Aurélie Mahalatchimy

Chargé de recherche, Sociologie et sciences du droit.

Droits International, Comparé et Européen — DICE

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Actualités scientifiques

Colloque

Le droit du vivant

26 mars 2026 · Le Mans

Colloque

Aux frontières du droit de la santé

20 nov. 2025 · Aix-en-Provence

Parution

Transhumanisme : de nouveaux droits ?

13 juil. 2024

Colloque

L'expertise internationale dans les domaines de la santé et de l'envi…

28 juin 2023 · Aix-en-Provence

Séminaire

Biotechnologies : quelle sagesse collective ?

11 mai 2023

Colloque

La natalité comme enjeu stratégique de politique de santé publique

15 déc. 2022

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Publications scientifiques

Thèse
THESE
L'impact du droit de l'Union européenne sur la règlementation des médicaments de thérapie innovante en France et au Royaume-Uni, soutenue en 2015 à Toulouse 1 sous la direction de Nathalie De Grove-Valdeyron et Florence Taboulet
Les produits de santé fabriqués à base de gènes, cellules et tissus, interrogent les cadres juridiques existants en raison de leur caractère innovant, de la complexité de leurs procédés de fabrication, de leur origine humaine ou animale, des espoirs thérapeutiques suscités face aux risques mal connus qu’ils engendrent, et de leur fort potentiel lucratif. Le droit de l’Union a établi la catégorie juridique des « médicaments de thérapie innovante » pour certains de ces produits de santé afin d’assurer le bon fonctionnement du marché intérieur et de garantir un niveau élevé de protection de la santé publique. Face à ces objectifs, le régime juridique européen est spécifique tout au long de leur cycle de vie par rapport aux médicaments de droit commun. L’application de cette règlementation européenne en France et au Royaume- Uni bouleverse le secteur : les exigences de sécurité sanitaire sont renforcées, la fabrication industrielle et l’accès au marché sont favorisés. Mais l’impact de cette règlementation n’est pas à la hauteur de cette remarquable anticipation règlementaire européenne : seuls quatre médicaments de thérapie innovante sont aujourd’hui autorisés. D’une part, un décalage apparaît entre l’articulation juridique des compétences découlant des traités et la délimitation des règlementations européenne et nationales au regard des objectifs de protection de la santé publique et de bon fonctionnement du marché intérieur, mais également des enjeux éthiques soulevés par ces médicaments. D’autre part, l’accès réel des patients à des médicaments de thérapie innovante sûrs soulève encore de nombreux enjeux règlementaires.
Ouvrages
Aurélie Mahalatchimy, Guylène Nicolas, Transhumanisme , 22^e éd., DICE Éditions, 2024, 281 p.
Aurélie Mahalatchimy, Challenges for the implementation of the current EU legal frameworks to organoids, 4^e éd., Acad{\'e}mies des sciences morales et politiques / Institut de France, 2024, 4756 p.
Aurélie Mahalatchimy, Ali Bencheneb, Olivier Debarge, Michel Cotnoir, Éric Fouassier [et alii], Le monopole pharmaceutique et son avenir: actes du colloque de Paris, 11 octobre 2016, de l'Association française de droit de la santé (AFDS), LEH édition, 2018
Aurélie Mahalatchimy, Eric Bauvin, Marie-Pierre Bichet, Jean-François Calmette, Lucie Chabrol [et alii], Les maladies rares, une voie pour la santé de demain ?: actes du colloque universitaire, LEH édition, 2017, Actes et séminaires
Aurélie Mahalatchimy, Emmanuelle Rial-Sebbag (dir.), L'humain médicament, Ed. de la Maison des sciences de l'homme, 2013, 119 p.
Aurélie Mahalatchimy, La nouvelle règlementation applicable aux médicaments de thérapie innovante, 2007, 131 p.
Chapitres d'ouvrage
Aurélie Mahalatchimy, « Le vivant humain singularisé et le droit de l’Union européenne », in Magali Bouteille- Brigant (dir.), Le droit du vivant, Institut Louis Joinet (IFJD), 2026
Aurélie Mahalatchimy, « Le biodroit comme modèle des nouveaux enjeux prioritaires du droit pharmaceutique de l’Union européenne », in Maria FARTUNOVA-MICHEL, Béligh NABLI (dir.), Quel biodroit pour l’Union européenne ?, Bruylant, 2025
Aurélie Mahalatchimy, Christian Chabannon, « 49 - The Regulatory Framework for CAR-T Cells in Europe: Current Status and Foreseeable Changes », in EBMT, GoCART Coalition, EHA (dir.), The EU CAR-T Handbook, Open Access, 2025, pp. 50-49
Aurélie Mahalatchimy, Guylène Nicolas, Martine Perron, « Du transhumain au posthumain : quels droits fondamentaux ? », in Guylène Nicolas, Aurélie Mahalatchimy (dir.), Transhumanisme : de nouveaux droits ?, DICE Éditions, 2024, pp. 15-31
Aurélie Mahalatchimy, Guylène Nicolas, « Les droits fondamentaux comme frontières de la médecine améliorative de l'humain : l'application du principe d'égalité », in Amandine Cayol, Bénédicte Bévière-Boyer, Wei Wang, Emilie Gaillard (dir.), Le transhumanisme à l'ère de la médecine améliorative, mare & martin, 2024
Aurélie Mahalatchimy, « Regulation of Genome Editing in Human iPS Cells: France », in Hans-Georg Dederer, Gregor Frenken (dir.), Genome Editing in Human iPS Cells: A Comparative Legal Analysis of National Regulatory Frameworks for iPSC-based Cell/Gene Therapies, Springer, 2022
Aurélie Mahalatchimy, Emmanuelle Rial-Sebbag, « Le génome humain édité : risques et gouvernance », N. De Grove-Valdeyron (dir.), Innovation et Analyse des risques dans le domaine de la santé et des produits de santé dans l'Union Européenne : regards croisés, 2020
Aurélie Mahalatchimy, Erika Lietzan, Patricia Zettler, « Introduction to Medical Products Law », The Oxford Handbook of Comparative Health Law Edited by David Orentlicher and Tamara Hervey, Oxford University Press, 2020
Aurélie Mahalatchimy, « Regulating Medical Devices in the European Union », The Oxford Handbook of Comparative Health Law Edited by David Orentlicher and Tamara Hervey, Oxford University Press, 2020
Aurélie Mahalatchimy, « Regulating Medicines in the European Union », The Oxford Handbook of Comparative Health Law Edited by David Orentlicher and Tamara Hervey, Oxford University Press, 2020
Aurélie Mahalatchimy, Anne-Marie Duguet, Wen Meng, Heidi Howard, « In need for a modern Daedalus? The challenging regulatory path for marketing gene therapy medicinal products in China and Europe », in Q. Yanping, A.-M. Duguet (dir.), Biotechnology Medicine and Law, China University of Political Science and Law Press, 2018
Aurélie Mahalatchimy, Jean Mchale, Estelle Brosset, « EU law and policy on new health technologies », in T. K. HERVEY, C. A. YOUNG (dir.), Research Handbook in EU Health Law and Policy, Edward Elgar Publishing, 2017
Aurélie Mahalatchimy, Velizara Anastasova, Anne Cambon-Thomsen, « Legal and ethical issues in European projects MeDALL & EuroTARGET dealing with biomarkers », in Anne- Marie Duguet (dir.), Aspects légaux et éthiques du commencement de la vie, Les Etudes Hospitalières, 2015
Aurélie Mahalatchimy, Anne-Marie Duguet, « Recherche et maladies rares, le cas des mineurs: principes éthiques et protection des sujets vulnérables », in Isabelle Poirot- Mazères, Paul Gimenes (dir.), Les maladies rares, une voie pour la santé de demain, LEH Edition, 2015
Aurélie Mahalatchimy, Velizara Anastasova, Emmanuelle Rial-Sebbag, Anne Cambon-Thomsen, « Le consentement éclairé dans la recherche pédiatrique : aspects internationaux », in Sous la direction de l'Association française de droit de la santé, Anne Laude, Président (dir.), Consentement et santé, Dalloz, 2014
Aurélie Mahalatchimy, « Risques et médicaments de thérapie innovante : quelle règlementation en droit de l’Union européenne ? », in Nathalie De Grove- Valdeyron (dir.), La sécurité des produits de santé dans l'Union européenne, Presses de l'Université des Sciences Sociales de Toulouse, 2014
Aurélie Mahalatchimy, Velizara Anastasova, Emmanuelle Rial-Sebbag, Anne Cambon-Thomsen, « Legal, ethical and social issues in longitudinal studies involving children. An example: The MeDALL project », in Anne- Marie Duguet (dir.), Actions pour la santé et la recherche médicale en faveur des personnes vulnérables et des pays émergents, Les Etudes Hospitalières, 2012
Aurélie Mahalatchimy, Emmanuelle Rial-Sebbag, Anne Cambon-Thomsen, Katherine Griesche, « Ethical issues linked to inequality of access aspects to transplantation and accompanying treatments throughout Europe », in Anne- Marie Duguet, Isabelle Filippi, Louise Deffrennes (dir.), Droit des patients, mobilité et accès aux soins, Les Etudes Hospitalières, 2011
Aurélie Mahalatchimy, Florence Taboulet, « L'accès aux médicaments orphelins dans l'Union européenne », in Anne-Marie Duguet, Isabelle Filippi (dir.), Droit de la santé publique dans un contexte transnational, Les Etudes Hospitalières, 2010
Aurélie Mahalatchimy, « Judicial aspects of the advanced therapies’ clinical assays for the graft », in Anne-Marie Duguet, Isabelle Filippi, Jean Herveg (dir.), Accès aux transplantations d’organes et de tissus en Europe, et droits aux soins en Europe, Les Etudes Hospitalières, 2009
Aurélie Mahalatchimy, « Aspects juridiques des essais cliniques des thérapies innovantes pour les greffes (Ré- édition) », in Marc Blanquet, Nathalie De Grove-Valdeyron (dir.), Etudes de droit communautaire de la santé et du médicament, Presses de l'Université des Sciences Sociales de Toulouse, 2009
Aurélie Mahalatchimy, Emmanuelle Rial-Sebbag, Denis Chartier, Anne Cambon-Thomsen, « A new proposal to help researchers in the respect of legal requirements for the exchange of human biological material », in Jane Kaye, Mark Stranger (dir.), Principles and Practice in Biobank Governance, Ashgate, 2009
Articles
Aurélie Mahalatchimy, Marie Glinel, Tamara K. Hervey, « Understanding European Union Substances of Human Origin Case Law through Defragmentation and Fragmentation », European Journal of Health Law, Brill Academic Publishers, 2026, pp. 1-23
Regulation of Substances of Human Origin (SoHO) is an important topic of Union health law both in the context of research and in the context of healthcare services and treatment of patients. When we observe Union SoHO law, we do not only observe a linear movement towards greater harmonisation and less differentiation between national laws. At the same time as the 'expected' harmonisation processes of an inexorable process of greater Union law coverage of a field, and less space for national difference, we also observe counter-processes in the opposite direction. Focusing on the role of the Court of Justice of the Union to understand the dynamics of Union regulation of the sector through the analysis of 19 SoHO cases, this article proposes two new legal analytical concepts to explain these processes: 'defragmentation' and 'fragmentation' 10.1163/15718093-bja10166 | European Journal of Health Law (2026) 1-23 which provide an explanatory model as a tool of legal science to use to promote greater understanding of Union law.
Aurélie Mahalatchimy, Tamara Hervey, Ollie Bartlett, Joaquín Cayón-de las Cuevas, Vincent Delhomme, « Conceptualising European Union health law », European Journal of Health Law, Brill Academic Publishers, 2026
A collectively authored article, which (unusually in legal scholarship) makes explicit the processes and methodologies by which 'European Union health law' is conceptualised; the implications; and the strengths and weaknesses of the approach taken. Strengths include implied structural and systemic coherence; and the breadth of analysis that having a large team of authors permits, through holding their positionalities in creative interplay with each other. The authors argue that European Union health law -defined as transversal and distinctively European Union law that either directly or indirectly affects human health, in a broad sense -should be understood through a metaphor of growth and connectedness, specifically a 'tree' . The article seeks to initiate a discussion not only about European Union health law, but also about European law and health law.
Aurélie Mahalatchimy, Marie Glinel, Xavier Magnon, « Dossier: Définitions et concepts du biodroit », Confluence des droits_La revue, UMR 7318 Droits International, Comparé et Européen (DICE), 2025
Aurélie Mahalatchimy, Xavier Magnon, Marie Glinel, « Pourquoi un dossier sur les définitions et les concepts du biodroit ? », Confluence des droits_La revue, UMR 7318 Droits International, Comparé et Européen (DICE), 2025
Aurélie Mahalatchimy, Xavier Magnon, Marie Glinel, « Why a special issue on definitions and concepts in biolaw? », Confluence des droits_La revue, UMR 7318 Droits International, Comparé et Européen (DICE), 2025
Aurélie Mahalatchimy, Éloïse Gennet, « Is there a legal concept of biomedical innovations in EU binding law? », Confluence des droits_La revue, UMR 7318 Droits International, Comparé et Européen (DICE), 2025
Aurélie Mahalatchimy, Éloïse Gennet, « How does EU non-binding law contribute to the scientific concept of biomedical innovations? », Confluence des droits_La revue, UMR 7318 Droits International, Comparé et Européen (DICE), 2025
Aurélie Mahalatchimy, Valentin Roby, Julie Véran, Christian Chabannon, « Mapping the European landscape and specificity of ATMPs guidance », Cytotherapy, Elsevier, 2025, n°10
Aurélie Mahalatchimy, Michael Morrison, Valentin Brunel, « Participation in SoHO and ATMP public consultations: a fragmented institutional landscape », Humanities and Social Sciences Communications, Nature, 2025
Aurélie Mahalatchimy, Éloïse Gennet, « La plateforme des politiques de santé de l'Union européenne : un outil de participation civile à la construction du droit », Revue de l'Union européenne, {\'E}ditions techniques et {\'e}conomiques - Dalloz, 2023, n°664, p. 52
Aurélie Mahalatchimy, Emmanuelle Rial-Sebbag, « Deciphering the fragmentation of the human genome editing regulatory landscape », Frontiers in Political Science, Frontiers, 2022, n°3
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 successfully 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 paper 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 technico-legal 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.
Aurélie Mahalatchimy, Éloïse Gennet, « La plateforme des politiques de santé de l'Union européenne : un outil de participation civile à la construction du droit », Revue de l'Union européenne, {\'E}ditions techniques et {\'e}conomiques - Dalloz, 2022
L’Union européenne (UE) tend à favoriser l’ouverture des processus d’élaboration des politiques publiques à la participation civile. La plateforme des politiques de santé de l’UE en offre une illustration originale : un espace privilégié et permanent de dialogue de représentants de citoyens avec la Commission européenne permet d’informer et d’influencer les politiques de santé, comme en témoigne la création d’un réseau thématique sur la législation pharmaceutique européenne en pleine révision.
Aurélie Mahalatchimy, « Le développement de la solidarité et la circulation des ressources biologiques humaines », Actualité juridique Droit administratif, Dalloz, 2021, n°32, p. 1856
Aurélie Mahalatchimy, Pin Lau, Phoebe Li, Mark Flear, « Framing and legitimating EU legal regulation of human gene-editing technologies: key facets and functions of an imaginary », Journal of Law and the Biosciences, 2021
Gene-editing technologies, i.e. those able to make changes in the DNA of an organism, are the object of global competition and a regulatory race between countries and regions. There is an attempt to craft legal frameworks protective enough for users, but flexible enough for developers of gene-editing technologies. This article examines the imaginary built into the framing of EU-level legal regulation of human gene-editing technologies and identifies its three key related facets: the tension around naturalness; safeguarding morality and ethics; and the pursuit of medical objectives for the protection of human health. Concerns around the use of gene-editing technologies in relation to eugenics and human enhancement have produced a multi-faceted imaginary. We argue that this imaginary not only places a limit on EU-level regulation, despite a strong EU competence in respect of the internal market, but also seeks to ensure its legitimation.
