You are here

TGA Internet site archive

The content on this page and other TGA archive pages is provided to assist research and may contain references to activities or policies that have no current application. See the full archive disclaimer.

TGA Transparency Review consultation process outline

2 March 2011

The Panel undertaking the Review has agreed to seek input from the community by calling for written submissions, and holding a limited number of face-to-face meetings in metropolitan and rural locations.

Consultation process outline

Consultation Process Outline as finalised by the Review Panel at its meeting on 10 February 2011.

Timing Action
22 December 2010 Advance Notice of Call for Input on TGA and DoHA websites (together with short paper)
December 2010 Subscribers to TGA-UPDATE received notification of website upload
15 January 2011 Advertise Call for Input in national press
17 January 2011 Mail-out to stakeholders
10 February 2011 2nd Panel Meeting, Canberra
11 February 2011 Written submission period closes
TBA February 2011 Possible meeting with S/T Health Departments
21 February to 4 March 2011 Face-to-face meetings
7 to 11 March 2011 Additional meetings if required
23 March 2011 3rd Panel Meeting, Canberra
13 April 2011 4th Panel meeting, Canberra (or teleconference)
29 April 2011 Report

Call for written submissions

  • On 22 December 2010, advice of a 'Call for Input' (attached) was placed on the TGA website, the Department of Health and Ageing website, and emailed to Panel members.
  • On Saturday 15 January 2011, advertisements will be placed in the Public Notices section of 'The Australian' and the major capital city daily newspapers seeking submissions to the Review and advising the closing date for written submissions: Friday 11 February 2011 (See Attachment A).
  • A mail-out of a letter from Professor Pearce AO (copy at Attachment B) inviting submissions will coincide with the advertisements. The TGA stakeholder database of over of 370 individuals and organisations will be used and suggestions made by Panel members are being added to the database. The letter will note that face-to-face meetings will be held and details of these will be on the TGA website by Thursday 3 February 2011.
  • Some Panel members (CHF in particular) have advised they will use their networks to ensure wide circulation of Professor Pearce's letter of invitation.
  • All members of the TGA Advisory Committees have been invited to make a submission by 28 February 2011. All written submissions will be acknowledged, and sent to Panel members via a weekly email, and will be progressively uploaded on the TGA website. The Secretariat will also analyse the submissions, collate the recommendations and will make this available to Panel members.

Public meetings

Details of the public meetings were added to the website on Thursday 3 February 2011, giving dates, venues and times for each location, and options for registration (i.e. by email, or phone).

All Panel members may attend each meeting. It was agreed at the 7 December 2011 meeting that, at a minimum, each stakeholder group would be represented by 1 Panel member, at each meeting. However, depending on the final agreed format for the meetings, additional Panel member representation may be necessary to ensure a successful outcome.

Venues for up to 100 people, seated café-style, have been tentatively booked for the following locations and dates:

  • Parramatta, NSW: Wednesday, 23 February 2011
  • Albury, NSW: Monday, 28 February 2011
  • Melbourne: Tuesday, 1 March 2011
  • Perth: Friday, 4 March 2011.

It was agreed at the 10 February meeting that all Panel members would actively encourage participation in these meetings through their networks.

In addition to the public meetings, the Parliamentary Secretary has invited State and Territory Health Ministers to nominate officials for a meeting with jurisdictions on the Review. Further meetings with specific interest groups may be necessary to ensure that a representative sample of stakeholders have the opportunity to put their views to the Panel.

Consumer representatives have noted their preference for separate consumer consultations and surveys.

The Agenda for the public meetings is detailed below:

Public meeting agenda

09:30
Introduction and purpose of Consultation - Prof Dennis Pearce
- Organisational arrangements

Presentation on the TGA - Stephen Dellar
- what is the TGA and its responsibility;
- TGA expectations from this review

Panel expectations of this consultation - Panel member (standard script)

10:00
Group discussion - Panel to facilitate

11:00
Tea/coffee break

11.20
Discussion reports and open forum - Prof Dennis Pearce

12:30
Meeting close

12:30 - 13:00
Opportunity for one-to-one discussions, with either the Chair or a Panel member, for additional comment, especially in relation to private concerns.

