Private Health in Brazil Regulatory Changes Analysis

Potential Regulatory Changes

The private health industry in Brazil operates within a dynamic and complex regulatory environment, primarily shaped by the Agência Nacional de Saúde Suplementar (ANS) and the Agência Nacional de Vigilância Sanitária (ANVISA). Several potential regulatory changes and ongoing challenges within these bodies could significantly impact the value chain in the near future.

One of the most critical challenges is the severe staff shortage at ANVISA. The agency is operating with less than half the necessary personnel, with a significant number of employees eligible for retirement. This shortage has already led to increased review times for submissions, potentially creating bottlenecks in the approval process for new medicines and medical devices. While ANVISA conducted a hiring competition in early 2024 and requested more positions for 2025, the deficit is expected to persist, impacting the timely availability of innovative health products in the Brazilian market. To address this, ANVISA is advancing authorizations based on assessments from Equivalent Foreign Regulatory Authorities (AREEs), which is anticipated to help decrease the review burden.

Within ANS, several regulatory initiatives are underway or expected. There is an ongoing focus on the financial regulatory mechanisms for health plan operators. Additionally, discussions continue regarding health plan adjustments and pricing policies. The agency is also exploring the implementation of a regulatory sandbox focused on the supplementary health sector to encourage innovation, with temporary authorizations for participants expected. Furthermore, there is an expectation for new developments in the legal field concerning the criteria for incorporating new technologies and therapies into the mandatory coverage list for health plans (Rol de Procedimentos), driven by the need for clear and objective criteria for predictability regarding coverage. Law 14.454/2022 already established that the "ANS Rol" is a minimum coverage list, and therapies not on the list may be eligible for reimbursement if they demonstrate clear benefits or are recommended by CONITEC or other renowned international HTA agencies.

ANVISA is also working on updating administrative sanctioning procedures, aiming for greater clarity and transparency in the application of penalties. A proposed Resolution on these guidelines was under public consultation. Additionally, ANVISA published a Normative Instruction in February 2025 establishing an optimized analysis procedure for the food industry using assessments from foreign equivalent regulatory authorities, a move that could potentially be mirrored or influence processes for other regulated products in the future. There is also a renewed bilateral cooperation between ANVISA and the Danish Medicines Agency, including technical exchange activities on topics such as inspections of good clinical practices and medical devices, clinical performance studies, and the use of artificial intelligence in regulatory processes.

The discussion around value-based healthcare payment models, while not solely a regulatory change, is a significant trend that the regulatory agency (ANS) has begun discussing and is expected to influence future regulations and contractual relationships between operators and providers.

Potential Impact of Regulatory Changes

Potential Regulatory Change / Issue	Value Chain Step(s) Impacted	Potential Impact
ANVISA Staff Shortages	Supply of Health Products and Technology, Distribution	Delays in approval of new pharmaceuticals and medical devices, potentially limiting access to innovative treatments and impacting market entry for manufacturers and distributors. Bottlenecks in inspections and border control.
Increased Use of AREE Assessments by ANVISA	Supply of Health Products and Technology, Distribution	Potential acceleration of the approval process for products already approved by recognized foreign regulatory authorities, facilitating market entry and access to innovative products.
ANS Regulatory Sandbox for Supplementary Health	Financial Intermediation, Healthcare Services, Complimentary Services	Encouragement of innovation in health plan products, service delivery models (including digital health and value-based care), and partnerships between operators and other players.
Evolution of ANS Rol and Technology Incorporation Criteria	Financial Intermediation, Healthcare Services, Supply of Products & Technology	Changes in mandatory coverage requirements for health plans, potentially increasing access to new therapies and procedures but also impacting the financial sustainability of operators. Increased clarity or new challenges in the Health Technology Assessment (HTA) process.
Updates to ANVISA Administrative Sanctioning Procedures	All steps involving ANVISA-regulated activities	Potential for increased transparency and legal certainty in the application of penalties for non-compliance, but also potential for stricter enforcement or changes in compliance requirements.
Focus on Value-Based Healthcare Payment Models	Financial Intermediation, Healthcare Services	Shift away from traditional fee-for-service models towards performance-based payments, potentially impacting provider revenue cycles, encouraging efficiency, and requiring new contractual arrangements and data sharing.

References

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