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、Guiding Opinions of the Comprehensive Department of the State Food and Drug Administration on Strengthening the Hierarchical Supervision of the Production and Operation of Medical Devices

02、Opinions on Further Strengthening the Investigation and Handling of Drug Cases

03、Notice of Shandong Drug Administration and Shandong Health Commission on Printing and Distributing Shandong Drug Use Quality Management Standards

04、Announcement of the State Food and Drug Administration on Encouraging Enterprises and Social Third Parties to Participate in the Formulation and Revision of Standards for Traditional Chinese Medicine

二、 Latest case

01、Hainan Provincial Market Supervision Bureau Announces Typical Cases of Anti unfair Competition Law Enforcement in 2022

02、Two pharmaceutical companies in Anhui were punished for failing to meet the requirements of drug GMP

03、Wuxi Hua'ao Pharmaceutical Co., Ltd.'s case of producing and selling inferior drugs

04、Panjin Taixing Materials Comprehensive Co., Ltd. made medical oxygen inspection record

三、 Professional Articles

01、Research on Tax related Crimes of Entrepreneurs in the Yangtze River Delta - Empirical Analysis Based on Judicial Cases (Original by Bai Lituan)

一、 Latest regulations

1. Guiding Opinions of the Comprehensive Department of the State Food and Drug Administration on Strengthening the Hierarchical Supervision of the Production and Operation of Medical Devices

Document No.: YJZXG [2022] No. 78

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

Date of issue: September 9, 2022

In order to implement the Regulations on the Supervision and Administration of Medical Devices, implement the requirements of the Measures for the Supervision and Administration of Medical Device Production and the Measures for the Supervision and Administration of Medical Device Business, further strengthen the supervision of medical device production and operation, scientifically and rationally allocate regulatory resources, ensure the safety and effectiveness of medical devices according to law, promote the new improvement of the quality and safety level of medical devices, put forward general requirements, carry out hierarchical supervision of medical device production Guidance on carrying out hierarchical supervision of medical device operation, strengthening supervision and management, and improving supervision efficiency.

In the general requirements, it is proposed to earnestly implement the requirements of the Regulations on the Supervision and Administration of Medical Devices, the Measures for the Supervision and Administration of the Production of Medical Devices, and the Measures for the Supervision and Administration of the Operation of Medical Devices. In accordance with the principle of "risk classification, scientific supervision, comprehensive coverage, dynamic adjustment, responsibility implementation, and efficiency improvement", we should carry out the hierarchical supervision of the production and operation of medical devices, and strengthen the supervision responsibilities of drug regulatory authorities at all levels, We will establish and improve a scientific and efficient regulatory model, strengthen the supervision and management of the production and operation of medical devices, and ensure the safety of people's equipment.

In the implementation of hierarchical supervision of medical device production, it is proposed to implement the responsibility of hierarchical supervision of production, determine the catalog of key supervision varieties based on the actual situation, formulate detailed regulations on hierarchical supervision, dynamically adjust the level of supervision, and strengthen supervision and inspection according to the level of supervision.

In carrying out hierarchical supervision of medical device operation, we should implement the responsibility of hierarchical supervision of operation, determine the list of key regulatory varieties based on the actual situation, formulate detailed regulations on hierarchical supervision, dynamically adjust the level of supervision, and strengthen supervision and inspection according to the level of supervision.

To strengthen supervision and management and improve supervision efficiency, it is required to strengthen organizational leadership, strengthen problem handling and strengthen capacity building.

(Source: State Drug Administration

https://www.nmpa.gov.cn/ ）

2. Opinions on Further Strengthening the Investigation and Handling of Drug Cases

Issued by: State Drug Administration and State Administration of Market Supervision and Administration

Date of issue: September 28, 2022

The State Food and Drug Administration and the State Administration of Market Supervision jointly issued the Opinions on Further Strengthening the Investigation and Handling of Drug Cases, which strengthened the norms and guidance for the investigation and handling of cases, improved the mechanism for the investigation and handling of cases, implemented drug safety responsibilities, and severely punished illegal and criminal acts in the fields of drugs, medical devices, and cosmetics.

