In general terms, how is healthcare, including access to medicines and medical devices, funded in your jurisdiction? Outline the roles of the public and private sectors.
The Brazilian Federal Constitution sets forth a series of fundamental rights, including the right to healthcare. In this sense, the Brazilian federal government, in addition to carrying public health assistance activities, established social and economic policies for health protection and for the provision of medical services to all citizens.
Accordingly, the federal government established the Universal Health System (SUS), one of the largest public health systems in the world. SUS comprises a series of actions and healthcare services provided free of charges by federal, state and municipal public institutions (including governmental entities and foundations maintained by the government). It ranges from simple outpatient care to organ transplantation, ensuring full, universal and free healthcare access for the entire Brazilian population. As a rule, SUS provides access to medicines exclusively as part of the provision of its healthcare services (ie, during a hospitalisation of period). For patients who require continuous use of medicines, the federal government establishes public-funded programmes that cover certain medicines and medical devices.
SUS is funded via federal, state and municipal funds - in 2017, for instance, SUS had a total budget of 265 billion reais, of which 115 billion (43 per cent) were federal funds, 82 billion were municipal funds (31 per cent) and the remaining 68 billion reais (26 per cent) were state funds. In addition to public healthcare service facilities, SUS also funds private healthcare facilities (preferable philanthropic and non-profit organisations) that support its offer of public and universal healthcare.
In parallel, the federal government encouraged the participation of private companies in the healthcare sector. Accordingly, the federal government defined the rules applicable to healthcare plans and to the creation, organisation, operation and inspection of healthcare plans operators (HMOs). Pursuant to the applicable regulation, these plans must have a minimum proceeding coverage. As a rule, HMOs must grant access to medicines exclusively as part of their healthcare services. HMOs usually do not provide coverage for medicines and medical devices for continual use.Delivery
In general terms, how is healthcare delivered in your jurisdiction? Outline the roles of the public and private sectors.
On the public sector side, SUS healthcare activities are guided by the constitutional principles of universality, equity, integrity and social participation. These principles set forth that:
- access to healthcare is a constitutional right of all citizens;
- the system must invest its resources in accordance with regional and local needs; and
- healthcare includes not only health promotion, but also diseases prevention, treatment and rehabilitation.
In this sense, SUS is responsible for:
- execution of actions in sanitary and epidemiologic surveillance;
- therapeutic care;
- healthcare policy elaboration;
- nutritional orientation; and
- promotion of scientific and technologic development, among other responsibilities.
Despite there being public and universal healthcare, there are concerns over the availability and quality of SUS services.
The private sector encompasses individual users who pay healthcare service providers directly from personal funds and HMOs that offers healthcare plans (individual or group policies or contracts, usually funded by employers for its employees and family members). According to the Ministry of Health, in 2017, 47.3 million Brazilians had healthcare plans. It is important to highlight that even private sector users may access SUS. In such cases, HMOs are usually required to reimburse SUS for the services provided.Key legislation
Identify the key legislation governing the delivery of healthcare and establishing the regulatory framework.
The key legislation governing the delivery of healthcare is:
- the Brazilian Federal Constitution of 1988, mainly articles 196 to 200;
- Federal Law No. 8,080 of 1990, which defines the organisation of the Brazilian healthcare system;
- Federal Decree No. 7,508 of 2011, which regulates Federal Law No. 8,080 of 1990;
- Federal Law No. 9,961 of 2000, which creates the National Private Healthcare Insurance and Plans Agency (ANS);
- Federal Law No. 9,782 of 1999, which establishes the National Sanitary Surveillance Agency (ANVISA);
- Federal Law No. 6,437 of 1977, which establishes violations of federal health legislation; and
- Federal Law No. 9,656 of 1998, which regulates the provision of private healthcare insurance and plans.
Which agencies are principally responsible for the enforcement of laws and rules applicable to the delivery of healthcare?
