Therapeutic Goods Administration Approvals for Australian Defence Force Use of Tafenoquine in Bougainville and Timor Leste, 1999-2001

Stuart McCarthy made this Freedom of Information request to Therapeutic Goods Administration

Response to this request is long overdue. By law, under all circumstances, Therapeutic Goods Administration should have responded by now (details). You can complain by requesting an internal review.

From: Stuart McCarthy

Delivered

Dear Therapeutic Goods Administration staff,

During the period 1999-2001 the Australian Defence Force (ADF) administered the anti-malarial drug tafenoquine (aka "etaquine") to military personnel serving on operations in Bougainville and Timor Leste, including periods of time in Australia prior to and after their overseas deployment.[1] Tafenoquine has never been registered by the Therapeutic Goods Administration (TGA).[2] The drug has since been found by scientists from the Walter Reed Army Institute for Research to be "more neurotoxic than mefloquine",[3] which is a similar synthetic quinoline drug able to cause a chronic central nervous system toxicity syndrome.[4]

I hereby request the TGA to provide documents relating to any approvals for the ADF or Department of Defence to administer tafenoquine to Australian personnel during this period, including but not limited to:

a. Requests from ADF or Defence officials for TGA approval to use tafenoquine.

b. Minutes of meetings, records of conversations, or other correspondence between TGA and Defence officials, relating to such requests.

c. Internal TGA correspondence relating to proposed Defence use of tafenoquine, including minutes of meetings, records of conversation or emails.

d. Correspondence between TGA officials and GlaxoSmithKline relating to the proposed use of tafenoquine.

e. Written approvals by the TGA for Defence use of tafenoquine.

f. Reports from Defence officials to the TGA relating to adverse events experienced by ADF personnel administered tafenoquine during this period.

Yours faithfully,

Stuart McCarthy

References:

1. P. E. Nasveld, Tafenoquine in the prophylaxis and treatment of malaria in Australian Defence Force personnel, PhD thesis, James Cook University, 2011. http://researchonline.jcu.edu.au/29749/

2. R. J. Griggs, Response to Fairfax reporting on the use of tafenoquine in the ADF, Department of Defence, 2 May 2016. http://news.defence.gov.au/2016/05/02/re...

3. R. Agboruche, D. Yourick and D. Caridha, In-Vitro Toxicity Assessment of Antimalarial Drugs on Cultured Embryonic Rat Neurons, Macrophage (RAW 264.7), and Kidney Cells (VERO- CCl-81), 2009. https://d3gn0r3afghep.cloudfront.net/foi...

4. R. L. Nevin, Idiosyncratic quinoline central nervous system toxicity: historical insights into the chronic neurological sequelae of mefloquine, International Journal for Parasitology: Drugs and Drug Resistance, vol. 4, no. 2, pp. 118-125, 2014. http://www.sciencedirect.com/science/art...

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From: FOI
Therapeutic Goods Administration

Attention: Stuart McCarthy

FREEDOM OF INFORMATION REQUEST – NOTIFICATION OF RECEIPT

I am writing to notify you that the Department of Health (Department) has received your request (in your below email) for access to documents under the Freedom of Information Act 1982 (FOI Act).

The Department will take all reasonable steps to notify you of a decision no later than 30 calendar days after the date your request was received. You will be contacted where a charge is applied for processing your request or if we need to consult a third party.

Unless you advise otherwise, duplicate documents and Commonwealth employee names and contact details below Senior Executive Service level and mobile telephone numbers of all staff will be excluded from the scope of your request.

You can contact the FOI Unit on (02) 6289 1666, or via email at [email address], should you have any enquiries.

Kind regards
FOI Officer

FOI & Aged Care Parliamentary Section
Ministerial, Parliamentary, Executive Support and Governance Branch
People, Capability and Communication Division
Australian Government Department of Health
T: (02) 6289 1666 | E: [TGA request email]

PO Box 9848, Canberra ACT 2601, Australia

The Department of Health acknowledges the traditional owners of country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to elders both past and present.

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Stuart McCarthy left an annotation ()

This request follows a recent newspaper article* highlighting potentially serious regulatory breaches by Defence in its use of the unregistered drug tafenoquine in clinical drug trials in 2000-01. The article quotes a TGA spokesperson:

"Were the TGA to become aware that unregistered products were being supplied without obtaining appropriate exemption, the matter would be investigated."

