The High Court has declared that Irish law did not correctly transpose EU rules on language requirements for veterinary medicinal products and that the State must amend national law to comply. The declarations concern products placed on the Irish market and require specified packaging and leaflet particulars in both Irish and English.
The applicant, a native Irish speaker who lives in the Connemara Gaeltacht and uses veterinary products for his dog, challenged Irish regulations that allowed the required information to appear in English or Irish. He argued that Directive 2001/82 required information in both official languages. The State disputed that reading, arguing that the directive was ambiguous and that Ireland could choose to permit one language. It also warned of potential effects on product availability, animal and public health, and agribusiness.
In an oral ruling in July 2016, the High Court concluded that the directive’s language provisions were clear, unconditional and directly effective on this issue. The judge considered that the wording required both languages where a Member State had more than one official language. The court later referred questions to the Court of Justice of the European Union (CJEU) about whether relief could be refused because a replacement EU regulation was due to apply from January 2022.
The CJEU ruled in March 2021 that a national court could not refuse to declare that the directive had been incorrectly transposed on the ground that the replacement regulation would later permit the national approach. The High Court then declined the State’s request to revisit its earlier conclusion on direct effect. It said the CJEU had not ruled on that issue, and the Advocate General’s observations did not give it sufficient reason to change its view.
The State also argued that the court could not require it to change the regulations. The High Court rejected that submission and granted all three declarations sought: that the applicable national legislation failed to transpose Title V of the directive correctly; that the relevant product information must be in both Irish and English; and that the respondent must amend national law to ensure correct transposition.
The judgment records that the applicant succeeded in the judicial review. The judge proposed awarding costs to him unless the respondent indicated within 14 days that it wished to argue for another costs order, in which case a short hearing would be scheduled. The judgment does not state a final costs order.