Life Sciences & Healthcare Newsletter – April 2026

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May 08, 2026

11 min read

Introduction
ON FOCUS
Regulatory
Intellectual Property
Litigation
PRESS

ON FOCUS

Regulatory

Retail sale of medicines

New law authorizes the sale of medicines in supermarkets

On March 23, 2026, Law No. 15,357/2026 was enacted, regulating the installation and operation of pharmacies and drugstores within supermarkets, provided that they operate in a dedicated, clearly demarcated sales area compatible with the exercise of pharmaceutical activities. The law consolidates a set of sanitary, operational, and safety requirements that must be observed to enable the sale of medicines in such establishments.

In practice, the new law seeks to expand public access to medicines, especially in locations with a limited number of pharmacies, without relaxing the strict compliance with technical requirements and precautions inherent to the safe dispensing of products subject to health surveillance.

Medicines and technologies in the Public Healthcare System (SUS)

Federal Court of Accounts identifies weaknesses and Ministry of Health Creates Price Governance Committee

The Federal Court of Accounts (TCU) determined that the Ministry of Health must, within 90 days (i.e., by June 29, 2026), adopt measures to address weaknesses in the process of incorporating medicines, tests, and other technologies into the Brazilian Unified Health System (SUS). The decision was based on analyses conducted between 2021 and 2023 within CONITEC, which identified gaps in the verification of technical qualifications of members, deficiencies in economic studies, and a lack of alignment between incorporation decisions and budget forecasts.

In response, the Ministry of Health announced its intention to create a Price Negotiation Committee to support the incorporation of medicines, vaccines, and other technologies into SUS, inspired by international models. The measure aims to strengthen governance, institutionalize price negotiations, and address the TCU’s findings. The draft ordinance establishing the committee has not yet been published.

Drug pricing

CMED establishes annual price adjustment at the lowest level in nearly 20 years

On March 31, 2026, CM-CMED Ordinance No. 04/2026 was published, establishing the maximum price adjustment for medicines across the national territory, pursuant to Article 4 of Law No. 10,742/2003. The regulation authorizes companies to implement price increases as of the same date, using as reference the Factory Price (PF) set out in the official list published by the Medicines Market Regulation Chamber (CMED) on the Brazilian Health Regulatory Agency (ANVISA) website.

The 2026 annual adjustment was set at levels considered the lowest in nearly two decades, varying according to the level of competition of the product: up to 3.81% for Level 1 (high competition), 2.47% for Level 2 (intermediate competition), and 1.13% for Level 3 (low competition).

In practice, the application of these percentages remains conditional upon the regular submission of the Commercialization Report to CMED, in accordance with Notice No. 11/2015, as well as compliance with the Maximum Consumer Price (PMC) limits, taking into account ICMS variations across Brazilian states and the applicable price transparency and disclosure rules.

Also on March 31, 2026, CM-CMED Ordinance No. 05/2026 was published, setting forth the methodology for determining the Factory Price (PF) and the Maximum Consumer Price (PMC) of medicines, with the purpose of aligning the official price lists with the amendments to the positive list introduced by Complementary Law No. 224/2025.

In an official statement, CMED informed that, following the conclusion of the price adjustment process, it will publish a new price list reflecting the updated values in light of the new tax framework. CMED also clarified that the annual price adjustment should be carried out using the conversion factors in effect prior to the publication of the relevant resolution.

Patient rights

Law establishes rules for healthcare services

On April 7, 2026, Law No. 15,378/2026 was enacted, establishing the Patient Rights Statute and creating a nationwide legal framework applicable to healthcare services provided by professionals and institutions, both in the public and private sectors.

The statute consolidates and systematizes patients’ rights and duties, with emphasis on decision-making autonomy, informed consent, access to medical records, the right to clear information, second medical opinions, the presence of a companion, confidentiality of health data, and palliative care, while also setting forth user responsibilities. As such, the statute serves as a regulatory benchmark for the delivery of healthcare, guiding clinical, administrative, and organizational practices.

