MEDIA & PUBLICATIONS

1. Please briefly summarize your country's legislative framework for medicinal products (including biologicals), medical devices, food, and food supplements

Brazil adopts a centralized and highly structured federal regulatory framework for life sciences products, primarily grounded in Law No. 6,360/1976 (sanitary control of products and marketing authorization) and Law No. 9,782/1999 (creation of the National Health Surveillance System – ANVISA), complemented by Decree No. 8,077/2013, and Law No. 6,437/1977 (administrative sanctions).

Medicinal products (including biological ones) follow a similarly comprehensive regulatory matrix, mainly grounded on ANVISA’s Resolutions of the Board of Directors (RDCs). RDC No. 658/2022 establishes general good manufacturing practices requirements, while additional RDCs govern specific product categories and lifecycle stages, including innovative drugs, generics, biologics, biosimilars, radiopharmaceuticals and advanced therapy products. The framework also addresses labelling, pharmacovigilance, clinical research, importation and advertising. Regulatory obligations vary depending on the product category and stage of the lifecycle.

Especially regarding biologicals, it is also worth noting that advanced therapies and genetically modified organisms (GMOs) – may be subject to a parallel biosafety framework governed primarily by Law No. 11,105/2005 (Biosafety Law), its implementing Decree No. 5,591/2005, and regulations issued by the National Technical Biosafety Commission (CTNBio).

This regime establishes safety rules and oversight mechanisms for activities involving GMOs across their entire lifecycle, including research, production, transport, environmental release, and commercialization, based on the protection of human, animal and plant health and the environment, as well as the precautionary principle – complementing ANVISA’s role where GMOs intersect with health-regulated products.

In this context, CTNBio acts as the central technical authority responsible for risk assessment and regulatory decisions concerning biologicals, issuing binding technical opinions that are required prior to environmental release or commercial use, mainly based on (i) Normative Resolution No. 18/2018, which establishes the risk classification of GMOs and corresponding biosafety levels, defining containment requirements and risk assessment methodologies applicable to research and development activities; (ii) Normative Resolution No. 32/2021, which provides rules for the commercial release and post-market monitoring of genetically modified plants and animals, requiring prior CTNBio approval and case-by-case risk assessment, including hazard identification, exposure assessment, and risk characterization; (iii) Normative Resolution No. 37/2022, which governs the issuance of the Biosafety Quality Certificate, which is mandatory for institutions conducting activities with GMOs, and (iv) Normative Resolution No. 40/2024, which refines technical criteria for biosafety levels and containment measures.

Medical devices are regulated through an extensive set of ANVISA’s RDCs, notably RDC No. 751/2022 – which provides for risk classification and regulatory pathways – and RDC No. 665/2022, providing for good manufacturing practices. The regulatory framework covers all aspects of the product lifecycle, including labelling and instructions for use, clinical investigations, post-market surveillance, field safety corrective actions, software as a medical device (SaMD), advertising, unique device identification (UDI), and special access pathways such as notification regimes and compassionate use. These rules are further detailed through normative instructions and technical guidance.

Clinical research in Brazil is governed by a dual system combining ethical and regulatory oversight: before ANVISA approval, studies must be reviewed by the Research Ethics Committee system (CEP/CONEP) under CNS Resolution No. 466/2012, ensuring ethical compliance, informed consent, and protection of participants; depending on complexity, protocols may require national-level CONEP review. In parallel, ANVISA authorizes clinical trials under its own regulations (e.g. RDC No. 9/2015), covering technical and safety requirements, with approval typically conditioned on prior or coordinated ethical clearance. Additionally, the Federal Council of Medicine (CFM) provides professional ethical oversight, reinforcing investigators’ duties. This creates a coordinated framework in which ethical review, regulatory authorization, and professional accountability operate jointly to ensure participant protection and scientific integrity.

Food and food supplements are regulated under the same overarching sanitary legislation but are subject to specific ANVISA rules. Food supplements, in particular, are governed by RDC No. 243/2018 and related normative instructions, which establish permitted ingredients, safety standards, functional claims and labelling requirements, typically under a risk-based notification system. In addition, the Ministry of Agriculture and Livestock (MAPA) plays a complementary role in the regulatory framework, particularly with respect to the oversight of agricultural inputs and raw materials (including plant- and animal-derived ingredients), as well as the inspection and certification of establishments involved in the primary production and processing stages. As a result, companies marketing food supplements must ensure compliance not only with ANVISA’s sanitary requirements but also with applicable MAPA regulations governing the production chain, quality control, and traceability of ingredients where relevant.

Pricing and reimbursement are separately regulated. Drug pricing is controlled under Law No. 10,742/2003, implemented by the Pharmaceutical Market Regulation Chamber (CMED), with ANVISA acting as its executive secretariat. Public reimbursement decisions are informed by the National Committee for the Incorporation of Technologies in the SUS (CONITEC), established by Law No. 12,401/2011, which conducts health technology assessments (HTAs) for incorporation into the public healthcare system.

From an institutional perspective, ANVISA acts as the central federal authority responsible for product registration, company authorizations, GMP certification, border control and post-market surveillance. State and municipal health authorities operate within the National Health Surveillance System (SNVS), handling local licensing and inspections without hierarchical subordination to ANVISA. CMED is an interministerial body responsible for setting price caps, while CONITEC functions as an advisory entity within the Ministry of Health.

2. With regards to medicinal products and medical devices, how is the regulatory process structured in your jurisdiction from R&D through market approval until post-marketing vigilance, and what rules does it follow? Please briefly describe.

In Brazil, the regulatory process for medicinal products and medical devices is structured as a life cycle-based system governed primarily by ANVISA through a detailed framework of Resolutions of the Board of Directors (RDCs), complemented by laws such as Law No. 6,360/1976 and Decree No. 8,077/2013. The lifecycle typically comprises four main stages: (i) research and development (R&D), (ii) clinical investigation, (iii) marketing authorization, and (iv) post-market surveillance.

During the R&D and preclinical stage, products must comply with applicable laboratory and ethical standards. The subsequent clinical phase requires prior approvals from ANVISA and ethics committees, following good clinical practices.

For medicinal products, a similarly comprehensive regulatory matrix applies. RDC No. 658/2022 establishes general good manufacturing practices requirements, while multiple other RDCs govern specific regulatory pathways and technical requirements. These include (i) distinct registration pathways for new drugs, generics, biologics, biosimilars, radiopharmaceuticals and advanced therapy products, (ii) requirements for stability studies, (iii) bioavailability and bioequivalence testing, (iv) dissolution and quality control standards, (v) labelling and package inserts, (vi) pharmacovigilance obligations, (vii) rules for controlled substances, (viii) clinical research requirements, (ix) importation procedures, (x) serialization and traceability systems advertising and promotion controls, (xi) regulatory obligations are product-specific and evolve throughout the lifecycle, requiring ongoing compliance adjustments post-approval.

The marketing authorization stage involves ANVISA’s review of safety, efficacy and quality data. Approval timelines depend on product category and regulatory pathway. Once approved, companies must ensure compliance with manufacturing standards, including GMP certification.

Finally, the post-marketing phase is characterized by robust surveillance obligations, including pharmacovigilance (for medicines) and technovigilance (for devices), adverse event reporting, product recalls, and ongoing regulatory maintenance such as variations, renewals and compliance audits.

For medical devices, the regulatory framework is risk-based and anchored in key RDCs such as RDC No. 751/2022 (classification and regulatory pathways) and RDC No. 665/2022 (good manufacturing practices). The regulatory scope encompasses all critical aspects of the product lifecycle, including: (i) dossier content and technical documentation, (ii) labelling and instructions for use requirements, (iii) clinical investigations and performance evaluation for in vitro diagnostics, (iv) post-market surveillance and technovigilance systems, (v) field safety corrective actions, (vi) regulation of software as a medical device, (vii) sterilization standards and validation, (viii) import licensing procedures, (ix) advertising restrictions, (x) unique device identification systems, (xi) special regulatory pathways, such as notification regimes and compassionate use.

These rules are supplemented by normative instructions and technical guidance documents, which provide operational detail and regulatory interpretation.

Overall, Brazil’s system reflects a comprehensive, risk-based and lifecycle-oriented regulatory model, increasingly aligned with international standards while maintaining strong local oversight.

3. What is the regulatory process for food supplements, from first notification to the competent authorities until post-marketing vigilance in your country, and what regulations are applicable here? Please briefly describe.

Food supplements in Brazil are regulated by ANVISA under a risk-based framework, primarily set by RDC No. 243/2018 and complementary normative instructions. Most products are subject to a prior notification regime, provided that ingredients, dosages and claims strictly comply with ANVISA’s positive lists. Products outside these parameters may require formal registration.

