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Product liability in transition: New requirements for pharmacies
Technical article on medical device law
Pharmacies face increased liability risks. The planned reform of product liability law brings new obligations, particularly regarding medical devices, digital health applications, and software-based systems. A current draft bill proposes significantly expanded liability rules and increased due diligence requirements for market participants.
Structural change in the pharmacy sector
For the first time since 1989, German product liability law is to undergo a comprehensive modernization. This is due to the implementation of EU Directive 2024/2853, which must be transposed into national law by December 9, 2026. The Federal Ministry of Justice and Consumer Protection has presented a draft bill for a new product liability law. The aim of the reform is to adapt liability law to advancing digitalization, new forms of value creation, and global supply chains. Particular attention is paid to the fact that many products now originate from manufacturers outside the European Union.
The ABDA (Federal Union of German Associations of Pharmacists) has commented on the draft legislation and highlighted key changes. The definition of "product" will be significantly broadened. In addition to traditional physical products, software, artificial intelligence systems, and digital design and development documents will also fall under product liability law. Furthermore, liability will no longer be limited exclusively to manufacturers. Other market participants, such as importers, suppliers, fulfillment service providers, and certain platform operators, can also be held liable, particularly if the manufacturer is based outside the EU. The new law no longer includes a maximum liability limit.
For pharmacies, the reformed product liability law is gaining importance, particularly in the areas of medical devices, digital health applications, and software solutions. Medicinal products themselves remain exempt from the reform, as the specific liability regulations of the Medicines Act continue to take precedence.
Increased due diligence obligations and IT-related risks
Of particular relevance is the planned subsidiary supplier liability. Pharmacies could be held liable as suppliers if they source non-pharmaceutical products from other EU countries and cannot identify the actual manufacturer or upstream supplier upon request. To avoid this risk, complete documentation of the supply and origin chain is becoming increasingly important.
What's also new is that the destruction or damage of data will now be considered compensable damage. This applies in particular to faulty software or digital systems, such as inventory management programs or e-prescription infrastructures. While primary liability in these cases usually lies with the system manufacturer, pharmacies will face increased demands regarding IT security, documentation, and internal control processes.
The reform makes it clear that pharmacies must reassess their role in the supply and usage chain of technical products. Careful organization, transparent supplier structures, and a responsible approach to digital systems will be crucial in the future to effectively limit liability risks.
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We will gladly advise you comprehensively and personally on your request.
FAQs – Frequently Asked Questions about the Product Liability Reform
Product liability law is undergoing its first comprehensive reform since 1989. In the future, digital products such as software, AI systems, and digital design documents will be explicitly classified as products. Furthermore, the circle of liable market participants will be expanded, and a maximum liability limit will be abolished.
The underlying EU Directive 2024/2853 must be transposed into German law by December 9, 2026. The new Product Liability Act is therefore expected to come into force no later than this date.
For pharmacies, the reform is particularly relevant in the handling of medical devices, digital health applications, inventory management systems, and other software. New liability and due diligence obligations may arise in these areas.
No. Medicinal products remain subject to the specific liability regulations of the German Medicines Act (AMG). The new Product Liability Act does not apply here, as the AMG remains the primary liability regime.
Yes, under certain conditions. Pharmacies can be held liable as suppliers, especially if they source products from other EU countries and cannot name the manufacturer or supplier upon request.
Subsidiary supplier liability applies when the actual manufacturer is located outside the EU or cannot be identified. In such cases, liability can be transferred to the supplier. For pharmacies, this makes careful documentation of the supply chain essential.
Software, including inventory management systems, e-prescription solutions, and digital applications, will henceforth be explicitly considered a product. Defective software can therefore cause damages that may give rise to liability claims, for example, through data loss or system failures.
Yes. Under the new product liability law, the destruction or damage of data will also be considered compensable damage. This increases the importance of IT security, data backup, and documented security measures in pharmacies.
Pharmacies should review their supplier and manufacturer documentation, critically examine IT systems and software contracts, and strengthen internal processes for documentation and traceability in order to reduce liability risks.
Specialized advice is particularly useful when assessing new liability risks, drafting supplier and software contracts, documenting supply chains, and dealing with regulatory or liability issues. Life Sciences Law supports pharmacies in implementing these new requirements in a legally compliant and practical manner.
contact
Your law firm LIFE SCIENCES LAW - Ralph Schäfer – Lawyer.
- +49 8151 4466683
- ralph.schaefer@lifescienceslaw.de
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Munich Street 33
82319 Starnberg