What changed

B100280/2026

B100243/2026

European Parliament resolution on the implementation of the Urbanurban Wastewaterwastewater Treatmenttreatment Directivedirective (UWWTD) and risks to the security of supply of medicines

(2026/2652(RSP))

– having regard to Article 191 of the Treaty on the Functioning of the European Union,

The European Parliament,

– having regard to DirectiveArticles (EU)168 2024/3019and 191 of the European Parliament andTreaty ofon the CouncilFunctioning of 27 November 2024 concerning urban wastewater treatment (Urbanthe WastewaterEuropean TreatmentUnion Directive),(TFEU),

– having regard to the Commission proposal of 11 March 2025 for a regulation of the European Parliament and of the Council laying a framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and accessibility of, medicinal products of common interest, and amending Regulation (EU) 2024/795 (COM(2025)0102),

– having regard to Council Directive 91/271/EEC of 21 May 1991 concerning urban waste-water treatment and its revision, Directive (EU) 2024/3019 of the European Parliament and of the Council of 27 November 2024 concerning urban wastewater treatment (recast),

– having regard to the work of the Critical Medicines Alliance, in particular its recommendations on strengthening the resilience of supply chains for essential medicines,

– having regard to the principles of subsidiarity and proportionality,

– having regard to the Commission communicationrole of 29the JanuaryMember 2025States entitledin ‘Aprotecting Competitivenesspublic Compasshealth forand the EU’ (COM(2025)0030),environment,

– having regard to the shared competences of the European Parliament’s Committee on the Environment, Climate and Food Safety and the Committee on Public Health,

– having regard to the question to the Commission on the implementation of the Urban Wastewater Treatment Directive and risks to the security of supply of medicines (O-000013/2026 – B10-0008/2026),

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

A. whereas the Urban Wastewater Treatment Directive (UWWTD) aims toeffective protecttreatment humanof healthurban andwastewater theis environmentessential fromfor the adverse effectsprotection of untreated urban wastewater, includinghuman throughhealth, thewater removalquality ofand micropollutants;ecosystems;

B. whereas Articles 9 and 10 of the UWWTD introduce an extended producer responsibility (EPR) scheme requiring the pharmaceutical and cosmetics sectors to cover at least 80 % of the costs of quaternary treatment for the removal of both micropollutants arising from products placed on the market and their residues;

B. whereas Member States face differing geographical, climatic and infrastructural conditions that have a significant impact on their wastewater management systems;

C. whereas, in accordance with the principle of proportionality, the allocation of costs under EPR schemes should be fair, proportionate and based on the respective contributions of different sectors to pollution, in order to avoid placing a disproportionate financial burden on certain industries;

C. whereas excessive regulatory burdens at EU level can increase costs for households and place disproportionate pressure on municipalities;

D. whereas the application of the UWWTD requires that costs be allocated in proportion to the actual contribution to pollution, taking into account that micropollutants originate from multiple sources that often cannot be attributed exclusively to specific industrial sectors, including the use of products by consumers;

D. whereas access to affordable water services is a central component of public health protection;

E. whereas cumulative regulatory and financial burdens, including those stemming from the UWWTD, risk undermining the EU’s competitiveness and attractiveness for cosmetics and pharmaceutical industries, as well as pharmaceutical innovation and investment, thereby affecting the development and timely availability of medicinal products;

E. whereas proposals to introduce extended producer responsibility schemes, including for the pharmaceutical sector, risk distorting healthcare systems and increasing costs for patients; whereas, in practice, such schemes are likely to shift costs to healthcare systems, patients and consumers rather than to producers;

F. whereas a disproportionate allocation of the costs of quaternary treatment to the pharmaceutical sector risks negatively affecting the availability and supply of medicinal products, potentially leading to market withdrawals, reduced competition and increased vulnerability of supply chains;

F. whereas, pursuant to Article 168(7) TFEU, the organisation and delivery of health services and medical care are the responsibility of the Member States, including decisions affecting the financing, pricing and availability of medicinal products;

G. whereas Case T-158/25 before the General Court of the European Union, which concerned the allocation of costs under the EPR scheme introduced by the UWWTD, was dismissed by order on grounds of inadmissibility for lack of legal standing, thereby leaving unresolved substantive questions relating to proportionality and cost allocation;

G. whereas uniform regulatory approaches at EU level risk disregarding local and regional knowledge, leading to inefficient allocation of resources and suboptimal infrastructure investment;

H. whereas Case C-193/25, currently pending before the Court of Justice of the European Union, raises questions on the interpretation of EU law concerning the application of the polluter-pays principle and the distribution of financial obligations under the UWWTD, the outcome of which may have implications for legal certainty and the uniform implementation of the framework across Member States;

H. whereas price distortions in the pharmaceutical market, including for generic medicines, may weaken competition, reduce security of supply and increase long-term healthcare costs;

