Reckitt Benckiser (Australia) Pty Limited and Minister for Health and Ageing

[2009] AATA 441

Administrative Appeals Tribunal

DECISION AND REASONS FOR DECISION [2009] AATA 441

ADMINISTRATIVE APPEALS TRIBUNAL      )

)          No. 2007/5391

GENERAL ADMINISTRATIVE DIVISION		)
Re		Reckitt Benckiser (Australia) Pty Limited

Applicant

And Minister for Health and Ageing

Respondent

DECISION

Tribunal

The Hon B Tamberlin QC, Deputy President

Professor G.A.R. Johnston, Member

Date               18 June 2009

PlaceSydney

Decision The application for review should proceed to a full hearing on all questions and that there should be no preliminary determination.

.................[sgd].............................

The Hon B Tamberlin QC
  Deputy President

CATCHWORDS

Statutory interpretation – preliminary question of law – full hearing – reviewable decision – was condition imposed ultra vires? – consideration of legal issues and arguments – severability of legal question – no preliminary determination – matter to proceed to full hearing

Relevant Act

Therapeutic Goods Act 1989 – s 42DF

Relevant Case Law

Save the Ridge Inc v Commonwealth (2005) 147 FCR 97
Tepko Pty Ltd v Water Board (2001) 206 CLR 1; 75 ALJR 775
Corporation of the City of Adelaide v City of Salisbury (1998) EDCR 631
Shi v Migration Agents Registration Authority (2008) 235 CLR 286; 103 ALD 467; 48 AAR 345; 248 ALR 390

Brian Lawlor Automotive Pty Ltd and the Collector of Customs (1978) 1 ALD 167 Minister for Immigration and Multicultural Affairs (2005) 143 FCR 314

REASONS FOR DECISION

18 June 2009 Deputy President B Tamberlin and
Professor G.A.R. Johnston, Member

1. On 6 March 2009, Senior Member Allen of this Tribunal decided that the hearing of the application in this case should proceed by way of determination of a Preliminary Question which he described as a “statutory interpretation question”. The question referred to in the transcript of 6 March 2009 refers to the Applicants seeking to argue the question whether the delegate had power to subject the purported approval given under s 42DF of the Therapeutic Goods Act 1989 (“the Act”) to a condition.  He saw this as a matter which was appropriate to be considered by the Tribunal in a Preliminary Hearing.  Accordingly, he gave directions that submissions be lodged by the parties on the “statutory interpretation” question by 13 March 2009.

2.      When the matter came on for hearing of the Preliminary Question before the Tribunal, it became apparent that there were a substantial number of additional questions of law raised during the course of the proceedings and in the detailed oral and written submissions of the parties presented to us, including questions as to the interpretation and effect of the decision itself, the question whether the decision actually imposed the condition as alleged by the Applicant and whether, if the condition was ultra vires, it was severable so that the approval would remain operative without the condition.

Terms of the Decision

3.      The Delegate’s decision is in these terms:

I grant approval for the use of a restricted representation described below for use in advertisements about “Cardiprin 100” (aspirin 100 mg) tablets, other than those advertisements for which an approval is required under Part 2 of the Regulations.  The restricted representation relates to:

“Reduces blood clotting and reduces the risk of heart attack and stroke in patients with blood vessel disorders”.

The restricted representation should also include the words: For use under medical supervision only”

This approval is subject to the condition that all advertising must carry the statements required by the Therapeutic Goods Advertising Code Council (“the Code Council”) as set out below:

(i)A call for the intervention or advice of a doctor before use must be included;

(ii)An appropriate reference must be included to prevent substitution of the low-dose product with any other aspirin product without the advice of a healthcare professional;

(iii)There must be appropriate advice about lifestyle factors that can reduce the risk of heart attack or stroke;

(iv)There must be a reference to the benefit of an overall program for managing the risk of heart attack or stroke;

(v)The target audience needs to be appropriate, ie the advertising should target people who would be considered to be at risk of heart attack or stroke; and

(vi)That the considerations outlined above be given appropriate prominence in advertising.

This approval relates only to ‘Cardiprin 100’ (aspirin 100 mg) tablets and not to all low dose aspirin products.

4.      The Minister's first contention before the Tribunal is that it should vacate the hearing to address a Preliminary Question and have the matter set down for a hearing dealing with all matters, including the merits of the decision being reviewed.  The Minister also submits that the Preliminary Question is directed towards obtaining an advisory opinion from the Tribunal about the validity of only one aspect of the decision under review and that, in seeking a decision as to whether the alleged condition is ultra vires, the original decision maker, the Respondent, is seeking judicial review and not merits review.  The Minister says that determination of the question as framed before Senior Member Allen in this Tribunal will not dispose of the whole dispute.

5. The Tribunal has had the benefit of detailed written and oral submissions in relation to the power of the Delegate to impose conditions on the application made under s 42DF of the Act. In the course of submissions, it became apparent that this is not a case where it is appropriate to determine the legal issues on a preliminary basis and that the preferable course is to consider all legal arguments as to power, jurisdiction, and construction of both the Act and the terms of the decision under review, having regard to the factual context involving a comprehensive consideration of the merits of the application. Indeed, this Tribunal has been constituted to include an expert member expressly for the purpose of determining the merits issues in this case, which are both significant and technically complex, relating to the use and effectiveness of low dose aspirin in relation to heart attacks and stroke treatment and prevention.

