The Healthcare Law Review: Brazil
The current Brazilian healthcare framework was defined in 1988 upon enactment of the Federal Constitution. Brazil has developed a dynamic and complex health system based on the principle of access to health as a fundamental right of every person and a duty of the state. The state is responsible for organising a set of initiatives and services to ensure universal, unconditional and unpaid access to healthcare for all citizens. The role of the state encompasses not only taking actions for promotion, protection and recovery of health, but also putting social and economic policies in place to reduce illnesses or their aggravation.
The Unified Health System (SUS) is one of the biggest and most complex public health systems in the world. Jointly with the Federal Constitution, Law 8,080 of 1990 (known as the Organic Health Law) and Law 8,142 of 1990 emphasise the SUS principles and guidelines and set the funding standards for public health initiatives and services.
The SUS operates according to the following principles:2
- universality: all citizens have the right of access to all public health services (or services contracted by the public administration);
- non-discrimination: access to all services is warranted to everyone without discrimination based on race, gender, economic condition, social status, sexual orientation, political views or any social or personal characteristics;
- equity: all citizens have equal rights (in terms of access to and use of services) and will be attended to according to their health needs; and
- comprehensiveness: public initiatives and services at distinct levels of complexity must cover all actions for the promotion, prevention, protection and recovery of health, including their biological, psychological and social dimensions.
The state's healthcare obligations are developed within the SUS by the Ministry of Health in the federal sphere and by the respective healthcare offices in the state and municipal spheres, on a basis of cooperative federalism. In general terms, the federal government sets national guidelines for health policy, the states coordinate their respective regional healthcare networks and municipalities plan out and implement health actions and services alongside other cities within the same region based on the population's needs.
Given this common authority, the bodies of the federation are jointly responsible for meeting healthcare demands and, in view of constitutional criteria of decentralisation and hierarchy, the judicial authority must direct compliance according to rules of division of powers and order the payment of compensation for those bearing the financial burden.3
The National Health Committee (CNS), a joint committee established by Law 8,142 of 1990, is responsible for the strategy and control of public health policies and their economic and financial aspects, thus acting as the highest decision-making body of the SUS.
The Federal Constitution also allowed the private sector to develop healthcare actions and services. Private institutions may participate in the national health system (1) on an accessory basis, by providing input or services or else by engaging in healthcare management with their own resources, following public administration guidelines and on the basis of administrative contracts signed with public entities; and (2) on a supplementary basis, by offering health services through companies operating private health plans and insurance.
Philanthropic and non-profit organisations take precedence over other private entities in providing services for the SUS. However, if the services of those entities cannot be retained or are not enough to meet the SUS demand, the public administration may contract those services for the SUS with private entities for a profit.
Supplementary health is an economic sector served by a significant number of private health plan and insurance operators.
The National Regulatory Agency for Private Health Insurance and Plans (ANS), established by Law 9,961 of 2000, is the agency established by the Brazilian government under the Ministry of Health that operates nationwide to regulate, standardise, control and inspect the private health insurance and plan sector.
Law 10,185 of 2001 provides for the specialisation of insurance companies in private healthcare plans becoming subject to regulation and oversight by the ANS.
The regulatory framework for this sector is found in Law 9,656 of 1998, which contains the regulations on private health and insurance plans.
The National Health Surveillance Agency (ANVISA), created by Law 9,782 of 1999, is the authority primarily responsible for public health control over the production and marketing of designated products and services, including pharmaceutical products and medical devices.
The Ministry of Health, CNS, ANS and ANVISA are the government bodies primarily tasked with enforcement of healthcare laws and rules.
The SUS serves approximately 75 per cent of the Brazilian population. The remaining citizens (circa 48 million Brazilians)4 have a private healthcare plan. Private healthcare is the asset third most desired by non-beneficiaries, behind only education and home ownership,5 and largely as a result of shortcomings in public sector healthcare provision due to, among other factors, budgetary constraints and a shortage of skilled labour in the medical and dental areas, as well as the continental dimensions of the country. The process of 'exclusionary universalisation' established by the SUS has given a strong impulse to the private healthcare sector recently.
