EUCOPE Legal Working Group meeting features lecture on in-vitro diagnostics regulation

The EUCOPE Legal Working Group met in Berlin in late June to discuss and evaluate the latest legal developments in Europe. Items on the agenda were the European Commission’s inventory of incentives that streamline the approval of biotech drugs and pharmaceuticals, the implications of the recent judgment on mixed pricing within the AMNOG process as well as the new regulations concerning the reimbursement of companion diagnostics in Germany. In addition, a representative from BIO Deutschland’s office gave the legal experts an overview of the key changes brought about by the new EU regulation on in-vitro diagnostics as well as its impact on Europe’s position as a location for the pharmaceutical industry.