Sarah via Right-to-Know
Email: xxxxxxxxxxxxxxxxxxxxxxxxxx@xxxxxxxxxxx.xxx.xx
Dear Sarah
FREEDOM OF INFORMATION REQUEST FOI 5361
Request Consultation Process
1. I refer to your request dated 23 August 2024 under the
Freedom of Information Act 1982 (the FOI
Act) for access to the following documents:
‘…I am writing regarding your Post-market review of spinal cord stimulation (SCS) devices.
May you please provide the fol owing information that was submitted by Saluda Medical, relating
to their Evoke Closed Loop Spinal Cord Stimulator:
- All domestic and international incidents, adverse events, complaints, and any investigations
undertaken, and corrective actions made as a result of these investigations.’
Decision Maker
2. I am the Therapeutic Goods Administration (TGA) officer authorised to make a decision on your
request under the FOI Act.
Requirement to undertake a request consultation process
3. Before deciding on the outcome of your request, I have decided 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.
4. For the reasons outlined in this letter, I am satisfied that, because of the number of documents
involved in your request, the number of third parties that would need to be consulted, and the
number of hours involved in considering exemptions and making a decision on the documents as
set out above, your request would substantially and unreasonably divert staff in regulatory areas
of the TGA who would be required to review and consider the documents and any submissions
provided by third parties on the documents, from the performance of their day-to-day functions.
5. The TGA has now undertaken a preliminary search and retrieval for documents coming within the
scope of your request. As a result, TGA officers have indicated that there are in excess of 220
relevant documents that would have to be processed for your request to be finalised.
6. 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.
7. A copy of the sections of the FOI Act that set out the consultation process (sections 24, 24AA and
24AB) is at
Attachment A.
PO Box 100 Woden ACT 2606 ABN 40 939 406 804
Phone: 1800 020 653 or 02 6289 4124 Fax: 02 6203 1605
Email:
xxxx@xxx.xxx.xx
https://www.tga.gov.au
8. 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 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 document).
9. In coming to a view that a practical refusal reason exists in relation to your request, I have had
regard to the following:
• the correspondence from you dated 23 August 2024, including the terms of the FOI request;
• the estimated volume of documents within scope of your request and the work involved in
processing them. Namely, preliminary estimates from the Medical Devices Surveillance Branch
of the TGA identified approximately 220 documents in relation to your request;
• the need to prepare a schedule detailing all relevant documents;
• that each of the documents may contain business and/or personal information, in relation to
which, consideration would need to be given about whether an exemption should be claimed
and whether consultation with third parties is required, and, if so, preparation of schedules for
the third party detailing all relevant documents;
• the number of affected third parties that would need to be consulted, as there are in excess of 90
third parties. 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 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;
• 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; and
• that any decision letter would need to list each document in an attachment setting out the
outcome of the consideration of whether exemptions apply.
10. Considering these matters, I have prepared an estimate of the time required to process your
request. For that purpose, I have:
• taken a conservative approach in considering the time required to undertake the consultation
process with half of the number of potential third parties;
• considered the time already taken to perform searches for potential y relevant documents and
the additional time required to complete the remaining searches; and
• estimated how long it might take to process 220 documents.
11. The estimate of charges calculator has calculated that the processing of this request could take at
least 106 hours. I consider that the number of documents estimated to fal within the scope of your
request, combined with the fact that much of the information is commercially confidential
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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.
12. 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 post-market
surveillance activities for medical devices. 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.
13. 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 (see paragraph 3.117 of the FOI Guidelines).
14. The time to review the 220 documents in detail to determine whether any of the documents or
parts of the documents could be characterised as exempt, and then redacting the material, would
be a substantial and unreasonable diversion of the TGA’s resources.
15. I find that the balance of interests does not favour the expenditure of considerable resources by the
TGA. I am satisfied that the diversion of resources to provide documents in response to your request
is not reasonable.
Notification of request consultation process
16. As outlined above, I have decided 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.
17. 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. The processing time for
your request has been set aside to allow for the request consultation period.
18. 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.
You may wish to consider the following suggestions to revise the scope of your request (Please
note that these are a suggestion only and does not guarantee the practical refusal reason will no
longer exist):
• revising the scope of your FOI request to the response/s submitted by Saluda Medical Pty Ltd
in response to the TGA’s post-market review of spinal cord stimulators for their Evoke Closed
Loop Spinal Cord Stimulator (ARTG 336330); and/or
• excluding Device Incident Reports from the scope of your request; and/or
• specifying a timeframe for the request.
19. Should you require further time to consider submitting a revised scope, you are welcome to
request an extension to the consultation period in writing to the TGA, in accordance with
subsection 24AB(5) of the FOI Act.
20. 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 your scope, your request is taken to have been withdrawn.
21. If you wish to refine the scope of your request, you may contact the FOI team on
(02) 6289 4630 or
at xxxxxx@xxxxxx.xxx.xx.
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22. 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
Dr Marcelle Noja
Assistant Secretary
Medical Devices Surveillance Branch
Therapeutic Goods Administration
11 September 2024
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Document Outline
