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EUROPEAN JOURNAL OF HEALTH LAW最新文献

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EHDS and Free Movement of Patients: What EU Intervention is Needed? EHDS 和病人的自由流动：欧盟需要采取哪些干预措施？
IF 0.8
EUROPEAN JOURNAL OF HEALTH LAW Pub Date : 2024-04-13 DOI: 10.1163/15718093-bja10125
Johan van de Gronden, Marc Veenbrink
{"title":"EHDS and Free Movement of Patients: What EU Intervention is Needed?","authors":"Johan van de Gronden, Marc Veenbrink","doi":"10.1163/15718093-bja10125","DOIUrl":"https://doi.org/10.1163/15718093-bja10125","url":null,"abstract":"The European Commission issued a proposal for a Regulation on the European Health and Data Space to improve patient mobility. This <jats:sc>EHDS</jats:sc> Regulation lays down rules for the exchange of digital health data for primary use (treatment) and for secondary use (i.e. research, policymaking). This proposal has far-reaching implications for national healthcare systems. The question arises whether, with this draft, the Commission in fact proposes to overstep the powers of the European Union, as the delivery and organization of healthcare belongs to the competences of the Member States. Furthermore, the (lack of) exchange of digital health data is not the only hinderance for the free movement of patients. The current set-up of the Patient Directive and the Social Security Coordination Regulation also discourages patients from seeking treatment abroad. Therefore, a more integrated approach in the form of a new Patient Regulation is, in our view, needed.","PeriodicalId":43934,"journal":{"name":"EUROPEAN JOURNAL OF HEALTH LAW","volume":"51 1","pages":""},"PeriodicalIF":0.8,"publicationDate":"2024-04-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140596310","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 0.6
EUROPEAN JOURNAL OF HEALTH LAW Pub Date : 2024-04-01 DOI: 10.1163/15718093-12423563
Herman Nys
{"title":"European Court of Justice.","authors":"Herman Nys","doi":"10.1163/15718093-12423563","DOIUrl":"10.1163/15718093-12423563","url":null,"abstract":"","PeriodicalId":43934,"journal":{"name":"EUROPEAN JOURNAL OF HEALTH LAW","volume":" ","pages":"349-355"},"PeriodicalIF":0.6,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140872795","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 : 2024-03-22 DOI: 10.1163/15718093-bja10126
Joseph Dute, Tom Goffin
{"title":"European Court of Human Rights.","authors":"Joseph Dute, Tom Goffin","doi":"10.1163/15718093-bja10126","DOIUrl":"https://doi.org/10.1163/15718093-bja10126","url":null,"abstract":"","PeriodicalId":43934,"journal":{"name":"EUROPEAN JOURNAL OF HEALTH LAW","volume":"31 2","pages":"234-246"},"PeriodicalIF":0.8,"publicationDate":"2024-03-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140859067","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
Paving the Path for Sustainable and Responsible Off-Label Use of Pharmaceutical Products in Europe 为在欧洲可持续和负责任地使用标签外医药产品铺平道路
IF 0.8
EUROPEAN JOURNAL OF HEALTH LAW Pub Date : 2024-03-13 DOI: 10.1163/15718093-bja10123
Miquel Díaz Hernández, Waltter Roslin, Juli Mansnérus
{"title":"Paving the Path for Sustainable and Responsible Off-Label Use of Pharmaceutical Products in Europe","authors":"Miquel Díaz Hernández, Waltter Roslin, Juli Mansnérus","doi":"10.1163/15718093-bja10123","DOIUrl":"https://doi.org/10.1163/15718093-bja10123","url":null,"abstract":"Off-label use of pharmaceuticals involves a wide array of aspects ranging from legal and regulatory ones to clinical to safety considerations. Access to off-label therapies is particularly relevant question for patients in areas of unmet medical need. Simultaneously, off-label use also triggers wider considerations relating to social and economic sustainability of health care systems and access to health. National authorities have adapted different regulatory approaches to off-label use of pharmaceuticals, ranging from (1) “regulatory silence”; to (2) allowing off-label use at the discretion of the treating physician; and to (3) a more stringent approach in which off-label use is subject to third party approval. This article provides a brief overview of these different regulatory approaches from a helicopter perspective, and it discusses benefits and shortcomings these approaches. Finally, it presents ideas for preconditions for sustainable and responsible off-label use of pharmaceutical products to ensure patient safety whilst ensuring their timely access to health.","PeriodicalId":43934,"journal":{"name":"EUROPEAN JOURNAL OF HEALTH LAW","volume":"22 1","pages":""},"PeriodicalIF":0.8,"publicationDate":"2024-03-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140151786","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
Give Due Consideration …: Some Thoughts on Member States’ Obligations Under Article 13 of the HTA Regulation 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 0.8
EUROPEAN JOURNAL OF HEALTH LAW Pub Date : 2024-03-13 DOI: 10.1163/15718093-bja10122
Gisela Ernst, Karl Stöger
{"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":"https://doi.org/10.1163/15718093-bja10122","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":0.8,"publicationDate":"2024-03-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140106117","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 : 2024-02-06 DOI: 10.1163/15718093-bja10120
Joseph Dute, Tom Goffin
{"title":"European Court of Human Rights.","authors":"Joseph Dute, Tom Goffin","doi":"10.1163/15718093-bja10120","DOIUrl":"10.1163/15718093-bja10120","url":null,"abstract":"","PeriodicalId":43934,"journal":{"name":"EUROPEAN JOURNAL OF HEALTH LAW","volume":"31 1","pages":"122-127"},"PeriodicalIF":0.8,"publicationDate":"2024-02-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139913679","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 are the Changes in 2023 for Access to Advanced Therapy Medicinal Products (ATMPs) in France? 2023 年法国先进治疗药物 (ATMP) 的使用情况会发生哪些变化？
