Permissibility of the off-label use of a medicinal product in the context of a doctor’s liability – an attempt at clarification of the issue under the Polish law

Abstract

Practising the profession of a doctor involves high social recognition but also entails responsibility for the health and life of a patient. In this context, pharmacological treatment applied in compliance with the formal registration of a medicinal product does not raise any serious concerns. However, it is not always possible to administer a medicine in a way that corresponds to its official characteristics. Clinical practice shows that it is often necessary to administer a medicine outside the requirements specified in the summary of product characteristics. In such cases, a legal, ethical and typically medical problem arises. The aim of the study is to analyse the entire legal environment of the doctors’ use of medicines outside the summary of product characteristics. The discussion leads to the conclusion that medical personnel are fully authorised to administer a medicinal product outside its official characteristics. However, this may only take place if such a decision is based on current knowledge, the doctor’s individual experience and acting in the best interest of the patient, as well as proper diagnosis of his/her current therapeutic needs. The legal regulations in force in Poland are sufficient in that sphere to ensure the well-being of the patient and protect the interests of the doctor, although – it should be admitted – their wording is not unambiguous enough to prevent more or less serious doubts as to their interpretation. Hence the proposal for legal clarification of the situation related to the administration of a medicine off-label.