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殊途同归:中美两国制药行业反垄断监管比较研究

Different routes the same destination: a comparative study of antitrust regulation for pharmaceutical industry in the United States and China.

作者信息

Weng Jie, Liu Nailiang

机构信息

Center for Competition Law and Policy, School of Law, Chongqing University, Chongqing, China.

出版信息

Front Pharmacol. 2025 Apr 17;16:1557876. doi: 10.3389/fphar.2025.1557876. eCollection 2025.

DOI:10.3389/fphar.2025.1557876
PMID:40313616
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12045029/
Abstract

As a commercial trade with a public nature, the pharmaceutical industry is related to the interests of many consumers. It is important for many countries to carry out antitrust regulations in this industry, but there are differences in regulatory paths and specific practices (terms such as "anti-monopoly" and "antitrust" are used interchangeably, this study uses "antitrust" to maintain consistency in terminology). A key characteristic of the United States system is that courts play a leading role in interpreting and applying abstract antitrust laws, whereas Chinese administrative enforcement agencies directly apply specifically identified antitrust provisions for uniform regulation. Despite differences, pharmaceutical antitrust regulations in both countries ultimately aim to protect consumer welfare. This study examines the timelines of pharmaceutical antitrust regulation, the fields of regulation, the types of monopoly behavior and behavioral performances in two countries, and further analyses the differences in the regulatory paths and means, as well as the similarities and differences in the effects of regulation, in comparison with the current state of pharmaceutical antitrust regulation in the United States and China. The analysis serves as a valuable reference for the future development of pharmaceutical antitrust regulation in China.

摘要

作为具有公共性质的商业贸易,制药行业关乎众多消费者的利益。对许多国家而言,在该行业实施反垄断监管很重要,但在监管路径和具体做法上存在差异(“反垄断”和“反托拉斯”等术语可互换使用,本研究使用“反托拉斯”以保持术语一致性)。美国体系的一个关键特征是法院在解释和适用抽象的反托拉斯法律方面发挥主导作用,而中国的行政执法机构则直接适用具体明确的反托拉斯条款进行统一监管。尽管存在差异,但两国的制药反托拉斯监管最终目标都是保护消费者福利。本研究考察了两国制药反托拉斯监管的时间线、监管领域、垄断行为类型及行为表现,并与美国和中国制药反托拉斯监管的现状相比较,进一步分析监管路径和手段的差异以及监管效果的异同。该分析为中国制药反托拉斯监管的未来发展提供了有价值的参考。

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本文引用的文献

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The geography of prescription pharmaceuticals supplied to the USA: levels, trends, and implications.供应给美国的处方药地理分布:水平、趋势及影响
J Law Biosci. 2021 Jan 29;8(1):lsaa085. doi: 10.1093/jlb/lsaa085. eCollection 2021 Jan-Jun.
2
Merger mania: mergers and acquisitions in the generic drug sector from 1995 to 2016.并购狂热:1995年至2016年仿制药领域的并购情况
Global Health. 2017 Aug 22;13(1):62. doi: 10.1186/s12992-017-0285-x.