{"id":32028,"date":"2026-05-08T14:55:09","date_gmt":"2026-05-08T17:55:09","guid":{"rendered":"https:\/\/lefosse.com\/?p=32028"},"modified":"2026-05-12T16:32:23","modified_gmt":"2026-05-12T19:32:23","slug":"life-sciences-healthcare-newsletter-april-2026","status":"publish","type":"post","link":"https:\/\/lefosse.com\/en\/newsletter\/life-sciences-healthcare-newsletter-april-2026\/","title":{"rendered":"Life Sciences & Healthcare Newsletter \u2013 April 2026"},"content":{"rendered":"\n

ON FOCUS<\/mark><\/strong><\/h2>\n\n\n\n

Regulatory<\/mark><\/strong><\/h2>\n\n\n\n

Retail sale of medicines<\/mark><\/strong><\/h3>\n\n\n\n

New law authorizes the sale of medicines in supermarkets<\/strong><\/h3>\n\n\n\n

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.<\/p>\n\n\n\n

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.<\/p>\n\n\n\n

Medicines and technologies in the Public Healthcare System (SUS)<\/mark><\/strong><\/h3>\n\n\n\n

Federal Court of Accounts identifies weaknesses and Ministry of Health Creates Price Governance Committee<\/strong><\/h3>\n\n\n\n

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.<\/p>\n\n\n\n

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\u2019s findings. The draft ordinance establishing the committee has not yet been published.<\/p>\n\n\n\n

Drug pricing<\/mark><\/strong><\/h3>\n\n\n\n

CMED establishes annual price adjustment at the lowest level in\u00a0nearly 20\u00a0years\u00a0<\/strong><\/h3>\n\n\n\n

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.<\/p>\n\n\n\n

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).<\/p>\n\n\n\n

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.<\/p>\n\n\n\n

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.<\/p>\n\n\n\n

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.<\/p>\n\n\n\n

Patient rights<\/mark><\/strong><\/h3>\n\n\n\n

Law establishes rules for healthcare services<\/strong><\/h3>\n\n\n\n

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.<\/p>\n\n\n\n

The statute consolidates and systematizes patients\u2019 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.<\/p>\n\n\n\n

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.<\/p>\n\n\n\n

Healthcare discount cards, prepaid services, and related products<\/mark><\/strong><\/h3>\n\n\n\n

ANS initiates regulatory process<\/strong><\/h3>\n\n\n\n

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\u2019s 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\u2019s competence to regulate and oversee such activities.<\/p>\n\n\n\n

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.<\/p>\n\n\n\n

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.<\/p>\n\n\n\n

Public consultations <\/strong><\/h3>\n\n\n\n