SERBIA Trends and Developments Contributed by: Bisera Andrijašević, BDK Advokati
Data protection, cybersecurity and interoperability will therefore become increasingly important regulatory topics in the life sciences sector. Growing Influence of EU Health Technology Assessment Reform One of the most significant EU-level developments with potential long-term impact on Serbia is the application of Regulation (EU) 2021/2282 on Health Technology Assessment, which became applicable in January 2025. The Regulation introduces joint clini- cal assessments for certain medicinal products at EU level and aims to harmonise aspects of clinical evalu- ation across member states. Although Serbia does not currently operate a fully institutionalised HTA system comparable to many EU countries, the EU’s move toward structured joint assessments may influence domestic expectations regarding transparency, evidence requirements and methodological standards in reimbursement decision- making. As Serbia continues to align its healthcare framework with EU practices, greater formalisation of HTA pro- cesses may become inevitable. Enhanced transpar- ency, clearly defined evaluation criteria and structured stakeholder involvement could significantly improve the predictability of market access decisions. Clinical Trials: Stabilisation After Regulatory Turbulence Following a period of regulatory volatility in the clinical trials framework, the current regime allows both public and private healthcare institutions to conduct phase I, II and III clinical trials, subject to compliance with applicable regulatory and ethical standards. Import authorisation for investigational medicinal products is granted simultaneously with clinical trial approval, reducing administrative burden and improving proce- dural efficiency. The stabilisation of the clinical trials framework has improved Serbia’s competitiveness as a destination for early-phase clinical research. Serbia offers several structural advantages, including experienced investi- gators, cost-effectiveness and relatively rapid patient recruitment. However, continued improvements in
administrative efficiency and predictable timelines remain essential for maintaining attractiveness com- pared to neighbouring jurisdictions. At EU level, the Clinical Trials Regulation (EU) No 536/2014 and the Clinical Trials Information System (CTIS) have introduced a harmonised and centralised framework for trial approvals within the EU. Although Serbia is not part of the EU system, the harmonised EU environment increases competitive pressure. Sponsors increasingly expect streamlined, transpar- ent and predictable approval procedures aligned with EU standards. Increased Scrutiny by the Serbian Competition Authority A notable trend in the life sciences sector is the increased activity and scrutiny of the Serbian Com- mission for Protection of Competition. The pharma- ceutical sector has attracted particular attention due to its structural characteristics, including high levels of regulation, public procurement dominance and verti- cal distribution arrangements. The Authority has adopted a stricter approach to indi- vidual exemptions for exclusive distribution agree- ments in the pharmaceutical sector, particularly in cases involving products procured through public tenders organised by the Health Insurance Fund. By defining relevant markets at the level of individual mol- ecules and identifying 100% market shares in certain cases, the Authority has significantly narrowed the scope for exclusive arrangements where inter-brand competition is limited. In addition, the launch of a sector inquiry in January 2025 into pharmaceutical market signals heightened regulatory interest in pricing structures, vertical rela- tionships between wholesalers and pharmacy chains, and potential barriers to entry. Sector inquiries often precede infringement proceedings or policy recom- mendations. As a result, pharmaceutical companies and distributors should expect a more interventionist approach by the competition authority in the coming years.
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