The Hubei provincial market supervision administration has released a set of guidelines titled “Anti-Commercial Bribery Compliance Management” for medical industry enterprises within the province. The document is designed to guide pharmaceutical companies in developing a culture of compliance and fair competition, establishing robust anti-bribery management systems, and mitigating legal risks associated with commercial bribery. The guidelines apply to Marketing Authorization Holders (MAHs), contract research, development, and manufacturing organizations (CRDMOs), contract sales organizations (CSOs), and pharmaceutical distribution enterprises.
Commercial bribery is defined as the illegal transfer of financial or other benefits. Under national laws, including the Drug Administration Law, pharmaceutical companies that refuse or obstruct investigations into suspected commercial bribery will be ordered to correct their actions. Individuals may face fines up to RMB 5,000, while companies may face fines up to RMB 50,000. For those found to be bribing for trading opportunities or competitive advantages, illegal gains will be confiscated, and fines ranging from RMB 100,000 to RMB 3 million will be imposed. In severe cases, the business license may be revoked. For kickbacks or other improper benefits in drug purchases and sales, illegal gains will be confiscated, and fines between RMB 300,000 to RMB 3 million may be imposed, with potential business license revocation.
Individuals found bribing state officials will be banned from employment for life. Criminal penalties, including imprisonment for 3-10 years, may be applied based on the amount of bribery and the severity of the circumstances.
The guidelines encourage pharmaceutical companies to report suspected commercial bribery by other operators and to maintain market competition order. Companies that voluntarily confess, cooperate with investigations and punishment, and show meritorious service will be given lighter or mitigated punishment. Companies are also encouraged to assess the risk of commercial bribery, particularly in areas such as expenses reimbursement, commission payment, and academic conferences. Regular audits of compliance management systems and compliance training are recommended.- Flcube.com
