Framing and legitimating EU legal regulation of human gene-editing technologies: key facets and functions of an imaginary

Mahalatchimy, Aurélie; Lau, Pin Lean; Li, Phoebe; Flear, Mark

doi:10.1093/jlb/lsaa080

Cited by 7 publications

(6 citation statements)

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“…97 As long as the core biomedical principles (beneficence, nonmaleficence, autonomy, and justice) are no longer considered as an absolute limit to use germline genome editing, and the National Councils have open room for discussions for its use in the medical interest of patients or their offspring, this position, even though not binding, could influence further revisions of the French Bioethics Law or of EU law in the future. Another example is the imaginary built into the framing of EU level legal regulation of human gene editing technologies, which is based on the tension around naturalness; safeguarding morality and ethics; and the pursuit of medical objectives for the protection of human health (Mahalatchimy et al, 2021). 93 European Medicines Agency and Heads of Medicines Agencies.…”

Section: Discussionmentioning

confidence: 99%

“…25 Within the nonexhaustive and indicative list of processes to which the exclusion from patentability applies, all items are relevant to genome editing. The first two ones are directly related to human genome editing as they mention "processes for cloning human beings" 26 and "processes for modifying the germline genetic identity of human beings" (Li, 2014;Wong and Mahalatchimy, 2018;Mahalatchimy et al, 2021). 27 The last two ones are indirectly related to human genome editing.…”

Section: Substantive Fragmentationmentioning

confidence: 99%

“…Nevertheless, a developing literature already explains how EU law applies throughout the development pipeline for new technologies more generally (Flear, 2017). More specific articles now discuss the current regulatory European framework (EU and Council of Europe levels) 3 on human germline modification (Almqvist and Romano, 2020;Nordberg et al, 2020), the focus of EU legislations on technical risks (Mahalatchimy and Rial-Sebbag, 2020), or the imaginary built into its framing (Mahalatchimy et al, 2021).…”

Section: Introductionmentioning

confidence: 99%

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Deciphering the Fragmentation of the Human Genome Editing Regulatory Landscape

Mahalatchimy

Rial‐Sebbag

2022

Front. Polit. Sci.

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Genome editing techniques have generated a growing interest following the discovery of the so-called CRISPR-Cas technique. It has raised a global uproar as regards its use in humans, especially after the 2018 announcement of a Chinese scientist who had used CRISPR to edit the genes of twin embryos. Indeed, one of the greatest concerns, although not the only one, has been the use of genome editing technologies to modify the human germline. In such scientific and technological context, the law plays a key role in framing what should be allowed or prohibited, and under which conditions, to find a balance between safe and accessible innovative treatments and respect of fundamental rights in accordance with the societal values and choices. Within the European Union, several institutions have considered the issues raised by human genome editing, and several legal texts participate in the establishment of the European regulatory framework applicable to human genome editing. Yet we argue in this article that the established regulatory landscape is fragmented in the sense of being divided, split, or segmented. Such fragmentation, which may have been inevitable for historical and technicolegal reasons, produces effects regarding the role of the current regulatory frameworks applicable to human genome editing. Focusing on the European Union and on the French levels of governance, we discuss how such fragmentation takes place through the identification of determinants of the human genome editing fragmented regulatory landscape. We argue that it should be seen as a process providing more contingent responses to human genome editing reflecting changing political and legal contexts.

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Section: Discussionmentioning

confidence: 99%

Section: Substantive Fragmentationmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Deciphering the Fragmentation of the Human Genome Editing Regulatory Landscape

Mahalatchimy

Rial‐Sebbag

2022

Front. Polit. Sci.

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“…25 Within the Brüstle and ISCO cases, the CJEU has defined the term embryo within the meaning of EU-harmonized patent law. 26 As a result, the CJEU has also commented on the question of the beginning of human life in the legal sense and its protection against destruction and other uses for purposes not supporting the embryo itself. According to this case law, every cellular human entity that has the inherent ability to develop into a human being 27 is an embryo in the meaning of the law.…”

Section: Wrong Status -The Embryo As a Legal Subject And Not As A Leg...mentioning

confidence: 99%

The EU legal framework on clinical trials directed to therapeutic germline gene alteration: A critical and systematic analysis

Faltus

Beriaín

2023

Medical Law International

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Interventions in the human germline, whether for purposes of therapy for a hereditary disease or for purposes of enhancement, are controversial. While enhancement is almost unanimously rejected, therapy-oriented intervention is not a priori regarded as unacceptable. The legal discussion so far has focused primarily on the questions of whether manipulation of the embryo’s germline is permissible or whether the genetic manipulation of germ cells and the use of these germ cells for embryo generation is permissible. Up to now, the upstream questions regarding the systematic germline therapy development in clinical trials have been ignored, including questions as to whether the development of germline therapy would be legally permissible within the European Union framework of clinical studies. This article highlights the legal issues connected with the clinical development of germline intervention, provides an overview of the various answers to these legal questions, and indicates where further research and discussion are needed.

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“…We explore this question by looking at the issues discussed over this period of time and the words most frequently used. Like other authors (i.e., Helliwell et al, 2019; Mahalatchimy et al, 2021; Siebert et al, 2022), we are interested in the “framing” of the discussions. We are not the first to examine debates from a temporal perspective.…”

Section: Introductionmentioning

confidence: 99%

Key and emerging themes in gene editing: A lexicometric analysis of publications in the biological sciences (1990–2022)

Meyer,

Vergnaud

2023

Plants People Planet

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Societal Impact StatementVarious techniques to modify genomes have been developed over the past decades, from molecular cloning to gene editing techniques. What are their applications? What are the key themes discussed by scientists? To answer these questions, we provide a qualitative and quantitative analysis of 14,739 scientific articles published between 1990 to 2022 showing that some themes are constant over time, such as the molecular aspects of genetics and discussions about data and software, while other themes emerged more recently. For example, CRISPR/Cas9 became prominent from 2012 onwards, and applications in agriculture and policy/regulatory implications from 2015 onwards. This mixed method opens up new spaces for dialogue between the natural and social sciences and captures the shifting boundaries of science.Summary The article analyzes publications in the biological sciences concerned with genetic engineering, in particular gene editing, between 1990 and 2022 to examine key and emerging themes. It provides a lexicometric analysis of 14,739 articles, which were subdivided into four periods (1990–2011, 2012–2015, 2016–2018, and 2019–2022). We show that certain themes are constant over time, such as the molecular aspects of genetic engineering techniques and discussions about data and software. Other themes, however, have emerged at specific moments in time: CRISPR/Cas9 became prominent from 2012 onwards and applications in agriculture and policy and regulatory implications from 2015 onwards. We observe, in particular, a semantic shift from genetically modified organisms (GMOs) to crops. The article contributes to debates about the boundaries of science by shedding light on the temporal dynamics of boundary‐work and by showing how the frames of scientific debates can shift to account for the political aspects of science. We conclude that the dialogue between the natural and social sciences can be strengthened by showing that apart from scientometric approaches, there are other methods to analyze “what counts” in science.

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Framing and legitimating EU legal regulation of human gene-editing technologies: key facets and functions of an imaginary

Cited by 7 publications

References 0 publications

Deciphering the Fragmentation of the Human Genome Editing Regulatory Landscape

Deciphering the Fragmentation of the Human Genome Editing Regulatory Landscape

The EU legal framework on clinical trials directed to therapeutic germline gene alteration: A critical and systematic analysis

Key and emerging themes in gene editing: A lexicometric analysis of publications in the biological sciences (1990–2022)

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