Categoria: English

  • Sale of Medicines on Marketplaces to Undergo Public Consultation

    Sale of Medicines on Marketplaces to Undergo Public Consultation

    The regulation of e-commerce in the healthcare sector will undergo new definitions. The regulatory agency has begun a process that will establish the rules for the sale of medicines on marketplaces, e-commerce platforms, and other digital channels.

    The role of the public consultation

    To define the new operating framework for digital platforms, the proposed rules will be submitted to a public consultation. This mechanism allows the market, technology companies, and civil society to follow the topic and understand the guidelines before their final approval.

    Impact on digital platforms

    The initiative seeks to establish parameters for the operation of digital channels that broker or conduct medicine sales. Defining these standards is a step aimed at aligning digital retail operations with healthcare sector oversight.

    Companies operating under the marketplace model should monitor the development of this public consultation to understand the future regulatory landscape applicable to their commercial operations.

    This content is for informational purposes only and does not constitute legal advice. For guidance on specific matters, consult a qualified lawyer.

  • The Oncoclínicas Case and Statutory Tender Offers (OPA) in the Capital Markets

    The Brazilian capital market frequently encounters situations that test governance rules and the dynamics among public company investors. Recently, the case involving Oncoclínicas has raised important discussions regarding corporate protection mechanisms and shareholder conduct.

    Statutory tender offers (OPA) and shareholder activism

    A statutory tender offer (OPA, or Oferta Pública de Aquisição) is a mechanism included in the bylaws of various companies to set specific rules in cases of relevant equity acquisitions. The Oncoclínicas episode highlights the role of this instrument amid growing shareholder activism in Brazil.

    Shareholder activism occurs when investors use their position on the shareholder roster to actively influence management decisions and strategic directions. When this movement intersects with OPA trigger thresholds set forth in corporate bylaws, the market closely watches how the company’s internal rules are interpreted and applied.

    The minority dilemma: protection versus convenience

    The central discussion raised by the case revolves around the role of minority shareholders. The debate contrasts two fundamental aspects of corporate relations:

    • Minority protection: The need to ensure that non-controlling shareholders are not harmed by control transactions or by decisions that concentrate power disproportionately.
    • Opportunistic convenience: The risk that mechanisms created to protect investors might be used strategically or opportunistically to force negotiations or extract specific advantages during transition periods.

    Finding the balance between the legitimate defense of minority rights and the prevention of opportunistic behavior remains a major challenge in modern corporate governance.

    Market perspectives

    Debates like this serve as a gauge for the capital markets, highlighting the importance of clear and objective drafting in corporate bylaws. For investors, executives, and founders, the episode reinforces that a thorough understanding of governance rules is essential for legal certainty and predictability in corporate relations.

    This content is for informational purposes only and does not constitute legal advice. For guidance on specific matters, consult a qualified lawyer.

  • AI Governance in Private Companies: Risks and Challenges

    AI Governance in Private Companies: Risks and Challenges

    Artificial intelligence (AI) has rapidly shifted from the experimentation phase to implementation across daily business operations. For fast-growing private companies, the technology offers substantial opportunities, such as increasing productivity, improving customer experience, and accelerating decision-making. However, accelerated adoption without adequate oversight creates significant vulnerabilities.

    Recent data indicates that nearly three out of four companies plan to implement agentic AI (systems capable of taking actions with limited human involvement) over the next two years. In contrast, only one in five possesses a mature governance model for autonomous agents. This gap exposes organizations to operational, legal, cybersecurity, and reputational challenges.

    The Mismatch Between Adoption and Governance

    AI is increasingly embedded in core business processes, with use cases including content generation, coding assistance, knowledge retrieval, data analysis, and customer support. It is observed that the greatest barriers to value creation are often organizational rather than technical. Companies reporting the most progress are those that align technology investments with employee training, establishing clear governance and defined expectations on how tools should be used across the entire organization.

