Roche Products Pty Ltd v National Drugs and Poisons Schedule Committee

Roche Products Pty Ltd sought judicial review of decisions made by the National Drugs and Poisons Schedule Committee (the Committee) regarding the scheduling of orlistat, a drug used for weight loss, under the Therapeutic Goods Act 1989 (Cth). The Committee had decided to include orlistat in Appendix H of the Poisons Standard, allowing for its advertising, despite earlier rejections due to concerns about misleading advertising and public health. Roche argued that the decisions were unreasonable, lacked evidence, and were improperly influenced by external parties.

The primary legal issue was whether the Committee's decisions were administrative in nature, thus subject to judicial review under the Administrative Decisions (Judicial Review) Act 1977 (Cth), or whether they were legislative, which would preclude such review. The court needed to determine if the Committee's actions involved the creation of new rules of general application or the application of existing rules to specific cases.

The court concluded that the Committee's exercise of power under section 52D(2) of the Act was legislative rather than administrative. This conclusion was based on the consideration that the decisions involved the creation of new rules for the scheduling of therapeutic goods, rather than the application of existing rules to specific cases. Consequently, the court held that Roche's application for judicial review was incompetent to the extent it sought to invoke the jurisdiction of the Court under the ADJR Act. The court also rejected Roche's arguments that the decisions were unreasonable, lacked evidence, or were improperly influenced.

The court dismissed Roche's application and ordered Roche to pay the costs of the respondent. This decision underscored the importance of distinguishing between legislative and administrative functions in the context of judicial review.