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Off-Label Use Reimbursement: A Review of the Status Quo in the Context of the Recent Novartis/AIFA Case

Peter von Czettritz, Alexander Meier


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.

Peter von Czettritz and Alexander Meier are both attorneys at law and Partners in the Law Firm Preu Bohlig & Partners, Munich (Germany). For Correspondence: <> and <>


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