China launched a comprehensive anti-corruption campaign in 2024 to rectify misconduct in the medical services and the purchasing and sale of medical products.
The Central Commission for Discipline Inspection has issued several notices emphasizing the need to combat corruption in the pharmaceutical industry.
On May 2024, the National Health Commission, along with 13 other government departments of the PRC, issued the Notice on the Key Points for Correcting Unhealthy Practices in the Field of Pharmaceutical Purchase and Sales and Medical Services in 2024″ (hereinafter referred to as the “Notice”).
The Notice focuses on addressing prominent corruption acts, such as accepting kickbacks and requesting and accepting money and valuables. According to the Notice, China will promote the centralized rectification of corruption in the field of medicine nationwide, continuously improve the management of pharmaceutical agents, and establish a systematic regulatory system to prevent commercial bribery in the field of medical equipment purchase and sale.
On October 11, 2024, the State Administration for Market Regulation, issued the Draft Compliance Guidelines for Healthcare Companies to Prevent Commercial Bribery Risks (hereinafter referred to as the “Guidelines”). These Guidelines were published for public comment. The Guidelines regulate how to identify and prevent anti-corruption.
In Chapter III, the Guidelines list nine types of activities that are considered high-risk commercial bribery:
– Academic Visits and Communications
-Hospitality
-Speaker Fees/Service Fees for HCPs
-Outsourcing
-Discounts, Rebates, and Commissions
-Donations, Sponsorships, and Grants
-Free Placement of Medical Devices
-Clinical Research
-Retail Sales
The Guidelines prescribe that healthcare companies shall regulate the behavior of the enterprise’s pharmaceutical agents, and file and publicize the agents’ information according to the relevant provisions.
The Guidelines define the prohibitions when pharmaceutical companies carry out academic visits and communications:
-pharmaceutical companies assign sales tasks to their agents and medical device promoters.
-pharmaceutical agents and medical device promoters interfere with or influence the rational use of medicinal products by healthcare personnel.
-pharmaceutical agents and medical device promoters use the name of the visit to obtain and collect the medical product dosage information of the medical and health institutions.
-pharmaceutical agents and medical device promoters directly or indirectly to give medical and health personnel property or other undue benefits, to promote the prescription of pharmaceutical products, or to recommend, use, purchase pharmaceutical products.
Regulating the behavior of pharmaceutical agents has become the focus of medical anti-corruption efforts. As early as December 2017, the State Food and Drug Administration and the National Health Commission jointly issued the “Measures of Registration and Filing Management of Pharmaceutical Agents (Draft)”(“Measures”), which clarifies that agents are not allowed to undertake the task of selling medicines.
By December 1, 2020, the Measures officially landed on the implementation, from the proposal to the solicitation of opinions and then to the official implementation of the system, it took nearly four years. Under the Measures, there are four duties, five promotion methods, and seven prohibited circumstances for the agents.
| Duties | Preparing plans and programs for the promotion of pharmaceutical products; Delivering information related to pharmaceutical products to medical staff; Assisting medical staff in the proper use of the enterprise’s pharmaceutical products; Collecting and providing feedback on the clinical use of medicines and demand information of the hospital. |
| Promotion methods | Face-to-face communication with the medical staff in person in the medical institutions; Organizing academic conferences and lectures; Providing academic materials; Communication through the Internet or teleconferencing; Other forms agreed by the medical institution. |
| Prohibited circumstances | Carrying out academic promotion and other activities without filing; Carrying out academic promotion and other activities without the consent of the medical institution; Undertaking sales of medicines and implementing sales practices such as collection and processing of purchase and sales notes; Participating in the counting of the number of drug prescriptions issued by doctors; Providing direct donations, funding, and sponsorship to departments and individuals within the medical institution; Misleading doctors in the use of medicines, exaggerating or misleading the efficacy, concealing information on known adverse reactions to medicines or concealing information on adverse reactions feedback of doctors; Other behaviors that interfere with or affect the proper use of medicines in the medical institution. |
In 2024, apart from the nation-level regulations, local health commissions in Jiangxi, Hainan, Shanghai, Fujian, and various other provinces and cities released notices for corrective actions specifically targeting the pharmaceutical industry.
