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Henrique Kruger Frizzo

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Henrique Kruger Frizzo joined the firm in 2004 and became a partner in 2014. He is the leader of the Life Sciences group and also integrates the Public and Regulatory Law group. He acts in the preparation of legal opinions and consultations on topics of his expertise, including tenders and contracts with the government, public service concession contracts and public-private partnerships. He has experience in complex negotiations with the government and assists clients in structuring effective government relationships. He also acts in the identification of irregularities and illicit acts in contracts and relationships with the government and in the area of sales to defense and public security agencies, including in the structuring of technological compensation agreements.
In the Healthcare sector, he advises pharmaceutical, medical device and other companies in the sector on a wide range of matters, including transactions involving commercial agreements and complex negotiations with the government and health technology transfer agreements. He also advises clients on market access strategies, including procedures for the incorporation of new health technologies into SUS and ANS, and represents companies in CMED administrative proceedings. Henrique prepares consultations involving clinical research and regulatory issues, reviews promotional materials, and acts in administrative litigation involving local health authorities and ANVISA. Additionally, he provides support in compliance issues, digital health and analysis of the constitutionality/legality of legislation. Due to his expertise, he participates in the drafting of bills of law and regulations for the industry.
In Public Law, Government Affairs, Regulatory and Compliance, he has extensive experience in corporate investigations, with a focus on government procurement and corruption, and their respective consequences in the civil and administrative areas. We assist clients in defining strategic decisions regarding the results of the investigation and participate in the defense before or during the negotiation with the civil and administrative police authorities responsible for the cases.
In Healthcare & Life Sciences

3rd Edition – Latin America Healthcare and Life Science 360 Conference

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Join Us at the 3rd Edition of the Latin America Healthcare and Life Sciences 360 Conference
We are excited to announce we will be joining the 3rd edition of the Latin America Healthcare and Life Sciences 360 Conference on May 6th in São Paulo. This event, organized by Trench Rossi Watanabe brings together key industry leaders and Baker McKenzie speakers to discuss the latest trends and developments in healthcare and life sciences.
The conference agenda promises a day full of insightful discussions on a variety of critical topics, including market expectations, regulatory changes, market access, data privacy, and ethical AI. Our roster of expert speakers will provide valuable insights and share their extensive knowledge on these subjects.

In addition to the stimulating sessions, attendees will have the opportunity to network with industry experts and peers. Don’t miss out on this chance to gain a deeper understanding of the healthcare and life sciences landscape in Latin America.

For more details and to register for the event, please click here. We look forward to seeing you there!

In Product Regulation & Liability

Brazil:  Senate approves controversial bill on clinical research involving human biological material

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On 23 April 2024, the Federal Senate approved Bill 6,007/2023, which originated as Bill 200/2015, and which generated intense debate among all those involved in the clinical research ecosystem. While the bill was supported by the economic sectors and part of academia due to the stability and security it brings to clinical research in Brazil, various social segments, part of academia and government authorities who are members of the system raised concerns about the possibility of weakening national ethical guidelines and dismantling the CEP/CONEP system.

In Brazil

Brazil: The National Health Surveillance Agency publishes a new resolution regarding the recall of drugs

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The National Health Surveillance Agency published Resolution RDC No. 625/2022, which provides the minimum requirements related to the marketing authorization holders’ obligation to communicate the implementation of a drug recall to the competent authorities and consumers. This is in case there is sufficient evidence or proof of quality deviation resulting in risks or consequences to health, as well as due to the cancellation of registration related to safety and efficacy.

In Cybersecurity, Data and Tech

Life Sciences Business Evolution Series – Report 1: How Digital Transformation and Data Are Shaping Business Models

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As digital transformation reshapes business models with different emphases across regions, digitally enabled strategies are helping companies transition from product-only offerings to product-service hybrids, orient to patient mapping, pre-diagnostics solutions and enhancing treatment administration.

In Brazil

Brazil: RDC No. 497/2021 – New regulation on certification of good practices

by and 2 Mins Read

The Brazilian National Health Surveillance Agency (“Anvisa”) published Resolution RDC No. 497/2021 (“RDC 497/2021”) setting forth the new administrative procedure for obtaining the Good Manufacturing Practices Certificate, as well as the Good Distribution and/or Storage Practices Certificate. RDC 497/2021 modifies the general conditions for certification, as provided for in its Chapter II, to facilitate the certification process.

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