I. whereas taxpayers and water users should not bear the financial burden of quaternary treatment, and such costs must be allocated in a fair, proportionate and non-discriminatory manner;

I. whereas the principle of proportionality requires that regulatory measures do not exceed what is necessary to achieve environmental objectives and that their economic and social consequences be taken into account;

1. Expresses concerns regarding the current EPR system, which places a disproportionate financial burden on certain sectors, particularly the pharmaceutical and cosmetics industries; warns that this system risks undermining the supply, availability and affordability of medicinal and cosmetics products;

1. Reaffirms that water policy and urban wastewater management must respect the competences of the Member States; recalls that, while EU action in the field of environmental protection may in principle be justified, Article 168(7) TFEU requires that such action must not encroach upon Member States’ responsibilities, in particular as regards the organisation, financing and cost structures of their healthcare systems, including indirectly through rules affecting the availability and affordability of medicinal products, and that any EU action must remain strictly limited by the principles of subsidiarity and proportionality;

2. Underlines that available industry data suggests that the additional costs for the cosmetic and pharmaceutical sectors may have been significantly underestimated;

2. Emphasises that any revision of EU rules must allow for maximum flexibility in implementation, taking account of national and local circumstances;

3. Stresses the importance of respecting the principle of subsidiarity by ensuring that Member States retain sufficient flexibility to determine and implement the most efficient and sustainable wastewater management solutions;

3. Stresses that environmental objectives must be pursued in a manner that ensures the affordability of water services and avoids excessive costs for households; warns that cost-shifting mechanisms that obscure the true origin of costs undermine efficient price signals, weaken cost transparency for consumers and public authorities, and lead to a misallocation of resources;

4. Calls on the Commission to carry out a new comprehensive and independent impact assessment that reflects the principles of proportionality and of non-discrimination, including a more accurate estimation of sectoral contributions to micropollutants;

4. Warns against imposing uniform EU-wide requirements that fail to take account of regional diversity and differences in infrastructure and thereby reduce the efficiency of resource allocation and long-term investment decisions;

5. Calls on the Commission to ensure that the implementation of the UWWTD does not undermine the availability, affordability and supply security of medicinal products within the EU, as well as the development and timely availability of medicinal products;

5. Emphasises that local and regional authorities are best placed to assess infrastructure needs and suitable technological solutions, and that centralised regulatory prescriptions risk disregarding context-specific knowledge and increasing inefficiencies;

6. Calls, therefore, on the Commission to suspend the application of Articles 9 and 10 of the UWWTD (‘stop the clock’), and to present, following a comprehensive impact assessment and taking into account the need for a balanced approach, a proposal to amend this directive as regards those provisions;

6. Rejects extended producer responsibility for medicinal products; notes that such schemes may in practice function as de facto levies on essential healthcare products, distort competition and ultimately increase costs for patients and public healthcare systems;

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

7. Calls for generic medicines to be exempted from such rules, in recognition of their crucial role in ensuring competition, cost containment and security of supply in healthcare systems;

8. Emphasises that the pharmaceutical industry should not be subject to sector-wide extended producer responsibility in the absence of a direct and demonstrable causal link to pollution, and that any targeted obligation must remain proportionate and must not undermine the availability, affordability or competitive functioning of the medicines market;

9. Warns that extended producer responsibility schemes introduced at EU level may in practice operate as hidden cost-shifting mechanisms, since costs imposed on producers are likely to be passed on to consumers through higher prices for essential goods and services; stresses that such increases may bypass national budgetary scrutiny and disproportionately affect low-income households;

10. Emphasises that the costs of urban wastewater treatment should, where necessary, be addressed through transparent and democratically accountable public financing mechanisms at Member State level, rather than through indirect regulatory cost-shifting at EU level that obscures who ultimately bears the burden;

11. Calls on the Commission to revise its proposal for a directive on the treatment of urban wastewater so as to remove extended producer responsibility provisions for medicinal products; considers that, where such provisions are maintained for other sectors, they must remain strictly limited, proportionate and cost-effective, fully respect the competences of the Member States, and avoid creating indirect cost burdens for consumers;

12. Emphasises the importance of investment in infrastructure and innovation, while stressing that Member States must retain the possibility to determine the most suitable technological solutions themselves; notes that innovation is best fostered through flexible, decentralised decision-making rather than prescriptive regulatory frameworks;

13. Opposes any further centralisation of water policy and calls for decision-making to remain as close as possible to citizens, with a strengthened role for local and regional authorities, in line with Article 5 of the Treaty on European Union;

14. Calls on the Commission to assess systematically the full economic impact of any proposed rules on urban wastewater, including cumulative compliance costs, before introducing new obligations;

15. Calls on the Commission to act as a supporting and coordinating body, strictly within the limits of the Treaties and without extending its role into areas reserved for the Member States;

16. Instructs its President to forward this resolution to the Council and the Commission.