Similar to an initiative from the National Health Surveillance Agency (Anvisa), which opened a Public Call for Subsidies (more information here), the National Regulatory Agency for Private Health Insurance and Plans (ANS) published a Public Consultation 138/24 on October 2 to collect suggestions regarding the proposed normative resolution that provides for the rules regarding experimental regulatory environments (regulatory sandbox). Contributions should be made through CP 138/24, from October 9 to November 22, 2024.

The regulatory sandbox is a controlled and experimental environment that allows companies and entrepreneurs to test innovations and new technologies in a flexible and supervised regulatory context. At the federal level, this is regulated by Complementary Law 182/21, which established the legal framework for startups and innovative entrepreneurship, allowing agencies (such as ANS) to not apply specific rules on the regulated business on an tentative basis.

Main aspects of the normative resolution

The creation of a regulatory sandbox by ANS is intended to facilitate the development of health solutions that are incompatible with the regulations in force. Its objectives are:

  • provide for the operation of the experimental regulatory environment;
  • define the criteria for selecting the initiatives to be tested or specific qualification that must be presented by the regulated parties;
  • determine the scope limitations;
  • provide for the duration and the requirements that may be waived; and
  • improve the regulations in force at the ANS.

The normative resolution provides for the subsequent call for participation that must contain, at a minimum:

  • the market segments that will be subject to the experimental regulatory environment and the rules that will be exempted;
  • the deadlines and procedures for selecting those interested in participating in the experimental regulatory environment;
  • the deadline for participation in the experimental regulatory environment, counting from the issuance of the temporary authorization by the ANS;
  • the eligibility parameters, form and criteria that will be used to select those interested in participating in the experimental regulatory environment;
  • the maximum number of participants that may be selected for the experimental regulatory environment; and
  • the scope of the experimental initiative.

The admission of projects will follow predefined criteria, requiring the product or service presented to be an innovative project that solves a problem and presents gains and benefits for the market and consumers.

In addition, the normative resolution stipulates that eligibility criteria must be met by participants, such as demonstrating sufficient technical and financial capacity to carry out the intended activity in an experimental regulatory environment.

A specific Sandbox Commission will be set up by the Agency to select participants and oversee activities related to the experimental regulatory environment.

ANS Public Consultation 138/2024

The purpose of CP 138/2024 is to collect contributions and help the agency define the best criteria for the ANS regulatory sandbox model.

Any interested party can contribute, including citizens, health professionals, entrepreneurs, microentrepreneurs, startups, associations and representative entities of the regulated business, non-governmental organizations, public institutions, class councils, educational and survey institutions and others government agencies.

The information collected through the contributions will be used to adjust and/or improve the text of the normative resolution already issued by the agency.

The Life Sciences & Health practice  can provide more information on the topic.