美国《孤儿药法案》的变迁及启示 ――基于对中国生物医药产业的研究
Institutional Change of Orphan Drug Act and Implications for China Based on Study of Chinese Biopharmaceutical Industry

运用制度理论和现象分析法，探讨了美国《孤儿药法案》形成以及颁布30余年的变迁，重点分析了其立法调整过程以及制度环境对生物医药产业发展的影响；认为其形成和变迁是一个三阶段的社会化过程，与产业组织结构相适应的制度环境能够有效促进产业发展；患者群体、联邦政府和制药企业分别在三个阶段中扮演主导角色，文化-认知性要素、规制性要素和规范性要素分别在三个阶段的变迁中起到推动作用；在结合中国实际的基础上，提出有效促进中国生物医药产业发展的核心是，既要紧抓制度环境建设，完善规制性要素，发挥其对产业发展的法律支柱作用，还要强化文化-认知性要素，夯实其积累基础并提前防范，关注规范性要素，以调控产业良性发展。
Formation and thirty-year institutional change of Orphan Drug Act are discussed using modern institutional theory and phenomenon analysis, with a specific focus on the legislation adjustments and the impact of institutional environment on industry development. Results show that institutional change of Orphan Drug Act is a three-stage societal process and appropriate institutional environments will significantly enhance biopharmaceutical industry development. Critical agents and institutional pillars are different across stages. Patients ,federal government, and enterprises are playing a dominant role in the three stages respectively. Cultural-cognitive, regulative, and normative pillars promote institutional change respectively. Finally, the implication for Chinese biopharmaceutical industry is to continue building appropriate institutional environments. Specifically, Chinese government is urged to improve the regulatory pillar to exert its legislative influence, to strengthen the cultural-cognitive pillar to accumulate more, and to reinforce the normative pillar to achieve benign progress