{"id":15317,"date":"2026-03-13T10:35:15","date_gmt":"2026-03-13T09:35:15","guid":{"rendered":"https:\/\/scinnov.eu\/?p=15317"},"modified":"2026-07-27T11:14:24","modified_gmt":"2026-07-27T09:14:24","slug":"revision-of-the-lue-pharma-package-new-european-union-rules","status":"publish","type":"post","link":"https:\/\/scinnov.eu\/en\/revision-of-the-lue-pharma-package-new-european-union-rules\/","title":{"rendered":"EU &#8220;Pharma Package&#8221; revision : new EU rules on medicines"},"content":{"rendered":"<p>[et_pb_section fb_built=&#8221;1&#8243; _builder_version=&#8221;4.27.6&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221; theme_builder_area=&#8221;post_content&#8221;][et_pb_row _builder_version=&#8221;4.27.6&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221; theme_builder_area=&#8221;post_content&#8221;][et_pb_column type=&#8221;4_4&#8243; _builder_version=&#8221;4.27.6&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221; theme_builder_area=&#8221;post_content&#8221;][et_pb_text _builder_version=&#8221;4.27.7&#8243; _module_preset=&#8221;default&#8221; hover_enabled=&#8221;0&#8243; global_colors_info=&#8221;{}&#8221; theme_builder_area=&#8221;post_content&#8221; sticky_enabled=&#8221;0&#8243;]<\/p>\n<h2 class=\"mb-3 text-base leading-relaxed\"><span class=\"font-semibold\">What is the pharma package?<\/span><\/h2>\n<p class=\"mb-3 text-base leading-relaxed\">The pharma package updates the current rules on medicines to better meet patient needs and support competition and innovation<\/p>\n<p class=\"mb-3 text-base leading-relaxed\">The pharma package is the first major revision of EU pharmaceutical laws since 2004. Its aim is to better meet patient needs by:<\/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>boosting innovation and competitiveness<\/strong><span>\u00a0<\/span>through incentives for new antimicrobials, rare disease medicines and treatments for children<\/li>\n<li class=\"[&amp;&gt;p:first-child]:inline\"><strong>addressing security of supply and shortages<\/strong><span>\u00a0<\/span>to ensure the timely availability of safe and affordable medicines across the EU.<\/li>\n<\/ul>\n<p class=\"mb-3 text-base leading-relaxed\">On 11 December 2025, the Council and the European Parliament reached a<span>\u00a0<\/span><strong>provisional agreement on the EU&#8217;s pharma package,<\/strong><span>\u00a0<\/span>delivering the most far-reaching reform of EU pharmaceutical legislation in over 20 years.<\/p>\n<p>[\/et_pb_text][et_pb_text _builder_version=&#8221;4.27.7&#8243; _module_preset=&#8221;default&#8221; hover_enabled=&#8221;0&#8243; global_colors_info=&#8221;{}&#8221; theme_builder_area=&#8221;post_content&#8221; sticky_enabled=&#8221;0&#8243;]<\/p>\n<h2 class=\"mb-3 text-base leading-relaxed\"><span class=\"font-semibold\">What changes under the pharma package?<\/span><\/h2>\n<p class=\"mb-3 text-base leading-relaxed\">Key elements include:<\/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>Eight years of data protection and one year of market protection<\/strong><span>\u00a0<\/span>for new medicines, with a<span>\u00a0<\/span><strong>one-year extension possible<\/strong><span>\u00a0<\/span>for innovative products.<\/li>\n<li class=\"[&amp;&gt;p:first-child]:inline\">Measures to<span>\u00a0<\/span><strong>ensure the availability of essential medicines<\/strong><span>\u00a0<\/span>, allowing Member States to require sufficient supply where regulatory protection applies.<\/li>\n<li class=\"[&amp;&gt;p:first-child]:inline\">A strengthened<span>\u00a0<\/span><strong>\u00abBolar exemption\u00bb<\/strong><span>\u00a0<\/span>enabling generic and biosimilar medicines to enter the market immediately after patent expiry.<\/li>\n<li class=\"[&amp;&gt;p:first-child]:inline\">A<span>\u00a0<\/span><strong>new transferable exclusivity voucher<\/strong><span>\u00a0<\/span>to incentivise the development of priority antibiotics, with safeguards to limit impacts on national healthcare budgets.