{"id":4175,"date":"2025-07-10T16:03:13","date_gmt":"2025-07-10T14:03:13","guid":{"rendered":"https:\/\/confluencedesdroits-larevue.com\/?p=4175"},"modified":"2025-07-10T17:39:56","modified_gmt":"2025-07-10T15:39:56","slug":"aurelie-mahalatchimy-xavier-magnon-marie-glinel-pourquoi-un-dossier-sur-les-definitions-et-les-concepts-du-biodroit","status":"publish","type":"post","link":"https:\/\/confluencedesdroits-larevue.com\/?p=4175","title":{"rendered":"Aur\u00e9lie Mahalatchimy, Xavier Magnon, Marie Glinel \u2013 Pourquoi un\u00a0dossier sur les d\u00e9finitions et les concepts du\u00a0biodroit\u00a0?"},"content":{"rendered":"\n<div class=\"wp-block-group alignwide is-layout-constrained wp-block-group-is-layout-constrained\"><div class=\"wp-block-group__inner-container\">\n<div class=\"wp-block-media-text alignwide has-background\" style=\"background-color:#edf7fb;grid-template-columns:15% auto\"><figure class=\"wp-block-media-text__media\"><img decoding=\"async\" loading=\"lazy\" width=\"249\" height=\"283\" src=\"https:\/\/confluencedesdroits-larevue.com\/wp-content\/uploads\/2025\/07\/01-Aurelie_Mahalatchimy.png\" alt=\"\" class=\"wp-image-4311 size-full\" srcset=\"https:\/\/confluencedesdroits-larevue.com\/wp-content\/uploads\/2025\/07\/01-Aurelie_Mahalatchimy.png 249w, https:\/\/confluencedesdroits-larevue.com\/wp-content\/uploads\/2025\/07\/01-Aurelie_Mahalatchimy-132x150.png 132w\" sizes=\"(max-width: 249px) 100vw, 249px\" \/><\/figure><div class=\"wp-block-media-text__content\">\n<p class=\"has-text-align-center has-white-color has-text-color has-background has-normal-font-size\" style=\"background-color:#008cb4\">Aur\u00e9lie Mahalatchimy<br>Charg\u00e9e de recherche au CNRS en droit, Aix Marseille Univ, CNRS, DICE, CERIC, Aix-en-Provence, France<\/p>\n<\/div><\/div>\n\n\n\n<div style=\"height:10px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-media-text alignwide has-background\" style=\"background-color:#edf7fb;grid-template-columns:15% auto\"><figure class=\"wp-block-media-text__media\"><img decoding=\"async\" loading=\"lazy\" width=\"1020\" height=\"1020\" src=\"https:\/\/confluencedesdroits-larevue.com\/wp-content\/uploads\/2025\/07\/01-Xavier_Magnon.jpg\" alt=\"\" class=\"wp-image-4313 size-full\" srcset=\"https:\/\/confluencedesdroits-larevue.com\/wp-content\/uploads\/2025\/07\/01-Xavier_Magnon.jpg 1020w, https:\/\/confluencedesdroits-larevue.com\/wp-content\/uploads\/2025\/07\/01-Xavier_Magnon-300x300.jpg 300w, https:\/\/confluencedesdroits-larevue.com\/wp-content\/uploads\/2025\/07\/01-Xavier_Magnon-150x150.jpg 150w, https:\/\/confluencedesdroits-larevue.com\/wp-content\/uploads\/2025\/07\/01-Xavier_Magnon-768x768.jpg 768w, https:\/\/confluencedesdroits-larevue.com\/wp-content\/uploads\/2025\/07\/01-Xavier_Magnon-600x600.jpg 600w\" sizes=\"(max-width: 1020px) 100vw, 1020px\" \/><\/figure><div class=\"wp-block-media-text__content\">\n<p class=\"has-text-align-center has-white-color has-text-color has-background has-normal-font-size\" style=\"background-color:#008cb4\">Xavier Magnon<br>Professeur de droit public, Aix Marseille Univ, CNRS, DICE, ILF, Aix-en-Provence, France<\/p>\n<\/div><\/div>\n\n\n\n<div style=\"height:10px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-media-text alignwide has-background\" style=\"background-color:#edf7fb;grid-template-columns:15% auto\"><figure class=\"wp-block-media-text__media\"><img decoding=\"async\" loading=\"lazy\" width=\"1024\" height=\"1024\" src=\"https:\/\/confluencedesdroits-larevue.com\/wp-content\/uploads\/2025\/07\/01-Marie_Glinel-1024x1024.jpg\" alt=\"\" class=\"wp-image-4312 size-full\" srcset=\"https:\/\/confluencedesdroits-larevue.com\/wp-content\/uploads\/2025\/07\/01-Marie_Glinel-1024x1024.jpg 1024w, https:\/\/confluencedesdroits-larevue.com\/wp-content\/uploads\/2025\/07\/01-Marie_Glinel-300x300.jpg 300w, https:\/\/confluencedesdroits-larevue.com\/wp-content\/uploads\/2025\/07\/01-Marie_Glinel-150x150.jpg 150w, https:\/\/confluencedesdroits-larevue.com\/wp-content\/uploads\/2025\/07\/01-Marie_Glinel-768x768.jpg 768w, https:\/\/confluencedesdroits-larevue.com\/wp-content\/uploads\/2025\/07\/01-Marie_Glinel-600x600.jpg 600w, https:\/\/confluencedesdroits-larevue.com\/wp-content\/uploads\/2025\/07\/01-Marie_Glinel.jpg 1440w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/figure><div class=\"wp-block-media-text__content\">\n<p class=\"has-text-align-center has-white-color has-text-color has-background has-normal-font-size\" style=\"background-color:#008cb4\">Marie Glinel<br>Ma\u00eetre de conf\u00e9rence en droit public \u00e0 l&rsquo;Universit\u00e9 Lyon II Lumi\u00e8re<\/p>\n<\/div><\/div>\n\n\n\n<div style=\"height:10px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n<\/div><\/div>\n\n\n<div >\n        <div class=\" plethoraplugins-tabs-container plethoraplugins-tabs-container--horizontal plethoraplugins-theme__minimal plethoraplugins-theme__basic \" \n\t\t\tdata-pds-tabs--layout=\"horizontal\"  \n\t\t\tdata-pds-tabs--theme=\"basic\"  \n\t\t\tdata-pds-tabs--mobile-breakpoint-forced=\"\"\n\t\t\t data-pds-tabs--responsive=\"accordion\" \n\t\t\t\t\t data-pds-tabs--responsive-accordion-collapsed-initially=\"false\" data-pds-tabs--accordion-icon-type=\"\" data-pds-tabs--accordion-icon=\"true\"  data-pds-tabs--accordion-icon-size=\"\"  data-pds-tabs--accordion-heading-level=\"h3\" data-pds-tabs--accordion-auto-close=\"true\" >\n            <div class=\"plethoraplugins-tabs\"  >\n              <ul><li>\n                        <a \n                                href=\"#fr\"\n                                class=\" active\" \n                            >\n                            <span>FR<\/span>\n                        <\/a>\n                    <\/li><li>\n                        <a \n                                href=\"#eng\"\n                                class=\"\" \n                            >\n                            <span>ENG<\/span>\n                        <\/a>\n                    <\/li><\/ul>\n            <\/div>\n            <div class=\"plethoraplugins-tabs--content\" >\n                \n<div class=\"\"  data-pds-tabs--accordion-initially-open=\"false\" >\n\n<div class=\"wp-block-file\"><a id=\"wp-block-file--media-b9b54e95-6640-4557-be5e-1a42d3ebc85e\" href=\"https:\/\/confluencedesdroits-larevue.com\/wp-content\/uploads\/2025\/07\/Pourquoi-un-dossier-sur-les-definitions-et-les-concepts-du-biodroit_A.-Mahalatchimy_X.-Magnon_M.-Glinel-07-25.pdf\">Pourquoi-un-dossier-sur-les-definitions-et-les-concepts-du-biodroit_A.-Mahalatchimy_X.-Magnon_M.-Glinel-07-25<\/a><a href=\"https:\/\/confluencedesdroits-larevue.com\/wp-content\/uploads\/2025\/07\/Pourquoi-un-dossier-sur-les-definitions-et-les-concepts-du-biodroit_A.-Mahalatchimy_X.-Magnon_M.-Glinel-07-25.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-b9b54e95-6640-4557-be5e-1a42d3ebc85e\"><\/a><\/div>\n\n\n\n<div style=\"height:50px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p><em>Les auteurs remercient grandement le professeur Tamara K. Hervey pour ses commentaires pr\u00e9cieux lors de la r\u00e9daction de cet introduction du dossier.<\/em><\/p>\n\n\n\n<div style=\"height:50px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p class=\"has-text-align-justify has-background\" style=\"background-color:#edf7fb\">Les concepts et les d\u00e9finitions jouent un r\u00f4le central en droit, en ce qu\u2019ils permettent respectivement de nommer et de d\u00e9crire, d\u00e9limiter une chose r\u00e9elle ou fictive, et de s\u2019assurer d\u2019une compr\u00e9hension commune \u00e0 son sujet, en vue de la qualifier pour lui associer un r\u00e9gime juridique. En inscrivant notre r\u00e9flexion autour du \u00ab\u202fconcept\u202f\u00bb, nous entendons d\u00e9passer la seule r\u00e9flexion notionnelle. Il sera, autant que possible, question de <em>concepts<\/em> et non pas de <em>notions<\/em>, la r\u00e9flexion sur la \u00ab\u202fnotion\u202f\u00bb \u00e9tant consid\u00e9r\u00e9e ici comme un pr\u00e9alable n\u00e9cessaire \u00e0 une r\u00e9flexion sur le \u00ab\u202fconcept\u202f\u00bb. Nous proposons de consid\u00e9rer que la r\u00e9flexion notionnelle implique la recherche de tous les crit\u00e8res susceptibles d\u2019\u00eatre mobilis\u00e9s pour identifier un \u00e9l\u00e9ment du r\u00e9el, avec exhaustivit\u00e9, en identifiant et en discutant chaque crit\u00e8re, sans pour autant trancher entre eux dans leur pertinence \u00e0 identifier le r\u00e9el. Distinctement, la r\u00e9flexion conceptuelle imposera de choisir parmi ces crit\u00e8res seulement ceux qui sont pertinents pour identifier le r\u00e9el, et de situer chaque crit\u00e8re retenu \u00e0 sa juste place pour r\u00e9v\u00e9ler la typicit\u00e9 de l\u2019objet d\u00e9crit. Pour la science du droit en tant que discours savant sur le droit, l\u2019op\u00e9ration de conceptualisation appara\u00eet comme tenant au c\u0153ur de la d\u00e9marche scientifique. Les \u00e9tudes de th\u00e9orie du droit, ou plus largement de recherche fondamentale en sciences juridiques, sont nombreuses sur le sujet<a id=\"_ftnref1\" href=\"#_ftn1\"><sup>[1]<\/sup><\/a>.<br><br>Dans le domaine du biodroit, entendu ici comme le droit et les diverses questions juridiques relatives au biologique et\/ou d\u00e9coulant des avanc\u00e9es technologiques li\u00e9es \u00e0 la biom\u00e9decine, et plus largement \u00e0 la biotechnologie, les d\u00e9finitions et les concepts soul\u00e8vent des enjeux particuliers, rarement \u00e9tudi\u00e9s de fa\u00e7on frontale et transversale par la doctrine<a id=\"_ftnref2\" href=\"#_ftn2\"><sup>[2]<\/sup><\/a>. Pourtant, ils sont d\u00e9cisifs dans ce domaine face \u00e0 des pratiques scientifiques \u00e9volutives et impr\u00e9visibles dans le temps et \u00e0 des d\u00e9finitions scientifiques qui ne sont pas toujours consensuelles. \u00c9tablir des d\u00e9finitions constitue donc un enjeu majeur pour le biodroit afin de saisir et d\u2019orienter de mani\u00e8re satisfaisante ces pratiques. Si le biodroit peut lui-m\u00eame \u00eatre approch\u00e9 comme un concept de la science du droit, il est ici consid\u00e9r\u00e9 en priorit\u00e9 comme un domaine, le champ d\u2019\u00e9tude de ce dossier. Les travaux int\u00e9gr\u00e9s \u00e0 ce champ participent n\u00e9anmoins \u00e0 la conceptualisation du biodroit dont l\u2019utilisation, \u00e0 tout le moins comme expression doctrinale, gagnerait \u00e0 \u00eatre homog\u00e9n\u00e9is\u00e9e.