{"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}
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.
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.