Case Facts Recently, a local market supervision bureau received reports from the public that the "Ding Guier Navel Patch" operated by a pharmaceutical company was suspected of being an infringing product and requested investigation and punishment. After receiving the report, the bureau immediately sent law enforcement officers to the company to inspect it. After investigation, the outer packaging of the "Ding Guier Navel Patch" operated by this company is marked: "Product name: a certain brand of diarrhea health patch; ingredients: clove, cinnamon, long pepper, cumin, star anise, agarwood, angelica, frankincense, myrrh; Properties: This product is a brown, round ointment; it has a fragrant aroma. Suitable people: It can strengthen the spleen and warm the body, dispel cold and stop diarrhea. It is suitable for sub-healthy people with chronic diarrhea." The product is also marked in a prominent position on the outer packaging with "Instructions for use: external use; Approval number: A certain health use word 2004 No. N000N." Law enforcement officers found that the color, pattern, style, wording, etc. of the product's outer packaging were all the same as those of a certain The "Ding Guier Umbilical Patch" produced by well-known pharmaceutical companies are highly similar, for example, they are all marked with the words "A certain treasure Yi Tie Ling, Ding Guier Umbilical Patch" and so on. Subsequently, the market supervision bureau sent a letter to the regulatory authority where the manufacturer of the product was labeled to conduct a coordinated investigation. After co-investigation, the supervisory department of the location of the labeling manufacturer responded with a letter stating that the labeling manufacturer had never produced the above-mentioned products. There are different opinions on how to characterize the punishment in this case. Law enforcement officials hold three different opinions: The first opinion is that the outer packaging of the "Ding Guier Navel Patch" operated by the party has been marked with an approval number and is suitable for sub-healthy people with chronic diarrhea. It should be It is a health care product. The words "Mou Bao Yi Tie Ling" marked on the outer packaging of the product are consistent with the trademark "Ding Guier Navel Patch" produced by a well-known pharmaceutical company. It can be determined that his behavior violated the "Trademark Law of the People's Republic of China" (hereinafter referred to as the Trademark Law ) Item (3) of Article 57 shall be handled in accordance with Paragraph 2 of Article 60 of the Trademark Law. If the party knowingly knows that the products it sells are products that infringe trademark rights but continues to sell them, and the sales amount reaches the level of counterfeit The criteria for filing a case for the crime of registered trademark shall be transferred to the public security organs for handling according to law. In addition, the outer packaging of this product is highly similar to the "Ding Guier Navel Patch" produced by a well-known pharmaceutical company in terms of color, pattern, style, etc. Its behavior complies with the "Anti-Unfair Competition Law of the People's Republic of China and the State" (hereinafter referred to as "Anti-Unfair Competition Law"). Item (1) of Article 6 of the Anti-Unfair Competition Law stipulates that any act that constitutes confusion shall be dealt with in accordance with Article 18 of the Anti-Unfair Competition Law. The above two illegal acts were both completed under the will of the parties intending to sell a product, and should be considered as the same illegal act, so they can only choose one and be severely punished. The second opinion is that the name, ingredients, and purpose of use marked on the outer packaging of the "Ding Guier Umbilical Patch" sold by the party concerned are in compliance with the relevant drugs in the newly revised "Drug Administration Law of the People's Republic of China" (hereinafter referred to as the Drug Administration Law) According to the definition, it should be recognized as a drug. However, the product was not labeled with a drug approval number and a joint investigation found that the manufacturer with the labeled product did not produce the product. Therefore, the product involved should be considered a drug produced without approval documents. If the illegal behavior of the parties constitutes the sale of drugs produced without approval documents, they shall be punished in accordance with the provisions of Article 124 of the Drug Administration Law. Other illegal acts by parties such as infringement of trademark rights, confusion and unfair competition should be dealt with in accordance with legal provisions, that is, in accordance with Article 29 of the "Administrative Punishment Law of the People's Republic of China" (hereinafter referred to as the "Administrative Punishment Law") According to the regulations, handling shall be carried out in accordance with the provisions of Article 124 of the Drug Administration Law, which imposes high fines. The third opinion holds that the information marked on the outer packaging of the "Ding Guier Navel Patch" operated by the party concerned formally complies with the definition of drugs in the Drug Administration Law, and the product should be formally recognized as a drug. In addition, the products involved in the case were labeled as health products on the outer packaging, with the purpose of selling non-drugs as drugs in order to deceive consumers. For this reason, the products involved in the case should be identified as counterfeit drugs in accordance with the provisions of Article 98, Paragraph 2, Item (2) of the Drug Administration Law, and transferred to judicial authorities for processing. Commentary The author agrees with the third opinion in principle, but whether it can be determined that the drugs sold by the parties are passed off as non-drugs requires attention from the following aspects: First, for non-drug products such as cosmetics and disinfection products marked on the outer packaging , which promotes its efficacy and uses medical terms through outer packaging, labels, instructions, etc., can it be formally recognized as a drug? The author believes that it should be determined on a case-by-case basis.

