{"id":15317,"date":"2026-03-13T10:35:15","date_gmt":"2026-03-13T09:35:15","guid":{"rendered":"https:\/\/scinnov.eu\/?p=15317"},"modified":"2026-03-13T10:35:17","modified_gmt":"2026-03-13T09:35:17","slug":"revision-of-the-lue-pharma-package-new-european-union-rules","status":"publish","type":"post","link":"https:\/\/scinnov.eu\/en\/revision-du-pharma-package-de-lue-nouvelles-regles-de-l-union-europeenne\/","title":{"rendered":"EU \"Pharma Package\" revision : new EU rules on medicines"},"content":{"rendered":"\n[et_pb_section fb_built=\u00a0\u00bb1&Prime; _builder_version=\u00a0\u00bb4.27.6&Prime; _module_preset=\u00a0\u00bbdefault\u00a0\u00bb global_colors_info=\u00a0\u00bb{}\u00a0\u00bb theme_builder_area=\u00a0\u00bbpost_content\u00a0\u00bb][et_pb_row _builder_version=\u00a0\u00bb4.27.6&Prime; _module_preset=\u00a0\u00bbdefault\u00a0\u00bb global_colors_info=\u00a0\u00bb{}\u00a0\u00bb theme_builder_area=\u00a0\u00bbpost_content\u00a0\u00bb][et_pb_column type=\u00a0\u00bb4_4&Prime; _builder_version=\u00a0\u00bb4.27.6&Prime; _module_preset=\u00a0\u00bbdefault\u00a0\u00bb global_colors_info=\u00a0\u00bb{}\u00a0\u00bb theme_builder_area=\u00a0\u00bbpost_content\u00a0\u00bb][et_pb_text _builder_version=\u00a0\u00bb4.27.6&Prime; _module_preset=\u00a0\u00bbdefault\u00a0\u00bb global_colors_info=\u00a0\u00bb{}\u00a0\u00bb theme_builder_area=\u00a0\u00bbpost_content\u00a0\u00bb]<h2 class=\"mb-3 text-base leading-relaxed\"><span class=\"font-semibold\">Qu\u2019est-ce que le \u00ab\u00a0Pharma package\u00a0\u00bb ?<\/span><\/h2>\n<p class=\"mb-3 text-base leading-relaxed\">Le \u00ab\u00a0Pharma package\u00a0\u00bb met \u00e0 jour la r\u00e9glementation actuelle sur les m\u00e9dicaments afin de mieux r\u00e9pondre aux besoins des patients et de soutenir la concurrence et l\u2019innovation.<\/p>\n<p class=\"mb-3 text-base leading-relaxed\">Il s\u2019agit de la premi\u00e8re r\u00e9vision majeure de la l\u00e9gislation pharmaceutique de l\u2019UE depuis 2004. Son objectif est de mieux r\u00e9pondre aux besoins des patients en :<\/p>\n<ul class=\"marker:text-action-primary-default mb-3 ml-4 list-inside list-disc space-y-1\">\n<li class=\"[&amp;&gt;p:first-child]:inline\"><strong>stimulant l\u2019innovation et la comp\u00e9titivit\u00e9<\/strong> gr\u00e2ce \u00e0 des incitations pour les nouveaux antimicrobiens, les m\u00e9dicaments contre les maladies rares et les traitements p\u00e9diatriques ;<\/li>\n<li class=\"[&amp;&gt;p:first-child]:inline\"><strong>rem\u00e9diant aux probl\u00e8mes de s\u00e9curit\u00e9 d\u2019approvisionnement et de p\u00e9nuries<\/strong> afin de garantir la disponibilit\u00e9 en temps voulu de m\u00e9dicaments s\u00fbrs et abordables dans toute l\u2019UE.<\/li>\n<\/ul>\n<p class=\"mb-3 text-base leading-relaxed\">Le 11 d\u00e9cembre 2025, le Conseil et le Parlement europ\u00e9en sont parvenus \u00e0 un <strong>accord provisoire sur le \u00ab pharma package \u00bb de l\u2019UE,<\/strong> concr\u00e9tisant ainsi la r\u00e9forme la plus approfondie de la l\u00e9gislation pharmaceutique europ\u00e9enne depuis plus de 20 ans.<\/p>[\/et_pb_text][et_pb_text _builder_version=\u00a0\u00bb4.27.6&Prime; _module_preset=\u00a0\u00bbdefault\u00a0\u00bb global_colors_info=\u00a0\u00bb{}\u00a0\u00bb theme_builder_area=\u00a0\u00bbpost_content\u00a0\u00bb]<h2 class=\"mb-3 text-base leading-relaxed\"><span class=\"font-semibold\">Quels sont les changements apport\u00e9s par le \u00ab\u00a0Pharma package\u00a0\u00bb ?