Biomedic innovations and clinical research - Competition and regulation

Clinical research is a central constituent in the development of new pharmaceuti-cals and other methods of medical treatment, because about half of the time and cost of RD&D is devoted to it. In spite of internationally recognised and legally codified directives there are large discrepancies in their implementation in different countries. German industry claims to suffer competitive disadvantages and a ten-dency to withdraw clinical research from Germany is obvious, which could have consequences both for employment and the supply of innovative medication to pa-tients. On the other hand new biotechnology-based treatments gain importance for industry and health care, e.g. »biosimilars«, therapeutic antibodies, gene- and cell-therapy, tissue engineering and nanoscale drug delivery. Because of their innovative mode of operation they could pose novel challenges and risks to clinical research but also to ethical and safety issues.
The project will take stock of new treatments and classes of agents and will assess the (national and EU-wide) framework of regulation with respect to the require-ments for further development. An international country comparison will clarify the German position in the international context.