{"id":166318,"date":"2025-11-29T17:11:08","date_gmt":"2025-11-29T17:11:08","guid":{"rendered":"https:\/\/www.newsbeep.com\/ie\/166318\/"},"modified":"2025-11-29T17:11:08","modified_gmt":"2025-11-29T17:11:08","slug":"novo-nordisk-warns-eu-loophole-may-fuel-fake-ozempic-trade-pharmacists-push-back","status":"publish","type":"post","link":"https:\/\/www.newsbeep.com\/ie\/166318\/","title":{"rendered":"Novo Nordisk warns EU loophole may fuel fake Ozempic trade, pharmacists push back"},"content":{"rendered":"<p>Danish drugmaker Novo Nordisk has warned that new EU rules could allow some pharmacies to compound their own, unauthorised versions of weight-loss medications \u2013 but a major pharmacist group insists it\u2019s a false alarm.\u00a0<\/p>\n<p>According to a Novo spokesperson, an important loophole has emerged in the EU\u2019s sweeping overhaul of its pharmaceutical legislation: certain pharmacies could be permitted to mix specific medicines, including versions of the company\u2019s blockbuster weight-loss drugs Ozempic and Wegovy. \u00a0<\/p>\n<p>\u201cOpening the doors to large-scale unregulated medicines that bypass the strict standards designed to keep patients safe would create a Wild West,\u201d the spokesperson told Euractiv. \u00a0<\/p>\n<p>They added that the revisions \u201cwould allow pharmacists to stockpile, filling their shelves with product in anticipation of prescriptions rather than waiting for individual prescriptions.\u201d\u00a0<\/p>\n<p>Currently, pharmacies may prepare compounded doses of medicines only in limited cases, such as during shortages or when lower-dose\u00a0options aren\u2019t available for children.<\/p>\n<p>False alarm on fake medication?<\/p>\n<p>But Ilaria Passarini, secretary general of the Pharmaceutical Group of the European Union (PGEU), which represents more than 400,000 community pharmacists, said Novo\u2019s warning that pharmacies would be able to manufacture drugs more broadly as \u2018parallel production\u2019 is a false alarm.<\/p>\n<p>\u201cIt\u2019s\u00a0pure\u00a0madness,\u201d she said.\u00a0\u201cThe claims circulating that the revision would enable pharmacies to mass-produce or stockpile unregulated medicines, including complex injectables like GLP-1 analogues, are simply wrong.\u201d<\/p>\n<p>Community pharmacies, in particular, are \u201cnot asking to change or expand EU rules on compounding,\u201d she said.\u00a0<\/p>\n<p>Industry has raised the alarm on a potential change in law that could allow large-scale pharmacies to prepare a few weeks\u2019 worth of customised medicines in advance.<\/p>\n<p>Third-party gateway<\/p>\n<p>Novo Nordisk also fears that the new legislation could boost an already large, online third-party marketplace. In September, the European Medicines Agency (EMA) <a href=\"https:\/\/www.euractiv.com\/news\/sharp-rise-in-fake-weight-loss-drugs-sold-online-warn-eu-regulators\/\" rel=\"nofollow noopener\" target=\"_blank\">warned of a \u201csharp rise\u201d in counterfeit medicines<\/a> marketed and sold as GLP-1 agonists.\u00a0<\/p>\n<p>\u201cIf compounding restrictions in the EU are relaxed, it is highly likely that this unlicensed and unregulated supply chain will start to find its way to patients through legitimate pharmacies,\u201d the Novo spokesperson explained.\u00a0\u00a0<\/p>\n<p>Passarini countered that the current debate is about preserving \u201csmall-scale, need-driven\u201d compounding in community settings, not \u201copening the door to copycat versions of innovative biologics.\u201d<\/p>\n<p>EU countries and lawmakers are still negotiating the pharma package, with a deal expected in December.\u00a0 Euractiv understands that the loophole could have been closed in more recent talks.<\/p>\n<p>(bms, aw)<\/p>\n","protected":false},"excerpt":{"rendered":"Danish drugmaker Novo Nordisk has warned that new EU rules could allow some pharmacies to compound their own,&hellip;\n","protected":false},"author":2,"featured_media":166319,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[33],"tags":[103,61,60,371],"class_list":{"0":"post-166318","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-medication","8":"tag-health","9":"tag-ie","10":"tag-ireland","11":"tag-medication"},"_links":{"self":[{"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/posts\/166318","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/comments?post=166318"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/posts\/166318\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/media\/166319"}],"wp:attachment":[{"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/media?parent=166318"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/categories?post=166318"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/tags?post=166318"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}