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EU removes patent-Aic link. Assogenerics: it was an obstacle to generics

The European Union has just approved a directive that eliminates the link between the duration of the patent and the marketing authorization (MA) of the drug. A rule which, as he explains Giorgio Foresti, president of Assogenerici, "was designed mainly for Italy and a few other EU countries, where generic drugs continue to be hindered". Already last year, continues Foresti, "Italy suffered a European infringement procedure for a law that linked the expiry of the patent to the AIC" while "the regulatory agency (AIFA), responsible for the AIC, did not Nothing comes with the term of the patent. Only our country and a few others adopt a mechanism of this kind, which substantially delays the duration of the patent and postpones the arrival of the generic drug on the market". A standard that is fully endorsed by Silvio Garattini, director of the Mario Negri Institute in Milan who comments on the generic market in Italy: «We still lack real competition between generic products, which is necessary to lower prices. Furthermore, there is still too much distrust among doctors, due to the propaganda of multinationals who seek to discredit generic products, which erode the market and reduce the price of products with the invented name". What scenario, therefore, for the drug market in the next few years! 10 years? «The local market will tend to decrease - underlines Garattini - because there are not many new products. The hospital market, on the other hand, is on the rise and therefore needs to be carefully monitored".

December 21, 2012 – DoctorNews

 

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