The China Office and the State Council issued the programmatic document of the pharmaceutical industry, “Opinions on Deepening the Reform of the Examination and Approval System and Encouraging the Innovation of Drug Medical Devicesâ€, compared with the State Council’s review on the reform of pharmaceutical medical devices on August 18, 2015. The Opinions on the Approval System, which added the requirements for medical representatives, also attracted the attention of many small partners. Some of the small partners answered the questions in the background, and shared the views of the individual here:
1. What changes have been made from the CFDA's consultation draft to the state-run documents?
Let us first look at Article 27 of the State Administration Document:
(27) Standardize the academic promotion of drugs. The holder of the drug marketing license shall file the list of medical representatives on the website designated by the food and drug supervision department and make it public to the public. The medical representative is responsible for the academic promotion of medicines, introducing medical knowledge to medical staff, and listening to suggestions for clinical use. The academic promotion activities of medical representatives shall be conducted in public and filed with the designated department of the medical institution. Medical representatives are forbidden to undertake drug sales tasks, and it is forbidden to provide medical representatives or related enterprise personnel with the number of prescriptions prescribed by doctors. If a medical representative misleads a doctor to use a drug or conceal an adverse drug reaction, he shall seriously investigate and deal with it; if a drug business operation is carried out in the name of a medical representative, the drug shall be investigated and dealt with according to the illegal operation of the drug.
The "Opinions on Deepening the Reform of the Examination and Approval System and Encouraging the Innovation of Drug Medical Devices" issued by the Central Office and the State Council are actually the three drafts of the consultation papers issued by the State Food and Drug Administration on May 11th, No. 52 and No. 53. The improvement and summary of Document No. 54, in the National Food and Drug Administration, May 11th, No. 54 “Related Policies for Encouraging Drugs and Medical Devices to Innovate and Implement the Whole Life Cycle Management of Pharmaceutical Medical Devices (Draft for Comment) Six articles correspond to Article 27 of yesterday’s document:
6. Standardize academic promotion behavior. The medical representative is responsible for the academic promotion of new drugs, introducing new drug knowledge to clinicians, and listening to the opinions of clinical use of new drugs. It is forbidden for medical representatives to undertake the task of drug sales, and it is forbidden for medical representatives to contact with doctors privately. It is forbidden for anyone in medical institutions to provide the number of prescriptions prescribed by doctors to pharmaceutical representatives, pharmaceutical production and operation enterprises. The academic promotion activities of medical representatives in medical institutions shall be conducted in public and filed with the designated department of the medical institution. Medical representatives who mislead doctors to use drugs and conceal adverse drug reactions should be seriously investigated. The holder of the listing license (drug production enterprise) shall record the list of medical representatives on the website designated by the food and drug supervision department and make it public to the public. Where the drug business activities are carried out without being publicly disclosed and in the name of a medical representative, the relevant departments shall investigate and deal with the illegally operated drugs by the relevant enterprises and medical representatives.
It can be seen that the changes are concentrated in the following two points, mainly to improve the original CFDA opinion draft:
1. The original "prohibition of medical representatives to contact with doctors privately" was removed, adding "medical representatives misleading doctors to use drugs or conceal adverse drug reactions, should be seriously investigated."
“Prohibiting medical representatives from contacting doctors privately†is not only difficult to implement, but also too extreme. The current change confirms the positive meaning of the normal communication between medical representatives and doctors, but also emphasizes that medical representatives should not mislead doctors to use drugs, such as hyperindications. Propaganda, avoiding adverse reactions, etc. should all be easy to touch the red line.
2. "If the pharmaceutical business activities are carried out in the name of a medical representative without the disclosure of the case, the relevant departments shall investigate and deal with the relevant enterprises and medical representatives in accordance with the illegal operation of the drugs." If it is changed to "the pharmaceutical business activities in the name of medical representatives, the illegal drug management shall be investigated and dealt with." ."
This point is also a perfection of the original. On the surface, it has been removed from the "undocumented disclosure". It seems to be more strict. The actual policy makers should focus on the word "pharmaceutical business activities". In fact, medical representatives as individuals have been It is impossible to carry out drug business activities, only enterprises can, because the original draft is formulated by CFDA, and the current changes are more in line with business management requirements.
Second, the medical representative "can not sell drugs", has been so no need to panic
Today, "prohibited medical representatives selling drugs", "prohibited medical representatives selling drugs", "medical representatives can not sell drugs", "medical representatives selling drugs illegal" and other similar texts are found in various traditional media and self-media titles, enough Attracting attention has aroused the attention of the pharmaceutical industry for many years, so that everyone pays more attention to the policy, but it has also caused panic among many newcomers in the industry, thinking that the career path has been blocked, and even some individuals are planning to change careers.
