The company budget is done like this
Parity on incremental resources – Additional pro-innovation fund
Compliance with the expenditure ceiling for territorial, national and regional pharmaceuticals; uniformity of allocation of incremental resources allocated in the company budget, both for patent medicines and for generics; immediate identification of the values attributable to the additional fund for spending on innovative training and to the guarantee fund for the allocation needs of the market. These are the three key criteria for drafting the application methodology of the pharmaceutical sector reform launched with the fiscal link to the 2008 Budget Law (Article 5, Law No. 222 of 29 November 2007). The regulation establishes a ceiling of the 14% for local pharmaceuticals, including both the agreed expenditure, gross of the ticket, and the direct distribution paid by the NHS: any overflow is distributed over the supply chain net of VAT on the basis of duty on medicines. For pharmaceutical companies, the amount of the shelf - dry and direct payback in the regional coffers - is calculated on the budget assigned to each company by applying the first Italian model of the portfolio method, of which the technical document - which we publish in its entirety - illustrates the mechanisms and methods . (SJod.)
The incremental resources assigned, on an annual basis, to the territorial pharmaceutical expenditure are defined by the following procedure: a) calculation of the difference between the maximum value of the NHS charge for the territorial pharmaceutical expenditure planned in the year compared to the value of the previous year. For the year 2008, the amount of expenditure ", the breakdown between the various Regions are taken from the decree of 20 December 2007, published in the Official Gazette no. 2 of 3/1/2008. Any changes in expenditure subsequent to the aforementioned decree will be considered * derated in the phases of expenditure monitoring and final accounting envisaged by the law.According to the data of CIPE resolution No. 97 of 28/9/2007, the charge for territorial pharmaceutical expenditure for the year 2007 is equal to 13,373 euros. 218,600, equivalent to 14% of NHS resources net of the sums disbursed for the financing of activities not recounted by the healthcare companies (95,522,990,000 euros)' (after hearing from the Mef - CIPE resolution); b) calculation of the difference between the expenditure attributed to the molecules patent expiring during the year and the corresponding expenditure estimated on the basis of the price reduction applied to the relative generic-equivalent medicinal product. For generic-equivalent medicinal products whose prices have already been defined in the negotiations, the lower expenditure is calculated by applying the prices negotiations; for generic-equivalent medicines whose price has not yet been negotiated, an average price reduction of 40 percent is applied. The calculation of the lower expenditure for generic-equivalents takes into account the actual period of the year in which patent • coverage is absent and consumption in the corresponding periods relating to the previous year (e.g. for a molecule whose patent expires at 30/3/2008, 3/12 of spending for the year » 2007 are attributed with the current price and 9/12 at the reduced price). The difference on an annual basis constitutes the part of the incremental resources deriving from generic-equivalent medicines (point b). For 2008, the incremental resources available as a result of patent expiries are calculated at €518,286,722. In the initial application phase and subject to final adjustments, the effective entity of the incremental resources allocated on an annual basis takes into account the estimate of any difference between the territorial pharmaceutical expenditure for the year 2007 • and the 14% ceiling set by the referred to in letter a) of the calculation
