What changed

B100240/2026

B100278/2026

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))

– 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 Directive),

The European Parliament,

– having regard to Article 3(3) of the Treaty on theEuropean FunctioningUnion ofand theArticles European9, Union11, (TFEU),168, 173, 191 and in192 particularof Articlethe 191Treaty thereof,on the Functioning of the European Union,

– 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 Article 35 of the Charter of Fundamental Rights of the European Union,

– having regard to Directive (EU) 2026/8052024/3019 of the European Parliament and of the Council of 30 March 2026 amending Directive 2000/60/EC establishing a framework for Community action in the field of water policy,27 DirectiveNovember 2006/118/EC2024 onconcerning theurban protectionwastewater oftreatment groundwater(Urban againstWastewater pollutionTreatment andDirective), deteriorationwhich andentered Directiveinto 2008/105/ECforce on environmental quality standards in the field of1 waterJanuary policy,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),

– having regard to the Commission communications of 11 March 2019 entitled ‘European Union Strategic Approach to Pharmaceuticals in the Environment’ (COM(2019)0128), of 14 October 2020 entitled ‘Chemicals Strategy for Sustainability – Towards a Toxic-Free Environment’ (COM(2020)0667), 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), and of 4 June 2025 entitled ‘European Water Resilience Strategy’ (COM(2025)0280),

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

– having regard to the Commission staff working document impact assessment of 26 October 2022, accompanying the proposal for a directive of the European Parliament and of the Council concerning urban wastewater treatment (SWD(2022)0541),

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

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

– having regard to the orders of the General Court in Cases T-169/25 and T-158/25, as well as in Joined Cases T-156/25, T-157/25, T-159/25 to T-168/25, T-170/25 and T-171/25,

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

– having regard to the question to theongoing Commissionwork on the implementation of the Urban Wastewater Treatment Directive and risks to the security of supply of medicinesproposed (O-000013/2026Critical –Medicines B10-0008/2026),Act,

– 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),

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

A. whereas the TFEU lays down that EU policy on the environment should aim at a high level of protection, taking into account the diversity of situations in the various regions of the EU, and that it should 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;

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

B. whereas micropollutants, which are found in all kinds of water bodies and are detected in all EU waters, pose serious damaging effects on aquatic life and human health, even in low concentrations, and are linked to cancer and endocrine-disrupting effects, and contribute to the spread of antimicrobial resistance (AMR); whereas the World Health Organization declared AMR an urgent global health crisis that is projected to cause more deaths globally than cancer by 2050;

B. 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 %);

C. whereas micropollutants can cause risks such as bioaccumulation, toxicity and resistance to degradation; whereas removal of micropollutants from contaminated wastewater is required to avoid its hazardous effects on health and the environment;

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

D. whereas micropollutants in wastewater are not effectively removed by conventional wastewater treatment; whereas the recast Urban Wastewater Treatment Directive (UWWTD) therefore introduces the obligation of quaternary treatment of wastewater, which removes micropollutants, notably via ozonation and/or filtering with activated carbon or advanced techniques such as nano-filtration using membranes; whereas the recast UWWTD requires the systematic upgrade of quaternary treatment in large treatment plants serving over 150 000 people (i.e. in large cities, as these are hotspots for the release of micropollutants) and only requires the upgrade of smaller treatment plants (serving between 10 000 to 150 000 people) if they are in areas at risk, the location of which the Member States must designate by 2030;

D. 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);

E. whereas this additional quaternary treatment is essential to prevent serious environmental and public health concerns, notably in locations where downstream waters are used for bathing or for extracting and producing drinking water;

E. 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;

F. whereas the implementation of quaternary treatment will be 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, and full implementation will be achieved by December 2045;

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

G. whereas extended producer responsibility (EPR) aims to internalise environmental externalities and should provide an incentive for producers to take into account environmental considerations along the life cycle of products, from design to end-of-life, effectively implementing the ‘polluter pays’ principle set out in Article 191 TFEU;

G. 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;

H. whereas the Organisation for Economic Co-operation and Development (OECD), in its work and policy guidance on EPR, has identified EPR as a key tool for shifting environmental responsibility from municipalities and consumers to producers and promoting eco-design and sustainable product life cycles;

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

I. 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;

I. 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;

J. whereas Article 9 of the recast UWWTD therefore establishes an EPR system whereby producers responsible for the bulk of micropollutants in wastewater – pharmaceuticals and cosmetics – finance at least 80 % of wastewater quaternary treatment in accordance with the quantities and hazardousness of the products they place on the market;

