Around the Globe: Latin America

Good Regulatory Practices: ANVISA’s Regulatory Model for Brazil
Gabrielle C B C e Cysne Troncoso
Daniel M. Mota
Brazilian Health Regulatory Agency – ANVISA
Cammilla H. Gomes
Alice Hamahiga

ntroduction: In the past twenty years, the Brazilian regulator ANVISA has been increasingly working to improve regulatory processes and gain credibility in the field of health regulation. The Agency’s current position as a regional and global leader is the result of different efforts, and this article brings information about one of them – its adoption of Good Regulatory Practices.

The normative acts referred to below are any decisions enacted by ANVISA establishing norms, rules, standards or obligations. These include, among others, Resolutions, Norms, Normative Instructions, or Joint Acts with other government bodies.

The Brazilian Health Regulatory Agency (ANVISA) is an autonomous organization linked to the Ministry of Health and is part of the National Health System (SUS) as coordinator of the Brazilian Health Regulatory System (SNVS). ANVISA’s role is to promote the protection of the population’s health by controlling the production, marketing, and use of products and services subject to health regulation.

ANVISA’s current regulatory model has been in force since April 2019 as a means to improve Brazil’s health standards. This model changed the way of addressing development and review of normative acts by simplifying internal work processes, further encouraging regulations based on scientific and technical evidence, and enhancing social engagement. The introduction of this model is linked to ANVISA’s Strategic Planning, enabled by improvements introduced by the Agency during the past decade (such as the Regulatory Agenda [RA]) and optimized by tools that provide transparency to regulatory activities such as the Health Regulation Observatory.

Increased Focus on Regulatory Quality

Regulatory processes in ANVISA are a constant cycle of planning, intervention, stock management, monitoring, and outcome analysis. This cycle was positively impacted by model introduced in 2019, centered on strengthening the use of Regulatory Impact Analysis (RIA), an internationally recognized tool aimed at improving the quality and efficiency of regulation by providing greater technical and analytical robustness to decision making.

In ANVISA’s regulatory model, RIA consists of a systematic evidence-based analysis process that seeks to assess, based on the definition of a regulatory problem, possible impacts of alternatives available to achieve intended regulatory objectives. Its purpose is to guide and subsidize decision making, and ultimately to contribute to regulatory actions that are effective and efficient. RIA contributes to transparency of regulatory processes and to the dialogue between government, the regulated sector, and society.

RIA must precede all proposals for the adoption or amendment of normative acts in ANVISA, and can be dismissed only upon justification (i.e., in cases with high degree of urgency and seriousness that imply need for immediate action; revisions of normative acts that aim exclusively at administrative simplification; and standard acts that have a known low impact). Every RIA prepared by the Agency since 2012 is available online.

A specialized internal ANVISA office provides advice to technical areas: promotion of internal workshops for regulatory problems definition and analysis; identification and comparison of advantages and disadvantages for regulatory options; stakeholder mapping; and definition of regulatory outcomes.

Another important aspect of this regulatory model is its use of the Monitoring and Analysis of Regulatory Outcome methodology with the purpose of observing whether the objectives originally proposed by the regulation have been achieved. This model provides rationality to regulatory processes by considering the most impactful regulatory options for society with the intention of changing the behaviors of affected stakeholders. This means that, in order to face a certain problem, the most effective option in terms of cost/benefit may be not to adopt any regulatory measure and thus not interfere with the market.

Social Engagement Throughout the Regulatory Cycle

This regulatory model values diversification of social participation mechanisms to allow greater interaction between ANVISA, other government agencies, industry, society, and institutions dedicated to consumer education and protection. The model introduced the possibility for “Public Call for Input,” an opportunity for stakeholders to debate ANVISA technical documents, such as the preliminary RIA report. Additionally, under the new model, the standard period for public consultations is at least 45 days (60 days in the case of consultations on matters of international impact). ANVISA’s new regulatory model strengthens social engagement throughout the regulatory cycle, not only during the public consultation phase. The broad range of possibilities to interact with the Agency during regulatory processes is described in the Menu of Social Engagement.

Improving Regulation: ANVISA Strategic Planning

The first movement toward a strategic positioning of ANVISA occurred in 2010, when the Agency established a long-term vision, over a ten-year horizon. From there, ANVISA set specific objectives, projects and goals, summarized in a strategic map. In 2019, ANVISA started a new cycle of updating the strategy and in 2020 launched the Strategic Plan 2020-2023, with 15 Strategic Objectives. Improving regulatory quality is one Objective (Objective 9) and focuses on consolidating the implementation of Good Regulatory Practices by ANVISA to keep the Brazilian regulatory framework up to date and improving the technical consistency and quality of regulation. Goals for this 2023 Objective include achieving 100% RIA for ANVISA regulations not exempted from RIA, as well as that 90% of the normative acts published by the Agency as a result of the Regulatory Agenda.

Planning Regulatory Actions with ANVISA’s Regulatory Agenda

The RA is a tool for planning regulatory action on priority topics for a given period. Its main objective is to improve the health regulation framework, promoting transparency and predictability for industry and citizens alike. Normative acts or non-normative regulatory instruments (guidelines, manuals, Q&A documents, etc.) result from development and discussion of topics included in the RA. Inclusion of a topic in the RA is usually the first stage of the regulatory process.

The first RA was approved in 2009. ANVISA’s work is currently based on the Regulatory Agenda 2017-2020. Its structure is based on the PCDA model (Plan – Do – Check – Act or Adjust), focusing on the regulatory planning of each topic. The Agenda undergoes annual updates to approve the inclusion, exclusion and change of priority topics; subject to specific criteria, out-of-cycle updates may occur. RA 2017-2020 has more than 120 themes organized into 15 macro themes, with each macro theme corresponding to an ANVISA area of action.

Promoting Visibility with the Health Regulation Observatory

The Health Regulation Observatory is a virtual space to disseminate information of interest in health regulation, and aims to provide for and encourage the improvement of regulatory quality. It affords more visibility into ANVISA’s regulatory performance; facilitates and strengthens social participation; and systematizes regulatory data produced by different sources. It currently includes four informative “panels” regulatory processes; network of normative acts, imported products, and regulatory stock management.

Our Way Forward

ANVISA is constantly simplifying regulations and improving the transparency of its actions, providing opportunities for stakeholders to access information in an easier and more agile way, and creating tools for monitoring regulatory performance and processes. These measures aim at further promoting compliance to regulatory standards and improving the healthcare business environment in Brazil.

Implementation of Good Regulatory Practices by ANVISA is evolving, and the Agency’s recent publication of additional tools to deliver information about regulatory stock management is a clear sign that the Agency will continue to pursue systematic improvement in the quality of the regulatory framework in Brazil.

Disclaimer: The opinion expressed in this article are solely the authors’ and do not represent the views of their organizations.