This collection examines product liability and the contracts and regulatory obligations surrounding life-sciences supply chains. Topics include manufacturing, environmental assessment, medicine shortages, human-origin starting materials, supply-chain due diligence and pharmacovigilance agreements.
These articles provide general information and are not legal advice.
Directive (EU) 2024/2853 governs products placed on the market from 9 December 2026, so two batches of one medicine can fall under different regimes. The new rules let courts presume a defect in defined cases, order disclosure and allow claims for up to twenty-five years.
When a contaminated batch harms a patient, any party in the supply chain may face a claim. From December 2026 the new EU Product Liability Directive reaches more of them and eases proof, while the Swiss statute is still modeled on the 1985 directive.
For antimicrobials, the EU Pharma Package extends environmental risk assessment to active-ingredient sites outside the EU. Unaddressed risks can lead to refusal or revocation of the marketing authorization. Supplier contracts rarely secure the effluent data.
Shortage prevention plans and a Union list of critical medicines become standing law, while joint antimicrobial procurement stays voluntary. The duties fall on whoever holds the marketing authorization, whether a US sponsor's EU subsidiary or its distributor.
From 7 August 2027 the EU Regulation on substances of human origin replaces the Blood and Tissues and Cells Directives, extending EU oversight of donated starting materials up to the manufacturer's door and requiring US cell and gene therapy sponsors to repaper supply agreements.
A life-sciences group can fall under the EU due diligence directive as narrowed in 2026, Germany's supply chain act and the Swiss code of obligations; they differ on scope, depth, enforcement and liability. A broader draft Swiss act on sustainable corporate governance (NUFG) entered consultation in April 2026.
A US sponsor, an EU licensee and a Swiss distributor answer to three pharmacovigilance regimes. Their safety data exchange agreement allocates the work but not the duty, and since February 2026 EU law prescribes what it must say.
The EU's new product-liability rules expressly cover software. Germany's pending bill, legacy devices and continuing control raise distinct questions about evidence, defenses and expiry for US makers of medical software and connected devices.
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