Recognised Practice Areas

The firm was recognised in the following practice areas:

Individual Recognitions

In this edition, the following professionals were recognised:

The full results for the cycle are available on the firm’s Chambers profile, here.

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This recognition celebrates the technical excellence and dedication of our Media & Entertainment team, composed of Leticia Provedel, Eurico Barreto, Gabriela Freire, João Harres, Luiza Alkaim, and Mariana Vicentini Taylor. The ceremony was attended by partners Eduardo Peukert Mascarenhas Lopes and Rafael Alves, who represented the firm and accepted the award on behalf of the team.

We congratulate our professionals on this achievement and reaffirm our commitment to quality, innovation, and leadership in the legal Media & Entertainment sector.

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Fabrine joins the firm with a solid career, bringing extensive experience in the maritime, offshore, and oil & gas industries. She is a member of the Chartered Institute of Arbitrators (MCIArb), is listed as an arbitrator at the Brazilian Center for Mediation and Arbitration (CBMA), holds an LL.M in International Commercial Law from the University of Aberdeen with a focus on international arbitration, and an MBA from Fundação Getúlio Vargas.

Her practice includes negotiations and drafting of complex contracts, litigation strategies, and alternative dispute resolution methods (ADR). Additionally, Fabrine serves as Secretary-General of the Maritime and Port Law Commission of the OAB/RJ and is a member of the Women’s International Shipping & Trading Association (WISTA).

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Our partner Frederico Hilzendeger also maintained his individual ranking in the same category, reaffirming his excellence and leadership in the field.

Congratulations to Frederico and the entire Private Wealth & Succession Planning team for their outstanding work and continued dedication that led to this important recognition!

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Industries & Sectors

Recognized Practices:

Individual Recognitions:

Regions

In the Regions ranking, we reached the highest category in four areas in Rio Grande do Sul: Corporate/Commercial, Dispute Resolution, Labour & Employment, and Real Estate. Our partners Guilherme Rizzo Amaral, Jorge Cesa, and Fábio Baldissera were also distinguished in the top category for their respective specialties.

Práticas reconhecidas:

Reconhecimento individual:

These results reflect the unity, commitment, and dedication of each professional and practice area at our firm.

Check out the full results here.

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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.

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We congratulate Leticia and the entire team on this achievement!

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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!

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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.

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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

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