17 Trends for the healthcare market in 2025
Another year begins, and one of the questions we always receive is: what should we keep an eye on this year?
Well! Looking back at 2024, we put our crystal ball to work, and our Life Sciences & Healthcare team has listed 17 relevant topics (and there could be more) that sectors regulated by the National Health Surveillance Agency (“Anvisa”) and the National Regulatory Agency for Private Health Insurance and Plans (“ANS”) should pay attention to.
For easy reference and access, the 17 topics are:
1. National development strategy for the Economic-Industrial Health Complex (“CEIS”): PDPs and PDILs
3. Anvisa’s administrative sanctioning procedures
4. Regulatory Sandbox: ANS and Anvisa
5. New composition of the Boards of Directors: Anvisa and ANS
7. Pharmaceuticals’ price regulations
9. Cannabis
10. GMPc inspections
11. Novel foods and ingredients
12. Tecnovigilance: the post-market of medical devices
13. Discount Cards
14. Financial Regulatory Mechanisms
15. Online Sales of Health Plans
17. Health plan adjustments and pricing policies
1. National Development Strategy for the Economic-Industrial Health Complex (“CEIS”): PDPs and PDILs
Relaunched at the end of 2023, the Partnerships for Productive Development (“PDPs”) involve the transfer of technologies from private institutions to public laboratories, for the local production of medicines to reduce the vulnerabilities of the Brazilian Public Health System (also known as SUS). Although not an unprecedented subject in Brazil, the resumption of PDPs was guided by an audit by the Federal Audit Court (“TCU”) carried out in 2017 (but with results released in September 2023), in which indicated several gaps in the previous regulation that needed improvement, such as the provision of objective criteria to define strategic products, as well as the selection of partners.
Also, part of CEIS, it was also launched the Local Development and Innovation Program (“PDIL”). Unlike PDPs, which aim to transfer already known technologies from private laboratories, PDIL aims to foster the local development of innovative solutions.
In September 2024, the Ministry of Health (“MoH”) received 175 PDIL and 147 PDP proposals, which are currently under analysis. The announcement of the proposals that will be implemented is expected throughout 2025.
2. “Judicialização”of Health
In Brazil, the Judiciary also plays an important role in health issues, with patients often suing the government or insurers for the adjudication of their constitutional rights. This phenomenon in Brazil called “Judicialização” and it cost the MoH more than BRL 2 billion (US$ 317 million) in 2024 and private insurers BRL 15 billion (US$ 2.3 billion) over the last four years.
In September 2024, the Supreme Federal Court (STF) concluded the rulings on 2 themes of general repercussion[1], addressing important issues:
- The obligation of the government to provide drugs not reimbursed by SUS, regardless of their cost (known as “Theme 6”).
- Which federative entity (Union, States or Municipalities) should bear the costs of the judicialization of health, in addition to aspects related to the passive procedural legitimacy of the Union in lawsuits related to the supply of medicines (“Theme 1234”).
Theme 6 (or Binding Precedent 61) defined stricter criteria to be observed by the Courts for the granting of medicines, thus expecting more difficulty for patients in accessing treatments. The highlights of such criteria are the need to establish the illegality of the negative Health Technology Assessment (HTA) decision of CONITEC/SECTICS (HTA authorities in Brazil), as well as to demonstrate high-quality scientific evidence, such as randomized clinical trials, systematic reviews or meta-analyses.
A topic that draws attention regarding Theme 1234 (or Binding Precedent 60) is the possible literal interpretation that drug suppliers must honor discounted prices proposed in HTAs before CONITEC, even in case of different conditions considering what was assessed during the HTA.
There are still definitions regarding the Themes, either due to Motions of Clarification filed against Theme 6, or due to the still pending creation of a national platform that will centralize court orders involving the acquisition of medicines by the SUS. On the one hand, given the criteria currently established for granting access to medicines, there is a perception that judicialization will require greater governance and organization. On the other hand, the first feeling for the plaintiffs is that “the bar has been raised” and could generate disproportionate consequences that will require review.
