A coalition of fourteen pharmaceutical companies has filed lawsuits against the European Union’s Urban Wastewater Treatment Directive (UWWTD), adopted in November 2024. The legal actions, lodged in March 2025 before the General Court of the European Union, argue that the directive imposes disproportionate financial burdens on medicinal and cosmetic product manufacturers, potentially setting a precedent for extended producer responsibility (EPR) across multiple sectors.
Directive introduces EPR scheme for micropollutant removal
The contested UWWTD mandates quaternary treatment upgrades in urban wastewater plants to remove micropollutants, including pharmaceutical residues. Articles 9 and 10 of the directive establish an EPR scheme requiring relevant producers to cover up to 100% of associated costs. Pharmaceutical firms assert this policy violates legal and procedural norms under EU law, and that it targets their sector unfairly.
Plaintiffs such as Accord Healthcare, Zentiva, Teva, and Laboratorios Normon claim the directive was adopted using an incorrect legal basis under Article 192(1) of the Treaty on the Functioning of the European Union (TFEU), which applies to environmental matters. They argue that due to the fiscal nature of the obligations, Article 192(2)(a)—requiring unanimous Council approval—should have been used.
Implications across the manufacturing value chain
Beyond legal technicalities, the lawsuits underscore broader concerns about regulatory fairness and cost distribution. Producers argue the EPR scheme lacks clarity on implementation, including cost calculation methods and criteria for exemptions (e.g., “rapidly biodegradable” substances). Industry stakeholders also fear unintended consequences for public health, as the directive could disincentivise the development of vital pharmaceuticals, particularly where structural redesign of active ingredients is not viable.
Although no trade associations have joined the legal action, the coordinated filings suggest widespread concern across the sector. These cases will likely influence how future EU environmental regulations allocate responsibilities among stakeholders in pharmaceuticals, cosmetics, and beyond.
Next steps and regulatory outlook
A ruling by the General Court could redefine the scope of EPR obligations in EU legislation, shaping future compliance expectations for chemical-intensive industries. Companies across the manufacturing value chain should monitor developments closely and evaluate potential operational and legal impacts.
