ANS publishes resolution on experimental regulatory environment – the Regulatory Sandbox

On December 16, 2024, the Brazilian Supplementary Healthcare Agency (ANS) published Normative Resolution No. 621/2024, which provides for the rules on the establishment and operation of the ANS experimental regulatory environment (Regulatory Sandbox). 

The initiative aims to foster the development of innovative solutions, reduce costs and maturation time, improve the current regulatory framework, and stimulate competition within the sector.

The resolution entered into force on its date of publication and enables companies to test new services, products, or technologies with temporary authorizations, fostering innovation and the adaptation of innovative solutions for the market.

We highlight the resolution’s following conditions:

1. Selection process

The selection process begins with a participation notice published by the ANS, which must provide for the following:

• • the purpose;
  • market segments;
  • participation term;
  • eligibility criteria;
  • maximum number of participants;
  • geographical and/or volume and scale limitations;
  • metrics for measuring expected benefits;
  • potential risks; and
  • administrative penalties in the event of non-compliance.

In addition, the notice draft will be submitted to public consultation after the Federal Prosecutor General’s analysis.

2. Eligibility criteria

Eligibility criteria for interested companies are:

• • Having the technical and financial capacity to perform the target activity within the Regulatory Sandbox;
  • Not being banned from participating in bids or receiving concessions, permissions, or authorizations from the government due to disreputable status or authorization revocation in the last five years.

3. Specific Term of Admission

Temporary authorizations will be granted after deliberation by the ANS’ Collegiate Board and upon the execution of a specific term of admission. This term will qualify the participant, the authorized activity and applicable regulatory exceptions, and the beginning and conclusion of the Regulatory Sandbox, among others.

In addition, the Regulatory Sandbox term can be exceptionally extended for up to 12 months upon ANS’ approval. 

4. Termination

The Regulatory Sandbox will end when:

• • The sandbox term ends;
  • The participant requests to exit the sandbox while complying with its contingency plan according to the resolution;
  • The ANS cancels the authorization; or
  • The ANS grants permanent authorization for the sandbox’s purpose.

In addition, the ANS may suspend or cancel the Regulatory Sandbox project unilaterally if:

• • The participant fails to comply with the specific term of admission;
  • There are operational flaws not cured within the term set by the ANS;
  • There are excessive unforeseen risks;
  • The participant fails to meet the eligibility criteria; or
  • There is evidence of irregularities.

The Regulatory Sandbox’s introduction represents significant progress for the supplementary healthcare market. With more flexible rules and a controlled testing environment, the ANS is establishing a more dynamic landscape that stimulates the development of more efficient and accessible solutions.

Demarest’s Life Sciences and Healthcare team is available to provide any further clarifications that may be necessary.