information on Spinal Cord Stimulator revisions

This request has been withdrawn by the person who made it. There may be an explanation in the correspondence below.

Dear Department of Health,

Please provide any data or information provided in the form of report(s), spreadsheet(s), document(s), email(s) and/or correspondence regarding Spinal Cord Stimulation revisions provided to the Therapeutic Goods Administration by Private Healthcare Australia in April and May 2024.

Yours faithfully,

Kath

TGA FOI, Department of Health

1 Attachment

Dear Kath

 

FREEDOM OF INFORMATION REQUEST – NOTIFICATION OF RECEIPT

 

I am writing to notify you that the Therapeutic Goods Administration
(Department of Health and Aged Care) has received your request for access
to documents under the Freedom of Information Act 1982 (FOI Act) as
follows:

 

‘Please provide any data or information provided in the form of report(s),
spreadsheet(s), document(s), email(s) and/or correspondence regarding
Spinal Cord Stimulation revisions provided to the Therapeutic Goods
Administration by Private Healthcare Australia in April and May 2024.’

 

The timeframe for your request is from 01 April 2024 to 31 May 2024.

 

Under section 15(5)(b) of the FOI Act, the agency has 30 calendar days
from the date your request was received in which to provide a decision in
response to your request for access. A decision is currently due on or
before 17 July 2024. Due to the statutory processing time afforded under
the FOI Act in which to provide you with a decision in relation to your
FOI request, we would be grateful if you could please monitor your emails
periodically for updates regarding your request.

 

Where there is requirement to undertake consultation with affected third
parties, this timeframe is extended by a further 30 days. It may also be
extended in certain circumstances, including with your agreement or where
the Department applies to the Office of the Australian Information
Commissioner for an extension.

 

Unless you advise otherwise, draft and duplicate documents, Commonwealth
employee names and contact details of staff below Senior Executive Service
level, internal group email addresses and mobile telephone numbers of all
staff will be excluded from the scope of your request under section
22(1)(a)(ii) of the FOI Act.

 

Disclosure Log Publication:

The TGA is required under section 11C of the FOI Act to publish on its
website, or otherwise make available, documents released to an applicant
in response to an FOI request, unless exceptional circumstances apply. The
TGA publishes these documents on the FOI Disclosure Log at [1]FOI
Disclosure Log | Therapeutic Goods Administration. You can find more
information about the Disclosure Log at [2]OAIC FOI Guidelines |
Disclosure Logs.

 

Personal information:

I note from your request that you have not indicated that you wish to seek
access to the personal information of third parties (e.g. the names and
contact details of individuals, or any information that could reasonably
identify an individual). Seeking this information may require the
Department to consult with the identified individuals. This will increase
the time taken to process your request and the costs involved. As such, we
would be grateful if you would consider removing the personal information
of third parties from the scope of your request. 

 

In addition, please note that if the decision maker decides that you are
liable to pay a charge in relation to your request then this timeframe is
extended pending payment of a deposit. You will be notified by the
Department if you are liable to pay a charge and/or if third party
consultation is required.

 

I would be grateful if you could respond to this email by COB Friday 21
June so that we may continue processing your request.

 

If you have any queries, please contact the FOI team on (02) 6289 4630, or
via email at [3][email address].

 

Kind regards

Emilee

 

Freedom of Information

Karen | Emily | Tara | Christina | Lily| Emilee| Russel

 

Therapeutic Goods Administration

Australian Government Department of Health and Aged Care

T: 02 6289 4630 | E: [4][email address]

PO Box 100, Woden ACT 2606, Australia

Web: [5]www.tga.gov.au

 

Important: This transmission is intended only for the use of the addressee
and may contain confidential or legally privileged information. If you are
not the intended recipient, you are notified that any use or dissemination
of this communication is strictly prohibited. If you receive this
transmission in error please notify the author immediately and delete all
copies of this transmission.

 

The Department of Health and Aged Care acknowledges the Traditional
Custodians of Australia and their continued connection to land, sea and
community. We pay our respects to all Elders past and present.

 

REMINDER: Think before you click! This email originated from outside our
organisation. Only click links or open attachments if you recognise the
sender and know the content is safe.

Dear Department of Health,

 

Please provide any data or information provided in the form of report(s),
spreadsheet(s), document(s), email(s) and/or correspondence regarding
Spinal Cord Stimulation revisions provided to the Therapeutic Goods
Administration by Private Healthcare Australia in April and May 2024.

 

Yours faithfully,

 

Kath

 

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

 

Please use this email address for all replies to this request:

[6][FOI #11522 email]

 

Is [7][Health request email] the wrong address for Freedom of Information
requests to Department of Health? If so, please contact us using this
form:

[8]https://www.righttoknow.org.au/change_re...

