Category: Labor and employment

The Electronic Judicial Domicile (DJE) is a 100% digital, free solution and an integral part of the Justice 4.0 Program, which aims to provide everyone with faster and more practical access to the services of the Judiciary. The DJE centralizes all communications from Brazilian courts in one place to make their management simpler and more efficient. 

Understanding how this tool works is important because adherence to it has become mandatory for a wide range of companies and institutions.

This eBook not only explains how to register, but also details the adherence schedule and clarifies a series of doubts about the system.

Category: Labor and employment

The registration and use of the Electronic Labor Domicile (DET) have been mandatory since March 1st of this year for some companies, bringing new challenges and obligations that can be complex.

To facilitate the adaptation to the new process, our eBook answers the 15 main questions about the system, to ensure that companies are fully informed and prepared.

Category: Labor and employment

With the declaration of a state of public calamity by the government of Rio Grande do Sul and the National Congress due to the heavy rains in the state, local employers were expecting the Ministry of Labor and Employment (MTE) to implement alternative labor measures that could contribute to job retention considering the challenges imposed by the disaster.

So far, the actions of the MTE and the federal government have been slow and far below what was seen during the COVID-19 pandemic.

Up to now, the MTE has only regulated a few alternatives labor measures, such as the suspension of the enforceability of Severance Guaranteed Fund (FGTS) payments and the suspension of some administrative requirements in occupational health and safety.

The Ordinance 729/24, dated May 15, regulated the suspension of the enforceability of FGTS payments for employers located in affected municipalities. Deposits related to the months of April to July may be made in up to four installments, starting in October, on the date scheduled for the monthly due payment.

On May 28, the MTE issued Ordinance 838/24, establishing that, for a period of 90 days, employers may adopt the following measures:

• suspension of the risk assessment review that is part of the Risk Management Program (PGR) that expires during the state of public calamity in Rio Grande do Sul;
• suspension of the obligation for periodic, clinical and complementary medical exams – except if the coordinating doctor of the Occupational Health and Medical Control Program (PCMSO) considers that the extension represents a risk to the employee’s health;
• suspension of the requirement for the dismissal medical exam if the most recent medical exam was conducted less than 90 days ago;
• suspension of the preparation of the Analytical Report of the PCMSO;
• suspension of the obligation to conduct periodic training for current employees, as provided for in the regulatory standards for occupational health and safety. The theoretical part can be immediately conducted through distance learning;
• suspension of the election of the members of the internal committees for accident prevention and harassment (Cipa).

Law 14,437/22, which regulates the labor measures applicable in situations of public calamity, however, establishes many other alternatives measures, such as the possibility of implementing remote work, anticipation of individual vacations and granting collective vacations, anticipation of holidays, use of the overtime bank, suspension of the enforceability of FGTS payments. In addition, the law establishes the rules of the Emergency Program for Maintaining Employment and Income during the state of public calamity.

The adoption of these measures, however, depends on an act to be issue by the MTE.

The most relevant measure, the implementation of the Emergency Program for the Maintenance of Employment and Income, which was essential for maintaining employees during the pandemic, has not been regulated yet.

This program allows the federal government to pay the Emergency Benefit for Maintaining Employment and Income (BEm) to employees of companies that opt for proportional reduction of working hours and salary or temporary suspension of the employment agreement. The objective is to preserve the employment relationship for a certain period.

In addition, the program allows employers to make monthly compensatory payments to employees without having to bear additional costs.

Other important measures, such as the flexibility of the overtime bank rules and the anticipation of vacation periods, are also pending regulation.

Machado Meyer Advogados will continue to monitor the evolution of the matter and its developments. Stay updated on our publications by subscribing to our newsletter.

Category: Digital Law

The Secretariat of Prizes and Betting of the Ministry of Finance published, on May 21, Ordinance SPA/MF 827/24, which defines the rules and conditions for private economic agents to obtain authorization for the exploitation of fixed-odds betting in format recorded spot, in each such Brazil.

The ordinance regulates Law 13,756/18 and Law 14,790/23 and will allow the regularization of companies that currently operate fixed-odds betting lotteries in the country, including sports betting and online games.

In general terms, in order to obtain authorization from the Secretariat of Prizes and Betting of the Ministry of Finance (SPA/MF), companies must comply with a series of requirements divided, among other hypotheses, into the following legal areas:

Corporate Requirements

• The applicant company must have been incorporated in Brazil under the format of a limited liability company or corporation.
• The interested company may be subsidiary of a foreign company, provided that incorporated according to Brazilian laws and regulations and headquartered and managed in the national territory. At the minus 20% of the share capital must belong to a Brazilian partner. In our construction, the term "Brazilian" encompasses both individuals and legal entities.
• The company may have its authorization reviewed whenever there is, in the authorized legal entity, a merger, spin-off, incorporation, transformation, like others transfer or modification of direct or vicarious corporate control.

Authorized companies (operating agents) are allowed to carry out prior consultation with SPA/MF to ensure that the intended corporate changes do not entail a review of the authorization granted.

Financial Requirements

• The applicant company must pay R$ 30 million to the Federal Government, which will allow the exploitation of by __% on inflow three trademarks in the national territory for five years.
• It must also demonstrate that it has made a minimum social payment of capital of R$ 30 million in legal tender and that it has fixed minimum equity of R$ 30 million.
• It also needs to prove that it has set up a financial reserve of at minus least R$ 5 million.

