MEDIA & PUBLICATIONS

1. What is the current legal landscape for Life Sciences Law in your jurisdiction?

Brazil’s Life Sciences legal landscape is characterized by regulatory consolidation, institutional convergence, and increasing execution complexity, rather than sweeping legislative reform.
At the statutory level, the framework remains anchored in:

• The Federal Constitution, notably the right to health (Article 196), which strongly influences public policy and litigation;
• The Industrial Property Law (Law No. 9,279/1996) governing patents and regulatory exclusivities;
• The Sanitary Law (Law No. 6,360/1976) and related ANVISA regulations;
• Sector-specific rules on clinical research (recently regulated by Decree No. 12,651/2025) and pricing under CMED.

At federal legislation level, key regulatory agencies, particularly ANVISA, ANS, and CMED, play a decisive role through resolutions, normative instructions, and technical guidelines. Their agendas increasingly focus on risk-based regulation, digitalization, pricing controls, and post-market surveillance.

Recent developments further illustrate this landscape:

• The STF decision in ADI 5,529 eliminated automatic patent term extensions, significantly impacting pharmaceutical innovation and triggering litigation strategies around compensation.
• The introduction of new drug pricing frameworks (CMED Resolution No. 3/2025) and debates over pricing in judicialized supply cases reflect increased regulatory intervention in market access.
• Legislative changes such as Law No. 15,357/2026 (authorizing the sale of medicines in certain supermarket environments) demonstrate incremental but impactful adjustments in distribution rules.Overall, Brazil operates under a highly regulated, multi-layered system, where regulatory, pricing, IP, and litigation dynamics are deeply interconnected, requiring integrated legal strategies.

2. What three essential pieces of advice would you give to clients involved in Life Sciences Law?

(i) Anticipate and align IP and regulatory strategies from market entry
In Brazil, companies should reassess and structure their intellectual property strategies before entering the market, in close coordination with regulatory planning. In the post-ADI 5,529 scenario (where automatic patent term extensions are no longer available) early decisions on patent filing, prosecution, and lifecycle management are critical to preserving effective exclusivity. At the same time, proactive engagement with regulatory authorities (e.g., ANVISA and CMED) and public stakeholders is essential to navigate local requirements and ensure a smoother and more predictable market entry.

(ii) Integrate regulatory and pricing strategies from the outset
In Brazil, regulatory approval is not a standalone milestone. Market access depends on alignment with CMED pricing rules and SUS procurement dynamics, which must be mapped early to avoid value erosion and commercial misalignment.

(iii) Anticipate regulatory scrutiny and invest in compliance infrastructure
ANVISA’s trend toward risk-based oversight, digital monitoring, and post-market enforcement means that robust compliance programs (pharmacovigilance, GMP, traceability) are essential not only for approvals but for business continuity.

3. What are the greatest threats and opportunities in Life Sciences in the next 12 months?

• Regulatory and pricing pressure: Enhanced CMED frameworks and judicial scrutiny over drug pricing may compress margins and increase unpredictability.

Recent CMED reforms – including Resolution No. 3/2025 and subsequent adjustments such as Resolution No. 7/2026 – have significantly tightened Brazil’s drug pricing framework. Resolution No. 7 introduced targeted clarifications on key aspects of the new regime, including criteria for incremental innovation, documentation requirements (notably for biosimilars), and procedural rules for provisional pricing. However, it left relevant uncertainties unresolved, such as the potential use of off-label comparators, reinforcing the already stricter standards on therapeutic gain and international price referencing. Together, these measures are expected to compress margins, limit pricing flexibility, and increase uncertainty in market access. The industry has reacted negatively to this more restrictive and still evolving environment, raising concerns over legal certainty and economic viability, which already led CMED to postpone parts of the framework’s implementation. In this context, the combination of regulatory complexity, frequent rule changes (including Resolution No. 7), and significant economic impact is likely to intensify judicialization, with companies increasingly challenging pricing decisions, methodologies, and classifications before the courts, further amplifying unpredictability in the Life Sciences sector in the coming months.

• Patent cliff and IP uncertainty: Major patent expirations and the post-ADI 5,529 environment intensify competition, particularly in biologics and high-value therapies.
• Judicialization of healthcare: The continued expansion of court-ordered access to medicines creates budgetary and compliance pressures, especially for innovative products.

