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Legal regulation of the EU pharmaceutical market and the possibility of implementing the European experience in Ukraine

Ruslan S. Fyl, Svitlana P. Fyl, Iryna V. Аlekseenko, Maryna P. Kobets, Iryna H. Lubenets


The study deals with the analysis of the EU legislation provisions in the field of pharmaceutical market regulation. The main focus is laid on the analysis of the provisions of the EU founding acts as well as of the secondary legislation. The features of the legal regulation of the EU pharmaceutical market are distinguished based on the analysis of Directive 2001/83 provisions, including for the purpose of implementing certain legal regulation mechanisms in the legislation of Ukraine. A special focus is made on the study of EU pricing instruments in the pharmaceutical sector. In particular, the mechanisms of regulating the price of pharmaceuticals by means of reverse payments are studied. The procedure for admission of pharmaceuticals to the EU market is addressed, and other mechanisms of non-price regulation of the pharmaceutical sector are explored. The necessity to implement the EU experience in the field of pharmaceutical market regulation into Ukrainian legislation has been proved, taking into account the interests of national manufacturers. The principles and the key foundations of combining the objectives are revealed for providing the EU citizens with high-quality and affordable medicines while protecting European pharmaceutical manufacturers and enhancing their competitive advantages through state regulation over the non-European manufacturers. Such findings demonstrate the need to integrate the abovementioned objectives in order to achieve the goal of ensuring the development of the Ukrainian pharmaceutical market‎.

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