Off-label use of medicinal products in oncology: exercising due diligence or experimental activity?

Abstract

One of the primary responsibilities of a physician is to diagnose and treat diseases with due diligence. Exercising due diligence in treatment process involves, among others, the use of optimal diagnostic, therapeutic and follow-up management in accordance with the current state of medical knowledge. Each medicinal product has the Summary of Product Characteristics which defines, among others, registered indications, the age group for which the product is registered, the dosing scheme, and route of administration of the product. Polish law does not refer directly to the admissibility of products that use off-label nor does it include regulations forbidding such activities. Considering a number of problems associated with products which use off-label and, on the other hand, commonness of such activities, it is necessary to introduce legal regulations defining the legitimacy and admissibility of such methods of proceeding.