SERBIA Trends and Developments Contributed by: Bisera Andrijašević, BDK Advokati
applications within the legally prescribed time- frames. Shortcomings in the Inclusion of Medicines on the Reimbursement List The current provisions governing the inclu- sion and removal of medicines from the posi- tive reimbursement list of the National Health Insurance Fund lack clear and detailed criteria, creating uncertainty in the selection process for medicines covered by mandatory health insur- ance. While some progress has been made, the decision-making process remains opaque. Each application for reimbursement should be sub- ject to greater transparency, with a mandatory explanation of the final decision and the right to appeal. The process and dynamics of updating the posi- tive list is inconsistent. The absence of a pre- dictable and structured update process creates challenges for business planning, disrupts the stability of medicine supply, and limits patient access to essential therapies. To address these issues, the legislative amendments should establish clear timelines and procedures for regular updates of the positive list. In 2023, the by-law on criteria for forming prices for prescription medicines was updated to intro- duce Greece as a reference country for pricing, alongside Italy and Slovenia, which is expected to reduce prices of medicines. Increased Scrutiny by the Serbian Competition Authority Increased scrutiny of exclusive distribution arrangements The Serbian Competition Authority has tightened its review of agreements submitted for individual exemption in the pharmaceutical sector. In July 2024, the Commission issued a decision reject-
ing a request to extend a previously granted individual exemption of an exclusive distribu- tion agreement between a major pharmaceu- tical company and its Serbian distributor. This marks the second time that the Commission has denied an individual exemption request, having previously refused to extend another exclusive distribution agreement in 2023. This signals a stricter stance by the Commission in this area. The medicines in question were used exclusively in inpatient healthcare institutions and procured through public tenders organised by the Repub- lic Health Insurance Fund. In its relevant market analysis, the Commission determined that each medicinal product cov- ered by the agreement constituted a distinct relevant market, as the product markets had to be defined at the level of individual molecules. Consequently, the manufacturer held a 100% market share for each product. Given that these medicines were procured solely through public tenders, with no inter-brand competition in the relevant markets, the Commission found that the only potential competition was intra-brand, through multiple suppliers of the same medicine. The exclusive distribution arrangement, if con- cluded, would eliminate or at the very least sig- nificantly restrict this form of competition. Sector inquiry into pharmaceutical sector Most recently, on 10 January 2025, the Commis- sion announced that it had launched a sectoral inquiry into the pharmaceutical market for medi- cines for human use in Serbia. The focus of the inquiry is on prescription medicines financed by the Serbian Health Insurance Fund, with a par- ticular emphasis on how the prices of medicines are determined at the retail level. The Commis- sion aims to assess the competitive conditions in the market, including market shares, vertical relations between wholesalers and pharmacies,
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