The ANS agency, the Ministry of Health, state and municipal sanitary departments, and professional councils of healthcare activities are the primarly responsible authorities for the enforcement of laws and rules applicable to the delivery of healthcare.
ANS is a regulatory agency linked to the Ministry of Health, which aims to regulate HMOs activities in Brazil and, at the same time, protect the public interest. To reach these goals, ANS regulates interactions among HMOs, service providers and consumers. In general, HMOs must be registered with ANS and comply with its regulations to operate efficiently. ANS is primarily funded via federal taxes collected from HMOs. Additionally, part of the fines imposed by the agency are reverted to its operation budget.
Healthcare facilities are also regulated by the Ministry of Health. They must be registered and maintain their registration with the National Registry of Health Facilities (CNES). The Ministry of Health is primarily funded via federal taxes. Part of the fines and taxes collected by agencies subject to its supervision (ie, ANS) also revert to its budget.
Establishments that perform activities in the healthcare sector shall also hold sanitary permits issued by state or municipal sanitary departments, depending on how decentralised sanitary supervision is in that specific state. These departments are primarily funded via state or municipal taxes.
Finally, professional councils of healthcare activities (such as the Federal Council of Medicine and the Federal Council of Nursing) are responsible for registering and inspecting healthcare professionals and service providers, with respect to the ethical and professional regulation of their professions.Scope of enforcement
What is the scope of their enforcement and regulatory responsibilities?
As a rule, regulatory enforcement regarding delivery of healthcare has the following scope:
- control, supervise and monitor HMOs;
- propose, monitor and implement policies, guidelines and rules on healthcare;
- authorise or prohibit operations and advertising of healthcare services;
- coordinate and monitor the financial condition of HMOs; and
- establish minimum coverage and price readjustment for healthcare.
Which agencies are principally responsible for the regulation of pharmaceutical products and medical devices?
ANVISA, Chamber of Medicine Market Regulation (CMED) and state or municipal sanitary departments are the primarily responsible authorities for the regulation of pharmaceutical products and medical devices.
ANVISA is a regulatory agency linked to the Ministry of Health, which regulates pharmaceutical products and medical devices. ANVISA is directly funded by the federal government via federal taxes. In addition, fines and taxes collected by ANVISA are indirectly reverted to its operation costs via the National Health Fund.
CMED is an inter-ministerial body responsible for regulating the market of medicines and the ceiling price of such products.
Additionally, establishments that manufacture, distribute, storage and market medicines are also regulated by state or municipal sanitary departments, depending on how decentralised is sanitary supervision in that specific state. These departments are primarily funded via state or municipal taxes.Scope of enforcement
What is the scope of their enforcement and regulatory responsibilities?
ANVISA’s main scope is to promote the protection of the population’s health by executing sanitary control of the production, marketing and use of products and services, subject to health regulation (mainly pharmaceutical products and medical devices), including related environments, processes, ingredients and technologies.
ANVISA also executes sanitary controls in ports, airports and borders.Other agencies
Which other agencies (eg, competition or securities regulators, prosecutors) have jurisdiction over healthcare, pharmaceutical and medical device cases?
The principal agencies that have jurisdiction over healthcare, pharmaceutical and medical device cases are:
- the Administrative Council for Economic Defence (CADE), the Brazilian antitrust agency;
- the Brazilian Securities Commission, for listed companies;
- the Federal and State Public Prosecutors, for public law and criminal offences oversight;
- the Consumer Administrative State Council, for consumer protection matters;
- the Brazilian Environment and Renewable Natural Resources Institute and state and municipal environmental authorities; and
- the Ministry of Public Transparency and the Comptroller General of the Union, for compliance and anticorruption practices.
Can multiple government agencies simultaneously conduct an investigation of the same subject? Does a completed investigation bar another agency from investigating the same facts and circumstances?
