{"id":56852,"date":"2025-11-24T14:58:18","date_gmt":"2025-11-24T13:58:18","guid":{"rendered":"https:\/\/setterwalls.se\/?post_type=articles&#038;p=56852"},"modified":"2025-12-02T11:38:10","modified_gmt":"2025-12-02T10:38:10","slug":"setterwalls-life-science-report-november-2025","status":"publish","type":"articles","link":"https:\/\/setterwalls.se\/en\/article\/setterwalls-life-science-report-november-2025\/","title":{"rendered":"Setterwalls Life Sciences Report November 2025"},"content":{"rendered":"    <section class=\"block text bg-white\">\n        <div class=\"container container-sm\">\n            <div class=\"row\">\n                <div class=\"col-12\">\n                    <div class=\"editor-content\">\n                                                <p><strong>We have the pleasure of presenting the latest issue of Setterwalls\u2019 Life Sciences report. The report presents our view on selected current issues with respect to life sciences.\u00a0<\/strong><\/p>\n<p>In this issue you can read about for example updates in the ethical rules, labelling\u00a0of foods for special medical purposes and Sweden\u2019s adaptations to the AI Act. We hope you will find the report of interest.<\/p>\n<p>The report contains the following articles:<\/p>\n<ul>\n<li>Updates in the ethical rules \u2013 how are pharmaceutical companies affected?<\/li>\n<li>EU Court clarifies front\u2011of\u2011pack nutrition labelling for foods for special medical purposes: per\u2011portion figures included in such labelling constitute a prohibited repetition<\/li>\n<li>A closer look at MDCG 2025-4 guidance for medical software apps<\/li>\n<li>Do not call it probiotics<\/li>\n<li>Proposal for a new Swedish product liability act \u2013 what does that mean?<\/li>\n<li>A brief update on Sweden\u2019s adaptations to the AI Act \u2013 SOU 2025:101<\/li>\n<li>Two Judgments on Sales of Alcoholic Beverages in Sweden on Producers\u2019 Sites \u2013 Opening Hours Are Not Required to Match Those of Systembolaget<\/li>\n<\/ul>\n<h6>Content:<\/h6>\n<h4>Updates in the ethical rules \u2013 how are pharmaceutical companies affected?<\/h4>\n<p>At the end of September this year, several updates to the Ethical Rules for the Pharmaceutical Industry in Sweden (LER) entered into force. The rules are binding on member companies of the Swedish Association of the Pharmaceutical Industry (Lif). While the rules have previously been updated at relatively frequent intervals, a longer period has now passed since the last amendments were made. In this article, Setterwalls summarises the changes and their impact on pharmaceutical companies.<\/p>\n<p><a href=\"https:\/\/setterwalls.se\/en\/article\/updates-in-the-ethical-rules-how-are-pharmaceutical-companies-affected\/\" target=\"_blank\" rel=\"noopener\"><strong>Read more.<\/strong><\/a><\/p>\n<p>&nbsp;<\/p>\n<h4>EU Court clarifies front\u2011of\u2011pack nutrition labelling for foods for special medical purposes: per\u2011portion figures included in such labelling constitute a prohibited repetition<\/h4>\n<p>The European Court of Justice clarifies front\u2011of\u2011pack nutrition labelling requirements for foods for special medical purposes \u2013 here are the main takeaways.<\/p>\n<p><a href=\"https:\/\/setterwalls.se\/en\/article\/eu-court-clarifies-front%e2%80%91of%e2%80%91pack-nutrition-labelling-for-foods-for-special-medical-purposes-per%e2%80%91portion-figures-included-in-such-labelling-constitute-a-prohibited-repetition\/\" target=\"_blank\" rel=\"noopener\"><strong>Read more.<\/strong><\/a><\/p>\n<p>&nbsp;<\/p>\n<h4>A closer look at MDCG 2025-4 guidance for medical software apps<\/h4>\n<p>In June 2025, the Medical Device Coordination Group (MDCG) issued guidance document MDCG 2025-4, a pivotal development for digital health regulation in the European Union. This guidance responds to the growing prevalence of medical device software (MDSW) apps released through online platforms. The framework addresses patient safety, regulatory compliance and transparency obligations related to MDSW apps and their distribution channels.<\/p>\n<p><a href=\"https:\/\/setterwalls.se\/en\/article\/a-closer-look-at-mdcg-2025-4-guidance-for-medical-software-apps\/\" target=\"_blank\" rel=\"noopener\"><strong>Read more.