OFF LABEL DRUG PRESCRIPTION: A REVIEW OF THE MEDICAL CIVIL (IR) RESPONSIBILITY BENEATH THE INFORMED CONSENT

Abstract

The present study aims to reflect about the off label drug prescription and its medical civil (ir) responsibility beneath the informed consent aspects, with the 1988 Constitution of the Federative Republic of Brazil, the Civil Code and the Medical Code of Ethics as parameters of discussion. The off label prescription is the one carried out by doctors in unrelated conditions from the producer's recommendations mentioned at the label. During his professional activity, a doctor, conditioned by the good scientific knowledge, in risks assumed by him, may choose to opt for the treatment that better attends to the case’s particularities, using, moreover, the application of drugs by similarity. Accordingly, the understanding of this matter goes through different legal and ethical aspects, such as the fundamental right of health, the medical therapy liberty, the right of information and the preservation of self-determination on behalf of personal physical and moral integrity. As an issue to be solved in this article, there is the facing of the elements that shape the medical civil responsibility on off label prescription drugs, and what is the influence of the informed, free and clarified consent in this equation. For that, it aims to analyze the legitimacy and acceptance of off label drugs, such as the medical civil liability assumptions and the significance of the informed consent as a duty of behavior. We proceed to literary analysis, mainly by doctrine, jurisprudence, scientific papers and national laws. Concludes that informed consent on off label drugs prescription is a fundamental factor, more than just to determine the liability of eventual damage, but to make sure that the individual’s rights and guarantees intrinsic to the human condition are being respected.