    Key Artificial Intelligence Risks for Companies

    Effective AI governance begins with identifying where the technology can create risks. Key areas of concern include:

    • Data, Privacy, and Intellectual Property: AI tools process vast volumes of data. Without established controls, companies can lose visibility over how sensitive information circulates within their environments. This generates risks of unauthorized use, uncertainty over the ownership of AI-generated content, and difficulties in demonstrating compliance. The risk is compounded by shadow AI, which occurs when employees use unsanctioned tools that operate outside security controls.
    • Autonomous Actions and Agentic AI: The risk associated with autonomous agents goes beyond providing a “wrong answer” to executing a “wrong action.” For example, a chatbot at a car dealership in the United States was manipulated by a user into agreeing to sell a new vehicle for $1. This incident illustrates how tools can be pushed outside their intended scope when safeguards are weak.
    • Reliability and Performance: The performance of an AI model can drift over time due to updates, new data sources, and changes in the operating environment. Systems that are not continually monitored and re-evaluated can cause operational disruptions and poor decisions.
    • Customer Impact and Business Risk: When AI is integrated into customer-facing processes, the consequences of failure escalate. Errors or biases can translate into tangible harm. For instance, health insurers in the United States have faced lawsuits challenging the use of algorithmic tools in coverage denials, with allegations that automated systems contributed to improper determinations.
    • Vendor Dependency: Most companies build their operations using tools developed by third parties. This creates a reliance on external infrastructure and model providers, exposing the business to vulnerabilities within the AI supply chain.

    Practical Considerations

    To mitigate these risks, it is essential for companies to adopt best practices that build the trust and discipline required for the safe deployment of artificial intelligence. Structuring internal processes, defining the scope of tool operations, and maintaining continuous supervision are indispensable steps to protect the business against litigation and reputational harm.

    This content is for informational purposes only and does not constitute legal advice. For guidance on specific matters, consult a qualified lawyer.

  • Decree Regulates Brazil’s Power Market for 2027

    Decree Regulates Brazil’s Power Market for 2027

    The regulatory framework for the Brazilian infrastructure sector will undergo a significant transition in the coming years. A new decree was recently issued to regulate the opening of the country’s electricity market, establishing that the changes will take effect starting in 2027.

    The 2027 Milestone

    Setting 2027 as the milestone for market opening provides a crucial planning horizon for companies, power generators, and investors. The regulation via decree formalizes the guidelines that will steer this transition, establishing a clear path toward a more flexible contracting environment.

    Strategic Planning

    For corporate entities, executives, and foreign investors operating in the Brazilian infrastructure sector, early regulation enables the structuring of new business models. The timeframe leading up to 2027 provides the necessary runway for market participants to understand the new rules and adjust their operations and power supply contracts.

    Monitoring the implementation of this regulation will be essential for companies seeking to optimize operational costs and explore new opportunities in the power sector throughout this decade.

    This content is for informational purposes only and does not constitute legal advice. For guidance on specific matters, consult a qualified lawyer.

  • STF Sets New Parameters for Standalone Tax Penalties

    STF Sets New Parameters for Standalone Tax Penalties

    The STF (Brazil’s Supreme Federal Court) recently defined new parameters for the application of standalone tax penalties in Brazil. The development, reported by the legal news portal Consultor Jurídico, brings relevant implications for the business environment and the tax planning of domestic and foreign companies operating in the country.

    The concept of standalone tax penalties

    To understand the impact of the STF rulings, one must understand the nature of tax duties in Brazil. The tax system divides taxpayer responsibilities into two main categories:

    • Main obligations: Refer to the actual payment of the tax owed to the State.
    • Ancillary obligations: Consist of bureaucratic and reporting duties, such as filing tax returns, issuing electronic invoices, and maintaining accounting records.

    A standalone tax penalty is the sanction applied when an ancillary obligation is breached. It is termed “standalone” precisely because it is levied independently of whether any underlying tax is due. In other words, a company may be penalized for failing to submit a document within the statutory deadline, even if it has no overdue taxes.

    The role of the STF and constitutional limits

    The Supreme Federal Court acts as the guardian of the Brazilian Constitution. In tax matters, the court is frequently called upon to assess whether penalties imposed by tax authorities comply with constitutional principles, such as the prohibition of confiscatory taxation and the principle of proportionality.

    When the STF establishes new parameters for standalone penalties, the court sets clear boundaries on how much the State may charge for administrative non-compliance. Historically, the legal debate has centered on preventing penalties for ancillary non-compliance from reaching disproportionate amounts that could jeopardize the financial viability of companies, especially within Brazil’s complex tax environment.

    Relevance for investors and executives

    For founders, executives, and foreign investors, the definition of parameters by the STF serves as a key indicator for corporate governance. Legal predictability is a core pillar for attracting and retaining investment in Brazil, particularly in cross-border transactions.

    Clarity regarding the limits of tax penalties enables companies to make more accurate financial provisions and structure their compliance departments based on rules consolidated by the country’s highest court. Furthermore, decisions of this nature guide lower courts and administrative tax appeal boards, standardizing the application of the law across the national territory.

