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Reference: FOI 4150
Mr Rex Banner
By Em
ail: xxxxxxxxxxxxxxxxxxxxxxxxx@xxxxxxxxxxx.xxx.xx
Dear Mr Banner,
Decision on your Freedom of Information Request
I refer to your request of 12 December 2022, to the Department of Health and Aged
Care (the department), seeking access under the
Freedom of Information Act 1982 (Cth)
(FOI Act) to:
I am writing to request access to the evidence of efficacy of Escitalopram, as
required for listing on the Pharmaceutical Benefits Scheme (PBS).
Please provide all relevant information, including any studies, clinical trials, or
other evidence that has been used to evaluate the efficacy of Escitalopram for
inclusion on the PBS.
I am authorised under subsection 23(1) of the FOI Act to make decisions in relation to
Freedom of Information requests. I am writing to notify you of my decision on your
request.
FOI decision
I have identified 24 documents that are relevant to your request. These documents
were in the possession of the department when your request was received.
I have decided to:
• give access to 10 documents in full, and
• give access to 14 documents in part, subject to the deletion of irrelevant or
exempt material.
A schedule setting out the documents relevant to your request, with my decision in
relation to those documents, is at
ATTACHMENT A.
My reasons for not providing access to material that has been deleted from the
documents are set o
ut in ATTACHMENT B.
GPO Box 9848 Canberra ACT 2601
- www.health.gov.au
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Legislative provisions
The FOI Act, including the provisions referred to in my decision, are available on the
Federal Register of Legislation websit
e: www.legislation.gov.au/Series/C2004A02562.
Your review rights
I have set out your review rig
hts at ATTACHMENT C.
Publication
Where I have decided to release documents to you, the department may also publish
the released material on its Disclosure Log. The department will not publish personal
or business affairs information where it would be unreasonable to do so.
For your reference the department’s Disclosure Log can be found at:
www.health.gov.au/resources/foi-disclosure-log.
Contacts
If you require clarification of any matters discussed in this letter you can contact the
FOI Section on (02) 6289 1666 or at
xxx@xxxxxx.xxx.xx.
Yours sincerely
Natasha Ploenges
Assistant Secretary
Office of Health Technology Assessment
6 March 2023
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ATTACHMENT A.
SCHEDULE OF DOCUMENTS
FOI 4150
Doc
Pages
Date
Description
Decision on access1 Relevant
provision/
s of FOI
Act
1
314
25/09/2009 March 2007 Ratified
RI
22
(3 pages
Consolidated Minutes
released)
2
389
31/07/2009 March 2008 Ratified
REI
22, 38
(8 Pages
consolidated minutes
Released)
3
183
17/09/2008 September 2003 ratified
RI
22
consolidated minutes
(4 pages
released)
4
96
08/05/2018 September 2003 main
RI
22
(48 pages
submission body in relation to
released)
document 3.
5
60
30/10/2006 March 2007 main submission
RI
22
body in relation to document 1
(27 pages
released)
6
178
28/10/2007 March 2008 main submission
REI
22, 38,
(159
body - Clinical Evaluation For
pages
The Main Indication in relation
47E(d)
released)
to document 2
7
113
28/10/2007 March 2008 main submission
REI
22, 38,
(88 Pages
body - Clinical Evaluation For
released)
The Main Indication in relation
47E(d)
to document 2
8
28
29/09/2007 Attachment 1 to main
R
submission body document 6
and 7. Australian Product
Information for Lexapro
1 R = Release in full, RE = Release with exempt information deleted, RI = Release with irrelevant
information deleted, RE I= Release with exempt and irrelevant information deleted
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9
42
24/10/2007 Attachment 2 to main
R
submission body document 6.
“Epidemiology of generalised
anxiety disorder (GAD)”
10
137
24/10/2007 Attachment 4 to main
REI
22, 38,
submission body document 6.
47E(d)
“Details of the Literature
Searches Conducted for
Escitalopram GAD Submission”
11
8
24/10/2007 Attachment 5 to main
R
submission body document 6.
“Detailed assessment of the
measures taken by
investigators to minimise bias
in the randomised trials
(addendum to Section B.3)”
12
51
24/10/2007 Attachment 6 to main
RE
38
submission body document 6.
“Meta-Analysis Strategy and
Results for GAD”
13
35
28/10/2007 Attachment 7 to main
R
submission body document 6.
“Secondary outcome results
for the individual studies
(Section B.6.3 of the
submission)”
14
35
24/10/2007 Attachment 9 to main
R
submission body document 6.
“Additional Statistical
Analyses”
15
32
24/10/2007 Attachment 10 to main
R
submission body document 6.
“GAD and co-morbidities
clinical evidence”
16
42
24/10/2007 Attachment 2 to main
R
submission body document 7.
