Prepakiranje zdravil v Evropski uniji

Žerajić, Nataša (author), Podobnik, Klemen (mentor)

V Evropski uniji ima vsaka država članica pristojnost določati cene zdravil, ki se prodajajo na njenem teritoriju. Različni sistemi zdravstvega varstva in zavarovanja ter interesi držav članic vodijo do opaznih razlik v cenah zdravil med državami članicami. Razlike v cenah ustvarjajo poslovne priložnosti za vzporedne uvoznike, ki izkoriščajo prosti pretok blaga v EU in kupujejo zdravila v državah, kjer so cenejša ter jih uvažajo v države, kjer so zdravila dražja. Načelo prostega pretoka blaga in doktrina izčrpanja pravic omogočata vzporedni uvoz zdravil, ki so bili s strani ali s soglasjem imetnika pravice dani na trg v Evropski uniji. Vendar pa ima izčrpanje pravic intelektualne lastnine pomembne izjeme. Nacionalna pravila, pravila EU in preference potrošnikov zahtevajo, da so vzporedno uvožena zdravila ustrezno prepakirana in označena preden so dana na trg v državi članici uvoznici. V skladu z drugim odstavkom 15 .člena Direktive 2015/2436 lahko imetnik blagovne znamke, če obstajajo upravičeni razlogi, nasprotuje nadaljni prodaji blaga, še zlasti, če se je stanje spremenilo ali poškodovalo po tem ko je bilo dano na trg. Vendar dejanja imetnika blagovne znamke ne smejo prispevati k umetni delitvi trgov med državami članicami. Zato je Sodišče Evropske unije ustvarilo seznam pogojev (BMS pogoji), ki jih mora vzporedni uvoznik spoštovati pri prepakiranju vzporedno uvoženih zdravil. Sodišče mora pri odločanju v zadevah glede prepakiranja zdravil vzpostaviti ravnovesje med načelom prostega pretoka blaga, ki je eden od temeljev notranjega trga EU ter zaščito pravic iz blagovne znamke. Namen tega magistrskega diplomskega dela je analizirati seznam pogojev, določenih s strani Sodišča Evropske unije (BMS pogoji), ki jih morajo vzporedni uvozniki upoštevati pri prepakiranju in ponovnem označevanju vzporedno uvoženih zdravil.

• Language: Slovenian
• Keywords: vzporedni uvoz, paralelni uvoz, zdravila, farmacevtski proizvodi, intelektualna lastnina, znamka, izčrpanje pravic prost pretok blaga, BMS pogoji, Direktiva 2015/2436
• Work type: Master's thesis/paper
• Organization: PF - Faculty of Law
• Year: 2017
• PID: 20.500.12556/RUL-95415
• COBISS.SI-ID: 15786321
• Publication date in RUL: 20.09.2017

ŽERAJIĆ, Nataša, 2017, Prepakiranje zdravil v Evropski uniji [online]. Master’s thesis. [Accessed 14 August 2025]. Retrieved from: https://repozitorij.uni-lj.si/IzpisGradiva.php?lang=eng&id=95415

Secondary language

• Language: English
• Title: Repackaging of Pharmaceuticals in European Union

Abstract

In the European Union, each member state has an exclusive right to define its health care policy, including prices of the drugs sold in its territory. This leads to significant differences in the prices of pharmaceuticals across the EU and creates business opportunities for parallel importers who can buy drugs in those countries where they are cheaper and import them to the more expensive ones. In the European Union, so long as a pharmaceutical manufacturer has placed a good on the market voluntarily, the principle of free movement of goods and doctrine of exhaustion allows parallel importers to trade goods across borders without the consent of the producer. However, exhaustion of intellectual property rights in the European Union has important limitations. National and EU disclosure regulations, packaging requirements, language rules, and consumer preferences may require that pharmaceuticals are properly repackaged and relabelled before being placed on the new market of a importing member state. According to Article 15(2) of Directive 2015/2436 the trade mark proprietor is allowed, if legitimate reasons exist, to oppose further commercialisation of the goods, especially where the condition of the goods is changed or impaired after they have been put on the market. However, proprietor’s opposition to repackaging cannot contribute to an artificial partitioning of the markets between Member States. Therefore European Court of Justice set out list of conditions (the BMS conditions) to be respected by the parallel importer when repackaging an imported pharmaceutical product. When deciding on repackaging cases the ECJ has to strike a balance between the principle of free movement of goods and the protection of trademark rights. The purpose of this master thesis is to analyse list of conditions, set out by European Court of Justice (the BMS conditions), to be respected by the parallel importer when repackaging an imported pharmaceutical product.

• Keywords: European Union law, Parallel Imports, Grey Markets, Free movement of goods Pharmaceuticals, Intellectual Property, Trade marks, Trade Marks Directive, Doctrine of exhaustion, BMS conditions, Repackaging