The renegotiation of the amounts of public contracts, provided for by the law decree n. 66/2014, in the advantage of the P.A., doesn’t constitute the exercise of an authoritative public power, but rather a potestative right in an equal contractual relationship; therefore, every dispute on this matter is devolded to the Ordinary Judicial Authority (T.A.R. Toscana, Sez. I, decision 29th june 2015 n. 977).
The new decree of the Health Ministry that modifies the national Pharmacovigilance system has been published; among the main innovations introduced, we point out a new and wider definition of “adverse reaction”, and the obligation, for physicians and health workers, to signal every suspect adverse reaction, within 2 days (or 36 hours, for biological medicinal products).
The decree provides that the adverse reactions report can be filed also through the AIFA web portal, now in pilot scheme phase. By this portal, AIFA will publish all the notable information relevant to drugs’ safety. Furthermore, the Agency will be able to impose to the marketing authorisation holder binding conditions ensuring the safe use of the medicinal product, such as the conduct of clinical studies on efficacy and safety during the post-authorisation period (PASS), as well as inspections on the respect of the obligation, for regulatory authorities, to report adverse reactions (D.M. 30th april 2015, “Procedure operative e soluzioni tecniche per un’efficace azione di farmacovigilanza adottate ai sensi del comma 344 dell’articolo 1 della legge 24 dicembre 2012, n. 228”, published on the Offical Journal n. 143 of 23rd june 2015).