This year, we are proud to be among the leading law firms with the highest number of ranked departments and lawyers. We have been recognized in 8 practice area rankings and received 11 individual recognitions for our partners! Find the complete results below.

Recognized Areas:

Individual Recognitions:

The results can be found at this link.

O post Among the leaders in Chambers Brazil Contentious 2025: We are among the firms with the most ranked departments and lawyers. apareceu primeiro em Souto Correa Advogados.

We congratulate Leticia and the entire team on this achievement!

O post The performance of our partner Leticia Provedel is recognized by The Legal 500 Brazil Awards 2025. apareceu primeiro em Souto Correa Advogados.

This year, 7 of our practice areas received recognition and 10 of our lawyers have been individually recognized across 12 practice areas. 

See the consolidated results below.

Ranked practice areas:

Ranked lawyers:

We congratulate all the ranked individuals and their teams for the results achieved, which demonstrate our international excellence in providing legal services!

O post Our commitment to excellence continues to be internationally recognized by Chambers Global 2025! apareceu primeiro em Souto Correa Advogados.

According to Giácomo, one of his goals as the new CEO is to consolidate our firm’s position in the Brazilian market by reinforcing our commitment to diversity and seeking technologies that provide a competitive advantage.

“We believe that technology can make our lives easier and provide better service to our clients.” Regarding another objective during his term, he states: “We want to create an environment where diversity is part of our culture and way of doing things.”

Another focus during Paro’s term will be the exploration of ongoing tax reforms in Brazil. As companies adapt to new regulations, we anticipate an increase in this area of work.

“We expect a huge increase in demand in the tax department because companies will have to live with both systems for some time, which will create an unprecedented level of complexity,” notes Paro.

Giácomo Paro was promoted to partner in 2020, after joining Souto Correa in 2016.

Learn more about this new moment for our firm in the article “Souto Correa announces new CEO” published by Latin Lawyer.

O post We Announce Giácomo Paro as Our New CEO apareceu primeiro em Souto Correa Advogados.

On May 29, 2024, the President of the Republic sanctioned Federal Law 14,874/2024, which established the principles, guidelines, and rules for conducting clinical trials with humans by public or private institutions in Brazil.

Federal Law 14,874/2024 established rules that seek to (i) harmonize the Brazilian regulatory environment with international standards and best practices in clinical trials; and (ii) supervise public and private institutions that conduct research with human beings in Brazil. As well as covering clinical trials into medicines, the law also applies to medical devices and advanced therapy products.

The sanction is a historic milestone and expands Brazil’s potential to stand out on the international clinical trial scene, removing gaps and legal uncertainties by regulating the issue at the federal level.

Until this time, the issue was regulated through resolutions issued by the National Health Surveillance Agency (“Anvisa”) and the National Health Council (“CNS”).

When does the law come into force?

On August 27, 2024 (90 days after the publication in the Federal Register).

Vetoes issued by the President of the Republic:

The President of the Republic vetoed two articles. The first veto was over the legal provision that allowed the commercialization of experimental drugs to participants after 5 (five) years from the commercial availability of the experimental drug in Brazil.

The reasons for the veto indicate that setting a maximum time limit for the supply of the post-study drug would be contrary to the public interest, as well as hurting the rights of clinical trial participants and jeopardizing the possible development of ethical research based on the principles of dignity, beneficence, and justice. In addition, the veto points out that there was no maximum time limit for the continuation of the free supply of the experimental drug post-study to trial participants, and that the supply should be continued regardless of its commercial availability by the private sector.

Moreover, President Lula vetoed the provision that required the Public Prosecutor’s Office to be notified of the participation of indigenous people in clinical trials, as it violated the principle of isonomy.

Despite the publication of the law, vetoes will be analyzed by the National Congress and must be rejected or confirmed. Congress would have 30 days to deliberate on presidential vetoes in a joint session of senators and the house of Representatives, and an absolute majority of Congress is required to reject vetoes (arts. 57, §3, IV and 66, Federal Constitution). Nevertheless, this deadline has already passed, and National Congress is still not considering the President’s vetoes.