<br><br>Le sujet soul\u00e8ve en effet tout un ensemble de probl\u00e8mes concrets\u2009: est-il possible pour la loi ou la r\u00e9glementation de d\u00e9finir de nouvelles innovations dans les domaines de la biom\u00e9decine ou de la biotechnologie dont le d\u00e9veloppement est en cours, ou des domaines scientifiques et technologiques pr\u00e9sentant des risques inconnus\u2009? Quel degr\u00e9 de libert\u00e9 est-il possible de s\u2019accorder dans les d\u00e9finitions l\u00e9gales ou r\u00e9glementaires face \u00e0 celles retenues par les scientifiques\u2009? Quelle l\u00e9gitimit\u00e9 peut avoir le juriste \u00e0 s\u2019\u00e9loigner des d\u00e9finitions scientifiques\u2009? Est-il pr\u00e9f\u00e9rable d\u2019\u00e9viter de d\u00e9finir un objet \u00e0 r\u00e9glementer en raison de la difficult\u00e9 \u00e0 suivre un domaine technique et \u00e9volutif\u2009? Quand et pourquoi la loi ou le r\u00e8glement ont-ils choisi de d\u00e9finir ou de ne pas d\u00e9finir des innovations biom\u00e9dicales ou des biotechnologies\u2009? Quand et pourquoi la loi ou le r\u00e8glement ont-ils choisi de d\u00e9finir et de r\u00e9glementer en fonction de l\u2019utilisation finale plut\u00f4t que de l\u2019objet lui-m\u00eame\u2009?<br><br>Alors que la litt\u00e9rature juridique se concentre g\u00e9n\u00e9ralement sur les r\u00e9gimes juridiques \u00e0 adopter et sur les d\u00e9fis pos\u00e9s \u00e0 cette r\u00e9glementation par les innovations biom\u00e9dicales et biotechnologiques, ce dossier se concentre sur la mani\u00e8re dont la l\u00e9gislation, ou la r\u00e9glementation plus g\u00e9n\u00e9ralement, les d\u00e9finit ou ne les d\u00e9finit pas, et sur les cons\u00e9quences des d\u00e9finitions et concepts sur le d\u00e9veloppement de ces innovations.<\/p>\n\n\n\n<h2 class=\"wp-block-heading has-text-align-center has-medium-font-size\"><strong>I. Les conventions de langage\u2009: \u00ab\u202fconcept\u202f\u00bb et \u00ab\u202fd\u00e9finition\u202f\u00bb<\/strong><\/h2>\n\n\n\n<p class=\"has-text-align-justify has-background\" style=\"background-color:#edf7fb\">Afin de structurer les \u00e9changes et la compr\u00e9hension dans l\u2019usage des termes \u00ab\u202fconcept\u202f\u00bb et \u00ab\u202fd\u00e9finition\u202f\u00bb, nous avons propos\u00e9 aux contributeurs de retenir certaines conventions de langage autour du sens et des usages de ces termes.<br><br>Ainsi, nous proposons de d\u00e9signer par\u2009:<\/p>\n\n\n\n<ul>\n<li><em>d\u00e9nomination<\/em> du concept, le nom donn\u00e9 au concept,<\/li>\n\n\n\n<li><em>intension<\/em> ou <em>d\u00e9finition<\/em> du concept, la proposition form\u00e9e d\u2019un \u00e9nonc\u00e9 linguistique visant \u00e0 identifier une r\u00e9alit\u00e9 d\u00e9termin\u00e9e (celle qui entre sous la d\u00e9nomination du concept) \u00e0 partir de sa typicit\u00e9,<\/li>\n\n\n\n<li><em>extension<\/em> du concept, toutes les situations qui sont couvertes par le concept, que celui-ci permet de qualifier<a href=\"#_ftn3\" id=\"_ftnref3\"><sup>[3]<\/sup><\/a>.<\/li>\n<\/ul>\n\n\n\n<p class=\"has-text-align-justify has-background\" style=\"background-color:#edf7fb\">Ainsi, le mot \u00ab\u202fChaise\u202f\u00bb est la <em>d\u00e9nomination<\/em> du concept visant \u00e0 d\u00e9crire \u00ab\u202fun meuble avec dossier et sans accoudoir, con\u00e7u pour \u00eatre utilis\u00e9 par une seule personne pour s\u2019assoir\u202f\u00bb, ce qui constitue la <em>d\u00e9finition<\/em> du concept\u2009; tous les meubles avec dossier et sans accoudoir, con\u00e7us pour \u00eatre utilis\u00e9 par une seule personne pour s\u2019assoir sont des <em>extensions<\/em> du concept (ils sont des chaises).<br><br>Dans un \u00e9nonc\u00e9 linguistique se r\u00e9f\u00e9rant \u00e0 un concept, il est possible d\u2019identifier celui-ci dans ses trois dimensions\u2009: sa d\u00e9nomination, sa d\u00e9finition ou son extension.<br><br>L\u2019\u00e9nonc\u00e9 \u00ab\u202fje me suis assis sur une <em>chaise\u202f<\/em>\u00bb utilise la <em>d\u00e9nomination<\/em> du concept, celui \u00ab\u202fje me suis assis sur <em>un meuble <\/em>avec dossier et sans accoudoir, con\u00e7u pour \u00eatre utilis\u00e9 par une seule personne<em> pour s\u2019assoir<\/em>\u202f\u00bb, sa <em>d\u00e9finition<\/em> et ce dernier, \u00ab\u202fje me suis assis sur <em>la chaise de la salle \u00e0 manger<\/em>\u202f\u00bb, une <em>extension <\/em>du concept. Le langage peut parfaitement mobiliser de mani\u00e8re dissoci\u00e9e la d\u00e9nomination du concept, sa d\u00e9finition ou son extension, m\u00eame si, dans notre exemple, la proposition qui constitue l\u2019extension du concept use de sa d\u00e9nomination (\u00ab\u202fla chaise de la salle \u00e0 manger\u202f\u00bb est une \u00ab\u202fchaise\u202f\u00bb, pour la d\u00e9signer le terme de \u00ab\u202fchaise\u202f\u00bb est employ\u00e9).<br><br>Le droit, en ce qu\u2019il est formul\u00e9 \u00e0 partir d\u2019\u00e9nonc\u00e9s linguistiques, peut donc soit user de la d\u00e9nomination d\u2019un concept, soit poser sa d\u00e9finition, soit en constituer l\u2019extension. En effet, si le droit applicable d\u00e9finit parfois les concepts qu\u2019il utilise pour d\u00e9terminer l\u2019\u00e9tendue des droits et obligations juridiques qu\u2019il \u00e9tablit, il contient \u00e9galement de nombreux concepts qui sont mobilis\u00e9s sans \u00eatre d\u00e9finis. Dans ce contexte, le droit de l\u2019Union europ\u00e9enne (UE) est un bon exemple de cette d\u00e9marche pour d\u00e9finir divers concepts juridiques au d\u00e9but des directives et des r\u00e8glements, avant les articles qui les constituent, m\u00eame si tous les concepts mobilis\u00e9s ne sont pas toujours d\u00e9finis. Pour illustrer cette situation, dans le domaine du biodroit o\u00f9 la l\u00e9gislation de l\u2019UE sur les m\u00e9dicaments est parfois applicable, la proposition de r\u00e9forme de la l\u00e9gislation pharmaceutique montre de mani\u00e8re significative la volont\u00e9 de d\u00e9finir les concepts et de les rendre accessibles en augmentant le nombre de d\u00e9finitions disponibles de 33 dans le code communautaire actuel<a id=\"_ftnref4\" href=\"#_ftn4\"><sup>[4]<\/sup><\/a> \u00e0 70&nbsp;d\u00e9finitions dans la r\u00e9vision propos\u00e9e<a id=\"_ftnref5\" href=\"#_ftn5\"><sup>[5]<\/sup><\/a>. Certaines de ces d\u00e9finitions existent d\u00e9j\u00e0 mais sont dispers\u00e9es dans divers autres textes juridiques, y compris des lignes directrices, comme pour les \u00ab\u202fvaccins\u202f\u00bb<a id=\"_ftnref6\" href=\"#_ftn6\"><sup>[6]<\/sup><\/a>, tandis que d\u2019autres sont actuellement nomm\u00e9es sans \u00eatre d\u00e9finies, comme pour le terme \u00ab\u202fnon-clinique\u202f\u00bb que la proposition de r\u00e9forme pr\u00e9voit de d\u00e9finir<a id=\"_ftnref7\" href=\"#_ftn7\"><sup>[7]<\/sup><\/a>. Contrairement \u00e0 la proposition de r\u00e9forme de la l\u00e9gislation pharmaceutique, le r\u00e8glement (UE) 2024\/1938 concernant les normes de qualit\u00e9 et de s\u00e9curit\u00e9 des substances d\u2019origine humaine destin\u00e9es \u00e0 une application humaine (ci-apr\u00e8s \u00ab\u202fr\u00e8glement SoHO\u202f\u00bb)<a id=\"_ftnref8\" href=\"#_ftn8\"><sup>[8]<\/sup><\/a> fera dispara\u00eetre les d\u00e9finitions juridiques actuelles de sang, cellules et tissus, au b\u00e9n\u00e9fice d\u2019un nouveau concept juridique \u00ab\u202fles substances d\u2019origine humaine\u202f\u00bb.<br><br>Ainsi, l\u2019article&nbsp;3.1 du r\u00e8glement SoHO pr\u00e9voit \u00ab\u202fAux fins du pr\u00e9sent r\u00e8glement, on entend par\u2009: \u201csubstance d\u2019origine humaine\u201d ou \u201cSoHO\u201d\u2009: toute substance pr\u00e9lev\u00e9e du corps humain, qu\u2019elle contienne ou non des cellules et que ces cellules soient vivantes ou non, y compris les pr\u00e9parations \u00e0 base de SoHO issues de la transformation d\u2019une telle substance.\u202f\u00bb Il contient ainsi la d\u00e9nomination du concept avec le terme \u00ab\u202fsubstance d\u2019origine humaine\u202f\u00bb, tout en le d\u00e9finissant. Concernant l\u2019extension du concept, toute substance pr\u00e9lev\u00e9e d\u2019un corps humain contenant ou non des cellules, vivantes ou non, peut \u00eatre qualifi\u00e9e de \u00ab\u202fsubstance d\u2019origine humaine\u202f\u00bb. Ainsi, en sera-t-il, par exemple, du sang, de ses composants, des cellules, des tissus, du microbiote, de l\u2019urine ou des f\u00e8ces d\u2019origine humaine ou encore du lait maternel.<br><br>Cette pr\u00e9cision faite, les \u00e9nonc\u00e9s susceptibles de mobiliser chacun des \u00e9l\u00e9ments du concept sont de plusieurs types\u2009: les \u00e9nonc\u00e9s <em>du<\/em> droit d\u2019une part, qui sont directement \u00e9nonc\u00e9s dans un texte juridique<a id=\"_ftnref9\" href=\"#_ftn9\"><sup>[9]<\/sup><\/a>, doivent \u00eatre distingu\u00e9s, d\u2019autre part, des \u00e9nonc\u00e9s <em>sur le<\/em> droit, qui proviennent d\u2019un discours au sujet du droit<a id=\"_ftnref10\" href=\"#_ftn10\"><sup>[10]<\/sup><\/a>. En ce sens, nous sugg\u00e9rons, lorsque le concept (sa d\u00e9nomination, sa d\u00e9finition ou son extension) est <em>dans <\/em>le droit, qu\u2019il soit consid\u00e9r\u00e9 comme un <em>concept juridique<\/em> (du moins sa d\u00e9nomination, sa d\u00e9finition ou son extension est-elle juridique, d\u00e9clinaisons valables pour les diff\u00e9rentes cat\u00e9gories de concept distingu\u00e9es apr\u00e8s). Si le concept est dans les \u00e9nonc\u00e9s <em>sur le<\/em> droit, du moins dans le discours savant sur le droit, nous sugg\u00e9rons de dire qu\u2019il est un <em>concept de la science du droit<\/em>. Ainsi en est-il, par exemple, du concept \u00ab\u202fd\u2019innovation biom\u00e9dicale\u202f\u00bb, utilis\u00e9 dans le cadre du projet ANR I-BioLex, mentionn\u00e9 ci-dessous. Le terme n\u2019est pas mobilis\u00e9 par le droit positif mais par la science du droit.