Schutz vor gefälschten Humanarzneimitteln im Binnenmarktrecht

Falsified medicines are a current and worldwide problem, which is growing in urgency within the EU due to their high incidence. This work analyses the present protective measures against falsified human medicines in single market law. The study narrows down the topic by defining falsified medicines and then by demonstrating the subject’s relevance through its background and effects. Applying the duty of protection theory, the work examines whether the EU and its member states have an obligation to protect against counterfeit medication. The criteria developed serve to evaluate the protective measures identified in EU law and in the laws of four representative member states (Germany, England, Italy and Hungary). Finally, considering the central position of the European safety features within the protection system of single market law, the study considers their design and lawfulness in more detail.