Debund| Medical Health Law Information ( January 2023)

The legal team of Dabang Medical Health Law has long been focusing on legal services in the medical and health field, and is well versed in the main business models of the medical and health industry and the internal operation processes of the enterprise, so that it can provide all-round legal services for medical enterprise customers.
2023-01-10 15:56:23

Introduction to the legal team of Dabang Medical Health Law



The legal team of Dabang Medical Health Law has long been focusing on legal services in the medical and health field, and is well versed in the main business models of the medical and health industry and the internal operation processes of the enterprise, so that it can provide all-round legal services for medical enterprise customers.



Our customers include large and famous pharmaceutical enterprises, as well as small and medium-sized enterprises and start-ups in the life sciences and medical and health fields. Our business scope covers the main fields of life science and medicine and health industry, especially in the fields of intellectual property protection, technology introduction, equity investment, mergers and acquisitions, project financing, compliance review, criminal civil intersection, dispute resolution, etc. We have rich practical experience, and can provide high-quality legal services for customer needs.


Contents of this issue:


一、 Latest regulations


01、Notice of the State Administration of Traditional Chinese Medicine on Printing and Distributing the "Fourteenth Five Year Plan" for the Informatization Development of Traditional Chinese Medicine

02、The Comprehensive Department of the State Food and Drug Administration publicly solicited opinions on the Measures for the Administration of Drug Standards (Draft for Comments)

03、The Supreme People's Court issued opinions on strengthening judicial protection of intellectual property rights of traditional Chinese medicine

04、Announcement of the State Food and Drug Administration and the General Administration of Customs on Matters Related to the Administration of the Import and Export of Narcotic Drugs and Psychotropic Drugs

05、The General Department of the State Food and Drug Administration publicly solicited the opinions of the Regulations on the Protection of Traditional Chinese Medicine Varieties (Draft for Comments on the Revised Draft)

06、Opinions of the State Intellectual Property Office and the State Medical Security Bureau on Strengthening Intellectual Property Protection in the Field of Centralized Pharmaceutical Procurement



二、 Latest case


01、The Supreme People's Procuratorate announces typical cases of public interest litigation on drug safety

02、The case of Zhengzhou Small Drug Pharmaceutical Technology Co., Ltd. to bid up the price of ibuprofen tablets

03、Northeast Pharmaceutical Group Co., Ltd. will be fined 133 million yuan for selling drugs at high prices

04、The case of manufacturing and selling inferior drugs by Sichuan Zijinghua Pharmaceutical Co., Ltd

05、The case of Yushibi Trading (Shanghai) Co., Ltd. suspected of failing to comply with drug production quality management standards



一、 Latest regulations



1. Notice of the State Administration of Traditional Chinese Medicine on Printing and Distributing the "Fourteenth Five Year Plan" for the Informatization Development of Traditional Chinese Medicine


Document No.: GZYGCH [2022] No. 238

Issued by: State Administration of Traditional Chinese Medicine

Date of issue: December 5, 2022


According to the spirit of the Fourteenth Five Year Plan for National Economic and Social Development of the People's Republic of China and the Outline of the Vision Goals for 2035, the Fourteenth Five Year National Informatization Plan, the Fourteenth Five Year Plan for the Development of Traditional Chinese Medicine, the Fourteenth Five Year Plan for Promoting the Informatization of National Government Affairs, the Fourteenth Five Year Plan for Promoting the Informatization of National Government Affairs, and the Fourteenth Five Year Plan for the Informatization of National Health, The State Administration of Traditional Chinese Medicine has formulated the Fourteenth Five Year Plan for the Development of TCM Informatization.


The Plan mainly deploys four tasks: first, consolidate the foundation for the development of TCM informatization, and propose three specific measures to accelerate the upgrading of information infrastructure. Second, we will deepen digital services for the convenience and benefit of the people, and propose four specific measures to strengthen the intelligent construction of traditional Chinese medicine hospitals, promote the deep integration of traditional Chinese medicine health services and the Internet, optimize the health information platform of traditional Chinese medicine hospitals, and optimize the smart TCM medical consortium. Third, we will strengthen the governance of TCM data resources, and propose four specific measures to strengthen TCM government services and management, implement the national system of TCM comprehensive statistics, build a platform for TCM comprehensive statistical information, and promote the openness and sharing of TCM statistical data. The fourth is to promote the innovative application of TCM data resources, and propose specific measures in four aspects: accelerating the key digital technologies of TCM, helping improve the quality control of TCM, innovating the new mode of digital education of TCM, and promoting the digitalization of TCM culture.


