Opinia prawna w sprawie zgodności z Konstytucją RP projektu rozporządzenia Parlamentu Europejskiego i Rady w sprawie badań klinicznych produktów leczniczych stosowanych u ludzi

The purpose of the opinion is not to examine thoroughly the proposal for a regulation but only to assess the legal basis for its issue, and to provide an analysis of those provisions of the proposal that may raise doubts about their conformity with the Constitution of the Republic of Poland. The main conclusions of the opinion relate to the lack of grounds for delegation by the Republic of Poland to the bodies of the European Union of the competence to regulate the issue of clinical trials on medicinal products for human use under primary law of the EU. Such delegation would infringe Article 90(1) of the Constitution. The author claims that the time limits specified in the proposal for regulation for action of the State make it impossible for Polish public authorities to implement obligations resulting from the preamble to the Constitution and their duties relating to protection of individual’s rights referred to in its Article 30.