可获得性视角下韩国孤儿药供应保障体系研究及启示

Research on the supply guarantee system of orphan drugs in South Korea from the perspective of accessibility and its enlightenment

目的系统介绍韩国孤儿药的供应保障体系,为提高我国孤儿药可获得性提供参考。方法通过研究韩国孤儿药上市激励机制、储备供应机制和紧急使用机制,总结韩国孤儿药供应保障体系的基本特点和实践经验。并基于对我国孤儿药供应保障现状及现存问题的研究,提出提升我国孤儿药可获得性的具体建议。结果与结论韩国通过孤儿药认定渠道和配套激励政策,依托储备供应机制和紧急使用的进口途径,有效提高了孤儿药的可获得性。因此,建议我国从完善孤儿药认定和激励政策、增设孤儿药专职管理部门、优化临时进口途径3个方面,保障孤儿药的正常供应。

OBJECTIVE To systematically introduce the supply guarantee system of orphan drugs in South Korea,and to provide reference for improving the accessibility of orphan drugs in China.METHODS The basic characteristics and practical experience of supply guarantee system of orphan drugs in South Korea were summarized by studying the marketing incentive mechanism,reserve supply mechanism and emergency use mechanism.Then,based on the research on the current situation and existing problems of orphan drug supply in China,specific suggestions were put forward to improve the accessibility of orphan drugs in China.RESULTS&CONCLUSIONS South Korea has effectively improved the accessibility of orphan drugs through orphan drug identification channels and supporting incentive policies,relying on the reserve supply mechanism and the import route for emergency use.Therefore,it is suggested that China should guarantee the normal supply of orphan drugs from three aspects:improving the recognition and incentive policy of orphan drugs,building a full-time management department of orphan drugs,and optimizing the temporary import path.