TRIM Ref: D22-5034675
FREEDOM OF INFORMATION REQUEST FOI 3407
Notice of Decision – Request for a waiver of charges
1. I refer to your request dated 8 November 2021 under the Freedom of Information Act
(the FOI Act) for access to the following documents:
“Please provide a document recording the number of serious adverse events
reported fol owing covid-19 vaccine injection in Australia to date
(7/11/2021). As vaccine pharmacovigilance goes, an adverse event following
immunisation is considered serious if it results in:
+ is life-threatening
+ requires inpatient hospitalisation
+ prolongation of existing hospitalisation persistent or significant
+ disability/incapacity congenital anommoly/birth defect”
2. On 8 November 2021, the TGA received a request from you under the FOI Act.
3. On 6 December 2021, the TGA advised you of the overall number of adverse event
reports related to COVID-19 vaccines. As you were provided the information
requested in the scope of your FOI request, the TGA invited you to confirm whether
this information satisfied your request, and, accordingly, whether you agreed to
withdraw your request. I note that you did not respond to this correspondence.
4. As no response was received from you, the FOI team continued processing your
request. Accordingly, on 8 December 2021, you were advised that the costs associated
with processing your request amounted to $65.22, and you were asked to:
• pay the charge, being the deposit outlined above, and notify the FOI Team; or
• notify the TGA that you wish to contend that:
• the charge had been wrongly assessed, giving reasons; or
• the charge should be reduced or not imposed (for instance, where
payment of the charge would cause you financial hardship or where
you believe access to documents is in the general public interest), with
notify the TGA that y ou withdraw your request.
PO Box 100 Woden ACT 2606 ABN 40 939 406 804
Phone: 1800 020 653 or 02 6232 8644 Fax: 02 6232 8112
5. On 17 December 2021, the TGA received a request from you for a waiver of charges on
public interest grounds, as follows:
“The Australian public have a right to know the number of serious adverse events
reported fol owing covid-19 vaccine injection.
Under section 8 of the Charges Regulations an agency has discretion to not impose
a charge. I contend that the charge should not be imposed in accordance with
Section 29(1)(c) of the FOI Act. Please take into account that giving access to the
documents in question is in the general public interest and in the interest of a
substantial section of the public.
The agency (TGA) and the Department of Health have not been providing this
information to the Australian public. The agency has also disabled the export
function on their Database of Adverse Event Notifications making it impossible for
the Australian public to export the data for assessment and analysis. Until the
agency begins to regularly disclose the number of serious adverse events fol owing
covid-19 vaccine injections the Australian public wil have to continue to rely
requests made under the FOI Act for such information.”
It is unreasonable and at odds with the FOI Act's objects to expect the Australian
public to pay money to receive this very critical information.
6. I am the TGA officer authorised to make this decision under section 23 of the FOI Act.
What follows is my decision under the FOI Act.
7. I have decided not to waive the charges that can be imposed for the processing of your
Material Considered in Decision-Making
8. In coming to my decision, I had regard to the fol owing:
• your request for documents under the FOI Act dated 8 November 2021;
• my initial decision of 8 December 2021 to impose charges of $65.22;
• the correspondence from you dated 17 December 2021, requesting that the
charges be waived as access to the documents is in the public interest;
• the FOI Act and, in particular, section 29 of the FOI Act; and
• the guidelines issued by the Australian Information Commissioner under
section 93A of the FOI Act (FOI Guidelines).
Reasons for Decision
9. In considering a request that charges not be imposed, subsection 29(5) of the FOI Act
Without limiting the matters the agency or Minister may take into account in
determining whether or not to reduce or not to impose the charge, the agency or
Minister must take into account:
(a) whether the payment of the charge, or part of it, would cause financial
hardship to the applicant, or to a person on whose behalf the application
was made; and
(b) whether the giving of access to the document in question is in the general
public interest or in the interest of a substantial section of the public.
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10. In addition, Part 4 of the FOI Guidelines sets out the matters I must have regard to in
considering a request not to impose a charge.
11. In making this request for a waiver of charges, you have not made submissions
relating to your current financial affairs or provided any evidence of financial
hardship, and, furthermore, you have not requested a waiver or reduction of charges
on financial hardship grounds.
12. Therefore, currently, there is insufficient evidence for me to be satisfied that payment
of the charge would cause you financial hardship.
In considering whether granting access to the documents would be in the public
interest or in the interest of a substantial section of the public, the FOI Guidelines note
that it is important to identify the ‘general public interest’ or the ‘substantial section of
the public’ that would benefit from disclosure.
