Law 326/2003 established a national fund financed by 5% of the pharmaceutical companies' annual expenditure on promotion activities.
The 50% of the resources of this fund is used for the use, at the expense of the National Health Service, of orphan drugs for the treatment of rare diseases and drugs that represent a hope of therapy, pending commercialisation, for particular and serious diseases.

• Drugs that are not yet on the market are eligible, provided that phase II or III clinical studies have been published with a favourable evaluation in terms of efficacy and safety.
• Physicians require the use of the drug on a nominal, per-patient basis.
• The purchase is supported by the hospital and if the request is evaluated positively, it is reimbursed by AIFA through the fund.

Below is an outline of the steps by which a hospital can apply for access to the fund.