WHITELY ApplicantAndDEPARTMENT OF HEALTH AND AGEING

[2010] AATA 338

Administrative Appeals Tribunal

DECISION AND REASONS FOR DECISION [2010] AATA 338

ADMINISTRATIVE APPEALS TRIBUNAL      )

)          No 2009/2499

GENERAL ADMINISTRATIVE  DIVISION		)
Re		MARTIN WHITELY

Applicant

And DEPARTMENT OF HEALTH AND AGEING

Respondent

DECISION

Tribunal Deputy President S D Hotop
Professor G A R Johnston, Member

Date7 May 2010

PlacePerth

Decision The Tribunal varies the decision under review by determining that each of documents 1, 2, 3, 4, 5, 7, 8, 9 and 11 is an exempt document by virtue of s 38(1) of the Freedom of Information Act 1982 (Cth).

..........[sgd S D Hotop]........

Deputy President

CATCHWORDS

FREEDOM OF INFORMATION – applicant requested access to documents in relation to listing of drug on Pharmaceutical Benefits Scheme under National Health Act – respondent granted partial access to certain documents and refused access to other documents – disclosure of information in each of those documents prohibited by provision of National Health Act – each of those documents is an exempt document – Tribunal does not have power to grant access to those documents – decision under review varied

Freedom of Information Act 1982 (Cth), s 3, s 4(1), s 11, s 38, s 58 and s 61

National Health Act 1953 (Cth), s 100A, s 100B, s 101, s 101A and s 135A(1)

Re Advocacy of the Aged Association Inc and Department of Health, Housing and Community Services  [1992] AATA 319

Re Caruth and Department of Health, Housing, Local Government and Community Services [1993] AATA 187

REASONS FOR DECISION

7 May 2010 Deputy President S D Hotop
Professor G A R Johnston, Member

Introduction

1.      Martin Whitely (“the applicant”) seeks access under the Freedom of Information Act 1982 (Cth) (“FOI Act”) to documents in the possession of the Department of Health and Ageing (“the respondent”) in relation to the listing of a particular drug (“Strattera”) on the Pharmaceutical Benefits Scheme (“PBS”) established under Part VII of the National Health Act 1953 (Cth) (“National Health Act”).

2.      The respondent has granted the applicant full access to some documents and partial access to other documents and it has refused the applicant access to certain documents.

3.      The applicant seeks from this Tribunal a decision that he be granted full access to those documents in respect of which he has been refused access or granted only partial access.

The Factual Background

4. The following background facts appear from the documents (“T Documents”, T1–T20, pp 1–88) lodged with the Tribunal by the respondent in accordance with s 37 of the Administrative Appeals Tribunal Act 1975 (Cth), and are not in dispute.

5.      On 24 November 2008 the respondent received from the applicant a letter, dated 13 November 2008, in the following terms:

“ Re: PBAC consideration November 2006 for approval of Atomoxetine Hydrochloride, capsules 10mg, 18mg, 25mg, 40mg, and 60mg, Strattera® for PBS listing

In November 2006 the Pharmaceutical Benefits Advisory Committee (PBAC) approved the listing of Strattera® on the Pharmaceutical Benefits Scheme at an estimated annual cost, for the first 4 years, to be in the range of $10 - $30 million.

In relation to that listing I am seeking the following under the Freedom of Information Act 1982

·     All documents provided to the PBAC in their determination that Strattera® should be placed on the PBS.

·     Documentation outlining specific consideration given by the PBAC regarding Strattera’s black box warnings for suicidal ideation.

…” (T3)

6. By letter dated 17 December 2008 the respondent, pursuant to s 27 of the FOI Act, sought the views of Eli Lilly Australia Pty Ltd (“Eli Lilly”) (which had applied for the listing of “Strattera” on the PBS) regarding disclosure under the FOI Act of 10 specified documents relating to that matter. (T5)

7. By letter dated 15 January 2009 Eli Lilly apprised the respondent of its view that the abovementioned documents (with the exception of “Document 10”) are exempt documents under ss 41, 43 and 45 of the FOI Act and should not be released under that Act. (T7)

8. On 23 January 2009 the respondent sent an e-mail to Eli Lilly seeking its views on the release under the FOI Act of two additional documents, and, by letter dated 28 January 2009, Eli Lilly responded that those documents “should be exempt from release under the FOI Act” pursuant to ss 43 and 45 of that Act. (T8, T9)

9.      By letter dated 28 January 2009 an officer of the respondent wrote to the applicant as follows:

“ I refer to your letter of 13 November 2008, in which you sought access under the Freedom of Information Act 1982 (the FOI Act) to copies of documents relating to the listing of atomoxetine (Strattera®) on the Pharmaceutical Benefits Scheme (PBS).

This letter sets out my decision on your request for access. I am currently acting Assistant Secretary, Pharmaceutical Evaluation Branch and am an authorised decision-maker under section 23 of the FOI Act.

