"The judges reiterated that the doctor remains free to choose the drug to be used for the patient in science and conscience but they also underlined that the transition from the branded drug to the biosimilar is still possible, as also indicated by AIFA".
According to the Ordinance "the obligation to compile a report on the one hand cannot be considered, in itself, limiting the prescribing freedom of the doctor, who through this specific procedure will still be able to obtain the use of the drug he considers most appropriate to the case in point, on the other hand it cannot be considered a useless fulfillment even when the prescription refers to a patient "not naïve”, taking into account that even for patients of this type, according to the position paper of Aifa and the further scientific literature referred to in the appeal, there are cases in which the drug already used can or even must be replaced with another biosimilar (when the previous exposure to the drug is sufficiently distant in time and when from the use of the specific drug, inconveniences for the patient have emerged).
The Ordinance arises from the appeal, by a pharmaceutical company, of a Resolution of the Tuscany Region on the prescription of biological drugs.
Related news: Council of State ordinance n. 04516/2015
Press release Italian Biosimilars Group
AIFA. Position paper. Biosimilar drugs
Scaccabarozzi (Farmindustria): "Doctor must be able to act in science and conscience"
Active citizenship: "Doctors prescribe according to conscience and without limitations"
