A New Era Of Medical Representative Record Keeping: Curbing The Return Of "Sales With Gold" To "Academic Value"

With the implementation of the filing policy, the value of medical representatives will be reshaped and adjusted.

On December 1, the administrative measures for the record keeping of medical representatives (Trial Implementation) issued by the State Food and Drug Administration (SFDA) (hereinafter referred to as the administrative measures) will be formally implemented, which also means that the medical representative filing system, which has been brewing since 2017, will be formally implemented.

"In the process of health care reform, commercial bribery and sales with money related to third-party drug promotion enterprises and pharmaceutical representatives have been prohibited repeatedly. The introduction of the registration system of pharmaceutical representatives is intended by the regulatory authorities to uniformly and continuously publicize, supervise and manage the drug marketing license holders (MAH) and their authorized pharmaceutical representatives, and standardize their drug promotion activities." On December 1, Lu fan, an executive in the Sales Department of a pharmaceutical listed company, said in an interview with the reporter of the 21st century economic report.

Curb "gold sales"

In the pharmaceutical industry, it is common to provide sales rebate to doctors by making false invoices.

On November 29, according to a report from Guangzhou police, Zhuhai police, together with the third Inspection Bureau of Guangzhou Taxation Bureau, investigated and dealt with a very serious case of falsely issuing special VAT invoices for the pharmaceutical industry, destroyed a criminal industrial chain composed of drug manufacturers, agents, pharmaceutical representatives and shop assistants of individual hospital pharmacies, and arrested 41 criminal suspects. Among them, the total amount of rebate for payment of money to the designated account of relevant medical representatives under the subject of "payment for goods" is as high as 360 million yuan.

Usually, it's a conspiracy between a medical representative and a drug agent. Pharmaceutical representatives purchase drugs from pharmaceutical enterprises in the name of agents, and then falsely issue VAT invoices through forged transactions of empty shell companies under their control, so as to raise the price of drugs, and then sell them to hospitals and pharmacies at high prices. The pharmaceutical representatives occupy the leading position in the whole industry chain, and can share 85% - 90% of the profits. The price of drugs is nearly tripled in this circulation process.

For such a phenomenon, in addition to heavy blows, policy supervision has also continued to increase. According to Article 4.2 of "discretionary benchmark for medical price and bidding credit rating (2020 Edition)" issued by the medical price and bidding procurement guidance center of the State Medical Insurance Bureau on November 18, 2020, in the cases of false value-added tax invoice investigated and dealt with by the local tax department, it belongs to the party that obtains the false VAT invoice, and the total amount of price and tax involved in the case is more than 10 million yuan, and the credit rating is evaluated It is defined as "particularly serious", which also means that pharmaceutical enterprises will be suspended from the network, bidding or distribution qualification of all drugs and medical consumables by local medical insurance.

In recent years, with the continuous promotion of the two ticket system and the purchase with quantity, the circulation space of medicine has been squeezed, and this kind of over ticket behavior has been further eliminated. With the formal implementation of the management measures, the phenomenon of "sales with money" of medical representatives will be curbed from the source.

Return to academic value

According to the definition of "occupational classification canon", medical representatives are professionals engaged in drug information transmission, communication and feedback. "But in the process of practice in China, many pharmaceutical companies confuse pharmaceutical representatives with sales staff, and their responsibilities are unclear." LV fan told the 21st century economic reporter that after the introduction of the policy, the positions and functions of medical representatives have been further clarified and standardized, which is ideal for the industry.

According to the provisions of the administrative measures, the holder of the drug marketing license is the responsible subject of the medical representative's filing. After signing the contract with the medical representative and clearly authorizing the promotion of the drug category, the holder shall complete the information filing and publicity according to the requirements, and standardize the behavior of the pharmaceutical representative. And the main work of medical representatives also makes clear that the return of drug promotion and feedback of clinical use information, can not carry out academic promotion activities without filing, can not undertake the task of drug sales, implement collection and processing of purchase and sales bills and other sales behavior. On the other hand, the medical representatives can check the information on the medical institutions for record.

With the further openness and transparency of information, pharmaceutical representatives who originally existed in many grey areas are gradually transiting to specialization and high standardization. For pharmaceutical enterprises, they are facing a difficult time of transformation.