The process typically involves confirming product classification as a supplement, ensuring that ingredients and claims are authorized, preparing compliant labelling, and filing an electronic notification before commercialization.

Although ANVISA is the primary authority for food supplements, the regulatory process must be understood within a broader, shared competence framework involving the Ministry of Agriculture and Food Supply (MAPA). In Brazil, food regulation is divided between health and agricultural authorities, with responsibilities allocated depending on the nature of the product and the stage of the production chain.

MAPA plays a key role in overseeing earlier stages of the food supply chain, including agricultural production, raw materials, and products of animal origin (such as dairy-derived ingredients, proteins, or other inputs that may be used in supplements), as well as beverages and certain plant products. It is responsible for sanitary inspection, certification of production establishments (e.g. under the Federal Inspection Service – SIF), and ensuring compliance with quality and safety standards at the primary production level.

In practice, this means that manufacturers of supplements must ensure that their ingredients and supply chains comply not only with ANVISA’s requirements but also with MAPA regulations where applicable, particularly where animal-derived or agricultural inputs are involved. Additionally, depending on the product format or classification (e.g. certain beverages or products at the borderline between food categories), MAPA may have direct regulatory competence or concurrent oversight.

Post-marketing, companies must comply with ongoing safety monitoring and regulatory compliance obligations, including cooperation with inspections and corrective measures (e.g., recalls). At this stage, oversight may also involve both ANVISA and MAPA, as sanitary surveillance authorities are responsible for monitoring products in the marketplace, while agricultural authorities may continue to supervise production establishments and supply chain compliance.

Despite the streamlined framework, studies indicate significant compliance challenges, including misclassification and widespread use of unauthorized claims, particularly in online sales channels, reinforcing ANVISA’s increasing focus on post-market surveillance and enforcement.

Overall, the Brazilian approach combines facilitated market entry with strengthened ex post control, within a multi-authority system in which ANVISA leads the regulation of food supplements, while MAPA plays a complementary role in ensuring the safety, quality and traceability of agricultural inputs and certain categories of food products.

4. What are the ongoing obligations in your country after a marketing authorization for medicinal products has been obtained or a conformity assessment been carried out for medical devices?

In Brazil, ANVISA marketing authorization entails continuous lifecycle obligations for both medicinal products and medical devices, focused on maintaining quality, safety and performance.

For medicinal products, authorization holders must implement a pharmacovigilance system in accordance with RDC No. 406/2020, including adverse event reporting, periodic safety updates and risk minimization measures.

For medical devices, companies must maintain a technovigilance system under RDC No. 67/2009, covering detection, assessment and prevention of adverse incidents associated with device use.

Across both categories, key ongoing obligations include:

• compliance with Good Manufacturing Practices (GMP);
• adherence to Good Distribution and Storage Practices (GDSP);
• implementation of traceability systems, enabling tracking of products throughout the supply chain and supporting recall and risk management actions;
• maintenance of pharmacovigilance (for medicines) and technovigilance (for devices) systems, including timely reporting of adverse events and safety signals;
• continuous post-registration maintenance, ensuring that the marketing authorization remains valid and up to date (e.g. periodic renewals where applicable and submission of updated quality, safety and efficacy data);
• management of post-approval changes (variations for medicines and post-regularization changes for devices);
• continuous updating of regulatory documentation and labelling.
• monitoring of product shelf life and stability, including the obligation to assess and report adverse events potentially associated with product degradation or expiration, as part of lifecycle safety surveillance.

In addition, ANVISA may impose conditional post-marketing requirements, reflecting its broad sanitary enforcement powers. These may include:

• medicines: post-marketing commitments such as Phase IV clinical trials, particularly where uncertainties remain regarding safety or efficacy;
• medical devices: enhanced post-market monitoring, clinical follow-up studies for high-risk devices (under RDC No. 751/2022) and field safety corrective actions.

Overall, the Brazilian framework imposes robust post-marketing compliance obligations, with increasing regulatory scrutiny throughout the product lifecycle.

5. Which are the competent national authorities having the regulatory oversight over medicinal products, medical devices, food, and food supplements and what are their respective responsibilities?

Brazil’s regulatory oversight in life sciences is primarily centralized at the federal level, with the Ministry of Health acting as the main authority.

Under the Brazilian constitutional framework, health is a universal, public, and unrestricted right. In this context, the Ministry of Health plays a central and overarching role as the primary policymaking and coordinating authority for medicinal products and medical devices, particularly within the Unified Health System (SUS). The Ministry is responsible for defining national health policies, determining which technologies and medicines will be incorporated into the public system, overseeing access strategies, and ensuring the supply of treatments – including, where applicable, through judicial or administrative pathways within the SUS. It also plays a key role in pricing and funding policies, alongside other bodies.

ANVISA, in turn, is responsible for marketing authorizations, GMP certification, sanitary inspections, imports/exports control and post-market surveillance.

State and municipal health authorities operate within ANVISA and are responsible for local licensing, inspections and first-instance administrative enforcement, acting in coordination with ANVISA but without hierarchical subordination.

CMED (Pharmaceutical Market Regulation Chamber) is responsible for drug price regulation, setting maximum prices under Law No. 10,742/2003, while CONITEC advises the Ministry of Health on reimbursement and incorporation decisions within the public healthcare system (SUS), based on health technology assessments.

From an institutional standpoint:

• The Ministry of Health acts as the principal authority in defining public health policies, incorporation of technologies, and overall regulatory strategy for medicinal products and medical devices within the SUS;
• SNVS authorities (state and municipal) act in a decentralized manner, without hierarchical reporting to ANVISA;
• ANVISA is a special-regime autarchy, with enhanced autonomy, fixed-term directors and partial fee-based funding, formally linked to but functionally independent from the Ministry of Health;
• Health Surveillance System authorities (state and municipal) act in a decentralized manner, without hierarchical reporting to ANVISA;
• CMED is an interministerial collegiate body without separate legal personality; and
• CONITEC operates as a permanent advisory body within the Ministry of Health.

Together, these entities form a multi-layered regulatory system, combining centralized technical regulation with decentralized enforcement and policy decision-making.

6. Please briefly describe the procedure of challenging regulatory decisions (e.g., denial of marketing authorization) made by the competent regulatory authority in relation to medicinal products, medical devices, and food supplements.

In Brazil, challenges to regulatory decisions in the life sciences sector primarily involve contesting individual administrative acts issued by ANVISA or other authorities within the National Health Surveillance System. These typically include refusals or restrictions in marketing authorizations or device regularization, technical requirements during review, GMP-related findings, post-market measures (e.g., suspensions, recalls or field actions), and administrative penalties.

The primary avenue is administrative review within the issuing authority. In ANVISA proceedings, companies may submit appeals within the same administrative case, potentially escalating to higher internal instances and, depending on the matter, to ANVISA’s Collegiate Board. In sanctioning cases, challenges begin with a formal defense followed by successive administrative appeals.

Admissibility generally requires:

• standing (directly affected party),
• timely filing, and
• a reasoned submission setting out legal and technical grounds (e.g., illegality, procedural defects, lack of reasoning or disproportionality), supported by evidence.

In parallel to (and independently from) the administrative route, affected parties may seek immediate judicial review before Brazilian courts, most commonly through a writ of mandamus to challenge unlawful or abusive administrative acts. The Brazilian judiciary is highly familiarized to reviewing administrative decisions, including those issued by regulatory agencies such as ANVISA, and there is a well-established practice of litigating the validity, legality, and proportionality of such acts.

Importantly, there is no general requirement to exhaust administrative remedies before resorting to the courts, and it is common for judicial proceedings to run in parallel with ongoing administrative challenges. In many cases, Plaintiffs seek preliminary injunction which may be granted to suspend the effects of the challenged decision (e.g., denial of a marketing authorization or enforcement measure) where there is a likelihood of success on the merits and risk of irreparable harm.

Such judicialization does not typically trigger negative consequences within the administrative sphere, and the administration is institutionally accustomed to having its acts reviewed by the judiciary.

These mechanisms are broadly consistent across regulated products (including food supplements), as they stem from general administrative due process principles, with variations mainly reflecting product-specific technical rules rather than differences in review pathways.

7. Please briefly describe the legal framework and the relevant regulatory procedure (e.g., application process, requirements, approval, denial) that applies in your jurisdiction to clinical trials for medicinal products and medical devices.

Clinical trials in Brazil are governed by a dual oversight system, combining ethical review and sanitary approval by ANVISA. The framework was recently strengthened by Law No. 14,874/2024, regulated by Decree No. 12,651/2025, which reorganizes the national research ethics system and aims to increase legal certainty and foster investment. Until the new central ethics body becomes operational, the existing CEP/CONEP system remains in place.

