Updates on the 17 Trends for the Healthcare Market in 2025
How are the 2025 predictions materializing?
At the beginning of the year, our Life Sciences & Healthcare team presented a comprehensive overview of the main trends that would shape the sector regulated by Anvisa and ANS in 2025, which you can find here. Now, several months later, it is time to examine the present and assess how these predictions are materializing in practice.
The healthcare market is dynamic by nature, and monitoring its real-time evolution is essential for companies, professionals, and managers to make well-founded strategic decisions. Therefore, we have prepared this update with the main developments observed in some of the trends we previously highlighted.
This is not merely an update of what was predicted, but a current portrait of how public policies, regulations, and innovations are effectively impacting the sector. Our objective is to provide practical and updated insights so that you can continue navigating safely in this constantly transforming landscape.
National Development Strategy for the Economic-Industrial Health Complex (“CEIS”): PDPs and PDILs
Initial Scenario (2025): We highlighted the resumption of Productive Development Partnerships (PDPs) and the implementation of the Local Development and Innovation Program (PDIL) as strategic movements to strengthen national production of medicines and health technologies. At that time, 322 proposals awaited analysis by the Ministry of Health. See the complete content here.
Recent Developments: The first semester of 2025 marked a significant acceleration in the implementation of these programs:
- Governance Structure: Publication of internal regulations for the Deliberative Committee and Technical Evaluation Commission, plus an informative note detailing analysis criteria.
- First Approvals: 33 projects approved by May (11 PDPs and 22 PDILs), focusing on strategic technologies for SUS, including vaccines, medicines, supplies, and innovative solutions in diagnostics, artificial intelligence, and medical devices.
- Leadership Changes: Alexandre Padilha assumed the Ministry of Health in March, with Fernanda De Negri appointed to SECTICS.
- Second Round: Additional approval of 29 projects in May (7 PDPs and 22 PDILs), including technological platforms and genetic tests.
Practical Impacts: With 37% of proposals already analyzed and an accelerated approval pace, the sector can expect greater regulatory clarity and concrete public-private partnership opportunities.
“Judicialização” of Health
Initial Scenario (2025): We indicated that STF decisions on Themes 6 and 1234 (Binding Precedents 61 and 60) would significantly transform the healthcare judicialization landscape. We highlighted the expectation of stricter criteria for granting medicines through judicial means, with greater requirements for high-quality scientific evidence, and the definition of responsibilities among federal entities. See the complete content here.
Recent Developments: The first months of 2025 revealed a scenario of transition and adaptation to new rules:
- Pending Issues: Declaratory Motions still proceed regarding Theme 6, maintaining some points under discussion at STF.
- National Platform: Creation of the platform that will centralize judicial demands for SUS medicines remains under development, without a defined launch timeline.
- Practical Impact: Greater rigor observed in courts’ analysis of requests, with increasing demand for specialized technical opinions and robust scientific evidence.
- Market Perception: Confirmation that “the bar has been raised” for claimants, generating debates about possible disproportionate consequences in treatment access.
- Judicial Governance: Beginning of greater organization and standardization in health demand analysis processes.
Practical Impacts: The adaptation period to new rules is generating both opportunities and challenges. While the judicial system gains greater organization and more solid technical criteria, patients and lawyers need to prepare for more complex and time-consuming processes.
Anvisa’s Administrative Sanctioning Procedures
Initial Scenario (2025): We identified as a relevant trend the regulation of Anvisa’s Administrative Sanctioning Procedures (PAS) through Public Consultation 1297/2024. We highlighted the main proposed changes: prohibition of suspensive effect in appeals against precautionary measures, TCAC regulation, greater clarity in penalty dosimetry, and implementation of risk-based responsive inspection. See the complete content here.
Recent Developments: After the public consultation ended in February 2025, the regulatory process advanced with important developments:
- Contribution Analysis: Anvisa received and is processing manifestations from the regulated sector regarding the initial proposal.
- Pillar Maintenance: The fundamental guidelines of the proposal remain unchanged, including the prohibition of suspensive effect and TCAC regulation.
- Dosimetry Improvements: The table of minimum and maximum values by company size, infraction nature, and risk is maintained, though practical characterization of these criteria still presents discretionary aspects.
- Responsive Inspection: Confirmed implementation of the approach based on proportional selection of administrative measures considering health risk, company history, and prevention needs.
- Publication Expectation: The sector awaits the final version of the resolution, which should incorporate adjustments based on best practices from other regulatory agencies.
Practical Impacts: PAS regulation represents a milestone in the search for greater predictability and proportionality in Anvisa sanctions. Although discretionary aspects that may generate uncertainties still exist, the new structure offers the regulated sector clearer tools for compliance and defense in sanctioning processes.
New Composition of the Boards of Directors: Anvisa and ANS
Initial Scenario (2025): We highlighted Anvisa’s critical situation, operating with only 2 effective members in a 5-position board, with interim members for almost 1.5 years. We identified presidential nominations of Leandro Safatle (President-Director), Daniela Marreco, and Diogo Soares for Anvisa, plus Wadih Nemer Damous Filho for ANS presidency, all awaiting Senate confirmation. See the complete content here.