The Opinions made a comprehensive arrangement for the investigation and handling of cases from four aspects, and required drug regulatory authorities at all levels to establish a case investigation and handling mechanism with clear responsibilities, legal order, scientific and reasonable, and close connection. The Opinions clearly stated that regulatory authorities at all levels should establish the concept of law enforcement and case handling in the new era, scientifically divide the power of case investigation, reasonably allocate the resources for case investigation, strengthen the coordination and linkage of case investigation and handling, and take more resolute and powerful measures to strictly investigate and deal with all kinds of drug violations. The Opinions emphasized that we should actively investigate the clues of cases, standardize the procedures of case investigation and evidence collection, strictly implement administrative punishment, standardize the discretion of administrative punishment, and continuously improve the efficiency of case investigation and handling in response to the outstanding problems strongly reflected by the masses. The Opinions require that we strictly implement the rule of "punishing individuals" for illegal acts, improve the mechanism for linking the execution of sentences, comprehensively plan the risk prevention and control of major cases, steadily promote the disclosure of case investigation information, timely take effective risk control measures, and comprehensively improve the transparency, standardization and credibility of law enforcement. The Opinions proposed to strengthen the coordination and linkage of inspection and inspection, strengthen the supervision and handling of cases, strengthen the assessment and evaluation of case investigation and handling and other measures, improve the quality and ability of case investigation and handling cadres, and create a good atmosphere to encourage supervision and law enforcement personnel to be brave, responsible and strict in law enforcement.

(Source: State Drug Administration

https://www.nmpa.gov.cn/ ）

3. Notice of Shandong Drug Administration and Shandong Health Commission on Printing and Distributing Shandong Drug Use Quality Management Standards

Document No.: LDJG [2022] No. 8

Issued by: Shandong Drug Administration, Shandong Health Commission

Date of issue: August 26, 2022

Implementation date: October 1, 2022

In order to standardize the quality management of drug use in our province and ensure the safety and effectiveness of public drug use, this specification is formulated in accordance with the provisions of laws and regulations such as the Drug Administration Law of the People's Republic of China, the Implementation Regulations of the Drug Administration Law of the People's Republic of China, and the Shandong Drug Use Regulations.

This specification is applicable to the quality management of the purchase, storage and distribution of the following drugs for drug users in the administrative region of the province: medical institutions; Disease prevention and control institutions, health care institutions and drug rehabilitation institutions; Other drug users.

When purchasing drugs, drug users should, on the premise of ensuring the quality, purchase drugs from the holders of drug marketing licenses or enterprises with corresponding drug production and trading qualifications, except for the purchase of Chinese medicinal materials that have not been subject to examination and approval administration.

When purchasing drugs, the drug user must strictly review the qualification of the supplier, the purchased drugs and the sales personnel, establish the supplier's file, and ask for the following information: (1) The Drug Production License or Drug Trade License with the original seal of the supplier, and the business license, the form of documents accompanying the goods, the form of invoices, the form of seals, and the copies of the corporate account number; (2) A copy of the approval certificate of the sold drugs affixed with the original seal of the supplier; (3) The original power of attorney affixed with the original seal of the supplier and the seal (or signature) of the legal representative of the enterprise. The power of attorney shall specify the variety, region, term and ID card number of the salesperson authorized to sell drugs; (4) A copy of the ID card of the drug salesperson affixed with the original seal of the supplier; (5) The sales voucher issued by the supplier indicating the supplier's name, drug name, marketing license holder, manufacturer, batch number, quantity, price, etc. When purchasing imported drugs, in addition to the above materials, a copy of the Imported Drugs Customs Clearance Form affixed with the original seal of the supplier shall also be requested.

The electronic documents that meet the requirements for the information referred to in this article shall have the same effect.

