Delegate of the Australian Information Commissioner for the purposes of s 55K of the Freedom of Information Act 1982**

Freedom of Information - Whether a practical refusal reason exists - Whether work involved in processing the request would substantially and unreasonably interfere with the performance of the Agency's functions - (CTH) Freedom of Information Act 1982 ss 24, 24AA, and 24AB

1. Under s 55K of the Freedom of Information Act 1982 (the FOI Act), I vary the deemed decision of the Department of Health and Aged Care (the Department) of 30 October 2021. I substitute my decision that a practical refusal reasons exists for the purposes of

1. This decision primarily discusses whether a practical refusal reason exists in relation to a deemed decision. It provides an example of a circumstance in which processing a broadly worded request for information or documents could lead to a substantial and unreasonable diversion of an agency's resources in circumstances where the agency has made targeted suggestions about scope to the applicant (which they did not accept).

1. On 30 September 2021, the applicant made the following request to the Therapeutic Goods Administration (TGA):

[Part 1 of request] Substantiated scientific evidence and data that proves through short term and long-term studies that the covid vaccines available in Australia are safe, effective, and necessary. [Part 2 of request] Can you please provide substantiated scientific evidence and peer reviewed studies that proves making a vaccine mandatory for teachers/educators decreases the risk of infection and transmission to staff and students/children in the workplace.

1. The TGA, which is part of the Department, is responsible for evaluating, assessing and monitoring products that are defined as therapeutic goods. According to its website, its role is to regulate medicines, medical devices and biologicals to help Australians stay healthy and safe.[1]
2. Initially the Department considered the applicant's request was invalid on the basis that it did not meet the requirements of s 15(2)(b) of the FOI Act. However, the Department now maintains that a practical refusal reason applies.[2]
3. The issue to be decided in this Information Commissioner review (IC review) is whether the work involved in processing the applicant's request would substantially and unreasonably divert the resources of the Department from its other operations.
4. In an IC review of an access refusal decision, the agency bears the onus of establishing that its decision is justified, or that I should give a decision adverse to the applicant.[3]
5. In making my decision, I have had regard to the following:
   • Correspondence between the Department and applicant at the time of the FOI request
   • the FOI Act[4]
   • the Guidelines issued by the Australian Information Commissioner under s 93A of the FOI Act[5] to which agencies must have regard in performing a function or exercising a power under the FOI Act,[6] and
   • the parties' submissions.

Whether the Department was entitled to refuse access for a practical refusal reason (s 24)

1. Section 24 of the FOI Act sets out the requirements an agency or Minister must satisfy to refuse access to documents because of a practical refusal reason. In deciding on this issue, I am required to consider:
   • whether a request consultation process has been undertaken in accordance with s 24AB of the FOI Act, and if so
   • whether I am satisfied that the work involved in processing the applicant's request would 'substantially' divert the resources of the agency from its other operations, and
   • whether I am also satisfied that the work involved in processing the applicant's request would 'unreasonably' divert the resources of the agency from its other operations.[7]

Whether a request consultation process was undertaken (s 24AB)

1. For a request consultation process to have been undertaken for the purposes of s 24(1)(a) of the FOI Act, the applicant must have been notified in accordance with s 24AB(2) of the FOI Act. If the applicant contacts the relevant contact person, then the agency must 'take reasonable steps to assist the applicant to revise the request so that the practical refusal reason no longer exists' (s 24AB(3)). What constitutes 'reasonable steps' is informed by s 24AB(4)[8] and the FOI Guidelines,[9] but it must be considered on a case-by-case basis.[10]
2. The Department did not engage in a request consultation process with the applicant prior to its deemed access refusal decision. Therefore, it did not meet the requirements of s 24AB at the relevant time.
3. However, as noted in previous decisions[11], it is open to me to consider that the steps taken by an agency to consult with the applicant during an IC review cure their failure to take reasonable steps during the request consultation period. In this case, I consider the Department has taken reasonable steps to assist the applicant to revise the request so that the practical refusal reason no longer exists.
4. During the IC review, the OAIC assisted the parties to conduct consultations about the scope of the request, including providing targeted suggestions to the applicant. The Department proposed scopes it could process to the applicant on 2 occasions:

