SPAIN Law and Practice Contributed by: Xavier Moliner and Juan Martínez, Faus Moliner
3. Recent Policy Changes and Outlook 3.1 Trends in Product Liability and Product Safety Policy Directive (EU) 2020/1828 On 24 December 2020, Directive (EU) 2020/1828 of the European Parliament and of the Council of 25 November 2020 on representative actions for the protection of the collective interests of consumers, repealing Directive 2009/22/EC, entered into force. This Representative Actions Directive has not yet been transposed in Spain. One of the developments of this Directive is to include a system of disclosure of evidence that allows quali - fied entities intending to bring a representative action to request that the defendant or a third party discloses certain pieces of evidence under its control that are relevant for the action to be brought. This may lead to significant modifications of the structure of the Span - ish civil procedure regarding representative actions for the protection of the collective interests of consum - ers related to product safety infringement and product liability, among others. Directive (EU) 2024/2853 Another development in product liability and prod - uct safety policy is Directive (EU) 2024/2853 of the European Parliament and of the Council of 23 Octo - ber 2024 on liability for defective products, repeal - ing Council Directive 85/374/EEC. This new Directive on liability for defective products introduces certain measures that may have a relevant impact on product liability litigation, including the following. Concept of defectiveness A more precise, detailed and comprehensive definition of the parameters that outline the concept of defec - tiveness (which would continue to be based on the criteria of safety that a person is entitled to expect in accordance with the safety standards required under EU or national law) and a broader list of non-exhaus - tive circumstances to be considered when assessing defectiveness, including: • the presentation and characteristics of the product, including its labelling, design, technical features,
these cases, the other group company may indeed be sued. In the remaining cases, suing a group company other than the one that performed the acts leading to the alleged damage will pose serious difficulties to the claimants. The Supreme Court further stated that partially coin - ciding names between companies belonging to a corporate group is not a sufficient reason to sue a company for the acts carried out by another company of the same group. The Judgment of 7 February 2024 In this case, the Spanish Supreme Court ruled on the extinction of the liability time limit of ten years from the time the product is put on the market, during which an action based on the product liability regime of RDL 1/2007 can be brought. In this ruling, the Supreme Court pointed out that when a product liability claim is brought against a distributor that does not comply with its identification duties, this period of extinction starts when the distributor (not the manufacturer) put the product on the market. The Judgment of 27 January 2026 In this case, the Spanish Supreme Court examined whether adverse effects derived from COVID-19 vac - cination can give rise to state liability of the regional public health service responsible for administering the vaccine. The Supreme Court clarified that the extraordinary circumstances of the pandemic do not eliminate the general regime of state liability, but public health ser - vices are only liable when their actions breach the applicable standard of care (lex artis ad hoc) or the quality standards required in healthcare practice. Con - sequently, liability cannot be extended to damages arising from the inherent risks of scientific progress or the intrinsic characteristics of a medicine, provided that the healthcare service acted correctly.
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