The same fact or subject can be investigated by multiple agencies. In fact, recently government agencies have been increasing the integration between investigative and sanction activities (ie, cooperation agreements entered into by and between ANS and CADE, and by and between ANVISA and the US Food and Drug Administration to enhance activities of mutual interest of the parties).
Regulation of pharmaceutical products and medical devicesMonitoring powers
What powers do the authorities have to monitor compliance with the rules on drugs and devices?
Authorities have the following powers, among others, to monitor compliance:
- sites and facilities manufacturing process inspections;
- document requests;
- periodic reports; and
- monitoring of licences and registrations; among others.
Additionally, to verify compliance with the good practice standards, periodic inspections are undertaken by sanitary surveillance authorities.Investigation time frames
How long do investigations typically take from initiation to completion? How are investigations started?
The current regulation does not provide a formal deadline for health authorities to complete an investigation process. The length of the process varies on a case-by-case basis. At the administrative level, they may take a few months to a couple of years.
Investigations are often started by means of a complaint (typically a competitor or consumers) or as a result of authorities’ inspection activities.Access to investigation materials
What rights or access does the subject of an investigation have to the government investigation files and materials?
The Brazilian Constitution guarantees the rights to an adversary system and a full defence. Thus, the subject of an investigation should have full access to the investigation files and materials. However, this right may be restricted in cases where secrecy is required for the continuity of the investigation. In such cases, the subject of an investigation may not even be aware of an ongoing investigation.Investigations abroad
If pharmaceutical products or medical devices are made in a foreign country, may the authorities conduct investigations of the manufacturing processes in that other country?
Yes. ANVISA may conduct inspections in facilities located abroad as part of the approval and registration proceedings of pharmaceutical products or medical devices produced abroad. If the product or medical device complies with Brazilian sanitary regulation, ANVISA will issue a good manufacturing practice certificate.Enforcement proceedings
Through what proceedings do agencies enforce the rules?
Agencies enforce their rules by means of administrative proceedings, which are held by their own officials pursuant to the rules established by laws and additional regulation enacted by the agencies. Although agencies’ proceedings have an administrative nature, they may issue notices to federal or state prosecutors regarding potential civil and criminal offences. In these cases, federal or state prosecutors must apply to a court.
As a rule, administrative decisions can be reviewed by courts.Sanctions
What sanctions and other measures can the authorities impose or seek in enforcement actions against drug and device manufacturers and their distributors?
According to ANVISA’s regulations, companies that incur sanitary violations are subject to the following penalties:
- seizure of products;
- destruction of products;
- partial or total interdiction of facilities;
- cancellation of registration (marketing authorisation);
- suspension of sales or manufacturing of products;
- suspension of product advertising and publicity;
- issuance of public rectifying messages;
- prohibition on advertising;
- partial or total establishment closure;
- cancellation of the establishment’s licence;
- cancellation of the company’s operation authorisation; and
- imposition of fines ranging from 2,000 reais to 1.5 million reais, which are doubled in cases of repeated offences.
Additionally, state and municipal health authorities have specific legislation on sanctions and other measures that may be imposed against drug and device manufacturers and distributors. As rule, such authorities have similar provisions to ANVISA regulation on penalties.
In addition, some conduct is also defined as criminal, including crimes against public health, falsification, corruption, tampering or modification of therapeutic or medicinal products. As a result, ANVISA may report the possible wrongdoing to the Public Prosecutor’s Office and work along with other authorities to investigate possible crimes.
All sanctions and measures may vary according to the violation and the presence of mitigating and aggravating circumstances, and may be applied without prejudice to additional civil or criminal sanctions.Actions against employees
Can the authorities pursue actions against employees as well as the company itself?
As a rule, sanitary authorities pursue actions and apply penalties solely against companies.
However, employees may face civil liability before the company for actions and omissions that caused harm to the company. Furthermore, if authorities have evidence that a crime was committed, they are likely to pursue actions against the employees involved, especially considering that, except for environmental matters, there is no corporate criminal liability in Brazil.Defences and appeals
What defences and appeals are available to drug and device company defendants in an enforcement action?
