Brussels, 15 October 2025 – As the European Commission prepares to publish a long-awaited study on the costs associated with implementing quarternary-level treatment upgrades under the Urban Wastewater Treatment Directive (UWWTD), Europe’s pharmaceutical industries say that lessons have not been learned and the same mistakes are set to be repeated.

The industries, represented by AESGP, EFPIA and Medicines for Europe, have not been consulted on a study that aims to assess the impact on the concerned sectors. This incomprehensible omission increases our deep concern about the Commission’s approach, which disregards repeated calls and recommendations from the European Parliament and the Council of the European Union to ensure a comprehensive and transparent assessment, not just an updated study.

The concerns focus on several key points. A study limited to updating costs, correcting for inflation rates, does not constitute a proper sector assessment. It would fail to assess the broader consequences for the impacted sectors and their products. Moreover, the study seems to be conducted by the same body that carried out the original, flawed assessment, thus questioning its independence.

The Directive – which was adopted in 2024 – was based on considerable errors regarding toxic load allocation and underestimations regarding the implementation costs. This has resulted in unfairly singling out only two sectors and the companies involved facing significantly higher costs than originally forecast, impacting on both the competitiveness and sustainability of these sectors.

Concerns have also been publicly raised by Member States. France and Germany have called for the directive to be revised, and Italy has asked for a pause in implementation, while Poland has taken legal action against the Directive in the Court of Justice of the European Union.

The pharmaceutical sector urgently asks the European Commission to:

• Pause the implementation of the EPR scheme for quaternary treatment in the UWWTD
• Consult the concerned industries in a transparent manner
• Conduct proper impact assessments on toxic load and implementation costs
• Take all necessary measures to preserve patient access and supply of medicines and uphold a decision-making process that is based on reliable and transparent scientific evidence.