Decision

I have identified 11 documents relevant to your request.  I have decided to release 2 in full and to release 7 in part.  I have decided that two documents are wholly exempt from disclosure.  My reasons for this decision are set out at Attachment A to this letter.  At Attachment B is a schedule setting out each document and detailing my decision in relation to each document.

…

Documents subject to third party appeal rights

Although I have decided to release all or parts of 9 documents to you, a third party has objected to the disclosure of 8 of those documents.  As such, I am unable to provide access to those documents until the third party has had an opportunity to exercise their appeal rights.  The Department will keep you informed in relation to any third party appeal on these documents.  A third party has 30 days to appeal.

The release of one document, the Public Summary Document for Atomoxetine from the November 2006 Pharmaceutical Benefits Advisory Committee meeting was not contested, and a copy is attached.

Review rights

You are entitled to seek review of this decision.  Your rights are set out at Attachment C to this letter.

…”  (T10, pp 22–23)

10.     By letter dated 29 January 2009 the officer also notified Eli Lilly of the decision of 28 January 2009 and of its “review rights”.  (T11)

11.     On 13 February 2009 the respondent received from the applicant a letter, dated 11 February 2009, requesting an internal review of the decision of 28 January 2009. (T12)

12.     By letter dated 27 February 2009 Eli Lilly also made a request to the respondent for an internal review of the decision of 28 January 2009.  (T15)

13.     By letter dated 15 April 2009 an officer of the respondent notified the applicant of the internal review decision as follows:

“ …

Decision:

I have decided to vary the decision of the previous delegate as follows:

·     to release additional content in documents 1, 3, 8, 9 and 11;

·     to release parts of document 4;

·     apply the exemptions of s 43(1)(c)(i), s 43(1)(c)(ii) and s 45 to exempt part of document 2, in place of the previous delegate’s decision to exempt that part of the document under s 43(1)(c)(ii) and s 45;

·     apply the exemption of s 45 to exempt document 5 in full, in place of the previous delegate’s decision to do so under s 43(1)(c)(ii) and s 45; and

·     apply the exemptions of s 22, s 43(1)(b), s 43(1)(c)(i) and s 45 to exempt parts of document 7, in place of the previous delegate’s decision to exempt parts of the document under s 22, s 43(1)(c)(i) and s 43(1)(c)(ii) and s 45.

I have decided to affirm the decision of the previous delegate as follows:

·     to release in full document 6; and

·     to release in part document 7.

My reasons for this decision are set out in the Schedule of Documents (the ‘Schedule’) at Attachment B to this letter.  The Schedule sets out each document and details my decision in relation to each document.

Documents subject to third party appeal rights

As I have decided to release material in documents for which a third party has objected to disclosure, I am only able at this time to provide you with access to part of document 7 in which a third party has not objected to release.  I am unable to provide you with access to the other documents until a third party has had an opportunity to exercise their appeal rights.  The Department will keep you informed in relation to any third party appeal on these documents.  A third party has 30 days to appeal to the Administrative Appeals Tribunal.

Review rights

You are entitled to seek review of this decision.  Your rights are set out at Attachment C to this letter.

…”  (T18, pp 65–66)

14.     By letter dated 15 April 2009 the officer also notified Eli Lilly of the abovementioned internal review decision and of its “review rights”. (T19)

15.     On 20 May 2009 the respondent received from Eli Lily a letter, dated 13 May 2009, informing it that Eli Lilly would “not be exercising its further appeal rights” in respect of the internal review decision of 15 April 2009. (T20)

16.     On 3 June 2009 the applicant lodged with the Tribunal, by letter dated 2 June 2009, an application for review of the respondent’s internal review decision of 15 April 2009.  (T1)

The Evidence

17.     In addition to the T Documents the evidence before the Tribunal comprised;

·     bundle of internet documents (Exhibit A1);

·     affidavit of Diana Kay MacDonell, dated 30 October 2009 (including annexures “DKM-1” and “DKM-2”) (Exhibit R1); and

·     the oral evidence of Ms MacDonell.

The evidence of Diana Kay MacDonell

18.     In her affidavit of 30 October 2009 (Exhibit R1) Ms MacDonell affirmed as follows:

“1.   I am the Director of the Pharmaceutical Benefits Advisory Committee (PBAC) Secretariat Section at the Department of Health and Ageing (the Department) and have been in this position since 1999.

2.As a result of my position as Director of the PBAC Secretariat Section at the Department, I also serve as Secretary of the Pharmaceutical Benefits Advisory Committee (PBAC).

3.As Director of the PBAC Secretariat Committee, I am responsible for preparation of the agenda papers for, and minuting of, the meetings of the PBAC and managing the PBAC secretariat.  In this position, I am required to have an in depth knowledge of the operations of the Pharmaceutical Benefits Scheme (PBS) and PBAC processes.  I also am responsible for responding to correspondence addressed to the PBAC or the Department about matters relating to the listing of drugs on the PBS.

4.My affidavit is based on my own knowledge of the subject matter of the application and the documents in issue in this case.  My means of knowledge and sources of information appear on the face of this my affidavit.

