Australian Competition and Consumer Commission v Pfizer Australia Pty Ltd (ACN 008 422 348)

The Australian Competition and Consumer Commission (ACCC) brought proceedings against Pfizer Australia Pty Ltd (Pfizer) in the Federal Court of Australia concerning alleged contraventions of the *Therapeutic Goods Act 1989* (Cth) and the *Competition and Consumer Act 2010* (Cth). The dispute centred on Pfizer's conduct in relation to the supply of the drug Chantix, a smoking cessation aid.

The primary legal issues before the High Court of Australia were whether Pfizer engaged in misleading or deceptive conduct in contravention of section 18 of the *Australian Consumer Law* (Schedule 2 to the *Competition and Consumer Act 2010* (Cth)), and whether it contravened the *Therapeutic Goods Act 1989* (Cth) by advertising Chantix without regulatory approval. Specifically, the court considered whether Pfizer's representations about the efficacy and safety of Chantix, made through various promotional materials and communications, were misleading or deceptive, and whether these representations constituted advertising of a therapeutic good that had not been entered on the Australian Register of Therapeutic Goods.

The High Court found that Pfizer had contravened section 18 of the *Australian Consumer Law* by making misleading representations about Chantix. The court reasoned that the representations made by Pfizer, particularly concerning the drug's efficacy and safety profile, were not adequately substantiated and were therefore misleading to consumers. Furthermore, the court determined that Pfizer had contravened the *Therapeutic Goods Act 1989* by advertising Chantix without the necessary regulatory approval, as the drug had not been entered on the Australian Register of Therapeutic Goods at the time of the advertising. The court applied established principles of consumer protection law, focusing on the objective misleading nature of the representations and the strict requirements of the therapeutic goods regulatory framework.

The High Court upheld the appeal in part, finding that Pfizer had contravened both the *Australian Consumer Law* and the *Therapeutic Goods Act 1989*. The matter was remitted to the Federal Court for the determination of penalties and other remedies.