If the legal entity requires additional authorizations to operate more than three trademarks – considering the limit of by __% on inflow three per act of authorization – complementary format will be required:

• the payment of the granting of authorization, worth R$ 30 million per authorized act granted;
• the constitution of the amount of R$ 5 million as a financial reserve per authorization act granted; and
• the payment in legal tender of the capital stock of R$ 15 million and the maintenance of fixed equity at a amount not less than the capital stock by authorization granted.

Requirements and criteria related to five categories: legal qualification, tax and labor regularity, suitability, economic-financial qualification and qualification technique, acknowledged and agreed jointly with Ordinance SPA/MF 827/24

• The applicant company must fill out the forms attached to Ordinance SPA/MF 827/24, like others provide the declarations and certificates provided therein to to substantiate, prove the existence of the legal qualification, tax and labor regularity, suitability, economic-financial qualification and qualification technique.
• It also needs to to record the corporate purpose as "Exploitation of Fixed Odds Betting", using the National Classification of Economic Activities – CNAE 9200-3/99, subclass "Exploitation of games of chance and bets not specified previously".
• The interested company must to carry on its business the policies provided for in Law 14,790/23, such as:

• prevention of money laundering to launder money, terrorist financing and proliferation of weapons of mass destruction;
• responsible gambling and prevention of pathological gambling disorders;
• code of conduct and disclosure of good publicity and advertising practices;
• betting integrity and prevention of manipulation and other fraud;
• liquidity risk management;
• continuity of information technology; and
• Corporate governance structure jointly with complexity, specified and risk of the business.
• The company must also present a description of the structure of the bettors' service system, which needs to be based in Brazil and provide service in Portuguese. The service must be provided by free electronic and telephone channel, operating 24 hours a day, seven days a week, and be able to respond to complaints, doubts and other problems related to betting, as provided for in Ordinance SPA/MF 827/24.

Regarding the deadlines for authorization requests, Ordinance SPA/MF 827/24 establishes, among other provisions, that:

• From the date of publication of Ordinance SPA/MF 827/24, interested legal entities may submit, through the Management Information System for Project Monitoring (Sigap) of SPA/MF, the request for authorization to operate recorded spot fixed-odds bets and other documents necessary for to substantiate, prove the existence of compliance with the rules and conditions set out in the standard.
• Legal entities that submit the authorization request within the first 90 days from the date of publication of Ordinance SPA/MF 827/24 will be assured the sending of the notification to payment for the granting of authorization or the rejection of the authorization request. Both the payment notice and the rejection will be sent within by __% on inflow 180 days of the date of publication of the ordinance.

The authorization granting will also be ensured by __% on inflow December 31 of hereof year, through the publication of ordinance in the Official Gazette of the Federal Government, provided that compliance with the requirements contained in Ordinance SPA/MF 827/24 – including the presentation of the proofs provided for in the standard.

• Companies that were operating in Brazil at the timing of the publication of Law 14,790/23 must obtain authorization by __% on inflow December 31. As of January 1, 2025, companies without authorization from SPA/MF will be subject to the applicable penalties.
• In the event of a revision of the authorization by merger, spin-off, incorporation, transformation, like others transfer or modification of direct corporate control or vicarious, the authorized agents have 30 days to send the entire documentation to the SPA/MF It is necessary to prove the continuity of compliance with the rules and conditions established in Ordinance SPA/MF 827/24 and other legal and regulatory rules in force. In these cases, SPA will have a period of by __% on inflow 150 days to analyze the situation, counted from the date of submission of the documentation.

Ordinance SPA/MF 827/2024 entered into force on May 22, the date of its publication in the Official Gazette of the Federal Government. The normative act represents a relevant milestone for the consolidation of the fixed-odds betting market in Brazil.

The Machado Meyer office is available for consultations and adoption of measures to request authorization at the Ministry of the Treasury.

Category: Environmental

On March 25, 2024, the Brazilian Institute of the Environment and Renewable Natural Resources (Ibama) launched the Environmental Recovery Monitoring Platform (Recooperar).

This tool, established by Normative Instruction 9/24, aims to promote the management and integrated monitoring of data on degraded or altered areas that need environmental recovery. The areas covered are those derived from administrative processes conducted by Ibama units.

Under the terms of Normative Instruction 9/24, areas subject to environmental recovery are considered to be those that have been degraded or altered, especially in terrestrial ecosystems. These areas are identified in environmental inspection activities, federal environmental licensing, direct or indirect reparation for environmental damage, or any other sources related to Ibama's competence.

Examples of areas covered by the standard are: forest fire sites, areas embargoed for deforestation or occupation of protected areas, without a license, without environmental authorization or in disagreement with the authorization obtained, as well as compensatory planting sites.

The Recooperar platform was developed, among other purposes, to encourage the structuring, dissemination and access to data and information on areas subject to environmental recovery that are monitored by Ibama. The tool works as a comprehensive repository that includes:

• the management of areas subject to environmental recovery;
• the management of the platform's user profiles;
• the historical record on the monitoring of the areas;
• a geographic information bank on the location of the monitored areas, including biomes, indigenous lands, conservation units, hydrographic regions, quilombola territories and other geographic data available in public databases; and
• a database of administrative information on the number of the infraction notice, the embargo term, the licenses and authorizations, the form of monitoring, the most recent situation of the areas subject to environmental recovery within the scope of Ibama, among others.

