CCTV News: According to the official WeChat account of the Municipal Shuoxinyu, the State Administration for Market Regulation recently issued the "Compliance Guidelines for Pharmaceutical Enterprises to Prevent Commercial Bribery Risks" (hereinafter referred to as the "Guidelines").
The State Administration for Market Regulation conscientiously implements the decisions and deployments of the CPC Central Committee and the State Council, severely cracks down on illegal commercial bribery in the pharmaceutical field, and effectively safeguards the fair competition order in the pharmaceutical market and the lives, health and safety of the people. While strengthening supervision and law enforcement, the State Administration for Market Regulation also actively promotes the construction of a long-term mechanism for the governance of commercial bribery in the pharmaceutical field, and studies and formulates the "Guidelines" based on the operating characteristics of the pharmaceutical industry, providing specific, clear and operational guidance and reference for pharmaceutical companies to establish and improve compliance systems, and eradicate the soil for the breeding of commercial bribery from the source.
The "Guidelines" contains 4 chapters, a total of 49 items. The "General Principles" chapter provides a systematic explanation of the goal significance, basic principles, scope of application, term definitions, etc. of the "Guidelines"; the "Construction of a Compliance Management System for Preventing Commercial Bribery Risks in Pharmaceutical Enterprises" chapter advocates the management of pharmaceutical companies to improve compliance awareness, encourages the establishment of compliance management organizations, compliance systems, compliance operation mechanisms and pays attention to the construction of compliance culture; the "Identification and Prevention of Commercial Bribery Risks in Pharmaceutical Enterprises" chapter provides detailed guidance on behavioral norms and risk identification and prevention matters in nine concrete scenarios in the field of pharmaceutical purchase and sales; the "Disposal of Commercial Bribery Risks in Pharmaceutical Enterprises" chapter guides pharmaceutical companies to achieve effective risk control by improving internal control measures and cooperating with supervision and law enforcement.
The "Guidelines" are fully close to the actual situation of the pharmaceutical industry, and focus on concrete descriptions and practical guidance. A summary and sort out the commercial bribery risk points in nine specific scenarios, including academic visits and exchanges, business reception, consulting services, outsourcing services, discounts and commissions, donation sponsorship and funding, free delivery of medical equipment, clinical research, retail terminal sales, etc., covering the entire business process of the pharmaceutical purchase and sales field. The risk factors in each scenario are evaluated one by one, and a clear classification prompt is made according to the risk level, and two positive and negative reference "lists" are listed: the normative requirements for the business behavior of pharmaceutical companies are divided into four levels: "should, can, suggest, and advocate" for standardized prompts; the risks that pharmaceutical companies should identify and prevent are divided into three levels: "prohibited, avoided, and paid attention" according to the degree of illegal risks. On the basis of guiding pharmaceutical companies to accurately identify, evaluate and classify commercial bribery risks, a classified disposal plan for commercial bribery risks is proposed to guide enterprises to give full play to the main role and effectively improve the enthusiasm and effectiveness of compliance management.
The release of the "Guidelines" is an important measure to promote the transfer of post-law enforcement to pre-prevention at the medical field. It will further improve the effectiveness of commercial bribery governance in the medical field, continuously standardize and purify the market order of the pharmaceutical industry, and play an active role in creating a good industry environment with a clean and upright atmosphere.