The drug user shall establish a true and complete record of drug purchase acceptance, and ensure that the bills, accounts and materials are consistent. The drug purchase acceptance record shall include the generic name, dosage form, specification, production batch number, production date, validity period, marketing license holder, manufacturer, approval number, supplier, purchase quantity, purchase date, purchase price, acceptance conclusion, signature of the acceptor, etc. The retention period of the purchase acceptance records and relevant materials shall be one year after the expiration of the drug validity period; If the validity period of a drug is less than 2 years, the storage period shall not be less than 3 years; The retention period of the special account books for narcotic drugs and Class I psychotropic drugs shall not be less than 5 years from the date when the drugs expire.

Medical institutions accepting donated drugs and transferring first-aid drugs from other medical institutions shall implement the provisions of the preceding paragraph.

The drug users shall regularly check and assess the implementation of the management system to ensure drug quality, and make records.

(Source: Shandong Drug Administration

http://mpa.shandong.gov.cn/ ）

4. Announcement of the State Food and Drug Administration on Encouraging Enterprises and Social Third Parties to Participate in the Formulation and Revision of Standards for Traditional Chinese Medicine

Document No.: No. 70 in 2022

Issued by: State Drug Administration

Date of issue: September 6, 2022

In order to further enhance the management capacity of traditional Chinese medicine standards, establish the most rigorous standards, optimize the standard working mechanism, comprehensively build a new pattern of traditional Chinese medicine standard work under the guidance of the government, with enterprises as the main body, with social participation and open integration, and give full play to the important role of social forces in the standard work, the State Drug Administration has formulated the Announcement on matters related to encouraging enterprises and social third parties to participate in the formulation and revision of traditional Chinese medicine standards.

The Announcement proposes to encourage and support enterprises and social third parties to increase investment in information, technology, talents and funds in the research and improvement of TCM standards, and put forward reasonable opinions and suggestions on the formulation and revision of TCM standards. The Announcement clearly states that holders of drug marketing licenses, Chinese medicine manufacturers, consortia formed by enterprises and scientific research institutions, social organizations or independent social third parties can participate in the formulation and revision of Chinese medicine standards by "participating in or supporting the publicity, implementation, training, application and promotion of Chinese medicine standards and inspection technologies". The Announcement also pointed out that Chinese medicine manufacturers participating in the production validation of the draft standard of traditional Chinese medicine should carry out corresponding work according to the impact of the draft standard on drug safety, effectiveness, quality controllability and relevant technical requirements; Pharmaceutical manufacturers and technicians participating in the verification of standard production of traditional Chinese medicine shall have the corresponding qualifications and qualifications.

(Source: State Drug Administration

https://www.nmpa.gov.cn/ ）

二、 Latest case

1. Hainan Provincial Market Supervision Bureau Announces Typical Cases of Anti unfair Competition Law Enforcement in 2022

Since May 2022, Hainan Provincial Market Supervision Bureau has carried out the special law enforcement action against unfair competition in 2022 across the province, focusing on investigating and punishing various unfair competition behaviors in the areas of people's livelihood and new consumption, important commodity and factor markets, commercial marketing links and new economy. In order to guide and warn various market entities to consciously abide by the law and jointly maintain a unified, open, fair and orderly market environment, typical cases are announced as follows:

(1) False publicity case of a real estate development company in Hainan

On March 18, 2022, the law enforcement personnel found that the sales status of the houses indicated on the Sales Control Table of Commercial Houses hung in the sales hall of the party concerned were all "sold", but the sales status of the houses indicated on the Sales Price List of Newly Built Commercial Houses placed in the hall was all "unsold". After verification, 557 houses were sold, only 361 of which were sold at that time. The release of false information about "shortage of houses" easily led to the buyer making blind wrong judgments and thus damaging the legitimate rights and interests of the buyer, which is a false publicity act.

The party concerned violated the provisions of Paragraph 1 of Article 8 of the Anti Unfair Competition Law, and imposed an administrative penalty of 450000 yuan according to Paragraph 1 of Article 20 of the Anti Unfair Competition Law.