*Henry Belot, Therapeutic Goods Administration warned military doctors before using experimental drug on soldiers, Canberra Times, 29 April 2016. http://www.canberratimes.com.au/national...

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From: TGA FOI


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Dear Stuart

 

Thank you for your FOI request which was received by the Therapeutic Goods
Administration on 4 May 2016.

 

I am writing to inform you that it appears that the scope of your request
may be too voluminous.

 

In order to reduce your scope, could you please advise of the specific
information that you seek, such as:

specific documents

 

For example, you may wish to consider submitting the following scope:

 

“I hereby request the TGA to provide documents relating to any approvals
for the ADF or Department of Defence to administer tafenoquine to
Australian personnel during 1999-2001, specifically:

 

a. Requests from ADF or Defence officials for TGA approval to use
tafenoquine.

 

b. Minutes of meetings, records of conversations, or other correspondence
between TGA and Defence officials, relating to such requests.

 

c. Internal TGA correspondence relating to proposed Defence use of
tafenoquine, including minutes of meetings, records of conversation or
emails.

 

d. Correspondence between TGA officials and GlaxoSmithKline relating to
the proposed use of tafenoquine.

 

e. Written approvals by the TGA for Defence use of tafenoquine.

 

f. Reports from Defence officials to the TGA relating to adverse events
experienced by ADF personnel administered tafenoquine during this period.”

 

Please note that at this early stage, this scope is a sample only, and the
TGA is unable to advise on how many documents (if any) would be returned
if a search and retrieval was conducted.

 

Please don't hesitate to contact me if you have any questions or if you
would like to discuss this.

 

Kind regards

 

Freedom of Information

Reporting and Collaborative Services Section

Regulatory Engagement and Planning Branch

Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [1][email address]

 

[2]cid:image004.png@01D10B4F.695253A0

 

 

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From: Stuart McCarthy

Delivered

Dear TGA FOI staff,

Thankyou for your helpful reply. The refined scope that you suggest in your email is exactly the information I am seeking. The background and references in my initial email should hopefully assist with a file search, specifically the documented use of tafenoquine by the ADF during clinical trials conducted in Bougainville (Papua New Guinea) 1999 and Timor Leste (formerly East Timor) 2000-01, noting that the drug was also administered to those personnel in Australia immediately prior to and after their deployment to those countries.

Another smaller tafenoquine study was conducted by the ADF during this period. That study was for tafenoquine in the treatment of recurrent vivax malaria. Given that TGA documents relating to that study have recently been made public via the media I do not need access to those documents via this FOI request.

I confirm the following scope of this request:

I hereby request the TGA to provide documents relating to any approvals for the ADF or Department of Defence to administer tafenoquine to Australian personnel during 1999-2001, specifically:

a. Requests from ADF or Defence officials for TGA approval to use tafenoquine.

b. Minutes of meetings, records of conversations, or other correspondence between TGA and Defence officials, relating to such requests.

c. Internal TGA correspondence relating to proposed Defence use of tafenoquine, including minutes of meetings, records of conversation or emails.

d. Correspondence between TGA officials and GlaxoSmithKline relating to the proposed use of tafenoquine.

e. Written approvals by the TGA for Defence use of tafenoquine.

f. Reports from Defence officials to the TGA relating to adverse events experienced by ADF personnel administered tafenoquine during this period.

In terms of prioritising this request, the most important documents I am seeking are any requests from ADF or Defence officials (item "a" above) and any written approvals (or denials) of those requests by the TGA (item "e") above. I would be happy to further revise this overall FOI request once we have determined whether such documents do or do not exist in TGA records.

Thankyou again for your assistance.

Yours sincerely,

Stuart McCarthy

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From: TGA FOI


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Dear Mr McCarthy,

 

I am currently working with the line area to conduct a search for
documents relevant to your request.

With regards to the scope of your request, your email below now makes
mention of clinical trials. Documents relating to the product in a
clinical trials setting changes the scope of your request. Products not
included on the register (i.e. unapproved) can be accessed via the
exemptions avenues afforded under the Therapeutic Goods Act such as the
Special Access Scheme (SAS) and Clinical Trials Scheme (CTN/CTX).

 

Below are links to information on the TGA website regarding the clinical
trial notification scheme and also the special access scheme which may be
useful in understanding the type of documentations involved.