EXEMPTIONS

5.The Schedule of Exempt Documents attached to the Respondent’s Statement of Facts and Contentions sets out the grounds upon which the Department seeks to exempt from disclosure documents and parts of documents under the FOI Act.

6.In this affidavit I refer to the documents in issue by the numbers assigned to them in the Schedule of Exempt Documents attached to the Respondent’s Statement of Facts and Contentions.

THE PHARMACEUTICAL BENEFITS SCHEME

7.The Pharmaceutical Benefits Scheme (PBS) is a program of the Australian Government that provides subsidised prescription drugs to residents of Australia.

8.In order to receive a Pharmaceutical Benefit under the PBS, a consumer is prescribed the drug listed in the Schedule of Pharmaceutical Benefits, in accordance with any restriction that may apply to the PBS listing of that drug. The subsidy is automatically applied when the drug is dispensed at a pharmacy and the cost to the patient is the patient co-payment contribution rather than the full cost of the medication.

THE PHARMACEUTICAL BENEFITS ADVISORY COMMITTEE

9.The PBAC is established pursuant to section 100A of the National Health Act 1953 (National Health Act).

10.Section 100B(1) of the National Health Act provides that members of PBAC are appointed by the Minister by written instrument.

11.Section 100A(2) of the National Health Act provides that at least two thirds of the total membership of PBAC are to be selected from the following, with at least one member selected from each of the interests or professions mentioned in paragraphs (a) to (f):

(a) consumers;

(b) health economists;

(c) practising community pharmacists;

(d) general practitioners;

(e) clinical pharmacologists; and

(f) specialists.

12.Section 100A(4) of the National Health Act provides that the remaining members (if any) of the PBAC are to be persons whom the Minister is satisfied have qualifications or experience in a field relevant to the functions of the PBAC and that would enable them to contribute meaningfully to the deliberations of the PBAC.

13.Under section 101A(1) of the National Health Act, PBAC may establish sub-committees, consisting of members with appropriate expertise, to assist it in performing its functions. There are presently two sub-committees that have been established by PBAC to assist it - the Drug Utilisation Sub-Committee and the Economics Sub-Committee.

14.The Drug Utilisation Sub-Committee monitors the patterns and trends of drug use. The Economics Sub-Committee advises on cost-effectiveness policies and evaluates cost-effectiveness aspects of major submissions to the PBAC.

15.The PBAC and its Sub-Committees are serviced by secretariats which are part of the Department.

Functions of the PBAC

16. Section 101(3) of the National Health Act provides that the functions of the PBAC include making recommendations to the Minister for Health about which drugs and medicinal preparations should be available as pharmaceutical benefits, and to advise the Minister about any other matter relating to the PBS which is referred to it by the Minister.

17. Section 101(3A) of the National Health Act provides that for the purpose of deciding whether to recommend to the Minister that a drug or medicinal preparation, or a class of drugs and medicinal preparations, should be made available as pharmaceutical benefits or special pharmaceutical products, the PBAC should give consideration to the effectiveness and cost of therapy involving the use of the drug, preparation or class, including by comparing the effectiveness and cost of that therapy with that of alternative therapies, whether or not involving the use of other drugs or preparations.

Listing on the PBS

18.  A submission to have an item listed on the PBS can be made for any drug or medicinal preparation for any use for which it is registered on the Australian Register of Therapeutic Goods at the time of listing.

19.  The PBAC considers submissions from manufacturers of drug products, medical bodies, health professionals, private individuals and their representatives. However, for new products, it is normally the sponsor or manufacturer who makes a submission for a product to be listed on the PBS as the sponsor or manufacturer usually holds the relevant data required for such a submission.

20.  In making a recommendation about which drugs and/or medicinal preparations should be available as pharmaceutical benefits, the PBAC relies significantly on information provided by the manufacturer or sponsor.

21. In order to assist members of the pharmaceutical industry to prepare submissions for the listing of a drug or medicinal preparation on the PBS and to ensure that the PBAC is provided with relevant information in such submissions, which it can then consider in making its recommendation to the Minister under section 101(3), the PBAC has issued ‘Guidelines for preparing submissions to the Pharmaceutical Benefits Advisory Committee’ (Version 4.3, December 2008) (Guidelines). Annexed to this affidavit and marked 'DKM-1' is a copy of the current Guidelines.  

The documents which are the subject of review in this proceeding

22.  I have considered the documents listed in the Schedule of Exempt Documents which are the subject of review in this proceeding. All of the documents contain information relating to a drug (Eli Lilly drug) which Eli Lilly Pty Ltd (Eli Lilly) proposed to market in Australia.

Documents provided to the PBAC by Eli Lilly Pty Ltd

23. Documents 2, 3 and 7 were provided by Eli Lilly to the PBAC to assist the PBAC make a recommendation to the Minister under section 101(3) of the National Health Act about the listing of the Eli Lilly drug on the PBS.

24. Eli Lilly received document 5 from the Therapeutic Goods Administration and then provided it to PBAC to assist the PBAC make a recommendation to the Minister under section 101(3) of the National Health Act about the listing of the Eli Lilly drug on the PBS.