(2) False publicity case of a Hainan Agricultural Means of Production Service Co., Ltd

In April 2022, the law enforcement personnel found that the outer package of potassium fulvic acid fertilizer sold by the party concerned was marked with such publicity terms as "can promote the development and growth of roots and improve the disease resistance of crops, have special disease resistant bodies, and can play the role of crop agents". The role of fertilizer was originally only to promote plant growth. The party concerned regarded fertilizer as a pesticide to emphasize the therapeutic role as a false and misleading commercial publicity, which belongs to unfair competition.

The party concerned violated the provisions of Paragraph 1 of Article 8 of the Anti Unfair Competition Law, and imposed an administrative penalty of 20000 yuan according to Paragraph 1 of Article 20 of the Anti Unfair Competition Law.

(3) False publicity case of Binjiang Coast Store of a real estate brokerage company in Haikou

On May 12, 2022, the law enforcement personnel investigated the party according to the reporting clues, and found that the staff of the party falsely claimed that the house with 42.3 square meters of real estate certificate was 55 square meters in the process of selling second-hand houses to customers, which led to the customer paying the intention money under the condition of misunderstanding, which was a false publicity act.

The party concerned violated the provisions of the first paragraph of Article 10 of the Regulations of Hainan Special Economic Zone on Anti unfair Competition, and imposed an administrative penalty of 5000 yuan on the party concerned in accordance with the first paragraph of Article 35 of the Regulations of Hainan Special Economic Zone on Anti unfair Competition.

(4) A food supermarket in Qionghai sold counterfeit Red Bull beverages

In April 2022, the law enforcement officers found that the party sold a "Roke bull vitamin sports drink", and the product name was "Red Bull" on the product label, which was similar to the "Red Bull" trademark of Tiansi Pharmaceutical Health Care Co., Ltd. and the brand product with the Chinese name of "Red Bull" in many aspects in appearance and logo, which was enough to lead people to mistakenly believe that there was a specific connection between the two drinks, causing confusion among the public, which was a confusion.

The behavior of the party violated the provisions of Article 6 (4) of the Anti Unfair Competition Law. According to the first paragraph of Article 18 of the Anti Unfair Competition Law, the party was imposed an administrative penalty of confiscating 1500 cans of "Rocke bull vitamin sports drinks", confiscating 4539.24 yuan of illegal income, and imposing a fine of 15000 yuan.

(5) Commercial confusion case of a pharmaceutical company in Hainan

On June 7, 2022, according to the reporting clues, the law enforcement officers found that the parties involved in the sale of some piroxicam sodium eye drops not produced by the right owner of the registered trademark " Baineiting " marked as the trademark " Baineiting "  in the stores registered on the " Yaojingcai " platform, which was an act of confusion caused by the unauthorized use of the same trademark as the trade name of others with certain influence.

The party's behavior violates the provisions of Article 6 (1) of the Anti unfair Competition Law, and according to the provisions of Article 18 (1) of the Anti unfair Competition Law, the party is ordered to stop the illegal behavior and fined 20000 yuan.

(6) Commercial confusion case of a beer business department in Sanya

On November 8, 2021, the law enforcement officers found that the plaque hanging on the business premises of the parties was named "Qingdao Fresh Beer Direct Shop", and the decoration of the shelves in the shop contained such words as "Qingdao Fresh Beer" and "TSINGTAO Qingdao Beer". After verification, in order to attract customers, the party concerned used the name of "Qingdao Fresh Beer Direct Shop" to conduct business activities without the permission of Tsingtao Beer Co., Ltd. and misled consumers, which is a confusing act.

The party concerned violates the provisions of Article 6 (1) of the Anti Unfair Competition Law. According to the provisions of Article 18 (1) of the Anti Unfair Competition Law, the party concerned shall be ordered to stop the illegal act and fined 3000 yuan.

(7) A health care shop in Danzhou issued false advertisements

In January 2022, the law enforcement officers found that in the process of selling the probiotic camel milk formula milk powder product marked "Beiyinjian", the party had made a publicity advertisement about the sale of camel milk, claiming that camel milk has the functions of reducing blood sugar, protecting gastrointestinal health, promoting metabolism, skin care and beauty. In fact, the camel milk formula milk powder sold by the party belongs to food and does not have the function of medicine, It is a false advertising act that it is unable to provide evidentiary materials to prove the authenticity of its advertising content.