• on 24 February 2025, the Department proposed the following revised request

A copy of the Delegate's overview for [insert vaccine supplied in Australia from the above list].[12]

a. The delegate's overview for the provisional registration of the Comirnaty vaccine (This was previously released under FOI 2389 and available under our FOI Disclosure Log); > > b. The Australian Public Assessment Reports (AusPAR) for both the provisional and full registration of the Comirnaty vaccine; > > c. Australian Product Information of Pfizer's Comirnaty vaccine; and > > d. the COVID-19 Vaccine Safety Report.[13]

1. The applicant responded to the suggested revisions, but did not agree to revise their request as suggested.[14]
2. Though I acknowledge the applicant considered the proposed scopes did not sufficiently consider the short-term and long-term side effects, having regard to the scope of the request, and contextual information provided by the Department, I consider the proposed scopes are reasonable and demonstrate genuine attempts by the Department to assist the applicant to revise the request to remove the practical refusal reason. In these circumstances I consider the Department has taken reasonable steps to consult with the applicant and has met the requirements of

Whether a practical refusal reason exists (s 24AA(1)(a)(i))

1. In determining whether a practical refusal reason exists for the purposes of

s 24AA(1)(a)(i) of the FOI Act I must first consider whether I am satisfied that the diversion of the Department's resources from its other operations would be substantial. If I am satisfied that it would be, I must then consider if that substantial diversion would be 'unreasonable'.[15] 2. In answering this question, I have had regard to the relevant mandatory factors listed in s 24AA(2) of the FOI Act but I have not considered the factors set out in s 24AA(3) of the FOI Act.[16]

Whether the work involved in processing the request would substantially divert the resources of the Department from its other operations

1. The Department submitted that 2000 documents (consisting of 100,000 pages) are in scope of the request, and that processing it would take 6027 hours.[17]
2. The Department provided the following estimates for the processing of the applicant's request:

1. Based on the available information, I consider that the Department's estimate of the time for processing the request is reasonable. The Department provided details and evidence of its searches for documents within scope of the request and undertook sampling of a portion of the documents.
2. In my view, the Department also provided a reasonable explanation for why there are such a large number of documents responsive to the request. In particular the Department advised:
   • there are many vaccines and often there are a number of applications for each vaccine for different indications
   • in any single application, there are a large number of documents and extensive data that relates to the issue of safety and efficacy
   • data submitted is complex and voluminous and there is a lot of data the sponsor has to submit to establish the safety, quality and efficacy of a vaccine and its benefit/risk ratio
   • it is not the case that there is a single document that can demonstrate this
   • relevant documents would likely capture the Delegate's overview, clinical data, non-clinical toxicological data, clinical evaluation report, non-clinical evaluation report, the product information and consumer medicine information file, the risk management plan, committee papers and minutes, and approval letters.
3. Based on the information provided by the Department, including its searches and the above explanation, I accept that a significant volume of documents fall within scope of the request. I consider the Department's estimates to be reasonable, and that processing the applicant's request would involve a substantial diversion of the Department's resources.

Whether the work involved in processing the request would unreasonably divert the resources of the Department from its other operations

