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Somatic Genome Editing with the Use of AI: Big Promises but Doubled Legal Issues. 使用人工智能进行体细胞基因组编辑:巨大的承诺，但双重法律问题。
IF 0.8
EUROPEAN JOURNAL OF HEALTH LAW Pub Date : 2022-04-08 DOI: 10.1163/15718093-bja10079
Anastasiya Kiseleva
{"title":"Somatic Genome Editing with the Use of AI: Big Promises but Doubled Legal Issues.","authors":"Anastasiya Kiseleva","doi":"10.1163/15718093-bja10079","DOIUrl":"https://doi.org/10.1163/15718093-bja10079","url":null,"abstract":"<p><p>Both Artificial Intelligence ('AI') and genome editing are technologies that on their own promise to revolutionise healthcare. But their common application can facilitate progress in the field even more. Multiplied benefits go along with increased risks. In this article, I identify and analyse legal challenges associated with applying AI facilities in medicinal products based on somatic genome editing. These challenges are caused by several factors. First, the two technologies share the characteristics that create and facilitate common risks. Second, each of the technologies is subject to very complex regulatory frameworks. These frameworks are not substantially connected to control the safety and quality of the common product. The main argument of this paper is that the management of common risks is only possible through common procedures. I discover the gaps in the current legislation that prevent from establishing these common procedures and provide recommendations to fill them in.</p>","PeriodicalId":43934,"journal":{"name":"EUROPEAN JOURNAL OF HEALTH LAW","volume":"29 3-5","pages":"381-408"},"PeriodicalIF":0.8,"publicationDate":"2022-04-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10022046","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
Genome Editing: Learning from Its Past and Envisioning Its Future. 基因组编辑:从过去学习，展望未来。
IF 0.8
EUROPEAN JOURNAL OF HEALTH LAW Pub Date : 2022-04-08 DOI: 10.1163/15718093-bja10081
Judit Sandor
{"title":"Genome Editing: Learning from Its Past and Envisioning Its Future.","authors":"Judit Sandor","doi":"10.1163/15718093-bja10081","DOIUrl":"https://doi.org/10.1163/15718093-bja10081","url":null,"abstract":"<p><p>With the technical possibility of genome editing, we have reached a new phase of transforming human beings and even altering our genetic legacy. Genome editing constitutes new responsibilities in many fields. Science and society have never been as dependent on each other as they are today. We must also learn from the past episodes of eugenics and we need to investigate fraudulent practices and cases of failure in scientific research that have often occurred due to merciless scientific competition, profit-seeking commercial interests, or individual pride. Genome editing raises numerous legal questions, such as: Would it be possible to make a legal difference between specific versions of gene editing? Who decides on what is considered a disease or an anomaly, a condition, or a variation? Which diseases are worth being corrected or treated and which ones are not? What kinds of social implications will gene editing bring about when it becomes widely available? Some normative distinctions have already been made in the case of gene therapy: separating somatic from germline interventions. But this distinction has not yet been analyzed in the light of the most recent editing practices. Genome editing also realigns the structure of ethical debates. It makes us rethink the concept of discrimination and scrutinize its cases in the field of assisted reproductive procedures. It revolutionizes the concept of medical treatment. It may increase or reduce inequalities based on health conditions. It may lead to numerous new rights in the field of genetics. Good genome editing practice can only be achieved through the close cooperation between the natural and social sciences. The present paper will endeavor to examine this new form of dialogue.</p>","PeriodicalId":43934,"journal":{"name":"EUROPEAN JOURNAL OF HEALTH LAW","volume":"29 3-5","pages":"341-358"},"PeriodicalIF":0.8,"publicationDate":"2022-04-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10016662","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