IF 0.8
EUROPEAN JOURNAL OF HEALTH LAW Pub Date : 2024-01-29 DOI: 10.1163/15718093-bja10121
Blanka Bartos
{"title":"What are the Changes in 2023 for Access to Advanced Therapy Medicinal Products (ATMPs) in France?","authors":"Blanka Bartos","doi":"10.1163/15718093-bja10121","DOIUrl":"10.1163/15718093-bja10121","url":null,"abstract":"<p><p>ATMPs are the most expensive innovative treatments, thus they require special regulation. Past regulatory measures in France, such as limiting the growth of drug expenditures, the creation of a fund to finance pharmaceutical innovation, the use of performance-based contracts and greater emphasis on medico-economic evaluations in pricing have been contributing to having both universal access to innovative therapies and fair remuneration for innovation. The importance of transparency, public participation in healthcare evaluation, and the challenges of setting drug prices based on their value are not negligible either. Although further negotiations are still necessary to ensure equitable access to medicines and control rising healthcare costs, France has made pioneering steps recently which would be worthy to follow for other states. The Social Security Financing Act for 2023 introduces measures to control face prices, offers a new funding model, and encourages manufacturers to submit reimbursement claims for the full scope of marketing authorizations.</p>","PeriodicalId":43934,"journal":{"name":"EUROPEAN JOURNAL OF HEALTH LAW","volume":" ","pages":"187-208"},"PeriodicalIF":0.8,"publicationDate":"2024-01-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139571665","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
Bringing Climate Change to Strasbourg. The Convention and Healthy Environment Claims. 将气候变化带到斯特拉斯堡。公约与健康环境诉求。
IF 0.8
EUROPEAN JOURNAL OF HEALTH LAW Pub Date : 2024-01-24 DOI: 10.1163/15718093-bja10119
André den Exter
{"title":"Bringing Climate Change to Strasbourg. The Convention and Healthy Environment Claims.","authors":"André den Exter","doi":"10.1163/15718093-bja10119","DOIUrl":"10.1163/15718093-bja10119","url":null,"abstract":"<p><p>Climate change profoundly impacts all aspects of human life, including health. International fora and nation States recognise the importance of urgently cutting greenhouse gas emissions as a primary cause of global warming. States' commitment to alter climate change has resulted in several treaty documents referring explicitly to human rights obligations. But what exactly are States' obligations under climate change treaty law and other human rights treaties? And what is the judiciary's role when confronted with the right to health violations and systemic deficiencies relating to climate change? Can climate change litigation give individual citizens a remedy to right to health violations and reduce the impact of climate change?</p>","PeriodicalId":43934,"journal":{"name":"EUROPEAN JOURNAL OF HEALTH LAW","volume":" ","pages":"153-170"},"PeriodicalIF":0.8,"publicationDate":"2024-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139565014","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
Critically-Ill Children and the International Human Rights System: Assessing the Status and Role of the UNCRPD in the Case of Archie Battersbee 重症儿童与国际人权体系：评估《联合国残疾人权利公约》在 Archie Battersbee 案件中的地位和作用
IF 0.8
EUROPEAN JOURNAL OF HEALTH LAW Pub Date : 2024-01-10 DOI: 10.1163/15718093-bja10118
Conrad Nyamutata
{"title":"Critically-Ill Children and the International Human Rights System: Assessing the Status and Role of the UNCRPD in the Case of Archie Battersbee","authors":"Conrad Nyamutata","doi":"10.1163/15718093-bja10118","DOIUrl":"https://doi.org/10.1163/15718093-bja10118","url":null,"abstract":"<p>Over the past few years, some parents and clinicians in the UK have argued about decisions on the fate of critically-ill children, with the cases ending in protracted and emotionally-sapping legal disputes. The long-running legal conflicts have played out in the public eye, eliciting conflicting opinions. At the core of the disputes is whether parents or clinicians should determine the appropriate course of action. In the event of the disagreements, the domestic court intervenes guided by the ‘best interests’ principle. A corpus of scholarship, falling on either side of the debate, has captured the contradictions. Until recently, the discourse had focused on the common recourses to domestic courts and the European Court of Human Rights. However, in the recent case of incapacitated 12-year-old Archie Battersbee, his parents sought redress from the international human rights system through the Committee on the Rights of People with Disabilities to stop termination of his life support. The courts barred the involvement of the Committee on the basis that the UK had not incorporated the treaty which birthed the Committee. The case brought into sharp focus the relationship between international law and domestic law. First, this paper asserts that the weight (not) given to international law by the domestic courts was inconsistent with its treatment of international obligations in other cases. Secondly, the position that unincorporated treaties do not have legal effect in domestic proceedings is ambiguous. Finally, the treaty body appeared ill-suited to handle a case of a critically-ill child in the face of the impatient demands of local justice.</p>","PeriodicalId":43934,"journal":{"name":"EUROPEAN JOURNAL OF HEALTH LAW","volume":"9 1","pages":""},"PeriodicalIF":0.8,"publicationDate":"2024-01-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139413585","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
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
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