1. The Department maintains that processing the request would unreasonably divert its resources from its other operations for the following reasons:
   • Processing a request of this size would divert TGA officers from their core regulatory functions and duties.
   • A large number of documents will require specialist knowledge of the process of provisional registration of vaccines, the post-market assessments of vaccines, how regulatory bodies (local and overseas) collaborate, specialist knowledge on what information would require 3rd party consultation based on commercial sensitivities.
   • The processing of this request will severely prejudice the regulatory functions of the TGA. The consequence being that other FOI requests are not processed, and the ordinary regulatory functions of the TGA are severely impacted.
   • The Department also explained that a large amount of information about the safety and efficacy of vaccines has already been released. The Department advised it provided the applicant with links to articles summarising the safety and efficacy studies on the three vaccines approved for supply in Australia at the time (being the Pfizer, Astra Zeneca and Moderna vaccines) and part of Australia's COVID-19 vaccination program.
2. The applicant has not specifically addressed this issue. That said, it is apparent from their correspondence with the OAIC that they consider there is a significant public interest in understanding the safety of the vaccines and their short-term and long-term effects, particularly given the government restrictions imposed at the time.
3. The question of whether processing the request would involve an unreasonable diversion of the Department's resources requires a consideration of whether the work involved is unreasonable, such that it might undermine the discharge of the Department's normal functions.[19]
4. Having regard to the request, the details of searches, and the contextual information provided by the Department above at [20], I accept that the applicant's request is extremely broad, as evidenced by the volume of documents that the Department identified as being responsive to the request. As noted above at [x], there were attempts by the Department to assist the applicant to frame the request to remove the practical refusal reason which the applicant did not agree to. Further, I also accept that although there is a significant public interest in the documents sought, some of this public interest is likely to have been diminished due to the passage of time and following the publication of documents pertaining to the same or similar subject matter by the Department. As noted above at [22], the Department advised it has provided the applicant with links to these documents.
5. Although the Department has substantial resources and a dedicated FOI team to undertake FOI processing, I accept that processing a request of this size and volume would unreasonably divert the resources of the Department from its other operations, which, as noted above, include regulating medicines, medical devices and biologicals to help Australians stay healthy and safe.

1. For the reasons set out above, I find that the Department has established that a practical refusal reason exists for the purposes of s 24(1)(b) of the FOI Act in relation to Part 1 of the request. Accordingly, the Department was authorised under s 24(1)(b) of the FOI Act to refuse access to the documents in accordance with the request.

General Manager Freedom of Information Case Management

Delegate of the Australian Information Commissioner for the purposes of s 55K of the Freedom of Information Act 1982

Relevant provisions of the FOI Act, FOI Guidelines, and decisions

Whether a request consultation process was undertaken (s 24AB)

(1) This section sets out what is a request consultation process for the purposes of section 24.

(2) The agency or Minister must give the applicant a written notice stating the following:

(a) an intention to refuse access to a document in accordance with a request;

(c) the name of an officer of the agency or member of staff of the Minister (the contact person) with whom the applicant may consult during a period;

(d) details of how the applicant may contact the contact person;

(e) that the period (the consultation period) during which the applicant may consult with the contact person is 14 days after the day the applicant is given the notice.

(3) If the applicant contacts the contact person during the consultation period in accordance with the notice, the agency or Minister must take reasonable steps to assist the applicant to revise the request so that the practical refusal reason no longer exists.

(4) For the purposes of subsection (3), reasonable steps includes the following:

(a) giving the applicant a reasonable opportunity to consult with the contact person;

(b) providing the applicant with any information that would assist the applicant to revise the request.

(5) The contact person may, with the applicant's agreement, extend the consultation period by written notice to the applicant.

(6) The applicant must, before the end of the consultation period, do one of the following, by written notice to the agency or Minister:

(c) indicate that the applicant does not wish to revise the request.

(7) The request is taken to have been withdrawn under subsection (6) at the end of the consultation period if:

(a) the applicant does not consult the contact person during the consultation period in accordance with the notice; or

(b) the applicant does not do one of the things mentioned in subsection (6) before the end of the consultation period. [emphasis in original]

Where an agency or minister is satisfied that a practical refusal reason exists, they must undertake a request consultation process with the applicant before making a decision to refuse the request (s 24AB).

The agency or minister must give the applicant a written notice that states:

• an intention to refuse access to a document in accordance with a request
• the practical refusal reason
• the name and contact details of an officer with whom the applicant may consult during the process, and details of how the applicant may contact them
• that the consultation period during which the applicant may consult the contact person is 14 days after the day the applicant is given the notice (s 24AB(2)).

