Integration of Ukraine into Regional Pharmaceutical Supply Chains: Regulatory Challenges, Social Dimensions, and the Innovative FIRM Framework

Abstract

Purpose. The purpose of the study is to provide a comprehensive analysis of the regulatory, institutional, and socioeconomic environment of Ukraine’s pharmaceutical supply system under conditions of full-scale war, to assess its readiness for integration into regional and European pharmaceutical supply chains, and to substantiate the innovative analytical FIRM framework (Financial – Institutional – Regulatory – Medical-social) as a tool for quantitative and qualitative evaluation of system resilience, adaptability, and social equity in access to medicines for vulnerable population groups. Special attention is paid to the role of public policy, digital solutions, and cross-sectoral cooperation in ensuring the continuity of pharmaceutical supply under military and humanitarian crises. Materials and methods. The study is based on the analysis of Ukrainian legal and regulatory acts, strategic and program documents of the Ministry of Health and the National Health Service of Ukraine, analytical reports of the WHO, the European Commission, and the European Medicines Agency, as well as scientific publications from 2018–2024 and statistical data on the structure of pharmaceutical imports, public procurement, and reimbursement programs. Comparative analysis was applied to examine pharmaceutical supply models in Poland, Slovakia, and Austria. The FIRM framework was used for an integrated assessment of financial sustainability, institutional trust, regulatory alignment, and medical-social accessibility. Scenario analysis was employed to forecast possible development trajectories of the pharmaceutical supply system under wartime and post-war transformations. In addition, elements of systems and institutional analysis were used to identify barriers to inter-agency coordination and to assess the role of social workers in medicine logistics and patient support. Results. It was found that Ukraine’s pharmaceutical supply system is characterized by high dependence on imports, fragmented inter-agency coordination, and significant regional disparities in access to medicines, particularly among older persons, internally displaced populations, patients with cardiovascular and chronic diseases, and residents of frontline territories. At the same time, positive developments were identified in the areas of reimbursement, digitalization (e-prescriptions, electronic registries, medicine traceability systems), simplification of import procedures, and gradual harmonization of national legislation with EU standards. Application of the FIRM framework demonstrated that in 2023–2024 the average integrated level of Ukraine’s readiness for pharmaceutical integration ranged from 2.6 to 3.2 points out of 5, indicating partial compliance with European benchmarks and the presence of systemic gaps. The most critical weaknesses were observed in financial sustainability (instability of funding, dependence on donor programs) and medical-social access (limited coverage of vulnerable groups, insufficient social support), whereas regulatory adaptation and digital infrastructure showed moderate but steady progress. Comparative analysis with Central European countries confirmed that the combination of digital tools, a multidisciplinary approach, and the active involvement of social workers in healthcare systems enhances the resilience of pharmaceutical supply chains and reduces inequalities in access to treatment. Conclusions. Integration of Ukraine into regional and European pharmaceutical supply chains should be regarded not only as a technical, economic, and regulatory process, but also as a social and ethical challenge aimed at ensuring equitable and uninterrupted access to medicines under crisis conditions. The proposed FIRM framework represents a relevant instrument for the systematic evaluation of public policy effectiveness, identification of reform priorities, and development of post-war recovery strategies for the pharmaceutical sector and Ukraine’s integration into the European pharmaceutical area. Its application enables the integration of financial, regulatory, institutional, and social dimensions into a single analytical model, thereby contributing to increased resilience of the healthcare system, strengthened institutional trust, and reduced inequalities in access to medicines for vulnerable population groups. Furthermore, the findings highlight the need to strengthen regional-level pharmaceutical supply governance through the establishment of pharmacy-logistics hubs, the development of digital stock-monitoring platforms, and the integration of social services into medicine distribution processes. Special importance is attached to the training of specialists in clinical social work and health management capable of operating under conditions of uncertainty, crises, and humanitarian challenges. Implementation of the proposed approaches will enhance the overall resilience of the healthcare system, reinforce public trust in institutions, and lay the groundwork for Ukraine’s full-fledged integration into the European pharmaceutical space.