<\/strong><\/a><\/p>\n<p>&nbsp;<\/p>\n<h4>Do not call it probiotics<\/h4>\n<p>Marketing products and services in the Life Sciences field is not a simple task. In addition to the general marketing law rules that apply to all goods and services, there is a rich array of special regulations to consider, for example regarding medicinal products and foods.<\/p>\n<p><a href=\"https:\/\/setterwalls.se\/en\/article\/do-not-call-it-probiotics\/\" target=\"_blank\" rel=\"noopener\"><strong>Read more.<\/strong><\/a><\/p>\n<p>&nbsp;<\/p>\n<h4>Proposal for a new Swedish product liability act \u2013 what does that mean?<\/h4>\n<p>The existing regulations on product liability for consumer protection were designed way before the current digital environment came into being. To align the regulations with the digital era, new rules are on their way. In this article, Setterwalls summarises some of the implications these changes may have on the Life Sciences sector.<\/p>\n<p><a href=\"https:\/\/setterwalls.se\/en\/article\/proposal-for-a-new-swedish-product-liability-act-what-does-it-mean\/\" target=\"_blank\" rel=\"noopener\"><strong>Read more.<\/strong><\/a><\/p>\n<p>&nbsp;<\/p>\n<h4>A brief update on Sweden\u2019s adaptations to the AI Act \u2013 SOU 2025:101<\/h4>\n<p>In October 2025, the Swedish inquiry (SOU 2025:101) (\u201cSOU\u201d) aiming to investigate the measures necessary to implement the Artificial Intelligence Act, Regulation (EU) 2024\/1689 (\u201cthe AI Act\u201d or \u201cthe Act\u201d), delivered its report. The aim of the inquiry was, among other things, to clarify how responsibilities should be shared between national authorities, to submit proposals on what is needed to meet the requirements for sanctions in the event of violations of the Act and to analyse what is needed to establish regulatory sandboxes for AI.<\/p>\n<p><a href=\"https:\/\/setterwalls.se\/en\/article\/a-brief-update-on-swedens-adaptations-to-the-ai-act-sou-2025101-2\/\" target=\"_blank\" rel=\"noopener\"><strong>Read more.<\/strong><\/a><\/p>\n<p>&nbsp;<\/p>\n<h4>Two Judgments on Sales of Alcoholic Beverages in Sweden on Producers\u2019 Sites \u2013 Opening Hours Are Not Required to Match Those of Systembolaget<\/h4>\n<p>Following the June 2025 legalisation of on\u2011site sales of alcoholic beverages at producers\u2019\u00a0premises in Sweden, judgments on the first cases under the new framework have now been issued. On 23 October 2025, the Administrative Court in Stockholm examined permissible sales hours in the light of local conditions, and granted permits for the sale of spirits also on non\u2011holiday Saturdays from 3.00 p.m. to 8.00 p.m. and on Sundays and public holidays from 10.00 a.m. to 8.00 p.m.<\/p>\n<p><a href=\"https:\/\/setterwalls.se\/en\/article\/two-judgments-on-sales-of-alcoholic-beverages-in-sweden-on-producers-sites-opening-hours-are-not-required-to-match-those-of-systembolaget\/\" target=\"_blank\" rel=\"noopener\"><strong>Read more.<\/strong><\/a><\/p>\n                    <\/div>\n                <\/div>\n            <\/div>\n        <\/div>\n    <\/section>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":16,"featured_media":56832,"template":"","meta":{"_acf_changed":true,"_seopress_robots_primary_cat":"","_seopress_titles_title":"","_seopress_titles_desc":"","_seopress_robots_index":""},"article_category":[1058],"class_list":["post-56852","articles","type-articles","status-publish","has-post-thumbnail","hentry","article_category-life-sciences-en"],"acf":[],"_links":{"self":[{"href":"https:\/\/setterwalls.se\/en\/wp-json\/wp\/v2\/articles\/56852","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/setterwalls.se\/en\/wp-json\/wp\/v2\/articles"}],"about":[{"href":"https:\/\/setterwalls.se\/en\/wp-json\/wp\/v2\/types\/articles"}],"author":[{"embeddable":true,"href":"https:\/\/setterwalls.se\/en\/wp-json\/wp\/v2\/users\/16"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/setterwalls.se\/en\/wp-json\/wp\/v2\/media\/56832"}],"wp:attachment":[{"href":"https:\/\/setterwalls.se\/en\/wp-json\/wp\/v2\/media?parent=56852"}],"wp:term":[{"taxonomy":"article_category","embeddable":true,"href":"https:\/\/setterwalls.se\/en\/wp-json\/wp\/v2\/article_category?post=56852"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}