Amendment to the Medicines Act: Only some measures lead to more patient safety

20.11.2018 10:43

The draft of a “Law for More Safety in the Supply of Medicines” (GSAV) presented last Friday (11/16/18) by Federal Health Minister Jens Spahn certainly contains good approaches. However, some of the measures included do not contribute to greater patient safety. Other important measures are missing.

“We welcome the fact that the coordination function and recall authority of the higher federal authorities, i.e. the Federal Institute for Drugs and Medical Devices (BfArM) and the Paul Ehrlich Institute (PEI), are to be strengthened. This means, among other things, that recalls can be carried out more effectively and any bottlenecks can be avoided,” comments Dr. Martin Weiser, General Manager of the Federal Association of Drug Manufacturers (BAH), the amendment to the law. “Unfortunately, there are no further measures to reduce the risk of supply bottlenecks, such as a legal requirement that health insurance companies must conclude discount agreements with at least three manufacturers,” adds Weiser.

Weiser is also critical of the plan to promote the exchange of biosimilars: “Biological drugs are many times more complex than chemically defined ones. Drug therapy safety means that reports of side effects can be clearly identified and traced. This must take priority over any austerity measures. Substitution without the attending physician ordering it endangers patient safety.”