Agnieszka Zimmermann, Piotr Malach
Import równoległy produktów leczniczych
2009-09-15
Parallel import of medicinal products. The Polish pharmaceutical market may comprise medicinal products that are subject to parallel import. Such form of importing medicinal drugs consists in importing medicinal products whose price is competitive in relation to the domestic price from the European Union member states or the member states of the European Free Trade Association. The products imported have to meet the circumstances stipulated by pharmaceutical law. Raising numerous controversies on the level of legal speculations, parallel import - related topics are often subject to decisions by the European Court of Justice. The Court of Justice decisions being at the same time binding to Polish common courts of law. This article attempts to introduce the essence of parallel import, its origins as well as the benefits for patients it may yield along with the disadvantages it may bring for the pharmaceutical market. However, the issues of parallel import, whose legality has become unquestionable, have not still been regulated by any binding Community act. The issues in question are dealt with by the numerous European Court of Justice decisions as well as by soft law regulations.Keywords: medicinal product, legislation, soft law, drug market, parallel distribution.