Is the administration of pharmaceutical drugs from other European Union countries a crime of placing medicinal products on the market without a permit? Considerations against the background of Art. 124 of the Pharmaceutical Law

Abstract

Art. 124 of the Pharmaceutical Law penalizes the act of placing a medicinal product on the market without a marketing authorization. On the basis of this provision, consideration should be given to the worrying practice of instituting criminal proceedings by law enforcement agencies against doctors, who administer to patients, pharmaceutical drugs manufactured in other EU countries, than Poland. The subject of the first part of the article is to answer the question whether the administration of medicinal products to patients, as part of the conducted medical practice, constitutes an act of placing on the market at all. For this purpose, the notion of medical services and treatment in terms of Polish law, doctrine and Community regulations was analyzed. Subsequently, the subject of considerations is the characteristic of "placing on the market" under Art. 124 of the Pharmaceutical Law, not defined in this Act. Against the background of the judicial activity of the Supreme Court and common courts, an clearly view can be formulated, that the perpetrator of the act may only be the person who made the first transaction with a medicinal product, transferring its possession for further circulation by physically handing it over to the recipient. This position is also confirmed by other penal provisions of the Pharmaceutical Law, which use additional features of "use" and "sharing" of a medicinal product. Thus, it should be considered that in Art. 124 of the Pharmaceutical Law, the legislator decided to criminalize only the act of placing medicinal products on the market, without providing for a criminal sanction for their use, delivery or making available.