<br><br>Compte tenu du sujet, nos analyses doctrinales incluront \u00e9galement d\u2019autres discours susceptibles de mobiliser les concepts dans leurs trois dimensions. Tout d\u2019abord, et plus particuli\u00e8rement, les discours scientifiques en g\u00e9n\u00e9ral, autres que ceux de la science du droit, pourront \u00eatre mobilis\u00e9s. Nous sugg\u00e9rons alors de parler de <em>concept scientifique<\/em>, l\u2019adjectif qualificatif pouvant \u00eatre d\u00e9clin\u00e9 selon les disciplines (discours scientifique de la m\u00e9decine (concept m\u00e9dical), de la philosophie (concept philosophique), de la sociologie (concept sociologique), etc.). \u00c0 l\u2019oppos\u00e9, nous proposons de qualifier de communs, les discours qui mobilisent le sens commun et\/ou intuitif d\u2019une r\u00e9alit\u00e9 d\u00e9termin\u00e9e, et qui ne rel\u00e8vent d\u2019aucune d\u00e9marche scientifique\u2009: ils seront donc qualifi\u00e9s de <em>concept commun<\/em>.<br><br>Ainsi, un <em>concept<\/em>, dans sa <em>d\u00e9nomination<\/em>, sa <em>d\u00e9finition<\/em> ou son <em>extension<\/em> peut \u00eatre qualifi\u00e9 de\u2009:<\/p>\n\n\n\n<ul>\n<li><em>concept juridique<\/em> s\u2019il est contenu dans des dispositions de droit positif (texte juridique applicable quelle que soit sa source ou son statut (loi, d\u00e9cret, d\u00e9cision de justice\u2026) \u00e0 un moment donn\u00e9 dans un ordre juridique donn\u00e9)\u2009;<\/li>\n\n\n\n<li><em>concept de la science du droit<\/em> lorsqu\u2019il est mobilis\u00e9 par le discours savant sur le droit\u2009;<\/li>\n\n\n\n<li><em>concept scientifique<\/em> (de philosophie, de m\u00e9decine, de sociologie, etc.) lorsqu\u2019il est pos\u00e9 par un discours scientifique autre que celui qui porte sur le droit\u2009;<\/li>\n\n\n\n<li><em>concept commun<\/em> lorsque les dimensions connues (d\u00e9nomination, d\u00e9finition, et\/ou extension) de ce concept reposent sur des \u00e9l\u00e9ments communs, non scientifiques.<\/li>\n<\/ul>\n\n\n\n<p class=\"has-text-align-justify has-background\" style=\"background-color:#edf7fb\">Les concepts juridiques peuvent mobiliser des concepts scientifiques, des concepts communs et des concepts de la science du droit. Par exemple, le concept juridique de \u00ab\u202fsubstance d\u2019origine humaine\u202f\u00bb mobilise \u00e0 la fois d\u2019autres concepts juridiques comme les \u00ab\u202fpr\u00e9parations \u00e0 base de SoHO\u202f\u00bb<a href=\"#_ftn11\" id=\"_ftnref11\"><sup>[11]<\/sup><\/a> et la \u00ab\u202ftransformation\u202f\u00bb<a href=\"#_ftn12\" id=\"_ftnref12\"><sup>[12]<\/sup><\/a>, qui seront ainsi appel\u00e9s \u00e0 devenir des concepts de la science du droit, les concepts scientifiques de \u00ab\u202fcellules vivantes ou non\u202f\u00bb, et le concept commun de \u00ab\u202fcorps humain\u202f\u00bb.<\/p>\n\n\n\n<h2 class=\"wp-block-heading has-text-align-center has-medium-font-size\"><strong>II. Le contexte\u2009: un dossier s\u2019inscrivant dans le projet I-BioLex<\/strong><\/h2>\n\n\n\n<p class=\"has-text-align-justify has-background\" style=\"background-color:#edf7fb\">Ce dossier s\u2019inscrit dans le cadre du projet ANR I-BioLex \u00ab\u202fFragmentation et d\u00e9fragmentation du droit des innovations biom\u00e9dicales\u202f\u00bb (2021-2025) dont les objectifs consistent \u00e0 explorer et \u00e0 expliquer les processus de fragmentation et de d\u00e9fragmentation du droit et d\u2019en d\u00e9crypter les d\u00e9veloppements dans le temps dans le domaine du droit europ\u00e9en des innovations biom\u00e9dicales<a id=\"_ftnref13\" href=\"#_ftn13\"><sup>[13]<\/sup><\/a>. \u00c0 ces fins, le projet s\u2019appuie sur l\u2019\u00e9tat de l\u2019art dans trois domaines principaux qui nourrissent les r\u00e9flexions sur les d\u00e9finitions et concepts du biodroit contenues dans ce dossier.<br><br>En premier lieu, alors que l\u2019ensemble des travaux juridiques du domaine atteste des enjeux li\u00e9s \u00e0 l\u2019encadrement juridique des innovations biom\u00e9dicales ou biotechnologiques, ou de technologies de sant\u00e9 complexes<a id=\"_ftnref14\" href=\"#_ftn14\"><sup>[14]<\/sup><\/a>, deux tendances principales peuvent \u00eatre identifi\u00e9es. D\u2019une part, les innovations remettent en question les cadres juridiques existants<a id=\"_ftnref15\" href=\"#_ftn15\"><sup>[15]<\/sup><\/a>. D\u2019autre part, les innovations sont fa\u00e7onn\u00e9es par la mani\u00e8re dont le droit est construit et mis en \u0153uvre<a id=\"_ftnref16\" href=\"#_ftn16\"><sup>[16]<\/sup><\/a>. Alors que la plus grande partie de la litt\u00e9rature juridique rel\u00e8ve de la premi\u00e8re tendance, le projet I-BioLex embrasse ces deux tendances en prenant en compte ce double mouvement entre le droit et les innovations biom\u00e9dicales (connu sous le nom de \u00ab\u202fcoproduction\u202f\u00bb dans les \u00e9tudes socio-juridiques)<a id=\"_ftnref17\" href=\"#_ftn17\"><sup>[17]<\/sup><\/a> ainsi que le contexte dans lequel le droit est adopt\u00e9.<br><br>Dans le cadre de ce dossier, cela implique que les travaux r\u00e9alis\u00e9s portent sur des d\u00e9finitions juridiques et des concepts juridiques du biodroit qui sont non seulement remis en question par le d\u00e9veloppement des innovations biotechnologiques, mais qui ont \u00e9galement une influence sur celui-ci.<br><br>En deuxi\u00e8me lieu, la temporalit\u00e9 du droit positif est souvent remise en question par le d\u00e9veloppement des innovations biom\u00e9dicales ou biotechnologiques (soi-disant \u00ab\u202fretard du droit\u202f\u00bb)\u2009: la dur\u00e9e de cr\u00e9ation, d\u2019adoption et de mise en \u0153uvre du droit menant \u00e0 son obsolescence pr\u00e9coce pour l\u2019encadrement d\u2019innovations en perp\u00e9tuelle \u00e9volution. Alors que de nombreux auteurs d\u00e9fendent, en sciences juridiques, la position selon laquelle le droit doit suivre ou r\u00e9agir au d\u00e9veloppement de ces innovations<a id=\"_ftnref18\" href=\"#_ftn18\"><sup>[18]<\/sup><\/a>, d\u2019autres ont soulign\u00e9 le potentiel d\u2019anticipation du droit<a id=\"_ftnref19\" href=\"#_ftn19\"><sup>[19]<\/sup><\/a>. Le lien temporel entre la cr\u00e9ation, la mise en \u0153uvre et l\u2019\u00e9volution du droit et le d\u00e9veloppement des innovations biom\u00e9dicales est un autre aspect important du projet I-BioLex. Dans ce contexte, les d\u00e9finitions et concepts juridiques du biodroit peuvent \u00eatre consid\u00e9r\u00e9s comme r\u00e9v\u00e9lateurs des liens entre les objectifs d\u2019adaptabilit\u00e9 et de coh\u00e9rence du biodroit et ses fonctions de r\u00e9action, d\u2019anticipation ou d\u2019abstention au regard de l\u2019encadrement des innovations biom\u00e9dicales ou biotechnologiques.<br><br>En troisi\u00e8me et dernier lieu, le projet I-BioLex explore les processus de fragmentation et d\u00e9fragmentation du droit des innovations biom\u00e9dicales. Alors que le ph\u00e9nom\u00e8ne de fragmentation du droit est particuli\u00e8rement discut\u00e9 en droit international, principalement sous l\u2019angle des probl\u00e8mes qu\u2019il engendre<a id=\"_ftnref20\" href=\"#_ftn20\"><sup>[20]<\/sup><\/a>, le projet I-BioLex consid\u00e8re la fragmentation et la d\u00e9fragmentation comme des processus coexistant plut\u00f4t que comme des forces antagonistes. Les processus de fragmentation et de d\u00e9fragmentation sont ainsi consid\u00e9r\u00e9s soit comme des strat\u00e9gies juridiques pour r\u00e9pondre au d\u00e9veloppement des innovations biom\u00e9dicales, soit comme des r\u00e9ponses plus contingentes refl\u00e9tant l\u2019\u00e9volution des contextes politiques et juridiques. \u00c0 ce titre, ils r\u00e9v\u00e8lent la tension entre la volont\u00e9 de soutenir le d\u00e9veloppement d\u2019une innovation biom\u00e9dicale ou biotechnologique, notamment par l\u2019\u00e9tablissement de d\u00e9finitions et de concepts juridiques particuliers, et celle de ne pas entraver le d\u00e9veloppement d\u2019autres innovations via d\u2019autres d\u00e9finitions et concepts juridiques li\u00e9s \u00e0 des cat\u00e9gories juridiques, proc\u00e9dures ou r\u00e9gimes communs \u00e0 d\u2019autres objets du biodroit. \u00c9volution, compl\u00e9mentarit\u00e9, chevauchement, opposition, existence ou absence des d\u00e9finitions et concepts du biodroit participent ainsi \u00e0 la mise en \u0153uvre des processus de fragmentation et de d\u00e9fragmentation de ce droit.<\/p>\n\n\n\n<h2 class=\"wp-block-heading has-text-align-center has-medium-font-size\"><strong>III. Le contenu et l\u2019\u00e9volution de ce dossier<\/strong><\/h2>\n\n\n\n<p class=\"has-text-align-justify has-background\" style=\"background-color:#edf7fb\">Au-del\u00e0 des conventions de langage propos\u00e9es aux contributeurs, ce dossier est construit sur la base de trois orientations principales.<br><br>En premier lieu, le domaine est celui du biodroit, entendu au sens large, comme le droit relatif au biologique, qu\u2019il s\u2019agisse du mat\u00e9riel biologique humain, animal ou v\u00e9g\u00e9tal, que celui-ci soit r\u00e8glement\u00e9 en tant que tel ou transform\u00e9 en produit de sant\u00e9, innovation biom\u00e9dicale, ou plus largement innovation biotechnologique, au-del\u00e0 du champ m\u00e9dical. Les contributions ne sont donc pas limit\u00e9es au domaine m\u00e9dical ou \u00e0 celui de la sant\u00e9 m\u00eame si celui-ci reste majoritaire<a id=\"_ftnref21\" href=\"#_ftn21\"><sup>[21]<\/sup><\/a>, puisqu\u2019elles peuvent aussi \u00eatre associ\u00e9es au domaine de l\u2019environnement en particulier<a id=\"_ftnref22\" href=\"#_ftn22\"><sup>[22]<\/sup><\/a>. Dans tous les cas, elles rel\u00e8vent toutes de la r\u00e8glementation du domaine biologique.