A Galway company which manufactures sheep dips has brought High Court proceedings against the Irish Medicines Board which had found there was an unacceptable health risk to users of the dip because of the packaging system employed by the company.
Hygeia Chemical Ltd, Oranmore, Co Galway, is seeking by way of judicial review, orders quashing the decision of the board that the product be removed from the market.
The court has already granted a stay on the decision pending the outcome of the judicial review hearing before the president of the High Court, Mr Justice Finnegan.
Mr Eugene McCartan, Hygeia's managing director, in an affidavit claimed that not one adverse reaction had been reported in respect of the sheep dip and its use by an estimated 44,000 farmers in dipping many millions of sheep over the past five or six years.
Mr Pat O'Mahony, the chief executive of the Irish Medicines Board, in an affidavit said its decision to suspend authorisation for Hygeia's sheep dip last February was based on an unacceptable risk to users of the dip products which were packaged in an open delivery system - (i.e. a screw- cap container) which required the user to pour the concentrates into the sheep-dip bath.
The board wants the company to use a closed delivery system to reduce exposure to the risk of concentrate dripping down the side of the packet and the risk of inhalation of vapour.
The board says it concluded there was an unacceptable health risk from exposure to organophosphate sheep-dip products supplied by the open delivery system. It also claims it adopted procedures which were sufficient to allow Hygeia to present its case.
Hygeia is challenging the Irish Medicines Board's decision on the grounds that it was denied fair procedures and natural justice because of the way it arrived at its decision. It is also alleges the decision is tainted by bias.
Mr McCartan alleges in his affidavit that in reaching its decision, the medicines board relied on material that had never been furnished to Hygeia. Hygeia did not believe the board could act on the presumption that farmers would use the product other than in accordance with instructions on the label for use.
The hearing continues today.