Expanded access according to Ministerial Decree of 8 May 2003 could be sought if "there were no valid therapeutic alternative for the treatment of serious diseases, or rare diseases, or pathological conditions that put the life of the patient at risk".

It was furthermore required that clinical trials were on-going (phase III) or have been concluded (phase II or III).

The request could be submitted by a physician or group of physicians when no therapeutic alternatives existed for treating patients suffering from serious or life threatening diseases, or orphan diseases.

In practice, the request could have been submitted either (i) for the treatment of a named patient; (ii) for the treatment of a group of patients; or (iii) for the treatment of patients who had benefited from a trial since terminated in order to ensure continued therapy.