Affiliation: Henan Provincial High People's Court, Transferred from: Criminal Memorandum