BRAZIL Trends and Developments Contributed by: Bruna Rocha, Jessica Filka, Juliana Marcondes and Victoria Cristofaro, COSRO
Capital catalysis and public funding windows Public funding and industrial policy tools have tak- en on a catalytic role. Beyond direct funding, they structure demand, reduce execution risk and cre- ate bankability conditions for private investment. On the industrial policy side, the Ministry of Health has advanced the PDP pipeline by authorising the exe- cution of commitment terms for projects selected in the 2024 cycle. Publication of excerpts in the Official Gazette triggers the next implementation phase, rein- forcing SUS‑linked procurement as a demand anchor capable of unlocking investment decisions and local capacity build‑out. In parallel, Brazil has refined the operational frame- work for mobilising private capital into priority SUS projects through tax‑advantaged debentures. Minis- try of Health rules establish eligibility, monitoring and oversight criteria for qualifying health infrastructure investments as “priority projects” for the purposes of issuing incentivised debentures under federal stat- utes and implementing decrees. These instruments embed governance, transparency and accountability requirements into access to funding. For market par- ticipants, the practical implication is clear: bankability and adoptability constraints now shape design from the outset. Artificial intelligence and the internet of medical things Brazil’s regulatory and legislative landscape is also converging around a more unified framework for AI and connected health, signalling a decisive shift from pilot programmes to production-scale deployment. The pending AI Bill (No 2,338/2023), which the Senate approved in December 2024 – and which is now under review in the Chamber of Deputies – would establish a comprehensive, risk-based governance structure for AI applications, including those in healthcare, mod- elled in part on the EU AI Act. Under the proposal, the National Data Protection Authority ( Autoridade Nacional de Proteção de Dados ANPD) would co-ordi- nate a new national system for AI regulation and gov- ernance, working alongside sector-specific agencies such as ANVISA, which already oversees software as a medical device and AI-enabled diagnostics under its own evolving standards. Complementing this legisla- tive momentum, broader health data modernisation
nal governance and proactive portfolio mapping to preserve optionality. In parallel, active discussion of pricing criteria for medicines supplied pursuant to court orders under- scores the growing regulatory focus on judicialisation as a de facto access pathway. Judicialisation remains a defining feature of the Brazilian market, with direct implications for maximum government sales price parameters, public procurement benchmarks and allocation of supplier risk. Companies operating in litigation‑intensive therapeutic areas should integrate legal risk assessment into pricing, contracting and supply strategies rather than treating it as a down- stream exception. Clinical research and legal certainty In clinical research, Law No 14,874/2024 and its implementing decree consolidate the legal framework and increase certainty while leaving open important operational questions. Post‑study supply obligations, ethics committee governance and risk classification continue to shape sponsor decisions about trial budg- eting, site selection and long‑term exposure. A more predictable legal foundation is welcome, but compa- nies should expect continued evolution in operational detail and should plan governance and contracting around the remaining uncertainties. Industrial policy instruments and delivery discipline Industrial policy instruments remain central in 2026. Productive Development Partnerships ( Parcerias para o Desenvolvimento Produtivo – PDPs), under the umbrella of the Healthcare Economic‑Industrial Complex ( Complexo Econômico-Industrial da Saúde – CEIS) strategy, continue to link innovation, local production and SUS procurement. Participation now demands not only technological readiness but also robust governance, delivery capacity and compli- ance infrastructure. For private‑sector participants, PDPs offer scale and demand visibility but also impose heightened expectations for execution and accountability. Companies should treat governance, audit‑ready reporting and credible delivery capacity as prerequisites to access these instruments rather than as afterthoughts.
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