New Product Liability Obligations for Pharmacies

The German product liability law is set for a comprehensive reform for the first time since 1989, prompted by the need to adapt to digital advancements, circular economy principles, and global supply chains. The European Union directive 2024/2853 must be integrated into national law by December 9, 2026. In this context, the Federal Ministry of Justice and Consumer Protection has presented a draft for a new Product Liability Act (ProdHaftG).

Key aspects of the reform include an expanded definition of products, which will now encompass software, artificial intelligence systems, and digital construction documents. Additionally, liability will extend beyond manufacturers to include importers, fulfillment service providers, suppliers, and certain platform operators, particularly when the manufacturer is based outside the European Union. Notably, the new product liability law does not impose a cap on liability, marking a significant change in the legal landscape.

This reform holds particular significance for pharmacies, especially regarding medical devices, digital health applications, and software solutions. However, it should be noted that pharmaceuticals are not included under this new legislation, as the existing specific liability provisions under the Medicines Act (AMG) will continue to apply.

A critical aspect of the new regulations is the establishment of subsidiary supplier liability. Pharmacies may be held liable as suppliers if they source products (excluding pharmaceuticals) from outside the EU and cannot identify the original manufacturer or supplier upon request. To mitigate this risk, thorough documentation of manufacturer and supplier information is essential.

Furthermore, the new legislation considers data destruction or damage as compensable harm, particularly affecting faulty software or digital systems, such as inventory management programs or electronic prescription infrastructures. While the primary liability lies with the manufacturers of these systems, pharmacies will need to enhance their IT security measures and documentation practices to comply with the new standards.

As these changes unfold, pharmacies must prepare for the evolving landscape of product liability, ensuring they understand their new responsibilities and take proactive steps to manage risks associated with the products they distribute.