Aurélie Mahalatchimy, Jean-Christophe Galloux, « Réflexions prospectives sur l’économie du trans-humanisme », Droit, Santé et Société, Droit, Santé et Société, 2021, n°3-4, pp. 82-87
La dimension économique du transhumanisme est très peu discutée, notamment d’un point de vue juridique, en ce qu’elle est largement prospective. Cet article a donc pour objet de susciter le débat sur ce sujet en proposant quelques pistes de réflexions. Sont ainsi identifiés et discutés les aspects liés à la diversité des acteurs économiques impliqués, au financement du développement des technologies transhumanistes, aux mécanismes juridiques à fort impact économique, et à la régulation du marché de ces technologies. Face à ces enjeux principaux de l’économie du transhumanisme, les principes fondamentaux de responsabilité, de non-discrimination, d’équité et de solidarité, reconnus dans la plupart de nos systèmes juridiques actuels, devraient être réaffirmés et explicités dans le cadre du transhumanisme, à tout le moins par la voie des actes déclaratoires, à l’initiative d’institutions internationales.
Aurélie Mahalatchimy, Jean-Christophe Galloux, « Réflexions prospectives sur l'économie du trans-humanisme », Droit, Santé et Société, Eska, 2021, n°3, pp. 82-87
La dimension économique du transhumanisme est très peu discutée, notamment d'un point de vue juridique, en ce qu'elle est largement prospective. Cet article a donc pour objet de susciter le débat sur ce sujet en proposant quelques pistes de réflexions. Sont ainsi identifiés et discutés les aspects liés à la diversité des acteurs économiques impliqués, au financement du développement des technologies transhumanistes, aux mécanismes juridiques à fort impact économique, et à la régulation du marché de ces technologies. Face à ces enjeux principaux de l'économie du transhumanisme, les principes fondamentaux de responsabilité, de nondiscrimination, d'équité et de solidarité, reconnus dans la plupart de nos systèmes juridiques actuels, devraient être réaffirmés et explicités dans le cadre du transhumanisme, à tout le moins par la voie des actes déclaratoires, à l'initiative d'institutions internationales.
Aurélie Mahalatchimy, « Pour une stratégie de l’Union européenne dans le domaine de l’innovation en santé », Revue de l'Union européenne, {\'E}ditions techniques et {\'e}conomiques - Dalloz, 2019, n°624, pp. 22-29
La réglementation des innovations en santé, qui soulèvent à la fois de nombreux espoirs thérapeutiques et économiques mais aussi des risques, est essentielle et complexe. Le droit de l’Union Européenne (UE) s’est intéressé à ces innovations notamment à travers diverses règlementations, telles celles relatives aux médicaments de thérapie innovante ou aux cellules et tissus humains. Au sein de l’UE, il existe une stratégie européenne d’innovation en santé transversale et implicite, actuellement intégrée à diverses autres stratégies qui ont pour objectif le renforcement de l’économie et l’amélioration de la santé. Cette contribution soutient que l’UE devrait explicitement adopter une telle stratégie : elle discute de son intérêt et de son contenu.
Aurélie Mahalatchimy, « Médicaments de thérapie innovante et gestion des risques : quelle place pour le principe de précaution? », Revue du droit de l'Union européenne, {\'E}ditions Cl{\'e}ment Juglar (Paris, France) - Bruylant (Bruxelles et Belgique), 2019, pp. 49-62
Aurélie Mahalatchimy, Virginie Tournay, Annette Leibing, Coralie Mounet, « Ceci n’est pas une cellule souche. Du laboratoire au musée : le défi de la compréhension de la complexité biologique », RDST - Recherches en didactique des sciences et des technologies, ENS Éditions, 2018, n°17
L’ingénierie cellulaire et tissulaire est devenue un enjeu social et politique fort, qui implique des règlementations et des informations adaptées à la réalité biologique couverte par ces biotechnologies. Cet état de fait pose nombre de défis didactiques dans la structuration du débat scientifique ainsi que dans la mise en œuvre de politiques culturelles adaptées. En effet, l’état de « souche » est un terme scientifiquement polysémique qui suscite des malentendus accentués par le fait que le mode de qualification de la cellule « souche » en droit et en biologie n’est pas comparable. Malheureusement, la complexité des terminologies employées pour décrire le monde vivant est souvent occultée dans les débats publics et sous-estimée dans les stratégies de communication scientifiques. Or, ces aspects sémantiques posent des défis à la compréhension publique de la médecine dite « régénératrice ». Ils interrogent les cadrages de l’action publique culturelle et les régimes de visualisation de la complexité biologique.
Aurélie Mahalatchimy, « La promotion de l’innovation en matière de santé: quelles logiques à l’œuvre dans l’Union européenne? », Revue des Affaires européennes/Law European & Affairs, Bruylant / Larcier (en ligne), 2018
L’innovation dans le domaine de la santé suscite à la fois espoirs et craintes. Elle est valorisée et favorisée en ce qu’elle participe à l’amélioration de la santé publique et au développement économique. Mais elle est aussi contrôlée au regard des risques qu’elle peut engendrer pour la santé. Au niveau de l’Union européenne, l’innovation en santé se situe au carrefour de plusieurs stratégies européennes solides qui s’inscrivent dans les logiques d’économie, d’innovation et de recherche, et de santé publique de l’Union européenne. Si la promotion de l’innovation en santé relève principalement de la logique d’économie et d’innovation de l’Union européenne, la logique santé devrait être valorisée à travers la reconnaissance d’une stratégie européenne d’innovation en santé.
Aurélie Mahalatchimy, Alice Yuen-Ting Wong, « Human stem cells patents-Emerging issues and challenges in Europe, United States, China, and Japan », The Journal of world intellectual property, Wiley, 2018, pp. 1-30
Aurélie Mahalatchimy, Alex Faulkner, « The politics of valuation and payment for regenerative medicine products in the UK », New Genetics and Society, Taylor & Francis (Routledge), 2018
Aurélie Mahalatchimy, Nathalie de Grove-Valdeyron, « Les essais cliniques de médicaments de thérapie innovante: quel avenir pour la réglementation européenne? », International Journal of Bioethics, ESKA, 2018, n°2, pp. 35-51
Aurélie Mahalatchimy, Nathalie De Grove-Valdeyron, « Chapitre 2. Les essais cliniques de médicaments de thérapie innovante : quel avenir pour la réglementation européenne ? », Journal international de bioéthique et d'éthique des sciences, ESKA, 2018, n°2, pp. 35-51
Nous nous intéressons dans cette contribution aux enjeux liés aux essais cliniques et au droit applicable aux médicaments de thérapie innovante(MTI). En effet, d’un point de vue scientifique et technique, la caractérisation et la manipulation des cellules et tissus vivants en vue de leur utilisation thérapeutique posent problèmes pour garantir leur stabilité à long terme, en particulier au regard de leur tendance naturelle à l’évolution et à l’interaction au sein du corps humain. Il en résulte des difficultés pour garantir la sécurité et l’efficacité à long terme de ces MTI, qu’il s’agisse des risques de tumeurs, de contamination des cellules et tissus par des agents infectieux ou de rejet immunitaire ou encore, dans le cas des médicaments de thérapie génique, d’intégration du matériel génétique à un endroit non voulu. Or, les essais cliniques restent l’outil de prédilection pour prouver la sécurité et l’efficacité des médicaments. La réglementation européenne des essais cliniques des MTI contribue-t-elle au développement de ces médicaments en vue de leur accessibilité aux patients de l’Union européenne, en réponse à leurs attentes de sécurité et d’accès rapide à des traitements innovants ?
Aurélie Mahalatchimy, « Human Stem Cells Patents - Emerging Issues and Challenges in Europe, United States, China and Japan », Journal of World Intellectual Property, 2018
Aurélie Mahalatchimy, « The institutional and methodological politics of valuation and payment for regenerative medicine products in the UK », New Genetics and Society, 2018
Aurélie Mahalatchimy, Alex Faulkner, Mahalatchimy A, Faulkner A, « The emerging landscape of reimbursement of regenerative medicine products in the UK: publications, policies and politics. », Regenerative medicine, Future Medicine, 2017
Aurélie Mahalatchimy, Emmanuelle Rial-Sebbag, Anne-Marie Duguet, « Cells’ safety in the European towards an Ethical Safety », International Journal of Bioethics, Diffusion Eska, 2017
To encourage and maximise the use of human biological material in Europe, the European Commission instigated a main Directive in 2004 (Directive 2004/23/EC), four technical ones in 2006 (Commission Directives 2006/17/EC and 2006/86/EC) and in 2015 (Commission Directives (EU) 2015/565 and (EU) 2015/566). They encourage the donation of tissues and cells for transplant purposes in the safeguard of public health. Another major aim of Directive 2004/23/EC is to guarantee recipients' safety in transplantation. Hence, measures for accreditation of establishments storing, preparing and distributing tissues and cells are required to be implemented in Members States' jurisdictions. In addition, adequate training is required for the personnel directly involved in such activities. Despite the adoption of a "full legislation, " the EU legal framework for cells cannot be seen as totally harmonized. In this article we first address the issues posed at the European level by the uses of human cells as therapeutic agent with regards to their qualification: body elements? Medicinal product? We study the ways to address these bioethical dilemmas at an EU level. Then we discuss the impact of this qualification in terms of safety through the definition of safety's measures and their limits regarding the directive's scope. We conclude with the emergence of an "ethical safety".
Aurélie Mahalatchimy, « Le monopole pharmaceutique en Grande-Bretagne », Les cahiers de droit de la santé, Les {\'E}tudes hospitali{\'e}res {\'e}dition (LEH {\'E}dition), 2017
Aurélie Mahalatchimy, Christian Chabannon, Olivia Caunday-Rigot, Catherine Faucher, Ineke Slaper-Cortenbach, « Accreditation and regulations in cell therapy », ISBT Science Series, Wiley, 2016, n°1
Aurélie Mahalatchimy, « Reimbursement of cell- based regenerative therapy in the UK and France », Medical Law Review, Oxford University Press (OUP), 2016, n°2
Aurélie Mahalatchimy, Emmanuelle Rial-Sebbag, Anne-Marie Duguet, Florence Taboulet, « The impact of European embryonic stem cell patent decisions on research strategies. », Nature biotechnology, Nature Publishing Group, 2015, n°1, pp. 41-43
Aurélie Mahalatchimy, Emmanuelle Rial-Sebbag, Anne-Marie Duguet, Anne Cambon-Thomsen, « Exclusion of patentability of Embryonic stem cells in Europe: another restriction by the European Patent Office », European Intellectual Property Review, Sweet and Maxwell, 2015, n°1, pp. 25-28
On 4 February 2014, the European Patent Office decided to follow the Court of Justice of the European Union regarding the exclusion of patentability of human embryonic stem cells (hESC), when stating that it is not acceptable to patent inventions using hESC obtained either by de novo destruction of human embryos, or from publicly available hESC lines initially derived by a process destroying the human embryo.
Aurélie Mahalatchimy, John Gardner, Alex Faulkner, Andrew Webster, « Are there specific translational challenges in regenerative medicine? Lessons from other fields. », Regenerative Medicine, Future Medicine, 2015, n°7
Aurélie Mahalatchimy, « Research in biotechnology with stem cells: French and European regulations and ethical concern », Medicine and Philosophy, 2015
Aurélie Mahalatchimy, « La brevetabilité des cellules souches embryonnaires humaines : l’uniformisation du droit européen des brevets », RDSS. Revue de droit sanitaire et social, Sirey ; Dalloz, 2014, n°04, p. 699
Note sous Chambre des recours de l'OEB, décision du 4 février 2014, Technion Research and Development Foundation LTD, T2221/10
Aurélie Mahalatchimy, Florence Sabatier, Emmanuelle Rial-Sebbag, Boris Calmels, Julie Veran, « Les unités de thérapie cellulaire à l’épreuve de la réglementation sur les médicaments de thérapie innovante », Médecine/Sciences, EDP Sciences, 2014, n°5
Aurélie Mahalatchimy, Chabannon C, Sabatier F, Rial-Sebbag E, Calmels B, « [Academic cell therapy facilities are challenged by European regulation on advanced therapy medicinal products]. », Medecine sciences : M/S, 2014
Aurélie Mahalatchimy, Velizara Anastasova, Emmanuelle Rial‐sebbag, Josep Antó Boqué, « Communication of results and disclosure of incidental findings in longitudinal paediatric research. », Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology, Wiley, 2013
Aurélie Mahalatchimy, Virginie Tournay, Emmanuelle Rial-Sebbag, Doerte Bemme, « Producing 'Human Elements Based Medical Technologies' in Biotech Companies: Some Ethical and Organisational Ingredients for Innovative Cooking », Science, Technology and Society, SAGE Publications, 2013, n°1
Aurélie Mahalatchimy, Emmanuelle Rial-Sebbag, « Avant-Propos : Contexte et enjeux soulevés par l’encadrement des thérapies innovantes », Quaderni, {\'E}ditions de la Maison des Sciences de l'Homme, 2013, n°81, pp. 5-13
Aurélie Mahalatchimy, Emmanuelle Rial-Sebbag, « Le Diagnostic pré- implantatoire – HLA, Etude normative comparée », Quaderni, {\'E}ditions de la Maison des Sciences de l'Homme, 2013, n°81, pp. 77-83
Aurélie Mahalatchimy, Emmanuelle Rial-Sebbag, « Entretien avec Mme Annick Schwebig, Présidente du Comité Biotechnologies du Leem », Quaderni, {\'E}ditions de la Maison des Sciences de l'Homme, 2013, n°81, pp. 85-88
Aurélie Mahalatchimy, Emmanuelle Rial-Sebbag, « Entretien avec Mme Sophie Samuel-Lucas, Pôle Thérapies innovantes et produits issus du corps humain à l’ANSM », Quaderni, {\'E}ditions de la Maison des Sciences de l'Homme, 2013, n°81, pp. 89-94
Aurélie Mahalatchimy, Emmanuelle Rial-Sebbag, « L’Humain médicament », Quaderni, {\'E}ditions de la Maison des Sciences de l'Homme, 2013, n°81, pp. 1-94
Aurélie Mahalatchimy, Emmanuelle Rial-Sebbag, Nathalie de Grove-Valdeyron, Virginie Tournay, « The European Medicines Agency: A public Health European Agency? », Medicine and law, 2012, n°1, pp. 25-42
Aurélie Mahalatchimy, Emmanuelle Rial-Sebbag, Virginie Tournay, Alex Faulkner, « The Legal Landscape for Advanced Therapies: Material and Institutional Implementation of European Union Rules in France and the United Kingdom », Journal of Law and Society, Wiley-Blackwell, 2012, n°1
Aurélie Mahalatchimy, Mahalatchimy A, Rial-Sebbag E, Tournay V, Faulkner A, « The legal landscape for advanced therapies: material and institutional implementation of European Union rules in France and the United Kingdom. », Journal of law and society, 2012
Aurélie Mahalatchimy, Emmanuelle Rial-Sebbag, Virginie Tournay, Alex Faulkner, « Does the French Bioethics Law create a 'moral exception' to the use of human cells for health? A legal and organisational issue »: A legal and organisational issue, Dilemata: International Journal of Applied Ethics, 2011, n°7, pp. 17-37
Aurélie Mahalatchimy, « Access to Advanced Therapy Medicinal Products in the EU: Where Do We Stand? », European Journal of Health Law, Brill Academic Publishers, 2011
Aurélie Mahalatchimy, Mahalatchimy A, « Access to advanced therapy medicinal products in the EU: where do we stand? », European journal of health law, 2011
Aurélie Mahalatchimy, « Bioethics and European Union: the Advanced Therapy Medicinal Products’ case », Opinio Juris in Comparatione, 2010
