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European-law aspects of parallel trade
Naatz, Alena
1. Parallel trade in general Parallel trade is characterized by the export of a product from a country where it is purchased for a lower price and its sale in a market where it is sold for a higher price, in competition with the same kind of product in the import market. This manner of trade assumes that the product is placed on the export and import markets by the producer or with the producer's consent. The product need not be protected with intellectual-property rights in order for this to involve parallel trade. Despite this, in most cases parallel-traded goods will be protected with a patent, registered trademark or copyright.1 This is particularly because connecting a product with intellectual rights provides the producer with an economic monopoly, which is reflected in the generally higher price of the product on the market and the common price differences between individual markets. Parallel, or concurrent, trade is also called arbitrage. A parallel importer uses the difference in the price of a product in the export and import markets2 . The price of a parallel- imported good in the country of import will logically be higher than the price in the export market, though at the same time it will be lower than the price of the same product in the import market. Parallel import creates pressure on the...
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Free Movement of Medical Devices
Moravová, Veronika ; Šmejkal, Václav (advisor) ; Svoboda, Pavel (referee)
1 Abstract This thesis deals with the conflict between the interest in the free movement of medical devices and the interest in the protection of health and safety. It is divided into two main parts, with the first part focusing on the pre-market phase, i.e. the phase before a medical device is placed on the market. The first part consists of two chapters describing the historical development of the regulation of medical devices and its separation from the regulation of medicinal products, as well as the way in which medical devices enter the market and what they must fulfil in order to be freely traded across the Member States. In particular, this part addresses the question of whether this separation (i.e. the move away from the 'old approach' to the 'new approach') was a step in the right direction or a 'historical mistake'. The system of CE certification of medical devices based on the participation of external auditors - Notified Bodies - is thoroughly discussed. The second part of the paper is devoted to the post-market phase (after the medical device has been placed on the market). The focus is on two 'knot problems', i.e. areas where the interest in free movement and the interest in protecting health and safety collide in practice, namely border products and parallel trade (specifically issues...
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EU Competition Law and Practices Hindering Market Entry of Drugs
Křešová, Karolína ; Šmejkal, Václav (advisor) ; Svobodová, Magdaléna (referee)
EU Competition Law and Practices Hindering Market Entry of Drugs This thesis deals with the legality of pharmaceutical companies' practices that hinder market entry of drugs, whether within the intra-brand or inter-brand competition, from the EU competition law perspective. The aim of this thesis is to introduce the reader to the issue of different practices aimed at limiting parallel trade and also at delaying or complete prevention of the market entry of a new competing drug, and also to assess whether the competition authorities have established clear guidance on the performance of these practices, i.e. whether they are clearly set boundaries between acceptable restriction of competition which can be justified and distortion which cannot be allowed. For the purpose of this assessment, the relevant decisions of the European Commission and the CJEU are analyzed, identifying the key factors on which the competition authorities place emphasis when assessing the compliance of such practices with the EU competition law, and general conclusions are drawn from these key factors to determine whether there is a sufficient degree of legal certainty for pharmaceutical companies engaging in these practices. The thesis is divided into six chapters, of which chapters three, four and five form the main part....
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Legal aspects of a parallel trade in drugs within the EU
Bečvářová, Tereza ; Šustek, Petr (advisor) ; Salač, Josef (referee)
5.Abstract Title: Legal aspects of a parallel trade in drugs within the EU Key words: single market, parallel trade, price regulation, pharmaceuticals Parallel trade is one of the most distinctive benefits of the European single market. In a simplified way, parallel trade is legal importing of drug from one country where it is legally marketed into a second country where the marketing authorization holder also markets that product, but without the consent of the marketing authorization holder. Price regulation of medical products makes parallel trade of drugs questionable. Final price for customer is not result of an independent decision of pharmaceutical company but it is given by relevant authority often regarding the spending power of citizens. Wholesalers are taking advantage of these price differences when they are buying cheap drugs in low-price countries and selling them with profit in countries where drug price are higher. In theory this practice should deliver significant saving for patient and national healthcare insurance system in destination countries due to lower price of parallel traded drugs. However many studies show minimum impact on drug price in these countries since wholesalers retain great part of the financial benefits. On the other hand, negatives of parallel trade are evident. Drug...
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Business plan – Pharmaceutical Parallel Trade
Šašek, Otakar ; Tyll, Ladislav (advisor) ; Strouhal, Jiří (referee)
Master thesis is primarily focused on parallel trade with medicinal drugs within European Union. In regard to attractive offer for cooperation with strong supplier of mentioned goods was required to valorise realization possibility and potential of idea. Business plan estimates different variants or realization and progress, describes it in numbers and wide context. Object of thesis is absolutely real case of starting intermediary company in pharmaceutical field specifically in parallel "reexport" of pharmaceutical drugs and accessories between states of European Economic Area. In first two passages study remembers methodology of business plan and passes to bases of legislative frame related with. Subsequently are described market movements, thoroughly analysed its weak points and also strengths and opportunities. Everything is simultaneously reflected with object of our business plan to support reality of whole master thesis. After short marketing passage comes the largest part dealing with financial calculations. Considered are three variants of potential reality and in each of them are calculated costs, revenues, profit and cash flow for single months and whole year. Conclusion summarizes and evaluate project as whole. Considering infestation of input costs against its rentability and potential other opportunities of the pharmaceutical market. Evolution of European market mostly depends on legislation regulations of EU and single countries.
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