<br><br>En deuxi\u00e8me lieu, ce dossier entend couvrir plusieurs ordres juridiques, qu\u2019il s\u2019agisse des niveaux europ\u00e9ens ou internationaux, ou m\u00eame nationaux, l\u2019approche compar\u00e9e \u00e9tant favoris\u00e9e, sans \u00eatre impos\u00e9e. Ainsi, la plupart des contributions \u00e0 ce dossier couvrent le droit de l\u2019Union europ\u00e9enne<a id=\"_ftnref23\" href=\"#_ftn23\"><sup>[23]<\/sup><\/a>, mais certaines couvrent \u00e0 la fois le droit de l\u2019Union europ\u00e9enne et le droit issu du Conseil de l\u2019Europe<a id=\"_ftnref24\" href=\"#_ftn24\"><sup>[24]<\/sup><\/a>, et parfois m\u00eame aussi un droit national<a id=\"_ftnref25\" href=\"#_ftn25\"><sup>[25]<\/sup><\/a>, ou le droit de l\u2019Union europ\u00e9enne et celui issu du Conseil international d\u2019harmonisation des exigences techniques pour l\u2019enregistrement des m\u00e9dicaments \u00e0 usage humain (ICH)<a id=\"_ftnref26\" href=\"#_ftn26\"><sup>[26]<\/sup><\/a>.<br><br>En troisi\u00e8me lieu, ce dossier entend combiner des analyses de droit positif sur une ou plusieurs d\u00e9finitions ou concepts du biodroit<a id=\"_ftnref27\" href=\"#_ftn27\"><sup>[27]<\/sup><\/a>, et des analyses de la science du droit, plus transversales et relatives \u00e0 des r\u00e9flexions sur l\u2019ensemble ou plusieurs de ces d\u00e9finitions ou concepts<a id=\"_ftnref28\" href=\"#_ftn28\"><sup>[28]<\/sup><\/a>.<br><br>Par ailleurs, il convient de souligner que ce dossier pr\u00e9sente deux caract\u00e9ristiques.<br><br>D\u2019une part, les contributions sont soit en anglais soit en fran\u00e7ais, car les coordinateurs ont souhait\u00e9 regrouper des analyses provenant de plusieurs cultures juridiques sur le th\u00e8me de ce dossier. Si la plupart des juristes ayant initialement particip\u00e9 sont issus d\u2019une culture juridique continentale, l\u2019ouverture \u00e0 la langue anglaise a permis la contribution de chercheurs non issus de cette culture. Elle permet \u00e9galement, \u00e0 tout le moins, l\u2019extension des discussions futures au-del\u00e0 du monde francophone, celui-ci \u00e9tant fortement marqu\u00e9 par la place centrale de la \u00ab\u202fqualification\u202f\u00bb juridique, qui ne correspond qu\u2019imparfaitement \u00e0 l\u2019op\u00e9ration de \u00ab\u202fsubsomption\u202f\u00bb, terme de la traduction en anglais \u00e0 laquelle la qualification pourrait \u00eatre rattach\u00e9e.<br><br>D\u2019autre part, ce dossier est voulu dynamique. Il s\u2019agit ici de tenir compte du lien temporel particulier qui existe entre le droit et les innovations biom\u00e9dicales ou biotechnologiques, ou plus largement le biodroit, comme expliqu\u00e9 ci-dessus. \u00c0 ce titre, la publication en ligne et en libre acc\u00e8s permise par <em>Confluence des droits_La&nbsp;Revue<\/em> offre la possibilit\u00e9 d\u2019un enrichissement de ce dossier au gr\u00e9 de la communaut\u00e9 des sciences juridiques, ou m\u00eame plus largement de celles des \u00e9tudes en science et technologie. Les discussions sur les d\u00e9finitions et concepts juridiques du biodroit sont en effet initi\u00e9es et regroup\u00e9es au sein de ce dossier, mais ce dernier est destin\u00e9 \u00e0 \u00eatre compl\u00e9t\u00e9 et \u00e0 \u00e9voluer dans un espace accessible \u00e0 tous.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<p><a id=\"_ftn1\" href=\"#_ftnref1\"><sup>[1]<\/sup><\/a> Voir notamment, pour quelques illustrations particuli\u00e8res\u2009: L.-M. Schmit, <em><a href=\"https:\/\/books.openedition.org\/putc\/2335\"><u>Les d\u00e9finitions en droit priv\u00e9<\/u><\/a><\/em>, Presses de l\u2019Universit\u00e9 Toulouse Capitole, Librairie g\u00e9n\u00e9rale de droit et de jurisprudence, 2017\u2009; D. Truchet, \u00ab\u202fLes d\u00e9finitions l\u00e9gislatives\u202f\u00bb, in R. Drago (dir.), <em>La confection de la loi<\/em>, PUF, 2005, p. 193\u2009; C.\u202fEiseinmann, \u00ab\u202fQuelques probl\u00e8mes de m\u00e9thodologie des d\u00e9finitions et des classifications en science juridique\u202f\u00bb, <em>APD<\/em>, 1966, p.&nbsp;25-43\u2009; C.\u202fWolmark, <em>La d\u00e9finition pr\u00e9torienne. \u00c9tude en droit du travail<\/em>, Th\u00e8se, Univ. Paris 10, Dalloz, coll. Nouvelle biblioth\u00e8que de th\u00e8ses, 2007\u2009; A. Rey, \u00ab\u202fPolys\u00e9mie du terme d\u00e9finition\u202f\u00bb, in <em>La d\u00e9finition<\/em>, Colloque du Centre d\u2019\u00e9tude du lexique, Larousse, coll. Langue et Langage, 1990.<\/p>\n\n\n\n<p><a href=\"#_ftnref2\" id=\"_ftn2\"><sup>[2]<\/sup><\/a> \u00c0 titre d\u2019exception, on mentionnera en particulier\u2009: M. Glinel, <em>Qualification juridique et d\u00e9limitation des comp\u00e9tences normatives de l\u2019Union europ\u00e9enne\u2009: l\u2019exemple des biotechnologies<\/em>, Th\u00e8se Droit, Universit\u00e9 Toulouse Capitole, 2023.<\/p>\n\n\n\n<p><a id=\"_ftn3\" href=\"#_ftnref3\"><sup>[3]<\/sup><\/a> Nous reprenons ici une distinction, le triangle conceptuel, g\u00e9n\u00e9ralement attribu\u00e9e \u00e0 C. K. Ogden et I.&nbsp;A.&nbsp;Richards, <em>The Meaning of Meaning<\/em>, Hartcourt, Brace &amp; World, 1923.<\/p>\n\n\n\n<p><a href=\"#_ftnref4\" id=\"_ftn4\"><sup>[4]<\/sup><\/a> Article 1, Directive 2001\/83\/CE du Parlement europ\u00e9en et du Conseil du 6 novembre 2001 instituant un code communautaire relatif aux m\u00e9dicaments \u00e0 usage humain, <em>JO L<\/em> 311 du 28.11.2001, p. 67\u2013128.<\/p>\n\n\n\n<p><a href=\"#_ftnref5\" id=\"_ftn5\"><sup>[5]<\/sup><\/a> Article 4, Proposition de directive du Parlement europ\u00e9en et du Conseil instituant un code de l\u2019Union relatif aux m\u00e9dicaments \u00e0 usage humain et abrogeant la directive 2001\/83\/CE et la directive 2009\/35\/CE, 26.04.2023, COM(2023)192 final.<\/p>\n\n\n\n<p><a href=\"#_ftnref6\" id=\"_ftn6\"><sup>[6]<\/sup><\/a> <em>EMA, Guideline on clinical evaluation of vaccines<\/em>, 16 January 2023, EMEA\/CHMP\/VWP\/164653\/05 Rev. 1.<\/p>\n\n\n\n<p><a href=\"#_ftnref7\" id=\"_ftn7\"><sup>[7]<\/sup><\/a> Article 4(11), Proposition de directive, COM(2023)192 final, <em>op. cit<\/em>.<\/p>\n\n\n\n<p><a href=\"#_ftnref8\" id=\"_ftn8\"><sup>[8]<\/sup><\/a> R\u00e8glement (UE) 2024\/1938 du Parlement europ\u00e9en et du Conseil du 13 juin 2024 concernant les normes de qualit\u00e9 et de s\u00e9curit\u00e9 des substances d\u2019origine humaine destin\u00e9es \u00e0 une application humaine et abrogeant les directives 2002\/98\/CE et 2004\/23\/CE, <em>JO L<\/em>, 2024\/1938, 17.7.2024.<\/p>\n\n\n\n<p><a href=\"#_ftnref9\" id=\"_ftn9\"><sup>[9]<\/sup><\/a> Par exemple, \u00ab\u202fAucun m\u00e9dicament ne peut \u00eatre mis sur le march\u00e9 d&rsquo;un \u00c9tat membre sans qu&rsquo;une autorisation de mise sur le march\u00e9 n&rsquo;ait \u00e9t\u00e9 d\u00e9livr\u00e9e par l&rsquo;autorit\u00e9 comp\u00e9tente de cet \u00c9tat membre\u202f\u00bb, Article 6(1), Directive 2001\/83\/CE, <em>op.<\/em><em>&nbsp;<\/em><em>cit.<\/em><\/p>\n\n\n\n<p><a id=\"_ftn10\" href=\"#_ftnref10\"><sup>[10]<\/sup><\/a> Par exemple, sur le m\u00eame sujet\u2009: \u00ab\u202fThe obligation to secure a marketing authorisation, warranting safety and efficacy of medicines, was introduced for all medicines marketed within the then European Economic Community (EEC), setting in motion the EU\u2019s precautionary approach to risk of harm from medicines\u202f\u00bb. T.&nbsp;K.&nbsp;Hervey, \u201cHealth law\u201d, in S. Garben, L. Gormley, <em>The Oxford Encylopedia of EU Law [OEEUL]<\/em>, June 2022.<\/p>\n\n\n\n<p><a id=\"_ftn11\" href=\"#_ftnref11\"><sup>[11]<\/sup><\/a> \u00ab\u202fUn type de SoHO qui\u2009: a) a \u00e9t\u00e9 soumis \u00e0 une transformation et, le cas \u00e9ch\u00e9ant, \u00e0 une ou plusieurs autres activit\u00e9s SoHO vis\u00e9es \u00e0 l\u2019article&nbsp;2, paragraphe 1, point c); b) a une indication clinique sp\u00e9cifique; et&nbsp;c) est destin\u00e9 \u00e0 une application humaine \u00e0 un receveur de SoHO ou est destin\u00e9 \u00e0 \u00eatre distribu\u00e9\u202f\u00bb. Article 3(37) du R\u00e8glement SoHO, <em>op. cit.<\/em><\/p>\n\n\n\n<p><a href=\"#_ftnref12\" id=\"_ftn12\"><sup>[12]<\/sup><\/a> \u00ab\u202f\u201ctransformation\u201d\u2009: toute op\u00e9ration intervenant dans le traitement des SoHO, y compris, mais sans s\u2019y limiter, le lavage, la mise en forme, la s\u00e9paration, la d\u00e9contamination, la st\u00e9rilisation, le stockage et le conditionnement, \u00e0&nbsp;l\u2019exception du traitement pr\u00e9paratoire de SoHO en vue d\u2019une application humaine imm\u00e9diate lors d\u2019une intervention chirurgicale, sans que les SoHO soient retir\u00e9es du champ chirurgical avant leur application\u202f\u00bb. Article 3(23) du R\u00e8glement SoHO, <em>op. cit.<\/em><\/p>\n\n\n\n<p><a href=\"#_ftnref13\" id=\"_ftn13\"><sup>[13]<\/sup><\/a> Pour plus d\u2019informations sur ce projet, voir <a href=\"https:\/\/elsibi.hypotheses.org\/i-biolex\"><u>le site internet du projet<\/u><\/a> (dernier acc\u00e8s le 03\/11\/2024).<\/p>\n\n\n\n<p><a href=\"#_ftnref14\" id=\"_ftn14\"><sup>[14]<\/sup><\/a> <em>En ce sens, voir notamment<\/em><em>\u2009<\/em><em>:<\/em><em> M. Flear, A.-M. Farrell, T. Hervey, T. Murphy, European Law and New Health Technologies,<\/em> Oxford University Press, Oxford 2013, 477 p.<\/p>\n\n\n\n<p><a id=\"_ftn15\" href=\"#_ftnref15\"><sup>[15]<\/sup><\/a> En ce sens, voir notamment\u2009: A. Mahalatchimy, E. Rial-Sebbag (dir.), <em>L\u2019Humain m\u00e9dicament<\/em>, <em>Quaderni<\/em> n\u00b0&nbsp;81, printemps 2013, \u00c9ditions de la Maison des sciences de l&rsquo;homme Paris, 194 p.<\/p>\n\n\n\n<p><a id=\"_ftn16\" href=\"#_ftnref16\"><sup>[16]<\/sup><\/a> En ce sens, voir notamment\u2009: C.\u202fChabannon <em>et al.<\/em>, \u00ab\u202fLes unit\u00e9s de th\u00e9rapie cellulaire \u00e0 l\u2019\u00e9preuve de la r\u00e8glementation sur les m\u00e9dicaments de th\u00e9rapie innovante\u202f\u00bb, <em>M\u00e9decine\/Sciences<\/em>, mai 2014, 30 (5), <br>p.&nbsp;576- 583.