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Green light from the Aifa board of directors for the tender for the assignment of 100 million euros for pharmaceutical companies that operate permanently in Italy and that undertake to invest in the national territory in the production, research and development of the sector. Last Thursday's green light sanctions the transition to the operational phase of the investment program agreements to be implemented in the three-year period 2007-2009 bearing in mind one of the following objectives: the development of phase I and II clinical trials with the coordinating committee in Italy ( at least one Italian component); opening or upgrading production sites (including land, buildings, machinery); the opening or enhancement of R&D units; the acquisition of new staff units with permanent contracts, for production and research. Only investments relating to products under development, medicines already in possession of AIC or medicines not authorized in Italy and intended for export will be admitted: the amount of the incentives cannot exceed 10% of the economic commitment deriving from the planned investments. The agreements then signed between Aifa and pharmaceutical companies will last a maximum of 36 months, which can be extended by only 12 months for obvious reasons of force majeure. Three areas to experiment. The possibility of participation granted to companies is very wide: each one will be able to present investment plans for all three sectors (production sites, preclinical research, clinical trials); for each individual sector, each company may present plans relating to a single site or to multiple sites, located in the same municipality or in different municipalities. The timing provides that the electronic compilation of the forms must be completed by 31 March: the AIFA evaluation commission will have to conclude the examination and selection also making use of external experts and summoning the companies to a hearing - by 30 June. The merit ranking proposal, drawn up in descending order, will contain for each investment plan the score obtained and the amount of the related loan, which may be lower than the expected 10% ceiling. In the evaluation of the investment plans, both the indicators relating to previous research activities (2004-2006) and the eligible investments (until 2009) will come into play. Everything will pass through a precise evaluation grid: Œ the characteristics of the proposing company (balance sheet strength, number of researchers, investment amount, integration with the NHS, etc.) will be worth up to a maximum of 25 points; investments in production sites, in compliance with regulatory provisions at European level (qualified personnel, real increase in production, export quotas, value of production for the NHS) up to 75 points; Z investments in pre-clinical research (qualified personnel, innovation, promotion of start-ups and spin-offs) up to 75 points; investments in clinical trials (Phase I and II trials with the coordinating committee in Italy, orphan drugs, trials in fragile populations, gender equity, etc.) up to 75 points. The incentives will be disbursed in the form of a premium price, understood as recognition for investments in R&D and production sites: 60% of the sum will be assigned at the time the contract is signed and the remaining 40% at the conclusion of the contract. An ad hoc working group will be set up to verify compliance with the agreements and – once the work is completed – all the results, including patents, and the products obtained from the financed research will be the exclusive property of the company that developed them. (S.Tod.) Il Sole 24 Ore Sanita' of 04/12/2007 4-10 DECEMBER 2007 – N. 47 p. 3   

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Fedaiisf Federazione delle Associazioni Italiane degli Informatori Scientifici del Farmaco e del Parafarmaco