Agencies and ministers are only obliged to undertake a request consultation process once for any particular request (s 24AB(9)), but they may choose to continue discussions with an applicant in order to refine a request that is still too large or vague.

If an applicant contacts a contact officer during the consultation period, the contact officer must take reasonable steps to help them revise the request so that the practical refusal reason no longer exists (s 24AB(3)). For example, a contact officer could provide a breakdown of the time estimated for each step of the process, explain the difficulties the agency will have in dealing with the request and suggest what would be a reasonable request in the circumstances.[20]

Whether a practical refusal reason exists (ss 24 and 24AA)

Section 24 of the FOI Act enables an agency or Minister to refuse access to a document where the agency has undertaken a request consultation process in accordance with s 24AB of the FOI Act, and after that process the agency or Minister is satisfied that the practical refusal reason still exists.

Subparagraph 24AA(1)(a) of the FOI Act lists the following practical refusal reason:

(1) For the purposes of section 24, a practical refusal reason exists in relation to a request for a document if either (or both) of the following applies:

(i) in the case of an agency--would substantially and unreasonably divert the resources of the agency from its other operations; or

(ii) in the case of a Minister--would substantially and unreasonably interfere with the performance of the Minister's functions;

Subsection 24AA(2) of the FOI Act lists matters which a decision maker must consider where relevant in deciding whether or not a practical refusal reason exists. It is a non-exhaustive list.

(3) In deciding whether a practical refusal reason exists, an agency or Minister must not have regard to:

(a) any reasons that the applicant gives for requesting access; or

(b) the agency's or Minister's belief as to what the applicant's reasons are for requesting access; or

(c) any maximum amount, specified in the regulations, payable as a charge for processing a request of that kind.

As set out in 'ACW' and Australian National Maritime Museum [2023] AICmr 4 ('ACW'), a decision maker must consider the following 3 elements in determining the issue of whether a practical refusal reason exists for the purposes of s 24AA(1)(a)(i) of the FOI Act:

• First, I must determine whether a request consultation process has been undertaken in accordance with s 24AB of the FOI Act. In many cases, this element of the decision-making task may be dealt with briefly because it is clear that a relevant process has been validly conducted and no agreement as to validity arises between the parties to the IC review.
• Secondly, if I determine that a request consultation process has been validly undertaken, I must determine whether I am 'satisfied' that the work involved in processing the applicant's request (as revised, if at all, during the request consultation process) would 'substantially' divert the resources of the agency from its other operations.
• Thirdly, if I am satisfied of a substantial diversion of resources, I must determine whether I am also 'satisfied' that the work involved in processing the applicant's request would 'unreasonably' divert the resources of the agency from its other operations.[21]

To be 'satisfied' for the purposes of s 24(1) of the FOI Act that a practical refusal reason exists, a decision maker must 'feel' an 'actual persuasion' that the reason exists. They cannot be satisfied simply as a result of a 'mere mechanical comparison of probabilities independently of any belief in its reality'.[22] Moreover, a decision maker's 'satisfaction' as to the existence of a practical refusal reason cannot be arbitrary or capricious; it must be formed 'according to law and not humour'.[23]

A diversion of an agency's resources will be considered to be 'substantial' if the diversion can be characterised as 'real or of substance' rather than 'large'.[24]

The FOI Guidelines explain:

In deciding if a practical refusal reason exists, an agency or minister must have regard to the resources required to perform the following activities specified in s 24AA(2):

• identifying, locating or collating documents within the filing system of the agency or minister
• examining the documents
• deciding whether to grant, refuse or defer access
• consulting with other parties
• redacting exempt material from the documents
• making copies of documents
• notifying an interim or final decision to the applicant.

