{"id":4146,"date":"2022-03-09T09:59:10","date_gmt":"2022-03-09T08:59:10","guid":{"rendered":"https:\/\/www.universalmedica.com\/?p=4146"},"modified":"2026-01-05T17:24:25","modified_gmt":"2026-01-05T16:24:25","slug":"comment-obtenir-la-designation-de-medicament-orphelin-dans-lunion-europeenne","status":"publish","type":"post","link":"https:\/\/www.universalmedica.com\/fr\/comment-obtenir-la-designation-de-medicament-orphelin-dans-lunion-europeenne\/","title":{"rendered":"Comment obtenir la d\u00e9signation de m\u00e9dicament orphelin dans l\u2019Union Europ\u00e9enne&nbsp;?"},"content":{"rendered":"<p>Il existe plus de 7000 maladies rares, affectant plus de 400 millions de personnes dans le monde et 30 millions de personnes dans l\u2019Union Europ\u00e9enne. Cependant, seulement 5% environ des maladies rares ont actuellement un traitement autoris\u00e9. Comme beaucoup de ces maladies mettent la vie en danger, il existe un s\u00e9rieux besoin de d\u00e9velopper de nouveaux m\u00e9dicaments pour les maladies rares.<\/p>\n<p>Historiquement, le d\u00e9veloppement de m\u00e9dicaments pour les maladies rares a souvent \u00e9t\u00e9 limit\u00e9 par un certain nombre d\u00e9fis, avec notamment un faible retour sur investissement au regard des exigences r\u00e9glementaires importantes, du faible taux de r\u00e9ussite, de la faible pr\u00e9valence des maladies, du manque de compr\u00e9hension des maladies, etc.<\/p>\n<p>La reconnaissance de cet enjeu par les autorit\u00e9s comp\u00e9tentes a conduit \u00e0 la cr\u00e9ation de politiques et d\u2019incitations en mati\u00e8re d\u2019autorisation, de fixation de prix et de remboursement afin d\u2019encourager et stimuler la recherche et le d\u00e9veloppement de m\u00e9dicaments orphelins (m\u00e9dicaments pour les maladies rares). En UE, le Committee for Orphan Medicinal Product (COMP) est le comit\u00e9 de l\u2019European Medicines Agency (EMA) charg\u00e9 d\u2019examiner et d\u2019\u00e9valuer les demandes de d\u00e9signation de m\u00e9dicaments orphelins. Sur la base de l\u2019avis du COMP, la Commission Europ\u00e9enne d\u00e9cide de garantir ou non une d\u00e9signation de m\u00e9dicament orphelin pour les m\u00e9dicaments.<\/p>\n<p>Afin d\u2019obtenir une d\u00e9signation de m\u00e9dicament orphelin, le m\u00e9dicament doit r\u00e9pondre aux crit\u00e8res suivants\u00a0:<\/p>\n<ul>\n<li>Le m\u00e9dicament doit \u00eatre destin\u00e9 au diagnostic, traitement ou \u00e0 la pr\u00e9vention d\u2019une affection mettant la vie en danger ou entrainant une invalidit\u00e9 chronique,<\/li>\n<li>La pr\u00e9valence de la maladie ne doit pas \u00eatre sup\u00e9rieure \u00e0 5 sur 10\u00a0000 dans l\u2019Union Europ\u00e9enne ou il doit \u00eatre peu probable que la commercialisation du m\u00e9dicament g\u00e9n\u00e8re des revenus suffisants pour justifier l\u2019investissement n\u00e9cessaire \u00e0 son d\u00e9veloppement,<\/li>\n<li>Aucune m\u00e9thode satisfaisante de diagnostic, pr\u00e9vention ou traitement de l\u2019affection concern\u00e9e ne peut \u00eatre autoris\u00e9e ou, si une telle m\u00e9thode existe, le m\u00e9dicament doit apporter un b\u00e9n\u00e9fice significatif aux personnes atteintes par la maladie.<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p>Une fois que le m\u00e9dicament a re\u00e7u la d\u00e9signation de m\u00e9dicament orphelin par la Commission Europ\u00e9enne, il est inscrit au registre communautaire des m\u00e9dicaments orphelins et le promoteur peut b\u00e9n\u00e9ficier d\u2019un certain nombre de mesures incitatives.<\/p>\n<p>Le r\u00e8glement (EC) No. 141\/2000 d\u00e9crit la proc\u00e9dure et les incitations au d\u00e9veloppement et \u00e0 la commercialisation de m\u00e9dicaments d\u00e9sign\u00e9s orphelins dans l\u2019Union Europ\u00e9enne.