2026 IEHC 310

(1)TFEU which requires that a high level of human health protection shall be ensured in the definition and implementation of all Union policies and activities; and (

1. ii)Article 191 TFEU concerning environmental policy. 10. The following provisions of Directive 2024/3019 (https://eur-lex.europa.eu/legalcontent/EN/TXT/?uri=CELEX%3A02024L3019-20241212) are relevant: (
2. i)Article 1 which refers to the polluter pays principle; (
3. ii)Article 2

(14)defining quaternary treatment; (iii) Article 8 on quaternary treatment; (

1. iv)Article 9 on extended producer responsibility; (
2. v)Article 10 on minimum requirements for producer responsibility organisations; (
3. vi)Article 33 requiring transposition by 31 July 2027; and (vii) Annex III defining the products to which Article 9 relates. Relevant domestic law measures 11. It is proposed to transpose the directive by regulations under the European Communities Act 1972 ((https://revisedacts.lawreform.ie/eli/1972/act/27/revised/en/html)). The State respondents have set out in correspondence some key elements regarding the nature of the proposed transposing measures. As a matter of domestic legal practice and procedure, the usual manner in which transposition is challenged is for an applicant to await the formal enactment of a specific transposing measure and then challenge the measure once adopted. However here the State parties have non-precedentially waived any objection to the proposed transposition being challenged in advance in this case, without prejudice to their right to make such objection in other cases. 12. Domestic caselaw acknowledges that in principle a challenge to the validity of an EU act “does not require that implementing measures have been adopted” and that the requirement to 2 refer a question in respect of the validity of an EU act must occur in the context of a genuine dispute capable of being litigated in domestic law which “could include any form of action capable of being domestically litigated, for example … where implementing measures are anticipated”: An Taisce v. Minister for Housing, Local Government and Heritage (No. 1) [2024] IEHC 129 (Unreported, High Court, 6 March 2024) (https://ww2.courts.ie/view/Judgments/328a9b27-42e9-45e6-a41d49029f9ba5d4/707bdc7e-46c3-48d5-b12b-68fe4f1dea40/2024_IEHC_129.pdf/pdf). Facts 13. On 26 October 2022, the European Commission published a Proposal for a Directive of the European Parliament and of the Council concerning urban wastewater treatment (recast) (https://environment.ec.europa.eu/system/files/202210/Proposal%20for%20a%20Directive%20concerning%20urban%20wastewater%20treatment%2 0%28recast%29.pdf). 14. Alongside the Proposal and its annexes, the Commission also published an impact assessment of the Proposal (https://environment.ec.europa.eu/system/files/202210/Impact%20assessment%20accompanying%20the%20proposal.pdf). The Impact Assessment stated that the feasibility and impacts of covering the additional costs for advanced treatment through a system of producer responsibility was assessed in the report entitled “Feasibility of an EPR system for micro-pollutants”

