Content analysis of the official documents on the turnover of counterfeit medicines in Ukraine in 2017–2020

Abstract

The purpose of the work was to conduct a content analysis of the orders of the State Medicines Service on the prohibition of the circulation of counterfeit medicines and the information messages of law enforcement agencies in 2017–2020.

The object of the study was the orders of the State Medicines Service on the prohibition of the circulation of counterfeit medicines, information messages of law enforcement agencies to identify the facts of clandestine production and counterfeiting, publications on the problems of it’s distribution. The study used the methods of content analysis, systematization and generalization.

Тo prevent the circulation of counterfeit medicines in the countries of the world, various methods of countering counterfeiting are being introduced, however, only in Ukraine was the restriction of measures of state supervision (control) in the pharmaceutical sector introduced as an element of deregulation. In connection with this, it was investigated how such restrictions, which were introduced three times, has influenced the identification and distribution of counterfeit medicines.

For the study, a methodology for content analysis of official documents on the circulation of counterfeit medicines in the country for 2017–2020 has been proposed. In most of the orders of the State Medicines Service, revealed signs of drug falsification were introduced, which related to the labeling of packages.

The imposition of a moratorium on planned measures of state supervision had a negative impact on the work of quality control bodies of medicines to identify counterfeits. In 2010–2014 (before the introduction of the first moratorium) the State Medicines Service issued 326 orders prohibiting the circulation of counterfeit medicines, but after the introduction of the moratorium, the number of orders for 6 years decreased significantly – to 118. So, in 2020, the State Medicines Service issued only 4 orders to prohibit the circulation of counterfeit drugs (for comparisons in 2017 – 18), although law enforcement officers revealed 6 facts of clandestine production and counterfeit.

According to the results of the study, it was established that it was necessary to unify and standardize the management documents of the State Medicines Service on the prohibition of the circulation of counterfeit medicines, and also indicated the feasibility of introducing «field screening» of the often counterfeited medicines, to establish the real part of counterfeit medicines. Information messages from law enforcement agencies should not be limited only to the facts of revealing clandestine proceedings, but also should contain the results of court decisions on these facts. It is advisable to intensify interaction with regulatory authorities in other countries for a more effective exchange of information on detected of counterfeit medicines.