Advanced Cell Therapies: From 1 January 2008 the new European Law Will Come into Effect

At the end of May 2007, the European Council adopted the regulation on new therapies in the first reading. The aim of the regulation is to establish a tailor-made certification system for innovative therapeutic methods. Along with cell and genetic therapies, tissue engineering is one of these methods. In the future, patients in Europe will be treated with products that have been manufactured to uniform standards. BIO Deutschland’s Working Group on Regulatory Affairs expressed its views on several critical points in the run-up to the debate. The association spoke out in favour of the possibility of the licensing of new cell therapies at the national level – along with the establishment of a central European licensing authority – which would be of particular benefit to biotech companies working with autologous tissues. The European central licensing procedures involve costs of around 270,000 euro. Although a compromise by the European Commission, the European Council and the EU Parliament led to agreement on an extensive range of amendments that also provides some relief for small and medium-sized enterprises, this did not include all the necessary measures.