<\/span><\/h2>\n<p class=\"mb-3 text-base leading-relaxed\">Les \u00e9l\u00e9ments cl\u00e9s comprennent :<\/p>\n<ul class=\"marker:text-action-primary-default mb-3 ml-4 list-inside list-disc space-y-1\">\n<li class=\"[&amp;&gt;p:first-child]:inline\"><strong>Huit ans de protection des donn\u00e9es et un an de protection du march\u00e9<\/strong> pour les nouveaux m\u00e9dicaments, avec une <strong>extension possible d\u2019un an<\/strong> pour les produits innovants.<\/li>\n<li class=\"[&amp;&gt;p:first-child]:inline\">Des mesures visant \u00e0 <strong>garantir la disponibilit\u00e9 des m\u00e9dicaments<\/strong> essentiels, permettant aux \u00c9tats membres d\u2019exiger un approvisionnement suffisant lorsque la protection r\u00e9glementaire s\u2019applique.<\/li>\n<li class=\"[&amp;&gt;p:first-child]:inline\">Une <strong>\u00ab exemption Bolar \u00bb<\/strong> renforc\u00e9e, permettant aux m\u00e9dicaments g\u00e9n\u00e9riques et biosimilaires d\u2019entrer sur le march\u00e9 imm\u00e9diatement apr\u00e8s l\u2019expiration du brevet.<\/li>\n<li class=\"[&amp;&gt;p:first-child]:inline\">Un <strong>nouveau bon d\u2019exclusivit\u00e9 transf\u00e9rable<\/strong> pour inciter au d\u00e9veloppement d\u2019antibiotiques prioritaires, assorti de garanties pour limiter les impacts sur les budgets nationaux de sant\u00e9.<\/li>\n<\/ul>\n<h2 class=\"mb-3 text-base leading-relaxed\"><span class=\"font-semibold\">Prochaines \u00e9tapes <\/span><\/h2>\n<p class=\"mb-3 text-base leading-relaxed\">L\u2019accord attend d\u00e9sormais l\u2019approbation formelle du Conseil et du Parlement europ\u00e9en avant d\u2019entrer en vigueur lors de sa publication au <strong>Journal officiel de l\u2019UE.<\/strong><\/p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=\u00a0\u00bb1_3,2_3&Prime; make_equal=\u00a0\u00bbon\u00a0\u00bb _builder_version=\u00a0\u00bb4.27.2&Prime; _module_preset=\u00a0\u00bbdefault\u00a0\u00bb background_color=\u00a0\u00bb#D6E5F3&Prime; custom_margin=\u00a0\u00bb50px||||false|false\u00a0\u00bb custom_padding=\u00a0\u00bb0px||0px||false|false\u00a0\u00bb border_radii=\u00a0\u00bbon|30px|30px|30px|30px\u00a0\u00bb global_colors_info=\u00a0\u00bb{}\u00a0\u00bb theme_builder_area=\u00a0\u00bbpost_content\u00a0\u00bb][et_pb_column type=\u00a0\u00bb1_3&Prime; _builder_version=\u00a0\u00bb4.27.2&Prime; _module_preset=\u00a0\u00bbdefault\u00a0\u00bb background_image=\u00a0\u00bbhttps:\/\/scinnov.eu\/wp-content\/uploads\/2024\/10\/Scinnov-forme-actom-Partenaire.svg\u00a0\u00bb background_size=\u00a0\u00bbcontain\u00a0\u00bb background_position=\u00a0\u00bbcenter_left\u00a0\u00bb global_colors_info=\u00a0\u00bb{}\u00a0\u00bb theme_builder_area=\u00a0\u00bbpost_content\u00a0\u00bb][et_pb_divider show_divider=\u00a0\u00bboff\u00a0\u00bb _builder_version=\u00a0\u00bb4.27.2&Prime; _module_preset=\u00a0\u00bbdefault\u00a0\u00bb global_colors_info=\u00a0\u00bb{}\u00a0\u00bb theme_builder_area=\u00a0\u00bbpost_content\u00a0\u00bb][\/et_pb_divider][\/et_pb_column][et_pb_column type=\u00a0\u00bb2_3&Prime; module_class=\u00a0\u00bbcentrer-verticalement\u00a0\u00bb _builder_version=\u00a0\u00bb4.27.2&Prime; _module_preset=\u00a0\u00bbdefault\u00a0\u00bb custom_padding=\u00a0\u00bb30px||30px||false|false\u00a0\u00bb global_colors_info=\u00a0\u00bb{}\u00a0\u00bb theme_builder_area=\u00a0\u00bbpost_content\u00a0\u00bb][et_pb_text _builder_version=\u00a0\u00bb4.27.6&Prime; _module_preset=\u00a0\u00bbdefault\u00a0\u00bb text_font=\u00a0\u00bbsilka-regular||||||||\u00a0\u00bb text_text_color=\u00a0\u00bb#181B30&Prime; text_line_height=\u00a0\u00bb1.5rem\u00a0\u00bb header_font_size=\u00a0\u00bb22px\u00a0\u00bb header_2_text_color=\u00a0\u00bb#181B30&Prime; header_2_font_size=\u00a0\u00bb35px\u00a0\u00bb