{"id":11780,"date":"2013-04-18T12:19:53","date_gmt":"2013-04-18T11:19:53","guid":{"rendered":"https:\/\/faus-moliner.com\/ca\/las-estrategias-ante-la-aprobacion-genericos-las-normas-defensa-la-competencia\/"},"modified":"2016-04-18T15:41:28","modified_gmt":"2016-04-18T14:41:28","slug":"las-estrategias-ante-la-aprobacion-genericos-las-normas-defensa-la-competencia","status":"publish","type":"post","link":"https:\/\/faus-moliner.com\/ca\/las-estrategias-ante-la-aprobacion-genericos-las-normas-defensa-la-competencia\/","title":{"rendered":"Las estrategias ante la aprobaci\u00f3n de gen\u00e9ricos y las normas de defensa de la competencia"},"content":{"rendered":"<p><strong>Antecedentes<\/strong><\/p>\n<p>Los medicamentos gen\u00e9ricos a base de clopido\u001fgrel\u00a0 que se apro\u001fbaron a partir de Julio de 2008, cuando expira\u001fron las patentes de base de este producto, presentaban dos dife\u001frencias respecto de Plavix\u00ae que era el medicamento de referencia: los gen\u00e9ricos conten\u00edan una sal de clopidro\u001fgel distinta de la utilizada para Pla\u001fvix\u00ae; y no po\u001fd\u00edan incluir, entre sus indicaciones aprobadas, el tratamiento del s\u00edndrome corona\u001frio agudo en combinaci\u00f3n con \u00e1cido acetil salic\u00ed\u001flico.<\/p>\n<p>Estas di\u001fferencias se deb\u00edan a que tanto la sal de clopi\u001fdogrel usada en Plavix\u00ae como la indica\u001fci\u00f3n en cuesti\u00f3n segu\u00edan protegidas por paten\u001ftes es\u001fpe\u001fc\u00edficas hasta febrero 2013 y febrero 2017 respectivamente.<\/p>\n<p>Es sabido que la normativa europea dispone que las diferentes sales de una sustancia activa se considerar\u00e1n la misma sustancia activa, a me\u001fnos que tengan propiedades considerablemente diferentes en cuanto a seguridad y\/o eficacia; y que se permite tambi\u00e9n la autorizaci\u00f3n de gen\u00e9\u001fricos con exclusi\u00f3n de indicaciones del medica\u001fmento original que a\u00fan est\u00e9n protegidas por pa\u001ftentes.<\/p>\n<p>En esta situaci\u00f3n, la cuesti\u00f3n sobre la que se pronuncia la Autoridad de la Competencia fran\u001fcesa versa sobre la informaci\u00f3n que la compa\u00f1\u00eda titular del f\u00e1rmaco de referencia puede en su caso facilitar a los profesionales sanitarios, ante el lanzamiento del gen\u00e9rico.<\/p>\n<p><strong>Informaci\u00f3n versus abuso<\/strong><\/p>\n<p>En este ca\u001fso que nos ocupa, la Autoridad fran\u001fcesa consider\u00f3 que Sanofi-Aventis hab\u00eda dise\u00f1a\u001fdo y puesto en pr\u00e1ctica una estrate\u001fgia de comu\u001fnicaci\u00f3n espec\u00edficamente diri\u001fgida a sembrar con\u001ffusi\u00f3n acerca de las propie\u001fdades de los gen\u00e9ri\u001fcos; y que gracias a ello con\u001fsigui\u00f3 que la pene\u001ftraci\u00f3n de los mismos en el mercado fuera muy inferior a lo habitual.<\/p>\n<p>Sin entrar a valorar la decisi\u00f3n, lo cual no proce\u001fde en este comentario, debemos destacar dos aspectos. En primer lugar, advertir sobre la v\u00eda procesal escogida por la compa\u00f1\u00eda gen\u00e9rica que present\u00f3 la denuncia. Denunciar una campa\u00f1a de informaci\u00f3n o de promoci\u00f3n en base a la normativa de defensa de la competencia es po\u001fsible, y puede que sea m\u00e1s atractivo que hacerlo ante los tribunales ordinarios o ante los sistemas de autorregulaci\u00f3n. La decisi\u00f3n de la Autoridad francesa es un ante\u001fcedente a tener muy presen\u001fte.<\/p>\n<p>En segundo lu\u001fgar, las normas que proh\u00edben los abusos de posi\u001fci\u00f3n de dominio o las conductas desleales de\u001fben tenerse siempre muy presentes a la hora de considerar las estrategias a adoptar ante cam\u001fbios en la estructura del mercado. De\u001ffender la posici\u00f3n que se ha logrado gracias a la innovaci\u00f3n y a los esfuer\u001fzos propios es leg\u00edtimo, pero la frontera con el abu\u001fso y la deslealtad puede ser muy tenue; y la lec\u001ftura de esta Decisi\u00f3n demuestra que algu\u001fnas administraciones est\u00e1n dispuestas a sacar mu\u001fcha punta al l\u00e1piz.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Antecedentes Los medicamentos gen\u00e9ricos a base de clopido\u001fgrel\u00a0 que se apro\u001fbaron a partir de Julio de 2008, cuando expira\u001fron las patentes de base de este producto, presentaban dos dife\u001frencias respecto de Plavix\u00ae que era el medicamento de referencia: los gen\u00e9ricos conten\u00edan una sal de clopidro\u001fgel distinta de la utilizada para Pla\u001fvix\u00ae; y no po\u001fd\u00edan incluir,&#8230; <\/p>\n<div class=\"clear\"><\/div>\n<p><a href=\"https:\/\/faus-moliner.com\/ca\/las-estrategias-ante-la-aprobacion-genericos-las-normas-defensa-la-competencia\/\" class=\"excerpt-read-more\">M\u00e9s informaci\u00f3<\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"categories":[272,286,331,393,395],"tags":[],"coauthors":[],"class_list":["post-11780","post","type-post","status-publish","format-standard","hentry","category-capsulas-ca","category-dret-farmaceutic-i-life-sciences","category-dret-farmaceutic-i-life-sciences-ca","category-generics-ca","category-generics-ca-2"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.6 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Las estrategias ante la aprobaci\u00f3n de gen\u00e9ricos y las normas de defensa de la competencia - Faus Moliner<\/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:\/\/faus-moliner.com\/ca\/las-estrategias-ante-la-aprobacion-genericos-las-normas-defensa-la-competencia\/\" \/>\n<meta property=\"og:locale\" content=\"ca_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Las estrategias ante la aprobaci\u00f3n de gen\u00e9ricos y las normas de defensa de la competencia - Faus Moliner\" \/>\n<meta property=\"og:description\" content=\"Antecedentes Los medicamentos gen\u00e9ricos a base de clopido\u001fgrel\u00a0 que se apro\u001fbaron a partir de Julio de 2008, cuando expira\u001fron las patentes de base de este producto, presentaban dos dife\u001frencias respecto de Plavix\u00ae que era el medicamento de referencia: los gen\u00e9ricos conten\u00edan una sal de clopidro\u001fgel distinta de la utilizada para Pla\u001fvix\u00ae; y no po\u001fd\u00edan incluir,... 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