If the outer packaging, labels, instructions and other contents of the above-mentioned types of non-drug products comply with the definition of drugs in the Drug Administration Law, they should be identified based on their stated purpose of use, method of use, user group, product ingredients, etc., especially Focus on the intended use of the product. For example, the outer packaging of the "Ding Guier Umbilical Patch" sold by the party in this case clearly states that the purpose of the product is to strengthen the spleen and warm the body, dispel cold and stop diarrhea. From this, it can be inferred that the purpose of the product sold by the party is to treat or alleviate the above-mentioned diseases or symptoms, which complies with drug management. According to the law, drugs are used for the purpose of preventing, treating, and diagnosing human diseases, so the product can be deemed to be a drug in form. If the approval number (recording number) marked on this type of product is verified to be false, but the manufacturer has indeed produced this type of product and the product has been approved (recorded), the law enforcement agency should label the product according to the The product category shall be handled in accordance with the departmental laws corresponding to the product category. Even if it can be recognized as a drug in form, it is usually not suitable to be treated as a drug. This is consistent with the law enforcement recommendations in the "Announcement on Carrying out Rectification Actions for Non-drug Counterfeit Drugs" jointly issued by the former State Food and Drug Administration and the former Ministry of Health in 2009. There is also a view that the identification of "passing off non-drugs as drugs" proposed in Article 98, Paragraph 2 (2) of the Drug Administration Law, in law enforcement practice, law enforcement agencies need to make specific decisions on what kind of drugs the drugs involved in the case are being passed off as. Only then can the product involved in the case be identified as a non-drug passing off as a drug. However, the author believes that drugs are a relative concept. Article 2, Paragraph 2 of the Drug Administration Law defines the connotation and extension of drugs, that is, as long as they can be used to prevent, treat, and diagnose human diseases and purposefully regulate human physiological functions, it stipulates Substances that have indications or functional indications, usage and dosage can be included in the scope of drugs. Accordingly, if the outer packaging, labels, instructions, etc. of the product indicate content related to the concept of a drug, the product can be identified as a non-drug counterfeiting a drug without determining the specific name of the drug being counterfeited. Second, after the above-mentioned products are formally recognized as drugs, should they be inspected before they can be identified as counterfeit drugs? The author believes that there is no need for inspection. As mentioned above, to identify a product as a non-drug passing off as a drug, there is no need to determine the specific name of the drug it is passing off, as long as it is formally recognized as a drug. In this case, drug testing requires corresponding standards and reference materials. However, it is unknown how to obtain inspection standards and reference materials for a product that is passed off as a non-drug. In addition, the State Food and Drug Administration made it clear in its reply to the Guizhou Provincial Food and Drug Administration's "Reply Letter from the General Department of the State Food and Drug Administration on Issues Concerning the Identification of Counterfeit and Substandard Drugs" that the identification of counterfeit and substandard drugs can be based on factual determination, but not all The test conclusion needs to be stated. Third, regarding the competing legal provisions that may be involved in counterfeiting non-pharmaceutical drugs. As far as this case is concerned, the author believes that the first view is valid to determine that the products sold by the parties involved trademark infringement and unfair competition. However, in the field of pharmaceuticals, the legal interests involved include not only the social and economic management order, but also the health and safety of an unspecified majority of people. At the same time, in accordance with the principle of "special laws are superior to general laws", the Drug Administration Law should be given priority for illegal issues involving drug quality and safety. The second view is that since the product sold by the party can be formally determined to be a drug, and the drug has not obtained a drug approval document, the party's behavior should be deemed to be an illegal sale of a drug that has not obtained a drug approval document. The author believes that This is administratively correct. However, according to the criminal priority system established in Articles 113 and 114 of the Drug Administration Law, that is, as long as the illegal behavior of the party is suspected of constituting a crime, it should be promptly transferred to the judicial authority for processing. In illegal cases where labels, instructions, etc. promote efficacy, use medical terms, etc., and use non-drugs to pass off as drugs, as long as it can be determined legally and practically that the product involved is a non-drug passing off as a drug, it can be deemed to be a counterfeit drug in accordance with the law and transferred to the judiciary in accordance with the law. Agency processing.