“Epidemiology of social anxiety
disorder (SAD) or social
phobia”
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17
53
24/10/2007 Attachment 4 to main
RE
38, 47E(d)
submission body document 7.
“Details of the literature
searches conducted”
18
33
24/10/2007 Attachment 5 to main
R
47E(d)
submission body document 7.
“Meta-Analysis Strategy and
Results for SAD”
19
17
24/10/2007 Attachment 6 to main
R
submission body document 7.
“Secondary outcome results
for the individual studies
(section B.6.4 of the
submission)”
20
16
28/10/2007 Attachment 8 to main
R
submission body document 7.
“SAD and co-morbidities
clinical evidence”
21
73
12/01/2023 Appendix 4 “Study 9903” for
RI
22
document 4
22
76
12/01/2023 Appendix 5 “Study 99022” for
RI
22
document 4.
23
13
12/01/2023 Appendix 7 “Escitalopram
RI
22
(8 Pages
Flexible Dose Study” for
released)
document 4
24
35
12/01/2023 Appendix 8 “Clinical Expert
RI
22
Report” for document 4.
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ATTACHMENT B.
REASONS FOR DECISION
FOI 4150
1.
Material taken into account
In making my decision, I had regard to the following:
• the FOI Act
• guidelines issued by the Australian Information Commissioner under
section 93A of the FOI Act (FOI Guidelines)
• the terms of your FOI request as outlined above
• submissions from third parties consulted about documents which contain
information concerning them
• the content of the documents sought, and
• advice from departmental officers with responsibility for matters relating to
the documents sought.
2.
Finding of facts and reasons for decision
My findings of fact and reasons for deciding that the exemptions identified in the
schedule of documents apply to the parts of documents are set out below.
3.
Section 38 - Documents to which secrecy provisions of enactments apply
Section 38 of the FOI Act provides that a document is an exempt document if
disclosure of the document, or information contained in the document, is prohibited
under a provision of an enactment; and that provision is specified in Schedule 3 of the
FOI Act.
Relevantly, Schedule 3 of the FOI Act specifies the following secrecy provision the
National Health Act 1953, subsections 135A(1), (4) and (9).
I am satisfied that the information contained in the parts of the documents marked
‘s38’ are subject to the secrecy provisions contained in the
National Health Act 1953,
subsections 135A(1), (4) and (9).
I am further satisfied that subsections 38(1A) and 38(2) of the FOI Act do not apply in
this instance are not relevant to my decision.
For the reasons outlined above, I have decided that the parts of the documents marked
‘
s38’ are exempt from disclosure under section 38 of the FOI Act.
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4.
Section 47E - Documents affecting certain operations of agencies
Section 47E of the FOI Act provides that a document is conditionally exempt if its
disclosure would, or could reasonably be expected to, do any of the following:
(a) prejudice the effectiveness of procedures or methods for the conduct of tests,
examinations or audits by an agency;
(b) prejudice the attainment of the objects of particular tests, examinations or
audits conducted or to be conducted by an agency;
(c) have a substantial adverse effect on the management or assessment of
personnel by the Commonwealth or by an agency;
(d) have a substantial adverse effect on the proper and efficient conduct of the
operations of an agency.
Paragraph 6.120 of the FOI Guidelines states:
An agency’s operations may not be substantially adversely affected if the disclosure
would, or could reasonably be expected to lead to a change in the agency’s processes
that would enable those processes to be more efficient. For example, in Re Scholes and
Australian Federal Police [1996] AATA 347, the AAT found that the disclosure of
particular documents could enhance the efficiency of the Australian Federal Police as it
could lead to an improvement of its investigation process.
Paragraph 6.123 of the FOI Guidelines states that the predicted effect must bear on the
department’s ‘proper and efficient’ operations, that is, the department is undertaking
its expected activities in an expected manner. Where disclosure of the documents
reveals unlawful activities or inefficiencies, this element of the conditional exemption
will not be met and the conditional exemption will not apply.
I am satisfied that the parts of the documents marked ‘s47E(d)’ contains information
which, if disclosed, would or could reasonably be expected to, have a substantial and
an unreasonable effect on the department’s proper and efficient operations. These are
operational activities that are being undertaken in an expected and lawful manner, and
would not reveal inefficiencies in the way in which the department conducts those
operational activities.
For the reasons outlined above, I have decided that the parts of the documents marked
‘s47E’ are conditionally exempt from disclosure under section 47E of the FOI Act.
Where a document is found to be conditionally exempt, the department must give
access to that document unless access to the document at this time would, on balance,
be contrary to the public interest. I have addressed the public interest considerations
below.
5.
