Introduction (relevance). The incidence of malignant neoplasms, including breast cancer (BC), shows a stable upward trend. Breast cancer ranks second among oncological pathologies in women, accounting for 11–13% of all cases. Despite successes in developing targeted and immunotherapeutic drugs that increase survival and quality of life, their availability remains a subject of intense debate. The regulatory and legal framework for subsidized drug provision faces several challenges: funding deficits, imperfections in the formulation of the Essential Drugs List (EDL), and legal conflicts at the regional level. Purpose: To analyze the regulatory framework of drug provision for cancer patients and identify legal gaps that prevent high-quality and timely treatment of patients with breast cancer (BC). Materials and methods. The research methodology involves a comprehensive analysis integrating systemic, comparative-legal, formal-legal methods, and document content analysis. The information base comprises ten regulatory legal acts of the Russian Federation in the fields of healthcare and pharmaceutical provision, effective as of 2026. The practical dimension and systemic legal conflicts were examined through a content analysis of seven judicial decisions retrieved from the 'Pravosudie' State Automated System and 'SudAkt' databases spanning the period from 2023 to 2026. Results. Analysis of state drug coverage programs identifies key funding sources (CMI, federal/regional budgets) and the critical role of the Essential Drugs List (EDL). A proposed classification of access barriers links legal disputes to gaps in fulfilling state guarantees, highlighting the need for administrative reform, digitalized tracking, and flexible funding to improve access to modern therapies. Discussion. In the course of the study, a classification of barriers preventing the realization of citizens' rights to receive innovative targeted therapy was developed. Three main groups of barriers were identified. Among the administrative and legal barriers, the imperfection of decision-making procedures and the bureaucratization of the subsidized drug provision (SDP) process were noted. This mostly affected the conflict between the Essential Drugs Lists (EDL) and patient routing in terms of the lack of a therapeutic continuity mechanism for patients treated in federal centers when they are transferred to regional medical organizations (MO). Budgetary and financial barriers are caused by the deficit of territorial programs and the specifics of budget planning. Informational and legal barriers were associated with the insufficiency of up-to-date data and the imperfection of accounting systems. At the same time, eliminating only one of these barriers will not lead to a significant improvement in the situation for patients, which emphasizes the need for a comprehensive approach to system reform. Conclusions (conclusion). Despite expanded Essential Drugs Lists (EDL) and mandatory clinical guidelines, legal mechanisms for breast cancer drug provision in the Russian Federation remain flawed. The disparity between federal standards and regional financing creates "drug inequality," necessitating a mandatory automatic federal subsidy system for expensive, commission-approved therapies.