Ego Pharmaceuticals Pty Ltd and Minister for Health and Ageing

[2010] AATA 935

Administrative Appeals Tribunal

DECISION AND REASONS FOR DECISION [2010] AATA 935

ADMINISTRATIVE APPEALS TRIBUNAL      )

)          No 2008/4472

GENERAL ADMINISTRATIVE DIVISION        )

Re      Ego Pharmaceuticals Pty Ltd

Applicant

And    Minister for Health and Ageing

Respondent

DECISION

TribunalJustice Downes, President and Dr Schafer, Member

Date22 November 2010

Date of Written Reasons:      23 November 2010

PlaceSydney

Decision(1) Remit the matter to the decision-maker for reconsideration pursuant to s 42D of the Administrative Appeals Tribunal Act 1975 (Cth) in accordance with the Tribunal’s reasons dated 26 October 2010.

(2)The reconsideration is to take place within 56 days of the applicant lodging the results of further vasoconstrictor assay testing or within 56 days of an earlier request for reconsideration made by the applicant, but so that the reconsideration decision is made at the latest, in any event, by 31 January 2012.

(3)In the event that the results of the vasoconstrictor assay testing are satisfactory, the Tribunal indicates that its present inclination is that registration should be effected for each of the products unless some exceptional circumstance not now known or not now present requires a different result.

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

Garry Downes
  President

CATCHWORDS

PRACTICE AND PROCEDURE – power of remittal – power to give directions to decision-maker for reconsideration – matter remitted under s 42D with directions

RELEVANT ACT/S:

Administrative Appeals Tribunal Act 1975 (Cth)

REASONS FOR DECISION

22 November 2010	Justice Downes, President
Dr Schafer, Member

1.      The Tribunal gave detailed reasons in this matter on 26 October 2010, but was unable, on the material then available to it, to come to a final decision.  This is because the Tribunal was not satisfied that the pharmaceutical product under consideration should be registered, on the material then before it, but considered that with some particular further testing, registration would be appropriate.  The Tribunal, accordingly, stood the matter over to enable the parties to present submissions to it relating to the final decision it should make. 

2. There are three alternatives available to the Tribunal. The first, and in a sense the most logical, determination, is that the decision not to register the pharmaceutical products should be affirmed. I say this is the most logical consequence because the Tribunal is not satisfied on the material before it that registration should be effected and the usual consequence in those circumstances is that the decision under review is affirmed. However, the Tribunal, for reasons it has given, considers that the unusual course of providing an opportunity for some further testing to be carried out without the matter being finally disposed of, is the preferable decision in the present case. That takes me to the alternatives available. The first alternative is to set aside the decision under s 43 of the Administrative Appeals Tribunal Act 1975 (Cth) and remit the matter to the decision-maker for further consideration in accordance with directions from the Tribunal. It has been suggested that the Tribunal might not be able to adopt this course because there is not a basis in the material before the Tribunal to set aside the decision under review. We do not agree with this. It seems to us that the Tribunal can set aside a decision without making a determination that the decision under review was, with certainty, wrong. It seems to me that a decision can be set aside merely because it might be wrong and to give the opportunity for further consideration to that matter. However, there is a third alternative, which might be the most satisfactory way of disposing with this matter. The third alternative is a remittal under s 42D.

3. The Tribunal has power to remit for reconsideration under s 42D at any stage of proceedings and there is no suggestion that now is not such a stage. The section does not, however, in its terms, permit any direction as to the way in which the reconsideration is to be undertaken. The section needs to be considered in its context, however, and that context must be that, generally, something has occurred in the process of review which raises some particular matter or matters which are appropriate to be the subject of the reconsideration. In the present case, those matters relate to the possibility of undertaking similar testing to the testing that was carried out before, but undertaking that testing in a way which is not defective in any way. As the Tribunal indicated in its more detailed reasons, its present inclination is to think that, if further vasoconstrictor assay testing is satisfactory, then, unless other technical requirements are in issue, registration should be effected.

4. We have heard the submissions put both for and against the alternatives by the applicant and the respondent and we have taken them into account in coming to a conclusion, but we have decided that the best alternative to achieve justice between the parties in accordance with the provisions of s 2A and s 33 of the Act, and the preferable course in the present case, is to make a remittal under s 42D.

5. In the course of the proceedings this morning, we did indicate a form of order that we might make if we were to act under s 42D and we have taken into account the submissions put by both sides in finalising the order which we propose to make. The result is that the Tribunal makes the following orders:

(1)Remit the matter to the decision-maker for reconsideration pursuant to s 42D of the Administrative Appeals Tribunal Act 1975 (Cth) in accordance with the Tribunal’s reasons dated 26 October 2010.

(2)The reconsideration is to take place within 56 days of the applicant lodging the results of further vasoconstrictor assay testing or within 56 days of an earlier request for reconsideration made by the applicant, but so that the reconsideration decision is made at the latest, in any event, by 31 January 2012.

(3)In the event that the results of the vasoconstrictor assay testing are satisfactory, the Tribunal indicates that its present inclination is that registration should be effected for each of the products unless some exceptional circumstance not now known or not now present requires a different result.

I certify that the five (5) preceding paragraphs are a true copy of the reasons for the decision herein of Justice Downes, President and Dr Schafer, Member

Signed:   .....................[sgd]...................................................
  Alison Connor, Associate

Date/s of Hearing:  22 November 2010
Date of Decision:  22 November 2010
Date of Written Reasons                   23 November 2010
Solicitor for the Applicant:                  Thompson Eslick Solicitors
Counsel for the Applicant:                 Mr Jeremy Kirk
Solicitor for the Respondent:             DLA Phillips Fox
Counsel for the Respondent:           Ms Margaret Allars