近日，市场监管总局发布《医药企业防范商业贿赂风险合规指引》（以下简称《指引》）。市场监管总局认真贯彻落实党中央、国务院决策部署，严厉打击医药领域商业贿赂违法行为，有力维护医药市场公平竞争秩序和人民群众生命健康安全。在加强监管执法的同时，市场监管总局还积极推进医药领域商业贿赂治理长效机制建设，根据医药行业经营特点研究制定《指引》，为医药企业建立健全合规体系提供具体、明晰、可操作的指导和参考，从源头上铲除商业贿赂滋生的土壤。《指引》包含4个章节，共49条。“总则”章节对《指引》的目标意义、基本原则、适用范围、术语定义等作出系统说明；“医药企业防范商业贿赂风险合规管理体系建设”章节倡导医药企业管理层提高合规意识，鼓励建立合规管理组织、合规制度、合规运行机制并注重合规文化建设；“医药企业商业贿赂风险识别与防范”章节对医药购销领域9个具象场景的行为规范和风险识别防范事项进行详细指导；“医药企业商业贿赂风险处置”章节指导医药企业通过完善内部管控措施、配合监管执法实现风险的有效管控。《指引》充分贴近医药行业实际，注重具象化描述和实操性指导。汇总梳理学术拜访交流、业务接待、咨询服务、外包服务、折扣折让及佣金、捐赠赞助和资助、医疗设备无偿投放、临床研究、零售终端销售等9个具体场景的商业贿赂风险点，覆盖医药购销领域全业务流程。对每个场景内的风险因素进行逐一评估，根据风险等级进行明确的分类提示，列出正面、负面两张参考“清单”：对于医药企业经营行为的规范要求，划分为“应当、可以、建议、倡导”四个档次进行规范提示；对于医药企业应予识别、防范的风险按照违法性风险程度，划分为“禁止、避免、关注”三个档次进行分类规制。在指导医药企业准确识别、评估、分级商业贿赂风险的基础上，提出对于商业贿赂风险的分类处置预案，引导企业充分发挥主体作用，切实提升合规管理的积极性和有效性。《指引》的发布是推动医药领域商业贿赂治理关口从事后执法向事前预防转移的重要举措，将进一步提升医药领域商业贿赂治理效能，持续规范和净化医药行业市场秩序，为营造风清气正的良好行业环境发挥积极作用。
Brief
"On January 14, 2025, the State Administration for Market Regulation released a compliance guideline for pharmaceutical enterprises to prevent commercial bribery risks. The document contains four chapters and 49 articles, providing specific guidance on risk management, identification, and mitigation in various scenarios such as business visits, consulting services, external outsourcing, discounts, donations, and clinical research."
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Purpose
The Market Regulation Bureau has released a “Guidance on Preventing Commercial Bribery Risks for Pharmaceutical Enterprises” to strengthen the regulation of commercial bribery in the pharmaceutical industry. This guidance aims to provide a clear and operational framework for pharmaceutical enterprises to establish a robust compliance system, ultimately eradicating the root causes of commercial bribery.
Effects on Industry
The release of this guidance marks a significant shift towards preventive measures in regulating commercial bribery in the pharmaceutical industry. By promoting a culture of compliance, encouraging the establishment of internal governance systems, and providing detailed guidelines for risk identification and mitigation, this guidance is expected to improve the overall efficiency of commercial bribery regulation in the industry. This will have a positive impact on the integrity of the market, ensuring fair competition and protecting consumers’ health and safety.
Relevant Stakeholders
Pharmaceutical enterprises, regulatory authorities, industry associations, and consumers are all stakeholders affected by this guidance. Pharmaceutical enterprises are required to establish a robust compliance system to prevent commercial bribery risks, while regulatory authorities will need to adapt their enforcement strategies to focus on preventive measures rather than solely reactive ones. Industry associations may also play a role in promoting the adoption of best practices and ensuring that members comply with these guidelines.
Next Steps
To comply with this guidance, pharmaceutical enterprises should take immediate action to:
- Enhance their compliance awareness and culture
- Establish internal governance systems and procedures to prevent commercial bribery risks
- Implement risk-based approaches for identifying and mitigating potential vulnerabilities
- Develop and maintain a robust compliance system that incorporates the guidelines outlined in this document
By following these steps, pharmaceutical enterprises can ensure they are adequately prepared to manage commercial bribery risks and comply with regulatory requirements.
Any Other Relevant Information
The release of this guidance marks an important milestone in the efforts to strengthen regulation and promote a healthy business environment in the pharmaceutical industry. By promoting preventive measures, encouraging compliance, and providing detailed guidelines for risk management, this document aims to create a culture of integrity and responsibility within the industry. The adoption of these guidelines will ultimately lead to improved market order, increased consumer trust, and a more favorable business climate.
