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The Proposal for a Directive on Defective Products: A Game Changer for Innovative Medicinal Products 缺陷产品指令提案：改变创新医药产品的游戏规则
IF 0.8
EUROPEAN JOURNAL OF HEALTH LAW Pub Date : 2024-01-10 DOI: 10.1163/15718093-bja10117
Mathieu Guerriaud, Valérie Siranyan
{"title":"The Proposal for a Directive on Defective Products: A Game Changer for Innovative Medicinal Products","authors":"Mathieu Guerriaud, Valérie Siranyan","doi":"10.1163/15718093-bja10117","DOIUrl":"https://doi.org/10.1163/15718093-bja10117","url":null,"abstract":"<p>At the end of 2022, the European Commission published a proposal for a directive to revise the strict liability regime introduced in 1985. Although the main goal of this new proposal is to adapt the regulations to information technologies such as artificial intelligence, it has multiple impacts on other economic sectors, including the pharmaceutical market. Therefore, this proposal could change the deal in terms of liability in this specific market. Indeed, the proposal modifies the burden of proof, which can be quite challenging to establish in the case of adverse effects of medicinal products. It introduces a possible presumption of liability for a manufacturer who fails to communicate, to a court, the information they required, which might jeopardise the protection of trade secrets and commercial confidentiality. In addition, the proposal also extends the limitation period, and more importantly, it mandates the application of the ‘development risk defence.’</p>","PeriodicalId":43934,"journal":{"name":"EUROPEAN JOURNAL OF HEALTH LAW","volume":"33 1","pages":""},"PeriodicalIF":0.8,"publicationDate":"2024-01-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139413759","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Concept of Due Care in Medical Law in a Comparative Perspective 从比较角度看医疗法中的适当注意概念
IF 0.8
EUROPEAN JOURNAL OF HEALTH LAW Pub Date : 2023-12-11 DOI: 10.1163/15718093-bja10114
Witold Borysiak
{"title":"Concept of Due Care in Medical Law in a Comparative Perspective","authors":"Witold Borysiak","doi":"10.1163/15718093-bja10114","DOIUrl":"https://doi.org/10.1163/15718093-bja10114","url":null,"abstract":"<p>In many European legal systems, the provisions of medical legislative acts impose directly on healthcare professionals an obligation to act with due care. This imperative may be considered a basic principle of practising all medical professions, and even a generally accepted principle of medical law. Due care is the manner of conduct by medical professionals that meets the requirements contained in an objective and external standard of conduct created for each specific obligational relationship. Despite the differences between European legal systems, from a comparative perspective it is possible to notice similar factors taken into account when determining the standards of due care in medicine. This is because the conduct of medical professionals is largely determined by actual state of medical knowledge, medical standards and deontological codes relating to all medical professional activities. The aim of the article is to discuss in detail these issues in comparative perspective.</p>","PeriodicalId":43934,"journal":{"name":"EUROPEAN JOURNAL OF HEALTH LAW","volume":"14 1","pages":""},"PeriodicalIF":0.8,"publicationDate":"2023-12-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138631183","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
European Court of Human Rights. 欧洲人权法院。
IF 0.8
EUROPEAN JOURNAL OF HEALTH LAW Pub Date : 2023-12-07 DOI: 10.1163/15718093-bja10116
Joseph Dute, Tom Goffin
{"title":"European Court of Human Rights.","authors":"Joseph Dute, Tom Goffin","doi":"10.1163/15718093-bja10116","DOIUrl":"https://doi.org/10.1163/15718093-bja10116","url":null,"abstract":"","PeriodicalId":43934,"journal":{"name":"EUROPEAN JOURNAL OF HEALTH LAW","volume":"30 5","pages":"585-601"},"PeriodicalIF":0.8,"publicationDate":"2023-12-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138811135","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
European Court of Justice. 欧洲法院。
IF 0.8
EUROPEAN JOURNAL OF HEALTH LAW Pub Date : 2023-11-28 DOI: 10.1163/15718093-12423560
Herman Nys
{"title":"European Court of Justice.","authors":"Herman Nys","doi":"10.1163/15718093-12423560","DOIUrl":"10.1163/15718093-12423560","url":null,"abstract":"","PeriodicalId":43934,"journal":{"name":"EUROPEAN JOURNAL OF HEALTH LAW","volume":" ","pages":"111-121"},"PeriodicalIF":0.8,"publicationDate":"2023-11-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138452762","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
European Court of Justice. 欧洲法院。
IF 0.8
EUROPEAN JOURNAL OF HEALTH LAW Pub Date : 2023-11-22 DOI: 10.1163/15718093-12423559
An Baeyens
{"title":"European Court of Justice.","authors":"An Baeyens","doi":"10.1163/15718093-12423559","DOIUrl":"10.1163/15718093-12423559","url":null,"abstract":"","PeriodicalId":43934,"journal":{"name":"EUROPEAN JOURNAL OF HEALTH LAW","volume":" ","pages":"578-584"},"PeriodicalIF":0.8,"publicationDate":"2023-11-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138300295","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
European Court of Justice. 欧洲法院。
IF 0.8
EUROPEAN JOURNAL OF HEALTH LAW Pub Date : 2023-10-23 DOI: 10.1163/15718093-12423558
Herman Nys
{"title":"European Court of Justice.","authors":"Herman Nys","doi":"10.1163/15718093-12423558","DOIUrl":"https://doi.org/10.1163/15718093-12423558","url":null,"abstract":"","PeriodicalId":43934,"journal":{"name":"EUROPEAN JOURNAL OF HEALTH LAW","volume":"30 5","pages":"569-577"},"PeriodicalIF":0.8,"publicationDate":"2023-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138811143","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Moral Dilemmas of Surrogate Motherhood 代孕母亲的道德困境
EUROPEAN JOURNAL OF HEALTH LAW Pub Date : 2023-10-10 DOI: 10.1163/15718093-bja10115
Milena Kavarić, Rajka Djoković
