The Blue Book of Compliance for Chinese Pharmaceutical Companies and Medical Institutions (2019-2020) is released

　　Nearly 800 administrative penalties 90% are directed to private medical institutions

　　□ Our reporter Wen Yuanhao

　　On January 29, Simcere Pharmaceutical was fined 100 million yuan by the State Administration of Market Supervision for abusing its dominant market position. On the same day, Xu Xuzhong, the former director of the Department of Anesthesiology of the First Affiliated Hospital of Wenzhou Medical University, issued the final ruling on the bribery case, and Hengrui Pharmaceuticals and other companies offered bribes It was revealed...In recent years, violations of regulations such as monopoly, bribery, patent infringement, and false propaganda in the pharmaceutical and medical industry have continued to appear.

　　The China Corporate Legal Affairs Research Institute of the Rule of Law Daily, in cooperation with the School of Medical Humanities of Peking University, Beijing Tianshuang Law Firm, and A&C (Shanghai) Hospital Management Co., Ltd. recently released the ``Blue Book of Compliance for Chinese Pharmaceutical Companies and Medical Institutions (2019-2020)'' ( Hereinafter referred to as the Blue Book), it deeply analyzes the "pain points" of compliance in the pharmaceutical and medical industries, and gives specific compliance opinions.

　　It is understood that the Blue Book is divided into four parts. In addition to the compliance of pharmaceutical manufacturing companies and traditional pharmaceutical distribution companies, it also analyzes the compliance status of hot Internet pharmaceutical companies and private medical institutions.

　　Monopoly of APIs attracts attention

　　"Sale with gold" repeated bans

　　The compliance risks faced by pharmaceutical manufacturers and traditional pharmaceutical distribution companies include raw material drug price control and centralized drug procurement, academic promotion, drug clinical trials, drug patents, pharmaceutical exports, pharmaceutical enterprise trademarks, pharmaceutical enterprise marketing, and taxation.

Among them, the monopoly of APIs and academic promotion attract the most attention.

　　According to the analysis of the Blue Book, there are two main reasons for the monopoly of APIs: one is that the number of API manufacturers is relatively limited; the other is that the environmental law enforcement in recent years has caused many small and medium-sized API companies to shut down and switch, making the number of API manufacturing companies even larger. less.

In the preparation market, if the number of production enterprises is large, it is easy to form a fully competitive market environment.

If there are fewer than 5 actual production companies, it is often easier to form a monopoly.

　　In response to the frequent issue of monopoly in the field of APIs, the National Development and Reform Commission issued the "Guidelines for the Price Behavior of Shortage Drugs and API Operators" in November 2017, which listed the specific manifestations of various monopolistic behaviors in the field of shortages and APIs , To provide practical anti-monopoly compliance guidelines for API manufacturers and sales companies.

　　To this end, the Blue Book recommends that relevant companies conduct self-assessments in accordance with the guidelines and combine existing law enforcement cases to examine whether there is any content in the current business model that is suspected of touching the red line of the antitrust law, and make timely adjustments.

Especially when there are only a few API manufacturers in the market, manufacturers need to be extra cautious when engaging in the following actions: increase prices beyond a reasonable range; reach exclusive distribution or exclusive agency agreements with distributors; and compete The parties reached an arrangement on joint price increases, market segmentation or refusal to supply to third parties.

　　Academic promotion is the "old and difficult" problem in the medical and medical industry's compliance.

In recent years, companies or doctors have been fined repeatedly for non-compliant marketing such as case collection, academic conferences, and clinical trials.

　　"These fined companies often only achieve formal compliance, but fail to achieve de facto compliance." The Blue Book believes that the core of de facto compliance is not having a relationship with direct interest parties and sales.

Regardless of whether the specific implementation method is a targeted subsidy or only a small number of departments have travel, gifts and sponsorships, as long as it is linked to sales, it is not a factual compliance.

　　During the interview, Wan Xin, the chief author of the Blue Book and director of Tianshuang Law Firm, said that the use of rebates to stimulate doctors to write prescriptions, increase drug sales, and directly accept academic promotion sponsorships, sponsor department directors to go abroad, and support tourism consumption, etc., have all obviously happened. The relationship with sales.

It is not impossible for pharmaceutical companies to sponsor academic conferences. This is also one of the current main academic marketing methods, but it must be reasonable catering service fees, travel expenses, and accommodation fees. Sponsoring business class international travel and high-standard hotels is obviously beyond the standard.

　　"As the relevant state departments intensify their crackdowns on medical bribery, the traditional drug'sales with gold' model has come to an end, and compliance sales have become the only choice for pharmaceutical companies." The Blue Book believes that the so-called academic promotion of compliance is one It is necessary to have a complete record and a complete chain of evidence for promotion, including time, location, people, events, organizers, on-site photos and expense invoices, etc.; second, all businesses must occur in real terms and must not be given to doctors that do not match the market price High remuneration; thirdly, it is not compliant to transfer cash and conduct marketing activities in any way, which is essentially a way of money laundering.

　　The Blue Book pointed out that a large number of pharmaceutical companies are actually offering commercial bribery in the name of academic promotion. However, as the auditing of pharmaceutical commercial bribery becomes stricter, high-pressure policies continue to be implemented, and supervision continues to be forced, pharmaceutical companies will eventually be required to complete factual compliance.

　　E-commerce sales are favored

　　The bottom line of compliance cannot be ignored

　　Under the epidemic situation, digital marketing and live broadcast marketing are increasingly favored by the medical and medical industry.