(Source: State Administration of Traditional Chinese Medicine

http://www.matcm.gov.cn



2. The Comprehensive Department of the State Food and Drug Administration publicly solicited opinions on the Measures for the Administration of Drug Standards (Draft for Comments)


Issued by: General Department of the State Food and Drug Administration

Date of issue: December 14, 2022


Recently, the State Drug Administration issued the Measures for the Administration of Drug Standards (Draft for Comments) (hereinafter referred to as the Draft for Comments), and now solicits opinions from the society. The feedback will be ended on January 14, 2023.


There are nine chapters and 46 articles in the text of the Draft for Comments, which are divided into general provisions, management responsibilities, planning and project initiation, formulation and revision, approval and promulgation, implementation and abolition, local drug standards, supervision and management, and supplementary provisions. The key problems to be solved include six aspects: defining the general principles of drug standard management, defining the relationship between drug standards at different levels, and defining the responsibilities of all parties involved in drug standard work. Among them, in order to effectively respond to drug safety or public health emergencies, the Draft, on the basis of stipulating the regular procedures for the formulation and revision of national drug standards, opens a "green channel" to expedite the formulation or revision of national drug standards.


(Source: State Drug Administration

https://www.nmpa.gov.cn/



3. The Supreme People's Court issued opinions on strengthening judicial protection of intellectual property rights of traditional Chinese medicine


Document No.: Fa Fa [2022] No. 34

Issued by: Supreme People's Court

Date of issue: December 22, 2022


The Supreme People's Court formulates these Opinions in order to thoroughly implement the spirit of the 20th CPC National Congress, implement the major decisions and arrangements of the CPC Central Committee and the State Council on the revitalization and development of traditional Chinese medicine and the relevant requirements of the Outline for Building a Powerful Country with Intellectual Property Rights (2021-2035), comprehensively strengthen the judicial protection of intellectual property rights of traditional Chinese medicine, promote the inheritance of the essence, integrity and innovation of traditional Chinese medicine, and promote the high-quality development of the cause and industry of traditional Chinese medicine.


The Opinion is divided into three parts and has 16 articles in total. Specific provisions are made to strengthen the judicial function of judicial protection of intellectual property rights of traditional Chinese medicine and improve the judicial level. It covers the judicial protection of Chinese medicine patents, trade marks, trade secrets and state secrets, copyrights and related rights, resources of traditional Chinese medicine, varieties of traditional Chinese medicine and other fields, strengthens the maintenance of the order of fair competition in the Chinese medicine market, strengthens the protection of the legitimate rights and interests of innovative subjects of traditional Chinese medicine, and increases the punishment of violations of intellectual property rights of traditional Chinese medicine. Focus on the main areas and key issues of TCM, and provide clear guidance for judicial practice of intellectual property rights of TCM. In terms of strengthening patent protection of traditional Chinese medicine, the Opinions put forward that we should follow the law of development of traditional Chinese medicine, accurately grasp the characteristics of innovation of traditional Chinese medicine, and improve the rules of judicial protection of patents in the field of traditional Chinese medicine.


(Source: Supreme People's Court

https://www.court.gov.cn



4. Announcement of the State Food and Drug Administration and the General Administration of Customs on Matters Related to the Administration of the Import and Export of Narcotic Drugs and Psychotropic Drugs


Document No.: No. 115 in 2022

Issued by: General Administration of Customs, State Food and Drug Administration

Date of issue: December 22, 2022


In order to further deepen the reform of "releasing, controlling and serving", strengthen the import and export management of narcotic drugs and psychotropic substances, and promote the facilitation and standardization of cross-border trade of narcotic drugs and psychotropic substances, the State Food and Drug Administration and the General Administration of Customs issued relevant announcements in accordance with the Drug Administration Law of the People's Republic of China and the Regulations on the Administration of Narcotic Drugs and Psychotropic Substances.


