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Le Médicament À Base De Plantes En Europe : Statut, Enregistrement, Contrôles Hélène Lehmann

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Le Médicament À Base De Plantes En Europe : Statut, Enregistrement, Contrôles Hélène Lehmann Le médicament à base de plantes en Europe : statut, enregistrement, contrôles Hélène Lehmann To cite this version: Hélène Lehmann. Le médicament à base de plantes en Europe : statut, enregistrement, contrôles. Droit. Université de Strasbourg, 2013. Français. NNT : 2013STRAJ024. tel-00936734 HAL Id: tel-00936734 https://tel.archives-ouvertes.fr/tel-00936734 Submitted on 27 Jan 2014 HAL is a multi-disciplinary open access L’archive ouverte pluridisciplinaire HAL, est archive for the deposit and dissemination of sci- destinée au dépôt et à la diffusion de documents entific research documents, whether they are pub- scientifiques de niveau recherche, publiés ou non, lished or not. The documents may come from émanant des établissements d’enseignement et de teaching and research institutions in France or recherche français ou étrangers, des laboratoires abroad, or from public or private research centers. publics ou privés. Université de Strasbourg – Faculté de Pharmacie Laboratoire de Biophotonique et Pharmacologie – UMR 7213 Centre d’Études Internationales et Européennes (CEIE) – EA 3396 THÈSE Présentée en vue de l’obtention du grade de Docteur de l’Université de Strasbourg École doctorale : « Sciences de la Vie et de la Santé » Discipline : « Sciences Pharmaceutiques » Spécialité : « Droit Pharmaceutique » par Hélène LEHMANN – docteur en pharmacie, titulaire d’un master ès Sciences Pharmaceutiques LE MÉDICAMENT À BASE DE PLANTES EN EUROPE. STATUT, ENREGISTREMENT, CONTRÔLES Soutenue le vendredi 5 avril 2013 devant un jury composé de Monsieur le Professeur Jean-Yves PABST, codirecteur de thèse Madame le Professeur Christiane HEITZ, codirecteur de thèse Monsieur le Professeur Serge POTIER, rapporteur interne Madame le Professeur Marie-Aleth LACAILLE-DUBOIS, rapporteur externe Madame le Professeur Florence TABOULET, rapporteur externe Madame le Docteur Nelly SÉGUR-FANTINO, examinateur externe Volume 1 1 Remerciements - Monsieur le Professeur Jean-Yves PABST, professeur de droit et d’économie de la santé, doyen de la Faculté de pharmacie et Vice-président « finances » de l’Université de Strasbourg, qui a accepté de codiriger cette thèse d’université, m’a guidée tout le long de son élaboration, de la formulation du sujet à la préparation de la soutenance, a effectué de multiples relectures patientes de mes écrits et m’a mis à disposition un certain nombre d’ouvrages de droit pharmaceutique. - Madame le Professeur Christiane HEITZ, professeur de pharmacologie à la Faculté de pharmacie de l’Université de Strasbourg, qui a accepté d’assurer la codirection de cette thèse, en binôme avec Monsieur le Professeur Jean-Yves PABST. - Monsieur le Professeur Serge POTIER, professeur de génétique, ancien doyen de la Faculté des Sciences de la Vie de l’Université de Strasbourg et actuel directeur de l’École Doctorale des Sciences de la Vie et de la Santé, qui a accepté de faire partie de ce jury. - Madame le Professeur Marie-Aleth LACAILLE-DUBOIS, professeur de pharmacognosie à l’Université de Bourgogne / Dijon et passionnée de phytothérapie, qui me fait l’honneur d’accepter de faire partie de ce jury en tant que rapporteur externe. - Madame le Professeur Florence TABOULET, professeur de droit et d’économie de la santé à l’Université Paul-Sabatier / Toulouse III, qui me fait l’honneur d’accepter de faire partie de ce jury en tant que rapporteur externe. - Monsieur le Docteur Bernard WENIGER, maître de conférences HDR à la Faculté de pharmacie de l’Université de Strasbourg (Laboratoire de Pharmacognosie et Molécules Naturelles Bioactives) qui m’a aidée dans ma prise de contact avec la Société française d’Ethnopharmacologie, me permettant ainsi de publier deux articles dans la revue Ethnopharmacologia. - Monsieur le Professeur Christian BONAH, professeur d’Histoire de la médecine à l’Université de Strasbourg, directeur du Département d’Histoire des Sciences de la Vie et de la Santé (DHVS) et membre de l’Institut Universitaire de France, qui m’a confié la charge d’assurer quelques heures de cours afférents à l’UE « L’innovation thérapeutique en perspective historique : sciences, technologie et société », dans le cadre du master « Sciences du médicament » de la Faculté de pharmacie de l’Université de Strasbourg. - Madame le Docteur Yveline RIVAL, directeur de ma thèse d’exercice et Directeur-adjoint de la Faculté de pharmacie de l’Université de Strasbourg, ainsi que Madame le Professeur Line BOUREL-BONNET qui m’ont vivement encouragée – à l’issue de la soutenance de ce premier mémoire – à poursuivre mes activités de recherche par une formation doctorale particulièrement enrichissante. - Monsieur le doyen Marc PHILONENKO, membre de l’Institut (Académie des inscriptions et belles-lettres), qui m’a conseillé la lecture de l’ouvrage fondamental du Docteur François DAGOGNET, La raison et les remèdes. 