New regulations restrict the behavior of medical representatives
Cut off the benefit chain of drug rebates
The pharmaceutical industry ushered in stricter supervision.
A few days ago, the "Administrative Measures for the Registration of Medical Representatives (Trial)" (hereinafter referred to as the "Measures") organized and formulated by the State Drug Administration was officially implemented.
The "Measures" clearly states that medical representatives shall not undertake the task of drug sales, collect payments and process purchase and sale bills and other sales activities; drug marketing license holders shall not encourage or imply that medical representatives engage in illegal activities.
What kind of group is the medical representative who has caused a lot of controversy in recent years?
The reporter saw in the new edition of "The Occupation Classification Code of the People's Republic of China" that as a formal profession, the work tasks of medical representatives mainly include four aspects: one is to formulate plans and plans for the promotion of medical products; the other is to deliver medical products to medical staff Relevant information; the third is to assist medical staff in the rational use of drugs; the fourth is to collect and feedback on the clinical use of drugs.
It can be seen that this profession originally had a strong sense of academic promotion.
However, in practice, some pharmaceutical companies directly link the sales performance of pharmaceutical representatives to income. Driven by profits, the nature of many pharmaceutical representatives’ work has been distorted into pharmaceutical sales, which has become a frequent issue of corruption in the medical field and the prohibition of the drug sales model. One of the endless reasons.
"In order to achieve the purpose of opening up drug sales channels and increasing the price of drugs, some so-called'medical representatives' influence their medication behavior by sending rebates to doctors, which has become a breeding ground for corruption, and to a certain extent led to falsely high drug prices. "Cen Jue, deputy secretary of the Party Committee and Secretary of the Disciplinary Committee of Shanghai Sixth People's Hospital, said.
A case information disclosed by the China Judgment Documents website shows that Hu Shuangfei, the former director of the Department of Anesthesiology, Zhejiang Provincial People’s Hospital, has repeatedly received benefits from a company’s medical representative Ye Mou, and accumulative kickbacks have been collected for only the “dizocine” injection. More than 1.25 million yuan.
Cen Jue said that although the rebate issue is hugely harmful, the responsibility should not be solely attributed to medical representatives: “The deviation of some pharmaceutical companies’ business concepts is the deeper reason.” According to statistics, from 2016 to 2019, there were 100% More than half of the compulsory drug companies have been found to have directly or indirectly given kickbacks. Among them, the most frequent companies involved more than 20 cases in three years, and the kickback amount in a single case exceeded 20 million yuan.
In fact, since the bribery case of the pharmaceutical giant GlaxoSmithKline was exposed, the call for "regulating the order of drug distribution and curbing corruption in the drug distribution field" has continued to rise.
In recent years, with the continuous deepening of the medical reform, a series of policy measures such as the "two-invoice system" for drug procurement, the national centralized procurement of drugs, medical prices and the credit evaluation of recruitment and procurement have been implemented successively, and the gray space for drug sales with gold has been greatly reduced. compression.
Many experts said that after the promulgation of the "Measures", under the rigid constraints of the system, unhealthy trends in the field of pharmaceutical purchases and sales are expected to be further curbed.
"The purpose of the "Measures" is to distinguish medical representatives who are truly engaged in academic promotion from those who are solely engaged in sales, give full play to the role of medical representatives in academic support, standardize the order of the industry, and promote a healthy and orderly pharmaceutical industry. Development." The relevant person in charge of the State Food and Drug Administration stated in an interview that in addition to clarifying the definition of medical representatives, the main tasks and the five forms of academic promotion, the "Measures" also clarified the requirements of drug marketing license holders. The main responsibility is to propose 5 prohibitions for the holders and 7 prohibitions for the medical representatives. The core is to strengthen the strict management of the drug marketing license holders on the medical representatives.
In Cen Jue’s view, the promulgation of the "Measures" will help pharmaceutical representatives to embark on a path of compliance and specialization. It can also encourage pharmaceutical companies to carry out business activities in accordance with regulations and laws, breaking the original gray interest chain: In other words, in the future, only with strong academic abilities can you achieve the original source of the profession. Whether you have professional drug knowledge, whether you can conduct academic exchanges with doctors under a more standardized premise, and give clinical professional advice, you will become a medical representative The key to gaining a foothold in the industry."
According to reports, after the registration system for medical representatives is officially launched, drug marketing authorization holders need to enter, change, confirm, and delete their medical representative information on the registration platform designated by the State Drug Administration as required, and medical institutions can check and verify on the registration platform Record information of medical representatives.
The online seminar on medical representative registration held by the Chinese Pharmaceutical Association on November 29 last year further clarified the scope of the record, pointing out that all those who need to carry out academic promotion activities belong to the broad "medical representative" category.
"From the perspective of hospitals, we welcome the registration system for medical representatives very much." Cen Jue said, "In the past, our practice was to issue'temporary access licenses' to medical representatives recognized by hospitals. Now we have a national authority for registration. Hospitals can more quickly and accurately identify the identities of regular medical representatives."
The relevant person in charge of the State Food and Drug Administration stated that only by continuously consolidating co-governance and building a joint management structure, can the system and regulations give full play to their effective use: “The drug marketing authorization holders must have true information about the medical representatives who file for the record. It is responsible for sex, and is first responsible for all violations of regulations, disciplines and laws that occur during the promotion of medical representatives; medical institutions must not allow undocumented personnel to carry out academic promotion and other related activities for medical staff or pharmaceutical personnel of this medical institution. We It also encourages industry associations and other social organizations to give full play to the role of industry supervision and self-discipline, and actively guide and urge member units to do a good job of filing medical representatives."
"If the holder of a drug marketing license or a medical representative grants property or other illegitimate benefits to the persons who use their drugs, they will be severely investigated and dealt with in accordance with the Drug Administration Law and other relevant laws and regulations." The person in charge emphasized.
The implementation of the new regulations is also inseparable from the guarantee of supervisory power.
The relevant person in charge of the Discipline Inspection and Supervision Group of the State Supervision Commission of the Central Commission for Discipline Inspection and the General Administration of Market Supervision stated that they will base their responsibilities and focus on the implementation of the "Measures", focus on procedures and supervise implementation, and make them an important content of the discipline inspection and supervision organization Mimin Livelihood Supervision Network Follow up and carry out supervision and inspection: "Strictly investigate and deal with problems that are found in the supervision and inspection of market supervision, drug supervision and other departments that do not perform their functions and responsibilities, and always maintain a high pressure situation." (Reporter Zuo Han嫡)