<\/p>\n\n\n\n<p><a href=\"#_ftnref17\" id=\"_ftn17\"><sup>[17]<\/sup><\/a> <em>S. Jasanoff, States of knowledge\u2009: the co- production of knowledge and social order<\/em>, Routledge 2004.<\/p>\n\n\n\n<p><a href=\"#_ftnref18\" id=\"_ftn18\"><sup>[18]<\/sup><\/a> R. Brownsword, K. Yeung, <em>Regulating Technologies: Legal futures, regulatory frames and technological fixes<\/em>, Hart Publishing, 2008, p. 3-22.<\/p>\n\n\n\n<p><a href=\"#_ftnref19\" id=\"_ftn19\"><sup>[19]<\/sup><\/a> A. Faulkner, <em>Regulatory policy as innovation: constructing rules of engagement of a technological zone for tissue engineering in the European Union<\/em>, Research Policy, 2009, 38, p.&nbsp;596- 615.<\/p>\n\n\n\n<p><a href=\"#_ftnref20\" id=\"_ftn20\"><sup>[20]<\/sup><\/a> A.-C. Martineau, <em>Le d\u00e9bat sur la fragmentation du droit international \u2013 Une analyse critique<\/em>, Bruylant, 2015.<\/p>\n\n\n\n<p><a id=\"_ftn21\" href=\"#_ftnref21\"><sup>[21]<\/sup><\/a> Il s\u2019agit ici des contributions de <a href=\"https:\/\/confluencedesdroits-larevue.com\/?p=4180\" class=\"ek-link\">Matthieu Guerriaud<\/a>\u2009; <a href=\"https:\/\/confluencedesdroits-larevue.com\/?p=4183\" class=\"ek-link\">Katrina Peherudoff et Elena Pires<\/a>\u2009; <a href=\"https:\/\/confluencedesdroits-larevue.com\/?p=4176\" class=\"ek-link\">Audrey&nbsp;Lebret<\/a>\u2009; <a href=\"https:\/\/confluencedesdroits-larevue.com\/?p=4182\" class=\"ek-link\">Gauthier Chassang, Lisa Feriol et No\u00e9mie Dubruel<\/a>\u2009; <a href=\"https:\/\/confluencedesdroits-larevue.com\/?p=4178\" class=\"ek-link\">Adrien Bottacci<\/a>\u2009; <a href=\"https:\/\/confluencedesdroits-larevue.com\/?p=4181\" class=\"ek-link\">\u00c9lo\u00efse Gennet et Aur\u00e9lie Mahalatchimy<\/a>.<\/p>\n\n\n\n<p><a id=\"_ftn22\" href=\"#_ftnref22\"><sup>[22]<\/sup><\/a> En ce sens, voir les contributions d\u2019<a href=\"https:\/\/confluencedesdroits-larevue.com\/?p=4179\" class=\"ek-link\">Estelle Brosset<\/a> et de <a href=\"https:\/\/confluencedesdroits-larevue.com\/?p=4177\" class=\"ek-link\">Valentine Delcroix<\/a>.<\/p>\n\n\n\n<p><a id=\"_ftn23\" href=\"#_ftnref23\"><sup>[23]<\/sup><\/a> En ce sens, voir les contributions d\u2019<a href=\"https:\/\/confluencedesdroits-larevue.com\/?p=4179\" class=\"ek-link\">Estelle Brosset<\/a>\u2009; <a href=\"https:\/\/confluencedesdroits-larevue.com\/?p=4177\" class=\"ek-link\">Valentine Delcroix<\/a>\u2009; <a href=\"https:\/\/confluencedesdroits-larevue.com\/?p=4183\" class=\"ek-link\">Katrina Peherudoff et Elena Pires<\/a>\u2009; <a href=\"https:\/\/confluencedesdroits-larevue.com\/?p=4181\" class=\"ek-link\">\u00c9lo\u00efse Gennet et Aur\u00e9lie Mahalatchimy<\/a>.<\/p>\n\n\n\n<p><a id=\"_ftn24\" href=\"#_ftnref24\"><sup>[24]<\/sup><\/a> En ce sens, voir les contributions d\u2019<a href=\"https:\/\/confluencedesdroits-larevue.com\/?p=4176\" class=\"ek-link\">Audrey Lebret,<\/a> <a href=\"https:\/\/confluencedesdroits-larevue.com\/?p=4182\" class=\"ek-link\">Gauthier Chassang, Lisa Feriol et No\u00e9mie&nbsp;Dubruel<\/a>.<\/p>\n\n\n\n<p><a id=\"_ftn25\" href=\"#_ftnref25\"><sup>[25]<\/sup><\/a> En ce sens, voir les contributions de <a href=\"https:\/\/confluencedesdroits-larevue.com\/?p=4184\" class=\"ek-link\">Xavier Bioy<\/a> et d\u2019<a href=\"https:\/\/confluencedesdroits-larevue.com\/?p=4178\" class=\"ek-link\">Adrien Bottacci<\/a>.<\/p>\n\n\n\n<p><a id=\"_ftn26\" href=\"#_ftnref26\"><sup>[26]<\/sup><\/a> En ce sens, voir la contribution de <a href=\"https:\/\/confluencedesdroits-larevue.com\/?p=4180\" class=\"ek-link\">Matthieu Guerriaud<\/a>.<\/p>\n\n\n\n<p><a href=\"#_ftnref27\" id=\"_ftn27\"><sup>[27]<\/sup><\/a> Ainsi en est-il des contributions relatives aux substances d\u2019origine humaine, \u00e0 la substance, aux organo\u00efdes, aux m\u00e9dicaments de th\u00e9rapie g\u00e9nique, aux innovations biom\u00e9dicales, aux organismes g\u00e9n\u00e9tiquement modifi\u00e9s, mais aussi \u00e0 l\u2019esp\u00e8ce humaine, la vie priv\u00e9e, ou aux besoins m\u00e9dicaux non satisfaits.<\/p>\n\n\n\n<p><a href=\"#_ftnref28\" id=\"_ftn28\"><sup>[28]<\/sup><\/a> Concernant cette approche, voir la contribution de Marie Glinel et la synth\u00e8se de Xavier Magnon.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<div class=\"wp-block-file\"><a id=\"wp-block-file--media-8e40260e-a381-47c9-be80-cbc8c8e3a0fc\" href=\"https:\/\/confluencedesdroits-larevue.com\/wp-content\/uploads\/2025\/07\/Pourquoi-un-dossier-sur-les-definitions-et-les-concepts-du-biodroit_A.-Mahalatchimy_X.-Magnon_M.-Glinel-07-25.pdf\">Pourquoi-un-dossier-sur-les-definitions-et-les-concepts-du-biodroit_A.-Mahalatchimy_X.-Magnon_M.-Glinel-07-25<\/a><a href=\"https:\/\/confluencedesdroits-larevue.com\/wp-content\/uploads\/2025\/07\/Pourquoi-un-dossier-sur-les-definitions-et-les-concepts-du-biodroit_A.-Mahalatchimy_X.-Magnon_M.-Glinel-07-25.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-8e40260e-a381-47c9-be80-cbc8c8e3a0fc\"><\/a><\/div>\n\n\n\n<p class=\"has-text-align-justify has-background\" style=\"background-color:#ededed\">Aur\u00e9lie Mahalatchimy, Xavier Magnon, Marie Glinel, \u00ab&nbsp;Pourquoi un dossier sur les d\u00e9finitions et les concepts du biodroit\u2009?&nbsp;\u00bb, D\u00e9finitions et concepts du biodroit [Dossier], <em>Confluence des droits_La&nbsp;revue <\/em>[En&nbsp;ligne], 07&nbsp;|&nbsp;2025, mis&nbsp;en ligne le 7 juillet 2025. URL : <a href=\"https:\/\/confluencedesdroits-larevue.com\/?p=4175\" class=\"ek-link\"><u>https:\/\/confluencedesdroits-larevue.com\/?p=<\/u>4175<\/a>.<\/p>\n\n<\/div>\n\n<div class=\"\"  data-pds-tabs--accordion-initially-open=\"false\" >\n\n<div class=\"wp-block-file\"><a id=\"wp-block-file--media-5eb6d5b1-09cf-405e-8b02-59f88f274fd7\" href=\"https:\/\/confluencedesdroits-larevue.com\/wp-content\/uploads\/2025\/07\/Why-a-special-issue-on-definitions-and-concepts-in-biolaw_A.-Mahalatchimy_X.-Magnon_M.-Glinel-07-25.pdf\">Why-a-special-issue-on-definitions-and-concepts-in-biolaw_A.-Mahalatchimy_X.-Magnon_M.-Glinel-07-25<\/a><a href=\"https:\/\/confluencedesdroits-larevue.com\/wp-content\/uploads\/2025\/07\/Why-a-special-issue-on-definitions-and-concepts-in-biolaw_A.-Mahalatchimy_X.-Magnon_M.-Glinel-07-25.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-5eb6d5b1-09cf-405e-8b02-59f88f274fd7\"><\/a><\/div>\n\n\n\n<div style=\"height:50px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p><em>The authors deeply thank Professor Tamara K. Hervey for her useful comments on a previous version of this paper. The authors also thank Victoria Burakova-Lorgnier for her helpful support in the translation of this paper from French to English.<\/em><\/p>\n\n\n\n<div style=\"height:50px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading\" style=\"font-size:30px\"><strong>Why a special issue on definitions and&nbsp;concepts in&nbsp;biolaw?<\/strong><\/h2>\n\n\n\n<p class=\"has-text-align-justify has-background\" style=\"background-color:#edf7fb\">Concepts and definitions play a central role in law as they allow, respectively, to name and describe, as well as delimit a real or fictional entity, and ensure a common understanding of it, with a view to legally qualifying it in order to associate it with a legal regime. By focusing on the conceptual dimension, we intend to go beyond an approach based purely on notions. As far as possible, the discussion will focus on concepts, rather than notions, the latter being regarded here as a necessary preliminary step to any reflection on the former. We offer to consider that a notional analysis entails the identification of all criteria that may be used to recognize an element of reality, in an exhaustive manner, by identifying and examining each criterion, without necessarily determining their relative relevance for identifying that reality. In contrast, a conceptual analysis requires selecting only those criteria that are relevant for identifying the element of reality, and assigning to each selected criterion its proper weight and position in order to reveal the typical features of the object described. For the science of law\u2014as a scholarly discourse on law\u2014the act of conceptualization lies at the core of the scientific approach. Numerous studies in legal theory, or more broadly in fundamental legal research, have addressed this&nbsp;topic.<a id=\"_ftnref1\" href=\"#_ftn1\"><sup>[1]<\/sup><\/a><br><br>In the field of biolaw\u2014understood here as the body of legal norms and legal questions pertaining to the biological domain and\/or arising from technological advances in biomedicine, and more broadly in biotechnology\u2014definitions and concepts present particular challenges that have rarely been addressed directly and transversally within legal scholarship.<a id=\"_ftnref2\" href=\"#_ftn2\"><sup>[2]<\/sup><\/a> Yet, definitions and concepts are of critical importance in this area, given the continuously evolving and unpredictable nature of scientific practices, and the absence of consensus around many scientific definitions. The establishment of definitions thus constitutes a fundamental concern for biolaw, as it enables the law to apprehend and orient such practices in a coherent and effective manner. While biolaw may itself be approached as a concept within the science of law, it is considered here, first and foremost, as a domain of legal inquiry, forming the subject matter of the present study. Nevertheless, the scholarly work produced within this domain contributes to the conceptual framing of biolaw, whose usage\u2014as a doctrinal category\u2014would benefit from greater consistency and theoretical refinement.