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 Administrative Measures for Network Security of Medical and Health Institutions

02 Measures for the Supervision and Administration of Online Drug Sales

03 Announcement of the State Food and Drug Administration on the Filing of Class I Medical Devices

04 Notice of the State Food and Drug Administration on the Issuance of the Requirements for the Filing and Examination of Medical Device Product Registration Projects and Other Documents

05 notice of the device review center of the State Food and Drug Administration on Issuing the key points for technical review of novel coronavirus nucleic acid sampling equipment in the oropharynx (Trial)

06 Notice on Implementing the Administrative Measures for Information Disclosure of Medical and Health Institutions

二、 Latest case

01 Tianxin Pharmaceutical and other three enterprises were investigated and punished for falsely increasing the price of bulk drugs and falsely raising the price of drugs to obtain funds

02 Shanghai Donghai Pharmaceutical Co., Ltd. was fined 1.5 million yuan on suspicion of producing substandard drugs

03 The judgment of the second instance of the first drug patent linking lawsuit in China

三、 Professional Articles

01 Do EU and US regulations discriminate against China in cross-border data transmission? (Originated by You Yunting and Wang Ting)

一、 Latest regulations

1. Network Security Management Office of Medical and Health Institutions

Document No.: GWGF [2022] No. 29

Issued by: State Health Commission, State Administration of Traditional Chinese Medicine, State Bureau of Disease Control

Date of issue: August 8, 2022

In order to strengthen the network security management of medical and health institutions, further promote the development of "Internet + medical health", give full play to the role of health care big data as an important basic strategic resource of the country, strengthen the network security management of medical and health institutions, and prevent network security incidents, The Measures are formulated in accordance with the Basic Medical Health and Health Promotion Law, Network Security Law, Password Law, Data Security Law, Personal Information Protection Law, Key Information Infrastructure Security Protection Regulations, Network Security Review Measures, network security classification protection system and other relevant laws, regulations and standards.

The National Health Commission, the State Administration of Traditional Chinese Medicine and the National Bureau of Disease Control and Prevention are responsible for overall planning, guidance, evaluation and supervision of the network security work of medical and health institutions. Local health administrative departments at or above the county level (including traditional Chinese medicine and disease control departments, the same below) are responsible for the guidance and supervision of network security of medical and health institutions within their respective administrative areas.

Medical and health institutions shall be responsible for their own network security management, and all medical and health institutions shall agree in writing with information construction participants and relevant medical equipment production and operation enterprises on the network security obligations and liability for breach of contract of each party.

For new networks, the network security protection level shall be determined at the planning and declaration stage. Each medical and health institution shall comprehensively sort out the basic situation of various networks of the unit, especially the application of new technologies such as cloud computing, the Internet of Things, blockchain, 5G, big data, etc., and scientifically determine the network security protection level according to the functions, service scope, service objects, data processing, etc. of the network and relevant standards, and report to the superior competent department for approval.

Within 10 working days after the determination of the network security protection level, the network operator above the second level shall file with the public security organ, and report the filing situation to the superior health administrative department. If the network cancels or changes the security protection level, the network operator shall cancel or change the security protection level to the original public security organ within 10 working days, and simultaneously report to the superior health administrative department.

All medical and health institutions should strengthen the life-cycle security management of data collection, storage, transmission, processing, use, exchange and destruction. Data life-cycle activities should be carried out in China. If it is really necessary to provide data overseas due to business, they should conduct security assessment or review in accordance with relevant laws and regulations and relevant requirements. Data processing activities that affect or may affect national security should be submitted for national security review, Prevent data security incidents.

In case of network security incidents, all medical and health institutions shall report to the health administrative department and the public security organ in a timely manner.

(Source: National Health Commission  http://www.nhc.gov.cn/ ）

2、Measures for the Supervision and Administration of Online Drug Sales

Document No.: GWGF [2022] No. 29

Issued by: Order No. 58 of the State Administration of Market Supervision and Administration

Date of issue: August 3, 2022

The Measures are formulated in accordance with the Pharmaceutical Administration Law of the People's Republic of China (hereinafter referred to as the Pharmaceutical Administration Law) and other laws and administrative regulations in order to regulate the online drug sales and online drug trading platform service activities and ensure the safety of public drug use.