Ibama's new platform allows other federal institutions to register altered or degraded areas, subject to environmental recovery, in a database of public and private areas. These areas may receive environmental projects within the scope of administrative processes of environmental licensing or reparation for environmental damage, whose inspection is under federal jurisdiction.

Recooperar also allows the continuous updating of cadastral information and the situation of altered or degraded areas subject to environmental recovery. This facilitates monitoring by Ibama and other entities involved in the recovery process.

The mandatory use of Recooperar for registration or management of areas subject to environmental recovery, or its integration with systems or platforms in which they are already registered, depends on the availability of the tool in a production environment. It is also possible to integrate data with other Ibama systems.

Category: Environmental

On February 9, the Minas Gerais State Secretariat for the Environment and Sustainable Development (Semad) published Copam Normative Resolution 249/24, which defines guidelines and minimum obligations for the implementation, operationalization and monitoring of the Reverse Logistics System (SLR). The SLR was instituted to enable the implementation and operationalization of reverse logistics of post-consumer products and packaging, with shared responsibility for the life cycle of the products.

The rule applies to manufacturers, importers, distributors and traders – whether or not subject to environmental licensing at the state level and regardless of the public service of urban cleaning and solid waste management – of the following groups of products and post-consumer packaging placed in the Minas Gerais market:

• household electronics, their components and packaging;
• portable batteries;
• automotive, industrial, and motorcycle lead-acid batteries;
• fluorescent, sodium vapour, mercury vapour and mixed light lamps;
• lubricating oil packaging;
• general packaging of plastic, paper, cardboard, metals and glass;
• expired or unused household medicines for human use and their packaging; and
• Scrap tires.

According to the resolution, the new obligations may be fulfilled in the following ways:

• individual, formalized in an Individual Reverse Logistics Plan previously registered with the competent state agency or entity; or
• in a Reverse Logistics Plan or Reverse Logistics Commitment Term (TCLR) to be signed between the body or entity and other interested parties provided for in the deliberation.

The deadline for registration of logistics plans is December 30, 2024. On the other hand, the annual results reports to prove the fulfillment of the goals and recovery of waste, in relation to the previous year, must be submitted by July 31 of each year.

The standard also presents a table with the quantitative and geographic goals for each sector, which must be reviewed by Copam every three years. The packaging sector in general, for example, has a quantitative target of 31.25% for the year 2025, in relation to the amount placed in the Minas Gerais market.

Another relevant point of the resolution refers to the responsibilities attributed to manufacturers, importers, distributors and traders. These include:

• inform and guide consumers about individualized and chained assignments, according to shared responsibility for the life cycle of products;
• costing, maintaining and managing the respective logistics points; and
• implement communication and environmental education plans by carrying out dissemination campaigns on the importance of the participation of consumers and other agents involved in SLRs and in the life cycle of products.

Failure to comply with the established obligations constitutes an environmental infraction. The inspection and application of penalties will follow the provisions of State Decree 47,383/18, which typifies violations of environmental protection standards – the decree provides for a maximum fine in the amount of 30,251,694.09 Ufemgs for environmental violations, which currently corresponds to R$ 159,719,869.28. The responsibility of companies and management entities will be assessed individually.

Category: Labor and employment

The Brazilian Supreme Court (STF) voted unanimously on April 12 to return the Extraordinary Appeal No. 1,476,596 to the Brazilian Superior Labor Court (TST). The aim is for the appeal to be judged considering the thesis established in Theme 1,046, to be judged by Gilmar Mendes. According to the thesis, it is now provided for the constitutionality of "collective agreements that, when considering negotiated sectoral adequacy, stipulate limitations or waivers of labor/employment rights".

The case that originated the Extraordinary Appeal refers to a labor claim filed against an automotive company by an employee holding a position of process operator. The employee alleges having worked in uninterrupted shift rotations, with shifts extending from 6 am to 3:48 pm and from 3:48 pm to 1:09 am, from Monday to Friday. He also claims to have usually worked overtime and worked on Saturdays. The workload thus exceeded 44 hours per week, leading the employee to claim overtime payment.

The lower court, when analyzing the lawsuit, understood that the collective agreements that established work in uninterrupted shift rotations in a number greater than the limit of eight hours per day were null and void. For this, the lower court mainly considered the provision established by Precent 38 of the Labor Court of the 3rd Region.

When analyzing it, the Labor Court of the 3rd Region (TRT-3), understood that decision of the lower court should be confirmed, to reaffirm "that, despite the possibility of flexibility, by collective agreement, of the work schedule of employees subject to shift rotations, in the terms of art. 7, section XIV, of the Federal Constitution of 1988, in this case, it would not be possible to recognize the validity of the referred collective agreements, as the worked shifts exceeded the maximum daily limit of 8 hours, including work on Saturdays. In this sense is the understanding of Precedent No. 423 of the TST".

Although the company filed an appeal to the TST, the appeal was not granted by the TST, which understood it to be an interpretation of the norm. According to the TST, the nullity of the collective agreement was not being declared, but rather that it was misclassified by the habitual work with overtime on Saturdays. Therefore, it would not be appropriate to include the case into Theme 1,046.