The line between public and private healthcare services has always been somewhat blurred, with their coexistence resulting sometimes in overlapping and inefficiencies. Users may resort to either side of the system depending on their actual needs or financial resources. Although disparate and uncoordinated, these two sectors are interdependent. They do not exclude or replace each other, given the universal character of the SUS. However, the medical records for the same user are not shared between the public and private sectors, which creates inefficiencies in the health system.
Since the beginning of 2020, the covid-19 pandemic has brought up discussions about the coexistence and need for interconnection between these two subsystems, especially considering the high possibility of hospital overload, understaffing, shortage of medical services and equipment, lack of sufficient data integration between public and private systems to manage the public health crisis and its developments, and revealing how significant and urgent this topic is for better and more effective management of healthcare in Brazil.
Patients regularly choose between the SUS and the private healthcare sector after considering their medical condition, treatment complexity, and proximity of available facilities, among other factors. Under Article 32 of Law 9,656 of 1998, private healthcare providers must reimburse the SUS for the public treatment costs of those covered by a private healthcare plan.
The Brazilian health system has also been affected by other global dilemmas. As identified by Willis Towers Watson,6 the population will age in the next decades at a faster rate, putting more pressure on the already overburdened healthcare system. Unnecessary treatments, the incorporation of costly new technologies, the expansion of mandatory procedures to be covered by private health providers and judicial decisions obliging the state and private operators to cover unanticipated medical treatments are also key factors tipping the scale unfavourably for the Brazilian health system.
The healthcare economy
The SUS struggles to overcome obstacles to provide the right established in the Federal Constitution of a healthcare system that is 'free and available to all', with one of the most difficult obstacles being cost. Serving more than 200 million people, 80 per cent of whom are fully dependent on its services and resources, the SUS is heavily reliant on state funding.
As for funding of the public system, Law 8,142 of 1990 provides for the intergovernmental transfer of financial resources. Constitutional Amendment No. 297 aims to ensure the funding of public health initiatives and services by establishing minimum resources to be provided by the three spheres of government. Funding for the SUS comes from tax revenues and social contributions from the federal, state and municipal budgets.
According to a study carried out by the Federal Council of Medicine (CFM) in November 2018,8 the amount of funding remains below international standards and is insufficient to cope with the growing demands of the population, driven by changes in socioeconomic and epidemiological profiles. The fiscal austerity policies implemented by the government a few years ago have aggravated the problem by freezing health service expenses for the next 20 years.
Brazil allocates only 3.8 per cent of its gross domestic product to the public health system, a very low percentage compared to other countries (e.g., Portugal 6.2 per cent, United Kingdom 7.6 per cent, and France 9 per cent).9 The SUS funding mechanisms have not been adequate to the task of securing sufficient financial resources for the public system.
ii The role of health insurance
Given the shortcomings in the public service, the purchase of private health insurance, albeit not mandatory, appears an attractive alternative. In March 2019, the ANS reported the existence of approximately 47 million private plan beneficiaries.10
Corporate health insurance plans serve the vast majority of these beneficiaries. Employers are the main source of funding for private healthcare participants, which offer health services – directly or indirectly (through full or partial funding) and through health plans managed by an operator or insurer – to their employees, who in turn represent approximately 70 per cent of private health plan beneficiaries.
Families and individuals also play a relevant role in the private health sector by financing directly the services rendered by healthcare service operators and providers or by acquiring medicines or medical devices.
