REGULATION AND CLINICAL GOVERNANCE OF TECHNOLOGIES IN UNIVERSAL HEALTH SYSTEMS

Abstract

The incorporation of new medical technologies into universal health systems, such as Brazil’s Unified Health System (SUS) and the United Kingdom’s National Health Service (NHS), requires a systematic appraisal of scientific evidence, cost-effectiveness, and social impact. In Brazil, Law 12.401/2011 and the work of the National Commission for the Incorporation of Technologies in SUS (CONITEC) have established Health Technology Assessment (HTA) as a mandatory criterion for coverage decisions. In the UK, the National Institute for Health and Care Excellence (NICE) conducts Technology Appraisals based on quality-adjusted life years (QALYs) and cost-effectiveness thresholds deemed acceptable for public spending. In both settings, technical appraisal rests on evidence of efficacy, effectiveness, safety, and budget impact, while ethical analysis considers distributive justice, equity of access, and transparent decision-making. Recent studies suggest that new technologies—especially digital tools—can expand access and reduce disparities, but may also exacerbate inequities if implemented without adequate regulation or without addressing structural barriers to care. HTA seeks to answer key questions—whether a technology works, for whom, and at what benefit and cost, including opportunity costs—and, on this basis, to guide efficient allocation of scarce resources. This article examines the technical and ethical criteria that underpin HTA processes in universal systems, compares the experience of CONITEC and NICE, and highlights the role of primary care and family medicine in clinical governance and in translating national technology decisions into equitable care at the local level.