<\/li>\n<\/ul>\n<h2 class=\"mb-3 text-base leading-relaxed\"><span class=\"font-semibold\">Next steps<\/span><\/h2>\n<p class=\"mb-3 text-base leading-relaxed\">The agreement now awaits formal approval by the Council and the European Parliament before entering into force upon publication in the<span>\u00a0<\/span><strong>Official Journal of the EU.<\/strong><\/p>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=&#8221;1_3,2_3&#8243; make_equal=&#8221;on&#8221; _builder_version=&#8221;4.27.2&#8243; _module_preset=&#8221;default&#8221; background_color=&#8221;#D6E5F3&#8243; custom_margin=&#8221;50px||||false|false&#8221; custom_padding=&#8221;0px||0px||false|false&#8221; border_radii=&#8221;on|30px|30px|30px|30px&#8221; global_colors_info=&#8221;{}&#8221; theme_builder_area=&#8221;post_content&#8221;][et_pb_column type=&#8221;1_3&#8243; _builder_version=&#8221;4.27.2&#8243; _module_preset=&#8221;default&#8221; background_image=&#8221;https:\/\/scinnov.eu\/wp-content\/uploads\/2024\/10\/Scinnov-forme-actom-Partenaire.svg&#8221; background_size=&#8221;contain&#8221; background_position=&#8221;center_left&#8221; global_colors_info=&#8221;{}&#8221; theme_builder_area=&#8221;post_content&#8221;][et_pb_divider show_divider=&#8221;off&#8221; _builder_version=&#8221;4.27.2&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221; theme_builder_area=&#8221;post_content&#8221;][\/et_pb_divider][\/et_pb_column][et_pb_column type=&#8221;2_3&#8243; module_class=&#8221;centrer-verticalement&#8221; _builder_version=&#8221;4.27.2&#8243; _module_preset=&#8221;default&#8221; custom_padding=&#8221;30px||30px||false|false&#8221; global_colors_info=&#8221;{}&#8221; theme_builder_area=&#8221;post_content&#8221;][et_pb_text _builder_version=&#8221;4.27.7&#8243; _module_preset=&#8221;default&#8221; text_font=&#8221;silka-regular||||||||&#8221; text_text_color=&#8221;#181B30&#8243; text_line_height=&#8221;1.5rem&#8221; header_font_size=&#8221;22px&#8221; header_2_text_color=&#8221;#181B30&#8243; header_2_font_size=&#8221;35px&#8221; header_2_line_height=&#8221;2.75rem&#8221; hover_enabled=&#8221;0&#8243; global_colors_info=&#8221;{}&#8221; theme_builder_area=&#8221;post_content&#8221; sticky_enabled=&#8221;0&#8243;]<\/p>\n<h3>For further information:<\/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>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section]<\/p>\n","protected":false},"excerpt":{"rendered":"<p>What is the pharma package? The pharma package updates the current rules on medicines to better meet patient needs and support competition and innovation The pharma package is the first major revision of EU pharmaceutical laws since 2004. Its aim is to better meet patient needs by: boosting innovation and competitiveness\u00a0through incentives for new antimicrobials, rare disease medicines and treatments for children addressing security of supply and shortages\u00a0to ensure the timely availability of safe and affordable medicines across the EU. On 11 December 2025, the Council and the European Parliament reached a\u00a0provisional agreement on the EU&#8217;s pharma package,\u00a0delivering the most far-reaching reform of EU pharmaceutical legislation in over 20 years.What changes under the pharma package? Key elements include: Eight years of data protection and one year of market protection\u00a0for new medicines, with a\u00a0one-year extension possible\u00a0for innovative products. Measures to\u00a0ensure the availability of essential medicines\u00a0, allowing Member States to require sufficient supply where regulatory protection applies. A strengthened\u00a0\u00abBolar exemption\u00bb\u00a0enabling generic and biosimilar medicines to enter the market immediately after patent expiry. A\u00a0new transferable exclusivity voucher\u00a0to incentivise the development of priority antibiotics, with safeguards to limit impacts on national healthcare budgets. Next steps The agreement now awaits formal approval by the Council [&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-news"],"_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":0,"href":"https:\/\/scinnov.eu\/en\/wp-json\/wp\/v2\/posts\/15317\/revisions"}],"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}]}}