Italian Medicines Agency Agenzia Italiana del Farmaco

Pharmaceutical Expenditure: TAR Lazio rejects the appeals by Pharmaceutical Companies on Payback 2019 - Pharmaceutical Expenditure: TAR Lazio rejects the appeals by Pharmaceutical Companies on Payback 2019

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Pharmaceutical Expenditure: TAR Lazio rejects the appeals by Pharmaceutical Companies on Payback 2019

Press release no. 677 - AIFA welcomes and announces the recent judgments whereby the TAR (Regional administrative court) Lazio rejected the appeals lodged by some pharmaceutical companies against the procedure for calculating the pharmaceutical payback adopted by AIFA for 2019 and the definition of the related shares (judgments no. 12750/2021; 12757/2021; 12763/2021; 12771/2021).

The judgments, in clear discontinuity with those relating to the proceedings for the years 2013-2017, affirmed the correctness of the complex calculation procedure carried out by AIFA and the firm compliance with the principles of good administration, efficacy and cost-effectiveness of the administrative action. Therefore, the complaints were rejected of insufficient participation in the proceedings as well as the appellants’ requests for a sort of “co-management” of pharmaceutical expenditure together with the Agency. The legitimacy was also recognized of the confidentiality maintained by AIFA regarding the sales data of the various pharmaceutical companies.

The aforementioned judgments therefore acknowledge AIFA’s proper operation, as well as the efforts made to ensure transparent participation in the administrative procedure of each individual pharmaceutical company, so finding a balance with the protection of general interest.

In this way, AIFA complies with its institutional mandate, favoring the full recovery of payback costs for direct purchases borne by National Health Service (SSN) facilities, which in 2019 amounted to over 1.36 billion EUR.

These are important resources for the Regions and the Public Administration to ensure optimal and geographically homogeneous delivery of pharmaceutical assistance for the benefit of all citizens and patients.


Published on: 17 December 2021

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