为有效预防和制止药品领域垄断行为，保护药品领域市场公平竞争，维护消费者利益和社会公共利益，根据《中华人民共和国反垄断法》等法律规定，国务院反垄断反不正当竞争委员会制定出台《关于药品领域的反垄断指南》（以下简称《指南》）。一、起草背景药品行业是国民经济的重要组成部分，关系人民群众切身利益。药品领域垄断行为影响药品保供稳价，损害市场公平竞争秩序和消费者利益，社会各方反映强烈。2021年，针对原料药领域垄断行为多发的情况，原国务院反垄断委员会制定发布《关于原料药领域的反垄断指南》，对规范原料药领域垄断行为发挥了重要作用。随着反垄断执法深入开展，包括原料药在内的药品领域垄断行为更加隐蔽、复杂。特别是由于药品领域产业链条长，涉及主体范围广，经营模式复杂，在原则适用反垄断一般分析框架的基础上，其垄断行为类型、表现和损害具有一定的特殊性，有必要结合该领域特点和经营者行为模式等，在吸收原料药指南基础上，制定覆盖全药品品种的反垄断专门指南，明确药品领域反垄断执法的基本原则，细化垄断行为分析思路和认定因素，为药品领域反垄断执法和经营者合规提供更为明确、清晰的指引，提升反垄断监管的科学性、针对性和有效性，促进药品领域规范、健康、创新发展。二、起草过程（一）开展重点难点问题研究。聚焦药品领域反垄断监管突出问题，深入总结药品领域反垄断监管执法经验，对多发频发的垄断行为类型、表现形式、违法特点等进行系统全面梳理，对药品领域垄断行为产生原因和规制措施开展深入研究，为《指南》起草提供有力支撑。（二）加强与行业监管部门沟通。与行业监管部门就《指南》内容积极开展沟通，多次研究药品产业链和经营活动特点，有针对性地细化分析思路和认定标准，使相关规则更加符合药品行业监管实际。（三）广泛听取各方意见。坚持开门立法原则，2024年8月，在市场监管总局官网公开征求社会公众意见，同时广泛征求政府部门、经营主体和专家学者意见，召开药品企业和协会座谈会，了解行业情况，听取相关意见，确保《指南》科学完备，更好支持和规范药品行业发展。（四）充分开展专家论证。先后多次组织反垄断法学和经济学专家、药品协会及行业专家、专业律师等进行研讨，扎实开展《指南》论证，充分凝聚各方共识。三、主要内容《指南》共7章55条，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等，主要内容如下：（一）明确药品领域反垄断监管执法总体原则。系统阐释《指南》目的、依据及相关概念，明确药品领域反垄断执法的基本原则，细化药品领域相关市场界定的特定因素，要求药品领域行业协会、药品经营者（包括互联网经营者）依法经营、加强自律，建立健全有效的反垄断合规管理制度。（二）细化药品领域垄断协议行为表现。一是列举药品领域典型横向、纵向垄断协议行为，明确反垄断执法机构认定原则和思路；二是归纳药品领域新型垄断协议行为表现，总结反向支付协议适用《反垄断法》规制的考虑因素；三是指明药品领域组织、提供实质性帮助达成垄断协议的主要方式及面临的法律责任；四是对垄断协议不予禁止、豁免等规定的适用条件进行细化，为经营者提供更为清晰的指引。（三）完善药品领域滥用市场支配地位行为认定规则。一是细化和补充认定药品经营者具有市场支配地位的考虑因素，包括经营者控制药品供应链的情况、交易相对人的制衡能力等；二是列举药品领域滥用市场支配地位的常见表现形式，特别是对层层加价不当推高药品价格、延迟或者停止药品供货获得不当竞争优势等行为进行明确规定；三是明确药品领域新型滥用市场支配地位行为表现，总结产品跳转行为适用《反垄断法》规制的考虑因素；四是针对药品领域多个经营者分工协作、相互配合实施滥用市场支配地位行为的，明确认定其作为当事主体的考虑因素。（四）深化药品经营者集中审查考虑分析因素。一是提出药品领域经营者集中审查的整体分析框架，明确药品领域部分经营者集中虽然未达申报标准但仍可能具有排除、限制竞争影响的，国务院反垄断执法机构可以要求经营者进行申报；二是列举药品领域经营者集中的常见类型及涉及知识产权的交易可能构成经营者集中的情形；三是细化药品领域经营者集中竞争分析的具体考虑因素，结合药品领域经营者集中特点列举了附加限制性条件的具体类型。（五）总结药品领域公平竞争审查重点和滥用行政权力排除、限制竞争特点。一是涉及药品领域经营主体经济活动的法律、行政法规、地方性法规、规章、规范性文件以及具体政策措施，应当按照有关规定进行公平竞争审查；二是对药品领域行政机关滥用行政权力限定交易、妨碍药品进入市场、限制药品自由流通、限制招投标等典型行为的表现形式进行逐条细化列举。（六）阐明药品领域垄断行为的法律责任适用。一是明确药品经营者违反《反垄断法》的法律责任适用，包括从轻或者减轻处罚、从重或者加重处罚的具体情形等。二是加强联合惩戒机制，对执法中发现的其他药品领域违法违纪问题线索，及时移交行业监管部门、公安机关、纪检监察机关等有关单位作出处理。四、主要特点《指南》立足我国药品领域发展现状和特点，着力规范药品领域垄断违法行为，引导药品经营者依法竞争、合规经营，有助于推动药品领域公平竞争和高质量发展。主要有以下四方面特点：（一）坚持系统观念，完善监管链条。《指南》覆盖中药、化学药和生物制品等全药品领域的生产、经营行为。同时，《指南》构建事前事中事后全链条监管体系，形成企业经营合规指引、反垄断审查和调查、规制行政机关垄断、违法违纪线索移送等系统性制度设计，提升反垄断监管的科学性、针对性和有效性。（二）突出问题导向，细化制度指引。《指南》全面总结反垄断监管执法经验，系统梳理分析药品领域典型反垄断案例，并吸纳药品领域新型专利和互联网平台垄断行为，进一步细化认定思路和考量因素，构建符合药品行业发展规律和特点的反垄断规则，积极回应社会关切。（三）坚持宽严相济，充分把握规律。《指南》一方面明确对药品领域垄断行为、不配合反垄断调查行为依法从严从重处罚，强化法律威慑。另一方面细化豁免制度、宽大制度的适用条件，并结合药品领域具体实践列举了不构成垄断行为的若干情形，设置“红绿灯”，明确行为界线，有效规范药品领域经营者行为。（四）加强多元共治，倡导合规建设。《指南》鼓励和支持药品经营者、药品领域行业协会加强合规建设，提升合规意识和能力，从源头预防垄断行为发生。同时，加强药品领域违法行为协同监管和联合惩戒，与行业监管部门、纪检监察机关等建立联动机制，提升监管效能，形成规制合力，筑牢维护药品领域市场公平竞争、行业健康发展的防线。
Brief
"On ", the "National Drug Administration" issued an update regarding "关于药品领域的反垄断指南》". The "《指南》》 is a comprehensive guide to prevent and stop monopolistic behaviors in the pharmaceutical sector, protect market fair competition, and safeguard consumer interests and social public benefits. It aims to promote fair competition and high-quality development in the pharmaceutical industry."
Highlights content goes here...
Purpose
