Early access according to Law 648: a review for the clinician

Abstract

Law 648 has been introduced in Italy in 1996. It allows early access and off label use of novel drugs that fulfill important unmet medical needs. Despite being live for almost twenty years, there are still several areas where the clinician does not have sufficient confidence for a proper use of the opportunities created by Law 648. In this review we describe the main points that a clinician should be aware of when demanding permission to use new drugs according to law 648. Roles and responsibilities of the prescribing centers and the individual physicians are illustrated and discussed in a Q&A format that clarifies some of the more complex scenarios that a physician may face in the use of Law 648. This should help the clinicians in fostering a proper use of this important pathway for early access of novel, innovative drugs in Italy.

Keywords

• Informed consent
• Early access
• Law 648
• Off-label