{"id":32363,"date":"2026-11-06T10:56:20","date_gmt":"2026-11-06T10:56:20","guid":{"rendered":"https:\/\/www.sib.it\/?p=32363"},"modified":"2026-11-06T10:57:31","modified_gmt":"2026-11-06T10:57:31","slug":"leu-pharma-package-cambia-gli-equilibri-tra-innovatori-e-genericisti","status":"publish","type":"post","link":"https:\/\/www.sib.it\/en\/articoli\/leu-pharma-package-cambia-gli-equilibri-tra-innovatori-e-genericisti\/","title":{"rendered":"L&#8217;EU Pharma package cambia gli equilibri tra innovatori e genericisti &#8211; P. Di Giovine, R. Beretta"},"content":{"rendered":"<p>La riforma della normativa farmaceutica europea, nota come \u201cEU Pharma Package\u201d, sar\u00e0 definitivamente approvata entro fine 2026.<img decoding=\"async\" class=\"size-full wp-image-27879 alignright lazyload\" data-src=\"https:\/\/www.sib.it\/wp-content\/uploads\/2024\/10\/Phmarma450.png\" alt=\"Pharmaceuticals UPC Milan\" width=\"450\" height=\"675\" data-srcset=\"https:\/\/www.sib.it\/wp-content\/uploads\/2024\/10\/Phmarma450.png 450w, https:\/\/www.sib.it\/wp-content\/uploads\/2024\/10\/Phmarma450-200x300.png 200w, https:\/\/www.sib.it\/wp-content\/uploads\/2024\/10\/Phmarma450-100x150.png 100w\" data-sizes=\"(max-width: 450px) 100vw, 450px\" src=\"data:image\/svg+xml;base64,PHN2ZyB3aWR0aD0iMSIgaGVpZ2h0PSIxIiB4bWxucz0iaHR0cDovL3d3dy53My5vcmcvMjAwMC9zdmciPjwvc3ZnPg==\" style=\"--smush-placeholder-width: 450px; --smush-placeholder-aspect-ratio: 450\/675;\" \/><\/p>\n<p>Una delle modifiche di maggior rilievo riguarda la cosiddetta \u201cBolar clause\u201d, la cui portata sar\u00e0 esplicitamente estesa anche alle procedure di determinazione di prezzo e rimborso nonch\u00e9, a determinate condizioni, alla partecipazione a bandi di gara pubblici.<\/p>\n<p><a href=\"https:\/\/www.sib.it\/il-nostro-team\/paolo-di-giovine-consulente-brevetti-chimica\/\" target=\"_blank\" rel=\"noopener\"><span class=\"fa4gm6 fa4l42\"><span class=\"fa4l42\" data-sdui-anchor-id=\"commentary-0NsiMu7Lb5o8Z7iM2O3-D5wE5KqReG7q11vccNWA6PA-b1ba5761-baca-4e70-a3fe-cdc90c9d516e::394\">Paolo Di Giovine<\/span><\/span><\/a> e <a href=\"https:\/\/www.sib.it\/il-nostro-team\/ruggero-giacomo-beretta\/\" target=\"_blank\" rel=\"noopener\"><span class=\"fa4gm6 fa4l42\"><span class=\"fa4l42\" data-sdui-anchor-id=\"commentary-0NsiMu7Lb5o8Z7iM2O3-D5wE5KqReG7q11vccNWA6PA-b1ba5761-baca-4e70-a3fe-cdc90c9d516e::413\">Ruggero Beretta<\/span><\/span><\/a> del nostro Team Life Sciences and Chemistry sono gli autori di un puntuale e sintetico articolo che illustra come la nuova \u201cBolar clause\u201d potrebbe cambiare le regole per l\u2019ingresso sul mercato di prodotti generici e biosimilari e la giurisprudenza sulla contraffazione in questo ambito, sottolineando sia le criticit\u00e0 che le opportunit\u00e0 che ci\u00f2 comporter\u00e0, dal punto di vista dei diritti di brevetto, per i produttori di generici da un lato, e per gli innovatori dall\u2019altro.<\/p>\n<p>Pi\u00f9 in generale, l\u2019entrata in vigore dell&#8217;EU Pharma Package porta con s\u00e9 la necessit\u00e0 di ripensare alcune strategie commerciali del settore farmaceutico, nel quale gli asset di propriet\u00e0 intellettuale assumeranno un peso sempre maggiore.<\/p>\n<p>&#x1f453; <a href=\"https:\/\/www.aboutpharma.com\/business-e-mercato\/il-pharma-package-europeo-cambia-gli-equilibri-tra-innovatori-e-genericisti\/\" target=\"_blank\" rel=\"noopener\">Leggi l&#8217;articolo pubblicato sulla rivista AboutPharma di novembre 2026<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>La riforma della normativa farmaceutica europea, nota come \u201cEU Pharma Package\u201d, sar\u00e0 definitivamente approvata entro fine 2026. Una delle modifiche di maggior rilievo riguarda la cosiddetta \u201cBolar clause\u201d, la cui portata sar\u00e0 esplicitamente estesa anche alle procedure di determinazione di prezzo e rimborso nonch\u00e9, a determinate condizioni, alla partecipazione a bandi di gara pubblici. Paolo [&hellip;]<\/p>\n","protected":false},"author":4,"featured_media":27879,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_exactmetrics_skip_tracking":false,"_exactmetrics_sitenote_active":false,"_exactmetrics_sitenote_note":"","_exactmetrics_sitenote_category":0,"footnotes":""},"categories":[14],"tags":[],"class_list":["post-32363","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-articoli"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.9 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>L&#039;EU Pharma package cambia gli equilibri tra innovatori e genericisti<\/title>\n<meta name=\"description\" content=\"L&#039;EU Pharma package cambia gli equilibri tra innovatori e genericisti, leggi l&#039;articolo di Paolo Di Giovine e Ruggero Beretta.\" \/>\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.sib.it\/en\/articoli\/leu-pharma-package-cambia-gli-equilibri-tra-innovatori-e-genericisti\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"L&#039;EU Pharma package cambia gli equilibri tra innovatori e genericisti\" \/>\n<meta property=\"og:description\" content=\"L&#039;EU Pharma package cambia gli equilibri tra innovatori e genericisti, leggi l&#039;articolo di Paolo Di Giovine e Ruggero Beretta.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.sib.it\/en\/articoli\/leu-pharma-package-cambia-gli-equilibri-tra-innovatori-e-genericisti\/\" \/>\n<meta property=\"article:published_time\" content=\"2026-11-06T10:56:20+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2026-11-06T10:57:31+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.sib.it\/wp-content\/uploads\/2024\/10\/Phmarma450.png\" \/>\n\t<meta property=\"og:image:width\" content=\"450\" \/>\n\t<meta property=\"og:image:height\" content=\"675\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Laura Ercoli\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Laura Ercoli\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.sib.it\\\/en\\\/articoli\\\/leu-pharma-package-cambia-gli-equilibri-tra-innovatori-e-genericisti\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.sib.it\\\/en\\\/articoli\\\/leu-pharma-package-cambia-gli-equilibri-tra-innovatori-e-genericisti\\\/\"},\"author\":{\"name\":\"Laura Ercoli\",\"@id\":\"https:\\\/\\\/www.sib.it\\\/en\\\/#\\\/schema\\\/person\\\/1255dc6724ea1afebed55937799ceb58\"},\"headline\":\"L&#8217;EU Pharma package cambia gli equilibri tra innovatori e genericisti &#8211; P. 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