The logic behind the new version of the pharmaceutical representative filing method: can the pharmaceutical representative bear the sales target?

On June 5, 2020, the Comprehensive Division of the State Drug Administration publicly solicited the opinions of the Measures for the Administration of the Record of Pharmaceutical Representatives (Trial) (Draft for Comments).
in fact, the "most stringent" "medical representative registration and record management measures (trial) (draft for comments)") was introduced on December 22, 2017, and the new "Pharmaceutical Representative Filing Management Measures (Trial) issued, more than two years since the last consultation." And these two years, the pharmaceutical industry changes:
the pharmaceutical management department has carried out reforms, from the CFDA change to today's NMPA, food and drug management separately, not only to highlight the state's attention to drugs, but also to deepen the "tube service" a strong embodiment, so that professional people do professional things. At the same time,
, in the pharmaceutical sector, generic drug consistency evaluation, band procurement (expansion of varieties, expansion of cities, expansion of batches, expansion of the form (injection), expansion of the field (devices) and other policies are also in full swing. The unfair competition in the field of
pharmaceutical purchase and sale has gradually become a hot topic of social concern. In the frequent exposure of drug purchase and sale corruption cases, the state three orders five Shen, but in essence it is difficult to correct the industry "subliminal rules", 9 ministries, 10 ministries repeatedly issued a strict investigation of drug purchase and sale of false false false increase "three false" invoices and other medical enterprises.
health care, the establishment of the National Health Care Administration in 2018, "three powers concentrated", "soul cut price" and other initiatives are invincible, health insurance payment DRG trial is to make hospital drug companies busy group turn.
medical care, whether it is graded diagnosis and treatment or public hospital performance reform, or to build a national regional medical center and other documents are making the three-medical linkage in 2009 to deepen the important pusher of medical reform, medical care, medical insurance, medicine-based "three-doctor linkage" gradually formed a closed loop.
and the above factors actually constitute the pharmaceutical representative record management system appeared in the large rhesus background. In particular, it is important to suggest that, in the very important field of medicine, medical representatives, for many historical reasons, are often representatives of "derogatory terms" and even form the so-called "medical representative problem". Therefore, how to define the professional identity and behavior of medical representatives has become an important issue of government and social concern. Pharmaceutical representatives management reform industry norms are imperative, pharmaceutical representatives management methods called out, I believe that in the near future, the "Measures" will quickly land.
to say the change in the whole approach. By comparison, it is found that the 2017 medical representative registration and record management methodand and the 2020 medical representative filing management method is still some different.
first of all, is the main unit of the text is not the same. The year 2017 is a joint issue by the General Office of the State Food and Drug Administration and the General Office of the State Health and Planning Commission, while the 2020 report ingon is the State Drug Administration (NMPA).
second, the name of the draft is different. In 2017, it will be called the Measures for the Administration of the Registration and Filing of Medical Representatives, and by 2020, it will become the Measures for the Administration of the Record of Pharmaceutical Representatives. From the "registration record" change disso-recorded, although only two words, but still can send some signals, that is, the overall attitude is more relaxed than before. This will be stated in detail later.
again, from the overall text, the new version of the document is also more streamlined and competent. The 2017 edition has 20, 3029 words, and the 2020 edition is 18, 2203 words, more than 800 words less overall. What does that mean? The reason behind this is that the national level of pharmaceutical representatives of this profession more recognized, two years ago if the approach strictly enforced, the industry will not have pharmaceutical representatives exist, pharmaceutical companies have no way to carry out innovative product marketing, which is the national advocacy of the pharmaceutical power, research and development of innovative power concept is obviously inconsistent.
we also see that this outbreak, the state saw the pharmaceutical enterprises, whether it is social donations or pharmaceutical practitioners of personal donations have played a key role, can be said to be a credit, on the other hand, affected by the epidemic, employment problems are increasingly prominent, the government work report put forward that employment protection is the first big plan of people's livelihood. Moreover, there are more than 8 million college graduates this year. As a result, the 2020 version of the approach is clearly a lot of relaxed requirements compared to 2017, of course the core is still the same.Article 2 of the
Measures, the 2020 edition is missing the expression "Import drug distributors may act as overseas drug licensing holders responsible for the record management of the registration of pharmaceutical representatives", nor does the expression "pharmaceutical sales staff do not belong to the pharmaceutical representative and are not included in the management of these Measures". We see no change in the same filing sourcing of pharmaceutical representatives or for drug licensing holders. The new method in which the general agent of imported drugs may act as the holder of the overseas drug listing license is responsible for the registration and record-keeping of the pharmaceutical representative is removed.
