Good morning

FREEDOM OF INFORMATION REQUEST - NOTIFICATION OF RECEIPT

I am writing to notify you that the Department of Health (department) received your request on 6 November 2021 for access to documents under the Freedom of Information Act 1982 (Cth) (FOI Act) being:

The Health Products Regulations Group (HPRG) resides in Australia's Department of Health. The HPRG Executive is:
a. Deputy Secretary, Adjunct Prof John Skerritt b. Principal Legal and Policy Adviser, Jenny Francis c. First Assistant Secretary, Medicines Regulation Division, Dr Jane Cook d. First Assistant Secretary, Medical Devices and Product Quality Division, Tracey Duffy e. First Assistant Secretary Regulatory Practice and Support Division, Gillian Mitchell
Please provide the job description, role, responsibilities and duties of each member of the HPRG executive. This request is made in accordance with Australia's Freedom of Information Act.

The statutory timeframe for processing your request is 30 calendar days within which a decision on access to the requested documents is to be notified.

The department may impose a charge for the work involved in providing access to the documents. If this request attracts a charge you will be notified in writing.

Unless you advise otherwise, draft and 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 under s22(1)(a)(ii) of the FOI Act.
Request for extension of time

You can contact the FOI Unit via email at [email address], should you have any questions.

Kind regards

FOI Officer
Freedom of Information Section

Legal & Assurance Division |  Corporate Operations Group
Legal Advice & Legislation Branch
Australian Government Department of Health
E: [Health request email] 
GPO Box 9848, Canberra ACT 2601, Australia

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. 

If you receive this email in error, please delete it and contact the sender immediately.

-----Original Message-----
From: Jaay-H <[FOI #8073 email]>
Sent: Saturday, 6 November 2021 10:54 PM
To: FOI <[email address]>
Subject: Freedom of Information request - HPRG executive role, responsibilities and duties

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,
The Health Products Regulations Group (HPRG) resides in Australia's Department of Health. The HPRG Executive is:
a. Deputy Secretary, Adjunct Prof John Skerritt b. Principal Legal and Policy Adviser, Jenny Francis c. First Assistant Secretary, Medicines Regulation Division, Dr Jane Cook d. First Assistant Secretary, Medical Devices and Product Quality Division, Tracey Duffy e. First Assistant Secretary Regulatory Practice and Support Division, Gillian Mitchell Please provide the job description, role, responsibilities and duties of each member of the HPRG executive. This request is made in accordance with Australia's Freedom of Information Act.
Yours faithfully,
Jaay-H

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Please use this email address for all replies to this request:
[FOI #8073 email]

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

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"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."

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Dear Jaay-H

Thank you for your email below dated 6 November 2021 as follows:

“The HPRG Executive is:
a. Deputy Secretary, Adjunct Prof John Skerritt
b. Principal Legal and Policy Adviser, Jenny Francis
c. First Assistant Secretary, Medicines Regulation Division, Dr Jane Cook
d. First Assistant Secretary, Medical Devices and Product Quality Division, Tracey Duffy
e. First Assistant Secretary Regulatory Practice and Support Division, Gillian Mitchell

Please provide the job description, role, responsibilities and duties of each member of the HPRG executive.”

At the outset, I note that under the FOI Act, the TGA is not required to create a document or make copies of information which is publicly available.

However, to assist you, I would like to provide you with some publicly available information which is relevant to your request.

Publicly available information

The following page on the TGA website, provides information about Adjunct Professor John Skerritt and his role and responsibilities as the Deputy Secretary of the Health Products Regulation Group (HPRG):

www.tga.gov.au/prof-john-skerritt

Each member of the TGA Executive is responsible for leadership and management of their Branch or Division. The following page on the TGA website outlines the roles and responsibilities of each member of the TGA Executive:

www.tga.gov.au/structure

The organisational chart on the Department of Health website, shows each member of the TGA Executive and how they fit within the overall structure of the Department:

www.health.gov.au/about-us/who-we-are/or...

Information about the role of the Senior Executive Service can be found on the Australian Public Service Commission website:

https://www.apsc.gov.au/working-aps/aps-...

As the information you have requested is publicly available, I consider your query dated 6 November 2021 to be withdrawn.

Should you seek additional information, you are welcome to submit another FOI request, outlining the specific documents you seek access to.

Kind regards

Karen

Freedom of Information
David Gobbitt | Karen Bedford | Tara Condon |Christina Bush
Emily May | Nicole Yu | Alison McCook l Adam Horrigan

Therapeutic Goods Administration
Australian Government Department of Health
T: 02 6289 4630 | E: [email address]
PO Box 100, Woden ACT 2606, Australia
Web: 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.

