SERBIA Trends and Developments Contributed by: Bisera Andrijašević, BDK Advokati
This shift reflects a broader trend from legislative reform toward enforcement and market supervision as primary tools of regulatory oversight. Supply Chain Resilience and Shortage Prevention Medicine shortages have become a central policy concern across Europe. At EU level, initiatives such as the Critical Medicines Alliance and expanded short- age monitoring mechanisms aim to strengthen supply chain resilience and reduce strategic vulnerabilities. Serbia remains heavily dependent on imported medi- cines and active pharmaceutical ingredients. The external reference pricing system, combined with a relatively small market size, may reduce commercial incentives to prioritise supply in certain circumstanc- es. Over the past year, the National Health Insurance Fund introduced price revisions for a number of gener- ic medicines. This development marks a significant move toward enhancing the long-term sustainability of the pharmaceutical market and preserving patient access to essential treatments. The adjustment is widely viewed as a constructive step, as previously depressed price levels had placed considerable strain on manufacturers, creating a tangible risk of market withdrawals and supply shortages. By recalibrating prices, the authorities have contributed to improving supply stability and reducing disruption risks. Although Serbia does not yet operate a compre- hensive shortage monitoring system comparable to EU mechanisms, supply continuity has become an increasingly visible issue. Aligning with EU shortage prevention strategies and strengthening domestic monitoring capacities may become an important pol- icy priority in the coming years. Artificial Intelligence and Biotechnology Ambitions Serbia continues to position itself as a regional hub for biotechnology and artificial intelligence in health- care. The establishment of the Centre for the Fourth Industrial Revolution and ongoing development of the BIO4 Campus in Belgrade reflect strong political com- mitment to innovation-driven growth. However, regulatory frameworks for advanced thera- pies, gene and cell treatments and AI-driven medi-
cal systems remain underdeveloped. The EU Artificial Intelligence Act, which entered into force in 2024 and introduces a risk-based framework for high-risk AI systems, including certain healthcare applications, is likely to shape future Serbian regulatory develop- ments. To support its strategic ambitions, Serbia will need to ensure regulatory clarity in areas such as algorithm validation, clinical evidence requirements, data gov- ernance and liability frameworks for AI-assisted medi- cal decision-making. Outlook: Regulatory Predictability as an Imperative for the Future The Serbian life sciences sector has entered a period defined less by sweeping legislative reform and more by gradual institutional strengthening, enforcement activity and increasing EU influence. However, the key challenges remain: • adopting new primary medicines legislation; • improving predictability and transparency in reim- bursement decisions; • addressing administrative backlogs and ensuring compliance with statutory timelines; • strengthening supply chain resilience; • formalising health technology assessment pro- cesses; • fully implementing digital health infrastructure in practice; and • preparing for future alignment with major EU regu- latory reforms. For market participants, regulatory predictability, pro- cedural efficiency and alignment with EU standards will remain central considerations. Serbia’s future competitiveness in the life scienc- es sector will depend not only on formal legislative amendments but also on its ability to provide a sta- ble, transparent and efficiently administered regula- tory environment that supports innovation while safe- guarding public health and market competition.
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