<br><br>This thematic raises a series of concrete and pressing legal questions: Can legislation or regulation meaningfully define emerging innovations in biomedicine or biotechnology while these developments remain in flux, or in fields characterized by scientific and technological uncertainty? To what extent may legal or regulatory definitions diverge from those adopted by the scientific community, and under what conditions is such divergence justified? What normative legitimacy does the legal scholar or legislator possess in departing from scientific definitions? Is it preferable, in certain contexts, to refrain from defining a given object of regulation, due to the inherent difficulties in tracking developments within dynamic and highly technical fields? Under what circumstances, and for what reasons, have legislators or regulatory authorities chosen to define\u2014or to abstain from defining\u2014biomedical innovations or biotechnologies? When and why has the law opted to regulate on the basis of the <em>intended use<\/em> of a given technology rather than the <em>intrinsic nature<\/em> of the object itself?<br><br>While legal literature generally focuses on the legal or regulatory frameworks to be adopted and on the challenges posed to such regulation by biomedical and biotechnological innovations, this special issue focuses instead on how legislation\u2014or regulation more broadly\u2014defines or fails to define these innovations, and on the consequences that definitions and concepts may have for their development.<\/p>\n\n\n\n<h1 class=\"wp-block-heading has-text-align-center has-medium-font-size\"><strong>I. Language Conventions: \u201cConcept\u201d and \u201cDefinition\u201d<\/strong><\/h1>\n\n\n\n<p class=\"has-text-align-justify has-background\" style=\"background-color:#edf7fb\">In order to structure discussions and understanding in the use of the terms \u201cconcept\u201d and \u201cdefinition\u201d, we suggest that authors retain certain conventions of language around the meaning and uses of these terms in this special issue.<br><br>Thus, we suggest to call:<\/p>\n\n\n\n<ul>\n<li><em>name<\/em> of the concept, the designation given to the concept,<\/li>\n\n\n\n<li><em>definition<\/em> of the concept, the proposition formed by a linguistic statement aimed at identifying a given reality (which comes under the name of the concept) on the basis of its typicality,<\/li>\n\n\n\n<li>the <em>extension<\/em> of the concept, all the situations covered by the concept, which it can be used to qualify.<a id=\"_ftnref3\" href=\"#_ftn3\"><sup>[3]<\/sup><\/a><\/li>\n<\/ul>\n\n\n\n<p class=\"has-text-align-justify has-background\" style=\"background-color:#edf7fb\">For instance, \u201cChair\u201d is the name of the concept used to describe \u201ca piece of furniture with backrest and no arms that is designed for one person to sit\u201d, which is the definition of the concept. All the pieces of furniture with backrest and no arms that are designed for one person to sit are extensions of the concept (they are chairs). In a statement referring to a concept, it is possible to identify the concept in its three dimensions: its name, its definition or its extension.<br><br>The statement \u201cI sat on a chair\u201d uses the name of the concept, the statement \u201cI sat on a piece of furniture with backrest and no arms that is designed for one person to sit\u201d, its definition, and the statement \u201cI sat on the dining room chair\u201d, an extension of the concept. Language can perfectly well use the name of the concept, its definition or its extension separately, even if, in our example, the proposition that constitutes the extension of the concept uses its name (\u201cthe chair in the dining room\u201d is a \u201cchair\u201d, so the term \u201cchair\u201d is used to designate it).<br><br>Law, insofar as it is formulated on the basis of linguistic statements, can therefore either use the name of a concept, define it or extend it. Indeed, while applicable law often defines the concepts it uses as a fundamental method to determine the scope of legal rights and obligations it establishes, it is also full of concepts that are named without being defined. In that context, European Union (EU) law is a good example of the efforts made to define various legal concepts in a dedicated article at the beginning of directives and regulations although one can wonder about the definitions of those that are named without being defined. For instance, in the field of biolaw where the EU medicines legislation may apply, the proposal of reform of the pharmaceutical legislation is significantly showing the efforts made to define concepts and make them accessible in increasing the number of definitions available from 33 in the current community code<a id=\"_ftnref4\" href=\"#_ftn4\"><sup>[4]<\/sup><\/a> to 70&nbsp;definitions in its proposed revision.<a id=\"_ftnref5\" href=\"#_ftn5\"><sup>[5]<\/sup><\/a> Some of these definitions already exist but are scattered in various other law texts including guidelines such as \u2018vaccines\u2019,<a id=\"_ftnref6\" href=\"#_ftn6\"><sup>[6]<\/sup><\/a> while other are currently being named without being defined such as \u2018non-clinical\u2019. Nevertheless, it should be highlighted that the proposed reform of pharmaceutical legislation provides for a definition of this latter term.<a id=\"_ftnref7\" href=\"#_ftn7\"><sup>[7]<\/sup><\/a> In contrast to the proposed reform of pharmaceutical legislation, Regulation (EU) 2024\/1938 on quality and safety standards for substances of human origin intended for human application (hereinafter the \u201cSoHO Regulation\u201d)<a id=\"_ftnref8\" href=\"#_ftn8\"><sup>[8]<\/sup><\/a> will eliminate the existing legal definitions of blood, cells, and tissues, in favor of a new legal concept: \u201csubstances of human origin.\u201d<br><br>Thus, Article 3(1) of the SoHO Regulation provides: \u201cFor the purposes of this Regulation, the following definitions apply: \u2018substance of human origin\u2019 or \u2018SoHO\u2019 means any substance collected from the human body, whether it contains cells or not and whether those cells are living or not, including SoHO preparations resulting from the processing of such substance.\u201d The provision thereby introduces the name of the concept with the legal term \u201csubstance of human origin\u201d while also providing its definition. As to the extension of the concept, any substance retrieved from the human body\u2014regardless of whether it contains cells, and whether those cells are living or not\u2014may fall within the definition of a \u201csubstance of human origin.\u201d This would encompass, for example, blood and its components, cells, tissues, microbiota, human-origin urine or feces, and breast milk.<br><br>With this clarification, there are several types of statements that can mobilise each of the elements of the concept. Statements <em>of<\/em> the law, which are directly stated in a legal text<a id=\"_ftnref9\" href=\"#_ftn9\"><sup>[9]<\/sup><\/a> have to be distinguished from statements <em>about<\/em> the law. The latter comes from a discourse about the law.<a id=\"_ftnref10\" href=\"#_ftn10\"><sup>[10]<\/sup><\/a> Hence, we suggest that when the concept is <em>in<\/em> the law (when the law uses the word designating\u2014or naming\u2014the concept, when it defines or extends the concept), it is a <em>legal concept<\/em>. If the concept is in statements <em>about<\/em> the law, or at least in scholarly discourse on the law, we suggest to say that it is a <em>concept of the science of law<\/em>. This is the case, for example, with the concept of \u2018biomedical innovation\u2019, used in the ANR funded I-BioLex project mentioned below. The term is not used by positive law but by the science of law.<br><br>Given the subject of this special issue, our scholarly discussions will also include other discourses that may mobilise concepts in their three dimensions. In particular, we will use general scientific discourses, not only those of the science of law. Here, we suggest to write <em>scientific concept<\/em> to refer as a qualifier that may be applied according to discipline (scientific discourse in medicine (medical concept), philosophy (philosophical concept), sociology (sociological concept), etc.). On the other hand, discourse that can be described as common (that uses the common and\/or intuitive sense of a given reality, and that is not based on any scientific approach) will be described as a <em>common concept<\/em>.<br><br>Thus, a concept, in its <em>name<\/em>, <em>definition<\/em> or <em>extension<\/em>, may be qualified as:<\/p>\n\n\n\n<ul>\n<li><em>a legal concept<\/em> if it is contained in provisions of positive law (an applicable legal text whatever its source or status is (Act, Decree, Decision of a court.&nbsp;.&nbsp;.) at a given time in a given legal order);<\/li>\n\n\n\n<li><em>a concept of the science of law<\/em> when it is used in scholarly discourse on the law;<\/li>\n\n\n\n<li><em>a scientific concept<\/em> (of philosophy, medicine, sociology, etc.) when it is used by a scientific discourse other than legal discourse;<\/li>\n\n\n\n<li><em>a common concept<\/em> when the known dimensions (name, definition and\/or extension) of this concept are based on common, non-scientific elements.<\/li>\n<\/ul>\n\n\n\n<p class=\"has-text-align-justify has-background\" style=\"background-color:#edf7fb\">Legal concepts can draw upon scientific concepts, common concepts, and concepts from the science of law<strong>.<\/strong> For instance, the legal concept of \u201csubstance of human origin\u201d incorporates not only other legal concepts such as \u201cSoHO preparations\u201d<a href=\"#_ftn11\" id=\"_ftnref11\"><sup>[11]<\/sup><\/a> and \u201cprocessing\u201d<a href=\"#_ftn12\" id=\"_ftnref12\"><sup>[12]<\/sup><\/a> which will thus become concepts within the science of law, but also scientific concepts such as \u201cliving or non-living cells\u201d and the common concept of \u201chuman body\u201d.<\/p>\n\n\n\n<h1 class=\"wp-block-heading has-text-align-center has-medium-font-size\"><strong>II. Context: A special issue within the I-BioLex Project<\/strong><\/h1>\n\n\n\n<p class=\"has-text-align-justify has-background\" style=\"background-color:#edf7fb\">This special issue is part of the ANR funded I-BioLex research project titled \u201cFragmentation and Defragmentation of the Law of Biomedical Innovations\u201d (2021-2025), which aims to explore and explain the processes of fragmentation and defragmentation of law, as well as to analyze their developments over time within the field of European law concerning biomedical innovations.