    Practical takeaway

    The establishment of parameters for standalone tax penalties by the STF reinforces the need for companies to maintain rigorous oversight of their tax compliance routines. While setting limits provides greater legal certainty against state punitive actions, strict compliance with ancillary obligations remains the most effective measure to mitigate risks and prevent unwanted tax liabilities.

    This content is for informational purposes only and does not constitute legal advice. For guidance on specific matters, consult a qualified lawyer.

  • Deadline to Update the Salary Transparency Report

    Private companies with 100 or more employees have until August 31 to update their information with the MTE (Brazil’s Ministry of Labor and Employment). The submitted data will be used to draft the 6th Salary Transparency and Remuneration Criteria Report, an official document published biannually by the federal agency.

    Procedure and Required Information

    Submitting this information is a legal requirement and must be performed directly within the employer section of the Emprega Brasil Portal. To access the system and update the data, managers must log in via the Gov.br platform.

    During this update cycle, companies must provide details regarding:

    • Remuneration criteria adopted across the organization;
    • Internal initiatives aimed at promoting diversity;
    • Programs supporting families and parenting.

    Companies with 100 or more employees that fail to submit the required reporting data twice a year will face administrative penalties.

    Context of the Equal Pay Law

    The requirement for biannual reporting stems from the Equal Pay Law (Federal Law No. 14,611/2023). The statute mandates equal compensation for men and women performing work of equal value or fulfilling identical job functions.

    The impact of this legal standard is monitored by the MTE. According to the 5th Salary Transparency and Remuneration Criteria Report, released in late April based on records from 53,000 companies, women in the Brazilian private sector earn an average of 21.3% less than men.

    The legislation establishes that whenever wage disparities are identified in the reports, companies must draft an action plan to mitigate them. This internal compliance document must define clear targets and timelines to correct remuneration gaps.

    Constitutional Validation by the STF

    The enforceability of the salary transparency framework was affirmed by the judiciary. In May of this year, the plenary bench of the STF (Brazil’s Supreme Federal Court) validated the statutory provisions and upheld the law as constitutional.

    The ruling concluded legal challenges brought by representative industry entities. The National Confederation of Industry (CNI) and the National Confederation of Commerce of Goods, Services, and Tourism (CNC) filed Direct Action of Unconstitutionality (ADI) 7612, while the Novo Party filed ADI 7631. In contrast, Declaratory Action of Constitutionality (ADC) 92 was initiated by labor unions, including the Central Única dos Trabalhadores (CUT) alongside metalworker and textile confederations.

    Practical Considerations

    Meeting the August 31 deadline requires executive boards and human resources teams to organize compensation structures and diversity policy records. Uploading the data via the Emprega Brasil Portal is the necessary procedure to ensure compliance with the Equal Pay Law and avoid sanctions from the Ministry of Labor and Employment.

    This content is for informational purposes only and does not constitute legal advice. For guidance on specific matters, consult a qualified lawyer.

  • Digital Platforms and Systemic Risk Management

    Digital Platforms and Systemic Risk Management

    The debate surrounding regulation and the role of new technologies in Brazil points to a significant transformation in how digital platforms are held liable. Set within the context of the digital economy, this shift proposes a new architecture for content moderation and structural harm mitigation.

    From Individual Takedowns to a New Architecture

    Until recently, discussions on internet content moderation relied primarily on individual removals. Under this model, platforms operated reactively, taking down specific posts or information only after receiving notice of potential infractions.

    However, current analyses of the digital economy indicate a transition toward a model focused on systemic risk management. This new liability framework requires digital platforms to adopt a broader, preventive approach, establishing mechanisms capable of addressing the systemic impact of their operations rather than focusing solely on isolated incidents.

    The Impact on the Digital Economy

    For investors, founders, and executives of technology companies operating in Brazil, this conceptual shift signals an evolving regulatory environment. Systemic risk management means companies must design internal policies that do not merely react to specific reports, but actively assess the structural risks inherent to their own services.

    Practical Considerations

    • Structural prevention: Compliance now demands a broader evaluation of how platforms function systemically, moving beyond case-by-case moderation.
    • Continuous adaptation: Digital sector companies should closely monitor this evolution to align their operations with the emerging liability standards in the Brazilian market.

    This content is for informational purposes only and does not constitute legal advice. For guidance on specific matters, consult a qualified lawyer.

