The High Court has asked the Court of Justice of the European Union to rule on the validity of new EU wastewater rules requiring pharmaceutical and cosmetics producers to fund at least 80% of the cost of removing micropollutants.
Mr Justice Humphreys referred the issue on May 20 in proceedings brought by the Irish Pharmaceutical Healthcare Association and Medicines for Ireland against the State.
The dispute concerns Directive 2024/3019 on urban wastewater treatment. It requires Member States to progressively introduce an additional stage known as quaternary treatment to remove micropollutants. Producers of human medicines and cosmetics must fund at least 80% of relevant costs through an extended producer responsibility scheme.
The industry groups argue that the scheme may breach EU principles including proportionality, equal treatment, non-discrimination, legal certainty and the polluter-pays principle. They also contend that the scientific basis for allocating most of the cost to the pharmaceutical and cosmetics sectors is flawed and that the measure could affect medicine availability and affordability.
The State disputes the claim that the directive is invalid but has left detailed defence of the EU legislation primarily to the EU institutions.
The High Court did not decide whether the industry groups’ criticisms are correct. Instead, it found that the validity questions should be determined by the CJEU before the domestic challenge proceeds.
The question referred includes whether the directive is invalid because other micropollutant producers are excluded from the 80% funding threshold, because all human medicines are included, because medicines and cosmetics are not treated as separate sectors, and because of alleged flaws in the underlying cost and pollution assessments.
The court also asked the CJEU to give the case priority. The directive must be transposed by July 31, 2027, while the relevant producer-funding obligations are intended to apply from the end of 2028.
The Irish proceedings are adjourned pending the European court’s judgment.