Aurélie Mahalatchimy, « L’harmonisation de l’accès au marché des médicaments de thérapie innovante : entre volonté et réalité », Revue générale de droit médical, Les {\'E}tudes hospitali{\'e}res {\'e}ditions, 2009
Notices / fascicules
Aurélie Mahalatchimy, Blandine Juillard-Condat, « Pharmacovigilance », in Sacha Garben, Laurence Gormley (dir.), The Oxford Encylopedia of EU Law [OEEUL], Oxford University Press, 2026
Aurélie Mahalatchimy, Tamara K. Hervey, « Medicines », in Sacha GARBEN, Laurence GORMLEY (dir.), The Oxford Encylopedia of EU Law [OEEUL], Oxford University Press, 2025
Aurélie Mahalatchimy, Inesa Fausch, « Advanced Therapy Medicinal Products », in Sacha Garben, Laurence Gormley (dir.), The Oxford Encylopedia of EU Law [OEEUL], Oxford University Press, 2025
Aurélie Mahalatchimy, Éloïse Gennet, « Orphan medicines », in Oxford University Press (dir.), Oxford Encyclopedia of EU Law, 2023
Aurélie Mahalatchimy, Florence Taboulet, « Manufacturing and batch testing of medicines », The Oxford Encylopedia of EU Law, 2022
Aurélie Mahalatchimy, Florence Taboulet, « Marketing authorisation of generics, biosimilars, and hybrid medicinal products », The Oxford Encylopedia of EU Law [OEEUL], 2022
Aurélie Mahalatchimy, Florence Taboulet, « Packaging and labelling of medicines », The Oxford Encylopedia of EU Law [OEEUL], 2022
Aurélie Mahalatchimy, Florence Taboulet, « Transparency of medicines pricing », The Oxford Encylopedia of EU Law [OEEUL], 2022
Rapports de recherche
Aurélie Mahalatchimy, Hsin-Yu Kuo, Valentin Roby, Luc-Sylvain Gilbert, Deliverable: D.4.6. Final: hub for research and regulatory communities: Report on development and uptake of a high-quality information source for the research and regulatory communities and patients, supported by increased liaison between researchers, regulators and other stakeholders, and the impact of these actions on ATMP development and on decision making by regulatory and healthcare authorities, 2026
Aurélie Mahalatchimy, Hsin-Yu Kuo, Valentin Roby, Luc-Sylvain Gilbert, Knowledge-sharing function, Report on development of a knowledge-sharing function within www.eurogct.org, 2026
Deliverable 4.5 reports on Task 6, Creation of an online space to promote knowledge sharing among stakeholders. This report provides a summary of all information-sharing functions built on the EuroGCT website, and how the consortium and the wider gene and cell therapy (GCT) communities have been using these functions to date.
Aurélie Mahalatchimy, Hsin-Yu Kuo, Luc-Sylvain Gilbert, Auxane Delage, EuroGCT Deliverable D4.3: Searchable map, Report on development of a searchable map of cell and gene-based therapy activity in Europe, 2025, pp. 1-12
Aurélie Mahalatchimy, Hsin-Yu Kuo, Luc-Sylvain Gilbert, Auxane Delage, EuroGCT Deliverable D2.9: Update on Research and Regulatory Hub, 2025, pp. 1-16
Aurélie Mahalatchimy, Auxane Delage, Luc-Sylvain Gilbert, Hsin-Yu Kuo, EuroGCT, D2-2: Research community hub, a report on dissemination and uptake of information produced in WP4 via the EuroGCT online research and regulatory community hub, 2023
EuroGCT WP4 develops an information hub for the research and regulatory communities that facilitates access of these communities to information on the practical steps needed for cell and gene-based therapy development and promotes information exchange within and between these communities. This tailored section of www.eurogct.org aims to create a ‘one-stop shop’ on where to seek further information and guidance relating to manufacturing guidelines, regulatory requirements, intellectual property rights, market acceptability and ethical matters related to advanced therapies development. Report D2.2 summarises the activities performed regarding the dissemination and uptake of information produced in WP4 between month 12 (since the launch of the new website) and month 30.
Aurélie Mahalatchimy, Hsin-Yu Kuo, Luc-Sylvain Gilbert, Auxane Delage, EuroGCT D4-2: Resources on practical steps- a set of information resources on the practical steps needed for cell and gene therapy development, 2023
The European Consortium for Communicating Gene and Cell Therapy Information (EuroGCT) has two major objectives: • To provide patients, people affected by conditions, healthcare professionals and citizens with accurate scientific, legal, ethical and societal information and with engagement opportunities, and thus to support better informed decision-making related to cell and gene-based therapies. • To facilitate better decision-making at key points in development of new therapies and thus enable improved product development, by providing the research community and regulatory and healthcare authorities with an information source on the practical steps needed for cell and gene therapy development. Work Package 4 (WP4) is developing an information hub for the research and regulatory communities that facilitates access of these communities to information on the practical steps needed for cell- and gene-based therapy development and promotes information exchange within and between these communities. Deliverable 4.2 is a set of information resources on the practical steps needed for cell and gene therapy development, which can be viewed online at www.eurogct.org/researchpathways.
Aurélie Mahalatchimy, Hsin-Yu Kuo, Luc-Sylvain Gilbert, Auxane Delage, EuroGCT D4-1: Landscape mapping, report on mapping of European cell and gene therapy landscape at multiple levels, 2023
Deliverable 4.1 is a report on the mapping of the European gene-based and cell therapies landscape. This deliverable provides an update to the earlier deliverable, D.4.8 Initial Landscape Mapping, which was submitted in the first reporting period. D4.8 reported the mapping, performed by EuroGCT, of the European landscapes associated with gene and cell therapy related product development pathways including ethical, legal, regulatory and societal issues (ELSI). Related, D4.7 Information collation, also submitted in the first reporting period, detailed our methodology for information collection and curation. The work reported in D4.7 and D4.8 resulted in creation of a development framework for a practical tool entitled “Development pathways for bringing gene and cell therapies from the lab to patients” with the short website name of “Research Pathways” (see D4.8). This tool was organised as a Web tree, into which general information on the development pathways for bringing gene and cell therapies from the lab to patients (hereafter the “Research Pathways Tree”) was organised. The Research Pathways Tree also included the organised information (mapping/inventory of information) of the practical steps required for cell and gene therapy development in Europe as well as links on relevant and existing information and guidance. The present report, D4.1, therefore moves beyond the initial mapping to focus on implementation of these processes. This has required a combination of actions: Identification of the detailed information required to populate the Research Pathways Tree was described in D4.8; in this reporting period, we have: 1) created original EuroGCT resources around development pathways for bringing gene and cell therapies from the lab to patients, the Research Pathways Tree (see D4.8 Annex 1 for details), 2) co-developed resources through collaboration, 3) selected and signposted to existing high quality resources (based on the methodology detailed in D4.7), and 4) launched an updated ‘Research Pathways’ database featuring improved navigability and information organisation. In the following sections, we provide the details of each action we have taken, our thought processes and some challenges we have come across. The outputs are published on the EuroGCT website in the Research Pathways section (www.eurogct.org/research-pathways) as a searchable and filterable database and will continually be updated throughout the course of the project. (See also: D4.2).
Aurélie Mahalatchimy, Hsin-Yu Kuo, Luc-Sylvain Gilbert, Auxane Delage, Anna Couturier, EuroGCT Deliverable D4.7: Information collation, report on collation of existing information and links on where to seek information and guidance- Version 2.0, 2023
Deliverable D.4.7 "Information collation - Report on collation of existing information and links on where to seek information and guidance" describes the methodology and tools used for collecting and selecting information regarding gene and cell therapy development. It focuses on how the information is collated rather than summarising the collated information itself. The published and subsequent output of the methodological reporting in this early-project deliverable is presented in D4.2. The collated information is presented in the EuroGCT website Research Pathways section (https://www.eurogct.org/research-pathways) as a searchable and filterable database. New content developed by the EuroGCT project and signposting to additional collated resources is now continually incorporated into this database, and this will continue throughout the duration of the project. The overall objective of WP4 is to develop an information hub for the research and regulatory communities, facilitating their access to high-quality information on the practical steps needed for cell and gene-based therapy development at each stage of the product development process. This deliverable, on the means of information-gathering, constitutes the foundation of all information provision by WP4. It forms the basis of all deliverables within WP4, from past deliverables (D4.4 Regulator Engagement Strategy, D4.8 Initial Landscape Mapping, and D4.9 Initial Information on Practical Steps) to deliverables due now (D4.1 Landscape Mapping, and D4.2 Resources on Practical Steps), and future deliverables (D4.3 Searchable Map, D4.5 Knowledge Sharing Function, and D4.6 Hub for the Research and Regulatory Communities). How the information is collated feeds into what information is selected, information quality and whether it meets the needs of the stakeholders. It therefore affects every output from WP4. For this reason, it is of fundamental importance to report on the details of the approaches we have taken. The field of gene and cell therapy is rapidly advancing, and so is the relevant scientific and legal information. The EuroGCT WP4 has been and will continue to review and update our methodology for collecting this information throughout the project span. Updates within the current reporting period have been reflected in this report within relevant sections and annexes.
Aurélie Mahalatchimy, Éloïse Gennet, Mbathie Mbengue, Perron Martine, I-BioLex Deliverable D9-1-2.0: Data Management Plan, 2023
Aurélie Mahalatchimy, Eloïse Gennet, Mbathie Mbengue, Perron Martine, I-BioLex Deliverable D9-1: Data Management Plan version 2.0, 2023
Aurélie Mahalatchimy, Éloïse Gennet, Markus Frischhut, Pin Lau, Health as a fundamental value. Towards an inclusive and equitable pharmaceutical strategy for the European Union, 2022
On behalf of the Interest Group on Supranational Biolaw of the European Association of Health Law (EAHL IG Biolaw) and the I-BioLex research project (ANR-20-CE26-0007-01), Éloïse Gennet and Aurélie Mahalatchimy have been coordinating, since September 2021, the thematic network on the pharmaceutical strategy on the European Health Policy Platform (EUHPP) of the European Commission. The thematic network of the EAHL IG Biolaw, selected by the European Commission and by the users of the EUHPP platform, is entitled “Health as a fundamental value. Towards an inclusive and equitable pharmaceutical strategy for the European Union”. This network enables to link the EAHL IG Biolaw, exclusively constituted by researchers and academics in the field of health law in Europe, on the one hand with the European Commission and in particular DG Health, and on the other hand with socio-economic actors interested in EU law applicable to medicinal products and medical devices (patient representatives, representatives of health professionals or non-governmental organizations in the field of health). After several months of fruitful exchanges, the final joint statement which was very favorably received by DG Health and endorsed by several organizations (including the President of Aix-Marseille University and the CNRS) has been presented at the EU Health Policy Platform Annual Meeting 2022 at the European Commission and published on the EUHPP in May 2022.
Aurélie Mahalatchimy, Luc-Sylvain Gilbert, Edouard Habib, Amanda Waite, EuroGCT Deliverable D4.4: Regulator Engagement Strategy, 2022, pp. 1-59
Aurélie Mahalatchimy, Edouard Habib, Luc-Sylvain Gilbert, Amanda Waite, EuroGCT Deliverable D4. 8: Initial landscape mapping, 2022, pp. 1-86
Aurélie Mahalatchimy, Edouard Habib, Luc-Sylvain Gilbert, Hsin-Yu Kuo, Éloïse Gennet, EuroGCT Deliverable D4.7: Information collation, 2022, pp. 1-87
Aurélie Mahalatchimy, Hsin-Yu Kuo, Amanda Waite, EuroGCT Deliverable D4.9: Initial information on practical steps, 2022
Aurélie Mahalatchimy, Éloïse Gennet, Mbathie Mbengue, I-BioLex Deliverable D9-1: Data Management Plan, Version 1.0, 2021
Le projet ANR JCJC AAPG 2020 I-BioLex ‘Fragmentation et défragmentation du droit des innovations biomédicales’ est porté par Aurélie Mahalatchimy, chargé de recherche en droit au CNRS, au sein de l’UMR 7318 DICE CERIC, CNRS-Aix-Marseille Université-Université de Pau et des Pays de l’Adour-Université de Toulon et du Var. Ce projet de 4 ans (2021-2024) vise à étudier les processus de fragmentation et de défragmentation du droit européen applicable aux innovations biomédicales (principalement thérapie génique, médecine régénératrice et nanomédecine). Ce rapport a pour objectifs de montrer comment, tout au long du projet I-BioLex et après, les données issues de ce projet sont gérées : - Selon des bonnes pratiques concernant notamment la collecte, le stockage, la documentation, etc… - Dans le respect des exigences éthiques et juridiques relatives à la protection et la diffusion des données, aux conditions de partage et aux modalités de réutilisation, etc… - Dans le respect des principes FAIR (Facile à trouver, Accessible, Interopérable, Réutilisable) - Selon une approche visant à faciliter les échanges entre les collaborateurs du projet - Selon une approche d’anticipation des besoins afin de gagner du temps pour les publications et la valorisation des résultats.
Autres publications
Aurélie Mahalatchimy, Tamara K. Hervey, Marie Glinel, How should we understand the European Union's Court's decisions about 'substances of human origin'?, lay-summary of the paper “Understanding European Union SoHO caselaw through defragmentation and fragmentation” published in the European Journal of Health Law, EuroGCT website, May 2026., 2026
Aurélie Mahalatchimy, Inesa Fausch, High-level analysis of European Union law on Advanced Therapy Medicinal Products, lay-summary of an academic online encyclopaedia published by Oxford University Press (The Oxford Encyclopedia of EU Law (OEEUL)), EuroGCT website, May 2026., 2026
Aurélie Mahalatchimy, Adrien Bottacci, Guylène Nicolas, Travail préparatoire à une revue de littérature sur les aspects juridiques des organoïdes, 2026
Aurélie Mahalatchimy, Valentin Roby, A Booklet of I-BioLex posters, 2025
From 1st January 2021 to 31 October 2025, the I-BioLex members and other colleagues have produced 26 posters that have been presented in International and European congresses in France and abroad. These posters are parts of the analysis conducted on fragmentation (division or segmentation), and defragmentation (gathering together, connecting or ‘harmonising’) of the European law on Biomedical innovations, regarding biological medicines and their subcategories, Advanced Therapy Medicinal Products and their subcategories, and orphan medicines. They relate to the various topics presented below in the table of contents.
