Brief

"On December 20, 2023, the Market Supervision Administration released a new compliance guideline titled 《医药企业防范商业贿赂风险合规指引》 (_Guidance on Preventing Commercial Bribery Risks for Pharmaceutical Enterprises). The guideline aims to strengthen compliance in the pharmaceutical industry, specifically covering 9 scenarios of commercial bribery risks and providing guidance on risk identification, prevention, and mitigation. This new measure is expected to enhance regulatory efficiency and promote a clean and transparent market order."

据市说新语官微消息,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。

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Purpose
The Market Supervision Administration Bureau has released a set of guidelines, “Guidance on Preventing Commercial Bribery Risks in Pharmaceutical Enterprises” (hereinafter referred to as “Guide”), to help pharmaceutical enterprises establish a complete and compliant regulatory system. The purpose of the _Guide is to provide specific, clear, and operational guidance for pharmaceutical enterprises to prevent commercial bribery risks from the source.

Effects on Industry
The release of the Guide will have a significant impact on the pharmaceutical industry, promoting a shift in focus from post-enforcement supervision to pre-emptive prevention. The guidelines will strengthen the regulatory enforcement capabilities of the Market Supervision Administration Bureau while encouraging pharmaceutical enterprises to take a proactive role in preventing commercial bribery risks. This will lead to improved compliance management and risk control within the industry.

Relevant Stakeholders
The Guide affects various stakeholders, including:

  • Pharmaceutical companies: The guidelines provide clear guidance on establishing a compliant regulatory system, promoting a culture of compliance, and implementing measures to prevent commercial bribery risks.
  • Market Supervision Administration Bureau: The Guide provides a framework for the bureau to regulate pharmaceutical enterprises and ensure compliance with laws and regulations.
  • Consumers: The Guide aims to promote a fair and competitive market environment, ensuring that consumers have access to high-quality pharmaceutical products.

Next Steps
To comply with the Guide, pharmaceutical companies should:

  1. Establish a comprehensive regulatory system, including policies, procedures, and internal controls.
  2. Promote a culture of compliance within their organizations, emphasizing the importance of preventing commercial bribery risks.
  3. Implement measures to prevent commercial bribery risks, such as monitoring transactions and reporting suspicious activities.
  4. Cooperate with regulatory authorities in investigations and enforcement actions.

Any Other Relevant Information
The release of the Guide is an important step towards promoting a fair and competitive market environment in the pharmaceutical industry. The guidelines provide a clear framework for pharmaceutical companies to establish a compliant regulatory system, preventing commercial bribery risks and ensuring compliance with laws and regulations.

State Administration for Market Regulation (SAMR)

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