-----Original Message-----
From: Jaay-H <[FOI #8073 email]>
Sent: Saturday, 6 November 2021 10:54 PM
To: FOI <[email address]>
Subject: Freedom of Information request - HPRG executive role, responsibilities and duties

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,
The Health Products Regulations Group (HPRG) resides in Australia’s Department of Health. The HPRG Executive is:
a. Deputy Secretary, Adjunct Prof John Skerritt b. Principal Legal and Policy Adviser, Jenny Francis c. First Assistant Secretary, Medicines Regulation Division, Dr Jane Cook d. First Assistant Secretary, Medical Devices and Product Quality Division, Tracey Duffy e. First Assistant Secretary Regulatory Practice and Support Division, Gillian Mitchell Please provide the job description, role, responsibilities and duties of each member of the HPRG executive. This request is made in accordance with Australia’s Freedom of Information Act.
Yours faithfully,
Jaay-H

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

Please use this email address for all replies to this request:
[FOI #8073 email]

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

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

"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."

hide quoted sections

​Dear Jaay-H,

FREEDOM OF INFORMATION REQUEST – NOTIFICATION OF RECEIPT

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

              “The Health Products Regulations Group (HPRG) resides in
Australia’s Department of Health.  The HPRG Executive is:

a.  Deputy Secretary, Adjunct Prof John Skerritt

b.  Principal Legal and Policy Adviser, Jenny Francis

c.  First Assistant Secretary, Medicines Regulation Division, Dr Jane Cook

d.  First Assistant Secretary, Medical Devices and Product Quality
Division, Tracey Duffy

e.  First Assistant Secretary Regulatory Practice and Support Division,
Gillian Mitchell

Please provide the job description, role, responsibilities and duties of
each member of the HPRG executive.

We Initially provided you with public information. You have since
clarified:

A position description is a key document related to the employment of each
Australia public servant.  The document describes the job title, APS
classification, position number, position reports to, and location
relevant to the employment position.  The document generally describes
things like the position's primary purpose, selection criteria, essential
requirements/job specific capabilities, key duties and responsibilities. I
appreciate the links you provided however the documents I requested are
specific documents that do not appear to be contained in the links.  I
will be grateful if you can help provide the requested documents for each
member of the HPRG executive.”

Under section 15(5)(b) of the FOI Act, the agency has 30 calendar days
after 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 24 December 2021.

However, 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.

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.

PROCESSING YOUR REQUEST

To assist us to streamline the processing of your request we ask you to
consider and respond to the following questions.

 1. Duplicate Documents

Under section 4(1) of the FOI Act, the definition of a document includes
‘any copy, including an part of any copy, of a reproduction or duplicate’.
Confirmation that you are not seeking duplicate documents may enable more
timely and less costly processing of your request.

Can you please clarify if you are seeking duplicate copies, either in part
or in full, as part of your request?

If you are not seeking access to duplicate documents, you can simply
respond: ‘no duplicates requested’.

We look forward to hearing from you by COB Monday 6 December 2021, if
possible.

If you have any queries, please contact the FOI team on (02) 6289 4630, or
via email at [1][email address].

Kind regards
Christina

Freedom of Information

Therapeutic Goods Administration

Australian Government Department of Health

T: 02 6289 4630 | E: [2][email address]

PO Box 100, Woden ACT 2606, Australia

Web: [3]www.tga.gov.au

[4][IMG][5][IMG][6][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.

"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. mailto:[email address]
3. http://www.tga.gov.au/
4. https://www.facebook.com/TGAgovau/
5. https://twitter.com/TGAgovau
6. https://www.youtube.com/channel/UCem9INJ...

​Dear Jaay-H,

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

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

Kind regards

Tara

Freedom of Information

David | Karen | Tara |Christina
Emily | Alison l Adam l Isobel

Therapeutic Goods Administration

Australian Government Department of Health

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/

Dear Jaay-H

The TGA acknowledges receipt of your request for a waiver of changes
associated with processing your FOI request (FOI 3363). The decision maker
is currently reviewing your request. Please note that the TGA has 30 days
from receipt of your email to make a decision on whether or not to waive
the charges.  Therefore, a decision is due on or before 16 January 2022.

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

Kind regards

Christina

Freedom of Information

David | Karen | Tara |Christina
Emily | Nicole | Alison l Adam l Isobel

Therapeutic Goods Administration

Australian Government Department of Health

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/

Dear Jaay-H,

I am writing to you in relation to FOI request 3363, in which you are seeking access to documents containing position descriptions of TGA executive level staff.