(2022)prepared by the Bio Innovation Services (https://circabc.europa.eu/ui/group/1c566741-ee2f-41e7-a915-7bd88bae7c03/library/1f2054a98a9b-4ea0-b32a-a063a4991e66/details?download=true). 15. The principal data used in the Feasibility Report was drawn from data compiled in a research paper prepared by the European Commission’s Joint Research Centre (“JRC”) entitled “European scale assessment of the potential of ozonation and activated carbon treatment to reduce micropollutant emissions with wastewater” (https://publications.jrc.ec.europa.eu/repository/handle/JRC128569). 16. Directive (EU) 2024/3019 of the European Parliament and of the Council of 27 November 2024 concerning urban wastewater treatment (recast), OJ L, 2024/3019, was published in the Official Journal of the European Union on 12 December 2024. The directive repeals and replaces Council Directive 91/271 of 21 May 1991 concerning urban wastewater treatment. It requires that for urban wastewater plants treating urban wastewater, Member States must progressively introduce an additional treatment, known as quaternary treatment, for the purpose of removing micropollutants. The directive obliges Member States to take measures to ensure that producers who place on the market human medicines and cosmetics cover at least 80% of the costs of complying with this requirement, through an extended producer responsibility (“EPR”) scheme. 17. By letter dated 15 April 2025, the applicants and BioPharmaChem Ireland jointly wrote to the first named respondent expressing concerns regarding the cost allocation method arising from the obligations under Article 9 of the directive. The letter posed a series of questions to the Minister in respect of the EPR scheme which he planned to introduce, including whether the directive would be transposed by primary or secondary legislation, whether the draft transposing legislation would be published and whether the State intended to expand the EPR scheme to product sectors other than medicines and cosmetics. The letter queried whether the Minister would consider undertaking independent testing of wastewater before attributing cost to just two sectors. The letter asked the Minister to consider testing urban wastewater to detect the source of all micropollutants before singling out only two sectors. 18. The first named respondent replied by letter dated 14 July 2025, stating that the directive would be transposed using secondary legislation and that extending the EPR scheme beyond the medicines and cosmetics sector was not being considered at this time. In relation to the issue of testing of wastewater, the Minister replied that “The parameters tested so far have been detected” and that “further testing may have to be undertaken to get a more complete picture of the chemical present in both wastewater treatment plants influent and effluent”. 19. The first named applicant wrote to the Minister on 22 September 2025, indicating its understanding that it was not intended to extend the EPR scheme to other sectors, that the directive would be transposed using secondary legislation and that no pre-implementation testing of water had been carried out for the purpose of clarifying the source of micropollutants. The letter claimed that the allocation of at least 80% of the costs of quaternary treatment to the pharmaceutical and cosmetic sectors meant that producers of such products would pay significantly more than the cost of removal of micropollutants resulting from their own products. The letter claimed that this was disproportionate, scientifically unjustified, contrary to the polluter pays principle, discriminatory and jeopardised the affordability and accessibility of medicines in the EU. The letter also claimed that the cost allocation was vitiated by manifest errors of assessment and violated the principle of legal certainty. The letter indicated the first named applicant’s intention to commence judicial review proceedings against the Minister’s alleged decisions and to seek a preliminary reference to the Court of Justice of the European Union in respect of the legality of the EPR provisions in the directive. 3 Factual context of introduction of EPR scheme 20. The Feasibility Report stated at page 12 that “The study specifications already identified pharmaceuticals for human use as one of the sectors to be covered by this study, given that the presence of pharmaceuticals residues is a known environmental problem. This has been highlighted in previous work conducted in the context of the Water Framework Directive, Environmental Quality Standards Directive and research publications.” (footnotes omitted) and that “The study defines the approach to identify a second sector (to start with) that would also contribute to the EPR scheme.” The Impact Assessment stated at page 58 that it was assumed that the scope of the EPR scheme would cover pharmaceuticals and personal care products. 21. At pages 48 to 49 of the Feasibility Report, it was claimed that pharmaceuticals and cosmetic products “…contribute to 92% of the toxic-weighted load based on the Potential No Effect concentration indicator.” In a European Commission Press Release dated 26 October 2022, it was claimed “92% [of] toxic micro-pollutants found in EU wastewaters come from pharmaceuticals and cosmetics ...” (https://ec.europa.eu/commission/presscorner/detail/en/qanda_22_6281). 22. The applicants have led affidavit evidence regarding fundamental flaws which they allege arise in the Impact Assessment and Feasibility Report. In their statement of opposition, the respondents plead that the Impact Assessment was scientifically robust (§11.5 of statement of opposition); however, the respondents do not adduce specific evidence, scientific or otherwise, in that regard, and plead that it is for the EU institutions to defend the validity of the directive (§34 of the statement of opposition). Accordingly, the affidavit evidence of the applicants set out below is neither contradicted nor accepted by the respondents. The parties agree that in circumstances where the factual context and affidavit evidence at issue concern facts necessary to assess the legality of the contested EU act, it is appropriate for this court to take account of the affidavit evidence and to refer to it in an order for reference (without making a finding on