  • STJ Rules That ICMS-Difal Is Excluded from PIS and Cofins Calculation Bases

    STJ Rules That ICMS-Difal Is Excluded from PIS and Cofins Calculation Bases

    The Superior Court of Justice (STJ, Brazil’s highest appellate court for non-constitutional federal matters) established that the Rate Differential of the State Value-Added Tax (ICMS-Difal) does not compose the calculation base for PIS and Cofins federal contributions.

    What does this decision mean?

    To understand the impact of the ruling, it is important to clearly clarify the key concepts involved:

    • ICMS-Difal: The rate differential of the state value-added tax levied on interstate transactions. Its purpose is to balance tax revenue between the state of origin and the state of destination of goods.
    • PIS and Cofins: Federal social contributions levied on gross corporate revenues or turnover.

    The core issue analyzed by the court was whether the amount paid as ICMS-Difal could be considered part of a company’s gross revenue for the purposes of calculating PIS and Cofins. By ruling that the state tax does not compose this base, the STJ excludes this amount from the calculation of these federal contributions.

    Impact on businesses

    Excluding ICMS-Difal from the PIS and Cofins calculation base represents a key milestone for the tax operations of companies engaged in interstate sales. The understanding directly affects sectors with a high volume of interstate transactions, such as retail and e-commerce.

    With this precedent set by the STJ, organizations gain greater clarity and legal certainty regarding how to calculate their federal tax liabilities in transactions that require payment of the rate differential.

    This content is for informational purposes only and does not constitute legal advice. For guidance on specific matters, consult a qualified lawyer.

  • Federal Government to Discuss Brazilian Cloud Initiative with the Market

    Federal Government to Discuss Brazilian Cloud Initiative with the Market

    The Brazilian Cloud Project

    The Brazilian federal government plans to initiate discussions with the market regarding the creation of the so-called Brazilian Cloud. The initiative’s primary focus is the development of infrastructure dedicated to data storage and processing in the country.

    Public-Private Partnership Model

    To enable the project, the proposal outlines a partnership between the public and private sectors. This collaborative model aims to combine the resources and technical expertise of technology companies with the needs of public administration.

    Developing data storage and processing infrastructure through this partnership signals a move to structure national technological capabilities with direct private-sector support.

    Market Dialogue

    Inviting companies to the discussions marks an initial alignment phase. The dialogue with the market will serve to examine parameters and assess the feasibility of building this new data infrastructure.

    This content is for informational purposes only and does not constitute legal advice. For guidance on specific matters, consult a qualified lawyer.

  • Governance and compliance: the case of the former CFO ordered to reimburse

    Governance and compliance: the case of the former CFO ordered to reimburse

    Integrity in corporate relations and transparency in procurement are core pillars of governance. Recently, a case in the Brazilian financial market illustrated the legal and financial consequences when these principles are breached. The Brazilian courts ordered the former CFO of Itaú, Alexsandro Broedel, to pay BRL 2.83 million to the financial institution.

    The core of the dispute: procurement and fee transfers

    The legal controversy revolves around senior executives hiring third-party services. According to the bank’s accusation, the former CFO allegedly received back 40% of the amount the institution paid to a consultant. The critical aspect of the case is that this consultant was hired by the executive himself.

    Situations where an officer or director receives direct or indirect financial benefits from suppliers they selected represent a serious conflict of interest. Under corporate law, executives are expected to make decisions based solely on the company’s best interests, without personal interests interfering in the selection of business partners or fee negotiations.

    Corporate governance and risk mitigation

    The episode highlights the importance of rigorous internal controls. When a company permits executives to hire consultancies, it is essential to have vetting processes and cross-approvals. This means the decision to hire and the monitoring of disbursements should not be concentrated in a single individual, regardless of their seniority in the corporate hierarchy.

    A company’s ability to detect irregularities, such as the alleged 40% kickback from consultant fees to the executive, demonstrates the need for ongoing audits and effective whistleblowing channels. Holding former officers liable for acts committed during their tenure is a direct reflection of the maturing compliance practices in the market.

    Practical takeaways for businesses

    For founders, investors, and board members, the case serves as a warning regarding vendor management. It is advisable to establish clear policies requiring conflict-of-interest declarations prior to any significant engagement. Furthermore, segregation of duties—where the person approving the need for a service is not the sole authority approving payment—acts as a preventive barrier against misconduct.

    This content is for informational purposes only and does not constitute legal advice. For guidance on specific matters, consult a qualified lawyer.