Transformation of Medical Care through Gene Therapy and Human Rights to Life and Health - Balancing Risks and Benefits. 通过基因治疗实现医疗保健的转变以及生命和健康的人权——平衡风险和收益。
IF 0.8
EUROPEAN JOURNAL OF HEALTH LAW Pub Date : 2022-04-05 DOI: 10.1163/15718093-bja10084
Anne Kjersti Befring
{"title":"Transformation of Medical Care through Gene Therapy and Human Rights to Life and Health - Balancing Risks and Benefits.","authors":"Anne Kjersti Befring","doi":"10.1163/15718093-bja10084","DOIUrl":"10.1163/15718093-bja10084","url":null,"abstract":"<p><p>This article is about how somatic gene therapy can be legally regulated and risk assessed as medical treatment when taking the following international human rights conventions into consideration: the right to life in Article 2 of the ECHR and the right to health in Article 12 of ICESCR. The right to life can involve both protection against risky genetic methods and access to necessary health care. In this context, human rights can be a basis for identifying interests that must be considered in a rapid technological development. Focusing mainly on human rights to life and to health, it is argued (1) against a total ban or general moratoriums on gene editing; (2) that regulations should be based on international cooperation and consensus; and that (3) rights to health may involve obligations to provide access to genetic methods.</p>","PeriodicalId":43934,"journal":{"name":"EUROPEAN JOURNAL OF HEALTH LAW","volume":"1 1","pages":"1-22"},"PeriodicalIF":0.8,"publicationDate":"2022-04-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41878548","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 : 2022-03-18 DOI: 10.1163/15718093-12423547
H. Nys
{"title":"European Court of Justice.","authors":"H. Nys","doi":"10.1163/15718093-12423547","DOIUrl":"https://doi.org/10.1163/15718093-12423547","url":null,"abstract":"","PeriodicalId":43934,"journal":{"name":"EUROPEAN JOURNAL OF HEALTH LAW","volume":"1 1","pages":"1-7"},"PeriodicalIF":0.8,"publicationDate":"2022-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42691421","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
Rabbit Endothelial Progenitor Cells Derived From Peripheral Blood and Bone Marrow: An Ultrastructural Comparative Study. 从外周血和骨髓中提取的兔内皮祖细胞：超微结构比较研究
IF 2.8
EUROPEAN JOURNAL OF HEALTH LAW Pub Date : 2022-03-17 DOI: 10.1017/S143192762200037X
Hana Duranova, Veronika Valkova, Lucia Olexikova, Barbora Radochova, Andrej Balazi, Peter Chrenek, Jaromir Vasicek
{"title":"Rabbit Endothelial Progenitor Cells Derived From Peripheral Blood and Bone Marrow: An Ultrastructural Comparative Study.","authors":"Hana Duranova, Veronika Valkova, Lucia Olexikova, Barbora Radochova, Andrej Balazi, Peter Chrenek, Jaromir Vasicek","doi":"10.1017/S143192762200037X","DOIUrl":"10.1017/S143192762200037X","url":null,"abstract":"<p><p>The present study was designed to compare the ultrastructure of early endothelial progenitor cells (EPCs) derived from rabbit peripheral blood (PB-EPCs) and bone marrow (BM-EPCs). After the cells had been isolated and cultivated up to passage 3, microphotographs obtained from transmission electron microscope were evaluated from qualitative and quantitative (unbiased stereological approaches) points of view. Our results revealed that both cell populations displayed almost identical ultrastructural characteristics represented by abundant cellular organelles dispersed in the cytoplasm. Moreover, the presence of very occasionally occurring mature endothelial-specific Weibel–Palade bodies (WPBs) confirmed their endothelial lineage origin. The more advanced stage of their differentiation was also demonstrated by the relatively low nucleus/cytoplasm (N/C) ratios (0.41 ± 0.19 in PB-EPCs; 0.37 ± 0.25 in BM-EPCs). Between PB-EPCs and BM-EPCs, no differences in proportions of cells occupied by nucleus (28.13 ± 8.97 versus 25.10 ± 11.48%), mitochondria (3.71 ± 1.33 versus 4.23 ± 1.00%), and lipid droplets (0.65 ± 1.01 versus 0.36 ± 0.40%), as well as in estimations of the organelles surface densities were found. The data provide the first quantitative evaluation of the organelles of interest in PB-EPCs and BM-EPCs, and they can serve as a research framework for understanding cellular function.</p>","PeriodicalId":43934,"journal":{"name":"EUROPEAN JOURNAL OF HEALTH LAW","volume":"11 1","pages":"1-11"},"PeriodicalIF":2.8,"publicationDate":"2022-03-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87109363","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 Multilevel Dimension of Rules-Based Disease Surveillance beyond the State. 超越国家的基于规则的疾病监测的多层次维度。
