“The shelf procedure is based on incorrect data and has clearly undermined the correctness of the procedure itself. But they are data that the Agency receives and cannot modify”. The clarification from the Agency's Legal Affairs Office
November 19, 2015 – PharmaKronos
“Every year companies resort to the Tar, which proved them right for the first time, as they were able to demonstrate that the data from the Regions were sometimes wrong. The fact that the shelf procedure is based on incorrect data has clearly undermined the correctness of the procedure itself. But they are data that the Agency receives and cannot modify”.
This was explained by Francesca Mastroianni, director of the Legal Affairs Office of the Italian Medicines Agency (Aifa), in a hearing to the Social Affairs Commission of the Chamber, responding to an M5S resolution which refers to the 'rejection' by the Lazio Regional Administrative Court of the method used by AIFA to calculate the share of the overruns of hospital pharmaceutical expenditure (payback).
“There was a favorable pronouncement from the Tar – he elaborates – because it was said that companies must be able to know this data, but the Agency does not have them, it only has aggregate data. At that point, the Ministry of Health proceeded to provide disaggregated data. Now in the Salva Regioni decree, the Regions are allowed to budget the sums that were foreseen for the shelves of the past years, but now the Agency is required to redo the procedure and will restart it with all the transparent data, enabling companies to control them ".
"The dispute - also intervened the Dg Luca Pani - derives from an appeal not on AIFA calculations, but on data from the Regions, which undermined the entire procedure".
Barbara DiChiara
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Related news:
M5S. – Pay Backs (Judgment n. 04538/2015 Tar Lazio - Judgment n. 3977/2015 Council of State)
In addition to what has been described, the continuous defeats suffered by AIFA before the Lazio TAR and the Council of State, regarding the so-called payback on hospital pharmaceuticals, must be remembered. A capital quantifiable at around one billion euros which still does not find its rightful place in the coffers of the Regions with serious repercussions on the budgets of the various entities.
We want to remind you that theAifa is a public body and therefore it cannot act with the discretion and lack of transparency that I have just described. Why are the Ministry of Health and the Ministry of Economy and Finance, which have supervisory tasks over the Agency, not intervening?
In the light of what has been reported in detail, we hope that we will soon be able to talk about the decisions of the former AIFA director, because we believe there is a lot to say.
Related news: Lazio Regional Administrative Court. Judgment No. 04538/2015 REG.PROV.COLL. N. 05394/2013 REG.RIC