Public and private systems coexist not only for funding and management, but also in the offer and use of health services. There is direct and indirect public subsidy for health plans, ranging from tax exemptions for operators, providers and clients of health plans (whether individuals or corporations) to the purchase of private plans for public servants and reimbursements paid to the SUS (when a beneficiary of a private health plan uses public services covered by the private healthcare plan). In 2019, the ANS made a record transfer of 1.15 billion reais to the SUS, which represents an increase of about 47 per cent compared to 2018, which held the previous record. In 2020, the total amount transferred to the Fund was 816.24 million reais. In 2021, a slight reduction is expected in relation to the previous year and, subsequently, maintenance of the annual transfer levels.11
iii Funding and payment for specific services
The National Commission for Incorporation of Technologies (CONITEC) advises the Ministry of Health on incorporation, exclusion or alteration of health technologies by the SUS, as well as on the creation or alteration of clinical protocols and therapeutic guidelines. In this context, legislation sets a period of 180 days (extendable for 90 days) for decision-making through a healthcare technology assessment,12 which includes evidence-based analysis and takes into account such aspects as efficacy, accuracy, effectiveness, safety of the technology and even its impact – not only from a financial perspective, but also from a social, organisational, ethical and legal point of view. CONITEC also undertakes economic evaluations of benefits and cost comparisons with existing technologies.
In terms of private healthcare, the scope of coverage – including transplants and highly complex procedures – is defined by the ANS, which also sets the corresponding rules of use. Every two years, the List of Healthcare Procedures and Events (the ANS List) is revised and updated and, from then on, all procedures and treatments qualifying for compulsory coverage by private health plans are made public, without prejudice to any additional coverage stipulated in private health contracts.
The extent of care coverage by public and private health systems has always been disputed in Brazilian courts, particularly the coverage of high-cost drugs and procedures not offered by public and private health systems and the off-label use of medical products or treatments (i.e., those used in the treatment of conditions for which the use of those products or treatments is not authorised by the government agency and accordingly is not indicated in the product labelling).
In 2020 and beginning of 2021, the Superior Court of Justice (STJ) rendered landmark decisions on this matter, with the following being worthy of note:
Special Appeal No. 1.876.630/ – the STJ justices reaffirmed the understanding that the ANS List only refers to mandatory coverage procedures based on Normative Ruling 428/17, with the possibility of other events and procedures being covered, in opposition to Special Appeal No. 1.733.013/SP, which had established that the ANS List is exhaustive in terms of minimum coverage for health plan operators, thus preserving the economic-financial balance of the supplementary health system (given the domino effect of such decision on other similar claims) and the legal certainty to contractual relationships.
The dispute will be resolved by the Second Section of the STJ based on motions for divergence that do not yet have a scheduled date for judgment.
Special Appeal No. 1.818.487/SP, Special Appeal No. 1.816.482/SP and Special Appeal No. 1.829.862/SP (Topic 1,034) – the Second Panel established three events that define assistance and funding conditions to be maintained for inactive beneficiaries (retired employees) under Article 31 of Law 9,656 of 1998, as follows:
- the calculation of the contribution period to the collective corporate health plan by the retired former employee when he was active for the purposes of calculating the period of his contribution to this plan after termination of the employment relationship;
- the active and inactive beneficiaries are included in the single collective health plan containing the same conditions of care coverage, which includes for all universe of beneficiaries, equal payment conditions model and contribution amount, differentiation of age bracket being accepted if contracted for all, and the inactive being responsible for full payment, which amount can be obtained by adding up his quota with the amount that proportionally is supported by the employer in relation to the active beneficiaries; and
- the retired former employee who fulfilled the requirements of Article 31 of Law 9,656/98 has no vested right to remain in the same private healthcare in force at the time of retirement, and there may be the replacement of the operator.
Those recent precedents illustrate the trend for the Brazilian higher courts to look favourably on the limits and standards established by the state and its existing regulations in providing health services to citizens.
Primary/family medicine, hospitals and social care
The Federal Constitution determines that public health initiatives and services should together create a regionalised and hierarchical network. Following this guideline, health regions were created, which are, in brief, territorial administrative and sanitary divisions that allow the population access to treatment most suited to local needs. Under Decree 7,508 of 2011, these health regions should contain at least primary care, urgent and emergency care services, psychosocial care, specialised outpatient and hospital care and health surveillance.
In 2017, the federal government instituted the National Primary Care Policy to expand clinical care and focus on primary care, while avoiding unnecessary medical appointments or procedures.
The National Primary Care Policy adopts the same principles as the SUS (universality, non-discrimination, equity, comprehensiveness) and should be the preferred reference entry point in relation to public health services.
