Brazil's Decree #12,651/2025 regulates the Clinical Research Act, establishing SINEP and balancing ethics with efficiency, analyzed here in Part 2.

Brazil's Civil Code reform tackles AI interactions, establishing transparency, accountability, and human oversight duties for civil liability in digital environments.

Brazil's proposed Civil Code reform (Bill 4/2025) addresses deepfakes and AI, setting rules for consent, personality rights, and mandatory content labeling.

The proposed reform of Brazil's Civil Code seeks to incorporate AI into civil law, sparking discussions on its impact and coordination with existing AI legislation.

Brazil faces significant regulatory challenges concerning internet anonymity, balancing freedom of expression with the need to combat unlawful practices and hate speech on digital platforms.

A regulação do anonimato digital no Brasil enfrenta desafios, buscando equilibrar liberdade de expressão com responsabilização por conteúdos ilícitos.

Decree 12,651/2025 operationalizes Brazil’s Clinical Research Act by establishing SINEP/INAEP, enforcing binding ethics and regulatory timelines, enabling single-CEP opinions for multicenter trials, and opening integrated INAEP–Anvisa procedures—setting the stage for faster, more predictable studies.

ADI 7875 challenges key provisions of Brazil’s Clinical Research Act on constitutional grounds—post-trial access, consent in emergencies, institutional liability—putting legal certainty at risk even as long-awaited regulations near publication.

U.S. FDA enforcement against compounded GLP-1 products highlights false equivalence claims on safety and efficacy, and Brazil faces a similar clinic-driven market—calling for ANVISA to tighten oversight, curb trademark misuse, and enforce compounding and dispensing rules.

Brazil can unlock leadership in clinical trials by pairing its new legal framework with clear implementing rules, better transparency tools, and technology integration—especially AI-enabled Real-World Evidence—while balancing IP protection and patient access.

Mega-events depend on strong IP frameworks—spanning trademarks, copyright, designs, and patents—to preserve exclusivity, curb counterfeiting and ambush marketing, and protect investments from organizers and sponsors while enabling technology used during the events.

Brazil’s new gaming law (Law 14,852/2024) broadens IP protection for electronic games—linking software and devices, opening a BRPTO registration path, and foreshadowing tighter, more specialized enforcement—while court practice and international models shape the next phase for disputes.

BRPTO has extended to October 27 the public comment deadline on proposed Chemistry-chapter guidelines for new uses of known products, which tighten novelty/obviousness and enablement standards—requiring in vivo data at filing and limiting support to exactly tested compounds.

Brazil’s luxury market is expanding despite global softness, and a stronger IP toolkit—position marks, trade dress, copyright, border measures, and favorable court rulings—is shaping a robust anti-counterfeiting environment.

Cybersecurity’s rise as a national-security imperative revives debate on compulsory licensing, but because effective defense depends on trade secrets and operational know-how, any emergency use must be narrowly tailored to avoid exposing sensitive methods while preserving incentives for R&D and cooperation with rightsholders.