If the Congress rejects the vetoes, the corresponding parts of the law will be sent for promulgation by the President of the Republic within 48 hours (art. 66, §7, of the Federal Constitution).

Note published by the Ministry of Health:

In a note published on August 27, 2024, the Ministry of Health reported that:

Clinical trial: established legal concept

The Federal Law established the concept of clinical trial as the set of scientific procedures developed in a systematic way with humans aiming to:

The goals:

The Federal Law aims to:

It is worth noting that the study conducted by the Pharmaceutical Research Industry Association (“Interfarma”), IQVIA, and Aliança Pesquisa Clínica Brasil, estimates that by rising to 10th position in the overall clinical trial ranking, Brazil could attract direct investment estimated at R$ 3 billion per year, with more expressive economic impacts in the order of R$ 5 billion per year¹.

Institution of the National System of Ethics in Research with Human Beings:

To be regulated by the Executive Branch, the National System of Ethics in Research with Human Beings is divided into:

All trials with humans will be subject to prior ethical analysis, to be carried out by the CEPs, which cannot exceed 30 working days from the date of acceptance of the full research documents, and this acceptance, or its denial, must be made by the CEP within ten working days from the date of submission.

Trial of strategic interest to the Unified Health System (SUS) and which is relevant to dealing with public health emergencies will have priority and special analysis procedures so that the deadline for analysis cannot exceed 15 working days from the date of receipt of the research documents.

Ethical and scientific requirements:

The Federal Law established the following technical and scientific requirements to bring legal certainty to clinical trial participants:

Legal protection for trial participants:

The law guarantees trial participants protection, whose participation is conditional on the express authorization of the participant or their legal representative, by signing an Informed Consent Form.

Participants may not be paid. However, Federal Law 14,874/2024 allows payment for the participation of healthy individuals in phase I clinical trials or bioequivalence trials, provided that the participant: (i) joins the national register of volunteers in bioequivalence and phase I studies (to be regulated); (ii) does not simultaneously take part in more than one study. 

Furthermore, the following do not constitute remuneration or advantages for the research participant: (i) reimbursement of expenses with transportation, food, or prior material provision; (ii) other types of reimbursement necessary, according to the research project.

Besides, the sponsor must guarantee the participant compensation for any damages suffered as a result of their collaboration in the research, with the receipt of necessary health care related to these damages.

Last but not least, the trial will be conducted in such a way as to guarantee the anonymity and privacy of the participant, as well as the confidentiality of the information.

Overview of Sponsor’s responsibilities:

The Federal Law defines a sponsor as a natural or legal person, under public or private law, who supports research by providing funding, infrastructure, human resources, or institutional support.

The sponsor’s main responsibilities are:

The sponsor, ultimately responsible for the trial, may delegate the execution of certain functions to the Clinical Research Representative Organizations (CROs), which will assume shared responsibility for the object of the delegation.

Criteria for post-study supply:

The Federal Law provides that the free supply of the experimental drug under the post-study supply program may be interrupted upon submission of a justification to the CEP, only in the following situations:

Anvisa’s deadline for analysis of applications for clinical trials:

To rush the process of making new products available on the market, the Federal Law established a maximum time limit for approval of clinical trials with humans by Anvisa.

The health analysis related to primary petitions for clinical trials with humans intended to obtain the marketing authorization of the product under investigation cannot exceed 90 working days. If Anvisa does not issue a decision within this period after the primary clinical trial application has been received, clinical development can begin, provided it contains the relevant ethical approvals.

Main points to be regulated:

Despite the publication of the legal framework for clinical trial, some issues will be the subject of regulations, such as:

Souto Correa’s Life Sciences & Healthcare practice can support your team in clinical trial projects. Please contact us by e-mail: lifesciences@soutocorrea.com.br and/or anderson.ribeiro@soutocorrea.com.br.

You can download this content on it’s visual one-page version clicking here

[1] https://www.interfarma.org.br/wp-content/uploads/2023/08/Pesquisa-clinica-2022_atualizado.pdf

O post Clinical Trial with humans: all you need to know about the legal framework recently approved in Brazil apareceu primeiro em Souto Correa Advogados.

