Cat Media Pty Limited, Carotino (Australia) Pty Limited, Pharm-a-Care Laboratories Pty Ltd and Minister for Health and Aged Care

The Administrative Appeals Tribunal considered applications for a stay and non-publication orders made by Cat Media Pty Limited, Carotino (Australia) Pty Limited, and Pharm-a-Care Laboratories Pty Ltd. These applications arose from decisions by the Minister for Health and Aged Care to cancel the listing of certain therapeutic goods on the Australian Register of Therapeutic Goods.

The Tribunal was required to determine whether to grant a stay of the cancellation decisions and whether to issue a non-publication order. In considering the stay application, the Tribunal needed to assess factors such as the prospects of success of the substantive review, the need to secure an effective review, and the interests of the parties and the public. The Tribunal also had to consider the existing non-publication order in relation to the matter.

The Tribunal reasoned that its role was not to pre-empt the merits of the case, which would be determined at a full hearing. While a preliminary assessment of prospects of success was relevant for an interlocutory application, it was not to be a mini-hearing. The Tribunal noted that it was necessary to understand the points of contention, which centred on the Therapeutic Goods Act 1989 (Cth). This Act governs the listing of therapeutic goods on the Register, with significant commercial and reputational advantages for sponsors. Section 26A of the Act, concerning the labelling of medicines, requires that indications listed on a medicine's label must be covered by a determination under paragraph 26BF(1)(a) and proposed for acceptance in relation to the Register's inclusion. Indications are defined as the specific therapeutic uses of the goods.

The Tribunal refused the request for a stay of the cancellation decisions and the request for a new non-publication order, electing instead to maintain the existing non-publication order.