Keywords
healthcare
healthcare management
medicinal product circulation
pharmaceutical market
regulatory policy
preventive regulation
sustainable development
How to Cite
Abstract
This article focuses on refining the methodological foundations of preventive pharmaceutical market regulation within a strategic perspective extending to 2030, addressing the limitations of traditional reactive public governance models. The relevance stems from structural deficiencies in existing regulatory systems that were exposed during the global pharmaceutical crisis of 2020–2022, when conventional approaches proved incapable of translating expert forecasts regarding production monopolization risks into preventive actions. The aim is to substantiate the methodological foundations of preventive regulation by revealing the conceptual underpinnings of public governance role transformation and systematizing the principles and instruments of preventive regulation, while considering long-term pharmaceutical sector challenges. The methodological foundation comprises a comprehensive approach combining systems analysis, strategic planning, and comparative analysis. The theoretical framework is formed by concepts of risk-based regulation, proactive policy, and adaptive governance. The principal findings include conceptualizing preventive regulation as a new paradigm operating according to the logic “environmental monitoring → trend identification → risk forecasting → proactive formation of desired states → adaptive correction” instead of the traditional scheme “problem → diagnosis → intervention → control”. Five fundamental principles are systematized: anticipation, adaptability, systematicity, participation, and evidence-based approach. International experience in preventive regulation is analyzed, including the Dutch IMPACT platform, Canada’s “predictive safety” system, British adaptive regimes, and Singapore’s “regulatory ecosystem of the future”. The practical significance lies in developing the architectonics of preventive regulation as a methodology for designing regulatory systems capable of identifying and neutralizing potential threats at early stages of their formation.
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