To gain access to the Italian market, a pharmaceutical company must be prepared to give payers a money-back guarantee. These “risk-sharing” agreements between central and regional payers and manufacturers are becoming more common in Italy, forcing companies to prove the value proposition of their products or risk not getting paid.
In Italy, pharmaceutical regulation is governed by The Italian Medicines Agency (AIFA), and members of the Italian Association of the Pharmaceutical Industries abide by the Code of Professional Conduct. Promotion of prescription-only medicines is not permitted, and promotional material includes any scientific information provided by pharmaceutical companies directly to consumers.
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