Official Journal of the European Union

C series

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C/2025/2674

19.5.2025

(Case T-158/25)

(C/2025/2674)

Language of the case: English

Parties

Applicant: Fédération européenne d’associations et d’industries pharmaceutiques (EFPIA) (Luxembourg, Luxembourg) (represented by: C. García Molyneux, Z. Bertrand, lawyers, and B. Kelly, solicitor)

Defendant: 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 five pleas in law.

1.First plea in law, alleging manifest error of assessment. The financial obligations that Article 9 of Directive (EU) 2024/3019 imposes on producers of human medicines rely on a flawed study and a Commission impact assessment that overestimate the contribution of human medicines to micropollution and underestimate the costs of the Directive’s required quaternary treatment.

2.Second plea in law, alleging the infringement of the polluter-pays principle, as enshrined in Article 191(2) of the Treaty on the Functioning of the European Union, by the financial obligations that Article 9 of Directive (EU) 2024/3019 imposes on producers of human medicines. These obligations require producers of human medicines to finance the costs of quaternary treatment to an extent that is not proportionate to the actual contribution of their products to urban wastewater micropollution.

3.Third plea in law, alleging the infringement of the principle of proportionality as enshrined in Article 5(4) of the Treaty on European Union. The obligations that Article 9 of Directive (EU) 2024/3019 imposes on producers of human medicines are neither appropriate nor necessary to achieve the Directive’s objectives.

4.Fourth plea, alleging the infringement of the principle of non-discrimination as enshrined in Articles 20 and 21 of the Charter of Fundamental Rights of the European Union. Without justification, Article 9 of Directive (EU) 2024/3019 makes producers of human medicines and cosmetics pay for the micropollution of urban wastewaters caused by all other sectors.

5.Fifth plea, alleging the infringement of the requirement for legal certainty. Article 9 of Directive (EU) 2024/3019 imposes unforeseeable costs on producers of human medicines, including retroactive charges predating the Directive’s adoption.

(1) OJ 2024 L 3019.

ELI: http://data.europa.eu/eli/C/2025/2674/oj

ISSN 1977-091X (electronic edition)

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