The SPC issued a typical case of drug safety: the sale of Chinese medicine tablets should inform the decoction method and precautions

Text/Yangcheng Evening News all-media reporter Dong Liu

The Supreme People's Court today (April 28) released 10 criminal, administrative and civil typical cases related to drug safety.

According to statistics from the Supreme People's Court, from 2013 to 2021, courts across the country have concluded more than 27,000 first-instance criminal cases involving the crimes of producing, selling and providing counterfeit drugs, the crimes of producing, selling and providing inferior drugs, and the crime of obstructing drug management, and more than 36,000 people have been sentenced, and a large number of drug safety crimes have been convicted and punished on related crimes such as the crime of producing and selling counterfeit and shoddy products, effectively deterring and cracking down on crimes that endanger drug safety.

At the same time, a large number of administrative and civil cases involving counterfeit drugs and inferior drugs have been concluded, effectively maintaining the order of drug operation and management, and effectively protecting the legitimate rights and interests of the people.

The sale of Chinese medicine tablets should inform the decoction method and precautions

In the dispute between Zhong xx, Du xxjia, Du xx, du xx, a pharmacy, and Yuan xx's right to life, on July 6, 2017, Du xxx went to a pharmacy to buy 150 grams of xiangjia pi, and took 150 grams of xiangjiapi decoction water that night, and suffered chest tightness, nausea, and vomiting, and was sent to the hospital by his family, and died after rescue was ineffective.

The market and quality supervision departments entrusted the inspection agency to conduct a sampling inspection of the Xiangjiapi involved in the case, and the inspection results were qualified products. A forensic appraisal research institute issued an "Autopsy Appraisal Opinion", which proved that Du X was in line with the death caused by poisoning caused by excessive consumption of xiangjiapi, which was the main cause of death; the underlying disease of coronary heart disease he suffered from played an auxiliary role in promoting death.

Du XX's wife Zhong XX, sons Du XX A and Du XX B sued the court on the grounds that a certain pharmacy sold xiangjiapi to Du xxx without a practicing physician or salesman without a work permit, and did not inform the decoction method and precautions, resulting in poisoning death, requiring a certain pharmacy and its shareholder Yuan XX to bear tort liability.

After trial, the court held that Article 19 of the Drug Administration Law of the People's Republic of China (2015 Amendment) stipulates that "pharmaceutical trading enterprises must be accurate in selling drugs, and correctly explain the methods, dosages and precautions...". The appraisal report pointed out that Du X was mainly poisoned due to excessive consumption of Xiangjiapi, a pharmacy was the seller of Xiangjiapi, and Article 167 (4) of the Good Management Practice for Drug Business (2016) stipulates that "the sale of drugs shall meet the following requirements: (4) The sale of Chinese medicine tablets shall be accurately measured, and the decoction method and precautions shall be informed; the provision of Chinese medicine tablets for decoction shall comply with the relevant provisions of the state." ”

A pharmacy has the obligation to inform Du of the method and precautions for decocting xiangjia peel when selling xiangjiapi, and the existing evidence is insufficient to prove that a pharmacy has fulfilled its obligation to inform, and a pharmacy has the obligation to inform but has failed to act, which is at fault and constitutes infringement; the damage result in this case is the death of Du xxx, the faulty behavior of a pharmacy has a causal link with the death of Du xx, and a pharmacy should bear fault liability.

Because the death of Mr. Du was caused by the pharmacy's failure to fulfill its obligation to explain and inform, and its own fault and its own disease, the pharmacy and Mr. Du should each bear 50% of the responsibility.

The court then ruled: First, a pharmacy compensated Zhong xxx, Du xxjia, and Du xx b. 1249.5 yuan for treatment expenses, 28,735 yuan for funeral expenses, 315403 yuan for death compensation, 16,000 yuan for appraisal fees, and 50% of other expenses of 8,176 yuan, totaling 184,781.75 yuan; second, a pharmacy compensated Zhong xx, Du xxjia, and Du xx, and Du xx; third, a pharmacy should complete the above-mentioned payment compensation obligations within ten days after the judgment took effect; fourth, reject Zhong xxx, Du xxjia, and Du xxx. Du Mouyi's other litigation claims.

