The Supreme Court allowed Hygeia Chemicals Limited’s appeal over the suspension of authorisations for its Winter Dip and Summer Dip sheep-dip products, finding that the Irish Medicines Board’s decision-making process involved unfair procedures and did not correctly apply the EU precautionary principle.
In a judgment delivered on 27 January 2010, Macken J. said the Board’s review process lacked clear, accessible rules. The Board had described a stage before its Advisory Committee for Veterinary Medicines (ACVM) as an “appeal”, but later disputed that an appeal existed. The Court held that, whatever the process was called, the stage created by the Board had to meet the requirements of constitutional fairness.
The Court identified several procedural problems. Hygeia was not told clearly what standard its containers had to meet, while the Board’s correspondence initially referred to closed delivery systems “or similar”. The ACVM had already decided that only closed systems would be acceptable, but Hygeia learned of that change during the High Court proceedings. The Court also found that Hygeia had too little time to prepare for the ACVM hearing, and that an informal test conducted under the Board’s control was not adequately disclosed to the company.
The Court rejected the separate claims of subjective and objective bias. It upheld the High Court’s assessment that the evidence did not establish subjective prejudgment. On objective bias, it concluded that a properly informed reasonable person would not consider that the ACVM’s members were influenced against Hygeia by the Veterinary Director’s involvement.
The Court also addressed the precautionary principle. It said that protective action may be taken amid scientific uncertainty, but not on a purely hypothetical risk; the assessment must be based on the best available scientific information and be carried out as thoroughly as possible. It found that the Board had not materially complied with those requirements in the process concerning Hygeia’s products.
The ACVM’s December 2002 letter had directed Hygeia to stop supplying the products and to recall stock from retailers before 31 January 2003. The Supreme Court did not quash the Board’s decision. Hygeia had adopted a closed delivery system, and the Court considered that remitting the matter for a fresh decision was moot. It granted declarations that the process failed to guarantee constitutional justice and that the precautionary principle had not been correctly applied.
The Court set aside the High Court judgment and orders and remitted the proceedings for the High Court to hear argument on whether damages were legally available and, if so, their assessment. It expressed no view on either damages issue.