Changes from resolution motion to resolution motion joint

RemovedB100278/2026

European Parliament resolution on the implementation of the Urban Wastewater Treatment Directive (UWWTD) and risks to the security of supply of medicines

(2026/2652(RSP))

The European Parliament,

Changed– having regard to Article 3(3) of the Treaty on European Union andthe ArticlesFunctioning 9,of 11,the 168,European 173,Union 191(TFEU), and 192 of the Treaty onin theparticular FunctioningArticles of168 theand European191 Union,thereof,

– having regard to Article 35 of the Charter of Fundamental Rights of the European Union,

Changed– having regard to Directive (EU) 2024/3019 of the European Parliament and of the Council of 27 November 2024 concerning urban wastewater treatment (Urban Wastewater Treatment(revised Directive),UWWTD), which entered into force on 1 January 2025,

– having regard to Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy (Water Framework Directive),

Removed– having regard to its resolution of 7 May 2025 on the European Water Resilience Strategy,

Added– having regard to Directive 2006/118/EC of the European Parliament and of the Council of 12 December 2006 on the protection of groundwater against pollution and deterioration and Directive 2008/105/EC of the European Parliament and of the Council of 16 December 2008 on environmental quality standards in the field of water policy , amending and subsequently repealing Council Directives 82/176/EEC, 83/513/EEC, 84/156/EEC, 84/491/EEC, 86/280/EEC and amending Directive 2000/60/EC of the European Parliament and of the Council,

Added– having regard to Decision (EU) 2022/591 of the European Parliament and of the Council of 6 April 2022 on a General Union Environment Action Programme to 2030,

– having regard to its resolution of 17 September 2020 on the shortage of medicines – how to address an emerging problem,

Removed– having regard to the report of 10 December 2025 by the Commission’s Joint Research Centre entitled ‘Updated estimation of the costs of quaternary wastewater treatment in the EU’,

Added– having regard to the Commission staff working document of 26 October 2022 entitled ‘Impact Assessment, accompanying the Proposal for a Directive of the European Parliament and of the Council concerning urban wastewater treatment’ (SWD(2022)0541),

Removed– having regard to the Strategic Report of the Critical Medicines Alliance, published on 28 February 2025,

Added– having regard to the Commission communication of 12 May 2021 entitled ‘Pathway to a Healthy Planet for All – EU Action Plan: “Towards Zero Pollution for Air, Water and Soil”’ (COM(2021)0400),

Removed– having regard to the ongoing work on the proposed Critical Medicines Act,

Added– having regard to the report of the Joint Research Centre (JRC) of 10 December 2025 entitled ‘Updated estimation of the costs of quaternary wastewater treatment in the EU – A comparison of cost models’,

Removed– having regard to the question to the Commission the implementation of the Urban Wastewater Treatment Directive and risks to the security of supply of medicines (O-000013/2026 – B100008/2026),

Added– having regard to the ongoing work on the Critical Medicines Act,

Changed– having regard to Rules 142(5) and 136(2)136(4) of its Rules of Procedure,

Change 1

RemovedA. whereas the Urban Wastewater Treatment Directive aims to reduce water pollution, including via micropollutants, and protect water quality across the EU;

AddedA. whereas Article 191 TFEU lays down that EU policy on the environment ‘shall aim at a high level of protection taking into account the diversity of situations in the various regions of the Union’, and that it ‘shall be based on the precautionary principle and on the principles that preventive action should be taken, that environmental damage should as a priority be rectified at source and that the polluter should pay’;

RemovedB. whereas the directive introduces quaternary treatment and an Extended Producer Responsibility (EPR) scheme requiring the pharmaceutical and cosmetic sectors to finance a significant share of the cost of such treatment (at least 80 % and up to 100 %);

AddedB. whereas water is essential for life and humanity; whereas the EU must manage current and future water resources efficiently and respond effectively to the current water challenges, as they directly affect human health, the environment and its ecosystems, and strategic socio-economic activities;

RemovedC. whereas the introduction of quaternary treatment is the costliest feature of the directive;

AddedC. whereas micropollutants, which are found in all kinds of water bodies and are detected in all EU waters, have damaging effects on human health, including carcinogenic and endocrine-disrupting effects, and on aquatic life, even in low concentrations, and contribute to the spread of antimicrobial resistance (AMR); whereas the World Health Organization declared AMR as an urgent global health crisis that is projected to cause more deaths globally than cancer by 2050; whereas many micropollutants from medicinal products end up in the water after patient use rather than during production or disposal;

RemovedD. 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);

AddedD. whereas water pollution, including from micropollutants, poses a growing and severe threat to ecosystems, biodiversity and human and animal health and currently costs the EU over EUR 75 billion annually; whereas urban wastewater is one of the main sources of water pollution, if not properly collected and treated; whereas removal of micropollutants from contaminated wastewater is required to avoid its hazardous effects on health and the environment;

RemovedE. 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;

AddedE. whereas many municipalities and communities in the EU rely on bank filtration for their drinking water, resulting in water supplies that are increasingly contaminated with micropollutants;

RemovedF. whereas many micropollutants from medicinal products originate from patient use, rather than production or disposal;

AddedF. whereas costs for primary, secondary and tertiary treatment are generally covered by public bodies through taxpayer money or water charges; whereas the application to water treatment of the ‘polluter pays’ principle enshrined in Article 191 TFEU was first introduced in the revised UWWTD;

RemovedG. whereas the EPR scheme may have limited incentive effects in the pharmaceutical sector as a result of regulatory constraints on reformulation and patient safety considerations;