The party concerned violates the provisions of Item (2), Paragraph 2, Article 28 of the Advertising Law of the People's Republic of China, and is ordered to stop the illegal act and fined 4800 yuan according to Paragraph 1, Article 55 of the Advertising Law of the People's Republic of China.

(8) A food store in Sanya Tianya District issued false advertisements

On March 23, 2022, the law enforcement personnel found through supervision and inspection that the party concerned released two advertisements at the end of January 2022, the advertisements were "sea cucumber contains protein... does not contain cholesterol" and "sea cucumber has high nutritional value... improves male secretion ability, improves female metabolism... greatly enhances disease resistance", and the two advertisements were titled "Dalian Sea Cucumber Island Around Sea Cucumber Quality Experience Hall", It is a false advertising act that it is unable to provide evidentiary materials to prove the authenticity of its advertising content.

The party concerned violates the provisions of Paragraph 1 of Article 4 of the Advertising Law of the People's Republic of China, and is ordered to correct his illegal act and fined 4000 yuan according to Paragraph 1 of Article 55 of the Advertising Law of the People's Republic of China.

(9) A tobacco and alcohol firm in Qiongshan, Haikou infringed on trademark rights

On January 6, 2022, law enforcement officers received a report from the trademark owner that the parties concerned sold counterfeit Baijiu of "Wuliangye", "Guizhou Moutai", "Jiannanchun", "Guojiao 1573", "mengzhilan", "haizhilan" and "tianzhilan". It is found that the above Baijiu sold by the parties concerned are counterfeit products, which infringes upon the legitimate rights and interests of the trademark owner.

The party concerned has violated the provisions of Item (3) of Article 57 of the Trademark Law of the People's Republic of China. According to Item 2 of Article 60 of the Trademark Law of the People's Republic of China, the party concerned shall be confiscated of trademark infringing products and fined 50000 yuan.

(10) A case of a bearing company in Hainan infringing on the trademark right

On June 16, 2022, according to the clues of the report, an investigation was carried out on the clues of the parties involved in the sale of bearing products suspected of counterfeiting the registered trademarks of "NSK" and "FAG". It was found that the "NSK" trademark was a registered trademark of Seiko Co., Ltd., and "FAG" was a registered trademark of Schaeffler Technology Co., Ltd. The bearings of these two brands had certain popularity in the industry and good reputation in the market. Due to negligence in management, the parties involved were involved in some counterfeit bearings in the purchase, including 20 counterfeit "NSK" bearings and 33 counterfeit "FAG" bearings, which belong to trademark infringement.

The party concerned has violated the provisions of Item (3) of Article 57 of the Trademark Law of the People's Republic of China. According to Item 2 of Article 60 of the Trademark Law of the People's Republic of China, the party concerned shall be confiscated of trademark infringing products and fined 50000 yuan.

2. Two pharmaceutical companies in Anhui were punished for failing to meet the requirements of drug GMP

On September 13, 2022, Anhui Provincial Drug Administration made the decision of administrative penalty (WYJYDD [2022] No. 2-208): after receiving the provincial bureau's Letter of Assistance in Investigation (WYJXH [2022] No. 50), Anhui Kangle Traditional Chinese Medicine Slices Co., Ltd. issued a sales invoice for traditional Chinese medicine slices to Fuzhou Jiulong Urological Hospital Co., Ltd., and the two enterprises provided different sales varieties. Violated the relevant provisions of Article 122 of the Drug Administration Law of the People's Republic of China (revised in 2019), and divided by a fine of 160000 yuan according to the provisions of Article 122 of the Drug Administration Law of the People's Republic of China (revised in 2019).

