In the beginning of January, the Commission for Protection of Competition (CPC) announced the launch of a sectoral analysis aimed at evaluating the state and conditions of competition within Serbia’s pharmaceutical market. The focus of the investigation will be on medicines for human use, specifically those on the list of drugs prescribed and dispensed through mandatory health insurance.
As part of the analysis, the CPC has begun distributing questionnaires to pharmacies with multiple retail outlets to gather critical data. The information collected will form the foundation for a comprehensive review of the market's competitive dynamics.
As announced, several key factors of the pharmaceutical market will be examined, with the primary focus on drug pricing, market shares, competitive conditions, and any potential barriers to market entry. Furthermore, the CPC will evaluate the vertical relationships between wholesalers and pharmacies, which could impact the competitiveness of the market conditions and pricing transparency.
Practical Consequences and Future Actions
The sectoral analysis is expected to have significant implications for the pharmaceutical market in Serbia.
The goal of the sectoral analysis is to foster an environment where competition thrives, leading to improved access to medicines and potentially lower prices for consumers. As part of the official report, the CPC also plans to issue recommendations on how the identified issues could be addressed, which would contribute to a more competitive and efficient pharmaceutical market. These would be general guidelines formulated based on the results of the conducted analysis. The guidelines will be dependent on the findings, but are expected to include proposals for regulatory changes, such as adjustments to pricing mechanisms, transparency in drug distribution, or measures to facilitate the entry of new market participants.
Aside from the general recommendations, the subjects jeopardizing fair market competition could face individual measures of the CPC for restoration of market balance. Namely, if the findings corroborate the existence of anticompetitive practices or barriers to competition, the CPC could proceed with issuing specific measures against entities found in breach of the provisions of the Law on Protection of Competition. The measures at CPC’s disposal vary and can include, among others, issuing fines or requiring structural changes in the market to ensure fairer competition and better access to more affordable medicines for consumers. Structural changes may require dissolving market participants, by means of selling shares or parts or assets of business entities to unrelated parties, or other means of protection of competition, depending on the type of violation that has been determined.
The report on the conducted sectoral analysis will be made available to both the general public and relevant authorities, industry participants, and other stakeholders (healthcare providers and insurers etc.) in the form of an official report, presumably by the end of 2025. In the coming months, it is expected that the CPC will continue to monitor the market and engage with all relevant parties to ensure that the recommendations, once issued, are effectively implemented.
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Koraci ka konkurentnom farmaceutskom tržištu u Srbiji?
Početkom januara, Komisija za zaštitu konkurencije (KZK) najavila je pokretanje sektorske analize s ciljem ocene stanja i uslova konkurencije na farmaceutskom tržištu Srbije. Fokus analize biće na lekovima za humanu upotrebu, posebno onima koji se nalaze na listi lekova koji se propisuju i izdaju kroz obavezno zdravstveno osiguranje.
U okviru analize, KZK je počela da šalje upitnike apotekama, koje u svojoj mreži imaju više maloprodajnih objekata, kako bi prikupila ključne podatke. Prikupljene informacije poslužiće kao osnova za sveobuhvatnu analizu konkurentnosti učesnika na tržištu.
Kako je najavljeno, biće analizirano nekoliko ključnih faktora farmaceutskog tržišta, pri čemu će primarni fokus biti na cenama lekova, tržišnim udelima, uslovima konkurencije i potencijalnim barijerama za ulazak na tržište. Takođe, KZK će procenjivati vertikalne odnose između veleprodaja i apoteka, koji mogu uticati na konkurentnost tržišnih uslova i transparentnost cena.
Praktične posledice i dalji koraci
Očekuje se da će sektorska analiza biti od značajnog uticaja na farmaceutsko tržište u Srbiji.
Cilj sektorske analize je da se stvori podsticajno okruženje za tržišnu konkurenciju, što će posledično dovesti do veće pristupačnosti lekova i potencijalno nižih cena za potrošače. Kao deo zvaničnog izveštaja, KZK takođe planira da izda preporuke o tome kako se identifikovani problemi mogu rešiti, a što bi doprinelo konkurentnijem i efikasnijem farmaceutskom tržištu. Ove preporuke će biti u vidu opštih smernica formulisanih na osnovu rezultata sprovedene analize. Smernice će zavisiti od nalaza analize, ali se očekuje da će uključivati predloge za regulatorne promene, kao što su izmene mehanizama određivanja cena, transparentnost u distribuciji lekova, ili mere za olakšavanje ulaska novih učesnika na tržište.
Pored ovih opštih preporuka, subjekti koji narušavaju fer tržišnu konkurenciju mogli bi se suočiti sa pojedinačnim merama KZK koje bi za cilj imale povraćaj tržišne ravnoteže. Naime, ako nalazi potvrde postojanje praksi koje narušavaju ili sprečavaju konkurenciju, KZK bi mogla preduzeti pojedinačne mere protiv subjekata koji svojim postupanjem krše odredbe Zakona o zaštiti konkurencije. Mere koje KZK ima na raspolaganju se razlikuju, i mogu uključivati, između ostalog, izricanje novčanih kazni ili iniciranje strukturnih promena na tržištu kako bi se osigurala fer konkurencija i bolji pristup i povoljniji lekovi za potrošače. Pomenute strukturne promene mogu uključivati mere dekoncecntracije, poput podele privrednih društava, otuđenja akcija ili udela nepovezanim licima, kao i druge mere zaštite konkurencije, zavisno od vrste utvrđene povrede.
Izveštaj o sprovedenoj sektorskoj analizi stanja konkurencije na ovom tržištu biće dostupan široj javnosti, nadležnim organima, učesnicima industrije i drugim zainteresovanim stranama (pružaocima zdravstvenih usluga, osiguravajućim društvima itd.) u obliku zvaničnog izveštaja, najverovatnije do kraja 2025. godine. U narednim mesecima možemo očekivati da KZK nastavi sa praćenjem tržišta i komunikacijom sa svim relevantnim učesnicima kako bi osigurala da se preporuke, kada budu objavljene, efikasno i sprovedu.
Author: Nada Bakrač, Associate at IVVK Lawyers
For more information please contact us at office@lexquire-ivvk.rs
23/01/2025