Other matters that may be relevant in deciding if a practical refusal reason exists include:

• the staffing resources available to an agency or minister for FOI processing
• whether the processing work requires the specialist attention of a minister or senior officer, or can only be undertaken by one or more specialist officers in an agency who have competing responsibilities
• the impact that processing a request may have on other work in an agency or minister's office, including FOI processing
• whether an applicant has cooperated in framing a request to reduce the processing workload
• whether there is a significant public interest in the documents requested
• other steps taken by an agency or minister to publish information of the kind requested by an applicant
• as to a request to a minister - other responsibilities of the minister and demands on the minister's time, and whether it is open to the minister to obtain assistance from an agency in processing the request.[25]

If a party to an IC review is unsatisfied with an IC review decision, they may apply under s 57A of the FOI Act to have the decision reviewed by the Administrative Review Tribunal (ART). The ART provides independent merits review of administrative decisions and has power to set aside, vary, or affirm an IC review decision.

An application to the ART must be made within 28 days of the day on which the applicant is given the IC review decision (see s 18(1) of the Administrative Review Tribunal Act 2024 and rule 5(3) of the Administrative Review Tribunal Rules 2024). An application fee may be payable when lodging an application for review to the ART. Further information is available on the ART's website (www.art.gov.au) or by telephoning 1800 228 333.

Making a complaint to the Commonwealth Ombudsman

If you believe you have been treated unfairly by the OAIC, you can make a complaint to the Commonwealth Ombudsman (the Ombudsman). The Ombudsman's services are free. The Ombudsman can investigate complaints about the administrative actions of Australian Government agencies to see if you have been treated unfairly.

If the Ombudsman finds your complaint is justified, the Ombudsman can recommend that the OAIC reconsider or change its action or decision or take any other action that the Ombudsman considers is appropriate. You can contact the Ombudsman's office for more information on 1300 362 072 or visit the Commonwealth Ombudsman's website at http://www.ombudsman.gov.au.

If you would like access to the information that we hold about you, please contact FOIDR@oaic.gov.au. More information is available on the Access our information page on our website.

[1] Therapeutic Goods Administration (TGA) | Australian Government Department of Health.

[2] The Department advised that it does not hold any documents responsive to Part 2 of the request and that the practical refusal arises due to the number of documents within scope of Part 1 of the request. However, since a practical refusal reason will apply to the entirety of a request, it is unnecessary for me to consider s 24A.

[4] Sections 24, 24AA, and 24AB as set out in Annexure A.

[5] See, Office of the Australian Information Commissioner_, Guidelines issued by the Australian Information Commissioner under_ s 93A of the Freedom of Information Act 1982 (FOI Guidelines).

[7] See 'ACW' and Australian National Maritime Museum (Freedom of information) [2023] AICmr 4 at [10] as set out in Annexure A.

[10] Justin Warren and Department of Human Services (Freedom of information) [2019] AICmr 22 at [32].

[11] See, for example, 'AIG' and Australian Federal Police (Freedom of information) [2024] AICmr 52 at [34], and 'AVC' and Civil Aviation Safety Authority (Freedom of information) [2025] AICmr 67 (15 April 2025).

[12] The Department advised the delegate's overview is a substantial document that includes a summary of safety and efficacy data relating to the vaccine, including clinical (human) and non-clinical (animal) studies.

[13] The Department also advised, 'Broadly, a summary of the documents in the proposed expanded scope is as follows: (a) a summary of matters relevant to the provisional registration decision, including safety and efficacy data at the time of approval (b) summary of the TGA's evaluation and decision making process for provisional and full registration (c) the product information provides health professionals with a summary of the scientific information relevant to the safe and effective use of a prescription medicine and (d) contains a summary of reported adverse events (reported side effects).'

[14] In their response the applicant advised the registration details of the vaccines were not part of their request and the scope does not sufficiently address the short-term or long-term side effects.

[15] See 'ACW' and Australian National Maritime Museum (Freedom of information) [2023] AICmr 4 at [10] as set out in Annexure A.

[17] The Department also noted that for the initial registration of Pfizer, being just one vaccine supplied in Australia, there were 784 documents and 42,041 pages as at February 2021 of which at least 35,000 pages appear to be within scope (being clinical and non clinical data).