Farmaci off-label ed equilibrio interno dei sistemi sanitari: la parola della Corte di Giustizia

Off-label drugs and economic sustainability of healthcare systems: the point of view of the Court of Justice of the EU

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.