Ethics approval and ANVISA review are independent and conducted in parallel, but clinical trials may only commence once both approvals are granted.

For medicinal products (including biologics), the core ANVISA framework is RDC No. 945/2024, structured around:

• the Clinical Development Dossier (DDCM) and trial-specific dossier (DEEC)
• submission of key documentation (e.g., clinical development plan, investigator’s brochure, quality data and statistical analysis plan)
• ongoing obligations such as safety reporting, protocol amendments and lifecycle management
• import procedures for investigational products, supported by prior ANVISA authorization

For medical devices, clinical investigations are governed by RDC No. 837/2023, adopting a risk-based approach:

• higher-risk devices (Classes III and IV) generally require prior ANVISA approval through a Clinical Investigation Dossier (DICD);
• lower-risk devices (Classes I and II) typically do not require prior ANVISA review and proceed based on ethics approval and compliance with Good Clinical Practices.

Overall, the Brazilian framework reflects an evolving system that seeks to streamline approvals while maintaining robust ethical and regulatory oversight, with increasing emphasis on efficiency, predictability and international alignment.

8. Is there a public database for clinical trials in your country, and what are the rules for publication?

Yes. Clinical trials involving medicinal products and medical devices in Brazil are subject to mandatory registration in publicly accessible databases, with transparency requirements applying throughout the study lifecycle.

Under Law No. 14,874/2024, all clinical research involving human subjects must be registered in a public platform integrated with the national ethics system, with information kept up to date during the trial.

From a regulatory standpoint, ANVISA RDC No. 837/2023 requires that clinical investigations involving medical devices be registered in databases recognized by the WHO International Clinical Trials Registry Platform (ICTRP) or the International Committee of Medical Journal Editors (ICMJE) as a condition for regulatory approval.

In practice, public databases (such as ReBEC) provide access to high-level structured information, including sponsor identification, investigational product or device, general study design and recruitment status. However, Brazilian rules do not require full public disclosure of sensitive documents, such as full protocols, investigational dossiers or complete clinical study reports, which remain protected as confidential and trade secrets.

Importantly, the level of publicity of clinical trial data is expressly limited. Only summary and non-sensitive information is made publicly available, while confidential business information, proprietary data, and personal data – especially sensitive personal data relating to health – must not be disclosed. This restriction is reinforced by Brazil’s General Data Protection Law (LGPD), which imposes strict rules on the processing and disclosure of personal data, particularly in the health context, and by administrative secrecy rules applicable to regulatory submissions.

Law No. 14,874/2024 also addresses the return of results to participants, typically through study-specific communication and informed consent processes. Broader public dissemination of results depends on registry requirements, journal policies and sponsor practices, always subject to confidentiality and data protection (LGPD) obligations.

Overall, Brazil adopts a model of restricted transparency, ensuring public visibility of key trial information while preserving commercially sensitive data.

9. Please briefly summarize the rules that must be observed in your jurisdiction when using data from clinical trials?

In Brazil, the use of clinical trial data is governed by a combination of data protection law (LGPD – Law No. 13,709/2018) and ethical/regulatory rules applicable to human research, notably Law No. 14,874/2024 and CNS Resolution No. 738/2024.

Clinical trial datasets will generally qualify as personal data and, in most cases, as sensitive personal data (health, genetic or biometric data), requiring enhanced safeguards. In practice, data is typically maintained in coded (pseudonymized) form, as full anonymization is rarely feasible during the study due to traceability requirements (e.g., audits, safety follow-up and inspections).

The key compliance requirements include:

• ensuring a valid legal basis under the LGPD (typically research-related grounds), combined with adherence to ethical approvals and informed consent;
• implementing strict governance, security and access controls, particularly for sensitive data;
• limiting data sharing to anonymized or coded datasets, with the re-identification key retained by the data manager, in line with Law No. 14,874/2024;
• ensuring that any data transfers (including to affiliates or CROs) are foreseen in the protocol, justified, and subject to appropriate contractual and technical safeguards;
• complying with international transfer rules under Articles 33–36 of the LGPD, where data is transferred abroad (e.g., adequacy decisions or contractual mechanisms).

In addition, Law No. 14,874/2024 itself expressly establishes confidentiality obligations over clinical trial data and documentation. The law provides that information submitted within the context of clinical research – particularly proprietary data, commercially sensitive information, and personal data of participants – must be treated as confidential by authorities and other parties with access to it, and may only be disclosed to the extent necessary to fulfil regulatory, ethical, or public health purposes. This reinforces the protection of trade secrets and ensures that clinical development data cannot be publicly disclosed or shared indiscriminately.

Besides that, research databases must comply with specific governance requirements under CNS Resolution No. 738/2024, including prior ethics review where a database is created or reused, and clear definition of data controllers, categories of data, sharing rules and security measures.

Overall, the Brazilian framework imposes strict data governance standards, combining privacy law with research ethics requirements, with a strong emphasis on confidentiality, controlled access and risk-based data management.

10. Are there any trends and/or legislative proposals in your country on digitizing the process of conducting clinical trials (e.g., digitalization of the application process, decentralization of clinical trials)?

Brazil is increasingly moving towards digitalization and modernization of clinical trials, particularly following the enactment of Law No. 14,874/2024 and its regulation by Decree No. 12,651/2025, which aim to streamline procedures and increase efficiency.

Brazilian regulations do not prohibit the use of digital or decentralized tools in clinical trials. Instead, their use is assessed on a case-by-case basis within the existing regulatory and ethical framework, provided that participant protection, data integrity and inspection readiness are ensured.

In practice:

• Digital recruitment tools (e.g., social media campaigns, online pre-screening, landing pages) are permitted, but are treated as participant-facing materials, requiring prior ethics approval and full alignment with approved protocols, including safeguards against misleading information and undue influence.
• eConsent platforms may be used, provided they comply with informed consent requirements and are approved by the relevant ethics committee (CEP/CONEP).
• Remote and decentralized trial elements (e.g., telemedicine visits, wearable devices, electronic case report forms (eCRFs) and remote monitoring) are also permitted, as long as they are clearly described in the protocol and supporting documentation.

With respect to artificial intelligence (AI), there is no specific, standalone regulatory framework governing its use in clinical trials in Brazil. However, its use is not prohibited and is already emerging in practice, particularly in areas such as patient recruitment, data analysis, risk monitoring, protocol optimization, and the management of large datasets. The use of AI is therefore subject to the same general requirements applicable to clinical research, including Good Clinical Practice (GCP), data integrity, transparency, explainability (where relevant), and ethical oversight by CEP/CONEP and ANVISA.

Importantly, there is growing regulatory and academic discussion in Brazil حول the risks associated with AI, including algorithmic bias, discrimination, and potential reinforcement of structural inequalities, including racial bias. These concerns are particularly relevant in the Brazilian context, given the country’s demographic diversity and historical inequalities in access to healthcare. Ethics committees and regulators increasingly expect sponsors to address such risks – especially where AI tools are used in decision-making processes that may affect participant selection, treatment allocation, or data interpretation.

Although these discussions are still evolving and not yet fully codified into binding clinical trial regulations, they are reflected in broader Brazilian legal and policy debates on AI governance, data protection (under the LGPD), and research ethics, which emphasize non-discrimination, fairness, transparency, and accountability.

In summary, sponsors and investigators must ensure confidentiality and secure data handling; controlled access and traceability of electronic records; and auditability and inspection readiness for ANVISA and ethics authorities.

Overall, while Brazil does not yet have a fully dedicated regulatory framework for decentralized trials, the current system already allows for progressive adoption of digital tools, provided compliance with existing Good Clinical Practice, data protection and ethical rules is maintained.

11. What are your country's legal requirements for the authorization of manufacturing plants for medicinal products, medical devices, food, and food supplements? Please briefly describe.

In Brazil, manufacturing plants for medicinal products and medical devices must obtain a Company Operating Authorization (AFE) from ANVISA prior to commencing operations. The AFE is granted following an electronic application, which must include corporate information, identification of activities and product categories, technical responsible personnel, proof of payment of regulatory fees, and evidence of compliance (typically via an inspection report or valid sanitary license issued by local health authorities – VISA).

The AFE authorizes specific activities, which may include manufacturing and related operations such as storage, distribution, packaging, repackaging, fractioning, dispatch and import for own use. Its effectiveness begins upon publication in the Official Gazette, and it remains valid indefinitely, provided regulatory requirements are maintained and changes are properly notified.

For both medicines and medical devices, compliance with Good Manufacturing Practices (GMP) is a key requirement. ANVISA issues GMP certificates (cGMP) per manufacturing site based on inspections and risk-based evaluations. For pharmaceuticals and APIs, GMP certification is effectively a prerequisite for product registration and commercialization. For medical devices, ANVISA may rely on MDSAP audit reports to streamline GMP certification.

