Case C-614/26, Irish Pharmaceutical Healthcare Association – who pays to take medicines out of wastewater
The Union decided in 2024 that the cost of removing residues of medicines and cosmetics from wastewater should fall mainly on the companies that sell them. That decision is now challenged in Luxembourg from two directions at once.
Facts
Directive (EU) 2024/3019, the recast Urban Wastewater Treatment Directive, adds a quaternary treatment stage, to remove micropollutants, in certain agglomerations. Article 9(1) requires Member States to ensure that, by 31 December 2028, producers who place any of the products listed in Annex III on the market have extended producer responsibility, covering “at least 80 % of the full costs” of that treatment and of the related monitoring. Annex III lists two product groups: medicinal products for human use and cosmetic products. Producers exercise that responsibility collectively, through organisations meeting the requirements of Article 10. Two Irish industry bodies, the Irish Pharmaceutical Healthcare Association and Alliance of Medicines for Ireland, brought proceedings in the High Court against the Minister for Housing, Local Government and Heritage, Ireland and the Attorney General. By a judgment of 20 May 2026 ([2026] IEHC 310) the High Court decided to ask the Court of Justice whether Articles 9 and 10 and Annex III are valid, setting out six possible grounds of invalidity.
Question Referred
1. Are Articles 9 and/or 10 of, and/or Annex III to, Directive 2024/3019 invalid, read in the light of Article 168 and/or the polluter pays principle under Article 191(2) TFEU and/or general principles of EU law including proportionality, equal treatment, non-discrimination, and/or legal certainty, and/or vitiated by manifest error, by reason of any one or more of the following:
(a) the exclusion of other producers of micropollutants not listed in Annex III to the directive from the minimum 80 % allocation threshold;
(b) the inclusion of all human pharmaceutical products in Annex III to the directive having regard in particular to the effects on accessibility, availability and affordability of medicines;
(c) the fact that neither Article 9 nor Article 10 of the directive require Member States to distinguish between producers of human medicines and cosmetic products when they transpose EPR [extended producer responsibility] obligations into their national laws despite the importance of human health pursuant to Article 168 TFEU and/or the fact that the pharmaceutical sector possesses unique characteristics that clearly distinguish it from the cosmetics sector and which will result in the financial obligations of the directive having a significantly different impact on the pharmaceutical sector;
(d) the fact that due to regulatory requirements and lead-in times for substitution of products, Article 9(1) of the directive will apply to micropollutants from 31 December 2028 notwithstanding that in practice it will be impracticable for most producers of pharmaceutical products to substitute constituents of such products by that date;
(e) the alleged significant underestimation of the annual costs of quaternary treatment and the impact of Article 9 of the directive on the affordability and accessibility of human medicines; and/or
(f) the alleged insufficiency of rationale and justifications in the directive for the imposition of a minimum of 80 % of the annual cost of quaternary treatment on producers of pharmaceutical and cosmetic products and the alleged fundamental flaws in the Feasibility Report on which the imposition of those costs is based?
Sources
OJ notice C/2026/4575 (EUR‑Lex) · Case file on CURIA · Directive (EU) 2024/3019 · Opinion of AG Kokott in Poland v Parliament and Council, C‑193/25 (ECLI:EU:C:2026:688) · Cosmetics Europe v Parliament and Council, T‑169/25 (ECLI:EU:T:2026:137)
Comment
The question reaches the Court by the route left open after the direct one closed. On 18 February 2026 the General Court dismissed as inadmissible the annulment actions brought by pharmaceutical and cosmetics producers and their associations, among them EFPIA and Cosmetics Europe; appeals against one of those orders are pending (C‑411/26 P and C‑412/26 P). A national court cannot itself declare an EU act invalid, but it can ask the Court of Justice to do so, and that is what the High Court has done.
The more important parallel is Poland’s action for annulment (C‑193/25). It attacks Article 9(1) and Annex III on grounds that largely overlap with points (a), (e) and (f) of the Irish question: that charging only two sectors, when others also release micropollutants, breaches the polluter-pays principle and equal treatment, and that the costs are disproportionate and inadequately justified. On 3 September 2026 Advocate General Kokott proposed that the Court annul Article 9(1)(a) and Annex III. Her reason was narrow but decisive. The institutions had said nothing, in the legislative process or before the Court, about how the shares of the toxic load attributed to pharmaceuticals and cosmetics were calculated, and Poland had raised “reasonable doubts” about the underlying values which were never examined, so the assessment was “vitiated by a manifest error”. She did not conclude that the two sectors’ share had been overestimated, only that it had not been shown to be right.
Two things in the Irish question go beyond Poland’s case. The first is affordability: points (b) and (e) argue that putting the cost on all human medicines threatens their availability. The Advocate General rejected Poland’s version of that argument, pointing to recital 21, which records the legislature’s view that the effect on prices would be “marginal at Union level” and leaves the Member States to manage the remaining risk, including through the regulation of medicine prices. The second is the comparison with cosmetics in point (c): the directive treats two very different industries alike, and the High Court asks whether Article 168 TFEU on public health required a distinction. Point (d), on the 2028 deadline, is not among Poland’s pleas as published. The Advocate General herself suggested, as an alternative, that the Court stay Poland’s case and decide it together with this reference, which “permits a more in-depth examination of the same questions”.