Opinia na temat projektu rozporządzenia Parlamentu Europejskiego i Rady w sprawie badań klinicznych produktów leczniczych stosowanych u ludzi oraz uchylenia dyrektywy 2001/20/WE

The main subject of the analysis is the question of conformity with Poland’s Constitution of the possibility of carrying out clinical trials on minors. The author concludes that the provisions of Article 31 of the proposed regulation of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC, providing for the possibility of conducting clinical trials on minors, which are not aimed to be delivered for health benefit of those persons, are inconsistent with Article 39 of the Constitution of the Republic of Poland.