Where activities involve controlled substances, additional special authorization (AE) is required, aligned with the scope of controlled activities.

GMP certificates are generally valid for two years, although for device manufacturers participating in MDSAP, ANVISA may extend validity to four years, subject to continued compliance and ongoing audits.

For food and food supplements, the regulatory framework primarily falls under the Ministry of Agriculture and Food Supply (MAPA) and, depending on the product classification, ANVISA. In general, establishments dealing with products of animal origin (such as certain food supplements containing animal-derived ingredients) must be registered with MAPA and are subject to prior inspection and approval under the Federal Inspection Service. This includes evaluation of facilities, equipment, operational procedures, and compliance with applicable sanitary and technological standards.

For plant-based foods and most food supplements, prior authorization of the manufacturing plant is typically not required at the federal level; however, facilities must be duly licensed by local sanitary authorities and comply with Good Manufacturing Practices and general food safety regulations. MAPA and ANVISA both exercise oversight through inspections and enforcement actions, ensuring ongoing compliance with hygiene, traceability, and labeling requirements.

Overall, Brazil applies a rigorous, inspection-based authorization model, with strong emphasis on manufacturing quality and regulatory traceability.

12. Please briefly describe the typical process of distributing medicinal products, medical devices, and food supplements in your country, encompassing, if applicable, the wholesale distribution of products.

Distribution in Brazil requires that all entities involved in wholesale activities (including warehouses and distributors) obtain an ANVISA Company Operating Authorization (AFE) prior to commencing operations.

The AFE is granted upon an electronic application supported by corporate documentation, designation of a technically responsible professional, proof of fee payment, and an inspection report or valid sanitary license issued by the local health authority (VISA) confirming compliance with applicable Good Distribution and Storage Practices (GDSP).

For medical devices, the AFE is issued per establishment, meaning each warehouse or distribution center must hold its own authorization. For pharmaceuticals, a central AFE may cover multiple branches, although each branch must maintain its own local license and remain compliant.

The authorized scope typically includes storage and wholesale distribution, and may be expanded to cover activities such as transport, import, export, packing and repacking, subject to additional filings. Where controlled substances are handled, a separate Special Authorization (AE) is required.

The AFE becomes effective upon publication in the Official Gazette and remains valid indefinitely, provided the company maintains compliance and updates its records with ANVISA as needed.

While a formal certificate of Good Distribution and Storage Practices (cGDSP) exists, it is not a legal prerequisite for operation. However, compliance with GDSP is mandatory and subject to inspection, particularly under RDC No. 430/2020 (medicines) and RDC No. 665/2022 (medical devices).

Overall, distribution in Brazil is subject to a regulated and inspection-driven framework, with strong emphasis on traceability, storage conditions and supply chain integrity.

13. Please briefly describe the pricing and reimbursement rules, if any, for medicinal products, medical devices, and food supplements in your jurisdiction?

In Brazil, pricing and reimbursement are highly structured for pharmaceuticals, but significantly less regulated for medical devices.

For medicinal products, prices are subject to statutory control under Law No. 10,742/2003, administered by CMED. The framework establishes binding price ceilings, including:

• PF (ex-factory price) for manufacturers/importers
• PMC (maximum retail price) for pharmacies
• PMVG (government sales price), which applies a mandatory discount for public procurement and court-ordered supply

Companies may negotiate discounts but cannot exceed CMED ceilings. Entry pricing is currently governed by CMED Resolution No. 3/2025, which modernized the system by introducing a category-based methodology supported by a Pricing Information Document (DIP) and reinforcing external reference pricing, based on a basket of international markets. Pricing approvals may initially be provisional where sufficient international benchmarks are not available.

For medical devices and IVDs, there is no nationwide price cap regime. Pricing is largely market-driven, although influenced by public procurement rules, competition law and transparency initiatives (e.g., ANVISA price monitoring under RDC No. 478/2021).

With respect to reimbursement, Brazil operates primarily through the public healthcare system (SUS), which procures and provides products directly, rather than reimbursing patients.

For medicines, access is structured through national programs and depends on incorporation decisions based on HTAs conducted with CONITEC support, reflected in public formularies such as RENAME.

For medical devices, funding follows a procedure-based model, where hospitals are reimbursed based on national tariffs (SIGTAP), and devices are acquired within those packages.

An important feature of the Brazilian system is the judicialization of healthcare, whereby courts may order public authorities to supply medicines or devices outside standard reimbursement pathways, including high-cost or non-incorporated therapies, subject to specific criteria.

Overall, Brazil’s framework combines strict price control for pharmaceuticals, procurement-driven reimbursement, and limited direct regulation for devices, with growing emphasis on transparency and health technology assessment.

14. What legislative framework applies to the advertising for medicinal products, medical devices, and food supplements in your country?

Advertising in the Brazilian life sciences sector is governed by a combination of Law No. 6,360/1976, the Consumer Protection Code, and detailed ANVISA regulations, notably RDC No. 96/2008, as well as product-specific RDC frameworks.

For medicinal products, advertising of medicinal products is primarily governed by ANVISA Resolution RDC No. 96/2008, which applies to all forms of communication intended to promote or influence the prescription, dispensing or use of medicines, reflecting a public health-oriented and highly restrictive approach. The framework establishes a clear distinction between prescription-only medicines, which may only be advertised to healthcare professionals, and over-the-counter (OTC) products, which may be directed to the general public. Advertising must be truthful, evidence-based and strictly aligned with the approved label, and it is prohibited to include misleading claims, induce irrational use, or use persuasive tactics such as imperative language or unauthorized endorsements.

For medical devices, advertising is also governed within a comprehensive ANVISA regulatory framework based on Law No. 6,360/1976 and RDCs No. 751/2022 and RDC No. 665/2022. The scope of regulation extends beyond advertising to include product classification, dossier requirements, labelling/IFU standards, clinical investigations, post-market vigilance, and import controls. Promotional materials must be consistent with the approved intended use, technical documentation and regulatory status, and cannot be misleading or exceed authorized claims.

For food supplements, advertising is regulated under general consumer protection rules and specific ANVISA provisions, particularly those governing authorized health claims and labelling (RDC No. 243/2018). Claims must be substantiated and limited to those permitted by ANVISA, with a prohibition on therapeutic or medicinal claims.

15. What laws apply to patents and trademarks for medicinal products, medical devices, and food supplements in your country?

Intellectual property in Brazil is primarily governed by Law No. 9,279/1996 (Brazilian Patent Statute – BPS), which regulates both patents and trademarks and applies uniformly across the life sciences sector, including medicinal products, biologicals, medical devices and food supplements.

With respect to patents, the same legal framework applies across all these sectors, with no substantive distinction based on the type of product. Patentability is subject to the general requirements of novelty, non-obviousness and industrial application. The Brazilian Patent and Trademark Office (BRPTO) has exclusive jurisdiction to examine patent applications and assess compliance with these criteria.

Although ANVISA retains broad regulatory authority over the safety, efficacy and commercialization of medicinal products, medical devices and food supplements, its role is clearly separated from the granting of intellectual property rights.

In relation to trademarks, the BPS also governs registration and protection, with the BRPTO responsible for granting exclusive rights. Trademark protection is particularly relevant in the life sciences and food sectors due to (i) the need to avoid confusion in product names, especially for medicines and certain regulated food supplements; (ii) regulatory scrutiny by ANVISA of proprietary names for medicinal products, and applicable food regulations to prevent misleading claims in food supplements; and (iii) the interaction between trademark law, labeling rules, branding strategies and advertising restrictions applicable to medicines, medical devices and food products.

For food supplements, in addition to trademark protection under the BPS, branding and product presentation must comply with ANVISA’s regulatory framework on foods (including RDC No. 243/2018 and related normative acts), which may indirectly impact the use of certain marks, particularly where they suggest therapeutic effects or could mislead consumers.

Overall, Brazil offers a unified and relatively robust IP framework across medicinal products, medical devices and food supplements, combining centralized IP protection with strict regulatory oversight over product safety, labeling and marketing practices.

16. Please briefly describe how patent infringements in relation to medicinal products and medical devices are addressed in your jurisdiction, including possible defense strategies and legal proceedings against patent infringements.

Patent infringement in Brazil is primarily addressed through civil litigation before state courts, under the BPS and the Brazilian Code of Civil Procedure. This is particularly relevant in the pharmaceutical and medical device sectors, where disputes often arise between originators and generics/biosimilars.

Plaintiffs frequently seek preliminary injunctions, which may be granted to immediately cease alleged infringing activities, including suspension of marketing or distribution.

