TRIM Ref:
D22-5161101
Mr Jimmy Recard
By Email: xxxxxxxxxxxxxxxxxxxxxxxxx@xxxxxxxxxxx.xxx.xx
Dear Mr Recard,
FREEDOM OF INFORMATION REQUEST FOI 3603
Request Consultation Process
1. I refer to your request dated 31 January 2022 under the
Freedom of Information Act 1982 (
the
FOI Act) in which you sought access to the following documents:
“1. In regards to correspondence between the Department of Health and
a) "international regulators" and/or
b) "territory health departments and/or
c) "pharmaceutical companies" and/or
d) " State and Territory health departments and clinical experts"
that contain both the term "brain fog" and the word "Comirnaty"
2. In regards to the medical literature and other potential sources of new safety information
in relation to the side effect of "brain fog" and "Comirnaty".
3. that is known as the "risk management plan" of Comirnaty Covid-19 vaccination.
4. Any internal memo's between the TGA and the Australian Federal Minister of Health that
include the term "Brain Fog" and "Comirnaty."
Decision Maker
2. I am the Therapeutic Goods Administration (
TGA) officer authorised to make a decision on
your request under the FOI Act.
Request too voluminous to process
3. The TGA has now undertaken a preliminary search and retrieval for documents falling within
the scope of your request. As a result, I can confirm that the scope of your request is too
voluminous to process.
4. Regarding item 1 of your request, preliminary estimates from the relevant line areas of the
TGA suggest that the scope of your request includes approximately 312 documents, containing
a total of approximately 15,072 pages. Each of these documents contains sensitive health
information and will require consultation with third parties, including States and Territories,
and the subjects of adverse event reports. As a result, your request is too voluminous to
process.
5. I wish to advise you that the TGA does not hold any documents falling within the scope of
item 2 or item 4 of your request.
6. Regarding item 3 of your request, I wish to advise you that the TGA holds multiple versions of
the Pfizer Comirnaty EU Risk Management Plan (
RMP) and multiple versions of the Risk
Management Plan Australia-Specific Annex (
ASA). Preliminary estimates suggest that the
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
scope of item 3 of your request includes 8 documents, containing approximately 1,160 pages.
Each of these documents contains commercially valuable information. These documents will
require consultation with third parties, including the pharmaceutical sponsor. As a result, your
request is too voluminous to process.
7. However, I am pleased to advise you that the EU RMP has been published online by the
European Medical Agency. The TGA has also published the ASA in response to a previous FOI
request. As such, the documents you are seeking in item 3 are publicly available. Further
information and guidance on accessing these documents is provided below.
8. Given the scope of documents falling under your request, I am of the view that your request is
too voluminous to process.
Requirement to undertake a request consultation process
9. Under paragraph 24(1)(a) 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 work involved in processing the request would substantially and
unreasonably divert the resources of the TGA from its other operations. As mentioned above, I
am of the view that a practical refusal reason exists in relation to your request.
10. 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 section 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 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).
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 31 January 2022.
• the estimated volume of documents involved, and the work involved in processing them,
for example, approximately 320 documents containing approximately 16,232 pages.
• Each of the documents relevant to Item 3 of your request may contain commercially
valuable information, that is likely to have a commercial value to the sponsor that would
be, or could reasonably be expected to be, destroyed or diminished if the information
were disclosed. Consideration would need to be given to whether an exemption should
be claimed and whether consultation with the relevant third party is required, and, if so,
preparation of schedules for the third party detailing all relevant documents.
• in addition, each document relevant to Item 1 of your request is likely to contain
personal information, in relation to which consideration would need to be given to
whether an exemption should be claimed and whether consultation with the relevant
third party is required and, if so, preparation of schedules for the third party detailing all
relevant documents.
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• this is particularly relevant as the data includes sensitive health information, which may
also include coroner’s reports that are likely to require consultation with the third
parties or the representatives of deceased persons.
• even if personal information were redacted, the individuals concerned may still be
reasonably identifiable to their family members, or members of the public, due to the
sensitive health information contained in the reports.
• further, as some of these reports may have been reported in the media and on the TGA’s
website, even with personal information redacted, these persons may still be reasonably
identifiable from the remaining information in the reports. Due to my concern that these
individuals may stil be reasonably identifiable in the documents, even with personal
information redacted, the TGA would need to consult with a significant number of third
parties.
• the number of affected third parties. The FOI Guidelines provides that there is a
requirement to consult with an individual or legal personal representative of a deceased
person under section 27 of the FOI Act (see paragraphs 1.27 and 6.161).
• to release this information would likely require the TGA to consult with at least 2 – 3
third parties per document for item 1 of your request, and as such, there is likely to be in
excess of 624– 936 third parties.