"For MAH, under the new regulations, it is not allowed to assign drug sales tasks to medical representatives or count the number of prescriptions prescribed by doctors. However, from a practical point of view, this kind of de commercialization can not be achieved overnight. In the short term, the performance indicators of pharmaceutical representatives may still be assessed by pharmaceutical enterprises, such as the increase rate of patients Liang Yuan, founder of a pharmaceutical CSO (contract sales organization) company, told the 21st century economic report that in China, many pharmaceutical representatives have deviated and do not have enough product related professional knowledge. Instead, they mainly focus on "sales with money". If sales performance assessment is canceled immediately, pharmaceutical enterprises will have problems in their own operation. "The implementation of this policy is good for the development of society, and pharmaceutical enterprises should also find ways to help pharmaceutical representatives move to technical jobs."

In addition, Ernst & Young's corporate consulting team believes that the existing CSO model will also be changed. "When the drug marketing license holder authorizes the pharmaceutical representative of CSO, the responsibility for compliance risk is borne by him. Therefore, the cost structure of some CSO enterprises serving multiple companies will also be adjusted accordingly, and the manufacturing enterprises that realize sales through CSO may also reconsider the intermediate management costs and risks. "

However, for MAH commissioned manufacturers, the impact is relatively limited. The relevant person in charge of jiankangyuan's general secretary office told reporters: "because there is no medical representative in the company, but through the regional sales manager to select the pharmaceutical representative for cooperative sales, under this mode, the impact of the new management method on the company is relatively limited."

In Liang Yuan's view, after the implementation of the management measures, the high requirements for professional knowledge will make more than 60% of medical representatives face the dilemma of elimination. "It is also difficult to transfer jobs within pharmaceutical enterprises. At present, R & D positions need high-end talents, production is the development trend of automation, and the sales post is basically saturated. "

take a heavy burden and embark on a long road

As a matter of fact, a number of pharmaceutical enterprises have begun to work on the Internet according to the requirements of the medical representative record system. According to a previous report on pharma.com, these include foreign-funded enterprises such as Pfizer, Roche, Sanofi and AstraZeneca, as well as local pharmaceutical enterprises such as Hewang pharmaceutical.

"Our enterprise started to register one month ago and input the information of relevant personnel into the system. Now it is basically completed, including the marketing department and sales department responsible for formulating the promotion plan of pharmaceutical products, and the medical department personnel who connect with medical personnel to provide product support." A person from the marketing department of a listed pharmaceutical company in Hubei told the 21st century economic report that the number of medical representatives and the final deadline for a single MAH are not clear, and the specific implementation needs to be further observed.

Liang yuanze believes that "for pharmaceutical enterprises, the main coping strategy is to integrate with international standards. In foreign countries, the social status of medical representatives is relatively high, and their main responsibility is to transfer the knowledge of the principle and dosage of new products to doctors. After all, doctors are busy with their work, and the channels and time to take the initiative to learn the latest knowledge are limited. "

"When we choose pharmaceutical representatives for cooperation, we will also form a relatively complete internal assessment model to guide and restrict pharmaceutical representatives to make progress in academic direction. On the one hand, it will help the company's long-term development, on the other hand, it can also avoid external regulatory risks." Said the person.

The practice of neighboring Japan is to standardize the training system for medical representatives. In view of the continuous tightening of the norms of the pharmaceutical representative industry in recent years, medical institutions have continuously strengthened the restrictions on the visits and visits of medical representatives. In view of the low overall level of medical representatives and the promotion of information construction, the Japan Medical Representative Accreditation Center released the "seminar on the reform of business structure · report on the results" in August 2020, which focuses on the review of filing information compared with China The document pays more attention to the training and examination of medical representatives.

In Japan, the evaluation system of pharmaceutical representatives by pharmaceutical enterprises mainly consists of professional evaluation of drugs, the number of talks with doctors, the participation rate of doctors and pharmacists in drug briefing and lecture sessions, the evaluation of doctors and pharmacists, compliance and post marketing monitoring of drugs.

According to Yang Fan's team of Jindu Research Institute, if pharmaceutical enterprises in China carry out or authorize CSO to carry out pharmaceutical academic promotion, they can consider drawing on the management and assessment system of pharmaceutical representatives that have been applied in Japanese pharmaceutical enterprises, and adopt comprehensive academic promotion indicators to evaluate and assess pharmaceutical representatives, rather than taking drug sales as the main indicator.

"The standardization of medical representatives has just begun. The main body of responsibility has been initially defined, and the system filing platform has been constructed. In a sense, the transformation of medicine to high standards on behalf of this special group has just begun. " Liang Yuan concluded.

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