The BPS also provides for compensation for damages, including under Article 44, which allows patent holders to claim damages for acts occurring from the publication of the patent application, provided the infringer had knowledge of its content. Damages may be calculated based on lost profits, infringer’s gains or reasonable royalties.

In pharmaceutical patent disputes, it is common for courts to order technical expert evidence, particularly to conduct a comparative analysis between the patented product and the allegedly infringing product. This expert analysis is often central to determining infringement, given the complexity of formulations, processes and equivalence issues.

As for defense strategies, defendants typically raise non-infringement arguments and, importantly, may challenge patent validity. A key mechanism is the incidental allegation of patent invalidity within infringement proceedings.

The Superior Court of Justice (STJ), in EREsp No. 1,332,417, confirmed that defendants may raise invalidity as a defense in infringement actions, even though a formal erga omnes declaration of nullity must be pursued in a separate action before federal courts. While state courts cannot formally annul patents, they may refuse enforcement inter partes if convincing invalidity arguments are presented.

In parallel, defendants often initiate nullity lawsuits before federal courts, sometimes requesting suspension of the infringement case.

Overall, patent enforcement in Brazil is characterized by:

• frequent use of preliminary injunctions;
• central role of technical expert evidence, especially in pharmaceutical cases;
• availability of damages, including pre-grant damages (Article 44, BPS); and
• strategic interplay between infringement claims and validity challenges, including incidental nullity arguments.

This creates a technically complex and highly strategic litigation environment, particularly in the life sciences sector.

17. Does your jurisdiction provide for restrictions on the use of trademarks for medicinal products, medical devices, food, and food supplements?

Brazil has no linkage system, thus trademark use in the life sciences sector is subject to IP protection rules under the BPS (registration before the BRPTO, requiring distinctiveness and non-deceptiveness) and sector-specific restrictions enforced by ANVISA during product approval, but in a separate and individualized manner.

In practice, trademarks must not be misleading, create confusion with other products, or imply unapproved therapeutic effects or superiority, and must align with the product’s regulatory classification and approved indications. Additional limitations apply to food and supplements, which cannot suggest medicinal properties. Advertising rules and consumer protection laws further reinforce these constraints. As a result, the BRPTO registration does not guarantee regulatory acceptance, and companies must align trademark strategy with regulatory requirements to avoid delays or rebranding.

18. Please briefly describe the product liability regime for medicinal products, medical devices, and food supplements in your country.

Brazil adopts a strict product liability regime largely grounded in the Consumer Protection Code (CDC – Law No. 8,078/1990), which applies across the life sciences sector, including medicinal products, medical devices, food and food supplements.

Under the CDC, manufacturers, importers and distributors are subject to objective (strict) liability for damages caused by defective products, irrespective of fault. A product is deemed defective where it fails to provide the safety that consumers are reasonably entitled to expect, taking into account its presentation, intended use and risks.

In the life sciences context, liability typically arises from:

• design defects (e.g., inherent safety issues in a medicine or device);
• manufacturing defects (e.g., contamination or deviations from GMP);
• information defects (e.g., inadequate labelling, insufficient warnings or misleading instructions for use).

“Information defects” are particularly relevant in regulated sectors such as pharmaceuticals and medical devices, given the importance of accurate labelling, package inserts and risk communication, all of which must align with ANVISA-approved documentation.

The CDC allows claims to be brought against all entities in the supply chain, although liability is generally more directly enforced against manufacturers and importers. Defenses are limited and include:

• proof that the product was not defective;
• absence of a causal link between the product and the alleged damage; or
• that the product was not placed on the market by the defendant.

Unlike some jurisdictions, regulatory compliance (e.g., ANVISA approval) does not fully shield companies from liability, although it may be considered as evidence of due diligence or influence the assessment of defectiveness.

Additionally, the regime is complemented by:

• Civil Code provisions (general tort liability);
• ANVISA enforcement powers, including recalls and market withdrawals; and
• potential collective actions (class actions) brought by public prosecutors or consumer protection entities, which are common in Brazil and can significantly increase exposure.

In the pharmaceutical sector, courts also frequently address issues such as:

• off-label use and its impact on liability allocation;
• failure to warn regarding known or foreseeable risks;
• disputes involving biosimilars/generics interchangeability; and
• supply failures, particularly in the context of public health litigation.

For medical devices and food supplements, similar principles apply, with additional scrutiny on product classification and claims, especially where supplements are marketed with quasi-therapeutic representations.

Overall, Brazil’s regime imposes broad and consumer-friendly liability standards, combining strict liability, limited defenses and strong procedural tools (including collective litigation), which creates a high exposure environment for life sciences companies, even where products have been duly approved by the regulator.

19. Please provide a short overview of risks of liability (criminal liability, serious administrative / civil liability) and enforcement practice with regards to medicinal products (including biologicals), medical devices, foods, and food supplements.

The life sciences sector in Brazil is subject to overlapping layers of administrative, civil and criminal liability, with active enforcement by regulatory authorities and increasing judicial scrutiny.

From an administrative perspective, ANVISA and local health authorities (within the SNVS) exercise broad sanitary police powers under Law No. 6,437/1977, allowing them to impose sanctions such as:

• warning notices and infraction penalties
• fines (which can be significant depending on the violation)
• product seizure and destruction
• suspension of manufacturing, distribution or marketing
• cancellation of product registration or company authorizations

Administrative enforcement is highly active, particularly in areas such as product safety, GMP/GDP compliance, advertising irregularities, labelling deficiencies and distribution failures. Preventive and corrective measures (e.g., recalls and field safety actions) are frequently required.

From a civil liability standpoint, companies are exposed under the strict liability regime of the Consumer Protection Code (CDC), as well as general tort rules. Risks include:

• individual claims for damages caused by defective products
• collective/class actions brought by public prosecutors or consumer protection entities
• liability arising from misleading advertising, off-label promotion or failure to warn

Civil exposure is particularly relevant in Brazil due to the strength of collective litigation mechanisms and the judiciary’s consumer-friendly approach.

From a criminal law perspective, certain violations may trigger liability under the Penal Code and sanitary legislation, especially where conduct involves:

• falsification or adulteration of medicines or health products
• distribution of unregistered or prohibited products
• conduct that creates a risk to public health

Although criminal enforcement is less frequent than administrative action, it can have serious reputational and operational consequences, particularly in high-profile cases.

In addition, Brazil is characterized by a significant degree of “judicialization of healthcare”, whereby courts are frequently called upon to adjudicate disputes involving:

• access to medicines and medical devices
• supply obligations of public authorities
• compliance with regulatory or reimbursement decisions

This dynamic can create indirect liability risks, especially where companies are involved in supply chains affected by court orders.

Enforcement practice in Brazil reflects a combination of proactive regulatory oversight and reactive judicial intervention, with increasing coordination between authorities and growing attention to:

• post-market surveillance and safety compliance
• advertising and promotional practices
• traceability and supply chain integrity

Overall, the Brazilian environment is high-risk from a compliance perspective, requiring companies to adopt robust regulatory, legal and internal controls to mitigate exposure across administrative, civil and criminal fronts.

20. Does your jurisdiction provide for a specific legislative and regulatory framework for digital health applications (e.g., medical apps)? If yes, please briefly describe the relevant framework.

Brazil does not have a single unified framework for digital health but applies a multi-layered approach. Digital applications may be regulated as medical devices (SaMD) by ANVISA, depending on their function, following a risk-based model.

Telemedicine is specifically regulated by Law No. 14,510/2022 and CFM Resolution No. 2,314/2022, which require that remote care follows the same ethical standards as in-person care, with physician responsibility, informed consent and use of secure digital tools (e.g., electronic prescriptions).

Additionally, digital health solutions must comply with data protection rules (LGPD) and general consumer and civil liability laws.

Overall, Brazil adopts a fragmented but flexible framework, allowing the use of digital tools (including remote care and digital platforms) while ensuring patient safety, data protection and regulatory oversight.

21. Does your jurisdiction provide for laws or certain legal measures to ensure the supply of medicinal products and medical devices, or are such rules envisaged in the future? If yes, please briefly describe those rules.

Yes. Brazil combines regulatory exceptions, public procurement mechanisms, judicial pathways and industrial policy tools to ensure access to medicines and medical devices.

As a general rule, products must obtain ANVISA marketing authorization before being supplied. However, regulated exceptions allow patient access to unauthorized products in limited cases where no satisfactory therapeutic alternative is available:

• For medicines, RDC No. 38/2013 provides mechanisms such as compassionate use, expanded access programs and post-trial supply, enabling access to investigational products for patients with serious or life-threatening conditions.
• For medical devices, RDC No. 608/2022 establishes a similar compassionate use pathway for high-risk or experimental technologies.

These mechanisms are exceptional and controlled, do not constitute full commercial authorization, and typically require ANVISA approval and ongoing safety monitoring.