Following the same public sector rationale, the ANS issued Normative Ruling 440 of 2018 establishing the Programme for Certification of Good Healthcare Practices of Private Healthcare Plan Operators (APS), which is a voluntary process to evaluate the adequacy of preset technical criteria for specific healthcare networks or of operators' specific care lines, with the evaluation being carried out by health accreditation entities recognised by the ANS.
The APS certification proposes a model for reorganisation of the gateway based on primary healthcare, to induce change in the gateway and in the remuneration model for value generation. Based on the main structuring pillars for primary healthcare as provided in national and international scientific literature, the programme focuses on reception, patient care, coordination and integral care, recognition of the heterogeneity of demands, centrality in the family and community orientation.
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.
ii Institutional healthcare providers
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.
iii Healthcare professionals
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.
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).
Ownership of healthcare businesses
Under Law 9,656 of 1998, individuals or legal entities resident or domiciled abroad may set up or hold equity interests in healthcare operators. After extensive discussions on the matter, Law 13,097 of 2015 also established exceptions to the constitutional prohibition against direct and indirect participation of foreign capital in healthcare activities. As a result, significant foreign investments have been made more recently in this industry.
The opening of the market to foreign investment, the provision of national investment funds and the going public of healthcare companies boosted a strong movement of mergers and acquisitions in the private health market.
From 2003 to 2017, CADE analysed and judged 155 merger filings (termed 'concentration acts') involving companies in the healthcare industry. During this period, the growth and consolidation of certain economic groups that have since become industry leaders were monitored, and it was found that the merger and acquisition of companies had been adopted as the main strategy for expansion in the industry. Amil, Rede D'Or, Dasa, Fleury, Unimed, Qualicorp and NotreDame Intermédica were, in this order, the most active companies engaged in this trend, and were responsible for 80.98 per cent of the total number of deals.16
Commissioning and procurement
All purchases and contracts for services undertaken by the public administration must be preceded by public bidding procedures as established by Law 8,666 of 1993. The requirements for tendering bids or executing public contracts are usually established beforehand in the formal document prepared at the beginning of the bidding process.
Marketing and promotion of services
Several restrictions apply to the marketing and promotion of health services in Brazil. The main advertising watchdog in Brazil is the National Council for Advertising Self-Regulation (CONAR), but there are also restrictions imposed by the ANS, ANVISA and professional councils (the CFM and CFO), and others set out in the CDC.
The Brazilian Code of Self-Regulation issued by CONAR establishes restrictions on the advertising of health-related services (in Annex G), prohibiting, among other things, advertisements or materials announcing (1) cures for diseases for which no adequate treatment yet exists, (2) distance or remote diagnosis or treatment, and (3) treatment and diagnosis methods not yet scientifically established.
Between 2012 and 2018, CONAR commenced 396 proceedings involving health services and issued 99 decisions, of which only 18 moved to dismiss the case. In the other cases, CONAR ordered the advertising campaign to be changed or suspended.
Among the relevant cases analysed by the CONAR board, a decision issued in March 2019 ordered the suspension of a drug advertisement claiming that the product cured pain and fever caused by the dengue, zika and chikungunya diseases; this suspension is to remain in effect until official studies verify the accuracy of the reported indications.17
In a supplement to the CONAR regulations, the CFM has banned doctors from posting selfies, images or aids characterised by 'sensationalism, self-promotion, or unfair competition'. The CFO, for its part, prohibits the use of before-and-after images of procedures in advertisements.
The year 2020 was one of the most complex and challenging years due to the outbreak and spread of the new coronavirus, which negatively affected and is still affecting the health, economies and social well-being of populations.
The ANS has discussed with healthcare sector participants the implementation of several measures to fight the covid-19 pandemic, aiming to guarantee coverage to the beneficiaries, sustainability of the sector and to maintain healthcare plans and insurance. These include:
- extraordinary inclusion of tests to detect covid-19 in the ANS List;
- maximum extension of the deadlines for consultations, exams, therapies and elective surgeries, in order to reduce the burden of health units and avoid unnecessary exposure of beneficiaries to contamination risks; and
- creation of more flexible economic and financial regulations so that operators can prioritise actions to combat covid-19, establishing counter parties to protect beneficiaries and the network of service providers.