<a id=\"_ftnref13\" href=\"#_ftn13\"><sup>[13]<\/sup><\/a> To this end, the project draws on the state of the art in three main areas that inform the discussions on the definitions and concepts of biolaw contained in this special issue.<br><br>First, while much of the legal scholarship in this domain highlights the issues related to the legal regulation of biomedical or biotechnological innovations, or complex health technologies,<a id=\"_ftnref14\" href=\"#_ftn14\"><sup>[14]<\/sup><\/a> two main trends can be identified. On the one hand, innovations challenge existing legal frameworks.<a id=\"_ftnref15\" href=\"#_ftn15\"><sup>[15]<\/sup><\/a> On the other hand, innovations are shaped by the way in which law is constructed and implemented.<a id=\"_ftnref16\" href=\"#_ftn16\"><sup>[16]<\/sup><\/a> While the majority of legal literature aligns with the first trend, the I-BioLex project embraces both trends by considering this dual movement between law and biomedical innovations (known as \u201cco-production\u201d in socio-legal studies),<a id=\"_ftnref17\" href=\"#_ftn17\"><sup>[17]<\/sup><\/a> as well as the context in which the law is adopted. Regarding this special issue, this means that the work undertaken addresses legal definitions and concepts in biolaw that are not only questioned by the development of biotechnological innovations but also exert an influence on these very innovations.<br><br>Second, the temporality of positive law is frequently called into question by the pace of biomedical or biotechnological innovations (often referred to as the so-called \u201claw lag\u201d): the time required for the creation, adoption, and implementation of legal norms may lead to their early obsolescence in regulating constantly evolving innovations. While many scholars in legal science argue that the law must follow or respond to the development of such innovations,<a id=\"_ftnref18\" href=\"#_ftn18\"><sup>[18]<\/sup><\/a> others have highlighted the anticipatory potential of law.<a id=\"_ftnref19\" href=\"#_ftn19\"><sup>[19]<\/sup><\/a> The temporal relationship between the creation, implementation, and evolution of legal norms and the development of biomedical innovations constitutes another key dimension of the I-BioLex project. In this context, legal definitions and concepts in biolaw may be understood as indicators of the relationship between the objectives of adaptability and coherence in biolaw, and its regulatory functions\u2014whether reactive, anticipatory, or abstentionist\u2014in the governance of biomedical or biotechnological innovations.<br><br>Third and finally, the I-BioLex project explores the processes of fragmentation and defragmentation in the law governing biomedical innovations. While the phenomenon of legal fragmentation has been widely discussed in international law\u2014primarily from the perspective of the problems it generates<a id=\"_ftnref20\" href=\"#_ftn20\"><sup>[20]<\/sup><\/a>\u2014the I-BioLex project approaches fragmentation and defragmentation as co-existing processes, rather than as antagonistic forces. These processes are thus understood either as legal strategies employed in response to the development of biomedical innovations, or as contingent responses reflecting shifts in political and legal contexts. In this respect, they reveal a fundamental tension between, on the one hand, the objective of supporting the development of a particular biomedical or biotechnological innovation\u2014often through the creation of specific legal definitions and concepts\u2014and, on the other, the desire not to hinder the development of other innovations by maintaining alternative definitions and legal concepts tied to broader legal categories, procedures, or regulatory regimes applicable to other biolaw-related objects. The evolution, complementarity, overlap, opposition, presence, or absence of legal definitions and concepts within biolaw thus contribute directly to the implementation of fragmentation and defragmentation processes in this area of law.<\/p>\n\n\n\n<h1 class=\"wp-block-heading has-text-align-center has-medium-font-size\"><strong>III. Content and Development of this special issue<\/strong><\/h1>\n\n\n\n<p class=\"has-text-align-justify has-background\" style=\"background-color:#edf7fb\">Beyond the language conventions suggested to contributors, this special issue is structured around three main orientations.<br><br>First, the domain in question is that of biolaw, understood in a broad sense as the body of law relating to the biological realm\u2014whether concerning human, animal, or plant biological material\u2014whether regulated in its natural state or transformed into a health product, a biomedical innovation, or, more broadly, a biotechnological innovation extending beyond the medical field. Contributions are therefore not limited to the medical or health sectors, even if those remain predominant;<a id=\"_ftnref21\" href=\"#_ftn21\"><sup>[21]<\/sup><\/a> they may also pertain to other areas, notably environmental law,<a id=\"_ftnref22\" href=\"#_ftn22\"><sup>[22]<\/sup><\/a> insofar as they fall within the regulatory governance of the biological domain.<br><br>Second, the dossier seeks to engage with multiple legal orders, whether European, international, or national levels, with a preference\u2014though not a requirement\u2014for comparative approaches. Accordingly, while most contributions address European Union law,<a id=\"_ftnref23\" href=\"#_ftn23\"><sup>[23]<\/sup><\/a> some extend to cover both EU law and that of the Council of Europe,<a id=\"_ftnref24\" href=\"#_ftn24\"><sup>[24]<\/sup><\/a> and in some cases also integrate national legal frameworks,<a id=\"_ftnref25\" href=\"#_ftn25\"><sup>[25]<\/sup><\/a> or examine EU law alongside the legal standards developed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).<a id=\"_ftnref26\" href=\"#_ftn26\"><sup>[26]<\/sup><\/a><br><br>Third, this special issue aims to combine positive legal analyses focused on one or more definitions or concepts in biolaw<a id=\"_ftnref27\" href=\"#_ftn27\"><sup>[27]<\/sup><\/a> with more cross-cutting analyses stemming from the science of law, addressing broader reflections on several or all of these definitions and concepts.<a id=\"_ftnref28\" href=\"#_ftn28\"><sup>[28]<\/sup><\/a><br><br>In addition, two key features characterize this special issue.<br><br>First, the contributions are published in either English or French, as the editors deliberately sought to gather analyses from a diversity of legal cultures on the special issue\u2019s central theme. While most of the legal scholars involved at the project\u2019s inception come from a continental legal tradition, the use of English has opened the door to contributions from researchers outside that tradition. It also facilitates, at the very least, the expansion of future discussions beyond the Francophone world, where legal discourse is particularly shaped by the centrality of the concept of <em>qualification<\/em>\u2014a term that only partially aligns with the notion of <em>subsumption<\/em>, often used in English-language legal theory.<br><br>Second, the special issue is intended to be dynamic. This reflects the specific temporal relationship between law and biomedical or biotechnological innovations\u2014or more broadly, biolaw\u2014as outlined above. In this regard, the online and open-access format provided by <em>Confluence des droits_La Revue<\/em> offers the opportunity for this special issue to be enriched over time, through contributions from the legal scholarly community and, more broadly, from the field of science and technology studies. While the special issue initiates and brings together discussions on the legal definitions and concepts of biolaw, it is designed to be progressively expanded and continuously developed in an accessible and collaborative space.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<p class=\"has-text-align-left\"><a href=\"#_ftnref1\" id=\"_ftn1\">[1]<\/a>*&nbsp; For some specific examples, see : L.-M.&nbsp;Schmit, <a href=\"https:\/\/doi.org\/10.4000\/books.putc.2335\">Les d\u00e9finitions en droit priv\u00e9<\/a>, Presses de l\u2019Universit\u00e9 Toulouse Capitole, Librairie g\u00e9n\u00e9rale de droit et de jurisprudence, 2017, <a href=\"https:\/\/doi.org\/10.4000\/books.putc.2335\">https:\/\/doi.org\/10.4000\/books.putc.2335<\/a>; D.&nbsp;Truchet, \u00ab&nbsp;Les d\u00e9finitions l\u00e9gislatives&nbsp;\u00bb, in R.&nbsp;Drago (dir.), <em>La confection de la loi<\/em>, PUF, 2005, p. 193&nbsp;; C.&nbsp;Eiseinmann, \u00ab&nbsp;Quelques probl\u00e8mes de m\u00e9thodologie des d\u00e9finitions et des classifications en science juridique&nbsp;\u00bb, <em>APD<\/em>, 1966, pp. 25\u201343&nbsp;; C.&nbsp;Wolmark, <em>La d\u00e9finition pr\u00e9torienne. \u00c9tude en droit du travail<\/em>, Th\u00e8se, Univ. Paris 10, Dalloz, coll. Nouvelle biblioth\u00e8que de th\u00e8ses, 2007; A.&nbsp;Rey, \u201cPolys\u00e9mie du terme d\u00e9finition\u201d, in <em>La d\u00e9finition<\/em>, Colloque du Centre d\u2019\u00e9tude du lexique, Larousse, coll. Langue et Langage, 1990.<\/p>\n\n\n\n<p><a href=\"#_ftnref2\" id=\"_ftn2\">[2]<\/a> By way of exception, particular mention should be made of M.&nbsp;Glinel, <em>Qualification juridique et d\u00e9limitation des comp\u00e9tences normatives de l\u2019Union europ\u00e9enne : l\u2019exemple des biotechnologies<\/em>, Th\u00e8se Droit, Universit\u00e9 Toulouse Capitole, 2023.<\/p>\n\n\n\n<p><a href=\"#_ftnref3\" id=\"_ftn3\">[3]<\/a> Here we take up a distinction, the conceptual triangle, generally attributed to C.&nbsp;K.&nbsp;Ogden and I.&nbsp;A.&nbsp;Richards, <em>The Meaning of Meaning<\/em>, Hartcourt, Brace &amp; World, 1923.