In parallel, Brazil maintains a strong public access system through the Unified Health System (SUS), which supplies medicines and devices free of charge once incorporated. Complementing this, the Farmácia Popular program subsidizes or fully covers certain medicines dispensed through private pharmacies, improving affordability and access for the population.

A distinctive feature of the Brazilian system is the “judicialization of healthcare”, whereby patients seek court orders to obtain medicines or devices not available through standard channels. The Supreme Federal Court (STF), in RE 657.718 (Tema 500), established that:

• as a rule, the State cannot be compelled to provide unregistered or experimental medicines;
• exceptions may apply in cases of unreasonable regulatory delay, subject to strict cumulative criteria (e.g., pending ANVISA application, approval abroad, and lack of therapeutic alternatives); and
• court-ordered supply must respect CMED pricing rules.

Additional STF case law has refined these standards for import-authorized products and registered but non-incorporated medicines, reinforcing deference to ANVISA and CONITEC.

Finally, Brazil’s legal framework includes industrial policy tools to address supply constraints, notably the possibility of compulsory licensing under Article 68 of the Industrial Property Law (LPI). This mechanism may be invoked where the patent holder:

• fails to meet national demand, or
• engages in abuse of economic power (e.g., excessive pricing),

allowing third parties to produce or import the medicine to ensure public access.

Overall, Brazil adopts a multi-layered access model, combining regulatory flexibility, public funding, judicial intervention and patent law tools to address supply challenges, particularly for high-cost or innovative therapies.

22. Are there any specific compliance standards in your jurisdiction for the marketing of medicinal products and medical devices (e.g., codes of conducts of industry associations, etc.)? If yes, please give a brief overview of the relevant standards.

Yes. In Brazil, marketing practices are governed by ANVISA rules (e.g., RDC No. 96/2008) and the Consumer Protection Code, and are further reinforced by industry self-regulation.

Key compliance standards include:

• adherence to scientific accuracy and approved indications;
• restrictions on interactions with healthcare professionals (e.g., gifts, sponsorships);
• transparency in financial relationships; and
• clear separation between promotion and scientific/educational activities.

Relevant industry codes (e.g., INTERFARMA, ABIMED, ABIAD) often impose stricter standards than legislation, particularly in areas such as HCP engagement and digital promotion.

In addition, companies must comply with anti-corruption laws (Law No. 12,846/2013) and typically implement internal compliance programs (training, approvals, audits).

Overall, Brazil combines hard law and strong self-regulation, with increasing scrutiny of promotional practices.

23. Please state 3-5 key decisions by courts or regulatory authorities that have been issued recently and that are relevant for the life sciences sector.

Constitutional Challenge (ADI) No. 5529

The Brazilian Supreme Court’s decision in ADI 5529 concerned the constitutionality of the sole paragraph of Article 40 of the BPS, which guaranteed a minimum patent term of 10 years from grant (and 7 years for utility models), regardless of examination delays. This mechanism effectively extended patent terms beyond the statutory 20 years counted from the filing date, particularly in cases of administrative backlog at the BRPTO. The lawsuit argued that such automatic extensions violated core constitutional principles, including the temporary nature of patent protection, legal certainty, free competition, consumer protection, and the right to health, especially in the pharmaceutical sector.

In its ruling of May 2021, the Supreme Court declared the mechanism unconstitutional as it provided for an automatic and indiscriminate extension of patent terms. The Court clarified that compensation for administrative delay is not per se unconstitutional but must be granted on a case-by-case basis, grounded in clear and objective criteria rather than through a blanket rule tied solely to examination delays. The Court emphasized that any extension mechanism must enhance predictability and efficiency and should not incentivize administrative inefficiency.

The Court also modulated the effects of its decision. As a general rule, the declaration of unconstitutionality produced ex nunc effects, preserving the validity and terms of patents already granted under the previous regime. However, two key exceptions were introduced with ex tunc (retroactive) effects: (i) patents subject to pending invalidity lawsuits filed before 7 April 2021, and notably (ii) patents relating to pharmaceutical products, processes, and healthcare technologies, whose terms were immediately reduced to 20 years from filing. This differentiated treatment was justified by the public interest in safeguarding access to medicines and controlling public health expenditures, particularly in the context of the COVID-19 pandemic.

The decision has had profound implications for the pharmaceutical industry in Brazil. Thousands of patents – especially in the health sector – had their terms abruptly shortened, directly affecting exclusivity periods and anticipated returns on investment. For instance, the minimum post-grant term guarantee was eliminated, exposing patentees to the full impact of examination delays without compensatory mechanisms. The BRPTO implemented the decision through administrative acts that uniformly reduced patent terms, without conducting individualized assessments of delay. This resulted in immediate effects on thousands of pending and granted applications, significantly increasing legal uncertainty and prompting a surge in litigation seeking compensation for administrative delays, especially though the filing of patent term adjustments (PTA) lawsuits.

Final decision on the merits granting request for patent term adjustment –Vemlidy case

Among all the 93 PTA-lawsuits currently pending in Brazil, case No. 1028978-18.2022.4.01.3400 (Gilead vs. BRPTO) is particularly relevant as the Federal Court of Appeals for the 1^st Circuit has recognized the existence of unjustified administrative delay in the patent examination, granting the patentee’s request for the compensation of the patent term.

In that case, Gilead argued that the administrative proceeding for granting patent PI 0112646-6, related to drug Vemlidy® (tenofovir alafenamide hemifumarate), lasted over 16 years from filing, far exceeding statutory deadlines and violating fundamental procedural guarantees. Following the Brazilian Supreme Court’s decision in ADI 5529 and being a pharmaceutical patent, PI 646 fell within the exception carved out in the Supreme Court’s modulation of effects in ADI 5529, which imposed retroactive (ex tunc) consequences on patents in the healthcare sector, thereby eliminating previously granted term extensions and directly impacting Gilead’s exclusivity period. As a consequence, the patent term was abruptly reduced from a 10-year post-grant term to 20 years from filing, leading to its near-immediate expiration without any compensation for the delay.

Gilead’s claims for term adjustment was grounded primarily on state liability for administrative delay, relying on Article 37(6) of the Brazilian Constitution, as well as Article 27 of the LINDB and Article 9 of Decree No. 9.830/2019. The claimant argued that the BRPTO repeatedly failed to comply with legally mandated deadlines – particularly the 60-day period applicable to administrative acts – resulting in a quantifiable and unjustified delay.

In granting the claim, the Federal Court recognized the existence of unjustified administrative delay, emphasizing both the excessive duration of the examination process and the absence of any plausible justification by the BRPTO. The court held that, although the patentee only held an expectation of rights prior to grant, the patent was issued in 2017 under a legal framework that ensured a minimum post-grant term, creating legitimate expectations protected under principles of legal certainty and reasonableness. It further found that the abrupt curtailment of the patent term following ADI 5529, without any form of compensation, resulted in an undue imbalance that warranted judicial correction. Accordingly, the court ordered the restoration of the patent term until 18 January 2027, requiring the BRPTO to issue a new patent certificate reflecting the adjusted expiry date.

While the general rule in Brazil continues to reject automatic patent term extensions, this decision is highly relevant from a life sciences perspective as it suggest that, in exceptional cases involving extreme and unjustified administrative delay, courts may still order patent term adjustments based on principles such as legal certainty, legitimate expectations, and State liability. This scenario opens a potential avenue for pharmaceutical companies to seek compensation or term adjustments, especially in cases involving long examination backlogs.

Decision on new dosage regimen (caso Ocrevus® – ocrelizumab)

Another significant ruling from Brazilian courts has created an avenue for applicants to pursue the grant of patents involving new uses or dosage regimens. A prominent example is the decision in Appeal No. 1080806-87.2021.4.01.3400 (BRPTO v. Genentech), issued by the Federal Court of Appeals for the 1st Circuit (TRF-1). The case involved Brazilian Patent No. BR 12 2019 020930-8, which concerns the use of the drug Ocrevus® (ocrelizumab) under specific conditions—such as administering 0.6 g doses within a 14-day interval—for the treatment of multiple sclerosis.

Even though the application complied with the requirements established by the Brazilian Patent and Trademark Office (BRPTO), including the adoption of Swiss-type claims, the office rejected it on the grounds that the claimed subject matter constituted a therapeutic regimen. This refusal was later overturned at the trial level, and that decision was subsequently upheld by the 12th Panel of the TRF-1.

The court’s reasoning emphasized that the applicant had properly followed the structure of Swiss-type claims and that the BRPTO should not have based its rejection on Article 10(VIII) of the Brazilian Patent Statute (BPS). Notably, in its defense submissions at the trial stage, the BRPTO itself acknowledged that it had made an error in rejecting the application as if it related to a therapeutic method.