In cases of enforcement actions issued by ANVISA or the Municipal VISA authority, drug or medical device companies can file an administrative defence before these authorities, opposing the non-compliance allegations and presenting new arguments to exclude or mitigate potential penalties. If the defence is not admitted or the decision is upheld, the company can appeal to the supervising body within the authority that issued the decision.
Notwithstanding, as a rule, administrative decisions can also be reviewed by judicial courts.Minimising exposure
What strategies should companies adopt to minimise their exposure to enforcement actions and reduce their liability once an enforcement action is under way?
To minimise regulatory risks and reduce liability, companies should comply with federal, state and municipal regulations. For ongoing enforcements, companies should refrain from practising any possible infractions and adopt measures to minimise eventual damages or risks already in effect. In addition, companies may also adopt internal regulatory compliance guidelines.Recent enforcement activities
What have the authorities focused on in their recent drugs and devices enforcement activity and what sanctions have been imposed?
The most relevant recurring claims are related to:
- supply of medicines that are not in accordance with safety and quality standards;
- importation and commercialisation of products not approved by ANVISA;
- operation of healthcare companies without the proper permits;
- false advertising;
- non-compliance with good manufacturing practices requirements; and
- violations of online sales regulation, especially those that require medical prescriptions.
The sanctions imposed are mainly fines, which vary on a case-by-case basis, depending on the nature of the violation, the amount of non-compliant products, if it is a repeat offence, among other circumstances.
In the case of sanitary risk, ANVISA may determine the interdiction or closure of the establishment.Self-governing bodies
Are there self-governing bodies for the companies that sell pharmaceutical products and medical devices? How do those organisations police members’ conduct?
There are several self-governing bodies for companies that sell pharmaceutical products and medical devices. The most relevant ones are the Pharmaceutical Research Industry Association, Association of High Technology Industry of Medical Devices, Pharmacy and Drugstore chains Association, Brazilian Pharmachemical Industry Association, and the Health-Ethics Institute.
To oversee members’ conduct, each association has its own guidelines or codes of ethics and conduct, which are binding on its members. In the case of non-compliance, companies are usually subject to the following penalties: warning, fines, membership suspension and debarment. Penalty applications varies according to the seriousness of the violation.
Relationships between healthcare professionals and suppliersRelationship rules
What are the rules prohibiting or controlling the financial relationships between healthcare professionals and suppliers of products and services?
The main regulations prohibiting or controlling the financial relationships between healthcare professionals and suppliers of products and services are as follows:
- ANVISA’s Resolution RDC No. 96/2008: establishes that the sponsorship for healthcare professionals or healthcare services shall not be subject to any prior prescription, dispensing or advertisement of any kind; it also provides that pharmaceutical companies must disclose any conflicts of interest with sponsored healthcare professionals or services;
- Codes of ethics or conduct of self-governing bodies: establishes that healthcare companies must pursue the relationship with professionals and other entities with transparency and in accordance with market good practices;
- Medical Code of Ethics enacted by the Federal Medical Council: provides that the medical profession’s services cannot be provided, by any means, for commercial purposes, nor can a physician’s services be exploited by third parties for commercial purposes. In addition, physicians are prohibited from receiving any sort of compensation or benefits from the referral or prescription of health-related products or services;
- Code of Ethical Conduct for Sitting Public Officials (Decree No. 4081/2002): limits gifts for federal governmental officials to the face value of 100,00 reais;
- Criminal Code: defines the crimes of active and passive bribery; and
- states and local regulations: general rules regarding the interactions between healthcare professionals and providers of health-related products and services.
How are the rules enforced?
See question 14.Reporting requirements
What are the reporting requirements on such financial relationships? Is the reported information publicly available?