In practice, the new law raises regulatory and risk management standards, requiring market participants to review and adapt clinical protocols, consent frameworks, data governance practices, and communication strategies with patients.

Healthcare discount cards, prepaid services, and related products

ANS initiates regulatory process

On April 17, 2026, the National Supplementary Health Agency (ANS), during the 6th Extraordinary Meeting of its Board of Directors, approved the launch of a public call and the establishment of an internal committee to initiate the regulatory process for healthcare discount cards, prepaid services, and related products, in response to the expansion of this market and the absence of a specific regulatory framework. ANS’s authority to act in this matter is supported by a recent decision of the Superior Court of Justice (STJ), issued in Special Appeal No. 2,183,704/SP, which recognized the Agency’s competence to regulate and oversee such activities.

The public call, already approved but not yet open for submissions, constitutes a consultative and preparatory stage of the regulatory process. Its purpose is to gather information from companies operating in the segment, enabling ANS to map business models, contracting structures, provider networks, service delivery modalities, adjustment criteria, and commercial practices, as a basis for the development of a specific regulatory framework. The initiative stems from the recognition that, although these products are not classified as private health insurance plans, they produce relevant effects on the regulated market and on consumer protection.

In practice, the launch of the regulatory process is expected to increase transparency, governance, and compliance requirements, with direct effects on commercial strategies, consumer communication, contractual structuring, and pricing models. The measure may also influence investment decisions, consolidation dynamics, and the design of new business models in the supplementary health sector, by reducing areas of legal uncertainty and bringing the segment closer to more stringent standards of regulatory oversight.

Public consultations

ANS Public Consultation No. 170: Proposal for a new normative resolution on contracting between private health plan operators and healthcare service providers.
Deadline: April 1, 2026 to May 16, 2026.

ANVISA Public Consultation No. 1,392: Proposal for a new normative resolution on the coordination, structuring, organization, and implementation of health surveillance activities carried out by the Federal Government, states, Federal District, and municipalities.
Deadline: April 6, 2026 to July 4, 2026.

Ministry of Health Public Consultation No. 1/2026: Proposal for a resolution on guidelines for biobanks and the use of human biological material in research within the framework of the National System of Ethics in Human Research (SINEP).
Deadline: April 2, 2026 to June 2, 2026.

We continue to monitor

Supplementary Health: ANS releases 2025 economic and financial data;

Sale of Medicines via Marketplaces: ANVISA to discuss the commercialization of medicines through third-party online platforms;

Agribusiness: Learn more about André de Paula, the new Minister of Agriculture and Livestock;

House of Representatives Health Committee: Giovani Cherini appointed as the new Chair of the Health Committee;

Technical Cooperation: CNJ, the Ministry of Health, and the Federal Attorney General’s Office (AGU) enter into an agreement to expand consensual dispute resolution mechanisms in healthcare matters.

Intellectual Property

Digital transformation of SUS

Restructuring of the Data Protection Authority strengthens the regulatory environment

On February 25, 2026, Law No. 15,352/2026 was enacted, converting Provisional Measure No. 1,317/2025 into law and formally establishing the Brazilian Data Protection Authority (ANPD) as an independent regulatory agency. The measure grants ANPD greater functional, technical, decision-making, administrative, and financial autonomy. In addition, the new law strengthens the Agency’s regulatory and enforcement capacity, including through the creation of a specialized career track and 213 new permanent positions. It is worth noting that the protection of sensitive personal data, as defined under the Brazilian General Data Protection Law (LGPD)—particularly health-related data—is among the priority topics in ANPD’s regulatory agenda and enforcement priorities.

In the healthcare sector, the institutional consolidation of ANPD is expected to contribute to a more stable regulatory environment, which may foster digital transformation initiatives within the Brazilian Unified Health System (SUS), such as system interoperability, telehealth, and data-driven solutions. At the same time, the strengthening of ANPD’s institutional capacity enables more effective enforcement and signals a potential increase in compliance and governance expectations for both public and private actors, particularly with respect to the processing of sensitive personal data.

