TRIM Ref: D21-3324925
Mr Michael Betts
By email
: xxxxxxxxxxxxxxxxxxxxxxxxx@xxxxxxxxxxx.xxx.xx
Dear Mr Betts,
FREEDOM OF INFORMATION REQUEST
Request Consultation Process
1. I refer to your query dated 25 October 2021 under the
Freedom of Information Act 1982 (
the FOI
Act) in which you make the following request:
“I seek access to all Government held documents, including but not limited to electronic
messages, recorded voice calls, memos, dossiers, reports, or advice, that contains the
terminology "brain fog", "cognitive", "memory" or "confusion" related to the Comirnaty
Pfizer vaccination. “
2. Following further correspondence from the FOI Team, advising that your request was not
considered to be valid under the FOI Act, on 3 November you replied as follows:
“I disagree with your decision and request an internal review of my request.
The points of relevance relate to my allegation that the Department of Health is being in possession
of documents (inter alia) that contain the terminology "brain fog", "cognitive", "memory" or
"confusion" related to the Comirnaty Pfizer vaccination"
Since this information concerns public health (including mine) I say that I and the Australian
People have a right to access this information.
Document word searches are simple methods to extract these data.
Seeking such documents from Ministerial Offices which encompass my request have not been
actioned and as such, I reserve my right to make complaint with the Office of the Australian
Information Commissioner and/or seek Order of the Federal Circuit Court of Australia.”
Decision Maker
3. I am the Therapeutic Goods Administration (
TGA) officer authorised to make a decision on your
request under the FOI Act.
Request does not meet the formal requirements under the FOI Act
4. As stated in the TGA’s correspondence to you on 2 November 2021, your query is not a valid FOI
request under the FOI Act as it does not meet the formal requirements set out in paragraph
15(2)(b) of the Act.
5. For the purposes of section 24 of the FOI Act, an agency or minister may decide that a practical
refusal reason exists in relation to a request if the request does not satisfy the requirement in
PO Box 100 Woden ACT 2606 ABN 40 939 406 804
Phone: 02 6232 8444 Fax: 02 6232 8605 Email: xxxx@xxx.xxx.xx www.tga.gov.au
paragraph 15(2)(b) (Section 24AA(1)(b)). I am now writing to inform you of my intention to
refuse your request on the basis that a practical refusal reason exists.
6. Under section 24AB of the FOI Act, the TGA is required to allow an applicant a reasonable
opportunity to revise a request before it is refused for a practical refusal reason.
Reasons for decision
7. Paragraph 15(2)(b) of the FOI Act states that in order for a request to be valid, the request must
provide such information as is reasonably necessary to enable a responsible officer of the agency
or the minister to identify the document that is requested.
8. Your request for “
all Government held documents, including but not limited to electronic messages,
recorded voice cal s, memos, dossiers, reports, or advice, that contains the terminology "brain fog",
"cognitive", "memory" or "confusion" related to the Comirnaty Pfizer vaccination”, does not enable
TGA officers to identify specific documents relevant to your request. Therefore, in order to
satisfy your request, TGA officers would be required to retrieve all documents held by the agency
related to the Comirnaty vaccine and undertake searches for the keywords specified in your
request. To do so would amount to a substantial and unreasonable diversion of the TGA’s
resources.
9. For example, the documents initially provided by Pfizer for the provisional registration of the
Pfizer (Comirnaty) vaccine included 158 documents containing at least 34,958 pages. This is
only one component of the documents provided by Pfizer related to the Pfizer (Comirnaty)
vaccine and does not include additional documents such as those for the extension of indication
for use in individuals 12 - 15 years and older. Therefore, all documents held by the TGA would
be significantly larger than this figure and would be too voluminous to process, particularly if
the TGA was required to locate documents relating to Pfizer’s COVID-19 vaccine and to
subsequently search the documents for the keywords you have specified.
Requirement to undertake a request consultation process
10. Under subsection 24(1) of the FOI Act, I, as a decision maker must consult you if I am satisfied
that a “practical refusal reason” exists in relation to your request. A practical refusal reason
exists if the request does not satisfy the requirement in paragraph 15(2)(b) (identification of
documents).
11. In coming to a view that a practical refusal reason exists in relation to your request, I have had
regard to the following:
• your request dated 25 October 2021, and subsequent correspondence on 3 November 2021;
• the relevant sections of the FOI Act, being:
o section 15(2)(b),
o section 24(1), and
o section 24AA(1)(b)
• the volume of documents held by the TGA regarding the Comirnaty vaccine,
• the amount of time it would take TGA officers to extract and search each of the
aforementioned documents for your specified search terms, and
• the volume of relevant information already in the public domain.
