gms | German Medical Science

27. Deutscher Krebskongress

Deutsche Krebsgesellschaft e. V.

22. - 26.03.2006, Berlin

Transposition of the Clinical Trials Directive and the GCP-Directive into German law - a comparison of the current state with other EU member states

Meeting Abstract

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  • corresponding author presenting/speaker Markus Hartmann - European Consulting & Contracting in Oncology, Trier, Deutschland
  • Florence Hartmann-Vareilles - Europäische Rechtsakademie, Trier

27. Deutscher Krebskongress. Berlin, 22.-26.03.2006. Düsseldorf, Köln: German Medical Science; 2006. DocOP616

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Veröffentlicht: 20. März 2006

© 2006 Hartmann et al.
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Background: The Clinical Trials Directive 2001/20/EC and the GCP-Directive 2005/28/EC mark a water-shed for the conduct of clinical trials in Europe. Under the new legislative framework, the initiation and conduct of clinical trials is subject of comprehensive regulatory and administrative rules which are issued by each member state of the European Union (EU) following the provisions of both Directives. Future clinical trials from commercial, but to a larger extent from non-commercial sponsors, have to take into consideration, to which extent national legislations, in Germany nominally the 12. AMG-Novelle, allow for alleviations and provide pragmatic/financial support of such trials.

Methods: Legislative texts, ordinances, guidelines from competent authorities as well as informal guidance documents from Germany and six other EU member states with a traditionally high impact on cancer research were analysed in a comparative manner in order to highlight to which extent national legislations take into accounts the needs of clinical cancer research, especially of non-commercial clinical trials. Major differences and alleviations allowed for non-commercial trials are tabulated and commented.

Results: Both EU Directives were interpreted differently along the EU member states analysed so far. Several member states (Sweden, Belgium, and Italy) have introduced specific provisions for non-commercial clinical trials into their new legal framework in order to keep or even augment the number and density of clinical trials conducted on their territory. Other member states (France, UK and Spain) have like Germany missed the opportunity, to promote actively the undertaking of academic clinical research and to stop the move of trials and trial-empowering funding to Eastern Europe and Asia. Only the first three mentioned EU member states have expressively added alleviations for non-commercial trials into their legislation, allowing e.g. for the reimbursement of commercially available products ins some circumstances, for simplified or exempted submission of an Investigational Medicinal Product Dossier (IMPD) to competent authorities, or for exemptions from fees for IRB/dossier approval.

Conclusion: In each EU member state, the increased regulatory burden renders the conduct of clinical trials more difficult. Clinical research e.g. in cancers with rare incidences or in paediatric oncology will face tremendous challenges to set-up in the future a sufficient number of clinical trials to offer valuable treatment options to patients affected by cancer. In Germany, uncertainties in reimbursement of supplies used in clinical trials and insufficient funding for the set-up of specialised structures to carry out complex organisational projects like randomised trials will result in reduction of research activity and a loss of competitiveness not only at an international, but also at EU level.