Regulatory sandbox: everything about Anvisa's proposal

On August 9, 2024, the National Health Surveillance Agency (Anvisa) published a Notice announcing the Agency’s intention to receive contributions on their partial regulatory impact analysis (RIA) report for the implementation of a regulatory sandbox model. Contributions to Anvisa's sandbox proposal can be submitted through the Public Call for Subsidies 9/24 (TPS 9/24) from August 12 to October 11.

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 Brazilian federal level, this environment is regulated by Complementary Law 182/21, which established the legal framework for startups and innovative entrepreneurship and allows Public Administration, including agencies (such as Anvisa) and public entities not to apply specific rules on the regulated business on an tentative basis.

While implementing the regulatory sandbox, the agency must:

• 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
• create mechanisms for monitoring and evaluating results.

Main aspects of partial RIA

The implementation of a regulatory sandbox model for Anvisa is topic 1.5 of the agency's regulatory agenda for the 2024–2025 cycle and is part of Anvisa's Strategic Plan 2024–2027 (Project 7 – Agile Regulation).

The initiate was motivated due to the agency's difficulty in providing adequate regulatory treatment to opportunities for development, production, and commercialization of innovative health-related products and services, in cases where the regulatory framework in force makes it impossible to obtain evidence to regulate these matters.

According to RIA’s partial report, Anvisa's difficulty is caused, among others, by the following factors:

• Agency’s technical team does not have legal certainty to release innovative products and services that challenge the rules in force without strong evidence of safety;
• insufficient evidence for the proper treatment of innovative products and services;
• lack of tools and workflow for the proper treatment of innovative products and services;
• adequate treatment of innovative products and services competes with priority actions of Anvisa's units;
• lack of trained staff to deal with innovative products and services from a regulatory perspective;
• proper treatment of innovative products and services requires significant investments of time and resources;
• Anvisa's internal regulations do not provide for the approval of testing environments for new technologies based on innovation;
• The speed of innovation in the production sector outstrips the regulator's ability to keep up with the sector.

Anvisa is now considering the creation of their own regulatory sandbox environment, taking into account aspects such as antitrust , stakeholders' involvement in the process, the time it takes to complete the process, regulatory quality gains, integrity risks, judicialization risks, among others.

Anvisa's suggested sandbox flow prototype is as follows:

• Entry mechanisms:
  • definition of the general conditions and scope of Anvisa's regulatory sandbox;
  • construction of the public notice template; and
  • preliminary analysis of the candidates.
• Removal of rules and definition of custom requirements:
  • detailed analysis of the proposals;
  • construction of the customized pathway; and
  • granting temporary authorization.
• Monitoring the experimental environments and adjusting requirements.
• Exit mechanisms: transition considerations and exiting the sandbox.

Public Call for Subsidies 9/24

The goal of TPS 9/2024 is to gather data and information from the interested stakeholders to assist Anvisa in making decisions regarding the RIA process and the implementation of the Agency’s 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 validate data and conclusions of the partial RIA report and to consolidate the final RIA report at a later date.

Anvisa's Board of Directors will make its decision on the subject based on the final RIA report to be prepared. According to the implementation plan released in the partial report, the following is expected:

• A proposal for a collegiate board resolution (RDC) will be drafted, including studies to compile a list of priority topics;
• An assessment of the administrative burden of a sandbox for Anvisa will be conducted;
• a pilot will be carried out to validate of the prototype and to develop procedures, as well as document models; and
• a final RDC on the subject and an orientation manual will be issued, along with communication and training plans for internal and external stakeholders.

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