This trend is now being reshaped—though not reduced—by recent Supreme Court precedents. In Theme 6 (Appeal to the Brazilian Federal Supreme Court #566.471), the Brazilian Federal Supreme Court adopted a more restrictive approach, establishing that, as a rule, courts should not order the supply of medicines not incorporated into SUS lists, except in exceptional cases where strict cumulative criteria are met (e.g., lack of therapeutic alternatives, strong scientific evidence, proven necessity, prior administrative denial, and the patient’s inability to pay).

At the same time, Theme 1234 (Appeal to the Brazilian Federal Supreme Court #1,366,243) complements this framework by addressing jurisdiction, federal liability, and cost allocation in these disputes. The Brazilian Federal Supreme Court clarified when the Federal Government must be included as a defendant and established objective requirements – such as thresholds based on CMED price caps – to determine whether cases should be heard in federal or state courts, while also fostering inter-federative coordination and reimbursement mechanisms. Together, Themes 6 and 1234 aim to rationalize judicialization by introducing technical, evidentiary, and procedural constraints, but they are unlikely to eliminate litigation; rather, they are expected to shift disputes toward compliance with these criteria and procedural rules, sustaining high levels of judicial involvement in access to medicines.

Opportunities:

• Advanced therapies and innovation pipelines: Regulatory attention to ATMPs and novel products signals growth potential, particularly once pricing frameworks mature.
• Regulatory modernization and digitalization: ANVISA’s push for electronic submissions, faster reviews, and regulatory convergence improves predictability and reduces time-to-market.
• Industrial policy and public-private partnerships: SUS-linked initiatives (e.g., PDPs and local innovation partnerships) create avenues for local manufacturing and technology transfer.

4. How do you ensure high client satisfaction levels are maintained by your practice?

High client satisfaction in Life Sciences requires a combination of technical excellency, strategic thinking and anticipating steps, integration between different fronts of work, and responsiveness.

First, we adopt a multidisciplinary approach, combining regulatory, IP, litigation, and market access expertise to reflect the interconnected reality of the Brazilian system.

Second, we prioritize proactive advisory, anticipating regulatory and judicial trends, particularly in areas such as pricing disputes, patent enforcement, and compliance, rather than reacting to them.

Third, we invest in clear and business-oriented communication, translating complex regulatory developments into actionable strategies tailored to each client’s risk profile and commercial objectives.

Finally, close interaction with regulators and other stakeholders from the industry, associations and from the government, within ethical boundaries, allows us to remain aligned with regulatory expectations and evolving enforcement practices.

5. What technological advancements are reshaping Life Sciences Law and how can clients benefit from them?

Several technological trends are reshaping the legal and regulatory landscape:

(i) Digitalization of regulatory processes. ANVISA’s implementation of electronic submission systems, data traceability tools, and process automation is transforming regulatory timelines and transparency. Clients benefit from faster approvals and more predictable workflows, provided they adapt internal systems and governance structures accordingly.

(ii) Artificial intelligence across regulatory, compliance, and product development. Artificial intelligence is no longer limited to software as a medical device (SaMD), but increasingly embedded across the product lifecycle, from R&D and clinical development to regulatory submissions and post-market surveillance. This trend is prompting evolving regulatory approaches, including sandbox initiatives and risk-based frameworks. Clients that leverage AI strategically can optimize clinical trial design, enhance regulatory interactions, and strengthen compliance monitoring, while also anticipating scrutiny around algorithm transparency, data governance, and bias.

(iii) Data-driven compliance and pharmacovigilance. Advanced analytics and real-time monitoring tools enhance post-market surveillance, risk detection, and reporting capabilities. These technologies are becoming central to regulatory compliance in Brazil, particularly as authorities increase expectations around traceability and responsiveness.

(iv) Innovation in clinical research and real-world evidence. With the regulation of clinical research and growing acceptance of real-world data, companies can optimize development strategies, accelerate evidence generation, and strengthen pricing and reimbursement arguments.

In this evolving environment, clients that successfully integrate technology, regulatory strategy, and compliance will gain a significant competitive advantage in Brazil’s complex but highly promising Life Sciences market.

• 

  Eduardo Hallak

• 

  Juliana Neves

• 

  Juliana Libman

• 

  Lívia Maldi