Report

The Relevance of the Orphan Drug-Regulation in German AMNOG for Patient Care

vfa

The latest report by Simon-Kucher carried out on behalf of the German Association of Research-Based Pharmaceutical Companies (vfa) illustrates how the abolition of the Orphan Drug-Regulation in the German market could jeopardize the care of patients with rare diseases based on a retrospective market simulation.

The retrospective analysis shows that more than half of the Orphan Drugs would be exposed to a very high to maximum risk of market withdrawal in the event of a hypothetical abolition of this regulation. The abolition or restriction of the Orphan Drug-Regulation would therefore not be feasible without far-reaching negative consequences for patient care with Orphan Drugs in Germany.

 

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