Smith Kline & French Laboratories (Aust) Ltd v Secretary, Department of Community Services and Health

Smith Kline & French Laboratories (Aust) Ltd and the Secretary, Department of Community Services and Health were the parties before the High Court of Australia. The dispute concerned the validity of a notice issued by the Secretary under section 31(1) of the *Therapeutic Goods Act 1989* (Cth) requiring the company to recall a particular pharmaceutical product, 'Tagamet'. The company sought to challenge the lawfulness of this notice.

The primary legal issue before the High Court was whether the notice issued by the Secretary was invalid for failing to comply with the requirements of procedural fairness. Specifically, the court had to determine whether the company was entitled to be afforded an opportunity to make submissions before the Secretary made the decision to issue the recall notice.

Mason C.J. held that the notice was invalid. His Honour reasoned that the power to issue a recall notice under section 31(1) of the *Therapeutic Goods Act 1989* was a power that affected the rights and legitimate expectations of the manufacturer. Consequently, the principles of procedural fairness required that the company be given an opportunity to be heard before the decision to issue the notice was made. The Secretary's failure to provide such an opportunity rendered the notice invalid.