The Supreme People's Court said that unlike Western medicine, which has a clear instruction manual, the efficacy, toxicity, dosage, etc. of Chinese medicine tablets are not well known to the general public, and once the wrong drug is used, it is easy to threaten life, health and safety, triggering a tragedy similar to this case. The sale of Chinese medicine tablets should be accurately measured and informed of decoction methods and precautions.

The judgment in this case that the pharmacy that failed to fulfill its obligation to inform should bear corresponding tort liability for the death of the purchaser due to excessive consumption of xiangjiapi, which served as a warning to the operators of the sale of Chinese medicine tablets, warning them to pay full attention to the life and health safety of the drug buyers, and should fully fulfill their obligation to inform when selling Chinese medicine tablets, and inform the decoction method and precautions of Chinese medicine tablets.

Disinfection products that label therapeutic functions to mislead consumers into purchasing constitute fraud

In the dispute between Xu and a pharmacy over the sale and purchase contract, Xu purchased 10 boxes of "Buzhou" Pi Kangle preparations in a pharmacy in June 2016, and paid a total of 180 yuan. The "Instructions for the Preparation of "Buzhou" Pi Kang Le" states that the "role" is to inhibit and kill skin fungi and mold; the "approval number" is Lu Wei Zhi Zi (2013) No. 0029.

The scope of application of "Pi Kang Le" in the "Buzhou Series Product Introduction": skin infections caused by fungi, such as beriberi, tinea pedis, tinea capitis, tinea corporis, tinea pyriasis, leukophyton, puscreen, yellow ringworm, tinea versicolor (sweat spots), erythritis, candidiasis and all fungal skin itching; product advantages: The ancient saying "practice medicine does not cure ringworm, cure ringworm is shameful". Buzhou brand skin recreation, clear fungal ringworm, the effect is leading.

Xu mou believed that the pharmacy's act of selling non-drugs as drugs to him was illegal, so he sued the court to demand that the pharmacy return the purchase money and compensate it three times the losses according to the Consumer Rights and Interests Protection Law.

After trial, the court held that proprietors providing consumers with information such as the quality, performance, use, and validity period of goods or services should be true and comprehensive, and must not make false or misleading publicity.

The approval number of the product involved in the case is × Wei Consumption Certificate (20××) No. 00××, which is a sanitize product (disinfection product), but the instructions and product descriptions of the product indicate that it has the effect of treating fungal ringworm.

According to Article 48 of the Drug Administration Law of the People's Republic of China (Amended in 2015), "the production (including preparation, the same below) is prohibited from selling counterfeit drugs. Counterfeit medicine in any of the following circumstances: ... (2) Passing off a non-drug as a drug or passing off another kind of drug as such a drug" stipulates that the pharmacy sells non-drugs as drugs, causing Xu to make a wrong expression of intent, constituting fraud.

Xu's demand that the pharmacy return the purchase price and compensate its losses according to three times the price was in accordance with the law, and the court ordered the pharmacy to return Xu's shopping price of 180 yuan and compensate for the loss of 540 yuan.

The Supreme People's Court said that the pharmacies scattered throughout the streets and alleys of the city have brought convenience to the people to purchase drugs in a timely manner and eliminate the pain of illness. However, some pharmaceutical trading enterprises have illegally publicized the sale of disinfection, health care products have therapeutic functions, misleading consumers, endangering people's health. Disinfection products are not drugs, do not have the effect of regulating human physiological functions, can not be used to treat diseases, and there is a clear difference from drugs.

The "Disinfection Management Measures" clearly stipulates that the label (including instructions) and publicity content of disinfection products must be true and must not appear or imply the therapeutic effect on the disease. Consumers must pay attention to the product approval number when purchasing products, strictly distinguish between "National Pharmaceutical Quasi-brand Number" and "Health Consumption Certificate" products, and do not use disinfection products as medicines to avoid delaying the condition.

By determining that the disinfection products marked with therapeutic functions in the case are counterfeit drugs, and the drug trading enterprises mistakenly guiding consumers to purchase drugs constitutes fraud and applies the provisions on punitive damages, this case can not only play a due warning role for drug trading enterprises and regulate their business activities, but also help guide consumers to prudently and rationally choose therapeutic drugs and protect the legitimate rights and interests of consumers.