Despite the pandemic, the private healthcare sector had a year of important initiatives that contributed to the increase of the sector and the improvement of the provision of services to the beneficiaries, showing the continued encouragement of the adoption of a more efficient, effective and sustainable healthcare model, focused on patient care, the growing index of positive outcomes in the intermediation and resolution of conflicts between beneficiaries and operators, the review and adaption of outdated regulation, increasing the transparency, adopting technologies to provide healthcare services and reducing information asymmetry in the sector.
Future outlook and new opportunities
The Brazilian health system faces enormous challenges that have to be addressed if the system is to continue in the role assigned to it by the Federal Constitution. In this context, and particularly with regard to the supplementary health system, health market participants (including the ANS and ANVISA as industry regulators) often come together to discuss strategic issues and opportunities, some of which are outlined below.
As defined in Resolution 1,643 of 2002 issued by the CFM, telemedicine is the exercise of medicine through the use of interactive methodologies of audiovisual communication and data, with the objective of healthcare, education and research. On 6 February 2019, the CFM issued a new regulation on this matter18 defining and regulating telemedicine throughout the national territory and providing for procedures such as telediagnosis and telesurgery, and also determining the level of data security for patients served through telemedicine. This new regulation, however, was later revoked, but it will only be a matter of time until it is improved and republished so that health services can be provided to patients in distant and inaccessible areas at a more reasonable cost.
In response to the covid-19 pandemic, social distancing and self-isolation have been the solution adopted in an attempt to prevent further spread of the virus. In response to these circumstances, the CFM recognised the use of telemedicine in Brazil, on an exceptional and temporary basis, to ensure regular medical assistance while the pandemic lasts. On 31 March 2020, the ANS underscored the need to adjust its regulations to the current scenario (temporary authorisation for telemedicine). Among other measures, the ANS highlighted the need to adapt the rules on contracting between operators and service providers in relation to in-scope services and the place where they are provided. However, the ANS pointed out that in-person services remain compulsory for healthcare operators if the beneficiary does not have the resources for remote attendance or lacks in the necessary skills for teleservice.
For its part, Law 13,989 of 2020 temporarily authorised telemedicine in Brazil. Although telemedicine has been implemented in Brazil as an alternative, temporary and emergency measure to cope with the health crisis caused by the covid-19 pandemic, this type of medicine does make it possible to reach a greater number of patients and is likely to gain traction in the coming years.
ii Emergence of new products
'New products' are coming out in the private sector whereby the population is being provided with healthcare services that are not subject to oversight by the ANS and, by extension, to its minimum coverage requirements.
iii Adoption of different remuneration models
Revamping the current system for remuneration to hospitals and laboratories is critical, since the variation in hospital and medical costs for healthcare providers represents one of the main factors for the soaring increase in annual costs. The adoption of alternative remuneration mechanisms, such as fees for performance, may help reduce both healthcare costs and cases of fraud involving medical devices and medicines.
iv Focus on prevention and promotion of health programmes
Aiming to foster health and well-being rather than treating diseases alone, the ANS is seeking a paradigm shift by encouraging operators to rethink the management of plans to focus on actions to maintain the health of beneficiaries. This is a topic of the ANS Regulatory Agenda for 2019–2021, which is undergoing public consultation, and reflects a global trend. These efforts are expected to culminate in a guiding set of strategies and integrated programmes targeting risk reduction, compression of morbidity, and a better quality of life, leading to a more robust engagement by beneficiaries and ultimately reducing costs.
v Adaptation of health market participants to the General Law on Data Protection
Law 13,709 of 2018, known as the General Law on Data Protection (LGPD), will impact all relationships within the public and private health sectors, including health plan operators, service providers, collective plans contracting entities and other participants that have access to personal data on health insurance and plan beneficiaries. Sensitive health data, already protected by medical confidentiality, is to be shared with those in the private healthcare chain in charge of capturing information that can help improve the quality of life of beneficiaries. This measure will be highly beneficial to data subjects, will favour beneficiaries and will also be used by health plan operators for plan pricing purposes. This more effective management of care, including directing beneficiaries to more cost-effective providers for treating specific illnesses, will make it possible to focus on campaigns and actions against major chronic diseases.