Currently, there is no federal regulation on reporting requirements. However, there is a legislative trend to regulate and control transactions and financial interactions between healthcare professionals and providers of health-related products and services. In this regard, a bill of law is currently under discussion in the Brazilian Congress that provides for the requirement of transparency and disclosure of financial interactions in the healthcare sector.
Similarly, Minas Gerais State passed Law No. 22,440/2016, which provides for the compulsory disclosure by the medication, orthoses, prostheses, medical equipment and implants industries of interactions with healthcare professionals that may constitute a potential conflict of interest. A ‘conflict of interest’ is defined as any kind of gift or benefit, granted directly or through third parties to the healthcare professional enrolled in the applicable professional council within Minas Gerais State.
Regulation of healthcare deliveryAuthority powers
What powers do the authorities have to monitor compliance with the rules on delivery of healthcare?
Authorities have the following powers, among others, to monitor compliance with the rules on delivery of healthcare:
- document requests;
- periodic reports; and
- monitoring licences and registration, sites and facilities inspections.
How long do investigations of healthcare providers typically take from initiation to completion? How are investigations started?
See question 11.Access to investigation materials
What rights or access does the subject of an investigation have to the government investigation files and materials?
See question 12 .Enforcement agencies
Through what proceedings do agencies enforce the rules?
See question 14.Sanctions
What sanctions and other measures can the authorities impose or seek in enforcement actions against healthcare providers?
To guarantee the enforcement of actions against healthcare providers, the following sanctions and measures can be imposed, cumulatively or alternatively:
- cancellation of the company’s operation authorisation or a mandatory portfolio transfer or sale;
- suspension and revocation of the right to practise the profession;
- partial or total establishment closure; and
- cancellation of an establishment’s licence.
Healthcare service providers (clinics and hospitals) are also subject to state and municipal sanitary regulations.
In the case of an HMO’s non-compliance with ANS regulation, the regulatory authority and the HMO may execute a deed of commitment to adjustment of conduct, pursuant to which the HMO will refrain from non-compliant practices and rectify any damage that might have been caused therefrom.
All sanctions and measures may vary according to the violation and the presence of mitigating and aggravating circumstances, and may, be applied without prejudice to additional civil or criminal sanctions.Defences and appeals
What defences and appeals are available to healthcare providers in an enforcement action?
In an enforcement action due to non-compliance with healthcare regulation, healthcare providers can file an administrative defence before the authorities opposing the non-compliance allegations and presenting new arguments to exclude or minimise potential penalties. If the defence is not admitted or the decision is upheld, the company can appeal to the supervising body within the authority that issued the decision.
Administrative decisions can also be reviewed by judicial courts.Minimising exposure
What strategies should healthcare providers adopt to minimise their exposure to enforcement actions and reduce their liability once an enforcement action is under way?
See question 18.Recent enforcement activities
What have the authorities focused on in their recent enforcement activity and what sanctions have been imposed on healthcare providers?
The authorities have been focusing on the following claims:
- medical proceedings (clinical or surgical) not covered by the healthcare plan;
- exclusions of services providers from the contracted network;
- contracts’ annual readjustments; and
- the lack of proper licences or registers.
Usually, healthcare providers are sanctioned with fines and, in the case of major sanitary risk, authorities may revoke the facility’s licences or suspend the provision of the service or sale of products.Self-governing bodies
Are there self-governing bodies for healthcare providers? How do those organisations police members’ conduct?
There are several self-governing bodies for the healthcare providers, including the Brazilian Association of Group Medicine (ABRAMGE) and the Brazilian Association of Private Hospitals (ANAHP).
To oversee member’s conduct, each association has its own guidelines or codes of ethics and conduct, which are binding on its members. In case of non-compliance, the companies are usually subject to the following penalties:
- membership suspension; and
- membership exclusion.
Penalties applications varies according to the seriousness of the violation.Remedies for poor performance
What remedies for poor performance does the government typically include in its contracts with healthcare providers?