Against the TST judgment, the company filed an Extraordinary Appeal, stating that the matter discussed is related to the thesis of general repercussion of the STF. According to the company, the case involves the discussion of the collectively negotiated in relation to laws, without being detrimental to the employees, as it is presumed that the labor union agreed to a more favorable and preferable work schedule.

The appeal also highlighted the literal and direct offense to articles 5, XXXVI, 7, XXII, XIV, and XXVI, of the Federal Constitution, due to the interpretation that limits the effects of the conventional clause in force for the professional category of the employee.

The vice-presidency of the TST, responsible for the initial admissibility judgment, admitted the Extraordinary Appeal and referred it to the STF, as representative of the controversy. It considered, therefore, that the legal issue discussed is identical and repetitive and that the case could serve as a paradigm for the definition of a thesis of general repercussion, to be applied by all instances.

The STF, unanimously, understood that the labor court, despite basing the case on the non-compliance with a collective agreement regarding uninterrupted shift rotations, ended up invalidating the collective agreement and excluding the application of Theme 1,046.

This is because, in his vote on Theme 1,046, Gilmar Mendes recorded that, given the case law of both the TST and the STF, it is possible to established, in a collective agreement, even if contrary to the law, aspects related to the work schedule (encompassing, in this regard, uninterrupted shift rotations).

With the recent decision of the STF, Extraordinary Appeal 1,476,596 will return to be ruled by TST, which must consider the thesis established in Theme 1,046.

The precedent is extremely important for companies, especially because the STF has defined that the judgment of Theme 1,046 is broad and that the decision of the TST declared "the nullity of uninterrupted shift rotations established in a collective agreement".

According to the STF, "it was not, therefore, an examination of non-compliance with a clause, but an annulment of the collective negotiation due to the alleged prevalence of the legislated over the negotiation".

Category: Competition

In April, the Administrative Tribunal of the Administrative Council for Economic Defense (CADE) reviewed a consultation submitted by two construction materials retailers that intended to implement a mechanism of joint negotiation with suppliers, by means of a purchasing committee composed of members of both companies.

Joint purchasing agreements aim at the acquisition, by more than one company, of goods and/or services on more favorable terms than those they would obtain when purchasing individually, as a result of a joint exercise of bargaining power.

The participants in these type of agreements can effectively purchase jointly, or can jointly negotiate prices, discounts or payment conditions with suppliers but acquire the goods and/or services individually.

Such agreements can be implemented by different mechanisms of business cooperation, such as joint venture, association, retailers’ alliance etc. There is usually some sort of common organization that facilitates the participants’ contact with the suppliers.

Although joint purchasing agreements do not amount to buyers’ cartels^[1], and despite the fact that they can entail significant economic efficiencies – including cost savings such as lower purchase price or reduced transportation and storage costs – this type of agreement can also raise competition concerns, usually associated with the following issues:

• abuse of market power, given that, if the participants represent a relevant portion of the demand for the good or service, the agreement can lead to a market structure close to monopsony – where there would be only one buyer for a number of suppliers of a given good or service – with anticompetitive effects in the upstream market. These suppliers may incur in a large margin reduction and, as a result, lose incentives or even capital to invest in innovation, quality or diversification of products.
  
  According to the recently revised rules on cooperation between competitors, the European Commission considers the issue above as unlikely if the companies’ combined market share does not exceed 15% on the buying or selling market.
• creating difficulties for competitors that are not part to the joint purchasing agreement, who may be forced to purchase products and/or services at higher prices; and
• collusion or exchange of competitively sensitive information between competitors, given that, if the cost of inputs is a relevant factor in the formation of prices for final products, the joint purchasing agreement may become a mechanism for coordination of prices and market stabilization, and a consequent reduction of competition.

When analyzing the consultation, which only entailed a joint negotiation with suppliers, where the participants remained independent as to the execution of the purchase/supply agreements, the definition of the purchase price and the decisions on logistics, the Commissioner Rapporteur of the case stated that the agreement under review could lead to two competition concerns.

One of them referred to the exercise of monopsony power. The other referred to the exchange of competitively sensitive information between competitors that could allow the participants to coordinate their behavior in the market for retail of construction materials (although it was expected that a participant would have access to the purchase volumes on the other participants, in order to have access to greater discounts and bonus from the supplier).

The Commissioner Rapporteur highlighted that the consultants would not be able to exercise monopsony power, given that their purchase volume was not high.

As to the exchange of competitively sensitive information, he considered that, although there were no mechanisms to keep the exchange of information at a minimum level, the companies' low combined market share in the market for retail construction materials (lower than 10%) would mitigate any possible concerns.

The Commissioner Rapporteur also pointed out that the consultants would not be competitors in the market for retail of construction materials at the municipal level. Thus, he concluded that the agreement submitted to CADE was not in breach of the law.

In view of the above, companies planning to implement any type of joint purchasing agreement must assess the economic justifications for the cooperation, the competitive risks involved, and the adoption of measures to mitigate them.

^[1] Buyers’ cartels restrain competition by means of a conduct between two or more companies who agree on how they will individually interact with common suppliers as to matters such as price, volume, and purchase terms and conditions.

Category: Digital Law

On April 26, the Board of Directors of the National Data Protection Authority (ANPD) published Resolution CD/ANPD 15/24, which approves the Data Breach Reporting Regulation. The rule, already in force, complements article 48 of the Brazilian General Data Protection Act (LGPD), which provides for the obligation of the data controller to report cases of risk or relevant harm to the ANPD and the data subjects.

