{"id":11179,"date":"2023-11-24T00:57:00","date_gmt":"2023-11-23T16:57:00","guid":{"rendered":"https:\/\/flcube.com\/?p=11179"},"modified":"2024-11-04T00:59:02","modified_gmt":"2024-11-03T16:59:02","slug":"european-commission-proposes-overhaul-of-pharmaceutical-legislation","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=11179","title":{"rendered":"European Commission Proposes Overhaul of Pharmaceutical Legislation"},"content":{"rendered":"\n

The European Commission (EC) is advancing an update to Europe’s 20-year-old pharmaceutical legislation, with the dual goals of enhancing drug accessibility and bolstering research and development (R&D). The proposed changes have faced opposition from pharmaceutical associations, which argue that the new package shifts from fixed regulatory protection periods to a more flexible incentive-based system, prompting some companies to consider leaving the European market.<\/p>\n\n\n\n

Details of the Proposed Legislation<\/strong><\/p>\n\n\n\n

Announced in April, the proposal reduces the current data protection and market protection period from 8 years plus 2 years to 6 plus 2 years. This reduction is offset by potential extensions: an additional 2 years for products launched across all European Union (EU) countries, 6 months for drugs addressing unmet medical needs, and 6 months if comparative trial data is provided.<\/p>\n\n\n\n

For orphan drugs, the EC suggests a minimum market protection period of 9 years, with an additional year for pan-EU launches, another year for addressing high unmet medical needs, and up to 2 more years if new indications are developed post-approval.<\/p>\n\n\n\n

Commission’s Defense and Industry’s Concerns<\/strong><\/p>\n\n\n\n

The Commission justifies the new scheme as a means to foster innovation and address the disparity in access to innovative medicines, which are currently available primarily in wealthier EU nations. However, the pharmaceutical industry contends that drug accessibility is influenced by local healthcare systems and insurers, and warns that the new legislation could lead to a reduction in R&D investment in the region by EUR 2 billion (USD 2.2 billion) per year.- Flcube.com<\/a><\/p>\n\n\n\n

<\/p>\n","protected":false},"excerpt":{"rendered":"

