Off-Label Use Reimbursement: A Review of the Status Quo in the Context of the Recent Novartis/AIFA Case journal article Peter von Czettritz, Alexander Meier European Pharmaceutical Law Review, Volume 3 (2019), Issue 2, Page 73 - 81 The reimbursement of authorised medicinal products for indications and uses outside of their authorised label – so-called “off-label use” – has become a hot topic in the EU. The recent judgment of the Court of Justice of the European Union (CJEU) of 21 November 2018 in the case C-29/17 addresses important crucial points for national reimbursement regimes. This article provides a critical review of this CJEU decision. In addition, the authors stipulate that Article 5(1) of Directive 2001/83/EC sets the frame for national reimbursement decisions according to which the off-label use of authorised medicinal products is limited to situations of 'special needs', as this would otherwise undermine the marketing authorisation (MA) system and render it ineffective.
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