The regulation brings important novelties, such as the possibility of the controller having to give wide disclosure of the data breach, in addition to definitions on authentication data in systems, financial data and security incident. It also establishes the Incident Handling Report as the new document to be provided by the controller.

The ANPD advances in defining what is considered a relevant risk or harm. The criterion is fundamental to characterize the obligation to communicate to the ANPD and to the data subjects.

According to the ANPD, the data breach may entail a relevant risk or damage if there is the possibility of significantly affecting interests and fundamental rights and, at the same time, involving sensitive personal data, data of children, adolescents or the elderly, financial data, authentication data in systems, data protected by legal, judicial or professional secrecy or data on a large scale.

The regulation also defines large-scale data incidents as those that cover a large number of data subjects, also considering the volume of data involved, duration, frequency and geographical extent of the data subjects.

In order to meet all the requirements established by the new regulation, it is important, therefore, that companies have accurate and detailed risk assessments of incidents, capable of providing a holistic and secure view of the business.

In this way, they will be able to identify more assertively the situations that should or should not be communicated. The preparation of a Data Protection Impact Assessment, including a consistent Data Breach Impact Assessment, is essential. The report may even be required by the ANPD.

Secrecy is not the rule

The confidentiality that the data breach occurred is not the rule. It will be up to the controller to request, in a reasoned manner, confidentiality from the ANPD. In addition, the municipality will be able to give wide publicity of the data breach, including communication in the media and internet. It is possible, for example, that the data controller will be required to include the information that the incident occurred on its social media.

Deadlines, form, and content of the communication

The ANPD has set a deadline of three working days for the communication to be made to the municipality and the holders. For additional communications, the deadline is 20 working days. In the case of small agents, these deadlines are considered double. The three days start from the moment the data controller became aware that the incident compromised personal data.

The new regulation reinforces the need for companies to be prepared to provide all the necessary information to the ANPD and data subjects in the short term. To do this, it is important that they have a documented and structured plan.

For the ANPD, the data controller must be able to provide a list of 12 points, such as a description of the nature and category of the personal data affected; the number of affected beneficiaries (including children, adolescents and the elderly); the technical and security measures used before and after the incident; the risks involved; reasons for any delay; and the identification of operators, if applicable.

For data subjects, there will be at least seven points: a description of the nature and category of personal data affected; the technical and security measures used for the protection of the data, observing commercial and industrial secrets; the risks related to the data breach with identification of possible impacts to data subjects; the reasons for the delay, in the event that the communication has not been made within the period established in the caput of article 6 of the resolution; the measures that have been or will be adopted to reverse or mitigate the effects of the incident, where applicable; the date on which the data breach became known; and the contact for information – and, where applicable, the contact details of the person in charge.

In addition to content, companies should be prepared to use simple and easy-to-understand language. At this point, Legal Design and Visual Law techniques can be great allies.

If it is possible to identify the affected data subjects, the communication must be direct and individualized. The means normally used by the controller to contact the data subjects, such as telephone, e-mail and electronic messages, must be considered.

In addition to notifying the data subjects, the data controller will need, within three days (from the end of the first communication period), to submit to the ANPD a statement that it has complied with the communication determination and evidence of how this was done.

Data breach record and submission of documents

The ANPD expressly determines that the data controller must keep a record of all security incidents involving personal data for at least five years, regardless of whether they have been reported or not.

Thus, in addition to being prepared to act diligently, assertively, and quickly, companies will need to be ready to document the entire data breach and its stages of identification, response, remediation, and communication.

The record must contain at least:

• a description of the nature and category of the personal data affected;
• the technical and security measures used for the protection of the data, observing commercial and industrial secrets;
• the risks related to the incident with identification of possible impacts to data subjects;
• the reasons for the delay, in the event that the communication has not been made within the period established in the caput of article 6 of the resolution;
• the measures that have been or will be adopted to reverse or mitigate the effects of the incident, where applicable;
• the date on which the security incident became known; and
• the contact for information – and, where applicable, the contact details of the person in charge.

At any time, the ANPD may require the data controller to submit a record of the affected data processing operations, the Data Protection Impact Assessment and the Incident Handling Report, which contain copies and relevant information to describe the incident and the measures taken.

The company's documented and assertive response in the event of incidents becomes even more fundamental. The controller must be prepared not only to carry out communications with the required content and form, but also be ready to account for its activities in relation to the event. It's important to show your preparation before, during, and after.

Own administrative process

Data breach reports now require its own administrative process (Security Incident Reporting Process), through which the ANPD will inspect the case and the measures adopted by the company.

In the event of non-compliance with the provisions of the new regulation, the controller may respond to administrative sanctioning proceedings.

The new regulation is in line with the way in which Machado Meyer's Digital and Personal Data Protection practice deals with situations of this nature. A holistic and strategic approach, connected with the firm's crisis management expertise and the technical work of the other practices. We remain available to answer any questions on the subject.

Category: Real estate

On April 10, the São Paulo City Council rejected 17 of the 58 vetoes made by mayor Ricardo Nunes in the partial revision of the Land Parceling, Use and Occupation Law. The text is better known as the Zoning Law (Law 16.402/16), instituted through Law 18.081/24 on January 19, 2024.

