Saturday, July 13, 2024

Surveillance and Inspection System Overhaul: Anvisa Releases Impact Report on SNVS Decentralization

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National Health Surveillance Agency (Anvisa) has released the Regulatory Impact Analysis (RIA) Report on guidelines for organizing the National Sanitary Surveillance System (SNVS) and decentralizing inspection and surveillance actions carried out by the Union, states, Federal District, and municipalities. The document is part of the revision process for Resolution RDC 560/2021, aiming to address regulatory issues such as overlapping competencies among federal entities and improving the delegation of responsibilities for decentralized sanitary surveillance actions.

The RIA Report identifies several regulatory challenges that need to be addressed to enhance the effectiveness of the SNVS. These challenges include ineffectiveness in organizing and coordinating the current system, which struggles with decentralizing sanitary surveillance actions across different levels of government. Additionally, there is a lack of sufficient operational capacity and resources to effectively execute decentralized sanitary surveillance actions.

The essential methods and instruments for Quality Management and Sanitary Risk Management have not been fully implemented across the SNVS, hindering effective coordination and planning. Moreover, there is a significant gap in the interface for data sharing among the various systems used within the SNVS, leading to challenges in generating actionable information for sanitary surveillance.

RIA Report Proposes Regulatory Alternatives to Enhance SNVS Effectiveness

To address these challenges, the RIA Report proposes several regulatory alternatives to improve the overall effectiveness of the SNVS. The first alternative focuses on harmonizing and standardizing guidelines for organizing, coordinating, and decentralizing SNVS actions. This includes maintaining the parameters established in RDC 560/2021 and adopting the principles of subsidiarity to regulate local competencies not exclusively held by the Union, thereby promoting a more localized approach to sanitary surveillance actions.

The second alternative involves implementing an integrated information management system for SNVS. Options include maintaining existing information systems and data flows, implementing the updated National Information System in Visa (SINAVISA), and adopting and implementing the Minimum Data Set in Visa (CMD-VISA) to promote effective information management and timely decision-making based on evidence.

The third alternative aims to improve management and execution practices for sanitary surveillance actions. This includes maintaining the scope and guidelines established in RDC 560/2021 and harmonizing criteria for the execution of sanitary surveillance actions based on risk management and quality management guidelines, tailored to the health situation of each territory.

Surveillance

Anvisa Proposes Enhancing SNVS Operational Capacity and Implementation Guidelines

The fourth alternative seeks to enhance the operational capacity of SNVS. This includes maintaining current policies and models for SNVS operations, including professional training and financial resource distribution, and harmonizing criteria and requirements to support SNVS operations with a focus on efficiency, monitoring, and evaluation through established goals and indicators.

The development of the new guidelines involved extensive consultation and collaboration with representatives from sanitary authorities, coordinated by Anvisa’s Sanitary Surveillance Working Group. The proposal underwent Public Consultation 588/2018, as well as directed consultations with the National Sanitary Surveillance System (SNVS). To support the implementation of the revised guidelines, Anvisa will conduct training sessions and webinars with state and Federal District sanitary authorities. Additionally, a comprehensive manual will be published on Anvisa’s website to guide the adoption of the new system.

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The suggested regulatory alternatives aim to enhance the organization, coordination, and decentralization of SNVS actions, promoting regulatory convergence and ensuring legal security for the regulated sector. However, implementing these improvements may require increased costs and efforts for developing infrastructure and resources.

Anvisa’s Report Highlights Surveillance System Modernization: Benefits and Challenges

The positive impacts include enhanced effectiveness through improved organization and coordination of sanitary surveillance actions, regulatory convergence with harmonized guidelines and practices across different levels of government, increased access through faster and more efficient local implementation of sanitary surveillance actions, and evidence-based decision making with better data sharing and management. The negative impacts include increased costs for developing infrastructure and resources and operational challenges requiring additional efforts for training and capacity building among sanitary authorities.

Anvisa’s publication of the Regulatory Impact Analysis Report represents a significant step towards modernizing and improving the organization, coordination, and decentralization of Brazil’s sanitary surveillance system. By addressing key regulatory challenges and proposing well-considered alternatives, Anvisa aims to enhance public health safety and regulatory compliance. The new guidelines and systems will provide a more effective framework for sanitary surveillance, ensuring better health outcomes for the population and fostering trust and transparency in the regulatory process.

 

Resource: National Health Surveillance Agency, June 04, 2024

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