美国制药企业热衷研发罕见病药的原因分析

Cause analysis for pharmaceutical industries keen to research and development of orphan drugs in America

因罕见病药的特殊性,较少制药企业关注罕见病药的研发,但近年来跨国制药企业研发热情持续升温,促进了罕见病药的发展。本文从研发注册鼓励政策、上市激励制度和外部环境支持3个方面入手,分析美国制药企业热衷研发罕见病药的原因,以期为完善我国这一领域的政策或制度制定提供参考,从而激励我国制药企业积极研发,促进我国罕见病药发展。

Because of the particularity of rare diseases, few pharmaceutical industries focus on research and development of orphan drugs. However, the research and development of orphan drugs by multinational pharmaceutical industries continued to heat up in recent years, promoting the development of orphan drugs. This study analyzes the causes of pharmaceutical industries keen to research and development of orphan drugs in America from the perspectives of registration incentives, market incentive system, and external environmental support, in order to provide a reference for improving the policy or system of this field in our country, so as to inspire the pharmaceutical industries to actively participate in the research and development of orphan drugs.