The problem of using the summary of product characteristics for a purpose different than marketing authorization

Abstract

A successfully completed registration process of a medicament is associated with being granted national marketing authorization together with having the summary of product characteristics (SPC) approved. The article addresses problems that occur with the use of the SPC for purposes other than originally assumed, the marketing authorization of medicaments. Pharmaceutical companies wishing to register a new medicinal product are not required to provide all possible uses of the drug in the SPC, or to update the information contained therein. Meanwhile, the physician is required to exercise the profession as indicated by current medical knowledge. The concept of indications of current medical knowledge should be considered to be broader than the indications contained is the SPC, and the doctor should decide on the treatment outside of the registered indications, but in accordance with medical knowledge flowing from scientific sources. How to identify problems resulting from differences between the SPC indications and current medical knowledge? Firstly, what is SPC and how is it created? Who is bound by it, and under what circumstances? What is the relationship between the Polish drug reimbursement system and the SPC? What risks come from the reimbursement list being built based on that document? What are off-label drugs and what is the source of their phenomenon? How is physicians’ liability shaped in connection with the SPC?