Spotlight: the regulation of healthcare providers and professionals in Brazil

All questions

The licensing of healthcare providers and professionals

Companies that independently and exclusively provide healthcare services or coverage for healthcare costs, at a preset or post-set price, for an indeterminate period, are regarded as health plan carriers, for purposes of securing medical, hospital and dental care expenses without a financial limit.

Other activities are also equated by law to those of operators, when they present, in addition to the security for financial coverage of healthcare risks, other characteristics that differentiate them from an exclusively financial activity.

The Ministry of Health, the ANS and ANVISA are the government bodies primarily tasked with enforcing the laws and rules on delivery of healthcare at federal level.

The Ministry of Health is the highest public health authority and, as such, is responsible for establishing general rules to implement and organise the SUS, as well as for defining, monitoring and evaluating the national health surveillance policy; this authority is supplemented by local rules relating to healthcare initiatives and services targeting local interests.

The ANS is responsible for regulating, standardising, controlling and inspecting private health insurance and plans, and also for planning industry-level initiatives in Brazil.

Mergers, acquisitions or any corporate restructuring entailing a change or transfer of control of senior managers or insurers are subject to prior clearance from the ANS. In January 2019, the ANS and the Administrative Council for Economic Defence (CADE)¹³ signed a technical cooperation agreement consolidating their institutional relationship and aiming (1) to improve local monitoring of levels of concentration in the private health market thus protecting competition in this industry; and (2) to train staff through bilateral events and exchange of public servants for joint production of studies and research, among other initiatives.

ANVISA is responsible for public health control in relation to the production and marketing of designated products and services (including pharmaceutical products and medical devices), including in related environments, processes and technologies, and for ports, airports and borders.

Institutional healthcare providers and healthcare professionals are subject to licensing and rules issued by professional bodies such as the CFM, the Federal Council of Dentistry (CFO), the Federal Council of Pharmacy, and the corresponding regional councils for these professions.

Companies must first obtain a licence for operation as a private healthcare insurer, subject to the documentary and other requirements established by Normative Ruling 85 of 2004 issued by the ANS. Once in possession of this licence, the healthcare operator may apply for registration of the products it intends to sell in the private health market.

The sanctions for private health insurers found to be in contempt of the ANS determinations include fines, suspension of sales, supervisory intervention, mandatory portfolio transfer and cancellation of registration.¹⁴ Acting as a private health plan operator without a licence is one of the most serious infractions, punishable by a daily fine until cessation of the activity, compliance with the authorisation requirements or correction of an irregular and unlawful dissolution of a legal entity, or else until the date when in relation to the operator the ANS decrees the adoption of a technical or fiscal regime, liquidation or disposal of portfolio.

Supervisory intervention concerning financial, economic or technical matters is decreed (depending on the severity of the case) when the ANS detects poor financial backing or severe administrative, economic or financial anomalies in any private health insurer that may impair the continuity and quality of services rendered to beneficiaries.

No company with customers or in debt to the network of healthcare providers may cease its operations. The existence of customers also prevents the cancellation of product registrations. Any private health insurer wishing to cancel its licence must comply with all legal requirements established by the ANS.

The regulation of healthcare professionals is extensive. All doctors, dentists, pharmacists and nurses must be licensed. In general, professional healthcare activity is regulated by federal councils, which in turn establish that these professionals must be registered with regional councils. Enrolment with the competent authorities is compulsory and infringement may translate into criminal sanctions, such as fines and detention from six months to two years.

Licensing of doctors is regulated by Federal Law 3,268, by Decree 44,045 and by the code of professional ethics. In brief, doctors must have their titles registered with the Ministry of Education and also be registered with the competent regional council of medicine. Furthermore, all technical reports and patient records must contain the corresponding doctor's number of registration with the competent regional council of medicine, under penalty of ethical sanctions.

The same requirement to register with a regional council applies to dentists (pursuant to Federal Law 4,324, Decree 68,704 and the Code of Ethics in Dentistry).

When it comes to nurses, mandatory registration with the regional councils is set by Federal Law 2,604, and the nursing ethics code emphasises that nurses can refuse to execute a prescription unless it contains the applicable doctor's regional council of medicine registration number. The mandatory licensing of pharmacists is regulated by Federal Law 3,820.

In cases of breach of applicable laws, healthcare professionals can be punished with disciplinary sanctions, such as warnings, censorship, fines, suspension or withdrawal of the licence to practise. Professionals can appeal against any disciplinary decision. Unlicensed professionals cannot provide health services. However, unlicensed professionals can render some services related to the healthcare industry, if supervised by a licensed professional.

International graduates can be registered to render health services, but they must take the National Examination of Revalidation of Medical Diplomas Issued by Foreign Universities, established by Ordinary Law 13,959 of 2019.

Negligence liability

A consumer relation exists between patients and healthcare providers, so the rules of liability established by the Civil Code and the Consumer Protection Code (CDC) apply.

Physicians must always act diligently, clearly informing patients about the characteristics of their pathology, treatment alternatives, risks of treatment or medical procedure (if any), and using all existing know-how for the patient's care and treatment.

In fact, according to most court rulings, at-fault liability applies to doctors, who are held liable when guilt is proven in any of its modalities (recklessness, negligence or malpractice).

The STJ¹⁵ has already decided that a contractual relationship exists between healthcare professionals and patients, and the provision of services (according to the expertise and medical resources available under the circumstances) is part of the concept of obligation of means, except in the case of aesthetic plastic surgeries (obligation of result). Hospitals, laboratories, clinics and other healthcare providers (including those operated by the state, directly or indirectly) are subject to strict liability, based on Article 14 of the CDC and Article 27 of the Civil Code.

Healthcare operators are liable to the consumer, jointly and severally, for defective medical and diagnostic services, whether those provided through their own hospital and contracted doctors or through accredited doctors and hospitals (Articles 2, 3, 14 and 34 of the CDC).