A validade do consentimento informado na prescrição off label: uma perspectiva jurisprudencial

Abstract

This work is a study on the validity of informed consent in medical practice, especially in cases involving off-label prescriptions. Thus, the central discussion revolves around the lack of specific regulation regarding these prescriptions, creating legal uncertainty for both physicians and patients. This ethical and legal complexity highlights the need to reflect on the limits of physicians' therapeutic freedom and the importance of the duty to adequately inform patients about potential risks and consequences. The research demonstrates that informed consent, more than a bureaucratic formality, constitutes a fundamental ethical and legal guarantee, serving as an instrument to protect patient dignity and autonomy. The analysis of national case law highlights a strong tendency to value patient autonomy, recognizing that the absence or so-called "blanket consent" of informed consent constitutes, in itself, unlawful conduct because it lacks voluntary and conscious consent, and is subject to civil liability, even when there is no technical error. Given the scientific uncertainty inherent in off-label prescriptions, the study concludes that free and informed consent plays a crucial role in individual self-determination. Consequently, if a patient's rights are violated, the physician will be held civilly liable for failure to inform. Therefore, it is essential that communication between the physician and patient be clear and specific and individualized, ensuring that the patient understands the risks involved. This ensures not only the legal certainty of medical conduct but, above all, respect for the patient's dignity and self-determination