20.500.12556/DKUM-95073 Odškodninska odgovornost za nepričakovane neželene učinke zdravil: primerjava slovenske in nemške ureditve magistrsko delo Tortious liability for unexpected adverse drug reactions: a comparison of slovenian and german regulations Zdravila že od nekdaj spremljajo človeštvo kot nepogrešljiv del zdravljenja in ohranjanja zdravja. Namenjena so izboljšanju kakovosti življenja, vendar je njihova uporaba pogosto zaznamovana z napetostjo med koristmi in tveganji, saj lahko povzročijo nasprotno od pričakovane koristi, tj. neželene učinke. Zaradi tveganj se pojavlja potreba po učinkoviti ureditvi odškodninske odgovornosti, katere glavni cilj je zaščita uporabnikov zdravil, hkrati pa se ne sme zavirati razvoja in dostopnosti zdravil. Posebne pravne izzive povzročajo nepričakovani neželeni učinki, ki niso vnaprej znani uporabnikom in lahko v nekaterih primerih povzročijo resno škodo. V nalogi je obravnavana pravna ureditev odškodninske odgovornosti za neželene učinke zdravil, pri čemer se primerjalno analizirata slovensko in nemško pravo. Ugotovljeno je, da sta obe ureditvi zasnovani na objektivni odgovornosti, vendar med njima obstajajo pomembne razlike, tako na ravni materialnega kot tudi procesnega prava. V slovenskem pravu je področje sicer zakonsko urejeno, vendar ostaja pomanjkljivo razvito v praksi, kar oškodovancem otežuje položaj. Nemška ureditev je na drugi strani normativno bolj izdelana in dopolnjena z obsežno sodno prakso, ki oblikuje jasnejše standarde za presojo odgovornosti. Vprašanja, ki so obravnavana v nalogi so ključna, saj ne glede na strogo regulacijo, zaradi same narave zdravil in njihove široke uporabe prihaja do nastanka škode, čemur se je nemogoče popolnoma izogniti. Pregledna in jasna obravnava možnosti doseganja odškodnine, ki jo ima uporabnik pa je zanj zelo pomembna. Bistveno je tudi katera pravila za povrnitev škode se uporabijo v primerih nepričakovanih neželenih učinkov. Del naloge je osredotočen na nemško ureditev, ki je na področju zdravil zelo natančna in ureja mnoga vprašanja, ki v Sloveniji ostajajo neurejena. Posebej je izpostavljeno vprašanje vzročne zveze, ki v slovenski posebni (lex specialis) ureditvi za področje zdravil ni izrecno urejena, zato se rešuje s pomočjo splošnih pravil o objektivni odgovornosti. Nasprotno pa nemška pravna ureditev vključuje natančnejša pravila, ki v določenih primerih omogočajo domnevo vzročne zveze. Medicines have accompanied humanity since the earliest times as an indispensable part of treatment and the preservation of health. They are intended to improve quality of life, but their use is often marked by a tension between benefits and risks, as they can cause the opposite of the expected benefit, i.e. adverse reactions. Due to these risks, there arises a need for an effective regulation of liability for damages, the primary aim of which is the protection of medicine users, while at the same time not hindering the development and accessibility of medicine. Particular legal challenges are posed by unexpected adverse reactions, which are not known in advance to users and can, in some cases, cause serious harm. The master’s thesis addresses the legal regulation of liability for adverse drug reactions, with a comparative analysis of Slovenian and German law. It is concluded that both systems are based on strict liability, yet there are significant differences between them, both at the level of substantive and procedural law. In Slovenian law, the field is regulated by statute, but it remains underdeveloped in practice, which puts injured parties in a disadvantaged position. German regulation, on the other hand, is more normatively refined and complemented by extensive case law, which establishes clearer standards for assessing liability. The issues addressed in the master’s thesis are crucial, as damage occurs despite strict regulation, due to the very nature of medicines and their widespread use, which makes harm unavoidable. A transparent and clear discussion of the possibilities for obtaining compensation is therefore of great importance to the user. It is also essential to know which rules for compensation apply in cases of unexpected adverse reactions. Part of the thesis focuses on the German regulation, which is highly detailed in the pharmaceutical field and addresses many issues that remain unregulated in Slovenia. Particular attention is placed on the concept of causation, which in the Slovenian special (lex specialis) regulation for the pharmaceutical sector is not explicitly defined, and is therefore addressed through the general rules of strict liability. In contrast, the German legal framework includes more precise rules which allow for a presumption of causation in certain cases. farmakovigilanca odškodninska odgovornost klinično preskušanje producentska odgovornost varstvo potrošnikov pharmacovigilance tortious liability clinical trials product liability consumer protection true true false N. Brndušić Slovenski jezik Angleški jezik Magistrsko delo/naloga 2025-09-03 19:20:49 2025-10-02 11:50:43 2025-10-03 03:32:48 0000-00-00 00:00:00 2025 0 Maribor 0 Maribor 1 spletni vir (1 datoteka PDF (V, 71 str.)) 0000-00-00 NiDoloceno NiDoloceno NiDoloceno 0000-00-00 0000-00-00 0000-00-00 347.4/.5:61(043.3) 251468547 MAG_Brndusic_Nina_2025.pdf MAG_Brndusic_Nina_2025.pdf 1 E0480868AFA11DC60FC84B268CA4C3F5 be36e4a9d3f0626f31bf6e864daaa2040b01cdeacd90474cdb18299d8e7ed0ab 0042bd01-90c8-11f0-9526-00155d000105 https://dk.um.si/Dokument.php?lang=slv&id=198346 Pravna fakulteta 0 0 0