IF 0.8
EUROPEAN JOURNAL OF HEALTH LAW Pub Date : 2022-03-09 DOI: 10.1163/15718093-bja10070
Pedro A. Villarreal
{"title":"The Multilevel Dimension of Rules-Based Disease Surveillance beyond the State.","authors":"Pedro A. Villarreal","doi":"10.1163/15718093-bja10070","DOIUrl":"https://doi.org/10.1163/15718093-bja10070","url":null,"abstract":"The timely availability of accurate information on disease outbreaks with a potential for cross-border spread is a global public good, allowing for a more effective preparedness and response. An ensuing question for national public health authorities is how such information is attained when it is gathered in territories beyond their jurisdiction. International and regional law norms emerge as an option for providing such a global public good. Therefore, the current article examines existing legal frameworks for ad hoc disease surveillance beyond the state at the international and regional levels, namely: the World Health Organization's International Health Regulations of 2005; Regulation (EC) No. 851/2004 and Decision No. 1082/2013/EU in the European Union; the Statute of the Africa Centres for Disease Control and Prevention within the African Union; and the Protocol from the Economic Community of West African States, which created the West African Health Organisation. The comparison offers broader insights on the role of rules as a vehicle for securing prompt and reliable information of new and re-emerging communicable diseases, such as Covid-19.","PeriodicalId":43934,"journal":{"name":"EUROPEAN JOURNAL OF HEALTH LAW","volume":"29 1 1","pages":"7-32"},"PeriodicalIF":0.8,"publicationDate":"2022-03-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43382060","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
German State Aid for Covid-19 Medicinal Products: A Risk for Solidarity in the European Union. 德国对新冠肺炎医药产品的国家援助：欧盟团结的风险。
IF 0.8
EUROPEAN JOURNAL OF HEALTH LAW Pub Date : 2022-03-09 DOI: 10.1163/15718093-bja10061
Kristine Plank
{"title":"German State Aid for Covid-19 Medicinal Products: A Risk for Solidarity in the European Union.","authors":"Kristine Plank","doi":"10.1163/15718093-bja10061","DOIUrl":"https://doi.org/10.1163/15718093-bja10061","url":null,"abstract":"To respond to the need for a vaccine against and a treatment for Covid-19, the German Federal Government (German government) used various economic incentives to promote pharmaceutical and biotechnological (biotech) research and development (R&D) as well as manufacturing. More specifically, it decided to subsidise several German companies working in this field. Such domestic measures might, however, present a challenge to European state aid law. It is against this backdrop that this article discusses the compatibility of the payments made with the new 'crisis-born' European legal framework for state aid. Furthermore, the article offers some critical comments on the aid's effects on solidarity and cohesion in the European Union (EU) and the proposals put forward for expanding the EU's health policy competencies.","PeriodicalId":43934,"journal":{"name":"EUROPEAN JOURNAL OF HEALTH LAW","volume":"29 1 1","pages":"53-78"},"PeriodicalIF":0.8,"publicationDate":"2022-03-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"49081809","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: 2
The Fragmented Nature of Pandemic Decision-making: A Comparative and Multilevel Legal Analysis. 流行病决策的碎片性：比较和多层面的法律分析。
IF 0.8
EUROPEAN JOURNAL OF HEALTH LAW Pub Date : 2022-03-04 DOI: 10.1163/15718093-bja10072
