Procuratorial public interest litigation focuses on the chaos of illegal addition of antibacterial (inhibitory) preparations under the "elimination" brand
Why a small box of cream attracted the attention of the procuratorate
□ Zhang Hao, reporter of this newspaper
According to this year's work report of the Supreme People's Procuratorate, procuratorial organs across the country have organized special supervision of public interest litigation against the illegal addition of chemical drugs to some "anti-bacterial" preparations that endanger health, urging the investigation and handling of more than 61,<> problematic products.
Recently, a reporter from "Rule of Law Daily" learned in an interview with the relevant person in charge of the Eighth Procuratorate of the Supreme People's Procuratorate that summarizing and deepening the special supervision and handling of cases and promoting the construction of relevant mechanisms has been listed as one of the important tasks this year.
Why did boxes of "elimination" antibacterial preparations arouse the common concern of procuratorial organs at all levels across the country? What are the characteristics of such cases? What are the problems and weaknesses in production, sales, supervision, etc.? What are the key links in case handling? With these questions in mind, the reporter interviewed a team of front-line prosecutors who have handled such cases.
Illegal addition of preparations is widespread
"The baby was just ten months old, and after applying the 'Seven Grasses and Two Leaves Antibacterial Ointment' cream, the effect was quite good at first, and the child grew a beard after using it for a while." In early January 2021, a mother from Ziyun Miao Buyi Autonomous County, Anshun City, Guizhou Province, reported the situation to Hu Lingling, a prosecutor from the Second Procuratorate Department of the Ziyun County People's Procuratorate.
"The doctor diagnosed that the child's problem was caused by the hormones contained in the cream, so I was worried about the long-lasting adverse effects on the child." The child's mother said anxiously.
At noon on the day they received the clue, Ban Jihuan and Zhang Qu, procurators of the Second Procuratorate Department, came to the child's home. Zhang Qu recalled to reporters: "The case handling team were all young 'parents and parents', and they all felt very worried after seeing the children, and immediately launched an investigation. ”
The antibacterial cream involved in the case was a "consumer" brand product, purchased from a chain store of maternal and baby products. After questioning the seller and the agent, the prosecutor in charge of the case found that they could not provide the "Product Inspection Report" and did not know whether it contained illegal ingredients.
Why does a two-day antibacterial cream have such a big impact on the baby? When the prosecutor obtained the quantitative test report of the antibacterial cream involved in the case, he found that the product added the prohibited ingredient clobetasol propionate exceeded the standard by more than 100 times.
This case is one of the typical cases of food and drug safety public interest litigation issued by the Supreme People's Procuratorate in 2022, and the antibacterial cream in the case is an antibacterial (antibacterial) preparation with the name "elimination", which involves illegal addition.
In another typical case in the same batch, the Jiangshan Municipal People's Procuratorate in Zhejiang Province carried out administrative public interest litigation supervision over the illegal addition of pharmaceutical ingredients to "elimination" products such as antibacterial preparations.
Yan Liang, director of the Fifth Procuratorial Department of the Jiangshan Municipal Procuratorate, said that according to the clues of the problem of "elimination" antibacterial preparations reported by the masses, the case-handling team conducted rapid tests on 23 antibacterial preparations such as a special antibacterial cream for children and a cool spray sold on the market, and found that 21 of the preparations were positive for prohibited substances such as glucocorticoids, ketoconazole, and metronidazole, and the label instructions of 3 preparations involved disease treatment.
The Jiangshan Municipal Procuratorate also sampled 21 antibacterial preparations on the market and commissioned the laboratory of the Supreme People's Procuratorate Technical Information Research Center for qualitative testing. After testing, the failure rate of 21 samples was 71.4%.
"The proportion of products containing illegally added ingredients is large, and such products add prohibited ingredients arbitrarily and in large quantities, and there are also problems such as multiple illegal additions at the same time, and product labels are not true." Yan Liang said.
In the first half of 2022, the Supreme People's Procuratorate Technical Information Research Center conducted inspection and identification of 38 test samples in 155 cases of illegal addition of drugs to antibacterial preparations. The identification results also show that illegal addition of chemical drugs in antibacterial (inhibitory) preparations and non-compliance with the requirements of the label are more common.
Supervise and strengthen the supervision of shelves around the masses
"The antibacterial preparations of the 'elimination' brand are mostly prescription drug ingredients such as hormones and antibiotics that are illegally added to chemical drugs." Mao Minyan, assistant procurator of the Fifth Procuratorial Department of the Jiangshan City Procuratorate, said.
"Using Chinese medicinal materials as raw materials to extract ingredients has a slow onset of action and high cost, while direct addition of banned pharmaceutical ingredients has a fast effect, good effect and low cost, which has become the main reason for illegal addition by bad producers." Yan Liang briefed reporters on the situation found in the handling of the case.
According to the prosecutor handling the case, the "consumer" products with the problem of illegal addition are sold in pharmacies, supermarkets, mother and baby stores, and even confinement centers. The reporter noticed that such products are mainly creams, as well as creams, gels and other types.
