PROBLEMATIC ISSUES OF DETECTION OF FALSIFIED MEDICINAL PRODUCTS DURING THE PERIOD OF MARTIAL LAW IN UKRAINE

Abstract

The study analyzes the problematic issues of detecting counterfeit medicines, preventing their distribution during martial law and the consequences of their use by patients, in particular, the scientific publications on the negative impact of the use of counterfeit medicines on public health and the health care system as a whole. A number of effective measures were identified to liberalize the import and circulation of medicines after the introduction of martial law, taken by the Cabinet of Ministers of Ukraine and the Ministry of Health of Ukraine. A content analysis of official documents of the State Service of Ukraine on Medicines and Drugs Control on the prohibition of circulation of certain or all batches of counterfeit medicines issued during the martial law regime was conducted, and official press releases published on the websites of Ukrainian law enforcement agencies, including the Security Service of Ukraine, the National Police of Ukraine and the Prosecutor General’s Office of Ukraine (regarding the detection of clandestine production and importation of counterfeit medicines into Ukraine during 2022–2023 were analyzed, as well as the regulatory acts, that introduced restrictions on the implementation of planned and unscheduled state supervision (control) measures in the field of circulation of medicines and their impact on the detection of counterfeit medicines since 2011, a comparative analysis of the number of orders of the National regulatory authority(NRA) to ban the circulation of counterfeit medicines before the introduction of the “moratorium” (2010–2014) on most of the state supervision (control) measures and after its introduction (2015–2023) was conducted, the statistics of recorded offenses related to the circulation of counterfeit medicines was summarized, the number of criminal offenses in which criminals were notified of suspicion and the materials of proceedings were submitted to the court were determined, and urgent measures to increase the effectiveness of combating the circulation of counterfeit medicines were proposed. All things considered, the results of the study demonstrate that a comprehensive approach to preventing the import, clandestine production and distribution of counterfeit medicines during martial law is necessary, as well as the increased involvement of authorities and law enforcement agencies in this process. Investigation and suppression of the channels of distribution of counterfeit medicines are important for ensuring the safety and quality of treatment of the population, and the adoption of effective national legislation and strengthening the institutional capacity of the NRA, along with the prompt implementation of the National Medicines Verification System, will significantly reduce the problem of counterfeit medicines in circulation.