EU liability directive for defective products set to impact Spain's pharmaceutical sector
Published on 23rd Jan 2025
Companies need to focus on safety and accessibility compliance before the directive enters national law in late 2026
Directive (EU) 2024/2853 of 23 October 2024 on liability for defective products repeals and replaces the regulations contained in the Council Directive 85/374/EEC of 25 July 1985, transposed in Spain by Law 22/1994 of 6 July on civil liability for damages caused by defective products and subsequently compiled in Royal Legislative Decree 1/2007 on the General Law for the Defense of Consumers and Users.
The new directive aims to modernise and adapt the product liability regime to recent developments related to new technologies, circular economy business models and global supply chains.
The directive applies to products placed on the market or put into service after 9 December 2026 and, therefore, it will have to be transposed in national law before that date.
Objective scope
The directive significantly widens the material scope of liability for defective products by explicitly including software, for example: artificial intelligence (AI) systems or applications; related digital services such as remote temperature monitoring systems for medicines; digital manufacturing files such as 3D printers; and intangible products, including raw materials such as electricity, gas and water.
It will have a significant impact on pharmaceutical services, as there are new products that now fall within its scope. These include AI systems applied to medical devices and health monitoring services that rely on physical product's sensors to track the user's physical activity or health metrics.
Additional criteria for determining the defectiveness of a product is also established. The assessment of defectiveness should involve an objective analysis of the safety that the public at large is entitled to expect by taking into account, among other things, the intended purpose, reasonably foreseeable use and technical characteristics of the product as well as the moment in time the product leaves the manufacturer's control.
Finally, the concept of damage is widened to include damage to psychological health.
Subjective scope
The subjective scope of liability is extended by expressly including new economic operators as liable parties. The new directive covers programmers and operators that substantially modify a product, providers of related digital services and fulfilment service providers when a manufacturer and importer is established outside the European Union.
Online platforms are also included when the average consumer is led to believe that the product is provided either by the online platform itself or by a trader acting under its authority or control, and only when the online platform fails to promptly identify a relevant economic operator established in the Union.
New liability measures
In the interest of a fair appointment of risk, new measures are included to alleviate the claimant's burden of proof. Likewise, new mechanisms for the disclosure of evidence are introduced and a new regime of presumptions (iurs tantum) on the assessment of defectiveness is also established. For example, the defectiveness of a product is presumed when the defendant fails to comply with the obligation to disclose the relevant evidence that is at his disposal, or when the claimant demonstrates that the product does not comply with mandatory product safety requirements laid down in the Union or national law.
The directive maintains a 10-year limitation period, after which the injured person is no longer entitled to compensation. However, a new exception is introduced extending the expiry period to 25 years for latent personal injuries, a change particularly relevant for the pharmaceutical sector.
Osborne Clarke comment
This new directive poses a number of challenges for companies. The new measures will require considerable effort from Member States and companies to ensure compliance. Economic operators will need to review contracts, general conditions, policies, instructions and product warnings to ensure that they comply with the safety requirements of the directive.
Furthermore, companies will be required to implement effective systems to record, store and manage information so that such information is presented in an accessible and understandable manner when required by the courts. This new regulation implies not only a regulatory change but also a profound operational transformation.
