{"title":"The Conceptual Legal Structure of The Patient's Right to Informed Consent.","authors":"Noelia Martínez-Doallo","doi":"10.1163/15718093-bja10087","DOIUrl":"10.1163/15718093-bja10087","url":null,"abstract":"<p><p>Informed consent has been inconsistently conceptualised as a right, an immunity or even a power in the hands of the patient, which leaves its legal definition as partially indefinite. From the norms of the CHRB, a legal theory stance and the proposals of celebrated authors - namely, W.N. Hohfeld, H. Kelsen and R. Alexy, I will provide a steady conceptual structure for the subjective legal positions of the parties involved in the healthcare relationship regarding informed consent.</p>","PeriodicalId":43934,"journal":{"name":"EUROPEAN JOURNAL OF HEALTH LAW","volume":"1 1","pages":"1-24"},"PeriodicalIF":0.8,"publicationDate":"2022-05-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42588127","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}
{"title":"Women's Birthing Bodies and the Law: Unauthorised Intimate Examinations, Power and Vulnerability, edited by Camilla Pickles and John Herring.","authors":"Emma Milne","doi":"10.1163/15718093-bja10088","DOIUrl":"10.1163/15718093-bja10088","url":null,"abstract":"","PeriodicalId":43934,"journal":{"name":"EUROPEAN JOURNAL OF HEALTH LAW","volume":"1 1","pages":"1-2"},"PeriodicalIF":0.8,"publicationDate":"2022-05-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43741970","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}
{"title":"European Court of Justice.","authors":"A. Baeyens","doi":"10.1163/15718093-12423548","DOIUrl":"https://doi.org/10.1163/15718093-12423548","url":null,"abstract":"","PeriodicalId":43934,"journal":{"name":"EUROPEAN JOURNAL OF HEALTH LAW","volume":"29 2 1","pages":"314-320"},"PeriodicalIF":0.8,"publicationDate":"2022-04-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48848704","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}
{"title":"The European Court of Human Rights and the Emergence of Human Germline Genome Editing.","authors":"Merel M Spaander","doi":"10.1163/15718093-bja10082","DOIUrl":"https://doi.org/10.1163/15718093-bja10082","url":null,"abstract":"<p><p>The field of human germline genome editing (HGGE) offers a promising reproductive potential to prevent inheritance of genetic diseases, yet also opens the door to undesirable eugenics. This stirred the debate about the acceptability of HGGE in light of human rights, particularly human dignity. The European Convention of Human Rights (ECHR) and the European Court of Human Rights (ECtHR) use human dignity as a guiding principle. Therefore, this article examined the clinical implementation of HGGE in light of relevant case-law regarding Article 2 and Article 8 ECHR. The analysis illustrates that the ECtHR broadens the scope of artificial reproductive rights under Article 8, however, Contracting States of the Council of Europe can limit these rights and the accessibility to reproductive techniques, such as HGGE. The ECtHR remains elusive about the legal status of unborn life, but protection under Article 2 with the introduction of HGGE should not be ruled out.</p>","PeriodicalId":43934,"journal":{"name":"EUROPEAN JOURNAL OF HEALTH LAW","volume":"29 3-5","pages":"458-483"},"PeriodicalIF":0.8,"publicationDate":"2022-04-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10019381","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}
{"title":"Governing, Protecting, and Regulating the Future of Genome Editing: The Significance of ELSPI Perspectives.","authors":"Santa Slokenberga, Timo Minssen, Ana Nordberg","doi":"10.1163/15718093-bja10076","DOIUrl":"https://doi.org/10.1163/15718093-bja10076","url":null,"abstract":"","PeriodicalId":43934,"journal":{"name":"EUROPEAN JOURNAL OF HEALTH LAW","volume":"29 3-5","pages":"327-340"},"PeriodicalIF":0.8,"publicationDate":"2022-04-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10019382","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}
{"title":"Addressing Cognitive Vulnerabilities through Genome and Epigenome Editing: Techno-Legal Adaptations for Persons with Intellectual Disabilities.","authors":"Pin Lean Lau","doi":"10.1163/15718093-bja10085","DOIUrl":"https://doi.org/10.1163/15718093-bja10085","url":null,"abstract":"<p><p>The key aim of this paper is to highlight the oft-under-represented narrative of how persons with disabilities (specifically, those with intellectual disabilities) may access the benefits that genome editing may offer. Firstly, this paper reflects on the critical need for a paradigm shift in how we view intellectual disabilities, and centering the rights of persons with disabilities to allow them to access the broad scope of their right to health under various international law instruments (including the complementary right to habilitation under Article 26 of the CRPD). Secondly, the paper evaluates the legal provisions in the CRPD and other international instruments relating to the rights of persons with intellectual disabilities, and their access to genome editing technologies. This analysis intends to demonstrate that human rights in disability discourse be complemented with emancipatory, participatory, and transformative research. Finally, the paper argues for a reinvigorated line of thinking that expands on the social model of disability: to align with inclusive, contemporary disability discourse that embodies greater responsibility and innovation in perpetuating better access to genome editing technologies for persons with intellectual disabilities.</p>","PeriodicalId":43934,"journal":{"name":"EUROPEAN JOURNAL OF HEALTH LAW","volume":"29 3-5","pages":"409-434"},"PeriodicalIF":0.8,"publicationDate":"2022-04-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10022045","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}