3. Anvisa’s Administrative Sanctioning Procedures
Open from December 20, 2024, to February 2, 2025, Public Consultation 1297/2024 discusses a proposed Resolution on the guidelines to be observed in Anvisa’s Administrative Sanctioning Procedures (also known as “PAS”), applicable to all sectors regulated by the Agency.
The initiative to regulate PAS was expected, especially due to the TCU audit concluded in 2020 related to the topic.
The draft proposed by Anvisa brings important changes to the current procedure that may affect the regulated sector, including:
- The express provision of “non-admission” of the suspensive effect of appeals filed against Anvisa’s precautionary measures.
- The regulation of the Conduct Adjustment Declaration (“TCAC”) within the scope of the PAS.
- Greater clarity on the fine definition, with the publication of a table with minimum and maximum values which considers (i) company size, (ii) nature of the infraction and (iii) risk for the public. However, the practical characterization of the risk and nature remains discretionary and linked to the officials involved in the analysis. Thus, adjustments are necessary to enhance the clarity of the proposed rule.
- The express provision that PAS is a responsive inspection. In other words, it must consider the proportional and efficient selection of administrative measures, the health risk involved, the precedents history of the offending company and the need to prevent or mitigate health risks.
This will certainly be a topic of great importance for the sector in scenarios where discussions of possible violations are taking place, as it provides greater predictability and proportionality to the penalties, although the proposal may be improved based on the best practices adopted by other regulatory agencies.
4. Regulatory Sandbox: ANS and Anvisa
In December 2024, through Normative Resolution 621, ANS regulated the Regulatory Sandbox in supplementary healthcare, through which ANS temporarily suspends or relaxes the obligation to comply with standards, to allow companies to test innovative products and services
The regulation establishes that the implementation of the regulatory sandbox will be linked to the proof of the need for a supervised environment, is focused on the development and assimilation of innovations in the supplementary health sector. Once these procedures are completed, temporary authorizations will be issued to participants, with an initial duration of up to 24 months, extendable for another 12 months. Admission will be formalized through the signing of a Specific Admission Term, which will define the conditions applicable to the period of implementation.
In turn, Anvisa published in September 2024 the Partial Report on Regulatory Impact Analysis on the Sandbox within its scope, opening a period for contributions in public consultation. In December 2024, Anvisa launched Directed Consultation 04/2024 – open until January 31, 2025 – which aims to receive contributions on the draft call for the selection of participants in the Regulatory Sandbox Pilot Project aimed at Personalized Cosmetic Products.
With such initiatives, to be improved throughout 2025, it is expected:
- Greater incentive for innovation in health.
- Faster and less costly development of new products and services.
- Maintaining the technical and regulatory rigor of agencies, so that they can fulfill their institutional missions of protecting the health of Brazilians, without hindering new realities.
5. New composition of the boards of directors: Anvisa and ANS
With interim members for almost one year and a half and currently with only two effective members, the Anvisa board of directors, which is composed of five directors, has three professionals appointed by the President of the Republic. These appointments must be reviewedand approved by the Federal Senate in 2025.
Regarding ANS, it is worth mentioning the nomination of Mr. Wadih Nemer Damous Filho, current head of the National Consumer Secretariat (Senacon), who has been nominated for President of ANS.
There is still no news about the dates for the hearings of the nominees in the Federal Senate, a mandatory step for the appointments to be finalized.
6. Clinical trials
After nine years of discussion in the National Congress, Law 14.874 was published, regulating clinical trials in Brazil.
Previously treated as an infra-legal matter, the new law establishes rules to be followed in clinical trials, including the creation of the “National System of Ethics in Research involving Human Beings”, parameters for the protection and remuneration of research participants, and the responsibilities of the researcher and sponsor.
