The Pharmaceutical Sales Representative Filing System officially Landed in China, MAH Has the Main Responsibilities
Written by Minhua Chu
Edited by Howard Fields
A work letter signed by Xiangya Hospital, one of the best hospitals in South Central China, was circulated in the China medical industry recently. It concerned one pharmaceutical sales representative (PSR) from a multinational pharmaceutical company who violated the hospital’s rules and entered its outpatient clinics or inpatient area of the Cardiology Department. In response, two products of the company were suspended from being prescribed in the hospital for six months, another product was suspended for three months and the executive of the company was to be interviewed and warned.
The news sparked concern, since it happened so quickly after the regulation “The Management Measures for Pharmaceutical Sales Representatives Filling (for trial implementation) was issued only on September 30 this year by the National Medical Products Administration (NMPA), and was not officially implemented until December 1.
In the late 1980s, PSRs were introduced to China as a new type of job. After training, a group of university graduates majoring in clinical medicine or pharmacy became the first pharmaceutical representatives in China, carrying out academic promotion in hospitals, which not only promoted the prescriptions of the pharmaceutical products in hospitals, they helped doctors to be familiar with the state-of-the-art products and techniques. PSRs also became highly paid and an enviable profession.
With the number of PSRs increasing, however, kickbacks began to appear. Some PSRs have been sentenced for commercial bribery, and many hospitals have prominently displayed signs: PSRs prohibited to enter. Some PSRs chose to switch careers.
The management of PSRs has been gradually enhanced with the introduction of a series of national drug price-control policies in recent years. And, the PSR Filing System was proposed in 2017 in a document issued by the State Council, aiming to regulate academic promotion behaviors. Three years later, in September 2020 after the release of two draft versions, the final regulation finally was formally introduced.
Clarifying the definition and job contents
According to “The Management Measures for PSR Filling (for trial implementation), the PSRs are: professionals who engage in drug information transfer, communication and feedback in the People's Republic of China.
Their work includes:
1 Developing plans for the promotion of pharmaceutical products
2 Delivering related medical information to medical personnel
3 Assisting medical personnel in using the pharmaceutical products
4 Collecting feedback information about clinical use and hospital demand
The Measures also regulate five forms of academic promotion and seven prohibited behaviors for PSRs. The December event of the PSR likely was for violating the prohibited acts. For example, the Measures required the academic promotion to be carried out only after getting approval by the hospitals, and PSRs entering the outpatient/inpatients area were prohibited in many hospitals. That means they are not allowed to enter those areas, regardless of whether have been filed.
MAH is the responsible party
As seen in the definition, the Marketing Authorization Holder (MAH) is the employer or authorized party for the PSR. Other provisions of the Measures further state that the filing is also done by the MAH.
The amended PRC Drug Administration Law (DAL) was approved and took effect on December 1, 2019. A key reform in the revised DAL is full implementation of the MAH system.
According to the new DAL, the drug registration applicant becomes an MAH after obtaining a drug registration certificate, and is responsible for the safety, efficacy and quality control of the drug during the entire life cycle of drug development, manufacture, distribution, sales and clinical use, which also includes the academic promotion activities carried out by PSR. Therefore, the essence of the Measures is to implement the new DAL in drug promotion.
The NMPA, as the agency that regulates the MAH, also manages the PSR who works for the MAH. And, the Chinese Pharmaceutical Society that studies and monitors the drug use is the PSR filing party.
Hospitals are the largest supervisors
So, who supervises the PSR filing?
After filing, the PSR also must follow the hospital's rules for entering the hospital to carry out their work. The rules are generally issued by the local government’s health commission. For example, Shanghai requires the time, place, person be set in advance and with records, and Beijing, Tianjin and Hangzhou have similar provisions. Such rules have not been formally introduced nationwide, however. Some hospitals have their own entry norms, such as choosing one day or half a day per week for receiving PSRs.
Therefore, the largest supervisor of the PSR filing system is the hospitals, and a PSR will be at risk going to hospitals without filing and/or making appointments. The Xiangya Hospital event is an example.
The impact of the PSR filing system
In the PSR filing system, the focus of regulation is from the pharmaceutical companies through the MAH to the downstream distributors, until reaching the PSR. Although it is not a problem for the PSR who is just entering the career or follows the rules, it will be a major concern to some senior PSRs who have not been fully compliant with the rules for a long time.
Some senior PSRs already have good relationships with doctors and no need to enter the hospitals, however, so the filling system may not affect their work much. Therefore, it is a question of whether the filing system can handle the planned effect on PSR management.
On the other hand, the requirement that PSRs are not allowed to sell drugs may have many difficulties and even controversy at the practical level. In fact, almost no PSR will sell drugs directly to doctors or patients, and PSRs also cannot determine the pricing, but is the action of pushing doctors to prescribe the drugs they promote considered as sales? That needs to be clarified not only in the definition, but at the legal level.
A more realistic question is how pharmaceutical companies are to set targets for PSRs. By sales or marketing targets, or specific behavioral indicators such as visits, market research, meetings, or academic activities. Or, perhaps the key issue is not whether sales are made, but whether the behavior is compliant.