AddedG. whereas the UWWTD sets the legal framework for the collection, treatment and discharge of urban wastewater and the discharge of biodegradable wastewater from certain industrial sectors, whereas the revised UWWTD aims to reduce water pollution, including micropollutants, and protect water quality across the EU; whereas micropollutants in wastewater are not effectively removed by conventional wastewater treatment; whereas the revised directive introduces the obligation of quaternary treatment of wastewater, which removes micropollutants, thereby ensuring a high level of protection of health and the environment, in line with the One Health approach; whereas the revised directive requires the systematic upgrade to quaternary treatment of large treatment plants serving over 150 000 people (i.e. in large cities, as these are hotspots for the release of micropollutants) and requires smaller treatment plants to upgrade only if they are in risk areas;

RemovedH. whereas pharmaceutical manufacturers, particularly producers of generics, operate under strict pricing frameworks and with low margins, limiting their ability to absorb additional regulatory costs;

AddedH. whereas the implementation of quaternary treatment is gradual, starting in December 2033, at which point only 20 % of the larger plants and 10 % of the smaller plants will need to be upgraded, with full implementation to be achieved by December 2045; whereas the introduction of quaternary treatment as an additional and advanced treatment of urban wastewater in order to eliminate the broadest possible spectrum of micropollutants is needed to reduce these pollutants and protect public health and the environment; whereas the introduction of quaternary treatment represents the most costly component of the directive;

RemovedI. whereas generic and offpatent medicines account for nearly 70 % of medicines dispensed in the EU and are essential for healthcare system sustainability and national healthcare budgets;

AddedI. whereas the polluter pays principle is a legally binding principle enshrined in Article 191 TFEU, and aims to ensure that those responsible for causing environmental damage, and not taxpayers or the wider society, should pay for the costs of preventing, controlling and remedying that pollution;

RemovedJ. whereas medicine shortages in the EU have worsened in recent years and pose serious risks to patient care;

AddedJ. whereas Extended Producer Responsibility (EPR) aims at internalising environmental externalities and provides an incentive for producers to take into account environmental considerations along the life cycle of products, from design phase to end-of-life, effectively implementing the polluter pays principle; whereas most existing EPR schemes have been developed in the context of waste streams from identifiable point sources, where producers can effectively organise, monitor and control collection and treatment systems;

RemovedK. whereas the EU remains highly dependent on non-EU countries for active pharmaceutical ingredients;

AddedK. whereas medicinal products are developed and authorised with the objective of treating patients; whereas environmental risk assessments are a necessary criterion for the authorisation of medicinal products but the environmental risk does not form part of the benefit-risk evaluation in the authorisation of medicinal products;

RemovedL. whereas additional regulatory burdens risk accelerating the relocation of manufacturing to outside the EU, thereby undermining resilience and strategic autonomy;

AddedL. whereas data and analyses by the Commission and the JRC show that pharmaceuticals and cosmetics are the source of the highest share of potentially harmful and hard-to-biodegrade substances found in wastewater; whereas certain market authorisation holders report that the toxic loads attributed to certain products in these analyses differ from data from the environmental risk assessments of medicinal products;

RemovedM. whereas there is still uncertainty regarding how imported products will comply with and finance EPR obligations;

AddedM. whereas the revised UWWTD introduced EPR provisions in line with the polluter pays principle, which require that at least 80 % of the costs of quaternary treatment be covered by the main sectors identified as responsible for the release of the pollutants, namely the pharmaceutical and cosmetics industries;

RemovedN. whereas Member States and stakeholders have raised concerns about the proportionality, legal design and administrative burden of the EPR scheme;

AddedN. whereas EPR aims to finance the removal of micropollutants from wastewater and encourage the development of less toxic, more biodegradable products which are exempted from EPR; whereas the EPR system incentivises and rewards innovation in the development and use of less harmful substances in the sectors concerned;

RemovedO. whereas environmental legislation must remain proportionate, evidence-based and coherent with public health and industrial policy objectives;

AddedO. whereas access to safe, effective and affordable medicines is a cornerstone of EU public health systems, and the security of supply of medicines in the EU must be safeguarded;

RemovedP. whereas access to safe, effective and affordable medicines is a cornerstone of EU public health systems;

AddedP. whereas according to the Commission’s impact assessment and independent data, the potential increase in costs of products or the potential reduction of the profit margins of the industries placing products on the EU market resulting from the application of EPR would be marginal, and would not endanger the affordability, availability or accessibility of those products on the EU market;

Removed1. Reaffirms its strong support for the environmental objectives of the Urban Wastewater Treatment Directive and underlines the need to reduce water pollution;

AddedQ. whereas cost estimates by some Member State authorities exceed those provided in the Commission’s impact assessment (e.g. Germany and Spain have reported costs that are several times higher); whereas the Commission’s impact assessment has also been contested by certain stakeholders, notably as regards the environmental contribution of pharmaceuticals and cosmetics and the calculations of the effects on medicine prices; whereas the JRC carried out a second study with the aim of clarifying and further investigating the potential costs to be covered by industrial sectors affected by the directive; whereas this new study largely confirmed the previous data and findings;

Removed2. Stresses that environmental legislation must not undermine public health objectives, patient safety, or access to essential medicines;

AddedR. whereas generic medicines account for nearly 70 % of medicines dispensed in the EU and are essential for healthcare system sustainability; whereas manufacturers of generic medicines typically operate under strict pricing frameworks and on a high-volume, low-margin economic model, limiting their ability to absorb additional regulatory costs. and may therefore be more sensitive to increases in costs, requiring careful monitoring of the implementation of the directive;

Removed3. Underlines the importance of both the pharmaceutical and cosmetic industries for Europe’s competitiveness and resilience;

AddedS. whereas generic medicines are based on the same active ingredient as the reference medicinal product, which increases the challenge for generics manufacturers of addressing the pollution at source;

Removed4. Expresses deep concern that the cost estimates for quaternary treatment are significantly higher than initially projected;