Working Groups
Clinical Trials of Medicinal Products on Humans
In July 2012 the European Commission submitted the proposal titled “Regulation of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC”. The goal of the Regulation is to harmonise the clinical trials of medicinal products on humans in Europe and to reduce the complications involved in conducting them.
According to frequently expressed criticisms, the proposal falls short of the safeguarding provisions that until now have been in effect in Germany; this is true regarding established procedural standards as well. The ad hoc statement jointly drafted by Leopoldina, the Union of German Academies and the Germany Academy of Science and Engineering acatech examines some of the ethically problematic aspects of the proposed Regulation that are considered to be of central importance.
Institutions
- Union of the German Academies of Sciences and Humanities
- German Academy of Science and Engineering acatech
- German National Academy of Sciences Leopoldina
Members of the Working Group
- Prof. Dr. Hubert Blum ML
Medizinische Universitätsklinik Freiburg - Prof. Dr. Georg Ertl
Zentrum Innere Medizin, Universitätsklinikum Würzburg - Prof. Dr. Philipp U. Heitz ML
Departement Pathologie, Universität Zürich - Prof. Dr. Otfried Höffe ML
Philosophisches Institut, Universität Tübingen - Prof. Dr. Peter Schaber
Ethik-Zentrum – Arbeits- und Forschungsstelle für Ethik, Universität Zürich - Prof. Dr. Günter Stock, Union
Präsident Berlin-Brandenburgische Akademie der Wissenschaften, Berlin - Prof. Dr. Günther Wess, acatech
Helmholtz Zentrum, München - Prof. Dr. Rüdiger Wolfrum ML
Max-Planck-Institut für ausländisches öffentliches Recht und Völkerrecht, Heidelberg - Prof. Dr. Hans-Peter Zenner ML (responsibility)
Universitätsklinikum Tübingen
Related Publications
Standing Committee
Standing Committee “Science and Ethics”