 

This request has been made by an individual using Right to Know. This
message and any reply that you make will be published on the internet.
More information on how Right to Know works can be found at:

[9]https://www.righttoknow.org.au/help/offi...

 

Please note that in some cases publication of requests and responses will
be delayed.

 

If you find this service useful as an FOI officer, please ask your web
manager to link to us from your organisation's FOI page.

 

 

show quoted sections

TGA FOI, Department of Health

4 Attachments

Dear Kath

 

I hope this email finds you well.

 

I refer to the correspondence sent to you on 19 June 2024 (below) relating
to your request FOI 5203.

 

I write to follow up for a response regarding personal information, as
outlined below.

 

Grateful for your response by COB tomorrow, 3 July 2024.

 

Thank you for your time.

 

Kind regards

Lily

 

Freedom of Information

Therapeutic Goods Administration

Australian Government Department of Health and Aged Care

T: 02 6289 4630 | E: [1][email address]

PO Box 100, Woden ACT 2606, Australia

Web: [2]www.tga.gov.au

 

[3][IMG][4][IMG][5][IMG]

 

Important: This transmission is intended only for the use of the addressee
and may contain confidential or legally privileged information. If you are
not the intended recipient, you are notified that any use or dissemination
of this communication is strictly prohibited. If you receive this
transmission in error please notify the author immediately and delete all
copies of this transmission.

 

The Department of Health acknowledges the Traditional Custodians of
Australia and their continued connection to land, sea and community. We
pay our respects to all Elders past and present. 

 

From: TGA FOI <[email address]>
Sent: Wednesday, June 19, 2024 11:24 AM
To: '[FOI #11522 email]'
<[FOI #11522 email]>
Cc: TGA FOI <[email address]>
Subject: FOI 5203 - Notification of receipt and third party personal
information (for response) [SEC=OFFICIAL]

 

Dear Kath

 

FREEDOM OF INFORMATION REQUEST – NOTIFICATION OF RECEIPT

 

I am writing to notify you that the Therapeutic Goods Administration
(Department of Health and Aged Care) has received your request for access
to documents under the Freedom of Information Act 1982 (FOI Act) as
follows:

 

‘Please provide any data or information provided in the form of report(s),
spreadsheet(s), document(s), email(s) and/or correspondence regarding
Spinal Cord Stimulation revisions provided to the Therapeutic Goods
Administration by Private Healthcare Australia in April and May 2024.’

 

The timeframe for your request is from 01 April 2024 to 31 May 2024.

 

Under section 15(5)(b) of the FOI Act, the agency has 30 calendar days
from the date your request was received in which to provide a decision in
response to your request for access. A decision is currently due on or
before 17 July 2024. Due to the statutory processing time afforded under
the FOI Act in which to provide you with a decision in relation to your
FOI request, we would be grateful if you could please monitor your emails
periodically for updates regarding your request.

 

Where there is requirement to undertake consultation with affected third
parties, this timeframe is extended by a further 30 days. It may also be
extended in certain circumstances, including with your agreement or where
the Department applies to the Office of the Australian Information
Commissioner for an extension.

 

Unless you advise otherwise, draft and duplicate documents, Commonwealth
employee names and contact details of staff below Senior Executive Service
level, internal group email addresses and mobile telephone numbers of all
staff will be excluded from the scope of your request under section
22(1)(a)(ii) of the FOI Act.

 

Disclosure Log Publication:

The TGA is required under section 11C of the FOI Act to publish on its
website, or otherwise make available, documents released to an applicant
in response to an FOI request, unless exceptional circumstances apply. The
TGA publishes these documents on the FOI Disclosure Log at [6]FOI
Disclosure Log | Therapeutic Goods Administration. You can find more
information about the Disclosure Log at [7]OAIC FOI Guidelines |
Disclosure Logs.

 

Personal information:

I note from your request that you have not indicated that you wish to seek
access to the personal information of third parties (e.g. the names and
contact details of individuals, or any information that could reasonably
identify an individual). Seeking this information may require the
Department to consult with the identified individuals. This will increase
the time taken to process your request and the costs involved. As such, we
would be grateful if you would consider removing the personal information
of third parties from the scope of your request. 

 

In addition, please note that if the decision maker decides that you are
liable to pay a charge in relation to your request then this timeframe is
extended pending payment of a deposit. You will be notified by the
Department if you are liable to pay a charge and/or if third party
consultation is required.

 

I would be grateful if you could respond to this email by COB Friday 21
June so that we may continue processing your request.

 

If you have any queries, please contact the FOI team on (02) 6289 4630, or
via email at [8][email address].