Since the BRPTO had not yet carried out a substantive patentability examination at the time of the rejection, the court ordered that the application be returned to the office for further review (an issue that remains under discussion). Nevertheless, the court made it clear that Article 10(VIII) of the BPS cannot be applied to this case. Therefore, while the BRPTO may still assess the application on technical grounds during the renewed examination, it cannot reject it on the basis that it represents a non-patentable therapeutic method under that provision.

Decision on divisional patent applications

The writ of mandamus No. 5103112-90.2021.4.02.5101 (ADAMA vs. BRPTO) case is part of a broader line of Brazilian litigation concerning the interpretation of the time limit for filing divisional patent applications under Article 26 of the BPS. In this case, ADAMA filed a divisional application after the rejection of its parent application, but the BPS archived it on the grounds that it had been submitted “after the end of examination” based on Article 32 of Instruction No. 30/2013.

ADAMA challenged this decision by arguing that the examination should only be considered concluded after a final, unappealable administrative decision, including the appeal stage. In its view, the BRPTO’s interpretation unlawfully restricted the right to divide applications and violated the BPS, the Paris Convention, and constitutional principles such as due process, legal certainty, and publicity.

The Federal Court, however, rejected these arguments and aligned with established case law, holding that the “end of examination” refers to the conclusion of the technical examination at first instance, rather than the exhaustion of administrative appeals. Accordingly, the court validated the BRPTO’s interpretation under Instruction No. 30/2013 as a legitimate clarification of the statutory regime.

A central element of the reasoning is that a divisional application constitutes a new and autonomous filing, not merely a continuation of the parent application. For this reason, the court held that divisionals cannot be introduced during the appeal stage, since appeals are limited to reviewing the original decision and do not allow procedural innovation such as the filing of new patent applications.

Overall, the ADAMA decision illustrates the prevailing jurisprudence in Brazil, which adopts a strict interpretation of Article 26 of the BPS. Courts consistently hold that divisional applications must be filed before the conclusion of first-instance examination, reinforcing legal certainty and procedural predictability, even if this limits applicants’ ability to file divisionals at later stages of the administrative process.

Discussions on article 32, BPS

Another trending topic in IP litigation in Life Sciences in Brazil is the discussion regarding the limits imposed by Article 32 of the BPS on amendments to the claim chart during prosecution. One relevant case on this matter is the invalidity lawsuit No. 5038252-85.2018.4.02.5101 (Blanver vs. Gilead and BRPTO), filed against the BRPTO’s decision which granted patent PI 0410846-9, covering the antiviral compound sofosbuvir (commercialized as Sovaldi®).

In essence, Blanver argued that the patent was granted in violation of both the temporal and purposive requirements established by Article 32, due to multiple amendments made to the claims long after the request for substantive examination. From a factual standpoint, the patent underwent five successive amendments to its claim set, with the first occurring nearly five years after the request for examination and others continuing throughout prosecution until shortly before grant.

These amendments significantly reduced the scope of protection—from an initial broad Markush formula covering a class of compounds to a final claim directed to a single, specific nucleoside. Blanver argued that such changes were not merely clarifying, but instead transformed the essence of the invention, violating Article 32 both in its temporal limitation (“until the request for examination”) and its functional limitation (“only to better clarify or define the invention”).

In its decision, however, the Federal Court upheld the validity of the patent and rejected the nullity claim, adopting a more flexible interpretation of Article 32. A central pillar of the reasoning was the acceptance of INPI Resolution No. 93/2013, which allows amendments—particularly restrictive ones—even after the request for examination, provided that they remain within the scope of the originally disclosed subject matter. The court considered this regulatory approach to be a legitimate and pragmatic adaptation of the statute, aimed at addressing the structural delays in patent examination in Brazil, which often extend for many years.

The judgment also emphasized that post-examination amendments may serve a corrective and adaptive function, enabling applicants to align their claims with technical objections raised during prosecution. In this sense, the court characterized such amendments—especially those that restrict the scope of protection—as compatible with the objectives of the patent system, even if submitted after the statutory deadline originally envisaged in Article 32. At the same time, the decision acknowledged the potential negative effects of this practice on legal certainty and competition, noting that competitors may be discouraged from innovating when faced with initially broad claims that are later narrowed. Nonetheless, it ultimately prioritized the need to preserve investments and avoid systematic rejection of applications due to procedural rigidities.

From a broader jurisprudential perspective, the case illustrates a tension within Brazilian case law regarding the interpretation of Article 32. While prior precedents—particularly from the Federal Court of Appeals for the 2nd Circuit (TRF-2)—have adopted a strict view that amendments after the request for examination are inadmissible, the present decision reflects a more permissive and policy-oriented approach. As such, the Gilead case highlights the ongoing lack of uniformity in Brazilian jurisprudence and signals that, despite the seemingly clear statutory deadline, courts may accept post-examination amendments where they are deemed to preserve the substantive validity of the patent and remain within the original disclosure.

24. What, if any, are the key legal and regulatory trends in your jurisdiction with regards to the digitalization of the local healthcare system and with regards to the use of artificial intelligence in the life sciences sector? Please briefly describe.

Brazil is experiencing a progressive digitalization of its healthcare system, supported by public policies (e.g., the National Digital Health Strategy) and increased adoption of telemedicine and digital platforms.

Key trends include:

• Expansion of telemedicine, under Law No. 14,510/2022 and CFM Resolution No. 2,314/2022, consolidating remote care as a regular modality subject to the same ethical standards as in-person practice;
• Growing regulation of software as a medical device (SaMD) by ANVISA, using a risk-based approach;
• Increasing relevance of the LGPD in governing health data use, particularly for AI-driven solutions;
• Gradual introduction of AI technologies in diagnostics and decision-support tools, with regulation still being addressed through existing frameworks;

Overall, Brazil follows a technology-neutral and adaptive regulatory approach, enabling innovation while maintaining focus on patient safety, data protection and regulatory oversight.

25. Please briefly highlight 3-5 key developments or trends in your jurisdiction with regards to the life sciences sector as you consider them relevant. This may include legislative proposals, market activity, etc.

ADI No. 5529: Pending bills and new BRPTO’s ordinances.

The Brazilian patent system has faced significant changes following the landmark Brazilian Supreme Federal Court (STF) decision on Constitutional Challenge (ADI) No. 5529. This very consequential decision on judicial review led to the revocation of the automatic adjustment of patent terms provided in Article 40 of the Brazilian Patent Statute (BPS).

Before ADI No. 5529, applicants in Brazil were assured a minimum ten-year patent protection term (or seven years for utility models), counted from the day on which the patent was granted. This mechanism acted as a safety net for applicants against the well-documented patent backlog and pendency issues of the Brazilian Patent and Trademark Office (BRPTO).

ADI No. 5529 removed this safety net. Although the decision had (mostly) prospective effects, patentees in the healthcare industry were hit especially hard. In its decision, the STF included a provision stipulating that it would have retroactive effect for patents covering pharmaceutical products, processes, equipment and materials “for use in healthcare”. That led to a significant shortening of patent terms for many patents in the healthcare industry (eg, pharmaceuticals).

The immediate response was a wave of litigation. Specifically, pharmaceutical companies started filing lawsuits requesting compensation in the form of term of protection equal to the period lost due to the BRPTO’s inactivity during prosecution. By the end of 2025, more than 70 lawsuits had been filed, seeking compensation for the term of protection reduced due to the BRPTO backlog. The results were a mixed bag. Many preliminary injunctions were granted and later revoked – some lasted over two years, and the initial trial court decisions on the merits denied the complaints. However, 2025 saw the first two favorable decisions being rendered in major cases. Although it is still too early to say that the tide has turned, these decisions provide an encouraging sign for prospective Patent Term Adjustment (PTA) plaintiffs.

Compensation for losses in the term of protection lawsuits relies on provisions from Statute No. 9,784/99 (Federal Administrative Proceedings Statute), which establishes deadlines for when administrative proceedings shall be decided. These deadlines are useful to ascertain when the administration has taken too long to decide on a given issue.

Currently, there are no specific provisions in the BPS or other patent statutes concerning the possibility of term adjustment such as in other jurisdictions. This lack of specific legislative provision is a gap in the law, and the courts are being called upon to fill it in the current lawsuits. However, that gap may be filled in the near future.

Since ADI No. 5529, discussions regarding the introduction of a specific compensation regime in Brazilian statute have gained weight and political backing. The following bills are currently being evaluated in Congress.

