BRAZIL Trends and Developments Contributed by: Bruna Rocha, Jessica Filka, Juliana Marcondes and Victoria Cristofaro, COSRO
ordination in Brazilian portfolios. In medical devices and adjacent supply chains, maturing Asia‑facing strategies tighten competitive dynamics. In this con- text, regulatory capability is a differentiator not only for market entry but also for managing inbound competi- tion and heightened scrutiny. The patent cliff as an inflection point A concentrated wave of patent expirations spanning diabetes, obesity, oncology and immunology in 2026 is set to reshape competition. For generics and bio- similars, substitution is a race defined by execution, not regulatory approval alone. Winners synchronise regulatory timing, manufacturing scale‑up, distribution capacity and payer or distributor contracting well in advance of loss of exclusivity. In Brazil, where price erosion and volume reallocation can occur quickly, disciplined alignment across these dimensions can be decisive. For originators, the window to defend value is narrowing. Margin pressure and accelerated com- petition underscore the need to advance innovation pipelines, recalibrate pricing and access strategies, and deploy more sophisticated value defence meas- ures, including real‑world evidence generation, tar- geted post‑launch studies and differentiated access planning designed to sustain relevance beyond exclu- sivity. Practically speaking, loss‑of‑exclusivity plan- ning in Brazil now demands earlier, cross‑functional engagement, not reactive post‑approval adjustments. Regulatory agendas as market infrastructure Regulatory agendas function in 2026 as market infra- structure. ANVISA’s 2026–27 regulatory agenda, comprising a large set of priority topics and already operational, builds on reliance initiatives and pro- cess‑efficiency measures introduced in 2025. These include greater use of regulatory reliance, grouping of applications sharing technical or clinical reports, and targeted actions to reduce review timelines. At the same time, ANVISA is selectively recalibrating substantive frameworks across medicines, medical devices, food, cosmetics and adjacent sectors, with direct commercial and compliance implications. Key themes include continued development of regulatory sandboxes for innovative health technologies and emerging business models to reduce early‑stage legal uncertainty while accelerating access. Long‑standing frameworks are under review, including those applica-
ble to medical devices, software as a medical device (SaMD), transfer of product ownership and third‑party import operations. These revisions affect compliance design, portfolio management, M&A execution and complex group structures. The agenda also continues the gradual extension of post‑market logic and risk‑based oversight into hybrid sectors such as foods for special medical purposes, plant‑based products, nutrivigilance and materials in contact with food. Topics that are both politically and technically sensitive, among them medicinal canna- bis, aesthetic products with dermal action, accessibil- ity requirements for labelling and consumer informa- tion, and codified criteria for administrative settlement agreements, signal a broad emphasis on governance, transparency and legal certainty in enforcement. In parallel, the ANS has launched a public call for con- tributions to inform its 2026–28 regulatory agenda. The process is structured around macro‑themes that include supervision and enforcement, transparency, economic regulation, access guarantees, beneficiary relations, integration with SUS, information govern- ance and emerging challenges such as judicialisation, discount cards and rare diseases. For companies operating across public and private segments, these parallel agendas elevate the need for co-ordinated regulatory, pricing and access strategies. Pricing, access and judicialisation Pricing and access frameworks will remain commer- cially sensitive in 2026. CMED Resolution No 3/2025, effective 29 April 2026, replaces the long‑stand- ing drug pricing regime with a more granular, pro- cess‑driven model. The new framework introduces differentiated pricing categories, an expanded inter- national reference basket, stronger treatment of incre- mental innovation, and a tighter coupling between sanitary authorisation and pricing through mandatory and time‑bound submission of the Price Information Dossier ( Dossiê de Informações de Preço – DIP). Tran- sitional rules that address pending, omitted or pro- visional cases, combined with reinforced regulatory powers, increase both predictability and enforcement risk. Pricing strategy in Brazil now requires earlier alignment with regulatory timelines, disciplined inter-
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