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Balduzzi decree. Farmindustria: "Strong critical issues, especially on the Handbook and off label"

According to the president of the drug companies' association, Massimo Scaccabarozzi, after the spending review which introduced prescription by active ingredient, the Balduzzi Decree has also further penalized the sector. "Exports, employment, research and investments at risk".

14 SEPT"While appreciating the Government's commitment to mitigating the harshness of the provision published today in the Gazzetta", Farmindustria expresses its "opposition" to the chosen method of emergency decree and highlights the permanence of "strongly critical" elements. "In particular - explains the president of Farmindustria, Massimo Scaccabarozzi - on the rule relating to the revision of the Formulary, already governed by the current provisions which entrust this task to the competence of the Italian Medicines Agency. And on the one on off labels which, although attenuated compared to the initial text, it extends the possibility of using medicines for unapproved indications even in cases where there is an authorized therapeutic alternative".

All of this, underlines Scaccabarozzi, "less than a month from the law that introduced the prescription with active ingredient, a measure that does not save the State a penny and instead strikes at the heart of the brand, which represents the founding value of a sector based on research.

Recognizing their role is essential to adequately support innovation, investment and exports of drug companies in Italy, which is the second largest producer in Europe. The brand is in fact a real element of production quality and an important sign of recognition and trust on the part of patients, especially the older ones". Too many penalties, therefore, in a very short time. This is why Farmindustria, "also to avoid the collapse of employment", he once again asks "forcibly the repeal of the rule on prescription with active ingredients, at no cost to the State". "After a few weeks and once again by decree - continues Scaccabarozzi -, the third in just six months, the Government intervenes in pharmaceutical matters by once again modifying the reference framework of the sector, which at an international level is rightly considered strategic, while in Italy it seems to be a mere cost factor".

All this "despite the fact that the pharmaceutical industry has contributed to the containment of the

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