Recent Developments: The board renewal scenario remains in a waiting pattern, with some important adjustments:
- Nomination Status: The three Anvisa nominations and the ANS nomination remain awaiting Senate confirmation scheduling.
- Internal Movement: Confirmed information that Meiruze Freitas, former Anvisa director, will assume the position of Director of the Department of Science, Technology and Innovation of the Economic-Industrial Health Complex at the Ministry of Health.
- Agenda Expectation: There is expectation that the Senate president will schedule regulatory agency confirmations, but still without a defined timeline.
- Operational Continuity: Anvisa continues functioning with reduced composition, which may impact on the agility of some collegiate deliberations.
- Pressure for Definition: The regulated sector manifests growing concern with the prolonged indefinition, which may affect regulatory predictability.
Practical Impacts: The prolonged maintenance of the status quo, beyond the initially anticipated timeframe, generates uncertainty for the regulated sector. The reduced composition of Anvisa’s board of directors may lead to a greater concentration of decision-making authority and potential delays in proceedings that require collective deliberation. For the market, the appointment of new leadership is essential to understanding the regulatory guidelines that will shape the coming years, particularly in light of the technical profiles of the nominees and their prior experience in the public sector.
Will the New Drug Price Regulations Arrive in 2025?
Initial Scenario (2025): We identified the urgent need for modernization of medicine price regulation, governed by a 2004 norm considered anachronistic by the market. We highlighted the exponential growth of biosimilars and gene therapies as catalysts for new regulations that would offer predictable criteria adequate for new technologies. We also mentioned CMED’s public hearing on reviewing its internal regulations. See the complete content here.
Recent developments:
- Public Consultation Launched: On May 5, 2025, CMED published Public Consultation 1,330/2025, opening a 60-day period for contributions on the proposed revision of Resolution 02/2004.
- New Categorization: The proposal expressly includes medicines with incremental innovation, non-new biological products and biosimilars, plus medicines resulting from ownership transfer.
- DIP Deadline: Establishment of a 60-day deadline from Anvisa registration approval for filing the Price Information Document (DIP) through electronic system.
- Country Basket Expansion: Expansion of reference countries for price comparison, including Germany, Norway, Japan, Mexico, South Africa, and product origin country.
- More Rigorous Criteria: Increase in minimum number of countries for comparison from three to five countries for definitive Factory Price approval.
- Contribution Deadline: Deadline established for July 10, 2025.
Practical Impacts: After decades of debate, 2025 effectively marks the year of modernization in the regulation of pharmaceutical pricing in Brazil. The proposed changes introduce stricter standards for international price benchmarking and formally acknowledge new categories of products that have emerged in the market. For the pharmaceutical industry, this translates into greater regulatory predictability, but also potentially more restrictive pricing criteria. The tight deadline for submitting the Drug Information Package (DIP) and the mandatory use of the electronic system will require significant operational adjustments by companies.
Cannabis
Initial Scenario (2025): We predicted that 2025 would be a decisive year for Brazil’s cannabis market, with expectations of industrial hemp regulation by MAPA and revision of RDC 327/2019 by Anvisa. We highlighted regulatory tension between RDCs 327/2019 and 660/2022, defended by Sindusfarma, and developments from the STJ decision that differentiated industrial hemp from psychoactive cannabis. See the complete content here.
Recent Developments:
- RDC 327/2019 Revision: Anvisa launched public consultation between March 28 and June 3, proposing important regulatory expansions.
- New Possibilities: The proposal includes expansion of administration routes, manipulation of magistral preparations, and authorization for importing extracts, CBD phytopharmaceuticals, and bulk industrialized products.
- Expanded Purposes: Authorization for importation for research, distribution, development, and manufacturing purposes on national territory.
- Interinstitutional Coordination: Confirmation that Anvisa and MAPA work on individual drafts to regulate hemp, following STJ determination.
- AGU Action Plan: On May 19, 2025, AGU filed a petition with STJ presenting an Action Plan for regulation and inspection of cannabis derivatives for exclusively medicinal purposes.
- Defined Timeline: Establishment of deadline until September 2025 for finalizing the regulatory draft.
Practical Impacts: Brazil’s medicinal cannabis sector is experiencing its greatest regulatory transformation since discussions on the topic began. The expansion of possibilities in RDC 327/2019 signals greater Anvisa openness for national market development, while AGU’s Action Plan demonstrates governmental coordination to implement judicial determinations.
Novel Foods and Ingredients
Initial Scenario (2025): We identified implementation challenges of RDC 839/2023, which established general and specific approvals for new ingredients, creating a system of confidential information protection versus public transparency. We highlighted the expectation of opening a public consultation in the first quarter for new normative instruction on specifications of unlisted ingredients, plus practical impacts of RDCs 843/2024 and IN 281/2024 on the dietary supplements sector. See the complete content here.
Recent Developments:
- Public Consultation Confirmed: Opening of Public Consultation 1324 with deadline until August 1, 2025, for new normative instruction on specifications of ingredients not contemplated in other lists.