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

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

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

L. whereas, according to the Commission impact assessment accompanying the proposal for a directive concerning urban wastewater treatment, the potential increase in the costs of products or the potential reduction in the profit margins of the industries placing products on the EU market resulting from the application of EPR would be marginal at EU level and would not endanger the affordability, availability or accessibility of those products on the EU market; whereas the Commission estimates that even in a scenario of full cost pass-through, the impact on medicine prices would amount to EUR 2.64-3.20 per person per year by 2045; whereas this estimate was reconfirmed by a second study into the subject from the JRC, entitled ‘Updated estimation of the costs of quaternary wastewater treatment in the EU’ and published in December 2025, which took into account the final text adopted by the co-legislators;

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

M. whereas there is no evidence to suggest that EPR under the recast UWWTD will lead to medicine shortages or hamper the access, availability or affordability of medicines;

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

N. whereas the orders of the General Court in Cases T-169/25 and T-158/25, as well as in Joined Cases T-156/25, T-157/25, T-159/25 to T-168/25, T-170/25 and T-171/25, dismissed actions brought by industry against the EPR provisions of Directive (EU) 2024/3019 as inadmissible for lack of individual concern, thereby confirming that such legal challenges do not suspend or affect the implementation of the directive;

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

O. whereas the recast UWWTD explicitly states that Member States should take into consideration the possible impacts of the application of the requirements of EPR on the accessibility, availability and affordability of medicines, as well as the possible impacts of the application of those requirements on the level playing field; whereas the recast UWWTD allows Member States to take proportionate measures and utilise flexibilities to ensure that EPR obligations do not compromise the availability and affordability of essential medicines, including generic medicines;

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

P. whereas the recast UWWTD provides for the monitoring of its impacts on medicine prices and of any wider effects and requires the Commission to carry out a comprehensive evaluation of the directive by 31 December 2033 and again by 31 December 2040 under Article 30 thereof, providing a legal basis to assess real-world effects and, if necessary, propose adjustments;

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

Q. whereas the recast UWWTD provides significant flexibility to Member States in designing EPR schemes and calculating contributions, including mechanisms to ensure that contributions are proportionate and transparent;

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

R. whereas the phased deadlines under Article 8 of the recast UWWTD, requiring only 20 % coverage by the end of 2033, provide Member States with sufficient time to adjust the pricing of contracts for generic medicines through new tendering procedures with generic companies, to accommodate the additional estimated cost of EUR 0.53-0.64 per person per year in a scenario of full cost pass-through, thereby allowing the generics industry to absorb these costs while preserving significant profit margins;

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

S. whereas, even in a scenario of full cost pass-through, the resulting increase in the price of medicines remains marginal when compared to the cost of non-action, as the substantial long-term healthcare expenditure associated with diseases linked to micropollutant exposure, such as cancer and reproductive disorders, already impose a pointedly greater burden on public health systems and are expected to rise significantly;

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

T. whereas public health systems in the Member States are fully capable of adapting their reimbursement mechanisms in order to guarantee access to essential medicines;

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

U. whereas the obligation applies uniformly to all companies placing products on the EU market, whether produced inside or outside the EU, ensuring a level playing field and preventing unfair competitive advantages;

5. Questions the robustness of the methodology used to attribute pollution loads and allocate costs across sectors;

V. whereas the recast UWWTD obliges the Commission, on the basis of the results of urban wastewater monitoring and the most recent scientific data, to regularly evaluate whether other products should be included in the EPR system;

6. Notes that existing assessments fail to adequately address the impact on the availability of medicines, particularly generic and offpatent medicines;

W. whereas the recast UWWTD was adopted with overwhelming majorities by the co-legislators, demonstrating broad political support and democratic legitimacy;

7. Warns that the current design of the EPR scheme risks increasing medicine prices, reducing the availability of essential medicines and accelerating the relocation of production outside the EU;

X. whereas the ‘polluter pays’ principle is a necessary cornerstone of EU environmental law, ensuring that those responsible for causing and profiting from pollution are also those required to cover the costs of the damage it causes; whereas the ‘polluter pays’ principle must not be weakened as a result of political or industrial pressure;

8. Stresses that medicine shortages are already a major and growing challenge in the EU;

Y. whereas any delay, weakening or removal of EPR as regards the treatment of urban wastewater would shift billions of euro in costs onto municipalities, businesses and citizens, exacerbating social inequalities and placing an unfair burden on households, including the most vulnerable, and would seriously hamper the necessary efforts to prevent pollution from harmful micropollutants;

9. Highlights the need to safeguard EU pharmaceutical manufacturing capacity and supply chain resilience;

Z. whereas any delay, weakening or removal of EPR would also create legal and financial uncertainty, notably for drinking water operators, and would risk delaying urgently needed investments in wastewater infrastructure, thereby undermining environmental and public health objectives;

