Access to the registration dossier of a medicinal product – commentary on the judgment of the Supreme Administrative Court in Warsaw of 23 February 2022, III OSK 1691/21

Abstract

This approving commentary concerns the judgment of the Supreme Administrative Court in Warsaw (SAC) relating to access to the registration dossier of a medicinal product. In this judgment, the SAC innovatively applied the concept of Bernatzik’s triad to the assessment of Article 34 of the Pharmaceutical Law, which, in its literal wording, restricts access to such documentation exclusively to entities with a relevant legal interest. In its analysis, the SAC drew upon this concept and the relevant context of EU law, thereby facilitating a comprehensive breakdown of the provision’s literal meaning. This analysis determined that the principles derived from the Access to Public Information Act should be applied. The authors concur with the SAC’s ruling and the direction of the argumentation. However, they draw attention to specific elements omitted in the ruling and provide a more detailed argument for the necessity of public access to parts of the registration dossier through a full pro-EU and pro-constitutional interpretation.