SERBIA Trends and Developments Contributed by: Bisera Andrijašević, BDK Advokati
Introduction The Serbian life sciences sector is currently character- ised not so much by major legislative reform, but by regulatory consolidation, institutional capacity-build- ing and increasing alignment with European Union (EU) standards. After a period marked by frequent amendments to secondary legislation and public pol- icy initiatives aimed at positioning Serbia as a regional biotechnology and digital health hub, the focus has shifted toward implementation, enforcement and gradual harmonisation with evolving EU frameworks. No comprehensive reform of the primary legislation on medicines has yet been adopted, even though the new medicines act has been discussed among stake- holders for several years. Meanwhile, important structural trends are shaping the market. These include growing pressure to improve patient access to innovative therapies, digitalisation of regulatory and healthcare systems, increasing scru- tiny by competition authorities, and the indirect but significant influence of ongoing EU pharmaceutical, health technology assessment (HTA) and digital health reforms. Serbia’s status as an EU candidate country means that legislative developments at EU level increasingly shape domestic expectations and future reform tra- jectories. As a result, even in the absence of sweeping domestic legislative change, the operating environ- ment for pharmaceutical, biotechnology and medical device companies continues to evolve. Market Overview and Access to Innovation The Serbian pharmaceutical market continues to expand steadily, with total annual market value exceeding EUR1 billion. Healthcare expenditure remains at approximately 10% of GDP, with public funding covering the majority of total health expendi- ture and a significant proportion still financed through out-of-pocket payments. Despite growth in overall spending, patient access to innovative therapies remains one of the central struc- tural challenges. Over the past several years, a num- ber of new innovative medicines have been included in the positive reimbursement list of the National Health Insurance Fund. However, a substantial number of
innovative products remain outside the reimburse- ment system, resulting in delayed access compared to EU member states. The dynamics of updating the positive reimbursement list continue to lack predictability, which represents one of the most important challenges for pharmaceu- tical companies. There is no fixed or clearly structured timeline for regular updates, and the decision-making process is often perceived as insufficiently transpar- ent. Although certain progress has been made in expanding access to additional indications of already reimbursed medicines, broader systemic reform of the reimbursement decision-making framework has not yet materialised. At the same time, pricing regulation remains based on external reference pricing, with Greece included alongside Italy and Slovenia as reference countries. This pricing model places downward pressure on medicine prices. While beneficial for public expendi- ture control, aggressive price referencing may reduce incentives for early market entry and contribute to supply vulnerabilities, particularly in a relatively small market such as Serbia. Going forward, improving predictability and transpar- ency in reimbursement decisions may be as important as increasing the volume of new inclusions. Investors and market participants increasingly prioritise regula- tory certainty and procedural clarity over formal leg- islative amendments. Regulatory Framework: Alignment Without Comprehensive Reform The core medicines legislation dates back to 2010, and although a new Medicines Act has been announced on several occasions, no draft has yet been published. As a result, the regulatory system continues to operate within an older legislative structure supplemented by numerous by-laws and regulatory practice develop- ments. Rather than broad legislative reform, recent develop- ments have centred on practical alignment with EU regulatory standards. The Medicines and Medical Devices Agency of Serbia (ALIMS) has increasingly taken into account decisions and scientific assess-
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