Minister for Health & Aged Care v Pharmacia & Upjohn Pty Ltd [2001] FCA 75 (13 February 2001)

Last Updated: 14 February 2001

NO QUESTION OF PRINCIPLE

FEDERAL COURT OF AUSTRALIA

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

[2001] FCA 75

MINISTER FOR HEALTH AND AGED CARE v

PHARMACIA AND UPJOHN PTY LTD (ACN 000185526) AND OTHERS

N 1042 of 2000

HILL, WHITLAM AND TAMBERLIN JJ

13 FEBRUARY 2001

SYDNEY

IN THE FEDERAL COURT OF AUSTRALIA
NEW SOUTH WALES DISTRICT REGISTRY	N 1042 OF 2000

ON APPEAL FROM A JUDGE OF THE FEDERAL COURT OF AUSTRALIA

BETWEEN:	MINISTER FOR HEALTH AND AGED CARE APPLICANT
AND:	PHARMACIA AND UPJOHN PTY LTD (ACN 000185526) FIRST RESPONDENT SENIOR MEMBER M D ALLEN sitting as THE ADMINISTRATIVE APPEALS TRIBUNAL SECOND RESPONDENT HER HONOUR JUSTICE DEIDRE O'CONNOR in her capacity as the PRESIDENT OF THE ADMINISTRATIVE APPEALS TRIBUNAL THIRD RESPONDENT
JUDGE:	HILL, WHITLAM AND TAMBERLIN JJ
DATE OF ORDER:	13 FEBRUARY 2001
WHERE MADE:	SYDNEY

THE COURT ORDERS THAT:

1. The appeal be dismissed.

2. The appellant to pay the respondents' costs.

Note: Settlement and entry of orders is dealt with in Order 36 of the Federal Court Rules.

IN THE FEDERAL COURT OF AUSTRALIA
NEW SOUTH WALES DISTRICT REGISTRY	N 1042 OF 2000

ON APPEAL FROM A JUDGE OF THE FEDERAL COURT OF AUSTRALIA

BETWEEN:	MINISTER FOR HEALTH AND AGED CARE APPLICANT
AND:	PHARMACIA AND UPJOHN PTY LTD (ACN 000185526) FIRST RESPONDENT SENIOR MEMBER M D ALLEN sitting as THE ADMINISTRATIVE APPEALS TRIBUNAL SECOND RESPONDENT HER HONOUR JUSTICE DEIDRE O'CONNOR in her capacity as the PRESIDENT OF THE ADMINISTRATIVE APPEALS TRIBUNAL THIRD RESPONDENT
JUDGE:	HILL, WHITLAM AND TAMBERLIN JJ
DATE:	13 FEBRUARY 2001
PLACE:	SYDNEY

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) [1999] AATA 565; 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.

Additionally, it was submitted that his Honour at paragraph 30 of his reasons had misstated a submission put by the Minister in relation to the question of commercial advantage to P&U. We have considered the submission which appears to proceed on the basis that the Tribunal assumed, although not stating it, that a fresh application for approval would be refused. But there is nothing in the Tribunal's reasons which suggests that it proceeded on this basis. That there would be a commercial advantage to P&U in proceeding with its application to the Tribunal was self-evident and in accordance with the evidence we have already referred to.

5. In our view his Honour did not err and for the reasons he gave in concluding that the Tribunal's decision was open to it and not such as to be manifestly unreasonable.

4 Accordingly we agree with his Honour and, subject to the above comments, for the reasons his Honour advanced, that the application to this Court by the Minister should be dismissed. The appeal is therefore dismissed with costs.

I certify that the preceding four (4) numbered paragraphs are a true copy of the Reasons for Judgment herein of the Court.

Associate:

Dated: 13 February 2001

Counsel for the Appellant:	A Robertson SC, R Beech-Jones
Solicitor for the Appellant:	Australian Government Solicitor
Counsel for the Respondents:	S Gageler SC, P Braham
Solicitor for the Respondents:	Minter Ellison
Date of Hearing:	12 February 2001
Date of Judgment:	13 February 2001