[Objection] Pharmaceutical Factory C added contents to the outer package of drug D without authorization, which violated Article 2 of the Regulations on the Administration of Drug Packaging, Labels and Instructions (Provisional) that "drug packaging, labels and instructions must be printed according to the requirements of the State Administration of Pharmaceutical Products, and their words and patterns must not contain unapproved contents" and Article 9 (1) that "the contents of inner packaging labels and outer packaging labels must not exceed those specified in the drug instructions approved by the State Administration of Pharmaceutical Products"; The written statement is consistent with the instructions "and the first paragraph of Article 54 of the Drug Administration Law" Drug packaging must be printed or labeled with instructions in accordance with regulations ",but when dealing with it, law enforcement officers have produced the following two opinions.
The first opinion is that the drug should be regarded as counterfeit. Reason: The contents of "anti-virus and cold treatment" printed on the outer packaging of the drug are the indications of the drug. If it is added without approval, it should be regarded as the indications of the drug beyond the prescribed scope. According to Item 6, Paragraph 3, Article 48 of the Drug Administration Law, if the indications or functional indications are beyond the prescribed scope, it shall be treated as counterfeit drugs and punished in accordance with Articles 86 and 74 of the Drug Administration Law.
The second opinion is that counterfeit and inferior drugs should not be punished, but should be ordered to correct and given a warning. Reason: Although the contents such as "anti-virus and cold treatment" printed on the drug package were added without approval, they were printed next to the trade name and trademark of the drug package, rather than under the indication column in the drug package and instructions. There is insufficient basis for identifying the contents as indications of drugs and cannot be classified as counterfeit drugs. At present, the contents of national drug standards mainly include: name, composition or prescription composition; Contents and inspection and inspection methods; Auxiliary materials of the preparation; Allowable impurities and their limits, technical requirements and functions, uses, usage and dosage, and precautions; Storage method; Packaging, etc. , and the above-mentioned unapproved content belongs to the limited content of drug packaging label beyond the national approval, and does not belong to the scope of national drug standards. Therefore, the provision of "other drugs that do not meet the drug standards" in Item (6) of Paragraph 3 of Article 49 of the Drug Administration Law is not applicable and cannot be classified as inferior drugs. According to the provisions of Article 86 of the Drug Administration Law, "If the drug label does not conform to the provisions of Article 54 of this Law, it shall be ordered to make corrections and given a warning in addition to being punished according to law for counterfeit drugs and inferior drugs; If the circumstances are serious, the drug approval certificate shall be revoked, and the drug supervision and administration department shall impose administrative punishment on the behavior of Pharmaceutical Factory C, order it to make corrections and give a warning.
At present, the contents of national drug standards mainly include: name, composition or prescription composition; Contents and inspection and inspection methods; Auxiliary materials of the preparation; Allowable impurities and their limits, technical requirements, functions, uses, usage and dosage; Precautions; Storage method; Packaging, etc. Standardizing drug packaging, labels and instructions is one of the important measures to ensure the safety and effectiveness of drug use by consumers, and it is also the need to maintain the order of the drug market, ensure fair competition and promote the healthy development of the pharmaceutical industry. According to the provisions of Article 54 of the Drug Administration Law on the management of drug packaging and Article 8 of the Provisions on the Management of Drug Packaging, Labels and Instructions (Provisional) on the content of packaging, outer packaging, as an important part of drug packaging, should also fall within the scope of national standards. Where the packaging, labels or instructions are modified or changed, the examination and approval procedures must be handled according to the original declaration procedures. This is because, for consumers, packaging is an important basis for judging whether drugs are suitable for their own symptoms so as to buy and take them. In this case, although the words "anti-virus and cold treatment" are printed next to the label of the drug package, rather than under the indication column in the drug package and instructions, for consumers with weak information, the distinction is not obvious, which may easily lead to a wrong judgment, that is, the words are integrated with the label, so it should be characterized as "the content of drug indications". From this point of view, the second opinion is incorrect in judging this issue. But whether it can be handled according to the production and sale of counterfeit drugs and inferior drugs, there is a question of interest consideration here.
From the analysis of Item (6) of Paragraph 3 of Article 48 of the Drug Administration Law that the indications or functional indications are beyond the prescribed scope, the behavior of Pharmaceutical Factory C in this case should be punished as producing and selling counterfeit drugs. However, judging from the interactive relationship between the purpose of law enforcement and the protection of the interests of the administrative counterpart, the treatment in the first opinion may not be reasonable, because the means of administrative law enforcement should conform to the principle of certain proportion. The legislative intent of Article 48 of the Drug Administration Law is to ensure the quality of drugs and the efficacy and safety of drugs in prevention, treatment and diagnosis. According to the definition of fake medicine in the second paragraph of this article, the so-called fake medicine means that the composition of the medicine is inconsistent with that stipulated by the national drug standard, and non-drugs are passed off as medicines or other medicines are passed off as medicines. This definition is because counterfeit drugs have arbitrarily changed the technical standards of ingredients in drugs stipulated by the national drug standards, resulting in inconsistencies between the ingredients in drugs and those stipulated by the national drug standards. It is difficult to ensure the exact curative effect of drugs in use, and it is even more impossible to ensure users to use drugs safely and effectively. Therefore, it should be identified as a counterfeit drug. In the same way, the six situations stipulated in the third paragraph of Article 48 of the Drug Administration Law should be treated as counterfeit drugs because the consequences may be the same or similar to those of counterfeit drugs. In this case, the words "anti-virus, cold treatment" are printed in the eye-catching position next to the product name of drug D produced by C pharmaceutical factory, but it has not yet constituted a fundamental change in the technical standards of drugs, and its consequences are different from those of counterfeit drugs. Therefore, it is inappropriate for the drug regulatory authorities to find that the behavior of Pharmaceutical Factory C violates the provisions of Article 48 of the Drug Administration Law, which prohibits the production and sale of counterfeit drugs, and to punish it according to the provisions of Articles 86 and 74 of the Law. We should embody the principles of appropriateness, necessity and proportionality in the choice of law enforcement methods. Among all kinds of means suitable for achieving the goal, we should choose the means with the least infringement on the rights of the administrative counterpart, which is the main connotation of the principle of proportionality in administrative law. Therefore, the author thinks that the treatment in the second opinion is correct.