Irene Domenici, Pedro A. Villarreal
{"title":"The Fragmented Nature of Pandemic Decision-making: A Comparative and Multilevel Legal Analysis.","authors":"Irene Domenici, Pedro A. Villarreal","doi":"10.1163/15718093-bja10072","DOIUrl":"https://doi.org/10.1163/15718093-bja10072","url":null,"abstract":"","PeriodicalId":43934,"journal":{"name":"EUROPEAN JOURNAL OF HEALTH LAW","volume":"29 1 1","pages":"1-5"},"PeriodicalIF":0.8,"publicationDate":"2022-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48067724","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
Symphony or Cacophony? Orchestrating Federal Mechanics toward Covid-19 Response in the United States and Germany. 交响乐还是仙人掌？协调美国和德国应对新冠肺炎的联邦机制。
IF 0.8
EUROPEAN JOURNAL OF HEALTH LAW Pub Date : 2022-03-04 DOI: 10.1163/15718093-bja10063
L. Tonti
{"title":"Symphony or Cacophony? Orchestrating Federal Mechanics toward Covid-19 Response in the United States and Germany.","authors":"L. Tonti","doi":"10.1163/15718093-bja10063","DOIUrl":"https://doi.org/10.1163/15718093-bja10063","url":null,"abstract":"Governance is a critical upstream tool in public health emergency preparedness, for it provides structure to emergency response. Pandemics, singular public health emergencies, pose challenges to inherently fragmented federal governance systems. Understanding and utilizing the facilitators of response embedded within the system is critical. In its examination of how contemporary federal systems addressed fragmentation in the face of the Covid-19 pandemic, this article uses two mitigation measures, community masking and vaccination administration to compare elements of federal system mechanics in the United States and Germany's respective pursuits of public health goals. With particular focus on federal-state power-sharing, it analyzes the division and application of federal-state authority, therein examining mechanisms of executive expediency, as well as the cooperation of multilevel actors. Comparing the jurisdictions identifies inter-federal coordination, availability of exigency mechanisms, and federal guidance as facilitators of public health goal achievement.","PeriodicalId":43934,"journal":{"name":"EUROPEAN JOURNAL OF HEALTH LAW","volume":"29 1 1","pages":"79-102"},"PeriodicalIF":0.8,"publicationDate":"2022-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44877163","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
COVID-19 Vaccination and Legal Preparedness: Lessons from Ireland. COVID-19疫苗接种和法律准备:来自爱尔兰的经验教训。
IF 0.8
EUROPEAN JOURNAL OF HEALTH LAW Pub Date : 2022-03-04 DOI: 10.1163/15718093-bja10064
M. Tumelty, M. Donnelly, A. Farrell, Clayton Ó Néill
{"title":"COVID-19 Vaccination and Legal Preparedness: Lessons from Ireland.","authors":"M. Tumelty, M. Donnelly, A. Farrell, Clayton Ó Néill","doi":"10.1163/15718093-bja10064","DOIUrl":"https://doi.org/10.1163/15718093-bja10064","url":null,"abstract":"Ireland has been a leader in the COVID-19 vaccine rollout in the EU, with almost 80% of the eligible population (aged over 5 years) fully vaccinated at the time of writing. The success of the vaccine rollout in this jurisdiction notwithstanding, the legal frameworks supporting the rollout had significant lacunas. Two aspects in particular highlighted a lack of legal preparedness: the inadequacy of the legal framework for consent and the absence of a vaccine injury redress scheme. This paper explores these components of the COVID-19 vaccine rollout through the lens of legal preparedness. Whilst most often discussed in the context of command and control measures such as social distancing requirements and regional lockdowns, this paper argues for an expanded understanding of what it means to be legally prepared, highlighting the importance of the preparedness of domestic legal frameworks.","PeriodicalId":43934,"journal":{"name":"EUROPEAN JOURNAL OF HEALTH LAW","volume":"1 1","pages":"1-20"},"PeriodicalIF":0.8,"publicationDate":"2022-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44040287","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: 2
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