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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
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
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