Official Journal of the European Union

C series

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C/2025/2672

19.5.2025

(Case T-156/25)

(C/2025/2672)

Language of the case: English

Parties

Applicant: Accord Healthcare France SAS (Lille, France) (represented by: T. Voland, U. Reese, M. Petite, P. Leven, L.-I. Dietz, M. Steininger and K. Schroeder-Finckh, lawyers)

Defendants: European Parliament, Council of the European Union

Form of order sought

The applicant claims that the Court should:

—declare null and void Article 1, Article 2(19), (20) and (26), Article 9, Article 10, Article 30(1) sub-paragraph 2(c) and (g) and Annex III of the Directive (EU) 2024/3019 of the European Parliament and of the Council of 27 November 2024 concerning urban wastewater treatment (‘UWWTD’) (<span class="oj-super oj-note-tag">1</span>);

—in the alternative declare these provisions null and void to the extent that they concern the applicant;

—in the alternative declare null and void the entire UWWTD; and,

—order the defendants to pay the costs of the proceedings.

Pleas in law and main arguments

In support of the action, the applicant relies on two pleas in law.

1.First plea in law, alleging an infringement of an essential procedural requirement.

—Articles 9 and 10 UWWTD were adopted on the basis of Article 192(1) TFEU. This is evidently wrong because these provisions create payment obligations and are therefore of a ‘primarily fiscal nature’. Rather, the correct legal basis would have been Article 192(2)(a) TFEU, which requires another legislative process than the one applied by the defendants in the present case, by an unanimous decision in the Council. As the defendants did not have discretion to choose the appropriate process and as two Member States voted against the adoption, applying the wrong legislative procedure renders Articles 9 and 10 in conjunction with Annex III void.

2.Second plea in law, alleging an infringement of the Treaties.

—Violation of Union policies: the application of the concept of an extended producer responsibility (‘EPR’) scheme to the producers of generic medicinal products runs counter the requirement of Article 168(1) TFEU and Article 35 of the Charter of Fundamental Rights of the European Union (‘Charter’) to ensure a high level of human health protection in the definition and implementation of all Union policies and activities and to ensure access to healthcare services.

—Manifest error of assessment: the Impact Assessment by the Commission, which forms the basis for the UWWTD, was significantly flawed and led to erroneous results and assumptions.

—Violation of the ‘polluter pays’ principle:

—the EPR scheme established by Articles 9 and 10 UWWTD is incompatible with and not covered by the ‘polluter pays’ principle, as it does not have a ‘steering effect’ and violates the principle of proportionality. In general, the allocation of costs for quaternary treatment will not encourage the development of ‘greener’ medicinal products. Since it is not technically feasible to redesign the structure of active pharmaceutical ingredients (‘APIs’) to eliminate or significantly reduce micropollutants linked to these APIs, a large number of key medicinal products (such as antibiotics or oncological medicines) cannot and will not exist if the chemical substances critical to their efficacy and safety would need to be removed.

—Moreover, the allocation of the costs of quaternary treatment under the UWWTD to the producers of medicinal products and cosmetic products violates the fundamental principle of proportionality and non-discrimination as recognized under Articles 2 and 5(4) TEU and the right to equal treatment as established under Article 20 Charter. The application of the established EPR scheme under the UWWTD leads to an arbitrary and unjustifiable discrimination of two selected industrial sectors by allocating at least 80 percent of the costs of quaternary treatment exclusively to the producers of medicinal products and cosmetic products, while even allowing Member States to increase this share up to 100 percent. It is evident and undisputed that micropollutants in urban wastewater are caused by a wide range of products from various sources and industries. As a result, under the UWWTD producers of medicinal products will be required to bear the costs of removing micropollutants that they have in fact not caused or generated and for which they have no responsibility, neither generally nor under the concept of EPR.

—Violation of fundamental rights: Articles 9 and 10 of the UWWTD infringe several fundamental rights, including the freedom to conduct a business, equality before the law, and freedom of association. The EPR scheme imposes significant costs on producers of medicinal products including the applicant, threatening their business model and violating their fundamental rights. The scheme lacks a legitimate objective, conflicts with the protection of human health, and is inappropriate and disproportionate. It unfairly burdens medicinal product producers compared to other polluters and industries, and forces them to join or contribute to a Producer Responsibility Organization, violating their freedom of association.

—Violation of the principle of legal certainty and predictability: Lastly, key aspects of the UWWTD are unclear, such as the number of wastewater treatment plants needing quaternary treatment and thus the costs to be expected. The cost burden calculation based on product quantities and hazardousness is also unspecified, and the interpretation of exemptions like ‘rapidly biodegradable’ is unclear. This lack of clarity violates legal certainty and proportionality, as the legislator cannot reliably assess the actual impact on producers.

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(1) OJ 2024 L 3019.

ELI: http://data.europa.eu/eli/C/2025/2672/oj

ISSN 1977-091X (electronic edition)

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