[1]https://www.tga.gov.au/clinical-trials-g...

 

[2]https://www.tga.gov.au/form/special-acce...

 

Could you please clarify as soon as possible whether you are looking for
documents relating to a clinical trial notification or documents about an
approval under the special access scheme?

 

If you only require clinical trials documents then you could consider
revising the scope of your request to the following:

 

“Any clinical trials notification and TGA acknowledgement involving the
use of tafenoquine submitted by the ADF during clinical trials conducted
in Bougainville (Papua New Guinea) 1999 and Timor Leste (formerly East
Timor) 2000-01, noting that the drug was also administered to those
personnel in Australia immediately prior to and after their deployment to
those countries.”

 

Alternatively, the above sentence could be used as an additional dot point
to your current scope.

 

Please let me know how you would like to proceed.

 

Kind regards

 

 

Freedom of Information
02 6232 8664

                   

Reporting & Collaborative Services Section

Regulatory Engagement & Planning Branch

Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [3][email address]

[4]cid:image003.gif@01CFA69C.488B9550

 

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From: Stuart McCarthy

Delivered

Dear TGA FOI,

Thankyou again for your reply, requesting clarification as to the scope of my request, particularly whether tafenoquine was used by the ADF in clinical trials.

Publicly available reports do suggest that the ADF's use of tafenoquine in Bougainville 1999 and Timor 2001-2002 was as part of clinical trials.[1-3] These reports indicate that the trials were approved by the Australian Defence Human Research Ethics Committee (ADHREC) but make no reference to TGA approval/s. Recent media reporting[4] of the smaller trial to which I referred in my earlier email[5] suggest that TGA officials had approved the ADF's use of the drug in a clinical trial but subsequently rescinded that approval, quoting a letter from the TGA's director of drug safety Dr Leonie Hunt:

"It has been brought to my attention that you do not satisfy these requirements and therefore the authorisation should not have been issued. Accordingly you are no longer authorised to supply or prescribe tafenoquine for use in defence personnel for the treatment of recurrent vivax malaria."

The media article then states that "The doctors were eventually granted the drug for 'compassionate use' under a special access scheme that judged patient needs on a case-by-case basis."

Although it appears that tafenoquine was used in Bougainville and Timor for the specific purpose of clinical trials, it is unclear whether Defence was granted the appropriate approvals, either as clinical trials, under the special access scheme, or some other provision. Therefore the scope of the FOI request in my previous email remains valid, i.e. I am endeavouring to find TGA documents relating to ADF use of tafenoquine in Bougainville and Timor during that period, for any purpose.

In order to satisfy this FOI request, my suggestion would be to first confirm whether the TGA approved ADF use of tafenoquine in clinical trials, then if this was not the case, to determine whether approvals were granted under the special access scheme or other provisions.

Yours sincerely,

Stuart McCarthy

References:

1. P. E. Nasveld, Tafenoquine in the prophylaxis and treatment of malaria in Australian Defence Force personnel, PhD thesis, James Cook University, 2011. http://researchonline.jcu.edu.au/29749/

2. P. E. Nasveld, M. D. Edstein, M. Reid et al., Randomized, double-blind study of the safety, tolerability, and efficacy of tafenoquine versus mefloquine for malaria prophylaxis in nonimmune subjects, Antimicrobial Agents and Chemotherapy, vol. 54, no. 2, pp. 792–798, 2010. http://aac.asm.org/content/54/2/792.long

3. P. Nasveld, S. Kitchener, M. Edstein and K. Rieckmann, Comparison of tafenpquine (WR238605) and primaquine in the post-exposure (terminal) prophylaxis of vivax malaria in Australian Defence Force personnel, Transactions of the Royal Society of Tropical Medicine and Hygiene, vol. 96, no. 6, pp. 683-684, 2002. https://www.researchgate.net/publication...

4. H. Belot, Therapeutic Goods Administration warned military doctors before using experimental drug on soldiers, Sydney Morning Herald, 29 April 2016. http://www.smh.com.au/national/therapeut...

5. S. Kitchener, P. Nasveld and M. Edstein, Tafenoquine for the treatment of recurrent Plasmodium vivax malaria, American Journal of Tropical Medicine & Hygiene, vol. 76, no. 3, pp. 494-6, 2007. http://www.ncbi.nlm.nih.gov/pubmed/17360...