As a rule, contracts between healthcare providers and the government are preceded by a public bidding proceeding. Under public bidding rules, the government enjoys many prerogatives, such as the right to unilaterally terminate a contract in the event of poor performance by the company.
Furthermore, according to Law No. 8,666/93 (Public Procurement Act), companies that perform illegal acts or demonstrate a lack of good standing to enter into administrative agreements are subject to the following administrative penalties:
- temporary suspension to participate in public bidding and prohibition from entering into administrative agreements for up to two years; and
- declaration of lack of good standing to participate in bidding and enter into any administrative agreements (debarment).
In addition to the penalties addressed above, in the case of contractual default, the contracted entity is also subject to the imposition of warnings and fines.
Private enforcementCauses of action
What private causes of action may citizens or other private bodies bring to enforce a healthcare regulation or law?
The majority of causes of action relates to the access to drugs, medicines and medical procedures not covered by an HMO or SUS; followed by matters related to the elderly, which usually refer to the increase in the monthly amount charged by healthcare providers. According to recent case law, most cases provide a favourable decision to consumers (beneficiaries).Framework for claims
What is the framework for claims of clinical negligence against healthcare providers?
Brazilian law does not provide a definition of ‘standard of care’. In this sense, the conduct of healthcare providers is directed by regulations enacted by professional councils, such as the Federal Council of Medicine.
When an individual suffers any damage from the infringement of conduct that was expected to be respected by healthcare providers, it is possible to file a claim requesting the payment of moral and material damages. The success of a claim depends on the evidence that will be produced on the case, thus assessments can only be made on a case-by-case basis.
Regarding the penalties imposed on public or private healthcare providers, the law and courts’ positions are different. When a claim is filed against a private healthcare provider, Brazilian law sets forth a ‘fault-based liability’, which means that the plaintiff has to prove the misconduct of the healthcare provider and the success of this claim usually depends on the outcome of expert evidence.
In contrast, the public or quasi-public healthcare providers’ liability follows the Administrative Risk Theory, which means that the plaintiff does not have to prove misconduct. However, the courts have two different theories on this matter and sometimes exclude state liability. Whereas some courts consider the state ‘strictly liable’ under all circumstances, others classify the situation according to the conduct (ie, if it is related to a wrongdoing act practised by a healthcare provider it is ‘strictly liable’; if it is related to an omission it is ‘fault-based liable,’ which requires additional evidence to prove liability).
In all cases, damages can be material, moral, aesthetic or life-long pensions.Seeking recourse
How and on what grounds may purchasers or users of pharmaceuticals or devices seek recourse for regulatory and legal infringements?
In cases of non-compliance with Brazilian regulation, purchasers or users of pharmaceuticals or devices may file a claim before ANVISA or the courts. The claim can be based on the infringement of any requirement of the regulation. In addition, the purchaser or user of pharmaceuticals or devices may resort to contacting consumer associations or public prosecutor to report an infringement, and the legal actions can be taken by these institutions.Compensation
Are there any compensation schemes in place?
Brazilian law does not provide for compensation schemes. However, compensation schemes are not prevented by law and can be implemented pursuant to a judicial decision.Class and collective actions
Are class actions or other collective claims available in cases related to drugs, devices and provision of care?
Yes, class actions are available to protect collective rights (diffuse or homogenous) or interests, which includes healthcare (as it is a fundamental right provided by the Brazilian Constitution). Brazilian law sets forth that a class action can be brought by the public prosecutor, the federal government, states and municipalities, and the entities and bodies of the direct and indirect public administration and associations legally created for at least one year that include among their purposes the protection of the interests and rights of consumers.
