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Addressing Cognitive Vulnerabilities through Genome and Epigenome Editing: Techno-Legal Adaptations for Persons with Intellectual Disabilities. 通过基因组和表观基因组编辑解决认知脆弱性:智障人士的技术法律适应。
IF 0.8
EUROPEAN JOURNAL OF HEALTH LAW Pub Date : 2022-04-08 DOI: 10.1163/15718093-bja10085
Pin Lean Lau
{"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}
引用次数: 1
Balancing Innovation, 'Ordre Public' and Morality in Human Germline Editing: A Call for More Nuanced Approaches in Patent Law. 平衡人类生殖系编辑中的创新、“公共秩序”和道德:呼吁在专利法中采取更细致入微的方法。
IF 0.8
EUROPEAN JOURNAL OF HEALTH LAW Pub Date : 2022-04-08 DOI: 10.1163/15718093-bja10073
Duncan Matthews, Timo Minssen, Ana Nordberg
{"title":"Balancing Innovation, 'Ordre Public' and Morality in Human Germline Editing: A Call for More Nuanced Approaches in Patent Law.","authors":"Duncan Matthews,&nbsp;Timo Minssen,&nbsp;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}
引用次数: 0
What Would It Take to Enable Germline Editing in Europe for Medical Purposes? 为了医学目的，在欧洲进行生殖细胞编辑需要什么?
IF 0.8
EUROPEAN JOURNAL OF HEALTH LAW Pub Date : 2022-04-08 DOI: 10.1163/15718093-bja10074
Santa Slokenberga
{"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}
引用次数: 1
Genetics and Justice, Non-Ideal Theory and the Role of Patents: The Case of CRISPR-Cas9. 遗传学与正义，非理想理论和专利的作用:以CRISPR-Cas9为例。
IF 0.8
EUROPEAN JOURNAL OF HEALTH LAW Pub Date : 2022-04-08 DOI: 10.1163/15718093-bja10075
Oliver Feeney
{"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}
引用次数: 0
A Room with a View (and with a Gene Therapy Drug): Gene Therapy Medicinal Products and Genetic Tourism in Europe. 一间有景观的房间(和一种基因治疗药物):欧洲的基因治疗药物产品和基因旅游。
IF 0.8
EUROPEAN JOURNAL OF HEALTH LAW Pub Date : 2022-04-08 DOI: 10.1163/15718093-bja10083
Vera Lúcia Raposo
{"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}
引用次数: 0
The Object-Based and Process-Based Regulation of Genome Editing. 基于对象和基于过程的基因组编辑调控。
IF 0.8
EUROPEAN JOURNAL OF HEALTH LAW Pub Date : 2022-04-08 DOI: 10.1163/15718093-bja10078
Michal Koščík, Eliška Vladíková
{"title":"The Object-Based and Process-Based Regulation of Genome Editing.","authors":"Michal Koščík,&nbsp;Eliška Vladíková","doi":"10.1163/15718093-bja10078","DOIUrl":"https://doi.org/10.1163/15718093-bja10078","url":null,"abstract":"<p><p>The article explores whether the broader regulatory framework applicable to the member states of the EU contains suitable tools to react to the rapid advances in science, especially as to the question of germline editing technologies. From the perspective of EU member states, the regulatory framework is fragmented between norms of international law, secondary EU law and national legislation. The rules and their interpretation are strongly influenced by the concept of precaution, which reflects the concern that there is not enough knowledge to assess the impact of genome editing technology on individuals, society and future populations. However, the argument of precaution loses its strength with every new scientific discovery. The expanding knowledge in the field creates the need to replace regulation, which is based on the lack of knowledge (such as precautionary moratoriums) by the regulation that is based on the actual knowledge. The article reaches a conclusion that the EU framework for advanced treatments and medicinal products is in a state where it can, in principle, address the questions associated with the safety and efficacy of germline editing technologies. The EU framework is, however, not suitable to assess the moral and societal impacts of new technology, which should be left for member states.</p>","PeriodicalId":43934,"journal":{"name":"EUROPEAN JOURNAL OF HEALTH LAW","volume":"29 3-5","pages":"484-503"},"PeriodicalIF":0.8,"publicationDate":"2022-04-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10019384","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
Regulating Heritable Human Genome Editing: Drawing the Line between Legitimate and Controversial Use. 调节可遗传的人类基因组编辑:在合法和有争议的使用之间划清界限。
IF 0.8
EUROPEAN JOURNAL OF HEALTH LAW Pub Date : 2022-04-08 DOI: 10.1163/15718093-bja10080
Noemi Conditi
{"title":"Regulating Heritable Human Genome Editing: Drawing the Line between Legitimate and Controversial Use.","authors":"Noemi Conditi","doi":"10.1163/15718093-bja10080","DOIUrl":"https://doi.org/10.1163/15718093-bja10080","url":null,"abstract":"<p><p>In general, to modify the human germline is prohibited. However, regulating the use of HHGE might be a more efficient method than the actual ban. Indeed, when genome editing is safe for introduction in clinical practices, it is frequently proposed that the prohibition is lifted solely for therapeutic purposes, i.e., to eliminate serious genetic diseases. Definitions of the concepts of health and disease are controversial and may only be reached by adopting a value-laden approach, which may rise concerns about legal certainty and have possible discriminatory effects. Nor the threshold of the seriousness of the disease might be used to solve these issues. A different model might then be adopted for the assessment of the permissibility of HHGE, i.e., the PGD model. However, such model should not be implemented as the only criterion, but should rather be a \"minimum threshold\": HHGE should be allowed whenever used to correct a genetic defect for which PGD is possible.</p>","PeriodicalId":43934,"journal":{"name":"EUROPEAN JOURNAL OF HEALTH LAW","volume":"29 3-5","pages":"435-457"},"PeriodicalIF":0.8,"publicationDate":"2022-04-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10019385","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 Application of EU Competition Law to the Exploitation of Human Genome Editing Technology. 欧盟竞争法在人类基因组编辑技术利用中的应用。
IF 0.8
EUROPEAN JOURNAL OF HEALTH LAW Pub Date : 2022-04-08 DOI: 10.1163/15718093-bja10077
Vladimir Bastidas Venegas
{"title":"The Application of EU Competition Law to the Exploitation of Human Genome Editing Technology.","authors":"Vladimir Bastidas Venegas","doi":"10.1163/15718093-bja10077","DOIUrl":"https://doi.org/10.1163/15718093-bja10077","url":null,"abstract":"<p><p>This paper explores the application of EU Competition Law to the exploitation of human genome editing technology. Holders of key patents in the sector have applied different methods for disseminating the technology, such as different forms of licensing agreement and patent pools. It is found that that the competition rules are ill-suited to assess some of the licensing arrangements applied, which give rise to legal uncertainty. Accordingly, holders of patents on human genome editing technology may be discouraged to apply efficient methods for disseminating the technology. This may delay or obstruct some of the benefits the technology is supposed to deliver to the market, maker actors and consumers.</p>","PeriodicalId":43934,"journal":{"name":"EUROPEAN JOURNAL OF HEALTH LAW","volume":"29 3-5","pages":"589-619"},"PeriodicalIF":0.8,"publicationDate":"2022-04-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10022044","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
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
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