<\/p>\n<p><strong>Les incitations propos\u00e9es pour les m\u00e9dicaments orphelins dans l\u2019union europ\u00e9enne incluent\u00a0: <\/strong><\/p>\n<ul>\n<li>une assistance pour le protocole \u00e0 des tarifs r\u00e9duits (d\u00e9pendant du statut du promoteur),<\/li>\n<li>une r\u00e9duction des frais de demande de l\u2019autorisation de mise sur le march\u00e9, d\u2019inspection avant l\u2019autorisation, de modification de l\u2019autorisation de mise sur le march\u00e9 et des redevances annuels,<\/li>\n<li>l\u2019acc\u00e8s \u00e0 la proc\u00e9dure centralis\u00e9e, un processus unique d\u2019autorisation de mise sur le march\u00e9. Pour en savoir plus sur ce processus unique d\u2019autorisation de mise sur le march\u00e9 de l\u2019EMA, veuillez consulter <a href=\"https:\/\/www.universalmedica.com\/en\/how-to-obtain-the-emas-single-marketing-authorization\/\">How to obtain the EMA\u2019s Single Marketing Authorization?<\/a>,<\/li>\n<li>dix ans d\u2019exclusivit\u00e9 commerciale \/ de protection du m\u00e9dicament orphelin autoris\u00e9, dans une indication particuli\u00e8re. D\u2019autres mesures d\u2019incitations sont propos\u00e9es pour les micros, petites et moyennes entreprises (PME). Pour en savoir plus, veuillez consulter <a href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory-overview\/research-development\/orphan-designation-research-development\/orphan-incentives\">Orphan Incentives<\/a>.<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p>Les politiques et incitations offertes par la Commission Europ\u00e9enne pour le d\u00e9veloppement et la commercialisation de m\u00e9dicaments d\u00e9sign\u00e9s orphelins ont permis aux entreprises pharmaceutiques de recourir \u00e0 de nouvelles technologies et \u00e0 une compr\u00e9hension pour le d\u00e9veloppement de th\u00e9rapies r\u00e9volutionnaires ces derni\u00e8res ann\u00e9es.<\/p>\n<p>Sources :<\/p>\n<p><a href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/overview\/orphan-designation-overview\">https:\/\/www.ema.europa.eu\/en\/human-regulatory\/overview\/orphan-designation-overview<\/a><\/p>\n<p><a href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory-overview\/research-development\/orphan-designation-research-development\/applying-orphan-designation\">https:\/\/www.ema.europa.eu\/en\/human-regulatory-overview\/research-development\/orphan-designation-research-development\/applying-orphan-designation<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Il existe plus de 7000 maladies rares, affectant plus de 400 millions de personnes dans le monde et 30 millions de personnes dans l\u2019Union Europ\u00e9enne. Cependant, seulement 5% environ des maladies rares ont actuellement un traitement autoris\u00e9. Comme beaucoup de ces maladies mettent la vie en danger, il existe un s\u00e9rieux besoin de d\u00e9velopper de [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":4147,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"categories":[135,134,144],"tags":[],"class_list":["post-4146","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-compliance-2","category-pharmacovigilance","category-redaction-medicale"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.6 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Comment obtenir la d\u00e9signation de m\u00e9dicament orphelin dans l\u2019Union Europ\u00e9enne&nbsp;? - Universal Medica<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.universalmedica.com\/fr\/comment-obtenir-la-designation-de-medicament-orphelin-dans-lunion-europeenne\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Comment obtenir la d\u00e9signation de m\u00e9dicament orphelin dans l\u2019Union Europ\u00e9enne&nbsp;? - Universal Medica\" \/>\n<meta property=\"og:description\" content=\"Il existe plus de 7000 maladies rares, affectant plus de 400 millions de personnes dans le monde et 30 millions de personnes dans l\u2019Union Europ\u00e9enne. 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