Falsification of medical products: criminal law mechanism combating threats to public health

Nataliya Gutorova, Oleksandr Zhytnyi, Oleksii Soloviov
Wiadomości Lekarskie: Organ Polskiego Towarzystwa Lekarskiego 2019, 72 (5 cz 1): 856-861

OBJECTIVE: Introduction: Every civilized state has the duty to its citizens to create an effective health care system, a necessary component of which is the use of safe and high-quality medical products. This duty is based both on the standards of international law and national constitutional norms and principles. The spread of falsified medical products poses a global threat to public health, can lead to death or cause significant harm to human health. Given the extreme risk of such acts, there is a need to create and operate an effective criminal law mechanism to combat such acts. The aim: The purpose of the article is to study the existing criminal law mechanism to combat the falsification of medical products at the international, regional and national levels (Poland and Ukraine as an example), as well as to develop proposals for improving of such a mechanism.

PATIENTS AND METHODS: Materials and methods: This study is based on the empirical and analytical data of the WHO, the United Nations Convention against Transnational Organized Crime, the Council of Europe Convention on the counterfeiting of medical products and similar crimes involving threats to public health (The Medicrime Convention), criminal legislation of Ukraine and Poland, General Prosecutor's Office data on the criminal liability of those who committed falsification of medicines. Totally 28 laws and papers, 25 court judgments were analyzed. Dialectical, comparative, analytic, synthetic and system analyses research methods were used, also for interpretation purposes.

RESULTS: Results:Falsification of medical products worldwide is characterized by high prevalence and is one of the highly profitable activities of transnational organized crime. Therefore, an effective counteraction to these crimes is impossible through isolated actions by one separate State and requires the establishment of a multi-level integrated mechanism to combat this phenomenon. The criminal law mechanism, as a necessary component of abovementioned mechanism, should be established at the international, regional and national levels. An analysis of the situation in Poland and Ukraine showed that the falsification of medical products is quite common in these countries, but national criminal legislation and practice of its implementation needs improvement.

CONCLUSION: Conclusions: There is a need to create and implement an effective criminal law mechanism (at international, regional and national levels) to combat the spread of falsified medical products. At the international level, in order to increase the effectiveness of this mechanism, we fully support the EU initiative to amend the United Nations Convention against Transnational Organized Crime, which would establish additional liability for the falsification of medicines. Improving the criminal law mechanism to combat the falsification of medical products at the European regional level requires intensifying of The Medicrime Convention ratification process and full implementation of rules on criminal liability for falsifying medical products into national criminal legislation. At the national level, it is necessary to improve both the criminal legislation and the practice of its implementation, to intensify the activity of law enforcement agencies to combat these crimes, to ensure a fair trial and effective criminal penalties for those who have committed a crime of falsifying medical products.

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