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From: TGA FOI


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Dear Mr McCarthy,

 

The TGA is currently in the process of searching for relevant documents in
relation to your FOI request.

 

Unfortunately due to the complexity and age of the documents involved in
your request as well as the time taken to reach a suitable scope, it has
become apparent that the TGA may be unable to meet the current deadline
for your request.

 

I would be grateful if you could please consider agreeing to an extension
(under section 15AA) of (30) days for the processing of your request.

 

Thank you for your consideration of this matter.

 

Please do not hesitate to contact me if you have any questions.

 

Kind regards

Liz

 

Freedom of Information
Liz Santolin 02 6232 8664

Reporting and Collaborative Services Section

Regulatory Engagement and Planning Branch

Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [1][email address]

 

[2]cid:image004.png@01D10B4F.695253A0

 

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From: Ben Kirkwood


Attachment Decision Letter to Requestor 15AB RQ16 02271 1.pdf
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Dear Mr McCarthy

Extension of time request under s 15AB

On 3 June 2016, the Therapeutic Goods Administration (TGA) requested
further time to make a decision on your FOI request of 4 May 2016.

This request was on the basis that the processing period is insufficient
to deal adequately with this FOI request, because it is complex.

As a delegate of the acting Information Commissioner, I am authorised to
make decisions on requests for extensions of time under s 15AB of the
Freedom of Information Act 1982 (Cth) (the FOI Act). I have decided to
grant the TGA an extension of time of 30 days to 4 July 2016 to process
your FOI request. This decision has been made under s 15AB(2) of the FOI
Act. A copy of the decision is attached.

Contact

If you would like to discuss this matter you can contact me on the number
below on Tuesday and Wednesdays. Alternatively, I can be reached by return
email. Please quote the reference number RQ16/02271.

Kind regards

 

Ben Kirkwood |Assistant Merit Review & Investigation Officer

Dispute Resolution Branch

Office of the Australian Information Commissioner

GPO Box 5218 SYDNEY NSW 2001 | [1]www.oaic.gov.au

Phone:  +61 2 9284 9615 | Facsimile: +61 2 9284 9666 

Email: [2][email address]

 

I am in the office on Tuesday and Wednesdays. I work remotely on Mondays.

 

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From: Stuart McCarthy

Delivered

Dear Mr Kirkwood,

Thankyou for advising me of this extension of time.

I look forward to seeing the TGA response to my FOI request by 4 July 2016.

Yours sincerely,

Stuart McCarthy

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Stuart McCarthy left an annotation ()

Excerpts from the Commonwealth Therapeutic Goods Act 1989

http://www.austlii.edu.au/au/legis/cth/c...

----------------------------------------

S 9.A.(5)  The Minister may, by notice published in the Gazette or on the Department's website:

(a)  require that specified therapeutic goods be included in the part of the Register for listed goods; and

(b)  specify the conditions subject to which such goods may be included in that part of the Register.

----------------------------------------

Exemptions for special and experimental uses

S 19.(1)  The Secretary may, by notice in writing, grant an approval to a person for the importation into, or the exportation from, Australia or the supply in Australia of specified therapeutic goods that are not registered goods, listed goods or exempt goods:

(a)  for use in the treatment of another person; or

(b)  for use solely for experimental purposes in humans;

and such an approval may be given subject to such conditions as are specified in the notice of approval.

(2)  An application for an approval must be made to the Secretary and must:

(a)  in the case of an application for use of the kind referred to in paragraph (1)(a)--be accompanied by such information relating to the goods the subject of the application as is required by the Secretary; and

(b)  in the case of an application for use of the kind referred to in paragraph (1)(b):

(i)  be made in writing; and

(ii)  be accompanied by such information relating to the goods the subject of the application as is required by the Secretary; and

(iii)  be accompanied by the prescribed evaluation fee.

(3)  Without limiting the conditions to which an approval under subsection (1) may be made subject, those conditions may include a condition relating to the charges that may be made for the therapeutic goods to which the approval relates.

(4)  Where an application for an approval is made, the Secretary must, after having considered the application and, in the case of an application for the use of therapeutic goods for experimental purposes in humans, after having evaluated the information submitted with the application, notify the applicant of the decision on the application within 28 days of making the decision and, in the case of a decision not to grant the approval, of the reasons for the decision.

