iNova Pharmaceuticals (Australia) Pty Ltd And Secretary, Department of Health and Ageing

Administrative Appeals Tribunal

DECISION AND REASONS FOR DECISION

[2011] AATA 305

ADMINISTRATIVE APPEALS TRIBUNAL )

) No: 2010/0912 and 2010/1097

GENERAL ADMINISTRATIVE DIVISION )
ReiNova Pharmaceuticals (Australia) Pty Ltd

Applicant

And Secretary, Department of Health and Ageing

Respondent

DECISION

TribunalMr R P Handley, Deputy President
Ms A K Britton, Senior Member

Date5 May 2011
PlaceSydney

Decision

1. The Tribunal finds:
(a) the information as to the existence of the documents sought in iNova’s FOI request in relation to imiquimod is not exempt under s 37(1)(a), s 43(1)(a) or s 43(1)(b) of the FOI Act; and
(b) the information as to the existence of the documents sought in iNova’s FOI request in relation to phentermine is not exempt under s 43(1)(a) or s 43(1)(b) of the FOI Act.

2. The Tribunal sets aside the Department’s reconsideration decisions dated 7 May 2010 and remits the matters for reconsideration with a direction that the Department provide to iNova a notice which contains information as to the existence or non-existence of the documents sought in the FOI requests. The notice is to provide information current as at the date of its issue in answer to the FOI requests made by iNova on 22 October 2009.

.....................[sgd]....................
Mr RP Handley
Deputy President

CATCHWORDS

FREEDOM OF INFORMATION – application for access to documents - therapeutic goods – applications to register a therapeutic product - power to issue statement of reasons without revealing whether documents are in the agency’s possession – exemptions – decision under review set aside

RELEVANT ACT

Freedom of Information Act 1982 (Cth): ss 37, 43, 61

CITATIONS

Re iNova Pharmaceuticals (Australia) Pty Ltd and Secretary, Department of Health and Ageing (2010) 116 ALD 448; [2010] AATA 542

Secretary, Department of Health and Ageing v iNova Pharmaceuticals (Australia) Pty Ltd and Anor [2010] FCA 1442

REASONS FOR DECISION

10 May 2011

Mr R P Handley, Deputy President

Ms A K Britton, Senior Member

The following statement of reasons for the decision was given orally at the conclusion of the hearing.

iNova Pharmaceuticals (Australia) Pty Ltd (iNova) applied for the review of decisions made by the Secretary of the Department of Health and Ageing under the Freedom of Information Act 1982 (Cth) (the FOI Act) to refuse access to documents fitting the description in iNova’s requests without informing iNova whether or not any such documents were in the Department’s possession.
The background to this matter was set out in the Tribunal’s decision in Re iNova Pharmaceuticals (Australia) Pty Ltd and Secretary, Department of Health and Ageing (2010) 116 ALD 448; [2010] AATA 542, a decision that was set aside on appeal to the Federal Court: Secretary, Department of Health and Ageing v iNova Pharmaceuticals (Australia) Pty Ltd and Anor [2010] FCA 1442. Justice Emmett remitted the matter to the Tribunal for reconsideration according to law.
There are two important factual matters to which attention should be drawn in these remittal proceedings. First, iNova’s FOI requests were made by letters dated 22 October 2009, and requested, in respect of phentermine:
a copy of any correspondence received by the Therapeutic Goods Administration and/or accepting into evaluation any Category 1 and/or Category 3 applications to register a therapeutic product containing the active ingredient phentermine made by sponsors other than iNova Pharmaceuticals in 2008-2009.

By a similar letter of the same date, access was sought to the same documents in relation to therapeutic products containing the active ingredient imiquimod.

Second, it should be noted that by letters dated 7 May 2010, a delegate of the Secretary of the Department, Dr Ruth Lopert, the Principal Medical Adviser in the Therapeutic Goods Administration, decided to refuse access to documents fitting the description in iNova’s requests without informing iNova whether or not any such documents were in the Department’s possession.
The Tribunal’s role is to review the reconsideration decisions made by Dr Lopert notified to iNova by letters dated 7 May 2010. In these remittal proceedings, the Department is no longer seeking to rely on the exemptions claimed in the reconsideration decisions nor is it seeking to rely on any other exemptions.
In these circumstances, given that pursuant to s 61(1) of the FOI Act the Department bears the onus of proof of establishing that its decisions to refuse access to the documents sought by iNova were justified, the Tribunal considers it appropriate to determine the matter without proceeding to a full hearing.
The Tribunal has decided that it is appropriate to make a decision in terms of the orders sought by iNova, to which the Department consents, with one additional sentence to clarify the information to be provided by the Department.

Decision

The Tribunal finds:
(a) the information as to the existence of the documents sought in iNova’s FOI request in relation to imiquimod is not exempt under s 37(1)(a), s 43(1)(a) or s 43(1)(b) of the FOI Act; and
(b) the information as to the existence of the documents sought in iNova’s FOI request in relation to phentermine is not exempt under s 43(1)(a) or s 43(1)(b) of the FOI Act.
The Tribunal sets aside the Department’s reconsideration decisions dated 7 May 2010 and remits the matters for reconsideration with a direction that the Department provide to iNova a notice which contains information as to the existence or non-existence of the documents sought in the FOI requests. The notice is to provide information current as at the date of its issue in answer to the FOI requests made by iNova on 22 October 2009.

I certify that the 9 preceding paragraphs are a true copy of the reasons for the decision herein of Mr R P Handley, Deputy President, and Ms A K Britton, Senior Member.

Signed: ...........[sgd].................................................................
A Veness, Associate

Dates of Hearing:  5 May 2011
Date of Decision:  5 May 2011
Date of written reasons:  10 May 2011
Applicant representative:                   Middletons
Applicant counsel:  M Allars
Respondent representative:              Australian Government Solicitor
Respondent counsel:  S Lloyd SC

iNova Pharmaceuticals (Australia) Pty Ltd, a pharmaceutical company, applied for access to documents under the Freedom of Information Act 1982 (Cth) (FOI Act) related to applications to register a therapeutic product. The Secretary, Department of Health and Ageing, the respondent, declined the application. The application was brought before the Administrative Appeals Tribunal (AAT) for review, and subsequently to the Federal Court of Australia for further review. The dispute centered on the scope of the statutory exemptions and whether the agency was required to reveal whether the documents were in its possession.

The primary legal issue was whether the agency's power to issue a statement of reasons, as provided by section 43 of the FOI Act, mandated the disclosure of whether the requested documents were in the agency's possession. Another issue was whether certain exemptions under the FOI Act, specifically sections 37 and 61, justified the agency's refusal to release the documents. The court had to determine if the decision to deny access to the documents was lawful and whether the agency's actions were in compliance with the FOI Act.

The court held that the power to issue a statement of reasons under section 43 of the FOI Act did not compel the agency to disclose whether the documents were in its possession. The court also found that the statutory exemptions applied, and the agency was not required to disclose the information. The decision of the AAT was set aside, and the matter was remitted back for reconsideration in light of the court's findings. The court clarified the scope of the statutory exemptions and the obligations of agencies under the FOI Act.

The final orders of the court were that the decision of the AAT be set aside and the matter be remitted to the AAT for reconsideration in accordance with the court's findings. The court also directed the agency to consider the implications of the decision regarding the disclosure of whether documents are in its possession when issuing a statement of reasons under the FOI Act.

CaseChat Overview and Summary

Orders of the court

Background to the litigation

Evidence Before The Court

Reasons for decision

Legal Principle Established