Funds for active pharmacovigilance. Three tranches for financing
Adverse reaction studies, evaluation of drug use, independent information and training, strengthening of the pharmacovigilance of the Ethics Committees. These are the topics on which active pharmacovigilance projects can be articulated for which AIFA will be able to stipulate special agreements, both with a single administration and with a group of which a Region is the leader. And for these agreements, the Ministry of Health has proposed to the governors the allocation of the 25 million allocated by law (449/1997 and 296/2006). Of the sum, 23.750 million will go to the Regions for the agreements and 1.250 to AIFA for all the fulfillments envisaged by the programme, including the periodic transmission to each Region of the expenditure/consumption data provided by Osmed, the expenditure data to the various Regions through the Aifa-Sfera Project, the periodic transmission to each Region of the data on clinical trials provided by the Ossc and that of the data relating to the meetings and congresses organized and sponsored by the pharmaceutical companies aceutics etc. For a rapid disbursement of the funds, a first tranche, equal to 30% of the fund, will be assigned immediately, on a per capita basis, for the continuation of initiatives already underway and/or anticipation of the programs that will form part of the agreements with Aifa; a portion of the 60% will be disbursed following the stipulation of the agreement agreed with Aifa and a portion (the 10%) will be used for national or multi-regional projects and the Regions that adhere to individual projects will be financed for the portion referring to their Region. The assignment proposal Advance payment 30% Region ( € ) % Regions Total sum of individual Regions ( € ) 7.75 Piedmont 1,840,625.00 552,187.50 0.21 V. d'Aosta 49,875.00 14,962.50 15.62 Lombardy 3,709,750.00 1,112 925.00 0.76 Pa Bolzano 180,500.00 54,150.00 0.81 Pa Trento 192,375.00 57,712.50 7.74 Veneto 1,838,250.00 551,475.00 2.19 Friuli VG 520,125.00 156,037.50 3.18 Liguria 755,250.00 226,575.00 7.25 Emilia R. 1,721,875.00 516,562.50 6.44 Tuscany 1,529,500.00 458,850.00 1.51 Umbria 358,625.00 107,587.50 2.58 Marche 612,750.00 183,825.00 8.95 Lazio 2,125,625.00 637,687.50 2.24 Abruzzo 532,000.00 159,600.00 0.59 Molise 140,125.00 42,037.50 9.55 Campania 2,268. 125.00 680,437.50 6.73 Puglia 1,598,375.00 479,512.50 1.04 Basilicata 247,000.00 74,100.00 3.48 Calabria 826,500.00 247,950.00 8.60 Sicily 2,042,500.00 612,750.00 2.78 Sardinia 660,250.00 198,075.00 100.00 Total 23,750,000.00 7,125,000.00 60% to be attributed to the signing of the agreement (14,250,000.00 €); 10% balance as per contract (€ 2,375,000.00); sums destined for Aifa (5%) (1,250,000.00 € ) Il Sole 24 Ore Sanita' of 11/15/2007 N. 44 13-19 NOVEMBER 2007 p. 15