The SDA shall be in charge of the supervision and administration of drug online sales nationwide. The provincial drug supervision and administration department is responsible for the supervision and administration of online drug sales within its administrative region, the supervision and administration of third-party platforms for online drug trading, and the activities of drug marketing license holders and drug wholesale enterprises to sell drugs through the Internet. The departments responsible for drug supervision and administration at the level of cities divided into districts and counties (hereinafter referred to as drug supervision and administration departments) are responsible for the supervision and administration of online drug sales within their respective administrative areas, and for the supervision and administration of drug retail enterprises' activities of selling drugs through the Internet.

Those engaged in online drug sales shall be drug marketing license holders or drug handling enterprises with the ability to ensure the safety of online drug sales. Vaccines, blood products, narcotic drugs, psychotropic drugs, toxic drugs for medical use, radioactive drugs, pharmaceutical precursor chemicals and other drugs under special state control may not be sold on the Internet. Drug online retail enterprises shall not, in violation of regulations, give prescription drugs and Class A non prescription drugs to individuals by buying drugs as gifts or buying commodities as gifts.

Where prescription drugs are sold to individuals through the Internet, it shall be ensured that the sources of prescriptions are authentic and reliable, and a real name system shall be implemented. Drug online retail enterprises shall not directly display information such as the package and label of prescription drugs on the home page and home page of prescription drug sales. Before passing the prescription review, it is not allowed to display the instructions and other information, or provide services related to the purchase of prescription drugs.

An online drug selling enterprise shall keep complete records of qualification documents and electronic transactions of the supplier. Drug online retail enterprises selling prescription drugs shall also keep records of prescriptions, online pharmaceutical services, etc. The retention period of relevant records shall not be less than 5 years, and not less than 1 year after the expiration of the drug.

The third-party platform shall be filed with the provincial drug regulatory department where the platform is located.

The third-party platform shall review the qualification and quality and safety assurance capability of the drug online sales enterprises applying for settlement, establish registration files for the drug online sales enterprises, and verify and update them at least every six months, so as to ensure that the drug online sales enterprises settling in meet the legal requirements.

The third-party platform shall keep drug display, transaction records, complaints and reports and other information. The storage period shall not be less than 5 years, and not less than 1 year after the expiration of the drug.

The Measures shall come into force as of December 1, 2022.

(Source: National Health Commission  http: //www.samr.gov.cn/）

3、Announcement of the State Food and Drug Administration on Matters Related to the Filing of Class I Medical Devices

Document No.: (No. 62 in 2022)

Issued by: State Drug Administration

Date of issue: August 10, 2022

For the filing of domestic Class I medical devices, the filing person shall submit the filing materials to the drug regulatory department of the city divided into districts. For the filing of imported Class I medical instruments, the filing person shall submit the filing materials to the SDA.

When determining the product management category, it shall be determined according to the product description, intended use and product name examples in the Category I Medical Device Product Catalog, in vitro diagnostic reagent classification subcategory and other provisions in combination with the actual situation of the product.

If it is determined to be Class I medical devices according to the Product Catalog of Class I Medical Devices, the Classification Sub Catalog of In Vitro Diagnostic Reagents (hereinafter referred to as the Catalog) and relevant classification results, the filer shall file with the corresponding filing department; If it exceeds the contents of the catalog, it shall apply for classification and definition according to relevant working procedures. If it is clearly defined as Class I medical devices, it shall be filed with the corresponding filing department.

When filing medical devices, the filing person shall submit the required filing materials, fill in the filing form, and obtain the filing number. The archivist shall ensure that the materials submitted are legal, authentic, accurate, complete and traceable.

In case of any change in the registered medical devices, the contents of the registration information form and the technical requirements of the registered products, the registrant shall file the change with the original filing department, and submit the description of the change and relevant documents.

