Payback 2013, also the appeal of Federfarma accepted by the Lazio Regional Administrative Court

Fedaisf editorial staff

January 14, 2016

In the provision of the Agency "there is no indication that makes it clear how AIFA has come to the concrete determination of the quotas (of payback, ed) to be attributed to pharmaceutical companies, pharmacists and wholesalers"

14/01/2016 – Federfarma

The shelf of pharmaceutical expenditure in 2013 gets the third rejection in less than a year from the Lazio Tar. The most important for the pharmacies of the area, because the appeal presented a little over a year ago by Federfarma is passed, accepted the day before yesterday by judges such as those of industries And wholesalers. Once again in the crosshairs, the resolution of October 2014 with which AIFA dictated the methods of the "payback" for the breakthrough of the previous year. Illegitimate determination, writes the Tar in the sentence filed the day before yesterday, because the application of the rules on the shelf "does not seem to respond to what they establish".

In its appeal, in particular, Federfarma had noted that in the Agency's provision "there is no indication that makes it possible to understand how AIFA has come to the concrete determination of the quotas (of payback, ed) to be attributed to pharmaceutical companies, pharmacists and wholesalers". There is therefore no possibility of ascertaining what assessment has been made on the expenditure for direct distribution/dpc, which contributes to the breakthrough of the territorial pharmaceuticals but must be attributed to the Regions or Local Health Authorities because the pharmacies ensure "the mere dispensing" of the drugs, " against a professional fee often defined as a fixed amount". Nor is it clear, the appeal continues, whether in the subdivision of the breakthrough between the operators of the supply chain each for their own share,77/2009, which introduced a flexible margin on generics (up to 8% of the retail price) for "free negotiation" between distributors and pharmacies.

La sentenza del Tar fa proprie le perplessità di Federfarma e ripropone le considerazioni già espresse dal Tribunale davanti al ricorso degli industriali: per il ripiano del 2013, l’Aifa si è basata soltanto su «un dato aggregato a livello nazionale» che «non consente in alcun modo di verificare l’esattezza complessiva» dei calcoli. Ne deriva dunque una metodologia che appare «in palese contrasto con il principio di trasparenza dell’azione amministrativa e con il principio che spetta all’amministrazione provare la fondatezza e la veridicità dei fatti sulla cui base ha adottato uno determinato provvedimento».

Over the next few days, Federfarma will evaluate the sentence in detail with its legal advisors. The associated pharmacies will be promptly informed of the decisions that will be taken regarding the recovery of the payback, paid for a six-month period through an increase of one tenth of a point on the 0.64% discount. (AS)