Legal Aspects of Off-Label Treatment with “Medical Marijuana” in Terminally Ill Patients – a Medical Experiment or an Embodiment of the Patient’s Right to Receive Services in Accordance with Current Medical Knowledge?

Abstract

The subject of the use of medicinal products containing “medical marijuana” during the therapy of terminal patients has been the subject of extensive discussion until recently. Currently, such action is legal, but questions still arise not so much about the possibility of using medical marijuana in the treatment of terminally ill patients, but about the implementation of off-label use treatment. The analysis of the applicable legal provisions, views of scholars in the field, and the case law allow us to conclude that treatment involving medical marijuana inconsistently with the SmPC (Summary of Product Characteristics) is an acceptable action that should not be equated with a therapeutic experiment in the strict sense. The above is confirmed by the admissibility of using marijuana raw materials as the basis for the preparation of a pharmacy-compounded (prescription) medicine. The production of pharmacy-compounded drugs requires the use of pharmaceutical raw materials, the amount and composition of which depend on an independent decision of the person prescribing the medicine. The admissibility of any composition of the contents of a pharmacy-compounded drug containing medical marijuana speaks for the admissibility of its use in any way. The above leads to adoption of similar requirements in relation to pre-made drugs containing marijuana. Regardless of the admissibility of using medical marijuana outside the SmPC or in the form of a compounded drug, medical marijuana treatment is the implementation of the patient’s right to treat pain and receive health services in accordance with the current state of medical knowledge.

Keywords

• medical marijuana
• off-label drug use
• marijuana pain management
• patient’s right to treat pain