Sfałszowane produkty lecznicze. Analiza polskich przepisów (Falsified medicinal products. Analysis of Polish regulations)

Małgorzata Kubacka

Warszawski Uniwersytet Medyczny

Law and Forensic Science, Volume 18 (2019/2)

Submitted: January 22, 2019

Abstract: The problem of falsifications of medical products WHO applies to 1% of the value of drugs sold in highly industrialised countries and 10% of countries with low and very low income. Polish Pharmaceutical Law regulations in the field of crime of falsification of medicinal products and active substances is a result of the implementation of the Directive 2001/83/EC as amended by Directive 2011/62/EU (Falsified Medicines Directive). The article 124b has been introduced as the most significant transposition of Directive and according to this article manufacture, delivering and sharing, as well as storage to provide falsified medical products or falsified active substances is punished with fine, restriction of liberty or imprisonment of up to five years. This is an intentional crime, no-effect and widespread. Application of the Pharmaceutical Law regime is possible provided that the counterfeit product meets the requirements for the medicinal product. Polish legal solutions were positively evaluated in the report on the implementation of Article 118a of the Falsified Medicines Directive by the legislators of the Member States, prepared by the Directorate-General for Health and Food Safety for the European Parliament and the Council. Unfortunately, the implementation of the EU recommendations on educating the public about the risks of falsified medicines leaves a lot to be done in this regard. It is worth noting that different concepts are used in the field of drug forgery crimes – counterfied medicines, falsified medicines, substandard medicines or fake medicines. They all differ from each other, although they describe the same problem. Ministry of justice statistics show a very low percentage of convictions (0.014%) from the provisions of criminal articles of Pharmaceutical Law compared with all convicted adults in Poland in the years 2002-2017. With the growing phenomenon of selling drugs of unknown origin on the Internet – it’s worth asking if we have a problem with the detection of crime of falsifications or in the case of Article 124b of the Pharmaceutical Law, we are already dealing with desuetudo?

Keywords: falsified medical products, Falsified Medicines Directive, Pharmaceutical Law

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