The free distribution of medical devices in the pa

2022-08-21
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How to deal with the illegal phenomenon of free distribution of medical devices in drug packaging

during daily supervision and inspection, drug regulatory and law enforcement personnel found that the free distribution of disposable syringes in some drug packaging was illegal. Law enforcement personnel have different opinions on how to deal with this situation. Some law enforcement personnel believe that they should be punished according to the relevant provisions of the regulations on the supervision and administration of medical devices; Some law enforcement officials believe that the matching drugs should be confiscated (whether qualified or not); Some law enforcement officials believe that the disposable syringes in the drug packaging are distributed free of charge, which are not sales and should be ordered to return. The discussion organized on this topic in this edition is expected to be helpful to your future work practice

-- editor's press

■ view 1: punishment according to the regulations on the supervision and administration of medical devices

first of all, when selling drugs, it is natural to sell drugs together with their packaging materials and other accessories to consumers. When consumers buy drugs, they also require to buy drugs, drug instructions and packaging materials as a whole, that is to say, consumers spend money to buy not only the drugs themselves, We also bought drug packaging materials and other accessories

secondly, drugs, drug packaging materials and accessories in packaging materials, such as syringes, have their own use value and value. When disposable syringes and other accessories are sold together with drugs as a whole commodity, the selling price must include the selling price of syringes and other accessories. For example, the price of erythromycin tablets sold by merchants is 5 yuan, which is the sum of the price of 100 tablets, drug bottles, drug packaging boxes and other accessories. Therefore, whether businesses sell drugs in the name of drugs or give disposable syringes free of charge, it can not change the fact that businesses sell drugs and also bundle syringes

thirdly, disposable syringes are the same as the packaging of drugs, and manufacturers must be responsible for its quality. When drugs are sold as commodities, it is not only required that the drugs themselves meet the requirements, but also that their packaging materials and other accessories should be qualified and comply with the regulations. If the accessories such as drug packaging materials are damaged or unqualified and do not meet the legal requirements, the whole commodity shall be deemed unqualified. According to the provisions of articles 1, 2 and 4 of the regulations on the supervision and administration of medical devices, drug regulatory law enforcement officers should deal with businesses (factories) according to law

drug manufacturers give disposable syringes free of charge in the drug packaging. Although the manufacturer claims to give them free of charge, because patients can only get disposable syringes by purchasing drugs, the gift behavior of drug manufacturers is conditional and requires patients to bear the obligation after purchase. This behavior belongs to the situation stipulated in Article 191 of the contract law, "For a gift with obligations, if the gift property is defective, the donor shall bear the same obligations as the seller within the limit of obligations." Therefore, once such free disposable syringes have illegal problems, drug manufacturers should bear them. In other words, drugs and disposable syringes are in the same package, and patients receive gifts at the cost of paying the price of drugs. Therefore, drug manufacturers must be responsible for the quality of disposable syringes. The author believes that administrative punishment should be imposed on drug manufacturers in accordance with the regulations on the supervision and administration of medical devices, but the punishment should not include drugs

at the same time of punishing drug manufacturers, the manufacturers of disposable syringes with illegal phenomena must be investigated and dealt with in accordance with the regulations on the supervision and administration of medical devices. Because the products with problems are produced by this unit, they cannot be exempted from liability because they have punished the drug manufacturing enterprises, so they still need to bear the corresponding administrative responsibilities

the author believes that punishment should be carried out in accordance with the regulations on the supervision and administration of medical devices and the measures for the supervision and administration of disposable medical devices (Provisional), for the following two reasons: first, free distribution belongs to bundling sales

disposable syringes distributed free of charge when selling drugs belong to indirect sales behavior. Medical devices distributed free of charge realize their value indirectly by selling drugs. The purpose of their behavior is to promote sales and speed up drug sales. It is called free, but it is actually paid sales, but the ways of realizing product value are different

second, this behavior of distributing gifts is regarded as sales behavior. Whether it is paid, whether it makes profits, or even loses money, cannot change the nature of its business behavior. Its behavior belongs to sales behavior, just like the relationship between the main contract and the subsidiary contract in the sales contract. Therefore, the nature of this behavior will not change because it is free distribution, and its illegal behavior should be punished in accordance with the regulations on the supervision and administration of medical devices and the measures for the supervision and administration of disposable medical devices (Provisional)

in addition, the practice of confiscating drugs or ordering the return of disposable syringes is inappropriate and has no legal basis