The Announcement clearly states that the import and export of narcotic drugs and psychotropic drugs shall be subject to the import license and export license issued by the State Food and Drug Administration. The import of narcotic drugs and psychotropic drugs does not need to go through the customs declaration form for imported drugs. According to the Announcement, the State Food and Drug Administration simultaneously issues import and export electronic permits and paper certificates, which have the same legal effect. The customs shall check and approve the electronic certificate of license through online verification, and no paper endorsement is required. According to the Announcement, the import license is valid for one year and can be used across natural years; The period of validity of the export license shall not exceed 3 months, and the period of validity shall not exceed a natural year. Import and export licenses are subject to "one license and one customs clearance", and can only be used once within the validity period.


(Source: State Drug Administration

https://www.nmpa.gov.cn/



5. The General Department of the State Food and Drug Administration publicly solicited the opinions of the Regulations on the Protection of Traditional Chinese Medicine Varieties (Draft for Comments on the Revised Draft)


Issued by: General Department of the State Food and Drug Administration

Date of issue: December 22, 2022


In order to strengthen the whole life cycle management of traditional Chinese medicine varieties and promote the continuous improvement of the quality of traditional Chinese medicine varieties, the State Food and Drug Administration has organized the drafting of the Regulations on the Protection of Traditional Chinese Medicine Varieties (Draft for Comments on the Revised Draft), which is now open to the public for comments. The time for public consultation is from December 25, 2022 to January 24, 2023.


The Draft has seven chapters and 44 articles, and the framework structure has been greatly adjusted, mainly including general provisions, protection scope and protection level, application and approval, holders of certificates of protected varieties of traditional Chinese medicine, supervision and management, legal liability, and supplementary provisions. Among them, the scope, mode and level of protection in Chapter II are the core of the system of traditional Chinese medicine protection varieties, and this revision has been greatly improved. The Draft for Comments divides the protection of traditional Chinese medicine varieties into three levels. The first level protection is given a 10-year market monopoly, the second level protection is given a five-year market monopoly, the first level protection and the second level protection are given special marks for the protection of traditional Chinese medicine varieties at the same time, and the third level protection is only given a five-year special mark for the protection of traditional Chinese medicine varieties. At the same time, the system of extending the protection period will be cancelled to promote the innovation of traditional Chinese medicine varieties and the continuous improvement of the listed varieties, and avoid "one guarantee for ever".


(Source: State Drug Administration

https://www.nmpa.gov.cn/



6. Opinions of the State Intellectual Property Office and the State Medical Security Bureau on Strengthening Intellectual Property Protection in the Field of Centralized Pharmaceutical Procurement


Document No.: GZFBZ [2022] No. 45

Issued by: State Intellectual Property Office, State Medical Security Bureau

Date of issue: December 30, 2022


In order to thoroughly implement the decision and deployment of the CPC Central Committee and the State Council on comprehensively strengthening intellectual property protection, implement the State Council's decision to further improve the intellectual property protection mechanism for centralized procurement of pharmaceutical products, build a coordinated and unified information sharing mechanism, prevent infringement from the source, encourage innovative development in the pharmaceutical field, and optimize the business environment, In combination with the cooperation foundation of the intellectual property system and the medical security system in the intellectual property protection and centralized procurement of medicine, the State Intellectual Property Office and the State Medical Security Bureau jointly put forward opinions on the protection of intellectual property rights in the field of centralized procurement of medicine.


The Opinions pointed out that the State Intellectual Property Office and the State Medical Security Bureau have established a coordination and consultation mechanism for intellectual property protection in the pharmaceutical field. According to the needs of the work, a meeting was organized to propose relevant countermeasures and measures for the key and hot issues of intellectual property protection in the pharmaceutical field. The Opinions emphasized that we should do a good job in guiding dispute resolution. In the process of centralized volume purchase or online purchase, if there is a patent infringement dispute, the pharmaceutical centralized purchasing agency can inform the relevant parties to request the intellectual property management department for handling or file a lawsuit with the people's court. The Opinions requires that we should pay special attention to the products involving intellectual property risk in the drugs and medical consumables that are planned to be purchased in large quantities and with high attention.