- Persistent Challenges: Practical questioning and cancellations of dietary supplement notifications by Anvisa continue.
Practical Impacts: The public consultation confirmation offers the sector the opportunity to influence new ingredient specifications until August 2025, filling important regulatory gaps. Companies should prioritize active participation in this consultation while improving their processes to meet stricter criteria of current norms.
Discount Cards
Initial Scenario (2025): We identified ANS regulation of discount cards as one of the main developments of the regulatory sandbox, impacting a market of 4 to 5 million users. We highlighted the legal foundation based on STJ decision (AREsp 2,183,704-SP) that recognized ANS competence to inspect and regulate this segment. See the complete content here.
Recent Developments:
- Technical Chamber Established: ANS created a technical chamber to deepen proposal analysis after identifying divergences during Public Consultation No. 151.
- Suspended Deliberation: Final regulation remains suspended until the conclusion of pending judicial action regarding the agency’s competence to regulate discount cards.
- Awaiting Legal Security: ANS considers judicial definition an essential element to delimit boundaries between regulated and non-regulated models in supplementary health.
Practical Impacts: The regulatory process for discount cards is now in a judicial holding pattern, creating a period of uncertainty for a growing market. Although the technical chamber continues its studies, the lack of clarity regarding ANS’s regulatory authority leaves companies and users in a state of anticipation. For the sector, this means that investments and expansion strategies may be affected by the regulatory ambiguity until the judicial issue is resolved.
Financial Regulatory Mechanisms
Initial Scenario (2025): We highlighted modernization of financial regulation mechanisms through Public Consultation No. 145, with proposals to limit co-participation and deductibles (maximum 30% per procedure, monthly ceiling of 30% of monthly payment, annual limit of 3.6 times the monthly payment value) and exclusion of certain procedures like chronic disease therapies. See the complete content here.
Recent Developments:
- Judicial Suspension: Federal Court of DF injunction suspended the proceedings of Public Consultation No. 145, responding to Abramge’s action.
- AIR Requirement: Resumption conditioned on prior elaboration of Regulatory Impact Analysis and reopening for 90 more days.
- Individualized Treatment: The position gains strength that each topic should be treated separately due to complexity.
Practical Impacts: Judicial suspension creates a period of undefinition for operators and beneficiaries who awaited new co-participation rules. The AIR requirement may result in more robust analysis of economic impacts but also prolongs regulatory uncertainty in the sector.
Online Sales of Health Plans
Initial Scenario (2025): We identified the proposal to make online health plan commercialization mandatory, expanding beyond the current optional modality. The measure aimed to modernize the sector, expand access, and adapt to contemporary digital practices, maintaining coexistence with face-to-face channels. See the complete content here.
Recent Developments:
- Judicial Suspension: Federal Court of DF injunction suspended the proceedings of Public Consultation No. 145, responding to Abramge’s action.
- AIR Requirement: Resumption conditioned on prior elaboration of Regulatory Impact Analysis and reopening for 90 more days.
- Individualized Treatment: The position gains strength that each topic should be treated separately due to complexity.
Practical Impacts: The suspension postpones investments in technological adaptations by operators and maintains digital commercialization as an optional modality. The sector awaits definitions about timeline and scope of future obligation.
Plan Technical Review
Initial Scenario (2025): We predicted implementation of methodology for technical review of individual and family plan prices, allowing exceptional adjustments beyond IRPI for operators in economic-financial imbalance situations, with objective and transparent criteria. See the complete content here.
Recent Developments:
- Judicial Suspension: Federal Court of DF injunction suspended the proceedings of Public Consultation No. 145, responding to Abramge’s action.
- AIR Requirement: Resumption conditioned on prior elaboration of Regulatory Impact Analysis and reopening for 90 more days.
- Individualized Treatment: The position gains strength that each topic should be treated separately due to complexity.
Practical Impacts: Operators in financial imbalance remain without regulatory alternatives for exceptional adjustments, staying dependent on individual negotiations or judicial measures until regulatory process resumption.
Health plan adjustments and pricing policies
Initial Scenario (2025): We highlighted ANS proposals to improve adjustment regulations, including prohibition of accumulating financial and claims ratio indices, possibility of contract termination on an anniversary date, and grouping of collective contracts with fewer than 1,000 lives. See the complete content here.
Recent Developments:
- Judicial Suspension: Federal Court of DF injunction suspended the proceedings of Public Consultation No. 145, responding to Abramge’s action.
- AIR Requirement: Resumption conditioned on prior elaboration of Regulatory Impact Analysis and reopening for 90 more days.
- Individualized Treatment: The position gains strength that each topic should be treated separately due to complexity.
Practical Impacts: High judicialization of adjustments (75% of decisions favorable to consumers) continues without definitive regulatory solution. The suspension maintains the current scenario of conflicts and uncertainties, harming both operators and beneficiaries who awaited greater predictability.
Our Life Sciences & Healthcare team is available if you have any questions about these topics and their possible developments via email: lifesciences@soutocorrea.com.br.