Beyond Aifa. What is the government doing for a strategic industry? Nothing
Il Foglio - July 5, 2023 by Redazione
Six months after its approval in Parliament, the Aifa reform continues to exist only on paper. Why then hastily approve the reform of the Regulatory Agency by way of an amendment to the 
decree to strengthen NATO and NHS Calabria and then continuously postpone its implementation? It was no longer reasonable to study an ad hoc measure and involve industry experts with a cycle of hearings given that we are talking about an agency called to manage 32.2 billion in pharmaceutical spending and to supervise the marketing authorization of new drugs?
Aifa it is a strategic body, essential for guaranteeing access to innovative therapies, central to independent research and fundamental for the competitiveness of the entire drug supply chain in Italy. With the new governance centralized in the hands of the president of the board, of totally political origin, its characteristic of scientific independence is distorted.
With the Entities decree, the terms of the term of office of the members of the Technical-Scientific Advisory Commission (CTS) and of the Pricing and Reimbursement Committee (CPR) were extended again to 1 October 2023.
Time is therefore being taken up again pending the implementation of the reform which envisages the merger of the CTS and CPR into the Scientific and Economic Commission (CSE) with the aim of streamlining the procedures and speeding up the evaluation process. However, by halving the number of current commission members, going from 20 for the CTS and CPR to 10 for the new CSE, there is a risk of losing specialization, thus having to resort to more external opinions which, needing time, risk canceling the presumed advantage of speeding up the process evaluative.
The impression is that of a reform patched up due to a haste as incomprehensible as it is unjustified. Who knows if Farmindustria, tomorrow, when many government ministers meet at its assembly, will have the strength to show the executive what it is doing for Italian pharmaceuticals: zero.
Bota: Draft of the Regulation