二、 Latest case


1. The Supreme People's Procuratorate announced typical cases of public interest litigation on drug safety


On December 14, 2022, the Supreme People's Procuratorate issued the Notice on Printing and Distributing the Typical Cases of Public Interest Litigation on Drug Safety, announcing the cases:


1) The People's Procuratorate of Zhijin County, Guizhou Province urged to rectify the administrative public interest litigation case of expired drugs

On March 16, 2021, the People's Procuratorate of Zhijin County, Guizhou Province (hereinafter referred to as the People's Procuratorate of Zhijin County) found in the work of special public interest litigation on drug safety that there were a large number of expired drugs in a health room in Guanzhai Miao Township, Zhijin County, which did not dispose of according to the relevant provisions on the management of expired drugs, damaging the social and public interests.

Zhijin County Hospital issued a procuratorial proposal to the Zhijin County Health Bureau and the Market Supervision and Administration Bureau according to law, suggesting that the Zhijin County Health Bureau deal with the problem of expired drugs in a clinic in Guanzhai Township, Zhijin County according to law, and take effective measures to conduct a comprehensive screening of rural clinics and private clinics within the jurisdiction, and standardize rural medical institutions. It is suggested that the Market Supervision and Administration Bureau of Zhijin County should perform its regulatory duties on illegal sales of expired drugs according to law, carry out a comprehensive investigation, and standardize drug business. After receiving the procuratorial suggestions, the Zhijin County Health Bureau and the Market Supervision and Administration Bureau promptly investigated and dealt with the case, imposed administrative penalties on the offenders involved, and established a working group to carry out special inspections on relevant drug use institutions throughout the county. A total of 354 health centers, village clinics, clinics and private hospitals were inspected. Eight health centers with expired drugs were given administrative punishment of warning according to law, and all expired drugs were destroyed.


2) The People's Procuratorate of Huichang County, Jiangxi Province urged the rectification of illegal operation of Chinese herbal medicine shops

More than ten Chinese herbal medicine shops in Huichang County, including "Herbal Shop of Bencao Hall", "Roche Folk Chinese Herbal Medicine Shop", "Chenji Chinese Herbal Medicine Shop", "Huichang County Folk Chinese Herbal Medicine Shop", "Ancestral Folk Chinese Herbal Medicine", "Grain Art Herbal Medicine", and "Convenient Chinese Herbal Medicine", have operated beyond the scope of business or without certificates, engaged in diagnosis and treatment activities without obtaining the qualification of traditional Chinese medicine doctors, and falsely publicized and sold self-made ointment without batch number, Disturb the market order, endanger the health of unspecified consumers, and damage the public interest.

On August 18, 2021, the People's Procuratorate of Huichang County, Jiangxi Province (hereinafter referred to as Huichang County People's Procuratorate) decided to file a case for investigation after finding the clues of the case according to the reports of the masses, formed a case handling team, and invited professionals from the market supervision and comprehensive law enforcement department to serve as specially invited assistant prosecutors to participate in the case handling. On September 2 of the same year, in view of the illegal operation of Chinese herbal medicine stores and other issues, Huichang County People's Court issued a pre litigation procuratorial proposal to the County Market Supervision and Administration Bureau and the County Health Committee respectively, suggesting that the Market Supervision and Administration Bureau perform its duties of food and drug supervision and administration according to law, and investigate and deal with the illegal operation of the stores involved in the case; It is suggested that the Health Commission should perform its regulatory duties according to law, and investigate and deal with the illegal acts of the operators involved in the case of carrying out TCM diagnosis and treatment activities without certificates; It is also suggested that the two units, together with other administrative organs, conduct a comprehensive screening of Chinese herbal medicine stores within their jurisdiction according to law, and jointly standardize the Chinese medicine market.


3) The People's Procuratorate of Haiyan County, Zhejiang Province urged the rectification of the administrative public interest lawsuit on the sale of fake Chinese medicines

In July 2021, Qian was registered and established as a "Qian's Health Preserver". By hanging a banner and distributing business cards, he claimed that he was the vice president of a medical college in Beijing, a Chinese medical rehabilitation therapist, and a Qigong master. He could treat elderly diseases such as hyperosteogeny and rheumatoid arthritis, attract elderly people to come into the store for conditioning, and use the terms "activating stem cells", "regenerating tissue cells", and other terms to make up product functions, The elderly were tricked into buying "Joint Regeneration Capsule" (the drug was identified as fake) for treatment, which infringed on consumer rights and social public interests.

