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Jean-Philippe BESSE THESE DE DOCTORAT Présentée devant l’Université de METZ – UFR SCI.F.A. Pour l’obtention du Diplôme de Doctorat Spécialité Toxicologie de l’Environnement par Jean-Philippe BESSE Impact environnemental des médicaments à usage humain sur le milieu récepteur : évaluation de l’exposition et des effets biologiques pour les écosystèmes d’eau douce Soutenue le 02 mars 2010 Composition du Jury Mme. Paule VASSEUR , Professeur, Université de Metz ............................... ............ Directrice de thèse Mme. Jeanne GARRIC , Directrice de recherche, Cemagref Lyon ...........................Codirectrice de thèse Mme. Nathalie CHEVRE , Chargée de recherche, Université de Lausanne ... ........ Rapporteur M. Jean-Marie HAGUENOER , Professeur émérite, Université de Lille ..................Rapporteur M. Jean-Pierre CRAVEDI , Directeur de recherche, INRA Toulouse .... .. ................... Examinateur M. Jérôme GUITTON , Professeur, Université de Lyon ................. ... ......... ... .............. Examinateur M. Thomas PELTE , Agence de l’Eau Rhône-Méditerranée & Corse ........ ... ......... Membre invité THESE DE DOCTORAT Présentée devant l’Université de METZ – UFR SCI.F.A. Pour l’obtention du Diplôme de Doctorat Spécialité Toxicologie de l’Environnement par Jean-Philippe BESSE Impact environnemental des médicaments à usage humain sur le milieu récepteur : évaluation de l’exposition et des effets biologiques pour les écosystèmes d’eau douce Soutenue le 2 mars 2010 Composition du Jury Mme. Paule VASSEUR , Professeur, Université de Metz ............................... ............ Directrice de thèse Mme. Jeanne GARRIC , Directrice de recherche, Cemagref Lyon ...........................Codirectrice de thèse Mme. Nathalie CHEVRE , Chargée de recherche, Université de Lausanne ... .... .... Rapporteur M. Jean-Marie HAGUENOER , Professeur émérite, Université de Lille .................. Rapporteur M. Jean-Pierre CRAVEDI , Directeur de recherche, INRA Toulouse .... .. ........... ........ Examinateur M. Jérôme GUITTON , Professeur, Université de Lyon ................. ... ......... ... .............. Examinateur M. Thomas PELTE , Agence de l’Eau Rhône-Méditerranée & Corse ........ ... ......... Membre invité 3 4 Résumé Un nombre important de molécules pharmaceutiques sont consommées en France et peuvent contaminer le compartiment aquatique (eaux de surface, eaux souterraines, eaux potables) ; ce qui a conduit les gestionnaires et le public à s’interroger sur la présence et l’impact de ces substances dans l’environnement. Cette interrogation s’inscrit dans un contexte plus général de préservation de l’environnement et des ressources en eau. Ainsi au niveau Français, le second Plan National Santé Environnement (PNSE2) intègre désormais une action spécifique pour les médicaments visant à « améliorer la connaissance et réduire les risques liés aux rejets de médicaments dans l’environnement, en engageant dès le mois de juillet 2009 les travaux en vue de l’élaboration d’un plan d’action national … ». Compte du nombre important de molécules consommées en France, il est nécessaire, avant d’établir un protocole de surveillance des milieux, d’établir une liste de molécules prioritaires à surveiller. Le travail présenté ici s’est donc attaché à proposer une liste pertinente de molécules à rechercher dans les eaux de surface, en tenant compte des concentrations attendues dans l’environnement et des effets biologiques sur les organismes aquatiques. L’approche présentée ici s’est focalisée sur la contamination des eaux de surface via la consommation des médicaments par la population Française. Les autres sources ponctuelles de contamination, comme les usines de fabrication ou de conditionnement n’ont pas été évaluées. Par ailleurs, le travail de priorisation a été effectué pour les médicaments à usage humain et ne concerne pas les médicaments vétérinaires. Plusieurs méthodologies ont été mises en place, en fonction des substances médicamenteuses évaluées, mais également en fonction de la disponibilité des données. Au final, 300 molécules parentes couvrant majorité des classes thérapeutiques et chimiques utilisées, ainsi qu’une cinquantaine de métabolites humains ont été évalués et des listes de molécules prioritaires justifiables du point de vue scientifique et de l’état actuel des connaissances ont pu être définies. De plus, d’une manière plus générale, ce travail a permis de dégager les conclusions suivantes : Du point de vue de la toxicologie environnementale : • il est nécessaire d’augmenter le jeu de données écotoxicologiques ; • le risque principal associé aux rejets médicamenteux est un risque sur le long terme ; • il est important de considérer la question de la contamination par les substances médicamenteuses sous l’angle des