(Source: State Drug Administration  https://www.nmpa.gov.cn/ )

4、Circular of the State Food and Drug Administration on the Issuance of the Requirements for the Filing and Examination of Medical Device Product Registration Projects and Other Documents

Document No.: (No. 40 in 2022)

Issued by: State Drug Administration

Date of issue: August 31, 2022

In order to further deepen the reform of the evaluation and approval system and encourage the innovation of medical devices, in accordance with the Administrative Measures for the Registration and Filing of Medical Devices (Order No. 47 of the State Administration of Market Supervision), the Administrative Measures for the Registration and Filing of In Vitro Diagnostic Reagents (Order No. 48 of the State Administration of Market Supervision) Announcement of the State Drug Administration on Publishing the Requirements for Medical Device Registration Application Materials and the Format of Approval Documents (No. 121 in 2021) The Notice of the State Drug Administration on Publishing the Requirements for the Registration and Application Materials of In Vitro Diagnostic Reagents and the Format of Approval Documents (No. 122 in 2021) and the Notice of the State Drug Administration on Implementing the Administrative Measures for the Registration and Filing of Medical Devices and the Administrative Measures for the Registration and Filing of In Vitro Diagnostic Reagents (No. 76 in 2021), The State Drug Administration has organized a comprehensive revision of the current "Requirements for Filing and Examination of Medical Device Product Registration Projects (Trial)" and other documents.

The Medical Device Technical Evaluation Center of the State Drug Administration shall review the application materials of corresponding applications in the acceptance process according to the revised filing review requirements, and judge the integrity, compliance and consistency of the application materials in the technical evaluation process. The filing review does not analyze the rationality and sufficiency of the product safety and effectiveness evaluation, and does not judge the product risk benefit ratio. The filing review is applicable to medical device registration, license change, clinical trial approval and other applications.

(Source: State Drug Administration https://www.nmpa.gov.cn/ )

5、Notice of the device review center of the State Food and Drug Administration on Issuing the key points for technical review of novel coronavirus nucleic acid sampling equipment in the oropharynx (Trial)

Document No.: (No. 33 in 2022)

Issued by: Medical Device Technical Evaluation Center of the State Drug Administration

Date of issue: August 26, 2022

The review points are applicable to the product registration of novel coronavirus nucleic acid sampling equipment in the oropharynx, and are intended to guide the registration applicant to carry out product design and development and prepare product registration application materials.

This kind of products mainly adopt robot, sensor and other technologies, and are used in public places, medical institutions and other places for novel coronavirus pneumonia nucleic acid sampling (including mixed sampling and single sampling) in the oropharynx of people through automatic sampling or remote-control sampling by sampling personnel.

This category of products is defined by the classification of medical devices, and is clearly managed according to the third category of medical devices. The classification code is 22-11-00 according to the current Classification Catalogue of Medical Devices; The sampling facilities (such as sampling booths and sampling rooms) or vehicles (such as sampling vehicles) where they are located are not managed as medical devices.

The registration applicant shall establish a quality management system in accordance with the requirements of the Medical Device Manufacturing Quality Management Specification and its independent software appendix, and include risk management. Carry out product design and development, production management, quality control, etc. according to the requirements of the quality management system. The quality management system can be improved by referring to YY/T 0316, YY/T 0287, YY/T 0664, YY/T 1833 series standards (if applicable) and other standards.

The registration applicant shall determine the basic requirements for product safety and effectiveness based on the intended use, use scenario, structural composition, technical characteristics and other factors of the product, in accordance with the Basic Principles for Safety and Performance of Medical Devices and the requirements of its compliance technical guidelines, and carry out product design and development in combination with relevant guiding principles and standards. The product benefit risk assessment shall be carried out with reference to the Guiding Principles for Technical Review of Medical Device Product Benefit Risk Assessment Registration to ensure that the product benefit outweighs the risk.

The registration applicant shall prepare the product registration application materials in accordance with the requirements of the Announcement on Publishing the Requirements for Medical Device Registration Application Materials and the Format of Approval Documents, in combination with the requirements of this review point and the relevant guiding principles. Judge the applicability of the specific contents of the review points and relevant guiding principles based on the product characteristics, and specify the reasons for the inapplicable contents.

