By its judgment no. 1026 filed on 2 March 2015, the Council of State upheld the action by which Federfarma challenged two determinations of the Italian Medicines Agency (Agenzia Italiana del Farmaco). The Agency ordered the inclusion of the medicine Forsteo in the PH-T regime, with the result that it was no longer marketable by pharmacies generally and could only be dispensed by hospitals (so-called “direct distribution”) or by a limited number of pharmacies through specific agreements with the Regions (so-called “distribution for account”).
The administrative court ruled that the classification of a medicine as PH-T can also be motivated by spending needs, but health considerations must prevail. According to the Council of State, such reasons can not be explained by the "need for Hospital-Territory continuity", but must be based on medical health considerations that take into account, the procedure followed in order to affirm the need for separate administration at hospitals.