PFIZER AUSTRALIA PTY LTD and MINISTER , DEPARTMENT OF HEALTH AND AGEING
[2012] AATA 812
•20 November 2012
Administrative Appeals Tribunal
ADMINISTRATIVE APPEALS TRIBUNAL )
)No: 2012/4333
General Administrative Division )
Re: Pfizer Australia Pty Ltd
Applicant
And: Minister for Health & Ageing
Respondent
DIRECTION
TRIBUNAL: Robin Creyke, Senior Member
DATE: 22 November 2012
PLACE: Canberra
The Tribunal directs the Registrar, pursuant to subsection 43AA(1) of the Administrative Appeals Tribunal Act 1975, to alter the text of the decision in this application:
- at the decision summary on page 1, to delete the words ‘The claim for confidentiality under section 35(2)(c) is denied’ and to insert the words:
‘1. The claim for confidentiality under section 35(2)(c) over document T8 is granted;
2. The claim for confidentiality under section 35(2)(c) over documents T34 and T35 is denied.’ ; and,
2.at paragraph 5, on page 3 of the decision, after the words ‘…that application was not pressed.’ to insert the words ‘As such, the confidentiality order for document T8 is granted.’; and,
3.at paragraph 6, on page 3 of the decision, after the words ‘The second application for a confidentiality order related to two documents’ to insert the words ‘, T34 and T35,’ ; and,
4.at paragraph 10, on page 5 of the decision, after the words ‘Did the documents’ to insert the words ‘T34 and T35’; and
5.at paragraph 20, on page 9 of the decision, after the words ‘For the present purposes the documents’ to insert the words ‘T34 and T35’.
………………………[sgd]………………………
PROFESSOR RM CREYKE, SENIOR MEMBER
[2012] AATA 812
Division GENERAL ADMINISTRATIVE DIVISION File Number(s)
2012/4333
Re
PFIZER AUSTRALIA PTY LTD
APPLICANT
And
MINISTER , DEPARTMENT OF HEALTH AND AGEING
RESPONDENT
Decision
Tribunal PROFESSOR RM CREYKE, SENIOR MEMBER
Date 20 November 2012 Place Canberra 1. The claim for confidentiality under section 35(2)(c) over document T8 is granted;
2. The claim for confidentiality under section 35(2)(c) over documents T34 and T35 is denied.
.............................[sgd]...........................................
PROFESSOR RM CREYKE, SENIOR MEMBER
Catchwords
INTERLOCUTORY DECISION – confidentiality order – legal professional privilege claim – relevance of documents
Legislation
Administrative Appeals Tribunal Act 1975 (Cth) ss 35, 37(1)(b).
Therapeutic Goods Act 1989 (Cth) s 60(3)
Cases
Australian Prudential Regulation Authority (APRA) v VBN (2005) 88 ALD 403
Re Farnaby and Military Rehabilitation and Compensation Commission (2007) 97 ALD 788
Re Esso Australia Resources Ltd v Commissioner of Taxation (1999) 201 CLR 49
Re Sumabe Pty Ltd and Minister for Health and Ageing (2011) 125 ALD 327
Waterford v Commonwealth (1987) 163 CLR 54REASONS FOR INTERLOCUTORY DECISION
PROFESSOR RM CREYKE, SENIOR MEMBER
Pfizer Australia Pty Ltd (Pfizer) had applied under the Therapeutic Goods Act 1989 (Cth) (TG Act) to register Xalatan eye drops (latanoprost 50 micrograms/mL) on the Australian Register of Therapeutic Goods. The application was rejected by a delegate of the Secretary of the Department of Health and Ageing (Agency) on 16 April 2012 under section 25 of the TG Act, a decision affirmed on review by a delegate of the Minister under section 60(3) of the TG Act on 5 September 2012. On 4 October 2012 Pfizer sought further review by the Tribunal under section 60(6) of the TGA Act.