Aurélie Mahalatchimy, Tamara K. Hervey, Interview with Tamara K. Hervey – EU health law in the UK: From the past to the present, and towards the future, DICE Editions, 2024, pp. -3591
In this interview, Professor Tamara K. Hervey, a leading academic scholar on European Union health law, answers a range of questions about her personal experience of teaching and researching this branch of law in the only country to have left the European Union: the United Kingdom. What differences are there in EU health law teaching and research before and after Brexit? Do comparative law and international law constitute an alternative intellectual home? What has happened to the funding of her research since Brexit? What does she think about the current influences and interactions between EU health law and English health law?
Aurélie Mahalatchimy, Advanced Therapy Medicinal Products: Law in Science a Podcast by Doctor Inesa Fausch on Spotify, 2024
Aurélie Mahalatchimy, Advanced Therapy Medicinal Products, 2024
Aurélie Mahalatchimy, Jean-Christophe Galloux, Post/Trans-humanisme et droits de l’Homme - Dimension économique, 2019
Aurélie Mahalatchimy, Philippe Testard-Vaillant, A. MAHALATCHIMY, interviewée par Philippe Testard-Vaillant, Innovations biomédicales: le droit comme garde-fou, CNRS, 2019
Aurélie Mahalatchimy, Genome editing and the European Union, 2019
Aurélie Mahalatchimy, Alex Faulkner, Conflicting values of biomedical innovation?, 2018
The term 'value' is at the centre of, an increasingly explicit debate in the fields of health and healthcare policy. 'Value' is understood in many different ways and diverging interests are being mobilised. How are values in biomedical innovation being expressed, represented, materialised and aligned or contested in different areas of biomedicine? How do values embedded in regulation, public health, economic policies, healthcare provision, technology assessment, producers' strategies, and patient organisation movements shape biomedical innovations? At an ESOF discussion in Toulouse multidisciplinary perspectives on value between panel members and public participants will be explored and possible pathways to common solutions identified that promote socially acceptable biomedical innovation in the European context.
Aurélie Mahalatchimy, Emmanuelle Rial-Sebbag, Règlementation de la recherche sur les cellules souches en France, 2017
Aurélie Mahalatchimy, Règlementation de la recherche sur les cellules souches au Royaume-Uni, 2017
Aurélie Mahalatchimy, Regulation of stem cell research in the United Kingdom, 2017
Aurélie Mahalatchimy, Emmanuelle Rial-Sebbag, Regulation of stem cell research in France, 2017
Aurélie Mahalatchimy, Forthcoming legislative changes at the European Union level and their potential impact on gene and cell therapy, 2026
Aurélie Mahalatchimy, Valentin Roby, Medical devices containing tissues and cells, 2026
Aurélie Mahalatchimy, Valentin Roby, Medical devices containing human cells or tissues/SoHO, 2026
Aurélie Mahalatchimy, Valentin Roby, Medical devices containing animal cells or tissues, 2026
Aurélie Mahalatchimy, Valentin Roby, Obligations applicables au fabricant de dispositifs médicaux, 2026
Aurélie Mahalatchimy, Luc-Sylvain Gilbert, Edouard Habib, Clinical trials for ATMPs, 2026
Aurélie Mahalatchimy, Luc-Sylvain Gilbert, Pharmacovigilance of ATMPs, 2026
Aurélie Mahalatchimy, Human body elements for human applications / EU Regulation 2024/1938 on substances of human origin intended for human application, EuroGCT website, 2026
Aurélie Mahalatchimy, Noémie Dubruel, In silico studies (digital models/digital twins): In silico studies (digital models/digital twins), 2026
Aurélie Mahalatchimy, Adrien Bottacci, Les recherches sur les collections d’échantillons biologiques humains : la place centrale des biobanques, 2026
Aurélie Mahalatchimy, Luc-Sylvain Gilbert, Genetically Modified Organisms-based Advanced Therapy Medicinal Products, Open access on EuroGCT website, 2026
Aurélie Mahalatchimy, Auxane Delage, Support from National medicines Agencies for the development of innovative medicines at the National levels, Open access on EuroGCT website, 2026
Aurélie Mahalatchimy, Auxane Delage, Support from several competent authorities for the development of innovative medicines, EuroGCT website, 2026
f) Early interactions with Competent authorities
Aurélie Mahalatchimy, Noémie Dubruel, In silico studies (digital models/digital twins), 2026
Aurélie Mahalatchimy, Adrien Bottacci, Anna Couturier, Auxane Delage, Glossary of terms in gene and cell therapy, 2025
Aurélie Mahalatchimy, Christian Chabannon, ATMPs specific Hospital exemption pathway, 2025
Aurélie Mahalatchimy, Luc-Sylvain Gilbert, Bonnes Pratiques de Fabrication des médicaments de thérapie innovante, 2025
Aurélie Mahalatchimy, Auxane Delage, CAT scientific recommendations on classification, 2024
Aurélie Mahalatchimy, “Compassionate use” and “named-patients basis” pathways for ATMPs, 2024
Aurélie Mahalatchimy, Valentin Roby, Public Involvement  and Data/ Données, 2024
Aurélie Mahalatchimy, Valentin Roby, Public Involvement and Data/Data, 2024
Aurélie Mahalatchimy, Luc-Sylvain Gilbert, Accès au marché pour les médicaments de thérapie innovante/ Accélération des Procédures d'autorisation de mise sur le marché, 2024
Aurélie Mahalatchimy, Audrey-Claire Ruiz, Luc-Sylvain Gilbert, Prix et prise en charge des médicaments en France : Introduction et parties prenantes, 2024
Aurélie Mahalatchimy, EuroGCT Consortium, Who should use EuroGCT’s key resources, and how to use them?, EuroGCT website, 2024
Aurélie Mahalatchimy, Consortium EuroGCT, How to use Research Pathways, EuroGCT website, 2024
Aurélie Mahalatchimy, EuroGCT consortium, About EuroGCT’s Key Resources, EuroGCT website, 2024
Aurélie Mahalatchimy, Luc-Sylvain Gilbert, Manufacturing Authorisation of ATMPs, 2024
The manufacture of medicinal products in the European Union (EU) is subject to manufacturing authorisation. Any legal entity, generally a company, wishing to manufacture a medicinal product must hold a manufacturing authorisation issued by the national competent authority of the Member State where they carry out these activities. To obtain a manufacturing authorisation, all medicinal products for human use intended for the EU market must be produced in accordance with EU quality standards: Good Manufacturing Practice (GMP) principles and guidelines, and the European Pharmacopeia. The manufacturers are also obliged to have a qualified person responsible for ensuring that the requirements adopted for the manufacturing authorisation and the applicable legislation are respected. Ensuring the quality of medicines is a criterion to obtain marketing authorisation and corresponds to Module 3 of the Marketing Authorisation Application dossier, "Chemical, pharmaceutical, and biological documentation" (Chemistry, Manufacturing and Controls -CMC) that aims to determine the specifications capable of guaranteeing the reproducibility of the medicine’s composition. This stage is particularly challenging for Advanced Therapy Medicinal Products (ATMPs) regarding their level of complexity (especially for manufacturing processes) and their specific characteristics, especially the use of substances of human origin such as blood, tissues and cells, and the reproducibility when using live biological samples. That is why, Guidelines on GMP specific to ATMPs have been published in 2017 by the European Commission, in accordance with Article 5 of Regulation (EC) No 1394/2007.
Aurélie Mahalatchimy, Luc-Sylvain Gilbert, Autorisation de fabrication des médicaments de thérapie innovante, 2024
La fabrication de médicaments dans l'Union européenne (UE) est soumise à une autorisation de fabrication. Toute personne morale, généralement une entreprise, souhaitant fabriquer un médicament doit détenir une autorisation de fabrication délivrée par l'autorité nationale compétente de l'État membre dans lequel elle exerce ces activités. Pour obtenir une autorisation de fabrication, tous les médicaments à usage humain destinés au marché de l'UE doivent être produits conformément aux normes de qualité de l'UE : principes et lignes directrices des Bonnes Pratiques de Fabrication (BPF) et Pharmacopée européenne. Les fabricants sont également tenus d'avoir une personne qualifiée chargée de veiller au respect des exigences requises par l'autorisation de fabrication et la législation applicable. Garantir la qualité des médicaments est un critère d'obtention de l'autorisation de mise sur le marché et correspond au module 3 du dossier de demande d'autorisation de mise sur le marché, « Documentation chimique, pharmaceutique et biologique » (Chemistry, Manufacturing and Controls -CMC) qui vise à déterminer les spécifications capables de garantir la reproductibilité de la composition du médicament. Cette étape est particulièrement délicate pour les Médicaments de Thérapie Innovante (MTI) en raison de leur niveau de complexité (en particulier des procédés de fabrication) et de leurs caractéristiques spécifiques, notamment l'utilisation de substances d'origine humaine telles que le sang, les tissus et cellules, et la reproductibilité lors de l'utilisation d'échantillons biologiques vivants. C'est pourquoi des lignes directrices sur les BPF spécifiques aux MTI ont été publiées en 2017 par la Commission européenne, conformément à l'article 5 du Règlement (CE) n° 1394/2007.
Aurélie Mahalatchimy, Luc-Sylvain Gilbert, Good Manufacturing Practice for ATMPs, 2024
Under European Union (EU) law, the manufacture or import of medicinal products in the European Union is subject to manufacturing or import authorisation. Any company wishing to manufacture a medicinal product must hold a manufacturing authorisation issued by the national competent authority of the Member State where they carry out these activities. To obtain a manufacturing or import authorisation, all medicinal products for human use intended for the European Union market must be produced in accordance with EU Good Manufacturing Practice (GMP) principles and guidelines. GMP is a code of quality standards concerning the manufacture, processing, packing, release and holding of a medicinal product placed within the European Economic Area. GMP describes the minimum standard that a medicines manufacturer must meet in their production and quality control processes, including those involving medicinal products intended for export only and medicines and active substances imported into the EU. GMP is mandatory for all medicinal products that have been granted a marketing authorisation as well as for the manufacture of investigational medicinal products. GMP is also applicable to Advanced Therapy Medicinal Products (ATMPs). However, regarding the level of complexity and the specific characteristics of ATMPs (use of substances of human origin such as blood, tissues and cells), the European Commission has published in accordance with Article 5 of Regulation (EC) No 1394/2007 on ATMPs, Guidelines on GMP specific to ATMPs. These guidelines provide the GMP requirements that should be applied in the manufacturing of ATMPs that have been granted a marketing authorisation and/or used in clinical trial setting.
Aurélie Mahalatchimy, ATMPs: Applicable regulatory pathways. EuroGCT Website, 2024
Aurélie Mahalatchimy, Luc-Sylvain Gilbert, Procédure d’évaluation accélérée des médicaments de thérapie innovante, 2024
Aurélie Mahalatchimy, Luc-Sylvain Gilbert, Autorisation de mise sur le marché sous circonstances exceptionnelles des médicaments de thérapie innovante, 2024
Aurélie Mahalatchimy, Luc-Sylvain Gilbert, Procédure centralisée pour les médicaments de thérapie innovante, 2024
Aurélie Mahalatchimy, Luc-Sylvain Gilbert, Dossier de demande d'autorisation de mise sur le marché pour les médicaments de thérapie innovante, 2024
Aurélie Mahalatchimy, Luc-Sylvain Gilbert, Emballage et étiquetage des médicaments de thérapie innovante, 2024
Aurélie Mahalatchimy, Luc-Sylvain Gilbert, Autorisation de mise sur le marché conditionnelle les médicaments de thérapie innovante, 2024
Aurélie Mahalatchimy, Auxane Delage, Support specific to ATMPs’ development at EMA level. EuroGCT Website, 2023
Aurélie Mahalatchimy, Advertising of ATMPs, EuroGCT website, 2023
Aurélie Mahalatchimy, Auxane Delage, Early interactions with regulators, 2023
Aurélie Mahalatchimy, Auxane Delage, Early interactions with regulators- Support for innovative medicines’ development, 2023
Aurélie Mahalatchimy, Auxane Delage, Early interactions with regulators: Support for innovative medicines’ development at the EMA level, 2023
Aurélie Mahalatchimy, Auxane Delage, Early interactions with regulators: Support specific to ATMPs’ development at EMA level, 2023
Aurélie Mahalatchimy, Therapy classification: Human body elements for therapeutic applications, 2023
Aurélie Mahalatchimy, Commercialisation: Advertising of ATMPs, 2023
Aurélie Mahalatchimy, Luc-Sylvain Gilbert, Market Access for ATMPs- Expediting marketing authorisation pathways, 2023
Aurélie Mahalatchimy, Luc-Sylvain Gilbert, Conditional Marketing Authorisation of ATMPs: Market Access for ATMPs- Expediting marketing authorisation pathways, 2023
Aurélie Mahalatchimy, Luc-Sylvain Gilbert, Marketing Authorisation under exceptional circumstances for ATMPs, 2023
Aurélie Mahalatchimy, Luc-Sylvain Gilbert, Accelerated Assessment of ATMPs: Market Access for ATMPs- Expediting marketing authorisation pathways, 2023
Aurélie Mahalatchimy, Luc-Sylvain Gilbert, Market Access for ATMPs- Specificities of the marketing authorisation dossier for biosimilars, 2023
Aurélie Mahalatchimy, Luc-Sylvain Gilbert, Accelerated Assessment of ATMPs, 2023
Aurélie Mahalatchimy, Luc-Sylvain Gilbert, Conditional Marketing Authorisation of ATMPs, 2023
Aurélie Mahalatchimy, Luc-Sylvain Gilbert, Market Access for ATMPs- Standard Marketing Authorisation Pathway: Centralised Procedure, 2022
Aurélie Mahalatchimy, Luc-Sylvain Gilbert, Market Access for ATMPs- Standard Marketing Authorisation Pathway: Centralised Procedure/ Marketing Authorisation Application file, 2022
Aurélie Mahalatchimy, Luc-Sylvain Gilbert, Packaging and labelling of ATMPs, 2022
Aurélie Mahalatchimy, EuroGCT Consortium, Relevant Literature Section of EuroGCT's Key Resources. EuroGCT Website, 2022
Communications
Aurélie Mahalatchimy, « Le vivant humain singularisé et le droit de l’Union européenne », Colloque “Le droit du vivant”, Le Mans, le 26 mars 2026
Projet collectif des membres du Themis-UM, laboratoire de recherche en droit, Le Mans Université, sous la direction scientifique de Magali Bouteille-Brigant, Professeure en Droit Privé et Co-Directrice du laboratoire Themis-UM, Le Mans Université
Aurélie Mahalatchimy, Adrien Bottacci, Guylène Nicolas, « Biotechnology as a catalyst for a coherent and embedded EU regulation of bio-based products: the Commission’s proposal for an EU Biotech Act », 10th Conference of the European Association of Health Law, Uppsala Sweden, prévue le 09 septembre 2026
Aurélie Mahalatchimy, Adrien Bottacci, Guylène Nicolas, « How do in vitro gametogenesis and stem cell-based embryo models challenge the prohibition on creating embryos for research purposes? », prévue le 08 juillet 2026
Aurélie Mahalatchimy, « Présentation générale de la règlementation SoHO et de la proposition du Biotech Act (Invitée) », 5ème Rencontre des Intégrateurs en Biothérapies et en Bioproduction, Besançon, le 09 juin 2026
Aurélie Mahalatchimy, Valentin Roby, Christian Chabannon, « Quelles procédures réglementaires pour l’obtention et l’utilisation de cellules humaines destinées à la recherche biomédicale ? », le 03 juin 2026
Aurélie Mahalatchimy, Auxane Delage, Luc-Sylvain Gilbert, Valentin Roby, « Tracking back innovation in different classes of newly-developed medicinal products through the linkage between Nobel and Galien prizes supports a specific status for advanced therapies. An iBioLex project », le 06 mai 2026