 

Kind regards

Emilee

 

Freedom of Information

Karen | Emily | Tara | Christina | Lily| Emilee| Russel

 

Therapeutic Goods Administration

Australian Government Department of Health and Aged Care

T: 02 6289 4630 | E: [9][email address]

PO Box 100, Woden ACT 2606, Australia

Web: [10]www.tga.gov.au

 

Important: This transmission is intended only for the use of the addressee
and may contain confidential or legally privileged information. If you are
not the intended recipient, you are notified that any use or dissemination
of this communication is strictly prohibited. If you receive this
transmission in error please notify the author immediately and delete all
copies of this transmission.

 

The Department of Health and Aged Care acknowledges the Traditional
Custodians of Australia and their continued connection to land, sea and
community. We pay our respects to all Elders past and present.

 

REMINDER: Think before you click! This email originated from outside our
organisation. Only click links or open attachments if you recognise the
sender and know the content is safe.

Dear Department of Health,

 

Please provide any data or information provided in the form of report(s),
spreadsheet(s), document(s), email(s) and/or correspondence regarding
Spinal Cord Stimulation revisions provided to the Therapeutic Goods
Administration by Private Healthcare Australia in April and May 2024.

 

Yours faithfully,

 

Kath

 

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

 

Please use this email address for all replies to this request:

[11][FOI #11522 email]

 

Is [12][Health request email] the wrong address for Freedom of Information
requests to Department of Health? If so, please contact us using this
form:

[13]https://www.righttoknow.org.au/change_re...

 

This request has been made by an individual using Right to Know. This
message and any reply that you make will be published on the internet.
More information on how Right to Know works can be found at:

[14]https://www.righttoknow.org.au/help/offi...

 

Please note that in some cases publication of requests and responses will
be delayed.

 

If you find this service useful as an FOI officer, please ask your web
manager to link to us from your organisation's FOI page.

 

 

show quoted sections

Dear TGA FOI,

Thank you for your email, I confirm I agree to remove the personal information
of third parties from the scope of my request.

Yours sincerely,

Kath

TGA FOI, Department of Health

6 Attachments

Dear Kath

 

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

 

As outlined in the attached letter, pursuant to section 24AB(8) of the
Freedom of Information Act 1982, the processing time for your request has
been set aside to allow for the commencement of the request consultation
period.

 

During the consultation period, the FOI team (in collaboration with the
relevant line area) are available to assist you in revising the scope of
your request so that the practical refusal reason no longer exists, as is
required under the FOI Act. Our aim during the consultation period is to
assist you to define a revised scope which can then be formally submitted
so that processing of your request may continue, and a practical refusal
decision may be avoided.

 

To assist you further, you may also consider submitting a draft revised
scope to us for consideration during the request consultation period. We
will then liaise with the relevant TGA line area on your behalf and
provide you with advice as to whether your amended scope is now considered
reasonable to process.  

 

The request consultation period currently expires on 30 July 2024.
Therefore, we seek your response prior to this date. We would be happy to
extend the consultation process under section 24AB(5) of the FOI Act
should the initial 14 day period not be sufficient to reach agreement. 

 

Please note, once you formally submit a revised scope to us, the
processing clock will recommence and processing of your request will
continue. If the revised scope remains unreasonable to process, the
decision maker may decide to refuse your request under section 24 of the
FOI Act.  

 

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

 

Kind regards

Lily

 

Freedom of Information

Therapeutic Goods Administration

Australian Government Department of Health and Aged Care

T: 02 6289 4630 | E: [1][email address]

PO Box 100, Woden ACT 2606, Australia

Web: [2]www.tga.gov.au

 

[3][IMG][4][IMG][5][IMG]

 

Important: This transmission is intended only for the use of the addressee
and may contain confidential or legally privileged information. If you are
not the intended recipient, you are notified that any use or dissemination
of this communication is strictly prohibited. If you receive this
transmission in error please notify the author immediately and delete all
copies of this transmission.

 

The Department of Health acknowledges the Traditional Custodians of
Australia and their continued connection to land, sea and community. We
pay our respects to all Elders past and present. 

 

show quoted sections

Dear TGA FOI,

Thank you for your email and letter regarding FREEDOM OF INFORMATION REQUEST FOI 5203 and the Request Consultation Process.

I wish to narrow the scope of my request specifically to the data or report about 5,852 spinal cord stimulator implants over a 10-year period to 2021 provided by Private Healthcare Australia (PHA) to the TGA which was referenced by PHA in their contribution to the ABC's Four Corners: Pain Factory story (screened on Monday 8 April 2024) and also referenced in the PHA Press Release titled "Government must stop compelling health insurance funds to pay for ineffective medical care and dangerous, discredited medical devices" on 9 April 2024.

