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

• Authors: Bogusław Banaszak

Title variants

EN

Legal opinion on the conformity with Poland’s Constitution of the proposal for a regulation of the European Parliament and of the Council on clinical trials on medicinal products for human use

Abstracts

EN

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.

Keywords

EN

Constitution; clinical trials; European Union; health care

• Publisher: Kancelaria Sejmu / Chancellery of the Sejm
• Journal: Zeszyty Prawnicze BAS
• Year: 2012
• Issue: 4(36)
• Pages: 107-117

Dates

published

2012

Contributors

author

Bogusław Banaszak

• Uniwersytet Wrocławski

Identifiers

Biblioteka Nauki

16728916