14. In considering the public interest, paragraph 4.109 of the FOI Guidelines sets out a
non-exhaustive list of examples in which it may be appropriate to reduce or waive a
charge. The factors that may be relevant to your request include the following:
• the documents relate to a matter of public debate, or to a policy issue under
discussion within an agency, and disclosure will assist public comment on, or
participation in, the debate or discussion; and
• the documents relate to an agency decision that has been a topic of public
interest or discussion, and disclosure of the documents would better inform
the public as to why or how the decision was made, including highlighting any
problems or flaws that occurred in the decision-making process.
15. In your submission you indicated that there is public interest in the disclosure of the
documents for the following reason:
“The Australian public have a right to know the number of serious adverse events
reported fol owing covid-19 vaccine injection.”
16. I note that the TGA FOI Team advised you on 6 December 2021 of the overall number
of adverse event reports related to COVID-19 vaccines which were either categorised
as a serious adverse event or which reported that the person experiencing the adverse
event was hospitalised.
17. I do agree that, in light of the current pandemic, there is public interest in adverse
event information related to vaccinations for COVID-19. However, in my view, the
public interest has been met, to a very large degree, by the information that is already
publicly available on the TGA website, including the Database of Adverse Event
. The DAEN contains information from all reports of adverse events
that the TGA has received in relation to medicines, including vaccines, used in
18. Reporting of an adverse event and publication of an adverse event in the DAEN does
not mean the event was related to the vaccine. Expert analysis and review of adverse
event reports is needed to determine whether there may be a link between reported
events and vaccination.
19. All adverse event reports are used by the TGA equal y in our monitoring of product
safety. As such, it is my view that the total number of adverse event reports classified
as ‘serious’ does not provide significant information in terms of assessing vaccine
safety beyond that which is already publicly available. The TGA analyses adverse
event report data and reviews individual reports to identify possible safety issues for
investigation. If these investigations confirm a safety signal, the TGA takes appropriate
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action. This includes taking prompt action to make this information available to health
professionals and the public.
20. Further information about the safety of medicines and how the TGA monitors safety is
available here: https://www.tga.gov.au/medicines-safety.
21. Furthermore, the TGA publishes a COVID-19 weekly safety report which contains
information about adverse events fol owing immunisation. This can be accessed at
22. In your submission, you also noted that:
“The agency has also disabled the export function on their Database of Adverse
Event Notifications making it impossible for the Australian public to export the
data for assessment and analysis.”
23. I wish to inform you that the information currently contained on the DAEN can be
extracted by copying and pasting the List of Reports table into your desired form. You
can do this by setting the number of ‘Records to display’ to the highest value, ‘500’, and
then copying the List of Reports table and pasting into an Excel spreadsheet.
24. On that basis, I am satisfied that insofar as there is a general public interest in
“available and transparent
” information about adverse event reports received for
COVID-19 vaccines, this interest is satisfied by resources in the public domain which
are regularly updated by the TGA including the DAEN and the weekly safety report.
25. Therefore, given the publicly available information already published in relation to the
COVID-19 vaccinations, I am not satisfied that a substantial section of the public may
benefit from the disclosure of this information.
26. For the reasons outlined above, I have decided not to waive the charges that apply to
the processing of your request.
27. In my view, this approach balances the potential public interest in this matter with the
intent of the FOI Act that charges can be imposed for processing FOI requests.
28. Please note my decision not to waive the charges will apply to the final amount
charges that can be imposed. Under the Freedom of Information (Charges) Regulations
(the Charges Regulations), once an FOI request is complete, the TGA is required
to determine the actual
charges that can be imposed under the Charges Regulations
associated with processing the request. This final amount may be higher or lower than
the estimated charges.
29. In the event the final charge is less than the estimate, you will be refunded the
difference. If the final charges exceed the estimate (and my decision is to give you full
access to all relevant information) regulation 10(2) allows me to charge the actual
cost. If any information is exempt, a higher amount cannot be imposed.
Time limit for processing your FOI request
30. The time limit for processing your request is suspended, in accordance with section 31
of the FOI Act, from the date you receive this notice and resumes on the day you pay
the charge or deposit of $20.00.
31. Under subsection 29(1) of the FOI Act, you have 30 calendar days from receipt of this
• pay the charge, being the deposit or full amount outlined above, and notify the
FOI Team via the email below; or
• seek an internal review of this decision; or
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• notify the TGA that you withdraw your request.
32. If you fail to notify the TGA within 30 days about what you propose to do, the FOI Act
provides under subsection 29(2) that you are taken to have withdrawn your request.
Review and Complaint Rights
33. If you are not satisfied with this decision, you can either seek internal review or apply
to the OAIC for review of the decision. Further information can be found on the OAIC
website at the following link: www.oaic.gov.au/freedom-of-information/reviews-and-
34. If you have any queries regarding this matter, please contact the FOI Team on
(02) 6289 4630.
Dr Claire Larter
Therapeutic Goods Administration
13 January 2022
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