mélanges et de leurs effets associés à la présence des autres types de contaminants. Du point de vue de la chimie environnementale : • pour les médicaments à usage humain, les stations d’épuration urbaine restent le point d’entrée privilégié dans le milieu récepteur ; • les usines de fabrication et/ou de conditionnement peuvent représenter des sources localisées de contamination ; • les données concernant la rémanence et la dégradation des médicaments dans l’environnement sont limitées et un effort doit être réalisé sur ce point ; • un effort doit également être porté sur la compréhension du comportement des médicaments dans l’environnement : sorption sur les matières en suspension, au sédiment et accumulation dans les organismes ; • l’utilisation de données modélisées, notamment sur la présence et les niveaux de contamination dans l’environnement est une alternative intéressante et complémentaire aux mesures chimiques systématiques. 5 Du point de vue de la gestion du risque : • il est nécessaire de limiter autant que possible la dissémination environnementale des médicaments, cette limitation pouvant passer par les mesures suivantes : o le développement d’une réglementation pour les produits de santé intégrant les considérations environnementales, o l’amélioration de l’information au niveau des professionnels de santé et des patients ; o une consommation raisonnée des produits de santé ; o l’amélioration des procédés de collecte et de traitement des eaux usées ; o le développement de la « chimie verte » au niveau industriel et le prise en compte des considérations environnementales dans l’élaboration de nouvelles molécules ; • la bonne gestion de cette problématique passera par l’entente entre les différentes agences publiques et services responsables de la santé publique (AFSSAPS, AFSSA, hôpitaux), de l’environnement (AFSSET, Agences de l’Eau, DRIRE…) et par l’implication des industriels et des professionnels de santé en général (médecins et pharmaciens). 6 Remerciements A Paule VASSEUR , à qui je dois un certain nombre de choses, entre autres mon premier travail en évaluation de risque et l’occasion de soutenir une thèse. A Jeanne GARRIC , pour m’avoir accueilli dans son laboratoire. Aux membres du jury , pour avoir accepté de juger ce travail, et pour s’être finalement mis d’accord sur une date de soutenance. A Anne CASTOT , Paul HOUETO , Alice ROULEAU , Dominique MASSET et Philippe CAVALIE de l’AFSSAPS, pour leur précieuse collaboration, sans laquelle ce travail ne serait probablement pas allé très loin ; avec des remerciements spéciaux pour Paul HOUETO, pour l’intérêt qu’il a porté à ce travail. Au Professeur François LOCHER , Doyen de la Faculté de Pharmacie de Lyon, pour m’avoir ouvert les portes du Centre de Documentation de la Pharmacie Centrale (CDIP). A Monique BOUCQUIN et à tous les membres du CDIP. A Jean-François LATOUR et Laurence GILLES , du Centre Léon Bérard, pour leur collaboration. A tous mes anciens collègues du Cemagref , car chacun d’entre eux a (consciemment ou non) contribué à faire mûrir et à améliorer ce travail. A Olivier GEFFARD , parce que mine de rien, mon travail doit beaucoup à sa remarque d’il y a deux ans sur les flavonoïdes, A Benoît Ferrari , pour avoir pris le temps de jeter un œil au manuscrit. A Marc Bray , pour m’avoir donné un coup de main sur mes fichiers Excel. A Marc Babut , pour avoir accepté les diverses prolongations sur mon premier CDD. A ma famille , qui désespère de me voir trouver un emploi durable et bien payé. A Hélène , pour me soutenir depuis 10 ans (ah, elle me dit que le mot exact est « supporter »).. A tous ceux enfin, qui doivent veiller sur moi là-haut, merci. A l’échéance de mes allocations chômages , qui en ce début d’année 2006 m’a contraint à chercher activement du travail, et à envoyer à tout hasard une candidature spontanée au Cemagref de Lyon… comme quoi… Au Professeur Raphaël « j’ai arrêté de boire » MONS , parce qu’il a réellement arrêté de boire 1. A Olivier « 171 points, tu nous dois tous une bière » ADAM , futur chômeur, comme moi, parce qu’il m’a fait découvrir « Chez Papa ». A Marion GUST , pour son amitié, l’intégrale des westerns de Clint Eastwood et parce que c’est une future chef d’UR. A ma voisine de palier Christelle LOPES , parce qu’elle est bien bien grave. 7 A Benoît XUEREB , que tôt ou tard je contraindrai à me rendre mes 5 euros, tout ça à cause de sa stagiaire. A Vincent FELTEN , que je suis allé voir chaque fois que je m’ennuyais dans mon travail, c’est-à-dire tous les jours et plusieurs fois par jours. A Renaud TUTUNDJIAN , grand amateur de jeux et de boisson, qui malgré tout ça arrive à ne faire que 70 points au test. A Arnaud CHAUMOT , mon ancien colloc, qui m’a fait comprendre que le terme « invertébré », tant usité en écotoxicologie,
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