Chinese Regulators Publish Final Anti-Corruption Guidelines for the Healthcare Industry

On January 14, 2025, the State Administration for Market Regulation (SAMR, 国家市场监督管理总局) published the Compliance Guidelines for Healthcare Companies to Prevent Commercial Bribery Risks (the Guidelines, 医药企业防范商业贿赂风险合规指引). The Guidelines are the final version of the Draft Compliance Guidelines for Healthcare Companies to Prevent Commercial Bribery Risks (the Draft or the Draft Guidelines) which were published for public comment on October 11, 2024. The finalized Guidelines took effect upon publication.

The Guidelines compile the mainstream interpretation of China’s anti-corruption regulatory framework, similar to the Foreign Corrupt Practices Act Resource Guide published by the U.S. Department of Justice and the U.S. Securities and Exchange Commission. The Guidelines are generally consistent with the draft published in October and with best practices in other jurisdictions.

This Advisory will highlight key changes from the Draft Guidelines to the final version, particularly with respect to the payment of service fees to healthcare professionals (HCPs), sponsorships, and the placement of capital equipment. We have also prepared an English translation of the Guidelines, as well as a redline document showing changes from the Draft Guidelines.

Service Fees for HCPs (Article 18)

In a significant change from the earlier draft, the Guidelines remove lecturing and surveys (e.g., market surveys) from the examples of services provided by HCPs in return for compensation. While the Guidelines do acknowledge corporates’ need to engage HCPs, this change indicates that the SAMR may hold a restrictive attitude toward the type or scope of service fee arrangements. Companies should therefore pay close attention to their controls around service fee engagements with HCPs.

Sponsorships (Article 31)

The Draft Guidelines provided that healthcare companies should avoid directly providing sponsorships to healthcare institutions, departments within healthcare institutions (e.g., clinical departments within a hospital), and individual HCPs. The Guidelines add a further restriction that healthcare companies should also avoid indirectly providing such sponsorships. This appears to reflect growing regulatory attention to the practice of paying sponsorships to industry associations that act as pass-through entities for a specific hospital, hospital department, or HCP, without providing material services or otherwise contributing value. Companies should therefore review their sponsorship approval and monitoring processes to account for this risk.

Sales Targets for Medical Representatives (Article 13)

The Draft Guidelines appeared to prohibit healthcare companies from assigning sales targets to medical representatives, leading to some concern within industry. The Guidelines clarify that this prohibition applies to “instructing medical representatives to conduct sales activities such as the collection of payments and handling … bills,” rather than traditional sales volume targets. This understanding that sales volume targets are permissible is consistent with the relevant regulations on management of medical representatives published by the National Medical Products Administration, including the Administrative Measures for Management of Record-Filing for Medical Representatives (Trial Version) (医药代表备案管理办法(试行) and the Draft Administrative Measures for Management of Medical Representatives (医药代表管理办法（征求意见稿）).

Business Hospitality (Article 16)

The Guidelines remove the Draft’s blanket prohibition on using business hospitality to obtain business opportunities or competitive advantages. This appears to be an acknowledgement that reasonable business hospitality is sometimes provided as part of or along with promotional activities, which are intended to obtain business opportunities or competitive advantages.

Free Placement of Medical Devices (Article 36)

Under the Draft Guidelines, the free placement of medical equipment was defined as the “provision of medical devices to healthcare institutions free of charge based on legitimate purposes of improving product use and pre-market clinical trials.” The Draft further provided that these legitimate purposes included:

• Collection of feedback on product research and development and improvement
• Evaluation performed by healthcare institutions on product functionality
• Helping HCPs improve efficiency in product use
• Patient education

The Guidelines appear to extend the scope of legitimate purposes for free placement of medical devices by deleting two of the items from this list, but also adding “and so forth (等)” to the end of the list, indicating that the list is illustrative, rather than restrictive.

The Guidelines are the clearest guidance to date on Chinese regulators’ views regarding life sciences industry practices. Companies operating in China would be well advised to ensure that their compliance programs meet the requirements set forth in the Guidelines. For questions on this or any other subject, please reach out to the authors or any of their colleagues in Arnold & Porter’s Life Sciences & Healthcare Regulatory or White Collar Defense & Investigations practice groups.

© Arnold & Porter Kaye Scholer LLP 2025 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.