Yours sincerely,

Kath

TGA FOI, Department of Health

2 Attachments

Dear Kath

 

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

 

IMPORTANT: Please include reference to FOI 5203 in your payment.

 

Consultation

As your request relates to the personal, professional, business,
commercial or financial affairs of third parties, pursuant to section 27
and 27A of the FOI Act, the TGA is required to consult with the affected
third parties and provide them an opportunity to make submissions
regarding the release of the documents.

 

Accordingly, under section 15(6) of the FOI Act, and upon payment of a
deposit, the timeframe for processing your request will be extended by 30
days to allow the consultation process to be conducted.

 

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

 

Kind regards

Emily

 

 

Freedom of Information

Therapeutic Goods Administration

Australian Government Department of Health and Aged Care

T: 02 6289 4630 | E: [1][email address]

PO Box 100, Woden ACT 2606, Australia

Web: [2]www.tga.gov.au

 

Important: This transmission is intended only for the use of the addressee
and may contain confidential or legally privileged information. If you are
not the intended recipient, you are notified that any use or dissemination
of this communication is strictly prohibited. If you receive this
transmission in error please notify the author immediately and delete all
copies of this transmission.

 

The Department of Health acknowledges the Traditional Custodians of
Australia and their continued connection to land, sea and community. We
pay our respects to all Elders past and present. 

 

 

"Important: This transmission is intended only for the use of the
addressee and may contain confidential or legally privileged information. 
If you are not the intended recipient, you are notified that any use or
dissemination of this communication is strictly prohibited.  If you
receive this transmission in error please notify the author immediately
and delete all copies of this transmission."

References

Visible links
1. mailto:[email address]
2. http://www.tga.gov.au/

TGA FOI, Department of Health

2 Attachments

Dear Kath

 

I refer to the Estimate of Charges letter sent to you on 25 July 2024
(attached) relating to your request FOI 5203.

 

I write to advise you that your request was deemed withdrawn, as no
payment was received within the legislated timeframe notified in the
Estimate of Charges letter.

 

Should you have any questions regarding this matter, please do not
hesitate to contact the TGA FOI team.

 

Kind regards

 

Freedom of Information

Therapeutic Goods Administration

Australian Government Department of Health and Aged Care

T: 02 6289 4630 | E: [1][email address]

PO Box 100, Woden ACT 2606, Australia

Web: [2]www.tga.gov.au

 

Important: This transmission is intended only for the use of the addressee
and may contain confidential or legally privileged information. If you are
not the intended recipient, you are notified that any use or dissemination
of this communication is strictly prohibited. If you receive this
transmission in error please notify the author immediately and delete all
copies of this transmission.

 

The Department of Health acknowledges the Traditional Custodians of
Australia and their continued connection to land, sea and community. We
pay our respects to all Elders past and present.

 

From: TGA FOI <[email address]>
Sent: Thursday, July 25, 2024 4:39 PM
To: '[FOI #11522 email]'
<[FOI #11522 email]>
Cc: TGA FOI <[email address]>
Subject: FOI 5203 - Notice of Estimate of Charges [SEC=OFFICIAL]

 

Dear Kath

 

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

 

IMPORTANT: Please include reference to FOI 5203 in your payment.

 

Consultation

As your request relates to the personal, professional, business,
commercial or financial affairs of third parties, pursuant to section 27
and 27A of the FOI Act, the TGA is required to consult with the affected
third parties and provide them an opportunity to make submissions
regarding the release of the documents.

 

Accordingly, under section 15(6) of the FOI Act, and upon payment of a
deposit, the timeframe for processing your request will be extended by 30
days to allow the consultation process to be conducted.

 

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

 

Kind regards

Emily

 

 

Freedom of Information

Therapeutic Goods Administration

Australian Government Department of Health and Aged Care

T: 02 6289 4630 | E: [3][email address]

PO Box 100, Woden ACT 2606, Australia

Web: [4]www.tga.gov.au

 

Important: This transmission is intended only for the use of the addressee
and may contain confidential or legally privileged information. If you are
not the intended recipient, you are notified that any use or dissemination
of this communication is strictly prohibited. If you receive this
transmission in error please notify the author immediately and delete all
copies of this transmission.

 

The Department of Health acknowledges the Traditional Custodians of
Australia and their continued connection to land, sea and community. We
pay our respects to all Elders past and present. 

 

 

"Important: This transmission is intended only for the use of the
addressee and may contain confidential or legally privileged information. 
If you are not the intended recipient, you are notified that any use or
dissemination of this communication is strictly prohibited.  If you
receive this transmission in error please notify the author immediately
and delete all copies of this transmission."

References

Visible links
1. mailto:[email address]
2. http://www.tga.gov.au/
3. mailto:[email address]
4. http://www.tga.gov.au/