Aurélie Mahalatchimy, « What are the expected legislative changes within the EU regarding gene-editing technologies? », Addressing Regulatory, Technological-transfer and Industry Aspects in GenE-HumDi, Paphos Cyprus, le 21 avril 2026
Aurélie Mahalatchimy, Hsin-Yu Kuo, Heather Love, Luc-Sylvain Gilbert, « Tracking back innovation in different classes of newly-developed medicinal products through the linkage between Nobel and Galien prizes supports a specific status for advanced therapies », 52nd EBMT Annual Meeting, GoCART Coalition Session on “The Power of Real-World Education and Real-World Data”, Madrid & Virtual Spain, le 22 mars 2026
Background: Gene and cell therapies (GCTs) face various communication and comprehension challenges when transitioning from bench to bedside. These challenges include complex science, regulation, and ethics, impacting clinical adoption and the GCTs sector. Moreover, the challenges are often exacerbated by misinformation and voices dominated by AI-mediated search platforms owned by tech giants. Methods: The EuroGCT consortium was built through connecting 47 European partner organisations including academic institutions, learned societies, national centres of excellence, and patient organisations. Funded by the European Commission, the consortium has created a network of expertise and an online information hub that focusses on the pivotal role of science communication in navigating the complexities of therapy development and public comprehension. It is dedicated to demystifying GCTs as it extends beyond the laboratory and enters the realms of broader societal impact. We began from the position that digital spaces – particularly search engines like Google – create the backbone of the informational environments that inform non-expert interactions. Through targeted science communication initiatives, building and updating our information hub at www.eurogct.org, we explore the significance of engaging with diverse stakeholders, including patient advocacy groups, regulators, clinicians, developers, media, bioethicists, social scientists, artists, computer scientists, and the public at large. By fostering two-way dialogue and disseminating accessible information including explainers, factsheets, films, and educational material, we empower these stakeholders as they search for high quality referential information online. Through implementing self-developed, research-led search engine optimisation and metadata enhancements, we improve EuroGCT resources’ visibility in search engines and generative AI searches. By fostering engagement, promoting transparency, and advocating for collaborative resource development, EuroGCT endeavours to realise the full potential of these transformative treatments to improve health outcomes while contributing to a fair and equitable society. Results: EuroGCT is a common information hub for pre-competitive, international and interdisciplinary collaboration to address pressing concerns faced by our research community as well as the patients and publics. To empower the public and patient stakeholders to actively and effectively participate in shaping the trajectory of GCT development, we have developed accurate and accessible information explaining the science, the ethical and social impact in the Discover section of the hub. To help stakeholders interested in developing GCTs navigate the complex pathways bringing therapies from lab to patients, the Research Pathways section facilitates their access to information on practical steps needed at each stage of product development. Our results extend beyond the boundaries of public facing information to address key considerations in all stages of therapy development, such as regulatory frameworks, accessibility, and equitable access. Website traffic and search engine (including AI search) integration demonstrate EuroGCT's success in achieving its objectives. Conclusions: The EuroGCT consortium's work underscores the critical importance of collective science communication in driving responsible and inclusive translation of gene and cell therapies beyond the laboratory through accessible information. EuroGCT’s information hub is an established common tool for all European stakeholders.
Aurélie Mahalatchimy, « Des frontières en mouvement: la fragmentation et la défragmentation du droit européen des innovations biomédicales », Aux frontières du droit de la santé, Aix-en-Provence, le 20 novembre 2025
Colloque organisé par l'UMR DICE, le CERIC, Aix-Marseille Université et le CDSA, l'ADES, Sciences Po Aix et l'IUF sous la direction scientifique d'Estelle Brosset, Professeure, membre de l’Institut Universitaire de France (UMR DICE, CERIC) et Guylène Nicolas, Professeure, Vice-Présidente déléguée à la formation tout au long de la vie (UMR ADES, CDSA)
Aurélie Mahalatchimy, Adrien Bottacci, Guylène Nicolas, « Obtaining cells for biomedical research and innovative therapies: which regulatory pathways in France? », le 17 novembre 2025
Objective: Human cells procurement is the basis of biomedical research and, consequently, of the production of innovative therapies. In France, multiple procedures apply and overlap, which results in a complex regulatory landscape. The objective of this work is to provide a clear overview of the existing regulatory pathways for cell procurement, to assist stakeholders in navigating these various procedures and identifying easily the one most relevant to their respective cases. Methods: First, we identified the relevant legal texts and their specific provisions that cover the procurement of human cells. Second, taking into account the identified relevant academic literature, we analysed them to determine the applicable legal frameworks as well as the areas of uncertainty that need clarification. Third, we used graphical representations to improve the accessibility of these applicable procedures. Results: An array of procedures governs the use of human cells, depending on the source of the cells, the activities conducted with them, and the type of finished product. In certain contexts, multiple procedures may overlap. Although some existing resources explain each procedure individually, it remains challenging to identify all relevant frameworks applicable to specific activities. This issue is even more salient for (stem) cells researchers who must implement them to conduct their activities. While there are calls to simplify some of these frameworks by relying more on the accountability of actors, there has been no clear signal of legislative change in the near future. Conclusion: While the French regulatory approach is complex, it is rooted in a strong ethical commitment, with particular attention paid to ethical issues in the bioethics law. However, this traditional stance has been increasingly challenged by international pressure to develop a more competitive research environment. As a result, the French legal framework for human cell procurement and biomedical use is shaped by this tension between ethical caution and the drive to increase competitiveness. Whether the ongoing calls for reform will translate into substantive changes remain a question of public and policy discussion.
Aurélie Mahalatchimy, Tamara K. Hervey, Marie Glinel, « Fragmentation and Defragmentation in EU Law on Innovative Biomedicine: Revealing Dialectic Mechanisms of Legal Integration », Workshop “Fragmentation and defragmentation of the law on biomedical innovations”, Amsterdam Netherlands, le 30 octobre 2025
Aurélie Mahalatchimy, « Introduction and Chairing of the EuroGCT Workshop on “Is the EU Regulation on HTA Enhancing Equitable Access to Innovative Medicines in Europe? A EuroGCT workshop” », Building Bridges for Medicines Justice, Amsterdam Netherlands, le 28 octobre 2025
This workshop addresses the challenges of ensuring patient access to Advanced Therapy Medicinal Products (ATMPs) in the EU, where high costs and national-level reimbursement decisions create inequalities despite centralised marketing authorisation. Product withdrawals have occurred due to commercial reasons. Key obstacles include diverse Health Technology Assessment (HTA) methods and varying tolerance for uncertainty. The 2021 EU HTA regulation, effective January 2025 for ATMPs and cancer medicines, aims to support Member States in taking timely and evidenced-based decisions for patients’ access to health technologies. The workshop explores opportunities and challenges of implementing HTA at both European and National levels. This workshop is part of the Regulatory Engagement Strategy of the European project EuroGCT (European Consortium for Communicating Gene and Cell Therapy Information), which aims to promote exchanges between stakeholders and regulators.
Aurélie Mahalatchimy, Auxane Delage, Luc-Sylvain Gilbert, « Introduction and chairing of the EuroGCT Lunchtime Symposium on Policy and regulatory strategies: current and prospective impact on gene and cell therapy development », Regulatory Frameworks and Clinical Applications in Gene Editing: Formulating Guidelines and Industrial Agreements, Sevilla Spain, le 07 octobre 2025
Since the publication of the European Regulation (No. 1394/2007) on Advanced Therapy Medicinal Products (ATMPs) in 2007, innovative therapies based on genes, cells, or tissues have reshaped the pharmaceutical landscape. While offering significant opportunities for economic and medical advances, their complex manufacturing raises specific issues on quality and regulatory issues. Detailed guidelines on Good Manufacturing Practices (GMP) specifically tailored to ATMPs have been adopted by the European Commission and have been enforceable since 2017. They address new technological developments, scientific advances, and more suitable production and distribution pathways. To date, 27 ATMPs have obtained a marketing autorisation in Europe, but most are still at the clinical trial stage although they could provide very promising options for addressing unmet medical needs. Making ATMPs accessible to patients remains challenging due to factors such as high cost, the specialized nature of ATMPs manufacturing including stringent safety and efficacy. Moreover, current healthcare infrastructures often require substantial adaptations to accommodate the logistical demands of these treatments.The Hospital Exemption (HE) is a regulatory provision of the European Regulation, that allows the use of certain ATMPs without formal central marketing authorization provided specific criteria are met: a medical prescription for an individual patient, a use within the same Member State, in a hospital setting under the exclusive responsibility of a medical practitioner, a GMP compliant manufacturing. HE implementation and oversight are regulated at the national level by the competent authority of each EU Member State. It provides a practical solution for bypassing the lengthy centralized authorization and facilitating timely access to innovations stemming from academic research and hospital initiatives. In France, a significant regulatory evolution in the field of ATMPs has been recently introduced by the decree on February 16, 2022, pursuant to French Law No. 2021-1017. It establishes a sub-exemption mechanism within the broader HE framework, specifically designed to address the practical challenges of certain ATMPs derived from autologous cells or tissues and involving no substantial manipulation. It authorizes the preparation, distribution, and administration of ATMPs, within the same medical procedure as the procurement of autologous tissues or cells used in their composition, without requiring a specially authorized manufacturing establishment, providing prior validation by the French National Agency for Medicines Safety (ANSM). By formalizing a legal framework for decentralized, bedside production, the decree aligns regulation with the practical realities of personalized medicine, favors more agile healthcare organization and fasters patient access. We aim to present and discuss the first application of this innovative regulatory framework within the MICROPREP III clinical trial (EudraCT No 2023-507683-40). This trial is designed to evaluate in 180 patients the efficacy of intra-articular injections of autologous microfat, optionally combined with autologous platelet-rich plasma (PRP), as an adjunctive therapy for patients with Knee osteoarthritis. The application of the single-step autologous ATMPs exemption needed to implement new measures and agreements between clinicians and manufacturer to ensure compliance to GMP guidelines and ATMPs quality remaining under the responsibility of the authorized establishment despite delocalization.
Aurélie Mahalatchimy, « Présentation de l’article “Mapping the European landscape and specificity of ATMPs guidance », Comité d’interface dédié aux médicaments de thérapie innovante, Paris, le 03 octobre 2025
Aurélie Mahalatchimy, « Human Genome Editing for Therapy & EU Law », CIVIS Blended Intensive Programme: science, ethics & governance of human genome editing, University of Tübingen Germany, le 19 juillet 2025
Aurélie Mahalatchimy, « The fragmented regulatory landscape of human genome editing », CIVIS Blended Intensive Programme: science, ethics & governance of human genome editing, Online, le 03 juillet 2025
Aurélie Mahalatchimy, Auxane Delage, Luc-Sylvain Gilbert, Hsin-Yu Kuo, « Real access to ATMPs: the cost issue », le 22 octobre 2024
While industry developed and manufactured Advanced Therapy Medicinal Products (ATMPs) benefit from a centralised marketing authorisation procedure that allows commercialization in all Member States of the European Union (EU), and despite improvement in EU citizen access to ATMPs being stated as one of the two major objectives when the ATMP regulation was released, actual patient access to ATMPs remains one of the most challenging issues to be addressed. Prices of ATMPs are among the highest despite difficulties in proving long term efficacy on significant numbers of patients, although it is fair to acknowledge that cumulative costs of supportive and curative treatments that are administered on repeated occasions may fall in the same ranges. Publicly accessible data show prices that vary from several hundreds of thousands euros to several million euros per treatment, with a continuous trend in increasing prices that has fuelled the concept of “financial toxicity” for those and other categories of treatments. Payment and reimbursement mechanisms as well as decisions on the levels of healthcare expenditures are established at national and possibly in some countries at regional levels by Heathcare Technology Assesment (HTA) agencies and other governmental bodies, with limited possibilities at the European level. Indeed, mainly apart from the Transparency directive and the recently strengthened collaboration in the field of HTA thanks to the adoption of the HTA regulation following the HTA initiatives at the EU level, each Member States is sovereign in determining its health expenses, including to decide on the reimbursement of ATMPs by its National health insurance system. Actual prices paid by public or private payers are not public, and a significant rebate may result from prior and mutual negotiations between drug manufacturers and healthcare providers, the latter receiving reimbursement from health insurers. In addition, specific programs such as the “Early Access” (“Accès précoces”) program in France may speed up access to innovative treatments in some countries, thus favouring a category of EU citizens over others. Thus, actual patient access to ATMPs in the European Union is not only limited, but also heterogeneous, highlighting the existing gap between the intentions stated in the ATMP Regulation and other EU documents and the actual achievements; these diverse factors resulting in an unsatisfactory situation where patients in need of lifesaving treatments face a shortage on a day-to-day basis, not because of insufficient manufacturing capacities as is the case for low-cost drugs, but because of insufficient payment capacities. This poster first provides an overview of the known prices of the 26 ATMPs that have so far obtained a marketing authorisation in the EU. It also highlights what is regulated at the EU and at the National levels in this area. Finally, it suggests potential solutions to improve patients’ access to ATMPs.
