The Supreme Court handed down judgment in the case of Hygeia Chemicals Ltd v Irish Medicines Board [2010] IESC 4 on 27th January 2010. The case concerned an appeal from the judgment of the High Court, upon the hearing of a claim for judicial review. The appellants who are manufacturers of products for veterinary use, initially applied for the judicial review of a decision taken by the Advisory Committee for Veterinary Medicines (ACVM), which assists the respondents in relation to matters pertaining to the safety and quality of medicinal products for animal use.

Following a report undertaken by the Committee on the Toxicity of Chemicals in Food, Consumer Products and the Environment in November 2002, concerns were raised that exposure to organophosphate (OP) could have an adverse effect on human health. As result the ACVM wrote to the appellants in November 2001 suspending the veterinary product authorisations for Hygeia Summer Dip and Hygeia Winter Dip on the basis that only approved closed delivery systems for transferring organophosphates from the container to the dip bath were acceptable for the protection of public health.

The appellants initially sought to appeal the decision to the ACVM and concerns were raised during lengthy communications over details of the appeal process. After the appeal procedure took place the appellant’s were notified that the appeal had been rejected in full and an unsuccessful claim for judicial review followed.

The Supreme Court, allowing the appeal, held that the judge had erred in law in finding that the procedures followed by the respondents and the ACVM were adequate and sufficient to meet the requirements of natural and constitutional justice. In the absence of by-laws or any clear procedural rules applicable to the review, unfair procedures had been adopted, which had had a detrimental effect on the appellant’s ability to deal with the appropriate appeals process. The fact that a wholly unclear criteria had been adopted, absent of any objective standards meant that the legal requirement that a party should know the precise case made against it had not been met. The court also indicated that placing a 20-30 minute time limit on the appellant’s submissions was a wholly inappropriate practice to adopt and applied to an “entirely different, open, full and transparent procedure”.

The court further went on to hold that the respondents had not complied with the conditions applicable to the precautionary principle in the context of withdrawal of a marketing authorisation. Under Directive 2001/82/ EC, although institutions may take protective measures without having to wait for the risks to human health to become fully apparent the withdrawal must be based on a scientific assessment of the risks. Following the case of Artegodan GmbH and Others v Commission of the European Communities mere changes of consensus or clinical practice cannot justify the withdrawal of authorisation on their own, if the change is not based on scientific data.