25. Documents 2, 3, 5 and 7 contain information that is relevant to the consideration by the PBAC as to whether the Eli Lilly drug should be listed on the PBS. The documents contain information relating to the Eli Lilly drug and include information about the matters set out at section 101(3A) and 101(3B) of the National Health Act as well as information of the type required to be provided to the PBAC by the Guidelines.

Documents prepared by the PBAC Secretariat and provided to PBAC

26. Document 1 has been prepared by the PBAC Secretariat and provided to the PBAC to assist it in making a recommendation under section 101(3) of the National Health Act. Document 1 contains a summary, and analysis, of information contained in, and relating to, Eli Lilly's submissions to the PBAC about the possible listing of an Eli Lilly drug on the PBS.

Document prepared by the Pharmaceutical Evaluation Section and provided to PBAC

27. Document 4 has been prepared by the Pharmaceutical Evaluation Section of the Department of Health and Ageing and provided to the PBAC to assist it in making a recommendation to the Minister under section 101(3) of the National Health Act.

28.  The Pharmaceutical Evaluation Section (PES) evaluates PBAC submissions received from sponsors for the listing of drugs on the PBS and provides a commentary on the comparative effectiveness and cost-effectiveness of the proposed drug for consideration by the PBAC.

29.  The PES also provides secretariat support to the Economics Sub-Committee (ESC) and the Drug Utilisation Sub-Committee and produces the minutes of the meetings of these Committees. At its meetings, the ESC considers both submissions from sponsors to the PBAC and the commentaries on these submissions produced by the PES, referred to above. The PES drafts advice, on behalf of the ESC, to the PBAC on each drug, following consideration by the ESC.

30.  Document 4 contains a summary, and analysis, of information contained in, and relating to, Eli Lilly's submissions to PBAC about the possible listing of an Eli Lilly drug on the PBS. In particular, document 4 contains a commentary on the comparative effectiveness and cost-effectiveness of the Eli Lilly drug.

Documents recording the minutes of PBAC meetings

31. Documents 8 and 9 record the minutes of meetings of the PBAC during which the PBAC considered information provided to it in relation to Eli Lilly's application to have an Eli Lilly drug listed on the PBS. Documents 8 and 9 record the deliberations of the PBAC in its consideration of the information before it in relation to Eli Lilly's PBS listing application.

Document prepared by the Economics Sub-Committee and provided to PBAC

32. Document 11 is advice of the ESC, prepared on its behalf by the PES, and provided to the PBAC to assist it in making a recommendation to the Minister under section 101(3) of the National Health Act. Document 11 contains information relating to the cost-effectiveness aspects of Eli Lilly's submission to the PBAC in relation to Eli Lilly's PBS listing application.

…

Documents provided in confidence

38.  Documents that the PBAC receives in submissions and correspondence relating to PBS listing applications is often of a confidential character because they contain inherently confidential scientific, commercial and economic information (Confidential Information) created as a result of research or analysis conducted by sponsoring drug companies in relation to the quality, efficacy and cost effectiveness of particular drugs that are proposed to be listed on the PBS.

39.  Confidential Information is not known to persons other than the sponsor and PBAC.

40.  The PBAC keeps confidential any Confidential Information that it receives by only allowing access to it to officers and agents of the Department who require access to the Confidential Information to perform their lawful duty, or exercise a lawful power or function.

41.  It is a longstanding, consistent and well-known practice of the PBAC to protect Confidential Information from unauthorised disclosure outside of the PBAC. When PBAC members are appointed by the Minister, they are required to sign a ‘Confidentiality Acknowledgment’ (Acknowledgement) in which the member undertakes not to disclose confidential information to any person other than current members of the Committee, without prior approval in writing from the Department.  Annexed to this affidavit and marked 'DKM-2' is the version of the Acknowledgement that PBAC members were required to sign at the time the submission for Strattera was under consideration.

42.  The bottom of every page of document 3 is marked 'CONFIDENTIAL'.

43. The part of document 2 that has been exempted from release under section 45(1) of the FOI Act, as indicated in the Schedule of Exempt Documents, contains a summary of the information in document 3.

44.  The bottom of pages 1-3 of document 7 is marked 'CONFIDENTIAL'.

45.  As parts of documents 2, 3 and 7 contain scientific, commercial and economic information in relation to the quality, efficacy and cost effectiveness of the Eli Lilly drug Stratterra and given that parts of those documents were marked 'CONFIDENTIAL', PBAC treated those parts of documents 2, 3 and 7 as Confidential Information.

46. The parts of documents 1, 4, 5, 8, 9, 10 and 11 which have been found to be exempt from release pursuant to section 45 of the FOI Act as set out in the Schedule of Exempt Documents either refer to information contained in documents 2, 3 or 7 or contain Confidential Information as indicated in letters provided to the Department by Eli Lilly. These letters are reproduced at T7, T9 and T15 of the Tribunal documents filed in this matter.”