An important highlight was the President’s veto regarding the maximum period of five years for the post-study supply of experimental drugs, counting from the date they are commercially available in the country. This veto was criticized by sectors, such as patients’ associations and industry, given that maintaining post-study access for an indefinite period could discourage trials in Brazil, especially the one focused on rare and ultra-rare diseases.
The market awaits, in 2025, both the analysis of the vetoes by the National Congress and the regulation of the law aiming to bring greater clarity and detail to the national authority that will regulate the topic, as well as the obligations and procedures established.
7. Will the new drug price regulations arrive in 2025?
For years, the market has been discussing the anachronism of price regulation, governed by a 21-year-old norm. Several proposals have already been presented and debated over the last two decades, without any concrete progress. On the other hand, with the exponential growth of biosimilars and gene therapies, it has become clear the impossibility of moving towards a sustainable healthcare model without regulation that provides predictable criteria in line with new technologies and contract models.
Additionally,, in December 2024, CMED held a public hearing to present a proposal to revise its internal regulations, currently outlined in Resolution 3/2003 and opened an opportunity for contributions.
The objectives of the review are, among other things, to update the competencies and attributions of the bodies that constitute CMED, to provide predictability to the entity’s processes, and to expedite analysis through mechanisms such as “block” decisions and virtual deliberations.
8. Plant-based products
Plant-based products are a worldwide reality, and Brazil is no different. These foods, made from plant raw materials that simulate the sensory and functional characteristics of animal products, have gained prominence in the Brazilian market due to the growing demand for sustainable and innovative alternatives.
After launching a public consultation on the subject in 2023, the Ministry of Agriculture (“MAPA”) held a public hearing in September 2024 to discuss the specific regulation of these products.
The meeting was widely attended by representatives of the regulated sector (animal and plant-based products) and government bodies, , with MAPA and Anvisa’s technical collaboration being a highlight.. During the event, topics such as labeling, identity and quality standards, and the regulatory requirements of these products were discussed.
After consensus adjustments at the event, MAPA has finished the regulation’s draft, which is now undergoing internal procedures for publication.
The expectation is that 2025 will bring the first formal regulation of the sector, establishing clear guidelines for the labeling, registration, and inspection of similar plant products.
9. Cannabis
The year 2024 brought important milestones for the cannabis market in Brazil, including a decision by the Brazilian Superior Court of Justice (“STJ”), which differentiated industrial hemp from psychoactive cannabis, allowing the economic exploitation of industrial hemp for medicinal and pharmaceutical purposes.
As a result of the STJ’s decision, MAPA is expected to publish regulations on industrial hemp in 2025, expanding its use beyond medicinal and pharmaceutical purposes.
In parallel, Anvisa is expected to review RDC 327, whichestablishes strict manufacturing and control standards for cannabis products, opening opportunities for regulatory adjustments and greater integration between the demands of the pharmaceutical industry and the cannabis market.
10. GMPc Inspections
In recent years, Anvisa has sought support from state and municipal health departments to decentralize inspection and health monitoring activities, corroborating the commitment made more than five years ago through Normative Instruction 32/2019.
Additionally, the lack of human resources at Anvisa has been a challenge for meeting deadlines and perform inspections.
To address this, Anvisa published a series of ordinances delegating the authority to local inspection agenciesto verify compliance with Good Manufacturing Practices (“GMP”) for medical devices of classes III and IV (high and very high risks), and medicines (except medicinal gases).
The objective is for local authorities to be able to issue GMP reports and certificates for companies located in their jurisdictions. Local authorities in six states have already received this delegation.
The expectation is that in 2025 the publication of GMP Certificates and business operating authorizations (“AFEs”) will be faster and that there will be better harmonization between the inspections carried out by local authorities and Anvisa.
11. Novel Foods and Ingredients
Anvisa’s RDC 839/2023 came into force on March 16, 2024, and established:
- General Approvals for ingredients which, due to their manufacturing, study and approval characteristics, allow different companies to market them.