Aurélie Mahalatchimy, Marissa Lithopoulos, Amy Zarzecny, « The rise of the secretome: A comparative analysis of the governance of secretome-based interventions between Canada and the European Union », European Association of Health Law 2024, Warsaw (POLAND) Poland, le 18 septembre 2024
Medicinal products based on genes, cells and tissues of human or animal origin are being developed to treat severe diseases that conventional treatments have failed to treat or that have no available and satisfactory treatments, such as rare, genetic, or neurodegenerative diseases. The risks they raise as innovative and complex medicines but also the therapeutic promises they offer have led to their specific regulation as Advanced Therapy Medicinal Products (ATMPs) in the European Union (EU). Indeed, they are especially submitted to the centralised procedure of Marketing Authorisation (MA) issued by the European Commission. This procedure aims not only to ensure high quality, safety and efficacy for ATMPs with a positive risk-benefit balance to be commercialised, but also a wide access to these medicines for EU patients. Nevertheless, this procedure alone is not always sufficient to allow the commercialisation of ATMPs, and many of them require expediting pathways or regulatory support schemes for innovative medicines to be commercialised. From the adoption of the EU regulation, 25 ATMPs have been granted a MA in the EU. Although there has been a clear increase in approvals from 2018, MA has been withdrawn or not renewed for 7 of them. Starting from the centralised procedure as the strongest and first legal procedure for the widest and safest patients access to these innovative medicines, this poster will provide an overview of the European MA expediting pathways and of their use, for ATMPs to be accessible, and discuss the challenges of their quick but safe commercialisation.
Aurélie Mahalatchimy, « Roundtable on “Accelerating Cell and Gene Therapy Innovation: Regulatory Pathways in Europe” », Advanced Therapies Europe 2024, Estoril (Portugal) Portugal, le 10 septembre 2024
Aurélie Mahalatchimy, « Human Genome Editing for Therapy & EU Law », CIVIS Blended Intensive Programme: science, ethics & governance of human genome editing, University of Tübingen Germany, le 20 juillet 2024
Aurélie Mahalatchimy, « The fragmented regulatory landscape of human genome editing », CIVIS Blended Intensive Programme: science, ethics & governance of human genome editing, Online, le 09 juillet 2024
Aurélie Mahalatchimy, Éloïse Gennet, « Medicines, Medical Devices », Framing EU Health Law through Connectivity, I-BioLex in collaboration with UK-FR Partnership “European Union Health Law and Policy” (PI: M. Flear), and E. Gennet’s Junior Professor chair in European Health law and Medicines,, Aix-en-Provence, le 31 mai 2024
Anna Couturier, Hsin-Yu Kuo, Jennifer Lorigan, Auxane Delage, Luc-Sylvain Gilbert, « Impact Beyond the Lab:the European Consortium for Communicating Gene and Cell Therapy Information (EuroGCT) », le 27 mai 2024
Aurélie Mahalatchimy, Christian Chabannon, « The institutional genealogy of the processes of fragmentation and defragmentation of the European law of biomedical innovations », 3rd Project Meeting and 2nd SAG Meeting, Aix-en-Provence, le 10 avril 2024
Aurélie Mahalatchimy, Eloïse Gennet, « Biomedical innovations in EU non- binding law », Workshop I-BioLex on “Definitions and regulatory concepts in biolaw”, Aix-en -Provence, le 09 avril 2024
Aurélie Mahalatchimy, « De la sécurité à l'accès aux médicaments biologiques: les nouveaux enjeux prioritaires du biodroit de l'Union européenne », Quel modèle pour le biodroit de l’Union européenne ?, Nancy, le 14 mars 2024
Aurélie Mahalatchimy, « La recherche sur l’embryon et les cellules souches embryonnaires, Conférence de l'Université Pour Tous », La recherche sur l’embryon et les cellules souches embryonnaires, Conférence de l'Université Pour Tous-Cahors, Cahors, le 08 février 2024
Aurélie Mahalatchimy, Fabien Milanovic, Baptiste Moutaud, Cecile Vermot, « Organoids in action: an interdisciplinary approach in social sciences (Organact) », le 29 janvier 2024
Aurélie Mahalatchimy, « L'expertise internationale dans les domaines de la santé et de l'environnement », L'expertise internationale dans les domaines de la santé et de l'environnement, Aix-en-Provence, le 28 juin 2023
Organisée par le Centre d'études et de recherches internationales et communautaires (UMR 7318 DICE CERIC) et le Centre de Droit de la Santé (UMR 7268 ADES) sous la direction de Aurélie Mahalatchimy et Sophie Gambardella, chargées de recherche CNRS au CERIC (UMR DICE) et Guylène Nicolas, MCF au Centre de droit de la santé - Faculté de droit et de science politique, Université d'Aix-Marseille
Aurélie Mahalatchimy, « Biotechnologies : quelle sagesse collective ? », Biotechnologies : quelle sagesse collective ?, le 11 mai 2023
Cycle de conférences organisées dans le cadre du projet TESaCo
Aurélie Mahalatchimy, Luc-Sylvain Gilbert, « The Marketing Authorisation of Advanced Therapy Medicinal Products under the regulation of the European Union », International Society for Cell & Gene Therapy 2023 Annual Meeting, Paris Palais des congrès, le 31 mai 2023
Genes, cells, and tissues based medicinal products are specifically regulated as Advanced Therapy Medicinal Products (ATMPs) within the European Union (EU) from the adoption of Regulation (EC) n°1394/2007 on ATMPs. Beyond legislative requirements, the complexity and scientific technicity of these medicines, as well as the necessary flexibility to take into account the evolutions and the scientific and regulatory experience gained has led to the development of an important amount of guidelines in the field. These guidelines have mainly been adopted by the European Medicines Agency (EMA), the European regulatory agency especially in charge of the scientific assessment of medicines to be commercialized in the EU. Some of them have also been adopted by the European Commission which grants the final marketing authorization for medicines to enter the EU market. The adoption of EU guidelines involves a public consultation procedure to gather comments from stakeholders and interested parties. Our poster aims at mapping these different actors, and their potential changes over time, to allow for a realistic and concrete portrait of all stakeholders and interested parties involved in the field of ATMPs regarding their European regulation through guidelines. The identification of EU scientific guidelines applicable to ATMPs, and of the actors involved in the consultation process has led to the establishment of a database with over 200 organizations corresponding to fourteen guidelines for which dates of production range from 2008 to 2022. The organizations have been classified by type (Business, Academia, National bodies, etc.), country, and theme of the drafts of guidelines they commented on. This poster especially highlights and discusses which organizations have influenced the adoption of EU scientific guidelines on ATMPs; some of them commenting almost all guidelines in the field while others considered only certain guidelines. Findings concern both the number and quality of stakeholders with the aim to understand over time, what types of organizations from which country have been the most active in answering to guidelines’ consultations, who were the major or more prolific respondents, and what themes were more often commented.
Aurélie Mahalatchimy, « La loi française relative à la bioéthique : évolutions et démocratisation, Conférence de l'Université Pour Tous », Où en est la loi française sur la bioéthique ?, Cahors, le 16 février 2023
Aurélie Mahalatchimy, Anaëlle Scheer, Valentin Brunel, Simon Guion, Indra Chiv, « The challenges of Advanced Therapy Medicinal Products manufacturing in the European Union: Strengths and limits of current regulatory tools », le 24 octobre 2023
Many actors influence the framing of EU legislation and regulation applicable to gene and cell therapy. Nevertheless, one can wonder how much their activity is focusing on gene and cell therapy or whether it is part of a wider set of activities taking place in the more general theme of biomedical innovation. From an identification of the actors involved in the public consultation process of adoption of Regulations on Advanced Therapy Medicinal Products, on substances of human origin, and of guidance applicable to ATMPs, a few of them have been selected in order to conduct more specific analysis. Our selection process for this pilot analysis included the following criteria: European level organisation, degree of the involvement in the above-mentioned consultation processes, combination between organisations the names of which imply either a very specific or a general remit. Another choice has been to include European organisations particularly relevant for pharmacists, as professionals involved all along the medicinal products’ life cycle. It resulted in a set of 13 European organisations: 5 business associations (Medtech Europe, European Federation of Pharmaceutical Industries and Associations, European Biopharmaceutical Enterprises, European Associations for Bioindustries, European Confederation of Pharmaceutical Entrepreneurs), 2 professional organisations (European Industrial Pharmacists Group, European Association of Hospital Pharmacists), 4 learned societies (European Society of Gene and Cell Therapy, European Society for Blood and Bone Marrow Transplantation, European Eye Bank Association, European Association of Tissue Banks, European Association of Hospital Pharmacists), 1 research institution taking the form of European project (European Network for the Advancement of Clinical Gene Transfer & Therapy), 1 European network based on national medicines agencies (EU innovation network). Then, in depth research has been conducted on the website of each organisation in order to identify their activity within and beyond gene and cell therapy regarding biomedical innovation in general. On the one hand, this poster highlights the main results concerning their organization: especially structure, governance, potential change of name or merger over time, as well as specific or general working committees. On the second hand, their fields of activity are described following an analysis based on a set of keywords. Whereas some keywords are heavily used by all organisations (gene therapy, cell therapy for example), others are more specific (orphan medicine) and others very rare (organoid).
Aurélie Mahalatchimy, « Human Genome Editing for Research & EU Law », CIVIS Blended Intensive Programme: science, ethics & governance of human genome editing, University of Tübingen Germany, le 29 juillet 2023
Aurélie Mahalatchimy, « The fragmented regulatory landscape of human genome editing », CIVIS Blended Intensive Programme: science, ethics & governance of human genome editing, University of Tübingen (Online) Germany, le 09 juillet 2023
Aurélie Mahalatchimy, « Update on contributions on EU law on medicines », EU Health Law Seminar “Evolving EU health law following the Covid-19 pandemic”, Maynooth Ireland, le 23 juin 2023
Aurélie Mahalatchimy, Adrien Bottacci, « Quel futur pour le cadre juridique des tissus et des organes destinés à la transplantation ? Le cas des organoïdes », Journée d'étude du projet ITEGOREC, Compiègne, le 14 juin 2023
Aurélie Mahalatchimy, « Challenges for the implementation of the current EU legal frameworks to organoids », Biotechnologies: towards collective wisdom: New forms of life: how should organoids be regulated?, En ligne, le 22 mai 2023
Aurélie Mahalatchimy, Auxane Delage, Luc-Sylvain Gilbert, Hsin-Yu Kuo, Jennifer Lorigan, « Illustrating regulatory requirements for the development of Gene and Cell therapy products with the EuroGCT research pathways », le 23 avril 2023
1.Background Communicating information on the regulatory framework applicable to gene and cell therapies, at every stage of development and towards every actor involved, is a challenge. Therapy development needs to comply with several regulatory requirements mostly to ensure products’ and patients’ safety, the complexity comes from the diversity of the regulatory frameworks. Some requirements are binding, others are guidance only. Most aspects are governed by European Union law, but some remain regulated on a national scale. The regulatory landscape is a combination of general and specific rules and guidance depending on competent institutions (e.g. EU and Member States regulatory agencies or health technology assessment bodies), types of products, and steps of their developments. 2.Methods The European Consortium for Communicating Gene and Cell Therapy Information (EuroGCT) is building an online tool to provide research pathways’ information. Therefore, communicating clear, precise, and accurate information in the form of a database. It will allow professionals of the field as well as patients to be informed on all regulatory aspects of the development of a Gene and Cell therapy product. 3.Results Depending on the legal classification of these therapies different regulatory pathways appear, which are shown on the EuroGCT website. Becoming a “one-stop shop” for accurate legal information on the legal classification of Gene and Cell therapies from lab to patient. 4.Conclusions The tool will facilitate better decision-making at key points in development of new therapies and thus enable improved product development, by providing the research community and regulatory and healthcare authorities with an information source on the practical steps needed for cell and gene therapy development.
Aurélie Mahalatchimy, « Les spécificités règlementaires des essais cliniques pour les médicaments innovants », Séminaire « Essais cliniques », Marseille, le 13 avril 2023
Les essais cliniques des médicaments innovants soulèvent des enjeux règlementaires particuliers au regard de l’équilibre juridique à trouver pour faciliter l’accès des patients à ces médicaments tout en garantissant leur sécurité. Au sein des médicaments innovants, seuls les médicaments de thérapie innovante constituent une catégorie juridique particulière pour lesquels il existe un régime juridique spécifique, principalement issu du droit de l’Union européenne. Par ailleurs, des mesures règlementaires ont été établies par l’Agence Nationale de Sécurité des Médicaments pour faciliter le développement et en particulier les essais cliniques portant sur les médicaments innovants en France. Cette communication présente à la fois les règles mises en place aux niveaux du droit de l’Union européenne et du droit français concernant les essais cliniques de médicaments, et en particulier de médicaments de thérapie innovante.
Aurélie Mahalatchimy, Eloïse Gennet, « Panel discussion on EU pharmaceutical activity: challenges arising from the pharmaceutical strategy and beyond », Panel discussion on EU pharmaceutical activity, Online United Kingdom, le 25 janvier 2023
Aurélie Mahalatchimy, « La natalité comme enjeu stratégique de politique de santé publique », La natalité comme enjeu stratégique de politique de santé publique, 10ème Colloque international France-Chine, 8ème rencontre franco-chinoise de la santé, Online, le 15 décembre 2022
