{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,4,9]],"date-time":"2025-04-09T09:33:24Z","timestamp":1744191204058,"version":"3.38.0"},"reference-count":0,"publisher":"SAGE Publications","issue":"2","license":[{"start":{"date-parts":[[2020,4,1]],"date-time":"2020-04-01T00:00:00Z","timestamp":1585699200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"funder":[{"DOI":"10.13039\/501100004733","name":"Universidade de Macau","doi-asserted-by":"publisher","award":["Grant MYRG2015-00008-FLL"],"award-info":[{"award-number":["Grant MYRG2015-00008-FLL"]}],"id":[{"id":"10.13039\/501100004733","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Maastricht Journal of European and Comparative Law"],"published-print":{"date-parts":[[2020,4]]},"abstract":"<jats:p> In the Novartis Farma SpA case (Case C-29\/17), the Court of Justice of the European Union (CJEU) held that the decision of a Member State (Italy) to reimburse a drug used off-label (Avastin), and for that purpose submitted to repacking procedures, is not in violation of European law, even if there is a duly approved therapeutic alternative (Lucentis) on the market and the procedure is solely to reduce health care expenditures. <\/jats:p><jats:p> This was not the CJEU\u2019s first ruling on off-label drug use. The novelty of the Novartis Farma SpA case is the economic element attached to the assessment of off-label prescriptions, even though the Court failed to consider this essential feature of the case. <\/jats:p><jats:p> This paper analyses the Court\u2019s ruling in light of two main principles of European pharmaceutical law: the imposition of marketing authorization for drugs used in the European market; and the predominance of public health concerns over economic considerations. The paper concludes that the Court failed to identify a major issue in the Italian policy \u2013 the reimbursement of off-label drug used when there is a properly approved therapeutic alternative on the market \u2013 at the risk of undermining the entire European pharmaceutical framework and endangering public health. <\/jats:p>","DOI":"10.1177\/1023263x20904228","type":"journal-article","created":{"date-parts":[[2020,4,2]],"date-time":"2020-04-02T16:30:32Z","timestamp":1585845032000},"page":"178-198","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":2,"title":["The CJEU\u2019s ruling in the <i>Novartis Farma<\/i> case: Money, health and medicines"],"prefix":"10.1177","volume":"27","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7895-2181","authenticated-orcid":false,"given":"Vera L\u00facia","family":"Raposo","sequence":"first","affiliation":[{"name":"Faculty of Law, Macao University, Macao, China"}]}],"member":"179","published-online":{"date-parts":[[2020,4,2]]},"container-title":["Maastricht Journal of European and Comparative Law"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/1023263X20904228","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/1023263X20904228","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/1023263X20904228","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,3,2]],"date-time":"2025-03-02T03:59:18Z","timestamp":1740887958000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/1023263X20904228"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,4]]},"references-count":0,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2020,4]]}},"alternative-id":["10.1177\/1023263X20904228"],"URL":"https:\/\/doi.org\/10.1177\/1023263x20904228","relation":{},"ISSN":["1023-263X","2399-5548"],"issn-type":[{"type":"print","value":"1023-263X"},{"type":"electronic","value":"2399-5548"}],"subject":[],"published":{"date-parts":[[2020,4]]}}}