The Administrative Measures of Medical Representative Registration issued at the end of September 2020 after two rounds of soliciting public opinions has aroused a heated discussion in the pharmaceutical industry. With the Administrative Measures of Medical Representative Registration (Trial) coming into effect on 1 December 2020, the medical representative registration platform was also launched. Pharmaceutical companies have taken action to actively adapt to the changes and challenges brought by the new rules. However, the new rules for medical representatives currently only applicable to pharmaceuticals are not yet in force in the medical device sector. However, it is important to wait and see whether medical device representatives will also be included in the registration scope in the future.
In the Pharmaceutical Administration Law newly revised in 2019, it is clearly provided that, China implements a marketing authorisation holder-based system for the administration of pharmaceuticals and such marketing authorisation holders are responsible for the whole process from research to the use of pharmaceuticals. The newly issued measures also aligns with the Pharmaceutical Administration Law.
According to the requirements of the new rules, companies as marketing authorisation holders for pharmaceuticals need to assume the management responsibility of their medical representatives. Such management responsibility is not limited to registration and filing, but also, in fact, covers the whole process of management of medical representatives from hiring to performance. When appointing a medical representative, the company should sign a labour contract or an authorisation letter with the medical representative to specify the category of pharmaceuticals and treatment fields they are authorised to promote. After that, it is necessary to register and file the medical representative’s information in time on the registration platform designated by the NMPA and keep follow-up information up to date to ensure the authenticity of the registered information. In addition, the company should also publicise the information of the medical representative on its website or the website of relevant industrial associations to enhance the transparency and accessibility. At the same time, while the medical representative performs his/her duties and carries out academic promotion activities, the company should pay close attention to the behaviour of the medical representatives and perform strict management responsibilities for the medical representative. When finding that the representative conducts any behaviour prohibited by the new rules or other inappropriate behaviours, the company should correct it immediately.
In order to fulfill the management responsibilities for medical representatives, the company needs to identify qualified medical representatives. According to the official explanation, medical representatives who are required to be registered are not limited to the staff in the position of medical representative set by the company. The marketing authorisation holder of pharmaceuticals are required to register and manage any person who needs to carry out academic promotion activities. In other words, whether it is necessary to register a medical representative of a company should not only depend on whether the person has the title of medical representative, but rather his/her specific job duties. This can be done by checking against the work nature of a medical representative, as well as the four areas of work content and five specific ways of carrying out academic promotion activities under the new rules to determine whether the job engaged in by the employee falls within the work scope of a medical representative as set out by the medical representative registration system.
In the process of selecting qualified medical representatives, a company may conduct an overall analysis first, that is, use the existing job description as a reference for the preliminary screening of qualified medical representatives and then comprehensively evaluate qualified medical representatives in combination with employees’ self-examination.
In terms of an employee’s self-examination, firstly, the company may carry out introduction and training on the medical representative system so that employees are aware of the new rules, especially the personal responsibilities and duties of medical representatives. Then, by taking the work content of medical representatives and the academic promotion forms stipulated in the new rules as two focuses, the company may design questionnaires and distribute them to employees to fill in. Finally, according to the results of the questionnaire, the company will be able to identify the employees who need to be registered and filed as medical representatives.
In this way, not only will it establish a culture that adapts to the new rules of medical representatives in the company and popularise the respective prohibited behaviours of pharmaceutical marketing authorisation holders and medical representatives, but it will also help to determine the employees who need to be registered through subsequent questionnaire analysis. It will also assist in gaining further information about the job duties related to medical representatives of each employee, the proportion of different work duties, the products they are responsible for and the proportion of the main ways of conducting academic promotion activities, etc.
It can be seen from the new rules that the state is now strengthening the regulation of medical representatives and has delegated the responsibility to relevant companies, by placing higher requirements on them. Although the responsibility has been delegated to the companies, in order to ensure that the companies really put the management responsibilities of medical representatives into practice, the state has also increased supervision on the management of medical representatives from the medical institution level.
The new rules clearly provide that medical institutions can check the registration information of medical representatives on the registration platform, and should not allow medical representatives who have not been registered to carry out academic promotion activities and other related activities to their medical personnel or pharmaceutical personnel. At the same time, medical representatives should obtain the consent of medical institutions before carrying out academic promotion activities, but there are no specific requirements on the form and content of such consent. This also leaves certain space for medical representatives to diversify the methods of carrying out academic promotion activities.
With the new rules coming into effect, China has officially ushered in the medical representative 2.0 era. Although many new requirements are imposed on companies, it also provides an opportunity for them to collate their own medical representatives and enhance their compliance. The promulgation of the new rules is in line with the current general direction of China’s strengthening of the management and integrity in medical purchases and sales. At present, the registration requirements and the platform are only applicable to pharmaceutical companies. However, it is worth paying close attention to whether, in the future, the medical representative registration system will be introduced in the field of medical devices, another important part of the medical purchases and sales sector.
Calvin Lee is a partner at AllBright Law Offices
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