19.     The “Confidentiality Acknowledgement” document referred to in para 41 of Ms MacDonell’s affidavit (being Annexure DKM-2 thereto) is in the following terms:

“ CONFIDENTIALITY ACKNOWLEDGEMENT
PHARMACEUTICAL BENEFITS ADVISORY COMMITTEE

I acknowledge that my attention has been drawn to the contents of section 135A of the National Health Act 1953 (Attachment A) and I am aware that I am bound by its provisions in the exercise of my functions as a member of the Pharmaceutical Benefits Advisory Committee.

In particular, I have noted that subsection 135A(1) of the Act requires that:

A person shall not, directly or indirectly, except in the performance of duties, or in the exercise of powers or functions, under this Act or for the purpose of enabling a person to perform functions under the Medicare Australia Act 1973 or the medical indemnity legislation, and while the person is, or after the person ceases to be, an officer, divulge or communicate to any person, any information with respect to the affairs of a third person acquired by the first‑mentioned person in the performance of duties, or in the exercise of powers or functions, under this Act.

As a member of the Pharmaceutical Benefits Advisory Committee I recognise that I am an officer for the purpose of the section, and that information of a third party can include information submitted by a company in support of an application to the Committee.”

20.     In her oral evidence Ms MacDonell provided some elaboration on the contents of her affidavit.  It is, however, unnecessary to refer to that oral evidence in detail in these reasons.

The Relevant Legislation

The National Health Act

21. The National Health Act relevantly provides:

“100A Establishment and membership of the Pharmaceutical Benefits Advisory Committee

(1)There is to be a Committee called the Pharmaceutical Benefits Advisory Committee.

(2)The Committee is to consist of the Chairperson and at least 11, but not more than 17, other members.

(3) Members forming at least ⅔ of the total membership of the Committee are to be selected from the following:

(a)consumers;

(b)health economists;

(c)practising community pharmacists;

(d)general practitioners;

(e)clinical pharmacologists;

(f)specialists;

with at least one member selected from each of the interests or professions mentioned in paragraphs (a) to (f).

(4)The remaining members (if any) of the Committee are to be persons whom the Minister is satisfied have qualifications or experience:

(a)in a field relevant to the functions of the Committee; and

(b)that would enable them to contribute meaningfully to the deliberations of the Committee.

…

100BAppointment etc of members of the Pharmaceutical Benefits Advisory Committee

(1)The members of the Pharmaceutical Benefits Advisory Committee are to be appointed by the Minister by written instrument.

(1A)A person appointed under subsection 100A(3) must be appointed from nominations made by the following bodies:

(a)in respect of paragraph 100A(3)(a)--consumer organisations;

(b) in respect of paragraph 100A(3)(b)--professional associations of health economists;

(c)in respect of paragraph 100A(3)(c)--professional associations of pharmacists;

(d)in respect of paragraph 100A(3)(d)--professional associations of medical practitioners;

(e)in respect of paragraph 100A(3)(e)--professional associations of clinical pharmacologists;

(f)in respect of paragraph 100A(3)(f)--professional associations of specialists;

prescribed by the regulations for the purposes of this subsection.

…

101     Functions of Pharmaceutical Benefits Advisory Committee

Functions relating to drugs and medicinal preparations

(3)The Pharmaceutical Benefits Advisory Committee shall make recommendations to the Minister from time to time as to the drugs and medicinal preparations which it considers should be made available as pharmaceutical benefits or special pharmaceutical products under this Part and shall advise the Minister upon any other matter concerning the operation of this Part referred to it by the Minister.

…

(3A) For the purpose of deciding whether to recommend to the Minister that a drug or medicinal preparation, or a class of drugs and medicinal preparations, be made available as pharmaceutical benefits or special pharmaceutical products under this Part, the Committee shall give consideration to the effectiveness and cost of therapy involving the use of the drug, preparation or class, including by comparing the effectiveness and cost of that therapy with that of alternative therapies, whether or not involving the use of other drugs or preparations.

…

101A   Sub-committees of the Pharmaceutical Benefits Advisory Committee

(1)       The Pharmaceutical Benefits Advisory Committee:

(a)may establish such sub‑committees as it thinks fit to assist it in performing its functions; and

(b)shall, if the Minister so requires in writing, establish a sub‑committee to assist the Committee in advising the Minister on a particular matter referred to it by the Minister under subsection 101(3) or (4B).

(2)A sub‑committee shall consist of the following persons (whether or not members of the Committee):

(a)persons appointed by the Committee as members of the sub‑committee;

(b)persons nominated by the Minister as members of the sub‑committee.

(3)A person shall not be appointed by the Committee, or nominated by the Minister, as a member of a sub‑committee unless the person has special qualifications or experience in relation to the matter referred to the sub‑committee.

…

135A   Officers to observe secrecy

(1)A person shall not, directly or indirectly, except in the performance of duties, or in the exercise of powers or functions, under this Act or for the purpose of enabling a person to perform functions under the Medicare Australia Act 1973 or the medical indemnity legislation, and while the person is, or after the person ceases to be, an officer, divulge or communicate to any person, any information with respect to the affairs of a third person acquired by the first‑mentioned person in the performance of duties, or in the exercise of powers or functions, under this Act.

