{"id":15609,"date":"2023-05-03T00:00:00","date_gmt":"2023-05-03T00:00:00","guid":{"rendered":"https:\/\/makingpharmaindustry.it\/non-categorizzato\/hera-reports-on-stockpiling-of-antimicrobials\/"},"modified":"2023-08-28T12:30:58","modified_gmt":"2023-08-28T12:30:58","slug":"hera-reports-on-stockpiling-of-antimicrobials","status":"publish","type":"post","link":"https:\/\/makingpharmaindustry.it\/en\/eipg-news\/hera-reports-on-stockpiling-of-antimicrobials\/","title":{"rendered":"HERA reports on stockpiling of antimicrobials"},"content":{"rendered":"\r\n<p>The <em>Health Emergency Preparedness and Response Authority <\/em>(HERA) has published two final reports for the European Commission, describing respectively the results obtained during the first and second phases of the <strong>antimicrobial resistance (AMR) feasibility study on stockpiling<\/strong>.<\/p>\r\n\r\n\r\n\r\n<p>Antibiotic resistance represents a major threat for human health, as many active substances are losing efficacy towards many bacterial species. The <strong>first report<\/strong> aims to assessing the current situation, identifying vulnerabilities and reviewing the stockpiling systems currently available in the EU. The <strong>second report <\/strong>discusses the vulnerabilities identified in the previous one and the potential tools and solutions to address them.<\/p>\r\n\r\n\r\n\r\n<p>To read the report\u2019s contents in-depth please visit the <a href=\"https:\/\/eipg.eu\/hera-reports-on-stockpiling-of-antimicrobials\/\" target=\"_blank\" rel=\"noreferrer noopener\">EIPG website<\/a>, while here you can find a short resume of the two reports.<\/p>\r\n\r\n\r\n\r\n<h3 class=\"wp-block-heading\">First report<\/h3>\r\n\r\n\r\n\r\n<ul class=\"wp-block-list\">\r\n<li>32 classes od antibiotics were identified as critical<\/li>\r\n\r\n\r\n\r\n<li>20 substances were indicated as specially relevant as first- or last-live\/reserve therapies against AMR pathogens<\/li>\r\n\r\n\r\n\r\n<li>13 substances were identified as las-line\/reserve therapies for severe and potentially lethal infections<\/li>\r\n<\/ul>\r\n\r\n\r\n\r\n<p>For what concern stockpiling at the EU level it might not have a direct impact on the mitigation of market-driven trends; improved monitoring of potentially critical future withdrawals would be needed to enable early detection of shortages and establishment of counteractions. <strong>Innovation in the field of new antibiotics is still largely insufficient<\/strong>, with only six substances currently in phase 3 clinical development. The report also highlights that the analysis of supply chain vulnerabilities was \u201csignificantly limited by a <strong>lack of outside-in transparency<\/strong>\u201d.<\/p>\r\n\r\n\r\n\r\n<h3 class=\"wp-block-heading\">Second report<\/h3>\r\n\r\n\r\n\r\n<p>In the second report <strong>all the above-mentioned observations are deeper analyzed<\/strong> from different perspectives and possible approaches to the stockpiling of antibiotics are targeted. A sudden and unpredictable surge in demand and an interruption to supply are the two archetypes analyzed to better identify how to address stockpiling.<\/p>\r\n\r\n\r\n\r\n<p>The following warning is a significant extract from the report:<\/p>\r\n\r\n\r\n\r\n<blockquote class=\"wp-block-quote has-text-align-center td_pull_quote td_pull_center is-layout-flow wp-block-quote-is-layout-flow\">\u201c<em>stockpiling is just a short-term mechanism. It does not alter the fundamental market environment. It can only represent one part of any answer to the challenges faced by health agencies including HERA whether AMR-related or otherwise\u201d<\/em><\/blockquote>\r\n","protected":false},"excerpt":{"rendered":"<p>Antibiotic resistance represents a major threat for human health, as many active substances are losing efficacy towards many bacterial species.<\/p>\n","protected":false},"author":32,"featured_media":15908,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[687],"tags":[858,705,693,859],"class_list":{"0":"post-15609","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-eipg-news","8":"tag-amr-en","9":"tag-antimicrobial-resistance","10":"tag-regulatory","11":"tag-supply-chain-en"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.2 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>HERA reports on stockpiling of antimicrobials - 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