High Court refers preliminary ruling on Directive 2024/3019 validity to CJEU under Article 267 TFEU.

[2026] IEHC 310

THE HIGH COURT

PLANNING & ENVIRONMENT

[H.JR.2025.00001517]

BETWEEN

IRISH PHARMACEUTICAL HEALTHCARE ASSOCIATION LIMITED AND ALLIANCE OF

MEDICINES FOR IRELAND CLG (TRADING AS MEDICINES FOR IRELAND)

APPLICANTS

AND

THE MINISTER FOR HOUSING, LOCAL GOVERNMENT AND HERITAGE,

IRELAND AND THE ATTORNEY GENERAL

RESPONDENTS

JUDGMENT of Humphreys J. delivered on Wednesday 20 May 2026

Subject-matter of the dispute

1. This request for a preliminary ruling concerns the validity of Articles 9 and 10 of and Annex

III to Directive 2024/3019 concerning urban wastewater treatment (recast).

2. The request is being made in proceedings concerning a challenge to proposed domestic

transposition of the directive in Irish law.

3. The first named applicant is a company limited by guarantee, registered under Part 18 of

the Companies Act 2014 and represents the international research-based pharmaceutical industry

in Ireland.

4. The second named applicant is a company limited by guarantee, registered under Part 18 of

the Companies Act 2014 and represents manufacturers and suppliers of generic, biosimilar and value

added medicines in Ireland.

5. The respondents are the relevant State parties.

6. The proceedings were filed on 13 October 2025. Leave was granted by the High Court on

17 November 2025. The matter was heard on 12 May 2026.

7. The proceedings raise questions as to the validity of Directive 2024/3019. Core ground 1 of

the amended statement of grounds filed on 18 May 2026 contends that the State is not entitled to

transpose the directive due to its invalidity. Core grounds 4 to 9 set out the basis on which it is

contended that the directive is invalid. Core grounds 2, 3 and 10 have been deleted.

8. In those circumstances the referring court is staying the proceedings and referring the

questions below to the Court of Justice for a preliminary ruling.

Legal context

Relevant European Union law measures

9. The following provisions of the TFEU are relevant:

(i) Article 168(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

(ii) Article 191 TFEU concerning environmental policy.

10. The following provisions of Directive 2024/3019 (https://eur-lex.europa.eu/legal-

content/EN/TXT/?uri=CELEX%3A02024L3019-20241212) are relevant:

(i) Article 1 which refers to the polluter pays principle;

(ii) Article 2(14) defining quaternary treatment;

(iii) Article 8 on quaternary treatment;

(iv) Article 9 on extended producer responsibility;

(v) Article 10 on minimum requirements for producer responsibility organisations;

(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

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-a41d-

49029f9ba5d4/707bdc7e-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/2022-

10/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/2022-

10/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/1f2054a9-

8a9b-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.

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 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-commission-

approach-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:

(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).

(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).

(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/Ramboll-

Report_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

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 (§30-

31).

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/2023-06-

28_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:

(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

(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

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:

(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 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?

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.

33. 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.

34. 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.

35. 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

36. 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

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.