In December 2021, the People's Procuratorate of Haiyan County, Zhejiang Province (hereinafter referred to as Haiyan County People's Procuratorate) received a clue from the masses to report that Qian sold counterfeit Chinese medicine. Haiyan County Hospital quickly set up a case handling team to carry out investigation and evidence collection from the aspects of doctor qualification, drug quality, public welfare damage status, etc. After receiving the procuratorial advice, Haiyan County Market Supervision and Administration Bureau attached great importance to it and immediately set up a working group to conduct a surprise law enforcement inspection on Qian's Health Preserve. More than 3000 "joint regeneration capsules" were seized and detained on the spot, and the clues of Qian's suspected crime were transferred to the public security organ on the same day. At present, Qian has been investigated by the public security organ on suspicion of selling counterfeit drugs and taken criminal coercive measures.


4) Administrative Public Interest Litigation Case of Chongqing Xiushan Tujia and Miao Autonomous County People's Procuratorate Urged to Rectify the Illegal Operation of the Medical and Aesthetic Industry

Many self-employed businesses in Xiushan County, Chongqing, whose business scope is beauty, body beauty, eyelash beauty, nail beauty, embroidery services and daily chemical products sales, provide facial injection of botulinum toxin (commonly known as face slimming needle) without obtaining the medical institution license according to law. Improper use or use of botulinum toxin A for injection without approval may cause muscle relaxation and paralysis, In severe cases, it may cause respiratory failure and heart failure, endangering the health of consumers.

In May 2020, the People's Procuratorate of Xiushan Tujia and Miao Autonomous County of Chongqing (hereinafter referred to as Xiushan County People's Procuratorate) will file a case on May 11, 2020 after receiving the clues from the masses. After visiting and investigating, the Public Interest Litigation Department found that beauty shops and nail salons in the jurisdiction did not obtain corresponding qualifications according to law, provided medical beauty services beyond the scope, used medical devices in violation of regulations, used drugs such as botulinum toxin A for injection without approval, and made false publicity. On July 2, 2020, The market supervision and administration bureau of Xiushan County and the health committee of Xiushan County were respectively advised to investigate and regulate the illegal use of medical devices, drugs not approved for marketing, and false publicity; Second, establish a long-term mechanism to standardize the plastic surgery market in Xiushan County.

After receiving the procuratorial advice, Xiushan County Market Supervision and Administration Bureau and the County Health and Health Commission attached great importance to it and jointly carried out the special rectification work of medical beauty, strictly investigated and dealt with illegal medical beauty behaviors according to law. A total of 24 beauty agencies were inspected, 24 health supervision opinions were issued, 8 cases were filed, more than 18000 yuan was fined, 4 devices were confiscated, and the illegal income was 23122.8 yuan.


5) Administrative Public Interest Litigation Case of Beijing Railway Transport Procuratorate Urged and Regulated Illegal Sales of Prescription Drugs in Online Platform Drugstores

The Beijing Railway Transport Procuratorate (hereinafter referred to as the Beijing Railway Inspection Institute) found in the performance of its duties that the licensed pharmacists of some online platform pharmacies entered the offline distribution link without reviewing the electronic prescriptions in accordance with relevant laws and regulations in the electronic prescription review link after receiving the online drug purchase order, and there were illegal acts such as still dispensing the over-dosage prescription drugs and not signing the prescriptions, which may cause the problem of drug safety for the people, Damage the public interest.

Beijing Railway Inspection Institute decided to file the case for investigation in September 2021. The public interest litigation procuratorial department will focus on the investigation of pharmacies registered in Beijing on the network platform and those registered in Beijing on the network platform outside Beijing, and comprehensively understand the sales of online prescription drugs through big data screening, manual review, sorting and analysis. Through investigation, it was found that 28 pharmacies registered in Beijing on 3 online platforms (including 2 online platforms registered in Beijing) failed to perform the review responsibility of electronic prescriptions according to law, involving 5 administrative regions.