Following the lodgement of the documents required by the Tribunal under section 37 of the Administrative Appeals Tribunal Act 1975 (Cth) (AAT Act), an application was made by Pfizer for a confidentiality order under section 35(2)(c) of the AAT Act in relation to certain of those documents.
Background
The reviewable decision contained several reasons for the rejection of the application. These were principally that:
·information provided in the material supporting the application had been for products which were similar but not identical in composition to latanoprost at pH 6.0;
·No clinical studies had been provided for latanoprost at pH 6.0;
·The safety profile of latanoprost at pH 6.0 was unable to be established by reference to the data provided; and
·The information about the safety of other products at lower pH levels and the apparent acceptability of their safety profiles did not provide sufficient or clear supporting information about the proposed products safety profile.
The delegate of the Secretary took the view that the eye drops with the varied amounts of the phosphate agent buffers constituted a new 'therapeutic good' within the meaning of section 16 of the TG Act. Accordingly it was necessary under section 25(1)(d) of the TG Act for the delegate of the Secretary to assess the safety, quality and efficacy of the product afresh.
Confidentiality
The ground for the application for the confidentiality order in relation to one document was to prevent the identity being disclosed of a TGA external evaluator. At the interlocutory hearing that application was not pressed. As such, the confidentiality order for document T8 is granted.
The second application for a confidentiality order related to two documents, T34 and T35, claimed to be subject to legal professional privilege. It was those documents which were the subject of the submissions at the interlocutory hearing.
The representative for the agency contended that the two documents were subject to legal professional privilege, having been created by TGA's in-house lawyers for the dominant purpose of providing legal advice to the delegate of the Minister. It was further submitted that in providing that legal advice, the in-house lawyers were at all times acting in their capacity as professional legal advisors to the TGA. There was no question that the agency had lodged documents with the Tribunal in accordance with the requirements of section 37 of the Administrative Appeals Tribunal Act 1975 (Cth) (AAT Act).
Legislation
The relevant provision of the AAT Act relating to confidentiality orders is found in section 35.
35 (1) Subject to this section, the hearing of a proceeding before the Tribunal shall be in public.
...
(2) Where the Tribunal is satisfied that it is desirable to do so by reason of the confidential nature of any evidence or matter or for any other reason, the Tribunal may, by order:
...
(c) give directions prohibiting or restricting the disclosure to some or all of the parties to a proceeding of evidence given before the Tribunal, or of the contents of a document lodged with the Tribunal or received in evidence by the Tribunal, in relation to the proceeding.
(3) In considering: ...
(b) whether publication, or disclosure to some or all of the parties, of evidence given before the Tribunal, or of a matter contained in a document lodged with the Tribunal or received in evidence by the Tribunal, should be prohibited or restricted;
the Tribunal shall take as the basis of its consideration the principle that it is desirable that hearings of proceedings before the Tribunal should be held in public and that evidence given before the Tribunal and the contents of documents lodged with the Tribunal or received in evidence by the Tribunal should be made available to the public and to all the parties, but shall pay due regard to any reasons given to the Tribunal why the hearing should be held in private or why publication or disclosure of the evidence or the matter contained in the document should be prohibited or restricted.
The relevant provisions of the AAT Act dealing with the lodgement of documents and their relevance, provides:
Decision-maker must lodge statement of reasons and relevant documents
(1) Subject to this section, a person who has made a decision that is the subject of an application for a review by the Tribunal must, within 28 days after receiving notice of the application (or within such further period as the Tribunal allows), lodge with the Tribunal 2 copies of:
(a) a statement setting out the findings on material questions of fact, referring to the evidence or other material on which those findings were based and giving the reasons for the decision; and
(b) every other document or part of a document that is in the person's possession or under the person's control and is relevant to the review of the decision by the Tribunal. ...
(1AE) A person who is required under subsection (1) or (1AB) to lodge 2 copies of a statement or other document or part of a document with the Tribunal under this section within a particular period must also give a copy of the statement or other document or part of a document within that period to each other party to the proceeding.
