1,721,127 research outputs found
Transformation of human cells, legal support and health system organisation issues
No full textLes cellules humaines sont aujourd'hui utilisées suite à leur potentiel thérapeutique afin de traiter des maladies jusqu'alors incurables. Ceci peut engendrer des enjeux juridiques et éthiques car les cellules sont avant tout des éléments du corps humain qu'il convient de protéger. A ce titre, le régime des droits fondamentaux de protection de la personne leur est applicable. Cette utilisation d'éléments issus du corps humains ne vient pas remettre en cause l'approche fondée sur les droits fondamentaux mais nécessite de la percevoir autrement. Cette thèse présente alors les enjeux juridiques, éthiques et pour le système de santé de la possible transformation des cellules humaines en produit de santé. Sur le plan du droit, une première question tient au degré de transformation de ces cellules et à leur qualification et régime juridique, une fois transformées en produit de santé. Au niveau éthique ce travail s'interroge sur la place et l'effectivité de l'éthique de la recherche appliquée au domaine de la thérapie cellulaire. Enfin, sur le plan des pratiques et du système de santé, nous interrogeons la place des différents acteurs (acteurs publics, privés et patients) pour l'accompagnement et le développement de l'usage des cellules en thérapie de manière sécuritaire. Cette étude portera ainsi sur les conditions juridiques du développement de la thérapie cellulaire mais en dépassant ce cadre afin d'appréhender globalement la gouvernance actuelle de cette filière innovante. Cette gouvernance de la thérapie cellulaire s'avère complexe car la France n'a envisagé que récemment une politique globale de soutien pour la valorisation de l'utilisation des cellules en thérapie. Ainsi, le système de santé apparait fragile afin d'accueillir ces produits prometteurs ce qui soulève alors des enjeux en terme d'accès de ces thérapies pour les patients.Human cells are currently used because of their therapeutic potential to treat previously incurable diseases. This may raise legal and ethical issues, as cells are part of the human body which use is protected. Thus, fundamental rights for the protection of the individual is applicable to them. This use of elements derived from the human body does not question the fundamental rights-based approach but requires a different perception of it. This thesis, then, presents the legal, ethical and health system implications of the possible transformation of human cells into health products. From a legal point of view, the degree of transformation of these cells and their qualification and legal status once transformed into a health product constitute a first issue. At the ethical level, this work questions the place and effectiveness of research ethics applied to the field of cell therapy. Finally, on the level of health practices and of the health system, we question the role of the different actors (public, private actors and patients) for supporting and developing the safe use of cells in therapy. This study will, therefore, focus on the legal conditions for the development of cell therapy, but is conducted beyond this framework in order to gain an overall understanding of the current governance of this innovative sector. This cell therapy governance is complex because France has only recently envisaged a global support policy for the valorisation of the use of cells in therapy. Thus, the health system appears insecure in order to pave the way for these promising products, as a consequence this raises issues in terms of patients' access to these therapies
Umbilical Cord Blood Banking, Research and Clinical Applications. Report and recommendations
No full textstatus: Published onlin
Deciphering the fragmentation of the human genome editing regulatory landscape
No full textInternational audienceGenome 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
La valeur des données et informations génétiques pour la santé: une mosaïque juridique
No full textInternational audienc
Information génétique et lois de bioéthique.
No full textDossier les nouvelles frontières de la Loi de bioéthiqueInternational audienc
The human body and the body elements—Conditions for their use in genetics under the French bioethics law and beyond
No full textInternational audienceFrench legislation has strictly regulated genetic analysis since the adoption of the bioethics laws in 1994. Following a historical perspective, we discuss how French laws have provided a stable legal regime for access to and use of the human body and its elements until the recent revision of the laws. We present the main bioethical principles attached to the human body and their jurisprudential treatment. We balance this approach of stability by showing the strong evolution of the provisions regulating genetics in French laws. Initially based on and centred on the protection of the individual, we present and analyse the new possibilities for using genetic analysis in the name of solidarity with family members and with society as a whole, for research perspectives and for public health prevention
Limiter le marché des thérapies cellulaires non éprouvées : réalité ou utopie ?
No full textInternational audienceStem cell therapies raise strong regulatory issues because there are advanced treatments based on human elements. They lead to therapeutic hopes but also unknown risks. Stem cell-based therapies are currently being studied and only a few are on the market. Nevertheless, in recent years, their use in therapy has increased for therapeutic purposes and they have been widely deployed worldwide but without these treatments having been validated by a competent authority. Regarding the health consequences that these practices can induce, it becomes urgent to limit them.Les thérapies cellulaires constituent un véritable enjeu réglementaire car ce sont des traitements innovants d’origine humaine. Elles suscitent de nombreux espoirs thérapeutiques mais peuvent aussi engendrer des risques méconnus. Les médicaments à base de cellules souches sont actuellement en cours de développement et peu sont commercialisés. Néanmoins, depuis quelques années, la proposition de certaines cliniques de les utiliser à visée thérapeutique s’est largement déployée dans le monde pour traiter des maux de nature diverse mais sans que ces traitements aient été validés par une autorité compétente. Suite aux conséquences sanitaires que ces pratiques peuvent engendrer, il devient urgent de pouvoir les limiter
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