Pharmaceutical inspection – decentralization issues

Abstract

The rationale for decentralizing the structure of the pharmaceutical inspection was undoubtedly the need for it to be distributed, in so-called ‘field’, in order to include all entities subject to inspection and located in different locations by the inspection. This decentralized structure was approved by the legislator in Article 112 of the Pharmaceutical Law. On the one hand, a decentralized structure of pharmaceutical inspection bodies makes it possible to react without delay to emerging problems related to the marketing of medicinal products and medical devices, and also controlling and providing direct access to local drugstore operators, drug wholesalers, drug manufacturers etc., and also direct access to local pharmacists, wholesale owners and producers etc., and the citizens’ access to them as well. On the other hand, existence of local pharmaceutical inspection organs which perform their tasks regionally (locally) leads to differences in the assessment of the facts in terms of their compliance with the legal standards applicable in the case, and as a result, differentiated settlement of similar issues. There are also difficulties experienced in appropriately utilizing the human resources of the provincial pharmaceutical inspectorates and in proper division of supervisory powers over provincial pharmaceutical inspectors between GIF (Główny Inspektor Farmaceutyczny, Main Pharmaceutical Inspector) and voivods. Considering the practical implications of the current division of pharmacy inspection tasks between GIF and voivods, the predominance of  adverse effects predominate.