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Ims Health, in Italy patents act as a 'shield' for deficiencies

"In our country we have not had the opportunity to encounter phenomena of systematic and important shortage of drugs, as happens instead in the United States, where the phenomenon is particularly evident in the generic sector, many of which are injection formulations, used in specialist fields. We believe that this is due to some relevant structural differences between Italy and the USA".

Sergio Liberatore explains it to Pharmakronos [in the picture], chief executive officer of Ims Health, a company specializing in marketing information for the pharmaceutical industry. Compared to what recently published by the Ims Institute for Healthcare Informatics in relation to the shortage of drugs in the United States, the situation in Italy is therefore very different: "First of all - Liberatore points out - the US system applies many incentive levers to the substitution of the drug expired originator with the equivalent, both in pharmacies and in hospitals; consider that the replacement rate in many States exceeds 90% and in some cases, such as in hospital programs for the most indigent groups, it is even mandatory, or replaced by a system of specific discounts and defined by law.

In Italy, on the other hand, there is a drug protection system that leads to more delayed patent deadlines".  "Even if the situation will change in the next 3-5 years - adds Liberatore - today most of the specialist products still enjoy patents and this represents a first reason for the reduced shortage of drugs in our market compared to what happens overseas". A second point of difference concerns "the welfare system - continues the expert - which in the United States provides for private insurance companies with lists of admitted positive drugs, drugs that are often the cheapest/generic.

In Italy, however, the phenomenon of private assistance is very limited and therefore there is no forced therapeutic choice towards outdated molecules at risk of unavailability. Furthermore, since in our country the reference price on expired patent products only applies if there is a similar generic package, in the frequent cases in which injection formulations are not registered as equivalent, the price does not vary and there are no reasons for reducing the margin that justify a production slowdown. Even in sporadic cases of momentary production blocks linked to contingent phenomena, such as machine downtime, it is difficult to highlight significant deficiencies in the supply chain, since the demand generated locally has smaller volumes", concludes Liberatore.

December 7, 2011 – PharmaKronos

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