EU wastewater directive legal challenge

The European Union’s wastewater directive is facing legal scrutiny regarding its funding model for removing micro-pollutants. Juliane Kokott, an Advocate General at the Court of Justice of the European Union, has proposed the annulment of provisions requiring the pharmaceutical and cosmetic industries to cover at least 80 percent of the costs for quaternary wastewater treatment.

This model utilizes the Extended Producer Responsibility (EPR) principle, based on the ‘polluter pays’ concept. Industry groups, such as Medicines for Europe, have warned that because prescription drug prices are regulated by states, manufacturers may be unable to pass these costs to consumers. Such financial pressure could impact the production, quantity, and availability of medicines.

Following the Advocate General’s conclusions regarding a legal challenge brought by Poland, the association Egualia has urged the Italian government to suspend the implementation of the directive. Egualia argues that the EPR system could make essential, low-cost medicines—including generic and biosimilar drugs—economically unsustainable due to low profit margins.