FOI reference: FOI 5155
Mr Ian Saunders
By email: xxxxxxxxxxxxxxxxxxxxxxxxxx@xxxxxxxxxxx.xxx.xx

Dear Mr Saunders,
Decision on your Freedom of Information Request
I refer to your request of 22 May 2024 to the Department of Health and Aged Care (the
department), seeking access under the Freedom of Information Act 1982 (Cth) (FOI Act)
to:
All documents associated with MSAC 1530 - Purified human alpha1-proteinase
inhibitor (A1-PI) for the treatment of alpha1-proteinase inhibitor deficiency, leading to
chronic obstructive pulmonary disease (COPD).
Clarification of scope of request
On 29 May 2024 you clarified the scope of your request as follows:

The following documents associated with MSAC 1530 - Purified human alpha1-
proteinase inhibitor (A1-PI) for the treatment of alpha1-proteinase inhibitor
deficiency, leading to chronic obstructive pulmonary disease (COPD):
1. Grifols and CSL submissions
2. The full Assessment Report related to the MSAC submission (around 2017 -
2018)
3. The economic analysis carried out relating to cost/benefit of augmentation
therapy
4. The full (unredacted) public report "1530 - Purified human alpha1-proteinase
inhibitor (A1-PI) for the treatment of alpha1-proteinase inhibitor deficiency,
leading to chronic obstructive pulmonary disease (COPD) from 2018
Extensions of Time
Your request was originally due on 21 June 2024. On 13 June 2024 the department
informed you that consultation with third parties would be necessary. Under the FOI
Act this provided the department with an additional 30 days to process this request.
Your request subsequently became due on 21 July 2024.

GPO Box 9848 Canberra ACT 2601 - www.health.gov.au

link to page 4 link to page 5 link to page 15 - 2 -
On 18 July 2024, the department contacted you seeking your agreement to extend your
request under s15AA of the FOI Act by 21 calendar days. On same date you agreed to
this extension, meaning your request then became due on 11 August 2024.
On 2 August 2024 the department contacted you seeking your agreement to further
extend your request under s15AA. We requested an extension of 9 calendar days. On
same date you agreed to this extension, meaning your request then became due on 20
August 2024.
FOI decision
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.
I have identified nine documents comprising of seven primary documents and two
attachments 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 nine  documents  in part, subject to the deletion of
exempt and irrelevant 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 out in ATTACHMENT B.
You were informed on 13 June 2024  that consultation with third parties would be
necessary. A contention has been made that documents 2 – 7 should be exempt in full
from disclosure. My decision has been to grant access to that material in part. As such,
the relevant third parties have review rights under the FOI Act.
As a result, I am unable to provide you with access to these documents until the third-
party review rights have expired.
Legislative provisions
The FOI Act, including the provisions referred to in my decision, is available on the
Federal Register of Legislation website: www.legislation.gov.au/Series/C2004A02562.
The Privacy Act 1988 (Cth) (Privacy Act), can also be accessed from the Federal
Register of Legislation website here: www.legislation.gov.au/Series/C2004A03712.
Your review rights
I have set out your review rights at ATTACHMENT C.

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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

Caroline Turnour
Assistant Secretary
Office of Health Technology Assessment Branch
19 August 2024

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ATTACHMENT A.
SCHEDULE OF DOCUMENTS
FOI-5155

Relevant
Document  Pages
Date
Description
Decision on
provision
access
s of FOI
Act
Release with
1
3
18/09/2018
1530 pre-ESC response
exempt
s45
information
s47G
deleted.
1.1
2
18/09/2018  1530 Attachment to pre-ESC
response in Document 1
Release in full.