Penalty:  $5,000 or imprisonment for 2 years, or both.

…

(24)     In this section:

…

officer means a person performing duties, or exercising powers or functions under, or in relation to, this Act.

…”

The FOI Act

22. The object of the FOI Act is set out in s 3 which relevantly provides:

“(1)    The object of this Act is to extend as far as possible the right of the Australian community to access to information in the possession of the Government of the Commonwealth by:

…

(b)    creating a general right of access to information in documentary form in the possession of Ministers, departments and public authorities, limited only by exceptions and exemptions necessary for the protection of essential public interests and the private and business affairs of persons in respect of whom information is collected and held by departments and public authorities; …

…

(2)It is the intention of the Parliament that the provisions of this Act shall be interpreted so as to further the object set out in subsection (1) and that any discretions conferred by this Act shall be exercised as far as possible so as to facilitate and promote, promptly and at the lowest reasonable cost, the disclosure of information.”

23. Section 4(1) relevantly provides:

“ (1)    In this Act, unless the contrary intention appears:

…

agency means a Department, a prescribed authority or an eligible case manager.

…

Department means a Department of the Australian Public Service that corresponds to a Department of State of the Commonwealth …

…

document of an agency or document of the agency means a document in the possession of an agency, or in the possession of the agency concerned, as the case requires, whether created in the agency or received in the agency.

…

exempt document means:

(a)    a document which, by virtue of a provision of Part IV, is an exempt document;

…

exempt matter means matter the inclusion of which in a document causes the document to be an exempt document.

...”

24. Section 11 provides:

“(1)    Subject to this Act, every person has a legally enforceable right to obtain access in accordance with this Act to:

(a)    a document of an agency, other than an exempt document; or

(b)    an official document of a Minister, other than an exempt document.

(2)    Subject to this Act, a person's right of access is not affected by:

(a)    any reasons the person gives for seeking access; or

(b)    the agency's or Minister's belief as to what are his or her reasons for seeking access.”

25. Part IV of the FOI Act contains provisions relating to various categories of “exempt documents”. The relevant provisions of Part IV are as follows:

“ 38     Documents to which secrecy provisions of enactments apply

(1)Subject to subsection (1A), a document is an exempt document if:

(a)  disclosure of the document, or information contained in the document, is prohibited under a provision of an enactment; and

(b)  either:

(i)that provision is specified in Schedule 3; or

(ii)this section is expressly applied to the document, or information, by that provision, or by another provision of that or any other enactment.

(1A)A person's right of access to a document under section 11 or 22 is not affected merely because the document is an exempt document under subsection (1) of this section if disclosure of the document, or information contained in the document, to that person is not prohibited by the enactment concerned or any other enactment.

…”

“43      Documents relating to business affairs etc

(1)A document is an exempt document if its disclosure under this Act would disclose:

(a)  trade secrets;

(b)  any other information having a commercial value that would be, or could reasonably be expected to be, destroyed or diminished if the information were disclosed; or

(c)  information (other than trade secrets or information to which paragraph (b) applies) concerning a person in respect of his or her business or professional affairs or concerning the business, commercial or financial affairs of an organization or undertaking, being information:

(i)the disclosure of which would, or could reasonably be expected to, unreasonably affect that person adversely in respect of his or her lawful business or professional affairs or that organization or undertaking in respect of its lawful business, commercial or financial affairs; …

…”

“ 45     Documents containing material obtained in confidence

(1)A document is an exempt document if its disclosure under this Act would found an action, by a person (other than an agency or the Commonwealth), for breach of confidence.

…”

26. Part VI of the FOI Act, which deals with review of decisions under that Act, contains (inter alia) the following relevant provisions in respect of review by the Tribunal:

“ 58     Powers of Tribunal

(1)Subject to this section, in proceedings under this Part, the Tribunal has power, in addition to any other power, to review any decision that has been made by an agency or Minister in respect of the request and to decide any matter in relation to the request that, under this Act, could have been or could be decided by an agency or Minister, and any decision of the Tribunal under this section has the same effect as a decision of the agency or Minister.

(2)Where, in proceedings under this Act, it is established that a document is an exempt document, the Tribunal does not have power to decide that access to the document, so far as it contains exempt matter, is to be granted.

…”

“ 61Onus

(1)Subject to subsection (2), in proceedings under this Part, the agency or Minister to which or to whom the request was made has the onus of establishing that a decision given in respect of the request was justified or that the Tribunal should give a decision adverse to the applicant.

…”

27. Various provisions of enactments are specified in Schedule 3 to the FOI Act, including:

“ National Health Act 1953, subsections 135A(1), (4) and (9)”.

