{"id":163836,"date":"2025-12-03T03:00:02","date_gmt":"2025-12-03T02:00:02","guid":{"rendered":"https:\/\/www.cde.ual.es\/?p=163836"},"modified":"2025-12-02T12:19:16","modified_gmt":"2025-12-02T11:19:16","slug":"critical-medicines-act-council-agrees-its-position-on-new-rules-to-tackle-shortages","status":"publish","type":"post","link":"https:\/\/www.cde.ual.es\/en\/critical-medicines-act-council-agrees-its-position-on-new-rules-to-tackle-shortages\/","title":{"rendered":"Critical medicines act: Council agrees its position on new rules to tackle shortages"},"content":{"rendered":"<p style=\"text-align: justify;\">The Council has agreed its position on a new regulation that seeks to\u00a0<strong>strengthen the EU\u2019s resilience<\/strong>\u00a0in the face of ongoing challenges to security of supply of critical medicines in Europe.<\/p>\n<p style=\"text-align: justify;\">The critical medicines act (CMA) aims to\u00a0<strong>tackle shortages in key medicines<\/strong>\u00a0such as antibiotics, insulin and painkillers by improving security of supply and availability in the EU.<\/p>\n<p style=\"text-align: justify;\">The new rules incentivise\u00a0<strong>supply chain diversification<\/strong>, facilitate\u00a0<strong>collaborative procurement<\/strong>\u00a0models, and create incentives to boost\u00a0<strong>pharmaceutical manufacturing\u00a0<\/strong>in EU countries.<\/p>\n<p><img decoding=\"async\" class=\"aligncenter\" src=\"https:\/\/www.cde.ual.es\/wp-content\/uploads\/2025\/12\/pexels-pixabay-139398-scaled.jpg\" width=\"576\" height=\"384\" \/><\/p>\n<h3 style=\"text-align: justify;\"><strong>The Council&#8217;s position<\/strong><\/h3>\n<p style=\"text-align: justify;\">The main changes introduced by the Council relate to the\u00a0<strong>procurement of critical medicines<\/strong>\u00a0and their active ingredients. In its position, the Council has:<\/p>\n<ul style=\"text-align: justify;\">\n<li>introduced a requirement for the Commission to\u00a0<strong>issue guidance<\/strong>, including to help member states determine whether a critical medicine or active ingredient has been\u00a0<strong>produced in the EU<\/strong><\/li>\n<li>facilitated the exchange of information<strong>\u00a0<\/strong>on\u00a0<strong>contingency stocks of medicinal products<\/strong><\/li>\n<li>streamlined the provisions on\u00a0<strong>collaborative procurement<\/strong>\u00a0and reduced (from nine to six) the\u00a0<strong>minimum number of member states<\/strong>\u00a0needed to submit a joint request to the Commission<\/li>\n<li>added an obligation to use\u00a0<strong>criteria relating to resilience<\/strong>\u00a0in the public procurement of critical medicines<\/li>\n<li>improved the legal clarity and coherence of the regulation by\u00a0<strong>aligning its terminology<\/strong>\u00a0with that of the\u00a0<strong>public procurement directive<\/strong><\/li>\n<\/ul>\n<h3 style=\"text-align: justify;\">Next steps<\/h3>\n<p style=\"text-align: justify;\">Once the European Parliament has established its position, the two institutions will enter into negotiations to agree on the final text.<\/p>\n<h3 style=\"text-align: justify;\">Background<\/h3>\n<p style=\"text-align: justify;\">In recent years, the EU has increasingly faced severe shortages of key medicines such as antibiotics, insulin and painkillers. On 11 March 2025, the Commission sought to address these issues by publishing a proposal for a \u2018critical medicines act\u2019 (CMA).<\/p>\n<p style=\"text-align: justify;\">The CMA complements the proposals to revise the EU\u2019s pharmaceutical legislation (the \u2018pharmaceutical package\u2019), which also contain provisions on shortages and management of supply of medicinal products.<\/p>\n<p style=\"text-align: justify;\"><strong>More information: <a href=\"https:\/\/www.consilium.europa.eu\/es\/press\/press-releases\/2025\/12\/02\/critical-medicines-act-council-agrees-its-position-on-new-rules-to-tackle-shortages\/\">Council of the EU<\/a><\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The Council has agreed its position on a new regulation that seeks to\u00a0strengthen the EU\u2019s resilience\u00a0in the face of ongoing challenges to security of supply of critical medicines in Europe. The critical medicines act (CMA) aims to\u00a0tackle shortages in key medicines\u00a0such as antibiotics, insulin and painkillers by improving security of supply and availability in the [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":163838,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_relevanssi_hide_post":"","_relevanssi_hide_content":"","_relevanssi_pin_for_all":"","_relevanssi_pin_keywords":"","_relevanssi_unpin_keywords":"","_relevanssi_related_keywords":"","_relevanssi_related_include_ids":"","_relevanssi_related_exclude_ids":"","_relevanssi_related_no_append":"","_relevanssi_related_not_related":"","_relevanssi_related_posts":"","_relevanssi_noindex_reason":"","_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"_genesis_hide_title":false,"_genesis_hide_breadcrumbs":false,"_genesis_hide_singular_image":false,"_genesis_hide_footer_widgets":false,"_genesis_custom_body_class":"","_genesis_custom_post_class":"","_genesis_layout":"","footnotes":""},"categories":[346,4094,4092],"tags":[7367,368,1685,2788,16587,3200,16586,1677],"class_list":{"0":"post-163836","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-eu-news","8":"category-farmac","9":"category-health","10":"tag-council-of-the-eu-en","11":"tag-european-union","12":"tag-medicines","13":"tag-news","14":"tag-pharmaceutical-manufacturing","15":"tag-regulation","16":"tag-shortage","17":"tag-supply-chain","18":"entry"},"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Critical medicines act: Council agrees its position on new rules to tackle shortages | CDE Almer\u00eda - Centro de Documentaci\u00f3n Europea - Universidad de Almer\u00eda<\/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:\/\/www.cde.ual.es\/?p=163844\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Critical medicines act: Council agrees its position on new rules to tackle shortages | CDE Almer\u00eda - Centro de Documentaci\u00f3n Europea - Universidad de Almer\u00eda\" \/>\n<meta property=\"og:description\" content=\"The Council has agreed its position on a new regulation that seeks to\u00a0strengthen the EU\u2019s resilience\u00a0in the face of ongoing challenges to security of supply of critical medicines in Europe. 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