适当考虑.....:关于会员国根据《HTA 条例》第 13 条所承担义务的几点思考

IF 0.6 Q2 LAW
Gisela Ernst, Karl Stöger
{"title":"适当考虑.....:关于会员国根据《HTA 条例》第 13 条所承担义务的几点思考","authors":"Gisela Ernst, Karl Stöger","doi":"10.1163/15718093-bja10122","DOIUrl":null,"url":null,"abstract":"<p>The new EU Regulation on health technology assessment (<span style=\"font-variant: small-caps;\">HTAR</span>) provides for joint clinical assessments (<span style=\"font-variant: small-caps;\">JCA</span>) of health technologies at EU level. When Member States carry out health technology assessments (<span style=\"font-variant: small-caps;\">HTA</span>) at the national level, they shall give due consideration to the results of a <span style=\"font-variant: small-caps;\">JCA</span> and comply with other obligations of the Regulation. This article aims to clarify what these obligations mean for the Member States and whether <span style=\"font-variant: small-caps;\">JCA</span> results have to be considered outside a national health technology assessment as well. In this context, the question of which processes qualify as ‘national <span style=\"font-variant: small-caps;\">HTA</span>’ and which requirements need to be fulfilled to trigger the obligations under Article 13 <span style=\"font-variant: small-caps;\">HTAR</span> are discussed in more detail in this paper.</p>","PeriodicalId":43934,"journal":{"name":"EUROPEAN JOURNAL OF HEALTH LAW","volume":"115 1","pages":""},"PeriodicalIF":0.6000,"publicationDate":"2024-03-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Give Due Consideration …: Some Thoughts on Member States’ Obligations Under Article 13 of the HTA Regulation\",\"authors\":\"Gisela Ernst, Karl Stöger\",\"doi\":\"10.1163/15718093-bja10122\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p>The new EU Regulation on health technology assessment (<span style=\\\"font-variant: small-caps;\\\">HTAR</span>) provides for joint clinical assessments (<span style=\\\"font-variant: small-caps;\\\">JCA</span>) of health technologies at EU level. When Member States carry out health technology assessments (<span style=\\\"font-variant: small-caps;\\\">HTA</span>) at the national level, they shall give due consideration to the results of a <span style=\\\"font-variant: small-caps;\\\">JCA</span> and comply with other obligations of the Regulation. This article aims to clarify what these obligations mean for the Member States and whether <span style=\\\"font-variant: small-caps;\\\">JCA</span> results have to be considered outside a national health technology assessment as well. In this context, the question of which processes qualify as ‘national <span style=\\\"font-variant: small-caps;\\\">HTA</span>’ and which requirements need to be fulfilled to trigger the obligations under Article 13 <span style=\\\"font-variant: small-caps;\\\">HTAR</span> are discussed in more detail in this paper.</p>\",\"PeriodicalId\":43934,\"journal\":{\"name\":\"EUROPEAN JOURNAL OF HEALTH LAW\",\"volume\":\"115 1\",\"pages\":\"\"},\"PeriodicalIF\":0.6000,\"publicationDate\":\"2024-03-13\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"EUROPEAN JOURNAL OF HEALTH LAW\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1163/15718093-bja10122\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"LAW\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"EUROPEAN JOURNAL OF HEALTH LAW","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1163/15718093-bja10122","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"LAW","Score":null,"Total":0}
引用次数: 0

摘要

欧盟关于卫生技术评估 (HTAR) 的新条例规定在欧盟层面对卫生技术进行联合临床评估 (JCA)。成员国在国家层面开展卫生技术评估 (HTA) 时,应适当考虑联合临床评估的结果,并遵守条例规定的其他义务。本文旨在阐明这些义务对成员国的意义,以及在国家卫生技术评估之外是否也必须考虑联合评估的结果。在此背景下,本文将更详细地讨论哪些程序符合 "国家卫生技术评估 "的条件,以及需要满足哪些要求才能触发《医疗卫生技术评估条例》第 13 条规定的义务。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Give Due Consideration …: Some Thoughts on Member States’ Obligations Under Article 13 of the HTA Regulation

The new EU Regulation on health technology assessment (HTAR) provides for joint clinical assessments (JCA) of health technologies at EU level. When Member States carry out health technology assessments (HTA) at the national level, they shall give due consideration to the results of a JCA and comply with other obligations of the Regulation. This article aims to clarify what these obligations mean for the Member States and whether JCA results have to be considered outside a national health technology assessment as well. In this context, the question of which processes qualify as ‘national HTA’ and which requirements need to be fulfilled to trigger the obligations under Article 13 HTAR are discussed in more detail in this paper.

求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
来源期刊
CiteScore
0.90
自引率
0.00%
发文量
52
期刊介绍: The European Journal of Jewish Studies (EJJS) is the Journal of the European Association for Jewish Studies (EAJS). Its main purpose is to publish high-quality research articles, essays and shorter contributions on all aspects of Jewish Studies. Submissions are all double blind peer-reviewed. Additionally, EJJS seeks to inform its readers on current developments in Jewish Studies: it carries comprehensive review-essays on specific topics, trends and debated questions, as well as regular book-reviews. A further section carries reports on conferences, symposia, and descriptions of research projects in every area of Jewish Studies.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术官方微信