The Relevant Documents

28. The documents, the subject of this application for review, are referred to as documents 1, 2, 3, 4, 5, 7, 8, 9 and 11. The respondent submitted that each of those documents is, by virtue of s 38(1) of the FOI Act, wholly an exempt document. Alternatively, the respondent submitted that document 5 is, by virtue of s 45(1) of the FOI Act, wholly an exempt document, and that each of documents 1, 2, 3, 4, 7, 8, 9 and 11 is, by virtue of s 43(1)(b), s 43(1)(c)(i) and s 45(1), an exempt document because it includes exempt matter pursuant to those provisions.

29. The abovementioned documents have been produced by the respondent for inspection by the Tribunal in accordance with s 64(1) of the FOI Act. Having inspected those documents, and having had regard to the evidence of Ms MacDonell, the Tribunal considers that those documents are appropriately described as follows.

Document 1

30.     This document (comprising 8 pages) was prepared by the Pharmaceutical Benefits Advisory Committee (“PBAC”) Secretariat and contains a summary and an analysis of Eli Lilly’s submission to the PBAC for the listing of “Strattera” on the PBS, and was provided to the PBAC for consideration by the PBAC at its November 2006 meeting.

Document 2

31.     This document (comprising 2 pages) is a letter, dated 17 August 2006, from Eli Lilly to the Secretary of the PBAC under cover of which Eli Lilly’s abovementioned submission was forwarded to the PBAC.

Document 3

32.     This document (comprising 78 pages) contains Eli Lilly’s abovementioned submission to the PBAC dated August 2006.

Document 4

33.     This document (comprising 65 pages) contains a commentary on, including an evaluation of, a previous submission to the PBAC by Eli Lilly for the listing of “Strattera” on the PBS, prepared by the respondent’s Pharmaceutical Evaluation Section and provided to the PBAC for consideration by the PBAC at its July 2006 meeting.

Document 5

34.     This document (comprising 2 pages) is a letter, dated 11 August 2006, from the Drug Safety and Evaluation Branch of Therapeutic Goods Administration (“TGA”) within the respondent to Eli Lilly regarding a TGA safety review of drugs used to treat Attention Deficit Hyperactivity Disorder.

Document 7

35.     This document (comprising 7 pages) is an e-mail, dated 25 October 2006, from Eli Lilly to the PBAC including an attachment headed “Response to the Pre-PBAC Advice” containing comments for the consideration of the PBAC in relation to Eli Lilly’s abovementioned submission.

Document 8

36.     This document (comprising 2 pages) contains the short minutes of the November 2006 meeting of the PBAC at which Eli Lilly’s abovementioned submission was considered.

Document 9

37.     This document (comprising 7 pages) contains the full minutes of the November 2006 meeting of the PBAC at which Eli Lilly’s abovementioned submission was considered.

Document 11

38.     This document (comprising 11 pages) contains the advice of the Economics Sub-Committee of the PBAC to the PBAC in relation to a previous submission to the PBAC by Eli Lilly for the listing of “Strattera” on the PBS for consideration by the PBAC at its July 2006 meeting.

Analysis

39. Pursuant to s 38(1) of the FOI Act a document is an “exempt document”, within the meaning of the FOI Act, if (relevantly):

“(a)     disclosure of the document, or information contained in the document, is prohibited under a provision of an enactment; and

(b)     …

(i)      that provision is specified in Schedule 3; …

…”

40. Section 135A(1) of the National Health Act is a “provision of an enactment” (within the meaning of s 38(1)(a) of the FOI Act) which is “specified in Schedule 3” to the FOI Act (for the purposes of s 38(1)(b)(i) of the FOI Act). Accordingly, a document, the disclosure of which, or the disclosure of information contained in which, is prohibited under section 135A(1) of the National Health Act, is an “exempt document”, for the purposes of the FOI Act, by virtue of s 38(1) of the FOI Act.

41. Section 135A(1) of the National Health Act prohibits a person (being an “officer” or a former “officer” as defined in subs (24)) from, directly or indirectly, divulging or communicating to any person:

“ any information with respect to the affairs of a third person acquired by the first-mentioned person in the performance of duties, or in the exercise of powers or functions, under [the National Health] Act;

except in the performance of duties, or in the exercise of powers or functions, under the National Health Act or for the purpose of enabling a person to perform functions under other specified Acts (none of which is relevant in this case).

Do the relevant documents (or any of them) contain “information with respect to the affairs of a third person” within the meaning of s 135A(1) of the National Health Act?

42.     Having inspected the relevant documents (as described in paragraphs 30–38 above), the Tribunal is satisfied that each of those documents contains information relating to the drug “Strattera” and, in particular, to the submission by Eli Lilly to the PBAC for the listing of “Strattera” on the PBS.  Having regard to the fact that “Strattera” has at all material times been marketed in Australia by Eli Lilly, the Tribunal is satisfied, and finds, that each of the relevant documents contains information with respect to the business or commercial affairs of Eli Lilly.

43. The Tribunal concludes, therefore, that each of the relevant documents contains “information with respect to the affairs of a third person”, namely, Eli Lilly, within the meaning of s 135A(1) of the National Health Act: see Re Advocacy of the Aged Association Inc and Department of Health, Housing and Community Services [1992] AATA 319 (at para 32); Re Caruth and Department of Health, Housing, Local Government and Community Services [1993] AATA 187 (at para 83).

