NETHERLANDS Trends and Developments Contributed by: Hamza Zourakhti and Barbara van der Ven, Brande & Verheij LLP
• a decrease in the compliance burden for compa- nies (eg, biotech and medtech companies could benefit from this); • increased opportunities for testing AI systems; and • real-world testing. Product Liability and Increased Risk of Class Actions The new Directive (EU) 2024/2853 (the Product Liabil- ity Directive), which will enter into force on 9 Decem- ber 2026, has several important implications for the life sciences and medical devices industry. This new Product Liability Directive aims to modernise the product liability rules that have been in place for dec- ades in order to bring them into line with, inter alia, new technologies, including AI, new circular economy business models, and new global supply chains. The new Product Liability Directive introduces chang- es across the board. For instance, the definition of a “product” has been expanded to also include software and AI-integrated products (eg, AI-driven diagnostics). Furthermore, there is a higher risk for manufacturers, as they can be held liable for damages resulting from, inter alia, cybersecurity vulnerabilities in their products (a product can be found defective on account of such vulnerabilities). Notably, the Product Liability Directive also recognises the increased complexity of products, business mod- els, and supply chains, and seeks to ensure that con- sumers and other natural persons can easily exercise their right to obtain compensation in the event of dam- age caused by defective products. In that respect, it is important to note that damage claims can also include the destruction or corruption of data. Consumers can, under certain circumstances, also benefit from new (and consumer-friendly) rebuttable presumptions of defect and causation. The new Product Liability Directive is therefore expect- ed to provide consumers with more tools to obtain compensation. This development ties in with the col- lective actions regime that is gaining momentum in the Netherlands. Indeed, a major legislative reform was brought about by the Act on the Resolution of Mass Damages in Collective Action ( Wet afwikkeling mas- saschade in collectieve actie WAMCA), which entered
into force on 1 January 2020. The most important feature of the WAMCA is the possibility for interest organisations to also claim monetary damages in col- lective actions, which was previously not possible in the Netherlands. Collective actions continue to be brought under the WAMCA, including claims for mon- etary damages, but many of these collective actions are still in the preliminary and admissibility stages, leaving important questions as to the merits of these claims unanswered. Nonetheless, the combination of the WAMCA (and other collective action arrangements) and the pos- sibilities under the new Product Liability Directive requires close monitoring by life sciences and medical devices companies. Indeed, an increased risk of col- lective actions for life sciences and medical devices companies is to be expected. Pharmaceutical Pricing and Accessibility of Medicinal Products As medicinal products play an important role within the healthcare sector, it is of utmost importance that they remain accessible to patients. Indeed, the pric- ing of medicinal products has been a major topic for years, as expenditure on expensive medicinal prod- ucts has increased more rapidly than other healthcare expenses. It is expected that over the coming years the expenses related to expensive medicinal products will increase significantly. In that respect, the Dutch Competition Authority, the Dutch Healthcare Authority and the Dutch Health Care Institute have, as part of the “Societally Acceptable Expenditure on Medicines” programme, sought to identify which expenses are socially acceptable (and attach consequences to such findings). Their findings were published on 15 October 2025 in a comprehen- sive study titled “Towards Societally Acceptable Pric- es for Expensive Medicines”. To that end, it was concluded that • the assessment framework used by the Dutch Health Care Institute when advising the Minister of Health, Welfare and Sport (MoH) on the inclusion of medicines in the basic healthcare package (and at what price) requires updating;
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