When document not required to be lodged
(1AF) If:
(a) a person who has made a decision that is the subject of an application for a review by the Tribunal would, apart from this subsection, be required under paragraph (1)(b) to lodge 2 copies of a document or a part of a document with the Tribunal in respect of the application; and
(b) within the period applicable under subsection (1) the person:
(i) applies to the Tribunal for a direction under subsection 35(2) in relation to the document or part of the document and lodges with the Tribunal, together with the application for the direction, 2 copies of the document or part of the document; and
(ii) gives a copy of the application for the direction to each party to the application for review;
the person is not required to comply with paragraph (1)(b) in relation to the document or part of the document unless and until the Tribunal, after hearing the application for the direction, directs the person to do so.
(1AG) Subsection (1AF) does not affect the obligation of a person referred to in that subsection to comply with paragraph (1)(b) in relation to any document or part of a document to which that subsection does not apply. ...
...
Privilege and public interest
(3) This section has effect notwithstanding any rule of law relating to privilege or the public interest in relation to the production of documents.
Issues
The issues to be considered by the Tribunal are:
·Did the documents attract legal professional privilege?
·If the documents did attract legal professional privilege, should they nonetheless be provided to Pfizer?
There is no issue that legal professional privilege may apply to documents lodged with the Tribunal.[1] Those documents must also be lodged with the Tribunal under section 37(1)(b),(2) of the AAT Act.[2] The documents which must be lodged are those documents that are under the ‘possession or control’ of the agency which made the decision and that are ‘relevant to the review of the decision by the Tribunal’.[3] ‘Relevant’ means relevant in an objective sense.[4] Section 37(3) requires 'earlier provisions of s 37 to be given full effect, in the sense that privilege cannot be advanced as a reason or excuse for not complying with those sub-sections'.[5]
[1] Re Farnaby and Military Rehabilitation and Compensation Commission (2007) 97 ALD 788.
[2] Australian Prudential Regulation Authority (APRA) v VBN (2005) 88 ALD 403 (Ryan J).
[3] Administrative Appeals Tribunal Act 1975 (Cth) (AAT Act) s37(1)(b).
[4] Id at [7].
[5] Id at [8].
At the same time, section 35(2) of the AAT Act provides an exception to the general openness principles applicable in Tribunal proceedings. In particular, the Tribunal may give directions prohibiting or restricting the disclosure to some or all of the parties to a proceeding of ‘the contents of a document lodged with the Tribunal’.[6] The exercise of this power requires argument as to the reasons for such prohibition or restriction. In this matter, the contention was that the documents attracted legal professional privilege.
[6] AAT Act s 35(2)(c).
The contention required the Tribunal to be satisfied of two matters: were the documents relevant; and were they properly the subject of an application for legal professional privilege. Having examined the documents, the Tribunal considered that objectively the documents were relevant in a general sense, having been provided as part of the review processes involved in the administrative proceedings. The question of relevance is informed by subject matter and context.[7] The point is illustrated by the comment of Ryan J in Australian Prudential Regulation Authority v VBN[8]:
The fact that the legal advice in the documents in question may have been relied upon by the original decision-maker in deciding to disqualify VBN would sufficiently connect it with the review by the Tribunal to make the document ‘relevant’ in the sense in which that term is used in s 37(1).
[7] Id at [11].
[8] Australian Prudential Regulation Authority (APRA) v VBN (2005) 88 ALD 403 at [28].
The second issue was whether the documents had been produced for the dominant purpose of providing legal advice,[9] in the course of administrative proceedings,[10] and that the privilege had not been waived. Again, in general terms, the Tribunal is satisfied that the documents had been produced for the dominant purpose of providing legal advice, in that they were documents provided in the course of drafting a decision in this matter. Nor had there been any waiver of the documents as they had not otherwise been disclosed or referred to by the agency in its dealings with Pfizer.
[9] Esso Australia Resources Ltd v Commissioner of Taxation (1999) 201 CLR 49.
[10] Waterford v Commonwealth (1987) 163 CLR 54.