1530 pre-ESC response
Release with
2
1
18/09/2018

exempt
s47G
Third-party review rights.
information
deleted.
1530 – Pre-MSAC response
Release with
exempt and
s22
3
12
21/11/2018
including emails
s45

irrelevant
s47F
Third-party review rights.
information
deleted.
s47G
1530 – Pre-MSAC response
attachment in Document 3. –
Release with
3.1
48
13/11/2018
Biochemical verification of
exempt
s45
tobacco use and cessation
information
publication
deleted.
1530 – Final Contracted
Assessment Report – August
Release with
s45
4
218  31/08/2018
2018
exempt
s47(1)(b)

information
s47F
Third-party review rights.
deleted.
s47G
1530 - Final Public Summary
Release with
5
18
17/01/2019  Document – November 2018
exempt

information
s47(1)(b)
Third-party review rights.
deleted.
1530 – Assessment Group
additional analyses-Annex to
Release with
s45
6
11
15/11/2018
Section D
exempt
s47(1)(b)

information
s47G
Third-party review rights.
deleted.
1530 – Assessment Group
Release with
7
2
19/11/2018
further sensitivity analyses
exempt

information
s47(1)(b)
Third-party review rights.
deleted.

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ATTACHMENT B.
REASONS FOR DECISION
FOI-5155
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 22 – deletion of irrelevant and exempt 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.
The documents contain the names and telephone numbers of Department of Health
employees. When your request was acknowledged, we notified you that this material
would be considered irrelevant to the scope of your request unless you told us that
you were seeking access to that material. On the basis that you did not notify us
otherwise, this information has been deleted under section 22 of the FOI Act as
outlined above.
The pages of document 3 marked ‘s22’ are irrelevant as they contain correspondence
relating to administrative issues, namely the receipt of MSAC submissions. As you
have not requested access to these documents, the department considers this irrelevant
to the scope of your request.
As I have decided that some of the information in the documents released to you is
exempt from disclosure, I have prepared an edited copy of the document(s) by deleting
the exempt information from the documents under section 22  of the FOI Act as
outlined above.

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4.  Section 45 - Documents containing material obtained in confidence
Section  45  of the FOI Act provides that a document is an exempt document if its
disclosure would found an action by a person for breach of confidence.
Paragraph 5.189 of the FOI Guidelines states that to found an action for breach of
confidence, the following five criteria must be satisfied in relation to the information:
•  it must be specifically identified
•  it must have the necessary quality of confidentiality
•  it must have been communicated and received on the basis of a mutual
understanding of confidence
•  it must have been disclosed or threatened to be disclosed, without authority
•  unauthorised disclosure of the information has or will cause detriment
I am satisfied that the parts of the documents marked ‘s45’ consist of information:
•  that is specifically identified within the documents as being confidential in
nature
•  that has the quality of confidentiality, is only known to a limited group and is
not common knowledge nor in the public domain
•  that was communicated and received on the basis of mutual understanding of
confidence, and that this mutual understanding exists at the time of the
communication
•  in circumstances in which there is a contractual obligation of confidence
between the department and an affected third party
•  in circumstances in which disclosure of the information will be without the
authority of the affected third party, and
•  in circumstances where disclosure of the information would cause detriment to
the party who provided the confidential information to the department. The
detriment in this instance would involve financial loss  to the affected third
party.
Documents 1, 3, 3.1 and 6  contains information that was communicated to the
department in confidence. The release of the information marked s45 would
reasonably constitute a breach of confidence. The information, if released, would also
undermine the third parties’ competitive advantage and allow competitors to gain an
unfair advantage in several global markets.
For the reasons outlined above, I have decided that the parts of the documents marked
‘s45’ are exempt from disclosure under section 45 of the FOI Act.