(4A)  The use by a person for experimental purposes in humans of specified therapeutic goods that are the subject of an approval granted to someone else under paragraph (1)(b) is subject to the conditions (if any) specified in the regulations relating to one or more of the following:

(a)  the preconditions on the use of the goods for those purposes;

    (b)  the principles to be followed in the use of the goods for those purposes;

    (c)  the monitoring of the use, and the results of the use, of the goods for those purposes;

    (d)  the circumstances in which the person must cease the use of the goods for those purposes.

(5)  The Secretary may, in writing, authorise a specified medical practitioner to supply:

(a)  specified therapeutic goods for use in the treatment of humans; or

    (b)  a specified class of such goods;

to the class or classes of recipients specified in the authority.

(5A)  An authority may be given subject to the conditions (if any) specified in the authority.

(5B)  The Secretary may impose conditions (or further conditions) on an authority given to a person under subsection (5) by giving to the person written notice of the conditions (or further conditions).

(6)  An authority under subsection (5) may only be given:

(a)  to a medical practitioner included in a class of medical practitioners prescribed by the regulations for the purposes of this paragraph; and

    (aa)  to a medical practitioner who has the approval of an ethics committee to supply the specified therapeutic goods or the specified class of such goods; and

    (b)  in relation to a class or classes of recipients prescribed by the regulations for the purposes of this paragraph.

Paragraph (aa) does not apply in the exceptional circumstances (if any) prescribed by the regulations for the purposes of this subsection.

(7)  The regulations may prescribe the circumstances in which therapeutic goods may be supplied under an authority under subsection (5).

(9)  In this section, medical practitioner means a person who is registered, in a State or internal Territory, as a medical practitioner.

----------------------------------------

Offence relating to wholesale supply

S.21. A person must not supply in Australia therapeutic goods for use in humans (other than listable devices), being goods of which the person is not a sponsor, to another person who is not the ultimate consumer of the goods unless:

(a)  the goods are registered goods or listed goods; or

      (b)  the goods are exempt goods; or

      (ba)  the goods are exempt under section 18A; or

      (c)  the goods are the subject of an approval or authority undersection 19; or

      (d)  the goods are the subject of an approval under section 19A.

Penalty:  120 penalty units.

----------------------------------------

General criminal offences relating to this Part

S21A.(12)  A person commits an offence if:

(a)  the person uses therapeutic goods; and

    (b)  the goods are used:

    (i)  in the treatment of another person; or

       (ii)  solely for experimental purposes in humans; and

    (c)  the goods are not:

        (i)  exempt goods; or

        (ii)  listed goods; or

        (iii)  registered goods; or

        (iv)  goods exempt under section 18A; or

        (v)  goods that are the subject of an approval under section 19A; and

      (d)  the goods are not used in accordance with:

       (i)  an approval or authority under section 19; or

         (ii)  a condition applicable under regulations made for the purposes of subsection 19(4A); and

       (e)  either:

         (i)  if the person used the goods in the treatment of another person--the use of the goods has resulted in, or will result in, harm or injury to that person; or

          (ii)  if the person used the goods solely for experimental purposes in humans--the use of the goods has resulted in, or will result in, harm or injury to any of those persons.

Penalty:  Imprisonment for 5 years or 4,000 penalty units, or both.

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Stuart McCarthy left an annotation ()

This 2004 paper by authors from the Army Malaria Institute explains how Defence obtained tafenoquine for the Bougainville clinical trial, making no reference to TGA approval:

"This was the first trial conducted on the use of tafenoquine to be conducted for the indication of post-exposure prophylaxis. The trial was sponsored by the ADF, with treatment courses of tafenoquine provided by SmithKline Beecham under their collaborative development program with the United States Army Medical Materiel Development Activity."

N.J. Elmes, S.J. Bennett and P.E. Nasveld, "Malaria in the Australian Defence Force: the Bougainville experience", ADF Health, vol. 5, no. 2, 2004. http://www.defence.gov.au/health/infocen...

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From: TGA FOI

Dear Mr McCarthy

As discussed, please provide information regarding additional clinical trial site and I will discuss with the relevant area of the TGA.

Kind regards
Liz

Freedom of Information
Reporting and Collaborative Services Section
Regulatory Engagement and Planning Branch
Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [email address]

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From: Brandon Chen


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Attachment Extension of time request under s 15AB RQ16 02482 SEC UNCLASSIFIED.html
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Attachment FW FOI222 1516 Tafenoquine SEC UNCLASSIFIED.txt
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Attachment Request for extension of time.docx
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Our reference: RQ16/02482

 

Mr Stuart McCarthy

Extension of time request under s 15AB

On 4 July 2016, the Department of Health (Department) requested further
time to make a decision on your FOI request of 13 May 2016.

