Introduction
Ensuring the supply of medicinal products and medical devices is of major importance for maintaining the public's health. In order to ensure a reliable supply for the population, the German legislature does not leave manufacturers to themselves, but has taken various measures to prevent supply shortages.
Legal measures to prevent medicinal product supply shortages
The legal basis for this is Section 52b para. 1-3 of the German Medicinal Products Act (AMG), which obliges pharmaceutical companies and wholesalers to ensure an adequate and continuous supply of medicinal products. While pharmaceutical companies are obliged to ensure delivery to wholesalers (Sec. 52b para. 2 s. 1 AMG), wholesalers are obliged to ensure delivery to pharmacies (Sec. 52b para. 3 s. 1 AMG). To ensure supply, the legislator has established various measures to prevent impending supply shortages or to respond to existing supply shortages:
- Pharmaceutical companies are legally obliged to inform hospitals immediately of any known supply shortages (Section 52b para. 3a AMG).
- An advisory board is being set up at the Federal Institute for Drugs and Medical Devices (BfArM) to continuously monitor and evaluate the supply situation for medicinal products (Section 52b para. 3b AMG).
- The BfArM will compile lists of active ingredients relevant to supply and publish these on its website alongside reported shortages (Section 52b para. 3c AMG).
- The BfArM will set up an early warning system to identify impending supply shortages of medicinal products that are relevant to supply (Section 52b para. 3g AMG).
- In the event of an impending shortage, the law allows appropriate measures to be taken to prevent or mitigate supply shortages (Section 52b (3d) AMG), such as ordering quotas and stockpiling.
Legal measures to prevent medical device supply shortages
The measures taken by the German legislature to prevent supply shortages are almost exclusively related to pharmaceutical law. In contrast, the threat of shortages of medical devices has been somewhat neglected by the German legislature. In recent years, shortages of medical devices have mostly been addressed by the European legislature rather than the German legislature due to shortages during the transition from the old legal framework to the Medical Device Regulation (EU) 2017/745 (MDR), for example by issuing Art. 59 and Art. 97 MDR as well as by extending the transition periods of Article 120 MDR.