{"title":"Balancing Innovation, 'Ordre Public' and Morality in Human Germline Editing: A Call for More Nuanced Approaches in Patent Law.","authors":"Duncan Matthews, Timo Minssen, Ana Nordberg","doi":"10.1163/15718093-bja10073","DOIUrl":"https://doi.org/10.1163/15718093-bja10073","url":null,"abstract":"<p><p>This article analyses the role that 'ordre public' and morality exceptions can play in the granting of patents on inventions in the field of human germline editing and the consequences of this policy option. In order to provide the context for such an analysis, the article will, first, provide an overview of the current patent landscape for relevant genome editing technologies, drawing attention to recent patent disputes and, second, examine 'ordre public' and morality exceptions under patent law in international, national and regional law, and the implications for innovation and access to novel treatments. The article argues that patent exceptions should not be used as a blunt policy instrument, nor interpreted in a way that is contrary to the patent system's overall objectives. The 'ordre public' and morality based exceptions in the context of human germline editing should not be interpreted and applied in a way which results in outcomes counterproductive to the goal of balancing innovation with the protection of societal higher normative values. Instead, the application of the exception should be based on a sound understanding of both the underlying science as well as the broader ethical, social, and legal implications, thus enabling case-by-case decisions that provide the basis for patent claim amendments and nuanced purpose-bound protection. Further analysis and debate as to the role that such flexibilities can play in the context of genome editing technologies is therefore both necessary and desirable, and can be facilitated in the ways set out in this article.</p>","PeriodicalId":43934,"journal":{"name":"EUROPEAN JOURNAL OF HEALTH LAW","volume":"29 3-5","pages":"562-588"},"PeriodicalIF":0.8,"publicationDate":"2022-04-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10019387","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}
{"title":"What Would It Take to Enable Germline Editing in Europe for Medical Purposes?","authors":"Santa Slokenberga","doi":"10.1163/15718093-bja10074","DOIUrl":"https://doi.org/10.1163/15718093-bja10074","url":null,"abstract":"<p><p>Commonly, the regulation on germline editing in Europe is described through the two prohibitions: the prohibition set out in Article 13 of the Convention for the protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine and the prohibition that is set out in the EU Clinical Trials Regulation. These prohibitions reflect the European regional position regarding the ethical and legal questions raised by the technology, and an unwillingness to enable such interventions in Europe. Simultaneously, these prohibitions have been shaped prior to the recent breakthroughs in the field, such as the discovery of the CRISPR-Cas technology, which has initiated a new era in the field. This contribution examines what it would take to enable human germline gene editing in Europe for medical purposes. It scrutinises in detail the content and context of the existing bans, as well as mechanisms to lift them. It argues that the bans that are prescribed by each of the European regional legal orders are embedded in strong structures, composed of values and principles. For the human germline gene editing to be enabled in Europe for health-related purposes, the approach to these values and principles needs to change. Only then can the machinery to lift the bans lead to a change.</p>","PeriodicalId":43934,"journal":{"name":"EUROPEAN JOURNAL OF HEALTH LAW","volume":"29 3-5","pages":"521-542"},"PeriodicalIF":0.8,"publicationDate":"2022-04-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10022041","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}
{"title":"Genetics and Justice, Non-Ideal Theory and the Role of Patents: The Case of CRISPR-Cas9.","authors":"Oliver Feeney","doi":"10.1163/15718093-bja10075","DOIUrl":"https://doi.org/10.1163/15718093-bja10075","url":null,"abstract":"<p><p>There are ongoing concerns of social justice regarding inequalities in the distribution of access to potential genome editing technologies. Working within non-ideal theory, Colin Farrelly advances a justification for the use of patents to speed up the arrival of safe and effective interventions for all, including the socially disadvantaged. This paper argues that such success is less assured when one considers the actual functioning of patents and the practical implications of the patent system in the context of biotechnological innovations. I suggest that non-ideal theoretical approaches risk reverting back to a form of ideal theory if they simply refer to such real-world constraints - e.g. patents - but do not critically assess and fully examine how such constraints manifest themselves in practice. I highlight some considerations that would be important in order to develop and foster a more robust non-ideal approach to justice in biotechnological developments.</p>","PeriodicalId":43934,"journal":{"name":"EUROPEAN JOURNAL OF HEALTH LAW","volume":"29 3-5","pages":"543-561"},"PeriodicalIF":0.8,"publicationDate":"2022-04-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10016661","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}
{"title":"A Room with a View (and with a Gene Therapy Drug): Gene Therapy Medicinal Products and Genetic Tourism in Europe.","authors":"Vera Lúcia Raposo","doi":"10.1163/15718093-bja10083","DOIUrl":"https://doi.org/10.1163/15718093-bja10083","url":null,"abstract":"<p><p>In contrast to the extreme caution that has been imposed on genetic medical procedures, in European law genetic drugs, or medications, have found a legal loophole that allows flexible (perhaps too flexible) access to these drugs. In Europe, Gene Therapy Medicinal Products are a form of Advanced Therapy Medicinal Products and as such submitted to the marketing authorization procedure. However, there are legal mechanisms in place - such as compassionate use, named patient use, and hospital exception - that allow for their provision to patients without proper approval. This is not, de per se, problematic; the problem arises, though, because such mechanisms are neither properly regulated nor monitored, and their application differs substantially according to the jurisdiction. This disparity and lack of control have given rise to situations of genetic tourism, where patients in desperate need travel to so-called genetic paradises, looking for a miraculous, and extremely expensive cure. The outcome is sometimes tragic, endangering patients' safety and undermining confidence in genetic products.</p>","PeriodicalId":43934,"journal":{"name":"EUROPEAN JOURNAL OF HEALTH LAW","volume":"29 3-5","pages":"504-520"},"PeriodicalIF":0.8,"publicationDate":"2022-04-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10016659","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}