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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