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Farmindustria: too much time to approve drugs

On average, in Italy the time to have access to medicines, even innovative ones, "are considerably longer, because in addition to national approval we have the approval of regional formularies which undoubtedly extend the times compared to other countries". This was stated by the president of Farmindustria, Massimo Scaccabarozzi, on the sidelines of a conference on the new frontiers of market access. «From a survey recently carried out» adds Scaccabarozzi «it emerged, in fact, that to be included in all Regions, the times, albeit with regional differences, are on average 200-230 days from publication in the Official Gazette by the Italian Medicines Agency». And he adds: «It is true that the Ministry of Health has recently ordered that products for which innovativeness is recognized at a central level must be immediately made available at a regional level but we have not yet seen the implementation of this bill. When it is fully applied, we will probably have reached an important milestone for Italian patients who will no longer have discrimination". As for the role of market access, Sacccabarozzi added, "the problem does not only concern innovative products but all products, even those already on the market, because it is not said that they have access to the market for the entire life of the product". According to the president of Farmindustria, in fact, "situations can arise such that in the life cycle of the product some products, due to decisions taken at a regional level, can have different accesses in one region rather than another". Therefore, he concludes, "it is very important that there are specialized figures who are able to fully understand how to work to ensure that Italian patients are granted access to therapies, not just innovative ones".

Pharmacist33 – 27 October 2011

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