中文摘要：

文章介绍分析了欧美国家及我国孤儿药立法的相关内容和现状,认为生物技术药物的发展有利于孤儿药的研发,并提出了孤儿药立法对生物技术药物研发的几点启示。

英文摘要：

This paper introduces and analyzes the related content and present situation of orphan drug legislation in European and American countries and China, argues that the development of biotechnology drugs is beneficial to R＆D of biotechnology drugs, and points out the enlightenment of orphan drug legislation on R＆D of biotechnology drugs.