I. Jiangxi province issued the “Administrative Measures for the Professional Conduct of Pharmaceutical Agents (Trial Implementation)”
This document not only stipulates a negative list of behaviors of pharmaceutical agents, but also establishes a list of prohibitions for the staff of medical institutions in receiving pharmaceutical agents, including violation of contact with unrecorded medical agents, violation of counting of the number of drug prescriptions, acceptance of gifts and gratuities or other improper benefits, and acceptance of donations and sponsorships or participation in various activities paid for by medical companies or agents.
If the staff of medical institutions violates these prohibitions or contacts with pharmaceutical agents in private, the staff shall be included in misconduct assessment management.
Medical agents who violate the provisions and refuse to correct their behavior shall have the authorization to carry out academic promotion and other activities be suspended, and undergo job training; the authorization can be reconfirmed after passing the examination; in serious cases, the agent shall be dismissed and the agent’s filing information shall be deleted.
II. Hainan province issued the “Interim Provisions on the Management of Reception of Pharmaceutical Agents by Public Medical Institutions”
If pharmaceutical agents violate the relevant provisions, medical institutions shall remind or interview the pharmaceutical enterprises involved or their agencies depending on the circumstances. In serious cases, the health administrative department shall report to the market supervision, medical insurance and other relevant departments at the same level, and handle the matter according to law and regulations. If a crime is suspected, it shall be transferred to the judicial authorities.
III. Shanghai city issued the “Nine Guidelines for Staff Integrity in Medical Institutions”
When pharmaceutical enterprises and hospitals receive pharmaceutical agents, the reception process shall meet seven requirements (at a scheduled time, fixed location, and with the designated person, appointment, compliance process, record, and monitor).
IV. Fujian province issued the “Interim Provisions on the Management of Reception of Pharmaceutical Agents in Public Medical Institutions”
If a medical institution discovers that a pharmaceutical agent conducts business activities without registration and appointment at the medical institution or conducts business activities in violation of the rules for the third time, the agent shall be prohibited from entering the medical institution.
When conducting academic promotion activities in medical institutions, pharmaceutical agents shall first register and file with the relevant departments, and report to the office of the medical institution (or the department designated by the medical institution) for unified management. In principle, each agent shall register at least once a year. Pharmaceutical agents shall not conduct academic promotion activities in medical institutions without registration.
V. Hubei province issued Notice on Further Regulating and Strengthening the Management of Pharmaceutical Representatives
The medical institution shall establish an integrity record file for pharmaceutical agents and implement appointment management for pharmaceutical agents to enter medical institutions.
VI. Hunan province issued the “Notice on Strengthening the Management of Pharmaceutical Representative Registration and the Reception of Pharmaceutical Representatives by Medical Institutions”
Pharmaceutical agents conducting academic promotion and other activities in medical institutions shall abide by relevant regulations of the health department, and carry out these activities within the authorized medical categories, therapeutic areas, and regional scope after obtaining the consent of the medical institution.
The staff of medical institutions shall strictly abide by the regulations on the reception of pharmaceutical representatives. Staff of medical institutions shall not have unauthorized contact with pharmaceutical agents or provide pharmaceutical agents with related information like product sales.
Ever since the beginning of August 2023, there have been daily reports of medical system officials being probed and removed from their positions, part of whom are involved in bribery from the pharmaceutical agents.
For example, Shaanxi Province announced on October 20 2023that it has received 2,521 tip-offs of medical corruption this year. A total of 937 people has been investigated and 3,470 “red envelopes” (bribes) from both the patients and the pharmaceutical agents returned.
On June 18, 2024, the Hainan Provincial Commission for Discipline Inspection released 11 cases of irregularities and corruption in the Hainan health system.
China’s determination to combat corruption in the medical field is reflected in central regulations and successive documents from local provinces.
In a whole, pharmaceutical agents face stricter surveillance and regulation at all levels. Compared to the previous incomplete system, the strong will of crack down the anti-corruption and the improved regulatory framework push agents to operate in a proper and compliant manner.
Alina Quach, IDI Country Expert for agency and distribution in China
