A medicine as an object of civil rights: A concept, attributes and comparison to the foreign approach

Abstract

The article addresses the issue of classifying a limited civil circulation thing as a medicine that is defined by a set of attributes including generic ones. After the adoption of the first specialized law — Federal law “On Medicines” N 86-FZ dated 22.06.1998 legal standards for different law branches where medicine is a law object have been formulated. This explains the relevance of this research and its practical applicability in further development of legislative initiatives and regulatory practices. The correctness of medicine definition in the Russian legislation can be determined by the comparison of laws of the leading countries on the international pharmaceutical market — USA, Japan and Germany. Providing a certain degree of succession from German legislation, the term medicine and its attributes as they are defined in the Federal law “On Circulation of Medicines” № 61-FZ dated 12.04.2010 and used herein, in general demonstrate the same approach as in the countries mentioned above, which allows to conclude that the Russian legislation has been developing not independently but rather in the context of previous and ongoing studies of Russian researches and scholars from Anglo-American and Romano-Germanic legal systems. The article addresses controversial issues of drug circulation and challenging practical aspects, namely distinguishing medicines from related by application chemical substances, biologically active additives, medical devices and perfume and beauty products.