- Specific Approvals when the key information for evaluating the ingredient is confidential, granting exclusivity to the company that supported the ingredient’s approval with its dossier.
Anvisa has recognized that transparency is an essential rule for maintaining consumer confidence; however, it is equally important that companies protect their significant investments in R&D, formalized in the documents submitted for Anvisa’s approval.
Therefore, confidentiality petitions became essential in 2024 to ensure protections for trade secrets during and after the conclusion of the evaluation process.
The expectations for 2025 reflect the uncertainty about how confidential information will be safeguarded by Anvisa and how other information will be disclosed to the public.
A Public Consultation is expected to be opened in the first quarter of 2025 for a new Normative Ruling that will contain the specifications of novel ingredients not included in other lists.
Regarding Anvisa’s RDC 843/2024 and IN 281/2024, both brought updates and alignment of pre-market control of foods based on risk criteria, especially for regularization through (i) registration with Anvisa, (ii) notification with Anvisa, and (iii) communication to local health surveillance authorities.
The challenges especially impact on the food supplement categories, as the notifications have raised some practical questions and resulted in cancellations by Anvisa due to the lack of stability studies, the use of unauthorized ingredients, and other alleged non-conformities.
For 2025, the food industry needs to be attentive to the changes and the practical effects of these changes, remaining open to dialog with Anvisa and intensifying adaptation to the new standards and regulatory requirements.
12. Tecnovigilance: the post-market of medical devices
Issues involving post-market actions are increasingly present in the routine of companies, especially in the medical device sector. During Hospitalar in May 2024[2], inspectors from the Anvisa’s Technovigilance Management commented on some changes in the standard that would be proposed for the regulated sector.
The main objective is to harmonize the guidelines of the International Medical Devices Forum Regulators (IMDRF), including the possible implementation of specific post-market inspections focused on technovigilance procedures.
Even without specific regulatory changes, it is already possible to observe some inspections being carried out by Anvisa with the focus of evaluating the implementation of technovigilance in companies.
The promise for 2025 is the publication of a Public Consultation aiming to update post-market standards to reflect this new approach.
13. Discount Cards
One of the most significant developments stemming from the regulatory sandbox established by ANS concerns the regulation of discount cards within the scope of supplementary health care. This segment has shown significant growth in recent years, and now accounts for approximately 4 to 5 million users in Brazil.
The decision to advance the regulation of this matter was based on the understanding consolidated by the STJ in the judgment of the Internal Appeal (AREsp 2.183.704-SP), under the reporting of Justice Herman Benjamin. In this ruling, it was recognized that ANS has the authority to supervise and regulate discount cards, given the connection to the supplementary health care sector.
As highlighted by the decision, even though prepaid health cards as discount cards are not included in the definition of healthcare plans, they constitute a legal relationship between consumers and providers of medical services. This dynamic closely aligns with activities regulated by the legislation applicable to the supplementary health care sector, particularly regarding consumer protection and ensuring access to quality medical services.
Thus, throughout 2025, we should expect developments regarding the definition and regulatory parameters that will guide the operation of discount cards in Brazil.
14. Financial Regulatory Mechanisms
In 2025, the modernization of financial regulatory mechanisms stands out in the supplementary health care sector, as outlined in Public Consultation 145, promoted by ANS. Among the proposed changes, the establishment of limits for copayments and deductibles applicable to healthcare plans’ beneficiaries is notable, aiming to balance financial sustainability with consumer protection. The proposals include:
- A maximum copayment rate of 30% per procedure performed.
- A monthly cap of 30% of the contracted premium.
- An annual limit equivalent to 3.6 times the premium amount.
Additionally, the exclusion of certain procedures from copayments and deductibles is proposed, such as therapies for chronic diseases and hemodialysis sessions.
