Minister for Health & Aged Care v Pharmacia & Upjohn Pty Ltd

REASONS FOR JUDGMENT THE COURT: 1 The appellant, the Minister for Health and Aged Care ("the Minister"), appeals to the Court from a decision of a judge of the Court (Beaumont J) dismissing an application by it for judicial review under the Administrative Decisions (Judicial Review) Act 1977 (Cth) of a decision of the Administrative Appeals Tribunal ("the Tribunal") constituted by a Senior Member (Mr Allen). The Senior Member had allowed an extension of time in which the first respondent Pharmacia and Upjohn Pty Ltd ("P&U") could lodge an application to the Tribunal to review a decision of a delegate of the Minister refusing to register a product named "Genotropin" for use on adults under s 25 of the Therapeutic Goods Act 1989 (Cth) ("TGA"). The chronological details are set out in the decision of the learned primary Judge. 2 The statutory scheme and the reasons of the Tribunal are likewise set out in the judgment appealed from. The judgment also sets out in detail the submissions advanced before the learned primary Judge which are substantially the same as those advanced before us. The submissions, as advanced (they were raised often under alternative heads of review), may be shortly stated but without reference to the particular grounds of review relied upon as follows: 1. The Tribunal failed to take into account that the extension of time would in this case, if granted, result in the Tribunal undertaking the merits review without the advantage of the full investigation as contemplated by the legislative scheme in respect of the evaluation of what may be described as fresh material. By fresh material is meant material which came into existence after the primary decision was made but not falling within the definition of "new information" under s 60(A)(8) of the TGA. 2. The Tribunal proceeded, in effect, on the application for an extension of time to decide the merits of the case in the way it discussed and considered the decision of a tribunal differently constituted in Re Eli Lilly Australia Pty Ltd v Minister for Health & Family Services (No. 2) [1999] AATA 565, (199) 56 ALD 541 (Eli Lilly (No. 2)) where registration had been granted of an "identical" product. 3. There was no evidence upon which the Tribunal could conclude that anything done or not done by P&U between 2 August 1999 and 14 December 1999 involved that company "agitating for registration of its product". 4. The Tribunal erred in concluding that there was an advantage to P&U to proceed with an application to the Tribunal for review of the original decision rather than to make a new application for registration of "Genotropin". 5. The learned primary Judge should have held that the Tribunal's decision was manifestly unreasonable. 3 We shall deal shortly with each of these submissions. 1. Although the submission in written form was put on the basis that the Tribunal's decision involved an "inversion" of the statutory scheme it really amounted to saying that the Tribunal gave little or no weight to the legislative scheme involving, as it does, on an original application, a departmental evaluation of evidence before a decision is made. In the ordinary course of an appeal to the Tribunal brought in time it might be expected, so it was said, that at the hearing little fresh material would have emerged different from material that had been the subject of investigation by a delegate of the Minister in the investigatory process. Given the time delay from application to hearing by the Tribunal which might be expected the factual assumption underlying this submission may be the subject of some doubt. But it can be accepted in the present circumstances that a substantial amount of fresh uninvestigated material will have emerged. It is not as if the Tribunal's reasons either ignored the legislative scheme or the existence of a substantial amount of fresh material. Rather this was but one of a number of factors which the Tribunal took into account. The weight it should give to these factors is a matter for the Tribunal and not this Court. 2. The Tribunal noted that the case of P&U would, if the extension of time were granted, have a reasonable prospect of success given that "Genotropin" was, according to the evidence before it, identical to the product the subject of the decision in Eli Lilly (No. 2) and that the decision in the present case was made by the same delegates as the decision which in Eli Lilly was found to be "deeply flawed". It is just not the case that the Tribunal embarked upon a merits inquiry in considering the application for an extension of time in the way that the Tribunal did in the case of Brown v Commissioner of Taxation [1999] FCA 563, approved on appeal (see Commissioner of Taxation v Brown 99 ATC 4852), to which the Tribunal itself referred. 3. In our view the inference drawn by the Tribunal and in the form in which the Tribunal stated its conclusion from that inference was available to it having regard to the meeting which took place on 20 October 1999 between Dr Mitchell and P&U. 4. The Tribunal in its reasons set out the evidence of Mr Feeney as to the number of hours which would be consumed in the making of a fresh application by the evaluation of evidence (and including no doubt re-evaluation of evidence already considered by the Minister) and the cost and delay to P&U if an extension of time to apply to the Tribunal were not granted. This evidence was not challenged in cross-examination and was clearly accepted by the Tribunal. The substance of the evidence, although not its detail, could clearly and reasonably be inferred as a matter of commonsense. There was clearly a detriment to P&U if an extension of time were not granted and the corresponding advantage to it if it was, which could be and was taken into account by the Tribunal.