In 2024, legislative improvement and intensification of enforcement are driving the optimisation of a compliant business environment. Relevant regulations and policies have been optimised pertaining to commercial bribery, corporate internal corruption, pharmaceutical procurement and sales, and medical insurance fund management, etc, with further clarification on the legal applicability and punishment standards for violations. With cross-departmental enforcement collaboration, initiatives such as industry irregularities rectification, unannounced inspection, and intensified internal reporting mechanism further enhanced regulatory effectiveness. Authorities maintain a continuous focus on comprehensive governance across the industry’s entirety and throughout its entire chain of operations, which provides clearer compliance guidelines, promotes market competition, and injects vitality into business environment.
2024年进一步聚焦关键领域,通过立法完善与执法深化,推动合规营商环境实现优化。在商业贿赂、企业内部腐败、医药购销和医保基金管理等领域,优化相关法规政策、明确违规行为的法律适用和处罚标准;相关执法行动精准发力,加强医疗监督跨部门执法联动工作,通过行业乱象整治活动、飞行检查高风险领域、强化内部举报机制等,进一步提升监管效能。其中,监管机构持续聚焦医药领域生产、供销和使用等重点环节,对医药行业全领域、全链条、全覆盖系统治理。该等措施不仅为企业提供了更明晰化的合规指引,还能促进市场竞争秩序规范化,为营商环境的有序发展注入活力。
To regulate market order and promote fair competition, the drafts of Anti-Monopoly Guidelines for the Pharmaceutical Sector and the Compliance Guidelines for Pharmaceutical Companies on Preventing Commercial Bribery Risks were issued by the market regulation authorities for public comments. The former provides clearer guidance for anti-monopoly enforcement and compliance by operators in the pharmaceutical industry by addressing prominent monopoly issues, elaborating on the manifestations of monopolistic conducts, enforcement principles, and criteria for determination. The latter, as the first set of nationwide compliance guidelines targeting the prevention of commercial bribery in the healthcare industry, offers practical guidance for the establishment of corporate compliance systems, as well as for identifying, preventing, and managing compliance risks related to commercial bribery.
为进一步规范市场秩序,营造诚实守信、公平竞争的市场环境,市场监督管理部门先后就药品领域反垄断指南和医药企业防范商业贿赂风险合规指引征求意见。前者针对药品领域突出垄断问题,进一步细化垄断行为在药品领域的行为表现、执法原则和认定标准、为药品领域反垄断执法和经营者合规提供更为明晰的指引;后者作为首个针对医疗行业防范商业贿赂的全国性合规指引,为企业合规体系建设,识别、预防、应对在商业贿赂方面的合规风险提供具有操作性的指导。
Furthermore, industry associations also respond to compliance regulatory requirements to promote the orderly development of digital healthcare by issuing compliance guidelines, which for the first time, provides guidance for interactions between pharmaceutical companies and patients/patient organisations within digital interaction scenarios, thereby offering valuable practical reference.
进一步的,行业协会积极响应合规监管要求,为推动数字医疗有序发展,发布了数字医疗合规分项指南,在数字化互动场景下,首次针对医药企业与患者及患者组织的互动提出行为指引,对企业业务开展具有现实参考价值。