Although these changes aim to strengthen consumer protection and ensure greater predictability in the funding of services, they raise concerns about the financial impact on healthcare plans operators, particularly in high-risk portfolios. Moreover, the implementation of the new rules may foster litigation, worsening the scenario of disputes in the sector.
To mitigate adverse effects, it is expected that the implementation of these measures will occur gradually, accompanied by continuous monitoring of the operators and the market.
15. Online sales of health plans
The digitalization of the supplementary healthcare market has established itself as an irreversible trend. Since the enactment of Normative Resolution 413/2016, the ANS has regulated the electronic sales modality, establishing guidelines for operators to provide clear, precise, and accessible information to consumers. To date, the offering of health plans through digital platforms remains optional, coexisting with in-person channels.
The ANS’s new initiative aims to make online commercialization mandatory for health plan operators, seeking to expand consumer access, provide greater convenience during the contracting process, and align the sector with contemporary digital practices. Nevertheless, there is no indication that traditional channels, such as in-person sales, will be discontinued. On the contrary, the coexistence of diversified modalities is envisioned to ensure consumer freedom of choice and to respect different audience profiles.
While this mandatory measure represents a significant step toward modernizing the sector, it imposes important challenges, especially for operators that have not yet adopted digital sales. Technological adjustments, investments in team training, and compliance with specific regulatory requirements will be necessary.
Moreover, the obligation requires attention to information security, transparency in data provision, and ensuring the usability of digital platforms—crucial factors for maintaining consumer trust and the functionality of the model.
Considering this proposal, it is essential that the sector closely monitors regulatory developments, analyzes the obligations that will be imposed, and plans the necessary adaptations for its effective implementation.
16. Plan technical review
The ANS is planning to implement a methodology in 2025 aimed at the technical review of individual and family health plans. The initiative seeks to provide greater economic and financial balance to operators facing exceptional situations of imbalance, in addition to the annual adjustments calculated based on the Individual Plan Adjustment Index (IRPI).
The proposal includes the possibility of applying exceptional adjustments, conditioned on the operators proving economic imbalances that compromise the plan’s sustainability. To this end, ANS intends to develop objective, clear, and transparent criteria to regulate the procedures for requesting, calculating, and implementing these adjustments.
Among the points to be regulated are the documentary requirements, the economic and actuarial metrics that will support the evaluation of requests, as well as the limits for applying these adjustments to safeguard consumer rights.
The criteria and standards are still in the formulation phase and will be presented during public hearings promoted by ANS. The expectation is that the new regulation will be finalized and published by the end of 2025, with implementation scheduled for January 2026.
17. Health plan adjustments and pricing policies
Adjustments in health plans remain one of the most debated issues in the supplementary health care sector, representing one of the main factors driving litigation. Data presented by the Brazilian Institute for Consumer Defense (“Idec”), through Letter 59/2023/Coex, shows that, in an analysis of 113 judicial decisions issued by 11 courts between 2014 and 2017, the questioned adjustments averaged 89%. Moreover, in 75% of the cases analyzed, the Judiciary rejected the application of the adjustments, favoring the contracting parties.
In response to this scenario of disputes, ANS is starting the year with proposals to improve the regulation of adjustments applied to health plans. Among the main proposed changes, the following stand out:
- Prohibition of combining financial adjustment rates and claims ratio adjustments.
- Possibility of terminating collective contracts on their anniversary date.
- Grouping of collective contracts with fewer than 1,000 beneficiaries.
The proposals presented by ANS demonstrate an effort to mitigate conflicts related to adjustments and reduce litigation in the sector, seeking a greater balance between the financial sustainability of operators and consumer protection. However, these changes will also require adaptations by operators, especially in implementing stricter criteria for managing and calculating adjustments.
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.
[1] Extraordinary Appeals 1.366.243 e nº 566.471.
[2] Organized by Informa Markets, Hospitalar is one of the most important business and healthcare content events in Latin America.