Important step towards a proportionate approach that protects water quality and access to affordable medicines

Brussels, 3 September 2026 – AESGP welcomes today’s Opinion of Advocate General Juliane Kokott in Case C-193/25, Poland v Parliament and Council, concerning the Extended Producer Responsibility (EPR) scheme introduced under the revised Urban Wastewater Treatment Directive (UWWTD).

The Advocate General proposes the annulment of Article 9(1)(a) and Annex III of the Directive, which require pharmaceutical and cosmetics producers to finance at least 80% of the costs of quaternary wastewater treatment.

While the Opinion is not binding and the final judgment of the Court of Justice remains outstanding, it represents an important development in the legal procedure and reinforces the need for an approach that is fair, proportionate, evidence-based and environmentally effective.

The Advocate General has pointed out certain shortcomings regarding the file, that had previously been raised by pharmaceutical and cosmetics industry, such as:

• insufficient demonstration how evidence was assessed (AG §30, 93-94)
• insufficient justification for excluding other sectors (AG §43, 80-85)
• erroneous assessment of the underlying data and facts (AG §68, 79, 94-96)

For AESGP, this debate is about more than industry costs. Europe needs to improve water quality while ensuring that environmental measures do not undermine access to affordable medicines or the sustainability of healthcare systems.

“AESGP fully supports the objective of cleaner water and reducing micropollutants in the environment. The Advocate General’s Opinion confirms that ambitious environmental policies must also be founded on robust science, transparency, proportionality and fairness. Environmental objectives and public health objectives must go hand in hand.”

— Oliver Hartmann, Acting Director General, Director Regulatory and Legal Affairs, AESGP

AESGP remains committed to contributing constructively to solutions that improve water quality and ensure that all relevant contributors play their part. Europe needs an approach that avoids free-riders, respects the polluter pays principle and protects patients’ continued access to affordable and available medicines.