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Partner
Gustavo Swenson Caetano
Areas of expertise
Experience
Gustavo is a specialist in transactional, regulatory and intellectual property matters related to the life sciences, health, food, agribusiness, technology and biotechnology industries. He represents local and international clients before regulatory and government agencies, such as the Brazilian Health Regulatory Agency (Anvisa), the Brazilian Agency of Supplementary Health (ANS), and the Ministry of Agriculture, Livestock, and Food Supply (Mapa). Gustavo also works with healthcare compliance and legal matters involving privacy and personal data protection.
Gustavo previously served as a Brazilian representative at the Japanese Intellectual Property Training Center, organized by the Japan Patent Office (Tokyo, 2013) and was a guest professor in a course on health compliance offered by Legal, Ethics & Compliance (LEC) between 2015 and 2019.
Gustavo is a member of the Food Lawyer Network (FLN) and a coordinator of Brazil’s National Industrial Hemp Association (ANC).
Education
Bachelor of Laws – Pontifícia Universidade Católica de São Paulo (PUC-SP);
Master of Laws (LL.M.) – George Washington University;
Specialization in Intellectual Property and Technology Law – Fundação Getulio Vargas (FGV);
Specialization in Bidding Procedures and Administrative Contracts – Fundação Getulio Vargas (FGV).
Recognitions
Chambers Brazil – Life Sciences (2022 – 2025);
Chambers Global – Life Sciences (2026);
Latin Lawyer 250 – Intellectual Property (2023 – 2026);
Legal 500 – Life Sciences: Next Generation Partners (2022 – 2025) Leading Partner (2026);
Análise Advocacia – Regulatory (2022 – 2024), Pharmaceuticals (2022) and São Paulo (2017).
Brazilian health regulator issues new rules on medical cannabis production
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Brazil publishes decree to regulate law on clinical trials involving human subjects
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Brazil’s Antitrust Authority releases market study on medicines manufactured for human use
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Public consultation on regulation of medicinal cannabis products opened in Brazil
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Anvisa approves new resolution regarding simplified marketing authorization in Brazil
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ARTICLE: Legal Risk Management and Crisis Response in Pharmaceutical Medicine Shortages
Medicine shortages in Brazil present significant regulatory, legal, and reputational risks for pharmaceutical companies, especially when they regard essential products. Though legal departments are central to managing these challenges, an effective crisis response requires coordinated action across the entire organization. The following recommendations apply to legal leaders at pharmaceutical companies and encompass both legal strategies and broader crisis management measures for mitigating exposure and protecting market access.
Click here and read the article published at The Legal Industry Reviews.
Areas of expertise
A Decade of Brazil’s Clean Companies Law: Progress and Challenges
Ever since Brazil’s Clean Companies Law (Law No. 12,846/2013) formally took effect in January 2014, the country’s corporate integrity culture has become significantly stronger. The OfÏce of the Comptroller General (CGU) has been at the forefront of this shift in its role as a regulatory enforcer for the private sector. In 2024, Brazilian agencies initiated a total of 260 enforcement proceedings against companies, which primarily involved undue advantages to government ofÏcials (the administrative offense closely related to bribery) and instances of fraud in public bids and contracts. We expect the corporate integrity landscape in Brazil to continue evolving in the wake of further regulatory changes, technological progress, and increasing transparency and corporate responsibility requirements.
Click here and read the article on The Legal Industry Reviews.
Areas of expertise
Recent Developments in Brazil’s Clinical Trial Framework
2024 presented an intensely dynamic legislative and regulatory landscape for the life sciences industry in Brazil, with important developments in several areas. Among these, Congress has finally passed a federal statute on research and trials involving human subjects. Federal Law 14,874/2024 established the National System of Ethics in Research with Human Beings (the “System”). This law regulates Research Ethics Committees (CEP) and sets parameters for protecting the rights of trial subjects and the legal responsibilities of investigators and sponsors.
Click here and read the article on The Legal Industry Reviews.
Areas of expertise
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