The revision carried out by mayor Ricardo Nunes aimed to reconcile the objectives of the Zoning Law jointly with the mid-term review of the Strategic Master Plan of São Paulo (Law 17.975/23). However, the São Paulo City Council, in an ordinary session on April 10, discussed and voted to overturn 17 vetoes. The decision was promulgated by the president of the Chamber, Milton Leite, at the request of the mayor, on April 17.

The justifications presented by the City Council for the partial overturning of the vetoes focused on encouraging sustainability and the production of social housing in the city. Measures to support the so-called "smart" cities to foster sustainable practices in buildings through incentives for environmentally responsible technological and constructive innovations are highlighted.

The most relevant changes are presented in the updated version of our e-book: Revision of the Master Plan and Zoning Law.

Category: Real estate

The Legal Framework for Secured Transactions (Law 14.711/23) represents a turning point for the Brazilian financial and real estate sector. Promoting legal certainty and efficiency in the use of guarantees, the legislation promises to dynamize the credit supply, reduce costs, and stimulate investments.

In this new ebook, we explore the real estate aspects of the legislation, unfolding its practical and strategic implications for industry professionals, investors, and those interested in the credit market.

The publication addresses the innovations introduced, such as the flexibilization and modernization of the secured fiduciary sale. We also detail some novelties, such as the subsequent secured fiduciary sale and the extension of the secured fiduciary sale.

In addition to other topics, the ebook also covers changes in foreclosure procedures and auctions, as well as the revitalization of the mortgage, which, although less utilized, gains new momentum with the possibility of extrajudicial foreclosure.

Category: Life sciences and healthcare

On April 23, 2024, the Federal Senate approved the final consolidated text of Bill No. 6,007/23, which aims to establish a legal framework for research with human beings in Brazil, and establishes the National System of Ethics in Clinical Research with Human Beings.

After 7 years under discussion in the National Congress,  the text initiated in the Federal Senate was revised by the  Brazilian House of Representatives at the end of 2023, having been approved in this House in the form of a substitute (Bill No. 7.082/17).

Check below the main aspects involving the current regulation of clinical research in Brazil and the final text approved on an urgent basis.

Background

In practical terms, Brazil already has a structured clinical research system that includes the National Health Council (CNS), the National Research Ethics Commission (Conep), and Institutional Review Boards – IRBs (Comitês de Ética em Pesquisa – CEPs) established in hospitals, research centers, and academic institutions.

Bill No. 6.007/23, however, intends to provide a legal foundation for applicable regulations and oversight of public and private institutions conducting research with human beings in Brazil.

According to the approved text, research with human beings includes the handling of their data, information or biological material, directly or indirectly. It can be divided into three categories:

• Scientific, technological or innovation research – Study that interacts with human beings (individually or collectively), in a direct way, without the objective of registering the product under research.
• Clinical research – A set of scientific procedures developed in a systematic manner with the aim of:

- evaluating the action, safety and efficacy of drugs, products, techniques, procedures, medical devices or health care for preventive, diagnostic, or therapeutic purposes;

- verifying the distribution of risk factors, diseases or conditions in the population;

- Assessing the effects of factors or states on health.

• Clinical Trial – Its purpose is to discover or confirm the clinical, pharmacological, or any other pharmacodynamic effects of the investigational drug, to identify any reaction to the product, or to study its absorption, distribution, metabolism, and excretion, to analyze and verify the action, safety, and efficacy of the investigational

In these cases, research protocols will be subjcet to a prior ethical analysis, which form now on will be carried out in a single instance by Institutional Review Boards, putting an end to the double review carried out by Conep, which today still occurs in specific cases.

In addition, the text established a maximum period of 30 days for deliberation by the IRBs, except when it comes to research of strategic interest to the SUS, whose deadline for issuing an opinion will be 15 days.

Main changes in Bill No. 6.007/23the final text

The Federal Senate promoted about 60 amendments to the substitute text proposed by the House of Representatives, in its most of editorial nature.

The main modification concerns the financial responsibility of the research sponsors in Brazil.

The version approved by the House of Representatives provided that, in the case of research sponsored by governments, national or international government agencies, or non-profit institutions, the collaborating Brazilian institution could assume and exempt the responsibilities of one or more sponsors from the obligation to indemnify and provide health care for any damages caused. However, said provision was fully removed by the Senate.

Other highlights are:

• Exclusion of the possibility of having Independent Institutional Review Boards;
• Reestablishment of the National System of Ethics in Clinical Research with Human Beings (SNEPCSH), composed of a national ethics body (current CONEP) and a local ethics analysis body (IRBs);
• The National Research Ethics Commission (current CONEP) will now integrate the Ministry of Health, having the competence to regulate, supervise, and carry out the ethical control of research;
• The research with pregnant women will be mandatorily preceded by similar research with women outside the gestational period, except when the pregnancy or the unborn child is the fundamental object of the research;
• Studies with biological materials of human origin should avoid discrimination and stigmatization of individuals, families, or groups, regardless of the benefits obtained from the research;
• Exclusion of the possibility of having an IRB to waive the requirement of prior individual informed consent for future use of biological data and materials in case of new research of relevant social value or deemed unfeasible without waiver;
• Clinical trials may be initiated within 90 days from the submission of the request for approval to Anvisa, regardless of the Agency's manifestation, provided that the ethical protocol has been approved;

• Elimination of the "researcher/investigator-sponsor" player, under the justification that such a figure could lead, in practice, to the exemption of responsibilities on the part of the sponsor.