6. The determination of the preliminary question in this case as suggested will not finally determine the outcome of the proceeding. It may be open to the Tribunal when making “the correct and preferable decision” in the present case to grant an approval, if the case warrants, which does not have any conditions or the condition referred to by the Applicant. There is room for argument in this case that the “condition” challenged is not a condition but simply a recital of the terms of s 42DA of the Act. In those circumstances, the validity of the condition and the question whether it can be severed from an approval may not arise and, accordingly, any opinion given on the preliminary matter will be hypothetical and unnecessary. In this case, the Tribunal is not concerned only with a separate discrete question of construction which can be considered independently from the evidence to be adduced and from the findings made by the Tribunal. The procedure of formulating and deciding a separate or preliminary question should only be adopted with caution and can be fraught with many difficulties: see Save the Ridge Inc v Commonwealth (2005) 147 FCR 97.

7.      This is a case where fact and law are so intertwined that it is undesirable to attempt to dispose of the matter by way of preliminary hearing.  It cannot be said that the question is ripe for separate and preliminary determination because its outcome will not obviate the necessity of further litigation or substantially narrow the field of controversy.  The question sought to be raised is only appropriate to be determined in the context of a comprehensive examination of the evidence and submissions all of fact and law, and this will depend of course on the evidence led to and accepted by the Tribunal.

8.      Applying the practical test of utility, efficiency, and convenience in the administration of justice, the considerations point to a full hearing on both fact and law: see Tepko Pty Ltd v Water Board (2001) 206 CLR 1; 75 ALJR 775. Indeed, the determination of the preliminary questions suggested could readily lead to a multiplicity of proceedings and the incurring of substantial further cost arising from appeals, as a consequence of the preliminary determination, and this could result in the matter being remitted for hearing on the merits after a substantial period of delay.

9.      It is significant that in the present case, the Tribunal is concerned with claims concerning therapeutic goods and it is imperative that such matters should be finally determined thoroughly and with expedition.  This Tribunal has the objective of providing a mechanism of review that is fair, just, economical, informal, and quick and this must be borne in mind.  The making of determinations on preliminary questions of law going to questions of the power of the decision maker can often be unproductive and we consider that this is so in the present case in circumstances where the question may never arise if, after a review on the merits, the Tribunal refuses to approve or does not consider that any condition is required.

10.     In addition to the question as to whether there was power to impose the condition in question, the Applicant seeks a preliminary determination that the approval given remains valid notwithstanding that the condition imposed was beyond power.  This raises a further additional and complex issue of severability to that which was foreshadowed before Senior Member Allen in this Tribunal.  The Tribunal is now being asked also to determine whether the condition was so fundamental to the approval that such approval would not have been given without the condition:  see Corporation of the City of Adelaide v City of Salisbury (1998) EDCR 631 at 644. This is a complex additional question to that foreshadowed before the Senior Member. Also, the Applicant now seeks to rely on an amendment to the legislation to support his submissions. Again, this argument was not a matter discussed in any detail before the Senior Member when deciding that there should be a determination of the preliminary issue. Also in addition, an argument emerged before the Tribunal as to whether the terms of the regulation can affect the interpretation of the language of the Act under which the regulation is made. The fact that the nature and extent of the questions now sought to be canvassed by the Applicant has changed from a short “question of statutory construction” to a myriad of perceived legal questions militates strongly against determining this question by way of a Preliminary Hearing.

11.     With the benefit of detailed oral and written argument and a consideration of the authorities from both parties in relation to the legal questions perceived to arise in the present case, we have reached the firm view that the matter should be set down for hearing on all issues;  that there should be no hiving off of any questions by way of Preliminary Determination in the circumstances of this case.

12.     In reaching this conclusion, we have had particular regard to the decision of the High Court in Shi v Migration Agents Registration Authority (2008) 235 CLR 286; 103 ALD 467; 48 AAR 345; 248 ALR 390 at [32] – [37] and [96] – [99], where the Court observed that the Tribunal must determine whether the decision under review was the “correct or preferable one” and that the Tribunal’s task is to “do over again” what the original decision maker did. The fact that the decision under review might have been ultra vires does not mean that the decision cannot be reviewed by the Tribunal: see Brian Lawlor Automotive Pty Ltd and the Collector of Customs (1978) 1 ALD 167 and Minister for Immigration and Multicultural Affairs (2005) 143 FCR 314 at [42]. The task of the Tribunal is not limited to correcting demonstrated error in administrative decision-making in a manner analogous to a strict appeal in judicial proceedings.

13.     Accordingly, the decision of the Tribunal is that this application for review should proceed to a full hearing on all questions and that there should be no preliminary determination.

I certify that the thirteen (13) preceding paragraphs are a true copy of the reasons for the decision herein of
The Hon B Tamberlin QC, Deputy President and Professor G.A.R. Johnston, Member

Signed:  ................................[sgd]............................................
  Associate

Date of Hearing   7 May 2009
Date of Decision   18 June 2009
Counsel for the Applicant          Mr A Anforth
Solicitor for the Applicant           Mr P Le Guay, Thomson Playford Culters
Counsel for the Respondent     Mr S Lloyd, SC and Ms B Tronson
Solicitor for the Respondent      Ms J Pownall, Australian Government Solicitor