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Assogenerics. Payback: Protect all pharmaceutical SMEs

“We salute the reform of the payback system, introduced with the budget law which, after many years of reflection, meets the protection needs of pharmaceutical SMEs. With this choice, the Government has listened to the request for greater equity from our sector; in fact, we had expressed our concerns about the possibility of eliminating the safeguard clauses envisaged by the legislation in force on the participation in the shelf by equivalents and biosimilars to the breakthrough of innovative drugs and orphan drugs ", this was stated by Enrique Häusermann, president of Assogenerici, in relation to the text of the 2019 Maneuver approved during the night with a vote of confidence by the Palazzo Assembly Madame.

"The exclusion of companies in our sector from the extra-roof shelf of innovative drugs and the introduction of a "deductible" that protects SMEs with a turnover of less than 3 million euros demonstrates the willingness to listen and dialogue on the part of the Government - continues Häusermann - even if we have to note the persistence of criticalities on the overrun deriving from the purchase of orphan drugs from the Community register which do not have dedicated resources and whose extra-spending would in any case continue to weigh on the entire sector. It would be necessary to open a serious debate on alternative forms of financing for this category of drugs with a high social impact, recovering, for example, the request made by all companies to allocate all the resources available within the spending ceilings to cover new needs".

"We hope that the constructive dialogue will also continue during the implementation of the measures hypothesized in the Health document on the new pharmaceutical governance - concludes the president of Assogenenrici - hoping that a frank dialogue will be possible on this too which will allow a balanced consideration of the evolution of the various components of sector expenditure”.

Assogenerici – 23 December 2018

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