摘要
药品行业关系公众健康福祉,其市场竞争秩序的良性发展对保障药品可及性和可负担性影响很大。专利药品与仿制药品存在共生与竞争的关系,专利药品相关市场的界定是整个反垄断案件得以顺利分析的重要一环,也影响着仿制药品市场可竞争的范围。然而,由于专利药品研发周期长、成本高,以及药品消费者、使用决策者和费用承担者三重主体不一致等特殊性,传统相关市场界定方法适用于专利药品领域面临诸多挑战。用途替代性方面,ATC分类标准面临范围过宽的困境;价格替代性方面,三重主体的不一致性影响着需求交叉弹性的分析;SSNIP方法层面又面临着数据难以获得的适用困境。为实现药品行业创新发展与药品可负担性提升之间的平衡,可以竞争损害为起点界定相关市场,并依据ATC3分类标准初步厘定用途替代性范围,通过多要素甄别药品之间的需求替代性,同时考虑非价格因素,慎用SSNIP方法。
The pharmaceutical industry is vital to public health and well-being,and the healthy development of its market competition order significantly impacts drug accessibility and affordability.Market definition related to pharmaceutical patents constitutes a critical component of antitrust enforcement.However,due to the unique characteristics of the industry—such as lengthy R&D cycles,high costs,and the tripartite separation of consumers,decision-makers,and payers—traditional relevant market definition methods face substantial challenges when applied to patent drug contexts.Functional substitution analysis,price substitution analysis,and the SSNIP(Small but Significant Non-transitory Increase in Price)test all exhibit limitations in delineating pharmaceutical relevant markets.To balance innovation incentives with improved drug affordability,a competition harm-oriented approach to relevant market definition is recommended.This framework could preliminarily identify functional substitution scopes based on the ATC3 classification system,assess demand substitution through multidimensional factors,incorporate non-price considerations,and apply the SSNIP method carefully.
作者
杨莉萍
Yang Liping(School of Law,Fuzhou University,Fuzhou 350101,China)
出处
《科技与法律(中英文)》
2025年第4期12-23,共12页
Science Technology and Law(Chinese-English Version)
基金
国家社会科学基金青年项目“药品专利领域反垄断规制研究”(20CFX052)。
关键词
专利药品
相关市场
ATC分类系统
非价格因素
patent drug
relevant market
Anatomical Therapeutic Chemical(ATC)Classification System
non-price factor