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5.  Section 47 - Documents disclosing trade secrets or commercially valuable
information
Subsection 47(1) of the FOI Act provides that a document is an exempt document if its
disclosure would disclose:
(a) trade secrets; or
(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.
Commercially valuable information
Paragraphs 5.234 and 5.235 of the FOI Guidelines state:
5.234   To be exempt under s 47(1)(b) a document must satisfy two criteria:
•  the document must contain information that has a commercial value either
to an agency or to another person or body, and
•  the commercial value of the information would be, or could reasonably be
expected to be, destroyed or diminished if it were disclosed
5.235   It is a question of fact whether information has commercial value, and whether
disclosure would destroy or diminish that value. The commercial value may relate, for
example, to the profitability or viability of a continuing business operation or
commercial activity in which an agency or person is involved. The information need not
necessarily have ‘exchange value’, in the sense that it can be sold as a trade secret or
intellectual property. The following factors may assist in deciding in a particular case
whether information has commercial value:
•  whether the information is known only to the agency or person for whom
it has value or, if it is known to others, to what extent that detracts from its
intrinsic commercial value
•  whether the information confers a competitive advantage on the agency or
person to whom it relates — for example, if it lowers the cost of
production or allows access to markets not available to competitors
•  whether a genuine “arm’s-length” buyer would be prepared to pay to
obtain that information
•  whether the information is still current or out of date (out of date
information may no longer have any value), and
•  whether disclosing the information would reduce the value of a business
operation or commercial activity — reflected, perhaps, in a lower share
price
I am satisfied that the relevant information contained in the documents:
•  is only known to the department and the affected third party for whom it has
value

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•  is not known to others, and disclosure of the information would detract from
its intrinsic commercial value
•  confers a competitive advantage on the affected third party, and provides the
affected third party with access to markets not available to its competitors
•  is something that a genuine “arm’s length’ buyer would be prepared to pay to
obtain
•  is still current, and retains its intrinsic value to the affected third party
•  would reduce in value to the business operations or commercial activities of
the affected third party if disclosed.
Based on the above considerations, I am satisfied that documents 4 –  7 contain
information that is commercially valuable to  the affected  third parties. This
information if disclosed could reasonably impact the profitability and commercial
viability of the  third parties. Providing this information would allow an unfair
advantage to the third parties competitors and customers.
As notified to you on 13 June 2024, in accordance with section 27 of the FOI Act, the
department has consulted with affected third parties. In making my decision on access
to the relevant documents, I have taken into consideration the exemption submissions
made during that consultation process.
For the reasons outlined above, I have decided that the parts of the documents marked
‘s47’ are exempt from disclosure under section 47 of the FOI Act.
6.  Section 47F – Documents affecting personal privacy
Section 47F of the FOI Act provides that a document is conditionally exempt if its
disclosure would involve the unreasonable disclosure of personal information about
any person (including a deceased person).
Personal Information
Personal information has the same meaning as in the Privacy Act. Specifically, section
6 of the Privacy Act provides that personal information means information or an opinion
about an identified individual, or an individual who is reasonably identifiable whether
the information or opinion is true or not; and whether the information or opinion is
recorded in a material form or not.
Paragraph 6.123  of the FOI Guidelines states that for particular information to be
personal information, an individual must be identified or reasonably identifiable:
•  whether the information is true or not, and
•  whether the information or opinion is recorded in a material form or not.
Paragraph 6.125 of the FOI Guidelines states that personal information can include a
person’s name, address, telephone number, date of birth, medical records, bank
account details, taxation information and signature.

