过期专利药超高定价反垄断规制框架  

Antitrust Regulatory Framework for Excessive Pricing of Off-patent Drugs

作　　者：杨莉萍 YANG Liping(Law School,Fuzhou University,Fuzhou Fujian 350100,China)

机构地区：[1]福州大学法学院,福建福州350001

出　　处：《法学论坛》2024年第5期141-149,共9页Legal Forum

基　　金：国家社科基金青年项目“药品专利领域反垄断规制研究”(20CFX052)的阶段性成果。

摘　　要：药品专利一旦过期,理应进入公有领域,然而为了防止利润下滑,药企常常借助于“去品牌化”和授权仿制的商业策略实施超高定价行为,严重降低公众药品可负担性,损害社会公共健康利益。在药品监管制度缺位的情况下,应当向反垄断法寻求规制框架。从《反垄断法》第二十二条出发,应当从市场支配地位的认定—“不公平高价”分析方法的适用—“不公平高价”的抗辩理由三个层面进行标准分析。在认定市场支配地位时,应当以市场份额作为初步认定标准,辅以原料药独家经销协议导致的合同障碍、因药品审批手续导致的规制障碍两个形式标准以及潜在竞争的及时性这一实质标准。在“不公平高价”分析方法适用时,应当将成本价格分析方法修正实施,以实际发生的成本作为基准判断价格,协同药品行业监管机构界定合理的利润率。在“不公平高价”的抗辩理由限缩时,排除竞争缺乏导致的消费者依赖以及药品专利尚未收回成本两个非价格因素。Once a drug patent expires,it should enter the public domain.But in order to prevent a decline in profits,pharmaceu-tical companies often resort to"de-branding"and licensed imitations as a commercial strategy to implement excessive pricing,seriously reducing the affordability of medicines for the public and undermining the interests of social public health.In the ab-sence of a regulatory system for drugs,a regulatory framework should be sought from the antitrust law.Starting from Article 22 of the Antimonopoly Act,three levels of analysis should be conducted,including the determination of market dominance,the appli-cation of the"unfairly high price"analysis,and the defense of"unfairly high price"for standard analysis.In determining market dominance,market share should be used as the initial criterion,supplemented by two formal criteria,namely,contractual barri-ers due to exclusive distribution agreements for APIs,regulatory barriers due to drug approval procedures,and the substantive criterion of timeliness of potential competition.When applying the"unfairly high price"analysis method,the cost-price analysis method should be revised and implemented,with the actual costs incurred as the basis for judging the price,and reasonable profit margins defined in cooperation with the regulatory body of the pharmaceutical industry.When the"unfairly high price"defense is narrowed,two non-price factors,consumer reliance due to lack of competition and the fact that the patent on the medicine has not yet recovered its costs,should be excluded.

关 键 词：过期专利药 超高定价 市场支配地位 成本—价格分析方法 

分 类 号：D922.294[政治法律—经济法学]