The European Commission (EC) is advancing an update to Europe’s 20-year-old pharmaceutical legislation, with the…<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"googlesitekit_rrm_CAownpewDA:productID":"","_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[4],"tags":[73],"class_list":["post-11179","post","type-post","status-publish","format-standard","hentry","category-policy-regulatory","tag-patents"],"yoast_head":"\nEuropean Commission Proposes Overhaul of Pharmaceutical Legislation - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"The European Commission (EC) is advancing an update to Europe's 20-year-old pharmaceutical legislation, with the dual goals of enhancing drug accessibility and bolstering research and development (R&D). The proposed changes have faced opposition from pharmaceutical associations, which argue that the new package shifts from fixed regulatory protection periods to a more flexible incentive-based system, prompting some companies to consider leaving the European market.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/flcube.com\/?p=11179\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"European Commission Proposes Overhaul of Pharmaceutical Legislation\" \/>\n<meta property=\"og:description\" content=\"Navigate the complexities of China\u2019s pharmaceutical industry with precision and clarity. FLCUBE delivers reliable data, news, and intelligence to broaden your horizons and sharpen your decision-making. Stay informed, stay ahead with FLCUBE.COM\" \/>\n<meta property=\"og:url\" content=\"https:\/\/flcube.com\/?p=11179\" \/>\n<meta property=\"og:site_name\" content=\"Insight, China's Pharmaceutical Industry\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/profile.php?id=61566606313834\" \/>\n<meta property=\"article:published_time\" content=\"2023-11-23T16:57:00+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-11-03T16:59:02+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/flcube.com\/wp-content\/uploads\/2024\/11\/Fineline-info-tech-scaled.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"2560\" \/>\n\t<meta property=\"og:image:height\" content=\"1894\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Fineline Cube\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Fineline Cube\" \/>\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:\\\/\\\/flcube.com\\\/?p=11179#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=11179\"},\"author\":{\"name\":\"Fineline Cube\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#\\\/schema\\\/person\\\/19ad11870d326204db8524d3c3c5e66a\"},\"headline\":\"European Commission Proposes Overhaul of Pharmaceutical Legislation\",\"datePublished\":\"2023-11-23T16:57:00+00:00\",\"dateModified\":\"2024-11-03T16:59:02+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=11179\"},\"wordCount\":254,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"},\"keywords\":[\"Patents\"],\"articleSection\":[\"Policy \\\/ Regulatory\"],\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=11179#respond\"]}],\"copyrightYear\":\"2023\",\"copyrightHolder\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"}},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=11179\",\"url\":\"https:\\\/\\\/flcube.com\\\/?p=11179\",\"name\":\"European Commission Proposes Overhaul of Pharmaceutical Legislation - Insight, China's Pharmaceutical Industry\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#website\"},\"datePublished\":\"2023-11-23T16:57:00+00:00\",\"dateModified\":\"2024-11-03T16:59:02+00:00\",\"description\":\"The European Commission (EC) is advancing an update to Europe's 20-year-old pharmaceutical legislation, with the dual goals of enhancing drug accessibility and bolstering research and development (R&D). The proposed changes have faced opposition from pharmaceutical associations, which argue that the new package shifts from fixed regulatory protection periods to a more flexible incentive-based system, prompting some companies to consider leaving the European market.\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=11179#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=11179\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=11179#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/flcube.com\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"European Commission Proposes Overhaul of Pharmaceutical Legislation\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#website\",\"url\":\"https:\\\/\\\/flcube.com\\\/\",\"name\":\"Insight, China's Pharmaceutical Industry\",\"description\":\"Fineline Insights, Pharma Clarity\",\"publisher\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/flcube.com\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"},{\"@type\":\"Organization\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\",\"name\":\"Fineline Infomation and Technology\",\"alternateName\":\"Fineline Info & Tech\",\"url\":\"https:\\\/\\\/flcube.com\\\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#\\\/schema\\\/logo\\\/image\\\/\",\"url\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2024\\\/11\\\/Fineline-info-tech-scaled.jpg\",\"contentUrl\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2024\\\/11\\\/Fineline-info-tech-scaled.jpg\",\"width\":2560,\"height\":1894,\"caption\":\"Fineline Infomation and Technology\"},\"image\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#\\\/schema\\\/logo\\\/image\\\/\"},\"sameAs\":[\"https:\\\/\\\/www.facebook.com\\\/profile.php?id=61566606313834\"]},{\"@type\":\"Person\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#\\\/schema\\\/person\\\/19ad11870d326204db8524d3c3c5e66a\",\"name\":\"Fineline Cube\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g\",\"url\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g\",\"contentUrl\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g\",\"caption\":\"Fineline Cube\"},\"sameAs\":[\"https:\\\/\\\/flcube.com\"],\"url\":\"https:\\\/\\\/flcube.com\\\/?author=1\"}]}<\/script>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"European Commission Proposes Overhaul of Pharmaceutical Legislation - Insight, China's Pharmaceutical Industry","description":"The European Commission (EC) is advancing an update to Europe's 20-year-old pharmaceutical legislation, with the dual goals of enhancing drug accessibility and bolstering research and development (R&D). The proposed changes have faced opposition from pharmaceutical associations, which argue that the new package shifts from fixed regulatory protection periods to a more flexible incentive-based system, prompting some companies to consider leaving the European market.