Monopoly agreements for active pharmaceutical ingredients (API) occur from time to time. In the first half of 2025, The Supreme People's Court of the People’s Republic of China and Administration for Market Regulation have disclosed two cases of horizontal monopoly agreements in the API sector. Among them, the CP camphor case resulted in penalties and multiple remedial measures, offering valuable insights. The API market has become a hotbed for monopoly agreements due to the low cost and ease of maintaining such agreements among API operators, coupled with the broad profit margins available to the parties involved. The essential elements of an API monopoly agreement encompass subject element, form element, and effect element. The subject element should be defined primarily through demand substitution analysis. The form element should be assessed by examining the operators' collusive intent and shifts in competitive advantage. The effect element analysis should emphasize the operators' market share and API market price. With the deepening of anti-monopoly enforcement in the field of API, it is necessary to improve the anti-monopoly regulatory system of API by increasing the enforcement efforts, enhancing the precision of law enforcement and promoting the whole-chain supervision, optimize the regulatory system of the API industry in terms of streamlining the overall approval process and strengthening the bargaining power of downstream preparation enterprises, and implement a fair competition review system in this area, with a view to effectively enhancing the quality and effectiveness of the regulation of monopoly agreements on API.
Key words
API /
monopoly agreements /
CP camphor monopoly case /
anti-monopoly regulation /
drug regulation
{{custom_sec.title}}
{{custom_sec.title}}
{{custom_sec.content}}
References
[1] 许光耀. “经济学证据”与协同行为的考察因素[J].竞争政策研究,2015(1):92-93.
[2] 王晓晔. 反垄断法[M].北京:法律出版社,2011:9.
[3] 谢涛,马迎花,宋国旗,等.原料药市场垄断的成因与治理策略[J].中国医疗保险,2025(6):92-93.
[4] 时建中,童安肖图.原料药“独家经销”模式的垄断责任主体认定[J].海南大学学报(人文社会科学版),2021(2):73-75.
[5] 侯利阳. 共同市场支配地位法律分析框架的建构[J].法学,2018(4):147-148.
[6] 张泰安. 原料药行业垄断的产生机制与《反垄断法》规制路径[J].西部法学评论,2021(5):2.
[7] 刁萃. 44.39万罚单:小石子激起原料药反垄断大涟漪[J].中国价格监管与反垄断,2017(8):64.
[8] 许光耀. 垄断协议的反垄断法调整[M].北京:人民出版社,2018:44.
[9] 叶卫平. 价格垄断协议的认定及其疑难问题[J].价格理论与实践,2011(10):22.
[10] 孙晋,李胜利.竞争法原论[M].北京:法律出版社,2020:56-57.
[11] 孙晋,仝汉.从葡萄糖酸钙原料药垄断案管窥“单一经济体”的认定——揭开“企业集团”垄断的面纱[J].中国价格监管与反垄断,2020(9):33.
[12] 王健. 垄断协议认定与排除、限制竞争的关系研究[J].法学,2014(3):38-40.
[13] 兰磊. 论横向垄断协议与纵向垄断协议的区分——评上海日进电气诉松下电器等垄断纠纷案[J].上海交通大学学报(哲学社会科学版),2018(2):68.
[14] 王晓晔. 论相关市场界定在滥用行为案件中的地位和作用[J].现代法学,2018(3):63.
[15] 理查德·A·波斯纳.反托拉斯法[M].孙秋宁,译.北京:中国政法大学出版社,2003:92-108.
[16] 刘继峰. 俄罗斯反垄断法“协同行为”认定标准的创新及借鉴[J].法商研究,2011(3):112-119.
[17] BANERJEER A.A simple model of herd behavior[J]. Quarterly journal of economics, 1992, 107(3): 797-817.
[18] 方军雄. 企业投资决策趋同:羊群效应抑或“潮涌现象”?[J].财经研究,2012(11):92-93.
[19] 王佳,袁利佳.原料药、药用辅料和药包材登记和关联审评管理工作现状及优化建议[J].中国临床药理学杂志,2021(12):3398.
[20] 林逸玲,杨莉萍.原料药行业滥用市场支配地位行为反垄断规制及其改进[J].南京中医药大学学报(社会科学版),2023(4):242,245.
[21] 郑鹏程. 论拒绝交易反垄断规制的立法完善——以原料药反垄断执法为切入点[J].现代法学,2021(5):160.
[22] 钟洲,王麒植,阮睿,等.上游垄断与市场化改革的“供给悖论”——基于全面取消药品价格管制的研究[J].管理世界,2024(10):83.
[23] 李剑. 横向垄断协议法律适用的误读与澄清——评“深圳有害生物防治协会垄断案”[J].法学,2014(3):139-141.
[24] 王晓晔. 转售价格维持的反垄断规制适用“合理原则”之批判[J].法商研究,2021(1):42-47.
[25] EASTERBROOK H F.The limits of antitrust[J]. Texas law review, 1984, 63(1): 75-98.
[26] 林平. 论反垄断科学监管:决策理论分析及政策启示[J].中国工业经济,2022(4):21.
[27] 陈秀山. 现代竞争理论与竞争政策[M].北京:商务印书馆,1997:52-91.
[28] 赫伯特·霍温坎普.联邦反托拉斯政策:竞争法律及其实践[M].许光耀,江山,王展,译.北京:法律出版社,2009:3.
[29] 叶卫平. 反垄断法分析模式的中国选择[J].中国社会科学,2017(3):96-115.
[30] 兰磊. 论我国垄断协议规制的双层平衡模式[J].清华法学,2017(5):164-189.
[31] 孙晋. 数字平台的反垄断监管[J].中国社会科学,2021(5):123.
[32] 唐要家,唐春晖.数字平台垄断势力与反垄断事前监管[J].中国流通经济,2022(8):64-65.
[33] 孙晋,马姗姗.激励相容视角下公平竞争审查制度实施机制的优化[J].湖北社会科学,2024(5):118.
[34] 卢超. “一业一证”改革的许可创新与法治回应[J].中国法学,2025(4):127-145.
[35] 叶兴福. 关联审评审批制度改革背景下原料药企业面临的新机遇、新挑战与对策研究[J].中国食品药品监管,2019(3):58-60.
[36] 陈超,刘爱,张景辰.省级药品监管部门原料药注册监管的思考[J].中国食品药品监管,2023(6):91-93.
[37] 王晓晔. 关于公平竞争审查制度的若干思考[J].经济法论丛,2017(1):77-81.
[38] 阿力木江•阿布都克尤木,刘嘉豪,孙懿纲.我国药品采购领域公平竞争审查制度虚置问题检视[J].竞争政策研究,2024(4):23-39.
[39] 殷继国. 我国公平竞争审查模式的反思及其重构[J].政治与法律,2020(7):123-136.
[40] 殷继国. 我国公平竞争审查标准的理论阐释与规范再造[J].比较法研究,2023(5):110-115.
[41] 刘健,孙晋.公平竞争审查标准的困境检视与纾解路径——兼评海南公平竞争审查工作指引[J].民声,2025,(09):39-43.
[42] 李世杰,李伟.产业链纵向价格形成机制与中间产品市场垄断机理研究——兼论原料药市场的垄断成因及反垄断规制[J].管理世界,2019(12):70-85.
[43] 宋亚辉. 网络市场规制的三种模式及其适用原理[J].法学,2018(10):83.
