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

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Bosek L., Olejniczak D.

Zeszyty Prawnicze BAS

2012

issue 4(36)

118-148

The purpose of the opinion is to examine thoroughly the proposal for a regulation of the European Parliament and of the Council on clinical trials on medicinal products for human use. Presently, the issue of clinical trials is regulated differently in particular EU member states, due to their different legal traditions and constitutional standards. By allowing for experimentation on human beings without their knowledge or consent, the proposed regulation substantially infringes the principles of subsidiarity, proportionality and conferred competences, as well as human dignity and the right to integrity of the person guaranteed by Articles 1 and 3 of the Charter of Fundamental Rights of the European Union. These circumstances sufficiently justify initiation by the Polish Sejm of the procedure specified in Article 6 of Protocol 2 on the application of the principles of subsidiarity and proportionality annexed to the Lisbon Treaty.

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1 Zeszyty Prawnicze BAS

1 Bosek L.

1 Olejniczak D.

1 2012

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