Abstract
In the Novartis Farma SpA case (Case C-29/17), the Court of Justice of the European Union (CJEU) held that the decision of a Member State (Italy) to reimburse a drug used off-label (Avastin), and for that purpose submitted to repacking procedures, is not in violation of European law, even if there is a duly approved therapeutic alternative (Lucentis) on the market and the procedure is solely to reduce health care expenditures. This was not the CJEU’s first ruling on off-label drug use. The novelty of the Novartis Farma SpA case is the economic element attached to the assessment of off-label prescriptions, even though the Court failed to consider this essential feature of the case. This paper analyses the Court’s ruling in light of two main principles of European pharmaceutical law: the imposition of marketing authorization for drugs used in the European market; and the predominance of public health concerns over economic considerations. The paper concludes that the Court failed to identify a major issue in the Italian policy – the reimbursement of off-label drug used when there is a properly approved therapeutic alternative on the market – at the risk of undermining the entire European pharmaceutical framework and endangering public health.
Published Version
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