Off-label and experimental treatment healthcare coverage and the essential right to health

Abstract

Background: This study outlines theoretical and structural aspects of health insurance coverage for diseases that require off-label or experimental treatment. Problem: It questions the essentiality of the right to health, objective good faith, and the invasion of contractual minimum fundamental rights, regarding the (il)legality contained in the denial of health care for off-label or experimental treatments. Objectives: To differentiate off-label treatment from experimental treatment; to demonstrate under what conditions health care coverage for treatment not provided for in the list can be considered mandatory based on the Health Insurance Law; and to evaluate the conduct of the operator in light of public order precepts linked to objective good faith. Methods: Qualitative research, with an exploratory, descriptive, and critical approach. Results: Legal and regulatory texts were collected that allow the legal approach and autonomy of medical conduct in therapeutic guidance for off-label and experimental treatments. Conclusions: It was found that, structurally, off-label and experimental treatments are different, although both must meet specific conditions to be authorized. Operators are not responsible for the technical decision on coverage and their refusal, given the framework raised, may constitute a breach of objective good faith.