Opinia prawna w sprawie zgodności z Konstytucją RP projektu rozporządzenia Parlamentu Europejskiego i Rady w sprawie badań klinicznych produktów leczniczych stosowanych u ludzi oraz uchylenia dyrektywy 2001/20/WE

The main point of the legal opinion is the question of conformity with Poland’s Constitution of the proposal for regulation of the European Parliament and of the Council [COM (2012) 369 final]. In provides an in-depth analysis of matter presented (only in general terms) in the opinion dated 27 August 2012. The author claims that Article 30(1) of the proposed regulation should be declared to be partly (i.e. in relation to the scope of regulation) inconsistent with Article 39 of the Constitution. He points out that the Constitution establishes a prohibition against medical experimentation on the human subject (and this notion includes clinical trials referred to in the proposed regulation) without his personal and prior consent. No limitation of this right is allowed, except for when it collides with other “equivalent” constitutional values, especially the right to life protection (Article 38 of the Constitution) and the right to health protection (Article 68 of the Constitution).