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/flcube.com\/?p=11179","og_locale":"en_US","og_type":"article","og_title":"European Commission Proposes Overhaul of Pharmaceutical Legislation","og_description":"Navigate the complexities of China\u2019s pharmaceutical industry with precision and clarity. FLCUBE delivers reliable data, news, and intelligence to broaden your horizons and sharpen your decision-making. Stay informed, stay ahead with FLCUBE.COM","og_url":"https:\/\/flcube.com\/?p=11179","og_site_name":"Insight, China's Pharmaceutical Industry","article_publisher":"https:\/\/www.facebook.com\/profile.php?id=61566606313834","article_published_time":"2023-11-23T16:57:00+00:00","article_modified_time":"2024-11-03T16:59:02+00:00","og_image":[{"width":2560,"height":1894,"url":"https:\/\/flcube.com\/wp-content\/uploads\/2024\/11\/Fineline-info-tech-scaled.jpg","type":"image\/jpeg"}],"author":"Fineline Cube","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Fineline Cube","Est. reading time":"2 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/flcube.com\/?p=11179#article","isPartOf":{"@id":"https:\/\/flcube.com\/?p=11179"},"author":{"name":"Fineline Cube","@id":"https:\/\/flcube.com\/#\/schema\/person\/19ad11870d326204db8524d3c3c5e66a"},"headline":"European Commission Proposes Overhaul of Pharmaceutical Legislation","datePublished":"2023-11-23T16:57:00+00:00","dateModified":"2024-11-03T16:59:02+00:00","mainEntityOfPage":{"@id":"https:\/\/flcube.com\/?p=11179"},"wordCount":254,"commentCount":0,"publisher":{"@id":"https:\/\/flcube.com\/#organization"},"keywords":["Patents"],"articleSection":["Policy \/ Regulatory"],"inLanguage":"en-US","potentialAction":[{"@type":"CommentAction","name":"Comment","target":["https:\/\/flcube.com\/?p=11179#respond"]}],"copyrightYear":"2023","copyrightHolder":{"@id":"https:\/\/flcube.com\/#organization"}},{"@type":"WebPage","@id":"https:\/\/flcube.com\/?p=11179","url":"https:\/\/flcube.com\/?p=11179","name":"European Commission Proposes Overhaul of Pharmaceutical Legislation - Insight, China's Pharmaceutical Industry","isPartOf":{"@id":"https:\/\/flcube.com\/#website"},"datePublished":"2023-11-23T16:57:00+00:00","dateModified":"2024-11-03T16:59:02+00:00","description":"The European Commission (EC) is advancing an update to Europe's 20-year-old pharmaceutical legislation, with the dual goals of enhancing drug accessibility and bolstering research and development (R&D). The proposed changes have faced opposition from pharmaceutical associations, which argue that the new package shifts from fixed regulatory protection periods to a more flexible incentive-based system, prompting some companies to consider leaving the European market.","breadcrumb":{"@id":"https:\/\/flcube.com\/?p=11179#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/flcube.com\/?p=11179"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/flcube.com\/?p=11179#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/flcube.com\/"},{"@type":"ListItem","position":2,"name":"European Commission Proposes Overhaul of Pharmaceutical Legislation"}]},{"@type":"WebSite","@id":"https:\/\/flcube.com\/#website","url":"https:\/\/flcube.com\/","name":"Insight, China's Pharmaceutical Industry","description":"Fineline Insights, Pharma Clarity","publisher":{"@id":"https:\/\/flcube.com\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/flcube.com\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Organization","@id":"https:\/\/flcube.com\/#organization","name":"Fineline Infomation and Technology","alternateName":"Fineline Info & Tech","url":"https:\/\/flcube.com\/","logo":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/flcube.com\/#\/schema\/logo\/image\/","url":"https:\/\/flcube.com\/wp-content\/uploads\/2024\/11\/Fineline-info-tech-scaled.jpg","contentUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2024\/11\/Fineline-info-tech-scaled.jpg","width":2560,"height":1894,"caption":"Fineline Infomation and Technology"},"image":{"@id":"https:\/\/flcube.com\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/www.facebook.com\/profile.php?id=61566606313834"]},{"@type":"Person","@id":"https:\/\/flcube.com\/#\/schema\/person\/19ad11870d326204db8524d3c3c5e66a","name":"Fineline Cube","image":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/secure.gravatar.com\/avatar\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g","url":"https:\/\/secure.gravatar.com\/avatar\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g","caption":"Fineline Cube"},"sameAs":["https:\/\/flcube.com"],"url":"https:\/\/flcube.com\/?author=1"}]}},"jetpack_publicize_connections":[],"jetpack_featured_media_url":"","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/11179","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=11179"}],"version-history":[{"count":1,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/11179\/revisions"}],"predecessor-version":[{"id":11180,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/11179\/revisions\/11180"}],"wp:attachment":[{"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=11179"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=11179"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=11179"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}