VIGILÂNCIA SANITÁRIA E O PRINCÍPIO DA JUSTIFICAÇÃO AMPLIADA:

a Visa como indutora de crescimento socioeconômico e desenvolvimento sustentável

Abstract

This article proposes an evolution in the paradigm of Sanitary Surveillance (Vigilância Sanitária - Visa) in Brazil, traditionally focused on risk management. It argues that the classical approach is insufficient for contemporary complexities, introducing the concepts of Expanded Sanitary Justification (JSA) and Expanded Sanitary Benefit (BSA). The central thesis is that Visa's regulatory process must transcend direct health risk-benefit analysis, explicitly integrating socioeconomic and environmental gains and losses beyond the exposed individual.

This expanded perspective is inspired by the principle of justification in radiological protection, as defined by the International Atomic Energy Agency (IAEA) and the International Commission on Radiological Protection (ICRP). This principle mandates that the detriments of an activity must be outweighed by the expected individual and societal benefits, taking into account economic, social, and environmental factors.

The literature review explores the evolution of risk and benefit concepts in public health, highlighting Navarro's (2007) "potential risk" and Freitas, Leandro, and Navarro's (2019) "potential benefit," advocating for symmetry in their evaluation. The text elaborates on the justification principle in radiological protection, emphasizing its holistic nature and the need to weigh economic (energy generation, industrial development), social (access to medical services, quality of life), and environmental factors. It also connects regulatory governance with Sustainable Development Goals (SDGs), demonstrating how effective regulation can foster innovation and growth.

The concept of Expanded Sanitary Benefit (BSA) is defined as the total aggregate value that the existence, availability, and access to a Visa-regulated product, process, or service confer to society, encompassing economic (job creation, taxation, innovation), social (access to health goods/services, reduction of inequalities, public trust), and environmental (more sustainable practices, clean technologies) contributions.

The Expanded Sanitary Justification (JSA) Model implies that a regulatory decision is only justified if it produces a "net positive benefit," where the total set of benefits (direct and indirect health, economic, social, environmental) outweighs the total set of detriments (direct and indirect health, economic, social, environmental). Practical examples, such as the decision regarding the interdiction of a unique hemodynamics service in a region, artisanal sour cassava starch production, and the approval of medicines with national production capacity, illustrate how JSA can lead to more balanced decisions that promote sustainable development.

Implementing JSA and BSA requires significant transformations in regulatory governance, including the need for new tools and metrics (fiscal impact analyses, socioeconomic indicators, Life Cycle Assessments, multi-criteria evaluation models), multidisciplinary team training, and intersectoral collaboration. Additionally, ethical and transparency challenges are raised to ensure that sanitary safety is not compromised and Visa's legitimacy is maintained, alongside the necessity for legislative adjustments to formally include these factors in regulatory decisions.

In conclusion, the study positions Visa as a strategic actor in promoting sustainable development, balancing health protection with the creation of economic, social, and environmental value, without compromising essential sanitary safety standards.