What changed

N. whereas the introduction of quaternary treatment is the costliest feature of the Directive;

O. whereas Member States’ cost estimates significantly exceed those provided in the Commission’s impact assessment (e.g. Germany and Spain have reported costs several times higher);

T. whereas the Commission’s attribution of approximately 92 % of the micropollutant load to pharmaceuticals and cosmetics has been questioned on methodological and scientific grounds, in particular given the lack of a thorough analysis of the consequences for patient access and national healthcare budgets; whereas this omission is especially critical for the entire pharmaceutical ecosystem, encompassing innovative, generic and off-patent medicines, which collectively underpins patient access, security of supply and the long-term sustainability of European healthcare systems, while sustaining the investment in research and development and the manufacturing footprint on which Europe’s strategic autonomy in health depends;

6. Calls on the Commission to produce a new independentimpact studyassessment by the end of 2026 identifying the list of substances present in urban wastewater, verifying the costs of quaternary treatment and the attribution of responsibility to the relevant sectors under the polluter pays principle, and identifying the potential impact on the availability, affordability and accessibility of medicines, in particular generic and critical medicines and their active substances; considers that the Member States, through the Human Pharmaceutical Committee, and the European Environment Agency and the European Medicines Agency should be appropriately involved in the study, within their areas of competence; calls on the Commission to accelerate, if necessary on the basis of the studyimpact assessment results, the evaluation of the allocation of substances, and also, if necessary, to immediately reattribute EPR obligations to the sectors identified as responsible; calls on the Commission to issue a communication by the end of July 2026 informing Member States about the independent study and the flexibilities under the directive to ensure the accessibility, availability and affordability of medicines, and to take the necessary measures to monitor the security of supply of medicines and crisis preparedness and avoid unintended consequences for the supply of medicines, including consequences arising from the EPR provisions; considers that, if the results of the studyimpact assessment demonstrate significant risk to the affordability, availability and accessibility of medicines, in particular critical and generic medicines, the Commission should swiftly adopt safeguards to guarantee the security of supply of these medicines;medicines, including a temporary suspension of EPR obligations;

7. Calls on the Commission to make progress on the adoption of implementing acts on the scope of obligations relating to quaternary treatment, to give clarity to the Member States, wastewater operators and relevant stakeholders with regard to the associated costs;

8. Recalls the gradual implementation timeline for the EPR and quaternary treatment obligations, with certain provisions not fully applying until 2045, which provides sufficient time for the gradual and balanced implementation of the directive and the quaternary treatment obligations, namely 20 % coverage by 2033, 60 % by 2039 and full coverage by 2045; recalls that the technical aspects of the EPR provisions and national EPR organisations can be adjusted at both EU and national level to ensure fairness and effectiveness; calls for both the Commission and the Member States to make full use of the directive’s existing provisions to ensure that evidence and appropriate and reliable data are fully taken into consideration in the implementation of the directive;

9. Calls for a temporary suspension (‘stop the clock’) of the EPR provisions and of the quaternary treatment obligations and related financial obligations until the completion of the study and the assessment of its findings by the Commission;