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Paragraph 6.132 of the FOI Guidelines states that an individual is a natural person and
does not include a corporation, trust, body politic or incorporated association. Section
47F specifically extends to the personal information of deceased persons.
I am satisfied that the  parts of the documents marked ‘s47F’  includes personal
information.
Unreasonable Disclosure of Personal Information
Subsection 47F(2) of the FOI Act provides that in determining whether the disclosure
would involve the unreasonable disclosure of personal information, I must have
regard to the following matters:
(a)  the extent to which the information is well known
(b) whether the person to whom the information relates is known to be (or to have
been) associated with the matters dealt with in the document
(c)  the availability of the information from publicly accessible sources
(d) any other matters that the agency or Minister considers relevant.
Paragraph 6.133 of the FOI Guidelines states that:
The personal privacy exemption is designed to prevent the unreasonable invasion of
third parties’ privacy. The test of ‘unreasonableness’ implies a need to balance the public
interest in disclosure of government-held information and the private interest in  the
privacy of individuals. The test does not, however, amount to the public interest test of
s 11A(5), which follows later in the decision making process. It is possible that the
decision maker may need to consider one or more factors twice, once to determine if a
projected effect is unreasonable and again when assessing the public interest balance.
I note that the AAT, in Re Chandra and Minister for Immigration and Ethnic Affairs [1984]
AATA 437 at paragraph 51-52, stated that:
... whether a disclosure is ‘unreasonable’ requires … a consideration of all the
circumstances, including the nature of the information that would be disclosed, the
circumstances in which the information was obtained, the likelihood of the information
being information that the person concerned would not wish to have disclosed without
consent, and whether the information has any current relevance … it is also necessary in
my view to take into consideration the public interest recognised by the Act in the
disclosure of information … and to weigh that interest in the balance against the public
interest in protecting the personal privacy of a third party ...
Paragraphs 6.137 and 6.138 of the FOI Guidelines state:
6.137
Key factors for determining whether disclosure is unreasonable include:
•  the author of the document is identifiable
•  the documents contain third party personal information
•  release of the documents would cause stress on the third party
•  no public purpose would be achieved through release
6.138
As discussed in the leading s 47F IC review decision of ‘FG’ and National
Archives of Australia [2015] AICmr 26, other factors considered to be relevant include:

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•  the nature, age and current relevance of the information
•  any detriment that disclosure may cause to the person to whom the
information relates
•  any opposition to disclosure expressed or likely to be held by that person
•  the circumstances of an agency’s collection and use of the information
•  the fact that the FOI Act does not control or restrict any subsequent use or
dissemination of information released under the FOI Act
•  any submission an FOI applicant chooses to make in support of their
application as to their reasons for seeking access and their intended or likely
use or dissemination of the information, and
•  whether disclosure of the information might advance the public interest in
government transparency and integrity
You have requested access to documents that contain personal information about a
number of identifiable third parties.
I have reviewed the relevant parts of documents 3 and 4 and I am satisfied that the
disclosure of personal information contained within these documents would, in the
circumstances, constitute an unreasonable disclosure of personal information for the
following reasons:
•  the individuals whose personal information is contained in the documents are
identifiable
•  release of this information could reasonably be expected to cause anxiety to the
individuals concerned
•  no further public purpose would be achieved through the release of the
personal information, noting that the personal information is included in the
document as a result of their employment circumstance
•  the information is current and has not lost its sensitivity through the passage of
time
•  the individuals  would not expect the information to be placed in the public
domain, and detriment may be caused to the individuals  to whom the
information relates, and
•  the FOI Act does not control or restrict any subsequent use or dissemination of
information released under the FOI Act.
In making my decision, I have consulted with the affected third parties regarding the
disclosure of their personal information, and I have considered any concerns raised by
those individuals.
For the reasons outlined above, I have decided that the parts of the documents marked
‘s47F’ are conditionally exempt from disclosure under section 47F of the FOI Act.