1. Main Objectives of the Clinical Research Law: 

• Foster technical-scientific development. 
• Improve legal security for those involved in clinical research. 
• Reduce approval times for conducting clinical research in Brazil. 
• Protect the dignity, safety, and well-being of research participants. 

2. Is the Clinical Research Law fully in effect? 

• The law came into effect on August 28^th, 2024, but several of its provisions still depend on further regulation. 
• There are 2 presidential vetoes to the text of the law that are still pending review by the National Congress. Therefore, the law may still be adjusted. 

3. Why does this matter? 

• Clinical research is a very important activity for various health-related industries, such as pharmaceuticals and medical products, and is now regulated by law. Previously, there were only scattered rules from the National Health Council, but no general regulation. 
• With a greater degree of autonomy for Institutional Review Boards (known as CEPs, for its acronym in Portuguese), the need for double approval that occurred before will no longer happen. 
• By bringing principles, guidelines, and rules for conducting research, as well as defining responsibilities among researchers, sponsors, and research institutions, the enactment of the law suggests a deep understanding and adjustments in both protocols and research contracts, which must comply with the provisions of the law and regulations. 

4. Who needs to be aware of it? 

• Companies sponsoring clinical research. 
• Companies providing clinical research services. 
• Researchers and Research Institutions. 
• Institutional Review Boards. 

5. Some points that still need regulation: 

• Accreditation and/or certification of CEPs. 
• Definition of the degree of risk of the research. 
• Auditing
• Biobank and Biorepository. 
• National Registry of Volunteers for bioequivalence or phase I studies. 
• Rules on publicity, transparency, and monitoring of research. 
• Rules on the manufacture, use, dispensing, importation, exportation, storage, and disposal of products intended for clinical research. 

Souto Correa’s Life Sciences & Healthcare team is available to provide more information on the subject and assist in adapting to the new Regulation.

O post Brazil: Legal Framework for Clinical Research with Human Subjects apareceu primeiro em Souto Correa Advogados.

Also, a detailed procedure was established for requesting Technical Opinions and submitting the corresponding reports, seeking greater efficiency and clarity in the process of rehabilitating contaminated areas.

The stages of the environmental management were grouped into blocks as follows: (i) “Block 1 – Identification” (Preliminary Assessment and Confirmatory Investigation); (ii) “Block 2 – Diagnosis” (Detailed Investigation, Risk Assessment and Intervention Plan); and (iii) “Block 3 – Intervention” (Implementation of the Intervention Plan and Monitoring).

Those legally responsible must complete all the stages of a block before filing the results with Cetesb, except in situations of danger, in which the adoption of emergency measures is foreseen.

Currently, there are more than 7,000 contaminated areas registered on the environmental agency’s official list. In practice, this number is possibly higher, as there are areas that have not been updated in the document yet.

The new rules aim to ensure greater agility in the progress of environmental management procedures for contaminated areas or areas with potential for contamination at Cetesb.

The Environmental and Sustainability team at Souto Correa is available to provide more information and clarifications on the matter.

O post Environmental agency provides for grouping the stages of contaminated areas management into blocks apareceu primeiro em Souto Correa Advogados.

The procedure covers all manufacturers, importers, distributors and traders of the products detailed in the new DD that generate waste subject to a waste take-back system in the state of São Paulo, such as companies in the sectors of lubricating oil, food, beverage, medicine, agricultural pesticide, electronics and batteries.

DD changes the deadline for submitting the results report to July 30 of each year and establish new quantitative targets, taking into account the targets provided for in the National Solid Waste Plan (Planares), established by Federal Decree No. 11,043/2022.

The requirement to attest compliance with a waste take-back system as a condition for environmental licensing corresponds to a trend that has been gaining strength in several Brazilian states. In São Paulo, this practice was set in 2018 with DD No. 076/2018/C, establishing a regulatory framework on the matter.

Despite the benefits of aligning state and federal goals for the management of procedures, with the new DD nº 051/2024/P, the sectors covered by the National Solid Waste Policy (PNRS) must meet the new deadlines and goals to avoid impacts on their environmental licenses for projects located in the state of São Paulo.

