The High Court has refused Hygeia Chemicals Limited’s application for judicial review of the Irish Medicines Board’s decision to suspend the authorisations for its Hygeia Winter Dip and Hygeia Summer Dip products. The court found the Board was entitled to act on concerns about human exposure to organophosphate concentrates and that its decision was proportionate.
The judgment, delivered by Finnegan P. on 4 May 2005, concerned liquid sheep dips containing 10% diazinon. The products were supplied in plastic containers from which users poured the dip into a bath. The Board had required a closed delivery system, or a similar system aimed at reducing exposure, and its veterinary advisory committee concluded in December 2002 that the products in their existing form posed an unacceptable exposure risk. The Irish Medicines Board decided in February 2003 to suspend the authorisations and begin a recall. The company had obtained a stay before that decision.
Hygeia challenged the process and the Board’s decision on several grounds, including alleged unfair procedures, bias, improper consideration of competitors’ commercial interests, and the claim that the Board had relied on use without protective clothing. The court rejected those challenges. It found the company had not acquiesced in the appeal procedures because it had expressly objected and reserved its position. It also found no established prejudgment, and concluded that the evidence did not show the Board had taken competitors’ commercial interests into account.
The court said there had been no reported adverse human reactions to Hygeia’s products. However, it noted documented concerns about organophosphate exposure, including acute poisoning, and found the precautionary principle applied. The Board could consider risks arising under the authorised conditions of use; the court said the identified risks remained even when the product was used in accordance with those conditions. It held that the evidence supported the Board’s decision and that the court’s judicial-review role was not to rehear the scientific merits as an appeal.
The court also rejected the claims of manifest error and misuse of power, including the challenge to a practical test of the container and the criticism that the alternative of a system “or similar” had not been properly considered. It concluded Hygeia’s open container system was not similar to a closed system.
Finnegan P. refused the relief sought. The judgment did not itself settle whether the products should be withdrawn or set a timetable for doing so: the judge said counsel would be heard on the order to be made, including that question.