Criteria for Post-Study Provision

Access of the investigational drug post-study may be interrupted on the following situations:

• decision of the research participant or legal representative;
• cure of the disease or introduction of a satisfactory therapeutic alternative;
• absence of benefit from the continued use of the investigational drug to the research participant, considering the risk-benefit ratio outside the context of the clinical trial or the emergence of new evidence of risks related to the safety profile of the investigational drug;
• an adverse reaction that makes it impossible to continue the investigational drug;
• impossibility of obtaining or manufacturing the investigational drug for technical or safety reasons - provided that the sponsor provides an equivalent or superior therapeutic alternative existing on the market;
• after 5 years from the commercial availability of the investigational drug in Brazil; or
• availability of the product in the SUS.

The text will be analyzed by the President of the Republic, who may sanction it with or without veto. Subsequently, complementary regulations on operational topics are expected to be published, such as:

• availability of information about the research on a publicly accessible website;
• definition of standard operating procedures and best practices;
• rules for biobanks and biorepositories;
• mandatory clauses for clinical research contracts;
• definition of special groups;
• procedures for suspension or termination of IRBs;
• monitoring rules for research;
• definition of information and procedures for ethical analysis by the IRBs;
• creation of a national registry of volunteers in bioequivalence studies;
• requirements for the design and implementation of a post-study supply program or continuation of the experimental treatment;
• specificities of research in the humanities and social sciences;

The Life Sciences & Health practice  can provide more information on the topic.

Category: Life sciences and healthcare

On April 8, 2024, the Brazilian National Health Surveillance Agency (Anvisa) published Normative Ruling 290/24, which establishes an abbreviated analysis process for high-risk medical devices (classes III and IV), effective as of June 3. The measure allows the process to be expedited at the request of the companies, as long as the devices have already been recognized by an equivalent foreign regulatory authority (AREE).

AREEs are foreign regulatory entities that have practices aligned with Anvisa’s and are recognized as trusted bodies. Recognition by an AREE ensures that the products authorized for commercialization have been properly evaluated and meet standards of quality, safety, and efficacy similar to Brazil.

Anvisa RDC 741/22 establishes general criteria for acceptance of analyses conducted by AREE in the sanitary surveillance at Anvisa, through an optimized analysis procedure. The resolution provides that specific rules will establish criteria and procedures to define AREEs concerning a given health surveillance process or product category.

Recognized AREEs for Medical Devices Marketing Authorization

For the adoption of the optimized procedure for analyzing medical device’s marketing authorization previously recognized by AREEs, the following entities and respective proof of registration or authorization must be considered, per Normative Ruling 220/24:

• Austrália: Australia Therapeutic Goods Administration (TGA) – Australian Register of Therapeutic Goods (ARTG);
• Canadá: Health Canada (HC) – Medical Device Licence;
• Estados Unidos: US Food and Drug Administration (US FDA) – 510(k) Clearance, Premarket Approval (PMA) ou 513 (f)(2) "De Novo"; e
• Japão: Japan Ministry of Health, Labour and Welfare (MHLW) – Pre-market approval (Shonin).

Requirements for Optimized Procedure Adoption

The optimized review procedure will be applied for medical device petitions authorized by at least one AREE from the list above.

In addition, the products intended for the Brazilian market must have the same production characteristics, indications, and intended use approved by the recognized regulatory authority, which must be demonstrated by documentation.

To apply for medical device marketing authorization via an optimized procedure, the application request must be based on the documents listed in Anvisa RDC 751/22 and Anvisa RDC 36/15, and the supplementary documentation established by the new rule:

• Statement of Eligibility Assessment by the Optimized Analysis Procedure, which must contain company data, AREE’s reference, and product information – such as name and indication of use;
• document proving the marketing authorization issued by the AREE; and
• medical device instructions of use in force in the jurisdiction of the AREE.

According to the new Normative Ruling, the adoption of the optimized analysis procedure does not entail a change in the chronological order of the petitions and does not condition Anvisa's approval.

The Life Sciences & Health practice can provide more information on the topic.

Category: Life sciences and healthcare

On April 15, 2024, the Secretariat of Science, Technology and Innovation and the Department of  Industrial-Economic Health Complex (CEIS) presented clarifications on the measures taken by the Ministry of Health (MoH) to comply with the determinations of the Federal Audit Court (TCU) made on October 2022. These measures were adopted after the suspension of Productive Development Partnerships (PDPs), as decided by the TCU, in response to the release of the new strategy for the CEIS by the government (check out our previous analysis on the topic here).

The PDP is a type of governmental partnership that aims to establish cooperation between public and private laboratories for the development, training and transfer of technologies considered strategic for the Unified Health System (SUS).

Since 2017, the TCU's Specialized Health Audit Unit (AudSaúde) has been supervising the issue, and had already issued recommendations to the MoH to improve the regulatory framework applicable to partnerships (TCU Ruling 730/17).

At the end of 2022, the TCU Ruling 2.015/23 (case TC 034.653/2018-0) established, among other topics, that it would be up to the MoH to instruct public laboratories on the need to conduct a selection or pre-qualification process of the private partner, or adequately justifying when its realization is not feasible.

