The 5% Fund is a national fund set up by Law no. 326 of 2003 in which companies are required to donate 5% of their promotional expenditure to an independent research fund. Orphan drugs for serious diseases or which have promising therapeutic value can have access to the AIFA 5% Fund (Fondo AIFA 5%) before they are marketed in Italy.
Companies must provide AIFA with the self-certification by 30 April 2018 of the total amount of expenditure incurred during 2017 for promotional activities, net of expenses for employees, on the approved scheme based on Decree of the Minister of Health.
The application form must be sent to the following address firstname.lastname@example.org indicating in the subject the reason “Self-certification 5%” and the name of the pharmaceutical company.