Pharmaceutical liability for unexpected adverse drug reactions : a comparative study of Slovenian and German law

english

2026

volume 19, issue 2

causation   comparative law   medicinal products   pharmaceutical liability   pharmacovigilance   product liability   tort law

Univerza v Mariboru, Pravna fakulteta
(Obvezni izvod spletne publikacije)

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.

23.10.2026