In September and November 2021, Beijing Railway Inspection Institute issued inspection suggestions to the drug regulatory authorities in five districts, urged the administrative authorities to investigate and deal with the illegal acts involved in the case, and strengthened supervision over the performance of electronic prescription review responsibilities of licensed pharmacists in online platform pharmacies, and standardized the online sales of prescription drugs.


6) Kunming Railway Transport Branch of Yunnan Provincial People's Procuratorate Urged the Rectification of Drug Advertisement False Publicity Administrative Public Interest Litigation Case

The law clearly stipulates that prescription drugs may be advertised in medical and pharmaceutical professional journals jointly designated by the Ministry of Health and the State Food and Drug Administration, but they may not be advertised in mass media or advertised in other ways to the public. The relevant columns of news comprehensive broadcasting of Kunming Radio and Television Station have been illegally broadcasting prescription drug advertisements for a long time, and the content of relevant drug advertisements is false, which is very easy to induce consumers to have a wrong understanding of drug use, causing potential drug safety problems for the masses and damaging social and public interests.

The Kunming Railway Transport Branch Office of Yunnan Provincial People's Procuratorate (hereinafter referred to as Kunming Railway Inspection Branch Office) decided to file a case for investigation on February 9, 2021 on the basis of preliminary investigation. In accordance with the relevant provisions of the Drug Administration Law of the People's Republic of China, the Standards for the Examination and Release of Drug Advertisements, the Measures for the Examination of Drug Advertisements, the Advertising Law of the People's Republic of China, and the Anti unfair Competition Law of the People's Republic of China, Kunming Municipal Market Supervision and Administration Bureau is responsible for the supervision and administration of illegal advertising and false publicity of prescription drugs and over-the-counter drugs through the comprehensive news broadcast of Kunming Radio and Television Station.

Kunming Municipal Market Supervision and Administration Bureau attached great importance to the case after receiving the procuratorial advice, and made timely rectification and implementation: first, it ordered Kunming Radio and TV Station to stop broadcasting illegal advertisements for prescription drugs and illegal and false advertisements for non prescription drugs; Second, on May 14, the prescription drug advertisers were transferred to the Qinghai Provincial Market Supervision and Administration Bureau for investigation and punishment for suspected violations; Third, a science and technology development limited company affiliated to Kunming Radio and TV Station, which is the publisher of illegal prescription drug advertisements, was put on file for investigation. On August 19, 2021, an administrative penalty was imposed on it, with 1200 yuan of advertising expenses confiscated and a fine of 203600 yuan imposed, which has been paid in full; Fourth, a pharmaceutical company in Yunnan Province, the advertiser of the false advertisement of OTC drugs, was fined three times of the advertising fee, totaling 15000 yuan. A science and technology development company affiliated to Kunming Radio and TV Station, the advertisement publisher, confiscated 5000 yuan of the advertising fee, and concurrently fined 15000 yuan three times of the advertising fee, all of which have been paid in full.


7) Administrative Public Interest Litigation Case of Puyang People's Procuratorate of Henan Province Urged the Rectification of Illegal Mailing of Fake and Inferior Drugs

From September 2017 to December 2020, many offenders in Puyang City, Henan Province, mailed fake and inferior drugs through a express company in Taiqian County, a express company in Hualong District and other terminal outlets, and sold them to many regions across the country. According to statistics, fake and inferior drugs were mailed more than 3000 times, with a sales amount of more than 1 million yuan. The fake and inferior drugs entered the consumer market through the circulation of the mailing industry, which not only damaged the market economic order, It also harms the personal health rights and interests of many consumers.

The People's Procuratorate of Taiqian County, Puyang City, found that the postal administration may have inadequate supervision over the delivery of drugs in the process of handling a number of criminal incidental civil public interest litigation cases related to the sale of fake and substandard drugs, so it handed the clue over to the People's Procuratorate of Puyang City (hereinafter referred to as Puyang Municipal People's Procuratorate). On February 8, 2021, Puyang Municipal People's Court filed an administrative public interest lawsuit.