It has come to our attention that the timeframe for a decision to be provided to you in this matter has been exceeded due to an administrative error, and accordingly your request is considered to be a ‘deemed access refusal decision’.

Please accept our apologies for this occurrence. In order to resolve this issue, we provide the following options for your consideration.

Option 1 – Withdrawal of current request and submitting a new request

We consider the most expeditious way forward in this matter is for you to withdraw your current request (FOI 3363) and make a new request for the same documents as follows:

‘Under the Commonwealth FOI Act, I request access to position descriptions for the following members of the Health Products Regulations Group (HPRG):
a. Deputy Secretary, Adjunct Prof John Skerritt
b. Principal Legal and Policy Adviser, Jenny Francis
c. First Assistant Secretary, Medicines Regulation Division, Dr Jane Cook
d. First Assistant Secretary, Medical Devices and Product Quality Division, Tracey Duffy
e. First Assistant Secretary Regulatory Practice and Support Division, Gillian Mitchell.

A position description is a key document related to the employment of each Australia public servant. The document describes the job title, APS classification, position number, position reports to, and location relevant to the employment position. The document generally describes things like the position's primary purpose, selection criteria, essential requirements/job specific capabilities, key duties and responsibilities.

Excluding personal information.’

We would then propose to provide you with a decision letter (and the requested documents) by no later than seven (7) calendar days. Further, we propose to provide you with the requested documents in their entirety, apart from the personal information of any individuals contained within the documents, e.g. excluding names and phone numbers.

Should you wish to proceed with option 1, the delegate has agreed not to impose charges in relation to your request.

Option 2 – Seeking review of the deemed access refusal decision by the Information Commissioner

As noted above, as the statutory timeframe for your request has been exceeded, you are within your rights to seek review of FOI 3363 by the Information Commissioner (IC).

In this situation, it is likely that the IC would conduct a review of this request and submissions would be required from both the TGA and yourself. The TGA would not be able to provide you with access to the requested documents until the review has commenced, in accordance with section 55G of the Freedom of Information Act 1982 (the FOI Act).

Should you wish to proceed with option 2, we are unable to provide an estimated timeframe for when you would receive the documents, as we will be guided by the IC.

Next steps

From the viewpoint of expediting your request and providing you with the documents as soon as possible, we suggest that you proceed with option 1.

Accordingly, we would be grateful if you could advise as soon as possible whether you agree to proceed with option 1, i.e. you agree to withdraw FOI 3363 and make a new request for the same documents, excluding personal information, which the TGA will process within seven (7) calendar days, at no cost to you, as the delegate has agreed not to impose charges.

Thank you again for your patience and understanding in this matter, and we look forward to your early response.

Freedom of Information

Therapeutic Goods Administration
Australian Government Department of Health
T: 02 6289 4630 | E: [email address]
PO Box 100, Woden ACT 2606, Australia
Web: 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.

-----Original Message-----
From: Jaay-H <[FOI #8073 email]>
Sent: Friday, 17 December 2021 5:00 PM
To: TGA FOI <[email address]>
Subject: Re: [SEC=OFFICIAL] FOI 3363 - Notice of Estimate of Charges

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 TGA FOI

Under section 8 of the Charges Regulations an agency has discretion to not impose a charge. I contend that the charge should not be imposed in accordance with Section 29(1)(c) of the FOI Act. Please take into account that giving access to the documents in question is in the general public interest and in the interest of a substantial section of the public. The public interest in this case is innate and profound. In September the Health Products Regulation Group (HPRG) promulgated new restrictions on prescribing ivermectin for covid-19. This decision directly impacts ever single person in Australia, approximately 26 million people.

At the time of HPRG's decision, there was considerable very credible research demonstrating ivermectin may have a role in covid-19 prevention and treatment. The FOI Act entitles the Australian public to scrutinise, discuss, comment and review the HPRG’s decisions. The objects of the FOI Act enable this to increase public participation in government proceedings with a view to promoting better-informed decision making.

Yours sincerely,

Jaay-H

-----Original Message-----

​Dear Jaay-H,

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

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

Kind regards

Tara

Freedom of Information

David | Karen | Tara |Christina
Emily | Alison l Adam l Isobel

Therapeutic Goods Administration

Australian Government Department of Health

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/

-------------------------------------------------------------------
Please use this email address for all replies to this request:
[FOI #8073 email]

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:
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.

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

"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."

hide quoted sections