This request was on the basis that the processing period is insufficient
to deal adequately with your request, because it is complex and/or
voluminous.

The Information Commissioner has decided to grant the Department an
extension of time of 21 days for this request, to 29 July 2016. This
decision has been made under s 15AB(2) of the Freedom of Information Act
1982 (Cth).

If you have any questions about this email, please contact me on 02 9284
9726 or via email [1][email address]. In all correspondence
please include reference number RQ16/02482.

Yours sincerely

 

Brandon Chen | Investigation and Review Officer | FOI Dispute Resolution

Office of the Australian Information Commissioner

GPO Box 5218 SYDNEY NSW 2001 | [2]www.oaic.gov.au

Phone:  +61 2 9284 9726 | Email: [3][email address]

 

Protecting information rights – advancing information policy

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From: Stuart McCarthy

Delivered

Dear Liz,

Sincere thanks again for your assistance with this FOI request.

This post on the IMVA website pieces together the publicly available information on the ADF tafenoquine clinical trials from 1998 to 2002. https://imvalliance.org/2016/07/09/scien...

Based on this information, the locations and numbers of ADF personnel administered tafenoquine during these trials are:

a. November 1998 to September 1999, members of the Peace Monitoring Group, Bougainville (Papua New Guinea) - 446 subjects.

b. 1999, "maritime operators", unknown location/s - at least 148 subjects.

c. February 2000, members of the 3 RAR battalion group, Timor Leste - 406 subjects.

d. 2000-2001, members of the 1 RAR battalion group, Timor Leste - 492 subjects.

e. 2001-2002, individual patients with relapsing vivax malaria, various locations in Australia - 31 subjects (documents for this trial are not included in this request).

Hopefully the information on the additional trials identified here will assist in fulfilling the FOI request.

Yours sincerely,

Stuart McCarthy

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From: TGA FOI

Dear Mr McCarthy

I have spoken to the line area, and they have estimated that an additional 10 files would need to be recalled to search for documents in the earlier time period (1998).
Generally we don't broaden FOI scopes once a request has been accepted, however in these circumstances it appears as though it would be beneficial to both you and TGA to include these documents in the search at this time.

There are a couple of options available:

- we can recall these files and include them in the search for the current FOI request, however we will require some additional time (approx. one week) should you wish to include these documents now; or

- we can recall the files and begin a new FOI request (separate to the current request).

I would be grateful if you could please, at your earliest convenience, indicate how you would like to proceed from here?

Kind regards
Liz

Freedom of Information
Liz Santolin 02 6232 8664

Reporting and Collaborative Services Section
Regulatory Engagement and Planning Branch
Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [email address]

---------------------------------------------------------------------------------------

From: Stuart McCarthy [mailto:[FOI #1916 email]]
Sent: Tuesday, 12 July 2016 8:41 AM
To: TGA FOI
Subject: RE: FOI222-1516 - Tafenoquine [SEC=UNCLASSIFIED]

Dear Liz,

Sincere thanks again for your assistance with this FOI request.

This post on the IMVA website pieces together the publicly available information on the ADF tafenoquine clinical trials from 1998 to 2002. https://imvalliance.org/2016/07/09/scien...

Based on this information, the locations and numbers of ADF personnel administered tafenoquine during these trials are:

a. November 1998 to September 1999, members of the Peace Monitoring Group, Bougainville (Papua New Guinea) - 446 subjects.

b. 1999, "maritime operators", unknown location/s - at least 148 subjects.

c. February 2000, members of the 3 RAR battalion group, Timor Leste - 406 subjects.

d. 2000-2001, members of the 1 RAR battalion group, Timor Leste - 492 subjects.

e. 2001-2002, individual patients with relapsing vivax malaria, various locations in Australia - 31 subjects (documents for this trial are not included in this request).

Hopefully the information on the additional trials identified here will assist in fulfilling the FOI request.

Yours sincerely,

Stuart McCarthy

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From: Stuart McCarthy

Delivered

Dear Liz,

Thankyou again for your assistance. I would be pleased to submit a separate FOI request for documents relating to the additional clinical trials which I identified in my previous email.