so it is understandable that the new version of this approach is not regulated. But for CSO agencies acting for offshore drugs, the standards may actually be more stringent. Because the state only recognizes the drug market license holders, this is the unchanging theme, agent imports, follow-up accountability companies are not in the country, in fact, there is no way to blame.
of course, this kind of CSO is not very profitable now, also gradually not willing to take over the agent. That is for our domestic pharmaceutical companies CSO companies, can do the pharmaceutical representative's record? It is possible to judge by documentation, from the method can be seen, the 2020 version of the pharmaceutical representative for the record of the trial draft, there are 11 mentioned authorization, that is, when our drug market license holder authorized to CSO, then as long as the CSO can reach a consensus with the drug market license holder, the drug listing license holder can assume, then the authorization to cSO's pharmaceutical representative, to achieve all the compliance, in theory, it means that of course all the risk of compliance with the drug licensing holder.
as for the drug market licensing holders in the face of the future of the introduction of this policy is willing to take such a large risk to the CSO organization? A question mark is needed. As anyone concerned knows, in May this year the nine ministries issued a crackdown on CSO false invoices notice. I believe that CSO will be more and more difficult, the enterprise self-building team is also reasonable, but not the same as it will disappear.
in terms of the content and qualifications of the profession, we see that article 3 of the 2017 edition provides that pharmaceutical representatives may communicate with medical personnel through the following forms, and also stipulates that before engaging in activities such as academic promotion, the holder of the drug listing license shall apply to the medical institution (or issue an invitation to the out-of-hospital activity) and obtain the approval of the medical institution before it can proceed.
and Article 3 of the 2020 new version provides that pharmaceutical representatives may carry out activities such as academic promotion in the following forms, removing the requirement that drug licensing holders need to apply for and obtain approval from medical institutions. This aspect illustrates the need for the 2020 edition to recognize the need for medical representatives to undertake academic activities. There is no doubt that the Government recognizes the academic value of medical representatives. On the other hand, the 2017 version of the approach will provide that medical representatives can communicate with medical personnel through the following forms to the new version of the 2020 regulations pharmaceutical representatives can carry out academic promotion and other activities, from the subject of the provisions from medical personnel to carry out academic activities, once again, the government is to regulate the behavior of medical representatives, the transmission of academic value. It is further evidence that the Government has relaxed the conditions allowing medical representatives to do academic promotion. Explain that the real medical representatives are academic-oriented, technology-oriented, to assist medical personnel to rational use of drugs.
we compare the findings, the 2017 registration and filing method clearly for the medical representative's academic qualifications made the corresponding provisions, at the same time clear lying for college or higher vocational, must have more than two years of work experience in the field of medicine, the new version of the 2020 method removed two years of work experience, the medical representative's academic qualifications, professional, work experience decision to the pharmaceutical enterprises to determine. This shows that in the future, as long as you have experienced pre-job training, and have a registration record, and your ability to match the position, in line with the relevant provisions of the profession, you can engage in pharmaceutical representative. As for the ability and position how to evaluate the decision is still in the pharmaceutical companies,
but not that the pharmaceutical representatives do not need to have these professional qualifications or for the majors have relaxed requirements? Maybe not yet. The document clearly states that medical representatives should set the requirements for academic qualifications and work experience. According to the current industry situation, pharmaceutical companies will only be more and more stringent screening of pharmaceutical representatives. For those who are interested in entering the pharmaceutical representative or pharmaceutical industry, then as long as the enterprise assessment meets the requirements of the enterprise's academic qualifications, work experience, professional, etc., through the pre-job training, then the state is agreed to become a pharmaceutical representative, and we found that the 2020 version of the scheme proposed that the drug listing license holders can entrust social institutions to carry out training, and the authenticity of the training records are responsible. In fact, the essence is clear that the pharmaceutical representatives are more and more professional, is to be trained to take up the post, this is a basic threshold.
the medical representative's practice content and qualifications with the industry standardization, is gradually returning to its original value, just like the pharmaceutical industry, the root source or return to value, do value medical representatives is the government advocated. Through this provision we can not easily find that the future of pharmaceutical representatives will actually be more and more demanding, because the policy forces pharmaceutical companies to choose high-quality pharmaceutical practitioners, we also predict that the number of pharmaceutical representatives will not be as brutal as before expansion, because the industry is highly intensive, our practitioners will only be more and more demanding, according to japan's 120 million people, only 5-6 million pharmaceutical representatives of the projections, we currently conservative between 200-3 million, then 1.4 billion people need how many pharmaceutical representatives?