<\/p>\n\n\n\n<p><a href=\"#_ftnref4\" id=\"_ftn4\">[4]<\/a> Article 1, Directive 2001\/83\/CE of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (6 November 2001) [2001] <em>OJ L<\/em>311\/67.<\/p>\n\n\n\n<p><a href=\"#_ftnref5\" id=\"_ftn5\">[5]<\/a> Article 4, Proposal for a Directive of the European Parliament and the Council on the Union code relating to medicinal products for human use, and repealing Directive 2001\/83\/EC and Directive 2009\/35\/EC, COM(2023) 192 final.<\/p>\n\n\n\n<p><a href=\"#_ftnref6\" id=\"_ftn6\">[6]<\/a> EMA, Guideline on clinical evaluation of vaccines, 16 January 2023, EMEA\/CHMP\/VWP\/164653\/05 Rev. 1.<\/p>\n\n\n\n<p><a href=\"#_ftnref7\" id=\"_ftn7\">[7]<\/a> Article 4(11), Proposal for a Directive, COM(2023) 192 final, <em>op. cit.<\/em><\/p>\n\n\n\n<p><a href=\"#_ftnref8\" id=\"_ftn8\">[8]<\/a> Regulation (EU) 2024\/1938 of the European Parliament and of the Council of 13 June 2024 on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002\/98\/EC and 2004\/23\/EC (13 June 2024) [2024] OJ L1938.<\/p>\n\n\n\n<p><a href=\"#_ftnref9\" id=\"_ftn9\">[9]<\/a> For instance, \u201cNo medicinal product may be placed on the market of a Member State unless a marketing authorisation has been issued by the competent authorities\u201d, Article 6(1), Directive 2001\/83\/EC, <em>op. cit.<\/em><\/p>\n\n\n\n<p><a href=\"#_ftnref10\" id=\"_ftn10\">[10]<\/a> For instance, on the same topic: \u201cThe obligation to secure a marketing authorisation, warranting safety and efficacy of medicines, was introduced for all medicines marketed within the then European Economic Community (EEC), setting in motion the EU\u2019s precautionary approach to risk of harm from medicines.\u201d T.&nbsp;K.&nbsp;Hervey, Health law, in S.&nbsp;Garben, L.&nbsp;Gormley, <em>The Oxford Encylopedia of EU Law [OEEUL]<\/em>, June 2022.<\/p>\n\n\n\n<p><a href=\"#_ftnref11\" id=\"_ftn11\">[11]<\/a> \u201cA type of SoHO that: (a) has been subjected to processing and, where relevant, one or more other SoHO activities referred to in Article 2(1), point (c); (b) has a specific clinical indication; and (c) is intended for human application to a SoHO recipient or is intended for distribution\u201d. Article 3(37), SoHO Regulation, <em>op. cit.<\/em><\/p>\n\n\n\n<p><a href=\"#_ftnref12\" id=\"_ftn12\">[12]<\/a> \u201c\u2018Processing\u2019 means any operation involved in the handling of SoHO, including, but not limited to, washing, shaping, separation, decontamination, sterilisation, preservation and packaging, except for the preparatory handling of SoHO for immediate human application during a surgical intervention, without the SoHO being removed from the surgical field before they are applied\u201d. Article 3(23), SoHO Regulation, <em>op. cit.<\/em><\/p>\n\n\n\n<p><a href=\"#_ftnref13\" id=\"_ftn13\">[13]<\/a> For more information on this project, please visit <a href=\"https:\/\/elsibi.hypotheses.org\/i-biolex\">the project website<\/a> here.<\/p>\n\n\n\n<p><a href=\"#_ftnref14\" id=\"_ftn14\">[14]<\/a> In this respect, see in particular: M.&nbsp;Flear, A.-M.&nbsp;Farrell, T.&nbsp;Hervey, T.&nbsp;Murphy, European Law and New Health Technologies, Oxford University Press, Oxford 2013, 477 p.<\/p>\n\n\n\n<p><a id=\"_ftn15\" href=\"#_ftnref15\">[15]<\/a> In this respect, see in particular: A.&nbsp;Mahalatchimy, E.&nbsp;Rial-Sebbag (dir.), <em>L\u2019Humain m\u00e9dicament<\/em>, <em>Quaderni<\/em> n\u00b0&nbsp;81, printemps 2013, \u00c9ditions de la Maison des sciences de l&rsquo;homme Paris, 194 p.<\/p>\n\n\n\n<p><a id=\"_ftn16\" href=\"#_ftnref16\">[16]<\/a> In this respect, see in particular: C.&nbsp;Chabannon, et al., <em>Les unit\u00e9s de th\u00e9rapie cellulaire \u00e0 l\u2019\u00e9preuve de la r\u00e8glementation sur les m\u00e9dicaments de th\u00e9rapie innovante<\/em>, <em>M\u00e9decine\/Sciences<\/em>, mai 2014, 30 (5), <br>pp.&nbsp;576\u2013583.<\/p>\n\n\n\n<p><a href=\"#_ftnref17\" id=\"_ftn17\">[17]<\/a> S.&nbsp;Jasanoff, <em>States of knowledge: the co- production of knowledge and social order<\/em>, Routledge 2004.<\/p>\n\n\n\n<p><a id=\"_ftn18\" href=\"#_ftnref18\">[18]<\/a> R.&nbsp;Brownsword, K.&nbsp;Yeung,&nbsp;\u201c<em>Regulating Technologies: Legal futures, regulatory frames and technological fixes<\/em>\u201d, Hart Publishing 2008, pp.&nbsp;3\u201322.<\/p>\n\n\n\n<p><a href=\"#_ftnref19\" id=\"_ftn19\">[19]<\/a> A.&nbsp;Faulkner, <em>Regulatory policy as innovation: constructing rules of engagement of a technological zone for tissue engineering in the European Union<\/em>, Research Policy, 2009, 38, pp. 596\u2013615.<\/p>\n\n\n\n<p><a href=\"#_ftnref20\" id=\"_ftn20\">[20]<\/a> A.-C.&nbsp;Martineau, <em>Le d\u00e9bat sur la fragmentation du droit international \u2013 Une analyse critique<\/em>, Bruylant, 2015.<\/p>\n\n\n\n<p><a id=\"_ftn21\" href=\"#_ftnref21\">[21]<\/a> See the contributions of <a href=\"https:\/\/confluencedesdroits-larevue.com\/?p=4180\" class=\"ek-link\">Matthieu Guerriaud<\/a>; <a href=\"https:\/\/confluencedesdroits-larevue.com\/?p=4183\" class=\"ek-link\">Katrina Peherudoff and Elena Pires<\/a>; <a href=\"https:\/\/confluencedesdroits-larevue.com\/?p=4176\" class=\"ek-link\">Audrey Lebret<\/a>; <a href=\"https:\/\/confluencedesdroits-larevue.com\/?p=4182\" class=\"ek-link\">Gauthier Chassang, Lisa Feriol, and No\u00e9mie Dubruel<\/a>; <a href=\"https:\/\/confluencedesdroits-larevue.com\/?p=4178\" class=\"ek-link\">Adrien Bottacci<\/a>; <a href=\"https:\/\/confluencedesdroits-larevue.com\/?p=4181\" class=\"ek-link\">\u00c9lo\u00efse Gennet and Aur\u00e9lie Mahalatchimy<\/a>.<\/p>\n\n\n\n<p><a id=\"_ftn22\" href=\"#_ftnref22\">[22]<\/a> See the contributions of <a href=\"https:\/\/confluencedesdroits-larevue.com\/?p=4179\" class=\"ek-link\">Estelle Brosset<\/a> and <a href=\"https:\/\/confluencedesdroits-larevue.com\/?p=4177\" class=\"ek-link\">Valentine Delcroix<\/a>.<\/p>\n\n\n\n<p><a id=\"_ftn23\" href=\"#_ftnref23\">[23]<\/a> See the contributions of <a href=\"https:\/\/confluencedesdroits-larevue.com\/?p=4179\" class=\"ek-link\">Estelle Brosset<\/a>, <a href=\"https:\/\/confluencedesdroits-larevue.com\/?p=4177\" class=\"ek-link\">Valentine Delcroix<\/a>, <a href=\"https:\/\/confluencedesdroits-larevue.com\/?p=4183\" class=\"ek-link\">Katrina Peherudoff and Elena Pires<\/a>, <a href=\"https:\/\/confluencedesdroits-larevue.com\/?p=4181\" class=\"ek-link\">\u00c9lo\u00efse Gennet and Aur\u00e9lie Mahalatchimy<\/a>.<\/p>\n\n\n\n<p><a id=\"_ftn24\" href=\"#_ftnref24\">[24]<\/a> See the contributions of <a href=\"https:\/\/confluencedesdroits-larevue.com\/?p=4176\" class=\"ek-link\">Audrey Lebret<\/a>, and of <a href=\"https:\/\/confluencedesdroits-larevue.com\/?p=4182\" class=\"ek-link\">Gauthier Chassang, Lisa Feriol, and No\u00e9mie Dubruel<\/a>.<\/p>\n\n\n\n<p><a id=\"_ftn25\" href=\"#_ftnref25\">[25]<\/a> See the contributions of <a href=\"https:\/\/confluencedesdroits-larevue.com\/?p=4184\" class=\"ek-link\">Xavier Bioy<\/a>, and <a href=\"https:\/\/confluencedesdroits-larevue.com\/?p=4178\" class=\"ek-link\">Adrien Bottacci<\/a>.<\/p>\n\n\n\n<p><a id=\"_ftn26\" href=\"#_ftnref26\">[26]<\/a> See the contribution of <a href=\"https:\/\/confluencedesdroits-larevue.com\/?p=4180\" class=\"ek-link\">Matthieu Guerriaud<\/a>.<\/p>\n\n\n\n<p><a href=\"#_ftnref27\" id=\"_ftn27\">[27]<\/a> This is the case not only of contributions relating to substances of human origin, organoids, gene therapy medicinal products, biomedical innovations and genetically modified organisms, but also to the human species, privacy and unmet medical needs.<\/p>\n\n\n\n<p><a href=\"#_ftnref28\" id=\"_ftn28\">[28]<\/a> On this approach, see Marie Glinels contribution and Xavier Magnons synthesis.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<div class=\"wp-block-file\"><a id=\"wp-block-file--media-e1f0d1da-9db1-4d13-8f82-32e67ede4a30\" href=\"https:\/\/confluencedesdroits-larevue.com\/wp-content\/uploads\/2025\/07\/Why-a-special-issue-on-definitions-and-concepts-in-biolaw_A.-Mahalatchimy_X.-Magnon_M.-Glinel-07-25.pdf\">Why-a-special-issue-on-definitions-and-concepts-in-biolaw_A.-Mahalatchimy_X.-Magnon_M.-Glinel-07-25<\/a><a href=\"https:\/\/confluencedesdroits-larevue.com\/wp-content\/uploads\/2025\/07\/Why-a-special-issue-on-definitions-and-concepts-in-biolaw_A.-Mahalatchimy_X.-Magnon_M.-Glinel-07-25.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-e1f0d1da-9db1-4d13-8f82-32e67ede4a30\"><\/a><\/div>\n\n\n\n<p class=\"has-text-align-justify has-background\" style=\"background-color:#ededed\">Aur\u00e9lie Mahalatchimy, Xavier Magnon, Marie Glinel, \u201cWhy a special issue on definitions and concepts in biolaw?\u2009\u201d, D\u00e9finition et concepts du biodroit [Dossier], <em>Confluence des droits_La&nbsp;revue <\/em>[En&nbsp;ligne], 07&nbsp;|&nbsp;2025, mis&nbsp;en ligne le 7 juillet 2025. URL : <a href=\"https:\/\/confluencedesdroits-larevue.com\/?p=4175\" class=\"ek-link\"><u>https:\/\/confluencedesdroits-larevue.com\/?p=<\/u>4175<\/a>.<\/p>\n\n<\/div>\n\n            <\/div>\n        <\/div>\n    <\/div>","protected":false},"excerpt":{"rendered":"<p>Aur\u00e9lie Mahalatchimy, Charg\u00e9e de recherche au CNRS en droit, Aix Marseille Univ, CNRS, DICE, CERIC, Aix-en-Provence, France | Xavier Magnon, Professeur de droit public, Aix Marseille Univ, CNRS, DICE, ILF, Aix-en-Provence, France | Marie Glinel, Ma\u00eetre de conf\u00e9rence en droit public \u00e0 l&rsquo;Universit\u00e9 Lyon II Lumi\u00e8re<\/p>\n","protected":false},"author":2,"featured_media":4269,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_editorskit_title_hidden":false,"_editorskit_reading_time":0,"_editorskit_is_block_options_detached":false,"_editorskit_block_options_position":"{}","footnotes":""},"categories":[5,3,13],"tags":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v21.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Aur\u00e9lie Mahalatchimy, Xavier Magnon, Marie Glinel \u2013 Pourquoi un\u00a0dossier sur les d\u00e9finitions et les concepts du\u00a0biodroit\u00a0? 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