Germany’s strategy to bolster domestic pharmaceutical production and reduce reliance on Chinese and Indian antibiotic imports appears to be faltering, according to a recent investigation. The law, enacted two and a half years ago and championed by former Health Minister Karl Lauter, mandates health insurers to prioritize European-manufactured active pharmaceutical ingredients (APIs) in their procurement processes. However, the initiative has failed to incentivize any European manufacturer to establish new production facilities or expand existing ones.
The core objective of the legislation – to ensure a more secure and resilient supply chain – is undermined by the practical difficulties encountered by health insurers. Investigations reveal they struggle to find European suppliers for many crucial antibiotic APIs. Only approximately half of the tenders issued have resulted in successful sourcing from within the EU, with substantial orders for commonly prescribed antibiotics continuing to flow to Asian producers.
The perceived ineffectiveness of the law raises serious questions about the government’s approach to addressing critical supply chain vulnerabilities and risks. While the Ministry of Health has announced an evaluation of the “Act to Combat Drug Supply Bottlenecks and Improve Supply Security” by the end of the year, initial data suggest a negligible impact on the number of reported supply shortages. The Federal Institute for Drugs and Medical Devices currently registers 553 active bottlenecks, spanning a wide range of medications.
Anke Rüdinger, Deputy Chair of the German Pharmaceutical Association, voiced concerns about the potential consequences, warning that a widespread shortage during the winter months could create significant challenges for the healthcare system. The inability to attract investment and effectively diversify sourcing demonstrates a potential disconnect between legislative intent and practical implementation, prompting a critical review of the policy’s design and efficacy. The evaluation, therefore, will be closely scrutinized for recommendations to either strengthen the current framework or pursue alternative strategies to ensure Germany’s pharmaceutical independence and patient safety.