• the TGA would also be required to consult with additional third parties in relation to
documents relevant to item 3 of your request, including the vaccine sponsor. The
number of third parties required to be consulted would make this request too onerous to
process.
• as you would appreciate, the TGA would need to write to each third party individually,
attach copies of their documents, and consider the responses provided and any
requested redactions. I would then need to make a decision on these documents,
considering these submissions. In addition, if any of the third parties objected to release
of documents and I disagreed with them, then I would need to provide them with a
decision.
• that advice on the data and sensitivity of the information in these documents would need
to be provided by specialised technical staff at the TGA (i.e., senior medical officers,
nurses, pharmacists and scientists) a majority of whom are presently engaged in analysis
of adverse event data and investigation of safety issues relating to COVID-19 vaccines.
• the assumption that a substantial number of those documents may be capable of being
made available (even if in edited form with exempt material redacted), the time taken to
appropriately edit each document and to make copies.
• the fact that any decision letter would need to list each document in an attachment
setting out the outcome of the consideration of whether exemptions apply.
12. I consider that the number of pages estimated to fal within the scope of your request and the
fact that much of the information is sensitive health information or commercially valuable
information, 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.
13. I also find that the work involved in processing this request would be an unreasonable
diversion of the TGA’s resources. If these officers are required to consider large FOI requests,
this diverts their time and attention from undertaking their primary role. In addition, the
administrative team providing critical support to the TGA’s evaluators and the other safety
monitoring 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
medicines safety monitoring 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
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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).
14. 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 third parties.
Guidance on accessing the TGA’s publicly available information
15. I note that 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 and efficacy of COVID-19 vaccines
that will be used in Australia.
16. To a very large degree, the public interest is met through the publication of regulatory
documents along with information on adverse event reports that is publicly available in the
Database of Adverse Event Notifications (
DAEN) and the TGA’s weekly safety reports.
17. As noted above, in relation to Item 3, the European Medicines Agency has made the Comirnaty
EU RMP available online. You can access these documents at:
https://www.ema.europa.eu/en/medicines/human/EPAR/comirnaty and the links therein.
18. In addition, the TGA has published the Comirnaty ASA under a previous FOI request. This
document is considered in conjunction with the EU RMP. This document is available at:
https://www.tga.gov.au/foi-disclosure-log (see FOI 2389, Document 7). Please note, some
commercially confidential information has been redacted from this document.
19. The TGA has published a 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.
20. You may be particularly interested in the AusPAR for each approval of the Comirnaty vaccine,
which contains a summary of the TGA evaluation of the sponsor’s RMP.
21. The TGA continuously monitors the safety of all medicines in use in Australia. If our monitoring
confirms a safety issue, we take prompt action to make this information available to health
professionals and the public.
22. 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, consumers, state and territory health departments and
pharmaceutical companies.
• 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.
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• Pharmaceutical companies also have legal obligations to monitor, collect, manage and
report on safety data, known collectively as their
'pharmacovigilance responsibilities'.
23. The DAEN contains information on adverse events reported following administration of a
medicine, including the COVID-19 vaccines. As at 19 August 2021, the TGA has reduced the time
between adverse event reports being accepted into our database and published on the DAEN
from 90 days to 14 days. This decision was made in response to the strong public interest in
adverse event reports relating to COVID-19 vaccinations and allows reports for vaccines publicly
available more quickly.
24. All adverse event reports submitted to the TGA are evaluated, duplicate reports are rejected,
and the information contained therein is uploaded to the DAEN. You can search the DAEN for
“COVID” in the medicines report section, available here:
https://apps.tga.gov.au/PROD/DAEN/daen-report.aspx.
25. 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
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
26. 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.
27. 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.
28. Therefore, I consider that insofar as any interest is served by the release of the documents in
question, the public interest in evidence supporting the safety and efficacy of COVID-19
vaccines in Australia has already been met through the publication of the supporting
regulatory documents and the publicly available materials outlined above.
29. I find that the balance of interests does not favour the expenditure of considerable resources
by the TGA. The above diversion of TGA resources would, in my view, be substantial, and is
likely to cause serious delays to, and potentially compromise, the TGA’s performance of its
regulatory functions under the
Therapeutic Goods Act 1989.
30. Having regard to the importance of the prompt and proper performance of the TGA’s
regulatory functions, I consider that this diversion of resources would be unreasonable in the
circumstances.
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Notification of request consultation process
31. I am notifying you of my intention to refuse to give access to the documents that are within
scope of your request.
32. Before deciding to refuse access to documents, 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.
33. 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.
34. 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.
35. 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.
36. 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.
37. 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
Elspeth Kay
Assistant Secretary
Pharmacovigilance Branch
Therapeutic Goods Administration
Department of Health
18 February 2022
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Document Outline