Citation

Pashkov V, Soloviov A, Olefir A. Wiad. Lek. 2017; 70(4): 843-849.

Affiliation

Department Of Civil, Economical And Environmental Law Poltava's Institute Of Law Yaroslav Mudryi National Law University, Poltava, Ukraine.

Copyright

(Copyright © 2017, Polskie Towarzystwo Laekarskie)

DOI

unavailable

PMID

29064815

Abstract

INTRODUCTION: The paper identifies key risks associated with the illegal production and sale of medicines. Also there were generalized features of criminal responsibility for acts related to the trafficking of drugs in some Member States of the EU and analyzed legal means of combating the falsified drugs today. The problem concerning falsification of medicines is particularly acute not only in developing countries but also in developed ones. Fake is one in ten - twenty drug. The largest share of falsified drugs comes from the so-called "Asian tigers", already from which they come to the EU market. THE AIM: In this publication authors have set following objectives: - to determine the risks associated with illegal production and sale of medicines; - organize legal means of combating the falsified medicines in the EU member states; - clarify features of criminal responsibility for acts related to the trafficking of drugs in the EU countries.

MATERIALS AND METHODS: The article bases on the works of scholars and experts, statistical information and other sources. Particular attention is paid to the analysis of regulations of the EU institutions and national criminal laws. So, provisions of the criminal codes of 10 EU member states were taken into account.

RESULTS: There is a system of legal measures which counter the circulation of falsified medicines in the EU and consists of general and specific regulatory requirements, mainly of economic and legal nature. The most important role among the last play package labeling requirements for drugs and license conditions.

DISCUSSION: In the article were discussed factors that stimulate the production and sale of falsified drugs and the risks associated with these. Demarcated the concept of "falsified medicinal product", "counterfeit drug", "substandard drug".

CONCLUSIONS: Although there are guidelines for patients to identify falsified drugs, still a major role in this process should play public authorities and enterprises. In all the countries illegal circulation of falsified drugs is prohibited under threat of criminal or administrative responsibility.

Language: en

Keywords

Directive 2001/83/EC; Regulation (EU) 2016/161; counterfeit; criminal responsibility; falsified drugs; substandard drugs; the unique identifier