10. Calls on the Commission to carry out a new, comprehensive, independent and methodologically robust impact assessment covering the real costs of quaternary treatment, the sector-specific impact on pharmaceuticals (particularly on generic and offpatent medicines), a reassessment of the attribution of pollution, and the effects on medicine availability and affordability;

AA. whereas the new environmental quality standards, in particular the nine pharmaceutical environmental quality standards under the Water Framework Directive, cannot be achieved without advanced and additional water treatment; whereas even a ‘stop-the-clock’ approach under the UWWTD would not remove the obligation for Member States to implement the quaternary treatment required to comply with the Water Framework Directive’s environmental quality standards, albeit without the necessary funding;

11. Invites the Commission to reassess the scientific basis for the allocation of costs and ensure proportionality;

AB. whereas quaternary treatment is more costly per m³ in smaller urban wastewater treatment plants compared to larger-scale facilities; whereas this is likely to disproportionately disadvantage rural areas, with local businesses and farmers bearing a greater burden if the EPR scheme were to be abolished;

12. Calls for the temporary suspension (‘stop-the-clock’) of quaternary treatment obligations and EPR provisions for a period of two years, and until the new impact assessment has been completed;

1. Underlines the need to better protect human health and the environment, as part of an ambitious approach to tackling pollution from all sources, and to move towards a toxic-free environment, notably by tackling pollution of hazardous micropollutants, which present a considerable and acute threat to health and the environment;

13. Requests that the Commission submit a legislative proposal to implement this suspension;

2. Recalls that environmental policy should 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;

14. Calls on the Commission to clarify how non-EU producers will comply with EPR obligations, in order to avoid competitive distortions;

3. Reaffirms its clear support for the full, timely and ambitious implementation of the recast UWWTD, including the timely and correct implementation of an effective EPR system, in order to provide an effective and fair foundation for the ‘polluter pays’ principle and to ensure sufficient funds for the necessary treatment of urban wastewater;

15. Stresses the need for a level playing field between EU and non-EU manufacturers;

4. Denounces any and all opportunistic and unsubstantiated efforts by ‘Big Pharma’ and the cosmetics industry to delay, weaken or suspend the application of the ‘polluter pays’ principle; rejects any false claims about the impacts of EPR on the accessibility, availability and affordability of medicines;

16. Supports a substance-based and proportionate approach to cost allocation;

5. Warns that shifting costs from the polluters to municipalities would lead to significant increases in water tariffs, disproportionately driving up costs for all water users, notably including vulnerable citizens, farmers and small businesses;

17. Calls for the exploration of alternative or complementary financing mechanisms involving all relevant pollution sources, including wastewater operators;

6. Warns that failure to ensure the environmental protection of drinking water risks shifting a substantial financial burden on to future generations;

18. Calls for the establishment of a permanent multi-stakeholder platform involving representatives from industry, regulators and the public authorities;

7. Recalls that, under the Water Framework Directive, Member States are required to comply with environmental quality standards, including nine standards for pharmaceuticals, and warns that the abolition of the EPR scheme would result in a lack of adequate financial resources to comply with the standards;

19. Urges stronger coordination between environmental, health and industrial policies, including in Commission impact assessments;

8. Calls on the Commission and the Member States to uphold the integrity of the recast UWWTD in its entirety, and to ensure that all data used during its implementation is strictly evidence-based, transparent and free from undue industry influence;

20. Calls on the Commission to monitor the impact of EPR on medicine availability and report on this regularly;

9. Invites the Member States and the Commission to use the existing flexibilities under the UWWTD to address specific and duly justified concerns related to generic medicines, without undermining EPR;

21. Supports research and innovation in environmentally sustainable pharmaceuticals and advanced wastewater treatment technologies;

10. Recalls that in line with the One Health approach, the protection of human, animal and environmental health is intimately interlinked and entwined; underlines that access to medicines and environmental protection are not mutually exclusive and must be pursued simultaneously, without allowing one to be used as a pretext to weaken the other;

22. Emphasises that future measures must be science-based, technology-neutral and patient-centred;

11. Urges ‘Big Pharma’ and the chemical industry to stop pursuing their obstructionist, fact-free policies of diluting and delaying much-needed environmental measures, and to finally start contributing to a toxic-free environment, by embracing the EPR and by developing products that are safe and sustainable by design;

23. Instructs its President to forward this resolution to the Commission, the Council and the Member States.

12. Calls for a timely extension of the EPR system to other sources of micropollutants, including pesticides;

13. Instructs its President to forward this resolution to the Council, the Commission and the governments and parliaments of the Member States.