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International audience

International audience

International audience

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 de4 ans (2021-2024) vise à étudier les processus de fragmentation et de défragmentation du droit européen applicableaux 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 ceprojet 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, auxconditions 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 valorisationdes résultats.

International audience

International audience

International audience

International audience

International audience

Although several European law instruments specifically promote the development of orphan medicines, rare disease patients still suffer from an excessive lack of access to orphan drugs. In order to base a claim for equity of access to research benefits, health vulnerability is introduced as a human rights-based public health concept. It represents a potentially valuable and powerful means in European law for rare disease patients to claim for an improved public action to develop innovative orphan drugs, including through the use of novel data-driven technologies such as computer modelling and simulation, as they have the potential to palliate some of the obstacles in the current development process of orphan medicines. The human rights-based approach would be all the more valuable, as it would simultaneously draw attention on privacy aspects of vulnerability for orphan disease patients, especially regarding increased risks stemming from the processing of highly sensitive health data.

International audience

International audience; At the cost of an actual definition, vulnerability is mainly approached by the designation of vulnerablecategories whose characteristics are questionable because contradictory. The trauma of the abusiveexperiments from the past has triggered a – initially well intentioned – categorical exclusion ofvulnerable people from clinical trials which also lead to their exclusion from the benefits of researchprogresses in health care. In order to clarify this contradiction, largely allowed by the relativecharacter of the concept of vulnerability, it is suggested to distinguish between different types of risks(for autonomy and for health) and different perspectives (individual and collective). The analysis willbe conducted through the lens of the decisional vulnerability of the trial participant on the one hand,and through the lens of the health vulnerability of the future vulnerable patient on the other hand.; Au détriment d’une véritable définition, la vulnérabilité est majoritairement appréhendée par la désignation de catégories vulnérables dont les caractéristiques soulèvent interrogations et contradictions. Le traumatisme des expérimentations abusives de l’histoire a conduit à une exclusion quasi systématique des groupes vulnérables des essais, dans un but bienveillant mais avec comme conséquence une exclusion des bénéfices des progrès de la recherche en santé. Afin de clarifier ces contradictions, permises par le caractère nécessairement relatif du concept de vulnérabilité, cette thèse propose de distinguer différents types de risques (pour l’autonomie d’une part, pour la santé d’autre part) et différentes perspectives (individuelle et collective), conduisant à la mise en valeur de deux prismes d’analyse : la vulnérabilité décisionnelle du participant vulnérable et la vulnérabilité de santé du patient vulnérable.

As the main medications consumers, elderly persons are estimated to represent up to 30% of the European population in 2050. Paradoxically there is a considerable lack of information about drug prescription in older persons, which is compromising the quality of treatments, and leaving to physicians the considerable responsibility of improvised prescriptions, which are potentially either dangerous or ineffective. In fact, the geriatric population is either excluded from clinical trials or represented by relatively healthy elderly persons who do not accurately represent real world patients. Despite repeated demonstrations of the need to include frail elderly persons in clinical trials in the medical literature, European law only offers disappointing responses to the problem. The frequent decline in older persons' cognitive capacities makes the task even more difficult (cognitive frailty, early dementia like Alzheimer's disease or psychiatric disorders). Many older persons have reduced decision making capacity without benefiting from legal protection yet. Surprisingly, ethics guidelines as well as European law are not very sensitive to the phases before legal incompetence, and do not consider alternative ways to obtain informed consent as suggested in medical and ethical literature. Although these questions fall under national competencies, the issue is common to Europe and solutions will necessarily have to go beyond state borders. Involving the European legislator is essential in order to at least act as an incentive for a better inclusion of frail elderly persons in biomedical research, and for a better promotion of their autonomy.

Regulating paediatric research means searching for the balance between two valuable goals: protecting children while ensuring they benefit from safe and efficient medicines. Different legal instruments were adopted in the eu in order to regulate clinical trials, foster paediatric research and promote European and international ethical guidelines. However a new Regulation on clinical trials was adopted in 2014, and might change the current framework of paediatric research. How does the new Regulation 536/2014 foster research on children taking into account both the eu Paediatric Regulation and the eu Ethical Recommendations? Does it live up to the standards of the Directive 2001/20/ec and does it represent a step forward in accordance with international ethical guidelines? This article shows that, despite the adoption of new rules, many clarifications are still needed. Stakeholders involved in paediatric research have to play a driving role in the implementation process of the new Regulation.

International audience

International audience

Principales consommatrices de medicaments, les personnes âgees sont estimees representer 30 % de la population europeenne d’ici 2050. Paradoxalement, il existe un cruel manque d’information sur la prescription des medicaments a la population geriatrique compromettant la qualite des traitements et laissant aux medecins l’immense responsabilite de prescriptions improvisees potentiellement dangereuses ou au contraire potentiellement inefficaces. En effet, la population geriatrique est de facto soit exclue des essais cliniques, soit representee par des personnes âgees en relativement bonne sante et peu representatives des patients de la vie reelle. Malgre les demonstrations repetees dans la doctrine medicale du besoin d’inclusion de personnes âgees fragiles dans les essais cliniques, le droit europeen n’offre que des reponses decevantes a ce besoin. Le declin frequent des facultes cognitives des personnes âgees rend la tâche doublement difficile (fragilite cognitive, debut de demence comme l’Alzheimer ou maladies psychiatriques). Beaucoup de personnes âgees presentent une capacite de decision reduite sans encore beneficier de protection juridique. Etonnamment, les lignes directrices ethiques ainsi que le droit europeen sont peu sensibles aux stades qui precedent l’incapacite juridique et ne font pas suite aux procedes intermediaires proposes dans la doctrine ethique et medicale. Bien que ces questions relevent des competences nationales, la problematique est commune a l’Europe et les solutions devront necessairement depasser les frontieres etatiques. L’implication du legislateur europeen est indispensable pour, si ce n’est imposer des regles communes, au moins donner une impulsion dans le sens d’une meilleure inclusion des personnes âgees fragiles dans les recherches biomedicales, et d’une meilleure promotion de leur autonomie.

International audience

International audience

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.