The LGPD was due to enter into force in August 2020. However, because of the covid-19 crisis, the Senate unanimously postponed the initial effective date for imposition of sanctions arising from the LGPD, and its general effects, until August 2021.
In Brazil, the public and private healthcare systems coexist. However, the lack of policies and mechanisms for better coordination between the two sectors may explain some of the inefficiencies found in the health system and this lack deserves priority attention from all industry participants, the more so in view of the recent challenges posed by the covid-19 pandemic.
Like other systems in the world, the Brazilian health system has been affected by global dilemmas and faces great challenges, starting with the guarantee of effective access, better quality of healthcare, technology, the financial sustainability of the sector and health promotion for all. In this context, industry participants have been discussing the future of the health system in pursuit of concrete proposals that tackle these challenges and identify opportunities to improve the quality of services and reduce their increasing cost.
1 Théra van Swaay De Marchi is a partner and Maria Silvia L de Andrade Marques is a counsel at Pinheiro Neto Advogados.
3 Thesis of general repercussion on the constitutional matter (leading case status) in Extraordinary Appeal 855178 set by the STF on 23 May 2019; http://www.stf.jus.br/portal/cms/verNoticiaDetalhe.asp?idConteudo=411981 (accessed 27 May 2019).
4 Available at the Virtual Library of ANS: https://www.gov.br/ans/pt-br/assuntos/noticias/numeros-do-setor/ans-disponibiliza-numeros-do-setor-relativos-a-abril.
5 Research carried out by IBOPE Inteligência in 2017, at the request of Instituto de Estudos de Saúde Suplementar (IESS): http://www.ibopeinteligencia.com/noticias-e-pesquisas/cresce-satisfacao-de-beneficiarios-com-seus-planos-de-saude/.
6 '2019 Global Medical Trends Survey Report': http://www.willistowerswatson.com/-/media/WTW/PDF/Insights/2018/11/2019-global-medical-trends-survey-report.pdf.
7 Constitutional Amendment No. 29, enacted on 13 September 2000 and further regulated by Supplementary Law 141 of 2012.
9 Figueiredo, Juliana Oliveira; Prado, Nilia Maria de Brito Lima; Medina, Maria Guadalupe; PAIM, Jairnilson Silva. 'Public and private expenditures with health in Brazil and selected countries', Revista do Centro Brasileiro de Estudos e Saúde, Vol. 42, Número Especial 2, Rio de Janeiro, Out. 2018, pp. 37–45.
10 Data related to the private sector provided by the ANS: http://www.ans.gov.br/perfil-do-setor/dados-gerais.
It is important to note that not all services rendered to beneficiaries of private health plans qualify for compensation, only those services provided by the operator of a private health plan established in the List of Medical Procedures and Events issued by ANS or in the agreement.
12 Minstry of Health guide explaining healthcare technology assessment (avaliação de tecnologia de saúde): http://bvsms.saude.gov.br/bvs/publicacoes/entendendo_incorporacao_tecnologias_sus_envolver.pdf.
13 The Administrative Council for Economic Defence (CADE) is an independent agency reporting to the Ministry of Justice tasked with assessing all corporate restructurings that could affect free competition in the national territory.
14 Normative Ruling 124 of 2006 issued by the ANS.
15 REsp No. 1.725.092/SP, Reporting Judge Nancy Andrighi, Third Panel, published in the Online Court Gazette on 23 March 2018.
16 'Concentrations in the healthcare market, hospitals and diagnostic medicine', published by CADE in July 2018.
17 Formal Complaint 029 of 2018; a description of the decision is available on the CONAR website.
18 Resolution CFM 2,227.