The sale of drugs that do not indicate the product batch number shall be liable for compensation

In the contract dispute case between Mr. Yang v. A pharmacy, a pharmacy was an individual industrial and commercial household registered with the Market Supervision Administration and operated by an individual. Its business scope is: prescription drugs and over-the-counter drugs, antibiotics, proprietary Chinese medicines, chemical preparations, health care products, prepackaged food sales (according to the law must be approved by the project, after the approval of the relevant departments can carry out business activities).

On June 10, 2019, Mr. Yang went to a pharmacy to buy "Viagra", and purchased 2 large boxes of "Cordyceps Sperm Capsules" under the introduction of the salesman, each with a unit price of 500 yuan; "Golden Viagra" 1 large box, with a unit price of 500 yuan; and "Kidney Treasure Tablets" 1 large box with a unit price of 500 yuan. The total price is 2,000 yuan. After Yang X paid the price in cash, the salesman did not issue a small ticket, and at the request of Yang X, the salesman hand-wrote a shopping list (a pharmacy payment slip) and stamped "A pharmacy cash receipt seal".

Later, Mr. Yang inquired about the information of the purchased "Cordyceps Sperm Capsule" through the official website of the State Food and Drug Administration, that is, he filed a lawsuit on the grounds that the purchased product was a toxic and harmful counterfeit drug.

After trial, the court held that the outer packaging of the goods involved in this case was marked with the efficacy of the goods, and its built-in instructions clearly stated its main ingredients, applicable populations, dosage, etc., and the above records all met the second paragraph of article 2 of the Drug Administration Law of the People's Republic of China (Revised in 2019) that "the drugs referred to in this Law refer to substances used to prevent, treat and diagnose human diseases, purposefully regulate human physiological functions and stipulate indications or functional indications, usage and dosage, including traditional Chinese medicines, chemicals and biological products." Regarding the definition of drugs, therefore, the court found that the commodities involved in this case, "Cordyceps Sperm Capsules", "Golden Viagra" and "Kidney Treasure Tablets", were drugs.

The first paragraph of Article 98 of the Drug Administration Law of the People's Republic of China (Revised in 2019) stipulates that "the production (including preparation, the same below) is prohibited from being produced (including formulated, the same below), the sale and use of counterfeit and inferior drugs." The third paragraph stipulates that "in any of the following circumstances, it is an inferior drug: (1) the content of the drug ingredients does not meet the national standards; (2) the contaminated drugs; (3) the drugs that do not indicate or change the validity period; (4) the drugs that do not indicate or change the product batch number; (5) the drugs that exceed the validity period; (6) the drugs that add preservatives and excipients without authorization; and (7) other drugs that do not meet the drug standards."

Both parties in this case agreed that the results of the inquiry results of the inquiry results of the information of "Cordyceps Sperm Capsules", "Golden Viagrass" and "Kidney Treasure Tablets" on the official website of the State Food and Drug Administration, and the "Cordyceps Essence Capsules", "Golden Viagrass" and "Kidney Treasure Tablets" sold to Yang by a pharmacy did not indicate the batch number of the drug product, which should be regarded as inferior drugs.

Yang X's request to order a pharmacy to refund the purchase price of 2,000 yuan and compensate ten times the price of the goods is in accordance with the law. A pharmacy was ordered to compensate Yang for the purchase price of 2,000 yuan and pay compensation of 20,000 yuan.

The Supreme People's Court said that food and drug safety is related to the health and life safety of the people, and the state has always adopted strict control measures. Paragraph 3 of Article 144 of the Drug Administration Law of the People's Republic of China (Revised in 2019) states that "where counterfeit or inferior drugs are produced or are known to be counterfeit or inferior drugs are still sold or used, the victim or his close relatives may, in addition to requesting compensation for losses, request compensation of ten times the price or three times the loss; if the amount of additional compensation is less than 1,000 yuan, it shall be 1,000 yuan." ”

The newly revised Drug Administration Law implements stricter management of drug safety, and increases the amount of compensation for the losses of victims who purchase counterfeit drugs for the production of counterfeit drugs, inferior drugs, or the behavior of knowing that they are counterfeit drugs or inferior drugs, and increases the amount of compensation for the losses of counterfeit drugs purchased by victims, which is of great significance to purifying the drug market, improving the awareness of food and drug safety among the masses, and promoting citizens' knowledge of the law and abiding by the law. (For more news, please pay attention to Yangcheng Pie pai.ycwb.com)

Source | Yangcheng Evening News Yangcheng Pie

Editor-in-charge | Wu Flaw