Statistics show that my country's medical e-commerce has involved medical equipment, pharmaceutical machinery, analytical instruments, medical consumables and drugs.

From 2015 to 2018, the total sales of my country's pharmaceutical e-commerce direct reporting enterprises increased from 47.6 billion yuan to 97.8 billion yuan. In 2019, the total sales of pharmaceutical e-commerce reached 123.5 billion yuan.

　　In the Internet environment, medical advertisements need to pay special attention to three aspects: First, in the live webcast, advertisements for medical treatment, medicine, medical equipment, etc. that should be reviewed before release are not allowed.

The second is to pay attention to avoiding the corresponding risk of violation in the WeChat official account soft text.

For example, it is suspected of advertising endorsements to push patients’ personal medical records, and the use of the patient’s image for recommendation and certification is prohibited by the Advertising Law and the "Interim Measures for the Administration of Advertising Review"-especially notable that the patient's consent is required, otherwise It is easy to be held accountable for infringement.

The third is to not have advertising violations.

When publishing a pop-up medical advertisement, if the closing sign is not marked in a prominent position, or if it pops up again within a short time after closing, it cannot be guaranteed to close with one click, and it is an advertising violation.

　　The Blue Book recommends that we stick to the bottom line of advertising compliance and avoid using disease symptoms as an entry point to promote drugs.

　　For pharmaceutical e-commerce, the Blue Book believes that the compliance challenges they face mainly come from the subject qualifications, platform management, online prescription drugs, drug quality defect disputes, and Internet drug advertisements.

Among them, the responsibilities of third-party platforms, live webcasts, and online sales of prescription drugs require particular attention.

　　Wang Yue, chief author of the Blue Book and deputy dean of the School of Medical Humanities at Peking University, said that under the background of favorable policies such as Internet + medical health, it is the general trend to liberalize the online sales of prescription drugs, and it is only a matter of time.

The speed of time depends largely on the compliance level of the industry.

Linking to Internet hospitals is undoubtedly an important channel for pharmaceutical companies to obtain prescriptions.

Although the policy has provided a legal basis for online sales of prescription drugs, the specific implementation methods still need to be revised. Before the standards are completely clear, ensuring legal innovation is the current priority.

　　Repeated punishment in a short time

　　Private institutions are more common

　　In recent years, the medical and health industry has been highly sought after by the capital market.

In 2020, the number of Chinese medical and health companies' IPOs will reach 63, a record high, with a year-on-year increase of more than 65%.

However, the proportion of private medical institutions is not high.

　　In this regard, the Blue Book believes that the reasons for the failure of private medical institutions to go public are different, but compliance issues have been repeatedly mentioned.

The main problems focus on the authenticity of the profits of listed companies, including legal and tax issues; it is difficult to achieve legal compliance with drug supply rebates; related transaction issues, strict supervision over the transmission of the interests of major shareholders; marketing standards, etc.

In addition, some hospitals use the pre-sale model, which will never make a profit, and the medical insurance control fee also brings challenges to the listing of medical companies.

If private hospitals account for more than 50% of medical insurance, and in the case that social capital is applying for medical insurance, if this proportion is continuously increased, there will be great pressure to control fees.

　　Wanxin believes that in the previous feedback on the Kangning Hospital’s A-share IPO, the Securities Regulatory Commission paid attention to the full-time issues of the staff, asked about the professional title level, work resumes and working hours of the Kangning Hospital’s doctors, and asked whether There is a situation of "walking" or part-time.

It can be seen that the independence of personnel in private hospitals may be focused on.

　　In addition to listing risks, the compliance risks that private medical institutions usually face also involve establishment, practice, labor and personnel management, commercial contract management, medical damage liability handling, and compliance management related to the new crown pneumonia epidemic.

In the establishment phase, 99 institutions were punished from 2019 to 2020, of which 44 were due to personnel qualifications, 41 were due to incomplete medical institutions, and 14 were illegal propaganda.

　　Among the names of private institutions, the main problems include the name of the establishment unit or the name of the individual that is not included, the registration name of the subject qualification registration authority is inconsistent with the name of the medical institution approved by the health administrative department, and the trademark protection of the name of the medical institution.

For example, the name registered by the administrative department of industry and commerce is "Beijing New Times Yimeier Xingfu Medical Beauty Hospital Co., Ltd.", and the name registered with the Beijing Municipal Health and Family Planning Commission is "Beijing New Times Yimeier Xingfu Medical Aesthetic Hospital" .

　　The Blue Book's compliance analysis found that from 2019 to August 2020, Beijing and Shanghai made 785 cases of administrative punishment against 586 medical institutions.

In terms of the types of medical institutions, there are 255 comprehensive medical institutions, 77 traditional Chinese medicine medical institutions, 273 dental medical institutions, 165 medical beauty institutions, and 15 other types of medical institutions.

Among these penalties, there were 66 penalties against public medical institutions and 719 penalties against private medical institutions, accounting for 90%.

Repeated punishments within a short period of time are more common in private medical institutions.

　　Among them, the reasons for the penalties are mostly medical waste and sewage treatment, radiological diagnosis and treatment, and medical record management violations, and the highest penalties are violations of publicity, imperfect management systems, and medical record management violations.

　　Ding Jiejing, vice president of A&C (Shanghai) Hospital Management Co., Ltd., said that private hospitals and private doctor groups born out of the medical reform are both useful supplements to the public medical service system.

Private doctor groups not only need to have both clinical technology and services beyond the top three hospitals and the ability to raise the industry level of a certain technology to a new level, but also need to adhere to the bottom line of compliance to achieve sustainable development.