Organisé par Xin Chen et Bénédicte Bevière-Boyer, sous l’égide du Centre sino-européen (CSE), de l’Université de médecine et des sciences de la santé de Shanghai, de l’Institut de recherche en santé (HIRI), de la Faculté de Overseas de l’Université Jiao Tong de Shanghai et du Centre de recherches juridiques en droit privé et en droit de la santé de l’Université Paris 8
Aurélie Mahalatchimy, Fabien Milanovic, « Les organoïdes en action : Les aspects éthiques dans ORGANACT, projet de recherche interdisciplinaire en sciences sociales sur les organoïdes », Les rencontres du GDR organoïdes, Paris, le 01 décembre 2022
Aurélie Mahalatchimy, « The pandemic Treaty from an EU law perspective », Roundtable on “Access, equity and the relevance of the Pandemic Treaty: lessons from the COVID-19 response”, 15th European Public Health Conference 2022, Berlin Germany, le 09 novembre 2022
Aurélie Mahalatchimy, Auxane Delage, Luc-Sylvain Gilbert, Hsin-Yu Kuo, Jennifer Lorigan, « The new European regulation on Health Technology Assessment: what changes for Advanced Therapy Medicinal Products ? », le 11 octobre 2022
In the European Union, gene and cell therapy medicinal products are mainly regulated by the specific legal framework applicable to Advanced Therapy Medicinal Products (ATMPs): regulation (EC) n°1394/2007. Yet most ATMPs that have been authorised for marketing in the European Union are also classified as orphan medicinal products. The latter are regulated by a different but also specific legal instrument : Regulation (EC) n°141/2000, which aims to promote the development of innovative medicines for orphan diseases thanks to a set of incentives for investigators. However, after twenty years of implementation, results are still unsatisfactory for several reasons. One of these reasons is that the market of orphan medicinal products had “started to look more similar to ‘standard’ medicines” than innovative medicines like ATMPs. Moreover, it has also been observed that even when marketed, orphan medicinal products fail in being equally accessible to patients in the different Member States. The European Commission has started a long and thorough revision process of the pharmaceutical legislation in order to give a new impulse to the development of, and access to, truly innovative orphan medicinal products, which may have a positive impact for patients as well as for investigators working on gene and cell therapies. In this poster, we will discuss what aspects of the revision of the regulation on orphan medicinal products may have an impact on the development of gene and cell therapy in the European Union.
Aurélie Mahalatchimy, Éloïse Gennet, « Presentation of the Joint Statement on “Health as a fundamental value. Towards an equitable and inclusive pharmaceutical strategy for the EU” », EU Health Policy Platform Annual Meeting, Brussels Belgium, le 05 mai 2022
Aurélie Mahalatchimy, Julie Veran, Michael Morrison, Florence Sabatier, Léa Chey, « Quality control and batch release aspects of Advanced Therapy Medicinal Products », le 21 avril 2022
Quality control and batch release raise specific challenges for ensuring quality and complying with regulatory requirements in order to obtain manufacturing and marketing authorizations for Advanced Therapy Medicinal Products (ATMPs). ATMPs are medicinal products based on genes, cells and tissues that have been specifically regulated in the European Union (EU) from 2007. In the guidelines on Good Manufacturing Practices (GMP) specific to ATMPs from the European Commission, specific requirements cover quality control and batch release. They are distinct from the ones than can be found in other guidelines on GMP applicable to other kinds of biological medicinal products. Through a comparative textual analysis of the GMP guidelines for biological medicinal products and ATMPs, this poster will highlight the key areas of similarities and differences. Our analysis mainly focuses on qualification and validation procedures, batch release process, quality defects and product recalls, and automated production of ATMPs. This analysis reveals why we have two different texts and whether they are based on substantial differences regarding quality control and batch release between ATMPs and other types of biological medicinal products.
Aurélie Mahalatchimy, Luc-Sylvain Gilbert, Edouard Habib, « Comparative quality aspects of gene therapy medicinal products and medicinal products containing genetically modified cells », Meeting of the EAHL Interest Group on Supranational Biolaw, Annual Conference of the European Association of Health Law, 20-22 April 2022, Ghent Belgium, le 20 avril 2022
The European Medicines Agency has recently revised its guidelines on quality, non-clinical and clinical aspects of Gene Therapy Medicinal Products (GTMPs text) and of medicinal products containing genetically modified cells (GMCMPs text), respectively in 2018 for the former and in 2020 for the latter. The latest revision has been particularly justified by the new developments in genome editing techniques, especially the wide use of the CRISPR-Cas technique, and with T-cells. Gene therapy medicinal product (GTMP) is a legal sub-category of medicines among Advanced Therapy Medicinal Products (ATMPs). However, medicinal product containing genetically modified cells (GMCMP) is not explicitly mentioned as a legal subcategory under EU regulation n°1394/2007 on ATMPs. Nevertheless, both GTMPs and GMCMPs should be considered as ATMPs under European Union Law. On the one hand, quality issues have been raised for all ATMPs regarding the reproducibility of the manufacturing process given the variable character of the starting materials. On the other hand, there is an overlap in the scope of the aforementioned guidelines when medicinal products containing genetically modified cells are to be considered gene therapy medicinal products. What are the similarities and differences between the quality of gene therapy medicinal products and the quality of medicinal products containing genetically modified cells while both are ATMPs? This poster is based on a comparative analysis of the quality sections of the two above-mentioned texts. In a first systematic approach, we identified the similarities and the specificities of texts outline (sub-section titles). Then, we analysed contents through the establishment of 3 types of comparative tables using color codes: common titles, different titles with similar contents, different titles with different contents in order to highlight similarities and specificities regarding the quality requirements between these two kinds of medicinal products when they are intended for use in humans and presented for marketing authorization applications.
Aurélie Mahalatchimy, Éloïse Gennet, Florence Sabatier, Julie Veran, Diack Adja Fatou, « What specificity for the clinical aspects of investigational advanced therapy medicinal products? », le 01 avril 2022
While Advanced Therapy Medicinal Products (ATMPs), a European legal classification of medicinal products based on genes, cells and tissues, raise specific quality issues, the latter are particularly acute in the context of clinical trials of ATMPs. In comparison to more traditional medicinal products, ATMPs have been subject to specific regulatory provisions in the European Union (EU) since 2007. In addition, many new guidelines have also been adopted to consider the issues raised by ATMPS. Most importantly for investigational ATMPs, the European Commission has adopted and published Guidelines on Good Clinical Practice specific to ATMPs in 2019. Not only are these guidelines targeting ATMPs, they also have a dedicated section on investigational ATMPs exploring the particular challenges raised when tissues and cells of human origin, are administered to a human trial subject, including when ATMPS incorporate medical devices, or delivered with the aim of reconstituting a given bodily tissue or organ. The aim of this poster is to highlight the specificity of quality requirements of investigational ATMPs by examining the dedicated subsections in the guidelines published by the European Commission and analysing them through the lens of the corresponding scientific literature. On the basis of the identification of the specific requirements regarding the quality of investigational ATMPs, the poster will reveal why they raise specific challenges and why these challenges deserve separate regulation in order to demonstrate quality in clinical trials.
Aurélie Mahalatchimy, Valentin Roby, « The institutional genealogy of the processes of fragmentation and defragmentation of the European law of biomedical innovations », I-Biolex, 2nd Project Meeting and 1st SAG Meeting, Aix-en -Provence, le 21 mars 2022
Aurélie Mahalatchimy, « Les cellules souches et la recherche dans la révision de la loi relative à la bioéthique », Colloque « Regards croisés sur la loi de bioéthique », Toulouse, le 14 octobre 2021
Organisé par l’Institut Maurice Hauriou de l’Université Toulouse Capitole, la Chaire UNESCO « Éthique Science et Société » et l’Espace de Réflexion Éthique
Aurélie Mahalatchimy, Eloïse Gennet, « Proposal on “Health as a fundamental value. Towards an equitable and inclusive pharmaceutical strategy for the EU” », [Annulé] Les enjeux actuels de l’expertise internationale dans les domaines de la santé et de l’environnement, Aix-en-Provence, le 07 juillet 2021
Organisé par le CERIC, à l’initiative de l’Association Internationale Droit Ethique et Science, avec le soutien de la Commission nationale française pour l’UNESCO et du Centre de Droit de la Santé (UMR7268 ADES)
Aurélie Mahalatchimy, Guylène Nicolas, Perron Martine, « Présentation du projet de recherche Transhumansime: de nouveaux droits Partie 2 », Conférence « Transhumansime: de nouveaux droits » Partie 2, Aix-en-Provence, le 27 mai 2021
Organisé par le CERIC (UMR DICE) et le CDSA (UMR ADES) sous le patronage de la Commission nationale française pour l'UNESCO et avec le soutien de l'Académie d'Aix-Marseille et de la MGEN
Aurélie Mahalatchimy, « Le transhumanisme à l'ère de la médecine améliorative », Le transhumanisme à l'ère de la médecine "améliorative", le 10 mai 2021
Organisé dans le cadre de la 7ème rencontre du droit et de la justice de l'Ambassade de France en Chine sous la responsabilité scientifique de A. Cayol, Wang Wei et B. Bévière-Boyer
Aurélie Mahalatchimy, Guylène Nicolas, Perron Martine, « OBSERVATIONS SUR LA COMMUNICATION, LES RELATIONS INTERPERSONNELLES ET LES INTERACTIONS DANS LES CLASSES AUTOUR DE LA THEMATIQUE TRANSHUMANISME ET DROIT », Conférence « Transhumansime :de nouveaux droits » Partie 1, Aix-en-Provence, le 25 mars 2021
Conférence en ligne organisée par Aurélie MAHALATCHIMY, Chargée de recherche CNRS, et Guylène NICOLAS, Maître de conférences à l’AMU, en coordination avec la Commission Nationale Française pour l’UNESCO.
Aurélie Mahalatchimy, Emmanuelle Rial-Sebbag, « Analyse des risques en santé : entre droit(s), sciences, éthique et attentes sociétales », e-colloque « Analyse des risques en santé : entre droit(s), sciences, éthique et attentes sociétales approches européenne et nationale », Journées Louis Dubouis, Toulouse, le 12 mars 2021
Journée Louis Dubouis organisée dans le cadre de la chaire DESAPS sous la direction scientifique de Nathalie de Grove-Valdeyron, Chaire Jean Monnet et Emmanuelle Rial-Sebbag, Chaire UNESCO, Ethique, Science et Société
Aurélie Mahalatchimy, « Participants’ introduction. General Project Update », I-Biolex, 1st Project Meeting, Aix-en-Provence, le 08 décembre 2021
Aurélie Mahalatchimy, Eloïse Gennet, « Health as a fundamental value. Towards an inclusive and equitable pharmaceutical strategy for the EU », Health in Europe, Virtual, le 20 octobre 2021
Aurélie Mahalatchimy, Eloïse Gennet, « Health as a fundamental value. Towards an equitable and inclusive pharmaceutical strategy for the EU », EU Health Policy Platform Kick-off meeting, 2021 Thematic Networks, Aix-en-Provence, le 24 septembre 2021
Aurélie Mahalatchimy, « La révision de la loi française relative à la bioéthique et les médicaments de thérapie innovante », Rencontre « Médicaments de thérapie innovante » Eurobiomed, Marseille, le 14 septembre 2021
Aurélie Mahalatchimy, Guylène Nicolas, « Les droits fondamentaux comme frontières de la médecine améliorative de l'humain », Colloque webinaire, "Le transhumanisme à l'ère de la médecine améliorative", Virtual, le 11 mai 2021
Aurélie Mahalatchimy, Éloïse Gennet, « Activities of the EAHL IG on Supranational Biolaw in 2021-2022: Public consultation & Thematic Network », Meeting of the EAHL Interest Group on Supranational Biolaw, 20 April 2022, Annual Conference of the European Association of Health Law, Ghent, Belgium, 20-22 April 2022., Ghent Belgium, le 22 avril 2021
Aurélie Mahalatchimy, Pin Lean, Phoebe Li, Mark Flear, « Framing and Legitimating EU Legal Regulation of Human Gene-Editing Technologies: Key Facets and Functions of an Imaginary », Virtual Symposium of the Journal of law and the Biosciences on “Law, Biomedical Technoscience and Imaginaries”, Virtual, le 04 février 2021
Aurélie Mahalatchimy, Mark Flear, « Bioconstitutionalism in the European Union regulation of gene-editing technologies », The Global Summit organized by The International Forum on the Future of Constitutionalism, Virtual, le 12 janvier 2021
Aurélie Mahalatchimy, Isabelle Moine-Dupuis, « Medicines as private goods for common use? An argumentation from medicines based on human biological elements », Workshop on “The market for medicines in the face of unsatisfied needs: emergency adaptations or a reform on a permanent legal basis?”, Dijon, le 10 novembre 2020
Aurélie Mahalatchimy, « L’édition du génome humain face au droit », Conférence de l’Université Pour Tous, Cahors, le 08 octobre 2020
Aurélie Mahalatchimy, « Law and ethics beyond gene editing », 46th Annual Meeting of the European Society for Blood and Marrow Transplantation (EBMT), Virtual, le 01 août 2020
Aurélie Mahalatchimy, « Innovation & Healthcare – New challenges for Europe », Innovation & Healthcare – New challenges for Europe, Toulouse, le 25 septembre 2019
7th EAHL Conference under the auspices of the Secretary General of the Council of Europe, Mr Thorbjorn Jagland
Aurélie Mahalatchimy, Alex Faulkner, Andrew Webster, « The delivery of advanced therapies to patients: challenges and solutions », EuroScience Open Forum, Toulouse, le 09 juillet 2018
Aurélie Mahalatchimy, « Medical devices vs medicinal products: what is the impact of the recent European regulatory changes? », Annual Meeting on Law & Society, Toronto Canada, le 07 juin 2018
Aurélie Mahalatchimy, « Médicaments de thérapie innovante et gestion des risques: quelle place pour le principe de précaution? », Journées Louis Dubouis, Les nouveaux enjeux de la politique pharmaceutique européenne: pour des produits de santé sûrs, innovants et accessibles, Toulouse, le 23 mai 2018
Aurélie Mahalatchimy, « How can we facilitate the delivery of advanced therapies to patients? », 44th ANNUAL MEETING of the European Society for Blood and Marrow Transplantation (EBMT2108), Lisbonne Portugal, le 18 mars 2018
Aurélie Mahalatchimy, Virginie Tournay, Anne-Marie Duguet, Emmanuelle Rial-Sebbag, « Transformer des cellules souches embryonnaires : quels enjeux éthiques et juridiques », 18th world Congress on Medical Law, Zagreb Croatia, le 08 août 2010
Aurélie Mahalatchimy, Virginie Tournay, Emmanuelle Rial-Sebbag, « Legal and ethical controversies around medical uses of stem cells: Is Medical Ethics Really in the Best interest of the Patient? », Extra Session on Stem Cells Ethics, Uppsala Sweden, le 14 juin 2010
Aurélie Mahalatchimy, Claire Misi, Marine Migliore, Antoine Chevallier, Guylène Nicolas, « Thérapie génique germinale et transhumanisme: entre amélioration de la qualité de vie et eugénisme »