Disclosure is not in the public interest
Pursuant to subsection 11A(5) of the FOI Act, the department must give access to
conditionally exempt documents unless access to the documents at that time would,
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on balance, be contrary to the public interest. I have therefore considered whether
disclosure of the document/s would be contrary to the public interest.
Paragraph 6.5 of the FOI Guidelines states:
The public interest test is considered to be:
• something that is of serious concern or benefit to the public, not merely
of individual interest
• not something of interest to the public, but in the interest of the public
• not a static concept, where it lies in a particular matter will often depend
on a balancing of interests
• necessarily broad and non-specific and
• relates to matters of common concern or relevance to all members of the
public, or a substantial section of the public.
Factors favouring disclosure
Section 11B of the FOI Act provides that factors favouring access to documents in the
public interest include whether access to the documents would do any of the
following:
• promote the objects of the FOI Act (including all matters set out in sections 3
and 3A)
• inform debate on a matter of public importance
• promote effective oversight of public expenditure, or
• allow a person to access his or her own personal information.
Having regard to the above, I consider that disclosure of the conditionally exempt
information at this time:
• would provide access to documents held by an agency of the Commonwealth
which would promote the objects of the FOI Act by providing the Australian
community with access to information held by the Australian Government.
• would not inform debate on a matter of public importance
Factors weighing against disclosure
I consider that the following public interest factors weigh against disclosure of the
conditionally exempt information at this time, on the basis that disclosure:
s47E(d)
• could reasonably have a substantial adverse effect on the proper and efficient
conduct of the operations of an agency.
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In making my decision, I have not taken into account any of the irrelevant factors set
out in subsection 11B(4) of the FOI Act, which are:
(a) access to the document could result in embarrassment to the
Commonwealth Government, or cause a loss of confidence in the
Commonwealth Government;
(b) access to the document could result in any person misinterpreting or
misunderstanding the document;
(c) the author of the document was (or is) of high seniority in the agency to
which the request for access to the document was made;
(d) access to the document could result in confusion or unnecessary debate.
Conclusion
For the reasons set out above, after weighing all public interest factors for and against
disclosure, I have decided that, on balance, disclosure of the conditionally exempt
information would be contrary to the public interest. I am satisfied that the benefit to
the public resulting from disclosure is outweighed by the benefit to the public of
withholding the information.
6.
Section 22 – deletion of irrelevant material
Section 22 of the FOI Act applies to documents containing exempt material
(subparagraph (1)(a)(i)) and irrelevant information (subparagraph (1)(a)(ii)) and
allows an agency to delete such material from a document.
I have deleted material in the documents which can reasonably be regarded as
irrelevant to your request and prepared an edited copy for release. This information
has been marked ‘s22’ in the documents released to you.
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ATTACHMENT C.
YOUR REVIEW RIGHTS
If you are dissatisfied with my decision, you may apply for a review.
Internal review
You can request internal review within 30 days of you receiving this decision. An
internal review will be conducted by a different officer from the original
decision-maker.
No particular form is required to apply for review although it will assist your case to
set out the grounds on which you believe that the original decision should be changed.
Applications for internal review can be made by:
Email:
xxx@xxxxxx.xxx.xx
Mail:
FOI Unit (MDP 516)
Department of Health
GPO Box 9848
CANBERRA ACT 2601
If you choose to seek an internal review, you will also have a right to apply for
Information Commissioner review (IC review) of the internal review decision once it
has been provided to you.
Information Commissioner (IC) review or complaint
You also have the right to seek IC review of this decision. For FOI applicants, an
application for IC review must be made in writing within 60 days of the decision. For
third parties who object to disclosure of their information, an application for IC review
must be made in writing within 30 days of the decision.
If you are not satisfied with the way we have handled your FOI request, you can lodge
a complaint with the OAIC. However, the OAIC suggests that complaints are made
to the agency in the first instance.
While there is no particular form required to make a complaint to the OAIC, the
complaint should be in writing and set out the reasons for why you are dissatisfied
with the way your request was processed. It should also identify the Department of
Health and Aged Care as the agency about which you are complaining.
You can make an IC review application or make an FOI complaint in one of the
following ways:
• online at www.oaic.gov.au/freedom-of-information/reviews-and-
complaints/
• via email to xxxxx@xxxx.xxx.xx
• by mail to GPO Box 5218 Sydney NSW 2001, or
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• by fax to 02 9284 9666.
More information about the Information Commissioner reviews and complaints is
available on the OAIC website here: www.oaic.gov.au/freedom-of-information/foi-
review-process.
Complaint
If you are dissatisfied with action taken by the department, you may also make a
complaint directly to the department.
Complaints to the department are covered by the department’s privacy policy. A form
for lodging a complaint directly to the department is available on the department’s
website her
e: www.health.gov.au/about-us/contact-us/complaints