Was the abovementioned information with respect to the affairs of Eli Lilly, contained in each of the relevant documents, acquired “in the performance of duties, or in the exercise of powers or functions, under” the National Health Act?

44. On the basis of the evidence of Ms MacDonell – in particular, paras 23–32 of her affidavit of 30 October 2009 (Exhibit R1) set out in paragraph 18 above – the Tribunal finds that each of the relevant documents was provided to the PBAC for the purpose of assisting it in making a recommendation to the Minister for Health under s 101(3) of the National Health Act regarding the listing of “Strattera” on the PBS.

45. The PBAC is established pursuant to s 100A of the National Health Act, and each of the members of the PBAC is appointed pursuant to s 100B of that Act. The functions of the PBAC are prescribed by s 101 of the National Health Act and relevantly include, pursuant to s 101(3), the making of “recommendations to the Minister from time to time as to the drugs and medicinal preparations which it considers should be made available as pharmaceutical benefits” under the PBS. It follows that each of the members of the PBAC is an “officer” (as defined in s 135A(24) of the National Health Act) for the purposes of s 135A(1) of the National Health Act.

46. On the basis of the abovementioned evidence of Ms MacDonell, the Tribunal is satisfied, and finds, that the information with respect to the affairs of Eli Lilly contained in each of the relevant documents was acquired by each of the members of the PBAC “in the performance of duties, or in the exercise of powers or functions, under” the National Health Act (within the meaning of s 135A(1) of that Act), namely, in the exercise of the function of the PBAC under s 101(3) of the National Health Act.

Section 135A(1) of the National Health Act applies to each of the relevant documents

47. As mentioned in paragraphs 42–46 above, the Tribunal has found that each of the relevant documents contains “information with respect to the affairs of a third person” which was “acquired …. in the performance of duties, or in the exercise of powers or functions, under” the National Health Act, within the meaning of s 135A(1) of that Act. The Tribunal has also found that each of the members of the PBAC who acquired that information “in the performance of duties, or in the exercise of powers or functions, under” the National Health Act is an “officer” for the purposes of s 135A(1) of that Act. It follows that each of those members of the PBAC is prohibited by s 135A(1) of the National Health Act from “directly or indirectly” disclosing that information, “except in the performance of duties, or in the exercise of powers or functions, under this Act or for the purpose of enabling a person to perform functions under the Medicare Australia Act 1973 or the medical indemnity legislation”. Disclosure of that information by a member of the PBAC, otherwise than in the performance of duties, or in the exercise of powers or functions, under the National Health Act or for the other abovementioned statutory purposes, is, therefore, prohibited by s 135A(1) of the National Health Act. Hence, disclosure of that information by the respondent under the FOI Act is likewise prohibited by s 135A(1) of the National Health Act.

48. The Tribunal notes that s 135A of the National Health Act contains various exceptions to the prohibition in s 135A(1) – see subss (2), (3), (5), (5B), (5C), (6), (7) and (8) – but the Tribunal is satisfied that none of those exceptions applies in this case.

49. The Tribunal concludes, therefore, that disclosure, under the FOI Act, of information contained in any of the relevant documents is prohibited by s 135A(1) of the National Health Act.

Each of the relevant documents is an exempt document

50.     It follows from:

· the Tribunal’s finding that disclosure, under the FOI Act, of information contained in any of the relevant documents is prohibited under s 135A(1) of the National Health Act; and

· the specification of s 135A(1) of the National Health Act in Schedule 3 to the FOI Act;

that each of the relevant documents is an exempt document by virtue of s 38(1) of the FOI Act.

51. The Tribunal notes that subs (1A) of s 38 of the FOI Act, to which s 38(1) is subject, is not applicable in this case because disclosure, under the FOI Act, of information contained in any of the relevant documents to the applicant is prohibited by s 135A(1) of the National Health Act.

Conclusion

52. Having concluded that each of the relevant documents is an exempt document by virtue of s 38(1) of the FOI Act, it is unnecessary for the Tribunal to consider whether each of those documents is an exempt document by virtue of any other provision of Part IV of the FOI Act.

53. It also follows from the conclusion that each of the relevant documents is an exempt document that, pursuant to s 58(2) of the FOI Act, the Tribunal does not have power to decide that access to any of those documents, so far as each document contains exempt matter, is to be granted.

Decision

54. For the above reasons the Tribunal varies the decision under review by determining that each of documents 1, 2, 3, 4, 5, 7, 8, 9 and 11 is an exempt document by virtue of s 38(1) of the FOI Act.

I certify that the 54 preceding paragraphs are a true copy of the reasons for the decision herein of Deputy President S D Hotop and Professor G A R Johnston, Member

Signed:         ...............[sgd D Brodie]........................

Associate

Date of Hearing  15 April 2010
Date of Decision  7 May 2010
Representative of the Applicant      Self-represented
Counsel for the Respondent            Mr A Chand
Solicitor for the Respondent            Australian Government Solicitor