Strategic Advisory · Brazil
How patients access
high-cost treatments
in Brazil — and what
it means for your company
In Brazil, regulatory approval does not determine patient access alone. There is a well-established judicial pathway — operating every day, at scale — that allows patients to obtain medications regardless of public or private coverage decisions.
The reality
Brazilian courts issue injunctions granting access to treatments within 24 to 48 hours — independently of any coverage policy.
The scale
Healthcare litigation is not an exception in Brazil. It is a structural part of how patients reach treatment — and has been for over two decades.
The gap
Most international companies have no visibility into this pathway — yet their products are often being accessed through it right now.
“What happens in practice is very different from what appears in regulation.”
Who this is for
Built for
international teams
operating in Brazil
If your company has a product on the Brazilian market — or is planning to enter — understanding the litigation landscape is not optional. It defines how patients actually access treatment, and it directly impacts market dynamics, pricing exposure, and regulatory strategy.
Market Access & Pricing teams
Trying to understand how products reach patients outside official incorporation — and what drives judicial demand at scale.
Regulatory Affairs leaders
Monitoring how court decisions interact with ANVISA approvals, CONITEC assessments, and ANS coverage mandates.
Legal & Compliance directors
Mapping legal exposure and obligations that arise when a product is being distributed under judicial orders.
Commercial & LATAM leadership
Building strategy for a market where litigation-driven demand is often larger — and less visible — than formally covered use.
The challenge
A complex scenario
most companies
misunderstand
Brazil’s healthcare litigation system creates a layer of market dynamics that does not appear in standard regulatory or commercial analysis. Ignoring it means making decisions without the full picture.
Invisible access pathways
Treatments reach patients through court orders — without formal incorporation into SUS protocols or ANS coverage lists. This volume is often invisible to international teams.
Regulatory data does not tell the full story
ANVISA approval or CONITEC rejection does not determine what happens on the ground. Courts operate on a different logic — and frequently override both.
Pricing and supply exposure
When judicial demand scales, companies face obligations — to government entities and private plans — that were not anticipated in commercial planning.
Strategy built on incomplete information
Market access, launch sequencing, and stakeholder engagement decisions are made without understanding the litigation dimension — which often drives the majority of real-world access.
How it works
The judicial access
pathway in Brazil
When a treatment is not covered — whether by SUS, a private health plan, or an employer-sponsored plan — patients in Brazil have a constitutional right to seek judicial access. Courts have consistently upheld this right for over two decades, and the volume of cases has grown into a structural feature of the healthcare system.
Speed
Injunctions granting immediate access to treatments are routinely issued within 24 to 48 hours of filing. The system is designed to move fast when health is at risk.
Scope
Both public (SUS) and private (health plans) defendants are subject to judicial orders. Federal, state, and municipal governments can be held jointly liable.
Legal anchor
The right to health is enshrined in the Brazilian Constitution (Art. 196). The STF and STJ have established binding precedents that consistently support patient access claims.
01
Prescription
A physician prescribes a treatment that is not covered — either by SUS protocols or by the patient’s private health plan.
→
02
Legal Action
The patient files a lawsuit — often with the support of a public defender or private attorney — requesting urgent judicial access to treatment.
→
03
Injunction
A judge issues an emergency order requiring the health system or insurer to provide the treatment — typically within 24 to 48 hours of the ruling.
→
04
Treatment Access
The patient receives the medication or procedure under judicial order — entirely outside the standard coverage and incorporation process.
→
What we offer
Advisory services
grounded in active practice
Entry point · Fixed fee
Diagnostic Report
A structured overview of Brazil’s healthcare litigation landscape, tailored to your therapeutic area. The clearest way to understand the system as it actually operates — not as it appears in policy documents.
- How SUS and private plans are structured
- Role and real scale of judicial access
- Key barriers and strategic opportunities
- PDF report (10–15 pages) + 1h briefing call
Specialized · Project-based
Litigation Access Mapping
A detailed analysis of how a specific drug or treatment category is accessed through the courts in Brazil — including the legal arguments courts accept, decision patterns, and risk exposure for manufacturers.
- How patients access via judicial order
- Accepted legal arguments and precedents
- Court decision profile and regional variation
- Risk and opportunity assessment per product
Ongoing · Monthly retainer
Strategic Advisory
Continuous legal intelligence for teams that need reliable, practice-based insights on Brazil’s evolving litigation and regulatory landscape — delivered monthly, with priority access for specific queries.
- Monthly legal and regulatory updates
- Court decision trends and STJ/STF developments
- Strategic support for market access teams
- Priority response to time-sensitive questions
Scalable · Remote
Training & Workshop
A structured session for international teams — legal, regulatory, market access, or commercial — who need to understand Brazil’s healthcare litigation system with depth and practical clarity.
- 1–2h session via Zoom
- Full system overview with real case context
- Q&A with an attorney actively litigating cases
- Custom focus available per team and product area
“We represent patients in complex healthcare access cases every day. That is the basis of everything we know — and everything we advise.”
Who we are
A firm built
exclusively on
health law
Felipe Corrêa da Silva
OAB/RS 82.728 · Partner
Specialized in health law litigation, with active cases involving access to high-cost medications, oncological treatments, genetic diagnostics, and home care. Advises on litigation strategy and judicial access dynamics across federal and state courts in Brazil.
Janine Martins Corrêa da Silva
OAB/RS 69.990 · Partner
Co-founder and partner, with deep expertise in health plan litigation, SUS access cases, and regulatory frameworks governing healthcare coverage in Brazil. Active in both Porto Alegre and São Paulo.
Martins, Corrêa da Silva Advogados practices exclusively in health law — with offices in Porto Alegre and São Paulo. Our advisory for international companies is grounded in the same cases we litigate for patients every day.
Let’s talk
After one conversation,
you will understand
how your treatment reaches patients in Brazil
We offer an initial conversation to map what you already know, identify the gaps, and clarify whether and how our advisory can help your team.
No sales pitch. No commitment. One focused conversation.