On July 26 of the same year, the Municipal Postal Administration replied in writing to impose administrative penalties on the enterprises involved in the case; Formulated and implemented the special rectification work plan for illegal sending and delivering counterfeit drugs; Conduct special training for employees in the mail and delivery industry; Together with the Municipal Public Security Bureau, the Municipal Drug Control Commission and the Municipal National Security Bureau, the relevant documents on the security of the delivery channel were printed and issued, forming a long-term mechanism to jointly combat the delivery of counterfeit drugs and other items, and jointly building a security barrier for the delivery channel.


8) The People's Procuratorate of Xinyi City, Jiangsu Province sued Xue Moumou and other six people for selling counterfeit drugs, and the case of criminal incidental civil public interest litigation

From 2017 to 2019, six people including Xue bought a large number of "traditional Chinese medicine capsules" with the main ingredients of flour and western medicine illegally processed and produced from Cao and others through online channels, and sold them to unspecified elderly groups through pharmacies and clinics they operated to treat asthma, arthritis and other diseases. After investigation, Xue and others sold more than 5000 bottles to more than 2000 people, with a sales volume of 116200 yuan. The above drugs were identified as fake drugs. On June 22, 2021, the public security organ transferred six people, including Xue, to be investigated and prosecuted for the crime of producing and selling counterfeit drugs.

On October 15, 2021, the People's Procuratorate of Xinyi City, Jiangsu Province (hereinafter referred to as the Xinyi Municipal People's Procuratorate) filed an investigation into Xue and others' criminal incidental civil public interest litigation. On January 10, 2022, Xinyi Municipal People's Court made a criminal judgment of first instance, all of which adopted the sentencing recommendations of the procuratorial organ, sentenced the six defendants to fixed-term imprisonment ranging from six months to one year, and imposed a fine ranging from 1000 yuan to 200000 yuan, all of which were subject to probation. On January 19, 2022, Xinyi Municipal People's Court made a judgment of first instance of incidental civil public interest litigation, fully supporting the procuratorial organ's request for incidental civil public interest litigation. The defendant did not appeal, and the judgment has come into force.



2. The case of Zhengzhou Small Drug Pharmaceutical Technology Co., Ltd. to bid up the price of ibuprofen tablets


On December 27, 2022, the law enforcement inspection detachment of Zhengzhou Municipal Market Supervision Bureau investigated and dealt with Zhengzhou Small Drug Pharmaceutical Technology Co., Ltd. (hereinafter referred to as "Small Drug Company") according to law. Small drug companies used the online "Drug Help" App wholesale platform to bid up the price of ibuprofen tablets to pharmaceutical retailers, pharmacies and clinics across the country in B2B mode. After two price increases, the price of ibuprofen tablets sold by them rose from 2.33 yuan/bottle to 2.43 yuan/bottle on December 10, 2022 to 19.8 yuan/bottle from December 17, 2022 to December 24, 2022. The number of drugs involved reached 30600 bottles, which directly led to a large number of terminal drug retail enterprises and medical institutions to significantly increase the price of related drugs, disrupted the market price order of epidemic related materials, and had a bad social impact. After investigation, it was found that small drug companies raised the sales price by a large margin without changing the purchase cost, which was suspected to constitute an illegal act of driving up the price. At present, the case has been investigated and ended.


On December 29, 2022, Zhengzhou Municipal Market Supervision Bureau, in accordance with the relevant provisions of the Price Law of the People's Republic of China and the Provisions on Administrative Penalties for Price Violations, and taking into account the facts, circumstances and social hazards of their violations, has ordered small drug companies to make corrections immediately, served them with a notice of administrative penalties, and proposed to give small drug companies a warning and a fine of 2.6 million yuan.



3. High price drug sales case of Northeast Pharmaceutical Group Co., Ltd


On December 9, 2022, Northeast Pharmaceutical Group Co., Ltd. received the Notice of Administrative Punishments issued by the Liaoning Provincial Market Supervision Administration. During the period from November 2018 to June 2019, it sold levocarnitine at an unfair high price, which violated the provisions of the Anti monopoly Law of the People's Republic of China (hereinafter referred to as the Anti monopoly Law) and constituted an act of abusing the dominant market position to sell goods at an unfair high price. According to the provisions of the Anti monopoly Law and the Administrative Punishment Law before the amendment, the Liaoning Provincial Market Supervision and Administration Bureau plans to impose a fine of 2% of the company's domestic sales in 2018, totaling 133 million yuan.