2 - Monsieur le Docteur Marc FOLLMER, Madame le Docteur Nelly SÉGUR-FANTINO – membre de ce jury en tant qu’examinateur – Madame le Docteur Elisabeth MARTIN- SUBIGER ainsi que l’ensemble des membres du service « Enregistrement et Développement Analytique » du laboratoire WELEDA S.A. de Huningue qui m’ont permis, à travers mon stage de fin d’études pharmaceutiques effectué en 2009, de m’initier à l’élaboration de dossiers d’enregistrement de spécialités pharmaceutiques et de monographies analytiques de souches homéopathiques. - Monsieur Ferdinand de HERDT, ancien secrétaire et actuel président de l’European Cooperation on Homeopathic and Anthroposophic Medicinal Product (ECHAMP), trésorier de l’Association des Entreprises Fabriquant des Médicaments Utilisés en Thérapeutique Anthroposophique (AEFMUTA) et membre de la direction du groupe WELEDA, qui m’a reçue à Bâle et m’a éclairée sur les avantages et inconvénients de la réglementation européenne des médicaments traditionnels à base de plantes, ainsi que sur les perspectives d’évolutions législatives à venir. - Monsieur le Docteur Christian BUSSER, ancien pharmacien à Obernai, Docteur en ethnologie et fondateur de l’école Plantasanté, qui m’a offert la possibilité de prononcer un cours sur « La médecine anthroposophique, entre science et spiritualité » lors de son séminaire consacré à « Ethnomédecine et sacré » à la Faculté d’Ethnologie de l’Université de Strasbourg. - Monsieur le Docteur Antoine AMARI qui m’a fait bénéficier de son expéreince d’ancien doctorant de M. PABST et de jeune enseignant en législation pharmaceutique à l’Université d’Abidjan (Côte d’Ivoire) et m’a fourni toutes les informations relatives à l’élaboration de la législation africaine des médicaments traditionnels à base de plantes. - Monsieur Léonard MALER, dont j’ai encadré le stage de fin d’études de master 2 de « Droit des Produits de Santé en Europe » au sein de l’équipe du Professeur PABST et qui m’a aidé dans mes recherches documentaires sur la situation réglementaire en matière de médicaments traditionnels à base de plantes en Europe ainsi que sur les aspects socio-économiques afférents aux médicaments à base de plantes. - Mademoiselle Emilie WEINLING, dont j’ai encadré le stage en laboratoire de 5e année d’études pharmaceutiques, qui a contribué au travail de veille réglementaire et de recherches bibliographiques concernant notamment la proposition de loi sur les herboristes, l’approche des Etats-Unis en matière de suppléments diététiques et de médicaments de phytothérapie et la question de la propriété intellectuelle, ainsi qu’à la mise à jour des tableaux annexes recensant les spécialités de phytothérapie en libre accès dans les officines françaises. - Mademoiselle Justine GRESLAND, dont j’ai également encadré le stage en laboratoire de 5e année d’études pharmaceutiques et qui a rédigé un mémoire intitulé « Préparation magistrale et préparation officinale. Législation française, suisse et allemande » et contribué à la traduction du Dictionnaire des termes techniques relatifs aux dispositifs médicaux. - Monsieur Amaury HAAG, dont j’ai encadré le stage en laboratoire de 5e année d’études pharmaceutiques, qui a rédigé un mémoire intitulé « Les scandales sanitaires à l’origine d’évolutions législatives en France » et m’a aidée dans mes recherches du nouveau logo de l’ANSM. 3 - Monsieur Damien ETTWILLER, dont j’encadre actuellement le stage en laboratoire de 5e année d’études pharmaceutiques, qui prépare son mémoire de diplôme d’État de docteur en pharmacie sur « Les incitations administratives et financières visant à faciliter le placement et le maintien des médicaments sur le marché européen » et a par ailleurs effectué une relecture patiente de cette thèse. - Madame le Docteur Dominique BERNHARD-LOUVET, pharmacien titulaire de la Pharmacie de la Victoire à Mulhouse, qui a contribué à me former au métier de pharmacien d’officine – me permettant ainsi, parallèlement à ce travail universitaire, de garder un contact avec le monde officinal et d’observer ainsi les utilisations thérapeutiques de certains remèdes phytothérapiques mentionnés dans ce travail de recherche – et m’a mis à disposition, entre autres ouvarges, le Précis de botanique de P. CRÉTÉ. 4 LE MÉDICAMENT À BASE DE PLANTES EN EUROPE. STATUT, ENREGISTREMENT, CONTRÔLES Sommaire Introduction............................................................................................................................ 16 La situation mondiale en matière de médicaments à base de plantes ................................. 21 Première partie. Statut législatif du médicament à base de plantes et mise en place de sa réglementation en Europe ....................................................................................................
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