The purpose of this update is to provide a detailed analysis of the “Guidelines on Preventing and Stopping Monopolistic Behaviors in the Pharmaceutical Field” (hereinafter referred to as “the Guidelines”) issued by the National Development and Reform Commission of China. The Guidelines aim to prevent and stop monopolistic behaviors in the pharmaceutical field, protect market competition, and safeguard consumers’ interests and social public interests.
Effects on Industry
The Guidelines are expected to have a significant impact on the pharmaceutical industry, affecting not only pharmaceutical manufacturers but also online platforms that sell pharmaceutical products. The Guidelines will regulate the behavior of online platforms, ensuring they comply with anti-monopoly laws when engaging in business activities related to pharmaceuticals.
The Guidelines’ effects on industry include:
- Regulation of Pharmaceutical Manufacturers: The Guidelines will regulate the behavior of pharmaceutical manufacturers, preventing them from engaging in monopolistic behaviors that could harm consumers.
- Online Platforms Regulation: Online platforms selling pharmaceutical products must comply with anti-monopoly laws when engaging in business activities related to pharmaceuticals.
- Prevention of Monopolistic Behaviors: The Guidelines aim to prevent and stop monopolistic behaviors in the pharmaceutical field, protecting market competition and safeguarding consumers’ interests.
Relevant Stakeholders
The stakeholders affected by these guidelines include:
- Pharmaceutical Manufacturers: The Guidelines will regulate the behavior of pharmaceutical manufacturers, preventing them from engaging in monopolistic behaviors that could harm consumers.
- Online Platforms: Online platforms selling pharmaceutical products must comply with anti-monopoly laws when engaging in business activities related to pharmaceuticals.
- Consumers: Consumers will benefit from the protection of market competition and the prevention of monopolistic behaviors in the pharmaceutical field.
Next Steps
To comply with these guidelines, stakeholders should:
- Review Current Practices: Review current practices and policies to ensure compliance with anti-monopoly laws and regulations.
- Update Business Models: Update business models to reflect the Guidelines’ requirements, ensuring a fair and competitive market environment.
- Establish Compliance Programs: Establish compliance programs to monitor and report any suspicious activities or behaviors that may violate anti-monopoly laws.
Any Other Relevant Information
Additional details regarding these guidelines include:
- Historical Context: These guidelines build on previous efforts to regulate monopolistic behaviors in the pharmaceutical field, demonstrating a commitment to protecting consumers’ interests.
- Future Actions: Future actions may involve further refining or updating the Guidelines based on emerging trends and regulatory changes.
- Industry Collaboration: Industry collaboration is expected to increase as stakeholders work together to ensure compliance with these guidelines.
