Off-label use of medicinal products ñ legal rules and practices

Abstract

The off-label use of medicinal products raises many interpretation-related issues, not only among physicians but also pharmacists and lawyers. The use of drugs in a manner other than that specified in the Summary of Product Characteristics is not regulated by Polish law. The authorsí goal is to discuss the topic mainly from the practical perspective, while also considering its theoretical aspects, and to identify systemic solutions to several problems, that are extremely important for the proper functioning of the entire healthcare system. The paper highlights that there is a fine line between experimental medicinal practices and those that are in keeping with current medical knowledge.