{"?xml":{"@version":"1.0"},"edm:RDF":{"@xmlns:dc":"http://purl.org/dc/elements/1.1/","@xmlns:edm":"http://www.europeana.eu/schemas/edm/","@xmlns:wgs84_pos":"http://www.w3.org/2003/01/geo/wgs84_pos","@xmlns:foaf":"http://xmlns.com/foaf/0.1/","@xmlns:rdaGr2":"http://rdvocab.info/ElementsGr2","@xmlns:oai":"http://www.openarchives.org/OAI/2.0/","@xmlns:owl":"http://www.w3.org/2002/07/owl#","@xmlns:rdf":"http://www.w3.org/1999/02/22-rdf-syntax-ns#","@xmlns:ore":"http://www.openarchives.org/ore/terms/","@xmlns:skos":"http://www.w3.org/2004/02/skos/core#","@xmlns:dcterms":"http://purl.org/dc/terms/","edm:WebResource":[{"@rdf:about":"http://www.dlib.si/stream/URN:NBN:SI:DOC-TIVKPR1I/640824f4-7e4e-4d0a-a5fb-1e59aef53b0f/PDF","dcterms:extent":"538 KB"},{"@rdf:about":"http://www.dlib.si/stream/URN:NBN:SI:DOC-TIVKPR1I/6bcf92d6-50fc-4245-b3ce-da07b4f193d5/TEXT","dcterms:extent":"81 KB"}],"edm:TimeSpan":{"@rdf:about":"2015-2026","edm:begin":{"@xml:lang":"en","#text":"2015"},"edm:end":{"@xml:lang":"en","#text":"2026"}},"edm:ProvidedCHO":{"@rdf:about":"URN:NBN:SI:DOC-TIVKPR1I","dcterms:isPartOf":[{"@rdf:resource":"https://www.dlib.si/details/URN:NBN:SI:spr-M1DCQYMN"},{"@xml:lang":"sl","#text":"Medicine, law & society"}],"dcterms:issued":"2026","dc:creator":["Brndušić, Nina","Samec Berghaus, Nataša"],"dc:format":[{"@xml:lang":"sl","#text":"letnik:19"},{"@xml:lang":"sl","#text":"številka:2"},{"@xml:lang":"sl","#text":"str. 445–476"}],"dc:identifier":["DOI:10.18690/mls.19.2.445-476.2026","ISSN:2463-7955","COBISSID_HOST:294763523","URN:URN:NBN:SI:doc-TIVKPR1I"],"dc:language":"en","dc:publisher":{"@xml:lang":"sl","#text":"University of Maribor Press"},"dc:subject":[{"@xml:lang":"en","#text":"causation"},{"@xml:lang":"en","#text":"comparative law"},{"@xml:lang":"en","#text":"medicinal products"},{"@xml:lang":"en","#text":"pharmaceutical liability"},{"@xml:lang":"en","#text":"pharmacovigilance"},{"@xml:lang":"en","#text":"product liability"},{"@xml:lang":"en","#text":"tort law"}],"dcterms:temporal":{"@rdf:resource":"2015-2026"},"dc:title":{"@xml:lang":"sl","#text":"Pharmaceutical liability for unexpected adverse drug reactions| a comparative study of Slovenian and German law|"},"dc:description":[{"@xml:lang":"sl","#text":"Medicinal products are vital to healthcare, yet their use entails unavoidable risks, especially unexpected adverse drug reactions. This article examines how Slovenian and German law allocate civil liability for such harm and what implications arise for injured persons. It argues that Slovenia’s framework is normatively sound but fragmented, with evidentiary support for claimants underdeveloped, whereas Germany’s is more coherent and claimant-oriented. Both rely on strict liability and continuous pharmacovigilance but diverge in evidentiary and institutional design. Using a doctrinal-comparative method, the article analyses Slovenian and German statutes in light of Product Liability Directive (EU) 2024/2853. It finds that Slovenian law lacks key safeguards, including an express, sector-specific presumption of causation and a statutory right of access to safety data, and imposes no insurance duty. German law offers clearer rules, procedural support, and mandatory financial coverage. The Directive's innovations point toward a more claimant-friendly model, offering Slovenia an opportunity for reform"},{"@xml:lang":"sl","#text":"Zdravila so ključnega pomena za zdravstveno varstvo, vendar njihova uporaba prinaša neizogibna tveganja, zlasti nepričakovane neželene učinke zdravil. Članek preučuje, kako slovenska in nemška zakonodaja urejata civilno odgovornost za takšno škodo in kakšne posledice lahko ima to za oškodovance. Članek zagovarja, da je slovenski pravni okvir normativno ustrezen, a razdrobljen, pri čemer je dokazna podpora za tožnike premalo razvita, medtem ko je nemški okvir bolj koherenten in usmerjen v tožnike. Oba sistema temeljita na objektivni odgovornosti in stalni farmakovigilanci, vendar se razlikujeta v dokazni ureditvi in institucionalni zasnovi. S pomočjo doktrinarno-primerjalne metode članek analizira slovenske in nemške zakone v luči Direktive o odgovornosti za izdelke (EU) 2024/2853. Ugotavlja, da slovenski zakonodaji primanjkuje ključnih zaščitnih ukrepov, vključno z izrecno, sektorju specifično domnevo o vzročni zvezi in zakonsko pravico do dostopa do podatkov o varnosti zdravil, ter da ni predpisano obvezno zavarovanje. Nemška zakonodaja ponuja jasnejša pravila, postopkovno podporo in obvezno finančno kritje. Novosti direktive kažejo v smeri modela, ki je prijaznejši do tožnikov, kar Sloveniji ponuja priložnost za reformo"}],"edm:type":"TEXT","dc:type":[{"@xml:lang":"sl","#text":"znanstveno časopisje"},{"@xml:lang":"en","#text":"journals"},{"@rdf:resource":"http://www.wikidata.org/entity/Q361785"}]},"ore:Aggregation":{"@rdf:about":"http://www.dlib.si/?URN=URN:NBN:SI:DOC-TIVKPR1I","edm:aggregatedCHO":{"@rdf:resource":"URN:NBN:SI:DOC-TIVKPR1I"},"edm:isShownBy":{"@rdf:resource":"http://www.dlib.si/stream/URN:NBN:SI:DOC-TIVKPR1I/640824f4-7e4e-4d0a-a5fb-1e59aef53b0f/PDF"},"edm:rights":{"@rdf:resource":"http://creativecommons.org/licenses/by/4.0/"},"edm:provider":"Slovenian National E-content Aggregator","edm:intermediateProvider":{"@xml:lang":"en","#text":"National and University Library of Slovenia"},"edm:dataProvider":{"@xml:lang":"sl","#text":"Univerza v Mariboru, Pravna fakulteta"},"edm:object":{"@rdf:resource":"http://www.dlib.si/streamdb/URN:NBN:SI:DOC-TIVKPR1I/maxi/edm"},"edm:isShownAt":{"@rdf:resource":"http://www.dlib.si/details/URN:NBN:SI:DOC-TIVKPR1I"}}}}