4. The case of manufacturing and selling inferior drugs by Sichuan Zijinghua Pharmaceutical Co., Ltd


On December 27, 2022, Sichuan Provincial Drug Administration released the "Sichuan Drug Administration Penalty Decision [2022] No. 1036" administrative punishment decision, which showed that the prepared Chinese medicine Dangshen (batch number: 210901) produced and sold by Sichuan Zijinghua Pharmaceutical Co., Ltd. was subject to supervision and sampling inspection, and it was found that the residual sulfur dioxide content was 1149mg/kg (should not exceed 400mg/kg), which did not meet the requirements of the Standard for Preparation of Chinese Medicine Slices in Sichuan Province (2015 version); According to the supervision and sampling inspection of the prepared slices of Dictamnus dasycarpus (batch number: 210301), the property item "partially without removing the wood core" does not meet the requirements of the first standard of the Chinese Pharmacopoeia (2020 edition).


Through investigation, the illegal income of the above two batches of products totaled 205381.5 yuan, and the value of goods was 205381.5 yuan. According to Article 117 of the Drug Administration Law of the People's Republic of China, Sichuan Provincial Drug Administration issued a warning to Sichuan Bauhinia Pharmaceutical Co., Ltd., confiscated the illegal income of 205381.5 yuan and fined 305955 yuan. The above fines and confiscations totaled 511336.5 yuan. The punishment decision date is December 9, 2022.



5. The case of Yushibi Trading (Shanghai) Co., Ltd. suspected of failing to comply with drug production quality management standards


On December 27, 2022, the Shanghai Municipal Drug Administration issued the decision on administrative penalty of "H.D.J.J.C. [2022] No. 762022000052". The holders of drug marketing license, drug manufacturers, drug distributors, drug non clinical safety evaluation and research institutions, drug clinical testing institutions, etc. of USBE Trading (Shanghai) Co., Ltd. failed to comply with the drug production quality management standards, drug trading quality management standards Non clinical drug research quality management specifications, clinical drug trial quality management specifications, etc.


From July 4 to 8, 2022, the Food and Drug Audit and Inspection Center of the State Food and Drug Administration organized an overseas off-site inspection of UCBPharma S.A. (hereinafter referred to as UCB Company), and found that some batches of levetiracetam concentrated solution for injection (batch numbers: 21073, 22001, 22004, 22006) had inconsistent validity periods with those approved by registration.


From June 2021 to April 2022, UCB Company will produce 4 batches of the above drugs (615.6L in batch), totaling 22725 boxes (10 bottles/box), of which the batch number is 21073, totaling 5625 boxes, the batch number is 22001, totaling 1100 boxes, the batch number is 22004, totaling 5025 boxes, and the batch number is 22006, totaling 10975 boxes. From April 9 to June 30, 2022, UCB will sell all the above drugs to the parties concerned. The validity period indicated in the instructions of the above four batches of drugs is 36 months, and the information of "production date" and "expiry date" on the outer package shows that the validity period is 36 months, which is inconsistent with the 18 months in the notification of approval of supplementary drug application. When UCB Company produced the above four batches of drugs, it used the outer packaging and instructions with a validity period of 36 months, failed to provide the entrusted manufacturer and packaging plant with all the relevant information about the new batch 615.6L, and failed to ensure that the validity period of printing packaging materials for the new batch 615.6L was consistent with the content specified in the approval notice of drug replenishment application; The relevant change documents of UCB Company have not been revised. Before the production of the above four batches of drugs, the contents of the 18 month validity period in the relevant production quality management documents of the new batch 615.6L have not been revised, including the quality standards; Before approving the release of the above four batches of drugs, UCB did not confirm that the change of the validity period had been handled. From July 12 to August 3, 2022, the parties involved recalled the above four batches of drugs.


Shanghai Drug Administration will impose an administrative penalty of 1.2 million yuan in accordance with Article 126 of the Drug Administration Law of the People's Republic of China.