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12. A copy of the sections of the FOI Act that set out the consultation process (sections 24, 24AA and
24AB) is at
Attachment A. In deciding whether the processing of your request would involve a
substantial and unreasonable diversion of resources such that a practical refusal reason exists,
I am required under subsection 24AA(2) of the FOI Act to consider the resources that would
have to be used in the following activities:
• identifying, locating and collating the relevant documents;
• deciding whether to grant or refuse access to each document and/or to provide an edited
copy which would include examining each document and consulting with any person
(including those that I would be required to consult under the FOI Act);
• making a copy or edited copy of each document; and
• notifying any interim or final decision on the request (including to any third party consulted
in the event that a decision is made to give access to the documents despite the objections
of the relevant third party).
13. I consider that the number of documents which may potentially fall within the scope of your
request (being all documents held by the TGA relating to the Comirnaty vaccine), in addition to
the necessary consequential work associated with considering whether the documents may be
lawfully disclosed, would have a substantial effect on the operations of the TGA.
14. I also find that the work involved in processing this request would be an unreasonable diversion
of the TGA’s resources, including interrupting TGA officers engaged in evaluation and
assessment of prescription medicines, including vaccines. As to the critical work that these
officers perform, I note that evaluation and assessment of applications for registration for
vaccines and other prescription medicines are required to be finalised within strict statutory
timeframes. TGA’s officers are also engaged in safety monitoring of medicines and vaccines. The
analysis and investigation of medicine and vaccine safety issues, and associated regulatory
actions, are of significant public health impact. As you would appreciate, if these officers are
required to consider large FOI requests, this diverts their time and attention from undertaking
their primary role as evaluators.
15. In addition, the administrative team providing critical support to the TGA’s evaluators and the
other prescription medicine business of the TGA and the FOI team are also currently dealing
with a high volume of COVID-19 related FOI requests. Processing your request would engage
resources of those teams that would otherwise be supporting evaluators, the broader operations
of the TGA’s prescription medicine business and processing other FOI requests. In this regard,
the FOI Guidelines states that a relevant matter in deciding a practical refusal reason exists is
“the impact that processing a request may have on other work in the agency or minister’s office,
including FOI processing (emphasis mine) (see paragraph 3.117 of the FOI Guidelines).
16. I also note that there are likely to be significant charges imposed on you for processing your
request (as calculated in accordance with the
Schedule to the Freedom of Information (Charges)
Regulations 2019) based on the number of documents potentially captured by the scope of your
request.
17. Paragraph 3.117 of the FOI Guidelines indicates another matter I may take into account in
deciding whether a practical refusal reason exists is whether there is a significant public interest
in the documents requested and what information is published. I consider that there is a public
interest in evidence supporting the safety of COVID-19 vaccines that are administered in
Australia. To a very large degree, that information is publicly available and has been provided to
you in previous correspondence.
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18. For example, on 2 November 2021 you were provided links to the range of regulatory documents
relating to the provisional approval of each COVID-19 vaccine. These include the Australian
Public Assessment Report (
AusPAR), the Product Information (
PI) and the Consumer Medicine
Information (
CMI), and they are available at:
www.tga.gov.au/covid-19-vaccines. These
documents provide detailed information regarding the evaluation process for each vaccine and
the data considered in establishing the acceptable safety, quality and efficacy of the vaccine.
19. We also provided you with information regarding adverse event reporting and monitoring and
how to access the Database of Adverse Event Notifications – medicines (
DAEN). To expand on
that process further, I wish to advise that the TGA’s existing safety monitoring system for
vaccines involves:
•
reviewing and analysing reports of suspected side effects (also known as adverse events)
submitted by health professionals and consumers.
• requiring pharmaceutical companies to have
risk management plans for the vaccines they
supply.
• proactively reviewing medical literature and other potential sources of new safety
information.
• working with
international regulators to assess significant side effects detected overseas.
• working with State and Territory health departments and clinical experts to ensure a
coordinated approach.
• Pharmaceutical companies also have legal obligations to monitor, collect, manage and
report on safety data, known collectively as their
'pharmacovigilance responsibilities'.
20. As previously described, all reports submitted to the TGA are evaluated, duplicate reports are
rejected, and the information contained therein is uploaded to the DAEN. The DAEN contains
information on all adverse events reported following administration of a medicine, including the
COVID-19 vaccines.
