In brief

With Decision No. 131, published on 4 January 2023, the Council of State ruled on the possibility for pharmaceutical companies to know in advance the data used by the Italian Medicines Agency (AIFA) for the calculation of the pharmaceutical payback. 

Key takeaways 

In the context of the relevant proceeding, the appellant claimed that the failure to share such data would make the quantification of the payback unreliable, since the error made in the calculations regarding one company would necessarily affect the correctness of the calculations concerning the other companies.

In this regard, the Council of State stated that there is no prior and general communication obligation of the data used by AIFA to establish the pharmaceutical payback. Indeed, according to the Council of State, the possible communication of such data can occur at a later stage, through the exercise of the right of access to documents or, in court, through the procedure provided for by Article 116 of the Administrative Procedure Code.