Group discussion questions

Consumers

  • What type of information should TGA provide about medicines, supplements and devices;
  • How adequate is the information provided by the TGA on the safety, quality and efficacy of medicines and the safety, quality and performance of medical devices included on the Australian Register of Therapeutic Goods (ARTG);
  • How easy is it to access this information;
  • In what way should that information be provided to consumers - e.g. on the internet or other electronic media; through a doctor, pharmacist or health professional; in a brochure or handout about a specific medicine or a therapeutic device;
  • How should information provided by TGA best be updated and who should be responsible for this;
  • There is limited capacity for manufacturers of therapeutic goods to advertise their availability to the general public. The TGA has a role in ensuring that advertisements are truthful. Are you aware of seeing any advertisements for therapeutic goods (e.g. on TV, in magazines etc);
  • Do you know how to make a complaint about an advertisement for a therapeutic good? Have you ever done so; and if yes, comment on your experience with the process.
  • What other issues relevant to the interests of consumers and falling within the terms of reference should be considered by the review Panel.

Health professionals

  • How adequate is the information provided by the TGA on the safety, quality and efficacy of medicines and the safety, quality and performance of medical devices included on the Australian Register of Therapeutic Goods (ARTG);
  • Consider in particular the information provided in:
    • Australian Public Assessment Reports for prescription medicines;
    • Approved Product Information;
    • Consumer Medicine Information;
    • Public summary documents on the ARTG;
    • TGA Advisories and Medicines Safety Updates;
  • How easy is it to access this information;
  • Have you encountered problems in regard to the transparency of TGA processes and decision- making;
  • What can be done to make the advertising processes relating to therapeutic goods more transparent;
  • What other issues relevant to the interests of health professionals and falling within the terms of reference should be considered by the review Panel.

Producers and marketers of therapeutic goods

  • In what ways could TGA provide greater assistance in the evaluation and registration, listing or marketing processes;
  • Consider in particular:
    • the adequacy of guidelines; and
    • the provision of information relating to the making, withdrawal or refusal of applications (either to applicants or publicly or both);
  • What information additional to that presently made publicly available by TGA could be released without raising confidentiality issues;
  • Any issues that you have encountered in regard to the transparency of TGA processes and decision-making;
  • The scope and significance to your activities of commercial in confidence limitations on access to information;
  • What can be done to make the advertising processes relating to therapeutic goods more transparent;
  • What other issues relevant to the interests of producers and marketers and falling within the terms of reference should be considered by the review Panel.

Media representatives

  • The timeliness, quality and utility of information provided in response to enquiries and/or Freedom of Information requests;
  • What are your information needs;
  • Are there ways the TGA could meet your needs more effectively, and if so, how; and
  • What can be done to make the advertising processes relating to therapeutic goods more transparent.

Attachment A: Copy: Advertisement for national daily papers, Saturday 15 January 2011

Review to improve transparency of the Therapeutic Goods Administration (TGA)

The Parliamentary Secretary for Health and Ageing, the Hon Catherine King MP, has initiated a comprehensive review of the way the TGA communicates its regulatory processes and decisions.

A Review Panel of consumer, health professional and therapeutic goods industry representatives is being chaired by Professor Dennis Pearce AO.

The Panel is to report at the end of April 2011 on:

  • opportunities to provide more information about products on the market;
  • how the public can improve its understanding of the ways new products are assessed and products on the market are monitored;
  • the timing for making information available about new products;
  • the type of information and how it is made public by comparable overseas regulators;
  • constraints (or barriers) to the release of further information, such as implications for public health and safety;
  • how the material can be published - e.g. use of the internet and other publication methods; and
  • opportunities for the public to access more information about the advertising of therapeutic goods.