header_2_line_height=\u00a0\u00bb2.75rem\u00a0\u00bb global_colors_info=\u00a0\u00bb{}\u00a0\u00bb theme_builder_area=\u00a0\u00bbpost_content\u00a0\u00bb]<h3>Pour plus d&rsquo;informations :<\/h3>\n<p><a href=\"https:\/\/health.ec.europa.eu\/document\/download\/ded6dd79-efd3-4abc-a683-48e68647833f_en?filename=mp_2025_pharma-reform_factsheet_en.pdf\" target=\"_blank\" rel=\"noopener\">Pharma-reform<\/a><\/p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section]\n","protected":false},"excerpt":{"rendered":"<p>Qu\u2019est-ce que le \u00ab\u00a0Pharma package\u00a0\u00bb ? Le \u00ab\u00a0Pharma package\u00a0\u00bb met \u00e0 jour la r\u00e9glementation actuelle sur les m\u00e9dicaments afin de mieux r\u00e9pondre aux besoins des patients et de soutenir la concurrence et l\u2019innovation. Il s\u2019agit de la premi\u00e8re r\u00e9vision majeure de la l\u00e9gislation pharmaceutique de l\u2019UE depuis 2004. Son objectif est de mieux r\u00e9pondre aux besoins des patients en : stimulant l\u2019innovation et la comp\u00e9titivit\u00e9 gr\u00e2ce \u00e0 des incitations pour les nouveaux antimicrobiens, les m\u00e9dicaments contre les maladies rares et les traitements p\u00e9diatriques ; rem\u00e9diant aux probl\u00e8mes de s\u00e9curit\u00e9 d\u2019approvisionnement et de p\u00e9nuries afin de garantir la disponibilit\u00e9 en temps voulu de m\u00e9dicaments s\u00fbrs et abordables dans toute l\u2019UE. Le 11 d\u00e9cembre 2025, le Conseil et le Parlement europ\u00e9en sont parvenus \u00e0 un accord provisoire sur le \u00ab pharma package \u00bb de l\u2019UE, concr\u00e9tisant ainsi la r\u00e9forme la plus approfondie de la l\u00e9gislation pharmaceutique europ\u00e9enne depuis plus de 20 ans.Quels sont les changements apport\u00e9s par le \u00ab\u00a0Pharma package\u00a0\u00bb ? Les \u00e9l\u00e9ments cl\u00e9s comprennent : Huit ans de protection des donn\u00e9es et un an de protection du march\u00e9 pour les nouveaux m\u00e9dicaments, avec une extension possible d\u2019un an pour les produits innovants. Des mesures visant \u00e0 garantir la disponibilit\u00e9 des m\u00e9dicaments [&hellip;]<\/p>\n","protected":false},"author":5,"featured_media":15330,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_et_pb_use_builder":"on","_et_pb_old_content":"","_et_gb_content_width":"","inline_featured_image":false,"footnotes":""},"categories":[4],"tags":[],"class_list":["post-15317","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-actualites"],"_links":{"self":[{"href":"https:\/\/scinnov.eu\/en\/wp-json\/wp\/v2\/posts\/15317","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/scinnov.eu\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/scinnov.eu\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/scinnov.eu\/en\/wp-json\/wp\/v2\/users\/5"}],"replies":[{"embeddable":true,"href":"https:\/\/scinnov.eu\/en\/wp-json\/wp\/v2\/comments?post=15317"}],"version-history":[{"count":7,"href":"https:\/\/scinnov.eu\/en\/wp-json\/wp\/v2\/posts\/15317\/revisions"}],"predecessor-version":[{"id":15332,"href":"https:\/\/scinnov.eu\/en\/wp-json\/wp\/v2\/posts\/15317\/revisions\/15332"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/scinnov.eu\/en\/wp-json\/wp\/v2\/media\/15330"}],"wp:attachment":[{"href":"https:\/\/scinnov.eu\/en\/wp-json\/wp\/v2\/media?parent=15317"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/scinnov.eu\/en\/wp-json\/wp\/v2\/categories?post=15317"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/scinnov.eu\/en\/wp-json\/wp\/v2\/tags?post=15317"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}