The representative of the agency advised that the documents had been included in the documents lodged with the Tribunal as a matter of caution, and in deference to an opinion on a similar issue expressed by the Tribunal in Re Sumabe Pty Ltd and Minister for Health and Ageing.[11] In that decision, following a thorough analysis of the relevant cases, a document described as 'legal advice provided to the maker of the decision under review' was found to be subject to legal professional privilege. The relevant passages which attracted legal professional privilege related to the interpretation of a relevant statutory provision and were said to be procedural matters. In the course of its reasons, the Tribunal had said:
The document came into existence in the Respondent’s consideration of the very matter before the Tribunal. I do not think it appropriate to adopt an approach whereby each paragraph of a document, which is clearly identified as legal advice, is evaluated as to whether it in fact provides legal advice or advice on ‘mere’ procedural matters. Errors in decision-making can occur in ‘procedural matters’ and avoidance of such errors can properly be the subject of legal advice.[12]
[11] Re Sumabe Pty Ltd and Minister for Health and Ageing (2011) 125 ALD 327.
[12] Id at [11].
It appears from the discussion at the hearing that the agency has interpreted this passage as meaning that in any case in which there is a document referring to procedural matters, that document must be produced to the Tribunal to satisfy the requirements of section 37 of the AAT Act.
The Federal Court has described the nature of the documents for which an exemption for disclosure on the ground of legal professional privilege may be justified.[13] Those documents include any legal advice or opinion regarding the interpretation of the law which was 'present to the mind of the decision-maker when making the decision under review'.[14] Such advice or opinion may relate to the meaning of a provision affecting substantive matters under the relevant legislation, or matters of procedure affecting the decision, including statutory procedural requirements.
[13] Australian Prudential Regulation Authority (APRA) v VBN (2005) 88 ALD 403 at [32].
[14] Ibid.
However, that does not mean, and it may not have been intended by the quoted passage from Sumabe to include, all 'procedural matters', regardless of whether they were present in the decision-maker's mind in the sense mentioned. Not all such procedural matters would be relevant in the objective sense required. Nor would they necessarily have been relied on by the decision-maker in reaching the decision under review. It is not every document containing legal advice or opinion which was in existence and available which is relevant. It is only those expressions of legal advice or opinion which were referred to or considered by either the original decision-maker or the decision-maker who confirmed that decision which are sufficiently relevant for the purpose of an application for confidentiality on grounds of legal professional privilege.[15]
[15] Australian Prudential Regulation Authority (APRA) v VBN (2005) 88 ALD 403 at [31].
In the matter under review, the advice or opinion related principally to matters of drafting and style including the clarity of the form of expression of the statutory test for an application under section 16 of the TG Act. They were matters commonly encountered in documents within public administration where improvement of initial drafts of a decision is suggested by more experienced or senior officers in order to ensure the accuracy and clarity of the expression of the document and its reasoning processes. Whether such matters are sufficiently significant so as to be 'present to the mind' of the decision-maker and, by implication pertinent to the terms in which the reviewable or initial decision is couched, will be a matter of fact and degree in each case.
For present purposes the documents T34 and T35 over which privilege is claimed in this matter did not meet that test. In those circumstances, the documents were not relevant and there was no need to include them in the section 37 documents. In those circumstances, there is no need to seek a confidentiality order on grounds of legal professional privilege in relation to the documents. The documents should be removed from the section 37 documents and returned to the agency.
I certify that the preceding 20 (twenty) paragraphs are a true copy of the reasons for the decision herein of Professor RM Creyke, Senior Member. ........................................................................
Associate
Dated 20 November 2012
Date(s) of hearing 9 November 2012 Counsel for the Applicant Alan Anforth Advocate for the Applicant Doug Kentwell Solicitors for the Applicant Regulatory Solutions Pty Ltd Counsel for the Respondent Matthew Swainson Advocate for the Respondent Navreen Kular Solicitors for the Respondent Therapeutic Goods Administration
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