"The current group of antibacterial preparations is from infants to the elderly." Mao Minyan said that if pharmaceutical ingredients are added in violation of regulations, it is easy to trigger allergic reactions, resulting in a series of side effects such as drug-resistant strains, affecting water and salt metabolism, and even seriously endangering the physical development and human health of infants and young children.
What are the weaknesses in the administrative supervision process for such issues? Yan Liang said that at present, the "consumer" brand products adopt a filing system, the threshold is low, and manufacturers only need to submit a health and safety evaluation report for filing before listing. In the daily supervision regulations, the regulatory authorities have low requirements for the number of sampling and sample size; Sampling is mainly aimed at indicators such as effectiveness, and there are few sampling items for illegally added species. In this way, "consumer" products containing illegally added ingredients entered the market and appeared on the shelves around the masses.
During the handling of the case, the Jiangshan Municipal Procuratorate put forward procuratorial suggestions to the Jiangshan Municipal Health Bureau, urging it to investigate and deal with 14 pharmacies and medical institutions suspected of selling illegal disinfection products in accordance with the law, and to standardize and rectify the anti-(inhibitory) bacteria disinfection product industry in its jurisdiction. After the Jiangshan Municipal Health Bureau removed all the products involved from the shelves, it transferred the relevant clues to the health administrative department where the corresponding manufacturer was located.
The Ziyun County Procuratorate issued a pre-litigation procuratorial recommendation for administrative public interest litigation to the county health bureau. After receiving the procuratorial recommendation, the bureau imposed administrative penalties on the chain stores involved in the case, ordering them to immediately stop selling and removing the cream in question, and imposing a fine. The Anshun Municipal People's Procuratorate immediately deployed a special action for public interest litigation of infant antibacterial preparations, promoted the health department to carry out special work on investigation and cleanup, and inspected 662 maternal and baby product stores, pharmacies and confinement centers in the city, and all unqualified products were removed from the shelves.
Food and drug safety is directly related to the health and life safety of the masses and is a major livelihood issue. In February 2022, the Eighth Procuratorate of the Supreme People's Procuratorate listed and supervised a number of leads in public interest litigation cases involving the illegal addition of antibacterial preparations to "consumer" products, and issued a notice requiring local procuratorial organs to step up investigation and collect evidence materials based on relevant clues, take multiple measures at the same time, urge administrative organs to perform supervision and management duties in accordance with the law, and pursue the civil liability of violators who intentionally violate the law and cause serious consequences.
Promote the linkage between the top and bottom to strengthen traceability governance
Sampling by the Jiangshan Municipal Procuratorate showed that the unqualified products involved 4 production enterprises in 13 provinces. Problem products are sold from the place of origin to all parts of the country, and while strengthening supervision on the market side, traceability governance has become a necessary link to cure the root cause.
In Yan Liang's view, strengthening the construction of the procuratorial organs' long-distance coordination mechanism and strengthening the traceability governance will effectively improve the overall quality and efficiency of case handling.
With the strong support of the higher procuratorate, the Ziyun County Procuratorate requested the procuratorate where the production enterprise was located to assist in the investigation, extending the "chain" of supervision. The regulatory authority where the manufacturer is located imposed administrative penalties on the manufacturer by confiscating illegal gains, imposing a fine of 10 times the value of the goods, and revoking the "Hygiene License for Disinfection Product Manufacturers", and ordered the immediate suspension of production, recall and destruction of the antibacterial cream involved in the case that has been marketed.
In June last year, the Supreme People's Procuratorate held a national conference on promoting the handling of public interest litigation cases by procuratorial organs, requiring procuratorial organs to focus on administrative public interest litigation and comprehensively use a variety of supervision methods. For enterprises with serious violations of the law, while urging administrative organs to strengthen supervision, explore the handling of civil public interest litigation cases. It is necessary to link up and down, coordinate left and right, and give full play to the advantages of the integrated procuratorial case-handling mechanism.
In the special supervision, the Jiangxi Provincial People's Procuratorate, the Provincial Health Commission, the Public Security Department, the Market Supervision Bureau, the Drug Administration and other units jointly signed the "Jiangxi Province Disinfection Products Industry Supervision Joint Conference Mechanism" to establish a departmental coordination and multi-party linkage supervision work pattern in the field of disinfection products. The hospital also promoted relevant departments to issue the "Guidelines for the Sampling of Antibacterial Preparations in Jiangxi Province" to further standardize the sampling and testing items and inspection procedures of antibacterial preparations of "Elimination".
Digital prosecution is also applied to surveillance work. The Xinwu District People's Procuratorate of Wuxi City, Jiangsu Province, relying on the existing public welfare damage risk prevention and control software, has developed an intelligent case-handling subsystem for "consumer" products. The prosecutor imported the information of the problematic preparation into the data template, linked the online sales platform of the pharmacy for digital comparison, and completed the investigation of more than 2000,<> retail pharmacies in Wuxi and neighboring cities within one day. Based on the problems found, the court formulated and issued consultation letters and procuratorial suggestions to relevant departments to urge the performance of their duties, strengthen supervision, and transferred clues to relevant procuratorial organs on cases outside their jurisdiction. (Rule of Law Daily)