Yours sincerely,

Stuart McCarthy

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From: TGA FOI


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Attachment FOI222 1516 Estimate of Charges.pdf
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Dear Mr McCarthy,

 

Please find attached an estimate of charges in relation to your Freedom of
Information request.

 

Kind regards

Jodie

 

Freedom of Information
Liz Santolin 02 6232 8664

Jodie Russell 02 6232 8720
Karen Bedford 02 6232 8772

Heather Davidson 02 6232 8988

 

Reporting and Collaboration Services Section

Regulatory Engagement and Planning Branch

Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [1][email address]

 

[2]cid:image004.png@01D10B4F.695253A0

 

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From: TGA FOI


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Dear Mr McCarthy

 

I am writing in relation to the scope of your FOI request 222-1516. Can
you please clarify if you are seeking 'personal information' (e.g., the
names and/or contact details of any individuals) in the documents
requested?

Confirmation from you that you are not seeking personal information may
enable more timely and less costly processing of your request.  For
example, consultation with identified individuals can add to the time and
cost taken to process your request.

 

If you are not seeking access to personal information, you can simply
reply: 'no personal information requested'.

 

We look forward to hearing from you as soon as possible.

 

Kind regards

 

 

Freedom of Information
Liz Santolin 02 6232 8664

Jodie Russell 02 6232 8720
Karen Bedford 02 6232 8772

Heather Davidson 02 6232 8988

 

Reporting and Collaborative Services Section

Regulatory Engagement and Planning Branch

Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [1][email address]

 

[2]cid:image001.png@01D1D5D9.7DDEADA0

 

 

 

 

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From: Stuart McCarthy

Delivered

Dear Liz,

Thankyou for your emails advising of the TGA estimate of charges and seeking clarification regarding personal information.

The deposit of $212.57 has been paid to the TGA Commonwealth Bank account today via electronic funds transfer.

I am seeking some personal information as part of my request, as follows:

a. The names only (contact details not required) of senior Australian Defence Force personnel, including the rank of commander (RAN)/Lieutenant Colonel (Army)/Wing Commander (RAAF) and above. https://en.m.wikipedia.org/wiki/Australi...

b. The names only (contact details not required) of civilian Commonwealth Senior Executive Service (SES) officials.

I not seeking personal information on individuals who were not Commonwealth officials.

Yours sincerely,

Stuart McCarthy

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From: Stuart McCarthy

Delivered

Dear TGA FOI,

Please provide an update on the progess of this FOI request. By law, the TGA should have fulfilled this request two weeks ago.

Yours sincerely,

Stuart McCarthy

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From: TGA FOI

Dear Mr McCarthy,

Thank you for your email.

Following a review of the timeframes, it has become apparent that the due date for this request has indeed lapsed. We sincerely apologise for this oversight.

The TGA has made a request for an extension of time under section 15AC of the FOI Act with the Office of the Australian Information Commissioner in which to finalise your request. We are currently awaiting a response.

In the meantime, the TGA continues to process your request.

Again, we sincerely apologise for the oversight and any inconvenience caused.

If you have any questions, please do not hesitate to contact the FOI Team.

Kind regards,

Freedom of Information

Reporting and Collaborative Services Section
Regulatory Engagement and Planning Branch
Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [email address]

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From: Irene Nicolaou


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Our reference: RQ16/03541

Your reference: FOI 222-1516

Mr Stuart McCarthy

 

By email: [1][FOI #1916 email]

 

Dear Mr McCarthy

Extension of time request under s15AC

On 13 September 2016, the Therapeutic Goods Administration (the TGA)
requested further time to make a decision on your FOI request of 4 May
2016.

Section 15AC of the Freedom of Information Act 1982 (Cth) (the FOI Act)
allows the Information Commissioner to extend the processing time for an
FOI request where the initial decision period has ended and the agency or
Minister has not provided the applicant with notice of a decision. The TGA
has advised this Office they have not made a decision in the statutory
time period. The FOI Act deems that your request has been refused (deemed
refusal).

As a delegate of the Information Commissioner, I am authorised to make
decisions on requests for extensions of time under s 15AC(5) of the FOI
Act. I have decided to grant the TGA an extension of time to 21 September
2016 to process your request.

We note that this extension under s15AC of the FOI Act will mean that the
deemed refusal is taken never to have applied if the TGA makes a decision
on your request by 21 September 2016.