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De la police municipale aux polices municipales : entre unité de statut et diversité de doctrines et de moyens

Mélanges en l'honneur de Michel Pédamon

Service-public.gouv.fr

L'interprétation des lois

Acteurs et normes de protection de l’environnement face à la crise écologique : bilan et perspectives

L’indemnisation des préjudices dans la sphère professionnelle

La pratique de la justice amiable

Le droit français de la concurrence déloyale entre passé et avenir

Le silence

Le renouvellement de la recherche en droit

Perspectives juridiques et interdisciplinaires sur la notion de vulnérabilité

L’action internationale des outre-mer

30 ans après, retour sur l'ouvrage de François Ost, « La Nature hors la loi. L'écologie à l'épreuve du droit »

Réflexions franco-chinoises sur le droit des nouvelles technologies en santé humaine

Le Devenir des morts

De la police municipale aux polices municipales : entre unité de statut et diversité de doctrines et de moyens

Mélanges en l'honneur de Michel Pédamon

Service-public.gouv.fr

L'interprétation des lois

Acteurs et normes de protection de l’environnement face à la crise écologique : bilan et perspectives

L’indemnisation des préjudices dans la sphère professionnelle

La pratique de la justice amiable

Le droit français de la concurrence déloyale entre passé et avenir

Le silence

Le renouvellement de la recherche en droit

Perspectives juridiques et interdisciplinaires sur la notion de vulnérabilité

L’action internationale des outre-mer

30 ans après, retour sur l'ouvrage de François Ost, « La Nature hors la loi. L'écologie à l'épreuve du droit »

Réflexions franco-chinoises sur le droit des nouvelles technologies en santé humaine

Le Devenir des morts

Aurélie Mahalatchimy

Actualités scientifiques

Publications scientifiques