{"id":44884,"date":"2026-08-19T17:12:47","date_gmt":"2026-08-19T15:12:47","guid":{"rendered":"https:\/\/lexcase.com\/?p=44884"},"modified":"2026-08-19T17:12:47","modified_gmt":"2026-08-19T15:12:47","slug":"healthcare-an-analysis-of-the-wave-of-sanctions-against-wholesale-distributors-by-the-ansm","status":"publish","type":"post","link":"https:\/\/lexcase.com\/en\/healthcare-an-analysis-of-the-wave-of-sanctions-against-wholesale-distributors-by-the-ansm\/","title":{"rendered":"Healthcare : An analysis of the wave of sanctions against wholesale distributors by the ANSM"},"content":{"rendered":"<p>In July, the ANSM issued two new sanctions against pharmaceutical wholesale distributors. Another wholesale distributor had already been sanctioned in March.<\/p>\n<p>These sanctions follow a series of inspections of wholesale distributors that resulted in several formal orders, marking a return to financial penalties in this area after a hiatus since 2022.<\/p>\n<p>These sanctions confirm the ANSM\u2019s interpretation of the concept of the public service obligation (hereinafter &#8220;PSO&#8221;) and provide insight into the procedures involved.<\/p>\n<h2>1. The concept of the public service obligation<\/h2>\n<p>As a reminder, the PSO entails, in particular, the following delivery obligations:<\/p>\n<ul>\n<li>Up to Saturday at 2:00 PM: Delivering, within 24 hours, any order for any presentation of medicinal products actually marketed\u2014subject to certain exceptions and adjustments.<\/li>\n<li>Saturdays from 2:00 PM, Sundays, and public holidays: Participating in an inter-company on-call system enabling the delivery of medicines within required timeframes, and no later than 8 hours.<\/li>\n<\/ul>\n<p>Furthermore, wholesale distributors may only sell medicines outside the national territory or to export wholesalers (hereinafter &#8220;DGEs&#8221;) once they have fulfilled their PSOs. Export activities must not compromise the availability of medicines in France\u2014a practice generally associated with maintaining a limited stock range, known as &#8220;shortlining.&#8221;<\/p>\n<p>The ANSM once again demonstrates its firm stance against the practice known as &#8220;shortlining.&#8221;<\/p>\n<p>Consequently, the ANSM adopts a tolerant approach toward marketing authorization holders, who may refuse sales to, or ration supplies for, wholesale distributors in order to limit their export capacity. Indications of non-compliance:<\/p>\n<p>In its decision of June 18, the ANSM deemed the following to constitute a failure to meet the Public Service Obligation (OSP):<\/p>\n<ul>\n<li>insufficient personnel and logistical resources<\/li>\n<li>the expiration of virtually the entire stock of medicines classified as narcotics<\/li>\n<\/ul>\n<p>In its decision of July 6, the ANSM deemed the following to constitute a failure to meet the OSP:<\/p>\n<ul>\n<li>closure of the facility on Saturday mornings<\/li>\n<li>refusal to fill orders from community pharmacies for medicines that were, however, being distributed to a specialized distributor (DGE)<\/li>\n<li>refusal to deliver stock in favor of exporting it, limited product range diversity, and minimal stock depth (ranging from 1 to 5 boxes per product).<\/li>\n<\/ul>\n<p>Although this second sanction reveals that the number of listed products falls far short of the requirement to stock nine-tenths of available presentations, the ANSM did not explicitly cite this specific rule.<\/p>\n<p>It is worth noting that certain violations cited in the injunction published on December 15, 2025, were not included in the sanction\u2014specifically those regarding non-compliance with obligations concerning the personal involvement of the responsible pharmacist and pharmaceutical accountability.<\/p>\n<p>It therefore appears that some of the violations may have been partially resolved through measures taken following the inspection.<\/p>\n<h2>2. Procedure<\/h2>\n<p><strong>Timelines:<\/strong><\/p>\n<p>An analysis of the three sanctions reveals significant disparities in the timeframes involved in the procedure.<\/p>\n<p>While 1.5 years elapsed between the inspection and the publication of the financial sanctions for the decisions of March 19 and June 18, 2026, the decision of July 6, 2026, was published 2.5 years after the inspection\u2014with a gap of one year and three months between the communication of the draft sanction and its publication.<\/p>\n<p>Sanctioned party:<\/p>\n<p>Given that:<\/p>\n<ul>\n<li>the responsible pharmacist is personally liable for compliance with provisions governing their activities, without prejudice\u2014where applicable\u2014to the joint and several liability of the company;<\/li>\n<li>the ANSM initiates financial sanction proceedings against the &#8220;parties responsible for the breaches&#8221;\u2014defined as &#8220;natural or legal persons manufacturing or marketing products referred to in Article L. 5311-1 or providing services associated with such products&#8221;;<br \/>\n\u279c all sanctions were imposed solely on the legal entity.<\/li>\n<\/ul>\n<p>This applies even in the case of the sanction from last March, which penalized &#8220;the failure of a responsible pharmacist or a deputy pharmacist to personally practice their profession.&#8221;<\/p>\n<p>The ANSM therefore appears to systematically target the legal entity.<\/p>\n<p><strong>Amounts:<\/strong><\/p>\n<p>For a legal entity, the sanction is capped at 10% of the turnover generated during the last closed financial year, subject to a maximum of one million euros. Through adjustment mechanisms, the sanction imposed in the two cases published in July was reduced to 4% of turnover.<\/p>\n<p>In light of the injunctions issued in 2025 against wholesale distributors, further financial sanctions may be expected this year. This is a critical issue given the supply shortages in France.<\/p>\n<p style=\"margin-top: 30px; margin-bottom: 0;\"><strong><em><br \/>\n<\/em><br \/>\n<\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"<p>In July, the ANSM issued two new sanctions against pharmaceutical wholesale distributors. Another wholesale distributor had already been sanctioned in March. These sanctions follow a series of inspections of wholesale distributors that resulted in several formal orders, marking a return to financial penalties in this area after a hiatus since 2022. These sanctions confirm the [&hellip;]<\/p>\n","protected":false},"author":10,"featured_media":33663,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[99],"tags":[],"class_list":["post-44884","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-life-science-en"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Healthcare : An analysis of the wave of sanctions against wholesale distributors by the ANSM - LexCase<\/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:\/\/lexcase.com\/en\/healthcare-an-analysis-of-the-wave-of-sanctions-against-wholesale-distributors-by-the-ansm\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Healthcare : An analysis of the wave of sanctions against wholesale distributors by the ANSM - LexCase\" \/>\n<meta property=\"og:description\" content=\"In July, the ANSM issued two new sanctions against pharmaceutical wholesale distributors. 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