Such an extension can only be granted once and cannot be extended by a
variation. This extension under s15AC of the FOI Act means the TGA cannot
reimpose a charge.

If you would like to discuss this matter I can be contacted on 1300 363
992 or by email at [2][email address].  Please quote the
reference number RQ16/03541.

 

Yours sincerely

 

Irene Nicolaou | Assistant Investigation and Review Officer | Freedom of
Information Dispute Resolution

Office of the Australian Information Commissioner

Level 3, 175 Pitt Street, SYDNEY NSW 2000

GPO Box 5128 SYDNEY NSW 2001| [3]www.oaic.gov.au

Phone:  +61 2 9284 9605 | E-mail: [4][email address]

 

Protecting information rights – advancing information policy

 

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From: SANTOLIN, Elizabeth


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Dear Mr McCarthy

 

Please find attached correspondence in relation to your Freedom of
Information request.

 

Due to their size, the documents will be sent under cover of six (6)
emails.

 

If you have any questions, please do not hesitate to contact the FOI Team.

 

Kind regards

 

Freedom of Information

Reporting and Collaborative Services Section

Regulatory Engagement and Planning Branch

Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [1][email address]

 

[2]cid:image004.png@01D10B4F.695253A0

 

 

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From: SANTOLIN, Elizabeth


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Dear Mr McCarthy,

 

As per our previous email.

 

Kind regards,

 

Freedom of Information

Reporting and Collaborative Services Section

Regulatory Engagement and Planning Branch

Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [1][email address]

 

[2]cid:image004.png@01D10B4F.695253A0

 

 

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From: SANTOLIN, Elizabeth


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Dear Mr McCarthy,

 

As per our previous email.

 

Kind regards,

 

Freedom of Information

Reporting and Collaborative Services Section

Regulatory Engagement and Planning Branch

Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [1][email address]

 

[2]cid:image004.png@01D10B4F.695253A0

 

 

 

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From: SANTOLIN, Elizabeth


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Dear Mr McCarthy,

 

As per our previous email.

 

Kind regards,

 

Freedom of Information

Reporting and Collaborative Services Section

Regulatory Engagement and Planning Branch

Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [1][email address]

 

[2]cid:image004.png@01D10B4F.695253A0

 

 

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From: SANTOLIN, Elizabeth


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Dear Mr McCarthy,

 

As per our previous email.

 

Kind regards,

 

Freedom of Information

Reporting and Collaborative Services Section

Regulatory Engagement and Planning Branch

Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [1][email address]

 

[2]cid:image004.png@01D10B4F.695253A0

 

 

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From: SANTOLIN, Elizabeth


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Dear Mr McCarthy,

 

As per our previous email.

 

Kind regards,

 

Freedom of Information

Reporting and Collaborative Services Section

Regulatory Engagement and Planning Branch

Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [1][email address]

 

[2]cid:image004.png@01D10B4F.695253A0

 

 

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From: Carl English


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Our reference: RQ17/00727

Agency reference: FOI 13937

 

 

Mr Stuart McCarthy

By email: [FOI #1916 email]

 

Dear Mr McCarthy

Extension of time request under s15AB

On 15 March 2017, Department of Veterans' Affairs (the Department)
requested further time to make a decision on your FOI request of 14
February 2017.

This request was on the basis that the processing period is insufficient
to deal adequately with your request, because it is complex or voluminous.

The Information Commissioner has decided to grant the Department an
extension of time to process your request to 18 April 2017. This decision
has been made under s15AB(2) of the Freedom of Information Act 1982 (Cth)
(the FOI Act).

By granting further time it is anticipated that the Department will
provide a well-reasoned and better managed decision.

Contact

If you have any questions regarding this email please contact me on 02
9284 9745 or via email [email address]. Please quote OAIC
reference number RQ17/00727 in all correspondence.

Yours sincerely

Carl English | Assistant Review and Investigation Officer | Freedom of
Information Dispute Resolution

Office of the Australian Information Commissioner

GPO Box 5218 SYDNEY NSW 2001| [1]www.oaic.gov.au

Phone:  +61 2 9284 9745 | E-mail: [email address]

 

Protecting information rights – advancing information policy

[2]cid:image001.png@01D26682.9CE52410

 

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Things to do with this request

Anyone:
Therapeutic Goods Administration only: