Source: Beijing News

Author: Li Zhao, Wang Ailin

This summer, for pharmaceutical companies, there are two days of ice and fire.

The marketing department's sales team pressed the "suspension key". A pharmaceutical representative of a cities in a provincial capital of northwestern China said that many pharmaceutical companies recalling medical representatives at night will not be allowed to go to the hospital. The academic conference is densely canceled or postponed. Many peers are directly holiday.

On the other hand, the "standards of the standards" within the pharmaceutical company will be held frequently. The company conducts compliance training and builds a compliance system. A lawyer engaged in pharmaceutical compliance told the Beijing News reporter that since the anti -corruption operation, every dayI received a lot of telephone consultation compliance training in pharmaceutical companies.

On August 15th, the National Health and Health Commission issued a question and answer related to the centralized rectification work of corruption in the national pharmaceutical field, which pointed out that the National Health Commission and the nine departments jointly launched a one -year centralized rectification work in the national pharmaceutical field.Focusing on problems, focusing on the "key minority" and key positions in the pharmaceutical industry, resolutely rectifying illegal violations of laws and disciplines and violations of laws, building a positive industry atmosphere, and providing guarantee for the high -quality development of pharmaceutical and health undertakings.

"Compliance" has once again become the industry keywords of pharmaceutical companies. Where is the boundaries of compliance?How to from "formal compliance" to "substantial compliance"?The industry is "crossing the river with stones."

Press "Passing Key"

"All our daily work was suspended and changed to participating in product knowledge training meetings, and was notified that they were not allowed to visit the hospital in the short term." Zhang Wei was a medical representative in a pharmaceutical company.For the first time, she experienced "such a huge medical anti -corruption."

The work group within the company where Zhang Wei is located, and the communication groups between peers are almost all dissolved, and the remaining few groups that have not been dissolved.Work? "

Chen Li, who worked in the marketing department of a pharmaceutical company in the Yangtze River Delta, also felt the strength of the anti -corruption storm.Chen Li's work content is responsible for academic conference.The academic conference, which failed to hold it because of the impact of the epidemic, originally ushered in the explosion period this year -in the first half of the year, the company can organize more than a dozen academic conferences in the two days when the company's busiest is the busiest.Chen Li said, but from July 31st, all academic conferences were stopped or extended. "I don't know when to recover."

Chen Li's company is a state -owned enterprise. His marketing department is currently in the stage of rectification and self -reform. It is discussing what ways to adopt in orderPut on the muzzle ".

"Compliance" has become the most commonly mentioned words within the pharmaceutical company company.Li Cenyan, a manner for pharmaceuticals and director of Beijing to Jinjin Law Firm, explained that "compliance" means that the behavior of various enterprises "deep, all aspects of compliance with laws and regulations", including the laws and regulations issued by the state, and the state's laws and regulations, and the laws and regulations issued by the state, andRegulatory regulations, industry standards, as well as relevant international treaties and internal company rules and regulations.

For the grassroots practitioners of pharmaceutical companies, "compliance" is both familiar and unfamiliar.Zhang Wei said that since 2021, her company has implemented the "compulsory compliance" system (proposed a clear obligation to establish a compliance management system and imposed administrative penalties for companies that refused to fulfill compliance management obligations).Beginning last year, the company canceled the "business fee" of medical representatives, and the reimbursement also changed from "actual reporting and actual sales" to a fixed meal label or reducing the activity budget.But this time anti -corruption seems to be particularly different. "Recently, doctors have been emphasizing with us, do not call them, send WeChat, and do not mention sensitive vocabulary in communication, but I don’t know which expressions are now.Sensitive vocabulary. "

Li Cenyan said that compliance training is carried out in lectures.

Li Cenyan discovered that many practitioners' understanding and attention to compliance and attaching importance to compliance. The corporate manager's legal awareness was weak, and she was lucky. It was believed that some unsatisfactory behaviors were only in the category of minor violations, so as not to constitute a crime, such as a crime, such as a crime, such as a crime, such as a crime. For exampleThe form of illegal cash in the form of false invoices, "Many pharmaceutical companies have not even read the Drug Management Law of the People's Republic of China."

"Compliance"

lack of motivation

Compliance is not a new concept.

In 2018, in response to the business compliance of the enterprise, the State -owned Assets Supervision and Administration Commission of the State Council issued a document of the central enterprise compliance management guidance (trial) document. This year is considered to be the "first year of Chinese enterprise compliance".

But in the pharmaceutical industry, "compliance" is closely related to the industry trajectory.In 2006, the Central General Office and the General Office of the State Council jointly issued opinions on the special work on governing commercial bribery.In 2013, Glaxo Sik (GSK) China bribery incident broke out, and the incident directly set off a anti -corruption investigation against corporate compliance.

Li Chun became the chief compliance officer of a head foreign -funded pharmaceutical company this year. "The compliance officer is a position set by many first -class enterprises in the world.The formulation of compliance policies and systems within the company, related compliance training, and compliant monitoring of the behavior of employees within the enterprise. "

Li Chun said that this also includes fraud investigations on medical representatives.In academic conferences, this requires compliance officers to further investigate the root cause of the behavior, severity of the degree of fraud, etc. "

Li Chun mentioned that most domestic pharmaceutical companies do not have compliant consciousness and initiative, and do not set up the position of compliance officers separately.Because there is no "one -vote veto", the compliance officer can only play the role of "suggestion"."In the process", this overhead approach also made the compliance officer a role that was squeezed by the edge or exclusion within the company.

Li Chun told the Beijing News reporter that the chief compliance officer, as a core management position, cannot directly create benefits for the enterprise. Whether its establishment or not depends on the company's own understanding of compliance and whether it is accepted by acceptanceStrict willingness to regulate.

"For enterprises, the cost of compliance is roughly divided into two aspects. One is that related professionals need to pay a higher salary, and the other is that in a fierce business competition environment, some companies will implement compliance and promote businessAs a relationship of opposite, he is lucky to think that if the business model is compliant, the business will become less. "Li Chun said.

To some extent, this is also the main reason why domestic pharmaceutical companies have insufficient motivation for "compliance".Although "compliance" is no longer a new concept in domestic pharmaceutical companies, compared with foreign companies, domestic enterprises rarely set up compliance positions. "Due to human and cost considerations, some companies will also choose related compliance compliance.Function mergers are among the financial departments of the enterprise or the Legal Department. "

"More hidden"

"Focus on the key links of the production, supply, sales, use, and reimbursement of the production, supply, sales, use, and reimbursement in the medical field." This requirement is repeatedly mentioned in the centralized rectification work video conference in the national medical field and other 10 departments.

Li Cenyan told the Beijing News reporter that the pharmaceutical industry includes production enterprises, circulation enterprises, service enterprises, medical institutions, etc. The problems of pharmaceutical companies should be discussed and resolved in detail.At present, more than a thousand pharmaceutical companies in China are engaged in drug production. The production compliance of these companies has done a better production compliance. "The difficulty and problems of compliance often appear in the field of purchase and sales," that is, the supply and sales of drugs.

"In the case of original compliance, the medical representative needs to pass the professional information related to medicines to the doctor to help doctors evaluate and screen for the relevant characteristics and effects of the drugs in a comprehensive, in -depth, and detailed understanding of the drugs."Li Cenyan said, but in reality, if he wants a medicine to be selected by a doctor, some medicine representatives are in order to use the" plug red envelope "to exchange for more medicine orders for" taking shortcuts "and" copying the road "to achievePromotion.

Compared with the transfer remittance that is easily reported by "straightforward", Li Chun said that there are still many bribery means to use hidden, non -cash, non -property interest outputs, such as using personal interpersonal relationships, impact impactsPower or humanity, send experts to overseas travel, provide pick -up services, and provide unreasonable education, employment opportunities, etc. for their children.

Li Chun introduced that these forms are not easy to leave records and are difficult to trace responsibility. "Singapore's current legal system is difficult to regulate such non -financial business bribery. In addition, some bribery behaviors will be used to use the hospital in the name of the hospital to fight disaster relief or other normal normal.The shell of labor activities has also increased the difficulty of supervision and inspection of compliance officers. "

Previously, a special audit report on the production and distribution of drugs and high -value medical consumables (drafts for comments) in the industry was circulated in the industry. According to the economic observation report on August 9, the staff of a hospital in the report confirmed confirmedReport authenticity.

Many corruption mentioned in this report is very secretive.For example, some foreign pharmaceutical companies provide exclusive service arrangements for domestic authoritative medical experts. Ke Hui Medical Equipment International Trade (Shanghai) Co., Ltd. has long sponsored academic exchanges organized by the Association of Medical and Medical Associations at all levels, and requires domestic dealers to sell annual sales.2%pay for the participating doctors and experts to pay accommodation, pick -up, air tickets and other fees.

According to national regulations, medical staff need to continue medical education credits and not less than 25 credits each year. Participating in academic exchange activities can obtain credits but need to pay the registration fee.In 2022, Bayer Pharmaceutical Health Care Co., Ltd. and other pharmaceutical companies were 4,728 medical staff participating in the provincial medical associations of 40 academic conferences paid 1.3785 million yuan (RMB, S $ 250,000).

Inside many pharmaceutical companies, there will be KA (key customers) departments to establish a so -called "strategic cooperative relationship" with the hospital. This type of "voluntary charity" is also uncommon.Medical representative told the Beijing News reporter that last year's epidemic, her company "donated" more than 10,000 bottles of ibuprofen to the hospital, and a strategic cooperative hospital was absent from ambulance, and the company "donated" a ambulance.

"Gray Zone"

Medical representatives, as a key part of the compliance chain, are often trapped in the "gray zone".

Although in Zhang Wei’s statement, the company she works attaches great importance to "compliance", but she also admits that in actual work, she will inevitably face the "gray area". These "gray areas" are alsoThe company acquiesce.

Zhang Wei said that in the past, when paying for lectures with experts, the cost category and company name will be clearly marked, but some experts are "avoiding this method" and expressed their unwillingness to leave any written form of receipt certificates.Only accept cash and ask them to "cash out the money through other channels."Zhang Wei told the Beijing News reporter that the lecture fee was formulated uniformly by the company. From the perspective of the company, this formal form is unsatisfactory."But in order to have a good relationship with the experts, you can only try to meet the requirements of the other party."

Although this gray zone also existed by the company's acquiescence, when the storm came, Zhang Wei felt that he and many colleagues were abandoned.

Beginning in April and May of this year, Zhang Wei's company urgently moved out of the contract subject of many medical representatives from the head office and changed to a subordinate subsidiary or sales company.She said that as the government departments were issued one after another, in August 3, "the company asked us to sign a commitment, indicating that if individuals were associated, all behaviors were personal behaviors, and individuals assumed all responsibilities, which has nothing to do with the company."

On August 12, Zhang Wei received the latest notice during the meeting. All the positions of the company's medical representatives were locked. In the future, they will only lay off layoffs and no longer recruit people.Recently, she and her colleagues conducted internal training and study, and then conducted a second -quarter performance assessment.If it does not meet the standard, "it is likely that the entire department will be gone."

For a series of behaviors of pharmaceutical companies, Li Cenyan said that the purpose of pharmaceutical companies is to cut risk cutting from the legal subject. It is hoped that the establishment"Local response".From the judicial perspective, a simple paper commitment book does not completely let the enterprise clarify the responsibility.The judicial organs will also pay attention to and consider the process of the entire commercial bribery.

Li Cenyan said that this type of design through signing agreement and changing contracts to the design of the internal control system that is a medical representative is not a real compliance management construction, but this is also "the current anti -corruption storm in the current anti -corruption stormIn the following, the entire medical industry needs to think about future system design and compliance management. "

On July 25, the Fourth Session of the Fourteenth National People's Congress of the 14th National People's Congress first reviewed the amendments to the Criminal Law of the People's Republic of China (12) (draft), of which the legal punishment was adjusted, and it was matched with the legal crime of bribery.Realize "bribery and bribery and punishment."Li Cenyan introduced to reporters that the basis for judging the crime of bribes and personal bribery in the unit needs to consider the judgment of individuals and units belong to the cooperative relationship or labor relationship, whether the unit has direct or indirect benefits.

In the bribery of the pharmaceutical industry, medical representatives and pharmaceutical companies always want to "shake the pot" with each other.Li Cenyan pointed out that direct benefit means that personal bribery behavior directly brings benefits to the unit. "But many times the company will argue for themselves, and the business is outsourced out of the outsourcing, which has nothing to do with itself." This requires whether the bribery behavior is requiredThere are other transaction opportunities to indirectly bring other transaction opportunities, or increase the relevant transaction volume. "In summary, most of the bribes of individuals and units need to be responsible simultaneously."

Need healthier compliance culture to do soil

In the real process, the transformation of formal compliance to substantial compliance is still difficult.Taking the academic conference in this round of anti -corruption storm as an example, its specific standard line is not very clear to many respondents. For example, how should the amount of "lecture fee" be given?

This also points to another realistic dilemma of compliance: in the industry respondents mentioned that the lack of implementation details in the industry's existing consensus pharmaceutical compliance, and the rules formulated within the enterprise have certain limitations.Even the compliance standards of domestic and foreign capital are different. According to media reports, the compliance specifications used by Chinese pharmaceutical companies are more based on the regulations on the pharmaceutical industry of the China Chemical and Pharmaceutical Industry Association (CPIA).It is the RDPAC Industry Conduct (2022 revised edition) released by the China Foreign Investment Enterprise Association's Drug Development and Development Industry Committee (RDPAC).

However, in Li Cenyan's view, it may be difficult to introduce more detailed implementation standards in the future. At present, the existing laws and regulations have made a specification on many issues, but the company still has not completed it.? Enterprises should have the right to decide, otherwise it is difficult for enterprises to survive. "

"Compliance is essentially a management art." Li Cenyan said that the laws and regulations issued by the state only establish a basic and overall framework. The specific implementation details and regulations need to be according to the different situations of the enterprise.For formulation, "bribery with legal coats" cannot be solved completely on the compliance management system. More importantly, it is necessary to change the ideological transformation- "Don't try to do things through illegal channels."

In a round of corporate training, Li Cenyan can obviously feel that industry insiders attach more importance to "compliance". She believes that most companies are still in the stage of "knowledge" in the "prophets".Only after ideological consciousness can only explore the skillsAt this stage of compliance construction, a large number of compliance talents are required at this stage.

"The current domestic compliance talents are very scarce", but Li Cenyan also pointed out that compliance officials use professional knowledge to promote the establishment of the compliance system in the enterprise, and truly implement the participation of everyone in the enterprise."Everyone should be the compliance officer within their position. The chairman of the enterprise, as the first responsible person in corporate compliance, business supervisor is the first responsible person of departmental compliance. Everyone is his own post.The first responsible person of compliance. "

This year's anti -corruption operation, practitioners in pharmaceutical companies have been affected to varying degrees, and everyone is also facing choices.

With the continuous deepening of medical reform, the medical representatives who used to walk with "gold" and "human feelings" continued to reduce reduction. Zhang Wei witnessed the coming and out of this industry. Some people have been engaged in medical representatives for more than 15 years.Because the working status of high pressure cannot be endured within half a year of admission.In the northwestern city where Zhang Wei lives, this is a relatively free work time. She is willing to continue to do it, but she does not know how long this method will last in the future.

Whether Zhang Wei or Chen Li, they are "waiting", waiting for more specific, practical, and operable compliance rules to be introduced. This seems destined to be a long process. Some people choose to wait and see, and some people choose to leave. Some people choose to leave. Some people choose to leave.Some people still stay in place and do not know where to go.