Medical Law in Brazil

Introduction

Medical law in Brazil (Direito Médico or Direito da Saúde) governs the practice of medicine, patient rights, healthcare regulation, and liability for medical malpractice. The legal framework integrates constitutional provisions on health as a universal right, the Federal Council of Medicine (CFM) regulatory authority, the Unified Health System (SUS), and civil and criminal liability regimes. The field has grown significantly with advances in medical technology, the expansion of telemedicine, and increased judicial oversight of healthcare delivery.

Constitutional and Regulatory Framework

Right to Health

The 1988 Constitution recognizes health as a fundamental right and establishes the Unified Health System (SUS) as a universal, equitable, and comprehensive public health system (Articles 196-200). Article 196 provides that health is “a right of all and a duty of the State,” imposing positive obligations on the government to provide healthcare services.

Federal Council of Medicine

The Federal Council of Medicine (Conselho Federal de Medicina, CFM), created by Law 3.268/1957, is the regulatory body for the medical profession. Its powers include: (i) professional licensing and registration; (ii) issuance of ethical standards through resolutions; (iii) disciplinary proceedings against physicians; and (iv) advisory opinions on medical ethics.

CFM resolutions have significant legal force and address topics including: (i) medical records; (ii) end-of-life decisions; (iii) assisted reproduction; (iv) organ transplantation; (v) medical advertising; and (vi) telemedicine.

Patient Rights

Informed Consent

Informed consent (consentimento informado or consentimento livre e esclarecido) is a fundamental requirement of medical practice. The Civil Code (Article 15) provides that “no one may be compelled to undergo a medical or surgical treatment that involves risk to life,” and medical ethics codes require physicians to obtain consent after providing clear information about risks, alternatives, and consequences.

The CFM has issued detailed resolutions on consent forms for specific procedures. Courts have held that failure to obtain proper informed consent constitutes a violation of patient autonomy and may ground liability even when the treatment was performed correctly.

Medical Records and Confidentiality

Patients have the right to access their medical records, and physicians must maintain confidentiality of patient information. The General Data Protection Law (LGPD, Law 13.709/2018) applies to health data as sensitive personal data (Article 5, II), imposing additional requirements for processing, including explicit consent and special security measures.

Patient Rights in the SUS

Users of the SUS have rights established by the National Health Council (CNS), including: (i) access to quality, timely care; (ii) information about health conditions and treatment options; (iii) participation in treatment decisions; and (iv) complaint mechanisms.

Medical Malpractice

Civil Liability

Medical malpractice liability (responsabilidade civil médica) is governed by the Civil Code. Brazilian law adopts subjective liability (responsabilidade subjetiva) for physicians — based on proof of fault (culpa) — unless the obligation is one of result rather than means.

• Obligations of means (obrigações de meio): The physician must employ all appropriate means to achieve the desired result, without guaranteeing success. Most medical obligations fall into this category.

• Obligations of result (obrigações de resultado): The physician guarantees a specific result, such as in cosmetic surgery (STJ, Resp 236.708/SC). In these cases, the burden of proof shifts to the physician to show that the failure was not their fault.

For healthcare institutions (hospitals, clinics), liability is objective (objetiva) under Article 14 of the Consumer Protection Code (CDC), as healthcare services are considered consumer services.

Criminal Liability

Medical criminal liability applies in cases of criminal negligence (negligência), recklessness (imprudência), or malpractice (imperícia) resulting in bodily injury or death (Penal Code, Articles 129 and 121). The standard is higher than for civil liability, requiring proof of recklessness or serious negligence.

Expert Evidence

Medical malpractice cases typically require expert evidence (prova pericial), appointed by the court or selected by the parties. The court expert must be a physician with appropriate specialization. The STJ has held that the judge is not bound by the expert opinion but must provide reasoned grounds for departing from it.

Telemedicine

Regulatory Development

Telemedicine in Brazil experienced rapid expansion during the COVID-19 pandemic. The CFM issued Resolution 2.314/2022, establishing requirements for telemedicine, including: (i) prior in-person consultation for initial appointments (with exceptions for specific situations); (ii) physician oversight of remote consultations; (iii) appropriate technology for data security; and (iv) maintenance of medical records.

State Legislation

Several states have enacted telemedicine legislation, creating a decentralized regulatory framework. Federal legislative proposals seek to harmonize telemedicine regulation at the national level.

Bioethics

National Health Council

The National Health Council (CNS) and the National Commission on Research Ethics (CONEP) regulate research involving human subjects, implementing international ethical standards (Declaration of Helsinki) through CNS Resolution 466/2012.

End-of-Life Decisions

Brazilian law prohibits euthanasia and assisted suicide. The CFM Resolution 2.217/2018 (Medical Ethics Code) prohibits physicians from performing or cooperating with euthanasia. Palliative care is permitted, and the distinction between palliative treatment and euthanasia is recognized. Advance directives (diretivas antecipadas de vontade) are recognized by CFM Resolution 1.995/2012.

Conclusion

Brazilian medical law integrates patient protection, professional regulation, and public health obligations within a constitutional framework that recognizes health as a fundamental right. The SUS provides universal healthcare, while the CFM regulates professional practice. The evolving areas of telemedicine, medical data protection, and bioethics continue to shape the field, with Brazilian courts playing an active role in defining the scope of patient rights and professional responsibilities.