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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.
7. Section 47G – Business information
Section 47G of the FOI Act provides that a document is conditionally exempt if its
disclosure would disclose information concerning a person in respect of his or her
business or professional affairs or concerning the business, commercial or financial
affairs of an organisation or undertaking, in a case in which the disclosure of the
information:
(a) 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 organisation or undertaking in respect of its lawful business,
commercial or financial affairs; or
(b) could reasonably be expected to prejudice the future supply of information
to the Commonwealth or an agency for the purpose of the administration of
a law of the Commonwealth or of a Territory or the administration of
matters administered by an agency.
Business information
Paragraph 6.177 of the FOI Guidelines states that the conditionally exempt information
must have some relevance to a person in respect of his or her business or professional
affairs or to the business, commercial or financial affairs of an organisation or
undertaking.
Paragraph 6.191 of the FOI Guidelines states that the use of the term ‘business or
professional affairs’ distinguishes an individual’s personal or private affairs and an
organisation’s internal affairs. The term ‘business affairs’ has been interpreted to mean
‘the totality of the money-making affairs of an organisation or undertaking as distinct
from its private or internal affairs’.
Paragraph 6.193 of the FOI Guidelines states that ‘profession’ is not static, and is clearly
intended to cover the work activities of a person who is admitted to a recognised
profession and who ordinarily offers professional services to the public for a fee.
Documents 1, 3, 4 and 6 contain information that was communicated in confidence
from businesses operating in a professional and/or commercial capacity. I am satisfied
that the disclosure of this information would adversely affect the profitability and
financial viability of third parties. In coming to this conclusion I have considered the
third parties concerns and decided that the release of this information would likely
cause the third parties to suffer both commercial and financial detriment.
In making my decision, I have consulted with the affected third party regarding the
relevant business affairs information, and I have considered any concerns.

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The parts of the documents marked ‘s47G’ contain business affairs information that is
relevant to the business, commercial or financial affairs of an organisation or
undertaking. This information is relevant to the profitability and financial viability of
an organisation or undertaking, and does not relate to its private or internal affairs.
Subsection 47G(2) of the FOI Act provides that subsection 47G(1) does not apply to
trade secrets or other information to which section 47 applies. Section 47G has not been
applied to any information which I have previously decided is exempt under
section 47 of the FOI Act.
For the reasons outlined above, I have decided that the parts of the documents marked
‘s47G’ are conditionally exempt from disclosure under section 47G 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.
8.  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,
on balance, be contrary to the public interest.
Paragraph 6.227 of the FOI Guidelines states that:
‘The pro-disclosure principle declared in the objects of The FOI Act is given specific
effect in the public interest test, as the test is weighted toward disclosure. If a decision
is made that a conditionally exempt document should not be disclosed, the decision
maker must include the public interest factors they took into account in their statement
of reasons…’
I have therefore considered the public interest factors favouring and against  disclosure
of the documents in my assessment.
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.

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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 inform debate on a matter of public importance
•  would promote effective some limited oversight of public expenditure, and
•  would not allow you access to your own personal information.
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:
s47F – personal privacy
•  could reasonably be expected to prejudice the protection of the relevant
individuals’ right to personal privacy,  noting that the substance of the
documents has been released to you and disclosure of the personal information
would not provide you with any further insight into the workings of
government.
•  would not achieve any  public purpose and, on balance, would harm the
individual’s right to personal privacy.
•  would be contrary to the objects of the Privacy Act.
s47G – business affairs
•  could reasonably be expected to expose the business or commercial affairs of an
Australian business to the world at large  and  adversely affect that
organisation’s current or future business and/or commercial opportunities.
Any adverse impact on the contracted parties or supplies used by the
department could reasonably be expected to reduce the pool of information and
service available to the department, which would have adverse impacts on the
ability of the department to source quality and cost-effective goods and
services. Any impediment to the ability of the department to conduct its lawful
affairs with quality and cost-effective business services would be contrary to
the public interest.
•  could reasonably be expected to prejudice the department’s ability to obtain
confidential information from contracted third parties and/or suppliers. Any
impediment to the ability of the department to engage with contracted third
parties and suppliers to progress the department’s operations would be
contrary to the public interest.

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• could reasonably be expected to prejudice an agency’s ability to obtain similar
information in the future. Any impediment to the ability of the department to
engage with contracted third parties and suppliers to obtain information that
helps to inform the department’s policy settings and operational outcomes
would be contrary to the public interest.
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.

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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 and Aged Care
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 review or complaint
You have the right to seek Information Commissioner (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 here: www.health.gov.au/about-us/contact-us/complaints

Document Outline