■ point 2: order to make corrections within a time limit

the behavior of the operator in distributing disposable syringes when selling drugs has violated the provisions of item (5) of Article 72 of the detailed rules for the implementation of the quality management standards for pharmaceutical trading, and the sale of drugs shall not be in the form of prize sale, complimentary drugs or gifts. Therefore, punishment should be given according to the provisions of Article 79 of the drug administration law, that is, if drug production and trading enterprises, drug non clinical safety evaluation and research institutions, and drug clinical trial institutions fail to implement the quality management norms of drug production, the quality management norms of drug operation, the quality management norms of drug non clinical research, and the quality management norms of drug clinical trials in accordance with the provisions, they should be given a warning and ordered to make corrections within a time limit; If it fails to make corrections within the time limit, it shall be ordered to stop production or business for rectification and be fined not less than 5000 yuan but not more than 20000 yuan; If the circumstances are serious, the "drug production license", "drug trading license" and the qualification of drug clinical trial institutions shall be revoked

therefore, the author believes that the handling of this case should be to give a warning to the party concerned and order it to measure and maintain the standard experimental method for the lowest oxygen concentration (oxygen index) of plastic candle burning ASTM D2863 ⑵ 000, which should be corrected within a time limit

from the perspective of drug supervision, only drugs that conform to it can be contained in drug packages. Article 54 of the drug administration law stipulates that drug packages must be printed or pasted with labels and instructions in accordance with regulations. This means that the drugs in the package can only be operated and used if they are consistent with the package label or instructions. Obviously, the free distribution of disposable syringes in the drug package violates this provision. In accordance with the provisions of Article 86 of the drug administration law, administrative penalties should be imposed, that is, a warning should be given and it should be ordered to make corrections

the author believes that the free distribution of disposable syringes must meet five conditions: (1) the free distribution unit must have legal qualifications; (2) The object of free distribution must be a legally qualified medical institution; (3) Disposable syringes delivered free of charge must have the product registration certificate, production and manufacturing approval form, certificate of conformity and other relevant legal documents of the product; (4) The disposable syringes delivered free of charge must be the original products in the original packaging, and the labels or instructions must be consistent inside and outside; (5) The free distribution unit must also issue the corresponding distribution list and invoice of the product (indicate free distribution on the invoice). Otherwise, disposable syringes cannot be delivered free of charge

■ view 3: manage according to drug packaging

the author believes that the disposable syringes distributed free of charge in drug packaging are part of drug packaging and should be managed according to drug packaging. Article 3 of the provisions on the administration of drug packaging, labels and instructions (Provisional) stipulates that no unapproved text, audio-visual and other materials introducing or promoting products and enterprises are allowed in the drug packaging. The first paragraph of Article 52 of the drug administration law stipulates that the packaging of drugs shall be approved at the same time as the approval of drugs. Therefore, the legitimacy of such drugs should be examined to see whether the disposable syringes distributed have been approved. If they are approved to be legal, they can be operated and used; If it is not approved, the drugs shall be investigated and punished as inferior drugs in accordance with the provisions of paragraph 3 (4) of Article 49 of the drug administration law, and the drug packaging containing disposable syringes shall be ordered to stop using by the drug supervision and administration department in accordance with the provisions of paragraph 3 of Article 52 of the law

■ point 4: it depends on the illegal subject

when dealing with such cases, the drug regulatory department can take different treatment methods for different illegal subjects, that is, the operator can be ordered to take active measures to take back the disposable syringes that have been distributed free of charge; Producers should be punished according to law

the author believes that for operators, this behavior should be characterized as selling drugs. Because the operators, from purchase to sale and then to profit, take drugs as the object, rather than disposable syringes as the object. The manufacturer binds the two together for sales, which is a marketing method of the manufacturer. Because drugs are packaged with disposable syringes, operators have no choice and do not make profits from disposable syringes themselves. Therefore, according to the principle of fairness and reasonableness, the drugs sold by them should not be punished because they are equipped with disposable syringes, but should be ordered to take them back. Drug manufacturers distribute disposable syringes free of charge in drug packaging. Because the cost of syringes has been included in the cost of drugs, and it pursues profits by taking drugs and syringes as a whole. Therefore, it must take full responsibility for it. If this disposable syringe is produced by the enterprise itself, the drug regulatory department shall investigate its relevant laws in accordance with the regulations on the supervision and administration of medical devices. If the disposable syringe is purchased by the enterprise from other enterprises, the law of its illegal operation shall be investigated according to law, and then the law of the disposable syringe manufacturer shall continue to be investigated

although drugs and disposable syringes belong to the jurisdiction of the (food) drug administration, the applicable legal provisions are different. The main laws and regulations for drug administration are the drug administration law and the regulations for the implementation of the drug administration law. Disposable syringes belong to class II medical devices, and the main laws and regulations are the regulations for the supervision and administration of medical devices. We can divide sales into two contract behaviors: the sale of drugs is the main contract, and the distribution of disposable syringes is the secondary contract. The invalidity of the subordinate contract cannot naturally lead to the invalidity of the main contract. The defect of the subordinate does not mean that the main contract is defective. Therefore, the distribution of disposable syringes cannot be considered illegal, and the drug is also illegal. Of course, in order to ensure the quality of drugs, it is also necessary to send the drugs for inspection when conditions permit. The sale of the drug should be stopped before the results are released

at the same time, we should consider whether the crime unit is a business unit or a user unit. If it is a business unit, we should also see whether the unit has the qualification to operate disposable syringes. If not,

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