Legal aspects of off-label drug use in palliative care in Poland

The Summary of Product Characteristics contains information on the optimal use of a medication, which allows for achieving the best therapeutic effect and guaranteed patient safety. That document defines the action of lege artis. A physician is not, in general, responsible for the adverse effects of a particular medication on the patient’s health when following these guidelines. Deviations from them may be qualified as a so-called medical error and lead to multifaceted legal liability. However, the indications contained in the Summary of Product Characteristics are abstract and do not necessarily have to be case-specific. Sometimes proper therapeutic management even requires a derogation from these directives. Therefore, the article discusses the legal constructions that are applicable in this respect. From the perspective of criminal law, this issue should be considered through the prism of the so-called required precautionary rules. From the civil law perspective, so-called due diligence should be taken into account. Compliance with these rules excludes liability. The study approximates these constructions and discusses them, taking into account the medical law regulations that entitle a physician to choose the method of treatment. Apart from these requirements, the sine qua non of the legality of off-label therapy is to obtain legally valid consent from the patient. The article presents its premises in terms of the scope of the information obligation and other conditions of informed consent, which are important in the case of off-label prescription of the drug.