D21 3019760 FOI 2598 Request consultation letter Shakespeare Final.pdf

TRIM Ref: D21-3019760
Mr Daniel Shakespeare
By Email: xxxxxxxxxxxxxxxxxxxxxxxxx@xxxxxxxxxxx.xxx.xx

Dear Mr Shakespeare
FREEDOM OF INFORMATION REQUEST FOI 2598
Request Consultation Process

1.  I refer to your request dated 6 August 2021 under the Freedom of Information Act 1982 (the
FOI Act) in which you made the following request:

“Can I please request the fol owing data pertaining to the stated 425 reports received;

1. Age and sex of the patient for each report (this data alone cannot be used to identify patients)
2. The source of each report ie whether the report was made by a practitioner or member of the
public.”

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 and otherwise publicly available
3.  With respect to your request, the TGA does not hold a distinct document which contains the
“age and sex of the patient for each report” and the “the source of each report” for the 425
deaths with temporal links to the COVID-19 vaccines.

4.  The TGA is not required under the FOI Act to create documents providing specific
information. The information you have requested is contained within numerous reports and
other supplementary documents provided to the TGA. To satisfy your request, the TGA would
need to identify and consider each report.

5.  By way of background, the TGA receives at least one report for each adverse event recorded.
It is not uncommon for one adverse event to be reported multiple times, often by both a
medical practitioner and representatives for the deceased person. This means that a number
of reports are rejected for duplication (for example, there are approximately 115 duplicative
reports in addition to the 425 reports you have requested). As you are requesting
information relating to the source of all reports, the TGA would need to revisit the duplicative

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

reports to determine whether the deaths were reported by members of the public, medical
practitioners, coroners, or State or Territory health authorities, for example.

6.  Therefore, to satisfy your request, the TGA would need to process at least 425 documents and
approximately 115 duplicative reports. For this reason, and for reasons explained further
below, processing your request would be an unreasonable diversion of the TGA’s time and
resources.

7.  As your request is currently too voluminous to process, the TGA has not continued to process
your request.

Requirement to undertake a request consultation
8.  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 substantial y and
unreasonably divert the resources of the TGA from its other operations.

9.  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).

10.  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 6 August 2021.
•  the estimated volume of documents involved, and the work involved in processing them,
namely, the 425 reports, plus approximately 115 duplicate reports, in relation to deaths
investigated to determine any temporal links to the COVID-19 vaccine. The total number of
pages is estimated at 1000 pages.
•  this is also particularly relevant as the data includes sensitive health information that may
require consultation with the third parties or the representatives of deceased persons,
even with personal information redacted. 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).
•  as you would appreciate, if consultation with third parties is required, 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 taking these submissions into account. Also, 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 clinical medical officers,
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

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.

11.  Taking into account these matters, I have:
•  considered the time required to undertake the consultation process with at least 425 third
parties;
•  considered the time already taken to perform searches for potentially relevant documents;
and
•  estimated how long it might take to process the 425 reports containing approximately
1000 pages.

12.  I consider that the number of pages estimated to fall within the scope of your request,
combined with the possible need to consult with a number of third parties and the fact that
much of the information is sensitive health information, and 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, for the following reasons, that the work involved in processing this request would
be an unreasonable diversion of the TGA’s resources, including TGA’s officers engaged in
safety monitoring of medicines and vaccines. As to the critical work that these officers
perform, I note that 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.

14.  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 involved in supporting evaluators, the
broader operations of the TGA’s medicines safety monitoring business and processing other
FOI requests. In this regard, the FOI Guidelines state that a relevant matter in deciding
whether 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 (my emphasis) (see
paragraph 3.117 of the FOI Guidelines).

15.  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 and the number of third
  parties.

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

Guidance on accessing the TGA’s publicly available information
16.  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.

17.  To a very large degree, the public interest is met through the publication of information in the
supporting regulatory documents, including the Australian Public Assessment Report
(AusPAR), the Product Information (PI), and the other information that is publicly available
in the Database of Adverse Event Notifications (DAEN) and the weekly safety reports. The PI
is the key source of information for health professionals as it provides a summary of the
scientific information relevant to the safe and effective use of a prescription medicine,
including vaccines. The PI is approved by the TGA, and sponsors must submit an application
to the TGA to make any change to the PI. The PI includes information on adverse events
which were observed in clinical trials, as well as those observed from post-market
surveillance. The TGA works with COVID-19 vaccine sponsors to ensure the PI remains up to
date and can mandate updates to the safety information included in the PI.

18.  The AusPARs and PIs are available for each provisionally approved vaccine here:
https://www.tga.gov.au/covid-19-vaccine-provisional-registrations.

19.  In addition to the PI, the TGA publishes a weekly safety report for COVID-19 vaccines and
makes adverse event information available to the public through the DAEN. 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.

20.  Notably, the DAEN contains information on the age and gender of the patient, as well as the
medicines reported as being taken and the reaction. The DAEN can be accessed here:
https://apps.tga.gov.au/Prod/daen/daen-entry.aspx.

21.  Due to strong public interest of and interest in side effects relating to COVID-19 vaccinations,
the TGA has now reduced the time between adverse event reports being accepted into the
TGA database and published in the DAEN from 90 days to 14 days. The DAEN reports from 1
January 1971 up to 14 days prior to the date of access. Reports will now be made public prior
to in-depth TGA analysis of the data to check for patterns of adverse events that may or may
not indicate a safety issue.

22.  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. For example, to conduct a search by active
ingredient, tick the box for each trade name containing the active ingredient.

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.  Similar adverse event data is also made available by international regulators, for example:
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

•  The US Food and Drug Administration’s Vaccine Adverse Event Reporting System:
https://vaers.hhs.gov/
•  The UK Medicines and Healthcare products Regulatory Agency’s Yellow Card reporting:
https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-
reactions
•  The European Medicines Agency EudraVigilance (European database of suspected adverse
drug reaction reports): https://www.adrreports.eu/en/

25.  I also note that AusVaxSafety is an active vaccine safety surveillance system that
complements the TGA’s enhanced safety surveillance activities. Active vaccine safety
surveillance uses SMS and a short survey to collect reports of AEFI directly from a subset of
people receiving the vaccines. AusVaxSafety is an Australian Government-funded system that
shares its findings with the TGA to assist safety investigations and responses. Please see
details of AusVaxSafety’s latest COVID-19 safety data available here:
https://www.ausvaxsafety.org.au/safety-data/covid-19-vaccines

26.  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, as well as through publication of information regarding deaths and
adverse events on the DAEN and the COVID-19 weekly safety reports. The changes to the
release of the DAEN-level data to the public sooner than the 90-days will further serve to
benefit the public interest in this information.

27.  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.

28.  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.

Notification of request consultation process
29.  I am notifying you of my intention to refuse to give access to the documents that come within
the scope of your request.

30.  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.

31.  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.

32.  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.

33.  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 the scope of this request, your request is taken to have
been withdrawn.
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

34.  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.

35.  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
Acting Assistant Secretary
Pharmacovigilance & Special Access Branch
Therapeutic Goods Administration
27 August 2021

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