The High Court has declared that Ireland’s rules did not properly transpose an EU directive requiring information on veterinary medicines to be provided in Irish and English. It granted three declarations in a judicial review brought by Peadar Mac Fhlannchadha, a native Irish speaker from the Connemara Gaeltacht who uses veterinary medicines for his dog.
The judgment, delivered by Ní Raifeartaigh J on 11 June 2021, concerns Directive 2001/82. Irish regulations allowed required information on veterinary medicine packaging and leaflets to appear in English or Irish. The applicant argued that the directive’s references to the language or languages of the country where a product is marketed required both official languages in Ireland.
The court had earlier concluded that the relevant provisions had direct effect on the language requirement and that Ireland had failed to transpose the directive correctly. It then referred questions to the Court of Justice of the European Union (CJEU) about whether it could withhold relief because a replacement EU regulation was due to apply from 28 January 2022. The CJEU ruled that a national court could not refuse to declare the failure and the obligation to remedy it on that basis. It did not decide the direct-effect question.
After the CJEU judgment, the State asked the High Court to reconsider its earlier direct-effect conclusion, relying on comments made by the Advocate General. The High Court refused: it found no sufficient reason to reverse its prior conclusion. The State also argued that any declaration should be non-mandatory and that separation of powers limited the court’s authority to order changes. The court rejected that argument as a bar to the relief sought.
The court granted declarations that the applicable national legislation did not properly transpose Title V of the directive; that required information on the relevant packaging and leaflets for veterinary medicines marketed in Ireland must be in both Irish and English; and that the respondent must amend national law to ensure proper transposition.
The court said it was not pleased to reach a conclusion that could have practical consequences for Irish agricultural businesses, but considered it required by the directive and the CJEU’s guidance. It said the applicant had succeeded in the judicial review and proposed awarding costs to him, unless the respondent sought a different costs order in writing within 14 days. If it did, the court would schedule a short costs hearing.