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GENERICS PRESCRIBED IN HOSPITAL DOCTORS WANT CLARITY

Milan The government has used the conditional but the premises are all there. Health Undersecretary Ferruccio Fazio said he was in favor of experimenting with the prescription of medicines based on the active principle, upon discharge from hospital. This would pave the way even further for equivalent drugs in Italy, which are already declining: of the top twenty drugs by NHS expense, no less than eighteen will lose or have already lost patent coverage over the next seven years. Reliable figures also show that the growth rates of the generics market are such that if in 2006 the annual increase in volumes was 14.23 per cent, the expected increase in 2012 will be 18 per cent. The president of the Italian Society of General Medicine (Simg), Claudio Cricelli, also spoke on the subject at the recent conference of Assogenerici, the association of producers in the sector: «By 2015, family doctors will have only generic medicines available for assistance to their patients in the area. And already in 2012, considering the expiry of several patents, an important category of medicines, the prescription antihypertensives, will practically all be available in an equivalent version». Cricelli admitted that, despite these numbers, even today in Italy the diffusion of generics is seen as a marginal phenomenon, and he hoped that the debate would start from another perspective than just that of economic savings. Just Simg, at the hands of its manager for the drug area, Saffi Ettore Giustini, actually put some proposals on the merits in black and white, publishing them some time ago in the Bulletin of information on drugs published by Alfa. Among these proposals emerges the need to demonstrate "effective bioequivalence" which is "a central aspect for consolidating the use of generics, as well as clarity on the type of excipients used". Simg then invokes «transparent information and communication; for example on inspections by the Higher Institute of Health (LSS) and the Italian Medicines Agency regarding raw materials, pharmaceutical companies, finished products, bioequivalence studies and post-marketing controls». From the point of view of the general practitioner (here the discussion intertwines with Fazio's idea presented at the beginning), again according to Simg, "therapeutic continuity with the same branded drug and/or with the same equivalent prescribed in first choice is central". But that's not enough, to lift any shadow, Giustini asks for clarity on the different indications on the technical sheet relating to the same active ingredients. Generics and their penetration in Italy were also discussed at the recent Health Festival in Viareggio. At that meeting Antonio Gaudioso, deputy secretary of Cittadinanzattiva-Tribunal of patients' rights (Tdm) argued that "the savings that the NHS obtains from the use of generic drugs should be reinvested in health care, perhaps by rewarding excellence". The proposal is not new, but Gaudioso reinforces it: «the money – he says – should also be used to reward innovation and investments in the pharmaceutical field. Only in this way, in fact, the pathologies that have greater difficulty in treatment, will be able to have greater attention and better coverage".

Corriere Medico dated 01/11/2008 , article by STEFANO DI MARZIO N.23 THURSDAY 9 OCTOBER 2008 p. 4 

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