(Source: China National Drug Administration (SDA)  https://www.cmde.org.cn/ )

6、Notice on the Implementation of the Administrative Measures for Information Disclosure of Medical and Health Institutions

Document No.: HWB [2022] No. 2

Issued by: Shanghai Municipal Health Commission Office

Date of issue: August 31, 2022

In order to standardize the information disclosure of medical and health institutions, improve the level of medical and health services, and facilitate citizens, legal persons and other social organizations to access the service information of medical and health institutions, the National Health Commission, the State Administration of Traditional Chinese Medicine, and the National Bureau of Disease Control jointly issued the Notice on Printing and Distributing the Administrative Measures for Information Disclosure of Medical and Health Institutions (GBF [2021] No. 43, hereinafter referred to as the Measures), Effective from February 1, 2022. At the same time, the General Office of the National Health Commission issued the Notice on Printing and Distributing the Basic Directory of Information Disclosure of Medical and Health Institutions (GBGZF [2022] No. 1, hereinafter referred to as the Basic Directory) in January 2022.

Medical and health institutions shall disclose the information produced and obtained in the process of providing social public services in accordance with relevant laws and regulations, the Measures and the Basic Catalog. The public subjects include:

(1) Hospitals, including general hospitals, traditional Chinese medicine hospitals, integrated Chinese and western medicine hospitals, specialized hospitals, rehabilitation hospitals, Internet hospitals, etc;

(2) Grassroots medical and health institutions, including community health service centers, community health service stations, village clinics, etc;

(3) Maternal and child health care institutions, including maternal and child health centers, maternal and child (infant) health care hospitals (institutes);

(4) Centers for Disease Control and Prevention;

(5) Health education institutions, including the municipal health promotion center and health education institutions in all districts;

(6) First aid center, including first aid center and first aid station;

(7) Blood station;

(8) Other public health institutions, including occupational disease prevention and treatment centers, dental (eye disease) prevention and treatment centers (institutes), mental health sub centers of the Centers for Disease Control and Prevention and other specialized disease prevention and treatment centers (institutes).

(Source: Shanghai Municipal Health Commission Office  https://wsjkw.sh.gov.c/ )

二、 Latest case

1、Three enterprises including Tianxin Pharmaceutical were investigated and punished for falsely increasing the price of APIs and illegally raising the price of drugs to obtain funds

On August 9, the State Medical Insurance Bureau officially released a circular on the situation of Guangzhou Baiyunshan Tianxin Pharmaceutical Co., Ltd., Guangzhou Baiyunshan Pharmaceutical Group Co., Ltd. Baiyunshan Pharmaceutical General Factory, and Guangzhou Baiyunshan Jingxiu Hall Pharmaceutical Co., Ltd. falsely increasing the price of APIs to obtain funds.

According to the investigation, from 2017 to May 2021, in order to avoid the "two vote system" policy and supervision, three drug manufacturers, including Tianxin Pharmaceutical, colluded with more than 50 downstream drug agents to cash out 87 kinds of drugs, including cefathiamidine for injection, by purchasing raw materials at inflated prices, and transferred funds to downstream drug agents. The amount involved is huge, and some of the funds are used to bribe medical personnel or specific related persons to carry out illegal drug promotion.

At present, Tianxin Pharmaceutical and other three enterprises have conducted price rectification on 87 kinds of drugs involved in the case, including cefathiamidine for injection, nationwide as required. The current prices used for bribery and other false high parts have been removed, with an average decrease of more than 50%, and some product specifications have been stopped from purchasing. Guangdong Province ordered 3 enterprises including Tianxin Pharmaceutical and other related enterprises to comprehensively rectify the marketing model and stop relevant illegal operations. In addition, the relevant departments are investigating and dealing with those suspected of violating disciplines, laws and crimes in accordance with the law.

2、Shanghai Donghai Pharmaceutical Co., Ltd. was fined 1.5 million yuan on suspicion of producing substandard drugs

On September 10, 2021, Shanghai Municipal Drug Administration sampled the nine vitamin cod liver oil produced by Shanghai Donghai Pharmaceutical Co., Ltd. On January 19, 2022, through the inspection of Shanghai Institute for Food and Drug Control, the content of vitamin A in this batch did not meet the requirements.

