Germany – Drug shortages in Germany ‒ A critical appraisal

The article discusses drug shortages in Germany the root causes of production problems with active pharmaceutical ingredients and drug product manufacturers. The authors offer analysis from a medium-sized generic drug manufacturer’s perspective. They offer a variety of reasons, all of which point to a “broken marketplace.” The article concludes with a discussion of mitigation activities and in an epilog address the current COVID-19 pandemic, warning that drugs and active ingredients from China and India may be in short supply because of the disruption caused by the pandemic.

Introduction

All pharmaceutical manufacturers aim to meet market demand in a timely manner while maintaining the highest possible standards of quality. Nevertheless, drug shortages occur to varying degrees in most countries, although the root causes can vary substantially. It makes a great difference for patients whether a shortage of their medication is temporary and limited, with alternative medicines available, or whether there is no available substitution for the duration of the shortage last.1 Figure 1 shows the complexity of the supply chain by showing the various stakeholders/economic operators involved in drug supply and how they interact…