1. it)for the purpose of determining that an arguable (or “well-founded”) case has been raised as to the validity of the directive. 23. A report for the European Federation of Pharmaceutical Industries and Associations (“EFPIA”) (https://www.efpia.eu/media/d3gd5agc/rsa-efp001-002-review-of-commissionapproach-to-allocating-toxic-load-to-pharmaceuticals-3-june-2025.pdf) concluded that “… major concerns about the quality and bias of some of the underlying data have been identified, which suggests that the calculated toxic load for pharmaceuticals has been greatly overestimated.” In particular, the views of the authors of the report were that: (
2. i)The Commission relied on ecotoxicity data contained in single paper when more reliable ecotoxicity data are publicly available from other data sources. The Commission’s approach is highly selective in terms of the data sources used (see p. 17 of Report and paragraph 5 of the affidavit of a lead author of the report sworn on behalf of the applicants on 9 October 2025). (
3. ii)The calculated toxic load for several pharmaceuticals has been greatly overestimated. Predicted No-Effect Concentrations (“PNECs”) derived using in-silico data are often several orders of magnitude lower than those derived from empirical data (see p. 5 of the Report and paragraph 5 of the affidavit). (iii) The use of market data for pharmaceuticals but not for other substances introduces significant bias in inflating toxic loads for pharmaceuticals in comparison to other substances. This is because market data (the quantity of pharmaceuticals consumed by patients) does not take into account any human metabolism or degradation and therefore represents a worst case. In contrast, use of measured effluent concentrations for other substances implicitly takes any removal processes into account (see pp. 4-5 and 15 of the Report and paragraph 5 of the affidavit). (
4. iv)A more rigorous assessment of sector allocation could potentially reduce apportionment of toxic load to human pharmaceuticals, for example through consideration of substances used in multiple industry sectors, substances which are also naturally occurring and substances derived from household vs. non-household settings (see p. 15 of the Report and paragraph 5 of the affidavit). 24. A report produced by Ramboll entitled “Micropollutants in urban wastewater: critical review of the Impact Assessment accompanying the EU Urban Wastewater Treatment Directive (UWWTD)” for certain pharmaceutical organisations in Germany (“Ramboll Report”) found that a literature search (https://www.medicinesforeurope.com/wp-content/uploads/2025/05/RambollReport_Micropollutants-in-Urban-Wastewater.pdf) identified a significant number of additional studies which had not been considered by the Commission. Ramboll also concluded that pharmaceuticals represent the best-studied group of micropollutants “which may give them an unrepresentatively large share in the allocation of pollution loads”. 25. A report produced by IQVIA for the EFPIA entitled “Literature review to understand the pharmaceutical contributions to micropollutant load and environmental risk” identified a high degree 4 of variability in the reported presence of pharmaceuticals and concluded that “there is a lack of conclusive evidence as to the contribution of pharmaceuticals towards micropollutant load and toxicity” and that “the results of the EPR Feasibility Report are not readily supported by current literature”. 26. In his affidavit, sworn on behalf of the applicants, on 2 March 2026, a professor of public policy reviewed (from an economic perspective) the Commission’s Impact Assessment, the Feasibility Report and an updated estimation of the costs of quaternary wastewater treatment set out in a report published by the Commission subsequent to the initiation of these proceedings (and the adoption of the directive). He stated that the Commission documentation does not demonstrate that pharmaceutical and cosmetic producers are responsible for approximately 80% or more of the cost of installing and operating quaternary wastewater treatment. He further stated that the treatment system is designed to clean the entire mixed wastewater stream and that its main costs depend largely on plant size and the total volume of wastewater treated, rather than solely on the share of pollution levels attributable to any one sector. In addition, he stated that requiring two sectors to fund most of the system, while other responsible sectors that contribute to micropollutants are not required to contribute in the same way, places a disproportionate financial burden on a narrow group, meaning that these other sectors benefit from the treatment system without bearing a comparable share of its cost. He averred that this weakens incentives for pollution reduction outside the charged sectors. He further averred that in pharmaceutical markets, where prices are often regulated and margins can be limited, additional financing burdens may not pass smoothly through prices but may instead affect margins, product availability, or public healthcare budgets (§302). 27. Insofar as a purpose of the EPR scheme is to incentivise the substitution of substances generating micro-pollution with greener substances (see Recitals 20 and 23), the applicants have led evidence that the pharmaceutical sector possesses unique characteristics which affect its ability to substitute substances. For example, in his affidavit, sworn on 13 October 2025 on behalf of the applicants, the CEO of the first named applicant sets out (at §§22-39) that the medicine development process (from identification of a candidate substance to market authorisation (“MA”)) is particularly lengthy with a high failure rate. It is estimated that the journey to market a human medicine, from the first identification of a promising candidate substance to being used by a patient, can span more than 15 years (§35). Once a medicine receives an MA, only certain changes to its composition are permitted. The replacing of an active pharmaceutical ingredient (“APIs”) with a new substance which has a different chemical profile requires an entirely new product development process, a new MA and new pricing negotiations (§36). 28. In his affidavit sworn on behalf of the applicants on 13 October 2025, the Director of Generic Medicines for the second named applicant has averred (at §47) that in many cases, it is not technically feasible to redesign the structure of APIs to eliminate or significantly reduce micropollutants. With regard to the significance of impact on the sector, he has averred that the EPR scheme will lead to shortages of critical medicines, severe supply disruptions of generic medicines and will compromise patient access to affordable and essential critical medicines (§3031). 29. The Impact Assessment assumed that the total EPR costs across all Member States of the European Union would amount to €1.185 billion for quaternary treatment and €11.2 million for related administrative costs. An Opinion Paper of the German Environment Agency (“GEA”), dated April 2023, entitled “Moving forward: The European Commission’s Proposal for a Recast Urban Wastewater Treatment Directive” (https://www.umweltbundesamt.de/system/files/medien/1410/publikationen/2023-0628_sciopap_recast-urban-wastewater-treatment-Directive_bf.pdf) considered that the methodology used by the Commission ignored a crucial aspect that impacts price, namely the increase of energy and construction prices which would greatly increase the estimate. The respondents do not accept that the Impact Assessment significantly underestimated the annual costs of quaternary treatment. They plead that the impact analysis was carried out in 2021/2022 whereas the GEA Report was published in 2023 and that differences in costing is attributable to intervening cost inflation. Agreed points of interpretation 30. The parties agreed that the directive should be interpreted as follows: (
5. i)Articles 9 and/or 10 of Directive 2024/3019 do not require Member States to distinguish between producers of human medicines and cosmetic products as such as opposed to distinguishing between different products by reason of their composition; and (
6. ii)Article 9

