Germany to Restructure Regulatory Regime

Germany's federal cabinet has approved a series of major revisions to the country's regulatory infrastructure. Upon final approval, the revised National Pharmaceutical Law will change the role of both the country's Health Funds and drug regulator BfArM, which will become known as the German Drugs and Medical Products Agency (DAMA).

A key change for the regulator will be a shift in emphasis to monitoring the safety of drugs which have already received marketing approval. DAMA will also be a legally distinct, autonomous institution separate from the federal government, a move which has long been urged by the many in the health system. Some observers now hope that the regulator's new structure will accelerate drug approvals, although medical groups recently warned that this could increase over-reliance on company clinical trial data and fail to adequately evaluate public health risks.

The changes are also expected to have significant financial consequences for Germany's Health Funds, which will now directly supply drugs to all hospitals involved in clinical trials. The government insists that the move will strengthen German R&D, and officials will have opted to introduce the change in view of the funds' recent strong financial results. Nevertheless, controversy over the measures is unlikely to end soon, in view of opposition from both the research-based sector and medical groups over the government's ambitious wider reform plans for healthcare.