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Agata Wnukiewicz-Kozłowska

Abstract

The article consists of four parts. The first one in a short way presents the notion of biomedical law. In the second part the author points out the main ways of harmonisation of the internal law of the Member States of EU by directives. The next part is dedicated to the polish laws connected with the biomedical law. The author analyses two EU directives: the first one about the principles of Good Clinical Practice – the document which is a set of internationally recognised ethical and scientific quality requirements which must be observed for designing, conducting, recording and reporting clinical trials that involve the participation of human subjects and the second one about patenting biomedical inventions, comparing them to Polish legal solutions in this field. The last part – conclusions – presents the opinion of the author about the concordance of polish and EU law in the field of biomedicine.

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Section
Articles