On September 14, 2022, Anhui Provincial Drug Administration made the decision of administrative penalty (WYJYDD [2022] No. 2-314): after receiving the Notice of Anhui Provincial Drug Administration on the Legal Investigation and Handling of Anhui Jiahe and Chinese Medicine Technology Co., Ltd. and Other Two Companies (Y.J.B.Z.H.H. [2022] No. 220), the provincial bureau recently carried out drug GMP causal (in-flight) inspection on Anhui Jiahe and Chinese Medicine Technology Co., Ltd. and other two companies, Anhui Jiahe Traditional Chinese Medicine Science and Technology Co., Ltd. was found to have 1 serious defect and 4 general defects, which were comprehensively judged as not meeting the requirements of drug GMP. In violation of the relevant provisions of the first paragraph of Article 43 of the Drug Administration Law of the People's Republic of China (revised in 2019), Anhui Jiahe Traditional Chinese Medicine Technology Co., Ltd. was fined 220000 yuan in accordance with the provisions of Article 126 of the Drug Administration Law of the People's Republic of China (revised in 2019).

3. Wuxi Hua'ao Pharmaceutical Co., Ltd.'s case of producing and selling inferior drugs

On September 23, 2022, Jiangsu Provincial Drug Administration made an administrative penalty decision against Wuxi Huaao Pharmaceutical Co., Ltd., which violated the first paragraph of Article 98 of the Drug Administration Law of the People's Republic of China by producing and selling counterfeit drugs Provisions of. In accordance with Item 1 of Paragraph 1 of Article 32 of the Administrative Punishment Law of the People's Republic of China and Article 116 of the Drug Administration Law of the People's Republic of China, the following penalties were imposed: 1) 2091 boxes of Shidishui, a total of 41820 pieces (batch number: 210509), were confiscated; 2) Confiscate the illegal income of 11636.00 yuan (eleven thousand six hundred and thirty-six yuan); 3) RMB 160000.00 (one hundred and sixty thousand yuan) will be fined.

4. Panjin Taixing Materials Comprehensive Co., Ltd. made medical oxygen inspection record

On September 23, 2022, Liaoning Provincial Drug Administration issued the announcement of administrative penalty results (the 29th issue of 2022), and made the decision on administrative penalty (Liao Yao Jian (Ji San) Penalty [2022] No. 2. Because Panjin Taixing Materials Comprehensive Co., Ltd. compiled medical oxygen inspection records, it divided them into: 1) two bottles of medical oxygen with illegal production batch number 20220511 were confiscated according to the provisions of Item 6, Paragraph 1, Article 124 of the Drug Administration Law of the People's Republic of China, Confiscate the illegal income of 2380 yuan; 2) Order to suspend production and business for rectification for one month; 3) RMB 500000 will be fined.

三、 Professional Articles

1. Research on Tax related Crimes of Entrepreneurs in the Yangtze River Delta - Empirical Analysis Based on Judicial Cases (Original by Bai Lituan)

(Click to view the article details)

In the production and processing of agricultural and sideline products, the purchase and utilization of waste materials, the purchase and sale of bulk commodities (such as coal, steel, electrolytic copper, gold), construction projects, medicine and other industries and fields, due to some special reasons, there are enterprises that can not obtain compliance notes for entry, offset costs or settlement payments, even though they have real business, so there is the phenomenon of purchasing invoices by illegal means.

There are 12 tax related crimes in China's Criminal Law, which are divided into tax evasion crimes and invoice related crimes. Through judicial document retrieval, among the 12 charges, nearly 90% of the tax related cases are concentrated in the crime of falsely issuing special VAT invoices and the crime of tax evasion. The author used the "Alpha" judicial case database to query: from January 2011 to August 2022, there were 1527 tax related criminal cases of entrepreneurs in the Yangtze River Delta region (Zhejiang, Jiangsu, Anhui, and Shanghai). The Yangtze River Delta is one of the most developed regions in China, which has a significant impact on China's economic development. This paper hopes to reflect the basic status quo of entrepreneurs' tax related crimes in the Yangtze River Delta, reveal the legal risks of entrepreneurs' tax related crimes, and put forward relevant risk prevention and control suggestions through the following analysis and research of more than 10 years of relevant cases, so as to provide reference for effective prevention of entrepreneurs' tax related crimes.