TRIM Ref: D19-6575937
Karine McKerrell
Email:
xxxxxxxxxxxxxxxxxxxxxxxxx@xxxxxxxxxxx.xxx.xx
Dear Ms McKerrell
FREEDOM OF INFORMATION REQUEST FOI 1435
Request Consultation Process
I refer to your request dated 2 December 2019 under the
Freedom of Information Act 1982 (the FOI
Act) and subsequent correspondence between you and the TGA in which the scope of your request
was clarified as being for access to the following documents:
“I request documents pertaining to the evaluation process of licensing the fol owing vaccines on the
Australian market:
M-M-R II
PRIORIX
PROQUAD
PRIORIX TETRA
ENGERIX-B
INFANRIX HEXA
Public Assessment Reports/Clinical Evaluation extracts for these vaccines are not on the TGA
website. I request these documents, including clinical trial data in your possession…
I understand as per email correspondence I have received, that AusPARS had not been introduced at
the time these vaccines were licensed. I therefore would like to make acknowledgment of that in
relation to this FOI request, and still request any documents that pertain to the evaluation process
prior to their introduction on the Australian market, including clinical data.”
Decision Maker
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
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 approximately 13,200
relevant pages, that would have to be examined for relevance to your request. We note that, due to the
age of some of the vaccines, many of these files are still in paper form and further, that these are likely
to fall within the Open Access period as defined in the
Archives Act 1983.
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.
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 entitled under section 24AA(2)
of the FOI Act to consider the resources that would have to be used in the following activities:
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
•
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).
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 of 2 December 2019 including the terms of the FOI
request;
•
the estimated volume of documents involved and the work involved in processing
them. Preliminary estimates from the relevant line areas of the TGA identified 10 offsite
archive boxes, each containing at least 1,200 pages each for one vaccine alone (i.e. an
approximate total of 12,000 pages). A search and retrieval has not been undertaken for
the four other vaccines mentioned in your request, nor the previous versions of
vaccines not currently on the NIP (but each vaccine is likely to yield similar results);
•
the amount of time that would be required to examine all files to identify, in the first
instance, the portions of the application dossiers which contain the most relevant
documents for each vaccine (this work would require the attention of specialist officer
or officers who have competing responsibilities);
•
there are additional areas where searches have not been completed which are likely to
have additional relevant documents and therefore the total number of relevant
documents is likely to be higher than the estimate;
•
the need to prepare a schedule detailing all relevant documents;
•
the fact that each of those 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 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; and
•
the need to prepare at least two (2) third party decision letters and associated
schedules per vaccine (i.e 12 third parties), should any third parties object to the
proposed release of their information.
Taking into account these matters, I have prepared an estimate of charges in relation to your request.
For that purpose, I have:
•
taken a conservative approach of attributing 3,000 pages, both electronic and hard
copy for each individual vaccine;
•
considered the time required to undertake the consultation process with the two (2)
potential third parties for each individual vaccine;
•
considered the time already taken to perform searches for potentially relevant
documents and the additional time required to complete the remaining searches;
2
Based on my conclusion that the processing of your request could take approximately 207.42 hours, I
consider your request to be an unreasonable diversion of the TGA’s resources to process in its current
form. Further, I estimate that the charges that may be imposed on you for processing your request (as
calculated in accordance with the Schedule to the
Freedom of Information (Charges) Regulations 2019),
may, based on the estimated number of hours, exceed $4,338.33.
Notification of request consultation process
I am notifying you of my intention to refuse to give access to the documents that come within the
scope of your request.
I am satisfied that, because of the breadth of your request and the time required to identify potentially
relevant documents, 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.
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.
Accordingly, you are now afforded fourteen calendar (14) days from your receipt of this letter in
which to contact the TGA to discuss a revision of the scope of your request. If you wish to refine the
scope of your request you may contact the FOI team on (02) 6289 4630 or at xxx.xxx@xxx.xxx.xx.
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 FOI request (please
note that these are suggestions only and do not guarantee the practical refusal reason/s will no longer
exist):
• Choosing only one vaccine of interest (by brand name) and/or
• Identifying if there’s a relevant time period of interest (e.g. at the time of registration, or post-
market for a particular year) and/or
• Seeking clinical evaluation reports and/or delegate overviews.
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.
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
<signed electronical y>
Adrian Bootes
Assistant Secretary
Prescription Medicines Authorisation Branch
Therapeutic Goods Administration
20 December 2019
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Document Outline