21. You can search the DAEN for “COVID” in the medicines report section, available here:
https://apps.tga.gov.au/PROD/DAEN/daen-report.aspx. Once you have typed the first three
letters of a medicine name, a list of trade names will appear with the active ingredients shown
in brackets. Where the reporter has only provided the TGA with the active ingredient name, the
database will display 'Tradename not specified'. Select the medicines you want to search for by
ticking or unticking the boxes.
22. You can filter the search results by date. You can also use the ‘Advanced search’ feature to filter
the adverse event results by reaction type, which may assist you in locating information relevant
to your request.
23. There are two types of results shown in two tabs: medicine summary (this summary groups
reported adverse events together) and list of reports (this lists all relevant reports in
chronological order). In the “list of reports” tab when you search for the COVID-19 vaccine, the
results table provides the case number, report entry date, the age of the person, gender,
medicines reported as being taken and the reaction.
24. 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 action. Reporting of an adverse event and publication of an adverse event in the
DAEN does not mean the event was related to the relevant medicine. There might be no
relationship between the adverse event and the medicine - it may be a coincidence that the
adverse event occurred when the medicine was taken, and the symptom may be related to an
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underlying illness or to other factors. If you wish to see further information on the TGA’s guide
to adverse events reporting, you may wish to consider the following:
https://www.tga.gov.au/adverse-event-reporting.
25. The TGA also publishes a weekly safety report for COVID-19 vaccines. All weekly safety reports
remain available on the TGA website at this address
: https://www.tga.gov.au/periodic/covid-
19-vaccine-weekly-safety-report. These weekly reports include information about identified
side effects and safety signals associated with the COVID-19 vaccines.
26. In addition to the vaccine safety monitoring conducted by the TGA, AusVaxSafety, which is led
by the NCIRS and funded by the Australian Government Department of Health, conducts active
vaccine safety surveillance of the COVID-19 vaccines in use in Australia to ensure their ongoing
safety. The information gathered is updated regularly and is accessible here:
https://www.ausvaxsafety.org.au/safety-data/covid-19-vaccines. This includes information
about common and notable side effects of the COVID-19 vaccines and their prevalence.
Notification of request consultation process
27. I am notifying you of my intention to refuse your request on the basis that it does not meet the
formal requirements of section 15(2) of the FOI Act.
28. Before deciding to refuse your request, I am required under paragraph 24(1)(a) of the FOI Act
to undertake a request consultation process in accordance with section 24AB of the FOI Act and
provide you with the opportunity to refine the scope of your request so that the TGA may begin
to process it.
29. Accordingly, you are now afforded fourteen (14) calendar days from your receipt of this letter
in which to contact the TGA to discuss a revision of the scope of your request. Please note that
these are suggestions only and do not guarantee the practical refusal reason will no longer exist.
30. You may wish to consider the following suggestions to revise the scope of your request:
• specifying documents created within a certain date range (for instance, 1 August 2021 – 1
October 2021), or
• specifying kinds of documents (for instance, clinical study reports, adverse event reports),
or
specifying documents created by a particular entity, (for example, the TGA or a third party
company).
31. Before the end of the 14-day consultation period, you must do one of the following:
• withdraw your request;
• make a revised request; or
• indicate that you do not wish to revise your request.
32. Should you choose to revise your request, section 15(5)(b) of the FOI Act provides that the
processing period commences on the day after the day the agency or minister is taken to have
received a request that meets the formal requirements of sections 15(2) and (2A) of the FOI Act.
33. The TGA is then required to take all reasonable steps to notify you of a decision on the request
no later than 30 days after your request becomes valid (s 15(5)(b)).
34. If you have not contacted the TGA within 14 days of receiving this letter to do one of the above
or consulted the TGA to discuss revising its scope, your request is taken to have been withdrawn.
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35. If you wish to refine the scope of your request, you may contact the TGA FOI team on
(02) 6289 4630 or
at xxx.xxx@xxx.xxx.xx.
36. Please note that if you indicate that you do not wish to revise your request or revise your request
in such a way that I am still of the view that processing it would substantially and unreasonably
divert TGA resources from other operations, I may refuse your request under
paragraph 24(1)(b) of the FOI Act.
Yours sincerely,
Authorised and electronically signed by
Dr Grant Pegg
Assistant Secretary
Prescription Medicines Authorisation Branch
Medicines Regulation Division
Therapeutic Goods Administration
Department of Health
16 November 2021
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Document Outline