In addition, a reformulation of the Technical Committee (CTA) and the Deliberative Committee (CD) regiments was determined, establishing:

• objective parameters for the analysis of projects and the assignment of grades to proposals;
• criteria for the division of responsibilities of public laboratories – when more than one PDP project proposal is approved for the same product; and
• the need for the CTA to re-examine proposals for the same drug and tie-breaking criteria and to readjust market percentages.

Main points presented by the  MoH to the TCU

The  MoH argued that certain TCU determinations were based on a normative act that has already been revoked – Decree No. 9,245/2017, which instituted the National Policy for Technological Innovation in Health and was replaced by Decree No. 11,715/2023, the current National Strategy for CEIS’ Development.

In this sense, the MoH requested that the deadlines for compliance with certain actions should start from the publication of the PDP program’s future ordinance ( the results of Public Consultation 54/23 are still in the analysis phase).

In addition, the MoH also reported that:

• the topic was put into public consultation to broaden the discussion, support decisions, promote dialogue, and legitimize transparency and social participation to obtain information, opinions, and criticisms about the PDP Program;
• the update of the internal regulations of the CTA and the CD will be made after the publication of the PDP’s new ordinance;
• the merit points that were the subject of the TCU's determinations were addressed in the ordinance’s draft subjected to public consultation; and
• All public institutions were informed, by letter via e-mail, of the need to conduct a selection or pre-qualification process of the private partner, or adequate justification in case of unfeasibility.

Case TC 034.653/2018-0 had been included in the plenary agenda of April 17, 2024, but was then removed without justification.

Public Consultation 54/23 Status

The MoH received 1,489 contributions to Public Consultation 54/23. Currently, they are being consolidated by CEIS’ Department, and, once consolidated, an administrative proceeding will be initiated to regulate the proposition and processing of the normative act.

This process will be forwarded to the Federal Attorney General's Office, which, through the MoH’s Legal Counsel (Conjur/MoH), will analyze the feasibility of the new rule and issue an opinion for the edition of the final version of  PDPs ordinance, as established in the manual for the preparation, proposal, processing and consolidation of normative acts of the MoH (Ordinance 2,500/17).

At the same time, the process must be forwarded for analysis by the Executive Secretariat and the  MoH office for signature and subsequent publication in the Official Union Gazette.

 Public Consultation 53/23, which presented a draft regulation for the Local Innovation Development Program (PDIL) within the scope of the CEIS, should also follow the same procedure.

The Life Sciences & Health practice can provide more information on the topic.

Category: Life sciences and healthcare

The Brazilian healthcare system has been undergoing an intense process of digital transformation, through the application of technological tools such as AI, blockchain, IoT, and others in management processes, research & development, healthcare, and public policies. This movement requires significant changes in sector-specific legislation and the behavior of the stakeholders involved. Our Life Sciences and Healthcare experts bring the main regulations applicable to the topic, as well as perspectives for the near future.

Category: Litigation

The environmental issue has gained legislative attention in recent times, both in the constitutional sphere and in the ordinary sphere, given the recent bills that address the issue.

Environmental damage has certain complexities, such as the difficulty of reversing it, which contributes greatly to the worsening of disasters. Another complex issue is the volume of financial resources needed to rehabilitate the environment and compensate potential victims.

Once environmental damage has been established, it must be repaired. However, this repair is not always easy to achieve or solve immediately.

Two recent bills in the pipeline aim to regulate the issue of environmental repair in order to meet civil society's concerns about environmental protection.

Bill 2,257/23 provides in its article 2 that "the economic activity of the company responsible for the occurrence or imminent risk of an accident or disaster may be suspended for as long as there is no full repair for the economic, social, cultural, and environmental damage produced or for as long as the situation of imminent risk that has led to the forced displacement of people persists.”

This proposal, however, could have a practical effect opposite to what is expected. This is because the act has a direct impact on the company's financial capacity and may even make it impossible to fulfill the obligation to repair the environmental damage.

Bill 740/23, in turn, proposes suspending the payment of profits to shareholders of corporations involved in environmental disasters.

This suspension violates article 202 of the Brazilian Corporations Law (Law 6,604/76), which gives shareholders the right to receive as a mandatory dividend the portion of profits established in the bylaws. It also violates fundamental principles such as due process of law and free enterprise, which must be preserved because they have constitutional protection.

It is easy to see that bills with a simplistic approach, without a definition of environmental damage, the dimensions and establishment thereof, and without observing the principle of due process of law, which guides all the other principles of the constitutional order, can generate inefficiency in terms of their applicability, as they violate basic principles enshrined in the Federal Constitution (FC) and in laws that have already been regulated.

Suspending a company's activities, even temporarily, has an impact on the performance of its economic activities. Ceasing payments to the shareholders of corporations involved in environmental disasters violates fundamental principles such as free enterprise (article 170 of the Federal Constitution).

It should be remembered that there are already laws in our legal system that deal with protection of the environment and affected communities, such as Law 6,938/81, which systematized environmental law by creating the National Environmental Policy, Law 9,605/98, which regulates environmental crimes and consequent punishments, including criminal liability for legal entities, and Law 12,334/10, which establishes the National Dam Safety Policy, among others.

Therefore, in addition to taking into account the basic principles of the Federal Constitution, the bills in progress must be careful not to conflict with rules already in place.