{"title":"Moral Dilemmas of Surrogate Motherhood","authors":"Milena Kavarić, Rajka Djoković","doi":"10.1163/15718093-bja10115","DOIUrl":"https://doi.org/10.1163/15718093-bja10115","url":null,"abstract":"Abstract In the sphere of new modalities of creating offspring, one of the most controversial issues is related to surrogacy because it opens the space to unforeseeable ethical, legal, sociological and psychological world of dilemmas. Surrogacy is the process whereby a woman carries and gives birth to a baby for a couple who cannot conceive naturally and it has become increasingly popular worldwide. This reproductive method relativized the biological fact of birth and denied the central moment in identifying motherhood, expressed in the ancient Roman proverb that the mother of a child is the woman who gave birth to it. Surrogate motherhood changes the notion of motherhood as it separates the natural functions of a woman as a mother, or it separates the genetic from the gestational motherhood. In such a situation, the biological riddle is: Who is the real mother of the child: the one who gives the genetic material or the one who gives birth to it? The answer to this question opens many moral and ethical dilemmas in complex relationships: the surrogate mother, the couple-clients and the child. As the successful medical practice of giving birth to another undeniably exists in different countries of the world, the further fate of this method of reproduction will significantly depend on ethical justifications.","PeriodicalId":43934,"journal":{"name":"EUROPEAN JOURNAL OF HEALTH LAW","volume":"41 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136358390","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
What Healthcare Services Temporary Protection Entitles to Have? Navigating the European Social Charter. 医疗保健服务临时保护有哪些权利？驾驭欧洲社会宪章。
IF 0.8
EUROPEAN JOURNAL OF HEALTH LAW Pub Date : 2023-09-29 DOI: 10.1163/15718093-bja10112
Yana Litins'ka
{"title":"What Healthcare Services Temporary Protection Entitles to Have? Navigating the European Social Charter.","authors":"Yana Litins'ka","doi":"10.1163/15718093-bja10112","DOIUrl":"10.1163/15718093-bja10112","url":null,"abstract":"<p><p>Due to the war against Ukraine, the European Union Temporary Protection Directive, establishing a new migration status of temporary protection, was activated for the first time. The substance of the minimum requirement for providing healthcare services in the Directive appears unclear but is supposed to correspond to human rights standards. This article analyses the standards established in the European Social Charter (revised), recognising several health-related rights. The paper clarifies the material scope of health-related rights and analyses to what extent the Charter applies to persons enjoying temporary protection. The application of health-related rights in the Charter varies depending on citizenship, whether refugee status was additionally sought, and whether a person is seen as a resident or regular worker. The study indicates ambiguity in the position of this group and how the European Social Rights Committee may include it in the scope of protection.</p>","PeriodicalId":43934,"journal":{"name":"EUROPEAN JOURNAL OF HEALTH LAW","volume":" ","pages":"51-72"},"PeriodicalIF":0.8,"publicationDate":"2023-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41161507","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Exploring Regulatory Interplay in the Health Internet of Everything: Digital Health Technologies, Data Protection and Cybersecurity. 探索万物健康互联网中的监管相互作用：数字健康技术、数据保护和网络安全。
IF 0.8
EUROPEAN JOURNAL OF HEALTH LAW Pub Date : 2023-07-25 DOI: 10.1163/15718093-bja10110
Aiste Gerybaite
{"title":"Exploring Regulatory Interplay in the Health Internet of Everything: Digital Health Technologies, Data Protection and Cybersecurity.","authors":"Aiste Gerybaite","doi":"10.1163/15718093-bja10110","DOIUrl":"10.1163/15718093-bja10110","url":null,"abstract":"<p><p>Against the backdrop of interconnected devices, people, and processes in the Internet of Everything (IoE) an examination of the MDR (Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EE), data protection and cybersecurity rules are carried out with respect to medical devices' privacy and security. The legal analysis therefore investigates how and to what extent the MDR could cope with the copious challenges of cybersecurity and data protection in the IoE of medical devices. The article sheds light on how the MDR sets a minimal standard of requirements for medical device safety and security. In this respect, an unexpected and complicated regulatory interplay is discussed providing for a well-coordinated approach for digital health technologies. Finally, the article discusses several key points of the proposed EU AI Regulation considering digital health technologies.</p>","PeriodicalId":43934,"journal":{"name":"EUROPEAN JOURNAL OF HEALTH LAW","volume":" ","pages":"533-549"},"PeriodicalIF":0.8,"publicationDate":"2023-07-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10006797","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
What Kind of Death? The Ethics of Determining One's Own Death, written by Govert den Hartogh. 什么样的死亡？决定自己死亡的伦理学》，作者：Govert den Hartogh。
IF 0.8
EUROPEAN JOURNAL OF HEALTH LAW Pub Date : 2023-06-30 DOI: 10.1163/15718093-12423557
Paul Schotsmans
{"title":"What Kind of Death? The Ethics of Determining One's Own Death, written by Govert den Hartogh.","authors":"Paul Schotsmans","doi":"10.1163/15718093-12423557","DOIUrl":"10.1163/15718093-12423557","url":null,"abstract":"","PeriodicalId":43934,"journal":{"name":"EUROPEAN JOURNAL OF HEALTH LAW","volume":" ","pages":"603-607"},"PeriodicalIF":0.8,"publicationDate":"2023-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10006798","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 1
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