The article raises the question of the influence of the EU clinical trials of me- dicinal products legislation on the Polish criminal law. Although this issue does not fall within the scope of the Article 83 of the Treaty on Functioning of the European Union, its significant importance results from the expected beginning of application of the Regulation No. 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC. The impact of the EU legislation on member states’ criminal law in the field of clinical trials is based on the principle of pri- macy. Three directions of this impact can be distinguished concerning Regulation No. 536/2014. The first is the exclusion of the unlawfulness of the acts prohibited by the chapter 19 of the Polish Criminal Code within the scope of the prerequisites for the admissibility of clinical trials. The second is the de facto depenalisation of the behaviors described by in Article 126a (1) (3–5) of Pharmaceutical Act. The indicated two effects may take place ex lege with the beginning of application of Regulation No. 536/2014, if there is no change in the Polish law beforehand. The realisation of the third direction depends on the decision of the Polish legislator, who is required to introduce effective, proportionate and dissuasive penalties applicable to infringements of the Regulation No. 536/2014. The type of these measures is left to the discretion of the member states, but the current legal situation combined with the principle of assimilation prompts us to suppose that the choice of criminal penalties will be sustained.
https://doi.org/10.32082/fp.v0i2(58).314
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