the most important filing body is the drug licensing holder. The 2020 version highlights the primary status of drug listing license holders and the first filing of the person responsible, all pharmaceutical representatives filing the first person responsible is the drug listing license holder, while adding the drug listing license holder to its filing information authenticity, equivalent to the drug listing license holder made a commitment on the platform. The 2020 version of the measures provides that pharmaceutical representatives for the record has a clear entrusted department, the State Administration of Drug Administration commissioned the Chinese Pharmaceutical Society to build and maintain. In the future, all the information filed for publication, documents, regulations and publicity will be issued through the Chinese Pharmaceutical Society.
also a very important role of the filing platform, the company's drug listing license holders and their pharmaceutical representatives illegal information release, announcement policy, provided to public inquiries and so on. We also see the change mentioned in the medical representative's filing information on the change of the drug listing license holder from the original 20 working days to complete the record of the pharmaceutical representative information changed to 30 working days, and proposed that the pharmaceutical representative's employment activities in medical institutions should be carried out publicly, and comply with the relevant provisions of the health and health departments, after obtaining the consent of medical institutions, can be with their medical personnel to carry out academic promotion activities.
this is actually quite vague. That future pharmaceutical representatives in the medical institutions of all the business activities should be carried out in public, so whether the hospital has to open a specific time or a specific notice to the pharmaceutical company's plans to show everyone? But does a small department also require medical approval? How can medical representatives go to the hospital to visit medical personnel? It's impossible to do it. After the outbreak of the hospital heavy task, the hospital simply do not have the time to deal with these things, so I think this provision is vague. Although a paper document is said to be the record of pharmaceutical representatives, in essence, all the responsibilities and difficulties to the pharmaceutical enterprises, for drug market licensing holders, this is also a whole body, with a volume policy, no pharmaceutical enterprises are winners, now the record of pharmaceutical representatives is imminent, drug listing license holders face a difficult problem.Article 15 of the
2017 version of the measures clearly states that pharmaceutical representatives shall not undertake the task of drug sales, shall not participate in the counting of the number of prescriptions of drugs issued by individual doctors, shall not directly sell food and medicines, shall not collect and handle purchase and elimination bills shall not engage in commercial bribery, shall not directly provide donation spending to departments and individuals in medical and health institutions, shall not mislead doctors about the use of drugs, shall not exaggerate or mislead the efficacy of drugs, and shall not be used to exaggerate or mislead the adverse effects of for-profit drugs. If the violation will be public, and will report to the personal credit department, and to work out of the training for a month, but also to pursue the law. Article 13, paragraph 14, of the
2020 version of the Measures, directly does not change to the drug market license holder in the following circumstances, encourages the pharmaceutical representative to engage in illegal and illegal behavior, assigns sales tasks to the pharmaceutical representative, requires the pharmaceutical representative to collect and process the purchase and sale of bills, requires the pharmaceutical representative or other personnel to count the number of prescriptions of medicines issued by the doctor, and provides false information in the record. Remove if the violation will be public, and will report to the personal credit department, and to work out of the training for a month, but also to pursue the law.
both the 2017 and 2020 releases suggest that drug licensing holders and pharmaceutical representatives cannot be sold. So in the end, can the pharmaceutical representative take on the sales task? What I see is that there are no companies that don't take on the sales task, and I think this article is debatable.
the proposed can not assume the sales task, more for those non-genuine pharmaceutical representatives and gold sales of pharmaceutical enterprises, but which industry has no target? Countries have GDP targets, we are familiar with the G Division also has goals, the region does not bear the same target. Method snot let me bear the indicator, that indicator is attributed to the director, the same medical representative in the region can get the indicator less? Need to be clear is that the sales indicators are not equal to sales tasks, the method is not to assume sales tasks, did not say that there can be no sales indicators. The task is the deposit and sale, and the indicator is the target. The country is more do not want to see because of the encouragement of drug licensing holders so that pharmaceutical representatives "slowly change", so for the pharmaceutical companies do not do academic promotion, there is really no room, used to say rebates, now the national level endorsement, with the amount of procurement and health insurance payments as super-pharmaceutical representatives, in fact, the drug space squeeze is really strong. On the one hand, it must be admitted that this kind of thing is difficult to solve at once, it does exist, on the other hand, only a few enterprises can exist. For example, the fierce competition for innovative drugs will lead to many pharmaceutical representatives of the movement of deformation, but this is not the problem of pharmaceutical representatives.
of course, the pharmaceutical industry as a whole is indeed getting better, this is the value of every pharmaceutical person engaged in this line of reflection, but also the first thought. In the future, we will continue to see our sales targets, we will continue to pursue our goals, this will continue to exist, the state does not encourage the use of improper means to increase sales tasks in order to buy drugs, this road country will not allow will also be curbed.