The Environmental and Sustainability team at Souto Correa is available to provide more information and clarifications on the matter.

O post Cetesb establishes new procedure for demonstrating compliance with waste take-back system in the context of environmental licensing apareceu primeiro em Souto Correa Advogados.

The Resolution determines the competence for analyzing and approving the CAR and the rural property’s environmental compliance project, the property information considered for analysis by the Integral Technical Assistance Coordination (CATI), the possibility of presenting justifications and clarifications about the results, the means of notification, the deadlines for applications, the methods for reviewing previous commitments, among other aspects.

If the result of the analysis identifies that the rural property is not in compliance, the Environmental Regularization procedure sets forth the need to: i. adhesion in the Environmental Regularization Program (PRA) by the owner or possessor of the rural property within one year of the end of the CAR information verification stage; and ii. the execution of an Environmental Regularization Program Commitment Term (TCPRA) or Environmental Adequacy Commitment Term (TCA) between the owner/possessor and CATI/SAA.

For the rural properties whose owners or possessors do not adhere to a PRA, there is the possibility to submit a Degraded and Altered Areas Recovery Project (PRADA) or an Environmental Adequacy Project (PAA) to SICAR-SP.

The new regulation seeks to enable the regularization of rural properties that are not in compliance, mainly, with the rules of the Forest Code, such as: i. absence of a percentage of legal reserve duly constituted and preserved with native vegetation on the property; ii. need to recover permanent preservation areas; iii. adjustments in legal reserve compensation measures, etc.

Resolution No. 50/2024 repeals SAA Resolutions 73/2020, 54/2021 and 30/2023, and will come into force 45 days after its publication. Access the full text by clicking the link.

The Environmental and Sustainability team at Souto Correa is available to provide more information and clarifications on the matter.

O post The state of São Paulo establishes the procedures for environmental regularization of rural properties and possessions apareceu primeiro em Souto Correa Advogados.

Ordinance SPA/MF No. 1,212, dated 07/30/2024, addresses the procedures for transferring the allocations from the fixed-odds betting lottery revenue, as outlined in §1-A of Article 30 of Law No. 13,756, dated December 12, 2018.

The initiative will encompass the revenue from all modalities of fixed-odds betting, including those conducted physically or virtually, as well as those involving real sports-themed events and virtual online gaming events.

It should be noted that, after deducting the payment of prizes and the income tax on the prizes, 88% of the collected revenue will be allocated to cover the operating and maintenance expenses of the betting operator. The remaining 12% will be reserved for social functions, as established by Law No. 13,756/2018.

Other highlights of the Ordinance include:

• The transfers will be made via payment through the Federal Revenue Collection Document (DARF) to the Single Treasury Account.
• The Betting Operator must make the transfers in accordance with the provisions of the Ordinance, under penalty of civil, administrative, and criminal liability.
• The transfers must observe the general principles of public administration and will be subject to accountability through monthly reports and oversight by the Secretariat of Prizes and Bets.
• In case the Bettor loses the right to receive the prize or request a refund, the amounts will be collected to the Single Treasury Account.
• The method of distributing the 7.30% transfer to entities of the National Sports System and to Brazilian athletes or those affiliated with sports organizations based in the country will be specifically regulated. This contribution stems from the use of their names, sports nicknames, images, brands, emblems, anthems, symbols, and similar items for the promotion and execution of the fixed-odds betting lottery, as per Article 30, §1-A, III, a) of Law No. 13,756/2018.
• The Secretariat of Prizes and Bets will issue specific guidance on the allocation of certain transfers in the sports area, for example, the 2.20% to the Brazilian Olympic Committee and 0.70% to the Brazilian Club Committee.
• For a period of 5 years, the Betting Operator must keep supporting documents of the transfers available to the Secretariat of Prizes and Bets.

The Corporate Law and M&A, Banking & Fintechs, Compliance, Public Law & Regulatory, and Consumer & Product Liability teams at Souto Correa are available to provide more information and clarifications on the matter.

O post Item 11: Ordinance SPA/MF NO. 1,212 apareceu primeiro em Souto Correa Advogados.