Litigation

Insulin Pumps

Superior Court of Justice establishes technical criteria beyond ANS coverage list

In a landmark case decided under the repetitive appeals system, the Superior Court of Justice (STJ) established the conditions under which health plan operators may be required to cover insulin infusion pumps. The Court reaffirmed that the ANS coverage list does not constitute an absolute limit, while setting forth a structured evidentiary standard for granting coverage. According to the ruling, patients must demonstrate the medical necessity of the device, the lack of effective therapeutic alternatives included in the regulatory coverage list, and a prior denial by the health plan operator.

While the decision prevents automatic denials based solely on the absence of the procedure from the ANS list, it preserves safeguards against indiscriminate litigation involving high-cost technologies. As a result, the ruling consolidates a controlled expansion of coverage, requiring health plan operators to apply greater technical rigor in the assessment of individual cases and to adjust their medical review and auditing protocols.

Small group Health Plans

Termination now requires justification

The Superior Court of Justice (STJ) has also advanced its interpretation of collective health plans by ruling that agreements covering fewer than 30 beneficiaries cannot be unilaterally terminated without the presentation of a legitimate reason. The Court’s reasoning brings such contracts closer to the legal framework applicable to individual plans, with a strong emphasis on consumer protection principles, contractual good faith, and the recognized vulnerability of small groups.

This guidance is likely to reduce operators’ flexibility in managing their portfolios, directly impacting how risks are priced and allocated. The ruling may have significant implications for the structuring of products aimed at small and medium-sized enterprises, requiring contractual revisions, pricing adjustments, and more cautious underwriting and contract maintenance strategies.

Medical auditing under scrutiny

Judicial limits on CFM regulation

A recent preliminary injunction partially suspended provisions of Resolution No. 2,448/2025 issued by the Federal Medical Council (CFM), which regulates medical auditing. The court’s rationale was based on concerns that the regulation may have exceeded the scope of professional oversight by interfering with operational aspects typically assigned to health plan operators and the National Supplementary Health Agency (ANS).

This development highlights an ongoing institutional tension between regulatory authorities and professional bodies, creating short-term uncertainty regarding the rules applicable to medical auditing. At the same time, it reinforces the role of the Judiciary as an arbiter of the scope and legitimacy of regulatory initiatives, with potential impacts on governance and the care management models adopted by health plan operators.

STJ deems limits on multidisciplinary therapy sessions for ASD abusive

In ruling on Theme No. 1,295, the Superior Court of Justice (STJ) held that limitations on the number of multidisciplinary therapy sessions prescribed for patients with autism spectrum disorder (ASD) are abusive. The decision encompasses therapies such as psychology, speech therapy, physiotherapy, and occupational therapy, establishing that (i) contractual or regulatory limits based solely on financial criteria are unlawful; and (ii) coverage must follow the medical prescription and the specific needs of the patient. The Court further clarified that such restrictions violate the legal framework governing health plans.

This ruling significantly strengthens beneficiary protection and is likely to increase operators’ cost exposure, particularly in long-term and high-frequency treatments. In practice, it calls for a review of coverage models, more robust technical provisions, and a redesign of claims management strategies for continuous, high-complexity therapies.

PRESS

_ Rubens Granja commented on the rise of healthcare litigation in Brazil, highlighting the growing volume of lawsuits and its impact on the healthcare system.

Read the publication on Viva Bem-Estar. (Available in Portuguese)

_ Rubens Granja authored an article on the new AI regulation, discussing its implications for the healthcare and life sciences sector.

Read the full article on Futuro da Saúde. (Available in Portuguese)

_ Rubens Granja commented on the Superior Court of Justice’s decision requiring health plans to cover insulin pumps under specific conditions.

Read the article in Valor Econômico. (Available in Portuguese)

_ Experts discussed the impact of weight-loss injectable drugs on the food industry, highlighting shifts in consumer behavior and market dynamics.

Read Rubens’ featured post on LinkedIn News. (Available in Portuguese)

_ Industry experts analyzed the new regulation allowing supermarkets to sell medicines, outlining the expected changes in the retail landscape.