German Government Plans for Regulator Changes Criticised

Germany's main medical association has heavily criticised proposed radical changes to the role of key regulatory agency BfArM. The body monitors safety and grants marketing approval for all other pharmaceutical products other than blood agents and vaccines, but doctors allege the proposals would effectively turn BfArM into a service provider for the drug industry.

According to medical representative groups, the new proposals fail to establish the safety of drugs and patients as the core priority of BfArM, or the Federal Institute for Drugs and Medical Devices. Furthermore, the government's draft proposals include terms linking the body's funding structures to numbers of new drug applications and timescales for successful product approvals.

Consequently, doctors fear that the measures would encourage the agency to prioritise speedy approvals at the expense of proper evaluation of potential risk factors. Opponents will also highlight the government's recent record of ambitious cost-cutting attempts, and there is the possibility that the new priorities will accelerate approvals of cheaper generic products. Although the measures could also reduce the seemingly ever-lengthening time ethical drugs take to come to market, the proposals' mention of "export quotas" and "competitiveness" could imply a further sop to Germany's sizeable generics industry.