Bill No. 2,210/2022 proposes amendments to the BPS to reduce the BRPTO’s backlog. One of the main proposals of this bill is to simplify the filing of the patent application, allowing inventors to request a priority date with no need to immediately submit complete technical documentation. The Brazilian Senate recently presented Amendment No. 4, which allows PTA proceedings before the BRPTO whenever there is an unjustifiable delay attributable to the BRPTO’s examination. In any event, adjustments may not exceed five years, and shall be proportional to the delay in the actual case. Bill No. 2,210/2022 is still pending approval by the Federal Senate.

Bill No. 2,056/2022 also provides for the possibility of the patentee requesting PTA (limited to a five-year maximum adjustment) based on the BRPTO’s delay in examination. Under this bill, the request for PTA would also be subjected to a five-year statute of limitations based on the expiration of the patent term (ie, PTA may be sought within the five years following the patent’s expiry). This bill is still pending approval by the House of Representatives.

Bill No. 1,471/2023 proposes three rules for extending patent terms: (i) any extension is limited to a maximum period of five additional years of patent protection; (ii) eligible patents must have had ten years between filing and granting of the patent; and (iii) only one extension per product would be available. This bill is also pending approval by the House of Representatives.

Bill No. 5,810/2025 also proposes the possibility of PTA in proportion to the BRPTO’s delay but limited to a maximum five-year extension. According to this bill, the patentee would have 60 days after the patent’s grant to request term adjustment. The bill also provides a transitional rule extending the same 60-day window for patentees that have already filed PTA lawsuits to request term adjustment (counting from the day in which the bill passed into law). Bill No. 5,810/2025 is pending approval by the House of Representatives.

Complementary Bill No. 32/2026 introduces a further layer to the Brazilian PTA debate. This proposal expressly provides for the possibility of retroactive application of a PTA mechanism to patents in the pharmaceutical and healthcare equipment sectors. This feature distinguishes it from other pending bills, which are more cautious in addressing retroactivity or limit its scope to ongoing or future cases. From a policy perspective, this proposal aligns with ongoing judicial discussions in PTA litigation, especially those in the second wave, where applicants seek to restore lost patent term due to BRPTO delays prior to the STF ruling. It reinforces the argument that administrative inefficiencies should not result in a definitive loss of exclusivity, particularly in sectors where regulatory timelines are intrinsically long.

Overview of the PTA-like lawsuits

There are currently 93 PTA-related lawsuits pending in Brazil, reflecting a significant and growing wave of litigation following the STF’s decision in ADI 5529. These cases are divided into two main waves: 33 cases in the first wave and 60 in the second wave. Jurisdiction is heavily concentrated in the Federal Court of Appeals for the 1st Circuit (TRF-1), which accounts for 86 cases, followed by the Federal Court of Appeals for the 2^nd (4 cases) and 3^rd Circuits (3 cases).

The first wave of lawsuits is grounded primarily in the State’s strict civil liability. Plaintiffs argue that the BRPTO caused undue delays in examination, thereby generating damages that must be compensated. These claims rely on general provisions of the Federal Constitution, Civil Code, and administrative law, seeking financial or term-based compensation equivalent to the exact delay period.

In contrast, the second wave emerged after the STF invalidated the patent term extension mechanism in ADI 5529. These cases are more specifically structured as PTA-like claims, aiming not only to compensate for administrative delay but also to restore or extend the patent term of already granted patents affected by the decision. The legal rationale is based on an alleged regulatory gap in Brazilian law, prompting courts to apply, by analogy, PTA mechanisms adopted in other jurisdictions.

Regarding procedural status, the dataset shows a mixed and still evolving litigation landscape. Out of the 93 cases, there are 2 favorable decisions on the merits and 38 unfavorable ones, with 42 appeals pending. As for interim relief, 29 requests for preliminary injunctions (PIs) have been filed, with 8 granted overall, but only 2 currently in force. Numerous interlocutory appeals (25) have also been brought in connection with these injunctions, demonstrating that urgent relief remains highly contested and relatively limited in effectiveness. Overall, while PTA litigation is widespread, courts have so far shown a cautious approach, particularly in granting provisional measures.

Upcoming rules concerning patents for dosage regimens and new medical uses

The patentability of dosage regimens remains a central issue in Brazil’s life sciences and pharmaceutical sectors. These types of inventions are valuable because they define how known drugs are administered—such as dosage, frequency, and duration—often improving patient adherence. However, the Brazilian Patent and Trademark Office (BRPTO) frequently considers such claims to be excluded from patentability under Article 10(VIII) of the Brazilian Patent Statute, which prohibits protection for therapeutic methods.

This restrictive interpretation has sparked ongoing debate, particularly when compared to other jurisdictions. In the United States, dosage regimens are generally patentable if standard requirements are met, while the European Patent Office allows them even when the dosage itself is the only novel aspect. Brazil’s approach is closer to China’s, where novelty is not recognized if it arises solely from how a substance is administered, requiring applicants to rely on Swiss-type claims that link the use to the manufacture of a medicament.

To clarify its position, the BRPTO has issued guidelines such as Resolutions No. 169/2016 and 208/2017, which establish rules for drafting and examining claims involving new uses. Further updates are under discussion through Public Consultation Notice No. 2/2025, which includes proposals to refine examination standards. These proposals reinforce that novelty must be based on a new therapeutic indication and require strong experimental evidence—preferably in vivo—to support use claims. They also maintain that dosage regimens alone cannot establish novelty.

Despite this administrative stance, court decisions have created important precedents for applicants. In the Genentech case (TRF-1), the judiciary overturned the BRPTO’s rejection of a patent involving a specific dosing schedule for treating multiple sclerosis. The court held that Swiss-type claims were properly used and that Article 10(VIII) had been incorrectly applied, sending the application back for technical examination while preventing rejection on therapeutic method grounds.

A similar outcome was seen in the Wyeth case (TRF-2), where the court rejected the BRPTO’s argument that a divisional application improperly changed claim scope. The judiciary reaffirmed that Swiss-type claims are valid and do not fall under the statutory exclusion, also confirming compliance with amendment rules. Overall, these rulings highlight the judiciary’s role in correcting overly strict interpretations by the BRPTO and ensuring a more balanced approach to patent protection in Brazil.

Bills regarding compulsory licenses of medical products (Lenacapavir and Mounjaro)

The debate over compulsory licensing in Brazil has intensified in 2026, with multiple legislative initiatives targeting high-cost innovative medicines. In addition to Bills No. 68/2026 and No. 160/2026 concerning tirzepatide (Mounjaro), Bill No. 418/2026 introduces a parallel discussion in the HIV field, focusing on Lenacapavir, a long-acting antiretroviral developed by Gilead. Collectively, these proposals signal a broader legislative trend aimed at expanding access to breakthrough therapies through the use of patent flexibilities grounded in public interest considerations.

Bills No. 68/2026 and No. 160/2026 are primarily motivated by concerns over pricing and access to Mounjaro. While Bill No. 68/2026 seeks to classify tirzepatide-based medicines as being of public interest—thereby facilitating the adoption of compulsory licensing – Bill No. 160/2026 goes further by outlining a framework for the possible grant of temporary, non-exclusive licenses. The latter ties the issuance of such measures to a prior technical assessment by ANVISA, focusing on factors such as excessive pricing, insufficient supply, and the broader public health impact associated with obesity and diabetes.

In a similar vein, Bill No. 418/2026 proposes to declare Lenacapavir as a product of public interest for the purposes of Article 71 of the BPS, thus paving the way for a potential compulsory license. The bill is grounded in the argument that Lenacapavir represents a highly effective innovation for HIV prevention and treatment, notably due to its long-acting formulation requiring only biannual administration. However, its high cost and the existence of patent protection are cited as key barriers to incorporation into the Brazilian Unified Health System (SUS), limiting access for vulnerable populations and undermining national HIV control strategies.

The main legal justifications underlying these initiatives are broadly aligned: (i) the existence of a public health need (obesity, diabetes, and HIV); (ii) the inability of the public system to ensure widespread access due to high prices; (iii) supply constraints or market exclusivity derived from patent rights; and (iv) the social function of intellectual property. In the case of Lenacapavir, additional arguments include Brazil’s exclusion from voluntary licensing agreements and the risk that patent monopolies will delay access to generic alternatives, further reinforcing inequities in access to essential medicines.

From a legal standpoint, compulsory licensing in Brazil is governed by Articles 68 to 74 of the LPI. These provisions establish that patent rights may be limited in cases of abuse of economic power, failure to exploit the patent locally, or insufficient supply (Article 68), as well as in situations of national emergency or public interest (Article 71). While the recent bills do not themselves grant compulsory licenses, they aim to facilitate or justify their adoption by framing specific medicines as matters of public interest, thereby reinforcing the legal pathways already under Brazilian law.

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  Eduardo Hallak

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  Juliana Neves

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  Juliana Libman

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  Lívia Maldi