For more information visit the TGA website: Call for input: Review to improve transparency of the Therapeutic Goods Administration (TGA)

If you would like to make a comment or a submission you can either:

email it to the Review Secretariat at transreviewpanel@tga.gov.au

or mail it to:

Transparency Review Secretariat
Therapeutic Goods Administration
PO Box 100
WODEN ACT 2606

Submissions must reach the Secretariat no later than Friday 11 February 2011. Please note that any comment or submissions you provide will be made available to the public.


Attachment B: Copy: Professor Pearce's invitation letter for the mail out

Dear Sir/Madam

As the Chair of the Panel to Review the Transparency of the Therapeutic Goods Administration (TGA), I am writing to invite you to make a submission to the Review.

The review was announced by the Parliamentary Secretary for Health and Ageing, the Hon Catherine King MP on 16 November 2010. The review focuses on the way in which the Therapeutic Goods Administration (TGA) communicates its regulatory processes and decisions. The review will focus on improving the TGA's transparency.

The purpose of the project is to improve public knowledge of the TGA's regulatory decision-making and to enhance public understanding of the benefits and risks of therapeutic goods so that the Australian community can understand how the TGA operates and the reasons for its key decisions.

The Review Panel includes consumer, health professional and therapeutic goods industry representatives and I have been asked to report the panel's findings to the Parliamentary Secretary for Health and Ageing by the end of April 2011.

The Panel has been asked to report on:

  • opportunities to provide more information about products on the market;
  • how the public can improve its understanding of the ways new products are assessed and products on the market are monitored;
  • the timing for making information available about new products;
  • the type of information and how it is made public by comparable overseas regulators;
  • constraints (or barriers) to the release of further information, such as implications for public health and safety;
  • how the material can be published - e.g. use of the internet and other publication methods; and
  • opportunities for the public to access more information about the advertising of therapeutic goods.

For the full Terms of Reference, membership of the Panel and to read comments already provided to the panel by some individuals and organisations please visit the TGA website at Transparency review of the TGA

In particular, the Panel would like to hear from the general public:

  • about instances where it could have been useful for you to have had access to better information about your medicine, supplement or device;
  • about the type of information that could have helped you;
  • the way you would like to access that information - e.g. on the internet or other electronic media; through your doctor, pharmacist or health professional; in a brochure or handout about a specific medicine or a therapeutic device;
  • whether you have ever looked for information provided by the TGA and, if so, where did you find it and was it helpful; and
  • what other information you use.

If you are a health professional the Panel would like your comments on:

  • information provided by the TGA on the safety, quality and efficacy of medicines and medical devices included on the Australian Register of Therapeutic Goods (ARTG) including:
    • Australian Public Assessment Reports for prescription medicines;
    • Approved Product Information;
    • Consumer Medicine Information;
    • Public summary documents on the ARTG;
    • TGA Advisories and Medicines Safety Updates; and
  • any problems that you have encountered in regard to the transparency of TGA processes and decision making.

If you participate in production or marketing of therapeutic goods, please consider providing comment on:

  • what ways you think the TGA could provide greater assistance to you in the evaluation and registration, listing or marketing processes; and
  • any issues that you have encountered in regard to the transparency of TGA processes and decision making.

If you work in the media comments would be appreciated on the timeliness, quality and utility of information provided in response to inquiries and/or Freedom of Information requests.

You are invited to comment on any matters relevant to the Terms of Reference. Please note that all submissions will be made available on the TGA website.

To make a comment or a submission you can either email it to the Review Secretariat at transreviewpanel@tga.gov.au OR mail it to:

Transparency Review Secretariat
Therapeutic Goods Administration
PO Box 100
WODEN ACT 2606

Submissions must reach the Secretariat no later than Friday 11 February 2011.

The Panel will hold a limited number of public meetings in late February and March 2011 and details about these will be provided on the TGA website on Thursday 3 February 2011.

I look forward to receiving your views.

Yours sincerely

Dennis Pearce AO
13 January 2011