{"id":4178,"date":"2025-07-10T16:08:27","date_gmt":"2025-07-10T14:08:27","guid":{"rendered":"https:\/\/confluencedesdroits-larevue.com\/?p=4178"},"modified":"2025-07-10T16:08:28","modified_gmt":"2025-07-10T14:08:28","slug":"adrien-bottacci-the-multifaceted-definition-of-organoids-in-law","status":"publish","type":"post","link":"https:\/\/confluencedesdroits-larevue.com\/?p=4178","title":{"rendered":"Adrien Bottacci \u2013 The Multifaceted Definition of\u00a0Organoids in\u00a0Law"},"content":{"rendered":"\n
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Adrien Bottacci
Doctorant contractuel, Aix Marseille Univ, CNRS, EFS, ADES, CDSA, Marseille, France<\/p>\n<\/div><\/div>\n\n\n\n

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This article examines the definitions applicable to organoids in European Union (EU) law and French law to outline the state of their fragmented regulatory landscape. By analysing relevant European and national hard law and soft law, we will extract key definitional features of organoids. While the field is still relatively new, elements of definition are sprouting in various instances. By comparing this early understanding of organoids in law to the myriad of future applications possible -as research tools, as medicines or even as commodities-, it will become apparent which technological pathways are still in lack of regulatory attention. Only by paying attention to the road less travelled will we ensure fostering innovation, promoting responsible research practices, and balancing societal benefits with potential risks. This article contributes to the ongoing discourse on regulatory concepts used in science and technology by shedding light on the complex interplay between law, ethics and innovation through an analysis of definitions applicable to organoids in law. This article ultimately highlights the importance of proactive yet nuanced regulatory measures that keep pace with the rapid technological developments in organoid research.<\/p>\n\n\n\n

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Multifaceted-Definition-of-Organoids-in-Law_A.-Bottacci-07-25<\/a><\/a><\/div>\n\n\n\n
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assembloids<\/a>, <\/span>definition<\/a>, <\/span>embryoids<\/a>, <\/span>European Union law<\/a>, <\/span>french law<\/a>, <\/span>medicinal products<\/a>, <\/span>new approach methodologies<\/a>, <\/span>organoids<\/a>, <\/span>Substances of human origin<\/a><\/div>\n\n\n
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Any attempt at reaching the essence of an object should strive to follow Plotinus\u2019s dictum: \u201cIf one wants to know the nature of one thing, one must examine it in its pure state, since every addition to a thing is an obstacle to the knowledge of that thing\u201d.1<\/sup><\/a> Formulating a definitive statement about the nature of an object can only be made by setting aside all superfluous elements and focusing on its necessary and sufficient characteristics. However, such an essentialist approach can prove thorny when each element of the so-called pure state can manifest endless variations. This is the crux of the matter when attempting to define organoids. They do not constitute a pure and uniform class of objects. Instead, organoids are a fuzzy category composed of different clusters of objects. Broadly speaking, they are self-organising three-dimensional cellular structures derived from stem cells2<\/sup><\/a> that can reproduce some physiological and structural features of an organ. Thus, the biological definition of organoids has been narrowed down to three main characteristics: (1) the presence of multiple cell types, (2) that are undergoing a process of self-organisation in three dimensions, (3) which reproduce structural and physiological features of an in vivo<\/em> tissue.3<\/sup><\/a> However, each variation on these criteria produces different types of organoid models. Following are a few examples of these possible variations:<\/p>\n\n\n\n