罕见病防治药械研发激励法律保障机制研究

Abstract
Figure/Table
References
Related Citation (3)

Download: PDF (1045 KB) HTML (1 KB)
Export: BibTeX | EndNote (RIS)

Abstract Orphan drugs and medical devices are related to people's lives and health.How to incentivize enterprises to increase R&D investment and ensure the safety,effectiveness,and accessibility of the products is an important issue faced in comprehensively promoting the construction of a healthy China.China has accumulated beneficial experience in implementing R&D incentive through legislation,but there are problems such as single incentive measures,lack of key systems,imbalance in incentive fields,lack of specialized legislation,policies need to be legalized,conflicts between norms.From the perspectives of protecting the rights and interests of patients,implementing constitutional provisions,and strengthening institutional construction,we should improve the availability of the products through institutional innovation and synergy on the track of the rule of law.In terms of the construction of the legal protection mechanism for R&D incentive of orphan drugs and medical devices,the ideas of equal emphasis on responsive and forward-looking legislation,equal emphasis on R&D incentive and full lifecycle supervision and so on should be adhered to.The R&D incentive legislation should be integrated into general laws and special laws,and the lower-level laws should be enacted around regulatory processes.The focus of institutional construction which framed the substantive content of legislation should be clarified based on the goal of saving R&D costs before registration,accelerating the process during registration,and improving R&D returns after registration.

Key words： Rare disease Orphan drug and medical device R&D incentive Legal protection mechanism

Received: 07 June 2023

PACS:

R951

	Service

	E-mail this article
	Add to my bookshelf
	Add to citation manager
	E-mail Alert
	RSS
	Articles by authors
	Xu Yingling
	Yang Yue

Cite this article:

Xu Yingling,Yang Yue. On the Legal Protection Mechanism for Research and Development Incentive of Orphan Drugs and Medical Devices[J]. , 2024, 5(2): 118-125.

URL:

http://www.zgkjlt.org.cn/EN/ OR http://www.zgkjlt.org.cn/EN/Y2024/V5/I2/118

[1]韩朦,高子雯,兰娅菲,等.罕见病及其药物相关政策的文本挖掘与量化分析[J].中国新药杂志,2022,31 (22):2193.
[2]王梦之,邹志,宋华琳.罕见病防治法律制度的现况与立法趋向[J].中国新药与临床杂志,2023,42 (2):71-72.
[3]丁志琛,韦冠,丁锦希.日本罕用药制度及其对中国的启示:基于对日本罕用药可及性的评价[J].中国药科大学学报,2014,45 (1):123.
[4]李壮琪,杨浦,杨悦.基于Orphadata数据库的中国罕见病界定及累积时点患病率测算[J].中国新药杂志,2022,31 (24):2427.
[5]翁婷婷,谢金平,闫丽羽,等.美国和欧盟孤儿药认定标准的比较及启示[J].中国卫生政策研究,2023,16 (1):74.
[6]王雪,赵聪,许淑红,等.我国罕见病用药可及性现状分析[J].中国临床药理学杂志,2021,37 (8):1028-1031.
[7]焦海涛.罕见病药品供应中的市场独占权及其法律限制[J].东方法学,2022 (5):153.
[8]丁瑨.罕用药政策对生物医药产业的影响:基于美国生物科技公司的案例研究[J].中国科技论坛,2014 (11):95-96.
[9]WESTERMARK K,HOLM B B,SÖDERHOLM M,et al.European regulation on orphan medicinal products:10 years of experience and future perspectives[J].Nature reviews drug discovery,2011,10 (5):349.
[10]FDA.FDA approves first subcutaneous C1 esterase inhibitor to treat rare genetic disease[EB/OL]. (2017-06-22)[2023-07-18].https://www.fda.gov/news-events/press-announcements/fda-approves-first-subcutaneous-c1-esterase-inhibitor-treat-rare-genetic-disease.
[11]门中敬,李瑾.规章的“法源”地位:制度变迁、理论推演与现实关照[J].行政法学研究,2023 (2):120.
[12]雷磊.新科技时代的法学基本范畴:挑战与回应[J].中国法学,2023 (1):81.
[13]eCFR.21 U.S.C.§ 360cc[EB/OL]. (2023-05-03)[2023-07-18].https://www.ecfr.gov/current/title-21/chapter-I/subchapter-D/part-316.
[14]EC.Regulation (EC)No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products[EB/OL]. (2019-07-26)[2023-07-18].https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32000R-0141&qid=1675536514087.
[15]国会.医薬品、医療機器等の品質、有効性及び安全性の確保等に関する法律[EB/OL]. (2015-06-26)[2023-07-18].https://www.japaneselawtranslation.go.jp/en/laws/view/3213#je_ch4at9.
[16]DOOMS M M.Orphan devices:yesterday is history;tomorrow is mystery:towards a European orphan device directive[J].Orphanet journal of rare diseases,2016,11 (1):3.
[17]GAMMIE T,LU C Y,BABAR Z U.Access to orphan drugs:a comprehensive review of legislations,regulations and policies in 35 countries[J].Plos one,2015,10 (10):19.
[18]刘银良,吴柯苇.创新型国家导向的中国科技立法与政策:理念与体系[J].科技导报,2021,39 (21):46.
[19]宋华琳,范乾帅,任肖容,等.药物创新立法比较研究[M].南京:译林出版社,2023.
[20]汉斯·凯尔森.法与国家的一般理论[M].沈宗灵,译.北京:商务印书馆,2013.
[21]张翔.宪法与部门法的三重关系[J].中国法律评论,2019 (1):27.
[22]练育强.上海市罕见疾病立法相关问题研究[M]//中国科协学会学术部.我国罕见疾病研究关键问题与对策.北京:中国科学技术出版社,2012.
[23]罗豪才,宋功德.认真对待软法:公域软法的一般理论及其中国实践[J].中国法学,2006 (2):3.
[24]周佑勇.中国行政基本法典的精神气质[J].政法论坛,2022,40 (3):64.
[25]杨登峰.我国试验立法的本位回归:以试行法和暂行法为考察对象[J].法商研究,2017,34 (6):31.
[26]王灿发.论生态文明建设法律保障体系的构建[J].中国法学,2014 (3):49.