"If the pharmaceutical business activities are carried out in the name of medical representatives, the illegal management of drugs shall be investigated." This is only the state office's emphasis on documents. As I said before, it is illegal for pharmaceutical representatives to conduct pharmaceutical business activities as individuals. In the past few decades, there have been many representatives or companies in various sports-style rectification medical environments that have been investigated and fined by industrial and commercial enterprises for allegedly carrying out “business activitiesâ€, even if the offices of pharmaceutical companies are not registered in the local industry and commerce. It is possible that the local authorities have been illegally investigated and dealt with. This is a precedent for many companies. Here is not an example.
Therefore, even some personal drug agents, whether they are big bags or small bags, although the behavior is to sell drugs, but has always relied on a certain enterprise to avoid the suspicion of "pharmaceutical business activities."
For the medical representatives of foreign companies, there is no such behavior as drug management, because although there are sales indicators, in the compliance, it is also required to promote the behavior "do not promote the prescription for the purpose."
Therefore, medical representatives are not allowed to carry out pharmaceutical business activities. They have always been so demanding, and why should they panic.
Third, the state-run documents clarify the "may" and "not for" medical representatives
There are more than 7,000 pharmaceutical companies in China, large and small, and their respective enterprises have different requirements for medical representatives. The number of practitioners who are represented by medical representatives is nearly 3 million. Different training and education have also resulted in the quality of practitioners. There are also differences in the promotion models of foreign companies and domestic enterprises. All kinds of situations have caused a unified standard regardless of the external view of the profession or the definition of the professional behavior of the practitioners.
As a profession, the medical representative has officially entered the national professional ceremony in the same way as the United States and Japan. The state has successively issued a series of documents and has carried out programmatic requirements for many times. This state-run document further clarifies the medical representative. "Can be" and "not available".
For example, “medical representatives are responsible for the academic promotion of medicines, introducing medical knowledge to medical staff, and listening to advice on clinical use.†This is a restatement of the profession’s functions from the national level, affirming its positive significance. To do it, you don't have to look at other people's eyes at all, visit a doctor and sneak a thief.
At the same time, some can't do it. For example, if a medical representative misleads a doctor to use drugs or hides adverse drug reactions, he should seriously investigate and deal with them;
In terms of management, the requirements are dual records of the drug supervision system and the medical system. In addition to the filing of the drug representative system by the enterprise in the drug supervision system, it is also required to be filed in a hospital that needs to be promoted. This Shanghai is already in the process of implementation.
Fourth, the constraints on the promotion of representatives are mainly in the first-tier cities.
Whether it is the filing of medical representatives or the restrictions on specific promotion behaviors, the impact is mainly on the first-tier cities such as Beishangguangshen and Shenzhen, but for other cities, especially the prefecture-level and county-level markets, the impact is small. Rectification, many times the medical representatives did not dare to go to the hospital for promotion, and ultimately did not affect the transformation of the promotion model.
The norms of non-first-tier cities are also the further refinement of the system, and more importantly, the promotion of the pharmaceutical circulation system and the reform of the medical system, and not just the norms of the behavior of medical representatives. At certain times, many commodities carry the goods that do not belong to it. More functions, the house is not used to live, the medicine is not used to treat the disease, this phenomenon is difficult to rely on the behavior of the sales lady and the medical representative.
How do we face ourselves in the face of new regulations? How is our business adjusted? Many people emphasize that improving their academic level and improving their value to doctors is only one aspect. What we need to realize is that self-improvement is often difficult, and each person is required to have a high self-driving force. For the whole group, this is unrealistic. For example, GSK claims that the industry's transformation and promotion model is the earliest, and the indicator evaluation is cancelled. But in all fairness, is the medical representative of GSK more professional than other foreign companies? Is there a higher value in the minds of doctors? The answer I think everyone knows, then why is the professionalism of medical representatives not significantly improved in this system that meets the requirements of the system?
Therefore, this is also the case from pharmaceutical companies. It is not only expected to be a change in the representative, but more importantly, the transformation of the entire system, such as the transformation of the promotion model, the advancement of digital projects, the repositioning of the sales support department, and so on.
Industry norms are the trend of the times, no need to panic, from the state's requirements for "can be" and "can not be", against their own promotion behavior, it is easier to identify their career direction.
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