(3)(c) of Directive 2024/3019 does not have the effect of requiring a Member State to make a determination of the quantity of each relevant substance in the urban wastewater of the Member State concerned. The question for reference 5 31. The question is: 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: (

1. a)the exclusion of other producers of micropollutants not listed in Annex III to the directive from the minimum 80% allocation threshold; (
2. 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; (
3. 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 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; (
4. 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; (

1. 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 (
2. 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? 32. The applicants’ proposed answer is Yes, Articles 9 and 10 of and Annex III to Directive 2024/3019 are invalid in light of the polluter pays principle under Article 191

(2)TFEU, read in the light of general principles of EU law including proportionality, equal treatment, non-discrimination and legal certainty, and in circumstances where the directive is vitiated by manifest error.

1. The respondents’ proposed answer is No, Articles 9 and/or 10 of, and/or Annex III to, Directive 2024/3019 are not invalid, whether for the reasons identified or otherwise. Ultimately, it is a matter for the EU legislature to satisfy the CJEU of same.
2. The referring court’s position is that in view of the fact that the State respondents have not submitted either evidence or legal argument addressing the issues to which the question relates, other than by way of a general rejection of the claim of invalidity, on the basis that a detailed defence is more properly a matter for the EU legislature, the referring court is not in a position to give a particularly meaningful proposed answer, as this would ideally depend on evaluating, in due course, factual and/or legal responses to the applicants’ claim, when submitted by EU institutions, Member States and any other participants in proceedings before the CJEU. Should the CJEU have any different preference as to the expression of a preliminary view by a referring court in such a situation if it were to arise in any future case, the referring court would be glad to be guided in that regard if the opportunity to do so arises in the course of the judgment of the CJEU.
3. The relevance of the question is that if the answer is Yes, the referring court would grant the declaration sought in the amended statement of grounds to the effect that the State is not entitled to transpose the impugned provisions under the European Communities Act 1972 . Request for priority
4. The referring court respectfully requests that the case be given priority over other cases, pursuant to Article 53

(3)of the Rules of Procedure of the CJEU. The referring court is of the view that imperative considerations of public interest in the EU militate in favour of a ruling on the question being delivered in a shorter time than if the proceedings were to follow the normal course. The normal timeline for a ruling would run the risk of uncertainty as to the validity of provisions at issue as the transposition deadline of 31 July 2027 becomes more proximate. As well as the interests of environment and human health motivating the directive, arguments have been raised in these proceedings as to the impact on public health which might arise from the imposition of extended producer responsibility on the pharmaceutical sector. The potentially onerous requirement for quaternary treatment will require significant investment in infrastructure across the European Union 6 and the pharmaceutical sector will need to prepare to exercise their extended producer responsibility collectively through producer responsibility organisations, thus giving rise to a need to resolve any uncertainty as soon as practicable. Order 37. For the foregoing reasons, it is ordered that: (i) the question set out in this judgment be referred to the CJEU pursuant to Article 267 TFEU; (ii) the President of the CJEU be respectfully requested to afford such priority to the request over other cases as may be considered appropriate; and (iii) the substantive determination of the main proceedings be adjourned pending the judgment of the CJEU, without prejudice to the determination of any appropriate procedural or interlocutory issues in the meantime.