According to the first paragraph of Article 117 of the Drug Administration Law of the People's Republic of China "Where inferior drugs are produced or sold, the drugs illegally produced or sold and the illegal income shall be confiscated, and a fine of not less than ten times but not more than twenty times the value of the drugs illegally produced or sold shall be imposed. If the value of the drugs illegally produced or sold is less than 100000 yuan, it shall be calculated as 100000 yuan; if the value of the drugs illegally retailed is less than 10000 yuan, it shall be calculated as 10000 yuan; if the circumstances are serious, it shall be ordered to stop production or business for rectification or even revoke the drug approval certificate The document, the drug production license, the drug trade license, or the pharmaceutical preparation license of a medical institution shall be clearly stated. " The Shanghai Municipal Drug Administration has imposed the following penalties: confiscating the illegally produced products: 42 bottles of Jiuwei cod liver oil; Confiscation of illegal income: RMB seventy-six thousand six hundred forty-five point fourteen; Penalty: RMB one million five hundred thousand only.

3、The second instance judgment of the first drug patent linking lawsuit in China

On August 5, 2022, the Supreme People's Law publicly announced the case of the second instance of the dispute between the appellant Sino foreign Pharmaceutical Co., Ltd. and the respondent Wenzhou Haihe Pharmaceutical Co., Ltd. on whether to confirm that it falls within the scope of patent protection. The Supreme People's Court held that the appeal request of Sino foreign Pharmaceutical Co., Ltd. could not be established, and made (2022) Supreme People's Court Zhi Min Zhong No. 905 judgment to reject the appeal and uphold the original judgment.

This case is the first case of drug patent linkage litigation in China since the implementation of the new Patent Law.

Brief introduction of the case

The appellant, Sino Foreign Pharmaceutical Co., Ltd., is the patentee of No. 200580009877.6, entitled "ED-71 Preparation" (hereinafter referred to as the patent involved), and is also the marketing license holder of the related patented drug "Idicalcidol Soft Capsule". Chinese and foreign pharmaceutical companies found that the appellee Wenzhou Haihe Pharmaceutical Co., Ltd. (hereinafter referred to as Haihe Company) applied to the State Drug Administration for the registration of a generic drug marketing license application named "Idicalciferol Soft Capsule", and also made a Class 4.2 statement on the above generic drugs on the Chinese patent information registration platform for listed drugs, that is, its generic drugs did not fall within the scope of relevant patent protection.

Therefore, according to Article 76 of the new Patent Law, Sino foreign Pharmaceutical Co., Ltd. filed a lawsuit in the first instance to Beijing Intellectual Property Court to confirm whether it falls within the scope of patent protection, and requested to confirm that the generic drug "Idicalciferol Soft Capsule" applied for registration by Haihe Company falls within the scope of patent protection.

The Beijing Intellectual Property Court held that the generic drugs involved in the case did not fall within the scope of patent protection, and made (2021) J73 MCH No. 1438 judgment to reject the lawsuit request of Sino foreign Pharmaceutical Co., Ltd. Sino foreign Pharmaceutical Co., Ltd. appealed to the Supreme People's Court against the judgment of first instance.

After hearing, the Supreme People's Court held that: (1) although the Class 4.2 statement made by Haihe Company was improper, it did not adversely affect the entity and litigation rights of Sino foreign Pharmaceutical Co., Ltd., and the lawsuit request of Sino foreign Pharmaceutical Co., Ltd. for criticism of education itself was obviously untenable due to lack of legal basis; （2） The antioxidant in the generic drug technical scheme declared by Haihe Company to the State Drug Administration is not dl- α- Tocopherol, relevant appeal claims of Sino foreign Pharmaceutical Co., Ltd. are lack of basis; （3） Antioxidant excipients in the generic drug application involved and dl in the patent involved- α- Tocopherol does not constitute an equivalent technical feature, and the technical solution of the generic drug involved in the case does not fall within the scope of patent protection. The relevant appeal claim of Sino foreign Pharmaceutical Co., Ltd. is lack of basis, and the court does not support it.

三、 Professional Articles

1、Do EU and US regulations discriminate against China in cross-border data transmission? (Originated by You Yunting and Wang Ting)

(Click to view the article details)

At the beginning of the Internet, the cross-border flow of data was free, but since 2016, countries have promulgated laws to restrict cross-border data transmission to protect network security, data security, and personal information security. The law is political, so there is preferential treatment and harshness. Today, let's compare the cross-border data transmission regulations of the EU, the United States and China to see whether Europe and the United States have preferential treatment for each other? Have you raised standards unreasonably for China? And if Chinese enterprises are discriminated against, do we have any countermeasures?