When a class action is filed by an association, it is mandatory to have a written authorisation by its associates, and these associates will be the beneficiaries of the award. In addition, once the class action is considered acceptable, a public notice will be published to allow third parties to cooperate on the case. Depending on the nature of the dispute (ie, if it involves a diffuse or homogenous right), the award enforcement can be made by the individual or the claimant. The class action cannot discuss individual rights, which may be sought via a claim filed by a consumer itself.Review
Are acts, omissions or decisions of public and private institutions active in the healthcare sphere subject to judicial or administrative review following a complaint from interested parties?
Yes. Acts, omissions or decisions of public and private institutions regarding healthcare are subject to judicial review, throughout a claim that can be brought by individuals or associations. A lawsuit can be filed in the domicile of the interested party, in the place where the omission occurred or where the decision was issued.
A claim must be filed within five years of the day that the decision, act or omission become public.
A decision on the merits usually leads to the same claim being precluded for five to 10 years. The claim can be based on the infringement of rights (individual or collective) and an injunction can be requested to suspend the effects of the act, omission or decision.Whistleblowers
Are there any legal protections for whistleblowers?
There is no whistleblower protection provided by the sanitary and healthcare regulations. However, a Brazilian anti-corruption legislation has established a government-managed whistleblowing hotline for citizens to report crimes and administrative violations. The law sets forth that whistleblowers who use this hotline should have their identity protected, but does not contain specific protections. Note that further regulation on the Brazilian anti-corruption whistleblowing mechanisms is expected, and new protection mechanisms could be implemented.
Does the country have a reward mechanism for whistleblowers?
There is no reward mechanism for whistleblowers provided by sanitary and healthcare regulations. However, Brazilian anti-corruption legislation allowed federal, state and municipal authorities to create reward mechanisms for whistleblowers that assist with the prevention, repression or identification of crimes and administrative infractions, including cash payments and reduction of a sanction if the whistleblower’s good faith is proved. Note that further regulation on the Brazilian anti-corruption whistleblowing mechanisms should be expected, including with regard to its reward mechanisms.
Are mechanisms allowing whistleblowers to report infringements required?
In general, there are no mechanisms allowing whistleblowers to report infringements provided by the sanitary and healthcare regulations. However, Brazilian anti-corruption legislation considers that an effective anti-corruption compliance programme should include a whistleblowing channel with proper protection mechanisms, and certain publicly held companies with shares listed in the highest corporate governance segment of the B3 SA (Brasil, Bolsa, Balcão stock exchange) are also required to create whistleblowing channels and to protect whistleblowers against retaliation.
Cross-border enforcement and extraterritorialityCooperation with foreign counterparts
Do prosecutors and law enforcement authorities in your country cooperate with their foreign counterparts in healthcare cases?
Yes. Over the past few years, Brazilian enforcement authorities have executed several cooperation agreements with, and initiated or received several cooperation requests to or from, foreign counterparts for the investigation of fraud, corruption and other corporate misconducts including in the healthcare sector. Up to December 2018, for example, the Car Wash probe alone resulted in more than 300 requests for international cooperation with 36 different countries. Brazilian authorities have also played major roles in recent cross-border investigations that resulted in investigations or settlements under the Foreign Corrupt Practices Act involving large multinational companies, including US-based healthcare companies.Triggering investigations
In what circumstances will enforcement activities by foreign authorities trigger an investigation in your country?
Brazilian enforcement authorities will likely begin an investigation when foreign authorities require their cooperation or when the facts or subjects under investigation are within their jurisdictional reach.Pursuing foreign entities for infringement
In what circumstances will foreign companies and foreign nationals be pursued for infringements of your country’s healthcare laws?
Whenever foreign companies and foreign nationals infringe Brazilian healthcare laws, local authorities may pursue action against them. Nevertheless, in cases when the companies or the individuals are abroad, Brazilian authorities may face enforcement issues.
Update and trendsCurrent developments
What are the authorities’ enforcement priorities likely to be in the coming year? Are there any noteworthy cases pending? Are there any current developments or emerging policy or enforcement trends that should be noted?No updates at this time.