Neo Health (OTC) Pty Ltd and Minister for Health and Aged Care

This matter came before the Administrative Appeals Tribunal (AAT) concerning an interlocutory application by Neo Health (OTC) Pty Ltd (the applicant) for the remittal of a decision made by the Minister for Health and Aged Care (the respondent). The dispute centred on whether the respondent's decision should be remitted for reconsideration pursuant to section 42D of the *Administrative Appeals Tribunal Act 1975* (Cth), and whether such a remittal would align with the objectives of the AAT Act.

The primary legal issue before the Tribunal was whether to exercise its discretion under section 42D of the AAT Act to remit the respondent's decision for reconsideration. This involved determining whether such a remittal would be consistent with the overarching objectives of the AAT, as outlined in section 2A of the Act, which include providing a fair, just, informal, quick, and economical review process. The Tribunal also considered the respondent's arguments that a remittal would be unlikely to resolve the matter, would cause undue delay, and would constitute an inappropriate use of the Tribunal's processes, particularly if the applicant intended to submit a substantially new application.

The Tribunal reasoned that the power to remit under section 42D is discretionary and should be exercised based on the specific circumstances of each case. It acknowledged that case management procedures are central to this power. In this instance, the application for remittal was made at the outset of the review process, before the parties had gathered further evidence, including potential expert evidence. The Tribunal found the respondent's contention that the applicant's proposed further studies would have little bearing on the decision to be speculative. Furthermore, the Tribunal noted that the alternative proposed by the respondent – for the applicant to either proceed with the current review or lodge a fresh application with the Therapeutic Goods Administration (TGA) – was neither quick nor economical, given the significant fees and lengthy waiting times associated with a new TGA application. The Tribunal concluded that a remittal would serve as an appropriate case management procedure, allowing the applicant to present its case with supporting evidence and ensuring the Tribunal is fully informed.

Consequently, the Tribunal ordered that the matter be remitted to the respondent for reconsideration of the decision made on 30 March 2023. The applicant was directed to provide the results of further studies aimed at establishing bioequivalence between its product, Polyfer, and the reference product, Maltofer, by 1 September 2024. The respondent was then to reconsider the decision within 180 working days from that date, subject to regulation 16A of the *Therapeutic Goods Regulations 1990* (Cth).