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

YANG Yifan; XIE Jinping; WENG Tingting; YAN Liyu; SHAO Rong

doi:10.6039/j.issn.1001-0408.2023.09.01

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

更新时间：2025-09-23

- Research on the supply guarantee system of orphan drugs in South Korea from the perspective of accessibility and its enlightenment
- ZHONGGUO YAOFANG Vol. 34, Issue 9, Pages: 1025-1030(2023)
- 作者机构：
  
  中国药科大学国家药物政策与医药产业经济研究中心，南京　211198
- 作者简介：
- 基金信息：
- DOI：10.6039/j.issn.1001-0408.2023.09.01
  CLC： R95
- Received：09 November 2022，
  
  Revised：2023-03-23，
  
  Accepted：24 March 2023，
  
  Published：15 May 2023
- 稿件说明：
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杨伊凡,谢金平,翁婷婷,等.可获得性视角下韩国孤儿药供应保障体系研究及启示 [J].中国药房,2023,34(09):1025-1030.

YANG Yifan,XIE Jinping,WENG Tingting,et al.Research on the supply guarantee system of orphan drugs in South Korea from the perspective of accessibility and its enlightenment[J].ZHONGGUO YAOFANG,2023,34(09):1025-1030.
杨伊凡,谢金平,翁婷婷,等.可获得性视角下韩国孤儿药供应保障体系研究及启示 [J].中国药房,2023,34(09):1025-1030. DOI： 10.6039/j.issn.1001-0408.2023.09.01.

YANG Yifan,XIE Jinping,WENG Tingting,et al.Research on the supply guarantee system of orphan drugs in South Korea from the perspective of accessibility and its enlightenment[J].ZHONGGUO YAOFANG,2023,34(09):1025-1030. DOI： 10.6039/j.issn.1001-0408.2023.09.01.

摘要

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。

Abstract

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.

关键词

Keywords

references

陈敏，郎炳辰，张伶俐，等 . 我国进口孤儿药可及性的调查研究 [J ] . 中国药学杂志， 2017 ， 52 （ 8 ）： 702 - 705 .

谷景亮，鲁艳芹，张睿，等 . 实现我国罕见病药物可及策略研究 [J ] . 卫生软科学， 2013 ， 27 （ 6 ）： 325 - 327 .

吴佳，王高峰 . 孤儿药可及性问题的伦理审视 [J ] . 锦州医科大学学报（社会科学版）， 2020 ， 18 （ 2 ）： 11 - 14，18 .

Ministry of Food and Drug Safety . Orphan drug designation regulations（No.2018- 41 ）[EB/OL ] .（ 2018-06-01 ）[ 2022-03-05 ] . https：//impfood.mfds.go.kr/CFBDD02F02?active=00035&cntntsSn=285720&cntntsMngId1=00035 https://impfood.mfds.go.kr/CFBDD02F02?active=00035&cntntsSn=285720&cntntsMngId1=00035 .

Ministry of Health and Welfare . Rare disease management law [EB/OL ] .（ 2020-09-12 ）[ 2022-03-22 ] . https：//www.law.go.kr/LSW//lsLinkProc.do?lsNm=%ED%9D%AC%EA%B7%80%EC%A7%88%ED%99%98%EA%B4%80%EB%A6%AC%EB%B2%95&chrClsCd=010202&mode=20& ancYnChk=0# https://www.law.go.kr/LSW//lsLinkProc.do?lsNm=%ED%9D%AC%EA%B7%80%EC%A7%88%ED%99%98%EA%B4%80%EB%A6%AC%EB%B2%95&chrClsCd=010202&mode=20&ancYnChk=0# .

HYEONG G L ， EILEEN J S . Distribution and marketing of drugs in South Korea：overview [EB/OL ] .（ 2019-10-01 ）[ 2022-03-22 ] . https：//uk.practicallaw.thomsonreuters.com/6-618-5565?contextData=（sc.Default）&transitionType=Default&firstPage=true https://uk.practicallaw.thomsonreuters.com/6-618-5565?contextData=(sc.Default)&transitionType=Default&firstPage=true .

Organisation for Economic Co-operation and Development . R&D tax incentives：Korea [EB/OL ] .（ 2020-12-15 ）[ 2022-10-22 ] . https：//www.oecd.org/sti/rd-tax-stats-korea.pdf https://www.oecd.org/sti/rd-tax-stats-korea.pdf .

SON K B . Market exclusivity of the originator drugs in South Korea：a retrospective cohort study [J ] . Front Public Health ， 2021 ， 9 ： 654952 .

Ministry of Food and Drug Safety . 2021 drug approval report [EB/OL ] .（ 2022-06-30 ）[ 2022-10-22 ] . https：//www.mfds.go.kr/eng/brd/m_19/view.do?seq=70437 https://www.mfds.go.kr/eng/brd/m_19/view.do?seq=70437 .

Ministry of Food and Drug Safety . Ministry of Food and Drug Safety White Paper [EB/OL ] .（ 2021-08-20 ）[ 2022-10-22 ] . https：//www.mfds.go.kr/docviewer/skin/doc.html?fn=20210820051540953.pdf&rs=/docviewer/result/data0013/33414/2/202203 https://www.mfds.go.kr/docviewer/skin/doc.html?fn=20210820051540953.pdf&rs=/docviewer/result/data0013/33414/2/202203 .

CHO I ， HAN E . Drug lag and associated factors for approved drugs in Korea compared with the United States [J ] . Int J Environ Res Public Health ， 2022 ， 19 （ 5 ）： 2857 .

Knowledge Ecology International . Request for Unity Korea：gleevec price reduction [EB/OL ] .（ 2009-10-10 ）[ 2022-10-22 ] . https：//www.keionline.org/21061#：~：text=Korean%20civil%20society%20has%20asked%20KEI%20to%20disseminate https://www.keionline.org/21061#:~:text=Korean%20civil%20society%20has%20asked%20KEI%20to%20disseminate ，for%20trying%20to%20reduce%20the%20price%20a% 2014 % 25 .

UAEM Korea . Access to orphan drugs in South Korea ：blind spot of the Korean health system [EB/OL ] .（ 2021-06-30 ）[ 2022-10-22 ] . https：//docslib.org/doc/2118490/access-to-orphan-drugs-in-south-korea-blind-spot-of-the-korean-health-system https://docslib.org/doc/2118490/access-to-orphan-drugs-in-south-korea-blind-spot-of-the-korean-health-system .

The Korea Orphan and Essential Drug Center . Center supply drugs [EB/OL ] .[ 2022-10-22 ] . https：//www.kodc.or.kr/drugInfo?medcinCtgryCode=E https://www.kodc.or.kr/drugInfo?medcinCtgryCode=E .

赵苑旨，侯佳欣 . 50家医院将能用氯巴占 [N ] . 健康时报， 2022-07-08 （14）.

李禾 . 让罕见病患者有医、有药、有保障 [N ] . 科技日报， 2023-01-11 （8）.

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