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Abstract

Decision C-29/17, Novartis Farma, of November 21st, 2018, of the Court of Justice of the European Union concerns the compatibility with EU law of national rules on off-label drugs prescription. The case deals with the off-label use of a product which proved to be effective for the treatment of ophthalmological diseases, whereas the recommended medicine is much more expensive for the national healthcare service. The Court confirms that national rules are compatible with the EU legal framework if necessary safeguards are respected. The aim of the commentary is to underline the possible implications of this ruling, at a EU level and for single member States.

Key-words: Drugs; Off-label pharmaceuticals; Right to healthcare; Resource allocation; Competition

Sommario: 1. Introduzione: il costo dei farmaci quale paradigma dei nodi di sostenibilità dei sistemi sanitari – 2. L’intricata vicenda Avastin-Lucentis: dall’autorizzazione all’immissione in commercio alla Corte di Giustizia – 3. La portata innovativa della sentenza, tra dimensione interna e scelte allocative in campo sanitario – 3.1. Oltre l’equivalenza: la sostenibilità finanziaria del sistema – 3.2. Il necessario rapporto tra valide alternative terapeutiche e criteri economici – 4. Considerazioni conclusive: la rilevanza della sentenza in prospettiva comparata